ML20211A984

Forwards Summary Minutes of Meeting of ACMUI Held on 970410-11.Summary of Major Items Discussed in Minutes Encl

ML20211A984
Person / Time
Issue date:	05/01/1997
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Diaz N, Dicus G, Shirley Ann Jackson, Mcgaffigan E, Rogers K, The Chairman NRC COMMISSION (OCM)
Shared Package
ML20211A766	List: ML20211A761 ML20211A800 ML20211A820 ML20211A880 ML20211A887 ML20211A984 ML20211B038
References
NACMUI, NUDOCS 9709250034
Download: ML20211A984 (6)

Text

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1 p Ktt Ob 4 UNITED STATES

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( ., j NUCLEAR REGULATORY COMMISSION  !

. WASHINGTON, D.C. 20565-0001 f

• • • • • May 1, 1997 MEMORANDUM T0: Chairman Jackson 4 Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffig n FROM: L. Joseph Calla Executive Director r Operations

SUMMARY

MINUTES OF THE MEETING 0F THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES HELD ON APRIL 10 AND 11. 1997 Attached are the summary minutes of the meeting of the Advisory Comittee on the Medical Uses of Isotopes (ACMUI) held on April 10 and 11, 1997. Also attached is a sumary of the major items discussed in the minutes (Attachment p 1). This information serves to address the Comission's interest in the U ACMUI's preliminary views regarding Direction Setting Initiative 7 and the Staff Requirements Memorandum - COMSECY-96-057, in preparation for the ACMUI May o.1997. Comission Briefing.

Attachments: 1. Summary of Major Issues

2. ACMUI Minutes, dtd 4/22/97 cc: SECY OGC OPA OCA I William B McCarthy. NMSS/IMNS CONTACT:

1 301) 415-7894 b)

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Attachment 1

SUMMARY

OF MAJOR ISSUES There were three votes during the day and a half meeting, the ACMUI recommendations are as follows:

The ACMUI recommended by a 9 to 1 vote that Statements 2 and 3 of 1979 Medical Policy Statement be revised to read as follows (note that the bold is the recommendedadditionsandthebracketed{}textremoved):

. Statement 2: The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards 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: TheNRCwill{minimizeintrusion}notintrudeintomedical judgements affecting patients and into other areas traditionally considered be a part of the practice of medicine.

The dissenting vote was cast by Ms. Brown. She indicated that the current Medical Policy Statement is adequate and that no changes were needed The ACMUI brought the following motion to the table: "ACHUI recommends retention of the current regulatory approach for [Part] 33." The vote was 9 for and 1 opposed. Dr. Williamson stated in opposition that "[he does not]

feel able to assess the rigidity and flexibility of the current process relative to what might happen at this time."

The ACHUI brought the following motion regarding the Quality Management inspection procedures to the table: "[the ACMUI recommends that the NRC) modify the OM inspection procedures with the intent to reflect the spirit of the Commission direction in the SRM [regarding DSI 7)." The vote was 9 for the motion and 1 abstention. Judith Brown abstained because she was not familiar with all of the elements of the issue. Dr. Wagner wished to go on the record stating that the QM rule as a regulation was unnecessary.

In addition to the three formal votes by the Committee, they also discussed at great length the definition of risk, and were not able to reach closure in a definition and how to apply risk over-all.

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l Discussion of Evaluation of Committee and Committee Membership i

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! Speaking points will be provided at a later date.

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UNITED ST ATEs NUCLEAR REGULATORY COMMISSION Cys: Taylor

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,I Thompson U \ / August 21. 1986 Blaha OFFICE OF THE

' SECRETARY MEMCRANDUM TO: James L. h11hoan Co-chairperson, Strategic Assessment and Rebaselining Steering Committee James W. Johnson Co-chairperson, Strategic Assessment and Rebaselining Steering Committee i

! James M. Taylor Executive Director for Operations l John T. Larkirr e utive Direstor/ACRS/ACNW b

FROM: ohn . oyle, Secretary 1 -

SUBJECT:

STAFF REQUIREMENTS - COMSECY-96-028 STRATEGIC ASSESSMENT ISSUE PAPER:

' INDEPENDENT OVERSIGHT (DSI 19) i O

^\) \ The Commission does not believe that this issue is direction i

setting and believes that it should not be included in the set of i issue papers for public comment. In addition to the Strategic Assessment and Rebaselining Steering Committee, the Advisory Committee on Reactor Safeguards, Advisory Committee on Nuclear Waste, and the EDO are requested to respond to the actions described below. Furthermore, this issue paper should be given The issue paper j normal distribution asscciated with SECY papers.

does not require revision prior to release.

The Commission continuel to believe that independent technical oversight is essential in order to ensure that NRC's products are of ther highest technical quality and the Commission's decisions have the public's confidence. But considering the changing environment, the reduction of workloads in a number of areas under the purview of several of the referenced independent oversight- committees , the duplication of the activities between committees in some areas, and the cost in funds and FTE's associated with all the agency's committees, the Commission's decision on this DSI is modified versions of options 2 (Continue Current Independent Technical Oversight; Conduct Comprehensive, Feriodic Review of Committee Charters) and 1 (Establish Criteria to Articulate the Threshold for the Need and Type of Independent A Technical Oversight) as summarized below:

1. (Modified Option 2) The ACRS should remain as the

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Tad Commission's primary independent technical oversight committee. The Commission believes that the committee's charter should be given a comprehensive review to evaluate what adjustments in the scope and depth of the committee's charter are needed in light of the changing external and internal factors discussed in the DSI paper.

Even though the ACNW is experiencing a decrease in its activities and there are also many uncertainties about the agency's future activities associated with HLW and LLW ,

l programs, the Commission continues to believe that issues presently being addressed by the ACNW will centinue to exist in one form or another; therefore, the commission believes that some form of independent technical oversight should be retained for the areas under the purview of the ACNW. The Commission requests that ACNW retain its current form in the interim but the staff should examine the pros and cons of having ACNW remain in its current form or as a stand alone subcommittee of ACRS. Either option would allow the Commission to retain independent technical oversight of both areas, i.e., reactors and waste. This aleo preserves the option of having an active body of expertise available should the activities under the purview of both the ACRS and r~'s the ACNW increase in the future.

(ACRS/ACNW) (SECY Suspense: 1/2/97)

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2. The Commission believes that the role of the ACMUI should be re-examined and addressed after the determination is made on the NRC's role in the materials / medical program area.

(GDG/ACMUI) (SECY Suspense: 180 days after final WGS Com.nission decision on medical program) 9600117

3. (Modified Option 1) The Commission believes that the activities of the NSRRC should be revisited. This committee played an important role in its first few years of existence in ensuring the effectiveness of the research program in addressing the evolving regulatory needs.

(BDG/NSRRC) (SECY Suspense: 9/30/96) 9600118 RES

4. The Commission believes that CRGR should be retained but its scope should be revisited. While the Commission continues to believe the scope should be expanded to include NMSS activity, it also believes consideration should be given to including reactor inspection guidance within the scope of CRGR.

(B}3/CRGR) (SECY Suspense: 11/29/96) 4 9600119 AEiOD In general, for the independent oversight committees that remain, as well as the CRGR, the Commission supports Option 2 but f

,-s\ believes that the periodic reviews should not be limited to only

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the committee charters. Each committee should be evaluated to determine what value it is contributing to achieving the agency's i

'*b . 3-mission,'but the committee should also be directly involved in this evaluation. That is, each committee is requested to produce a set of criteria, for Commission consideration, under which the performance of the committee would be evaluated in the future.

I Each committee should then periodically review itself against these criteria and provide the results of this evaluation to the l

Commission.

(ACRS/ACNW) (SECY Suspense: 1/2/97) 6/30/97) 4

! 9600120 RES (EDO/NSRRC) (SECY Suspense:

- 9600121 AEOD (EBO/CRGR) (SECY Suspense: 11/29/96)

' (SECY Suspense: One year,after 9600122 letSS (BBO/ACMUI) final decision on medical program) 4 1

4 i cc: Chairman Jackson i Commissioner Rogers i Commissioner Dicus j .

K. Cyr (OGC)

, D. Rathbun (OCA)

! H. Bell (OIG) 1 O -Y I

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RULEMAKING ISSUE (Information)

June 20, 1997 SECY-97-131 FC R: The Commissioners FROM: L. Joseph Callan

, Executive Director for Operations

SUBJECT:

SUPPLEMENTAL INFORMATION ON SECY-97-115, " PROGRAM FOR REVISION OF 10 CFR PART 35, ' MEDICAL USES OF BYPRODUCT MATERIAL,' AND ASSOCIATED FEDERAL REGISTER NOTICE" PURPOSE:

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To provide the Commission with supplementalinfom ation and an attemative program for the revision of 10 CFR Part 35.

CATEGORY:

This paper addresses significant rulemaking issues requiring Commission consideration and approval.

BACKGROUND:

On June 5,1997, in SECY-97-115, the staff requested Commission approval of: (1) its proposeo program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Pelicy Statement, if necessary; and (2) a Federal Reaister notice (FRN) of proposed rulemaking, for publication, to solicit public comments about restructuring Part 35 into a risk-informed, more performance-based regulation.

CONTACTS $ Diane S. Flack, IMNS/NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE (301) 415-5681 IN 5 WORKING DAYS FROM THE DATE OF THIS PAPER Susanne Woods, IMNS/NMSS (301) 415 7267 i

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The Commissioners 2 On June 13,1997, the staff briefed the Commission on its proposed program for revising Part 35 as described in SECY-97-115. In addition, the staff and the Commission discussed an altemative approach to revising the regulation. The Commission requested that the staff supplement SECY-97-115 with a desenption of the attemative approach, as well as with the estimated resources.to complete the rulemaking, if this altsmative were implemented.

DISCUSSION:

Attachment 1 describes the staff's attemative approach for revising Part 35 and the associated guidance documents. Under the attemative, the staff would immediately begin preparing proposed rule language and attematives using a " modality" approach (Attachment 2). The attemative differs from the program recommended in SECY-97-115 in several respects. First, there would be no formal public opportunity for comment at the beginning of the process. The staff would consider comments and rule language attematives beginning immediately, but the first more formal opportunity for public interactions would be during facilitated public meetings in the fall of 1997. The staff would, under the attemative, provide a proposed rule; associated documents such as the regulatory analysis, environmental assessment, and finding of no significant environmental impact; and the Office of Management and Budget clearance package to the Commission in May 1998' At that same time, the staff would expect to provide the Commission witt draft guidance documents for each of the proposed rule modalities, and its recommendations regarding the need for any

[ changes to the 1979 Medical Policy Statement. Following Commission approval, the

( ]/ proposed rule and draft documents would be published for public comment. The legal minimum time for public comment on a proposed rulemaking is 75 days. The staff would expect to provide a final rule, associated documents, and final guidance documents for Commission approval in May 1999.

Under the attemative, there would be more public interactions than the usual rulemaking and comment process of the Administrative Procedure Act, in the following respects. First, public input would begin immediately and continue throughout the development of the rule attematives and facilited public meetings in the fall of 1997. Consideration of comments would be cut off at a point aporoximately two-three months before providing the material to the Commission for approval. Rulemaking attematives and drafts would be made publicly available on an ongoing basis, including posting them on an INTERNET page, and the staff would make available the comments received, both in the PDR, and to the extent possible, electronically in the INTERNET. If the altemative revision program described in this supplemental information is approved, staff would revise the Federal Reaister notice in SECY-97-1.1 5 to notify the public of the approved program and the availability of documents on the INTERNET. The staff would continue, as proposed in the original program outlined in SECY-97-115, to solicit comments and specific rule text proposals from various professional societies. The staff would also continue its proposci to use both consultants, and a working group and steering group approach to the development of the documents. The staff would particularly look into obtaining consultants or other information sources that can provide an indication of the current trends in medical practice, in addition to vigorously using the m

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'As the staff proceeds with this rulemaking, the staff will be alert to issues or areas where more immediate rulemaking is appropriate.

The Commissioners 3-Advisory Committee on the Medical Uses of Isotopes.

RESOURCES:

2 Resource projection,s associated with revising Part 35 and associated documents for fiscal s years (FY) 1998, FY 1999, and FY 2000 were provided to the Commission in SECY-97-115.

Staff does not anticipate any change in the resources needed, in FY 1998 and FY 1999, to complete the rulemaking effort by May 1999. The primary resource needs are based upon development of the rule, associated documents, and corresponding guidance. Since this task is unchanged, the resource estimates are unchanged. Since the rulemaking effort would be completed in FY 1999, the resources identified in SECY-97-115 for FY 2000 would be used -

in other areas of the medical program.

't RECOMMENDATION:

i That the Commission approve the Part 35 revision program described in the attachment to

• his document.

COORDINATION:

1 The Office of the General Counsel reviewed this paper and has no legal objection. The Chief Financial Officer and Chief Information Officer have no objection to this paper.

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i . seph Callan Ex cutive Director for Operations Attachments:

1. Altemative Program for Medical Revision

2. Modality Outline for 10 CFR Part 35 DISTRIBUTION:

Commissioners OGC OCAA -

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( ALTERNATIVE PROGRAM FOR MEDICAL REVISION

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The following is an attemative program for the revision of 10 CFR Part 35, as discussed with the Commission on June 13,1997.

The attemative consists of the following program elements.

1. The staff would immediately initiate development of draft language and rule altematives, and make these materials publicly available on an ongoing basis, including posting them on an INTERNET page, and would consider comments, suggestions, and other attematives that result from these interactions. Public input would begin immediately and continue throughout the development of rule attematives, facilitated public meetings in the fall of 1997, and development of the proposed rule. The staff would interact with professional societies and the public to solicit, on an informal basis, comments and rule text. In addition, staff would prepare a Federal Reoister notice to notify the public of the approved Part 35 program and the availability of documents on the INTERNET.

2. Per Management Directive 6.3, the staff proposes to conduct this rulemaking using a group approach. Development of rule text attematives, including draft guidance documents, would use a working group (or groups) and steeri1g group approach. The staff proposes to enhance the State participation in the proces.s through the indusion of State individuals in both the working group and the steering group. This participation would facilitate the Conference of Radiation Control Program Directors'

(,,/ (CRCPD's) development of corresponding rules in its suggested State regulations, and would allow the State staff to focus on potentialimpacts of Wuclear Regulatory Commission draft language on the regubtion of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research in the States.

3. Facilitated public round table meetings in the fall of 1997 would be used to focus discussion on specific rule text and attematives. Discussions would also be held in meetings with the Advisory Committee on the Medical Uses of Isotopes (ACMUI), and wi'h the Organization of Agreement States. The exact timing of the meetings would depend on the process to convene and facilitate these meetings, but it is expected that the meetings could be conducted in the late September to November 19??

timeframe.

4. Based on the informal and formal public interactions, the staff, using the working group and steering group approach, would develop the proposed rule and associated documents including the regulatory analysis, environmental assessment, finding of no significant environmental impact, and Office of Management and Budget clearance for Commission review and approval. The staff would also develop draft guidance documents for each medical modality of the proposed rule, for publication as drafts for comment, in parallel with the proposed rule, and would provide for Commission consideration, any iccommendations regarding changes to the 1979 Medical Policy Statement. During the development process, the staff would continue to make drafts publicly available, but would need to cut off consideration of comments at a point i approximately two-three months before providing the material to the Commission for

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approval. Comments received after that time would be considered as part of the ATTACHMENT 1

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2 L ongoing interaction process; and as part of the comments received during the formal

public comment period on the proposed rule after Commission approval.

!. - 5. Following Commission approval, the proposed rule and draft documents would be.

! published fot publi: comment. The legal minimum time for public comment on a ,

j proposed rulemaking is 75 days. The staff would make the drafts available on the

INTERNET, and would accept comments electronically. The staff would also hold two

. public meetings, during the formal comment period, to facilitate comments.

1

6. Development of the final rule, associated documents, and final guidance would be .

through the working group and steering group. The staff would continue to make draft documents available, but would not be able to consider further extemal input beginning approximately four months before the submission of the final dc,cuments for .

Commission approval. The staff would discuss the final documents with the ACMUI, and with the Agreement States, prior to submission to the Commission. The staff would expect to provide the final documents for Commission approval in May 1999.

ATTACHMENT 1

< ' MODALITY OUTLINE FOR 10 CFR PART 35 In developing the revisions to 10 CFR Part 35, the staff proposes to move the rule to an entirely modality based approach, as discussed with the Commission on June 13,1997. This approach is described briefly below.

Part 35 is currently p mixture of modality specific requirements, and generally applicable requirements. The staff proposes to reexamine the current divisions, and, based on risk, develop a set of requirernents that are specific to each modality. At this time, the staff anticipates that the following modalities would be addressed:

1, low-dose unsealed materials (diagnostic nuclear medicine);

2. high dose unsealed materials (nuclear medicine therapy);

3. Iow-dose sealed source applications; 4, teletherapy;.

5. high-dose-rate . emote afterloaders;

6. gamma stereotactic surgery; and 7, emerging technologies.

The above list is not viewed as all-inclusive. Additional categories may be developed, depending on the breadth of the areas to be covered, and the similarity of requirements in a given area.

The modality approach envisioned would place all requirements for a given type of treatment O' into a single section of the regulation, including who or what organization is licensed; what type of license is issued; the necessary technical requirements, such as surveys and calibration; the training and experience requirements; the event recording and reporting requirements; and the quality improvement and management objectives Thus, requirements ,

I can be tailored more specifically for each modality (as listed above), with those posing lower risks having fewer or simpler requirements, and those posing higher risks having correspondingly more stringent requirements.

The advantage of organizing Part 35 to be entirely modality driven is that the rule can be modified to incorporate new modalities by simply adding a new subpart to address the-sctivityc The staff envisions tnat new approaches would initially be licensed under the emerging technologies modality, where the rule requirements would be general in nature, and the specifics would be contained in license conditions. As experience was gained in the regulation of that modality, a rulemaking to add a new subpart to address the specific modality could then be undertaken, and there would be no neM to revise the regulations for the other modalities.

The downside of the modality approach is that there would need to be some repetition between the subparts, since some of the requirements would be similar for at least some of the modalities. However, the staff believes at this time that this type of organization would -

make for a more flexible and usable regulation.

I ATTACHMENT 2

l k 2 RJ The following is a set of questions that have been developed for determining the contents of each modality section. This list is not intended to be all-inclusive.

1. . Who and/or what (e.g., facility) should be licensed?

2. What type of license (e.g., is registration a possibility)?

3. What terms should be defined?

4. Should there be an operational definition of " adequate protection,'such as performance criteria or a " safety goal *?

5. What are the " technical issues' that should be addressed (e.g., surveys, calibration, access controls, etc.)?

6- What training and experience (T&E) is necessary for what types of personnel involved in the modality?

a. Should T&E include not only physicians and radiation safety officers, but associated professional personnel (e.g., medical physicists)?

b. Should the focus of T&E be rariiation safety or extend to medical or other credentials? Is it sufficient to simply require the requisite licensure and credentials required by the State, for the medical specialty being practiced?

c. Are there needs to maintain qualifications and undertake periodic requalifications?

O 7. What duties and responsibilities should be set forth, and for which personnel?

8. What reports of " safety significant" medical events or " precursor" events should be required?

9. What should be the necessary Quality Management objectives that are essential for patient safety? Are there any additional specifications needed in addition to the basic objectives?

10. What records should be kept?

11. What provisions re;ative 'o enforcement should there be?

12. What provisions for amendments, renewals, exemptions, etc., should be included in the rule?

13. What, if any, provisions are needed for the protection of human research subjects?

14. Are there industry guides and standards available that either the regulation or guidance can rely on?

15. What interactions are there with other regulations, particularly 10 CFR Parts 20,30, 32, and 337 o

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ATTACHMENT 2 i

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ALTERNATIVE PROGRAM FOR REVISING 10 CFR PART 35, '

ASSOCIATED GUIDANCE DOCUMENTS , AND THE 1979 MEDICAL POUCY STATEMENT i

2Q97 3Q97 4Q97 1Q98 2Q98 3Q98 4Q98 1Q99 2Q99 Task Name May l Jun Jul l Aug l Sep Oct l Nov l Dec Jan l Feb l Mar Apr l May l .surt Jul l Aug l Sep Oct l Nov l Dec Jan l Feb l Mar Apr l May [

y Staff De.e:ep..e.-4 of Proposed Rule and Draft Guidance Dm ..m a, P R M. Y !- f Informal Pubtle Interactions  !

y 3 y informal Public Interactions

! Facilitated Public Meetings 7 ,

Commission Review / Approval  !

Draft Rule Commission Review' Approval Draft Rule i Public Comment-Proposed [

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Public Comment-Proposed Rule [

Staff Development of Final . ,

Rule and Guidance __.

Staff Developmen' of Final Rule and Guidance Dm .m.4. y y I Submit to Commission for l Approval. Submd to Commisskm for Approvat 5  !

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! Jordan Norry

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"'""'"' Shelton, C10 Meyer, ADM CHaney, NMSS SWoods NMSS MEMORAllDUM TO: L. Joseph Callan Execu 'v ^Di.fe tor for Operations

-k FROM: John '

. Hoy e,/ Secretary

SUBJECT:

STAFF RFQUIREMENTS - SECY-97-115 - PD.OGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED EEDFRtL t FIGISTER NOTICE The Commission has approved the staff proposal to revise 10 CFR Part 35 consistent with the alternative program proposed in SECY-97-131 and subject to the following comments.

(dp) 1. The staff should not only consider what regulations will be

' affected by the change to Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent the staff with the identify should Comtrission's direction in DSI 7, in the public meetings and Federal Recister notices all regulatory actions and proposed actions relating to or affecting Part 35 licensed activities. When appropriate, public comment should be invited.

2. The staff shou 3d continue to solicit input from members of the p wlic to ensure, to the The degree possible, that all staff should include groups interests are represented.

representing radiopharmacists and medical technologists, and other experts, as appropriate.

3. The staff should prepare alternatives with specific rule text to help focus the discussion during the first-round of i facilitated meetings and assist the staff in developing draft rule language for publication and comment.

(p) SECY NOTE: SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, V - 1997. THIS SRM, SECY-97-131, AND THE COMMIOSION l

VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL

' COMMISSTONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

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4. The staff should look fer potential resource savings (FTE, consultants, and funds) that can be achieved through use of the internet, teleconferencing, etc. In making documents available over the internet, some caution should be exercised to ensure that the number of and versions of available documents for comment are not so large and varied that they will overwhelm commenters and lead to confusion on the part of the staff and management responsible for the rule. making .

A Federal Recister notice and press release should be issued reflecting the approach outlined in SECY-97-131, attachments 1 and 2, and published in time to support the facilitated public meetings.

+s994- (NMSS) (SECY Suspense: 4/5/S2) 9700065 8/29/97 cc: Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Dia:

Commissioner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACIM, ASLBP (via E-Mail)

PDR DCS O .

Action: Paperiello/NMSS Morrison, RES t.

Cys: Callan

/o =.% UNITED STATES j'

k ... Thompson NUCLE AR REGULATORY COMMISSION Jordan j q wasmow.o c. mnooo'

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• March 20, 1997 Bangart, SP Ross, AEOD SECRffARY 1

MEMORANDUM TO: L. Joseph Callan

Exe ut ve D rector for Operations FROM

Jo C.

L oy_e, Secretary j ,

SUBJECT:

S AFF REQUIREMENTS - COMSECY-96-057

MATERIALS / MEDICAL OVERSIGHT (DSI 7) i With respect to the overall materials program, the commission- '

continues to support its preliminary views on this issue which were a combination of two options -- Continue the ongoing Program with Improvements (Option 2) and Decrease Oversight of Low-Risk 9 Activities with Continued Emphasis in High-Risk Activities i (Option 3). For the longer term, the Commission also believes i f that consideration should be given to broadening NRC's regulatory d -

oversight to include one or more of the higher-risk activities identified in Option 1. -

, With respect to the medical program, the Commission was not

persuaded by the National Academy of Sciences, Institute of .

. Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizino radiation in medicine. The Commission continues to believe that the conclusions in the. report were not substantiated and that the recommendations should not be pursued.

The Commission continue, to support the use of ACMUI and professional medical organizations and societies in developing

~

regulatory guides and standards as was proposed in the Commission's preliminary views. In the longer term, the Commission would be wil31ng to consider taking on broader regulatory i

other sourc, es responsibilities of ionizing radiation for higher but such risk activities efforts should involving not divert resources from the 10 CFR Part 35 rulemaking discussed below.

In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary. The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the i

program the staff ehould consider the following:

5OuW S?0

l- '

{.' -

J

- 2-Focusing Part 35 on those procedures that pose the

! (1)

highest risk.

i I

(2) For diagnostic procedures, staff should consider j regulatory oversight alternatives consistent with the i lower overall risk of these procedures. [

i L I (3) The staff should address how best to capture not only ,

s relevant safety-significant events, but also precursor j events.

a (4) Changing the nomenclature from " misadministration" to  :

" medical event" or comparable terminology.

l (5) Part 35 should be redesigned so that it can incorporate >

necessary regulatory requirements for new treatment i modalities in a timely manner. i (6) The Quality Management Program provisions (10 CFR Part  !

35.32) should be re-evaluated and revised to focus on

tl.sse requirements that are essential for patient j safety, e.g., confirming patient identity, requiring

written prescriptions and verifying dose. To the i

maximum extent possible, the requirements should be revised to be risk-informed. Given this objective, a  :

mixed approach of performance-based rules and otherwise  !

prescriptive regulations should be pursued.

(7) The staff should consider the viability of using or L referencing available industry guidance and standards 1 within Part 35 and related guidance to the extent that they meet NRC needs.

i (8) The staff should consider a rulemaking process tnat l provides more apportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking process but would be less

consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination.

l The staff's program to implement the above should be submitted to i the Commission for its consideration no later than June 6, 1997.

The program should target June 30, 1999 as the date for completing the rulemaking process. This rulemaking and associated guidance development is a very high priority for the Commission. The Commission is prepared to provide additional resources to the extent necessary to complete the rulemaking

<( process on this schedule.

l (NMSS/RES) (EDO - Program) (SECY Suspense: 6/6/97) 9700065 j (NMSS/RES) (EDO - Complete Rulemaking) (SECY Suspense; 6/30/99) 9700065 i

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• ,-~+-r-m.n--,e-+..- , , - ry--

l cc: Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner McGaffigan Commissioner Diaz K. Cyr D. Rathbun H. Bell A. Galante R. Scroggins W. Beecher O

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RULEMAKING ISSUE (Notation Vote)

June 5. 1997 S_ECY-97-115 FOR: .The Commissioners FROM: L. Joseph Callan Executive Director for Operations

SUBJECT:

PROGRAM FOR REVISION OF 10 CFR PART 35, MEDICAL USES OF BYPRODUCT MATERIAL AND ASSOCIATED FEDERAL REGISTER NOTICE PURPOSE-To obtain Commission approval of: (1) the staff's proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy (nU) Statement, if necessary; and (2) a Federal Reaister notice (FRN) of proposed rulemaking for publication to solicit public comments regarding 10 CFR Part 35 restructuring into a risk-informed, more performance-based regulation.

CATEGORY:

This paper addresses significant rulemaking issues requiring Commission consideration and approval.

BACKGROUND:

The Commission, in its " Staff Requirements Memorandum (SRM) - COMSECY 96-057, Materials / Medical Oversight (DSI 7)," directed the staff to submit a program, for Commission approval, for revising Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement (Attachment 1).

CONTACTS: Catherine Haney, NMSS/IMNS SECY NOTE: TO BE MADE PUBLICLY (301) 415-6825 AVAILABLE AT COMMISSION BRIEPING f}

( ,/ Susanne Woods, NMSS/lMNS ON JUNE 13, 1997 (301) 415-7267 6+'3rb-

7 The Commissioners 2

( -

The staff was also directed to describe how Part 35 could be restructured into a risk-informed, more performance based regulation. In addition, a listing of issues was provided for staff consideration during development of the program. The staff reviewed the Commission's direction and is prepared to move forward with the revision to Part 35 and associated guidance documents.

' DISCUSSION:

The staff plans to establish a steering group and a working group. This approach is described in Management Directive 6.3, "The Rulemaking Process." The steering group will be comprised of representatives, at the Division Director level or higher, from the following offices: Office of Nuclear Material Safety and Safeguards (NMSS); Office of Nuclear Regulatory Research (RES); Office of the General Counsel (OGC); Office of Enforcement (OE); and Office of State Programs (OSP). The Director, Divicion of Industrial and Medical Nuclear Safety, NMSS, will chair the steering group. In addition, the steering group will include an Agreement State Program representative. The working group will be comprised of Nuclear Regulatory Commission staff and representatives from both an Agreement State and a non Agreement State.' Representation willinclude NMSS, RES, OGC, and OSP. The nominated Agreement State representative is also a member of the Conference of Radiation Control Program Directors (CRCPD), Inc., Suggested State Regulation Committee (SSR) on Medical Regulation. The staff plans to work toward parallel covelopment of the NRC rule and Q the CRCPD suggested state regulations to facilitate state development of their corresponding Q rules.

Attachment 2 describes the staff's proposed program for the revision to Part 35 and associated documents. The staff plans to use a fresh start approach, soliciting initialideas and suggestions from the medical community and the public. Previously identified issues will also be factored into the revision, including: recommendations of the Indiana, Pennsylvania, incident investigation Team; recommendations from intemal staff audits; open rulemakings and results of analyses in medicalissues papers.

The staff plans to use a process for revising Part 35 and associated guidance documents that provides more opportunity ior input from potentially affected parties than is provided for by the typical notice and comment rulemaking process. This process includes solicitation of public comment on several occasions. The first opportunity begins with the publication of an FRN (Attachnent 3) that solicits initial input into the development of Medical Policy Statement options and regulatory attematives. To the extent possible, commentors will be asked to provide specific examples of draft rule language. During this period, two public meetings are planned to further solicit the initial public input. The second opportunity for public input will include a public comment period and a set of facilitated public meetings based upon draft rulemaking attematives. The staff plans to provide the draft rule attematives to the Commission prior to soliciting comment. During these meetings the staff will work with participants to review and refine the details of the proposed rule. Based upon the results of these public interactions, a proposed rule, regulatory analysis, and environmental assessment

'The Organization of Agreement States recommended that the non Agreement States be represented on this working group.

r

/ T The Commissioners 3 V

will be prepared, along with draft guidance documents. Following Commission approval, the proposed rule will be published for comment, and a second set of facilitated public meetings would be completed. The meetings are expected to be focussed upon areas of controversy, and upon the draft guidance, as a mechanism to refine the rule and guidance into final form.

The revision of the medical regulations will be a complex and controversial process, because of the diversity of activities, modalities and risk that fall within the umbrella of medical use, the corresponding diversity in medicel community positions, and the varied availability of professional codes and standards. Given these facts, the proposed program represents an aggressive schedule. The staff emphasizes that the proposed plan does not account for any possible requests for extensions on public comment periods associated with the initial FRN, the notice requesting comment on the rulemaking attematives, or on the proposed rule.

Requests for comment extensions cannot be granted without causing a change to the end dates for the final rulemaking. The staff projects that the final rule will be published in April 2000 (Attachment 2).

The staff plans to provide NRC's medical licensees, professional medical societies, and the Agreement States (for distribution tu their licensees) with copies of the initial FRN of proposed rulemaking. The staff plans to meet with and solicit comments from several professional societies, including, among others: (1) Society of Nuclear Medicine; (2) American College of Nuclear Physicians;(3) Health Physics Society;(4) American O Association of Physicists in Medicine; (5) the American College of Cardiology; and (6) the Q American College of Radiology. The staff will also attempt to identify pat;ent's rights groups and forward them copies of both the FRN and applicable documents for their comment. To this end, the staff arranged for a two-hour discussion with the American College of Nuclear Physicians and Society of Nuclear Medicine at their combined meeting in San Antonio, Texas, on June 4,1997. The staff intends to make documents pertaining to this rulemaking and electronic comment submittal available on the Intemet, using a separate page within the current RES rulemaking bulletin board.

Contractors and consultants are expected to assist the staff during the rulemaking process.

Contractors, in particular, will be used to consolidate public comments and prepare the

. regulatory analyses for the revised rule. In addition, the staff will pursue the use of technical meoscal experts as consultants to the working group. Specifically, the project is expected to enlist experts for diagnostic and therapeutic uses of radioactive material. Further, the use of contracted facilitators for public meetings is being considered, in addition to the support of the OGC Special Counsel for Public Liason and Agreement State Programs.

The staff blieves that, at this time, providing the Commission with a description of how Part 35 can be restructured, without the benefit of public comment, is premature and that it may lead stakeholder groups to believe that the staff has already decided on a particular approach. ideas generated at the first stages of comment will be validated and tested during the subsequent facilitated public meetings planned for spring 1998 and early 1999. The result will be the staff's proposed rule and associated guidance for Commission consideration (p) v in December 1998.

The staff used the guidance in the Strategic Assessment Direction Setting issues Papers Number 7, ' Materials / Medical Regulations,' and Number 12, " Risk Informed, Performance-

( The Commissioners 4 Based Regulations," as well as the SRM (COMSECY 96 057) to prepare a proposed FRN and associated press release (Attachments 3 and 4). The FRN of proposed rulemaking contains a list of issues, presented in the form of questions, for consideration by the public.

The staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented.

Rather, the overriding issues are both the identification of necessary changes (additions and deletions) to Part 35 requirements and the 6ssessment of risk for a risk informed, more performance-based regulation with sufficient oversight of public health and safety. The staff also poses the question of whether quantitative or qualitative enteria should be considered in determining the " risk" for each modality. Public comments, the Commission SRM issues, and the staff reports on medicalissues (as previously noted) will be used for developing the framework and associated text of the proposed rule.

The staff discussed revision of Part 35 with the Advisory Committee on the Medical Usos of isotopes (ACMUI) at the April 1997 Committee meeting. As a mechanism for generating discussion during the last two public meetings of the ACMUI, the staff identified a possible approach for restructuring Part 35 by modality (e.g., teletherapy, radiopharmaceutical therapy), based upon risk. ACMUI comments addressing the Part 35 revision are summarized in the proposed FRN (Attachment 3). The ACMUl's discussion will be available as additional background information for public commentors, and will be considered by the working group in preparing rulemaking proposals. The staff intends to continue active involvement of the ACMUI in the ongoing development process, including Committee Os meetings, additional reviews of guidance documents developed during the Part 35 revision process, and possible supplemental technicalinput from ACMUI subcommittees.

RESOURCES:

The Offices of Nuclear Material Safety and Safeguards, Research, General Counsel, and State Programs have identified the following resource requirements for this effort in their recent budget submissions. These resource levels will be considered in the FY 1999 budget review process.

FY 1998 FY 1999 FY 2000 Office SE IIE lE IIE SE _EIE NMSS 39 3.0 60 3.0 0 0.3 RES 150 1.9 50 1.0 OGC* 0 0.3-0.6 0 0.3-0.6 OSP O 0.5 0 0.5

'OGC effort includes any process design and the possible option of facilitation support for the public meetings from the Special Counsol for Public Liaison and Agreement State Programs.

NMSS management will monitor resource use closely for this rulemaking.

The Commlusioners 5 RECOMMENDATION:

That the Commission approve the following: (1) the proposed Part 35 revision program; (2) issuance of the attached FRN; and (3) the attached press release.

CQQRDINATION:

l OGC reviewed this paper and has no legal objection. The Chief Financial Officer has no objection to this paper. The Office of Chief information Officer has reviewed the plan for l information management implications and concurs in it; however, since the revision to 10 CFR Part 35 contains information collection requirements, it must be submitted to the Office of Management and Budget for review no later than the date the proposed rule is published in the Federal Reaister.

OL L.Jo- ph Callan Executive Director for Operations O Attachments: 1. SRM dated March 20,1997

2. Program for Revising 10 CFR Part 35 and Associated Documents

3. Proposed Federal Reaister notice

4. Dress Release DISTRIBUTION:

Commissioners OGC OCAA t

OIG OPA OCA CIO CFO EDO ~

SECY Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Friday, June 20, 1997.

Commission staff office comments, if any, should be submitted n to the Commissioners NLT June 13, 1997, with an information copy (d

T to the office of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

)

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- ,, NUCLE AR REGUL ATORY COMMISSION .ordan

I wasswotcw.oc m n e Norry Blaha

(..... &-ch 20, 1997 Bangart, SP 055. M sacartm MEMORANDUM TO: L. Joneph Callan Exe ut ve D rector for Operations b Secretary FROM: Job C. oy e,

SUBJECT:

S AFF REQUIREMENTe - COMSECY-96-057 MATERI/1S/ MEDICAL OVERSIGHT (DSI 7)

With respect to the overall materials program, the Commission continues to support its pte.iminary views on this issue which were a combination of two options -- Continue the Ongoing Program 7x with Improvements (Option 2) and Decrease oversight of Low-Risk

( ) Activities with Continued Emphasis in High-Risk Activities

' / (Option 3). For the longer term, the conmission also believes that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher-risk activities identified in option 1.

With respect to the medical pr .-'am, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regula #.on of ionizing radiation in medicine. The Commission continues to oelieve that the conclusions in the report were not substantiated and that tha recommendations should not be pursued.

The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulutory_ guides and standards as was proposed in the Commission's preliminary views. In the longer term, the Commission would be willing to consider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.

s In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission

("' ) approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary. The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the 4emvar,-program tvw av w 2n, the y staff should consider the following:

1: Focusing Par: !! :n :n:se pr: red.res :na: ::se One .

h:ghest r:sk.

(2) For daagnostic procedures, staff should cent. der regulatory oversigl.: alternatives consistent with the lowsr overall risk of these Procedures.

(3) The staff should address how best to capture not only relevant safety-significant events, but also precursor events.

(4) Changing the nomenclature from " misadministration" to "mectical event" or comparable term!nology.

(5) Part 35 should be redesigr.ed so that it can incorporate necessary regulatory requirements for new treatment modalaties in a timely mannu..

.6) The Quality Manage:..ent Prcgram provisions (10 CFR Part 35.32) should be re-evaluated and revised Oc focus en those requirements that are essential for patient safety, e.g., confirming patient identity, requiring

\s written prescriptions and verifying dose. To the maximum extent possible, the requirements should be revised to be risk-informed. Given this objective, a mixed approach of performance-based rules and otherwd.se prescriptive regulat ians shceld be pursued.

(7) The staff should consider the viability of using or referencing available indust y guidance and standards that within Part 35 and related 9.ioance to the extent they meet NRC needs.

(8) The staff should consider a rulemaking process that provides more opportunity fer input from potentially affected parties than is provided by the normal notice and comment rulemaking process but would be less

- consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination.

The staff's program to implement the above should be submitted 6,- 1997.

to the Commission for its consideration no later than June The program abould target fune 30, 1999 as the dateand This rulemaking for

,7-~ completing associated guidance the rulemaking process.is a very high priority for the development

' Commission. The Commission is prepared to provide additional resources to'the extent necessary to complete the rulemaking process on this rehedule.

6/6/97) 970006 (SECY Suspense (NMSS/RES) (EDO - Program) (SECY Suspense: 6/30/99) 970006 (NMSS/RES) (EDO - Complete Rulemaking)

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