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SECY-24-0069: Enclosure 4 - Final RA Document (Draft) Part 71
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Harmonization of Transportation Safety Requirements with International Atomic Energy Agency Final RuleRegulatory Analysis U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards Division of Rulemaking, Environmental, and Financial Support

[ENTER DATE WHEN READY TO BE ISSUED]

ii Abstract In consultation with the U.S. Department of Transportation (DOT), the U.S. Nuclear Regulatory Commission (NRC) is amending its regulations for packaging and transporting radioactive material. Historically, the NRC has been consistent in harmonizing its transportation safety regulations with International Atomic Energy Agency (IAEA) standards. These changes are necessary to maintain a consistent regulatory framework with the DOT for the domestic packaging and transportation of radioactive material and to ensure general accord with these standards. Concurrently, the NRC is issuing Revision 3 to Regulatory Guide (RG) 7.9, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material. The guidance identifies the information to be provided for package approval and establishes a uniform format for presenting that information.

This document presents a regulatory analysis of the final rule, Harmonization of Transportation Safety Requirements with International Atomic Energy Agency, and RG 7.9. The rule will result in a net incremental cost of ($2,457,000). The cost estimate represents the following estimated costs and savings for licensees, certificate of compliance (CoC) holders, Agreement States, and the NRC:

Licensees are estimated to save $4,187,000.

CoC holders are expected to incur a cost of ($3,542,000).

The NRC is expected to incur a cost of ($724,000).

Agreement States are expected to incur a net cost of ($2,378,000) to implement the rule and revise procedures. This estimate includes the cost for Agreement State implementation of the rule ($2,242,000). The rulemaking action will also result in a marginal operational cost of ($135,000) to the Agreement States.

The rule was not shown quantitatively to be cost justified in that the total net incremental quantified costs are estimated to exceed the incremental quantified averted costs (i.e., savings) by ($2,457,000). However, the rulemaking represents the best option that can address all the issues and could result in net savings of $645,000 in net averted costs to industry. In addition to the quantified costs and benefits, the final rule is expected to have important benefits that cannot be reliably quantified. These unquantified benefits include labor savings and damages avoided due to (1) harmonization of the NRC regulations in Title 10 of the Code of Federal Regulations Part 71, Packaging and Transportation of Radioactive Material, with the IAEAs safety standards, thereby reducing the regulatory burden on licensees by eliminating conflicting requirements, (2) assurance that the NRCs regulations continue to be consistent with the DOT regulations for domestic transportation of radioactive materials, and (3) consistency with the agencys response to previous revisions and updates of IAEA standards, without any broad programmatic requirements or significant negative impacts on the NRCs licensees or CoC holders. If the value of these unquantified benefits of the rule are considered, the rule is cost justified.

To improve the credibility of the NRCs cost estimates for this regulatory action, the agency conducted an uncertainty analysis to consider the effects of input uncertainty on the cost

iii estimate and a sensitivity analysis to identify the variables that most affect the cost estimate (i.e., the cost drivers).

iv Table of Contents Section Page Abstract......................................................................................................................................... ii Table of Contents......................................................................................................................... iv List of Figures............................................................................................................................... v List of Tables................................................................................................................................. v Abbreviations and Acronyms....................................................................................................... vii Executive Summary.................................................................................................................... viii 1

Introduction............................................................................................................................ 1 2

Statement of the Problem and Objective............................................................................... 1 2.1 Background.................................................................................................................. 1 2.2 Statement of the Problem............................................................................................ 2 2.3 Objectives.................................................................................................................... 3 3

Discussion of Alternatives...................................................................................................... 3 3.1 Action the NRC Is Taking............................................................................................. 3 3.2 Applicability of the Action............................................................................................. 3 3.3 Changes to NRC Transportation Regulations.............................................................. 4 3.4 Impacted Regulatory Guidance Documents............................................................... 19 4

Estimates of Costs and Savings.......................................................................................... 19 4.1 Basis for Cost and Savings Estimates....................................................................... 19 4.2 Evaluation of Alternative 2 (NRC Transportation Regulations).................................. 20 5

Uncertainty Analysis............................................................................................................ 49 5.1 Uncertainty Analysis Assumptions............................................................................. 49 5.2 Uncertainty Analysis Results...................................................................................... 50 6

Other Impacts and Regulatory Considerations.................................................................... 52 6.1 Impacts on Licensees and Certificate-Holders........................................................... 52 6.2 Impacts on Agreement States.................................................................................... 52 6.3 Compliance with the National Environmental Policy Act............................................ 53 7

Cost Analysis Summary and Conclusions........................................................................... 53 8

Implementation.................................................................................................................... 56 9

References.......................................................................................................................... 56 Appendix A Cost Uncertainty Analysis.................................................................................... 1

v List of Figures Figure Page Figure 1 Tornado diagram of rulemaking7 percent NPV.................................................. 51 Figure A-1 Issue 1Revision of fissile exemptions7 percent NPV............................... A-2 Figure A-2 Issue 4Revision of insolation requirements for package evaluations 7 percent NPV..................................................................................................... A-2 Figure A-3 Issue 6Deletion of the low specific activity-III leaching test 7 percent NPV..................................................................................................... A-3 Figure A-4 Issue 7Inclusion of new definition for surface contaminated object (SCO)-III7 percent NPV................................................................................... A-3 Figure A-5 Issue 8Revision of uranium hexafluoride (UF6) package requirements (UF6 cylinder plugs)7 percent NPV.................................................................... 4 Figure A-6 Issue 9Inclusion of evaluation of aging mechanisms and a maintenance program7 percent NPV....................................................................................... 4 Figure A-7 Issue 10Revision of transitional arrangements7 percent NPV.................... 5 Figure A-8 Issue 11Inclusion of head space for liquid expansion7 percent NPV......... 5 Figure A-9 Issue 12Revision of quality assurance program biennial reporting requirements7 percent NPV............................................................................... 6 Figure A-10 Issue 13Deletion of type A package limitations in fissile material general licenses7 percent NPV....................................................................................... 6 Figure A-11 Issue 14Deletion of uranium-233 (233U) restriction in fissile general license7 percent NPV......................................................................................... 7 Figure A-12 Issue 15.1Deletion of duplicative reporting requirements in 10 CFR 71.957 percent NPV............................................................................................ 7 Figure A-13 Net benefit7 percent NPV.................................................................................. 8 Figure A-14 Tornado diagram of rulemaking7 percent NPV.............................................. 8 List of Tables Table Page Table ES-1 Net Benefits (Costs) by Issue............................................................................... ix Table ES-2 Net Benefits (Costs) by Affected Entity................................................................ x Table 1 Estimated Averted Cost of Making Shipments with New Fissile Exemption........ 22 Table 2 Averted Cost to Licensees Using New 140 Gram Fissile Exemption.................... 23 Table 3 Averted NRC Review Cost for 140 Gram Fissile Exemption.................................. 23 Table 4 Licensee Shipping Benefit Using the 140 Gram Fissile Exemption...................... 24

vi Table 5 Cost for Certificate Holders to Prepare an Application Evaluating New Insolation Value...................................................................................................................... 25 Table 6 NRC Cost to Review Applications for Revised CoCs.............................................. 26 Table 7 Licensee Accrued Costs for New CoCs................................................................... 27 Table 8 NRC Incremental Costs to Review New CoCs......................................................... 27 Table 9 Certificate Holder Cost to Evaluate Insolation as an Initial Condition.................. 28 Table 10 NRC Cost to Review Applications for Revised CoCs............................................ 29 Table 11 Licensee Costs to Submit Certificate for New CoC............................................... 29 Table 12 NRC Incremental Costs to Review New CoCs....................................................... 30 Table 13 Averted Cost for Deletion of Leaching Test........................................................... 31 Table 14 Averted Cost for Licensees Using SCO-III Package............................................. 32 Table 15 Averted Cost for NRC Review for Licensees Using SCO-III................................. 33 Table 16 Cost to Prepare Application for Revised UF6 CoC................................................ 34 Table 17 NRC Cost to Review Application for Certificate Revision.................................... 35 Table 18 Certificate Holder Cost to Revise Certificates........................................................ 36 Table 19 Licensee Cost to Maintain Casks............................................................................. 36 Table 21 Certificate Holder Cost to Revise Certificates....................................................... 38 Table 22 NRC Review Time for Revised Certificates Cost................................................... 38 Table 23 Certificate Holder Cost to Prepare an Application for a Replacement Package 39 Table 24 NRC Review Cost for Reviewing an Application for a Replacement Package... 40 Table 25 Licensee Cost to Prepare and Evaluate Liquid Expansion.................................. 40 Table 26 NRC Cost to Evaluate Application for Liquid Expansion..................................... 41 Table 27 Licensee Cost to Evaluate Program Change for Biennial Reports...................... 42 Table 28 Licensee Cost to Submit Biennial Report.............................................................. 42 Table 29 NRC Cost to Review Biennial Report..................................................................... 43 Table 31 Averted NRC Cost to Review Application for Approval for Shipment in Type BF Package................................................................................................................. 45 Table 32 Averted Licensee Cost to Make Shipment Using New Type B Package Limits.. 46 Table 33 Licensee Averted Cost for Transporting Using General License in 10 CFR 71.22 47 Table 34 Agreement States Costs to Review Reports.......................................................... 48 Table 35 Alternative 2 Summary Table by Cost Type and Impacted Organization............ 54 Table A-1 Uncertainty Analysis Input Variables................................................................. A-9 Table A-2 Descriptive Statistics on the Uncertainty Results (7 Percent NPV)............... A-16

vii Abbreviations and Acronyms 233U uranium-233 235U uranium-235

°C degrees Celsius CFR Code of Federal Regulations CoC certificate of compliance CSI criticality safety index DOE U.S. Department of Energy DOT U.S. Department of Transportation EA environmental assessment FR Federal Register g cal/cm2 gram-calories per square centimeter h

hour IAEA International Atomic Energy Agency LSA low specific activity MOU memorandum of understanding mrem millirem mSv millisievert NRC U.S. Nuclear Regulatory Commission NPV net present value NUREG Nuclear Regulatory Publication PERT program evaluation and review technique QAP quality assurance program SCO surface contaminated object SRM staff requirements memorandum SSR specific safety requirements Sv sievert U

uranium UF6 uranium hexafluoride

viii Executive Summary In consultation with the U.S. Department of Transportation (DOT), the U.S. Nuclear Regulatory Commission (NRC) published a final rule on June 12, 2015, that amended the NRCs regulations for packaging and transporting radioactive material (80 FR 33988, June 12, 2015) [1]. These amendments made conforming changes to the NRCs regulations based on the standards of the International Atomic Energy Agency (IAEA). That final rule, in combination with a DOT final rule (79 FR 40590, July 11, 2014) [3] amending Title 49 of the Code of Federal Regulations (CFR), brought U.S. regulations into general accord with the 2009 edition of the IAEAs Regulations for the Safe Transport of Radioactive Material (TS-R-1, 2009 Edition) [4]. The IAEA has since updated its standards for the transport of radioactive material in Specific Safety Requirements No. 6 (SSR-6) (2012 and 2018 Editions, issued in 2012 and 2018, respectively) [5,7]. In that final rule, the Commission stated that the NRC will consider any necessary changes related to SSR-6 in a future rulemaking after consulting with the DOT.

In SECY-16-0093, Rulemaking Plan for Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements, dated July 28, 2016 [8], the NRC staff requested Commission approval to initiate a rulemaking related to harmonizing 10 CFR Part 71, Packaging and Transportation of Radioactive Material, with the updated IAEA standards in SSR-6, 2012 Edition, along with the then-anticipated SSR-6, 2018 Edition, and DOT regulations. The Commission approved the NRC staff recommendation in the associated staff requirements memorandum (SRM),

SRM-SECY-16-0093, dated August 19, 2016 [9]. This rulemaking harmonizing NRC regulations with SSR-6, 2018 Edition, includes changes made in SSR-6, 2012 Edition, that have been carried forward.

The DOT and the NRC coregulate transportation of radioactive materials in the United States.

The roles of the DOT and the NRC in the coregulation of the transportation of radioactive materials are documented in a memorandum of understanding dated July 2, 1979 (44 FR 38690) [10]. The NRC and the DOT have historically coordinated to harmonize their respective regulations to the IAEA revisions through the rulemaking process.

The NRC reviewed the updated IAEA standards [5,7] and identified 15 regulatory issues to be analyzed during the rulemaking development process. Issues 1-14 were previously documented in an issues paper [11]. In addition to the harmonization issues, NRC staff identified administrative and editorial changes that are needed to clarify certain regulations. The NRC staff also identified additional items to consider in the rulemaking that were not covered in the issues paper (reporting requirements; definition of low specific activity (LSA); advance notification of shipments of irradiated reactor fuel and nuclear waste; Tables A-1, A1 and A2 Values For Radionuclides, and A-2, Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides, in Appendix A, Determination of A1 and A2, to 10 CFR Part 71; and the changes to Agreement State compatibility categories); these items were grouped under a new issue that was designated as Issue 15.

The NRC issued a notice of the issues paper, public meeting, and request for comment in the Federal Register on November 21, 2016 [12], and held a public meeting on December 5-6, 2016, to discuss the issues paper. The NRC subsequently issued a summary of the public meeting [13]. After the public meeting, the NRC received 49 comment letters on the issues paper, identified comments that are pertinent to the rulemaking action, and considered these comments in the development of the regulatory basis [22].

ix In this regulatory analysis, the NRC considers and evaluates two alternative actions to align the NRCs regulations with IAEA standards and DOT regulations: a no-action option maintaining the status quo (Alternative 1) and an action to initiate a rulemaking to revise 10 CFR Part 71 (Alternative 2).

The alternatives were analyzed 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 2) represents the best approach to accomplish the goal of harmonization with SSR-6, and it is the agencys recommended action. Table ES-1 lists the 15 regulatory issues the NRC identified and analyzed, including the recommended action and net present value (NPV) estimates of cost and potential benefits by issue. All costs are in 2020 dollars and are calculated using a 7 percent discount rate.

Table ES-1 Net Benefits (Costs) by Issue*

Issue No.

Description Net Benefits (Costs)

(2020 Dollars at 7% NPV)a 1

Revision of Fissile Exemptions

$3,002,000 2

Revision of Reduced External Pressure Test for Normal Conditions of Transportb

$0 3

Type C Package Standardsb Not Analyzed 4

Revision of Insolation Requirements for Package Evaluations

($1,161,000) 5 Inclusion of Definition for Radiation Levelc

$0 6

Deletion of the Low Specific Activity-III Leaching Test

$60,000 7

Inclusion of New Definition for Surface Contaminated Object

$959,000 8

Revision of Uranium Hexafluoride Package Requirements (UF6 Cylinder Plugs)

($67,000) 9 Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program

($2,545,000) 10 Revision of Transitional Arrangements

($1,615,000) 11 Inclusion of Head Space for Liquid Expansion

($6,000) 12 Revision of Quality Assurance Program Biennial Reporting Requirements

($25,000) 13 Deletion of Type A Package Limitations in Fissile Material General Licenses

$19,000 14 Deletion of 233U Restriction in Fissile General License

$1,300,000 15 Other Recommended Changes to 10 CFR 71.95

($135,000)

Operation Costs (By Issue) Total

($214,000)

Agreement State Implementation Costs

($2,242,000)

Total Benefits (Costs)

($2,457,000)

These totals include industry, Agreement States, and the NRC.

a (1) The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

(2) The values are rounded to the nearest thousand dollars.

(3) Benefits and averted costs are positive; costs are (negative).

b The staff did not analyze the costs for Issue 3 because the agency is not adopting Type C standards in NRC regulations for domestic transport. The NRC analyzed the costs for proposed alternatives in Issue 2, but the alternative adopted in the final rule imposed no costs or benefits.

c The costs for Issue 5 are solely for performing the rulemaking and are calculated in the NRC implementation costs.

x This NRC rulemaking will address and resolve all issues except for Issues 2 and 3 (no-action to harmonize with SSR-6):

IAEA harmonization issues (Issues 1, 4-11, and 15 (in part)): Staff assessments of these issues identified revisions to harmonize the existing regulations with IAEA standards.

DOT compatibility issues (Issues 6, 7, 10, 11, and 15 (in part)): Staff assessments of these issues identified revisions to ensure compatibility between revisions to the NRC regulations in 10 CFR Part 71 and amendments to the DOT regulations.

Administrative, editorial, or clarification issues (Issues 12-15 (in part)). Staff assessments of these issues identified changes to clarify the regulations and improve 10 CFR Part 71 implementation.

The total cost in table ES-2 includes estimates of the NRC operational costs, where applicable, during the first 19 years after the effective date of the rule (2025 through 2035, inclusive). The NRC chose this timeframe because, on average, agency rulemakings to harmonize 10 CFR Part 71 with IAEA standards have followed an 11-year cycle. The total cost is the NPV of costs and benefits in 2020 dollars. Averted costs are costs of activities and actions performed under the existing regulations that will no longer be required when revisions to the regulations are implemented, and they are assigned positive values. Costs that are new, or additional actions associated with the rule, are assigned negative values and displayed in parentheses.

The rule has the following estimated costs, including its associated guidance development:

The NRC will incur a cost of ($724,000) for operations.

The Agreement States will incur a total net cost of ($2,378,000) to implement the rule, adopt equivalent requirements, and revise procedures. This estimate includes the cost of Agreement State implementation of the rule ($2,242,000) and a small operational cost of

($135,000).

The rule will result in a net benefit to industry of $645,000. This comprises a savings of

$4,187,000 to fissile material licensees and nuclear power plant licensees that ship Low Specific Activity Category III (LSA-III) material. However, the NRC expects that certificate holders will incur costs of ($3,542,000) for changes to regulations that affect their package preparation and approval.

Table ES-2 summarizes the net benefits to the NRC, Agreement States, and industry licensees and certificate of compliance (CoC) holders that will result from this rule. The estimate is reported in 2020 dollars and based on a 7 percent discount rate.

Table ES-2 Net Benefits (Costs) by Affected Entity Issu e

No.

Description Alternative 2 Net Benefits ((Costs)-2020 dollars at 7% NPV)

NRC Industry (Licensee)

Industry (CoC Holder)

Agreement States Totala 1

Revision of Fissile Exemptions

$2,907

$2,999,424

$0

$3,002,330

xi Issu e

No.

Description Alternative 2 Net Benefits ((Costs)-2020 dollars at 7% NPV)

NRC Industry (Licensee)

Industry (CoC Holder)

Agreement States Totala 2

Revision of Reduced External Pressure Test for Normal Conditions of Transport

$0

$0 3

Type C Package Standards Not Analyzed Not Analyzed Not Analyzed Not Analyzed Not Analyzed 4

Revision of Insolation Requirements for Package Evaluations

($137,997)

$0

($1,022,551)

$0

($1,160,548) 5 Inclusion of Definition for Radiation Level

$0

$0 6

Deletion of the LSA-III Leaching Test

$0

$59,676

$0

$59,676 7

Inclusion of New Definition for Surface Contaminated Object

$490,489

$468,057

$0

$958,547 8

Revision of Uranium Hexafluoride Package Requirements (UF6 Cylinder Plugs)

($10,792)

$0

($56,340)

$0

($67,132) 9 Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program

($458,544)

($653,356)

($1,432,648)

$0

($2,544,548) 10 Revision of Transitional Arrangements

($612,512)

$0

($1,002,390)

$0

($1,614,902) 11 Inclusion of Head Space for Liquid Expansion

($1,635)

$0

($4,681)

$0

($6,316) 12 Revision of Quality Assurance Program Biennial Reporting Requirements

($1,572)

$0

($23,386)

$0

($24,958) 13 Deletion of Type A Package Limitations in Fissile Material General Licenses

$5,790

$13,173

$0

$18,963 14 Deletion of 233U Restriction in Fissile General License

$0

$1,299,846

$0

$1,299,846 15 Other Recommended Changes to 10 CFR 71.95

$0

($135,223)

Total Operational Costs (by Issue)

($723,866)

$4,186,821

($3,541,997)

($135,223)

($214,265)

Agreement States Implementation Costs

$0

($2,242,429)

Total Benefit (Cost)

($723,866)

$4,186,821

($3,541,997)

($2,377,652)

($2,456,694) a Averted cost = positive, normal cost is (negative)

The estimated net cost of the rule is approximately ($2,457,000). These costs are dominated by industry costs and Agreement State costs to promulgate and implement the rule and revise procedures accordingly. However, the staff determined that a rulemaking is the only option that can meet all regulatory objectives and that will result in net savings to the industry. In addition to the quantified costs and benefits, the final rule is expected to have important benefits that cannot be reliably quantified. These unquantified benefits include labor savings and damages avoided due to (1) harmonization of the NRC regulations in 10 CFR Part 71 with the IAEAs safety standards, thereby reducing the regulatory burden on the licensees by eliminating conflicting requirements, (2) assurance that the NRCs regulations continue to be consistent with the DOT regulations for domestic transportation of radioactive materials, and (3) consistency with the Commissions response to previous revisions and updates of IAEA standards, without any broad programmatic requirements or significant negative impacts on the NRCs licensees or CoC holders. If the value of these unquantified benefits of the rule are considered, the rule is cost justified. One area that the staff did not assess for quantitative benefit is the impact on international commerce over time if the U.S. had regulations that were not compatible with IAEA standards. For example, shipments could be denied or re-routed if U.S. packages are not acceptable in another country. This could be a potentially large cost

xii benefit that could change the rule to quantifiably beneficial. However, due to the unavailability of data, and the staff conclusion that the rulemaking is net beneficial based on qualitative factors, this issue was not assessed.

1 1

Introduction In SECY-16-0093, Rulemaking Plan for Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements, dated July 28, 2016 [8], the U.S. Nuclear Regulatory Commission (NRC) staff requested Commission approval of a rulemaking plan to initiate a rulemaking to (1) harmonize Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, with the transportation safety standards of the International Atomic Energy Agency (IAEA) and the standards of the U.S. Department of Transportation (DOT), and (2) make staff-initiated administrative, editorial, or clarifying changes to 10 CFR Part 71. More specifically, the rulemaking will revise and harmonize the NRCs regulations for packaging and transportation with the IAEAs Specific Safety Requirements (SSR)-6, Revision 1, Regulations for the Safe Transport of Radioactive Material: 2018 Edition, issued 2018 [7]; ensure compatibility with DOT regulations; and make NRC staff-initiated changes. Harmonizing NRC regulations with SSR-6, 2018 Edition, includes changes made in the IAEAs SSR-6, Regulations for the Safe Transport of Radioactive Material: 2012 Edition, issued 2012, that have been carried forward to the 2018 Edition [5]. The Commission approved the NRC staffs recommendation in the related staff requirements memorandum (SRM), SRM-SECY-16-0093, dated August 19, 2016 [9].

The DOT is undertaking a similar rulemaking to harmonize its regulations for the transportation of radioactive material in of Title 49 of the Code of Federal Regulations (49 CFR) Parts 107 and 171-180 with the IAEAs standards in SSR-6, 2018 Edition.

2 Statement of the Problem and Objectives

2.1 Background

The IAEA establishes safety standards to protect public health and safety and to minimize danger to life and property. The IAEA has developed 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. The United States is a Member State, and the DOT is the competent U.S. authority before the IAEA for radioactive material transportation matters. By providing a global framework for the consistent regulation of the transport of radioactive material, SSR-6 [7] facilitates international commerce and contributes to the safe conduct of international trade involving such material. By periodically revising NRC regulations to be compatible with IAEA standards and DOT regulations, the agency is able to remove inconsistencies that could impede international commerce for NRC licensees.

The DOTs and the NRCs roles in coregulating the transportation of radioactive materials are documented in a memorandum of understanding (MOU) dated July2, 1979 [10]. Because the DOT and the NRC coregulate transportation of radioactive materials in the United States, historically, the two agencies have coordinated to harmonize their respective regulations to the IAEA revisions through the rulemaking process. In the NRCs last final rule amending 10 CFR Part 71 (80 FR 33988; June 12, 2015) [1], the NRC stated that the staff will consider any necessary changes related to SSR-6 in a future rulemaking after consulting with the DOT.

The NRC staff engaged with the DOT staff in the development of this regulatory analysis to identify and evaluate gaps between 10 CFR Part 71 regulations and the updated IAEA standards in SSR-6, 2018 Edition. The DOT is undertaking a similar initiative to harmonize its

2 regulations for the transportation of radioactive material in 49 CFR Parts 107 and 171-180 with SSR-6, 2018 Edition.

The NRC reviewed SSR-6, 2018 Edition, and identified 10 regulatory issues for harmonization with 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 an issues paper [11]. A notice of the issues paper, public meeting, and request for comment was published in the Federal Register on November 21, 2016 [12]. 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 prepared [13].

After the public meeting, the NRC received 49 comment submissions on the issues paper and identified comments that are pertinent to the rulemaking action. More recently, the NRC identified other potential changes to clarify the regulations and ensure compatibility with the DOT and Agreement State regulations. These potential changes were grouped under a new issue that was designated as Issue 15.

On April 12, 2019, the NRC published a notice of the draft regulatory basis for this rulemaking in the Federal Register and requested public comments [23]. The NRC 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. Because none of the comments would result in significant changes to the draft regulatory basis, the NRC decided against preparing a final regulatory basis. Instead, the NRC has considered these comments in preparing the final rule.

In the development of this regulatory analysis, the NRC evaluated four alternative actions for each issue: (1) a no-analysis section option that would maintain the status quo (Alternative 1),

(2) issuance of generic communications and regulatory guidance (Alternative 2), (3) issuance of license-specific conditions and exemptions (Alternative 3), and (4) initiation of a rulemaking action to revise 10 CFR Part 71 (Alternative 4). 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 staff recommends the rulemaking action (Alternative 4) for Issues 1 (in part),

2, 4, and 6-15, in combination with the no-action alternative (Alternative 1) for Issue 3, because this represents the best and least costly option. Alternatives 2 and 3 will not address all the regulatory issues or will result in higher costs to the NRC and industry and, therefore, have not been carried forward to the final rule. As a result, this regulatory analysis renames Alternative 4 as Alternative 2. While the NRC is not adopting the IAEAs changes for Issue 5, the staff will clarify the meaning of radiation level. After subsequent evaluation during the development of the final rule, the NRC determined that the no-action alternative (Alternative 1) for Issue 2 is appropriate.

2.2 Statement of the Problem The compatibility of U.S. domestic regulations with international standards provides a consistent basis for the safe packaging and transportation of radioactive material, reduces impediments to trade, facilitates international cooperation, reduces safety risks associated with the import and export of radioactive material, and can be expected to have safety benefits. If the Commission does not pursue rulemaking, this will result in inconsistencies and differences between the NRCs regulations and IAEA standards, as well as DOT regulations. Such inconsistencies and differences can cause uncertainty because of conflicting or duplicative requirements and have negative impacts on both existing and new licensees for domestic transport. Conflicting or duplicative requirements between the NRC and foreign competent authorities can impede

3 international transport. Also, the IAEA has periodically changed its standards to take advantage of increased knowledge and industry experience, and without this harmonization, 10 CFR Part 71 regulations will continue to diverge from the international standards. A decision not to take such action at this time may make harmonization of the NRC regulations with the international standards (and possibly DOT regulations) increasingly difficult over time.

The NRC evaluated two alternative actions to align the NRCs regulations with the IAEA standards: (1) a no-action option that will maintain the status quo (Alternative 1) and (2) a rulemaking option that will revise 10 CFR Part 71 (Alternative 2) and issue DG-7011 to update Regulatory Guide 7.9, Standard Format and Content of 10 CFR Part 71 Applications for Approval of Packages for Radioactive Material [21].

2.3 Objectives Consistent with the NRCs rulemaking process, this regulatory analysis describes and documents the results of assessments and analyses the NRC performed in support of the final rule. The regulatory analysis addresses the regulatory issues (section 2), alternative actions (section 3), cost estimates (section 4 and appendix A), uncertainty analysis (section 5), other impacts and regulatory considerations (section 6), and summary and conclusions (section 7).

The regulatory analysis is supported by appendix A, which provides supporting information for the uncertainty analysis.

3 Discussion of Alternatives 3.1 Action the NRC Is Taking The NRC is amending its regulations to harmonize them with SSR-6, 2018 Edition. These revisions will be consistent with the DOTs hazardous materials regulations, as the DOT is undertaking a similar rulemaking to maintain a consistent framework for the domestic packaging and transportation of radioactive material.

In addition to harmonization with SSR-6, 2018 Edition, this rule will revise 10 CFR Part 71 to include administrative, editorial, and clarification changes, including changes to Agreement State compatibility category designations of certain regulations in order to allow Agreement States to adopt equivalent requirements.

3.2 Applicability of the Action This action will affect (1) NRC licensees authorized by a specific or general license issued by the Commission to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, 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 quality assurance program (QAP) approval. This action also will change regulations that are a matter of compatibility with the Agreement States. Therefore, the Agreement States will need to update their regulations, as appropriate, at which time those licensees located within Agreement States will need to meet the compatible Agreement State regulations.

4 3.3 Changes to NRC Transportation Regulations The NRC is revising its regulations under 10 CFR Part 71 to (1) harmonize and ensure general accord with the IAEA international transportation standards in SSR-6, (2) be compatible with the DOT regulations, and (3) include NRC-staff-initiated changes. These changes will also improve or maintain consistency between 10 CFR Part 71 and DOT regulations under 49 CFR to maintain a consistent domestic framework for packaging and transporting radioactive material.

To accomplish these goals, the NRC is revising 10 CFR Part 71 as described in the following sections.

For each of the issues, this regulatory analysis considers two optionsAlternative 1, the no-action alternative, and Alternative 2, to pursue rulemaking to amend 10 CFR Part 71and describes the advantages and disadvantages of each.

3.3.1 Issue 1. Revision of Fissile Exemptions In 2012, the 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 or conveyance, or both.

The NRC will incorporate SSR-6, 2012 Edition, paragraph 417(c) into a new provision under 10 CFR 71.15, Exemption from classification as fissile material, for 3.5 grams or less uranium-235 (235U), provided the uranium is enriched in 235U to a maximum of 5 percent by weight, and the total plutonium and uranium-233 (233U) content does not exceed 1 percent of the mass of 235U. The NRC will not incorporate the associated consignment limit of SSR-6, 2012 Edition, paragraph 570(c). The NRC will incorporate SSR-6, 2012 Edition, paragraph 417(e), with its associated exclusive use restriction in paragraph 570(e), but with a higher mass limit of 140 grams of fissile material, as an additional fissile exemption under 10 CFR 71.15(g). The NRC will not incorporate the fissile exception in SSR-6, 2012 Edition, paragraph 417(d).

Alternative 1: No-Action Alternative Under the no-action alternative, the two additions to the 10 CFR Part 71 fissile exemptions described in Issue 1.a will not be made. Licensees wishing to ship the amounts of fissile material described in these changes will have to submit an application for a Type AF or B(U)F/B(M)F package and demonstrate that the package meets the criticality safety requirements of 10 CFR 71.55, General requirements for fissile material packages, and 10 CFR 71.59, Standards for arrays of fissile material packages. This alternative will leave the fissile-exempt material requirements in 10 CFR 71.15 unchanged, and these requirements will not be harmonized with similar requirements in SSR-6, 2018 Edition.

Alternative 2: Revise 10 CFR Part 71 Under Alternative 2, the final rule will codify the fissile exemption changes in 10 CFR 71.15; it will be clear to all current and future licensees, applicants, and staff that the NRC considers this material to be subcritical without a demonstration of compliance with 10 CFR 71.55 and 10 CFR 71.59. Additionally, the changes will meet the intent of the fissile exemptions, in that licensees could self-certify packages for shipping the amount of material described in the two changes. If the NRC were to move forward with the rulemaking, the fissile exemptions in 10 CFR 71.15 would be more consistent with similar provisions in SSR-6 paragraph 417. Since

5 harmonization with SSR-6, to the extent described above, facilitates the safe transportation of fissile material internationally, the staff recommends performing the rulemaking.

3.3.2 Issue 2. Revision of Reduced External Pressure Test for Normal Conditions of Transport The NRC decided not to pursue any changes to the reduced external pressure test requirement under 10 CFR 71.71(c)(3). As a result, this regulatory analysis presents no further discussion or analysis on that issue.

3.3.3 Issue 3. Type C Package Standards The NRC decided not to pursue any changes to 10 CFR Part 71 to adopt Type C package standards. The agency decided not to adopt Type C package standards because the U.S.

regulations in 10 CFR 71.64, Special requirements for plutonium air shipments, and 10 CFR 71.71, Normal conditions of transport, governing plutonium air transportation to, within, or over the United States contain more rigorous packaging standards than those in IAEA SSR-6. As a result, this regulatory analysis presents no further discussion or analysis on that issue.

3.3.4 Issue 4. Revision of Insolation Requirements for Package Evaluations During transport, a package is subjected to heating by the sun (i.e., insolation). The effect of insolation is to increase the package temperature. The NRC is changing the regulatory requirements for (1) the unit of measure for the values of insolation in the INSOLATION DATA table in 10 CFR 71.71(c)(1) for the heat test for normal conditions of transport, and (2) the initial conditions for the tests for hypothetical accident conditions in 10 CFR 71.73(c)(4).

3.3.4.1 Issue 4.1 Unit of Measure for Insolation for Normal Conditions of Transport The NRC previously harmonized its regulations with SSR-6, 1985 Edition [29]. That final rule neither discussed nor proposed changing the units on the heat test for normal conditions of transport in 10 CFR 71.71(c)(1). Consequently, the current units for insolation in 10 CFR Part 71 are gram-calories per square centimeter (g cal/cm2). This is inconsistent with IAEA standards in SSR-6, 2018 Edition. As a result, NRC package approvals are evaluated for less insolation than prescribed by IAEA standards and required by foreign competent authorities.

In order to be used for international transport, NRC-approved packages must be issued a certificate of competent authority from the DOT. For NRC-approved packages, the DOT issues certificates of competent authority based on the NRC CoC. The amount of insolation evaluated in the thermal evaluation for packages approved by the DOT for international transport, as reviewed by the NRC, is less than the values in SSR-6, 2018 Edition.

Alternative 1: No-Action Alternative In considering the no-action alternative, since the NRC values for insolation are lower than the equivalent values in SSR-6, 2018 Edition, applicants for a transportation CoC can voluntarily use the IAEA values and still meet the Commissions requirements. However, absent a rule change, the NRC cannot require certificate holders to use the higher IAEA values. Evaluating a package to the lower values may necessitate a different thermal evaluation using the higher IAEA values in SSR-6, 2018 Edition, if requested by a foreign competent authority when

6 reviewing a DOT certificate of competent authority for revalidation for international transportation.

Alternative 2: Revise 10 CFR Part 71 Under this alternative, the NRC will revise the units for insolation for the heat test for normal conditions of transport in 10 CFR 71.71(c)(1) to be consistent with those of the IAEA.

Performing the rulemaking will ensure that thermal analyses performed for package approval in the United States have the same conditions as those that use IAEA standards for normal conditions of transport. Since regulatory consistency will be achieved, performing the rulemaking is the preferred alternative.

3.3.4.2 Issue 4.2 Initial Conditions for Hypothetical Accident Conditions In IAEA Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1985 Edition (as amended in 1990) [24], paragraph 628 states the following:

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. [Emphasis in the original.]

The thermal test, previously in paragraph 628, was moved to paragraph 728 in Regulations for the Safe Transport of Radioactive Material: 1996 Edition (Revised) (TS-R-1, 1996 Edition) [25],

and revised to state the following:

The specimen shall be in thermal equilibrium under conditions of an ambient temperature of 38°C, subject to the insolation conditions specified in Table XI and subject to the design maximum rate of internal heat generation within the package from the radioactive contents. [Emphasis in the original.]

When the NRC revised its regulations in 2004 to harmonize with the 1996 IAEA standard [26],

the NRC did not revise the initial conditions of the fire test listed in 10 CFR 71.73(c)(4) to explicitly require evaluation of insolation as an initial condition.

Alternative 1: No-Action Alternative In the no-action alternative, the NRC will not move forward with the rule but will continue to confirm during application review that applicants for a CoC evaluate insolation as a precursor to the fire test. The disadvantage is that the regulations will not explicitly state that insolation is an initial condition to the fire test and NRC regulations will not be harmonized with the IAEA standards for transport of radioactive material.

Alternative 2: Revise 10 CFR Part 71 Under this alternative, the NRC will undertake a rulemaking to require insolation as an initial condition to the fire test in 10 CFR 71.73(c)(4) for hypothetical accident conditions. The regulation will be consistent with SSR-6, 2018 Edition, and with requirements in use by other foreign competent authorities, obviating the need for questions about whether insolation was

7 considered in the initial conditions of the tests for hypothetical accident conditions. Since regulatory consistency will be achieved, performing the rulemaking is the preferred alternative.

3.3.5 Issue 5. Inclusion of a Definition for Radiation Level In SSR-6, 2018 Edition, the IAEA replaced the term radiation level with the term dose rate, which was defined as the dose-equivalent per unit time. However, making this change will result in cost impacts on licensees to change documentation and potentially training programs, with no safety benefit. Therefore, in order to minimize the burden to licensees, the NRC will clarify the term radiation level by adding a definition to 10 CFR 71.4, Definitions. The NRC is not expecting any licensees to change their documentation due to this new definition.

Alternative 1: No-Action Alternative The no-action alternative will not change the regulations or guidance. Since this is solely an issue of what to name the dose rate measurements and calculations, there will be no impact to safety by choosing this option.

Alternative 2: Revise 10 CFR Part 71 Under Alternative 2 the NRC will add a definition for radiation level to state that it means the radiation dose equivalent rate expressed in millisieverts per hour or mSv/h (millirems per hour or mrem/h), to ensure that it is clear that the dose rates for NRC-approved packages will meet the dose rate criteria in SSR-6 for approval by foreign competent authorities. Since regulatory consistency will be achieved, performing the rulemaking is the preferred alternative.

3.3.6 Issue 6. Deletion of the Low Specific Activity-III Leaching Test The qualification tests in 10 CFR 71.77, Qualification of LSA-III material, for Low Specific Activity (LSA) Category III (LSA-III) material 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. Consequently, the NRC is revising 10 CFR 71.77 and making corresponding revisions to 10 CFR 71.4 and 10 CFR 71.100, Criminal penalties, to remove reference to the leaching test.

Alternative 1: No-Action Alternative The no-action alternative will not change the regulations and the leaching test will remain in 10 CFR 71.77. Retaining the status quo will result in an inconsistency between the NRC regulations and the international standard in SSR-6 for this issue. Additionally, the DOT is undertaking a rulemaking to remove the LSA-III leaching test from its regulations under 49 CFR.

If the DOT removes the leaching test and the NRC retains it, this will result in an inconsistency in the domestic regulations for this issue. These regulatory inconsistencies will have a negative impact on the users of the collective domestic transportation regulations (i.e., 10 CFR and 49 CFR).

Alternative 2: Revise 10 CFR Part 71 In an effort to assure international transportation of all types of radioactive material, especially LSA material, the NRC will harmonize 10 CFR Part 71 with both the DOT regulations and SSR-6 international standards. Through harmonization with the DOT and the IAEA, the LSA-III

8 leaching test will be removed from 10 CFR Part 71. Revising 10 CFR Part 71 to remove the LSA-III leaching test will also reduce the burden on and avert costs for shippers of radioactive material due to the regulatory relief that is achieved by deleting this test requirement for LSA-III material.

An international working group concluded that the then-currently required leaching test for LSA-III material did not contribute to the 50 mSv effective dose transport safety limit. Therefore, the working group recommended to the Transport Safety Standards Committee 30 that the leaching test is not necessary or justified and its removal from the transport requirements is appropriate. Thus, the removal of the LSA-III leaching test from SSR-6 benefited from technical and health physics considerations, and the Transport Safety Standards Committee 30 decided to remove the test from the transport regulations. The staff recognizes the working groups information and is recommending harmonizing the NRCs regulations with SSR-6, 2018 Edition, and removing the leaching test from 10 CFR Part 71.

3.3.7 Issue 7. Inclusion of New Definition for Surface Contaminated Object (SCO-III)

Decommissioning activities can include transporting large radioactive objects (e.g., steam generators, coolant pumps, and pressurizers). Although 10 CFR 71.41(d) allows for special package authorization of one-time type shipments, the NRC also recognizes that it needs time to complete such an authorization. The NRC and licensees will gain efficiencies by having a regulatory definition for a third category of large surface contaminated objects (SCOs).

Currently, the regulations in 10 CFR 71.4 contain two definitions for SCO: SCO-I and SCO-II.

Harmonization with SSR-6, 2018 Edition, will add the new SCO-III category and the associated definition.

The NRC will include a definition of SCO-III in 10 CFR 71.4. The NRC is coordinating with the DOT to align on a definition for SCO-III that the DOT will similarly adopt as part of its harmonization rulemaking.

Alternative 1: No-Action Alternative The no-action alternative will not add a definition for SCO-III to 10 CFR Part 71. This will create a discrepancy between the NRC regulations and SSR-6. Furthermore, the DOT is undertaking a rulemaking to add SCO-III to 49 CFR. If the DOT adds an SCO-III definition and the NRC does not, a regulatory inconsistency will result for this issue, necessitating NRC review under 10 CFR 71.41(d) of shipments that can be self-certified and transported under DOT regulations.

Additionally, the NRC already includes definitions for the related categories SCO-I and SCO-II, consistent with the DOT and the IAEA.

Alternative 2: Revise 10 CFR Part 71 In an effort to ensure domestic and international transportation of all types of radioactive material, and most especially of large radioactive objects, the NRC will harmonize 10 CFR Part 71 with SSR-6 and DOT regulations by adding the definition of SCO-III to 10 CFR 71.4.

The 1979 NRC/DOT MOU delineates that the DOT has regulatory authority for LSA material. At the time this MOU was signed, the SCO categories did not exist. However, within the DOT regulations at that time, provisions existed for transporting items that were externally contaminated. Currently, the DOT is the lead agency for both LSA material and SCO. Within

9 49 CFR 173.427, Transport requirements for low specific activity (LSA) Class 7 (radioactive) material and surface contaminated objects (SCO), the DOT provides the transportation requirements for LSA material and SCO. The DOT is undertaking a rulemaking to update 49 CFR (specifically 49 CFR 173.403, Definitions, and 49 CFR 173.427) to include the SCO-III definition and transportation requirements.

3.3.8 Issue 8. Revision of Uranium Hexafluoride Package Requirements In 2004, the NRC added a new provision in 10 CFR 71.55(g) to provide a specific exception for certain uranium hexafluoride (UF6) packages from the requirements of 10 CFR 71.55(b). The exception allows UF6 packages to be evaluated for criticality safety without considering in-leakage 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 235U. In order to use this exception, the applicant must demonstrate that, following the tests for hypothetical accident conditions in 10 CFR 71.73, Hypothetical accident conditions, there is, as stated in 10 CFR 71.55, 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.

In SSR-6, 2018 Edition, the IAEA added the same requirement for the plug as was added in TS-R-1, 1996 Edition, for the valve to ensure that the entire cylinder remains leaktight. In order to ensure criticality safety, both the plug and the valve must remain leaktight after the tests for hypothetical accident conditions, to prevent ingress of water into the cylinder.

Alternative 1: No-Action Alternative In the no-action alternative, under the existing requirements in 10 CFR 71.55(g), the NRC will not require that the plug remain leak tight after the tests for hypothetical accident conditions. In this alternative, the NRC criticality safety requirement for moderator exclusion for UF6 cylinders will be different from that of the IAEA and other IAEA Member States that have adopted the IAEA requirement; therefore, foreign competent authorities may question certificate holders about whether the plug on an NRC-approved package remains leak tight after the tests for hypothetical accident conditions.

Alternative 2: Revise 10 CFR Part 71 The preferred alternative is to perform the rulemaking and revise 10 CFR 71.55(g)(1) to require that there is no contact between the cylinder plug and any other part of the package, other than at its original attachment point, and that the cylinder plug remains leak tight after the tests for hypothetical accident conditions. This will ensure that the 30B cylinder in NRC-approved packages, which is used worldwide for transport of large quantities of UF6 enriched up to 5 weight percent, will be consistent with SSR-6 and have the same approval basis as required by other competent authorities.

3.3.9 Issue 9. Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program In paragraph 613A of SSR-6, the IAEA added a requirement that package design evaluations should evaluate aging mechanisms. Paragraph 809 of SSR-6 requires that the application for package approval contain a maintenance program. While NRC regulations do not specifically require evaluation of the effects of aging, 10 CFR 71.43(d) requires no significant chemical, galvanic, or other reaction among the packaging components, among package contents, or between the packaging components and the package contents. The inclusion in the application

10 of an evaluation of the effects of aging mechanisms and the quantified effect of aging degradation on package component performance can determine whether aging management activities need to be included in the maintenance program. Such aging management activities may include periodic inspections to evaluate the material condition of components, periodic tests to evaluate component performance, repair or replacement schedules, or some combination of these things.

The maintenance program chapter in the application includes periodic testing requirements, inspections, and replacement criteria and schedules for replacement and repair of components on an as-needed basis to ensure that the package components meet the requirements related to aging in 10 CFR 71.43(d). Following the maintenance program contained in the application provides assurance that the effects of aging will be minimized, and the packaging will perform as intended throughout its time in service.

Alternative 1: No-Action Alternative In the no-action alternative, the NRC will not move forward with the rulemaking and, consistent with NRC regulations in 10 CFR 71.43(d), will continue to verify in package certificate reviews that applicants for a CoC evaluate the potential effects of chemical, galvanic, and other reactions on package components and contents. The disadvantage of this alternative is that the regulations will not explicitly require evaluation of aging and a description of the maintenance program in the application.

Alternative 2: Revise 10 CFR Part 71 Under this alternative, the NRC will make its regulations consistent with SSR-6 by requiring applications for package approval to contain a description of the maintenance program and a documented evaluation of the effects of aging mechanisms on package component performance. Consistent regulations will ensure that there is a consistent worldwide regulatory framework for radioactive material transport. Performing the rulemaking is the preferred alternative because it will achieve consistency; it will ensure adequate evaluation of the effects of aging mechanisms on package component performance; and it will ensure the maintenance program includes provisions for adequate management of the effects of aging mechanisms on package component performance.

3.3.10 Issue 10. Transitional Arrangements Historically, IAEA, DOT, and NRC regulations have included transitional arrangements or provisions that allow certain licensees that have been operating under the previous version of the regulations to continue to do so, whenever the regulations have undergone revision. The purpose is to minimize the costs and impacts of implementing changes in the regulations, since package designs compliant with 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 packaging already fabricated, and completion of packagings in the process of being fabricated, although some restrictions on fabrication of packages 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 manufacture and use of special form sources approved to earlier versions of the regulations.

11 The IAEA updated its transitional arrangements in paragraphs 819-823 of SSR-6, 2018 Edition.

In addition, the DOT is undertaking a rulemaking to harmonize its transitional arrangements with those of the IAEA.

Alternative 1: No-Action Alternative In the no-action alternative, the NRC will not make any rule changes. Packages approved to the NRCs regulations harmonized with the Safety Series No. 6 standard, 1973 Edition [27], will not be phased out; there will be no further restrictions to packages with a -85 or -96 in the package identification number; and the NRC will not be able to issue CoCs that are consistent with SSR-6, 2018 Edition.

While the NRC will continue to authorize use of packages approved to regulations that are harmonized with the 1973 version of IAEA standards for domestic use (i.e., packages without a

-85 or -96 in the package identification number), assuming the DOT completes its rulemaking, these packages will not be able to be transported internationally without obtaining a special package authorization from the DOT, the country of origin or destination (depending on whether it is an import or export shipment to or from the United States), and, as appropriate, all countries that the package will pass through. It is not clear whether other countries will be willing to issue a special authorization for every one of these shipments using older package designs.

The NRC will not revise its definition of special form radioactive material, resulting in inconsistent regulations on the manufacture and use of special form radioactive material between the NRC and the DOT. Under this alternative, special form radioactive material that was approved after September 30, 2004, and fabricated after December 31, 2025, will be authorized for transport under NRC regulations but will not be authorized for transport under DOT regulations.

Finally, for existing certificates issued by the NRC, consistent with 10 CFR 71.19(d), the package identification number will continue to have a -96 in it, even if the applicant evaluated the package against the standards in SSR-6, 2018 Edition. If the NRC were to continue to add a

-96 in the package identification, this will place restrictions on the ability of the certificate holder to fabricate and use these packages in international shipment as described above.

As the competent authority in the United States for the transportation of radioactive material, if the DOT harmonizes its regulations for transitional arrangements with those of the IAEA and the NRC does not, then the NRC regulations for domestic transport of radioactive material will not be consistent with DOT regulations. This inconsistency could cause confusion among NRC licensees as to whether their package is authorized for only domestic transport, international transport, or both, and whether it can be fabricated and used domestically. If the regulations in 10 CFR 71.19(d) are not revised and the NRC is not able to issue certificates under NRC regulations harmonized with SSR-6, 2018 Edition, after December 31, 2025, then any licensee that desires to ship radioactive material internationally will have to request a special permit from the DOT, and NRC licensees will have to request an exemption from the NRC. (State licensees will need to request an exemption from their state regulatory body.) NRC licensees will request an exemption from the NRC requirements in 10 CFR 71.19(d) to obtain package approvals under the latest version of SSR-6. These actions will be needed for each package, from each licensee using the package for import/export, rather than from certificate holders.

12 Alternative 2: Revise 10 CFR Part 71 The rulemaking will make transitional arrangements in 10 CFR Part 71 consistent with the IAEA standards, as follows:

Phase out the use of packages approved to NRC regulations that were harmonized with the IAEAs Safety Series No. 6, 1973 Revised Edition, 15 years after the effective date of this rulemaking. These packages will be required to be recertified, removed from service, or used via exemption.

Packages with a -96 in the package identification number that are to be used for international shipments require multilateral approval, as defined in 49 CFR 173.403.

Revise 10 CFR 71.17(e) to state that packages with a -96 in the package identification number will become previously approved packages and subject to the current 10 CFR 71.19(c) regulations.

Coordinate with the DOT and make appropriate changes to 10 CFR 71.4 to align with the definition of special form radioactive material that the DOT adopts as part of its harmonization rulemaking, since the DOT is the lead for certifying special form sources.

Revise 10 CFR 71.19(e) to allow for previously approved package designs (i.e., packages with an -96 or earlier 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.

Performing the rulemaking is the preferred alternative because it will ensure consistent regulations between the NRC and the DOT, and with the IAEA standard, for domestic and international transport of radioactive material.

3.3.11 Issue 11. Inclusion of Head Space for Liquid Expansion The NRCs regulations in 10 CFR 71.87, Routine determinations, require, in part, the following:

Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this part and of the license. The licensee shall determine that

[]

(d)

Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid.

The NRC does not have a design requirement for Type AF and Type B packages in 10 CFR Part 71 comparable to those in the DOTs regulations in 49 CFR 173.412(k) for Type A packages or SSR-6, 2018 Edition, paragraph 649 (for Type A packages), paragraph 652 (for Type B(U) packages), and paragraph 667 (for Type B(M) packages).

The NRC will add a design requirement to ensure that package components that contain liquid have sufficient head space for liquid expansion under the tests for normal conditions of transport and hypothetical accident conditions.

13 Alternative 1: No-Action Alternative In the no-action alternative, the NRC will not modify its regulations to add a design requirement in 10 CFR Part 71 to ensure sufficient head space for systems containing liquid. The NRC will continue to ensure that package operating procedures comply with the requirements in 10 CFR 71.87(d) to include provisions to allow adequate head space for liquid expansion. The disadvantage to this alternative is that the NRC regulations will not have a compatible regulation for adequate head space for Type AF packages and Type B packages as the DOT does for Type A packages. Therefore, this is not the desired option, since NRC design regulations for Type AF and Type B packages containing liquids will be different from DOT regulations and IAEA standards. The conflicting regulations reduce clarity for regulators and any operator attempting to comply while undertaking an activity covered by the regulations. The consequences of reduced clarity may include that packages that have varying designs will not meet the requirements.

Alternative 2: Revise 10 CFR Part 71 Rulemaking will revise 10 CFR 71.43, General standards for all packages, to add a design requirement for a package designed to contain liquids to ensure adequate ullage is maintained during evaluation of the tests and conditions for normal conditions of transport and hypothetical accident conditions. Rulemaking will ensure that during the design phase, the NRC staff will have consistent regulations between the NRC and the DOT, and with the IAEA standard, for domestic and international transport of packages containing liquids and not have to rely on operational regulations to ensure adequate volume for filling containers holding liquids.

3.3.12 Issue 12. Revision of Quality Assurance Program Biennial Reporting Requirements On June 12, 2015, the NRC issued a final rule to amend 10 CFR Part 71 and added 10 CFR 71.106, Changes to quality assurance program, to establish requirements that applied to changes to QAPs and included associated requirements to report to the NRC. According to the language in the preamble of the 2015 final rule (80 FR 33988), if no changes were made to the QAP in the preceding 24 months, the NRC will expect a report to be submitted stating no changes were made. In addition, the NRCs guidance document for 10 CFR Part 71 QAPs, Regulatory Guide (RG) 7.10, Revision 2, Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material, issued March 2005 [28], states that if no changes were made to the QAP, a QAP approval holder will indicate to the NRC that no changes were made. The requirement for a report if no changes were made during the preceding 24-month period was intended to be included in 10 CFR 71.106 as part of the 2015 final rule, but the actual regulation was silent on this point.

The NRC will revise 10 CFR 71.106(b) to achieve the agencys stated intent in the 2015 final rule: a biennial report must be submitted to the NRC if no changes are made to the QAP during the reporting period.

Alternative 1: No-Action Alternative In the no-action alternative, the NRC will not modify its regulations in 10 CFR 71.106(b) to clarify that a biennial report must be submitted to the NRC if no changes are made to the QAP during the reporting period. The regulatory uncertainty will continue to exist because of the

14 inconsistency between the current regulatory language in 10 CFR 71.106(b) and RG 7.10 guidance.

Alternative 2: Revise 10 CFR Part 71 Under this alternative, the NRC will perform the rulemaking to remove regulatory uncertainty, achieve the NRCs stated intent in the 2015 final rule, and ensure consistency between the rule language in 10 CFR Part 71 and regulatory guidance. The NRC inspection program for 10 CFR Part 71 QAP approval holders also relies on having current information about the QAP available to the NRC. As such, the 24-month reporting period for either changes or no changes made to the QAP is considered to provide an appropriate balance between the burden placed on the QAP approval holders and the need to ensure that the NRC has that current information.

Another benefit is that the revised QAP reporting requirements in 10 CFR Part 71 will be consistent with those in 10 CFR 50.54(a)(3) and 10 CFR 50.71(e)(2) for QAPs under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.

3.3.13 Issue 13. Deletion of Type A Package Limitations in Fissile Material General Licenses The general license criteria in 10 CFR 71.22, General license: Fissile material, and 10 CFR 71.23, General license: Plutonium-beryllium special form material, are intended to 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 10 CFR 71.22 and 10 CFR 71.23 require that the material is in a Type A package meeting the requirements of 49 CFR 173.417(a) and that there is no more than a Type A quantity of radioactive material. 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.

The NRC will remove the restriction in 10 CFR 71.22 and 10 CFR 71.23 to ship Type A material in only a Type A package (i.e., allowing shipment in a Type B package), which will correct the inconsistences between the mass limits and package restrictions discussed above. Additionally, the NRC will clarify language in 10 CFR 71.23 to ensure that it is clear that this regulation only applies to special form plutonium-beryllium sources. The existing rule language refers to 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. For example, 10 CFR 71.23 only applies to sealed sources that meet this definition.

Alternative 1: No-Action Alternative Under the no-action alternative, the NRC will not make changes to 10 CFR 71.22 and 10 CFR 71.23, and licensees will continue to be limited to shipping less than the mass limits cited in these regulations for some fissile radionuclides because of the Type A quantity and packaging limitation. Additionally, it may continue to be unclear that sealed sources that do not meet the definition of special form material in 10 CFR 71.4 are not authorized under 10 CFR 71.23.

Alternative 2: Revise 10 CFR Part 71 Under Alternative 2, licensees could ship higher amounts of material under the general licenses in 10 CFR 71.22 and 10 CFR 71.23, up to the amounts already determined to be safe in

15 calculations that support the existing mass limits. Additionally, the changes will meet the intent of the general license provisions, which is that the amount of material represented by the mass limits in 10 CFR 71.22 and 10 CFR 71.23 is safe to ship with a package CSI determined using the equations in each provision. The three new paragraphs in 10 CFR 71.22 and 10 CFR 71.23 and the conforming changes to 10 CFR 71.0(d)(1) will also ensure similar requirements for licensees using these general licenses as in 10 CFR 71.17(c), (d), and (e). If the NRC were to move forward with the rulemaking and allow general license quantities of fissile material to be shipped in a Type B package, then 10 CFR 71.22 and 10 CFR 71.23 will be consistent with the intent of the general licenses. Because this change will facilitate the safe transportation of small quantities of fissile material without explicit NRC approval, thereby enhancing regulatory efficiency, performing the rulemaking is the staffs recommended alternative. Additionally, the intent of 10 CFR 71.23 will be clarified to ensure that sealed sources that do not meet the definition of special form material in 10 CFR 71.4 are not authorized for shipment under this provision.

3.3.14 Issue 14. Deletion of 233U Restriction in Fissile General License Users of the general license in 10 CFR 71.22 assign a CSI for a fissile material package based on the equation in 10 CFR 71.22(e)(1) and the fissile mass limits in either Table 71-1, Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment per § 71.22(e), or Table 71-2, Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment per § 71.22(e). Table 71-2 contains mass limits for shipping uranium enriched to various weight percent levels in 235U.

However, 10 CFR 71.22(e)(5) states 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 1 percent of the mass of 235U, or if 233U is present in the package.

The isotope 233U is not present in natural uranium but may be present in very low concentrations in some facilities that may have handled 233U in the past. These contamination-level concentrations, while detectable with modern isotopic assay methods and physically present, are not important for the criticality safety of 235U transportation. The calculations used to support the enrichment limit for 10 CFR 71.15(d), for up to 1.0 weight percent enriched uranium, demonstrate that this limit is safe provided the plutonium and 233U are limited to less than 1 percent of the 235U. The same limitation could be applied to the use of Table 71-2 limits for shipping enriched uranium under 10 CFR 71.22, without affecting criticality safety. The NRC is revising 10 CFR 71.22 to limit the 233U to less than 1 percent of the mass of 235U, similar to the provision limiting plutonium in 10 CFR 71.22(e)(5)(ii).

Alternative 1: No-Action Alternative Under the no-action alternative, the NRC will not make changes to 10 CFR 71.22 and licensees will continue to be restricted to shipping lower masses of enriched uranium under the Table 71-1 limits, even though the amount of 233U in the material is negligible (but physically detectable).

Alternative 2: Revise 10 CFR Part 71 Under this alternative, licensees could ship larger amounts of material under the general license in 10 CFR 71.22, up to the amounts determined to be safe in calculations that support the mass limits in Table 71-2. Additionally, the change will meet the intent of the general license provisions, which is that the amount of 233U in the package should be low enough to maintain the validity of the enrichment limits in Table 71-2, which were based on calculations with 235U

16 systems. If the NRC were to proceed with the rulemaking and allow Table 71-2 mass limits to be used for uranium with 233U mass up to 1 percent of the mass of 235U, 10 CFR 71.22 will remain consistent with the intent of the general license while allowing greater quantities of fissile material to be shipped under this provision. This change will facilitate the safe transportation of small quantities of fissile material without explicit NRC approval, thereby enhancing regulatory efficiency.

3.3.15 Issue 15. Other Recommended Changes to 10 CFR Part 71 3.3.15.1 Issue 15.1 Delete Duplicative Reporting Requirements in 10 CFR 71.95 In its final rule dated January 26, 2004 [26], the NRC added paragraph (a)(3) to 10 CFR 71.95, Reports, which introduced duplicative language between paragraph (a)(3) and paragraph (b).

The NRC will delete the text in paragraph (a)(3).

Alternative 1: No-Action Alternative Under the no-action alternative, the NRC will not delete the requirements in 10 CFR 71.95(a)(3).

NRC licensees will be required by both 10 CFR 71.95(a)(3) and 10 CFR 71.95(b) to submit a report when a shipment occurred and the conditions of approval in the CoC were not followed.

Alternative 2: Revise 10 CFR Part 71 Revising 10 CFR Part 71 to delete 10 CFR 71.95(a)(3) will not change the reporting requirements for licensees that perform a shipment that is not in accordance with the regulations, since reporting will still be required under 10 CFR 71.95(b). However, this alternative will remove the duplicative requirement.

3.3.15.2 Issue 15.2 Revise the Definition of LSA in 10 CFR 71.4 The NRC is modifying the first sentence in the definition of low specific activity (LSA) material in 10 CFR 71.4 to change excepted under 10 CFR 71.15 to exempted under 10 CFR 71.15.

This change will make the definition of LSA in 10 CFR 71.4 consistent with the title and intent of 10 CFR 71.15.

Alternative 1: No-Action Alternative Under the no-action alternative, the definition of LSA material will continue to be inconsistent with the title and intent of 10 CFR 71.15. This inconsistency could lead to confusion over the difference in terms.

Alternative 2: Revise 10 CFR Part 71 Under this alternative the definition of LSA will be consistent with the title of 10 CFR 71.15 and 10 CFR Part 71 will be more internally consistent. Also, there will be less potential confusion regarding the intent of the definition of LSA regarding fissile exempt material.

17 3.3.15.3 Issue 15.3 Revise the A1 and A2 Values and the Exempt Material Activity Concentrations and Exempt Consignment Activity Limits The IAEA has made changes in SSR-6, 2018 Edition, related to the A1 and A2 activity values and the exempt material activity concentrations and exempt consignment activity limits. The DOT is the lead agency for information related to the A1 and A2 values and for the exempt material activity concentrations and exempt consignment activity limits, as provided in 49 CFR 173.435, Table of A1 and A2 values for radionuclides, and 49 CFR 173.436, Exempt material activity concentrations and exempt consignment activity limits for radionuclides, respectively. The NRC has corresponding information in 10 CFR Part 71, Appendix A, Tables A-1 and A-2.

In its concurrent harmonization rulemaking, the DOT will make changes to 49 CFR 173.435 and 49 CFR 173.436 by adding seven radionuclides: barium-135m, germanium-69, iridium-193m, nickel-57, strontium-83, terbium-149, and terbium-161. The NRC is making changes to 10 CFR Part 71, Appendix A, by removing Tables A-1 through A-4 and associated footnotes and will reference the information in DOT regulations. The tables and footnotes are identical between the NRC and DOT regulations, but errors have been introduced in the past. Revising Appendix A to remove the duplicative information from the NRC regulations and referencing the DOT regulations removes the possibility for future error.

Alternative 1: No-Action Alternative Under the no-action alternative, if the DOT adds the seven radionuclides to its regulations and the NRC does not, then the regulations for domestic transport will be inconsistent. It is possible that under DOT regulations, a shipment of one of the seven new radionuclides may need to take place in a Type A package. However, if the NRC does not have one of the radionuclides in Table A-1, then a licensee will use the more restrictive A values in Table A-3 and have to make the shipment in an NRC-approved Type B package.

Similarly, if the DOT adds the seven radionuclides to its regulations for the exempt material activity concentrations and exempt consignment activity limits and the NRC does not, then under DOT regulations, a shipment containing one or more of the radionuclides may not be subject to the hazardous materials regulations in 49 CFR Parts 171-180. However, under NRC regulations, it may be subject to the hazardous material regulations based on the more restrictive values in Table A-3 in 10 CFR Part 71.

Alternative 2: Revise 10 CFR Part 71 The NRC will revise Appendix A to 10 CFR Part 71 to remove Tables A-1 through A-4 and instead reference DOT regulations that contain the same information to ensure consistent domestic regulations for transporting radioactive material. This will preclude the use of a Type B package for shipments involving certain quantities of any of these seven radionuclides.

3.3.15.4 Issue 15.4 Revision to Agreement State Compatibility Categories Revise the compatibility category designations for the regulations containing QAP requirements for those Agreement States that have licensees that use Type B packages for shipping radioactive materials, other than for industrial radiography operations, or have licensees that ship using the general license in 10 CFR 71.21, General license: Use of foreign approved package; 10 CFR 71.22; or 10 CFR 71.23, which also requires an approved QAP. This will give

18 the Agreement States the appropriate authority to approve, inspect, and enforce against all the necessary regulations that specify the criteria for a QAP required for those licensees that use Type B packages, other than for industrial radiography use, or for those that ship using the general license in 10 CFR 71.21, 10 CFR 71.22, or 10 CFR 71.23.

The NRC is changing the compatibility category for 10 CFR 71.95(a) to Compatibility Category C in order to have Agreement State regulations require their licensees to notify the Agreement State regulator (who, in turn, would then notify the NRC) if a package is found to have a defect or significant reduction in effectiveness so that others using the package can be made aware of the situation. The NRC is revising the compatibility category for 10 CFR 71.95(b) to Compatibility Category C so that Agreement States will get feedback on the effectiveness of the QAPs that they approve. In addition, since 10 CFR 71.95(c) and (d) include requirements for the content and legibility of the report, the NRC is revising them to Compatibility Category C, so that the reports sent to the Agreement States and the NRC contain the same information.

Alternative 1: No-Action Alternative Under the no-action alternative, the Agreement States will not have the appropriate authority to approve, inspect, and enforce the regulations related to a QAP for those licensees that use Type B packages, other than for industrial radiography, or for those licensees that ship using the general license in 10 CFR 71.21, 10 CFR 71.22, or 10 CFR 71.23. This has potential health and safety consequences. For example, if a licensee does not have an adequate QAP, a shipment of Type B quantities of radioactive material could be sent in a defective package, causing exposures to personnel and the public. The use of these packages will not be fully inspectable, and the Agreement State radiation control program could not enforce against all the necessary regulations. There also could be potential conflicts, duplications, and gaps in the regulation of the use of these packages across the Nation.

In addition, Agreement State licensees will not be required to send reports to the NRC as required by 10 CFR 71.95(a) for instances in which a package is found to have a defect or significantly reduced effectiveness. The NRC will not know whether a package being used by an Agreement State licensee had a defect or significant reduction in its effectiveness, without the State licensee voluntarily reporting it. Agreement State regulators will not receive reports required by 10 CFR 71.95(b) of instances in which their licensees used an NRC-approved package in a manner that does not comply with the NRC CoC. This will not give Agreement State regulators feedback on the effectiveness of QAPs that they approve for their licensees.

Alternative 2: Revise 10 CFR Part 71 The NRC is revising the Agreement State compatibility categories, and State licensees will have to send reports required by 10 CFR 71.95(a) to the NRC for instances in which an NRC-approved package, including industrial radiography devices, is found to have a defect or significant reduction in effectiveness. The NRC will be able to assess the issue and discuss with the certificate holder if other users should be notified of the issue to ensure safe transport of NRC-approved packages. In addition, the NRC will revise the compatibility category for 10 CFR 71.95(b) from a Compatibility Category D to a Compatibility Category C so that Agreement State regulators will be able to evaluate the effectiveness of QAPs they approve for their licensees since they will receive reports required by 10 CFR 71.95(b) of instances in which their licensees used an NRC-approved package in a manner that does not comply with the NRC CoC.

19 In addition, Agreement States will be able to approve and inspect those shipments against all the applicable QA requirements and perform enforcement actions, as necessary.

3.3.15.5 Issue 15.5 Address Redundancies in Advance Notification Requirements of 10 CFR 71.97 with Requirements of 10 CFR Part 37 and 10 CFR Part 73 The NRC is modifying 10 CFR 71.97, Advance notification of shipment of irradiated reactor fuel and nuclear waste, to remove references to irradiated reactor fuel to delete duplicative reporting requirements between it and 10 CFR 73.37, Requirements for physical protection of irradiated reactor fuel in transit, or 10 CFR 73.35, Requirements for physical protection of irradiated reactor fuel (100 grams or less), depending on the quantity of spent fuel being transported.

Alternative 1: No-Action Alternative Under the no-action alternative, the NRC will not delete the requirements in 10 CFR 71.97. NRC licensees will be required by both 10 CFR 71.97, and either 10 CFR 73.35 or 10 CFR 73.37, to submit advance notification of shipments of spent fuel. It is possible that a shipment could meet the advance notification requirements of 10 CFR 71.97 and 10 CFR 73.37 or 10 CFR 73.35, thus presenting the licensee with a requirement to provide two similar reports to the same agencies (State and Federal agencies) to describe a single shipment.

Alternative 2: Revise 10 CFR Part 71 The NRC will revise 10 CFR 71.97 to remove the requirement for advance notification of shipment of irradiated reactor fuel but will not change the requirements for advance notification of nuclear waste, thus deleting the duplicative reporting requirements for irradiated reactor fuel.

3.4 Impacted Regulatory Guidance Documents If this rule is implemented, the staff will update RG 7.9 to include conforming changes.

4 Estimates of Costs and Savings This section provides estimates of the costs and savings associated with the alternatives described in the previous section.

4.1 Basis for Cost and Savings Estimates The costs were determined based on estimates of normal costs (real costs) and potential savings (averted costs). Averted costs are costs of activities and actions performed under the existing regulations that will no longer be required if a revision to 10 CFR Part 71 is implemented. Averted costs are considered benefits (savings) and are assigned positive values.

Normal costs are real costs of new or additional actions (i.e., if Alternative 2 is implemented in whole or in part) and are assigned negative values (in parentheses). The net present value (NPV) is the discounted normal and averted cost estimates in 2020 dollars.

The following summarizes the implementation and operational costs to industry (licensees and CoC holders), the NRC, and the Agreement States.

20 Industry Implementation. This attribute accounts for the projected net economic effect on the affected licensees to implement the mandated changes. Costs include procedural and administrative activities related to establishing plans and revising procedures. Additional costs above the regulatory baseline are considered negative, and cost savings and averted costs are considered positive.

Industry Operation. This attribute accounts for the projected net economic effect caused by routine and recurring activities required by the guidance or regulation changes. Activities currently performed but which will no longer be required if the alternative is implemented are treated as averted costs.

NRC Implementation. This attribute accounts for the projected net economic effect on the NRC if the rule is implemented. It includes NRC implementation costs and potential savings relative to those expected under the regulatory baseline.

NRC Operation. This attribute accounts for the projected net economic effect on the NRC after the rule is developed and implemented.

Agreement State Implementation. This attribute accounts for the projected net economic effect on the Agreement States to implement all of the mandated changes to 10 CFR Part 71. Costs include procedural and administrative activities related to harmonizing State regulations with NRC policy and other guidance documents. The NRC regulations or equivalent legally binding requirements should be adopted and implemented within a 3-year timeframe from the effective date of the NRCs final rule as stated in the Federal Register notice. The Agreement State implementation costs were estimated based on the following considerations:

The number of Agreement States is 39.

On average, 756 productive hours will be required to update State regulations. This average includes Agreement States that are promulgating the minimum number of requirements and those promulgating the maximum (i.e., those Agreement States with licensees that ship using one of the general licenses (in 10 CFR 71.17, General license:

NRC-approved package, or 10 CFR 71.21-10 CFR 71.23) other than industrial radiography).

The average hourly rate range for a state employee is $101 per hour (a range of $32 to

$161).

The NRC regulations or equivalent legally binding requirements will be adopted and implemented within 3 years of the effective date of the NRCs final rule.

Agreement State Operation. The NRC determined that the Agreement States will incur operational costs as a result of the rule, as shown in section 4.2.15.4.

4.2 Evaluation of Alternative 2 - Revise 10 CFR Part 71 The tables beginning in section 4.2.1 give tabulated cost estimates for the NRC, industry, and Agreement States by respective issue. For estimating purposes, the three input values were used in the Monte Carlo sensitivity analysis and yielded the results shown. The sections below describe how the costs were developed for each issue.

21 4.2.1 Revision of Fissile Exemptions 4.2.1.1 Add Fissile Exemption for Packages Containing 3.5 Grams 235U per Package This change will present a new option under the fissile exemption provisions in 10 CFR 71.15.

Consignors that wish to ship more than 2.0 grams of up to 5.0 weight percent enriched uranium, but less than 3.5 grams of 235U enriched up to 5.0 weight percent, currently either have to break this material into two shipments of 2.0 grams or less of 235U (10 CFR 71.15(a)) or ship in a package such that there is at least 200 grams nonfissile material per gram of fissile material (700 grams nonfissile material; 10 CFR 71.15(b)). Any of these shipments will have to be in a Type A package (exempt quantity of 235U is less than 0.123 grams), and there is no associated consignment or other accumulation limit.

The averted cost for this change will be from a decreased number of shipments compared to the 2.0-gram provision in 10 CFR 71.15(a). The affected licensees consist primarily of enrichment and fuel fabrication facilities, and other facilities undergoing decommissioning.

Currently, the NRC anticipates that six uranium fuel fabrication plant licensees and five enrichment plant licensees will make shipments under this provision. Each affected licensee will be expected to make a low number of shipments under this provision, from several to dozens per year. This provision could also affect several U.S. Department of Energy (DOE) facilities, but these effects are not being considered for this impact assessment.

For cost analysis considerations, the staff estimates an average of 20 averted shipments per year, per licensee, over the 11-year period considered for the cost analysis. Each shipment is estimated to have an average averted cost of $1,083, as shown in table 1.

22 Table 1 Estimated Averted Cost of Making Shipments with New Fissile Exemption Year Description Number of Affected Fissile Material Licensees Number of Shipments per Year Cost per Shipment Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$347,581

$420,522 2026 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$324,842

$408,274 2027 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$303,590

$396,382 2028 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$283,729

$384,837 2029 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$265,168

$373,628 2030 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$247,820

$362,746 2031 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$231,608

$352,180 2032 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$216,456

$341,923 2033 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$202,295

$331,964 2034 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$189,061

$322,295 2035 Averted cost to ship under this exemption 20 23

$1,083

$487,500

$176,692

$312,908 Total Benefit (Cost)

$5,362,500

$2,788,843

$4,007,658 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.1.2 Up to 140 Grams Fissile Nuclides, Shipped Exclusive Use This change will provide a new option under the fissile exemption provisions in 10 CFR 71.15.

Licensees that wish to ship up to 140 grams of fissile material currently either have to break this material into as many as 10 packages, each containing 14 grams of fissile material and at least 200 grams nonfissile material per gram of fissile material in order to ship under the general licenses in 10 CFR 71.22 or 10 CFR 71.23, or transport all 140 grams in an NRC-certified Type AF or a B(U)F/B(M)F package. This new option will affect primarily 235U shipments, as small quantities of 233U or plutonium require shipment in a Type B package.

However, there could still be averted costs from new or amended Type B package certificates, including up to 140 grams fissile material as allowable contents, as the applicant will not have to perform, and the NRC will not have to evaluate, a criticality safety evaluation in accordance with 10 CFR 71.55 and 10 CFR 71.59.

For 233U and plutonium shipments, 140 grams of fissile material will still have to be in an NRC-certified Type B package, although it could be in one that did not have an approved criticality safety analysis (i.e., did not have an F certification). The staff estimates that the cost savings will be small for such a small quantity of fissile material, for which subcriticality will be easy to demonstrate in a certificate application. The averted cost in this case will be from not having to demonstrate criticality safety for a new or previously certified Type B(U) or B(M) package (without the F fissile certification). Because this is a specialized type of shipment, the staff estimates that one applicant might design a new package or modify an existing package to take advantage of this rule change over the 11-year period considered for the cost analysis.

For this design, the applicant could simply refer to the mass limit in this exemption, and limit such shipments to exclusive use, rather than providing a demonstration of criticality safety in

23 accordance with 10 CFR 71.55 and 10 CFR 71.59. The staff estimates that a demonstration of criticality safety to support certification of this amount of material will take 87 hours0.00101 days 0.0242 hours 1.438492e-4 weeks 3.31035e-5 months on average, at an average averted cost of $203 per hour, as shown in table 2.

Table 2 Averted Cost to Licensees Using New 140 Gram Fissile Exemption Year Description No. of Exemptions No. of Hours Hourly Cost Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$1,142

$1,382 2026 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$1,067

$1,342 2027 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$998

$1,303 2028 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$932

$1,265 2029 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$871

$1,228 2030 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$814

$1,192 2031 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$761

$1,157 2032 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$711

$1,124 2033 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$665

$1,091 2034 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$621

$1,059 2035 Averted cost to prepare and submit an application 0.09 87

$203

$1,602

$581

$1,028 Total 1.00

$17,622

$9,165

$13,170 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The NRC modeled this as a one-time action over the 11-year cycle. The staff estimates that NRC review of an applicants criticality safety demonstration will take approximately 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months on average, at an average averted cost of $131 per hour, as shown in table 3.

Table 3 Averted NRC Review Cost for 140 Gram Fissile Exemption Year Description No. of NRC Review of Exemptions per Year Hours to Review Exemptions Hourly Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC operational averted costs 0.09 43

$131

$508

$362

$438 2026 NRC operational averted costs 0.09 43

$131

$508

$339

$426 2027 NRC operational averted costs 0.09 43

$131

$508

$316

$413 2028 NRC operational averted costs 0.09 43

$131

$508

$296

$401 2029 NRC operational averted costs 0.09 43

$131

$508

$276

$389 2030 NRC operational averted costs 0.09 43

$131

$508

$258

$378 2031 NRC operational averted costs 0.09 43

$131

$508

$241

$367 2032 NRC operational averted costs 0.09 43

$131

$508

$226

$356 2033 NRC operational averted costs 0.09 43

$131

$508

$211

$346

24 Year Description No. of NRC Review of Exemptions per Year Hours to Review Exemptions Hourly Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2034 NRC operational averted costs 0.09 43

$131

$508

$197

$336 2035 NRC operational averted costs 0.09 43

$131

$508

$184

$326 Total 1.00

$5,589

$2,907

$4,177 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The affected licensees consist primarily of enrichment and fuel fabrication facilities and reactor facilities undergoing decommissioning. Currently, the NRC anticipates that 6 uranium fuel fabrication plant licensees, 5 enrichment plant licensees, and 18 reactor units undergoing decommissioning will make shipments under the 140-gram limitation. Under this proposal, each affected licensee will be expected to make a low number of shipments, from several to dozens per year. This provision could also affect several DOE facilities, but these effects are not being considered for this impact assessment because the DOE does not follow NRC regulations for shipments between its facilities. Under DOT regulations, the DOE self-certifies shipments between its facilities. For cost analysis considerations, the staff estimates an average of 11 shipments per year that will be made under this new provision, per licensee, over the 11-year period considered for the cost analysis. The staff estimates that the cost savings of shipping in a Type A or B package, as opposed to a Type AF or BF package, is an average of $108 per shipment, as shown in table 4.

Table 4 Licensee Shipping Benefit Using the 140 Gram Fissile Exemption Year Description Number of Licensees Number of Shipments Cost per Shipment Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$25,103

$30,371 2026 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$23,461

$29,486 2027 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$21,926

$28,628 2028 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$20,492

$27,794 2029 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$19,151

$26,984 2030 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$17,898

$26,198 2031 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$16,727

$25,435 2032 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$15,633

$24,694 2033 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$14,610

$23,975 2034 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$13,654

$23,277 2035 Licensee averted shipping cost under this exemption 30 11

$108

$35,208

$12,761

$22,599 Total 121

$387,292

$201,416

$289,442 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

25 4.2.2 Revision of Reduced External Pressure Test for Normal Conditions of Transport The NRC has decided not to pursue any changes to the reduced external pressure test requirement under 10 CFR Part 71.71(c)(3).

4.2.3 Type C Package Standards The NRC has decided not to pursue any changes to Type C package standards in this rulemaking.

4.2.4 Revision of Insolation Requirements for Package Evaluations 4.2.4.1 Cost Impacts of Insolation for Normal Conditions of Transport Cost Impact to Existing Certificate Holders The staff estimates that all holders of the 14 certificates that do not have an -85 or -96 in the package identification number will request a revision for their certificates to show they meet the revised NRC requirements in the first 9 years after the rule change to ensure the packages are approved within the 15-year timeframe for package phaseout. In addition, the staff estimates that certificate holders will revise an additional four CoCs that contain either a -85 or -96 in the package identification number to show they meet revised NRC requirements. Therefore, the NRC estimates that certificate holders will revise an average of 7.5 certificates per year over a 11-year period (14 certificates that will be phased out in the first 9 years of the rulemaking and another 4 certificate revisions for those with a -85 and-96 every year after the rulemaking is effective) following the rulemaking effective date to show compliance with the revised NRC requirements.

The costs to evaluate this change in insolation to current certificate holders will only be incurred if they were to request a revision of their CoC to show compliance with the revised NRC regulations. The cost to an existing certificate holder to evaluate the new insolation values will vary depending on the complexity of the thermal evaluation. Certificate holders may use reasoned arguments to evaluate the insolation increase of some smaller packages with significant margin, whereas for larger more complex packages (i.e., spent fuel and Type B waste packages), the certificate holders will likely revise their finite element thermal models. The staff estimates that the cost to evaluate the new insolation values and to submit an application including the result has a mean value of ($8,667) and will range from a low value of $2,000 to a high value of $20,000 per package, depending on the complexity of the package design, as shown in table 5.

Table 5 Cost for Certificate Holders to Prepare an Application Evaluating New Insolation Value Year Description No. of Certificate Revisions Certification Request Preparation Cost Net Benefit (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($35,994)

($43,547) 2026 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($33,639)

($42,279) 2027 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($31,438)

($41,048) 2028 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($29,382)

($39,852)

26 Year Description No. of Certificate Revisions Certification Request Preparation Cost Net Benefit (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2029 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($27,460)

($38,691) 2030 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($25,663)

($37,564) 2031 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($23,984)

($36,470) 2032 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($22,415)

($35,408) 2033 Cost to submit certificate for new insolation 5.8

$8,667

($50,483)

($20,949)

($34,377) 2034 Cost to submit certificate for new insolation 4.2

$8,667

($36,400)

($14,117)

($24,065) 2035 Cost to submit certificate for new insolation 4.2

$8,667

($36,400)

($13,193)

($23,364)

Total 58

($527,150)

($278,234)

($396,665) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The staff estimates that time required to review these applications will vary depending on the complexity of the package. The staff estimates that the time required to review an update to the value for insolation will range from a low of 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months to a maximum of 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , with the most likely review time of 15 hours1.736111e-4 days 0.00417 hours 2.480159e-5 weeks 5.7075e-6 months . Table 6 shows that the estimated review cost is ($62,000) using a 7 percent discount rate and ($89,000) using a 3 percent discount rate.

Table 6 NRC Cost to Review Applications for Revised CoCs Year Description Number of Revised Certificates Number of Review Hours Labor Rate Net Benefit (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review costs 5.8 15

$131

($11,318)

($8,070)

($9,763) 2026 NRC review costs 5.8 15

$131

($11,318)

($7,542)

($9,479) 2027 NRC review costs 5.8 15

$131

($11,318)

($7,048)

($9,203) 2028 NRC review costs 5.8 15

$131

($11,318)

($6,587)

($8,935) 2029 NRC review costs 5.8 15

$131

($11,318)

($6,156)

($8,674) 2030 NRC review costs 5.8 15

$131

($11,318)

($5,754)

($8,422) 2031 NRC review costs 5.8 15

$131

($11,318)

($5,377)

($8,176) 2032 NRC review costs 5.8 15

$131

($11,318)

($5,025)

($7,938) 2033 NRC review costs 5.8 15

$131

($11,318)

($4,697)

($7,707) 2034 NRC review costs 4.2 15

$131

($8,161)

($3,165)

($5,395) 2035 NRC review costs 4.2 15

$131

($8,161)

($2,958)

($5,238)

Total

($118,185)

($62,379)

($88,930) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Impact to Applicants for a New Certificate of Compliance Applicants for a new CoC will have a small additional accrued cost because of this rulemaking.

Although applicants for a CoC are already required to evaluate insolation, increasing the value by approximately 3 percent will increase the cost to perform a review by a small margin. The staff estimates that for small packages where material properties have margin to their operating limits, the increased additional charge will be approximately $500. Larger, more complex packages (i.e., spent fuel and Type B waste packages) will require more complex computer modeling, so that the NRC review cost will be approximately $2,000. The staff estimates that one new package per year for the 11 years following the final rule effective date will be

27 submitted for review and approval. The staff estimates that the accrued cost for this review will be approximately $1,083 per package as shown in table 7.

Table 7 Licensee Accrued Costs for New CoCs Year Description Number of New Certificates Certification Request Preparation Cost Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Accrued cost for new CoC 1

$1,083

($1,083)

($772)

($934) 2026 Accrued cost for new CoC 1

$1,083

($1,083)

($722)

($907) 2027 Accrued cost for new CoC 1

$1,083

($1,083)

($675)

($881) 2028 Accrued cost for new CoC 1

$1,083

($1,083)

($631)

($855) 2029 Accrued cost for new CoC 1

$1,083

($1,083)

($589)

($830) 2030 Accrued cost for new CoC 1

$1,083

($1,083)

($551)

($806) 2031 Accrued cost for new CoC 1

$1,083

($1,083)

($515)

($783) 2032 Accrued cost for new CoC 1

$1,083

($1,083)

($481)

($760) 2033 Accrued cost for new CoC 1

$1,083

($1,083)

($450)

($738) 2034 Accrued cost for new CoC 1

$1,083

($1,083)

($420)

($716) 2035 Accrued cost for new CoC 1

$1,083

($1,083)

($393)

($695)

Total 11

($11,917)

($6,197)

($8,906) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The staff estimates that on average, the cost to the NRC to review and provide the safety evaluation for an application for a new certificate with the increased value for insolation will be approximately 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months for small packages, 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months for large, complex packages and, on average, approximately 5.5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months .

Table 8 NRC Incremental Costs to Review New CoCs Year Description No. of New Certificate Submittals No. of Review Hours Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($514)

($621) 2026 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($480)

($603) 2027 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($449)

($586) 2028 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($419)

($569) 2029 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($392)

($552) 2030 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($366)

($536) 2031 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($342)

($520) 2032 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($320)

($505) 2033 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($299)

($491) 2034 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($279)

($476) 2035 NRC costs to review submitted certificates 1.0 (5.5)

$131

($720)

($261)

($462)

Total 11.0

($7,925)

($4,121)

($5,923) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Table 8 estimates that the incremental NRC review costs are $4,100 using a 7 percent discount rate and $5,900 using a 3 percent discount rate.

28 4.2.4.2 Cost Impacts of Insolation for Hypothetical Accident Conditions Cost Impact to Existing Certificate Holders Similar to the cost for impacts of insolation for normal conditions of transport detailed above, the cost to an existing certificate holder to evaluate the insolation as an initial condition to the fire test will vary depending on the complexity of the thermal evaluation. Certificate holders for some smaller packages with significant margin may use reasoned argument to evaluate the revised initial condition, whereas certificate holders for larger, more complex packages (i.e., spent fuel and Type B waste packages) will likely revise their finite element thermal models.

The staff estimates that for smaller packages, the cost to a certificate holder to evaluate the new insolation condition and include the result in an application is approximately $1,000. Larger, more complex packages will cost approximately $50,000, depending on the number of analyses that have to be reevaluated. The staff estimates that the average cost to its certificate holders will be approximately $20,000, assuming more than one analysis must be reevaluated. The staff estimates that all 14 certificate holders will update their package designs to the revised regulations, from the package designs approved without a -85 or -96 in the package identification number. In addition, for the certificates approved with either a -85 or -96 in the package identification number, the staff estimates that certificate holders will want to revise an additional four certificates per year, over an 11-year period. Therefore, the staff estimates that certificate holders will update an average of 7.5 certificates per year over the 11-year period following the final rule effective date to show compliance with the revised NRC regulations.

The staff estimated that the average cost to prepare and submit an application to the NRC is

$21,833 for each application submitted for the next 11 years after the rule change, as shown in table 9. Since the NRC expects on average 5.8 applications each year for the first 9 years after the rule change and 4.2 applications for years 10 to 11, the undiscounted cost to certificate holders will total $1,149,471 for years 2025-2033 and $183,400 for years 2034-2035, for a total cost of $1,328,013.

Table 9 Certificate Holder Cost to Evaluate Insolation as an Initial Condition Year Description Number of Certificates Submitted Certification Request Preparation Cost Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Cost to evaluate insolation as an initial condition 5.8

$21,833

($127,179)

($90,677)

($109,706) 2026 Cost to evaluate insolation as an initial condition 5.8

$21,833

($127,179)

($84,745)

($106,511) 2027 Cost to evaluate insolation as an initial condition 5.8

$21,833

($127,179)

($79,201)

($103,408) 2028 Cost to evaluate insolation as an initial condition 5.8

$21,833

($127,179)

($74,019)

($100,396) 2029 Cost to evaluate insolation as subsequent condition 5.8

$21,833

($127,179)

($69,177)

($97,472) 2030 Cost to evaluate insolation as subsequent condition 5.8

$21,833

($127,179)

($64,651)

($94,633) 2031 Cost to evaluate insolation as subsequent condition 5.8

$21,833

($127,179)

($60,422)

($91,877) 2032 Cost to evaluate insolation as subsequent condition 5.8

$21,833

($127,179)

($56,469)

($89,201) 2033 Cost to evaluate insolation as subsequent condition 5.8

$21,833

($127,179)

($52,775)

($86,603) 2034 Cost to evaluate insolation as subsequent condition 4.2

$21,833

($91,700)

($35,563)

($60,625)

29 Year Description Number of Certificates Submitted Certification Request Preparation Cost Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2035 Cost to evaluate insolation as subsequent condition 4.2

$21,833

($91,700)

($33,236)

($58,859)

Total

($1,328,013)

($700,935)

($999,291) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The staff estimates that time required to review these applications will vary depending on the complexity of the package. The staff estimates that the time required to review an update to the value for insolation will range from a low of 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months to a maximum of 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , with the most likely review time of 15 hours1.736111e-4 days 0.00417 hours 2.480159e-5 weeks 5.7075e-6 months , as shown in table 10.

Table 10 NRC Cost to Review Applications for Revised CoCs Year Description No. of Certificates Submitted Hours to Review Applications Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review of revised certificates 5.8 15

$131

($11,318)

($8,070)

($9,763) 2026 NRC review of revised certificates 5.8 15

$131

($11,318)

($7,542)

($9,479) 2027 NRC review of revised certificates 5.8 15

$131

($11,318)

($7,048)

($9,203) 2028 NRC review of revised certificates 5.8 15

$131

($11,318)

($6,587)

($8,935) 2029 NRC review of revised certificates 5.8 15

$131

($11,318)

($6,156)

($8,674) 2030 NRC review of revised certificates 5.8 15

$131

($11,318)

($5,754)

($8,422) 2031 NRC review of revised certificates 5.8 15

$131

($11,318)

($5,377)

($8,176) 2032 NRC review of revised certificates 5.8 15

$131

($11,318)

($5,025)

($7,938) 2033 NRC review of revised certificates 5.8 15

$131

($11,318)

($4,697)

($7,707) 2034 NRC review of revised certificates 4.2 15

$131

($8,161)

($3,165)

($5,395) 2035 NRC review of revised certificates 4.2 15

$131

($8,161)

($2,958)

($5,238)

Total 58

($118,185)

($62,379)

($88,930) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Cost Impact to Applicants for a New Certificate of Compliance The staff estimates that there will be an additional accrued cost for new CoCs. Although not explicitly required, most applicants for a CoC already have included insolation as an initial condition to the fire test. Adding this as an initial condition in 10 CFR 71.73(c)(4) will increase the applicants cost to prepare and submit an application by a small margin. The staff estimates that for small packages where material properties have margin to their material temperature limits, the increased cost will be approximately $1,000 per package for an applicant to prepare and submit an application. Larger, more complex packages (i.e., spent fuel and Type B waste packages) will require more complex computer modeling, therefore the increased cost will be approximately $30,000 per package for an applicant to prepare and submit an application. The high estimate is for the package or two that have material properties that are very close to the upper limit for use. The staff estimates that the average cost for a certificate holder to evaluate the new solar insolation quantity will be approximately $6,500, as shown in table 11.

Table 11 Licensee Costs to Submit Certificate for New CoC

30 Year Description No. of Applications per Year Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($4,634)

($5,607) 2026 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($4,331)

($5,444) 2027 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($4,048)

($5,285) 2028 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($3,783)

($5,131) 2029 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($3,536)

($4,982) 2030 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($3,304)

($4,837) 2031 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($3,088)

($4,696) 2032 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($2,886)

($4,559) 2033 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($2,697)

($4,426) 2034 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($2,521)

($4,297) 2035 Licensee costs to prepare and submit revised certificates 1

$6,500

($6,500)

($2,356)

($4,172)

Total 11

($71,500)

($37,185)

($53,435) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The staff estimates that it will receive one new package per year over the 11-year period following the final rule effective date and that its review cost to evaluate these submittals will depend on the package type and how the applicant evaluated the package for the fire test. The staff estimates that smaller packages will take approximately 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months to perform the application review and to document the review in a safety evaluation report, while larger, more complex package design reviews will take approximately 30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months . The staff estimates that the average review time for this change will be 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months , as shown in table 12.

Table 12 NRC Incremental Costs to Review New CoCs Year Description No. of New Certificates No. of Hours to Review New Application NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC costs to review new CoC 1

12

$131

($1,594)

($1,136)

($1,375) 2026 NRC costs to review new CoC 1

12

$131

($1,594)

($1,062)

($1,335) 2027 NRC costs to review new CoC 1

12

$131

($1,594)

($993)

($1,296) 2028 NRC costs to review new CoC 1

12

$131

($1,594)

($928)

($1,258) 2029 NRC costs to review new CoC 1

12

$131

($1,594)

($867)

($1,222) 2030 NRC costs to review new CoC 1

12

$131

($1,594)

($810)

($1,186) 2031 NRC costs to review new CoC 1

12

$131

($1,594)

($757)

($1,151) 2032 NRC costs to review new CoC 1

12

$131

($1,594)

($708)

($1,118) 2033 NRC costs to review new CoC 1

12

$131

($1,594)

($661)

($1,085) 2034 NRC costs to review new CoC 1

12

$131

($1,594)

($618)

($1,054) 2035 NRC costs to review new CoC 1

12

$131

($1,594)

($578)

($1,023)

Total 11

($17,532)

($9,118)

($13,102) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

31 4.2.5 Inclusion of Definition for Radiation Level For cost analysis considerations, the staff estimates that no licensees will prepare revised applications or revise facility documentation. The staff estimates no costs to licensees or certificate holders for this issue.

4.2.6 Deletion of the Low Specific Activity-III Leaching Test The staff estimates there will be an averted cost impact of this change to licensees or CoC holders because removing the leaching test requirement will provide regulatory relief. The test will be removed from 10 CFR 71.77 and will no longer be required. Five licensees are expected to perform this test over the next 11 years if the test is not removed during this rulemaking. The NRC estimates that the mean averted cost for each test will be $21,667, as shown in table 13, with a minimum test cost of $10,000, a most likely cost of $20,000, and a maximum test cost of

$40,000. The total averted cost over the 11 years following the rulemaking is $59,676, using a 7 percent discount factor.

Table 13 Averted Cost for Deletion of Leaching Test Year Description No. of LSA-III Leaching Tests Cost for LSA-III Leaching Test Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$7,022

$8,495 2026 Licensee preparation to assess impact of deletion of LSA-III leaching test 0.45

$21,667

$9,848

$6,562

$8,248 2027 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$6,133

$8,008 2028 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$5,732

$7,774 2029 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$5,357

$7,548 2030 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$5,006

$7,328 2031 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$4,679

$7,115 2032 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$4,373

$6,908 2033 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$4,087

$6,706 2034 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$3,819

$6,511 2035 Licensee preparation to assess impact of deletion of the LSA-III leaching test 0.45

$21,667

$9,848

$3,570

$6,321 Total Benefit (Cost)

$118,182

$59,676

$87,100 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

32 4.2.7 Inclusion of New Definition for Surface Contaminated Object The staff estimates there will be no costs to CoC holders with the addition of the SCO-III definition to the regulations, as the new SCO-III material will not be packaged in Type B packages. Therefore, when licensees apply the SCO-III definition, the staff estimates that licensees will benefit because they will not have to get a Type B package approved in accordance with 10 CFR 71.41(d). The NRC estimates that licensees costs to prepare an application for an approval under 10 CFR 71.41(d) range from $25,000 for smaller packages to

$75,000 for much larger or more complex packages, with an average cost of $50,000. To date, the NRC has approved one package authorization under the provisions of 10 CFR 71.41(d),

which required 400 hours0.00463 days 0.111 hours 6.613757e-4 weeks 1.522e-4 months . The NRC estimates that the time required to review these packages could range from 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months to 600 hours0.00694 days 0.167 hours 9.920635e-4 weeks 2.283e-4 months . There are 18 nuclear power plants in the active process of decommissioning that may use the new SCO-III provisions the first 11 years after issuance of the rulemaking. As shown in table 14, the averted cost to apply the SCO-III definition for the 18 plants over the 11 years following the rulemaking is $468,057, using a 7 percent discount rate.

Table 14 Averted Cost for Licensees Using SCO-III Package Year Description No. of Licensees that Apply the New Definition Cost to Prepare Application Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 202 5

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$58,335

$70,577 202 6

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$54,519

$68,521 202 7

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$50,952

$66,526 202 8

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$47,619

$64,588 202 9

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$44,504

$62,707 203 0

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$41,592

$60,880 203 1

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$38,871

$59,107 203 2

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$36,328

$57,386 203 3

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$33,952

$55,714 203 4

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$31,731

$54,091 203 5

Licensee assessment of material to qualify as SCO-III 1.6

$50,000

$81,818

$29,655

$52,516 Total Benefit (Cost)

$900,000

$468,057

$672,614 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

33 Table 15 shows the averted cost to the NRC for the 11 years as $490,000, based on a 7 percent discount rate.

Table 15 Averted Cost for NRC Review for Licensees Using SCO-III Year Description No. of Decommissioned Power Plants that Apply New Definition No. of Hours to Review and Issue an Exemption Request NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$61,131

$73,959 2026 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$57,132

$71,805 2027 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$53,394

$69,714 2028 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$49,901

$67,683 2029 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$46,637

$65,712 2030 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$43,586

$63,798 2031 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$40,734

$61,940 2032 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$38,069

$60,136 2033 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$35,579

$58,384 2034 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$33,251

$56,684 2035 NRC harmonized with DOT regulation 1.6 400

$131

$85,739

$31,076

$55,033 Total Benefit (Cost)

$943,132

$490,489

$704,849 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.8 Revision of Uranium Hexafluoride Package Requirements Currently the NRC has two CoCs to transport UF6 in 30B cylinders, one of which has already shown that the plug meets the requirements in SSR-6, 2018 Edition. If a certificate holder desires to revise the CoC to the new NRC requirements harmonized with SSR-6, 2018 Edition, then it will have to demonstrate that the cylinder plug remains leak tight after the tests for hypothetical accident conditions listed in 10 CFR 71.73 and does not contact any other part of the package other than at its point of attachment to the cylinder. The NRC estimates the cost to existing certificate holders to evaluate the change will depend on the information currently available to them. The NRC estimates that if existing drop tests or analyses could be used to demonstrate compliance with the final regulations, the cost to compile and submit an application to the NRC will be $50,000. However, if an applicant cannot use existing data and will need to perform calculations to provide a demonstration of the plug performance, then the NRC estimates the cost to the applicant to be approximately $100,000. If, instead of additional calculations, the certificate holder performed additional drop tests to demonstrate performance of the cylinder plug, then the cost estimate is $200,000, resulting in a mean cost of ($108,333),

as shown in table 16. This cost will be a single, onetime cost to the current certificate holder; however, it is unclear to the NRC in which year to include this onetime cost. Therefore, the NRC has averaged the cost over each of the 11 years following the rulemaking.

34 Table 16 Cost to Prepare Application for Revised UF6 CoC Year Description No. of Certificates Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($7,022)

($8,495) 2026 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($6,562)

($8,248) 2027 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($6,133)

($8,008) 2028 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($5,732)

($7,774) 2029 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($5,357)

($7,548) 2030 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($5,006)

($7,328) 2031 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($4,679)

($7,115) 2032 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($4,373)

($6,908) 2033 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($4,087)

($6,706) 2034 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($3,819)

($6,511) 2035 Number of certificates to be revised to current (2018) IAEA standards 0.09

($108,333)

($9,848)

($3,570)

($6,321)

Total 1.00

($108,333)

($56,340)

($80,963) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The NRC estimates that the cost to the NRC to perform the review will depend on the evaluation the certificate holder chooses to submit. The NRC estimates that if the applicant submits existing data and did not need to perform additional calculations or drop tests, it will take approximately 158 hours0.00183 days 0.0439 hours 2.612434e-4 weeks 6.0119e-5 months to review the one certificate the staff expects to be submitted within the 11-year period analysis period, as shown in table 17.

35 Table 17 NRC Cost to Review Application for Certificate Revision Year Description No. of Certificates Revised to 2018 IAEA Standards No. of Hours to Review Application NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review of revised certificates 0.09 158

$131

($1,886)

($1,345)

($1,627) 2026 NRC review of revised certificates 0.09 158

$131

($1,886)

($1,257)

($1,580) 2027 NRC review of revised certificates 0.09 158

$131

($1,886)

($1,175)

($1,534) 2028 NRC review of revised certificates 0.09 158

$131

($1,886)

($1,098)

($1,489) 2029 NRC review of revised certificates 0.09 158

$131

($1,886)

($1,026)

($1,446) 2030 NRC review of revised certificates 0.09 158

$131

($1,886)

($959)

($1,404) 2031 NRC review of revised certificates 0.09 158

$131

($1,886)

($896)

($1,363) 2032 NRC review of revised certificates 0.09 158

$131

($1,886)

($838)

($1,323) 2033 NRC review of revised certificates 0.09 158

$131

($1,886)

($783)

($1,285) 2034 NRC review of revised certificates 0.09 158

$131

($1,886)

($732)

($1,247) 2035 NRC review of revised certificates 0.09 158

$131

($1,886)

($684)

($1,211)

Total 1.00

($20,751)

($10,792)

($15,508) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Cost Impact to an Applicant for a New Certificate of Compliance The NRC is not aware of any new packages for transport of UF6 enriched to a maximum of 5 weight percent 235U. However, presuming that a new package is evaluated by testing, then the NRC estimates that the cost for a new CoC will be approximately $10,000 to perform the additional drop tests on the plug end. If calculations were performed to evaluate the performance of the plug, the NRC estimates the cost to perform the calculations and document their results in an application will be $25,000.

The NRC estimates that its cost to review and document the soundness of the cylinder plug after the tests for hypothetical accident conditions will be 50 hours5.787037e-4 days 0.0139 hours 8.267196e-5 weeks 1.9025e-5 months for a cost of $6,550, if the applicant evaluated the plug by drop tests, and 250 hours0.00289 days 0.0694 hours 4.133598e-4 weeks 9.5125e-5 months of review time at a cost of $32,750, if the new package is evaluated by analysis.

4.2.9 Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program The changes to the packaging requirements to add evaluation of aging effects and a maintenance program will impact the applications for transport package design approval and NRC reviews of the applications. These changes ensure consistency with IAEA standards and are needed to ensure that certificate holders and applicants adequately evaluate aging effects and include suitable maintenance program criteria for managing applicable aging effects.

Consequently, changes to packages or costsfor the NRC, current or future certificate holders, and general licenseesare anticipated to be implemented starting in 2029, as shown in tables 18, 19, and 20, with some extending beyond the 2035 period of analysis to 2043.

36 Table 18 Certificate Holder Cost to Revise Certificates Year Description Number of Revised Certificates Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Number of new or amended certificates 0

$36,833

$0

$0 2026 Number of new or amended certificates 0

$36,833

$0

$0 2027 Number of new or amended certificates 0

$36,833

$0

$0 2028 Number of new or amended certificates 0

$36,833

$0

$0 2029 Number of new or amended certificates 19

$36,833

($699,833)

($380,663)

($536,364) 2030 Number of new or amended certificates 20

$36,833

($736,667)

($374,484)

($548,149) 2031 Number of new or amended certificates 12

$36,833

($442,000)

($209,991)

($319,310) 2032 Number of new or amended certificates 13

$36,833

($478,833)

($212,608)

($335,844) 2033 Number of new or amended certificates 13

$36,833

($478,833)

($198,699)

($326,062) 2034 Number of new or amended certificates 3

$36,833

($110,500)

($42,854)

($73,054) 2035 Number of new or amended certificates 1

$36,833

($36,833)

($13,350)

($23,642)

Total 81

($2,983,500)

($1,432,648)

($2,162,425) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Table 19 Licensee Cost to Maintain Casks Year Description Number of casks maintained Licensee maintenance cost per cask Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee maintenance costs 0

$2,260

$0

$0 2026 Licensee maintenance costs 0

$2,260

$0

$0 2027 Licensee maintenance costs 0

$2,260

$0

$0 2028 Licensee maintenance costs 0

$2,260

$0

$0 2029 Licensee maintenance costs 0

$2,260

$0

$0 2030 Licensee maintenance costs 111.5

$2,260

($252,000)

($128,104)

($187,512) 2031 Licensee maintenance costs 111.5

$2,260

($252,000)

($119,723)

($182,050) 2032 Licensee maintenance costs 111.5

$2,260

($252,000)

($111,891)

($176,748) 2033 Licensee maintenance costs 111.5

$2,260

($252,000)

($104,571)

($171,600) 2034 Licensee maintenance costs 111.5

$2,260

($252,000)

($97,730)

($166,602) 2035 Licensee maintenance costs 111.5

$2,260

($252,000)

($91,336)

($161,749)

Total 669

($1,512,000)

($653,356)

($1,046,260) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

37 Table 20 NRC Cost to Revise Certificates Year Description No. of Certificates Revised to 2018 IAEA Standards No. of Hours to Review Application NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review of number of new or amended certificates 0

25

$131

$0

$0 2026 NRC review of number of new or amended certificates 0

25

$131

$0

$0 2027 NRC review of number of new or amended certificates 0

25

$131

$0

$0 2028 NRC review of number of new or amended certificates 0

25

$131

$0

$0 2029 NRC review of number of new or amended certificates 19 25

$131

($223,994)

($121,838)

($171,673) 2030 NRC review of number of new or amended certificates 20 25

$131

($235,783)

($119,860)

($175,445) 2031 NRC review of number of new or amended certificates 12 25

$131

($141,470)

($67,211)

($102,201) 2032 NRC review of number of new or amended certificates 13 25

$131

($153,259)

($68,049)

($107,493) 2033 NRC review of number of new or amended certificates 13 25

$131

($153,259)

($63,597)

($104,362) 2034 NRC review of number of new or amended certificates 3

25

$131

($35,367)

($13,716)

($23,382) 2035 NRC review of number of new or amended certificates 1

25

$131

($11,789)

($4,273)

($7,567)

Total 81

($954,922)

($458,544)

($692,122) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.10 Revision of Transitional Arrangements After the effective date of the final rule, this change will result in implementation costs to industry, but the magnitude of the costs depends upon the type of package and the required actions. For example, some previously approved package designs may already meet current safety regulations but lack the documentation for the NRC to make this determination. These packages will have fewer costs to recertify than packages that cannot be shown to meet current safety regulations. In general, the types of costs industry will bear include costs to (1) develop applications to show previously approved package designs meet the revised regulations, (2) develop new package design(s) or package modification(s), (3) analyze or physically test (or both) these new package design(s) or modification(s), (4) generate and submit revised package applications, and (5) implement these new design(s) or package modification(s). The NRC costs are to review and approve the new package designs or package modifications.

The staff reviewed the changes to the NRC regulations starting with the rule change effective on April 1, 1996 (60 FR 50248; September 28, 1995) [29], and the NRC-approved packages with certificates based on the NRC regulations harmonized with SSR No. 6, 1973 Edition, in the final rule effective on September 6, 1983 (48 FR 35600; August 5, 1983) [30]. Based on this review, the staff estimates that the cost to develop and provide an application to the NRC to update a certificate to the NRC regulations harmonized with SSR-6, 2018 Edition, will range from a low estimate of approximately $10,000, to a most likely estimate of $20,000, to a high estimate of

$30,000. This estimate excludes the costs for other changes that the certificate holder may voluntarily make to the package as a result of this rule change. The NRC estimates that the

38 average cost will be approximately $20,000 per package, excluding the costs estimated for other changes incorporated due to this rule change.

The NRC estimates that all certificate holders will revise the 14 certificates that were approved to the NRC regulations in effect before April 1, 1996 (i.e., packages that do not have a -85 or

-96 in their package identification number). The NRC estimates that, for packages with a -85 or -96 in the package identification number, certificate holders will revise an additional four certificates per year to the IAEA standards in SSR-6, 2018 Edition. Therefore, certificate holders will revise an average of 5.8 certificates per year for the first 9 years and 4.2 certificates per year for the next 2 years following the final rule effective date to show compliance with the NRC regulations in effect at the time, as shown in tables 21 and 22.

Table 20 Certificate Holder Cost to Revise Certificates Year Description Number of Revised Certificates Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($83,063)

($100,494) 2026 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($77,629)

($97,567) 2027 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($72,550)

($94,725) 2028 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($67,804)

($91,966) 2029 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($63,368)

($89,288) 2030 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($59,223)

($86,687) 2031 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($55,348)

($84,162) 2032 Licensee preparation of revised certificates 5.8

($20,000)

($116,500)

($51,727)

($81,711) 2033 Licensee preparation of revised certificates 4.2

($20,000)

($84,000)

($34,857)

($57,200) 2034 Licensee preparation of revised certificates 4.2

($20,000)

($84,000)

($32,577)

($55,534) 2035 Licensee preparation of revised certificates 4.2

($20,000)

($84,000)

($30,445)

($53,916)

Total 58.0

($1,184,000)

($628,592)

($893,250) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Table 21 NRC Review Time for Revised Certificates Cost Year Description No. of Certificates Revised to 2018 IAEA Standards No. of Hours to Review Licensee Report NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review certificate revision cost 5.8 130

$131

($99,193)

($70,723)

($85,564) 2026 NRC review certificate revision cost 5.8 130

$131

($99,193)

($66,096)

($83,072) 2027 NRC review certificate revision cost 5.8 130

$131

($99,193)

($61,772)

($80,653) 2028 NRC review certificate revision cost 5.8 130

$131

($99,193)

($57,731)

($78,304) 2029 NRC review certificate revision cost 5.8 130

$131

($99,193)

($53,954)

($76,023) 2030 NRC review certificate revision cost 5.8 130

$131

($99,193)

($50,425)

($73,809) 2031 NRC review certificate revision cost 5.8 130

$131

($99,193)

($47,126)

($71,659) 2032 NRC review certificate revision cost 5.8 130

$131

($99,193)

($44,043)

($69,572)

39 Year Description No. of Certificates Revised to 2018 IAEA Standards No. of Hours to Review Licensee Report NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2033 NRC review certificate revision cost 5.8 130

$131

($99,193)

($41,161)

($67,545) 2034 NRC review certificate revision cost 4.2 130

$131

($71,521)

($27,737)

($47,284) 2035 NRC review certificate revision cost 4.2 130

$131

($71,521)

($25,922)

($45,907)

Total

($1,035,775)

($546,690)

($779,391) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

For package designs that do not have a -85 or -96 in their package identification number and cannot be shown to meet current safety standards, the staff estimated the cost to design, receive NRC certification, and fabricate a replacement package. This estimate is based on updating the similar information in Section 3.3.8, Grandfathering of Previously Approved Packages, of NUREG/CR-6713, Regulatory Analysis of Major Revision of 10 CFR Part 71:

Final Rule, issued 2004, [31]. The staffs estimates for the cost to design, obtain NRC approval, and fabricate new packages range between $385,000 and $900,000, with an average cost of

$597,500, as shown in table 23.

Table 22 Certificate Holder Cost to Prepare an Application for a Replacement Package Year Description No. of Certificates Revised to 2018 IAEA Standards Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee cost to prepare an application 0.2

($597,500)

($119,500)

($85,202)

($103,082) 2026 Licensee cost to prepare an application 0.2

($597,500)

($119,500)

($79,628)

($100,079) 2027 Licensee cost to prepare an application 0.2

($597,500)

($119,500)

($74,419)

($97,164) 2028 Licensee cost to prepare an application 0.2

($597,500)

($119,500)

($69,550)

($94,334) 2029 Licensee cost to prepare an application 0.2

($597,500)

($119,500)

($65,000)

($91,587) 2030 Licensee cost to prepare an application 0

($0)

($0) 2031 Licensee cost to prepare an application 0

($0)

($0) 2032 Licensee cost to prepare an application 0

($0)

($0) 2033 Licensee cost to prepare an application 0

($0)

($0) 2034 Licensee cost to prepare an application 0

($0)

($0) 2035 Licensee cost to prepare an application 0

($0)

Total 1.0

($597,500)

($373,798)

($486,247) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The NRC estimates that the agencys review of these new package design applications will take a mean of 1,056 hours6.481481e-4 days 0.0156 hours 9.259259e-5 weeks 2.1308e-5 months per certificate, as shown in table 24. In addition, one package over a 3-year period (2027-2029), at $131 per staff hour, excluding any review time for costs associated with other changes in this rulemaking, results in a cost of ($65,821) at a 7 percent discount rate.

40 Table 23 NRC Review Cost for Reviewing an Application for a Replacement Package Year Description No. of Certificates Revisions to 2018 IAEA Standards No. of Hours to Review Licensee Reports NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2026 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2027 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2028 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2029 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2030 NRC cost to review new package design 0.3 1,056

$131

($46,111)

($23,441)

($34,311) 2031 NRC cost to review new package design 0.3 1,056

$131

($46,111)

($21,907)

($33,312) 2032 NRC cost to review new package design 0.3 1,056

$131

($46,111)

($20,474)

($32,341) 2033 NRC cost to review new package design 0

1,056

$131

($0)

($)

2034 NRC cost to review new package design 0

1,056

$131

($0)

($0) 2035 NRC cost to review new package design 0

1,056

$131

($0)

($)

Total 1.0 Total

($138,333)

($65,821)

($99,964) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.11 Inclusion of Head Space for Liquid Expansion The NRC currently has six CoCs that authorize liquid contents. The NRC estimates that, when an existing certificate holder desires to revise the certificate to the latest version of the regulations, the holder will have to review its application to ensure that it adequately addresses expansion of liquid due to thermal variations that may occur during normal conditions of transport and hypothetical accident conditions. The NRC estimates that this review will cost the applicant approximately $1,500 per application, as shown in table 25.

Table 24 Licensee Cost to Prepare and Evaluate Liquid Expansion Year Description No. of Certificates Revised to 2018 IAEA Standards Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee preparation of revised certificates 0.55

$1,500

($818)

($583)

($706) 2026 Licensee preparation of revised certificates 0.55

$1,500

($818)

($545)

($685) 2027 Licensee preparation of revised certificates 0.55

$1,500

($818)

($510)

($665) 2028 Licensee preparation of revised certificates 0.55

$1,500

($818)

($476)

($646) 2029 Licensee preparation of revised certificates 0.55

$1,500

($818)

($445)

($627) 2030 Licensee preparation of revised certificates 0.55

$1,500

($818)

($416)

($609) 2031 Licensee preparation of revised certificates 0.55

$1,500

($818)

($389)

($591)

41 Year Description No. of Certificates Revised to 2018 IAEA Standards Cost to Prepare and Submit Certification Request Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2032 Licensee preparation of revised certificates 0.55

$1,500

($818)

($363)

($574) 2033 Licensee preparation of revised certificates 0.55

$1,500

($818)

($340)

($557) 2034 Licensee preparation of revised certificates 0.55

$1,500

($818)

($317)

($541) 2035 Licensee preparation of revised certificates 0.55

$1,500

($818)

($297)

($525)

Total 6.00

($9,000)

($4,681)

($6,726) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The NRC estimates that there will be no additional cost to applicants for a new CoC because the NRC regulations in 10 CFR 71.87 already include an operational requirement to ensure that containers include sufficient head space for liquid contents.

The NRC estimates that its review of an application for revision of an existing certificate will take approximately 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months , as shown in table 26. The NRC estimates that the cost to evaluate six package applications to revise an existing CoC to meet NRC regulations that are harmonized with SSR-6, 2018 Edition, over an 11-year period will be $1,635, based on a 7 percent discount rate.

Table 25 NRC Cost to Evaluate Application for Liquid Expansion Year Description No. of Certificates Revisions to 2018 IAEA Standards for Liquid Expansion NRC Time to Perform the Review of Licensee Application (Hours) for Liquid Expansion NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review of revised certificates 1

4

$131

($286)

($204)

($247) 2026 NRC review of revised certificates 1

4

$131

($286)

($190)

($239) 2027 NRC review of revised certificates 1

4

$131

($286)

($178)

($232) 2028 NRC review of revised certificates 1

4

$131

($286)

($166)

($226) 2029 NRC review of revised certificates 1

4

$131

($286)

($155)

($219) 2030 NRC review of revised certificates 1

4

$131

($286)

($145)

($213) 2031 NRC review of revised certificates 1

4

$131

($286)

($136)

($206) 2032 NRC review of revised certificates 1

4

$131

($286)

($127)

($200) 2033 NRC review of revised certificates 1

4

$131

($286)

($119)

($195) 2034 NRC review of revised certificates 1

4

$131

($286)

($111)

($189)

Total 11

($3,144)

($1,635)

($2,349) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.12 Revision of Quality Assurance Program Biennial Reporting Requirements This rulemaking alternative will currently affect 41 QAP approval holders under 10 CFR Part 71, as shown in table 27. Each affected QAP approval holder will need to reconcile the change with its own procedures and processes, which will be a one-time implementation cost once the final

42 rule is issued. The NRC estimates that this review and update will cost, on average, $800 per QAP approval holder. The majority of QAP approval holders will not have to make any changes to their current processes because 38 of the 41 current QAP holders have already submitted biennial reports. Therefore, they will only incur the costs of performing the verification of their current processes. The NRC assumes the remaining three QAP approval holders did not send in a biennial report because no changes have been made to their QAP. They will need to make conforming changes to their current processes to ensure that they issue a biennial report to the NRC at future reporting intervals if they make no changes to their QAP during the previous 24 months.

Table 26 Licensee Cost to Evaluate Program Change for Biennial Reports Year Description No. of QAPs Clarified No. of Hours to Revise QAP Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee/certificate holder cost to evaluate QAP 41 10

$80

($32,800)

($23,386)

($28,294) 2026 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2027 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2028 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2029 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2030 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2031 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2032 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2033 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2034 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 2035 Licensee/certificate holder cost to evaluate QAP 0

10

$80

$0

$0 Total

($32,800)

($23,386)

($28,294) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

In addition, the three QAP approval holders discussed above that have not submitted a biennial report will incur the operational costs of issuing those biennial reports every 24 months stating no changes were made. The NRC estimates that QAP approval holder operational costs for issuance of its QAP biennial report every 24 months will be approximately 1 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months for each issuance occurrence at a rate of $80 per hour, as shown in table 28. The NRC assumes that an additional four QAP approval holders will need to submit a report in each future 24-month reporting interval if no changes were made to their QAPs.

Table 27 Licensee Cost to Submit Biennial Report Year Description No. of QAP Biennial Reports Submitted No. of Hours to Develop and Submit Biennial Report Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($219)

($264)

43 Year Description No. of QAP Biennial Reports Submitted No. of Hours to Develop and Submit Biennial Report Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2026 Licensees and certificate holders cost to submit QAP biennial report 0

1

$80

$0

$0 2027 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($191)

($249) 2028 Licensees and certificate holders cost to submit QAP biennial report 0

1

$80

$0

$0 2029 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($167)

($235) 2030 Licensees and certificate holders cost to submit QAP biennial report 0

1

$80

$0

$0 2031 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($146)

($221) 2032 Licensees and certificate holders cost to submit QAP biennial report 0

1

$80

$0

$0 2033 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($127)

($209) 2034 Licensees and certificate holders cost to submit QAP biennial report 0

1

$80

$0

$0 2035 Licensees and certificate holders cost to submit QAP biennial report 4

1

$80

($307)

($111)

($197)

Total 24

($1,839)

($960)

($1,376) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

The NRC estimates that its review of additional QAP biennial reports every 2 years will take approximately 1 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months each for every review occurrence at a rate of $131 per staff hour, as shown in table 29. The NRC assumed four additional QAP biennial reports will be reviewed based on three QAP approval holders who have not submitted a report as described above.

Table 28 NRC Cost to Review Biennial Report Year Description No. of Biennial Report Submittals No. of Hours to Review Biennial QAP Report NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review of biennial report submittals 4

1

$131

($502)

($358)

($433) 2026 NRC review of biennial report submittals 0

1

$131

$0

$0 2027 NRC review of biennial report submittals 4

1

$131

($502)

($313)

($408) 2028 NRC review of biennial report submittals 0

1

$131

$0

$0 2029 NRC review of biennial report submittals 4

1

$131

($502)

($273)

($385) 2030 NRC review of biennial report submittals 0

1

$131

$0

$0 2031 NRC review of biennial report submittals 4

1

$131

($502)

($238)

($363) 2032 NRC review of biennial report submittals 0

1

$131

$0

44 Year Description No. of Biennial Report Submittals No. of Hours to Review Biennial QAP Report NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2033 NRC review of biennial report submittals 4

1

$131

($502)

($208)

($342) 2034 NRC review of biennial report submittals 0

1

$131

$0

$0 2035 NRC review of biennial report submittals 4

1

$131

($502)

($182)

($322)

Total 24

($3,011)

($1,572)

($2,252) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.13 Deletion of Type A Package Limitations in Fissile Material General Licenses The staffs view is that a licensee that wished to ship up to 37 grams of plutonium previously will have done so in an NRC -certified Type B(U)F package, rather than splitting the material into a large number of shipments. The averted cost for this requirement, therefore, does not arise from having to demonstrate criticality safety for a new or previously certified Type B(U) package (without the F fissile certification). Because this is a specialized type of shipment, the staff estimates that two applicants might design a new package or modify an existing package to take advantage of this rule change. For this design, the applicant could simply refer to 10 CFR 71.22 for a CSI calculation and mass limits, rather than providing a demonstration of criticality safety in accordance with 10 CFR 71.55 and 10 CFR 71.59. The NRC estimates that a criticality safety assessment to support certification of this amount of material will take an average of 43 hours4.976852e-4 days 0.0119 hours 7.109788e-5 weeks 1.63615e-5 months , at an average cost of $203 per hour, as shown in table 30. The NRC estimates that the time needed to perform a typical criticality safety assessment review will take 43 hours4.976852e-4 days 0.0119 hours 7.109788e-5 weeks 1.63615e-5 months , on average, at an average cost of $131 per hour, as shown in table 31. The staff estimates that two certificates may be revised to take advantage of the new general license requirements, over the next 10 years.

Table 30 Averted Licensee Cost to Obtain Approval for Shipment in Type BF Package Year Description No. of Certificate Holders Adopting 10 CFR 71.22 Limit Certificate-Holder Labor Rate No. of Hours to Prepare Criticality Safety Evaluation Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$1,142

$1,382 2026 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$1,068

$1,342 2027 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$998

$1,303 2028 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$933

$1,265 2029 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$872

$1,228

45 Year Description No. of Certificate Holders Adopting 10 CFR 71.22 Limit Certificate-Holder Labor Rate No. of Hours to Prepare Criticality Safety Evaluation Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2030 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$815

$1,192 2031 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$761

$1,158 2032 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$711

$1,124 2033 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$665

$1,091 2034 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$621

$1,059 2035 Certificate holder averted cost by adopting 10 CFR 71.22 limit for plutonium 0.18

$203 43

$1,602

$581

$1,028 Total 2.00

$17,625

$9,166

$13,172 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

Table 29 Averted NRC Cost to Review Application for Approval for Shipment in Type BF Package Year Description No. of Certificate Holders Adopting 10 CFR 71.22 Limit No. of Hours to Review of Criticality Evaluation NRC Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 NRC review criticality evaluation 0.18 43

$131

$1,012

$722

$873 2026 NRC review criticality evaluation 0.18 43

$131

$1,012

$674

$848 2027 NRC review criticality evaluation 0.18 43

$131

$1,012

$630

$823 2028 NRC review criticality evaluation 0.18 43

$131

$1,012

$589

$799 2029 NRC review criticality evaluation 0.18 43

$131

$1,012

$551

$776 2030 NRC review criticality evaluation 0.18 43

$131

$1,012

$515

$753 2031 NRC review criticality evaluation 0.18 43

$131

$1,012

$481

$731 2032 NRC review criticality evaluation 0.18 43

$131

$1,012

$449

$710 2033 NRC review criticality evaluation 0.18 43

$131

$1,012

$420

$689 2034 NRC review criticality evaluation 0.18 43

$131

$1,012

$393

$669 2035 NRC review criticality evaluation 0.18 43

$131

$1,012

$367

$650 Total Benefit (Cost)

$11,134

$5,790

$8,321 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

46 There may also be averted costs associated with this change because licensees will be able to ship a Type B package, as opposed to a Type BF package. The NRC estimates that three affected shipments per year, on average, will be made under this revised provision, as shown in table 32. The staff estimates that the average averted cost per shipment of shipping in a Type B versus a Type BF package will be $233.

Table 30 Averted Licensee Cost to Make Shipment Using New Type B Package Limits Year Description No. of Shipments Incremental Cost of Shipping a Type B Versus a Type BF Package No. of Licensees Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$499

$604 2026 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$467

$587 2027 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$436

$569 2028 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$408

$553 2029 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$381

$537 2030 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$356

$521 2031 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$333

$506 2032 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$311

$491 2033 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$291

$477 2034 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$272

$463 2035 Averted licensee cost to ship under new Type B package limits 3

$233 1

$700

$254

$450 Total 33

$7,704

$4,007

$5,758 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.14 Deletion of 233U Restriction in Fissile General License For cost analysis considerations, the staff estimates an average of 11 averted shipments per year, per licensee, over the 11-year period considered for the cost analysis. The staff estimates an average cost of $1,850 per shipment, as shown in table 33. Costs are higher in this case than for Issue 1, as these packages require a fissile CSI label and associated accumulation restrictions.

47 Table 31 Licensee Averted Cost for Transporting Using General License in 10 CFR 71.22 Year Description No. of Fissile Material Licensees No. of Shipments of Low-Enriched 235U Cost per Shipment Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$162,003

$196,000 2026 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$151,405

$190,291 2027 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$141,500

$184,749 2028 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$132,243

$179,368 2029 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$123,592

$174,144 2030 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$115,506

$169,071 2031 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$107,950

$164,147 2032 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$100,887

$159,366 2033 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$94,287

$154,724 2034 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$88,119

$150,218 2035 Licensee averted shipment costs shipping under 10 CFR 71.22 11 11

$1,850

$227,218

$82,354

$145,843 Total) 121 121

$2,499,397

$1,299,846

$1,867,922 a

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.15 Other Recommended Changes to 10 CFR Part 71 4.2.15.1 Deletion of Duplicative Reporting Requirements Since the NRC is deleting duplicative requirements, instances in which licensees perform a shipment that is not in accordance with the regulations will still be reportable under 10 CFR 71.95(b), and there will be no change in costs.

4.2.15.2 Revision of the Definition of Low Specific Activity There is no cost impact expected from clarifying the definition of LSA. Revising the definition of LSA to make it consistent with the fissile exemptions in 10 CFR 71.15 to ensure licensees know that LSA packages may contain up to an exempt quantity of fissile material does not change the meaning of the definition.

4.2.15.3 Removal of Tables Containing A1 and A2 Values and Exempt Material Activity and Consignment Limits

48 There is no cost impact expected from revising Appendix A to 10 CFR Part 71. Removing Tables A-1 through A-4 and referencing the information with the values in the DOT regulations will remove duplicative information and the potential for errors, and will be consistent with SSR-6, 2018 Edition, since the DOT will revise its own tables with the seven radionuclide values. Since no packages are currently approved to transport Type B quantities of the seven new radionuclides, the NRC does not expect any new Type B package approvals.

4.2.15.4 Revision to Agreement State Compatibility Categories The NRC is revising the compatibility category designations for the reporting requirements in 10 CFR 71.95 and the regulations containing QAP review criteria for Agreement State review, approval, and inspection of the use of Type B packages, other than industrial radiography use, or the use of the general licenses in 10 CFR 71.21, 10 CFR 71.22, or 10 CFR 71.23, which also requires an approved QAP.

The NRC has not received any reports over the past several years of a significant reduction in the effectiveness of an NRC-approved Type B or Type AF packaging during use, or defects with safety significance in any NRC-approved Type B or fissile material packaging, after first use.

Therefore, the NRC does not expect to get any reports regarding Agreement State licensees pursuant to 10 CFR 71.95(a) over the next 11-year period. The NRC expects that each Agreement State that incorporates these changes will receive approximately two reports per year, pursuant to 10 CFR 71.95(b), for instances in which the CoC was not followed during shipment. The NRC estimates that licensees submitting these reports will take approximately 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months to complete the report and submit it to an Agreement State. The NRC estimates the amount of time needed to review a report ranges from a low of 1 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months , for reading and digesting the content of the report, to a high of 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months , to review the report and write a report summarizing the licensees report, with an average of approximately 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months , as shown in table 34. For the revised compatibility category designations to the QAP review criteria, the NRC does not expect any additional operational costs for Agreement States, as this is only a clarification of a previous change.

Table 32 Agreement States Costs to Review Reports Year Description No. of Agreement States No. of 10 CFR 71.95 Reports per Year No. of Hours to Review Reports Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2025 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($16,853)

($20,390) 2026 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($15,751)

($19,796) 2027 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($14,720)

($19,219) 2028 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($13,757)

($18,660) 2029 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($12,857)

($18,116)

49 Year Description No. of Agreement States No. of 10 CFR 71.95 Reports per Year No. of Hours to Review Reports Labor Rate Net Benefits (Cost) (2020 dollars)a,b Undiscounted 7% NPV 3% NPV 2030 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($12,016)

($17,589) 2031 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($11,230)

($17,076) 2032 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($10,495)

($16,579) 2033 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($9,809)

($16,096) 2034 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($9,167)

($15,627) 2035 Agreement State cost to review 10 CFR 71.95 reports 39 2

3

$101

($23,637)

($8,567)

($15,172)

Total 22

($260,012)

($135,223)

($194,320) a The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.

b There may be differences among tables due to rounding.

4.2.15.5 Deletion of Redundant Advance Notification Requirements for Shipment of Spent Fuel Revising 10 CFR 71.97 to remove the requirement for advance notification of a shipment of irradiated reactor fuel will not change the requirements for advance notification of nuclear waste.

Since reporting will still be required by either 10 CFR 73.35 or 10 CFR 73.37, there will be no increase or decrease in licensee costs for this rule clarification.

5 Uncertainty Analysis The NRC completed a Monte Carlo sensitivity analysis for this regulatory analysis using the specialty software @Risk.1 The Monte Carlo approach answers the question, What distribution of net benefits results from multiple draws of the probability distribution assigned to key variables?

5.1 Uncertainty Analysis Assumptions As this regulatory analysis uses estimates of values that are sensitive to unique certificate holders situations, the staff analyzed the variables that have the greatest amount of uncertainty.

To perform this analysis, the staff used a Monte Carlo simulation analysis using the

@Risksoftware program.

Monte Carlo simulations involve introducing uncertainty into the analysis by replacing the point estimates of the variables used to estimate base case costs and benefits with probability 1

Information about this software is available at https://www.palisade.lumiversocom.

50 distributions. By defining input variables as probability distributions instead of point estimates, the influence of uncertainty on the results of the analysis (in other words, the net benefits) can be effectively modeled.

The probability distributions chosen to represent the different variables in the analysis were bounded by the range-referenced input and the staffs professional judgment. When defining the probability distributions for use in a Monte Carlo simulation, summary statistics are used to characterize the distributions. These summary statistics include the minimum, most likely, and maximum values of a program evaluation and review technique (PERT) distribution.2 The staff used the PERT distribution to reflect the relative spread and skewness of the distribution defined by the three estimates, the minimum, most likely, and maximum. Appendix A, table A-1, of this document provides the probability distribution function and the descriptive statistics of the inputs used in the uncertainty analysis.

5.2 Uncertainty Analysis Results The NRC performed the Monte Carlo simulation by repeatedly calculating the results 10,000 times. Appendix A provides the inputs used in the uncertainty analysis and additional information regarding the uncertainty analysis results.

For each iteration, the variable values in appendix A were chosen randomly from the probability distributions that define the input variables. The values of the output variables were recorded for each iteration, and these resulting output variable values were used to define the resultant probability distribution.

The results of the uncertainty analysis are provided graphically in figures A-1 through A-13 located in appendix A. These figures display the histograms of the incremental net benefit between the identified alternatives to address that issue. The uncertainty analysis graph results are reported in 2020 dollars using a 7 percent discount rate.

The uncertainty analysis did not include estimates for several issues. Issue 2 has no graph because there are no incremental costs or benefits due to the final rule requirements. Issue 3 has no graph because it was not analyzed, as NRC licensees are not transporting Type C packages (large quantities of nonfissile radioactive material by air). Issue 5 has no graph because the NRC determined that the cost to make a definition change is negligible and included in the NRC rulemaking cost.

Figure A-14 is reproduced here as Figure 1. Figure 1 shows a tornado diagram that identifies the key variables whose uncertainty drives the largest impact on the net benefits for the combined recommended alternativethat is, the recommended alternative for each issue taken together and calculated as an aggregate. Figure 1 ranks the variables based on their contribution to cost uncertainty.

2 A PERT distribution is a special form of the beta distribution with specified minimum and maximum values. The shape parameter is calculated from the defined most likely value. The PERT distribution is similar to a triangular distribution in that it has the same set of three parameters. Technically, it is a special case of a scaled beta (or beta general) distribution. The PERT distribution is generally considered superior to the triangular distribution when the parameters result in a skewed distribution, as the smooth shape of the curve places less emphasis in the direction of skew. Similar to the triangular distribution, the PERT distribution is bounded on both sides and therefore may not be adequate for some modeling purposes if it is desired to capture tail or extreme events.

51 Figure 1 Tornado diagram of rulemaking benefits7 percent NPV The approach to addressing Issues 1, 9, 14, and 4 along with Agreement State implementation costs drives the most uncertainty in the expected benefits. The estimate for Issue 1, Revision of Fissile Exemptions, has two variables that contribute to the greatest variation in the overall results. The two variables are the number of material shipments per year and the costs for these shipments. The uncertainty in the number of shipments results in a change in Issue 1 that will in turn cause a change to the mean of $3.5 million, the difference in averted costs that ranges between ($4.1 million) to ($547,000) with a 90 percent confidence level. The uncertainty in material shipment cost ranges could result in a change in Issue 1 that will change the mean by

$2.4 million, the difference in averted costs that ranges from ($3.5 million) to ($1.2 million) with a 90 percent confidence level. However, table A-2 shows that even with these two large variable uncertainties, the minimum Issue 1 averted costs are $513,000.

Issue 9, Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program, costs affect the variability of the net benefits estimate next in degree with a range of $2.9 million. And next adding variability is uncertainty about NRC implementation costs which range of $1.9 million.

Issue 14, Deletion of 233U Restriction in Fissile General License, also has two variables that contribute to the greatest variation in the overall results. The two variables are the cost per shipment of low-enriched uranium-235 (235U) under Title 10 of the Code of Federal Regulations (10 CFR) 71.22, General license: Fissile material, and the number of shipments. The uncertainty in shipment costs will result in a change to the mean of $1.1 million, the difference between ($3.0 million) and ($1.9 million), with a 90 percent confidence level. The uncertainty in the number of low-enriched 235U shipments will result in a change to the mean of $821,000 (the difference between ($2.8 million) and ($1.9 million)). However, figure A-11 shows that even with these two variable uncertainties, the minimum Issue 14 averted costs are $410,000.

-4.50

-4.00

-3.50

-3.00

-2.50

-2.00

-1.50

-1.00

-0.50

52 The next variable that causes the greatest variation in the incremental costs is the Issue 4 variable for the certificate holders cost to prepare and submit insolation certification requests.

As shown in figure A-14, this level of variation could change the mean by up to $1.1 million (the difference between ($3.1 million) and ($2.0 million)) with a 90 percent confidence level. As shown in figure A-2, the mean cost to implement Issue 4 is ($1.16 million), with a minimum cost of ($321,000) and a maximum cost of ($2.19 million).

Other cost components affect the variability in the net benefit estimates for the final rule to lesser degrees.

6 Other Impacts and Regulatory Considerations This section discusses potential noncost impacts of the two actions, including impacts on licensees and Agreement States.

6.1 Impacts on Licensees and Certificate -Holders The NRCs recommended revisions to 10 CFR Part 71 will not impose new broad programmatic requirements on licensees and certificate holders. However, licensees and certificate holders will need to review any resulting final rule amending 10 CFR Part 71 and update their internal procedures and provide additional training to their staff, as appropriate. Some of the changes may require certificate holders to submit applications for certificate amendments in order to continue using a certificate design, as evaluated in the cost model. Applicants for a new certificate will have to meet the regulations in effect at the time.

Harmonizing NRC regulations with IAEA standards will provide greater regulatory certainty, remove multiplicity of regulations, facilitate international commerce, and reduce the costs of importing and exporting radioactive material for both existing and new licensees and certificate holders.

6.2 Impacts on Agreement States In accordance with the Commissions Agreement State Program Policy Statement; Correction (82 FR 48535; October 18, 2018) [17], this rulemaking will provide compatibility between the radiation control programs of the NRC and the Agreement States, thereby providing consistency among Agreement States and NRC transportation regulations. Implementation costs to the Agreement States will include activities for rule promulgation, public and NRC comment disposition, and codification of the rule through the States legislative process. The rule also changes requirements that are a matter of compatibility with the Agreement States, so Agreement States will need to update their regulations, as appropriate, at which time those licensees located within Agreement States will need to meet the compatible Agreement State regulations. Agreement States will need to add requirements to their State regulations that are compatible with existing NRC regulations in 10 CFR 71.95(a), (b), (c), and (d). Once added, for reports required under 10 CFR 71.95(b), Agreement States will receive and review reports of instances in which the NRC CoC was not followed during transportation to gauge the efficacy of their licensees QAPs. These report reviews will result in operational costs of ($165,654).

No additional operational costs are expected for the changes to the QAP compatibility categories, as the Agreement States were already performing the review, approval, inspection,

53 and enforcement of their licensees QAPs. The final rule will provide them the proper authority to carry out these regulatory functions.

During the rule development, the NRC has analyzed the rule in accordance with the procedure established within Section III, Categorization Process for NRC Program Elements, of Handbook 5.9 to Management Directive 5.9, Adequacy and Compatibility of Program Elements for Agreement State Programs, dated April 26, 2018 [18], and coordinated the rulemaking, consistent with NRC policy and other guidance documents. The NRC regulations or equivalent legally binding requirements should be adopted and implemented in a timeframe such that the effective date of the Agreement State requirement for its licensees is not later than 3 years after the effective date of the NRCs final rule. Certain circumstances (e.g., the adoption of a basic radiation protection standard or other rule that will have significant impact on the regulation of Agreement States on a nationwide basis) may warrant that the effective dates for both NRC licensees and Agreement State licensees be the same.

6.3 Compliance with the National Environmental Policy Act The NRC has made an initial determination that a rulemaking to revise and align 10 CFR Part 71 with the IAEAs and the DOTs regulations will not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. A draft environmental assessment (EA) was performed to identify and evaluate potential environmental impacts, and that draft assessment concludes that no environmental impact statement is required. Accordingly, since there are no significant environmental impacts as evaluated in the EA, any costs for the EA are captured by NRC implementation costs, and no additional operational costs are associated with the EA for licensees, applicants for a CoC, and certificate holders.

6.4 Compliance with the Regulatory Flexibility Act The Regulatory Flexibility Act, enacted in September 1980, requires agencies to consider the effect of their regulatory proposals on small entities, analyze alternatives that minimize effects on small entities, and make their analyses available for public comment. This final rule will affect NRC licensees, including operators of nuclear power plants, who transport or deliver to a carrier for transport relatively large quantities of radioactive material in a single package; holders of a QAP issued under 10 CFR Parts 50, 71, or 72; and holders of a CoC for a transportation package. Except for certain QAP holders and certificate holders, these companies do not typically fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards adopted by the NRC at 10 CFR 2.810, NRC size standards. Reviewing records of these affected entities (QAP holders and certificate holders),

the NRC found that only 10 of 86 of those are small entities. Furthermore, of these 10, the NRC expects that only 7 will be negatively affected by the rule, given these companies lines of business and day-to-day operations. For these reasons, there will not be a significant economic impact on a substantial number of small entities.

7 Cost Analysis Summary and Conclusions Table 35 summarizes the results.

54 Table 33 Alternative 2 Summary Table by Cost Type and Impacted Organization Issue Description Alternative 2 Net Benefits (Costs)2020 dollars at 7% NPV)

NRC Industry (Licensee)

Industry (CoC Holder)

Agreement States Totala 1

Revision of fissile exemptions

$2,907

$2,999,424

$0

$3,002,330 2

Revision of reduced external pressure test for normal conditions of transport

$0

$0 3

Type C package standards Not Analyzed Not Analyzed Not Analyzed Not Analyzed Not Analyzed 4

Revision of insolation requirements for package evaluations

($137,997)

$0

($1,022,551)

$0

($1,160,548) 5 Inclusion of definition for radiation levelb

$0

$0 6

Deletion of the LSA-III leaching test

$0

$59,676

$0

$59,676 7

Inclusion of new definition for surface contaminated object

$490,489

$468,057

$0

$958,547 8

Revision of UF6 package requirements (UF6 cylinder plugs)

($10,792)

$0

($56,340)

$0

($67,132) 9 Inclusion of evaluation of aging mechanisms and a maintenance program

($458,544)

($653,356)

($1,432,648)

$0

($2,544,548) 10 Revision of transitional arrangements

($612,512)

$0

($1,002,390)

$0

($1,614,902) 11 Inclusion of head space for liquid expansion

($1,635)

$0

($4,681)

$0

($6,316) 12 Revision of QAP biennial reporting requirements

($1,572)

$0

($23,386)

$0

($24,958) 13 Deletion of Type A package limitations in fissile material general licenses

$5,790

$13,173

$0

$18,963 14 Deletion of 233U restriction in fissile general license

$0

$1,299,846

$0

$1,299,846 15 Other recommended changes to 10 CFR Part 71

$0

($135,223)

Total Operation Costs (By Issue)

($723,866)

$4,186,821

($3,529,602)

($135,223)

($201,870)

Agreement States Implementation Costs

$0

($2,242,429)

Total Benefit (Cost)

($723,866)

$4,186,821

($3,541,997)

($2,377,652)

($2,456,694) a Averted cost = positive, normal cost is (negative) b Issue 5 costs to change the definition for radiation level are included in the rulemaking estimate in NRC implementation costs.

Based on this evaluation, the NRC has reached the following conclusions.

Alternative 1 maintains the status quo and results in no new direct costs or benefits to the NRC or the licensees, but it does not achieve the stated regulatory objective.

Alternative 2 achieves the following benefits:

The final rule option for Issues 1 and 4-15, in combination with the no-action alternative (Alternative 1) for Issues 2 and 3, will address and resolve all of the regulatory issues of concern and accomplish the goals of the harmonization initiative:

55 Resolving Issues 1, 4, 6-11, and 15 (in part) by a rulemaking action will harmonize the NRCs existing regulations with the current IAEA standards in SSR-6, 2018 Edition.

Resolving Issues 6, 7, 10, 11, and 15 (in part) by a rulemaking action will maintain compatibility between the NRCs regulations in 10 CFR Part 71 and the DOTs regulations in 49 CFR Parts 107 and 171-180.

Resolving Issues 12-15 (in part) by a rulemaking action will improve 10 CFR Part 71 implementation.

The final rule option will reduce the regulatory burden on licensees and certificate holders by maintaining consistency between NRC and DOT regulations and compatibility with IAEA standards, thereby eliminating conflicting requirements.

The final rule option is consistent with the NRCs response to earlier revisions and updates of the international standards by the IAEA. Rulemaking represents the least costly viable option and will result in savings to the industry.

The analysis shows that Alternative 2, recommended by the NRC staff, will result in a total net incremental cost of ($2,547,000). The estimate has the following quantified costs and benefits for licensees, CoC holders, Agreement States, and the NRC:

Licensees will save an estimated $4,186,000.

CoC holders will incur a cost of ($3,542,000).

The NRC will incur a net cost of ($724,000), which consist of net operational costs and no further rulemaking costs after implementation of the rule.

Agreement States will incur a net cost of ($2,378,000) to implement the rule and revise procedures. This estimate includes the implementation cost of the rule by the Agreement States of ($2,242,000). The rulemaking action will also result in marginal operational cost of ($135,000) to the Agreement States.

The rulemaking represents the best option that can address all the issues and could result in a benefit of $645,000 in net averted costs to the industry licensees and CoC holders. Furthermore, the final rule is expected to have important qualitative benefits, including harmonization of the NRC regulations in 10 CFR Part 71 with the IAEAs safety standards, which minimizes potential international commerce disruption and helps to ensure that international obligations are met (e.g., for air transport, the IAEA transport standards serve as the basis for the International Civil Aviation Organization Technical Instructions, as they relate to radioactive material, with which the United States must comply according to the Convention on International Civil Aviationalso known as the Chicago Convention) and assurance that the NRCs regulations continue to be consistent with the DOT regulations for the domestic transportation of radioactive materials. For these reasons, the qualitative benefits of the rule outweigh its costs. One area that the staff did not assess for quantitative benefit is the impact on international commerce over time if the U.S. had regulations that were not compatible with IAEA standards. For example, shipments could be denied or re-routed if U.S. packages are

56 not acceptable in another country. This could be a potentially large cost benefit that could change the rule to quantifiably beneficial. However, due to the unavailability of data, and the staff conclusion that the rulemaking is net beneficial based on qualitative factors, this issue was not assessed.

8 Implementation The NRC assumes that the final rule will become effective 30 days after its publication in the Federal Register in 2025. In response to public comments, the NRC is delaying the compliance date for regulations in § 71.43(d) associated with implementation of aging management and maintenance for radioactive transportation packages to allow the IAEA to finalize a detailed safety guide that is currently in development for aging management and maintenance of radioactive material transport packages. This will help maintain consistency across the international community by ensuring all impacted entities have adequate guidance for implementing aging management and maintenance for radioactive transportation packages. The compliance date for regulations in § 71.43(d) will be January 1, 2029.

9 References

1.

U.S. Nuclear Regulatory Commission, Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements, Federal Register, Vol. 80, No. 113, June 12, 2015, pp. 33988-34018.

2.

U.S. Nuclear Regulatory Commission, Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements; Corrections, Federal Register, Vol. 80, No. 157, August 14, 2015, pp. 48683-48684.

3.

U.S. Department of Transportation, Hazardous Materials: Compatibility With the Regulations of the International Atomic Energy Agency (RRR), Federal Register, Vol. 79, No. 133, July 11, 2014, pp. 40590-40618.

4.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Material: 2009 Edition, Safety Standards Series No. TS-R-1, Vienna, Austria, 2009.

5.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Material: 2012 Edition, Specific Safety Requirements No. SSR-6, Vienna, Austria, 2012.

6.

International Atomic Energy Agency, Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (20xx Edition), Draft Safety Guide DS496 (Revision of SSG-26), Vienna, Austria, August 2017.

7.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Material: 2018 Edition, Specific Safety Requirements No. SSR-6, Rev. 1, Vienna, Austria, 2018.

8.

U.S. Nuclear Regulatory Commission, Rulemaking Plan for Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements, SECY-16-0093, July 28, 2016, Agencywide Documents Access and Management System Accession No. ML16158A164.

9.

U.S. Nuclear Regulatory Commission, Staff RequirementsSECY-16-0093 Rulemaking Plan for Revisions to Transportation Safety Requirements and

57 Harmonization With International Atomic Energy Agency Transportation Requirements, SRM-SECY-16-0093, August 19, 2016, ML16235A182.

10.

U.S. Department of Transportation, Transportation of Radioactive Materials; Memorandum of Understanding, Federal Register, Vol. 44, No. 128, July 2, 1979, pp. 38690-38692.

11.

U.S. Nuclear Regulatory Commission, Issues Paper on Potential Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements, Office of Nuclear Material Safety and Safeguards, Division of Spent Fuel Management, November 15, 2016, ML16299A298.

12.

U.S. Nuclear Regulatory Commission, Revisions to Transportation Safety Requirements and Compatibility With International Atomic Energy Agency Transportation Standards, Federal Register, Vol. 81, No. 224, November 21, 2016, pp. 83171-83174.

13.

U.S. Nuclear Regulatory Commission, Summary of the December 5 and 6, 2016 Public Meeting Regarding Issues Paper on Revisions to Transportation Safety Requirements and Harmonization with the International Atomic Energy Agency Transportation Requirements, December 14, 2016, ML16343A661.

14.

U.S. Nuclear Regulatory Commission, Staff RequirementsSECY-12-0166Proposed Rule: Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements (RIN 3150-AI11),

SRM-SECY-12-0166, February 15, 2013, ML13046A326.

15.

U.S. Nuclear Regulatory Commission, Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Requirements, Federal Register, Vol. 78, No. 95, May 16, 2013, pp. 28988-29016.

16.

U.S. Department of Transportation, Transportation of Radioactive Materials; Memorandum of Understanding, Federal Register, Vol. 44, No. 128, July 2, 1979, pp.

38690-38692.

17.

U.S. Nuclear Regulatory Commission, Agreement State Program Policy Statement; Correction, Federal Register, Vol. 82, No. 200, October 18, 2017, pp. 48535-48539.

18.

U.S. Nuclear Regulatory Commission, Adequacy and Compatibility of Program Elements for Agreement State Programs, Handbook 5.9 to Management Directive 5.9, April 26, 2018, ML18081A070.

19.

U.S. Nuclear Regulatory Commission, Strategic Plan: Fiscal Years 2018-2022, NUREG-1614, Vol. 7, February 2018.

20.

U.S. Nuclear Regulatory Commission, Regulatory Analysis Guidelines of the U.S.

Nuclear Regulatory Commission, NUREG/BR-0058, Rev. 4, September 2004.

21.

U.S. Nuclear Regulatory Commission, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material, Regulatory Guide 7.9, ML050540321.

22.

U.S. Nuclear Regulatory Commission, Draft Regulatory Basis10 CFR Part 71, Harmonization of Transportation Safety Requirements with IAEA Standards, March 2019, ML18262A185.

23.

U.S. Nuclear Regulatory Commission, Harmonization of Transportation Safety Requirements With IAEA Standards, Federal Register, Vol. 84, No. 71, April 12, 2019, pp. 14898-14901.

58

24.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Material: 1985 Edition (as Amended 1990), Safety Series No. 6, Vienna, Austria, 1990.

Available at http://www-pub.iaea.org/MTCD/publications/PDF/Pub1225_web.pdf.

25.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Material: 1996 Edition (Revised), TS-R-1 (ST-1, Revised), Vienna, Austria, 2000.

Available at https://www.iaea.org/publications/6056/regulations-for-the-safe-transport-of-radioactive-material-1996-edition-revised.

26.

U.S. Nuclear Regulatory Commission, Compatibility With IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments, Federal Register, Vol. 69, No. 16, January 26, 2004, pp. 3698-3814.

27.

International Atomic Energy Agency, Regulations for the Safe Transport of Radioactive Materials: 1973 Revised Edition, Safety Series No. 6, Vienna, Austria, 1973. Available at https://gnssn.iaea.org/Superseded%20Safety%20Standards/Safety_Series_006_1973.p df.

28.

U.S. Nuclear Regulatory Commission, Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material, Regulatory Guide 7.10, Rev. 2, March 2005, ML050540330.

29.

U.S. Nuclear Regulatory Commission, Compatibility With International Atomic Energy Agency (IAEA), Federal Register, Vol. 60, No. 188, September 28, 1995, pp. 50248-50289.

30.

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31.

U.S. Nuclear Regulatory Commission, Regulatory Analysis of Major Revision of 10 CFR Part 71: Final Rule, NUREG/CR-6713, 2004, ML033430418.

A-1 Appendix A Cost Uncertainty Analysis Uncertainty Analysis Approach The probability distributions chosen to represent the different variables in the analysis were bounded by the range-referenced input and the U.S. Nuclear Regulatory Commission (NRC) staffs professional judgment. When defining the probability distributions for use in a Monte Carlo simulation, summary statistics are needed to characterize the distributions. These summary statistics include the minimum, most likely, and maximum values of a program evaluation and review technique (PERT) distribution. The staff used the PERT distribution to reflect the relative spread and skewness of the distribution defined by the minimum, most likely, and maximum. Table A-1 at the end of this appendix gives the input variables used in the uncertainty analysis.

Uncertainty Analysis Results Figures A-1 through A-13 show the probability density functions of the incremental net benefit for different issues and alternatives. All graphs are shown based on 7 percent net present value (NPV) calculations. Figure A-14 shows a tornado diagram that identifies the key variables whose uncertainty drives the largest impact on net benefits for this recommended alternative.

Figure A-14 ranks the variables based on their contribution to cost uncertainty.

Figures A-1 through A-13 also display the key statistical results, including the 90 percent confidence interval in which the net benefits will fall between the 5 percent and 95 percent percentile values. The 5 percent and 95 percent values (in other words, the bands marked 5.0% on either side of the 90 percent confidence interval) that appear as numerical values on the top of the vertical lines of the uncertainty figures provided are shown in the next section.

Issue 2 has no graph because there are no costs or benefits due to the final rule requirements.

Issue 3 has no graph because it was not analyzed because of a lack of need by the licensees, and Issue 5 has no graph because the costs for making this definition change in the regulations are included in the NRC implementation costs.

A-2 Figure A-1 Issue 1Revision of fissile exemptions7 percent NPV Figure A-2 Issue 4Revision of insolation requirements for package evaluations7 percent NPV 5.0%

90.0%

5.0%

1.29 5.40 0

1 2

3 4

5 6

7 8

9 Values in Millions ($)

Issue No. 1: Revision of Insolation Requirements for Package Evaluations Minimum

$513,235.38 Maximum

$8,403,472.02 Mean

$3,001,300.75 Std Dev

$1,273,851.34 Values 10000 5.0%

90.0%

5.0%

-1.698

-0.667

-2.20 -2.00

-1.80

-1.60

-1.40

-1.20

-1.00

-0.80

-0.60

-0.40

-0.20 Values in Millions ($)

Issue No. 4: Revision of Insolation Requirements for Package Evaluations Minimum

-$2,185,528.44 Maximum

-$320,552.80 Mean

-$1,160,549.17 Std Dev

$314,529.52 Values 10000

A-3 Figure A-3 Issue 6Deletion of the low specific activity-III leaching test7 percent NPV Figure A-4 Issue 7Inclusion of new definition for surface contaminated object (SCO)-III7 percent NPV 5.0%

90.0%

5.0%

36.59 86.47 20 30 40 50 60 70 80 90 100 110 Values in Thousands ($)

Issue No. 6: Deletion of the Low Specific Activity-III Leaching Test Minimum

$27,819.13 Maximum

$106,399.90 Mean

$59,676.22 Std Dev

$15,225.63 Values 10000

A-4 Figure A-5 Issue 8Revision of uranium hexafluoride (UF6) package requirements (UF6 cylinder plugs)7 percent NPV Figure A-6 Issue 9Inclusion of evaluation of aging mechanisms and a maintenance program7 percent NPV

A-5 Figure A-7 Issue 10Revision of transitional arrangements7 percent NPV Figure A-8 Issue 11Inclusion of head space for liquid expansion7 percent NPV 5.0%

90.0%

5.0%

-1.942

-1.297

-2.40

-2.20

-2.00

-1.80

-1.60

-1.40

-1.20

-1.00 Values in Millions ($)

Issue No. 10: Revision of Transitional Arrangements Minimum

-$2,301,702.31 Maximum

-$1,049,743.41 Mean

-$1,614,902.82 Std Dev

$196,349.20 Values 10000 5.0%

90.0%

5.0%

-6.824

-5.808

-7.40

-7.10

-6.80

-6.50

-6.20

-5.90

-5.60 Values in Thousands ($)

Issue No. 11: Inclusion of Head Space for Liquid Expansion Minimum

-$7,099.94 Maximum

-$5,533.57 Mean

-$6,315.54 Std Dev

$308.99 Values 10000

A-6 Figure A-9 Issue 12Revision of quality assurance program biennial reporting requirements7 percent NPV Figure A-10 Issue 13Deletion of type A package limitations in fissile material general licenses7 percent NPV 5.0%

90.0%

5.0%

-26.149

-24.042

-28.00 -27.50

-27.00

-26.50

-26.00

-25.50

-25.00

-24.50

-24.00

-23.50 Values in Thousands ($)

Issue No. 12: Revision of Quality Assurance Program Biennial Reporting Requirements Minimum

-$27,245.31 Maximum

-$23,803.88 Mean

-$24,958.02 Std Dev

$647.59 Values 10000

A-7 Figure A-11 Issue 14Deletion of uranium-233 (233U) restriction in fissile general license7 percent NPV Figure A-12 Issue 15.1Deletion of duplicative reporting requirements in 10 CFR 71.957 percent NPV

A-8 Figure A-13 Net benefit7 percent NPV Figure A-14 Tornado diagram of rulemaking7 percent NPV Figure A-14 shows a tornado diagram that identifies the key variables whose uncertainty drives the largest impact on net benefits for this recommended alternative. Figure A-14 ranks the variables based on their contribution to cost uncertainty.

-10

-8

-6

-4

-2 0

2 4

6 Values x 10^-7

-$4,104,218.19

-$559,276.65

-$4,222,675.13

-$1,352,484.85

-$3,539,191.88

-$1,175,628.36

-$3,442,074.90

-$1,528,557.42

-$2,999,878.40

-$1,858,824.70

-$3,091,128.29

-$2,026,908.40

-$2,773,424.51

-$1,952,725.05

-$2,853,693.86

-$2,099,085.79

-$2,683,007

-$2,240,001.62

-$2,679,059.84

-$2,237,768.67

-$2,643,040.73

-$2,206,078.33

-$2,622,544.95

-$2,208,932.69

-$2,657,840.92

-$2,251,853.89

-$2,615,737.74

-$2,217,262.21

-$2,656,741.59

-$2,268,715.00

-$2,614,914.38

-$2,279,898.95 Values in Millions ($)

1 - No. of shipments 417(e) fissile 9 - NRC hrs to review application 4 - Cert request prep cost new insolation value 7 - Licensee cost to prepare application 7 - NRC hrs to review and issue exempt request 10 - Licensee preparation upgraded certificates 10 - Licensee new package design costs 10 - NRC hrs to review revised certificates Agreement State hours 14 - No. of shipments of Lo-enriched U235 4 - Cost to evaluate insolation initial condition 14 - Cost per shpment Agreement State rate 1 - Cost per shipment 417(c) 9 - Cost to Prepare & Submit Cert Request 1 - No. of shipments 417(c) 235U Total Benefit Inputs Ranked by Effect on Output Mean Input High Input Low Baseline = -$2,458,509.72

A-9 As shown in figure A-14, the estimate for Issue 1 has two variables that contribute to the greatest variation in the overall results. The two variables are the number of material shipments per year and the costs for these shipments. The uncertainty in the number of shipments results in a change in Issue 1 that will in turn cause a change to the mean of $3.5 million, the difference in averted costs that ranges between ($4.1 million) to ($547,000) with a 90 percent confidence level. The uncertainty in material shipment cost ranges could result in a change in Issue 1 that will change the mean by $2.4 million, the difference in averted costs that ranges from

($3.5 million) to ($1.2 million) with a 90 percent confidence level. However, table A-2 shows that even with these two large variable uncertainties, the minimum Issue 1 averted costs are

$513,000.

Issue 9 Licensee Aging Management costs affect the variability of the net benefits estimate next in degree with a range of $2.9 million. And next adding variability is uncertainty about the rates for Agreement State implementation costs which range of $1.9 million.

Issue 14 also has two variables that contribute to the greatest variation in the overall results.

The two variables are the cost per shipment of low-enriched uranium-235 (235U) under Title 10 of the Code of Federal Regulations (10 CFR) 71.22, General license: Fissile material, and the number of shipments. The uncertainty in shipment costs will result in a change to the mean of

$1.1 million, the difference between ($3.0 million) and ($1.9 million), with a 90 percent confidence level. The uncertainty in the number of low-enriched 235U shipments will result in a change to the mean of $821,000 (the difference between ($2.8 million) and ($1.9 million)).

However, figure A-11 shows that even with these two variable uncertainties, the minimum Issue 14 averted costs are $410,000.

The next variable that causes the greatest variation in the incremental costs is the Issue 4 variable for the certificate holders cost to prepare and submit insolation certification requests.

As shown in figure A-14, this level of variation could change the mean by up to $1.1 million (the difference between ($3.1 million) and ($2.0 million)) with a 90 percent confidence level. As shown in figure A-2, the mean cost to implement Issue 4 is ($1.16 million), with a minimum cost of ($321,000) and a maximum cost of ($2.19 million).

Other cost components affect the variability in the net benefit estimates for the final rule to lesser degrees.

Table A-1 Uncertainty Analysis Input Variables Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate Alternative 2Rulemaking option Issue 1: Revision of Fissile Exemptions Issue 1.a: New Fissile Exceptions in IAEA SSR-6, Paragraph 417 1.a.1.: 417(c)uranium with enrichment up to 5.0 weight percent 235U, up to 3.5 grams 235U per package Number of affected fissile material licensees shipping under this exemption 20 20 Number of shipments of 417(c) material per year 23 PERT 5

20 50 Cost per shipment of 417(c) material

$1,083 PERT

$500

$1,000

$2,000 Number of years 11 11 NRC review and respond to certificate revisions

A-10 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate NRC review of number of affected fissile material licensees to be revised to current (2018) IAEA standards 0

0 NRC review (number of hours) for affected fissile material licensees 0

PERT 0

0 0

1.a.2.: 417(d)up to 2.0 grams fissile nuclides (233U, 235U, 239Pu, or 241Pu) per package, with up to 15 grams fissile nuclides per consignment 0

0 1.a.3.a.: For certificate holdersparagraph 417(e)up to 140 grams fissile nuclides, shipped exclusive use Average number of exemptions per year 0.09 0.0909 Certificate holder's averted (hours) to perform criticality safety evaluation 86.67 PERT 40 80 160 Certificate holder's hourly cost

$203 PERT

$180

$200

$240 Number of years 11 11 NRC review and respond to certificate revisions NRC review of submitted CoC exemptions per year 0.09 0.0909 NRC review hours to review affected fissile material submittals 43 PERT 16 40 80 1.a.3.b.: 417(e)up to 140 grams fissile nuclides, shipped exclusive use Number of affected fissile material licensees shipping under this exemption 30 30 Number of shipments of 417(e) material 11 PERT 5

10 20 Cost savings per shipment of 417(e) material 108 PERT

$50

$100

$200 Number of years 11 11 NRC review and respond to number of affected fissile material licensees to be revised to current (2018) IAEA standards NRC review of number of affected fissile material licensees to be revised to current (2018) IAEA standards 0

0 NRC review (number of hours) for affected fissile material licensees to be revised 0

0 Issue 1.b: Competent Authority-Approved Fissile Exception, SSR-6 Paragraph 417(f) 0 0

Issue 1.c: CSI-Controlled Fissile Material Packages, SSR-6 Paragraph 674 0

0 Issue 1.d: Plutonium Shipments in Type A Packages, SSR-6 Paragraph 675 0

0 Issue 2: Revision of Reduced External Pressure Test for Normal Conditions of Transport 2.a. Licensee preparation of certificate revisions Number of affected certificates of compliance to be revised 0

0 Certificate holder's cost to prepare and submit certification request

($20,000)

($20,000) 2.a. NRC review and respond to certificate revisions NRC review of number of affected fissile material licensees to be revised to current (2018) IAEA standards 0.00 0.00 NRC review applications for revising certificates (Hours) 63.67 PERT 40.00 60.00 102.00 2.b. Licensee preparation of certificate revisions Number of change actions to adopt reduced external pressure requirements 0

0 Licensee's cost to assess the impact of the change

($20,000)

($20,000) 2.b. NRC review and respond to certificate revisions NRC review of number of change actions to adopt reduced external pressure requirements 0

0 NRC review (hours) of change actions to adopt reduced external pressure requirements 63.7 PERT 40.00 60.00 102.00 Issue 3: Type C Package Standards NOT ANALYZED Issue 3: Licensee Preparation of Revised Certificates

3. Licensee preparation of certificate revisions

A-11 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate Number of certificates to be revised to current (2018)

IAEA standards 0

0 Certificate holder's cost to prepare and submit certification request

$20,000

3. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards 0.00 0.00 NRC review applications for revising certificates (Hours) 63.33 PERT 40.00 60.00 100.00 Issue 4: Revision of Insolation Requirements for Package Evaluations Issue 4.a: Insolation for Normal Conditions of Transport 4.a.1. Revise solar insolation for normal conditions of transport for revised certificates Number of certificates to be revised to current (2018)

IAEA standards per year (years 2025 to 2033) 5.8 5.825 Number of certificates to be revised to current (2018)

IAEA standards per year (years 2034 to 2035) 4.2 4.2 Certificate holder's cost to prepare and submit certification request

$8,667 PERT

$2,000

$7,500

$20,000 Number of years 11 11 4.a.1. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards per year (years 2025 to 2033) 5.8 5.825 NRC review of number of certificates to be revised to current (2018) IAEA standards per year (years 2034 to 2035) 4.2 4.2 NRC review applications for revising certificates (hours) 14.83 PERT 5.00 15.00 24.00 4.a.2. Licensee preparation of new certificates Number of new certificates to be approved to current (2018) IAEA standards 1

1 Certificate holder's cost to prepare and submit certification request

$1,083 PERT

$500

$1,000

$2,000 Number of years to next rule change to adopt next version of IAEA standards 11 11 4.a.2. NRC review and respond to new certificate NRC review of number of certificates to be revised to current (2018) IAEA standards per year 1

1 NRC review applications for revising certificates (hours) 5.5 PERT 3

5 10 Issue 4.b: Insolation for Hypothetical Accident Conditions 4.b.1. Revise hypothetical accident conditions input to include insolation Number of certificates to be revised to current (2018)

IAEA standards (years 2025 to 2033) 5.8 5.825 Number of certificates to be revised to current (2018)

IAEA standards (years 2034 to 2035) 4.2 4.2 Certificate holder's cost to prepare and submit certification request

$21,833 PERT

$1,000

$20,000

$50,000 4.b.1. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards (years 2025 to 2335) 5.8 5.825 NRC review of number of certificates to be revised to current (2018) IAEA standards (years 2034 to 2032) 4.2 4.2 NRC review applications for revising certificates (hours) 15 PERT 5

15 24 4.b.2. Licensee preparation of revised certificates Number of new certificates to be approved to current (2018) IAEA standards 1

1 Certificate holder's cost to prepare and submit certification request

$6,500 PERT

$1,000

$2,000

$30,000

A-12 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate Number of years to next rule change to adopt next version of IAEA standards 10 10 4.b.2. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards per year 1

1 NRC review applications for revising certificates (hours) 12 PERT 3

10 30 Issue 5: Inclusion of Definition for Radiation Level 5.a. Licensee costs Number of certificates revised to 2018 IAEA standards 0

0 Licensee cost of preparation of revised applications

$2,750 PERT

$1,000

$2,000

$7,500 5.a. NRC review and respond to certificate revisions Number of revised certificates 5.3 5.25 NRC review applications for revising certificates (hours) 0 0

5.b. Licensee costs Number of nuclear power facilities 0

0 Nuclear power plant licensee cost to revise facility documentation

($15,000)

($15,000) 5.b. NRC review and respond to certificate revisions Number of nuclear power plant licensees' revised facility documentation 60.0 60 NRC review nuclear power plant licensees' revised facility documentation (hours) 0 0

Issue 6: Deletion of the Low Specific Activity-III Leaching Test 6.a. Licensee preparation to assess impact of deletion of the low specific activity-III leaching test Number of low specific activity-III leaching tests 0.45 0.45 Licensee's cost for deletion of the low specific activity-III leaching test

$21,667 PERT

$10,000

$20,000

$40,000 6.a. NRC reserved 6.b. Licensee reserved 6.b. NRC staff needs to consider this issue with respect to the review/revision of NUREG-1608 (hours) 271 PERT 125.00 250.00 500.00 Issue 7: Inclusion of New Definition for Surface Contaminated Object 7.a Licensee assessment of material to qualify as SCO-III Number of decommissioned power plants that may apply this new definition 1.6 1.64 Number of hours for the SCO-III assessment 0

0.00 Licensee cost to prepare application for consideration of 10 CFR 71.41(d)

$50,000 PERT

$25,000

$50,000

$75,000 7.a NRC harmonizes with DOT regulation changes Number of decommissioned power plants that may apply this new definition if DOT 1.6 1.64 NRC staff hours to review and issue each licensee exemption request 10 CFR 71.41 (based on the DOT's decision) 400 PERT 200 400 600 Issue 8: Revision of UF6 Package Requirements (UF6 Cylinder Plugs) 8.a. Licensee preparation of revised certificates Number of certificates to be revised to current (2018)

IAEA standards 0.09 0.0909 Certificate holder's cost to drop UF6 package, prepare and submit certification request for revised CoC

$108,333 PERT

$50,000

$100,000

$200,000 8.a. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards 0.0909 0.0909 NRC review application for revising certificate (hours) 158.42 PERT 100.00 150.00 250.50

A-13 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate 8.b. Licensee preparation of new certificates Number of new or amended certificates 0

0 Certificate holder's cost for additional drop for UF6 package plug, prepare and submit certification request for new CoC

$11,999 PERT

$6,993

$10,000

$25,000 8.b. NRC review and respond to new certificates NRC review of number of new or amended certificates 0

0 NRC review application for revising certificate (hours) 81.67 PERT 40 50 250 Issue 9: Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program 9.a. CoC preparation of upgraded certificates Number of certificates per year to be upgraded to current (2018) IAEA Regs (years 2029 to 2035) 11.6 11.6 Number of certificates per year to be upgraded to current (2018) IAEA Regs (years 2036 to 2043) 3.2 3.2 Certificate Holder's cost to prepare and submit certification request

$36,833 Pert

$5,000

$17,750

$145,000 9.a. Licensee maintenance inspection of casks Number of casks maintained per year (years 2029 to 2035) 111.5 83.6 111.5 139.4 Licensee maintenance cost per cask

$2,260

$1,695

$2,260

$2,825 9.a. NRC review and respond to certificate upgrades NRC review of applications for upgrading certificates to current (2018) IAEA Regs (years 2025 to 2033) 11.6 11.6 NRC review of applications for upgrading certificates to current (2018) IAEA Regs (years 2034 to 2035) 3.2 3.2 NRC Review applications for upgrading certificates (Hours) 90 Pert 30 90 150 Issue 10: Revision of Transitional Arrangements 10.a. Licensee preparation of revised certificates Number of certificates to be revised to current (2018)

IAEA standards (years 2025 to 2033) 5.8 5,825 Number of certificates to be revised to current (2018)

IAEA standards (years 2034 to 2035) 4.2 4.2 Certificate holder's cost to prepare and submit certification request

$20,000 PERT

$10,000

$20,000

$30,000 10.a. NRC review and respond to certificate revisions NRC review of number of certificates to be revised to current (2018) IAEA standards (years 2025 to 2033) 5.8 5.825 NRC review of number of certificates to be revised to current (2018) IAEA standards (years 2034 to 2035) 4.2 4.2 NRC review of licensee reports requesting certificate revisions (hours) 130.00 PERT 60.00 120.00 240.00 10.b. Licensee design, testing/analysis, and preparation of application for new package design Number of certificates to be revised to current (2018)

IAEA standards (years 2025 to 2029) 0.20 0.20 Certificate holder's cost to prepare and submit certification request

$597,500 PERT

$385,000

$575,000

$900,000 10.b. NRC cost to review new package design NRC review of number of certificates to be revised to current (2018) IAEA standards (years 2027 to 2029) 0.33 0.33 NRC review of licensee reports requesting certificate revisions (hours) 1,056 PERT 229 573 3,817 Issue 11: Inclusion of Head Space for Liquid Expansion 11.a. Licensee preparation of revised certificates Number of certificates to be revised to current (2018)

IAEA standards 0.55 0.55 Certificate holder's cost to prepare and submit certification request

($1,500)

A-14 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate 11.a. NRC implementation cost NRC review of number of certificates to be revised to current (2018) IAEA standards 0.55 0.55 NRC time to perform the review of licensee application (hours) 4 PERT 2

4 6

Issue 12: Revision of Quality Assurance Program Biennial Reporting Requirements 12.a. Licensee biennial (every 2 years) change report implementation evaluation Number of licensees to evaluate QAP clarification (one-time occurrence)

(41)

Licensee/certificate holders (hours) to reconcile change to current QAP 10 10 Licensee/certificate holders (cost/hour) to reconcile change to current QAP

$80

$80 12.a. NRC implementation review of biennial QAP report NRC review of number of licensees implementation for QAP clarification (one-time cost) 0.00 0.00 NRC review of licensees implementation for QAP clarification (hours) 0.00 PERT 0

12.b. Licensee biennial (every 2 years) change report submittal Number of licensees to submit QAP biennial report (every two-years) 4 1

3 10 Licensee/certificate holders (hours) to develop and submit biennial report (1)

(1)

Licensee/certificate holders (cost per hour) to develop and submit biennial report

$80

$80 12.b. NRC review of biennial QAP report NRC review of number of licensees biennial report submittals (every 2 years) 4 1

3 10 NRC review of biennial QAP report (hours)

(1)

Issue 13: Deletion of Type A Package Limitations in Fissile Material General Licenses 13.a. Licensee averted costs of criticality evaluation in preparation of new or amended certificates Number of affected certificate holders to adopt 10 CFR 71.22 limit for plutonium 0.18 0.18 Certificate holder hourly cost

$203 PERT

$180

$200

$240 Number of hours to prepare criticality safety evaluation for up to 37grams of plutonium 43 PERT 20 40 80 13.a. NRC averted costs of review of criticality evaluation in new or amended certificates NRC review of number of affected certificate holders to adopt 10 CFR 71.22 limit for plutonium 0.18 0.18 NRC review of criticality evaluation for new or amended certificates (hours) 43 PERT 15 40 80 13.b. Licensee averted costs of shipping in Type B versus Type BF Affected shipments of fissile material under 10 CFR 71.22 general license 3

PERT 1

3 5.0 Cost of shipping Type B versus Type BF package

$233 PERT

$100

$200

$500 Number of licensees 1

1 Number of years 10 10 13.b. NRC review and respond to certificate revisions NRC cost to review number of affected shipments of fissile material under 10 CFR 71.22 general license

$87 PERT

$40

$80

$160 NRC review applications for changing rule (hours) 0.00 0.00 Issue 14: Deletion of 233U Restriction in Fissile General License 14.a. Licensee averted shipments to be able to ship more 235U under 10 CFR 71.22 Number of affected fissile material licensees 11 11 Number of shipments of low-enriched 235U under 10 CFR 71.22 general license 11 PERT 7

10 20 Cost per shipments of low-enriched 235U under 10 CFR 71.22 general license

$1,850 PERT

$800

$1,700

$3,500

A-15 Description Mean Estimate Distribution Low Estimate Best Estimate High Estimate Number of years 11.00 11.00 14.a. NRC review and respond to rule change NRC review of number of exemptions 0.1 0.1 NRC review licensee exemption requests (hours) 0.0 0

Issue 15: Other Recommended Changes to 10 CFR Part 71 15.a. Licensee Other Changes to 10 CFR Part 71 Number of affected fissile material licensees 0

0 15.a. NRC Other Changes to 10 CFR Part 71 NRC review of number of exemptions 0.0 0.0 15.d. Agreement State Other Changes to 10 CFR Part 71 (10 CFR 71.95)

Number of Agreement States (39)

(39)

Number of Agreement State 10 CFR 71.95 reports per year 2

1 2

3 Number of hours per Agreement State to review reports 3

PERT 1

3 5

Rate (hours/$) of Agreement State to support rulemaking activities

$101

$101 15.d. NRC Other Changes to 10 CFR Part 71 (10 CFR 71.95)

NRC review of number of Agreement States reports 0

0 NRC review of licensee reports (hours) 0 PERT 0

0 0

A-16 Table A-2 Descriptive Statistics on the Uncertainty Results (7 Percent NPV)

Issue No.

Issue Title Incremental Costs and Benefits (2020 dollars)a,b Min Max Mean St. Dev.

0.05 0.95 1

Revision of Fissile Exemptions

$513,235

$8,403,472

$3,001,301

$1,273,851

$1,294,734

$5,402,993 2

Revision of Reduced External Pressure Test for Normal Conditions of Transport

$0

$0 3

Type C Package Standards NOT ANALYZED Not Analyzed Not Analyzed Not Analyzed Not Analyzed Not Analyzed Not Analyzed 4

Revision of Insolation Requirements for Package Evaluations

$(2,185,528)

$(320,553)

$(1,160,549)

$314,530

$(1,698,473)

$(667,341) 5 Inclusion of Definition for Radiation Level

$0

$0 6

Deletion of the LSA-III Leaching Test

$27,819

$106,400

$59,676

$15,226

$36,590

$86,471 7

Inclusion of New Definition for Surface Contaminated Object

$540,907

$1,363,958

$958,546

$127,431

$749,753

$1,171,608 8

Revision of UH6 Package Requirements (UF6 Cylinder Plugs)

$(114,836)

$(35,103)

$(67,132)

$14,482

$(92,753)

$(45,199) 9 Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program

$(6,584,653)

$(1,053,712)

$(2,544,578)

$870,994

$(4,227,672)

$(1,443,504) 10 Revision of Transitional Arrangements

$(2,301,702)

$(1,049,743)

$(1,614,903)

$196,349

$(1,942,478)

$(1,296,585) 11 Inclusion of Head Space for Liquid Expansion

$(7,100)

$(5,534)

$(6,316)

$309

$(6,824)

$(5,808) 12 Revision of QAP Biennial Reporting Requirements

$(27,245)

$(23,804)

$(24,958)

$648

$(26,149)

$(24,042) 13 Deletion of Type A Package Limitations in Fissile Material General Licenses

$9,493

$32,049

$18,969

$3,341

$13,768

$24,676 14 Deletion of 233U Restriction in Fissile General License

$410,341

$3,422,176

$1,299,052

$441,993

$686,013

$2,125,018 15 Other Recommended Changes to 10 CFR Part 71

$(307,847)

$(29,521)

$(135,207)

$42,976

$(211,385)

$(70,375) a The staff did not analyze Issue 3 because licensees did not express a need to include Type C standards in NRC regulations for domestic transport.

b There may be differences among tables due to rounding.

OFFICIAL RECORD COPY

SECY-24-0069, Enclosure 4 - Final RA Document (Draft) Part 71

Text

2.1 Background

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