ML20195K337
| ML20195K337 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Casarella W AMERICAN BOARD OF RADIOLOGY |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9811250231 | |
| Download: ML20195K337 (1) | |
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'98 N0',' 25 P12 :05 SECRETARY OH l RJ!
ADJU. , ,p William J. Casarella, M.D.
President, American Board of Radiology JOCKET N(WBER I 5255 E. Williams Circle, Suite 3200 oROPOSED RULE $ 40,3NS# l Tucson, AZ 85711-7409 l
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Dear Dr. Casarella:
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1 am responding to your letter dated November 5,1998, requesting that the comment period for l the proposed rule, which would amend the regulations in 10 CFR Part 35," Medical Use of l Byproduct Material," be extended significantly with specific directions to the American Board of j Radiology to develop the consortia-based testing and training programs proposed in the subject letter.
On November 13,1998, via a Staff Requirements Memorandum (enclosed), the Commission l approved a 30-day extension of the public comment period and the final rule date. On i 1
November 23,1998, the Commission announced in the Federal Reaister (63 FR 64829) that the comment period has been reopened until Wednesday, December 16,1998, in addition, the staff will provide a discussion on the need for future risk assessment in this area when the final ;
rule is forwarded to the Commission for approval, in addition, your letter will be docketed as a comment on the proposed 10 CFR Part 35.
Sincerely, John C. Hoyle
Enclosure:
11/13/98 Staff Requirements Memorandum I
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November 13, 1998
%, . . . . . ,o OFFICE OF THE SECRETARY l MEMORANDUM TO: William D. Travers l Ex ctor for O rations 1 tiplDi5 l FROM: Job '. H yly,' ecretary
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SUBJECT:
AFF REQUIREMENTS - SECY-98-263 - PROPOSED RULE: i REVISION OF 10 CFR PART 35, MEDICAL USE OF l BYPRODUCT MATERIAL l
The Commission has approved Option 2B to allow for a 30 day extension of the public comment l period and the final rule date. While the extension of the final rule date is to ensure meaningful l discussion with the ACMUI can be accomplished, the staff should seek to complete as much work as possible in parallel in order to attempt to meet the original due date. In addition, when the proposed final rule is submitted to the Commission, the staff should include a discussion of ,
the risk assessment as an option and provide the pros and cons for this option. ;
1 The Commissioners' offices have designated the following points of contact for work related to the Part 35 revision:
Chairman Jackson's office: James Smith Commissioner Dicus's office: JoelLubenau Commissioner Diaz's office: Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter Commissioner Merrifield's office: Lynne Stauss The staff should continue to follow established procedures for developing and promulgating rulemakings.
I Enclosure MY iMM h/2
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- Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan l Commissioner Merrifield OGC ClO CPO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
- TDje Emerican 3Boarb of Rabiology
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. M. Paul Capp, M.D., Executive Director omceft Assistaat Execuuve Directors G am 8 Casamh M D. Pesadens c,.,,, A L ,ng u o , p., ,un w,,*r*
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,, To the Commissioners:
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,,,,,,Y, , The American Board of Radiology (ABR) writes to express its concerns with the
- 5*~ ca NRC's proposed mle making for Part 35 CFR and to make recommendations for improvement
'E* ""w"'."f. in the aspects of the proposal related to education and testing.
%%* The ABR believes that knowledge of the principles of safety and physics related to the w a u..ua medical utilization of unsealed and sealed radionuclide sources is extremely important. For M.,'", , over 'O years the ABR has successfully administered a written examination that contains
"~ar=+ = material on these subjects as part of its certification process for qualified radiologists and T!%tM," "
co radiation oncologists. The safety record of these diplomates in using radionuclide sources in gjaa wo ,
practice is superb. The ABR believes that such training and testing should continue to be c.uo performed only by medical organizations that have documented qualifications to do so,i.e.,
those approved by the American Board of Medical Specialties (ABMS) and with Accreditation
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Council on Graduate Medical Education (ACGME)- approved residency programs. The ABR
"'l;",,",M " " opposes medical training, testing or examination control by any agency inexperienced in these w s5**wo matters, including government agencies such as the NRC.
y M33,Y. With respect to testing of qualified candidates, the ABR proposes that each ABMS
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board with training related to the use of scaled or unscialed radionuclide sources (e.g., ABR, wa -==~. the American Board of Nuclear Medicine - ABNM, the American Board of Internal Medicine -
ABIM, American Board of Pathology) continue to create its own examination and continue to administer the examination to its own candidates without NRC oversight. Regarding the wwo.n one.i.s, quality and components of the examination in radionuclide safety, the ACMUI should be 5"i*% "" available in an " advice only" capacity should the boards seek such advice about their 3 wn examination. Such examinations that currently are accepted for licensure should continue to be o,,, ,,,,,,. a accepted without further requirements.
'= c** To provide a source of testing for physicians not under the purview of one of these TI.N."v a boards, the relevant exam questions from each of the boards could be pooled and a
'7, ,",0; ,*,f," representative sample selected by a consortium of the involved boards or by ACMUI. This H Redes? Wiehers.M D representative examination then could be delivered to a reputable third party testing agency
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such as Kaplan, Princeton Testing Service (both organizations administer S ATs and other written examinations nationwide) ACT or NBME for administration to all other physicians who meet appropriate qualifications (see below). Thus, a representative examination would be
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ch*'a a ac a available in any region of the nation and presumably on short notice. The details of the third party test administrator's relation to the boards could be developed through an RFP issued by S." " ".'"" "f a consortium of the boards. The ABR is strongly opposed to such testing being done by (less 5
i 7,",53*gn qualified) private testing agencies.11 such agencies are allowed to test, the ABR believes that there will be an inevitable decline of quality in safety and the dhor willh open for numerous l
unqualified practitioners to gain licenses to use radionuclides. d 'l 5256 E. WILLIAMS CIRCLE. SurrE 3200
- TUCSON. ARIZONA 8571174o9 + PHONE (52(3J90-2900 e FAX (520) 790 3200 G 8 o - - a_ a ,n.4, u .e - --. m . e 70 Ill N1 ) F [* h.
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- 1 Regarding the qualifications necessary for individuals other than diplomates of the ABR, ABNM, ABIM or AB Path to sit for the examination, the ABR believes that safe utilization of scaled and unsealed radionuclide sources can be learned only when safety training is integrated with broad-based clinical understanding of the effective utilization of the procedures. Only in this way can physicians utilizing radionuclide sources possibly comply with ALARA principles in their practices. If broad-based clinically relevant training is not required, over-use and mis-use of radionuclides will inevitably occur. The ABR currently requires six months of training in Nuclear Radiology to qualify radiologists in the diagnostic uses of unsealed sources. This is in compliacce with the current NRC regulations and those of the Residency Review Commutee for Radiolohy of the ACGME. A recent vote of Council of the American College of Ra'iiology recommended a 4-month requirement for such clinical training. If the NRC and other relevant constiltencies agree, the ABR would support this somewhat shorEned iequirement, into which could be integrated the 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of specific safety training that the NRC proposes to requir: by law. He ABR would still, however, require a full 12 months of training for those rajiologists wishing to require more sophisticated levels of understanding of radionuclide uses in Ciagnostic imaging, i.e., those who wish to qualify for a Certificate of Special Qualincation in Nuclear Radiology.
To avoid restraints on the availability of radionuclide training, this four-month experience would have to be available to physicians who are not qualified to oc diplomates of the boards. The ABR recommends that you consider a model similar to the model proposed for the testing phase. A consortium of relevant boards could design a clinical curriculum to integrate safety, handling and other requirements with clinical appropriateness training. The curriculum might contain an identical core of experience (e.g.,6-8 weeks) followed by training directed speciGcally at the area or areas ofintended utilization of radionuclide sources. The ABR believes that this training should be administered only within programs or program consortia that are ABMS-approved. These programs exist in every state of the nation, so access should not be a problem.
The ABR believes that the . safety record for utilization of radionuclides in medicine has been excellent. His outstanding record has been obtained by limiting licenses to those individuals who have been trained and tested within relatively narrowly deGned boundaries.
The ABR believes that this outstanding safety record can be maintained only if training and testing continues to be done by reputable, accountable medical organizations that teach safety within the context of clinical applications. We have proposed a way that such programs could be developed and could be made available to all physicians who are willing to make the l
l investment in time and energy to acquire the necessary skills. These are not the approaches that have been proposed by the NRC in its new Part 35 proposal. To proceed with the currently proposed rule making would be a major step backward in education and, ultimately, l in safety for patients, healthcare workers and the public. The ABR requests that the comment period for the Part 35 rule-making proposal be extended signiGeantly with speciGc directions to the ABR to develop the consortia-based testing and training programs proposed in this letter.
We look forward to your comments.
Sincerely, William J. Casarella, MD President, American Board of Radiology