ML20149E697

Summary of 940519-20 Meeting of Advisory Committee on Medical Uses of Isotopes in Bethesda,Md

ML20149E697
Person / Time
Issue date:	06/24/1994
From:	Siegel B NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI)
To:	Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20071N673	List: ML20149E697
References
FRN-60FR4873 AF-10-1-7, AF10-1-007, AF10-1-7, NACMUI, NUDOCS 9407150127
Download: ML20149E697 (23)

Text

__ _ __ . .__ _ __ _ _

MEMORANDUM FOR: Carl J. Paperiello, Director Division of Industrial and Medical Naclear Safety, NMSS FROM: Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes

SUMMARY

REPORT - MEETING OF THE ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES, MAY 19 AND 20, 1994 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held its semiannual meeting on May 19 and 20, 1994, at the Holiday Inn, Bethesda, 8120 Wisconsin Avenue, Bethesda, Maryland.

Committee members present at the meeting were:

Barry A. Siegel, M.D., Chairman Peter R. Almond, Ph.D.

Judith Brown Melvin L. Griem, M.D.

Carol S. Marcus, Ph.D.,M.D.

Joan A. McKeown t Robert M. Quillin, M.S.P.H., M.S.

Judith Anne Stitt, M.D.

Dennis P. Swanson, M.S., B.C.N.P.

David Woodbury. M.D., FDA Also present: John E. Glenn, Ph.D, Nuclear Regulatory Commission (NRC), (Designated Federal Official for the panel); Carl J.

Paperiello, Ph.D, Director, Division of Industrial and Medical Nuclear Safety, NRC; Larry W. Camper, Section Leader, Medical and Academic Section, NRC; Daniel S. Berman, M.D.; and Louis K.

Wagner, Ph.D. (ACMUI members-designate, whose appointments to the Committee are not yet finalized, and who attended by invitation).

John E. Glenn, Ph.D., NRC, officially opened the meeting at 8:10 a.m. May 19, 1994. Dr. Glenn announced that Dr. Siegel has an apparent conflict with respect to the review of the training and experience of a physician requesting approval as an authorized user, because part of that physician's training was obtained at an institution that is affiliated with Dr. Siegel's home institution. Dr. Siegel will therefore recuse himself during the discussion of the application. In addition, Dr. Carol Marcus, who is the author of two petitions for rulemaking, will therefore recuse herself from any discussions of these rulemakings in her capacity as a committee member: 1) Proposed amendments to 10 CFR 35.75, " Release of Patients Containing Radiopharmaceuticals or Permanent Implants," and 2) Proposed amendments on " Preparation, Transfer, and Use of Byproduct Material for Medical Use."

n Cl4011 9 127- y

-- . . . , , --- a

Carl J. Paperiello 2 Dr. Glenn then introduced the members and members-designate of the Committee.

The ACMUI discussed the issues and made the recommendations indicated below.

I. HEREGt "Manacement of Radioactive Material Procrams at Medical Facilities" Larry W. Camper and Janet Schlueter, of NRC staff, provided a summary discussion of the development of the NUREG document and the comments that have been received to date. Mr. Camper indicated that the purpose of the document was to provide guidance on management issues associated with medical radiation safety programs of varying size and complexity, but it was not intended to address the technical details of day-to-day operations. The staff has made presentations based on the draft NUREG at meetings of the American College of Nuclear Physicians, the American College of Radiation Oncology, and the Radiological Society of North America. Presentations also are scheduled to be made at the annual meetings of the Society of Nuclear Medicine and the American College of Medical Physics. The document was sent to nine professional organizations for review and comment (this limited number pursuant to office of Management and Budget regulations).

Janet Schlueter provided an overview of the comments received, including comments received rrom the Organization of Agreement States. She presented both general comments on the entire document and specific comments on each chapter, and solicited comments from ACMUI members. The Committee members were also told that additional comments could be provided by letter, fax, or e-mail to Ms. Schlueter within the next week and would be included with the meeting transcript, to be placed ir, the Public Document Room (PDR) at that time.

Dr. Swanson noted, and the ACMUI generally concurred, that senior executives in most medical institutions will not read the document, because of its great length and excessive detail. He also noted that with the inclusion of such detail there is an increased risk of errors of fact or omission; e.g., the document lacks specific information pertaining to nuclear pharmacy services in the sections dealing with services provided by consultants.

Dr. Siegel and others expressed concern that the document should not deal with components of radiation safety programs not under NRC jurisdiction or with " requirements" not currently included in 10 CFR Part 35 (e.g., who must render the official interpretation of a nuclear medicine study) because of a tendency for such " guidance" to be interpreted by NRC, State agencies,

Carl J. Paperiello 3 JCAHO, and others as regulations. The need for strong ,

disclaimers was emphasized. -

Dr. Marcus expressed concern and relayed complaints from several Agreement 4tates that the Agreement States had not been fully involved in the development of the document. Ms. Schlueter responded that a representative from an Agreement State provided input on a continual basis throughout the development of the document. i The general consensus of the Committee was that the NUREG does fulfill the purpose of providing information that, heretofore, was not collected in a comprehensive document. The members stated that the excessive length and detail need to be addressed ~

by careful editing, and that an executive summary for the senior managers should be included at the beginning of the document.

Ms. Brown suggested that the document might be better organized as a series of pamphlets rather than as a single large book.

Dr. Marcus indicated her dissent concerning the quality and I content of this document. She felt it was misleading, of '

scientifically poor quality, and suggestive of a level of radiation hazard associated with medical programs that simply does not exist. (Accordingly, Dr. Marcus did not concur with the answers given below.)

r The Committee agreed that the section in Chapter 9 dealing with radiation accident victims did not belong in this document.

NRC staff posed four specific questions to the Committee: i A. Is the guidance applicable to most medical use programs?

Yes.  ;

B. Are there additional topics that should be addressed, or topics that should be eliminated or reduced in volume?

There were no suggestions of additional topics. The '

Committee believes the volume of material should be reduced ,

and that coverage of activities not regulated by the NRC  ;

should be eliminated or greatly diminished.

C. Is each element of the management triangle - executive ,

management, radiation safety officer, and radiation safety  ;

committee - adequately discussed in relation to the other  ;

elements?  :

)

Yes.  !

i l

1 l

[

. - - - - _. = _ - . . - __- . _ _ _ . ---

{

Carl J. Paperiello 4 D. Are the appendices helpful and comprehensive? [

s Yes. l s

Dr. Siegel strongly requested that the Committee have the opportunity to review the document one more time after incorporation of changes as a result of this round of comments.

Mr. Camper stated that this request would be taken into consideration allowing for the September 1994 publication deadlino specified in the Medical Management Plan and the  ;

extensiveness of the changes that still need to be made.

II. Institute of Medicine / National Academy of Sciences (IOM/NAS) study: '

3 Dr. P. Rathbun of NRC staff and Dr. K. Gottfried of the IOM presented an overview of the study being conducted by the IOM Committee for Review and Evaluation of the Medical Use Program of  !

the Nuclear Regulatory Commission. The NRC has requested that tua IOM conduct detailed independent review and evaluation of the adequacy of NRC's medical use program, as well as provide i recommendations for needed statutory or regulatory changes. The r IOM has established a 16-member committee of experts to conduct a  ;

24-month study. The project has three major goals: ,

(1) examination of the overall risks associated with the use of [

ionizing- radiation in medicine, including an assessment of the j frequency of errors and their consequences associated with the use of licensed byproduct materials by comparison with other i modes of medical treatment, such as chemotherapy or surgery;  !

(2) examination of the broad policy issues that underlie the regulation of the medical uses of radioisotopes; and (3) critical  !

assessment of the current framework for the regulation of the '

medical uses of byproduct material, including assessment of the i appropriateness of the statutory basis for regulation and of the appropriateness of the regulatory relationships that exist among 1 the NRC, Agreement States, the FDA, and various state boards. [

The IOM Committee held its first meeting March 22-24, 1994. It plans to hold five more committee meetings and a public hearing; convene expert panel workshops; conduct site visits; commission j papers from experts on specific topics; and prepare a report that will be subject to the usual rigorous IOM/NAS review process.

Dr. Siegel asked how the IOM Committee will interact with the ACMUI. Dr. Gottfried indicated that this is still being considered. However, the IOM Committee plans to invite Dr.

Siegel to discuss the ACMUI's activities at an upcoming meeting.

There also is a possibility of holding a joint meeting or of having a member of ACMUI join one of the expert panels.

i I

Carl J. paperiello 5 III. Brachytheraov A. Rulemaking on Fractionated High-Dose-Rate (HDR) Brachytherapy Dr. Glenn led a discussion on fractionated HDR therapy in light.

of the problems with administration of these treatments that are starting to appear. Two issues were addressed: (1) What harm or risk, if any, does the Committee believe is associated with the levels of errors that have been seen? 2) What is the appropriate threshold for misadministrations or recordable events for fractionated HDR doses?

Dr. Glenn showed data indicating that the frequencies of teletherapy and radiopharmaceutical therapy misadministrations have remained fairly constant or decreased in the last few years.

However, there is an apparent increase in the number of administration errors with brachytherapy procedures, particularly with HDR therapy. Dr. Glenn requested that ACMUI assist the NRC in understanding these errors and their significance.

Dr. Stitt indicated that NRC should focus its attention on HDR therapy, where fractionated administrations are similar in administered dose to fractionated teletherapy administrations.

She stated her belief that NRC will be seeing more and more  ;

crrors with the use of HDR brachytherapy.  ;

Dr. Glenn pointed out that the Quality Manageroent rule (10 CFR 35.33) currently does not define an error in an HDR therapy fraction as a misadministration or a recordable event if the total dose is equal to the prescribed dose. He asked if the problem is important enough for NRC to require reports of these l errors (e.g., by order / license condition) until such time that a l rulemaking can be prepared. The Committee consensus was that  ;

reporting is appropriate for doses differing by greater than 20%  !

from the calculated / planned fractionated done. Dr. Marcus i dissented, in part, indicating that an arbitrary limit on dose i variance was not sensible, and that physicians should be allowed to prescribe doses as a range. The goal at present should be to obtain enough information regarding this problem to allow the problem to be evaluated adequately. 1 B. Dr. Glenn led a general discussion of misadministrations involving brachytherapy treatment that involve:

(1) misplacement of the source, or (2) source movement due to equipment malfunctions, inadequate immobilization of the applicator during the implantation procedure, or patient intervention. '

Several questions were posed to the committee.

+

What standards are already in place by professional l

i i

• 1 l

l Carl J. Paperiello 6 l

medical organizations?

Dr. Stitt commented that there are standards in the published literature pertaining to proper techniques for placement of gynecologic applicators. The American Brachytherapy Society has addressed this to some extent.

Dr. Almond stated that the American Association of Physicists in Medicine has recently published a comprehensive quality management program for radiation oncology (in Medical Physics).

Is there a need for quality assurance checks and measurements similar to those used in teletherapy? What could NRC do to prev (nt or minimize the problem? Who determines the schedule for preventive maintenance for devices, and who performs preventive maintenance? What type of training is provided if someone other than the manufacturer will do maintenance?

The ACMUI members indicated that the device manufacturer usually performs source exchange and preventive maintenance.

What types of tests / checks are performed at source exchange? Do any professional medical organizations have existing standards on calibration of brachytherapy sources?

Dr. Almond stated that general standards had been  :

developed, and that the AAPM and other professional  ;

groups were working on more specific standards.

What is the standard of care with respect to proper placement and operation of other implar'~1 devices in the medical profession?

Dr. Almond commented that, with HDR, there are very detailed quality assurance checks that are performed

• regularly to ascertain that the sources are located in the right position and the equipment is working correctly. These have been developed by professional organizations. With manual afterloading, there are, at least in his institution, procedure manuals that state specifically what quality assurance steps need to be performed. Dr. Stitt commented that there are both visual and fluoroscopic checks performed.

Does the Committee feel that existing standards and procedures are adequate?

Dr. Siegel stated that there appears to be some

l l

l l

Carl J. Paperiello 7  ;

l potential problems in this area that need to be  ;

addressed by practice standards or by regulation, but the Committee does not have sufficient information or collective expertise at the moment (with Dr. Flynn absent from the meeting) to make specific recommendations at this time.

The Committee agrees that there is problem. In the short term, there is a need for reporting requirements.

Many specific issues and problems were discussed for which the Committee was not presently able to formulate clear solutions. Dr. Siegel suggested that this topic might warrant appointing a subcommittee of ACMUI or holding a workshop to review the problem in depth and to determine what areas need to be addressed by new guidelines or regulations.

IV. Inadvertent Administration to the wrone Patient and Patient Notification Issues I,arry Camper provided an update on these two issues that had last been discussed with the Committee during the November 1993 meeting.

Wrone Patient This issue relates to those cases where a patient receives a radioactive drug or radiation exposure from a nuclear medicine or therapy procedure, where none was intended. The issue involves the applicability of the provisions of 10 CFR 20.1301 to the administration of a radiopharmaceutical to the wrong patient.

Section 20.1301 limits the dose to a member of the general public to 100 mrem in any one year, and would apply if the " wrong patient" is considered to be a member of the general public.

Conversely, the definitions of recordable events and misadministrations in 10 CFR 35.33 would be applicable if the

" wrong patient" is considered to be a patient. The staff submitted a Commission paper outlining three options for determining which is the prevailing regulation: (a) Part 20 is the controlling regulation, because the " patient" is considered a member of the general public who was not intended to receive byproduct radioactive material or the radiation therefrom; (b) Part 35 is controlling because the exposure occurred as the result of an error in administering to any patient a radiopharmaceutical or the radiation from byproduct material; or (c) the issue requires clarificatien through rulemakina and the Staff should exercise discretion during the interim until rulemaking has been completed. The staff sought a determination from the Commission whether a recent " wrong patient" event of this type was a violation of 10 CFR Part 20, as well as guidar.cc

Carl J. Paperiello 8 1

for dealing with future cases. l In response the Commission made the determination that there is no violation of 10 C'R Part 20 in the cited case, and the staff should proceed with rulemaking to clarify that the medical administration of byproduct radioactive materials or the radiation therefrom to a patient (which includes a wrong patient) is the exclusive province of Part 35. The staff was also directed to seek public comments on: (1) the need for notification following errors in administration where no ,

administration was intended and the threshold for misadministration was not exceeded; (2) whether there are there practical ways to apply 10 CFR Part 20 to such inadvertent administrations without defeating the policies underlying the Quality Management rule and the current definition of misadministration; and (3) whether notification in these cases would impose recordkeeping and procedural requirements on licensees beyond those explicitly set forth in 10 CFR Part 35.

The followine cuestions were nosed to the Committee: What are the ACMUI recommendations on the issues identified in the Commission response? What are the ACMUI recommendations for definition of " patient" and/or " wrong patient," particularly as they apply to those individuals who are not scheduled to receive byproduct material?

Dr. Marcus recommended separating Part 20 from the issue and specifically suggested that Part 20 should be modified to make it clear that it doer not apply to intentional medical exposure of a patient or an individual presumed to be a patient.

Dr. Siegel stated that the appropriateness of establishing requirements for reporting and notification if the " wrong patient" is considered a member cf the public, or even defining such an event as a reportable event, is a question of resource allocation. In virtually none of these events will anyone be harmed. If a new set of requirements is imposed to address this problem, the Quality Management rule will be unraveled, because licensees will divert their attention away from efforts designed to prevent those errors that have the potential to cause real harm. Additionally, he indicated that patients would often be greatly inconvenienced (by delays or cancelled studies) because licensees would have to develop extraordinary procedures to avoid inadvertent exposures of the wrong patient.

Ms. Brown believed that a patient should always be told if he/she was given something that was not intended. Tne response was that there are notification requirements in Part 35 when certain dose limits are exceeded. Dr. Wagner commented that the need to notify the patient is based on the standards of ethical practice, but has nothing to do with the small radiation doses in these s

Carl J. Paperiello 9 circumstances (and thus does not warrant regulation by NRC).

The Committee agreed that the best solution is that Part 20 should be modified to clearly discriminate between a member of the general public and a patient. The committee further agreed that recordkeeping requirements would impose an undue burden on licensees.

There was thus a consensus that a rulemaking should be undertaken to clarify that the medical administration of byproduct radioactive material or the radiation therefrom to a patient, which includes even a " wrong patient," is the exclusive province of Part 35.

Mr. Camper questioned whether it would be advantageous to attempt to define " patient" or to clarify instead what is meant by " wrong patient?" After considerable discussion, it was concluded by the ,

ACMUI that such an effort would be unnecessary. A " wrong l patient" is still a patient if so presumed by licensee staff who intentionally administer radioactive material or radiation to that individual for a medical use (including medical research).

10 CFR Part 20 provisions should not apply to such intentional exposures.

Eatjent or Responsible Relative Notification:

Dr. Siegel stated for the record that he had made a request through Dr. Paperiello that one or more individuals from the Office of General Counsel attend the ACMUI meeting to help the Committee understand the legal aspects of this issue from NRC's point of view. The Committee was told that none of the OGC staff would attend or were willing to attend, and no one from OGC will participate in this discussion. Dr. Siegel indicated his disappointment regarding this apparent unwillingness of OGC to l deal with these issues in an open public forum.

Dr. Patricia Holahan presented a discussion of the issues l involved with patient notification. An Information Notice was i issued in May 1993 dealing with misadministration notification j and reporting requirements; this was prompted by data gathered from the regions on therapeutic misadministrations indicating that compliance with the notification requirements in 10 CFR Part 35 was inadequate.

Following the issuance of this Information Notice, NRC has received responses from several licensees indicating that the requirements are still being misinterpreted, the ACMUI raised certain questions about patient notification at its November 1993 meeting, and NRC staff identified several issues internally that needed additional clarif.ication. The staff conferred with the OGC on the interpretation of the current misadministration rule,

I l

i Carl J. Paperiello 10 j and based on the guidance received, a draft Information Notice has been prepared. This draft document was provided to the ACMUI members for review before this meeting.

Six issues are addressed in the draft Information Notice:

Notification of the patient's responsible relative (or guardian) is required in those cases where the patient is a legally competent adult and the referring physician ha.s informed the licensee, that based on medical judgement, telling the patient would be harmful.

Dr. Siegel stated that there is a problem with this interpretation, because if it is decided that telling the '

patient would be harmful, but it is necessary nonetheless to notify a responsible relative, who most often will be the patient's spouse, the licensee cannot insure that the relative will not immediately inform the patient. This could potentially be more harmful than if the referring physician or licensee just notified the patient directly.

If concern for the occasional patient who would be harmed by notification is of any importance to the NRC, the way the rule is written (or being interpreted) must be changed. If the NRC 4 conversely believes that society's greater good is served at all times and in all circumstances by notification, the rule '

must also be changed to indicate that notification is mandatory. As currently written (or as currently being interpreted) the responsible-relative notification requirement is " double-talk."

Dr. Siegel further stated that, if the rule is changed to require notification irrespective of the potential for harm to the patient, the term "respons.ible" should be deleted as a modifier of " relative"; no leg. illy competent adult has &

" responsible" relative. Additionally, the rule should be modified to include an immunity provision that protects the ,

physician from liability for breach of confidentiality I (because the physician is compelled by law to do so).

Dr. Holohan stated that, according to an opinion sought by NRC from the legal staff of the American Medical Association (AMA), the physician is already protected from liability for disclosure, if disclosure is required by law. An attorney from the American College of Radiology, Mr. Tom Greeson, who was recognized by the Chair to speak as a member of the public, stated that he had some concerns as to whether or not the AMA could be construed as having actually recommended that this notice is appropriate, particularly regarding the discussion about qualified immunity / breach of confidentiality with notification. He asserted that Dr. Siegel is correct in

Carl J. Paperiello 11 his statements that the protection for the physician would need to be incorporated into the rule. If a " responsible relative" is told, how can one ensure that confidentiality will be protected? Also, to what extent can the prescribing physician (the radiologist, the nuclear medicine physician, or the radiation oncologist) intrude into, and actually second-guess, the decision-making of the referring physician? (Dr.

Holohan clarified that the AMA has not formally received the information notice for review and concurrence). Dr. Marcus accordingly objected to NRC OGC interpreting AMA guidelines, which are not legally binding on physicians, for purposes of this analysis.

Dr. Siegel also pointed out the ambiguity in the term

" responsible relative." Is a next of kin, who is a distant (but the only) relative of a patient and has not had contact with the patient for many years, really a " responsible relative"?

Documentation of a referring physicians's decision not to notify the patient.

Total reliance is placed on the referring physician to notify the patient, when the referring physician elects to do so.

NRC is trying to clarify that the licensee should either confirm that the notification has been made or document and evaluate the referring physician's reason for not informing the patient. Dr. Siegel questioned whether a letter from the referring physician simply stating that "in my medical judgement, informing the patient would be harmful to the patient" would be adequate documentation of the " reason." NRC staff agreed that that would be sufficient.

Licensee's responsibility to provide a written report to the patient when the patient has been notified, regardless of whether the patient was initially notified by the licensee or the referring physician.

The ACMUI agreed that this was clearly required by the current regulations and was appropriate.

+

Retention of misadministration records There have been some questions as to whether or not there was a requirement to maintain copies of reports sent to the patient and all records associated with the misadministration.  !

The ACMUI asked for clarification about which of the medical i records and other documents developed during an investigation of a misadministration must be retained to satisfy NRC requirements.

l I

i i

Carl J. Paperiello 12 by NRC to be misadministrations. Notification ofermined NRC Operations Ce but also noted that adherence to the " letter ,

o of the law" this extent bordered on the ludicrous.

Definitions of prescribing and referring physician physician and referring physician.The Committee ng discussed the defin Dr.

term " prescribes" is not clear because sometimes s the theSiege

" prescription" is not a patient-specific order (written directive but is a direction in a procedure manual. Dr.

Swanson re) commended changing the wording es."

to "determin definition this is simplyofnot referring correct. physician should be ,

ndeletedThe the because Com V.

American Osteooathic Board of Radioloav Certification NRC requested that the Committee review the training standards and board Board certification of Radiology (AOBR)requirements of the American Osteopathi c recognition of AOBR certification in Radiation Oncology asin relation t sufficient in accordance to fulfill with 10 theCFR requirements 35.930, to be an authorized u ser of radiopharmaceuticals." " Training for therapeutic use 10 CFR 35.930,if the basic standards meet the minimum training rThe Com recognized by NRC in 10 CFR 35.930.and if such certification by the AOBR should TheAOBR the ACMUI acknowledged that the training standards sa e t bli Association (with the concurrence of the American Osteopathic shed by

[AOA))

CFR 35.930.

Dr. Marcus expressed concern that any board wouldmet set as its goal the minimum requirements of the NRC .

Dr. Siegel pointed out, however, approved Education (ACGME by The Accreditation Council on Graduate Med (of ten three year)s,) there is usually a minimum period of one year with the new special for training programs to come into compliance requirements.

have similar policies. Presumably, the AOA and AOBR NRC over the last year by the AOBR suggests that thReview of the documents e Board minimum training requirements of the NRC ine order to achie

Carl J. Paperiello 13 deemed status. Dr. Siegel thus asked what is the evidence that osteopathic radiation oncology training programs are now in compliance and, if not, when can full compliance be expected?

Jhat should be the real start date for this deemed status, and should there be any grandfathering?

The consensus of the ACMUI was that the special requirements for this residency program as currently described are consistent with the requirements of Part 35, with the issue of when the timing of deemed status should be granted remaining open. The AOBR should be asked to document whether its training programs have already implemented the necessary changes, in which case, deemed status could be granted now for newly certified diplomates. If not, the timing of the rule change should be predicated on when the AOBR indicates that all of its new diplomates will have had the required training.

VI. Status Report on Proposed Amendments to 10 CPR 35.71t

" Release of Patients Containinc Radiopharmaceuticals or Permanent Implants Dr. Marcus was recused from discussion as a Committee member as she submitted the petition for this rulemaking.

Kitty Dragonette, Office of Research, provided a status report on this rulemaking. The Commission has acted on this proposed rule, and has agreed with the staff that Part 35 should govern the release of patients from medical confinement, but modification to 10 CFR 35.75 will be necessary. A Staff Requirements Memorandum was issued on May 11, 1994 without any changes in the proposed rule text, regulatory guide, or the regulatory analysis. The modification to 10 CFR 35.75 was that patients may not be released if the potential dose to a member of the public could exceed 500 mrem per year. If there is a potential for a member of the public to receive a dose in excess of 100 mrem per year, the licensee must provide the patient with instructions on procedures to minimize the dose. Sections 20.13 01 (a) (1) (1) and (2) were modified to state that doses received from patients are beyond the licensees control and do not have to be considered in complying with the 100 mrem per year public dose limit or the 2 millirem per hour dose-rate limit.

One issue that has not previously been discussed with the Committee is the consideration anc evaluation of the potential exposure to a nursing infant. The intent is to treat a nursing infant the same as any other member of the public. A concern was raised by the Committee that this does not appear to provide any leeway for a physician to perform a study because of medical need, regardless of the patient's breast-feeding (or pregnancy) status. The response was that if the woman agrees to stop breastfeeding and if the licensee has made a good faith effort in

Carl J. Paperiello 14 complying, then the licensee has met the intent of the rule. l Further discussion revealed that this is a very sensitive issue and needs to be looked at more closely.

VII. Status ReDort Qn ProDosed Amendments on " Preparation, Transfer, and Ugo of Bvoroduct Material for Medical Use" Sher Bahadur, Ph.D., Office of Research presented a status report on the above rulemaking. The proposed rule was published in June 1993. The NRC received 284 comments, with the vast majority of the comments (280) supporting the rule. The final rule text remains essentially the same as the proposed rule. The final rulemaking package should be submitted to the EDO with the guidance documents by the Fall of 1994. The staff is making efforts to ensure that the final rule becomes effective by January 1, 1995, when the interim final rule expires.

1 VIII. Status Report on " Administration of Bvoroduct Material or Radiation from Bvoroduct Material to Patients who may be Preanant or Nursinc" Sher Bahadur, Ph.D., Office of Roccarch presented a status report on this rulemaking. This rulamaking no longer covers the intentional exposure of the breast-fed child, which will now be covered under the proposed rule on patient release criteria (presented by Kitty Dragonette). NRC's proposed approach for minimizing unplanned exposures is to require licensees to develop a procedure manual for diagnostic administrations. If there are any breaks in the procedure, then the inadvertent exposure would be classified as a recordable event. The ACMUI previously had suggested that NRC should establish a threshold below which reporting or investigating such events would not be necessary.

The ACMUI also suggested that the office of Research should contact the National Council on Radiation Protection and Measurements (NCRP) to obtain advice on setting a reporting threshold. A contract with NCRP has been established through Brookhaven National Laboratory. The HCRP commentary is due in June, at which time NRC staff will evaluate and finalize the t rulemaking.

Dr. Siegel requested that the ACMUI be given the opportunity to comment again on the modified versions of these rules as part of the agenda for the next meeting.

II. Status of Abnormal Occurrence criteria The Commission has reviewed the staff's suggestions on amending the criteria for abnormal occurrence. At this time, a Staff Requirements Memorandum has not been finalized and sent to the staff.

Carl J. Paperiello 15 I

Dr. Siegel adjourned the open session of the meeting for the day at 4:20 p.m. on May 19, 1994. The ACMUI then held a closed session to discuss training and experience of a physician ,

applying for authorized-user status.

May 20, 1994 Dr. Siegel reconvened the meeting at 8:30 a.m. on May 20, 1994.

X. ACMUI Bylaws The draft Bylaws for the Committee were discussed. An overview of the Federal Advisory Committee Act was presented by Susan Fonner, Office of General Counsel (OGC). The Committee was told that specific questions should be passed to OGC through the Chairman of the Committee.

The Bylaws were discussed and revised item by item, incorporating the Committee member's comments and comments provided by Ms.

Fonner.

The Bylaws will be edited based on these changes, and resubmitted to the Committee for review to ensure consistency with the changes made at this meeting. The corrected Bylaws are attached as an appendix to these minutes. If also approved by the Director of NMSS, the revised Bylaws will be submitted to the ACMUI for approval during the next regular meeting of the Committee, in the Fall 1994.

XI. hCMUI Preparation for the Commission Briefina Dr. Siegel opened the floor to discussion on possible topics for a Commission briefing. Proposed dates from the Commission are during the weeks of July 11 and July 18, 1994 (excluding July 19, 1994). The Committee members agreed that, if there are not any pressing issues that warrant a meeting, they would prefer not to have a Commission briefing at this time.

Dr. Marcus presented a few ideas for a meeting. She believes the Committee should discuss the need for a paradigm shift in the medical program and NRC's role in the regulation of medical use of byproduct material. NRC should be directing its attention to eliminating dual regulation (such as by EPA); eliminating intrusion into medical practice; reducing the excessive paperwork required by documentation requirements in the regulations; and the problems with low-level waste disposal issues. She stated that NRC needs to look more at the economic side of things and how the regulations are putting undue cost burden on licensees.

She believes that " harm" at low radiation doses needs to be re-evaluated. Also, the conflicts with Agreement States that are currently under assessment need to be addressed.

Carl J. paperiello 16 Dr. Siegel stated that he was not sure the Committee was ready to address these broad issues. The issues have not been discussed recently by the Committee, and it would be difficult to present a comprehensive review of these issues at an upcoming briefing. He does not believe that anything the Committee has to say will have much impact while the IOM/NAS study is ongoing. Rather, he would like to be certain that committee has input to the IOM/NAS panel.

Ms. Brown felt we should address the concerns with brachytherapy issues that were discussed in this meeting. Dr. Siegel stated that the brachytherapy issues also have not been developed to the stage of making a presentation to the Commission. Such a presentation would be more appropriate after the proposed subcommittee is convened or a workshop has been held.

Mr. Swanson expressed a concern with the lack of responsiveness of OGC pursuant to the Committee's requests for legal opinion to help it in its deliberations.

Dr. Siegel stated that issues discussed at this meeting regarding patient notification and breastfeeding issues could be addressed.

Dr. Siegel proposed to the Committee that there are not enough issues of importance to warrant the cost of a Commission briefing or the effort to prepare for a briefing. The Committee will establish an agenda if the Commission believes that it is crucial to meet with ACMUI. The Committee agreed with this proposal.

XII. ACMUI Membership One final issue discussed was the professional expertise needed on the ACMUI in order to provide valid technical advice to NMSS and to the Commission on all types of medical use of byproduct material. With the departure of Dr. Almond from the ACMUI after this meeting, the Committee will not have adequate expertise in radiation therapy physics. It was moved and approved unanimously that the ACMUI urges the Commission to appoint a therapy physicist to the Committee.

Dr. Glenn officially closed the meeting at 11:40 a.m.,

May 20, 1994.

& l Barry A. Kiegel, M.D., Chair 6an -

TJ{ 0(Me. (1995 Date

DRAFT ACMUI June 23, 1994 U.S. NUCLEAR REGULATORY COMMISSION NUCLEAR MATERIALS SAFETY AND SAFEGUARDS ADVISORY COMMITTEE ON MEDICAL USES OF IS0 TOPES BYLAWS

4

~

DRAFT CONTENTS Page

1. Scheduling and Conduct of Meetings .......... I

2. Minutes . . . . . . . . . . . . . . . . . . . . . . . . 2

3. Appointment of Members ................ 2

4. Conduct of Members .................. 3

5. Amendments ...................... 4 1

1 i

s . -

. . . - - - -. = _ _ - _ -

DRAFT .

PREAMBLE These Bylaws describe the procedures to be used by the Advisory Committae on Medical Uses of Isotopes (ACMUI), established pursuant to 10 CFR 1.19(a), in performing its duties, and the responsibilities of the members. For ,

parliamentary matters not explicitly addressed in these Bylaws, Robert's Rules  :

of Order will govern. .

These Bylaws have as their purpose fulfillment of the Committee's responsibility to provide objective and independent advice to the Commission through the Office of Nuclear Material Safety and Safeguards, with respect to the development of standards and criteria for regulating and licensing medical uses of byproduct radioactive material or the radiation therefrom. The procedures are intended to ensure that such advice is fairly and adequately obtained and considered, that the members and the affected parties have an adequate chance to be heard, and that the resulting reports represent, to the ,

extent possible, the best of which the Committee is capable. Any ambiguities '

in the following should be resolved in such a way as to support those objectives.

r

l l

DRAFT <

1. Schedulina and Conduct of Meetinas The scheduling and conduct of ACHUI meetings shall be in accordance with the requirements of the Federal Advisory Committee Act (FACA), as amended,10 CFR Part 7, and other implementing instructions and regulations as appropriate.

1.1 Schedulina of Meetinas:  !

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

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

1.1.2 Special meetings will be arranged as the need arises.

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

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

1.2 Heetina Aaenda:

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

Before the meeting, the Chair of the Committee and the Designated Federal Official for the Committee will review the findings of the Office of the General Counsel regarding possible conflicts of interest of members in relation to agenda items. Members will be recused from discussion of those agenda items with respect to which they have a conflict.

1

DRAFT 1.3 fonduct of the Meetina:

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

1 3.2 The Chair of the Committee will preside over the meeting. The Designated Federal Official will preside if the Chair is absent, if the Chair is recussed from participating from discussion of a particular agenda item, or if directed to do so by the Commission.

1.3.3 A majority of the current membership of the Committee is required to constitute a quorum for the conduct of ACMUI business.

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

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

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

Any members who disagree with the consensus shall be asked to state ,

their dissenting views for the record. Any Committee member may request that any consensus statement be put before the ACMUI as a formal motion and subject to affirmation by voting. No Committee position is final until it has been formally endorsed, and the minutes written and certified.

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

2.2 A draft of the minutes will be prepared by the Chair, assisted by the NRC staff, and made available as soon as practicable to the other members. After receiving corrections to the draft minutes from the Committee members, the Chair will certify the minutes. By certifying the minutes, the Chair attests to the best of his or her knowledge to the completeness and technical accuracy of the minutes.

2.3 Copies of the certified minutes will be distributed to the ACMUI 2

DRAFT e members. They will then be forwarded to the Public Document Room, with ,

only those deletions required by law. l

3. APP 0INTMENT OF MEMBERS 1 3.1 The members of the Committee are appointed by the Commission, which determines the size of the Committee. The NRC will solicit nominations l by notice in the Federal Register and by such other means as are l' approved by the Commission. Evaluation of candidates shall be by such procedures as are approved by the Commission. The Commission has the final authority for selection. The term of an appointment to the i Committee is two years, and the Commission has determined that no member may serve more than three consecutive terms. t 3.2 The Chair of the Committee will be appointed by the Commission. The ,

Chair will serve for a period of two years, being eligible for -

reappointment by the Commission for two additional two-year terms.

4. CONDUCT OF MEMBERS .

t 4.1 If a member feels that he or she may have a conflict of interest with regard to an agenda item to be addressed by the Committee, he or she  !

should divulge it to the Chair and the Designated Federal Official as l soon as possible, but in any case before the Committee discusses it as ,

an agenda item. Committee members must recuse themselves from j discussion of any agenda item with respect to which they have a conflict of interest. -

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

4.3 Members of the ACMUI are expected to conform to all applicable NRC rules ,

and regulations.

5. AD0PTION AND AMENDMENTS 5.1 Adoption of these bylaws shall require a vote of two-thirds of the current ACMUI membership and tne concurrence of the Director of the Office of Nuclear Material Safety and Safeguards.

5.2 Any member of the Committee or NRC may propose an amendment to these Bylaws. The proposed amendment will be distributed to the members by the Chairman and scheduled for discussion at the next regular Committee 3

DRAFT meeting.

5.3 The final proposed amendment may bE. voted on not ea rlier than the first regular meeting after it has been discussed at a C;mmittee meeting pursuant to Paragraph 5.2.

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

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

4