SECY-22-0112, Enclosure 1 - Proposed Rule FRN for Radioactive Source Security and Accountability Rulemaking (Docket Id No. NRC-2022-0103, Rin No. 3120-AK83)

SECY-22-0112: Enclosure 1 - Proposed Rule FRN for Radioactive Source Security and Accountability Rulemaking (Docket Id No. NRC-2022-0103, Rin No. 3120-AK83)

ML22278A611
Person / Time
Issue date:	12/19/2022
From:	Office of Nuclear Material Safety and Safeguards
To:
References
NRC-2022-0103; RIN No. 3150-AK83
Download: ML22278A611 (76)

Text

[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 propo sed rule would require the

transferor licensee to conduct the verification through the NRC s 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 propo sed rule would require

that generally licensed devices containing category 3 quantitie s of byproduct material

can only be transferred to licens ees 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., inclus ive language, plain language, conforming and clarifying language, and reassignment and deletion of

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

as well as licensees who transfer category 3 quantities of radi oactive 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 o n a specific subject);

however, the NRC encourages electronic comment submission throu gh 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 docke ts to Dawn Forder;

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

contact the individuals listed in the FOR FURTHER INFORMATION C ONTACT section

of this document.

• Email comments to: Rulemaking.Comments@nrc.gov. If you do not

receive an automatic email reply confirming receipt, then conta ct 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 submittin g comments, see 2

Obtaining Information and Submitting Comments in the SUPPLEME NTARY

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 Safeguard s, 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 Sign ificant 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 Use s 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 pu blicly 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 ADA MS Public

Documents collection at https://www.nrc.gov/reading-rm/adams.ht ml. To begin the

search, select Begin Web-based ADAMS Search. For problems wi th ADAMS, please

contact the NRCs Public Document Room (PDR) reference staff at 1-800-397-4209, at

301-415-4737, or by email to PDR.Resource@nrc.gov. For the con venience of the

reader, instructions about obtaining materials referenced in th is 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 appointm ent 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 Fe deral

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

0103 in your comment submission.

The NRC cautions you not to include identifying or contact info rmation that you

do not want to be publicly disclosed in your comment submission. The NRC will post all

comment submissions at https://www.regulations.gov as well as e nter the comment

submissions into ADAMS. The NRC does not routinely edit commen t submissions to

remove identifying or contact information.

If you are requesting or aggregating comments from other person s 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 dis closed in their comment

submission. Your request should state that the NRC does not routinely edit comment

submissions to remove such information before making the commen t 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 that ensures the safety, security, and con trol 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 sources are subject to physical protection requirements appropr iate to the relative risk

they pose to safety and security. In addition, the NRC impleme nts 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 sources; the hi ghest 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 contac t with them, for some

hours. Category 3 sources are considered to be less dangerous than category 1 and

category 2 sources.

The NRC has developed a suite of information technology tools t hat it uses to

conduct materials licensing, overs ight, and radioactive source accountability. The key

systems used by the NRC and Agreem ent State materials programs are the National

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

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

to track category 1 and category 2 radioactive sources. Catego ry 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 posses s 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 credentiale d for system access to

verify certain information about licensees authorized to posses s, use, or transport

radioactive materials. The LVS allows licensees to confirm, pr ior 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, f orm, and quantity of

radioactive materials being requested.

In recent years, the NRC and Agreement States have considered w hether the

radioactive source security and accountability infrastructure c ould 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 Sou rce 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 ca tegory 3 sources to

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

Agreement States formed a joint working group and shared its re commendations with

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

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

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

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

Byproduct Material, 10 CFR part 40, Domestic Licensing of Sou rce 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 mater ials by using a fictitious

company or providing false information.

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

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

(ADAMS Accession No. ML21355A290), the Commission approved the NRC staffs

recommendations. Consistent with Commission direction, this pr oposed rule addresses

four main topics: 1) amending 10 CFR parts 30, 40, and 70 to r equire applicants to

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

facilities, or developing procedures) that they will use reques ted byproduct, source, or

special nuclear material for the purposes stated in their licen se 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 li censee 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-issuin g authority; 3) clarifying

verification procedures for transfers involving quantities of r adioactive material that are

below category 2 thresholds by requiring that the oral certific ation 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 mate rial; 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 co ntaining 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 material s. 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 und er the

NRC and Agreement State jurisdiction. Because a general licens ee does not receive a

specific license from the NRC, there is no practical process fo r a transferor to perform a

license verification for transferring devices containing catego ry 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 mad e by the

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

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

false information to fraudulently obtain an NRC license to poss ess and use radioactive

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

Controls of Dangerous Radioactive Materials, but Vulnerabilitie s Remain, dated July

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

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

single source with a category 3 quantity of radioactive materia l. 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 materia l, 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-2 2-103441, Preventing a

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

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

counterfeit licenses for possession and use of category 3 quant ities 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 successful ly 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 appl icants and the need for

verification of licenses.

This proposed rule also would include conforming changes to rec ordkeeping

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

licensees verification that the recipient licensee is authoriz ed 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 nonp olicy nature and do not

substantially modify existing regulations in 10 CFR parts 30, 3 1, 32, 40, and 70 (e.g.,

inclusive language, plain language, conforming and clarifying l anguage, 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 materia l 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 mat erial 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 woul d be made through the LVS

or by contacting the license-issuing authority for the recipien t licensee.

10

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

for transfers involving quantities of radioactive material that are below category 2

thresholds, the oral certification license verification for eme rgency shipments must be

confirmed either through the LVS or by contacting the license-i ssuing authority by the

end of the next business day following the receipt of oral cert ification. 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 report ing 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 tha t devices

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

licensees possessing a specific NRC or Agreement State license. These licensees

would be required to follow the proposed license verification r equirements in

§ 30.41(d)(1).

To support implementation of thes e 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 mat erial. The materials and

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

the new appendix F to 10 CFR part 30 are included in the follow ing 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 N RCs regulations in 10

CFR part 37. They are also consistent with the IAEA Code of Co nduct, 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 1.6

Americium-241/Be 0.06 1.6

Californium-252 0.02 0.5

Cobalt-60 0.03 0.8

Curium-244 0.05 1.4

Cesium-137 0.1 2.7

Gadolinium-153 1 27

Iridium-192 0.08 2.2

Plutonium-238 0.06 1.6

Plutonium-239/Be 0.06 1.6

Promethium-147 40 1,080

Radium-226 0.04 1.1

Selenium-75 0.20 5.4

Strontium-90 1 27

Thulium-170 20 540

Ytterbium-169 0.30 8.1

This proposed rule also would make conforming and clarifying ch anges to

various provisions in 10 CFR part 31, General Domestic License s 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 regulat ed as generally licensed

devices. This proposed rule would include conforming changes t o 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 tr ansferred. In affected

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

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

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

clarifying language, and reassignment and deletion of paragraph s).

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 mat erial, 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 appli cation. This provision

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

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

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

determination of whether the applicant will use the subject rad ioactive material as

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

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

not publicly available because the detailed considerations cons titute security-related

information. To support understanding of this proposed require ment, the proposed

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

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

consider in determining that the subject radioactive material w ill 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 th at the NRC may require,

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

proposed radioactive material to be possessed and used under th e 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 other cases, site visits to verify the appropriateness of th e equipment, facilities,

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

require the applicant to have appropriate safety and security e quipment 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 c ategory 3 quantities of

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

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

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

recipient licensee. The verification must occur before the tra nsferor 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 transf ers 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 obta in 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 o f radioactive material in

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

Radioactive Materials, that provides the thresholds for catego ry 3 quantities of

radioactive materials.

III. Clarification of Verification Methods

The proposed amendments also would include new provisions in

§§ 30.41(d)(1)(ii), 40.51(d)(3), and 70.42(d)(1)(ii) for a more stringent follow-up

verification method for licensees that process an emergency shi pment 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 D evices

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

containing category 3 quantities of radioactive material may on ly be distributed to

licensees that possess a specific NRC or Agreement State licens e; general licensees

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

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

§ 31.5(c)(8)(i) to require that a general licensee seeking to t ransfer a category 3 quantity 15 of radioactive material may only transfer such material to a sp ecific 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 1 0 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 verifi cation of

devices containing category 3 quantities of radioactive materia ls 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 materia ls in the National

Materials Program9 by requiring all users to obtain a specific license to use and possess

devices containing category 3 quantities of radioactive materia ls.

Current general licensees with devices containing category 3 qu antities of

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

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

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

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

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

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

proposed regulations because these devices have been in use und er general licenses

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

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

category 3 quantities of radioactive material, currently author ized under a general

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

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

must continue to complete an annual registration designed to ve rify 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 a pplicants applying

for a radioactive materials license (specifically, for the vali dity of license applicants

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

(for the remaining provisions).

D. When would this action take effect?

The requirements proposed in this rule would take effect 30 day s 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 fina l rule.

IV. Specific Requests for Comments

The NRC is seeking advice and recommendations 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 transfe rring a

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

licensee is authorized under the terms and conditions of its li cense to receive, possess,

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

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

proposed timeframe of no earlier than 7 calendar days before tr ansfer 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 shoul d a license be verified?

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

conduct significant numbers of transfers of category 3 quantiti es of radioactive material

or Agreement States who process license verification requests f rom licensees that use

the NRC Form 749, Manual License Verification Report.

• With respect to the proposed enhanced license verification req uirement that a

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

license-issuing authority or with the NRCs LVS that the recipi ent licensee has a valid

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

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

of category 3 quantities of radioactive material between curren t licensees to which the

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

reduced frequency? Provide a rationale for the response.

• 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.

18

• The NRC is seeking feedback on the proposed implementation tim eline for

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

licensees to implement the proposed requirements or is addition al time necessary?

Provide a rationale for your response, including: 1) implementa tion concerns for either

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

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

day implementation period; and 3) appropriate implementation ti melines for each

requirement (if not 30 days).

• The NRC is seeking feedback from Agreement States and other in terested

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 designat ed as Compatibility

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

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 provisi ons? Provide a

rationale for the response.

V. Section-by-Section Analysis

The following paragraphs describe the specific changes proposed by this

rulemaking.

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 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 li censes

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

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

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

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

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

amend newly redesignated paragraph (a)(6) to make minor editori al 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 sent ence that clarifies

that for transfers within the same organization, the licensee d oes 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 sh ipments of

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

to use the LVS or contact the license-issuing authority for con firmation by the end of the

next business day, and to make minor editorial changes for plai n language and to use

inclusive language.

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

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

of radioactive material.

Section 30.51, Records

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

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

recipients license. In addition, this paragraph would be revi sed 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 tab le of thresholds

for category 3 radioactive materials.

Section 31.5, Certain detecting, measuring, gauging, or control ling devices and

certain devices for producing light or an ionized atmosphere

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

concerning the transfer and disposal of devices containing bypr oduct 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 domest ic transfers of devices

containing byproduct material.

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 21 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 rep orting requirement for

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

This proposed rule would revise the introductory text of parag raph (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 ge neral licensees with

devices containing category 3 quantities of radioactive materia l would continue to be

able to legally possess and use these devices under their gener al licenses after the

effective date of this rule.

In addition, this section would be revised to make minor edito rial 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 para graph (a)(3) to prohibit

manufacturers or distributors from transferring any devices con taining category 3

quantities of byproduct material to persons generally licensed under § 31.5. After the

effective date of the final rule, the transfer of devices conta ining category 3 quantities of 22 byproduct material would only be allowed to licensees who posse ss a specific license

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

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

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

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

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

for plain language.

Section 40.32, General requirements for issuance of specific li censes

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

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

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

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

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

newly redesignated paragraph (f) to make minor editorial change s 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 sh ipments 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 e mergency shipments, and

make a minor editorial change to use inclusive language.

Section 40.61, Records 23 This proposed rule would revise paragraph (a) to add the requi rement for each

person who transfers byproduct material to keep records documen ting 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 par agraph (a)(5) to require

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

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

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

amend paragraphs (a)(7) through (11) to make minor editorial ch anges 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 sent ence that clarifies

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

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

language change.

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

category 3 quantities of radioactive material to remove the 10- day confirmation 24 requirement for such emergency shipments, add the requirement t o use the LVS or

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

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

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

paragraph (d)(3).

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

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

of radioactive material.

VI. Regulatory Flexibility Certification

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

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

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

includes a wide range of licensees in industry, medicine, and r esearch. 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 l icensees performing

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

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

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

governmental agencies in security screening at ports and cargo terminals. The majority

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

at ports and cargo terminals, would be considered small entitie s as defined by § 2.810.

A recent review of the NRC database identified that approximate ly 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, hol ders of certificates of 25 compliance, holders of sealed source and device registrations, holders of quality

assurance program approvals, and government agencies licensed b y the NRC.

Therefore, using this existing data, approximately 26 percent o f 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 alternat ives analyzed, is the

least burdensome and most flexible alternative to accomplish th e NRCs regulatory

objective of improving radioactive source security and accounta bility. The draft

regulatory flexibility analysis is included within the draft re gulatory analysis, which is

available as indicated in the Availability of Documents secti on of this document.

The NRC is seeking public comment on the potential impact of th is proposed rule

on small entities. The NRC particularly desires comment from l icensees who qualify as

small businesses, specifically as to how the proposed regulatio n would affect them and

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

requirements on small entities while still adequately protectin g the public health and

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

differing needs of small entities should specifically discuss:

a) The size of the business and how the proposed regulation wou ld result in a

significant economic burden upon it as compared to a larger org anization in the same

business community;

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

businesss differing needs or capabilities;

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

proposed regulation was modified as suggested by the commenter;

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

impact of the NRC regulations as opposed to providing special a dvantages to any

individuals or groups; and

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

public health and safety.

Comments should be submitted as indicated under the ADDRESSES c aption of

this document.

VII. Regulatory Analysis

The NRC has prepared a draft regulatory analysis on this propo sed rule. The

analysis examines the costs and benefits of the alternatives co nsidered by the NRC.

The NRC requests public comment on the draft regulatory analysi s. The regulatory

analysis is available as indicated in the Availability of Docu ments section of this

document. Comments on the draft analysis may be submitted to t he 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 cost s and benefits) costs to

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

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

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

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

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

calculated using a 7-percent discount rate.

27 The NRC is proceeding with rulemaking based on qualitative fact ors because, if

implemented, the rulemaking would address the concern that a pe rson could obtain a

valid license or radioactive materials by using a fictitious co mpany or providing false

information, and it would prevent individuals without valid lic enses 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 prov isions in 10 CFR part 52,

Licenses, Certifications, and Approvals for Nuclear Power Plan ts, 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, i f ultimately issued,

would be those specific licensees authorized to possess categor y 3 quantities of

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

the proposed recordkeeping changes and the removal of the verif ication method of

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

licensees seeking to transfer radioactive material to another l icensee. 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 issu e finality provisions.

For licensees authorized to conduct activities under one or mor e 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 28 within the scope of the NRCs backfitting and issue finality pr ovisions. 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 r egulated under 10 CFR part 50,

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

52, or 72, the proposed changes would not be subject to the bac kfitting 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 becau se they would not be a

modification of, or addition to, systems, structures, or compon ents 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 m aterial to another

licensee. The proposed changes, if ultimately promulgated, wou ld only become

applicable if a licensee voluntarily chooses to transfer such m aterial.

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 wi ll use the requested material

for the purposes stated in their license applications. For app licants 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 unde r 10 CFR part 70, these

changes would not constitute backfitting because the proposed c hanges concern

applicants, not current licensees. Applicants under 10 CFR par t 70 would not already

have systems, structures, or components of a facility, or the p rocedures or organizations

29 required to operate a facility, that could be modified by the p roposed 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 potential negative consequences r esulting 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., rule s, generic letters, backfits,

inspections). The CER is an organizational effectiveness chall enge 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 du e to this

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

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

the final rule.

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

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

time to implement the new proposed requirements, including chan ges to programs,

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

2. If CER challenges currently exist or are expected, what sho uld be done to

address them? For example, if more time is required for impleme ntation of the new 30 requirements, what period of time is sufficient? Please provid e a rationale for your

response.

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

generic communications, license amendment requests, or inspecti on findings of a

generic nature) influence the implementation of the proposed ru les 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 purpos e and objectives? If so,

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

provide a rationale for your response.

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

analysis that supports the proposed rule.

X. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federa l 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 we ll as the Presidential

Memorandum, Plain Language in Government Writing, published J une 10, 1998 (63

FR 31885). The NRC requests comment on this document with resp ect to the clarity

and effectiveness of the language used.

XI. Draft Environmental Assessment and Draft Finding of No Sig nificant

Environmental Impact

31 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) introduc tory text, 31.5(c)(2)(i),

31.5(c)(2)(ii), 31.5(c)(3) introductory text, 31.5(c)(4) introd uctory 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 regul ations (i.e., inclusive

language, plain language, clarifying language, and the reassign ment and deletion of

paragraphs) and, therefore, the NRC has determined that these c hanges 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 r ecordkeeping requirements

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

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

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

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

required.

32 A draft environmental assessment has been prepared for the prop osed 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 p ublic for comment

together with the proposed rule, as indicated under the Availa bility of Documents

section of this document. The Commission has preliminarily det ermined 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 af fecting the quality of the

human environment, and therefore, the preparation of an environmental impact

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

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

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

will use the requested material for the purposes stated in thei r 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 inf ormation (e.g., ensure the

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

license application). Additionally, this rulemaking would requ ire a more stringent follow-

up license verification method for licensees that process an em ergency shipment for

transfers that are below category 2 quantities of radioactive m aterial; 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 transfer red; and remove an

obsolete verification method. This rulemaking would also requi re 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, this

rulemaking would add a definition for category 3 quantity of r adioactive material to the 33 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 envi ronment from this action.

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

environmental assessment may be submitted to the NRC as indicat ed under the

ADDRESSES caption of this document. After consideration of pub lic comments on the

draft environmental assessment, the NRC will either finalize th e environmental

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

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

environmental impact statemen t, 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 infor mation 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 revie w and approval of the

information collections.

Type of submission, new or revision: Revised.

The title of the information collection: Radioactive Source Security and

Accountability, Proposed Rule.

34 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 radi oactive 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 in creased use of NRC Form

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

rule would require applicants to demonstrate (e.g., through ins talling safety and security

equipment, establishing facilities, or developing procedures) t hat they will use the

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

provisions would help address the concern that a person could o btain a valid license or 35 radioactive materials by using a fictitious company or providin g false information. This

proposed rule also would require a licensee transferring catego ry 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 licens ees that process an

emergency shipment for transfers that are below category 2 quan tities of radioactive

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

require devices containing category 3 radioactive material to o nly be distributed to

licensees that possess a specific NRC or Agreement State licens e.

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

collections contained in this proposed rule and on the followin g issues:

1. Is the proposed information collection necessary for the pro per

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 co llection

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 collec tion techniques or other

forms of information technology?

A copy of the OMB clearance package and proposed rule is availa ble in ADAMS

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

NRCs Public Document Room reference staff at 1-800-397-4209, a t 301-415-4737, or

by email to PDR.Resource@nrc.gov. You may obtain information a nd comment 36 submissions related to the OMB clearance package by searching o n

https://www.regulations.gov under Docket ID NRC-2022-0103.

You may submit comments on any aspect of these proposed informa tion

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), A ttn: 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

The NRC may not conduct or sponsor, and a person is not require d to respond to,

a collection of information unless the document requesting or r equiring the collection

displays a currently valid OMB control number.

XIII. Criminal Penalties 37 For the purposes of Section 223 of the Atomic Energy Act of 19 54, as amended

(AEA), the NRC is issuing this proposed rule that would amend 1 0 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 7 0 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 i ncluded a

representative from the Organization of Agreement States. Comm ents from Agreement

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

XV. Coordination with the Advisory Committee on the Medical Us es of Isotopes

This proposed rule also would im pact some medical licensees. T he NRC

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

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

individual views on the impacts of the proposed rule on the med ical community. This

feedback was considered during the development of this proposed rule.

XVI. Compatibility of Agreement State Regulations

38 Under the Agreement State Program Policy Statement approved b y the

Commission on October 2, 2017, and published in the Federal Register on October 18,

2017 (82 FR 48535), NRC program elements (including regulations ) required for

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

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

compatibility include those regulations and other legally bindi ng requirements designated

as Compatibility Categories A, B, C, and D. Compatibility Cate gory A are those program

elements that include basic radiation protection standards and scientific terms and

definitions that are necessary to understand radiation protecti on concepts. An

Agreement State should adopt Category A program elements in an essentially identical

manner in order to provide uniformity in the regulation of agre ement material on a

nationwide basis. Compatibility Category B pertains to a limite d number of program

elements that cross jurisdictional boundaries and should be add ressed to ensure

uniformity of regulation on a nationwide basis. 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 co nflict, duplication, gaps,

or other conditions that would jeopardize an orderly pattern in the regulation of

agreement material on a national basis. An Agreement State sho uld adopt the essential

objectives of the Category C program elements. Compatibility C ategory D are those

program elements that do not meet any of the criteria of Catego ry A, B, or C, above,

and, therefore, are not required to be adopted by Agreement Sta tes for purposes of

compatibility. Compatibility Category NRC are those program el ements that address

areas of regulation that cannot be relinquished to the Agreemen t States under the

Atomic Energy Act of 1954, as amended, or provisions of title 1 0 of the Code of Federal 39 Regulations. These program elements should not be adopted by the Agreemen t 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 Cat egory 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 applic ants in §§

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

H&S because the essential objectives of these provisions have h ealth 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 Agreem ent States. Early

feedback from some Agreement States representatives indicated t hat 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 a re 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 verificati on requirements.

40 However, licensees who are the subject of 10 CFR part 40 also m ay 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 thes e 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 bec ause the NRC has

determined that the essential objectives of these provisions ne ed 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 exc luding existing devices

containing category 3 quantities of radioactive material from t he proposed license

verification requirements would be designated as Compatibility Category C because the

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

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

licensees from manufacturing or initially transferring generall y 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 prog ram elements of this

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

National Materials Program and inconsistent applications of the se provisions would have

direct and significant transboundary implications.

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 N RC and the

Agreement States, thereby providing consistency among Agreement State and NRC

requirements. The compatibility categories are designated in t he following table:

41 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 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

42 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, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(2)(i) measuring, gauging, or controlling C C devices and certain devices for

43 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, or controlling devices and certain C C devices for producing light or an ionized atmosphere 10 CFR Amend Certain detecting, 31.5(c)(5) measuring, gauging, C C or controlling devices and certain

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

45 devices and certain 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 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, C C

46 or controlling devices and certain 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 license to - B manufacture, or initially transfer:

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

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

48 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 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

49 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 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 50 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, P ub. L. 104-

113, requires that Federal agencies use technical standards tha t 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 establishm ent of a standard that

contains generally applicable requirements.

XVIII. Availability of Guidance

The NRC expects to update NUREG-1556 series Consolidated Guida nce About

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

an accelerated development schedule for this proposed rule, the updates will be made in 51 a future revision of the guidance, rather than concurrently wit h this rulemaking. Interim

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

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

ML22334A029 and in the docket for the proposed rule (NRC-2022-0 103). You may

submit comments on the draft FAQs by the methods outlined in th e 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 NRCs public meeting website for information

about the public meeting at: https://www.nrc.gov/public-involv e/public-

meetings/index.cfm.

XX. Availability of Documents

The documents identified in the following table are available t o interested

persons through one or more of the following methods, as indica ted.

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

52 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 ML22334A209

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

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

Docket ID NRC-2022-0103. In addition, the Federal rulemaking w ebsite allows

members of the public to receive alerts when changes or additio ns occur in a docket

folder. To subscribe: 1) navigate to the docket folder (NRC-2 022-0103); 2) click the

Subscribe link; and 3) enter an email address and click on th e Subscribe link.

List of Subjects

10 CFR Part 30

53 Byproduct material, Criminal penalties, Government contracts, I ntergovernmental

relations, Isotopes, Nuclear ener gy, Nuclear materials, Penalties, Radiation protection,

Reporting and recordkeeping requirements, Whistleblowing.

10 CFR Part 31

Byproduct material, Criminal penalties, Labeling, Nuclear ener gy, Nuclear

materials, Packaging and containers, Penalties, Radiation prote ction, Reporting and

recordkeeping requirements, Scientific equipment.

10 CFR Part 32

Byproduct material, Criminal penalties, Labeling, Nuclear ener gy, Nuclear

materials, Radiation protection, Reporting and recordkeeping re quirements.

10 CFR Part 40

Criminal penalties, Exports, Government contracts, Hazardous ma terials

transportation, Hazardous waste, Nuclear energy, Nuclear materi als, Penalties,

Reporting and recordkeeping requirements, Source material, Uran ium, Whistleblowing.

10 CFR Part 70

Classified information, Criminal penalties, Emergency medical s ervices,

Hazardous materials transportation, Material control and accoun ting, Nuclear energy,

Nuclear materials, Packaging and containers, Penalties, Radiati on protection, Reporting

and recordkeeping requirements, Scientific equipment, Security measures, Special

nuclear material, Whistleblowing.

54 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 o f 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 foll ows:

Authority: Atomic Energy Act of 1954, secs. 11, 81, 161, 181, 182, 183, 18 4, 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, sec s. 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 appen dix A to part 37 of this

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

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

together. If the sum is equal to or exceeds 1, the quantity wo uld be considered a

55 category 3 quantity. Category 3 quantities of radioactive mate rial do not include the

radioactive material contained in any fuel assembly, subassembl y, 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 s afety and security

equipment, establishing facilities, or developing procedures) t hat 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 determine s 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 t he 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 bene fits against

environmental costs and considerin g available alternatives, that the action called for is 56 the issuance of the proposed license, with any appropriate cond itions to protect

environmental values. Commencement of construction prior to su ch conclusion must be

grounds for denial of a license to receive and possess byproduc t 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 par agraph (e) to read

as follows:

§ 30.41 Transfer of byproduct material.

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

Commission or an Agreement State or to a general licensee who i s 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 th at the transferee's license

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

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

verify the transfer.

(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 acce ptable:

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

30.4:

57 (i) The transferor must verify with the NRCs License Verificat ion System or the

license-issuing authority, prior to conducting such transfer, t hat the transferee's license

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

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

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

earlier than 7 days prior to the transfer.

(ii) In an emergency where the licensee cannot reach the licens e-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 registrat ion certificate number,

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

use of the NRCs License Verification System or by contacting t he 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 certificat ion prepared by the

transferee that the transferee is authorized by license or regi stration certificate to receive

the type, form, and quantity of byproduct material to be transf erred, 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 b e transferred, specifying

the license or registration certificate number, issuing agency and expiration date, 58 provided that the oral certification is confirmed in writing wi thin 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 para graphs (d)(2)(i)

through (iii) of this section are readily available or when a t ransferor 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 licen sing 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 radioactiv e material, as defined

in § 37.5 of this chapter, the requirements set forth in part 3 7 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 l icense issued

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

records showing the receipt, transfer, and disposal of the bypr oduct material, and each

person who transfers byproduct material must keep records showi ng 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 f ollowing transfer to

another licensee or disposal of the material.

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

including the record showing the verification of the transferee s 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. Th e curie (Ci) values specified are obtained by converting from the TBq value. The C i values are provided for practical usefulness only.

Radioactive Category 3 Threshold Material TBq Ci

Americium-241 0.06 1.6

Americium-241

/Be 0.06 1.6

Californium-252 0.02 0.5

Cobalt-60 0.03 0.8

Curium-244 0.05 1.4

Cesium-137 0.1 2.7

Gadolinium-153 1 27

60 Iridium-192 0.08 2.2

Plutonium-238 0.06 1.6

Plutonium-239 0.06 1.6

/Be

Promethium-147 40 1,080

Radium-226 0.04 1.1

Selenium-75 0.20 5.4

Strontium-90 1 27

Thulium-170 20 540

Ytterbium-169 0.30 8.1

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 thus subject to the license verification requirements of this part.

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, 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

61 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

+ ++ 1.0

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

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

Authority: Atomic Energy Act of 1954, secs. 81, 161, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2233, 2273, 2282, 2021); Energy Reorganizati on 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 purs uant 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 w ord must, and removing

the word thereon and adding in its place the words on the de vice;

62

c. In paragraph (c)(2) introductory text, removing the word Sh all 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 i n its place a

period;

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

its place the word Must;

g. In paragraph (c)(4) introductory text, removing the word Sh all 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 semicolo n;

i. In paragraph (c)(4)(ii), removing the text three and addin g 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 addi ng 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 th e word becquerel, and

removing the text GLTS and adding in its place the text Docu ment Control

Desk/GLTS;

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

Must; 63

m. Revising paragraphs (c)(7), (8)(i), and (8)(ii) introductory text;

n. In paragraphs (c)(8)(iii) introductory text and (c)(9) intro ductory 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 beg inning 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 w ill;

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

its place the word Must and removing the word shall and add ing in its place the word

must;

r. In paragraph (c)(13)(ii), removing the word shall, whereve r 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 wo rd shall and adding

in its place the word must;

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

word Must and removing the text GLTS and adding in its plac e 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 de vices and certain

devices for producing light or an ionized atmosphere.

64 (c) * * *

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

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

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

material, as defined in § 30.4 of this chapter, the transfer mu st 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 d evices, the transfer must be

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

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

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

equivalent regulations of an Agreement State, or as otherwise a pproved 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

Desk/GLTS, using an appropriate method listed in § 30.6(a) of t his chapter. The report

must contain

(9) * * *

(i) The device remains in use at a particular location and doe s 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 se ction, a copy of §§ 31.2,

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

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

65 Director, Office of Nuclear Material Safety and Safeguards, ATT N: Document Control

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

(e) Persons possessing byproduct material in devices under a ge neral 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 s ection in effect on January

14, 1975.

(f) Persons possessing devices containing byproduct material gr eater than the

category 3 thresholds listed in table 1 of appendix F to part 3 0 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 fol lows:

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.

66 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 i n 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) * * *

(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 regulati ons of the U.S. NRC or of a

State with which the NRC has entered into an agreement for the exercise of regulatory

67 authority. This label must be maintained on the device in a leg ible 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 manufacture r, or initial

transferor may be omitted from this label provided the informat ion 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 fol lows:

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, 223 3, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 197 4, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Taili ngs Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.

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) thr ough (h),

respectively;

c. Add new paragraph (d); and

d. Revise newly redesignated paragraph (f).

The addition and revision read as follows:

68

§ 40.32 General requirements for issuance of specific licenses.

(d) The applicant has demonstrated (e.g., through installing s afety and security

equipment, establishing facilities, or developing procedures) t hat 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 o ther activity which the

NRC determines will significantly affect the quality of the env ironment, the Director,

Office of Nuclear Material Safety and Safeguards, or the Direct ors 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, afte r weighing the

environmental, economic, technical and other benefits against e nvironmental costs and

considering available alternatives, that the action called for is the issuance of the

proposed license, with any appropriate conditions to protect en vironmental values.

Commencement of construction prior to this conclusion is ground s for denial of a license

to possess and use source and byproduct material in the plant o r facility.

Commencement of construction as defined in § 40.4 may include n on-construction

activities if the activity has a reasonable nexus to radiologic al safety and security.

14. In § 40.51, revise paragraph (d) to read as follows:

§ 40.51 Transfer of source or byproduct material.

69

(d) The following methods for the verification required by par agraph (c) of this

section are acceptable:

(1) The transferor may receive and review a current copy of th e transferee's

specific license or registration certificate;

(2) The transferor may receive and review a written certificat ion by the transferee

that the transferee is authorized by license or registration ce rtificate to receive the type,

form, and quantity of source or byproduct material to be transf erred, specifying the

license or registration certification number, issuing agency an d expiration date. For

transfers that include or consist of a category 3 quantity of r adioactive material, as

defined in § 30.4 of this chapter, the transferor must comply w ith 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 mat erial to be transferred,

specifying the license or registration certificate number, issu ing agency and expiration

date, provided that the oral certification is confirmed in writ ing within 10 days by using

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 t his 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 para graphs (d)(1)

through (3) of this section are readily available or when a tra nsferor 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 licen sing agency of an

Agreement State that the transferee is licensed to receive the source or byproduct 70 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 unde r a license

issued in accordance with the regulations in this part must kee p records showing the

receipt, transfer, and disposal of this source or byproduct mat erial, and each person who

transfers byproduct material must keep records showing the veri fication of the

transferees license, as follows:

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

byproduct material as long as the material is possessed and for 3 years following

transfer to another licensee or disposition of the source or by product material.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

16. The authority citation for part 70 continues to read as follows:

71 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, 2 073, 2077(d), 2138, 2152, 2201, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 202 1, 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;

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 p ursuant 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

72

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 s afety and security

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

special nuclear material for the purposes stated in its applica tion;

(7) Where the applicant is required to submit a summary descri ption of the

fundamental material controls provided in the applicants proce dures for the control of

and accounting for special nuclear material under § 70.22(b), t he applicant's proposed

controls are adequate;

(8) Where the proposed activity is processing and fuel fabrica tion, scrap

recovery, conversion of uranium hexafluoride, uranium enrichmen t facility construction

and operation, or any other activity which the NRC determines w ill significantly affect the

quality of the environment, the Director of Nuclear Material Sa fety 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 informati on 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 en vironmental values.

Commencement of construction prior to this conclusion is ground s for denial to possess 73 and use special nuclear material in the plant or facility. Com mencement of construction

as defined in § 70.4 may include non-construction activities if the activity has a

reasonable nexus to radiological safety and security.

19. In § 70.42, revise paragraphs (c) and (d) and add paragrap h (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 i s 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 th at the transferee's license

authorizes receipt of the type, form, and quantity of special n uclear material to be

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

verify the transfer.

(d) For transfers of special nuclear material other than catego ry 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 acce ptable:

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

30.4 of this chapter:

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

license-issuing authority, prior to conducting such transfer, t hat the transferee's license

authorizes the receipt of the type, form, and quantity of radio active material to be 74 transferred. If the verification is conducted by contacting th e license-issuing authority,

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

earlier than 7 days prior to the transfer.

(ii) In an emergency where the licensee cannot reach the licens e-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 registrat ion certificate number,

license number, current revision number, issuing agency, and ex piration date, provided

that the oral certification is confirmed by use of the NRCs Li cense Verification System or

by contacting the license-issuing authority by the end of the n ext 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 certificat ion by the transferee

that the transferee is authorized by license or registration ce rtificate to receive the type,

form, and quantity of special nuclear material to be transferre d, specifying the license or

registration certificate number, issuing agency, and expiration date.

(iii) For emergency shipments, the transferor may accept an ora l certification by

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

receive the type, form, and quantity of special nuclear materia l to be transferred,

specifying the license or registration certificate number, issu ing agency, and expiration

date, provided that the oral certification is confirmed in writ ing within 10 days by using

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

75 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 para graphs (d)(2)(i)

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

information received by one of these methods is correct or up-t o-date, the transferor may

obtain and record confirmation from the Commission or the licen sing 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 yea rs from the date the record

is made.

(3) The transferor must keep a copy of the verification documen tation 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 3 7 of this chapter apply.

Dated: <Month XX, 20XX>.

For the Nuclear Regulatory Commission.

Brooke P. Clark, Secretary of the Commission.

76