ML20217G000
| ML20217G000 | |
| Person / Time | |
|---|---|
| Issue date: | 10/20/1999 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| Shared Package | |
| ML20217G006 | List: |
| References | |
| NACMUI, NUDOCS 9910210152 | |
| Download: ML20217G000 (38) | |
Text
{{#Wiki_filter:I BRIEFING BOOK Advisory Committee on the Medical Uses of Isotopes- : October 20,1999 l gD ; C# 'cp, v[ foA *100E0 E EUS PDR
l 1 i , ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTCPES ) October 20,1999 2:00 - 5:00 p.m. U.S. Nuclear Regulatory Commission Two White Flint Building - T2D3 Rockville, Maryland AGENDA
)
2:00 p.m. - 2:15 p.m. Opening Remarks - Dr. Donald Cool, Director, Division of industrial and Medical Nuclear Safety Overview and Status of the Rulemaking - Cathy Haney, Chairme,, Part 35 Working Group 2:15 p.m.-2:45 p.m. Self Evaluation of the ACMUl i 2:45 p.m. - 3:00 p.m. BREAK-3:00 p.m. - 5:00 p.m. Preparation for the October 21,1999 Commission Briefing on the Revision of Part 35, Medical Use of Byproduct Material i e O
E l- i 1. 1 ' f% UNITED STATES NUCLEAR REGULATORY COMMISSION Cll
.Q' - COMMITTEE 463)'
ON MEDICAL USES OF ISOTOPES (Pursuant to Section 9l 1
- 1. Advisory Committee on the Medical Uses.of isotopes:
i (Committee's Official Designation) l
~2. Committee's objectives, scope of activities and duties are as follows:
Th'e Committee provides advice, as requested by the Director, Division of j Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and l q Safeguards, on policy and technical issues that arise'in regulating the medical use : of byproduct material for diagnosis and therapy. The appointed Chairman of the Committee will conduct all meetings and will prepare rmnutes summarizing the l deliberations of each meeting. The minutes willinclude the Committee's recommendations for future actions. Subcommittees may be convened to , address specific problems when it is not necessary for the full Committee to be ! present.
- 3. Time period (duration of this Committee):
. From April 4,1998, to April 4,' 2000
- 4. Official to whom this Committee reports:
- Donald 'A'. Cool, Director ,
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards , i U.S. Nuclear Regulatory Commission Washington, DC 20555
, 5. ' Aaency responsible for providina'necessary support to this Committee:
U.S. Nuclear Regulatory Commission
- 6. The duties of the Committee are set forth in !!em 2 above. l
- 7. Estimated annual direct cost of this Committee:
- a. $160,466.00 (includes travel, per diom, and compensation)
- b. Total staff year of support: 1.3 FTE ,
- 8. Estimated number of meetinas per year: l Three meetings per year except when active .u;emaking is conducted, then five U ;
meetings per year.
' j i
1 l': Charter, ACMUI
- 9. . The Committee's termination date if less than two years, from the date of establishment of renewal:
April 4,- 2000 l
- 10. Filina date:
'hmv * /3 /9fY 2 w. ~< # w Andrew L. Bates ,
Advisory Committee Management Officer Office of the Secretary of the Commission
- i l
J l l
. j t
I i
.t ,
j .,
Feder:I Register /Vol. 64. No.192/Tu sday, October 5,1999/ Notices 54057
, III. Current Actions of the Bureau of Labor Statistics These surveys will be mailed in late FY l . [m\ Behavioral Science Research Center. 2000, and will be used to select
(") The Department of Labor is developing an Equal Opportunity Survey in order to improve its This assures that the definitions and instmetions are clearly written and can establishments for compliance evaluations during FY 2001. Thereafter implementation of the laws enforced by be readily understood. Suggestions for OFCCP intends to survey contractors on OFCCP: Executive Order 11246, as improving the clarity of the form have an annual basis. amended:Section 503 of the been incorporated into the current Type o/ Review: New Collection. Rehabilitation Act of 1973, as amended: version. This part of the process began Agency Employment Standards and the affirmative action, provisions of m August 19e s and was completed in Administration. tember 1s]9.
Title:
Equal Opportunity Survey. the Vietnam Era Veterans Readjustment se[etween October 1999Affected Assistance Act of 1974, as amended. 38 and January Public: Businesses or other U.S.C. 4212. The three-part survey, as 2000 the Department will field test the for-protit: Not-for-profit institutions: currently envisioned, would collect survey instrument. This field test, State. Local or Tribal Government. general information on the status of the conducted on a voluntary basis, will be Tota 1 Respondents: 60.000. designed to test the procedures used Frequency: Annually. federal contractor s affirmative action plan and aggregated personnel and when the survey is implemented and Total Responses: 60.000. compensation data, with a breakdown will inchyle a follow-up component for Estinwted Time Per Response:12 both respmdents and nonrespondents. hours. by gender and minority status. Each year, OFCCP will collect survey The fuld test will be conducted by Estimated TotalBurden Hours: OFCCP with the assistance of BLS. 720.000. data from federal contractors who are Tora 1 Burden Cost (capital /startup): 0.
. subject to the laws enforced by the Following the 'leid test, appropriate revisions will be made to the survey Tota 1 Burden Cost (operating /
agency. DOL s goals for the survey are: maintenance): $60,000. instrument. The final report of the to increase compliance with equal Comments submitted in response to results of the field test and the surve y employment opportunity requirements this notice will be summarized and/or by improving contractor self-awareness; in final form will be included with t. e final ICR submission to OMB in January included in the request for Office of to improve the deployment of scarce 2000. Management and Budget approval of the federal government resources toward information collection request: they will contractors more likely than not to be in Phasell-Survey also become a matter of public record. noncompliance; and to increase agency At this time OFCCP intends to 5" 1 efficiency by building on the tiered- Dated: September 30.1999. the survey to contractor establishments Margaret J. Sherrill review process already accomplished by that are " flagged
- by OFCCP's Equal OFCCP s regulatory teform efforts. Employment Data System (EEDS) as Chief. Branch o/ Management Review and Interna 1 Control. DMsion offinancial
[]
; y thereby allowing better resource allocation.
being potentially out of compliance with Executive Order 11246. An initial Management. Ottice o/ Management. Administration andPlanning. Employment
\"f In consultation with the Office of Management and Budget (OMB). DOL mailing of the survey will be made to Standards Administration.
respondents selected from those (FR Doc. 99-25811 Filed 10-4-99: 8:45 am) has developed a plan for phasing in the establishments that were flagged in ,,1,,o cong .,,,,_, implementation of the Equal 1999. Approximately 7,000 of the Opportunity Survey. As part of the flagged establishments will be surveyed developmental process, the instrument in April 2000. This number was chosen first is being tested using procedures NUCLEAR REGULATORY to provide a sufficient sample to test the established by the Bureau of Labor COMMISSION data intake and processing procedures. Statistics to assure that it is structured Flagged establishments will be selected Advisory Committee on the Medical in a manner that respondents for the survey based on geographic Uses of isotopes: Meeting Notice understand and that the data OFCCP is location and size. seeking are readily available. The survey data from the initial AGENCY: U.S. Nuclear Regulatory Once the survey development process mailing will be processed and analyzed Commission. has been completed, the survey will be and the results used to identify ACDON: Notice of meeting. phased in using two mailings in FY establishments for compliance 2000. The phase-in process will allow evaluations. The analytical model will
SUMMARY
- The U.S. Nuclear Reg.ilatory updating of the flagged contractor list result in a ranking of contractors based Commission (NRC? will convene a with the new EEO-1 data expe cred in on the nature and number of adverse meeting of the Advisory Committee on the summer of 2000. It will also permit indicators. Compliance evaluations will the Medical User ofIsotopes (ACMUI) modifications to be made to data be scheduled beginning with those on October 20.1999. The meeting will processing procedures to assure timely establishments with the highest take place at the address provided processing, rankings on the indicator scale. As part below. All sessions of the meeting will of the compliance evaluation process, be open to the public. Topics of Phase I-Surveylnstrument revision survey responses will be validated for a discussion willinclude: (
Development sample of establishments to assure that of the NRC's medical regue.tso,ns. in During this phase the survey accurate data are being submitted. Preparation for the Committee s instrument will be put in final form and Establishments where compliance participeW.1.the October 21.1999, tested for clarity; the analytical model evaluations are not initiated may be Crnnmission briefing on 10 CFR Part 35 will be developed; and. Initial notified of areas that require additional (64 FR 44965); and (2) the Committee s ; consultation with an outside contractor self-analysis. self-review, using the criteria previously on survey processing procedures will The second mailing will be sent to the developed to evaluate the performance
/ take place. flagged establishments that were not of the Committee.
k The draft swvey instrument has been previously surveyed in the first mailing DATES:The meeting will be held from 2 k tested and evaluated using the facilities (i.e. about 53.000 establishments). to 5 p.m. on October 20,1999.
]
l 54058 Federcl Register /Vol. 64, No.192/Tuesdry, October 5,1999/ Notices 7.s ADDRESSES: U.S. Nuclear Regulatory Exchange Act of 1934 ("Act") and Rule For the Commission, by the Division of
/ \ Commission, Two White Flint North. 12d2-2(d) promulgated thereunder. to Market Regulation. pursuant to delega,ad (V) 11545 Rockville Pike. Room T2B3, Rockville, MD 20852-2738.
withdraw the security specified above (" Security") from listing and authority. Jonathan G. Katz, FOR FURTHER INFORMATION CONTACT: registration on the American Stock Secretary. Diane Flack, U.S. Nuclear Regulatory Exchange LLC (" Amex" or " Exchange"). IFR Doc. 99-25828 Filed 10-4-99; 8.45 aml Commission, Office of Nuclear Material The Security has been listed for snasm com e m Safety and Safeguards. Mail Stop T trading on the Amex and, pursuant to a F31. Washington DC 20555 Telephone Registration Statement filed with the (301) 415-5681. Commission on Form 8-A, became SECU S AND EXCHANGE Conduct of the Meeting de5fanated for quotation on the Nasdaq Manuel D. Cerqueira, M.D., will chair Stock Market. Inc. ("Nasdaq") on Investment Company Act Release No. the meeting. Dr. Cerqueira will conduct September 17.1999. Trading in the 24060;812-11740) the meeting in a manner that will shares of the Security on the Nasdaq commenced at the opening of business J.P. Morgan Securities Inc.; Notice of facilitate the orderly conduct of Application business. The following procedures on September 23,1999. apply to public participation in the In making the determination to September 29,1999. meeting: transfer the trading of shares ofits AGENCY: Securities and Exchange
- 1. Persons who wish to provide a Security from the Amex to the Nasdaq. Commission ("SEC").
written statement should submit a the Company, whose primary business ACTION: Notice of application for an reproducible copy to Diane Flack relates to technology, has stated its order under section 12(d)(1)(J) of the i (address listed previously), by October belief that there exist greater potential Investment Company Act of 1940 (the ' 12.1999. Statements must pertain to the benefits to its shareholders from trading "Act") for an exemption from section topics on the agenda for the meeting. on the Nasdaq. 12(d)(1) of the Act, under section 6(c) of
- 2. At the meeting, questions from The Company has complied with the the Act for an exception from section members of the pubite will be permitted rules of the Amex by filing with the 14(a) of that Act, and under section at the discretion of the Chairman. Exchange a certified copy of the 17(b) f the Act for an exemption from ;
- 3. The transcript and written secu n 17(a) of the Act.
preambles and resolutions adopted by comments will be available for its Board of Directors authorizing the inspection, and copying for a fee, at the
SUMMARY
OF APPUCATION:J.P. Morgan withdrawal of the Security from listing Securities Inc. ("J.P. Morgan") requests NRC Public Document Room. 2120 L on the Amex, and by setting forth in Street, NW, Lower Level, W ashington an order with respect to the MEDS trusts detail to the Exchange the reasons and ("MEDS Trusts") 8 and future trusts that
; 3 DC 20555, telephone (202) 634-3273, on or about November 22,1999. Minutes of supporting facts for such proposed are substantially similar to the MEDS (wj the meeting will be available on or withdrawal.The Amex has in turn Trusts and for which J.P. Morgan will about December 20.1999. informed the Company that it would not serve as a principal underwriter Interpose any objection to the (collectively, the "Truscs") that would
- 4. Seating for the public will be on a Company's application to withdraw its (1) permit other registered investment sr e in i be d in Security from listing and ngistration on companies, and companies excepted accordance with the Atomic Energy Act the Exchange. from the definition ofinvestment of 1954, as amended (primarily Section The Company's application relates company under section 3(c)(1) or (c)(7) 161a); the Federal Advisory Committee solely to withdrawal ofits Security from of the Act, to own a greater percentage Act (5 U.S.C. App): and the listing and registration on the Exchange of the total outstanding voting stock (the Commission's regulations in Title 10. and shall not affect the Security's Securities ') of any Trust than that U.S. Code of Federal Regulations, Part 7. designation for quotation on the Nasdaq. Permitted by section 12(d)(1), (11)
By reason of Section 12(g) of the Act exempt the Trusts from the initial net Dated: September 29.1999. and the rules and regulations of the worth requirements of section 14(a), and Andrew L. Bates' Commission thereunder, the Company (111) Permit the trusts to purchase U.S. Advisory Committee Management Olricer. government securities from J.P. Morgan shall continue to be obligated to file (FR Doc. 39-25796 Filed 10-4-99; 8:45 aml reports under Section 13 of the Act with at the time of a Trust's initial issuance saumo coot neNkP the Commission. of Securities. F1UNG DATES:The application was filed Any interested person may, on or on August 6,1999. Applicants have SECURITIES AND EXCHANGE before October 20,1999, submit by letter agreed to file an amendment to the i COMMISSION t the Secutary of the SecurWs and application, the substance of which is Exchange Commission. 450 Fifth Street- reflected in this notice, during the M Walisting; Notice of Application NW. Washington, DC 20549-0609, facts notice period. To withdrew From Listing and bearing upon whether the application HEARING OR NOTIFICATION OF HEARINo: An Registration;(HyperFood has been made in accordance with the orwr granting the application will be Technologies,Inc., Common Ston, rules of the Exchange and what terms, issued unless the SEC orders a hearing. S.001 Par Value) File No.1-11108 ff any, should be imposed by the Interested persons may request a Commission for the protection of hearing by writing tot he SEC's September 29,1999. Investors. The Commission. based on Secretary Lnd serving J.P. Morgan with HyperFeed Technologies, Inc, the information submitted to it, will a copy of the request personally or by
, (" Company") has flied an applicat on issue an order granting the application
/mh with the Securities and Exchange after the date mentioned above.unles-mail. Hearing request should be (v) Commission (" Commission"), pursuant the Commission determines to order a to Section 12(d) of the Securities hearing on the matter.
rMEDs" is an acronym for Mandatory Enhanced Dmdend secunties-
o p J' l
SUMMARY
MINUTES ADVISORY COMMIT a tt ON THE MEDICAL USES OF ISOTOPES MARCH 24-25,1999 The Advisory Committee on the Medical Uses ofIsotopes (ACMUI) held a meeting in Rockville, Maryland on March 24-25,1999. A briefing book, with background information for
< the issues under discussion, was provided to the ACMUI members in advance of the meeting, j and is available through the Public Document Room.
4 i ACMUI members present at the meeting: Judith Arm Stitt, M.D., Chair l ' Manuel Cerqueira, M.D. John Graham (3/24 only) Nikita Hobson . Andrew Kang, M.D. Ruth McBumey, M.S., CHP 3 William B. Nelp, M.D. (3/25 only) , Dennis P. Swanson, M.S., B.C.N.P Iouis K. Wagner, Ph.D. ' Invited guests present at the meeting: i Bruce Bower, M.D., representing endocnnology perspectives
.f Larry Holder, M.D., representing nuclear medicine perspectives Richard Vetter, Ph.D., representing Radiation Safety Officer paspectives ,
Jeffrey F. Williamson, Ph.D., representing medical physicists perspectives I Nuclear Regulatory Commission staff present at the meeting:
~ Cathy Haney, Section Leader, Rulemaking and Guidance Branch (RGB), IMNS, NMSS and Chatt of the Part 35 Working Group (Designated Federal Official for the Committee)
Donald Cool, Ph.D., Director, Division ofIndustrial and Medical Nuclear Safety, NMSS Robert Ayres, Ph.D., Materials Safety and Inspection Branch, INMS, NMSS
~ Part 35 Working Group Members present at the meeting:
l Marjorie Rothschild, Office of t,w General Counsel PennyImrisera, Region 1 ' Diane Flack, RGB . Sam Jones, RGB . Tony Tse, RGB-
. Tom Young, Region III -
L Barry Siegel, M.D., medical consultant to the Part 35 Working Group l l~ l L
I
- OPENING REMARES
- Ms. Cathy Haney officially opened the meeting at 9:05 a.m. with general comments on the meeting agenda and the function of the ACMUI. Ms. Haney stated that she had reviewed the
, Committee members' fmancial and employment interests, and had not identified any conflict of
' interest with items to be considered during the meeting. Ms. Haney stated that any ACMUI member who becomes aware of a potential conflict ofinterest during the course of the meeting should inform her or Dr. Judith Stitt. Ms. Haney noted that the meeting was announced in the Federal Register on March 3,' 1999.
Donald A' Cool, Ph.D., made opening remarks to the Committee. Dr. Cool discussed the importance of the Part 35 rulernakmg to the Commission as an effort to move in the direction of. more risk-informed and performance-based regulations. He also expressed thanks to three i members of the Committee whose terms are ending later in 1999, Dr. Stitt, Mr. Dennis Swanson, I and Dr. William Nelp. 1 PREVIOUS ACMUI SUBCOMMITTEE RECOMMENDATIONS
' Ms. Haney updated the Committee on the activities of the Part 35. Working Group since the q
. ACMUI diagnostic and therapeutic subcommittee rneetings in February 1999. She asked the l
' Committee members to review the minutes of the subcommittee meetings to ensure that the - 1 minutes adequately captured the recommendations of the subcommittees. She indicated that the r Working Group had incorporated most of the recommendations of the subcommittees into the i revised draft final rule that was provided to the ACMUIin advance of this meeting (hereafter . !
referred to as " draft fmal rule"). In a few cases, the Working Group wanted furtherinformation , or dialogue ~ with the Committee about certain recommendations, i I TIMELINE FOR REVISION OF 13 CFR PART 35 AND ASSOCIATED ACTIVITIES Ms. Haney summanzed the Part 35 rulemaking activities leadmg up to the present meeting. She also explained that following this meeting the NRC staff and the ACMUI would brief the
' Canminion on the draft final rule. Following the briefmg, the rule would be revised to l inceiper.ie any ACMUI recommendations, unless the Commission had previously stated a ;
position that was not consistent with the ACMUI recommendations, e.g., patient notification. i This version of the rule would then be provided to the other NRC offices for review and : concunence. Comments from the other NRC offices would be returned by early May. She j indicated that the final rulem*ing package'was due to the Commission by June 1999. Finally, she indicated that during the summer and fall of 1999, the Pa:t 35 Working Group expects to focus on fmaliring the guidance document associated with Part 35 (NUREG 1556) and the ;
' Medical Policy Statement.
l j
I i t : i REVIEW OF KEY ISSUES IN PART 35 WORKING GROUP'S DRAFT FINAL RULE Ms. Haney explained that the Working Group had identified specific issues where they would ; like ACMUI review and comment. This review would assist the Working Group in finalizing the { draft final rule for Commission consideration & approval and in writing the Statements of Consideration.- 4 Section 35.292, Training for imaging and locali= tion. (Note that this section was changed to
. 35.290 in version being forwarded to the Commission) i Ms. Haney indicated that the traming and experience requirements in the proposed rule were focused on radiation safety. The duration of the training and experience program needed for individuals to become authorized users (AUs) for imaging and localization studies (i 35.200) was significantly reduced from the current rule (1,200 hours to 120 hours). In addition, requirements for an examination in radiation safety and a preceptor affirmation of competence was added to the training requirements for AUs, as well as for the authorized nuclear pharmacist !
(ANP), authorized medical physicist (AMP), and Radiation Safety Officer (RSO).
- ' Ms. Haney explained that the examination requirement was not included in the draft final rule, ;
! but a provision was added for NRC to review and approve training programs. She also explained l that the duration of the training program for use of byproduct material for imagmg and i Imh6on studies (f 35.200) was increased from 120 hours to 700 hours. (The traimag and ! l experience requir ments in the proposed rule are presented in Attachment 1. The trammg and I-experience requirements in the draft final mle are presented in Attachment 2.) A physician member of the public expressed concern that the trainmg and experience requirements for this category of AUs had been increased since the last public meeting. Ms. Haney explained that the classr<.,om and laboratory training (80 hours) and supervised practical experience (40 hours) would be considered a component within the 700 hours so the actual 1 increase was 580 hours. Dr. Cerqueira stressed that it was.important to ensure that the required I hours of training could be done concurrently (i.e.,120 within the 700). Dr. Siegel suggested that' eliminating the words "in basic radionuclide handling techniques" would help to clarify that the requirement for 700 hours includes the 120 hours (80 hours of didactic and 40 hours of handling [80/40 split]). Mr. Swanson suggested that the specificity of 80 hours and 40 hours within the 700 hours was too prescriptive, and recommended instead that the requirement be made more flexible by saying "700 hours of training and experience applicable to the medical use of unsealed byproduct material." Dr. Siegel argued that this would provide insufficient information to trammg organizations on the breakdown between classroom training and practical' work experience. Mr. Swanson then modified his recommendation to
. specify 700 bours of training "that includes 120 hours of training in the following areas: (1)
' didactic and (2) supervised practical experience."
p - o I
. ' Ms. McBurney suggested that specifying an 80/40 split in the 120 hours would allow Agreement States to make a determination on the =Aaquacy d the alternate training program. Mr. Graham suggested that without such specification, the entire 120 hours could be provided in a classroom.
Dr. Siegel agreed with Mr. Graham and suggested retaining the 80/40 specification. Dr. Williamson also agreed with the split. ' Dr. Wagner suggested that the requirement say."at least 80 and at least 40." Mr. Swanson moved to leave the proposed final rule language as written, retaining the 80/40 split, that is to leave (c)(1) and (c)(2) of this section with respect to the
. required hours, unchanged.
' Motion 1.1: leave 6.35.292(c)(1) and (c)(2), with respect to the required hours, unchanged.
Vote: 6 in favor, none opposed. Mr. Swanson expressed concem about the requirements for " supervised practical experience under an authorized user." He recommended instead that the reference should be to " experience under the preceptor," since in some cases, such as a centrahzed nuclear pharmacy, the work would not be done under the supervision of an authorized user. He also questioned whether ; supervision was the same as preceptorship. 'Dr, Siegel suggested that the program director would i be providing the supervision, while possibly delegating some of the responsibility for trainmg to !
- other persons.
Dr. Vetter supported the requuement for a preceptor. He was concerned that too narrow a restriction would make it impossible for an individual to go elsewhere to obtain specific elements of training. Dr. Wagner suggested that the requirement might be for supervised practical experience approved by a preceptor. Dr. Cerqueira also expressed concem that a cardiologist might obtain clinical training and experience in an Accreditation Council for Graduate Medical l Education (ACGME) program, but go outside for didactic training. In that case, the clinical preceptor would have little authority or supervision over the outside program and two preceptor s signatures might.be needed. Ms. Haney explained that the preceptor will be required to certify l that the individual is competent to function independently as an AU and, therefore, two ; signatures would not be needed. ' Dr. Williamson supported revising the definition of preceptor in $35.2. Dr. Siegel thought that changing i 35.292(c)(2) to specify'"under the direction of a preceptor" would be' sufficient, because the preceptor would be taking the overall responsibility of ensuring that the individual L had mastered the necessary material, and " direction" rather than " supervision" is a looser term. Mr; Graham asked if a medical physicist or pharmacist could serve as~a preceptor, and was referred to the requirement that the preceptor must meet either 635.292 or i 35.390, which means
- he or she must be an AU.~ Dr. Cerqueira recommended using the term " preceptor authonzed user" in (35.2^2(c)(2) and (c)(3) for clarity. .
E Mr. Swanson sug,gested that the term " radioactive dmg"in the introductory statement to i 35.292
'should be raaM Ms. Haney explained that the term radiopharmaceutical did not include Q(~'T .
o biologics, and thersfore " radioactive drug'.'.was more appropriate.~ However, she noted, the FDA 7 definition of radioactive drug could not be used because Part 35 only addresses usetf byproduct material. Mr. Swanson noted that in some contexts, even in Part 35, the term should aot be .
' limited to byproduct material. For example, the 700 hours of training and experiencu received by an individual should not be limited to byproduct material because it could include accelerator-
' pradnead material, such as thallium. He also noted that in other contexts, use of the broad term
- " radioactive drug" may not be appropriate unless it is modified by "containing byproduct material."
Mr. Graham moved to revise f 35.292(c). He moved that the phrase "in basic radionuclide handling techniques'.' be deleted and the term " radioactive drugs" be substituted for the term _j
~ " unsealed byproduct material"in the introductory sentence of(c). He also moved that the word '
" direction" be substituted for the word " supervision" and the term " authorized user" be replaced with the term " preceptor authonzed user" in paragraph (c)(2).
Dr. Vetter was concerned that nuclear pharmacists and RSOs may some to an institution having l already had their didactic training, and, therefore, the preceptor could not have "duected" that training. Dr. Wagner noted that it is a question not only of duection, but also of approval of the treining. Mr. Graham argued that the preceptor does not have to direct all the training, but only I must be satisfied that all the training is mecaptable; Dr. Cerqueira was concerned that the l ' certifying preceptor could not always verify competence in any training received outside the pmgram. Therefore, more than one preceptor statement might be necessary for individuals who O do not obtain board certification, but instead seek AU status via the alternative pathway. Dr. Siegel noted that even medical boards do not require multiple program directors to attest to
]
. satisfactory completion of training. Dr. Wagner noted that the rule language should be revised to stated "under the duection of a preceptor" rather than "under the duection of the preceptor." l This change would clarify that the preceptor who signs the certification does not need to direct all l of the training. &candly, he recommended replacing the phrase "under the duection of" with the i phrase "appmved by" to add flexibility. *
' Drs. Cerqueira and Siegel discussed the likelihood that an individual would plan his or her training in advance and use traming programs approved by NRC or whether he or she would receive traimng in different places at different times. Dr. Siegel suggested an individual using a non-traditional approach could seek advance NRC approval. Dr. Cerqueira questioned if a mechanism existed for such approval.- Ms. Haney noted that ACMUI assistance would be requested in approving training programs. She also asked whether NRC needed to approve the
- 120 hours of classroom and laboratory training and the balance of the 700 hours. Dr. Siegel ;
believed that NRC does need to approve the entire 700,just as it would for an ACGME-approved
' l Program. ,
l
; Mr. Graham argued that an individual'should have the flexibility of obtaining traming under the direction of multiple preceptor AUs. He moved to amend the pending motion to delete the term l
' " authorized user physician" as preceptor and instead use the term " preceptor authorized user."
i O )
- Motion 1.2: ' ..
I 1. ~ Section 35.292(c), introductory sentence - The phrase "in basic radionuclide handling techniques" should be deleted and the term " radioactive dmgs" should be substituted for the term " unsealed byproduct material." 1 2. - - Section 35.292(c)(2) - The word " direction" should be substituted for the word
" supervision" and the term " authorized user" be replaced with the term " preceptor authorized user."
- 3. l Section 35.292(c)(3) - The phrase "an authorized user" should be replaced with the phrase " preceptor authorized user" and the word " physician" should be deleted.
Vote: 7 in favor, none opposed. e Section 35.392, Training for use of sodium lodide I-131 for which a written directive is
. required. (Note that this section was divided into 35.392 and 35.394 in the version being forwarded to the Commission.) -
; Mr. Swanson expressed concern that an individual who is' authorized under 6 35.392 for the use .
. ofI-131 could prepare I-131 capsules with only 80 hours of training. Dr. Siegel pointed out that -
- the individual could not prepare the capsules because they are neither an ANP nor an AU under
, ) i 35.292. He indicated that an individual licensed under i 35.392 can only use a drug that is received from an organization licensed under i 32.72 or prepared by an ANP or an AU who meets the requirements in i 35.292. Dr. Siegel indicated that an AU who only meets the O requirements of f 35.392 cannot direct anything be done to a drug received from a i 32.72 supplier. Mr. Swanson then moved that i 35.300(b) be amended to say: "who meets the
-- requirements specified in il 35.292. 35.390, or an individual under the supervision . . . "
Ms. McBumey noted that the Conference of Radiation Control Program Director's, Inc.,
'_( CRCPD) working group developing State regulations had expressed concem to her about inconsistency between the training and experience requirements in il 35.292 and 35.390. They were concerned that the draft final training requirements for individuals that would like to use I-131 far treatment of hyperthyroidism and thyroid cancer were insufficient. Dr. Bower noted that I-131 dosages are admmistered orally, and have a low risk profile. It was also noted that the training and experience requirements in the proposed rule would have resulted in increased trammg iequirements for an individual who would like to be authorized to naminister only I-131 for hyperthyroidism or thyroid cancer.' Finally,'it was noted that the endocrinology community did not think the increase was warranted in light of their impeccable safety record under the current 80 hour traming requirement. -
Motion 2: Modify i 35.300(b) to state: "who meets the requirements specified in 66 35.292,
' 35.390, or an individual under the supervision . . . "
Vote: 7 in favor,none opposed.
\ n l
~
,dp :IntravascularBrachytherapy' -
Dr. Cerqueira suggested that intravascular brachytherapy should be classified under f 35.1000, "Other medical uses of byproduct material or radiation from byproduct material," as an emerging ,- technology. Ms. Haney noted that intravascular brachytherapy is cunently addressed under the requirements for brachytherapy, and that the draft final rule does not explicitly classify intravascular brachytherapy as an emerging technology. She explained that the trammg and - experience requirements for intravascular brachytherapy will be addressed after the completion
' of the Part 35 rulernaing, and in the meantime will be handled on a case-by-case basis.
- Dr. Cerqueira rnade a motion that intravascular brachytherapy, for the prevention of restenosis in the vascular system, be classified as an emerging technology, pending the results of the ongoing l Food and Drug Adnunistration (FDA)/ broad trials. Mr. Graham suggested that the implications l forintravascular brachytherapy would be better understood if the topic was addressed as part of.a
- broader discussion of Subpart K. Ms. McBurney moved to table the motion.
- Motion 3: Table the motion to discuss intravascular brachytherapy for prevention of restenosis in
'the vascular system until discussion of Subpart K. -
Votei 6 in favor. Dr. Cerquiera opposed, believing it appropriate to discuss at this time. General Discussion - Training and Experience Requhementsi Alternative Pathway Chart g (Attach ===t 2) ~
) The Committee reviewed the chart that s . nM the traming and experience requirements for s
l
- the altemative pathway to obtain status as'an AU, ANP, AMP, or RSO (Attachment 2). I
^
Ms. McBurney expressed concern over the traimng requirements for an AU that would like to I
' use sodium iodide I-131 for hyperthyroidism and thyroid carcinoma. Dr. Wagner suggested, and l Dr. Siegel agreed, that explicitly stating that the requirements pertained only to oral admimstration ofI-131 would be desirable. i
" Motion 4: Approve the training and experience requirements - Alternative Pathway
~ (Attachment 2). -
i Vote: 7 in favor, none cyyosed. Section 35.24, Authority and nsponsibility for the radiation protection program.
, puicion safety commin~- (RSC)
Ms. Flack explained under $ 35.24(b) that an RSC is required if the inst ution has two or more
'different types of uses of byproduct material under Subparts E, F, and E The ACMUI therapy
^
7-
n subcommittee ha'd suggested inserting "or." Ms. Flack asked whether the different types of uses
~
would have to be in different Subparts, or whether an RSC should be required if there are different types of machines that are included in the same subpart, e.g., is an RSC needed if a
+
licensee only has a remote afterloader and a teletherapy unit. Mr. Graham explained that an RSC should not be required if there was only one type of use. Ms. Haney noted that " type of use" is used to reference use of byproduct material as specified in
- il 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000. As proposed in the draft fmal rule,if a licensee only used unsealed byproduct material in quantities that required a written directive (f 35.300), it would not be required to have an RCC. However, a licensee that used unsealed byproduct material in quantities that require a written directive (f 35.300) and manual brachytherapy (f 35.400) would be required to have an RSC.
Dr. Wilhamson noted that two units under i 35.600 would not be covered by the term '4ypes of l use." Dr. Wagner suggested aMmg a reference to two or more units under i 35.600, so that even two of the same type of units would require a RSC. Dr. Williamson advocated making the criterion two or more uses under i 35.600. Dr. Stitt suggested that the distinction between
" units" and "uses" should be clear.
4 type o use f t maten E, F Ho re s units under Subpart H should be required to have an RSC. Dr. Siegel suggested that uses under - . 1 Subpart K should also be included. Ms. Haney said that the need for an RSC under Subpart K - l
, should be addressed on a case-by-case hea it could involve a low risk activity. Ms. !
McBurney moved to modify the motion to state "two or more uses under E, F, and H." Motion 5.1: That i 35.24(b) be amended to state " Subparts E, F, and H or two or more types of units under Subpart H." l Vote: 7 in favor,none opposed. Dr. Siegel commented that the RSC's duties should be clarL*ied, to specify that the RSC is not
.- just responsible for the activities that mandate the RSC, but also for all other activities involving
-. the use of byproduct materials in the institution. For example, he explained,if an RSC is
, required because both Subpart E and Subpart H activities are permitted by the license, the intent
< is that Subpart D activities at the institution would also be covered by the RSC. Mr. Graham ;
moved to change i 35.24 to read: " establish a radiation safety committee to oversee all uses of l bypmduct material permitted by,the licensee."
. Motion 5.2: That i 35.24 be amended to'" establish a radiation safety committee to oversee all uses of byproduct material permitted by the licensee." ~
l i Votei7in favor, none opposed. O I
s Teroser-rv RmAintion Safety Officer (RSO) Ms Flack noted that the Working Group is revising i 35.24 to allow multiple temporary RSOs. I The Committee made no specific comments on this item. Section 35.27, Supervision. Ms. Flack stated that the Working Group considered it important to retain the requirements in { 35.27. Mr. Graham noted that ultimately the chief executive officer is responsible for the actions of everyone who is carrymg out any activity that is in any way covered by the hospital's license. He indicated that the draft final rule is correct - licensees are responsible for the acts and omissions of the supervised individual.' The Committee had no other comments on this item. Section 35.40, Written Directives. Ms. Flack asked the Committee to review i 35.40(b) that lists the information that must be included in written duectives. Dr. Williamson recommended that the rule should be revised to - state that a written directive for gamma stereotactic radiosurgery include the treatment site, total dose, and number of gamma stereotactic shots for each anatomically distinct treatment site. Other specifications, such as gamma angles and coordmates, should be placed in the treatment _ plan description. In addition, the written directive should specify number of target coordinale settings, not the target coordmate settings themselves. Dr. Stitt agreed. . Dr. Siegel asked whether the term " anatomically distinct treatment site" was consistent with the ' definition of treatment site in i 35.2. Dr. Williamson clarified that " distinct"in treatment
- planning meanc that the dose contribution fram site one is not considered in planning the dose to
' site two. Dr. Stitt agreed that the language was consistent and would not be burdensome. Dr.
Willimmean also stated that, to the best of his knowledge, the gamma stereotactic radiosurgery i device is only used for single fraction radiosurgery. Dr. Siegel asked if i 35.40(b) should specify route of administration. Dr. Vetter pointed out that _ i 35.392 already specifies oral adminis,tration, although for sources ofI-131 other than sodium i iodide, the route of administration should be specified.~ Mr. Swanson argued that under (b)(1), l the written duective could contain a dosage but not the identity of the radiopharmeautical. Dr. Siegel explained that a form would generally be used to identify the radiopharmaceutical as I-131 sodium iodide. Mr. Graham was unwilling to rely on a form, and argued in favor of adding the i radiopharmaceutical name,to the mimmum requirements for a written directive. The Committee !
-h ...kM that the rule should be modified to address these concerns. Specifically i 35.40(b)(1) should be revised to state: "for an admmistration of a radiopharmaceutical: the radiopharmaceutical, dosage, and route of admmistration." The Committee also agreed that the
)
balance of the list ofitems to be included in the written directive was acceptable. Dr. Williamson noted that for remote afterloading brachytherapy, the written directive must ' A- j
l l 4 include the radionuclide, treatment site, dose per fraction, number of fractions, and total dose. I He did not believe the requirements for a low dose-rate (lDR) remote afterloader were appropriate, since the logistics ofloadmg the' sources, and doing the treatment planning before
; the treatment is complete, are identical to the requirements for manual brachytherapy. He believed the requirements'should be modified to group the requirements for manual brachytherapy with the requirements for pulsed dose-rate (PDR), medium dose-rate (MDR), and LDR remote afterloaders! Dr. Stitt agreed.
Section 35.63, Determinattan of dosages of unsealed bypraluct material for medical use. ! Ms. Haneyindicated that the' definition for prescribed dosage, as specified in the proposed rule, did not preclude the AU from prescribing a dosage range. In addition, the requirements for written directive in 6 35.40 do not preclude an AU from prescribing a dosage range. She also indicated that i 35.63 provides for a 20% deviation between the prescribed and administered - dosage. I Dr. Siegel suggested that the rule allow the AU to prescribe a dosage range. He went on to state
. that if the dosage is specified as a range, the administered dosage must fall within that range. !
Whereas if the dosage is specified as a single number, the mammistered dosage should be within i 20% of the prescribed dosage. Dr. Vetter questioned whether such a broad latitude would be wise from a radiation safety perspective. Dr. Siegel noted that a physician has latitude to ' prescribe a dosage range. Dr. Wagner questioned whether the requirement that admmistered dosages be wi 20% of the ! prescribed dosage was limited to administrations that require a written directive. He believed a ; 20% range was acceptable for diagnostic dosages but might not be acceptable for therapeutic j doses or dosages.' Dr. Williamson noted that the praedce was not to prescribe dose ranges when j using sealed therapy sources.; Typically, the radiation oncologist specifies a single dose. Dr.
~
Williamson was'concemed that allowing AUs to specify a range would cause an increase in treatment delivery errors. Dr. Stitt agreed that a specific dose was' desirable for therapeutic uses, I although flexibility for diagnostic uses made sense. .
. Mr. Swanson moved to amend 6 35.63(d) to allow a licensee to administer dosages that do not differ from the prescribed dosage by more than 20% or dosages that fall within the prescribed dosage range, unless otherwise directed by the AU. 4 The Committee discussed at length whether a dosage range should be allowed for unsealed byproduct material that requires a. written directive. Dr. Wagner moved to make the distinction according to whether or not a written directive is requued.
Mr. Swanson argued that this approach duectly interfered with the practice of medicine and implied a level of accuracy and dosage determinations with unsealed byproduct material that E . does not exist. Dr. Wagner agreed that the issue is defining the boundary between radiation s P 4
I safety and interference with good medical practice. Dr. Williamson was concerned that by i
\ allowing a range for certain modalities, an incentive could be created for practitioners to abandon ;
time-honored practices of prescribing a single number in order to avoid potential problems of- l regulatory enforcement. Dr. Wagner sought to clarify the motion.. He wanted to specify that ranges should not be allowed for the medical use of byproduct material where a written directive is required. Drs. Wagner and
- Siegel noted examples of situations in which a 20% range could be too narrow. In some cases, '
administrations could fall outside this range but still be within acceptable medical limits. l 1 Ms. Haney summarized the motion as follows: 3 Motion 6: NRC regulations should reflect the following:
- 1. An authorized user may prescribe a dosage range for material administered under if 35.100,35.200, and 35.500.
- 2. An authorized user may not prescribe a dosage range for material admmistered under {f 35.300,35.400, and 35.600.
i
- 3. Administered activities can deviate from a prescribed dosage by 20%.
i The Conmdttee decided not to address the issue of a dose range for material used under if 35.400 or 35.600. Vote: Motion withdrawn. i ( Motion 7: Amend i 35.63(d) to state that unless otherwise directed by the AU, a licensee shall not use a dosage if (a) the dosage differs from the prescribed dosage by more than 20% or (b) the dosage does not fall within the prescribed dosage range. Vote: 7 in favor, none opposed. Section 35.3045, Reports of medical events. Ms. Flack summarized the requirements for medical event reporting, noting that the Working , Group revised the requirement to exclude reporting of events that occur as a result of patient intervention, unless a physician detennines that the event resulted in permanent function damage to an organ or a physiological system. Ms. Flack also explained that wrong treatment site now involves a dose to the skin or an organ or tissue, other than the treatment site, that exceeds 50
. rem to an organ or tissue or 50% of the dose expected from the admmistration.
l Dr. Williamson suggested that the Working Group completely revise the definition of medical l event to say it is "an administration of byproduct material in which a technical error on the part of the care giver or device malfunction results in a dose that . . ." Ms. Haney noted that the ' phrase " technical error" would need to be defined. Drs. Stitt and Wagner agreed that it would be f-5 f
~
difficult to define " technical error.". Dr. Siegel noted that even with the proposed definition, O patient intervention would need to be defined. Dr. Stitt concluded that the proposed final rule b was a definite improvement over the current requirements.-
- Mr. Swanson requested that the Statements of Consideration contain a clear statement that subcutaneous infiltration of a dose that was put into a vein is not considered wrong route of '
adminictration.- l Ms. Haney requested comments on the phrase "or is expected to result." She explained that the
- Working Group used the abnormal occurrence reporting policy, which used similar languageiin developing the rule text. Mr. Graham and Dr. Siegel suggested using the phrase "results or will result" rather than the phrase "or is expected to result." Dr. Stitt agreed with this approach.
Dr. Wagner noted that the phrase " dose to the skin" could mean dose to a point on the skin or dose to all or a large area of the skin as an organ. He moved that all references to " skin, organ, or
' tissue" be revised to reference " tissue" only.'
. Motion 8: In f 35.3045, references to " skin, organ, or tissue" should be revised to reference
" tissue" only. _
Vote: 7 in favor, none opposed. O The Committee agreed, by consensus, to accept the remainder of the editorial rule changes to this section.
' Mr. Swanson moved that the Committee go on record as opposing the patient notification requirements in il 35.3045 and 35.3047. Dr. Stitt agreed with the statement that the ACMUI does not support any regulation for required notification of physicians and patients, because the requirement is redundant to existing State laws and medical ethics. Ms. Hobson also noted the possible cruelty in notifying patients unnecessarily and frightening them if negative effects of the event were not anticipated. Ms. Haney noted that the Commission believes the requirement to notify patients recognizes the right ofindividuals to know information about themselves and
-- provides the vyyuduaity for patients to consult with their personal physicians to make timely 1 decisions about their health care. Drs. Stitt and Siegel noted that providing the patient with a copy of the official letter citing Federal regulations hanns the physician-patient relationship. Mr.
Graham moved to modify the motion to add that notification is redundant to existing State laws and medicalethics. L Motion 9: ACMUI reaffirms that it does not support any regulation requiring notification of physicians and patients as this is redundant to existing State laws and medical ethics. i L Vote: 6 in favor, none opposed, I abstention. Ms. McBurney abstained, on the grounds that 1 NRC's reasons for retention of the requirement may be valid, and because she was not an official , i r
- 1 l
q ' Committee mepiber during the initial discussion. IV) Dr. Siegel proposed adding the words "if any" to paragraphs (d)(1)(v), (vi) and (vii). Dr. Stitt agreed, since in some cases there will be no effect on the patient; no improvements are necessary in the program; and no actions need to be taken. The Committee approved the change. Section 35.3047, Report of a dose to an embryo / fetus or a nursing child. ) i Ms. Flack indicated that the Working Group had not made any changes to the draft final rule since the subcommittee meetings. However, it has been considering whether the requirement , should be removed from the Pan 35 rulemaking and instead become the subject of a Pan 20 ' ! miemaking that would apply to all NRC licensees. She also indicated that the majority of the !
, Working Group members believed that the reporting threshold for repons should be 50 mSv
]
(5 rem) rather than 5 mSv (500 mrem). Ms. Flack noted that based on information contained in a recent study (Joy R. Russell, et al.," Radiation absorbed dose to the embryo / fetus from radiopharmaceuticals," Heahh Physics Journal, 73:5 (November 1997) pp. 756-769), a 5 mSv (500 mrem) level could result in a large number of repons being submitted to NRC. Dr. Siegel l noted'that if the Agreement States adopted the rule, the number of repons would be substantially ; larger because of gallium and thallium use. Ms. Haney noted that representatives from the I CRCPD SR-6 Committee indicated to her that they preferred the 5 mSv (500 mrem) level. Ms. McBumey moved that the requirement be placed in Pan 20. V - _ Motion 10: The reponing requirements for unintended exposures to an embryo / fetus or nursing child that are currently in f 35.3N7 should be moved to Pan 20. Vote: 7 in favor, none opposed. Dr. Siegel stated that the 5 mSv (500 mrem) limit could impact use of byproduct material in diagnostic nuclear medicine. He indicated that a number of nuclear medicine procedures could approach the 5 mSv (500 mrem) limit and would impose either a de facto pmgnancy testing requirement or a de facto diversion of women of childbearing age away from needed nuclear medicine procedures. Dr. Wagner stressed the imponance of the issue, arguing that the 5 mSv (500 mrem) level would lead to a great amount of patient anxiety and stress. He agreed that the rule would require pregnancy testing for a large number of diagnostic nuclear medicine patients. He supponed the 50 mSv (5 rem) reponing level. Mr. Graham moved that the ACMUI endorse the subcommittee recommendation that the reporting threshold be 50 mSv (5 rem). Motion 11: The reporting threshold in f 35.3047 should be 50 mSv (5 rem). Vote: 7 in favor, none opposed. Dr. Wagner noted that the only action a physician can do to protect the nursing child is to O
p properly notify and instruct the mother about the precautions to be taken to minimize exposure to the child. He moved that the notification requirements in f 35.3047. tbt pertain to a nursing child,- be restricted to events in which the mother was not properly instructed in accordance with 6 35.75 prior to release from the facility. Motion 12: The reponing requirements in 6 35.3047 should be limited to only those events where the mother was not properly instructed in accordance with 6 35.75 prior to release from the
' facility.
Vote: 6 in favor, none opposed, I abstention. Ms. McBurney abstained, on the grounds that NRC's reasons for retention of the requirement may be valid, and because she was not an official Committee member during the initial discussion. (Mr. Graham no longer present.) Dr. Siegel proposed adding the words "if any" to paragraphs (d)(1)(v) and (vi). The Committee agmed. ' t Mr. Swanson moved that the ACMUI state that it does not support any regulation requiring notification of physicians, mothers, or pregnant women as this is redundant to existing State laws and medical ethics. Motion 13: ACMUI does not support any regulation requiring notification of physicians, mothers, or pregnant women as this -is redundant to existing State laws and medical ethics. (/ Vote: 5 in favor, none opposed, I abstention. Ms. McBumey abstained, because NRC's reasons for the requirement may be valid. (Mr. Graham no longer present.) Dr. Siegel suggested and Dr. Wagner moved that the langunge on unintended permanent functional damage be added. Motion 14: The following phrase should be included with regards to the embryo / fetal reporting
'. requirement in i 35.3047(a): "Has resulted or will msult in an unintended permanent functional
. damage to an organ or a physiological system, as determined by a physician."
-Vote: 6 in favor, none opposed (Mr. Graham no longer present).
Dr. Siegel raised the question of how the phrase "specifically approved in advance by the authorized user" will be interpreted, when a dose is given to a patient based on the belief that she
..is not pmgnant, especially during the period when pregnancy is undetectable. Ms. Haney .
requested advice on what the Statements of Consideration should say on this subject. _ Dr. . Wagner noted that if the threshold is placed at 500 millirem, a large number of reports would be generated concerning doses to individuals within the first two weeks after conception. Dr. Williamson expressed concern that the medical community will be forced to give pregnancy tests
- to every woman of childbearing age who receives a diagnostic procedure. Dr. Wagner noted that O
tb ]- p even pregnancy tests would not be effective early in the pregnancy. The Committee concluded ( . that the Statements of Consideration should acknowledge that there is no need to report an exposure to an embryo / fetus if the exposure occurred while the pregnancy was not rnedically detectable. The meeting recessed at 5:33 p.m. on March 24,1999.
- The meeting reconvened at 8:08 a.m. 'on March 25,1999.
REVIEW OF ISSUES RAISED BY NRC GENERIC ASSESSMENT PANEL Dr. Bob Ayres explained that the NRC Generic Assessment Panel had two issues requiring ACMUI advice. First, an Agreement State licensee had used an uttasound device to place iodine-125 (I-125) seeds in a patient's prostate. The ultrasound device did not have the necessary
~
resolution to image the ends of the implant needle. As a result,31 seeds were placed in the patient's bladder. Dr. Williamson suggested that the problem was a failure of the device quality assurance program, noting that there are standard tests that are done to ensure contrast resolution. Dr. Holder thought the problem was due to inadequate operator training. Speci5cally, operators
~s hould know what they are looking at and be obligated to not proceed if they cannot see properly.
- Dr. Siegel asked if this event was considered to be a misadministration or an example of malpractice. If a physician perfonned the actions, he suggested, it might be malpracuee and not
, require NRC involvement. Dr. Ayres said it was a mi# ministration, since the intended dose .
i was not given. He asked ACMUI to advise whether NRC should describe this event to its licensees as a generic issue. Ms. McBurney did 'not believe it was a generic issue since this was the only instance known to have occurred. Dr. Cerqueira thought that it was a malpractice issue ,
'and no NRC action was needed. Dr. Stitt indicated that the staff needed to provide additional, more detailed information to the ACMUI prior to any further action.
Second, an Agreement State licensee was giving written instructions to I-125 prostate implant patients that directed the patients to strain their urine for at least the first few days, after source implantation, to capture any I-125 seeds. The instmetions directed the patient to return the seeds to the hospital. The licensee indicated that the purpose of the instructions was to ensure that the patient is receiving the " correct dose." Dr. Ayres indicated that the Generic Assessment Panel was concerned that patients would not handle the seeds properly. He' requested ACMUI advice on actions, if any, that should be taken by NRC. Dr. Williamson thought that it could be within the medical purview of the physician to ask that the seeds be counted, but he believed the patient should be instructed to then flush them down the toilet rather than collecting and retaining them or transferring them to someone else. Dr. Nelp thought the instruction given to the patient was a matter of med'eal practice and ACMUI or NRC involvement was not needed. No further recommendations were made. fA./ I
'.i
e
\
7J_ j l l-
' CONTINUED REVIEW OF KEY ISSUES IN WORKING GROUP'S DRAFT FINAL PART 35 RULE i
Section 35.2, Definitions. '
~
Ms. Rothschild questioned whether the duties of the AU,' ANP, AMP, and RSO should be placed
- in the rule or in the guidance document. The Committee agreed that the list of duties should be placed in the guidance rather than in the rule, provided the list did not place any additional l
. requirements on the individuals.
' The Committee agreed with the following actions:
1.~ : The definition of diagnostic clinical procedures manual and reference to it should be - deleted from the rule. J l
- 2. ' MDR remote afterloaders should be defined.
1 i
- 3. . The definition of prescribed dosage should be revi xi to stater"the quantity or range of radiopharmaceutical activity, as documented in . . . I e 4.- Ms. Haney and Drs. Stitt and Williamson should develop a definition of manual l
- 5. The term " radioactive drug" rather than "radiopharmaceutical" should be used generically -
ir die rule. They noted some places where it may be necessary to use the phrase i
" radioactive drug contain'mg byproduct material." !
- 6. : The definition for a unit dosage should be revised to reference dosages pisy-od "by or under the supervision" of an ANP or AU. The definition should also clearly state that a unit dosage is a dosage intended for medical use, without subsequent manipulation, in a single patient."
i Section 35.12, Application for license, amendment, or renewal. The Committee was asked whether NRC should only review and approve the procedures ! required in Subpart H as part of the license or amendment process. Mr. Swanson and Dr. Siegel , 1 noted that Subpart K should r: quire a more detailed review of procedures for an emerging
- cchnology. . Dr. Williamson supported the change, but asked why it was necessary for NRC to review the ymced cs required by Subpart H. Ms. Haney explained that at present only one ;
procedure is reqmred by Subpart H (full calibrations and spot checks). i 4 16-
, l l
o p .
\ Drs. Wagner and Williamson suggested that the review of procedures was unnecessarily burdensome and resulted in a situation where the licensee could only change a protocol by a license amendment. Ms. McBurney noted that Agreement States prefer the review to be done by
' the license reviever rather than by an inspector.
Dr. Cerqueira moved that NRC should not require license applicants to provide any procedures, including Subpart H procedures, to NRC for review prior to NRC issuance of the license or-amendment and, therefore, should not tie licensees to those procedures via license conditions. ' Dr. Wagner noted that the real issue was whether licensees must follow the procedures unless they apply for and receive a license amendment that allows use of a revised procedure. He suggested the motion should say that the licensee is free to amend the procedures as needed,
-without prior approval.'
Motion 15: ACMUI believes that NRC shoul'd not require license applicants to provide any
' procedures (including Subpart H procedures) to NRC for review prior to NRC issuance of the L ~ license (or r.mendments)'and therefore should not tie licensees to these procedures via license L conditions.
Vote: 5 in favor; I opposed,1 abstention. Ms. McBurney opposed because States and many licensees want review of procedures. Dr. Nelp abstained because he disliked how the motion was phrased. . b L h Section 35.60, Possession, use and calibration ofinstruments to measme the activity of unsealed byproduct materials. l
- The Committee agreed with the proposed revisions to 6 35.60. Mr. Swanson recommended that the identity and serial number of any radionuclide standards used in calibrating the instnunents j be included in the recordkeeping requirement in 6 35.2060. !
Section 35.63, Determination of desac e of unsealed byproduct material for medical use. Dr. Siegel noted that i 35.63 needed to be revised to address the issue of tritiated and carbon-14 compounds used in research, which may be obtained from a manufacturer who is not a i 32.72 ! licensee, radiopharmacist, or AU, but whose activity cannot be duectly measured by a licensee i without altering the dosage. Dr. Stitt suggested additional work by the Working Group to ; address the issue. ' Section 35A00, Use of sealed sour,ces for manual brachytherapy. The Committee agreed'with the addition of the phrase "in accordance with an effective
. investigational device exemption application accepted by the FDA"in 6 35.400. The ACMUI :
believed this phrase addresses use of sources not listed in the Scaled Source and Device Registry. J l
l Section 35. 410, Safety Instructions. The Committee agreed with the revision to f 35.410 that requires an AU to be notified if a r
. patient or human research subject has a medical emergency or dies.
j Section 35.432, Calibration ====wements of brachytherapy sealed sources.
. The Committee agreed with allowing a licensee to accept a manufacturer's calibration of manual brachytherapy sources.
Subpart H, Use of a Sealed Source in Remote Afterloader Units, Telctherapy Units, and Gamma Stereotactic Radiosurgery Units. - The Comn$ittee agreed with limiting Subpart H to photon-emitting devices. Section 35.600, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic' radiosurgery unit.
.. l The Committee agreed with the addition of the phrase "in accordance with an effective investigational device exemption application accepted by the FDA" in i 35.600. The ACMUI
{ believed this phrase addresses use of sources not listed in the Scaled Source and Device Registry. ' j ( Section 35.615, Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. i j l 1 Dr. Williamson noted that the requirements for qualified individuals to be present duriug initiation and ongoing treatments with MDR and HDR afterloaders should not be identical. He believed that requirements for MDR, L.DR, and PDR remote afterloaders should be similar.
- i The Canmittee reached agreement on the following items:
1.' The draft final language in i 35315 for "an authorized medical physicist and an authorized user or an~ individual under the supervision of the authorized user who has been trained to remove the applicators in the event of an emergency, to be immediately available during continuation of all patient treatments," during initiation and ongoing treatments with an MDR afterloader provides needed flexibility. ! I
- 2. ~ Only a physician designee is needed at the initiation of a treatment with a PDR remote !
afterloader.- I
- 3. Paragraph (b) should be revised to delete the requirement to "immediately" shield the i radioactive source for gamma stereotactic radiosurgery, because time is needed to withdraw the patient.
i
i 1 l 4 Section 35.632, Full calibration maa=uregnents on teletherapy units. [ Section 36.633, Full calibration measurements on remote afterloader units. Section 35.635, Full calibration measurements on gamma stereotactic radiosurgery units. l The Committee agreed with the requirements for calibration in 6f 35.632,35.633, and 35.635. l Section 35.642, Periodic spot-checks for teletherapy units. .I o ! Section 35.643, Periodic spot-chacks for remote afterloader units. Section 35.644, Periodic spot-checks for low dose-rate remote afterloaders. Section 35.645, Periodic spot-checks for gamma stereotactic radiosurgery units. i The Committee agreed with the removal of the redundancies in if 35.642,35.643,35.644, and 35.645. Dr. Williamson recommended changing the check on source transfer tubes from quarterly to annually. He also recommended NRC clarify whether LDR remote afterloader j licensees need to possess a calibration system if they rely on the manufacturer's calibrations. Section 35.657, Therapy-r*Intad radiosurgery units. The Committee suggested that Dr. Williamson review the requirements in f 35.657 duectly with the Working Group. Preparation of Commiazion Briefing Materials l The Committee members developed a list ofissues that they wished to bring to the attention of the Commission and identified the members of the Committee who would present particular ' parts of the briefing. i 10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Cedain Items !
- Containing Byproduct Matedal Mr. Swanson noted that Part 32 contains similar requirements to the current Part 35. In particular, f 32.72, " Manufacture, preparation, or transfer for commercial distribution of
- radioactive drugs containing byproduct material for medical use under part 35," requires that the
- licensee have instrumentation to measure the radioactivity of drugs and have procedures for use
. of the instrumentation. Mr. Swanson made a motion that, following completion of the Part 35 rnimaking, the NRC review i 32.72 and make it consistent with the requirements in the final
. Part 35.
Motion 16 Subsequent to publication of the final Part 35 rule, NRC should review Part 32 for items of consistency. Vote: 6in favor, none opposed. p l g - ACGME and NRC Approval of Training Programs
\
'Dr. Cerqueira indicated that only the nuclear medicine program, as described in the ACGME Directory, meets the requirements to be ACGME accredited. The description of the radiology program is general; the cardiology program does not specify details about the hours of training; and the endocrinology program does not specify requirements.
l Dr. Cerqueira was concemed that all cardiology, radiolog' y, and endocrmology programs will have to apply to NRC for approval. He noted that there are over 400 cardiology training programs. He was uncertain how quickly programs could make the necessary changes to the ACGME Directory. Dr. Holder suggested that all of the 400 programs would not involve nuclear l cardiology and so only a portion of them would seek approval. Dr. Siegel argued that programs,
- l. such as radiology, would be able to make the necessary changes in the program description
- within the two-year rule implementation period.
Mr. Swanson suggested that the cardiology and endocrinology societies should seek information on what would be involved in obtaining ACGME approval of the nuclear cardiology and nuclear endocrinology programs. Dr. Siegel noted that programs have cross-departmental training, so potentially cardiologists or endocrinologists could obtain the necessary training as part of a radiology or nuclear medicine program, as an elective in their cardiology or endocrinology training. The necessary training could be an elective component of an ACGME-approved training program, rather than an essential component of all programs, but the requirements of the program _O would need to be specified for that elective.
'\
At 12:17 p.m. Ms. Haney adjourned the meeting. ; i f l N4 ( .
p % i
SUMMARY
OFMOTIONS l O- - Motion 1.1: I. eave i 35.392(c)(1) and (c)(2), with respect to the required hours, unchanged.
;Ygsg:_ 7 in favor, none opposed.
Motion 1.2:' [ 1. Section 35.292(c), introductory sentence - The phrase "in basic radionuclide handling ! techniques" should be' deleted and the term " radioactive drugs" should be substituted for i the term " unsealed byproduct material." L 2.~ Section 35.292(c)(2) - The word " direction" should be substituted for the word
" supervision" and the term " authorized user" be replaced with the term " preceptor
! - authorized user." , 3. Section 35.292(c)(3) - The phrase "an authorized user" should be replaced with the l phrase " preceptor authorized user" and the word " physician" should be deleted. Xgte:' 7 in favor, none opposed. Motion 2: Modify i 35.300(b) to state "who meets the requirements specified in (( 35.292, 35.390, or an individual under the supervision . . . " y_ qts: 7 in favor, none opposed. Motion 3: Table the motion to discuss intravascular brachytherapy for prevention'of restenosis in the vascular system until discussion of Subpart K. ! ,O y_gla: . 6 in favor, Dr. Cerquiera opposed, believing it appropriate to discuss at this time. 1 U Motion 4: Approve the training and experience requirements - altemative pathway (chart) y_ gig: 7 in favor, none opposed. . Motion 5.1: That i 35.24(b) be amended to state " Subparts E, F, and H or two or more types of units under Subpart H."
- y.gie: 7 in favor, none opposed.
' Motion 5.2: That i 35.24 be amended to " establish a radiation safety committee to oversee all uses of byproduct material permined by the licensee."
' y_gts: 7 in favor, none opposed.
Motion 6: NRC regulations should reflect the following:
- 1. An authorized user may prescribe a dosage range for material admmistered under il 35.100,35.200, and 35.500.
- 2. An authorized user may not prescribe a dosage range for material administered under j (( 35.300,35.400, and 35.600.
l~ 3. Admmistered activities can deviate from a prescribed dosage by 20% !. . y_p.ts: Motion withdrawn. t
U L i-
' ~
Y - Motion 7: Amend i 35.63(d) to state that unless otherwise directed by the AU, a licensee shall l, k not use a dosage if (a) the'dossge differs from the prescribed dosage by more than 20% or (b) the dosage does not fall within the prescribed dosage range. [ .Vgg: 7 in favor, none opposed. Motion 8: In f 35.3045, references to " skin, organ, or tissue" should be revised to reference
" tissue" only.
! s p Ygn: 7 in favor, none opposed. [ Motion 9: ' ACMUI reaffirms that it does not support any regulation requiring notification of .! physicians and patients as this is redundant to existing State laws and medical ethics. l
. Ygn:- 6 in favor, None opposed, I abstention. Ms. McBurney abstained, on the grounds i that NRC's reasons for retention of the requirement may be valid, and because she was not an official Committee member during the initial discussion. '
Motion 11: The reporting threshold in f 35.3047 should be 5 rem.
' Ygn: 7 in favor, none opposed.
g Motion 12i The reporting requirements in i 35.3047 should be limited to only those events where the mother was not prcperly instructed in accordance with 6 35.75 prior to release from j
. the facility.. '
y_9.ts 6 in favor, none opposed, I abstention. Ms. McBurney abstamed, on the grounds O that NRC's reasons for retention of the requirement may be valid, and because she was not an official Committee member during the initial discussion. (Mr. Graham no longer ; present.). Motion 13: ACMUI does not support any regulation requiring notification of physicians, I mothers or pregnant women as this is redundant to existing State laws and medical ethics. ygn: 5 in favor, none opposed, I abstention. Ms. McBumey abstained, because NRC's reasons for the requirement may be valid. (Mr. Graham no longer present.)
. Motion 14: The following sentence should be included with regards to the embryo / fetal ;
( reporting requirement in f 35.3047(a), "Has resulted or will result in an unintended permanent i feianni damage to an organ or a physiological system,~as determined by a physician." Ygn: 6 in favor, none vypesed (Mr. Graham no longer present). 22-
,1
.') ,1 ' L '
L. Mofon 15: ACMUI believes that NRC should not require license applicants to provide any procedures (including Subpart H procedures) to NRC for review prior to NRC issuance of the v license (or amendments) and therefore should not tie licensees to these procedures via license conditions.- Xgn:, 5 in favor; I opposed, I abstention. Ms. McBurney opposed because States and
~
many licensees want review of procedures. Dr. Nelp abstained because he disliked how the motion was phrased.- Motion 16: Subsequent to publication of the final Part 35 rule, NRC should review Part 32 for items of consistency. Ysts: 7 in favor, none opposed. t
.e 8 e
l l
/
\v' ,
s e s a c 5 t i s , m m m m r s a a a a t a m a r y r x x x x ,ce x ,ce i ht e e r, e r, e r
, e mn r, a e d
P o emn r,a e r y 2 S O o o o orige r origer t p t p t p t pop t s t pop I M e e e e r cpx e i e r c e c c t n c px m m m C p r e r p r p e reel D e reel ea a x a x a x pM ca R , , , , , pM c e e e N n n n nGi n n nGin r, r r y i a i a i a a iCi l i a a iCl i t o t o o c c c c c c p p t p b i s i s i s iAc s i iAc e e e d y y y yr r s s y s yr r s c c c e h h h h yy h h yy e r r U. e r e r . v P P P PI 2 P PI 2 P oA P P o r spp ) s t m r nA e a r h ( g 8mdr 9ea o r l a c 0 2 0 4 4 0 0 0 0 0 9 io r P i t 5 5 1 t q uB l a c a y n r 1 uRseb g i t o P n a 0 t n Aci ueo t c u 0 7 3 na Oh - d ) s m eiirf ec E h r l d ( c u ei t e . t a Rxper r u i t c 0 4 0 8 0 8 0 0 8 0 0 0 0 t A dEe C t u c c a 2 2 2 sdo on s t S t r d i D pat ogn in e Pim n ie ar ri Tuq n o d e n e R i t e i o i r r t a u e c x z q i v e i l e r t a , a e s s n c i e m o o i v s o i c e l i t d t c n v l t u n e y g e A l i a i r p i a d d g d a d l a n r c e n e r k i g t e ht f o i d t a a i t y s e p m r h e m u i w c c c
- - - a r
r u i t d d d b o u e e e l s e l a l a l a a d p e e e u e a r s s s n l a e n n n a c h U , U , U , M , S T, 0 0 0 0 0 0 0 0 0 0 0 0 P 1 2 3 4 5 6 O P 5 5 5 5 5 5 S M N 3 3 3 3 3 3 R A A a
r J e n% i d n u U A n A n. i a t ic tn n s e e l y a h m m c p n n it c o o r a a ir r e y v i v p n b a
- t s e n e d e
s t s w n l a la i u e ic v m h t m in ic n r e e p m 0 a r lc i l c d u a 9 P r 6 i u a ae sd g q y y y d 5t.n n ns t nste y o e v R e r o r to i e r o ieu e ae r o e c e s r p e y uq 3, 0 m t t a a c a cq t a n u l i rl rl r e a t a oa b c oa ne b ci oa ne rl b ciyer to e r r o i r f o n 9 e a y b e e io 4 a t n l ait c laic r t e l airt d ac er r bo go r m a a m a p x p ta 5t s r po l r d ar d ar px x g r r e ty c 3 e t anp npe a npe a te a l, ae t g o r d n a g o d r o d u 2,ot r l A md e mdd e e mdd ee c mc a p m r p ice t c is f r d e 9 p 3 e osi oiis s oii s se oe a rv l cab o cab l e e 5 ec
- ov r r s e mv s ee r rv ovv r r rs u s
osu r s it c ciM o r icM t ci d i p e s u e c n r u 3, rp S s ap s pp a s a pp eeh sh a tcG s s a acG t ds su d e t c a c 0 au x 9 a d i r aC a e u c u u d cs u i rC i T l l s s r l a l r r z r lcs s e c e d pA c ua e tr d pA s 3 ve i s s N r r uu s r r r uu u s s s s s r r r uuu e s s r s u e s r sr s r s r s rs s r r N I h oe2 r yNh o p x s r 5 a E oo ooo oooa s oas uu ooea u uua e u 3h o ooe O 010 Ou t s o 2M hh 00 hhh 000 hhh c 0003 h c 03 hh y 003 h 8 hh y 003 n2 r I T A S ye r a h 2,os 9l t E 42 848 848 8 00 P 0 a nR 5 5 25 00 25 l O- O- M2 0 7 2. t 5 s eI 3, u mU - - - - - - - - - - - - - - - - - - - - - - - 0 m hQ O t t cE aR i s a m 9P
- 2. N 5 A 3
m l dn AE e v a g i - C i t c r a, deP d N e r n a, nM E i d ) I n 0 s t uA R e 0 4 0
) i n U ,
AU t E i t r 5 0 u 5 y nA
.P s a w 3 I 5 p a An X lie h
( s 3 r e .A E m l a e c 3 ( ht m. hic r s le D ts) nr i s7 ) e# t ir te w u o i s o e at s ri gr N iot d2 i a r o s n t, s ot ri a A te l.
- t. u t. m) 0 f y p ia g t i) n0 pd rJ c tsJ t c 0 1
a d u0 depo G x# e nJ o u3 3 1 r e r o r6 vr N I dl r itai lm3r 5 I e ht y f s e5 da 3 o o, r n r e N a, i e is ln i m p$ y - d d i h a c c r lo5 ( t pt pi s
.I A nu ioqr e v e h l io r u o f r
es t s i s c at n o r r d e b s a it n ic a S R t u t e l imto e ler a u eq i iu m la u d teu oy is m r
/e A d, T l i o s n le me r r
e y a r n d, ns a n g s nre d o a a c eg ic P h h P oa ei ni u s s m s r r f f i k a w igr e f i f o f o f o f u O l a r a Cic tpit ai ow ei e e e oso y ic e Es y _ uc r imtrr s t uce s u s u s u ei sd ua te d e lc u Nh r oi r r i r r r r r r r f a M N inp a oD o i f D f oi f d o o oc S d d gn gn gn f f f f i t n e e e e _ ine n e n e gd ne g n g n gc a o i z i z b b nt i t inir t t int t iniur i n i int i t a r o r o t s y r ii in in a o e i ht ht ua mm i r iaW iaW ia q a a r d T( r T( r aW r T( r Tre T r T r r e Tt s R a A u u A g0 n9
- - - i5 0 2 0 2 0 0 0 n
( 9 i5
) 2 9
2 9 3 9 3 9 4 9 5 9 6 0 1 5 5 a3 r 5 3 5 3 5 3 5 3 5 3 5 5 5 5 5 5 5 Ti 3 3 3 3 3 I 6 i 5 5 I I 6 9 i
- f "
s es a c 5 t i s , m m m m r m s r a a t r e a a a a y x x x x ,c e i x ,e ht O e r, e r, e r, emn r, a e d P o e mn r, a e c r y 2 S o o o orige r orige r M t t t t " p p p pop t t pop I ' e e e e r is , c c c c px e t e r c px e e e e El n e m m m i r r r e e r El a a a a ~' p p p a D x x x C , n, , pMc, , pM c e e e n n nGn i n nGn i r, r, r, R a a a aCl a o o o N i c ic i c i c iAc i i c i aCi c l t p t p t p m y i s y i s y i s yr r s s i s iAc s s e c e e b y y yr r c c r r U h h h h yy h h yy e e r er d P P P PI 2 P PI 2 P oA P P _ e v o r ) t s pp m s r a h nA e r g ( 8md l o a 0 0 0 0 0 r r c 0 0 9ea 2 4 4 P i t 5 5 9rio l c a 1 uB a n r
't q y o P seb uR i t
1 g a ueo n 0 t c 0 n Acina u 7 n e t d ) m - ec E s a m' h t t c a l eiirf u ei Rpr x e t d t e r u h i ( r c 0 4 0 8 0 0 0 8 0 0 0 0 A dEe C c u r t c a 8 2 2 2 sdo o n s t t S d i pat D ogn r n e Pim n ie ar ri Tuq e R e v n o d _ i n e t a i t e i o i r r c t a u m x z q . t e e, l i e r l a e s s - A n c o v i s e c o l it o i i t u d c n v e _ l n e r y g a d - i d a i p i s g d a r d l a a e n n e r c w k i g t e ht f o i d t a a i t y s e p r h e m u m w c c u i
- - a r c x.
r u i t d d d b o u e e e l s e p l a l a l a a d e e e u e a r s s s n l a e n n n a - U c h - U U M S T, u 0 0 0 0 0 0
, 0 0 0 0 0 0 P a
m 1 2 3 4 5 6 O P M N 0Q . 5 3 5 3 5 3 5 3 5 3 5 3 S R A A . m a a
- )
~ r e
d
"(\ V n u
U A n A n. i a _ t t ics n n i y - e e n h n m ie p _ m n t o r o r c a a i v i v r p e n b
- e n d
_ s _e e t s y t n l a l a is u e c v m a m ic n in r e w e i i p m 0 _ r l c l c d u a 9 h i u a sd r g 6 a te _ t y y a q n y d te y o 5t. ns 3, wn e r o r r ins e aeu r e e r P R ta t o a i e t o a eu y t o c r s u p e rl rl oa ne c rl c q r q a icr l a 0 n v oa b c b ci oaciine bait cr y t oer a r o e f o io n 9 e 4 t r y a i ai b p e t t c laic r t e c er r m a m p t 5 bo go t a l l a l a x a 3 ,rs d ar d ar px d ar po x g r
'd r e y c n n p npe npe ae g o n g d
t r u o r e a mde a mdd e e a mdd e e a tec l, ta mc r p a o r p ice t i s f o d e 2 9 tp t os m c rv r d 3 e l oiis s osi i s e oe caEl o cai l l a e e e 5 ce A ovi ov r r v ov v us os iMc o c d e s r ciM c i r t r rs r r r u it r t i p u u 3 r s s c s e s e s eeh s ct acG s a tcO d u n t c ,p a r a pp a ppc sh d a s a d a s s d e ie u 0 a S lc u s l c u s s u l t s u u a s e la a c c e i pA d rC l c i d pA rC r u r a z r e t r 9 T s s s s s s s s s s I oe2 r i p s 3 ev s s s s s s yNh o r r r s s x s N uu n r r e e e e r r r r r ruar N h 5 a E oo uwn o e u mnums u a ms u ac uu ooe a
'u o u ooe O0 0I Ot u e
s r u o 3, h hh ht h kl c hh y h r i l hh y I rA I a h 2 os 2M 00 42 0t 84 R h 1 t on43 M aM O3 M 003 00 8 003 00 T 2 l' l' S ye 0 9l tE $ s 25 O- O- M2 0 2 a nR eI 25 7 5 t s u l/ mU . - - - - - - - - - - - - - - - - - - - - 3, 0 m hQ 9 f \ N. cE aR a 2. 5 3 P N A
- t t
s i m AE e m ld _ a in a C e n g r N e t d n d e P, E d t i a, nM _ I R n 0
)
0
) i ts U
uA , E - te t 4 6 0 n u AU P i r 5 3 5 y nA X s a w
$ 5 p a An E ie h
( s 3 r e .A D d u l a ic h' e c ( ht e m. a s t _ N t s) s) ir e w r u os is s o l e ii gr A n0 io0 i0 d e0 ta r o n t, s et a 1 u 2 mlr y' g r G t e r5 t s 5 i f 1 p i a i t ) n0 pdi N I c3 x n 3 t i ct hi3 3 1 a e r d r u06 r depo N e$ ioi- - ht o e5 v r I d tad m5 r3 I e y f s da 3 o o, A nde z r p5 d h c e lo1 r pt a, i r li r y i c ( t pi s R nu ai c r h d
- d o
a r r u r es t ic s at a itn t T ioqe oq d er i b o f s a n l e le ie m l s eu ic S e t u r r a d is m A/ d, d a equ u toy r l i o t n a o t n s iu d n a le a me r r e h y h a r n d, n gs n r o o c eg ic P P oa ei s ni u s s m s r r f f i k a e igev f i oev f o f o f o f us o O l a r a e Cic t v ai e o y ic Es y pi t uc mtc ei s t s e s es ei sd t e d e lcu Nh p r e ir er uc e u u u uar f n oi r r r r r r a M N i a i oi r o o f D f oD fd f f f o f oc i S d e d e ee gn gn gn g g gc a t n z b b n te n te ne gd n . o i izr int int t ine r i into i t a r o o t s y i ini t ini n i n ne ua a u i ht ht i ia 1r Wo ia 1 r Wr ia Wu 1 r 1 r q e ia 1r iar ia e 1r t r d a u u mm I
* ( I
" ( 'I ( I
~ r 1 T *I s R A A g0 n9
- - - - - - - - - i5 0 2 0 2 0 0 0 n i5
)- 9 9 9 9 9 9 9 5 a3 2 2 3 3 4 5 6 0 1 5 r 5
3 5 3 5 3 5 5 5 5 5 5 5 5 5 T5 3 3 ( ( I 6 i 5 i 3 B 3 I 3 6 3 6 3 5 *
- vordan, Atuut j UNITED ST ATES MorriSon, RES l
- . . ;;[, ..,%*,$ '
NUCLEAR REGULATORY COMMISSION C 1 j y W ASH W G TON,0.C. 20555 1_ h an { t
- Thompson August 21, 1906 Blaha
%, * . . . * /
OFFCE OF THE SECRETARY MEMORANDUM TO: James L. h11hoan co-chairperson, Strategic Assessment and Rebaselining Steering Committee James W. Johnson < Co-chairperson, Strategic Assessment and ) Rebaselining Steering Committee James M. Taylor i Executive Director for Operations ! I John T. Larkins e utive Director /ACRS/ACNW ) FROM: ohn NKoyle, [xt- Secretary l
SUBJECT:
STAFF REQUIREMENTS - COMSECY-96-028 - STRATEGIC ASSESSMENT ISSUE PAPER: INDEPENDENT OVERSIGHT (DSI 19) m m i this issue is direction
\m
)TheCommissiondoesnotbelieve-
/ setting and believes that. it sht not be included in the set of issue papers for public comment. a addition to the Strategic l Assessment and Rebaselining Steering Committee, the Advisory l Committee on Reactor Safeguards, Advisory Committee on Nuclear l Waste, and the EDO are requested to respond to the actions described below. Furthermore, this issue paper should be given normal distribution associated with SECY papers. The issue paper does not require revision prior to release.
The Commission continues to believe that independ technical oversight is essential in order to ensure that F products are a decisions of the highest technical quality and the Commiss: have the public's confidence. But considering ti changing environment, the reduction of workloads in a number of areas under the purview of several of the referenced independent l oversight committees, the d" plication of the activities between committees in some areas, 5.'.d 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, Periodic Review of Committee Charters) and 1 (Establish Criteria to Articulate the Threshold for the Need and Type of Independent Technical Oversight) as summarized below: n _4s m-j l. (Modified Option 2) The ACRS should remain as the nttachment 1 M usi3uu M hp.
r- . 2-
'{
/' ~i, 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 enarter 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 programs, the Commission continues to believe that issues presently being addressed by the ACNW will continue to exist in one form or another; therefore, the Commission believes that some form of independent technical oversight Fhould be retained f r the areas under the purview of the ALNW. .he 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 also preserves the option of having an active body of expertise available j should the activities under the purview of both the ACRS and the ACNW increase in the future. r~'s\ (ACRS/ACNW) (SECY Suspense: 1/2/97) i
\_ I 2.
t 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. l (GGG/ACMUI) (SECY Suspense: 180 days after final NMSS Commission decision on medical program) 9600117
- 3. (Modified Option 1) The Commission believes that the l activities of the NSRRC should be revisited. This committee played an important role ir its first few years of existence in ensuring the effectiveness of the research program in addressing the evolving regulatory needs.
(EOG/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.
(GOG/CRGR) (SECY Suspense: 11/29/96) 9600119 AE0D
- In general, for the independent oversight committees that remain,
! as well as the CRGR, the Commission supports Option 2 but ! /'~S believes that the periodic reviews should not be limited to only f 'i'- ') the committee charters. Each committee should be eva?uated to determine what value it is contributing to achieving the agency's [
~ !~, p _ , . e
+' :.
*A 3
.w mission, but the committee should also be directly involved in f .this' evaluation ~. That.is, each' committee is requested to produce a set of criteria, for commission consideration, under which the performance of L the committee would be evaluated in the fu';ure.
/Each committee should then periodically review itself against
~
.these criteria and provide the results of-this evaluation'to the
. Commission.
(ACRS/ACNW) (SECY Suspense: 1/2/97) 9600120 RES (EDO/NSRRC) (SECY Suspense: 6/30/97) 9600121 AEOD (EBO/CRGR)' (SECY Suspense: 11/29/96) (SECY Suspense: One year after 9600122 NMSS (BBO/ACMUI) final decision on medical program)
~
cc: Chairman Jackson Commissioner Rogers _s Commissioner Dieus K. . Cyr (OGC) { .D. Rathbun (OCA)
'V H.' Bell (OIG) e
~
fe .
,4 ,
[ ". . UNITED STATES [ j NUCLEAR REGULATORY COMMIS810N wasmworon. o.c. menen . e.... April 9,'1998 d MEMORANDUM TO: Chairman Jackson Commissioner D6cus Commissioner Diaz Commissioner McGaffigan FROM: L Joseph Callan Executive Director ations 6UBJECT: STAFF REQUIREMENTS MEMORANDUM DATED AUGUST 21, 1997, COMSECY-96-028, ' STRATEGIC ASSESSMENT ISSUE PAPER: INDEPENDENT OVERSIGHT (DSI 19)* The Commis6 ion,in a Staff Requirements Memorandum dated August 21,1996. COMSECY-96028, ' Strategic Assessment issue Paper: Independent Oversight (DSI 19),* discussed its continuing belief in the value, to the Commission, of independent technical oversight committees to the Commission in order to ensure that Nuclear Regulatory Commission's (NRC) products are of the highest technical quality and that the Comrnission's decisions have the public's conndence. Furthermore, the Commission stated that each committee should be evaluated to
, determ4to what value the commsttee is contributing to achieving the Agency's mission, and that
( the committee should also be directly involved in the evaluation The Commission requested that each of the independent oversight committees produce a set of criteria, for Commission consideration, under which the performance of the committee should be evaluated in the future. The staN discussed COMSECY 96 028, as it relates to the Advisory Committee en the Medical Usse of lectopes (ACMUI), with the ACMUI members during the ACMUI meetino het on . March 12,1998. The ACMUI members, in conjunction with the staff, developed the self- . evaluellon criterte outilned in the attachment , for Commission consideration. The staff considers the criteria sufficiently comprehenseve to adequately assess the ACMUI's value to the Commission. The ACMUI wE perloeceny review itself against these criteria and provide the results of this evaluellon to the Commission during its antwM meeting with the Commission, commencing with Wie 1900 annual meeting. Typicany, the annual brienng is scheduled during the second quarter i of Wie calender year. The staN wE independently condud an annual evaluation of the ACMUI, using the attached crterle, and wE provide the results of this evaLetion, in writing, to the Commission during the second quarter of the flecal year, sT.T Mag with the second quarter of calendar year 1999.
, , l
- 23 gg my gFwm e.nov go Attachment 2 3
$00 3 qCl UISO ?ff-
2 , . ,f ' The stars evaluation will include.an observation concoming N the ACMUI is e#ective in pmposin0 sciutions to problems as opposed to simply raising new, unresolved questions. Attachr'wt sew 4 valuation Criteria forthe ACMUI CONTACT: PatriciaVacherton,NMSSAMNS
-{301}415 4376 cc: SECY.
OPA ' OIP . OCA J i
~ OlO
. OGC l CFO CIO l
e 4 i
L' t . L* ,U SELF-EVALUATION CRITERIA FOR TIE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES (ACUMI) l 1. Does the staff and the ACMUlinteract in such a manner ss to satisfactorily address L issues before the Committee? l '
- 2. Do the Committee members clearty define issues for staff and provide timely, useful l
information to the staff when requested? l 3. Does the Committee provide critical review and oversight of issues? i ! 4. Does the Committee provide expertise / advice which is not available from within the agency? l l
- 5. Does the Committee meet frequently enough to address issues in a timely manner? Are l any changes needed to the mesJng frequency?
- 6. Do committee members bring issues from the medical community to the attention of NRC staff?
l 7. Does the committee facilitateMoster communication between the public/ medical community and NRC7 l l 1 Attachment b
;}}