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UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
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BRIEFING BY NATIONAL ACADEMY OF SCIENCES
ON REVIEW OF MEDICAL USE PROGRAM
- - -
PUBLIC MEETING
Nuclear Regulatory Commission
One White Flint North
Rockville, Maryland
Tuesday, February 27, 1996
The Commission met in open session, pursuant to
notice, at 2:00 p.m., Shirley A. Jackson, Chairman,
presiding.
COMMISSIONERS PRESENT:
SHIRLEY A. JACKSON, Chairman of the Commission
KENNETH C. ROGERS, Commissioner
GRETA J. DICUS, Commissioner
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STAFF SEATED AT THE COMMISSION TABLE:
JOHN C. HOYLE, Secretary of the Commission
MARTIN MALSCH, Deputy General Counsel
COMMITTEE MEMBERS PRESENT:
CHARLES E. PUTMAN, Chairman
KATE-LOUISE GOTTFRIED, Study Director
WILLIAM HENDEE
JOHN VILLFORTH
DAVID GOODEN
THEODORE PHILLIPS
GARY PENN
CARL PAPERIELLO, Director, NMSS
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P R O C E E D I N G S
[2:00 p.m.]
CHAIRMAN JACKSON: Good afternoon, ladies and
gentlemen. The Commission would like to welcome members of
the National Academy of Sciences Committee for Review and
Evaluation of the Medical Use Program of the Nuclear
Regulatory Commission.
As you know, in July of 1993, the NRC requested
that the National Academy of Sciences conduct a review and
evaluation of the NRC's regulatory program for the medical
use of byproduct material. At that time, the NRC requested
that the National Academy of Sciences examine the broad
policy issues which underlie the regulation of the medical
uses of radioisotopes. The Commission was also interested
in an examination of the overall risk associated with the
use of ionizing radiation in medicine.
Finally, the Commission was interested in having
the National Academy perform a critical assessment of the
current framework for the regulation of the medical uses of
byproduct materials.
Based on the assessments that I just mentioned,
the Commission requested that the National Academy make
recommendations for an overall uniform national approach to
the regulation of ionizing radiation in medical applications
as well as for appropriate criteria for measuring the
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effectiveness of the regulatory program.
In December of last year, the Academy issued its
report. Today the Commission will be briefed by the members
of the Committee who prepared the report.
On behalf of all of the commissioners, I would
like to thank each of you for taking the time to come and be
with us today.
Before we begin, Commissioner Rogers or
Commissioner Dicus, do you have any opening comments you
would like to make?
COMMISSIONER ROGERS: Not at this time.
COMMISSIONER DICUS: No.
CHAIRMAN JACKSON: If not, you may proceed.
DR. PUTMAN: Thank you, Chairman Jackson. It is a
pleasure for all of us to be here. And let me briefly
introduce my colleagues.
On my far right, David Gooden, professor of health
physics from Oklahoma.
John Villforth. Professor Villforth probably
needs no introduction to this group, been very active in
Washington for many years and serving in a variety of
capacities.
On my immediate right is Dr. Bill Hendee, a
physicist in research from Wisconsin.
On my far left is Gary Penn, staffmember at the
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Institute of Medicine.
Then we have Kate Gottfried here on my left who is
the executive director of the IOM study.
And, with that -- I'm sorry Ted.
Ted Phillips, University of California in San
Francisco, radiation therapist.
What we have planned to do is for Kate Gottfried
to introduce the topic with a few overheads.
Are we ready to do that, Kate, do you think? We
had some trouble with the projector.
CHAIRMAN JACKSON: Just ask for what you want. It
will appear if it is here.
MS. GOTTFRIED: Printouts of the slides were
available when you entered the room so those -- all those
slides will not be run through this afternoon in the
interest of time to really get to the heart of the topic
which is the discussion of the substantive issues contained
in the report.
I want to thank you first for the opportunity to
speak with you today and present on behalf of the Committee
and we are very pleased to be here to enter into a dialogue
with respect to the issues contained in our study.
The first slide, please.
[Slide.]
MS. GOTTFRIED: This is just a review, briefly, of
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the statement of task, the three major goals that were set
forward: To examine the broad policy issues that underlie
regulation of the medical uses of radioisotopes; study the
overall risks associated with the use of ionizing radiation
in medicine, comparing the errors and consequences of the
use of byproduct materials to other medical interventions
and the use of byproduct misadministrations to properly
conducted administrations; and, finally, an assessment of
the current statutory or regulatory framework for regulation
of medical uses of byproduct materials.
Next slide, please.
[Slide.]
MS. GOTTFRIED: I am sure we are all very familiar
with the medical policy statement. That is just provided as
it was a guideline to the Committee members during our
deliberations throughout from day one, really, through the
end of this study, keeping in mind what the NRC's policy
statement reflected.
The next slide, please.
[Slide.]
MS. GOTTFRIED: The Committee's goals were to
promote greater uniformity of regulation of all ionizing
radiation in medicine, specifically the regulation of
byproduct and nonbyproduct material. To shift the federal
oversight to an agency experienced in matters of public
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health and to further ensure adequate protection of the
public's health and safety and to consolidate the regulation
of all ionizing radiation in medicine by delegating
regulatory authority for reactor-generated byproduct
materials to the states, which presently regulate NARM or
approximately 90 percent of radiation medicine.
The next slide, please.
[Slide.]
MS. GOTTFRIED: The Committee underwent a long and
deliberative process with respect to developing a spectrum
of alternatives that could be considered and then finally a
focus on a particular alternative that would form the basis
for the recommendations put forth in our report.
Before I discuss the particular alternative, I
want to just touch briefly on the spectrum of alternatives
to say that the Committee really wanted to look at as many
options as possible before determining where the emphasis
should be and, in fact, if you look in the report, there is
alternative A through G.
The focus of the Committee, though, really
centered on alternative C through F. And C, D, E and F
really comprised the heart of the discussion and the
deliberations of the Committee throughout the period that we
undertook the study.
Alternative C really emphasizes state control.
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Alternative D emphasizes -- and I will elaborate further on
Alternative D -- but emphasizes authority delegated to the
states with some federal oversight and guidance.
Alternative E reserves residual authority so in the instance
where the states would have an opportunity to regulate, if
in fact the state didn't regulate, the feds would have the
opportunity to assume control over a particular state
program. Alternative F really emphasizes central regulation
of all ionizing radiation in medicine. Alternative G was
really quite comprehensive and tied reimbursement and
regulation issues all together under one central agency for
all of medicine.
CHAIRMAN JACKSON: Could you comment briefly,
though, on Alternatives A and B?
MS. GOTTFRIED: Certainly.
Alternative A, actually A-1 and A-2, A was the
status quo with absolutely no change in the existing program
as it is today, the medical use program of the Nuclear
Regulatory Commission. A-2 was the status quo with a slight
modification, which would be the elimination of 35.32 and
.33.
And alternative B was what we entitled the liaise
faire approach which was really no regulation to speak of
and an open market to allow free enterprise to really take
hold.
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CHAIRMAN JACKSON: So you started from the premise
that Alternative A, either in A-1 or A-2, was not really a
viable alternative and therefore not to be considered?
MS. GOTTFRIED: Well, it was entertained as an
option but it was the -- the pros to Alternative A were
considered and the cons were considered and I believe the
Committee felt that Alternative A did not really address the
issue of uniformity with respect to byproduct and
nonbyproduct material.
COMMISSIONER ROGERS: I guess, could you just give
me a little better feeling about where the status of the
Committee's goals -- what that was? I mean, when did the
goals emerge and normally you start out with something as
goals at the very beginning. On the other hand, these goals
read a little bit like your final conclusions. So when did
they emerge in the process as goals?
MS. GOTTFRIED: The goals emerged during the
process, I would say about mid way through the -- by the
third or fourth meeting. They were clarified, I should say,
or crystallized. They were listed -- the sense that there
was a disconnect between byproduct material and nonbyproduct
material was apparent from the inception of the committee
process.
COMMISSIONER ROGERS: It is just that if I look at
two of the three goals, they seem to be very much like your
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final conclusions rather than goals which you set in some
way at the very beginning of the study with the expectation
that something will emerge later on that will -- that will
lead you to those goals.
These look as some rather firm conclusions as to
where you are going to wind up.
MS. GOTTFRIED: Perhaps I should clarify when I
say -- and "goals" may not be the best characterization.
Committee goals, once the spectrum of alternatives had been
considered, so there were goals that were derived after or
during the discussion of the alternatives, not from the
beginning of the Committee. As I said, they didn't really
emerge until the third or fourth meeting. And so they may
be better characterized as, I don't know, the Committee's
outcome from the deliberative process with respect to the
alternatives.
And, certainly, I mean, if we were going to go
back to goals, per se, the initial goal, the overarching
goal, was to ensure adequate protection of the public health
and safety in conjunction with an efficient regulatory
program.
The Committee really wanted to emphasize once, in
fact -- well, regardless of what option we were going to go
with, that federal regulation would be maintained in many
respects. And so, if we could have the slide, please, the
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prior slide --
[Slide.]
MS. GOTTFRIED: That elimination of the NRC's
medical use program would not alter the basic structure of
federal regulation and that the federal government would, in
fact, retain responsibility for the generation, the
transport, the nonmedical use, disposal of radionuclides and
for the approval of radiopharmaceuticals and certification
or approval of equipment that generates ionizing radiation.
The federal authority also would be maintained
with respect to, and this is, again, from the report,
once -- oh, sorry, the next slide, please.
[Slide.]
MS. GOTTFRIED: The NRC and its agreement states
would continue to license the production of byproduct
material for radiation-producing devices and
radiopharmaceuticals within the medical context. The NRC
and its agreement states would, as relate to the nonmedical
use of byproduct material, that being the industrial,
educational and nonmedical research areas, continue to
license the production and use of byproduct material, that
the DOT would continue to regulate the transported regulated
materials and the EPA, of course, would continue to develop
guidelines that set occupational and public exposure limits
to be implemented by the respective federal agencies.
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The FDA would continue to regulate the manufacture
and labeling of radiopharmaceuticals and medical devices and
would regulate the mammography program under the Mammography
Quality Standards Act.
And, finally, slide, please.
[Slide.]
MS. GOTTFRIED: The last two areas where the DOD,
the VA and the PHS would continue to be responsible under
the regulations of the appropriate agencies for the safe use
of radioactive materials and radiation producing machines
within hospitals, their hospitals and laboratories.
And, finally, next slide, please.
[Slide.]
MS. GOTTFRIED: The Health Care Financing -- the
next slide, please. Maybe I am reading faster than --
[Slide.]
MS. GOTTFRIED: The Health Care Financing
Administration for Medicare and Medicaid and other federal
agencies for other health care purchased from the private
sector would continue to develop its reimbursement
guidelines.
The Committee spent an extensive amount of time
deliberating among particularly the Alternatives C, D, E and
F and derived what we then termed the "preferred
alternative." The preferred alternative, Alternative D --
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next slide, please.
[Slide.]
MS. GOTTFRIED: -- is a regulatory structure that
transfers authority to the states and identifies a federal
agency other than the Nuclear Regulatory Commission to work
in conjunction with the Conference of Radiation Control
Program Directors or the CRCPD and other professional
organizations to develop recommended state laws and
regulations for all ionizing radiation in medicine.
This agency that would assume responsibility for
federal guidance would, in fact, do the following
activities: Assist states in establishing regulatory
programs and train radiation control personnel, it would
address the problematic incidents of national concern, it
would educate the public of the benefits and risks of
radiation medicine, conduct research so the science of
radiation medicine continues to advance, collect risk data
or act as a clearinghouse for that data, monitor the effects
of deregulation.
Based on the preferred alternative, the following
recommendations emerged from the Committee. There were
recommendations made to the Congress, to the Nuclear
Regulatory Commission, and then to the Conference of
Radiation Control Program Directors and the states.
Following slides -- slide, please.
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[Slide.]
MS. GOTTFRIED: The next slides are reportage of
the various recommendations contained in the report and are
provided for the benefit of the people attending the
meeting. I know the commissioners have had an opportunity
to review these.
Recommendations to Congress. The first
recommendation is that Congress eliminate all aspects of the
NRC's medical use program, 10 CFR Part 35 and those
regulatory activities conducted under 10 CFR Part 20 that
are applicable to medical uses.
Next slide, please.
[Slide.]
MS. GOTTFRIED: The second recommendation to
Congress is that the Congress direct the Secretary of Health
and Human Services to support, coordinate and encourage the
following activities involving regulation of all ionizing
radiation in medicine:
Support the operation of the Conference of
Radiation Control Program Directors.
Next slide, please.
[Slide.]
MS. GOTTFRIED: Providing a venue for the review
and evaluation of the suggested state regulations for
control of radiation; assist states in implementation of
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their regulations.
Next slide, please.
[Slide.]
MS. GOTTFRIED: Aiding in assessment of the
effectiveness of state programs through the collection and
analysis of data; helping develop survey methods by which
the rate of adverse events for a wide range of procedures
and devices might be measured.
Next slide, please.
[Slide.]
MS. GOTTFRIED: Monitoring the effects of
deregulation; enhancing training and standards for health
care personnel; and investigating future significant
radiation medicine incidents.
Next slide, please.
[Slide.]
MS. GOTTFRIED: The next group of recommendations
pertain to the Nuclear Regulatory Commission. The first
recommendation is that the NRC immediately relax its
enforcement of 10 CFR 35.32 and 35.33 through its present
mechanisms.
Next slide, please.
[Slide.]
MS. GOTTFRIED: That the NRC initiate -- and this
again is an issue of sequencing -- that the NRC initiate
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formal steps under the Administrative Procedure Act to
revoke Part 35 in its entirety if Congress fails to act
within two years in response to the two recommendations
provided to Congress and that were stated earlier.
Next slide, please.
[Slide.]
MS. GOTTFRIED: That the NRC separate the costs of
formulating regulations from the costs of administering
those regulations.
CHAIRMAN JACKSON: Would you comment a little
further on that one?
MS. GOTTFRIED: That would be in the instance
where the Congress had not acted and if the NRC's existing
program were still in effect.
CHAIRMAN JACKSON: No, no, no, what do you mean by
separating the costs of formulating from the costs of
administering? What is the motivation there? Tell me more
of what you are trying to get at.
MS. GOTTFRIED: Okay, I believe that issue relates
to agreement states versus nonagreement states and the way
in which funds were collected from the states and that all
of the states are responsible for -- share the expense of
formulations of regulations.
DR. PUTMAN: David, do you want to comment on
that?
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DR. GOODEN: I think part of the Committee's
thought process there was that we would like to see the
production of regulations and enforcement of those
regulations separated and there not be fees on the licensees
that gave an incentive to the NRC to do things in one way as
opposed to the way they might do them were those fees not
available.
CHAIRMAN JACKSON: You will have to be a little
more lucid with me.
[Laughter.]
DR. PHILLIPS: I'm sorry.
The concern is that as more and more states become
agreement states, the few states that are left are bearing
the burden of writing the guidelines and regulations.
Whereas, those guidelines and regulations really apply to
all of the states and to be fair you should spread the cost
of designing the rules over all the states and only charge
the people that are nonagreement for the cost of actually
administering their regulation and inspection. Whereas,
everyone is benefitting from the design of the guidelines.
CHAIRMAN JACKSON: So you are suggesting in that
that if everyone is benefitting from the design of the
guidelines, that that cost should be passed on to the
agreement states?
DR. PHILLIPS: That is what this -- yes.
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COMMISSIONER DICUS: Did you consider or suggest a
mechanism for doing that? Were you going to charge, for
example, the state -- what were the discussions?
DR. PHILLIPS: There was a discussion, it didn't
get into the final report, that one possibility, for
example, under Option D or E would be that the new agency,
whatever it is, might have a user fee for every user that
would cover the costs of doing that.
COMMISSIONER ROGERS: I thought you said that you
intended this should take place right away, even if there
wasn't a new agency. That under the present circumstances,
you would like to see that? That's what I heard; is that
correct?
MS. GOTTFRIED: Yes, that's true.
COMMISSIONER ROGERS: So it has to be a mechanism
that works under the present circumstances.
DR. PHILLIPS: Right, we did not get to the point
of designing that mechanism.
COMMISSIONER ROGERS: Not so easy to see.
MS. GOTTFRIED: Correct.
COMMISSIONER ROGERS: For agreement states.
Why should they pay? Send them a bill, thank you
very much, and they'll send it back to us.
DR. HENDEE: I don't think it is our
responsibility to figure out the mechanism. What is fair is
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fair here. We are trying to deal with what is fair to the
states in terms of the regulations that are proposed.
COMMISSIONER ROGERS: Well, that's fine but, you
know, reality is you have to do something about it and if
you want to make a recommendation that somebody fix
something, it is very helpful to have some thought go into
how you might go about doing that. We all like, you know,
ideal situations but sometimes we can't figure out a way to
achieve them.
CHAIRMAN JACKSON: Why don't you go on.
MS. GOTTFRIED: The next slide, please.
[Slide.]
MS. GOTTFRIED: The final area of recommendations
were made to the Conference of Radiation Control Program
Directors and to the states. The first of these
recommendations pertained to the CRCPD and that they
incorporate into their suggested state regulations for
control of radiation any relevant concepts from 10 CFR Part
35 that are not already integrated in those suggested
regulations.
Next slide, please.
[Slide.]
MS. GOTTFRIED: That all state legislatures enact
enabling legislation to incorporate the regulation of
reactor generated byproducts into existing state regulatory
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programs.
Next slide, please.
[Slide.]
MS. GOTTFRIED: And the final recommendation made
to the CRCPD and the states, that the CRCPD and the states
continually reevaluate their regulations and procedures
pertaining to radiation medicine to ensure congruence with
evolving scientific understanding of radiation bioeffects
and to be in accord with advances in knowledge regarding
benefits and risks related to medical and biomedical
research uses of ionizing radiation in medicine.
At this point, I would like to ask that we open up
for discussion among all the Committee members and that,
please, feel free to ask generic questions that anyone might
want to answer or target at particular Committee members.
CHAIRMAN JACKSON: Thank you very much,
Ms. Gottfried.
I am going to walk you through a series of
questions that I would like to get your responses to.
Could you provide more insights on why the
Committee, since we are talking about -- let's talk about
the alternatives that you considered, but in particular
focusing on Alternatives D and E, and I guess your report
indicates that Alternative E has all the advantages of
Alternative D but goes one step further by giving regulatory
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authority to the federal agency, whatever it is, any but the
NRC, in a situation of last resort.
Can you tell me a little more about the Committee
thinking in that regard and why you settled on Alternative D
in the end?
DR. HENDEE: We really debated many, many hours,
especially among C, D and E, and also to some lesser extent
F and there were many people who were on both sides of --
some people supporting C and some people supporting E and we
settled on D for the following reason, and let me just talk
about D and E.
Our experience as Committee members, and many of
us are quite experienced in the regulatory process, both
within agreement states as well as within the NRC, and what
we learned through our site visits and our public hearings
and through other mechanisms of collecting information,
caused us to believe that the process really could work,
really could work, without regulatory oversight at the
federal level and, in fact, does work quite well in many
areas at the present time with the CRCPD and guidance to the
CRCPD by various agencies such as the National Council on
Radiation Protection and Measurements and others. It really
works quite well.
We were worried that if, in fact, we were to
support or to recommend that a federal agency maintain some
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degree of regulatory authority over this process that it
would cause some states -- it would discourage some states
from fully participating in the process at the voluntary
level because the feds could always step in and we though
that the way to really make this work was to not have a
federal agency with some kind of last stopgap last resort
regulatory authority over the process.
CHAIRMAN JACKSON: Okay, well, let me follow on
with that. I mean, all of the alternatives, C through E but
the one you chose in particular, place additional regulatory
responsibility on the states and so my question is, what
degree of consistency or uniformity in regulatory standards
would be needed if the states were to regulate all ionizing
radiation and how then will that level of consistency and
uniformity be achieved given the different legislative
frameworks within which the regulatory processes within the
different states operate?
DR. HENDEE: Charles, let me answer that question
quickly but I know other people will want to answer as well.
For 90 percent of the radiation sources that are
used in medicine and biomedical research today, the NRC is
not involved in those processes and they are monitored and
regulated through a voluntary process or they are controlled
through a voluntary process, just the way we have described
Option D or Alternative D would work. So it is our belief
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and it is through our experience that we believe that in
fact there would be a large measure of uniformity for the
remaining 10 percent, just as there is today with the 90
percent that is related to machine-produced radiation and
naturally occurring and artificially produced radioactivity.
DR. PUTMAN: The other aspect of the uniformity
has to do with the significant role, not a superficial role,
that we see for DHHS. We listed eight, I believe there were
eight, roles and responsibilities to DHHS and we think the
collaborative and integrated approach there is very
important because a big part of it is collecting data,
education, assisting the states. We recognize that there
would undoubtedly be some states that, for a variety of
reasons, may not be as far ahead as some other states and so
there will have to be a mechanism in place to provide that
education and that was one of the reasons that we suggested,
of course, that DHHS might be the logical entity to do that
since they are so close to health care in a variety of ways.
DR. PHILLIPS: I might clarify a little bit what
you said about voluntary. I think what Dr. Hendee meant by
voluntary, for the 90 percent that is not NRC, it is done by
the states and of course these are individual state laws,
many of which follow that which were developed by the CRPD
but not mandated.
The other thing, the Committee looked at
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uniformity in two ways. One, we felt very strongly that we
need uniform regulation of all ionizing radiation. Not a
very strict regulation of one small component which we have
now, and perhaps less regulation of the 90 percent that is
left over on the other hand.
We should have a uniform, risk-based approach to
all ionizing radiation in medicine.
I didn't think the Committee felt that it had to
be absolutely uniform from one state to the other.
Regulation of medical practice varies from one state to
another as each state's people and government feel it should
be done for their people in their situation. And we felt
that that kind of variation was not unhealthy, that it is
part of the way things are done in this country.
CHAIRMAN JACKSON: What feedback did you obtain
from all the states in terms of their willingness or
capability to take on the roles, I guess.
DR. PHILLIPS: We did site visits, we were in
contact with the program directors, we heard from the -- I
mean, Kay could summarize all of the people who were invited
to come. We invited all of the states to come testify --
CHAIRMAN JACKSON: But in the end, how many states
did you actually --
MS. GOTTFRIED: Well, we spoke with a number of
the states when we attended an annual meeting of the CRCPD
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and got a variety of responses from the states in terms of
their -- whether they thought, in fact, state regulation
would be a good approach to dealing with these issues.
There wasn't any survey done of the --
CHAIRMAN JACKSON: There was no systematic --
MS. GOTTFRIED: Correct.
CHAIRMAN JACKSON: -- of each of the states?
MS. GOTTFRIED: Correct.
DR. PUTMAN: No.
CHAIRMAN JACKSON: So then my follow-on question
is, what assurances do you have in terms of the capability
of the states to -- to take on, you know, this additional
responsibility?
DR. HENDEE: Well, the states already have 90
percent of the responsibility.
CHAIRMAN JACKSON: Right. We are talking about
the 10 percent that you are suggesting they give up.
DR. HENDEE: That's correct.
CHAIRMAN JACKSON: So I am asking in particular
about that.
DR. HENDEE: We did not do a survey to ask that
question of all of the states but in the site visits that we
made, we discussed that issue, we discussed that issue with
various directors of state programs at meetings and the
feeling is that, in fact, this in many cases would allow
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them -- many of the responses were that this would allow
them to allocate their resources in a way that actually
would lead to improved uniformity and therefore improved
radiation control overall because, at the moment, in
agreement states, a good portion of their resources are
directed toward the 10 percent of radioactive byproduct
material in order to be in compliance with the NRC and
therefore a disproportionately small share of the resource
is allocated toward the remaining 90 percent of radiation
that they are responsible for.
CHAIRMAN JACKSON: Let me go on to talk about 10
CFR Part 35. The Committee is recommending that the NRC
initiate formal steps to revoke Part 35 in its entirety.
Does the Committee believe that the NRC could proceed with
this recommendation in the absence of congressional action?
DR. HENDEE: A lot of 10 CFR 35 is a matter of
enforcement and the level of enforcement and we believe that
the NRC could alter the intensity with which Part 35 is
enforced and make quite a significant difference.
CHAIRMAN JACKSON: If the NRC were to rescind Part
35 and without direction from the Congress, is there any
assurance that other agencies, for instance HHS and FDA,
would or could be authorized -- would be authorized to fund
it or willing to assume this additional regulatory
responsibility?
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DR. PUTMAN: John?
MR. VILLFORTH: No, I don't think we asked the
other federal agencies what they could pick up as a
responsibility and I think the transfer of that from the NRC
would be a congressional -- there would be a need for
congressional activity.
I also want to point out that the recommendation
was for 10 CFR 35.32 and .33. Not all of 10 CFR 35, the
immediate relaxation of the enforcement activity, which was
for .32 and .33 as it relates to the quality management and
the reporting requirements.
COMMISSIONER ROGERS: Do you have -- if I could
just ask one?
Do you have any measures other than seat of the
pants as to whether relaxation of our enforcement of those
sections would not lead to any diminution of public health
and safety, any?
DR. PUTMAN: David?
DR. GOODEN: I think we have some evidence in that
in that we did not see any particular difference in the
regulation of the 90 percent of radiation medicine. To
health effects there that reflects that portion of radiation
medicine, the byproduct material which is controlled by the
NRC --
COMMISSIONER ROGERS: Do you have any numbers, any
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quantitative data to support that statement that we found it
very difficult to get any kind of data to get numerical
values for the rates at which misadventures take place. One
can count the numbers but one doesn't know what the base is
on which those numbers come about. And one concern that I
have is that we don't have any measures here of exactly how
well people are doing. We have a lot of anecdotal
information and we have statements that people don't think
or do think this, that or the other thing. But it is very
difficult to get hard data and we are usually confronted
with, in our congressional oversights, with our being able
to assure the public that if we are relaxing some kind of a
requirement that there is no effect on public health and
safety.
And we have to have some basis to demonstrate that
belief and I am just asking you, do you have any suggestions
as to hard data that might support that other than just,
really, a kind of anecdotal collection of feelings of folks
that are not particularly convinced that those parts --
those sections of Part 35 are doing much good.
DR. PUTMAN: Bill.
DR. HENDEE: Mr. Rogers, we share your
frustration. We tried to look at this very, very hard. The
difficulty is that there is not very much hard, quantitative
data that either supports the need for Part 35 or would
. 29
support its not being present. It makes us believe,
however, that if in fact Part 35 really had a major impact
on reducing risk, then we would be able to see that and then
we would have measurable data.
So in the event that -- in the situation where
Part 35 addresses a situation where there is very low risk
to begin with, it really hasn't had much impact in producing
the risk and therefore our feeling is it will have very
little impact if it weren't --
CHAIRMAN JACKSON: This is reducing the risk
relative to what? I think the Committee agreed itself that
there is a lack of a database that compares reactor
byproduct material, you know, risk in terms of radiation
exposure there, with accelerator-produced or even naturally
occurring radiation and even comparing those to the risks of
other medical modalities.
So that is why I am asking, when you talk about no
net reduction in risk, it is risk with respect to what?
DR. HENDEE: I can only answer you back the same
way I answered before, and that is that we have no evidence
to suggest that there is any undue risk here associated with
the use of these materials and we have no evidence to
suggest that the implementation of Part 35 has reduced what
was already a very, very low risk in comparison with other
medical procedures.
. 30
CHAIRMAN JACKSON: But your Committee said that
you actually didn't have data to compare it to other medical
procedures?
DR. HENDEE: Other than just very limited, right.
DR. PHILLIPS: In radiation oncology there is some
data. There has been a series of studies funded by the
National Cancer Institute called Patterns of Care studies
that have registered all radiation delivery equipment for
therapy in the United States and looked at the process and
looked at outcome and they have information for cobalt
machines and for linear accelerators and there is no
difference in the complication rates.
Now, we consider serious complications as those
things that are reported. We can find no evidence that they
are less for cobalt machines which are regulated by NRC and
linear accelerators which are not. So that is on that
subset of radiation therapy patients but it is not a huge
number of diagnostic patients who get X-ray versus get
nuclear medicine.
DR. PUTMAN: Formerly, data was collected by CRCPD
not recently available. But as Dr. Hendee indicated, if you
look at the agreement versus nonagreement, through not solid
data but through the agencies, organizations within the
states, the medical societies, et cetera, there does not
appear to be any difference in the incidents between the
. 31
agreement and nonagreement. But you are right, we do not
have real, hard data except the data I guess about three or
four years ago from CRCPD.
MR. VILLFORTH: May I make an observation? That
we did look at one database and that was collected by an
organization outside of Philadelphia called the ECRI,
Emergency Care Research Institute, that collected some of
the FDA information for machine-produced radiation as well
as material that came in from the NRC and I don't think that
we found much. It was a very limited study.
CHAIRMAN JACKSON: Yes, how comprehensive was that
database?
MR. VILLFORTH: Well, it was as much as was
required to be reported to the Food and Drug Administration
plus any voluntary reporting that came in from other
sources, so it has limitations. Clearly, it has
limitations. But it was one database we looked at. It
wasn't particularly conclusive.
I would just make the other observation that in
terms of 10 CFR 35.33, as you perhaps know, the Food and
Drug Administration, as far as byproduct material in medical
devices, seals, sources and medical devices, does have the
intention, I believe, of moving ahead and incorporating
something analogous to 10 CFR 35.33 into its provisions of
the Medical Device Amendments of 1990. They would be
. 32
picking up the experience or duplicating, in effect, what
you are doing and what they are doing for all sources of
medical devices. This does not include nuclear medicine we
are talking about.
CHAIRMAN JACKSON: But this is not in place as
yet?
MR. VILLFORTH: This will be published for comment
in perhaps months and I don't think any of us have been
privileged to see the draft but I understand that is the
direction they are going and it would need to be looked at.
The point is that the Food and Drug
Administration, under its authority to the Medical Device
Amendments, for collecting data from users they have
traditionally had this responsibility of requiring
manufacturers to report but, under the recent amendments,
that has been transferred to users. I mean, the Congress
has passed that on to users so there is an analogue, to some
extent, of what you are planning to do or what you are doing
with what FDA is planning to do.
One could envision that the fallback position, if
the NRC were to pull out of 10 CFR 35.33, to use the
information that ultimately might be coming in to the Food
and Drug Administration. Again, as I understand it, this
does not include radiopharmaceuticals because that is not --
that -- drugs are separate from devices. I believe the
. 33
section that is in question is Section 5.19 of the code,
(b)(1)(B)(ii), which I don't understand, but somebody may
want to look this up and it reads that the Secretary or the
Commissioner has authority for other significant adverse
device experiences as determined by the secretary by
regulation to be necessary to be reported. I think that is
a result, perhaps -- the proposal for comment was probably
as a result of some collaboration between the two
organizations.
So this raises the question of whether there will
be some redundancy in the reporting.
COMMISSIONER ROGERS: Excuse me, does that
reporting give a base of patients treated and just as well
as the number of misadministrations or mishaps or whatever
you want to call them?
MR. VILLFORTH: There will be no denominator, to
my knowledge. That's the problem, that's the problem. And
I think until you have a denominator, you can't talk about
comparative rates.
DR. GOODEN: You might appreciate that the only
database that exists for misadministrations is the one from
the NRC. The rest of radiation medicine does not have that
type of database, personally, nor does most of other
medicine.
CHAIRMAN JACKSON: Do you think that such a
. 34
database need not exist?
DR. GOODEN: We talked about addressing that issue
in the report and maybe transferring that -- some of those
responsibilities to the federal agency that might give
oversight here. That it might be some wisdom in
accumulating some of that data. Maybe not under the same
premise as with the misadministration rule, but maybe under
some other parameters.
CHAIRMAN JACKSON: The last time the Committee, I
understand, addressed the Commission, it indicated that
there was no response from groups representing patient
rights. Do you now have input from groups representing
patient rights and how do you address the issue of whether
the patient rights will be adequately protected under your
preferred alternative?
MS. GOTTFRIED: We don't have any additional
information; that piece of information was elicited when we
went forward with our public hearing and invited comment and
testimony from any interested groups and we specifically,
because we were concerned about patients' perspective and
rights, focused attention on asking them to come and present
before us and none of the groups, and we have a listing of
the groups and the various organizations that we sent this
letter to, but we actually also called as well, they didn't
evidence an interest in coming to present; they didn't have
. 35
either the time, the interest or the resources, I suppose.
That was our supposition because they just, after several
calls, declined the invitation.
CHAIRMAN JACKSON: With respect to 10 CFR 35.32
and .33, is your beef with the rule or having a rule or is
it with how the rule is implemented?
DR. PUTMAN: Dave?
DR. GOODEN: I am not sure there is a beef with it
at all. I think the Committee evaluated this thoroughly and
found that the quality of management grew -- was unique to
the practice of medicine in this country. It did not exist
in any other place. And the Committee looked at this and
tried to determine whether there was justification of having
this unique parameter with byproduct material and I think we
determined that was not the case.
CHAIRMAN JACKSON: How did you make that
determination because doesn't it go back to the questions of
Commissioner Rogers and I asked of you in terms of the case?
DR. GOODEN: Of data? Data? There is a database
that exists with FDA and John may want to clarify this a
little bit but it has reporting of certain misadventures
also but those misadventures must cause serious body harm or
death to the patient.
There is nothing in medicine other than the
quality management rule that is a prescriptive dose-related
. 36
rule that requires reporting.
CHAIRMAN JACKSON: Why are you pressing
specifically on that in terms of immediate action, 35, 32
and 33, as opposed to having it done in a considered way as
part of an overall deliberative process on all -- you know,
all of your recommendations?
DR. GOODEN: Maybe someone else would prefer to
address that and I can --
MR. VILLFORTH: Well, I would make the observation
that there are ways you could do this. One extreme way
would be for Congress to do it. The other way is for NRC to
consider any changes through notice and comment rulemaking
or the NRC might wish to choose this by some regulatory
enforcement discretion as to how you implement some of these
activities.
If there are alternatives to trying to accomplish
the level of safety that you are concerned about, I think it
is real. In terms of quality, that can, perhaps, be
implemented through education as opposed to enforcement. If
you are trying to change the behavior of individuals which
is, to a large extent what you are dealing with in the
quality management rules, it is a process, it is a behavior
of the users and so forth.
That type of thing lends itself, perhaps, to
education and the leads that you have demonstrated already
. 37
by getting the rule out on the table is very important. The
question is, by pushing that to an enforcement environment,
has it gone too far and the reactions I think we have gotten
from the medical community is it has gone too far. It is
not so much that the concepts of quality assurance and
quality management aren't important; the question is, are
these behavioral types of things necessarily enforced -- to
be enforced.
CHAIRMAN JACKSON: But you are also recommending
that we eliminate the inspection part of it and the
inspection part of it relates to a database, in fact. I
mean, it helps.
MR. VILLFORTH: I am not sure that will give you
the denominators that you are talking about other than the
number of facilities. I am not sure I understand.
CHAIRMAN JACKSON: Well, the point is I am lost
because I don't see other mechanisms that have been
proposed.
MR. VILLFORTH: Education --
CHAIRMAN JACKSON: That is not gathering data.
See, what we are interested in, what I am
interested in, is regulation as it relates to risk and if we
want to make an assessment of risk relative to whatever the
denominators, if you want to flip it, the numerators are,
the point is that that database has to exist.
. 38
The question is, how does one get at it.
MR. VILLFORTH: Can I ask a question back to you?
CHAIRMAN JACKSON: You can ask me whatever you
would like.
MR. VILLFORTH: I guess we are as confused about
Part 35 as you seem to be, in the following way.
CHAIRMAN JACKSON: I am not confused. I am
confused about your recommendation relative to Part 35.
MR. VILLFORTH: Our recommendation is based on the
fact that it is true, we don't have as substantial a
database to look at the issue of risk as it relates to Part
35 as you might wish. But we also know that you don't have
it.
It seems to us that one should develop regulations
based upon the identification of a risk that regulations are
to address and not based upon a hypothesis that then you ask
us to develop a database in order to do away with the
regulation. It seems to me the regulation ought to be --
depends more on the database than anything else.
So, you know, quality, the quality of management
part of Part 35 is what we do every day in the practice of
medicine. We are all very concerned about total quality
improvement, about quality management practices. I don't
think we need regulations to try to force that issue on us.
We have to do that in order to compete effectively in a
. 39
managed care environment to begin with.
So I would like to ask the question back to you --
CHAIRMAN JACKSON: I am going to ask the question
of Dr. Paperiello --
DR. HENDEE: Okay, what is your database --
CHAIRMAN JACKSON: -- since he is here, and have
him go to the mic and speak to the issue.
DR. PAPERIELLO: Yes.
[Laughter.]
DR. PAPERIELLO: What is the precise question?
CHAIRMAN JACKSON: How can you help us get at this
issue having to do with issues of this quality management
rule, the database on which it rests and the need for having
data relative to the risks we are trying to address?
DR. PAPERIELLO: Well, we have the -- we know the
number of events. It is true we don't know the denominator.
In a report I gave to the Commission a couple of
years ago, I used data that Dr. Pollycove gave me as well as
data that the NCRP had put out in terms of the number of
procedures because they were similar. And I gave the
Commission an order of magnitude estimate which I believe
was one in 4,000 or one in 6,000 procedures.
Now, if you really want the denominator, you would
have to require our licensees, I believe, to provide us --
report the information and do it on a very well-defined
. 40
basis because, for example, high dose rate brachiotherapy is
a different encounter than low dose brachiotherapy or
fractionated external beam radiation.
The path -- the failure is going to be different
so you can't assume the error rate in one form is going to
be the same as the other. In low dose rate brachiotherapy
you have one encounter with the sources, in high dose rate
it is fractionated two or three times. In teletherapy you
might have 20 fractions and in nuclear medicine, your
radiopharmaceutical, it may only be one. And so if you
really wanted precise data you would have to have the
licensees report. Then you would know the failure rate for
those licensees as well as the administration rate. My
opinion.
CHAIRMAN JACKSON: Thank you.
DR. PUTNAM: We did indicate that there was a
political issue that DHHS or -- that happened to be the
agency we suggested would take this responsibility on. Also
with rates, one of our concerns is adverse effects from low
treatment or low dose treatment when high dose treatment is
more appropriate, and that becomes even more complicated and
maybe Dr. Phillips could respond to that.
DR. PHILLIPS: I think I might say something about
the whole problem.
We talked a lot about the need for a database for
. 41
the denominator to be part of it and aside from this pattern
of pattern of cure study I have mentioned there really isn't
any denominator data.
There are ways to get at it. I mean HCFA has
information at least on the Medicare population on billings
and all of the different codes that would describe whether
it is HDR or LDR or what nuclear medicine procedure, so for
that population I think it is possible to get at the
denominator and with reporting through FDA or whoever of
significant incidents I think we could come up with that
information. I personally think it is an important thing to
do and I agree that we don't have the information right now
that would answer the question.
I just want to make a comment on the quality
management. It is part of the requirements in every
department because of the hospital accreditation that you
have to have a very clearly defined quality management
program. It was felt that a lot of the things in 35 require
you to do excess documentation and repeat what you are
already doing and being inspected for within your hospital
and reporting every month every incident to our quality
management committee, so that it's a redundant system at the
present time and that is why it was felt to be onerous.
Did I answer your question well enough?
CHAIRMAN JACKSON: Thanks. Commissioner Rogers,
. 42
do you have some additional questions?
COMMISSIONER ROGERS: Oh, well, really just a very
general one I think. You have made it very clear that you
believe that at least some of NRC's regulations are unduly
burdensome. I think we just heard that, but the question is
really for us -- that's important but the fundamental
question is have they adequately protected public health and
safety or not?
One of my concerns with your report is that it
doesn't seem to address that issue of whether NRC's
regulations and its procedures which involve all of the
regulatory paraphernalia, good and bad, that we have has
adequately protected public health and safety in this area or
not.
The whole -- not the whole but one of the reasons
why we embarked on this study is really because there were
some very serious questions raised and I think you even
pointed that out in your study by Congressional committees
as to whether NRC's regulations in fact were protecting
public health and safety in this area, and there was a great
deal of hullabaloo about it and newspaper articles and all
sorts of things, and what we had hoped we might be able to
learn along with other things, other good things that you
have done here, is whether you have come -- you could come
to any conclusions as to whether even though they may be
. 43
burdensome and unnecessarily burdensome, and I am not mixing
that issue in, whether they in fact have adequately
protected public health and safety or not, and whether they
have fallen short on that account.
I would like to hear a little bit from you on that
score.
DR. HENDEE: I would like to respond to that. Let
me first, before I do, say that some of the most well-
publicized cases such as the one in Indiana, Pennsylvania
that we all know about, really does not reflect anything
that the regulatory process can do much about.
It is very hard to regulate against ignorance.
It's hard to regulate against stupidity and it's hard to
regulate against intentional wrongdoing. Some combination
of those factors were responsible for what happened in
Indiana, Pennsylvania, and that is more often the case than
not in the dramatic, well-publicized cases.
They oftentimes escape any kind of regulatory
process, as you well know.
I believe in fact, and I think many members of the
committee believe that the NRC process has interfered with
the maximum risk reduction that could be achieved otherwise
for the following reasons.
It concentrates on only 10 percent of the total
usage of radiation in medicine and yet it captures almost in
. 44
many institutions the complete attention of the people that
are responsible for radiation safety because it is so
burdensome in terms of paperwork and in responding to the
inspection process and to the enforcement process.
In my own institution I can tell you that's the
case. Our radiation safety office spends almost all its
time dealing with 10 percent of the issue and very little
time dealing with 90 percent.
It is the uniformity problem. We need to find a
way to develop a more uniform approach to the control of
radiation, to the wise use of radiation in medicine overall
and I think we would all agree to that.
Now the problem with that is that is now
superimposed on a second problem, and that is the problem of
allocation of resources, and we all know what problems
health care institutions are going through these days, so
the challenge is how do we develop a more uniform approach
to the safe and wise use of radiation within the constraints
of the limited resources to achieve that that we all have,
and we believe that in fact the way to do that is not to
escalate everything else up to the level that the NRC
currently enforces the regulatory process on 10 percent, but
is to take a wiser and more reasoned approach in a uniform
fashion through the appropriate allocation of those
resources that we have to look at the overall issue, the 100
. 45
percent usage, and our report really reflects what we as a
committee believe is the way to achieve that and it is
through the process that is described by Alternative D.
DR. PHILLIPS: I think, Commissioner Rogers, we
did address the question of has the program worked. Now we
obviously can't say that the very low incidence of
significant occurrences that's outlined on page 119 is
definitely due to the NRC, but we can certainly say whatever
the system is -- the states, the NRC, the whole system --
these events are very rare both in diagnostic -- like .002
in NRC states and .00012 percent in agreement and
nonagreement for diagnostic procedures. That is much lower
than any other event that has been documented in medical
drug administrations, for example, and it is extremely low
in therapy as well -- .002 percent -- taking all the
agreement and nonagreement states.
So I think that something is working. The present
system is working in the sense that it is keeping the
incidence and diagnosis in therapy low, but it seems to be
as low in the agreement states as in nonagreement states and
it seems to be low from what limited data we have for the
non-byproduct applications, so I think that we have to stop
at that point.
COMMISSIONER ROGERS: I have a couple of things
that I would like to just explore with you.
. 46
In stating that Federal authority would be
maintained in one of your slides you said the FDA would
continue to regulate the manufacture and labelling of
radiopharmaceuticals and medical devices.
Have you thought at all for example of who would
deal with the regulation of activities involved with boron
neutron capture therapy, which really involves a reactor?
Have you -- I know that is a little special area right now,
but it might be an example of what your thinking is on this.
That seems to be one that doesn't quite fit into any of
these nice little boxes that we have here.
DR. PHILLIPS: No, it doesn't, but I think --
VOICE: Cigarettes today, reactors tomorrow.
DR. PHILLIPS: I think our feeling was that should
stay with NRC because it is so closely related to reactor
operation. I mean it's not separable -- using the beam from
the reactor and I don't think that could be separated out.
COMMISSIONER ROGERS: Well, you are recommending
that there be some kind of a wonderful Federal oversight
that is to accomplish a number of things but it will not be
regulation. The regulation will be through the states, and
that the Federal oversight will be there to assist in
various ways, to promote good practices, develop
regulations, collect data and so on and so forth, but won't
really have any authority as such -- at least -- I don't
. 47
know. I mean you haven't made it clear I think as to
whether it would or not, and I think we all know that in
these days, and they probably aren't going to go away very
soon, of constrained resources, that very often the only way
that a Federal agency is going to get full participation is
if it has some teeth.
I know from many, many times, if I can be
permitted to refer to the reactor area, which is a different
one but nevertheless it has some lessons in it, I know very
well that many of our licensees have said, you know, we are
very grateful that NRC has required that of us because if it
wasn't required our Public Utilities Commission probably
would disallow it as a cost, and yet we think it is a good
thing to do.
I am afraid that that kind of situation can easily
occur here if there is a Federal agency which is trying to
do a good job but doesn't -- I mean particularly if you are
talking about the collection of data because the collection
of data costs money -- and that is one of the problems. One
of the QM problems, rule problems, is that it is costing
money and time and resources to do that and I frankly
wouldn't give very much hope for a Federal agency that said
please send us your data -- we need it for our database. I
don't think that will happen. It will happen some places;
in other places it won't. States that have tremendous
. 48
financial problems are going to say, well, can't really do
that this year, and then you have got a gap in your database
and so I just wonder whether you really have tried to think
about the realities of what that recommendation would carry
with it.
I don't think that -- maybe I'm wrong here, but I
don't think in matters that involve health and safety and
cost money that a Federal agency that has no authority is
going to get very far.
DR. PUTNAM: I think I would have obviously agreed
with you more five years ago. I do understand where you are
coming from.
I think we are looking, truly at a different
paradigm as it relates to health care delivery and the issue
of where Medicare and Medicaid is and the longitudinal
databases that are going to be required to make a lot of
decisions in health care -- utilitization costs, cost
effectiveness, long term results, et cetera, so I think it
will be simpler to put the data or collect the data that we
are going to need into that database.
Obviously the relationship between the Federal
government and the states as it relates to Medicare and
Medicaid still has yet to be worked out.
I think though that the managed health care or the
managed care corporations are those that are going to be
. 49
responsible for health care in the private sector need this
database.
You can collect it related to adverse reactions
but you really need it over the decisionmaking for
reimbursement of those procedures, technologies that
currently are being reimbursed and not really being perhaps
assessed. That is a total different issue than what we are
talking about, but one question is --
COMMISSIONER ROGERS: It may be a way of getting
the data.
DR. PUTNAM: It may be a way of getting the data.
Do we need to do all these things and so I think that is
more likely now than it was a few years ago. John?
MR. VILLFORTH: I just want to make an observation
about your saying that -- the difficulty of getting an
agency, whoever it might be, to do these good things without
some resources or support or a big stick or money or what
have you.
I think one would need to go back and look at the
history in the 27 years that the Conference of Radiation
Control Program Directors has been around and look at the
accomplishments that the states have had in protection in
terms of machine produced radiation over the years, which
was done without any mandatory requirements on the part of
the Federal governments, without anything more than the
. 50
attempted assistance, whether instrumentation development,
the ability to try to assist the states in processing data
that might come in voluntarily -- all sorts of advice and
cooperation and so forth, and that was done without money
flowing to the states for that particular purpose, and I
think if you look at the accomplishments in terms of what
has been done to correct deficiencies of machines, radiation
producing machines particularly in medicine, in that period
a lot has been done without a big stick, without a lot of
money other than the staff at the headquarters that may have
been involved with developing instruments and data
processing and so forth from a voluntary standpoint.
Nothing was passed on to the states to accomplish
so I think if there is leadership -- and again, resources
are tighter now than they were 27 years ago and it is more
difficult, states have more pressures put on them -- but in
principle I think that those programs at the state which are
concerned about public health -- the Commissioner of Health
of those states is concerned about safety of his or her
citizens -- those sorts of programs have evolved and can
continue to evolve and I am not so sure that they wouldn't
happen in the program that we have outlined, but it does
need a spark, leadership, and the willingness to work in an
educational environment with the states. That is I think
where we are coming from.
. 51
CHAIRMAN JACKSON: If a state decided that it
didn't want this responsibility, is that acceptable to your
committee -- and there is no Federal agency that really has
a real authority with teeth, as Commissioner Rogers would
say -- is that satisfactory to your committee?
MS. GOTTFRIED: Do you mean the responsibility of
expanding their existing regulatory system --
CHAIRMAN JACKSON: That's right.
MS. GOTTFRIED: -- to include byproduct materials?
CHAIRMAN JACKSON: That's right and they have
decide they didn't want to do that.
MS. GOTTFRIED: I think that the committee felt
that it was a state's prerogative, in fact they wouldn't
have access then to byproduct materials so in fact there is
a -- there is not an opportunity to actually come in and
assume responsibility for that state but there is some, for
lack of a better word, punitive approach to dealing with
those states that would not expand their existing programs.
CHAIRMAN JACKSON: So given that, then why is this
not an unfunded mandate that you either, you know, take it
on and you pay for it or you can't have the goodies?
MS. GOTTFRIED: Because there is a sense that the
states would want to appeal to a uniform approach to
regulating radiation in medicine and although it's only -- I
guess one of the things the committee kept on coming back to
. 52
is it is such a minute area of radiation medicine in
particular. We are talking about 10 percent of radiation
medicine, and then you are talking about radiation
medicine --
CHAIRMAN JACKSON: You're doing it, you mean, on
an activity basis not a risk basis necessary?
MS. GOTTFRIED: Correct.
CHAIRMAN JACKSON: Or both -- but we have already
been talking about data, so --
DR. PHILLIPS: Yes. We don't want to get back on
the data argument.
I think it's not exactly unfunded because the
states currently fund their programs from license fees and
user fees.
MS. GOTTFRIED: User fees.
DR. PHILLIPS: And they would certainly be able to
fund this new responsibility that same way, so you are
giving them the opportunity to charge for what they have to
do.
MS. GOTTFRIED: I think one of your major
questions is if -- I'm sorry -- that if in fact we allow the
states to make that determination as to whether or not to
incorporate byproduct material, would the people in that
state be at some disadvantage or unprotected, if you will,
and that the states have the prerogative to determine what
. 53
areas they want to focus their attention on and in many
respects I don't think we will learn the answer to that
unless we give the states the opportunity to assume
responsibility for this area of regulation and I think the
whole issue -- we discussed this at the last meeting we were
at -- that whole cost-benefit --
CHAIRMAN JACKSON: Different Commission.
MS. GOTTFRIED: Correct -- absolutely -- two-
thirds different, one-third constant -- there is this whole
issue of a cost-benefit analysis and how much in terms of
resources need to be expended for what kind of a return and
what return are we presently getting and given the
unfortunate circumstances that many states are in with
respect to allocation of resources, don't those states have
the prerogative to make a determination as to where there
resources ought to be focused.
CHAIRMAN JACKSON: But you didn't ask them all.
Commissioner Dicus.
COMMISSIONER DICUS: Thank you. I have two or
three questions or comments. I am not sure based upon just
the exchange we have just had, you may have as good an
understanding of the ability of the states to do this in
terms of the resources that they are going to have available
to them. There are some states that this may not be a
problem. You know, they may be able to go to the fee
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structure. They may be able to change their fee structures,
but for many states this is a problem. It is very difficult
to do because they are competing with all the other -- the
radiation protection program may be competing with all the
other programs with their state legislatures to get these
funds.
Let me ask a question and go back to the issue of
uniformity -- and I think you are aware of this. Within --
and I am not talking about medical practice differences -- I
want to talk about radiation protection programs'
differences, there are variances now -- agreement states or
nonagreement states within theme. There are variances in
we're talking about whether it is a materials programs or
the norm program or strictly just X-ray program.
The variances not only may be in the rules
themselves, but the variances may be in the program and the
implementation of that program and the resources that people
have available, that the human resources, the level of
training, the level of expertise.
There are even differences within states. There
are states where say the X-ray program is in one state
agency and the materials program is in another state agency,
and those two agencies have inconsistencies.
I am not clear as I look at this, I am not clear
where the process that you are recommending might really
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change that and perhaps you could give me a little bit more
background on your discussions that you think that a new
Federal agency providing guidance can change this and under
what authority? I mean how will it do it?
MR. VILLFORTH: I don't think -- I was going to
say that I don't think that one could predict how it would
be changed, and you described I think perfectly the
diversity that presently exists.
I think the success of that program has been
through the suggested state regulations and the fact that
the states have worked together with their counterparts at
the Federal government and their colleagues in the states to
come up with whether it is non-ionizing or whatever
regulations and have come up with what is sort of a
consensus that this is the best way that the regulations
should be prepared.
Then I think we recognize the reality is, that
some states won't adopt those regulations. Some may not
have any. Some may go even farther and become more specific
in their regulations. I think the important thing is though
that one comes out with a good regulation -- suggested state
regs as the blueprint or the model and allow the states then
to modify that as they see fit.
If State X wants to be more aggressive and go
beyond that, that's their option. If they want to drop back
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and become more relaxed, that is their option too, and it is
done obviously through the regulatory process at the state
with the input from the citizens, the consumer, the patient,
the medical profession and so forth.
As far as the other point that you have raised,
which is a reality and that is not only are the regulations
on the books reasonably good and appropriate, consistent,
but is the implementation -- is the enforcement of that in
one state extremely aggressive, in another state
particularly lackadaisical and how does one calibrate that?
I think --
COMMISSIONER DICUS: That can affect this database
that we want, too.
MR. VILLFORTH: Well, I'm a little confused about
the idea of using regulations to collect data, personally.
CHAIRMAN JACKSON: We do it all the time.
MR. VILLFORTH: I have problems with that. I
think -- I mean I would hope the regulations would be used
to solve a problem and the problem would be public health --
CHAIRMAN JACKSON: Well, the database is an
important part of that. I mean let's not lose sight of
that, that you cannot quantify and understand risk --
MR. VILLFORTH: I understand.
CHAIRMAN JACKSON: -- without information.
MR. VILLFORTH: But if -- well, I won't -- we need
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a beer some time to talk about this.
[Laughter.]
MR. VILLFORTH: So there certainly is the range of
how this will be implemented but I think the checks and
balances are at the state level in concert with the medical
community and the patients and the citizens and the state
legislature.
I think our feeling was that this is the place to
start and that one could recognize that those variations
would be acceptable within the state framework based on
resources and the state's personality and so forth.
DR. HENDEE: Let me follow up with one other
comment and I wonder if this is also true in your
experience.
It is true that right now there are some states
that are much more vigorous in their enforcement of non-NRC
types of regulations over radiation than are some other
states. New York and Texas come to mind as especially
vigorous enforcement states.
I think it is also true though that in spite of
the rather wide variation from state to state in looking at
the non-byproduct material types of regulation and
enforcement that there is far less variation in the
institutions from one state to another, and that is because
the use of radiation is governed not simply by what some
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agencies, some regulatory agency says you can and cannot do
but it is much more governed by a variety of voluntary
accreditation processes such as the Joint Commission on
Accreditation of Health Care Organizations and those types
of responsibilities and even more importantly through the
professional societies and the members of those professional
societies that practice in those institutions, so in fact if
you compare two states, one that has a very vigorous X-ray
inspection program and another that has a much more laid-
back X-ray inspection program, great differences in the
level of enforcement, and yet when you look at the use of X-
rays, either diagnostically or therapeutically, in terms of
their medical applications, you will find a pretty
widespread uniformity across those two states because the
way the radiation is used, monitored and controlled and the
way the risks are minimized is pretty consistent because
that is a reflection of the professional activity and the
non-regulatory mechanisms that are in place already.
COMMISSIONER ROGERS: Yes, in the institutions, I
would agree, but not from -- necessarily from individual
practitioners. I see enormous variations. In the
institutions, the professionals in the institutions belong
to professional societies, as you say. They meet with each
other, exchange information. They check on each other in a
sense. They act as a check on each other and what is good
. 59
practice is well recognized and that is the environment in
which they work and that just sort of transfers around.
That is the network, the professional network.
But then if you start to look at individual
practitioners that may have an X-ray machine or something or
a cobalt source that might vary enormously from state to
state, depending on how vigorously the state enforced
radiation protection regulations.
DR. HENDEE: Well, I think we would have to have
some discussion of that and neither one of us has enough
data to really be able to verify our position but that
variation may be much less than we are led to believe and
certainly the social pressures on those individual
practitioners are such that if they are doing things that
are out of the mainstream, they are certainly going to be
encouraged to come into the mainstream, if nothing more than
just on a competitive position with regard to their
providing health care services.
COMMISSIONER DICUS: One other point. To go this
route we are looking at either creating a new Federal agency
or creating a new branch or part of an existing Federal
agency and obviously there are costs associated with that.
Likewise, looking realistically at the potential
at least of some more -- 50 plus radiation protection
programs at the state level having to have statute
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modifications and certainly perhaps regulation modifications
and adopting new regulations or revising regulations is
time-consuming and it varies of course from state to state
depending on their administrative processes, but it is also
extremely costly. It can run into the tens of thousands of
dollars just to modify a regulation in real money as well as
in the resources needed to do that.
When you have to take your people to do this, your
people are not doing other things, so my question is did you
calculate the costs and what are they and who is going to
pay for it?
DR. PUTNAM: No, we did not calculate the costs.
Clearly in many of the states we think they
probably do have the process in place. It is still additive
but many of the states that have essentially taken over much
of the responsibility for the basic aspects of radiation,
this probably wouldn't be too excessive.
There indeed are states though, as we have said,
that are going to need more, but we have not calculated that
cost.
DR. PHILLIPS: Let me point out there that the 29
agreement states already have these programs so that this
should not be any additional costs for them and those are
most of the big states population-wise so that the net
cost -- you know, we didn't do a formal calculation -- would
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only be to those states that are non-agreement and in the
long run the costs that the users would save if we agree
there is some over-regulation now and the fees that would be
paid to the state hopefully lower than currently paid to the
NRC, would make up for any additional costs.
COMMISSIONER DICUS: But even agreement states may
find that they have to do some statute changes.
DR. PHILLIPS: Yes.
COMMISSIONER DICUS: Or some regulations, so they
will have some costs.
CHAIRMAN JACKSON: I'd like to thank each of you,
each member of the committee today and its study staff for
your briefing and your report. It's been a truly
stimulating discussion and it is clear that you have devoted
many hours to the effort.
The issue of NRC's regulatory role in the medical
uses of byproduct material is not a simple or a trivial one
and the committee's report however will be of tremendous
benefit to us in enabling the Commission to fully evaluate
the merits of the various regulatory regimes for regulation
and for use of byproduct material in medical uses.
Rest assured we will give careful and serious
thought to your report as we deliberate and the committee
and the study staff are to be commended for a product that
advances our decision-making process in this important area
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and we really appreciate your efforts.
COMMISSIONER ROGERS: Thank you very much. We
appreciate it.
MS. GOTTFRIED: We would also like to thank the
NRC Staff for providing us with a lot of information during
the course of the two years and appreciate all the
assistance provided.
[Whereupon, at 3:29 p.m., the briefing was
adjourned.]
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