<DOC>
[107 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:78072.wais]
S. Hrg. 107-321
NUCLEAR REGULATORY COMMISSION:
FISCAL YEAR 2002 PROGRAMS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON CLEAN AIR, WETLANDS,
PRIVATE PROPERTY, AND NUCLEAR SAFETY
OF THE
COMMITTEE ON
ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
ON
OVERSIGHT OF THE PROGRAMS OF THE U.S. NUCLEAR REGULATORY COMMISSION FOR
FISCAL YEAR 2002
__________
MAY 8, 2001
__________
Printed for the use of the Committee on Environment and Public Works
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COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
one hundred seventh congress
first session
BOB SMITH, New Hampshire, Chairman
HARRY REID, Nevada, Ranking Democratic Member
JOHN W. WARNER, Virginia MAX BAUCUS, Montana
JAMES M. INHOFE, Oklahoma BOB GRAHAM, Florida
CHRISTOPHER S. BOND, Missouri JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio BARBARA BOXER, California
MICHAEL D. CRAPO, Idaho RON WYDEN, Oregon
LINCOLN CHAFEE, Rhode Island THOMAS R. CARPER, Delaware
ROBERT F. BENNETT, Utah HILLARY RODHAM CLINTON, New York
BEN NIGHTHORSE CAMPBELL, Colorado JON S. CORZINE, New Jersey
Dave Conover, Republican Staff Director
Eric Washburn, Democratic Staff Director
------
Subcommittee on Clean Air, Wetlands,
Private Property, and Nuclear Safety
GEORGE V. VOINOVICH, Ohio, Chairman
JAMES M. INHOFE, Oklahoma JOSEPH I. LIEBERMAN, Connecticut
MICHAEL D. CRAPO, Idaho THOMAS R. CARPER, Delaware
BEN NIGHTHORSE CAMPBELL, Colorado HILLARY RODHAM CLINTON, New York
JON S. CORZINE, New Jersey
(ii)
C O N T E N T S
----------
Page
MAY 8, 2001
OPENING STATEMENTS
Carper, Hon. Thomas R., U.S. Senator from the State of Delaware.. 48
Corzine, Hon. Jon S., U.S. Senator from the State of New Jersey.. 34
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma... 3
Reid, Hon. Harry, U.S. Senator from the State of Nevada, prepared
statement...................................................... 15
Voinovich, Hon. George V., U.S. Senator from the State of Ohio... 1
WITNESSES
Meserve, Richard A., chairman, Nuclear Regulatory Commission;
accompanied by: Commisioner Diaz, Commissioner Dicus,
Commissioner McGaffigan, and Commissioner Merrifield........... 5
Prepared statement........................................... 50
Responses to additional questions from:
Senator Clinton.......................................... 65
Senator Corzine.......................................... 78
Senator Reid............................................. 61
Senator Voinovich........................................ 149
OPENING STATEMENTS
Colvin, Joe F., president and CEO, Nuclear Energy Institute...... 26
Prepared statement........................................... 151
Responses to additional questions from Senator Reid.......... 159
Fetter, Steven, managing director, Global Power Group, FITCH
IBCA,.......................................................... 33
Prepared statement........................................... 188
Press releases............................................... 190
Jones, Gary, associate director for Energy, Resources, and
Science Issues, U.S. General Accounting Office................. 31
Prepared statement........................................... 184
Kingsley, Oliver D., Jr., president and chief nuclear officer,
Exelon Corporation............................................. 30
Prepared statement........................................... 177
Responses to additional questions from Senator Reid.......... 183
Lochbaum, David, nuclear safety engineer, Union of Concerned
Scientists..................................................... 28
Prepared statement........................................... 166
Responses to additional questions from Senator Reid.......... 176
ADDITIONAL MATERIALS
Analysis, 10 CFR Parts 20, 32, and 35............................ 148
Articles:
Cost of Chernobyl Nuclear Disaster Soars in New Study........ 174
Turning the Tide on Nuclear Engineering Undergraduate
Enrollment................................................. 10
Letters:
Price-Anderson Act renewal................................... 19
Indian Point Unit............................................ 76
Union of Concerned Scientists................................ 171
Memorandum, Steam Generator Tube Integrity Issues................ 164
Timeline, Nuclear Waste Repository Chronology.................... 46
NUCLEAR REGULATORY COMMISSION: FISCAL YEAR 2002 PROGRAMS
----------
TUESDAY, MAY 8, 2001
U.S. Senate,
Committee on Environment and Public Works,
Subcommittee on Clean Air, Wetlands,
Private Property, and Nuclear Safety,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:30 a.m. in
room 628, Senate Dirksen Building, Hon. George V. Voinovich
(chairman of the subcommittee) presiding.
Present: Senators Voinovich, Inhofe, Corzine, Carper, and
Reid.
OPENING STATEMENT OF HON. GEORGE V. VOINOVICH,
U.S. SENATOR FROM THE STATE OF OHIO
Senator Voinovich. The hearing will come to order. Good
morning.
Today's hearing continues our ongoing oversight of the
Nuclear Regulatory Commission. Now, this oversight began by my
predecessor, Senator Jim Inhofe, in 1998, and it is the fourth
oversight hearing in the last 4 years. I think Senator Inhofe
deserves a lot of credit for helping to turn the regulatory
process around at the NRC.
Everyone I've met this year credits you, Senator Inhofe,
for your oversight hearings and for the change to the risk-
based regulations at the NRC and for focusing the NRC on
processing relicense applications quickly.
It's amazing. Everywhere I go they brag about Jim and what
he's done. I think that it's nice that people recognize the
contribution that you have made.
These changes at the NRC have helped create new interest in
nuclear energy, including the first discussions in years about
building new nuclear facilities. It is my intention as chairman
to continue this strong oversight to ensure that nuclear energy
remains a viable energy option and an important part of our
national fuel mix.
Over the last 40 years, nuclear energy has proven to be a
safe, reliable, and clean source of energy. It currently
produces 20 percent of our electricity, and since 1973 nuclear
energy has avoided over 62 million tons of sulfur dioxide, over
32 million tons of nitrogen, and over 2.6 billion tons of
carbon, which would have been released by fossil fuel plants
producing the same amount of electricity.
While the United States is 20 percent dependent on nuclear
energy, we are falling behind worldwide. France is 76 percent
dependent on nuclear energy, and Japan is approximately 50
percent reliant on nuclear energy.
The Energy Information Administration predicts that we will
need about a 30 percent increase in electrical generation by
the year 2015. Currently, we are dependent on fossil fuels,
coal, oil, gas, and will be for the conceivable future. Nuclear
is and will be the next best alternative. Together, solar and
wind provides less than \1/10\ of 1 percent of U.S. energy
needs, and I've heard some of my colleagues talking about the
wind and the sun and the water, but the fact of the matter is
that the demand for energy in this country cannot be satisfied
with what I just talked about. That doesn't mean that we
shouldn't be moving forward on all of that in alternative
sources of energy, but the fact is we're going to need to
produce more energy in this country and it's going to be a
while before some of these other ideas that folks have are
going to be able to get to a point where it's going to make a
real dent on that demand.
If we're serious about protecting our environment and
providing safe, reliable, and affordable electricity to all
Americans, we need to improve how we burn fossil fuels, promote
efficiency, and increase the development of nuclear energy for
today and the foreseeable future. We also need to continue
investing in renewables, as I said, such as solar and wind to
make them cost effective and feasible, not for today or
tomorrow but for use at some point in the future.
In order to continue to rely on nuclear energy and increase
its use, the NRC must accomplish the following:
No. 1, most important is public safety. Nuclear power has a
great safety record and we must continue to improve upon it.
No. 2, we must do everything we can about the human capital
crisis affecting the nuclear industry. At the NRC, for every
employee under the age of 30, there are six employees over the
age of 60. The private industry and the nuclear Navy are having
similar problems, so we've got a problem right across the board
in terms of nuclear engineering.
No. 3, the NRC must continue examining the relicensing
process. The first two renewals occurred on schedule. The NRC
must examine the procedures to make sure they can process
multiple applications at the same time.
No. 4, the NRC must continue to improve the regulatory
certainty. Over the last few years, the NRC has made progress
in delivering certainty to the enforcement and regulatory area
through the risk-based approach. That needs to continue.
No. 5, the NRC must address how we can get more nuclear
generation. Can existing facilities increase generation? Is
that possible? What can the Government do to encourage the
building of new nuclear units?
No. 6, how do we address the waste issue? The Federal
Government has a legal and moral obligation to solve the waste
issue as quickly as possible. Nuclear ratepayers across the
country have paid $15.8 billion--that's $15.8 billion--in
additional taxes to the U.S. Government for the building of a
high-level waste storage facility. We must stop the politics on
this issue and get it resolved, and hopefully that will happen
by the end of this year.
I hope to examine these issues in today's hearings, but we
will continue to examine these issues in the weeks and months
to come. In addition to today's hearings, we will have another
hearing addressing nuclear radiation standards. This is an
important issue, as we discuss possible storage at Yucca
Mountain, the decommissioning of facilities, and the potential
contact people will have with radiation sources.
I am a cosponsor of the Murkowski energy policy bill,
Senate 388, and I am examining the nuclear provisions of that
legislation. Since the Nuclear Regulatory Commission falls
under the jurisdiction of this subcommittee, I will be
introducing my own legislation to complement Senator
Murkowski's to encourage and expand the safe use of nuclear
energy. I happen to believe that we need to get going in terms
of producing more energy in this country. The public has to
know that there's going to be some light at the end of the
tunnel, and it seems to me we've got to get moving as quickly
with some of this legislation as we can.
Senator Inhofe, we may just have to pull out a couple of
these pieces of it and fast track them before we do the whole
watermelon as being conceived right now by the Vice President
and Murkowski and--this place runs very slowly.
[Laughter.]
Senator Voinovich. And the public needs to know, you know,
that we've got a problem in the country right now, and energy
costs are one of the reasons why we are having a funk in the
economy today, and people have got to believe that things are
going to get better.
Our witnesses today include a broad spectrum of
viewpoints--the chairman and commissioners of the NRC industry,
public interest, the GAO, and a Wall Street analyst. I look
forward to their testimony and working with my colleagues on
these issues.
I will now call on Senator Inhofe for his opening
statement.
Senator Inhofe.
OPENING STATEMENT OF HON. JAMES M. INHOFE,
U.S. SENATOR FROM THE STATE OF OKLAHOMA
Senator Inhofe. Thank you, Mr. Chairman.
I endorse everything that you said. In fact, my opening
statement included a lot of the same things, perhaps stated a
little bit differently. And I appreciate your compliments, but
I think that each one of the commissioners at this table would
agree that any bureaucracy--and, of course, NRC is a
bureaucracy--that goes without any oversight hearings for a
period of 10 years, that it does tend to get a little sloppy.
And we've talked about this and we've seen some very good
improvements. I compliment the first panel for some of the
changes they have made.
Last week, the Environmental Committee had a hearing on the
science of global climate change and issues related to reducing
net greenhouse gas emissions. In that hearing, I outlined my
strong support for expanding the nuclear energy, as I have for
many years. With nuclear energy, our Nation wins on many
levels. We have an inexpensive and reliable source of energy.
Increased nuclear capacity will contribute to more stable
energy prices. This is one of the problems that we've had is
the unpredictability that's out there.
As the Nation takes steps to increase our nuclear capacity,
we'll put our Nation in a position to address greenhouse gases
in the atmosphere should that science become a reality.
A lot of people don't realize that nuclear doesn't emit any
CO<INF>2</INF>, so this is something that we have out there
that we can talk to various organizations who otherwise might
have found some objection to it.
It is my understanding that some States, such as
Connecticut, have gone--they're up to 47 percent right now, so
there is a lot of potential there.
I'm eager to see the specifics of the policy when it comes
out, the recommendations that are made to the President when he
comes out with the national energy policy and how it fits with
Murkowski's bill. I feel that there's going to be an expansion
of nuclear energy in that program.
I would like for those who are testifying to include--and
I'll have some questions about this--first, how can the NRC use
the lessons that we've learned during their previous reform
efforts to protect the public while simultaneously making the
climate more favorable to putting new nuclear facilities on
line?
We have made several recommendations in the four meetings
that we had, beginning with July 1998, and the NRC has
responded to all of these in a very positive way, and I
compliment you for doing that excellent job.
Second--and when the chairman said that things move slowly
around this place, well, they move slowly in the NRC, too. It
is my understanding that it takes a very long period of time--
some say 5 years--to implement a change in NRC regulations.
Now, we want an open policy. We want a policy that includes
the public. But we have to make some changes. It's my
understanding if only one of many scientists dissent, then you
have to go through a whole new process that sometimes takes
years, and I think we can streamline that process.
Third, there is a discuss of what Congress can do to
increase the NRC's need for more resources. We are looking at,
as the chairman said, new facilities permits, and how we can
redistribute the existing resources before Congress starts
writing massive checks for a larger workforce.
Fourth, I'd like to get a better sense of how the fees
collected from the licensees are spent. It's my understanding
that only about 20 percent of these fees we can really document
exactly where they're going, and 80 percent are not adequately
accounted for. I think, Mr. Chairman, we are going to have to
do that before we make any major changes.
And, finally, I'd like to hear what other reforms must take
place in the future to protect the public, as well as maintain
and increase nuclear facilities as a key source of energy.
So if the NRC continues to properly implement safety-based
and other common-sense reforms, our nuclear industry will
continue to build on an already outstanding safety record, will
thrive in a more-efficient regulatory system, and, most
importantly, provide clean, reliable, and inexpensive source of
energy.
I think right now that the time is right. It wasn't right
before now, but I think now we've instigated some reforms. The
public is now awake and they realize that a very serious
problem is out there and you can't have a national policy
without having nuclear energy as a part of that.
I thank you, Mr. Chairman, for having this committee
meeting. I look forward to hearing our witnesses.
I might mention--I'm sure you are aware of it, but they may
not be here--we're going to have a series of stacked votes
starting at 10:15, so maybe before leaving we could dispose of
the first panel.
Senator Voinovich. That's a good suggestion. Thank you.
I think all of you are familiar with the procedure here
before this committee.
On our first panel today we have Richard Meserve, the
chairman of the Nuclear Regulatory Commission. Dr. Meserve will
be accompanied by Commissioners Diaz, Dicus, McGaffigan, and
Merrifield. For today's hearing, Chairman Meserve will provide
the testimony on behalf of the NRC, and if any of the other
commissioners would like to make a few brief remarks they may
do so.
Chairman Meserve, we'd like you, if possible, to limit your
remarks to the 5 minutes--you're familiar with the lights--so
that Senator Inhofe and I have a chance to get to some of the
questions that I'm sure are on everyone's mind.
We have the early bird rule here so that, as other Senators
come in, they'll be able to ask questions as they come in,
assuming any other Senators show up this morning.
Chairman Meserve.
STATEMENT OF RICHARD A. MESERVE, CHAIRMAN, NUCLEAR REGULATORY
COMMISSION; ACCOMPANIED BY: COMMISSIONER DIAZ, COMMISSIONER
DICUS, COMMISSIONER McGAFFIGAN, COMMISSIONER MERRIFIELD
Mr. Meserve. Thank you. Chairman Voinovich, Senator Inhofe,
I am pleased to appear before you today with my fellow
commissioners. I would like to take this opportunity to
acknowledge the strong support this subcommittee provided in
the 106th Congress in enacting legislation which addresses the
longstanding fairness-in-funding issue. We also appreciate the
subcommittee's and full committee's efforts in support of NRC's
other legislative proposals in the 106th Congress. We look
forward to working constructively with you in the new Congress.
I have submitted a statement for the record, but I would
like to make a brief summary.
As you know, the Commission does not have a promotional
role for nuclear power; rather, the agency seeks to ensure the
safe application of nuclear technology if society elects to
pursue the nuclear energy option. Many of the Commission's
initiatives over the past several years have sought to maintain
or enhance safety while simultaneously improving the efficiency
and effectiveness of our regulatory system.
We believe the Commission's most recent legislative
proposals, which are described in my statement, would enhance
safety and improve our regulatory system even further. I am
pleased to see that many of our proposals have been
incorporated into bills now pending before Congress.
The Commission also recognizes that its decisions and
actions as a regulator influence the public's perception of the
NRC and ultimately the public's perception of the safety of
nuclear technology. For this reason, the Commission's primary
goals also include increasing public confidence.
Currently, there are 104 nuclear power plants licensed by
the Commission to operate in the United States in 31 different
States. As a group, they are operating at high levels of safety
and reliability. These plants have produced approximately 20
percent of our Nation's electricity for the past several years.
In 2000, these nuclear power plants produced a record 755,000
gigawatt hours of electricity.
The Nation's nuclear electricity generators have worked
over the past 10 years to improve nuclear power plant
performance, reliability, and efficiency. The improved
performance since 1990 is equivalent to placing 23 new 1,000-
megawatt power plants on line. The Commission has focused on
ensuring that safety is not compromised as a result of these
industry efforts.
The nuclear industry is undergoing a period of remarkable
change. One of the more immediate results of the economic
deregulation of the electric power industry has been the
development of the market for nuclear power plants as capital
assets. As a result, the Commission has seen a significant
increase in the number of requests for approval of license
transfers. These requests have increased from an historical
average of about two or three per year to 20 to 25 in the past
2 years.
Another result of the new economic conditions is an
increasing interest in license renewal that would allow plants
to operate beyond the original 40-year term.
As the chairman indicated, the Commission has renewed
licenses for five units at two sites for an additional 20
years. The thorough reviews of these applications were
completed ahead of schedule. Applications for an additional
five units at three sites are currently under review.
As indicated by our licensees, many more applications for
renewal are anticipated in the coming years. The Commission
recognizes the importance of license renewal and is committed
to providing high-priority attention to this effort.
In recent years, the Commission has approved numerous
license amendments that permit licensees to make relatively
small power increases or uprates. Typically, these increases
have been approximately 2 to 7 percent. These uprates in the
aggregate resulted in adding approximately 2,000 megawatts to
the grid.
The NRC is now reviewing five license amendment requests
for larger power uprates. These requests are for boiling water
reactors and are for uprates of 15 to 20 percent.
While the staff has not received requests for additional
uprates beyond these five, some estimates indicate that as many
as 22 boiling water reactors may request such upgrades. These
upgrades, if allowed, could add approximately 3,000 to 4,500
megawatts.
In addition to the three already-certified advanced reactor
designs, there are new nuclear power plant technologies, such
as the pebble bed module reactor, which some believe can
provide enhanced safety, improved efficiency, lower costs, as
well as other benefits. To ensure that the Commission staff is
prepared to evaluate any applications to introduce these
advanced nuclear reactors, the Commission recently directed the
staff to assess the capabilities that would be necessary to
review an application for new construction. An examination of
possible changes in our rules is underway.
In order to confirm the safety of new reactor designs and
technology, the Commission believes that a strong nuclear
research program should be maintained. Additionally, the
Commission is reviewing its human capital to ensure that
appropriate professional staff is available.
The Commission's submitted statement highlights our nuclear
materials program. We have a very large number of materials-
related initiatives underway. Our submitted statement also
highlights other important programs such as the storage and
disposal of high-level waste and spent fuel, and provides a
summary of our fiscal year 2002 budget proposal.
The Commission has long been and will continue to be active
in concentrating its staff's efforts to meet our statutory
mandates. We are also mindful of the need to reduce unnecessary
burdens, to maintain open communications with all our
stakeholders, and to continue to encourage our staff to strive
for increased efficiency and effectiveness.
We look forward to working with the subcommittee and
welcome your comments and questions.
Thank you.
Senator Voinovich. Thank you, Chairman Meserve. That's an
excellent statement.
Do any of the other commissioners want to comment at all on
any of the subjects?
Ms. Dicus.
Ms. Dicus. Just let me say that I strongly support
everything the chairman has said. I think the whole Commission
does. There's nothing else I can say other than to support his
statements. Thank you.
Senator Voinovich. Any other comments?
Mr. Merrifield. Mr. Chairman.
Senator Voinovich. Yes.
Mr. Merrifield. I'll make just a brief comment.
Senator Voinovich. Yes, sir.
Mr. Merrifield. I do appreciate the opportunity to make a
comment to you and to Senator Inhofe. It is a pleasure to come
back to a committee of which I was a part of for approximately
10 years. In the 3 years that I have been involved with the
Commission, I think there is a significant change from where we
were, and I just want to underscore the chairman's remarks in
that respect.
Three years ago we were at a point where a substantial
number of plants were on the verge of shutting down or were
considering shutting down. What we've seen is quite a different
change, with a significant number of license renewals, license
transfers, and I think the Commission has made significant
progress with our new oversight process, which, indeed, I
believe, enhances safety of the reactors and our ability to
oversee them in the future.
That work was the work not of a single commissioner nor of
a single chairman, but the work of, I think, a dedicated and
collegial Commission, three of the members of whom were there
before I arrived.
One of the issues that is going to be raised today is the
issue of new plant orders. This is a matter that, frankly, we
had not considered very much when we were planning our fiscal
year 2002 budget some 18 months ago. At that point perhaps
Corbin McNeal of Exelon and maybe one or two others were
considering the notion of ordering new plants.
That notwithstanding, I think the Commission has the
flexibility in a disciplined and informed management process to
deal with the possibility. If we are confronted with new plant
orders, that's something that we're going to have to work
through.
I appreciate the kind words of the chairman and other
Members of the Senate in urging us to look at that issue
closely and volunteering additional assistance if necessary.
Mr. Chairman, I appreciate the chance to respond.
Senator Voinovich. Thank you.
On another committee, Oversight of Government Management
and Restructuring, where I'm subcommittee chairman, I spent 2
years looking at the human capital crisis that we have in the
Federal Government, and after talking with several members of
the Commission, you've got some real problems there.
There is a real desire, I think, on the part of Congress
and the American people to increase the productivity of the
already-existing nuclear power facilities that we have, and
Chairman Meserve has made reference to the fact that you've got
licenses pending before you, expect to have the relicensing,
and then there's genuine, I think, interest in the private
sector in building more facilities, and I'm for that.
But what concerns me is: are you going to have the human
capital necessary to do the job that you're supposed to do? And
we can talk all we want to about new ideas, new legislation,
streamlining, and so on, but what's the Commission doing about
preparing itself to be able to get the job done?
Mr. Meserve. Senator, we very much share your concern. I
know that you've been someone who has spearheaded the effort
here in the Congress to evaluate this issue, and it is one that
very much resonates with the Commission.
We are making an effort to do a systematic analysis of the
issue. We are performing an assessment of the areas of staff
competence, of the staff capabilities we need to have to do the
work that we anticipate that's going to arise, and then to go
through each of the gaps that exists and develop a program to
identify how we're going to fill those gaps.
There has been a major effort by our human resources group
for several months to get their arms around the nature of the
problem in specific terms.
The challenge is going to be great, because if, in fact,
there is new construction, we're going to be calling on skills
that the Commission has not had to exercise for many years--for
example, in being able to do inspection of construction. That's
not something that the Commission has had an opportunity to do
in recent years.
We have made some suggestions as to initiatives that would
help. For example, under the Federal Government's pension
system, a skilled staff person who is on retirement and comes
back to work at the Commission would find that every dollar
comes out of his pension. They end up with no additional funds.
So we have this problem with an aging staff. We've got some
very highly qualified people whom we would like to bring back.
Senator Voinovich. Is this a problem Government-wide, or
just specifically a problem that you have?
Mr. Meserve. This is a problem. I believe it's Government-
wide.
Senator Voinovich. OK. Any suggestions that you have that
would allow you to retain or bring back individuals that you
need, I'd like to have them as soon as possible, because we are
gathering those together for recommendations to the
Administration on things that we could do to get moving.
Mr. McGaffigan. Sir, there is a waiver authority in current
law that we are currently asking OPM for permission to
exercise--and I don't know whether we've heard from OPM yet--a
waiver authority that would allow us to perhaps bring back 30
people. So there's a limited waiver authority in current law
that we're trying to exercise. I think the chairman is
suggesting that perhaps even broader authority in that area
might be required.
Senator Voinovich. Well, it's interesting that OPM does
have--and that's the other thing that we're trying to
inventory, the flexibilities that OPM has right now that could
be utilized. I mean, the Army Corps of Engineers used to be
able to, for example, hire engineers on the spot. Somebody over
there decided 4 years ago we had a bunch of engineers out
there, so they stopped that. Now it takes them 6 months to hire
an engineer.
It is interesting to get the flexibilities they now have,
like with this waiver.
If you'd send me a note on that, I'll send them a letter
and tell them, ``Give them the waiver.'' It's what do you have
now to keep people, what do you need to bring some people back.
And the next issue is: what are you doing to get the word
around the country? They're closing down these engineering
schools in nuclear engineering. What are you doing to get them
to open them up?
Ms. Dicus. Mr. Chairman, could I make a comment about that.
I think my fellow commissioner would like to do that. You're
right. Several nuclear engineering schools have shut down, but
I was made aware--I think it's Texas A&M--I may be wrong on
that, but I think was Texas A&M, in their nuclear engineering
program they've almost doubled the number of students.
Senator Voinovich. Where is that again?
Ms. Dicus. I think it is Texas A&M.
Senator Inhofe. Phil Gramm's school.
[Laughter.]
Ms. Dicus. They've almost doubled in their freshman class
last year the number of students coming in, so I think, if we
deal with--and, of course, again, we cannot be promotional, and
we are not, but if the nuclear industry is getting stronger,
then I think that will help. But I think whatever you can do
here in Congress to support education in the area will be
helpful.
Senator Voinovich. I'd like to ask you, if you would, first
of all, confirm it's Aggies you're talking about.
Ms. Dicus. I'm not sure it is.
Senator Voinovich. Well, wherever it is, you read this
somewhere or someone has told you this, and if this is true
they have doubled I would like to know, not now, but for the
record. I'm glad they're doubling, but I wonder why, what the
reason was, because when a person was making a decision as to
what he or she was going to do for a career, the changes that
we're seeing right now had not been there, and so I'd like to
know that.
Ms. Dicus. I don't know the answer.
Senator Voinovich. For the record.
[The information follows:]
The university identified as having recently experienced a
doubling of enrollment in the nuclear engineering program was
confirmed to be Texas A&M University. Dr. Alan Waltar and
members of the faculty and staff of the Texas A&M nuclear
engineering department have prepared a paper, for presentation
at an upcoming American Society of Engineering Education
meeting, that provides details regarding the Texas A&M
enrollment figures as well as possible factors contributing to
the recent enrollment trend. The paper is attached.
------
Turning the Tide on Nuclear Engineering Undergraduate Enrollment (By
Alan E. Waltar, Marvin Adams, Ian Hamilton, Ron Hart, Lee Peddicord,
and Beth Earl, Texas A&M University)
The steep drop in undergraduate enrollments in nuclear engineering
since the early 1990s is a serious threat to nuclear engineering in the
United States and to the leadership that the United States has shown in
nuclear matters around the globe. Without a feedstock of fresh nuclear
engineers into the national nuclear infrastructure, America is on a
clear course of self-destructicn of an extremely valuable capability.
As a consequence, substantial efforts have been expended to
determine the causes for this precipitous drop (65 percent reduction in
students between 1993 and 1998). Senator Pete Domenici (R-New Mexico)
has sounded the alert from the U.S. Senate and Congressman Joe
Knollenberg (R-Michigan) is sounding a similar alert in the U.S. House.
A recent study by NEDHO (1) revealed that the gap between the number of
jobs available and the qualified applicants is large and growing
(projected to be about 3:1 in the next few years).
Given this backdrop, the recent rise in undergraduate nuclear
engineering enrollment at Texas A&M University has been quite
gratifying--our undergraduate enrollment having doubled from 1998 to
2000. Whereas this could be simply a spurious spike that cannot be
sustained, we felt an obligation to share some of the efforts that have
been employed to achieve this upward surge in the hopes that at least
some of these techniques might be employed elsewhere. It is important
that all strong nuclear engineering programs in the Nation experience
similar success if we are to produce the qualified manpower that our
country needs.
Listed below are the 8 steps that we at Texas A&M have employed
over the past two years.
1. Building the Case: In order for any product to sell, the basis
for sale must be solid. In the case of careers in nuclear engineering,
the case today is probably as strong (if not stronger) than it was in
the heydays of the 1960s and 1970s. The fundamental reason for this is
that the job market is growing and the student supply is low and
dropping. Students should be asked when to buy stock--with the obvious
answer ``Buy when the price is low!'' The recent NEDHO study (1) makes
it crystal clear that there currently exists a mismatch between demand
and supply, and this gap is increasing rather dramatically (up to about
a 3:1 ratio within the next few years). Further, nuclear power in the
United States is now very stable. The plants currently online are
highly valued on Wall Street and plant lifetime extension is likely to
keep most of them online so that today's graduates can look forward to
a full professional career at a single plant, should they choose to do
so. But even beyond this, new life within the DOE (such as the
Generation IV efforts) provides students with at least some hope that
new designs will receive serious attention. There are even
``rumblings'' of a new plant order within the United States in the
relatively near future--something unthinkable even 3 years ago. And, of
course, there are many careers outside of nuclear power for nuclear
engineering graduates. Opportunities abound with nuclear medicine,
agriculture, petroleum, general industry, law, and a whole host of
fields. In fact, only about \1/3\ of the nuclear engineering graduates
at Texas A&M go into the traditional nuclear power field. This degree
is a foundation for a rich host of opportunities in a wide variety of
fields. Hence, the basic case for attracting good students into the
profession is solid.
[NOTE: Step 2. was not supplied.]
3. Rallying Industry Support: Armed with the clear mismatch between
job opportunities and the number of students in the pipeline, our next
step was to contact major potential employers of our students within
the State of Texas and surrounding regions. Once they saw the problem,
many of the top executives agreed to participate in the formation of an
External Advisory Council to see how, collectively, we might be able to
reverse the downward spiral of entering freshmen. ln our case, we also
asked several well-known top industry and academic leaders from around
the Nation to join the Council, and we were fortunate to obtain an
affirmative response from all we invited.
4. Developing ``Headliner'' Scholarships: The first step of the
Council was to help our department develop a ``headliner'' scholarship
program, entitled the Stinson Scholars Program, named after the chair
of our Advisory Council, Ron Stinson (an early alumni from our program
and past president of the American Nuclear Society). These are $10,000
scholarships, payable at $2500 per year over 4 years for superior
students who remain in excellent academic standing within the program.
We requested industrial support for these scholarships and were
fortunate to obtain 4-year commitments from several corporations. We
issued 9 Stinson Scholarships to start the 1999 fall semester and were
able to increase the total to 14 to start the 2000 fall semester. This
has been so successful (in attracting both quantity and quality of
students) that our faculty sponsored 2 of these Stinson Scholarships
this year from personal funds!
5. Promoting Other Scholarships: We, like several other programs,
have been the fortunate recipient of the new DOE matching program,
which has allowed us to both upgrade computer facilities and offer
additional scholarships. Using the Stinson Scholarship program as our
major advertising leader, we have been able to get students to apply
for a variety of scholarships, including those offered by DOE, ANS,
NANT, plus other department scholarships (some of which are endowed).
The overall push for scholarships allowed our undergraduates to go from
a total of 5 scholarships in 1998 to 33 in 1999 and 54 in 2000 (with
respective yearly monetary totals going up from $5,000 to $52,500 to
$100,000 in these respective years).
6. Publicizing Starting Salaries: The College of Engineering at
Texas A&M University is one of the largest (if not the largest) in the
Nation. It totals around 9500 students. The Department of Nuclear
Engineering is the smallest department within the College (likely the
case throughout the Nation), yet our seniors received the highest
starting salaries in the entire college in 1998--plus signing bonuses
in many cases! This position was maintained in 2000. Hence, we are able
to tell prespective students that we have excellent scholarships and
that they will be very well rewarded when they finish the program. This
is a powerful message!
[NOTE: Step 7. was not supplied.]
8. Recruiting New Students: Armed with the above messages, our
first direct recruiting step was to design and publish a new
undergraduate recruiting brochure. This rather unorthodox brochure
(clearly designed for the ``now'' generation!) contains the essence of
the above messages, plus testimonials from some of our most successful
graduates. Our first batch of brochures, along with a recruiting
letter, went to some 200 high schools--those where some previous
contact had been made. Buoyed by a highly successful ``Women in
Discovery'' Program (2), which featured the legacy of Marie Curie, the
list of schools currently being contacted has been extended to
approximately 650. For those high school students accepted into our
program, faculty and students within our current program placed
telephone calls. This was done in recognition that many of the best
students are accepted into several programs, and we wanted to maximize
the ``catch'' rate. In addition, a special letter was sent to these
students by a CEO at a nearby nuclear utility--congratulating them on
their choice of major and offering a summer job to all students in good
standing at the conclusion of their freshman year! Some actual
recruiting visits were made to high schools, but that has been minimal
to date. We hope to substantially increase this in the near future.
Teacher workshops continue to be very helpful, because once teachers
are aware of the incredible opportunities in nuclear engineering, they
are far more likely to pass that enthusiasm on to their students.
Having conducted one successful workshop last year, we have already
completed another one this year and hope to do several more. Our
faculty members have also given several talks and workshops on campus
for high school students visiting for other campus-wide events.
9. Recruiting On-Campus Students: Freshmen admitted to the College
of Engineering at Texas A&M are required to declare a major upon
arrival. However, the curricula for freshmen are essentially the same
for all majors. The College has two ``Open House'' nights each year
(one each in the fall and spring semesters), in which students are
required to attend two departmental presentations. They generally
attend the presentation given by the department of their declared
major, but they must attend one other session. We push hard for them to
select the nuclear engineering presentation as their other choice, and
we provide information condensed from the above material (items 1
through 5) by faculty and students. Our most persuasive speakers are
our top students, who carry unbridled enthusiasm for our program.
10. Emphasizing Retention: Perhaps our best recruiting tool is the
way we try to treat students once they are accepted into the program.
For example, this year our student leaders went the ``extra mile'' by
personally greeting all new students as they came for campus
orientation. In addition to making them feel welcome, they invited them
to a ``get acquainted'' party sponsored by the Department shortly after
the opening of classes. We were especially fortunate this year to have
ANS President Jim Lake in town in early September, so we built the
party around him. Approximately 100 students came to the barbecue. This
occasion provided a particularly good opportunity for recognizing the
scholarship winners. We also inaugurated a mentoring program, whereby
new students mix with upperclassmen and graduate students (a range from
freshmen to Ph.D. students)--along with one or two faculty members--for
free pizza approximately every two to three weeks. There is no set
agenda, but the personal interactions and networking that naturally
transpire seem to be very meaningful to students at all stages of their
careers. Also, we strongly support student professional groups.
Students participating in student activities are rewarded by department
sponsorship of travel to national and international professional
society meetings. For example, 26 students within the department were
sent to France in the fall of 1999 to a conference in Paris sponsored
by the French Nuclear Student Section. An average of about two dozen
students are sent to national ANS and HPS meetings each year. Also, 6
students were sent to Russia as part of a NATO conference this past
summer. Other students have been able to attend meetings in Japan and
Belgium. This type of support is highly appreciated by the students,
and they readily share such experiences with students in other
departments. We believe this type of attention and support is
responsible for both a highly motivated student population and a major
reason we attract several students each year who decide to transfer in
from other departments.
Whereas it is difficult to ascertain which of the above approaches
is most influential in our recruiting process, we tend to believe that
the hot job market (high paying jobs) and large scholarships are the
primary ingredients for the rapid increase in undergraduate enrollment.
As shown in figure 1, our undergraduate enrollment plummeted to a low
of 55 in 1998 (mirroring the national trends), but has subsequently
climbed to 109 in the fall of 2000 (a doubling in 2 years). We fully
recognize that this trend may not be sustainable. It is still a very
difficult job to attract good students into a profession that has
received such bad press within the past decade. But we are gratified by
the rebound recently experienced and hope that at least some of the
efforts we have employed might be equally successful elsewhere.
[GRAPHIC] [TIFF OMITTED] 78072.001
Mr. Diaz. If I may, just add a comment. Since I came from a
nuclear engineering school and I just visited there, I think
there is now a different environment. I went to the University
of Florida and met with the students 3 weeks ago, and, you
know, there was a different feeling. I think they think that
there is now the potential for them to contribute to our
society, and before it was almost like a black cloud that, you
know, was almost like a stigma. And I think the students feel
that there is a new opportunity and that this will bring
renewed interest in the career.
But one point, Senator, that I know very well is that the
nuclear engineering students are now the highest-paid of all
outcoming bachelors in the United States. The entry salary for
nuclear engineers is $57,000 because there are so few of them.
And so they are--the ones that are in there are actually
receiving significant benefits.
And I might offer a personal comment to Senator Voinovich.
Senator, I'd be willing to make my own personal contribution to
the issue of human resources and postpone my retirement.
[Laughter.]
Senator Inhofe. Mr. Chairman.
Senator Voinovich. Go ahead.
Mr. McGaffigan. Sir, just on the university issue, I'd just
add one more data point.
Cornell, MIT, and Michigan are thinking about shutting down
their research reactors. Mr. Magwood from the Department of
Energy testified, I believe, to the Senate Appropriations
Committee last week to that effect and was looking for
emergency funds in order to--and I think Senator Domenici is
going to be supportive--to keep those research reactors alive.
I think there is a delay. I think Senator Inhofe is right.
If I were counseling a young person, I would counsel them to go
into nuclear engineering today. They'll be at the leading edge
of, I think, a rebirth of this industry. But that's not what
the academic deans at some of these universities think. They
see unused research reactors, they see small nuclear
engineering departments, and, unfortunately, there has been a
trend in recent years to shut them down. It is primarily the
Department of Energy's job. They're the agency that funds
research in universities, and they are on top of it and, I
think, trying to do something about it.
Mr. Merrifield. If I may just layer on top of that--not to
take your time--two things. First, I agree with Commissioner
McGaffigan. The value of the research reactors is paramount.
For our agency, the largest recipient of our research funding
from the university standpoint is the University of Michigan.
If that reactor were to close, there are a number of programs
that we have in the research sector which would be endangered.
We would have to find some place else to take those. So for us
that reactor is quite important.
Second thing, I agree with him in terms of the lag time
with the management structure within the engineering schools. I
had an opportunity to visit the University of Maryland to do
some recruiting this year. I found students who were very
excited. I found professors who were very excited about what
was going on. And I found an engineering school dean who was
very doubtful of the future of nuclear power and who was very
much considering the notion of whether they ought to keep their
reactor and their undergraduate program. So there is a
disconnect and there is a time lag which is of concern.
Senator Voinovich. I'll tell you what I--I'd just like to
finish up--what I'd like to do would be for somebody in your
shop to identify the schools that are active, the reactors that
are out there, and maybe Senator Inhofe and maybe some of the
other members of the committee might be willing to send letters
out to the schools indicating to them that it appears that we
know we need more people in that area.
I was with Governor Engler the other day and the former
president of the University of Michigan, a nuclear engineer
named Dudersdoff. We talked to them about revisiting that
issue, and even with the reactors to just have a little plan in
place where we can highlight the need and just kind of give
them a heads-up, and then if there is some additional Federal
money that we need to have to keep things on the road, that we
ought to do that. But we need a strategic plan put together to
deal with the human capital crisis, and, frankly, I'd like to
have your best thoughts about how, in your opinion, you can
deal with the current problem, bring more people back, and what
other tools do you need to attract people into your agency.
Mr. Meserve. We'd be happy to submit something, Senator. We
would very much welcome that.
Senator Voinovich. OK.
[The information referred to follows:]
The following is a list of schools which have research
reactors with an active operating license. The University of
Illinois has an operating license but has ceased operations.
The first three schools listed have publicly announced their
intention to shut down their research reactors in the near
future. Please note that the NRC has not received formal
correspondence concerning a shutdown of any of the listed
facilities: Cornell University TRIGA; Massachusetts Institute
of Technology; University of Michigan; Idaho State University;
Kansas State University; North Carolina State University; Ohio
State University; Oregon State University; Pennsylvania State
University; Purdue University; Reed College; Rensselaer
Polytechnic Institute; Rhode Island Atomic Energy Commission;
Texas A&M University; University of Arizona; University of
California at Irvine; University of Florida; University of
Maryland; University of Massachusetts--Lowell; University of
Missouri--Columbia; University of Missouri--Rolla; University
of New Mexico; University of Texas; University of Utah;
University of Wisconsin; Washington State University; Worcester
Polytechnic Institute; University of California--Davis,
McClellan.
Senator Voinovich. Senator Reid has come in, ranking member
of the main committee. Senator Reid, would you like to make
some comments before Senator Inhofe asks his questions?
Senator Reid. Senator Voinovich, I apologize to everyone
for being late. I went to our old office place and then
somebody sent me to the Russell Building, and I've been running
around for about 25 minutes trying to find this, so it's not
anyone's fault except my staff, and I apologize for that.
Being late, I feel very discourteous reading a statement. I
have some very serious questions. I will ask permission of the
Chair to submit my statement as if read.
[The prepared statement of Senator Reid follows:]
Statement of Hon. Harry Reid, U.S. Senator from the
State of Nevada
Mr. Chairman, I want to thank you for calling this hearing today to
allow us to discuss oversight over the nuclear power industry.
Today we are going to hear from industry and advocacy groups about
the issues with the NRC and about plans for new nuclear power plants.
I can't imagine having this discussion without raising the specter
of dealing with the pollution produced by the industry. This is
pollution that we must monitor not for 10, not for 100, but for more
than 100,000 years.
As you all know, the State of Nevada has been chosen as the only
site studied in the Nation for a proposed underground nuclear waste
storage facility.
But perhaps you didn't know that Yucca Mountain is only 90 miles
from Las Vegas, Nevada's largest and one of America's fastest growing
cities. In addition to being home to more than 1.3 million Nevadans,
Las Vegas and its neighboring communities draw more than 30 million
visitors each year.
The Department of Energy is in the process of scientific studies
into Yucca Mountain. I am aware that there is tremendous pressure being
applied by the nuclear industry to make the science fit the site.
But, Yucca Mountain just is not the right answer.
What does all this have to do with today's hearing? The answer is
simple: before we consider rushing forward to build new nuclear power
plants we need to address the nuclear waste question in a meaningful
way.
Not doing so would be like Henry Ford designing and building every
part of the Model T except the exhaust. No one would consider mass
producing such a defective car.
We can choose to invest in the truly sustainable generating sources
such as wind, solar, geothermal, efficiency and conservation:
Well-sited wind farms generate energy at rates of less than 5 cents
per kilowatt-hour and will soon get to 3 cents per kilowatt-hour.
That's competitive with the cheapest fossil fuels and nuclear power--
without the harmful pollution.
A 10,000 square mile region of Nevada could supply our Nation's
entire electricity needs with existing solar technology. With the right
investments this technology will only improve.
Energy efficiency continues to save energy at less than a few cents
per kilowatt-hour.
We can choose to end the tremendous Government subsidies of the
nuclear power industry:
Nuclear power generation is a mature industry that has outgrown the
billion-dollar-a-year Price-Anderson subsidy. We should allow the
market to decide if spending $2000-$3000 for every kilowatt of nuclear
power is the right kind of investment to make.
I don't think the market will be willing to take that kind of
financial risk.
Finally, I would like to raise some specific issues with the
Nuclear Regulatory Commission.
First, I am concerned by the pressure the Nuclear Regulatory
Commission continues to place on the Environmental Protection Agency
(EPA) over the Yucca Mountain radiation standard.
According to the 1992 Energy Policy Act, the EPA has the legal
responsibility to set this standard.
In October of last year, Vice President Cheney visited Reno, NV and
assured the residents of my home State that the EPA would be the lead
agency on this standard. They also indicated that they would support a
rigorous standard from the EPA which would fully protect families in
Nevada.
The residents of Nevada deserve to have vital groundwater resources
that are as safe as anywhere else in the country.
Second, I have concerns about the recent efforts to eliminate
restrictions on foreign ownership of nuclear plants. We don't allow
foreign control of airplane manufacturers, why should we allow foreign
control of our nuclear power industry?
Today, nuclear power plants are bought and sold like used cars.
We already have several 50-50 partnerships between United States
and foreign firms, and Westinghouse--a major supplier of maintenance,
parts and services for the industry--is now a wholly-owned subsidiary
of British Nuclear Fuels, Ltd.
This Administration talks about the need to decrease foreign
control of our domestic energy market. We should start by ensuring
domestic ownership of the nuclear power industry.
Third, I am concerned with the erosion of public participation in
the licensing of new plants and the relicensing of existing ones.
The NRC has chosen to keep the formal hearing process for the
licensing proceedings related to Yucca Mountain. But where is this same
protection for licensing and relicensing?
If the industry truly has a safe, efficient, and reliable product
they should not be concerned with holding formal hearings to discuss
the extension of the licenses.
It is time to bring some rational thought to the debate over
nuclear power.
No longer should we discuss the virtues of nuclear power without
addressing the vices of nuclear pollution.
No longer should we use Government subsidy to prevent the
extinction of this dinosaur of an industry.
We have an obligation to our children to ensure that our short-term
energy needs are not met with long-term environmental neglect.
I look forward to hearing from our witnesses today on these
important issues.
Senator Reid. I do have some questions that I would ask be
returned to me and the committee within 2 weeks. As everyone
knows, it is a very serious issue for me. Some say the
difference between nuclear waste in Nevada and not is a fair
treatment by the NRC, so I would ask respectfully that my
questions be answered at the earliest possible time.
Senator Voinovich. Thank you.
Senator Inhofe.
Senator Inhofe. Well, yes, let me get into something else,
and that is I perceive a problem, and that is in our radiation
policy it is somewhat duplicative, at least with the EPA. It
has been my opinion that the EPA's regulation portion of this
is based more on policy than on science.
I'd like to hear from any of the commissioners how you feel
this can be corrected. Do we have a duplication of regulation
that is unnecessary at this time?
Mr. Meserve. Well, I know that Senator Reid is going to ask
some questions dealing particularly with Yucca Mountain. Let me
answer the question in terms of a more general issue--namely,
the decommissioning of nuclear sites.
There is a duplication of effort that arises from the fact
that, for our licensees, we have an obligation under the Atomic
Energy Act to supervise those licenses and make sure that the
facilities are decommissioned properly.
EPA has overlapping jurisdiction with us as a result of
CERCLA, the Superfund Act, and that has resulted in at least
some disagreements that have arisen from time to time in that
our standards for decommissioning are defined by rule, and they
specify certain limits that we anticipate our licensees are to
meet.
EPA has not proceeded by rule, but does have a policy
where, for the cleanup of Superfund sites, it would require
cleanup to a different limit. That has created confusion with
our licensees. They fear that they might clean up to satisfy
our standard and then be left with an obligation under
Superfund, after they have satisfied our requirements, where
the EPA might come in and demand additional requirements of
them.
We believe that the EPA standards are unnecessary and do
not have an adequate scientific foundation.
Senator Inhofe. I see. Any other comments on that?
Mr. McGaffigan. Mr. Chairman, I just might add on this
point about rulemaking, we went through a very, very complex
rulemaking to establish our decommissioning standard back in
1997. It was unanimously supported by the Commission. We did
look at what EPA was proposing. That was something, indeed,
that we had put in our proposed rule to get comments on, and
when we did calculations to look at what it would take to get
to the EPA standard, we found either negative health benefits
or cost per life saved that ran into the tens of billions of
dollars, and we could not justify going to the EPA limit. For
instance, their strontium-90 maximum contaminant level is 6/
100ths of a millirem per year. That's 3 hours in the Senate
waiting room if you want to translate it into your own life.
That's just a very, very problematic standard.
[Laughter.]
We actually did cost/benefit analysis, and we just could
not justify EPA's proposed standard. There are voluminous
documents we would be happy to share with your staff that
documented why we ended up where we did in our rule.
Senator Inhofe. But, Commissioner, what I have heard on
this is that they are regulating to 1/10th or 1/15th of what is
considered now to be safe. Is that information fairly accurate?
Mr. McGaffigan. Sir, they sometimes regulate----
Ms. Dicus. Less than that.
Mr. McGaffigan. With the strontium-90 at the 6/100ths of a
millirem per year level, they are regulating to 1/10,000th of
background radiation.
Senator Inhofe. And the cost of regulation when you get to
those levels is far greater than initial costs?
Mr. McGaffigan. It makes no sense to regulate at those
levels, in my opinion, sir.
Senator Inhofe. One other question. The recommendation you
made under Price-Andersen renewal, it was made at a time, it's
my understanding, that you felt there would be about 50 percent
of the number of plants that there now appears that there will
be out there, and so I assume, when you're talking about
increasing from $10 million to $20 million is because you'd
only have half as many plants paying that premium, and now that
all of them--it appears to be twice that many. What is your
current opinion and recommendation?
Mr. Meserve. You're quite correct. There was a report we
submitted in 1998 that proposed the retrospective premium be
changed from $10 million per reactor to $20 million per reactor
per year, and that was based, exactly as you said, on the
assumption that was then the current view that there would be a
decline in the number of nuclear plants. That is unlikely to be
occurring because of license renewal. So the Commission has
revisited that recommendation, and we now no longer recommend
that an adjustment in the retrospective premium be made. And we
will be happy to submit a letter for the record to that effect.
Senator Inhofe. Yes. I would like to see it. I had not seen
anything as far as a change of your recommendations, so we'd
like to have that.
Mr. Meserve. We have recently been conferring on that
issue.
Senator Inhofe. Regarding Price-Anderson, provide NRC's
change of position on the maximum annual retrospective premiums
based on the new situation for license renewals ($10 million
vs. $20 million as in 1998 report) in a letter to the
subcommittee and to me. Please provide information this week or
early next week.
[The letter provided to the subcommittee and Senator Inhofe
follows:]
[GRAPHIC] [TIFF OMITTED] 78072.014
[GRAPHIC] [TIFF OMITTED] 78072.015
Senator Inhofe. Let me clarify it for Commissioner Dicus.
When I said ``for the record,'' I meant in writing when you
find out, not for the record today.
Thank you, Mr. Chairman.
Senator Voinovich. Senator Reid.
Senator Reid. Mr. Chairman, thank you.
During the presidential campaign, Dr. Meserve, President
Bush and Vice President Cheney clearly stated in Nevada that
the EPA should be the lead agency in developing the standard.
Do you agree with the President that EPA should be the lead
agency?
Mr. Meserve. I think this is, in fact, an issue for the
Congress to decide and not for any particular agency. The
statute provides that EPA is to have authority to set the
standards, and when and if EPA does that, then we will conform
our requirements to them.
We have had a dispute with EPA as to the standards, as you
are aware, and I have suggested, the Commission has suggested
that one way to resolve that would be to put the NRC in charge,
not to have two different agencies that have overlapping
responsibility. But we are going to comply with the law.
Senator Reid. Well, that's kind of like what just took
place in the Senate. If you don't like the rules, you fire the
umpire. We just had our parliamentarian fired. That's kind of
what I see you are doing here. You don't like the rules, so you
want to change them, and you've already indicated that EPA
should the lead agency, right?
Mr. Meserve. I indicated the statute provides that EPA is
to have the authority to set the standards. There is no rule,
in fact, that is in place at the moment. As you know, the EPA
has a final rule that is in a concurrence process now.
Senator Reid. That's the issue. The EPA would have issued
the standard a long time ago but for the pressure of your
entity and others from the nuclear power industry trying to
force them not to have the rule that they feel is the right
one. You're aware of that, aren't you?
Mr. Meserve. Well, I am aware that we have had
disagreements with EPA on a matter of principle. We're not
engaging with EPA on behalf of the nuclear industry. We believe
that those standards should have an appropriate form. We are
supported in that by the National Academy of Sciences. We are
supported by the way international organizations regulate these
materials. So we are trying to push for an appropriate rule as
we see it.
Senator Reid. How much money has the NRC spent since 1992
to develop independent radiation release standards for the
Yucca Mountain Nuclear Waste Repository? Do you know?
Mr. Meserve. I don't know, Senator. I'd be happy to find
that information and submit it for the record.
Senator Reid. OK. Do you know how much staff resources have
been dedicated to that task?
Mr. Meserve. I don't know, but, again, there has been a
substantial amount of staff effort that has been underway for
several years because of the role that Congress defined for NRC
with regard to Yucca Mountain. I will have to submit for the
record the details.
Senator Reid. We would appreciate your doing that. How much
money and staff resources has the NRC spent since 1992 to
develop its independent high-level waste repository ratiation
standard for Yucca Mountain?
[The information requested follows:]
It is our understanding (based on the testimony transcript and
discussion with you staff) that the question relates only to the
development of ``independent radiation release standards'' or dose
limits. The staff estimates that approximately 2 to 4 staff weeks and
$10,000 in contractor expenses were incurred in specifying the proposed
radiation standard and responding to public comments regarding the
radiation standard. This expenditure is small because it reflects only
those costs associated with NRC's specification of an annual,
individual, all-pathway dose limit of 0.25 MSv (25 mrem) and not the
costs associated with development of other aspects of the NRC's
regulations.
The Energy Policy Act of 1992 specified the development of a Yucca
Mountain-specific repository standard that would be based upon and
consistent with the findings of the National Academy of Sciences (NAS).
The NAS released their report on the technical basis for a Yucca
Mountain standard in August 1995.
The NRC specified a dose limit in its proposed regulation for Yucca
Mountain that is generally consistent with the NAS report,
recommendations of the International Commission on Radiation
Protection, and NRC's dose limits for decommissioning of nuclear
facilities and low-level waste disposal [i.e., annual, individual, all-
pathway dose limit of 0.25 mSv (25 mrem)]. Because the dose limit was
already in use in NRC regulations, limited effort was necessary for its
specification in proposed 10 CFR Part 63.
Under its authority, NRC is responsible not only for implementing
the EPA standard, but also for specifying other criteria for ensuring
safety of the Yucca Mountain repository (e.g., performance assessment,
performance confirmation, emergency planning, and quality assurance).
The total NRC resources that have been spent since release of the NAS
report to develop the NRC regulations are approximately $800,000
(including NRC staff and NRC contractor costs associated with the
Center for Nuclear Waste Regulatory Analyses.) The staff resources
reported are for work directly related to developing the regulation.
Senator Reid. Also, Doctor, isn't NRC's responsibility to
license a site once DOE submits an application?
Mr. Meserve. Yes, we do that. We do other things, as well.
We set standards, we would have an obligation to supervise the
construction of the site and the operation of the site and the
closure of the site. It goes beyond just simply the licensing.
Senator Reid. That would be 10,000 years from now closing
the site?
Mr. Meserve. Pardon me?
Senator Reid. That's 10,000 years from now in closing the
site?
Mr. Meserve. Well, the closure is the closure after the
waste has been in place, and then after some period of
monitoring. I believe it has been NRC's--excuse me, DOE's
intention to do what they call ``close a site,'' which is to
seal it, and there would be no further necessary DOE
involvement at the site in terms of penetration into the area
where the waste is stored.
Senator Reid. Have they told you how long it would take to
fill that?
Mr. Meserve. Pardon me? How long it would take to fill it?
No, I don't know that.
Mr. McGaffigan. Sir, I think the----
Senator Reid. Why does the Commission believe it has any
role in setting environmental standards for the site?
Mr. Meserve. Well, as part of the licensing process, we are
subject to NEPA process, and so we do have an environmental
role that is imposed on us by NEPA. The statute provides that
we are to rely on a DOE environmental impact statement to the
extent we can.
Senator Reid. Somebody--did I hear somebody trying to say
something?
Mr. McGaffigan. Sir, I've lost the train of thought. We
have a role to write implementing regulations.
Senator Reid. Better than never having had a train of
thought.
[Laughter.]
Mr. McGaffigan. We have a role in implementing regulations
to the EPA standard.
Senator Reid. Say that again now.
Mr. McGaffigan. We write our rules that go into more detail
than the EPA umbrella standard, and that process has been
underway for some time. As you know, early in that process,
because EPA had not yet established an overall standard, we
proposed a standard back a couple of years ago. But, as the
chairman has said, consistent with the statute, once EPA did
issue its proposed rule our intention now is to wait for their
final rule and conform to it.
But there is a regulatory role that we have, in addition to
the licensing role, that is established by statute.
Senator Reid. So you don't think the President or Vice
President said anything that was improper saying that EPA
should be the lead agency in developing the standard?
Mr. McGaffigan. That's law, sir.
Senator Reid. So I guess my last question is: then why is
it appropriate that you are trying to get them to change the
standard before it is issued?
Mr. McGaffigan. Sir, we are a commenting entity, as the
National Academy of Sciences and other people are, and it is
appropriate for us to make comments about the EPA rule as we
did publicly, and our comments on the EPA rule are a matter of
public record, just as EPA comments on our rule are a matter of
public record.
Mr. Meserve. Just as you, Senator, have a right to submit
comments to EPA, we do, as well.
Ms. Dicus. And, if I could support the comments that we
have made by this Agency to the EPA, it is our right to do
that, and we have done that.
Now, we understand they have a statutory authority to set
the standards, but we can also make comments on that standard.
Senator Voinovich. We have a vote scheduled, and I haven't
any further questions except one general one, and, Dr. Meserve,
you've kind of handled it, but it gets back to a conversation
we had some time ago, and that is I really am interested in
your best thoughts--and share this with your fellow
commissioners--the issue of if we wanted to jump-start the
productivity of already-existing facilities and create an
environment where it would be easier for new facilities to be
built, from your perspective what things would be necessary in
order to get that done?
And, again, the issue of the human capital issue is also
one that I'd like to hear from you, not so much for this
committee but for the other committee that I chair in terms of
the crisis that we're facing. I'd love to use your agency as an
example of how this human capital crisis is impacting upon our
Federal Government. That would be very helpful to me.
Mr. Meserve. We would very much welcome the opportunity to
assist you.
Senator Voinovich. We would like recommendations to help
the human capital problems. What is working at the NRC? What do
you have in place to keep people (staff)? What are we doing to
bring people back and to attract new hires?
[The information referred to follows:]
The staff is developing a comprehensive plan for implementing a
systematic strategic workforce planning process at NRC to address core
competency issues. This plan will address workforce planning issues,
such as an aging workforce, potential lack of critical skills,
succession planning, and the effect of external labor market trends on
the availability of needed skills.
NRC has put in place a number of promising strategies to retain the
attract employees. These strategies include:
<bullet> LHire employees prior to the departure of experienced,
technical staff to facilitate knowledge transfer
<bullet> LIncrease compensation/number of higher level positions
<bullet> LIncrease permanent entry level interns and cooperative
education students
<bullet> LProvide grants for college students
<bullet> LImplement student loan repayment programs
<bullet> LImplement fellowship programs for employees to develop
skills unique to NRC
<bullet> LGrant Waivers of Dual Compensation Limitations where
appropriate
<bullet> LContinue to use recruitment bonuses
<bullet> LContinue training and retraining efforts
The agency will continue to use these strategies to retain critical
technical skills. We will continue to provide robust training
opportunities, flexible work schedules, high quality working
conditions, a family-friendly work environment, and employee services
(e.g., up-to-date information technology tools, onsite daycare, health
and fitness programs.) The NRC has expanded its outreach activities,
established competitive entry-level salaries, and will use recruitment
bonuses, and establish fellowship programs. Through the use of these
strategies, NRC seeks to address the human capital challenge
effectively.
Senator Voinovich. Thank you. I thank the panel very much
and we'll be back----
Senator Inhofe. Let me ask one thing for the record here.
Senator Voinovich. Sure.
Senator Inhofe. In my opening statement I commented that I
had heard that 80 percent of the fees that had been collected
from licensees don't have adequate accounting. I'd like to kind
of get some kind of a feel from you in writing for the record
on that, and what can be done to change that. Please respond to
the adequacy of accounting for the money we collect from fees--
as well as money from the waste fund, general fund, and so
forth. Also, explain what percentage is from Part 170, Part
171, waste fund, and general fund.
[The information referred to follows:]
Approximately 7 percent of the NRC's fiscal year 2001 budget is
appropriated from the Nuclear Waste Fund and the General Fund. The
remaining 93 percent of the budget is offset through fees charged to
NRC licensees.
The assessment of Part 170 and Part 171 fees is non-discretionary
and in compliance with statute and case law. The agency collects
approximately 25 percent of its required fee amounts from Part 10 fees
for specific services. These fees recover the NRC's costs of providing
specific benefits to identifiable applicants and licensees. Examples of
the services provided include review of applications for new licenses,
the review of applications for renewal of existing licenses, the review
of requests for license amendments and inspections. The remainder of
the fees are collected through Part 171 fees (annual fees) to recover
generic and other regulatory costs not otherwise recovered through Part
170 fees. These annual fees recover the agency's budget associated with
activities such as: allegations; contested hearings; research;
development of risk-informed regulations; rule development; maintaining
the incident response center; international programs; oversight of
Agreement States; and issuance of orders. NRC's basis for calculating
fees are discussed in our annual proposed fee rule and are subject to
public review and comment.
The agency complies with the appropriate laws, regulations and
generally accepted accounting principles for its accounting operations,
including receivables such as fee collections. The NRC's financial
records are audited annually by the NRC Inspector General. The NRC has
received an unqualified financial statement audit opinion each year
since fiscal year 1994.
Mr. McGaffigan. Sir, could I just comment on that? About 80
or 79 percent comes from annual fees, and the other 21 percent
comes from fees that we attribute to a particular licensing
action or particular inspection. That doesn't mean the 80
percent aren't accounted for. It means that they are used for
things like research, paying the rent on the building, and the
Commission developing rules. There's no issue of waste in that
80 percent. It's largely an accounting device.
We have--for reasons of policy, over time made decisions,
for instance, to have lower fees for small businesses, to not
charge fees to universities, to not charge first-of-a-kind
fees, for instance, or to pro-rate when somebody is the first
license renewal--such as Calvert Cliffs. We didn't charge them
the full fees because we were learning how to do license
renewal, so we had a discount for them.
There's a lot of that that goes on. The pebble bed
reactor--if there's going to be research related to that
reactor, that research would be charged to all reactor
licensees, not to Exelon because it's a first. We believe the
benefits accrue to the whole industry.
So the 20 percent versus 80 percent is largely an
accounting artifice rather than an issue of indicating that
there's any waste. We don't believe there is.
Senator Inhofe. Perhaps that's true then.
Ms. Dicus. Absolutely.
Senator Inhofe. And perhaps I didn't get the right
information concerning that. So if the other 80 percent is
properly accounted for, then just let us know this.
Mr. McGaffigan. Sure. Yes, sir.
Senator Reid. Chairman Voinovich, if I could just say one
last thing--because my time was up--my concern, Dr. Meserve and
other members of the Commission, is that you're doing more than
submitting comments. I don't think that you should be involved
in inter-agency review process and other things that are simply
more than my commenting on a rule, and I think you're going way
beyond commenting on a rule, and I don't think it is
appropriate.
Senator Voinovich. Thank you, Senator.
I have one--and I'm going to ask you to submit it. I just
received a letter from a constituent, very important, Dr.
Silverstein, who is at the Department of Nuclear Medicine at
University Hospital in Cincinnati. He basically states that,
``The amendments to the 10 CFR part 35 are before OMB for
review. In my opinion, the proposed NRC regs add to the cost of
health care without improving patient safety.'' And he goes on
to talk about some of the other things that he's concerned
about.
He also mentions that he feels that the Commission ignored
the advice of the National Academy of Science Institute of
Medicine. It's a pretty specific question, and I'll have it
submitted to you and I'd like to have a written explanation and
response to Dr. Silverstein's letter to me.
Mr. Meserve. We'd be glad to do that, Senator.
Senator Reid. Senator Voinovich, would you indicate to the
members of the panel here today what we're going to do? We
should have a vote. I don't know if it's----
Senator Voinovich. Yes. We're going to go vote, and we've
got another one or two and we'll come back and convene the
hearing and hear from our other witnesses.
Senator Inhofe. I understand, Mr. Chairman, that we have
three votes, and if we can get a tail wind with this one we
could get back probably by close to 11:00.
Senator Reid. You're kidding? Not a chance.
Senator Inhofe. That gives them 10 minutes more than it
says it's going to take. Let's just say--you're in the
leadership.
Senator Reid. That's why I laughed.
Senator Voinovich. Well, we will try.
Senator Inhofe. One last thing. I was talking to my staff
about this 80 percent, and I still would like to get this down
to show the accounting where it is.
Mr. Meserve. Sir, we'd be glad to do it.
Ms. Dicus. We'll do that.
Senator Reid. Thank you, Mr. Chairman.
Senator Voinovich. OK. What we're going to do is that--yes,
we'll be in recess for 30 minutes and come back. Again, I
apologize to the witnesses that are here, other witnesses that
we have to testify today, but if you know anything about the
Senate, we just do the best we can.
Senator Reid. This panel may be excused then?
Senator Voinovich. Yes, it is. Yes. Thank you very much.
You will be getting some other written questions from members
of this committee, and we're going to leave the record open for
2 weeks. Thank you.
Mr. Meserve. Thank you.
Senator Voinovich. Thank you very much.
[Recess.]
Senator Voinovich. The committee hearing will come back in
session. I apologize to those testifying today. Senator Reid
reminded me he said it would be 11:00 and he was right. We are
hopefully going to get some rules to say if it is a 10-minute
vote it's a 10-minute vote, and if you're not there you miss
voting. Again, I appreciate your all being here.
Our next panel will be: Mr. Joe Colvin, president and CEO
of the Nuclear Energy Institute. Following Mr. Colvin will be
Mr. David Lochbaum, nuclear safety engineer at the Union of
Concerned Scientists; Mr. Oliver Kingsley, president and chief
nuclear officer of the Exelon Energy Corporation; Ms. Gary
Jones, associate director for energy, resources, and science
issues at the General Accounting Office; and Mr. Steven Fetter,
managing director of Global Power Group, Fitch IBCA.
We will begin testimony with Mr. Colvin.
Mr. Colvin.
STATEMENT OF JOE F. COLVIN, PRESIDENT AND CEO, NUCLEAR ENERGY
INSTITUTE
Mr. Colvin. Thank you, Chairman.
Chairman Voinovich, I really appreciate your holding this
hearing. I have submitted my testimony for the record in
written form, and I would like to summarize that for today.
Today I'd really like to focus on three key points. First
is nuclear energy's important role in a comprehensive national
energy policy for our Nation; second, the clean air benefits of
nuclear energy; and, third, regulatory oversight of the
industry.
First, national energy policy. Nuclear energy in the United
States is really a tremendous success story and has played a
major role as one of the engines driving our country's economic
growth. Our 103 nuclear power plants that are operating provide
over 20 percent of our Nation's electricity. They provide that
electricity safely, reliably, competitively, and, importantly,
without the release of pollutants to the environment.
In fact, the increase in nuclear power production over the
last decade has accounted for nearly one-third of the growth in
electricity demand during that time period, and nuclear
industry production has provided a hedge against disruption of
our electricity supply.
Nuclear power plants are really a mainstay of our
electricity grid. They can operate at full capacity for up to
18 months without refueling, and they are far less susceptible
to disruptions by weather and other electricity sources.
The second point I wanted to mention briefly are the clean
air benefits of nuclear energy. Nuclear energy plays a vital
role in protecting our air quality and is the largest source of
emission-free U.S. electricity. Nuclear power plants are also
vital to meeting our Clean Air Act emission standards for both
sulfur dioxide and nitrous oxide, and if nuclear were removed
from the energy mix many States and regions simply could not
comply with the requirements of the Clean Air Act.
Our electric generating facilities in our Nation, as we
move forward to supply the energy needs, face significant
emission reduction requirements. The nuclear power plants
really, by preventing air pollution, play a major role in
pollution compliance. In fact, the United States simply cannot
meet the broad spectrum of Clean Air Act requirements without
continuing and expanding nuclear technologies.
My last point, Mr. Chairman, is regulatory oversight. In
April of 2000 the Nuclear Regulatory Commission implemented the
new regulatory oversight program, and that has been a
tremendous success and, in my view, a program for which all
Government agencies that have a regulatory oversight role
should look at and basically follow.
This program really focuses attention sharply on safety and
is the first step in the path to regulatory reform. The next
step, in our view, is to revise the NRC's regulations to
incorporate the risk insights and performance-based approaches
consistent with those that are used in the regulatory oversight
program.
Progress on this second step has been slow but is moving
forward, and today the NRC must decide how to treat equipment
previously categorized as safety-related but which, with the
tools and techniques of today, has proven to have little or no
safety significance.
We believe that commercial and industrial standards apply
to that equipment. They essentially function the same, but the
cost difference and the impact is enormous. For example, an
industrial grade 10-horsepower electric motor purchased in
commercial grade may cost $350 to $400, but if purchased as a
safety-related item that nuclear grade may cost as much as
$20,000.
Regarding new plants, we are poised to begin ordering and
building the next generation of nuclear power plants, and we as
a Nation cannot afford to repeat the problems of the past. In
this area, the nuclear licensing process remains essentially
untested. Investors need to have confidence that this process
will be predictable, reasonable, and consistent.
This is an area, Mr. Chairman, that your committee can help
greatly by supporting NRC improving these important processes.
In summary, I'd like to just say that nuclear power plants
have outstanding safety records, high reliability, low stable
prices, and are critical to protecting the environment. Nuclear
is the only large source of electricity that is both emission
free and readily expandable. Nuclear energy is also a vital
energy source for the future and to meet our Nation's energy
needs, and in order to do that your committee's oversight and
support of the NRC to continue the changes in regulatory
changes are necessary to keep pace with the changing technology
and the growth in the marketplace.
Mr. Chairman, that concludes my oral statement. Thank you.
Senator Voinovich. Thank you very much.
Mr. Lochbaum.
STATEMENT OF DAVID LOCHBAUM, NUCLEAR SAFETY ENGINEER, UNION OF
CONCERNED SCIENTISTS
Mr. Lochbaum. Good morning, and thank you for the
opportunity to appear before this subcommittee.
I agree with Mr. Colvin on the success of the NRC's revised
reactor oversight program, but I'd like to spend my time this
morning talking about a few problem areas we think the NRC
needs to address in the near term.
Dr. Joe Hopenfeld--retired from the NRC staff last week--
had raised concerns about the integrity of steam generator
tubes to his management nearly 10 years ago. His concerns are
important safety issues, because broken steam generator tubes
can cause both the loss of coolant accident and a failure of
the reactor containment. This literally can be a deadly
combination.
The NRC basically ignored his concerns until an accident
last year at Indian Point Two which was caused when a cracked
steam generator tube failed. The ensuing public outcry and
Congressional attention forced the NRC to finally look into
Hopenfeld's concerns.
The NRC asks its Advisory Committee on Reactor Safeguards
to evaluate its concerns, and the ACRS reported its findings in
February of this year.
In the 10 years since Hopenfeld first raised his concerns,
the NRC allowed many nuclear plants to continue operating with
literally thousands of steam generator tubes known to be
cracked. The ACRS essentially concluded the NRC staff had made
these regulatory decisions using incomplete and inaccurate
information.
The NRC must really resolve Dr. Hopenfeld's concerns as
soon as possible. In the meantime, the NRC must stop making
decisions affecting public safety when it lacks ``defensible
technical bases,'' as the ACRS concluded.
Two of the NRC's four strategic goals are to maintain
safety and to reduce unnecessary regulatory burden. The agency
uses plant-specific risk studies to draw a nice clean line
between what is and what is not necessary burden.
The UCS released a report last August detailing serious
flaws in these risk studies. For example, we compared the risk
study results for three sets of identical plants and found that
they varied widely, not because the risk at the plants varied
that widely, but because the methods, assumptions used in the
studies varied widely.
Consequently, it is easy to move that nice, clean line
simply by adjusting the inputs and causing a burden to be
necessary or unnecessary, as you wish.
The studies we reviewed were nearly 10 years old, but they
are the only studies that are publicly available. The
previously cited ACRS report on Hopenfeld's concerns suggests
that the more-recent studies that are not publicly available
are equally flawed; yet, the NRC allows plant owners to reduce
the testing frequency for safety equipment and to continue
operating with degraded equipment based on the results from
these risk studies.
UCS and other groups cannot challenge these regulatory
decisions because we lack access to the risk study information.
The agency is essentially making regulatory decisions in a
vacuum. The NRC must require the that risk studies be corrected
and then make the corrected risk study results publicly
available.
The pebble bed modular reactor is mentioned as the nuclear
plant most likely to be built in the United States in the
future. Proponents claim that the pebble bed reactor cannot
melt down. Perhaps that is true, but can it catch on fire, as
happened in Windscale in 1957 and Chernobyl in 1986? Can plant
workers, either by mistake or by design, trigger an accident,
as occurred at Dresden Unit 3 in 1974 and Browns Ferry in 1975?
Can some unexpected component failure cause fuel damage as
occurred at Fermi Unit 1 in 1966?
It appears that the pebble bed reactor achieves its low
cost estimates by simply discarding the steel-lined reinforced
concrete containment structure that's used at our existing
nuclear power plants today. The ACRS has termed this ``a major
safety tradeoff.'' A facility like the proposed pebble bed
reactor has never been constructed or operated on the planet.
Consequently, its expected performance characteristics are
highly speculative. It would not be prudent at this time to
place undue reliance on the risky technology with unproven
safety performance. Nuclear experiments belong in a laboratory,
not in our back yards.
Nuclear power plants are inherently dangerous. If nuclear
power is to play an expanded role in our future, it is
imperative that the NRC become a consistently effective
regulator. UCS believes that this goal is attainable, as
evidenced by the revised reactor oversight program and the
maintenance rule. UCS believes that the agency may require
additional resources to meet this goal. Because the NRC is
currently a fee-based agency, it may require legislative
changes to supplement the existing resources that the agency
receives.
If Congress wants an expanded role for nuclear power, we
feel it must provide the NRC with the resources needed for the
agency to consistently regulate nuclear power, and must also
continue to oversee the NRC with hearings like this to ensure
that these reform efforts are successful.
Thank you.
Senator Voinovich. Thank you.
Our next witness is Mr. Kingsley.
STATEMENT OF OLIVER D. KINGSLEY, JR., PRESIDENT AND CHIEF
NUCLEAR OFFICER, EXELON CORPORATION
Mr. Kingsley. Thank you very much, Mr. Chairman, Senator
Inhofe. I appreciate the opportunity to speak to you.
I'm going to cover two subjects--it is all in my written
testimony--but what we need to do with it currently to improve
it and what we need to do to foster the industry going forward.
I thought it would be appropriate to talk a little bit
about my background. I have worked 36 years in this business.
I've started up, I've managed, I've licensed, I've ran all
support, and I've turned around three nuclear programs. I ran
the TVA program for some 9 years, ran the entire TVA power
program for 3 years, so I have a lot of insight into a number
of questions that you've asked. We currently manage the largest
nuclear fleet in the United States.
On the current plants we need to continue to focus the NRC
on certain key initiatives. We need to build on their recent
successes.
I have been quite impressed, having dealt with the NRC for
31 years, what they have accomplished. The reactor oversight
process, the renewal of operating licenses, which we will file
in the near future on a number of our plants to renew these
licenses, and the timely processing of licensing actions, so I
applaud that and they do come in on time and on schedule.
On a going-forward basis, we need to continue to focus on
regulatory reform. We have just scratched the surface of what's
out there. There's still too much bureaucracy, still too much
regulation, so the word is ``change.'' And I can tell you from
my time at the TVA this can certainly be done.
We need to license this geological repository for our high-
level waste. That's very important that we get that done. We
need a competitive fuel market. The United States and Richmond
Corporation's charges of anti-dumping are simply not valid. We
cannot get down to one source of enrichment and we cannot let
this industry fall prey to having a monopolistic price
control--very important. It's very important we modernize the
enrichment facilities in our country.
We also need targeted R&D that supports production, helps
us eliminate some of the unnecessary regulation, and is very
safety focused.
On a going-forward basis, we need a national energy policy
that clearly recognizes nuclear power. There's only really
three sources out there. You've got coal, you've got gas, and
you've got nuclear, and we play a vital role in that on a
going-forward basis.
We are very much behind expanding the nuclear business. We
are invested in the pebble bed modular reactor, and we want to
bring it to development in this country. There are a number of
changes required in order to ensure that the pebble bed can be
licensed and operated safely in the United States. First, we
need a licensing framework for this new plant. It must include
gas-cooled reactors. It needs to be safety focused and risk
informed. It needs to address economic impact that the current
regulations and laws bring about unnecessary economic impact on
this reactor. We need changes in Price-Andersen to accommodate
the pebble bed modular reactor. We need changes in NRC fees,
which currently on a unit basis where this is a modular
reactor, that needs to be changed. And there are a number of
other specific issues that need to be addressed, such as
operator staffing, etc., to accommodate that.
I mentioned Price-Andersen. We need to renew that, but we
also have to have it for new plant development. The older
plants will be grandfathered, but it is absolutely a must and
we must treat an entire site as a single facility, not an
individual reactor.
We also need to continue with the stable regulatory
environment that we have. We must exercise a number of unproven
policies that are currently on the books--the one-step
licensing process, early citing, combined operating license,
design certification for the pebble bed modular reactor. And we
need to continue this with the same rigor and discipline that
the NRC has demonstrated schedule-driven, high-quality product
output in some of the positive aspects that they have done that
I talked about earlier.
We feel that the cost to design this plant, the pebble bed,
should be borne by the investors, but we do feel very strongly
that the first-of-a-kind regulatory changes need to either be
funded by Congress or some way the NRC needs to absorb this
since we are the game in town, we intend to bring nuclear power
back.
This concludes my prepared remarks. Thank you very much.
Senator Voinovich. Thank you, Mr. Kingsley.
Ms. Jones.
STATEMENT OF MS. GARY JONES, ASSOCIATE DIRECTOR FOR ENERGY,
RESOURCES, AND SCIENCE ISSUES, GENERAL ACCOUNTING OFFICE
Ms. Jones. Thank you, Mr. Chairman. I'm pleased to be here
today to discuss the challenges that NRC faces as it implements
a risk-informed regulatory approach. Implementing such an
approach for commercial nuclear power plants is a complex,
multi-year undertaking that requires basic changes to the
regulations and processes NRC uses to ensure safety. The first
challenge is to develop a road map to guide the agency through
this complex process.
In March 1999, we recommended that NRC develop a clearly
defined strategy to describe the regulatory activities it
planned to change to risk informed, the actions needed to
accomplish this transformation, and the schedule and resources
needed to make these changes.
While NRC developed a plan to address our recommendation,
we believe it should be more comprehensive to cover areas such
as resource needs, performance measures, or how various
activities are inter-related.
One part of the risk-informed approach that has been
implemented is the new safety oversight process for nuclear
power plants. It was implemented in April of 2000, and the
challenge for NRC is to demonstrate that the new process
maintains the same level of safety as the old one, while being
more predictable and consistent.
The nuclear industry, States, public interest groups, and
NRC staff have raised questions about various aspects of the
process, including some of the performance indicators selected
and the difficulty in assessing activities that cut across all
plant operations, such as human performance.
The planned NRC assessment in June after the first year of
implementation would be an opportune time to begin to oversee
how well this new process is working.
When looking to apply a risk-informed regulatory approach
to nuclear material licensees, NRC needs to overcome a number
of inherent difficulties. Of most importance, the sheer number
of licensees, almost 21,000, and the diversity of activities
they conduct, such as converting uranium and using radioactive
material for industrial, medical, or academic purposes
increased the complexity of developing an approach that would
adequately cover all types of licensees.
In addition, the diverse activities of the facilities that
produce fuel for nuclear power plants makes it particularly
challenging for NRC to design a one-size-fits-all safety
oversight process and to develop indicators and thresholds of
performance.
In addition, as the number of regulatory agreements with
States increases beyond the existing 32, NRC must continue to
ensure the adequacy of the State programs, as well as its own
ability to oversee licensees that are not regulated by an
agreement state. Therefore, NRC will have to assess its staff
size, the skill mix, and the location, and the decisions that
it ultimately makes on these fronts could have budgetary and
other implications for the Agency.
Another challenge for NRC will be to meet its performance
goal to increase public confidence in NRC as an effective
regulator. This will be difficult because NRC has not defined
the target public and does not have a baseline from which to
measure the increase.
To address this goal, NRC instituted an 18-month pilot
effort to obtain feedback at the conclusion of public meetings.
NRC will ask for information on the extent to which the public
was aware of the meeting and whether the information was clear
and complete. It is not clear, however, how this information
will be used to show that public confidence in NRC as a
regulator has increased.
As you noted, Mr. Chairman, like other Federal agencies,
NRC is challenged to replace a large percentage of its
technical staff and senior managers who are eligible to retire.
For example, within the Office of Nuclear Reactor Regulation
about 42 percent of the technical staff are eligible for
retirement. This potentially high attrition could impact
license extension and other activities.
The ability to hire and retain staff is compounded by the
tight labor market for experienced professionals, and, as
mentioned earlier, the declining enrollments in nuclear
engineering programs.
NRC has developed a plan to maintain core competencies it
needs, and from an overall standpoint, the plan appears to have
all the elements to address the challenges; however, its
implementation over the next 5 years will face numerous
difficulties, and human capital management is another critical
area to watch.
Mr. Chairman, in a sense the NRC is at a crossroads. It is
making a major change to the way it regulates safety, and is
making this change at a time when marketplace competition is
driving decisionmaking on the purchase and operation of nuclear
facilities, and with relicensing, potential for new plant
construction, and NRC regulation of DOE facilities such as
Yucca Mountain, NRC staff are being asked to do more. These are
some of the same staff that NRC may lose to retirement.
Given the magnitude of these changes, continued strong
Congressional oversight will help to ensure that safety is
still the over-riding consideration in nuclear operations.
Thank you.
Senator Voinovich. Thank you.
Mr. Fetter.
STATEMENT OF STEVEN FETTER, MANAGING DIRECTOR, GLOBAL POWER
GROUP, FITCH IBCA
Mr. Fetter. Thank you, Mr. Chairman and members of the
subcommittee. I appreciate the opportunity to continue
discussions about the appropriate role for the Nuclear
Regulatory Commission in the evolving utility competitive
environment.
As I've testified before, both debt and equity investors
study closely the policies and actions of the NRC when
evaluating utilities that operate nuclear facilities. I am
happy to say that the NRC's actions since this subcommittee's
oversight hearing in July 1998 have been very encouraging.
Indeed the united front that the NRC showed today was very nice
compared to, I think at the 1998 hearing, there was at least
one dissenting opinion at the table that day.
The NRC has allowed stakeholders' input as it has modified
its policies to focus on safety-related issues in an objective
fashion. Using clear standards based upon individual plant
characteristics has allowed the Agency to direct its attention
for maximum impact.
Earlier today NRC Chairman Meserve testified about his
goals and his colleagues' goals at the NRC. These included: to
reduce unnecessary burdens so as not to inappropriately inhibit
any renewed interest in nuclear power, and to maintain open
communications with all of its stakeholders to seek to ensure
full, fair, and timely consideration of issues.
These goals, together with the NRC's support for extension
of the Price-Andersen Act, are music to investors' ears.
Indeed, far from the refrain that many industry watchers were
humming in 1998--that nuclear might be dead in a competitive
environment--last week Fitch rated the Exelon Generation
Company--Mr. Kingsley's non-regulated generating company that
has 17 nuclear plants--at triple-B-plus, a very respectable
investment grade rating.
Finally, let me mention the elephant in the corner--the
disposal of spent nuclear fuel. Choosing and developing a
permanent site for the disposal of spent fuel is a necessity.
Before we see progress on planning for the construction of a
new generation of nuclear plants, the waste issue must be
resolved. Any delay in achieving this goal likewise delays the
ability of the nuclear industry to assist in the country's
future electricity needs.
Thank you.
Senator Voinovich. Thank you very much.
We have been joined by Senator Corzine from New Jersey, and
Senator Corzine is pretty fortunate in that 70 percent of the
power in his State is generated by nuclear power, and so he is
pretty familiar with the benefits of it.
Senator Corzine, do you have a statement that you would
like to read before we ask for questions?
Senator Corzine. I'd just ask that it be put in the record.
It is actually 50 percent but it is an important part of
our energy sources, and we have a major medical investment, as
well, that it is a very keystone research effort on it.
I'm excited about getting myself informed, and I very much
appreciate the panel's efforts. I apologize for not being here.
As I'm sure you've heard, we've had multiple hearings this
morning and votes. But I intend to study your testimony and I
appreciate very much this hearing, Mr. Chairman. It is a
terrific effort that needs to give us all a framework to
actually debate these in an intelligent way.
[The prepared statement of Senator Corzine follows:]
Statement of Hon. Jon S. Corzine, U.S. Senator from the
State of New Jersey
Thank you Mr. Chairman.
Mr. Chairman, the issues before the committee today are extremely
important to the people of New Jersey. My State has four nuclear
generators, and together they represent approximately 50 percent of the
electricity generated in New Jersey.
NRC regulation of these facilities therefore has important
implications for the New Jersey economy. Other uses of nuclear
material, such as nuclear medicine, are also important to my
constituents. As a result, I am concerned that NRC regulation be as
effective and efficient as possible.
More importantly, however, I am concerned about safeguarding public
safety and the environment. Changes in NRC regulations should not
unduly compromise these goals.
I believe that science and common sense can and should guide the
NRC's balancing of safety and efficiency. ``Risk-informed regulation''
is the stated underpinning of the NRC's efforts to modify its
regulations. This phrase ``risk-informed regulation'' sounds appealing,
and may hold the promise of a proper balance. But the issues are
complex, and I want to learn more about how the NRC is proceeding.
So I look forward to the testimony of our witnesses. I am
particularly interested in their assessments of the validity of the
approach that the NRC is employing in developing ``risk-informed
regulations.'' Within this issue, I am most interested in hearing the
panelists' perspectives on the new reactor safety oversight process.
With that, Mr. Chairman, I conclude my remarks.
Senator Voinovich. As the panelists know, I am very
committed to seeing if we can increase the productivity of the
current existing facilities and to go forward with new
construction of new facilities.
I would be interested to--Mr. Lochbaum, you have been
watching it and you mention in your testimony that you are
concerned also about the staffing capability in terms of paying
attention to the safety aspect of this, and that's really
important, because, you know, one bad accident and here we go
again.
I assume your organization is not opposed to nuclear power?
Mr. Lochbaum. No. We basically sit on the fence. We neither
think it is the best answer for the future, we're also not
anti-nuke, so we get shots from both sides. The benefit is we
get twice as much practice ducking.
[Laughter.]
Senator Voinovich. Twice as much what?
Mr. Lochbaum. Practice ducking.
Senator Voinovich. Yes. But you are concerned about that,
and it just seems like it is across the board. I guess the
point is that we are interested in having the people that can
process the applications, and so on and so forth, but we are
also interested in making sure we've got the people that are
going to go out there and make sure that the safety aspect of
these things is stayed on top and we don't get careless with
that. That would be a disaster for everyone.
The question that I would like to ask is Mr. Fetter. To
build a nuclear power plant or even to maybe put some stuff in
to increase its capacity costs money, and usually companies
come to Wall Street and ask for money.
Mr. Fetter. Sometimes.
Senator Voinovich. Sometimes. Assuming that the people that
are going to move forward to build some more of these
facilities--you know, we create an environment for that to
happen--I'd like you to re-emphasize how important it is in
terms of the decisionmaking in terms of what we do with this
stuff. It has been around.
It has been around--as I mentioned in another hearing, I
was the County Commissioner in Cuyahoga County in 1977 when
they talked about storing nuclear waste in the salt mines under
Lake Erie, and at that time I wasn't real enthusiastic about
that, and we've now moved to Nevada and Yucca Mountain, but
tell us about that. How important is it that we get this thing
over with? And if we don't, what impact do you think it's going
to have in terms of you guys looking at it?
Mr. Fetter. Well, I think that before there's going to be
financing for a new generation of nuclear plants, the spent
fuel issue has to be resolved. Certainly, based upon the
comments of Senator Reid this morning, he has an interest in
the proceedings at Yucca Mountain.
From Wall Street's point of view, a resolution must be
found, and if Nevada is the best place, then it may have to be
chosen over the objections of elected officials in that locale.
If Nevada is not the right place, then the Congress and the
Administration should move forward and find where that better
location is, because there will not be another round of nuclear
construction until that issue is resolved.
Senator Voinovich. Ms. Jones, you have--GAO has looked at
it, and you really believe that the NRC has done the work
necessary to determine the number of people and quality of
individuals they have to do the job that they have to do now
and in the future, assuming more licensing, perhaps new
facility? Do you think they nail that down?
Ms. Jones. What we've looked at, Mr. Chairman, is their
overall plan and what compared it against GAO's framework that
we came up with because of the human capital problems across
Government. We looked at it from the standpoint: does it have
the elements of strategic planning? Is it looking at succession
planning? Is it looking at having the right performance
culture?
So, from a very broad brush, without looking at the
specific details behind it, it does have the right elements in
it. But whether or not it is going to do the trick, I think
only the implementation of it over the next 5 years will tell.
It is going to be very critical for us to watch.
Senator Voinovich. OK. So they've got the plan. Your
concern is are they going to be able to implement the plan in
terms of retention and attracting people to the agency?
Ms. Jones. Correct. Will they carry through the plan that
they've put in place? Will they really define the mission needs
that they have, the skills and abilities, and then have a plan
in place to get those people?
As you and others have mentioned, there's a lot of outside
factors that are going to make it more difficult for them to
even carry out their plan.
Senator Voinovich. Now, do you just work at the NRC or do
you kind of go from agency to agency to look at this issue?
Ms. Jones. GAO has looked at it across the Federal
Government, and I think, Senator, as you are aware, GAO has
said that human capital management is a high risk area for all
the Federal Government at this point in time.
Senator Voinovich. Right.
Ms. Jones. It is really critical because it is going to
impact other agencies' ability to get their missions done in an
effective, efficient way.
Senator Voinovich. Well, as you know, we're working with
Comptroller General Walker on this and many other people----
Ms. Jones. Absolutely.
Senator Voinovich [continuing]. To give it the high profile
it needs and do something about it, but the question I have is:
has GAO gone into all of the other Federal agencies and done
the same thing that you're talking about today to see if they
have a plan in place to deal with their human capital crisis,
or is it just the NRC that's out in front?
Ms. Jones. We have done it in some agencies, Senator
Voinovich, not for all. For example, we've done some limited
work at the Department of Energy looking at their Defense labs
and what plans they have in place to address some of the same
kinds of challenges the NRC has for technical staff. But in
terms of doing a very detailed analysis of every Federal
agency, no, we have not. We've done it for some and are doing
it for others now.
Senator Voinovich. Well, with my other subcommittee
chairmanship hat, I would like if you can go back to the Agency
and ask them if they could give me a little report on the
status of those agencies that they have reviewed, like you have
with the--I'm delighted to hear that you've done that, because
one of my concerns with--and I've talked with Shawn O'Keefe or
with Mitch Daniels--is, you know, have those agencies even
looked at where they're vulnerable, and what you're saying to
me is in the case of the NRC they have done that.
Ms. Jones. NRC has begun to do that and they do have a plan
in place, and from a very broad brush they have the right
elements in the plan. I think we probably would want to look at
the details behind it to make sure that they have all the I's
dotted and the T's crossed.
Senator Voinovich. Yes.
Ms. Jones. But we'd be happy to get back with you on the
other agencies.
Senator Voinovich. Thank you.
Senator Inhofe.
Senator Inhofe. Thank you, Mr. Chairman.
Mr. Colvin, it seems as if, in the last short period of
time, there have been a lot of favorable press on nuclear
energy relative to a few years back. I just wondered what you
would attribute that to.
Mr. Colvin. Senator Inhofe, I think as we look across the
problems that our Nation faces in energy, and whether it be in
electricity, in gasoline prices going up, in providing home
heating oil and natural gas over the last winter, I think we're
seeing a recognition of the important role that energy plays in
our economic growth, and that resonates with the individual
member of the public.
We've seen that really come about in nuclear energy. I
think, to digress just a moment, the industry really has seen
support, public support in the area of two-thirds of the public
for many, many years supporting the use of the technology. That
has been somewhat unwavering over time. What we have seen,
however, is a change in that as people recognize the energy
needs and the recognition of the need to, in fact, build more
nuclear power plants or expand our use in this technology.
For example, in polls that we ran last year and the year
before, we saw 24 to 30 percent increases in support for use of
nuclear technology across the United States, probably more in
the west. Just as an example, in California and the western
States, in October 1999 we had about one-third of the public
supporting nuclear as compared to the rest of the country. In
March of this year it was 62 percent in the west supporting
nuclear. So, as people see the importance of energy as they, in
fact, lose the opportunity to have electricity for even short
periods, it brings that home.
We've just done some other public opinion research that
will be released. Later today I will be happy to share that
with the committee. But really, I think the public recognizes
that 10 to 20 years in the future that the major source of
electricity in the United States from a fuel source perspective
from the public's view would be nuclear followed by solar.
Senator Voinovich. Yes, and I think we're all concerned
about alternative sources and efforts are taking place right
now, but I would feel--you know, we went through several years
of problems with ambient air and all that and the public was
kind of made aware that there are some problems there, and all
of the sudden they say, ``Well, in this area there isn't a
problem. CO<INF>2</INF> is not an issue.'' Mr. Colvin. Yes,
sir. That's correct.
Senator Voinovich. But, Mr. Lochbaum, you say that you're
on the fence so everyone can shoot at you. I'll go ahead and do
that.
If you don't use nuclear and expand nuclear, what are the
choices out there, because, in terms of today's science, we
know it works. We also know about coal. We know about natural
gas. But when you add it up as to the needs that are there, and
not just the potential problems but existing problems, you
know, you take that into consideration as to--what are the
choices now.
Mr. Lochbaum. Our organization, along with several other
environmental organizations, has done a number of studies in
the last 3 to 5 years looking at meeting energy needs as
projected by the Department of Energy and what resources are
available today to meet those needs, and what the conclusions
consistently show is that increased reliance on renewable
energy technologies--fuel cells, biomass, wind power, solar
power, and so forth--can meet those needs with--an assumption
we make in those studies is that the existing fleet of nuclear
power plants runs to the end of their operating lifetimes.
Senator Voinovich. Well, you talked about the 10 years,
your risk studies are 10 years old, and then you painted a
pretty bleak picture on some of the steam pipes rupturing and
this type of thing. Mr. Kingsley, would you like an opportunity
to respond to some of the statements that were made by Mr.
Lochbaum in his opening statement?
Mr. Kingsley. Yes, I would, Senator Inhofe.
First, on the steam generators, we have very thorough
inspection programs. We have very good emergency operating
procedures to handle any of that. We have early detection
techniques that allow--so we believe that all of our steam
generators are very safe, they are operated safely. Our
operators are trained to handle that.
With respect to the pebble bed modular reactor, there are
some technical issues that we are in the process of resolving.
Senator Voinovich. Could you just tell me what pebble bed
is? I mean, we've heard it, and I probably should have picked
it up from reading, but what is pebble bed?
Mr. Kingsley. It got its name, Senator, if you were to
imagine a very, very large number of ceramic balls about the
size of a pool ball where you've got small chips of uranium in
a ceramic there, and that's in what we call a ``reactor.''
Helium gas passes through this, and so that's where you get the
``pebble bed'' out of that. The helium gas is heated and that
goes on over.
Senator Voinovich. Science. OK.
Mr. Kingsley. Yes, we won't go into it any further detail.
Senator Voinovich. It's not Pebble Bed, California.
Mr. Kingsley. Right.
Senator Inhofe. Is that all cleared up?
[Laughter.]
Mr. Kingsley. It's a little more than a pebble.
Senator Voinovich. Are there other questions on that?
Senator Inhofe. Well, let me ask a question of Mr. Fetter
over here. When we had our brownfields hearing, my major
concern is, all these people going out and talking about the
different ramifications of it, if you don't have something, a
product that the contractors will bid on, then it's not going
to make any difference because they're not going to bid. I came
from that segment of industry and I know that if there are too
many uncertainties they won't do it.
The same I'd say is true with you. If there aren't
investors out there that are going to look at the risks and
make their evaluations and put their money into the
construction of new nuclear plants, then it doesn't make any
difference what we're talking about here, there aren't going to
be any.
So I'd like to ask you, I think you inferred in your
testimony that the market is much better now than it was a
short period of time ago, and what do you look for in the
future for that?
Mr. Fetter. I think just what we're seeing in California.
In my testimony I noted that 3 years ago at the time of the
first hearing, nuclear didn't have a place and California was
held up as the model for the future. I think the problems we're
seeing are a lack of supply for the demand that's growing, and
there is clearly a need for more electricity. If it comes from
nuclear power, there will be investors to provide for
construction, but only if the uncertainties that you referred
to get cleared up.
I said the biggest uncertainty is spent fuel. There are
other uncertainties that are mentioned throughout the
testimony. But investors are interested in making money. The
more uncertainties that are laid on the issue, the less
interested they will be willing of taking that chance.
Senator Inhofe. And the higher the rates go, and that's
ultimately passed on.
Mr. Fetter. Yes.
Senator Inhofe. If they are successful.
I know my time is up, but I want to ask just one more
question of Mr. Fetter.
You talk about the triple-B-plus rating of the 17, I guess,
plants that Mr. Kingsley has. Now, I also come from the
insurance industry. I know what a Best rating is, but I'm not
sure I know how this--what a triple-B-plus rating is.
Mr. Fetter. Well, the rating scale would be triple-A,
double-A, A, then triple-B.
Senator Inhofe. As in bonds?
Mr. Fetter. This would be bond rating.
Senator Inhofe. OK.
Mr. Fetter. And triple-B-plus is well into investment
grade.
Senator Inhofe. Yes. Thank you.
Senator Voinovich. Senator Corzine.
Senator Corzine. Given that the spent fuel issue is such an
overwhelming concern, are there other models--maybe you all
talked about this in your testimony--but other models in other
countries that are much more committed to nuclear energy as a
source that we could learn lessons from more diffuse than going
into one site? Does anybody want to comment on that?
Mr. Colvin. Senator, Joe Colvin here. I'd be happy to at
least start that discussion.
First of all, in any technology such as nuclear we have to
protect the waste from the environment for many, many years. In
this case, those years are a little longer than perhaps some
other types of technology, but we manage that waste and have
managed that waste well and protected it from the environment.
The challenge that we have today is to move forward and dispose
of that waste byproduct for many, many years into the future.
There is a lot of cooperative sharing that goes on between
various countries, but ultimately, no matter what process,
whether you reprocess, recondition the fuel, or reuse it such
as the French and the Japanese are doing, or use a once-through
fuel cycle such as we're using in the United States, ultimately
you have to have a repository or a place to store the waste
byproducts, and that is a deep geologic repository.
Senator Corzine. The French reprocess the fuel, though?
Mr. Colvin. The French have chosen to reprocess the fuel,
and they take the fuel out of the reactors, reprocess it, put
the usable product back into the new fuel and put it back in
the reactors, and they do that typically two to three times
before that is no longer usable.
Then they take the remainder of that waste byproduct and
they plan on ultimately putting it in some type of deep
geologic repository to protect it for the environment for many,
many years. Our choice was also geological repository, and
that's what is being studied. It's being studied at Yucca
Mountain. The Department of Energy issued their science and
engineering reports last Friday and have begun the process to
move forward to a recommendation for suitability, which is
scheduled to occur some time in the latter part of this year.
Senator Voinovich. It's my understanding, too, isn't
there--they're contemplating building one of these deep
depositories in The Netherlands someplace?
Mr. Colvin. Yes, sir. That's correct. I think each of the
countries that is looking at this has used the technology as
looking at, in fact, some type of deep geologic repository. The
Fins and the Swedes, for example, have decided that they will
emplace this in the bedrock underneath the Baltic Sea. That
turns out to be a place that they've evaluated. In the United
States we studied many sites--salt deposits, granite deposits,
and ultimately volcanic tough, which is the Yucca Mountain
site, and the process went through and chose the Yucca Mountain
site for a determination of suitability. So there are many
different processes that are being looked at by the various
countries.
Senator Corzine. We have a dispersed system now, though. If
I understand correctly, in New Jersey they actually store the
spent fuel at the site. Is that not a long-run acceptable
format for dealing with spent fuel? Is it one option?
Mr. Colvin. Well, I think in the storage of spent fuel we
have to go back to 1954 and the Atoms for Peace program made
the decision, as a Government policy, that the waste from these
reactors would, in fact, be the responsibility of the
Government, although the industry that would use this would pay
for this technology. And so as these plants were designed, they
were designed to store the fuel in a wet storage inside the
fuel pool for a number of years that was sufficient to allow
the fuel to cool off, and then to have the Government take that
fuel and put it in a deep geologic repository, and that was the
plan. That was the plan starting in 1954 and, in fact, the
Department of Energy had the responsibility to begin accepting
that fuel in 1998.
Since the DOE could not meet that commitment for a number
of reasons--which we could discuss, I'm sure, at length--and
that's the process that is ongoing, then the companies had to
take some alternative action, which was, in fact, to expand to
a dry cast storage at those sites.
The NRC has testified and the National Academies have
looked at this issue in depth, and their reports indicate that
the safest and most responsible way to manage this waste
byproduct is to move it from the 60 or 70 locations in 31
States to a centralized facility at the site where the
permanent repository is going to be operated, and that's the
process that is in place and moving forward today.
Senator Corzine. Thank you.
Senator Voinovich. Senator Corzine.
Senator Corzine. I'd go to Mr. Fetter in one sense. Has
there been a lot of debt issuance to support the industry? When
I left the bond business about 2 years ago, you couldn't raise
any capital?
Mr. Fetter. I mean, certainly, as we mentioned with regard
to Exelon, Amaren, and PSE&G Power, there is support for
nuclear-owning generation companies, and so the mood has very
much changed in the 2 years since you left.
Senator Voinovich. OK. Any other things?
Senator Corzine. No, thank you.
Senator Voinovich. I'd like to have the panel's comment on
two things. Following up on Senator Corzine's question about
Yucca and deep geological, can anybody bring me up to date on,
if it was approved, how long would it take? And it's my
understanding there's some talk about a temporary facility in
Utah to hold this material until it is ready to go to Yucca
Mountain, assuming Yucca Mountain is approved. That's one
question.
The second question deals with one, Mr. Kingsley, you
mentioned, and I am real interested in what's going on with
USEC. I've followed that one since I was Governor, and I read
recently--I think it was yesterday--in the paper that the issue
of they are negotiating a contract with Russia, who is now
sending us their uranium, and USEC claims they are paying too
much for it, and there is a glut of uranium on the marketplace
today. Your thoughts on whether we have an adequate supply if
we're going to move forward, and, if it isn't adequate, how do
we make sure it is adequate and who ought to run it? Maybe we
will start with that one for you, Mr. Kingsley, and we'll
follow up with Mr. Colvin or anybody else that wants to comment
after Mr. Kingsley.
Mr. Kingsley. A couple of issues. One of the big advantages
that we have in operating nuclear power plants is our fuel.
Typically, the fuel costs about $4.50 per megawatt hour, and it
has been extremely stable.
Senator Voinovich. That's $4.50?
Mr. Kingsley. Yes, $4.50.
Senator Voinovich. As compared to coal, which is about
$1.50, right?
Mr. Kingsley. That's exactly right.
Senator Voinovich. OK.
Mr. Kingsley. And that has been increasing markedly lately
in coal, particularly with the shift in the market to the
Powder River Basin coal with that.
So what we want to ensure is that--and we strongly believe
that enrichment is a service. We own the product, and we can
obtain enrichment on the world market, so that's at the key of
this issue.
Second issue that's also tied in to the fuel is that, with
the non-proliferation and the disposal of some of the highly
enriched uranium, that with that coming in and with USEC being
a sole agent, we don't want to be subject to what they might
charge for that uranium, blending it in. So that's the
principle. We want to protect a great advantage that we have,
and that's why we are very active in pursuing this with
Department of Commerce.
Senator Voinovich. You do not want to be the captive. Who
else besides----
Mr. Kingsley. We do not want to be captive. There are two
suppliers from Europe, Urenko and Cogema, that we obtain some
of this from. There's a charge by USEC that they are dumping on
the market here in the United States. They've had government
subsidies. So we want to protect the fact and actually have a
very competitive environment.
We also believe that there's a need to modernize the
enrichment facilities. Those were built a number of years ago
back there in the World War II times as a part of the atomic
movement at that time.
Senator Voinovich. But USEC is the only one in the United
States that does it?
Mr. Kingsley. They are the only ones that do that. That's
correct.
Senator Voinovich. And you are concerned that they
wouldn't, through some type of legislation, keep out
competition?
Mr. Kingsley. That's correct.
Senator Voinovich. Are you concerned if--let's say USEC
goes out of business. Would you argue that the Federal
Government should take it over and that we do have some----
Mr. Kingsley. We do need an enrichment source here in the
United States.
Senator Voinovich. You'd never get to a situation where----
Mr. Kingsley. No. Absolutely not.
Senator Voinovich. Got to have it?
Mr. Kingsley. Got to have it. Need to have it.
Senator Voinovich. For economy and for our national
security?
Mr. Kingsley. Right. Otherwise----
Senator Voinovich. If USEC goes under, the Federal
Government or somebody ought to take it over and make sure we
can keep it going?
Mr. Kingsley. Absolutely. Yes, sir. Look where we stand on
imports on oil and everything. We could be in that same
situation. We don't want to get caught up in that.
Senator Voinovich. OK. Now we've got the fuel, Mr. Colvin.
We've got to get rid of the waste.
Mr. Colvin. Yes, sir. Mr. Chairman, if I understood your
question, it had to do with the time to actually make the
repository operational and also the private fuel storage
initiative.
The schedule that the Department of Energy has underway is
to try to come to a decision on suitability, a recommendation
by the Secretary of Energy and a recommendation to the
President for Presidential decision some time around the end of
this year. If that decision was positive, that triggers a
number of steps with the State of Nevada and ultimately brings
the issue, assuming Nevada's challenge, back to the Congress
for a vote to override the veto of Nevada.
Once that process is beyond us, some time likely in the
middle of next year, then the DOE would submit a license
application to the Nuclear Regulatory Commission for processing
and start that process. From that point until the time that the
repository is in full operation is somewhere between 2010 and
2015, so we are on a very long timeframe schedule to actually
have a repository that would be in full operation.
Senator Voinovich. What about the temporary thing I just
mentioned in Utah?
Mr. Colvin. A number of the utilities, given the fact that
we have not had the Government meet its obligation to move fuel
off the reactor sites, have been working on licensing of a
private fuel storage initiative in support--this is supported
by the Goshute Indian Band in Utah, and this is a completely
private initiative paid for by a number of investors to license
and bring into operation a facility to, in fact, act as a
relief valve, if you want, on plants and companies that have
run out of fuel storage and that are under pressure from their
State and local governments to, in fact, move that fuel out of
their State and off of their site. So that is in the process of
being licensed currently by the Nuclear Regulatory Commission,
and I expect that that will move forward.
Senator Voinovich. So that's like a temporary--where some
of them don't want to store it at their place of business, they
would then send it out there and put it in a holding pattern
until the other thing is built?
Mr. Colvin. Yes, sir, that's basically it. And it would be
in the dry form--form of dry cast storage, above-ground storage
that, in fact, we see at some of the power plants that have run
out of space in their fuel pool storage today.
Senator Voinovich. One last question, to follow up with Mr.
Fetter. What is the key thing that you are going to be looking
at? We know that if the NRC says it is OK, Nevada will do
everything to say they don't want it. I guess you say then it
comes back to us for a vote, and if then we vote to override
their veto, then it becomes a reality?
Mr. Fetter. That's correct.
Senator Voinovich. Is that the thing that would trigger
Wall Street to say, ``Hey, this is going to happen?''
Mr. Fetter. Well, it would be that. I guess litigation
would follow that. And so at some point, after all the
litigation is done, then Wall Street pays more attention.
If I can make a comment about Senator Corzine's statement,
you raised the concept that if spent fuel is stored short-term
now at the plant sites, you wonder whether that could solve the
political issue longer term. It would seem to me that the three
issues that are being explored with regard to long-term storage
are long-term safety and health issues, physical security
issues, and then the political issue. Those are what are being
fought out.
I think if you resolve the political issue by storing it at
either one site in each State, or 50 sites, or at each plant,
so you'd have over 100 sites, long-term, you might solve the
political issue, but the other two issues would be much worse
off than finding one site somewhere in the United States to do
it.
Mr. Kingsley. And that would be just short term, I might
add, too. Eventually we'd decommission and we're going to have
to move this fuel offsite.
Ms. Jones. And also we've found in the low-level waste
program that we haven't been able to find States to host sites.
States do not want a site, even low-level waste, so I think the
point of finding locations in several States for high-level
waste would be very difficult.
Senator Voinovich, I also wanted to make a point on the
USEC question that you had earlier. I think USEC at this point
in time is in conflict because they have two roles. One role is
they are acting as the agent for the U.S. Government in a non-
proliferation program. That's the reason that they are buying
the enriched uranium from Russia. And they're also trying to
run a competitive market company. And I think that at times
these two roles are in conflict, and that's one of the reasons
they're running into the monetary problems they're running
into.
Senator Voinovich. Right. I think everybody knows the
largest amount of money that we give Russia every year is this
contract that USEC has. I think it is, like, $450 million a
year or something.
Mr. Lochbaum. It's huge.
Senator Voinovich. It's a huge amount of money.
Senator Inhofe.
Senator Inhofe. Mr. Chairman, I'm glad we had this
discussion, Mr. Kingsley talking about his recommendation
should we find--you know, we went through this thing. I can
remember when Don Hodel was Secretary of Interior in 1987. We
went around the country and tried to explain to people what a
crisis it was from a national security standpoint that we were
becoming more and more dependent upon foreign sources for oil,
and not an energy problem but a national security problem. I
think now people are aware of that. Back then it was below 38
percent dependency. Now it is approaching 60 percent.
I don't want to get ourselves positioned where we might be
facing that same problem in nuclear energy. I think that's
very, very significant that we're doing this.
I think it is a really appropriate time, Mr. Chairman, to
have this committee hearing because we are on the verge of
receiving a national energy policy, and I, Senator Corzine, as
a partisan Republican, let me tell you I'm just as upset with
Republicans as I am with Democrats. I remember when President
Reagan was President we went in to plead our case as to why we
should have a national energy policy, and then when Bush, Sr.,
was elected we thought, surely, coming out of the Midland Texas
oil fields he'd agree with that, and he didn't do it. Of
course, Clinton didn't do it. So now we are at the point where
it is going to be done, and I can assure you all the
indications are there and the statements made by the President
and the Vice President that nuclear energy is going to be a
very prominent part.
So we're right at that point now and it is the appropriate
time to be trying to resolve these problems.
Senator Voinovich. Senator Corzine.
Senator Corzine. May I ask Mr. Fetter what is the next big
risk issue aside from spent fuel? I'm under the impression that
liability insurance is pretty hard to get.
Mr. Fetter. The Price-Andersen Act extension would be very
important. I think we will also watch how Exelon and other
companies operating as non-regulated generating companies that
have a portion of their supply from nuclear power, how they
operate. As you know, with nuclear there are many things to
watch, but certainly over the past 5 years it has been a much
more positive story, and so I think Wall Street is much more
comfortable with the issue.
Senator Corzine. But we are going to have to reauthorize
Price-Andersen?
Mr. Fetter. Yes.
Senator Corzine. All right. Let me ask just another sort
of--I'm curious. Are there other sites other than Yucca
Mountain that were close that were not chosen as the site of
ideal location but met the terms and conditions that people who
would make judgments about where spent fuel should go were
identified?
Mr. Colvin. Senator, yes, sir, there were. In 1982 the
Senate and the Congress passed the Nuclear Waste Policy Act of
1982, and that began the process. The Department of Energy
evaluated a number of sites in the United States. I don't
remember the exact number, but there were tens of sites that
were screened, maybe even more, and they came down ultimately
to propose a characterization or review of three specific
sites.
The cost for that evaluation became very, very significant,
and in 1987 the Congress amended that act with the Amendments
Act of 1987 and selected the single site at Yucca Mountain for
characterization and suitability.
Since that time, through that process, we probably know
more about the ``ologies''--the hydrology, the meteorology, the
geology, the seismology, and so on--of that place better than
any other place in the universe, and that is the site, the
place that has been studied.
Now, whether there are other sites that might be available
should that site fail, that would have to be restudied and
reevaluated given the technologies and the science available to
us today that we may not have had, say, 20 years ago.
Senator Corzine. Ballpark figure on how much that study
would cost?
Mr. Colvin. I really don't know in today's dollars. The
current life cycle cost of the program is about $56 billion.
Ratepayers and utilities have paid in about $16 billion, and
we've spent about half of that in studying this one site, if
that kind of gives you at least a feel for the amount of money.
Senator Inhofe. Yes. Mr. Chairman, one last question.
Senator Voinovich. Go ahead.
Senator Inhofe. You touched on this, but if it ends up
going through the process where it is going to be Yucca
Mountain, what would be--in coming back and going through the
steps that you just outlined in response to the chairman's
questions, what would be the timeframe that that would be
finalized? And, second, if that is for some reason rejected and
we had to go into this other alternative, I'm equally concerned
about when as I am how much. So about how much longer would it
take if you were--if somehow Yucca was rejected in this
process?
Mr. Colvin. Senator Inhofe, I really don't have a good
estimate on that, but I think that if the Yucca Mountain
process, after the detailed scientific studies and engineering
analysis, would show that that site was not suitable for a deep
geologic depository, we'd basically be back at square one. I
think we'd have to go back and start this process anew,
because, I mean, after we've spent all that time and all that
energy and all that scientific review with the best minds that
we have working on it, I think we'd really be back at the
beginning.
Senator Inhofe. I think that should be determined, and I
think--Ms. Jones, do you have any comment about that, or would
you be able to try to analyze that scenario and then for the
record get back with us and let us know a time line that it
would take in the event that we had to reject the Yucca site.
Ms. Jones. We could certainly do that based on kind of
historical data about what has happened with Yucca Mountain.
Senator Inhofe. Yes.
Ms. Jones. But I would agree with Mr. Colvin that we would
be back to square one and have to look at one of these other
sites from the very beginning.
Senator Inhofe. Well, I do think it is necessary for us to
have some type of an idea, though, so if you could help us with
that we'd appreciate it.
Ms. Jones. We'll try to do that, Senator.
[The information referred to follows:]
Nuclear Waste Repository Time Line
1977 LUnited States Geological Survey recommends that DOE consider the
Nevada Test Site as a potential host for a mined geologic repository
for disposal of high-level nuclear waste.
1980 LYucca Mountain, on the western border of NTS, is selected for
eventual study as a potential repository site.
1981 LDOE formally decides on mined geologic disposal for spent
nuclear fuel and high-level radioactive waste.
1981 LNuclear Waste Policy Act of 1982 enacted.
1986 LPresident approves DOE's recommendation to characterize
(investigate) three candidate sites for the first repository (Yucca
Mountain, Nevada; Hanford, Washington; and Deaf Smith County, Texas) as
well as the cancellation of the program to screen and select a site for
a second repository.
1987 LNuclear Waste Policy Amendments Act of 1987 enacted. Yucca
Mountain becomes only site authorized for characterization by DOE.
1988 LDOE issues Yucca Mountain Site Characterization Plan.
1991 LDOE establishes major acquisition cost, schedule, and technical
baseline for developing a repository at Yucca Mountain by 2010.
1991 LDOE receives environmental permit from the State of Nevada and
begins site characterization.
1999 LDOE issues draft environment impact statement for a repository
at Yucca Mountain.
2000 LDOE issues notice of beginning of public comment period leading
up to projected decision by the Secretary of Energy in December 2001 on
whether the Yucca Mountain site is suitable for a repository.
2003 LIf Yucca Mountain is selected as a repository site, DOE would
submit an application to the Nuclear Regulatory Commission (NRC) to
construct the repository.
2010 LDOE expects to receive a license to operate the repository from
NRC and to receive the first shipment of spent fuel to be disposed of
in the repository.
Mr. Kingsley. I can tell you from a cost standpoint on the
operating side that you go out about 10 years, and then your
costs go up markedly, you know, with having to store onsite
that we talked about earlier, so it's going to hurt our
economic viability.
Senator Voinovich. That's a tough one. I know when we were
in the regional low-level waste disposal thing and when
Michigan decided they wouldn't to it, Ohio picked up the
responsibility, and I think I spent 3 or 4 years on just trying
to find a site in Ohio to try to do low-level radioactive
waste, and it is just incredible. It just would go on and on. I
figure low-level, that's 4 or 5 or 8 or 9 years, so I think
your point is well taken that if that isn't the case then we
really have a serious problem on our hands.
In my opening statement I said, ``If we are serious about
protecting our environment and providing safe, reliable, and
affordable electricity to all Americans, then we need to
improve how we burn fossil fuels, promote efficiency, increase
the development of nuclear energy for today and for the
foreseeable future. We also need to continue investing in
renewables such as solar and wind to make them cost-effective
and feasible, not for today or for tomorrow but for use at some
point in the future.'' One of the things that I keep running
into in the Senate--and if any of you have anything written
that you could help me--is that there is this attitude here
that somehow through conservation, through fuel cells, through
solar, through wind, through water, and so forth, all these
other things, that somehow we're going to be able to deal with
the energy problem that we have in this country. I'd like some
information on that, because it seems to me that some people
are denying the fact that we've got all this stuff that's out
there and we have made progress but put it all together, all
the research, all the stuff that we've got, with the demand
that we've got and where we are with some of those other
things, that if we don't have more nuclear power, if we don't
use clean coal technology to burn coal, if we don't look at
some of the refining capacity and all the other stuff that
needs to be done, we are going to be in deep, deep trouble
economically and from a national security point of view.
If any of you have got anything on this----
Mr. Kingsley. We'll be happy to submit on that, Senator.
And I can tell you unequivocally we do need research in some of
these areas, but if it is not with nuclear or if it is not with
clean coal or if it is not with natural gas, we are not going
to be able to meet this growth. We're growing something like 2
to 2.3 percent in the greater Chicago area. We have similar
growths in the greater Philadelphia area. We have to add these
sources in order to meet that load.
We are also faced with the fact that a lot of the coal
plants are very, very old, and so these plants are going to
have to be refurbished.
So there's only three games in town, and you cannot get
there any other way, but we'll be happy to give you something
on the record about that.
Senator Voinovich. Thank you.
Mr. Colvin. Senator, I'd be happy to provide some of that
input, also. I would just give you one data point from last
year's electricity generation. The total amount--as much as we
need solar and wind energy, and we ought to move forward in
that direction--and we clearly support that--the reality is
that they generated less than .1 percent of the total
generation in the United States.
To put that in perspective, the total amount of wind and
solar in the United States last year was the equivalent of the
electricity needed to operate three New York City subway
systems. I mean, that's the amount of electricity that we're
talking about as this demand is growing, so we have to look at
it realistically.
I agree with Mr. Kingsley's comments that we really have to
put our focus on our proven sources of electricity to meet the
economic growth to support our economy.
Senator Voinovich. Senator Carper has joined us. Senator
Carper, would you like to make a statement or ask a question?
We're glad you are here.
OPENING STATEMENT OF HON. THOMAS R. CARPER,
U.S. SENATOR FROM THE STATE OF DELAWARE
Senator Carper. Thanks so much. I'm delighted to be here,
and I welcome all of the witnesses. It is nice to see you, each
of you, and we appreciate your sharing your time and your
thoughts with us.
I've mentioned to some of our colleagues earlier this year
I took a bunch of Boy Scouts from Troop 67 just north of
Wilmington, Delaware--my sons are in that troop--and we went
down to the Norfolk Naval Station--being an old Navy guy--took
them down for a weekend, slept in the sailor's barracks and ate
in the galley and then we went and visited ships and
submarines.
One of the ships we visited was the U.S.S. Teddy Roosevelt,
a nuclear-powered carrier, about 1,000 feet long and 25 stories
high, and it carries about 70 aircraft when they're underway,
about 5,000 men and women when they are underway with the air
wing aboard.
For me, most interesting of all, it needs to stop to refuel
once every 25 years--once every 25 years.
Now, I actually raised this and shared this with my
colleagues at a Democratic caucus we had back in February or
March, and I said, ``You know, we really can't foreclose--as we
consider alternative forms of energy, we can't foreclose the
need to find more efficient, more effective, safer ways to
create nuclear power.'' I thought a few of my colleagues
immediately labeled me with a new nickname, ``Radioactive.''
Some of the kinder ones, by the way. God knows what the others
are saying.
[Laughter.]
Senator Carper. But I simply feel that there is some
potential here, and I think there's potential for creating
nuclear power in ways that are safer.
One of the big issues we hear about, citing nobody wants to
have a nuclear power plant close to their home, or relatively
few people do. We hear about what do we do with the waste, what
do we do with the waste. And I just want us to focus on what do
we do with the waste, and in terms of recent research that you
may have addressed in your testimony that, I'll be honest, I
just haven't read, or with respect to what's going on in other
countries.
If nuclear power is going to play a somewhat greater role
in our future to help us meet our energy needs, what do we do
with the waste? And whoever on this panel would like to help me
with that, I'd welcome your thoughts.
Senator Voinovich. Senator, we'll have them to give a
summary. We spent about the last 20 minutes talking about----
Senator Carper. What do we do with the waste. Yes.
Senator Voinovich. Why don't you bring--why don't you
summarize it where we're at real quickly.
Senator Carper. Crystalize it for me. There's a good word.
Crystalize it for me--not the waste, but your answer.
Mr. Colvin. Crystalize. Yes, sir. Just quickly, we are--the
United States made the decision to use a once-through fuel
process and ultimately put the waste byproducts, the spent
fuel, used fuel from the nuclear power plants in a deep
geologic repository, went through a number of citing processes,
evaluated that, ultimately chose to evaluate the single site
that's at Yucca Mountain, Nevada. That has been being
characterized with a lot of science and engineering, and, as I
talked about all the ``ologies''--hydrology, meteorology,
geology, and so on--and evaluated, and that is now waiting to a
suitability decision--recommendation, I should say, by the
Secretary of Energy to the President some time probably in the
latter part of this year.
That will then trigger some policy and procedural issues as
regards to the rights of the State of Nevada, and ultimately
that issue will likely come back to both the House and the
Senate for a simple majority vote to either sustain the veto of
Nevada or override that veto and go forward with Yucca
Mountain.
If you put that program in place and we move to that point,
though, it will likely be an additional 8 to 15 years before
that repository goes into full operation and starts actually
moving fuel to be emplaced in that repository. It will likely
operate for between 100 and 300 years before the decision is
ultimately made to close that mountain up and leave it for
generations of the future.
Senator Carper. Anybody else? Anybody on recycling? In
terms of new technologies, my understanding of Yucca Mountain
is basically we store it there until we fill it up, and then we
stop storing it there, or we would.
Mr. Colvin. Well, ultimately, whether we use--whether we
recycle a fuel or whether we use a once-through fuel cycle,
ultimately, whatever waste is left over you have to put in some
deep geologic repository, and that's the program that each
country is looking at, whether it's France or Japan or the
United States. The question is whether you do a once-through
process or do you recycle it.
President Carter, in 1978, through a policy decision, our
Government made the decision we would not recycle, and we're
going down that path. Today to change that would be hugely
costly without a lot of gain--were the Nation accepting,
perhaps the size of what ultimately goes into Yucca Mountain or
whatever repository.
But, just to give you a size consideration, all the fuel
from all our Nation's 103 plants operating after 40 years would
fill a football field 10 yards deep. We're not talking about a
huge volume of waste, as compared to other types of waste
products or byproducts that we have to dispose of.
Senator Carper. Say that again?
Mr. Colvin. It's about one football field 10 yards deep
would take all the waste from the Nation's 103 nuclear power
plants operating over 40 years.
Senator Carper. All right. Thank you.
Anybody else?
[No response.]
Senator Carper. Mr. Chairman, thank you very much.
Senator Voinovich. Thank you.
We thank the panel for your patience, and apologize for the
long delay. It's very embarrassing to me, but that's the way
the Senate operates.
Mr. Colvin. It's not your fault.
Senator Voinovich. Yes, but I just want all of you to know
how grateful I am for your patience and your being here today.
Some of you have come from out of State to be here. Thank you
so much for being here. We appreciate it.
[Whereupon, at 12:43 p.m., the subcommittee was adjourned,
to reconvene at the call of the chair.]
[Additional statements submitted for the record follows:]
Statement of Hon. Richard A. Meserve, Chairman,
Nuclear Regulatory Commission
introduction
Mr. Chairman, members of the Subcommittee, it is a pleasure to
appear before you today with my fellow Commissioners. I would like to
take this opportunity to acknowledge the strong support this
Subcommittee provided in the 106th Congress in enacting legislation
which addresses the long-standing fairness in funding issue. We also
appreciate the Subcommittee's and full Committee's efforts in support
of the Nuclear Regulatory Commission's (NRC's) other legislative
proposals in the 106th Congress, most of which were included in S. 1627
which passed the Senate. We look forward to working constructively with
you in the new Congress.
As you know, the NRC's mission is to ensure the adequate protection
of public health and safety, the common defense and security, and the
environment in the application of nuclear technology for civilian use.
The Commission does not have a promotional role--rather, the agency
seeks to ensure the safe application of nuclear technology if society
elects to pursue the nuclear energy option.
The Commission recognizes, however, that its regulatory system
should not establish inappropriate impediments to the application of
nuclear technology. Many of the Commission's initiatives over the past
several years have sought to maintain or enhance safety while
simultaneously improving the efficiency and effectiveness of our
regulatory system. We believe the Commission's most recent legislative
proposals would enhance safety and improve our regulatory system even
further and are pleased to see that many of our proposals have been
incorporated into the bills before this Congress. The Commission also
recognizes that its decisions and actions as a regulator influence the
public's perception of the NRC and ultimately the public's perception
of the safety of nuclear technology. For this reason, the Commission's
primary performance goals also include increasing public confidence.
background
Currently there are 104 nuclear power plants licensed by the
Commission to operate in the United States in 31 different States. As a
group, they are operating at high levels of safety and reliability.
(See Charts on Attachments 1 and 2.)
These plants have produced approximately 20 percent of our nation's
electricity for the past several years and are operated by about 40
different companies. In 2000, these nuclear power plants produced a
record 755 thousand gigawatt-hours of electricity. (See Graph on
Attachment 3.)
Improved Licensee Efficiencies (Increased Capacity Factors)
The Nation's nuclear electricity generators have worked over the
past 10 years to improve nuclear power plant performance, reliability,
and efficiency. According to the Nuclear Energy Institute, the improved
performance of the U.S. nuclear power plants since 1990 is equivalent
to placing 23 new 1000 MWe power plants on line. The average capacity
factor for U.S. light water reactors was 88 percent in 2000, up from 63
percent in 1989.\1\ (See Table on Attachment 3.) The Commission has
focused on ensuring that safety is not compromised as a result of these
industry efforts. The Commission seeks to carry out its regulatory
responsibilities in an effective and efficient manner so as not to
impede industry initiatives inappropriately.
---------------------------------------------------------------------------
\1\ Capacity factor is the ratio of electricity generated, for the
period of time considered, to the amount of energy that could have been
generated at continuous full-power operation during the same period.
---------------------------------------------------------------------------
Electric Industry Restructuring
As you are aware, the nuclear industry is undergoing a period of
remarkable change. The industry is in a period of transition in several
dimensions, probably experiencing more rapid change than in any other
period in the history of civilian nuclear power. As deregulation of
electricity generation proceeds, the Commission is seeing significant
restructuring among the licensees and the start of the consolidation of
nuclear generating capacity among a smaller group of operating
companies. This change is due, in part, to an industry that has
achieved gains in both economic and safety performance over the past
decade and thus is able to take advantage of the opportunities
presented by industry restructuring.
initiatives in the area of current reactor and materials regulation
License Transfers
One of the more immediate results of the economic deregulation of
the electric power industry has been the development of a market for
nuclear power plants as capital assets. As a result, the Commission has
seen a significant increase in the number of requests for approval of
license transfers. These requests have increased from a historical
average of about two or three per year, to 20-25 in the past 2 years.
The Commission seeks to ensure that our reviews of license transfer
applications, which focus on adequate protection of public health and
safety, are conducted efficiently. These reviews sometimes require a
significant expenditure of staff resources to ensure a high quality and
timely result. Our legislative proposal to eliminate foreign ownership
review could help to further streamline the process. To date, the
Commission believes that it has been timely in these transfers. For
example, in CY 2000, the staff reviewed and approved transfers in
periods ranging from four to 8 months, depending on the complexity of
the applications. The Commission will strive to continue to perform at
this level of proficiency even in the face of continued demand.
License Renewals
Another result of the new economic conditions is an increasing
interest in license renewal that would allow plants to operate beyond
the original 40-year term. That maximum original operating term, which
for many plants were established in the Atomic Energy Act (AEA), did
not reflect a limitation that was determined by engineering or
scientific considerations, but rather was based on financial and
antitrust concerns. The Commission now has the technical bases and
experience on which to make judgments about the potential useful life
and safe operation of facilities and is addressing the question of
extensions beyond the original 40-year term.
The focus of the Commission's review of applications is on
maintaining plant safety, with the primary concern directed at the
effects of aging on important systems, structures, and components.
Applicants must demonstrate that they have identified and can manage
the effects of aging so as to maintain an acceptable level of safety
during the period of extended operation.
The Commission has now renewed the licenses of plants at two sites
for an additional 20 years: Calvert Cliffs in Maryland, and Oconee in
South Carolina, comprising a total of five units. The thorough reviews
of these applications were completed ahead of schedule, which is
indicative of the care exercised by licensees in the preparation of the
applications and the planning and dedication of the Commission staff.
Applications for units from three additional sites--Hatch in Georgia,
ANO-1 in Arkansas, and Turkey Point in Florida--are currently under
review. As indicated by our licensees, many more applications for
renewal are anticipated in the coming years.
Although the Commission has met or exceeded the projected schedules
for the first reviews, it would like the renewal process to become as
effective and efficient as possible. The extent to which the Commission
is able to sustain or improve on our performance depends on the rate at
which applications are actually received, the quality of the
applications, and the staff resources available to complete the review
effort. The Commission recognizes the importance of license renewal and
is committed to providing high-priority attention to this effort. As
you know, the Commission encourages early notification by licensees of
their intent to submit license renewal applications in order to allow
adequate planning of demands on staff resources. The Commission is
committed to maintaining the quality of its safety reviews.
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Reactor Plant Power Uprates
In recent years, the Commission has approved numerous license
amendments that permit licensees to make relatively small power
increases or uprates. Typically, these increases have been
approximately 2 percent to 7 percent. These uprates, in the aggregate,
resulted in adding approximately 2000 MWe or two new 1000 MWe power
plants.
The NRC is now reviewing five license amendment requests for larger
power uprates. These requests are for Boiling Water Reactors (BWR's)
and are for uprates of 15 percent to 20 percent. (There are two primary
designs for operating light water reactors: Boiling Water Reactors and
Pressurized Water Reactors.) While the staff has not received requests
for additional uprates beyond these five, some estimates indicate that
as many as 22 BWR'S may request uprates in the 15 percent to 20 percent
range. These uprates, if allowed, could add approximately 3,000 to
4,500 MWe to the grid.
Approvals for uprates are granted only after a thorough evaluation
by NRC staff to ensure safe operation of the plants at the higher
power. Plant changes and modifications are necessary to support a large
power uprate, and thus require significant financial investment by the
licensee. While the NRC does not know the number of uprate requests
that will be received, the staff is evaluating ways to streamline the
review and approval process. As with license renewals, the Commission
encourages early notification by licensees, in advance of their
applications for uprates, in order to allow adequate planning of
demands on staff resources.
Nuclear Materials Program
I also want to highlight our nuclear materials program for you. We
have a very large number of materials-related initiatives underway. As
with our reactor program, we are working on making our nuclear
materials regulation more risk-informed and flexible. For example, we
are in the final steps of totally revising our regulations governing
the medical use of byproduct material using risk insights, together
with other factors, to establish requirements that better focus
licensee and regulatory attention on issues commensurate with their
importance to health and safety. We are also revising our regulations
governing the licensing of fuel cycle facilities to introduce the use
of an integrated safety assessment, thereby incorporating risk insights
into the regulation of these facilities. We are also working with the
international community to learn about problems associated with
facilities and materials programs abroad, most recently illustrated by
events in Japan and Thailand.
We are currently reviewing the Construction Application Request for
a mixed-oxide fuel fabrication facility at the Department of Energy's
(DOE's) Savannah River site in South Carolina. In coordination with
that effort, we also are conducting scoping meetings with stakeholders
for the development of the Environmental Impact Statement to support
NRC's licensing reviews of a MOX facility.
We continue to decommission various complex materials sites around
the country. We are working to finalize our policy statement on the
cleanup criteria to be applied at DOE's West Valley site in New York
and we continue to provide technical assistance to DOE on related
technical matters, including cleanup of the high-level waste tanks at
the Savannah River site.
We are also revising our requirements for the transportation of
spent fuel and radioactive material to make them more risk-informed and
consistent with international standards. We are doing this in
partnership with the Department of Transportation, which will
simultaneously revise its own rule in this area. Finally, we are
working to address the complex issues associated with regulating the
uranium recovery industry at a time when uranium prices remain at
historic lows. Let me now move on to the storage and disposal of high-
level waste and spent fuel.
High-Level Waste Storage/Disposal (Spent Fuel Storage)
In the past several years, the Commission has responded to numerous
requests to approve spent fuel cask designs and independent spent fuel
storage installations for onsite dry storage of spent fuel. These
actions have provided an interim approach pending implementation of a
program for the long-term disposition of spent fuel. The ability of the
Commission to review and approve these requests has provided the needed
additional onsite storage of spent nuclear fuel, thereby avoiding plant
shutdowns as spent fuel pools reach their capacity. The Commission
anticipates that the current lack of a final disposal site will result
in a large increase in onsite dry storage capacity during this decade.
The Commission is currently reviewing an application for an
Independent Spent Fuel Storage Installation on the reservation of the
Skull Valley Band of Goshute Indians in Utah.
Certain matters also need to be resolved in order to make progress
on a deep geologic repository for disposal of spent nuclear fuel. The
Energy Policy Act of 1992 requires the Environmental Protection Agency
(EPA) to promulgate general standards to govern the site, while the
Commission has the obligation to implement those standards through its
licensing and regulatory process. The Commission has concerns about
certain aspects of EPA's proposed approach and is working with EPA to
resolve these issues. Some of our legislative proposals would eliminate
these issues.
We continue to prepare for a potential license application from DOE
for the proposed high-level waste geologic repository at Yucca
Mountain. These efforts include periodic technical exchange meetings
between NRC and DOE staff which are open to the public.
Risk--Informing the Commission's Regulatory Framework
The Commission also is in a period of dynamic change as the agency
moves from a prescriptive, deterministic approach toward a more risk-
informed and performance-based regulatory paradigm. Improved
probabilistic risk assessment techniques combined with more than four
decades of accumulated experience with operating nuclear power reactors
has led the Commission to recognize that some regulations may not serve
their intended safety purpose and may not be necessary to provide
adequate protection of public health and safety. Where that is the
case, the Commission has determined it should revise or eliminate the
requirements. On the other hand, the Commission is prepared to
strengthen our regulatory system where risk considerations reveal the
need.
Perhaps the most visible aspect of the Commission's efforts to
risk-inform its regulatory framework is the new reactor oversight
process. The process was initiated on a pilot basis in 1999 and fully
implemented in April 2000. The new process was developed to focus
inspection effort on those areas involving greater risk to the plant
and thus to workers and the public, while simultaneously providing a
more objective and transparent process. Although the Commission
continues to work with its stakeholders to assess the effectiveness of
the revised oversight process, the feedback received from industry and
the public is favorable.
future activities
Scheduling and Organizational Assumptions Associated with New Reactor
Designs
While improved performance of operating nuclear power plants has
resulted in significant increases in electrical output, significant
increased demands for electricity will need to be addressed by
construction of new generating capacity of some type. Serious industry
interest in new construction of nuclear power plants in the United
States has only recently emerged. As you know, the Commission has
already certified three new reactor designs pursuant to 10 CFR Part 52.
These designs include General Electric's advanced boiling water
reactor, Westinghouse's AP-600 and Combustion Engineering's System 80+.
Because the Commission has certified these designs, a new plant order
may include one of these approved designs. However, the staff is also
conducting a preliminary review associated with other new designs.
Licensees have also indicated to the NRC that applications for early
site permits could be submitted in the near future. These permits would
allow pre-certification of sites for possible construction of nuclear
power plants.
In addition to the three already certified advanced reactor
designs, there are new nuclear power plant technologies, such as the
Pebble Bed Modular Reactor, which some believe can provide enhanced
safety, improved efficiency, and lower costs, as well as other
benefits. To ensure that the Commission staff is prepared to evaluate
any applications to introduce these advanced nuclear reactors, the
Commission recently directed the staff to assess the technical,
licensing, and inspection capabilities that would be necessary to
review an application for an early site permit, a license application,
or construction permit for a new reactor unit. This will include the
capability to review the designs for Generation III+ or Generation IV
light water reactors, including the Westinghouse AP-1000, the Pebble
Bed Modular Reactor, General Atomics' Gas Turbine Modular Helium
Reactor, and the International Reactor Innovative and Secure (IRIS)
designs. In addition to assessing its capability to review the new
designs, the Commission will also examine its regulations relating to
license applications, such as 10 CFR Parts 50 and 52, in order to
identify whether any enhancements are necessary. We also recently
established the Future Licensing Project Organization in order to
prepare for and manage future reactor and site licensing applications.
In order to confirm the safety of new reactor designs and
technology, the Commission believes that a strong nuclear research
program should be maintained. A comprehensive evaluation of the
Commission's research program is underway with assistance from a group
of outside experts and from the Advisory Committee on Reactor
Safeguards. With the benefit of these insights, the Commission expects
to undertake measures to strengthen our research program over the
coming months.
Human Capital
Linked to these technical and regulatory assessments, the
Commission is reviewing its human capital to ensure that the
appropriate professional staff is available for the Commission to
fulfill its traditional safety mission, as well as any new regulatory
responsibilities in the area of licensing new reactor designs.
In some mission critical offices within the Commission, nearly 25
percent of the staff are eligible to retire today. In fact, the
Commission has six times as many staff over the age of 60 as it has
staff under 30.
And, as with many Federal agencies, it is becoming increasingly
difficult for the Commission to hire personnel with the knowledge,
skills, and abilities to conduct the safety reviews, licensing,
research, and oversight actions that are essential to our safety
mission. Moreover, the number of individuals with the technical skills
critical to the achievement of the Commission's safety mission is
rapidly declining in the Nation, and the educational system is not
replacing them. The Commission's staff has taken initial steps to
address this situation, and as a result, is now seeking systematically
to identify future staffing needs and to develop strategies to address
the gaps. It is apparent, however, that the maintenance of a
technically competent staff will require substantial effort for an
extended time. The various Senate energy bills properly give attention
to such matters. The Commission would be pleased to offer some further
suggestions in the same vein.
Budget
The NRC is proposing a fiscal year 2002 budget of $513.1 million.
This represents approximately a 5.3 percent ($25.8 million) increase
over the fiscal year 2001 budget. Our budget proposal will allow the
NRC to continue adequately to protect the public health and safety,
promote the common defense and security, and protect the environment,
while providing sufficient resources to address increasing personnel
costs and increasing workloads. Approximately 60 percent of the budget
growth is for increasing personnel costs, primarily the pay raise that
the President has authorized for Federal employees. The remaining
increase is required for several purposes: to continue preparing for
the review of a potential Department of Energy application to build a
high-level radioactive waste geologic repository; to review four
additional reactor license renewal applications; to develop
environmental assessments for decommissioning or terminated license
requests; to sustain important reactor and waste safety research; and
to pay for increased operating costs associated with rent and transit
subsidies. At the same time, the number of employees at the agency
continues to reflect almost a 20 percent reduction in staff since
fiscal year 1993. Two charts reflecting a summary of our budget since
fiscal year 1993 are Attachments 4 and 5 to this testimony.
The NRC recently submitted a proposed bill for authorization of
appropriations for fiscal year 2002. We respectfully request the
Committee's support for our budget request. However, as I mentioned
earlier, serious industry interest in new construction of nuclear power
plants has only recently emerged. Therefore, our budget proposal does
not include resources to prepare for this initiative.
legislative proposals
The Commission has identified in its legislative proposals areas
where new legislation would be helpful to eliminate artificial
restrictions and to reduce the uncertainty in the licensing process.
These changes would maintain safety while increasing flexibility in
decisionmaking. Although those changes would have little or no
immediate impact on electrical supply, they would help establish the
context for consideration of nuclear power by the private sector
without any compromise of public health and safety or protection of the
environment.
Legislation will be needed to extend the Price-Anderson Act. The
Act, which expires on August 1, 2002, establishes a framework that
provides assurance that adequate funds are available in the event of a
nuclear accident and sets out the process for consideration of nuclear
claims. Without the framework provided by the Act, private-sector
participation in nuclear power would be discouraged by the risk of
large liabilities.
Reorganization Plan No. 3 of 1970 could be revised to provide the
Commission with the sole responsibility to establish all generally
applicable standards related to Atomic Energy Act (AEA) materials,
thereby avoiding dual regulation of such matters by other agencies.
Along these same lines, the Nuclear Waste Policy Act of 1982 could be
amended to provide the Commission with the sole authority to establish
standards for high-level radioactive waste disposal. These changes
would serve to provide full protection of public health and safety,
provide consistency, and avoid needless and duplicative regulatory
burden.
Commission antitrust reviews of new reactor licenses could also be
eliminated. As a result of the growth of Federal antitrust law since
the passage of the AEA, the Commission's antitrust reviews are
redundant of the reviews of other agencies. The requirement for
Commission review of such matters, which are distant from the
Commission's central expertise, should be eliminated.
Elimination of the ban on foreign ownership of U.S. nuclear plants
would be an enhancement since many of the entities that are involved in
electrical generation have foreign participants, thereby making the ban
on foreign ownership increasingly problematic. The Commission has
authority to deny a license that would be inimical to the common
defense and security, and thus an outright ban on all foreign ownership
is unnecessary.
With the strong congressional interest in examining energy policy,
the Commission is optimistic that there will be a legislative vehicle
for making these changes and thereby for updating the AEA. Indeed, we
note that certain of these matters are included in bills now before
this Committee.
summary
The Commission has long been, and will continue to be, active in
concentrating its staffs' efforts on ensuring the adequate protection
of public health and safety, the common defense and security, and the
environment in the application of nuclear technology for civilian use.
Those statutory mandates notwithstanding, the Commission is mindful of
the need: (1) to reduce unnecessary burdens, so as not to
inappropriately inhibit any renewed interest in nuclear power; (2) to
maintain open communications with all of its stakeholders, in order to
seek to ensure the full, fair, and timely consideration of issues that
are brought to our attention; and (3) to continue to encourage its
highly qualified staff to strive for increased efficiency and
effectiveness, both internally and in our dealings with all of the
Commission's stakeholders.
Thank you Mr. Chairman, I welcome your comments and questions.
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Responses by Richard Meserve to Additional Questions from Senator Reid
Question 1. How many currently licensed nuclear power plants have
foreign ownership?
Response. Three power reactors, Three Mile Island, Unit 1, Clinton,
and Oyster Creek, are owned by AmerGen. British Energy, Inc., a foreign
company, indirectly owns 50 percent of AmerGen, and thus is an indirect
owner of these plants. In addition, New England Power owns about 10
percent of the Seabrook plant and about 12 percent of Millstone, Unit
3. New England Power is an indirect wholly-owned subsidiary of the
National Grid Group, a British company. However, Millstone 3, including
New England Power's share, is being sold to a U.S. company and Seabrook
is also beginning the sale process.
In a few instances, a small percentage of stock in U.S. companies
that own nuclear power plants may be held by foreign individuals or
entities. In order to ensure, in part, that power reactor licensees
inform the NRC of such situations, the NRC issued Regulatory Issue
Summary (RIS) 2000-01 on February 1, 2000. This RIS reminded power
reactor licensees of their obligation to inform the NRC when changes
occur with respect to foreign ownership, control, or domination in ways
that include, but are not limited to the following: (1) a license
holder becomes aware of changes in foreign ownership or control of its
company or of its parent company, for example, by receiving Securities
and Exchange Commission Schedules 13D or 13G indicating such changes;
(2) a license holder, or its parent company, plans to merge with or be
acquired by an entity that is owned, controlled, or dominated by
foreign interests; or (3) a license holder's Board of Directors becomes
controlled or dominated by board members who are not U.S. citizens.
Question 2. How many of the principal nuclear power engineering,
maintenance, and equipment supply companies have significant foreign
investment?
Response. This question goes to the heart of why we believe that
the foreign ownership prohibitions on utilization facilities (i.e.,
commercial and research reactors) in Sections 103d and 104d of the
Atomic Energy Act should be eliminated. The current prohibitions apply
only to utilization and production facilities, not to the enterprises
listed in the question. (A separate foreign ownership prohibition in
Section 193(f) applies to the United States Enrichment Corporation. The
Commission is not proposing to eliminate that prohibition or the
prohibition on production facilities in Sections 103d and 104d.)
Many enterprises--arguably more sensitive than nuclear reactors
from a common defense and security prospective--have long had
significant foreign ownership, primarily from Europe and Japan. The
vendors of three of the four reactor designs currently deployed in our
104 licensed reactors--Westinghouse, Combustion Engineering, and
Babcock and Wilcox--are foreign-owned. Only General Electric is
American-owned. The vendor of two of the three currently NRC certified
advanced reactor designs is foreign. The Pebble Bed Modular Reactor
design team is South African-based, with a U.S. firm--Exelon--having a
minority interest. Other advanced reactor designs are likely to be
international as well.
Similarly, six of the seven major fuel cycle facilities currently
licensed by NRC have significant or total foreign ownership. Only
Nuclear Fuel Services, Inc., one of the two category 1 fuel cycle
facilities which handles highly enriched uranium (HEU), is entirely
U.S. owned by a U.S. corporation. The other category 1 fuel cycle
facility--BWX Technologies, Inc.--is owned by McDermott International,
Inc., a Panama corporation which is a publicly traded company on the
New York Stock Exchange. In that case, consistent with the statutory
requirement to ensure common defense and security, the Commission in
consultation with the Department of Energy (DOE) required a variety of
mitigating measures, such as an oversight board comprised wholly of
U.S. members. The only new fuel cycle facility currently planned, the
mixed oxide fuel facility to be built at the DOE Savannah River, South
Carolina site to carry out the DOE weapons plutonium disposition
mission, will also have significant foreign involvement.
The Commission believes that the common defense and security
provisions in Sections 103d and 104d of the Atomic Energy Act are
sufficient to ensure that any foreign ownership of a U.S. utilization
facility will not be inimical to U.S. security, just as similar
provisions elsewhere in the Atomic Energy Act have ensured that other
arguably more sensitive facilities and enterprises do not have
unacceptable foreign owners. The foreign ownership restrictions on
nuclear power plants are out of date because the nuclear industry, like
most high technology industries, has for some time been an
international enterprise. The categories of reactor vendors,
construction firms, fuel cycle facilities, spent fuel cask
manufacturers, and reactor component manufacturers all have significant
foreign ownership. Commercial nuclear power plants should, in our view,
be treated similarly.
Question 3. The Administration has indicated a concern with our
dependence on foreign energy supplies. Do you think we should allow
significant control over our nuclear power supply?
Response. We understand that the Administration's concerns with
dependence on foreign energy supply relates primarily to fuels, such as
petroleum, that are imported from foreign nations, and that might
present an economic or national-security threat if interrupted. As
noted in response to the previous question, the Commission is not
proposing to eliminate either the foreign ownership restriction for
production facilities (enrichment or reprocessing facilities) or the
separate foreign ownership prohibition in Section 193(f) that applies
to the United States Enrichment Corporation. The Commission believes
that these foreign ownership restrictions on more sensitive facilities
still serve the purpose that motivated their adoption.
The Commission submitted proposed legislation to Congress that
would amend Sections 103d and 104d of the Atomic Energy Act of 1954, as
amended (AEA), by removing the prohibition against foreign ownership,
control, or domination of utilization facilities (which include both
power and research and test reactors). It is the Commission's
understanding that Congress has not restricted foreign ownership of
other sources of domestic energy supply. A per se prohibition against
foreign ownership of utilization facilities, which originated in the
1954 enactment of the AEA at a time when commercial development of
nuclear power was in its incipient stages, is outdated and unnecessary.
The Commission believes that significant foreign ownership within the
U.S. nuclear power industry could be allowed without adversely
affecting common defense and security. The general non-inimicality
restriction contained in Sections 103d and 104d provides ample
authority for the Commission to refuse to issue a license or take other
actions in cases where foreign ownership would be inconsistent with the
national defense and security or other policies of the United States.
Question 4. Did the NRC conduct an analysis of the subsidy the
Price-Anderson Act provides the nuclear industry? If so, what did the
NRC determine the subsidy to be?
Response. The NRC has not analyzed ``the subsidy issue'' since its
December 1983 Report to Congress. See the Price-Anderson Act--The Third
Decade (NUREG-0957). As a result of the 1988 Price-Anderson Act
Amendments, the observation ``a subsidy may exist'' had become obsolete
or at the least a tenuous conclusion. To date, no Federal government
funds have been paid out as a result of damage claims under Price-
Anderson Act against licensed nuclear facilities.
Before the 1988 modifications to the Act and pursuant to the 1975
Price-Anderson amendments, enacted as P.L. 94-197, each licensee of a
power reactor with a capacity of 100,000 kilowatts electric or more was
required to contribute to a retrospective premium pool. The
contribution, then a one time contribution of $5 million, was called
for only in the event that public liability as a result of an accident
exceeded the commercial insurance coverage. That first layer of
protection was, and remains, by statutory requirement, the maximum
commercial insurance available at a reasonable price. Originally,
government indemnification came into play immediately after the
insurance layer was exhausted. The government commitment was to be
sufficient to achieve a total of $560 million per reactor per accident,
which was also the limit of liability. At that time $60 million was
available as insurance. The 1975 amendments introduced the industry
retrospective premium pool which delayed the time and lessened the
amount of government exposure. In 1982, as a result of additional
reactors added to the pool, government exposure was eliminated
entirely, unless by some unexpected event the size of the pool were to
diminish so that some government contribution would again be possible.
The 1988 amendments significantly increased the size of the
retrospective premium owed by each reactor licensee to $63 million to
be adjusted regularly for inflation. This premium is now, as adjusted,
$83.9 million. This brings the available funds in the event of an
accident to over $9 billion, effectively eliminating any reasonable
likelihood of dropping below the $560 million mark at which the Federal
government would become exposed. Thus, under current law the totality
of funds for compensation of public liability up to the allowable limit
is payable by direct insurance of the facility owner or the
retrospective premium pool. This supports the conclusion that there is
no direct subsidy in the Price-Anderson scheme.
The Price-Anderson Act contains a Congressional commitment to
provide the means for prompt and full compensation if the sum of
liabilities exceeds the limit on liability and the available funds, now
over $9 billion. However, the statutory language notes expressly that
the limitation of liability provision may not be construed to preclude
the Congress from raising the funds by enacting a revenue measure
applicable to NRC licensees maintaining financial protection under
Section 170b (i.e., the commercial nuclear power reactors).
We believe that the 1988 Amendments also extinguished or lessened
any cause to consider the limitation on liability to be a subsidy. To
be a subsidy, the grant or other form of encouragement must be one-way,
i.e., without equivalent compensation. Such is not the case here. Even
when the liability limit was only $560 million, the United States
Supreme Court found that Price-Anderson ``does, in our view, provide a
reasonable just substitute for the common-law or State tort law
remedies it replaces.'' Duke Power Co. v. Carolina Env. Study Group,
438 U.S. 59,88 (1978). The Court found that benefits to the public
provided a quid pro quo for the liability limit and firmly rejected the
argument that ``no quid pro quo can be provided by the Act since
without it there would be no nuclear power plants and no possibility of
accidents or injuries.'' Id at n. 33 and related text.
Today the Act serves the public by ensuring the availability of
over $9 billion to cover injuries sustained to person or property.
Moreover, the licensees must waive various defenses and the industry
insurance and premium pool must pay out no matter who or what caused
the accident. These provisions may give greater assurance of
compensation than exists under other compensation schemes. The public
gains these advantages without cost to the government.
Question 5a. In 1999, the NRC implemented a 1985 rule to limit the
types of meetings that would be held in accordance with the Sunshine
Act. How many meetings has the NRC held since this new rule went into
effect that would have been subject to the Sunshine Act's requirements,
but are no longer?
Response. The NRC has held four Non-Sunshine Act Discussions since
the 1985 rule was implemented in 1999.
Question 5b. What was the nature of these meetings? Who
participated? What topics were discussed?
Response. September 15, 1999; 3:02 p.m.
Topic discussed: Information briefing on hurricane (Floyd)
preparedness activities.
Commissioners present: Chairman Dicus, Commissioner Diaz,
Commissioner McGaffigan, and Commissioner Merrifield.
Staff present: Beall, J., Assistant to Commissioner McGaffigan;
Castleman, P., Assistant to Commissioner Diaz; Chan, T., Assistant to
Chairman Dicus; Congel, F., Incident Response Operations Office; Cyr,
K., General Counsel; Dyer, J., Region III; Hart, K., Office of the
Secretary; Hasselberg, R., Incident Response Operations Office; Hiltz,
T., Assistant to Chairman Dicus; Jones, B., Assistant to r Chairman
Dicus; McCabe, B., Assistant to Commissioner Merrifield; Rathbun, D.,
Office of Congressional Affairs; Shea, J., Assistant to Commissioner
Merrifield; Smith, G., Office of the Executive Director for Operations;
Thoma, J., Assistant to Commissioner Merrifield; Vietti-Cook, A.,
Office of the Secretary; and Wert, L., Office of the Executive Director
for Operations.
September 22, 1999, 1:05 p.m.
Topic discussed: Media Streaming
Commissioners present: Commissioner Diaz, Commissioner McGaffigan,
and Commissioner Merrifield
Staff present: Cloud, J., Office of the Chief Information Officer;
Crockett, S., Assistant to Commissioner McGaffigan; Cyr, K., General
Counsel; Davis, R., Assistant to Commissioner Diaz; Funches, J., Chief
Financial Officer; Goldberg, F., Office of the Chief Information
Officer; Greene, K., Office of the Executive Director for Operations;
Hart, K., Office of the Secretary; Kirk, I., Office of the Chief
Information Officer; Marcy, C., Office of the Chief Information
Officer; Marcy, C., Office of Administration; Miraglia, F., Deputy
Executive Director for Reactor Programs; Pulliam, T., Office of the
Chief Financial Officer; Reiter, S., Acting Chief Information Officer;
Schaeffer, J., Office of the Chief Information Officer; Scheffler, T.,
Office of the Chief Information Officer; Springer, M., Office of
Administration; Travers, W., Executive Director for Operations; Vietti-
Cook, A., Secretary of the Commission; Wilson, V., Office of
Administration
February 18, 2000, 2:00 p.m.
Topic discussed: Indian Point Unit 2 Steam Generator Tube Leak
Event Briefing
Commissioners present: Chairman Meserve, Commissioner Dicus,
Commissioner Diaz, Commissioner McGaffigan, and Commissioner Merrifield
Staff present: Beall, J., Assistant to Commissioner McGaffigan;
Benner, E., Office of Nuclear Reactor Regulation; Black, S., Office of
Nuclear Reactor Regulation; Castleman, P., Assistant to Commissioner
Diaz; Chan, T., Assistant to Chairman Meserve, Chandler, L., Office of
the General Counsel; Clifford, J., Office of Nuclear Reactor
Regulation; Collins, S., Office of Nuclear Reactor Regulation;
Crockett, S., Assistant to Commissioner McGaffigan; Cyr, K., General
Counsel; Gray, J., Office of the General Counsel; Harold, J., Office of
Nuclear Reactor Regulation; Hayden, E., Office of Public Affairs; Hill
W., Office of the Secretary; Hiltz, T., Assistant to Commissioner
Dicus; Levin, A., Assistant to Chairman Meserve; Marsh, L., Office of
Nuclear Reactor Regulation; McCabe, B., Assistant to Commissioner
Merrifield; Miller, H., Region I (via telehone); Murphy, E., Office of
Nuclear Reactor Regulation; Portner, L., Office of Congressional
Affairs; Rubin, A., Office of Nuclear Regulatory Research; Shea, J.,
Office of the Executive Director for Operations; Tracy, G., Assistant
to Chairman Meserve; Travers, W., Office of the Executive Director for
Operations; Tschiltz, M., Office of the Executive Director for
Operations; Vietti-Cook, A., Office of the Secretary; Wessman, R.,
Office of Nuclear Reactor Regulation
March 1, 2000, 10:30 a.m.
Topic discussed: NRC's Y2K Program Lessons Learned Media Streaming
Commissioners present: Commissioner Diaz, Commissioner McGaffigan,
and Commissioner Merrifield
Staff present: Bates, A., Office of the Secretary; Beecher, W.,
Office of Public Affairs; Breskovic, C., Office of International
Programs; Castleman, P., Assistant to Commissioner Diaz; Chan, T.,
Assistant to Chairman Meserve; Chiramal, M., Office of Nuclear Reactor
Regulation; Congel, F., Incident Response Operations Office; Hiltz, T.,
Assistant to Commissioner Discus; Levin, M., Office of the Chief
Information Officer; McCabe, B., Assistant to Commissioner Merrifield;
Miraglia, F., Office of the Executive Director for Operations;
Paperiello, C., Office of the Executive Director for Operations;
Ramsey, J., Office of International Programs; Schaeffer, J., Office of
the Chief Information Office; Sharkey, J., Assistant to Commissioner
McGaffigan; Voglewede, J., Office of the Chief Information Officer
Question 6a. How many of these meetings have involved issues
related to the proposed nuclear waste repository at Yucca Mountain or
the proposed radiation standards from the EPA?
Response. None.
Question 6b. Who participated in these discussions and what was the
nature of them?
Response. N/A
Question 7. I understand the hearing process for possible licensing
activities at Yucca Mountain has retained the formal procedures
relating to witness cross-examination and evidence discovery. I am
encouraged by this decision. Could you explain, however, the reasons
the NRC should move away from a formal process for licensing and
relicensing activities.
Response. The Commission is considering greater use of informal
adjudicatory procedures in order to: (i) conserve parties' and NRC
resources which are expended in hearings, (ii) expedite the conduct of
hearings to ensure timely decisionmaking, consistent with the rights of
all parties, and (iii) enhance the quality of the NRC's adjudicatory
decisions. A proposed rule that would streamline and enhance the NRC's
hearing procedures through greater use of informal adjudicatory
procedures was published in the Federal Register on April 16, 2001 (66
FR 19610).
The Commission believes that in most instances, the use of formal
adjudicatory procedures is not essential to the development of an
adequate hearing record. All too frequently their use has resulted in
protracted, costly proceedings and unfocused hearing records that form
poor bases for adjudicatory decisions. The Commission is not alone in
its assessment of the relative value of formal adjudications. Over the
decades since the Atomic Energy Act was passed, there has been debate
over the value of formal, on-the-record adjudication for the resolution
of nuclear licensing issues, and indeed for resolving scientific issues
generally. There are now many observers who are skeptical that the use
of formal adjudication in NRC licensing cases is the appropriate means
to settle a regulatory issue; that the arguments for formal
adjudication from the 1950s to the 1970s have diminished validity; and
that less formalized proceedings could mean not only greater
efficiency, but also better decisions, with more meaningful public
participation and greater public acceptance of the result. See, e.g.,
Improving Regulation of Safety at DOE Nuclear Facilities, Final Report
of the Advisory Committee on External Regulation of DOE Nuclear Safety,
December 1995, at 39.
The Commission has taken a number of steps in recent years to
reassess its processes to identify ways in which it can conduct its
regulatory activities more effectively. This assessment has extended
across the full range of the NRC's programs, from its oversight and
inspection program to evaluate and assess licensee performance, to its
internal program management activities. The NRC has always sought to
ensure that its review processes and decisionmaking are open,
understandable, and accessible to all interested parties. Recently,
steps have been taken to expand the opportunities for stakeholder
awareness and involvement in NRC policy and decisionmaking through
greater use of public workshops in rulemaking, inviting stakeholder
participation in Commission meetings, and more extensive use of public
meetings with interested parties on a variety of safety and regulatory
matters.
The Commission has had a longstanding concern that the hearing
process associated with licensing and enforcement actions taken by the
NRC is not as effective as it could be. Beginning with case-by-case
actions in 1983, and with a final rule in 1989, the Commission took
steps to move away from the trial-type, adversarial format to resolve
technical disputes with respect to its materials license applications.
A significant portion of the NRC's proceedings in the past ten years
has been conducted under these informal procedures. Although the
Commission's experience to date indicates that some of the original
objectives have been achieved, there have also been some aspects of the
informal procedures that have continued to prolong the proceeding
without truly enhancing the decisionmaking process. Given the
Commission's experience, and given the potential in the next few years
for new proceedings to consider applications for new facilities, to
renew reactor operating licenses, and to reflect restructuring in the
electric utility industry, the Commission concluded that it should
identify improvements to its hearing process that will result in a
better use of all participants' limited resources.
Accordingly, the Commission believes that a comprehensive
restructuring of the Commission's adjudicatory procedures is
appropriate. The procedures proposed in the recent Federal Register
notice should reduce the burden of litigation costs on applicants and
other participants because of the informal, less adversarial nature of
the hearing. Less formal procedures will also enhance the role of the
presiding officer as a technical fact finder by giving him or her the
primary responsibility for controlling the development of the hearing
record. This should lead to better adjudicatory decisions. Finally,
less formal procedures should result in more timely completion of
hearings and issuance of decisions.
______
Responses by Richard Meserve to Questions from
Senator Clinton
Question 1. Describe the regulatory activities that are planned or
underway, as well as the schedule and resources needed, to continue to
refine and improve the recently implemented risk-informed approach to
ensuring safe nuclear power plant operation.
Response. Refinement and improvement of the new Reactor Oversight
Process (ROP) are ongoing activities. The NRC has implemented a self-
assessment program to evaluate the overall success of the ROP in being
objective, risk-informed, understandable, and predictable, as well as
its success in meeting the agency's performance goals of maintaining
safety, protection of the environment and the common defense and
security; increasing public confidence; making NRC activities and
decisions more effective, efficient, and realistic; and reducing
unnecessary regulatory burden. On a periodic basis, the self-assessment
program collects information from various sources, including resource
utilization and performance databases, inspection program feedback,
periodic independent audits, stakeholder feedback, and public comment.
This information forms the basis to evaluate ROP effectiveness and
additional program improvements.
The most significant initiatives that are currently underway to
continue to improve and refine the ROP are discussed below. Most of
these activities are expected to be completed within the upcoming year,
and can be completed with the resources currently budgeted for the
continued development of the ROP. These initiatives are as follows:
<bullet> incorporate lessons learned from the first year of full
implementation, which ended in April 2001;
<bullet> investigate program areas and implement changes where
resource efficiencies can be gained;
<bullet> refine and streamline the significance determination
process;
<bullet> enhance inspector training;
<bullet> develop additional and more effective performance
indicators; and
<bullet> investigate areas where inspection procedures and
performance assessment can be streamlined.
The results of initial implementation indicate that current
regional and program development resource levels were adequate to carry
out the first year of the ROP effectively and to achieve its
objectives. Future resource reductions may be possible through
efficiencies gained as a result of the elimination of startup costs,
improvements to documentation methods, and refinements in the
significance determination process. In addition, savings may be
possible through reductions of plant-specific inspections (i.e., event
follow-up and inspections to follow up on significant performance
issues) contingent upon continued improvements in plant performance.
However, these will need to be weighed against emerging programs and
policies that may impact future resources.
In addition to implementing the ROP, the NRC has pursued
improvements to our regulations to make them more risk-informed. The
two major initiatives currently underway are commonly referred to as
``Option 2'' and ``Option 3''. Option 2 refers to our initiative to
risk-inform certain requirements in 10 CFR Part 50 that specify
quality, testing, inspection, and other ``special treatment''
requirements to be applied to structures, systems, and components
(SSCs) in nuclear power plants. The intent of the Option 2 rulemaking
is to provide an alternative set of requirements that would vary the
treatment applied to SSCs on the basis of safety significance using a
risk-informed categorization method. SSCs that are safety significant
would be subject to greater regulatory controls than those of lower
significance. The licensee for the South Texas plant has requested
exemptions from some of the existing ``special treatment''
requirements. The staff is evaluating the merits of this request and
expects to issue a final safety evaluation in the near future. The
South Texas plant application is viewed as a ``proof of concept'' for
the Option 2 approach through which we expect to gain valuable
experience.
Option 3 refers to our initiative to identify existing
``technical'' requirements in our reactor safety regulations that are
candidates for risk-informed regulation. One example of the potential
changes to the regulations concerns combustible gas control during
accidents to make the regulations more risk-informed and performance-
based. We are also considering other potential changes, particularly
with respect to our requirements concerning emergency core cooling
system operations.
Question 2. Explain how this new approach will maintain the same
level of safety, predictability, and consistency as the old approach.
Response. The revised Reactor Oversight Process (ROP) was developed
to maintain the level of safety of operating nuclear power reactors
while improving the predictability and consistency of the previous
process. It maintains safety by using inspections and performance
indicators to indicate safe operation within seven cornerstones of
safety: initiating events, mitigating systems, integrity of barriers to
the release of radioactivity, emergency preparedness, occupational
radiation safety, public radiation safety, and physical protection from
sabotage. Based on the significance of inspection and performance
indicator results, the NRC will take timely action to ensure that
licensees address performance issues before they result in unacceptable
performance.
The ROP has improved predictability in several ways. First, each
plant reports a set of performance indicators compared with pre-
established thresholds each calendar quarter. Second, inspection
findings are evaluated for their significance to safety using the
significance determination process. This objective, documented process
clearly communicates results, along with the underlying assumptions,
such that all stakeholders understand the significance of inspection
findings. And third, the process for assessing plant performance
combines the results of objective indicators and inspection findings
and uses a published ``action matrix'' to determine the actions the
agency will take to follow up performance problems and ensure they are
appropriately addressed. These aspects of the ROP make the NRC's
assessment process a more objective and predictable one.
The ROP has also improved consistency by: (1) more clearly defining
the base level of inspection, (2) relying on an objective process for
evaluating the significance of inspection findings and determining
follow up actions, and (3) relating enforcement actions to the
objective evaluation of findings and assessment of overall performance.
Also, the revised Reactor Oversight Process changed how the agency
documents its reactor inspections, primarily documenting the facts used
by inspectors to objectively evaluate the significance of the findings,
and eliminating subjective observations and conclusions.
The inspections under the ROP are more risk-informed; that is they
focus the NRC and licensees on areas of greater risk significance, and
place less focus on areas of lesser safety significance. More
information about each plant's safety performance is available to the
general public more frequently.
Question 3. Provide information on the performance indicators
selected for use in the new risk-informed approach, and how these
indicators will track all inspection, problem identification and
solution, human performance, safety conscious work environment, and
other issues.
Response. The revised Reactor Oversight Process (ROP) uses insights
obtained through performance indicators (PIs) along with the results of
risk-informed inspections to assess licensee performance and to
determine appropriate NRC actions to ensure performance issues are
addressed. Performance indicators provide objective and quantifiable
indication of licensee performance within each safety cornerstone.
(Information on ROP performance indicators is in Enclosure 1.) However,
performance indicators are not intended to be comprehensive. They are
complemented by risk-informed baseline inspections performed at all
operating reactor sites. Inspection results are evaluated using a
process that determines the significance of the findings. In the event
that a PI or inspection threshold is crossed, the NRC will take
appropriate action in accordance with the defined Action Matrix
(Enclosure 2). A fundamental premise of the ROP is that human
performance, safety-conscious work environment, and problem
identification and resolution are aspects of licensee performance that
cut across all cornerstones and will be assessed either explicitly in
each cornerstone through inspection or will be inferred through
cornerstone performance results from both PIs and inspection results.
Wherever possible, the NRC sought to identify performance
indicators as a means of measuring the performance of key attributes in
each of the cornerstone areas. Where such performance indicators could
not be identified, or where a performance indicator was identified but
was not sufficiently comprehensive, the NRC developed baseline
inspections. The NRC also identified the need for ``verification''
inspections to verify the accuracy and completeness of the reported
performance indicator data. In addition, inspections are conducted to
ensure that the causes of important events are well understood and that
licensee corrective actions are adequate to prevent recurrence.
Likewise, reactive inspections may be performed to follow up on
allegations. The results of these follow-up inspections will be
factored into the assessment process along with performance indicators
and risk-informed baseline inspections.
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Enclosure 2: IP2 Performance Details (Inputs to NRC Action Matrix)
assessment of performance indicators
The performance indicators for the cornerstones were in the
licensee response band over the entire assessment cycle with the
following exceptions:
<bullet> An Emergency Preparedness PI crossed the white threshold
for drill/exercise performance based on the fourth quarter 1999 PI
data. This was due to weaknesses in classifications, notifications, and
protective action recommendations. Licensee-reported data for the first
quarter 2000 show a return to the green range for this indicator. (PI1)
<bullet> A Mitigating Systems PI crossed the white threshold based
on excessive emergency diesel generator unavailability. This was due to
an improper setpoint for an Emergency Diesel Generator breaker as
revealed by investigation of the August 1999 event. This PI is
currently shown as green. (PI2)
<bullet> Due to the February 2000 steam generator tube failure, a
Barrier Integrity PI crossed the yellow threshold based on exceeding
the Technical Specification Leak Rate (ConEd Reported 109 gpm) for
Steam Generator Tube Integrity. Although prior to ROP implementation,
this PI data would have resulted in a degraded cornerstone in the first
quarter 2000. This PI is currently shown as green. (PI3)
<bullet> An Initiating Events PI crossed the white threshold based
on excessive reactor trip frequency. This was primarily due to the
August 1999 automatic and the February 2000 manual reactor trips.
Currently, the PI for reactor trip and unplanned power changes is shown
as gray because the plant has not operated at power for a sufficient
period of time for the PI to be considered valid. (PI4)
assessment of inspection findings
NRC inspections identified and/or confirmed risk significant
findings (above the green threshold) in three cornerstones: Initiating
Events, Mitigating Systems, and Emergency Preparedness. These were
based on applying the Significance Determination Process (SDP) to
findings that were the result of licensee performance problems or
issues.
<bullet> Based on inspection follow-up of the August 1999 event,
there were findings of substantial safety significance for the
Mitigating System Cornerstone based on the unavailability of certain
auxiliary feedwater components and a degradation in feed and bleed
capability. Some of the important licensee performance issues that led
to these findings were the improper configuration of a Station
Auxiliary Transformer Tap Changer and an improper setpoint for an
Emergency Diesel Generator breaker. Although this event predated the
reactor oversight process (ROP), it provided important insights about
ConEd performance. This event was evaluated from a risk perspective in
a feasibility study for the ROP which characterized this event as
having substantial safety significance (i.e., would be a yellow issue
under the ROP) due to the degradation of post accident feed and bleed
capability.
<bullet> Based on NRC observations of a September 1999 exercise, an
inspection finding for the Emergency Preparedness Cornerstone crossed
the white threshold based on a failure to identify an improper
classification during self-critique of a September exercise. (IF2)
<bullet> An inspection finding for the Initiating Event Cornerstone
crossed the red threshold based on a significant increase in the
likelihood of a steam generator tube rupture with a corresponding
increase in Core Damage Frequency (CDF) and large early release
frequency (LERF). This conclusion was based on a review of the February
2000 event which characterized the underlying problem as highly risk
significant. The licensee performance issue that led to this finding
resulted from poor performance during the steam generator (SG)
inspections conducted during the 1997 refueling outage, and indicated
weaknesses with ConEd's corrective action program. After significant
evaluation, the NRC concluded that this finding was red, which places
plant performance in the Multiple/Repetitive Degraded Cornerstone
column of the NRC Action Matrix. (IF3)
<bullet> Three Inspection findings for the Emergency Preparedness
Cornerstone crossed the white threshold because of problems associated
with ERO augmentation, accountability of onsite personnel, and joint
news center effectiveness. These inspection findings resulted in a
degraded cornerstone. (IF4, IF5, IF6).
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Question 4. Provide information about the quality of the plant
specific risk-assessments that provide the basis for the new risk-
informed regulatory approach, and whether these assessments accurately
reflect the existing behavior of the plants or need to be updated.
Response. Every nuclear power plant licensee has developed a
probabilistic risk assessment (PRA) to allow it to evaluate risks
associated with the operation of its facility. Most licensees
voluntarily update their PRAs to reflect changes in how their
facilities are designed and operated. Currently, there are no NRC-
endorsed quality standards for PRAs, but many licensees have subjected
their PRAs to a peer review (sometimes referred to as a certification)
process through an industry sponsored initiative. In addition, the NRC
is working with two national standards groups to develop a PRA quality
standard that is expected to be completed by the end of calendar year
2001.
The NRC reviews all proposed operating license amendments,
including any supporting risk analyses. In 1998, the NRC issued
regulatory guidance that is used by the NRC risk analysts to ensure
that PRA quality issues are adequately addressed prior to NRC approval.
The NRC's primary goal is to make good safety decisions. Such decisions
rely on risk assessment results to a varying extent. That is, some
decisions can be supported by a very general understanding of the risk
factors; others that are broader in scope require a detailed plant-
specific assessment. The NRC staff ensures that the licensee's risk
analysis is of sufficient quality to support each amendment requested.
Each case is supported by an NRC staff safety evaluation report. In
addition, the scope of an amendment may be restricted to accommodate
any perceived deficiencies in the risk analysis.
The NRC also uses probabilistic risk insights in the development
and implementation of the agency's revised reactor oversight process
(ROP). To assess the significance of inspection findings, senior risk
analysts have been assigned to NRC headquarters and each regional
office. These risk experts consider licensee comments, which can
include insights from a licensee's PRA, when assessing inspection
findings. If necessary, these analysts perform independent risk
assessments of licensee performance issues. In addition, all risk
assessments that the agency uses to evaluate licensee performance are
subjected to a multi-disciplined review panel to help ensure the
assessments are used in a consistent, coherent and appropriate manner.
Question 5. Describe how NRC intends to increase public confidence
in NRC as an effective regulator, and ensure appropriate public
participation in NRC's decision-making process.
Response. A number of activities have been initiated since the NRC
identified increasing public confidence as one of the four major goals
of our Strategic Plan. The NRC recognizes that effective communication
is essential to instilling confidence in the agency by the general
public, those we regulate, and other stakeholders. To improve
communication among ourselves and with our stakeholders, the agency has
launched several activities.
First, the staff have begun developing communication plans in
specific program areas to assist them in communicating key messages,
issues and initiatives. The plans identify points at which the public
should become involved in the activity, provide guidance to the staff
on the methods and tools to facilitate such involvement, and generally
organize and describe NRC's contacts with stakeholders.
Second, the agency has made training available to assist the staff
in planning public meetings, to emphasize the importance of improving
public communication, and to communicate in clear, plain language.
These courses are aimed at staff and managers who interact with the
public in the course of their duties.
In order to provide an indicator of our performance in the area of
increasing public confidence, the agency has instituted use of feedback
forms, which are distributed to attendees at public meetings. The
feedback forms gauge attendees' perceptions of how well the NRC staff
presented information and responded to questions, and provide an
overall assessment of the audiences' response to the effectiveness of
the meeting. The agency began using the forms last October in an 18-
month pilot program. At the end of the pilot program, we will assess
the form's usefulness for determining trends in public confidence, as
well as for identifying areas where public interactions could improve.
The agency has also begun re-designing our web site with the aim of
enhancing the public's understanding of our mission, goals, and
performance. The web redesign effort responds directly to stakeholders'
suggestions for the site and will improve navigability and timeliness
and accuracy of information. The new site will ultimately provide
information that directly assists the public in their efforts to become
involved in the regulatory process.
In addition, the staff has held a variety of public meetings with
stakeholders over the last several years, to obtain their input and
comments regarding the agency's direction in specific program areas. In
April, the staff held a public meeting with interested stakeholders
specifically to hear their thoughts on how the NRC might improve its
public participation policies and practices. The staff is in the
process of reviewing the suggestions and comments received at the
meeting, and will be incorporating many of them into a report with
recommendations to the Commission this summer. The report will focus on
improvements to the agency's meeting processes, availability of
documents to the public, and general public participation and
involvement in our regulatory activities.
The agency also believes that effective communication among and
between NRC staff and management is highly instrumental in building and
maintaining an environment in which safety, excellence, teamwork,
creativity and innovations are essential to achieving our public
confidence goals. We are in the process of developing initiatives which
will ultimately improve the effectiveness and efficiency of NRC's
internal communications.
Question 6. Please provide an update on NRC's inspections and other
activities at Indian Point 2. Does the NRC intend to increase
inspections at Indian Point 2 in light of recent performance problems?
Response. Over the past few years, NRC inspection and oversight
activities at Indian Point Unit 2 (IP2) have been very substantial. In
May 2000, senior NRC managers concluded that the performance of the IP2
plant warranted an agency-focus classification. Later in the year,
after completing an assessment of multiple inspection findings and
performance indicators, including performance problems associated with
the August 1999 reactor trip and February 2000 steam generator tube
failure, IP2 was designated a plant with Multiple Degraded Cornerstones
under NRC's revised Reactor Oversight Process. As a result, the NRC
performed significant supplemental inspection of this plant. (As a
result, inspection hours over the last year at IP2 have been
approximately double that of any other single-unit site.)
The NRC recently completed its end-of-cycle plant performance
assessment for the period of April 2, 2000 through March 31, 2001
(enclosed). Although the NRC has determined that IP2 operated in a
manner that preserved public health and safety, the plant remains in
the Multiple Degraded Cornerstone column of the NRC's Action Matrix.
This assessment was based on results from several extensive inspections
completed by the NRC, including a supplemental team review by 14
inspectors in January and February of this year. This team determined
that while some performance improvements were noted, progress has been
slow overall and limited in some areas. In order to verify that
appropriate corrective actions have been taken to address previously
identified performance issues, the NRC plans to again conduct several
activities beyond the NRC baseline inspection program at the facility
during this year. These activities include supplemental inspections to
review progress in addressing the underlying issues that resulted in
the degraded cornerstones. These focused inspections will also provide
insight on the licensee's performance improvement efforts.
Additionally, site visits, management meetings, and quarterly
assessments will be conducted as necessary.
______
May 31, 2001.
Mr. John Groth, Senior Vice President,
Nuclear Operations, Consolidated Edison Company of New York, Inc.,
Buchanan, NY.
Subject: Annual Assessment Letter--Indian Point Unit 2
Dear Mr. Groth: On May 8, 2001, the NRC staff completed its end-of-
cycle plant performance assessment of Indian Point Unit 2 (IP2). The
end-of-cycle review for IP2 involved the participation of all technical
divisions in evaluating performance indicators (PIs) for the most
recent quarter and the inspection results for the period April 2, 2000
to March 31, 2001. The purpose of this letter is to inform you of our
assessment of your safety performance during this period and our plans
for future inspections at your facility.
Overall, IP2 operated in a manner that preserved public health and
safety. While IP2 met all cornerstone objectives, it remained in the
Multiple/Repetitive Degraded Cornerstone column of the NRC's Action
Matrix. The degraded cornerstones were based on several inspection
findings and performance indicators in the initiating events,
mitigating systems, and emergency preparedness cornerstones. These
degraded cornerstones are associated principally with performance
problems identified during an August 1999 reactor trip with electrical
distribution system complications, and a February 2000 steam generator
tube failure (SGTF). Additionally, there were two white PIs that
occurred during the assessment period in the initiating events and
mitigating systems cornerstones. Enclosures 1 and 2 provide additional
details regarding performance indicators and significant inspection
findings for degraded cornerstones.
Several significant activities occurred over the assessment period.
The plant began the assessment period in a cold shutdown condition due
to the February 15, 2000, SGTF event. In August 2000, you initiated the
SG replacement project which was completed in early November. The NRC
noted generally good performance during SG replacement. Subsequently,
the plant was readied for startup, heatup began in December, and the
reactor was brought critical on December 30. Although there were some
emergent issues during power escalation, the plant reached full power
by the end of January. In parallel with your activities, the NRC
completed a number of inspections and assessments. For example, our
December 22, 2000, letter, highlighted, among other activities, system
readiness walkdowns; augmented restart coverage by NRC inspectors; and
inspection of emergent issues affecting design inputs and analyses,
including an assessment of your corrective actions in addressing
recurring issues.
During the time frame encompassing plant startup, you had a number
of issues in design control, equipment reliability, problem
identification and resolution, and human performance. In the area of
design control, for example, a December 2000 inspection identified
further examples of the lack of formal design interface controls, and
weaknesses in your organization's ability to correct this condition.
Equipment reliability issues were illustrated by secondary plant
equipment problems which caused several power reductions in the plant
restart phase. With respect to human performance, a January 2, 2001,
turbine trip revealed problems with procedure quality and usage, crew
communications, and reactivity management. Throughout this time frame,
we monitored your corrective actions to address these issues.
In January and February 2001, an extensive supplemental team
inspection was conducted by 14 inspectors using NRC Inspection
Procedure 95003. The team concluded that the IP2 facility is being
operated safely. The team also noted problems similar to those that
have been previously identified at the IP2 facility, including those in
the areas of design control, human and equipment performance, problem
identification and resolution, and emergency preparedness. While some
performance improvements were noted, progress was slow overall and
limited in some areas. One such area is that of design control, where
recurrent problems have been noted, for example, in the translation of
important design assumptions into plant operating procedures, drawings,
calculations, and testing programs. Also, the team noted that although
some improvement in your problem identification and resolution program
has occurred, aspects of your program warrant continued attention
(e.g., prioritizing issues for resolution, trending causal factors,
timeliness and the effectiveness of corrective actions).
While the team noted that your business plan relies heavily on
department level implementation strategies that varied in quality and
depth, the team found that appropriate alignment exists between the
business plan and previously identified performance issues at the
facility. We consider your May 7, 2001, letter captured well the nature
of the issues that you are facing. We agree, as you stated in this
response, that the issues facing IP2 are not amenable to ``fast
fixes,'' and that many of your improvement efforts will necessitate
multi-year efforts. The NRC plans to carefully monitor the
effectiveness of your performance improvement efforts, including the
effect of any significant changes to your business plan or the
department level activities either prior to or subsequent to any
license transfer.
In order to verify that appropriate corrective actions have been
taken to address the previously identified performance issues, the NRC
plans to conduct several activities beyond the NRC baseline inspection
program at the facility. These activities include supplemental
inspections to review progress in addressing the underlying issues that
resulted in the degraded cornerstones. These focused inspections will
also provide insights into your performance improvement efforts.
Enclosure 3 details inspections that are planned through May 31, 2002.
The inspection plan is provided to minimize the resource impact on your
staff and to allow for scheduling conflicts and personnel availability
issues to be resolved prior to onsite arrival. Routine resident
inspections are not listed due to their ongoing and continuous nature.
Additionally, site visits, management meetings, and quarterly
assessments, will be conducted as necessary. In this regard, we
conducted a meeting on April 30, 2001, focused principally on design
and engineering issues.
Consistent with the Reactor Oversight Process, we are finalizing
plans to meet with you to discuss NRC's assessment of your performance,
and your continuing actions to effect performance improvement at IP2.
This meeting, which will be open for public observation, is scheduled
for 7 p.m., June 13, 2001, at the Energy Education Center.
Additionally, consistent with guidance in the NRC Action Matrix, the
NRC considered the need for additional regulatory actions beyond those
described herein, and has concluded that none are required at this
time. The staff will continue to consider the appropriateness of
additional regulatory actions as new performance information becomes
available. Finally, in accordance with IMC 0305, ``Operating Reactor
Assessment Program,'' IP2 will be discussed at the upcoming Agency
Action Review meeting. We will notify you via separate correspondence
if any agency actions change, as an outcome of this meeting.
For your information, the NRC is in the process of aligning the
inspection and assessment cycle with the calender year. In order to
transition to a calender year cycle (January 1-December 31), the next
inspection and assessment cycle will consist of only three quarters
(i.e., the second, third and fourth calender quarters of CY 2001). As a
result, for all plants a quarterly review will be conducted for the
third calender quarter (July 1- September 30) in lieu of a mid-cycle
review.
In accordance with 10 CFR 2.790 of the NRC's ``Rules of Practice,''
a copy of this letter and its enclosure will be available
electronically for public inspection in the NRC Public Document Room or
from the Publicly Available Records (PARS) component of NRC's document
system (ADAMS). ADAMS is accessible from the NRC Web site at http://
www.nrc.gov/NRC/ADAMS/index.html (the Public Electronic Reading Room).
To get information about the assessment terms used in this document
refer to NRC's program for overseeing the safe operation of commercial
nuclear power reactors. It is described in the NRC Reactor Oversight
Process web site at http://www.nrc.gov/NRR/OVERSIGHT/index.html.
If circumstances arise which cause us to change this inspection
plan, we will contact you to discuss the change as soon as possible.
Please contact Mr. Peter Eselgroth at 610-337-5234 with any questions
you may have regarding this letter or the inspection plan.
Sincerely,
Hubert J. Miller,
Regional Administrator.
______
Responses by Richard Meserve to Questions from Senator Corzine
Question 1a. I am concerned about the revised regulations governing
nuclear medicine in 10 CFR Part 35 that are now under review at OMB.
You cited these revisions in your testimony as a success story in the
NRC's efforts to use risk to guide regulations. Yet a 1996 National
Academy of Sciences/Institute of Medicine study concluded that
revisions to the reporting and enforcement systems along the lines you
have proposed would result in negligible decreases in risks to health
care providers and patients. On the other hand, I understand that the
estimated costs of your revised regulations run as high as $500
million. On the basis of these facts, I am concerned that your changes
to these regulations will unnecessarily expend scarce health resources.
Please provide a summary of both the methodology and the results of
the risk assessments that informed the revisions to 10 CFR Part 35 that
are now under review at OMB.
Response. The Commission's revisions to Part 35 were developed
after the National Academy of Sciences, Institute of Medicine (NAS-IOM)
Report was published in 1996 and used risk information developed by
NAS-IOM in formulating the revised requirements. That is, Part 35 now
pursues a risk-informed approach which decreased the burden for those
types of medical activities which pose a low risk to health care
providers, members of the public, and patients. Conversely,
requirements have been strengthened for those activities that pose a
more significant risk in order to assure the safe handling of NRC-
regulated nuclear materials in a medical setting. The figure of $500
million for the cost of the revised regulation is not an NRC estimate.
The final Regulatory Analysis prepared by the NRC for the 10 CFR Part
35 rulemaking examines the difference in the cost of compliance with
the revised regulation with the cost of compliance with the existing
regulation. That estimate shows a net reduction of $8,836,000 per year
for licensees in NRC and Agreement States as a result of the revised
regulations.
A formal risk assessment was not conducted. In determining that a
formal risk assessment would not be conducted, the Commission was aware
that the data necessary to perform a relative risk assessment may not
be available. The National Academy of Sciences, Institute of Medicine
(NAS-IOM) Report on Radiation in Nuclear Medicine: A Need for
Regulatory Reform (National Academy Press, 1996) included risk
assessment information, as well as a discussion of the comparative risk
of ionizing radiation in medicine to risks in other medical modalities
(Chapter 4). The NAS-IOM report concluded that ``no comprehensive raw
data are available to make exact comparisons'' between risks of medical
modalities (pg. 124). The report recognized that quantifying levels of
risk in radiation medicine is problematic (pg. 128). The Commission's
Advisory Committee on the Medical Uses of Isotopes also recognized that
quantifying levels of risk in radiation medicine is problematic in a
May 8, 1997 Commission briefing.
The Commission opted to restructure 10 CFR Part 35 into a more
risk-informed, more performance-based regulation by focusing on those
medical procedures that pose the highest risk from a radiation safety
standpoint. At the Commission's direction, the NRC staff carefully
considered the risk information in several extensive assessments,
including the external review conducted by NAS-IOM, a 1993 NRC internal
senior management review and report, and the Commission's Strategic
Assessment and Rebaselining initiative. This information, along with
the information in the NRC's event databases and the input received
during the enhanced rulemaking participatory process, was used to
determine the requirements that are necessary to ensure radiation
safety during the medical use of byproduct material. Consideration of
all of this information resulted in reduction of regulatory burden by
eliminating or decreasing the prescriptiveness of various requirements
that apply to the lower-risk area of diagnostic medical procedures.
Question 1b. Please explain why the conclusions of the 1996 NAS/IOM
study were apparently disregarded in your revision of 10 CFR Part 35.
Response. The National Academy of Sciences, Institute of Medicine
(NAS-IOM) study was conducted because NRC sought an evaluation of
whether the rules, policies, and procedures of the current regulatory
framework for medical uses of byproduct material fulfilled the NRC's
statutory responsibilities for public health and safety. The Commission
was not persuaded by the NAS-IOM report's overall recommendation to
Congress, that NRC should not be the Federal agency involved in the
regulation of ionizing radiation in medicine, based, in part, on
comments received from some State and Federal agencies. For example,
the Food and Drug Administration, to which additional responsibility
would have fallen if the NRC adopted the recommendation, indicated that
it did not support the recommendation. The Commission continues to
believe that the conclusions in the report were not substantiated and
that this particular recommendation should not be pursued.
The report was not rejected on the basis of its analysis of risks
of ionizing radiation in medicine. In fact, the risk assessment
information in the report, including the information on comparative
risks of ionizing radiation in medicine, was considered during the
rulemaking process. As stated above, the NAS report concluded that ``no
comprehensive raw data are available to make exact comparisons''
between risks of medical modalities (pg. 124), and it recognized that
quantifying levels of risk in radiation medicine is problematic.
Question 1c. Please provide any cost-benefit analyses that you
developed in support of the revisions to 10 CFR Part 35.
Response. The Final Regulatory Analysis for the 10 CFR Part 35
rulemaking analyzes the regulatory burden for the revised regulation
and compares it to the regulatory burden for the existing 10 CFR Part
35. This analysis concluded that the revisions to 10 CFR Part 35 will
result in a total annual cost savings of $8,836,000 to medical
licensees in NRC and Agreement States (pg. 6-5). In addition to the
cost savings, benefits of the revisions to Part 35 include more focused
and more performance-based requirements for the implementation of the
Quality Management program, specific necessary training for different
types of medical treatment such as high dose rate brachytherapy, and
reporting of medical events to NRC. Copies of the Final Regulatory
Analysis are being provided with the response to this question.
______
Final Regulatory Analysis; 10 CFR Parts 20, 32, and 35; Comprehensive
Revision of 10 CFR Part 35; ``Medical Use of Byproduct Material'' and
Petition for Rulemaking; ``Revision of Dose Limit for Members of the
Public Exposed to Hospitalized Patients''; (PRM-20-24); Amending 10 CFR
Part 20 ``Standards for Protection Against Radiation''; and Conforming
Amendment to 10 CFR Part 32; ``Specific Domestic Licenses to
Manufacture or Transfer Certain Items Containing Byproduct Material''
1. background
10 CFR Part 35
NRC's Medical Use Program includes uses of byproduct material in
medical diagnosis, therapy, and research. There are approximately 1,655
NRC licenses authorizing the medical use of byproduct material under 10
CFR Part 35. There are approximately 4,138 State licenses in Agreement
States authorizing the medical use of byproduct material. It's
estimated more than twelve million patients annually have nuclear
medicine procedures involving byproduct materials. \1\ Use of
teletherapy, brachytherapy, and gamma stereotactic radiosurgery for
treatment involves more than half-a-million patients annually. \2\
---------------------------------------------------------------------------
\1\ A survey performed for the Society of Nuclear Medicine in 1993
estimated that about 10.7 million procedures were performed annually.
Clouse, J.C., Rogers, M., Carretta, R.F., et al., Future Nuclear
Medicine Physician Requirements, J. Nucl. Med., May 1996 (37:5), 14N-
18N (Figures 2 and 3). A more recent estimate places the number of
procedures in 1997 at about 12.9 million. (Communication with Dr. M.
Polycove, September 1999).
\2\ Estimate based on estimated number of new cancer cases treated
with radiation provided by the American Cancer Society to the National
Academy of Sciences, Institute of Medicine, National Academy of
Sciences, Radiation in Medicine, Washington, DC, 1996, 65-67.
Tabulations by the American College of Radiology of Medicine data (Part
B Medicare Annual Data) for 1997 show approximately 33,000
brachytherapy procedures and approximately 75,000 cobalt teletherapy
applications for Medicare patients. As a general rule, the total for
all Americans is approximately 3 times the Medicare total or about
100,000 brachytherapy and approximately 225,000 teletherapy procedures.
However, this 3 to 1 approximation is less accurate for quite specific
procedures, as here, than it is for broad ranges of health care
services.
---------------------------------------------------------------------------
During the last 6 years, the Nuclear Regulatory Commission (NRC)
has examined the issues surrounding its regulations governing the
medical use of byproduct material (10 CFR Part 35), and now is enacting
a comprehensive revision of those regulations.
The NRC's reexamination of 10 CFR Part 35 began in 1993 with an
internal senior management review report prepared by NRC. NRC then
sponsored an external study, conducted between January 1994 and 1996,
by the National Academy of Sciences, Institute of Medicine. 10 CFR Part
35 also was addressed in NRC's Strategic Assessment and Rebaselining
Project (SA), culminating in the SA Direction-Setting Issue Paper
Number 7 (DSI 7) released September 16, 1996. On March 20, 1997, the
Commission issued a Staff Requirements Memorandum (SRM) (``COMSECY-96-
057, Materials/Medical Oversight (DSI 7)'') directing the staff to
revise 10 CFR Part 35 to restructure it into a more risk-informed, more
performance-based regulation.
On August 13, 1998, NRC published proposed revisions to 10 CFR Part
35 in the Federal Register (63 FR 43516). The public comment period on
this proposed rule expired on November 12, 1998. The NRC subsequently
reopened the public comment period until December 16, 1998 (63 FR
64829). The NRC staff reviewed the public comments and evaluated
possible changes to the proposed rule. On March 25, 1999, the staff and
members of the Advisory Committee on Medical Uses of Isotopes briefed
the Commission on the public comments and the proposed responses to the
comments.
In a Staff Requirements Memorandum (SRM) dated April 23, 1999, the
Commission requested that staff provide it with a paper providing draft
final rule text and those portions of the statements of consideration
that discuss resolution of public comments and provide enough
information to allow comparison of the changes from the current rule to
the proposed rule and the draft final rule. In a SRM dated February 16,
2000, the Commission requested the NRC staff incorporate specific
changes to the draft final rule language and responses to public
comments.
10 CFR Part 20
At the same time that it is revising Part 35, the NRC also is
amending its regulations in 10 CFR Part 20, Standards for Protection
Against Radiation, in response to a Petition for Rulemaking (PRM-20-24)
dated April 7, 1996, from the University of Cincinnati. PRM-20-24
requests NRC to authorize ``specified visitors'' of hospitalized
radiation therapy patients, as individual members of the public, to
receive up to 5 mSv (0.5 rem) per year, rather than the current limit
of 1 mSv (0.1 rem) in 10 CFR 20.1301.
The 1991 revision of 10 CFR Part 20 (56 FR 23398; May 21, 1991)
established a public dose limit of 1 mSv (0.1 rem) per year (10 CFR
20.1301(a)). 10 CFR 20.1301(c) permits licensees to request NRC
authorization to operate up to an annual dose limit for an individual
member of the public of 5 mSv (0.5 rem) per year. However, fewer than
10 medical licensees have applied for such an NRC authorization for
visitors since the 1991 revision. Under 10 CFR 35.75(a), a licensee who
is an authorized user of byproduct materials for medical use may
authorize the release from its control of any patient who has been
administered radiopharmaceuticals or permanent implants containing
radioactive material if the total effective dose equivalent to any
other individual from the released patient is not likely to exceed 5
mSv (0.5 rem).
The petitioner in PRM-20-24 requested that the NRC amend 10 CFR
20.1301 to authorize ``specified visitors'' of hospitalized radiation
therapy patients, as individual members of the public, to receive up to
5 mSv (0.5 rem) per year. The petitioner argued that the higher dose
limit is appropriate for visitors determined by the physician to be
necessary for the emotional or physical support of the patient (e.g.,
parents of very young radiation therapy patients, close family members
of elderly patients, or other persons who could provide emotional
support to the patient).
The proposed revision to Part 20 was published in the Federal
Register on August 13, 1998 (63 FR 43516). The public comment period on
the proposed rule ended December 16, 1998.
10 CFR Part 32
References to certain sections of Part 35 contained in Part 32 are
being revised to conform Part 32 to the revisions in Part 35.
1.1 Statement of the Problem
10 CFR Part 35
NRC has identified the following six problems that require
revisions to 10 CFR Part 35. \3\
---------------------------------------------------------------------------
\3\ The Commission, in its Staff Requirements Memorandum (SRM)-
COMSECY-96-057 dated March 20, 1997, also directed the NRC staff to
consider a seventh issue, the best way to capture not only relevant
safety-related events, but also precursor events. After detailed
consideration, including comments from a wide variety of stakeholders
and the public, proposals for addressing precursor events were not
adopted for the final rule.
---------------------------------------------------------------------------
First, revisions are needed to address the unnecessarily overly
prescriptive nature of specific sections of 10 CFR Part 35 that result
in costs to licensees without commensurate health and safety benefits.
Although licensees currently have the option of adopting alternative
measures, this requires a license amendment. License amendments are
costly both to the licensee and to NRC.
Second, revisions are needed to place the basis for regulation of
certain well-established technologies into 10 CFR Part 35.
Specifically, the regulations in 10 CFR Part 35 currently do not
address high dose-rate remote brachytherapy, low dose-rate remote
brachytherapy, pulsed dose-rate remote brachytherapy, and gamma
stereotactic radiosurgery. The regulatory basis for these technologies
currently is established by license conditions rather than regulations.
Third, revisions are needed to provide for the incorporation of new
technologies in a timely manner. Currently, new technologies must be
licensed through case-by-case reviews in which the applicant or
licensee must submit a request for an exemption for technologies not
specifically addressed in 10 CFR Part 35.
Fourth, the regulations in Sec. 35.2, regarding thresholds for
misadministrations, are not entirely dose based. These regulations do
not address new technologies or patient intervention, nor do they
provide a threshold for wrong treatment site. Further, the Commission
directed the staff to consider changing the nomenclature from
``misadministration'' to ``medical event.''
Fifth, the requirements in Subpart J, concerning training and
experience, include requirements for clinical experience in all
modalities. Because diagnostic procedures present a lower overall risk,
as compared to therapeutic procedures, most of the supervised clinical
experience currently required may not be necessary for most diagnostic
uses.
Sixth, the regulations now permit medical use licensees to hold
byproduct material with a half-life less than 65 days for decay-in-
storage for a minimum of ten half-lives before disposal in ordinary
trash. Licensees now must obtain a license amendment exempting them
from the requirements of Sec. 35.92 for materials with longer half-
lives or to hold material for less than ten half-lives.
10 CFR Part 20
Revisions to 10 CFR Part 20 are required because the 100 mrem
public dose limit in 10 CFR 20.1301(c) is overly restrictive with
respect to visitors to patients undergoing therapy involving byproduct
material. This is a problem because there are occasions when additional
access to the radiation therapy patient by family or friends, as
determined by the authorized user physician, is necessary to provide
both physical and emotional support while the patient is under licensee
control.
10 CFR Part 32
Revisions to 10 CFR Part 32 are required to conform references to
Part 35 in Part 32 to the revised Part 35.
1.2 Earlier NRC Actions
10 CFR Part 35
The NRC published an announcement of its program for revision of 10
CFR Part 35 and a request for public input on the rule development in a
document published in the Federal Register on August 6, 1997 (62 FR
42219). The NRC staff adopted a modality approach to the 10 CFR Part 35
rule. The final rule addresses the following modalities: (1) unsealed
byproduct material--written directive not required; (2) unsealed
byproduct material--written directive required; (3) manual
brachytherapy; (4) sealed sources for diagnosis; (5) photon emitting
remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units; and (6) other medical uses of byproduct material or
radiation from byproduct material.
Development of the text of the final rule as well as draft guidance
documents was done by a governmental Working Group and a Steering
Group. Representatives of the Organization of Agreement States and the
Conference of Radiation Control Program Directors, Inc. were members of
both the Working Group and the Steering Group.
The NRC convened or participated in a number of public workshops
and meetings to discuss the fundamental approaches and issues to be
addressed in the rulemaking. These workshops and meetings were intended
to ensure that the interests affected by the medical use rulemaking
were given an early opportunity to comment on the rulemaking issues and
to discuss the rulemaking issues with one another and the NRC. NRC
participated in a workshop held during the Organization of Agreement
States' 1997 All Agreement States meeting on October 18, 1997 in Los
Angeles, California. (See 62 FR 52513; October 8, 1997). The All
Agreement States meeting was attended not only by representatives of
the 30 Agreement States but also by the public. NRC convened two
facilitated public workshops, in Philadelphia, Pennsylvania on October
28, 29, and 30 and in Chicago, Illinois on November 12, 13, and 14,
1997. (See 62 FR 53249; October 14, 1997). These workshops were
attended by nuclear medicine physicians; radiation oncologists; other
specialists (e.g., cardiologists and radiologists); medical physicists;
medical technologists; nurses; medical education and certification
organizations; radiopharmaceutical interests; hospital administrators;
patients' rights advocates; Agreement States; Federal agencies; and
members of the public. In addition, the Advisory Committee on the
Medical Uses of Isotopes (ACMUI), an NRC advisory committee, discussed
the issues regarding the revision of 10 CFR Part 35 in its meetings on
September 25 and 26, 1997 and March 1 and 2, 1998. Finally, NRC staff
attended meetings with numerous groups representing physicians,
pharmacists, medical physicists, technologists, and other stakeholders.
The two facilitated workshops sponsored by the NRC, as well as
NRC's participation in other meetings, were intended to foster a
clearer understanding of the positions and concerns of the affected
interests, and were not intended to develop a consensus agreement of
the participants on the rulemaking issues. However, the proposed rule
was the evolutionary result of these numerous meetings, as well as the
reasoned consideration of the Working Group and Steering Group.
Following the August 13, 1998, publication of the proposed rule,
NRC convened three facilitated workshops during the public comment
period on the proposed rule to provide an opportunity for the affected
interests and other members of the public to discuss the proposed rule.
(These meetings were held in San Francisco, California on August 19 and
20, 1998; in Kansas City, Missouri on September 16 and 17, 1998; and in
Rockville, Maryland on October 21 and 22, 1998.) In addition, NRC staff
attended a meeting of the Association of Agreement States held on
October 31, 1998. NRC staff also met with members of medical
specialties boards on February 17-18, 1999. A Diagnostic Subcommittee
of the ACMUI met in Rockville, Maryland on February 23-24, 1999, and a
Therapeutic Subcommittee of the ACMUI met in Rockville, Maryland on
February 25-26, 1999, to discuss issues raised by the Part 35
rulemaking. A meeting of the full ACMUI to discuss the Part 35
rulemaking was held on March 24-25, 1999.
10 CFR Part 20
The analysis of PRM-20-24 began on June 21, 1996 (61 FR 31874),
when the NRC published a notice of receipt and a request for comment on
the petition. All commenters agreed with the petitioner that it was
unreasonable to require licensees to limit doses to specified visitors
to the public dose limit of 1 mSv (0.1 rem). A draft rulemaking plan
was prepared and provided to the Agreement States on May 1, 1997, for
review and comment, and a final rulemaking plan was submitted to the
Commission for approval on August 1, 1997. The NRC consolidated action
on PRM-20-24 with the 10 CFR Part 35 rulemaking in January, 1998.
2. objectives of the rulemaking
10 CFR Part 35
In its ``Staff Requirements Memorandum (SRM)-COMSECY-96-057,
Materials/Medical Oversight (SDI 7),'' dated March 20, 1997, the
Commission directed the staff to revise 10 CFR Part 35; associated
guidance documents; and, if necessary, the Commission's 1979 Medical
Policy Statement. The Commission's SRM specifically directed the
restructuring of 10 CFR Part 35 into a more risk-informed, more
performance-based regulation. During development of the final rule and
associated guidance as well as during review of the Medical Policy
Statement, the NRC staff was directed to consider the following issues:
(1) Focusing 10 CFR Part 35 on those procedures that pose the
highest risk;
(2) Regulatory oversight alternatives for diagnostic procedures
that are consistent with the lower overall risk of these procedures;
(3) The best way to capture not only relevant safety-significant
events, but also precursor events;
(4) The need to change from the term ``misadministration'' to
``medical event'' or other comparable terminology;
(5) Redesigning 10 CFR Part 35 so that regulatory requirements for
new treatment modalities can be incorporated in a timely manner;
(6) Revising the requirement for a quality management program (10
CFR 35.32) to focus on those requirements that are essential for
patient safety (e.g., confirming patient identity requiring written
directives, and verifying dose; and
(7) The viability of using or referencing available industry
guidance and standards, within 10 CFR Part 35 and related guidance, to
the extent that they meet NRC's needs.
In carrying out these objectives, the NRC also sought the
following:
<bullet> Restructuring 10 CFR Part 35 to incorporate a modality-
based approach;
<bullet> Reducing or eliminating duplication or overlaps between 10
CFR Part 35 and other Parts of 10 CFR, particularly 10 CFR Part 20; and
<bullet> Reducing recordkeeping and/or reporting requirements
whenever possible.
10 CFR Part 20
The objective of the rulemaking to address PRM-20-24 is to permit
authorized user physicians the discretion to permit specified visitors
to receive doses in excess of the 1 mSv (0.1 rem) public dose limit in
order to provide physical and emotional support to hospitalized
individuals administered radioactive materials or radiation from
byproduct materials.
3. alternatives
The following alternatives were considered in this analysis:
Alternative One:
10 CFR Part 35: Continue 10 CFR Part 35 without revision.
10 CFR Part 20: Deny PRM-20-24 and retain the 1 mSv (0.1 rem)
public dose limit for visitors of radiation therapy patients on the
basis that there are sufficient provisions within 10 CFR 20.1301(c) to
allow case-by-case use of the 5 mSv (0.5 rem) annual dose limit for
visitors of radiation patients.
10 CFR Part 32: Continue 10 CFR Part 32 without revision.
Alternative Two:
10 CFR Part 35: Promulgate comprehensive revisions to 10 CFR Part
35 that relax certain prescriptive requirements currently contained in
10 CFR Part 35 with respect to Radiation Safety Committees, quality
management, training and experience, reporting and recordkeeping, and
other requirements currently covered by both 10 CFR Part 35 and 10 CFR
Part 20. Substitute new requirements with respect to training and
experience. Incorporate new requirements for therapeutic uses of
radionuclides, including requirements for remote afterloaders, and
gamma stereotactic radiosurgery.
10 CFR Part 20: Promulgate a new dose limit of 5 mSv (0.5 rem), as
requested under PRM-20-24, including a requirement to provide basic
radiation safety instruction for specified visitors of radiation
therapy patients, but no requirement for visitor badging or
recordkeeping.
10 CFR Part 32: Promulgate conforming changes to reflect changes to
10 CFR Part 35.
The staff selected alternative two as the preferred option.
4. underlying data and assumptions
The following data and assumptions were used to evaluate the values
and impacts of the alternatives for revisions to 10 CFR Part 35 and
response to PRM-20-24.
4.1 Number and Type of Licensees
Table 1 provides data from NRC's License Tracking System on the
number of NRC 10 CFR Part 35 licensees, by category, as of July 1999.
The number of Agreement States licensees is estimated at 2.5 times the
number of NRC licensees, based on discussions with cognizant staff of
the NRC Office of State and Tribal Programs. Estimates throughout are
based on the assumption that Agreement States will adopt all of the
regulatory changes.
Table 1.--Number and Type of Licenses
------------------------------------------------------------------------
Program Agreement
Code \1\ NRC \2\ States \3\
------------------------------------------------------------------------
Numbers and Types of Medical
Licensees:
Medical Institution-Broad...... 2110 74 185
Medical Institution-QMP Req.... 2120 767 1,919
Medical Institution-QMP Not Req 2121 135 338
Medical Private Practice-QMP 2200 133 333
Req...........................
Medical Private Practice-QMP 2201 325 813
Not Req.......................
Eye Applicators Strontium-90... 2210 20 50
Mobile Nuclear Medicine Service 2220 44 110
High Dose-Rate Remote 2230 97 243
Afterloader...................
Medium and Low Dose-Rate Remote \4\ 24 \4\ 60
Afterloader...................
Pulse Dose-Rate Remote 0 \5\ 35
Afterloader...................
Mobile HDR Remote Afterloader.. 2231 4 \6\ 3
Mobile Therapy................. 2240 0 0
Teletherapy.................... 2300 17 43
Gamma Stereotactic Radiosurgery 2310 15 38
--------------------------------------
Total........................ 1,655 4,138
------------------------------------------------------------------------
\1\ NRC Material License Program Codes.
\2\ Data from NRC License Tracking System (LTS), February 2001.
\3\ Estimated, based on 1 to 2.5 ratio of NRC licensees to Agreement
States licensees.
\4\ Not based on NRC License Tracking System; estimated based on
information supplied by ACMUI, March 2, 1998. These data constitute
upper bound estimates, due to shifts from use of LDR to HDR when
feasible.
\5\ Estimated, based on information supplied by ACMUI, March 2, 1998.
\6\ Estimated, based on information supplied by NRC Office of State and
Tribal Programs.
4.2 General Administrative Activities
Table 2 provides estimates of the numbers of activities or persons
subject to the general administrative requirements of 10 CFR Part 35,
such as Radiation Safety Officers, meetings of Radiation Safety
Committees, and license amendments under 10 CFR Part 35. It also
provides estimates of the number of individuals per year becoming
authorized users, authorized nuclear pharmacists, Radiation Safety
Officers, or medical physicists for the first time.
Table 2.--General Administrative Activities
------------------------------------------------------------------------
Agreement
NRC States
------------------------------------------------------------------------
Number of Radiation Safety Officers \1\....... 1,655 4,137
Number of Medical Institutions with Quality 1,166 2,014
Management Plans \2\.........................
Number of License Amendments Completed 1,655 3,310
Annually \3\.................................
------------------------------------------------------------------------
------------------------------------------------------------------------
NRC and
Agreement
States
------------------------------------------------------------------------
Number of individuals per year \4\ seeking certification
for:
Uptake, Dilution, and Excretion Studies............... 110
Imaging and Localization Studies...................... 110
Therapeutic Unsealed Sources.......................... 100
Oral administration of sodium iodide I-131............ 100
Ophthalmic use of Strontium-90........................ 15
Brachytherapy......................................... 150
Sealed Sources for Diagnosis.......................... 80
Therapeutic Medical Devices........................... 150
Nuclear Pharmacist.................................... 20
Medical Physicist..................................... 100
------------------------------------------------------------------------
\1\ Estimated for current rule, based on regulatory requirement that all
licensees must appoint an RSO.
\2\ Total of program codes 2110, 2120, 2200, 2210, 2230, 2231, 2240,
2300, and 2310 for NRC licensees. Agreement States estimate adjusted
to reflect the proportion of Agreement States (9 of 30, according to
data provided by the NRC Office of State and Tribal Programs in 1998)
that have not adopted a quality management rule.
\3\ Estimated as one amendment per year per licensee for current rule
for NRC licensees and one amendment per year for 80 percent of
Agreement State licensees. This represents an upper bound estimate.
According to NRC's final rule promulgating fee schedules for fiscal
year 1999, not all materials licensees request amendments during a
given fiscal year. Over a 5-year period, approximately 80 percent
request at least one amendment, and approximately 40 percent request
multiple amendments. (64 FR 31460; June 10, 1999)
\4\ Compiled from estimates (in some cases covering a period of 5 or
more years of data) obtained from American Board of Radiology,
American Board of Nuclear Medicine, American Board of Medical
Physicists, Health Physics Society, Board of Pharmaceutical
Specialities and from personal communications with Barry Siegel, M.D.,
Mr. Mark Rotman, and NRC staff. Published sources include American
Board of Radiology, ABR Examiner, 2:1 (Examination Statistical Summary
1991-1996) and 4:1 (Examination Statistical Summary 1994-1998);
Society of Nuclear Medicine, Journal of Nuclear Medicine, Newsline:
The SNM Manpower Survey Report, 33:11 (November 1992), Newsline:
Future Nuclear Medicine Physician Requirements, 37:5 (May 1996), and
Newsline: Future of Nuclear Medicine, Part 3: Assessment of the U.S.
Therapeutic Radiopharmaceuticals Market (2001-2020), 39:7 (July 1998):
and The Official ABMS Directory of Board Certified Medical
Specialists, 1997 and 1999.
4.3 Current Uses of Byproduct Materials
Since 1946, growth in the medical applications of radioisotopes has
been very rapid as their usefulness has become more apparent in
diagnosis, therapy, and medical research. Current medical procedures
employ a number of radionuclides in a wide variety of chemical and
physical forms. Nuclear medicine procedures for diagnostic and
therapeutic applications involve the internal administration of
radiolabeled tracers. Administration of the radiolabeled tracers, known
as radiopharmaceuticals, may be performed by intravenous injection,
inhalation, or oral ingestion. In most cases, diagnostic nuclear
medicine involves imaging agents used for the delineation and
localization of organ tissues by scintigraphy (e.g., technetium-99m
hydroxymethylene diphosphonate used as a bone seeking
radiopharmaceutical). Organ function may be determined by quantifying
the accumulation of radiopharmaceuticals in organs of interest (e.g.,
iodine-131 uptake studies used to assess thyroid function). Therapeutic
nuclear medicine may use various radiopharmaceuticals for the treatment
of disease by selective absorption or concentration (e.g., iodine-131
used to treat thyroid cancer). Other therapeutic applications may
involve the use of radiopharmaceuticals in colloidal suspensions for
the treatment of malignant tumors (e.g., phosphate-32 infusion for
treatment of peritoneal or pleural effusions associated with malignant
tumors).
Since the early 1900s, radiation therapy has become one of the
major modalities of treatment in the management of neoplastic disease,
generally referred to as cancer. Radiation therapy may also be used as
a palliative agent in the medical treatment process. The objective of
conventional radiation therapy using a teletherapy sealed source is to
deliver a precisely measured dose of radiation to a defined tumor
volume. This is usually accomplished by delivering a dose in daily
increments over several weeks. External beam radiation therapy has
evolved using innovative technology that has led to the development of
the gamma stereotactic radiosurgery device used for treatment of
precisely defined intracranial targets (e.g., brain tumors and
arteriovenous malformations).
Brachytherapy uses a variety of smaller sealed sources for
localized treatment of cancer. Typically the sealed sources are either
inserted in a cavity (e.g., cesium-137 sources used for intracavitary
treatment of cervical cancer) or implanted in tissue (e.g., iodine-125
seeds used for interstitial treatment of prostate cancer). Various
remote afterloading devices have been developed for low, medium, and
high dose-rate brachytherapy treatments.
5.0 revisions to regulatory text and consequences
subpart a--general information
5.1 Purpose and scope (Sec. 35.1).
Section 35.1 currently provides that 10 CFR Part 35 contains
requirements for the medical use of byproduct material and for issuance
of specific licenses authorizing the medical use of this material.
These requirements and provisions provide for the protection of public
health and safety.
The final rule substitutes the words ``radiation safety of workers,
the general public, patients, and human research subjects'' for
``protection of the public health and safety.'' The final rule adds
Part 171 to the list of Parts that apply to applicants and licensees
subject to Part 35.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Provides improved clarity and precision as well as
consistency with revisions to the Medical Policy Statement.
5.2 Definitions (Sec. 35.2).
Section 35.2 sets out the applicable definitions for 10 CFR Part
35.
The final rule deletes the definitions of ``ALARA,'' ``Dental
use,'' ``Diagnostic clinical procedures manual,'' ``Mobile nuclear
medical service,'' ``Ministerial change,'' ``Misadministration,''
``Podiatric use,'' ``Recordable event,'' and ``Teletherapy physicist.''
The final rule revises the definitions of ``Area of use,''
``Authorized nuclear pharmacist,'' ``Authorized user,'' ``Brachytherapy
source,'' ``Management,'' ``Medical use,'' ``Output,'' ``Prescribed
dosage,'' ``Prescribed dose,'' ``Radiation Safety Officer,'' and
``Written directive.''
The final rule adds definitions for ``Authorized medical
physicist,'' ``Brachytherapy,'' ``Client's address,'' ``High dose-rate
remote afterloader,'' ``Low dose-rate remote afterloader,'' ``Manual
brachytherapy,'' ``Medical event,'' ``Medium dose-rate remote
afterloader,'' ``Mobile Medical service,'' ``Patient intervention,''
``Preceptor,'' ``Pulsed dose-rate remote afterloader,'' ``Sealed Source
and Device Registry,'' ``Stereotactic radiosurgery,'' ``Structured
educational program,'' ``Teletherapy,'' ``Temporary jobsite,''
``Therapeutic dosage,'' ``Therapeutic dose,'' ``Treatment site,''
``Type of use,'' and ``Unit dosage.''
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Provide improved clarity and precision.
5.3 Maintenance of records (Sec. 35.5).
Section 35.5 specifies that records required by Part 35 must be
legible throughout the retention period. It specifies that the record
may be the original, a reproduced copy, or a microform provided that
the copy or microform is authenticated by authorized personnel and the
microform is capable of providing a clear copy throughout the required
retention period. It also specifies that the record may be stored in
electronic media with the capability for producing legible, accurate,
and complete records during the required retention period. The final
rule revises the phrase ``Records such as letters, drawings,
specifications, must include all pertinent information . . . `` to read
``Records such as letters, drawings, and specifications . . . .''
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Improved clarity.
5.4 Provisions for the protection of human research subjects
(Sec. 35.6).
Section 35.6 provides that a licensee may conduct research
involving human subjects using byproduct material if requirements
specified in the section are met.
Section 35.6(a) of the final rule provides that a licensee may
conduct research involving human research subjects only if using the
byproduct materials specified on its license for the uses authorized on
its license.
Section 35.6(b) of the final rule requires that if the research is
conducted, funded, supported, or regulated by another Federal agency
that has implemented the Federal Policy for the Protection of Human
Subjects (Federal Policy), the licensee shall, before conducting
research, obtain review and approval of the research from an
``Institutional Review Board,'' as defined and described in the Federal
Policy and obtain ``informed consent,'' as defined and described in the
Federal Policy, from the human research subject.
Section 35.6(c) of the final rule requires that if the research is
not conducted, funded, supported, or regulated by another Federal
agency that has implemented the Federal Policy, the licensee shall,
before conducting research, apply for and receive a specific amendment
to its NRC medical use license. The amendment request must include a
written commitment that the licensee will, before conducting research,
obtain review and approval of the research from an ``Institutional
Review Board,'' as defined and described in the Federal Policy and
obtain ``informed consent,'' as defined and described in the Federal
Policy, from the research subject.
Section 35.6(d) of the final rule clarifies that nothing in this
section relieves licensees from complying with the other requirements
in Part 35 and that all relevant radiation safety provisions of Part 35
are applicable to research involving human subjects.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Improved clarity.
5.5 FDA, other Federal, and State requirements (Sec. 35.7).
Section 35.7 provides that nothing in Part 35 relieves a licensee
from complying with applicable FDA, other Federal, and State
requirements governing radioactive drugs or devices.
The final rule amends the section to provide that licensees are
required to comply with applicable FDA, other Federal, and State
requirements governing radioactive drugs or devices.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Improved clarity.
5.6 Information collection requirements: OMB approval (Sec. 35.8).
Section 35.8(a) specifies the OMB-approved information collection
requirements contained in 10 CFR Part 35, and specifies that OMB has
approved the information collection requirements in this 10 CFR Part
under control number 3150-0010.
The final rule changes section numbers in Sec. 35.8(b) to conform
with the final rule.
Section 35.8(c) of the final rule adds NRC Forms 313A and 313B to
the information collection approved under control number 3150-0120 for
Sec. 35.12.
The final rule deletes Sec. 35.8(d) referring to OMB control number
3150-0171, which covered the information collection requirements
contained in Sec. Sec. 35.32 and 35.33, which are eliminated in the
final rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change for restructuring of 10 CFR Part 35.
5.7 Implementation (Sec. 35.10).
The final rule adds a new section, Sec. 35.10, that provides
implementation schedules.
Section 35.10(a) requires licensees to implement the provisions in
10 CFR Part 35 on or before six months from publication of the final
rule.
Section 35.10(b) allows licensees currently exempted from a
provision in the current 10 CFR Part 35 to continue to be exempt under
the final regulations.
Section 35.10(c) provides that if a requirement in an existing
license condition differs from a requirement in the current 10 CFR Part
35, the requirements in Part 35 govern.
Section 35.10(d) requires licensees to continue to comply with any
license conditions that requires them to implement procedures required
by Sec. Sec. 35.610, 35.642, 35.643 and 35.645.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Provides licensees time to implement new requirements.
5.8 License required (Sec. 35.11).
Section 35.11(a) currently provides that a person may not
manufacture, produce, acquire, receive, possess, use, or transfer
byproduct material for medical use except in accordance with a specific
license issued by the Commission or an Agreement State, or as allowed
in paragraphs (b) or (c) of Sec. 35.11. Section 35.11(b) currently
specifies that an individual may receive, possess, use, or transfer
byproduct material in accordance with the regulations in 10 CFR Part 35
under the supervision of an authorized user, as specified in the
requirements on supervision in Sec. 35.25, unless prohibited by license
condition. Section 35.11(c) currently provides that an individual may
prepare unsealed byproduct material for medical use in accordance with
the regulations in Part 35 under the supervision of an authorized
nuclear pharmacist or authorized user as provided in Sec. 35.25, unless
prohibited by license condition.
Section 35.11(a) of the final rule provides that a person may
manufacture, produce, acquire, receive, possess, use, or transfer
byproduct material for medical use only in accordance with a specific
license or as allowed in Sec. Sec. 35.11(b)(1) or (b)(2) of this
section.
Section 35.11(b) of the final rule provides that a specific license
is not needed for an individual who receives, possesses, uses, or
transfers byproduct material in accordance with the regulations in this
chapter under the supervision of an authorized user as provided in
Sec. 35.27, unless prohibited by license condition, or for an
individual who prepares unsealed byproduct material for medical use in
accordance with the regulations in this chapter under the supervision
of an authorized nuclear pharmacist or authorized user as provided in
Sec. 35.27, unless prohibited by license condition. Section 35.11(b)(2)
incorporates the provisions currently included in Sec. 35.11(c).
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Improved clarity.
5.9 Application for license, amendment, or renewal (Sec. 35.12).
Section 35.12 of the current rule specifies the procedures for
license application, amendment, or renewal.
Section 35.12(a) currently specifies that if the application is for
medical use sited in a medical institution, only the institution's
management may apply. If the application is for medical use not sited
in a medical institution, any person may apply.
Sections 35.12(b) and (c) currently specify that an application for
medical use of byproduct material as described in the pertinent
sections of 10 CFR Part 35 must be made by filing Form NRC-313.
The final rule provides in Sec. 35.12(a) that the application must
be signed by the applicant's or licensee's management and eliminates
the reference to application by ``any person.''
In Sec. 35.12(b), the final rule adds a reference to Sec. 35.600,
which in the final rule addresses remote afterloader units and gamma
stereotactic radiosurgery units, and Sec. 35.1000, which in the final
rule addresses medical uses not covered by Sec. Sec. 35.100 through
35.600. Section 35.12(b)(2) of the final rule requires the submission
of procedures mandated by Sec. Sec. 35.610, 35.642, 35.643, and 35.645,
as applicable.
Section 35.12(c) specifies that a request for a license amendment
or renewal must be made by submitting an original and one copy in
letter format and submitting procedures required by Sec. Sec. 35.610,
35.642, 35.643, and 35.645, as applicable.
The final rule adds a new Sec. 35.12(d) that establishes
requirements for license applications for other medical uses of
byproduct material as described in Sec. 35.1000. Specifically,
Sec. 35.12(d) requires that, in addition to the information currently
required in Form NRC-313, ``Application for a Materials License,'' the
applicant must also supply the following:
<bullet> Any information regarding any radiation safety aspects of
the medical use of the material that is not addressed in Subparts A
through C of 10 CFR Part 35;
<bullet> Any specific information necessary for: (1) radiation
safety precautions and instructions; (2) methodology for measurement of
dosages or doses to be administered to patients or human research
subjects; and (3) calibration, maintenance, and repair of instruments
and equipment necessary for radiation safety.
<bullet> Any other information requested by the Commission in its
review of the application.
Cost Impacts: NRC intends for this provision to allow applicants
and licensees to submit license applications for medical uses not
specifically addressed in Subparts D-H of the final rule. Thus, license
applications for new or emerging technologies could be submitted under
Sec. 35.12(d) instead of requiring applicants or licensees to submit an
exemption request under Sec. 35.19. However, because of the nature of
emerging technologies, all of the information needed for approval of
such technologies cannot be specified in advance.
Cost savings may result for applicants or licensees from a
reduction in time to prepare applications for new or emerging
technologies not addressed in Subparts D-H compared to time necessary
to seek approval via an exemption.
Assumptions:
Licensees: Total annual licensee applications: 2; Reduced
application preparation time, hours: 4; Physician hourly rate \4\ $100;
Total Annual Cost Savings for licensees: $1,000 \5\; Total Annual Cost
Savings from amendment to Sec. 35.12(d): $1,000.
---------------------------------------------------------------------------
\4\ The regulatory analysis assumes the following hourly rates, by
labor category, fully loaded: RSO/Authorized User/Medical Physicist/
Physician/Administrator/Management: $100; Scientific Staff: $50;
Technical Staff: $30; Clerical Staff: $18.
\5\ Costs below $500 rounded down; costs at or above $500 rounded
up to nearest thousand.
---------------------------------------------------------------------------
Health and Safety Impacts: None anticipated.
Benefits: Cost savings to licensees.
5.10 License amendments (Sec. 35.13).
Section 35.13 currently specifies the circumstances under which a
licensee must apply for and receive a license amendment.
Section 35.13(b) currently requires a licensee to obtain a license
amendment before it permits anyone to work as an authorized user or
authorized nuclear pharmacist under the license, unless
<bullet> Under Sec. 35.13(b)(1) the authorized user is certified by
an organization specified in 10 CFR Part 35; or
<bullet> Under Sec. 35.13(b)(2) the authorized nuclear pharmacist
is certified by an organization specified in 10 CFR Part 35; or
<bullet> Under Sec. 35.13(b)(3) the person is identified as an
authorized user or authorized nuclear pharmacist on an NRC or Agreement
States license; or
<bullet> Under Sec. 35.13(b)(4) the person is identified as an
authorized user or authorized nuclear pharmacist on a permit issued by
an NRC or Agreement States specific licensee of broad scope.
Section 35.13(c) currently requires a licensee to obtain a license
amendment before it changes Radiation Safety Officers or Teletherapy
Physicists.
The final rule, in Sec. 35.13(b), requires a licensee to obtain a
license amendment before it permits anyone to work as an authorized
nuclear pharmacist, authorized user, or authorized medical physicist,
unless the individual meets specified conditions described in
paragraphs (b)(1) through (b)(4).
The final rule, in Sec. 35.13(c), continues to require a licensee
to obtain a license amendment before it changes Radiation Safety
Officers, except as provided in Sec. 35.24(c). The final rule also
amends Sec. 35.13(e), which requires a licensee to obtain a license
amendment before adding to or changing the areas of use. Specifically,
Sec. 35.13(e) of the final rule does not require licensees to submit a
license amendment for changes of area of use for medical uses permitted
under Sec. Sec. 35.100 and 35.200.
Cost Impacts: NRC anticipates cost savings to licensees and NRC
from a reduction in the number of license amendments that will be
submitted to NRC to add teletherapy physicists (changed to medical
physicists) to a license (Sec. 35.13(c)) and areas of use where
byproduct material is used in accordance with Sec. Sec. 35.100 or
35.200 (Sec. 35.13(e)).
Assumptions (Sec. 35.13(c)):
Licensees: License amendment applications \6\ (20 percent of 60
licensees need to apply for one amendment/year) \7\: 12; Physician/
management amendment preparation time, hours: 1; Physician/management
hourly rate: $100; Technical staff hours to prepare amendment: 4;
Technical staff hourly rate: $30; Total Annual Cost Savings for
licensees: $3,000.
---------------------------------------------------------------------------
\6\ The NRC license tracking system does not generate data on
license amendments by type of action requested. In addition, one
amendment application may include a request for several actions. The
estimated number of amendment applications per year therefore may
overstate the number of requests received. Estimates are based on
discussions with NRC Regional Staff and State personnel on the
regulatory working group.
\7\ The labor turnover rate in the U.S. economy averages
approximately 20 percent, as of March 2000. This rate may overstate
slightly the turnover rate for medical physicists.
---------------------------------------------------------------------------
NRC/Agreement States: \8\
---------------------------------------------------------------------------
\8\ NRC no longer charges a separate, per-amendment fee. The NRC
has amended 10 CFR 170.31 to eliminate the flat amendment fee for
materials licensees. (64 FR 31460; June 10, 1999). A labor rate of $75/
hour is used for NRC labor costs, which represents a partially loaded
blended rate of technical, clerical, and managerial staff. The $75/hour
labor rate also is used for Agreement States labor costs.
---------------------------------------------------------------------------
Total amendments: 12; NRC/Agreement States amendment review time,
hours: 4; NRC/Agreement States hourly rate: $75; Total Annual Cost
Savings for NRC and Agreement States: $4,000; Total Annual Cost Savings
from amendment to Sec. 35.13(c): $7,000.
NRC also anticipates cost savings to licensees and NRC or Agreement
States from a reduction in the number of license amendments that will
be submitted for changes in areas of use.
Assumptions (Sec. 35.13(e)):
Licensees: Total annual amendments for changes in areas of use: 510
\9\; Physician amendment preparation time, hours: 1; Physician hourly
rate: $100; Technical staff amendment preparation time, hours: 2;
Technical staff hourly rate: $30; Total Annual Cost Savings for
licensees: $82,000.
---------------------------------------------------------------------------
\9\ Assumes approximately 12.5 percent of all annual amendment
requests involve changes in areas of use for Sec. Sec. 35.100 and
35.200. Estimated based on Program Codes 2120, 2121, 2200, and 2201.
See Footnote 3 to Table 2.
---------------------------------------------------------------------------
NRC/Agreement States:
Total annual amendments for changes in areas of use: 510 \9\; NRC/
Agreement States amendment review time, hours: 2; NRC/Agreement States
hourly rate: $75; Total Annual Cost Savings for NRC and Agreement
States: $77,000; Total Annual Cost Savings for Sec. 35.13(e): $159,000;
Total Annual Cost Savings from Sec. 35.13: $166,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings to licensees, NRC, and Agreement States.
5.11 Notifications (Sec. 35.14).
Section 35.14(a) currently requires licensees to provide the
Commission with a copy of the board certification or the permit issued
by a licensee of broad scope for each individual who is allowed to work
as an authorized user or an authorized nuclear pharmacist. Section
35.14(b)(1) requires the licensee to notify the Commission by letter
when an authorized user, authorized nuclear pharmacist, Radiation
Safety Officer, or teletherapy physicist permanently discontinues
performance of duties under the license or has a name change.
The final rule amends Sec. Sec. 35.14(a) and (b)(1) to add
authorized medical physicist to the list of persons about whom the
licensee must notify the Commission while simultaneously deleting
teletherapy physicist from the list. The final rule, in Sec. 35.14(a),
adds permits issued by a Commission master material license broad scope
permittee. The final rule adds Sec. 35.14(b)(3) to clarify the
requirement concerning notice when the licensee's name changes; and
adds Sec. 35.14(b)(4) to require notification when the licensee has
added to or changed the areas of use identified in the application or
on the license and permitted under Sec. Sec. 35.100 or 35.200.
Cost Impacts: NRC anticipates a small cost increase as a result of
an increase in the number of notices that licensees will be required to
submit. Of those licensees employing a medical physicist (estimated at
about 617 licensees), about 20 percent are estimated to notify NRC or
Agreement States agencies at least one additional time per year.
Assumptions (Sec. 35.14(b)(1)):
Licensees: NRC/Agreement States licensee notifications pertaining
to medical physicists: 123; Annual licensee notification, hours: 0.5;
Technical staff hourly rate: $30; Total Annual Cost Increase for
licensees: $2,000.
NRC/Agreement States: NRC/Agreement States licensee notifications:
123; NRC/Agreement States review time: 0.25; NRC/Agreement States
hourly rate: $75; Total Annual Cost Increase for NRC and Agreement
States: $2,000; Total Annual Cost Increase for Sec. 35.14(b)(1):
$4,000.
NRC also anticipates a small cost increase as a result of requiring
licensees to report changes in the area of use. However, NRC estimates
only a small number of total annual applications will be due to changes
in license area of use (12.5 percent of 4080 annual license
notifications).
Assumptions (Sec. 35.14(b)(4)):
Licensees: Total annual notification of changes in licensee's areas
of use: 510; Notification preparation time, hours: 0.5; Technical staff
hourly rate: $30; Total Annual Cost Increase for licensees: $8,000.
NRC/Agreement States: Total annual notification of changes in
licensee's areas of use: 510; NRC/Agreement States review time, hours:
0.25; NRC/Agreement States hourly rate: $75; Total Annual Cost Increase
for NRC and Agreement States: $10,000; Total Annual Cost Increase for
Sec. 35.14(b)(4): $18,000; Total Annual Cost Increase for Sec. 35.14:
$22,000.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change with substitution of term ``medical
physicist'' for ``teletherapy physicist.'' Also, increased flexibility
and reduced regulatory burden for licensees are anticipated.
5.12 Exemptions regarding Type A specific licenses of broad scope
(Sec. 35.15).
Section 35.15(d) currently exempts a licensee possessing a Type A
specific license of broad scope for medical use from the provisions of
Sec. 35.14(b)(1) for an authorized user or an authorized nuclear
pharmacist.
The final rule amends Sec. Sec. 35.15(a) and (b) to authorize the
exemption of a licensee possessing a Type A specific license of broad
scope for medical use, issued under Part 33, from the provisions of
Sec. 35.12(d) regarding the need to file an amendment to the license
for medical uses of byproduct material, as described in Sec. 35.1000,
and the provisions of Sec. 35.13(b), respectively. Section 35.15(c)
exempts a licensee with Type A specific license of broad scope for
medical use from the provisions of Sec. 35.13(e) regarding additions to
or changes in the areas of use only at the addresses specified in the
application or on the license.
The final rule amends Sec. 35.15(d) to exempt a licensee with Type
A specific license of broad scope for medical use from the provisions
of Sec. 35.14(a).
The final rule adds new Sec. Sec. 35.15(e)-(g) to exempt Type A
license holders from the provisions of Sec. 35.14(b)(1) for an
authorized user, an authorized nuclear pharmacist, or an authorized
medical physicist; provisions of Sec. 35.14(b)(4) regarding additions
to or changes in the areas of use identified in the application or on
the license where byproduct material is used in accordance with
Sec. Sec. 35.100 or 35.200; and the provisions of Sec. 35.49(a).
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.13 License issuance (Sec. 35.18).
Section 35.18 currently specifies the requirements for license
issuance for use of byproduct material. Section 35.29 currently
specifies the requirements for licensing mobile nuclear medicine
services.
The final rule adds a new Sec. 35.18(b) providing that the
Commission will issue a license for mobile services if: (1) the
applicant meets the requirements specified in Sec. 35.18(a); and (2)
assures that individuals or human research subjects to whom byproduct
material or radiation from implants containing byproduct material will
be administered may be released following treatment in accordance with
Sec. 35.75.
Cost Impacts: No cost impacts are anticipated for licensees.
Section 35.29 has been eliminated and replaced with requirements in
final Sec. Sec. 35.18(b) and 35.80. The final rule promulgates, in
Sec. 35.18(b), a criterion currently being implemented through
licensing.
Health and Safety Impacts: None anticipated.
Benefits: If the amendment leads to an increase in the availability
of mobile services, patients could experience benefits as a result of
lessened travel to reach medical care.
5.14 Specific exemptions (Sec. 35.19).
Section 35.19 currently provides that the Commission may grant
exemptions from the 10 CFR Part 35 requirements. It states that the
Commission will review requests for exemptions from the training and
experience requirements with the assistance of the Advisory Committee
on the Medical Uses of Isotopes (ACMUI).
The final rule eliminates the reference to assistance from the
ACMUI. NRC anticipates, however, that the Commission will continue to
review such exemption requests with the assistance of ACMUI.
Cost Impacts: No cost impacts are anticipated because the only
change is the elimination of the reference to assistance from the
ACMUI.
Health and Safety Impacts: None anticipated.
Benefits: The current text regarding the ACMUI is a Commission
policy position and is not a regulatory requirement. Therefore, this
text was removed for improved clarity.
subpart b--general administrative requirements
5.15 ALARA program (Sec. 35.20).
Section 35.20 currently requires that licensees develop and
implement a written radiation protection program that includes
provisions for keeping doses as low as reasonably achievable (ALARA)
and specifies program content and participants.
The final rule eliminates Sec. 35.20.
Cost Impacts: None anticipated. NRC considers the requirements of
10 CFR Part 20, particularly 10 CFR 20.1101, to be commensurate with
the scope and extent of 10 CFR Part 35 ALARA requirements.
Specifically, 10 CFR 20.1101 requires licensees to develop, document,
and implement a radiation protection program and includes ALARA
requirements. This is comparable to 10 CFR Part 35, where licensees are
required to develop an ALARA program for activities conducted under 10
CFR Part 35.
In the final rule, the current ALARA requirements in Sec. 35.20 are
unnecessary, given a performance-based approach, because ALARA is
already required under 10 CFR 20.1101. However, no costs will be
avoided in the final rule because licensees are still required by 10
CFR Part 20 to keep doses as low as reasonably achievable.
Health and Safety Impacts: None anticipated because 10 CFR Part 20
continues to require an ALARA program.
Benefits: Eliminates the prescriptive requirements in Sec. 35.20
and provides licensees with greater flexibility regarding ALARA
programs.
5.16 Radiation Safety Officer (Sec. 35.21).
Section 35.21 currently requires that each licensee appoint a
Radiation Safety Officer (RSO).
Section 35.21(a) requires each licensee to appoint an RSO who is
responsible for implementing the radiation safety program. The
licensee, through the RSO, ensures compliance with the radiation safety
program.
Section 35.21(b) specifies the duties and responsibilities of the
RSO.
The final rule eliminates Sec. 35.21 and replaces it in 10 CFR Part
35 with Sec. 35.24, which addresses the authority and responsibilities
for the radiation protection program, including specific requirements
regarding the RSOs.
Cost Impacts: Cost impacts are evaluated under Sec. 35.24.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.21 because Sec. 35.24
specifically addresses requirements regarding the RSO.
Benefits: Conforming change to restructuring of 10 CFR Part 35 to
be more performance-based.
5.17 Elimination of Sec. 35.22 of the Current Rule (Radiation Safety
Committee).
Section 35.22 currently requires that each medical institution
licensee establish a Radiation Safety Committee (RSC) to oversee the
use of byproduct material. Section 35.22(a) specifies the required
membership of the RSC, meeting frequency, criteria for a quorum,
content of minutes, distribution of minutes and the required retention
period of minutes. Section 35.32(b) requires the RSC to perform
specific reviews.
The final rule eliminates Sec. 35.22, and replaces it with a new
Sec. 35.24, which addresses the authority and responsibilities for the
radiation protection program, including a requirement (Sec. 35.24(f))
that licensees that are authorized for two or more different types of
uses of byproduct material under Subparts E, F, and H, or two or more
types of units under Subpart H must establish a Radiation Safety
Committee to oversee all uses of byproduct material permitted by the
license. The Committee must include an authorized user of each type of
use permitted by the license, the Radiation Safety Officer, a
representative of the nursing service, and a representative of
management who is neither an authorized user nor a Radiation Safety
Officer. The Committee may include other members whom the licensee
considers appropriate.
Cost Impacts: The elimination of Sec. 35.22 results in significant
cost savings for certain categories of licensees because of the
deletion of the requirement to hold quarterly Radiation Safety
Committee meetings. The impacts of the elimination of Sec. 35.22 and
its replacement by Sec. 35.24 are described under Sec. 35.24.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.22 because Sec. 35.24
incorporates requirements for coordination of the radiation safety
program.
Benefits: Significant cost savings to licensees as well as greater
flexibility to licensees in coordinating radiation safety activities.
5.18 Statements of authority and responsibility (Sec. 35.23).
Section 35.23(a) currently requires that each licensee provide
Radiation Safety Officers and Radiation Safety Committees sufficient
authority to fulfill their duties and responsibilities. Section
35.23(b) requires the licensee to establish those authorities, duties,
and responsibilities in writing and to retain the current edition as a
record until the Commission terminates the license.
The final rule eliminates Sec. 35.23, and replaces it with a new
section, Sec. 35.24, which specifies requirements for the radiation
protection program, including written authorities, duties, and
responsibilities of the RSO (Sec. 35.24(e)).
Cost Impacts: Cost impacts are evaluated under Sec. 35.24.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.23, because Sec. 35.24
incorporates requirements for written statements of authorities,
duties, and responsibilities of the RSO.
Benefits: Conforming change to restructuring of 10 CFR Part 35 to
be more performance-based.
5.19 Authority and responsibilities for the radiation protection
program (Sec. 35.24).
The final rule contains a new section, Sec. 35.24, specifying
authority and responsibility for the radiation protection program.
Section 35.24(a) provides that, in addition to the radiation
protection program requirements of 10 CFR 20.1101, a licensee's
management must approve: (1) requests for license application, renewal,
or amendment before submittal; (2) any individual, before allowing that
individual to work as an authorized user, authorized nuclear
pharmacist, or authorized medical physicist; and (3) radiation
protection program changes that do not require a license amendment and
are permitted under Sec. 35.26.
Section 35.24(b) requires a licensee's management to appoint an RSO
who agrees in writing to be responsible for implementing the radiation
protection program. The licensee, through the RSO, shall ensure that
the licensee's radiation safety activities are being performed in
accordance with the licensee-approved procedures and regulatory
requirements.
Section 35.24(c) authorizes a licensee to permit, for up to 60 days
each year, an authorized user or an individual qualified to be a
Radiation Safety Officer to function as a temporary Radiation Safety
Officer and to perform the functions of a Radiation Safety Officer, as
provided in Sec. 35.24(g), if the licensee takes the actions required
in paragraphs (b), (e), (g), and (h) of Sec. 35.24.
Section 35.24(d) allows a licensee to simultaneously appoint more
than one temporary Radiation Safety Officer in accordance with
paragraph (c), if needed to ensure that the licensee has a temporary
Radiation Safety Officer that satisfies the requirements to be a
Radiation Safety Officer for each of the different uses of byproduct
material permitted by the license.
Section 35.24(e) requires licensees to establish in writing the
authority, duty, and responsibilities of the RSO.
Section 35.24(f) requires licensees that are authorized for two or
more types of byproduct material under Subparts E, F, and H or two or
more units under Subpart H, to establish a Radiation Safety Committee
to oversee all uses of byproduct material permitted by the license. The
Committee must include an authorized user of each type of use permitted
by the license, the Radiation Safety Officer, a representative of the
nursing service, and a representative of management who is neither an
authorized user nor a Radiation Safety Officer. The Committee may
include other members whom the licensee considers appropriate.
Section 35.24(g) requires licensees to provide the RSO sufficient
authority, organizational freedom, time, resources, and management
prerogative to fulfill their duties to identify radiation safety
problems; initiate, recommend, or provide corrective actions; stop
unsafe operations; and verify implementation of corrective actions.
Section 35.24(h) requires recordkeeping under paragraphs (a), (b)
and (e) in accordance with new Sec. 35.2024.
Cost Impacts: No cost impacts are anticipated from Sec. 35.24(a),
because licensees continue to be allowed to make changes to their
radiation protection program, as currently allowed by Sec. 35.31.
Minimal cost impacts are anticipated from the requirement in
Sec. 35.24(b) that the RSO must agree in writing to perform the duties
of RSO. The RSO is required to perform a prescriptive list of duties in
the current rule, Sec. 35.21. This change will allow greater
flexibility.
Minimal cost savings are anticipated from the provisions in
Sec. 35.24(c) and (d) that a licensee may appoint multiple temporary
RSOs. Greater flexibility will be provided to licensees.
There are no cost impacts from the requirement in Sec. 35.24(e)
that a licensee establish the authority, duties, and responsibilities
of the RSO in writing because this requirement is carried over from the
current rule, Sec. 35.23.
Cost savings to licensees are anticipated from the provision in
Sec. 35.24(f) that only licensees that are licensed for two or more
different uses of byproduct material under Subparts E, F, and H or two
or more types of units under Subpart H must establish a Radiation
Safety Committee. Licensees under Subparts D and G that use only
unsealed byproduct material for which a written directive is not
required are not required to have a Radiation Safety Committee. In
addition, Sec. 35.24(f) eliminates prescriptive requirements in
Sec. Sec. 35.22(a)(2) and (3) of the current rule requiring meetings to
be held at least quarterly, specifying what constitutes a quorum,
specifying the contents of minutes, and specifying in detail the
required activities of the Radiation Safety Committee.
NRC estimates that about 20 percent of medical institutions will
not be required to have Radiation Safety Committees. In addition, NRC
estimates that the costs of Radiation Safety Committees to those
licensees that are required to maintain them will be reduced by 10
percent under the final rule.
The costs associated with Sec. 35.24(f) are estimated as follows:
Assumptions:
Licensees not required to set up RSCs: Total licensee meetings
eliminated annually: 3,010; Persons responsible for coordination: 4;
Time saved per meeting eliminated, hours: 2; Combined staff hourly rate
(medical, scientific, technical): $75; Total Annual Cost Savings from
meetings eliminated by Sec. 35.24(f): $1,806,000.
Licensees required to set up RSCs: Total licensee meetings
annually: 12,040; Persons responsible for coordination: 4; Reduced time
required per meeting, hours: 0.1; Combined staff hourly rate (medical,
scientific, technical): $75; Total Annual Cost Savings from reduced
requirements under Sec. 35.24(f): $361,000; Total Annual Cost Savings
from elimination of Sec. 35.22 by Sec. 35.24(f): $2,167,000.
No cost impacts are anticipated from the new Sec. Sec. 35.24(c),
(d), and (e), because they continue to specify duties and
responsibilities of Radiation Safety Officers.
Health and Safety Impacts: No health and safety impacts are
anticipated from the new Sec. Sec. 35.24(c), (d), and (e) because they
continue to specify duties and responsibilities of Radiation Safety
Officers. No health or safety impacts are anticipated under
Sec. 35.24(f) because Subpart E, F, and H licensees continue to be
required to have Radiation Safety Committees.
Benefits: Provides greater flexibility to licensees.
5.20 Radiation protection program changes (Sec. 35.26).
Section 35.31(a) currently allows licensees to make minor changes
to their radiation safety procedures that do not impact safety, and
lists examples of such changes. Section 35.31(b) requires records of
such changes to be kept until the license is renewed or terminated, and
specifies that changes must be signed by the Radiation Safety Officer,
the affected authorized user(s), and the licensee's management or in
medical institutions, the chairman of the Radiation Safety Committee
and the management representative.
The final rule renumbers Sec. 35.31 as Sec. 35.26 and makes the
following changes:
Section 35.26(a) allows licensees to revise their radiation
protection program without Commission approval, provided the change:
(1) does not require an amendment under Sec. 35.13; (2) is in
compliance with the regulations and the license; and (3) has been
reviewed and approved by the RSO and licensee management, and provided
that affected individuals are instructed on the revised program before
the changes are implemented. Also, Sec. 35.26(a) eliminates the
examples of ministerial changes previously listed in Sec. 35.31(a).
Section 35.26(b) requires the licensee to maintain a record of each
change in accordance with Sec. 35.2026.
Cost Impacts: On balance, cost savings are anticipated from the
final rule.
Assumptions:
Licensees: Total licensees: 5,793; Net reduction in time, hours:
0.08; Technical staff hourly rate: $30; Total Annual Cost Savings from
Sec. 35.26: $14,000.
Health and Safety Impacts: No health and safety impacts are
anticipated from the changes to Sec. 35.26.
Benefits: Cost savings to licensees.
5.21 Supervision (Sec. 35.27).
Section 35.25(a) currently requires that each licensee permitting
an individual to use byproduct material under the supervision of an
authorized user must: (1) instruct the supervised individual in
radiation safety and the licensee's written quality management program;
(2) require the supervised individual to follow the instructions of the
authorized user, follow radiation safety and quality management
procedures and comply with regulations and license conditions; and (3)
periodically review the supervised individual's use of byproduct
material and records kept to reflect that use.
Section 35.25(b) currently requires that each licensee permitting
preparation of byproduct material for medical use by an individual
under the supervision of an authorized nuclear pharmacist or a
physician who is an authorized user, must: (1) instruct the supervised
individual in preparation of byproduct material for medical use,
radiation safety, and the licensee's quality management program; (2)
require the supervised individual to follow certain instructions, and
to comply with the regulations and license conditions; and (3)
periodically review the work of the supervised individual and the
records kept to reflect that work.
The final rule renumbers Sec. 35.25 as Sec. 35.27 and makes the
following changes:
Section 35.27(a) requires a licensee that permits the receipt,
possession, use, or transfer of byproduct material by an individual
under the supervision of an authorized user or as allowed by
Sec. 35.11(b)(1), in addition to the requirements in Sec. 19.12, to
instruct the supervised individual in the licensee's written radiation
protection procedures, written directive procedures, regulations of
this chapter, and license conditions with respect to the use of
byproduct material; and to require the supervised individual to follow
the instructions of the supervising authorized user for medical uses of
byproduct material, written radiation protection procedures established
by the licensee, written directive procedures, regulations, and license
conditions with respect to the medical use of byproduct material. The
final rule deletes references to the licensee's quality management
program. The final rule eliminates the requirement to instruct the
supervised individual in the licensee's written quality management
program and to periodically review the supervised individual's use of
byproduct material and records.
Section 35.27(b) requires a licensee that permits the preparation
of byproduct material for medical use by an individual under the
supervision of an authorized nuclear pharmacist or physician who is an
authorized user, as allowed by Sec. 35.11(b)(2) in addition to the
requirements in Sec. 19.12, to instruct the supervised individual in
the preparation of byproduct material for medical use, as appropriate
to that individual's involvement with byproduct material; and to
require the supervised individual to follow the instructions of the
supervising authorized user or authorized nuclear pharmacist regarding
the preparation of byproduct material for medical use, the written
radiation protection procedures established by the licensee and the
regulations of this chapter, and license conditions. The final rule
eliminates the requirement to instruct the supervised individual in the
licensee's written quality management program and to periodically
review the individual's work as it pertains to preparing byproduct
material for medical use and records kept to reflect that work.
Section 35.27(c) requires that a licensee that permits supervised
activities under Sec. Sec. 35.27 (a) and (b) be responsible for the
acts and omissions of the supervised individual.
Cost Impacts: Increased costs are anticipated by requiring
licensees to instruct the supervised individual on the regulations and
license conditions.
Assumptions:
Licensees: Total NRC/Agreement States licensees: 5,793; Authorized
user instruction time, hours: 2; Authorized user hourly rate: $100;
Total Cost Increase for Sec. 35.27(a)(1): $1,159,000.
Decreased costs are anticipated by Sec. 35.27(b) no longer
requiring licensees to conduct periodic reviews of supervised
individuals' work and records.
Assumptions (elimination of periodic reviews):
Licensees: Total NRC/Agreement States licensees: 5,793; Authorized
user periodic review time (quarterly reviews), hours: 4; Authorized
user hourly rate: $100; Total Annual Cost Savings for Sec. 35.27(b):
$2,317,000; Total Annual Cost Savings from Sec. 35.27: $1,158,000.
Health and Safety Impacts: Increased radiation safety.
Benefits: Cost savings and increased flexibility for licensees.
5.22 Administrative requirements that apply to the provision of mobile
nuclear medicine service (Sec. 35.29).
Section 35.29 currently specifies the requirements for licensing
mobile nuclear medicine service licensees.
The final rule eliminates Sec. 35.29, and replaces it with
requirements in final Sec. Sec. 35.18(b) and 35.80.
Cost Impacts: Cost impacts are addressed under Sec. Sec. 35.18(b)
and 35.80 of the final rule.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.29 because administrative
requirements for mobile nuclear medicine services continue to be
addressed under the final Sec. Sec. 35.18(b) and 35.80.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.23 Quality Management Program (Sec. 35.32).
Section 35.32 currently requires each licensee to establish and
maintain a written quality management program (QMP).
Section 35.32(a) requires that the quality management program must
include procedures for preparing written directives for teletherapy,
gamma stereotactic radiosurgery, brachytherapy, administrations of
sodium iodide I-125 or I-131 in quantities greater than 30 microcuries,
and therapeutic administrations of a radiopharmaceutical other than
sodium iodide I-125 or I-131; verifying the patient's identity by more
than one method; ensuring that each administration is in accordance
with the written directive and any unintended deviation from the
written directive is identified and evaluated and appropriate action is
taken.
Section 35.32(b) requires that the licensee must develop procedures
for and conduct a review of the quality management program at least
annually.
Section 35.32(c) requires evaluation and response to each
recordable event.
Section 35.32(d) provides for retention of specified records.
Section 35.32(e) permits licensees to make certain modifications to
the quality management program. These changes are required to be
submitted to the NRC.
Section 35.32(f) requires each applicant for a new license to
submit a quality management program.
The final rule eliminates Sec. 35.32. The final regulations in
Sec. Sec. 35.40 and 35.41 establish requirements for written directives
and procedures to be followed for administrations requiring a written
directive. This change results in significant cost saving to medical
use licensees as compared to the current Sec. 35.32.
Cost Impacts: The deletion of Sec. 35.32 results in significant
cost savings.
Assumptions (elimination of Sec. 35.32(b)):
Licensees: Total affected licensees: 3,165; Hours for annual
licensee QMP review/recordkeeping: 14; Authorized user hourly rate:
$100; Total Annual Cost Savings for licensees: $4,431,000.
NRC/Agreement States (elimination of Sec. 35.32(f)): NRC/Agreement
States review of each licensee's QMP review: 8; NRC/Agreement States
staff hourly rate: $75; Total Annual Cost Savings for NRC and Agreement
States: $1,899,000.
Each applicable licensee is currently required by Sec. 35.32(c) to
evaluate and respond to each recordable event, including retaining
records of the event for 3 years. The analysis assumes 80 annual events
for which technical staff address the provisions of Sec. 35.32(c).
Assumptions (elimination of Sec. 35.32(c)):
Licensees: Annual number of recordable events: 80; Licensee
response time, hours: 2; Technical staff hourly rate: $30; Total Annual
Cost Savings for licensees: $5,000; Total Annual Cost Savings from
elimination of Sec. 35.32(c) for licensees and NRC and Agreement
States: $6,335,000.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.32 because Sec. 35.40 retains
requirements for written directives and Sec. 35.41 retains requirements
for procedures requiring a written directive.
Benefits: Cost savings to licensees.
5.24 Notifications, reports, and records of misadministrations
(Sec. 35.33).
Section 35.33 currently requires that each licensee notify NRC, by
phone, no later than the next calendar day, when a
``misadministration'' occurs; notify the referring physician and also
notify the individual receiving the misadministration within 24 hours
(unless the referring physician personally informs the licensee that he
will inform the individual or that, based on medical judgment, telling
the individual be harmful); and submit a written report to NRC and the
individual notified within 15 days. Section 35.33 requires records of
misadministrations to be retained for 5 years.
The final rule eliminates Sec. 35.33. Requirements for reporting
``medical events'' are established by the final rule under
Sec. 35.3045. Section 35.2 defines ``medical event'' as an event that
meets the criteria of Sec. 35.3045(a). Section 35.3045(a) of the final
rule, a new section, revises the requirements in Sec. 35.33 of the
current rule. Section 35.3045(a) replaces the word
``misadministration'' with ``medical event'' and makes other changes
defining the situations in which reports must be made. However, the
changes in Sec. 35.3045 are not expected to change the number or type
of medical events that are reported under Sec. 35.3045 substantially
from the number and type of misadministrations reported under the
current rule.
Cost Impacts: Cost impacts are evaluated under Sec. 35.3045.
Health and Safety Impacts: No health and safety impacts are
anticipated from elimination of Sec. 35.33 because Sec. 35.3045
essentially maintains reporting requirements for medical events.
Benefits: Conforming change to restructuring of 10 CFR Part 35 to
be more performance-based.
5.25 Written directives (Sec. 35.40).
The final rule adds a new Sec. 35.40(a) providing that a written
directive must be dated and signed by the authorized user before the
administration of I-131 sodium iodide greater than 1.11 Megabequerels
(MBq), any therapeutic dosage of unsealed byproduct material, or any
therapeutic dose of radiation from byproduct material.
Section 35.40(b) specifies that the written directive must contain
the name of the patient or human research subject and the following
information: for any administration of quantities greater than 1.11 MBq
of sodium iodide I-131: the dosage; for an administration of a
therapeutic dosage of unsealed byproduct material other than sodium
iodide I-131: the radioactive drug, dosage, and route of
administration; for gamma stereotactic radiosurgery: the total dose,
treatment site, and number of target coordinate settings per treatment
for each anatomically distinct treatment site; for teletherapy: the
total dose, dose per fraction, number of fractions, and treatment site;
for high dose-rate remote afterloading brachytherapy: the radionuclide,
treatment site, dose per fraction, number of fractions, and total dose;
and for all other brachytherapy, including low, medium, and pulsed
dose-rate remote afterloaders: before implantation: treatment site, the
radionuclide, and dose, and after implantation but before completion of
the procedure: the radionuclide, treatment site, number of sources, and
total source strength and exposure time (or the total dose).
Section 35.40(c) provides that a written revision to an existing
written directive may be made if the revision is dated and signed by an
authorized user before the administration of the dosage of unsealed
byproduct material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
If, because of the patient's condition, a delay in order to provide a
written revision to an existing written directive would jeopardize the
patient's health, an oral revision to an existing written directive is
acceptable. A revised written directive must be signed by the
authorized user within 48 hours of the oral revision.
Section 35.40(d) specifies that the licensee must retain the
written directive in accordance with Sec. 35.2040 of the final rule.
Cost Impacts: No costs are either avoided or increased for
licensees, Agreement States, or NRC because Sec. 35.40 essentially
retains the requirements in the current Sec. 35.32(a) regarding written
directives.
Health and Safety Impacts: None anticipated.
Benefits: Reduced regulatory burden to licensees compared to the
current Sec. 35.32 Quality Management Program, while maintaining an
adequate level of health and safety.
5.26 Procedures for administrations requiring a written directive
(Sec. 35.41).
The final rule adds a new Sec. 35.41. Section 35.41(a) requires for
any administration requiring a written directive that the licensee must
develop, implement, and maintain written procedures to provide high
confidence that before each administration the patient's identity is
verified and that each administration is in accordance with the written
directive. Section 35.41(b) specifies that the contents of the
procedures must include: (1) verifying the identity of the patient or
human research subject; (2) verifying that the administration is in
accordance with the treatment plan, if applicable, and written
directive; (3) checking both manual and computer-generated dose
calculations; and (4) verifying that any computer-generated dose
calculations are correctly transferred into the consoles of therapeutic
medical units authorized by Sec. 35.600. Section 35.41(c) requires that
a licensee retain a copy of the procedures required under Sec. 35.41(a)
in accordance with Sec. 35.2041.
Cost Impacts: No costs are either avoided or increased for
licensees, Agreement States, or NRC because the current Sec. 35.32(a)
requires licensees to have procedures in place to provide high
confidence that administrations of byproduct material or radiation from
byproduct material are as directed by the authorized user. The cost
avoided by eliminating reviews and recordkeeping associated with these
procedures is addressed under Sec. 35.32.
Health and Safety: None anticipated.
Benefits: Reduced regulatory burden to licensees compared to the
current Sec. 35.32 Quality Management Program (i.e., flexibility in
program management), while maintaining an adequate level of health and
safety.
5.27 Suppliers for sealed sources or devices for medical use
(Sec. 35.49).
Section 35.49 currently provides that a licensee may use for
medical use only: (a) sealed sources or devices manufactured, labeled,
packaged, and distributed in accordance with a license issued pursuant
to 10 CFR Part 30 and Sec. 32.74 or the equivalent requirements of an
Agreement State; or (b) teletherapy sources manufactured and
distributed in accordance with a license issued pursuant to 10 CFR Part
30 or the equivalent requirements of an Agreement State.
The final rule amends the text of Sec. 35.49 to provide that for
medical use, a licensee also may use sealed sources or devices
noncommercially transferred from a Part 35 licensee.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Greater clarity concerning the sealed sources and devices
that may be used for medical uses.
5.28 Training for Radiation Safety Officer (Sec. 35.50).
The current rule, in Sec. 35.900, specifies the training
requirements for a Radiation Safety Officer.
Section 35.900(a) lists nine specialist boards through which an
individual may become certified to be an RSO.
Alternatively, Sec. 35.900(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
nine listed speciality boards. It currently requires 200 hours of
classroom and laboratory training in specified subjects. In addition,
it requires 1 year of full time experience as a radiation safety
technologist at a medical institution under the supervision of the RSO.
Alternatively, Sec. 35.900(c) allows an individual to be the
Radiation Safety Officer if the individual is an authorized user
identified on the licensee's license.
The final rule renumbers Sec. 35.900 as Sec. 35.50 and makes the
following changes:
The list of nine approved speciality boards is eliminated. Section
35.50(a) provides instead that the licensee shall require an individual
fulfilling the responsibilities of the RSO to be certified by a
speciality board whose certification process includes all of the
requirements in Sec. 35.50(b) and whose certification has been
recognized by the Commission or an Agreement State.
Alternatively, under Sec. 35.50(b) the individual is required to
have completed: (1) a structured educational program consisting of 200
hours of didactic training in specified areas; and (2) 1 year of full
time radiation safety experience under the supervision of an individual
identified as the RSO on a Commission or Agreement State license that
authorizes similar types of use(s) of byproduct material involving
specified experience. Also, the individual must obtain written
certification, signed by a preceptor RSO, that the individual has
completed the required training and the individual has achieved a level
of radiation safety knowledge sufficient to function independently as
an RSO for a medical use license.
Alternatively, under Sec. 35.50(c), the individual is required to
be an authorized user, an authorized medical physicist or authorized
nuclear pharmacist identified on the licensee's license and to have
experience with the radiation safety aspects of similar types of use of
byproduct material for which the individual has RSO responsibilities.
Cost Impacts: The cost impacts associated with this section involve
additional costs to NRC/Agreement States for recognition of certifying
specialty boards, to certifying boards for preparing materials
supporting their recognition, and to some licensees and individuals
seeking to be an RSO for the cost of preceptor certification. NRC
estimates that approximately 190 individuals will seek to become
Radiation Safety Officers under Sec. 35.50 annually. Of these, 90
percent, or 171, will seek certification by a certifying board under
Sec. 35.50(a). No additional cost impacts be created for them under the
final rule. NRC estimates that the remainder, or approximately 19
individuals, will seek to become Radiation Safety Officers under
Sec. 35.50(b). New costs for securing a preceptor statement are created
by the final rule.
Under Sec. 35.50(a), NRC/Agreement States incur costs for
recognizing specialty boards for purposes of Sec. 35.50(a). NRC
estimates that recognition by NRC/Agreement States of specialty boards
for certification requires four hours per board and that NRC/Agreement
States will be required to review five boards for approval. \10\
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\10\ NRC will allow medical certifying boards to submit one
application for recognition that addresses every training and
experience section of the final rule for which they believe the board's
diplomates should be deemed to meet the requirements. However, the
number of boards that are estimated to seek recognition under each
training and experience section in this analysis reflects the
assumption that while some boards will submit one application for
multiple sections, boards also may choose to prepare more that one
application when the training and experience requirements for the
different sections for which they are applying are significantly
different.
---------------------------------------------------------------------------
Assumptions:
NRC/Agreement States: Number of boards reviewed: 5; NRC/Agreement
States review time: 4 hours/board at $75 per hour; Total Cost Increase:
$2,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards seeking recognition: 5;
Preparation of submission:12 hours/board for Technical Staff at $30/
hour; 4 hours/board for Management at $100/hour; Total Cost Increase
for Certifying Boards: $4,000; Total Cost Increase for Sec. 35.50(a):
$6,000.
Under Sec. 35.50(b), licensees and preceptors incur costs
associated with securing a preceptor's certification for purposes of
Sec. 35.50(b).
Assumptions:
Licensees: Number of candidates: 19; Cost of preceptor
certification: \1/2\ hour at $20 hour for candidate \11\ plus \1/2\
hour at $100/hour for preceptor; Total Cost Increase for Sec. 35.50(b):
$1,000; Total Cost Increase for Sec. 35.50: $7,000.
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\11\ Candidate's time measured at $20 per hour based on an
individual's estimated annual salary of $30,000 to $40,000.
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Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.29 Training for authorized medical physicist (Sec. 35.51).
The current rule, in Sec. 35.961, specifies the training
requirements for a teletherapy physicist.
Section 35.961(a) and (b) each list one specialist board through
which an individual may become certified.
Alternatively, Sec. 35.961(c) specifies training and experience
requirements that may be met in lieu of certification by one of the
listed speciality boards. It currently requires holding a master's or
doctor's degree in one of four areas. In addition, 1 year of full time
training in therapeutic radiological physics followed by 1 year of full
time work experience under the supervision of a teletherapy physicist
at a medical institution that includes performing specified tasks is
required.
The final rule renumbers Sec. 35.961 as Sec. 35.51, changes
``teletherapy physicist'' to ``authorized medical physicist,'' and
makes the following additional changes:
The list of two approved speciality boards is eliminated. Section
35.51(a) provides that the licensee shall require the authorized
medical physicist to be an individual who is certified by a specialty
board whose certification process includes all of the training and
experience requirements in Sec. 35.51(b) and whose certification has
been recognized by the Commission or an Agreement State.
Alternatively, Sec. 35.51(b)(1) adds ``medical physics'' to the
list of degrees approved by NRC. Section 35.51(b)(1) continues to
require 1 year of full time training in therapeutic radiological
physics followed by 1 year of full time work experience but adds to the
list of specified tasks that must be performed under supervision of an
individual who meets the requirements for an authorized medical
physicist at a medical institution that includes the tasks listed in
Sec. 35.67, 35.433, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, and
35.652, as applicable.
Section 35.51(b)(2) adds a requirement that the candidate medical
physicist must obtain written certification, signed by a preceptor
authorized medical physicist, that the training has been satisfactorily
completed and that the individual has achieved a level of competency
sufficient to function independently as an authorized medical
physicist.
Cost Impacts: The cost impacts associated with this section involve
additional costs to NRC/Agreement States to recognize certifying
specialty boards, to certification boards for preparing materials
supporting their recognition, and to some licensees and individuals
seeking to be an authorized medical physicist for the cost of preceptor
certification.
NRC estimates that approximately 100 physicists will seek to become
authorized medical physicists under Sec. 35.51 or equivalent Agreement
State regulations annually. Of these, 90 percent, or 90, will seek
certification by a certifying board under Sec. 35.51(a). No additional
cost impacts will be created for them under the final rule. NRC
estimates that the remainder, or approximately 10 physicists, will seek
to become authorized medical physicists under Sec. 35.51(b). New costs
for securing a preceptor statement are created by the final rule.
NRC estimates that approval by NRC/Agreement States of specialty
boards for certification for purposes of Sec. 35.51(a) will require
four hours per board and that NRC/Agreement States will be required to
review two boards for recognition. The costs to NRC/Agreement States
for certifying specialty boards are estimated below.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 2; NRC/Agreement
States review time: 4 hours/board at $75 per hour; Total Cost Increase:
$1,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards reviewed: 2; Preparation of
submission: 12 hours/board for Technical Staff at $30/hour; 4 hours/
board for Management at $100/hour; Total Cost Increase for Certifying
Boards: $2,000; Total Cost Increase for Sec. 35.51(a): $3,000.
The costs to licensees and preceptors associated with securing a
preceptor's certification for purposes of Sec. 35.51(b) are estimated
below.
Assumptions:
Licensees: Number of candidates: 10; Cost of preceptor
certification: \1/2\ hour at $20/hour for candidate plus \1/2\ hour at
$100/hour for preceptor; Total Cost Increase for Sec. 35.51(b):
<$1,000; Total Cost Increase for Sec. 35.51: $3,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.30 Training for an authorized nuclear pharmacist (Sec. 35.55).
The current rule, in Sec. 35.980, specifies the training
requirements for an authorized nuclear pharmacist.
Section 35.980(a) lists one specialist board through which an
individual may become certified to perform these procedures.
Alternatively, Sec. 35.980(b)(1) specifies training and experience
requirements that may be met in lieu of certification by the listed
speciality board. It currently requires 700 hours of classroom and
laboratory training in specified subjects as well as supervised
experience in specified tasks.
Section 35.980(b)(2) requires that the candidate pharmacist must
obtain written certification, signed by a preceptor authorized nuclear
pharmacist, that the training has been completed and the individual has
achieved a level of competency sufficient to independently operate a
nuclear pharmacy.
The final rule renumbers Sec. 35.980 as Sec. 35.55 and makes the
following changes:
The listing of approved speciality boards is eliminated. Section
35.55(a) provides instead that the licensee shall require the
authorized nuclear pharmacist to be a pharmacist who is certified as a
nuclear pharmacist by a speciality board whose certification process
includes all of the requirements in Sec. 35.55(b) and whose
certification has been recognized by the Commission or an Agreement
State.
Alternatively, Sec. 35.55(b) requires: (1) the pharmacist to have
completed 700 hours in a structured educational program consisting of
both didactic training in specified subjects and supervised practical
experience in a nuclear pharmacy performing specified tasks; and (2) to
have obtained written certification, signed by a preceptor authorized
nuclear pharmacist, that the individual has satisfactorily completed
the didactic training and supervised practical experience and has
achieved a level of competency sufficient to function independently as
an authorized nuclear pharmacist.
Cost Impacts: The cost impacts associated with this section involve
additional costs to NRC/Agreement States to recognize specialty boards,
to certification boards for preparing materials supporting their
recognition, and to some individuals seeking to be an authorized
nuclear pharmacist for the cost of a preceptor certification.
NRC estimates that approximately 20 pharmacists will seek to become
authorized nuclear pharmacists under Sec. 35.55 or equivalent Agreement
State regulations annually. Of these, 90 percent, or 19 pharmacists,
will seek certification by a certifying board under Sec. 35.55(a). No
additional cost impacts are created for them under the final rule. NRC
estimates that the remainder, or approximately one pharmacist, will
seek to become an authorized nuclear pharmacist under Sec. 35.55(b).
New costs for securing a preceptor statement are created by the final
rule.
Under Sec. 35.55(a), NRC estimates that approval by NRC/Agreement
States of specialty boards for certification will require four hours
per board and that NRC/Agreement States will be required to review two
boards for approval.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 2; NRC/Agreement
States review time: 4 hours/board at $75 per hour; Total Cost Increase:
$1,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards reviewed: 2; Preparation of
submission: 12 hours/board for Technical Staff at $30/hour; 4 hours/
board for Management at $100/hour; Total Cost Increase for Certifying
Boards: $2,000; Total Cost Increase for Sec. 35.55(a): $3,000.
Under Sec. 35.55(b), the costs to licensees associated with
obtaining a preceptor's certification are estimated below.
Assumptions:
Licensees: Number of candidates: 1; Cost of preceptor
certification: \1/2\ hour at $20/hour for candidate plus \1/2\ hour at
$100/hour for preceptor; Total Cost Increase for Sec. 35.55(b):
<$1,000; Total Cost Increase for Sec. 35.55: $3,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.31 Training for experienced Radiation Safety Officer, teletherapy or
medical physicist, authorized user, and nuclear pharmacist
(Sec. 35.57).
Three sections of the current rule, Sec. Sec. 35.901, 35.970, and
35.981, address training requirements for experienced Radiation Safety
Officers, experienced authorized users, and experienced nuclear
pharmacists. (The current Sec. 35.57 addresses authorization for
calibration and reference sources. That topic is addressed in the final
rule in Sec. 35.65.)
The current rule, in Sec. 35.901, provides that an individual
identified as a Radiation Safety Officer on Commission or Agreement
States license before October 1, 1986, need not comply with
Sec. 35.900.
The current rule, in Sec. 35.970, provides that physicians,
dentists, or podiatrists identified as authorized users for the
medical, dental, or podiatric use of byproduct material on Commission
or Agreement States licenses before April 1, 1987, performing only
those methods of use for which they were originally licensed, need not
comply with the training requirements and Subpart J.
The current rule, in Sec. 35.981, requires licensees to apply for
and receive a license amendment identifying an experienced nuclear
pharmacist as an authorized nuclear pharmacist before the individual
can begin work as an authorized nuclear pharmacist. It allows
pharmacists who completed a structured educational program, as
specified in Sec. 35.980(b)(1) before December 2, 1994, to qualify as
an ``experienced nuclear pharmacist'' and need not comply with the
requirements for a preceptor statement (Sec. 35.980(b)(2)) or
recentness of training (Sec. 35.972).
The final rule renumbers and merges Sec. Sec. 35.901, 35.970, and
35.981 as Sec. 35.57 and makes the following changes:
Section 35.57(a) provides that an individual identified as a
Radiation Safety Officer, teletherapy or medical physicist, or a
nuclear pharmacist on a Commission or Agreement State license, or
master material license permit or by a master material license
permittee of broad scope, before a specified date, need not comply with
the training requirements of Sec. Sec. 35.50, 35.51, or 35.55,
respectively.
Section 35.57(b) replaces the April 1, 1987, threshold date
associated with physicians, dentists, or podiatrists identified as
authorized users for the medical, dental, or podiatric use of byproduct
material with a date to be later specified. It also changes the
training and experience citation from Subpart J to Subparts D through
H.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.32 Recentness of training (Sec. 35.59).
The current rule, in Sec. 35.972, specifies that the training and
experience required under 10 CFR Part 35 must have been obtained within
the 7 years preceding the application date or been met by continuing
education and experience. (The current Sec. 35.59 addresses
requirements for possession of sealed sources and brachytherapy
sources. That topic is addressed in the final rule in Sec. 35.67.)
The final rule renumbers Sec. 35.972 as Sec. 35.59 and substitutes
references to the appropriate Subparts B and D through H of the final
rule for the citations to the training and experience requirements in
the current rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
subpart c--general technical requirements
5.33 Possession, use, and calibration of instruments to measure the
activity of unsealed byproduct material (Sec. 35.60).
Section 35.50 of the current rule requires licensees to possess a
dose calibrator and to check each dose calibrator for constancy and to
test each dose calibrator for accuracy, linearity, and geometric
dependence. It specifies when these checks and tests must occur, and
how they are performed.
The final rule combines requirements for calibration of instruments
used to measure the activity of unsealed byproduct materials into one
section, and renumbers Sec. 35.50 as Sec. 35.60. Section 35.60(a)
requires, for direct measurements performed in accordance with
Sec. 35.63, that licensees possess and use instrumentation to measure
the activity of unsealed byproduct material before it is administered
to each patient or human research subject. Section 35.60(b) requires a
licensee to calibrate the instrumentation in accordance with nationally
recognized standards or the manufacturer's instructions. Section
3560(c) requires a record of each instrument calibration to be retained
in accordance with Sec. 35.2060.
Cost Impacts: Cost savings are anticipated as a result of the
requirements for instrument calibration becoming more flexible, more
adaptable to new technology, and more performance-based. In addition,
if a licensee administers only unit dosages from manufacturers or
preparers and uses decay methods to determine the dosages, the licensee
is not required to have a measurement instrument and, thus, is exempt
from the calibration requirements of this section.
Assumptions:
Licensees: Total licensees: 5,793; Reduced annual testing, hours:
3; Technical staff hourly rate: $30; Total Annual Cost Savings from
Sec. 35.60: $521,000.
Health and Safety Impacts: No health and safety impacts are
anticipated from this amendment.
Benefits: Cost savings to licensees who use only unit doses from
manufacturers and preparers and use decay methods to determine the
dosages and therefore are not required to calibrate a measurement
instrument, and cost savings to all licensees from increased
flexibility in requirements for instrument calibration.
5.34 Calibration of survey instruments (Sec. 35.61).
Section 35.51 currently requires licensees to calibrate each survey
instrument before first use, annually, and following repair. The
current rule also requires the licensee to check each survey instrument
for proper operation with a dedicated check source each day of use.
The final rule renumbers Sec. 35.51 as Sec. 35.61 and makes the
following changes:
The final rule, in Sec. 35.61(a), requires licensees to calibrate
the survey instruments used to show compliance with 10 CFR Part 35 and
with 10 CFR Part 20 before first use, annually, and following repairs
that affect the calibration.
The final rule, in Sec. 35.61(a), specifies that the licensee must
calibrate all scales with readings up to 10 mSv (1000 mrem) per hour
with a radiation source, calibrate two separated readings on each scale
or decade that will be used to show compliance, and conspicuously note
on the instrument the date of calibration.
Section 35.61(b) provides that the licensee may not use survey
instruments if the difference between the indicated exposure rate and
the calculated exposure rate is more than 20 percent.
The final rule eliminates the requirement that the survey
instrument be checked for proper operation with a dedicated check
source each day of use.
Section 35.61(c) requires the licensee to retain a record of each
survey instrument calibration in accordance with Sec. 35.2061.
Cost Impacts: Cost savings are anticipated for licensees from the
elimination of daily checks with a dedicated check source.
Assumptions:
Licensees: Total licensees: 5,793; Annual days survey instruments
checked: 260; Time to test survey instruments daily, hours: 0.003;
Technical staff hourly rate: $30; Total Annual Cost Savings from
Sec. 35.61: $136,000.
Health and Safety Impacts: None anticipated. Under 10 CFR
20.1501(b), licensees continue to be required to ensure that
instruments and equipment are calibrated periodically.
Benefits: Cost savings to licensees.
5.35 Determination of dosages of unsealed byproduct material for
medical use (Sec. 35.63).
Section 35.53 currently requires that licensees measure the
activity of dosages of unsealed byproduct material for medical use. It
requires activity of dosages of a photon-emitting radionuclide to be
measured, and activity of dosages of alpha- and beta-emitting
radionuclides to be measured by direct measurement or a combination of
measurements and calculations, except for unit dosages obtained from a
manufacturer or preparer licensed pursuant to 10 CFR 32.72 or
equivalent Agreement State requirements. Results are required to be
kept for 3 years and Sec. 35.53 includes requirements for the contents
of these records.
The final rule renumbers Sec. 35.53 as Sec. 35.63. Section 35.63(a)
requires licensees to determine and record the activity of each dosage
before medical use.
Section 35.63(b) provides that for a unit dosage this determination
must be made by direct measurement of radioactivity or a decay
correction, based on the activity or activity concentration determined
by a manufacturer or preparer licensed under Sec. 32.72 or equivalent
Agreement State requirements or an NRC or Agreement State licensee in
accordance with a Radioactive Drug Research Committee approved protocol
or an Investigational New Drug (IND) protocol accepted by the FDA for
use in research.
Section 35.63(c) requires that for other than unit dosages, this
determination must be made by direct measurement of radioactivity, a
combination of measurement of radioactivity and mathematical
calculations, or by a combination of volumetric measurements and
mathematical calculations based on the measurement made by a
manufacturer or preparer licensed under Sec. 32.72 or equivalent
Agreement State requirements.
Section 35.63(e) provides that the licensee must retain a record of
the dosage determination in accordance with new Sec. 35.2063.
Cost Impacts: The time necessary to perform a decay correction to
determine the dosage of a unit dosage that is not measured directly is
not significant different from the time necessary to remeasure a unit
dosage in a dose calibrator. Cost savings result only for licensees who
use only unit dosages, because they will not have to possess, use, and
maintain a dose calibrator. However, most licensees are expected to
retain possession of existing dose calibrators for use if needed.
Health and Safety Impacts: No health and safety impacts are
anticipated from the changes to Sec. 35.63 because unit dosages will be
measured by the manufacturer or commercial nuclear pharmacy.
Benefits: NRC anticipates that licensees using only unit dosages
will gain added flexibility under Sec. 35.63 to rely on decay
correction rather than direct measurement to determine the activity of
dosages. If those licensees who use only unit dosages have no other
need for a dose calibrator, they will not be required to obtain or
replace dose calibrators for measurement of dosages.
Cost savings to licensees who use only unit dosages and do not
possess a dose calibrator.
5.36 Authorization for calibration, transmission, and reference sources
(Sec. 35.65).
Section 35.57 currently allows each authorized licensee to receive,
possess, and use byproduct material for check, calibration, and
reference use under specific requirements.
The final rule renumbers Sec. 35.57 as Sec. 35.65 and allows any
person authorized by Sec. 35.11 for medical use of byproduct material
to receive, possess, and use any of the byproduct material specified in
Sec. 35.65 for check, calibration, transmission, and reference use as
specified in Sec. Sec. 35.65(a)-(d).
Section 35.65(a) specifies sealed sources manufactured and
distributed by a person licensed under Sec. Sec. 32.74 or equivalent
Agreement State regulations and that do not exceed 1.11 Gbq (30 mCi)
each. The final rule increases the maximum sealed source activity from
0.56 MBq (15 mCi) to 1.11 MBq (30 mCi).
Section 35.65(b) specifies sealed sources redistributed by a person
licensed under Sec. Sec. 32.74 or equivalent Agreement State
regulations and that do not exceed 1.11 Gbq (30 mCi) each. The final
rule specifies these redistributed sealed sources must be in the
original packaging and shielding and be accompanied by the
manufacturer's approved instructions. The final rule also increases the
maximum sealed source activity from 0.56 MBq (15 mCi) to 1.11 MBq (30
mCi).
Section 35.65(c) specifies any byproduct material with a half-life
not longer than 120 days in individual amounts not to exceed 0.56 Gbq
(15 mCi).
Section 35.65(d) specifies any byproduct material with a half-life
longer than 120 days in individual amounts not to exceed 7.4 MBq (200
Ci) or 1,000 times the quantities in Appendix B of 10 CFR Part 30.
Section 35.65(e) specifies technicium-99m may be received,
possessed, and used in amounts ``as needed,'' rather than in amounts
not to exceed 50 millicuries, as provided in the current rule.
Cost Impacts: Cost savings are anticipated with the final changes
to Sec. 35.65, formerly Sec. 35.57. Licensees will not need to obtain
license amendments to obtain higher activity check sources. NRC
estimates that up to 151 amendments per year will be avoided.
Assumptions:
Licensees: Total NRC/Agreement States amendments avoided
(estimated): 151; Technical staff preparation time, hours: 1; Technical
staff hourly rate: $30; Total Annual Cost Savings for licensees:
$5,000.
NRC/Agreement States: NRC/Agreement States amendments avoided: 151;
NRC/Agreement States amendment review: 1 hour/amendment at $75; Total
Annual Cost Savings for NRC and Agreement States: $11,000; Total Annual
Cost Savings from Sec. 35.65: $16,000.
Health and Safety Impacts: None anticipated.
Benefits: Improved flexibility for licensees.
5.37 Requirements for possession of sealed sources and brachytherapy
sources (Sec. 35.67).
Section 35.59 currently requires each licensee in possession of
sealed or brachytherapy sources to follow the radiation safety and
handling instructions supplied by the manufacturer as well as leak test
requirements specified in Sec. 35.59.
The final rule renumbers Sec. 35.59 as Sec. 35.67.
Section 35.67(a) requires licensees in possession of any sealed or
brachytherapy source to follow the radiation safety and handling
instructions supplied by manufacturers.
Section 35.67(b) requires a licensee in possession of a sealed
source to test the source for leakage before its first use, unless the
licensee has a certificate from the supplier indicating that the source
was tested within six months before transfer to the licensee; and test
the source for leakage at intervals not to exceed six months or at
other intervals approved by the Commission or an Agreement State in the
Sealed Source and Device Registry.
Section 35.67(c) requires that to satisfy leak test requirements,
licensees must measure the sample so that the leak test can detect the
presence of 185 Bq (0.005 Ci) of radioactive material in the sample.
Section 35.67(d) requires licensees to retain leak test records in
accordance with Sec. 35.2067.
Section 35.67(e) specifies that if the leak test reveals the
presence of 185 Bq (0.005 Ci) or more of removable contamination the
licensee shall immediately withdraw the source from use and store,
dispose, or cause it to be repaired in accordance with 10 CFR Parts 20
and 30. The licensee also is required to file a report within five days
of the leak test in accordance with Sec. 35.3067.
Section 35.67(f) provides that a licensee need not perform a leak
test on certain specified sources.
Section 35.67(g) requires licensees in possession of sealed or
brachytherapy sources, except for gamma stereotactic radiosurgery
sources, to conduct a semi-annual physical inventory of all such
sources in their possession. This section requires the licensee to
retain each inventory record in accordance with Sec. 35.2067.
The final rule also eliminates paragraphs Sec. Sec. 35.59(h) and
(i) in the current rule, which require quarterly measurement of ambient
dose rates in areas where sealed sources or brachytherapy sources are
stored and retention of records of surveys. Surveys continue to be
required to be performed to demonstrate compliance with 10 CFR Part 20.
Cost Impacts: Cost savings, from reduction in frequency of required
source inventory from quarterly to semiannually.
Assumptions:
Licensees: Total affected licensees: 1,876 \12\; Reduction in
frequency of required source inventory, hours: 1; Technical staff
hourly rate: $30; Total Annual Cost Savings from Sec. 35.67: $56,000.
---------------------------------------------------------------------------
\12\ Sum of licensees in Program Codes 2110, 2210, 2230, 2231, and
2300; plus 30 percent of licensees in Program Codes 2120 and 2200,
estimated as possessing multiple sources. Program Codes 2121 and 2201
were not included because sealed sources in their possession are likely
used and recorded daily, such as for dose calibrator calibration.
---------------------------------------------------------------------------
Health and Safety Impacts: None anticipated. The source inventory
requirements of Sec. 35.67(g) of the final rule, the requirements of 10
CFR 20.1501(a)(2)(iii), as well as the occupational dose and ALARA
requirements of 10 CFR Part 20, adequately address ambient dose rate
measurements in areas where sealed sources are stored.
Benefits: Cost savings to licensees and increased flexibility for
licensees.
5.38 Labeling of vials and syringes (Sec. 35.69).
Section 35.60 currently requires that licensees keep syringes
containing byproduct material conspicuously labeled and in a radiation
shield that is also conspicuously labeled. Use of a syringe radiation
shield is required when preparing and administering the
radiopharmaceutical.
Section 35.61 currently requires that licensees preparing or
handling vials containing byproduct material keep them conspicuously
labeled and in a vial radiation shield that is also conspicuously
labeled.
The final rule deletes Sec. Sec. 35.60 and 35.61 and replaces them
with a new Sec. 35.69. The final rule requires that each syringe and
vial that contains unsealed byproduct material must be labeled to
identify the radioactive drug. Each syringe shield and vial shield also
must be labeled unless the label on the syringe or vial is visible when
shielded.
Cost Impacts: None anticipated. Licensees are expected to rely on
labeling of vials and syringes by suppliers or in-house nuclear
pharmacies and to properly label shields for vials and syringes.
Labeling under the final rule is expected to require approximately the
same time as under the current rule.
Health and Safety Impacts: None anticipated.
Benefits: Increased flexibility for licensees.
5.39 Surveys of ambient radiation exposure rate (Sec. 35.70).
Section 35.70 currently provides specific requirements for
licensees to conduct daily and weekly surveys.
Section 35.70(a) of the final rule requires, in addition to the
surveys required by Part 20, that a licensee shall survey with a
radiation detection survey instrument at the end of each day of use all
areas where unsealed byproduct materials requiring a written directive
were prepared for use or administered.
Section 35.70(b) provides that a licensee does not need to perform
the surveys required by Sec. 35.70(a) in an area(s) where patients or
human research subjects are confined when they cannot be released under
Sec. 35.75.
Section 35.70(c) requires licensees to retain a record of each
survey in accordance with Sec. 35.2070.
The final rule also eliminates in their entirety paragraphs
Sec. Sec. 35.70(b)-(g) in the current rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: No health or safety impact is
anticipated from this amendment. NRC assumes most 10 CFR Part 35
licensees will continue to conduct adequate surveys as part of their
radiation protection program.
Benefits: Increased flexibility for licensees.
5.40 Release of individuals containing unsealed byproduct material or
implants containing byproduct materials (Sec. 35.75).
Section 35.75 currently requires the following:
(a) The licensees may authorize the release from its control of any
individual who has been administered radiopharmaceuticals or permanent
implants containing radioactive material if the total effective dose
equivalent to any other individual from exposure to the released
individual is not likely to exceed five millisieverts (0.5 rem).
(b) The licensee shall provide the released individual with
instructions, including written instructions, on actions recommended to
maintain doses to other individuals as low as is reasonably achievable
if the total effective dose equivalent to any other individual is
likely to exceed one millisievert (0.1 rem). If the dose to a breast-
feeding infant or child could exceed one millisievert (0.1 rem)
assuming there were not interruption of breast-feeding, the
instructions shall also include:
(1) Guidance on the interruption or discontinuation of breast-
feeding and
(2) Information on the consequences of failure to follow the
guidance.
(c) The licensee shall maintain a record of the basis for
authorizing the release of an individual, for 3 years after the date of
release, if the total effective dose equivalent is calculated by:
(1) Using the retained activity rather than the activity
administered,
(2) Using an occupancy factor less than 0.25 at one meter,
(3) Using the biological or effective half-life, or
(4) Considering the shielding by tissue.
(d) The licensee shall maintain a record, for 3 years after the
date of release, that instructions were provided to a breast-feeding
woman if the radiation dose to the infant or child from continued
breast-feeding could result in a total effective dose equivalent
exceeding five millisieverts (0.5 rem).
The final rule essentially retains Sec. 35.75 and provides that
records of the release of individuals containing unsealed byproduct
material or implants containing byproduct material are to be maintained
in accordance with Sec. Sec. 35.2075(a) and (b). Section 35.75 also
makes the following changes in the final rule: (1) eliminates
``permanent'' from the Sec. 35.75(a); (2) adds ``parent or guardian''
to Sec. 35.75(b); (3) adds ``potential'' and ``if any'' to
Sec. 35.75(b)(2); (4) revises the record requirements in Sec. 35.75(c);
and (5) adds references to the recordkeeping requirements in
Sec. Sec. 35.2075(a) and (b) to Sec. Sec. 35.75(c) and (d),
respectively.
Cost Impacts: No incremental costs or cost savings are anticipated
with Sec. 35.75 for licensees, Agreement States, or NRC.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.41 Provision of mobile medical service (Sec. 35.80).
Section 35.80 currently provides technical requirements for mobile
medical service. Section 35.29 currently specifies the requirements for
licensing mobile nuclear medicine services.
The final rule is revised as follows:
Sections 35.80(a), (b), and (c) of the current rule are eliminated.
Section 35.80(a) of the final rule includes a requirement
previously included in Sec. 35.29(b) of the current rule that licensees
providing mobile medical services must obtain a letter from each
client's management permitting and agreeing to the services, including
a discussion of each entity's responsibilities. The final rule
eliminates the requirement from Part 35 that a licensee transport to
each address of use only syringes or vials containing prepared
radiopharmaceuticals or radiopharmaceuticals that are intended for
reconstitution of radiopharmaceutical kits; the requirement that the
licensee bring into each address of use all byproduct material to be
used and, before leaving, remove all unused byproduct material and all
associated waste; the requirement that the licensee secure or keep
under constant surveillance and immediate control all byproduct
material when in transit or at an address of use; and the requirement
that the licensee carry a radiation detection survey meter in each
vehicle used to transport byproduct material. The final rule continues
to require licensees to check instruments used to measure the activity
of unsealed byproduct materials, specifying that such checks occur
before medical use at each client's address or on each day of use,
whichever is more frequent; requires survey instruments to be checked
for proper operation with a dedicated check source before use at each
client's address; and before leaving a client's address of use, to
survey all areas of use, to ensure compliance with the requirements in
10 CFR Part 20.
Section 35.80(b) prohibits a mobile medical service from having
byproduct material delivered from the manufacturer or the distributor
to the client's address of use, unless the client has a license
allowing possession of the byproduct material. This section requires
that byproduct material delivered to the client's address of use shall
be received and handled in conformance with the client's license.
Section 35.80(c) requires the letter required in paragraph
Sec. 35.80(a)(1) to be retained and the record of each survey required
in paragraph (a)(4) to be retained in accordance with Sec. 35.2080.
Cost Impacts: Section 35.29 has been eliminated and replaced with
requirements in final Sec. Sec. 35.18(b) and 35.80. Under Sec. 35.80,
licensees may be required to incur costs to obtain a dedicated check
source, although in many cases such sources will be supplied with the
survey instruments. Licensees also may already possess check sources,
because the current rule requires instruments to be checked for proper
operation. Therefore, minimal cost impacts (i.e., <$1,000) are
expected.
Health and Safety Impacts: Elimination of the requirements
currently in Sec. Sec. 35.80(1)(a) through (c) is not expected to
result in impacts to health or safety.
Benefits: Conforming change for restructuring of 10 CFR Part 35.
5.42 Storage of volatiles and gases (Sec. 35.90).
Section 35.90 currently requires licensees to store: (1) volatile
radiopharmaceuticals and radioactive gases in the shipper's radiation
shield and container; and (2) multi-dose containers in a fume hood
after drawing the first dosage from it.
The final rule eliminates Sec. 35.90.
Cost Impacts: None anticipated.
Health and Safety: None anticipated. Section 10 CFR 20.1701
currently requires licensees to use, to the extent practical, process
or other engineering controls, such as containment or ventilation, to
control the concentration of radioactive material in air, and 10 CFR
20.1702 requires use of other controls, if necessary, to control
concentrations to values below those that define an airborne
radioactivity area. Elimination of Sec. 35.90 provides licensees with
flexibility to determine the most effective method of storage. NRC
anticipates that in general licensees continue to store volatile
radiopharmaceuticals and radioactive gases in the shipper's radiation
shield and container and to store multi-dose containers in a fume hood.
Benefits: Increased flexibility for licensees.
5.43 Decay-in-storage (Sec. 35.92).
Section 35.92 currently allows licensees to hold byproduct material
with a physical half-life of less than 65 days and dispose of it in
ordinary trash, provided it follows specified handling procedures.
The final rule, in Sec. 35.92(a), increases the maximum allowable
half-life for byproduct material that may be held for decay in storage
from 65 days to 120 days and eliminates a requirement that byproduct
material must be held for decay in storage a minimum of ten half-lives.
Section 35.92 of the final rule also eliminates the requirement to
separate and monitor each generator column individually with all
radiation shielding removed to ensure that it has decayed to background
radiation level before disposal. The final rule amends the requirement
to remove or obliterate all radiation labels to specify that the
licensee must remove or obliterate all radiation labels, except for
radiation labels on materials that are within containers and that will
be managed as biomedical waste, after they have been released from the
licensee.
Section 35.92(b) of the final rule requires licensees to retain a
record of each disposal permitted under paragraph Sec. 35.92(a) in
accordance with Sec. 35.2092.
Cost Impacts: Costs are expected to be avoided by the amendment to
Sec. 35.92(a) as a result of a reduced number of requests for license
amendments to allow an exemption for 120 day half-life for holding
material for a minimum of 10 half-lives. Numerous licensees have
already obtained such amendments, although the precise number is not
available. Therefore, relatively few are expected to be avoided
annually in the future.
Assumptions:
Licensees: Total annual amendments avoided: 17; Technical staff
preparation time, hours: 1; Technical staff hourly rate: $30; Total
Annual Cost Savings for licensees: $1,000.
NRC/Agreement States: NRC/Agreement States amendment review time,
hours: 0.5; NRC/Agreement States staff hourly rate: $75; Total Annual
Cost Savings for NRC and Agreement States:$1,000; Total Annual Cost
Savings from Sec. 35.92: $2,000.
Health and Safety Impacts: None anticipated because licensees are
expected to continue to monitor waste to ensure it has decayed to
background radiation levels before disposal.
Benefits: Increased flexibility for licensees and reduced number of
license amendments.
subpart d--unsealed byproduct material--written directive not required
5.44 Use of unsealed byproduct material for uptake, dilution, and
excretion studies for which a written directive is not required
(Sec. 35.100).
The current rule, in Sec. 35.100, permits a licensee to use for
uptake, dilution, or excretion studies any unsealed byproduct material
that is obtained from a manufacturer or preparer licensed under 10 CFR
32.72 or equivalent Agreement States requirements, or prepared by an
authorized nuclear pharmacist, a physician who is an authorized user
and who meets the requirements specified in Sec. 35.920, or an
individual under the supervision of either as specified in Sec. 35.25.
The final rule amends Sec. 35.100 by limiting the use of unsealed
byproduct material for uptake, dilution, and excretion studies to
medical uses that do not require a written directive pursuant to
Sec. Sec. 35.40(b)(1) or (2). It revises the references in
Sec. 35.100(b) to conform to the final rule. It allows the use of
unsealed byproduct material that is obtained from a manufacturer or
preparer licensed under Sec. 32.72 or equivalent Agreement State
requirements or prepared by an authorized nuclear pharmacist, a
physician who is an authorized user and who meets the requirements
under Sec. Sec. 35.290 or 35.390 or an individual under the supervision
of either. The final rule adds a new section, Sec. 35.100(c),
specifying that material may be used that is obtained from and prepared
by an NRC or Agreement State licensee in research in accordance with a
Radioactive Drug Research Committee-approved (RDRC-approved) protocol
or an Investigational New Drug (IND) protocol accepted by the FDA. It
also adds a new section, Sec. 35.100(d), specifying that material may
be used that is prepared by the licensee for use in research in
accordance with a RDRC-approved application or an IND protocol accepted
by FDA.
Cost Impacts: None anticipated.
Health and Safety Impacts: None Anticipated.
Benefits: The final rule allows: (1) a medical use licensee to
receive radioactive drugs, for use in RDRC-approved or IND research
protocols, prepared and distributed by NRC or Agreement State licensees
who are not Sec. 32.72 licensees; and (2) any individual to prepare a
radioactive drug in accordance with either an RDRC-approved protocol or
an IND protocol.
5.45 Possession of survey instrument (Sec. 35.120).
The current rule, in Sec. 35.120, requires each licensee to have in
its possession a radiation detection survey instrument capable of
detecting dose rates over the range of 0.1 millirem per hour to 100
millirem per hour.
The final rule eliminates Sec. 35.120.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated because licensees must
continue to meet the requirements in 10 CFR 20.1501 and 20.1502 and 10
CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.46 Training for uptake, dilution, and excretion studies
(Sec. 35.190).
The current rule, in Sec. 35.910, specifies the training
requirements for an authorized user of a radiopharmaceutical for
uptake, dilution, and excretion studies.
Section 35.910(a) lists five specialist boards through which an
individual may become certified to perform these procedures.
Alternatively, Sec. 35.910(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
five listed speciality boards. It currently requires 40 hours of
classroom and laboratory training in specified subjects. In addition,
it requires 20 hours of supervised clinical experience.
Alternatively, Sec. 35.910(c) specifies that the individual may
complete a six month training program in nuclear medicine approved by
the Accreditation Council for Graduate Medical Education that includes
the classroom, laboratory, and clinical requirements specified in
paragraph (b).
The final rule, in Sec. 35.190, provides the following:
The list of five approved speciality boards is eliminated. Section
35.190(a) provides instead that the licensee shall require an
authorized user of unsealed byproduct material for the uses authorized
under Sec. 35.100 to be a physician who is certified by a medical
specialty board whose certification process includes all of the
requirements in Sec. 35.190(c) and whose certification has been
recognized by the Commission or an Agreement State.
Alternatively, Sec. 35.190(b) acknowledges physicians who are
authorized users under Sec. Sec. 35.290 or 35.390 or equivalent
Agreement State requirements as meeting the requirements of
Sec. 35.190.
Alternatively, under Sec. 35.190(c), the physician must have
completed 60 hours of training and experience in basic radionuclide
handling techniques applicable to the medical use of unsealed byproduct
material for uptake, dilution, and excretion studies, including
classroom and laboratory training in specified areas; must have work
experience under the supervision of an authorized user who meets the
requirements in Sec. Sec. 35.190, 35.290, or 35.390 or equivalent
Agreement State requirements in specified areas; and must have obtained
written certification, signed by a preceptor authorized user who meets
the requirements in Sec. Sec. 35.190, 35.290, or 35.390 or equivalent
Agreement State requirements, that the individual has satisfactorily
completed the classroom and laboratory training and work experience
requirements and has achieved a level of competency sufficient to
function independently as an authorized user for the medical uses
authorized under Sec. 35.100.
The final rule eliminates the alternative of completing a six-month
program approved by the Accreditation Council for Graduate Medical
Education (Sec. 35.971).
Cost Impacts: NRC anticipates incremental costs associated with
this section involving additional costs to NRC/Agreement States for
recognizing specialty boards, to certification boards for preparing
materials supporting their recognition, and to the authorized user for
the cost of obtaining preceptor certifications.
NRC estimates that approximately 110 physicians seek to become
authorized users under Sec. 35.190 or equivalent Agreement State
regulations annually. Of these, 90 percent, or 99 physicians, seek
certification by a certifying board under Sec. 35.190(a). No additional
cost impacts are created for them under the final rule. NRC estimates
that the remainder, or approximately 11 physicians, seek to become
authorized users under Sec. 35.190(c). New costs for securing a
preceptor statement are created by the final rule.
The costs to NRC/Agreement States for recognizing specialty boards
for purposes of Sec. 35.190(a) are estimated below.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 5; NRC/Agreement
States review time: 4 hours/board at $75 per hour; Total Cost Increase:
$2,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards seeking recognition 5;
Preparation of submission: 12 hours/board for Technical Staff at $30/
hour; 4 hours/board for Management at $100/hour; Total Cost Increase
for Certifying Boards: $4,000; Total Cost Increase for Sec. 35.190(a):
$6,000.
The costs to licensees associated with securing a preceptor's
certification for purposes of Sec. 35.190(b) are estimated on the basis
of 10 percent of candidates seeking authorization through
Sec. 35.190(b).
Assumptions:
Licensees: Number of candidates: 11; Cost of preceptor
certification: \1/2\ hour at $20 hour for candidate \13\ plus \1/2\
hour at $100/hour for preceptor; Total Cost Increase for
Sec. 35.190(b): $1,000; Total Cost Increase for Sec. 35.190: $7,000.
---------------------------------------------------------------------------
\13\ Candidate's time measured at $20 per hour based on a resident
physician's estimated annual salary of $30,000 to $40,000.
---------------------------------------------------------------------------
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.47 Use of unsealed byproduct material for imaging and localization
studies for which a written directive is not required
(Sec. 35.200).
The current rule, in Sec. 35.200, permits a licensee to use for
imaging and localization studies any unsealed byproduct material that
is obtained from a manufacturer or preparer licensed under 10 CFR 32.72
or equivalent Agreement States requirements, or prepared by an
authorized nuclear pharmacist, a physician who is an authorized user
and who meets the requirements specified in Sec. 35.920, or an
individual under the supervision of either as specified in Sec. 35.25.
The final rule amends Sec. 35.200 by limiting the use of unsealed
byproduct material for imaging and localization studies to medical uses
that do not require a written directive pursuant to Sec. 35.40(b). It
revises the references in Sec. 35.200(b) to conform to the final rule.
Section 35.200(b) allows the use of unsealed byproduct material that is
obtained from a manufacturer or preparer licensed under Sec. 32.72 or
equivalent Agreement State requirements or prepared by an authorized
nuclear pharmacist, a physician who is an authorized user and who meets
the requirements under Sec. Sec. 35.290 or 35.390 or an individual
under the supervision of either as specified in Sec. 35.27. The final
rule adds a new section, Sec. 35.200(c), specifying that material may
be used that is obtained from and prepared by an NRC or Agreement State
licensee in research in accordance with a Radioactive Drug Research
Committee-approved (RDRC-approved) protocol or an Investigational New
Drug (IND) protocol accepted by the FDA. The final rule also adds a new
section, Sec. 35.200(d), specifying that material may be used that is
prepared by the licensee for use in research in accordance with a RDRC-
approved application or an IND protocol accepted by FDA.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: The final rule allows: (1) a medical use licensee to
receive radioactive drugs, for use in RDRC-approved or IND research
protocols, prepared and distributed by NRC or Agreement State licensees
who are not Sec. 32.72 licensees; and (2) any individual to prepare a
radioactive drug in accordance with either an RDRC-approved protocol or
an IND protocol.
5.48 Permissible molybdenum-99 concentration (Sec. 35.204).
Section 35.204(a) of the current rule prohibits licensees from
administering to humans a radiopharmaceutical containing more than 0.15
microcurie of molybdenum-99 per millicurie of technetium-99m. Section
35.204(b) requires licensees using molybdenum-99/technetium-99m
generators for preparing a technetium-99m radiopharmaceutical to
measure the molybdenum-99 concentration of each eluate or extract.
The final rule, in Sec. 35.204(a), changes the expression of the
permissible concentration to provide that a licensee may not administer
more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of
technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of
technetium-99m). Section 35.204(b) requires that instead of each
eluate, a licensee that uses molybdenum-99/technetium-99m generators
must measure the molybdenum-99 concentration of the first eluate after
receipt of a generator to demonstrate compliance with Sec. 35.204(a).
Licensees are required to retain records of each measurement in
accordance with the requirements specified in Sec. 35.2204.
Cost Impacts: Cost savings are anticipated from elimination of the
requirement that licensees must measure the molybdenum-99 concentration
of each eluate or extract.
NRC assumes that 591NRC licensees and 1,478 Agreement States
licensees use molybdenum-99/technetium-99m generators. Under the final
rule, sale or transfer of a generator will require the new owner or
user to measure the concentration of the first eluate. Assuming that
generators are replaced weekly, this amendment is expected to reduce
the frequency of measurements from approximately one per day to about
one per week.
Assumptions:
Licensees: Number of licensees: 2,069; Number of avoided eluate
tests per licensee: 200; Time required to measure concentration of
eluate, hours: 0.08; Technical staff hourly rate: $30; Total Annual
Cost Savings from amendment to Sec. 35.204: $993,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings to licensees.
5.49 Control of aerosols and gases (Sec. 35.205).
The current rule, in Sec. 35.205(a), requires licensees to
administer radioactive aerosols or gases in a room with a system that
will keep airborne concentrations below the limits prescribed by 10 CFR
20.1201 and 20.1301. Section 35.205(c) requires that before receiving,
using, or storing a gas, a licensee must calculate the amount of time
needed after a spill to reduce the concentration to the limits
specified in 10 CFR 20.1201, and Sec. 35.205(d) requires the licensee
to make a record of the calculations required by Sec. 35.205(c) and
retain that record for the duration of the use of the area.
The final rule eliminates Sec. 35.205.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated. Licensees will
continue to be required to meet the requirements for occupational dose
limits for adults and dose limits for individual members of the public,
as specified in 10 CFR 20.1201 and 20.1301, respectively.
Benefits: Regulatory flexibility for licensees.
5.50 Possession of survey instruments (Current Sec. 35.220).
The current rule, in Sec. 35.220, requires each licensee to have in
its possession a radiation detection survey instrument capable of
detecting dose rates over the range of 0.1 millirem per hour to 100
millirem per hour.
The final rule eliminates Sec. 35.220.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated because licensees must
continue to meet the requirements in 10 CFR 20.1501 and 20.1502 and 10
CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.51 Training for imaging and localization studies (Sec. 35.290).
The current rule, in Sec. 35.920, specifies the training
requirements for an authorized user of radiopharmaceuticals and
generators for imaging and localization studies.
Section 35.920(a) lists five specialist boards through which an
individual may become certified to perform these procedures.
Alternatively, Sec. 35.920(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
five listed speciality boards. The regulations currently require 200
hours of classroom and laboratory work training (Sec. 35.920(b)(1));
500 hours of supervised work experience (Sec. 35.920(b)(2)); and 500
hours of supervised clinical experience (Sec. 35.920(b)(3)).
Alternatively, Sec. 35.920(c) specifies that the individual may
complete a six month training program in nuclear medicine approved by
the Accreditation Council for Graduate Medical Education that includes
the classroom, laboratory, and clinical requirements specified in
paragraph (b).
The final rule, in Sec. 35.290, provides the following:
The list of five approved speciality boards is eliminated. Section
35.290 provides that except as provided in Sec. 35.57, the licensee
shall require an authorized user of unsealed byproduct material for the
uses authorized under Sec. 35.200 to be a physician certified by a
medical specialty board whose certification process includes all of the
requirements in Sec. 35.290(c) and whose certification has been
recognized by the Commission or an Agreement State.
Alternatively, Sec. 35.290(b) acknowledges physicians who are
authorized users under Sec. 35.390 or equivalent Agreement State
requirements as meeting the requirements of Sec. 35.290.
Alternatively, under Sec. 35.290(c), the physician must have
completed 700 hours of training and experience in basic radionuclide
handling techniques applicable to the medical use of unsealed byproduct
material for imaging and localization studies. The training and
experience must include classroom and laboratory training in specified
areas and work experience, under the supervision of an authorized user
who meets the requirements in Sec. 35.290 or Sec. 35.390 or equivalent
Agreement State requirements, involving specified activities. The
physician must have obtained written certification, signed by a
preceptor authorized user who meets the requirements in
Sec. Sec. 35.290 or 35.390 or equivalent Agreement State requirements,
that the individual has satisfactorily completed the classroom and
laboratory training and work experience required under Sec. 35.290(c)
and has achieved a level of competency sufficient to function
independently as an authorized user for the medical uses authorized
under Sec. Sec. 35.100 and 35.200.
The final rule eliminates the alternative of completing a six-month
training program approved by the Accreditation Council for Graduate
Medical Education (Sec. 35.971).
Cost Impacts: Cost savings are associated with the final rule due
to the reduction in required training hours. NRC assumes that the
reduction in required hours will not be reflected in the educational
process of the certifying boards.
NRC estimates that approximately 110 physicians will seek to become
authorized users under Sec. 35.290 or equivalent Agreement State
regulations annually. Of these, 90 percent, or 99, will seek
certification by a certifying board under Sec. 35.290(a). No additional
cost impacts be created for them under the final rule. NRC estimates
that the remainder, or approximately 11 physicians, will seek to become
authorized users under Sec. 35.290(c). New costs for securing a
preceptor statement are created by the final rule. However, NRC assumes
that individuals will seek certification under both Sec. Sec. 35.190
and 35.290, and that, therefore, no additional costs for preceptor
certification will be incurred because these costs are reflected under
Sec. 35.190.
Additional costs to NRC/Agreement States are associated with the
recognition of specialty boards and preparing the specialty board
submission. Because both Sec. Sec. 35.910(a) and 35.920(a) contain
identical lists of certifying organizations, NRC assumes one review of
each organization to satisfy the requirements of Sec. Sec. 35.190(a)
and 35.290(a). Therefore, the costs to NRC/Agreement States for
recognizing specialty boards for purposes of Sec. 35.290(a) are
estimated under Sec. 35.190(a).
The cost savings that will be realized under this section due to
the reduction in training hours required in Sec. 35.290(c) are
estimated below:
Assumptions:
Licensees: Number of candidates seeking certification through
Sec. 35.290(c): 11; Training hours required under current rule: 1,200
at $20/hour; Training hours required under rule: 700 at $20/hour; Total
Annual Cost Savings from Sec. 35.290: $238,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.52 Elimination of Sec. 35.971 of the current rule (Physician training
in a three month program).
Section 35.971 of the current rule provides that a physician who
began a three month nuclear medicine training program approved by the
Accreditation Council for Graduate Medical Education before July 1,
1984, and successfully completed the program was not required to comply
with the requirements of Sec. Sec. 35.910 or 35.920.
The final rule deletes Sec. 35.971.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Consistency with the revised training and experience
requirements.
subpart e--unsealed byproduct material--written directive required
5.53 Use of unsealed byproduct material for which a written directive
is required (Sec. 35.300).
The current rule, in Sec. 35.300, provides that a licensee may use
unsealed byproduct material prepared for medical use for therapeutic
administration that is either obtained from a manufacturer or preparer
licensed under Sec. 32.72 or equivalent Agreement State requirements,
or prepared by an authorized nuclear pharmacist, a physician who is an
authorized user and who meets the requirements specified in
Sec. 35.920, or an individual under the supervision of either as
specified in Sec. 35.25.
Section 35.300 of the final rule is revised to indicate that it
applies to any medical use of unsealed byproduct material for which a
written directive is required. The final rule also changes the
reference to the training and experience requirements for authorized
users to Sec. Sec. 35.290 or 35.390 and the reference to the regulatory
requirements for supervision (Sec. 35.27). It adds two additional
subsections indicating that it also applies to use of unsealed
byproduct material obtained from NRC or an Agreement State licensee in
accordance with an Investigational New Drug (IND) application accepted
by FDA or prepared by the licensee for use in accordance with an IND
protocol accepted by FDA for use in research.
Cost Impacts: None anticipated.
Health and Safety: None anticipated.
Benefits: Provides clarification that any medical use of unsealed
byproduct material (e.g., diagnostic or therapeutic) requiring a
written directive are included under this subpart. Also, the final rule
allows specific licensees to obtain unsealed byproduct material
prepared by other NRC or Agreement State licensees for use in medical
research in accordance with an IND protocol accepted by the FDA.
5.54 Safety Instruction (Sec. 35.310).
Section 35.310(a) of the current rule requires safety instruction
for all personnel caring for the patient or human research subject
receiving radiopharmaceutical therapy and hospitalized under
Sec. 35.75. Instruction is required in the following areas: (1) patient
or human research subject control; (2) visitor control; (3)
contamination control; (4) waste control; and (5) notification of the
Radiation Safety Officer in case of patient death or medical emergency.
Section 35.310(b) requires that the licensee retain records of
individuals receiving instruction for 3 years.
The final rule adds a provision specifying that the requirements of
Sec. 35.310 are in addition to the worker instruction requirements of
10 CFR 19.12. Section 35.310(a) provides that radiation safety
instruction must be given initially and at least annually to personnel
caring for patients or human research subjects who cannot be released
in accordance with Sec. 35.75. Section 35.310(a) also specifies that
such training must be commensurate with the duties of the personnel and
what such training must include. Section 35.310(b) of the final rule
requires records of persons receiving instruction to be retained in
accordance with Sec. 35.2310.
Cost Impacts: No cost impacts anticipated. The requirements are
consistent with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Increased radiation safety.
5.55 Safety Precautions (Sec. 35.315).
Section 35.315(a) currently specifies safety precautions that
licensees must take for each patient receiving radiopharmaceutical
therapy and hospitalized for compliance with Sec. 35.75.
Section 35.315(a)(1) requires a private room with a private
sanitary facility.
Section 35.315(a)(2) requires posting a ``Radioactive Materials''
sign on the patient's door and indicating on the door or in the
patient's chart where and how long visitors may stay in the room.
Section 35.315(a)(3) authorizes visits by individuals under age 18
on a case-by-case basis with the approval of the authorized user after
consultation with the Radiation Safety Officer.
Section 35.315(a)(4) requires the licensee to measure dose rates in
contiguous areas promptly after administration of the dosage and retain
for 3 years a record of each survey demonstrating compliance with 10
CFR Part 20.
Section 35.315(a)(5) requires the licensee to monitor items removed
from the patient's room to determine that their radioactivity is not
greater than background radioactivity or handle them as radioactive
waste.
Section 35.315(a)(6) is reserved.
Section 35.315(a)(7) requires the licensee to survey the patient's
room for removable contamination before assigning another patient the
same room.
Section 35.315(a)(8) requires the licensee to measure the thyroid
burden of each individual who helped prepare or administer a dosage of
I-131 and retain a record of each measurement.
Section 35.315(b) requires a licensee to notify the Radiation
Safety Officer if the patient has a medical emergency or dies.
The final rule makes the following changes to Sec. 35.315:
Section 35.315(a) specifies licensee actions for each patient or
human research subject who cannot be released in accordance with
Sec. 35.75.
Section 35.315(a)(1) requires the licensee to quarter the patient
or human research subject in either: (1) a private room with a private
sanitary facility or (2) a room with a private sanitary facility, with
another individual who also has received therapy with unsealed
byproduct material and who also cannot be released pursuant to
Sec. 35.75.
Section 35.315(a)(2) and (a)(3) require the patient's or the human
research subject's room to be posted with a ``Radioactive Materials''
sign and a note on the door or in the patient's or human research
subject's chart stating where and how long visitors may stay in the
room.
Sections 35.315(a)(3) and (a)(4) in the current rule are
eliminated.
Section 35.315(a)(5) in the current rule is renumbered as
Sec. 35.315(a)(4) in the final rule.
Sections 35.315(a)(6), (a)(7) and (a)(8) in the current rule are
eliminated.
Section 35.315(b) clarifies that licensees shall notify the
authorized user and the Radiation Safety Officer, or his or her
designee, as soon as possible if the patient or human research subject
has a medical emergency or dies.
Cost Impacts: Cost savings may exist from Sec. 35.315(a)(1)(ii)
allowing two patients who cannot be released to be quartered in the
same room. Cost savings may be possible if, when medical institutions
elect to quarter two patients together, they are able to slightly
increase occupancy rates.
No cost impacts are anticipated from elimination of
Sec. Sec. 35.315(a)(3), (4), and (6)-(8) of the current rule. Licensees
will continue to be required to comply with 10 CFR Part 20.
Health and Safety Impacts: None anticipated.
Benefits: Improved flexibility for licensees.
5.56 Possession of survey instruments (Sec. 35.320).
The current rule, in Sec. 35.320, requires each licensee to have in
its possession portable radiation detection survey instruments.
The final rule eliminates Sec. 35.320.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated because licensees must
continue to meet the requirements in 10 CFR 20.1501 and 20.1502 and 10
CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.57 Training for use of unsealed byproduct material for which a
written directive is required (Sec. 35.390).
The current rule, in Sec. 35.930, specifies the training
requirements for an authorized user of radiopharmaceuticals for
therapeutic administration of unsealed byproduct material.
Section 35.930(a) lists four specialist boards through which an
individual may become certified.
Alternatively, Sec. 35.930(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
four listed speciality boards. It currently requires 80 hours of
classroom and laboratory training in specified subjects. In addition,
it requires supervised clinical experience, including use of I-131 for
diagnosis of thyroid function and the treatment of hyperthyroidism or
cardiac dysfunction in 10 individuals and use of I-131 for treatment of
thyroid carcinoma in three individuals.
The final rule renumbers Sec. 35.930 as Sec. 35.390 and makes the
following changes:
The list of four approved speciality boards is eliminated. Section
35.390 provides that except as provided in Sec. 35.57, the licensee
shall require an authorized user of unsealed byproduct material for the
uses authorized under Sec. 35.300 to be a physician who is certified by
a medical specialty board whose certification process includes all of
the requirements in Sec. 35.390(b) and whose certification has been
recognized by the Commission or an Agreement State.
Alternatively, the licensee shall require an authorized user to
have completed the training and experience specified in Sec. 35.390(b)
and to have obtained written certification signed by a preceptor
authorized user meeting certain specified requirements.
Section 35.390(b)(1) requires completion of 700 hours of training
and experience in basic radionuclide handling techniques applicable to
the medical use of unsealed byproduct material requiring a written
directive. It specifies the topics in which classroom and laboratory
training must occur and the areas in which work experience, under the
supervision of an authorized user meeting specified requirements, must
occur. Section 35.390(b)(1)(ii)(G) specifies that experience must
include administering dosages of radioactive drugs to patients or human
research subjects involving a minimum of three cases in each of the
categories for which the individual is requesting authorized user
status, and lists four categories of administration in
Sec. 35.390(b)(1)(ii)(G)(1) through (G)(4).
Section 35.390(b)(2) replaces the current Sec. 35.930(b)(2).
Section 35.390(b)(2) requires that the individual obtain written
certification, signed by a preceptor authorized user who meets the
requirements in Sec. 35.390(a) or specified sections of Sec. 35.390(b),
or equivalent Agreement State requirements, that the individual has
satisfactorily completed the requirements in Sec. 35.390(b) and has
achieved a level of competency sufficient to function independently as
an authorized user for the medical uses authorized under Sec. 35.300.
Cost Impacts: The cost impacts associated with this section involve
additional costs to NRC/Agreement States for recognition of certifying
specialty boards, and to certifying boards for preparing materials
supporting their recognition. Some individuals seeking to be an
authorized user will incur costs for additional training and for
preceptor certification.
NRC estimates that approximately 100 physicians will seek to become
authorized users under Sec. 35.390 or equivalent Agreement State
regulations annually. Of these, 95 percent will seek certification by a
certifying board under Sec. 35.390(a). Training currently accepted by
the Accreditation Council for Graduate Medical Education or the
Committee on Postdoctoral Training of the American Osteopathic
Association includes more than 700 hours of classroom and laboratory
training and practical experience. Therefore, no additional costs will
be incurred by these applicants to satisfy the new 700 hour training
and experience requirement in Sec. 35.390(b). The remaining five
percent, an estimated four physicians, will seek to become authorized
users by satisfying the training and experience requirements in
Sec. 35.390(b). They will incur costs for the additional 620 hours of
training and experience required under the final rule and for obtaining
a preceptor certification.
Costs to NRC/Agreement States for recognizing specialty boards for
purposes of Sec. 35.390(a) are estimated below.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 1; NRC/Agreement
States review time:4 hours/board at $75 per hour; Total Cost Increase:
<$1,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards reviewed: 1; Preparation of
submission: 12 hours/board for Technical Staff at $30/hour; 4 hours/
board for Management at $100/hour; Total Cost Increase for Certifying
Boards: $1,000; Total Cost Increase for Sec. 35.390(a): $1,000.
NRC estimates that approximately four applicants, will seek to
become authorized users under Sec. 35.390(b). The costs to licensees
associated with training and securing a preceptor's certification for
purposes of Sec. 35.390(b) are estimated below.
Costs to applicants for additional training and experience:
Assumptions:
Licensees: Total licensees: 5; Number of additional hours of
training required: 620; Authorized user candidate hourly rate: $20;
Total Cost Increase from additional training requirements for
Sec. 35.390(b): $62,000.
New costs for securing a preceptor statement under Sec. 35.390(b)
are created by the final rule.
Assumptions:
Licensees: Number of candidates: 5; Cost of preceptor certification
(\1/2\ hour of preceptor's time at $100/hour plus \1/2\ hour of
candidate's time at $20/hour): $60; Cost Increase for obtaining
preceptor certification under Sec. 35.390(b): <$1,000; Total Cost
Increase for Sec. 35.390: $63,000.
Health and Safety Impacts: TNone anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.58 Training for the oral administration of sodium iodide I-131
requiring a written directive in quantities less than or equal
to 1.22 Gigabecquerels (33 millicuries) (Sec. 35.392).
The current rule, in Sec. 35.930, specifies the training
requirements for an authorized user of radiopharmaceuticals for
therapeutic administration of unsealed byproduct material and in
Sec. 35.932 specifies the training requirements for an authorized user
of iodine-131 for the treatment of hyperthyroidism.
Section 35.930(a) lists four specialist boards through which an
individual may become certified.
Alternatively, Sec. 35.930(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
four listed speciality boards. It currently requires 80 hours of
classroom and laboratory training in specified subjects. In addition,
it requires supervised clinical experience, including use of I-131 for
diagnosis of thyroid function and the treatment of hyperthyroidism or
cardiac dysfunction in 10 individuals and use of I-131 for treatment of
thyroid carcinoma in three individuals.
Section 35.932 specifies that the licensee shall require the
authorized user of only iodine-131 for the treatment of hyperthyroidism
to be a physician with special experience in thyroid disease who has
had classroom and laboratory training in basic radioisotope handling
techniques applicable to the use of iodine-131 for treating
hyperthyroidism and supervised clinical experience consisting of 80
hours of classroom and laboratory training that includes specified
subjects, and also supervised clinical experience under the supervision
of an authorized user that includes the use of iodine-131 for diagnosis
of thyroid function and the treatment of hyperthyroidism in 10
individuals.
The final rule creates a new Sec. 35.392 providing the following:
Section 35.392(a) provides that, except as provided in Sec. 35.57,
the licensee shall require an authorized user for the oral
administration of sodium iodide I-131 requiring a written directive in
quantities less than or equal to 1.22 Gigabecquerels (33 millicuries)
to be a physician who is certified by a medical specialty board whose
certification process includes all of the requirements in
Sec. 35.392(c) and whose certification has been recognized by the
Commission or an Agreement State.
Alternatively, Sec. 35.392(b) provides that the licensee shall
require an authorized user to be an authorized user under
Sec. Sec. 35.390(a), 35.390(b), for uses listed in
Sec. Sec. 35.390(b)(1)(ii)(G)(1) or (2), or 35.394 or equivalent
Agreement State requirements.
Alternatively, Sec. 35.392(c) provides that the licensee shall
require an authorized user to have: (1) successfully completed 80 hours
of classroom and laboratory training in specified subjects; (2) work
experience under the supervision of an authorized user who meets
specified requirements involving specified activities, including
administering dosages to patients or human research subjects that
includes at least 3 cases involving the oral administration of less
than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide
I-131; and (3) obtained written certification, signed by a preceptor
authorized user who meets specified requirements, that the individual
has successfully completed the classroom and laboratory and work
experience requirements and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses of unsealed byproduct material using sodium iodide I-131.
Cost Impacts: NRC anticipates incremental costs associated with
this section involving additional costs to NRC/Agreement States for
certifying medical specialty boards. NRC anticipates costs to the
physicians seeking authorized user status from obtaining the
preceptor's certification.
NRC estimates that approximately 100 physicians will seek to become
authorized users under Sec. 35.392 or equivalent Agreement State
regulations annually. Of these, 90 percent will seek certification by a
certifying board under Sec. 35.392(a). No additional cost impacts be
created for them under the final rule. NRC estimates that the
remainder, approximately 10 physicians, will seek to become authorized
users under Sec. 35.392(c). New costs for securing a preceptor
statement are created by the final rule.
Costs to NRC/Agreement States for recognizing specialty boards for
purposes of Sec. 35.392(a) are estimated below.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 2; NRC/Agreement
States review time:4 hour/board at $75 per hour; Total Cost Increase:
$1,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards reviewed: 2; Preparation of
submission: 12 hours/board for Technical Staff at $30/hour; 4 hours/
board for Management at $100/hour; Total Cost Increase for Certifying
Boards: $2,000; Total Cost Increase for Sec. 35.392(a): $3,000.
New costs for securing a preceptor statement under Sec. 35.392(c)
are created by the final rule.
Assumptions:
Licensees: Number of candidates: 10; Cost of preceptor
certification (\1/2\ hour of preceptor's time at $100/hour plus \1/2\
hour of candidate's time at $20/hour): $60; Cost Increase for obtaining
preceptor certification under Sec. 35.392(c): $1,000; Total Cost
Increase for Sec. 35.392: $4,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.59 Training for the oral administration of sodium iodide I-131
requiring a written directive in quantities greater than 1.22
Gigabecquerels (33 millicuries) (Sec. 35.394).
The current rule, in Sec. 35.930, specifies the training
requirements for an authorized user of radiopharmaceuticals for
therapeutic administration of unsealed byproduct material, and, in
Sec. 35.934, specifies the training requirements for use of iodine-131
for the treatment of thyroid carcinoma.
Section 35.930(a) lists four specialist boards through which an
individual may become certified.
Alternatively, Sec. 35.930(b) specifies training and experience
requirements that may be met in lieu of certification by one of the
four listed speciality boards. It currently requires 80 hours of
classroom and laboratory training in specified subjects. In addition,
it requires supervised clinical experience, including use of I-131 for
diagnosis of thyroid function and the treatment of hyperthyroidism or
cardiac dysfunction in 10 individuals and use of I-131 for treatment of
thyroid carcinoma in three individuals.
Section 35.934 specifies that the licensee shall require the
authorized user of only iodine-131 for the treatment of thyroid
carcinoma to be a physician with special experience in thyroid disease
who has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of iodine-131 for treating
thyroid carcinoma and supervised clinical experience consisting of 80
hours of classroom and laboratory training that includes specified
subjects, and also supervised clinical experience under the supervision
of an authorized user that includes the use of iodine-131 for the
treatment of thyroid carcinoma in five individuals.
The final rule creates a new section, Sec. 35.394, providing the
following:
Section 35.394(a) provides that, except as provided in Sec. 35.57,
the licensee shall require an authorized user for the oral
administration of sodium iodide I-131 requiring a written directive in
quantities greater than 1.22 Gigabecquerels (33 millicuries) to be a
physician who is certified by a medical specialty board whose
certification process includes all of the requirements in
Sec. 35.394(c) and whose certification has been recognized by the
Commission or an Agreement State.
Alternatively, Sec. 35.394(b) provides that the licensee shall
require an authorized user to be an authorized user under
Sec. 35.390(a), Sec. 35.390(b) for uses listed in
Sec. 35.390(b)(1)(ii)(G)(2), or equivalent Agreement State
requirements.
Alternatively, Sec. 35.394(c) provides that the licensee shall
require an authorized user to have: (1) successfully completed 80 hours
of classroom and laboratory training in specified subjects; (2) have
work experience under the supervision of an authorized user who meets
specified requirements involving specified activities, including
administering dosages to patients or human research subjects that
includes at least three cases involving the oral administration of
greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-
131; and (3) have obtained written certification, signed by a preceptor
authorized user who meets specified requirements, that the individual
has successfully completed the classroom and laboratory and work
experience requirements and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses authorized under Sec. 35.300.
Cost Impacts: NRC anticipates that the medical boards recognized
under Sec. 35.392 will also seek recognition under this section.
Therefore, no incremental costs will be associated with this section
involving costs to NRC/Agreement States for certifying medical
specialty boards. NRC anticipates costs to the physicians seeking
authorized user status under Sec. 35.394(c) from obtaining the
preceptor's certification.
New costs for securing a preceptor statement under Sec. 35.394(c)
are created by the final rule. However, NRC assumes that candidates
under Sec. 35.394 will also seek to qualify under Sec. 35.392, and
therefore the costs of preceptor certification are reflected under
Sec. 35.392.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
subpart f--manual brachytherapy
5.60 Use of sealed sources for manual brachytherapy (Sec. 35.400).
Section 35.400 currently requires a licensee to use specified
sources for brachytherapy in accordance with the manufacturer's
radiation safety and handling instructions. Section 35.400 approves the
use of seven sealed sources for brachytherapy and specifies how they
may be used (e.g., topically, interstitially).
The final rule amends Sec. 35.400 to eliminate the listing of
permissible sealed sources and therapeutic use specifications. It
replaces the list with the provision that a licensee shall only use
brachytherapy sealed sources for therapeutic medical uses as approved
in the Sealed Source and Device Registry (SSDR) or in research in
accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA provided the requirements of
Sec. 35.49(a) are met.
Cost Impacts: Cost savings are associated with this section in the
final rule. Use of a brachytherapy source or employment of a
brachytherapy therapeutic treatment method not listed in Sec. 35.400
currently requires a license amendment. The final rule eliminates the
need for a licensee to obtain a license amendment to use a source or
therapeutic method not listed in Sec. 35.400. No longer requiring
licensees to submit license amendments if they want to use a source or
therapeutic method not listed in Sec. 35.400 reduces both licensee
costs and NRC and Agreement States costs.
Assumptions:
Licensees: Total number of amendments (10 NRC and 25 Agreement
States licensees): 35; Licensee amendment preparation time, hours: 2;
Technical staff hourly rate: $30; Total Annual Cost Savings for
licensees: $2,000.
NRC/Agreement States: Total license amendment submittals (10 NRC
and 25 Agreement States licensees): 35; NRC/Agreement States amendment
review time, hours: 1; NRC/Agreement States staff hourly rate: $75;
Total Annual Cost Savings for NRC and Agreement States: $2,000; Total
Annual Cost Savings from changes to Sec. 35.400: $4,000.
Health and Safety Impacts: Physicians have a wider range of
therapeutic options and the methods in which the sealed sources can be
used will increase. Use of new or revised techniques no longer require
a license amendment, if the manufacturer updates the SSDR.
Benefits: Improved licensee flexibility and cost savings to
licensees due to the elimination of license amendments.
5.61 Surveys after source implant and removal (Sec. 35.404).
Section 35.404(a) currently specifies that immediately after
removing the last temporary implant source, the licensee must make a
radiation survey of the patient or human research subject to confirm
that all sources have been removed. The final rule provides that a
licensee may not release a patient treated with temporary implants from
confinement for medical care until all sources have been removed.
Section 35.404(b) requires licensees to retain records of surveys.
Section 35.404(a) of the final rule specifies that immediately
after implanting sources, the licensee must make a radiation survey to
locate and account for all sources that have not been implanted. The
final rule in Sec. 35.404(b) specifies that immediately after removing
the last temporary implant source from a patient or a human research
subject, the licensee shall make a radiation survey of the patient or
the human research subject with a radiation detection survey instrument
to confirm that all sources have been removed.
The final rule also eliminates the requirement that patients with
temporary implants cannot be released until all implants have been
removed. In the final rule, all requirements regarding the release of
patients with temporary implants are contained in Sec. 35.75. Section
35.404(c) requires licensees to retain a record of patient or human
research subject surveys in accordance with Sec. 35.2404.
Cost Impacts: Currently, a license amendment is required to allow
for the release from hospital confinement of patients with temporary
implants that have not been removed. The NRC anticipates cost savings
for both licensees and NRC and Agreement States with the changes to
Sec. 35.404 in the final rule eliminating the requirement that the
licensee may not release from confinement a patient or a human research
subject treated by temporary implant until all sources have been
removed. These cost savings result from no longer requiring the
submission of license amendments to allow the release of patients with
temporary implants that have not been removed.
Assumptions:
Licensees: Total number of amendments (10 NRC and 25 Agreement
States licensees): 35; Licensee amendment preparation time, hours: 2;
Technical staff hourly rate: $30; Total Annual Cost Savings for
licensees: $2,000.
NRC and Agreement States: Total license amendment submittals (10
NRC and 25 Agreement States licensees): 35; NRC/Agreement States
amendment review time, hours: 1; NRC/Agreement States staff hourly
rate: $75; Total Annual Cost Savings for NRC and Agreement States:
$3,000; Total Annual Cost Savings from changes to Sec. 35.404: $5,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings and reduced regulatory burden due to the
elimination of license amendments.
5.62 Brachytherapy sources accountability (Sec. 35.406).
Section 35.406(a) currently requires a licensee to return
brachytherapy sources to the storage area promptly after removal and to
count the number of sealed sources to ensure all sources taken from the
storage area have been returned. Sections 35.406(b)(1)-(3) describe the
specific records that must be kept concerning the use of the source.
Section 35.406(c) requires a radiation survey of the patient and area
of use immediately following a source implantation and Sec. 35.406(d)
mandates that these inventory and survey records must be kept for 3
years.
The final rule, in Sec. 35.406, eliminates the requirement for a
count of sources returned to the storage area. The final rule
eliminates detailed specifications for the source inventory and survey
requirements of the current rule. The final rule removes the
requirement for a radiation survey immediately following a source
implant from Sec. 35.406(c) of the current rule and moves it to
Sec. 35.404(a) of the final rule.
Section 35.406(a) of the final rule requires licensees to maintain
accountability at all times for all brachytherapy sources in storage or
use.
Section 35.406(b) of the final rule requires licensees to return
brachytherapy sources to a secure storage area, as soon as possible
after removing sources from a patient or a human research subject.
Section 35.406(c) of the final rule requires that licensees make a
record of brachytherapy source accountability in accordance with
Sec. 35.2406.
Cost Impacts: None anticipated. Licensees continue to be required
to maintain accountability for each brachytherapy source.
Health and Safety Impacts: None anticipated. Licensees continue to
be required to maintain records so that, if a brachytherapy source is
misplaced or missing, the licensee is immediately alerted and can take
appropriate action.
Benefits: Improved flexibility for licensees.
5.63 Safety instruction (Sec. 35.410).
Section 35.410 currently requires that radiation safety instruction
be given to all personnel caring for patients or human research
subjects undergoing implant therapy. Sections 35.410(a)(1)-(5) specify
the subjects that must be covered in the instruction. Section 35.410(b)
requires that records of individuals receiving instruction must be
retained for 3 years.
The final rule amends Sec. 35.410(a) to specify that radiation
safety instruction must be provided to all personnel caring for
patients who are receiving brachytherapy and cannot be released under
Sec. 35.75, and to require that the instruction be given ``initially
and at least annually.'' The instruction must be ``commensurate with
the duties of the personnel.'' Sections 35.410(a)(1)-(5) specifies the
topics for instruction. Section 35.410(a)(5) adds a requirement that an
authorized user, as well as the RSO or the RSO's designee, be notified
if the patient or human research subject has a medical emergency or
dies. Section 35.410(b) requires records to be maintained in accordance
with Sec. 35.2310.
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Increased radiation safety.
5.64 Safety precautions (Sec. 35.415).
Currently, Sec. 35.415(a)(1) requires that implant patients
confined to medical care may not be quartered with other hospital
patients not receiving radiation therapy. Section 35.415(a)(2)
stipulates that a sign ``Radioactive Materials'' and a note must be
posted on an implant patient's door or chart regarding visiting
instructions. Section 35.415(a)(3) requires that requests by minors to
visit implant patients must be reviewed on a case-by-case basis by the
authorized user in consultation with the RSO. Radiation surveys
immediately following the implantation of a brachytherapy source to
demonstrate compliance with 10 CFR Part 20 are required by
Sec. 35.415(a)(4) and immediate notification of the RSO upon patient
death or patient medical emergency is required by Sec. 35.415(b).
The final rule, in Sec. 35.415(a), requires for each patient or
human research subject who is receiving brachytherapy and cannot be
released in accordance with Sec. 35.75, a licensee shall: (1) not
quarter the patient or the human research subject in the same room as
an individual who is not receiving brachytherapy; (2) visibly post the
patient's or human research subject's room with a ``Radioactive
Materials'' sign; and (3) note on the door or in the patient's or human
research subject's chart where and how long visitors may stay in the
patient's or human research subject's room. Section 35.415(b) of the
final rule requires licensees to have available, near each treatment
room, emergency response equipment to respond to a source dislodged
from the patient and lodged within the patient following removal of the
source applicators. Section 35.415(c) provides that the licensee notify
an authorized user and the RSO, or his or her designee, as soon as
possible, if the patient or human research subject has a medical
emergency or dies.
Cost Impacts: None anticipated.
Health and Safety: Safety will be enhanced by assuring that both
the authorized user and the RSO must be notified.
Benefits: Enhanced safety and increased flexibility for licensees.
5.65 Possession of survey instrument (Sec. 35.420).
The current rule, in Sec. 35.420, requires each licensee to have in
its possession a portable radiation detection survey instrument.
The final rule eliminates Sec. 35.420.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated because licensees will
continue to meet the requirements in 10 CFR 20.1501 and 20.1502 and 10
CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.66 Calibration measurements of brachytherapy sources (Sec. 35.432).
The final rule adds a new section, Sec. 35.432(a), that requires
that before the first medical use of a brachytherapy source a licensee
shall determine the source output or activity using a dosimetry system
that meets the requirements of Sec. 35.630(a) and determine source
positioning accuracy within applicators. Section 35.432(a)(3) requires
these determinations to be made using published protocols accepted by
nationally recognized bodies. Alternatively, Sec. 35.432(b) of the
final rule allows the licensee to use measurements provided by the
source manufacturer or by a calibration laboratory accredited by the
American Association of Physicists in Medicine that are made in
accordance with Sec. 35.432(a). Section 35.432(c) requires the licensee
to mathematically correct the outputs or activities determined under
paragraph (a) for physical decay at intervals consistent with one
percent physical decay. Section 35.432(d) requires that records of
these calibration measurements be retained by licensees in accordance
with Sec. 35.2432.
NRC assumes that sources now provided by the manufacturer have been
calibrated by the manufacturer in accordance with the requirements and
licensees can rely on this calibration. Each licensee that chooses to
calibrate its sources itself is estimated to spend approximately $1,000
annually to perform these calibrations and may need to purchase a new
source calibration unit. Twenty percent of licensees are expected to
calibrate sources currently in inventory or receive sources that
require calibration.
Cost Impacts: Cost increases are anticipated from requirements in
Sec. 35.432 that require licensees using long-lived radionuclides to
calibrate their sources. Only a very few of the affected licensees are
not expected to have access to such a device and will need to purchase
a new source calibrating unit.
Assumptions:
Licensees: Licensees purchasing source calibration device \14\: 51;
Average cost of new source calibration unit \15\: $6,400; Total Cost
Increase from Purchasing New Source Calibration Units: $326,000.
---------------------------------------------------------------------------
\14\ 145 licensees in Program Codes 2210, 2230, and 2231 may need
to own a calibrating unit for the first time. Adjusting by 2.5 to
account for Agreement States yields 507. It was assumed that 10 percent
of this number would not already own a calibrating unit and would need
to purchase one.
\15\ Personal communications with several manufacturers resulted in
estimated prices for calibration units ranging from almost $6,000 to
almost $7,000. An average rate of $6,400 per unit was used.
---------------------------------------------------------------------------
Cost increases are anticipated from requiring licensees using long-
lived radionuclides to calibrate their sources.
Assumptions:
Licensees: Licensees calibrating sources \16\: 422; Annual source
calibration cost: $1,000; Total Annual Cost Increase from source
calibration: $422,000; Total Annual Cost Increase for Sec. 35.432:
$748,000.
---------------------------------------------------------------------------
\16\ 974 licensees in Program Codes 2110, 2120, and 2200 could
perform brachytherapy. Assuming 60 percent actually do brachytherapy
yields 584. Twenty licensees in Program Code 2210 also perform
brachytherapy. Adjusting by 2.5 to account for Agreement States yields
2114. Twenty percent, or 422, are expected to calibrate sources
currently in inventory or receive sources that require calibration.
---------------------------------------------------------------------------
Health and Safety Impacts: Enhanced safety. A required calibration
measurement of brachytherapy sealed sources is expected to help ensure
that the sealed source dose that is administered matches the prescribed
dose.
Benefits: Enhanced safety.
5.67 Decay of strontium-90 sources for ophthalmic treatments
(Sec. 35.433).
The final rule adds a new section, Sec. 35.433, that provides that
only an authorized medical physicist shall calculate the activity of
each strontium-90 source that is used to determine the treatment times
for ophthalmic treatments. The decay must be based on the activity
determined under Sec. 35.432.
Section 35.433(b) provides that the licensee shall retain a record
of the activity of each strontium-90 source in accordance with
Sec. 35.2433.
Cost Impacts: Cost increases are anticipated from requiring that an
authorized medical physicist must perform activity calculations.
Assumptions:
Licensees: Licensees for Strontium-90 eye applicators: 70; Medical
physicist services: 1 hour/week/licensee at $100 per hour; Total Cost
Increase for Sec. 35.433: $364,000.
Health and Safety Impacts: Enhanced safety.
Benefits: Enhanced safety.
5.68 Therapy-related computer systems (Sec. 35.457).
The final rule adds a new section, Sec. 35.457, that provides that
the licensee shall perform acceptance testing on the treatment planning
system in accordance with published protocols accepted by nationally
recognized bodies. The section specifies that at a minimum the
acceptance testing must include, as applicable: (1) verification of the
source-specific input parameters required by the dose calculation
algorithm; (2) the accuracy of dose, dwell time, and treatment time
calculations at representative points; (3) the accuracy of isodose
plots and graphic displays; and (4) the accuracy of the software used
to determine radioactive source positions from radiographic images.
Cost Impacts: Minimal cost increases are anticipated from this
section of the final rule because licensees currently perform
acceptance testing according to procedures established by software
providers.
Health and Safety Impacts: Enhanced safety.
Benefits: Enhanced safety.
5.69 Training for use of manual brachytherapy sources (Sec. 35.490).
The current rule, in Sec. 35.940, specifies the training
requirements for an authorized user of brachytherapy sources.
Section 35.940(a) lists four specialist boards through which an
individual may become certified to become an authorized user of
brachytherapy sources.
Section 35.940(b) specifies training and experience requirements
that may be met in lieu of certification by one of the five listed
speciality boards. It currently requires 200 hours of classroom and
laboratory training in specified subjects. In addition, it requires 500
hours of specific, supervised work experience. Finally, the current
rule also requires 3 years of supervised clinical experience to
include: (1) examining individuals and reviewing their case histories
to determine their suitability for brachytherapy treatment, and any
limitations or contradictions; (2) selecting the proper manual
brachytherapy sources and dose and method of administration; (3)
calculating the dose; and (4) post-administration follow up and review
of case histories in collaboration with the authorized user.
The final rule creates a new Sec. 35.490 providing the following:
The list of four approved speciality boards is eliminated. Section
35.490(a) provides that, except as provided in Sec. 35.57, the licensee
shall require an authorized user of a manual brachytherapy source for
the uses authorized under Sec. 35.400 to be a physician who is
certified by a medical specialty board whose certification process
includes all of the requirements in Sec. 35.490(b) and whose
certification has been recognized by the Commission or an Agreement
State.
Alternatively, Sec. 35.490(b) provides that the licensee shall
require an authorized user to have: (1) completed a structured
educational program in basic radionuclide handling techniques
applicable to the use of manual brachytherapy sources that includes 200
hours of classroom and laboratory training in specified subjects; (2)
500 hours of work experience under the supervision of an authorized
user who meets the requirements in Sec. 35.490 or equivalent Agreement
State requirements at a medical institution involving specified
activities; and (3) obtained 3 years of supervised clinical experience
in radiation oncology under an authorized user who meets the
requirements in Sec. 35.490 or equivalent Agreement State requirements,
as part of a formal training program approved by the Residency Review
Committee for Radiation Oncology of the Accreditation Council for
Graduate Medical Education or the Committee on Postdoctoral Training of
the American Osteopathic Association. This experience may be obtained
concurrently with the supervised work experience. In addition, the
physician must obtain written certification, signed by a preceptor
authorized user who meets the requirements in Sec. 35.490 or equivalent
Agreement State requirements, that the individual has satisfactorily
completed the requirements in Sec. Sec. 35.490(b)(1) and (b)(2) and has
achieved a level of competency sufficient to function independently as
an authorized user of manual brachytherapy sources for the medical uses
authorized under Sec. 35.400.
Cost Impacts: NRC anticipates incremental costs associated with
recognizing specialty boards. NRC also anticipates costs to the
physicians seeking authorized use status under Sec. 35.490(b) for
obtaining a preceptor certification.
NRC estimates that approximately 150 physicians will seek to become
authorized users under Sec. 35.490 or equivalent Agreement State
regulations annually. Of these, 95 percent, or 143, will seek
certification by a certifying board under Sec. 35.490(a). No additional
cost impacts will be created for them under the final rule. NRC
estimates that the remainder, or approximately seven physicians, will
seek to become authorized users under Sec. 35.490(b). New costs for
securing a preceptor statement will be created by the final rule.
Assumptions:
NRC/Agreement States: Number of boards reviewed: 3; NRC/Agreement
States review time: 4 hours/board at $75 per hour; Total Cost Increase
for Sec. 35.490(a): $1,000.
The costs to applicants associated with securing a preceptor's
certification for purposes of Sec. 35.490(b) are estimated below.
Assumptions:
Licensees: Number of candidates: 7; Cost per preceptor statement
(\1/2\ hour of preceptor's time plus \1/2\ hour of candidate's time):
$60; Total Cost Increase for Sec. 35.490(b): <$1,000; Total Cost
Increase for Sec. 35.490: $1,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
5.70 Training for ophthalmic use of strontium-90 (Sec. 35.491).
The current rule, in Sec. 35.941, specifies the training
requirements for ophthalmic use of strontium-90.
Section 35.941 of the current rule provides that, except as
provided in Sec. 35.970, the licensee shall require the authorized user
of only strontium-90 for ophthalmic radiography to be a physician who
has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of strontium-90 for
ophthalmic radiotherapy, and supervised clinical training in ophthalmic
radiotherapy that includes: (1) 24 hours of classroom and laboratory
training in specified subjects; and (2) supervised clinical training in
ophthalmic radiotherapy under the supervision of an authorized user at
a medical institution that includes the use of strontium-90 for the
ophthalmic treatment of five individuals that includes examination of
each individual to be treated, calculation of the dose to be
administered, administration of the dose, and follow-up and review of
each individual's case history.
The final rule creates a new Sec. 35.491 providing the following:
Section 35.491 substitutes Sec. 35.57 for Sec. 35.970 in the
initial sentence, but otherwise incorporates the requirements in the
current Sec. Sec. 35.941(a) and (b) into the final rule's
Sec. Sec. 35.491 (a) and (b), respectively. A new paragraph,
35.491(b)(3) is added, requiring an individual to obtain written
certification, signed by a preceptor authorized user who meets the
requirements in Sec. Sec. 35.490, 35.491, or equivalent Agreement State
requirements, that the individual has successfully completed the
requirements in Sec. 35.491 and has achieved a level of competency
sufficient to function independently as an authorized user of
strontium-90 for ophthalmic use.
Cost Impacts: NRC anticipates incremental costs associated with
recognizing specialty boards. NRC also anticipates costs to the
physicans seeking authorized user status for obtaining a preceptor
certification. NRC estimates that approximately 15 physicians will seek
to become authorized users under Sec. 35.491 or equivalent Agreement
State regulations annually. All will incur costs for securing a
preceptor statement.
The costs to applicants associated with securing a preceptor's
certification for purposes of Sec. 35.491(c) are estimated below.
Assumptions:
Licensees: Number of candidates: 15; Cost per preceptor statement
(\1/2\ hour of preceptor's time plus \1/2\ hour of candidate's time):
$60; Total Cost Increase for Sec. 35.491(c): $1,000; Total Cost
Increase for Sec. 35.491: $1,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
subpart g--sealed sources for diagnosis
5.71 Use of sealed sources for diagnosis (Sec. 35.500).
Section 35.500 currently requires a licensee to use specified
sources for diagnosis in accordance with the manufacturer's radiation
safety and handling instructions. Section 35.500 approves four medical
uses of sealed sources for diagnostic procedures and specifies how the
sources may be used.
The final rule, in Sec. 35.500, eliminates the listing of
permissible sealed sources and specifies that a licensee may use only
sealed sources for diagnostic medical uses as approved in the Sealed
Source and Device Registry.
Cost Impacts: The NRC anticipates cost savings with the changes to
Sec. 35.500. No longer requiring licensees to submit license amendments
each time they want to use a source for a specific designated
application not listed in Sec. 35.500 will reduce both licensee costs
and NRC and Agreement States costs.
Assumptions:
Licensee: Total licensees seeking amendments (5 NRC and 13
Agreement States licensees): 18; Licensee amendment preparation time,
hours: 2; Technical staff hourly rate: $30; Total Annual Cost Savings
for licensees: $1,000.
NRC/Agreement States: Total license amendment submittals (5 NRC and
13 Agreement States licensees): 18; NRC/Agreement States amendment
review time, hours: 1; NRC/Agreement States staff hourly rate: $75;
Total Annual Cost Savings for NRC and Agreement States:$1,000; Total
Annual Cost Savings from changes to Sec. 35.500: $2,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings and increased licensee flexibility for
licensees.
5.72 Availability of survey instrument (Sec. 35.520).
The current rule, in Sec. 35.520, requires each licensee to have in
its possession a portable radiation detection survey instrument.
The final rule eliminates Sec. 35.520.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated, because licensees must
continue to meet the requirements in 10 CFR 20.1501 and 20.1502 and 10
CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.73 Training for use of sealed sources for diagnosis (Sec. 35.590).
The current rule, in Sec. 35.950, specifies the training
requirements for an authorized user of sealed sources for diagnosis.
Section 35.950(a) lists four specialist boards through which an
individual may become certified to use sealed sources for diagnosis.
Section 35.950(b) specifies training and experience requirements
that may be met in lieu of certification by one of the four listed
speciality boards. It currently requires 8 hours of classroom and
laboratory training in basic radioisotope handling techniques.
The final rule makes the following changes:
The specific list of four approved speciality boards is eliminated.
Section 35.590(a) of the final rule provides instead that the licensee
shall require the authorized user of a diagnostic sealed source for use
in a device authorized under Sec. 35.500 to be a physician, dentist, or
podiatrist who is certified by a speciality board whose certification
process includes all of the requirements in Sec. 35.590(b) and whose
certification has been recognized by the Commission or an Agreement
State.
Alternatively, Sec. 35.590(b), requires 8 hours of classroom and
laboratory training in basic radionuclide handling techniques
specifically applicable to the use of the device that include: (1)
radiation physics and instrumentation; (2) radiation protection; (3)
mathematics pertaining to the use and measurement of radioactivity; (4)
radiation biology; and (5) training in the use of the device for the
uses requested..
Cost Impacts: No cost impacts are expected to be associated with
this section. The medical specialty boards providing certification
under this section are expected to have been recognized under other
sections of the final rule.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
subpart h--photon emitting remote afterloader units, teletherapy units,
and gamma stereotactic radiosurgery units
5.74 Use of a sealed source in a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit (Sec. 35.600).
Section 35.600 currently regulates the use of teletherapy units for
medical use that contain a sealed source of cobalt-60 or cesium-137.
The final rule amends the title and text of Sec. 35.600 to include
remote afterloader units and gamma stereotactic radiosurgery units, as
well as teletherapy units, in Subpart H. The final rule eliminates the
references to a sealed source of cobalt-60 or cesium-137 and specifies
instead that a licensee shall use sealed sources in photon emitting
remote afterloader units, teletherapy units, or gamma stereotactic
radiosurgery units: (1) as approved in the Sealed Source and Device
Registry; or (2) in research in accordance with an effective
Investigational Device Exemption (IDE) application accepted by the FDA
provided the requirements of Sec. 35.49(a) are met.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Improved flexibility for licensees.
5.75 Surveys of patients and human research subjects treated with a
remote afterloader unit (Sec. 35.604).
The final rule adds a new Sec. 35.604 pertaining to radiation
surveys for remote afterloaders. Section 35.604(a) requires that before
releasing a patient or human research subject from licensee control, a
licensee shall survey the patient or the human research subject and the
remote afterloader unit with a portable radiation detection survey
instrument to confirm that the source(s) has been removed from the
patient or human research subject and returned to the safe shielded
position. Section 35.604(b) requires licensees to retain a record of
these surveys in accordance with Sec. 35.2404.
Cost Impacts: None anticipated. Requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Improved regulatory efficiency and consistency.
5.76 Installation, maintenance, adjustment, and repair (Sec. 35.605).
Section 35.605 requires that only persons specifically licensed by
the Commission or an Agreement State to perform teletherapy unit
maintenance and repair can: (1) install, relocate, or remove a
teletherapy sealed source or a teletherapy unit that contains a sealed
source; or (2) maintain, adjust, or repair the source drawer, shutter
or other mechanism of a teletherapy unit that could expose the source,
reduce the shielding around the source, or result in increased
radiation levels.
The final rule adds remote afterloader units and gamma stereotactic
radiosurgery units to the types of units covered by this section.
Section 35.605(a) provides that only a person specifically licensed by
the Commission or an Agreement State shall install, maintain, adjust,
or repair a remote afterloader unit, teletherapy unit, or gamma
radiosurgery unit that involves work on the source(s) shielding, the
source(s) driving unit, or other electronic or mechanical component
that could expose the source(s), reduce the shielding around the
source(s), or compromise the radiation safety of the device or the
source(s).
Section 35.605(b) of the final rule provides that except for low
dose-rate remote afterloader units, only a person specifically licensed
by the Commission or an Agreement State shall install, replace,
relocate, or remove a sealed source or source contained in other remote
afterloader units, teletherapy units, or gamma stereotactic units.
A new Sec. 35.605(c) is added to provide that only a person
specifically licensed by NRC or an Agreement State or an authorized
medical physicist shall install, replace, relocate, or remove a sealed
source(s) contained in a low dose-rate remote afterloader unit.
A new Sec. 35.605(d) provides that a record of installation,
maintenance, adjustment, and repair of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units must be
retained in accordance with Sec. 35.2605.
Cost Impacts: None anticipated. Section 35.605(a) makes no change
with respect to teletherapy. It adds requirements for high dose-rate,
medium dose-rate, and pulsed dose-rate remote afterloaders and gamma
stereotactic radiosurgery. However, these requirements are consistent
with current license conditions.
Section 35.605(c) creates a new exemption for low dose-rate remote
afterloaders from the requirement that maintenance and repair personnel
must be specifically licensed, by providing that authorized medical
physicists may install, replace, relocate, or remove sources contained
in low dose-rate remote afterloaders. This is anticipated to provide a
small savings for licensees using a new source for every treatment.
Health and Safety Impacts: No health or safety impacts are
anticipated. Maintenance and repair will continue to be performed only
by qualified personnel.
Benefits: Improved flexibility and a small cost savings for
licensees.
5.77 License amendments (Sec. 35.606).
The current Sec. 35.606 requires a licensee to apply for and
receive a license amendment before making any change in the treatment
room shielding; making any change in the location of the teletherapy
unit within the treatment room; using the teletherapy unit in a manner
that could result in increased radiation levels in areas outside the
teletherapy treatment room; relocating the teletherapy unit; or
allowing an individual not listed on the licensee's license to perform
the duties of the teletherapy physicist.
The final rule eliminates Sec. 35.606.
Cost Impacts: No significant cost impacts are anticipated.
Health and Safety Impacts: None anticipated. Occupational exposure
and control of exposure and control of access continue to be covered by
the requirements of 10 CFR Part 20.
Benefits: Improved flexibility for licensees.
5.78 Safety procedures and instructions for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units
(Sec. 35.610).
Section 35.610 currently establishes safety instruction
requirements for teletherapy units. Section 35.610(a) requires that
instructions regarding the proper operation of a teletherapy unit must
be posted at the unit console. In addition, Sec. 35.610(b) requires
that operators of teletherapy units receive instruction. Section
35.610(c) requires that records of individuals receiving training must
be kept for 3 years.
The final rule amends the title and text of Sec. 35.610. Section
35.610(a) requires that licensees secure the unit, the console, the
console keys, and the treatment room when not in use or unattended;
permit only individuals approved by the authorized user, Radiation
Safety Officer, or authorized medical physicist to be present in the
treatment room during treatment with the source(s); prevent dual
operation of more than one radiation producing device in a treatment
room if applicable; and develop, implement, and maintain written
procedures for responding to an abnormal situation when the operator is
unable to place the source(s) in the shielded position, or remove the
patient or human research subject from the radiation field with
controls from outside the treatment room. New paragraphs (a)(4)(i)
through (iii) specify what the procedures must include.
New Sec. 35.610(b) provides that a copy of the procedures required
by paragraph (a)(4) must be physically located at the unit console.
Section 35.610(c) requires licensees to post instructions at the
unit console for individuals who operate the devices. These
instructions inform the operator of the location of the procedures
required by Sec. 35.610(a)(4) and the names and telephone numbers of
the authorized users, the authorized medical physicist, and the RSO to
be contacted if the unit or console operates abnormally.
Section 35.610(d) requires licensees to provide instruction,
initially and at least annually, to all individuals who operate the
unit, as appropriate to the individual's assigned duties, in the
procedures required by paragraph (a)(4) and the operating procedures
for the unit.
Section 35.610(e) requires licensees to ensure that operators,
authorized medical physicists, and authorized users participate in
drills of the emergency procedures, initially and at least annually.
Section 35.610(f) requires licensees to retain a record of
individuals receiving instruction required by Sec. 35.610(d), in
accordance with Sec. 35.2310.
Section 35.610(g) requires licensees to retain a copy of the
procedures required by Sec. Sec. 35.610(a)(4) and (d)(2) in accordance
with Sec. 35.2610.
Cost Impacts: No incremental costs are associated with Sec. 35.610.
These requirements are consistent with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory efficiency and consistency, as a result of
codifying requirements previously used as license conditions.
5.79 Safety precautions for remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units (Sec. 35.615).
Section 35.615 currently specifies detailed access controls and
equipment requirements, including radiation monitoring equipment, for
teletherapy rooms. In particular, Sec. 35.615(a) requires access
control to teletherapy rooms and Sec. 35.615(b) requires an electrical
interlock system. Section 35.615(c) requires licensees to equip each
entrance to the teletherapy room with a beam condition indicator light
and Sec. 35.615(d) requires licensees to install in each teletherapy
room a permanent radiation monitor capable of continuously monitoring
beam status. Section 35.615(e) requires that each teletherapy room will
be constructed or equipped to permit continuous observation of the
patient or human research subject from the teletherapy unit console
during irradiation.
The final rule amends the title of the section to specify that the
section pertains to remote afterloader units, teletherapy units, and
gamma stereotactic radiosurgery units. It eliminates requirements for
equipping each entrance with a beam condition indicator light,
permanent radiation monitoring, and associated record keeping
requirements. The final rule also adds requirements for viewing and
intercom systems for all modalities except low dose-rate remote
afterloaders.
Section 35.615(e) provides that for licensed activities where
sources are placed within the patient's or human research subject's
body, a licensee shall only conduct treatments which allow for
expeditious removal of a decoupled or jammed source.
Sections 35.615(f)(1)-(4) establish requirements pertaining to
remote afterloaders and gamma stereotactic radiosurgery units. Section
35.615(f)(1) requires for medium dose-rate and pulsed dose-rate remote
afterloader units that an authorized medical physicist and either an
authorized user or a physician, under the supervision of an authorized
user, who has been trained in the operation and emergency response for
the unit to be physically present during the initiation of all patient
treatments involving the unit; and an authorized medical physicist and
either an authorized user or an individual, under the supervision of an
authorized user, who has been trained to remove the source
applicator(s) in the event of an emergency involving the unit, to be
immediately available during continuation of all patient treatments
involving the unit.
Section 35.615(f)(2) requires for high dose-rate remote afterloader
units that an authorized user and an authorized medical physicist be
physically present during the initiation of all patient treatments
involving the unit; and that an authorized medical physicist and either
an authorized user or a physician, under the supervision of an
authorized user, who has been trained in the operation and emergency
response for the unit, be physically present during continuation of all
patient treatments involving the unit.
Section 35.615(f)(3) requires for gamma stereotactic radiosurgery
units that an authorized user and an authorized medical physicist be
physically present throughout all patient treatments involving the
unit.
Section 35.615(f)(4) requires the licensee to notify the Radiation
Safety Officer, or his/her designee, and an authorized user as soon as
possible if the patient or human research subject has a medical
emergency or dies.
Section 35.615(g) requires applicable emergency response equipment
to be available near each treatment room to respond to a source
remaining in the unshielded position; or lodged within the patient
following completion of the treatment.
Cost Impacts: The elimination of requirements in Sec. Sec. 35.615
(a)-(e) of the current rule for beam condition indicator lights and
permanent radiation monitoring are expected to be offset by new
requirements for viewing and intercom systems. Therefore, no
incremental cost impacts are expected from revisions to these sections.
In addition, 10 CFR 20.1601 continues to require control measures for
high radiation areas.
Future cost savings are expected to be associated with
Sec. 35.615(f)(1). Under the final rule, an authorized user is allowed
to leave a medium or pulsed dose-rate remote afterloader treatment
following the treatment's initialization if a medical physicist and
either an authorized user or an individual under the supervision of an
authorized user who has been given specified training is immediately
available during continuation of the patient treatment. Currently, the
authorized user is required to remain for the duration of the
procedure. Future cost savings will result from increased use of pulsed
dose-rate and medium dose-rate remote afterloaders, which are used
infrequently at present, and from the opportunity to rely on less
expensive staff for immediate response availability.
Costs savings are expected to be associated with Sec. 35.615(f)(2).
Under the final rule, an authorized user will be allowed to leave a
high dose-rate remote afterloader procedure following procedure
initialization if a physician with remote afterloader emergency
response training is available to observe the procedure. Currently, the
authorized user is required to remain for the duration of the
procedure. Other requirements are consistent with current license
conditions. Cost savings will result from the opportunity to rely on
less expensive staff to be present during continuation of treatments
involving the HDR afterloader.
Assumptions:
Licensees: Number of annual HDR treatment fractions (35,000
procedures with 4 fractions per procedure): 140,000; Time to complete
fraction after initiation, hours: 0.0667; Net reduction in hourly rate
\17\: $20; Total Annual Cost Savings from Sec. 35.615: $187,000.
---------------------------------------------------------------------------
\17\ Difference between authorized user physician at $100/hour and
a non-authorized user physician at $80/hour.
---------------------------------------------------------------------------
Health and Safety Impacts: None anticipated.
Benefits: Improved flexibility and cost savings for licensees.
5.80 Possession of survey instrument (Sec. 35.620).
The current rule, in Sec. 35.620, requires a licensee authorized to
use byproduct material in a teletherapy unit to have in its possession
a portable radiation detection survey instrument.
The final rule eliminates Sec. 35.620.
Cost Impacts: None anticipated, because licensees are expected to
continue to possess survey instruments.
Health and Safety Impacts: None anticipated, because licensees are
expected to continue to meet the requirements in 10 CFR 20.1501 and
20.1502 and 10 CFR 30.33 requiring surveys and monitoring.
Benefits: Increased flexibility for licensees.
5.81 Dosimetry equipment (Sec. 35.630).
Section 35.630(a)(1) of the current rule specifies that dosimetry
equipment must be calibrated after any servicing and every 2 years at a
minimum by the NIST or any calibration laboratory accredited by the
AAPM. Alternatively, Sec. 35.630(a)(2) allows dosimetry equipment to be
calibrated every 4 years and subsequently intercompared at an
intercomparison meeting to dosimetry equipment calibrated within the
past 2 years by NIST or any other calibration laboratory accredited by
AAPM. In addition, the current rule requires that a dosimetry system be
available for spot-check measurements. The spot-check system can be the
same system used to meet the requirements in Sec. 35.630(a). Finally,
Sec. 35.630(c) requires a record of each calibration, intercomparison,
and comparison.
The final rule requires that, except for low dose-rate remote
afterloader sources where the source output or activity is determined
by the manufacturer, a licensee shall have a calibrated dosimetry
system available for use. Section 35.630(a) requires the system to be
calibrated either: (1) using a system or source traceable to the
National Institute of Standards and Technology (NIST) and published
protocols accepted by nationally recognized bodies; or (2) by a
calibration laboratory accredited by the American Association of
Physicists in Medicine (AAPM). The calibration must have been performed
within the previous 2 years and after any servicing that may have
affected system calibration. Alternatively, the system must have been
calibrated within the previous 4 years. Eighteen to 30 months after
that calibration, the system must have been intercompared with another
dosimetry system that was calibrated within the previous 24 months by
the National Institute of Standards and Technology (NIST) or by a
calibration laboratory accredited by the American Association of
Physicists in Medicine (AAPM). The final rule eliminates the
requirement in the current rule that equipment comparison must take
place during an intercomparison meeting.
Section 35.630(b) requires the licensee to have a dosimetry system
available for use for spot-check output measurements, if applicable. To
satisfy this requirement, the system may be compared with a system that
has been calibrated in accordance with Sec. 35.630(a). This comparison
must have been performed within the previous year and after each
servicing that may have affected system calibration. The spot-check
system may be the same system used to meet the requirements of
Sec. 35.630(a).
Section 35.630(c) requires a record of each calibration,
intercomparison, and comparison to be retained in accordance with
Sec. 35.2630.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Increased flexibility for licensees.
5.82 Full calibration measurements on teletherapy units (Sec. 35.632).
Section 35.632 currently requires licensees to perform full
calibration measurements on each teletherapy unit, and provides
specific requirements for such calibration measurements. Section
35.632(d) specifies that the calibration shall be performed according
to certain protocols cited in the regulation.
The final rule amends Sec. 35.632(d) to eliminate the citations to
specific protocols and instead provides that the licensee shall make
full calibration measurements in accordance with ``published protocols
accepted by nationally recognized bodies.''
A new Sec. 35.632(b)(4) requires ``timer accuracy'' instead of
``timer constancy.''
A new Sec. 35.632(e) requires a licensee to mathematically correct
the outputs determined in Sec. 35.632(b)(1) for physical decay for
intervals not exceeding one month for cobalt-60, six months for cesium-
137, or at intervals consistent with one percent decay for all other
nuclides.
A new Sec. 35.632(f) requires full calibration measurements
required by Sec. 35.632(a) and physical decay corrections required by
Sec. 35.632(e) to be performed by the authorized medical physicist.
A new Sec. 35.632(g) requires a licensee to retain a record of each
calibration in accordance with Sec. 35.2632.
Cost Impacts: None anticipated. The requirements in Sec. 35.632 of
the final rule do not differ substantially from the requirements in
Sec. 35.632 of the current rule.
Health and Safety Impacts: None anticipated.
Benefits: The amendment provides greater flexibility to licensees
to adopt calibration protocols and avoid the problem that protocols
cited in 10 CFR Part 35 may become outdated over time. NRC will
experience regulatory efficiencies as a result of not being required to
periodically amend Sec. 35.632.
5.83 Full calibration measurements on remote afterloader units
(Sec. 35.633).
The final rule adds a new section, Sec. 35.633, providing detailed
specifications for calibration measurements on remote afterloaders.
Sections 35.633(a)(1) and (2) of the final rule require full
calibration measurements on a remote afterloader before the first
medical use of the device and before medical use following certain
specified conditions.
Sections 35.633(a)(3) and (a)(4) of the final rule require an
additional calibration at intervals not exceeding one quarter for high
dose-rate, medium dose-rate, and pulsed dose-rate remote afterloaders
with sources whose half-life exceeds 75 days and at intervals not to
exceed 1 year for low dose-rate remote afterloaders.
Section 35.633(b) specifies that full calibration measurements must
include, as applicable, determination of output within specified
limits, source positioning accuracy within specified limits, source
retraction, length of source transfer tubes, timer accuracy and
linearity, length of the applicators; and function of source transfer
tubes, applicators, and transfer tube-applicator interfaces.
Section 35.633(c) requires the licensee to use the dosimetry system
described in Sec. 35.630(a) to measure the output.
Section 35.633(d) requires the licensee to make full calibration
measurements required by Sec. 35.630(a) in accordance with published
protocols accepted by nationally recognized bodies.
Section 35.633(e) specifies that in addition to the requirements
for full calibrations for low dose-rate remote afterloader units in
Sec. 35.633(b), a licensee shall perform an autoradiograph of the
source(s) to verify inventory and source(s) arrangement at intervals
not exceeding one quarter.
Section 35.633(f) specifies that for low dose rate remote
afterloader units, a licensee may use measurements provided by the
source manufacturer that are made in accordance with
Sec. Sec. 35.633(a)-(e).
Section 35.633(g) requires licensees to mathematically correct the
output measurements determined in the full calibration for physical
decay at intervals consistent with one percent physical decay.
Section 35.633(h) provides that the full calibration measurements
and physical decay corrections must to be performed by the authorized
medical physicist.
Section 35.633(i) requires that a record of each calibration must
be kept in accordance with Sec. 35.2632.
Cost Impacts: None anticipated. Requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.84 Full calibration measurements on gamma stereotactic radiosurgery
units (Sec. 35.635).
The final rule adds a new section, Sec. 35.635, that provides
detailed specifications for calibration measurements on gamma
stereotactic radiosurgery units.
Sections 35.635(a)(1) and (2) require full calibration measurements
on a gamma stereotactic radiosurgery unit before the first medical use
of the device and before medical use whenever spot-check measurements
indicate the output differs by more than five percent from the output
obtained at the last full calibration corrected mathematically for
radioactive decay; following replacement of the sources or
reinstallation of the unit in a new location; and following any repair
of the unit that includes removal of the sources or major repair of the
components associated with the source assembly. In addition,
calibrations are required at intervals not exceeding 1 year, with the
exception that relative helmet factors need only be determined before
the first medical use of the helmet and following any damage to a
helmet.
Section 35.635(b) specifies the measurements that need to take
place in the full calibration.
Section 35.635(c) requires that a licensee use the dosimetry system
described in Sec. 35.630(a) to measure the output for one set of
exposure conditions. The remaining measurements required in paragraph
(b)(1) may be made using a dosimetry system that indicates relative
dose rates.
Section 35.635(d) requires full calibration measurements to be in
accordance with published protocols accepted by nationally recognized
bodies.
Section 35.635(e) specifies requirements for mathematical
correction of outputs.
Section 35.635(f) requires that full calibration measurements and
physical decay corrections mandated by Sec. Sec. 35.633(a) and (e),
respectively, must be performed by the authorized medical physicist.
Section 35.635(g) requires that records of calibrations must be
retained in accordance with Sec. 35.2632.
Cost Impacts: None anticipated. Requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.85 Elimination of former Sec. 35.636:
Section 35.636 of the current rule requires that licensees check
all teletherapy operation systems listed in Sec. 35.634(d) promptly
following an installation of a source. A safety check is also required
promptly following a teletherapy unit change pursuant to Sec. 35.606.
Section 35.636(b) stipulates that if a teletherapy unit malfunction is
detected, the device console must be locked in the off position.
Section 35.636(c) requires the retention of records of facility checks
following an installation of a source for 3 years.
The final rule eliminates Sec. 35.636.
Cost Impacts: None anticipated. Requirements from this section are
incorporated into Sec. Sec. 35.642, 35.643, 35.644, and 35.645 of the
final rule.
Health and Safety Impacts: None anticipated.
Benefits: Improved regulatory efficiency by reducing redundancy of
requirements.
5.86 Radiation surveys for teletherapy facilities (Sec. 35.641).
The current rule, in Sec. 35.641, specifies detailed requirements
for radiation surveys for teletherapy facilities.
The final rule eliminates Sec. 35.641.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Increased flexibility for licensees.
5.87 Periodic spot-checks for teletherapy units (Sec. 35.642).
Section 35.634 of the current rule requires periodic spot-checks of
teletherapy units to determine proper unit operation.
The final rule replaces the term ``teletherapy physicist'' with
``authorized medical physicist.''
Section 35.642(a) retains essentially the same requirements as
Sec. 35.634(a) of the current rule, except that Sec. 35.642(a)(1)
requires ``timer accuracy'' instead of ``timer constancy.'' Section
35.642(b) retains the same requirements as Sec. 35.634(b), except that
the final rule requires that the procedures established by the
authorized medical physicist be in writing. The amended Sec. 35.642(c)
eliminates the requirement that the licensee must keep a record of the
reports detailing the results of teletherapy unit periodic spot-checks
for 3 years. Section 35.642(d) retains essentially the same
requirements as Sec. 35.634(d), except that the final rule, in
Sec. 35.642(d)(3), uses the term ``source exposure'' instead of ``beam
indicator'' and Sec. 35.642(d)(4) adds ``intercom systems.'' Section
35.642(d) adds a new requirement for safety spot-checks after each
source installation. Section 35.642(d)(4) also requires the
installation of intercom systems in teletherapy unit treatment rooms.
The final rule provides in Sec. 35.642(e) that if the results of the
checks required in Sec. 35.642(d) indicate the malfunction of any
system, a licensee shall lock the console in the off position and not
use the unit except as may be necessary to repair, replace, or check
the malfunctioning system. Section 35.642(f) requires records of each
spot-check required by Sec. 35.642(a) and Sec. 35.642(d) and a record
of the written procedures established by the authorized medical
physicist for performing spot-checks, required by Sec. 35.642(b), to be
kept in accordance with Sec. 35.2642.
Cost Impacts: No incremental costs are associated with Sec. 35.642.
The requirements are consistent with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.88 Periodic spot-checks for remote afterloader units (Sec. 35.643).
The final rule adds a new section, Sec. 35.643, that provides
detailed specifications for periodic spot-checks for remote afterloader
units.
Section 35.643(a) requires a periodic spot-check for each remote
afterloader facility and on each unit. Section 35.643(a)(1) requires a
spot-check before the first use of a high dose-rate, medium dose-rate,
or pulsed dose-rate remote afterloader on a given day. Section
35.643(a)(2) requires a periodic spot-check before each patient
treatment with a low dose-rate remote afterloader. Section 35.643(a)(3)
requires a periodic spot-check for each facility and unit after each
source installation.
Section 35.643(b) requires a licensee to perform the measurements
required by Sec. 35.643(a) in accordance with written procedures
established by the authorized medical physicist. That individual need
not actually perform the spot-check measurements.
Section 35.643(c) requires the licensee to have the authorized
medical physicist review the results of each spot-check within 15 days
of its completion.
Section 35.643(d) specifies the measurements and the systems that
must be accounted for in a spot-check.
Section 35.643(e) requires that if the results of the checks
required in Sec. 35.643(d) indicate the malfunction of any system, a
licensee shall lock the control console in the off position and not use
the unit except as may be necessary to repair, replace, or check the
malfunctioning system.
Section 35.643(f) requires that a record of spot-checks, required
by Sec. 35.643(d), and a record of the procedures for performing spot-
checks establish by the authorized medical physicist, required by
Sec. 35.643(b), be retained in accordance with Sec. 35.2643.
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.89 Elimination of former Sec. 35.643:
Section 35.643 of the current rule is eliminated in the final rule.
Section 35.643 of the current rule stipulates that if a survey required
under Sec. 35.641 indicates that any individual member of the public is
likely to receive a dose in excess of the limits specified in 10 CFR
20.1301, the licensee shall either equip the unit with stops or add
additional shielding. Sections 35.643(a)(2) and (3) require the
licensee to perform the survey required by Sec. 35.641 again; and
paragraph (3) includes in the report required by Sec. 35.645, the
results of the initial survey, a description of the modification made
to comply with paragraph (a)(1) of Sec. 35.643, and the results of the
second survey.
Section 35.643(b) allows radiation levels to exceed those mandated
by 10 CFR 20.1301 if a license amendment is applied for and issued.
The final rule eliminates the current Sec. 35.643.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated, because 10 CFR Part
20, particularly Subparts C and D, establishing occupational and public
dose limits will continue to apply.
Benefits: Improved flexibility for licensees.
5.90 Periodic spot-checks for gamma stereotactic radiosurgery units
(Sec. 35.645).
Section 35.645, ``Reports of teletherapy surveys, checks, tests,
and measurements,'' of the current rule is eliminated. The final rule
includes a new Sec. 35.645 that requires periodic spot-checks for gamma
stereotactic radiosurgery units.
Section 35.645(a)(1) requires spot-checks of each gamma
stereotactic radiosurgery facility and on each unit monthly.
Section 35.645(a)(2) requires a periodic spot-check for gamma
stereotactic radiosurgery facilities and units before each day of use.
Section 35.645(a)(3) requires spot-checks for gamma stereotactic
radiosurgery facilities and units after each source installation.
Sections 35.645(b)(1) and (b)(2) require an authorized medical
physicist to establish written procedures for performing spot-checks
and to review the results of each spot-check required by
Sec. 35.645(a)(1) within 15 days of its completion. The authorized
medical physicist need not actually perform the spot-check
measurements.
Section 35.645(c)and (d) describe the measurements and the systems
that have to be accounted for in spot-checks. Section 35.645(c)
specifies the requirements for spot-checks under Sec. Sec. 35.645(a)(1)
and Sec. 35.645(d) specifies the requirements for spot-checks under
(a)(2) and (a)(3).
Section 35.645(e) requires the licensee to arrange for repair as
soon as possible of any system identified under paragraph (c) that is
not working properly.
Section 35.645(f) requires that if the results of the checks
required in (d) indicate the malfunction of any system, the licensee
must lock the control console in the off position and not use the unit,
except as necessary to repair, replace, or check the malfunctioning
system.
Section 35.645(g) requires a licensee to retain a record of each
spot-check required by Sec. Sec. 35.645(c) and (d), and a record of the
procedures for performing spot-checks established by the authorized
medical physicist, required by Sec. 35.645(d), in accordance with
Sec. 35.2645.
Cost Impacts: None anticipated. Requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.91 Elimination of the former Sec. 35.645:
Section 35.645 of the current rule requires that records required
by Sec. Sec. 35.636, 35.641, 35.643, and full calibration measurements
required in Sec. 35.632 must be mailed to the appropriate NRC Regional
Office.
The final rule eliminates Sec. 35.645.
Cost Impacts: The elimination of the forwarding requirement results
in savings to licensees, estimated below:
Assumptions:
Licensees: Number of mailings by licensees avoided annually: 60;
Estimated cost per mailing: $20; Total Annual Cost Savings from
elimination of the former Sec. 35.645: $1,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings to licensees.
5.92 Additional technical requirements for mobile remote afterloader
units (Sec. 35.647).
Requirements in the current Sec. 35.647, ``5-year inspection,'' are
moved to Sec. 35.655.
The final rule adds a new section establishing technical
requirements for mobile remote afterloader units. Section 35.647(a) in
the final rule requires all survey instruments to be checked before
medical use at each licensee address of use or on each day of use,
whichever is more frequent, and that all sources be accounted for
before leaving from a client's address of use. Section 35.647(b)
requires checks of each remote afterloader unit before use at each
address of use. Section 35.647(b) specifies the checks that must be
made. Section 35.647(c) requires licensees to ensure overall proper
operation by conducting a simulated cycle of treatment before use at
each address of use. Section 35.647(d) requires that if the results of
the checks required in (b) indicate the malfunction of any system, a
licensee shall lock the control console in the off position and not use
the unit except as may be necessary to repair, replace, or check the
malfunctioning system. Section 35.647(e) requires a record of each
check required by Sec. 35.647(b) be kept in accordance with
Sec. 35.2647.
Cost Impacts: Cost impacts are not anticipated because of the small
number (7) of licensees, and because the requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.93 Radiation surveys (Sec. 35.652).
Currently, Sec. 35.641 requires a radiation survey before medical
use, after each installation of a source in a teletherapy unit, and
after making other changes to a teletherapy unit. Section 35.641(a)
describes the scope of the survey and what operational conditions need
to be verified. Section 35.641(b) requires that the teletherapy unit
control be locked in the off position if the survey indicates that
radiation levels exceed the limit set in 10 CFR 20.1301.
The final rule amends Sec. 35.641 and renumbers it as Sec. 35.652.
Section 35.652(a) of the final rule requires that in addition to the
survey requirement in 10 CFR 20.1501, a person licensed under this
subpart shall make such surveys to ensure that the maximum radiation
levels and average radiation levels from the surface of the main source
safe with the source(s) in the shielded position do not exceed levels
stated in the Sealed Source and Device Registry. Section 35.652(b) of
the final rule requires that licensees make the surveys required in
paragraph (a) at installation of a new source and following specified
repairs. Section 35.652(c) requires licensees to retain records of
radiation surveys in accordance with Sec. 35.2652.
Cost Impacts: None anticipated. Requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.94 Five-year inspection for teletherapy and gamma stereotactic
radiosurgery units (Sec. 35.655).
Section 35.647 of the current rule stipulates that teletherapy
units must be inspected and serviced during teletherapy source
replacement or every 5 years, whichever comes first. Section 35.647(b)
of the current rule requires that this inspection and servicing may
only be performed by a individual licensed by the Commission or
Agreement States.
The final rule amends Sec. 35.647 and renumbers it as Sec. 35.655.
The final rule adds a requirement for inspection and servicing of gamma
stereotactic radiosurgery units during source replacement or every 5
years, whichever comes first. Section 35.655(b) requires that the
servicing must be performed only by persons specifically licensed by
NRC or an Agreement State.
Section 35.655(c) requires that licensees keep a record of
inspection and servicing in accordance with new Sec. 35.2655.
Cost Impacts: None anticipated. Requirements are consistent with
current licensee activities.
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency from including in
regulations requirements that previously had been applied as license
conditions.
5.95 Therapy-related computer systems (Sec. 35.657).
The final rule adds a new Sec. 35.657 requiring licensees to
perform acceptance testing in accordance with published protocols
accepted by nationally recognized bodies. Sections 35.657(a) through
(e) specify the activities that the acceptance testing must include.
Cost Impacts: None anticipated. Licensees using computerized
operating and planning systems currently verify their proper operation
by conducting detailed acceptance testing.
Health and Safety Impacts: Acceptance testing and verification of
correct operation ensure safe operation of these systems.
Benefits: Codifies existing practice.
5.96 Training for use of remote afterloader units, teletherapy units,
and gamma stereotactic radiosurgery units (Sec. 35.690).
The current rule, in Sec. 35.960, specifies the training
requirements for the authorized user of a sealed source in a
teletherapy unit.
Section 35.960(a) lists four specialist boards through which an
individual may become certified to use sealed sources in a teletherapy
unit.
Section 35.960(b) specifies training and experience requirements
that may be met in lieu of certification by one of the four listed
speciality boards. It currently requires 200 hours of classroom and
laboratory training in specified subjects. In addition, it requires 500
hours of specific, supervised work experience. The current rule also
requires 3 years of supervised clinical experience.
The final rule makes the following changes:
The list of four specialist boards is eliminated. Section 35.690
requires that, except as provided in Sec. 35.57, the licensee shall
require the authorized user of a sealed source for a use listed in
Sec. 35.600 to be a physician who is certified by a medical speciality
board whose certification process includes all of the requirements in
Sec. 35.690(b) and whose certification has been recognized by the
Commission or by an Agreement State.
Alternatively, Sec. 35.690(b) provides that the physician must have
completed a structured educational program in basic radionuclide
techniques, including specified areas of training, applicable to the
use of a sealed source in a therapeutic medical unit and must have
completed 200 hours of classroom and laboratory training in specified
topics and 500 hours of work experience, including specified
activities, under the supervision of an authorized user who meets the
requirements in Sec. 35.690 or equivalent Agreement State requirements
at a medical institution; and has completed 3 years of supervised
clinical experience in radiation oncology, under an authorized user who
meets the requirements in Sec. 35.690 or equivalent Agreement State
requirements, as part of a formal training program approved by the
Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or the Committee on Postdoctoral
Training of the American Osteopathic Association. This experience may
be obtained concurrently with the supervised work experience. The
physician also must have obtained written certification that the
individual has satisfactorily completed the requirements in
Sec. Sec. 35.690(b)(1) and (b)(2) and has achieved a level of
competency sufficient to function independently as an authorized user
of each type of therapeutic medical unit for which the individual is
requesting authorized user status. The written certification must be
signed by a preceptor authorized user who meets the requirements in
Sec. 35.690 or equivalent Agreement State requirements for an
authorized user for each type of therapeutic medical unit for which the
individual is requesting authorized user status.
Cost Impacts: The cost impacts of the final rule apply to both NRC/
Agreement States and licensees.
NRC estimates that approximately 150 physicians will seek to become
authorized users under Sec. 35.690 or equivalent Agreement State
regulations annually. Of these, 95 percent, or 143, seek certification
by a certifying board under Sec. 35.690(a). No additional cost impacts
be created for them under the final rule. NRC estimates that the
remainder, or approximately seven physicians, seek to become authorized
users under Sec. 35.690(b). New costs for securing a preceptor
statement are created by the final rule.
The costs to NRC/Agreement States for recognizing specialty boards
for purposes of Sec. 35.690(a) are estimated below. Because of the
complexity of training under this section, NRC has assumed that medical
boards that have sought recognition under other sections may prepare a
separate application under this section.
Assumptions:
NRC/Agreement States: Number of boards: 3; NRC/Agreement States
review time: 4 hours/board at $75 per hour; Total Cost Increase to NRC:
$1,000.
Certifying boards incur costs for preparing a submission supporting
their recognition.
Assumptions:
Certifying Boards: Number of boards reviewed: 3; Preparation of
submission: 12 hours/board for Technical Staffat $30/hour; 4 hours/
board for Management at $100/hour; Total Cost Increase for Certifying
Boards: $2,000; Total Cost Increase for Sec. 35.690(a): $3,000.
The costs to applicants associated with securing a preceptor's
certification for purposes of Sec. 35.690(b) are estimated below.
Assumptions:
Licensees: Number of candidates: 7; Cost per preceptor statement
(\1/2\ hour of preceptor's time and \1/2\ hour of candidate's time):
$60; Total Cost Increase for Sec. 35.690(b): <$1,000; Total Cost
Increase for Sec. 35.690: $3,000.
Health and Safety Impacts: None anticipated.
Benefits: Training and experience commensurate with risk and
focused on radiation safety.
subpart i--[reserved]
subpart j--[reserved]
Subpart J of the current rule establishes training and experience
requirements as follows: Sec. 35.900 Radiation Safety Officer;
Sec. 35.901 Training for experienced Radiation Safety Officer;
Sec. 35.910 Training for uptake, dilution, and excretion studies;
Sec. 35.920 Training for imaging and localization studies; Sec. 35.930
Training for therapeutic use of unsealed byproduct material;
Sec. 35.932 Training for treatment of hyperthyroidism; Sec. 35.934
Training for treatment of thyroid carcinoma; Sec. 35.940 Training for
use of brachytherapy sources; Sec. 35.941 Training for ophthalmic use
of strontium-90; Sec. 35.950 Training for use of sealed sources for
diagnosis; Sec. 35.960 Training for teletherapy; Sec. 35.961 Training
for teletherapy physicist; Sec. 35.970 Training for experienced
authorized users; Sec. 35.971 Physician training in a three month
program; Sec. 35.972 Recentness of training; Sec. 35.980 Training for
authorized nuclear pharmacist; Sec. 35.981 Training for experienced
nuclear pharmacists.
The final rule eliminates Subpart J. Training and experience
requirements in the final rule are in Subparts B and D through H of the
final rule. The cost impacts, health and safety effects, and benefits
of the training and experience requirements in the final rule are
addressed under the relevant sections of the final rule.
subpart k--other medical uses of byproduct material or radiation from
byproduct material
5.97 Other medical uses of byproduct material or radiation from
byproduct material (Sec. 35.1000).
The final rule, in new Sec. 35.1000, provides that a licensee may
use byproduct material or a radiation source approved for medical use
which is not specifically addressed in Subpart D through H of 10 CFR
Part 35 if: (1) the applicant or licensee submits the information
required by Sec. Sec. 35.12 (b) through (d); and (2) the applicant or
licensee receives written approval from the Commission and uses the
material in accordance with the regulations and specific conditions
deemed necessary by the Commission for the medical use of the material.
Cost Impacts: Applicants for other medical uses will need to
prepare and submit information as specified under Sec. Sec. 35.12 (b)
through (d). However, the requirements under Sec. 35.12(d) are an
alternative to the requirements for an exemption under Sec. 35.19 and
are anticipated to provide cost savings. The cost savings are estimated
under Sec. 35.12(d).
Health and Safety Impacts: None anticipated.
Benefits: Regulatory efficiency, as a result of specification of
requirements in advance.
subpart l--records
5.98 Records of authority and responsibilities for radiation protection
programs (Sec. 35.2024).
Section 35.2024(a) requires licensees to retain a record of actions
taken by the licensee's management in accordance with Sec. 35.24(a) for
5 years and specifies the contents of those records. Section 35.2024(b)
requires licensees to retain a copy of both the authority, duties, and
responsibilities of the Radiation Safety Officer, as required by
Sec. 35.24(e), and a signed copy of each RSO's written agreement, as
required by Sec. 35.24(b), for the duration of the license. Section
35.2024 requires the records to include the signature of the Radiation
Safety Officer and licensee management.
Cost Impacts: The final rule reduces the record retention period
for records of actions taken by licensee's management under
Sec. 35.24(a), which under the current rule lasts until the Commission
terminates the license, to 5 years. Therefore, small cost reductions
occur with shorter record retention periods.
Assumptions:
Licensees: Licensees: 5,793; Reduction in storage requirements: 1
cubic foot (about \1/2\ file drawer); Cost of storage: $1.50 per cubic
foot; Total Annual Cost Savings from Sec. 35.2024: $9,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings for licensees.
5.99 Records of radiation protection program changes (Sec. 35.2026).
The final rule, in new Sec. 35.2026, provides that a licensee must
retain a record of each radiation protection program change made in
accordance with Sec. 35.26(a), for 5 years. The record must include a
copy of the old and new procedures; the effective date of the change;
and the signature of licensee management that reviewed and approved the
change.
Section 35.31(b) currently requires that a licensee retain a record
of each ``radiation safety program'' change until the license has been
renewed or terminated. Under the current rule, the record must include
``the effective date of the change, a copy of the old and new radiation
safety procedures, the reason for the change, a summary of radiation
safety matters that were considered before making the change, the
signature of the Radiation Safety Officer, and the signatures of the
affected authorized users and of management or, in a medical
institution, the Radiation Safety Committee's chairman and the
management representative.''
Section 35.26 of the final rule amends Sec. 35.31(b) to eliminate
the quoted requirements and provides that a licensee shall retain a
record of each change in accordance with Sec. 35.2026. The record must
include a copy of the old and new procedures; the effective date of the
change; and the signature of the licensee management who reviewed and
approved the change.
Cost Impacts: Small cost reductions are expected with shorter
record retention periods, as follows:
Assumptions:
Licensees: Total licensees: 5,793; Reduction in storage
requirements: 2 cubic feet (about 1 file drawer); Cost of storage:
$1.50 per cubic foot; Total Annual Cost Savings from Sec. 35.2026:
$17,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings for licensees.
5.100 Records of written directives (Sec. 35.2040).
The final rule, in new Sec. 35.2040, requires licensees to retain a
copy of the written directive, as required by Sec. 35.40, for 3 years.
Cost Impacts: Because the number of procedures requiring written
directives is not expected to change under the requirements of
Sec. 35.40 of the final rule, the scope of the recordkeeping
requirements under Sec. 35.2040 of the final rule is not expected to
change. The final rule requires a 3-year record retention period, which
corresponds to the record retention period for written directives under
the current rule. Therefore, no cost impacts are anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.101 Records for procedures for administrations requiring a written
directive (Sec. 35.2041).
The final rule, in new Sec. 35.2041, requires licensees to retain a
copy of the procedures for administrations requiring a written
directive, as required by Sec. 35.41(a), for the duration of the
license.
Cost Impacts: No cost impacts are anticipated. The requirement in
Sec. 35.2041 to retain a copy of these procedures does not differ from
the current need to retain a copy of the quality management program,
which is implicitly included in the requirement in the current
Sec. 35.32(a) to ``maintain'' a quality management program.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.102 Records of calibrations of instruments used to measure the
activity of unsealed byproduct material (Sec. 35.2060).
The final rule, in new Sec. 35.2060, requires a licensee to
maintain a record of instrument calibrations required by Sec. 35.60 for
3 years and specifies that the records must include the model and
serial number of the instrument, the date of the calibration, the
results of the calibration, and the name of the individual who
performed the calibration.
The final rule uses the phrase ``instrument calibrations.''
Therefore, the scope of the final rule potentially is increased,
through the inclusion of records of calibrations of instruments in
addition to dose calibrators.
Cost Impacts: The final rule is anticipated to result in minimal
(<$1,000) increased recordkeeping costs.
Health and Safety Impacts: None anticipated.
Benefits: The calibration ensures that instruments are functioning
correctly and establishes trends in equipment performance.
5.103 Records of radiation survey instrument calibrations
(Sec. 35.2061).
The final rule, in new Sec. 35.2061, requires a licensee to
maintain a record of radiation survey instrument calibrations required
by Sec. 35.61 for 3 years and specifies the contents of that record.
Cost Impacts: The final rule duplicates the recordkeeping
requirements in Sec. 35.51(d) of the current rule. The record retention
period remains 3 years. Therefore, no cost impacts are anticipated from
the final rule.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.104 Records of dosages of unsealed byproduct material for medical use
(Sec. 35.2063).
The final rule, in new Sec. 35.2063, requires a licensee to
maintain a record of dosage determinations required by Sec. 35.63 for 3
years and specifies the records that must be maintained.
The recordkeeping requirements in the final rule parallel the
recordkeeping requirements in Sec. 35.53 of the current rule. The
record retention period remains 3 years. The final rule makes two
changes: (1) eliminating the requirement that the record contain the
expiration dates of the radiopharmaceutical; and (2) changing
``measurements'' to ``determination'' in Sec. 35.2063(b)(3) of the
final rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.105 Records of leak tests and inventory of sealed sources and
brachytherapy sources (Sec. 35.2067).
The final rule, in new Sec. 35.2067(a), requires records of leak
tests of sealed sources and brachytherapy sources required by
Sec. 35.67(b) of the final rule to be retained for 3 years and
specifies the contents of the records. Section 35.2067(b) requires
records of the semi-annual physical inventory of sealed sources and
brachytherapy sources required by Sec. 35.67(g) of the final rule to be
retained for 3 years and specifies the content of the inventory
records.
Cost Impacts: The final rule duplicates, with one change, the
recordkeeping requirements in Sec. Sec. 35.59(d) and (g) of the current
rule. The final rule reduces the record retention time from 5 years to
3 years. This reduction of the record retention period by 2 years is
expected to result in small cost savings to licensees, as follows:
Assumptions:
Licensees: Licensees: 1,876; Reduction in storage requirements: 1
cubic foot (about \1/2\ file drawer); Cost of storage: $1.50 per cubic
foot; Total Annual Cost Savings from Sec. 35.2067: $3,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings for licensees.
5.106 Records of surveys for ambient radiation exposure rate
(Sec. 35.2070).
The final rule, in new Sec. 35.2070, requires licensees to retain a
record of each survey required by Sec. 35.70 for 3 years. The final
rule parallels the recordkeeping requirements in Sec. 35.70(h) of the
current rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.107 Records of the release of individuals containing unsealed
byproduct material or implants containing byproduct material
(Sec. 35.2075).
The final rule, in new Sec. 35.2075(a), requires a licensee to
retain a record of the basis for authorizing the release of an
individual in accordance with Sec. 35.75 if certain specified
calculations were used. Section 35.2075(b) requires that a record be
retained that the instructions required by Sec. 35.75(b) were provided
to a breast feeding woman if the radiation dose to the infant or child
from continued breast-feeding could result in a total effective dose
equivalent exceeding 5mSv (0.5 rem). Section 35.2075(c) requires
licensees to retain records of patient release required by
Sec. Sec. 35.75(a) and (b) for 3 years after the date of release of the
individual.
Cost Impacts: None anticipated. The recordkeeping requirements in
the final rule parallel the recordkeeping requirements in
Sec. Sec. 35.75(c) and (d) of the current rule. Therefore, no
incremental costs or cost savings are anticipated from the final rule.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.108 Records of mobile medical services (Sec. 35.2080).
The final rule, in new Sec. 35.2080, requires licensees to retain a
copy of the letter(s) that permit the use of byproduct material at a
client's address of use, in accordance with Sec. 35.80(a)(l), for 3
years after the provision of last service. Section 35.2080(a) also
requires the letter to clearly delineate the authority and
responsibility of each entity. Section 35.2080(b) requires licensees to
retain a record of each survey required by Sec. 35.80(a)(4) for 3 years
and specifies the contents of the records.
Cost Impacts: None anticipated. The recordkeeping required in
Sec. 35.2080 of the final rule is also required in Sec. 35.80(f) of the
current rule. Therefore, no incremental costs or cost savings are
anticipated from the final rule.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.109 Records of decay-in-storage (Sec. 35.2092).
The final rule, in new Sec. 35.2092, requires a licensee to
maintain records of the disposal of licensed materials by decay in
storage as permitted by Sec. 35.92 for 3 years. The record must
include: the date of the disposal; the survey instrument used; the
background radiation level; the radiation level measured at the surface
of each waste container; and the name of the individual who performed
the survey.
Cost Impacts: The final rule parallels, with one change, the
recordkeeping requirements in Sec. 35.92 of the current rule. The final
rule eliminates the requirement that the record include the date on
which the byproduct material was placed in storage. Therefore, the
final rule may create small cost savings (i.e., <$1,000) for licensees,
as a result of the slight reduction in the scope of records that must
be maintained.
Health and Safety Impacts: None anticipated.
Benefits: Small cost savings for licensees (<$1,000).
5.110 Records of molybdenum-99 concentrations (Sec. 35.2204).
The final rule, in new Sec. 35.2204, requires licensees to maintain
a record of the molybdenum-99 concentration tests required by
Sec. 35.204(b) for 3 years and specifies the contents of the record.
Cost Impacts: The final rule parallels, with changes, the
recordkeeping requirements in the current rule in Sec. 35.204(c). The
changes in Sec. 35.204 reduce the number of required measurements, thus
reducing the number of records that must be maintained.
Cost savings to licensees are estimated at:
Assumptions:
Licensees: Total licensees: 2,069; Reduction in storage
requirements: 4 cubic feet (about 2 file drawers); Cost of storage:
$1.50 per cubic foot; Total Annual Cost Savings from Sec. 35.2204:
$12,000.
Health and Safety Impacts: None anticipated.
Benefits: Cost savings for licensees.
5.111 Records of safety instruction (Sec. 35.2310).
The final rule, in new Sec. 35.2310, requires a licensee to
maintain a record of safety instructions required by Sec. Sec. 35.310,
35.410, and 35.610 for 3 years. The record must include: a list of
topics covered; the date of the instruction; the name(s) of the
attendee(s); and the name(s) of the individual(s) who provided the
instruction.
The final rule parallels, with one change, the recordkeeping
requirements in the current rule in Sec. Sec. 35.310(b), 35.410(b), and
35.610(c). The final rule eliminates the requirement that the record
include a description of the instruction. Therefore, the final rule
creates small cost savings (i.e., <$1,000) for licensees using unsealed
byproduct material for therapeutic administration, manual
brachytherapy, and teletherapy. However, Sec. Sec. 35.310, 35.410, and
35.610 are amended to require radiation safety instruction ``initially
and at least annually.'' Such annual training, and records of such
training, previously has been required by license condition.
Cost Impacts: Small cost savings are anticipated (<$1,000).
Health and Safety Impacts: None anticipated.
Benefits: Small cost savings to licensees.
5.112 Records of surveys after source implant and removal
(Sec. 35.2404).
The final rule, in new Sec. 35.2404, requires that a licensee
maintain a record of the radiation surveys required by Sec. Sec. 35.404
and 35.604 for 3 years and specifies that each record must contain the
date and results of the survey, the survey instrument used, and the
name of the individual who made the survey.
The final rule slightly reduces the scope of the records that must
be maintained, because licensees for manual brachytherapy are not
required to maintain a record of the dose rate from the patient or
human research subject, as currently required by Sec. 35.404(b).
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.113 Records of brachytherapy source accountability (Sec. 35.2406).
The final rule, in new Sec. 35.2406, requires licensees to maintain
a record of brachytherapy source accountability required by Sec. 35.406
for 3 years and specifies the records that must be maintained.
The final rule reorganizes and reduces the recordkeeping
requirements in Sec. 35.406 of the current rule. The record retention
period does not change.
Section 35.2406(b), which parallels the requirements in the current
rule in Sec. 35.406(b), with changes, specifies requirements for
records of temporary implants. However, it eliminates the requirement
to maintain a record of the name of the individual permitted to handle
the sources; the requirement to record the name and room number of the
patient or human research subject; and the number and activity of
sources in storage after the return of sources after removal from a
patient or human research subject.
Section 35.2406(c), a new paragraph, specifies requirements for
records of permanent implants. It requires the record to include the
number and activity of sources removed from storage and the name of the
individual who removed them from storage; the date they were removed
from storage; the number and activity of sources not implanted; the
date they were returned to storage and the name of the individual who
returned them to storage; and the number and activity of sources
permanently implanted in the patient or human research subject.
The final rule is not expected to increase the scope of the records
that must be maintained, because records of inventory for brachytherapy
sources used for permanent implants are covered, under the current
rule. The final rule is expected to result in small cost savings (i.e.,
<$1,000) for licensees from the reduced scope of the inventory records
that must be maintained.
Cost Impacts: Small cost savings to licensees (<$1,000).
Health and Safety Impacts: None anticipated.
Benefits: Cost savings to licensees.
5.114 Records of calibration measurements of brachytherapy sources
(Sec. 35.2432).
The final rule, in new Sec. 35.2432, requires a licensee to
maintain a record of the calibrations on brachytherapy sources required
by Sec. 35.432 for 3 years after the last use of the source. The final
rule specifies that the record must include: the date of the
calibration; the manufacturer's name, the model number, and serial
number for the source and instruments used to calibrate the source; the
source output or activity; source positioning accuracy within
applicators; and the signature of the authorized medical physicist.
Cost Impacts: The current rule contains no requirements pertaining
to records of full calibrations on brachytherapy sources. Therefore,
this section of the final rule creates small (i.e., <$1,000), new cost
impacts for licensees.
Health and Safety Impacts: Increased safety.
Benefits: Conforming change.
5.115 Records of decay of strontium-90 sources for ophthalmic
treatments (Sec. 35.2433).
The final rule, in new Sec. 35.2433, requires a licensee to
maintain a record of the activity of a strontium-90 source required by
Sec. 35.433 for the life of source. The final rule specifies that the
record must include the date and the initial activity of the source as
determined under Sec. 35.432; and for each decay calculation, the date
and source activity as determined under Sec. 35.433.
Cost Impacts: The current rule contains no requirements pertaining
to records of decay for strontium-90 sources used for ophthalmic
treatments. Therefore, this section of the final rule creates small
(i.e., <$1,000), new cost impacts for licensees.
Health and Safety Impacts: Increased safety.
Benefits: Conforming change.
5.116 Records of installation, maintenance, adjustment, and repair of
remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units (Sec. 35.2605).
The final rule, in new Sec. 35.2605, requires that a licensee
retain a record of the installation, maintenance, adjustment, and
repair of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units as required by Sec. 35.605 for 3 years
and specifies that for each installation, maintenance, adjustment, and
repair, the record must include: the date; description of the service;
and name(s) of the individual(s) who performed the work.
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change resulting from the restructuring of 10
CFR Part 35.
5.117 Records of safety procedures (Sec. 35.2610).
The final rule, in new Sec. 35.2610, requires that a licensee
retain a record of the procedures required by Sec. 35.610(a)(4) for
responding to abnormal situations for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units, and
retain a record of the operating procedures for the unit(s) required by
Sec. 35.610(d)(2), until the licensee no longer possesses the unit(s).
Impacts: None anticipated. These requirements are implicit in
Sec. Sec. 35.610(a)(4) and (d)(2).
Health and Safety Impacts: None anticipated.
Benefits: Regulatory clarity and efficiency. Without this explicit
statement, licensees would have had to reference the general
recordkeeping provisions of Sec. 30.51(b) and therefore, would have had
to retain these procedures for the duration of the license.
5.118 Records of dosimetry equipment used with remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery
units (Sec. 35.2630).
The final rule, in new Sec. 35.2630, requires that a licensee
retain a record of the calibration, intercomparison, and comparisons of
its dosimetry equipment done in accordance with Sec. 35.630 for the
duration of the license and specifies in detail what information must
be included in each of these records.
Cost Impacts: The final rule parallels the recordkeeping
requirements in the current rule in Sec. 35.630. However, the final
rule eliminates the requirement for evidence to be provided that the
intercomparison meeting was sanctioned by a calibration laboratory or
radiologic physics center accredited by AAPM. Therefore, this section
of the final rule creates no new cost impacts for licensees.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.119 Records of teletherapy, remote afterloader, and gamma
stereotactic radiosurgery full calibrations (Sec. 35.2632).
The final rule, in new Sec. 35.2632, requires that a licensee
maintain a record of the teletherapy unit, remote afterloader unit, and
gamma stereotactic radiosurgery unit full calibrations required by
Sec. Sec. 35.632, 35.633, and 35.635 for 3 years and specifies in
detail what information must be included in each of these records.
The final rule parallels, with three exceptions, the recordkeeping
requirements in the current rule in Sec. 35.632(g). The final rule
changes the record retention period from the duration of use of the
teletherapy source to 3 years after the last use of the source. It does
not require maintenance of a record of the model numbers and serial
numbers of the instruments used to calibrate the teletherapy unit. It
refers to the ``authorized medical physicist'' instead of the
``teletherapy'' physicist, to conform to the nomenclature of the final
rule.
Cost Impacts: This section of the final rule creates small
incremental costs (i.e., <$1,000) for licensees as a result of the
increase in the length of the record retention period.
Health and Safety Impacts: None anticipated. Records already being
retained.
Benefits: Demonstrates that calibrations were done correctly and
correct doses administered. Conforming change to restructuring of 10
CFR Part 35.
5.120 Records of periodic spot-checks for teletherapy units
(Sec. 35.2642).
The final rule, in new Sec. 35.2642, requires that a licensee
retain a record of each periodic spot-check for teletherapy units,
required by Sec. 35.642(a) for 3 years; and a copy of the procedures
for performing spot-checks established by the authorized medical
physicist, required by Sec. 35.642(b), until the licensee no longer
possesses the unit. The final rule also specifies in detail what
information must be contained in the records of the spot-checks.
The final rule parallels, with minor changes, the recordkeeping
requirements for periodic spot-checks for teletherapy units in the
current rule in Sec. 35.634(f).
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.121 Records of periodic spot-checks for remote afterloader units
(Sec. 35.2643).
The final rule, in new Sec. 35.2643, requires that a licensee
retain a record of each spot-check for remote afterloaders, required by
Sec. 35.643(a), for 3 years; and retain a copy of the procedures for
performing spot-checks establish by the authorized medical physicist,
required by Sec. 35.643(b), until the licensee no longer possesses the
unit. The final rule also specifies in detail what information must be
contained in the record of each spot-check.
Impacts: None anticipated. The requirements are consistent with
current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.122 Records of periodic spot-checks for gamma stereotactic
radiosurgery units (Sec. 35.2645).
The final rule, in new Sec. 35.2645, requires that a licensee
retain a record of each spot-check for gamma stereotactic radiosurgery
units, required by Sec. Sec. 35.645(c) and (d), for 3 years; and a
record of the procedures for performing the spot-checks established by
the authorized medical physicist, required by Sec. 35.645(b), until the
licensee no longer possesses the unit. The final rule also specifies in
detail what information must be contained in the records of each spot-
check.
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.123 Records of additional technical requirements for mobile remote
afterloader units (Sec. 35.2647).
The final rule, in new Sec. 35.2647, requires that a licensee
retain a record of each check for mobile remote afterloader units
required by Sec. 35.647 for 3 years. The final rule also specifies in
detail what information must be contained in each of these records.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
5.124 Records of surveys of therapeutic treatment units (Sec. 35.2652).
The final rule, in new Sec. 35.2652, requires that a licensee
maintain a record of radiation surveys of treatment units made in
accordance with Sec. 35.652 for the duration of use of the unit and
specifies in detail what information must be included in the record.
The final rule parallels, with changes, the requirements for
records of radiation surveys for teletherapy facilities in Sec. 35.641
of the current rule. The final rule requires records to be maintained
for the duration of use of the unit, rather than for the duration of
the license. It does not require a record to be maintained for why the
survey is required; a plan of the areas surrounding the treatment room
that will be surveyed; the measured dose rate at several points in each
area, or the calculated maximum quantity of radiation over a period of
one week for each restricted and unrestricted area. This section of the
final rules reduce the cost impacts for licensees of teletherapy
sources. The final rule also creates a new regulatory requirement for
other therapy units. However, the net effect is anticipated to be small
(i.e., <$1,000).
Cost Impacts: None anticipated. The requirements are consistent
with current license conditions.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.125 Records of 5-year inspection for teletherapy and gamma
stereotactic radiosurgery units (Sec. 35.2655).
The final rule, in new Sec. 35.2655, requires that a licensee
maintain a record of the 5-year inspection for teletherapy and gamma
stereotactic radiosurgery units required by Sec. 35.655 for the
duration of use of the unit and specifies in detail what information
the record must contain.
The final rule parallels, with changes, the requirements for 5-year
inspections of teletherapy units in Sec. 35.647 of the current rule.
The costs of conducting the inspections are estimated under its
replacement, Sec. 35.655 of the final rule. The final rule requires
records to be maintained for the duration of use of the unit, rather
than for the duration of the license. It does not require a record to
be maintained of the list of components replaced, which lessens the
cost impacts for licensees of teletherapy sources.
Cost Impacts: The current rule does not contain requirements for
records of 5-year inspections for gamma stereotactic radiosurgery
units. A cost increase is anticipated, as follows:
Assumptions:
Licensees: Total licensees: 53; Increase in storage requirements: 2
cubic feet (about 1 file drawer); Cost of storage: $1.50 per cubic
foot; Total Annual Cost Increase from Sec. 35.2655: <$1,000.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change.
subpart m
5.126 Report and notification of a medical event (Sec. 35.3045).
Section 35.3045(a) requires a licensee to report any event, except
for an event that results from patient intervention, in which the
administration of byproduct material or radiation from byproduct
material, results in a dose meeting or exceeding specified criteria in
Sec. Sec. 35.3045(a)(1), (2), or (3). This reporting requirement is
needed to ensure that NRC is aware of medical events and to promptly
take any necessary actions based on the circumstances.
Section 35.3045(b) requires a licensee to report any event
resulting from intervention of a patient or human research subject in
which the administration of byproduct material or radiation from
byproduct material results or will result in unintended permanent
functional damage to an organ or a physiological system, as determined
by a physician
Section 35.3045(c) requires licensees to notify the NRC Operations
Center by telephone no later than the next calendar day after discovery
of the medical event.
Section 35.3045(d) requires licensees to submit a written report to
the appropriate NRC Regional Office within 15 days after the discovery
of the medical event. The report must include: the licensee's name; the
name of the prescribing physician; a brief description of the event;
why the event occurred; the effect, if any, on the individual(s) who
received the administration; what actions, if any, have been taken or
are planned to prevent recurrence; certification that the licensee
notified the individual (or the individual's responsible relative or
guardian); and if not, why not. The report must not contain the
individual's name or any other information that could lead to
identification of the individual. This reporting requirement is needed
to provide NRC a synopsis of the event, its cause(s), and corrective
actions taken, so that NRC can ensure that appropriate follow-up
actions are taken after medical events, and so that NRC can promptly
notify other licensees if it appears the event might be generic.
Section 35.3045(e) requires the licensee to provide notification of
the event to the referring physician and the individual who is the
subject of the medical event, or that individual's responsible relative
or guardian, no later than 24 hours after its discovery, unless the
referring physician personally informs the licensee either that he or
she will inform the individual or that, based on medical judgment,
telling the individual be harmful. The licensee is not required to
notify the individual without first consulting the referring physician.
If the referring physician or the affected individual cannot be reached
within 24 hours, the licensee shall notify the individual as soon as
possible thereafter. If a verbal notification is made, the licensee is
required to inform the individual, or appropriate responsible relative
or guardian, that a written description of the event can be obtained
from the licensee upon request. The licensee then must provide such a
written description if requested. Individuals and their referring
physician(s) need this information to make timely decisions regarding
possible health care needs.
Section 35.3045(f) specifies that aside from the notification
requirement, nothing in Sec. 35.3045 affects any rights or duties of
licensees and physicians in relation to each other, to individuals
affected by the medical event, or to that individuals responsible
relatives or guardians.
Section 35.3045(g) provides that a licensee shall annotate a copy
of the report provided to the NRC with the name of the individual who
is subject to the event, and their social security number or other
identification number, if one has been assigned. The licensee shall
provide a copy of the annotated report to the referring physician, if
other than the licensee, within 15 days after discovery of the medical
event.
Cost Impacts: None anticipated. The changes in Sec. 35.3045 of the
final rule are not expected to substantially change the number or type
of medical events to be reported under Sec. 35.3045 from the number and
type of misadministrations reported under the current rule. The
deletion of the requirement to maintain a record of the
misadministration (medical event) is not expected to have a significant
cost impact because a report still needs to be prepared and sent to the
NRC and to the referring physician.
Health and Safety Impacts: None anticipated.
Benefits: Reduced prescriptiveness as to providing written report
or description of the medical event to the individual verbally
notified.
5.127 Report and notification of a dose to an embryo/fetus or a nursing
child (Sec. 35.3047).
Section 35.3047(a) requires the licensee to report to NRC any dose
to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent
that is the result of an administration of byproduct material or
radiation from byproduct material to a pregnant individual unless the
dose to embryo/fetus was specifically approved, in advance, by the
authorized user.
Section 35.3047(b) requires the licensee to report to NRC any dose
to a nursing child that is the result of an administration of byproduct
material to a breast-feeding individual that is greater than 50 mSv (5
rem) total effective dose equivalent or has resulted in unintended
permanent functional damage to an organ or a physiological system of
the child, as determined by a physician. This report is needed so that
NRC can comply with the legislative intent of Section 208 of the Energy
Reorganization Act of 1974 (P.L.93-438) as amended, which requires NRC
to submit reports of unintended radiation exposure to Congress.
Section 35.3047(c) requires the licensee to notify by telephone the
NRC Operations Center no later than the next calendar day after
discovery of a dose to the embryo/fetus or nursing child that requires
a report under Sec. Sec. 35.3047(a) or (b). This reporting requirement
is needed to ensure that NRC is aware of unintended radiation exposure
to an embryo/fetus or nursing child and can promptly take any necessary
actions based on the circumstances.
Section 35.3047(d) requires the licensee to submit a written report
to the appropriate NRC Regional Office within 15 days after discovery
of a dose to the embryo/fetus or nursing child that requires a report
under Sec. Sec. 35.3047(a) or (b). The written report must include: the
licensee's name; the name of the prescribing physician; a brief
description of the event; why the event occurred; the effect, if any,
on the embryo/fetus or nursing child; what actions, if any, have been
taken or are planned to prevent recurrence; and certification that the
licensee notified the pregnant individual or mother (or the mother's or
child's responsible relative or guardian), and if not, why not. The
report must not contain the individual's or child's name or any other
information that could lead to identification of the individual or
child. This reporting requirement is needed to provide information to
NRC about the causes of the unintended radiation exposure to an embryo/
fetus or nursing child and methods to prevent recurrence.
Section 35.3047(e) requires the licensee to provide notification of
the event to the referring physician and also notify the pregnant
individual or mother no later than 24 hours after discovery of an event
that requires reporting under paragraph (a) or (b) of this section,
unless the referring physician personally informs the licensee either
that he or she will inform the mother, or that, based on medical
judgment, telling the mother be harmful. The licensee is not required
to notify the mother without first consulting the referring physician.
If the referring physician or mother cannot be reached within 24 hours,
the licensee shall make the appropriate notifications as soon as
possible thereafter. The licensee may not delay any appropriate medical
care for the embryo/fetus or for the nursing child, including any
necessary remedial care as a result of the event, because of any delay
in notification. The licensee can demonstrate compliance with this
paragraph by notifying the mother's or child's responsible relative or
guardian. If a verbal notification is made, the licensee is required to
inform the mother, or the mother's or child's responsible relative or
guardian, instead of the mother, that a written description of the
event can be obtained from the licensee upon request. The licensee then
must make such a written description available if requested.
Section 35.3047(f) provides that a licensee shall annotate a copy
of the report provided to the NRC with the name of the individual who
is subject to the event, and their social security number or other
identification number, if one has been assigned. The licensee shall
provide a copy of the annotated report to the referring physician, if
other than the licensee, within 15 days after discovery of the medical
event.
Cost Impacts: Cost increases are anticipated from requirements in
Sec. 35.3047(a) that require licensees to report a dose to an embryo/
fetus and requirements in Sec. 35.3047(b) that require licensees to
report a dose to a nursing child. NRC anticipates that 10 such
administrations occur annually for NRC and Agreement States licensees.
Costs are addressed under Sec. Sec. 35.3047(c) and (d).
Cost increases are anticipated from requirements in Sec. 35.3047(c)
that require licensees to notify by phone the NRC Operation Center
within five days after discovery of a dose to an embryo/fetus or
nursing child. NRC anticipates that 10 such administrations occur
annually for NRC and Agreement States licensees.
Assumptions:
Licensees: Total annual reports: 10; Total phone reporting time,
hours: 0.5; Technical staff hourly rate: $30; Total Annual Cost
Increase for licensees from Sec. 35.3047(c): <$1,000.
Cost increases are anticipated from requirements in Sec. 35.3047(d)
that require licensees to submit a written report to the appropriate
NRC Regional Office within 30 days after discovery of a dose to the
embryo/fetus or nursing child. NRC anticipates that 10 such
administrations occur annually for NRC and Agreement States licensees.
Assumptions:
Licensees: Total annual licensee administrations: 10; Total report
preparation time, hours: 8; Technical staff hourly rate: $30; Total
Annual Cost Increase for licensees from Sec. 35.3047(d): $2,000.
Cost increases are anticipated from requirements in
Sec. Sec. 35.3047(e) and (f) that require notification to the referring
physician and also to the mother. NRC anticipates that 10 such
notifications occur annually for NRC and Agreement States licensees.
Assumptions:
Licensees: Total annual licensee notifications: 10; Total
notification time, hours: 2.5; Technical staff hourly rate: $30; Total
Annual Cost Increase for licensees from Sec. Sec. 35.3047(e) and (f):
$1,000; Total Annual Cost Increase for licensees from Sec. 35.3047:
$4,000.
Health and Safety Impacts: Provides notification of such events to
individual and to referring physician.
Benefits: Provides NRC with information to comply with Section 208
of the Energy Reorganization Act and to determine the nature and
frequency of such events.
5.128 Report of a leaking source (Sec. 35.3067).
This section requires that licensees file a written report within
five days if a leak test required by Sec. 35.67 reveals the presence of
185 Bq (0.005 microcurie) or more of removable contamination. The
report must be filed with the appropriate NRC Regional Office, with a
copy to the Director, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC. The report must
include the model number and serial number, if assigned, of the leaking
source; the radionuclide and its estimated activity; the results of the
test; the date of the test; and the action taken. This report enables
NRC to promptly determine if the necessary follow-up actions are
necessary following discovery of the leaking source.
Cost Impacts: None anticipated.
Health and Safety Impacts: No health and safety impacts are
anticipated.
Benefits: Conforming change.
subpart n--enforcement
The final rule amends the former Subpart K and retitles it as
Subpart N and makes the following changes:
5.129 Violations (Sec. 35.4001).
Section 35.990 of the current rule specifies that the Commission
may obtain an injunction or other court order to prevent specified
violations.
The final rule renumbers Sec. 35.990 as new Sec. 35.4001, without
other changes.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.130 Criminal penalties (Sec. 35.4002).
Section 35.991(a) of the current rule specifies that the Atomic
Energy Act of 1954, as amended, provides for criminal sanctions for
willful violation of, or attempted violation of, or conspiracy to
violate, any regulation issued under specified sections of the Act.
Section 35.991(b) lists the regulatory sections that are not covered by
criminal sanctions.
The final rule renumbers Sec. 35.991 as Sec. 35.4002 and makes
conforming changes to the section numbers in the final rule.
Cost Impacts: None anticipated.
Health and Safety Impacts: None anticipated.
Benefits: Conforming change to restructuring of 10 CFR Part 35.
5.131 Dose limits for individual members of the public (10 CFR
20.1301).
10 CFR 20.1301(a) of the current rule provides that each licensee
shall conduct operations so that certain dose limits are maintained for
members of the public.
The final rule amends 10 CFR 20.1301(a) to add a new paragraph,
20.1301(c), that provides that, notwithstanding the requirements in
paragraph (a)(1), a licensee may permit visitors to an individual who
cannot be released, under Sec. 35.75, to receive a radiation dose
greater than (1 mSv) 0.1 rem, but not to exceed (5 mSv) 0.5 rem, if the
authorized user, as defined in 10 CFR Part 35, has determined before
the visit that it is appropriate .
The final rule addresses a Petition for Rulemaking (PRM-20-24)
dated April 7, 1996, from the University of Cincinnati. On June 21,
1996 (61 FR 31874), the NRC published a notice of receipt and a request
for comment on the petition (PRM-20-24). All commenters agreed with the
petitioner that it was unreasonable to require licensees to limit doses
to specified visitors to the public dose limit of 1 mSv (0.1 rem). A
draft rulemaking plan was prepared and provided to the Agreement States
on May 1, 1997, for review and comment, and a final rulemaking plan was
submitted to the Commission for approval on August 1, 1997. The NRC
determined that the following alternatives should be evaluated:
<bullet> Alternative 1: retain the 1 mSv (0.1 rem) public dose
limit
This alternative evaluates the cost effectiveness of retaining the
current dose limit of 1 mSv (0.1 rem) to an individual exposed to a
hospitalized radiation patient. The petition would be denied on the
basis that there are sufficient provisions within 10 CFR 20.1301(c) to
allow case-by-case use of the 5 mSv (0.5 rem) annual dose limit for
visitors of radiation patients.
<bullet> Alternative 2: 5 mSv (0.5 rem) public dose limit for
specified visitors of radiation therapy patients
This alternative incorporates the provisions requested by the
petitioner and evaluates the cost effectiveness of amending 10 CFR
20.1301 to permit, on a case-by-case basis, consenting adult,
nonpregnant visitors to receive up to 5 mSv (0.5 rem) in a year from
exposure to radiation therapy patients and to direct the authorized
user to provide basic radiation safety instruction to visitors to
minimize their doses while visiting the patient and require licensees
to badge those visitors whose total effective dose equivalent exceed 1
mSv (0.1 rem).
<bullet> Alternative 3: 5 mSv (0.5 rem) public dose limit for
visitors of radiation patients without badging or recordkeeping
This alternative evaluates the cost effectiveness of amending 10
CFR 20.1301 to permit visitors to individuals who are not released in
accordance with Sec. 35.75 to receive a radiation dose greater than 1
mSv (0.1 rem) but not to exceed 5 mSv (0.5 rem) if the authorized user
determines that it is appropriate. No visitor badging or recordkeeping
would be required in this alternative.
Cost Impacts: Costs of safety instructions: Alternatives 1 and 3
have no requirement for providing ALARA instructions to either the
hospitalized patient or the visitor to the radiation patient and
therefore have no related cost. However, the final rule associated with
Alternative 2 would impose additional costs for providing basic
radiation safety instruction to the 4,650 patients and 9,300 visitors.
A cost of $22 per radiation patient or $102.3 thousand per year is the
estimated total cost of providing instruction for Alternative 2. This
estimate, obtained from NUREG-1492 (NRC 1997), assumes that the
licensee spends 10 minutes providing instruction to the patient and
visitors.
Costs of recordkeeping: Alternatives 1 and 3 have no recordkeeping
requirements and therefore have no related costs. However, the final
rule associated with Alternative 2 would impose additional paperwork
and recordkeeping requirements on the estimated 1,350 licensees (NRC-
and Agreement States-licensed) that provide therapeutic administrations
of radiopharmaceuticals to hospitalized patients. A record documenting
the receipt of informed consent from the visitor to potentially receive
up to the 5 mSv (0.5 rem) dose limit, receipt of basic safety
instruction, and external radiation dosimetry records must be
maintained for 3 years. It is estimated that approximately 4,650
procedures per year would be subject to these requirements. A cost of
$17 per radiation patient or $79.1 thousand per year is the estimated
total cost for record keeping. This estimate, obtained from NUREG-1492
(NRC 1997), assumes that the licensee spend 8 minutes per patient
documenting the provisions of instruction and dosimetric monitoring.
Costs of Providing Dosimetry: Alternatives 1 and 3 have no
dosimetry requirements, and therefore, have no related costs. However,
the final rule associated with Alternative 2 would impose new dosimetry
and paperwork requirements on the estimated 1,350 licensees (NRC- and
Agreement States-licensed) that provide diagnostic and therapeutic
administrations of radiopharmaceuticals to hospitalized patients. The
cost of the dosimeter and dosimeter processing is estimated at $2.50
each. Labor associated with TLD or film badge issuance to and return
from the visitor, and badge receipt from and shipment to a NVLAP
accredited processing contractor is estimated at $14.00. A cost of
$16.50 per visitor is estimated. This results in an annual estimated
cost of approximately $153,400.
Qualitative Benefits: Retention of patients in a hospital by design
necessitates that the patient be ``isolated'' and that human contact,
inclusive of family members, is either minimized or avoided. This
isolation may bring about numerous changes and impositions in the lives
of the patient and family members. The deterioration in the quality of
life brought on by illness is frequently referred to as an ``intangible
cost.'' For thyroid cancer or thyroid dysfunction requiring therapeutic
doses of I-131, for example, a deterioration in the quality of life may
be precipitated by the loss of bodily function, a lifetime dependence
on medication, hormonal instability, uncertainty of normal life-
expectancy, disruption of normal daily routines, and reduced financial
security related to employment, lost earnings, and medical expenses.
While some of these elements of intangible costs are the result of
the disease itself, others such as disruption of normal routines,
social isolation, and enhanced financial strain are clearly elements of
psychological costs that are directly related to patient retention.
Allowing greater visitor access to the patient while they are under
licensee control will provide an unquantifiable amount of physical and
emotional benefit to the patient and the visitor alike. However, the
conversion of this benefit into an equivalent dollar amount is complex,
highly subjective, and dependent upon the individual situation.
Instead, this analysis uses a qualitative and reasonable approach to
scope the range of possible responses.
Health and Safety: Selection of the 5 mSv (0.5 rem) total effective
dose equivalent per year criterion is consistent with: (1) the
Commission's provision in 10 CFR 20.1301(c) for authorizing a licensee
to operate up to this limit; (2) the recommendations of the
International Commission on Radiological Protection (ICRP) in ICRP
Publication 60, ``1990 Recommendations of the International Commission
on Radiological Protection''; (3) the recommendations of the NCRP in
NCRP Report No. 116, ``Limitation of Exposure to Ionizing Radiation'';
and (4) the International Atomic Energy Agency (IAEA) in Safety Series
No. 115, ``International Basic Safety Standards for Protection Against
Ionizing Radiation and for the Safety of Radiation Sources.'' Each of
these documents provides a basis for allowing visitors to radiation
patients to receive annual doses up to 5 mSv (0.5 rem).
The ICRP recommends that dose limits should not be applied to
medical exposures, if the medical exposure is intended to provide a
direct benefit to the exposed individual and the dose is kept as low as
is compatible with the medical purposes. In this instance, medical
exposure is defined to include ``exposures incurred by individuals as
part of their own medical diagnosis and treatment and to exposures
(other than occupational) incurred knowingly and willingly by
individuals helping in the support and comfort of patients undergoing
diagnosis and treatment.''
Current NCRP guidance regarding radiation protection dose limits
(NCRP Report No. 116) recommends that any activity which involves
radiation exposure must be justified on the basis of the expected
benefits to society exceeding the overall cost, the total societal
detriment is maintained ALARA, economic and social factors are taken
into account, and individual dose limits are applied to ensure that the
procedures of ALARA and justification do not result in individuals
exceeding levels of acceptable risk. Based upon this basic radiation
protection philosophy, NCRP Commentary 11 (1995), ``Dose Limits for
Individuals Who Receive Exposure from Radionuclide Therapy Patients,''
noted that members of a radionuclide therapy patient's family are
likely to perceive that the visitors also will benefit from providing
emotional and physical support to the patient during their treatment,
and these visitors are likely to be willing to bear greater risk in
order to achieve that benefit. Consequently, the NCRP Commentary No. 11
recommends that the dose limit for adult family members \18\ ``exposed
to a radionuclide therapy patient should not exceed 50 mSv annually.
When family members are likely to receive exposures in excess of 5 mSv
annually, they should receive appropriate training and individual
monitoring.''
---------------------------------------------------------------------------
\18\ NCRP Commentary No. 11 defines family member as ``any person
who spends a substantial amount of time in the company of the patient
on a regular basis, providing support and comfort, and whom the patient
considers a member of their `family,' whether by birth, by marriage, or
by virtue of a close, caring relationship.''
---------------------------------------------------------------------------
The IAEA description of dose limits for individual members of the
general public is similar to the recommendations of the ICRP and NCRP.
IAEA-115 specifies that:
II-9. The dose limits set out in this part shall not apply to
comforters or patients, i.e., to individuals knowingly exposed
while voluntarily helping (other than in their employment or
occupation) in the care, support and comfort of patients
undergoing medical diagnosis or treatment, or to visitors of
such patients. However, the dose of any such comforter or
visitor of patients shall be constrained so that it is unlikely
that his or her dose will exceed 5 mSv during the period of the
patient's diagnostic examination or treatment. The dose to
children visiting patients who have ingested radioactive
materials should be similarly constrained to less than 1 mSv.
Preferred Alternative: To determine the preferred alternative, the
costs and benefits that result when Alternatives 2 and 3 are each
compared with Alternative 1 (the status quo) were analyzed. Both
Alternatives 2 and 3 allow greater visitor access to the radiation
patient, hence a larger collective dose is associated with these
alternatives. Any potential detriment associated with this additional
collective dose is offset by the qualitative benefit the patient and
visitor receive under Alternatives 2 and 3. No monetary value was
placed upon the qualitative benefit to either the patient or the
specified visitor under each alternative. However, a net cost is
associated with Alternative 2 to provide visitor badging, instruction
and recordkeeping. No such requirements are associated with Alternative
3. The net cost of Alternative 2, compared to Alternatives 1 or 3, is
anticipated to be $334,800. Evaluating the costs associated with
monitoring individuals versus the benefits at these low doses, required
monitoring is not considered to be justified, although the licensee is
not precluded from monitoring and recording individual doses.
6. costs and benefits for alternatives for revisions to 10 cfr part 35
6.1 Summary of Estimated Annual Costs of Rule
Table 6-1 presents a summary of the estimated values and impacts of
the revisions to 10 CFR Part 35. For each regulatory change described
above, Table 6-1 lists the estimated total costs avoided (-) or total
costs added (+) (i.e., the change in costs from the current rule) for
that section.
Table 6-1.--Summary of the Rule's Cost Effects
----------------------------------------------------------------------------------------------------------------
Change in
Change in NRC and Total
Licensee Agreement Change in
Subpart Section Costs States Costs
(nominal $) Costs (nominal $)
(nominal $)
----------------------------------------------------------------------------------------------------------------
A 35.1 0 0 0
35.2 0 0 0
35.5 0 0 0
35.6 0 0 0
35.7 0 0 0
35.8 0 0 0
35.10 0 0 0
35.11 0 0 0
35.12 -1,000 0 -1,000
35.13 -85,000 -81,000 -166,000
35.14 10,000 12,000 22,000
35.15 0 0 0
35.18 0 0 0
----------------------------------------------------------------------------------------------------------------
B 35.20 0 0 0
35.21 0 0 0
35.22 0 0 0
35.23 0 0 0
35.24 -2,167,000 0 -2,167,000
35.26 -14,000 0 -14,000
35.27 -1,158,000 0 -1,158,000
35.29 0 0 0
35.32 -4,436,000 -1,899,000 -6,335,000
35.33 0 0 0
35.40 0 0 0
35.41 0 0 0
35.49 0 0 0
35.50 5,000 2,000 7,000
35.51 2,000 1,000 3,000
35.55 2,000 1,000 3,000
35.57 0 0 0
35.59 0 0 0
----------------------------------------------------------------------------------------------------------------
C 35.60 -521,000 0 -521,000
35.61 -136,000 0 -136,000
35.63 0 0 0
35.65 -5,000 -11,000 -16,000
35.67 -56,000 0 -56,000
35.69 0 0 0
35.70 0 0 0
35.75 0 0 0
35.80 0 0 0
35.90 0 0 0
35.92 -1,000 -1,000 -2,000
----------------------------------------------------------------------------------------------------------------
D 35.100 0 0 0
35.120 0 0 0
35.190 5,000 2,000 7,000
35.200 0 0 0
35.204 -993,000 0 -993,000
35.205 0 0 0
35.220 0 0 0
35.290 -238,000 0 -238,000
----------------------------------------------------------------------------------------------------------------
E 35.300 0 0 0
35.310 0 0 0
35.315 0 0 0
35.320 0 0 0
35.390 63,000 0 63,000
35.392 3,000 1,000 4,000
35.394 0 0 0
----------------------------------------------------------------------------------------------------------------
F 35.400 -2,000 -2,000 -4,000
35.404 -2,000 -3,000 -5,000
35.406 0 0 0
35.410 0 0 0
35.415 0 0 0
35.420 0 0 0
35.432 748,000 0 748,000
35.433 364,000 0 364,000
35.457 0 0 0
35.490 0 1,000 1,000
35.491 1,000 0 1,000
----------------------------------------------------------------------------------------------------------------
G 35.500 -1,000 -1,000 -2,000
35.520 0 0 0
35.590 0 0 0
----------------------------------------------------------------------------------------------------------------
H 35.600 0 0 0
35.604 0 0 0
35.605 0 0 0
35.606 0 0 0
35.610 0 0 0
35.615 -187,000 0 -187,000
35.620 0 0 0
35.630 0 0 0
35.632 0 0 0
35.633 0 0 0
35.635 0 0 0
35.636 0 0 0
35.641 0 0 0
35.642 0 0 0
35.643 0 0 0
35.645 -1,000 0 -1,000
35.647 0 0 0
35.652 0 0 0
35.655 0 0 0
35.657 0 0 0
35.690 2,000 1,000 3,000
----------------------------------------------------------------------------------------------------------------
J 35.900 0 0 0
35.910 0 0 0
35.920 0 0 0
35.930 0 0 0
35.932 0 0 0
35.934 0 0 0
35.940 0 0 0
35.941 0 0 0
35.950 0 0 0
35.960 0 0 0
35.961 0 0 0
35.980 0 0 0
----------------------------------------------------------------------------------------------------------------
K 35.1000 0 0 0
----------------------------------------------------------------------------------------------------------------
L 35.2024 -9,000 0 -9,000
35.2026 -17,000 0 -17,000
35.2040 0 0 0
35.2060 0 0 0
35.2061 0 0 0
35.2063 0 0 0
35.2067 -3,000 0 -3,000
35.2070 0 0 0
35.2075 0 0 0
35.2080 0 0 0
35.2092 0 0 0
35.2204 -12,000 0 -12,000
35.2310 0 0 0
35.2401 0 0 0
35.2404 0 0 0
35.2406 0 0 0
35.2432 0 0 0
35.2433 0 0 0
35.2605 0 0 0
35.2610 0 0 0
35.2630 0 0 0
35.2632 0 0 0
35.2642 0 0 0
35.2643 0 0 0
35.2645 0 0 0
35.2647 0 0 0
35.2652 0 0 0
35.2655 0 0 0
----------------------------------------------------------------------------------------------------------------
M 35.3045 0 0 0
35.3047 4,000 0 4,000
35.3067 0 0 0
----------------------------------------------------------------------------------------------------------------
N 35.4001 0 0 0
35.4002 0 0 0
10 CFR 20.1301................................................. Alt. 3 0 0 0
------------------------------------------------
Total Cost Savings......................................... $8,836,000 $1,977,000 $10,813,000
----------------------------------------------------------------------------------------------------------------
6.2 Estimated Lifetime Costs of Rule
NRC estimates the revisions to 10 CFR Part 35 will result in total
annual cost savings of $10,813,000. NRC notes, however, that these
estimated cost savings will not necessarily result in lower charges to
licensees.
Based on OMB guidance, lifetime costs are estimated using a seven
percent discount rate, which approximates the marginal pre-tax real
rate of return on an average investment in the private sector in recent
years.
Using both a seven percent discount rate and a 20-year time-horizon
(i.e., base year plus 20), NRC estimates the lifetime cost savings of
revising 10 CFR Part 35 to be approximately $125 million in year 2000
dollars.
7. decision rationale
7.1 Decision rationale for revisions to 10 CFR Part 35
1. Alternative 2 is less expensive than Alternative 1 (status quo).
7.2 Decision rationale for PRM-20-24
1. All of the alternatives are acceptable according to generally
accepted radiation protection principles, such as those expressed by
NRC, NCRP, IAEA and ICRP (see Section 4.3, Evaluation of the
Alternatives with Respect to Accepted Radiation Protection Principles).
2. Alternative 1 (status quo) is the least expensive to the public
compared to Alternative 2, but Alternative 1 also conveys the least
physical and emotional benefit to the patient. If the qualitative
benefits of increased visitor-patient access is overlooked, a benefit
which has not been expressed in dollar terms, the additional cost of
Alternative 2 relative to Alternative 1 is about $334,800 per year. The
preponderance of this additional cost is associated with badging
visitors and providing ALARA instruction.
3. Alternative 1 and Alternative 3 have essentially the same
relative licensee costs. The major difference is the qualitative
benefits that the patient and visitor receive under Alternative 3.
4. Alternative 3 relative to Alternative 2 also has a net cost
differential of $251,050 per year, mostly due to less prescriptive
nature of the alternative in that there is no requirement to provide
dosimetry and basic radiation safety instruction for each visitor and
there are reduced recordkeeping requirements. Also, both Alternative 2
and Alternative 3 bestow similar qualitative benefits to the patient
and visitors because of the increased visitor access. Thus, Alternative
3 is more cost effective in comparison with Alternative 2.
8. implementation
No impediments to implementation of any of the alternatives have
been identified.
9. references
Bernier (1997). Bernier, Donald R., Paul E. Christian, and James K.
Langan, Eds. Nuclear Medicine: Technology and Techniques, Fourth
Edition, 1997, Mosby-Year Book, Inc.
Hendee (1996). Hendee, William R. and Geoffry S. Ibbott. Radiation
Therapy Physics, Second Edition, 1996, Mosby-Year Book, Inc.
IAEA (1996). International Atomic Energy Agency. International
Basic Safety Standards for Protection Against Ionizing Radiation and
for the Safety of Radiation Sources, IAEA Safety Series No. 115 (IAEA,
Vienna, Austria).
ICRP (1991). International Commission on Radiological Protection.
1990 Recommendations of the International Commission on Radiological
Protection, ICRP Publication 60, Annals of the ICRP 21 (Pergamon Press,
New York).
Mettler, F.A., Jr., Christie, J.H., Williams, A.G., Jr., Moseley,
R.D., Jr. and Kelsey, C.A. (1986). ``Population Characteristics and
Absorbed Dose to the Population from Nuclear Medicine: United States--
1982,'' Health Phys. 50, 619-628.
NAS (1996). National Academy of Sciences, Institute of Medicine.
Radiation in Medicine: A Need for Regulatory Reform. National Academy
Press, 1996.
NCRP (1993). National Council on Radiation Protection and
Measurements. Limitations of Exposure to Ionizing Radiation, NCRP
Report No. 116 (National Council on Radiation Protection and
Measurements, Bethesda, Maryland).
NCRP (1994). National Council on Radiation Protection and
Measurements. Consideration Regarding the Unintended Radiation Exposure
of the Embryo, Fetus or Nursing Child, NCRP Commentary No. 9 (National
Council on Radiation Protection and Measurements, Bethesda, Maryland).
NCRP (1995). National Council on Radiation Protection and
Measurements. Dose Limits for Individuals Who Receive Exposure from
Radionuclide Therapy Patients, NCRP Commentary No. 11 (National Council
on Radiation Protection and Measurements, Bethesda, Maryland).
NCRP (1996). National Council on Radiation Protection and
Measurements. Sources and Magnitude of Occupational and Public
Exposures from Nuclear Medicine Procedures, NCRP Report No. 124
(National Council on Radiation Protection and Measurements, Bethesda,
Maryland).
NRC (1994). U.S. Nuclear Regulatory Commission. Regulatory Analysis
for Final Amendment to 10 CFR Part 35 ``Quality Management Program and
Mis-administrations.''
NRC (1994/2). U.S. Nuclear Regulatory Commission. Draft Regulatory
Analysis for Proposed Rulemaking Entitled ``Preparation, Transfer for
Commercial Distribution, and Use of Byproduct Material for Medical
Use,'' 10 CFR Parts 30, 32, and 35.
NRC (1994). U.S. Nuclear Regulatory Commission. Regulatory Analysis
on Criteria for the Release of Patients Administered Radioactive
Material, NUREG-1492, Draft Report for Comment (U.S. Government
Printing Office, Washington).
NRC (1997). U.S. Nuclear Regulatory Commission. Regulatory Analysis
on Criteria for the Release of Patients Administered Radioactive
Material, NUREG-1492, Final Report (U.S. Government Printing Office,
Washington).
NRC (1997/2). U.S. Nuclear Regulatory Commission. Revision of Fee
Schedules; 100 percent Fee Recovery, fiscal year 1997, 62 FR 29194, May
29, 1997.
______
Responses by Richard Meserve to Additional Questions
from Senator Voinovich
Question 1. The NRC did a great job processing the first two
license renewal applications at Calvert Cliffs and Oconee within the
planned time. However, you are receiving multiple applications and I
expect you will be receiving even more. What steps are you taking to
ensure that you can process them all without creating a bottleneck at
the NRC? Are there any lessons you learned in the first two
applications which will allow the NRC and the applicants not to
reinvent the wheel for each review?
Response. The NRC recognizes the potential resource impacts of the
unexpected receipt of a large number of renewal applications and has
encouraged licensees to inform the NRC of their plans for license
renewal.
As part of the NRC's efforts to improve its processes, detailed
procedures have been developed to conduct and monitor licensing
actions, including the renewal reviews. The Commission is taking
particular care to ensure that the review of license renewal
applications is focused on those matters relevant to maintaining plant
safety for the extended period of operation.
A standard format has been established for license renewal
applications based on experience with the first reviews. The format is
incorporated into the regulatory guide and standard review plan for
license renewal.
In the summer of 2001, the NRC will issue a revised regulatory
guide and standard review plan for implementing the license renewal
rule, 10 CFR Part 54, that incorporate experience gained from the
review of the first renewal applications. The standard review plan will
also incorporate by reference the Generic Aging Lessons Learned (GALL)
Report. The report documents generically the basis for determining when
existing programs are adequate and when existing programs should be
augmented for license renewal.
Use of the GALL Report will help focus the information provided by
an applicant in a renewal application and the staff's review to areas
where augmentation of an existing program is required or a plant-
specific program is proposed. A reduction in the level of effort needed
to prepare and review a renewal application is expected as a result of
licensee and staff reliance on the GALL report.
The effort expended and outcomes of the license renewal reviews are
being carefully monitored to ensure that the process is effective and
efficient. The NRC's License Renewal Steering Committee is overseeing
the license renewal process to ensure that the license renewal reviews
are timely and efficient.
Lessons learned in the effectiveness and efficiency of the license
renewal reviews continue to be collected so they can be included in
future revisions to the procedures for conducting the license renewal
reviews, changes to the NRC's implementation guidance documents, and
changes to industry guidance.
Question 2a. In a letter from Dr. Edward Silberstein from the
Department of Nuclear Medicine at University Hospital in Cincinnati,
Dr. Silberstein states:
Currently amendments to 10 CFR Part 35 are before OMB for
Review. In my opinion the proposed NRC regulations add to the
cost of health care without improving patient safety. These new
NRC regulations will unnecessarily increase my work burden and
thus increase the costs to patients who benefit from the more
than 13 million procedures (such as cardiac stress tests, lung
scans for pulmonary embolism and bone scans for cancer) we
perform annually using radioactive materials regulated by the
NRC.
Could you comment on this?
Response. The Commission opted to restructure 10 CFR Part 35 into a
more risk-informed, more performance-based regulation by focusing on
those medical procedures that pose the highest risk from a radiation
safety standpoint. Risk information was used to determine what
requirements are necessary to ensure radiation safety during the
medical use of byproduct material. This resulted in reduction of
regulatory burden by eliminating or decreasing the prescriptiveness of
various requirements that apply to the lower-risk area of diagnostic
medical procedures. The procedures mentioned in this question (cardiac
stress tests, lung scans, and bone scans) fall into the lower-risk
category of diagnostic medical procedures where the regulatory burden
was reduced by making the rule more risk-informed and more performance
based. The Final Regulatory Analysis for the 10 CFR Part 35 rulemaking
contains a detailed section-by-section analysis of the costs of the new
rule as compared to the current rule. Summing the new costs and cost
savings, the Final Regulatory Analysis estimates that the revisions to
10 CFR Part 35 will result in a total annual cost savings of $8,836,000
to medical licensees in NRC and Agreement States. The Final Regulatory
Analysis was provided to OMB along with the Part 35 rulemaking for OMB
review.
Question 2b. In a letter from Dr. Edward Silberstein from the
Department of Nuclear Medicine at University Hospital in Cincinnati,
Dr. Silberstein states:
Currently amendments to 10 CFR Part 35 are before OMB for
Review. In my opinion the proposed NRC regulations add to the
cost of health care without improving patient safety. These new
NRC regulations will unnecessarily increase my work burden and
thus increase the costs to patients who benefit from the more
than 13 million procedures (such as cardiac stress tests, lung
scans for pulmonary embolism and bone scans for cancer) we
perform annually using radioactive materials regulated by the
NRC.
I also understand that the NRC ignored the advice of the National
Academy of Science, Institute of Medicine. Could you also comment on
this?
Response. The National Academy of Sciences, Institute of Medicine
(NAS-IOM), study was conducted to provide the NRC with an independent
evaluation of whether the rules, policies, and procedures of the
current regulatory framework for medical uses of byproduct material
fulfilled the NRC's statutory responsibilities for public health and
safety.
In its report, the NAS noted that quantifying levels of risk in
radiation medicine is problematic, and stated that no comprehensive raw
data are available to make exact comparisons. The report did include
risk assessment information addressing the information on comparative
risks of ionizing radiation in medicine. During the rulemaking process,
the Commission comprehensively evaluated and considered all aspects of
the NAS report. Based upon our evaluation, and coupled with comments
received from State and Federal agencies, the Commission determined
that it should remain the lead Federal agency involved in the
regulation of ionizing radiation in medicine.
Question 3. What can Congress and the NRC do to encourage more
generation from our existing nuclear fleet?
Response. At the outset, it is important to recognize that pursuant
to the Energy Reorganization Act of 1974, the NRC's mission is to
ensure the adequate protection of public health and safety, the common
defense and security, and the environment in the application of nuclear
technology for civilian use. The Commission does not have a promotional
role--rather, the agency seeks to ensure the safe application of
nuclear technology.
The Commission recognizes, however, that its regulatory system
should not establish inappropriate impediments to the application of
nuclear technology. As a result, the Commission has implemented or is
in the process of implementing several significant initiatives to
maintain or enhance safety while simultaneously improving the
efficiency and effectiveness of our regulatory system to support more
generation from existing nuclear facilities. Some of the notable
initiatives are the NRC's review of power uprate, and license renewal
applications, reducing unnecessary regulatory burden through risk-
informed regulations and the regulatory oversight process. The
Commission believes that its initiatives should result in achieving
economic efficiency while ensuring safe and reliable operation of
nuclear facilities.
The Commission submitted proposed legislation to Congress that
would help eliminate artificial restrictions and reduce the uncertainty
in the licensing process. Although these changes may have little or no
immediate impact on electrical supply, they would help establish the
context for consideration of nuclear power by the private sector
without any compromise of public health and safety or protection of the
environment. For example:
<bullet> Legislation will be needed to extend the Price Anderson
Act. The Act, which expires on August 1, 2002, establishes a framework
that provides assurance that adequate funds are available in the event
of a nuclear accident and sets out the process for consideration of
nuclear claims. Without the framework provided by the Act, private-
sector participation in nuclear power would be discouraged by the risk
of large liabilities.
<bullet> Commission antitrust reviews could also be eliminated. As
a result of the growth of Federal antitrust law since the passage of
the AEA, the Commission's antitrust reviews are redundant of the
reviews of other agencies. The requirement for Commission review of
such matters, which are distant from the Commission's central
expertise, should be eliminated.
<bullet> Elimination of the ban on foreign ownership of U.S.
nuclear plants would be an enhancement since many of the entities that
are involved in electrical generation have foreign participants,
thereby making the ban on foreign ownership increasingly anachronistic.
The Commission has authority to deny a license that would be inimical
to the common defense and security, and thus an outright ban on all
foreign ownership is unnecessary.
__________
Statement of Joe F. Colvin, President and Chief Executive Officer,
Nuclear Energy Institute
Chairman Voinovich, Ranking Member Lieberman and distinguished
members of the subcommittee, I am Joe Colvin, president and chief
executive officer of the Nuclear Energy Institute, the Washington, DC,
policy organization for the nuclear industry. I am pleased to testify
regarding the performance of the commercial nuclear industry and the
industry's safety regulator, the Nuclear Regulatory Commission.
The Nuclear Energy Institute (NEI) coordinates industry policy on
various issues affecting the nuclear energy industry, including Federal
regulations that help ensure the safety of the 103 commercial nuclear
power plants operating in 31 States. NEI represents 275 companies,
including every U.S. utility licensed to operate a commercial nuclear
reactor, their suppliers, fuel fabrication facilities, architectural
and engineering firms, labor unions and law firms, radiopharmaceutical
companies, research laboratories, universities and international
nuclear organizations.
First, I will provide an overview of the industry's recent
performance. Then I will discuss several topics related to the
regulatory oversight, including:
<bullet> the new reactor oversight process
<bullet> the need for continued regulatory change
<bullet> Federal radiation protection policy
<bullet> renewal of the Price-Anderson Act
<bullet> revisions needed in the Atomic Energy Act
i. nuclear power plants operating at record levels of safety and
efficiency
The industry's performance continues to be outstanding by any
measure. After a decade of steady improvement, U.S. nuclear power
plants achieved record safety and reliability levels in 2000. The
industry set another production record, generating 754 billion
kilowatt-hours--3.5 percent more than in 1999. The average capacity
factor for reactors nationwide in 2000 was nearly 90 percent. A 1,000-
megawatt reactor, operating at 90 percent capacity factor, could
provide electricity for 584,000 people, if all their uses of
electricity are considered (including residential, commercial,
industrial and public sector). That number is roughly equivalent to the
population of Boston, Seattle or Austin, Tex.
The commercial nuclear industry in the United States is a dynamic,
growing sector that has played a key role in the economic growth of our
Nation. The increased electricity generation from nuclear power plants
in the 1990's was equivalent to adding 23 new 1,000-megawatt plants to
our nation's electrical grid. This output satisfied 22 percent of the
increase in U.S. electricity demand that occurred in that decade.
The U.S. Energy Information Administration--in a March report
titled Nuclear Generation: Another Year, Another Record said ``the
increase in nuclear generation over the past 2 years would have been
enough to meet the power needs of all residential consumers in
California in 1999.''
The growth in nuclear electricity production is primarily the
result of two factors. The first is that nuclear plants are operating
more efficiently. Refueling times have decreased and once common
unscheduled shutdowns are rare. The second factor is that many nuclear
plants have undergone equipment uprates, allowing them to produce more
electricity than was initially planned.
There has not been any nuclear plant event that has jeopardized
public health and safety due to the release of radiation in the United
States. Safety at our nation's nuclear power plants remains at record
high levels. In 2000, the median number of unplanned reactor shutdowns
industrywide was zero for the third straight year, and 59 percent of
U.S. reactors had no automatic shutdowns. In addition, the number of
significant events at U.S. nuclear power plants declined to an average
of 0.03 in 2000, compared to 0.44 in 1990. Significant events include a
degradation of important safety equipment, a reactor shutdown with
complications, or operation of the plant outside technical
specifications.
Nuclear power plants are the low-cost leaders in competitive
electricity markets. Production costs at nuclear power plants (1.83
cents per kilowatt-hour) in 1999 were the lowest for any expandable
large electricity source, including coal (2.07 cents) and natural gas
(3.52 cents).
The recent energy shortfalls in some regions of the country have
resulted in a growing recognition that new nuclear power plants will
soon be needed to meet increased demand and to help protect our
nation's air quality. In the January 11 edition of USA Today,
Massachusetts Institute of Technology economics professor Lester Thurow
said:
Americans are not going to go without electricity, and they
aren't going to quit driving . . . In the case of electricity,
we already have a technical solution at hand. It is called
nuclear power.
The industry has been evaluating the business conditions necessary
to build new nuclear plants in the near future. An industry task force
is producing a business plan to chart a course for potential reactor
orders within the next 3 to 5 years.
Today's energy shortfalls are increasing public support for
building new nuclear power plants, according to public opinion surveys
conducted in January and March. The national survey of 1,000 adults
found those in favor of ``definitely building more nuclear energy
plants in the future'' increased from 42 percent in October 1999 to 66
percent in March. The increase was largest in the West, where those in
favor increased from 33 percent in October 1999 to 62 percent.
(Bisconti Research Inc., margin of error <plus-minus>3 percentage
points.)
Federal and State legislators and local government officials, as
well as the national news media, also are reexamining nuclear energy,
and supporting a vital role for the rejuvenated industry.
ii. nuclear generation essential to protecting u.s. air quality
For decades, nuclear energy has played a vital--though largely
unrecognized--role in protecting our air quality. Between 1973 and
1999, nuclear plants avoided the emission of 32 million tons of
nitrogen oxide, 62 million tons of sulfur dioxide and 2.6 billion tons
of carbon.
A few examples will help put these numbers in perspective.
Operating a 1,000-megawatt power plant for 1 hour produces one million
kilowatt-hours of electricity.
<bullet> If the facility is a coal-fired plant, it also produces
265 tons of carbon.
<bullet> If it is an oil-fired plant, it produces 220 tons of
carbon.
<bullet> If it is a gas-fired plant, it produces 150 tons of
carbon.
<bullet> But if it is a nuclear plant, it produces no carbon
whatsoever.
Electric generating facilities have faced significant emission
reduction requirements, especially because large, stationary sources of
emissions are easier to regulate than small or mobile sources. But
electric generating facilities that prevent air pollution to begin
with--such as nuclear power plants--also have played a major role. An
example from the transportation sector will help illustrate the
contribution of avoided emissions due to using nuclear energy in place
of fossil-fired generation. If the United States were to replace all
its nuclear plants with pollution-emitting generation, our nation would
have to take 135 million passenger cars off the road to keep carbon
emissions from increasing. Fortunately, our nation does not have to
make such a choice.
Consider the importance of nuclear energy in three Eastern States:
<bullet> In New Jersey, nuclear power plants accounted for 51
percent of total electricity generation in 1999. They also avoided
substantial emissions: 80,000 tons of nitrogen oxide, 160,000 tons of
sulfur dioxide and nearly 7 million tons of carbon.
<bullet> Nuclear energy generated 47 percent of the electricity in
Connecticut--avoiding the emission of 30,000 tons of nitrogen oxide,
70,000 tons of sulfur dioxide and nearly 3 million tons of carbon.
<bullet> Nuclear energy generated 26 percent of the electricity in
New York, avoiding the emission of 110,000 tons of nitrogen oxide,
200,000 tons of sulfur dioxide and 8.5 million tons of carbon.
For all three States, nitrogen oxide emissions are capped under the
Environmental Protection Agency's ozone transport regulations. If
Connecticut replaced its nuclear-generated electricity with power from
emitting generation, the State's other generating sources would be
under even more pressure to reduce emissions.
New York, New Jersey and 19 other States face the same issue to
varying degrees. These States simply cannot meet the broad spectrum of
clean air requirements unless they use nuclear energy for a substantial
proportion of their electricity generation.
Nuclear energy is the only expandable large-scale source of
electricity that is emission-free. Reports last year from the Energy
Department's Energy Information Administration made a direct connection
between increased production from nuclear plants and the fact that
greenhouse gases and other emissions increased less than they otherwise
would have. Similarly, the Nuclear Energy Agency of the Organization
for Economic Co-operation and Development considers nuclear energy to
be ``consistent with the objectives of sustainable development.''
The nuclear energy industry is a leader in protecting the
environment--managing all its waste and byproducts, with no
uncontrolled discharges of this material. Used fuel is stored onsite,
either in steel-lined pools or in specially designed steel-and-concrete
containers. Byproducts that have low levels of radioactivity are
packaged and sent to licensed disposal facilities designed to handle
such waste.
In addition to helping to preserve our nation's air quality, the
nuclear energy industry is a leader in protecting wildlife habitat,
including the endangered American crocodile, manatee, eagles, osprey
and other animals. Plant owners continually monitor and work to
mitigate the impact of power plant operations on wildlife. For example,
water intake structures have rolling screens to minimize the numbers of
fish that are drawn into the plant cooling water system. On-site
hatcheries replace the few fish that are drawn in. The waterways and
grounds around nuclear plants are sanctuaries for many species of
endangered wildlife.
In short, nuclear energy offers high levels of safety, reliability,
price stability and careful stewardship of the environment. All of this
is included in the cost of electricity from nuclear energy--and even
so, these plants are competitive with other sources of electricity.
iii. nrc reactor oversight process more efficient, more transparent
to the public
Outstanding nuclear power plant safety and performance helped set
the stage for important changes in the regulatory arena. Last April,
the NRC began implementing a new reactor oversight process that builds
on decades of safe nuclear plant operating experience, both within the
agency and the industry. The agency engaged many stakeholders,
including the Union of Concerned Scientists and Public Citizen, in
developing the new approach. The industry believes that the new reactor
oversight process is more effective and efficient than the previous
oversight process because of its sharper focus on those areas of the
plant most important to safety. It also is a major step forward in
making a complex, technical process more transparent to the public.
The baseline program concentrates on plant activities and systems
with the greatest potential impact on public safety and overall risk.
This safety-focused approach is linked to the NRC's three oversight
areas--inspection, assessment and enforcement.
The level of agency resources to be applied in oversight depends on
how a plant performs as measured by the performance indicators and
inspection findings. Performance in each indicator is measured
quarterly and falls into one of four color-coded bands:
<bullet> Green: Performance is within an expected range in which
safety cornerstone objectives are being met.
<bullet> White: Performance is outside an expected range of nominal
utility performance, but related cornerstone objectives are still being
met.
<bullet> Yellow: Related cornerstone objectives are being met, but
with a minimal reduction in safety margin.
<bullet> Red: There has been a significant reduction in safety
margin in the area measured by that performance indicator.
For a program involving change of this magnitude, the initial
implementation has gone well. The process has succeeded in identifying
performance differences among plants from the critically important
perspective of safety. The fourth-quarter 2000 performance indicator
data and inspection findings showed that the vast majority of nuclear
power plants are performing at very high safety levels. Based on the
performance indicator data and inspection findings for the first 9
months \1\ of the program, the NRC concluded that:
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\1\ Two reactors at the D.C. Cook nuclear power station are
excluded because they have not accumulated enough data under the new
process to be representative of their performance.
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<bullet> 73 reactors had all green indicators--the best of four NRC
performance levels--and need the baseline level of inspection;
<bullet> 22 reactors received supplementary inspections because
they received a single white indicator or inspection finding;
performance in the area measured by that indicator is outside the
expected range, but safety objectives are being met; and
<bullet> 6 reactors are receiving more in-depth inspections because
of possible weaknesses in more than one performance area. Nonetheless,
these plants are being operated safely.
The results of the performance assessments are consistent with
nuclear plant performance of the past several years. The new process
makes it much easier for plant operators and the public to see how
nuclear plants are performing and to identify any areas in need of
increased attention. On the NRC's Web site, the public can find the
underlying technical details in a given performance area. Greater
public awareness of how nuclear power plants are regulated was one of
the major goals of the new oversight process, and the NRC should be
commended for its achievement.
The NRC commissioners and staff have shown a strong commitment to
modernizing the agency's regulatory approach. The industry believes
that the NRC's new approach will continue to improve safety performance
by focusing industry and NRC resources on those issues that have the
greatest safety importance. Given this success, the industry encourages
the NRC to develop a safety-focused oversight process for non-reactor
facilities based on similar principles.
iv. need for continued regulatory change
Changes to NRC Regulations
The new oversight process is an enormous improvement over the
agency's former approach to evaluating nuclear plant safety. It is
objective, safety-focused and much more transparent to industry and the
public. But it is only a first step in needed regulatory reform.
Interestingly, the NRC did not have to change any regulations to
implement its new reactor oversight process. However, regulatory
reforms must be codified. The next step is to revise the regulations to
incorporate risk insights and performance-based approaches consistent
with those used in the reactor oversight process.
In creating the new reactor oversight process, the NRC recognized
that not all of its regulations have equal importance--that some
regulations add little or no safety benefit.
The NRC is revising its regulations to make them more safety-
focused, but progress has been slow. A central component of this effort
involves deciding how to treat equipment that previously was
categorized as ``safety-related,'' but which has been proven to have
little or no safety significance.
The industry started designing and building nuclear power plants 40
years ago, without operating experience or the sophisticated analytical
tools we have today. There was at that time some uncertainty associated
with commercial nuclear power plants. Given the limited nuclear plant
operating experience at that time, the industry and Federal regulators
correctly made conservative decisions based on worst-case scenarios. A
very large number of systems and equipment were assumed to have high
safety significance.
Today, we combine more than 2,500 reactor-years of operating
experience with sophisticated computer models for probabilistic safety
assessments. The result is a much higher degree of certainty about how
nuclear plant systems behave and interact under a wide range of
conditions. Recent safety studies have demonstrated that fewer plant
systems and equipment have high safety significance.
The NRC and the industry agree on which equipment has high safety
significance and on how to treat it. We also agree on equipment that is
non-safety-related.
But there is disagreement about how to deal with equipment and
systems categorized since the early years of the industry as safety-
related, but which have been proven to have low safety significance.
The industry believes that commercial industrial standards, not more
stringent nuclear safety standards, should be applied to such
equipment. Commercial industrial standards are widely used in the
nuclear industry, as well as other industries with similar or higher
potential impact on public health and safety.
The cost savings for replacement parts at reactors--and for initial
construction for new reactors--is substantial. For example, an
industrial-grade 10-horse-power electric motor could be purchased for
$350. The same motor, purchased as a safety-related item, would cost 57
times that amount: $20,000. The two pumps perform the same function;
but the cost difference is huge.
Similarly, an industrial-grade electrical circuit card could be
purchased for $1,160. The same circuit card, under nuclear standards,
would cost $5,700--five times as much as the industrial-grade item.
Either component could perform the function for which it is intended.
The main difference in cost is the extent of the process used to
verify the component's performance capability. Commercial industrial
standards are entirely satisfactory for many applications with low
safety-significance in nuclear power plants. In fact, they already are
widely used in these facilities. Their use could be expanded
substantially, and it simply makes sense to do so.
New Nuclear Power Plant Licensing
New nuclear power plants will be needed to meet both electricity
demand and our nation's air quality goals. When the NRC began efforts
to modernize its regulations, the industry believed that the new risk-
informed regulations would provide the framework for licensing new
nuclear power plants. However, a separate rulemaking will be needed for
two reasons:
<bullet> It is the most straightforward approach. Changes to
existing regulations must take into account the outdated assumptions
embedded in the regulations and the plants designed and built to meet
them.
<bullet> The NRC's work on modernizing current regulations is
moving too slowly to be completed in time to license new nuclear power
plants in a more safety-focused manner.
The scientific and technical skills needed to license new nuclear
power plants differ from those needed for oversight of today's nuclear
plants--which has been the NRC's principal activity for the past 15
years--or in license renewal. To review applications for new licenses,
the agency will need geologists, hydrologists, and other scientists.
Current NRC staff may not have the appropriate expertise for this new
function. To prepare for new nuclear power plant construction and
operating license applications, the NRC should examine its staffing and
determine how to fill any gaps in its expertise. Similarly, the
industry, university, Federal agencies and national laboratories must
ensure that we have the expertise and qualified staff for the
development and staffing of future nuclear technologies. The industry
supports a multi-stakeholder effort to attract and retain top caliber
nuclear talent and encourages Congress to continue funding university
programs in nuclear technologies. Congress also should support the
essential role of nuclear energy in the development of national energy
policy as well as legislation introduced this year to support the
development of expertise for the future.
NRC Budget and Staffing
As an independent agency, the NRC was not required to develop a 5-
year, strategic plan--but to its credit, the agency took the initiative
to do so. In the industry's view, the current plan is fundamentally
sound. However, we believe that the plan can be improved further and
used to more directly tie the NRC's strategic goals to its day-to-day
operations. A robust 5-year plan--one that is used to identify goals
and allocate resources--will enhance the agency's effectiveness.
The NRC is facing increased demands on its staff because of license
renewal applications, the development of risk-informed regulations and
the development of regulations to license new plants. Although these
activities will require substantial resources, the industry believes
the NRC's current budget and staffing levels can adequately support
these initiatives if the agency allocates resources on a priority
basis.
The NRC's capability to evaluate nuclear plant systems, structures
and components on a safety-focused basis has demonstrated that the
scope of safety-significant activities is substantially smaller than
previously thought. These insights identify clear opportunities for the
NRC to realign its current resources to face new challenges without
expanding the size of its staff.
The new reactor oversight process demonstrates that nuclear power
plants are performing safely. The few plants that warrant additional
regulatory attention are clearly identified. The level of NRC resources
dedicated to plant inspections should be adjusted to reflect the
priorities identified by the new oversight process. In addition, the
regional deployment of these resources may be no longer appropriate.
The nuclear energy industry is well established, and nuclear assets
are being transferred during a transition to electric utility
restructuring. This has resulted in nuclear plants being operated by a
smaller number of experienced nuclear operating companies, which
operate in multiple regions. We see regional differences in how
inspections are conducted under the new oversight program. These
differences send mixed signals to the management of these companies and
indicate that the regional structure may perpetuate cultural resistance
to the commission's efforts to modernize its regulatory process.
The successful implementation of the revised reactor oversight
process and the natural consolidation of the nuclear industry provide
an opportunity for the commission to re-allocate existing resources to
meet the combined challenge of safety-focusing reactor regulations and
preparing to license new reactor designs.
In short, the NRC should be asked to demonstrate that it is using
its existing staff optimally on matters central to the agency's
statutory mandate--protection of public health and safety--before
asking for additional resources to support new activities.
General Accounting Office Report
The industry's record performance has coincided with several major
regulatory initiatives: the transition to safety-focused regulation,
implementation of the new reactor oversight process and successful
license renewal proceedings.
A recent General Accounting Office (GAO) report--Major Management
Challenges and Performance Risks: Nuclear Regulatory Commission--noted
that the NRC faces challenges of changing its culture to fully support
the safety-focused regulatory concepts reflected in the NRC's new
reactor oversight process. However, GAO expressed concern about the
NRC's ability to continue to ensure safe operation of nuclear
facilities while it is pursuing major change initiatives.
Although that concern is not unreasonable, the record plainly shows
that regulatory reform efforts have had no adverse impact on industry
safety. In fact, the new oversight process has improved safety by more
clearly identifying what is important to safety--and just as important,
what is not.
v. federal radiation protection policy must be based on sound science
As the industry works to increase energy production, it is
committed to maintaining the highest priority on safety. Achieving this
goal depends in large part on the Federal Government's setting a
uniform radiation protection policy. The policy should be based on the
best available science and should be applied equitably and consistently
by every Federal agency across all programs. Duplicative and
conflicting regulation by different agencies, using different criteria,
must be eliminated.
In this area, Federal radiation protection policy falls short. In
fact, a recent report from the General Accounting Office--Radiation
Standards: Scientific Basis Inconclusive, and the EPA and NRC
Disagreement Continues--concluded that U.S. radiation protection
standards ``lack a conclusively verified scientific basis,'' involve
``differing exposure limits'' due to policy disagreements between
Federal agencies, and ``raise questions of inefficient, conflicting
dual regulation.'' A troubling conclusion of the GAO report is that the
costs related to complying with such standards ``will be immense,
likely in the hundreds of billions of dollars'' of private and public
funds.
Two examples of this situation that directly affect consumers
include Federal standards for the decommissioning of NRC-licensed
facilities and for the proposed used nuclear fuel repository at Yucca
Mountain, Nevada. In both cases, the EPA and the NRC have statutory
authority to set radiation standards. The two agencies have taken
fundamentally different regulatory approaches, and the standards they
have set differ accordingly. The NRC has based its standards on sound,
scientific principles, whereas the EPA has stated that its groundwater
policy is based ``on policy, not science.'' \2\ This difference has
complicated development of the Yucca Mountain repository, as well as
facility decommissioning projects by NRC licensees.
---------------------------------------------------------------------------
\2\ This response can be found in written answers dated September
18, 2000, to questions submitted to the EPA by Rep. Joe Barton,
chairman of the Subcommittee on Energy and Power of the Committee on
Commerce.
---------------------------------------------------------------------------
This situation creates significant uncertainties in projecting
costs and schedules. These uncertainties adversely affect a wide range
of decisions, including:
<bullet> Federal budgeting and site suitability for Yucca Mountain;
<bullet> mergers and acquisitions within the electric industry;
<bullet> deregulation of the electricity industry;
<bullet> expansion of nuclear energy through license renewal for
today's plants and the licensing and building of new plants.
Moreover, these negative impacts occur without any demonstrated
positive benefit to public health and safety.
Federal radiation protection policy must provide a foundation to
protect public health and safety, make the best use of public funding
and resources, and help build public trust and confidence in Federal
decisions. Today's conflicting radiation standards and duplicative
regulation work against those principles.
This situation has persisted for years, without any substantial
progress made toward resolution. For example, Senator John Glenn, as
chairman of the Senate Committee on Governmental Affairs, asked the GAO
to report on this issue in 1994. The GAO issued a report in September--
Nuclear Health and Safety: Consensus on Acceptable Radiation Risk to
the Public is Lacking (GAO/RCED-94-190). Senator Pete Domenici
requested a follow-up report in 2000. That report--Radiation Standards:
Inconclusive, and EPA and NRC Disagreement Continues (GAO-00-152)
reflected a situation essentially unchanged. In 6 years, there had been
virtually no progress in resolving the issue.
Congress should resolve the policy issues that the agencies have
not resolved on their own. We encourage this committee to provide
appropriate, continued oversight to ensure that consistent radiation
policy is established through legislation.
vi. price-anderson act must be renewed
The U.S. public has more than $9.5 billion of insurance protection
if an accident were to occur at a commercial nuclear facility. This
entire sum would be paid by the nuclear industry. The framework for
this insurance coverage was established in 1957 by the Price-Anderson
Act, which expires on August 1, 2002. It is a proven system that
Congress should reauthorize. The act requires each nuclear facility to
have that insurance coverage to satisfy its statutory obligations.
Neither taxpayers nor the government pay a cent for this coverage.
Like all the costs of electricity from nuclear power plants, the
costs of Price-Anderson are internalized. That means the nuclear
industry bears the cost of insurance, unlike the corresponding costs of
some major power alternatives.
Risks from dam failure and resultant flooding, for example, are
borne directly by the public. The 1977 failure of the Teton Dam in
Idaho caused $500 million in property damage. The only compensation for
this event was about $200 million made available through low-cost
government loans.
The Price-Anderson Act requires two levels of financial protection.
The primary level provides liability insurance coverage of $200 million
insurance that is purchased by the utilities.\3\ If this amount is not
sufficient to cover claims arising from an accident, a secondary level
applies. For the second level, electric companies that own nuclear
power plants must pay a retroactive premium equal to their
proportionate share of the excess loss. That amount is $10 million per
year, up to a maximum of $88.1 million per reactor. Currently, 106
nuclear reactors participate in the secondary financial protection
program--103 operating reactors and three closed reactors that still
handle used nuclear fuel.
---------------------------------------------------------------------------
\3\ Each utility/company purchases $200 million of primary
insurance per site through American Nuclear Insurers. The total
insurance available--$9.5 billion--includes the primary and secondary
insurance available for an accident at one site.
---------------------------------------------------------------------------
Congress must renew the act this year to ensure that Price-Anderson
coverage will be available to companies that are considering building
new nuclear power plants. Renewal also is vital to Energy Department
contractors, which are indemnified under the Price-Anderson Act.
Nuclear power plants are grandfathered under the act; DOE contractors
are not. The continued operation--and, where necessary, the cleanup--of
Federal sites depends on timely renewal of the Price-Anderson Act's
provisions. Both the Nuclear Regulatory Commission and the Energy
Department have recommended that Congress renew the act. The industry
generally supports the NRC positions on the issue, but differs from the
agency in three important areas:
<bullet> Permanent renewal is preferable to a 10-year renewal. Like
any law, Congress can reconsider this issue if circumstances change.
<bullet> The retrospective premium should remain at $10 million.
The NRC recommends that Congress consider increasing it to $20 million
per reactor from $10 million per reactor. The NRC recommendation was
based, in part, on the assumption that up to 25 current plants would be
retired without relicensing and that the total insurance coverage would
decrease as a result. It now appears that the vast majority of nuclear
plants will pursue license renewal.
<bullet> The level of primary insurance coverage should remain at
$200 million. The NRC recommends that consideration be given to
increasing the primary coverage of insurance to $300 million, but there
is no justification for increasing this insurance coverage.
The industry appreciates this committee's efforts to begin
consideration of this issue in the 106th Congress, with Senator
Inhofe's introduction of S. 2292, the Price-Anderson Amendments Act of
2000.
vii. changes needed to atomic energy act
The industry believes several changes are needed to the Atomic
Energy Act to facilitate reform of the NRC and its regulatory processes
to ensure the effective and efficient regulation of NRC licensees.
Other changes are needed to remove unnecessary impediments that would
inhibit the ability of nuclear power plant operators to make the
transition from a cost-of-service market to a competitive market. The
nuclear industry recommends the following changes:
<bullet> Congress should remove the requirement that the NRC
conduct antitrust reviews. Other Federal agencies conduct such
reviews--notably the Securities and Exchange Commission, the Federal
Trade Commission and the Federal Energy Regulatory Commission. An
additional review by the NRC is unnecessary.
<bullet> Congress should remove the restriction on foreign
ownership of commercial nuclear facilities. NEI supports NRC-proposed
changes to Sections 103d and 104d to clarify that no restrictions
should be placed on the ownership of a production or utilization
facility, except that no license should be issued if such issuance
would be inimical to the common defense and security or public health
and safety.
<bullet> Congress should clarify that the NRC has the discretion to
determine the most appropriate form of hearing to hold in each
circumstance and that the agency is not required to hold adjudicatory
hearings for licensing proceedings unless it determines that such a
proceeding is necessary.
<bullet> Congress should clarify that in the case of a combined
construction and operating license for a nuclear power plant, the start
of the operating license term is keyed to when operation begins, rather
than when the license is initially issued.
<bullet> Congress should authorize the NRC to recover costs from
other Federal agencies for services it provides to those agencies.
<bullet> Congress should clarify that Federal law preempts State
insurance laws and constitutional provisions that would restrict
insurers that satisfy NRC requirements from providing insurance to
nuclear facilities.
<bullet> Congress should give the NRC the legislative authority to
allow the seller of a nuclear power plant to retain a decommissioning
fund even though the seller may no longer be an NRC licensee.
<bullet> The NRC has made considerable progress toward modernizing
its regulatory efforts. NEI supports the elimination of Sections 203,
204, and 205 of the Atomic Energy Act. The commission should be given
the discretion to organize and manage the NRC in the manner it deems
most appropriate.
<bullet> Congress should give the NRC legislative authority over
accelerator-produced radioactive materials. Currently, there is no
Federal guidance for these materials.
<bullet> Congress should give the NRC legislative authority over
technically enhanced naturally occurring radioactive material.
Currently, Federal guidance is limited to naturally occurring
radioactive material, which is not scientifically consistent when the
material is concentrated.
Many of the above proposals were included in S. 1627 as passed by
the Senate in the 106th Session of Congress. NEI thanks this
subcommittee and the full Environment and Public Works Committee for
its work on these issues.
NEI has reviewed the legislative proposals that the NRC forwarded
to Congress in a letter dated February 28, 2001. The nuclear industry
commends the NRC for those initiatives and urges this subcommittee to
support such legislation.
summary of key points
<bullet> Initial implementation of the NRC's new reactor oversight
process has gone smoothly. This process must continue, and the
underlying principles must be expanded to the remainder of the NRC's
regulatory process. I urge the committee to support safety-focused
regulatory processes. In addition, the committee should examine how
these changes, as well as the increased needs for possible new plant
licensing, will impact NRC staffing levels.
<bullet> The next step in regulatory reform is to revise the
regulations to incorporate risk insights and performance-based
approaches consistent with those used in the reactor oversight process.
This committee should continue its careful oversight of the NRC and
request regular reports from the agency detailing the progress it is
making on codifying the new regulatory process.
<bullet> The Federal Government must establish science-based,
uniform standards for radiation protection, under the oversight of a
single Federal agency. It is clear that legislation will be needed, and
the industry asks this committee to ensure that this action is taken.
<bullet> The Price-Anderson Act must be renewed this year. The act
provides the legal framework for nuclear facility insurance coverage,
which for commercial facilities is funded by the industry. The Price-
Anderson Act is a necessary element in assuring the public that the
industry is prepared for contingencies.
<bullet> Many changes have taken place since the last major
revision to the Atomic Energy Act, the fundamental legislation that
established our nation's nuclear programs. Several revisions are needed
to remove unnecessary impediments for nuclear power plants as they
transition to a competitive marketplace. The industry urges the
committee to support legislative action to amend the act.
conclusion
Nuclear energy is the only large source of electricity that is both
emission free and readily expandable. Its safety record, reliability,
cost effectiveness and price stability make nuclear energy a vital fuel
for the future. That is clear from the current U.S. energy situation,
which is marked by thinning capacity margins and volatile prices for
fossil fuels.
In the future, as electricity demand continues to rise, nuclear
energy will be even more important to American consumers--and to our
nation's economy as a whole. Our nation's nuclear power industry has
proven over the past two decades that nuclear energy is a reliable,
efficient, and safe source of electricity for our nation's economic
growth. I urge the members of this committee to support the role of
nuclear energy in the U.S. energy mix.
Thank you for giving me this opportunity to share the industry's
perspective on oversight of nuclear facilities and several related
matters.
______
Responses by Joe F. Colvin to Additional Questions from Senator Reid
Question 1. How many nuclear power plants have significant foreign
ownership?
Response. Federal law, Section 103d of the Atomic Energy Act,
currently precludes foreign corporations, or one if its subsidiaries,
from owning a controlling interest in a commercial nuclear power plants
in the United States or a NRC licensee that operates a plant. As such,
there is no significant foreign ownership of U.S. nuclear power plants.
Of the 103 operating nuclear units in the United States, only three
are owned, in part, by a foreign company. Those plants include Three
Mile Island Unit 1, Clinton and Oyster Creek. All three plants were
purchased in 1999 and 2000 by AmerGen Energy Co., a 50/50 joint venture
between PECO Energy (which merged last year with Unicom to form
Exelon), and British Energy, of Edinburgh, Scotland.
NEI and the NRC have urged Congress to eliminate the blanket
restriction in Section 103d. The NRC would still retain the authority
to ensure that any licensing action it takes is consistent with pubic
health and safety requirements and is not inimical to national defense
and security. Other Federal laws that also apply to American businesses
in general, including commercial nuclear power plants, prohibit foreign
ownership of American corporations if such ownership is inimical to our
national security interests.
A restriction on foreign ownership of commercial nuclear power
plants is an unnecessary barrier to an important source of capital.
Competing producers of electricity in the United States, such as wind,
solar, biomass, coal and gas plants, are not burdened with a blanket
restriction such as Section 103d. Foreign ownership of a commercial
nuclear power plant does not per se impose a threat to our national
security interests.
Question 2. How many of the principal nuclear power engineering,
maintenance and equipment supply companies have significant foreign
ownership?
Response. Federal law, Section 103d of the Atomic Energy Act, that
restricts the foreign ownership of commercial nuclear power plants in
the United States, does not similarly restrict the foreign ownership of
other nuclear power-related businesses. The nuclear energy industry is
a worldwide enterprise. Non-U.S. companies have a growing presence in
the U.S. market, which reflects their conviction that the United States
represents an attractive business opportunity. U.S. companies have
significant financial interests in overseas markets.
Subsidiaries of British and French companies have the largest
presence in the United States. BNPLs Inc., a wholly-owned subsidiary of
British Nuclear Fuels, Ltd., has acquired the nuclear design/
engineering assets of Westinghouse and ABB-Combustion Engineering.
France's Framatome owns the nuclear business formerly owned by Babcock
& Wilcox. In addition, France's Cogema and Urenco, the Anglo-German-
Dutch company, have a significant presence in the U.S. nuclear fuel
market.
These acquisitions of domestic nuclear assets by foreign
corporations were fully reviewed by the Committee on Foreign Investment
in the United States, an interagency committee chaired by the
Department of the Treasury that was created pursuant to the 1988 Exon-
Florio amendment to the Defense Production Act of 1950. Under that law,
the President of the United States can prohibit the foreign acquisition
of any domestic corporation if it found that such action would pose a
threat to our national security. Additional information regarding the
CFIUS can be found at www.treas.gov/oii.
Similarly, U.S. companies are active overseas. General Electric is
building advanced light water reactors in Japan and Taiwan. ABB-
Combustion Engineering is active in South Korea. USEC, Inc., the U.S.
uranium enrichment company, is the world's largest supplier of uranium
enrichment services, and has a 30-40 percent share of the non-U.S.
market for enrichment services.
Question 3. The Administration has discussed reducing our
dependence on foreign energy supplies. How do we accomplish that if our
nuclear power industry is gaining increasing foreign investment in both
the generation, and maintenance and supply aspects of the industry?
Response. As noted above, the nuclear energy business--like
petroleum, automobile manufacturing, information technology, banking
and virtually every other commercial enterprise of note--is an
international endeavor. U.S. energy companies have significant
investments outside the United States. Foreign companies--largely from
Britain and France, our longtime allies--have significant investments
in the U.S. electric power business generally, and the nuclear energy
sector specifically through U.S. chartered affiliates. Operations and
production in all countries with nuclear electricity have benefited
from the resultant sharing of best practices and capabilities to
improve safety and efficiency around the world.
Domestic concerns with energy security and foreign energy
dependence, either currently or historically, have not occurred due to
foreign ownership of energy facilities by companies from trading-
partner countries. Rather, energy security concerns arise when nations
experiencing political instability are the source of necessary fuels
that cannot be domestically supplied or sufficiently stockpiled so as
to manage risks and costs from fluctuating supplies and prices. The
only fuel for which this issue arises is oil.
The nuclear industry was developed to mitigate impacts to the
environment in electricity production while acting as a risk management
tool or hedging mechanism against such foreign oil supply and price
problems. Nuclear fuel is safely stockpiled; the primary source
countries for mined uranium are stable American allies and trading
partners, and small fuel volumes can provide high volume, long-term
electricity supply, making nuclear electricity a key underpinning of
U.S. energy security.
U.S. energy security and U.S. vulnerability to foreign manipulation
would be seriously compromised in the absence of nuclear energy. Its
success in meeting energy security goals is borne out by the numbers--
in 1973, at the time of the first oil embargo, oil provided
approximately 20 percent of U.S. electricity supply; nuclear energy,
only about 4 percent. By contrast, nuclear energy today represents
approximately 20 percent of U.S. electricity supply; oil, only about 3
percent. Nuclear energy has thus displaced large amounts of oil (and
other fossil fuels) that would otherwise have been required for
electricity generation.
Nuclear fuel is also produced from source material redirected away
from weapons use into peaceful energy production. This reuse reduces
the risk of proliferation at the same time it produces electricity
without harmful air pollutants or greenhouse gases--essentially turning
``megatons'' of destructive weaponry to ``negatons'' (no tons of
potentially harmful emissions). The international cooperation and
interaction reflected in these programs has been a hallmark of the
nuclear industry since President Eisenhower first set the course for
peaceful uses of this technology. And, by displacing the use of fossil
fuels to preserve limited supplies, uranium fueled electricity also
contributes to sustainable development. Fortunately, there is no
indication that foreign ownership of nuclear international nuclear
companies would do anything to change or impair the continued
successful delivery of these energy, security, and environmental
services.
Question 4. Significant research has gone into developing reactors
with improved safety performance. How much research has the industry
put into developing plants that have improved performance with regard
to waste?
Response. Nuclear power's recognized improvement in waste
elimination and management over existing electricity production methods
was a primary reason for commercial nuclear electricity development as
early as the 1950's and 60's. Since its inception, commercial nuclear
electricity production has lead all industry in preventing, minimizing,
and managing waste byproduct creation and introduction into the
environment. Toxic air and water pollutants, the common waste materials
generally created by electricity production, are avoided almost
entirely in fission electricity. Heat waste is minimized and treated
before release into water bodies or air. Fuel storage, either before or
after use, does not require large areas for storage, or create leachate
or other potentially harmful discharges. Because fission requires no
end-of-the-pipe remediation for its air emissions, no secondary waste
such as scrubber sludge is created, requiring disposal.
Approximately 40,000 tons of used nuclear fuel remains available as
a secondary raw material for reuse and recycling to support future
sustainable development, should it be needed as originally anticipated
by the Federal government. Hazardous radioactive constituents naturally
attenuate (degrade) without causing adverse environmental impacts, as
fuel is safely stored in on-site facilities and ultimately, in a
geologic depository. Building on this past success in used fuel and
waste management, the U.S. nuclear industry continues to achieve
significant progress in minimizing volumes of used fuel created, as
well as low-level nuclear waste that is treated and disposed at time of
use.
Used Nuclear Fuel.--The industry has consistently supported
research efforts to develop advanced nuclear plant designs that combine
improved safety performance as well as improvements in high- and low-
level nuclear waste management. In 1999, the Department of Energy (DOE)
created the Nuclear Energy Research Initiative (NERI), a research and
development program that seeks to remove barriers to the future use of
nuclear energy. In addition to providing grants for development of
advanced nuclear plants that are safer, more economic and more
efficient, one of NERI's goals is to develop technology that will
improve management of used nuclear fuel.
The industry's most significant success in minimizing volumes of
used fuel produced has nothing to do with research programs, however.
The most notable success is operational. During the 1990s, U.S. nuclear
generating capacity actually declined by approximately 1,000 megawatts,
yet production increased by 177 billion kilowatt-hours. This increase
is approximately equal to the output from 22 new 1,000-megawatt power
plants operating at a 90-percent capacity factor, and satisfied over 20
percent of the increase in U.S. electricity demand during the 1990s.
This increase in productivity was achieved by operating more
efficiently and reliably, obtaining more electricity from the same
volume of fuel, without increasing the volume of used fuel produced.
The volume of used fuel produced remained virtually constant through
the 1990s (at approximately 3,000 metric tons per year) but the amount
of electricity derived from the fuel increased by 23 percent.
Low-Level Waste.--Similarly, the volumes of low-level waste (LLW)
produced by the commercial nuclear energy industry have declined
dramatically. The LLW volumes produced by boiling water reactors have
declined by 92 percent since 1980; the volumes produced by pressurized
water reactors have declined by 96 percent during the same period.
Question 5. As you know, the construction of new nuclear plants
will likely compete with natural gas turbine plants. How high does the
cost of natural gas have to go to make building a nuclear power plant
substantially more attractive to overcome the public mistrust of the
industry and the extremely high capital and operating costs of nuclear
power plants?
Response. Unfortunately, all forms of large capital projects are
experiencing the effects of ``nimbyism,'' which in turn can cause
troubling effects for energy supply in the future. The challenge to all
energy producers (including gas plants, which are failing to gain
community approval around the country) is to site plants using our
diverse menu of fuels so as to maximize the benefits to the
communities, the economy, and the environment.
In order to make electricity in an environmentally preferable
manner, all plants are being built to meet stringent environmental
standards, especially with regard to air pollution and greenhouse
gases. Fortunately, the cost of a nuclear plant includes the capital
investment needed to eliminate potentially harmful air emissions-
something no other baseload form of generation can do except for
hydroelectric. Without a significant percentage of the electricity
supply remaining emission-free (today its over 30 percent), it will be
difficult, if not impossible, to build the new plants needed and remain
within Clean Air Act standards.
Not only do nuclear plants have affordable capital and operating
costs, investment in nuclear includes the avoided costs of many
potential health and environmental impacts. In a recent letter to the
Administrator of the U.S. EPA, Senators Jeffords and Lieberman both
indicated that ``the health and environmental benefits associated with
emission reductions'' were not adequately reflected in government
analyses of the costs and benefits of controlling air pollutants.
Omitting these benefits from calculations of the costs of nuclear
plants creates the same cost distortions that the Chairman and
Subcommittee Chairman point to, especially since nuclear plants use the
best emission control technology available avoid making them in the
first place.
The U.S. nuclear energy industry estimates that new nuclear power
plants could be built in the United States for between $1,000 and
$1,200 per kilowatt of capacity. The industry has a high level of
confidence in these cost estimates for several reasons:
1. The cost estimates are for advanced light water reactor designs
in which the industry and the Federal Government invested several
hundred million dollars during the 1990s.
2. Thanks to this investment, these designs are essentially fully
engineered.
3. Because so much of the engineering and design work is complete,
it is possible to develop relatively precise cost estimates.
At this capital cost of $1,000-151,200 per kilowatt of capacity,
new nuclear power units are fully competitive with the other
alternatives for baseload electricity production, before the emission
control benefits are accounted for.
The alternatives to new nuclear plants include:
1. Conventional coal-fired power plants with a full suite of
environmental controls. Largely because of the significant increase in
the cost of natural gas, which has increased the cost of electricity
from gas-fired power plants, a growing number of new coal-fired
projects are being proposed. These conventional coal-fired plants
typically have capital costs in the range of $1,000-1,100 per kilowatt
of capacity.
2. The so-called ``clean coal'' technologies, which have capital
costs in the range of $1,200-1,500 per kilowatt of capacity. For
example, Reliant Energy is building a 520-megawatt plant in
Pennsylvania using a clean coal technology called atmospheric fluidized
bed combustion. This project has a total capital cost of $800 million,
for an overnight capital cost of approximately $1,500 per kilowatt of
capacity. Over time, as more of these atmospheric fluidized bed plants
are built, the technology developers expect to be able to reduce the
capital cost. Their current target $1,000-1,200 per kilowatt.
Other ``clean coal'' technologies have higher capital costs than
atmospheric fluidized bed combustion. An integrated gasification
combined cycle (IGCC) plant currently has a capital cost of
approximately $1,800 per kilowatt for the first plants built, according
to estimates from the technology developers and data from the
Department of Energy's clean coal technology program. The technology
developers hope to reduce this capital cost to $1,200-1,500 as the
technology matures and more of these plants are built. However, to
attain any future emission limits (such as a ``net'' emission
requirement for greenhouse gases, additional costs would be incurred
that are already built into the price of a nuclear plant).
3. New combined-cycle gas-fired power plants, which have capital
costs in the range of $600-700 per kilowatt of capacity. The total cost
of these plants generally changes when the full suite of environmental
controls required for impending emission limits is added. In many
cases, control technologies like selective catalytic reduction (SCR)
are difficult to obtain due to limited production, and can add cost or
lower efficiencies when in operation. Often, capital costs must include
additional pipeline and transmission feeders.
Unlike the nuclear and coal-fired technologies, gas-fired power
plants are extremely sensitive to fuel prices. Economic analysis shows
that a new nuclear unit at $1,000 per kilowatt of capacity is
competitive with a new gas-fired combined cycle plant at a capital cost
of $600 per kilowatt of capacity fueled with gas at $4-5 per million
Btu. (Although wellhead gas prices in the spot market have slumped
below $4 per million Btu in recent weeks, the cost of gas delivered to
electricity generators remains well above $5 per million Btu in all
major consuming regions of the United States except California. In
California, delivered prices for natural gas are considerably higher,
in the $10-15 per million Btu range.)
Public Attitudes to Nuclear Energy.--There is also increasing
public support for continued operation of existing nuclear plants as
well as for construction of new nuclear plants as concern about
electricity shortages and prices spread across the nation. In recent
polls of public opinion, 66 percent of adults in all regions of the
country support building more nuclear power plants, compared to 42
percent in October 1999. The March 2001 survey also found increased
support for renewing the licenses of nuclear plants. Eighty-seven
percent agreed licenses should be renewed, up from 79 percent in
October 1999.
Operating Costs.--Nuclear power plants are among the lowest-cost,
economical sources of electricity in the nation. As a result of
improved productivity and reliability over the past 10 years, U.S.
nuclear plants are fully competitive in the deregulated, competitive
electricity markets now evolving across the United States. On average,
a nuclear power plant produces electricity at a total cost of
approximately 2.0 cents per kilowatt-hour. This is comparable with
large coal-fired power plants, and much less costly than electricity
produced by power plants fueled by natural gas.
Question 6. Paul Joskow, an MIT economist, recently said referring
to the price per unit capacity: ``None of these deals even comes close
to covering the book costs. You couldn't justify paying $2,000 or
$3,000 per kilowatt for those plants.'' He added that investors would
have to expect a huge competitive benefit from nuclear plants to risk
putting money in a new one ``because of the significant possibility of
coming up with a dry hole.'' Do you agree with this assessment?
Response. We view the current situation for existing plant
transactions and new construction differently from Mr. Joskow, and will
separately address these two components in the question.
The first involves existing nuclear plants. The reference to ``book
costs'' of ``$2,000 to $3,000 per kilowatt'' involves recent
transactions involving the sale of existing nuclear units. In contrast
to the units built in the 1960's and 70's (several of which are still
operating) many nuclear units commissioned during the 1980s cost
significantly more than expected. This was caused by the harsh economic
and regulatory environment in which they were built. Plants under
construction during the 1980s were engulfed in new design and operating
requirements imposed by the Nuclear Regulatory Commission after the
Three Mile Island accident. These changes often forced significant
redesign and rework during construction, which resulted in schedule
delays. At the same time, the United States was experiencing double-
digit inflation and extremely high interest rates, which drove up the
cost of all capital-intensive projects in all industries.
In states that have not restructured their electric power
industries, this investment is being recovered over time from
electricity consumers. In states that have restructured, the
unrecovered original investment (often called a stranded cost) is
typically recovered through some form of competitive transition charge.
As a result, there was no need or incentive to recover the unamortized
book value of a nuclear unit when it was sold as a result of a State
restructuring initiative.
The second part of Mr. Joskow's comment involves construction of
new nuclear power plants, which is covered, in part, in the answer to
the previous question.
Private companies will invest in new nuclear power plants only if
they are convinced that new nuclear plants are a sound business
opportunity that, once built, will be competitive with other sources of
electricity. Given the significant benefits of nuclear energy, the
Federal Government should consider limited policy initiatives to
stimulate companies to invest in new nuclear plants sooner and in
larger numbers than they otherwise would. The policy initiatives
necessary to stimulate construction of new nuclear generating capacity
include:
1. Changes to the tax laws to reduce the investment risk associated
with new nuclear plant construction and to allow quicker recovery of
capital investment, including such techniques as accelerated
depreciation, an investment tax credit and, possibly, access to State
tax-exempt bond financing.
2. Creation of a government/industry partnership to pursue two
short-term objectives: resolving technical and/or economic issues
associated with the new nuclear plant designs, and validating the new
licensing process--verifying that it works as intended and will not
place private sector investment at risk. This initiative will require a
modest additional Federal investment in nuclear energy research and
development.
3. Amendments to update the Atomic Energy Act so that the NRC is
positioned to meet the challenges of the 21st century. This includes
removing the statutory requirement that NRC conduct antitrust reviews
of applications to build new nuclear plants; removing the statutory
prohibition on foreign ownership of U.S. commercial nuclear power
plants; and revisions to ensure that small, modular nuclear reactors
and large reactors are subject to comparable liability under the Price-
Anderson Act's secondary protection scheme.
4. Renewal of the Price-Anderson Act.
Question 7. The industry now claims to be operating at much higher
efficiency levels. Aren't these levels what the industry promised they
would be able to offer, but failed to meet in the past? What were the
major causes of the past efficiency problems? Can we expect this
performance trend to continue as the plants age or are relicensed, or
will we see a return to the low efficiency levels that plagued the
industry?
In 2000, the industry average capacity factor was nearly 90
percent, a record high. The electricity output from U.S. nuclear power
plants increased by approximately 23 percent during the 1990s--
equivalent to the output from 22 new 1,000 megawatt plants. This
improved performance resulted from a combination of a number of
different factors, including reduction in outage duration, personnel
training and experience, sharing and applying plant operating
experience, and application of new technology. In effect, the industry
has progressed through a natural learning curve to this record level of
performance.
The industry expects the improving performance trend to continue,
although it will eventually reach an upper limit, expected to be an
industrywide average capacity factor approximately 92-95 percent. This
is due to the fact that refueling the reactors requires outages, and
those periods are nearing optimum achievable duration. The industry
does not expect an adverse impact on capacity factors as plants age
because many of the key components are replaced or refurbished on a
regular basis as part of predictive and preventive maintenance
programs.
Question 8. How much additional power could be generated from
today's nuclear power plants through efficiency improvement? Does the
NRC's relicensing process encourage such steps? How? If not, why not?
Response. The industry estimates that the equivalent of
approximately 10,000 megawatts of capacity can be gained from the 103
nuclear units now operating through (1) further improvement in capacity
factors, and (2) power uprates to existing plants.
NEI believes that there is potential for additional efficiency from
plant designs. An important program in this area is the Nuclear Energy
Optimization Program (NEPO), a research and development program
administered by the Department of Energy. NEPO is a cost-shared
program, jointly funded by Congress and the nation's nuclear utilities,
to address high-priority technical issues and opportunities facing
today's currently operating nuclear energy plants. These issues include
opportunities for reliability and efficiency improvements through power
uprates, longer fuel cycles and greater reliance on digital
technologies.
NEPO was first proposed by the Department of Energy for FY 2000 and
received $5 million from Congress. This year, the Bush Administration
has recommended that NEPO once again receive $5 million.
NEI welcomes and commends Congress and the Administration for their
support for this program. As was noted by William D. Magwood IV, the
Director of the Office of Nuclear Energy, Science and Technology at the
Department of Energy, ``by 1998, all of [our Nation's] nuclear energy
research and development programs had been terminated and policies were
enacted that discouraged the use of nuclear energy or placed it at a
competitive disadvantage.'' With the funding of NEPO and other nuclear
research initiatives, Congress is once again beginning to recognize the
importance of investing in nuclear research.
The NRC's license renewal process focuses solely on the safety
aspects of the extended term of operation. To encourage improvements in
efficiency is beyond the Commission's charter. The agency does review
power uprate requests, and the Commission has recently directed the NRC
staff to give high priority to the review of such requests in light of
potential electricity shortages affecting different areas of the
country.
______
Nuclear Regulatory Commission, Washington, DC
Memorandum to: LChairman Meserve, Commissioner Dicus, Commissioner
Diaz, Commissioner McGaffigan, Commissioner Merrifield
From: LJ. Hopenfeld, Engineering Research Application Branch, Division
of Engineering Technology, Office of Nuclear Regulatory Research
Subject: LDiffering Professional Opinion On Steam Generator Tube
Integrity Issues
It is now almost 10 years since I originally raised several serious
safety issues concerning the NRC practice of permitting excessively
degraded steam generators tubes to remain in service during plant
operations. This practice while benefiting the nuclear industry, has
had a serious negative potential impact on public safety. After many
and continuing attempts by NRC management to ignore these DPO issues,
they remain unresolved. As demonstrated by the Indian Point 2 (IP2)
accident, excessively degraded tubes continue to threaten public
safety.
Blatantly disregarding the recent ACRS findings (items 1-9 below)
the staff granted South Texas 2 relief on March 8, 2001.
This memo is to request that you take the appropriate actions and
instruct PWR plants to plug all tubes that exceeded 2 volts at the
beginning of the last fuel cycle. These plants are in violation of 10
CFR PART 100 and present an unacceptable safety risk. Further
regulatory relief under GL95-05 should be suspended until all the ACRS
safety concerns are addressed.
During the past 10 years, the NRC has expended inordinate resources
on my DPO safety issues and has publicly claimed that they have been
properly addressed. The new ACRS findings, NUREG-1750, clearly indicate
that the staff contentions were flawed and misleading, and that the
allocated resources have been wasted.
The ACRS had concluded last November that the staff position on the
issues raised by the DPO is indefensible. Accordingly, the Executive
Director for Operations, EDO, was requested to resolve these issues and
report the outcome to the ACRS. Instead, the EDO merely instructed the
divisions of RES and NRR to draft a new action plan and closed the DPO.
Closing the DPO without specifying how it will be resolved is a clear
violation of Management Directive (MD) 10.159(C). The EDO's latest
action compounds previous violations of MD 10.159, making a sham of the
entire process of encouraging employees to raise safety concerns. The
NTEU union filed a grievance on my behalf to keep the DPO open until it
is resolved.
The EDO has already tried before, and failed to cause the staff to
address adequately the DPO issues. In a memo to me dated May 1, 1996,
the EDO stated that, ``the staff would undertake `a vigorous research'
program to investigate steam generator material behavior, adequacy of
crack detection and analysis methods, behavior of steam generators
under selected severe accidents scenarios, and improved understanding
of iodine spiking in regard to radiological consequence, as recommended
by the ACRS regard to your DPO.''
Ten years of ``vigorous research'' clearly did not produce results
that can be used to grant regulatory reliefs. These results only
reflect technical ignorance and incompetence. Nevertheless, the EDO now
plans to invest additional funds on ``research''. This practice of
spending money on research for the ostensible purpose of masking
regulatory inaction should be stopped.
The transcripts from the ACRS hearings and the following quotations
from NUREG-1750 clearly demonstrate the poor state of knowledge at the
NRC regarding steam generator safety issues.
1. ``The staff has not adopted a technically defensible position on
the choice of iodine spiking factor to be used on the analysis of
design for compliance with requirements of 10 CFR Part 100 or General
Design Criteria 19.''
2. ``The staff need to develop a defensible analysis of the
uncertainties in its risk assessment, including uncertainties in its
assessments of human error probabilities'' (during design basis
accidents.)
3. ``The staff has not developed persuasive arguments to show that
steam generator tubes will remain intact under the conditions of risk-
important accidents which the reactor coolant remain pressurized.''
4. ``The Ad-Hoc Subcommittee found that the staff did not have a
technically defensible understanding of these processes to assess
adequately the potential for progression of damage of steam generator
tubes.''
5. ``The Ad-Hoc Subcommittee did not feel that the staff has
developed an adequate understanding of how movements of the tube
support plate during an event could damage the tubes.''
6. ``The Subcommittee did not attempt to reach conclusions
concerning occasions when staff granted exemptions to these criteria (1
& 2 V) except to note that these exemptions should have been
accompanied by more complete risk analysis.''
7. ``The databases for \7/8\'' tubes need to be greatly improved to
be useful.''
8. ``This issue (tube shearing during depressurization), at the
current level of understanding cannot be used to judge the adequacy of
the alternative repair criteria described in GL-9545.''
9. ``The issue of the possible evolution of severe accidents to
involve gross failure of steam generator tubes and bypass of the
containment is not yet resolved.''
The EDO's memorandum to me dated March 5, 2001, misrepresented the
ACRS findings by stating that the ACRS ``found that no immediate
regulatory actions are necessary.'' There is no reference in the ACRS
report (NUREG-1750) to such findings. It is difficult to comprehend how
anyone, even with minimal engineering background and knowledge of
reactor operation, could conclude that the ACRS concerns do not raise
serious safety issues that require immediate actions. Nevertheless, the
EDO decided that these concerns can be resolved with additional
research.
I disagree with the ACRS, to a degree, that the staff showed an
inadequate understanding of the DPO issues. The staff has no
understanding in certain major issues of the DPO. Given an environment
where technical peer reviews do not exist, where staff with inadequate
training is assigned to unfamiliar tasks, and where research results
are preselected by management, it would be surprising if the staff had
found an adequate resolution of the safety issues.
If the EDO believes that all that is required to resolve the ACRS
concerns is additional research he is poorly informed concerning of how
research is conducted at the NRC. In 1990, a prominent scientist, Dr.
Novak Zuber told the American Nuclear Society at an award ceremony
(Inside NRC, Nov 19, 1990) that the NRC conducts research in a manner
which completely precludes the resolution of safety issues. What he
said then is equally true today, ``This (NRC) method of resolving the
issue claims victory by waving arms, by twisting arms. However there is
no resolution of the technical issues, and the problem is not solved,
this problem will come up again next year . . . because it is not
solved.''
Technical solutions which are not favorable to the industry are set
aside and are declared by management as ``solved''. Because the
management is unwilling to confront the nuclear industry, staffers are
afraid to express their concerns and must communicate by whispers in
fear that they will be marked as ``enemies'' and their careers
destroyed.
Last November the South Texas Project informed the staff that they
would suffer a substantial financial loss if they had to plug tubes in
South Texas Unit 2 beyond the 2V limit. Even though the ACRS concluded
that leaving tubes beyond the 2V limit may not be conservative and
South Texas did not properly address support plate movement and
vibrations during depressurization, the staff quickly granted the
licensees request.
The disregard of the ACRS findings and the approval of the South
Texas Unit 2 request sends a clear signal to the nuclear industry:
under the guise of ``risk informed regulations'', there is no need to
have a valid and defensible technical position because regulatory
relief is always granted when requested. Any rationale, even if it
violates the basic laws of physics, can serve as a justification for
requesting relief. Financial impact of the relief takes precedence over
public safety.
Steam generators were originally sold to the utilities with the
understanding that they would operate acceptably within design
parameters for the lifetime of the plant. Because of inadequate and
improper material selection, this expectation has never been fulfilled
and some steam generators have been replaced after only a few years of
service. U.S. plants alone have experienced 11 steam generator tube
failure accidents, which can be traced to poor design and lack of
meaningful NRC oversight. Additional, and possibly catastrophic, steam
generator tube failure accidents can be expected in the future since
many nuclear power plants will be re-licensed for another 20 years.
The nuclear industry, however, has done essentially nothing to
seriously address the safety issue. Licensees have demonstrated that
their main goal is to continue using severely degraded steam generators
as long as they want to do so. The NRC has been unwilling to insist
that safety take priority over economics.
My DPO defined the main safety issues that should be addressed
before relaxing the existing rules, for utilizing steam generators to
the maximum extent possible without endangering the pubic. While the
DPO failed to attain this goal, for 10 years it has kept the public
informed of the identified technical problems with severely degraded
steam generator tubes. On at least one occasion, against NRC wishes,
the DPO with public help, was instrumental in preventing severely
degraded steam generators from being returned to service.
The NRC practices regarding steam generators contributed
significantly to the recent IP2 accident. Fortunately this accident did
not have significant safety consequences, it was, however, a serious
precursor to the type of accidents which are described by the DPO. The
NRC takes the unacceptable position that if the DPO accidents have not
occurred they will not occur in the future.
The DPO has served as a reminder to the NRC that it can be held
accountable for catastrophes that may follow steam generator tube
failures. To remove this constant reminder, the NRC has used various
methods in disregard of its own regulations: personal retaliations,
attempts to select an unqualified DPO review panel, arm twisting
(causing the resignation of one member from that panel), and a refusal
to appoint an unbiased outside panel.
Though the ACRS findings apparently were not expected and could not
be ignored, no efforts are being spared to minimize and obscure the
findings. Regrettably, this continues the NRC culture of failing to
keep the public informed of the danger to them from not removing
severely degraded steam generators from service.
__________
Statement of David Lochbaum, Nuclear Safety Engineer, Union of
Concerned Scientists
My name is David Lochbaum. I have been the nuclear safety engineer
for the Union of Concerned Scientists (UCS) since October 1996. Prior
to joining UCS, I spent more than 17 years in the industry on the
startup and operation of nuclear power plants. UCS, established in
1969, seeks to ensure that all people have clean air, energy and
transportation, as well as food that is produced in a safe and
sustainable manner. We have worked on nuclear plant safety issues for
nearly 30 years. In fact, far too many of the safety issues that I work
on today were also worked on by my predecessor, Robert Pollard, and his
predecessors, Daniel Ford and Henry Kendall. This experience convinces
us that the United States should not consider an expanded role for
nuclear power until we achieve something that we have never had--
namely, a consistently effective regulator.
The Nuclear Regulatory Commission (NRC) has exclusive
responsibility for regulating safety at U.S. nuclear power plants. That
the last U.S. reactor meltdown happened 22 years ago (Three Mile
Island) is circumstantial evidence that the NRC is not always an inept
regulator. On the other hand, there is mounting circumstantial evidence
in areas such as nuclear plant license renewal, steam generator tube
cracking, risk-informed regulation, and nuclear plant security
indicating that the NRC is not always an effective regulator either.
These warning signs are described in the following sections.
nuclear plant license renewal
The NRC currently approves a 20-year extension to the original 40-
year license for a nuclear plant after its owner ``demonstrates that a
nuclear power plant facility's structures and components requiring
aging management review in accordance with Sec. 54.21(a) for license
renewal have been identified and that the effects of aging on the
functionality of such structures and components will be managed to
maintain the CLB [current licensing bases] such that there is an
acceptable level of safety during the period of extended operation.''
\1\ In theory, this demonstration seems like a solid basis for
continued safe operation. In reality, this demonstration amounts to
little more than a paperwork exercise that is frequently contradicted
by actual experience. Since the beginning of the 21st century, at least
eight nuclear power plants have been forced to shut down due to
equipment failures caused by aging:
---------------------------------------------------------------------------
\1\ Part 54, Requirements for Renewal of Operating Licenses for
Nuclear Power Plants, of Title 10 of the Code of Federal Regulations.
---------------------------------------------------------------------------
1. March 7, 2000: The owner reported that Nine Mile Point Unit 2 in
New York had automatically shut down when the system controlling the
level of water over the reactor core failed. The owner attributed the
failure as ``Specifically, the manual-tracking card failed to provide
an output signal when the feedwater master controller was switched from
automatic to manual mode of operation The manual-tracking card failed
due to aging.'' [emphasis added]
2. March 14, 2000: The owner reported that Catawba Unit 1 in South
Carolina had automatically shut down due to an inadvertent electrical
ground problem. The owner reported ``A detailed failure analysis
determined that the root cause of the connector failure was the
misapplication of the connector insert insulating material which is
made of neoprene. . . . The neoprene insert at the failure point on the
connector exhibits signs of accelerated aging [emphasis added]. The
inserts are hardened and there are charred deposits on the end of the
inserts which are indications of electrical tracking.''
3. March 17, 2000: The owner reported that Indian Point Unit 2 in
New York had been forced to declare an emergency condition and shut
down after a steam generator tube failed and resulted in approximately
19,197 gallons leaking from the reactor coolant system. The owner
stated ``Preliminary analysis indicates that the cause of the tube
failure is primary water stress corrosion cracking (PWSCC)'' [i.e.,
aging].
4. March 27, 2000: The owner reported that Catawba Unit 2 in South
Carolina had automatically shut down due to an inadvertent electrical
ground problem. The owner reported ``A detailed failure analysis
determined that the root cause of the connector failure was the
misapplication of the connector insert insulating material which is
made of neoprene. . . . The neoprene insert at the failure point on the
connector exhibits signs of accelerated aging [emphasis added]. The
inserts are hardened and there are charred deposits on the end of the
inserts which are indications of electrical tracking.''
5. September 12, 2000: The owner reported that Oyster Creek in New
Jersey had been forced to shut down because a system needed to provide
containment integrity had failed a periodic test. The owner determined
``The cause of the degradation in Secondary Containment was age-related
degradation [emphasis added] of the automatic ventilation exhaust valve
seals.''
6. September 27, 2000: The NRC reported that Diablo Canyon Unit 1
in California had automatically shut down after an electrical
transformer failed and interrupted the supply of electricity to the
reactor coolant pumps. The NRC stated ``The licensee's evaluation
concluded that a center bus bar overheated at a splice joint, which
caused a polyvinyl chloride boot insulator over the splice joint to
smoke. Eventually, heat-induced failure of fiberglass insulation on
adjacent phases resulted in phase-to-phase arcing'' [i.e., aging].
7. February 16, 2001: The owner reported that North Anna Unit 2 in
Virginia had been forced to shut down due to leakage exceeding 10
gallons per minute from the reactor coolant system. The owner
determined ``The cause of the stem packing material failure below the
lantern ring is attributed to aging'' [emphasis added].
8. April 2, 2001: The owner reported that San Onofre Unit 3 in
California automatically shut down after an electrical breaker failed
and started a fire. The failed breaker was reportedly 25 years old and
scheduled for inspection next year. The owner ``will implement
modifications to appropriate preventative maintenance [emphasis added]
procedures to address the apparent failure causes.''
Aging management programs are intended to monitor the condition of
equipment and structures and implement repairs or replacements when
necessary to prevent failures. The cited aging-related failures,
occurring about once every 60 days, indicate beyond reasonable doubt
that the aging management programs are inadequate because they are not
preventing equipment failures. The NRC must ascertain the effectiveness
of aging management programs--not merely the scope of these programs--
before granting license extensions.
steam generator tube cracking
Dr. Joram Hopenfeld, who recently retired from the NRC staff,
raised concerns about the integrity of steam generator tubes to his
management nearly 10 year ago. The agency--which steadfastly claims
that safety is its top priority--essentially ignored them until an
accident last year at Indian Point 2. The ensuing public outcry and
congressional attention resulting from that accident, which was
initiated when a cracked steam generator tube failed, forced the NRC to
dust off Hopenfeld's concerns and finally look into them. The NRC asked
its ACRS to evaluate the decade-old concerns.
The NRC's Advisory Committee on Reactor Safeguards (ACRS) issued a
report in February 2001.\2\ The ACRS substantiated many of Dr.
Hopenfeld's concerns. For example, the ACRS concluded:
---------------------------------------------------------------------------
\2\Advisory Committee on Reactor Safeguards, Nuclear Regulatory
Commission, ``Voltage-Based Alternative Repair Criteria,'' NUREG-1740
(Washington, DC: February 2001).
<bullet> ``The techniques [used to look for cracked steam
generator tubes] are not nearly so reliable for determining the
depth of a crack, and in particular, whether a crack penetrates
through 40 percent of the tube wall thickness.'' [NRC's
regulations do not allow a nuclear plant to startup with any
steam generator tube cracked more than 40 percent of its wall
thickness, but the methods used to inspect the tubes for cracks
cannot reliably determine the depth of cracks.]
<bullet> ``The NRC staff acknowledged that there would be
some possibility that cracks of objectionable depth might be
overlooked and left in the steam generator for an additional
operating cycle.'' [Exactly what actually happened at Indian
Point 2 to cause last year's accident.]
<bullet> ``Both the [NRC] staff and the author of the DPO
[Dr. Hopenfeld] agree that the alternative repair criteria
[used by the NRC staff to allow nuclear plants to continue
operating with steam generator tubes known to be cracked]
increase the probability of larger primary-to-secondary flows
during the MSLB [main steam line break] and SGTR [steam
generator tube rupture] accidents.''
<bullet> ``The [ACRS] also finds that this contention of the
DPO [namely, that an accident at a nuclear plant with cracked
steam generator tubes could cause those tubes to completely
break] has merit and deserves investigation.''
<bullet> ``This seems to be a plausible contention [that an
accident at a nuclear plant with cracked steam generator tubes
could widen the cracks and result in larger leakage], and the
staff has not produced analyses or test results to refute it.''
<bullet> ``The [ACRS] concluded that the issue of the
possible evolution of severe accident to involve gross failure
of steam generator tubes and bypass of the containment is not
yet resolved [and] that the issue needs consideration
regardless of the criteria adopted for the repair and
replacement of steam generator tubes.''
<bullet> ``Data available to the [ACRS] suggest that the
constant probability of detection [of cracked steam generator
tubes] adopted by the NRC staff is nonconservative for flaws
producing voltage signals less than about 0.7 volts.'' [In
other words, the NRC staff assumes that methods used to find
cracked tubes are much better than the data shows them to be.]
<bullet> ``The [ACRS] was unable to identify defensible
technical bases for the [NRC] staff decisions to not consider
the correlation of the iodine spiking factor with initial
iodine concentration [when evaluating the potential offsite
radiation dose consequences from accidents involving cracked
steam generator tubes].''
<bullet> ``The [ACRS] found that the [NRC] staff did not have
a technically defensible understanding of these processes to
assess adequately the potential for procession of damage to
steam generator tubes.'' [In other words, the NRC staff has no
sound basis for arguing that one broken tube will not cascade
and cause the failures of other tubes.]
<bullet> ``The [NRC] staff has not developed persuasive
arguments to show that steam generator tubes will remain intact
under conditions of risk-important accidents in which the
reactor coolant system remains pressurized. The current
analyses dealing with loop seals in the coolant system are not
yet adequate risk assessments.''
<bullet> ``In developing assessments of risk concerning these
design basis accidents, the [NRC] staff must consider the
probabilities of multiple tube ruptures until adequate
technical arguments have been developed to show damage
progression is improbable.'' [In other words, the risk studies
to date, which only consider failure of a single tube, may
understate the true risk and therefore should not be relied
upon.]
The concerns raised by Dr. Hopenfeld are extremely important safety
issues. As the ACRS stated:
<bullet> ``Steam generators constitute more than 50 percent
of the surface area of the primary pressure boundary in a
pressurized water reactor.''
<bullet> ``Unlike other parts of the reactor pressure
boundary, the barrier to fission product release provided by
the steam generator tubes is not reinforced by the reactor
containment as an additional barrier.''
<bullet> ``Leakage of primary coolant through openings in the
steam generator tubes could deplete the inventory of water
available for the long-term cooling of the core in the event of
an accident.''
In the decade since Dr. Hopenfeld first raised his safety concerns,
the NRC has allowed many nuclear plants to continue operating nuclear
power plants with literally thousands of steam generator tubes known to
be cracked. The ACRS concluded that the NRC staff made these regulatory
decisions using incomplete and inaccurate information. After receiving
the ACRS's report, the NRC staff considered Hopenfeld's concerns
``resolved'' even though it had taken no action to address the numerous
recommendations in the ACRS report (enclosure 1).
The NRC must REALLY resolve Dr. Hopenfeld's concerns as soon as
possible. In the interim, the NRC must stop making decisions affecting
the lives of millions of Americans when it lacks ``defensible technical
bases.''
risk-informed regulation
Two of the NRC's four strategic goals are to maintain safety and to
reduce unnecessary regulatory burden. The agency attempts to define
``unnecessary'' using plant-specific risk studies that purportedly draw
a nice clean line between what is necessary and what is not. But UCS
released a report titled ``Nuclear Plant Risk Studies: Failing the
Grade'' last August detailing numerous flaws in the publicly available
plant-specific risk studies. Among other flaws, we compared the risk
study results for three sets of nearly identical plants and found that
they varied widely--not because the risks were that disparate but
because different assumptions and methods were used. Consequently, it
is extraordinarily easy to move that nice clean line simply by tweaking
a few input assumptions and have a burden appear as either necessary or
unnecessary.
For example, the FitzPatrick nuclear plant in New York has a
problem three or 4 years ago with a valve that must open following a
certain accident to provide cooling flow to the reactor core. But the
valve's motor did not develop sufficient thrust to move the valve
against the high pressure that would occur if that accident happened.
Fixing the valve was therefore a very necessary burden. Yet the plant's
owner went back to the risk study and re-calculated the risk from that
accident happening concurrently with a complete failure of the
electrical grid and adjusted the line until the burden became
``unnecessary.'' This example is not sharpening one's pencil because
the accident in question happens most frequently when the electrical
grid remains available. Thus, this vital safety system would not have
functioned properly for the most likely accident scenario.\3\
---------------------------------------------------------------------------
\3\ Fortunately, this unsafe condition has been remedied. The
plant's owner fixed the valve motor at the next scheduled refueling
outage. The bogus risk study was used to allow the plant to continue
running with the non-functional valve for months. The plant's operating
license as granted by the NRC only permitted operation for up to 7 days
with this vital safety equipment inoperable.
---------------------------------------------------------------------------
More recently, the NRC staff allowed Fermi Unit 2 in Michigan to
continue operating after the company broke one of its emergency diesel
generator due to either incompetence or negligence. The company
submitted a risk study to the NRC staff that showed the continued
operation increased the threat of an accident. But the NRC staff
discounted that quantified threat by saying that the unquantified
threat from shutting down and then restarting the nuclear reactor would
somehow pose an even larger threat. This NRC decision contradicts its
own regulations, policies, and procedures and UCS has asked the NRC's
Inspector General to investigate this matter (enclosure 2).
The plant-specific risk studies that UCS reviewed for our report
are nearly 10 years old, but they are the most recent risk studies that
are publicly available. The NRC is allowing plant owners to reduce the
testing frequency for emergency equipment or to continue operating with
degraded equipment based on results from more recent risk studies. The
previously cited ACRS report on Hopenfeld's steam generator tube
integrity concerns indicates that the more recent risk studies remain
inaccurate and incomplete. Members of the public and organizations like
UCS cannot challenge these regulatory decisions because we lack access
to the risk studies. The NRC's own regulations, policies, and
procedures require such information to be publicly available, but it is
not. And the agency continues to make regulatory decisions affecting
the lives of millions of Americans in a vacuum. The NRC must require
the flaws in the risk studies to be corrected AND make sufficient
information about the corrected risk studies publicly available.
nuclear plant security
The NRC's handling of physical security at nuclear reactors is
another example of regulatory ineffectiveness. The NRC began force-on-
force tests of security preparedness at nuclear power plants in the
early 1990's. These tests pit a handful of simulated intruders against
a plant's physical defenses and squadrons of armed security personnel.
By 1998, these tests had revealed significant security weaknesses in
about 47 percent of the plants tested. The NRC quietly discontinued the
testing, but the ensuing public outrage forced the agency to re-
institute the tests. Since the tests have been resumed, about 47
percent of the plants continue to have significant security flaws
revealed. Last year, force-on-force tests at the Waterford plant in
Louisiana and the Quad Cities plant in Illinois demonstrated serious
security problems that warranted extensive repairs and upgrades. The
owner of the Waterford spent more than $2 million fixing its inadequate
security system.
Having been foiled in its attempt to secretly deep-six the security
tests, the agency resorted to Plan B in which they will allow the plant
owners to conduct the tests themselves, grade the tests themselves, and
simply mail in the scores--virtually guaranteed to be high marks--to
the NRC. If someone like Timothy McVeigh drove to a nuclear power plant
with intentions of causing harm, the people living near that plant
would better protected by security scoring 85 percent on a real test
than 100 or even 110 percent on an open-book, take-home, self-scored
test. The public deserves and must get that better protection than that
provided by artificially inflated security test scores.
new nuclear plants
A new nuclear technology called the pebble-bed modular reactor is
getting considerable mention as the type of nuclear reactor most likely
to be built in the United States in the future. The pebble-bed reactor
does offer certain safety advantages--at least, on paper. Proponents
claim that the pebble-bed reactor cannot experience the meltdown-type
accident as occurred at Three Mile Island in 1979. Perhaps, but can the
pebble-bed reactor, which will use more graphite in each reactor module
than is presently used in all existing U.S. nuclear power plants
combined, can on fire and burn as happened at Windscale in 1957 and
Chernobyl in 1986? Can plant workers, either by mistake or by design,
trigger an accident as occurred at the SL-1 nuclear reactor in 1961 and
Dresden Unit 3 in 1974 and Browns Ferry in 1975? Can some unexpected
component failure cause fuel damage, as occurred at Fermi Unit 1 in
1966?
The pebble-bed reactor is rumored to be competitive with other
energy technologies. It appears from a preliminary design review that
the proposed reactor achieves its economic advantages by replacing the
steel-lined, reinforced-concrete containment structures used for our
existing nuclear plants with a far less robust enclosure building. The
NRC's own Advisory Committee on Reactor Safeguards characterized this
as ``a major safety tradeoff.''
The safety problem with the proposed ``containment-lite'' pebble-
bed reactor design Is compounded by the existing security weaknesses.
Imagine the consequences from a fertilizer truck bomb detonated next to
a ``containment-lite'' reactor with millions of curies of lethal
radioactivity to contaminate the environment for many decades. That
would truly be a nuclear nightmare.
Cost projections by the nuclear industry must be taken with a grain
of salt, if not an entire salt shaker. According to the U.S. Department
of Energy, the actual construction costs for 75 nuclear power plants
started between 1966 and 1977 were more than three times higher than
their estimated costs.\4\ Thus, claims that the projected costs of
electricity from a proposed pebble-bed reactor are competitive with the
actual costs of electricity from operating renewable energy
technologies must be viewed with skepticism.
---------------------------------------------------------------------------
\4\ United States Department of Energy, ``Analysis of Nuclear Plant
Construction Costs,'' DOE/EIA-0485 (Washington, DC: 1985).
---------------------------------------------------------------------------
It cannot be overemphasized that a facility like the proposed
pebble-bed modular reactor has never been constructed or operated in
the world. Consequently, its expected performance characteristics are
highly speculative. It would not be prudent at this time to place undue
reliance on a risky technology with unproven safety performance.
Nuclear experiments belong in the laboratory, not within the U.S.
electricity marketplace.
conclusions and recommendations
Nuclear power plants are inherently dangerous. If nuclear power is
to play an expanded role in the future, it is imperative that the
Nuclear Regulatory Commission become a consistently effective
regulator. UCS believes that this goal is attainable. The Maintenance
Rule (10 CFR 50.63) and the revised reactor oversight process
demonstrate that the agency is capable of effective regulation. That
capability must be extended across all of the NRC's oversight functions
and consistently sustained. This transformation may require that the
agency receive additional resources, particularly during the
transformation phase. Because the agency is currently a fee-based
agency, it may require legislative changes to supplement the existing
resources with taxpayer money.
Failing to reform the Nuclear Regulatory Commission could have
tragic consequences. As reported in The Wall Street Journal (enclosure
3), the 1986 accident at the Chernobyl nuclear plant cost the former
Soviet Union several times the net benefits from all Soviet reactors
ever operated. The price tag for the accident was placed at 170 to 215
billion rubles while the net benefits from every Soviet nuclear power
plant was only 10 to 50 billion rubles. With the price of failure so
very high, it is absolutely imperative that the Nuclear Regulatory
Commission be a consistently--rather than occasionally--effective
regulator.
If Congress wants an expanded role for nuclear power, it must
provide the NRC with the resources needed for the agency to implement
consistently effective regulatory programs and must also oversee the
agency's reform efforts to verify that they are successful.
______
Union of Concerned Scientists,
April 13, 2001.
Mr. Hubert Bell, Inspector General,
U.S. Nuclear Regulatory Commission,
Washington, DC.
Subject: Allegation of Improper NRC Staff Action
Dear Mr. Bell: By letter dated March 29, 2001 (enclosure 1), NRC
Region III documented their granting of enforcement discretion to the
Detroit Edison Company to allow the Fermi 2 reactor to continue
operating for an additional 7-day period with one of its emergency
diesel generators broken. After reviewing this letter and the company's
letter dated March 26, 2001, (enclosure 2) that requested it, I
concluded that the NRC staff did not follow the instructions in NRC
Inspection Manual Part 9900, ``Operations--Notices of Enforcement
Discretion'' (enclosure 3) and in NRC Regulatory Guide 1.177, An
Approach for Plant-Specific, Risk-Informed Decisionmaking: Technical
Specifications'' (enclosure 4).
If my conclusion is correct, then it appears that the NRC staff
should not have granted this enforcement discretion and subjected the
people living near the facility to undue risks. I did not survey other
notices of enforcement discretion to determine if the Fermi 2 case is
an isolated one or the tip of an iceberg.
On behalf of the Union of Concerned Scientists, I respectfully
request that the Office of the Inspector General investigate this
Notice of Enforcement Discretion. If your investigators substantiate my
conclusion, I would additionally ask that your investigation examine
other recent Notices of Enforcement Discretion to determine if the
problem is isolated or pervasive.
background
By letter dated March 29, 2001, the NRC's Region III office issued
a Notice of Enforcement Discretion to Detroit Edison allowing the Fermi
2 reactor to continue operating for up to seven more days with a broken
emergency diesel generator. According to the March 26th letter
submitted to the NRC by Detroit Edison, the emergency diesel generator
came to be broken as follows:
The outboard bearing failed suddenly and catastrophically
during an endurance run recently when operated to fulfill
periodic TS [Technical Specification] surveillance
requirements.
EDG-14 was started and loaded for the purpose of performing
the 24-hour endurance surveillance testing per TS [Technical
Specification] Surveillance Requirement (SR) 3.8.1.13, on March
21, 2001 at 1011 hours. At 2206 hours, a generator trouble
alarm was received. It was noted that the EDG 14 generator
outboard bearing temperature was 228 + degrees F and rising
rapidly. The EDG 14 output breaker was opened, and EDG 14 was
manually tripped. One minute later, the operator reported a
fire on the EDG 14 outboard bearing housing.
Detroit Edison stated that the emergency diesel generator broke
because:
The root cause has been determined to be a lower than
adequate oil level in the bearing housing. The oil level was
below the vendor recommended minimum value of six inches below
the centerline of the generator shaft. The actual oil level at
the time of the event was at 6\7/8\ inches below the centerline
of the generator shaft, \7/8\ inch below the recommended
minimum.
The operator indicated that the oil level was at the bottom
of the ``green band.''
The company explained how the oil level came to be \7/8\ inch
(0.875 inch) lower than the recommended minimum:
A stiffener plate was added to the outboard end of the
generator housing [in 1984] to reduce axial vibration on EDG 14
only. This led to a modification of the oil sight glass piping.
It is believed that the oil level sight glass was incorrectly
lowered at that time, thus indicating higher by approximately
0.9 inches than the actual oil level in the bearing.
So the company made a mistake nearly 17 years ago. And the company
reported two recent failures to identify and correct this mistake,
which I will refer to as Missed Opportunity No. 1 and Missed
Opportunity No. 2:
A nonconformance report (DER) was issued [in 1997]
questioning the proper oil levels for the EDG generator
bearings. . . . Operator rounds sheets and the maintenance
procedure were revised with the new oil level tolerances.
[Missed Opportunity No. I]
A site wide program for improving oil level indication
installed oil level ``green bands'' on all EDG generator
bearings [in 1999]. The green band on EDG 14 was erroneously
placed too low using the tick mark that had existed since 1984,
resulting in a higher apparent indication (approximately 0.9
inches) than what actually existed. Maintaining oil in the
green band could result in the oil level being too low. (Missed
Opportunity No. 2]
The company claimed:
This request for enforcement discretion was unavoidable due
to the sudden, rapid degradation of the affected EDG 14
bearing, approximately 12 hours into the 24-hour endurance run,
and was not created by a failure to make a timely application
for a license amendment.
I strongly disagree with the company's assertion of
``unavoidable.'' The company conceded that its error in a 1984
modification was the root cause of the failure. Even if that mistake
was indeed unavoidable--which seems doubtful since other plant owners
have been able to modify their emergency diesel generators without
breaking them--it is hard to understand how the 1997 nonconformance
report specifically written on oil levels and the 1999 green band
effort failed to identify the error. Had the company complied with its
legal obligations under 10 CFR 50 Appendix B in 1984, in 1997, or in
1999--just one act of compliance over a 15-year period--the failure
would have been very avoidable.
The company's point that their request ``was not created by a
failure to make a timely application for a license amendment'' is
irrelevant. They are not seeking a license amendment as a remedy.
Instead, they sought more time to fix the broken emergency diesel
generator that directly resulted from their mistake in 1984 and
oversights in 1997 and 1999. It was very clearly a failure to take
timely corrective actions.
The NRC staff compounded and supplemented the mistakes made by
Detroit Edison by granting the requested enforcement discretion
contrary to the requirements of Inspection Manual Part 9900 and Reg
Guide 1.177. Section B of Inspection Manual Part 9900 states:
Careful regulatory scrutiny should be given to any deviation
from the required actions of the TS [Technical Specifications]
or other license conditions for circumstances involving
violations, poor planning, repeated NOED request for the same
reasons, or some similarly avoidable situation.
As described previously, the company conceded that it had
introduced the flaw to the emergency diesel generator in 1984 and
failed to correct it during specific, targeted examinations in 1997 and
1999. Therefore, it implicitly admitted to three separate and distinct
violations of 10 CFR 50 Appendix B. Absent these repeated violations,
there is no hint, yet alone evidence, that the emergency diesel
generator would have failed during the March 2001 test. Clearly, this
was an avoidable failure that wasn't avoided due to the company's own
incompetence which the NRC staff rewarded with enforcement discretion.
Paragraph 2.1 of Section B of Inspection Manual Part 9900 states:
Granting of this type of an NOED [regular NOED as opposed to
severe weather-related NOED] shall not involve an increase in
radiological risk.
Note that this requirement does not allow a minimal or negligible
increase in risk. This criterion permits no increase in radiological
risk. `No' means `no.'
Detroit Edison conducted a plant-specific risk assessment for
operating the reactor for 14 days with EDG 14 broken compared to the 7
days permitted by the Technical Specifications. The results of that
assessment are documented in the company's March 26th letter to the NRC
and are parroted by the NRC staff in its March 29th letter:
The results showed an incremental conditional core damage
probability of 2.08E-7 and an incremental conditional large
early release probability of 3.66E-8.
Thus, both the company and the NRC explicitly reported an increase
in radiological risk. But the NRC approved the enforcement discretion.
Apparently, `no' means `maybe' to the NRC staff.
It appears that the NRC staff justified this very clear violation
of the explicit criterion in NRC Inspection Manual Part 9900 on this
basis:
Your submittal [i.e., Detroit Edison's March 26th letter]
also stated that eliminating the plant shutdown required by the
Technical Specifications would eliminate consequent
transitional risk associated with a shutdown and startup of the
plant, offsetting the risk associated with the increased time
of the diesel outage and resulting in a minimal effect on plant
safety.
Neither the staff's letter nor the company's letter provides a
qualitative assessment of the alleged transitional risk. Consequently,
the quantitative assessment showing a risk increase is opposed by a
subjective, undocumented, non-qualitative, non-quantitate assessment
(i.e., hand-waving). Paragraph 4.0 of Section B of NRC Inspection
Manual Part 9900 states:
The safety basis for the request, including an evaluation of
the safety significance and potential consequences of the
proposed course of action. This evaluation should include at
least a qualitative risk assessment.
In this case, Detroit Edison submitted the results from their
quantitative assessment showing an increase in both core damage
probability and large early release probability. Yet the staff
dismissed those results and accepted an undocumented, unreported, non-
qualitative assessment by the company that shutting down and starting
back up posed a greater risk.
I had a conference call with Mr. Mark Ring, Mr. Steve Reynolds, and
Mr. John Grobe of the NRC Region III staff earlier this week regarding
this Notice of Enforcement Discretion and its alleged justification.
Mr. Grobe concurred with my observation that the purported risk from
shutting down and starting up had not been quantified by the company or
by the NRC staff. He explained that current probabilistic risk
assessment methods are not evolved enough to evaluate all the complex
variables associated with shutting down and restarting a reactor. If
that is true, how can the NRC staff have confidence that this
unquantifiable risk is less the quantifiable risk from continuing to
operate the reactor with a broken diesel generator?
Section A of Reg Guide 1.177 states:
PRA [probabilistic risk assessment] evaluations in support of
regulatory decisions should be as realistic as practicable and
appropriate supporting data should be publicly available for
review.
The results from the quantitative assessment submitted by Detroit
Edison and parroted by the NRC staff simply do not satisfy either the
spirit or the letter of the ``appropriate supporting data should be
publicly available for review'' standard. In addition, there was
absolutely no information provided on the alleged transitional risk to
assess whether it satisfied the ``as realistic as practicable.'' For
all I know, the company based its statement on a guess. Maybe it was
even a hunch. Perhaps they used a round or two of ``paper/rock/
scissor.'' But it very clearly was not ``at least a qualitative
assessment'' with ``appropriate supporting data'' ``publicly available
for review.'' And for that reason, the NRC staff should not have
granted Detroit Edison's wishes. But it did.
conclusions
(1) The failure of emergency diesel generator 14 in March 2001 was
entirely avoidable if the company (a) had not made an error during a
modification back in 1984, (b) had not failed to identify and fix the
error while resolving a nonconformance report in 1997, and (c) had not
failed to identify and fix the error while specifying proper oil levels
in 1999.
(2) The failure of emergency diesel generator 14 in March 2001
resulted from repeated violations of 10 CFR 50 Appendix B by the
company.
(3) The NRC staff did not exercise ``careful regulatory scrutiny''
for ``violations . . . or some similarly avoidable situation'' when it
reviewed the request for enforcement discretion.
(4) The NRC staff violated NRC Inspection Manual Part 9900's
criterion that ``an NOED shall not involve an increase in radiological
risk'' because the company's only qualitative assessment reported. an
increase both in core damage probability and large early release
probability.
(5) The NRC staff violated NRC Inspection Manual Part 9900's
criterion that the company's evaluation ``should include at least a
qualitative risk assessment'' because the staff accepted an ill-
defined, quantitative assessment that the risk from shutting down and
restarting the reactor was somehow greater than the results from the
qualitative risk assessment for continuing to operate the reactor with
one emergency diesel generator known to be broken (since the company
broke it).
(6) The NRC staff violated NRC Regulatory Guide 1.177's criterion
that ``appropriate supporting data should be publicly available for
review'' since only the results from the qualitative assessment for
continuing to operate the reactor with one emergency diesel generator
known to be broken are publicly available. The company's guess--or
hunch--and the NRC staff's confirmatory guess--or hunch--is not
publicly available.
(7) The NRC staff did not conform with NRC Inspection Manual Part
9900 and Regulatory Guide 1.177 and therefore should NOT have granted
enforcement discretion in this case.
I respectfully request that your office determine if my conclusions
are valid. I would be glad to meet with your staff to further explain
my concerns about this matter.
Sincerely,
David A. Lochbaum,
Nuclear Safety Engineer.
______
[From The Wall Street Journal, Thursday, March 29, 1990]
Cost of Chernobyl Nuclear Disaster Soars in New Study--1986 Reactor
Accident Dwarfs Other Soviet Peacetime Catastrophes
(By Richard L. Hudson, Staff Reporter)
MOSCOW--A new Soviet study concludes that continuing
economic fallout from the Chernobyl nuclear accident may cost
20 times more than Moscow's prior estimates, ranking Chernobyl
as the most costly catastrophe in Soviet peacetime history.
The study, by a Soviet nuclear industry economist,
estimates that by the year 2000 the Chernobyl accident may cost
the country 170 billion to 215 billion rubles in lost
electricity production, contaminated farmland and other
economic consequences. Moscow's previous estimate, which
counted only the immediate cleanup costs, was 10 billion
rubles.
Because the ruble isn't freely convertible, the new
estimate can't be expressed accurately in Western currencies.
At the official exchange rate in Moscow, it amounts to $283
billion to $358 billion. In any currency, the sum far exceeds
cost estimates for such previous Soviet disasters as the 1988
Armenian earthquake. The April 26, 1986, accident was the ``the
biggest socioeconomic cataclysm in [peacetime] history,'' the
study says, adding that Chernobyl also contributed to the
country's worsening economic problems.
internal debate is mounting
The study supports Western speculation that Moscow initially
underestimated Chernobyl's cost. But its scheduled publication in
Soviet news media this year will contribute to a mounting internal
debate over the accident's cleanup costs. Local government officials
near the Ukranian reactor are pressing Moscow to provide 35 billion
rubles in projected cleanup expenses. And the Supreme Soviet, the
country's standing parliament, plans a public debate on the issue later
this year.
The report was commissioned by a participant in this debate, and is
thus a rare example of a Soviet special-interest group learning such
Western lobbying techniques as commissioning research. The study's
sponsor was the Chernobyl Union, an organization of accident survivors
pressing Moscow for more aid. The economist who performed the study is
Yuri Koryakin, chief economist of the Research and Development
Institute of Power Engineering, a Soviet government institute that
designed the Chernobyl reactor. In an interview, Mr. Koryakin said he
agreed to conduct the study in the interests of promoting wider public
debate about the Chernobyl accident.
Mr. Koryakin's findings will likely be contested by some Soviet
officials. But to minimize official criticism, he said, his study used
only information pulled from previous Soviet publications--and avoided
use of any of his institute's official, non-public documents. He said,
however, that he believes his study is the first anywhere in the Soviet
government to attempt to add together all the direct and indirect
accident costs.
Cleanup and study of the Chernobyl accident has become a major,
permanent segment of Soviet industry. The accident, caused when
operators lost control of a reactor, spewed radiation for days over the
surrounding Ukranian, Byelorussian and Russian countryside. It forced
the permanent evacuation of thousands, and contaminated about 31,000
square kilometers (12,400 square miles) of farmland and forests with
long-lived radioactive cesium, strontium and other elements.
By Mr. Koryakin's estimates, the cost of losing agricultural
production on the contaminated land is among the single biggest costs
of Chernobyl to the Soviet economy. From 1986 to 2000, the lost land
value totals 57.5 billion to 94.5 billion rubles. A few years ago,
Soviet scientists were blithely forecasting a quick return to
agriculture by, for instance using special breeds of cattle and
switching them to imported, non-radioactive feed a few weeks before
slaughter. But lately such optimistic talk has died out, leading some
specialists to consider the contaminated land a total loss for at least
two generations.
lost electricity production
The second-biggest economic consequence of Chernobyl, Mr.
Koryakin's study says, is lost electricity production--valued at about
66.8 billion rubles through 2000. Following the accident, Soviet public
opinion turned sharply against nuclear power, and Soviet authorities
were forced to halt or cancel plans for 32 nuclear power reactors.
In some areas of the Soviet Union, the nuclear cutbacks have
worsened power shortages. For instance, closure of two reactors in
Armenia cost the Transcaucasus region 15 percent of its power supply,
leading to restrictions in local electricity consumption. Also, post-
accident safety projects at many of the country's other reactors will
raise their average electricity costs by 0.08 kopecks a kilowatt-hour,
or 9 percent, the study says.
Gradually decontaminating the countryside, evacuating people and
completing other cleanup tasks may cost 35 billion to 45 billion rubles
through 2000, the study says. Other costs include 3.9 billion to 5.1
billion rubles to install new safety equipment at Soviet reactors, and
the loss of five billion rubles in capital invested in reactors closed
after Chernobyl.
The total bill suggests that the Soviet Union may have been better
off if it had never begun building nuclear reactors in the first place.
Since the Soviets opened their first power reactor in 1954. Mr.
Koryakin estimates, the net economic contribution of the Soviet nuclear
has been 10 billion to 50 billion rubles. The sum is a measure of how
much money the country saved by using cheaper, nuclear-generated
electricity than more costly coal-burning plants. The Chernobyl
accident costs exceed that sum by several times.
______
Responses by David Lochbaum, to Additional Questions from Senator Reid
Question 1. In your testimony, you indicated the public does not
have access to risk studies that are crucial to the new reactor
oversight program. Are there other problems in regard to public access
to documents, staff, and Commissioner? How does the recent proposal to
remove the formal hearing structure affect this?
Response. Yes, there are other problems in regard to public access
to documents. On October 29, 1999, the NRC announced an electronic
library for its documents.\1\ The NRC stated:
---------------------------------------------------------------------------
\1\ Nuclear Regulatory Commission, News Release No. 99-232, ``NRC
Makes Documents Available to the Public on its Website,'' October 29,
1999.
The Nuclear Regulatory Commission has begun making documents
available to the public through an ``electronic reading room''
on the agency's website, which is accessible by computers in
homes, schools, offices, and libraries, using a standard web
browser.
The site is ``user-friendly,'' and contains easily
understandable instructions for searching, viewing and
downloading documents.
However, this ``electronic reading room,'' called ADAMS, is neither
``accessible'' nor ``user-friendly.'' In order to use the software that
the NRC adopted to interface with ADAMS, users must alter the
communication protocols of their computers, commonly referred to as
``dropping the fire-walls.'' These communication protocols are intended
to prevent hackers from unauthorized access to users' computer systems.
Therefore, many users, particularly schools, offices, and libraries,
have not ``dropped the fire-walls'' and cannot enter the NRC's
electronic reading room.
Even if one is fortunate enough to be able to enter the electronic
reading room, there are still major problems. Documents are stored in
ADAMS in either PDF or TIFF format. The TIFF format is extremely large.
For example, UCS downloaded a 26-page document from ADAMS earlier this
week. In TIFF format, the file was over 2.4 Mb in size. Documents must
be downloaded from ADAMS because the NRC's interface software does not
allow single pages to be printed out. UCS had to download an entire
transcript in TIFF format that was over 15 Mb in size just to be able
to print out selected portions. The unnecessarily large file size means
that public stakeholders cannot go to public libraries and download
files to a floppy diskette (1.44 Mb maximum capacity) for later use in
their homes.
At stake is not simply greater convenience. In conjunction with
opening the electronic reading room, the NRC effectively closed local
public document rooms across the United States by refusing to send them
records. Consequently, these local public document rooms do not have
records since late 1999.
In many communities, members of the public cannot access the NRC's
electronic reading room and can no longer go to their local public
document rooms to access contemporary documents. The NRC's actions have
had the effect of barring public access to information about the
nuclear facilities in their backyards.
UCS formally asked the NRC Chairman to take specific measures to
offset the damage done by the shift to the inaccessible electronic
reading room. For example, we asked that public comment periods be
increased by 100 percent until the ADAMS problems were remedied.\2\
Most public comment periods last 30 days. We asked for 30 more days to
compensate for the undue burden that had been placed on the public in
having to obtain documents through alternative methods. Our very
reasonable request was summarily rejected. It is baffling that an
agency that claims to have ``improve public confidence'' as one of only
four strategic goals would take such a cavalier attitude.
---------------------------------------------------------------------------
\2\ Letter dated September 22, 2000, from David Lochbaum, Union of
Concerned Scientists, to Dr. Richard A. Meserve, Chairman, Nuclear
Regulatory Commission.
---------------------------------------------------------------------------
UCS is very concerned about the proposal by the NRC to change from
a formal hearing process to an informal hearing process. The informal
hearing process means that the public gives up its rights to discovery
and cross-examination. The NRC has stated: \3\
---------------------------------------------------------------------------
\3\ Nuclear Regulatory Commission, ``Reporting Safety Concerns,''
NUREG/BR-0240, Revision 1, available on the web at http://www.nrc.gov/
NRC/NUREGS/BR0240/Rl/index.html
In the past, workers in NRC-regulated nuclear activities and
concerned citizens have raised important safety issues and, as
---------------------------------------------------------------------------
a result, public health and safety have benefitted.
The key phrase here is ``in the past.'' If the NRC is successful in
foisting its informal hearing process on the American public, concerned
citizens will have virtually no ability to raise important safety
issues with the NRC. As the NRC concedes, this cannot benefit safety.
UCS is particularly disappointed by the approach the NRC is taking
towards informal hearing processes. It wants to make informal hearings
the standard, or at least to only grant formal hearings when the agency
chooses. Contrast that treatment of public stakeholders with how the
NRC is treating plant owners. The NRC is pursuing a number of so-called
risk-informed regulatory improvements. But the NRC intends to make them
voluntary so plant owners can stick with the existing regulations or
adopt the new regulations--whichever they want. Why can't the NRC
permit its public stakeholders to choose between formal and informal
hearings as it allows plant owners to choose between prescriptive and
risk-informed regulations?
Question 2. Do you expect the industry to build a new plant in the
next 10 years without significant Government subsidization?
Response. While we cannot rule out the possibility of an un-
subsidized nuclear plant being built, it appears more likely that
subsidization will be required. UCS attended the public meeting held in
late January 2001 between representatives of the Exelon Corporation and
the NRC staff. Exelon asked the NRC staff to figure out how the
Government could pay for the NRC's review of the pebble-bed modular
reactor. This would clearly be subsidization.
During the Senate Subcommittee hearing on May 8, Mr. Oliver
Kingsley of Exelon testified that it was imperative that Congress
extend the Price-Anderson Act to cover new reactor designs. Currently,
plant owners must obtain liability coverage up to $200 million. If an
accident resulted in damages above $200 million, other plant owners
could be dunned up to $10 million per reactor per year for 10 years.
Payment for damages above that point (approximately $9 billion) would
be up to Congress to decide whom to invoice. Obviously, plant owners
would be forced to pay higher premiums if they had to cover their
entire liabilities instead of only the first $200 million. This
represents another subsidy requested by the industry for new reactors.
Question 3. Are there issues relating to worker fatigue and forced
overtime that you believe could affect the safe operation of the
nuclear power plants. Is the Commission taking steps to address those?
If not, what should be done?
Response. Yes. The NRC received a petition for rulemaking dated
September 28, 1999, that seeks to revise NRC's regulations to provide
uniform, enforceable working hour limits. UCS formally supported, and
continues to support, that petition. UCS had issued a report earlier
that year \4\ that documented scientific evidence that human
performance is impaired by fatigue to the same, or higher degree, than
by alcohol consumption. The NRC promulgated regulations, 10 CFR Part 26
or the Fitness-For-Duty rule, that ensure nuclear plant workers are not
impaired by drug or alcohol usage. Yet data compiled by the Nuclear
Energy Institute \5\ clearly show that some plant owners require
workers to become fatigued on the job. For example, there were nearly
7,000 deviations from the working hour limits at one nuclear plant in
1999 alone, or an average of nearly one deviation every hour for an
entire year. On the other hand, the data also clearly show that many
plant owners are able to comply with the working hour limits. So, it is
possible to avoid the increased threat from fatigued workers if the NRC
would simply adopt and enforce consistent working hour limits.
---------------------------------------------------------------------------
\4\ Union of Concerned Scientists, ``Overtime and Staffing Problems
in the Commercial Nuclear Power Industry,'' March 1999.
\5\ Letter dated August 29, 2000, from James W. Davis, Nuclear
Energy Institute, to Glenn M. Tracy, Nuclear Regulatory Commission.
---------------------------------------------------------------------------
The NRC staff is working on the petition for rulemaking, but it is
not on the fast track. Since it is only a safety issue, it must take a
backseat to efforts being undertaken by the NRC staff to improve the
financial performance of the nuclear fleet. The American public would
be better served if the NRC Commission directed its staff to place
priority on safety rather than on economics. Both are important and
worthy of NRC effort, but safety should not continue to be the NRC's
second priority.
__________
Statement of Oliver D. Kingsley, Jr., President and Chief Nuclear
Officer; Exelon Nuclear, Exelon Generation Company, LLC
Mr. Chairman and members of the subcommittee: I appreciate the
invitation to appear before the subcommittee to discuss the state of
the nuclear energy industry and the role that nuclear power can play in
meeting America's future energy needs. My name is Oliver D. Kingsley,
Jr., and I am the president and chief nuclear officer of Exelon
Nuclear, the nuclear division of Exelon Generation Company.
Exelon Generation is a wholly-owned subsidiary of Exelon
Corporation. Exelon was formed last year by the merger of Unicom
Corporation of Chicago and PECO Energy Company of Philadelphia. Exelon
Generation currently owns and operates approximately 37,000 megawatts
of diversified electrical generation, including 17 nuclear reactors
that generate 16,970 megawatts of electricity. We have another 8,500
megawatts of non-nuclear generation under construction or development.
Exelon is the largest nuclear generation operator in the country with
approximately 20 percent of the nation's nuclear generation capacity,
and the third largest private nuclear operator in the world. We also
own 50 percent of AmerGen Energy, which is a partnership with British
Energy of Edinburgh, Scotland. Amergen owns three of the 17 units in
the Exelon fleet.
the state of the industry
The nuclear industry is receiving substantial public attention as
policymakers evaluate options for maintaining a clean, safe, reliable,
and low-cost energy supply for the United States. The renewed focus on
nuclear energy is due to a variety of reasons:
<bullet> Nuclear has a proven track record of safe and improving
operations;
<bullet> Nuclear power is economically competitive;
<bullet> Nuclear capacity is increasing, even without building new
plants;
<bullet> Prospects for license extension for existing plants are
positive; and
<bullet> The current regulatory environment is stable and
constructive.
The nuclear energy industry is contributing safe, cost competitive,
and reliable baseload power to meet the nation's energy needs, all
without emitting any air pollutants or greenhouse gases associated with
fossil-fired plants.
Nuclear Power is Economically Competitive
Let me highlight the current economics of nuclear power production.
In our vernacular, the total cost of producing electricity from a power
plant is known as the ``all-in'' cost. Current, well-managed nuclear
plants have an all-in cost of less than 2.5 cents per kilowatt-hour
(kWh). This cost compares favorably with the all-in cost for combined
cycle natural gas plants at 3.5 to 4.5 cents per kilowatt-hour
(assuming a gas price of $3 to $4 per million BTUs). Natural gas prices
paid by electricity generators have doubled in the past year and are
likely to continue to exceed historical costs. In contrast, nuclear
fuel costs have been substantially less volatile. For the industry as a
whole, nuclear production costs in 1999 of 1.83 cents per kilowatt-hour
were lower than production costs for coal (2.07 cents per kilowatt-
hour), natural gas (3.52 cents per kilowatt-hour, even prior to natural
gas price spikes) or oil (3.18 cents per kilowatt-hour).
The recent crisis in California has led policymakers to focus on
the need for a sound, comprehensive national energy strategy. Clearly,
our national energy policy should include recognition of the important
role that nuclear power has played--and will continue to play--in
meeting the nation's growing energy needs and addressing clean air
goals.
Nuclear Capacity is Increasing--Without Building New Plants
Even though we have not constructed any new nuclear power plants in
our country in recent years, our nation's nuclear capacity is
increasing. Two things are happening: we are adding capacity at
existing plants and we are operating those plants more efficiently. For
example, Exelon Nuclear is adding nuclear capacity through a
combination of power uprates and plant modifications that will improve
the efficiency of the units. Through these modifications and improved
operation, Exelon Nuclear will increase net generation from its current
fleet by approximately 9 million-megawatt hours by 2003, the equivalent
of adding a new 1,200 megawatt plant. Our planned power uprates will be
achieved at a construction cost $300-$400 per kilowatt, well under the
cost of $500 to $700 per kilowatt for a new combined cycle natural gas
plant, and $1,000 to $1,250 per kilowatt for new clean coal
technologies. Other utilities are doing the same.
Prospects for License Extension are Positive
The long-term prospects for our nation's nuclear fleet are also
positive, defying some predictions. As recently as 1997, the NRC
estimated that only a fraction of currently operating reactors would
seek to extend their operating licenses. Today, most observers,
including NRC Chairman Meserve, predict that the vast majority of the
nation's 103 operating plants will apply for 20-year license
extensions. Between 2001-2003, Exelon will submit license renewal
applications to the NRC for the Peach Bottom, Dresden and Quad Cities
nuclear power plants, and we are reviewing the potential for license
renewal for the remainder of the Exelon fleet.
With the forces of market competition reshaping the entire
electricity industry and driving down the cost of electricity, nuclear
power's competitiveness will continue to hinge, in part, on how well
Federal regulations keep pace with industry changes.
Current Regulatory Environment is Stable and Constructive
The current regulatory environment has become more stable, timely,
and predictable, and is an important contributor to improved
performance of nuclear plants in the United States. This means that
operators can focus more on achieving operational efficiencies and
regulators can focus more on issues of safety significance. It is
important to note that safety is being maintained and, in fact
enhanced, as these benefits of regulatory reform are being realized.
The Nuclear Regulatory Commission and this Subcommittee can claim a
number of successes in their efforts to improve the nuclear regulatory
environment. These include successful implementation of the NRC Reactor
Oversight Process, the timely extension of operating licenses at
Calvert Cliffs and Oconee, the establishment of a one-step licensing
process for advanced reactors, the streamlining of the license transfer
process, and the increased efficiency in processing licensing actions.
NRC Reactor Oversight Process
While Exelon Nuclear is proud of the work that we have done to
improve our operations and production, we must note that many of these
improvements have been facilitated by regulatory changes. A fine
example of this is the NRC Reactor Oversight Process, which has created
greater certainty and predictability in the regulatory environment. I
want to recap some of the progress made to date while indicating areas
where additional improvements are needed.
The Reactor Oversight Process (ROP) is a decided improvement over
the previous process. The new approach is objective, safety-focused,
predictable and more understandable to the industry and the public. In
most cases the process has been demonstrated to objectively distinguish
levels of safety performance and to consistently apply the prescribed
levels of NRC oversight to these differing levels of performance. This
safety focus of the NRC enables us to continuously sharpen our safety
focus while more efficiently applying our resources to ``do the right
thing right the first time''. This improved focus also serves to
reinforce the industry's obligation to find and fix our own problems.
But more importantly it places the accountability for safe and
efficient operation squarely where it belongs with us, the nuclear
operators.
The NRC, working closely with its stakeholders, has achieved a
largely revised and vastly improved regulatory framework for NRC
oversight of licensees in a short amount of time. I cannot fail to
acknowledge the vital role that the Nuclear Energy Institute has played
in helping the industry establish improved communications and a
cooperative working relationship with the NRC. This relationship only
exists as the result of proper execution of our regulatory processes
combined with industry-wide continued good performance.
Both the industry and the NRC are continuing to properly prioritize
and pursue process improvements that reflect the lessons learned from
the initial year of implementation of the Reactor Oversight Process. An
important initiative to achieve common industry performance indicators
is in progress that will sharpen the focus on risk significant
conditions, reduce undue burden caused by differing definitions, and
address perceived concerns regarding inconsistencies.
sustaining the nuclear option
In addition to the progress that has been made on the previously
mentioned issues, there remain many regulatory and legislative actions
needed to continue this progress and set the stage for construction of
new plants. In order to sustain the nuclear option we need:
<bullet> A reliable, competitive nuclear fuel market;
<bullet> Legislative and regulatory reforms;
<bullet> A stable new plant regulatory framework;
<bullet> Renewal of the Price-Anderson Act;
<bullet> Public funding for first-time costs;
<bullet> Enhanced nuclear research and development programs;
<bullet> To retain and attract top talent;
<bullet> Environmental policy must recognize the advantages of
emission-free electricity; and
<bullet> Proper alignment of NRC resources.
I would be remiss if I do not mention the urgent need for the
government to complete the work necessary to build a geologic
repository for used nuclear fuel. Until the Federal Government can
implement a disposal program and resolve the issue of used fuel
disposal, garnering public support for new nuclear units will be a
difficult challenge.
Need for a Reliable, Competitive Nuclear Fuel Market
Nuclear plants have enjoyed a high degree of reliability with
regard to fuel supply, with the vast majority of uranium and enrichment
services provided domestically. The nuclear industry has also benefited
from a relatively competitive market for fuel and fuel services in
recent years, which has kept prices for enrichment services relatively
low. This has been important in making nuclear energy competitive with
other energy sources because fuel is one of the largest single
components in the cost of generating electricity. A fair and open
competitive market for enrichment services must be maintained to
prevent the possibility of dramatic increases in the cost of nuclear
fuel. However, pending anti-dumping and countervailing duty allegations
raised by the United States Enrichment Corporation (USEC) threaten to
result in a single source of enrichment services in the United States.
Should USEC prevail in the pending trade actions, nuclear utilities in
the United States anticipate fuel cost increases of between $650 to
$1,250 million per year for the industry as a whole.
USEC is also attempting to retain its position as the sole
Executive Agent for implementation of the U.S-Russian Highly Enriched
Uranium (HEU) Agreement. If USEC is permitted to retain exclusive
access to enriched uranium brought into the United States under the HEU
Agreement, they will further limit potential competition in the
enrichment market. A competitive fuel market is essential to ensuring a
reasonably priced fuel supply for nuclear reactors and, consequently
for consumers.
Legislative and Regulatory Reforms are Needed
We strongly believe that the safety philosophy embodied in the
Reactor Oversight Process should be codified in regulations to further
institutionalize this important change. In addition, existing
duplicative and inconsistent radiation protection standards between
Federal agencies must be resolved and ultimate authority for those
standards should rest with the NRC. We also agree with the NRC's
recommendations for legislation that would improve the Commission's
flexibility in decisionmaking and reduce unnecessary regulatory burden.
However, if prohibitions on foreign ownership are lifted, we feel that
doing so should be tied to providing reciprocal rights for U.S.
companies to compete overseas.
Stable New Plant Regulatory Framework Needed
The time is right for the next generation of nuclear plants to
emerge as an element in the national energy mix. What will it take for
new nuclear plants to be built in the United States? The answer to that
question has changed in recent years as the nation's electric industry
has been restructured. In addition to being safe, reliable, and clean,
new plants have to possess an additional characteristic: as merchant
plants, they must be economic. New plants must be able to compete with
cleaner coal and natural gas technologies, take less time to construct,
and require lower initial investments. In today's environment, a new
nuclear plant must be relatively small (in terms of generating
capacity) so as not to disrupt the economics of the regional power
market that the plant is built to serve.
Above all, we need a licensing process that provides predictable
outcomes for applicants. Since the last plants were licensed, numerous
changes have taken place in the NRC regulations that support licensing
of new plants. However, many of these changes have not been tested in
actual licensing proceedings. Moreover, the process needs to be able to
accommodate new license applications for merchant plants including
small, modular designs.
In order to move forward with the implementation of new reactor
technologies, additional design and licensing work is required; so are
regulatory changes. We must further reduce the uncertainty of the one-
step licensing process contained in 10 CFR Part 52. Part 52
contemplates a one-step process to site, design, construct, and operate
a new plant. We applaud the goal of a one-step process and believe that
such a process is essential. However, we believe that additional work
on the process will be necessary, particularly when it comes time to
license a gas-cooled reactor.
We need a safety-focused and risk-informed technical licensing
framework for new reactors that embodies the NRC's safety philosophy.
We also need changes to regulations to make them compatible with
applications for so-called ``merchant'' plants. These changes should
include eliminating the need for decommissioning funding assurance and
analysis of transmission system stability. Informal hearing procedures
should be extended to a wider array of licensing actions while ensuring
continued opportunities for public participation. Existing regulations
should be reviewed for their potential adverse impact on small, modular
designs. NRC fees should be assessed on a ``per site'' basis rather
than by the number of reactors. Minimum licensed operator staffing
levels should be addressed.
Price-Anderson Act Must be Renewed
Most importantly, we believe the Price-Anderson Act should be
renewed indefinitely. However, treatment of modular reactors under the
Price Anderson Act must be clarified to avoid the situation where a 10-
module, 1100 megawatt plant faces 10-times the liability of a single-
unit 1100 megawatt plant.
Need for Public Funding for First-Time Costs
Some form of cost-sharing between the Department of Energy and the
private sector may be needed to efficiently and effectively apply the
financial resources needed to cover the first-time costs associated
with implementing the one-step licensing process contained in 10 CFR
Part 52, the cost of developing an advanced reactor licensing framework
to be used by the NRC, and the cost of developing the technical
expertise needed by the NRC and its consultants to review a new plant
application.
DOE funding support must be focused on both near-and long-term
design developments. Forms of potential DOE support could include:
<bullet> Design approval support for the industry or the NRC;
<bullet> Financial support for demonstration projects for first-of-
a-kind/untested processes or technologies;
<bullet> Development of training programs on emerging technologies
(e.g., gas-cooled reactors) that will better enable industry, political
leaders and regulators to understand the new technologies and to render
well-informed decisions.
Enhanced Nuclear Research and Development (R&D) Programs
Exelon believes that the Nation is at a critical juncture in
securing adequate energy resources for the future. Federal support of
nuclear R&D programs that enable continued performance improvements for
current nuclear plants and timely siting, design, licensing and
construction of new nuclear plants should be high priority for the
Congress and the Administration.
Improvements in technology have been a major contributor to the
improved safety, unit capacity, reliability and cost performance of
current U.S. nuclear units and to electricity consumers. Exelon has
realized operational and safety benefits of nuclear R&D in many areas
(e.g., predictive maintenance, advanced fuel designs, analytical
computer models, digital instrumentation and control upgrades, and
probabilistic risk assessment tools).
Further research and development is needed to support new nuclear
plants in the areas of new reactor and fuel design, code verification
and standards development, establishment of a top-down safety-focused
and risk-informed regulatory framework, selected materials research
projects and process demonstration projects (i.e., early site
permitting).
To support a comprehensive national energy policy, R&D funding
should support near-term deployment as well as longer-term advancements
in reactor design alternatives. Nuclear R&D funding must also be made
available to universities supporting nuclear technology degree programs
(engineering, physics, materials, etc.) so that these programs can
increase in size. This support for university programs leads to the
development of high quality nuclear professionals to sustain the U.S.
nuclear infrastructure.
Retain and Attract Top Talent
Nuclear stakeholders must band together to address short and
longer-term staffing needs. At Exelon, 69 percent of our nuclear
workforce is over 40 with 19 percent over 50. A similar analysis by the
NRC of their own workforce demographics yielded more extreme results.
We need a viable feeder group of nuclear professionals to operate and
maintain our plants. Nuclear industry suppliers and associations will
need this talent to preserve the nuclear industry infrastructure.
Government agencies such as DOE, NRC, and the national laboratories
will need this talent to carry out their respective missions.
Universities will need new faculty to conduct research and to educate
future generations of nuclear professionals.
In order to retain and attract the top talent, it is imperative to
create and sustain a favorable environment for nuclear energy that
sends a clear message that nuclear professionals have expanding
opportunities with bright futures. We each have a part to play through
our support of university programs involving nuclear technologies;
through nuclear R&D funding; through achievement of regulatory reform
and investment in license renewal and new nuclear technologies. Each of
these actions sends a message.
Exelon helped to create and remains active in the DOE/Industry
Matching Grant Program for University Nuclear Engineering Departments.
This program has had a major impact in improving the educational
infrastructure for supplying nuclear engineers and has allowed the
departments to enhance the quality of their programs. In the upcoming
fiscal year, the DOE has 23 universities and 37 sponsors vying for
funding under the Marching Grant Program. Exelon remains actively
involved with nuclear programs at several universities in Illinois,
Pennsylvania, and Wisconsin. However, a national program is needed to
support a strategic energy policy.
Environmental Policy that Recognizes Nuclear Advantages
The Federal Governmental should treat all energy sources similarly
with regard to environmental regulation. Support for environmentally
beneficial methods of generation should be based on objective,
scientific criteria that accurately measure potential adverse impacts
from such generation for all environmental media and resources, taking
into account the actual amount of electricity that could be produced.
For example, an ``environmentally preferable power'' certification
system could be developed that would recognize nuclear efficiency
projects as environmentally preferable. In addition, measures to obtain
economic value for nuclear energy's role in avoiding emissions of air
pollutants and greenhouse gases, such as emissions allowances or credit
for avoided carbon dioxide emissions, should be put in place. Further,
any future legislation to implement global warming programs should
provide nuclear efficiency improvements with carbon dioxide credits or
provide similar recognition of nuclear's valuable role as an emissions-
free energy source.
Proper Alignment of NRC Resources
In light of all the changes and challenges that the NRC must
manage, proper allocation of resources will be critical to the
Commission's success. The stability of the regulatory environment
hinges, in part, on the NRC's ability to establish a proper balance and
priority between existing reform efforts and new initiatives.
Through a more robust strategic planning process, the NRC has taken
steps to keep pace with industry restructuring and to ensure that the
Commission can continue to be supportive of our country's growing
energy needs. The NRC is updating its blueprint for its transition to a
more risk-informed regulatory framework and has recently increased its
focus on the licensing of new nuclear plants. Effective implementation
of the Reactor Oversight Process and achievement of efficiencies in
other areas can enable NRC resources to be realigned to meet the future
demands it will face.
Exelon believes that the following areas will require significant
NRC attention and resources over the next 5 years:
<bullet> Efficient processing of license renewal applications;
<bullet> Licensing of generation improvements (e.g., 24-month
operating cycles, power rating increases);
<bullet> Licensing of new nuclear technologies (e.g., steam
generator programs, advanced non-light water reactor designs);
<bullet> Licensing of a geologic repository for used nuclear fuel;
and
<bullet> Further regulatory reforms (e.g., risk-informed
regulation, regulatory burden reduction, and further Reactor Oversight
Process improvements).
Exelon supports the analysis and redeployment of NRC operations to
reflect the need to simultaneously support multiple strategic
initiatives while keeping its eye on the ball properly executing its
core mission to protect public health and safety.
the pebble bed modular reactor project
To provide a context for the changes I just described, let me
describe Exelon's plans. Exelon Generation has evaluated various
technologies and options for future electricity generation and has
determined that small, modular nuclear power plants could provide a
competitive advantage in the deregulated wholesale power marketplace.
These plants could also make a significant contribution to the
reduction of greenhouse gases and air pollution usually attributed to
electric generation. As a result, we have invested in a joint venture
to study the feasibility of an advanced nuclear reactor design called
the Pebble Bed Modular Reactor (PBMR). These reactors are small (110-
125 megawatts), modular, gas-cooled designs intended for merchant plant
installations anywhere in the world. This technology is currently being
developed in the Republic of South Africa. We are investigating the
technical, licensing, and economic feasibility of building new power
plants based on this technology in the United States.
The key advantages of this technology appear to be:
<bullet> Increased nuclear safety;
<bullet> Minimal environmental impact with no greenhouse gas
emissions;
<bullet> Low capital and operating costs;
<bullet> Stable fuel costs;
<bullet> Short construction time; and
<bullet> The flexibility to add incremental capacity in regional
markets to economically match load growth.
We believe that these advantages are clearly in both our
competitive interest and in the national interest.
If the technology is deemed ready for commercialization, and if the
economics prove to be competitive against other forms of generation,
Exelon and its partners will proceed to build a demonstration plant in
South Africa near Cape Town. Construction of that plant will take
approximately thirty-six months, followed by a twelve-month testing
period.
If Exelon's review of the feasibility study is favorable, we do not
intend to wait for the completion of the demonstration plant in South
Africa to begin the licensing process to build a number of PBMRs in
this country. We will submit a license application for early site
permitting in 2002, followed by an application for a combined
construction and operating license after the necessary detailed design
is completed in South Africa in 2002.
conclusion
In conclusion, as the shortage of electricity supplies in several
areas of the country looms large and as our society places an ever-
increasing importance on cleaner air, we must find ways to preserve and
enhance the nuclear option as a component of the national energy
supply. This is an issue of urgent national priority.
Nuclear power has earned the right to be counted among this
country's most viable options as a future power source. It has achieved
an outstanding safety record and serves as a stable, economic and
abundant domestic source of electricity that emits no air pollutants or
greenhouse gases associated with fossil-fired plants.
Thank you for giving me the opportunity to share Exelon's
perspectives on the state of the nuclear industry, including the
importance of a stable and predictable nuclear regulatory environment,
and the important role that nuclear power can play.
______
Responses by Oliver D. Kingsley, Jr., to Additional Questions
from Senator Reid
Question 1. Has the industry completed an economic assessment of
this pebble bed type of reactor? What are the projected costs?
Response. The preliminary design of the Pebble Bed Modular Reactor
(PBMR) has just been completed in South Africa and the project team is
finalizing cost estimates to build the demonstration plant in South
Africa. As a project investor, Exelon is now beginning its own internal
assessment of the South African cost estimate. The assessment will
include a review of the project estimate and an adjustment of the
estimate to take into account differences in material and labor costs,
productivity rates, and construction techniques. We do not expect to
complete our assessment of the PBMR costs for construction and
licensing here in the United States until later this year.
Question 2. As you know, the industry--perhaps more than any other
industry--has a track record of significantly underestimating the cost
of building nuclear power plants by billions of dollars at a time. Why
should we believe this design will be any different, considering, in
particular, how novel this type of plant is?
Response. The predecessor companies of Exelon experienced first
hand the large cost overruns of building nuclear plants. There were
several contributors to those cost overruns:
A. Continuing changes in regulatory requirements as a result of the
Three Mile Island accident required that plants which were already
designed and under construction be redesigned and retrofitted to meet
new requirements in order to be licensed. These changes resulted in
both additional costs in design and construction work, as well as added
costs due to delays.
B. Very high interest rates were prevalent during that period.
These high interest charges were added to the cost of the plants and
often totaled several billion dollars.
C. The U.S. nuclear industry, unlike the French, did not adopt
standard plant designs. That added costs.
We have learned many lessons since that period. All of the
regulatory requirements will be defined and known before we start
construction as the result of the licensing process we will follow
under 10 CFR Part 52. Our exposure to interest rates will be
substantially reduced due to the significantly shorter construction
schedule for the PBMR. The industry's improved project management and
the modularity of the PBMR design will streamline construction. The
U.S. industry will reap the benefit of the South African pilot as well
as previous German experience with the reactor type. Finally, these
plants will be built and operated as ``merchant'' plants, not included
in any regulated rate base. The risk of cost overruns will be factored
into the decision of the investors who would provide the funding to
build these plants.
Question 3. A 1998 MIT study of new reactor designs concluded that
a 1000-megawatt pebble bed modular reactor would cost approximately $2
billion. With those kinds of costs, do you think a new pebble bed
reactor will be able to compete economically without significant
government subsidy?
Response. We have not reviewed the MIT study that you reference,
but the PBMR design which is being developed and which Exelon is
considering is considerably smaller and less expensive than the 1000-
megawatt reactor cited in the question. Government subsidization is not
being considered. Exelon's decision to proceed as an investor and as a
potential operator of the PBMR will be based on our economic analysis
that assumes no significant government subsidization.
__________
Statement of Gary L. Jones, Director, Natural Resources and
Environment, U.S. General Accounting Office
Mr. Chairman and members of the subcommittee: We are pleased to be
here today to discuss the challenges that the Nuclear Regulatory
Commission (NRC) faces as it moves from its traditional regulatory
approach, which was largely developed without the benefit of
quantitative estimates of risk, to a risk-informed, performance-based
approach. Under this approach, NRC will use risk assessment findings,
engineering analysis, and performance history to focus attention on the
most important safety-related activities, establish objective criteria
to evaluate performance, develop measures to assess licensee
performance, and focus on results as the primary basis for making
regulatory decisions.
NRC is responsible for ensuring that those who use radioactive
material--in generating electricity, for experiments in universities,
and for such medical uses as treating cancer--do so in a manner that
protects the public, the environment, and workers. NRC has issued
licenses to 103 operating commercial nuclear power plants and 10
facilities that produce fuel for these plants. In addition, NRC, or the
32 States that have agreements with NRC, regulate almost 21,000
entities that use nuclear materials (nuclear material licensees).\1\ In
the medical field alone, licensees annually perform an estimated 10 to
12 million diagnostic and therapeutic procedures involving radioactive
material.
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\1\ Currently, NRC has agreements with 32 States that they, rather
than NRC, regulate such entities as universities and hospitals that
handle nuclear material.
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Our testimony discusses the challenges that NRC faces to (1)
implement a risk-informed regulatory approach for commercial nuclear
power plants, (2) overcome the inherent difficulties in applying a
risk-informed regulatory approach to nuclear material licensees, (3)
ensure that the public is confident that safety will be maintained
under NRC's risk-informed approach, and (4) hire and retain staff. NRC
is aware of the complexities involved and the long-term nature of these
types of challenges and has initiated a number of activities to address
them. Its performance in addressing them will significantly shape its
ability to ensure that commercial nuclear power plants and other
licensees operate safely and ultimately that workers, the public, and
the environment are adequately protected.
In summary, we found the following:
<bullet> NRC's implementation of a risk-informed approach for
commercial nuclear power plants is a complex, multiyear undertaking
that requires basic changes to the regulations and processes it uses to
ensure the safe operation of these plants. NRC faces a number of
challenges to develop and implement this new approach. For example,
just developing a ``roadmap'' to guide the agency through this complex
process is a challenge. We recommended such a ``roadmap'' in March
1999. We suggested that a clearly defined strategy that would describe
the regulatory activities NRC planned to change to a risk-informed
approach, the actions needed to accomplish this transformation, and the
schedule and resources needed to make these changes would help guide
the regulatory transformation. While NRC developed the Risk-Informed
Regulation Implementation Plan to address our recommendation, we
believe the plan could be more comprehensive to cover such areas as
activities that cut across the agency, resources, performance measures,
or how various activities are interrelated.
<bullet> NRC needs to overcome a number of inherent difficulties as
it seeks to apply a risk-informed regulatory approach to nuclear
material licensees. Of most importance, the sheer number of licensees--
almost 21,000--and the diversity of activities they conduct--converting
uranium, transporting radioactive material, and using radioactive
material for industrial, medical, or academic purposes increase the
complexity of developing a risk-informed regulatory approach for
material licensees. In addition, NRC will be challenged to define its
role as an increasing number of States assume responsibility for
regulating nuclear material users within their borders. The decisions
that NRC ultimately makes on these fronts could have budgetary and
other implications for the agency.
<bullet> Another challenge for NRC will be to demonstrate that it
is meeting one of its performance goals under the Government
Performance and Results Act--increasing public confidence in NRC as an
effective regulator. This is because NRC has not defined the ``public''
that it is targeting and does not have a baseline by which to measure
the ``increase.'' To address this performance goal, NRC instituted an
18-month pilot effort to use feedback forms at the conclusion of public
meetings. The feedback forms will provide information on the extent
that the public was aware of the meeting and the clarity, completeness,
and thoroughness of the information that NRC provided at the meetings.
It is not clear, however, how NRC will use this type of information to
demonstrate that public confidence in NRC as a regulator has increased.
<bullet> Like other Federal agencies, NRC faces challenges in human
capital management, such as replacing a large percentage of its
technical staff and senior managers who are eligible to retire. The
loss of its staff is compounded by the tight labor market for
experienced professionals, the workload projected by the industry to
extend the operating licenses of existing plants and transfer the
ownership of others, and the declining university enrollment in nuclear
engineering studies and other fields related to nuclear safety. NRC has
developed a 5-year plan to identify and maintain the core competencies
it needs and has identified legislative options, such as allowing the
rehire of retired staff without jeopardizing their pension payments, to
help resolve its aging staff issue. To assess how existing human
capital approaches support an agency's mission, goals, and other
organizational needs, we developed a human capital framework, which
identified a number of elements and underlying values that are common
to high-performing organizations.\2\ NRC's 5-year plan generally
includes the human capital elements that we suggested.
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\2\ Human Capital: A Self-Assessment Checklist for Agency Leaders
(AO/OCG-14G, Sept. 2000).
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nrc faces challenges to implement a risk-informed regulatory approach
for commercial nuclear power plants
NRC's implementation of a risk-informed, performance-based
regulatory approach for commercial nuclear power plants is complex and
will require many years to fully implement. It requires basic changes
to the regulations and NRC's processes to ensure the safe operation of
these plants. NRC faces a number of challenges to develop and to
implement this process. For example, because of the complexity of this
change, the agency needs a strategy to guide its development and
implementation. We recommended such a strategy in March 1999. We
suggested that a clearly defined strategy would help guide the
regulatory transformation if it described the regulatory activities NRC
planned to change to a risk-informed approach, the actions needed to
accomplish this transformation, and the schedule and resources needed
to make these changes.\3\ NRC initially agreed that it needed a
comprehensive strategy, but it has not developed one. As one NRC
Commissioner said in March 2000, ``We really are . . . inventing this
as we go along [and] given how much things are changing, it's very hard
to plan even 4 months from now, let alone years from now.'' NRC did
develop the Risk-Informed Regulation Implementation Plan, which
includes guidelines to identify, set priorities for, and implement
risk-informed changes to regulatory processes. The plan also identifies
specific tasks and projected milestones.
---------------------------------------------------------------------------
\3\ Nuclear Regulation: Strategy Needed to Regulate Safety Using
Information on Risk (GAO/RCED-99-95, Mar. 19, 1999).
---------------------------------------------------------------------------
The Risk-Informed Regulation Implementation Plan is not as
comprehensive as it needs to be, because it does not identify
performance measures, the items that are critical to achieving its
objectives, activities that cut across its major offices, resources, or
the relationships among the more than 40 separate activities (25 of
which pertain to nuclear plants). For example, risk-informing NRC's
regulations will be a formidable task because they are interrelated.
Amending one regulation can potentially affect other regulations
governing other aspects of nuclear plant operations. NRC found this to
be the case when it identified over 20 regulations that would need to
be made consistent as it developed a risk-informed approach for one
regulation. NRC expects that its efforts to change its regulations
applicable to nuclear power plants to focus more on relative risk will
take 5 to 8 years.
NRC has compounded the complexity of moving to a new regulatory
approach by deciding that compliance with such an approach will be
voluntary. As a result, NRC will be regulating with two different
systems--one for those utilities that choose to comply with a risk-
informed approach and another for those that choose to stay with the
existing regulatory approach. It is not clear how this dual system will
be implemented.
One part of the new risk-informed approach that has been
implemented is a new safety oversight process for nuclear power plants.
It was implemented in April 2000; and since then, NRC's challenge has
been to demonstrate that the new approach meets its goal of maintaining
the same level of safety as the old approach, while being more
predictable and consistent. The nuclear industry, States, public
interest groups, and NRC staff have raised questions about various
aspects of the process. For example, the industry has expressed concern
about some of the performance indicators selected. Some NRC staff are
concerned that the process does not track all inspections issues and
NRC will not have the information available, should the public later
demand accountability from the agency. Furthermore, it is very
difficult under the new process to assess those activities that cut
across all aspects of plant operations--problem identification and
resolution, human performance, and safety conscious work environment.
In June 2001, NRC staff expect to report to the Commission on the first
year of implementation of the new process and recommend changes, where
warranted.
nrc needs to overcome inherent difficulties to apply a risk-informed
approach to nuclear material licensees
NRC is facing a number of difficulties inherent in applying a risk-
informed regulatory approach for nuclear material licensees. The sheer
number of licensees--almost 21,000--and the diversity of the activities
they conduct--converting uranium, decommissioning nuclear plants,
transporting radioactive materials, and using radioactive material for
industrial, medical, or academic purposes--increase the complexity of
developing a risk-informed approach that would adequately cover all
types of licensees. For example, the diversity of licensees results in
varying levels of analytical sophistication; different experience in
using risk-informed methods, such as risk assessments and other
methods; and uneven knowledge about the analytical methods that would
be useful to them. Because material licensees will be using different
risk-informed methods, NRC has grouped them by the type of material
used and the regulatory requirements for that material. For example,
licensees that manufacture casks to store spent reactor fuel could be
required to use formal analytical methods, such as a risk assessment.
Other licensees, such as those that use nuclear material in industrial
and medical applications, would not be expected to conduct risk
assessments. In these cases, NRC staff said that they would use other
methods to determine those aspects of the licensees' operations that
have significant risk, using an approach that considers the hazards
(type, form, and quantity of material) and the barriers or physical and
administrative controls that prevent or reduce exposure to these
hazards.
Another challenge associated with applying a risk-informed approach
to material licensees is how NRC will implement a new risk-informed
safety and safeguards oversight process for fuel cycle facilities.
Unlike commercial nuclear power plants, which have a number of design
similarities, most of the 10 facilities that prepare fuel for nuclear
reactors perform separate and unique functions. For example, one
facility converts uranium to a gas for use in the enrichment process,
two facilities enrich or increase the amount of uranium-235 in the gas,
and five facilities fabricate the uranium into fuel for commercial
nuclear power plants. These facilities possess large quantities of
materials that are potentially hazardous (i.e., explosive, radioactive,
toxic, and/or combustible) to workers. The facilities' diverse
activities makes it particularly challenging for NRC to design a ``one-
size-fits-all'' safety oversight process and to develop indicators and
thresholds of performance. In its recently proposed new risk-informed
safety oversight process for material licensees, NRC has yet to resolve
such issues as the structure of the problem identification, resolution,
and corrective action program; the mechanics of the risk-significance
determination process; and the regulatory responses that NRC would take
when changes in performance occur. NRC had planned to pilot test the
new fuel cycle facility safety oversight process in fiscal year 2001,
but staff told us that this schedule could slip.
NRC also faces challenges in redefining its role in a changing
regulatory environment. As the number of agreement States increases
beyond the existing 32, NRC must continue to ensure the adequacy and
consistency of the States' programs as well as its own effectiveness
and efficiency in overseeing licensees that are not regulated by the
agreement States. NRC has been working with the Conference of Radiation
Control Program Directors (primarily State officials) and the
Organization of Agreement States to address these challenges. However,
NRC has yet to address the following questions: (1) Would NRC continue
to need staff in all four of its regional offices as the number of
agreement States increases?; (2) What are the appropriate number, type,
and skills for headquarters staff?; and (3) What should NRC's role be
in the future? Later this month, a NRC/State working group expects to
provide the Commission with its recommended options for the materials
program of the future. NRC wants to be in a position to plan for needed
changes because in 2003, it anticipates that 35 States will have
agreements with NRC and that the States will oversee more than 85
percent of all material licensees.
nrc faces challenges in demonstrating increased levels of public
confidence--one of its goals under the government performance and
results act
Another challenge NRC faces is to demonstrate that it is meeting
one of its performance goals under the Government Performance and
Results Act--increasing public confidence in NRC as an effective
regulator. \4\ There are three reasons why this will be difficult.
First, to ensure its independence, NRC cannot promote nuclear power,
and it must walk a fine line when communicating with the public.
Second, NRC has not defined the ``public'' that it wants to target in
achieving this goal. Third, NRC has not established a baseline to
measure the ``increase'' in its performance goal. In March 2000, the
Commission rejected a staff proposal to conduct a survey to establish a
baseline. Instead, in October 2000, NRC began an 18-month pilot effort
to use feedback forms at the conclusion of public meetings. Twice a
year, NRC expects to evaluate the information received on the forms to
enhance its public outreach efforts. The feedback forms that NRC
currently plans to use will provide information on the extent to which
the public was aware of the meeting and the clarity, completeness, and
thoroughness of the information provided by NRC at the meetings. Over
time, the information from the forms may show that the public better
understands the issues of concern or interest for a particular plant.
It is not clear, however, how this information will show that public
confidence in NRC as a regulator has increased. This performance
measure is particularly important to bolster public confidence as the
industry decides whether to submit a license application for one or
more new nuclear power plants. The public has a long history with the
traditional regulatory approach and may not fully understand the
reasons for implementing a risk-informed approach and the relationship
of that approach to maintaining plant safety.
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\4\ NRC's four performance goals are to maintain safety, increase
public confidence, reduce unnecessary regulatory burden, and enhance
the effectiveness and efficiency of its activities and decisions.
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nrc faces human capital difficulties
In a highly technical and complex industry, NRC is facing the loss
of a significant percentage of its senior managers and technical staff.
For example, in fiscal year 2001, about 16 percent of NRC staff are
eligible to retire, and by the end of fiscal year 2005, about 33
percent will be eligible. The problem is more acute at the individual
office level. For example, within the Office of Nuclear Reactor
Regulation, about 42 percent of the technical staff and 77 percent of
senior executive service staff are eligible for retirement.\5\ During
this period of potentially very high attrition, NRC will need to rely
on that staff to address the nuclear industry's increasing demands to
extend the operating licenses of existing plants and transfer the
ownership of others. Likewise, in the Office of Nuclear Regulatory
Research, 49 percent of the staff are eligible to retire at the same
time that the nuclear industry is considering building new plants.
Since that office plays a key role in reviewing any new plants, if that
office looses some of its highly skilled, well-recognized research
specialists to retirement, NRC will be challenged to make decisions
about new plants in a timely way, particularly if the plant is an
untested design.
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\5\ The Office of Nuclear Reactor Regulation is responsible for
ensuring that commercial nuclear power plants operate safely and do not
endanger the public or the environment.
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In its fiscal year 2000 performance plan, NRC identified the need
to maintain core competencies and staff as an issue that could affect
its ability to achieve its performance goals. NRC noted that
maintaining the correct balance of knowledge, skills, and abilities is
critical to accomplishing its mission and is affected by various
factors. These factors include the tight labor market for experienced
professionals, the workload as projected by the nuclear industry to
transfer and extend the licenses of existing plants, and the declining
university enrollment in nuclear engineering studies and other fields
related to nuclear safety. In October 2000, NRC's Chairman requested
the staff to develop a plan to assess the scientific, engineering, and
technical core competencies that NRC needs and propose specific
strategies to ensure that the agency maintains that competency. The
Chairman noted that maintaining technical competency may be the biggest
challenge confronting NRC.
In January 2001, NRC staff provided a suggested action plan for
maintaining core competencies to the Commission. The staff proposed to
begin the 5-year effort in February 2001 at an estimated cost of $2.4
million, including the costs to purchase software that will be used to
identify the knowledge and skills needed by NRC. To assess how existing
human capital approaches support an agency's mission, goals, and other
organizational needs, we developed a human capital framework, which
identified a number of elements and underlying values that are common
to high-performing organizations. NRC's 5-year plan appears to
generally include the human capital elements that we suggested. In this
regard, NRC has taken the initiative and identified options to attract
new employees with critical skills, developed training programs to
meets its changing needs, and identified legislative options to help
resolve its aging staff issue. The options include allowing NRC to
rehire retired staff without jeopardizing their pension payments and to
provide salaries comparable to those paid in the private sector. In
addition, for nuclear reactor and nuclear material safety, NRC expects
to implement an intern program in fiscal year 2002 to attract and
retain individuals with scientific, engineering, and other technical
competencies. It has established a tuition assistance program,
relocation bonuses, and other inducements to encourage qualified
individuals not only to accept but also to continue their employment
with the agency. NRC staff say that the agency is doing the best that
it can with the tools available to hire and retain staff. Continued
oversight of NRC's multiyear effort is needed to ensure that it is
being properly implemented and is effective in achieving its goals.
Mr. Chairman and members of the subcommittee, this concludes our
statement. We would be pleased to respond to any questions you may
have.
__________
Statement of Steven M. Fetter, Managing Director, Global Power Group
Fitch, Inc.
I appreciate the opportunity to return to the Subcommittee on Clean
Air, Wetlands, Private Property and Nuclear Safety to continue
discussions about the appropriate role for the Nuclear Regulatory
Commission (NRC) in the evolving utility competitive environment. Fitch
is the international credit rating agency that resulted from mergers
among three rating agencies: the New York-based Fitch Investors
Service, the London-based IBCA Limited, and the Chicago-based Duff &
Phelps. I will speak from the perspective of a member of the financial
community as well as former Chairman of the Michigan Public Service
Commission. I also note that I am not a nuclear engineering or nuclear
physics expert, and in this regard I am representative of the large
majority of investors and financial analysts who play some role in
assessing the nuclear industry.
The manner in which the NRC carries out its responsibilities during
the electric industry's transition to competition will have a profound
impact as to the role nuclear power will play within the restructured
utility environment. As I have testified before, the NRC is at the
center of investors' perceptions of the financial risks facing the U.S.
nuclear industry. In evaluating utilities that operate nuclear plants,
debt and equity investors study closely the processes and actions of
the NRC. To the extent that these regulatory responsibilities are
carried out in a consistent and predictable manner, investors find
comfort with the outlook for both individual nuclear utilities and the
nuclear industry as a whole.
I am extremely encouraged by the actions of the NRC beginning soon
after the July 1998 NRC oversight hearing. Responding to this
subcommittee's encouragement and under the leadership of NRC Chairmen
Shirley Ann Jackson and later Richard Meserve, the NRC has welcomed
interested stakeholders into the formulation and implementation of a
reactor oversight process that focuses on objective assessment of
safety-related factors. Using clearer standards based upon individual
plant characteristics, the agency has been able to direct its attention
for maximum impact. Moreover, leaving the somewhat nebulous Systematic
Assessment of Licensee Performance (SALP) and Watch List behind, the
NRC has increased the transparency of its processes to both the
industry and the public through an NRC website that provides more
information than has ever been available before.
The NRC's initial experience with the processes of transferring and
renewing nuclear licenses bodes well for the future. The agency set
optimistic targets for both of these activities and then easily beat
their deadlines. If the NRC can continue this positive track record
when license renewal applications grow from a handful into double
digits, and further streamline its regulatory activities while not
compromising safety, it should secure the more than 20 percent of the
Nation's power supply that comes from nuclear energy. Down the road, it
is likely that the NRC will face even more important licensing issues
involving new nuclear plants, both pre-and-post construction. It
appears that the NRC will attempt to carry out its responsibilities in
this regard with the same level of sensitivity that it has shown on
reactor oversight and existing license transfers and renewals.
Testifying before the Senate Energy and Natural Resources Committee
last week, NRC Chairman Meserve concluded:
The Commission has long been, and will continue to be, active
in concentrating its staffs' efforts on ensuring the adequate
protection of public health and safety, the common defense and
security, and the environment in the application of nuclear
technology for civilian use. Those statutory mandates
notwithstanding, the Commission is mindful of the need to: (1)
Reduce unnecessary burdens, so as not to inappropriately
inhibit any renewed interest in nuclear power; (2) Maintain
open communications with all of its stakeholders, in order to
seek to ensure the full, fair, and timely consideration of
issues that are brought to our attention; and (3) Continue to
encourage its highly qualified staff to strive for increased
efficiency and effectiveness, both internally and in our
dealings with all of the Commission's stakeholders.
Chairman Meserve also called on the Congress to extend the Price-
Anderson Act, which establishes a framework that provides assurance
that adequate funds are available in the event of a nuclear accident,
beyond its August 1, 2002 expiration. Without the framework provided by
the Act, private sector investment in nuclear power would be severely
chilled due to the potential risk of large liabilities. With NRC
leadership on record with messages like these, investors will be more
likely to support an expanded role for nuclear power.
For example, consider the significant change in perception since
the time of the first in this series of oversight hearings. In 1998,
the two most frequent topics upon which I was invited to speak were
``Is there a place for nuclear power in the evolving competitive
environment?'' and ``California's success in the evolution to electric
restructuring.'' Today, the concerns are the same but you can juxtapose
the words ``nuclear power'' and ``California.'' I have more confidence
that nuclear power will be an integral part of the restructured
environment than I am that California will soon remedy the flaws that
it built into the State's competitive framework.
Consistent with this bullish stance on the future of nuclear power
is the action Fitch took last week in rating Exelon Generation Company
LLC (ExGen), a newly formed non-regulated subsidiary of Exelon, the
holding company created by the merger of Unicom Corporation and PECO
Energy Company (see Attachment One: Fitch Press Release dated May 2,
2001). Fitch assigned an implied ``BBB+'' rating to the senior
unsecured debt obligations of ExGen--a respectable investment-grade
rating--notwithstanding the company's ownership and operation of 19
nuclear plants at 11 locations.
Fitch found that ExGen's significant nuclear exposure is mitigated
by the diversity of the nuclear asset fleet, an excellent record as a
nuclear operator, the sourcing and marketing capability of its trading
operations, and adequate liquidity. Far from representing a financial
drag on a utility entering the competitive landscape, ExGen's well-
conceived emphasis on nuclear energy, accompanied as it is by excellent
plant condition, strong operational performance, and adequate
decommissioning funding, seems to offer a competitive advantage.
Similarly, Fitch rated PSEG Power LLC's (PSEG Power) initial
offering of $1.8 billion of senior unsecured debt ``BBB+,'' despite its
primarily merchant character after July 2002 and significant reliance
on nuclear generation (63 percent in 2001 declining to 43 percent in
2005) (see Attachment Two: Fitch Press Release dated March 26, 2001).
PSEG Power's rating was favorably impacted by its location and
participation in the Pennsylvania-New Jersey-Maryland (PJM) power grid,
which facilitates a large and liquid energy market.
There is much to support an expanding role for nuclear generation
some time in the future. Nuclear's air quality benefits cannot be
matched by fossil-fueled plants and nuclear fuel is not subject to the
degree of volatility we have recently seen in natural gas prices in the
western half of the United States. That all said, the elephant in the
corner is disposal of spent nuclear fuel. Progress on choosing and
developing a permanent site for the disposal of spent fuel is a
necessity. Before we see progress on planning for the construction of a
new generation of nuclear plants, the waste issue must be resolved. Any
delay in achieving this goal likewise delays the ability of the nuclear
industry to assist in the country's future electricity needs.
______
Attachment One: Fitch Press Release on Exelon Generation Company LLC
fitch upgrades exelon & peco; rates exelon generation co. ``bbb+''
Fitch today upgraded the senior unsecured debt of Exelon
Corporation (Exelon) to ``BBB+'' from ``BBB'' and upgraded the senior
secured debt of PECO Energy Company (PECO) to ``A'' from ``A-.''
Simultaneously, Fitch assigned an implied ``BBB+'' rating to the senior
unsecured debt obligations of Exelon Generation Company LLC (ExGen), a
newly formed non-regulated subsidiary. Fitch also affirmed the senior
secured rating of Commonwealth Edison Company (ComEd) at ``A-.'' The
Rating Outlook for Exelon and all of its subsidiaries is Stable. A
complete recap of Fitch's rating action with respect to Exelon and its
subsidiaries is shown below.
The upgrade of Exelon primarily reflects the holding company's
strong consolidated credit measures, the predictable cash-flow of its
regulated distribution subsidiaries (PECO and ComEd), the availability
of unrestricted dividend payments from its three core operating
subsidiaries, the scale and diversity of its generation subsidiary
(ExGen) and the contractual commitments between ExGen and the regulated
distribution companies. The contractual arrangements between the
subsidiaries substantially reduce consolidated business risk. The
credit profile of Exelon and its subsidiaries is further strengthened
by management's commitment to issue equity as may be needed to maintain
a capital structure that is appropriate for the credit ratings. The
company's significant nuclear exposure is mitigated by the diversity of
the nuclear asset fleet, an excellent record as a nuclear operator, the
sourcing and marketing capability of its trading operations and
adequate liquidity.
The ratings upgrade of PECO and the affirmation of ComEd reflect
the strength of the companies' actual and projected financial results
and the absence of commodity price exposure. Both entities have entered
into full requirements supply contracts with ExGen covering each
company's provider of last resort (PLR) obligation. PECO's PLR
obligation extends through 2010 and ComEd's through 2004. Both utility
subsidiaries have implemented restructuring plans that resolved
stranded cost concerns and insure a steady revenue stream from the
regulated transmission and distribution businesses.
The ``BBB+'' rating of ExGen's senior unsecured obligations
recognizes the scale and geographic diversity of the generation
portfolio, the all-requirements sales agreements with PECO and ComEd
that assure a predictable revenue stream for the term of the contracts,
modest leverage and strong financial projections. Moreover, ExGen has a
very competitive cost structure that is well positioned to produce
consistent cash-flow when operating on a merchant basis. Since a
majority of the portfolio is base load nuclear capacity, it is expected
to achieve a high level of dispatch in most price scenarios. The
significant nuclear exposure is mitigated by the diversity of the
portfolio, with 19 units at 11 nuclear stations. According to the
independent engineer Sargent and Lundy LLC (S&L), the nuclear units are
in excellent condition and improving in operational performance.
Decommissioning funding provisions are adequate and long-term waste
fuel storage at each site has been addressed, either through the
inclusion of dry cask storage costs or re-racking of the spent fuel
pools.
The power marketing and trading activity, Power Team, is closely
linked to, and supports, the generation assets. The Power Team markets
physical capacity and does not act as a market maker, thereby limiting
its risk exposure. By maintaining a net positive supply position, ExGen
is able to limit operational risk. Power Team also benefits from a
sizable amount of contractual transmission capacity. Risk management
policies appear to be prudent.
ExGen's capital structure begins with a modest 35 percent debt
ratio, growing to about 43 percent in 2003 (excluding non-recourse
project finance debt). Due to the low amount of financial leverage,
ExGen is expected to produce interest coverages (after capital
expenditures) of 4<greek-e>6 times (<greek-e>) in the next 10 years and
over 2.75 <greek-e> in a stress scenario.
Exelon is the holding company created by the merger of Unicom
Corporation and PECO. With the completion of the merger in October
2000, PECO and ComEd became distribution companies only; all power
generating assets and wholesale power marketing operations of PECO and
ComEd, along with other generating assets owned by Exelon, were
transferred to the newly created ExGen.
The following summarizes the rating actions announced today for
Exelon and its subsidiaries:
Exelon Corp.:
<bullet> Senior Unsecured Debt (implied) to ``BBB+'' from ``BBB'';
<bullet> Commercial Paper affirmed at ``F2.''
PECO Energy Company:
<bullet> First Mortgage Bonds to ``A'' from ``A-'';
<bullet> Senior Unsecured to ``A-'' from ``BBB+'';
<bullet> Pollution Control Revenue Bonds (non-collateralized) to
``A-'' from ``BBB+'';
<bullet> Preferred Stock to ``BBB+'' from ``BBB'';
<bullet> Trust Preferred Stock to ``BBB+'' from ``BBB'';
<bullet> Commercial Paper to ``F1'' from ``F2.''
Commonwealth Edison Company
<bullet> First Mortgage Bonds affirmed at ``A-'';
<bullet> Senior Unsecured affirmed at ``BBB+'';
<bullet> Pollution Control Revenue Bonds (noncollateralized)
affirmed at ``BBB+'';
<bullet> Preferred Stock affirmed at ``BBB'';
<bullet> Trust Preferred Stock affirmed at ``BBB'';
<bullet> Commercial Paper affirmed at ``F2.''
Exelon Generation Company:
<bullet> Senior Unsecured Debt (implied) assigned new rating of
``BBB+''.
______
Attachment Two: Fitch Press Release on PSEG Power LLC
fitch expects to rate pseg power llc sr unsecured debt ``bbb+''
Fitch expects to rate PSEG Power LLC's (Power) initial offering of
$1.6 billion of senior unsecured debt ``BBB+.'' Power is a wholly owned
subsidiary of Public Service Enterprise Group (PSEG) and the parent
holding company of PSEG's portfolio of non-regulated domestic electric
generation assets and energy trading organization. Power was formed in
July 1999 to acquire, own and operate the electric generation assets of
Public Service Electric and Gas Company (PSE&G). The Rating Outlook is
Stable.
The rating reflects the scale and diversity of PSEG Power's
generating portfolio, strong projected financial measures, competitive
cost structure, and the sound sourcing and marketing capability of its
energy trading and marketing organization. The company's overall risk
profile also benefits from its location and participation in the
Pennsylvania-New Jersey-Maryland (PJM) power grid, which is a large and
liquid energy market located in the populous Mid-Atlantic region of the
eastern U.S.
The credit rating also takes into consideration Power's primarily
merchant character after July 2002 when the company's off-take contract
with PSE&G expires, the potential for excessive new plant construction,
evolving environmental regulations, and nuclear operating risk. The
merchant risk is mitigated by the likelihood that Power will enter into
a new power contract with PSE&G and/or other PJM utilities after
expiration of its existing contract. Because of the scale and location
of Power's assets, the company is well positioned to serve PSE&G's
retail load, either directly or indirectly, well beyond the current
contract period. Market competition could become more of a concern as
Power expands its merchant facilities outside of PJM.
The high percentage of net cash-flow derived from coal and nuclear
units makes Power's fixed charge coverage sensitive to low gas prices.
Conversely, coverage ratios benefit from high gas prices. Future cash-
flows also are sensitive to excessive new plant construction. The
capacity over build stress case, produced the lowest fixed charge
coverage, falling below 2.5 times (<greek-e>) in 2001, but still
averaged a relatively healthy 4<greek-e> over the 10 year forecast
period. Combining the over build case with a 10 percent increase in
operating and maintenance expenses reduced the fixed charge coverage to
a below 2<greek-e> in 2001 and an average of 3.5<greek-e> over the
forecast period.
Power is pursuing a regional generation strategy focussed on the
super-region of PJM, New England, East Central Area Coordination
Agreement (ECAR), Virginia/Carolina and New York. Currently, 97 percent
of Power's capacity is located in PJM, consisting of the formerly
jurisdictional assets of PSE&G. The assets were transferred to Power in
August 2000 in exchange for a $2.8 billion note. Power also owns a
generating facility in New York (380 MW), is developing additional
projects in ECAR and PJM and eventually plans to expand its New York
facility.
The majority of Power's revenue will be derived from supplying
PSE&G's provider of last resort (PLR) load. A full requirements
contract extends to July 31, 2002. Thereafter, Power's goal is to bid
for 75 percent of the PLR load or enter into other contractual
arrangements.
Facilities under construction or in advanced development total
about 4,200 MW, including 1,854 MW in PJM, 2,000 MW in ECAR and 350 MW
in New York. All the new facilities are natural gas fired simple cycle
or combined cycle units and will increase the diversity of Power's
generation mix and mode of operation.
In 2001, the generation mix is projected at 63 percent nuclear, 31
percent coal, 6 percent gas/oil and 1 percent pumped storage. By 2005,
gas accounts for 38 percent of output, nuclear 43 percent, and coal 19
percent. Based on output, 93 percent of generation is currently base
load, 3 percent intermediate and 3 percent peaking. The mode of
operation changes in 2005 to 62 percent base load, 35 percent
intermediate and 3 percent peaking.
<greek-d>