News from the Federal Regulatory Front
ACR Files Comments on Proposed Revision to 10 CFR Part 35, Medical Use of Byproduct Material–Recognition of Specialty Boards (68 FR 68549)
The ACR, in collaboration with the American Society for Therapeutic Radiology and Oncology, the American Association of Physicists in Medicine, the American College of Medical Physicists and the American Board of Science in Nuclear Medicine, submitted extensive comments on the proposed rule related to recognition of specialty boards, the final section in the revision to 10 CFR Part 35, Medical Use of Byproduct Materials. The proposed rule was formulated to separate the requirement for a preceptor statement from the process of granting recognized status to certifying boards.
The need for the proposed rule arose because, in accordance with 10 CFR Part 35, certifying boards such as the American Board of Radiology would have to request recognition by the Nuclear Regulatory Commission or an Agreement State so individual physicians, medical physicists and radiation safety officers can be listed on a license by virtue of having obtained board certification. The NRC then paired this new requirement with a requirement for a preceptor statement signed by someone currently on a license to certify an individual's qualification to be an authorized user, an authorized medical physicist or a radiation safety officer. Because certifying boards do not require such a preceptor statement in their process for determining an individual's board eligibility, the proposed rule was necessary to separate the preceptor requirements from the recognition of board certification.
Once the proposed rule is final, an individual will need to submit a copy of his or her certification and the appropriate preceptor statements in order to be listed as an authorized user, an authorized medical physicist or a radiation safety officer.
Questions and Answers about 10 CFR Part 35
The NRC asked the following questions related to proposed changes to 10 CFR Part 35. The responses of the ACR and its collaborators follow:
Q: Do the proposed revisions to requirements for training and experience provide reasonable assurance that radiation safety officers, authorized medical physicists, authorized nuclear physicists and authorized users have adequate training in radiation safety?
A: Yes. The proposed revisions to the requirements for training and experience appear to be comprehensive and adequate. It is not, however, the regulations per se that provide reasonable assurance that the authorized users, authorized medical physicists and radiation safety officers have adequate training in radiation safety; instead, it is the rigorous educational programs these individuals complete prior to working as AUs, AMPs or RSOs. We request that the commission consider the totality of all work experience for individuals who have completed an accredited residency program and/or achieved board certification as reasonable assurance of adequate training in radiation protection and safety. Most training programs exceed the requirements delineated in the alternative pathway.
Q: Should Agreement States establish the requirements to conform to this proposed rule by Oct. 24, 2005, or should they follow the normal process and be given a full three years to develop a compatible rule?
A: Although we would prefer that the rule be finalized and effective as soon as possible, we recognize potential difficulties in developing comparable regulations for the Agreement States. The Agreement States should be urged to adopt comparable regulations as soon as practical, given the states' legislative and regulatory processes. We would not object, however, to granting a full three years for adoption, providing the compatibility level for these regulations remains at a "Compatibility B" (meaning the states must adopt language essentially verbatim to NRC language).
Q: Should the word "attestation" be used in place of the word "certification" in the preceptor statements?
A: Yes. We believe it is absolutely critical to change the word "certification" to "attestation" in all the preceptor paragraphs. More specifically, we recommend that the following be inserted in place of the first sentence of all preceptor paragraphs in the Dec. 9, 2003, draft:
Has obtained written attestation that the individual has satisfactorily completed the required training in paragraph (a)(1) or (b)(1) of this section and has achieved a level of knowledge and demonstrated the ability to safely handle radioisotopes to ensure adequate protection of public health and safety. The written attestation must be signed by a preceptor . . .
Questions can be directed to Gloria Romanelli, director of federal programs for the ACR, at gloriar@acr.org or (703) 716-7550.
