ML20211A820

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USNRC NMSS ACMUI Bylaws
ML20211A820
Person / Time
Issue date: 01/05/1995
From:
NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI)
To:
Shared Package
ML20211A766 List:
References
NACMUI, NUDOCS 9709240400
Download: ML20211A820 (9)
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January 5, 1995 i

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1 j U.S. tidCLEAR REGULATORY COMMISSION -

! 0FFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS  :

.i ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES

BYLAWS 1

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9709240400 970923 1

PDR ADVCM NACMUI PDR

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CONTENTS Page

1. Scheduling and Conduct of Heetings .......... 1 2.- Minutes . . . . . . . . . . . . . . . . . . . . . . . . 2
3. Appointment of Members . . . . ............ 3 1
4. Conduct of Members . . . . . . ............ 3
5. Amendments . . . . . . . . . . ............ 3 s

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Q PREAMBLE These Bylaws describe the procedures to be used by the Advisory Committee on Medical Uses of Isotopes (ACMUl), established pursuant to Section 161a of the Atomic Energy Act of 1954, as amended, in performing its duties, and the responsibilities of the members. For parliamentary matters not explicitly addressed in these Bylaws, Robert's Rules of Order will govern.

, These Bylaws have as their ourpose fulfillment of the Committee's responsibility to provide o)jective and independent advice to the Commission through the Office of Nuclear Material Safety and Safeguards, with respect to l the development of standards and criteria for regulating and licensing medical l uses si byproduct material. The procedures are intended to ensure that such

! advice is fairly and adequately obtained and considered, that the members and l the affected parties have an adequate chance to be heard, and that the l resulting reports represent, to the extent possible, the best of which the l Committee is capable. Any ambiguities in the following should be resolved in such a way as to support those objectives.

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BYLAW 3 - ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 1, Schedulina and Conduct of Meetinas The scheduling and conduct of ACMUI meetings'shall be in accordance with the requirements of the Federal Advisory Committee Act (FACA), as amended, 10 CFR Part 7, and other implementing instructions and regulations as appropriate.

1.1 Schedulina of Meetinas:

1.1.1 Meetings must be approved or called by the De'signated Federal Officer. At least two regular meetings of the Committee will be scheduled each year. A spring meeting will be scheduled in April-May, and a fall meeting will be scheduled in October-November.

Additionally, the Committee will meet with the Commission each year in the first or second quarter of each year.

1.1.2 Special meetings will be arranged as the need arises.

1.1.3 ACHUI meetings will be open to the public, except for those meetings or portions of meetings in which matters are discussed that are exempt from public disclosure under FACA or other appropriate rules or statutes.

O 1.1.4 All meetings of the Committee will be transcribed. During those portions of the meeting that are open to the public, electronic recording of the proceedings by members of the public will be permitted. Television recording of the meeting will be permitted, to the extent that it does not interfere with Committee business, or with the rights of the attending public.

1.2 Meetina Aaenda:

The agenda for regularly scheduled ACMUI meetings will be prepared by the Chair of the Committee (referred to below as "the Chair") in consultation with the Nuclear Materials Safety and Safeguards (NMSS) staff. The Designated Federal Officer must approve the agenda. The Chair will query committee members for agenda items prior to agenda preparation. A draft agenda will be provided to committee members not later that thirty days before a scheduled meeting. The final agenda will be provided-to members not later than seven days before a scheduled meeting.

Before the meeting, the Chair and the Designated Federal Officer for the Committee will review the findings of the Office of the General

- Counsel regarding possible conflicts of-interest of members in-relation to agenda items. Members will be recused from discussion of those agenda items with respect to which they have a conflict.

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Bylaws - Advisory Committee on the Medical Uses of Isotopes 1.3 Conduct of the Meetina:

1.3.1 All meetings will be held in full compliance with the Federal Advisory Committee Act. Questions concerning compliance will be directed to the NRC Office of the General Counsel.

').3.2 The Chair will preside over the meeting. The Designated Federal Officer will preside if the Chair is absent, if the Chair is recused

' *a participating from discussion of a particular agenda item, or if u rected to do so by the Commission.

1.3.3 A majority of the current membership of the Committee will be required to constitute a quorum for the conduct of business at a Committee meeting.

1.3.4 The Chair has both the authority and the responsibility to maintain order and decorum, and may, at his or her option, recess the meeting if these are threatened. The Designated Federal Officer will adjourn a meeting when adjournment is in the public interest.

The Chair may take part in the discussion of any subject before the Committee, and may vote. The Chair should not use the power of the O 1.3.5 Chair to bias the discussion. Any dispute over the Chair's level of advocacy shall be resolved by a vote on the Chair's continued participation in the discussion of the subject. The decision shall be by a majority vote of those members present and voting, with a tie permitting continued participation of the Chair in the discussion.

1.3.6 When a consensus appears to have developed on a matter under consideration, the Chair will summarize the results- for the record.

Any members who disagree with the consensus shall be asked to state their dissenting views for the record. Any committee memoer may request that any consensus statement be put before the ACMV1 as a farmal motion subject to affirmation by a formal vote. No Committee position will be final until it has been formally adopted by consensus or formal vote, and the minutes written and certified.

2. MINUTES 2.1 The. Chair will prepare detailed minutes of each ACMUI meeting (excepting meetings with the Commission for which transcripts are prepared) based on the transcripts of the meeting.

2.2 A draft of the minutes will be prepared by the Chair, assisted by the NRC staff, and made available as soon as practicable to the other members. After receiving corrections to the draft minutes from the 2

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Bylaws - Advisory Committee on the Medical Uses of Isotopes Committee members, the Chair will certify the minutes. By certifying the minutes, the Chair attests to the best of his or her knowledge to the completeness and technical accuracy of the minutes.

2.3 Copies of the certified minutes will be distributed to the ACMul

< members. The staff will then forward the minutes to the Public Document l Room, with only deletions authorized or required by law.

3. APPOINTHENT OF MEMBERS 3.1 The members of the Committee are appointed by the Commission, which determines the size of the Committee. The NRC will solicit nominations by. notice in the Federal Register and by such other means as are approved by the Commission. Evaluation of candidates shall be by such procedures as are approved by the Commission. The Commission has the final authority for selection. The term of an appointment to the Committee is-two years, and the Commission has determined that no member may serve more than three consecutive terms.

3.2 The Chair will be appointed by the Commission. The Chair will serve for

-a period of two years, and will be eligible for reappointment by the O

Commission for two additional two-year terms.

4. CONDUCT OF MEMBERS 4.1 If a member feels that he or she may have a conflict of interest with regard to an agenda item to be addressed by the Committee, he or she should divulge it to the Chair and the Designated Federal Officer as soon as possible, but in any case before the Committee discusses it as an agenda item. Committee members must recuse themselves from discussion of any agenda item with respect to which they have a conflict of interest.

4.2 Upon completing their tenure on the Committee, members will return any privileged documents and accountable equipment (as so designated by the NRC) provided for their use in connection with ACMUI activities, unless directed to dispose of these documents or equipment.

4.3 Members of the ACMUI are expected to conform to all applicable NRC rules and regulations.

5. ADOPTION AND AMENDMENTS 5.1 Adoption of these bylaws shall require a vote of two-thirds of the current ACMUI membership and the concurrence of the Director of the Office of Nuclear Material Safety and Safeguards.

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1 Bylaws - Advisory Committee on the Medical Uses of Isotopes 5.2 Any member of the Committee or NRC may propose an amendment to these Bylaws. The proposed amendm the Chairman and scheduled f.ent will at or discussion bethe distributed to the next regular members by Committee meeting.

5.3 The final proposed amendment may be voted on not earlier than the first regular meeting after it has been discussed at a Committee meeting pursuant to Paragraph 5.2.

5.4 A vote of two-thirds of the current ACHUI membership and the concurrence of the Director of the Office of Nuclear Material Safety and Safeguards shall be required to approve an amendment.

5.5 Any conflicts regarding interpretation of these Bylaws shall be decided by majority vote of the current membership of the Committee.

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DISCUSSION ITEMS FOR PREVIOUS RECOMMENDATIONS OF THE ACMUI 1 ACMUI recommended by a 9 to 1 vote that Statements 2 and 3 of 1979 Medical Policy 1 i Stjatement be revised to read as follows (note that the bold is the recommended additions and l the bracketed [] text removed): j Statement 2: The NRC will regulate the radiation safey of patients only were justified by the risk to the patients, and only where voluntary standards or compliance with thest standars are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.

Statement 3: The NRC will [ minimize intrusion) not intrude into medicaljudgements affecting patients and into other areas traditionally considered to be a part of the practice of medicine.

REMARKS: Cathy Hanev will be discussina the chances recommended by the ACMUI in her oresentation of the alternatives to the rule lanausgg,

2. ACMUI recommend retention of the current regulatory approach for [Part) 33. The vote was 9 to 1 to retain the current regulatory approach.

O REMARKS: The staff is currentiv develoolna a commission oaoer which contains the ACMul recommendations for Part 33.

3. ACMUl recommends the NRC modify the QM inspection procedures with the intent to reflect the spirit of the Commission direction in the SRM [regarding DSl 7). The vote was 9 for and 1 abstention.

BEMARKS: No actions has ben taken to date. This matter is under consideration.

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Cys: Callan Jordan 1 .( /# .u.No ',

UNITED STATa$ . Thompson Norry

.  ! t NUCll.AR REGULATORY COM' MISSION w Aswewatow. o.c. rosss Blaha

{ i IN RESPONSE, PLEASE g% , June 5. 1997 REFER TO: M970508 Paperiello, NMSS i

0" 'C ' " T " 8 Ross AEOD 4 SE C R E T A R Y i

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MEMORANDUM TO
Judith A. Stitt, Chairman

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Advisory Committee on Medical Uses of Isotopes i Karen D. Cyr Gene 1 un e FROM: Joh ~. Hoy , Secretary

SUBJECT:

STAFF REQUIREMENTS - MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPE" (ACMUI), 9:00 A.M., THURSDAY, MAY 8, 1997,

The Commission requested the ACMUI to take a focused look at i

revisions to Part 35, including test cases, as the Commission '

moves toward a more risk-informed, performance-based regulatory program. In providing recommendations, the Committee should j

i address the questions posed by the Commissioners during the 4 meeting, which include the following: (NMSS) 9700229

1. How should the NRC determine which industry standards, 3

1 including voluntary ones, are adequate to meet the NRC's regulatory responsibility for patient, worker, and public safety? To what extent shoold NRC allow th. ,i.censee flexibility in interpreting or selecting an industry

standard? How should the concept of " quality improvement" be incorporated into reliance on industry standards and an

! accreditation-type of approach to licensing and inspection?

2. What are the necessary transition steps the NRC should take in order to implement a more positive enforcement program that, in effect, encourages or rewards good perfernance while addressing the. outlyers. What metrics should the NkC use to decide whether the approach is working?
3. In considering various events (e.g., misadministrations, equipment fai)ures, or procedural errors), what criteria 4 should the NRC use to determine that a particular event is Q'] 00 Gf 00 $

2-isolated, rather than having program implications for that licensee or generic implications for other medical licensees? What is the best process for the reporting of

,i events to ensure that the NRC is aware of potential generic j issues?

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! 4. in evaluating erroro, should a threshold be established j benee*,h which corrdetive action is not required? How would ,

such e thresbeld be set, and how would it be implemented?

i The Commission requested OGC to provide an ant;/ sis of whether  !

i the Atomic Energy Act supports ACMUI's proposal that NRC l

{ regulation shodld tolerate a level of risk in radiation medicine j comparable to the level of risk associated with other practices of medicine. .

(00C) (SECY Suspense 8/22/97) 1 J

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cc: Chairman Jackson i Commissioner Rogers I

Commissioner Dieus Commissioner Diaz j Commissioner McSaffigan i EDO i

CFO CIO

) OCI.

! OIG

! Office-Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) j PDR - Advance

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