[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Proposed Rules]
[Pages 38012-38020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13599]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30 and 32

[NRC-2015-0017]
RIN 3150-AJ54


Items Containing Byproduct Material Incidental to Production

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule and draft guidance; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
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. This 
rulemaking would resolve a petition for rulemaking submitted by GE 
Osmonics, Inc., that requested changes to the regulations to allow 
distribution of polycarbonate track etched membranes. The NRC plans to 
hold a public meeting to promote full understanding of the proposed 
rule and facilitate public comments.

DATES: Submit comments by September 12, 2022. 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 
date.

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); 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 listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.

[[Page 38013]]

     Email comments to: [email protected]. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
    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: Shirley Xu, telephone: 301-415-7640; 
email: [email protected]; and Caylee Kenny, telephone: 301-415-7150; 
email: [email protected]. Both are staff of the Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Obtaining Information and Submitting Comments
    A. Obtaining Information
    B. Submitting Comments
II. Background
    A. Petition for Rulemaking (PRM-30-65)
    B. Existing Regulatory Framework for Irradiated Products 
Containing Byproduct Material Incidental to Production
    C. Recent Rulemaking Actions
III. Discussion
    A. What action is the NRC taking?
    B. What persons would this action affect?
    C. Why do the requirements need to be revised?
IV. Section-by-Section Analysis
V. Regulatory Flexibility Certification
VI. Regulatory Analysis
VII. Backfitting and Issue Finality
VIII. Cumulative Effects of Regulation
IX. Plain Writing
X. National Environmental Policy Act
XI. Paperwork Reduction Act
XII. Criminal Penalties
XIII. Coordination With Agreement States
XIV. Compatibility of Agreement State Regulations
XV. Availability of Guidance
XVI. Public Meeting
XVII. Availability of Documents

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, at 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.
     NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's Public Document Room (PDR), 
Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland 20852. To make an appointment to visit the PDR, please send an 
email to [email protected] or call 1-800-397-4209 or 301-415-4737, 
between 8:00 a.m. and 4:00 p.m. (ET), 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. Background

A. Petition for Rulemaking (PRM-30-65)

    On April 18, 2011, GE Osmonics, Inc., submitted a petition for 
rulemaking (PRM), PRM-30-65, that requested the NRC amend its 
regulations to allow commercial distribution of polycarbonate track 
etched (PCTE) membranes. The PCTE membranes are used in a variety of 
research, medical, pharmaceutical, academic, scientific, and industrial 
applications. The membranes are irradiated (exposed to radiation in, 
for example, a research and test reactor), to create uniform pore size 
and distribution, which leaves small amounts of mixed fission products 
in the membranes. The incidental radioactivity of these products 
presents a small fraction, less than a few hundredths, of the public 
dose limits in NRC regulations, as based on the product safety analyses 
submitted by the petitioner on March 20, 2012.
    The NRC docketed the petition and, on June 22, 2011, the NRC 
published a notice of docketing and request for public comment (76 FR 
36386). The NRC received one comment and, on September 14, 2012, the 
NRC published a document in the Federal Register (77 FR 56793) stating 
that the petitioner raised a valid regulatory issue about the 
commercial distribution of PCTE membranes and that the NRC would 
consider the issue in the rulemaking process.

B. Existing Regulatory Framework for Irradiated Products Containing 
Byproduct Material Incidental to Production

    Under part 30 of title 10 of the Code of Federal Regulations (10 
CFR), ``Rules of General Applicability to Domestic Licensing of 
Byproduct Material,'' the NRC regulates the manufacturing, production, 
transfer, receipt, acquisition, ownership, possession, and use of 
byproduct material. Typically, the NRC regulates these processes 
through a specific or general license. The regulations in Sec.  30.11, 
``Specific exemptions,'' through Sec.  30.22, ``Certain industrial 
devices,'' provide exemptions from certain licensing requirements. 
Under 10 CFR part 32, ``Specific Domestic Licenses to Manufacture or 
Transfer Certain Items Containing Byproduct Material,'' the NRC 
regulates the manufacture and initial transfer of items containing 
byproduct material for sale or distribution. The regulations in Sec.  
32.11, ``Introduction of byproduct material in exempt concentrations 
into products or materials, and transfer of ownership or possession: 
Requirements for license,'' provide the requirements for obtaining a 
specific license authorizing the introduction of byproduct material 
into a product or material that will eventually be transferred to a 
person exempt from the licensing requirements.

[[Page 38014]]

    Both Sec. Sec.  32.11 and 30.14 provide that, for exempt 
distribution, the concentrations of byproduct material in a product 
cannot exceed the values listed in Schedule A in Sec.  30.70. However, 
these regulations are not applicable to this class of products because 
the current regulations do not apply to items that contain byproduct 
material incidental to production; therefore, these items cannot be 
licensed for exempt transfers. For the specific case of irradiated 
gemstones, in the staff requirements memorandum for SECY-87-186A, the 
Commission approved the interim licensing of irradiated gemstones 
pursuant to Sec.  32.11 with an exemption from requirements that 
prohibit application of products to a human being. Although this 
regulatory approach has been applied to irradiated gemstones, the 
existing regulatory framework is not designed to regulate the broader 
class of items containing byproduct material incidental to production 
for several reasons.
    First, the concentrations in Schedule A pertain to volumetric 
concentrations in an item containing byproduct material. While 
volumetric concentrations are useful and appropriate for assessing some 
products, the NRC is aware of certain products (e.g., polycarbonate 
membranes, which are thin films) for which volumetric concentrations 
would not be meaningful due to the products' shape. Consequently, the 
basis for using volumetric concentrations for products covered by 
Schedule A would not be applicable to several items that are in this 
class of products.
    Second, the maximum concentration limits of Schedule A are based on 
the potential internal dose from inhalation or ingestion. Potential 
doses from the irradiated products under consideration, when used as 
intended, would likely result from external exposures, such as the 
wearing of a gemstone or the handling of a PCTE membrane. Therefore, 
using the Schedule A concentration limits would not be appropriate for 
this class of products.
    Third, the list of radionuclides in Schedule A is not sufficiently 
comprehensive to cover all potential radionuclides present in this 
class of products. While some of the potential radionuclides in these 
products would fall within the catch-all provision of Schedule A (i.e., 
beta- or gamma-emitting byproduct material with a half-life less than 3 
years), Schedule A does not capture other radionuclides that are 
present in this class of products. For example, PCTE membranes are 
exposed to nuclear fission fragments, including strontium-90, which 
remain embedded in the membranes. Schedule A has never specifically 
included strontium-90 in the table, and strontium-90 would not fall 
within the catch-all provision of Schedule A because its half-life is 
more than 27 years. As a result, Schedule A would not cover several 
items in this class of products, such as PCTE membranes, because it 
does not capture, either specifically or in the catch-all provision, 
all radionuclides that may be present in these products.
    These irradiated products are widely used in a variety of 
beneficial applications (e.g., pharmaceutical, water filtration), and a 
regulatory structure provides certainty in a pathway to licensing for 
this class of products. As a result, revising the regulations is 
appropriate to allow the use of these products under the exemption and 
distribution provisions in 10 CFR parts 30 and 32.

C. Recent Rulemaking Actions

    A regulatory basis was published in the Federal Register on 
February 2, 2021 (86 FR 7819). The NRC did not receive any public 
comments on the regulatory basis to inform this proposed rulemaking.

III. Discussion

A. What action is the NRC taking?

    This proposed rule would amend 10 CFR parts 30 and 32 to (1) add a 
new class exemption from licensing requirements to 10 CFR part 30 and 
(2) add associated distribution requirements to 10 CFR part 32. These 
changes would apply dose criteria, rather than concentration, as the 
primary means of protecting health and safety. These proposed changes 
would fully address PRM-30-65, provide a regulatory framework for 
current (i.e., gemstones) and future irradiated products, and allow 
this class of products to be licensed without product-specific 
exemptions, which would otherwise require additional rulemaking in the 
future. This new regulatory structure would require a licensee to meet 
dose-based criteria, which would reduce the regulatory costs for 
current gemstone licensees, who currently provide both concentration 
and dose-based criteria. Additionally, as described below, this 
proposed rule would make conforming changes to include the new 
Sec. Sec.  32.33, ``Requirements for license of items containing 
byproduct material incidental to production and transfer of ownership 
or possession,'' and 32.34, ``Items containing byproduct material 
incidental to production safety criteria,'' under Sec.  32.303, 
``Criminal penalties.''
    In addition to providing dose measurements, the current 
distributors of irradiated gemstones use a variety of measurements and 
statistical analysis methods to demonstrate that the concentration of 
byproduct material at the time of sale to consumers is unlikely to 
exceed the concentration limits in Sec.  30.70 (and derived 
concentrations for those not specifically included). Under the new 
provisions, current gemstone licensees and applicants (initial 
distributor or transferrer) would demonstrate that their products are 
unlikely to result in doses exceeding the dose criteria in the new 
provisions.
    The NRC would amend 10 CFR part 30 to add new Sec.  30.23, ``Items 
containing byproduct material incidental to production,'' specific to 
products containing byproduct material that is not part of the intended 
end use of the product, but is instead present as a result of 
production. This new section would only apply to items produced in a 
way that unavoidably results in the incidental addition of byproduct 
material to the final product. The NRC would add companion paragraphs 
to 10 CFR part 32 that would provide the applicable licensing 
requirements for distribution. The new section, 10 CFR 30.23, would 
only apply to those products or materials that have an exempt 
distribution license under Sec.  32.33.
    In the past, the NRC has established class exemptions for 
categories of products or devices with similar characteristics, rather 
than establishing individual exemptions for each product. These 
exemptions appear in Sec. Sec.  30.19, ``Self-luminous products 
containing tritium, krypton-85, or promethium-147''; 30.20, ``Gas and 
aerosol detectors containing byproduct material''; and 30.22, ``Certain 
industrial devices.'' This planned rulemaking approach is similar to 
that for Sec. Sec.  30.19, 30.20, and 30.22 in that the regulatory 
structure would allow new products containing byproduct material 
incidental to production to be licensed without product-specific 
exemptions; each of which would otherwise require additional 
rulemaking. Public health and safety are ensured by evaluating each 
specific product against safety criteria contained in the regulations 
that apply to all products in the class.
    The new provision would be similar in some respects to the class 
exemptions in the current regulations in that it would require 
applicants requesting authorization to distribute a product or material 
to demonstrate that the product or material meets certain safety 
criteria. The NRC specifies these safety criteria in Sec. Sec.  32.23, 
``Same [Self-luminous

[[Page 38015]]

products containing tritium, krypton-85 or promethium-147]: Safety 
criteria''; 32.27, ``Same [Gas and aerosol detectors containing 
byproduct material]: Safety criteria''; and 32.31, ``Certain industrial 
devices containing byproduct material: Safety criteria.'' These safety 
criteria would form the primary means of providing reasonable assurance 
of adequate protection of public health and safety. Applicants 
requesting authorization to manufacture, possess, or distribute items 
containing byproduct material incidental to production would be 
required to demonstrate compliance with the safety criteria. These 
criteria would cover normal use, handling, storage, marketing, 
distribution, installation, servicing, and disposal, as well as 
potential accidents and misuse.
    During the development of the regulatory basis for this proposed 
rulemaking, the NRC considered the following specific issues for this 
proposed rule:
    (1) The need for establishing standards for the exempt distribution 
of products that contain byproduct material that is incidental to 
production. These standards would include requiring applicants to 
provide information relating to the design, manufacture, prototype 
testing (if applicable), quality control procedures, labeling and 
marking, and conditions of handling, storage, use, and disposal of the 
products to demonstrate that the product would meet the following 
specific safety criteria:
    (a) Dose limits to the general public and those occupationally 
exposed \1\ to the product, including through transportation, 
distribution, use, and disposal; and
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    \1\ Individuals occupationally exposed include PCTE membrane 
manufacturers, truck drivers, warehouse workers, and waste disposal 
workers. For class exemptions, the existing criteria for such groups 
are 5-20 millirem (mrem)/year (50-200 microsieverts ([mu]Sv)/year) 
except for disposal scenarios for which the criterion is 1 mrem/year 
(10 [mu]Sv/year), because the same individuals could be impacted by 
all of the products allowed to be disposed in landfills and 
municipal incinerators.
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    (b) Prototype testing (if applicable) to demonstrate the degree of 
binding or containment that is necessary under the most severe 
conditions likely to be encountered in normal use of the product.
    (2) The need for establishing ongoing requirements for the exempt 
distribution of products approved for distribution under the new 
provision in the proposed rule:
    (a) Labeling requirements for the product and for final product 
packaging,
    (b) Quality control/quality assurance, and
    (c) Recordkeeping and annual transfer reporting.
    These new provisions in the proposed rule can be applied 
generically and would present an appropriate regulatory framework for 
irradiated products of this class. They would allow for new products 
and materials to be developed, evaluated, and licensed under a 
framework that would adequately protect health and safety without the 
need for additional rulemaking. The safety criteria would be robust 
enough to cover any potential future irradiated products. In the long 
term, these comprehensive proposed changes would be the most cost-
effective solution to the NRC, licensees, and applicants because other 
irradiated products are expected to be brought to market in the future.

B. What persons would this action affect?

    This proposed rule, if adopted, would apply to persons who submit 
an application for current and future products that contain byproduct 
material incidental to production. Examples include PCTE membranes, 
irradiated gemstones, and certain silicon materials used in the 
electronics industry.

C. Why do the requirements need to be revised?

    As noted in the ``Background'' section of this document, the 
current 10 CFR parts 30 and 32 regulations do not cover items that 
contain byproduct material incidental to production; therefore, these 
items cannot be licensed for exempt transfers. As a result, revising 
the regulations is appropriate to allow the potential use of these 
products under the exemption and distribution provisions in 10 CFR 
parts 30 and 32.

IV. Section-by-Section Analysis

    The following paragraphs describe the specific changes proposed by 
this rulemaking.

Section 30.23 Items Containing Byproduct Material Incidental to 
Production

    This proposed rule would add new Sec.  30.23 to require applicants 
to demonstrate that the product or material for distribution would meet 
certain safety criteria.

Section 32.33 Requirements For License of Items Containing Byproduct 
Material Incidental to Production and Transfer of Ownership or 
Possession

    This proposed rule would add new Sec.  32.33 to provide the 
requirements to authorize the initial transfer of the products or 
materials for use.

Section 32.34 Items Containing Byproduct Material Incidental to 
Production Safety Criteria

    This proposed rule would add new Sec.  32.34 to provide the safety 
criteria for license applicants.

Section 32.35 Conditions of Licenses Issued Under Sec.  32.33: Quality 
Control, Labeling, and Reports of Transfer

    This proposed rule would add a new Sec.  32.35 to require adequate 
control procedures, labeling, and recordkeeping.

Section 32.303 Criminal Penalties

    This proposed rule would amend paragraph (b) to include new 
Sec. Sec.  32.33 and 32.34 as conforming changes.

V. Regulatory Flexibility Certification

    The NRC has prepared a draft regulatory analysis of the impact of 
this proposed rule. This proposed rule would affect approximately 27 
current and expected licensees that manufacture and/or distribute items 
containing byproduct material incidental to production, some of which 
may qualify as small business entities as defined by Sec.  2.810, ``NRC 
size standards.'' On the basis of the draft regulatory analysis 
conducted for this action, the estimated averted cost of this proposed 
rule for affected licensees is $40,000 (calculated using a 7 percent 
discount rate). Based upon historical data, the NRC estimates that 
approximately 2 out of the 27 estimated licensees subject to this 
rulemaking may qualify as small business entities as defined by Sec.  
2.810. These two small business entities are anticipated to be gemstone 
licensees. It is expected that all businesses will incur the same 
savings resulting from the licensing process. These savings are a small 
percentage of the gross sales; therefore the NRC concludes that there 
would be no significant economic impact to small business entities. The 
NRC believes that the selected alternative reflected in this proposed 
rule is the least costly, most flexible alternative that would 
accomplish the NRC's regulatory objective.
    The NRC is seeking public comment on the potential impact of this 
proposed rule on small entities. The NRC particularly desires comment 
from licensees who qualify as small businesses, specifically as to how 
this proposed regulation would affect them and how the regulation may 
be tiered or otherwise modified to impose less stringent requirements 
on small entities, while still adequately protecting the

[[Page 38016]]

public health and safety and common defense and security. Comments on 
how the regulation could be modified to take into account the differing 
needs of small entities should specifically discuss:
    (1) The size of the business and how the proposed regulation would 
result in a significant economic cost as compared to a larger 
organization in the same business community;
    (2) How the proposed regulation could be further modified to take 
into account the business's differing needs or capabilities;
    (3) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulation was modified as suggested by the 
commenter;
    (4) How the proposed regulation, as modified, would more closely 
equalize the impact of NRC regulations as opposed to providing special 
advantages to any individuals or groups; and
    (5) How the proposed regulation, as modified, would still 
adequately protect the public health and safety and common defense and 
security.
    Comments should be submitted as indicated under the ``Obtaining 
Information and Submitting Comments'' section of this document.

VI. Regulatory Analysis

    The NRC has prepared a draft regulatory analysis on this proposed 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the NRC. The NRC requests public comment on 
the draft regulatory analysis. The regulatory analysis is available as 
indicated in the ``Availability of Documents'' section of this 
document. Comments on the draft analysis may be submitted to the NRC as 
indicated under the ``Obtaining Information and Submitting Comments'' 
section of this document.

VII. Backfitting and Issue Finality

    The NRC has determined that the backfitting provisions in 
Sec. Sec.  50.109, 70.76, 72.62, and 76.76, and the issue finality 
provisions in 10 CFR part 52, ``Licenses, Certifications, and Approvals 
for Nuclear Power Plants,'' do not apply to this proposed rule. The 
class of licensees subject to this rulemaking are applicants for a new 
exempt distribution license for items containing byproduct material 
incidental to production or current irradiated gemstone licensees that 
submit an application for a license amendment for a new irradiated 
gemstone exempt distribution license, the application for which is 
submitted after the effective date of this rule. This class of 
licensees would be regulated in accordance with 10 CFR parts 30 and 32. 
As 10 CFR parts 30 and 32 contain no backfitting provisions, and these 
licensees are not within the scope of an NRC regulation that contains a 
backfitting or issue finality provision, this proposed rule is not 
within the scope of the NRC's backfitting and issue finality 
provisions.

VIII. Cumulative Effects of Regulation

    The NRC is following its Cumulative Effects of Regulation (CER) 
process by engaging with external stakeholders throughout this proposed 
rule and related regulatory activities. Opportunity for public comment 
is provided to the public at this proposed rule stage. The NRC is 
issuing the draft guidance for comment along with this proposed rule to 
support more informed external stakeholder feedback. Further, the NRC 
may hold public meetings throughout the rulemaking process. Section XV, 
``Availability of Guidance,'' of this document describes how the public 
can access the draft guidance for which the NRC seeks external 
stakeholder feedback. The NRC is requesting CER feedback on the 
following questions:
    1. In light of any current or projected CER challenges, does the 
proposed rule's effective date provide sufficient time to implement the 
new proposed requirements, including changes to programs, procedures, 
and the facility?
    2. If CER challenges currently exist or are expected, what should 
be done to address them? For example, if more time is required for 
implementation of the new requirements, what period of time is 
sufficient?
    3. Do other (NRC or other agency) regulatory actions (e.g., orders, 
generic communications, license amendment requests, inspection findings 
of a generic nature) influence the implementation of the proposed 
rule's requirements?
    4. Are there unintended consequences? Does the proposed rule create 
conditions that would be contrary to the proposed rule's purpose and 
objectives? If so, what are the unintended consequences, and how should 
they be addressed?
    5. Please comment on the NRC's cost and benefit estimates in the 
regulatory analysis that supports the proposed rule.

IX. 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 
31885). The NRC requests comment on this document with respect to the 
clarity and effectiveness of the language used.

X. National Environmental Policy Act

    The NRC has determined that the proposed Sec.  32.35(b) and (c) in 
this proposed rule are the types of actions described in Sec.  
51.22(c)(3)(ii) and (iii), and neither an environmental impact 
statement nor an environmental assessment has been prepared for the 
proposed amendments because they relate to recordkeeping and reporting 
requirements for initial distributors of items containing byproduct 
material incidental to production to exempt persons.
    An environmental assessment has been prepared for proposed changes 
not covered by the categorical exclusions listed in Sec.  
51.22(c)(3)(ii) and (iii). The Commission has determined under the 
National Environmental Policy Act of 1969, as amended, and the 
Commission's regulations in subpart A of 10 CFR part 51, that this 
rule, if adopted, would not be a major Federal action significantly 
affecting the quality of the human environment, and therefore, an 
environmental impact statement is not required. The basis of this 
determination is as follows: The amendments would amend 10 CFR part 30 
to add a new class exemption from licensing requirements for items 
containing byproduct material incidental to their production and to 
amend 10 CFR part 32 to add new sections for distribution requirements. 
The environmental impacts arising from the changes have been evaluated 
and would not involve any significant environmental impact or 
significant effect on the quality of the human environment. The 
environmental assessment is available as indicated in the 
``Availability of Documents'' section of this document. Comments on the 
environmental assessment may be submitted to the NRC as indicated under 
the ``Obtaining Information and Submitting Comments'' section of this 
document. The NRC has sent a copy of the environmental assessment and 
this proposed rule to every State Liaison Officer and has requested 
comments.

XI. Paperwork Reduction Act

    This proposed rule contains new or amended collections of 
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.). This proposed rule has been submitted to the Office of 
Management and Budget for review and approval of the information 
collections.

[[Page 38017]]

    Type of submission, new or revision: New.
    The title of the information collection: Part 30--Rules of General 
Applicability to Domestic Licensing of Byproduct Material.
    Part 32--Specific Domestic Licenses to Manufacture or Transfer 
Certain Items Containing Byproduct Material.
    How often the collection is required or requested: Every 15 years.
    Who will be required or asked to respond: Applicant applying for an 
initial or renewed distribution and possession license for items 
containing byproduct material incidental to production.
    An estimate of the number of annual responses:
    Part 30: 18 (9 reporting + 9 recordkeepers).
    Part 32: 918 (9 reporting + 9 recordkeepers + 900 third-party 
disclosure).
    The estimated number of annual respondents:
    Part 30: 9.
    Part 32: 9.
    An estimate of the total number of hours needed annually to comply 
with the information collection requirement or request:
    Part 30: 585 (540 reporting hours + 45 recordkeeping hours).
    Part 32: 714 (630 reporting hours + 9 recordkeeping hours + 75 
third-party disclosure hours).
    Abstract: In part 30 of title 10 of the Code of Federal Regulations 
(10 CFR) the NRC regulates the manufacturing, production, transfer, 
receipt, acquisition, ownership, possession, and use of byproduct 
material. Part 32 of 10 CFR provides requirements for the issuance of 
specific licenses to persons who manufacture or initially transfer 
items containing byproduct material for sale or distribution. This 
proposed rule would amend 10 CFR part 30 to add a new class exemption 
from licensing requirements for items containing byproduct material 
incidental to their production and amend 10 CFR part 32 to add new 
sections for distribution requirements.
    The U.S. Nuclear Regulatory Commission is seeking public comment on 
the potential impact of the information collection(s) contained in this 
proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of the burden of the proposed information 
collection accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the proposed information collection on 
respondents be minimized, including the use of automated collection 
techniques or other forms of information technology?
    A copy of the Office of Management and Budget (OMB) clearance 
package and proposed rule is available in ADAMS or can be obtained free 
of charge by contacting the NRC's Public Document Room reference staff 
at 1-800-397-4209, at 301-415-4737, or by email to 
[email protected]. You may obtain information and comment 
submissions related to the OMB clearance package by searching on 
https://www.regulations.gov under Docket ID NRC-2015-0017.
    You may submit comments on any aspect of these proposed information 
collection(s), including suggestions for reducing the burden and on the 
above issues, by the following methods:
     Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0017.
     Mail comments to: FOIA, Library, and Information 
Collections Branch, Office of the Chief Information Officer, Mail Stop: 
T6-A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 
or to the OMB reviewer at: OMB Office of Information and Regulatory 
Affairs (3150-0017 and 3150-0001), ATTN: Desk Officer for the Nuclear 
Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email: 
[email protected].
    Submit comments by July 27, 2022. 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.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless the document requesting 
or requiring the collection displays a currently valid OMB control 
number.

XII. Criminal Penalties

    For the purposes of Section 223 of the Atomic Energy Act of 1954, 
as amended (AEA), the NRC is issuing this proposed rule that would 
amend 10 CFR parts 30 and 32 under one or more of Sections 161b, 161i, 
or 161o of the AEA. Willful violations of this rule would be subject to 
criminal enforcement. Criminal penalties as they apply to regulations 
in 10 CFR parts 30 and 32 are discussed in Sec. Sec.  30.64 and 32.303, 
respectively.

XIII. Coordination With Agreement States

    The working group involved in the preparation of this proposed rule 
included two representatives from the Organization of Agreement States. 
Early drafts of this proposed rule were provided to Agreement States 
for review. Comments from Agreement States were taken into 
consideration during the development of this proposed rule.

XIV. Compatibility of Agreement State Regulations

    Under the ``Agreement State Program Policy Statement'' approved by 
the Commission on October 2, 2017, and published in the Federal 
Register on October 18, 2017 (82 FR 48535), NRC program elements 
(including regulations) are placed into compatibility categories A, B, 
C, D, NRC, or adequacy category Health and Safety (H&S). Compatibility 
Category A are those program elements that include basic radiation 
protection standards and scientific terms and definitions that are 
necessary to understand radiation protection concepts. An Agreement 
State should adopt Category A program elements in an essentially 
identical manner in order to provide uniformity in the regulation of 
agreement material on a nationwide basis. Compatibility Category B 
pertains to a limited number of program elements that cross 
jurisdictional boundaries and should be addressed to ensure uniformity 
of regulation on a nationwide basis. An Agreement State should adopt 
Category B program elements in an essentially identical manner. 
Compatibility Category C are those program elements that do not meet 
the criteria of Category A or B, but the essential objectives of which 
an Agreement State should adopt to avoid conflict, duplication, gaps, 
or other conditions that would jeopardize an orderly pattern in the 
regulation of agreement material on a national basis. An Agreement 
State should adopt the essential objectives of the Category C program 
elements. Compatibility Category D are those program elements that do 
not meet any of the criteria of Category A, B, or C above, and thus, do 
not need to be adopted by Agreement States for purposes of 
compatibility. Compatibility Category NRC are those program elements 
that address areas of regulation that cannot be relinquished to the 
Agreement States under the Atomic Energy Act of 1954, as amended (AEA), 
or provisions of title 10 of the Code of Federal Regulations. These 
program elements should not be adopted by the Agreement States.

[[Page 38018]]

Category H&S program elements are not required for purposes of 
compatibility; however, they do have particular health and safety 
significance. The Agreement State should adopt the essential objectives 
of such program elements to maintain an adequate program.
    The proposed rule would be a matter of compatibility between the 
NRC and the Agreement States, thereby providing consistency among 
Agreement State and NRC requirements. The compatibility categories are 
designated in the following table:

                                               Compatibility Table
----------------------------------------------------------------------------------------------------------------
                                                                                     Compatibility
        Section                  Change                Subject       -------------------------------------------
                                                                            Existing                 New
----------------------------------------------------------------------------------------------------------------
                                                     Part 30
----------------------------------------------------------------------------------------------------------------
30.23..................  New...................  Items containing     ....................  B.
                                                  byproduct material
                                                  incidental to
                                                  production.
----------------------------------------------------------------------------------------------------------------
                                                     Part 32
----------------------------------------------------------------------------------------------------------------
32.33..................  New...................  Requirements for     ....................  NRC.
                                                  license of items
                                                  containing
                                                  byproduct material
                                                  incidental to
                                                  production and
                                                  transfer of
                                                  ownership or
                                                  possession.
32.34..................  New...................  Items containing     ....................  NRC.
                                                  byproduct material
                                                  incidental to
                                                  production safety
                                                  criteria.
32.35..................  New...................  Conditions of        ....................  NRC.
                                                  licenses issued
                                                  under Sec.
                                                  32.33: Quality
                                                  control, labeling,
                                                  and reports of
                                                  transfer.
32.303.................  Amend.................  Criminal penalties.  D                     D.
----------------------------------------------------------------------------------------------------------------

XV. Availability of Guidance

    The NRC is issuing draft guidance in conjunction with this proposed 
rule. The draft guidance is intended for use by applicants, licensees, 
Agreement States, and the NRC when preparing and evaluating an exempt 
distribution licensing action for items containing byproduct material 
incidental to production. These exempt distribution licenses will 
authorize the initial distribution of byproduct material incidental to 
production to persons exempt from the regulatory requirements (exempt 
distribution) for an NRC license under 10 CFR part 30 and exempt from 
licensing requirements under the equivalent provisions in Agreement 
State regulations.
    The draft guidance document reflects the provisions in this 
proposed rule. Comments on the draft guidance may be submitted by the 
methods provided in Section I, ``Obtaining Information and Submitting 
Comments,'' of this document. The draft guidance is available as 
indicated under the ``Availability of Documents'' section of this 
document. The NRC plans to incorporate the final guidance into the next 
comprehensive revision of NUREG-1556, Volume 8, ``Consolidated Guidance 
About Materials Licenses: Program-Specific Guidance About Exempt 
Distribution Licenses.''

XVI. Public Meeting

    The NRC will publish a notice of the location, time, and agenda of 
the meeting on https://www.regulations.gov, and on the NRC's public 
meeting website within at least 10 calendar days before the meeting. 
Stakeholders should monitor the NRC's public meeting website for 
information about the public meeting at: https://www.nrc.gov/public-involve/public-meetings/index.cfm.

XVII. Availability of Documents

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

------------------------------------------------------------------------
                                    ADAMS accession No./web link/Federal
             Document                        Register citation
------------------------------------------------------------------------
Draft Guidance Document to NUREG-  ML21256A291.
 1556, Volume 8, Revision 1,
 ``Consolidated Guidance About
 Materials Licenses: Program-
 Specific Guidance About Exempt
 Distribution Licenses,'' dated
 June 2020.
Federal Register notification for  86 FR 7819.
 the Regulatory Basis for this
 Proposed Rule, published
 February 2, 2021.
Regulatory Analysis..............  ML22160A404.
Environmental Assessment.........  ML22160A406.
Federal Register notification for  77 FR 56793.
 PRM-30-65 Docket Closure [NRC-
 2011-0134], published September
 14, 2012.
Federal Register notification for  76 FR 36386.
 PRM-30-65 Receipt and Request
 for Comment [NRC-2011-0134],
 published June 22, 2011.
NRC Agreement State Program        82 FR 48535.
 Policy Statement, published
 October 18, 2017.
Presidential Memorandum, ``Plain   63 FR 31885.
 Language in Government
 Writing,'' published June 10,
 1998.
GE Osomics--Polymer Track Etch     ML120800277.
 Membrane 10 CFR 32.1--
 Manufacture and Distribution
 Product Safety Information,
 March 20, 2012.
SECY-87-186A, ``Distribution of    ML092400170.
 Radioactive Gems Irradiated in
 Reactors to Unlicensed Persons
 (Follow-up to SECY-87-186),''
 October 5, 1987.
Regulatory Basis for Items         ML20339A312 (package).
 Containing Byproduct Material
 Incidental to Production.
OMB Clearance Package, June 2020.  ML21256A288.
------------------------------------------------------------------------

    Throughout the development of this rule, the NRC may post documents 
related to this rule, including public comments, on the Federal 
rulemaking website at https://www.regulations.gov under Docket ID NRC-
2015-0017. In addition, the Federal rulemaking website allows members 
of the public 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 ``Subscribe'' link; and 3) enter an email address 
and click on the ``Subscribe'' link.

[[Page 38019]]

List of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear energy, Nuclear 
materials, Penalties, Radiation protection, Reporting and recordkeeping 
requirements, Whistleblowing.

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear energy, 
Nuclear materials, Radiation protection, Reporting and recordkeeping 
requirements.

    For the reasons set out in the preamble and under the authority of 
the AEA; the Energy Reorganization Act of 1974, as amended; and 5 
U.S.C. 552 and 553, the NRC proposes to amend 10 CFR parts 30 and 32 as 
follows:

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

0
1. The authority citation for part 30 continues to read as follows:

    Authority:  Atomic Energy Act of 1954, secs. 11, 81, 161, 181, 
182, 183, 184, 186, 187, 223, 234, 274 (42 U.S.C. 2014, 2111, 2201, 
2231, 2232, 2233, 2234, 2236, 2237, 2273, 2282, 2021); Energy 
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 
5841, 5842, 5846, 5851); 44 U.S.C. 3504 note.

0
2. Add Sec.  30.23 to read as follows:


Sec.  30.23   Items containing byproduct material incidental to 
production.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution items containing byproduct 
material that is incidental to production and except as provided in 
paragraphs (e) and (f) of this section, any person is exempt from the 
requirements for a license set forth in section 81 of the Act.
    (b) For persons exempt under paragraph (a) of this section, they 
are also exempt from parts 20, 30 through 36, and 39 of this chapter to 
the extent that such person receives, possesses, uses, transfers, owns, 
or acquires items containing byproduct material incidental to 
production.
    (c) A specific license issued under 10 CFR 32.33, which authorizes 
the initial transfer of the products or materials for use under this 
section, is needed to manufacture, process, produce, or initially 
transfer items containing byproduct material incidental to production.
    (d) This section may not be deemed to authorize the import of 
byproduct items containing byproduct material incidental to production.
    (e) The exemption in this section does not apply to the transfer of 
byproduct material contained in any food, beverage, cosmetic, drug, or 
other commodity or product that is designed to be, or could reasonably 
be expected to be, ingested, inhaled, or absorbed by, or applied to, a 
human being.
    (f) No person may introduce byproduct material incidental to 
production into a product or material knowing, or having reason to 
believe, that it will be transferred to persons exempt under this 
section or equivalent regulations of an Agreement State, except in 
accordance with a license issued under 10 CFR 32.33.

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

0
3. The authority citation for part 32 continues to read as follows:

    Authority:  Atomic Energy Act of 1954, secs. 81, 161, 170H, 181, 
182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2210h, 2231, 2232, 
2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, sec. 201 
(42 U.S.C. 5841); 44 U.S.C. 3504 note.

0
4. Add Sec. Sec.  32.33, 32.34, and 32.35 to subpart B to read as 
follows:


Sec.  32.33   Requirements for license of items containing byproduct 
material incidental to production and transfer of ownership or 
possession.

    (a) An application for a specific license to manufacture, process, 
or produce items containing byproduct material that is incidental to 
production, or to initially transfer for sale or distribution such 
items under 10 CFR 30.23 or equivalent regulations of an Agreement 
State, will be approved if:
    (1) The applicant satisfies the general requirements specified in 
10 CFR 30.33, provided that an application for a license to transfer 
items containing byproduct material that is incidental to production 
does not need to meet the requirements of 10 CFR 30.33(a)(2) and (3) 
for items manufactured, processed, or produced under a license issued 
by an Agreement State.
    (2) The applicant submits sufficient information relating to the 
design; manufacture; prototype testing; quality control procedures; 
labeling or marking; and conditions of handling, storage, use, and 
disposal of the item containing byproduct material that is incidental 
to production to demonstrate that the product will meet the safety 
criteria set forth in Sec.  32.34. The information must include:
    (i) A description of the item and its intended use or uses.
    (ii) The type and quantity of byproduct material in each unit.
    (iii) Chemical and physical form of the byproduct material in the 
item and changes in chemical and physical form that may occur during 
the useful life of the product.
    (iv) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (a)(2)(iii) and (xii) of 
this section.
    (v) Details of construction and design of the item as related to 
safety features under normal and severe conditions of handling, 
storage, use, and disposal of the item.
    (vi) Maximum external radiation levels at 5 and 25 centimeters from 
any external surface of the product, averaged over an area not to 
exceed 10 square centimeters, and the method of measurement.
    (vii) Degree of access of human beings to the item during normal 
handling and use.
    (viii) Total quantity of byproduct material expected to be 
distributed in the items annually.
    (ix) The expected useful life of the item.
    (x) The proposed method of labeling or marking each point of sale 
package and, if feasible, each unit. Each mark or label must contain 
the statement ``CONTAINS RADIOACTIVE MATERIAL'' and must identify the 
initial transferor of the item.
    (xi) Procedures for prototype testing of the item to demonstrate 
the effectiveness of the safety features under both normal and severe 
conditions of handling, storage, use, and disposal of the product.
    (xii) Results of the prototype testing of the item, including any 
change in the form of the byproduct material contained in the product, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features.
    (xiii) The estimated external radiation doses and committed dose 
resulting from the intake of radioactive material in any one year 
relevant to the safety criteria in Sec.  32.34 and the basis for such 
estimates.
    (xiv) A determination that the probabilities with respect to the 
doses referred to in Sec.  32.34 meet the criteria set forth in Sec.  
32.34.
    (xv) Quality control procedures to be followed in the fabrication 
of production lots of the product and the quality control standards the 
product will be required to meet.

[[Page 38020]]

    (xvi) Any additional information, including experimental studies 
and tests, requested by the Commission.
    (3) The Commission determines that the product meets the safety 
criteria in Sec.  32.34.
    (b) Notwithstanding the provisions of paragraph (a) of this 
section, the Commission may deny an application for a specific license 
under this section if the end uses of the product cannot be reasonably 
foreseen.


Sec.  32.34   Items containing byproduct material incidental to 
production safety criteria.

    (a) An applicant for a license under Sec.  32.33 must demonstrate 
that the item is designed and will be manufactured so that:
    (1) In normal use, normal handling, and normal storage of the 
quantities of exempt items likely to accumulate in one location, 
including during marketing, distribution, installation, and/or 
servicing of the item, it is unlikely that:
    (i) The external radiation dose in any one year, or the committed 
dose resulting from the intake of radioactive material in any one year, 
to a suitable sample of the group of individuals expected to be most 
highly exposed to radiation or radioactive material from the item will 
exceed 50 [mu]Sv (5 mrem); and
    (ii) There will be a significant reduction in the effectiveness of 
the safety features of the item from wear and abuse.
    (2) In disposal of quantities of exempt items likely to accumulate 
in the same disposal site, it is unlikely that the external radiation 
dose in any one year, or the committed dose resulting from the intake 
of radioactive material in any one year, to a suitable sample of the 
group of individuals expected to be most highly exposed to radiation or 
radioactive material, will exceed 10 [mu]Sv (1 mrem).
    (3) In use, handling, storage, and disposal of the quantities of 
exempt products likely to accumulate in one location, including during 
marketing, distribution, installation, and/or servicing of the item, 
the probability is low that the safety features of the item would fail 
under such circumstances that a person would receive an external 
radiation dose or committed dose in excess of 5 mSv (500 mrem), and the 
probability is negligible that a person would receive an external 
radiation dose or committed dose of 100 mSv (10 rem) or greater.\1\
---------------------------------------------------------------------------

    \1\ Paragraph (a)(3) of this section assumes that as the 
magnitude of the potential dose increases above that permitted under 
normal conditions, the probability that any individual will receive 
such a dose must decrease. The probabilities have been expressed in 
general terms to emphasize the approximate nature of the estimates 
that are to be made. The following values may be used as guides in 
estimating compliance with the criteria: Low--not more than one such 
failure/incident per year for each 10,000 exempt units distributed. 
Negligible--not more than one such failure/incident per year for 
each one million exempt units distributed.
---------------------------------------------------------------------------

    (b) An applicant for a license under Sec.  32.33 must demonstrate 
that, even in unlikely scenarios of misuse, including those resulting 
in direct exposure to the item for 1,000 hours at an average distance 
of 1 meter and those resulting in dispersal and subsequent intake of 
10-4 of the quantity of byproduct material (or in the case 
of tritium, an intake of 10 percent), a person will not receive an 
external radiation dose or committed dose in excess of 100 mSv (10 
rem), and, if item is small enough to fit in a pocket, that the dose to 
localized areas of skin averaged over areas no larger than 1 square 
centimeter from carrying the item in a pocket for 80 hours will not 
exceed 2 Sv (200 rem).


Sec.  32.35   Conditions of licenses issued under Sec.  32.33: Quality 
control, labeling, and reports of transfer.

    Each person licensed under Sec.  32.33 must:
    (a) Carry out adequate control procedures in the manufacture of the 
item to assure that each item meets the quality control standards 
approved by the Commission;
    (b) Label or mark each point of sale package and, if feasible, each 
unit. Each mark or label must contain the statement ``CONTAINS 
RADIOACTIVE MATERIAL'' and must identify the initial transferor of the 
item; and
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Nuclear Material Safety and Safeguards by an 
appropriate method listed in 10 CFR 30.6(a), including in the address: 
ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the items are transferred for use 
under 10 CFR 30.16 or equivalent regulations of an Agreement State.
    (3) The report must include the following information on items 
transferred to other persons for use under 10 CFR 30.16 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each item and 
the model number(s); and
    (ii) The number of units of each type of product transferred during 
the reporting period by model number.
    (4)(i) The report, covering the preceding calendar year, must be 
filed on or before January 31 of each year. The licensee must 
separately include data for transfers in prior years not previously 
reported to the Commission.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.33 must file a report for the current 
calendar year within 30 calendar days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under 
Sec.  32.33 during the reporting period, the report must so indicate.
    (6) The licensee must maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.


Sec.  32.303   [Amended]

0
5. In Sec.  32.303, amend paragraph (b) by adding the references 
``32.33, 32.34,'' in sequential order.

    Dated June 21, 2022.

    For the Nuclear Regulatory Commission.
Brooke P. Clark,
Secretary of the Commission.
[FR Doc. 2022-13599 Filed 6-24-22; 8:45 am]
BILLING CODE 7590-01-P