38012 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Proposed Rules 

on State and local governments. 

Therefore, under Section 6(b) of the 

Executive order, a federalism summary 

impact statement is not required. 

Executive Order 12988, Civil Justice 

Reform 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule is intended to 

have preemptive effect with respect to 

any State or local laws, regulations or 

policies which conflict with its 

provisions or which would otherwise 

impede its full and timely 

implementation. This rule is not 

intended to have retroactive effect 

unless so specified in the Effective Dates 

section of the final rule. Prior to any 

judicial challenge to the provisions of 

the final rule, all applicable 

administrative procedures must be 

exhausted. 

Civil Rights Impact Analysis 

FNS has reviewed the proposed rule, 

in accordance with Department 

Regulation 4300–004, Civil Rights 

Impact Analysis, to identify and address 

any major civil rights impacts the rule 

might have on minorities, women, and 

persons with disabilities. The changes 

to SNAP regulations in this proposed 

rule are to remove third party visual 

observation for race and ethnicity data 

collection from SNAP regulations. After 

careful review of the rule’s intent and 

provisions, FNS believes that the 

promulgation of this rule will increase 

the accuracy of data collected on the 

race and ethnicity of SNAP households 

by reducing errors in data collection 

caused by inaccurate visual observation. 

While this rule does provide for the 

collection of racial and ethnic data of 

SNAP households, as required by 

Federal law, it does not change any 

eligibility criteria. 

Executive Order 13175 

Executive Order 13175 requires 

Federal agencies to consult and 

coordinate with Tribes on a 

government-to-government basis on 

policies that have Tribal implications, 

including regulations, legislative 

comments or proposed legislation, and 

other policy statements or actions that 

have substantial direct effects on one or 

more Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

We are unaware of any current Tribal 

laws that could be in conflict with this 

rule. 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. Chap. 35; 5 CFR part 1320) 

requires OMB approve all collections of 

information by a Federal agency before 

they can be implemented. Respondents 

are not required to respond to any 

collection of information unless it 

displays a current valid OMB control 

number under the Paperwork Reduction 

Act of 1995. 

Information collection activities 

associated with this rule are approved 

under existing OMB Control Numbers. 

OMB Control Number 0584–0064 

(expiration 02/29/2024) includes burden 

estimates associated with the collection 

of race and ethnicity data on SNAP 

applications. OMB Control Number 

0584–0594 (expiration 07/31/2023) 

includes burden estimates associated 

with race and ethnicity data reporting 

on the form FNS–101, ‘‘Participation in 

Food Programs—byRace’’. The proposed 

changes in this rule do not introduce 

any new or changed information 

collection requirements subject to 

approval by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995. 

E-Government Act Compliance 

The Department is committed to 

complying with the E-Government Act 

of 2002, to promote the use of the 

internet and other information 

technologies to provide increased 

opportunities for citizen access to 

Government information and services, 

and for other purposes. 

List of Subjects in 7 CFR Part 272 

Civil rights, Claims, Grant programs— 

social programs, Reporting and 

recordkeeping requirements, 

Unemployment compensation, Wages. 

Accordingly, 7 CFR part 272 is 

amended as follows: 

PART 272—REQUIREMENTS FOR 

PARTICIPATING STATE AGENCIES 

■ 1. The authority citation for part 272 

continues to read as follows. 

Authority: 7 U.S.C. 2011–2036. 

■ 2. In § 272.6, revise the third sentence 

in paragraph (g) to read as follows: 

§ 272.6 Nondiscrimination compliance. 

* * * * * 

(g) * * * The State agency must 

develop alternative means of collecting 

the ethnic and racial data on households 

when the information is not provided 

voluntarily by the household on the 

application form. 

* * * * * 

Cynthia Long, 

Administrator, Food and Nutrition Service. 

[FR Doc. 2022–13058 Filed 6–24–22; 8:45 am] 

BILLING CODE 3410–30–P 

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. 

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: Dawn.Forder@nrc.gov. For 

technical questions contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 


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• Email comments to: 

Rulemaking.Comments@nrc.gov. 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: Shirley.Xu@nrc.gov; and Caylee 

Kenny, telephone: 301–415–7150; 

email: Caylee.Kenny@nrc.gov. 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 

pdr.resource@nrc.gov. 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 PDR.Resource@

nrc.gov 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 § 30.11, ‘‘Specific 

exemptions,’’ through § 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 

§ 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. 


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Both §§ 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 § 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 § 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 gammaemitting byproduct material with a halflife 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 strontium90 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 §§ 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 § 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 

§ 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 § 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 

§ 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 §§ 30.19, 

‘‘Self-luminous products containing 

tritium, krypton-85, or promethium147’’; 30.20, ‘‘Gas and aerosol detectors 

containing byproduct material’’; and 

30.22, ‘‘Certain industrial devices.’’ This 

planned rulemaking approach is similar 

to that for §§ 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 §§ 32.23, ‘‘Same [Self-luminous 


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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 (mSv)/year) except for disposal 

scenarios for which the criterion is 1 mrem/year (10 

mSv/year), because the same individuals could be 

impacted by all of the products allowed to be 

disposed in landfills and municipal incinerators. 

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 

(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 

§ 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 

§ 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 

§ 32.34 to provide the safety criteria for 

license applicants. 

Section 32.35 Conditions of Licenses 

Issued Under § 32.33: Quality Control, 

Labeling, and Reports of Transfer 

This proposed rule would add a new 

§ 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 §§ 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 

§ 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 § 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 


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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 §§ 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 § 32.35(b) and (c) in this 

proposed rule are the types of actions 

described in § 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 § 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. 


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Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Proposed Rules 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 PDR.resource@nrc.gov. 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: oira_submission@omb.eop.gov. 

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 

§§ 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. 


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38018 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Proposed Rules 

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

Section Change Subject 

Compatibility 

Existing New 

Part 30 

30.23 .............. New ................ Items containing byproduct material incidental to production ............................ B. 

Part 32 

32.33 .............. New ................ Requirements for license of items containing byproduct material incidental to 

production and transfer of ownership or possession.

NRC. 

32.34 .............. New ................ Items containing byproduct material incidental to production safety criteria ..... NRC. 

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

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/publicinvolve/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. 

Document 

ADAMS accession No./web 

link/Federal Register citation 

Draft Guidance Document to NUREG–1556, Volume 8, Revision 1, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses,’’ dated June 2020.ML21256A291. 

Federal Register notification for the Regulatory Basis for this Proposed Rule, published February 2, 2021 ............. 86 FR 7819. 

Regulatory Analysis ........................................................................................................................................................ ML22160A404. 

Environmental Assessment ............................................................................................................................................ ML22160A406. 

Federal Register notification for PRM–30–65 Docket Closure [NRC–2011–0134], published September 14, 2012 .. 77 FR 56793. 

Federal Register notification for PRM–30–65 Receipt and Request for Comment [NRC–2011–0134], published 

June 22, 2011.

76 FR 36386. 

NRC Agreement State Program Policy Statement, published October 18, 2017 ......................................................... 82 FR 48535. 

Presidential Memorandum, ‘‘Plain Language in Government Writing,’’ published June 10, 1998 ................................ 63 FR 31885. 

GE Osomics—Polymer Track Etch Membrane 10 CFR 32.1—Manufacture and Distribution Product Safety Information, March 20, 2012.ML120800277. 

SECY–87–186A, ‘‘Distribution of Radioactive Gems Irradiated in Reactors to Unlicensed Persons (Follow-up to 

SECY–87–186),’’ October 5, 1987.

ML092400170. 

Regulatory Basis for Items Containing Byproduct Material Incidental to Production .................................................... ML20339A312 (package). 

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. 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Proposed Rules 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 

■ 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. 

■ 2. Add § 30.23 to read as follows: 

§ 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 

■ 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. 

■ 4. Add §§ 32.33, 32.34, and 32.35 to 

subpart B to read as follows: 

§ 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 § 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 § 32.34 and the basis for such 

estimates. 

(xiv) A determination that the 

probabilities with respect to the doses 

referred to in § 32.34 meet the criteria 

set forth in § 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. 


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38020 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Proposed Rules 

1Paragraph (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. 

(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 

§ 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. 

§ 32.34 Items containing byproduct 

material incidental to production safety 

criteria. 

(a) An applicant for a license under 

§ 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 mSv (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 mSv 

(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

(b) An applicant for a license under 

§ 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). 

§ 32.35 Conditions of licenses issued 

under § 32.33: Quality control, labeling, and 

reports of transfer. 

Each person licensed under § 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 § 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 § 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. 

§ 32.303 [Amended] 

■ 5. In § 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 

DEPARTMENT OF ENERGY 

Federal Energy Regulatory 

Commission 

18 CFR Part 40 

[Docket No. RM22–10–000] 

Transmission System Planning 

Performance Requirements for 

Extreme Weather 

AGENCY: Federal Energy Regulatory 

Commission, Department of Energy. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Federal Energy 

Regulatory Commission proposes to 

direct that the North American Electric 

Reliability Corporation, the 

Commission-certified Electric 

Reliability Organization, submit to the 

Commission modifications to Reliability 

Standard TPL–001–5.1 (Transmission 

System Planning Performance 

Requirements) within one year of the 

effective date of a final rule in this 

proceeding to address reliability 

concerns pertaining to transmission 

system planning for extreme heat and 

cold weather events that impact the 

reliable operations of the Bulk-Power 


jspears on DSK121TN23PROD with PROPOSALS1