ML20033G223
| ML20033G223 | |
| Person / Time | |
|---|---|
| Issue date: | 03/28/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| NACMUI, SECY-90-117, NUDOCS 9004060278 | |
| Download: ML20033G223 (4) | |
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POLICY ISSUE.
I March 28, 1990 S' '-9 7
(Notation Vote)
For:
The Commissioners From:
James M. Taylor Executive Director for Operations
Subject:
SECY-89-263 - ROTATION OF MEMBERSHIP, ADVISORY COMMITTEE ON THE MEDICAL USES OFIS0 TOPES (ACMUI)
Purpose:
To respond to the Commissioners' request, in a Staff Require-ments Memorandum dated October 5,1989, that the staff consider expanding the membership of the ACMUI.
Background:
The Commissioners approved the staff's recommendation to-appoint certain individuals-to the ACMul. The Commissioners also asked the staff to determine whether the ACMUI member-ship should include public interest groups, the' O.S. Public I
Health Service, the Food and Drug Administration (FDA), and the States.
The Commissioners requested the staff to then:
solicit additional members or to explain why such membership-is not needed.
Discussion:
Current composition.
The current charter of the ACMul I
stipulates that Committee members may advise the staff on the development of standards and criteria for regulating and i
licensing uses of radionuclides in human subjects.
In-i dividual members of the ACMUI also provide advice and j
consultation on user qualifications and the medical use of 4
radiation sources.
Historically, the composition of the ACMul was designed to ensure that the staff had access to a. group' of medical practitioners who, collectively, had broad, in-depth training and experience in radiation medicine.
Members' experiences 1
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Contact:
NOTE:
TO BE MADE PUBLICLY AVAILABLE F. A. St. Ma ry
'WHEN THE FINAL SRM IS MADE 492-0611 AVAILABLE 1
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lThe Commissioners 2-1 include medical specialties _ such as diagnostic nuclear -
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medicine, therapeutic nue.1 ear. medicine, sealed source
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l radiotherapy, medical _ physics, and other related medical q
specialties consistent with the medical and' scientific; background needed to address technical. radiation = safety issues whose complexity is compounded-by the potentialiimpact on medical services available to the public.
The composition of the ACMUI was changed from time to time to address energing issues and medical use advances.;
Based on the expanded role technologists play in ~providing patient care and implementing; radiation safety programs, the staff recently recommended expanding.the technical-_ base of the ACMUI by the addition;of a -technologist. _ Because medical practice varies across the' country, members have been chosen to ensure geographical balance., Approximately hal f-the.
membership-comes from Agreement States., Membership is also l
balanced by spanning a cross-section of types of. practices, i.e., from small community' hospitals to -large medical-research institutions.
The staff believes that balancing 'these key parameters (specialty, type and size of practice, location, and State.
regulatory program)~ ensures that the ACMul can provide L _
technical guidance that takes into consideration a broad range of'needs and resources; _ This is consistent with.the-technical focus for. the memberships of the ACRS'and the 'ACNW, Di f fering perspectives on issues. A number of viewpoints on medical care can assist in establishing an appropriate' regulatory framework.
These include.the perspectives of patients' rights groups, other Federal service and requiatory agencies. Agreement State and non-Agreement. State radiation control agencies, andlexpercs in medical care.
The staff recognizes that a variety of groups and organiza-tions should play a role in-the development and implementa-tion of the U.S. Nuclear Regulatory Commission's (NRC's) regulatory program governing medical' use.
For example, the staff maintains day-to-day contact with FDA and is currently working with FDA staff to develop a resolution to the Society of Nuclear Medicine (SNM). petition for rulemaking regarding the practices of medicine and pharmacy.
The Agreement States l_
are asked to comment on draft regulatory initiatives when they are circulated for internal comment.
The public comment period required by the Administrative Procedures Act provides u
an opportunity for any individual or organization to comment on NRC initiatives.
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J The Commissioners
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E Regardless of the makeup of this basically technical comm mittee, the staf f would continue'to obtain information from-j
.any other groups that:may have interest enough to comment:
through the public comment process associated.with rulemak-a ing.
We would like to note that, unlike.other uses of 1
radioactive materials, there are no public advocacy groups j
which have expressed views opposed to.or critical of certainE
! aspects of medical use.
Impact of expansion.
There are pros 'and cons on the expan-sion issue.
Expansion of the:ACMUI could help ensure that'-
its deliberations included not only technical perspectives, i;
but also patient rights and State control perspectives.
It could help ensure that'NRC's technical ~ deliberations were coordinated with State and Federal-regulatory and service q
programs.
For example, one _could consider adding a personL l
from the FDA, the Health: Care Financing Administration-(HCFA), or a state board of pharmacy, in that an. issue.
relating to these groups couldLarise.. However,lmore exten-sive involvement would be needed with thes management of such organizations themselves than'can be obtained through a-single member being on the' Committee.
As mentioned earlier,-
NRC and FDA staff have extensive interactions.. We are'also developing a relationshipiwith HCFA'and the National,.Associa--
tion of the State Boards of Pharmacy.
However, such an expansion 'would change the. fundamental-character of the Committee..from one of technical. experts -to representatives of affected groups;'this would present certain dif ficulties.- In particular, the technical-- content of the meetings would be diluted, defeating the very. purpose L
for which the Committee was created. -In addition, expanded-i representation could make the Committee too large for l
meaningful deliberations.
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In addition, expansion of:the ACMUI.could lead 'to the ineedLto-l establisht a permanent support staff similar to: that which i
supports the ACRS and ACNW..This' would depend upon the role, j
the frequency of meetings,'the issues, and the depth of L
review that the Commission would expect' the ACMUI' to conduct.
Conclusion.- The staff recognizes'the difficult line to be drawn between a committee that is concerned with the applica--
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tion of scienti fic and technical > knowledge and one that provides policy advice as outlined in.the Commission Paper-entitled " Membership, Advisory Committee on the Medical Uses of Isotopes, SECY-90-017," from Willian C. Parler, General Counsel.
On balance, however, the staff' believes that the current structure of the ACMUI best serves NRC needs for a committee, and that viewpoints of affected groups are better -
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- The Commi ssioners ;
obtained through other available mechanisms.
The. staff believes that the current makeup of the Committee-is not inconsistent with Mr. Parler's memorandum.
Recommendation:
The staff recommends that the composition of the ACMUI be maintained and that the membership not be increased further.
1 j
p[ _
James M. T or xecutive irector for Operations Commissioners' comments or consent should' be provide'd directly.
to the Office of the Secretary by COB Friday, April 13, 1990.
i Commission Staff Office comments, if any,: should be submitted =
to the Commissioners NLT Friday, April 6, 1990, withtan infor-mation copy to the Office of the Secretary.
If the. paper is.
of such a nature that.-it requires additional time for analytical-review and comment, the. Commissioners and the Secretariat-should be apprised of when comments may be' expected.
DISTRIBUTION:
Commissioners OGC L
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GPA EDO SECY h
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