[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Proposed Rules]
[Pages 29016-29017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11551]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 71

[NRC-2013-0082; NRC-2008-0198]
RIN 3150-AI11


Establishing Quality Assurance Programs for Packaging Used in 
Transport of Radioactive Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft regulatory guide; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
amend its regulations for the packaging and transportation of 
radioactive material. The NRC is issuing for public comment draft 
regulatory guide (DG), DG-7009, ``Establishing Quality Assurance 
Programs for Packaging Used in Transport of Radioactive Material.'' 
This draft regulatory guide describes a proposed method that the NRC 
staff considers acceptable for use in complying with the NRC's proposed 
amendments to its regulations on quality assurance programs related to 
transport of radioactive materials.

DATES: Submit comments by July 30, 2013. Comments received after this 
date will be considered if it is practical to do so, but the NRC is 
able to ensure consideration only for comments received on or before 
this date. Although a time limit is given, comments and suggestions in 
connection with items for inclusion in guides currently being developed 
or improvements in all published guides are encouraged at any time.

ADDRESSES: You may submit comments by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0082. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: Carol.Gallagher@nrc.gov. For technical questions, contact 
the individuals listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     Mail comments to: Cindy Bladey, Chief, Rules, 
Announcements, and Directives Branch (RADB), Office of Administration, 
Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
     Fax comments to: RADB at 301-492-3446.
    For additional direction on accessing information and submitting 
comments, see ``Accessing Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Jessica Glenny, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-492-
3285, email: Jessica.Glenny@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Accessing Information and Submitting Comments

A. Accessing Information

    Please refer to Docket ID NRC-2013-0082 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, by the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0082.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access 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 pdr.resource.gov@nrc.gov">pdr.resource.gov@nrc.gov. The draft regulatory 
guide is available in ADAMS under Accession No. ML13079A004. The draft 
regulatory analysis for the proposed rule may be found in ADAMS under 
Accession No. ML13079A005. Because this draft regulatory analysis 
explains the reasons for revising the rule and its implementing 
guidance, a separate regulatory analysis was not prepared for this 
draft regulatory guide.
     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.

B. Submitting Comments

    Please include Docket ID NRC-2013-0082 in the subject line of your 
comment submission, in order to ensure that the NRC is able to make 
your comment submission available to the public in this docket.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in you 
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission.

[[Page 29017]]

Your request should state that the NRC does not routinely edit comment 
submissions to remove such information before making the comment 
submissions available to the public or entering the comment submissions 
into ADAMS.

II. Proposed Rule

    In the Proposed Rules section of this issue of the Federal 
Register, the NRC published a proposed rule, ``Revisions to 
Transportation Safety Requirements and Harmonization with International 
Atomic Energy Agency Transportation Requirements'' (RIN 3150-AI11; NRC-
2008-0198), that would amend its regulations for the packaging and 
transportation of radioactive material in Part 71 of Title 10 of the 
Code of Federal Regulations (10 CFR). These amendments would make the 
NRC's regulations compatible with the 2009 edition of the International 
Atomic Energy Agency's (IAEA) transportation standards, ``Regulations 
for the Safe Transport of Radioactive Material'' (TS-R-1); maintain 
consistency with changes in the U.S. Department of Transportation's 
regulations; and make other changes to the requirements for the 
packaging and transportation of radioactive material.

III. Draft Regulatory Guide

    The NRC is issuing for public comment a draft regulatory guide in 
the NRC's ``Regulatory Guide'' series. This series was developed to 
describe and make available to the public such information as methods 
that are acceptable to the NRC staff for implementing specific parts of 
the NRC'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.
    In conjunction with the proposed rule, the NRC is issuing DG-7009, 
``Establishing Quality Assurance Programs for Packaging Used in 
Transport of Radioactive Material.'' The draft regulatory guide is 
temporarily identified by its task number, DG-7009. The DG-7009 is 
proposed Revision 3 of Regulatory Guide 7.10, with the same title, 
dated March 2005, available in ADAMS under Accession No. ML050540330.
    This draft regulatory guide describes a proposed method that the 
NRC staff considers acceptable for use in complying with the NRC's 
proposed regulations on quality assurance (QA) programs related to 
transport of radioactive materials.
    This draft regulatory guide is being revised to address changes to 
the regulation of QA programs issued under 10 CFR part 71. These 
changes include: (1) establishing requirements to allow some changes to 
be made to a previously approved QA program without obtaining NRC 
approval, and (2) removing the requirements for renewal of QA program 
approvals.
    If adopted in final form, DG-7009 would supersede Regulatory Guide 
7.10, Revision 2, and would represent the NRC staff's guidance for 
future users, including licensees, certificate holders, and applicants.

IV. Backfitting and Issue Finality

    This draft regulatory guide contains proposed NRC guidance on one 
acceptable means of addressing NRC requirements in 10 CFR part 71 on QA 
programs related to transport of radioactive materials. The NRC 
proposes to determine that the draft regulatory guide may be adopted in 
final form without preparation of a backfit analysis or further 
documentation of backfitting and issue finality. There are two bases 
for the NRC's proposed determination, which are addressed separately in 
the following paragraphs.

Lack of Backfitting or Issue Finality Provisions Applicable to Entities 
With Respect to Requirements in 10 CFR Part 71

    Part 71 of 10 CFR does not contain any backfitting or issue 
finality provisions protecting persons and entities subject to its 
provisions. The NRC recognizes that persons and entities required to 
comply with the 10 CFR Part 71 QA requirements, such as nuclear power 
plant licensees, may also be protected by backfitting and issue 
finality protection under other parts of 10 CFR Chapter I. Nonetheless, 
it is the NRC's position that those backfitting and issue finality 
protections are limited to activities directly regulated under those 
parts, and do not apply to activities regulated under other parts 
without backfitting or issue finality protections. The exception to 
this general principle is where the activity regulated under other 
parts without backfitting or issue finality protections is an 
inextricable part of the regulated activity subject to backfitting or 
issue finality.
    However, the exception to this principle is not applicable to the 
issuance of this regulatory guide, which addresses QA for 
transportation of radioactive materials. Nuclear power plant licensees, 
for example, are protected by backfitting requirements in 10 CFR 
50.109, and (depending upon the circumstance) issue finality 
requirements in 10 CFR part 52. Nonetheless, quality assurance 
governing transportation of certain radioactive materials is not an 
inextricable part of the licensed activity in 10 CFR parts 50 and 52, 
viz. the design, construction and operation of a nuclear power plant. 
Analogous arguments also apply with respect to entities protected by 
backfitting requirements in 10 CFR parts 70, 72, and 76.

First Issuance of Guidance on a New or Amended Regulation

    This draft regulatory guide addresses proposed changes to the 
regulation of QA programs issued under 10 CFR Part 71, which are being 
published in a companion notice in this issue of the Federal Register. 
These changes include: (1) establishing requirements to allow some 
changes to be made to a previously approved QA program without 
obtaining NRC approval, and (2) removing the requirements for renewal 
of QA program approvals. The first issuance of guidance on a newly-
changed or newly-added rule provision does not constitute backfitting 
or raise issue finality concerns, inasmuch as the guidance must be 
consistent with the regulatory requirements in the newly-changed or 
newly-added rule provisions and the backfitting and issue finality 
considerations applicable to the newly-changed or newly-added rule 
provisions must logically apply to this guidance. Therefore, issuance 
of guidance addressing the newly-changed and newly-added provisions of 
the amended rule does not constitute issuance of ``changed'' or ``new'' 
guidance within the meaning of the definition of ``backfitting'' in 10 
CFR 50.109(a)(1). Similarly, the issuance of the guidance addressing 
the newly-changed or newly-added provisions of the amended rule, by 
itself, does not constitute an action inconsistent with any of the 
issue finality provisions in 10 CFR part 52.
    Accordingly, no further consideration of backfitting or issue 
finality is needed in order to issue this draft regulatory guide in 
final form.

    Dated at Rockville, Maryland, this 30th day of April, 2013.

    For the Nuclear Regulatory Commission.
Thomas H. Boyce,
Chief, Regulatory Guide Development Branch, Division of Engineering, 
Office of Nuclear Regulatory Research.
[FR Doc. 2013-11551 Filed 5-15-13; 8:45 am]
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