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UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
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BRIEFING BY ORGANIZATION
OF AGREEMENT STATES
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PUBLIC MEETING
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U.S. Nuclear Regulatory Commission
One White Flint North
Rockville, Maryland
Monday, February 26, 1996
The Commission met, pursuant to notice, at 10:00
a.m., the Honorable Shirley A. Jackson, chairman, presiding.
COMMISSIONERS PRESENT:
SHIRLEY A. JACKSON, CHAIRMAN
KENNETH C. ROGERS, COMMISSIONER
GRETA J. DICUS, COMMISSIONER
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NRC STAFF PRESENT:
MARTIN MALSCH, Deputy General Counsel
JOHN C. HOYLE, Secretary
REPRESENTING THE ORGANIZATION OF AGREEMENT STATES:
TERRY STRONG, Chairman
BOB QUILLIN, Chairman-Elect
RICHARD RATLIFF, Past Chairman
TOM HILL, Secretary
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P R O C E E D I N G S
[10:00 a.m.]
CHAIRMAN JACKSON: Good morning, ladies and
gentlemen. This morning I would like to welcome
representatives from the Organization of Agreement States --
Mr. Hill, Mr. Ratliff, Mr. Strong and Mr. Quillin -- who
will be briefing the Commission on some of the more
significant issues confronting the Agreement States today.
Today's briefing by the Organization of Agreement
States is important to the Commission for several reasons.
Nearly three-quarters of the materials licensees, about
15,000 in this country, are regulated by 29 Agreement
States. The size of this program makes it critical that the
NRC and the Agreement States work effectively and
efficiently to ensure that public health and safety are
adequately protected. Only through cooperative efforts of
both organizations will this program continue to succeed.
Today the Commission looks forward to hearing from
you on your views on the status of the program, but before
we begin I would like to note that this is the first public
Commission meeting for our newest Commissioner, Commissioner
Greta Dicus. I'd like to publicly introduce her, then.
I frankly find it quite fitting and indeed
comforting to have Commissioner Dicus at this particular
briefing, since she is a former chairman of the Organization
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of Agreement States. So Commissioner Dicus, welcome.
Commissioner Rogers, do you have anything you'd
like to add?
COMMISSIONER ROGERS: No, not at this time.
CHAIRMAN JACKSON: Commissioner Dicus, anything to
add?
COMMISSIONER DICUS: Not at this time.
CHAIRMAN JACKSON: If not, Mr. Strong, you may
proceed.
MR. STRONG: Good morning.
I have been in this business for a long time now
and have been a participant in the NRC Agreement States
relationship for a very long time. I want to start with
this issue and I will come back to it at the end of my
remarks.
In my dealings in environmental health, broadly in
environmental health in the State of Washington, the
Agreement State program is probably the best example of
state and federal relationships that exist in the government
today. There are observers that point to this as the best
example, as the way programs can run, should run. It's an
outstanding example of the states and the federal government
working together on the same kinds of programs. We have the
same assignment in terms of radioactive materials.
It's just an outstanding program, and there are
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several things that I want to look at specifically that are
examples maybe of -- I don't want to say inattention, but
it's like a marriage; the relationship needs to be worked
at. It needs to be groomed and taken care of and nurtured
on a continuing basis. There are several examples, several
things that I want to address as examples maybe of where we
can take better care of it.
There are two recent examples of doing business as
usual -- adopting rules, because that's usually the way we
do things; that's how we address these things. The example
of the Nuclear Regulatory Commission adopting a rule that is
intended to prevent the intentional exposure from the use of
radioactive materials.
I don't know that the states and the Nuclear
Regulatory Commission talked about that rule, about what we
could do, maybe other than adopting a rule, that would have
been just as effective, and the states didn't get involved
in that. I don't know if we had gotten involved in it that
something else might have been the result, but the NRC
proceeded to adopt that rule.
There's -- you'll hear more about it as we go
on -- the QM rule in regulating the uses of radioisotopes in
medicine. The federal government and the states talked back
and forth for a long time about that rule. And I don't want
to imply that the states always know what is the right --
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CHAIRMAN JACKSON: Which rule are you referring to
here, the one that you're saying that the states and the NRC
talk back and forth about.
MR. STRONG: The QM rule?
CHAIRMAN JACKSON: Is that the one we're --
MR. STRONG: Yes. I think that our advice was,
"Don't do that. We don't think that's the right thing to
do. We would hope that you wouldn't do that. Don't do
that." And it got done anyway and now I think -- and the
states, many of the states have adopted the same rule, and
it doesn't work very well.
I'm not sure what we could have done together in
advance that might have prevented that except that we all
proceeded down the road kind of independently and it
didn't -- I don't think it's worked out just right for all
of us.
CHAIRMAN JACKSON: Can you give a little more
specificity to that by giving me one or two what you feel to
be particular vulnerabilities or negatives?
MR. STRONG: Can I come back?
CHAIRMAN JACKSON: Sure.
MR. STRONG: Can I come back at the end? Okay.
We talked about that but we didn't connect, on the
discussions, on the advice that we were working with.
Let me change gears to the Department of Energy.
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There's been a number of reports. There's been a number of
initiatives that have gone on involving the Department of
Energy and the regulation of radioactive materials that are
used by the Department of Energy and their privatization
initiatives that they have dealt with.
Our sense of it is that the Nuclear Regulatory
Commission is really not enthusiastic, is maybe not able at
this point to regulate the uses of radioactive materials
that are used by the Department of Energy.
The states probably don't have the resources,
either, but the states are there. In my case, in the State
of Washington, I deal directly with the Department of Energy
on the Hanford Reservation all the time. There are
discussions going on right now that would allow the State of
Washington radiation protection program to regulate the uses
of radioactive materials on the Hanford Reservation. They
seem interested in that. We're interested in that.
I guess that I want to -- I don't want to go away
from or get out in front of the Nuclear Regulatory
Commission on that issue. I want to make sure that we
connect, that the discussions are complete and thorough and
that we do this together. We have a common assignment, to
regulate the uses of radioactive materials.
There's another initiative that you have that
affects the relationship between your organization and our
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organizations. Your strategic initiative rebaselining
activity is going to address a lot of these things, and I
would hope as that goes forward, there are certain key
issues I know you have been involved in -- the Commission
has. The issue of training and travel funding for the
states -- that's a real hot button for us, that as your
strategic assessment looks at the relationship between you
and us, that that gets taken care of, examined so that
hopefully we can all be happy with that issue, as it would
end up.
The IMPEP program, the evaluation of our programs
and your regional programs as radioactive materials are
regulated -- I think that is on the positive side. I think
we are working together on that program, and I think that we
dare not disconnect on that. It's not done. We need to
make sure that that is done properly.
CHAIRMAN JACKSON: Do you have any thoughts about
the effectiveness of the program to date?
MR. STRONG: Well, it's new. After the pilot
activities, you've done one program. And I think my
conversations with North Carolina and the people who
participated in that program, I think that -- well, it's
your first time out, our first time out in the program.
No, except that it's positive. What I hear is
that it's positive. That's going to work all right. It's
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an example of where we have gotten together and connected
and can make this thing work.
You're doing something else that I hope that we
could address, and that is the closest connection between
you and me, in the State of Washington, is the state liaison
officer, your person that is still in Walnut Creek. When he
retires, when he leaves, the plan is not to replace him, not
to replace that position, and you would bring that FTE back
here to Washington. And Bob Doda's FTE will come back to
Washington.
My ability to connect with you, to maintain the
relationship between us, when we have the same business --
we're in the same business together -- I can say that I wish
you wouldn't do that. I wish you wouldn't take that FTE
away, but I understand the necessity.
What I want to do is connect with you and talk
with you and make sure that we can all agree that that's the
best way to proceed with those FTEs. I'm really concerned
about the distance, simple things like time zone changes.
When I'm still working in my office at 5:00, you all are
gone home. At 8:00, I can't find you.
CHAIRMAN JACKSON: I'm here.
MR. STRONG: But I'm sure that you're not going to
give me your telephone number and I'm not going to call you
up. But there's somebody in the office at Walnut Creek at
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5:00, when it's still 5:00 my time, and that's what I'm
driving at.
I want to go back to what I started with. This
Agreement State program with the Nuclear Regulatory
Commission is the most outstanding program, after all my
years of experience, I'm looking at the other federal
agencies that we relate to and I don't want this to get
damaged. I don't want, because of neglect, because of our
failure to communicate properly, because something goes
wrong -- I want to stay connected and I want this to work.
And I guess that's the bottom line of my message.
I think that Richard is going to talk specifically
about a program where we do connect.
CHAIRMAN JACKSON: Why don't we walk through your
agenda, and then we'll come back. I have a number of
questions and comments for you.
MR. RATLIFF: As I've been here before, we've
talked about various issues, but one that I think affects
not all Agreement States but the majority of them is the
industrial radiography rules. I think over the years, in
the courses I went to as a new inspector, NRC really
instilled in all of us the fact that this was an area where
there was the gravest danger, that prior to Chernobyl there
were probably more radiation deaths from industrial
radiography than any other commercial use of radioactive
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material.
So we knew that there was a lot of problems. The
State of Texas worked with the Nuclear Regulatory Commission
in producing two documents -- "Working Safely in
Gammaradiography," another one that looked at all the
overexposures, and it was kind of a document to show
radiographers how their dumb mistakes can lead to real loss
of limb and serious radiation exposure.
And I think to that end, we all worked together to
really develop programs to try to stop these extremely high
exposures, primarily to young males who were normally what
they called at that time assistant radiographers. That
title meant that I may have been hired that morning and I
was now in charge of making radiographic exposures.
So I think the first step that worked well was the
NRC set up a steering committee and invited three of the
states. I was on the committee with Ronny Wascom from
Louisiana and Don Honey from California. And from NRC, Tony
Hsia chaired it and did a great job, because this was Tony's
first time to see radiography and we went to all of the
manufacturers and we went to field sites.
And what became clear through this meeting that we
all knew was if a radiographer used his or her survey meter
to check at the end of the exposure, there would be no
problem, but in reality, because of poor working conditions,
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the constant push by the foreman, especially on pipeline
jobs, to get moving, they didn't use their meter and then
they had problems with exposures.
The report that we issued, though, set up a
comprehensive program we felt would help this to improve the
training, which was definitely needed because when you have
a person out there who has never seen a radioactive source
and ends up picking it up and holding it in his hands,
you're looking at the worst possible situation.
So training was a real strong need, and a
verification of training through a testing program, and
improvement of equipment because we knew that many times,
the equipment would not work. You would crank a source out
and it would become disconnected. And even if you used some
of your best safety efforts, you still had exposures that
were unnecessary.
This document was submitted to the Commission in
'84. It was titled "Radiography Equipment Safety
Performance Criteria." And because we have so many
industrial radiographers in the Southwest, along the Gulf
Coast area, Texas decided and we applied for a grant from
NRC to do a pilot certification test.
And NRC funded this, about half of the funds for
this, and Texas went and developed a test that was monitored
and designed by a cyclometrician. I never knew was a
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cyclametrician was until then. But this person from the
University of Texas, she was able to show us that it's not
only the correct answer that's important on a test but you
have to make sure the wrong answers don't deceive people.
What we were able to do was develop a bank of 500
questions that we provided to NRC and then proceeded forward
to have additional questions that had been certified. So we
developed a whole bank of questions.
Based on the report that NRC had, Texas and
several other states went forward then and continued with
their rules. We actually put equipment standards in our
rules and went with a two-person radiographer crew. We felt
that if you had a -- all of our problems in Texas, Oklahoma,
Louisiana, had primarily been young, new assistant
radiographers with no training. We felt that if you
eliminated that problem, where you never had an assistant on
a job just with another radiographer, where they could get
in trouble, it would alleviate a lot of the problems.
And so we instituted that program and as it
developed, we started seeing a real improvement in the
performance of radiography companies. We eliminated, almost
within a two-year period, the number of burns. We were
seeing probably two to three burns, either on fingers or
hands. We had one person who was sterilized from the
radiation. We had really an early win.
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We saw another thing, too, that all of a sudden
these people, these industrial radiographers had pride.
They would complain that they went to the dentist and the
dental technician had to take three sets of films because
they didn't know how to develop them properly and why
shouldn't they be credentialed? And you actually saw a
change in this field. I think it was really positive and
really led me to believe that these people now understood
and if they saw a bare radioactive source, you would no
longer have them pick it up and hold it and result in a
major injury to themselves.
So one of the things that one of my former bosses
did at a national meeting, at Bailey, was talking about this
radiography, and he said the other side benefit is all the
bad radiographers go to the other states and NRC states now.
Well, it wasn't long after that that we had people
from all over the country sending their radiographers to
take the Texas test so they could say that they had passed
the test and they could get jobs in other states.
And since that point, Texas worked with the
Conference of Radiation Control Program Directors, and there
are now seven states -- one of them a non-Agreement State,
Oklahoma -- who actually use the Texas test. They broker it
through the conference and they're able to make sure that
these people who come on the job are trained.
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Since the initial testing program in '87 there's
been over 4,000 radiographers in Texas and 8,000 across the
United States who have taken this test and passed it.
We feel that we've come a long way. Part of our
rules, where we were changing the equipment standards, was
probably the hardest to implement because you had, at the
time, four major companies who made radiography equipment,
and they just couldn't meet those standards. And they would
come, they met with us many times, until now, as you're
aware, finally the new radiography equipment standards are
now finalized in NRC's rules and we all see, I think, a real
positive outcome.
All of us, as regulators, though, and our people
should have seen it even more so, since we have so many
radiographers, didn't comprehend all the things in the rule
that would happen. One of them was that the gamma
pipeliners, which is a device that's just put on the
pipeline -- it doesn't have a source crank out -- doesn't
meet the new standards. So we have a lot of companies that
use pipeliners that really, because of radiation exposure
limits in the new rules, can't use them, and the fact that
there's only one company with cobalt-60 units that's
authorized to sell them.
So we're working with those licensees on a case by
case basis. In fact, we've had good working relationships
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with NRC on this. I don't think any of us realize that the
airlines, when they radiograph airplane engines, have a
special need where their end of their guide tube can't meet
the ANSI standard because you have a thin tube that goes
into the engine. But in fact, it's locked in place and it's
tested before you crank the source out.
So we didn't want to shut the airlines down or not
have their engines radiographed, because we have to fly to
these meetings. And I think it's worked well. That's been
a good area.
The area where I think we've had a problem in the
recent times is the two-person crew. We feel real strong,
in the southern states that have a lot of radiographers,
that you really need two people there, and in Texas we feel
it needs to be two radiographers, to make sure that
operations are conducted safely, and the reason being that
you're using many times 200 Curie of radioactive sources.
And with these large sources, you're really at a potential
for a real public health threat is they're not properly
used.
I think NRC had a good process of getting input on
their Part 34, going to industry, to the states, and I would
have to say it's probably the best participatory rulemaking
I've seen amongst NRC and the states.
The only problem we had is when it finally came
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out, the two-person crew was eliminated, even though the
industry people doing field radiography supported it, the
states supported it, and some of NRC supported it. And I
feel that's an area that we really do a disservice on
temporary job site radiography by not having two-person
crews.
The current NRC rule will be coming forward to
you, I think, and I appeal that you take a real close look
at that and work with the states because we really feel
strongly that without two persons being required, you'll run
into a situation where you could have a grave threat to
public health develop if there's an accidental situation.
We feel that the proposed language that we last
saw, where you would post signs to warn people to keep out
of this area because it could be a potentially dangerous
area just doesn't cut it for public health and safety.
We feel that the certification process that you
have adopted, though, is going to work well, and we're
hoping -- you know, one of the resolutions that I sent to
you after we had our Agreement States meeting was to set up
a group, and I think Terry is working on that, where the NRC
and the Agreement States and the Conference of Radiation
Control can work together because once we have multiple
certification programs, what we're going to have to do is
make sure that we recognize them under reciprocity, or else
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the whole program becomes bureaucratic, and we really don't
help safety.
And so to that end, the Conference of Radiation
Control Program Directors is going to approve and set up a
1996 training session for radiographers for regulators in
Houston, Texas, and we feel this will get everybody together
to work out the problems, if there are any problems, on
reciprocity, on what is the minimum training course required
before you can take a radiography certification test, and we
feel one of the more important things, how much on-the-job
training must you have before you can actually take that
test and become a radiographer.
I think that this is an area, and Chairman
Jackson, this has been, I think, a good example of us
working together. We spent many hours, we've looked at
technical issues, we've looked at the issues of economics,
and I feel that we're at a point now where we can eliminate
all the overexposures if we just follow through with this
process.
CHAIRMAN JACKSON: Thank you.
MR. STRONG: Mr. Quillin.
MR. QUILLIN: I would like to review with you some
of the constraints that states currently face in adopting
regulations or implementing regulations. These constraints
particularly come into play when issues of regulatory
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compatibility with NRC regulations are involved.
First, many states, including my own, have all of
their rules and regulations reviewed by their legislature.
In Colorado's law, it is by the Legislative Counsel. If the
Legislative Counsel determines that a regulation is outside
the scope of the enabling statute, the agency that adopted
the regulation has the option of withdrawing the regulation
or appearing before a legislative committee. My experience
is that very few agencies have the legislative committee
agreeing with them and disagreeing with the Legislative
Counsel. In fact, there is a real risk in this encounter of
the committee interpreting issues beyond those initially
under discussion.
While the review normally comes soon after new
regulations are adopted, certain more universal issues
affecting multiple agencies can be addressed at any later
time.
Second, legislatures have the option of sunsetting
regulations after a period of time. In our state, this
involves a statute each year which continues all regulations
with certain identified exceptions. A bill is pending in
our legislature, however, to sunset all future regulations
after three years and all existing regulations on July 1,
1999.
Third, takings are a major issue in the states.
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Takings mean any action of a governmental entity by which
private property is taken or damaged such that a court may
require compensation to the owner. By my count, we have six
bills in our legislature on this issue. They range from
creating a factfinder to help resolve disputes to requiring
removal of any state employee responsible for mandating the
state action or promulgating a regulation which resulted in
a state agency violating a property right.
My division was involved in a takings case which
began in 1987 and ended in 1995. The state won the case in
the Colorado Supreme Court, having lost in all of the lower
courts. The plaintiff appealed for rehearing before the
Colorado Supreme Court and was denied and asked for a
hearing before the U.S. Supreme Court and was denied. While
the state ultimately won this case, it took a long time and
considerable resources to litigate this case.
Fourth, cost-benefit considerations are becoming a
more important consideration in justifying regulations. In
our existing administrative procedures process, we must make
a cost-benefit finding. Legislation is pending to require a
more comprehensive risk-benefit analysis if the cost of
implementation of a regulation is estimated to exceed $1
million. This cost includes the cost to the state, its
citizens and persons affected by the proposed regulation.
No time limit is specified.
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Because of legislation passed last year, our Air
Pollution Control Division has had to hire an environmental
economist to perform specific analyses required in that
area. The State of Washington, in a revision to their
regulatory development process last year, now requires a
small business economic impact statement.
I must challenge the Nuclear Regulatory Commission
to do more thorough and documentable cost-benefit analyses
in their regulatory processes. When we have had to adopt a
regulation due to compatibility requirements, I honestly
have not found the NRC analyses to be that supportable or
transferable.
CHAIRMAN JACKSON: You're saying that this is true
across the board?
MR. QUILLIN: In the ones that we've had to adopt,
yes. We've had very great difficulty in trying to translate
that into the local environment.
CHAIRMAN JACKSON: Now, some of our rules have to
be subjected to a backfit analysis. That does not give you
the kind of cost-benefit information and documentation that
you think you need. Is that what you're telling me?
MR. QUILLIN: One of the weaknesses is that the
basic assumptions, and I'll give you an example on the
current rulemaking on incident reporting, the assumption
there is that we have three choices. We either adopt a rule
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or we put this into regulation or we basically do nothing.
And the decision was to adopt a rule.
The assumption, I think, was that 20 hours would
be used to perform one of these analyses as to whether it's
an incident that needs to be reported or it's not, and the
cost is whatever your hourly cost is -- $117 an hour, or
something like that. So the total cost to a licensee is
$2,000.
Our experience in this is that that underestimates
the time involved and the expense involved in doing that
kind of analysis on a routine basis. That may be just our
experience, but that's basically the experience we've had.
We're involved in a case right now where it's
questionable whether it was or was not intentional and
whether it was or was not regulated material. I spent
probably 10 hours of my own time on that particular case,
trying to figure out and help the licensee through the
process. I know the licensee has spent at least 20 hours on
that case.
I think the cost-benefit analyses have to look at
more options and give a degree of uncertainty that the range
may be as low as such and as high as such and we think the
average is such, so that you have a better feeling for what
the cost is going to be.
Sixth, most, if not all states, have
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Administrative Procedures Acts. Ours requires a public
hearing on proposed regulations. While you attempt to
resolve all issues prior to the public hearing, you never
know who will appear and what they may say. If the comments
received at the hearing appear reasonable, the hearing panel
may require that you start all over in the process, with
consequent delays. I can assure you that panels do not like
to have major controversies presented to them in a public
hearing and that compromise is the order of the day.
I skipped fifth, which is our goal is to achieve
compliance with our regulations. Our priority is to use
compliance assistance to achieve this, not enforcement. I
recognize that enforcement must be used in certain cases,
but in the long run, compliance assistance is more effective
and more acceptable to our customers.
Our goal is the win-win situation. We have one
licensee that we have been at swords points for years. We
both recognized that this was not a productive use of their
or our resources. Using a TQM process, we have now resolved
a number of major issues and developed a positive working
relationship. Win-win results are achievable.
Seventh, there are frequently jurisdictional
overlaps in the states. A prime example are licensing
boards. Some of these boards may guard their turf
jealously. When the NRC issues a regulation which requires
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certain qualifications of an already state licensed
individual, there is always the potential for conflict in an
Agreement State.
There may also be jurisdictional overlaps with
agencies that regulate activities such as hospitals or
health care organizations or other non-health care
organizations and companies. These overlaps must be taken
into consideration as an Agreement State adopts regulations
and appropriate compromises are subsequently made.
Eighth and last, Colorado may be unique but we
have a self-audit statute which provides confidentiality for
audits done by regulated entities. This confidentiality
does not apply to records or surveys which are required
specifically by statute or by regulations. NRC's
regulations and our regulations require many such surveys
and records. However, we are limited to these and cannot
use any other materials a licensee develops itself.
This is a particular problem in the EPA programs,
where there is less specificity in surveys and records
requirements. Obviously any additional records which we
might want to require in the future would have to meet the
cost-benefit considerations.
In summary, the Agreement States face challenges
in the adoption of regulations and in the implementation of
regulations which go beyond those faces by the Nuclear
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Regulatory Commission. As the NRC sets compatibility levels
for its regulations, it needs to consider the challenges
that the Agreement States face in adopting identical or
similar regulations.
CHAIRMAN JACKSON: Are you done?
MR. QUILLIN: I'm done.
CHAIRMAN JACKSON: Mr. Hill.
MR. HILL: Thank you. My comments parallel
somewhat those that Terry started the briefing with.
The Agreement States relationship with NRC for
years has been one of reactivity, and there's no pun
intended with that. The Agreement States have reacted to
actions initiated by NRC. We are and have been comfortable
in that role. I believe NRC is also comfortable with the
Agreement States being in that role.
It's much easier for NRC to respond to the states
when we are reactive. After all, NRC has initiated rules,
licensees have reacted to that, NRC has responded to that,
and that seems to become the relationship the NRC and the
Agreement States have had and probably is the basis for the
Agreement States' long-standing complaint of being felt
treated as licensees.
When the Agreement States endeavor to shift from
reactive to being pro-active, it moves us out of our comfort
zones, and I believe it moves NRC out of its comfort zone,
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also. As evidence, I put forth the Adequacy and
Compatibility Resolution by the Agreement States in 1989 and
the Agreement States' desire for early and substantive input
into rulemaking.
Looking back a little bit, on October 30, 1995 at
the NRC Agreement States meeting, Wayne Kerr gave what he
referred to as a progress report card on the issue of
adequacy and compatibility. I'm not going into that further
here, as that's available in the transcript of the meeting.
At that meeting we saw and heard about the
progress being made in early and substantive input in
rulemaking and other initiatives affecting the Agreement
States. Examples included states' involvement in IMPEP
reviews, in the NRC working groups, in state input at the
draft rulemaking plan stage.
Progress has been made and I trust will continue
to be made as we work to become accustomed to changing
roles.
There is another area that I believe we need to
work closely with NRC, rather than reacting to NRC, and
that's the area of strategic planning.
Since I first drafted these thoughts, two items
come to my attention that I think illustrate the difficulty
with accepting changing roles. On the 31st of January 1996,
a Federal Register notice was published announcing a
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proposed addition to Part 20. This has been mentioned here
already today, Section 20.2205, entitled "Reports of
Unauthorized Use of Licensed Radioactive Material." The
states did not have an opportunity for early input into the
proposed rule.
The second item has to do with states' input into
rulemaking. The current bulletin board process provides for
Agreement State input into a draft rulemaking plan. This is
an effective process. Through interactions with NRC staff
in recent weeks I've become generally aware that the
Commission is possibly considering revisions to the
rulemaking plan process. The Organization of Agreement
States would not welcome any revision that would reduce the
opportunity for Agreement States to provide early and
substantive input into the rulemaking planning process.
NRC's proposed rules affecting materials licensees
generally require that the Agreement States adopt an
equivalent rule to maintain a compatible program. When the
Agreement States have the opportunity, based on their
experiences, for early and substantive input into the
rulemaking plan, as well as the proposed rule, they're more
likely to support the final rule.
Since the final rule has been defined at the
planning stage, comments at later stages in the rulemaking
process by the Agreement States have resulted in few
. 28
modifications to NRC's positions.
Current challenges that are facing the states, as
well as NRC, include budget cuts, shifting regulatory
emphasis from prescriptive to performance-based rules, a
reduced materials workload for NRC as more states sign
agreements, NRC's rebaselining initiative, and the report by
the Institute of Medicine of the National Academy of
Sciences.
Budget cuts. We have been hearing about and are
aware of budget cuts at the federal level. We at the states
are also experiencing budget cuts. In Georgia, the budget-
cutting effort is referred to as redirection -- a
redirection of resources from lower priority areas to higher
priority areas within the state.
Also coupled with the redirection is the
privatization of certain state activities. Governor Miller
has mandated a 5 percent redirection or budget cut for each
of the next three fiscal years. The total will be greater
than 15 percent, since inflation cannot be considered after
each year.
Performance-based rules. We're also aware of the
desire of the regulated communities for a shift away from
prescriptive rules to performance-based rules. NRC's been
working in this area with rulemaking for some time, and the
trend towards performance-based rules appears to be gaining
. 29
momentum. I had a gentleman in my office just last week
talking about performance-based rules and the industry's
desire for those.
NRC is either currently regulating as many
materials licensees as some of the larger Agreement States,
or will be in the not too distant future. Massachusetts is
to become an Agreement State in 1996 and Ohio, Oklahoma and
possibly Pennsylvania may become Agreement States a few
years later.
To touch on the rebaselining issue, NRC is
undertaking a rebaselining initiative, as described by Hugh
Thompson at the October 1995 NRC Agreement States meeting.
A 13-member committee is charged with reviewing NRC
activities to ensure that these activities are in line with
NRC's mission.
We understand that the initiative is to be
completed by the fall of 1996 and consists of four phases:
reviews and assessment of some 4 to 5,000 on-going NRC
activities; strategic planning, resulting in a new set of
goals and strategies; organization of NRC; and human
resource assessment. My interpretation of human resource
assessment is doing more with less staff. Or it could
possibly mean having staff do different things.
Will the rebaselining effort of NRC, by default,
redefine, via compatibility and adequacy, the way Agreement
. 30
States regulate?
The National Academy of Sciences report. Since
the NRC Agreement States meeting last October, the Institute
of Medicine, National Academy of Sciences, released their
report entitled "Radiation in Medicine, a Need for
Regulatory Reform." The implementation of the
recommendations in the report can greatly impact the way the
NRC and Agreement States regulate the use of radioactive
material in medicine.
Those are all activities that are currently facing
NRC, in a very abbreviated form, and the Agreement States.
I think they kind of speak to a challenge that we have, and
I enumerated those to ask this question: What will the
regulatory playing field look like in, say, two, three, or
even five years from now?
I believe that NRC's rebaselining effort will
result in shaping of the regulatory playing field.
Impacting the shape of that field are the budget cuts,
performance-based rules, NRC's reduced materials regulatory
workload, and how we, the NRC and Agreement States, regulate
the medical use of radioactive material.
The challenge, as I see it, is for NRC and the
Agreement States to pool our resources, work cooperatively
to create on paper, by the fall of 1996, the future
regulatory playing field. We must then continue to pool our
. 31
resources and work cooperatively to create that future in
reality.
Otherwise, the Agreement States and the NRC will
be in the old, comfortable position of the Agreement States
reacting to NRC initiatives and the full benefit of the
resources of the NRC and Agreement States working together
will not be realized. NRC and the Agreement States must be
willing to work outside our comfort zones.
How, then, can we work together to create our
future? I suggest another working group or similar approach
that will look to the needs of NRC in view of NRC's
baselining activities and the needs of the Agreement States
who regulate, among others, machine-produced radiation and
naturally occurring accelerator-produced radionuclides.
Objectives of this group would be to ensure that the
regulatory playing field of the future is fair to the
Agreement States and to the NRC and that it will not
adversely impact the varied needs of the states.
Thank you.
CHAIRMAN JACKSON: Thank you very much, Mr. Hill.
Let me make a couple of comments and let me ask a
few questions, and then I'll allow my fellow commissioners
to do so, also.
If I listen carefully to much of what each of the
four of you have said, one would get the impression that the
. 32
Agreement States are feeling like second class citizens and
that you would not like to continue to be treated as such.
And so it strikes me that the overarching question
is how to bring your state expertise and needs to bear in a
consistent and comprehensive way in our regulatory
processes; in particular, those parts of it that affect you
the most.
And it also strikes me that you've also spoken or
interwoven through much of what you've said are the ways out
of it, of what you might feel to be this second class
citizenship. And so I guess I'd like to kind of walk
through some things that struck me and get your reactions to
those. Then I will speak to a couple of the points that
different ones of you, but particularly Mr. Hill, raised.
I think interaction and communication is what I
heard. Now, my understanding is that, and particularly up-
front interaction in the areas that are of greatest concern
and impact to the Agreement States, and I know that there
are various working groups and, in particular, with respect
to the on-going implementation of a new adequacy and
compatibility policy statement. And I guess I'd like to get
some assessment from you of how well that is working, since
you, in fact, spoke to difficulties that some of the
compatibility requirements pose for you. So I'd like to
understand that a little bit better.
. 33
MR. STRONG: Let me just start, but nobody's shy.
CHAIRMAN JACKSON: That's clear.
MR. STRONG: You have an institution that, within
certain limits, goes on. Staff does not change, the same
people that we would deal with over a period of years. It
doesn't change very much. Every year, there's a new guy
that sits at this table to give this briefing to you.
And I suppose, within certain limits, our
organization doesn't change an awful lot, but I think that
it's more difficult for us to relate back to you
consistently, and we don't relate to you very often -- once
a year. Maybe we can get you to come to a meeting and speak
to us or something like that.
CHAIRMAN JACKSON: All you have to do is invite
me.
MR. STRONG: And we have and we will and you'll
not be off the hook for that.
The consistency -- I think we feel like we're at a
disadvantage, in order to deal with you consistently,
because our group changes, and I'm not sure what to do about
that. Tom's idea of a new working group -- I don't know if
we need another committee. I'm not sure we know what else
to propose, but another committee on top of what we are
doing now?
Something that brings permanence, something that
. 34
is really effective so that we're sure that you hear us and
what we're concerned about is -- maybe we can explore that,
that we can figure something out right here, and I don't
know where Bob and Richard might want to go with that.
MR. RATLIFF: I feel that your basic question is
are the working groups actually being successful, and I
think the answer is yes. I know the IMPEP group has really
worked well. It's bringing the state counterpart in with
the NRC. It helps the state members because they'll know
what to expect when they're reviewed. I think overall,
that's going to be a real successful effort.
Having the states have four representatives on the
management review board is going to really help because
that'll, I think, give the state who's in the hot seat -- at
least know that one of their compatriots is out there, and I
think we'll hold them to an equally or higher standard than
you will, which is good, and I think overall that'll help.
The adequacy and compatibility -- when I asked for
volunteers it surprised me that I got people. That's going
to be the hardest one, going through all of the NRC rules
and determining what division of compatibility has got to be
the most onerous job that anybody's taking on, and those
three people I think will do well.
So I think we've really improved relations. It's
just certain areas that we get into I think where we feel
. 35
uncomfortable and certain things where, like you said, all
of a sudden we feel that we're going along as regulatory
partners and all of a sudden we're not invited to the dance;
we're left at home. I think that's where I see us coming
from.
CHAIRMAN JACKSON: Another area that it strikes me
is ripe for helping to address some of your concerns is in
what I would call specificity of assessment. You talked
about industrial radiography and you gave a good assessment
of the historical problems, where you are now, et cetera.
I think that from my perspective, what's helpful
in being able to address where there may be difficulties is
to try to pin down, as much as possible, where they are,
where the difficulties are, and what could address them.
So I would just encourage you along the line of what I'll
call specificity in assessment.
A third area which all of you have alluded to is
the one of resource commitment. I think it's important when
the Organization of Agreement States is assessing its needs
or, conversely, if one is looking at what our program
requires of you and what you thereby need, to understand
from a resource commitment point of view what is really
needed, but that includes what will things really cost, and
then to have discussions about what is actually available.
Now, I know about the issue having to do with the
. 36
training and travel funding for states, and I'm not going to
speak to that specifically today because that is under
active consideration and will be under active consideration
with discussions with your organization. But one has a
federal agency, which is a federal agency, but that is
funded through licensee fees, and one has an Agreement
States program where, by definition, those who are regulated
in those states are not licensees of the NRC.
And so the question becomes what are the real
needs and how and who is going to pay for them, or how is
that going to be partnered, particularly when in our
appropriations legislation certain areas, including the
Agreement States program, gets singled out for criticism.
So that is why the Commission is considering this
as part of the overall strategic assessment, because it has
to be considered within the broader context. It's not a
simple matter of continuing or not continuing, but the issue
becomes how does it work within the broader context?
You mentioned cost-benefit, and you criticized how
the NRC does it. I think it would be very helpful, from an
Agreement States perspective, that you help to do some of
that calculation.
Now, the difficulty is going to be the variability
from state to state. But again, because you are the
Agreement States organization, there may be a way that you
. 37
could contribute in terms of laying out options or bounds in
that process.
And then let me just march down the list that Mr.
Hill talked about. The budget cuts -- we are facing budget
cuts, and that's not likely to go away, but that is also why
my earlier comments about what things cost versus what makes
sense to do and who's going to pay or how is it partnered is
part of a larger discussion.
You mentioned performance-based rules and again, I
think that is one that's ripe for continued discussion and
intense interaction.
You mentioned rebaselining and human resource
assessment and you made what I might consider to be some
pejorative comments, but I didn't take them as such because
I don't think that it's a question of necessarily leaning
one way or the other. It's a question of looking at where
our overall programs are going and what is on our plate,
what looks like it's coming onto our plate, and deciding
then how do we address that, what our human resource needs
are. And it's not something that's meant to cut any given
player out of the game because the NRC has many stakeholders
in the process, and there are many who are concerned about
the regulatory playing field, as it were.
The National Academy of Sciences report and how
we're going to interact and decide how to react to that
. 38
report is not something that's going to be done in a
precipitous manner, and it obviously is something that
requires intense interaction with the states. That would be
all the states, because they would be affected.
So all I ask you to do is not to prejudge what you
think the outcome is going to be, because I haven't
prejudged it and I don't think obviously my fellow
commissioners have prejudged that.
And so again I go back to saying I think we all
have to operate in good faith, but the greater the degree of
specificity in assessment and recommendation and process you
can bring to us, the greater the possibility of making
progress on the issues that are of concern to you.
I'll make some other comments later but I'd like
to give Commsisioner Rogers and then Commsisioner Dicus a
chance to pose any questions or comments they'd like.
COMMISSIONER ROGERS: Well, I think your comments
have been very interesting. They are not entirely new, of
course. Some of these are issues that have been around for
a long time and we've been working on but they are very
difficult ones sometimes.
I'd just pick up on what the Chairman has said
with respect to the specificity. I think that in trying to
find ways to alleviate some of the shortcomings of our
interactions that we really do need help on this in how to
. 39
do it because I think that we can sit here and think of
things in generalities but it is really a specific fix of
some sort that ultimately has to come about. And I think
your contributions to us in that regard could be very, very
helpful.
I think this is not an area where one wants to be
singlemindedly too creative. I think it has to be a joint
kind of activity, that we have to find something that meets
your needs and our needs at the same time.
And that brings me back to the relationship that
we have, which is a very peculiar one in many ways. It is
one in which you are given responsibility for a big piece of
what NRC ordinarily does and yet somehow we are still held
accountable for what you do.
That became very clear to commissioners some years
ago when a congressional committee began to be very unhappy
with the way we dealt with the Agreement States program and
held us very personally accountable for any kind of
shortcomings that they could perceive in what happened in
any of the Agreement States. And it was a very
uncomfortable period for the Commission. We were quite
thoroughly beaten up, I think somewhat unjustly but not
entirely so.
And it illustrated the very complicated
relationship that we have, where we, in fact, hand over,
. 40
through the Agreement States program, responsibility to you
and yet whatever happens in the Agreement States that
involves radioactive areas that have a health consequence,
we will be held accountable for them, and personally
accountable for them. It's something that you have it but
we haven't given up our responsibility.
And it's a relationship that can only work, I
think, through very close interaction and very close
communication because I think otherwise, we're bound to see
the same kind of problems arise time and time again in the
future, where something happens in an Agreement State and
NRC is held accountable for it and NRC says, "But we really
aren't directly involved there," and that doesn't satisfy
anybody when we have to say that in a congressional hearing.
And so that means that very strong communication is quite
important.
And what I hear is the pain of this relationship,
in a certain sense, that it is a peculiar one. I don't
think -- I would characterize your perception a little bit
differently from the Chairman's. I don't think you see
yourselves so much second class citizens --
CHAIRMAN JACKSON: No, being treated that way, not
that they are.
COMMISSIONER ROGERS: Well, or being treated that
way, but being treated in a way that everybody else is being
. 41
treated, whereas, in fact, you have a considerable
additional responsibility.
And so what you're asking for is a recognition of
that special status that you have that is different from
non-Agreement States. And it seems to me that that's where
part of the problem arises, in how to do that.
I think that we can be much more communicative
with you than we have been, but I know that from time to
time there have been legal issues raised with respect to how
communicative we could be with you on, for instance,
rulemaking.
And I don't know. I don't want to put Mr. Malsch
on the spot but Mr. Malsch, I wonder if you could comment in
any way easily on where the limitations might arise with
respect to the Commission recognizing input from the
Agreement States very early on in a rulemaking, where we
haven't had a chance to go public with it to everybody.
MR. MALSCH: I think at an early stage there
really are very few limitations. Offhand, I can think of
none. I mean, the analogy to rulemaking is legislation,
which is pretty much an open process. For informal
rulemaking, it is an open process. It's not a very
structured process. There's no prohibitions on ex parte
communications or separation of functions.
So especially early on, I think there are very few
. 42
legal limitations.
COMMISSIONER ROGERS: Do you think that we've been
too cautious in eliciting responses from the Agreement
States in rulemaking?
MR. MALSCH: Well, if we have been reluctant
because of legal considerations, I think we may have been
too cautious, but I think maybe other considerations may
have been driving it, also. But from a legal standpoint,
there are very few legal limitations associated with early
interaction in rulemaking.
COMMISSIONER ROGERS: Well, I think that we have
to keep that very much in mind.
I wonder -- there are some specific questions.
One is, Mr. Quillin, you talked about this problem and the
Chairman touched on it, as well, of more realistic
assessment of how much time it takes to do an analysis or to
comply with an NRC regulation.
Do you have any thoughts on how we can get better
data in this area? It seems to be a recurring problem all
the time, that we're accused of underestimating the costs of
some kind of new regulation. And yet I'm sure our folks try
to do the best they can.
I wonder if there's any way that you could be
specifically helpful to us in creating a database that's
more valid.
. 43
MR. QUILLIN: I don't think it's necessarily
creating a database so much as it's creating a process where
you can gather the information for the database.
I think one of the problems is that once you have
a rulemaking in progress, you get in a time frame and you
don't have much time to operate in to gather that
information. So I think estimates are made which may or may
not be valid.
I think there needs to be a way that you can go
outside the system you have now to gather that information
and to try to analyze it and present it in a more thorough
basis.
So I think it's the system and the process that
needs to be looked at.
COMMISSIONER ROGERS: Well, maybe we can't come to
something right here at the table but I do think this is
something that we ought to attack and see if can't find a
way, some new mechanisms that produce more satisfactory
results.
I think perhaps we've been using the same computer
program that the IRS uses to calculate how long it takes to
make your income tax, and that doesn't seem to work very
well.
I think I'll pass.
CHAIRMAN JACKSON: Thank you. Commissioner Dicus?
. 44
COMMISSIONER DICUS: Thank you, Chairman Jackson.
I find myself in this remarkably unique position,
having sat on both sides of this table in these kinds of
discussions. And I have a proximity, a close proximity,
both in time as well as knowledge to the issues that are
being discussed.
And for that reason, I really don't have any
comments and I'd have to say at this point in time, at least
not yet, any questions.
CHAIRMAN JACKSON: Okay.
Let me ask you two specific questions and then, if
we're done, I have some closing remarks.
As you know, the Commission continues to evaluate
the extent to which our low level waste regulatory program
should be reduced, if at all. Do the Agreement States have
any belief that we should cut the program, or have you
thought about that? And if so, which activities would be
candidates for reduction?
MR. STRONG: If you look at how many sites you
license, then it would seem to me that you could reduce the
amount of effort, the number of FTEs that you have. And
from the looks of the national picture, there are going to
be very few new licensed low level waste disposal sites, it
would seem.
But at some level, it does to me, to the State of
. 45
Washington, to the Northwest Compact -- I wear two hats; I'm
the chair of the Northwest Compact -- that there ought to be
somebody with the resources, with the capability to continue
to look at this process from a technical basis, from a
research basis, which the states or the compacts really are
not prepared to do.
I don't know where to draw that line. I can't be
more specific than that, but I'm willing to sit down and
let's take a look at exactly the process that we would have
to enter into. But for the NRC to keep a staff in
anticipation of licensing the next low level radioactive
waste disposal site that comes on line, that's really not --
you don't need to spend your FTEs in that area.
MR. RATLIFF: I think it parallels one of the
other areas you touched on -- the fees and who pays for it.
It's an area that could help NRC if you have an application
for a waste site. It obviously helps the NRC reactor
licensees who have to get rid of their low level waste, and
yet it may be that you have no direct licensee to charge
these costs to.
I think it's one of those areas that I think it's
been beneficial because going through this process, you're
able to provide some assistance to the states, who are on
the forefront, having to go through and combat the multiple
groups who have an agenda that's not based on safety but is
. 46
based on we don't want reactors, we don't want waste.
So we run into real problems there. And I think
your data, working with the data that we develop on a site-
specific basis, is beneficial.
CHAIRMAN JACKSON: Any other comments?
MR. QUILLIN: Yes. I have the benefit of having
served on two different compacts -- the Midwest Compact and
now the Rocky Mountain Compact. And in neither of those
terms, so to speak, did I really see any benefit that the
Nuclear Regulatory Commission provided to the compact
itself. There was some benefit that was provided through
the Department of Energy activities but not through the NRC
activities.
So one of the problems, I would say, is you need
to look at the customers you have for this program and
whether you're providing service to these different types of
customers, whether it be a compact, whether it be a state
that's developing a site and trying to establish criteria
for siting. Whatever it is, but you need to look at your
customers and see are your services focussed towards your
customers?
CHAIRMAN JACKSON: Okay. Mr. Hill?
MR. HILL: No comments.
CHAIRMAN JACKSON: Let me ask you another
question. Now, this, as I mentioned earlier, will be part
. 47
of a longer and on-going assessment, but I do invite any
views or comments you might have on the report of the
Institute of Medicine on the NRC's regulation of the use of
radioactive material in medicine.
Do you have any overarching comments you'd like to
make at this time?
MR. QUILLIN: I can say that I serve on the ACMUI,
so we've already made our comments.
MR. STRONG: Let me go, Richard. Then you can
deal with the specifics.
I think some interpretation of the report would
say that some physicians want NRC out of the business
altogether of regulating the radioactive materials that are
used in nuclear medicine. And I think that that probably
goes too far. I don't think that we would look at it that
way.
And so maybe the Nuclear Regulatory Commission
should not be practicing medicine, but they should not be
out of the business of regulating the materials that are
there. In Agreement States we are not going to stop doing
that. In non-Agreement States, I wouldn't think that you
should bail out altogether.
I don't know if that's the kind of dichotomy
you're looking at, but it's still radioactive materials.
It's still out there. There's still a public health and
. 48
safety issue that is there with regard to the use, not in
the practice of medicine but in the protection of the public
health from the radioactive materials, from exposure.
MR. RATLIFF: I feel this is one of the areas
where it was more politically driven as the NRC medical
rules developed and the Congressman Synar hearings, where
they were looking at past instances and really a relatively
small percentage of misadministrations occurring, and yet
bringing that to the forefront. And I understand in each of
our states we're before legislative committees where they're
just as hot, just as intense.
But I think one of the problems is that the rules
went too far. I know when I sat here last year and the year
before as president-elect, we recommended that the QM rule
was too strict. The regulation of nuclear medicine really
had to look at a balance.
We knew the states did not have resources to
review large quality management plans. We felt that that
was a waste. We knew NRC had to go out on contract, and
even the contractors, after they reviewed them, found most
of them were inadequate. So there was something wrong with
the system.
And my suggestion then was that we really look at
concentrating on health and safety. What rule would be more
effective in eliminating misadministrations, making sure
. 49
they're reported but not be so burdensome on the licensees
and the states? I think that's where we're going to have to
go.
CHAIRMAN JACKSON: Okay.
MR. HILL: You asked for overarching ideas and I
don't think I can add anything to what Terry and Richard
just said. It seems like that summarized it pretty well
from the Agreement States perspective.
CHAIRMAN JACKSON: Mr. Ratliff, you mentioned
medical administrations. In looking at it, it appears that
the number of events reported by Agreement States appears to
be significantly fewer than that reported by the NRC. Do
you have any thoughts as to the source of that difference?
MR. RATLIFF: I think part of it is randomness
because we'll have certain incidents that, regardless of how
well we've regulated a particular licensee, they'll have an
individual who makes a major mistake. But I think partially
the states, through the medical boards -- we regulate the
medical community; we do x-ray inspections; we inspect NORM.
We have much closer connections with the medical facilities,
and I think that's beneficial in the long run.
CHAIRMAN JACKSON: Okay.
Commissioner Rogers?
COMMISSIONER ROGERS: No, I don't have anything.
CHAIRMAN JACKSON: Commissioner Dicus?
. 50
COMMISSIONER DICUS: (Shakes head.)
CHAIRMAN JACKSON: Well, Mr. Strong, the
Commission would like to thank you and your colleagues for
an excellent summary of your views of the Agreement State
program. The Commission is particularly pleased to hear
that you intend to conduct your future annual meetings at
NRC headquarters each fall in order to facilitate the kind
of interaction and communication we've been talking about
with the NRC staff, as well as with the members of the
Commission.
And the Commission encourages you and the NRC
staff to continue to work together in order to successfully
carry out this very important program.
And I would just, in closing, like to bring your
attention back to four points that seem to have come out
today. They are, first, as both Commissioner Rogers and I
have spoken of, a mechanism for interaction generally,
whether there are improved mechanisms that might exist, as
well as mechanisms for earlier input to regulation and
rulemaking.
Secondly, it is very important that there be
specificity in assessment and recommendations coming out of
any assessments that are made, that are as specific as
possible.
Third, that you work and help us to work to
. 51
understand better resource commitments that would be
involved with what your needs are but also what you think
resource commitments or costs would be relative to any
regulations we might be promulgating.
And related to that, then, is the fourth, which is
I think you have a role to play in developing cost-benefits
options and bounding, given the variability of the various
state programs.
So again I thank you very much for a thorough
briefing, and if there are no other comments, we're
adjourned.
[Whereupon, at 11:17 a.m., the briefing was
adjourned.]
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