[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]
 BILLING CODE 7590-01-P