[Federal Register Volume 73, Number 94 (Wednesday, May 14, 2008)]
[Proposed Rules]
[Pages 27773-27775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10736]
-----------------------------------------------------------------------
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.
[[Page 27774]]
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
[email protected].
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: [email protected].
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
[[Page 27775]]
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]
BILLING CODE 7590-01-P