NUREG/BR-0309

Serving on the Advisory

Committee on the

Medical Uses of Isotopes

(ACMUI): A Member's

Guide

U.S. Nuclear Regulatory Commission

Office of Nuclear Material Safety and Safeguards

Washington, DC 20555-0001

I
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NUREG/BR-0309

Serving on the Advisory

Committee on the

Medical Uses of Isotopes

(ACMUI): A Member's

Guide

Manuscript Completed: February 2004

Date Published: March 2004

Prepared by

A.R Williamson

Division of Industrial and Medical Nuclear Safety

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Washington, DC 20555-0001
Abstract

The Advisory Committee on the Medical Uses of Isotopes (ACMUI) provides a valuable

service to the staff of the Nuclear Regulatory Commission (NRC) through the advice

and recommendations it gives staff.

To be able to advise staff effectively, it is important that the ACMUI have a basic

understanding of its role and its responsibilities. Likewise, it is also important that the

committee have a basic understanding of NRC processes and requirements. Such

understanding creates an environment where the ACMUI can effectively advise the

NRC staff. Effective advice, in turn, serves patients, the public, and the medical

regulated community by helping the NRC staff develop regulations that promote safety

and are useful, realistic, practical, and not overly burdensome on NRC medical

licensees.

iii
CONTENTS

Abstract................................................................................................................. iii

ESTABLISHMENT AND PURPOSE OF ACMUI

Establishment of ACMUI ........ 1.............................

Purpose of ACMUI ............................................... 1

INTERACTION BETWEEN THE ACMUI AND THE NRC STAFF

Working Relationship Between the NRC and the ACMUI .................................... 2

Nature of the NRC and the ACMUI Interaction ............................................... 2

The Designated Federal Official and the ACMUI Chairman .................................. 2

Open Session and Closed Session Public Meetings .............................................. 3

ACMUI Compensation and Conduct ............... ................................ 3

INTERACTION BETWEEN THE ACMUI AND THE COMMISSION

Purpose of Commission Briefings ............................................... 5

Briefing the Commission ........ 5..............................

Outcome of ACMUI Commission Briefings ............................................... 6

STAFF HANDLING OF ACMUI RECOMMENDATIONS ......................... 7

TYPES AND PURPOSES OF ACMUI EVALUATIONS ........................... 8

References .............................................. 9

v
ESTABLISHMENT AND

PURPOSE OF ACMUI

ACMUI'S Establishment

The U.S. Nuclear Regulatory Commission (hereafter, the NRC or Commission)

established the Advisory Committee on the Medical Uses of Isotopes, or the ACMUI, in

1958. The'ACMUI was established under the authority of the Federal Advisory

Committee Act, and is executed under the provisions of 41 CFR Part 102, "Federal

Advisory Committee Management", and the'NRC's regulations contained within 10

CFR Part 7, "Advisory Committees.'

As an advisory body that the Commission established for the express purpose of

advising the NRC staff, the ACMUI provides advice that helps staff create medical

regulations that are useful, realistic, practical, not overly burdensome, and not

inappropriately intrusive in the practice of medicine. The ACMUI furtherassists the

NRC staff by providing technical assistance in licensing, inspection, and enforcement

cases; providing consulting services when necessary; and by bringing key issues to the

attention of NRC staff for appropriate action.

The Commission has other professional advisory committees in addition to the ACMUI,

and these other advisory committees may differ from the ACMUI somewhat in the

manner in which they were established. For instance, the Advisory Committee on

Reactor Safeguards (ACRS) was established by statute in the Atomic Energy Act of

1954. This is the only advisory b6dy at the NRC that was established by statute,

meaning that the ACRS can be disbanded on'ly by an amendment to the Atomic Energy

Act. By contrast, the ACMUI and the Advisory Committee on Nuclear Waste (ACNW)

were both established by the Commission to serve at the pleasure of the Commission.

Regardless how any particular advisory committee was established, all provide the

same basic service and are equally valued and heard by the Commission.

Purpose of the ACMUI

The ACMUI's charter defines its purpose as providing advice on policy and technical

issues that arise in regulating the medical use of byproduct material for diagnosis and

therapy.' The 'purpose statement in the charter further explains that the ACMUI

provides this advice as reque ted by the Director, Division of Industrial and Medical.

Nuclear Safety (IMNS), Office of Nuclear Materials Safety and Safeguards. In addition,

the ACMUI provides consulting services to staff, as requested by the Director, IMNS.

Administratively, the ACMUI reports to the Director, IMNS.

1
INTERACTION BETWEEN THE

ACMUI AND THE NRC STAFF

Working Relationship Between the NRC and the ACMUI

As explained in the previous section, the ACMUI provides advice and consulting

services directly to the NRC staff. The need for the ACMUI to provide this advice to

staff necessitates a close working relationship. This means that staff and the ACMUI

must communicate effectively so that staff fully understands the ACMUI's opinions

regarding implications or consequences of proposed regulation.

Nature of the NRC and the ACMUI Interaction

The ACMUI is comprised of professionals from all over the country who have full-time

positions with their primary employers. Because the ACMUl's busy professionals

provide its services on a part-time basis, the ACMUI holds public meetings infrequently

relative to the other NRC advisory committees. Furthermore, when the ACMUI meets,

it often brings many regulatory issues to the attention of NRC staff. While the NRC

staff always attempts to address these issues in a timely manner, the relative

infrequency of the ACMUI's meetings, combined with the volume of issues, plus the

diverse locations of the ACMUI members, are factors that can sometimes make

maintaining adequate and accurate communication a challenge. Nonetheless, when

the NRC staff and the ACMUI make an effort to interact sufficiently, important issues

are kept at the forefront and the ACMUI's advice continues to help the NRC staff

maintain public safety, while favorably impacting the regulated medical community.

The ACMUI typically holds public meetings twice per year. However, the committee

meets more frequently when necessary.

The Designated Federal Official and the ACMUI Chairman

Two key persons help maintain effective ACMUI and NRC staff interaction: the ACMUI

Chairman and the NRC's Designated Federal Official (DFO).

The ACMUI Chairman has several general duties related to position as Chair. These

include presiding over ACMUI meetings and maintaining order and decorum;

summarizing committee consensus votes or position statements; determining the

composition of subcommittees; and adjourning ACMUI meetings. A complete

description of the ACMUI Chairman's duties may be reviewed in the ACMUI Bylaws.

2
The DFO is a Federal government employee charged with the proper general execution

of ACMUI meetings. No ACMUI meeting may be held unless the DFO is present, in

accordance with the General Service Administration's regulations in 41 CFR Part 102

and the NRC's regulations in 10 CFR Part 7.

The DFO performs several duties that support the functioning of the ACMUI. These

include convening and approving all ACMUI meetings; approving the agenda; attending

all meetings; adjourning meetings when doing so is in the public interest; ensuring

compliance with 10 CFR Part 7 in the generation of the minutes of ACMUI meetings;

and chairing ACMUI meetings when so directed by the Commission. The DFO may

also chair ACMUI meetings when the-Chair is recused or in the absence of the Chair.

The ACMUI Chairman and the DFO work closely together to accomplish two overall

objectives: (1) the effective use of ACMUI expertise to address and resolve emergent,

timely, and relevant issues that affect the public and the regulated medical community;

and (2) the officiation of ACMUI meetings in an open, orderly, publicly assessible

manner.

Open Session and Closed Session Public Meetings

Because the ACMUI is an advisory committee whose activities are regulated under 41

CFR Part 102 and 10 CFR Part 7, the ACMUI must conduct its activities in an open

forum that gives reasonable access to members of the public who may want to witness

the meeting's proceedings or speak at the meeting.

Although most ACMUI meetings are held in a public forum, some meetings cannot be

held publicly, because the ACMUI and NRC staff need to discuss certain sensitive

information, such as safeguards information, that can be protected from public

disclosure under the Government in the Sunshine Act. The regulations in 41 CFR and

10 CFR Part 7 allow the NRC staff to close meetings for such purposes.

Regardless of a meeting's status as open or closed, all meetings must be announced in

the Federal Register, in accordance with the regulations in 41 CFR and in 10 CFR Part

7. While open-session meetings are announced to afford the public opportunities to

view and/or speak at meetings, closed-session meetings are announced to inform the

public of these meetings' occurrence, and why it is necessary that such meetings be

closed.

ACMUI Compensation and Conduct

ACMUI members are compensated for their service to the Commission. This means

that, while conducting ACMUI business, ACMUI members are a special class of Federal

Government employees, working for the NRC. The NRC staff understands that the

ACMUI is composed of stakeholder licensees, and as such, will represent licensee

3
concerns to some extent. This is not only inevitable, but desirable. Nonetheless,

ACMUI members must remember that, as compensated Federal Government

employees, they are subject to the laws and regulations on conflict of interest. Under

those laws and regulations, they should not advise the NRC or participate in any

ACMUI matter when doing so will directly and predictably affect their financial interest or

the financial interest of members of their families; their employers; or anyone else with

whom they have a business relationship. ACMUI members also must not

inappropriately advance the views or positions of professional associations or the

regulated community.

Whenever a conflict-of-interest issue arises, the affected ACMUI member must recuse

himself or herself from voting on the particular activity that will cause the conflict of

interest.

4
...

INTERACTION- BETWEEN THE

ACMUI- AND THE.-COMMISSION

Purpose of Commission Briefings

The ACMUI interacts with the Commission primarily through formal, publicly announced

briefings. Briefings are scheduled adjacent to the Spring ACMUI public meetings,

whenever possible.

The ACMUI's briefing to the Commission typically consists of an update of major

initiatives for which the Committee has provided advice to staff. The briefing is also an

opportunity for the ACMUI to receive the Commission's feedback and/or positions on

initiatives that are.important to the ACMUI, the regulated medical community, and other

stakeholders.

The Commission has a strong interest in being kept abreast of new or evolving

technologies or issues that it should monitor, so that NRC staff can respond in a timely

and effective fashion to those issues, in its regulations or regulatory guidance.

Therefore, the ACMUI should always brief the Commission on such items.

Before each scheduled Commission briefing, the Commission requires the ACMUI to

forward, via the NRC staff, an agenda of the items to be discussed. The Commission

has final approving authority on agenda topics.

Briefing the Commission

It is desirable for the ACMUI to brief the Commission at least annually, but this is not

always possible. Conflicting schedules and competing priorities amongst the ACMUI

and the Commission can interfere with Commission availability, although such conflicts

are rare. The NRC staff is responsible for scheduling committee briefings to the

Commission.

Although the Commission appreciates any updates and insights the ACMUI may

disclose during briefings, ACMUI members should note that briefing the Commission

should not be viewed as a perfunctory exercise. Rather, it is desirable that the ACMUI

limit briefings to the Commission to instances when the committee has meaningful

information to share.

5
Outcome of ACMUI Commission Briefings

As stated previously, the ACMUl's briefing to the Commission is a good opportunity to

obtain Commission feedback and/or positions on initiatives that are important to the

ACMUI, the regulated medical community, and other stakeholders. During the course

of a briefing, the Commission may expound, to some extent, on the numerous and

divergent issues that the ACMUI raises, and may appear to come to conclusions

regarding those issues. After the briefing, however, the Commission will thoroughly

consider those issues, and its final decisions may be slightly different than what the

ACMUI anticipated. The ACMUI should be aware of this possibility, and keep in mind

that the Commission will commit to a certain course of action only after thorough,

thoughtful consideration of issues.

Based on its decision, the Commission will then direct staff, by use of a Staff

Requirements Memorandum (SRM), to take a certain course of action. The staff may

take action only in accordance with the mandates in the SRM, and may not take action

based on conversations between the Commission and the ACMUI during briefings.

6
STAFF HANDLING OF ACMUI

RECOMMENDATIONS

While conducting public meetings, the ACMUI often forms recommendations, which

become matters of public record. These recommendations usually require some sort of

formal staff action.

After ACMUI meetings, the staff reviews the ACMUl's recommendations and

determines whether they should be modified, disapproved, or adopted as stated.

Whether modified, disapproved or adopted, NRC staff will provide a basis for its

decision. The NRC staff will always carefully consider the ACMUl's recommendations,

but not all may be accepted. When there is strong ACMUI disagreement with the NRC

staff regarding a recommendation, the ACMUI should consider revising the

recommendation, for further NRC consideration and review.

It is helpful if the ACMUI keeps in mind that the NRC staff evaluates recommendations.

not only for their feasibility and sound regulatory value, but also to determine if they will

likely be met with strong objections from other stakeholders such as Congress or the

general public. If the NRC staff determines that any recommendation will likely be met

with strong public disapproval, the ACMUI should consider modifying that -

recommendation.

Whether the NRC staff accepts or rejects any ACMUI recommendation, the staff

forwards all recommendations to the Commission. The ACMUI should be aware that it

is not normal Commission practice to respond directly to the ACMUI (or any other

advisory committee) regarding a recommendation the committee made. Rather, the

Commission reviews the recommendation(s), makes regulatory decisions, and directs

staff to take further action through an SRM.

7
TYPES AND PURPOSES OF

ACMUI EVALUATIONS

The Commission requires two types of evaluations of the ACMUI:

1) Staff evaluations of the ACMUI, and;

2) ACMUI evaluations of itself.

The staff evaluates the ACMUI to give the Commission feedback on the performance of

the committee. Likewise, the purpose of ACMUI self-evaluations is for the committee to

inform the Commission as to how well it is fulfilling its purpose.

Evaluations are important for several reasons. First, they are a tool that helps the

Commission determine whether the committee is functioning as intended. Second,

they help identify any issues that may impede the committee's ability to serve the staff

effectively. Finally, they help the Commission justify the expenditure of NRC resources

to support committee activities.

Evaluations are due every 2 years, and the NRC staff will initiate them. It is important

that all committee members respond to the evaluation, so that the Commission receives

a complete depiction of the committee's efforts to fulfill its purpose.

8
....

References

Code of Federal Regulations, Title 10, Energy, Part 35, "Medical Use of Byproduct

Material."

Code of Federal Regulations, Title 41, Public Contracts and Property Management,

Part 102, "Federal Advisory Committee Management."

9
NRC roilm 335 U.S. NUCLEAR REGULATORY COMMISSION 1. REPORT NUMBER

12-89) (Assigwd by NRC. Add Vol.. Supp.. Rev..

NRCM 1102. BIBLIOGRAPHIC DATA SHEET end Addendum Numbers. It any.)

3201.3202 BBIGAHCDT HE

(Ste histnuctAb on tMe rovenr"

2. TITLE AND SUBTITLENUREG/BR-0309

Serving on the Advisory Committee on the Medical Uses of Isotopes (ACMUI): 3. DATE REPORT PUBLISHED

A Members Guide T 1

March 2004

4. FIN OR GRANT NUMBER

5. AUTHOR(S) 6. TYPE OF REPORT

Angela R. Williamson

7. PERIOD COVERED (indlush Dates)

8. PERFORMING ORGANIZATION -NAME AND ADDRESS (INRC prio*Dsbn. Oflce or Rgn. US. Ndr Ratoy COmm-bss nOd mal ddrs I wcontucor.

provie namo and maft address.)

Division of Industrial and Medical Nuclear Safety

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Washington. DC 20555

9. SPONSORING ORGANIZATION.-NAME AND ADDRESS (if NRC. Isaamas boveico)ractor.prvv NRCDMsAn Offloe or Ragbn. U.S. Nud&rRtubAoryComnmusbn

andmRAV Adns.)

Same as above.

10. SUPPLEMENTARY NOTES

11. ABSTRACT (200 wrds oress)

The Advisory Committee on the Medical Uses of Isotopes (ACMUI) provides a valuable service to the staff of the Nuclear

Regulatory Commission (NRC) through the advice and recommendations It gives staff.

To be able to advise staff effectively, it is important that the ACMUI have a basic understanding of its role and its

responsibilities. Ukewise, it is also important that the committee have a basic understanding of NRC processes and

requirements. Such understanding creates an environment where the ACMUI can effectively advise the NRC staff. Effective

advice, in tum, serves patients, the public, and the medical regulated community by helping the NRC staff develop regulations

that promote safety and are useful, realistic, practical, and not overly burdensome on NRC medical licensees.

12. KEY WORDSIDESCRIPTORS (List words orphrases that wssist rosearchersk locatIg the report) 13. AVAILAMILITY STATEMENT

ACMUI unlimited

Medical 14. SECURllY CLASSIFICATION

Designated Federal Official (This Page)

unclassified

(This Report)

unclassified

15. NUMBER OF PAGES

16. PRICE

NRIC FORM 335 (2-89) This form was electronically produced by Elite Federal Forms. kc.
L Printed

on recycled

paper

Federal Recycling Program
NUREGIBR-0309 SERVING ON TIlE ADVISORY COMMITTEE ON THE

MEDICAL USES OF ISOTOPES (ACMUI): A MEMBER'S GUIDE

MARCH 2004

UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

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