Table of Contents I. Obtaining Information and Submitting Comments A. Obtaining Information B. Submitting Comments II. Background III. Discussion A. Action the NRC is Proposing To Take B. Applicability of the Proposed Action C. Discussion of Issues Specific Request for Comment IV. Specific Request for Comment V. Section-by-Section Analysis VI. Regulatory Flexibility Certification VII. Regulatory Analysis VIII. Backfitting and Issue Finality IX. Cumulative Effects of Regulation X. Plain Writing XI. Environmental Assessment and Proposed Finding of No Significant Environmental Impact XII. Paperwork Reduction Act XIII. Criminal Penalties XIV. Coordination with NRC Agreement States XV. Compatibility of Agreement State Regulations XVI. Voluntary Consensus Standards XVII. Availability of Guidance XVIII. Public Meeting XIX. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2016-0179 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2016-0179.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents, by appointment, at the PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

Please include Docket ID NRC-2016-0179 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

On June 12, 2015, the NRC, in consultation with the U.S. Department of Transportation (DOT), published a final rule that amended the NRC's regulations for the packaging and transportation of radioactive material (80 FR 33988; June 12, 2015). These amendments made conforming changes to the NRC's regulations based on the standards of the International Atomic Energy Agency (IAEA). That final rule, in combination with a DOT final rule (79 FR 40589; July 11, 2014) amending title 49 of the Code of Federal Regulations (49 CFR), brought U.S. regulations into general accord with the 2009 Edition of the IAEA's “Regulations for the Safe Transport of Radioactive Material” (TS-R-1). The IAEA has since updated its standards for the transport of radioactive material in “Regulations for the Safe Transport of Radioactive Material,” Specific Safety Requirements No. 6 (SSR-6) (2012 and 2018 Editions).

The IAEA develops international safety standards for the safe transport of radioactive material. The IAEA safety standards are developed in consultation with the competent authorities of Member States, so they reflect an international consensus on what is needed to provide for a high level of safety. By providing a global framework for the consistent regulation of the transport of radioactive material, IAEA safety standards facilitate international commerce and contribute to the safe conduct of international trade involving radioactive material. By periodically revising its regulations to be compatible with IAEA standards and DOT regulations, the NRC can remove inconsistencies that could impede international commerce.

The roles of the DOT and the NRC in the coregulation of the transportation of radioactive materials are documented in a Memorandum of Understanding (44 FR 38690; July 2, 1979). Because of the coregulation of the transportation of radioactive materials in the United States, the NRC and the DOT have historically coordinated to harmonize their respective regulations with the IAEA revisions through the rulemaking process. In the NRC's previous 10 CFR part 71 harmonization rulemaking, published in the Federal Register on June 12, 2015, the Commission stated that the NRC will consider any necessary changes related to SSR-6 in a future rulemaking after consulting with DOT.

The NRC engaged with the DOT in the development of this proposed rule to identify and evaluate gaps between 10 CFR part 71 regulations and the updated IAEA standards in SSR-6, 2018 Edition. This proposed rule would close those gaps where warranted. Harmonizing NRC regulations with the 2018 Edition of SSR-6 includes changes made in the 2012 Edition of SSR-6 that have been carried forward to the 2018 Edition. The DOT is undertaking a similar initiative to harmonize its regulations in 49 CFR parts 107 and 171-180 with the 2018 Edition of SSR-6.

The NRC reviewed the 2018 Edition of SSR-6 and identified 10 regulatory issues for harmonization with the IAEA and another 4 NRC-initiated changes to 10 CFR part 71 to be evaluated during the rulemaking development process. Fourteen of these issues were documented in the “Issues Paper on Potential Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements” (issues paper). The issues paper, public meeting, and request for comment were published in the Federal Register (81 FR 83171; November 21, 2016). The NRC held a public meeting on December 5-6, 2016, to discuss the issues paper, and the DOT participated in that public meeting. A summary of the public meeting, including the attendance list, was issued on December 14, 2016. After the public meeting, the NRC received 49 comment submissions on the issues paper identified comments that are pertinent to this proposed rule, and considered these comments in the development of a draft regulatory basis. In addition to the 14 issues documented in the paper, the NRC identified other potential changes to the regulations, including clarifications to ensure compatibility with the DOT and changes to the compatibility categories for Agreement State regulations. These potential changes were grouped under a new issue that was designated as Issue 15 in the draft regulatory basis. All 15 issues are described in Section III of this document.

On April 12, 2019, the NRC published the draft regulatory basis for this proposed rule in the Federal Register and requested public comments (84 FR 14898; April 12, 2019). In the regulatory basis, the NRC evaluated four alternative actions for each issue. These were: Alternative 1—take no action and maintain the status quo; Alternative 2—issue generic communications and regulatory guidance; Alternative 3—issue license-specific conditions and exemptions; and Alternative 4-initiate a rulemaking action to revise 10 CFR part 71. The alternatives were evaluated based on their viability to resolve the regulatory issues of concern and estimates of their costs and potential benefits. The NRC determined that the rulemaking action, Alternative 4, for Issues 1 (in part), 2, and 4-15, in combination with the no-action alternative, Alternative 1, for Issue 3, was the NRC-recommended action because it represented the most effective and least-costly option. Alternatives 2 and 3 would not address all of the regulatory issues or would result in higher costs to the NRC and industry.

The NRC also held a public meeting on April 30, 2019, to discuss the draft regulatory basis and answer questions. The NRC received seven public comment submissions on the draft regulatory basis—three with general comments on the rulemaking and four with comments on specific issues—as well as comments that were considered outside the scope of this proposed rule. All three general comments were supportive of the harmonization effort with IAEA SSR-6. The NRC did not receive any comments on Issues 2, 6, and 14. The NRC received comments supportive of the proposal for Issues 4b, 11, 12, 13 and 15, along with comments supportive of other issues which also recommended modifications to the NRC's proposed changes. One comment on Issue 5 proposed the NRC add a definition of “radiation level” to 10 CFR part 71, which the NRC included in this proposed rule.

One comment on Issue 1 stated that the fissile exemption mass limits in 10 CFR part 71 should match those in SSR-6, paragraph 417, to avoid confusion for international shipments from the United States. The NRC has determined that its regulations for fissile exemption mass limits should differ from the IAEA's requirements to provide flexibility for shippers. Specifically, the NRC requirements in this proposed rule would adopt a 3.5-gram limit from SSR-6, paragraph 417(c), but without the associated consignment limit found in paragraph 570(c); they also would adopt a higher mass limit than SSR-6, paragraph 417(e). Several existing fissile exemptions under § 71.15 do not have corresponding exceptions under SSR-6, paragraph 417; if the NRC made 10 CFR part 71 fissile exemptions identical to the fissile exceptions in SSR-6, paragraph 417, fissile material licensees would lose the benefit of these exemptions. Also, the NRC is not pursuing the competent authority-approved exception in SSR-6, paragraph 417(f). The NRC has determined that the current fissile exemptions under § 71.15 provide flexibility for shipping low masses or concentrations of fissile materials, and licensees can submit a specific exemption request under § 71.12 for fissile materials that do not meet the fissile exemption criteria in § 71.15.

The NRC received comments on Issues 4 and 8 which suggested that the NRC “grandfather” packages from having to meet the revised requirements. The NRC is proposing to “grandfather” older packages as discussed in Issue 10, “Transitional Arrangements.”

Comments on Issue 4 on the proposed insolation requirements stated that these requirements would present challenges to certificate holders, including cost to certificate holders to evaluate the new conditions; changing the units without revising the corresponding values may result in decreasing margins or exceeding thermal limits; and the insolation values are referenced in other documents, which may have an impact to the thermal evaluations for storage systems certified under 10 CFR part 72. While the NRC agrees there will be costs with evaluating the new insolation requirements, the NRC estimates that the cost for existing certificates to show compliance with the revised insolation will be small, since the increased insolation load would be approximately 3 percent. In addition, harmonizing NRC requirements with those of IAEA will ensure that packages approved by the NRC would also be acceptable in other countries where they might be used for international transport. The NRC made no changes as a result of this comment. The NRC recognizes that all packages age over time and that aging effects should be considered for all packages, not just for dual-purpose packages.

The NRC received comments on Issue 9 opposing the addition of an aging management program to 10 CFR part 71. The commenters stated that, if such a program were added, the program should be limited to packages other than dual-purpose spent nuclear fuel packages/canisters. The NRC is not proposing to impose a requirement for an aging management plan. The proposed rule includes requirements that aging effects are evaluated in the application for approval and that the application for approval include a maintenance program. Another comment on Issue 9 supported evaluating aging effects but only for dual-purpose spent fuel packages, excluding packages that are not kept in long-term storage prior to transport.

One comment on Issue 10 supported phasing out older packages as proposed in transitional arrangements but suggested a phase-out period longer than 4 years. The NRC agreed and is proposing an 8-year phase out of older packages. As part of the NRC's 2004 amendment to 10 CFR part 71 (69 FR 3697; January 26, 2004), certain transportation packages, those compatible with the 1967 edition of Safety Series No. 6, became unauthorized for use under the 10 CFR part 71 general license after October 1, 2008. The NRC received requests to extend the phase-out date beyond the initial 4-year period to allow sufficient time to design, obtain approval for, and fabricate new packages. Given this experience, in this proposed rule, the NRC has selected a phase-out period of 8 years to give certificate holders sufficient time to conduct these activities, if needed. The NRC estimates that it could take 2 to 4 years for design of a new package and preparation of an application, 1 to 2 years for package approval, and 1 to 2 years for package fabrication, depending on the package's complexity. Another comment on Issue 10 on transitional arrangements stated that the NRC should not phase out packages with a “-96” in the package identification number and that the proposed phase out of packages did not consider the cost impact for designing new packages. The NRC is not proposing to phase out packages with a “-96” in the proposed rule, but rather proposing to phase out packages that do not have either a “-85” or a “-96” in the package identification number ( i.e., packages approved before April 1, 1996). The NRC included the cost of designing a new package in the regulatory analysis for the proposed rule.

The NRC received one comment on Issue 12 on the proposed quality assurance program (QAP) changes, stating that the proposed change would be duplicative with 10 CFR part 50 QAP requirements. The NRC disagrees with this comment because if a 10 CFR part 50 licensee uses its 10 CFR part 50 QAP for 10 CFR part 71 activities, the QAP reporting requirements in 10 CFR part 50 would be controlling and 10 CFR part 71 QAP reporting requirements would not apply. Also, the NRC notes that many users of 10 CFR part 71 do not have 10 CFR part 50 licenses, and the 10 CFR part 71 QAP change provisions would not be duplicative for them.

The NRC received a comment on Issue 15 on the advance notification requirements in § 71.97, stating that there is no actual provision requiring advance notification for spent fuel shipments. The requirements in § 71.97 currently contain reporting requirements that are duplicative with those in 10 CFR part 73, and the NRC is proposing to delete the duplicative language.

Because none of the comments would result in significant changes to the draft regulatory basis, the NRC considered these comments in preparing this proposed rule and did not issue a final regulatory basis.

The NRC is proposing to amend its regulations to harmonize them with the IAEA international transportation standard No. SSR-6 (2018 Edition). These revisions would be coordinated with DOT and its hazardous materials regulations to maintain a consistent framework for the domestic transportation and packaging of radioactive material.

This proposed rule also would revise 10 CFR part 71 to include administrative, editorial, or clarifying changes, including changes to certain Agreement State compatibility category designations that are further discussed in Section XV, “Compatibility of Agreement State Regulations,” of this document.

This action would affect (1) NRC licensees authorized by a Commission-issued specific or general license to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, or transports the material outside of the site of usage as specified in the NRC license, or transports that material on public highways; (2) holders of, and applicants for, a certificate of compliance (CoC) under 10 CFR part 71; and (3) holders of a 10 CFR part 71 QAP approval. This action also would change requirements that are a matter of compatibility with the Agreement States. Therefore, the Agreement States would need to update their regulations, as appropriate, at which time those licensees in Agreement States would need to meet the compatible Agreement State regulations.

The NRC is proposing to revise 10 CFR part 71 as described in the 15 issues listed in this document and summarized in the following table (note that the issue numbers described in Section III.C of this document are consistent with those described in the regulatory basis):

The fissile material exemptions in § 71.15 and the fissile material general licenses in §§ 71.22 and 71.23 allow licensees to ship low-risk fissile material ( e.g., small quantities or low concentrations) without meeting the fissile material packaging requirements and criticality safety assessments, as specified in §§ 71.55 and 71.59, and without obtaining prior NRC approval. For these low-risk fissile material shipments, the fissile material exemptions and general licenses provide reasonable assurance that criticality safety is afforded under normal conditions of transport and hypothetical accident conditions. In 2012, IAEA modified the fissile exception provisions in SSR-6, paragraph 417, to include three new per-package mass limit options, with associated mass limits on the consignment and/or conveyance.

The NRC proposes to incorporate two additional fissile exemptions under § 71.15. This proposed rule would adopt the exception in SSR-6, paragraph 417(c), without the associated consignment limit of IAEA SSR-6, paragraph 570(c). This proposed rule would also adopt the exception in SSR-6, paragraph 417(e), with its associated exclusive use restriction in paragraph 570(e), but with a higher mass limit.

Since the amount of fissile material allowed by SSR-6, paragraph 417(c), is similar to the existing exemption in § 71.15(a), in terms of reactivity, the NRC determined that the consignment limit of IAEA SSR-6, paragraph 570(c), is not necessary. Consignment limits, as provided in 570(c), do not prevent the accumulation of packages on a transport conveyance, as there is no limit to the number of consignments that may be present on a single conveyance. Additionally, the number of these packages does not need to be limited by regulation because reaching the amount required to approach criticality on a single conveyance is not credible.

The NRC has determined that a mass value higher than that contained in IAEA SSR-6, paragraph 417(e), is justified, given the conservatism inherent in the exclusive use restriction of the SSR-6 provision, and in basing the mass limit on plutonium-239 ( 239 Pu), which would have to be shipped in a Type B package. The NRC proposes a limit of 140 grams of fissile material on a conveyance shipped under exclusive use, as another exemption under § 71.15. This limit is based on one fifth of a minimum critical mass of uranium-235 ( 235 U) (as defined in American National Standards Institute/American Nuclear Society [ANSI/ANS] 8.1-2014 (Reaffirmed 2018), “Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors”) under optimum conditions. This mass represents a conservative limit for fissile material, since five times this amount would remain subcritical under any condition. Additionally, the limit provides safety equivalent to packages approved under 10 CFR part 71 and could provide more flexibility for shipping individual contaminated items or small quantities of fissile material. The NRC considers 235 U for this limit rather than 239 Pu, as any amount of 239 Pu over 0.435 grams is considered Type B, which would have to be packaged to withstand both normal and hypothetical accident conditions of transport. Although the NRC proposed value is different from the IAEA SSR-6, paragraph 417(e), value, the NRC determined that the higher value is technically justified and will be appropriate for NRC licensees who ship specific waste streams ( e.g., decommissioning waste), and that there will be little international shipment from the United States of this type of material. Licensees who ship material internationally must comply with DOT requirements for the use of international standards in title 49, “Transportation,” of the CFR.

Additionally, the NRC is not proposing to adopt the “packaged or unpackaged” language in the fissile exception provision of IAEA SSR-6, paragraph 417(e). The 140-gram limit, as with other fissile exemption provisions in § 71.15, only relieves the consignor from having to ship in a “Fissile” package, evaluated per the requirements of §§ 71.55 and 71.59. This material is still subject to all other radioactive materials transportation requirements in 10 CFR part 71 and in 49 CFR part 173 and should be packaged accordingly. The NRC is proposing to make a minor change to § 71.15(d) for clarity and to maintain consistent language throughout § 71.15.

The regulation at § 71.71(c)(3) requires Type AF and Type B package designs to be able to withstand a reduction in external pressure to 25 kilopascals (kPa) (3.6 psia) under normal conditions of transport. For a Type A package (as defined in SSR-6, paragraphs 231 and 429; 10 CFR 71.4, “Definitions”; or 49 CFR 173.403, “Definitions”), IAEA SSR-6, paragraph 645, states that “[t]he containment system shall retain its radioactive contents under a reduction of ambient pressure to 60 kPa.” This requirement also applies to Type B(U) and Type B(M) packages, in accordance with SSR-6, paragraphs 652 and 667, respectively. Additionally, IAEA SSR-6, paragraph 621, indicates packages containing radioactive material to be transported by air shall be capable of withstanding, without loss or dispersal of the radioactive contents from the containment system, an internal pressure that produces a pressure differential of not less than maximum normal operating pressure plus 95 kPa (13.8 psi).

In a final rule published by the DOT (79 FR 40589; July 11, 2014), the DOT harmonized its regulations in 49 CFR chapter I to the 2009 Edition of IAEA TS-R-1. In that final rule, the DOT explained that a Type A package must be designed to ensure the package can retain its contents under the reduction of ambient pressure. That ambient pressure value, found at 49 CFR 173.412(f), was changed from 25 kPa (3.6 psia) to 60 kPa (8.7 psia).

The NRC considered whether it should change the reduced external pressure test requirement in § 71.71(c)(3) to harmonize with the IAEA transport standards and to be consistent with the DOT regulations for design requirements for Type A packages. The NRC assessed the potential impacts of the change in the external pressure value from 25 kPa (3.6 psia) to 60 kPa (8.7 psia) and the additional air transport requirements from SSR-6, paragraph 621. The current NRC reduced external pressure test requirement, 25 kPa (3.6 psia), equates to an altitude of about 35,000 feet (10,668 meters) above sea level, which is an appropriate altitude for air transport of packages. Since cargo planes use pressurized cargo holds during air transport, this external pressure value also represents the ambient pressure on a package should the cargo hold depressurize. Whereas the 60 kPa (8.7 psia) value equates to an altitude of about 14,040 feet (4,279 meters) above sea level. Thus, while the 60 kPa (8.7 psia) external pressure value equates well with the highest paved road in the United States (14,130 feet (4,307 meters)) and with the elevation of the highest operating freight railroad in the United States (La Veta Pass at 9,242 feet (2,817 meters)), it would not support air transport conditions, as cargo planes operate at higher altitudes. When comparing the current 25 kPa (3.6 psia) value with the proposed 60 kPa (8.7 psia) value, and the associated altitudes, the NRC determined that no change to § 71.71(c)(3) is needed, and the 25 kPa (3.6 psia) value should be retained.

The NRC also considered adding the air transport requirements from SSR-6, paragraph 621. However, other than specific air transport requirements at § 71.55(f), “General requirements for fissile material packages” and § 71.88, “Air transport of plutonium,” 10 CFR part 71 does not contain “mode-specific” regulations. Because the existing reduced external pressure test value covers air transport conditions as discussed above, and because of the robustness of Type AF and Type B packages, as compared to Type A packages, the NRC finds it unnecessary to add the mode-specific air transport requirements from SSR-6, paragraph 621, into 10 CFR part 71.

Based on the above considerations and assessments, the NRC has decided not to pursue any changes to § 71.71(c)(3). As a result, no further discussion or analysis is presented in this proposed rule on the reduced external pressure test for normal conditions of transport.

In the 2004 final rule, the NRC did not adopt the regulations for Type C packages contained in IAEA TS-R-1. The NRC did not adopt them because 1) §§ 71.64 and 71.74 for plutonium air transportation contain more rigorous packaging standards, 2) the NRC perceived no need (current or anticipated) for such packages, and 3) if a need arose for import or export, it could be accomplished through the DOT regulations.

In the request for comment on the issues paper, the NRC asked stakeholders whether there was a need for domestic transport of Type C packages. No NRC licensees expressed a need for domestic transport of Type C packages. Therefore, the NRC has decided not to pursue further changes to Type C package standards as contemplated in the regulatory basis document. As a result, no further discussion or analysis is presented in this proposed rule on that issue.

During transport, a package is subjected to heating by the sun, called insolation. The effect of insolation is an increase in the package temperature. The NRC is proposing to change the unit of measure for the values of insolation used for the heat test for normal conditions of transport in § 71.71(c)(1), and to add insolation to the initial conditions for the tests for hypothetical accident conditions in § 71.73(b).

The units for insolation in 10 CFR part 71 are gram calories per square centimeter (g cal/cm 2 ). When the IAEA published Safety Series No. 6, “Regulations for the Safe Transport of Radioactive Material, 1985 Edition,” it revised the units used for insolation for normal conditions of transport from a hybrid of English and metric units (g cal/cm 2 ) to metric units (watts per square meter (W/m 2 )). When the IAEA changed the units, it chose to keep the same numerical values, thus increasing the evaluated solar heat load on a package by approximately 3 percent. The IAEA did not provide a technical rationale for this change; however, the NRC observes that retaining the existing numerical quantities maintains simple (round) values in the regulations that result in a small change in solar heat load.

The NRC previously harmonized its regulations with the 1985 Edition of Safety Series No. 6 (60 FR 50248; September 28, 1995). That final rule neither discussed nor proposed changing the units on the heat test for normal conditions of transport in § 71.71(c)(1). Consequently, the current units for insolation in 10 CFR part 71 are “g cal/cm 2 .” This is inconsistent with IAEA standards in the 2018 Edition of SSR-6. As a result, NRC package approvals are evaluated for less insolation than that prescribed by IAEA standards and evaluated for approval by foreign competent authorities.

The NRC is proposing to revise the units of insolation for the heat test for normal conditions of transport in § 71.71(c)(1) to match the units used in the 2018 Edition of SSR-6 to ensure that NRC requirements for insolation are consistent with the IAEA standard. Consistent with Issue 10, “Transitional Arrangements,” the NRC would not expect a certificate holder to evaluate the higher solar heat load unless it requests a revision of its certificate to show compliance with the revised transportation regulations in 10 CFR part 71. Additionally, given the small increase in insolation due to the revised units, the NRC expects that certificate holders will be able to show compliance with the package approval standards in subpart E, “Package Approval Standards,” to 10 CFR part 71.

In Safety Series No. 6, “Regulations for the Safe Transport of Radioactive Material, 1985 Edition (As Amended 1990),” paragraph 628 stated, “With respect to the initial conditions for the thermal test, the demonstration of compliance shall be based upon the assumption that the package is in equilibrium at an ambient temperature of 38 °C. The effects of solar radiation may be neglected prior to and during the tests, but must be taken into account in the subsequent evaluation of the package response.”

The thermal test, previously in paragraph 628, was moved to paragraph 728 in the 1996 Edition of TS-R-1 and revised to state, “The specimen shall be in thermal equilibrium under conditions of an ambient temperature of 38 °C, subject to the solar insolation conditions specified in Table XI and subject to the design maximum rate of internal heat generation within the package from the radioactive contents.”

When the NRC revised its regulations in 2004 to harmonize with the 1996 IAEA standards (69 FR 3697; January 26, 2004), the NRC did not revise the initial conditions of the fire test listed in § 71.73(b) to require evaluation of insolation as an initial condition.

Since a fire can occur on a hot, sunny day, and to be consistent with IAEA standards, the NRC is proposing to revise the initial conditions in § 71.73(b) to require insolation as an initial condition for all the tests for hypothetical accident conditions. Consistent with Issue 10, “Transitional Arrangements,” the NRC would expect a certificate holder to evaluate the revised initial conditions in § 71.73 if it wants to revise its certificate to show compliance with the revised transportation regulations in 10 CFR part 71.

The term “radiation level” was first introduced in the IAEA transport standards in Safety Series No. 6, 1973 Edition, and it was defined in terms of “dose-equivalent rate” as “the corresponding radiation dose-equivalent rate expressed in millirem per hour.” External radiation standards were defined in terms of radiation levels in each subsequent edition of the IAEA's transport standards, including the 2012 Edition of SSR-6. In the 2018 Edition of SSR-6, the IAEA replaced the term “radiation level” with the term “dose rate” and defined the dose rate to be the dose-equivalent per unit time. Because the current regulations in 10 CFR part 71 use the term “radiation level,” the NRC is concerned that using a different term from the IAEA to define external radiation standards could create some confusion with respect to international shipments.

Additionally, NRC regulations in 10 CFR part 20, “Standards for Protection Against Radiation,” include a definition for “dose equivalent” in § 20.1003 that means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv).

The NRC considered replacing the term “radiation level” used throughout 10 CFR part 71 with “dose equivalent rate.” However, this change would result in cost impacts to licensees to change documentation and training programs with no safety benefit. Therefore, in order to minimize the burden to licensees, the NRC is proposing to add a definition to § 71.4 that clarifies that “radiation level” means “dose equivalent rate,” which enables the NRC to continue using “radiation level” throughout 10 CFR part 71. The NRC is not expecting any licensee to change its documentation to account for this new definition.

The definition for “Low Specific Activity (LSA) material” in § 71.4 includes three categories of material: LSA-I, LSA-II, and LSA-III. Radioactive material, low specific activity category III ( i.e., LSA-III) includes solids, excluding powders, that meet the requirements in § 71.77, “Qualification of LSA-III material” and which have an estimated average specific activity limit that does not exceed 2 × 10 −3 times the A 2 value per gram (A 2 /g). The qualification tests in § 71.77 include a leaching test with immersion of the specimen material for 7 days. The IAEA eliminated the LSA-III leaching test in SSR-6, 2018 Edition, from paragraphs 409, 601, and 701. Consequently, the NRC is proposing corresponding revisions to §§ 71.4, 71.77, and 71.100, “Criminal penalties,” to remove the leaching test and its references.

In April 2015, an international working group meeting was conducted to discuss issues related to LSA-II and LSA-III material, with special attention on the need for the LSA-III leaching test. The need for the leaching test was questioned because the working group determined that the test has no bearing on the inhalation risk of exposure to material during transport. The inhalation risk is used to determine the average specific activity limits for both LSA-II and LSA-III material, which are 10 −4 A 2 /g and 2 × 10 −3 A 2 /g, respectively. Related investigations dating back to 2003 revealed that the amount of released radioactive material leading to an inhalation dose under the mechanical tests for normal conditions of transport greatly depend on the physical form of the LSA material. The primary difference between LSA-II and LSA-III materials is that LSA-III is limited to solid material, excluding powders. Due to the solid nature of the LSA-III material, the amount of airborne radioactivity released during the mechanical tests for normal conditions of transport leading to an inhalation dose is at least a factor of 100 lower for LSA-III solids than for LSA-II solids in powder form. This much lower airborne release for LSA-III material due to its non-readily dispersible form outweighs the difference in average specific activity limit, which is 20 times greater for LSA-III compared to LSA-II material in powder form. Because of the non-dispersible form of the LSA-III material, the working group determined that there was no need to take credit from a leaching test to justify this allowable 20-fold increase in average specific activity between LSA-III and LSA-II material.

The NRC recognizes the working group's information, and is recommending harmonization with SSR-6, 2018 Edition, and removal of the leaching test from 10 CFR part 71. The NRC agrees that requiring the LSA-III leaching test does not increase the safety of the material during transport. Further, the test does not decrease the inhalation pathway exposure when compared to LSA-II material in powder form, and therefore should be removed from 10 CFR part 71. The NRC considered the information provided by the LSA-II and LSA-III working groups and comments received on this issue during the comment period on the NRC's issues paper. Additionally, the NRC considers that removal of the leaching test also would reduce regulatory burden for shippers, while still maintaining reasonable assurance of safety for transport of LSA-III material.

The NRC is proposing to remove the leaching test in § 71.77 and make conforming changes to §§ 71.4 and 71.100, which both reference § 71.77.

As more nuclear facilities begin decommissioning activities, there will be an increase in the number of shipments of radioactive materials from these facilities. Decommissioning activities can include transporting large radioactive objects ( e.g., steam generators, coolant pumps, and pressurizers). Under current NRC regulations, shipment of such large, nonstandard packages that do not meet the existing definition of surface contaminated objects ( i.e., either SCO-I or SCO-II, as defined in § 71.4) could be addressed through a special package authorization under § 71.41(d). However, such an authorization may take significant time. The NRC proposes to add a regulatory definition for SCO-III to include these types of objects, allowing a shipper to more appropriately categorize the item it is planning to transport. The NRC anticipates an increase in efficiency for both the NRC and licensees when the SCO-III definition is included in 10 CFR part 71 when compared to the special package authorization review needed under § 71.41(d). Harmonization with SSR-6, 2018 Edition, would add the new SCO-III category and the associated definition.

In the 2004 final rule (69 FR 3697; January 26, 2004), the NRC determined that special package authorizations were necessary because there were no regulatory provisions in 10 CFR part 71 concerning large, nonstandard packages considered for transportation. Therefore, the NRC added paragraph (d) to § 71.41. Since that time, the NRC has gained experience with the safety aspects of shipping these types of large, non-standard packages. For example, in 2006, the LaCrosse reactor vessel was the first shipment in which a package was approved under § 71.41(d). In addition, a special package authorization was issued for the West Valley Melter Package from the West Valley Demonstration Project. In the future, a licensee shipping large radioactive objects that have been determined to meet the definition of SCO-III would not need NRC review and approval for a special package authorization.

Both the NRC and DOT intend to add a definition for SCO-III. The NRC is coordinating with the DOT to align its definition with the DOT's, since the DOT is the lead agency for review and evaluation of both LSA and SCO material.

In the 2004 final rule (69 FR 3697; January 26, 2004), the NRC harmonized its regulations with the 1996 Edition of IAEA TS-R-1. In that final rule, the NRC added a new provision, § 71.55(g), to provide a specific exception for certain uranium hexafluoride (UF 6 ) packages from the requirements of § 71.55(b). The exception allows UF 6 packages to be evaluated for criticality safety without considering inleakage of water into the containment system, provided certain conditions are met, including that the uranium is enriched to not more than 5 weight percent in 235 U. To use this exception, the applicant must demonstrate, among other things, that, following the tests for hypothetical accident conditions in § 71.73, there is no physical contact between the valve body and any other component of the packaging, other than at its original point of attachment, and the valve remains leak tight. “Leaktight” is defined in ANSI N14.5-2014, “American National Standard for Radioactive Materials—Leakage Tests on Packages for Shipment,” as “[t]he degree of package containment that, in a practical sense, precludes any significant release of radioactive materials. This degree of containment is achieved by demonstration of a leakage rate less than or equal to 1 × 10 −7 ref·cm 3 /s, of air at an upstream pressure of 1 atmosphere (atm) absolute (abs), and a downstream pressure of 0.01 atm abs or less.”

The NRC provided the specific exception: (1) to be consistent with the worldwide practice and limits established in national and international standards (ANSI N14.1-2012, “Nuclear Materials—Uranium Hexafluoride—Packagings for Transport,” and International Organization for Standardization 7195, “Packaging of Uranium Hexafluoride (UF 6 ) for Transport”) and DOT regulations (49 CFR 173.417(b)(5)); (2) because of the history of safe shipment; and (3) because of the essential need to transport the commodity. In that final rule, the NRC codified its long-standing practice to not consider water inleakage into UF 6 packages as long as the documentation of the results of the tests for hypothetical accident conditions tests at § 71.73 show that the cylinder valve was not affected.

In SSR-6, 2018 Edition, the IAEA added the same standard for the plug as was added in the 1996 Edition of TS-R-1 for the valve to ensure that the entire cylinder remains leak tight. The revised paragraph 680(b)(i), SSR-6, 2018 Edition, states: “Packages where, following the tests prescribed in para. 685(b), there is no physical contact between the valve or the plug and any other component of the packaging other than at its original point of attachment and where, in addition, following the test prescribed in para. 728, the valve and the plug remain leaktight.”

The 30-inch UF 6 cylinder, the most commonly used cylinder to transport large quantities of enriched UF 6 for the fuel fabrication industry, has two penetrations: one for the valve at the top to fill the cylinder and one for the drain plug at the bottom used during maintenance. In order to ensure criticality safety, both the plug and the valve must remain leak tight after the tests for hypothetical accident conditions to prevent ingress of water into the cylinder. While this may be a new requirement in transportation regulations, during package approval, the NRC has always verified that the entire 30B cylinder remained leak tight after the tests for hypothetical accident conditions.

The NRC is proposing to revise § 71.55(g)(1) to require that there is no contact between the cylinder plug and any other part of the packaging, other than at its original attachment point and that the cylinder plug remains leak tight, as NRC requires for the cylinder valve.

The NRC regulations do not explicitly require that a package application include an evaluation of aging mechanisms and a maintenance program. Rather, applicants include an evaluation of aging effects on package components to ensure there is no significant degradation in accordance with § 71.43(d). The NRC regulations at § 71.43(d) require that packages be made of materials and construction that assure that there will be no significant chemical, galvanic, or other reaction (including effects of irradiation from the package contents) among the packaging components, among package contents, or between the packaging components and the package contents, including possible reaction resulting from inleakage of water, to the maximum credible extent.

For those components where aging is detrimental to package performance, applicants provide a description of the maintenance program, including periodic testing to evaluate the components' efficacy and/or a replacement or repair schedule, to mitigate those detrimental effects. The NRC requires that licensees and CoC holders follow the maintenance program, which is provided in the application for approval, as a condition of approval in the CoC. Additionally, NRC regulations at § 71.87(b) require that, prior to each shipment, the licensee ensures that the package is in unimpaired physical condition except for superficial defects such as marks or dents. Meeting this regulation, along with the scheduled periodic tests and replacement/repair in the maintenance program, should identify package deterioration prior to age-related degradation becoming a safety issue during transport.

In paragraph 613A, SSR-6, 2018 Edition, the IAEA added that package design evaluations must consider aging mechanisms. In paragraph 809, SSR-6, 2018 Edition, the IAEA added that the application for package approval must contain a maintenance program. Because an evaluation of aging effects and a description of the maintenance program are not specifically required by 10 CFR part 71, the NRC is proposing to revise § 71.43(d) to specifically include the evaluation of the effects of aging, and add a new provision to subpart D, “Application for Package Approval,” to include a description of the maintenance program in an application for package approval, to better align with these standards in SSR-6, 2018 Edition.

Historically, IAEA standards and DOT and NRC regulations have included transitional arrangements when the regulations have undergone revision. The purpose is to minimize the costs and impacts of implementing changes in the regulations, since package designs and special form sources that are compliant with the existing regulations do not become unsafe when the regulations are revised (unless a significant safety issue is corrected in the revision).

Typically, the transitional arrangements include provisions that allow for (1) continued use of existing package designs and packagings already fabricated; and completion of packagings in the process of being fabricated, although some restrictions on fabrication of packagings approved to earlier editions of the regulations may be imposed; (2) restriction on modifications to package designs without the need to demonstrate full compliance with the revised regulations; (3) changes in packaging identification numbers; and (4) changes to the fabrication and use of special form sources approved to earlier versions of the regulations.

The NRC CoCs include a package identification number which identifies the NRC regulations and the corresponding version of IAEA standards to which the package was approved. For example, packages with a “-85” in the package identification number were approved to NRC regulations compatible with the provisions of the 1985 or 1985 (as amended 1990) Editions of Safety Series No. 6. NRC packages with a “-96” in the package identification number were approved to NRC regulations compatible with the 1996 Edition of TS-R-1.

The IAEA updated its transitional arrangements in paragraphs 819-823, SSR-6, 2018 Edition, for packages that have a “-85” or “-96” in their package identification number. However, it does not include transitional arrangements for package designs approved under the IAEA's 1973 Edition of Safety Series No. 6, “Regulations for the Safe Transport of Radioactive Materials.” The NRC previously harmonized its requirements with the 1973 Edition; corresponding packages are those for which the CoC does not have a year designation in the package identification number. By not including transitional arrangements on these packages, the IAEA standards effectively phase out the use of these packages approved under the 1973 Edition of Safety Series No. 6.

The IAEA's SSR-6, 2018 Edition, also prohibits, after December 31, 2028, the fabrication of new packagings that have not been shown to meet SSR-6, 2018 Edition standards. This means that package designs approved to earlier versions of IAEA standards ( i.e., NRC-approved packages for which the CoC has a “-96” in its package identification number), could not be used unless fabrication is completed before January 1, 2029. Note that IAEA standards and NRC regulations already prohibit the use of packages that have “-85” in their package identification number on the CoC if their fabrication was not completed by December 31, 2006.

The IAEA's SSR-6, 2018 Edition, also phases out certain special form radioactive material. The NRC regulations contain a definition of, and the tests for, special form radioactive material. Special form radioactive material is either a non-dispersible solid or sealed in a capsule so that the dispersibility, and therefore the radiological hazard, of the radioactive material is diminished. In order to be designated as special form, the radioactive material must be evaluated using the tests and acceptance criteria in § 71.75.

Paragraph 823 of SSR-6, 2018 Edition, does not include provisions for use of special form radioactive material approved under 1973 Edition of Safety Series No. 6. In SSR-6, 2018 Edition, special form radioactive material that was shown to meet the provisions of the 1985 through 2012 Editions of IAEA standards may continue to be used, with some additional restrictions on approval and fabrication. The IAEA's SSR-6, 2018 Edition, prohibits fabrication of special form radioactive material that received unilateral approval under the 1985 Edition of Safety Series No. 6 or 1985 (as Amended 1990) Edition of Safety Series No. 6. Also, after December 31, 2025, IAEA standards prohibit new fabrication of special form radioactive material sources to a design that had received unilateral approval under the 1996 Edition; 1996 Edition (Revised); 1996 (as Amended 2003) Edition of TS-R-1; TS-R-1, 2005 Edition; TS-R-1, 2009 Edition; and SSR-6, 2012 Edition.

Finally, in paragraphs 832-833, SSR-6, 2018 Edition, the IAEA revised the package identification number in the CoC to delete the year designation ( i.e., “-85” or “-96”) for those package designs that are approved to SSR-6, 2018 Edition.

In the 2004 final rule (69 FR 3698; January 26, 2004), the NRC adopted the following grandfathering provisions in § 71.19 for previously-approved packages:

• Packages approved under NRC regulations that were compatible with the provisions of the 1967 Edition of Safety Series No. 6 may be used for a 4-year period after adoption of the final rule, presuming fabrication was completed by August 31, 1986;

• Packages approved under NRC regulations that became effective on September 6, 1983 (see 48 FR 35600; August 5, 1983), which are compatible with the provisions of the 1973 or 1973 (as amended) Editions of Safety Series No. 6, may no longer be fabricated, but may still be used;

• Packages approved under NRC regulations that are compatible with the provisions of the 1985 or 1985 (as amended 1990) Editions of Safety Series No. 6, and designated as “-85” in the package identification number, may not be fabricated after December 31, 2006, but may still be used; and

• Package designs approved under any pre-1996 IAEA standards ( i.e., NRC packages with an “-85” or earlier package identification number) may be resubmitted to the NRC for review against the current NRC regulations. If the package design described in the resubmitted application meets the current NRC regulations, the NRC may issue a new CoC for that package design with a “-96” designation in the package identification number.

In that same 2004 rulemaking, the NRC did not revise its grandfathering provisions on special form radioactive material in § 71.4 because NRC regulations were already consistent with the 1996 Edition of TS-R-1.

The NRC rulemaking in 2015 (80 FR 33988; June 12, 2015) made two minor changes to the transitional arrangements regulations. First, the grandfathering provision that was in § 71.19(a) for packages approved under NRC standards that were compatible with the provisions of the 1967 Edition of Safety Series No. 6 was deleted since that provision expired on October 1, 2008. Second, the definition of “special form radioactive material” was revised to allow special form radioactive material that was successfully tested using the current requirements of § 71.75(d) to continue to qualify as special form radioactive material, if the testing was completed before September 10, 2015.

Consistent with past practices, the NRC is proposing transitional arrangements to phase out older packages without a “-85” or “-96” in the package identification number, and limit use of packages with a “-96” to those whose fabrication has been completed by December 31, 2028, and consistent with DOT, limit fabrication of special form sources. The NRC determined that it is appropriate to begin a phased discontinuance of these older packages to further harmonize NRC's regulations with the IAEA standards in SSR-6, 2018 Edition. The DOT supports this discontinuation and coordinated with the IAEA on the update to its standards. While the NRC has not identified safety issues that necessitate the discontinuation of these older packages, they are no longer acceptable in jurisdictions that use the IAEA requirements. The NRC views that the advantages of consistent approvals across jurisdictions outweigh the value of retaining the authorization for these packages. The approach being taken is consistent with the NRC's 2004 rulemaking. Given this experience, the NRC does not expect that certificate holders will have challenges showing compliance with the regulations in effect at the time the application is submitted for revision.

The NRC is proposing to revise its transitional arrangements to be consistent with the IAEA, as follows:

1. Phase out the use of packages approved to NRC regulations that were harmonized with the IAEA's 1973 Edition and 1973 (as Amended) Edition of Safety Series No. 6, 8 years after the effective date of this rulemaking. These packages would be required to be recertified, removed from service, or used via exemption.

2. Prohibit the use of packages with a “-96” in the package identification number for which fabrication of the packaging was completed after December 31, 2028, and require multilateral approval (as defined in 49 CFR 173.403, “Definitions”) for packages to be used for international shipment after December 31, 2025. Revise § 71.17(e) to state that packages with a “-96” in the package identification number would become previously approved packages and subject to the current § 71.19(c).

3. Coordinate with the DOT and make appropriate changes to § 71.4 to align with the definition of “special form radioactive material” that the DOT is proposing to adopt as part of their harmonization rulemaking, since DOT is the lead for certifying special form sources. The NRC is proposing to allow continued use of special form radioactive material that was approved to the regulations in effect from October 1, 2004 to the effective date of this rulemaking, provided they are fabricated on or before December 31, 2025.

4. Allow for package designs with a “-96” or earlier package identification number to be resubmitted to the NRC for review against the current standards. If the package design described in the resubmitted application meets the current standards, the NRC may issue a new CoC for that package design without a year designation.

The NRC notes that the IAEA eliminated the approval year in the package identification number for packages approved to SSR-6, 2018 Edition. Packages that were approved to NRC regulations harmonized with the 1973 Edition of Safety Series No. 6 do not have a year designation in the package identification number. To avoid confusion regarding these older packages, the NRC would revise all existing CoCs that do not have a “-85” or “-96” in their package identification number to add a provision that those CoCs cannot be renewed beyond the end date of the 8-year phase out period without being recertified to the revised version of 10 CFR part 71.

The NRC's regulation in § 71.87, “Routine determinations,” requires that before each shipment of licensed material, the licensee must ensure that the package, which includes its contents, satisfies the applicable requirements of part 71. One such requirement is that the licensee must determine in accordance with § 71.87(d) that any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid.

The NRC's requirement in § 71.87(d) is compatible with the DOT's regulations at 49 CFR 173.24(h)(1), “General requirements for packagings and packages.” That regulation requires: “When filling packagings and receptacles for liquids, sufficient ullage (outage) must be left to ensure that neither leakage nor permanent distortion of the packaging or receptacle will occur as a result of an expansion of the liquid caused by temperatures likely to be encountered during transportation.”

The DOT's regulations in 49 CFR 173.412(k), “Additional design requirements for Type A packages,” contain a general design requirement for Type A packages designed to contain liquids to ensure that packages provide for ullage to accommodate variations in temperature of the contents. The term “ullage” refers to the unfilled space in a container, or the amount by which the contents of a container fall short of being full. Because DOT's regulations for Type AF, Type B, and Type BF packages refer to the NRC's regulations, DOT's regulations do not contain design requirements for Type AF, Type B, or Type BF packages. Type A, Type AF, Type B, and Type BF packages are defined in § 71.4, “Packages.”

The IAEA standards in paragraph 649, SSR-6, 2018 Edition, require that “The design of a package intended for liquid radioactive material shall make provision for ullage to accommodate variations in the temperature of the contents, dynamic effects and filling dynamics.”

The NRC regulations have an operational requirement in § 71.87(d) to ensure that for a system containing liquid, there is sufficient head space, or other specified provision to accommodate the expansion of liquid. The NRC does not, however, have a comparable design requirement for Type AF and Type B packages in 10 CFR part 71 to that in DOT's regulations. Even though the NRC's regulations do not include a comparable design requirement for ensuring sufficient space to allow for liquid expansion, any Type AF or Type B package design certified by the NRC must comply with § 71.87 and DOT regulations in 49 CFR 173.24(h) on ullage when being filled.

During review of applications for either a new CoC or an amendment to an existing CoC, the NRC reviews whether the requirements in § 71.87(d) are reflected in the operating procedures for packages with liquid contents. Each package approval issued by the NRC contains a condition to ensure that the package is prepared in accordance with the operating procedures in the application. This ensures that all package users, whether NRC licensees or not, comply with the requirements listed in § 71.87, as appropriate for the package design.

Although the NRC regulations ensure that adequate ullage exists, the NRC has received on occasion an application that did not evaluate whether there was sufficient design space in a container with liquids. To clarify this requirement, the NRC is proposing to revise § 71.43, “General standards for all packages,” to add a design requirement for a package designed to contain liquids to ensure adequate ullage during evaluation of the tests and conditions for normal conditions of transport and hypothetical accident conditions.

On June 12, 2015, the NRC issued a final rule (80 FR 33988), updating the administrative procedures for the QAP requirements described in 10 CFR part 71, subpart H, “Quality Assurance.” Specifically, the NRC added § 71.106 to establish requirements for QAP changes and associated reporting requirements.

Previously, all changes made to QAP approvals had to be reviewed and approved by the NRC before they could be implemented. The provisions in § 71.106 allow changes to QAPs that do not reduce commitments, such as those that involve administrative improvements and clarifications, spelling corrections, and non-substantive changes, to be made and implemented without prior NRC approval. QAP changes that would reduce commitments require prior NRC approval.

In addition, § 71.106 requires that changes to QAPs that do not reduce commitments must be submitted to the NRC every 24 months. That final rule also specified, “If a quality assurance program approval holder has not made any changes to its approved quality assurance program description during the preceding 24-month period, the approval holder will be required to report this to the NRC” (80 FR 33994). In addition, the NRC's guidance document for 10 CFR part 71 QAPs, Regulatory Guide 7.10, Revision 3, was updated in conjunction with the 2015 final rule to state that if no changes were made to the QAP, a QAP approval holder would indicate to the NRC that no changes were made.

The requirement for a report, even if no changes were made during the preceding 24-month period, is necessary as the NRC inspection program for 10 CFR part 71 QAP approval holders relies on having current information about the QAP available to the NRC. The NRC considers the 24-month reporting requirement, including when no changes are made, as providing an appropriate balance between the burden placed on the QAP approval holders and the need to ensure that the NRC has current information for its oversight of these QAPs. Most QAP approval holders subject to periodic inspection are inspected every 5 years or on an as-needed basis. Another benefit to receiving a report even when no QAP changes have been made is that the QAP reporting requirements in 10 CFR part 71 would be consistent with those in §§ 50.54(a)(3) and 50.71(e)(2) for 10 CFR part 50 QAPs. Since the 2015 final rule became effective, the NRC has received questions and concerns from industry on this subject since the language in § 71.106 does not state that QAP approval holders must report even if there were no changes in the prior 24-month period.

The NRC is proposing to revise § 71.106(b) to clarify that a biennial report must be submitted to the NRC even if no changes are made to the QAP during the reporting period.

The general license criteria in § 71.22 allow NRC licensees to ship small quantities of fissile material in packages that have been assigned a criticality safety index (CSI) to ensure accumulation control for packages on a conveyance. The provisions of § 71.22 require that (1) the fissile material is in a Type A package that meets the requirements of 49 CFR 173.417(a); (2) licensees have an NRC-approved QAP satisfying the provisions of 10 CFR part 71, subpart H; (3) there is no more than a Type A quantity of radioactive material; (4) there is less than 500 grams total of beryllium, graphite, or hydrogenous material enriched in deuterium; and (5) the package is labeled with a CSI that meets the limits in § 71.22(d). The regulation in § 71.22(e)(1) provides an equation to calculate package CSI:

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

The calculations that support the mass limits in § 71.22 include conservative assumptions regarding neutron moderation and water reflection, i.e., optimally moderated spheres of 235 U, 233 U, and 239 Pu with full water reflection. The mass limits in § 71.23 have a similar basis, but are higher for the two fissile plutonium isotopes, as the material is special form and will not redistribute significantly. In both cases, it is assumed that the material will remain in the package under normal conditions of transport because of the Type A package requirement but can reconfigure outside of the package under hypothetical accident conditions. The limitation to a Type A quantity of radioactive material in a Type A package, however, is not consistent with the mass limits for some fissile nuclides in some cases ( e.g., the mass limits for 239 Pu in Table 71-1 are 37 grams or 24 grams, depending on the degree of moderation, while the A 2 value for 239 Pu is equivalent to 0.435 grams). In addition, the requirement in § 71.23 does not consistently refer to “special form sealed sources” in that paragraph (a) also refers to Pu-Be sealed sources. While all special form sources are sealed sources, not all sealed sources meet the definition of special form material in 10 CFR 71.4.

Removing the limitation to a Type A quantity of radioactive material in a Type A package would allow licensees to ship material under the general licenses in §§ 71.22 and 71.23 in a Type B package. When shipping material that meets the mass limits of the general licenses in §§ 71.22 and 71.23 in a Type B package, the criticality safety conclusions associated with these mass limits remain valid. In fact, the material would be less likely to present a criticality hazard, as Type B packages generally are more robust and have more mass, which would increase neutron absorption, limit releases under hypothetical accident conditions, and prevent material from multiple packages from redistributing together under optimum moderation conditions.

Revising the general licenses to authorize transport in a Type B package would also require conforming changes to § 71.0(d)(1). The regulations in § 71.0(d)(1) state that use of the general licenses in § 71.22 or § 71.23 does not require NRC approval. Package approval is not currently required by the NRC because the conditions of the general licenses require the contents to be in a Type A package. The regulations in § 71.14(b)(1) exempt the licensee from all requirements in 10 CFR part 71, except for §§ 71.5 and 71.88, when shipping a Type A quantity. Because the NRC is proposing to revise §§ 71.22 and 71.23 to authorize shipment of a Type B quantity of radioactive material, an NRC package approval would be required for shipment of the Type B quantity of radioactive material. The NRC package approval for the Type B quantity of radioactive material would not include evaluation of criticality safety because the criticality safety is assured for shipment of fissile material authorized under one of these general licenses.

While NRC is not proposing to revise §§ 71.22(b) and 71.23(b), which require that the licensee have an NRC-approved QAP. Applications for QAP approvals use a graded approach, based on the planned activities and shipments that a licensee plans to make. For example, if a licensee has a QAP that was approved for making only Type A shipments under § 71.22 or § 71.23, then the licensee would need to obtain additional NRC approval for a QAP that includes QA items necessary for making Type B shipments.

In addition, because the NRC is proposing to authorize shipments of Type B packages in §§ 71.22 and 71.23, the NRC is proposing to include three new paragraphs in §§ 71.22 and 71.23 that are similar to the requirements in § 71.17(c), (d), and (e). The NRC is proposing to add a new requirement in §§ 71.22(f) and 71.23(f) to ensure that, for shipments made using the respective general license, each licensee must comply with § 71.17(c), i.e., the licensee must: (1) maintain a copy of the NRC approval, including all referenced documents; (2) comply with the terms and conditions of the NRC approval and the applicable requirements of subparts A, G, and H in 10 CFR part 71; and (3) prior to first use, register to use the package. A licensee is only required to register once to use a package, and therefore a licensee already registered to use the package via § 71.17 would not have to re-register to use the package under one of these two general licenses.

The NRC is proposing to add a new requirement in §§ 71.22(g) and 71.23(g) to state that, for a package to be used under the respective general license, the NRC package approval must state that the package can be used under the general license in either § 71.17 or the general license in § 71.22 or § 71.23. Authorizing use under the general license in § 71.17 would ensure that existing, approved Type B package designs could also be used to transport the material authorized by one of the two general licenses in § 71.22 or § 71.23.

Finally, the NRC is proposing to add a new requirement in §§ 71.22(h) and 71.23(h) to ensure that any Type B package used under the respective general license approved by the NRC before the effective date of the final rule is subject to the transitional arrangements in § 71.19. Issue 10 in Section III of this document describes the NRC's proposed changes to its transitional arrangements.

In summary, the NRC is proposing to remove the restriction in §§ 71.22 and 71.23 to ship Type A material in only a Type A package ( i.e., allowing shipment of material up to the mass limits in a Type B package); to add three new paragraphs in §§ 71.22 and 71.23; and to make conforming changes to § 71.0(d)(1). Additionally, the NRC is proposing to clarify that only special form sealed sources, not just sealed sources may be delivered to a carrier for transport using the general license in § 71.23.

The general license criteria in § 71.22 allow NRC licensees to ship small quantities of fissile material in packages that have been assigned a CSI to ensure accumulation control for packages on a conveyance. General license users assign a CSI based on the equation in § 71.22(e)(1), and the fissile mass limits in either Table 71-1 or 71-2 to 10 CFR part 71. Table 71-2 contains mass limits for shipping uranium enriched to various weight percent levels in 235 U. However, § 71.22(e)(5) states in part that the lower mass values of Table 71-1 must be used if the enrichment level of uranium is unknown, if the amount of plutonium exceeds one percent of the mass of 235  U, or if 233  U is present in the package.

While 233  U is not present in natural uranium, it may be present in very low concentrations in some facilities that may have handled 233  U in the past. These contamination-level concentrations, while detectable with modern isotopic assay methods and physically “present,” are not important for criticality safety of 235  U transportation. The calculations used to support the enrichment limit for § 71.15(d), for up to 1.0 weight percent enriched uranium, demonstrate that this limit is safe provided the plutonium and 233  U are limited to less than one percent of the mass of 235  U. The same limitation could be applied to the use of Table 71-2 limits for shipping enriched uranium under § 71.22, without affecting criticality safety.

The NRC is therefore proposing to revise § 71.22 to limit the 233  U to less than one percent of the mass of 235  U, similar to the provision limiting plutonium in § 71.22(e)(5)(ii).

As described in the draft regulatory basis, Issue 15 groups several topics identified by the NRC, some of which are not directly related to harmonizing NRC requirements with IAEA standards, and include clarifications to ensure compatibility with the DOT and clarifications to Agreement State regulations.

In the 2002 proposed rule (67 FR 21390, April 30, 2002), the NRC proposed changes to its reporting requirements in § 71.95, “Reports.” Those proposed changes would have: (1) required licensees to obtain certificate holder input before submitting an event report; (2) provided direction on the content of the written report; and (3) lengthened the reporting requirement date to 60 days, consistent with other reporting requirements in NRC regulations. The proposed rule recommended adding 71.95(a)(1) and (2) and 71.95(b), but not the current 71.95(a)(3).

In the final rule (69 FR 3697, January 26, 2004), the NRC stated that the proposed rule had inadvertently left out new paragraph (a)(3), mentioned in the proposed rule's regulatory analysis, that would retain the existing requirement for licensees to report instances of failure to follow the conditions of the CoC while a packaging was in use. Paragraph (a)(3) was thus added to the final rule. However, in adding that paragraph to the final rule, the NRC introduced duplicative language between it and paragraph (b).

The NRC is proposing to delete the duplicative text in paragraph (a)(3).

The NRC is proposing to modify the first sentence in the definition of “Low Specific Activity (LSA) material” in § 71.4 to change “excepted under § 71.15” to “exempted under § 71.15.” This change would make the definition of LSA in § 71.4 consistent with the title of § 71.15, “Exemption from classification as fissile material” and ensure that it is clear that LSA packages may contain fissile material up to the exemption limits in § 71.15.

The IAEA has made changes in SSR-6, 2018 Edition, related to the A 1 and A 2 activity values and the exempt material activity concentrations and exempt consignment activity limits. The DOT is the lead agency for information related to the A 1 and A 2 values and for the exempt material activity concentrations and exempt consignment activity limits, as provided in 49 CFR 173.435 and 173.436, respectively. The NRC has corresponding information in 10 CFR part 71, Appendix A, Tables A-1 and A-2.

To be considered radioactive material under DOT's regulations ( i.e., Class 7 (radioactive) material as defined in 49 CFR 173.403), the material must exceed both the nuclide specific exemption concentration limit and the consignment exemption activity limit. The A 1 and A 2 values are quantities of radioactivity that are used in the transportation regulations to determine the type of packaging necessary for a particular radioactive material shipment. Each radionuclide is assigned an A 1 and an A 2 value, where A 1 is the maximum activity of special form material that is permitted in a Type A package, and A 2 is the maximum activity of normal form radioactive material that is permitted in a Type A package as prescribed in 10 CFR 71.4 and 49 CFR 173.403. The NRC's and the DOT's transportation regulations include package activity limits based on fractions or multiples of the A 1 and A 2 values ( e.g., 10 − 3 A 2 and 3,000A 2 , respectively).

In its concurrent harmonization rulemaking, the DOT is proposing to make changes to 49 CFR 173.435, “Table of A 1 and A 2 values for radionuclides,” and 173.436, “Exempt material activity concentrations and exempt consignment activity limits for radionuclides,” by adding seven radionuclides, including barium-135m, germanium-69, iridium-193m, nickel-57, strontium-83, terbium-149, and terbium-161. The NRC is proposing to make corresponding changes to Tables A-1 and A-2 to add these radionuclides. The NRC is proposing to revise the specific activity of natural rubidium (Rb(nat)) to correct an error that was introduced in the 1995 version of the rule. Table A-1 of Appendix A to 10 CFR part 71 gives the specific activity as 6.7 × 10 6 TBq/g, 1.8 × 10 8 Ci/g. However, the correct value for the specific activity of Rb(nat) is 670 Bq/g (6.7 × 10 − 10 TBq/g, 1.8 × 10 − 8 Ci/g). The A 1 and A 2 values were not impacted by this error and remain correct. The NRC is also proposing to revise footnote c at the end of Table A-2 to state that in the case of thorium-natural, the parent radionuclide is thorium-232, and in the case of uranium-natural, the parent radionuclide is uranium-238. Further, the NRC is proposing to editorially revise several other radionuclides to move the name of the element and its atomic number (shown in the second column of each table) to the first instance of that element alphabetically in the tables.

The NRC is proposing several changes to the compatibility category designations related to the QAP and reporting requirements. These changes would ensure that Agreement States have the appropriate authority to approve, inspect, and enforce QAPs for their licensees, as well as that the NRC and Agreement States receive important reports regarding issues with radioactive material shipments.

The NRC is proposing to revise the compatibility category designations for the regulations containing QAP requirements for those Agreement States that have licensees located within their States who use NRC-approved Type B packages, other than for industrial radiography, to ship Type B quantities of radioactive material; or have licensees that ship using the general license in § 71.21, “General license: Use of foreign approved package”; § 71.22, “General license: Fissile material”; or § 71.23, “General license: Plutonium-beryllium special form material.” The NRC is also proposing to revise the compatibility category designation for the reporting requirements in § 71.95.

In the 2004 final rule (69 FR 3697; January 26, 2004) that revised § 71.101, “Quality assurance requirements,” the NRC stated that § 71.101(b), and (c)(1) are designated as Compatibility Category C for those Agreement States that have licensees that use Type B packages, other than for industrial radiography. For Compatibility Category C, the essential objectives of the NRC program elements should be adopted by such Agreement States. The NRC is proposing to change the compatibility category designation for 71.101(b) and (c)(1) from C to B. This is consistent with Management Directive 5.9, “Adequacy and Compatibility of Program Elements for Agreement State Programs,” which states that program elements in Compatibility Category B are those that apply to activities that cross jurisdictional boundaries. Since the QAP activities in 71.101(b) and (c)(1) are used during domestic shipping of radioactive material and therefore cross jurisdictional boundaries, a B compatibility would align with Management Directive 5.9 criteria. Also, many of the regulations that contain QAP review criteria ( e.g., §§ 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125) were addressed in the 2004 rule, but were designated as Compatibility Category NRC, which relate to areas of regulation reserved to the NRC that cannot be adopted by the Agreement States. The NRC is proposing to address these compatibility issues in this proposed rule so that, consistent with the intent of the 2004 rulemaking, Agreement States can adopt compatible QAP regulations that would require their licensees to follow these QAP criteria and allow Agreement States to approve, inspect and enforce their licensees' QAPs. Specifically, this rule proposes to correct the compatibility category designation to B for many of these regulations that are currently Compatibility Category NRC, C, or D. This change would require Agreement States to have essentially identical regulations and would give the Agreement States the authority to approve, inspect and enforce their licensees' QAPs. Only Agreement States with licensees that use Type B packages, other than for industrial radiography, or with licensees that ship using the general license in § 71.21, § 71.22, or § 71.23, which also requires an approved QAP, would be impacted.

Additionally, the regulations in § 71.95 require NRC licensees to submit a written report to the NRC of instances in which there is a significant reduction in the effectiveness of any NRC-approved package; details of defects with safety significance in any NRC-approved package, after first use; and instances in which the conditions of a CoC were not followed during shipment. In the 2004 final rule (69 FR 3697; January 26, 2004) that revised § 71.95, the NRC stated that the compatibility category for § 71.95 is Category D; therefore, it does not need to be adopted by the Agreement States to be compatible with the NRC's regulatory program. The reporting requirements in § 71.95(a) are to ensure that the NRC is alerted to instances in which a package may have a defect or has a significant reduction in effectiveness such that, as needed, other licensees authorized to use the package are made aware of the possible issues. Agreement State licensees also use NRC-approved packages, including industrial radiography devices, but are not subject to any of the requirements in § 71.95 and, therefore, are not required to submit a report to the NRC pursuant to § 71.95. The NRC is proposing to change the compatibility category for § 71.95(a) to Compatibility Category C in order to have Agreement State regulations require notification to the NRC of these instances. This will clarify that if a State licensee uses an NRC-approved package that has a defect or has a significant reduction in effectiveness the NRC is aware such that others using the package can be made aware of the situation. The NRC also is proposing to update the compatibility category for § 71.95(b) to Compatibility Category C to ensure that the Agreement State agency receives these reports from its licensees indicating instances when the CoC was not followed. As noted in the 1995 final rule (60 FR 50248, 50259), the purpose of this requirement is to provide feedback on QAP effectiveness. Consistent with the compatibility category corrections for other QAP related regulations, this proposed rule would also correct the compatibility category for § 71.95(b) so that Agreement States receive these QAP-related reports. The compatibility categories for § 71.95(c) and (d) would also be revised to Compatibility Category C so that these reports contain the required information.

In summary, the NRC is proposing to revise the compatibility category for (1) § 71.101(b) and (c)(1) from a Compatibility Category C to B to be in alignment with the criteria in Management Directive 5.9; (2) many of the QAP-related regulations ( e.g., §§ 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125) from a Compatibility Category NRC, C, or D to a B to allow the Agreement States the authority to approve, inspect and enforce these regulations; and (3) the reporting requirements in § 71.95(a) and (b) from a Compatibility Category D to C so that the NRC receives reports from Agreement State licensees on package defects pursuant to § 71.95(a), and that Agreement State regulators receive reports when their licensees do not use an NRC-approved package in accordance with the CoC pursuant to § 71.95(b), and to § 71.95(c) and (d) so that these reports contain the required information.

Section 71.97 is titled “Advance notification of shipment of irradiated reactor fuel and nuclear waste.” However, advance notification requirements for irradiated reactor fuel (and, equivalently, spent nuclear fuel) are separately included in the more general requirements of 10 CFR part 73, “Physical protection of plants and materials.” Specifically, as required in § 73.37(b)(2), licensees are required to provide advance notification of shipment to the Governor of a State and/or Tribal official for any shipment crossing the State or Tribal boundary when the shipment contains greater than 100 grams irradiated reactor fuel and the external radiation dose rate is greater than 1 Gy (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding. Licensees are also required to provide notification of such shipments to the NRC in accordance with § 73.72. Additionally, as required in § 73.35, “Requirements for physical protection of irradiated reactor fuel (100 grams or less) in transit,” licensees who transport 100 grams or less of irradiated reactor fuel, when the external radiation dose rate is greater than 1 Gy (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding, are required to provide advance notification of shipment in accordance with § 37.77. When 10 CFR part 37 was established in 2013, this requirement was introduced, but the “irradiated reactor fuel” aspect was not removed from § 71.97. Therefore, licensees may need to produce two reports for a single shipment to meet the advance notification requirements of §§ 71.97 and 73.37 or § 73.35. To address this potential inefficiency the NRC is proposing to modify § 71.97 to remove references to irradiated reactor fuel.

The NRC is seeking comment and feedback from the public on this proposed rule. The NRC is particularly interested in comment and supporting rationale from the public on the following:

Starting in 2016, while developing the regulatory basis for this proposed rule, the NRC considered the changes in SSR-6, 2012 Edition, and the proposed changes that were being considered for SSR-6, 2018 Edition, which were eventually issued in June 2018. The NRC contracted with Oak Ridge National Laboratory (ORNL) to develop ORNL/TM-2014/658, “Comparison of the International and United States Domestic Radioactive Material Transport Regulations.” In this document, ORNL compared both NRC and DOT regulations to SSR-6, 2012 Edition, and noted the differences. The NRC then compared the changes between SSR-6, 2018 Edition, and the 2012 Edition to determine which changes affect NRC regulations and whether those changes should be included in this proposed rule. Based on this review, the NRC did not include the following IAEA changes in the scope of this proposed rule:

1. Issue 1 consisted of four different sub-issues: Issue No. 1a: New Fissile Exceptions in IAEA SSR-6, paragraph 417; Issue No. 1b: Competent Authority-Approved Fissile Exception, SSR-6, paragraph 417(f); Issue No. 1c: CSI-Controlled Fissile Material Packages, SSR-6, paragraph 674; and Issue No. 1d: Plutonium Shipments in Type A Packages, SSR-6, paragraph 675.

For issue 1a, the NRC considered whether to adopt the fissile exceptions in paragraphs 417(c), without consignment limits in paragraph 570(c); the consignment limit in paragraph 570(d) associated with the package mass limit in paragraph 417(d); and the exception in paragraph 417(e) and its associated exclusive use restriction in paragraph 570(e), but with a mass limit of 140 g instead of the IAEA mass limit of 45 grams of fissile material from SSR-6, 2018 Edition, into the NRC regulations. The NRC chose not to adopt the consignment limits in 570(c) and (d) for the fissile exceptions in 417(c) and 417(d), respectively because consignment limits do not prevent the accumulation of packages on a transport conveyance, as there is no limit to the number of consignments that may be present on a single conveyance. Additionally, the accumulation on a single conveyance of the number of these packages required to approach criticality is not credible.

After evaluation of Issue 1b, the NRC is not proposing to add the new “competent authority-approved” fissile exception in paragraph 417(f) into the NRC regulations. If an NRC licensee wished to ship a material that did not meet the fissile material exemption or general license criteria in 10 CFR part 71, and for which demonstration of subcriticality in a package per the requirements of §§ 71.55 and 71.59 is deemed too burdensome, the licensee could request a specific exemption under § 71.12. The NRC notes that if an NRC licensee submitted a “competent authority-approved” exception, the approval would include both NRC and DOT reviews and issuance of the exception and the NRC review and findings would be similar to those of either an exemption or NRC-issued CoC.

After evaluation of Issue 1c, the NRC is not proposing to add CSI-controlled fissile material packages that the IAEA incorporated into SSR-6, paragraph 674. The IAEA SSR-6, paragraph 674(a), contains fissile material mass limits (per Table 13 in SSR-6, paragraph 674) and a CSI determination for packages with a minimum external dimension of 10 centimeters, which are not required to withstand normal conditions of transport in SSR-6, paragraphs 719-724. The IAEA SSR-6, paragraph 674(b), contains similar fissile material mass limits, and a formula for determination of a lower CSI, for packages which withstand normal conditions of transport while maintaining a larger minimum external dimension of 30 centimeters. The IAEA SSR-6, paragraph 674(c), contains the same CSI calculation as paragraph 674(b), for packages that withstand normal conditions of transport while maintaining a minimum external dimension of 10 centimeters, with a limit of 15 grams fissile material per package.

The NRC does not propose to adopt the changes in IAEA SSR-6, paragraph 674, because the NRC has determined that the mass limits and other requirements in §§ 71.22 and 71.23 are appropriate for providing criticality safety equivalent to packages approved under the criticality safety requirements of §§ 71.55 and 71.59. Adopting the provisions of IAEA SSR-6 would result in more restrictive mass limits for the fissile material general licenses authorized under 10 CFR part 71.

The NRC evaluated issue 1d, SSR-6, paragraph 675, to add NRC requirements for shipment of plutonium in a nonfissile package, with accumulation control provided by the calculation of a CSI. This provision was included in SSR-6, 2012 Edition but without accumulation control. The NRC's fissile exemption in § 71.15(f) is similar in that it limits the package to 1000 g of plutonium, of which not more than 20 percent by mass may be plutonium-239, plutonium-241, or any combination of the two; however, the NRC regulation does not include accumulation control via a CSI calculation. The NRC has determined that the fissile exemption in § 71.15(f) is safe without accumulation control, and that there is no safety benefit to limiting accumulation through the use of a CSI, in order to be consistent with the IAEA standards. Therefore, the NRC is not proposing to harmonize with paragraph 675, SSR-6, 2018 Edition.

2. The NRC considered adopting the reduced external pressure value of 60 kPa from paragraph 645 and the air transport package requirements from paragraph 621. The NRC is not proposing to harmonize with paragraphs 621 and 645, SSR-6, 2018 Edition, as discussed for Issue 2 in Section III of this proposed rule, to avoid creating unnecessary mode-specific restrictions within 10 CFR part 71.

3. Inclusion of Type C Package Standards (paragraphs 669-672)—The NRC considered adding Type C package standards for domestic transport, but there was not an expressed need for domestic transport of packages approved to Type C standards. Therefore, the NRC is not proposing to add Type C package standards in this proposed rule.

4. Testing and reporting the integrity of the containment system and shielding, and assessing criticality safety (paragraph 716), and additional description of the impact of the tests on packages (paragraphs 718-737)—The NRC reviewed its regulations for an application for approval of a package design and considered its regulations sufficient to obtain the information needed to determine whether a package design meets the requirements in 10 CFR part 71.

5. Addition of LSA Fissile Shipments (paragraphs 518, 519, 520)—Since LSA packages are self-certified under DOT regulations, other than the fissile material exemptions (§ 71.15) and fissile material general licenses (§§ 71.22 and 71.23), there is no mechanism for adding fissile material to an LSA package without NRC approval. Under current NRC regulations, the package could be certified but would become a Type BF or Type AF package, depending on the quantity of radioactive material in the package, and therefore the NRC did not consider any revision necessary.

6. Safety Factors for Lifting Attachments (paragraph 608)—The NRC regulations in § 71.45 contain quantitative criteria for evaluating lifting attachments that are considered a structural part of the package. The IAEA standards state an “appropriate” safety factor must be used. In its review, the NRC determined that adopting the IAEA changes would not result in safety benefits beyond those in § 71.45.

7. Shipment after Storage and Gap Analysis (paragraphs 503(e) and 809(k))—The IAEA added regulations both for shipment after storage and a gap analysis for packages in storage prior to shipment. The regulations in SSR-6, paragraph 503(e), require that during storage, packages are maintained to ensure that all relevant transportation standards in SSR-6 and certificates of approval for those packages will be fulfilled. The NRC is not proposing to adopt paragraph 503(e) because, during its review of packages for which storage is expected prior to transport ( i.e., dual purpose casks or canisters), the NRC ensures that the evaluations, operating procedures, maintenance program and acceptance tests for transport take storage into consideration. In addition, for any package that is stored prior to transport, existing NRC requirements (§§ 71.17(c) and 71.87(b)) ensure that, prior to transport, the licensee must comply with the terms and conditions of the NRC approval for the package design and ensure the package is in unimpaired physical condition. Following the operating procedure, maintenance program, and acceptance tests in the application is a condition of approval in all NRC-approved CoCs.

The NRC is not proposing to adopt paragraph 809(k), which requires “periodic evaluation of changes of regulations, changes in technical knowledge and changes of the state of the package design during storage.” The NRC's transitional arrangements authorize continued use of package designs approved to prior versions of the NRC regulations, with limitations on fabrication and restrictions on modifications to package designs without the need to demonstrate full compliance with the revised regulations. Package designs compliant with the existing regulations do not become “unsafe” when the regulations are revised (unless a significant safety issue is corrected in the revision). If a significant safety issue is corrected in a rulemaking, NRC certificate holders for that package design or type of package would be informed via generic communication ( e.g., regulatory information summary, bulletin, or generic letter), and as appropriate, required to take action, prior to a potential rule change. In addition, as stated previously, prior to transport the licensee must comply with the terms and conditions in the NRC approval and ensure the package is in unimpaired physical condition.

• Is there anything in SSR-6, 2018 Edition, that the NRC did not include in the scope of this proposed rule, but should have? In your comment, please explain why the NRC should consider adding the change to the final rule and the associated benefits.

The NRC transportation regulations in 10 CFR part 71 include appendix A to 10 CFR part 71, “Determination of A 1 and A 2 .” The introductory material in paragraphs I-V to appendix A includes information related to determining A 1 and A 2 values. Appendix A includes four tables:

The Secretary of Transportation has the authority to regulate the transportation of hazardous materials per the Hazardous Materials Transportation Act, as amended and codified in 49 U.S.C. 5101, et seq. The Secretary is authorized to issue regulations to implement the requirements of the statute. The DOT's Pipeline and Hazardous Materials Safety Administration has been delegated the responsibility for the hazardous materials regulations, which are contained in 49 CFR parts 100-185. These regulations include the requirements for Class 7 (radioactive) material.

The DOT maintains the same information in 49 CFR 173.433 through 49 CFR 173.436 as found in the NRC's appendix A to 10 CFR part 71. With the authority to regulate the transportation of hazardous materials, including Class 7 (radioactive) material, DOT is the lead agency for determining the basic radionuclide values (A 1 and A 2 values) and the exempt material activity concentrations and exempt consignment activity limits for radionuclides that are used in radioactive material transportation activities. The DOT regulations include:

The NRC recognizes challenges associated with maintaining the accuracy and consistency of all the information in appendix A to 10 CFR part 71 with the parallel information in 49 CFR chapter I, considering, in part, the periodic updates the DOT makes to these regulations to harmonize with IAEA standards. Therefore, to minimize duplicative information within the domestic transportation regulations, and to recognize the DOT's authority to regulate Class 7 (radioactive) material, the NRC is considering removing the content of appendix A to 10 CFR part 71. Where it is necessary within the subparts of 10 CFR part 71, the NRC would remove all references in 10 CFR chapter I to information in appendix A to 10 CFR part 71 and replace those with references to the appropriate regulation in 49 CFR chapter I.

• Please comment on whether the NRC should consider removing Tables A-1 through A-4 in appendix A to 10 CFR part 71 and instead refer to the appropriate DOT tables in 49 CFR chapter I, rather than updating Tables A-1 through A-4 in appendix A to 10 CFR part 71 as currently shown in this proposed rule. If so, would there be a benefit to members of the public, including applicants and licensees? Please explain your rationale.

As described in Section III of this document, in Issue 12, the NRC is proposing to revise § 71.106 to achieve NRC's stated intent in the 2015 final rule. Specifically, the NRC is proposing to revise § 71.106(b) to clarify that a biennial report must be submitted to the NRC even if no changes are made to the QAP during the reporting period. This proposed requirement would benefit the NRC's regulatory oversight of QAP approval holders. The NRC inspection program for 10 CFR part 71 QAP approval holders relies on having current information about the QAP available to the NRC, including the reporting of no changes. The 24-month reporting period aims to provide an appropriate balance between the burden placed on the QAP approval holders and the need to ensure that the NRC has current information, especially when considering most QAP approval holders subject to periodic inspection are inspected every 5 years or on an as-needed basis. Another benefit is that the revised QAP reporting requirements in 10 CFR part 71 would be consistent with those in 10 CFR 50.54(a)(3) and 50.71(e)(2) for 10 CFR part 50 QAPs. The benefits and costs of the proposed requirement are described in the regulatory analysis and the NRC estimates that the cost of compliance is very small. The NRC is interested in the public's feedback as to the benefits and costs of requiring a no-change biennial report.

• Please comment on the benefits and costs of requiring a 10 CFR part 71 QAP approval holder to submit a biennial report to the NRC even if no changes are made to the QAP during the reporting period.

The following paragraphs describe the specific changes in this proposed rule.

This proposed rule would revise paragraph (d)(1) to clarify general license package approval requirements.

This proposed rule would revise the definitions for Low Specific Activity material, Special form radioactive material, and Surface Contaminated Object, delete the definition for Low Specific Activity—III Leaching Test, and add a new definition for Radiation level.

This proposed rule would revise the introductory paragraph by replacing (f) with (g), paragraph (a) by adding new subparagraphs (1) and (2), paragraph (d) by replacing “of up to” with “not exceeding, and add paragraph (g), which is a new provision for exclusive use of transportation packages.

This proposed rule would revise paragraph (e) to change the design approval date for Type B or fissile material packages from April 1, 1996, to the effective date of the final rule.

This proposed rule would revise paragraph (a) to include existing CoCs that have a “-96” in their package identification number, redesignate paragraphs (c) and (d) as paragraphs (d) and (e), revise newly redesignated paragraph (e) to include those CoCs that have a suffix “-96” in their identification numbers, and add new paragraph (c), to add transitional arrangements on existing CoCs that have a “-96” in their package identification number.

This proposed rule would revise paragraph (a) to replace “subparts E and F of this part” with “§§ 71.55 and 71.59” and to remove the limitation to a Type A quantity of radioactive material in a Type A package to allow shipment of material under the general licenses in §§ 71.22 and 71.23 in a Type B package, paragraph (c) to remove (c)(1) and redesignate paragraph (c)(2) as new paragraph (c), paragraphs (e)(3) through (5) to limit the 233 U to less than one percent of the mass of 235 U, similar to the provision limiting plutonium in § 71.22(e)(5)(ii), and add new paragraphs (f) through (h) to ensure that each licensee will comply with § 71.17(c) for shipments made using the respective general license and that any Type B package used under the respective general license approved by the NRC before the effective date of the final rule is subject to the transitional arrangements in § 71.19.

This proposed rule would revise paragraphs (a) and (c), and add paragraphs (f) through (h) to clarify that only special form sealed sources, not just sealed sources may be delivered to a carrier for transport using the general license in § 71.23.

This proposed rule would revise paragraph (a) to add a maintenance program description, as required by § 71.35 among the contents of application.

This proposed rule would revise paragraph (b) to delete “and” paragraph (c) to add “; and” and add new paragraph (d) to specify maintenance program requirements.

This proposed rule would revise paragraph (d) to specifically include the evaluation of the effects of aging, and to specify that degradation evaluations will be managed by the maintenance program in accordance with § 71.35(d), and add new paragraph (i) to specify that each system designed to contain liquids has adequate ullage during evaluation of the tests and conditions for normal conditions of transport and hypothetical accident conditions specified in §§ 71.71 and 71.73.

This proposed rule would revise paragraph (g)(1) to require that there is no contact between the cylinder plug and any other part of the packaging, other than at its original attachment point and that the cylinder plug remains leak tight, as NRC requires for the cylinder valve.

This proposed rule would change the unit of measure in the table in paragraph (c)(1) to change the unit of measure for the values of insolation used for the heat test for normal conditions of transport from “(g cal/cm 2 )” to “(W/m 2 )”.

This proposed rule would revise paragraph (b) to add insolation to the initial conditions for the tests for hypothetical accident conditions.

This proposed rule would remove and reserve § 71.77 and make conforming changes to §§ 71.4 and 71.100.

This proposed rule would remove paragraph (a)(3) as it is duplicative to text in paragraph (b).

This proposed rule would revise the section title, the introductory text of paragraph (b), and paragraphs (d) and (f)(1) to remove references to irradiated reactor fuel to correct a duplicative advance notification reporting requirement in § 71.97 with those in §§ 73.35 and 73.37.

This proposed rule would revise paragraph (b) to remove the leaching test requirement as a conforming change to § 71.77.

This proposed rule would revise the introductory text of paragraph (b) to clarify that a biennial report must be submitted to the NRC even if no changes are made to the QAP during the reporting period.

This proposed rule would revise Tables A-1 and A-2 in paragraph V.b. to add seven radionuclides and correct the specific activity of natural rubidium.

Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this proposed rule will not, if issued, have a significant economic impact on a substantial number of small entities. This proposed rule affects a number of “small entities” as defined by the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). However, as indicated in the regulatory analysis, these amendments do not have a significant economic impact on the affected small entities.

The NRC has prepared a regulatory analysis on this proposed rule. The analysis examines the costs and benefits of the alternatives considered by the NRC and includes consideration of the costs and benefits of updating guidance. The NRC requests public comment on the regulatory analysis. The regulatory analysis is available as indicated in the “Availability of Documents” section of this document. Comments on the regulatory analysis may be submitted to the NRC as indicated under the ADDRESSES section of this document.

The NRC has determined that backfitting (§ 50.109, § 70.76, § 72.62, or § 76.76) and the issue finality provisions in 10 CFR part 52 do not apply to this proposed rule because it would not involve any provisions that would impose backfits as defined in 10 CFR chapter I or affect the issue finality of any approval issued under 10 CFR part 52. Some licensees that are within the scope of the backfit rule ( e.g., a power reactor or a fuel fabrication facility) transport radioactive material from their own facilities. Those backfitting and issue finality provisions apply to activities directly regulated under those parts, and do not apply to activities regulated under other parts that do not include backfitting or issue finality provisions. The exception to this general principle is where the activity regulated under other parts that do not include backfitting or issue finality provisions is an inextricable part of the regulated activity within the scope of backfitting or issue finality. Preparing packages for transport is not an inextricable part of the procedures or organization required to design, construct or operate a facility as licensed under 10 CFR part 50, 52, 70, 72, or 76; rather, it is a separate activity that these licensees may choose to undertake. The scope of this proposed rule does not include any changes to any of those facilities or plants' activities for which the backfit rule applies.

The NRC's determination on this matter is in accordance with Management Directive 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests,” and its associated guidance in NUREG-1409, “Backfitting Guidelines.”

The NRC seeks to minimize any potential negative consequences resulting from the cumulative effects of regulation (CER). The CER describes the challenges that licensees, or other impacted entities such as State partners, may face while implementing new regulatory positions, programs, or requirements ( e.g., rules, generic letters, backfits, inspections). The CER is an organizational effectiveness challenge that may result from a licensee or impacted entity implementing a number of complex regulatory actions, programs, or requirements within limited available resources.

To better understand the potential CER implications incurred due to this proposed rule, the NRC is requesting comment on the following questions. Responding to these questions is voluntary, and the NRC will respond to any comments received in the final rule.

1. In light of any current or projected CER challenges, does the proposed rule's effective date provide sufficient time to implement the new proposed requirements, including changes to programs and procedures?

2. If current or projected CER challenges exist, what should be done to address this situation? For example, if more time is required for implementation of the new requirements, what period of time is sufficient?

3. Do other regulatory actions (from the NRC or other agency) influence the implementation of the proposed rule's requirements?

4. Are there unintended consequences? Does the proposed rule create conditions that would be contrary to the proposed rule's purpose and objectives? If so, what are the unintended consequences, and how should they be addressed?

5. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports this proposed rule.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.

The Commission has preliminarily determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in subpart A of 10 CFR part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and an environmental impact statement is not required. The basis of this determination is as follows: The amendments would change the requirements for packaging and transportation of radioactive material. The amendments would make changes to harmonize the NRC's regulations with the 2018 Edition of the IAEA's transport standards (SSR-6) and with that of the DOT's regulations under 49 CFR and include NRC-initiated changes. The environmental impacts arising from the changes have been evaluated and would not involve any significant environmental impact. This includes consideration of direct, indirect, and cumulative impacts. Other amendments are procedural in nature and would have no significant impact on the environment.

The preliminary determination of this environmental assessment is that there will be no significant effect on the quality of the human environment from this action. Public stakeholders should note, however, that comments on any aspect of this environmental assessment may be submitted to the NRC as indicated under the ADDRESSES caption. The environmental assessment is available as indicated under the “Availability of Documents” section of this document.

The NRC has sent a copy of the environmental assessment and this proposed rule to every State Liaison Officer and has requested comments.

This proposed rule contains new or amended information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This proposed rule has been submitted to the Office of Management and Budget (OMB) for review and approval of the information collection requirements.

Type of submission, new or revision: Revision.

The title of the information collection: Harmonization of Transportation Safety Requirements with IAEA Standards.

The form number if applicable: Not applicable.

How often the collection is required: Applications for changes reducing commitments to the NRC on quality assurance programs and for package approval are submitted on occasion. Quality assurance program reporting on changes determined not to reduce commitments, or reporting of no changes made, is done every 24 months. Reporting packaging issues or instances in which the conditions in a CoC are not followed occur infrequently.

Who will be required or asked to report: General or specific licensees who use a package, certificate holders and applicants for a new or amended CoC.

An estimate of the number of annual responses: 7.5.

The estimated number of annual respondents: 6.5.

An estimate of the total number of hours needed annually to complete the requirement or request: 1,376.7 hours (an increase of 1,052.5 hours reporting + an increase of 322.7 third party disclosure hours and 1.5 hours recordkeeping).

Abstract: The NRC, in consultation with the DOT, is proposing to amend its regulations for the packaging and transportation of radioactive material. The Commission has historically been consistent in its support of harmonizing the NRC transportation regulations with the IAEA's standards. These amendments would make the NRC regulations conform to the recent revisions to the IAEA standards for the international transportation of radioactive material and maintain consistency with the DOT regulations. These changes are necessary to maintain a consistent regulatory framework for the packaging and transportation of radioactive material. The NRC is also proposing to amend these regulations to include administrative, editorial, or clarifying changes, including changes to certain Agreement State compatibility category designations.

The NRC is seeking public comment on the potential impact of the information collections contained in this proposed rule and on the following issues:

1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

2. Is the estimate of burden of the proposed information collection accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

A copy of the OMB clearance package is available in ADAMS under Accession No. ML20101F920. You may obtain information and comment submissions related to the OMB clearance package by searching on https://www.regulations.gov under Docket ID NRC-2016-0179.

You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues, by the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2016-0179.

• Mail comments to: FOIA, Library, and Information Collections Branch T6-A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to Infocollects.Resource@nrc.gov.

• Submit to OMB Directly: Written comments and recommendations for the proposed information collection should be sent within 60 days of publication of this document to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently Under Review—Open for Public Comments” or by using the search function.

Comments on the information collections will be publicly available in ADAMS and on Reginfo.gov. Submit comments by November 14, 2022. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

For the purposes of Section 223 of the Atomic Energy Act of 1954, as amended (AEA), the NRC is issuing this proposed rule that would amend 10 CFR part 71 under one or more of Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule would be subject to criminal enforcement. With the following exception, none of the proposed amendments would change the manner in which criminal penalties would be assessed or enforced.

Criminal penalties as they apply to regulations in 10 CFR part 71 are discussed in § 71.100. One of the actions within the scope of this rulemaking, Issue 6, Deletion of the Low Specific Activity—III Leaching Test, proposes to remove the content of § 71.77 and replace the section heading with “RESERVED.” This change would impact § 71.100(b), because § 71.77 would be removed from that paragraph as the leaching test would no longer be required.

The NRC has coordinated with the Agreement States throughout the development of this proposed rule. Agreement State representatives have served on the rulemaking working group that developed this proposed rule and on the Standing Committee on Compatibility for the rulemaking. The NRC also provided a preliminary draft of the proposed rule to the Agreement States for review.

Under the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017 and published in the Federal Register on October 18, 2017 (82 FR 48535), NRC program elements (including regulations) are placed into compatibility categories A, B, C, D, NRC, or adequacy category Health and Safety (H&S). Compatibility Category A program elements are those program elements that are basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts. An Agreement State should adopt Category A program elements in an essentially identical manner in order to provide uniformity in the regulation of agreement material on a nationwide basis. Compatibility Category B program elements are those program elements that apply to activities that have direct and significant effects in multiple jurisdictions. An Agreement State should adopt Category B program elements in an essentially identical manner. Compatibility Category C program elements are those program elements that do not meet the criteria of Category A or B but do contain the essential objectives that an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a national basis. An Agreement State should adopt the essential objectives of the Category C program elements. Compatibility Category D program elements are those program elements that do not meet any of the criteria of Category A, B, or C and, therefore, do not need to be adopted by Agreement States for purposes of compatibility. Compatibility Category NRC program elements are those program elements that address areas of regulation that cannot be relinquished to the Agreement States under the Atomic Energy Act of 1954, as amended, or provisions of title 10 of the Code of Federal Regulations. These program elements should not be adopted by the Agreement States. Adequacy category H&S program elements are program elements that are required because of a particular health and safety role in the regulation of agreement material within the State and should be adopted in a manner that embodies the essential objectives of the NRC program. A bracketed compatibility category ( e.g., [B]) means that the provision may have been adopted elsewhere in the Agreement State's regulations and does not need to be adopted again.

As discussed in Section III of this document, Issue 15.4, the regulations that contain QAP requirements ( e.g., §§ 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125) are currently designated as Compatibility Category NRC and cannot be adopted by the Agreement States. Since a proper QAP review cannot be completed without addressing many of these criteria, Agreement States would need to adopt compatible regulations to require licensees that use NRC-approved Type B packages for shipping, other than for industrial radiography, or that ship using the general license in § 71.21, § 71.22 or § 71.23, to follow these QAP criteria. Additionally, since only a few Agreement States have applicable licensees that perform shipments of Type B quantities of radioactive materials, other than for industrial radiography operations (which are covered under § 34.31), or that ship using the general license in § 71.21, § 71.22, or § 71.23, all QAP-related requirements, including those mentioned previously and others referenced below in the table, would be re-designated as a Compatibility Category B. This re-designation would require those Agreement States with applicable licensees to have essentially identical regulations. For those Agreement States that do not have applicable licensees, these regulations will remain designated as Compatibility Category D and, hence, do not have to be adopted for purposes of compatibility.

The changes in this proposed rule, discussed in Section III of this document, would be a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. Regulations that are a part of this rulemaking but remain the same compatibility category designation are included in the table for completeness. The compatibility categories are designated in the following table.

The NRC invites comment on the compatibility category designations in the proposed rule and suggests that commenters refer to Handbook 5.9 of Management Directive 5.9, “Adequacy and Compatibility of Program Elements for Agreement State Programs,” for more information. The NRC notes that, like the rule text, the compatibility category designations can change between the proposed rule and final rule on the basis of comments received and Commission decisions regarding the final rule. The NRC encourages anyone interested in commenting on the compatibility category designations to do so during the comment period.

The National Technology Transfer and Advancement Act (NTTAA) of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies, unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this proposed rule, the NRC would revise regulations associated with packaging and transportation of radioactive material in 10 CFR part 71 to conform NRC regulations to the recent revisions to the IAEA standards for the international transportation of radioactive material. While the rule harmonizes NRC requirements with IAEA Standard SSR-6, it does not endorse SSR-6, and SSR-6 does not meet the criteria for being a voluntary consensus standard under the NTTAA. The NRC is not aware of any voluntary consensus standard that could be used. The NRC will consider using a voluntary consensus standard if an appropriate standard is identified. If a voluntary consensus standard is identified for consideration, the submittal should explain how the voluntary consensus standard is comparable and why it should be used. This action does not constitute the establishment of a standard that contains generally applicable requirements.

The NRC is issuing for comment draft guidance, DG-7011, “Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material,” Revision 3 to Regulatory Guide 7.9, for the implementation of the requirements in this proposed rule. The draft guidance identifies the information to be provided in an application for package approval and establishes a uniform format for presenting that information. The draft guidance is available in ADAMS under Accession No. ML22223A085. You may obtain information and comment submissions related to the draft guidance by searching on https://www.regulations.gov under Docket ID NRC-2016-0179. You may submit comments on the draft regulatory guidance by the methods outlined in the ADDRESSES section of this document.

The NRC considered whether a revision of NUREG-1608, “Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects,” was warranted in association with this proposed rule. NUREG-1608, published jointly by the NRC and the DOT in 1998, provides guidance to shippers of LSA material and SCO regarding significant changes to both 10 CFR part 71 and 49 CFR that became effective April 1, 1996. The NRC's judgement is that NUREG-1608 serves the purpose for which it was intended, which was to educate shippers about major changes to the regulations in 1996, and that the minor changes to the LSA and SCO requirements in this proposed rule do not warrant a revision to NUREG-1608.

The NRC also considered whether a revision of NUREG-1660, “U.S.-Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments,” was warranted in association with this proposed rule. NUREG-1660, published jointly by the NRC and the DOT in 1999, provides summaries of NRC, DOT, and other regulations that shippers must meet, depending on the type of material being shipped. NUREG-1660 is currently under revision to incorporate requirements issued in both 10 CFR chapter I and 49 CFR chapter I since 1999. The NRC's judgement is that there are no changes being considered in this proposed rule that will affect the content of the revised NUREG-1660.

The NRC considered whether a revision to NUREG-1886, “Joint Canada—United States Guide for Approval of Type B(U) and Fissile Material Transportation Packages,” is warranted in association with this rulemaking. NUREG-1886, published jointly with the DOT and the Canadian Nuclear Safety Commission (CNSC) in 2009, provides a standard format and content of an application for approval of Type B(U) and fissile material packages to demonstrate the ability of the given package to meet both United States (NRC and DOT regulations) and Canadian regulations. The NRC, the DOT, and the CNSC recently started discussions to update NUREG-1886, which will be a multiyear effort. When NUREG-1886 is updated, the NRC will ensure that it is consistent with the final version of DG-7011 and its associated Regulatory Guide 7.9.

The NRC considered whether a revision to NUREG-2216, “Standard Review Plan for Transportation Packages for Spent Fuel and Radioactive Material,” is warranted in association with this proposed rule. NUREG-2216, which was recently issued, provides guidance to the NRC staff for reviewing an application for package approval issued under 10 CFR part 71. There are no changes being considered in this proposed rule that would significantly affect the content of NUREG-2216. The NRC will first obtain experience using NUREG-2216 to evaluate whether there are more significant changes needed before making the relatively minor changes associated with this proposed rule.

The NRC will conduct a public meeting on this proposed rule to describe it to the public and to facilitate the development of public comments. The NRC will publish a notice of the location, time, and agenda of the meeting on Regulations.gov and on the NRC's public meeting website at least 10 calendar days before the meeting. Stakeholders should monitor the NRC's public meeting website for information about the public meeting at: https://www.nrc.gov/public-involve/public-meetings/index.cfm.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

Throughout the development of this proposed rule, the NRC may post documents related to it, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2016-0179. In addition, the Federal rulemaking website allows members of the public to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2016-0179); (2) click the “Subscribe” link; and 3) enter an email address and click on the “Subscribe” link.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing to adopt the following amendments to 10 CFR part 71:

The revisions and addition read as follows:

The revisions and addition read as follows:

The additions and revisions read as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1154; Project Identifier MCAI-2022-00550-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Gabriel Kim, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email 9-avs-nyaco-cos@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued TCCA AD CF-2022-20, dated April 19, 2022 (TCCA AD CF-2022-20) (also referred to after this as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. You may examine the MCAI in the AD docket at regulations.gov by searching for and locating Docket No. FAA-2022-1154.

This proposed AD was prompted by a report that the pressure switch gauge assembly for the cargo bay fire extinguisher container has the potential to display an incorrect pressure under certain environmental conditions. The supplier attributed the root cause of the container pressure display error to the use of a room temperature vulcanizing (RTV) silicone. Both the HRD and LRD cargo bay fire extinguisher containers are affected. The airplane is intended to be operated at temperatures as low as −53.8 °C (−65 °F). However, testing has shown that at temperatures below −49.4 °C (−57 °F), the RTV silicone goes through a glass transition that causes locking of the discharge indication microswitch in a closed state (showing normal pressure) on 50% of the assemblies tested. After returning to above −35.0 °C (−31.5 °F) for more than 6 minutes, the pressure switch gauge assembly returns to normal operation. The FAA is proposing this AD to address instances where the fire extinguisher container capacity is reduced below the level required to appropriately suppress a cargo fire and the flightcrew does not receive an indication of low pressure, which, in the event of a fire in the cargo bay, could lead to an uncontrollable fire and loss of the airplane. See the MCAI for additional background information.

MHI RJ Aviation ULC has issued Service Bulletin 670BA-26-013, dated October 8, 2021. This service information describes procedures for replacing the HRD and LRD pressure switch gauge assemblies for the cargo bay fire extinguisher containers having part number (P/N) 473919-1, P/N 473920-1 and P/N 474901-1, manufactured prior to March 2020 as indicated on the identification plate, with a serviceable part number.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in the service information already described.

The FAA estimates that this AD, if adopted as proposed, would affect 564 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1155; Project Identifier MCAI-2022-00655-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Dan Rodina, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198; telephone and fax 206-231-3225; email dan.rodina@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0089, dated May 17, 2022 (EASA AD 2022-0089) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A321-251N, A321-251NX, A321-252N, A321-252NX, A321-253N, and A321-253NX airplanes.

This proposed AD was prompted by a weakness identified by the manufacturer in the design of the CFM LEAP-1A aft engine mount waiting fail-safe male lug on the engine side. During a stress analysis on the engine structure, CFM discovered that the fail-safe lug may not be able to sustain, during one inspection interval, as currently specified in airworthiness limitation item (ALI) task 712232-01-1, the loads deriving from the engagement of the secondary load path within that inspection interval for the aft engine mount system. Consequently, the inspection interval must be reduced accordingly in order to meet the predicted life of the fail-safe lug. The FAA is proposing this AD to address potential failure of the LEAP-1A aft engine mount waiting fail-safe male lug, which could lead to engine mount rupture, possibly resulting in engine loss during flight and loss of control of the airplane. See the MCAI for additional background information.

EASA AD 2022-0089 specifies procedures for repetitive detailed inspections (DET) for discrepancies of the aft engine mount and secondary load path clearance fail-safe pin for each engine, and replacement of any engine with discrepant findings on the secondary load path clearance check.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2022-0089 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2022-0089 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2022-0089 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2022-0089 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0089. Service information required by EASA AD 2022-0089 for compliance will be available at regulations.gov by searching for and locating Docket No. FAA-2022-1155 after the FAA final rule is published.

The FAA estimates that this proposed AD would affect 156 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

Throughout this document “we,” “us,” and “our” refer to the EPA.

Submit your comments, identified by Docket ID No. EPA-R07-OAR-2022-0746, at www.regulations.gov. Once submitted, comments cannot be edited or removed from Regulations.gov . The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit www.epa.gov/dockets/commenting-epa-dockets.

On February 22, 2013, the EPA issued a Federal Register notice of proposed rulemaking outlining EPA's policy at the time with respect to SIP provisions related to periods of startup, shutdown and malfunction (SSM). EPA analyzed specific SSM SIP provisions and explained how each one either did or did not comply with the Clean Air Act (CAA) with regard to excess emission events. 1 For each SIP provision that EPA determined to be inconsistent with the CAA, EPA proposed to find that the existing SIP provision was substantially inadequate to meet CAA requirements and thus proposed to issue a SIP call under CAA section 110(k)(5).

On June 12, 2015, pursuant to CAA section 110(k)(5), EPA finalized “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls To Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown and Malfunction,” (80 FR 33839, June 12, 2015), hereafter referred to as the “2015 SSM SIP Action.” The 2015 SSM SIP Action clarified, restated, and updated EPA's interpretation that SSM exemption and affirmative defense SIP provisions are inconsistent with CAA requirements. The 2015 SSM SIP Action found that certain SIP provisions in 36 states were substantially inadequate to meet CAA requirements and issued a SIP call to those states to submit SIP revisions to address the inadequacies. The 2015 SSM SIP Action identified specific provisions of this Missouri rule, 10 Code of State Regulation (CSR) 10-6.220, Restriction of Emissions of Visible Air Contaminants as being substantially inadequate to meet CAA requirements. EPA established an 18-month deadline by which the affected states had to submit such SIP revisions. States were required to submit corrective revisions to their SIPs in response to the SIP calls by November 22, 2016.

EPA issued a Memorandum in October 2020 (2020 Memorandum), which stated that certain provisions governing SSM periods in SIPs could be viewed as consistent with CAA requirements. 2 Importantly, the 2020 Memorandum stated that it “did not alter in any way the determinations made in the 2015 SSM SIP Action that identified specific state SIP provisions that were substantially inadequate to meet the requirements of the Act.” Accordingly, the 2020 Memorandum had no direct impact on the SIP call issued to Missouri in 2015. The 2020 Memorandum did, however, indicate EPA's intent at the time to review SIP calls that were issued in the 2015 SSM SIP Action to determine whether EPA should maintain, modify, or withdraw particular SIP calls through future agency actions.

On September 30, 2021, EPA's Deputy Administrator withdrew the 2020 Memorandum and announced EPA's return to the policy articulated in the 2015 SSM SIP Action (2021 Memorandum). 3 As articulated in the 2021 Memorandum, SIP provisions that contain exemptions or affirmative defense provisions are not consistent with CAA requirements and, therefore, generally are not approvable if contained in a SIP submission. This policy approach is intended to ensure that all communities and populations, including overburdened communities, receive the full health and environmental protections provided by the CAA. 4 The 2021 Memorandum also retracted the prior statement from the 2020 Memorandum of EPA's plans to review and potentially modify or withdraw particular SIP calls. That statement no longer reflects EPA's intent. EPA intends to implement the principles laid out in the 2015 SSM SIP Action as the agency takes action on SIP submissions, including this SIP submittal provided in response to the 2015 SIP call.

With regard to the Missouri SIP, in the 2015 SSM SIP Action, EPA determined that a provision of 10 Code of State Regulations (CSR) 10-6.220 Restriction of Emissions of Visible Air Contaminants was substantially inadequate to meet CAA requirements (80 FR 33840, 33969). Specifically, 10-6.220(3)(c) provided: “Visible emissions over the limitations shown in subsection (3)(B) of this rule are in violation of this rule unless the director determines that the excess emissions do not warrant enforcement action based on data submitted under 10 CSR 10-6.050 Start-Up, Shutdown and Malfunction Conditions.” The rationale underlying EPA's determination that the provision was substantially inadequate to meet CAA requirements, and therefore to issue a SIP call to Missouri to remedy the provision, is fully detailed in the 2015 SSM SIP Action and the accompanying proposals. Specifically, EPA agreed with petitioners on the basis that this provision could be read to allow for exemptions from the otherwise applicable SIP emission limitations through a state official's unilateral exercise of discretionary authority that is insufficiently bounded and includes no additional public process at the state or federal level. In summary, EPA agreed with petitioners that this provision would allow the state director to circumvent EPA authority and/or citizen suit authority to enforce the emissions limitations, which is inconsistent with the CAA and EPA's policy outlined in the 2015 SSM SIP Action.

Missouri submitted a SIP revision on November 29, 2016, in response to the SIP call issued in the 2015 SSM SIP Action. In its submission, Missouri requests that EPA revise the Missouri SIP by removing the provision 10-6.220(3)(c) from the SIP, thereby correcting the deficiency identified in the 2015 SSM SIP Action and addressing the SIP Call for Missouri.

The EPA is proposing to approve Missouri's revisions to 10 CSR 10-6.220, Restriction of Emissions of Visible Air Contaminants, in the Missouri SIP. The EPA received two SIP revision submissions related to this state rule from the Missouri Department of Natural Resources (MoDNR) on November 29, 2016, and March 7, 2019. The full text of these changes as well as EPA's analysis of the changes can be found in the technical support document (TSD), which is included in the docket for this action.

In its November 29, 2016, submission, MoDNR requested to remove the provision that was identified by EPA as being substantially inadequate to meet CAA requirements in EPA's 2015 SSM SIP Action. EPA is proposing to determine that removal of this provision is consistent with EPA's policy outlined in the 2015 SSM SIP Action and sufficiently addresses the deficiencies identified by the 2015 SSM SIP Call.

In addition to the removal of the identified SSM deficiency, MoDNR, in both the 2016 and 2019 submissions, also requested revisions related to opacity monitoring requirements and exemptions from the opacity limits and recordkeeping and reporting requirements of 10 CSR 10-6.220 for certain source types. Specifically, MoDNR exempted specific, limited, emission units regulated by stricter federal and state regulations. MoDNR also provided an exemption for certain emission units that do not have the capability of exceeding the emission limits of the rule. One example of an added exemption is for units regulated under 40 CFR 63 subpart UUUUU— Mercury and Air Toxics Standards, that demonstrate compliance with a particulate matter continuous emission monitoring system (CEMS) as the limits in this federal rule are more stringent than the opacity limits contained in the state rule. The newly added exemptions for sources that already comply with more stringent state or federal requirements will remove the duplicative monitoring and reporting requirements associated with the less stringent requirements of the state opacity rule.

Missouri provided a demonstration pursuant to CAA section 110(l) to ensure the rule revisions, including the added exemptions, do not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act. EPA reviewed MoDNR's section 110(l) demonstration which explains the sources that will be newly exempt from the opacity limits of this state rule remain subject to more stringent federal or state regulations that apply on a continuous basis. For this reason, the emissions change associated with the rule revisions is expected to be relatively small if any. Additionally, the opacity limits contained in this rule, and more specifically for the units being exempted from the limits of this state rule, are not relied upon for attainment or maintenance purposes.

Opacity is often used as an indicator of the degree of particulate matter emissions. All PM 2.5 monitors in the state are measuring compliance with the annual and 24-hour PM 2.5 standards and all counties in Missouri are designated as unclassifiable/attainment for both the 2012 annual and 2006 24-hour PM 2.5 NAAQS. Further, the sources are not exempt from all opacity requirements and, in fact, are subject to the more stringent requirements found in the applicable federal rules. The expected change in emissions associated with these rule revisions is relatively small if any and therefore would not interfere with attainment or maintenance of the NAAQS.

Further, EPA is proposing to approve removal of the prior deficient exemption for excess emissions during periods of SSM from this rule. EPA believes that any emission limit or requirement relied upon as being more stringent to exempt a source from this rule must apply continuously, that is without any exemptions for periods of SSM, to be more stringent than the limits contained in this rule.

MoDNR also provided information to support the exemption for emission units burning certain fuels that are not capable of exceeding the opacity limits contained in the rule by estimating maximum emissions based on EPA emissions factors for each fuel type. EPA reviewed MoDNR's demonstration and proposes to agree that this added exemption would result in a relatively small emissions change if any and therefore would not interfere with attainment or maintenance of the NAAQS.

Based on EPA's review of Missouri's section 110(l) demonstration and our analysis of these changes as fully described in the TSD in the docket for this proposed rule, the expected change in emissions associated with these rule revisions is relatively small if any and therefore EPA proposes to find the revisions will not interfere with attainment or maintenance of the NAAQS or other CAA requirements consistent with CAA Section 110(l).

MoDNR also added an alternative test method and made other administrative wording changes such as adding rule specific definitions. EPA proposes to find these edits do not adversely impact the stringency of the SIP and are consistent with CAA requirements. Therefore, EPA proposes to approve these revisions as further detailed in the TSD.

The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on the November 29, 2016, SIP revision from June 1, 2016, to August 4, 2016, and held a public hearing on July 28, 2016. During the public comment period, the State received seven comments from five sources, consisting primarily of supportive or clarifying comments from industry groups. The State addresses the comments in its submittal included in the docket for this proposal. The State provided public notice on the March 7, 2019, SIP revision from August 1, 2018, to October 4, 2018, and held a public hearing on September 27, 2018. During the public comment period, the State received nine comments, seven of which were from EPA. The State addresses the comments in its submittal. Further discussion of the state responses to comments received is included in the TSD and the state submittal documents in the docket. In addition, as explained above and in the TSD, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

The EPA proposes to approve the revisions to 10 CSR 10-6.220 as requested by Missouri in submissions dated November 29, 2016 and March 7, 2019. We are soliciting comments on this proposed action. We are soliciting comments solely on the proposed revisions to the rule and not on the existing text that is approved into Missouri's SIP. Final rulemaking will occur after consideration of any comments.

Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

The state did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. While EPA did not perform an area-specific EJ analysis for purposes of this action, due to the nature of the action being taken here, i.e. to remove an exemption for excess emissions during periods of SSM and add exemptions for sources subject to equivalent or more stringent limits, as explained in this preamble and the technical support document in this docket, this action is expected to have a neutral to positive impact on air quality. Because consideration of EJ is not required as part of this action, there is no information in the record inconsistent with the stated goals of E.O 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.

This action approves revisions to a Missouri state rule concerning visible emissions. As explained in the preamble and technical support document, the emissions change associated with the revisions requested by Missouri is expected to be small if any. Therefore, we expect that this action will not interfere with attainment or maintenance of the NAAQS, reasonable further progress, or other CAA requirements. For these reasons, this action is not expected to have a disproportionately high or adverse human health or environmental effects on a particular group of people.

In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Missouri Regulations discussed in Section III of this preamble and as set forth below in the proposed amendments to 40 CFR part 52. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 7 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

• This action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The basis for this determination is contained in Section VI of this action, “Environmental Justice Concerns.”

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:

Table of Contents I. Executive Summary II. Background III. Incorporation by Reference Discussion Under 1 CFR Part 51 IV. Overview of Proposed Amendments A. Amendments To Harmonize With the 2012 SSR-6 and 2018 SSR-6, Rev. 1 B. Other Proposed Amendments C. Amendments Not Being Considered for Proposal V. Section-by-Section Review VI. Regulatory Analyses and Notices A. Statutory/Legal Authority B. Executive Order 12866 and DOT Regulatory Policies and Procedures C. Executive Order 13132 D. Executive Order 13175 E. Regulatory Flexibility Act and Executive Order 13272 F. Paperwork Reduction Act G. Unfunded Mandates Reform Act of 1995 H. Environmental Assessment I. Privacy Act J. Executive Order 13609 and International Trade Analysis K. Executive Order 12898 and Environmental Justice L. National Technology Transfer and Advancement Act I. Executive Summary

PHMSA, in coordination with the Nuclear Regulatory Commission (NRC), proposes to amend certain provisions of the Hazardous Materials Regulations (HMR; 49 CFR parts 171 to 180) to maintain alignment with International Atomic Energy Agency (IAEA) regulations and standards. Additionally, PHMSA proposes regulatory amendments identified through internal regulatory review processes to update, clarify, correct, or streamline certain regulatory requirements applicable to the transportation of Class 7 radioactive materials.

PHMSA expects adoption of the regulatory amendments proposed in this NPRM will maintain the high safety standard currently achieved under the HMR. PHMSA also notes that—insofar as harmonization of the HMR with international consensus standards as proposed could reduce delays and interruptions of hazardous materials shipments during transportation—the proposed amendments may also lower greenhouse gas (GHG) emissions and safety risks to minority, low-income, underserved, and other disadvantaged populations, and communities in the vicinity of interim storage sites and transportation arteries and hubs.

The following list summarizes the more noteworthy proposals set forth in this NPRM:

• Incorporation by Reference: PHMSA proposes to incorporate by reference IAEA's 2018 Edition of Regulations for the Safe Transport of Radioactive Material, Safety Standards Series No. SSR-6 (Rev.1); American National Standard Institute's (ANSI) N14.1 Uranium Hexafluoride—Packaging for Transport, 2012 Edition; and ANSI's N14.1 Uranium Hexafluoride—Packaging for Transport, 2019 Edition.

• Scope and Applicability of Subpart I (Radioactive Materials Packaging Requirements): PHMSA proposes to except certain shipments from the requirements of subpart I of the HMR by amending § 173.401. First, PHMSA proposes to amend § 173.401(b)(4) to specify that § 173.401 does not apply to all natural material and ores containing naturally-occurring radionuclides regardless of the intended use, provided the activity concentration of the material does not exceed 10 times the exempt material activity concentration values specified in § 173.436, or as determined in accordance with the requirements of § 173.433. Currently, only natural materials and ores processed for purposes other than extraction of the radionuclides are excepted in § 173.401(b). As written, the HMR treats identical radioactive materials differently based on the intended use and not the hazard presented. Second, PHMSA proposes to revise § 173.401(b)(2) to provide an exception for a person being transported for medical treatment because of accidental or deliberate intake of radioactive material, or because of contamination. Currently, § 173.401 provides an exception from subpart I for radioactive materials implanted into people or animals for diagnosis or treatment, but not for radioactive material present in or on an individual due to contamination. The second proposed amendment would address these additional circumstances and facilitate the transportation of people and their effects—such as clothing or other items on their person—who have been contaminated and need to be transported for medical treatment.

• Surface Contaminated Object—III (SCO-III): PHMSA proposes to revise the definition for “Surface Contaminated Object” (SCO) in § 173.403 to include “SCO-III.” This new form of surface contaminated object is meant for large solid objects ( e.g., a steam generator, reactor coolant pump, pressurizer, or reactor head component, etc.) that cannot be transported in a package. The requirements for transporting SCO-III material are proposed in § 173.427. Currently, such shipments can only be transported using a DOT special permit.

• Aging of Packages: PHMSA proposes to amend § 173.410 to require package manufacturers to consider the effects of aging during the design process. The proposed language requires manufacturers to evaluate the potential degradation phenomena over time, such as corrosion, abrasion, fatigue, crack propagation, changes of material compositions or mechanical properties due to thermal loadings or radiation, generation of decomposition gas, as well as their impact on the functions important to safety. Package engineers already consider these factors when they design radioactive packages; however, there is no specific requirement related to the aging of packaging designs. The codification of this best practice would help to ensure that radioactive packagings remain safe throughout their life cycle.

PHMSA expects that some of the proposed amendments represent improvements in safety— e.g., transport index limits and packaging aging—while none would have significant negative impacts on public safety or the environment. Additionally, PHMSA anticipates safety benefits from improved compliance related to consistency between domestic and international regulations. PHMSA solicits comment on the amendments proposed in this NPRM, specifically the: (1) need for the proposals, including benefits and costs of those actions; (2) potential impacts on safety and the environment; impact on environmental justice and equity; and (3) any other relevant information. In addition, PHMSA solicits comment regarding approaches to reducing the costs of this rulemaking while maintaining or increasing safety benefits. In its preliminary regulatory impact analysis (PRIA), PHMSA concluded that the aggregate benefits of the amendments proposed in this NPRM justify their aggregate costs. Nonetheless, PHMSA solicits comment on specific changes ( e.g., greater flexibility for a particular proposal) that might improve the safe transportation of radioactive materials.

The Federal Hazardous Materials Transportation Act (codified at 49 U.S.C. 5101 et seq. ) directs PHMSA to participate in relevant international standard-setting bodies and encourages alignment of the HMR with international transport standards consistent with the promotion of safety and the public interest. 1 This statutory mandate reflects the importance of international standard-setting activity when considering the globalization of commercial transportation of hazardous materials. Harmonization of the HMR with international transport standards, as appropriate, can reduce the costs and other burdens of complying with multiple or inconsistent safety requirements. Consistency between the HMR and current international standards can also enhance safety by: (1) ensuring that the HMR is informed by the latest best practices and lessons learned; (2) improving understanding of and compliance with pertinent requirements; (3) facilitating the smooth flow of hazardous materials from their points of origin to their points of destination, thereby avoiding risks to the public and the environment from the release of hazardous materials due to delays or interruptions in the transportation of those materials; and (4) enabling consistent emergency response procedures in the event of a hazardous materials incident.

Under their respective statutory authorities, PHMSA and the NRC jointly regulate the transportation of radioactive materials to, from, and within the United States. In accordance with the 1979 Memorandum of Understanding (MOU)  2 between DOT and NRC:

• PHMSA regulates both shippers and carriers with respect to:

○ packaging requirements;

○ communication requirements for:

shipping paper contents;

package labeling and marking;

vehicle placarding; and

○ training and emergency response requirements.

• NRC requires its licensees to satisfy requirements to protect public health and safety, to assure the common defense and security, and:

○ certifies Type B and fissile material package designs and approves package quality assurance programs for its licensees;

○ provides technical support to PHMSA and works with PHMSA to ensure consistency with respect to the transportation of Class 7 (radioactive) materials; and

○ conducts inspections of licensees and an enforcement program within its jurisdiction to assure compliance with its requirements.

Historically, PHMSA and NRC—and their predecessor agencies—have, to the extent practicable, harmonized their respective regulations to maintain compatibility with the IAEA's regulations. The Safety Series No. 6, “Regulations for the Safe Transport of Radioactive Material,” was first published by IAEA in 1961 and revised in 1964, and again in 1967. On October 4, 1968, DOT adopted harmonizing amendments to the HMR. 3 Additional revisions were made by IAEA in 1973 and 1985, and DOT then codified these revisions in the HMR. 4 IAEA completed a major revision to the Safety Series No. 6—renamed “Regulations for the Safe Transport of Radioactive Material, 1996 Edition, No. ST-1”—in 1996 and later republished it in 2000 to include minor editorial changes, at which time the previous designation was changed to “Regulations for the Safe Transport of Radioactive Material, 1996 Edition, No. TS-R-1, (ST-1, Revised).” On January 26, 2004, PHMSA adopted harmonizing amendments to the HMR. 5 Then, on July 11, 2014, PHMSA adopted the updates of the 2003, 2005 and 2009 editions in the HMR. 6 Finally, on January 8, 2015, PHMSA incorporated by reference the 2012 edition of the SSR, 7 but did not fully harmonize the HMR's requirements with the changes made in that edition.

In this NPRM, PHMSA proposes to amend the HMR to align with the sections of 2012 SSR-6 the HMR do not currently harmonize with and 2018 SSR-6, (Rev. 1), which includes changes made to the IAEA regulations since PHMSA's rulemaking in 2014. 8 Furthermore, PHMSA proposes to incorporate by reference 2018 SSR-6, (Rev. 1) and the 2012 and 2019 editions of ANSI N14.1: Uranium Hexafluoride—Packaging for Transport. Additionally, PHMSA proposes regulatory amendments identified through internal regulatory review processes to update, clarify, correct, or streamline certain regulatory requirements applicable to the transportation of Class 7 (radioactive) materials.

PHMSA is working closely with NRC in the development of this rulemaking and anticipates that NRC will publish a parallel rulemaking. PHMSA and NRC will coordinate the development and publication schedules for the final rules and, if necessary, PHMSA may issue a supplemental notice of proposed rulemaking to ensure that the DOT and NRC rules are compatible.

This NPRM addresses only the areas for which DOT has jurisdiction as defined in the MOU with NRC. Comments responding to any parallel NRC NPRM should be submitted in accordance with the public participation guidelines established by NRC in 10 CFR part 2 subpart H.

According to the Office of Management and Budget's (OMB) Circular A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities,” government agencies must use voluntary consensus standards wherever practical in the development of regulations.

PHMSA currently incorporates by reference into the HMR all or the relevant parts of several standards and specifications developed and published by standard development organizations (SDO). In general, SDOs update and revise their published standards every two to five years to reflect modern technology and best technical practices. The National Technology Transfer and Advancement Act of 1995 (NTTAA; Pub. L. 104-113) directs Federal agencies to use standards developed by voluntary consensus standards bodies in lieu of government-written standards unless to do so would be inconsistent with applicable law or otherwise impracticable. Voluntary consensus standards bodies develop, establish, or coordinate technical standards using agreed-upon procedures. OMB issued Circular A-119 to implement section 12(d) of the NTTAA relative to the utilization of consensus technical standards by Federal agencies. This circular provides guidance for agencies participating in voluntary consensus standards bodies and describes procedures for satisfying the reporting requirements in the NTTAA. Consistent with the requirements of the NTTAA and its statutory authorities, PHMSA is responsible for determining which standards should be updated, revised, removed, or added to the HMR. Revisions to materials incorporated by reference in the HMR are handled via the rulemaking process, which allows the public and regulated entities to provide input. During the rulemaking process, PHMSA must also obtain approval from the Office of the Federal Register to incorporate by reference any new materials. Regulations of the Office of the Federal Register require that agencies detail in the preamble of an NPRM the ways the materials it proposes to incorporate by reference are reasonably available to interested parties, or how the agency worked to make those materials reasonably available to interested parties. ( See 1 CFR 51.5.)

PHMSA proposes to incorporate by reference “Specific Safety Requirements Number SSR-6, Revision 1: Regulations for the Safe Transport of Radioactive Material 2018 Edition” (2018 SSR-6, Rev. 1) and the 2012 and 2019 editions of ANSI N14.1: Uranium Hexafluoride—Packaging for Transport. A summary and discussion of these standards can be found in “V. Section-by-Section Review” under § 171.7. The IAEA regulations are free and easily accessible to the public on the internet, with access provided through the parent organization website at: https://www.iaea.org/publications/12288/regulations-for-the-safe-transport-of-radioactive-material. The 2012 and 2019 editions of ANSI N14.1 are available for purchase on the ANSI website at: https://webstore.ansi.org/Standards/PCC/ANSIN142012 and https://webstore.ansi.org/Standards/PCC/ANSIN142019 respectively.

PHMSA proposes amendments to the HMR based on updates to the 2012 and 2018 editions of the IAEA Safety Standards: 2012 SSR-6 and 2018 SSR-6, Rev. 1. As proposed, the amendments would continue to maintain compatibility between the HMR and the IAEA regulations. PHMSA does not intend to make the HMR identical to the IAEA regulations but, rather, to remove or avoid potential barriers to international commerce while adhering to domestic law, reflecting domestic practices, and maintaining public health and safety. Accordingly, PHMSA is not proposing to adopt all the recent updates into the HMR because the framework or structure of the HMR may make adoption unnecessary or impractical. In such cases, there is no added benefit to safety that might outweigh the impracticality of adoption.

In consideration of updates in 2012 SSR-6 and 2018 SSR-6, Rev. 1, PHMSA proposes to amend the HMR as follows:

• Revise paragraph § 171.7(s) to incorporate by reference the revised 2018 SSR-6, Rev. 1 into the HMR.

• Revise § 172.101 to add the new SCO-III, so that the proper shipping name of UN2913 reads “Radioactive Material, surface contaminated objects (SCO-I, SCO-II, or SCO-III) in the Hazardous Materials Table (HMT).

• Add new language to § 172.203(d)(4) and (5) to allow for the label type and transport index of overpacks to be listed on shipping papers.

• Clarify § 172.310 to state that markings on a package that do not relate to the material in the package must be removed or covered before shipment.

• Add a provision to § 173.401(b)(2) to include persons contaminated by radioactive material transported for medical treatment.

• Add a new term “dose rate” in § 173.403.

• Revise the definition of Low specific activity (LSA) material in § 173.403 to remove the leaching prevention requirement for LSA-III material.

• Revise the definition of Special Form Class 7 (radioactive) in § 173.403 to adopt a newer standard for the design of these materials.

• Revise the definition of Surface Contaminated Object (SCO) in § 173.403 to add a new SCO-III material.

• Revise § 173.410(i)(3) to require that all Class 7 materials—not just liquids—be capable of withstanding an internal pressure that produces a pressure differential of not less than the maximum normal operating pressure plus 95 kPa.

• Add a new paragraph (j) to § 173.410 to require that aging be considered when designing packages for Class 7 materials.

• Amend § 173.417(a) to allow the import and export of fissile material packages that meet IAEA requirements for criticality safety index control without package certification by Competent Authorities.

• Add requirements to § 173.427 for the new SCO-III materials, including a new § 173.427(d) to require vehicles transporting the new SCO-III materials be properly surveyed for residual radioactivity after each shipment.

• Add a new paragraph (i) to § 173.433 to allow a stakeholder to apply for an approval to allow certain instruments or articles to have an alternative activity limit.

• Add seven new radionuclides to the Table of A 1 and A 2 values for radionuclides. in § 173.435.

• Add seven new radionuclides to the Table of Exempt material activity concentrations and exempt consignment activity limits for radionuclides in § 173.436.

• Add reference in § 173.443 to the new § 173.427(d) to require vehicles transporting the new SCO-III materials be properly surveyed for residual radioactivity after each shipment.

• Revise § 173.448 to require overpacks to be marked with the name and address of the consigner and consignee if this information cannot be seen on the packages.

• Amend § 173.453(d) to add another condition to the existing exception to require fissile material be distributed homogeneously and not form a lattice arrangement within the package.

• Add a new paragraph (g) to § 173.453 to allow a fissile material exception for packages containing up to 3.5 grams of uranium-235 where the uranium-235 is not more than 5 percent of the material.

• Add a new paragraph (h) to § 173.453 to allow an exception for up to 140 grams fissile nuclides when shipped under exclusive use.

• Add a new paragraph (j) to § 173.475 to require proper maintenance of shipments of Class 7 materials while in storage.

In addition to the amendments proposed for harmonization with 2012 SSR-6 and 2018 SSR-6, Rev. 1, PHMSA proposes the following regulatory amendments identified through internal regulatory review processes to update, clarify, correct, or streamline certain regulatory requirements applicable to the transportation of Class 7 (radioactive) materials:

• Revise paragraph (d) of § 171.7 to remove reference to § 173.417 and add the 2012 and 2019 editions of ANSI N14.1: Uranium Hexafluoride—Packaging for Transport.

• Amend the § 172.101 HMT to remove the reference to § 173.427 from columns 8B and 8C for “UN2978, Radioactive material, uranium hexafluoride.”

• Amend § 172.102(c)(1) to remove the reference to § 173.472, which is proposed to be deleted.

• Amend paragraph (d) of § 172.203 to require a list of the fissile nuclides contained in a package be included on a shipping paper.

• Add new language to § 173.415 to clarify documentation requirements.

• Add new language to § 173.417 to provide a provision for fissile material when offered for import or export.

• Add new language to § 173.420 to reference § 173.477 which is the relevant packaging section for the material.

• Add new language to § 173.420 to reference § 171.7 where American National Standard N14.1 is referenced.

• Revise § 173.424 to correct a referenced section and allow transport of packages that contain fissile material only if excepted by § 173.453.

• Revise § 173.431(b) to remove the reference to § 173.472, which is proposed to be deleted.

• Add a clarification to footnote “b” of § 173.436 to state that in the case of Th-natural, the parent nuclide is Th-232, and in the case of U-natural the parent nuclide is U-238.

• Add a new paragraph to § 173.447. Paragraph (b) will be redesignated as (c), and new paragraph (b) will be added, which will limit groups of Class 7 (radioactive) packages to a transport index of 50 and require a minimum distance of 6 meters (20ft) between groups of packages.

• Remove § 173.472 because Type B packages were previously removed from the HMR.

• Revise the leakage and contamination sections of the modal-specific requirements, specifically—§§ 174.750, 175.705, 176.715, and 177.843—to reference the existing § 173.443(e).

PHMSA is not proposing to adopt all the updates made to the IAEA regulations since 2012 into the HMR. In many cases, amendments to the IAEA standards are not proposed for adoption because the framework or structure of the HMR makes adoption unnecessary or impractical. Below is a listing of significant amendments to the IAEA regulations made since PHMSA's 2014 rulemaking that are not being proposed for adoption at this time.

• PHMSA is not replacing the term “radiation level” with “dose rate” throughout the HMR because the term “dose rate” is already used in the HMR as a synonym for “radiation level.” Instead, PHMSA proposes to add a definition for “dose rate” that will duplicate the current HMR definition for “radiation level.”

• PHMSA is not adopting all of the changes in the IAEA fissile material exceptions in SSR-6 paragraphs 417 and 674 for material shipped with beryllium, hydrogenous material enriched in deuterium, graphite, and other allotropic forms of carbon (except for international shipments), and paragraph 675, which exempted certain plutonium shipments from some packaging requirements. Instead, PHMSA proposes to adopt changes consistent with the changes that NRC has identified in the Regulatory Basis for NRC Docket 2016-0179.

Section 171.7 provides a listing of all voluntary consensus standards incorporated by reference into the HMR. PHMSA proposes to incorporate by reference “Specific Safety Requirements Number SSR-6, Revision 1: Regulations for the Safe Transport of Radioactive Material 2018 Edition” (2018 SSR-6, Rev. 1) and the 2012 and 2019 editions of ANSI N14.1: Uranium Hexafluoride—Packaging for Transport. IAEA's SSR-6 Rev.1 regulates the transportation of radioactive materials internationally. PHMSA evaluated the updated standards and determined that the revisions provide an enhanced level of safety without imposing significant compliance burdens. These standards have well-established and documented safety histories, and their adoption will maintain the high safety standard currently achieved under the HMR.

Therefore, PHMSA proposes to add or revise the following incorporation by reference materials:

• In paragraph (d), remove reference to § 173.417 and incorporate by reference the 2012 and 2019 editions of ANSI N14.1: Uranium Hexafluoride—Packaging for Transport in addition to the versions currently listed in § 171.7(d). PHMSA proposes to remove the reference to § 173.417 from this paragraph because § 173.417 does not reference the ANSI N14.1 standard. The language in § 173.417 pertains to shipments of less than 0.1 kg of uranium hexafluoride while ANSI N14.1 only pertains to shipments exceeding 0.1 kg and those requirements are found in the other listed section, see § 173.420. The new editions of ANSI N14.1 provide criteria for packaging uranium hexafluoride for transportation and cover design and fabrication of the packaging, service inspection requirements, cleanliness, maintenance requirements, and cylinder loading requirements. PHMSA has incorporated this standard in its regulations since 1971, and it remains the industry standard for shipping uranium hexafluoride. The changes from the 2001 version to the proposed 2019 version include requirements for the use of “plugs” that were not previously allowed and provisions for converting imperial units to metric, as well as harmonization with the 2018 SSR-6, Rev. 1 and additional best practices including incorporating standards from ASTM International. PHMSA believes that the 2019 edition adds an increased level of safety by bringing in updated safety requirements, while allowing more flexibility in packaging. While the 2019 edition of ANSI N14.1 will be the required standard for new uranium hexafluoride packages, older packages may remain in service provided that repairs, markings, and periodic tests and inspections comply with the 2019 edition. The changes to the inspection, testing, and repair requirements between the 2001 and 2019 editions are largely formatting changes, and PHMSA does not believe that the revisions will necessitate the removal of existing packaging from circulation. Further, by incorporating both the proposed editions, packages built to the 2012 edition will be permitted in accordance with § 173.420. However, new packages will still need to be manufactured to the 2019 standard. The ANSI N14.1: Uranium Hexafluoride—Packaging for Transport 2012 and 2019 editions are available for purchase at the following websites:

The Convention is concerned with the conservation and management of highly migratory species (HMS) and the management of fisheries for HMS. The objective of the Convention is to ensure, through effective management, the long-term conservation and sustainable use of HMS in the western and central Pacific Ocean (WCPO). To accomplish this objective, the Convention established the Commission, which includes Members, Cooperating Non-members, and Participating Territories (collectively referred to here as “members”). The United States of America is a Member. American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands are Participating Territories.

As a Contracting Party to the Convention and a Member of the Commission, the United States implements, as appropriate, conservation and management measures adopted by the Commission and other decisions of the Commission. The Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA; 16 U.S.C. 6901 et seq. ), authorizes the Secretary of Commerce, in consultation with the Secretary of State and the Secretary of the Department in which the United States Coast Guard is operating (the Department of Homeland Security), to promulgate such regulations as may be necessary to carry out the obligations of the United States under the Convention, including the decisions of the Commission. The WCPFC Implementation Act further provides that the Secretary of Commerce shall ensure consistency, to the extent practicable, of fishery management programs administered under the WCPFC Implementation Act and the Magnuson-Stevens Fishery Conservation and Management Act (MSA; 16 U.S.C. 1801 et seq. ), as well as other specific laws (see 16 U.S.C. 6905(b)). The Secretary of Commerce has delegated the authority to promulgate regulations under the WCPFC Implementation Act to NMFS. A map showing the boundaries of the area of application of the Convention (Convention Area), which comprises the majority of the WCPO, can be found on the WCPFC website at: www.wcpfc.int/doc/convention-area-map.

At its Fourteenth Regular Session, in December 2017, the Commission adopted Conservation and Management Measure (CMM) 2017-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean.” CMM 2017-01 included provisions for purse seine fishing effort limits, restrictions on the use of fish aggregating devices (FAD) for purse seine fishing vessels, specific catch retention provisions for purse seine fishing vessels, and longline bigeye tuna catch limits, among others. At its Fifteenth Regular Session, in December 2018, the Commission adopted Conservation and Management Measure (CMM) 2018-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean,” which replaced CMM 2017-01 but included similar provisions. CMM 2018-01 went into effect on February 13, 2019, and remained in effect until February 10, 2021. At its Seventeenth Regular Session, in December 2020, the Commission adopted CMM 2020-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean,” which are identical to those of 2018-01, and were in effect until February 15, 2022. At its Eighteenth Regular Session, in December 2021, the Commission adopted CMM 2021-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean,” which is effective until February 15, 2024. These and other CMMs are available at: www.wcpfc.int/conservation-and-management-measures. NMFS has implemented through other rulemakings the other relevant provisions of CMM 2021-01. 1 The previous rules pertinent to the measure's purse seine fishing effort limits and longline bigeye tuna catch limits are described below.

By interim final rule published in the Federal Register on July 31, 2019, NMFS implemented CMM 2018-01's provisions regarding the limits on fishing effort by U.S. purse seine vessels in the U.S. EEZ and on the high seas between the latitudes of 20° N and 20° S in the Convention Area (see 84 FR 37145; hereafter 2019 interim final rule). In that rule, NMFS established a combined limit on fishing effort by U.S. purse seine vessels in the Effort Limit Area for Purse Seine (or ELAPS, which comprises the areas of the high seas and U.S. EEZ between 20° N latitude and 20° S latitude in the Convention Area) of 1,828 fishing days  2 per year for 2020 and subsequent years. These regulations are in effect until they are amended, replaced, or repealed (see 50 CFR 300.223(a)).

CMM 2021-01 and its predecessor CMMs include language that requires any overage of an annual purse seine fishing effort limit to be deducted from the limit for the following year. As stated in the 2019 interim final rule, NMFS combined the purse seine fishing effort limits for the U.S. EEZ and the high seas, consistent with previous rulemakings. For 2019, the interim final rule established a limit of 1,616 fishing days (558 fishing days from the U.S. EEZ limit plus 1,270 days from the high seas limit less the 212 fishing day overage of the 2018 high seas limit) for the ELAPS. For 2020 and subsequent years, the 2019 interim final rule established a limit of 1,828 fishing days per calendar year for the ELAPS.

In 2020, the U.S. purse seine fleet used 126 fishing days in the U.S. EEZ and 1,659 fishing days in the high seas, and in 2021, the fleet used 118 fishing days in the U.S. EEZ and 733 fishing days in the high seas. Thus, the fleet did not exceed the ELAPS limit established by NMFS or the WCPFC-specified U.S. EEZ limit in either 2020 or 2021. However, in 2020, the fleet did exceed the WCPFC-specified high seas fishing day limit by 329 fishing days. Thus, the WCPFC-specified fishing day limit for U.S. purse seine vessels on the high seas in 2021 was 1,270 fishing days minus the 329 fishing day overage, or 881 fishing days. As stated, the U.S. purse seine fleet used 773 fishing days on the high seas in 2021—fewer fishing days than 881 fishing days.

NMFS is issuing this proposed rule to amend the existing regulations to establish separate purse seine fishing effort limits for the U.S. EEZ and for the high seas. The limit for the U.S. EEZ established by the Commission in CMM 2021-01 is 558 fishing days per year. The limit for the high seas established by the Commission in CMM 2021-01 is 1,270 fishing days per year. NMFS has established combined limits for the ELAPS in previous years to provide increased operational flexibility to the U.S. purse seine fleet fishing in the WCPO. In the past, NMFS combined the limits because it provided for operational flexibility while having the same overall impact on the stock. However, other WCPFC members have vigorously objected to the U.S. approach, and NMFS acknowledges that the plain text of the CMM establishes separate U.S. EEZ and high seas limits. NMFS also notes that there are significantly fewer licensed U.S. vessels operating under these limits, reducing the risk that separate limits will be exceeded. Without necessarily conceding that the CMM prohibits a member's discretion to enforce a combined limit provided that the total amount harvested does not exceed the sum of the EEZ and high seas limits, NMFS declines to depart from the plain language of the CMM. Accordingly, NMFS proposes to establish separate U.S. EEZ and high seas limits. NMFS would implement the limits in this proposed rule to remain effective until they are replaced or amended.

NMFS is also implementing the overage provision in CMM 2021-01 by including specific regulatory language indicating that NMFS would adjust the annual U.S. EEZ and high seas purse seine fishing effort limits each year to account for any overage of the limits in the previous year.

By final rule published in the Federal Register on July 18, 2018 (83 FR 33851), NMFS implemented the longline bigeye tuna catch limit specified in CMM 2017-01 for U.S. commercial fishing vessels fishing in the Convention Area. The limit is 3,554 mt of bigeye tuna per year for longline fishing vessels of the United States (see 50 CFR 300.224(a)). The limit has remained the same in the more recent WCPFC decisions on tropical tunas, and is the same under the tropical tunas decision currently in effect—CMM 2021-01. Under WCPFC decisions on tropical tunas, if the limit is exceeded in a given year, the following year's limit must account for that overage (see CMM 2021-01 at Paragraph 37). The 2021 U.S. longline bigeye tuna catch in the Convention Area was 3,750 mt or 196 mt over the catch limit. Thus, under this proposed rule, the 2022 U.S longline bigeye tuna catch limit in the Convention Area would be adjusted to 3,358 mt. The limit for 2023 and future years would be maintained at 3,554 mt. However, NMFS is also implementing the overage provision in CMM 2021-01 by including specific regulatory language indicating that NMFS would adjust the annual limit in each year to account for any overage of the previous year's limit.

Currently, NMFS estimates the number of fishing days spent on the high seas and in the U.S. EEZ by the U.S. purse seine fleet in each calendar year using logbooks and other available information. If NMFS determines that the fishing day limit is going to be reached in any given year, NMFS will issue a closure notice and U.S. purse seine vessels will be prohibited from fishing in those areas for the remainder of the calendar year. Existing regulations under 50 CFR 300.223(a) establish that NMFS will publish the closure notice in the Federal Register at least seven calendar days in advance of the closure date. This proposed rule would modify the existing regulations.

This proposed rule would amend the existing regulations to remove the requirement for NMFS to publish the fishery closure notice in the Federal Register seven days in advance of a closure. Instead, NMFS would publish the annual limits and estimates of the fishing effort on a NMFS web page on a periodic basis, and use the web page as well as direct email communication with vessel owners to provide notification of a fishery closure. NMFS would publish a notification of the fishery closure in the Federal Register as soon as possible. The details of this element of the proposed rule are included in the description of the proposed action section below. By reducing the administrative time necessary to publish in the Federal Register 7 days in advance of a closure and the specific time needed for advance notice to industry, NMFS would be able to more closely align the closure date to the date the limit is actually reached, thereby reducing the magnitude of overages (in the case of exceeding the limit upon the closure date) and underages (in the case of not reaching the limit upon the closure date).

As stated in existing regulations at 50 CFR 300.223(a)(4), starting on the announced closure date, and for the remainder of calendar year, it would be prohibited for U.S. purse seine vessels to fish in the U.S. EEZ or the high seas, except that such vessels would not be prohibited from bunkering during the closure. This proposed rule would not affect the prohibitions in place once the U.S. EEZ or high seas is closed.

The regulations at 50 CFR 300.218(g) states as follows: if directed by NMFS, the owner or operator of any fishing vessel of the United States equipped with purse seine gear must report to NMFS, in a specified format and manner, the activity of the vessel in the Convention Area  3 ( e.g., setting, transiting, searching), location and type of set, if a set was made during that day. NMFS has been directing vessel owners or operators to provide these daily purse seine fishing effort reports for a number of years in order to collect data to better track purse seine fishing effort limits. Because NMFS believes that these reports provide valuable information on purse seine fishing effort, NMFS is proposing to require vessel owners/operators to provide daily fishing effort reports (instead of only when directed by NMFS). However, the current directive to provide these reports requires vessel owners and operators to provide these reports continually, so in practice, this element of the rule would not affect what vessel owners and operators are currently doing.

As discussed above, NMFS is implementing the overage provisions of CMM 2021-01 for the purse seine fishing effort limits and the longline bigeye tuna catch limits in the regulations at 50 CFR 300.223(a) and 50 CFR 300.224(a), respectively. NMFS would adjust these limits downward in a given year to account for overages of the prior year's limits. The regulations at 50 CFR 300.227 set forth a framework process through which NMFS may specify particular WCPFC catch and effort limits on an annual basis. Under the process, NMFS may publish a notice of the catch or effort limit in the Federal Register for public comment instead of modifying existing codified regulations or issuing new regulations, which allows NMFS to implement such limits more quickly. Limits established under that process must remain in effect for less than one year. Under this proposed rule, NMFS would modify the regulations at 50 CFR 300.227 so that adjustments to codified catch or fishing effort limits in the Convention Area on an annual basis would be made through the framework process specified in those regulations. NMFS would also clarify that limits established through that framework process must remain in effect for less than one year. This modification would allow NMFS to adjust existing catch and effort limits on an annual basis to account for overages of such limits in prior years.

This proposed rule includes the following elements: (1) modification of purse seine fishing effort limits; (2) adjustment to the 2022 longline bigeye tuna catch limits; (3) modification of the process for closing the purse seine fishery once an effort limit is reached; (4) modification of the purse seine daily fishing effort reporting requirements, and (5) modification of the regulations at 50 CFR 300.227 to include annual adjustments to existing catch and effort limits.

This proposed rule would establish a limit of 558 fishing days for the U.S. EEZ and 1,270 fishing days for the high seas for 2022 and subsequent years. These limits are subject to adjustment under the procedures in 300.227(f) for any overage of a previous year's limits.

This proposed rule would adjust the longline bigeye tuna catch limits for 2022 to 3,358 mt. The limit for 2023 and future years would remain at 3,554 mt. That limit is subject to adjustment under the procedures in 200.227(f) for any overage of a previous year's limit.

This proposed rule would amend the existing regulations at 50 CFR 300.223(a)(3) to remove the requirement for NMFS to publish the fishery closure notice in the Federal Register 7 days in advance of a closure. NMFS intends to publish the annual limits and estimates of the fishing effort expended on a NMFS website and provide updates on a periodic basis. Under this proposed rule, once NMFS determines that a limit is expected to be reached, NMFS would post the notice on a NMFS web page  4 announcing the fishery closure date and would also email notice of the closure date to affected vessel owners reducing the processing time for announcing the closure. NMFS also would publish the closure notice in the Federal Register , as soon as practicable. The closure would be effective upon the earlier of either (1) receipt by email of such notice, or (2) publication in the Federal Register .

As stated in existing regulations at 50 CFR 300.223(a)(4), starting on the announced closure date, and for the remainder of calendar year, it would be prohibited for U.S. purse seine vessels to fish in the U.S. EEZ or the high seas, except that such vessels would not be prohibited from bunkering during the closure. This proposed rule would not affect the prohibitions in place once the U.S. EEZ or high seas is closed.

As described above, under this proposed rule, NMFS proposes to modify the language in 50 CFR 300.218(g) so that the daily purse seine fishing effort reporting would be required. However, the current directive to provide these reports requires vessel owners and operators to provide these reports continually, so in practice, this element of the rule would not affect what vessel owners and operators are currently doing.

Under this proposed rule, NMFS would modify the regulations at 50 CFR 300.227 so that the framework process to issue catch and effort limits would be used to adjust codified catch and effort limits that implement WCPFC decisions, as appropriate. Under the process, NMFS would publish a notice of the adjusted catch or effort limit in the Federal Register for public comment instead of modifying existing codified regulations or issuing new regulations. NMFS would also modify the regulations at 50 CFR 300.227 to clarify that any limits established under the framework process must remain in effect for less than one year.

The Administrator, Pacific Islands Region, NMFS, has determined that this proposed rule is consistent with the WCPFC Implementation Act and other applicable laws, subject to further consideration after public comment.

NMFS determined that implementation of the purse seine fishing effort limits, modifications to the process for closing the fishery once an effort limit is reached, and modifications to the process related to collecting daily purse seine fishing effort reports are consistent to the maximum extent practicable with the enforceable policies of the approved coastal management program of American Samoa, the Commonwealth of the Northern Mariana Islands (CNMI), Guam, and the State of Hawaii. Determinations to Hawaii, American Samoa, CNMI and Guam were submitted on March 23, 2022, for review by the responsible state and territorial agencies under section 307 of the CZMA.

The state of Hawaii responded by letter dated March 28, 2022, that for this particular proposal, because the U.S. WCPO purse seine fishery operates outside of the jurisdiction of Hawaii CZM Program enforceable policies, it would not be responding to the consistency determination. In addition, the state of Hawaii agreed to an alternative Federal consistency notification schedule that ended on the date of the March 28, 2022, letter. CNMI provided concurrence with the consistency determination on April 28, 2022.

NMFS determined that the U.S. longline bigeye tuna catch limit of 3,554 mt was consistent to the maximum extent practicable with the enforceable policies of the approved coastal management program of American Samoa, CNMI, Guam, and the State of Hawaii in 2018 when it established this limit (83 FR 33851; July 18, 2018). NMFS received no objections from the state/territorial agencies on this determination. Because the adjustment to the limit under this proposed rule would not lead to any new effects on coastal areas or resources than what were evaluated in the 2018 consistency determinations, no new determinations have been prepared for this element of the proposed rule.

Modifications to the framework process in the regulations at 50 CFR 300.227 would be administrative in nature and not expected to cause any effects on coastal areas or resources.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the RFA. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained in the SUMMARY section of the preamble. The analysis follows:

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 114111) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

The proposed rule would apply to owners and operators of U.S. commercial fishing vessels used to fish for HMS in the Convention Area, including longline vessels (except those operating as part of the longline fisheries of American Samoa, CNMI, or Guam) and purse seine vessels. The estimated number of affected fishing vessels is 151 longline and 15 purse seine vessels, and is based on the number of vessels with those vessel types that hold WCPFC Area Endorsements, which are required to fish on the high seas of the Convention Area, as of May 2, 2022.

Based on (limited) financial information about the affected fishing fleet, and using individual vessels as proxies for individual businesses, NMFS believes that all of the affected longline vessels and 80 percent of the vessels in the purse seine fleet, are small entities as defined by the RFA; that is, they are independently owned and operated and not dominant in their fields of operation, and have annual receipts of no more than $11.0 million. Within the purse seine fleet, analysis of average revenue, by vessel, for 2019-2021 reveals that average annual revenue among vessels in the fleet was about $8 million (NMFS unpublished data combined with price data from https://www.ffa.int/node/425 and https://investor.thaiunion.com/raw_material.html accessed on March 23, 2022), and 12 participating vessels qualified as small entities, with estimated vessel revenue of less than $11 million (based on the average revenue across the most recent three years for which data is available).

The elements of this proposed rule are described earlier in the preamble. The classes of small entities subject to the requirements and the types of professional skills necessary to fulfill the requirements are listed below for each element:

There would be annual limits of 1,270 and 558 fishing days on the high seas and in the U.S. EEZ, respectively, in the Convention Area.

Fulfillment of this element's requirements is not expected to necessitate any professional skills that the vessel owners and operators do not already possess. The costs of complying with the requirements are described below to the extent possible.

Regarding the fishing effort limits, if and when the fishery on the high seas or in the U.S. EEZ is closed as a result of a limit being reached in any year, owners and operators of U.S. purse seine vessels would have to cease fishing in that area for the remainder of the calendar year. Closure of the fishery in either of those areas could thereby result in foregone fishing opportunities and associated economic losses if the area contains preferred fishing grounds during such a closure. Historical fishing rates in the two areas give a rough indication of the likelihood of the limits being reached.

From 2009 through 2021, no more than 41 percent of the proposed limit of 558 fishing days was ever used in the U.S. EEZ. This history suggests a relatively low likelihood of the proposed EEZ limit being reached in a given year. Furthermore, in 2018, when separate limits were established for the EEZ and high seas, fishing day usage in the U.S. EEZ declined, but did not differ significantly from previous years. Approximately 60 percent of the fleet is authorized to fish in the U.S. EEZ. Six of the 13 vessels currently licensed under the South Pacific Tuna Treaty (SPTT)  5 have fishery endorsements on their U.S. Coast Guard Certificates of Documentation, which are required to fish in the U.S. EEZ, and both of the other two purse seine vessels that hold WCPFC Area Endorsements but do not have South Pacific Tuna Treaty licenses have fishery endorsements. With a separate limit for the U.S. EEZ, these eight vessels of the fleet could take advantage of fishing in the U.S. EEZ more than they have in the past if the high seas are closed to fishing in a given year.

Regarding effort in the high seas from 2009 through 2021, between 33 and 145 percent of the proposed limit of 1,270 fishing days was used, and at least 100 percent was used in seven of the thirteen years. In 3 years, 2015, 2016, and 2019 the high seas and U.S EEZ was closed for part of the year (from June 15 to December 31 in 2015, from September 2 to December 31 in 2016, and from October 9-November 28 and from December 9 to December 31 in 2019) and in 2018, the high seas was closed for part of the year (from September 18 to December 31), so more fishing effort might have occurred in those 4 years were there no limits. In the years that both the high seas and U.S. EEZ were closed, it is possible that some or all of any additional fishing effort might have occurred in the U.S. EEZ rather than on the high seas. Given that the fleet generally uses far fewer fishing days in the U.S. EEZ, it is more likely that most or all of any additional effort would have occurred on the high seas instead of in the U.S. EEZ. This history suggests a substantial likelihood of the proposed high seas limit being reached in a given year. However, the fleet has undergone a steep reduction in size in recent years, and is currently at 15 vessels, a level that is less than half its 2019 size of 33 vessels. NMFS believes the vessels that were previously in the fleet reflagged to other nations for business reasons. This reduction in fleet size increases the number of fishing days available on the high seas for the remaining vessels, and could reduce the likelihood of the proposed high seas limit being reached in any a given year. In 2021, 18 purse seine vessels fished in the Convention Area, and fishing effort in the high seas was 773 fishing days, well below the proposed separate high seas limit of 1,270 fishing days, suggesting a lower likelihood of the proposed limit being reached in any a given year. However, the separate limits that would be implemented under this proposed rule would remove the operational flexibility provided under the combined limits currently in place and increase the possibility of a limit being reached or reached earlier in the year.

Two factors could have a substantial influence on the amount of fishing effort in the U.S. EEZ and on the high seas in a given year: First, the number of fishing days available in foreign waters (the fleet's main fishing grounds) pursuant to the SPTT will influence the incentive to fish outside those waters, including the U.S. EEZ and high seas. Second, El Niño—Southern Oscillation (ENSO) conditions will influence where the best fishing grounds are.

Regarding fishing opportunities in foreign waters, in December 2016, the United States and PIPs agreed upon a revised SPTT, and under this agreement U.S. purse seine fishing businesses can purchase fishing days in the EEZs of the PIPs. There are limits on the number of such “upfront” fishing days that may be purchased. These limits can influence the amount of fishing in other areas, such as the U.S. EEZ and the high seas, as well as the eastern Pacific Ocean (EPO). For example, if the number of available upfront fishing days is relatively small, fishing effort in the U.S. EEZ and/or high seas might be relatively great. In fact, the number of upfront days available for the Kiribati EEZ, which has traditionally constituted important fishing grounds for the U.S. fleet, is notably small—only 300 fishing days per year. However, the SPTT provides for U.S. purse seine fishing businesses to purchase “additional” fishing days through direct bilateral agreements with the PIPs. NMFS cannot project how many additional days will be purchased in any given year, so cannot gauge how the limits on upfront days might influence fishing effort in the U.S. EEZ or on the high seas. Limits on upfront days are therefore not considered here any further.

Regarding ENSO conditions, the eastern areas of the WCPO tend to be comparatively more attractive to the U.S. purse seine fleet during El Niño events, when warm surface water spreads from the western Pacific to the eastern Pacific and large, valuable yellowfin tuna become more vulnerable to purse seine fishing and trade winds lessen in intensity. Consequently, the U.S. EEZ and high seas, much of which is situated in the eastern range of the fleet's fishing grounds, is likely to be more important fishing grounds to the fleet during El Niño events (as compared to neutral or La Niña events). This is supported by there being a statistically significant correlation between annual average per-vessel fishing effort in the ELAPS and the Oceanic Niño Index, a common measure of ENSO conditions, from 2001-2021.

El Niño conditions were present in 2015 and in the first half of 2016, and might have contributed to the relatively high rates of fishing in the U.S. EEZ and high seas in those years. As of March 10, 2022, La Niña conditions were present, and the National Weather Service forecasts that La Nina will continue with about a 50 percent probability during June—August 2022, with a 40-50% chance of La Nina or ENSO-neutral conditions thereafter. Thus ENSO conditions might have a negative influence on fishing in the U.S. EEZ and the high seas in 2022. The influence of ENSO conditions on fishing effort in future years cannot be predicted with any certainty.

Another potentially important factor is that the U.S. EEZ and high seas limits would be competitive limits, so their establishment could cause a “race to fish” in the two areas. That is, vessel operators might seek to take advantage of the limited number of fishing days available in the areas before the limits are reached, and fish harder in the high seas or the U.S. EEZ than they would if there were no limits or if there were a combined U.S. EEZ and high seas limit. On the one hand, any such race-to-fish effect might be reflected in the history of fishing in the high seas and U.S. EEZ, described above. On the other hand, anecdotal information from the fishing industry suggests that the limits might have been internally allocated by the fleet, which might have tempered any race to fish. It is not known whether the industry intends to internally allocate the proposed limits.

In summary, although difficult to predict, either the U.S. EEZ or high seas limits could be reached in any given year, especially the high seas limits. If either limit is reached in a given year, the fleet would be prohibited from fishing in that area for the remainder of the calendar year.

The closure of any fishing grounds for any amount of time can be expected to bring adverse impacts to affected entities ( e.g., because the open area might, during the closed period, be less productive than the closed area, and vessels might use more fuel and spend more time having to travel to open areas). The severity of the impacts of a closure would depend greatly on the length of the closure and where the most favored fishing grounds are during the closure. A study by NMFS (Chan, V. and D. Squires. 2016. Analyzing the economic impacts of the 2015 ELAPS closure. NMFS Internal Report) estimated that the overall losses to the combined sectors of the vessels, canneries and vessel support companies from the 2015 ELAPS closure ranged from $11 million and $110 million depending on the counterfactual period considered. These results suggest that there were impacts from the ELAPS closure on the American Samoa economy through impacts to the canneries and vessel support companies and a connection between U.S. purse seine vessels and the broader American Samoa economy. If there was a closure of the U.S. EEZ or high seas in the WCPO, it is likely there would be impacts to the American Samoa economy though the magnitude would depend on the length of the closure, and whether both or just one of the areas was closed to fishing.

If either the U.S. EEZ or high seas is closed, possible next-best opportunities for U.S. purse seine vessels fishing in the WCPO include fishing in the other of the two areas, fishing in foreign EEZs inside the Convention Area, fishing outside the Convention Area in EPO, and not fishing.

With respect to fishing in the U.S. EEZ or on the high seas: If the U.S. EEZ were closed, the high seas would be available to the fleet until its limit is reached. If the high seas were closed, the U.S. EEZ would be available until its limit is reached, but only for the vessels with fishery endorsements on their Certificates of Documentation (currently 8, including 6 vessels with SPTT licenses and two additional vessels without).

With respect to fishing in the Convention Area in foreign EEZs: As described above, under the SPTT the fleet might have substantial fishing days available in the PIP EEZs that dominate the WCPO, but it is not possible to predict how many fishing days will be available to the fleet as a whole or to individual fishing businesses.

With respect to fishing in the EPO: The fleet has generally increased its fishing operations in the EPO since 2014, and as of 2021, there were 13 purse seine vessels in the WCPO fleet that are also listed on the Inter-American Tropical Tuna Commission (IATTC) Vessel Register. In order to fish in the EPO, a vessel must be on the IATTC's Regional Vessel Register and categorized as active (50 CFR 300.22(b)), which involves fees of about $14.95 per cubic meter of well space per year ( e.g., a vessel with 1,200 m 3 of well space would be subject to annual fees of $17,940). (As an exception to this rule, an SPTT-licensed vessel is allowed to make one fishing trip in the EPO each year without being categorized as active on the IATTC Regional Vessel Register. The trip must not exceed 90 days in length, and there is an annual limit of 32 such trips for the entire SPTT-licensed fleet (50 CFR 300.22(b)(1)).) The number of U.S. purse seine vessels in the WCPO fleet that have opted to be categorized as active on the IATTC Regional Vessel Register has increased in the last few years from zero to 17, probably largely a result of constraints on fishing days in the WCPO and/or uncertainty in future access arrangements under the SPTT. This suggests an increasing attractiveness of fishing in the EPO, in spite of the costs associated with doing so. However, vessels probably will not have the opportunity to fish in the EPO year-round. To implement a recent decision of the IATTC, NMFS has published a final rule (87 FR 40731, July 8, 2022) that requires purse seine vessels to choose between two 72-day EPO fishing prohibition periods each year: July 29-October 8 or November 9-January 19. Thus, the opportunity to fish in the EPO might be constrained, depending on when the U.S. EEZ and/or high seas in the WCPFC Area is closed, and which EPO closure period a given vessel operator chooses.

Not fishing at all during a closure of the U.S. EEZ or high seas would mean a loss of any revenues from fishing. However, many of the vessels' variable operating costs would be avoided in that case, and it is possible that for some vessels a portion of the time might be used for productive activities like vessel and equipment maintenance.

The opportunity costs of engaging in next-best opportunities in the event of a closure are not known, so the potential impacts cannot be quantified. However, to give an indication of the magnitude of possible economic impacts to the fleet and an upper bound of those impacts, information on revenue per day is provided here.

The most recent 3 years for which catch estimates for the U.S. WCPO purse seine fleet are available are 2019-2021. Those estimates, adjusted to an indicative fleet size of 15 vessels, equate to annual average catches of skipjack tuna, yellowfin tuna, and bigeye tuna of 68,818 mt, 8,737 mt, and 6,087 mt, respectively, or 83,641 mt in total. Applying the 2020 Bangkok cannery price of $1,359 per mt for skipjack tuna and bigeye tuna and a 2019 Bangkok cannery price of $1,682 mt for yellowfin tuna (FFA 2020), the value of annual fleet-wide catches at 2019-2021 average levels would be about $116 million. It should be noted that cannery prices are fairly volatile; for example, cannery prices in 2017 were substantially higher than prices during the previous three years.

In addition to the effects described above, the proposed limits could affect the temporal distribution of fishing effort in the U.S. purse seine fishery. Since the limits would apply fleet-wide—that is, they would not be allocated to individual vessels—vessel operators might have an incentive to fish harder in the affected areas earlier in each calendar year than they otherwise would. To the extent such temporal shifts occur, they could affect the seasonal timing of fish catches and deliveries to canneries. The timing of cannery deliveries by the U.S. fleet alone (as it might be affected by a race to fish in the EEZ or high seas) is unlikely to have an appreciable impact on prices because many canneries in the Asia-Pacific region and elsewhere buy from the fleets of multiple nations. A race to fish could bring costs to affected entities if it causes vessel operators to forego vessel maintenance in favor of fishing or to fish in weather or ocean conditions that they otherwise would not. This could bring costs in terms of the health and safety of the crew as well as the economic performance of the vessel.

This element of the proposed rulewould not establish any new reporting or recordkeeping requirements. The new proposed compliance requirement would be for affected vessel owners and operators to cease retaining, landing, and transshipping bigeye tuna caught with longline gear in the Convention Area if and when the bigeye tuna catch limit of 3,358 mt (3,554 mt reduced by the 196 mt overage from 2021) is reached in 2022, for the remainder of the calendar year, subject to the exceptions specified at 50 CFR 300.224. These exceptions include the following: bigeye tuna landed in Guam, American Samoa, or CNMI; bigeye tuna caught by vessels with American Samoa Longline Limited Access Permits; and bigeye tuna caught by vessels in specified fishing agreements under 50 CFR 665.801.

Fulfillment of this requirement is not expected to require any professional skills that the vessel owners and operators do not already possess. The costs of complying with this requirement are described below to the extent possible.

Complying with this element of the proposed rule could cause foregone fishing opportunities and result in associated economic losses in the event that the bigeye tuna catch limit is reached in 2022 and the restrictions on retaining, landing, and transshipping bigeye tuna are imposed for a portion of that year. These costs cannot be projected quantitatively with any certainty. The proposed annual limit of 3,358 mt can be compared to catches in 2005-2008, before limits were in place. The average annual catch in that period was 4,709 mt. Based on that history, as well as fishing patterns in 2009-2021, when limits were in place, there appears to be a relatively high likelihood of the proposed limits being reached in 2022. In 2019, for example, which saw exceptionally high catches of bigeye tuna, the limit of 3,554 mt was estimated to have been reached by, and the fishery was closed on, July 27 (see temporary rule published July 24, 2019; 84 FR 35568). In 2020, the limit of 3,554 mt was estimated to have been reached by September 1, 2020, and in 2021, the limit of 3,554 mt was estimated to have been reached by September 6, 2021. Thus, if bigeye tuna catch patterns in 2022 are like those in 2005-2008, the limit would be reached in the fourth quarter of the year, and if they are like those in 2019, 2020, or 2021, the limit would be reached in the third quarter of the year.

If the bigeye tuna limit is reached before the end of 2022 and the Convention Area longline bigeye tuna fishery is consequently closed for the remainder of the calendar year, it can be expected that affected vessels would shift to the next most profitable fishing opportunity (which might be not fishing at all). Revenues from that next best alternative activity reflect the opportunity costs associated with longline fishing for bigeye tuna in the Convention Area. The economic cost of the proposed rule would not be the direct losses in revenues that would result from not being able to fish for bigeye tuna in the Convention Area, but rather the difference in benefits derived from that activity and those derived from the next best activity. The economic cost of the proposed rule on affected entities is examined here by first estimating the direct losses in revenues that would result from not being able to fish for bigeye tuna in the Convention Area as a result of the catch limit being reached. Those losses represent the upper bound of the economic cost of the proposed rule on affected entities. Potential next-best alternative activities that affected entities could undertake are then identified in order to provide a (mostly qualitative) description of the degree to which actual costs would be lower than that upper bound.

Upper bounds on potential economic costs can be estimated by examining the projected value of longline landings from the Convention Area that would not be made as a result of reaching the limit. For this purpose, it is assumed that, absent this proposed rule, bigeye tuna catches in the Convention Area in 2022 would be 3,554 mt, the bigeye tuna limit currently in place. Under this scenario, imposition of a limit of 3,358 mt would result in 6 percent less bigeye tuna being caught in 2022 than under no action. In the deep-set fishery, catches of marketable species other than bigeye tuna would likely be affected in a similar way if vessels do not shift to alternative activities. Assuming for the moment that ex-vessel prices would not be affected by a fishery closure, under the proposed rule, revenues in 2022 to entities that participate exclusively in the deep-set fishery would be approximately 6 percent less than under no action. Average annual ex-vessel revenues (from all species) per mt of bigeye tuna caught during 2018-2020 were about $13,740/mt (in 2020 dollars, derived from the latest available annual report on the pelagic fisheries of the western Pacific Region (Western Pacific Regional Fishery Management Council, 2021, Annual Stock Assessment and Fishery Evaluation Report: 2020. Honolulu, Western Pacific Fishery Management Council; https://www.wpcouncildata.org/pelagicsafereport/ ). Applying the average ex-vessel revenues (from all species) of $13,740 per mt of bigeye tuna caught, the estimated reductions in ex-vessel revenue from a 196 mt decrease in the bigeye catch limit would be approximately $14,000 for 2022 or on average a reduction of $95 per vessel.

In the shallow-set fishery, affected entities would bear limited costs in the event of the limit being reached (but most affected entities also participate in the deep-set fishery and might bear costs in that fishery, as described below). The cost would be about equal to the revenues lost from not being able to retain or land bigeye tuna captured while shallow-setting in the Convention Area, or the cost of shifting to shallow-setting in the EPO, which is to the east of 150 degrees W. longitude, whichever is less. In the fourth calendar quarters of 2019-2021, almost all shallow-setting effort took place in the EPO, and 91 percent of bigeye tuna catches were made there, so the cost of a bigeye tuna fishery closure to shallow-setting vessels would appear to be very limited. During 2019-2021, the shallow-set fishery caught an average of 15 mt of bigeye tuna per year from the Convention Area. If the proposed bigeye tuna catch limit is reached even as early as July 31 in 2022, the Convention Area shallow-set fishery would have caught at that point, based on 2019-2022 data, on average, 94 percent of its average annual bigeye tuna catches. Imposition of the landings restriction at that point in 2022 would result in the loss of revenues from approximately 0.9 mt (6 percent of 15 mt) of bigeye tuna, which, based on recent ex-vessel prices, would be worth no more than $5,700. Thus, expecting about 13 vessels to engage in the shallow-set fishery (the annual average in 2019-2021), the average of those potentially lost annual revenues would be no more than $436 per vessel. The remainder of this analysis focuses on the potential costs of compliance in the deep-set fishery.

It should be noted that the impacts on affected entities' profits would be less than impacts on revenues when considering the costs of operating vessels, because costs would be lower if a vessel ceases fishing after the catch limit is reached. Variable costs can be expected to be affected roughly in proportion to revenues, as both variable costs and revenues would stop accruing once a vessel stops fishing. But affected entities' costs also include fixed costs, which are borne regardless of whether a vessel is used to fish— e.g., if it is tied up at the dock during a fishery closure. Thus, profits would likely be adversely impacted proportionately more than revenues.

As stated previously, actual compliance costs for a given entity might be less than the upper bounds described above, because ceasing fishing would not necessarily be the most profitable alternative opportunity when the catch limit is reached. Two alternative opportunities that are expected to be attractive to affected entities include: (1) deep-set longline fishing for bigeye tuna in the Convention Area in a manner such that the vessel is considered part of the longline fishery of American Samoa, Guam, or the CNMI; and (2) deep-set longline fishing for bigeye tuna and other species in the EPO. These two opportunities are discussed in detail below. Four additional opportunities are: (3) shallow-set longline fishing for swordfish (for deep-setting vessels that would not otherwise do so), (4) deep-set longline fishing in the Convention Area for species other than bigeye tuna, (5) working in cooperation with vessels operating as part of the longline fisheries of the Participating Territories—specifically, receiving transshipments at sea from them and delivering the fish to the Hawaii market, and (6) vessel repair and maintenance. A study by NMFS of the effects of the WCPO bigeye tuna longline fishery closure in 2010 (Richmond, L., D. Kotowicz, J. Hospital and S. Allen, 2015, Monitoring socioeconomic impacts of Hawai`i's 2010 bigeye tuna closure: Complexities of local management in a global fishery, Ocean & Coastal Management 106:87-96) did not identify the occurrence of any alternative activities that vessels engaged in during the closure, other than deep-setting for bigeye tuna in the EPO, vessel maintenance and repairs, and granting lengthy vacations to employees. Based on those findings, NMFS expects that alternative opportunities (3), (4), and (5) are probably unattractive relative to the first two alternatives, and are not discussed here in any further detail. NMFS recognizes that vessel maintenance and repairs and granting lengthy vacations to employees are two alternative activities that might be taken advantage of if the fishery is closed, but no further analysis of their mitigating effects is provided here, because costs would likely be similar or greater of those anticipated if the vessel chose to cease fishing.

Before examining in detail the two potential alternative fishing opportunities that would appear to be the most attractive to affected entities, it is important to note that under the proposed rule, once the limit is reached and the WCPO bigeye tuna fishery is closed, fishing with deep-set longline gear both inside and outside the Convention Area during the same trip would be prohibited (except in the case of a fishing trip that is in progress when the limit is reached and the restrictions go into effect). For example, after the restrictions go into effect, during a given fishing trip, a vessel could be used for longline fishing for bigeye tuna in the EPO or for longline fishing for species other than bigeye tuna in the Convention Area, but not for both. This reduced operational flexibility would bring costs, since it would constrain the potential profits from alternative opportunities. Those costs cannot be quantified.

A vessel could take advantage of the first alternative opportunity (deep-setting for bigeye tuna in a manner such that the vessel is considered part of the longline fishery of one of the three U.S. Participating Territories), by three possible methods: a) landing the bigeye tuna in one of the three Participating Territories, b) holding an American Samoa Longline Limited Access Permit, or c) being considered part of a Participating Territory's longline fishery, by agreement with one or more of the three Participating Territories under the regulations implementing Amendment 7 to the Pelagics FEP (50 CFR 665.819). In the first two circumstances, the vessel would be considered part of the longline fishery of the Participating Territory only if the bigeye tuna were not caught in the portion of the U.S. EEZ around the Hawaiian Islands and were landed by a U.S. vessel operating in compliance with a permit issued under the regulations implementing the Pelagics FEP or the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species.

With respect to the first method of engaging in alternative opportunity 1 (1.a.) (landing the bigeye tuna in one of the Participating Territories), there are three potentially important constraints. First, whether the fish are landed by the vessel that caught the fish or by a vessel to which the fish were transshipped, the costs of a vessel transiting from the traditional fishing grounds in the vicinity of the Hawaiian Archipelago to one of the Participating Territories would be substantial. Second, none of these three locales has large local consumer markets to absorb substantial additional landings of fresh sashimi-grade bigeye tuna. Third, transporting the bigeye tuna from these locales to larger markets, such as markets in Hawaii, the U.S. west coast, or Japan, would bring substantial additional costs and risks. These cost constraints suggest that this alternative opportunity has limited potential to mitigate the economic impacts of the proposed rule on affected small entities.

The second method of engaging in the first alternative opportunity (1.b.) (having an American Samoa Longline Limited Access Permit), would be available only to the subset of the Hawaii longline fleet that has both Hawaii and American Samoa longline permits (dual permit vessels). Vessels that do not have both permits could obtain them if they meet the eligibility requirements and pay the required costs. For example, the number of dual permit vessels increased from 12 in 2009, when the first WCPO bigeye tuna catch limit was established, to 27 from 2018-2020, and was 25 in 2021. The previously cited NMFS study of the 2010 fishery closure (Richmond et al. 2015) found that bigeye tuna landings of dual permit vessels increased substantially after the start of the closure on November 22, 2010, indicating that this was an attractive opportunity for dual permit vessels, and suggesting that those entities might have benefitted from the catch limit and the closure.

The third method of engaging in the first alternative opportunity (1.c.) (entering into an Amendment 7 agreement), was also available in 2011-2021 (in 2011-2013, under section 113(a) of Pub. L. 112-55, 125 Stat. 552 et seq., the Consolidated and Further Continuing Appropriations Act, 2012, continued by Pub. L. 113-6, 125 Stat. 603, section 110, the Department of Commerce Appropriations Act, 2013; hereafter, “section 113(a)”). As a result of agreements that were in place in 2011-2014, the WCPO bigeye tuna fishery was not closed in any of those years. In 2015-2019 the fishery was closed but then reopened when agreements went into effect. Agreements were also in place in 2020 and 2021. The fishery did not close in 2020, but the bigeye catch limit was exceeded in 2021. Participation in an Amendment 7 agreement would likely not come without costs to fishing businesses. As an indication of the possible cost, the terms of the agreement between American Samoa and the members of the Hawaii Longline Association (HLA) in effect in 2011 and 2012 included payments totaling $250,000 from the HLA to the Western Pacific Sustainable Fisheries Fund, equal to $2,000 per vessel. It is not known how the total cost was allocated among the members of the HLA, so it is possible that the owners of particular vessels paid substantially more than or less than $2,000.

The second alternative opportunity (2) (deep-set fishing for bigeye tuna in the EPO), would be an option for affected entities only if it is allowed under regulations implementing the decisions of the IATTC. NMFS has issued a final rule to implement the IATTC's most recent resolution on the management of tropical tuna stocks (87 FR 40731, July 8, 2022). The proposed rule would establish an annual limit of 750 mt on the catch of bigeye tuna in the EPO by vessels at least 24m in length per calendar year. Annual longline bigeye tuna catch limits have been in place for the EPO in most years since 2004. Since 2009, when the limit was 500 mt, it was reached in 2013 (November 11), 2014 (October 31), and 2015 (August 12). In 2016 NMFS forecasted that the limit would be reached July 25 and subsequently closed the fishery, but later determined that the catch limit had not been reached and re-opened the fishery on October 4, 2016 (81 FR 69717). In 2017, NMFS forecasted that the limit would be reached by September 8 and subsequently closed the fishery (82 FR 41562). The limit was not reached in 2018-2021.

The highly seasonal nature of bigeye tuna catches in the EPO and the relatively high inter-annual variation in catches prevents NMFS from making a useful prediction of whether and when the EPO limit in 2022 is likely to be reached. If it is reached, this alternative opportunity would not be available for large longline vessels, which constitute about a quarter of the fleet.

Historical fishing patterns can provide an indication of the likelihood of affected entities making use of the opportunity of deep-setting in the EPO in the event of a closure in the WCPO. The proportion of the U.S. fishery's annual bigeye tuna catches that were captured in the EPO from 2005 through 2008 ranged from 2 percent to 22 percent, and averaged 11 percent. In 2005-2007, that proportion ranged from 2 percent to 11 percent, and may have been constrained by the IATTC-adopted bigeye tuna catch limits established by NMFS (no limit was in place for 2008). Prior to 2009, most of the U.S. annual bigeye tuna catch by longline vessels in the EPO typically was made in the second and third quarters of the year; in 2005-2008 the percentages caught in the first, second, third, and fourth quarters were 14, 33, 50, and 3 percent, respectively. These data demonstrate two historical patterns—that relatively little of the bigeye tuna catch in the longline fishery was typically taken in the EPO (11 percent in 2005-2008, on average), and that most EPO bigeye tuna catches were made in the second and third quarters, with relatively few catches in the fourth quarter when the proposed catch limit would most likely be reached. These two patterns suggest that there could be substantial costs for at least some affected entities that shift to deep-set fishing in the EPO in the event of a closure in the WCPO. On the other hand, fishing patterns since 2008 suggest that a substantial shift in deep-set fishing effort to the EPO could occur. In 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020 and 2021 the proportions of the fishery's annual bigeye tuna catches that were captured in the EPO were about 16, 27, 22, 18, 35, 35, 46, 36, 48, 42, 33, 29 and 28 percent, respectively, and most bigeye tuna catches in the EPO were made in the latter half of the calendar years.

The NMFS study of the 2010 closure (Richmond et al. 2015) found that some businesses—particularly those with smaller vessels—were less inclined than others to fish in the EPO during the closure because of the relatively long distances that would need to be travelled in the relatively rough winter ocean conditions. The study identified a number of factors that likely made fishing in the EPO less lucrative than fishing in the WCPO during that part of the year, including fuel costs and the need to limit trip length in order to maintain fish quality and because of limited fuel storage capacity.

In addition to affecting the volume of landings of bigeye tuna and other species, the proposed catch limits could affect fish prices, particularly during a fishery closure. Both increases and decreases appear possible. After a limit is reached and landings from the WCPO are prohibited, ex-vessel prices of bigeye tuna ( e.g., that are caught in the EPO or by vessels in the longline fisheries of the three U.S. Participating Territories), as well as of other species landed by the fleet, could increase as a result of the constricted supply. This would mitigate economic losses for vessels that are able to continue fishing and landing bigeye tuna during the closure. For example, the NMFS study of the 2010 closure (Richmond et al. 2015) found that ex-vessel prices during the closure in December were 50 percent greater than the average during the previous five Decembers. (It is emphasized that because it was an observational study, neither this nor other observations of what occurred during the closure can be affirmatively linked as effects of the fishery closure.)

Conversely, a WCPO bigeye tuna fishery closure could cause a decrease in ex-vessel prices of bigeye tuna and other products landed by affected entities if the interruption in the local supply prompts the Hawaii market to shift to alternative ( e.g., imported) sources of bigeye tuna. Such a shift could be temporary—that is, limited to 2022—or it could lead to a more permanent change in the market ( e.g., as a result of wholesale and retail buyers wanting to mitigate the uncertainty in the continuity of supply from the Hawaii longline fisheries). In the latter case, if locally caught bigeye tuna fetches lower prices because of stiffer competition with imported bigeye tuna, then ex-vessel prices of local product could be depressed indefinitely. The NMFS study of the 2010 closure (Richmond et al. 2015) found that a common concern in the Hawaii fishing community prior to the closure in November 2010 was retailers having to rely more heavily on imported tuna, causing imports to gain a greater market share in local markets. The study found this not to have been borne out, at least not in 2010, when the evidence gathered in the study suggested that few buyers adapted to the closure by increasing their reliance on imports, and no reports or indications were found of a dramatic increase in the use of imported bigeye tuna during the closure. The study concluded, however, that the 2010 closure caused buyers to give increased consideration to imports as part of their business model, and it was predicted that tuna imports could increase during any future closure. To the extent that ex-vessel prices would be reduced by this action, revenues earned by affected entities would be affected accordingly, and these impacts could occur both before and after the limit is reached, and as described above, possibly after 2022.

The potential economic effects identified above would vary among individual business entities, but it is not possible to predict the range of variation. Furthermore, the impacts on a particular entity would depend on both that entity's response to the proposed rule and the behavior of other vessels in the fleet, both before and after the catch limit is reached. For example, the greater the number of vessels that take advantage—before the limit is reached—of the first alternative opportunity (1), fishing as part of one of the Participating Territory's fisheries, the lower the likelihood that the limit would be reached. The fleet's behavior in 2011 and 2012 is illustrative. In both those years, most vessels in the Hawaii fleet were included in a section 113(a) arrangement with the government of American Samoa, and as a consequence, the U.S. longline catch limit was not reached in either year. Thus, none of the vessels in the fleet, including those not included in the section 113(a) arrangements, were prohibited from fishing for bigeye tuna in the Convention Area at any time during those two years. The fleet's experience in 2010 (before opportunities under section 113(a) or Amendment 7 to the Pelagics FEP were available) provides another example of how economic impacts could be distributed among different entities. In 2010 the limit was reached and the WCPO bigeye tuna fishery was closed on November 22. As described above, dual permit vessels were able to continue fishing outside the U.S. EEZ around the Hawaiian Archipelago and benefit from the relatively high ex-vessel prices that bigeye tuna fetched during the closure.

In summary, based on potential reductions in ex-vessel revenues, NMFS has estimated that the upper bound of potential economic impacts of the proposed rule on affected longline fishing entities could be roughly $531 per vessel per year, on average. The actual impacts to most entities are likely to be substantially less than those upper bounds, and for some entities the impacts could be neutral or positive ( e.g., if one or more Amendment 7 agreements are in place in 2022 and the terms of the agreements are such that the U.S. longline fleet is effectively unconstrained by the catch limits).

This element of the proposed rule would require submission of the existing “Daily purse seine fishing effort reports.” Fulfillment of this element's proposed requirements is not expected to necessitate any professional skills that the vessel owners and operators do not already possess. NMFS has intermittently directed vessel owners and operators to provide this information since September 6, 2018. This modification is not expected to change costs of compliance that have been previously analyzed (see 83 FR 33851; July 18, 2018). The estimated cost and burden of this reporting requirement is discussed further in the Paperwork Reduction Act (PRA) section below.

This element of the proposed rule would not establish any new reporting or recordkeeping requirements nor is it expected to change the costs of compliance.

This element of the proposed rule would not establish any new reporting or recordkeeping requirements nor is it expected to change the costs of compliance.

There would be no disproportionate economic impacts between small and large entities operating vessels resulting from this rule. Furthermore, there would be no disproportionate economic impacts based on vessel size, gear or homeport.

NMFS has not identified any Federal regulations that duplicate, overlap with, or conflict with the proposed regulations.

NMFS has sought to identify alternatives that would minimize the proposed rule's economic impacts on small entities (“significant alternatives”). Taking no action, where no action is defined as no purse seine effort limits or bigeye tuna catch limits in place could result in lesser adverse economic impacts than the proposed action for affected entities, but NMFS does not prefer the no-action alternative, because it would be inconsistent with the United States' obligations under the Convention. Taking no action, where no action is defined as leaving the combined purse seine fishing effort limits in place and not adjusting the 2022 longline bigeye tuna catch limit to account for the overage of the limit in 2021, could also result in lesser adverse economic impacts than the proposed action for affected entities, but NMFS believes the modifications are necessary to better fulfill the Unites States' obligations under the Convention. Alternatives to the proposed rule are discussed below.

NMFS has established combined limits for the ELAPS in previous years to provide increased operational flexibility to the U.S. purse seine fleet fishing in the WCPO. Although NMFS has proposed to establish separate U.S. EEZ and high seas limits, as discussed throughout this document, NMFS has analyzed the environmental and economic impacts of implementation of the combined limit in the supporting documents issued in conjunction with this proposed rule. NMFS invites the public to submit comments on the economic impact of its proposal to separate the limits.

NMFS has not identified any significant alternatives for this element of the proposed rule, other than the two no-action alternative described above (either no limit in place or the existing limit of 3,554 mt). NMFS has considered the economic impacts of the two no-action alternatives in the RIR being issued with this rule. As stated above, the no-action alternatives could result in lesser adverse economic impacts than the proposed action for affected entities, because there would either be no limit in place or a greater limit in place. NMFS believes implementation of the adjusted 2022 longline bigeye tuna catch limit is necessary to better fulfill the United States' obligations under the Convention.

NMFS previously conducted an estimate of the cost and burden of submitting daily purse seine effort reports in the Convention Area under Control Number 0648-0649, Transshipment Requirements under the WCPFC. NMFS estimated that the cost and burden of submitting a daily report would include 10 minutes maximum to complete the form and $4.07 per submission. In this proposed rule, NMFS would codify the requirement to submit daily purse seine effort reports, instead of only requiring them “as directed.” Because NMFS has been directing vessel owners and operators to submit these daily reports, this proposed rule would not introduce any new costs or burdens beyond what has already been evaluated under Control Number 0648-0649.

For the reasons set out in the preamble, 50 CFR part 300 is amended as follows: