[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Proposed Rules]
[Pages 7819-7820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02158]

Proposed Rules
                                                Federal Register

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.


Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / 
Proposed Rules

[[Page 7819]]


10 CFR Parts 30 and 32

[Docket No. NRC-2015-0017]
RIN 3150-AJ54

Items Containing Byproduct Material Incidental to Production

AGENCY: Nuclear Regulatory Commission.

ACTION: Regulatory basis; request for comment.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is requesting 
comment on a regulatory basis to support developing a rulemaking that 
would amend its regulations by adding a new class exemption from 
licensing and associated distribution requirements. This new class 
exemption would create a path for licensing current and future products 
that contain byproduct material incidental to their production. The 
rulemaking would resolve a petition for rulemaking (PRM), PRM-30-65, 
submitted by GE Osmonics, Inc. on April 18, 2011, requesting changes to 
the regulations to allow commercial distribution and redistribution of 
polycarbonate track etched membranes.

DATES: Submit comments by April 5, 2021. 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 before this 

ADDRESSES: You may submit comments by any of the following methods; 
however, the NRC encourages electronic comment submission through the 
Federal Rulemaking Website:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0017. Address 
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407; 
email: [email protected]. For technical questions, contact the 
individual(s) listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Email comments to: [email protected]. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Alexa Sieracki, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-7509; email: 
[email protected].


I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2015-0017 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0017.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, 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]. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     Attention: The Public Document Room (PDR), where you may 
examine and order copies of public documents is currently closed. You 
may submit your request to the PDR via email at [email protected] or 
call 1-800-397-4209 between 8:00 a.m. and 4:00 p.m. (EST), Monday 
through Friday, except Federal holidays.

B. Submitting Comments

    The NRC encourages electronic comment submission through the 
Federal Rulemaking Website (https://www.regulations.gov). Please 
include Docket ID NRC-2015-0017 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at 
https://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. 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 into ADAMS.

II. Discussion

    To facilitate early stakeholder engagement on the rulemaking 
process, the NRC is requesting comment on a regulatory basis to support 
a rulemaking that would amend (1) part 30 of title 10 of the Code of 
Federal Regulations (10 CFR), ``Rules of General Applicability to 
Domestic Licensing of Byproduct Material,'' by adding a new class 
exemption from licensing requirements for items containing byproduct 
material incidental to their production, and (2) 10 CFR part 32, 
``Specific Domestic Licenses to Manufacture or Transfer Certain Items 
Containing Byproduct Material,'' licensing requirements for 
distribution of those items.
    The regulatory basis is developed as a precursor to a proposed rule 
and describes the NRC's preferred approach for resolving PRM-30-65. The 
rulemaking would close the regulatory gap for these irradiated 
products, create appropriate criteria for evaluating public health and 
safety impacts of these products, reduce burden on existing licensees, 
and provide consistency for regulating products within this class.

[[Page 7820]]

    The NRC will consider any comments received on the regulatory basis 
in the development of the proposed and final rule and will provide 
responses to comments on the regulatory basis in the associated Federal 
Register notification publishing the proposed rule for public comment.

III. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31883). The NRC requests comment on this document with respect to the 
clarity and effectiveness of the language used.

IV. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 

                                                ADAMS accession No./web
                  Document                      link/ Federal Register
Regulatory Basis for Items Containing         ML20339A400.
 Byproduct Material Incidental to
 Production, January 13, 2021.
Petition for Rulemaking Submitted by Annette  77 FR 56793.
 User on Behalf of GE Osmonics
 (Consideration in the Rulemaking Process),
 September 14, 2012.
GE Osmonics, Inc., Polymer Track Etch         ML120800277.
 Membrane 10 CFR 32.14--Manufacturer and
 Distribution Product Safety Information,
 March 20, 2012.
GE Osmonics, Inc., Environmental Report--     ML120800264.
 Polymer Track Etch Membrane--10 CFR 30.15,
 March 20, 2012.
NRC Consumer Product Policy Statement,        79 FR 2907.
 January 16, 2014.
Petition for Rulemaking Submitted by Annette  ML120250133.
 User on Behalf of GE Osmonics, April 18,
SECY-87-186A, Distribution of Radioactive     ML092400170.
 Gems Irradiated in Reactors to Unlicensed
 Persons (Follow-up to SECY-87-186), October
 5, 1987.
Petition for Rulemaking Submitted by Annette  76 FR 36386.
 User on Behalf of GE Osmonics (Receipt and
 Request for Comment), June 22, 2011.
Comment (1) of Benjamin Kerensa Opposing      ML11178A021.
 Petition for Rulemaking (PRM-30-65)
 Regarding the NRC Amend Its Regulations
 Regarding the Commercial Distribution of
 Byproduct Material, June 24, 2011.
Agreement State Program Policy Statement;     82 FR 48535.
 Correction, October 18, 2017.
Management Directive 5.3, Agreement State     ML18073A142.
 Participation in NRC Working Groups, June
 22, 2016.
NUREG-1556, Volume 8, Revision 1,             ML18158A165.
 Consolidated Guidance about Materials
 Licenses: Program-Specific Guidance About
 Exempt Distribution Licenses, June 2018.
Strategic Plan: Fiscal Years 2018-2022,       ML18032A561.
 NUREG-1614, Volume 7, February 2018.
International Atomic Energy Agency, OECD      https://www.iaea.org/
 Nuclear Energy Agency, Radiation Safety for   publications/10716/
 Consumer Products, IAEA Safety Standards      radiation-safety-for-
 Series No. SSG-36, January 2016.              consumer-products.
International Atomic Energy Agency, IAEA      https://www.iaea.org/
 Safety Standards Series, Radiation            publications/8930/
 Protection and Safety of Radiation Sources:   radiation-protection-and-
 International Basic Safety Standards--        safety-of-radiation-
 General Safety Requirements Part 3 No. GSR    sources-international-
 Part 3, July 2014.                            basic-safety-standards.

    The NRC may post documents related to this rulemaking activity to 
the Federal rulemaking website at https://www.regulations.gov under 
Docket ID NRC-2015-0017.
    The Federal rulemaking website allows you to receive alerts when 
changes or additions occur in a docket folder. To subscribe: (1) 
Navigate to the docket folder (NRC-2015-0017); (2) click the ``Sign up 
for Email Alerts'' link; and (3) enter your email address and select 
how frequently you would like to receive emails (daily, weekly, or 

    Dated January 15, 2021.

    For the Nuclear Regulatory Commission.
John R. Tappert,
Director, Division of Rulemaking, Environmental, and Financial Support, 
Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2021-02158 Filed 2-1-21; 8:45 am]