VR-SECY-22-0112, Proposed Rule: Radioactive Source Security and Accountability (3150-AK83; NRC-2022-0103) (Crowell)

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VR-SECY-22-0112: Proposed Rule: Radioactive Source Security and Accountability (3150-AK83; NRC-2022-0103) (Crowell)
ML24045A190
Person / Time
Issue date: 05/01/2023
From: Crowell B
NRC/OCM
To: Carrie Safford
NRC/SECY
Shared Package
ML24045A185 List:
References
SECY-22-0112 VR-SECY-22-0112
Download: ML24045A190 (1)


Text

RULEMAKING ISSUE NOTATION VOTE

RESPONSE SHEET

TO: Brooke P. Clark, Secretary FROM: Commissioner Crowell

SUBJECT:

SECY-22-0112: Radioactive Source Security and Accountability Rulemaking (Docket ID No. NRC-2022 -

0103; RIN No. 3150-AK83)

Approved X Disapproved Abstain Not Participating

COMMENTS: Below X Attached X None

I approve issuance of the proposed rule for publication in the Federal Register, subject to the attached edits. I appreciate the staffs efforts to provide this rule on an accelerated schedule, while also engaging Agreement States and the Advisory Committee on the Medical Uses of Isotopes. I believe the proposed rule appropriately addresses existing vulnerabilities with the National Materials Program, including those highlighted by the U.S. General Accountability Office in their reports from 2016 and 2022. I appreciate the input provided by the Low Level Waste Forum requesting that the proposed rule include requirements for the specific licensing of existing generally-licensed Category 3 devices and quantities of materials. However, given the relatively small numbers of these devices and annual registration requirements, I agree with the staffs conclusion that requiring the current users of these devices to obtain specific licensees is unwarranted.

Entered in STAR Yes X Signature

No BRC edits

[7590-01-P]

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 31, 32, 40, and 70

[NRC-2022-0103]

RIN 3150-AK83

Radioactive Source Security and Accountability

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its

regulations to further ensure validity of license applicants. This proposed rule also would

enhance the requirement for a licensee transferring category 3 quantities of radioactive

material to verify that the recipient (transferee) is licensed to receive the type, form, and

quantity of radioactive material to be transferred. This proposed rule would require the

transferor licensee to conduct the verification through the NRCs License Verification

System or by contacting the license-issuing authority. The NRC also is proposing a

more stringent follow-up verification method for licensees that process an emergency

shipment for transfers that are below category 2 quantities of radioactive material and to

remove an obsolete verification method. In addition, the proposed rule would require

that generally licensed devices containing category 3 quantities of byproduct material

can only be transferred to licensees possessing a specific NRC or Agreement State

license. Finally, the proposed rule would make conforming and other clarifying changes

of a corrective or of a minor or nonpolicy nature (e.g., inclusive language, plain language, conforming and clarifying language, and reassignment and deletion of

paragraphs). This rulemaking would affect applicants for a radioactive material license,

as well as licensees who transfer category 3 quantities of radioactive material. The NRC

will hold a public meeting during the comment period to promote full understanding of

the proposed rule and facilitate public comments.

DATES: Submit comments by [INSERT DATE 75 DAYS AFTER DATE OF

PUBLICATION IN THE FEDERAL REGISTER]. 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-2022-0103. Address questions about NRC dockets to Dawn Forder;

telephone: 301-415-3407; email: Dawn.Forder@nrc.gov. For technical questions

contact the individuals listed in the FO R FURTHER INFORMATION CONTACT section

of this document.

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 2

Obtaining Information and Submitting Comments in the SUPPLEMENTARY

INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Anita Gray, Office of Nuclear Material

Safety and Safeguards, telephone: 301-415-7036, email: Anita.Gray@nrc.gov and

Andrew Carrera, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-

1078, email: Andrew.Carrera@nrc.gov. Both are staff of the 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 III. Discussion IV. Specific Requests for Comments V. Section-by-Section Analysis VI. Regulatory Flexibility Certification VII. Regulatory Analysis VIII. Backfitting and Issue Finality IX. Cumulative Effects of Regulation X. Plain Writing XI. Draft Environmental Assessment and Draft Finding of No Significant Environmental Impact XII. Paperwork Reduction Act Statement XIII. Criminal Penalties XIV. Coordination with NRC Agreement States XV. Coordination with the Advisory Committee on the Medical Uses of Isotopes XVI. Compatibility of Agreement State Regulations XVII. Voluntary Consensus Standards XVIII. Availability of Guidance XIX. Public Meeting XX. Availability of Documents

3 I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC-2022-0103 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-2022-0103.

NRCs 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 NRCs Public Document Room (P DR) 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.

NRCs PDR: You may examine and purchase copies of public documents,

by appointment, at the NRCs 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. eastern time (ET), Monday through Friday,

except Federal holidays.

B. Submitting Comments 4

The NRC encourages electronic comment submission through the Federal

rulemaking website (https://www.regulations.gov). Please include Docket ID NRC-2022-

0103 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.regulat ions.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

The NRC and its Agreement State1 partners have implemented a robust

regulatory framework tothat ensures the safety, security, and control of radioactive

materials used for civilian purposes in the United States. 2 All licensed radioactive

1 Section 274 of the Atomic Energy Act of 1954, as amended, authorizes the NRC to relinquish or discontinue its regulatory authority over certain categories of radioactive material to a State following a duly executed agreement between the NRC and the governor of the State. 42 U.S.C. 2021. After the agreement is entered into, the State, now an Agreement State, must issue or adopt regulations compatible to those NRC regulations that govern the subject matter areas relinquished to the Agreement State. A State that has not entered into a Section 274 agreement is referred to as a non-Agreement State.

2 For details regarding the types of materials regulated by the NRC, see Regulation of Radioactive Materials at https://www.nrc.gov/about-nrc/radiation/protects-you/reg-matls.html.

5 materialssources are subject to physical protection requirements appropriate to the

relative risk they pose to safety and security. In addition, the NRC implements the

International Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security

of Radioactive Sources (Code of Conduct).3 The Code of Conduct provides guidance for

the safety and security for three categories of radioactive sources; the highest risk

sources are those defined as category 1 and category 2. 4 As defined in the Code of

Conduct, category 3 sources, if not safely managed or securely protected, could cause

permanent injury to a person who handled them, or was otherwise in contact with them,

for some hours. Individual cCategory 3 sources are considered to be less dangerous

than category 1 and category 2 sources.

The NRC has developed a suite of informati on technology tools that it uses to

conduct materials licensing, oversight, and r adioactive source accountability. The key

systems used by the NRC and Agreement State materials programs are the National

Source Tracking System (NSTS), the Web-Based Licensing (WBL) System, and the

License Verification System (LVS). The NSTS is a secure online national registry used

to track category 1 and category 2 radioactive sources. Category 3 radioactive sources

are not included in the NSTS 5. The WBL is a materials licensing system and provides a

single platform for the NRC and participating Agreement States 6 to use to manage the

licensing information of entities that are authorized to possess or use radioactive

3 https://www.iaea.org/topics/codes-of-conduct 4 Category 1 and category 2 quantities of radioactive material are defined as those meeting the thresholds defined in both the IAEA Code of Conduct on the Safety and Security of Radioactive Sources and in appendix A to part 37 of title 10 of the Code of Federal Regulations (10 CFR), Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.

5 In the staff requirements memorandum (SRM) SRM-SECY-17-0083, Re-Evaluation of Category 3 Source Security and Accountability in Response to SRM-COMJMB-16-0001, dated December 21, 2021 (ADAMS Accession No. ML21355A290), the Commission approved the staffs recommendation not to amend the regulations to require inclusion of category 3 sources in the NSTS.

6 Agreement States can elect to use WBL or their own system to manage their licensing information.

6 materials. The LVS enables licensees who have been credentialed for system access to

verify certain information about licensees authorized to possess, use, or transport

radioactive materials. The LVS allows, but does not require, licensees to confirm, prior

to transferring radioactive material to another licensee, that the recipients license 1) is

valid and accurate and 2) authorizes the recipient to possess the type, form, and

quantity of radioactive materials being requested.

In recent years, the NRC and Agreement States have considered whether the

radioactive source security and accountability infrastructure could be strengthened for

category 3 quantities of radioactive materials. On October 18, 2016, in the SRM for

COMJMB-16-0001, Proposed Staff Re-Evaluation of Category 3 Source Accountability

(ADAMS Accession No. ML16292A812), the Commission directed the NRC staff to take

specific actions to evaluate whether it is necessary to revise the NRC regulations or

processes governing source protection and accountability for category 3 sources to

continue to ensure adequate protection of public health and safety. The NRC and

Agreement States formed a joint working group and shared its recommendations with

the Commission in SECY-17-0083, Re-evaluation of Category 3 Source Security and

Accountability in Response to SRM-COMJMB-16-0001 (ADAMS Accession No.

ML17188A255). In SECY-17-0083, the NRC staffs recommendations included

amending 10 CFR part 30, Rules of General Applicability to Domestic Licensing of

Byproduct Material, 10 CFR part 40, Domestic Licensing of Source Material, and 10

CFR part 70, Domestic Licensing of Special Nuclear Material, to address the concern

that a person might obtain a valid license or radioactive materials by using a fictitious

company or providing false information.

In SRM-SECY-17-0083, Re-Evaluation of Category 3 Source Security and

Accountability in Response to SRM-COMJMB-16-0001, dated December 21, 2021 7

(ADAMS Accession No. ML21355A290), the Commission addressedapproved the NRC

staffs recommendations. Consistent with Commission direction, this proposed rule

addresses four main topics: 1) amending 10 CFR parts 30, 40, and 70 to require

applicants to demonstrate (e.g., through installing safety and security equipment,

establishing facilities, or developing procedures) that they will use requested byproduct,

source, or special nuclear material for the purposes stated in their license applications;

2) amending 10 CFR parts 30, 40, and 70 to require that licensees transferring category

3 quantities of radioactive material verify that the recipient licensee is authorized to

possess and use the type, form, and quantity of the radioactive material being

transferred through the LVS or by contacting the license-issuing authority; 3) clarifying

verification procedures for transfers involving quantities of radioactive material that are

below category 2 thresholds by requiring that the oral certification license verification for

emergency shipments be confirmed by the use of one of the other acceptable

verification methods; requiring that the oral certification be confirmed by the end of the

next business day for category 3 quantities of radioactive material; and removing an

obsolete reporting service license verification method; and 4) revising 10 CFR part 32,

"Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing

Byproduct Material, to prohibit the distribution of devices containing category 3

radioactive material as generally licensed 7 devices.

This fourth change follows from Commission direction to conduct license

verification for transfers of category 3 quantities of materials. There are generally

7 The NRC regulation at 10 CFR 30.31(b) describes a general license as one that is provided by regulation, grants authority to a person for certain activities involving byproduct material and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. Conversely, 10 CFR 30.31(a) describes a specific license as one issued to a named person who has filed an application for the license under the provisions of this part and parts 32 through 36, and 39.

8 licensed devices8 that contain category 3 quantities of radioactive material under the

NRC and Agreement State jurisdiction. Bec ause a general licensee does not receive a

specific license from the NRC, there is no pr actical process for a transferor to perform a

license verification for transferring devices containing category 3 quantities of radioactive

material. Therefore, the NRC is proposing to license category 3 quantities of radioactive

material only under specific licenses in the future.

This proposed rulemaking would also address recommendations made by the

U.S. Government Accountability Office (GAO ). Past investigations have demonstrated

that a person posing as a legitimate applicant could set up a fictitious company or use

false information to fraudulently obtain an NRC license to possess and use radioactive

material. As described in GAO-16-330, Nuclear Security: NRC Has Enhanced the

Controls of Dangerous Radioactive Materials, but Vulnerabilities Remain, dated July

2016, GAO set up fictitious companies in several different states and, through these

companies, successfully obtained a license issued by an Agreement State to possess a

single source with a category 3 quantity of radioactive material. The GAO then altered

this license and used both the original license and the altered license to order two

sources, each with a category 3 quantity of radioactive material, from two different

vendors, thereby demonstrating that a potential bad actor could obtain more radioactive

material than authorized by the license. As described in GAO-22-103441, Preventing a

Dirty Bomb: Vulnerabilities Persist in NRCs Controls for Purchases of High-Risk

Radioactive Materials, dated July 2022, GAO also used fictitious companies to create

counterfeit licenses for possession and use of category 3 quantities of radioactive

8 Such devices are typically used to detect, measure, gauge, or control the thickness, density, level, or chemical composition of various items or to produce light or an ionized atmosphere. Examples of such devices are gas chromatographs (detector cells), density gauges, fill-level gauges, static elimination devices, and self-luminous exit signs containing tritium.

9 material from images found on the internet. The GAO successfully used a counterfeit

license to place orders at two different source vendors. This proposed rule would

address both the concern regarding the validity of license applicants and the need for

verification of licenses.

This proposed rule also would include conforming changes to recordkeeping

requirements in §§ 30.51(a) and 40.61(a) to require the documentation of a transferor

licensees verification that the recipient licensee is authorized to receive the subject

radioactive material being transferred. In affected sections, this proposed rule also

would include changes that are corrective or of a minor or nonpolicy nature and do not

substantially modify existing regulations in 10 CFR parts 30, 31, 32, 40, and 70 (e.g.,

inclusive language, plain language, conforming and clarifying language, and

reassignment and deletion of paragraphs).

III. Discussion

A. What action is the NRC taking?

The proposed actions address four main topics.

1) The NRC is proposing to amend 10 CFR parts 30, 40, and 70 to require that

applicants demonstrate that they will use the requested material for the purposes stated

in their license applications.

2) The NRC is proposing to amend 10 CFR parts 30, 40, and 70 to require that

licensees transferring category 3 quantities of radioactive material verify that the

recipient is authorized under its license to receive the type, form, and quantity of the

radioactive material to be transferred. Such verification would be made through the LVS

or by contacting the license-issuing authority for the recipient licensee.

10

3) The NRC is proposing to revise 10 CFR parts 30, 40, and 70 to require that,

for transfers involving category 3 quantities of radioactive material that are below

category 2 thresholds, the oral certification license verification for emergency shipments

must be confirmed either through the LVS or by contacting the license-issuing authority

by the end of the next business day following the receipt of oral certification. The intent

of this change is to provide additional security and accountability for category 3

quantities of radioactive material. This proposed rule also would remove the obsolete

verification method of obtaining sources of information compiled by a reporting service,

currently set forth in §§ 30.41(d)(4), 40.51(d)(4), and 70.42(d)(4).

4) The NRC is proposing to revise 10 CFR part 32 to require that devices

containing category 3 quantities of byproduct material can only be transferred to

licensees possessing a specific NRC or Ag reement State license. These licensees

would be required to follow the proposed license verification requirements in

§ 30.41(d)(1).

To support implementation of these provisions, the NRC is proposing to add a

definition of category 3 quantity of radioactive material to the Definitions sections of

10 CFR parts 30, 32, and 70 and a new appendix F to 10 CFR part 30 that would

provide thresholds for category 3 quantities of radioactive material. The materials and

thresholds for category 3 quantities of radioactive materials proposed to be included in

the new appendix F to 10 CFR part 30 are included in the following table. They refer to

the same 16 radioactive materials (14 single radionuclides and 2 combinations) that

make up category 1 and category 2 material, as defined in the NRCs regulations in 10

CFR part 37. They are also consistent with the IAEA Code of Conduct, which guides

domestic and international efforts for security of radioactive materials that are deemed to

be attractive targets for malevolent use.

11 Category 3 Threshold Radioactive Material TBq Ci

Americium-241 0.06 1.62

Americium-241/Be 0.06 1.62

Californium-252 0.02 0.54

Cobalt-60 0.03 0.81

Curium-244 0.05 1.435

Cesium-137 0.1 2.70

Gadolinium-153 1 27.0

Iridium-192 0.08 2.162

Plutonium-238 0.06 1.62

Plutonium-239/Be 0.06 1.62

Promethium-147 40 1,080

Radium-226 0.04 1.081

Selenium-75 0.20 5.40

Strontium-90 1 27.0

Thulium-170 20 540

Ytterbium-169 0.30 8.10

This proposed rule also would make conforming and clarifying changes to

various provisions in 10 CFR part 31, General Domestic Licenses for Byproduct

Materials, and in 10 CFR part 32 relating to the transfers of devices containing category

3 quantities of radioactive material that are currently regulated as generally licensed

devices. This proposed rule would include conforming changes to recordkeeping

requirements in §§ 30.51(a), 40.61(a), and proposed 70.42(d)(3) to require the

documentation of a transferor licensees verification that the recipient licensee is 12 authorized to receive the subject radioactive material being transferred. In affected

sections, this proposed rule also would include changes that are corrective or of a minor

or nonpolicy nature and do not substantially modify existing regulations in 10 CFR parts

30, 31, 32, 40, and 70 (e.g., inclusive language, plain language, conforming and

clarifying language, and reassignment and deletion of paragraphs).

B. Why do the requirements need to be revised?

I. Validity of License Applicants

The NRC is proposing to amend §§ 30.33(a)(3), 40.32(d), and 70.23(a)(5) to

state that specific licenses for byproduct material, source material, and special nuclear

material will only be issued if the applicant has demonstrated that it will use the

requested material for the purposes stated in its license application. This provision

would address the concern raised by the 2016 and 2022 GAO reports that a person

could obtain a valid license using a fictitious company or by providing false information.

The NRC and Agreement States use pre-licensing guidance to inform their

determination of whether the applicant will use the subject radioactive material as

specified in the application. The NRC updat ed this guidance in 2019 to address GAO

findings and it has been successfully used for numerous applications. The guidance is

not publicly available because the detailed considerations constitute security-related

information. To support understanding of this proposed requirement, the proposed

regulatory text includes three examples of the types of actions (installing safety and

security equipment, establishing facilities, or developing procedures) that the NRC can

consider in determining that the subject radioactive material will be used as specified in

the application and that the applicant can implement as a basis to support this

determination prior to the issuance of the license. The level of information needed by 13 the NRC, and the type of action on the part of the applicant that the NRC may require,

will depend on the proposed licensed activities and the type, quantity, and form of the

proposed radioactive material to be possessed and used under the license. For

example, certain persons can be readily determined to be valid applicants (i.e., persons

who will use the subject radioactive material for the purposes stated in the application).

In some instancesother cases, site visits to verify the appropriateness of the equipment,

facilities, procedures, and proposed activities may be necessary. In other cases, the

NRC may require the applicant to have appropr iate safety and security equipment in

place before it issues the license.

II. License Verification for Transfer of Category 3 Quantities of Radioactive

Material

The NRC is proposing to add new requirements to §§ 30.41(d)(1)(i), 40.51(d)(2),

and 70.42(d)(1)(i) that would require a licensee transferring category 3 quantities of

radioactive material to verify that the recipient licensee is authorized under its license to

receive the type, form, and quantity of the radioactive material to be transferred. Such

verification would be made through the LVS or the license-issuing authority for the

recipient licensee. The verification must occur before the transferor licensee can initiate

the transfer of radioactive material to the recipient licensee and further, the verification

must be conducted no earlier than 7 days prior to the transfer. The purpose of these

revisions is to enhance license verification methods for transfers involving category 3

quantities of radioactive material. The proposed requirements would address the

concern related to a person altering a valid license to obtain more or different radioactive

material than authorized or using a counterfeit license to obtain category 3 quantities of

radioactive materials. Requiring that the transferor licensee conduct the verification no 14 earlier than 7 days prior to the transfer would ensure that the verification is

contemporaneous with the transfer (i.e., that the verification will be of a license likely to

be in effect at the time of transfer and not one that has been suspended or revoked, or

otherwise modified by the license-issuing authority).

In addition to amending §§ 30.41(d)(1)(i), 40.51(d)(2), and 70.42(d)(1)(i), the

proposed rule would add a definition for category 3 quantity of radioactive material in

§§ 30.4, 32.2, and 70.4; and a new appendix, Appendix F to Part 30-Category 3

Radioactive Materials, that provides the thresholds for category 3 quantities of

radioactive materials.

III. Clarification of Verification Methods

The proposed amendments also would include new provisions in

§§ 30.41(d)(1)(ii), 30.41(d)(2)(iii), 40.51(d)(3), and 70.42(d)(1)(ii), and 70.42(d)(2)(iii) for

a more stringent follow-up verification method for licensees that process an emergency

shipment for transfers that are below category 2 quantities of radioactive material. This

proposed rule also would remove the obsolete verification method of obtaining sources

of information from a reporting service, currently set forth in §§ 30.41(d)(4), 40.51(d)(4),

and 70.42(d)(4).

IV. Prohibition of Transfers of Category 3 Generally Licensed Devices

The NRC is proposing to revise 10 CFR parts 31 and 32 to require that devices

containing category 3 quantities of radioactive material may only be distributed to

licensees that possess a specific NRC or Agreement State license; general licensees

would no longer be permitted to obtain devices that contain category 3 quantities of

radioactive material. With respect to 10 CFR part 31, the NRC would amend 15

§ 31.5(c)(8)(i) to require that a general licensee seeking to transfer a category 3 quantity

of radioactive material may only transfer such material to a specific licensee of the NRC

or an Agreement State. This transfer must follow the proposed license verification

requirements in § 30.41(d). The revised provision would remove the current ability to

transfer to another general licensee under the provisions of § 31.5(c)(9), because

license verification could not be conducted. With respect to 10 CFR part 32, the NRC

would similarly amend § 32.51 by adding a new paragraph (a)(3) that would exclude the

transfer of category 3 sources to general licensees.

These proposed changes would enhance control and license verification of

devices containing category 3 quantities of radioactive materials by requiring that the

transfers of all newly manufactured devices and those currently existing as of the

effective date of the rule be only to those licensees holding a specific NRC or Agreement

State license. The proposed revision would enhance consistency in the regulation of

devices containing category 3 quantities of radioactive materials in the National

Materials Program9 by requiring all transferees to haveusers to obtain a specific license

to use and possess devices containing category 3 quantities of radioactive materials.

Current general licensees with devices containing category 3 quantities of

radioactive material would continue to be authorized to possess and use these devices

under their general licenses after the effective date of the rule, as clarified in proposed

§ 31.5(f), Certain detecting, measuring, gauging, or controlling devices and certain

devices for producing light or an ionized atmosphere. Under the proposed rule, general

licensees would no longer be permitted to obtain devices that contain category 3

quantities of radioactive material. These existing devices are being excluded from the

9 The National Materials Program is the broad collective framework within which both the NRC and the Agreement States function in carrying out their respective regulatory programs for radioactive material.

16 proposed regulations because these devices have been in use under general licenses

and the NRC is aware of no security issues based on current operating experience. The

proposed rule would also require that future transfers or disposals of devices with

category 3 quantities of radioactive material, currently authorized under a general

license, be subject to license verification under the new provisions. In addition, general

licensees who are in possession of devices in the quantities listed in § 31.5(c)(13)(i)

must continue to complete an annual registration designed to verify that they are still in

possession of these devices.

C. Who would this action affect?

The regulatory changes proposed in this rule would affect all applicants applying

for a radioactive materials license (specifically, for the validity of license applicants

provisions) and all licensees who transfer category 3 quantities of radioactive material

(for the remaining provisions).

D. When would this action take effect?

The requirements proposed in this rule would take effect 30 days from the date of

publication of the final rule. Licensees would be required to comply with the

requirements within 30 days from the effective date of the final rule.

IV. Specific Requests for Comments

The NRC is seeking advice and reco mmendations from the public on the

proposed rule. We are particularly interested in comments and their supporting

rationales on the following:

17 The NRC is proposing a new requirement that a licensee transferring a

category 3 quantity of radioactive material verify, before transfer, that the recipient

licensee is authorized under the terms and conditi ons of its license to receive, possess,

and use the type, form, and quantity of the radioactive material being transferred, with

such verification to occur no earlier than 7 calendar days before the transfer. Is the

proposed timeframe of no earlier than 7 calendar days before transfer a suitable

requirement, given that the purpose of the change is to assure the validity of license

verifications? If not, how close to the date of transfer should a license be verified?

Provide a rationale for the response, including impacts on manufacturers or vendors that

conduct significant numbers of transfers of category 3 quantities of radioactive material

or Agreement States who process license veri fication requests from licensees that use

the NRC Form 749, Manual License Verification Report.

With respect to the proposed enhanced license verification requirement that a

licensee transferring a category 3 quantity of radioactive material must confirm with the

license-issuing authority or with the NRCs L VS that the recipient licensee has a valid

license to receive, possess, and use the type, form, and quantity of the radioactive

material being transferred, is there any subset of routine transactions involving transfers

of category 3 quantities of radioactive material between current licensees to which the

enhanced license verification requirement should not apply, or should apply but with

reduced frequency? Provide a rationale for the response.

The regulation in 10 CFR 37.11(c) provides an exemption for radioactive

waste and other materials with low specific activity. Is there a need for an exemption for

license verification requirements for transfers of category 3 quantities of radioactive

material dispersed in large amounts of low-level waste or other material?

18 What impact would there be on manufacturers, distributors, and future users

of generally licensed devices if devices containing category 3 quantities of radioactive

material were only authorized as specifically licensed devices after the effective date of

this rule? Provide a rationale for the response.

The NRC is seeking feedback on the proposed implementation timeline for

NRC licensees. Specifically, is 30 days after the effective date of the rule appropriate for

licensees to implement the proposed requirements or is additional time necessary?

Provide a rationale for your response, includi ng: 1) implementation concerns for either

license application or license verification requirements; 2) actions (e.g., equipment

procurement, infrastructure updates) that may not be achievable within the proposed 30-

day implementation period; and 3) appropr iate implementation timelines for each

requirement (if not 30 days).

The NRC is seeking feedback from Agreement States and other interested

parties on the proposed compatibility category for the proposed provisions in §§

30.33(a)(3), 40.32(d), and 70.23(a)(5), which would be designated as Compatibility

Category H&S.10 Specifically, is there a need for Agreement States to adopt essentially

identical requirements (i.e., Compatibility Category B) or, at least, should the Agreement

States adopt requirements that meet the essential objective of the proposed NRC

requirements (i.e., Compatibility Category C) to ensure a more uniform regulatory

approach across the National Materials Program of these provisions? Provide a

rationale for the response.

V. Section-by-Section Analysis

10 See 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).

19 The following paragraphs describe the specific changes proposed by this

rulemaking.

Section 30.4, Definitions

This proposed rule would add a definition for the term category 3 quantity of

radioactive material.

Section 30.33, General requirements for issuance of specific licenses

This proposed rule would redesignate paragraphs (a)(3) through (5) as

paragraphs (a)(4) through (6), respectively, and add a new paragraph (a)(3) to require all

applicants to demonstrate (e.g., through installing safety and security equipment,

establishing facilities, or developing procedures) that they will use the requested material

for the purposes stated in their license applications. This proposed rule also would

amend newly redesignated paragraph (a)(6) to make minor editorial changes for plain

language and to use inclusive language.

Section 30.41, Transfer of byproduct material

This proposed rule would revise paragraph (c) by adding a sentence that clarifies

that for transfers within the same organization, the licensee does not need to verify the

transfer. In addition, this paragraph would be revised to make minor editorial changes

for plain language.

This proposed rule would revise paragraph (d) for emergency shipments of

category 3 material to remove the 10-day confirmation requirement, add the requirement

to use the LVS or contact the license-issuing authority for confirmation by the end of the 20 next business day, and to make minor editorial changes for plain language and to use

inclusive language.

This proposed rule also would add a new paragraph (e) that would reference the

requirements in 10 CFR part 37 for the transfer of category 1 and category 2 quantities

of radioactive material.

Section 30.51, Records

This proposed rule would revise paragraph (a) to add the requirement for each

person who transfers byproduct material to keep records showing the verification of the

recipients license. In addition, this paragraph would be revised to make minor editorial

and conforming changes for plain language.

Appendix F to Part 30, Category 3 Radioactive Materials

This proposed rule would add a new appendix F to include a table of thresholds

for category 3 radioactive materials.

Section 31.5, Certain detecting, measuring, gauging, or controlling devices and

certain devices for producing light or an ionized atmosphere

This proposed rule would revise paragraphs (c)(7) and (8) by moving language

concerning the transfer and disposal of devices containing byproduct material through

export from paragraph (c)(8) to paragraph (c)(7). This change is intended to improve the

readability of both provisions such that the revised paragraph (c)(7) would concern

matters of exporting devices containing byproduct material, in accordance with 10 CFR

part 110, and the revised paragraph (c)(8) would concern domestic transfers of devices

containing byproduct material.

21 This proposed rule would further revise paragraph (c)(8)(i) to require that future

transfers or disposal of existing devices containing category 3 quantities of radioactive

material follow the transfer requirements in § 30.41(d). This proposed rule would revise

the introductory text of paragraph (c)(8)(ii) to extend the reporting requirement for

devices exported in accordance with paragraph (c)(7).

This proposed rule would revise the introductory text of paragraph (c)(9)(i) to

prohibit the transfer of existing devices containing category 3 quantities of radioactive

material to general licensees.

This proposed rule would remove footnote 2 and add its text as new paragraph

(e) and would add new paragraph (f) to clarify that existing general licensees with

devices containing category 3 quantities of radioactive material would continue to be

authorized toable to legally possess and use these devices under their general licenses

after the effective date of this rule.

In addition, this section would be revised to make minor editorial and conforming

changes for plain language.

Section 32.2, Definitions

This proposed rule would add a definition for category 3 quantity of radioactive

material.

Section 32.51, Byproduct material contained in devices for use under § 31.5;

requirements for license to manufacture, or initially transfer

This proposed rule would redesignate paragraphs (a)(3) through (6) as

paragraphs (a)(4) through (7), respectively, and add a new paragraph (a)(3) to prohibit

manufacturers or distributors from transferring any devices containing category 3 22 quantities of byproduct material to persons generally licensed under § 31.5. After the

effective date of the final rule, the transfer of devices containing category 3 quantities of

byproduct material would only be allowed to licensees who possess a specific license

issued by the NRC or an Agreement State and the transferor licensee would be required

to follow the license verification requirements in § 30.41(d)(1).

This proposed rule also would revise newly redesignated paragraph (a)(4)(iii) to

remove footnote 2. The text of footnote 2 would become new paragraph (a)(4)(iv).

In addition, this paragraph would be revised to make minor editorial and changes

for plain language.

Section 40.32, General requirements for issuance of specific licenses

This proposed rule would redesignate paragraphs (d) through (g) as paragraphs

(e) through (h), respectively, and add a new paragraph (d) to require applicants to

demonstrate (e.g., through installing safety and security equipment, establishing

facilities, or developing procedures) that they will use the requested material for the

purposes stated in their license applications. This proposed rule also would amend

newly redesignated paragraph (f) to make minor editorial changes for plain language

and to use inclusive language.

Section 40.51, Transfer of source or byproduct material

This proposed rule would revise paragraph (d) for emergency shipments of

category 3 quantities of radioactive material to remove the 10-day confirmation

requirement, add the requirement to use the LVS or contact the license-issuing authority

for confirmation by the end of the next business day for such emergency shipments, and

make a minor editorial change to use inclusive language.

23 Section 40.61, Records

This proposed rule would revise paragraph (a) to add the requirement for each

person who transfers byproduct material to keep records documenting the verification of

the recipients license. In addition, this paragraph would be revised to make minor

editorial changes for plain language.

Section 70.4, Definitions

This proposed rule would add a definition for category 3 quantity of radioactive

material.

Section 70.23, Requirements for the approval of applications

This proposed rule would redesignate paragraphs (a)(5) through (12) as

paragraphs (a)(6) through (13), respectively, and add a new paragraph (a)(5) to require

applicants to demonstrate (e.g., through installing safety and security equipment,

establishing facilities, or developing procedures) that they will use the requested material

for the purposes stated in their license applications. This proposed rule also would

amend paragraphs (a)(7) through (11) to make minor editorial changes for plain

language and to use inclusive language.

Section 70.42, Transfer of special nuclear material

This proposed rule would revise paragraph (c) by adding a sentence that clarifies

that for transfers within the same organization, the licensee does not need to verify the

transfer. In addition, this paragraph would be revised to make a minor editorial and plain

language change.

24 This proposed rule would revise paragraph (d) for emergency shipments of

category 3 quantities of radioactive material to remove the 10-day confirmation

requirement for such emergency shipments, add the requirement to use the LVS or

contact the license-issuing authority for confirmation by the end of the next business

day, and make a minor editorial change to use inclusive language. This proposed rule

also would consolidate the recordkeeping requirements for paragraph (d) in a new

paragraph (d)(3).

This proposed rule also would add a new paragraph (e) that would reference the

requirements in 10 CFR part 37 for the transfer of category 1 and category 2 quantities

of radioactive material.

VI. Regulatory Flexibility Certification

This proposed rule would affect 315 NRC licensees, 4,311 Agreement State

licensees, an estimated 10 new category 3 license applicants per year, and an estimated

129 applicants who would be applying for a materials license for the first time. This

includes a wide range of licensees in industry, medicine, and research. Typical uses of

category 3 quantities of radioactive material are in some fixed industrial gauges, such as

density gauges, thickness gauges, and fill-level gauges; some licensees performing

radiography operations; and licensees who conduct well logging using americium-

241/beryllium sources. In medical fields, high-dose-rate brachytherapy sources fall into

this category. In addition, category 3 quantities of radioactive material are used by

governmental agencies in security screening at ports and cargo terminals. ManyThe

majority of these licensees, excluding the governmental agencies engaged in security

screening at ports and cargo terminals, would be considered small entities as defined by

§ 2.810.

25 A recent review of the NRC database identified that approximately 26 percent of

the NRC materials licensees (707 of 2,741) qualify for reduced annual fees as small

entities under § 171.16, Annual fees: Materials licensees, holders of certificates of

compliance, holders of sealed source and device registrations, holders of quality

assurance program approvals, and government agencies licensed by the NRC.

Therefore, using this existing data, approximately 26 percent of the category 3 quantities

of radioactive material licensees that would be impacted by the rule are small entities.

The NRC has determined that this proposed rule, of the alternatives analyzed, is the

least costlyburdensome and most flexible alternative to accomplish the NRCs regulatory

objective of improving radioactive materialsource security and accountability. The draft

regulatory flexibility analysis is included with in the draft regulatory analysis, which is

available as indicated in the Availability of Documents section of this document.

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 the proposed regulation would affect them and

how the regulation may be tiered or otherwise modified to establishimpose less stringent

requirements on small entities while still adequately protecting the public health and

safety. Comments on how the regulation could be modified to take into account the

differing needs of small entities should specifically discuss:

a) The size of the business and ifhow the proposed regulation would result in a

significant economic costburden upon it as compared to a larger organization in the

same business community;

b) How the proposed regulation could be further modified to take into account the

businesss differing needs or capabilities;

26 c) The benefits that would accrue, or the detriments that would be avoided, if the

proposed regulation was modified as suggested by the commenter;

d) How the proposed regulation, as modified, would more closely equalize the

impact of the NRC regulations as opposed to providing special advantages to any

individuals or groups; and

e) How the proposed regulation, as modified, would still adequately protect the

public health and safety.

Comments should be submitted as indicated under the ADDRESSES caption of

this document.

VII. Regulatory Analysis

The NRC has prepared a draft regulatory analysis on this proposed rule. 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 ma y be submitted to the NRC as indicated

under the ADDRESSES caption of this document.

The NRCs analysis demonstrates that the proposed requirements, if issued by

final rule, would result in net (i.e., accounting for both costs and benefits) costs to

industry of approximately $12.4 million. Relative to the regulatory baseline, the net costs

to the Agreement States would be $7.59 million and to the NRC would be approximately

$3.12 million, with quantified costs due to rulemaking. The proposed rule would result in

net costs to industry, Agreement States, and the NRC of approximately $23.1 million

27 over a 15-year analysis horizon. Each of these totals represent the net present values

calculated using a 7-percent discount rate.

The NRC is proceeding with rulemaking based on qualitative factors because, if

implemented, the rulemaking would address the concern that a person could obtain a

valid license or radioactive materials by using a fictitious company or providing false

information, and it would prevent individuals without valid licenses from receiving

category 3 quantities of radioactive material.

VIII. Backfitting and Issue Finality

The NRC has determined that the backfitting provisions in §§ 50.109, 70.76, and

72.62, each entitled Backfitting, and the issue finality provisions in 10 CFR part 52,

Licenses, Certifications, and Approvals for Nuclear Power Plants, would not apply to

the changes proposed in 10 CFR parts 30, 31, 32, 40, and 70 of this proposed rule.

The primary class of licensees subject to this proposed rule, if ultimately issued,

would be those specific licensees authorized to possess category 3 quantities of

radioactive material who seek to transfer such material to another licensee. In addition,

the proposed recordkeeping changes and the removal of the verification method of

obtaining other sources of information compiled by a reporting service would apply to all

licensees seeking to transfer radioactive material to another licensee. These classes of

licensee would be regulated in accordance with 10 CFR parts 30, 31, 32, 40, and 70.

For those licensees subject to 10 CFR parts 30, 31, 32, and 40 that conduct activities

authorized under only those parts of the NRCs regulations, this proposed rule would not

be within the scope of the NRCs backfitting and issue finality provisions because 10

CFR parts 30, 31, 32, and 40 do not contain backfitting or issue finality provisions.

28 For licensees authorized to conduct activities under one or more of 10 CFR parts

30, 31, 32, and 40, as well as 10 CFR part 50, 52, or 72, this proposed rule would not be

within the scope of the NRCs backfitting and i ssue finality provisions. The rule would

affect the activities regulated under 10 CFR parts 30, 31, 32, and 40 and would not

affect activities that are an inextricable part of activities regulated under 10 CFR part 50,

52, or 72. Without an inextricable effect on activities regulated under 10 CFR part 50,

52, or 72, the proposed changes would not be subject to the backfitting or issue finality

provisions in those parts.

Although 10 CFR part 70 contains a backfitting provision, in § 70.76, which

applies to those 10 CFR part 70 licensees subject to subpart H of 10 CFR part 70, the

proposed rule would not constitute backfitting under § 70.76. The proposed changes

would not meet the definition of backfitting in § 70.76 because they would not be a

modification of, or addition to, systems, structures, or components of a facility, or to the

procedures or organization required to operate a facility. The proposed changes would

not require a 10 CFR part 70 licensee to transfer radioactive material to another

licensee. The proposed changes, if ultimately promulgated, would only become

applicable if a licensee voluntarily chooses to transfer such material.

Finally, the proposed rule also would require applicants for 10 CFR parts 30, 40,

and 70 licenses to demonstrate (e.g., through installing safety and security equipment,

establishing facilities, or developing procedures) that they will use the requested material

for the purposes stated in their license applications. For applicants under 10 CFR parts

30 and 40, these proposed changes would not be within the scope of the NRCs

backfitting and issue finality provisions. For applicants under 10 CFR part 70, these

changes would not constitute backfitting because the proposed changes concern

applicants, not current licensees. Applicants under 10 CFR part 70 would not already 29 have systems, structures, or components of a facility, or the procedures or organizations

required to operate a facility, that could be modified by the proposed rule, so the

proposed rule would not meet the definition of backfitting in § 70.76.

IX. Cumulative Effects of Regulation

The NRC seeks to minimize any potentia l negative consequences resulting from

the cumulative effects of regulation (CER). The CER refers to the challenges that

licensees or other impacted entities such as State partners may face while implementing

new regulatory positions, programs, or requirements (e.g., rules, generic letters, backfits,

inspections). The CER is an organizational effectiveness challenge that may result from

a licensee or impacted entity implementing a number of complex regulatory actions,

programs, or requirements with limited available resources.

The NRC is following its 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.

To better understand the potential CER implications incurred due to this

proposed rule, the NRC is requesting comment on the following questions. Responding

to these questions is voluntary, and the NRC will respond to any comments received in

the final rule.

1. In light of any current or projected CER challenges, does the NRCs proposed

effective date, 30 days from the date of publication of the final rule, provide sufficient

time to implement the new proposed require ments, including changes to programs,

procedures, and the facility? Please provide a rationale for your response.

30

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 suffi cient? Please provide a rationale for your

response.

3. Do other regulatory actions (of either the NRC or other agencies, e.g., orders,

generic communications, license amendment requests, or inspection findings of a

generic nature) influence the implementation of the proposed rules requirements?

Please provide a rationale for your response.

4. Are there unintended consequences? Does the proposed rule create

conditions that would be contrary to the proposed rules purpose and objectives? If so,

what are the unintended consequences, and how should they be addressed? Please

provide a rationale for your response.

5. Please comment on the NRCs cost and benefit estimates in the regulatory

analysis that supports the proposed rule.

X. 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.

XI. Draft Environmental Assessment and Draft Finding of No Significant 31 Environmental Impact

The NRC has determined that the proposed changes in §§ 30.4, 30.33(a)(4),

30.33(a)(5), 30.33(a)(6), 30.41(d)(2) introductory text, 30.41(d)(2)(i), 30.41(d)(2)(ii),

30.41(d)(2)(iv), 31.5, 31.5(c), 31.5(c)(1), 31.5(c)(2) introductory text, 31.5(c)(2)(i),

31.5(c)(2)(ii), 31.5(c)(3) introductory text, 31.5(c)(4) introductory text, 31.5(c)(4)(i),

31.5(c)(4)(ii), 31.5(c)(4)(iii), 31.5(c)(5), 31.5(c )(6), 31.5(c)(7), 31.5(c)(8)(ii), 31.5(c)(8)(iii),

31.5(c)(9), 31.5(c)(9)(i), 31.5(c)(10), 31.5(c)(11), 31.5(c)(12), 31.5(c)(13)(i),

31.5(c)(13)(ii), 31.5(c)(13)(iii) introductory text, 31.5(c)(14), 31.5(e), 31.5(f), 32.2,

32.51(a)(2)(iii), 32.51(a)(4), 32.51(a)(4)(iii), 32.51(a)(4)(iv), 32.51(a)(5), 32.51(a)(6),

32.51(a)(7), 40.32(a), 40.32(b), 40.32(e), 40.32(f), 40.32(g), 40.32(h), 40.51(d)(1),

40.51(d)(4), 70.4, 70.23(a)(1), 70.23(a)(6), 70.23(a)(7), 70.23(a)(8), 70.23(a)(9),

70.23(a)(10), 70.23(a)(11), 70.23(a)(12), 70.23(a)(13), 70.4(d)(2)(i), 70.42(d)(2)(ii), and

70.42(d)(2)(iv) of this rule are the types of actions that are corrective or of a minor or

nonpolicy nature and do not substantially modify existing regulations (i.e., inclusive

language, plain language, clarifying language, and the reassignment and deletion of

paragraphs) and, therefore, the NRC has determined that these changes meet the

criteria of the categorical exclusion listed in § 51.22(c)(2), and that no further analysis

under the National Environmental Policy Act of 1969 (NEPA), as amended, is required.

The NRC also has determined that the proposed changes in §§ 30.51(a)

introductory text, 30.51(a)(1), 30.51(a)(2), 30.51(a)(3), 40.61(a)(1), 40.61(a)(2),

40.61(a)(3), 40.61(a)(4), and 70.42(d)(3) of this rule are to recordkeeping requirements

(i.e., the documentation of a transferor licensees verification that the recipient licensee

is authorized, under the recipients license, to receive the type, form, and quantity of the

subject radioactive material being transferred) and, therefore, meet the criteria of the

32 categorical exclusion listed in § 51.22(c)(3)( ii) and that no further analysis under NEPA is

required.

A draft environmental assessment has been prepared for the proposed changes

that are not covered by the categorical exclusions listed in § 51.22(c)(2) and (3)(ii). This

draft environmental assessment has been made available to the public for comment

together with the proposed rule, as indicat ed under the Availability of Documents

section of this document. The Commissi on has preliminarily determined under NEPA

and the Commissions regulations in subpart A of 10 CFR part 51, that the proposed

amendments would not be a major Federal action significantly affecting the quality of the

human environment, and therefore, the pr eparation of an environmental impact

statement is not required. Specifically, t he NRC is proposing to amend its regulations in

10 CFR parts 30, 40, and 70 to require applicants to demonstrate (e.g., through installing

safety and security equipment, establishing facilities, or developing procedures) that they

will use the requested material for the purposes stated in their license applications. The

proposed changes would reduce the likelihood that an individual could obtain a valid

license by using a fictitious company or by providing false information (e.g., ensure the

legitimacy of applicants and their intent to use radioactive materials as stated on the

license application). Additionally, this rule making would require a more stringent follow-

up license verification method for licensees that process an emergency shipment for

transfers that are below category 2 quantities of radioactive material; for all shipments of

category 3 quantities, require the transferor licensees to seek verification through the

LVS or from the license-issuing authority that the recipient is authorized to receive the

type, form, and quantity of radioactive material to be transferred; and remove an

obsolete verification method. This rulemaking would also require that generally licensed

devices containing category 3 quantities of byproduct material can only be transferred to 33 licensees possessing a specific NRC or Ag reement State license. Finally, this

rulemaking would add a definition for category 3 quantity of radioactive material to the

Definitions sections of 10 CFR parts 30, 32, and 70, and make clarifying and other

minor, nonpolicy changes to various provisions in 10 CFR parts 31 and 32.

The preliminary determination of this environmental assessment is that there

would be no significant impact on the quality of the human environment from this action.

Public stakeholders should note, however, that comments on any aspect of this

environmental assessment may be submitted to the NRC as indicated under the

ADDRESSES caption of this document. After consideration of public comments on the

draft environmental assessment, the NRC will either finalize the environmental

assessment and issue a finding of no significant impact and thus complete its NEPA

process for this proposed rulemaking action, or the NRC will prepare a draft

environmental impact statement, which will be issued for public comment.

The NRC has sent a copy of the draft environmental assessment and this

proposed rule to every State Liaison Officer for their comment.

XII. Paperwork Reduction Act Statement

This proposed rule contains new or amended collections of information subject to

the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-21). This proposed rule has

been submitted to the Office of Management and Budget for review and approval of the

information collections.

Type of submission, new or revision: Revised.

34 The title of the information collection: Radioactive Source Security and

Accountability, Proposed Rule.

The form number if applicable: NRC Form 749, Manual License Verification

Report, and NRC Form 313, Application for Materials License.

How often the collection is required or requested: On occasion.

Who will be required or asked to respond: NRC and Agreement States licensees

who possess, use, and transfer of category 3 quantities of radioactive materials.

An estimate of the number of annual responses: 8,548 (8,415 responses for

NRC Form 749 and 133 responses for NRC Form 313).

The estimated number of annual respondents: 4,766 (4,633 respondents for

NRC Form 749 and 133 respondents for NRC Form 313).

An estimate of the total number of hours needed annually to comply with the

information collection requirement or request: 1,274 (702 hours0.00813 days <br />0.195 hours <br />0.00116 weeks <br />2.67111e-4 months <br /> for NRC Form 749 and

572 hours0.00662 days <br />0.159 hours <br />9.457672e-4 weeks <br />2.17646e-4 months <br /> for NRC Form 313).

Abstract: This proposed rule would result in changes in recordkeeping and

reporting burden relative to existing rules by requiring the increased use of NRC Form

313 and NRC Form 749 by licensees to comply with the proposed rule. The proposed

rule would require applicants to demonstrate (e.g., through installing safety and security 35 equipment, establishing facilities, or developing procedures) that they will use the

requested material for the purposes stated in their license applications. The proposed

provisions would help address the concern that a person could obtain a valid license or

radioactive materials by using a fictitious co mpany or providing false information. This

proposed rule also would require a licensee transferring category 3 quantities of

radioactive material to verify that the recipient (transferee) is licensed to receive the type,

form, and quantity of radioactive material to be transferred. The NRC is proposing a

more stringent follow-up license verification method for licensees that process an

emergency shipment for transfers that are below category 2 quantities of radioactive

material and to remove an obsolete verification method. Lastly, this proposed rule would

require devices containing category 3 radioactive material to only be distributed to

licensees that possess a specific NRC or Agreement State license.

The NRC is seeking public comment on the potential impact of the information

collections 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?

36 A copy of the OMB clearance package and proposed rule is available in ADAMS

under Accession No. ML22321A274 or can be obtained free of charge by contacting the

NRCs 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-2022-0103.

You may submit comments on any aspect of these proposed information

collections, 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-2022-0103.

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 (3150-0120 and 3150-0223), Attn: Desk Officer for

the Nuclear Regulatory Commission, 725 17 th Street, NW, Washington, DC 20503;

email: oira_submission@omb.eop.gov.

Submit comments by [INSERT DATE 30 DAYS AFTER DATE OF

PUBLICATION IN THE FEDERAL REGISTER]. Comments received after this date will

be considered if it is practical to do so, but the NRC staff is able to ensure consideration

only for comments received on or before this date.

Public Protection Notification

37 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.

XIII. 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, 31, 32,

40, and 70 under one or more of Sections 161b, 161i, or 161o of the AEA. Willful

violations of the rule would be subject to criminal enforcement. Criminal penalties as

they apply to regulations in 10 CFR parts 30, 31, 32, 40, and 70 are discussed in §§

30.64, 31.23, 32.303, 40.82, and 70.92, respectively.

XIV. Coordination with NRC Agreement States

The rulemaking working group that prepared this proposed rule included a

representative from the Organization of Agreement States. Comments from Agreement

States were taken into consideration during the development of this proposed rule.

XV. Coordination with the Advisory Committee on the Medical Uses of Isotopes

This proposed rule also would impact some medical licensees. The NRC

consulted with selected members of the Advisory Committee on the Medical Uses of

Isotopes (ACMUI) and provided an opportunity for those members to share their

38 individual views on the impacts of the proposed rule on the medical community. This

feedback was considered during the development of this proposed rule.

XVI. 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 (i ncluding regulations) required for

adequacy and having a particular health and safety component are those that are

designated as Categories A, B, C, D, NRC, and H&S; and those required for

compatibility include those regulations and other legally binding requirements designated

as Compatibility Categories A, B, C, and D. 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 bas is. The Agreement State program element

should be essentially identical to that of NRC. 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 39 program elements that do not meet any of the criteria of Category A, B, or C, above,

and, therefore, are not required 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, or provisions of title 10 of the Code of Federal

Regulations. These program elements should not be adopted by the Agreement States.

Category H&S program elements are not required for purposes of compatibility;

however, they have particular health and safety significance. The Agreement States

should adopt the essential objectives of such program elements to maintain an adequate

program.

Proposed new definition for category 3 quantity of radioactive material in

§§ 30.4, 32.2, and 70.4, and new appendix, Appendix F to Part 30-Category 3

Radioactive Materials would be designated as Compatibility Category B. The NRC has

determined that these definitions need to be adopted to ensure a consistent regulatory

approach across the National Materials Program and inconsistent definitions of this term

would have direct and significant transboundary implications.

Proposed new requirements related to validity of license applicants in §§

30.33(a)(3), 40.32(d), and 70.23(a)(5) would be designated as Compatibility Category

H&S because the essential objectives of these provisions have health and safety

significance and need to be adopted by the Agreement States.

Proposed new requirements for license verification in §§ 30.41(d)(1),

30.41(d)(1)(i), 30.41(d)(1)(ii), 30.41(d)(2), 30.41(e), 40.51(d)(2), 40.51(d)(3), 70.42(d)(1),

70.42(d)(1)(i), 70.42(d)(1)(ii), 70.42(d)(2), 70.42(d)(3), and 70.42(e) would be designated

as Compatibility Category C because the NRC has determined that the essential

objectives of these provisions need to be adopted by the Agreement States. Early 40 feedback from some Agreement States representatives indicated that no changes

regarding license verification should be proposed for § 40.51(d)(2) and (3), and the

related recordkeeping requirements in § 40.61(a), since there are no source materials

listed in the proposed Table 1 - Category 3 Thresholds in the new appendix F to 10

CFR part 30 that are subject to the proposed license verification requirements.

However, licensees who are the subject of 10 CFR part 40 also may possess category 3

quantities of radioactive material (e.g., specifically licensed devices). Accordingly, the

proposed regulatory change in § 40.51(d) is needed to provide a helpful pointer to the

license verification requirements in §30.41(d), with which these licensees must comply

when transferring category 3 quantities of radioactive material.

The NRC also notes that the proposed revisions to § 40.51(d)(2) and (3), and

§ 40.61(a), would be designated as Compatibility Category C because the NRC has

determined that the essential objectives of these provisions need to be adopted by the

Agreement States. The Agreement States can be more restrictive in their compatible

regulations. The proposed new requirement in § 31.5(f) for excluding existing devices

containing category 3 quantities of radioactive material from the proposed license

verification requirements would be designated as Compatibility Category C because the

NRC has determined that the essential objectives of these provisions need to be

adopted by the Agreement States. The proposed new requirements for prohibiting

licensees from manufacturing or initially transferring generally licensed devices with

category 3 quantities of radioactive materials in § 32.51(a)(3) would be designated as

Compatibility Category B. The NRC has determined that the program elements of this

provision need to be adopted to ensure a consistent regulatory approach across the

National Materials Program and inconsistent applications of these provisions would have

direct and significant transboundary implications.

41 Compatibility categories for other provisions that are subject to amendment or

reassignment would remain unchanged.

The final 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 10 CFR 30.4 New Definition: Category 3 quantity of - B radioactive material 10 CFR New General 30.33(a)(3) requirements for - H&S issuance of specific licenses 10 CFR Reassign General 30.33(a)(4) requirements for D D issuance of specific licenses 10 CFR Reassign General 30.33(a)(5) requirements for D D issuance of specific licenses 10 CFR Amend General 30.33(a)(6) requirements for D D issuance of specific licenses 10 CFR 30.41(c) Amend Transfer of byproduct material C C 10 CFR 30.41(d) Amend Transfer of byproduct material C C 10 CFR New Transfer of 30.41(d)(1) byproduct material - C 10 CFR New Transfer of 30.41(d)(1)(i) byproduct material - C 10 CFR New Transfer of 30.41(d)(1)(ii) byproduct material - C 10 CFR New Transfer of 30.41(d)(2) byproduct material - C

42 10 CFR Amend Transfer of 30.41(d)(2)(i) byproduct material C C 10 CFR Amend Transfer of 30.41(d)(2)(ii) byproduct material C C 10 CFR Amend Transfer of 30.41(d)(2)(iii) byproduct material C C 10 CFR Amend Transfer of 30.41(d)(2)(iv) byproduct material C C 10 CFR 30.41(e) New Transfer of byproduct material - C 10 CFR 30.51(a) Amend Records C C 10 CFR Amend Records C C 30.51(a)(1) 10 CFR Amend Records C C 30.51(a)(2) 10 CFR Amend Records C C 30.51(a)(3) 10 CFR Part 30, New Category 3 Appendix F Radioactive - B Materials 10 CFR 31.5 Amend Certain detecting, measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR 31.5(c) Amend Certain detecting, measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(1) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(2) measuring, gauging, C C or controlling devices and certain 43 devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(2)(i) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(2)(ii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(3) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(4) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(4)(i) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(4)(ii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(4)(iii) measuring, gauging, C C or controlling

44 devices and certain devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(5) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(6) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(7) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(8)(i) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(8)(ii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(8)(iii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(9) measuring, gauging, C C

45 or controlling devices and certain devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(9)(i) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(10) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(11) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(12) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(13)(i) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(13)(ii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere

46 10 CFR Amend Certain detecting, 31.5(c)(13)(iii) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(14) measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR 31.5(e) Amend Certain detecting, measuring, gauging, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR 31.5(f) New Certain detecting, measuring, gauging, or controlling devices and certain - C devices for producing light or an ionized atmosphere 10 CFR 32.2 New Definition: Category 3 quantity of - B radioactive material 10 CFR Amend Byproduct material 32.51(a)(2)(iii) contained in devices for use under § 31.5; requirements for license to B B manufacture, or initially transfer:

Conditions of licenses 10 CFR New Byproduct material 32.51(a)(3) contained in devices for use under § 31.5; requirements for - B license to manufacture, or initially transfer:

47 Conditions of licenses 10 CFR Reassign Byproduct material 32.51(a)(4) contained in devices for use under § 31.5; requirements for license to B B manufacture, or initially transfer:

Conditions of licenses 10 CFR Amend Byproduct material 32.51(a)(4)(iii) contained in devices for use under § 31.5; requirements for license to B B manufacture or initially transfer:

Conditions of licenses 10 CFR Reassign Byproduct material 32.51(a)(4)(iv) contained in devices for use under § 31.5; requirements for license to B B manufacture, or initially transfer:

Conditions of licenses 10 CFR Reassign Byproduct material 32.51(a)(5) contained in devices for use under § 31.5; requirements for license to B B manufacture, or initially transfer:

Conditions of licenses 10 CFR Amend Byproduct material 32.51(a)(6) contained in devices for use under § 31.5; B B requirements for license to manufacture, or

48 initially transfer:

Conditions of licenses 10 CFR Reassign Byproduct material 32.51(a)(7) contained in devices for use under § 31.5; requirements for license to B B manufacture, or initially transfer:

Conditions of licenses 10 CFR 40.32(a) Amend General requirements for H&S H&S issuance of specific licenses 10 CFR 40.32(b) Amend General requirements for H&S H&S issuance of specific licenses 10 CFR 40.32(d) New General requirements for - H&S issuance of specific licenses 10 CFR 40.32(e) Reassign General requirements for H&S H&S issuance of specific licenses 10 CFR 40.32(f) Amend General requirements for H&S H&S issuance of specific licenses 10 CFR 40.32(g) Reassign General requirements for H&S H&S issuance of specific licenses 10 CFR 40.32(h) Reassign General requirements for H&S H&S issuance of specific licenses 10 CFR Amend Transfer of source 40.51(d)(1) or byproduct C C material

49 10 CFR Amend Transfer of source 40.51(d)(2) or byproduct C C material 10 CFR Amend Transfer of source 40.51(d)(3) or byproduct C C material 10 CFR Amend Transfer of source 40.51(d)(4) or byproduct C C material 10 CFR 40.61(a) Amend Records C C 10 CFR Amend Records C C 40.61(a)(1) 10 CFR Amend Records C C 40.61(a)(2) 10 CFR Amend Records C C 40.61(a)(3) 10 CFR Amend Records C C 40.61(a)(4) 10 CFR 70.4 New Definition: Category 3 quantity of - B radioactive material 10 CFR Amend Requirements for 70.23(a)(1) the approval of D D applications 10 CFR New Requirements for 70.23(a)(5) the approval of - H&S applications 10 CFR Reassign Requirements for 70.23(a)(7) the approval of NRC NRC applications 10 CFR Amend Requirements for 70.23(a)(8) the approval of NRC NRC applications 10 CFR Amend Requirements for 70.23(a)(9) the approval of NRC NRC applications 10 CFR Amend Requirements for 70.23(a)(10) the approval of NRC NRC applications 10 CFR Amend Requirements for 70.23(a)(11) the approval of NRC NRC applications 10 CFR Reassign Requirements for 70.23(a)(12) the approval of NRC NRC applications

50 10 CFR Reassign Requirements for 70.23(a)(13) the approval of NRC NRC applications 10 CFR 70.42 (c) Amend Transfer of special nuclear material C C 10 CFR 70.42 (d) Amend Transfer of special nuclear material C C 10 CFR 70.42 New Transfer of special (d)(1) nuclear material - C 10 CFR 70.42 New Transfer of special (d)(1)(i) nuclear material - C 10 CFR 70.42 New Transfer of special (d)(1)(ii) nuclear material - C 10 CFR 70.42 New Transfer of special (d)(2) nuclear material - C 10 CFR 70.42 Amend Transfer of special (d)(2)(i) nuclear material C C 10 CFR 70.42 Amend Transfer of special (d)(2)(ii) nuclear material C C 10 CFR 70.42 Amend Transfer of special (d)(2)(iii) nuclear material C C 10 CFR 70.42 Amend Transfer of special (d)(2)(iv) nuclear material C C 10 CFR 70.42 New Transfer of special (d)(3) nuclear material - C 10 CFR 70.42 (e) New Transfer of special nuclear material - C

XVII. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-

113, requires that Federal agencies use technical standards that are developed or

adopted by voluntary consensus standards bodies unless the use of such a standard is

inconsistent with applicable law or otherwise impractical. In this proposed rule, the NRC

would revise the regulations associated with radioactive source security and

accountability. This action does not constitute the establishment of a standard that

contains generally applicable requirements.

51 XVIII. Availability of Guidance

The NRC expects to update NUREG-1556 series Consolidated Guidance About

Materials Licenses to make changes to conform with this rulemaking effort. To support

an accelerated development schedule for this proposed rule, the updates will be made in

a future revision of the guidance, rather than concurrently with this rulemaking. Interim

guidance, in the form of frequently asked questions (FAQs), will be added to the NRC's

public website. The draft FAQs are available in ADAMS under Accession No.

ML22334A029 and in the docket for the proposed rule (NRC-2022-0103). You may

submit comments on the draft FAQs by the methods outlined in the ADDRESSES

section of this document.

XIX. Public Meeting

The NRC will publish a notice of the location, time, and agenda of a public

meeting on the NRCs 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.

XX. 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.

52 DOCUMENT ADAMS ACCESSION NO. / WEB LINK SRM-COMJMB-16-0001, Staff ML16292A812 RequirementsCOMJMB-16-0001 Proposed Staff Re-Evaluation of Category 3 Source Accountability," dated October 18, 2016 SECY-17-0083, Re-evaluation of Category 3 ML17188A255 Source Security and Accountability in Response to SRM-COMJMB-16-0001, dated August 18, 2017 SRM-SECY-17-0083, Staff Requirements ML21355A290 SECY-17-0083Re-evaluation of Category 3 Source Security and Accountability in Response to SRM-COMJMB-16-0001, dated December 21, 2021 SECY-22-0065, Evaluation of the U.S. ML22103A249 Nuclear Regulatory Commissions General License Program for Devices Containing Radioactive Materials in Response to SRM-SECY-17-0083, dated July 8, 2022 GAO-16-330, Nuclear Security: NRC Has https://www.gao.gov/assets/gao Enhanced the Controls of Dangerous 330.pdf Radioactive Materials, but Vulnerabilities Remain, dated July 2016 GAO-22-103441, Preventing a Dirty Bomb: https://www.gao.gov/products/gao-Vulnerabilities Persist in NRCs Controls for 22-103441 Purchases of High-Risk Radioactive Materials, dated July 2022 Draft Regulatory Analysis ML22278A201 Draft Environmental Assessment ML22278A119 Draft FAQs ML22334A029209

The NRC may post materials related to this document, including public

comments, on the Federal rulemaking website at https://www.regulations.gov under

Docket ID NRC-2022-0103. 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-2022-0103); 2) click the

Subscribe link; and 3) enter an email addres s and click on the Subscribe link.

53 List of Subjects

10 CFR Part 30

Byproduct material, Criminal penalties, Government contracts, Intergovernmental

relations, Isotopes, Nuclear energy, Nuclear ma terials, Penalties, Radiation protection,

Reporting and recordkeeping requirements, Whistleblowing.

10 CFR Part 31

Byproduct material, Criminal penalties, Labeling, Nuclear energy, Nuclear

materials, Packaging and containers, Penalties, Radiation protection, Reporting and

recordkeeping requirements, Scientific equipment.

10 CFR Part 32

Byproduct material, Criminal penalties, Labeling, Nuclear energy, Nuclear

materials, Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 40

Criminal penalties, Exports, Government contracts, Hazardous materials

transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties,

Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.

10 CFR Part 70

Classified information, Criminal penalties, Emergency medical services,

Hazardous materials transportation, Material control and accounting, Nuclear energy,

Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting 54 and recordkeeping requirements, Scientific equipment, Security measures, Special

nuclear material, Whistleblowing.

For the reasons set out in the preamble and under the authority of the Atomic

Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended;

and 5 U.S.C. 552 and 553, the NRC is proposing to amend 10 CFR parts 30, 31, 32, 40,

and 70 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. In § 30.4, add the definition for category 3 quantity of radioactive material in

alphabetical order to read as follows:

§ 30.4 Definitions.

Category 3 quantity of radioactive material means a quantity of radioactive

material meeting or exceeding the category 3 threshold in table 1 of appendix F to this

part but less than the category 2 threshold in table 1 of appendix A to part 37 of this

chapter. This is determined by calculating the ratio of the total activity of each

55 radionuclide to the category 3 threshold for that radionuclide and adding the ratios

together. If the sum is equal to or exceeds 1, and is less than 10, the quantity would be

considered a category 3 quantity. Category 3 quantities of radioactive material do not

include the radioactive material contained in any fuel assembly, subassembly, fuel rod,

or fuel pellet.

3. In § 30.33:
a. Redesignate paragraphs (a)(3) through (5) as paragraphs (a)(4) through (6),

respectively;

b. Add a new paragraph (a)(3); and
c. Revise newly redesignated paragraph (a)(6).

The addition and revision read as follows:

§ 30.33 General requirements for issuance of specific licenses.

(a) * * *

(3) The applicant has demonstrated (e.g., through installing safety and security

equipment, establishing facilities, or developing procedures) that it will use the requested

byproduct material for the purposes stated in its application;

(6) In the case of an application for a license to receive and possess byproduct

material for the conduct of any activity that the NRC determines will significantly affect

the quality of the environment, the Director, Office of Nuclear Material Safety and

Safeguards, or the Directors designee, before commencement of construction of the

plant or facility in which the activity will be conducted, on the basis of information filed 56 and evaluations made under subpart A of part 51 of this chapter, has concluded, after

weighing the environmental, economic, technical, and other benefits against

environmental costs and considering available alternatives, that the action called for is

the issuance of the proposed license, with any appropriate conditions to protect

environmental values. Commencement of construction prior to such conclusion must be

grounds for denial of a license to receive and possess byproduct material in such plant

or facility. Commencement of construction as defined in § 30.4 may include non-

construction activities if the activity has a reasonable nexus to radiological safety and

security.

4. In § 30.41, revise paragraphs (c) and (d) and add a new paragraph (e) to read

as follows:

§ 30.41 Transfer of byproduct material.

(c) Before transferring byproduct material to a specific licensee of the

Commission or an Agreement State or to a general licensee who is required to register

with the Commission or with an Agreement State prior to receipt of the byproduct

material, the licensee transferring the material must verify that the transferee's license

authorizes the receipt of the type, form, and quantity of byproduct material to be

transferred. For transfers within the same organization, the licensee does not need to

verify the transfer.

57 (d) For transfers of byproduct material other than category 1 or 2 quantities of

radioactive material, as defined in § 37.5 of this chapter, the following methods for the

verification required by paragraph (c) of this section are acceptable:

(1) For transfers of category 3 quantities of radioactive material, as defined in §

30.4:

(i) The transferor must verify with the NRCs License Verification System or the

license-issuing authority, prior to conducting such transfer, that the transferee's license

authorizes the receipt of the type, form, and quantity of radioactive material to be

transferred. If the verification is conducted by contacting the license-issuing authority,

the transferor must document the verification. This verification must be conducted no

earlier than 7 days prior to the transfer.

(ii) In an emergency where the licensee cannot reach the license-issuing

authority and the license cannot be verified through the NRCs License Verification

System, the transferor may accept an oral certification by the transferee that the

transferee is authorized by license to receive the type, form, and quantity of radioactive

material to be transferred, specifying the license or registration certificate number,

issuing agency, and expiration date, provided that the oral certification is confirmed by

use of the NRCs License Verification Syst em or by contacting the license-issuing

authority by the end of the next business day.

(2) For all other transfers of radioactive material:

(i) The transferor may receive and review a current copy of the transferee's

specific license or registration certificate;

(ii) The transferor may receive and review a written certification prepared by the

transferee that the transferee is authorized by license or registration certificate to receive

58 the type, form, and quantity of byproduct material to be transferred, specifying the

license or registration certificate number, issuing agency, and expiration date;

(iii) For emergency shipments the transferor may accept an oral certification by

the transferee that the transferee is authorized by license or registration certificate to

receive the type, form, and quantity of byproduct material to be transferred, specifying

the license or registration certificate number, issuing agency and expiration date,

provided that the oral certification is confirmed in writing within 10 days by using the

methods in paragraph (d)(2)(i) of this section or paragraph (d)(2)(ii) of this section,

except for transfers subject to the requirements in paragraph (d)(1) of this section, where

the oral certification must be confirmed by the end of the next business day; or

(iv) When none of the methods of verification described in paragraphs (d)(2)(i)

through (iii) of this section are readily available or when a transferor desires to verify that

information received by one of such methods is correct or up-to-date, the transferor may

obtain and record confirmation from the Commission or the licensing agency of an

Agreement State that the transferee is licensed to receive the byproduct material.

(e) For transfers of category 1 and 2 quantities of radioactive material, as defined

in § 37.5 of this chapter, the requirements set forth in part 37 of this chapter apply.

5. In § 30.51, revise paragraph (a) to read as follows:

§ 30.51 Records.

(a) Each person who receives byproduct material pursuant to a license issued

under the regulations in this part and parts 31 through 36 of this chapter must keep

records showing the receipt, transfer, and disposal of the byproduct material, and each

59 person who transfers byproduct material must keep records showing the verification of

the transferees license, as follows:

(1) The transferee licensee must retain each record of receipt of byproduct

material as long as the material is possessed and for 3 years following transfer to

another licensee or disposal of the material.

(2) The licensee who transferred the material must retain each record of transfer,

including the record showing the verification of the transferees license, for 3 years after

each transfer unless a specific requirement in another part of the regulations in this

chapter dictates otherwise.

(3) The licensee who disposed of the material must retain each record of

disposal of byproduct material until the Commission terminates each license that

authorizes disposal of the material.

6. Add appendix F to part 30 to read as follows:

Appendix F to Part 30 - Category 3 Radioactive Materials

Table 1 - Category 3 Thresholds

The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The Ci values are provided for practical usefulness only.

60 Radioactive Category 3 Threshold Material TBq Ci

Americium-241 0.06 1.62

Americium-241

/Be 0.06 1.62

Californium-252 0.02 0.54

Cobalt-60 0.03 0.81

Curium-244 0.05 1.354

Cesium-137 0.1 2.70

Gadolinium-153 1 27.0

Iridium-192 0.08 2.162

Plutonium-238 0.06 1.62

Plutonium-239 0.06 1.62

/Be

Promethium-147 40 1,080

Radium-226 0.04 1.081

Selenium-75 0.20 5.40

Strontium-90 1 27.0

Thulium-170 20 540

Ytterbium-169 0.30 8.10

Note: Calculations Concerning Multiple Sources or Multiple Radionuclides

The "sum of fractions" methodology for evaluating combinations of multiple sources or multiple radionuclides is to be used in determining whether a quantity of radioactive material meets or exceeds the threshold, and is less than a Category 2 quantity of radioactive material, and is thus subject to the license verification requirements of this part.

61 I. If multiple sources of the same radionuclide and/or multiple radionuclides are included in the same transfer, the sum of the ratios of the total activity of each of the radionuclides must be determined to verify whether the activity in the transfer is less than the category 3 thresholds of table 1, as appropriate. If the calculated sum of the ratios, using the equation below, is greater than or equal to 1.0, and less than 10, then the applicable license verification requirements for category 3 quantities of radioactive material of this part apply.

II. First determine the total activity for each radionuclide from table 1. This is done by adding the activity of each individual source, material in any device, and any loose or bulk material that contains the radionuclide. Then use the equation below to calculate the sum of the ratios by inserting the total activity of the applicable radionuclides from table 1 in the numerator of the equation and the corresponding threshold activity from table 1 in the denominator of the equation.

Calculations must be performed in metric values (i.e., TBq) and the numerator and denominator values must be in the same units.

R1 = total activity for radionuclide 1 R2 = total activity for radionuclide 2 RN = total activity for radionuclide n AR1 = activity threshold for radionuclide 1 AR2 = activity threshold for radionuclide 2 ARN = activity threshold for radionuclide n 10 1.0

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

62

7. The authority citation for part 31 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 81, 161, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846); 44 U.S.C. 3504 note.

8. Amend § 31.5 by:
a. In paragraph (c) introductory text, removing the words pursuant to and

adding in their place the word under;

b. In paragraph (c)(1), removing the word Shall and adding in its place the word

Must, removing the word shall and adding in its place the word must, and removing

the word thereon and adding in its place the words on the device;

c. In paragraph (c)(2) introductory text, removing the word Shall and adding in

its place the word Must and removing the text six-month and adding in its place the

text 6-month;

d. In paragraph (c)(2)(i), removing the comma and adding in its place a

semicolon;

e. In paragraph (c)(2)(ii), removing the semicolon and adding in its place a

period;

f. In paragraph (c)(3) introductory text, removing the word Shall and adding in

its place the word Must;

g. In paragraph (c)(4) introductory text, removing the word Shall and adding in

its place the word Must, removing the text (c)(2) and (c)(3) and adding in its place the

text (c)(2) and (3), and removing the word shall and adding in its place the word

must;

h. In paragraph (c)(4)(i), removing the text three and adding in its place the text

3, and removing the period and adding in its place a semicolon;

63

i. In paragraph (c)(4)(ii), removing the text three and adding in its place the text

3, and removing the period and adding in its place the text ; and;

j. In paragraph (c)(4)(iii), removing the text three and adding in its place the text

3;

k. In paragraph (c)(5), removing the word Shall and adding in its place the word

Must, removing the text bequeral and adding in its place the word becquerel, and

removing the text GLTS and adding in its place the text Document Control

Desk/GLTS;

l. In paragraph (c)(6), removing the word Shall and adding in its place the word

Must;

m. Revising paragraphs (c)(7), (8)(i), and (8)(ii) introductory text;
n. In paragraphs (c)(8)(iii) introductory text and (c)(9) introductory text, removing

the word Shall and adding in its place the word Must;

o. Revising paragraph (c)(9)(i) introductory text;
p. In paragraph (c)(10), removing the word Shall from the beginning of the

paragraph and adding in its place the word Must, and removing the word shall from

the middle of the paragraph and adding in its place the word will;

q. In paragraphs (c)(11) through (13)(i), removing the word Shall and adding in

its place the word Must and removing the word shall and adding in its place the word

must;

r. In paragraph (c)(13)(ii), removing the word shall, wherever it appears, and

adding in its place the word must and removing the text Sec. and adding in its place

§;

s. In paragraph (c)(13)(iii) introductory text, removing the word shall and adding

in its place the word must; 64

t. In paragraph (c)(14), removing the word Shall and adding in its place the

word Must and removing the text GLTS and adding in its place the text Document

Control Desk/GLTS;

u. Adding paragraphs (e) and (f); and
v. Removing footnote 2.

The revisions and additions read as follows:

§ 31.5 Certain detecting, measuring, gauging, or controlling devices and certain

devices for producing light or an ionized atmosphere.

(c) * * *

(7) Must not export the device containing byproduct material, including for

purposes of transfer and disposal, except in accordance with part 110 of this chapter;

(8)(i) If transferring a device containing a category 3 quantity of radioactive

material, as defined in § 30.4 of this chapter, the transfer must be made to a specific

licensee of the NRC or Agreement States and follow the transfer requirements in

§ 30.41(d) of this chapter. For all other generally licensed devices, the transfer must be

made to either another general licensee as authorized in paragraph (c)(9) of this section,

or to a person authorized to receive the device by a specific license issued under parts

30 and 32 of this chapter, or part 30 of this chapter that authorizes waste collection, or

equivalent regulations of an Agreement State, or as otherwise approved under

paragraph (c)(8)(iii) of this section.

(ii) Must, within 30 days after the transfer of a device to a specific licensee or the

export of a device in accordance with paragraph (c)(7) of this section, furnish a report to

the Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document Control 65 Desk/GLTS, using an appropriate method listed in § 30.6(a) of this chapter. The report

must contain

(9) * * *

(i) The device remains in use at a particular location and does not contain a

category 3 quantity of radioactive material, as defined in § 30.4 of this chapter. In this

case, the transferor must give the transferee a copy of this section, a copy of §§ 31.2,

30.51, 20.2201, and 20.2202 of this chapter, and any safety documents identified in the

label of the device. Within 30 days of the transfer, the transferor must report to the

Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document Control

Desk/GLTS, using an appropriate method listed in § 30.6(a) of this chapter

(e) Persons possessing byproduct material in devices under a general license in

this section before January 15, 1975, may continue to possess, use, or transfer that

material in accordance with the labeling requirements of this section in effect on January

14, 1975.

(f) Persons possessing devices containing byproduct material greater than the

category 3 thresholds listed in table 1 of appendix F to part 30 of this chapter under a

general license in this section before [DATE 30 DAYS AFTER PUBLICATION OF

FINAL RULE], may continue to possess or use that material under a general license.

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER

CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

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

66 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.

10. In § 32.2, add a definition for category 3 quantity of radioactive material in

alphabetical order to read as follows:

§ 32.2 Definitions.

Category 3 quantity of radioactive material means a category 3 quantity of

radioactive material as defined in § 30.4 of this chapter.

11. In § 32.51:
a. In paragraph (a)(2)(iii), remove the word Column and add in its place the

word column;

b. Redesignate paragraphs (a)(3) through (6) as paragraphs (a)(4) through (7);
c. Add new paragraph (a)(3);
d. Revise newly redesignated paragraph (a)(4)(iii); and
e. Add paragraph (a)(4)(iv).

The additions and revision read as follows:

§ 32.51 Byproduct material contained in devices for use under § 31.5;

requirements for license to manufacture, or initially transfer.

(a) * *

  • 67 (3) The device contains less than the category 3 thresholds of the radionuclides

listed in table 1 of appendix F to part 30 of this chapter.

(4) * * *

(iii) The information called for in the following statement in the same or

substantially similar form:1

The receipt, possession, use, and transfer of this device Model ____, Serial No.___, are

subject to a general license or the equivalent and the regulations of the U.S. NRC or of a

State with which the NRC has entered into an agreement for the exercise of regulatory

authority. This label must be maintained on the device in a legible condition. Removal of

this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

(Name of manufacturer, or initial transferor)

(iv) The model, serial number, and the name of the manufacturer, or initial

transferor may be omitted from this label provided the information is elsewhere specified

in labeling affixed to the device.

1 Devices licensed under § 32.51 prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL

12. The authority citation for part 40 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69, 81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234, 274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114, 2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.

68

13. In § 40.32:
a. Remove the word and from the end of paragraphs (a) and (b);
b. Redesignate paragraphs (d) through (g) as paragraphs (e) through (h),

respectively;

c. Add new paragraph (d); and
d. Revise newly redesignated paragraph (f).

The addition and revision read as follows:

§ 40.32 General requirements for issuance of specific licenses.

(d) The applicant has demonstrated (e.g., through installing safety and security

equipment, establishing facilities, or developing procedures) that it will use the requested

source material for the purposes stated in its application;

(f) In the case of an application for a license for a uranium enrichment facility, or

for a license to possess and use source and byproduct material for uranium milling,

production of uranium hexafluoride, or for the conduct of any other activity which the

NRC determines will significantly affect the quality of the environment, the Director,

Office of Nuclear Material Safety and Safeguards, or the Directors designee, before

commencement of construction, on the basis of information filed and evaluations made

under subpart A of part 51 of this chapter, has concluded, after weighing the

environmental, economic, technical and other benefits against environmental costs and

considering available alternatives, that the action called for is the issuance of the

proposed license, with any appropriate conditions to protect environmental values.

Commencement of construction prior to this conclusion is grounds for denial of a license 69 to possess and use source and byproduct material in the plant or facility.

Commencement of construction as defined in § 40.4 may include non-construction

activities if the activity has a reasonable nexus to radiological safety and security.

14. In § 40.51, revise paragraph (d) to read as follows:

§ 40.51 Transfer of source or byproduct material.

(d) The following methods for the verification required by paragraph (c) of this

section are acceptable:

(1) The transferor may receive and review a current copy of the transferee's

specific license or registration certificate;

(2) The transferor may receive and review a written certification by the transferee

that the transferee is authorized by license or registration certificate to receive the type,

form, and quantity of source or byproduct material to be transferred, specifying the

license or registration certification number, issuing agency and expiration date. For

transfers that include or consist of a category 3 quantity of radioactive material, as

defined in § 30.4 of this chapter, the transferor must comply with the verification

requirements of § 30.41(d)(1) of this chapter;

(3) For emergency shipments, the transferor may accept an oral certification by

the transferee that the transferee is authorized by license or registration certificate to

receive the type, form, and quantity of source or byproduct material to be transferred,

specifying the license or registration certificate number, issuing agency and expiration

date, provided that the oral certification is confirmed in writing within 10 days by using

70 the methods in § 30.41(d)(2)(i) of this chapter or § 30.41(d)(2)(ii) of this chapter, except

for transfers subject to the requirements in § 30.41(d)(1) of this chapter, where the oral

certification must be confirmed by the end of the next business day; or

(4) When none of the methods of verification described in paragraphs (d)(1)

through (3) of this section are readily available or when a transferor desires to verify that

information received by one of such methods is correct or up-to-date, the transferor may

obtain and record confirmation from the Commission or the licensing agency of an

Agreement State that the transferee is licensed to receive the source or byproduct

material.

15. Amend § 40.61 by:
a. Revising paragraphs (a) introductory text and (a)(1);
b. In paragraphs (a)(2) and (3), removing the word shall and adding in its place

the word must; and

c. In paragraph (a)(4), removing the word Part and adding in its place the word

part.

The revisions read as follows:

§ 40.61 Records.

(a) Each person who receives source or byproduct material under a license

issued in accordance with the regulations in this part must keep records showing the

receipt, transfer, and disposal of this source or byproduct material, and each person who

transfers byproduct material must keep records showing the verification of the

transferees license, as follows:

(1) The transferee licensee must retain each record of receipt of source or 71 byproduct material as long as the material is possessed and for 3 years following

transfer to another licensee or disposition of the source or byproduct material.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

16. The authority citation for part 70 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 51, 53, 57(d), 108, 122, 161, 182, 183, 184, 186, 187, 193, 223, 234, 274, 1701 (42 U.S.C. 2071, 2073, 2077(d), 2138, 2152, 2201, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.

17. In § 70.4, add the definition for category 3 quantity of radioactive material in

alphabetical order to read as follows:

§ 70.4 Definitions.

Category 3 quantity of radioactive material means a category 3 quantity of

radioactive material as defined in § 30.4 of this chapter.

18. Amend § 70.23 by:
a. In paragraph (a)(1), removing the word section and adding in its place the

word Section;

72

b. Redesignating paragraphs (a)(5) through (12) as paragraphs (a)(6) through

(13), respectively;

c. Adding a new paragraph (a)(5);
d. Revising newly redesignated paragraphs (a)(7) and (8);
c. In newly redesignated paragraph (a)(9), removing the text pursuant to and

adding in its place the text under; and

d. In newly redesignated paragraph (a)(10), removing the text pursuant to and

adding in its place the text under and removing the text of this chapter,; and

e. In newly redesignated paragraph (a)(11), removing the text pursuant to and

adding in its place the text under.

The addition and revisions read as follows:

§ 70.23 Requirements for the approval of applications.

(a) * * *

(5) The applicant has demonstrated (e.g., through installing safety and security

equipment, establishing facilities, or developing procedures) that it will use the requested

special nuclear material for the purposes stated in its application;

(7) Where the applicant is required to submit a summary description of the

fundamental material controls provided in the applicants procedures for the control of

and accounting for special nuclear material under § 70.22(b), the applicant's proposed

controls are adequate;

(8) Where the proposed activity is processing and fuel fabrication, scrap

recovery, conversion of uranium hexafluoride, uranium enrichment facility construction

and operation, or any other activity which t he NRC determines will significantly affect the 73 quality of the environment, the Director of Nuclear Material Safety and Safeguards, or

the Directors designee, before commencement of construction of the plant or facility in

which the activity will be conducted, on the basis of information filed and evaluations

made under subpart A of part 51 of this chapter, has concluded, after weighing the

environmental, economic, technical, and other benefits against environmental costs and

considering available alternatives, that the action called for is the issuance of the

proposed license, with any appropriate conditions to protect environmental values.

Commencement of construction prior to this conclusion is grounds for denial to possess

and use special nuclear material in the plant or facility. Commencement of construction

as defined in § 70.4 may include non-constr uction activities if the activity has a

reasonable nexus to radiological safety and security.

19. In § 70.42, revise paragraphs (c) and (d) and add paragraph (e) to read as

follows:

§ 70.42 Transfer of special nuclear material.

(c) Before transferring special nuclear material to a specific licensee of the

Commission or an Agreement State or to a general licensee who is required to register

with the Commission or with an Agreement State prior to receipt of the special nuclear

material, the licensee transferring the material must verify that the transferee's license

authorizes receipt of the type, form, and quantity of special nuclear material to be

transferred. For transfers within the same organization, the licensee does not need to

verify the transfer.

74 (d) For transfers of special nuclear material other than category 1 or 2 quantities

of radioactive material, as defined in § 37.5 of this chapter, the following methods for the

verification required by paragraph (c) of this section are acceptable:

(1) For transfers of category 3 quantities of radioactive material, as defined in §

30.4 of this chapter:

(i) The transferor must verify with the NRCs License Verification System or the

license-issuing authority, prior to conducting such transfer, that the transferee's license

authorizes the receipt of the type, form, and quantity of radioactive material to be

transferred. If the verification is conducted by contacting the license-issuing authority,

the transferor must document the verification. This verification must be conducted no

earlier than 7 days prior to the transfer.

(ii) In an emergency where the licensee cannot reach the license-issuing

authority and the license cannot be verified through the NRCs License Verification

System, the transferor may accept an oral certification by the transferee that the

transferee is authorized by license to receive the type, form, and quantity of radioactive

material to be transferred, specifying the license or registration certificate number,

license number, current revision number, issuing agency, and expiration date, provided

that the oral certification is confirmed by use of the NRCs License Verification System or

by contacting the license-issuing authority by the end of the next business day.

(2) For all other transfers of radioactive material:

(i) The transferor may receive and review a current copy of the transferee's

specific license or registration certificate.

(ii) The transferor may receive and review a written certification by the transferee

that the transferee is authorized by license or registration certificate to receive the type,

75 form, and quantity of special nuclear material to be transferred, specifying the license or

registration certificate number, issuing agency, and expiration date.

(iii) For emergency shipments, the transferor may accept an oral certification by

the transferee that the transferee is authorized by license or registration certification to

receive the type, form, and quantity of special nuclear material to be transferred,

specifying the license or registration certificate number, issuing agency, and expiration

date, provided that the oral certification is confirmed in writing within 10 days by using

the methods in paragraph (d)(2)(i) of this section or paragraph (d)(2)(ii) of this section,

except for transfers subject to the requirements in paragraph (d)(1) of this section, where

the oral certification must be confirmed by the end of the next business day; or

(iv) When none of the methods of verification described in paragraphs (d)(2)(i)

through (iii) of this section are readily available or when a transferor desires to verify that

information received by one of these methods is correct or up-to-date, the transferor may

obtain and record confirmation from the Commission or the licensing agency of an

Agreement State that the transferee is licensed to receive the special nuclear material.

The transferor must retain the record of confirmation for 3 years from the date the record

is made.

(3) The transferor must keep a copy of the verification documentation as a record

for 3 years.

(e) For transfers of category 1 and 2 quantities of radioactive material, as defined

in § 37.5 of this chapter, the requirements set forth in part 37 of this chapter apply.

Dated: <Month XX, 20XX>.

For the Nuclear Regulatory Commission.

76 Brooke P. Clark, Secretary of the Commission.

77