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ACTION: Proposed rule and draft guidance; request for comment.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