[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Pages 54752-54753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21757]




Applications of Bioassay for Radioiodine

AGENCY: Nuclear Regulatory Commission.

ACTION: Regulatory guide; issuance.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing 
Revision 2 to Regulatory Guide (RG) 8.20, ``Applications of Bioassay 
for Iodine-125 and Iodine-131.'' The title of this regulatory guide has 
been changed to ``Applications of Bioassay for Radioiodine.'' It 
describes methods and criteria acceptable to the NRC staff for the 
development and implementation of a bioassay program by licensees 
handling or processing unsealed materials containing Iodine-123 (I-
123), Iodine-124 (I-124), Iodine-125 (I-125), Iodine-129 (I-129), and 
Iodine-131 (I-131), or a combination of these radionuclides.

ADDRESSES: Please refer to Docket ID NRC-2011-0224 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this action by the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0224. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. For technical questions, contact 
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the NRC 
Library 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]. Revision 2 of RG 8.20 is 
available in ADAMS under Accession No. ML14064A060. The regulatory 
analysis may be found in ADAMS under Accession Number ML14064A058.
     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: Casper Sun, telephone: 301-251-7912, 
email: [email protected]; or Harriet Karagiannis, telephone: 301-251-
7477, email: [email protected]. Both are staff of the Office 
of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001.


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 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 
problems or postulated accidents, and data that the staff needs in its 
review of applications for permits and licenses.
    Revision 2 of RG 8.20 was issued with a temporary identification as 
draft regulatory guide (DG), DG-8050, entitled, ``Applications for 
Bioassay for Radioiodine.'' This guide was revised to achieve better 
alignment with: (1) Part 20 of Title 10 of the Code of Federal 
Regulations (10 CFR); and (2) the internal dose assessment methods 
recommended by the International Commission on Radiological Protection 
Publication 30, ``Limits for Intakes of Radionuclides by Workers.'' The 
content of the guide was also simplified by removing the appendixes of 
the previous version and including pertinent information in the main 
sections of the guide. Also, the title was changed because the guide 
now includes three more radioiodines (I-123, I-124, and I-129), in 
addition to the two radioiodines (I-125 and I-131) that were included 
in the previous version.

II. Additional Information

    This DG-8050 was published in the Federal Register on September 26, 
2011, (76 FRN 59448) for a 60-day public comment period. The public 
comment period closed on November 22, 2011. Public comments on DG-8050 
and the NRC staff's responses to the public comments are available in 
ADAMS under Accession No. ML14064A061.

III. Congressional Review Act

    This RG 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 and Issue Finality

    This RG describes methods that the staff of the NRC considers 
acceptable for the development and implementation of bioassay programs 
for adult workers and for licensees handling or processing unsealed 
materials containing I-123, I-124, I-125, I-129, and I-131 or a 
combination of these radionuclides. Some of the applicants and 
licensees to whom this regulatory guide applies are protected by 
backfitting provisions in certain parts of 10 CFR Chapter I and/or the 
issue finality provisions in 10 CFR part 52.
    Issuance of this RG does not constitute backfitting under 10 CFR 
50.109, 10 CFR 70.76, 10 CFR 72.62, or 10 CFR 76.76, and is not 
inconsistent with any issue finality provisions in 10 CFR part 52. As 
discussed in the ``Implementation'' section of this regulatory guide, 
the NRC has no current intention to impose this regulatory guide on any 
licensees, including holders of licenses protected by the backfitting 
and issue finality provisions listed above. Applicants for the licenses 
listed above are not protected by any backfitting and issue finality 
provisions. Backfitting and the issue finality provisions--with certain 
exclusions discussed below--are not intended to apply to every NRC 
action which substantially changes the expectations of current and 
future applicants. The exceptions to the general principle are 
applicable whenever an applicant references a part

[[Page 54753]]

52 license (e.g., an early site permit) and/or NRC's regulatory 
approval (e.g., a design certification rule) with specified issue 
finality provisions. The staff does not, at this time, intend to impose 
the positions represented in this RG in a manner that is inconsistent 
with any part 52 issue finality provisions. If, in the future, the 
staff seeks to impose a position in the regulatory guide section in a 
manner which does not provide issue finality as described in the 
applicable issue finality provision, then the staff must address the 
criteria for avoiding issue finality in that issue finality provision.

    Dated at Rockville, Maryland, this 8th day of September, 2014.

    For the Nuclear Regulatory Commission.
Thomas H. Boyce
Chief, Regulatory Guidance and Generic Issues Branch, Division of 
Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2014-21757 Filed 9-11-14; 8:45 am]