ML22255A036

Proposed Rule: Harmonization of Transportation Safety Requirements with International Atomic Energy Agency Standards (Rin 3150-AJ85; NRC-2016-0179) (STC-22-057)

ML22255A036
Person / Time
Issue date:	09/12/2022
From:	Brooke Clark Office of Nuclear Material Safety and Safeguards, NRC/SECY
To:
Shared Package
ML22234A228	List: ML22234A226 ML22255A036
References
87FR55708, NRC-2016-0179, RIN 3150-AJ85, STC-22-057
Download: ML22255A036 (27)

Text

55708 Proposed Rules Federal Register Vol. 87, No. 175

Monday, September 12, 2022

This section of the FEDERAL REGISTER Forder; telephone: 301-415-3407; I. Obtaining Information and contains notices to the public of the proposed email: Dawn.Forder@nrc.gov. For Submitting Comments issuance of rules and regulations. The technical questions contact the A. Obtaining Information purpose of these notices is to give interested individual or individuals listed in the persons an opportunity to participate in the FOR FURTHER INFORMATION CONTACT Please refer to Docket ID NRC-2016-rule making prior to the adoption of the final section of this document. 0179 when contacting the NRC about rules. the availability of information for this

• Email comments to: action. You may obtain publicly-Rulemaking.Comments@nrc.gov. If you available information related to this NUCLEAR REGULATORY do not receive an automatic email reply action by any of the following methods:

COMMISSION confirming receipt, then contact us at

• Federal Rulemaking Website: Go to 10 CFR Part 71 301-415-1677. https://www.regulations.gov and search

• Mail comments to: Secretary, U.S. for Docket ID NRC-2016-0179.

[NRC-2016-0179] Nuclear Regulatory Commission,

• NRCs Agencywide Documents RIN 3150-AJ85 Washington, DC 20555-0001, ATTN: Access and Management System Rulemakings and Adjudications Staff. (ADAMS): You may obtain publicly-Harmonization of Transportation For additional direction on obtaining available documents online in the Safety Requirements With IAEA information and submitting comments, ADAMS Public Documents collection at Standards see Obtaining Information and https://www.nrc.gov/reading-rm/

Submitting Comments in the adams.html. To begin the search, select AGENCY: Nuclear Regulatory SUPPLEMENTARY INFORMATION section of Begin Web-based ADAMS Search. For Commission. this document. problems with ADAMS, please contact ACTION: Proposed rule and guidance; the NRCs Public Document Room (PDR) request for comment. FOR FURTHER INFORMATION CONTACT: reference staff at 1-800-397-4209, 301-James Firth, 301-415-6628, email: 415-4737, or by email to

SUMMARY

The U.S. Nuclear Regulatory James.Firth@nrc.gov; or Bernard White, PDR.Resource@nrc.gov. For the Commission (NRC), in consultation with 301-415-6577, email: Bernard.White@convenience of the reader, instructions the U.S. Department of Transportation, nrc.gov. Both are staff of the Office of about obtaining materials referenced in is proposing to amend its regulations for Nuclear Material Safety and Safeguards, this document are provided in the the packaging and transportation of U.S. Nuclear Regulatory Commission, Availability of Documents section.

radioactive material. The NRC has Washington, DC 20555-0001.

• NRCs PDR: You may examine and historically revised its transportation SUPPLEMENTARY INFORMATION: purchase copies of public documents, safety regulations to ensure by appointment, at the PDR, Room P1 harmonization with the International Table of Contents B35, One White Flint North, 11555 Atomic Energy Agency standards. These I. Obtaining Information and Submitting Rockville Pike, Rockville, Maryland changes are necessary to maintain a Comments 20852. To make an appointment to visit consistent regulatory framework with A. Obtaining Information the PDR, please send an email to the U.S. Department of Transportation B. Submitting Comments PDR.Resource@nrc.gov or call 1-800-for the domestic packaging and II. Background 397-4209 or 301-415-4737, between transportation of radioactive material III. Discussion 8:00 a.m. and 4:00 p.m. eastern time and to ensure general accord with A. Action the NRC is Proposing To Take (ET), Monday through Friday, except International Atomic Energy Agency B. Applicability of the Proposed Action Federal holidays.

standards. Concurrently, the NRC is C. Discussion of Issues Specific Request for B. Submitting Comments issuing for public comment Draft Comment Please include Docket ID NRC-2016-Regulatory Guide DG-7011, which IV. Specific Request for Comment 0179 in your comment submission.

would become Revision 3 to Regulatory V. Section-by-Section Analysis The NRC cautions you not to include Guide 7.9, Standard Format and VI. Regulatory Flexibility Certification Content of Part 71 Applications for VII. Regulatory Analysis identifying or contact information that Approval of Packages for Radioactive VIII. Backfitting and Issue Finality you do not want to be publicly Material. IX. Cumulative Effects of Regulation disclosed in your comment submission.

X. Plain Writing The NRC will post all comment DATES: Submit comments by November XI. Environmental Assessment and Proposed submissions at https://

28, 2022. Comments received after this Finding of No Significant Environmental www.regulations.gov as well as enter the date will be considered if it is practical Impact comment submissions into ADAMS.

to do so, but the NRC is able to ensure XII. Paperwork Reduction Act The NRC does not routinely edit consideration only for comments XIII. Criminal Penalties comment submissions to remove received on or before this date. XIV. Coordination with NRC Agreement identifying or contact information.

ADDRESSES: You may submit comments States If you are requesting or aggregating by any of the following methods: XV. Compatibility of Agreement State comments from other persons for

• Federal rulemaking website: Go to Regulations submission to the NRC, then you should https://www.regulations.gov and search XVI. Voluntary Consensus Standards inform those persons not to include XVII. Availability of Guidance for Docket ID NRC-2016-0179. Address XVIII. Public Meeting identifying or contact information that questions about NRC dockets to Dawn XIX. Availability of Documents they do not want to be publicly

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disclosed in their comment submission. necessary changes related to SSR-6 in a issue license-specific conditions and Your request should state that the NRC future rulemaking after consulting with exemptions; and Alternative 4-initiate a does not routinely edit comment DOT. rulemaking action to revise 10 CFR part submissions to remove such information The NRC engaged with the DOT in the 71. The alternatives were evaluated before making the comment development of this proposed rule to based on their viability to resolve the submissions available to the public or identify and evaluate gaps between 10 regulatory issues of concern and entering the comment into ADAMS. CFR part 71 regulations and the updated estimates of their costs and potential II. Background IAEA standards in SSR-6, 2018 Edition. benefits. The NRC determined that the This proposed rule would close those rulemaking action, Alternative 4, for On June 12, 2015, the NRC, in gaps where warranted. Harmonizing Issues 1 (in part), 2, and 4-15, in consultation with the U.S. Department NRC regulations with the 2018 Edition combination with the no-action of Transportation (DOT), published a of SSR-6 includes changes made in the alternative, Alternative 1, for Issue 3, final rule that amended the NRCs 2012 Edition of SSR-6 that have been was the NRC-recommended action regulations for the packaging and carried forward to the 2018 Edition. The because it represented the most effective transportation of radioactive material DOT is undertaking a similar initiative and least-costly option. Alternatives 2 (80 FR 33988; June 12, 2015). These to harmonize its regulations in 49 CFR and 3 would not address all of the amendments made conforming changes parts 107 and 171-180 with the 2018 regulatory issues or would result in to the NRCs regulations based on the Edition of SSR-6. higher costs to the NRC and industry.

standards of the International Atomic The NRC reviewed the 2018 Edition The NRC also held a public meeting Energy Agency (IAEA). That final rule, of SSR-6 and identified 10 regulatory on April 30, 2019, to discuss the draft in combination with a DOT final rule issues for harmonization with the IAEA regulatory basis and answer questions.

(79 FR 40589; July 11, 2014) amending and another 4 NRC-initiated changes to The NRC received seven public title 49 of the Code of Federal 10 CFR part 71 to be evaluated during comment submissions on the draft Regulations (49 CFR), brought U.S. the rulemaking development process. regulatory basisthree with general regulations into general accord with the Fourteen of these issues were comments on the rulemaking and four 2009 Edition of the IAEAs Regulations documented in the Issues Paper on with comments on specific issuesas for the Safe Transport of Radioactive Potential Revisions to Transportation well as comments that were considered Material (TS-R-1). The IAEA has since Safety Requirements and Harmonization outside the scope of this proposed rule.

updated its standards for the transport with International Atomic Energy All three general comments were of radioactive material in Regulations Agency Transportation Requirements supportive of the harmonization effort for the Safe Transport of Radioactive (issues paper). The issues paper, public with IAEA SSR-6. The NRC did not Material, Specific Safety Requirements meeting, and request for comment were receive any comments on Issues 2, 6, No. 6 (SSR-6) (2012 and 2018 Editions). published in the Federal Register (81 and 14. The NRC received comments The IAEA develops international FR 83171; November 21, 2016). The supportive of the proposal for Issues 4b, safety standards for the safe transport of NRC held a public meeting on December 11, 12, 13 and 15, along with comments radioactive material. The IAEA safety 5-6, 2016, to discuss the issues paper, supportive of other issues which also standards are developed in consultation and the DOT participated in that public recommended modifications to the with the competent authorities of meeting. A summary of the public NRCs proposed changes. One comment Member States, so they reflect an meeting, including the attendance list, on Issue 5 proposed the NRC add a international consensus on what is was issued on December 14, 2016. After definition of radiation level to 10 CFR needed to provide for a high level of the public meeting, the NRC received 49 part 71, which the NRC included in this safety. By providing a global framework comment submissions on the issues proposed rule.

for the consistent regulation of the paper identified comments that are One comment on Issue 1 stated that transport of radioactive material, IAEA pertinent to this proposed rule, and the fissile exemption mass limits in 10 safety standards facilitate international considered these comments in the CFR part 71 should match those in SSR-commerce and contribute to the safe development of a draft regulatory basis. 6, paragraph 417, to avoid confusion for conduct of international trade involving In addition to the 14 issues documented international shipments from the United radioactive material. By periodically in the paper, the NRC identified other States. The NRC has determined that its revising its regulations to be compatible potential changes to the regulations, regulations for fissile exemption mass with IAEA standards and DOT including clarifications to ensure limits should differ from the IAEAs regulations, the NRC can remove compatibility with the DOT and changes requirements to provide flexibility for inconsistencies that could impede to the compatibility categories for shippers. Specifically, the NRC international commerce. Agreement State regulations. These requirements in this proposed rule The roles of the DOT and the NRC in potential changes were grouped under a would adopt a 3.5-gram limit from SSR-the coregulation of the transportation of new issue that was designated as Issue 6, paragraph 417(c), but without the radioactive materials are documented in 15 in the draft regulatory basis. All 15 associated consignment limit found in a Memorandum of Understanding (44 issues are described in Section III of this paragraph 570(c); they also would adopt FR 38690; July 2, 1979). Because of the document. a higher mass limit than SSR-6, coregulation of the transportation of On April 12, 2019, the NRC published paragraph 417(e). Several existing fissile radioactive materials in the United the draft regulatory basis for this exemptions under § 71.15 do not have States, the NRC and the DOT have proposed rule in the Federal Register corresponding exceptions under SSR-6, historically coordinated to harmonize and requested public comments (84 FR paragraph 417; if the NRC made 10 CFR their respective regulations with the 14898; April 12, 2019). In the regulatory part 71 fissile exemptions identical to IAEA revisions through the rulemaking basis, the NRC evaluated four the fissile exceptions in SSR-6, process. In the NRCs previous 10 CFR alternative actions for each issue. These paragraph 417, fissile material licensees part 71 harmonization rulemaking, were: Alternative 1take no action and would lose the benefit of these published in the Federal Register on maintain the status quo; Alternative 2 exemptions. Also, the NRC is not June 12, 2015, the Commission stated issue generic communications and pursuing the competent authority-that the NRC will consider any regulatory guidance; Alternative 3 approved exception in SSR-6,

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paragraph 417(f). The NRC has One comment on Issue 10 supported advance notification for spent fuel determined that the current fissile phasing out older packages as proposed shipments. The requirements in § 71.97 exemptions under § 71.15 provide in transitional arrangements but currently contain reporting flexibility for shipping low masses or suggested a phase-out period longer requirements that are duplicative with concentrations of fissile materials, and than 4 years. The NRC agreed and is those in 10 CFR part 73, and the NRC licensees can submit a specific proposing an 8-year phase out of older is proposing to delete the duplicative exemption request under § 71.12 for packages. As part of the NRCs 2004 language.

fissile materials that do not meet the amendment to 10 CFR part 71 (69 FR Because none of the comments would fissile exemption criteria in § 71.15. 3697; January 26, 2004), certain result in significant changes to the draft The NRC received comments on transportation packages, those regulatory basis, the NRC considered Issues 4 and 8 which suggested that the compatible with the 1967 edition of these comments in preparing this NRC grandfather packages from Safety Series No. 6, became proposed rule and did not issue a final having to meet the revised unauthorized for use under the 10 CFR regulatory basis.

requirements. The NRC is proposing to part 71 general license after October 1, III. Discussion grandfather older packages as 2008. The NRC received requests to discussed in Issue 10, Transitional extend the phase-out date beyond the A. Action the NRC is Proposing To Take Arrangements. initial 4-year period to allow sufficient The NRC is proposing to amend its Comments on Issue 4 on the proposed time to design, obtain approval for, and regulations to harmonize them with the insolation requirements stated that these fabricate new packages. Given this IAEA international transportation requirements would present challenges experience, in this proposed rule, the standard No. SSR-6 (2018 Edition).

to certificate holders, including cost to NRC has selected a phase-out period of These revisions would be coordinated certificate holders to evaluate the new 8 years to give certificate holders with DOT and its hazardous materials conditions; changing the units without sufficient time to conduct these regulations to maintain a consistent revising the corresponding values may activities, if needed. The NRC estimates framework for the domestic result in decreasing margins or that it could take 2 to 4 years for design transportation and packaging of exceeding thermal limits; and the of a new package and preparation of an radioactive material.

insolation values are referenced in other application, 1 to 2 years for package This proposed rule also would revise documents, which may have an impact approval, and 1 to 2 years for package 10 CFR part 71 to include to the thermal evaluations for storage fabrication, depending on the packages administrative, editorial, or clarifying systems certified under 10 CFR part 72. complexity. Another comment on Issue changes, including changes to certain While the NRC agrees there will be costs 10 on transitional arrangements stated Agreement State compatibility category with evaluating the new insolation that the NRC should not phase out designations that are further discussed requirements, the NRC estimates that packages with a -96 in the package in Section XV, Compatibility of the cost for existing certificates to show identification number and that the Agreement State Regulations, of this compliance with the revised insolation proposed phase out of packages did not document.

will be small, since the increased consider the cost impact for designing B. Applicability of the Proposed Action insolation load would be approximately new packages. The NRC is not 3 percent. In addition, harmonizing proposing to phase out packages with a This action would affect (1) NRC NRC requirements with those of IAEA -96 in the proposed rule, but rather licensees authorized by a Commission-will ensure that packages approved by proposing to phase out packages that do issued specific or general license to the NRC would also be acceptable in not have either a -85 or a -96 in receive, possess, use, or transfer other countries where they might be the package identification number (i.e., licensed material, if the licensee used for international transport. The packages approved before April 1, delivers that material to a carrier for NRC made no changes as a result of this 1996). The NRC included the cost of transport, or transports the material comment. The NRC recognizes that all designing a new package in the outside of the site of usage as specified packages age over time and that aging regulatory analysis for the proposed in the NRC license, or transports that effects should be considered for all rule. material on public highways; (2) holders packages, not just for dual-purpose The NRC received one comment on of, and applicants for, a certificate of packages. Issue 12 on the proposed quality compliance (CoC) under 10 CFR part 71; The NRC received comments on Issue assurance program (QAP) changes, and (3) holders of a 10 CFR part 71 QAP 9 opposing the addition of an aging stating that the proposed change would approval. This action also would change management program to 10 CFR part 71. be duplicative with 10 CFR part 50 QAP requirements that are a matter of The commenters stated that, if such a requirements. The NRC disagrees with compatibility with the Agreement program were added, the program this comment because if a 10 CFR part States. Therefore, the Agreement States should be limited to packages other than 50 licensee uses its 10 CFR part 50 QAP would need to update their regulations, dual-purpose spent nuclear fuel for 10 CFR part 71 activities, the QAP as appropriate, at which time those packages/canisters. The NRC is not reporting requirements in 10 CFR part licensees in Agreement States would proposing to impose a requirement for 50 would be controlling and 10 CFR need to meet the compatible Agreement an aging management plan. The part 71 QAP reporting requirements State regulations.

proposed rule includes requirements would not apply. Also, the NRC notes C. Discussion of Issues that aging effects are evaluated in the that many users of 10 CFR part 71 do application for approval and that the not have 10 CFR part 50 licenses, and The NRC is proposing to revise 10 application for approval include a the 10 CFR part 71 QAP change CFR part 71 as described in the 15 maintenance program. Another provisions would not be duplicative for issues listed in this document and comment on Issue 9 supported them. summarized in the following table (note evaluating aging effects but only for The NRC received a comment on that the issue numbers described in dual-purpose spent fuel packages, Issue 15 on the advance notification Section III.C of this document are excluding packages that are not kept in requirements in § 71.97, stating that consistent with those described in the long-term storage prior to transport. there is no actual provision requiring regulatory basis):

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Issue IAEA harmonization DOT harmonization Other changes No action

1 X 2 X 3 X 4.1 X 4.2 X 5 X 6 X X 7 X X 8 X 9 X 10 X X 11 X X 12 X 13 X 14 X 15.1 X 15.2 X 15.3 X X 15.4 X 15.5 X

Issue 1. Revision of Fissile Exemptions number of consignments that may be the IAEA SSR-6, paragraph 417(e),

The fissile material exemptions in present on a single conveyance. value, the NRC determined that the

§ 71.15 and the fissile material general Additionally, the number of these higher value is technically justified and licenses in §§ 71.22 and 71.23 allow packages does not need to be limited by will be appropriate for NRC licensees licensees to ship low-risk fissile regulation because reaching the amount who ship specific waste streams (e.g.,

material (e.g., small quantities or low required to approach criticality on a decommissioning waste), and that there concentrations) without meeting the single conveyance is not credible. will be little international shipment fissile material packaging requirements The NRC has determined that a mass from the United States of this type of and criticality safety assessments, as value higher than that contained in material. Licensees who ship material specified in §§ 71.55 and 71.59, and IAEA SSR-6, paragraph 417(e), is internationally must comply with DOT without obtaining prior NRC approval. justified, given the conservatism requirements for the use of international For these low-risk fissile material inherent in the exclusive use restriction standards in title 49, Transportation, shipments, the fissile material of the SSR-6 provision, and in basing of the CFR.

exemptions and general licenses the mass limit on plutonium-239 Additionally, the NRC is not provide reasonable assurance that (239Pu), which would have to be proposing to adopt the packaged or criticality safety is afforded under shipped in a Type B package. The NRC unpackaged language in the fissile normal conditions of transport and proposes a limit of 140 grams of fissile exception provision of IAEA SSR-6, hypothetical accident conditions. In material on a conveyance shipped under paragraph 417(e). The 140-gram limit, as 2012, IAEA modified the fissile exclusive use, as another exemption with other fissile exemption provisions exception provisions in SSR-6, under § 71.15. This limit is based on one in § 71.15, only relieves the consignor paragraph 417, to include three new fifth of a minimum critical mass of from having to ship in a Fissile per-package mass limit options, with uranium-235 (235U) (as defined in package, evaluated per the requirements associated mass limits on the American National Standards Institute/ of §§ 71.55 and 71.59. This material is consignment and/or conveyance. American Nuclear Society [ANSI/ANS] still subject to all other radioactive The NRC proposes to incorporate two 8.1-2014 (Reaffirmed 2018), Nuclear materials transportation requirements in additional fissile exemptions under Criticality Safety in Operations with 10 CFR part 71 and in 49 CFR part 173

§ 71.15. This proposed rule would adopt Fissionable Materials Outside and should be packaged accordingly.

the exception in SSR-6, paragraph Reactors) under optimum conditions. The NRC is proposing to make a minor 417(c), without the associated This mass represents a conservative change to § 71.15(d) for clarity and to consignment limit of IAEA SSR-6, limit for fissile material, since five times maintain consistent language paragraph 570(c). This proposed rule this amount would remain subcritical throughout § 71.15.

would also adopt the exception in SSR-under any condition. Additionally, the Issue 2. Revision of Reduced External 6, paragraph 417(e), with its associated limit provides safety equivalent to Pressure Test for Normal Conditions of exclusive use restriction in paragraph packages approved under 10 CFR part Transport 570(e), but with a higher mass limit. 71 and could provide more flexibility Since the amount of fissile material for shipping individual contaminated The regulation at § 71.71(c)(3) allowed by SSR-6, paragraph 417(c), is items or small quantities of fissile requires Type AF and Type B package similar to the existing exemption in material. The NRC considers 235U for designs to be able to withstand a

§ 71.15(a), in terms of reactivity, the this limit rather than 239Pu, as any reduction in external pressure to 25 NRC determined that the consignment amount of 239Pu over 0.435 grams is kilopascals (kPa) (3.6 psia) under limit of IAEA SSR-6, paragraph 570(c), considered Type B, which would have normal conditions of transport. For a is not necessary. Consignment limits, as to be packaged to withstand both Type A package (as defined in SSR-6, provided in 570(c), do not prevent the normal and hypothetical accident paragraphs 231 and 429; 10 CFR 71.4, accumulation of packages on a transport conditions of transport. Although the Definitions; or 49 CFR 173.403, conveyance, as there is no limit to the NRC proposed value is different from Definitions), IAEA SSR-6, paragraph

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645, states that [t]he containment altitudes, the NRC determined that no and to add insolation to the initial system shall retain its radioactive change to § 71.71(c)(3) is needed, and conditions for the tests for hypothetical contents under a reduction of ambient the 25 kPa (3.6 psia) value should be accident conditions in § 71.73(b).

pressure to 60 kPa. This requirement retained. Issue 4.1. Revision of Units for also applies to Type B(U) and Type The NRC also considered adding the Insolation for Normal Conditions of B(M) packages, in accordance with air transport requirements from SSR-6, Transport SSR-6, paragraphs 652 and 667, paragraph 621. However, other than respectively. Additionally, IAEA SSR-6, specific air transport requirements at The units for insolation in 10 CFR paragraph 621, indicates packages § 71.55(f), General requirements for part 71 are gram calories per square containing radioactive material to be fissile material packages and § 71.88, centimeter (g cal/cm2). When the IAEA transported by air shall be capable of Air transport of plutonium, 10 CFR published Safety Series No. 6, withstanding, without loss or dispersal part 71 does not contain mode-Regulations for the Safe Transport of of the radioactive contents from the specific regulations. Because the Radioactive Material, 1985 Edition, it containment system, an internal existing reduced external pressure test revised the units used for insolation for pressure that produces a pressure value covers air transport conditions as normal conditions of transport from a differential of not less than maximum discussed above, and because of the hybrid of English and metric units (g normal operating pressure plus 95 kPa robustness of Type AF and Type B (13.8 psi). packages, as compared to Type A cal/cm2) to metric units (watts per In a final rule published by the DOT packages, the NRC finds it unnecessary square meter (W/m2)). When the IAEA (79 FR 40589; July 11, 2014), the DOT to add the mode-specific air transport changed the units, it chose to keep the harmonized its regulations in 49 CFR requirements from SSR-6, paragraph same numerical values, thus increasing chapter I to the 2009 Edition of IAEA 621, into 10 CFR part 71. the evaluated solar heat load on a TS-R-1. In that final rule, the DOT Based on the above considerations package by approximately 3 percent.

explained that a Type A package must and assessments, the NRC has decided The IAEA did not provide a technical be designed to ensure the package can not to pursue any changes to rationale for this change; however, the retain its contents under the reduction § 71.71(c)(3). As a result, no further NRC observes that retaining the existing of ambient pressure. That ambient discussion or analysis is presented in numerical quantities maintains simple pressure value, found at 49 CFR this proposed rule on the reduced (round) values in the regulations that 173.412(f), was changed from 25 kPa external pressure test for normal result in a small change in solar heat (3.6 psia) to 60 kPa (8.7 psia). conditions of transport. load.

The NRC considered whether it Issue 3. Inclusion of Type C Package The NRC previously harmonized its should change the reduced external Standards regulations with the 1985 Edition of pressure test requirement in Safety Series No. 6 (60 FR 50248;

§ 71.71(c)(3) to harmonize with the In the 2004 final rule, the NRC did not September 28, 1995). That final rule IAEA transport standards and to be adopt the regulations for Type C neither discussed nor proposed consistent with the DOT regulations for packages contained in IAEA TS-R-1. changing the units on the heat test for design requirements for Type A The NRC did not adopt them because 1) normal conditions of transport in packages. The NRC assessed the §§ 71.64 and 71.74 for plutonium air potential impacts of the change in the transportation contain more rigorous § 71.71(c)(1). Consequently, the current external pressure value from 25 kPa (3.6 packaging standards, 2) the NRC units for insolation in 10 CFR part 71 psia) to 60 kPa (8.7 psia) and the perceived no need (current or are g cal/cm2. This is inconsistent additional air transport requirements anticipated) for such packages, and 3) if with IAEA standards in the 2018 from SSR-6, paragraph 621. The current a need arose for import or export, it Edition of SSR-6. As a result, NRC NRC reduced external pressure test could be accomplished through the DOT package approvals are evaluated for less requirement, 25 kPa (3.6 psia), equates regulations. insolation than that prescribed by IAEA to an altitude of about 35,000 feet In the request for comment on the standards and evaluated for approval by (10,668 meters) above sea level, which issues paper, the NRC asked foreign competent authorities.

is an appropriate altitude for air stakeholders whether there was a need The NRC is proposing to revise the transport of packages. Since cargo for domestic transport of Type C units of insolation for the heat test for planes use pressurized cargo holds packages. No NRC licensees expressed a normal conditions of transport in during air transport, this external need for domestic transport of Type C § 71.71(c)(1) to match the units used in pressure value also represents the packages. Therefore, the NRC has the 2018 Edition of SSR-6 to ensure that ambient pressure on a package should decided not to pursue further changes to NRC requirements for insolation are the cargo hold depressurize. Whereas Type C package standards as consistent with the IAEA standard.

the 60 kPa (8.7 psia) value equates to an contemplated in the regulatory basis Consistent with Issue 10, Transitional altitude of about 14,040 feet (4,279 document. As a result, no further Arrangements, the NRC would not meters) above sea level. Thus, while the discussion or analysis is presented in expect a certificate holder to evaluate 60 kPa (8.7 psia) external pressure value this proposed rule on that issue. the higher solar heat load unless it equates well with the highest paved Issue 4. Revision of Insolation requests a revision of its certificate to road in the United States (14,130 feet Requirements for Package Evaluations show compliance with the revised (4,307 meters)) and with the elevation of transportation regulations in 10 CFR the highest operating freight railroad in During transport, a package is the United States (La Veta Pass at 9,242 subjected to heating by the sun, called part 71. Additionally, given the small feet (2,817 meters)), it would not insolation. The effect of insolation is an increase in insolation due to the revised support air transport conditions, as increase in the package temperature. units, the NRC expects that certificate cargo planes operate at higher altitudes. The NRC is proposing to change the unit holders will be able to show compliance When comparing the current 25 kPa (3.6 of measure for the values of insolation with the package approval standards in psia) value with the proposed 60 kPa used for the heat test for normal subpart E, Package Approval (8.7 psia) value, and the associated conditions of transport in § 71.71(c)(1), Standards, to 10 CFR part 71.

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Issue 4.2. Inclusion of Insolation for the current regulations in 10 CFR part inhalation risk is used to determine the Hypothetical Accident Conditions 71 use the term radiation level, the average specific activity limits for both In Safety Series No. 6, Regulations NRC is concerned that using a different LSA-II and LSA-III material, which are for the Safe Transport of Radioactive term from the IAEA to define external 10¥4A2/g and 2 x 10¥3A2/g, Material, 1985 Edition (As Amended radiation standards could create some respectively. Related investigations 1990), paragraph 628 stated, With confusion with respect to international dating back to 2003 revealed that the respect to the initial conditions for the shipments. amount of released radioactive material thermal test, the demonstration of Additionally, NRC regulations in 10 leading to an inhalation dose under the compliance shall be based upon the CFR part 20, Standards for Protection mechanical tests for normal conditions assumption that the package is in Against Radiation, include a definition of transport greatly depend on the equilibrium at an ambient temperature for dose equivalent in § 20.1003 that physical form of the LSA material. The of 38 °C. The effects of solar radiation means the product of the absorbed dose primary difference between LSA-II and may be neglected prior to and during in tissue, quality factor, and all other LSA-III materials is that LSA-III is the tests, but must be taken into account necessary modifying factors at the limited to solid material, excluding in the subsequent evaluation of the location of interest. The units of dose powders. Due to the solid nature of the package response. equivalent are the rem and sievert (Sv). LSA-III material, the amount of airborne The thermal test, previously in The NRC considered replacing the radioactivity released during the paragraph 628, was moved to paragraph term radiation level used throughout mechanical tests for normal conditions 728 in the 1996 Edition of TS-R-1 and 10 CFR part 71 with dose equivalent of transport leading to an inhalation revised to state, The specimen shall be rate. However, this change would dose is at least a factor of 100 lower for in thermal equilibrium under conditions result in cost impacts to licensees to LSA-III solids than for LSA-II solids in of an ambient temperature of 38 °C, change documentation and training powder form. This much lower airborne subject to the solar insolation conditions programs with no safety benefit. release for LSA-III material due to its specified in Table XI and subject to the Therefore, in order to minimize the non-readily dispersible form outweighs design maximum rate of internal heat burden to licensees, the NRC is the difference in average specific generation within the package from the proposing to add a definition to § 71.4 activity limit, which is 20 times greater radioactive contents. that clarifies that radiation level for LSA-III compared to LSA-II material When the NRC revised its regulations means dose equivalent rate, which in powder form. Because of the non-in 2004 to harmonize with the 1996 enables the NRC to continue using dispersible form of the LSA-III material, IAEA standards (69 FR 3697; January radiation level throughout 10 CFR the working group determined that there 26, 2004), the NRC did not revise the part 71. The NRC is not expecting any was no need to take credit from a initial conditions of the fire test listed licensee to change its documentation to leaching test to justify this allowable 20-in § 71.73(b) to require evaluation of account for this new definition. fold increase in average specific activity insolation as an initial condition. Issue 6. Deletion of Low Specific between LSA-III and LSA-II material.

Since a fire can occur on a hot, sunny Activity-III Leaching Test The NRC recognizes the working day, and to be consistent with IAEA The definition for Low Specific groups information, and is standards, the NRC is proposing to Activity (LSA) material in § 71.4 recommending harmonization with revise the initial conditions in § 71.73(b) includes three categories of material: SSR-6, 2018 Edition, and removal of the to require insolation as an initial LSA-I, LSA-II, and LSA-III. leaching test from 10 CFR part 71. The condition for all the tests for Radioactive material, low specific NRC agrees that requiring the LSA-III hypothetical accident conditions. activity category III (i.e., LSA-III) leaching test does not increase the safety Consistent with Issue 10, Transitional includes solids, excluding powders, that of the material during transport.

Arrangements, the NRC would expect meet the requirements in § 71.77, Further, the test does not decrease the Qualification of LSA-III material and inhalation pathway exposure when a certificate holder to evaluate the compared to LSA-II material in powder revised initial conditions in § 71.73 if it which have an estimated average form, and therefore should be removed wants to revise its certificate to show specific activity limit that does not from 10 CFR part 71. The NRC compliance with the revised exceed 2 x 10¥3 times the A2 value per considered the information provided by transportation regulations in 10 CFR gram (A2/g). The qualification tests in the LSA-II and LSA-III working groups part 71. § 71.77 include a leaching test with and comments received on this issue Issue 5. Inclusion of Definition for immersion of the specimen material for during the comment period on the Radiation Level 7 days. The IAEA eliminated the LSA-NRCs issues paper. Additionally, the III leaching test in SSR-6, 2018 Edition, NRC considers that removal of the The term radiation level was first from paragraphs 409, 601, and 701. leaching test also would reduce introduced in the IAEA transport Consequently, the NRC is proposing regulatory burden for shippers, while standards in Safety Series No. 6, 1973 corresponding revisions to §§ 71.4, still maintaining reasonable assurance Edition, and it was defined in terms of 71.77, and 71.100, Criminal penalties, of safety for transport of LSA-III dose-equivalent rate as the to remove the leaching test and its material.

corresponding radiation dose-equivalent references. The NRC is proposing to remove the rate expressed in millirem per hour. In April 2015, an international leaching test in § 71.77 and make External radiation standards were working group meeting was conducted conforming changes to §§ 71.4 and defined in terms of radiation levels in to discuss issues related to LSA-II and 71.100, which both reference § 71.77.

each subsequent edition of the IAEAs LSA-III material, with special attention Issue 7. Inclusion of New Definition for transport standards, including the 2012 on the need for the LSA-III leaching Surface Contaminated Object Edition of SSR-6. In the 2018 Edition of test. The need for the leaching test was SSR-6, the IAEA replaced the term questioned because the working group As more nuclear facilities begin radiation level with the term dose determined that the test has no bearing decommissioning activities, there will rate and defined the dose rate to be the on the inhalation risk of exposure to be an increase in the number of dose-equivalent per unit time. Because material during transport. The shipments of radioactive materials from

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these facilities. Decommissioning certain uranium hexafluoride (UF6) The 30-inch UF6 cylinder, the most activities can include transporting large packages from the requirements of commonly used cylinder to transport radioactive objects (e.g., steam § 71.55(b). The exception allows UF6 large quantities of enriched UF6 for the generators, coolant pumps, and packages to be evaluated for criticality fuel fabrication industry, has two pressurizers). Under current NRC safety without considering inleakage of penetrations: one for the valve at the top regulations, shipment of such large, water into the containment system, to fill the cylinder and one for the drain nonstandard packages that do not meet provided certain conditions are met, plug at the bottom used during the existing definition of surface including that the uranium is enriched maintenance. In order to ensure contaminated objects (i.e., either SCO-to not more than 5 weight percent in criticality safety, both the plug and the I or SCO-II, as defined in § 71.4) could 235U. To use this exception, the valve must remain leak tight after the be addressed through a special package applicant must demonstrate, among tests for hypothetical accident authorization under § 71.41(d). other things, that, following the tests for conditions to prevent ingress of water However, such an authorization may hypothetical accident conditions in into the cylinder. While this may be a take significant time. The NRC proposes § 71.73, there is no physical contact new requirement in transportation to add a regulatory definition for SCO-between the valve body and any other regulations, during package approval, III to include these types of objects, component of the packaging, other than the NRC has always verified that the allowing a shipper to more at its original point of attachment, and entire 30B cylinder remained leak tight appropriately categorize the item it is the valve remains leak tight. Leaktight after the tests for hypothetical accident planning to transport. The NRC is defined in ANSI N14.5-2014, conditions.

anticipates an increase in efficiency for American National Standard for The NRC is proposing to revise both the NRC and licensees when the Radioactive MaterialsLeakage Tests § 71.55(g)(1) to require that there is no SCO-III definition is included in 10 on Packages for Shipment, as [t]he contact between the cylinder plug and CFR part 71 when compared to the degree of package containment that, in any other part of the packaging, other special package authorization review a practical sense, precludes any than at its original attachment point and needed under § 71.41(d). Harmonization significant release of radioactive that the cylinder plug remains leak with SSR-6, 2018 Edition, would add materials. This degree of containment is tight, as NRC requires for the cylinder the new SCO-III category and the achieved by demonstration of a leakage valve.

associated definition. rate less than or equal to 1 x 10¥7 Issue 9. Inclusion of Evaluation of Aging In the 2004 final rule (69 FR 3697; ref*cm3/s, of air at an upstream pressure Mechanisms and a Maintenance January 26, 2004), the NRC determined of 1 atmosphere (atm) absolute (abs), Program that special package authorizations were and a downstream pressure of 0.01 atm The NRC regulations do not explicitly necessary because there were no abs or less. require that a package application regulatory provisions in 10 CFR part 71 The NRC provided the specific include an evaluation of aging concerning large, nonstandard packages exception: (1) to be consistent with the considered for transportation. Therefore, worldwide practice and limits mechanisms and a maintenance the NRC added paragraph (d) to § 71.41. established in national and international program. Rather, applicants include an Since that time, the NRC has gained standards (ANSI N14.1-2012, Nuclear evaluation of aging effects on package experience with the safety aspects of MaterialsUranium Hexafluoride components to ensure there is no shipping these types of large, non-Packagings for Transport, and significant degradation in accordance standard packages. For example, in International Organization for with § 71.43(d). The NRC regulations at 2006, the LaCrosse reactor vessel was Standardization 7195, Packaging of § 71.43(d) require that packages be made the first shipment in which a package Uranium Hexafluoride (UF6) for of materials and construction that assure was approved under § 71.41(d). In Transport) and DOT regulations (49 that there will be no significant addition, a special package CFR 173.417(b)(5)); (2) because of the chemical, galvanic, or other reaction authorization was issued for the West history of safe shipment; and (3) (including effects of irradiation from the Valley Melter Package from the West because of the essential need to package contents) among the packaging Valley Demonstration Project. In the transport the commodity. In that final components, among package contents, future, a licensee shipping large rule, the NRC codified its long-standing or between the packaging components radioactive objects that have been practice to not consider water inleakage and the package contents, including determined to meet the definition of into UF6 packages as long as the possible reaction resulting from SCO-III would not need NRC review documentation of the results of the tests inleakage of water, to the maximum and approval for a special package for hypothetical accident conditions credible extent.

authorization. tests at § 71.73 show that the cylinder For those components where aging is Both the NRC and DOT intend to add valve was not affected. detrimental to package performance, a definition for SCO-III. The NRC is In SSR-6, 2018 Edition, the IAEA applicants provide a description of the coordinating with the DOT to align its added the same standard for the plug as maintenance program, including definition with the DOTs, since the was added in the 1996 Edition of TS-periodic testing to evaluate the DOT is the lead agency for review and R-1 for the valve to ensure that the components efficacy and/or a evaluation of both LSA and SCO entire cylinder remains leak tight. The replacement or repair schedule, to material. revised paragraph 680(b)(i), SSR-6, mitigate those detrimental effects. The Issue 8. Revision of Uranium 2018 Edition, states: Packages where, NRC requires that licensees and CoC Hexafluoride Package Requirements following the tests prescribed in para. holders follow the maintenance 685(b), there is no physical contact program, which is provided in the In the 2004 final rule (69 FR 3697; between the valve or the plug and any application for approval, as a condition January 26, 2004), the NRC harmonized other component of the packaging other of approval in the CoC. Additionally, its regulations with the 1996 Edition of than at its original point of attachment NRC regulations at § 71.87(b) require IAEA TS-R-1. In that final rule, the and where, in addition, following the that, prior to each shipment, the NRC added a new provision, § 71.55(g), test prescribed in para. 728, the valve licensee ensures that the package is in to provide a specific exception for and the plug remain leaktight. unimpaired physical condition except

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for superficial defects such as marks or number were approved to NRC some additional restrictions on approval dents. Meeting this regulation, along regulations compatible with the and fabrication. The IAEAs SSR-6, with the scheduled periodic tests and provisions of the 1985 or 1985 (as 2018 Edition, prohibits fabrication of replacement/repair in the maintenance amended 1990) Editions of Safety Series special form radioactive material that program, should identify package No. 6. NRC packages with a -96 in the received unilateral approval under the deterioration prior to age-related package identification number were 1985 Edition of Safety Series No. 6 or degradation becoming a safety issue approved to NRC regulations compatible 1985 (as Amended 1990) Edition of during transport. with the 1996 Edition of TS-R-1. Safety Series No. 6. Also, after In paragraph 613A, SSR-6, 2018 The IAEA updated its transitional December 31, 2025, IAEA standards Edition, the IAEA added that package arrangements in paragraphs 819-823, prohibit new fabrication of special form design evaluations must consider aging SSR-6, 2018 Edition, for packages that radioactive material sources to a design mechanisms. In paragraph 809, SSR-6, have a -85 or -96 in their package that had received unilateral approval 2018 Edition, the IAEA added that the identification number. However, it does under the 1996 Edition; 1996 Edition application for package approval must not include transitional arrangements (Revised); 1996 (as Amended 2003) contain a maintenance program. for package designs approved under the Edition of TS-R-1; TS-R-1, 2005 Because an evaluation of aging effects IAEAs 1973 Edition of Safety Series No. Edition; TS-R-1, 2009 Edition; and and a description of the maintenance 6, Regulations for the Safe Transport of SSR-6, 2012 Edition.

program are not specifically required by Radioactive Materials. The NRC Finally, in paragraphs 832-833, SSR-10 CFR part 71, the NRC is proposing previously harmonized its requirements 6, 2018 Edition, the IAEA revised the to revise § 71.43(d) to specifically with the 1973 Edition; corresponding package identification number in the include the evaluation of the effects of packages are those for which the CoC CoC to delete the year designation (i.e.,

aging, and add a new provision to does not have a year designation in the -85 or -96) for those package subpart D, Application for Package package identification number. By not designs that are approved to SSR-6, Approval, to include a description of including transitional arrangements on 2018 Edition.

the maintenance program in an these packages, the IAEA standards In the 2004 final rule (69 FR 3698; application for package approval, to effectively phase out the use of these January 26, 2004), the NRC adopted the better align with these standards in packages approved under the 1973 following grandfathering provisions in SSR-6, 2018 Edition. Edition of Safety Series No. 6. § 71.19 for previously-approved Issue 10. Revision of Transitional The IAEAs SSR-6, 2018 Edition, also packages:

Arrangements prohibits, after December 31, 2028, the

• Packages approved under NRC fabrication of new packagings that have regulations that were compatible with Historically, IAEA standards and DOT not been shown to meet SSR-6, 2018 the provisions of the 1967 Edition of and NRC regulations have included Edition standards. This means that Safety Series No. 6 may be used for a transitional arrangements when the package designs approved to earlier 4-year period after adoption of the final regulations have undergone revision. versions of IAEA standards (i.e., NRC-rule, presuming fabrication was The purpose is to minimize the costs approved packages for which the CoC completed by August 31, 1986; and impacts of implementing changes in has a -96 in its package identification

• Packages approved under NRC the regulations, since package designs number), could not be used unless regulations that became effective on and special form sources that are fabrication is completed before January September 6, 1983 (see 48 FR 35600; compliant with the existing regulations 1, 2029. Note that IAEA standards and August 5, 1983), which are compatible do not become unsafe when the NRC regulations already prohibit the with the provisions of the 1973 or 1973 regulations are revised (unless a use of packages that have -85 in their (as amended) Editions of Safety Series significant safety issue is corrected in package identification number on the No. 6, may no longer be fabricated, but the revision). CoC if their fabrication was not may still be used; Typically, the transitional completed by December 31, 2006.

arrangements include provisions that The IAEAs SSR-6, 2018 Edition, also

• Packages approved under NRC allow for (1) continued use of existing phases out certain special form regulations that are compatible with the package designs and packagings already radioactive material. The NRC provisions of the 1985 or 1985 (as fabricated; and completion of regulations contain a definition of, and amended 1990) Editions of Safety Series packagings in the process of being the tests for, special form radioactive No. 6, and designated as -85 in the fabricated, although some restrictions material. Special form radioactive package identification number, may not on fabrication of packagings approved to material is either a non-dispersible solid be fabricated after December 31, 2006, earlier editions of the regulations may or sealed in a capsule so that the but may still be used; and be imposed; (2) restriction on dispersibility, and therefore the

• Package designs approved under modifications to package designs radiological hazard, of the radioactive any pre-1996 IAEA standards (i.e., NRC without the need to demonstrate full material is diminished. In order to be packages with an -85 or earlier compliance with the revised designated as special form, the package identification number) may be regulations; (3) changes in packaging radioactive material must be evaluated resubmitted to the NRC for review identification numbers; and (4) changes using the tests and acceptance criteria in against the current NRC regulations. If to the fabrication and use of special § 71.75. the package design described in the form sources approved to earlier Paragraph 823 of SSR-6, 2018 resubmitted application meets the versions of the regulations. Edition, does not include provisions for current NRC regulations, the NRC may The NRC CoCs include a package use of special form radioactive material issue a new CoC for that package design identification number which identifies approved under 1973 Edition of Safety with a -96 designation in the package the NRC regulations and the Series No. 6. In SSR-6, 2018 Edition, identification number.

corresponding version of IAEA special form radioactive material that In that same 2004 rulemaking, the standards to which the package was was shown to meet the provisions of the NRC did not revise its grandfathering approved. For example, packages with a 1985 through 2012 Editions of IAEA provisions on special form radioactive

-85 in the package identification standards may continue to be used, with material in § 71.4 because NRC

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regulations were already consistent with packaging was completed after The NRCs requirement in § 71.87(d) the 1996 Edition of TS-R-1. December 31, 2028, and require is compatible with the DOTs The NRC rulemaking in 2015 (80 FR multilateral approval (as defined in 49 regulations at 49 CFR 173.24(h)(1),

33988; June 12, 2015) made two minor CFR 173.403, Definitions) for General requirements for packagings changes to the transitional arrangements packages to be used for international and packages. That regulation requires:

regulations. First, the grandfathering shipment after December 31, 2025. When filling packagings and provision that was in § 71.19(a) for Revise § 71.17(e) to state that packages receptacles for liquids, sufficient ullage packages approved under NRC with a -96 in the package (outage) must be left to ensure that standards that were compatible with the identification number would become neither leakage nor permanent provisions of the 1967 Edition of Safety previously approved packages and distortion of the packaging or receptacle Series No. 6 was deleted since that subject to the current § 71.19(c). will occur as a result of an expansion of provision expired on October 1, 2008. 3. Coordinate with the DOT and make the liquid caused by temperatures likely Second, the definition of special form appropriate changes to § 71.4 to align to be encountered during radioactive material was revised to with the definition of special form transportation.

allow special form radioactive material radioactive material that the DOT is The DOTs regulations in 49 CFR that was successfully tested using the proposing to adopt as part of their 173.412(k), Additional design current requirements of § 71.75(d) to harmonization rulemaking, since DOT is requirements for Type A packages, continue to qualify as special form the lead for certifying special form contain a general design requirement for radioactive material, if the testing was sources. The NRC is proposing to allow Type A packages designed to contain completed before September 10, 2015. continued use of special form liquids to ensure that packages provide Consistent with past practices, the radioactive material that was approved for ullage to accommodate variations in NRC is proposing transitional to the regulations in effect from October temperature of the contents. The term arrangements to phase out older 1, 2004 to the effective date of this ullage refers to the unfilled space in packages without a -85 or -96 in rulemaking, provided they are a container, or the amount by which the the package identification number, and fabricated on or before December 31, contents of a container fall short of limit use of packages with a -96 to 2025. being full. Because DOTs regulations those whose fabrication has been 4. Allow for package designs with a for Type AF, Type B, and Type BF completed by December 31, 2028, and -96 or earlier package identification packages refer to the NRCs regulations, consistent with DOT, limit fabrication of number to be resubmitted to the NRC for DOTs regulations do not contain design special form sources. The NRC review against the current standards. If requirements for Type AF, Type B, or determined that it is appropriate to the package design described in the Type BF packages. Type A, Type AF, begin a phased discontinuance of these resubmitted application meets the Type B, and Type BF packages are older packages to further harmonize current standards, the NRC may issue a defined in § 71.4, Packages.

NRCs regulations with the IAEA new CoC for that package design The IAEA standards in paragraph 649, standards in SSR-6, 2018 Edition. The without a year designation. SSR-6, 2018 Edition, require that The DOT supports this discontinuation and The NRC notes that the IAEA design of a package intended for liquid coordinated with the IAEA on the eliminated the approval year in the radioactive material shall make update to its standards. While the NRC package identification number for provision for ullage to accommodate has not identified safety issues that packages approved to SSR-6, 2018 variations in the temperature of the necessitate the discontinuation of these Edition. Packages that were approved to contents, dynamic effects and filling older packages, they are no longer NRC regulations harmonized with the dynamics.

acceptable in jurisdictions that use the 1973 Edition of Safety Series No. 6 do The NRC regulations have an IAEA requirements. The NRC views that not have a year designation in the operational requirement in § 71.87(d) to the advantages of consistent approvals package identification number. To avoid ensure that for a system containing across jurisdictions outweigh the value confusion regarding these older liquid, there is sufficient head space, or of retaining the authorization for these packages, the NRC would revise all other specified provision to packages. The approach being taken is existing CoCs that do not have a -85 accommodate the expansion of liquid.

consistent with the NRCs 2004 or -96 in their package identification The NRC does not, however, have a rulemaking. Given this experience, the number to add a provision that those comparable design requirement for Type NRC does not expect that certificate CoCs cannot be renewed beyond the end AF and Type B packages in 10 CFR part holders will have challenges showing date of the 8-year phase out period 71 to that in DOTs regulations. Even compliance with the regulations in without being recertified to the revised though the NRCs regulations do not effect at the time the application is version of 10 CFR part 71. include a comparable design submitted for revision. Issue 11. Inclusion of Head Space for requirement for ensuring sufficient The NRC is proposing to revise its Liquid Expansion space to allow for liquid expansion, any transitional arrangements to be Type AF or Type B package design consistent with the IAEA, as follows: The NRCs regulation in § 71.87, certified by the NRC must comply with

1. Phase out the use of packages Routine determinations, requires that § 71.87 and DOT regulations in 49 CFR approved to NRC regulations that were before each shipment of licensed 173.24(h) on ullage when being filled.

harmonized with the IAEAs 1973 material, the licensee must ensure that During review of applications for Edition and 1973 (as Amended) Edition the package, which includes its either a new CoC or an amendment to of Safety Series No. 6, 8 years after the contents, satisfies the applicable an existing CoC, the NRC reviews effective date of this rulemaking. These requirements of part 71. One such whether the requirements in § 71.87(d) packages would be required to be requirement is that the licensee must are reflected in the operating procedures recertified, removed from service, or determine in accordance with § 71.87(d) for packages with liquid contents. Each used via exemption. that any system for containing liquid is package approval issued by the NRC

2. Prohibit the use of packages with a adequately sealed and has adequate contains a condition to ensure that the

-96 in the package identification space or other specified provision for package is prepared in accordance with number for which fabrication of the expansion of the liquid. the operating procedures in the

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application. This ensures that all approval. QAP changes that would reporting requirements in 10 CFR part package users, whether NRC licensees reduce commitments require prior NRC 71 would be consistent with those in or not, comply with the requirements approval. §§ 50.54(a)(3) and 50.71(e)(2) for 10 CFR listed in § 71.87, as appropriate for the In addition, § 71.106 requires that part 50 QAPs. Since the 2015 final rule package design. changes to QAPs that do not reduce became effective, the NRC has received Although the NRC regulations ensure commitments must be submitted to the questions and concerns from industry that adequate ullage exists, the NRC has NRC every 24 months. That final rule on this subject since the language in received on occasion an application that also specified, If a quality assurance § 71.106 does not state that QAP did not evaluate whether there was program approval holder has not made approval holders must report even if sufficient design space in a container any changes to its approved quality there were no changes in the prior 24-with liquids. To clarify this assurance program description during month period.

requirement, the NRC is proposing to the preceding 24-month period, the The NRC is proposing to revise revise § 71.43, General standards for all approval holder will be required to § 71.106(b) to clarify that a biennial packages, to add a design requirement report this to the NRC (80 FR 33994). report must be submitted to the NRC for a package designed to contain In addition, the NRCs guidance even if no changes are made to the QAP liquids to ensure adequate ullage during document for 10 CFR part 71 QAPs, during the reporting period.

evaluation of the tests and conditions Regulatory Guide 7.10, Revision 3, was Issue 13. Deletion of Type A Package for normal conditions of transport and updated in conjunction with the 2015 Limitations in Fissile Material General hypothetical accident conditions. final rule to state that if no changes were Licenses Issue 12. Revision of Quality Assurance made to the QAP, a QAP approval Program Biennial Reporting holder would indicate to the NRC that The general license criteria in § 71.22 Requirements no changes were made. allow NRC licensees to ship small The requirement for a report, even if quantities of fissile material in packages On June 12, 2015, the NRC issued a no changes were made during the that have been assigned a criticality final rule (80 FR 33988), updating the preceding 24-month period, is necessary safety index (CSI) to ensure administrative procedures for the QAP as the NRC inspection program for 10 accumulation control for packages on a requirements described in 10 CFR part CFR part 71 QAP approval holders conveyance. The provisions of § 71.22 71, subpart H, Quality Assurance. relies on having current information require that (1) the fissile material is in Specifically, the NRC added § 71.106 to about the QAP available to the NRC. a Type A package that meets the establish requirements for QAP changes The NRC considers the 24-month requirements of 49 CFR 173.417(a); (2) and associated reporting requirements. reporting requirement, including when licensees have an NRC-approved QAP Previously, all changes made to QAP no changes are made, as providing an satisfying the provisions of 10 CFR part approvals had to be reviewed and appropriate balance between the burden 71, subpart H; (3) there is no more than approved by the NRC before they could placed on the QAP approval holders a Type A quantity of radioactive be implemented. The provisions in and the need to ensure that the NRC has material; (4) there is less than 500 grams

§ 71.106 allow changes to QAPs that do current information for its oversight of total of beryllium, graphite, or not reduce commitments, such as those these QAPs. Most QAP approval holders hydrogenous material enriched in that involve administrative subject to periodic inspection are deuterium; and (5) the package is improvements and clarifications, inspected every 5 years or on an as-labeled with a CSI that meets the limits spelling corrections, and non-needed basis. Another benefit to in § 71.22(d). The regulation in substantive changes, to be made and receiving a report even when no QAP § 71.22(e)(1) provides an equation to implemented without prior NRC changes have been made is that the QAP calculate package CSI:

where X, Y, and Z are mass limits of 235U, control for packages on a conveyance. radioactive material; (4) there is less 233U, and plutonium obtained from The provisions of § 71.23 require that (1) than 1,000 grams of plutonium, Table 71-1 (if 233U or plutonium are the fissile material is in a Type A provided that the total amount of 239Pu present) or Table 71-2. package meeting the requirements of 49 and 241Pu constitutes less than 240 Similarly, the general license criteria CFR 173.417(a); (2) licensees have an grams of the plutonium in the package; in § 71.23 allow NRC licensees to ship NRC-approved quality assurance and (5) the package is labeled with a CSI small quantities of special form program satisfying the provisions of 10 that meets the limits in § 71.23(d). The plutonium in packages that have been CFR part 71, subpart H; (3) there is no regulation in § 71.23(e)(1) provides an assigned a CSI to ensure accumulation more than a Type A quantity of equation to calculate package CSI:

The calculations that support the reflection, i.e., optimally moderated higher for the two fissile plutonium mass limits in § 71.22 include spheres of 235U, 233U, and 239Pu with isotopes, as the material is special form conservative assumptions regarding full water reflection. The mass limits in and will not redistribute significantly.

neutron moderation and water § 71.23 have a similar basis, but are In both cases, it is assumed that the

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material will remain in the package authorized under one of these general 71.23 to ship Type A material in only under normal conditions of transport licenses. a Type A package (i.e., allowing because of the Type A package While NRC is not proposing to revise shipment of material up to the mass requirement but can reconfigure outside §§ 71.22(b) and 71.23(b), which require limits in a Type B package); to add three of the package under hypothetical that the licensee have an NRC-approved new paragraphs in §§ 71.22 and 71.23; accident conditions. The limitation to a QAP. Applications for QAP approvals and to make conforming changes to Type A quantity of radioactive material use a graded approach, based on the § 71.0(d)(1). Additionally, the NRC is in a Type A package, however, is not planned activities and shipments that a proposing to clarify that only special consistent with the mass limits for some licensee plans to make. For example, if form sealed sources, not just sealed fissile nuclides in some cases (e.g., the a licensee has a QAP that was approved sources may be delivered to a carrier for mass limits for 239Pu in Table 71-1 are for making only Type A shipments transport using the general license in 37 grams or 24 grams, depending on the under § 71.22 or § 71.23, then the § 71.23.

degree of moderation, while the A2 licensee would need to obtain Issue 14. Deletion of 233 U Restriction in value for 239Pu is equivalent to 0.435 additional NRC approval for a QAP that Fissile General License grams). In addition, the requirement in includes QA items necessary for making

§ 71.23 does not consistently refer to Type B shipments. The general license criteria in § 71.22 special form sealed sources in that In addition, because the NRC is allow NRC licensees to ship small paragraph (a) also refers to Pu-Be sealed proposing to authorize shipments of quantities of fissile material in packages sources. While all special form sources Type B packages in §§ 71.22 and 71.23, that have been assigned a CSI to ensure are sealed sources, not all sealed sources the NRC is proposing to include three accumulation control for packages on a meet the definition of special form new paragraphs in §§ 71.22 and 71.23 conveyance. General license users material in 10 CFR 71.4. that are similar to the requirements in assign a CSI based on the equation in Removing the limitation to a Type A § 71.17(c), (d), and (e). The NRC is § 71.22(e)(1), and the fissile mass limits quantity of radioactive material in a proposing to add a new requirement in in either Table 71-1 or 71-2 to 10 CFR Type A package would allow licensees §§ 71.22(f) and 71.23(f) to ensure that, part 71. Table 71-2 contains mass limits to ship material under the general for shipments made using the respective for shipping uranium enriched to licenses in §§ 71.22 and 71.23 in a Type general license, each licensee must various weight percent levels in 235U.

B package. When shipping material that comply with § 71.17(c), i.e., the licensee However, § 71.22(e)(5) states in part that meets the mass limits of the general must: (1) maintain a copy of the NRC the lower mass values of Table 71-1 licenses in §§ 71.22 and 71.23 in a Type approval, including all referenced must be used if the enrichment level of B package, the criticality safety documents; (2) comply with the terms uranium is unknown, if the amount of conclusions associated with these mass and conditions of the NRC approval and plutonium exceeds one percent of the limits remain valid. In fact, the material the applicable requirements of subparts mass of 235 U, or if 233 U is present in the would be less likely to present a A, G, and H in 10 CFR part 71; and (3) package.

criticality hazard, as Type B packages prior to first use, register to use the While 233 U is not present in natural generally are more robust and have package. A licensee is only required to uranium, it may be present in very low more mass, which would increase register once to use a package, and concentrations in some facilities that neutron absorption, limit releases under therefore a licensee already registered to may have handled 233 U in the past.

hypothetical accident conditions, and use the package via § 71.17 would not These contamination-level prevent material from multiple packages have to re-register to use the package concentrations, while detectable with from redistributing together under under one of these two general licenses. modern isotopic assay methods and optimum moderation conditions. The NRC is proposing to add a new physically present, are not important Revising the general licenses to requirement in §§ 71.22(g) and 71.23(g) for criticality safety of 235 U authorize transport in a Type B package to state that, for a package to be used transportation. The calculations used to would also require conforming changes under the respective general license, the support the enrichment limit for to § 71.0(d)(1). The regulations in NRC package approval must state that § 71.15(d), for up to 1.0 weight percent

§ 71.0(d)(1) state that use of the general the package can be used under the enriched uranium, demonstrate that this licenses in § 71.22 or § 71.23 does not general license in either § 71.17 or the limit is safe provided the plutonium and general license in § 71.22 or § 71.23. 233 U are limited to less than one percent require NRC approval. Package approval Authorizing use under the general of the mass of 235 U. The same limitation is not currently required by the NRC license in § 71.17 would ensure that could be applied to the use of Table 71-because the conditions of the general existing, approved Type B package 2 limits for shipping enriched uranium licenses require the contents to be in a designs could also be used to transport under § 71.22, without affecting Type A package. The regulations in the material authorized by one of the criticality safety.

§ 71.14(b)(1) exempt the licensee from two general licenses in § 71.22 or The NRC is therefore proposing to all requirements in 10 CFR part 71, § 71.23. revise § 71.22 to limit the 233 U to less except for §§ 71.5 and 71.88, when Finally, the NRC is proposing to add than one percent of the mass of 235 U, shipping a Type A quantity. Because the a new requirement in §§ 71.22(h) and similar to the provision limiting NRC is proposing to revise §§ 71.22 and 71.23(h) to ensure that any Type B plutonium in § 71.22(e)(5)(ii).

71.23 to authorize shipment of a Type package used under the respective Issue 15. Other Recommended Changes B quantity of radioactive material, an general license approved by the NRC to 10 CFR Part 71 NRC package approval would be before the effective date of the final rule required for shipment of the Type B is subject to the transitional As described in the draft regulatory quantity of radioactive material. The arrangements in § 71.19. Issue 10 in basis, Issue 15 groups several topics NRC package approval for the Type B Section III of this document describes identified by the NRC, some of which quantity of radioactive material would the NRCs proposed changes to its are not directly related to harmonizing not include evaluation of criticality transitional arrangements. NRC requirements with IAEA standards, safety because the criticality safety is In summary, the NRC is proposing to and include clarifications to ensure assured for shipment of fissile material remove the restriction in §§ 71.22 and compatibility with the DOT and

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clarifications to Agreement State part 71, Appendix A, Tables A-1 and Issue 15.4. Revision to Agreement State regulations. A-2. Compatibility Categories Issue 15.1. Deletion of Duplicative To be considered radioactive material The NRC is proposing several changes Reporting Requirements under DOTs regulations (i.e., Class 7 to the compatibility category In the 2002 proposed rule (67 FR (radioactive) material as defined in 49 designations related to the QAP and 21390, April 30, 2002), the NRC CFR 173.403), the material must exceed reporting requirements. These changes proposed changes to its reporting both the nuclide specific exemption would ensure that Agreement States requirements in § 71.95, Reports. concentration limit and the have the appropriate authority to Those proposed changes would have: consignment exemption activity limit. approve, inspect, and enforce QAPs for (1) required licensees to obtain The A1 and A2 values are quantities of their licensees, as well as that the NRC certificate holder input before radioactivity that are used in the and Agreement States receive important submitting an event report; (2) provided transportation regulations to determine reports regarding issues with radioactive direction on the content of the written the type of packaging necessary for a material shipments.

report; and (3) lengthened the reporting particular radioactive material The NRC is proposing to revise the requirement date to 60 days, consistent shipment. Each radionuclide is assigned compatibility category designations for with other reporting requirements in an A1 and an A2 value, where A1 is the the regulations containing QAP NRC regulations. The proposed rule maximum activity of special form requirements for those Agreement States recommended adding 71.95(a)(1) and (2) material that is permitted in a Type A that have licensees located within their and 71.95(b), but not the current package, and A2 is the maximum States who use NRC-approved Type B 71.95(a)(3). activity of normal form radioactive packages, other than for industrial In the final rule (69 FR 3697, January material that is permitted in a Type A radiography, to ship Type B quantities 26, 2004), the NRC stated that the package as prescribed in 10 CFR 71.4 of radioactive material; or have proposed rule had inadvertently left out and 49 CFR 173.403. The NRCs and the licensees that ship using the general new paragraph (a)(3), mentioned in the DOTs transportation regulations license in § 71.21, General license: Use proposed rules regulatory analysis, that include package activity limits based on of foreign approved package; § 71.22, would retain the existing requirement fractions or multiples of the A1 and A2 General license: Fissile material; or for licensees to report instances of values (e.g., 10¥3A2 and 3,000A2, § 71.23, General license: Plutonium-failure to follow the conditions of the respectively). beryllium special form material. The CoC while a packaging was in use. In its concurrent harmonization NRC is also proposing to revise the Paragraph (a)(3) was thus added to the rulemaking, the DOT is proposing to compatibility category designation for final rule. However, in adding that make changes to 49 CFR 173.435, the reporting requirements in § 71.95.

paragraph to the final rule, the NRC Table of A1 and A2 values for In the 2004 final rule (69 FR 3697; introduced duplicative language radionuclides, and 173.436, Exempt January 26, 2004) that revised § 71.101, between it and paragraph (b). material activity concentrations and Quality assurance requirements, the The NRC is proposing to delete the exempt consignment activity limits for NRC stated that § 71.101(b), and (c)(1) duplicative text in paragraph (a)(3). radionuclides, by adding seven are designated as Compatibility radionuclides, including barium-135m, Category C for those Agreement States Issue 15.2. Revision of the Definition of germanium-69, iridium-193m, nickel-that have licensees that use Type B Low Specific Activity 57, strontium-83, terbium-149, and packages, other than for industrial The NRC is proposing to modify the terbium-161. The NRC is proposing to radiography. For Compatibility Category first sentence in the definition of Low make corresponding changes to Tables C, the essential objectives of the NRC Specific Activity (LSA) material in A-1 and A-2 to add these program elements should be adopted by

§ 71.4 to change excepted under radionuclides. The NRC is proposing to such Agreement States. The NRC is

§ 71.15 to exempted under § 71.15. revise the specific activity of natural proposing to change the compatibility This change would make the definition rubidium (Rb(nat)) to correct an error category designation for 71.101(b) and of LSA in § 71.4 consistent with the title that was introduced in the 1995 version (c)(1) from C to B. This is consistent of § 71.15, Exemption from of the rule. Table A-1 of Appendix A to with Management Directive 5.9, classification as fissile material and 10 CFR part 71 gives the specific Adequacy and Compatibility of ensure that it is clear that LSA packages activity as 6.7 x 106 TBq/g, 1.8 x 108 Ci/ Program Elements for Agreement State may contain fissile material up to the g. However, the correct value for the Programs, which states that program exemption limits in § 71.15. specific activity of Rb(nat) is 670 Bq/g elements in Compatibility Category B Issue 15.3. Revision of Tables (6.7 x 10¥10 TBq/g, 1.8 x 10¥8 Ci/g). are those that apply to activities that Containing A1 and A2 Values and The A1 and A2 values were not cross jurisdictional boundaries. Since Exempt Material Activity and impacted by this error and remain the QAP activities in 71.101(b) and Consignment Limits correct. The NRC is also proposing to (c)(1) are used during domestic shipping revise footnote c at the end of Table A-of radioactive material and therefore The IAEA has made changes in SSR-2 to state that in the case of thorium-cross jurisdictional boundaries, a B 6, 2018 Edition, related to the A1 and A2 natural, the parent radionuclide is compatibility would align with activity values and the exempt material thorium-232, and in the case of Management Directive 5.9 criteria. Also, activity concentrations and exempt uranium-natural, the parent many of the regulations that contain consignment activity limits. The DOT is radionuclide is uranium-238. Further, QAP review criteria (e.g., §§ 71.109, the lead agency for information related the NRC is proposing to editorially 71.111, 71.113, 71.115, 71.117, 71.119, to the A1 and A2 values and for the revise several other radionuclides to 71.121, 71.123, and 71.125) were exempt material activity concentrations move the name of the element and its addressed in the 2004 rule, but were and exempt consignment activity limits, atomic number (shown in the second designated as Compatibility Category as provided in 49 CFR 173.435 and column of each table) to the first NRC, which relate to areas of regulation 173.436, respectively. The NRC has instance of that element alphabetically reserved to the NRC that cannot be corresponding information in 10 CFR in the tables. adopted by the Agreement States. The

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NRC is proposing to address these situation. The NRC also is proposing to greater than 1 Gy (100 rad) per hour at compatibility issues in this proposed update the compatibility category for a distance of 1 meter (3.3 feet) from any rule so that, consistent with the intent § 71.95(b) to Compatibility Category C to accessible surface without intervening of the 2004 rulemaking, Agreement ensure that the Agreement State agency shielding. Licensees are also required to States can adopt compatible QAP receives these reports from its licensees provide notification of such shipments regulations that would require their indicating instances when the CoC was to the NRC in accordance with § 73.72.

licensees to follow these QAP criteria not followed. As noted in the 1995 final Additionally, as required in § 73.35, and allow Agreement States to approve, rule (60 FR 50248, 50259), the purpose Requirements for physical protection inspect and enforce their licensees of this requirement is to provide of irradiated reactor fuel (100 grams or QAPs. Specifically, this rule proposes to feedback on QAP effectiveness. less) in transit, licensees who transport correct the compatibility category Consistent with the compatibility 100 grams or less of irradiated reactor designation to B for many of these category corrections for other QAP fuel, when the external radiation dose regulations that are currently related regulations, this proposed rule rate is greater than 1 Gy (100 rad) per Compatibility Category NRC, C, or D. would also correct the compatibility hour at a distance of 1 meter (3.3 feet)

This change would require Agreement category for § 71.95(b) so that from any accessible surface without States to have essentially identical Agreement States receive these QAP-intervening shielding, are required to regulations and would give the related reports. The compatibility provide advance notification of Agreement States the authority to categories for § 71.95(c) and (d) would shipment in accordance with § 37.77.

approve, inspect and enforce their also be revised to Compatibility When 10 CFR part 37 was established in licensees QAPs. Only Agreement States Category C so that these reports contain 2013, this requirement was introduced, with licensees that use Type B packages, the required information. but the irradiated reactor fuel aspect other than for industrial radiography, or In summary, the NRC is proposing to was not removed from § 71.97.

with licensees that ship using the revise the compatibility category for (1) Therefore, licensees may need to general license in § 71.21, § 71.22, or § 71.101(b) and (c)(1) from a produce two reports for a single

§ 71.23, which also requires an Compatibility Category C to B to be in shipment to meet the advance approved QAP, would be impacted. alignment with the criteria in notification requirements of §§ 71.97 Additionally, the regulations in Management Directive 5.9; (2) many of and 73.37 or § 73.35. To address this

§ 71.95 require NRC licensees to submit the QAP-related regulations (e.g., potential inefficiency the NRC is a written report to the NRC of instances §§ 71.109, 71.111, 71.113, 71.115, proposing to modify § 71.97 to remove in which there is a significant reduction 71.117, 71.119, 71.121, 71.123, and references to irradiated reactor fuel.

in the effectiveness of any NRC-71.125) from a Compatibility Category IV. Specific Request for Comment approved package; details of defects NRC, C, or D to a B to allow the with safety significance in any NRC-Agreement States the authority to The NRC is seeking comment and approved package, after first use; and approve, inspect and enforce these feedback from the public on this instances in which the conditions of a regulations; and (3) the reporting proposed rule. The NRC is particularly CoC were not followed during requirements in § 71.95(a) and (b) from interested in comment and supporting shipment. In the 2004 final rule (69 FR a Compatibility Category D to C so that rationale from the public on the 3697; January 26, 2004) that revised the NRC receives reports from following:

§ 71.95, the NRC stated that the Agreement State licensees on package QUESTION 1: IAEA Changes in SSR-6 compatibility category for § 71.95 is defects pursuant to § 71.95(a), and that (2018 Edition) Not in the Scope of This Category D; therefore, it does not need Agreement State regulators receive Proposed Rule to be adopted by the Agreement States reports when their licensees do not use Starting in 2016, while developing the to be compatible with the NRCs an NRC-approved package in regulatory basis for this proposed rule, regulatory program. The reporting accordance with the CoC pursuant to the NRC considered the changes in requirements in § 71.95(a) are to ensure § 71.95(b), and to § 71.95(c) and (d) so SSR-6, 2012 Edition, and the proposed that the NRC is alerted to instances in that these reports contain the required changes that were being considered for which a package may have a defect or information. SSR-6, 2018 Edition, which were has a significant reduction in Issue 15.5. Deletion of Redundant eventually issued in June 2018. The effectiveness such that, as needed, other Advance Notification Requirements for NRC contracted with Oak Ridge licensees authorized to use the package Shipment of Spent Nuclear Fuel National Laboratory (ORNL) to develop are made aware of the possible issues. Section 71.97 is titled Advance ORNL/TM-2014/658, Comparison of Agreement State licensees also use NRC-notification of shipment of irradiated the International and United States approved packages, including industrial reactor fuel and nuclear waste. Domestic Radioactive Material radiography devices, but are not subject However, advance notification Transport Regulations. In this to any of the requirements in § 71.95 requirements for irradiated reactor fuel document, ORNL compared both NRC and, therefore, are not required to (and, equivalently, spent nuclear fuel) and DOT regulations to SSR-6, 2012 submit a report to the NRC pursuant to are separately included in the more Edition, and noted the differences. The

§ 71.95. The NRC is proposing to change general requirements of 10 CFR part 73, NRC then compared the changes the compatibility category for § 71.95(a) Physical protection of plants and between SSR-6, 2018 Edition, and the to Compatibility Category C in order to materials. Specifically, as required in 2012 Edition to determine which have Agreement State regulations § 73.37(b)(2), licensees are required to changes affect NRC regulations and require notification to the NRC of these provide advance notification of whether those changes should be instances. This will clarify that if a State shipment to the Governor of a State and/ included in this proposed rule. Based licensee uses an NRC-approved package or Tribal official for any shipment on this review, the NRC did not include that has a defect or has a significant crossing the State or Tribal boundary the following IAEA changes in the scope reduction in effectiveness the NRC is when the shipment contains greater of this proposed rule:

aware such that others using the than 100 grams irradiated reactor fuel 1. Issue 1 consisted of four different package can be made aware of the and the external radiation dose rate is sub-issues: Issue No. 1a: New Fissile

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Exceptions in IAEA SSR-6, paragraph limits, and a formula for determination approved to Type C standards.

417; Issue No. 1b: Competent Authority-of a lower CSI, for packages which Therefore, the NRC is not proposing to Approved Fissile Exception, SSR-6, withstand normal conditions of add Type C package standards in this paragraph 417(f); Issue No. 1c: CSI-transport while maintaining a larger proposed rule.

Controlled Fissile Material Packages, minimum external dimension of 30 4. Testing and reporting the integrity SSR-6, paragraph 674; and Issue No. 1d: centimeters. The IAEA SSR-6, of the containment system and Plutonium Shipments in Type A paragraph 674(c), contains the same CSI shielding, and assessing criticality Packages, SSR-6, paragraph 675. calculation as paragraph 674(b), for safety (paragraph 716), and additional For issue 1a, the NRC considered packages that withstand normal description of the impact of the tests on whether to adopt the fissile exceptions conditions of transport while packages (paragraphs 718-737)The in paragraphs 417(c), without maintaining a minimum external NRC reviewed its regulations for an consignment limits in paragraph 570(c); dimension of 10 centimeters, with a application for approval of a package the consignment limit in paragraph limit of 15 grams fissile material per design and considered its regulations 570(d) associated with the package mass package. sufficient to obtain the information limit in paragraph 417(d); and the The NRC does not propose to adopt needed to determine whether a package exception in paragraph 417(e) and its the changes in IAEA SSR-6, paragraph design meets the requirements in 10 associated exclusive use restriction in 674, because the NRC has determined CFR part 71.

paragraph 570(e), but with a mass limit that the mass limits and other 5. Addition of LSA Fissile Shipments of 140 g instead of the IAEA mass limit requirements in §§ 71.22 and 71.23 are (paragraphs 518, 519, 520)Since LSA of 45 grams of fissile material from SSR-appropriate for providing criticality packages are self-certified under DOT 6, 2018 Edition, into the NRC safety equivalent to packages approved regulations, other than the fissile regulations. The NRC chose not to adopt under the criticality safety requirements material exemptions (§ 71.15) and fissile the consignment limits in 570(c) and (d) of §§ 71.55 and 71.59. Adopting the material general licenses (§§ 71.22 and for the fissile exceptions in 417(c) and provisions of IAEA SSR-6 would result 71.23), there is no mechanism for 417(d), respectively because in more restrictive mass limits for the adding fissile material to an LSA consignment limits do not prevent the fissile material general licenses package without NRC approval. Under accumulation of packages on a transport authorized under 10 CFR part 71. current NRC regulations, the package conveyance, as there is no limit to the The NRC evaluated issue 1d, SSR-6, could be certified but would become a number of consignments that may be paragraph 675, to add NRC Type BF or Type AF package, present on a single conveyance. requirements for shipment of plutonium depending on the quantity of Additionally, the accumulation on a in a nonfissile package, with radioactive material in the package, and single conveyance of the number of accumulation control provided by the therefore the NRC did not consider any these packages required to approach calculation of a CSI. This provision was revision necessary.

criticality is not credible. included in SSR-6, 2012 Edition but 6. Safety Factors for Lifting After evaluation of Issue 1b, the NRC without accumulation control. The Attachments (paragraph 608)The NRC is not proposing to add the new NRCs fissile exemption in § 71.15(f) is regulations in § 71.45 contain competent authority-approved fissile similar in that it limits the package to quantitative criteria for evaluating exception in paragraph 417(f) into the 1000 g of plutonium, of which not more lifting attachments that are considered a NRC regulations. If an NRC licensee than 20 percent by mass may be structural part of the package. The IAEA wished to ship a material that did not plutonium-239, plutonium-241, or any standards state an appropriate safety meet the fissile material exemption or combination of the two; however, the factor must be used. In its review, the general license criteria in 10 CFR part NRC regulation does not include NRC determined that adopting the IAEA 71, and for which demonstration of accumulation control via a CSI changes would not result in safety subcriticality in a package per the calculation. The NRC has determined benefits beyond those in § 71.45.

requirements of §§ 71.55 and 71.59 is that the fissile exemption in § 71.15(f) is 7. Shipment after Storage and Gap deemed too burdensome, the licensee safe without accumulation control, and Analysis (paragraphs 503(e) and could request a specific exemption that there is no safety benefit to limiting 809(k))The IAEA added regulations under § 71.12. The NRC notes that if an accumulation through the use of a CSI, both for shipment after storage and a NRC licensee submitted a competent in order to be consistent with the IAEA gap analysis for packages in storage authority-approved exception, the standards. Therefore, the NRC is not prior to shipment. The regulations in approval would include both NRC and proposing to harmonize with paragraph SSR-6, paragraph 503(e), require that DOT reviews and issuance of the 675, SSR-6, 2018 Edition. during storage, packages are maintained exception and the NRC review and 2. The NRC considered adopting the to ensure that all relevant transportation findings would be similar to those of reduced external pressure value of 60 standards in SSR-6 and certificates of either an exemption or NRC-issued CoC. kPa from paragraph 645 and the air approval for those packages will be After evaluation of Issue 1c, the NRC transport package requirements from fulfilled. The NRC is not proposing to is not proposing to add CSI-controlled paragraph 621. The NRC is not adopt paragraph 503(e) because, during fissile material packages that the IAEA proposing to harmonize with paragraphs its review of packages for which storage incorporated into SSR-6, paragraph 674. 621 and 645, SSR-6, 2018 Edition, as is expected prior to transport (i.e., dual The IAEA SSR-6, paragraph 674(a), discussed for Issue 2 in Section III of purpose casks or canisters), the NRC contains fissile material mass limits (per this proposed rule, to avoid creating ensures that the evaluations, operating Table 13 in SSR-6, paragraph 674) and unnecessary mode-specific restrictions procedures, maintenance program and a CSI determination for packages with a within 10 CFR part 71. acceptance tests for transport take minimum external dimension of 10 3. Inclusion of Type C Package storage into consideration. In addition, centimeters, which are not required to Standards (paragraphs 669-672)The for any package that is stored prior to withstand normal conditions of NRC considered adding Type C package transport, existing NRC requirements transport in SSR-6, paragraphs 719-standards for domestic transport, but (§§ 71.17(c) and 71.87(b)) ensure that, 724. The IAEA SSR-6, paragraph 674(b), there was not an expressed need for prior to transport, the licensee must contains similar fissile material mass domestic transport of packages comply with the terms and conditions

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of the NRC approval for the package The Secretary of Transportation has chapter I to information in appendix A design and ensure the package is in the authority to regulate the to 10 CFR part 71 and replace those unimpaired physical condition. transportation of hazardous materials with references to the appropriate Following the operating procedure, per the Hazardous Materials regulation in 49 CFR chapter I.

maintenance program, and acceptance Transportation Act, as amended and

• Please comment on whether the tests in the application is a condition of codified in 49 U.S.C. 5101, et seq. The NRC should consider removing Tables approval in all NRC-approved CoCs. Secretary is authorized to issue A-1 through A-4 in appendix A to 10 The NRC is not proposing to adopt regulations to implement the CFR part 71 and instead refer to the paragraph 809(k), which requires requirements of the statute. The DOTs appropriate DOT tables in 49 CFR periodic evaluation of changes of Pipeline and Hazardous Materials Safety chapter I, rather than updating Tables regulations, changes in technical Administration has been delegated the A-1 through A-4 in appendix A to 10 knowledge and changes of the state of responsibility for the hazardous CFR part 71 as currently shown in this the package design during storage. The materials regulations, which are proposed rule. If so, would there be a NRCs transitional arrangements contained in 49 CFR parts 100-185. benefit to members of the public, authorize continued use of package These regulations include the including applicants and licensees?

designs approved to prior versions of requirements for Class 7 (radioactive) Please explain your rationale.

the NRC regulations, with limitations on material. QUESTION 3: Merits of Requiring a fabrication and restrictions on The DOT maintains the same Biennial Report for No Changes to a modifications to package designs information in 49 CFR 173.433 through QAP without the need to demonstrate full 49 CFR 173.436 as found in the NRCs compliance with the revised appendix A to 10 CFR part 71. With the As described in Section III of this regulations. Package designs compliant authority to regulate the transportation document, in Issue 12, the NRC is with the existing regulations do not of hazardous materials, including Class proposing to revise § 71.106 to achieve become unsafe when the regulations 7 (radioactive) material, DOT is the lead NRCs stated intent in the 2015 final are revised (unless a significant safety agency for determining the basic rule. Specifically, the NRC is proposing issue is corrected in the revision). If a radionuclide values (A1 and A2 values) to revise § 71.106(b) to clarify that a significant safety issue is corrected in a and the exempt material activity biennial report must be submitted to the rulemaking, NRC certificate holders for concentrations and exempt consignment NRC even if no changes are made to the that package design or type of package activity limits for radionuclides that are QAP during the reporting period. This would be informed via generic used in radioactive material proposed requirement would benefit the communication (e.g., regulatory transportation activities. The DOT NRCs regulatory oversight of QAP information summary, bulletin, or regulations include: approval holders. The NRC inspection generic letter), and as appropriate, 49 CFR 173.433, Requirements for program for 10 CFR part 71 QAP required to take action, prior to a determining basic radionuclide approval holders relies on having potential rule change. In addition, as values, and for the listing of current information about the QAP stated previously, prior to transport the radionuclides on shipping papers and available to the NRC, including the licensee must comply with the terms labels reporting of no changes. The 24-month and conditions in the NRC approval and 49 CFR 173.433, Table 7, General reporting period aims to provide an ensure the package is in unimpaired Values for A1 and A2 appropriate balance between the burden physical condition. 49 CFR 173.433, Table 8, General placed on the QAP approval holders

• Is there anything in SSR-6, 2018 Exemption Values and the need to ensure that the NRC has Edition, that the NRC did not include in 49 CFR 173.434, Activity-mass current information, especially when the scope of this proposed rule, but relationships for uranium and natural considering most QAP approval holders should have? In your comment, please thorium subject to periodic inspection are explain why the NRC should consider 49 CFR 173.435, Table of A 1 and A2 inspected every 5 years or on an as-adding the change to the final rule and values for radionuclides needed basis. Another benefit is that the the associated benefits. 49 CFR 173.436, Exempt material revised QAP reporting requirements in QUESTION 2: Removing Tables A-1 activity concentrations and exempt 10 CFR part 71 would be consistent Through A-4 in Appendix A to 10 CFR consignment activity limits for with those in 10 CFR 50.54(a)(3) and Part 71 radionuclides 50.71(e)(2) for 10 CFR part 50 QAPs.

The NRC transportation regulations in The NRC recognizes challenges The benefits and costs of the proposed 10 CFR part 71 include appendix A to associated with maintaining the requirement are described in the 10 CFR part 71, Determination of A1 accuracy and consistency of all the regulatory analysis and the NRC and A2. The introductory material in information in appendix A to 10 CFR estimates that the cost of compliance is paragraphs I-V to appendix A includes part 71 with the parallel information in very small. The NRC is interested in the information related to determining A1 49 CFR chapter I, considering, in part, publics feedback as to the benefits and and A2 values. Appendix A includes the periodic updates the DOT makes to costs of requiring a no-change biennial four tables: these regulations to harmonize with report.

Table A-1: A 1 and A2 Values for IAEA standards. Therefore, to minimize

• Please comment on the benefits and Radionuclides duplicative information within the costs of requiring a 10 CFR part 71 QAP Table A-2: Exempt Material Activity domestic transportation regulations, and approval holder to submit a biennial Concentrations and Exempt to recognize the DOTs authority to report to the NRC even if no changes are Consignment Activity Limits for regulate Class 7 (radioactive) material, made to the QAP during the reporting Radionuclides the NRC is considering removing the period.

Table A-3: General Values for A 1 content of appendix A to 10 CFR part V. Section-by-Section Analysis and A2 71. Where it is necessary within the Table A-4: Activity-Mass subparts of 10 CFR part 71, the NRC The following paragraphs describe the Relationships for Uranium would remove all references in 10 CFR specific changes in this proposed rule.

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Section 7

1.0 Purpose and Scope

respective general license and that any Section 71.73 Hypothetical Accident This proposed rule would revise Type B package used under the Conditions paragraph (d)(1) to clarify general respective general license approved by This proposed rule would revise license package approval requirements. the NRC before the effective date of the paragraph (b) to add insolation to the Section 71.4 Definitions final rule is subject to the transitional initial conditions for the tests for arrangements in § 71.19. hypothetical accident conditions.

This proposed rule would revise the Section 71.23 General License:

definitions for Low Specific Activity Plutonium-Beryllium Special Form Section 71.77 Qualification of LSAIII material, Special form radioactive Material Material material, and Surface Contaminated Object, delete the definition for Low This proposed rule would revise This proposed rule would remove and Specific ActivityIII Leaching Test, and paragraphs (a) and (c), and add reserve § 71.77 and make conforming add a new definition for Radiation level. paragraphs (f) through (h) to clarify that changes to §§ 71.4 and 71.100.

Section 71.15 Exemption From only special form sealed sources, not Section 71.95 Reports Classification as Fissile Material just sealed sources may be delivered to This proposed rule would revise the a carrier for transport using the general This proposed rule would remove introductory paragraph by replacing (f) license in § 71.23. paragraph (a)(3) as it is duplicative to with (g), paragraph (a) by adding new Section 71.31 Contents of Application text in paragraph (b).

subparagraphs (1) and (2), paragraph (d) This proposed rule would revise Section 71.97 Advance Notification of by replacing of up to with not paragraph (a) to add a maintenance Shipment of Irradiated Reactor Fuel and exceeding, and add paragraph (g), which program description, as required by Nuclear Waste is a new provision for exclusive use of § 71.35 among the contents of This proposed rule would revise the transportation packages. application. section title, the introductory text of Section 71.17 Exemption From Section 71.35 Package Evaluation paragraph (b), and paragraphs (d) and Classification as Fissile Material (f)(1) to remove references to irradiated This proposed rule would revise This proposed rule would revise reactor fuel to correct a duplicative paragraph (e) to change the design paragraph (b) to delete and paragraph advance notification reporting approval date for Type B or fissile (c) to add ; and and add new requirement in § 71.97 with those in material packages from April 1, 1996, to paragraph (d) to specify maintenance §§ 73.35 and 73.37.

the effective date of the final rule. program requirements. Section 71.100 Criminal Penalties Section 71.19 Previously Approved Section 71.43 General Standards for Package All Packages This proposed rule would revise This proposed rule would revise This proposed rule would revise paragraph (b) to remove the leaching paragraph (a) to include existing CoCs paragraph (d) to specifically include the test requirement as a conforming change that have a -96 in their package evaluation of the effects of aging, and to to § 71.77.

identification number, redesignate specify that degradation evaluations Section 71.106 Changes to Quality paragraphs (c) and (d) as paragraphs (d) will be managed by the maintenance Assurance Program and (e), revise newly redesignated program in accordance with § 71.35(d), This proposed rule would revise the paragraph (e) to include those CoCs that and add new paragraph (i) to specify introductory text of paragraph (b) to have a suffix -96 in their that each system designed to contain clarify that a biennial report must be identification numbers, and add new liquids has adequate ullage during submitted to the NRC even if no changes paragraph (c), to add transitional evaluation of the tests and conditions are made to the QAP during the arrangements on existing CoCs that have for normal conditions of transport and reporting period.

a -96 in their package identification hypothetical accident conditions number. specified in §§ 71.71 and 71.73. Appendix A to Part 71Determination Section 71.22 General License: Fissile Section 71.55 General Requirements of A1 and A2 Material for Fissile Material Packages This proposed rule would revise This proposed rule would revise This proposed rule would revise Tables A-1 and A-2 in paragraph V.b.

paragraph (a) to replace subparts E and paragraph (g)(1) to require that there is to add seven radionuclides and correct F of this part with §§ 71.55 and no contact between the cylinder plug the specific activity of natural rubidium.

71.59 and to remove the limitation to and any other part of the packaging, VI. Regulatory Flexibility Certification a Type A quantity of radioactive other than at its original attachment material in a Type A package to allow point and that the cylinder plug remains Under the Regulatory Flexibility Act shipment of material under the general leak tight, as NRC requires for the (5 U.S.C. 605(b)), the NRC certifies that licenses in §§ 71.22 and 71.23 in a Type cylinder valve. this proposed rule will not, if issued, B package, paragraph (c) to remove Section 71.71 Normal Conditions of have a significant economic impact on (c)(1) and redesignate paragraph (c)(2) as Transport a substantial number of small entities.

new paragraph (c), paragraphs (e)(3) This proposed rule affects a number of through (5) to limit the 233U to less than This proposed rule would change the small entities as defined by the one percent of the mass of 235U, similar unit of measure in the table in Regulatory Flexibility Act or the size to the provision limiting plutonium in paragraph (c)(1) to change the unit of standards established by the NRC

§ 71.22(e)(5)(ii), and add new measure for the values of insolation (§ 2.810). However, as indicated in the paragraphs (f) through (h) to ensure that used for the heat test for normal regulatory analysis, these amendments each licensee will comply with conditions of transport from (g cal/ do not have a significant economic

§ 71.17(c) for shipments made using the cm2) to (W/m2). impact on the affected small entities.

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VII. Regulatory Analysis regulation (CER). The CER describes the amended, and the Commissions The NRC has prepared a regulatory challenges that licensees, or other regulations in subpart A of 10 CFR part analysis on this proposed rule. The impacted entities such as State partners, 51, that this rule, if adopted, would not analysis examines the costs and benefits may face while implementing new be a major Federal action significantly of the alternatives considered by the regulatory positions, programs, or affecting the quality of the human NRC and includes consideration of the requirements (e.g., rules, generic letters, environment, and an environmental costs and benefits of updating guidance. backfits, inspections). The CER is an impact statement is not required. The The NRC requests public comment on organizational effectiveness challenge basis of this determination is as follows:

the regulatory analysis. The regulatory that may result from a licensee or The amendments would change the analysis is available as indicated in the impacted entity implementing a number requirements for packaging and Availability of Documents section of of complex regulatory actions, transportation of radioactive material.

this document. Comments on the programs, or requirements within The amendments would make changes regulatory analysis may be submitted to limited available resources. to harmonize the NRCs regulations with the NRC as indicated under the To better understand the potential the 2018 Edition of the IAEAs transport ADDRESSES section of this document. CER implications incurred due to this standards (SSR-6) and with that of the proposed rule, the NRC is requesting DOTs regulations under 49 CFR and VIII. Backfitting and Issue Finality comment on the following questions. include NRC-initiated changes. The The NRC has determined that Responding to these questions is environmental impacts arising from the backfitting (§ 50.109, § 70.76, § 72.62, or voluntary, and the NRC will respond to changes have been evaluated and would

§ 76.76) and the issue finality provisions any comments received in the final rule. not involve any significant in 10 CFR part 52 do not apply to this 1. In light of any current or projected environmental impact. This includes proposed rule because it would not CER challenges, does the proposed consideration of direct, indirect, and involve any provisions that would rules effective date provide sufficient cumulative impacts. Other amendments impose backfits as defined in 10 CFR time to implement the new proposed are procedural in nature and would chapter I or affect the issue finality of requirements, including changes to have no significant impact on the any approval issued under 10 CFR part programs and procedures? environment.

52. Some licensees that are within the 2. If current or projected CER The preliminary determination of this scope of the backfit rule (e.g., a power challenges exist, what should be done to environmental assessment is that there reactor or a fuel fabrication facility) address this situation? For example, if will be no significant effect on the transport radioactive material from their more time is required for quality of the human environment from own facilities. Those backfitting and implementation of the new this action. Public stakeholders should issue finality provisions apply to requirements, what period of time is note, however, that comments on any activities directly regulated under those sufficient? aspect of this environmental assessment parts, and do not apply to activities 3. Do other regulatory actions (from may be submitted to the NRC as regulated under other parts that do not the NRC or other agency) influence the indicated under the ADDRESSES caption.

include backfitting or issue finality implementation of the proposed rules The environmental assessment is provisions. The exception to this requirements? available as indicated under the general principle is where the activity 4. Are there unintended Availability of Documents section of regulated under other parts that do not consequences? Does the proposed rule this document.

include backfitting or issue finality create conditions that would be contrary The NRC has sent a copy of the provisions is an inextricable part of the to the proposed rules purpose and environmental assessment and this regulated activity within the scope of objectives? If so, what are the proposed rule to every State Liaison backfitting or issue finality. Preparing unintended consequences, and how Officer and has requested comments.

packages for transport is not an should they be addressed? XII. Paperwork Reduction Act inextricable part of the procedures or 5. Please comment on the NRCs cost organization required to design, and benefit estimates in the regulatory This proposed rule contains new or construct or operate a facility as analysis that supports this proposed amended information collection licensed under 10 CFR part 50, 52, 70, rule. requirements that are subject to the 72, or 76; rather, it is a separate activity X. Plain Writing Paperwork Reduction Act of 1995 (44 that these licensees may choose to The Plain Writing Act of 2010 (Pub. U.S.C. 3501 et seq.). This proposed rule undertake. The scope of this proposed L. 111-274) requires Federal agencies to has been submitted to the Office of rule does not include any changes to write documents in a clear, concise, and Management and Budget (OMB) for any of those facilities or plants well-organized manner. The NRC has review and approval of the information activities for which the backfit rule written this document to be consistent collection requirements.

applies. Type of submission, new or revision:

with the Plain Writing Act as well as the Revision.

The NRCs determination on this Presidential Memorandum, Plain The title of the information collection:

matter is in accordance with Language in Government Writing, Harmonization of Transportation Safety Management Directive 8.4, published June 10, 1998 (63 FR 31885). Requirements with IAEA Standards.

Management of Backfitting, Forward The NRC requests comment on this The form number if applicable: Not Fitting, Issue Finality, and Information document with respect to the clarity and applicable.

Requests, and its associated guidance effectiveness of the language used. How often the collection is required:

in NUREG-1409, Backfitting XI. Environmental Assessment and Applications for changes reducing Guidelines. Proposed Finding of No Significant commitments to the NRC on quality IX. Cumulative Effects of Regulation Environmental Impact assurance programs and for package approval are submitted on occasion.

The NRC seeks to minimize any The Commission has preliminarily Quality assurance program reporting on potential negative consequences determined under the National changes determined not to reduce resulting from the cumulative effects of Environmental Policy Act of 1969, as commitments, or reporting of no

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changes made, is done every 24 months. searching on https:// would be removed from that paragraph Reporting packaging issues or instances www.regulations.gov under Docket ID as the leaching test would no longer be in which the conditions in a CoC are not NRC-2016-0179. required.

followed occur infrequently. You may submit comments on any XIV. Coordination With NRC Who will be required or asked to aspect of these proposed information Agreement States report: General or specific licensees who collection(s), including suggestions for The NRC has coordinated with the use a package, certificate holders and reducing the burden and on the above Agreement States throughout the applicants for a new or amended CoC. issues, by the following methods: development of this proposed rule.

An estimate of the number of annual

• Federal Rulemaking Website: Go to responses: 7.5. https://www.regulations.gov and search Agreement State representatives have The estimated number of annual for Docket ID NRC-2016-0179. served on the rulemaking working group respondents: 6.5.

• Mail comments to: FOIA, Library, that developed this proposed rule and An estimate of the total number of and Information Collections Branch T6-on the Standing Committee on hours needed annually to complete the A10M, U.S. Nuclear Regulatory Compatibility for the rulemaking. The requirement or request: 1,376.7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br /> Commission, Washington, DC 20555-NRC also provided a preliminary draft (an increase of 1,052.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> reporting 0001, or by email to of the proposed rule to the Agreement

+ an increase of 322.7 third party Infocollects.Resource@nrc.gov. States for review.

disclosure hours and 1.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />

• Submit to OMB Directly: Written XV. Compatibility of Agreement State recordkeeping). comments and recommendations for the Regulations Abstract: The NRC, in consultation proposed information collection should Under the Agreement State Program with the DOT, is proposing to amend its be sent within 60 days of publication of Policy Statement approved by the regulations for the packaging and this document to https:// Commission on October 2, 2017 and transportation of radioactive material. www.reginfo.gov/public/do/PRAMain. published in the Federal Register on The Commission has historically been Find this particular information October 18, 2017 (82 FR 48535), NRC consistent in its support of harmonizing collection by selecting Currently Under program elements (including the NRC transportation regulations with ReviewOpen for Public Comments or regulations) are placed into the IAEAs standards. These by using the search function. compatibility categories A, B, C, D, amendments would make the NRC Comments on the information NRC, or adequacy category Health and regulations conform to the recent collections will be publicly available in Safety (H&S). Compatibility Category A revisions to the IAEA standards for the ADAMS and on Reginfo.gov. Submit program elements are those program international transportation of comments by November 14, 2022. elements that are basic radiation radioactive material and maintain Comments received after this date will protection standards and scientific consistency with the DOT regulations. be considered if it is practical to do so, terms and definitions that are necessary These changes are necessary to maintain but the NRC is able to ensure to understand radiation protection a consistent regulatory framework for consideration only for comments concepts. An Agreement State should the packaging and transportation of received on or before this date. adopt Category A program elements in radioactive material. The NRC is also Public Protection Notification an essentially identical manner in order proposing to amend these regulations to The NRC may not conduct or sponsor, to provide uniformity in the regulation include administrative, editorial, or and a person is not required to respond of agreement material on a nationwide clarifying changes, including changes to to, a request for information or an basis. Compatibility Category B program certain Agreement State compatibility information collection requirement elements are those program elements category designations. unless the requesting document that apply to activities that have direct The NRC is seeking public comment and significant effects in multiple on the potential impact of the displays a currently valid OMB control jurisdictions. An Agreement State information collections contained in number. should adopt Category B program this proposed rule and on the following XIII. Criminal Penalties elements in an essentially identical issues: For the purposes of Section 223 of the manner. Compatibility Category C

1. Is the proposed information Atomic Energy Act of 1954, as amended program elements are those program collection necessary for the proper (AEA), the NRC is issuing this proposed elements that do not meet the criteria of performance of the functions of the rule that would amend 10 CFR part 71 Category A or B but do contain the NRC, including whether the information under one or more of Sections 161b, essential objectives that an Agreement will have practical utility? 161i, or 161o of the AEA. Willful State should adopt to avoid conflict,

2. Is the estimate of burden of the violations of the rule would be subject duplication, gaps, or other conditions proposed information collection to criminal enforcement. With the that would jeopardize an orderly pattern accurate? following exception, none of the in the regulation of agreement material

3. Is there a way to enhance the on a national basis. An Agreement State quality, utility, and clarity of the proposed amendments would change information to be collected? the manner in which criminal penalties should adopt the essential objectives of

4. How can the burden of the would be assessed or enforced. the Category C program elements.

proposed information collection on Criminal penalties as they apply to Compatibility Category D program respondents be minimized, including regulations in 10 CFR part 71 are elements are those program elements the use of automated collection discussed in § 71.100. One of the actions that do not meet any of the criteria of techniques or other forms of information within the scope of this rulemaking, Category A, B, or C and, therefore, do technology? Issue 6, Deletion of the Low Specific not need to be adopted by Agreement A copy of the OMB clearance package ActivityIII Leaching Test, proposes to States for purposes of compatibility.

is available in ADAMS under Accession remove the content of § 71.77 and Compatibility Category NRC program No. ML20101F920. You may obtain replace the section heading with elements are those program elements information and comment submissions RESERVED. This change would that address areas of regulation that related to the OMB clearance package by impact § 71.100(b), because § 71.77 cannot be relinquished to the

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Agreement States under the Atomic Compatibility Category NRC and cannot Category B. This re-designation would Energy Act of 1954, as amended, or be adopted by the Agreement States. require those Agreement States with provisions of title 10 of the Code of Since a proper QAP review cannot be applicable licensees to have essentially Federal Regulations. These program completed without addressing many of identical regulations. For those elements should not be adopted by the these criteria, Agreement States would Agreement States that do not have Agreement States. Adequacy category need to adopt compatible regulations to applicable licensees, these regulations H&S program elements are program require licensees that use NRC-approved will remain designated as Compatibility elements that are required because of a Type B packages for shipping, other Category D and, hence, do not have to particular health and safety role in the than for industrial radiography, or that be adopted for purposes of regulation of agreement material within ship using the general license in § 71.21, compatibility.

the State and should be adopted in a § 71.22 or § 71.23, to follow these QAP The changes in this proposed rule, manner that embodies the essential criteria. Additionally, since only a few discussed in Section III of this objectives of the NRC program. A Agreement States have applicable document, would be a matter of bracketed compatibility category (e.g., licensees that perform shipments of compatibility between the NRC and the

[B]) means that the provision may have Type B quantities of radioactive Agreement States, thereby providing been adopted elsewhere in the materials, other than for industrial consistency among Agreement State and Agreement States regulations and does radiography operations (which are NRC requirements. Regulations that are not need to be adopted again. covered under § 34.31), or that ship a part of this rulemaking but remain the As discussed in Section III of this using the general license in § 71.21, document, Issue 15.4, the regulations § 71.22, or § 71.23, all QAP-related same compatibility category designation that contain QAP requirements (e.g., requirements, including those are included in the table for

§§ 71.109, 71.111, 71.113, 71.115, mentioned previously and others completeness. The compatibility 71.117, 71.119, 71.121, 71.123, and referenced below in the table, would be categories are designated in the 71.125) are currently designated as re-designated as a Compatibility following table.

Section Change Subject Compatibility Existing New

71.0(d)(1)............................................. Revised........................... Purpose and Scope................................................. D D 71.4...................................................... New................................. Definition: Radiation Level....................................... [A]

71.4...................................................... Revised........................... Definition: Low Specific Activity (LSA) material [De-[B] [B]

letion of Low Specific ActivityIII Leaching Test].

71.4...................................................... Revised........................... Definition: Special form radioactive material........... [B] [B]

71.4...................................................... Revised........................... Definition: Surface Contaminated Object (SCO)..... [B] [B]

71.15(a) and (d).................................. Revised........................... Exemption from classification as fissile material..... [B] [B]

71.15(g)............................................... New................................. Exemption from classification as fissile material..... [B]

71.17(e)............................................... Revised........................... General license: NRC-approved package............... B B 71.19.................................................... Revised........................... Previously approved package.................................. NRC NRC 71.22(a), (c), and (e)(3) through (5).... Revised........................... General license: Fissile material.............................. [B] [B]

71.22(f) through (h)............................. New................................. General license: Fissile material.............................. [B]

71.23(a) and (c)................................... Revised........................... General license: Plutonium-beryllium special form [B] [B]

material.

71.23(f) through (h)............................. New................................. General license: Plutonium-beryllium special form [B]

material.

71.31(a)............................................... Revised........................... Contents of application............................................ NRC NRC 71.35(b) and (c)................................... Revised........................... Package evaluation.................................................. NRC NRC 71.35(d)............................................... New................................. Package evaluation.................................................. NRC 71.43(d)............................................... Revised........................... General standards for all packages......................... NRC NRC 71.43(i)................................................ New................................. General standards for all packages......................... NRC 71.55(g)............................................... Revised........................... General requirements for fissile material packages NRC NRC 71.71(c)(1)........................................... Revised........................... Normal conditions of transport................................. NRC NRC 71.73(b)............................................... Revised........................... Hypothetical accident conditions............................. NRC NRC 71.77.................................................... Removed........................ Qualification of LSAIII Material............................. NRC 71.95.................................................... Revised compatibility cat-Reports..................................................................... D **C egory.

71.95(a)(3)........................................... Removed........................ Reports..................................................................... D

• 71.97.................................................... Revised........................... Advance notification of shipment of irradiated reac-B B tor fuel and nuclear waste.

71.100.................................................. Revised........................... Criminal penalties.................................................... D D 71.101(b)............................................. Revised compatibility cat-Quality assurance requirements.............................. *** C *** B egory.

71.101(c)(1)......................................... Revised compatibility cat-Quality assurance requirements.............................. *** C ** B egory.

71.103(a) and (b)................................ Revised compatibility cat-Quality assurance organization............................... *** C ** B egory.

71.103(c), (d), (e) and (f).................... Revised compatibility cat-Quality assurance organization............................... D ** B egory.

71.105.................................................. Revised compatibility cat-Quality assurance program...................................... C ** B egory.

71.106.................................................. Revised compatibility cat-Changes to quality assurance program................... C ** B egory.

71.109.................................................. Revised compatibility cat-Procurement document control................................ NRC ** B egory.

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Section Change Subject Compatibility Existing New

71.111.................................................. Revised compatibility cat-Instructions, procedures and drawings.................... NRC ** B egory.

71.113.................................................. Revised compatibility cat-Document control..................................................... NRC ** B egory.

71.115.................................................. Revised compatibility cat-Control of purchased material, equipment, and NRC **B egory. services.

71.117.................................................. Revised compatibility cat-Identification and control of materials, parts and NRC **B egory. components.

71.119.................................................. Revised compatibility cat-Control of special processes................................... NRC ** B egory.

71.121.................................................. Revised compatibility cat-Internal inspection.................................................... NRC ** B egory.

71.123.................................................. Revised compatibility cat-Test control.............................................................. NRC ** B egory.

71.125.................................................. Revised compatibility cat-Control of measuring and test equipment............... NRC ** B egory.

71.127.................................................. Revised compatibility cat-Handling, storage, and shipping control.................. [C] ** B egory.

71.129.................................................. Revised compatibility cat-Inspection, test, and operating status...................... [C] ** B egory.

71.131.................................................. Revised compatibility cat-Nonconforming materials, parts, or components..... [C] ** B egory.

71.133.................................................. Revised compatibility cat-Corrective action...................................................... C ** B egory.

71.135.................................................. Revised compatibility cat-Quality assurance records....................................... *** C ** C egory.

71.137.................................................. Revised compatibility cat-Audits....................................................................... C **C egory.

Table A-1 in Appendix A to 10 CFR Revised........................... A1 and A2 Values for Radionuclides........................ [B] [B]

Part 71.

Table A-2 in Appendix A to 10 CFR Revised........................... Exempt Material Activity Concentrations and Ex-[B] [B]

Part 71. empt Consignment Activity Limits for Radio-nuclides.

• Denotes regulations that are designated Compatibility Category D but which will be removed from the regulations as a result of these pro-posed amendments. Agreement States that have an equivalent regulation should remove these provisions from their regulations when the regu-lations become final.

• • B/C (as designated)for Agreement States that have licensees that use Type B approved packages for shipping, other than for i ndustrial ra-diography, or have licensees that ship using the general license in § 71.21, § 71.22, or § 71.23, these regulations are required for compatibility purposes.

Dfor States that do not have licensees that use Type B approved packages for shipping, other than for industrial radiography, these regula-tions are not required for compatibility purposes.

• • • 10 CFR 71.101(g) indicates that QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated that this section satisfies § 71.17(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137).

The NRC invites comment on the voluntary consensus standards bodies, voluntary consensus standard is compatibility category designations in unless the use of such a standard is comparable and why it should be used.

the proposed rule and suggests that inconsistent with applicable law or This action does not constitute the commenters refer to Handbook 5.9 of otherwise impractical. In this proposed establishment of a standard that Management Directive 5.9, Adequacy rule, the NRC would revise regulations contains generally applicable and Compatibility of Program Elements associated with packaging and requirements.

for Agreement State Programs, for more transportation of radioactive material in XVII. Availability of Guidance information. The NRC notes that, like 10 CFR part 71 to conform NRC the rule text, the compatibility category regulations to the recent revisions to the The NRC is issuing for comment draft designations can change between the IAEA standards for the international guidance, DG-7011, Standard Format proposed rule and final rule on the basis transportation of radioactive material. and Content of Part 71 Applications for of comments received and Commission While the rule harmonizes NRC Approval of Packages for Radioactive decisions regarding the final rule. The requirements with IAEA Standard SSR-Material, Revision 3 to Regulatory NRC encourages anyone interested in 6, it does not endorse SSR-6, and SSR-Guide 7.9, for the implementation of the commenting on the compatibility 6 does not meet the criteria for being a requirements in this proposed rule. The category designations to do so during voluntary consensus standard under the draft guidance identifies the information the comment period. NTTAA. The NRC is not aware of any to be provided in an application for XVI. Voluntary Consensus Standards voluntary consensus standard that could package approval and establishes a be used. The NRC will consider using a uniform format for presenting that The National Technology Transfer voluntary consensus standard if an information. The draft guidance is and Advancement Act (NTTAA) of appropriate standard is identified. If a available in ADAMS under Accession 1995, Public Law 104-113, requires that voluntary consensus standard is No. ML22223A085. You may obtain Federal agencies use technical standards identified for consideration, the information and comment submissions that are developed or adopted by submittal should explain how the related to the draft guidance by

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searching on https:// being shipped. NUREG-1660 is which was recently issued, provides www.regulations.gov under Docket ID currently under revision to incorporate guidance to the NRC staff for reviewing NRC-2016-0179. You may submit requirements issued in both 10 CFR an application for package approval comments on the draft regulatory chapter I and 49 CFR chapter I since issued under 10 CFR part 71. There are guidance by the methods outlined in the 1999. The NRCs judgement is that there no changes being considered in this ADDRESSES section of this document. are no changes being considered in this proposed rule that would significantly The NRC considered whether a proposed rule that will affect the affect the content of NUREG-2216. The revision of NUREG-1608, Categorizing content of the revised NUREG-1660. NRC will first obtain experience using and Transporting Low Specific Activity The NRC considered whether a NUREG-2216 to evaluate whether there Materials and Surface Contaminated revision to NUREG-1886, Joint are more significant changes needed Objects, was warranted in association CanadaUnited States Guide for before making the relatively minor with this proposed rule. NUREG-1608, Approval of Type B(U) and Fissile changes associated with this proposed published jointly by the NRC and the Material Transportation Packages, is rule.

DOT in 1998, provides guidance to warranted in association with this shippers of LSA material and SCO rulemaking. NUREG-1886, published XVIII. Public Meeting regarding significant changes to both 10 jointly with the DOT and the Canadian CFR part 71 and 49 CFR that became Nuclear Safety Commission (CNSC) in The NRC will conduct a public effective April 1, 1996. The NRCs 2009, provides a standard format and meeting on this proposed rule to judgement is that NUREG-1608 serves content of an application for approval of describe it to the public and to facilitate the purpose for which it was intended, Type B(U) and fissile material packages the development of public comments.

which was to educate shippers about to demonstrate the ability of the given The NRC will publish a notice of the major changes to the regulations in package to meet both United States location, time, and agenda of the 1996, and that the minor changes to the (NRC and DOT regulations) and meeting on Regulations.gov and on the LSA and SCO requirements in this Canadian regulations. The NRC, the NRCs public meeting website at least 10 proposed rule do not warrant a revision DOT, and the CNSC recently started calendar days before the meeting.

to NUREG-1608. discussions to update NUREG-1886, Stakeholders should monitor the NRCs The NRC also considered whether a which will be a multiyear effort. When public meeting website for information revision of NUREG-1660, U.S.-Specific NUREG-1886 is updated, the NRC will about the public meeting at: https://

Schedules of Requirements for ensure that it is consistent with the final www.nrc.gov/public-involve/public-Transport of Specified Types of version of DG-7011 and its associated meetings/index.cfm.

Radioactive Material Consignments, Regulatory Guide 7.9.

was warranted in association with this The NRC considered whether a XIX. Availability of Documents proposed rule. NUREG-1660, published revision to NUREG-2216, Standard jointly by the NRC and the DOT in 1999, Review Plan for Transportation The documents identified in the provides summaries of NRC, DOT, and Packages for Spent Fuel and Radioactive following table are available to other regulations that shippers must Material, is warranted in association interested persons through one or more meet, depending on the type of material with this proposed rule. NUREG-2216, of the following methods, as indicated.

Document ADAMS accession No./web link/ Federal Register citation

Rulemaking Documents and References

SECY-20-0102 for this proposed rule........................................................................................... M L20101F921 Federal Register notice for this proposed rule.............................................................................. ML22209A035 Regulatory Analysis for this proposed rule..................................................................................... ML22209A039 Environmental Assessment for this proposed rule......................................................................... ML22209A045 OMB supporting statement for this proposed rule.......................................................................... ML22209A052 Draft regulatory basis document for this rulemaking, dated March 2019...................................... ML18262A185 Federal Register notification for draft regulatory basis, dated April 12, 2019.............................. 84 FR 14898 Draft regulatory basis comment submission #1.............................................................................. ML19106A347 Draft regulatory basis comment submission #2.............................................................................. ML19113A064 Draft regulatory basis comment submission #3.............................................................................. ML19143A311 Draft regulatory basis comment submission #4.............................................................................. ML19143A312 Draft regulatory basis comment submission #5.............................................................................. ML19148A147 Draft regulatory basis comment submission #6.............................................................................. ML19149A474 Draft regulatory basis comment submission #7.............................................................................. ML19150A140 NRC final rule amending packaging and transportation of radioactive material regulations, 80 FR 33988 dated June 12, 2015.

DOT final rule amending packaging and transportation of radioactive material regulations, 79 FR 40589 dated July 11, 2014.

NRC final rule harmonizing its regulations with the 1996 edition of IAEA Safety Series No. 6, 69 FR 3697 dated January 26, 2004.

NRC proposed rule harmonizing its regulations with the 1996 edition of IAEA Safety Series No. 67 FR 21390 6, dated April 30, 2002.

NRC final rule harmonizing its regulations with the 1985 edition of IAEA Safety Series No. 6, 60 FR 50248 dated September 28, 1995.

NRC/DOT Memorandum of Understanding, dated July 2, 1979.................................................... 44 FR 38690 SECY-16-0093, Rulemaking Plan for Revisions to Transportation Safety Requirements and ML16158A164 Harmonization with International Atomic Energy Agency Transportation Requirements, dated July 28, 2016.

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Document ADAMS accession No./web link/ Federal Register citation

Staff Requirements Memorandum SRM-SECY-16-0093, Staff RequirementsSECY ML16235A182 0093Rulemaking Plan for Revisions to Transportation Safety Requirements and Harmoni-zation with International Atomic Energy Agency Transportation Requirements, dated August 19, 2016.

Harmonization issues paper, Issues Paper on Potential Revisions to Transportation Safety Re-ML16299A298 paper, ML16299A291 package quirements and Harmonization with International Atomic Energy Agency Transportation Re-quirements, dated November 15, 2016.

Federal Register notification for harmonization issues paper, dated November 21, 2016.......... 81 FR 83171 Issues paper public meeting summary, Summary of the December 5 and 6, 2016 Public Meet-ML16343A661 ing on Issues Paper on Revisions to Transportation Safety Requirements and Harmonization with the International Atomic Energy Agency Transportation Requirements, dated December 14, 2016.

Draft Regulatory Guidance Document

Draft Regulatory Guide DG-7011, Standard Format and Content of Part 71 Applications for ML22223A085 Approval of Packages for Radioactive Material, Revision 3 of Regulatory Guide 7.9.

IAEA Transportation Safety Standards and Related References

SSR-6, Regulations for the Safe Transport of Radioactive Material, 2018 Edition................... https://www.iaea.org/publications/12288/regula-tions-for-the-safe-transport-of-radioactive-ma-terial SSR-6, Regulations for the Safe Transport of Radioactive Material, 2012 Edition................... https://www.iaea.org/publications/8851/regula-tions-for-the-safe-transport-of-radioactive-ma-terial-2012-edition TS-R-1, Regulations for the Safe Transport of Radioactive Material, 2009 Edition.................. https://www.iaea.org/publications/8005/regula-tions-for-the-safe-transport-of-radioactive-ma-terial-2009-edition TS-R-1, Regulations for the Safe Transport of Radioactive Material, 2005 Edition.................. https://www.iaea.org/publications/7291/regula-tions-for-the-safe-transport-of-radioactive-ma-terial-2005-edition TS-R-1, Regulations for the Safe Transport of Radioactive Material, 1996 Edition.................. https://www.iaea.org/publications/6056/regula-tions-for-the-safe-transport-of-radioactive-ma-terial-1996-edition-revised Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1985 Edition http://gnssn.iaea.org/Superseded%20 (As Amended in 1990). Safety%20Standards/Safety_Series_006_

1990.pdf Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1985 Edition https://gnssn.iaea.org/Superseded%20 Safety%20Standards/Safety_Series_006_

1985.pdf Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1973 Edition https://gnssn.iaea.org/Superseded%20 Safety%20Standards/Safety_Series_006_

1973.pdf Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1967 Edition https://gnssn.iaea.org/Superseded%20 Safety%20Standards/Safety_Series_006_

1967.pdf

Other International Standards References

ANSI N14.1-2012, Nuclear MaterialsUranium HexafluoridePackagings for Transport, https://webstore.ansi.org/standards/pcc/

dated December 3, 2012. ansin142012 ANSI N14.5-2014, American National Standard for Radioactive MaterialsLeakage Tests on https://webstore.ansi.org/standards/pcc/

Packages for Shipment, dated June 19, 2014. ansin142014 International Organization for Standardization 7195:2005, Nuclear EnergyPackaging of Ura-https://www.iso.org/standard/31251.html nium Hexafluoride (UF6) for Transport, dated September 2005.

American National Standards Institute/American Nuclear Society 8.1-2014 (Reaffirmed 2018), https://webstore.ansi.org/Standards/ANSI/

Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors, Amer-ANSIANS2014R2018 ican Nuclear Society, La Grange Park, IL.

Miscellaneous References

National Renewable Energy Laboratory Solar Radiation Data...................................................... https://www.nrel.gov/gis/assets/images/solar-annual-ghi-2018-usa-scale-01.jpg NRC letter to Agreement States, Clarification of Title 10 of the Code of Federal Regulations, ML17213A844 Part 71 Requirements Identified in Regulation Amendment Tracking System Identification Number RATS ID: 2015-3 (STC-17-060), dated August 15, 2017.

Presidential Memorandum, Plain Language in Government Writing, published June 10, 1998 63 FR 31885 Agreement State Program Policy Statement, dated October 18, 2017......................................... 82 FR 48535 NRC Management Directive 5.9, Handbook 5.9, Adequacy and Compatibility of Program Ele-ML18081A070 ments for Agreement State Programs, dated April 26, 2018.

NRC Management Directive 8.4, Management of Backfitting, Forward Fitting, Issue Finality, ML18093B087 and Information Requests, dated September 20, 2019.

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Document ADAMS accession No./web link/ Federal Register citation

ORNL/TM-2014/658, Comparison of the International and United States Domestic Radioactive https://rampac.energy.gov/docs/default-source/

Material Transport Regulations, dated September 30, 2014. doeinfo/ORNL-TM-2014-658.pdf NUREG-1409, Backfitting Guidelines, Revision 1, draft for public comment, dated March ML18109A498 2020.

NUREG-1608, Categorizing and Transporting Low Specific Activity Materials and Surface ML15336A927 Contaminated Objects, dated July 1998.

NUREG-1660, U.S.-Specific Schedules of Requirements for Transport of Specified Types of https://rampac.energy.gov/docs/default-source/

Radioactive Material Consignments, dated January 1999. nrcinfo/nureg_1660.pdf NUREG-1886, Joint Canada-United States Guide for Approval of Type B(U) and Fissile Ma-ML090930197 terial Transportation Packages, dated March 2009.

NUREG-2216, Standard Review Plan for Transportation Packages for Spent Fuel and Radio-ML20234A651 active Material, dated August 2020.

Throughout the development of this § 71.0 Purpose and scope. shielding material, does not exceed 2 x proposed rule, the NRC may post * * * *

• 10¥3A2/g.

documents related to it, including (d)(1) Exemptions from the * * * *

• public comments, on the Federal requirement for license in § 71.3 are Radiation level means the radiation rulemaking website at https:// specified in § 71.14. The general license dose equivalent rate expressed in www.regulations.gov under Docket ID in § 71.21 does not require NRC package millisieverts per hour or mSv/h NRC-2016-0179. In addition, the approval. The general licenses in (millirems per hour or mrem/h).

Federal rulemaking website allows §§ 71.22 and 71.23 require NRC package * * * *

• members of the public to receive alerts approval if the quantities exceed a Type Special form radioactive material when changes or additions occur in a A quantity. The general license in means radioactive material that satisfies docket folder. To subscribe: (1) navigate § 71.17 requires that an NRC certificate the following conditions:

to the docket folder (NRC-2016-0179); of compliance or other package approval (1) It is either a single solid piece or (2) click the Subscribe link; and 3) be issued for the package to be used is contained in a sealed capsule that can enter an email address and click on the under this general license. be opened only by destroying the Subscribe link. * * * *

• capsule; List of Subjects in 10 CFR Part 71 3. Amend § 71.4 by: (2) The piece or capsule has at least

a. Revising the definitions for Low one dimension not less than 5 mm (0.2 Criminal penalties, Hazardous Specific Activity material and Special in); and materials transportation, form radioactive material; (3) It satisfies the requirements of Intergovernmental relations, Nuclear b. Revising the introductory text and § 71.75. A special form encapsulation materials, Packaging and containers, add paragraph (3) for Surface designed in accordance with the Penalties, Radioactive materials, contaminated object; and requirements of § 71.4 in effect from Reporting and recordkeeping c. Adding the definition Radiation April 1, 1996, to September 30, 2004, requirements. level in alphabetical order. may continue to be used, provided that For the reasons set out in the The revisions and addition read as fabrication of the special form preamble and under the authority of the follows: encapsulation was successfully Atomic Energy Act of 1954, as amended; § 71.4 Definitions. completed by [DATE ONE DAY PRIOR the Energy Reorganization Act of 1974, * * * *

• TO EFFECTIVE DATE OF FINAL as amended; and 5 U.S.C. 552 and 553, Low Specific Activity (LSA) material RULE]. A special form encapsulation the NRC is proposing to adopt the means radioactive material with limited designed in accordance with the following amendments to 10 CFR part specific activity which is nonfissile or is requirements of § 71.4 in effect from 71: exempt under § 71.15, and which October 1, 2004, to [DATE ONE DAY satisfies the descriptions and limits set PRIOR TO EFFECTIVE DATE OF FINAL PART 71PACKAGING AND forth in the following section. Shielding RULE] may continue to be used, TRANSPORTATION OF RADIOACTIVE materials surrounding the LSA material provided that fabrication of the special MATERIAL may not be considered in determining form encapsulation is successfully the estimated average specific activity of completed by December 31, 2025. Any

1. The authority citation for part 71 the package contents. The LSA material other special form encapsulation must continues to read as follows: must be in one of three groups: meet the specifications of this Authority: Atomic Energy Act of 1954, * * * *

• definition.

secs. 53, 57, 62, 63, 81, 161, 182, 183, 223, (3) LSAIII. Solids ( e.g., consolidated * * * *

• 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, wastes, activated materials), excluding Surface contaminated object (SCO) 2111, 2201, 2232, 2233, 2273, 2282, 2297f); powders, in which: means a solid object that is not itself Energy Reorganization Act of 1974, secs. 201, (i) The radioactive material is classed as radioactive material, but 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, distributed throughout a solid or a which has radioactive material 5851); Nuclear Waste Policy Act of 1982, sec. collection of solid objects, or is distributed on any of its surfaces. SCO 180 (42 U.S.C. 10175); 44 U.S.C. 3504 note. essentially uniformly distributed in a must be in one of three groups with Section 71.97 also issued under Sec. 301, solid compact binding agent (such as surface activity not exceeding the Pub. L.96-295, 94 Stat. 789 (42 U.S.C. 5841 concrete, bitumen, ceramic, etc.); and following limits:

note). (ii) [Reserved] * * * * *

2. In § 71.0, revise paragraph (d)(1) to (iii) The estimated average specific (3) SCOIII: A large solid object read as follows: activity of the solid, excluding any which, because of its size, cannot be

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transported in a type of package (e) For a Type B or fissile material identification number suffix AF, B(U),

described in 49 CFR 173.403 of the DOT package, the design of which was B(M), B(U)F, B(M)F, after receipt of an regulations and for which: approved by NRC before [EFFECTIVE application demonstrating that the (i) All openings are sealed to prevent DATE OF FINAL RULE], the general design meets the requirements of this release of radioactive material during license is subject to the additional part.

conditions defined in 49 CFR restrictions of § 71.19. 7. In § 71.22, revise paragraphs (a), (c),

173.427(d); 6. Amend § 71.19 by: and (e)(3) through (5) and add (ii) The inside of the object is as dry a. Revising paragraph (a); paragraphs (f) through (h) to read as as practicable; b. Redesignating paragraphs (c) and follows:

(iii) The nonfixed contamination on (d) as paragraphs (d) and (e); § 71.22 General license: Fissile material.

the external surface does not exceed the c. Adding new paragraph (c); and (a) A general license is issued to any contamination limits specified in the d. Revising newly redesignated licensee of the Commission to transport DOT regulations in 49 CFR 173.443; and paragraph (e). fissile material, or to deliver fissile (iv) The nonfixed contamination plus The revisions and addition read as material to a carrier for transport, if the the fixed contamination on the follows: material is shipped in accordance with inaccessible surface averaged over 300 § 71.19 Previously approved package. this section. The fissile material need cm2 does not exceed 8 x 105 Bq/cm2 (20 (a) A Type B(U) package, a Type B(M) not be contained in a package which microcuries/cm2) for beta and gamma package, or a fissile material package, meets the standards of §§ 71.55 and emitters and low toxicity alpha emitters, previously approved by the NRC but 71.59. However, the material must be or 8 x 104 Bq/cm2 (2 microcuries/cm2) without the designation -85 or -96 contained in a Type A or Type B for all other alpha emitters. in the identification number of the NRC package, consistent with the quantity of

• * * *

• CoC, may be used under the general radioactive material in the package.

4. In § 71.15, revise the introductory license of § 71.17 with the following * * * *

• text and paragraphs (a) and (d) and add additional conditions: (c) The general license applies only paragraph (g) to read as follows: (1) Fabrication of the package is when a packages contents contain less

§ 71.15 Exemption from classification as satisfactorily completed by April 1, than 500 total grams of beryllium, fissile material. 1999, as demonstrated by application of graphite, or hydrogenous material Fissile material meeting the its model number in accordance with enriched in deuterium.

requirements of at least one of the § 71.85(c); * * * *

• paragraphs (a) through (g) of this section (2) A serial number which uniquely (e) * *

• are exempt from classification as fissile identifies each packaging which (3) The values of X, Y, and Z used in material and from the fissile material conforms to the approved design is the CSI equation must be taken from package standards of §§ 71.55 and 71.59 assigned to and legibly and durably Table 71-1 or 71-2, as appropriate but are subject to all other requirements marked on the outside of each based on criteria from § 71.22(e)(4) and of this part, except as noted. packaging; and (5).

(a) Individual package containing: (3) Paragraph (a) of this section (4) If Table 71-2 is used to obtain the (1) 2 grams or less fissile material, or expires [DATE 8 YEARS AFTER value of X, then:

(2) 3.5 grams or less uranium-235, EFFECTIVE DATE OF THE FINAL (i) The total mass of plutonium and provided the uranium is enriched in RULE]. uranium-233 must not exceed 1 percent uranium-235 to a maximum of 5 percent * * * *

• of the mass of uranium-235; by weight, and the total plutonium and (c) A Type B(U) package, a Type B(M) (ii) Values for the terms in the uranium-233 content does not exceed 1 package, or a fissile material package equation for uranium-233 and percent of the mass of uranium-235. previously approved by the NRC with plutonium must be assumed to be zero;

• * * *

• the designation -96 in the and (d) Uranium enriched in uranium-235 identification number of the NRC CoC, (iii) The value of the uranium to a maximum of 1 percent by weight, may be used under the general license enrichment must be known and be less and with total plutonium and uranium-of § 71.17 with the following additional than the enrichment value used from 233 content not exceeding 1 percent of conditions: Table 71-2.

the mass of uranium-235, provided that (1) Fabrication of the package must be (5) Table 71-1 values for X, Y, and Z the mass of any beryllium, graphite, and satisfactorily completed by January 1, must be used to determine the CSI if:

hydrogenous material enriched in 2029, as demonstrated by application of (i) The total mass of plutonium and deuterium constitutes less than 5 its model number in accordance with uranium-233 exceeds 1 percent of the percent of the uranium mass, and that § 71.85(c); and mass of uranium-235; the fissile material is distributed (2) A package used for a shipment to (ii) The uranium is of unknown homogeneously and does not form a a location outside the United States, uranium-235 enrichment or greater than lattice arrangement within the package. after December 31, 2025, is subject to 24 weight percent enrichment; or

• * * *

• multilateral approval, as defined in the (iii) Substances having a moderating (g) Packages transported under DOTs regulations at 49 CFR 173.403. effectiveness (i.e., an average hydrogen exclusive use on a conveyance * * * *

• density greater than H2O) (e.g., certain containing a total of 140 grams or less (e) NRC will revise the package hydrocarbon oils or plastics) are present fissile material. identification number to designate in any form, except as polyethylene

5. In § 71.17, revise paragraph (e) to previously approved package designs used for packing or wrapping. * *

• read as follows: that were designated as AF, B(U), B(M), * * * *

• B(U)F, B(M)F, B(U)-85, B(U)F-85, (f) Each licensee using the general

§ 71.17 General license: NRC-approved B(M)-85, B(M)F-85, AF-85, B(U)-96, license under paragraph (a) of this package. B(U)F-96, B(M)-96, B(M)F-96, or AF-section to transport a Type B quantity of

• * * *

• 96 as appropriate, with the licensed material must use a package for

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which a license, CoC, or other approval § 71.31 Contents of application. the tests specified in §§ 71.71 and 71.73, has been issued by the NRC, and must (a) An application for an approval there would be adequate space to comply with the provisions in under this part must include, for each accommodate variations in temperature

§ 71.17(c). proposed packaging design, the of the liquid, dynamic effects, and (g) For shipment of a Type B quantity following information: filling dynamics.

of licensed material, this general license (1) A package description as required 12. In § 71.55, revise paragraph (g)(1) applies only when the package approval by § 71.33; to read as follows:

authorizes use of the package under the (2) A package evaluation as required general license in § 71.17 or this general by § 71.35; § 71.55 General requirements for fissile license. (3) A maintenance program material packages.

(h) For a Type B package, the design description, as required by § 71.35; and * * * *

• of which was approved by NRC before (4) A quality assurance program (g) * * *

[EFFECTIVE DATE OF FINAL RULE], description, as required by § 71.37, or a (1) Following the tests specified in this general license is subject to the reference to a previously approved § 71.73 (Hypothetical accident additional restrictions of § 71.19. quality assurance program. conditions), there is no physical

8. In § 71.23, revise paragraph (a) and * * * *

• contact between the valve body or the the introductory text of paragraph (c) 10. In § 71.35, revise paragraphs (b) plug and any other component of the and add paragraphs (f) through (h) to and (c) and add paragraph (d) to read as packaging, other than at its original read as follows: follows: point of attachment, and the valve and

§ 71.35 Package evaluation. plug remain leak tight;

§ 71.23 General license: Plutonium- * * * * * * * * *

• beryllium special form material. 13. In § 71.71, in the table in (a) A general license is issued to any (b) For a fissile material package, the paragraph (c)(1), revise the heading of licensee of the Commission to transport allowable number of packages that may the second column to read as follows:

fissile material in the form of be transported in the same vehicle in plutonium-beryllium (Pu-Be) special accordance with § 71.59; § 71.71 Normal conditions of transport.

form sources, or to deliver Pu-Be special (c) For a fissile material shipment, any * * * *

• form sources to a carrier for transport, proposed special controls and (c) * *

• if the material is shipped in accordance precautions for transport, loading, (1) * *

• with this section. This material need not unloading, and handling and any be contained in a package which meets proposed special controls in case of an INSOLATION DATA the standards of §§ 71.55 and 71.59. accident or delay; and However, the fissile material must be (d) A maintenance program to assure that the packaging will perform as * * *.............. Total insolation for a 12-hour contained in a Type A or Type B intended throughout its time in service. period (W/m2) package, consistent with the quantity of The maintenance program must include radioactive material in the package. periodic testing requirements, *****

• * * *

• inspections, and replacement criteria * * * * *

(c) The general license applies only and schedules for replacement and 14. In § 71.73, revise paragraph (b) to when a packages contents contain less repairs of components on an as-needed read as follows:

than 1000 grams of plutonium, provided basis.

that plutonium-239, plutonium-241, or 11. In § 71.43, revise paragraph (d) § 71.73 Hypothetical accident conditions.

any combination of these radionuclides, and add paragraph (i) to read as follows: * * * *

• constitutes less than 240 grams of the § 71.43 General standards for all (b) Test conditions. Except for the total quantity of plutonium in the packages. water immersion test, the following package. * * * *

• conditions shall apply before and after

• * * * * (d) A package must be made of the tests:

(f) Each licensee using the general materials and construction that assure (1) The ambient air temperature shall license under paragraph (a) of this that there will be no significant remain constant at that value between section to transport a Type B quantity of chemical, galvanic, or other reaction ¥29 °C (¥20 °F) and +38 °C (+100 °F) licensed material must use a package for among the packaging components, which is most unfavorable for the which a license, CoC, or other approval among package contents, or between the feature under consideration; has been issued by the NRC, and must packaging components and the package (2) The insolation shall be that value comply with the provisions in contents, including possible reaction between 0 and the maximum value

§ 71.17(c). resulting from inleakage of water, to the listed in the Insolation Data Table in (g) For shipment of a Type B quantity maximum credible extent. The effects of § 71.71(c)(1), which is most unfavorable of licensed material, this general license the aging mechanisms and the behavior for the feature under consideration; and applies only when the package approval of materials under irradiation must be (3) The initial internal pressure authorizes use of the package under the evaluated on package components to within the containment system must be general license in § 71.17 or this general show that their performance is not the maximum normal operating license. significantly degraded or that pressure, unless a lower internal (h) For a Type B package, the design degradation will be managed by the pressure, consistent with the ambient of which was approved by NRC before maintenance program in accordance temperature assumed to precede and

[EFFECTIVE DATE OF FINAL RULE], with § 71.35(d). follow the tests, is more unfavorable.

this general license is subject to the * * * * * * * * *

• additional restrictions of § 71.19. (i) Each system designed for holding

9. In § 71.31, revise paragraph (a) to liquids must be designed, constructed, § 71.77 [Removed and Reserved]

read as follows: and prepared for shipment so that under 15. Remove and reserve § 71.77.

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§ 71.95 [Amended] § 71.106 Changes to quality assurance or editorial items, the following changes

16. In § 71.95, remove paragraph program. are not considered reductions in (a)(3). * * * *

• commitment:

(b) Each quality assurance program * * * * *

§ 71.97 [Amended] approval holder may change a 20. In appendix A to part 71, in

17. In § 71.97: previously approved quality assurance paragraph V.b.:

a. In the section heading, remove the program without prior NRC approval, if a. In Table A-1, add the entries for Ba-phrase irradiated reactor fuel and; the change does not reduce the 135m, Ge-69, Ir-193m, Ni-57, Sr-83, Tb-

b. In paragraph (b) introductory text, commitments in the quality assurance 149, and Tb-161 in alphanumeric order remove the word also; program previously approved by the and revise the entries for Ni-59, Rb(nat),

c. In paragraph (d) introductory text NRC. Changes to the quality assurance and Tb-157; and and paragraphs (d)(1) and (2), remove program that do not reduce the b. In Table A-2, add the entries for Ba-the phrase irradiated reactor fuel or; commitments shall be submitted to the 135m, Ge-69, Ir-193m, Ni-57, Sr-83, Tb-and NRC every 24 months, in accordance 149, and Tb-161 in alphanumeric order

d. In paragraph (f)(1), remove the with § 71.1(a). If no changes were made and revise the entries for Ni-59, Tb-157, phrase an irradiated reactor fuel or to the quality assurance program this Th(nat), and U(nat).

and add in its place the word a. information shall also be submitted to The additions and revisions read as the NRC every 24 months, in accordance follows:

§ 71.100 [Amended] with § 71.1(a). In addition to quality

18. In § 71.100(b), remove the assurance program changes involving Appendix A to Part 71Determination reference 71.77,. administrative improvements and of A1 and A2

19. In § 71.106, revise the introductory clarifications, spelling corrections, and * * * *

• text of paragraph (b) to read as follows: non-substantive changes to punctuation V.b. * *

• TABLE A-1A 1 AND A2 VALUES FOR RADIONUCLIDES

Symbol of radionuclide Element and atomic number A1(TBq) A1 (Ci)b A2(TBq) A2 (Ci)b Specific activity (TBq/g) (Ci/g)

Ba-135m............................................ 2.0 x 101.............. 5.4 x 102.............. 6.0 x 10¥1........... 1.6 x 101.............. 3.0 x 104.............. 8.1 x 105

Ge-69................................................. 1.0 x 100.............. 2.7 x 101.............. 1.0 x 100.............. 2.7 x 101.............. 4.3 x 104.............. 1.2 x 106

Ir-193m............................................... 4.0 x 101.............. 1.1 x 103.............. 4.0 x 100.............. 1.1 x 102.............. 2.4 x 103.............. 6.4 x 104

Ni-57.................... Nickel (28)........... 6.0 x 10¥1........... 1.6 x 101.............. 5.0 x 10¥1........... 1.4 x 101.............. 5.7 x 104.............. 1.5 x 106 Ni-59.................................................. Unlimited............. Unlimited............. Unlimited............. Unlimited............. 3.0 x 10¥3........... 8.0 x 10¥2

Rb(nat)............................................... Unlimited............. Unlimited............. Unlimited............. Unlimited............. 6.7 x 10¥10......... 1.8 x 10¥8

Sr-83.................................................. 1.0 x 100.............. 2.7 x 101.............. 1.0 x 100.............. 2.7 x 101.............. 4.3 x 104.............. 1.2 x 106

Tb-149.................. Terbium (65)........ 8.0 x 10¥1........... 2.2 x 101.............. 8.0 x 10¥1........... 2.2 x 101.............. 1.9 x 105.............. 5.1 x 106 Tb-157................................................ 4.0 x 101.............. 1.1 x 103.............. 4.0 x 101.............. 1.1 x 103.............. 5.6 x 10¥1........... 1.5 x 101

Tb-161................................................ 3.0 x 101.............. 8.1 x 102.............. 7.0 x 10¥1........... 1.9 x 101.............. 4.3 x 103.............. 1.2 x 105

TABLE A-2E XEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES

Activity Activity Activity limit Activity limit Symbol of concentration for concentration for for exempt for exempt radionuclide Element and atomic number exempt material exempt material consignment consignment (Bq/g) (Ci/g) (Bq) (Ci)

Ba-135m....................................................... 1.0 x 102................... 2.7 x 10¥9................ 1.0 x 106................... 2.7 x 10¥5

Ge-69............................................................ 1.0 x 101................... 2.7 x 10¥10............... 1.0 x 106................... 2.7 x 10¥5

Ir-193m.......................................................... 1.0 x 104................... 2.7 x 10¥7................ 1.0 x 107................... 2.7 x 10¥4

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TABLE A-2E XEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDESContinued

Activity Activity Activity limit Activity limit Symbol of concentration for concentration for for exempt for exempt radionuclide Element and atomic number exempt material exempt material consignment consignment (Bq/g) (Ci/g) (Bq) (Ci)

Ni-57.......................... Nickel (28)................. 1.0 x 101................... 2.7 x 10¥10............... 1.0 x 106................... 2.7 x 10¥5 Ni-59............................................................. 1.0 x 104................... 2.7 x 10¥7................ 1.0 x 108................... 2.7 x 10¥3

Sr-83............................................................. 1.0 x 101................... 2.7 x 10¥10............... 1.0 x 106................... 2.7 x 10¥5

Tb-149........................ Terbium (65)............. 1.0 x 101................... 2.7 x 10¥10............... 1.0 x 106................... 2.7 x 10¥5 Tb-157........................................................... 1.0 x 104................... 2.7 x 10¥7................ 1.0 x 107................... 2.7 x 10¥4

Tb-161........................................................... 3.0 x 101................... 8.1 x 102................... 7.0 x 10¥1................ 1.9 x 101

Th(nat) (b), (c).............................................. 1.0............................. 2.7 x 10¥11............... 1.0 x 103................... 2.7 x 10¥8

U(nat) (b), (c)................................................ 1.0............................. 2.7 x 10¥11............... 1.0 x 103................... 2.7 x 10¥8

b Parent nuclides and their progeny included in secular equilibrium are listed as follows:

Sr-90....................... Y-90 Zr-93....................... Nb-93m Zr-97....................... Nb-97 Ru-106.................... Rh-106 Ag-108m................. Ag-108 Cs-137.................... Ba-137m Ce-144.................... Pr-144 Ba-140.................... La-140 Bi-212...................... Tl-208 (0.36), Po-212 (0.64)

Pb-210.................... Bi-210, Po-210 Pb-212.................... Bi-212, Tl-208 (0.36), Po-212 (0.64)

Rn-222.................... Po-218, Pb-214, Bi-214, Po-214 Ra-223.................... Rn-219, Po-215, Pb-211, Bi-211, Tl-207 Ra-224.................... Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

Ra-226.................... Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 Ra-228.................... Ac-228 Th-228..................... Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212(0.64)

Th-229..................... Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 Th-nat...................... Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

Th-234..................... Pa-234m U-230...................... Th-226, Ra-222, Rn-218, Po-214 U-232...................... Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

U-235...................... Th-231 U-238...................... Th-234, Pa-234m U-nat....................... Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 Np-237.................... Pa-233 Am-242m................ Am-242 Am-243................... Np-239

c In the case of Th(nat), the parent nuclide is Th-232; in the case of U(nat), the parent nuclide is U-238.

Dated August 22, 2022. For the Nuclear Regulatory Commission.

Brooke P. Clark, Secretary of the Commission.

[FR Doc. 2022-18520 Filed 9-9-22; 8:45 am]

BILLING CODE 7590-01-P

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