Consideration of Petition Rulemaking Process: E. Russell Ritenour, Ph.D

Federal Register: May 14, 2008 (Volume 73, Number 94)

Proposed Rules

Page 27773-27775

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr14my08-21

NUCLEAR REGULATORY COMMISSION 10 CFR Part 35

PRM-35-20; NRC-2006-0020

E. Russell Ritenour, PhD; Consideration of Petition Rulemaking

Process

AGENCY: Nuclear Regulatory Commission.

ACTION: Resolution of petition for rulemaking.

SUMMARY: The Nuclear Regulatory Commission (NRC) will consider the issues raised in the petition for rulemaking submitted by E. Russell

Ritenour, PhD, on behalf of the American Association of Physicists in

Medicine (AAPM), in the rulemaking process. The petitioner requested that the NRC amend its regulations that address training requirements for experienced Radiation Safety Officers (RSOs) and Authorized Medical

Physicists (AMPs). In its review and resolution of the petition, the

NRC concluded that revisions made to the regulations in 2005 may have inadvertently affected a group of board certified professionals.

DATES: The docket for the petition for rulemaking PRM-35-20 is closed on May 14, 2008.

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ADDRESSES: Further NRC action on the issues raised by this petition will be accessible at the federal rulemaking portal, http:// www.regulations.gov, by searching on rulemaking docket ID: [NRC-2008- 0175]. The NRC also tracks all rulemaking actions in the ``NRC

Regulatory Agenda: Semiannual Report (NUREG-0936).''

You can access publicly available documents related to this petition for rulemaking using the following methods:

Federal e-Rulemaking Portal: Go to http://www.regulations.gov and search for documents filed under the following rulemaking docket ID:

NRC-2006-0020

.

NRC's Public Document Room: The public may examine and have copied for a fee publicly available documents at the NRC' Public Document Room

(PDR), Public File Area, Room O1F21, One White Flint North, 11555

Rockville Pike, Rockville, Maryland.

NRC's Agencywide Document Access and Management System (ADAMS):

Publicly available documents created or received at the NRC are available electronically at the NRC's Electronic Reading Room at http:/

/www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr.resource@nrc.gov.

FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and

State Materials and Environmental Management Programs, U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001, telephone 301-415- 0253, e-mail: Edward.Lohr@nrc.gov.

SUPPLEMENTARY INFORMATION:

The Petition

On November 1, 2006 (71 FR 64168), the NRC published a notice of receipt of a petition for rulemaking filed by E. Russell Ritenour, PhD on behalf of the AAPM. The petitioner requested that the NRC amend its regulations in 10 CFR 35.57 to recognize (1) medical physicists certified by the American Board of Radiology (ABR) or the American

Board of Medical Physics (ABMP) on or before October 25, 2005, the date when former 10 CFR Part 35, Subpart J, expired, as grandfathered for the modalities that they practiced as of October 24, 2005, independent of whether or not they have been named on an NRC or Agreement State license as of October 24, 2005; and (2) all diplomates that were certified by named boards in former 10 CFR Part 35, Subpart J, for RSOs who have relevant timely work experience even if they have not been formally named as an RSO or as either Assistant or Associate RSO. These diplomates would be grandfathered as RSOs by virtue of certification providing the appropriate preceptor statement is submitted.

Specific Issues Raised by the Petitioner

The issues asserted by the petitioner can be summarized as follows: 1. Medical physicists have demonstrated their competence to practice through certification by the ABR or the ABMP. 2. There is no evidence to support a rulemaking assertion that

Training and Experience (T&E) requirements for listing as an AMP or RSO acceptable before October 25, 2005, are no longer acceptable as of

October 25, 2005. 3. As a result of the present rule, individuals certified prior to the effective date will have to use the alternate pathway for recognition. AAPM believes that requiring individuals to pursue the alternate pathway for recognition on an NRC or Agreement State license places an undue burden on the medical community without an increase in public or worker health safety and potentially results in an insufficient number of AMPs and RSOs. 4. The number of AMPs and RSOs available to provide preceptor statements are limited and may result in a shortage of AMPs and RSOs. 5. The regulation, as currently written, marginalizes specialty boards.

Public Comments on the Petition

The notice of receipt of the petition for rulemaking invited interested persons to submit comments. The comment period closed on

January 16, 2007. The NRC received 168 comments from professional organizations and individuals. The majority of the commenters supported approving the petition. The main reasons cited can be summarized as follows: 1. Board certifications establish credentials to qualify individuals to serve as RSOs and AMPs, regardless of when the certification was issued. 2. There is no evidence that individuals certified before October, 25, 2005, are less qualified, competent or capable to perform as RSOs or AMPs. Therefore, a board certified individual should not have to use the alternate pathway to qualify as RSO or AMP. 3. The current regulations pose a burden without a corresponding increase in health and safety.

Petition Resolution

In resolving the petition, the NRC determined that the current NRC regulations may inadvertently have an effect on a group of board certified professionals insofar as they may now have to use the alternate pathway option to demonstrate that they meet the T&E requirements in Part 35 rather than the certification pathway for recognition on an NRC license as a RSO or AMP. As a result of revisions of 10 CFR Part 35 T&E requirements in 2005, the requirements that medical specialty boards had to meet in order for their certification processes to be recognized by the NRC were changed. These new requirements applied to the certification processes of new boards and those listed in former 10 CFR Part 35, Subpart J, and affected the status of certifications that had been issued by boards prior to the effective date of the new regulations. Specifically, the previously issued certifications now have to align with the new requirements in order for diplomates holding these certifications to apply for authorized status via board certification pathways.

A provision in the revised regulations ``grandfathered'' certain individuals. Under 10 CFR 35.57(a), only those individuals identified as an RSO, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license or permit before October 24, 2002, or an individual identified as a RSO, AMP, or an authorized nuclear pharmacist between October 24, 2002, and April 29, 2005, were

``grandfathered;'' i.e., need not comply with the training requirements of 10 CFR 35.50, 35.51 or 35.55. The rationale for grandfathering these individuals was that their credentials had been reviewed and accepted during the licensing process and that they had been functioning in their positions and had established an acceptable record of performance. NRC's Advisory Committee on the Medical Use of Isotopes and other stakeholders agreed to this approach.

The petitioner identified a group of board certified professionals that may have been inadvertently affected by the 2005 revisions to the

T&E requirements in 10 CFR Part 35. Specifically, certain individuals certified by boards that had been listed in NRC's former Subpart J, who had not been named on an NRC or Agreement State license or permit prior to October 25, 2005, and therefore were not grandfathered under 10 CFR 35.57, cannot use their board issued

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certifications to qualify them as AMPs or RSOs. Many board certified individuals were working as medical physicists and in radiation safety positions when the T&E requirements were revised but were not named as the authorized individuals on the NRC or Agreement State licenses and, therefore, were not grandfathered under 10 CFR 35.57. These individuals, under the current regulations, may now have to use the alternate pathway option to demonstrate that they meet the T&E requirements in Part 35.

Under the current 10 CFR Part 35 requirements, two individuals, one listed on an NRC or Agreement State license or permit prior to October 25, 2005, and one who was not, with identical certifications, are treated differently. The individual listed on the license is not required to comply with the T&E requirements in Part 35 and the individual not listed must meet the T&E requirements.

In conclusion, the NRC has determined that the petitioner raised a valid concern regarding the impact of the revisions to the T&E requirements in 10 CFR Part 35. Although in the rulemaking process the

NRC staff would need more data than was presented in the petition, sufficient information was presented for the NRC to conduct a review and to determine that the petitioner's concern may warrant relief for certain individuals. Therefore, in resolving the petition, the NRC concluded that the issues raised in the petition will be considered in the rulemaking process in the following way. The NRC will attempt to develop a technical basis to support a rulemaking that would address the issues raised in the petition. If a technical basis which supports rulemaking can be developed, the issues will be addressed in a future rulemaking. If a technical basis to support a rulemaking cannot be developed, the issues will not be further considered by the NRC.

Dated at Rockville, Maryland, this 30th day of April, 2008.

For the Nuclear Regulatory Commission.

Luis A. Reyes,

Executive Director for Operations.

FR Doc. E8-10736 Filed 5-13-08; 8:45 am

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