ML20195D414
| ML20195D414 | |
| Person / Time | |
|---|---|
| Issue date: | 11/16/1998 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-98-263, SECY-98-263-01, SECY-98-263-1, SECY-98-263-R, NUDOCS 9811180035 | |
| Download: ML20195D414 (26) | |
Text
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RELEASED TOTHE PDR f, h h I!l% k f kbJ 5 j
.B 3 i . date in!tials j .............e.....eee.a POLICY ISSUE November 9.1998 (Notation Vote)
. EQB: The Commissioners FROM: William D. Travers Executive Director for Operations
SUBJECT:
PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL PURPOSE:
To provide the Commission with early feedback on significant concems raised at the public meetings on the proposed revision of 10 CFR Part 35, " Medical Uses of Byproduct Material;" to obtain Commission direction on performing a risk assessment on the medical uses of byproduct material,and extending the public comment period; and to request a " point of contact" from each Commission office for this rulemaking.
BACKGROUND:
In its Staff Requirements Memorandum (SRM) - COMSECY-96-057, " Materia!s/ Medical Oversight (DSI 7)," dated March 20,1997 (Attachment 1), the Commission directed the revision and restructuring of Part 35 into a risk-informed, more performance-based regulation, (i.e., focus Part 35 on those procedures that pose the highest risk, from a radiation safety standpoint). Therefore, during the development of the regulation, the staff considered information on risk provided by members of the public and professional societies, professional medical standards of practice, and event databases maintained by NRC, to determine where oversight of low-risk activities could be decreased and where there needed to be continuation, or even broadening, of the regulations governing high-risk activities. As a result of these considerations, staff believes that the proposed rule is risk-informed and in accordance with p both the Commission's direction and the strategy and goals for nuclear materials safety \ l outlined in Strateoic Plan: Fiscal Year 1997-Fiscal Year 2002 (pp.9-12, September 1997).
CONTACTS: Catherine Haney, NMSS/IMNS (301) 415-6825 }
Diane S. Flack, NMSS/IMNS (301) 415-5681 h 3 h hb 7n g h i s 9811190035 981116 PDR SECY
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The Commissioners 2 Throughout the development of the proposed rule and associated guidance, public workshops were held and opportunities for comment from potentially affected parties were provided, which are not provided by the typical notice and comment rulemaking process. The Federal Register notica for the proposed rulemaking summarized comments received during the developmental stages and noted that there would be a 90-day public comment period that closes on November 12,1998 (63 FR 43515, August 13,1998).
During the public comment period on the proposed rule, significant regulatory issues have been discussed at facilitated public workshops in San Francisco, Kansas City, and Rockville, between August and October 1998. In addition, these issues were discussed at a Part 35 workshop held in conjunction with the All Agreement States Meeting in October 1998.
Summaries of the comments made at the facilitated public meetings have been prepared for the meetings held in San Francisco and Kansas City (Attachment 2). The summary of the Rockville meeting is being prepared and will be forwarded under separate cover. Transcripts of the facilitated public meetings and the workshop are available on the NRC rulemaking website. At the Rockville meeting, the participants specifically requested that two of their concerns - the need for a risk assessment and extension of the public comment period -- be forwarded to the Commission before the end of the comment period.
On October 30,1998, a formal request for an extension of the comment period, to allow for the development of the risk analysis and rule accordingly, was submitted to Chairman Jackson by eight professional organizations (Attachment 3). The letter indicates that the 90-day comment period provides " . insufficient time to offer meaningful comments on the proposal. " It also states that " Concern was raised that the current activity surrounding risk
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analysis (the uncompleted report from the Nuclear Byproduct Material Risk Review Group) is 1 not adequate." These organizations offer to " . present to the Commission a proposal that l describes in detail the type of risk analysis that [they) believe must be performed along with an estimate of the time involved." Finally, the request states that " . operating under the existing rules on a temporary basis, in order to develop an appropriate replacement, is preferable to an incomplete and unsupported proposed regulation." The Agreement States endorsed this letter at the recent All Agreement States Meeting.
DISCUSSION:
SIGNIFICANT CONCERNS STATED DURING THE MEETINGS INCLUDED:
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Risk assessment: Some participants believed that NRC has not adequately assessed the risk of the various modalities for medical use because a formal risk assessment was not done. Three major comments were made on the need for a risk assessment:
(1) NRC has not fully accounted for the low risk in diagnostic nuclear medicine; (2) relative risk must be considered because risk can occur from both action and inaction in medicine; and (3) NRC should perform a risk assessment, with stakeholders involved in the selection of the methodology, and publish the results for comment before it proceeds with any revision of its medical use program.
Comment oeriod: The majority of the participants at the public meeting believed that:
(1) the 2-year period for revising the rule and associated guidance did not provide l
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The Commissioners 3 enough opportunity for them to provide input and work with the staff in developing the rulemaking; and (2) the 90-day public comment period was too short to review, I thoroughly understand, and comment on such a major rulemaking. Although the comment period is longer than the minimum 75-day comment period, the participants I
noted that the comment period for Part 35 is no longer than for less significant rulemakings. In addition, some participants stated that the schedule for the i rulemaking should include re-publication of the proposed rule after it has been revised to incorporate the public comments.
Trainino and exoerience: Issues ranged from the broad issue of whether NRC should specify the number of hours of training for various individuals, to modality-specific issues presented by medical specialists (e.g., endocrinologists and cardiologists).
Board certification: Issues include the proposed criteria to review medical specialty boards that want to be examining organizations, and the current process used by boards to approve individuals, Radiation Safety Committee: Concerns were raised over the proposed deletion of the requirement for a Radiation Safety Committee (RSC), because some participants believe the RSC is imperative for effective implementation of a licensee's radiation safety program.
OPTIONS FOR COMMISSION DIRECTION ON THE NEED TO PERFORM A RISK ASSESSMENT AND TO ADJUST THE SCHEDULE FOR THE RULEMAKING:
Ootion 1: Status ouo: Proceed with crocosed rulemakina as aooroved in SRM-98-128.
Pros: Maintains current schedule to revise, restructure, and update Part 35 (e.g., allows for timely incorporation of regulations for therapy modalities and emerging technologies that are not specifically addressed in the current rule).
Current schedule allows time for staff to meet with both the full ACMUI and the ACMUl diagnostic and therapeutic subcommittees to discuss the technical content of the rule.
Meetings with the subcommittees proved very valuable in the development of the proposed rule, because these meetings provided opportunities for discussions on specific modalities and requirements. Staff would continue to use risk information to determine appropriate changes to specific provisions of the proposed rule as part of the analysis of the comments.
Cons: Not responsive to stakeholders' request to extend the public comment period.
Allows less opportunity for stakeholders to review the proposed rule and identify any specific problems, such as a need for clarification of the rule language.
Ootion 2: Extend the comment oeriod for 30 days. but don't oerform a risk assessment.
Under this option, the comment period for the proposed rule would be extended for 30 days
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The Commissioners 4 and no change would be made in the final due date for the rule (Option 2A) or the final due date would be extended for a corresponding 30 days (Option 28).
Pro. Provides additional time for the public and stakeholders to review and submit comments on the proposed rule and the draft regulatory guidance.
Con: Not responsive to stakeholders' comments on performing a risk assessment.
NOTE If Option 2A is approved and the due date for the rule is not extended by the same amount of time that the public comment period is extended, the staff's continued interaction with the ACMUI, public, and medical community during the resolution of the comments would be severely curtailed. For example, staff would not be able to meet separately with the ACMUI subcommittees and still maintain the current schedule, because this time would be needed to evaluate comments. Therefore, the schedule would only permit the staff to meet with the full ACMUI one more time before publication of the final rule. In addition, selection of Option 2A would result in less time for resolution of comments and, therefore, could adversely affect the quality of the final rule.
Ootion 3: Perform a risk assessment and extend the date for comoletion of the rule.
Under this option, the comment period for the proposed rule would need to be signifaniiy extended to accommodate some type of risk assessment: a formal risk assessment for the entire rule (Option 3A); a formal risk assessment focused on the diagnostic modalities (Option 3B); or a relative risk assessment (Option 3C). The participants at the Rockville meeting requested that representatives of the medical community be part of an advisory committee that oversees a formal risk assessment (Option 3A) on the entire rule. This would include their involvement in all the phases of the risk assessment, from selection of the risk assessment methodology to review of the results. A relative risk assessment (Option 3C) would evaluate the risk associated with the use of byproduct materialin medicine versus the risks in other areas of medicine. All the alternatives would entail collecting available information, either on absolute risk or on relative risk in other areas of medicine, with the assistance of stakeholders. The results of the risk assessment would be published for comment and form the basis for the revision of Part 35.
Pro: Responsive to participants' comments that the regulations should be risk-based. The revision would be risk-based, rather than risk-informed. If a relative risk assessment were performed, the rule would be based on the relative risk of all areas of medicine, rather than on the specific risk associated with use of byproduct material in medicine.
l Cons: This option is not consistent with either the Commission's direction to develop a risk-informed rule that is focused on radiation safety (SRM-COMSECY-96-057) or the I strategy and goals for nuclear materials safety outiined in Strateaic Plan: Fiscal Year 1997-Fiscal Year 2002.
The data necessary to perform a relative risk assessment may either not be available or be problematic. The National Academy of Sciences Report on Radiation in i Medicine: A Need for Reaulatorv Reform (National Academy Press,1996) included 1
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The Commissioners 5 I
l both a risk assessment and a discussion of the comparative risk of ionizing radiation in
! i medicine to risks in other medical modalities (Chapter 4). The NAS report concluded !
l that "no comprehensive raw data are available to make exact comparisons" between risks of medical modalities (pg.124). Both ACMUI (at a May 8,1997, Commission briefing) and the NAS Report (pg.128) recognized that quantifying levels of risk in
! radiation medicine is problematic.
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l Significant additional time and resources would be needed to perform the risk '
assessment and complete the rulemaking.
OBTAIN " POINT OF CONTACT" FROM EACH COMMISSION OFFICE The staff requests that each Commissioner designate a member of his/her office to serve as a point of contact with the staff for this rulemaking. This would be especially useful if the -
current schedule for the rulemaking, to be completed in June 1999, were retained. Having a point of contact would enable: (1) the Commission to be promptly informed of any significant issues raised by the stakeholders and to be provided with options for resolution of these l {
' issues; and (2) the staff to receive timely Commission direction on resolution of these issues and to continue with development of a final rule within the approved schedule. ;
RESOURCES:
Option 1 (status quo) would have no resource impact. Option 2 (extend the comment period) l would result in at least a 0.5 FTE increase in the resources identified in the FY 2000 budget ;
L submission for the rulemaking. Option 3 (perform some type of risk assessment) would !
require different level of resources, depending on which sub-option is approved. Option 3A l would require the most resources because it includes a formal risk assessment on the entire rule; estimated resources for this sub-option are up to 10 FTE over a 5-year period plus several million dollars for an outside contract to perform the risk assessment. None of these l resources are included in the present budget submission or in the Operating Plan.
RECOMMENDATION:
The staff recommends Option 2B which is responsive to the unanimous request of the participants at the Rockville workshop for extension of the comment period and will not unduly delay the final rule.
COORDINATION:
The Office of the General Counsel has reviewed this paper and has no legal objection. The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no objections. The Office of the Chief information Officer has reviewed i
the proposed rule for information technology and information management implications and concurs in it. ~
I
)k Ne ^ A William D. Travers Executive Director I
for Operations Attachments:
- 1. SRM-COMSECY-96-057, dtd 3/20/97
- 2. Summaries of Public Meetings
- 3. Letter to Chairman Jackson, dtd 10/30/98
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-Commissioners' completed vote sheets / comments should be provided directly to the Office of the Secretary by COB Tuesday, November 10, 1998.
Commission Staff Office comments, if any, should be submitted to the-Commissioners NLT November 10, 1998, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised-of when comments may be expected.
DISTRIBUTION:.
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Action: Paperiello/NMSS <
Morrison, RES i So UNITED STATES n NUCLEAR REGULATORY COMMISSION n a j WASHINGTON,0.C. 20555-0001 Norry k ..... j/ March 20, 1997 Blaha Bangart, SP n en m ny Ross, AE00 l
J MEMORANDUM TO: L. Joseph Callan Execut've D' rector for Operations FROM: Joh' C.
b oy e, Se : rct ary
SUBJECT:
S AFF REQUIREMENTS - COMSECY-96-057 MATERIALS / MEDICAL OVERSIGHT (DSI 7)
With respect to the overall materials program, the Commission continues to support its preliminary views on this issue which were a combination of two options -- Continue the Ongoing Program with Improvements (Option 2) and Decrease Oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities (Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory l oversight to include one or more of the higher-risk activities identified in Option 1.
With respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the l i
Federal agency involved in the regulation of ionizing radiation in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views. In the longer term, the Commission would be willing to consider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.
In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary. The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the program the staff should consider the following:
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! (1) Focusing Part 35 on those procedures that pose the highest risk.
(2) For diagnostic procedures, staff should consider regulatory oversight alternatives consistent with the lower overall risk of these procedures.
(3) The staff should address how best to capture not only relevant safety-significant events, but also precursor events.
to (4) Changing the nomenclature from " misadministration"
" medical event" or comparable terminology.
(5) Part 35 should be redesigned so that it can incorporate necessary regulatory requirements for new treatment modalities in a timely manner.
(6) The Quality Management Program provisions (10 CFR Part 35.32) should be re-evaluated and revised to focus on those requirements that are essential for patient safety, e.g., confirming patient identity, requiring written prescriptions and verifying dose. To the maximum extent possible, the requirements should be revised to be risk-informed. Given this objective, a mixed approach of performance-based rules and otherwise prescriptive regulations should be pursued.
(7) The staff should consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they meet NRC needs.
(8) The staff should consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking process but would be less consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination.
The staff's program to implement the above should be submitted 1997.to the Commission for its consideration no later than June 6, The program should target June 30, 1999 as the date for This rulemaking and completing the rulemaking associated guidance process.is a very high priority for the development Commission. The Commission is prepared to provide additional resources to the extent necessary to complete the rulemaking process on this cchedule.
(SECY Suspense: 6/6/97) 9700065 (NMSS/RES) (EDO - Program) (SECY Suspense: 6/30/99) 9700065 (NMSS/RES) (EDO - Complete Rulemaking)
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SUMMARY
OF PUBLIC MEETING ON PROPOSED REVISIONS TO PART 35 AND THE NRC'S t l
MEDICAL POLICY STATEMENT l San Francisco, California August 19 and August 20,1998 1
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1 Prepared for I Office of Nuclear Material Safety and Safeguards by ICF Corporation under Contract NRC-04-95-065 September 11,1998 Attachment 2
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INVITED PARTICIPANTS l
[ . FRANCIS CAMERON, Facilitator i 4 DALE AUSTIN ROBERT 3. LULL, M.D.
NIKKI HOBSON RICHARD HEUSER, M.D. FACC EDGAR D. BAILEY h
MARY PAT MANNING TERRY FRAZEE CHARLIE SHOWALTER ROY BROWN MELISSA C. MARTIN DAVIS LARSON, M.D.
DAVID NEBLETT JAY W. MILLSON KATHY S. THOMAS, MHA, CNMT DONALD A. COOL, Ph.D.
W. A. EHMIG CATHY HANEY l SUSAN MCLAUGHLIN DIANE FLACK 1
DAVID BELK DAVID FAXON, M.D.
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- - ELIAS BOTVINICK, M.D. JOHN EARLE, M.D.
J. JOSEPH PRENDERGAST, M.D.
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- 1. Risk i
A participant presented an analysis prepared by the Society of Nuclear Medicine and the American College of Nuclear Physicians entitled "A Framework for the Regulation of Nuclear Medicine," which he encouraged everyone to read, that stressed the need for a better balance of costs and benefits in the regulation of the medical uses of radionuclides. He encouraged NRC to use voluntary standards and to nnd the least costly and restrictive approaches to regulations.
NRC staff described an internal risk review group that is examining the occupational and public !
exposure risks posed by uses of byproduct material. NRC staff also described how reports on misadministrations and similar data are used to identify generic issues, trigger notices to licensees, support retrospective analyses, and serve as the basis for regulatory changes. A participant noted a 1993 senior management review of risk, and asked that it be made publicly available (NRC staff agreed to see ifit could be released), and asserted that the NRC data showed that less than half of misadministrations are related to diagnostic nuclear medicine. Many result in no harm to the patient.
Participants discussed the obstacles to obtaining a complete assessment of the costs of NRC's regulation of medical uses, including absence of data, confounding variables, and attribution of costs to the correct cause, since regulation and good practice are interrelated. A participant urged NRC to develop a structure that acts as a filter for proposed or existing regulations to assess risks and bene 6ts and to distinguish pseudo-risks, which do not produce real harms, from real risks. Another participant suggested that certain low-risk medical modalities have such a small risk of harm to patients that regulation of them is unnecessary. In addition, careful estimation of the costs of certain regulations would be unnecessary if the risks could be shown to be minimal. Another participant suggested that NRC should require no paperwork for low risk incidents; a low level of documentation for intermediate incidents; and more documentation of high risk incidents.
An Agreement State participant indicated that perceived risk must be taken into account when developing regulations. Patients, in the view of a participant, rely on public or private regulation / supervision without particularly focusing on how the oversight is carried out. They will not be deterred by a perceived risk from obtaining a treatment or other care. Other participants noted that the issue of perceived risk does need to be addressed, and may be best addressed by education rather than regulation.
An Agreement State participant stressed that risk to patients can be related to medical technologists being insufficiently trained, and said that requiring the physician prescribing a dose to be present when the dose is administered could reduce risk of medical events.
A member of the audience asked for clari6 cation concerning how, for example, Section 35.60 requiring a licensee to develop, implement, and maintain regular procedures to limit exposure could be implemented based on the risks of the practice, and why it is necessary, particularly when other parts of the regulations already require licensees not to exceed certain exposure rates. NRC staff explained the proposal to eliminated prescriptive requirements in low-risk areas and give licensees flexibility in developing procedures. For example, prescriptive requirements for shielding radiopharmaceuticals have been deleted and instead licensees are required to develop a procedure for shielding radiopharmaceuticals but, should consider the dose limits and ALARA requirements in 10 CFR Part 20 when developing these procedures.
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- 2. Use ofIndustry Standards A participant from the Federation of State Medical Boards explained that currently 71 State l medical boards license the practice of medicine in the United States, under the Medical Practice Acts regulating physicians. The State Medical Board reviews licensing, discipline, and rules and procedures.
Initial license requirements, which are quite similar from State to State, include, Hrst, graduation from an approved school, accredited by the Liaison Council on Medical Education (LCME); second, completion of approved postgraduate training (from one to three years long) accredited by the Accreditation Council on Graduate Medical Education (ACGME); and third, certifying examinations, consisting ofinitial exams for licensure and/or specialty certi6 cation exams. Disciplinary actions are complaint-driven. The presentation provided additional detail on a number of topics related to licensure and discipline by State boards.
Two potential obstacles were identified to an approach in which NRC depended on the State medical board system oflicensing and discipline and deferred its regulatory scheme: (1) disciplinary actions in one State, including license revocation, would not address a physician who was licensed in more than one State; and (2) several State boards are precluded from sharing information with their counterparts in other States or with other agencies. In addition, the State licensure examinations are for the undifferentiated practice of medicine. It might be difficult to include a component of the examination assessing competence in radiation safety because that would apply to a narrow group of physicians.
The American Board of Medical Specialities has boards that are composed of specialists who develop written and/or oral examinations and requirements for eligibility for taking the examinations.
Most board examinations are taken after completion of a formalized ACGME-approved training program, a residency or followship program in that speciality. Passing a test and obtaining a statement from the training program director that the clinical competency and educational requirements have been met leads to board certi6 cation. Receni6 cation is required about every 10 years. State licensing bureaus, in addition, require continuing education in the specialty area.
In response to a question about whether a medical speciality board could set up a standard to de6ne a medical event, the Federation participant noted that the boards now require that the appropriate dose be given to the appropriate patient. In addition, quality assurance programs are required for hospital accreditation. He also pointed out that the State boards do not conduct unannounced inspections or -
routine investigative activities.
NRC staff noted that professional societies set the standards and guidelines for patient selection and procedures. For example, the Society of Nuclear Medicine has posted practice guidelines for nuclear medicine procedures on the Internet. Standards also have been estabhshed for nuclear medicine technologies. A participant stated that such guidelines generally are followed by hospitals, and are sometimes placed in haspital bylaws therefore, NRC might consider treating a hospital setting differently from an outpatient setting with respect to regulation. The participants indicated that many standards are quite generic, and are not oriented to radiation usage, radiation safety, and appropriate patient application of radiation. Another participant noted that the initial reviewer of compliance with standards of care would be the quality assurance board of that subspeciality in the hospital. If a physician is disciplined at the hospital level, the State bor.rd would be noti 6ed. It would not involve the speciality board. A participant later pointed out, however, that more physicians are practicing without hospital affiliation.
and therefore may not have peers who are observing their standard of care. Two other participants agreed that outpatient settings are likely to be more problematic. Ilowever, some States or boards do outcome analysis of all inpatient and outpatient care.
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Participants suggested that at future public meetings they would be prepared to suggest an l
- alternate regulatory regime based on the accreditation program. One alternative, outlined by a participant, was to have accreditation serve as initial evidence of compliance with professional and )
governmental standards. Such an approach would parallel the mammography program of the Food and l
Drug Administration (FDA). NRC staff encouraged the further exploration of these ideas in the forthcoming public meetings, and a participant stated that a framework for discussion would be p before the Kansas City meeting.
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NRC staff described how NRC would view liceasees use ofindustry standards. Under the proposed rule, an applicant, to satisfy the requirement that it develop, implement, and maintain procedures, would initially only be required to submit its statement that it will develop and maintain l procedures. NRC will not review the contents of procedures. The licensee may develop its own procedures or adopt procedures from a professional organization, giving the licensee the Dexibility to u industry standards. Also, NRC has identified components of some industry standards, that are particularly important to radiation safety, and has incorporated them into the proposed regulations. For example, calibration of dose calibrators is required to be done daily, but the rules do not specify how the )
I calibration should be performed. An industry standard may be relied upon. Similarly, a procedure is required for surveys. The licensee may adopt the survey frequency that is appropriate for its program. In l l
the therapeutic area, in contrast, where the risks are greater, the requirements are more prescriptive. The NRC reviewed industry standards, in particular the American Association of Physicist in Medicine (AAPM) standards, and incorporated key components into the proposed rule.
- 3. Costs and Compliance Issues NRC staff opened the discussion by describing the contents and availability of two documents that calculate the cost of the proposed rule: the Regulatory Analysis, w hich estimates the changes in cost between the current rule and the proposed rule, and the Of6ce of Management and Budget (OMB) submission, which estimates the reporting and recordkeeping costs of the proposed rule. Both documents are available in the regulatory docket. The Regulatory Analysis assesses the costs, health and safety implications, and benents of the proposed rule on a section-by-section basis, and in addition to changes in Part 35 also addresses an amendment to Part 20.
The NRC staff summarized the cost implications of the proposed rule, as presented in the
! Regulatory Analysis, by stating that it estimates the rule will provide cost savings of approximately $6 million, with the most signincant savings resulting from elimination of quality management program requirements and radiation safety committee requirements. Partially offsetting cost increases are expected from changes in the training and experience requirements, particularly in the requirements for i
certifying organizations. Savings for NRC and Agreement States are approximately $1.6 million. Most savings are annual, although some may be one-time savings. The reporting and recordkeeping burden of the proposed rule, as estimated in the draft OMB statement, is reduced from $166 million to $106 l million annually.
One participant suggested that providing greater Dexibility and less prescriptive requirements at some stages of the regulatory process, such as licensing, will almost certainly result in higher costs at i other stages, particularly for inspections. In addition, increased frequency ofinspections (more i
inspections) would also result in a higher burden. An audience member agreed that under a more performance-based approach costs shift from license review to inspection. The inspection costs are greater than the license review savings. NRC staff responded that the change in licensing philosophy was not expected to increase the resource burden in the inspection program. Inspectors would not routinely review procedures on site unless they were investigating a medical event or had reason to look l
6 at the program in greater depth. An Agreement State participant expressed concern about simultaneously having inspectors make more independent judgments about licensees and increasing the inspection interval. Although Agreement States could inspect more frequently than NRC, in some cases there might be economic pressures encouraging them not to eweed the NRC inspection interval.
- 4. En. ment Enforcement developments in the power reactor area that could have implications for materials licensees were described. As a result of reactor licensees' concerns, the Commission has requested a reexamination of Severity Level IV (SL IV) violations--violations of more than minor significance which ifleft uncorrected could become a significant regulatory issue, but below the level of escalated enforcement. For example, a violation might not be cited if the licensee identified the issue and has undertaken corrective action within a short period following NRC inspection. If a violation is cited, a formal response to the violation might not be required from the licensee if the corrective action is already known to NRC.
NRC staff explained that there had been no escalation in the number of SL IV violations for materials licensees, but because the Commission is considering a revision to the structure of the enforcement program, which could affect materials licensees, medical licensees may want to comment on the possible changes. Participants supported the idea of encouraging cooperation to correct deficiencies by increasing the flexibility not to cite licensees if they are making corrections.
NRC staff also indicated that the final Part 35 rule would require revisions to NRC's enforcement policy found in NUREG 1600, Rev.1," General Statement of Policy and Procedures for NRC Enforcement Actions. The Part 35 Working Group will be reviewing and revising that policy as it pertains to the final rule. The inspection program and inspector qualifications also will be reviewed, including consideration of whether inspection is needed in certain circumstances, and whether, if needed, the inspection frequency for some medical licensees could be extended.
- 5. Emerging Technologies NRC staff explained that the intent of the emerging technologies section (Section 35.1000) in the proposed rule was to make the rule more flexible, since the critical radiation safety issues to be considered will evolve with the technology. Therefore, the proposed rule requires that additional information be provided at the time oflicense application. Three questions on this topic are, first, how to determine when a technology is no longer emerging. Second, to what extent should NRC use the same criteria to review all emerging technologies, even when it is revising license-specific materials? Third, is taking an existing approach and applying it in a new way or to a new location appropriately treated as an emerging technology? Issues of this type are raised by current developments in intervascular brachytherapy.
A participant representing the American College of Radiation Oncology expressed some doubt about whether there should be a separate section in the regulations on emerging technologies, pointing to gamma radiosurgery developments in the 1980's and 1990's, in which the American Society of Therapeutic Radiology and Oncology and the American Association of Radiological Surgeons each set up a task force to define standards for radiosurgery. The result was well-defined consensus standards for treatment as well as training.
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7 A participant representing the American College of Cardiology (ACC) presented two argum why vascular brachytherapy was still in the investigational stage and therefore an emergin the technology, particularly stent technology, is fairly new, and its application to cardiology is new There are many different forms of therapy currently being investigated. A second participant stre that the devices used vary greatly in dose level and type of radiation, and the alternative that will j ultimately prove to be best is still unknown. If the ultimate choice is a low-risk radiation source, more; practical and cost-effective methods of regulation may be preferable to the current requirements in t proposed rule. In particular, the cardiologist board certiGcation examination now addresses radiation protection and safety, so standards for training ofinterventional cardiologists already exist. A member !
of the audience representing the ACC also argued for categorization as an emerging technology.l Another participant, however, urged that nuclear cardiology is very widely applied in the diagnosis and management of thousands of patients with heart disease and is not an emerging l i
technology. The issue, in his opinion, is the 1,200 hour0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> .equirement to become an authorized user for j
nuclear cardiology. The current requirement is excessive, and can only be satisfied through speciali programs outside of the piofessional societies that are not very well overseen, or within formal training!
in radiology and nuclear medicine, where they are difficult to obtain. The American Society of Nuclea t
Cardiology, as well as the ACC, are well qualiGed to oversee or deliver the required training.
- i Participants discussed emerging technologies from the standpoint of how intervascular cardiology should be regulated, if the same radiation sources or the same biological effects, and therefore l-
! the same radiation safety hazards, are involved, then the techniques should not be considered emei Other participants suggested that the analogy ofintervascular cardiology with gamma radiosurgery wa i
appropriate, because it required coordination and cooperation of several societies, and this need was a criterion for an emerging technology. Another participant suggested that gamma radiosurgery was a denned technology and technique. In contrast, intervascular brachytherapy has not reached the point of determining the correct technology. Another participant argued, first, that the biology of the effect of '
i radiation also needs to be better understood before intervascular brachytherapy ceases to be an eme technology and second that because it is so intricately intertwined with interventional cardiology, angioplasty, it cannot be considered an extension of a previously existing brachytherapy technology to a new organ system.
An Agreement State participant argued that the key is to have a reasonable regulatory scheme to address new technologies, and that mechanism is FDA procedures for regulating research and determining when the research stage has been completed. Both NRC and Agreement States need to obtain information about ongoing research in advance of the point when the processes are licensed.
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Another participant suggested that the criterion for an emerging technology is whether the risk of the technology has been exactly defined. Once the risk is clear, the degree of regulation necessary can be determined.
NRC staff explained that medical research is covered by Section 35.6 of the proposed rule, while an emerging technology would be covered under Section 35.1000. Under Section 35.1000, NRC would seek information about the procedures, as well as necessary training and experience requirements for licensing this type of use. The Advisory Committee on the Medical Uses ofisotopes would be consulted on whether the radiation safety aspects of the use of the material had been adequately covered.
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- 6. Training and Experience NRC staff opened the discussion by explaining that the proposed rule addresses training and experience by focusing on radiation safety and requiring a structured educational program consisting of both didactic (i.e., radiation biology, nuclear physics, radiation protection, etc.) and practical training.
I Competency would be veri 0ed through an examination. The proposed rule contains two pathways to become an authorized user: certiGcation by a board approved by NRC; or training in radiation safety, j
passage of an examination in radiation safety, and preceptor certi0 cation. Two groups, endocrinologists and strontium-90 eye applicators, would no longer have standalone training and experience requirements, but would instead be incorporated into 35.300 and 35.400 requirements, respectively. Under 35.400 and 35.600, clinical competency was considered so closely interrelated with radiation safety that the current requirements were maintained with minor modincatiorn One participant reported that the American College of Nuclear Physicians thought that the current requirements should not be changed. The Society of Nuclear Medicine believed that demonstrated competence was more important than the number of hours of training and therefore the number of hours could be reduced but an examination was necessary. Another participant argued that the safety record of endocrinology has been good, and that the requirements in the current rule should be maintained. A cardiologist noted that because of the emerging nature ofintervascular brachytherapy the training and experience requirements cannot yet be de6ned. Another participant representing the American College of Cardiology and the American Society of Nuclear Cardiologists noted their support for the proposed approach for diagnostic uses of radiopharmaceuticais. These organizations are willing to revise their examinations to address radiation safety in the manner expected by the proposed new requirements. Another panicipant argued that professional organizations should be allowed to be accrediting organizations and give the examination, but other training organizations, operating under what are widely considered less rigorous standards, should not be accepted as adequate training.
An Agreement State representative questioned whether NRC or Agreement States would approve certifying organizations, and noted that continuing education requirements were also important. NRC staff explained that the current position is that an organization seeking approval could go to either the State or NRC for approval.
A participant raised the issue of what training and experience requirements should be speciGed for an emerging technology. In response, it was suggested that whether or not the technology is emerging, an individual should be competent to handle material safely. This competency should be veriGed by examination. A cardiologist participant stated that some time before the FDA approves a technology or device, a group of experts should determine the appropriate criteria for training and expeiience.
A participant noted that testing, rather than a specified number of hours of training, was a more accurate measure of competence. Another participant, speaking for the Society of Nuclear Medicine,
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stressed that the core curriculum of basic radiation sciences does not change regardless of the modality being used. Similarly, the practical experience required would be pertinent to all the areas of nuclear medicine. An examination, rather than an arbitrarily chosen number of hours of training, is key. Finally, documentation of radiation safety experience by a preceptor also is important as a means of ensuring practical experience, but criteria for who can serve as a preceptor are also important.
An Agreement State participant suggested that if hands-on experience dealing with radioactive materials is important, then training and experience requirements should also be included for
9 technologists, who handle the materials. Another participant urged NRC to consider including tests given by the Nuclear Medicine Technology Certification Board for technologists. One Agreement State participant strongly urged the adoption of requirements for technologists, while another Agreement State participant noted that a majority of the States do not have requirements for technologists. Another participant argued : hat competency for technologists should not be limited to safe handling of radioactive material. Finally, participants noted that radiation safety competency requirements for technologists would set a national standard, especially in States that have not adopted national licensure.
Participants stressed that the key issue was ensuring knowledge of basic radiation protection, and that both didactic and practical experience was necessary. However, it was noted that certifying organizations established requirements that have to be met before a candidate is eligible to take a certifying examination, and therefore such requirements would still exist even if they were not included in regulations. Another participant expressed concern that what was being defined as the minimum radiation safety training and experience might be misunderstood to equal clinical competence. Any certification or license issued by NRC should clearly note that it should not be construed as representing clinical competence. Both NRC and Agreement State staff agreed that both they and the professional societies and hospitals needed to make that point clear to the public.
- 7. Radiation Safety Committee NRC staff noted that the proposed rule eliminates the requirement for a Radiation Safety Committee (RSC), giving the licensee greater flexibility in how it manages its radiation safety program.
Under the proposed 35.24, a licensee could maintain the RSC structure, move the functions to another group, or have theR' adiation Safety Officer (RSO) report directly to the facility management. Certain key requirements were retained: management must approve a request for licensing actions and minor changes in the radiation protection program. Facilities must have administrative procedures for interdepartmental and interdisciplinary coordination, although the procedures can be tailored to the size and type of facility.
One participant argued that without a regulatory requirement, institutions might avoid the cost of having a coordinating body. Making the requirement less prescriptive in terms of membership was desirable, but the RSO should be a mandatory member. In addition, circumstances would determine whether it would be appropriate to require a RSC only for certain categories of uses (e.g.,35.400 or 35.600) but not for others (e.g.,35.100 or 35.200). A committee controlling the total institutional program could still be needed for an institution with both types of uses.
Another participant stressed that a committee of peers can have more influence on the internal enforcement of policies than an administrator. An RSC enhances facility staffinterrelation and intercommunication, and bridges gaps between medical and administrative staff. In addition, a State participant said that the State found it was easier to obtain action, working with the RSC in an institution rather than a single administrator, RSO, or authorized user. The position of the Health Physics Society in favor of retaining the RSC requirement was noted.
The experience of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) was described by another participant. Several years ago JCAHO adopted non-prescriptive standards for the safety committee, and eliminated requirements for membership, frequency of meetings, reports, and other similar prescriptive requirements. The JCAHO continued to require the function to be present, as a multidisciplinary group. However, JCAHO had learned that it was necessary to be very careful to communicate that certain functions had to be maintained. The JCAHO has maintained certain functions because it has received numerous contacts from persons who had misinterpreted the
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requirements, or whose management had concluded that the committee and its ftmetions could be eliminated.
If an RSC was required, one participant argued that it should include both the RSO and a member of management. Another participant from the Oncology Nursing Society, who believed the 4
society would support having an RSC, noted that the frequency of meetings could be left unspecined, since some might need monthly meetings and for others semiannual meetings would be sufficient.
- 8. Institutional Licensing A participant from a large State university with numerous campuses and licenses urged NRC to consider the adoption of an " institutional license." He believed such a license would be more efficient than several licenses for the component parts of the institution. For a large medical facility, a single uni 0ed licer.se would allow the development of a single policy, procedure, or protocol that would cover all operations, regardless of their physical location. Some institutions now are required to obtain as many as 10 different licenses.
NRC staff described broad scope licenses, such as the National Institutes of Health, and Master Materials Ucenses, which currently are used to address military services, such as the Air Force. Thus, mechanism.i do already exist that could be used in the appropriate circumstances in the manner sought by the partic: pants. However, NRC has limited use of Master Materials Licenses to Federal organizations.
Jurisdicinal problems could arise if organizations have facilities located in both NRC States and Agreemect States.
A participant noted that NRC-licensed VA hospitals and State-licensed universities sometimes work together, although because of the different licensing authorities it is difficult for them to completely integrate their operations. This participant urged NRC and Agreement States to consider transfers of authority so that such programs can be more fully integrated.
- 9. Accuracy of Dose Prescriptions
- A participant raised the issue of a practice followed in manual brachytherapy that might not satisfy the requirement that there be a written prescription prior to the procedure, or that the actual administration not differ by more than 20 percent from the prescribed administration. Specifically, in the course of surgery, a physician may determine that implantation of seeds is indicated to treat residual tumor tissue that cannot be removed. However, the number of seeds needed might not be determinable in advance, due to the irregular shape of the surface, although the strength of each seed would be known.
NRC staff explained that under both the current rule and the proposed rule such a situation would not necessarily be a misadministration or medical event. The rules require a written directive to be prepared in advance specifying the radionuclide, number of sources and source strength. However, after the implantation, the written directive could be revised to state the number of seeds used. Such a revision is allowable under the current rule and the proposed Section 35.40. NRC staff emphasized that such a revision would need to be made prior to the completion of the procedure. Another participant expressed concern that readjusting written directives could undermine the principle of using trigger events to identify programmatic problems.
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- 10. Medical Events i NRC staff outlined the reasons for the requirements pertaining to " medical events" in the
! proposed rule and indicated that the term " misadministration" was replaced by " medical event." The following items were noted for meeting participants by the NRC staff. The proposed rule also addiesse '
wrong treatment site and patient intervention, two issues not covered by the current rule, A dose threshold is included in the proposed rule for medical events. The dose threshold is the first criterion in) deciding if something is a medical event. The second criterion is whether the dose differs by a sp
' percentage from that specified in the written directive. The third is whether the event resulted from patient intervention. NRC staff requested comments, in particular, on what constitutes patient ,
intervention. NRC staff also noted that the proposed rule would eliminate " recordable events."
One participant supported the thresholds, both conceptually and at the levels stated in the proposed rule, which he found to be reasonably significant radiation exposures. However, that !
participant aise stressed the position of the Society of Nuclear Medicine that the rule is unnecessary diagnostic uses of radionuclides. Another participant stressed that dose is estimated, based on clinical experience and with a number of simplifying assumptions. Second, the difference in estimated dose should be tied to risk; and if the risk associated with the 20 percent difference from the written directive is subclinical, then there is no risk. Earlier in the discussion, a participant also expressed doubt that underdosages should be a matter ofconcern suitable to be addressed as a medical event. NRC staff explained that the goal of the proposed rule requirement is to identify events where there has been a significant deviation from what the physician directed, and to define medical event in a way that would apply to risk for all of the modalities included under Part 35.
A member of the audience suggested raising the threshold even higher to be similar to FDA requirements, because in his opinion events will still be reported to NRC that have no medical consequences. NRC staffexplained that consideration had been given to other thresholds. The thresholds selected were intended to provide awareness of potential problems, not to trigger enforcement actions, and to enable information to be provided other licensees about generic issues. An Agreement State participant stated that even if significantly lower thresholds are used, programmatic problems are revealed, therefore, lower rather than higher thresholds might lead to earlier correction of problems.
- 11. Agreement State Issues NRC staff provided information about the proposed levels of compatibility for the proposed rule, noting that they are described and explained in detail in the Federal Recister notice and in a chart that NRC will Jace on its web site. The upcoming All-Agreements State meeting in October will also discuss the topic.
f aticipants requested NRC to provide more detail on the rationale for assigning a particular compatibility designation for each section of the proposed rule. NRC staff explained that the designations were based on NRC's compatibility and adequacy policy. A participant from an Agreement State expressed concern about the liberal use of the health and safety (H and S) designation, citing Sections 35.70(b) and 35.63(a). NRC staff again proposed to provide the chart of section-by-section designations, i so that questions can more easily be identified, and noted that additional review of the designations was expected to occur.
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SUMMARY
OF PUBLIC MEETING ON PROPOSED REVISIONS TO 10 CFR PART 35
" MEDICAL USE OF BYPRODUCT MATERIAL" AND 1 THE NRC'S MEDICAL POLICY STATEMENT l l
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Kansas City, Missouri l September 16 and 17,1998 1
Prepared for Office of Nuclear Material Safety and Safeguards by ICF Incorporated under Contract NitC-04-95-065 October 12,1998
1 Invited Participants l 1
1 Robert Carretta, M.D.
Ralph P. Lieto, M.S.
Ronald Van Heerum, M.D. Mickey T. Clarke, CNMT Wally Ahluwalia, M.D.
Milton E. Williams Carlos R. Hamilton, Jr., M.D., F.A.C.E. Ashok Dhar Laurie Meyers Kathy Allen Ben D. McCallister, M.D., F.A.C.C. Tom Connelly Neil Eigler, M.D., F.A.C.C.
Barry Siegel, M.D.
Timothy Bateman, M.D., F.A.C.C.
Charles H. Rose David Diamond, M.D.
Cathy Haney Marge Therio Robinson Diane Flack I
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- 1. Risk NRC staff explained how the proposed rule had been made more risk-informed. First, the risks associated with the use of radioactive material in medicine are considered diagnostic nuclear medicine, and therefore less prescriptive requirements were put into the
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proposed rule. Therapeutic medical uses are considered to be higher risk areas, and the prop regulations for those uses have greater detail, more specificity, and are somewhat more prescriptive. Factors that were considered in assessing risk included the use of the material, the likelihood of an event, the consequences if an event does occur, and the impacts on three i
populations: patients, occupational workers, and the public. Misadministration data were '
considered,in the context of the Part 35 rules that were in effect when the misadministration occured. Finally, the issue of perceived risk also was considered, including NRC's need to repo to Congress on Abnormal Occurrences. One overall goal of the regulatory revisions was to establish requirements that would identify events before they have biological consequences.
Participants iesponded by noting, first, that although NRC had looked at relative risk, a quantitative probabilistic risk assessment had not been done. Second, a risk assessment comparing the activities regulated under Part 35 relative to the rest of medicine, and evaluating whether the NRC program is over-weighted relative to the risk that the use of byproduct material poses to patients, the public, and workers, in comparison with other things that occur in medicine, also was needed.
One panicipant, who stressed that the magnitude of risks from therapeutic applications is substantially greater than from diagnostic and that there are also substantial differences in risk within the therapeutic area, suggested that data should show that some rules (e.g., dose calibrator requirements and some brachytherapy requirements) are unnecessarily prescriptive even for some therapeutic uses. Another participant, addressing the use of radiation to treat restenosis, argued that the radiation risk may be low compared to the medical risk of alternative procedures, or of delays in carying out procedures because of regulatory requirements. A participant stressed that regulatory requirements, including training requirements, should be specific for the isotope that is being used and the circumstances in which it is used. Several participants discussed the necessary balance between training requirements, standards of practice, radiation risk, and medical risk, and the extent to which regulatory requirements may affect that balance or in some cases deter the dissemination of particular procedures. In that context, a participant noted that modalities using byproduct material may be more intensively regulated than other modalities using ionizing radiation. One participant argued strenuously that regulation of byproduct material is overweighted compared to non-byproduct material, but conceded that the issue would need to be addressed through Commission action (reinterpreting its discretion under the Atomic Energy Act) or legislation rather than through revisions to Part 35.
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One participant offered cost data prepared in support ofIlealth Care Financing Administration reimbursement suggesting that the additional costs of handling radionuclide
' materials predominantly attributable to NRC regulation amount to $30 to $40 per patient, including costs for staff, equipment, space, and recordkeeping. These costs can be a deterrent to
2-the growth of the technology. Another participant stressed that certain costs of radiation safety practices are likely to occur whether or not they are required by regulation. and that the costs cited are relatively small in relation to an average of $750 to $1,500 reimbursement per procedure.
Participants suggested that an example of an unnecessary Federal regulatory requirement was the dose calibrator standards. One said that even though the proposed rule relaxed existing requirements, they continued to be more prescriptive than necessary, given the level of risk and the likelihood that physicians would follow reasonable practice standards even without the regulation. Another argued that the proposed rule specified tests and test frequencies that are not appropriate for current technology, and noted that although the rule addresses dose calibrators it does not address counting equipment for bioassays on wall counters. NRC staff responded that manufacturers had been consulted about appropriate tests, but additional information would be helpful, and that the proposed rule had been drafted to address " instrumentation" to avoid an exclusive focus on dose calibrators. Another participant suggested the supervision requirement as another example of an unnecessary requirement. Noting that the requirement was included on the basis of misadministration data, the participant argued that the absence of such data for diagnostic nuclear medicine suggested that the requirement was not needed in that area. A rationale for why the requirement increased safety in nuclear medicine was needed. A member of the audience stressed the importance, in some parts of the country, of ensuring that regulatory requirements did not limit access to certain procedures.
- 2. Use of Accreditation Programs and Professional Standards The possibility of using accreditation programs as a substitute for NRC inspections was mtroduced by two participants, who reported on a recent meeting facilitated by the American l College of Radiology (ACR), including representatives from the Society of Nuclear Medicine (SNM), the American College of Nuclear Physicians (ACNP), the Intersocietal Commission for Nuclear Laboratory Accreditation (ICNLA), the US Hospital Engineering Association, and the ACR, to consider the essentials of an accreditation program and how it might be used. The group identified the broad framework for a voluntary accreditation program for the radiation safety aspects of nuclear laboratories. The presentation outlined the essentials as follows: a voluntary program of peer review; process improvement as part of accreditation; both paper and on-site inspection; evaluation of NRC performance requirements, including radiation dose limits, appropriate policies and procedures, and personnel qualifications as part of the accreditation; approval for a three-year period; and a modular approach in which one or more aspects of the practice would be accredited at a time. The program would need to have procedures to avoid I conflict ofinterest, an appeals process, and clear schedules for correcting deficiencies. Such a
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i program was expected to reduce costs for accrediting facilities; provide a peer evaluation based on standards of care, and provide flexibility and alternatives for achieving regulatory goals.
l NRC could assume that the accredited bodies are meeting or exceeding agency requirements;
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inspection frequency could decrease; and NRC could focus on radiation safety improvements.
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Participants reported that the group had identified three majer organizations that are l
l currently involved in accreditation: the established ACNP program, and programs of the ACR and ICNLA that are both in pilot testing.
The participants responded to questions from NRC staffconcerning the ACNP accreditation program by explaining that it is a 3-year voluntary peer-reviewed program that reviews all aspects ofradiation safety. They stressed that if NRC were to change its inspectio program so that if a facility was accredited by such an organization NRC either would not inspec or would inspect less frequently, the organizations would need to ensure that all the key points that NRC considered necessary would be covered in the accreditation process. The issue of the level of compatibility for Agreement States would have to be addressed. In addition, the accreditation programs currently are voluntary. Therefore, considerable interaction with NRC would be needed to ensure that NRC could recognize accreditation in terms of deferral of inspection. In response to a question from an Agreement State representative, a participant wh had done approximately 40 inspections under the ACNP accreditation program stated that there was a good parallel between that process and State or NRC regulation and inspection.
Participants also noted that although the program looks for evidence oflicensing and certification, and of contining medical education, it does not assess education directly. The !
feedback provided as part of the accreditation also serves an educational function. One l participant stressed that the detailed results of the accreditation are confidential, although info'rmation about whether the program passed is public. An organization performing an '
accreditation review now would not provide a list to NRC or a State ofissues or violations that it finds when it carries out the accreditation. NRC stafTnoted that the suggestion had many positive features but problems with access to files by NRC and the States might be an important issue. At a minimum, a report of violations identified in the process would be needed. Funding of the program, including issues of NRC fees, had not been considered. Currently, a very small percentage of facilities participate in the existing accreditation program, and the two pilot programs also are small. A key lesson learned is that the program should be developed in a '
multidisciplinary, inclusive, and open manner by representatives of all of the professional specialities that might be involved or affected.
A participant from the American Society of Nuclear Cardiology (ASNC) and the American College of Cardiology (ACC) noted that those groups had not been participants, and asked whether NRC would set minimum standards for the accrediting bodies or the bodies themselves would establish the standards. Although the issue was still under consideration, one participant suggested that the most sensible approach would be for the professionals in the organizations to determine the standards. Whether Part 35 requirements would form the basis of the requirements also was not clear. How this system would address emerging technologies would also need to be further evaluated. Finally, the programs would probably develop a modular approach that would meet the NRC requirements if groups did not want to go through the entire accreditation process.
An Agreement State participant stressed that such a program would have to provide assurance that any problem areas would be resolved in an efTective and timely manner and that 1
4 generic problems, as well as good practices, would be identified. Another Agreement State participant noted that if only a part of the facility was accredited in a modular approach, the State would check the entire facility and not ignore the accredited portion. In addition, if the program is voluntary, detailed regulatory requirements would be necessary to cover the facilities that would not go through the voluntary accreditations. Some States will be very reluctant to relinquish inspections. A participant noted that State and Federal inspectors have authorities and regulatory responsibilities that are not afforded to non-governmental personnel, including the authority to cause immediate compliance, and wondered if the professional societies would be given authority to implement regulations. Several participants addressed the differences between contracting out inspection activities and adopting a policy that recognizes accreditation as an alternative to inspection.
The accreditation process, and how it would be used, could be worked out separately but in parallel with the Part 35 regulatory revisions, according to several participants. However, another participant questioned whether professional bodies could continue to revise standards, if the process was not integrated into Part 35, or whether the Part 35 requirements would become the standard by default, with the organizations adopting NRC's requirements. Some members questioned whether the timetable for revisions to Part 35 would allow full development of the concept, and whether it could proceed in parallel with the Part 35 revisions either through rulemaking or policy determinations. NRC staff explained that because it would involve a significant change in the inspection program it would need to be reviewed and approved.
Therefore, the proposed rule should be evaluated from the standpoint of the current inspection and enforcement policies.
- 3. Inspection and Enforcernent NRC staff from the Oflice of Enforcement described the development of the enforcement policy (NUREG 1600) and explained how a performance-based rule like the proposed revisions to Part 35 would be enforced. The two key characteristics of such a rule are that (1) there is a requirement for a licensee to develop and implement procedures to achieve a stated goal, and (2)
NRC will issue guidance on what it finds to be adequate procedures. On a routine inspection the inspector might not review the procedures, but would look at implementation of those procedures, including records of the licensee's own audits to ensure that the licensee is finding and correcting its own problems. Compliance with non-performance based portions of the rule also would be reviewed. Reactive inspections could occur following a reportable event, to ensure that the licensee had procedures and to determine if the procedures were followed.
Finally, when the licensee has identified and corrected a violation, new NRC guidance will provide that for Severity Level IV violations a Notice of Violation normally will not be issued.
NRC staff noted that the proposed rule involves a change in licensing philosopy as well as inspection philosophy. Procedures will not be reviewed in the licensing phase, and inspectors will be reviewing activities and operations, not written procedures, unless it appears a problem is related to missing or inadequate procedures. That is, inspectors will not review procedures at the time ofinspection unless they have cause to do a review. NRC has developed or will be
5-developing, guidance containing model procedures, revisions to the enforcement policy, and inspection manuals to ensure they are suitable for the performance-based approach. 4 i
- An Agreement State participant suggested that review of procedures in licensing could be useful in avoiding problems, and noted that if neither licensing nor inspection stafflook at the procedures unless a problem occurs then many procedures will never be reviewed Another participant suggested that the proposed rule's stress on procedures, rather than what is bei sought to be accomplished through the procedures, might be a mistake in emphasis. Another participant, however, explained that requiring procedures in place that provide high confidence will allow for the fact that in some cases human error may occur even if there is nothing w 1 with the procedures. This gives the NRC stafTmore discretion to determine the situation and its l causes, and not be forced to issue an automatic citation. For example, a rule that requires a physician to deliver the correct dose to the correct patient provides substantially no enforcement discretion, while a rule tnat requires the licensee to develop and implement a procedure to provide high confidence that the correct dose is delivered allows greater flexibility in assessin its implementation.
l A participant expressed concern that prescriptive contents of previous regulatory guides might have been incorporated into the new guidance (NUREG 1556) prepared simultaneousl with the proposed rule. NRC stafrexplained that any requirements considered necessary to retain had been moved from the NUREG to the proposed rule, so that the NUREG did not add any requirements that were not in the proposed rule. The NUREG is intended to provide model l procedures but not additional prescriptive requirements, and will not be incorporated by tie-down clauses in licenses. Anything that was considered absolutely important and needed for safe operation was put into the rule, as well as retained in the procedure, but NRC would cite against the rule and not the procedure.
In response to questions about whether procedures in the guidance would be treated as i
starting points, one participant noted that in a performance-based system a licensee could '
develop and implement procedures that are less rigorous than the procedures in NUREG 1556, but if the licensee never experienced a problem related to those procedures, it would be in compliance.
The same participant also expressed concern about the meaning of {35.10, which provides that requirements currently contained in licenses will be retained until the next license renewal or amendment. With license renewal dates being extended, a license amendment would be needed to eliminate certain restrictive or prescriptive requirements. This could pose a cost and implementation burden, and might also lead to issues ofinspection enforcement. NRC staff explained that the section was patterned on a similar provision in Part 20, and was intended to address situations in which licensees had restrictive license conditions because of their operations. The intent, for example, was not to continue to enforce parts of the quality management rule that had otherwise been eliminated from the regulations.
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- 4. Agreement State Issues NRC stafTexplained that two members from the States were on the regulatory development working group, and that the proposed rule had been carefully considered to ensure that it did not create problems for Agreement States. After the proposed rule was drafted, each section was assigned an adequacy and compatibility level, based on policy set by the Commission. Most of the rule is assigned Category D, which indicates that the rule does not need to be adopted for compatibility. Some sections, particularly involving training and experience, surveys, and equipment calibration requirements, are Category C, which means that State regulations should be essentially the same as the NRC rules. A few sections are designated ll&S, which means that the States must adopt that requirement because it is significant to health and safety, and affects the adequacy of the program. The State participants on the working group emphasized that certain Agreement States will not adopt some of the proposed regulatory changes that are designated Category D. In addition, some States may conclude that they want to retain their current requirements, which may be more restrictive than those of NRC.
Section 35.75 of the rule was discussed from the standpoint ofits impact on the States.
Agreement State participants noted that States have experienced costs from responding to i
landfills that detect I-131 or other radioactive materials from household waste generated by released patients, and are concerned that more numerous patient releases could increase this problem, or lead to other actual or perceived public health concerns. However, as NRC staff pointed out, the changes to the patient release criteria had already gone into effect when the Part 35 revisions began, and were not revised as part of the proposed rule. Section 35.75(a) was designated as Category C, based on application of the criteria established by the Office of State Programs, with the detennining factor being the 500 mrem dose limit it contains. The balance of the section is Category D.
l A participant supported the use of risk as a compatibility criterion. One Agreement State participant reported that the risk-based approach to reducing the prescriptive nature of the rule for diagnostic uses appeared reasonable to that State program, although the State might want to review procedures in advance to ensure that they are prepared in a timely way.
Participants were reminded that the All-Agreements States meeting in Manchester, New Hampshire in October will include a session, in which NRC stafTwill participate, focusing on Part 35 and examining the compatibility and adequacy designations.
- 5. Dose Calibrators NRC staff explained that the dose calibrator requirements in the proposed rule, found in 35.60 to 35.62, are intended to be less prescriptive than the current rule In particular, first, a licensee is not required to possess and use a dose calibrator (more precisely, an instrument to i
l measure the activity ofdosages)ifit uses only unit dosages. The proposed rule does require National Institute of Standards and Technology (NIST) traceability of sources that are used to calibrate the dose calibrator, and specifies the energy range of sources, two items that formerly
were included in guidance. The draft guidance contains model procedures for dose calibrator calibration.
One participant noted that a point in favor of requiring dose calibrators is that they provide a quick and relatively easy method of determining whether a radiopharmaceutical that is being administered is the correct radioisotope. Experience in a least one Agreement State suggests that if they are not required, licensees will not purchase them if they can obtain radiopharmaceuticals from a radiopharmacy.
Participants addressed several technical points conceming the proposed rule. One participant noted that a requirement ofphoton energy between 100 and 500 kev would exclude cesium, one of the most common radioisotopes used for accuracy testing, with 662 kev, and recommended that the range be increased from 100 to 700 kev. Another participant noted that 35.60(b)(1) of the proposed rule calls for a test for geometry dependence following repair, while the current rule requires such a test only once in the lifetime of the instrument. A similar requirement is in 35.62 of the proposed rule. Additional review will be given to this issue.
A participant suggested that, with respect to f { 35.60,35.62, and 35.63, although NRC is considering administration of diagnostic radiopharmaceuticals to be low risk activities, an inspectable paper trail continues to be needed to show that the dosage was the dosage prescribed, something that is not required in medicine for other prescription drugs. This participant believed that even if NRC removed the regulatory requirement for a dose calibrator and for measuring diagnostic dosages, ACR and SNM standards would continue to identify them as an important safety check. However, a different set ofrecommendations might be developed concerning how to evaluate whether the dose calibrator is perfonning reliably and how to chart the dosage. An important question is whether the paper trail and cost associated with it is necessary to make the behavior inspectable.
In support, another participant stressed that the risk of diagnostic dosages is already low, that pharmacies that prepare unit dosages are licensed and regulated, and therefore the standards for unit dosages should not be different from standards for any other drug that is used. Two other participants concurred. A third participant asked if NRC had assessed the costs of purchasing a dose calibrator against the benefits ofidentifying difTerent dosages. The same participant advocated reliance on the recommendations of manufacturers or other groups such as the American Association of Physicists in Medicine (AAPM) on the testing requirements for dose calibrators. Another participant asked if all of the specified testing was necessary with newer technologies and whether licensees could submit alternatives. (NRC stafTresponded that i
licensees could propose alternatives to any part of the rule.) Different types oflicensees will have different levels of need for a dose calibrator, argued another participant, who believed that the requirement created a high cost to risk factor for licensees using low dosages.
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- 6. Medical Policy Statement NRC stafflisted three goals for the revisions to the Medical Policy Statement (MPS): to provide for the radiation safety of workers and the public; not to intrude into medicaljudgment; and to focus the regulations on assuring that the use of the radionuclides is in accordance with the physician's directions.
The key changes in the revised MPS substitute "not intrude into medicaljudgments" for
" minimize intrusion;" bring in the concept of assuring that the physician's directions are followed; and specify that NRC will consider, rather than rely on, industry policy and standards when developing a rule.
1 In reviewing the text of the MPS, participants did not express any concerns about the first or second statements in the revised MPS. One participant did question the need for the third statement, but was satisfied that it was a boundary condition for the NRC's regulation. A participant criticized the fourth statement for failing to acknowledge that industry standards may be adequate without NRC regulation in some areas. In addition, this participant suggested that based on the language in the third statement concerning risk to patients, certain requirements pertaining to diagnost i c uses in the proposed rule are unnecessary, and that industry standards could be relied upon. Another participant agreed that the proposed revision to the MPS was more restrictive, because it no longer suggested that NRC will regulate where justified when voluntary standards are inadequate. The phrase "will consider" might be need to be replaced, because it no longer suggests that NRC will make an aflirmative finding that industry standards are inadequate before regulating.
NRC stafTexplained that at present NRC may be regulating in areas in which industry standards are adequate. Therefore, the proposed MPS more accurately reflects current practice.
In addition, while key items from an industry standard might be appropriate for inclusion in regulations, other components of the standard might not be at the level of need to be incorporated into a rule. Therefore "will consider" retains flexibility. That was the approach taken in the revisions to the rules under (( 35.400 and 35.600, where references to protocols for calibration of therapy equipment are included in the rule along with other more prescriptive requirements.
A participant noted that rather than reflecting current practice it might be more desirable to change it.
A participant suggested that statement four of the MPS could allow NRC to consider possible accreditation approaches in the future. Such an approach, however, could also have been considered under the former MPS, according to another participant.
NRC stafT noted that all ru'emakings in the medical area contain statements at the proposed and final rule stages stating whether or not the stafTbelieves the rule is consistent with the MPS. The Part 35 proposed rule was considered in light of both the current and the proposed MPS and found to be consistent.
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- 7. Training and Experience l
NRC staff described the training and experience requirements in the proposed rule. The l
requirements focus on radiation safety; consider the risk associated with different modalities; and require individuals to complete a structured educational program consisting of both didactic and practical training. Competency is verified through an examination, to be given either by a certifying organization or by a testing organization approved by NRC. In the second case, the candidate would also need to obtain a preceptor statement. The examinations would be focused strictly on radiation safety, not clinical competence. The bases for the difTerent hours requirements for the didactic and practical training also were described. The proposed rule does not specify requirements for emerging technologies, based on the understanding that training and experience requirements could be different depending on whether it is a high or low risk. l As background for a discussion of training and experience requirements as they relate to what might be an emerging technology, a participant described developments in the area of )
intravascular radiotherapy. A particular issue arising from the state of this technology, in the participant's view, is the difliculty of developing appropriate regulatory guidelines for a modality in which the risk is not yet defined. In addition, some applications may be new applications of an existing technology, while others are new technology. There may even be significant ditTerences between components of the new technologies (e.g., coated stents, bombarded stents, or implanted stents).
Participants from the ACC described the medical risk associated with alternative procedures for addressing coronary artery disease and explained the possible advantages of intravascular radiation, current studies of this technology, and efforts underway by the ACC and the American Board ofInternal Medicine to develop a subspecialty board for interventional cardiology that will administer its first certification examinations in November 1999. The ACC considers intravascular coronary therapy an emerging technology, and therefore believes it would be appropriate to address it under s35.1000 of the proposed rule. Training and experience requirements would then be developed on a risk-based approach with the NRC Part 35 should, in their view, distinguish intravascular coronary therapy more distinctly from other types of brachytherapy that are used in radiation oncology.
Another participant commented on criteria to guide the NRC on whether s35.1000 should apply to a particular technology. In his opinion, one criterion might be whether the training and experience issues involved are substantially ditTerent from those that exist under other sections of the rules, such as ss 35A00 or 35.600. In the course of an extended discussion ofintravascular coronary therapy, and whether it should be considered an emerging technology or an application similar to existing radiation oncology modalities, several other potential criteria , primarily clinical in nature, were suggested: the anatomy and physiology involved; the affected tissue and tissue volume; the adjunctive pharmacology; the area of the hospital involved; procedures for
! management of complications; and potential for emergency use of the procedure. Other
- participants suggested that clinical issues should not be considered by NRC. Instead, NRC should concentrate on radiation safety issues in making the determination. Some participants
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also noted that the dose rates used in the procedure were significantly higher than those involved j in radiation oncology, and other dosimetry issues (e.g., micro-millimeter dosimetry and j intraprocedural decision making about dosimetry) also were identified. Other participants, as l well as members of the audience, endorsed the idea of placing a section in the proposed rule dealing with emerging technologies, although precisely how it will be implemented remained an l issue.
Turning to other issues associated with the proposed training and experience requirements, two participants presented a position paper of the American Association of !
Clinical Endocrinologists opposing the changes in the proposed rule pertaining to the training I and experience requirements for the use of radioactive iodine in the treatment of hyperthyroidism and thyroid cancer. The specific issue of concem was the amount of training required. The proposal for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> ofdidactic and laboratory training should be reduced to 40, according to i these participants, who believed it was reasonable to specify a minimum number of cases. Other l
participants expressed concem about reducing the hours for didactic training, because the section '
involved, @35.390, pertains to a number of difTerent types of therapeutic isotopes, and the number ofisotopes and procedures covered by the section is expected to increase. A participant
! noted that if the requirements for I-131 in the management of hyperthyroidism and thyroid cancer were isolated from the rest of the section, that would essentially replicate the current rule.
Participants discussed whether any parts of the required training could take place concurrently and how substantially to rely on the preceptor to determine if the training and experience was sufficient. In addition, participants inquired whether NRC would consider licensing individuals by the specific therapeutic uses that they are asking to get approved; and, if so, if someone seeking licensing for several therapeutic uses would have to demonstrate experience with five cases for each of the requested uses. A participant urged persons or groups who believe that the I
numbers of didactic training hours are not on target to provide a curriculum and specify the l number of classroom and laboratory hours that are needed. Another participant urged NRC to concentrate on the curriculum for basic radiation safety, rather than numbers of hours, and to place considerable emphasis on the examination.
On the subject of training and experience requirements for the Radiation Safety Officer (RSO), one participant argued that requiring one year of full-time radiation safety experience under the supervision of an RSO was not sufficient. Participants also questioned whether Part 35 should allow an authorized user to be granted status as an RSO without additional requirements.
I particularly in situations where therapeutic uses or multiple departments are involved. One l participant noted that elimination of the Radiation Safety Committee requirement would make it very important that RSO's are competent.
l NRC stafTstressed that the proposed rule also requires the authorized user to have experience with radiation safety aspects of similar types of byproduct material for which the individual has RSO responsibilities. Participants discussed, in terms of medical institutions of difTerent sizes and types, whether an authorized user would be likely to be selected as an RSO based on only meeting authorized user qualifications. Participants also examined whether an j authorized user for certain categories of procedures could be selected as RSO only for those l
4 types of procedures, and problems ofimplementation that might occur. A participant suggest the possibility of specifying different hours of training requirements for RSOs for different levels or sizes of facilities. Another participant suggested that because the RSO has responsibilities th are different from and greater than the authorized user, a competency examination could be required for RSO.
A participant from the liealth Physics Society suggested that NRC should consider accepting as certifying organizations those organizations that are approved under the current regulations, without requiring them to submit new materials. The group also listed groups that 1
might be likely to seek to do certification, and that could be invited to participate in a l forthcoming public meeting. A participant brought up the status of certain specialties or sub-specialities for which there are currently no boards for special certificates of expertise. NRC was encouraged to refer to certifying bodies rather than boards.
- 8. Notification Following a Medical Event (Patient Notification)
NRC staff summarized the current and proposed rules and explained the basis for the Commission's selection of the proposed alternative. A requirement that the NRC, the referring physician, and the patient all be notified reaffirms the Commission's previous position that patients have a right to know information about themselves; enables patients to make timely decisions in consultation with the physician about remedial and prospective medical care; and maintains consistency with FDA requirements in the mammography area on patient notification.
i A participant responded that patient notification does not need to be a Federal '
requirement, because the medical standards of care and ethical guidelines already advocate such notification and in addition it is a good means of managing the risk of future liability. This participant supported, at a minimum, removal of the requirement to explain that the notice was !
required by NRC and that the patient could obtain a copy of the report to NRC. liowever, requiring written notification raises the patient's consciousness of the seriousness of the event more than is necessary in n.any instances, according to the same participant. Therefore, elimination of the patient notification requirement, elimination of the written component of the requirement, or raising the threshold for patient notification were all desirable alternatives. At the same time, medical event reporting to NRC is important so that the NRC can be a national clearinghouse for information about events that are below clinical significance.
Another participant noted that reporting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> may convey an impression of greater concern than is warranted. A similar problem is created by the requirement that the
" responsible relative or guardian" be notified, since in many cases that person may tell the patient even if the physician'sjudgment is that notification of the patient could be harmful. In addition, the relative may be only distantly related. Informing a distant relative could violate the patient's confidentiality. The participant who raised these issues suggested that the rule should be revised to specify relative with medical power of attorney.
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1 Another participant noted that providing a written report to a patient has no precedent in i medicine. Generally, the practice would be to discuss with the patient, particularly if the risk of l harm was very small. l NRC stafrexplained that the Commission had determined that notification to the patient, the patient's referring physician, and the NRC should continue to be required. Therefore, the ,
option of eliminating the written notification requirement was very unlikely to be adopted. A l participant urged NRC to provide any available information about whether or not failure to notify created a problem. However, compliance with the notification requirements, coupled with the fact that the rule has been in efTect for a considerable time, means that substantial information is probably not available. The Commission was provided data, including analyses of the issue from medicaljournals and the press. One participant suggested that Agreement State data might be useful for determining if, absent the notification requirement, significant harm is being done to patients. Another participant suggested that notification might be required only after a determination that harm might otherwise occur.
- 9. Radiation Safety Committee NRC stafrexplained that in order to provide greater flexibility to licensees in the management of their radiation safety programs, the prescriptive requirements concerning the Radiation Safety Committee (RSC) had been eliminated. Section 35.24," Authority and responsibility for the radiadon protection program" replaces the RSC requirements. Licensees are required to develop administrative procedures for inter-departmental and inter-disciplinary coordination. Certain key elements that had been the responsibility of the RSC were retained in the proposed rule: licensee management must approve requests for licensing actions, such as appointing authorized users, nuclear pharmacists, radiation safety officers, and medical physicists; and management must sign minor changes to the radiation protection program. The impact of the elimination of the RSC requirement on radiation protection programs, the role of the Radiation Safety Ollicer, particularly in a reconstituted RSC, and the level of detail in requirements for an RSC-like organization are questions on which NRC is seeking further information.
A participant representing the AAPM stressed that it believes the RSC should be required in the rules when there are therapeutic multi-department activities involving radioactive materials. The proposed rule would lead to d.e radiation protection program being composed and managed by a manager who is not knowledgeable in radiation safety activities and who might rely very heavily on the RSO. The effectiveness of the RSO could be compromised, however, unless issues and policies are reviewed and supported by a review committee of peers from different departments. Otherwise, the RSO may be viewed as a representative of only one
' department, and fail to achieve the necessary level of cooperation. This participant also argued that existing safety committees will be too busy with their other activities to assume additional responsibilities for radiation safety.
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A participant from an Agreement State also representing the llealth Physics Society agreed. As more hospitals merge, RSCs can help maintain consistency between programs.
Another Agreement State participant noted that the RSC now reviews the training and experienc of an individual before that person is added to the license as an authorized user. Furthermore, the RSC oversecs shared resources, including equipment. All parts of the institution might not be aware of certain actions if only an administrator reviews and signs off on them. Institutions may use RSCs to address the use ofionizing radiation or radiation-producing machines in addition to issues arising from the use of byproduct material.
A participant from the ACNP and the SNM reported that both of those organizations support the proposal. They believe that the flexibility to implement an approach that is appropriate for the facility is desirable, and do not believe that elimination of the prescriptive RSC requirements will cause management to knowingly not address potentially harmful situations.
Another participant also supported the flexibility in the proposed rule concerning the membership and other characteristics of an interdisciplinary committee. lie also stressed that differences among facilities affect their need for coordinating groups.
RSCs can provide expert review for research and investigational uses, one participant noted. Although a majority oflicensees are likely to be small practices doing diagnostic imaging or laboratory activities that do not require a RSC, institutions with multi-department or multi-disciplinary involvement do need a coordinating committee. This participant was not certain that large institutions would perceive the need for such a function without a regulatory requirement, and believed that the RSO's function would become much more difficult without a committee.
l A participant noted that some clinics, which may be limited to diagnostic uses, can be I three or four times larger than the nuclear medicine departments of many hospitals, but are not required to form a RSC. Significant radiation safety problems have not occured in these situations. In addition, the delegation of authority to a RSO should be broad enough to allow the RSO to set up a RSC ifit is needed. l
- 10. Reportable Events l NRC staff summarized the requirements of the proposed rule pertaining to reportable events. A participant expressed apprehension about the reporting thresholds, noting that one intravascular source in a few seconds could deliver a dose in excess of the 50 rem threshold. l Similarly, the basis for the 500 millirem threshold pertaining to unintended doses to embryos, fetuses, or the nursing child was not clear to the participant, and appeared to be too low, since the National Council on Radiation Protection and the ACR have indicated that doses below 5.000 millirems for diagnostic X-ray procedures are a negligible hazard, and genetic counseling personnel identify radiation risk at even higher levels. In addition, reports might not be required ifin an immediately previous inquiry the patient had informed the physician that she was not
! pregnant or nursing.
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. i A participant from the ACNP and the SNM questioned why, for eyents with no medical significance, reporting is required within a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> time period. The same participant also encouraged a clearer delineation for inspection and enforcement of what would trigger an enforcement action in the area of reporting of an unintended exposure. The proposed rule does not, in his opinion, fully clarify the enforcement status of unintended exposures.
- 11. Agenda Items for the Next Meeting l Participants suggested possible topics fer the next meeting, including the following:
-- Identification of specific rules that could be changed that would result in cost savings to licensees;
- Requirements for safety precautions and other proposed requirements for remote afterloaders, brachytherapy, and similar therapeutic uses in f f 35.400 and 35.600.
Discussion on the use of the accreditation programs.
. 1 BY HA'ND October 30,1998 ;
The Honorable Shirley Jackson Chairman U.S. Nuclear Regulatory Commission -
Washington,DC 20555
- Re:
Urgent Request for Extension of Comment Period; 63 Fed. Reg. 43516 (Aug.13,1998); RIN 3150-AF74
Dear Chairman Jackson:
The undersigned organizations are writing to request that the Commission extend the comment period for the ongoing revision of 10 C.F.R. Part 35 to allow for the development of the risk analysis and the rule accordingly. As you may have been informed by staff, it was the unanimous view of participants in the Medical Use Rulemaking Workshop held on October 21-22,1998 that there was simply insufficient time to offer meaningful comments on the proposal by the expiration of the comment period on November 12,1998. Concern was also raised that the current activity surrounding risk analysis (the uncompleted report from the Nuclear Byproduct Material Risk Review Group) is not adequate. We recognize and appreciate that thi program has involved a substantial effort by the Commission and the staff, as evidenced by the presence of Commissioner McGaffigan and Deputy Executive Director Hugh L. Thompson, Jr at substantial portions of the workshop.
Because the regulations the Commission adopts are to be based on risk-informed, performance-based criteria, per your March 20,1997 and June 30,1997 SRMs, we believe that the entire rulemaking extension must take into account the need to conduct an appropriate risk analysis.
The target implementation date of any final rule should also be adjusted by a similar period of time. Because we recognize that the Commission will want to consider this issue carefully, we believe that an immediate extension should be granted.
Last week's workshop made it abundantly clear that the medical community does not believe the proposed rule adequately reflects the stakeholders concept of risk informed rulemaking nor the Commission's din ctive to develop risk-informed requirements. In fact, there was a strong belief that many elements of the proposed rule bear no meaningful relationship to the risk of the materials involved. We are prepared to present to the Commission a proposal that describes in
' detail the type of the risk analysis we believe must be performed along with an estimate of the time involved. Representatives of the medical community will be contacting your office to set up meetmgs to discuss this further.
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4 The Honorable Shirley Jackson
. October 30,1998 Page 2 We recognize that the Commission's decision to rewrite Part 35 was, in part, responsive to medical community's discontent with the existing regulations. Despite that discontent, there appears to be a consensus that operating under the existing rules on a temporary basis, in order to develop an appropriate replacement, is preferable to an incomplete and unsupported p regulation.
The undersigned organizations hope that you will promptly grant our request for an extension of the comment period. This will allow consideration of our proposal that describes in detail the type of the risk analysis we believe must be performed. if you have any questions or requir further information, please contact Mr. David Nichols, Director of Government Relations for ACNP/SNM at (703) 708-9773.
Sincerely, American College of Nuclear Physicians Society of Nuclear Medicine American College of Radiology Council on Radionuclides and Radiopharmaceuticals Nuclear Energy Institute National Electrical Manufacturers Association American College of Nuclear Medicine American Association of Physicists in Medicine cc: The Honorable Edward McGaffigan, Jr., Commissioner The Honorable Nils J. Diaz, Commissioner The Honorable Jeffrey Merrifield, Commissioner The Honorable Greta Joy Dicus, Commissioner Hugh L. Thompson, Jr., Deputy Executive Director Carl J. Paperiello, Ph.D., Director - NMSS
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