[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40088-40090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17018]
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NUCLEAR REGULATORY COMMISSION
[NRC-2014-0210]
Regulatory Guide 8.11, Revision 1, Applications of Bioassay for
Uranium
AGENCY: Nuclear Regulatory Commission.
ACTION: Regulatory guide; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing
Revision 1 to Regulatory Guide (RG) 8.11, ``Applications of Bioassay
for Uranium.'' This guide provides methods that the NRC staff considers
acceptable for the development and
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implementation of a bioassay program for monitoring the intake of
mixtures of uranium isotopes by occupationally exposed workers. This
guide applies to licenses issued under ``Domestic Licensing of Special
Nuclear Material.''
ADDRESSES: Please refer to Docket ID NRC-2014-0210 when contacting the
NRC about the availability of information regarding this document. You
may access information related to this document, which the NRC
possesses and is publicly available, using any of the following
methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2014-0210. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected].
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Document collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to [email protected]. The
ADAMS accession number for each document referenced in this notice (if
that document is available in ADAMS) is provided the first time that a
document is referenced. Revision 1 of RG 8.11 is available in ADAMS
under Accession No. ML15054A618. The regulatory analysis may be found
in ADAMS under Accession No. ML14133A612.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
Regulatory guides are not copyrighted, and NRC approval is not
required to reproduce them.
FOR FURTHER INFORMATION CONTACT: Harriet Karagiannis, telephone: 301-
251-7477; email: [email protected] or Casper Sun, telephone:
301-251-7912; email: [email protected]. Both are staff of the Office
of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Introduction
The NRC is issuing a revision to an existing guide in the NRC's
``Regulatory Guide'' series. This series was developed to describe and
make available to the public information regarding methods that are
acceptable to the NRC staff for implementing specific parts of the
agency's regulations, techniques that the staff uses in evaluating
specific issues or postulated events, and data that the staff needs in
its review of applications for permits and licenses, or for amendments
to such permits and licenses. The draft Revision 1 of RG 8.11 was
issued with a temporary identification as Draft Regulatory Guide, DG-
8054 and published in the Federal Register to obtain public comments
(79 FR 60190; October 6, 2014).
The NRC issued the initial version of RG 8.11 in June 1974 to
provide guidance to NRC licensees on methods the staff found acceptable
to demonstrate compliance with the then current version of NRC's
radiation protection regulations in 10 CFR part 20. In 1991 the NRC
promulgated amendments to its 10 CFR part 20 regulations (56 FR 23360;
May 21, 1991). The 1991 rulemaking included substantive amendments to
the 10 CFR part 20 regulations as well as a renumbering of those
regulations. As such, this revision (Revision 1) to the guide updates
the guide's cross-references to the current 10 CFR part 20 regulations.
In addition, the guide endorses for use certain sections of a
voluntary consensus standard, namely, the American National Standards
Institute/Health Physics Society N13.22-2013 standard, ``Bioassay
Programs for Uranium,'' as a means for licensees to demonstrate
compliance with the NRC regulations, 10 CFR 20.1201, ``Occupational
Dose Limits for Adults,'' and 10 CFR 20.1204, ``Determination of
Internal Exposure.'' Specifically, 10 CFR 20.1201(e) requires NRC
licensees to limit the soluble uranium intake to an occupational worker
to 10 milligrams in a week, in addition to annual occupational dose
limits, and 10 CFR 20.1204(a) requires NRC licensees to take suitable
and timely measurements of the concentrations of radioactive materials
in air in work areas and the quantities of radionuclides in the bodies
of occupational workers. Finally, this guide identifies the bioassay
interpretation methods in the NRC document NUREG/CR-4884,
``Interpretation of Bioassay Measurement,'' as an acceptable method to
comply with NRC requirements.
II. Additional Information
DG-8054 was published in the Federal Register (79 FR 60190; October
6, 2014) for a 60-day public comment period. The public comment period
closed on December 5, 2014. The NRC received one comment submission.
This comment submission and the staff responses to the comments set
forth in that comment submission are available under ADAMS Accession
Number ML15014A269.
III. Congressional Review Act
This regulatory guide is a rule as defined in the Congressional
Review Act (5 U.S.C. 801-808). However, the Office of Management and
Budget has not found it to be a major rule as defined in the
Congressional Review Act.
IV. Backfitting
Licensees may voluntarily use the guidance in this regulatory guide
(Revision 1 of RG 8.11) to demonstrate compliance with the underlying
NRC regulations. Methods or solutions that differ from those described
in this regulatory guide may be deemed acceptable if they provide
sufficient basis and information for the NRC staff to verify that the
proposed alternative demonstrates compliance with the appropriate NRC
regulations. Current licensees (i.e., persons holding a NRC issued
license as of the date of issuance of this regulatory guide) may
continue to use guidance the NRC found acceptable for complying with
the identified regulations as long as their current licensing basis
remains unchanged. The acceptable guidance may be from the previous
version of this regulatory guide. Licensees may use the information in
this regulatory guide for actions which do not require NRC review and
approval. Licensees may also use the information in this regulatory
guide to resolve regulatory or inspection issues.
The NRC staff does not intend or approve any imposition or
backfitting of the guidance in this regulatory guide (see 10 CFR 70.76,
``Backfitting''). The NRC staff does not expect any current licensee to
use or commit to using the guidance in this regulatory guide, unless
such licensee makes a change to its licensing basis. The NRC staff does
not expect or plan to initiate NRC regulatory action that would require
the use of this regulatory guide. Examples of such regulatory actions
include the issuance of an order or generic communication, or the
promulgation of a rule, requiring the use of this regulatory guide
without further backfit consideration.
During regulatory discussions on licensee-specific operational
issues, the NRC staff may discuss with licensees various actions
consistent with staff positions in this regulatory guide, as one
acceptable means of meeting the
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underlying NRC regulatory requirements. Such discussions would not
ordinarily be considered backfitting, even if prior versions of this
regulatory guide are part of the licensee's licensing basis. However,
unless this regulatory guide is part of the licensee's licensing basis,
the staff may not represent to the licensee that the licensee's failure
to comply with the positions in this regulatory guide constitutes a
violation.
If a current licensee voluntarily seeks a license amendment or
change and (1) the NRC staff's consideration of the request involves a
regulatory issue directly relevant to this regulatory guide and (2) the
specific subject matter of this regulatory guide is an essential
consideration in the staff's determination of the acceptability of the
licensee's request, then the staff may request that the licensee either
follow the guidance in this regulatory guide or provide an equivalent
alternative process that demonstrates compliance with the underlying
NRC regulatory requirements. Such a request by the NRC staff is not
considered backfitting as defined in 10 CFR 70.76(a)(1).
If a licensee believes that the NRC is either using this regulatory
guide or requesting or requiring the licensee to implement the methods
or processes in this regulatory guide in a manner inconsistent with the
discussion in the Implementation section of this regulatory guide, then
the licensee may file a backfit appeal with the NRC in accordance with
the guidance in NRC Management Directive 8.4, ``Management of Facility-
Specific Backfitting and Information Collection'' and NUREG-1409,
``Backfitting Guidelines.''
Dated at Rockville, Maryland, this 8th day of July, 2015.
For the Nuclear Regulatory Commission.
Carol Moyer,
Acting Branch Chief, Regulatory Guidance and Generic Issues Branch,
Division of Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2015-17018 Filed 7-10-15; 8:45 am]
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