Regulatory Analysis- 10 CFR Part 71, Proposed Rule

Harmonization of Transportation Safety
Requirements with International Atomic
Energy Agency
Proposed Rule—Regulatory Analysis
RIN Number: 3150-AJ85; NRC Docket ID: NRC-2016-0179

AUGUST 2022
U.S. Nuclear Regulatory Commission
Office of Nuclear Material Safety and Safeguards
Division of Rulemaking, Environmental, and Financial Support

[ML22209A039]

Abstract
The U.S. Nuclear Regulatory Commission (NRC), in consultation with the U.S. Department of
Transportation (DOT), is proposing to amend its regulations for the packaging and
transportation of radioactive material. The NRC has historically been consistent in harmonizing
its transportation safety regulations with the 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 for public comment draft
regulatory guide (DG) DG-7011 “Standard Format and Content of Part 71 Applications for
Approval of Packages for Radioactive Material,” which is Revision 3 to Regulatory Guide
(RG) 7.9. 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 proposed rule, “Harmonization of
Transportation Safety Requirements with International Atomic Energy Agency,” and DG-7011.
The rule would result in a net incremental cost of ($542,909). The proposed rule cost estimate
represents the following estimated costs and savings for licensees, certificate of compliance
(CoC) holders, Agreement States, and the NRC:
•

The licensees are estimated to save $5,929,424.

•

The CoC holders are expected to incur a cost of ($2,574,442).

•

The NRC is expected to incur a cost of ($1,489,808), which includes the rulemaking
development and implementation costs ($1,169,291) and an operational cost of
($320,517).

•

Agreement States are expected to incur a net cost of ($2,408,083) to implement the rule
and revise procedures. This estimate includes the implementation cost of the rule by the
Agreement States of ($2,242,429). The rulemaking action will also result in a marginal
operational cost of ($165,654) to the Agreement States.

•

The proposed rule is not cost-justified in that the total net incremental quantitative costs
are estimated to exceed the incremental “averted” costs or savings by ($543,000).
However, the rulemaking represents the best option that can address all the issues and
could result in net savings of $3,354,982 in averted costs to industry. Furthermore, the
proposed rule is expected to have important qualitative benefits, including: (1)
harmonization of the NRC regulations in Part 71 of Title 10 of the Code of Federal
Regulations, “Packaging and Transportation of Radioactive Material,” with the IAEA’s
safety standards, thereby reducing the regulatory burden on the licensees by eliminating
conflicting requirements; (2) assurance that the NRC’s regulations continue to be
consistent with the DOT regulations for domestic transportation of radioactive materials;
and (3) consistency with the NRC’s response to previous revisions and updates of IAEA
standards, without any broad programmatic requirements or significant negative impacts
on the NRC’s licensees or CoC holders. For these reasons, the qualitative benefits of
the rule outweigh its costs.

To improve the credibility of the NRC’s cost estimates for this regulatory action, the NRC
conducted an uncertainty analysis to consider the effects of input uncertainty on the cost
estimate, and a sensitivity analysis to identify the variables that most affect the cost estimate

ii

(i.e., the cost drivers). The NRC’s analysis demonstrates that the proposed rule would result in a
net increase in cost to the industry and the NRC of approximately $543,000 using a 7 percent
discount rate.

iii

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 ..................................................................................................................... ix
1

Introduction ............................................................................................................................ 1

2

Statement of the Problem and Objective ............................................................................... 1

3

4

5

6

2.1

Background .................................................................................................................. 1

2.2

Statement of the Problem ............................................................................................ 2

2.3

Objectives .................................................................................................................... 3

Discussion of Alternatives...................................................................................................... 3
3.1

Action the NRC is Proposing to Take ........................................................................... 3

3.2

Applicability of the Proposed Action ............................................................................. 3

3.3

Proposed Changes to NRC Transportation Regulations.............................................. 4

3.4

Impacted Regulatory Guidance Documents............................................................... 19

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

Uncertainty Analysis ............................................................................................................ 47
5.1

Uncertainty Analysis Assumptions ............................................................................. 47

5.2

Uncertainty Analysis Results ...................................................................................... 47

Other Impacts and Regulatory Considerations .................................................................... 49
6.1

Impacts on Licensees and Certificate Holders ........................................................... 49

6.2

Impacts on Agreement States .................................................................................... 49

6.3

Compliance with the National Environmental Policy Act ............................................ 50

7

Cost Analysis Summary and Conclusions ........................................................................... 51

8

References .......................................................................................................................... 53

Appendix A - Cost Uncertainty Analysis .............................................................................. A-1

iv

List of Figures
Figures
Figure A-1

Page
Issue 1–Revision of Fissile Exemptions–7-Percent NPV ..................................... A-2

Figure A-2

Issue 4–Revision of Insolation Requirements for Package Evaluations–
7-Percent NPV ..................................................................................................... A-2

Figure A-3

Issue 6–Deletion of the Low Specific Activity-III Leaching Test–
7-Percent NPV ..................................................................................................... A-3

Figure A-4

Issue 7–Inclusion of New Definition for
Surface Contaminated Object (SCO-III))–7-Percent NPV .................................... A-3

Figure A-5

Issue 8–Revision of Uranium Hexafluoride Package Requirements
(UF6 Cylinder Plugs)–7-Percent NPV ................................................................... A-4

Figure A-6

Issue 10–Revision of Transitional Arrangements–7-Percent NPV ....................... A-4

Figure A-7

Issue 11–Inclusion of Head Space for Liquid Expansion–7-Percent NPV ........... A-5

Figure A-8

Issue 12–Revision of Quality Assurance Program Biennial Reporting
Requirements–7-Percent NPV ............................................................................. A-5

Figure A-9

Issue 13–Deletion of Type A Package Limitations in
Fissile Material General Licenses–7-Percent NPV .............................................. A-6

Figure A-10 Issue 14–Deletion of 233U Restriction in Fissile General License–
7-Percent NPV ..................................................................................................... A-6
Figure A-11 Issue 15–Deletion of Duplicative Reporting Requirements–
7-Percent NPV ..................................................................................................... A-7
Figure A-12 Net Benefit–7-Percent NPV .................................................................................. A-7
Figure A-13 Tornado Diagram of Rulemaking–7-Percent NPV ............................................... A-8

List of Tables
Tables
Page
Table ES-1 Net Benefits (Costs) by Issue ................................................................................... x
Table ES-2 Net Benefits (Costs) by Affected Entity ...................................................................xii
Table 1

Estimated Averted Cost of Making Shipments with New Fissile Exemption .......... 21

Table 2

Averted Cost to Licensees Using New 140 Gram Fissile Exemption ..................... 22

Table 3

Averted NRC Review Cost for 140 Gram Fissile Exemption .................................. 23

Table 4

Licensee Shipping Benefit Using the 140 Gram Fissile Exemption ....................... 23

Table 5

Cost for Certificate Holders to Prepare an Application Evaluating New Insolation
Value ...................................................................................................................... 25

Table 6

NRC Cost to Review Applications for Revised Certificates of Compliance ............ 25

Table 7

Licensee Averted Costs to Submit Certificate for New Certificate of Compliance.. 26

v

Table 8

NRC Incremental Costs to Review New Certificates of Compliance ...................... 27

Table 9

Certificate Holder Cost to Evaluate Insolation as an Initial Condition..................... 28

Table 10

NRC Cost to Review Applications for Revised Certificates of Compliance ............ 28

Table 11

Licensee Costs to Submit Certificate for New Certificate of Compliance ............... 29

Table 12

NRC Incremental Costs to Review New Certificates of Compliance ...................... 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 ................................... 32

Table 16

Cost to Prepare Application for Revised UF6 Certificate of Compliance ................ 33

Table 17

NRC Cost to Review Application for Certificate Revision ....................................... 34

Table 18

Certificate Holder Cost to Revise Certificates ........................................................ 36

Table 19

NRC Review Time for Revised Certificates Cost ................................................... 36

Table 20

Certificate Holder Cost to Prepare an Application for a
Replacement Package ........................................................................................... 37

Table 21

NRC Review Cost for Reviewing an Application for a
Replacement Package ........................................................................................... 37

Table 22

Licensee Cost to Prepare and Evaluate Liquid Expansion .................................... 38

Table 23

NRC Cost to Evaluate Application for Liquid Expansion ........................................ 39

Table 24

Licensee Cost to Evaluate Program Change for Biennial Report .......................... 40

Table 25

Licensee Cost to Submit Biennial Report ............................................................... 40

Table 26

NRC Cost to Review Biennial Report ..................................................................... 41

Table 27

Averted Licensee Cost to Obtain Approval for Shipment in
Type BF Package ................................................................................................... 42

Table 28

Averted NRC Cost to Review Application for Approval for Shipment in
Type BF Package ................................................................................................... 43

Table 29

Averted Licensee Cost to Make Shipment Using New Type B Package Limits ..... 43

Table 30

Licensee Averted Cost for Transporting Using General License in
10 CFR 71.22 ......................................................................................................... 44

Table 31

Agreement States Costs to Review Reports .......................................................... 46

Table 32

Alternative 2 Summary Table by Cost Type and Impacted Organization ............... 51

Table A-1

Uncertainty Analysis Input Variables .................................................................... A-9

Table A-2

Descriptive Statistics on the Uncertainty Results (7-Percent NPV) .................... A-15

vi

Abbreviations and Acronyms
ACRS
ADAMS

Advisory Committee on Reactor Safeguards
Agencywide Documents Access and Management System

Bq

Becquerel

°C
CFR
Ci
CoC
CSI

degrees Celsius
Code of Federal Regulations
Curie
Certificate of Compliance
Criticality Safety Index

DOE
DOT

U.S. Department of Energy
U.S. Department of Transportation

EA

Environmental Assessment

°F
FR

degrees Fahrenheit
Federal Register

g
g cal/cm2

Gram
Gram-calories per square centimeter

HMR

Hazardous Materials Regulations

IAEA
ISO

International Atomic Energy Agency
International Organization for Standardization

LDM
LSA

Low Dispersible Material
Low Specific Activity

MOU

Memorandum of Understanding

NRC
NPV
NUREG

U.S. Nuclear Regulatory Commission
Net Present Value
Nuclear Regulatory Publication

Pa
psi

Pascal
Pounds Per Square Inch

QAP

Quality Assurance Program

Rem

Roentgen Equivalent Man

SCO
SI
SOC
SRM
SRP

Surface Contaminated Object
International System of Units
statement of consideration
Staff Requirements Memorandum
Standard Review Plan

vii

SSR-6
Sv

IAEA Specific Safety Requirements Number SSR-6, “Regulations for the
Safe Transport of Radioactive Material”
Sievert

TRANSSC

Transportation Safety Standards Committee

UF6

Uranium Hexafluoride

W/m2

Watts per square meter

viii

Executive Summary
On June 12, 2015, the U.S. Nuclear Regulatory Commission (NRC), in consultation with the
U.S. Department of Transportation (DOT), published a final rule that amended the NRC’s
regulations for the packaging and transportation of radioactive material (80 FR 33988; June 12,
2015) [1]. These amendments made conforming changes to the NRC’s regulations based on
the standards of the International Atomic Energy Agency (IAEA). That final rule, in combination
with a DOT final rule (79 FR 40589; July 11, 2014) [3] amending Title 49 of the Code of Federal
Regulations (49 CFR), brought U.S. regulations into general accord with the 2009 edition of the
IAEA’s “Regulations for the Safe Transport of Radioactive Material” (TS-R-1) [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) [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, dated July 28, 2016 [8], the NRC staff requested Commission approval to
initiate a rulemaking related to harmonizing Part 71 of Title 10 of the Code of Federal
Regulations (10 CFR), “Packaging and Transportation of Radioactive Material,” with the
updated IAEA standards in SSR-6, 2012 Edition, along with the then-anticipated 2018 Edition,
and DOT regulations. The Commission approved the NRC staff recommendation via a staff
requirements memorandum, SRM-SECY-16-0093, dated August 19, 2016 [9]. This rulemaking
harmonizing NRC regulations with the 2018 Edition of SSR-6 includes changes made in the
2012 Edition of SSR-6 that have been carried forward to the 2018 Edition.
The DOT 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 (44 FR 38690; July 2, 1979)
[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 for low specific activity (LSA), advance
notification of shipments of irradiated reactor fuel and nuclear waste, Tables A-1 and A-2 in
Appendix A to 10 CFR Part 71, and the changes to Agreement State compatibility categories);
these items have been 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 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 draft regulatory basis [22].
In this regulatory analysis, the NRC considers and evaluates two alternative actions to align the
NRC’s regulations with the IAEA standards and DOT regulations: a no-action option maintaining

ix

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 recommended action by the NRC. Other alternatives that
were considered in the draft regulatory basis and then rejected included issuing generic
communications and regulatory guidance and issuing license-specific conditions and
exemptions. These were rejected because they would not address all the regulatory issues of
concern or would result in higher costs to the NRC and industry.
Table ES-1 below lists the 15 regulatory issues identified and analyzed by the NRC, 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
Net Benefits (Costs) (2020 dollars
at 7% NPV) a,b,c,d,e

Issue No.

Description

1

Revision of Fissile Exemptions
Revision of Reduced External Pressure Test for Normal
Conditions of Transport d

2

d

3

Type C Package Standards

4

Revision of Insolation Requirements for Package Evaluations
e

Inclusion of Definition for Radiation Level

6

Deletion of the Low Specific Activity-III Leaching Test

7

Inclusion of New Definition for Surface Contaminated Object
Revision of Uranium Hexafluoride Package Requirements
(UF6 Cylinder Plugs)
Inclusion of Evaluation of Aging Mechanisms and a
Maintenance Program
Revision of Transitional Arrangements

9
10
11
12
13

$0
Not Analyzed

5

8

$3,678,000

($1,399,000)
$0

Inclusion of Head Space for Liquid Expansion
Revision of Quality Assurance Program Biennial Reporting
Requirements
Deletion of Type A Package Limitations in Fissile Material
General Licenses

14

Deletion of 233U Restriction in Fissile General License

15

Other Recommended Changes to 10 CFR Part 71.95

Operation Costs (By Issue) Total

$73,000
$1,174,000
($82,000)
$0
($1,987,000)
($8,000)
($31,000)
$23,000
$1,592,000
($166,000)
$2,869,000

Non-Issue Specific Benefits (Costs)
NRC Rulemaking Implementation Costs

($1,169,000)

Agreement States Implementation Costs

($2,242,000)

Total Benefits (Costs)
a
b
c
d

($543,000)

The results are sensitive to the timing of when costs and benefits occur and to the discount rate
applied.
The values are rounded to the nearest thousand dollars.
Benefits and averted costs are positive. Costs are (negative).
The NRC did not analyze the costs for Issue 3 because NRC is not proposing to adopt Type C
standards in NRC regulations for domestic transport. The NRC did analyze the costs for Issue 2, and
decided to not propose reduced external pressure test requirements.

x

e

The costs for issue 5 are solely for performing the rulemaking which are calculated in the NRC
implementation costs.

The NRC proposes to conduct rulemaking to address and resolve all issues except for Issues 2
and 3 (no-action to harmonize with SSR-6):
1. IAEA harmonization issues (Issues 1, 4, 5, 6, 7, 8, 9, 10, 11, and 15 (in part)): Staff
assessments of these issues identified potential revisions to harmonize the existing
regulations with the IAEA standards.
2. DOT compatibility issues (Issues 6, 7, 10, 11, and 15 (in part)): NRC assessments of
these issues identified potential revisions to ensure compatibility between revisions
to the NRC regulations in 10 CFR Part 71 and amendments to the DOT regulations.
3. Administrative, editorial, or clarification issues (Issues 12, 13, 14, and 15 (in part)).
NRC assessments of these issues identified potential changes to clarify the
regulations and improve 10 CFR Part 71 implementation.
The total cost in Table ES-2 includes estimates of the NRC implementation costs for 2 years
(2020 and 2021), and the operational costs, where applicable, during the first 11 years after the
effective date of the rule (2022 through 2032, inclusive). The NRC chose this time frame
because, on average, the NRC rulemaking to harmonize 10 CFR Part 71 with the IAEA
standards has followed an 11-year cycle. The total cost is the net present value of costs and
benefits in 2020 dollars. Averted costs are costs of activities and actions performed under the
existing regulations that would no longer be required if the proposed revision to the regulations
is implemented, and they are assigned positive values. Costs are new or additional actions
associated with the rule, if approved, and they are assigned negative values and displayed in
parentheses. For example, the Agreement States rule development cost of ($2,242,429) and
the net cost of ($542,909) are both negative values and are displayed in parentheses.
The estimated costs for the rule, including its associated guidance development, are:
•

The NRC would incur a cost of ($1,489,808), which includes the rulemaking
development and implementation costs of ($1,169,291) and a cost of ($320,517) for
operation.

•

The Agreement States would incur a total net cost of ($2,408,083) to implement the rule,
to adopt equivalent requirements, and revise procedures. This estimate includes the
implementation cost of the rule by the Agreement States of ($2,242,429) and a small
operational cost of ($165,654).

•

The rule would result in a net savings to industry of $3,354,982. This is comprised of a
savings of $5,929,424 to fissile material licensees and nuclear power plant licensees
that ship LSA-III material. However, the NRC expects that certificate holders would incur
costs of ($2,574,442) for changes to regulations that affect their package preparation
and approval.

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

xi

Table ES-2 Net Benefits (Costs) by Affected Entity
Issue
No.
1
2

Description
Revision of Fissile Exemptions
Revision of Reduced External Pressure
Test for Normal Conditions of Transport
Type C Package Standards
Revision of Insolation Requirements for
Package Evaluations
Inclusion of Definition for Radiation
Level
Deletion of the Low Specific Activity-III
Leaching Test
Inclusion of New Definition for Surface
Contaminated Object
Revision of Uranium Hexafluoride
Package Requirements (UF6 Cylinder
Plugs)
Inclusion of Evaluation of Aging
Mechanisms and a Maintenance
Program
Revision of Transitional Arrangements
Inclusion of Head Space for Liquid
Expansion
Revision of Quality Assurance Program
Biennial Reporting Requirements
Deletion of Type A Package Limitations
in Fissile Material General Licenses
Deletion of 233U Restriction in Fissile
General License
Other Recommended Changes to 10
CFR 71.95

Alternative 2 Net Benefits (Costs)–2020 dollars at 7% NPV)
Industry
Industry
Agreement
NRC
Total a b
(Licensee)
(CoC Holder)
States
$3,561
$3,674,423
$0
$0
$3,677,984
$0

$0

$0

$0

$0

$0

$0

$0

$0

$0

($168,222)

$0

($1,230,879)

$0

($1,399,102)

$0

$0

$0

$0

$0

$0

$73,106

$0

$0

$73,106

$600,913

$573,391

$0

$0

$1,174,304

($13,221)

$0

($69,019)

$0

($82,241)

$0

$0

$0

$0

$0

($746,713)

$0

($1,240,161)

$0

($1,986,874)

($2,003)

$0

($5,734)

$0

($7,737)

($1,926)

$0

($28,649)

$0

($30,575)

$7,094

$16,137

$0

$0

$23,231

$0

$1,592,368

$0

$0

$1,592,368

$0

$0

$0

($165,654)

($165,654)

($320,517)

$5,929,424

($2,574,442)

($165,654)

$2,868,811

NRC Rulemaking Implementation (Costs)

($1,169,291)

$0

$0

$0

($1,169,291)

Agreement States Implementation (Costs)

$0

$0

$0

($2,242,429)

($2,242,429)

($1,489,808)

$5,929,424

($2,574,442)

($2,408,083)

($542,909)

3
4
5
6
7
8
9
10
11
12
13
14
15

Operational (Costs) (By Issue) Total
Non-Issue Specific Benefits (Costs)

Total Benefit (Cost)
a
b

NPV = net present value
Averted cost = positive, normal cost is (negative)

The estimated net cost of the rule is approximately ($542,909). These costs are dominated by
NRC rulemaking costs and costs by Agreement States to promulgate and implement the rule
and revise procedures accordingly. However, the staff determined that rulemaking is the only
option that can meet all regulatory objectives and that it would result in net savings to the
industry. Furthermore, the rule is expected to have important qualitative benefits, including
harmonization of the NRC regulations in 10 CFR Part 71 with the IAEA’s 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 U.S. must comply according to the Convention on
International Civil Aviation - also known as the Chicago Convention), and assurance that the
NRC’s regulations continue to be consistent with DOT regulations for the domestic
transportation of radioactive materials. For these reasons, the qualitative benefits of the rule
outweigh its costs.

xii

1

Introduction

In SECY-16-0093, 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 Part 71 of Title 10 of the Code of Federal Regulations (10 CFR), “Packaging and
Transportation of Radioactive Material,” with the International Atomic Energy Agency’s (IAEA)
transportation safety standards and the U.S. Department of Transportation’s (DOT) standards
and (2) make staff-initiated administrative, editorial, or clarifying changes to 10 CFR Part 71.
More specifically, the rulemaking would revise and harmonize the NRC’s regulations for
packaging and transportation with the 2018 Edition of the IAEA’s Specific Safety Requirements
No. 6 (SSR-6) [7], ensure compatibility with DOT regulations, and make NRC staff-initiated
changes. Harmonizing NRC regulations with the 2018 Edition of SSR-6 includes changes made
in the 2012 Edition of SSR-6 that have been carried forward to the 2018 Edition. The
Commission approved the NRC staff recommendation via a staff requirements memorandum
(SRM) to 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 Parts 107 and 171-180 of Title 49 of the Code of Federal Regulations
(49 CFR) with the IAEA’s standards in the 2018 Edition of SSR-6.

2
2.1

Statement of the Problem and Objective
Background

The IAEA establishes safety standards to protect public health and safety and to minimize the
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 U.S. 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 that material. By periodically revising NRC regulations to be
compatible with IAEA standards and DOT regulations, the NRC is able to remove
inconsistencies that could impede international commerce for NRC licensees.
The roles of the DOT and the NRC in the coregulation of the transportation of radioactive
materials are documented in a Memorandum of Understanding (44 FR 38690; July 2, 1979)
[10]. Because the DOT and the NRC coregulate transportation of radioactive materials in the
U.S., the two agencies have historically coordinated to harmonize their respective regulations to
the IAEA revisions through the rulemaking process. In the NRC’s previous 10 CFR Part 71
harmonization rulemaking, published in the Federal Register on June 12, 2015 [1], the
Commission stated that the NRC 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 proposed rule 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 regulations for
the transportation of radioactive material in 49 CFR Parts 107 and 171-180 with the 2018
Edition of SSR-6.
1

The NRC reviewed the 2018 Edition of the IAEA standard 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 the issues paper [11]. A notice of the issues paper, public meeting, and request
for comment was published in the Federal Register (81 FR 83171; 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, and these potential
changes were grouped under a new issue that was designated as Issue 15.
On April 12, 2019, the NRC noticed the draft regulatory basis for this rulemaking in the Federal
Register and requested public comments (84 FR 14898; April 12, 2019) [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 proposed rule.
In the draft regulatory basis, the NRC evaluated four alternative actions for each issue. These
were: (1) a no-action option that would maintain the status quo (Alternative 1); (2) issue generic
communications and regulatory guidance (Alternative 2); (3) issue license-specific conditions
and exemptions (Alternative 3); and (4) initiate 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 determined that
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, is the NRC-recommended action because it
represents the best and least costly option. Alternatives 2 and 3 would not address all the
regulatory issues or would result in higher costs to the NRC and industry and, therefore, have
not been carried forward to the proposed rule. As a result, this regulatory analysis renames
Alternative 4 as Alternative 2. While the NRC is not proposing to adopt IAEA changes for Issue
5, the NRC is proposing to clarify the meaning of radiation level. After subsequent evaluation
during the development of the proposed rule, the NRC determined that the no-action alternative
(Alternative 1) for Issue 2 is appropriate.

2.2

Statement of the Problem

Compatibility of the U.S. domestic regulations with the international standards provides a
consistent basis for safe packaging and transportation of radioactive material, reduces
impediments to trade, facilitates international cooperation, reduces safety risk associated with
the import and export of radioactive material, and can be expected to have safety benefits. If the
NRC does not pursue rulemaking it will result in inconsistencies and differences between the
NRC’s regulations and the IAEA’s standards, as well as the DOT’s 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 NRC and foreign competent
authorities can impede international transport. Also, the IAEA has periodically changed its
standards to take advantage of increased knowledge and industry experience, and without this
2

proposed harmonization, 10 CFR Part 71 regulations would continue to diverge from the
international standards. A decision not to harmonize 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 NRC’s regulations with the IAEA
standards: a no-action option that would maintain the status quo (Alternative 1); and a
rulemaking option that would 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.”

2.3

Objectives

Consistent with the rulemaking process, this regulatory analysis describes and documents the
results of assessments and analyses performed by the NRC in support of the proposed 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
3.1

Discussion of Alternatives
Action the NRC is Proposing to Take

The NRC is proposing to amend its regulations to harmonize them with SSR-6, 2018 Edition.
These revisions also would be consistent with the DOT’s hazardous materials regulations, as
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, the proposed rule would 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 the
Agreement States to adopt equivalent requirements.

3.2

Applicability of the Proposed Action

This action would 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, or transports the material outside of the site of usage as
specified in the NRC license, or transports that material on public highways; (2) holders of, and
applicants for, a CoC under 10 CFR Part 71; and (3) holders of a 10 CFR Part 71 quality
assurance program (QAP) approval. This action also would change regulations that are a matter
of compatibility with the Agreement States. Therefore, the Agreement States would need to
update their regulations, as appropriate, at which time those licensees located within Agreement
States would need to meet the compatible Agreement State regulations.

3

3.3

Proposed Changes to NRC Transportation Regulations

The NRC is proposing to revise 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 would also improve or maintain consistency between 10 CFR Part 71 and DOT
regulations under 49 CFR to maintain a consistent domestic framework for the packaging and
transportation of radioactive material. To accomplish these goals, the NRC is proposing to
revise 10 CFR Part 71 as described in the following sections.
For each of the issues, this regulatory analysis considers two options: Alternative 1, the NoAction alternative, and Alternative 2, to pursue rulemaking to amend 10 CFR Part 71, and
describes the advantages and disadvantages of each alternative.
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
and/or conveyance.
The NRC proposes to incorporate SSR-6 paragraph 417(c) into a new provision under
10 CFR 71.15 for 3.5 grams or less 235U, provided the uranium is enriched in 235U to a maximum
of 5 percent by weight, and the total plutonium and 233U content does not exceed 1 percent of
the mass of 235U. The NRC is not proposing to incorporate the associated consignment limit of
IAEA SSR-6 paragraph 570(c). The NRC also proposes to incorporate SSR-6 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 is not proposing to incorporate the IAEA SSR-6 fissile exception in paragraph 417(d).
Alternative 1: No-Action Alternative
Under the no-action alternative, the two proposed additions to the 10 CFR Part 71 fissile
exemptions described in Issue 1a would not be made, and licensees wishing to ship the
amounts of fissile material described in these proposed changes would 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 and 71.59. This alternative would leave the
fissile exempt material requirements in 10 CFR 71.15 unchanged and these requirements would
not be harmonized with similar requirements in SSR-6, 2018 Edition.
Alternative 2: Revise 10 CFR Part 71
If the NRC were to complete the proposed rulemaking, the fissile exemption changes in 10 CFR
71.15 would be codified, and it would 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 71.59. Additionally, the changes would meet the intent of
the fissile exemptions, in that licensees could self-certify packages for shipping the amount of
material described in the two proposed changes. If the NRC were to move forward with the
proposed rulemaking, the fissile exemptions in 10 CFR 71.15 would be more consistent with
similar provisions in IAEA SSR-6 paragraph 417. Since harmonization with IAEA SSR-6, to the
extent described above, facilitates the safe transportation of fissile material internationally,
performing the rulemaking as proposed is the staff-recommended alternative.
4

3.3.2

Issue 2. Revision of Reduced External Pressure Test for Normal Conditions of
Transport

The NRC has decided not to further pursue any changes to the reduced external pressure test
requirement under 10 CFR Part 71.71(c)(3). As a result, no further discussion or analysis is
presented in this regulatory analysis on that issue.
3.3.3

Issue 3. Type C Package Standards

The NRC has decided not to further pursue any changes to 10 CFR Part 71 to adopt Type C
package standards. As a result, no further discussion or analysis is presented in this regulatory
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 proposing changes to 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(b).
3.3.4.1

Issue 4.1 Unit of Measure for Insolation for Normal Conditions of Transport

The NRC previously harmonized its regulations with the 1985 Edition of Safety Series No. 6
(60 FR 50248; September 28, 1995). That final rule neither discussed nor proposed changing
the units on the heat test for normal conditions of transport in 10 CFR 71.71(c)(1).
Consequently, the current units for insolation in 10 CFR Part 71 are “g cal/cm2.” This is
inconsistent with IAEA standards in the 2018 Edition of SSR-6. As a result, NRC package
approvals are evaluated for less insolation than that prescribed by IAEA standards and 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 the 2018 Edition of SSR-6.
Alternative 1: No-Action Alternative
In considering the no-action alternative, since the NRC values for insolation are lower than the
equivalent values in IAEA’s SSR-6, 2018 Edition, applicants for a transportation CoC can
voluntarily use the IAEA values and still meet NRC 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
reviewing a DOT certificate of competent authority for revalidation for international
transportation.

5

Alternative 2: Revise 10 CFR Part 71
Under this alternative, the NRC would 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 would ensure that thermal analyses performed for package approval
in the U.S. have the same conditions as those that use IAEA standards for normal conditions of
transport. Since regulatory consistency would be achieved, performing the rulemaking is the
preferred alternative.
3.3.4.2

Issue 4.2 Initial Conditions for Hypothetical Accident Conditions

In Safety Series No. 6, “Regulations for the Safe Transport of Radioactive Material, 1985 Edition
(as amended in 1990)” [24], paragraph 628 stated:
With respect to the initial conditions for the thermal test, the demonstration of
compliance shall be based upon the assumption that the package is in
equilibrium at an ambient temperature of 38°C. The effects of radiation may be
neglected prior to and during the tests but must be taken into account in the
subsequent evaluation of the package response.
The thermal test, previously in paragraph 628, was moved to paragraph 728 in the 1996 Edition
of TS-R-1 [25] and revised to state:
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.
When the NRC revised its regulations in 2004 to harmonize with the 1996 IAEA standard
(69 FR 3697; January 26, 2004) [26], the NRC did not revise the initial conditions of the fire test
listed in 10 CFR 71.73(b) to explicitly require evaluation of insolation as an initial condition.
Alternative 1: No-Action Alternative
In the no-action alternative, the NRC would not move forward with the proposed rule but would
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 would not explicitly state that
insolation is an initial condition to the fire test and NRC regulations would not be harmonized
with the IAEA standards for transport of radioactive material.
Alternative 2: Revise 10 CFR Part 71
Under this alternative, the NRC would undertake rulemaking to require insolation as an initial
condition to the fire test in 10 CFR 71.73(b) for hypothetical accident conditions. The regulation
would be consistent with the IAEA’s SSR-6, 2018 Edition, and with requirements in use by other
foreign competent authorities, obviating the need for questions about whether insolation was
considered in the initial conditions of the tests for hypothetical accident conditions. Since
regulatory consistency would be achieved, performing the rulemaking is the preferred
alternative.

6

3.3.5

Issue 5. Inclusion of Definition for Radiation Level

In the 2018 Edition of SSR-6, the IAEA replaced the term “radiation level” with the term “dose
rate” and defined the dose rate to be the dose-equivalent per unit time. However, such a change
would result in cost impacts to licensees to change documentation and potentially training
programs, with no safety benefit. Therefore, in order to minimize the burden to licensees, the
NRC is proposing to clarify the term radiation level by adding a definition to 10 CFR 71.4. 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 would not change the regulations or guidance. Since this is solely an
issue of what to name the dose rate measurements and calculations, there would be no impact
to safety by choosing this option.
Alternative 2: Revise 10 CFR Part 71
Rulemaking would 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
would 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 for low specific activity category III (i.e., 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 proposing to remove
10 CFR 71.77 and make corresponding revisions to 10 CFR 71.4 and 71.100 to remove
reference to the leaching test.
Alternative 1: No-Action Alternative
The no-action alternative would not change the regulations and the leaching test would remain
in 10 CFR 71.77. Retaining the status quo would 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 the test, an inconsistency would
result for this issue. Such an outcome would 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 is proposing to 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 leaching test would be removed from 10 CFR Part 71. Revising 10 CFR
Part 71 to remove the LSA-III leaching test would also result in a reduction in burden and an
averted cost to shippers of radioactive material due to the regulatory relief that is achieved by
deleting this test requirement for LSA-III material.

7

An international working group concluded that the then-currently required leaching test for LSAIII material did not contribute to the 50 mSv effective dose transport safety limit. Therefore, the
working group recommended to the Transport Safety Standards Committee (TRANSSC) 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 TRANSSC made the decision to remove the test from
the transport regulations. The NRC recognizes the working group’s information and is
recommending harmonizing the NRC’s regulations with SSR-6, 2018 Edition, and remove 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. Efficiencies would be gained for the NRC and for licensees
by having a regulatory definition for a third category of large surface contaminated objects.
Currently, the regulations in 10 CFR 71.4 contain two definitions for SCO: SCO-I and SCO-II.
Harmonization with SSR-6, 2018 Edition, would add the new SCO-III category and the
associated definition.
The NRC is proposing to 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 would similarly adopt
as part of their harmonization rulemaking.
Alternative 1: No-Action Alternative
The no-action alternative would not add a definition for SCO-III to 10 CFR Part 71. This would
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 would 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 DOT and 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 proposes to 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 Memorandum of Understanding (MOU) delineates that 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 49 CFR 173.427, 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 and 173.427) to include the SCO-III definition and transportation requirements.

8

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 inleakage of water into the containment system provided certain conditions are met, including that
the uranium is enriched to not more than 5 weight percent in 235U. In order to use this exception,
the applicant must demonstrate that, following the tests for hypothetical accident conditions in
10 CFR 71.73, there is “no physical contact between the valve body and any other component
of the packaging, other than at its original point of attachment, and the valve remains leak tight.”
In the SSR-6, 2018 Edition, the IAEA added the same requirement for the plug as was added in
the 1996 Edition of TS-R-1 for the valve to ensure that the entire cylinder remains leak tight. In
order to ensure criticality safety, both the plug and the valve must remain leak tight after the
tests for hypothetical accident conditions, to prevent ingress of water into the cylinder.
Alternative 1: No-Action Alternative
In the no-action alternative, under the existing requirements in 10 CFR 71.55(g), the NRC would
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
would be different from that of the IAEA and other IAEA Member States who have adopted the
IAEA requirement; therefore, foreign competent authorities may question certificate holders
about whether the plug on NRC-approved packages 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 would ensure that the 30B cylinder in NRC-approved
packages, which is used world-wide 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 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
aging, because the effects of aging are due to a reaction (e.g., oxidation-, chemical-, or
radiation-induced reactions), NRC regulations at 10 CFR 71.43(d) require no significant
reactions that would affect package aging. The evaluation in the application of whether package
components degrade over time and the quantified effect of that degradation on package
performance can determine whether a periodic test to evaluate the components efficacy or a
replacement/repair schedule, or both, is included in the maintenance program chapter of the
application.
The maintenance program chapter in the application includes periodic testing requirements,
inspections, and replacement criteria and schedules for replacement and repair of components,
9

on an as-needed basis to ensure that the package components meet the requirements 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 would not move forward with the rulemaking and,
consistent with NRC regulations in 10 CFR 71.43(d), would continue to verify in package
certificate reviews that applicants for a CoC appropriately evaluate aging effects and ensure that
the applicants describe the maintenance program as part of their applications. The
disadvantage to this alternative is that the regulations would not explicitly require evaluation of
aging management and a description of the maintenance program in the application.
Alternative 2: Revise 10 CFR Part 71
Under this alternative, the NRC would make its regulations consistent with SSR-6 by requiring
applications for package approval to contain a description of the maintenance program and how
the effects of aging of package components are evaluated. While these items are already
reviewed as part of a package approval, consistent regulations would ensure that there is a
consistent world-wide regulatory framework for radioactive material transport. Since regulatory
consistency would be achieved, performing the rulemaking is the preferred alternative.
3.3.10 Issue 10. Transitional Arrangements
Historically, IAEA, DOT, and NRC regulations have included transitional arrangements or
"grandfathering" provisions 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 the existing regulations do not become "unsafe" when the regulations
are revised (unless a significant safety issue is corrected in the revision).
Typically, the transitional arrangements include provisions that allow for: (1) continued use of
existing package designs and packagings already fabricated; and completion of packagings in
the process of being fabricated, although some restrictions on fabrication of 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.
The IAEA updated its transitional arrangements in paragraphs 819 through 823 of SSR-6, 2018
Edition. In addition, 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 would not make any rule changes. Packages approved to
the NRC’s regulations harmonized with the 1973 Edition of Safety Series No. 6 standard would
not be phased out; there would be no further restrictions to packages with a “-85” or “-96” in the
package identification number; and the NRC would not be able to issue CoCs that are
consistent with IAEA SSR-6, 2018 Edition.

10

While the NRC would 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 would not be able to be transported internationally without the need
to obtain 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 U.S.) and, as
appropriate, all countries that the package would pass through. It is not clear whether other
countries would be willing to issue a special authorization for every one of these shipments
using older package designs.
The NRC would not add the restriction on fabrication for packages after December 31, 2028, for
packages that have a “-96” in the package identification number. The result would be that there
may be identical packages that, depending on the date of fabrication (before or after
December 31, 2028), would have different international transport requirements. Packages
fabricated before December 31, 2028 would be able to be transported internationally, with
multilateral approval. The same package fabricated after December 31, 2028 would need 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 U.S.) and, as appropriate, all countries
that the package would pass through.
The NRC would not revise its definition of “special form radioactive material,” resulting in
inconsistent regulations on 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, would be
authorized for transport under NRC regulations but would 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 would 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 would 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 U.S. for transportation of radioactive material, if the DOT
harmonizes its regulations for transitional arrangements with those of the IAEA and the NRC did
not, then the NRC regulations for domestic transport of radioactive material would 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 to NRC
regulations harmonized with the SSR-6, 2018 Edition, after December 31, 2025, then any
licensee, who desires to ship radioactive material internationally would have to request a special
permit from DOT and NRC licensees would have to request an exemption from NRC. (State
licensees would need to request an exemption from its state regulatory body.) The NRC
licensee would request an exemption from the NRC requirements in 10 CFR 71.19(d) to obtain
package approvals to the latest version of SSR-6. These actions would be needed for each
package, from each licensee using the package for import/export, rather than from certificate
holders.

11

Alternative 2: Revise 10 CFR Part 71
The rulemaking would make transitional arrangements in 10 CFR Part 71 consistent with the
IAEA standards, as follows:
1. Phase out the use of packages approved to NRC regulations that were harmonized with
the IAEA’s Safety Series No. 6, 1973 Revised Edition, [27], 8 years after the effective date
of this rulemaking. These packages would be required to be re-certified, removed from
service, or used via exemption.
2. Discontinue the use of packages with a “-96” in the package identification number for those
packages fabricated after December 31, 2028, and for packages to be used for
international shipment, require multilateral approval, as defined in 49 CFR 173.403,
“Definitions.” Revise § 71.17(e) to state that packages with a “-96” in the package
identification number would become previously approved packages and subject to the
current 71.19(c).
3. Coordinate with the DOT and make appropriate changes to 10 CFR 71.4 to align with the
definition of “special form radioactive material” that the DOT is proposing to adopt as part of
their harmonization rulemaking, since DOT is the lead for certifying special form sources.
4. 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 since it would 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 NRC’s regulations in 10 CFR 71.87, “Routine determinations,” require, in part, that “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 that in DOT’s regulations in
49 CFR 173.412(k) for Type A packages and SSR-6 paragraph 649 for Type A packages and
paragraphs 652 and 667 for Type B(U) and Type B(M) packages, respectively, in SSR-6, 2018
Edition.
The NRC does not have a design requirement for Type AF and Type B packages in 10 CFR
Part 71 comparable to that in DOT’s regulations in 49 CFR 173.412(k) for Type A packages and
SSR-6 paragraph 649 for Type A packages and paragraphs 652 and 667 for Type B(U) and
Type B(M) packages, respectively, in SSR-6, 2018 Edition.
The NRC is proposing to 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.

12

Alternative 1: No-Action Alternative
In the no-action alternative, the NRC would 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 would continue to ensure that package operating procedures complied 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 would not have a
compatible regulation for adequate head space for Type AF packages and Type B packages as
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 would be different from DOT
regulations and IAEA standards.
Alternative 2: Revise 10 CFR Part 71
Rulemaking would 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 would ensure that during the design phase, the NRC staff
would 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 regulations and 10
CFR 71.106 was added to establish requirements that applied to changes to QAPs and included
associated reporting requirements to the NRC. According to the language provided in the
preamble of the 2015 final rule (80 FR 33988; June 12, 2015), if no changes were made to the
QAP in the preceding 24 months, the NRC would expect a report to be submitted stating no
changes were made. In addition, the NRC’s guidance document for 10 CFR Part 71 QAPs,
Regulatory Guide (RG) 7.10 [28], states that if no changes were made to the QAP, a QAP
approval holder would indicate to the NRC that no changes were made. The requirement for a
report 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 it was silent on this point.
The NRC is proposing to revise 10 CFR 71.106(b) to achieve NRC’s 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 would 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 would continue to exist because of the
inconsistency between the current regulatory language in 10 CFR 71.106(b) and RG 7.10
guidance.

13

Alternative 2: Revise 10 CFR Part 71
Under this alternative, the NRC would perform the rulemaking as proposed to remove regulatory
uncertainty, achieve the NRC’s 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 Part 71 QAP approval holders also relies on having current information about the
QAP available to the NRC so 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 Part 71 would be consistent
with those in 10 CFR 50.54(a)(3) and 50.71(e)(2) for Part 50 QAPs.
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 and 10 CFR 71.23 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 is proposing to remove the restriction in 10 CFR 71.22 and 71.23 to ship Type A
material in only a Type A package (i.e., allowing shipment in a Type B package), which would
correct the inconsistences between the mass limits and package restrictions discussed above.
Additionally, the NRC is proposing to 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 would not make the proposed change to 10 CFR
71.22 and 10 CFR 71.23, and licensees would 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
which 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
If the NRC were to complete the rulemaking, 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 calculations that support the existing mass limits. Additionally, the
proposed change would 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 via the equations in each provision. The three new
paragraphs in §§ 71.22 and 71.23, and the conforming changes to § 71.0(d)(1) would also
14

ensure similar requirements for licensees using these general licenses as in § 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 would
be consistent with the intent of the general licenses. Because this change would facilitate the
safe transportation of small quantities of fissile material without explicit NRC approval, thereby
enhancing regulatory efficiency, performing the rulemaking is the staff recommended
alternative. Additionally, the intent of 10 CFR 71.23 would 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 or 71-2.
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 one
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 which 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 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 one
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
proposing to revise 10 CFR 71.22 to limit the 233U to less than one 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 would not make the proposed change to 10 CFR
71.22, and licensees would continue to be limited 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
If the NRC were to complete the rulemaking, 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 proposed change would
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 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 one percent of the
mass of 235U, 10 CFR 71.22 would remain consistent with the intent of the general license, while
allowing greater quantities of fissile material to be shipped under this provision. This change
would facilitate the safe transportation of small quantities of fissile material without explicit NRC
approval, thereby enhancing regulatory efficiency.

15

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 a 2004 final rule (69 FR 3698; January 26, 2004) [26], the NRC added paragraph (a)(3) to 10
CFR 71.95, which introduced duplicative language between paragraph (a)(3) and paragraph (b).
The NRC is proposing to delete the text in paragraph (a)(3).
Alternative 1: No-Action Alternative
Under the no-action alternative, the NRC would not delete the requirements in 10
CFR 71.95(a)(3). NRC licensees would be required by both 10 CFR 71.95(a)(3) and 10
CFR 71.95(b) to submit a report when shipments 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) would not change the reporting
requirements for licensees who perform a shipment that is not in accordance with the
regulations, since reporting would still be required under 10 CFR 71.95(b). However, this
alternative would remove the duplicative requirement.
3.3.15.2

Issue 15.2 Revise the Definition of LSA in 10 CFR 71.4

The NRC is considering 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 would make the definition of LSA in 10 CFR 71.4 consistent with
the title and intent of 10 CFR 71.15, “Exemption from classification as fissile material.”
Alternative 1: No-Action Alternative
Under the no-action alternative, the definition of LSA material would continue to be inconsistent
with the title and intent of 10 CFR 71.15, “Exemption from classification as fissile material.” This
inconsistency could lead to confusion over the difference in terms.
Alternative 2: Revise 10 CFR Part 71
If the NRC were to complete the rulemaking, the definition of LSA would be consistent with the
title of 10 CFR 71.15 and 10 CFR Part 71 would be more internally consistent. Also, there would
be less potential confusion regarding the intent of the definition of LSA regarding fissile exempt
material.
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 and 49 CFR 173.436, respectively. The NRC has corresponding information in 10 CFR
Part 71, Appendix A, Tables A-1 and A-2.
16

In its concurrent harmonization rulemaking, the DOT is proposing to make changes to 49 CFR
173.435 and 173.436 by adding seven radionuclides, including Barium-135m, Germanium-69,
Iridium-193m, Nickel-57, Strontium-83, Terbium-149 and Terbium-161. The NRC is proposing to
make corresponding changes to Tables A-1 and A-2 to add these radionuclides. The NRC is
proposing to revise the specific activity of natural rubidium to correct an error that was
introduced in the 1995 version of the rule. Table A-1 of Appendix A to 10 CFR Part 71 gives the
specific activity as 6.7×106 TBq/g, 1.8×108 Ci/g. The A1 and A2 values were not impacted by this
error and remain correct. The NRC is also proposing to revise Footnote c at the end of Table A2 to state that in the case of thorium-natural, the parent radionuclide is 232Th, and in the case of
uranium-natural, the parent radionuclide is 238U. Further, the NRC is proposing to editorially
revise several other radionuclides to move the name of the element and its atomic number
(shown in the second column of each table) to the first instance of that element alphabetically in
the tables.
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 there would be inconsistent regulations for domestic transport. 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 under DOT regulations. But if the NRC does not have
one of the radionuclides in Table A-1, then a licensee would 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 would revise Tables A-1 and A-2 in Appendix A to 10 CFR Part 71 to add seven
radionuclides (135mBa, 69Ge, 193mIr, 57Ni, 83Sr, 149Tb and 161Tb) to ensure consistent domestic
regulations for transport of radioactive material. This would 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 who use Type B packages for shipping
radioactive materials, other than for industrial radiography operations, or have licensees that
ship using the general license in § 71.21, § 71.22 or § 71.23, which also requires an approved
QAP. This would give 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 § 71.21, § 71.22 or § 71.23.
The NRC is considering 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 NRC if a package is found to have a defect or significant reduction in effectiveness so
17

that others using the package can be made aware of the situation. The NRC is proposing to
revise the compatibility category for 10 CFR 71.95(b), to Compatibility Category C, so that
Agreement States would 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, NRC is proposing to revise them to Compatibility Category C, so that the reports sent to
the Agreement States and NRC contain the same information.
Alternative 1: No-Action Alternative
Under the no-action alternative, the Agreement States would 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 § 71.21, § 71.22 or § 71.23. This has potential health and safety
consequences. For example, if the 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 would 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 would not be required to send reports required by 10
CFR 71.95(a) to the NRC of instances in which a package is found to have a defect or
significant reduction in effectiveness. The NRC would 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 would not receive reports
required by 71.95(b) of instances in which their licensees used an NRC-approved package in a
manner that does not comply with the NRC certificate of compliance. This would not give
Agreement State regulators feedback on the effectiveness of QAPs that it approves for its
licensees.
Alternative 2: Revise 10 CFR Part 71
The NRC would revise the Agreement State compatibility categories and State licensees would
be required 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 would 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 would revise the compatibility category for
71.95(b) from a Compatibility Category D to a C so that Agreement State regulators would be
able to evaluate the effectiveness of QAPs it approves for its licensees since it would receive
reports required by 71.95(b) of instances in which their licensees used an NRC-approved
package in a manner that does not comply with the NRC certificate of compliance.
In addition, Agreement States would be able to approve and inspect those shipments against all
the applicable QA requirements and perform enforcement actions, as necessary.

18

3.3.15.5

Issue 15.5–Address Redundancies in Advance Notification Requirements of 10
CFR 71.97 with Requirements of 10 CFR Parts 37 and 73.

The NRC is proposing to modify 10 CFR 71.97 to remove references to irradiated reactor fuel to
delete duplicative reporting requirements between it and 10 CFR 73.37 or 37.35, depending on
the quantity of spent fuel being transported.
Alternative 1: No-Action Alternative
Under the no-action alternative, the NRC would not delete the requirements in 10 CFR 71.97.
NRC licensees would 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 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 would revise 10 CFR 71.97 to remove the requirement for advance notification of
shipment of irradiated reactor fuel but would 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, RG 7.9, “Standard Format and Content of 10 CFR Part 71
Applications for Approval of Packages for Radioactive Material,” will be updated to make
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 would no longer be required if a revision to 10 CFR Part 71 is
implemented. Averted costs are considered as benefits (savings) and they 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 they are assigned negative values (in parentheses). The
net present value (NPV) is the discounted normal and averted cost estimates in 2020 dollars.
The following is a summary of the implementation and operational costs to industry (licensees
and CoC holders), the NRC, and the Agreement States.
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

19

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 proposed guidance or regulation changes.
Activities currently performed but which would 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 in 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
NRC's 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 would 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 or 71.21-71.23)
other than industrial radiography.

•

The average hourly rate range for a State employee is $101/hour ($32 to $161 range).

•

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

Agreement State Operation. The NRC determined that there are operational costs incurred by
the Agreement States as a result of the proposed rule as shown in Section 4.2.15.4.

4.2

Evaluation of Alternative 2 (NRC Transportation Regulations)

Tabulated cost estimates for the NRC, industry and Agreement States are provided in the tables
beginning in Section 4.2.1 by respective issue. For estimating purposes, the three input values
were used in the Monte Carlo sensitivity analysis and yielded the results shown. The following
subsections describe how the costs were developed for each issue.
4.2.1
4.2.1.1

Revision of Fissile Exemptions
Add Fissile Exemption for Packages Containing 3.5 Grams 235U per Package

If this change is adopted, it would represent a new option under the fissile exemption provisions
in 10 CFR 71.15. Consignors who 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
20

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 where 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 would
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 would 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 there are six uranium fuel fabrication plant licensees and five enrichment plant
licensees that would be expected to make shipments under this provision. Each affected
licensee would be expected to make a low number of shipments under this provision, from
several to dozens per year. This provision could also affect several 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.
Table 1
Year

a
b

Estimated Averted Cost of Making Shipments with New Fissile Exemption
Description

Number of
affected fissile
material licensees

Number of
shipments
per year

Cost per
shipment

Net Benefits (Cost) [2020$] a b

Undiscounted
7% NPV
Averted cost to ship
2022
20
23
$1,083
$487,500
$425,801
under this exemption
Averted cost to ship
2023
20
23
$1,083
$487,500
$397,945
under this exemption
Averted cost to ship
2024
20
23
$1,083
$487,500
$371,911
under this exemption
Averted cost to ship
2025
20
23
$1,083
$487,500
$347,581
under this exemption
Averted cost to ship
2026
20
23
$1,083
$487,500
$324,842
under this exemption
Averted cost to ship
2027
20
23
$1,083
$487,500
$303,590
under this exemption
Averted cost to ship
2028
20
23
$1,083
$487,500
$283,729
under this exemption
Averted cost to ship
2029
20
23
$1,083
$487,500
$265,168
under this exemption
Averted cost to ship
2030
20
23
$1,083
$487,500
$247,820
under this exemption
Averted cost to ship
2031
20
23
$1,083
$487,500
$231,608
under this exemption
Averted cost to ship
2032
20
23
$1,083
$487,500
$216,456
under this exemption
Total Benefit (Cost)
$5,362,500 $3,416,452
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

4.2.1.2

3% NPV
$459,516
$446,132
$433,137
$420,522
$408,274
$396,382
$384,837
$373,628
$362,746
$352,180
$341,923
$4,379,276

Up to 140 Grams Fissile Nuclides, Shipped Exclusive Use

This change would provide a new option under the fissile exemption provisions in 10 CFR
71.15. Licensees who wish to ship up to 140 grams (g) 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 71.23, or transport all 140 grams in an NRC-certified
21

Type AF or a B(U)F/B(M)F package. This new option would 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 would not have
to perform, and the NRC would not have to evaluate, a criticality safety evaluation per 10 CFR
71.55 and 71.59.
For 233U and plutonium shipments, 140 grams of fissile material would 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 this cost
savings would be small for such a small quantity of fissile material, for which subcriticality would
be easy to demonstrate in a certificate application. The averted cost in this case would be 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 per
10 CFR 71.55 and 71.59. The staff estimates that a demonstration of criticality safety to support
certification of this amount of material would take 87 hours on average, at an average averted
cost of $203 per hour as shown in Table 2.
Table 2
Year

Averted Cost to Licensees Using New 140 Gram Fissile Exemption
Description

No. of
Exemptions

No. of
Hours

Hourly
Cost

Net Benefits (Cost) [2020$] a b

Undiscounted
7% NPV
Averted cost to prepare
2022
0.09
87
$203
$1,602
$1,399
and submit an application
Averted cost to prepare
$203
2023
0.09
87
$1,602
$1,308
and submit an application
Averted cost to prepare
$203
2024
0.09
87
$1,602
$1,222
and submit an application
Averted cost to prepare
$203
2025
0.09
87
$1,602
$1,142
and submit an application
Averted cost to prepare
$203
2026
0.09
87
$1,602
$1,067
and submit an application
Averted cost to prepare
$203
2027
0.09
87
$1,602
$998
and submit an application
Averted cost to prepare
$203
2028
0.09
87
$1,602
$932
and submit an application
Averted cost to prepare
$203
2029
0.09
87
$1,602
$871
and submit an application
Averted cost to prepare
$203
2030
0.09
87
$1,602
$814
and submit an application
Averted cost to prepare
$203
2031
0.09
87
$1,602
$761
and submit an application
Averted cost to prepare
$203
2032
0.09
87
$1,602
$711
and submit an application
Total
1.00
$17,622
$11,227
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 between tables due to rounding.

3% NPV
$1,510
$1,466
$1,423
$1,382
$1,342
$1,303
$1,265
$1,228
$1,192
$1,157
$1,124
$14,391

The NRC modeled this as a one-time action over the 11-year cycle. The staff estimates that
NRC review of an applicant’s criticality safety demonstration would take approximately 40 hours
on average, at an average averted cost of $131 per hour as shown in Table 3.

22

Table 3
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
a
b

Averted NRC Review Cost for 140 Gram Fissile Exemption
Description
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs
NRC Operational
Averted Costs

No. of NRC Review
of Exemptions per
Year

Hours to
Review
Exemptions

Hourly
Rate

Undiscounted

7% NPV

3% NPV

0.09

43

$131

$508

$444

$479

0.09

43

$131

$508

$415

$465

0.09

43

$131

$508

$388

$451

0.09

43

$131

$508

$362

$438

0.09

43

$131

$508

$339

$426

0.09

43

$131

$508

$316

$413

0.09

43

$131

$508

$296

$401

0.09

43

$131

$508

$276

$389

0.09

43

$131

$508

$258

$378

0.09

43

$131

$508

$241

$367

0.09

43

$131

$508

$226

$356

Net Benefits (Cost) [2020$] a b

$5,589
$3,561
Total
1.00
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

$4,565

The affected licensees consist primarily of enrichment and fuel fabrication facilities and reactor
facilities undergoing decommissioning. Currently there are six uranium fuel fabrication plant
licensees, five enrichment plant licensees, and 18 reactor units undergoing decommissioning
that would be expected to make shipments under the proposed 140-gram limitation. Under this
proposal, each affected licensee would be expected to make a low number of shipments from
several to dozens per year. This provision could also affect several U.S. DOE facilities, but
these effects are not being considered for this impact assessment because DOE does not utilize
NRC regulations for shipments between its facilities. Under DOT regulations, DOE self-certifies
shipments between its facilities. For cost analysis considerations, the staff estimates an average
of 11 shipments per year that would 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
Number of
Licensees

Number of
Shipments

Licensee averted shipping
cost under this exemption

30

11

2023

Licensee averted shipping
cost under this exemption

30

2024

Licensee averted shipping
cost under this exemption

2025
2026

Year

Description

2022

Cost per
Shipment

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

$108

$35,208

$30,752

$33,187

11

$108

$35,208

$28,740

$32,221

30

11

$108

$35,208

$26,860

$31,282

Licensee averted shipping
cost under this exemption

30

11

$108

$35,208

$25,103

$30,371

Licensee averted shipping
cost under this exemption

30

11

$108

$35,208

$23,461

$29,486

23

Number of
Licensees

Number of
Shipments

Licensee averted shipping
cost under this exemption

30

11

2028

Licensee averted shipping
cost under this exemption

30

2029

Licensee averted shipping
cost under this exemption

2030

Year

Description

2027

Cost per
Shipment

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

$108

$35,208

$21,926

$28,628

11

$108

$35,208

$20,492

$27,794

30

11

$108

$35,208

$19,151

$26,984

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

$387,292
$246,744
Total
121
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

$316,281

a
b

4.2.2

Revision of Reduced External Pressure Test for Normal Conditions of Transport

The NRC has decided not to further 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
4.2.4.1

Revision of Insolation Requirements for Package Evaluations
Cost Impacts for 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 certificate to show they meet the
revised NRC requirements in the first 4 years after the rule change to ensure the packages are
approved within the 8-year timeframe for package phaseout. In addition, the staff estimates that
certificate holders will revise an additional four certificates of compliance 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
4 years of the rulemaking and another four 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 would 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
would 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

24

waste packages), the certificate holders would 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 would 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 the table below.
Table 5

Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032

Cost for Certificate Holders to Prepare an Application Evaluating New Insolation
Value
Description

Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation
Cost to submit certificate
for new insolation

No. of
Certificates
Revision

Certification
Request
Preparation
Cost

7.5

Net Benefit (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

($8,667)

($65,000)

($56,774)

($61,269)

7.5

($8,667)

($65,000)

($53,059)

($59,484)

7.5

($8,667)

($65,000)

($49,588)

($57,752)

7.5

($8,667)

($65,000)

($46,344)

($56,070)

4

($8,667)

($34,667)

($23,100)

($29,033)

4

($8,667)

($34,667)

($21,589)

($28,187)

4

($8,667)

($34,667)

($20,176)

($27,366)

4

($8,667)

($34,667)

($18,856)

($26,569)

4

($8,667)

($34,667)

($17,623)

($25,795)

4

($8,667)

($34,667)

($16,470)

($25,044)

4

($8,667)

($34,667)

($15,392)

($24,315)

Total
58
($502,667)
($338,971)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
b
There may be differences between tables due to rounding.

($420,883)

a

The staff estimates that time required to review these applications would vary depending on the
complexity of the package. The staff estimates that the time required to review an update to the
value for insolation would range from a low of 5 hours to a maximum of 24 hours, with the most
likely review time of 15 hours. Table 6 shows that the estimated review cost is ($76,000) using a
7-percent discount rate and ($94,000) using a 3-percent discount rate.
Table 6

NRC Cost to Review Applications for Revised Certificates of Compliance

NRC review costs

Number of
Revised
Certificates
7.5

Number of
Review
Hours
15

2023

NRC review costs

7.5

2024

NRC review costs

2025

NRC review costs

2026

Net Benefit (Cost) [2020$] a b

Labor
Rate

Undiscounted

7% NPV

3% NPV

$131

($14,574)

($12,729)

($13,737)

15

$131

($14,574)

($11,897)

($13,337)

7.5

15

$131

($14,574)

($11,118)

($12,949)

7.5

15

$131

($14,574)

($10,391)

($12,571)

NRC review costs

4.0

15

$131

($7,773)

($5,179)

($6,509)

2027

NRC review costs

4.0

15

$131

($7,773)

($4,840)

($6,320)

2028

NRC review costs

4.0

15

$131

($7,773)

($4,524)

($6,136)

2029

NRC review costs

4.0

15

$131

($7,773)

($4,228)

($5,957)

Year

Description

2022

25

a
b

NRC review costs

Number of
Revised
Certificates
4.0

Number of
Review
Hours
15

2031

NRC review costs

4.0

2032

NRC review costs

4.0

Net Benefit (Cost) [2020$] a b

Labor
Rate

Undiscounted

7% NPV

3% NPV

$131

($7,773)

($3,951)

($5,784)

15

$131

($7,773)

($3,693)

($5,615)

15

$131

($7,773)

($3,451)

($5,452)

Total
58
($112,704)
($76,001)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

($94,367)

Year

Description

2030

Impact to Applicants for a New Certificate of Compliance
For new certificates of compliance there would be a small additional accrued cost because of
this rulemaking. Although applicants for a CoC already are 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 would be approximately $500.
Larger, more complex packages (i.e., spent fuel and Type B waste packages) would require
more complex computer modeling, so that the NRC review cost would 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 submitted for review and approval. The staff estimates that the averted
cost for this review would be approximately $1,000 per package.
Table 7
Year

Licensee Averted Costs to Submit Certificate for New Certificate of Compliance
Description

Number of
New
Certificates

Certification
Request
Preparation Cost

Net Benefits (Cost) [2020$] a b

Undiscounted
7% NPV
Averted cost to submit certificate
2022
$1,083
$1,083
$946
1
for new certificate of compliance
Averted cost to submit certificate
2023
$1,083
$1,083
$884
1
for new certificate of compliance
Averted cost to submit certificate
2024
$1,083
$1,083
$826
1
for new certificate of compliance
Averted cost to submit certificate
2025
$1,083
$1,083
$772
1
for new certificate of compliance
Averted cost to submit certificate
2026
$1,083
$1,083
$722
1
for new certificate of compliance
Averted cost to submit certificate
2027
$1,083
$1,083
$675
1
for new certificate of compliance
Averted cost to submit certificate
2028
$1,083
$1,083
$631
1
for new certificate of compliance
Averted cost to submit certificate
2029
$1,083
$1,083
$589
1
for new certificate of compliance
Averted cost to submit certificate
2030
$1,083
$1,083
$551
1
for new certificate of compliance
Averted cost to submit certificate
2031
$1,083
$1,083
$515
1
for new certificate of compliance
Averted cost to submit certificate
2032
$1,083
$1,083
$481
1
for new certificate of compliance
$11,917
$7,592
Total
11
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 between tables due to rounding.

3% NPV
$1,021
$991
$963
$934
$907
$881
$855
$830
$806
$783
$760
$9,732

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 would
be approximately 3 hours for small packages, 10 hours for large, complex packages and, on
average, approximately 5.5 hours.

26

Table 8

NRC Incremental Costs to Review New Certificates of Compliance

NRC costs to review submitted certificates

No. of New
Certificate
Submittals
1.0

No. of
Review
Hours
(5.5)

2023

NRC costs to review submitted certificates

1.0

2024

NRC costs to review submitted certificates

1.0

2025

NRC costs to review submitted certificates

2026
2027

Net Benefits (Cost) [2020$] a b

Labor
Rate

Undiscounted

7% NPV

3% NPV

$131

($721)

($629)

($679)

(5.5)

$131

($721)

($588)

($659)

(5.5)

$131

($721)

($550)

($640)

1.0

(5.5)

$131

($721)

($514)

($622)

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($480)

($603)

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($449)

($586)

2028

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($419)

($569)

2029

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($392)

($552)

2030

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($366)

($536)

2031

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($342)

($521)

2032

NRC costs to review submitted certificates

1.0

(5.5)

$131

($721)

($320)

Year

Description

2022

a
b

($7,926)
($5,049)
Total
11.0
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

($505)
($6,472)

Table 8 estimates that the incremental NRC review costs are $5,000 using a 7-percent discount
rate and $6,500 using a 3-percent discount rate.
4.2.4.2

Cost Impacts for Insolation for Hypothetical Accident Conditions

Cost Impact to Existing Certificate Holders
Similar to the cost for impacts of insolation for normal conditions of transport, above, the cost to
an existing certificate holder to evaluate the insolation as an initial condition to the fire test would
vary depending on the complexity of the thermal evaluation. Some smaller packages with
significant margin may use reasoned argument to evaluate the revised initial condition, whereas
larger, more complex packages (i.e., spent fuel and Type B waste packages) would 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 would 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 would be approximately $20,000, assuming more than one analysis must be
reevaluated. The staff estimates that all 14 certificate holders would revise 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 revise an average of 7.5 certificates per year over the 11year 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. Since NRC
expects on average 7.5 applications each year for the first four years after the rule change and

27

4 applications for years 5 to 11, the undiscounted cost to certificate holders would total to
$655,000 for years 2022 to 2025 and costs of $611,331 for years 2026 to 2032 for a total cost of
$1,266,333.
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$] a b
Undiscounted

7% NPV

Cost to evaluate insolation
2022
7.5
($21,833)
($163,750)
($143,026)
as an initial condition
Cost to evaluate insolation
2023
7.5
($21,833)
($163,750)
($133,669)
as an initial condition
Cost to evaluate insolation
2024
7.5
($21,833)
($163,750)
($124,924)
as an initial condition
Cost to evaluate insolation
2025
7.5
($21,833)
($163,750)
($116,751)
as an initial condition
Cost to evaluate insolation
2026
4
($21,833)
($87,333)
($58,194)
as subsequent condition
Cost to evaluate insolation
2027
4
($21,833)
($87,333)
($54,387)
as subsequent condition
Cost to evaluate insolation
2028
4
($21,833)
($87,333)
($50,829)
as subsequent condition
Cost to evaluate insolation
2029
4
($21,833)
($87,333)
($47,504)
as subsequent condition
Cost to evaluate insolation
2030
4
($21,833)
($87,333)
($44,396)
as subsequent condition
Cost to evaluate insolation
2031
4
($21,833)
($87,333)
($41,491)
as subsequent condition
Cost to evaluate insolation
2032
4
($21,833)
($87,333)
($38,777)
as subsequent condition
($1,266,333)
($853,947)
Total
83
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 between tables due to rounding.

3% NPV
($154,350)
($149,854)
($145,490)
($141,252)
($73,140)
($71.010)
($68,942)
($66.934)
($64,984)
($63,081)
($61,254)
($1,060,302)

The staff estimates that time required to review these applications would vary depending on the
complexity of the package. The staff estimates that the time required to review an update to the
value for insolation would range from a low of 5 hours to a maximum of 24 hours, with the most
likely review time of 15 hours.
Table 10
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030

NRC Cost to Review Applications for Revised Certificates of Compliance

Description
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates
NRC review of revised
certificates

No. of
Certificates
Submitted

Hours to
Review
Applications

Labor
Rate

Undiscounted

7% NPV

3% NPV

7.5

(15)

$131

($14,574)

($12,729)

($13,737)

7.5

(15)

$131

($14,574)

($11,897)

($13,337)

7.5

(15)

$131

($14,574)

($11,118)

($12,949)

7.5

(15)

$131

($14,574)

($10,391)

($12,571)

4

(15)

$131

($7,773)

($5,179)

($6,509)

4

(15)

$131

($7,773)

($4,840)

($6,320)

4

(15)

$131

($7,773)

($4,524)

($6,136)

4

(15)

$131

($7,773)

($4,228)

($5,957)

4

(15)

$131

($7,773)

($3,951)

($5,784)

28

Net Benefits (Cost) [2020$] a b

Year
2031
2032
a
b

Description

No. of
Certificates
Submitted

NRC review of revised
certificates
NRC review of revised
certificates

Hours to
Review
Applications

Labor
Rate

Undiscounted

7% NPV

3% NPV

4

(15)

$131

($7,773)

($3,693)

($5,615)

4

(15)

$131

($7,773)

($3,451)

($5,452)

Net Benefits (Cost) [2020$] a b

Total
58
($112,704)
($76,001)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

($94,367)

Cost Impact to Applicants for a New Certificate of Compliance
The staff estimates that there would be an additional accrued cost for new certificates of
compliance. 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(b) would increase the applicant’s 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 would 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) would require more complex computer modeling,
therefore the increased cost would be approximately $30,000 per package for an applicant to
prepare and submit an application. The high estimate is for the package or two which has
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 would be
approximately $6,500.
Table 11

Year

Licensee Costs to Submit Certificate for New Certificate of Compliance

Description

No. of
Applications
per Year

Cost to
Prepare and
Submit
Certification
Request

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

Licensee costs to prepare and
1
($6,500)
($6,500)
($5,677)
submit revised certificates
Licensee costs to prepare and
2023
1
($6,500)
($6,500)
($5,306)
submit revised certificates
Licensee costs to prepare and
2024
1
($6,500)
($6,500)
($4,959)
submit revised certificates
Licensee costs to prepare and
2025
1
($6,500)
($6,500)
($4,634)
submit revised certificates
Licensee costs to prepare and
2026
1
($6,500)
($6,500)
($4,331)
submit revised certificates
Licensee costs to prepare and
2027
1
($6,500)
($6,500)
($4,048)
submit revised certificates
Licensee costs to prepare and
2028
1
($6,500)
($6,500)
($3,783)
submit revised certificates
Licensee costs to prepare and
2029
1
($6,500)
($6,500)
($3,536)
submit revised certificates
Licensee costs to prepare and
2030
1
($6,500)
($6,500)
($3,304)
submit revised certificates
Licensee costs to prepare and
2031
1
($6,500)
($6,500)
($3,088)
submit revised certificates
Licensee costs to prepare and
2032
1
($6,500)
($6,500)
($2,886)
submit revised certificates
($71,500)
($45,553)
Total
11
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 between tables due to rounding.
2022

29

3% NPV
($6,127)
($5,948)
($5,775)
($5,607)
($5,444)
($5,285)
($5,131)
($4,982)
($4,837)
($4,696)
($4,559)
($58,390)

The staff estimates that it will receive one new package per year, over the 11-year period
following the final rule effective date. The staff estimates that its review cost to evaluate these
submittals would depend on the package type and how the applicant evaluated the package for
the fire test. The staff estimates that, for smaller packages, the time needed to perform the
application review and to document the review in a safety evaluation report would take
approximately 3 hours and larger, more complex package design reviews would take
approximately 30 hours. The staff estimates that the average review time for this change would
be 12 hours.
Table 12
Year

a
b

NRC Incremental Costs to Review New Certificates of Compliance
Description

No. of New
Certificates

No. of Hours
to Review
New
Application

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

NRC costs to review new
2022
1
(12)
$131
($1,594)
($1,392)
certificate of compliance
NRC costs to review new
2023
1
(12)
$131
($1,594)
($1,301)
certificate of compliance
NRC costs to review new
2024
1
(12)
$131
($1,594)
($1,216)
certificate of compliance
NRC costs to review new
2025
1
(12)
$131
($1,594)
($1,136)
certificate of compliance
NRC costs to review new
2026
1
(12)
$131
($1,594)
($1,062)
certificate of compliance
NRC costs to review new
2027
1
(12)
$131
($1,594)
($993)
certificate of compliance
NRC costs to review new
2028
1
(12)
$131
($1,594)
($928)
certificate of compliance
NRC costs to review new
2029
1
(12)
$131
($1,594)
($867)
certificate of compliance
NRC costs to review new
2030
1
(12)
$131
($1,594)
($810)
certificate of compliance
NRC costs to review new
2031
1
(12)
$131
($1,594)
($757)
certificate of compliance
NRC costs to review new
2032
1
(12)
$131
($1,594)
($708)
certificate of compliance
($17,533)
($11,170)
Total
11
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

4.2.5

3% NPV
($1,502)
($1,459)
($1,416)
($1,375)
($1,335)
($1,296)
($1,258)
($1,222)
($1,186)
($1,151)
($1,118)
($14,318)

Inclusion of Definition for Radiation Level

For cost analysis considerations, the staff estimates that no licensees would 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 would be an averted cost impact of this proposed change to licensees
or CoC holders because removing the leaching test requirement would provide regulatory relief.
The test would be removed from 10 CFR 71.77 and would 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 would be $21,667,
with a minimum test cost of $10,000, a most likely cost of $20,000, and the maximum test cost
of $40,000. The total averted cost over the 11 years following the rulemaking is $73,106, using
a 7-percent discount factor.

30

Table 13
Year

2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
a
b

Averted Cost for Deletion of Leaching Test
Description
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test
Licensee preparation to assess
impact of Deletion of the Low
Specific Activity-III Leaching Test

No. of Low
Specific
Activity-III
Leaching Tests

Cost for Low
Specific
Activity-III
Leaching Test

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

0.45

$21,667

$9,848

$8,602

$9,283

0.45

$21,667

$9,848

$8,039

$9,013

0.45

$21,667

$9,848

$7,513

$8,750

0.45

$21,667

$9,848

$7,022

$8,495

0.45

$21,667

$9,848

$6,562

$8,248

0.45

$21,667

$9,848

$6,133

$8,008

0.45

$21,667

$9,848

$5,732

$7,774

0.45

$21,667

$9,848

$5,357

$7,548

0.45

$21,667

$9,848

$5,006

$7,328

0.45

$21,667

$9,848

$4,679

$7,115

0.45

$21,667

$9,848

$4,373

$6,908

Total Benefit (Cost)
$118,182
$73,106
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

4.2.7

$95,177

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 proposed new SCO-III material would 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 hours. The NRC estimates that the time required to review these packages
could range from 200 hours to 600 hours. 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 $573,000, using a
7-percent discount rate.

31

Table 14
Year
2022

Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III
Licensee assessment of
material to qualify as SCO-III

No. of
Licensees that
Apply New
Definition

Hours To
Perform a
SCO-III
Assessment

Net Benefits (Cost) [2020$] a b

Cost to
Prepare
Application

Undiscounted

7% NPV

3% NPV

1

$50,000

$81,818

$62,419

$72,694

1.6

1

$50,000

$81,818

$58,335

$70,577

1.6

1

$50,000

$81,818

$54,519

$68,521

1.6

1

$50,000

$81,818

$50,952

$66,526

1.6

1

$50,000

$81,818

$47,619

$64,588

1.6

1

$50,000

$81,818

$44,504

$62,707

1.6

1

$50,000

$81,818

$41,592

$60,880

1.6

1

$50,000

$81,818

$38,871

$59,107

1.6

1

$50,000

$81,818

$36,328

$57,386

1.6

1

$50,000

$81,818

$71,463

$77,121

1.6

1

$50,000

$81,818

$66,788

$74,875

Total Benefit (Cost)
$900,000
$573,391
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

$734,983

2024
2025
2026
2027
2028
2029
2030
2031
2032

b

Description

1.6

2023

a

Averted Cost for Licensees using SCO-III Package

Table 15 shows the averted cost to the NRC for the 11 years is $601,000, based on a 7-percent
discount rate.
Table 15

No. of
Decommissioned
Power Plants That
Apply New
Definition

No. of Hours
to Review
and Issue an
Exemption
Request

1.6

400

$131

$85,745

$74,893

$80,823

1.6

400

$131

$85,745

$69,994

$78,469

1.6

400

$131

$85,745

$65,415

$76,184

1.6

400

$131

$85,745

$61,135

$73,965

1.6

400

$131

$85,745

$57,136

$71,810

1.6

400

$131

$85,745

$53,398

$69,719

1.6

400

$131

$85,745

$49,905

$67,688

1.6

400

$131

$85,745

$46,640

$65,717

1.6

400

$131

$85,745

$43,589

$63,803

1.6

400

$131

$85,745

$40,737

$61,944

1.6

400

$131

$85,745

$38,072

$60,140

Total Benefit (Cost)
$943,200
$600,913
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

$770,263

Year

2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
a
b

Averted Cost for NRC Review for Licensees using SCO-III
Description
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation
NRC harmonize with
DOT regulation

32

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

4.2.8

Revision of Uranium Hexafluoride Package Requirements

Currently the NRC has two certificates of compliance to transport UF6 in 30B cylinders, one of
which has already shown that the plug meets the requirements in SSR-6, 2018 Edition. If the
certificate holder desires to revise the CoC to the new NRC requirements harmonized with
SSR-6, 2018 Edition, then the certificate holder would have to demonstrate that the cylinder
plug remains leaktight after the tests for hypothetical accident conditions listed in 10 CFR 71.73
and doesn’t contact any other part of the package other than at its point of attachment to the
cylinder. The NRC estimates the cost to the existing certificate holder to evaluate the change
would depend on the currently available information to the certificate holder. The NRC estimates
that if existing drop tests or analyses could be used to demonstrate compliance with the
proposed regulations, the cost to compile and submit an application to the NRC would be
$50,000. However, if the applicant cannot use existing data, and would 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). This cost would
be a single, one-time cost to the current certificate holder; however, it is unclear to the NRC in
which year to include this one-time cost. Therefore, the NRC has averaged the cost over each
of the 11 years following the rulemaking.
Table 16
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031

Cost to Prepare Application for Revised UF6 Certificate of Compliance
Description
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs
Number of certificates to
be revised to current
(2018) IAEA regs

Cost to Prepare and
Submit Certification
Request

Undiscounted

7% NPV

3% NPV

0.09

($108,333)

($9,848)

($8,602)

($9,283)

0.09

($108,333)

($9,848)

($8,039)

($9,013)

0.09

($108,333)

($9,848)

($7,513)

($8,750)

0.09

($108,333)

($9,848)

($7,022)

($8,495)

0.09

($108,333)

($9,848)

($6,562)

($8,248)

0.09

($108,333)

($9,848)

($6,133)

($8,008)

0.09

($108,333)

($9,848)

($5,732)

($7,774)

0.09

($108,333)

($9,848)

($5,357)

($7,548)

0.09

($108,333)

($9,848)

($5,006)

($7,328)

0.09

($108,333)

($9,848)

($4,679)

($7,115)

No. of
Certificates

33

Net Benefits (Cost) [2020$] a b

Year

a
b

Description

No. of
Certificates

Cost to Prepare and
Submit Certification
Request

Net Benefits (Cost) [2020$] a b

Undiscounted
7% NPV
Number of certificates to
0.09
($108,333)
($9,848)
($4,373)
2032
be revised to current
(2018) IAEA regs
Total
1.00
($108,333)
($69,019)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

3% NPV
($6,908)
($88,470)

The NRC estimates that the cost to the NRC to perform the review would 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, the NRC
review would take approximately 158 hours to review one certificate, which the staff expects to
be submitted within the 11-year period analysis period.
Table 17
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
a
b

NRC Cost to Review Application for Certificate Revision

Description

No. of Certificates
Revised to 2018
IAEA Standards

No. of Hours
to Review
Application

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b

Undiscounted
7% NPV
NRC review of
0.09
(158)
$131
($1,887)
($1,648)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,540)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,439)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,345)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,257)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,175)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,098)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($1,026)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($959)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($896)
revised certificates
NRC review of
0.09
(158)
$131
($1,887)
($838)
revised certificates
($20,753) ($13,221)
Total
1.00
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

3% NPV
($1,778)
($1,727)
($1,676)
($1,627)
($1,580)
($1,534)
($1,489)
($1,446)
($1,404)
($1,363)
($1,323)
($16,948)

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 would 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 would be $25,000.

34

The NRC estimates that its cost to review and document the soundness of the cylinder plug
after the tests for hypothetical accident conditions would be 50 hours for a cost of $6,500, if the
applicant evaluated the plug by drop tests, and 250 hours 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 proposed changes to the packaging requirements to add evaluation of aging effects and a
maintenance program would not impact the applications for transport of package design
approval or NRC reviews. These changes ensure consistency with IAEA standards and conform
to approaches already taken by certificate holders to evaluate aging effects and inclusion of a
maintenance program. Consequently, no changes to packages or costs—for either the NRC or
current or future certificate holders—are anticipated from implementing this change to the
regulation.
4.2.10 Revision of Transitional Arrangements
After the effective date of the rulemaking, the change would 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 would have fewer costs to recertify than packages that cannot be shown to meet
current safety regulations. In general, the types of costs industry would 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 and/or
physically test 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 NRC 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
whose certificate is based on the NRC regulations harmonized with SS 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 NRC estimated 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, would 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 average cost would 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 prior to 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 would revise an additional four
certificates per year to SSR-6, 2018 Edition of IAEA standards. Therefore, certificate holders
would revise an average of 7.5 certificates per year, for the first 4 years and 4 certificates per
year for the next 7 years following the final rule effective date to show compliance with the NRC
regulations in effect at the time.

35

Table 18
Year

a
b

Description

Year

2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032

b

Number of
Revised
Certificates

Cost to Prepare and
Submit Certification
Request

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

Licensee preparation of
2022
7.5
($20,000)
($150,000)
($131,016)
revised certificates
Licensee preparation of
2023
7.5
($20,000)
($150,000)
($122,445)
revised certificates
Licensee preparation of
2024
7.5
($20,000)
($150,000)
($114,434)
revised certificates
Licensee preparation of
2025
7.5
($20,000)
($150,000)
($106,948)
revised certificates
Licensee preparation of
2026
4
($20,000)
($80,000)
($53,307)
revised certificates
Licensee preparation of
2027
4
($20,000)
($80,000)
($49,820)
revised certificates
Licensee preparation of
2028
4
($20,000)
($80,000)
($46,561)
revised certificates
Licensee preparation of
2029
4
($20,000)
($80,000)
($43,515)
revised certificates
Licensee preparation of
2030
4
($20,000)
($80,000)
($40,668)
revised certificates
Licensee preparation of
2031
4
($20,000)
($80,000)
($38,007)
revised certificates
Licensee preparation of
2032
4
($20,000)
($80,000)
($35,521)
revised certificates
($1,160,000)
($782,242)
Total
58.0
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

Table 19

a

Certificate Holder Cost to Revise Certificates

3% NPV
($141,389)
($137,271)
($133,273)
($129,391)
($66,999)
($65,047)
($63,153)
($61,313)
($59,528)
($57,794)
($56,110)
($971,269)

NRC Review Time for Revised Certificates Cost

Description

NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost
NRC review certificate
revision cost

No. of
Certificates
Revised to
2018 IAEA
Standards

No. of
Hours to
Review
Licensee
Report

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

7.5

130

($131)

($127,725)

($111,560)

($120,393)

7.5

130

($131)

($127,725)

($104,262)

($116,886)

7.5

130

($131)

($127,725)

($97,441)

($113,482)

7.5

130

($131)

($127,725)

($91,066)

($110,177)

4

130

($131)

($68,120)

($45,391)

($57,049)

4

130

($131)

($68,120)

($42,422)

($55,388)

4

130

($131)

($68,120)

($39,646)

($53,775)

4

130

($131)

($68,120)

($37,053)

($52,208)

4

130

($131)

($68,120)

($34,629)

($50,688)

4

130

($131)

($68,120)

($32,363)

($49,211)

4

130

($131)

($68,120)

($30,246)

($47,778)

Total
58.0
($987,740)
($666,079)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

36

($827,035)

If a package design that does not have a “-85” or “-96” in its package identification number
cannot be shown to meet current safety standards, the NRC estimated the cost to design,
receive NRC certification, and fabricate a replacement package. This estimate is based on
updating the similar information in NUREG/CR-6713, “Regulatory Analysis of Major Revision of
10 CFR Part 71,” Section 3.3.8, “Grandfathering of Previously Approved Packages” [31]. The
staff’s estimates for the cost to design, obtain NRC approval, and fabricate new packages
ranges between $387,612 and $893,967 with an average cost of $597,500.
Table 20
Year

a
b

Certificate Holder Cost to Prepare an Application for a Replacement Package
Description

No. of Certificates
Revised to 2018
IAEA Standards

Cost to Prepare
and Submit
Certification
Request

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

Licensee cost to prepare
2022
0.2
($597,500)
($119,500)
($104,376)
an application
Licensee cost to prepare
2023
0.2
($597,500)
($119,500)
($97,548)
an application
Licensee cost to prepare
2024
0.2
($597,500)
($119,500)
($91,166)
an application
Licensee cost to prepare
2025
0.2
($597,500)
($119,500)
($85,202)
an application
Licensee cost to prepare
2026
0.2
($597,500)
($119,500)
($79,628)
an application
Licensee cost to prepare
2027
0
($0)
($0)
($0)
an application
Licensee cost to prepare
2028
0
($0)
($0)
($0)
an application
Licensee cost to prepare
2029
0
($0)
($0)
($0)
an application
Licensee cost to prepare
2030
0
($0)
($0)
($0)
an application
Licensee cost to prepare
2031
0
($0)
($0)
($0)
an application
Licensee cost to prepare
2032
0
($0)
($0)
($0)
an application
Total
1.0
($597,500)
($457,919)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

3% NPV
($112,640)
($109,359)
($106174)
($103,082)
($100,079)
($0)
($0)
($0)
($0)
($0)
($0)
($531,335)

The NRC estimates that the NRC’s cost to review these new package design applications would
take a mean of 1,056 hours per certificate. In addition, one package over a three-year period
(2027 to 2029), at $131 per staff-hour, excluding any review time for costs associated with other
changes in this rulemaking, results in a cost of ($80,634) at 7%.
Table 21
Year
2022
2023
2024
2025
2026

NRC Review Cost for Reviewing an Application for a Replacement Package
Description
NRC cost to review
new package design
NRC cost to review
new package design
NRC cost to review
new package design
NRC cost to review
new package design
NRC cost to review
new package design

No. of Certificates
Revisions to 2018
IAEA Standards

No. of Hours
to Review
Licensee
Reports

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

0

1,056

($131)

($0)

($0)

($0)

0

1,056

($131)

($0)

($0)

($0)

0

1,056

($131)

($0)

($0)

($0)

0

1,056

($131)

($0)

($0)

($0)

0

1,056

($131)

($0)

($0)

($0)

37

Year

Description

No. of Hours
to Review
Licensee
Reports

No. of Certificates
Revisions to 2018
IAEA Standards

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

NRC cost to review
0.3
1,056
($131)
($46,111)
($28,716)
new package design
NRC cost to review
2028
0.3
1,056
($131)
($46,111)
($26,837)
new package design
NRC cost to review
2029
0.3
1,056
($131)
($46,111)
($28,081)
new package design
NRC cost to review
2030
0
1,056
($131)
($0)
($0)
new package design
NRC cost to review
2031
0
1,056
($131)
($0)
($0)
new package design
NRC cost to review
2032
0
1,056
($131)
($0)
($0)
new package design
Total
1.0
Total
($138,333)
($80,634)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.
2027

a
b

3% NPV
($37,493)
($36,401)
($35,340)
($)
($0)
($)
($109,233)

4.2.11 Inclusion of Head Space for Liquid Expansion
The NRC currently has six certificates of compliance that authorize liquid contents. The NRC
estimates that, when an existing certificate holder desires to revise its certificate to the latest
version of the regulations, the certificate holder would 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 would cost the applicant approximately $1,500 per application.
Table 22

Year

2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032

Licensee Cost to Prepare and Evaluate Liquid Expansion
No. of
Certificates
Revised to
2018 IAEA
Standards

Description
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Licensee preparation of
revised certificates
Total

a
b

Cost to
Prepare and
Submit
Certification
Request

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

0.55

($1,500)

($818)

($715)

($771)

0.55

($1,500)

($818)

($668)

($749)

0.55

($1,500)

($818)

($624)

($727)

0.55

($1,500)

($818)

($583)

($706)

0.55

($1,500)

($818)

($545)

($685)

0.55

($1,500)

($818)

($510)

($665)

0.55

($1,500)

($818)

($476)

($646)

0.55

($1,500)

($818)

($445)

($627)

0.55

($1,500)

($818)

($416)

($609)

0.55

($1,500)

($818)

($389)

($591)

0.55

($1,500)

($818)

($363)

($574)

($9,000)

($5,734)

($7,350)

6.00

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

38

The NRC estimates that there would 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
the container includes sufficient head space for the liquid contents.
The NRC estimates that its review of an application for revision of an existing certificate would
take approximately 4 hours. The NRC estimates that the cost to evaluate six package
applications to revise an existing CoC to revised NRC regulations that are harmonized with
SSR-6, 2018 Edition, over an 11-year period would be $2,000 based on a 7-percent discount
rate.
Table 23

Year

NRC Cost to Evaluate Application for Liquid Expansion

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

b

Net Benefits (Cost) [2020$] a b
Undiscounted

NRC review of revised
1
(4)
$131
($286)
certificates
NRC review of revised
2023
1
(4)
$131
($286)
certificates
NRC review of revised
2024
1
(4)
$131
($286)
certificates
NRC review of revised
2025
1
(4)
$131
($286)
certificates
NRC review of revised
2026
1
(4)
$131
($286)
certificates
NRC review of revised
2027
1
(4)
$131
($286)
certificates
NRC review of revised
2028
1
(4)
$131
($286)
certificates
NRC review of revised
2029
1
(4)
$131
($286)
certificates
NRC review of revised
2030
1
(4)
$131
($286)
certificates
NRC review of revised
2031
1
(4)
$131
($286)
certificates
Total
11
($3,144)
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.
2022

a

NRC
Labor
Rate

7% NPV

3% NPV

($250)

($269)

($233)

($262)

($218)

($254)

($204)

($247)

($190)

($239)

($178)

($232)

($166)

($226)

($155)

($219)

($145)

($213)

($136)

($206)

($2,003)

($2,568)

4.2.12 Revision of Quality Assurance Program Biennial Reporting Requirements
The proposed rulemaking alternative would currently affect 41 QAP approval holders under
10 CFR Part 71. Each affected QAP approval holder would need to reconcile the change with
their own procedures and processes which would be a one-time implementation cost once the
final rule is issued. The NRC estimates that this review and update would cost on average $800
per QAP approval holder. The majority of the 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 would 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 would need to make conforming changes to their current processes to ensure a biennial
report is issued to the NRC at future reporting intervals if no changes were made to their QAP
during the previous 24 months.

39

Table 24
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
2033

a
b

Licensee Cost to Evaluate Program Change for Biennial Report
No. of
Hours to
Revise
QAP

No. of
QAPs
Clarified

Description
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP
Licensee/Certificate holder cost
to evaluate QAP

Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

(41)

10

$80

($32,800)

($28,649)

($30,917)

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

0

10

$80

$0

$0

$0

Total

($32,800)

($28,649)

($30,917)

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

In addition, the three QAP approval holders discussed above that have not submitted a biennial
report would incur the operational costs of issuing those biennial reports stating no changes
were made every 24 months. The NRC estimates that QAP approval holder operational costs
for issuance of their QAP biennial report every 24 months would be approximately 1 hour for
each issuance occurrence at a rate of $80 per hour. The NRC assumes that an additional four
QAP approval holders would need to submit a report in each future 24-month reporting interval
if no changes were made to their QAP.
Table 25
Year

2022
2023
2024
2025
2026

Licensee Cost to Submit Biennial Report
Description

Licensees and certificate
holders cost to submit
QAP biennial report
Licensees and certificate
holders cost to submit
QAP biennial report
Licensees and certificate
holders cost to submit
QAP biennial report
Licensees and certificate
holders cost to submit
QAP biennial report
Licensees and certificate
holders cost to submit
QAP biennial report

No. of QAP
Biennial
Report
Submitted

No. of Hours to
Develop and
Submit Biennial
Report

Labor Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

4

(1)

$80

($307)

($268)

($289)

0

(1)

$80

$0

$0

$0

4

(1)

$80

($307)

($234)

($272)

0

(1)

$80

$0

$0

$0

4

(1)

$80

($307)

($204)

($257)

40

Year

No. of QAP
Biennial
Report
Submitted

Description
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report
Licensees’ and
certificate holders’ cost
to submit QAP biennial
report

2027

2028

2029

2030

2031

2032

Total
a
b

No. of Hours to
Develop and
Submit Biennial
Report

Net Benefits (Cost) [2020$] a b

Labor Rate

Undiscounted

7% NPV

3% NPV

0

(1)

$80

$0

$0

$0

4

(1)

$80

($307)

($178)

($242)

0

(1)

$80

$0

$0

$0

4

(1)

$80

($307)

($156)

($228)

0

(1)

$80

$0

$0

$0

4

(1)

$80

($307)

($136)

($215)

($1,176)

($1,503)

($1,839)

24

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

The NRC estimates that its review of additional QAP biennial reports every 2 years would take
approximately 1 hour each for every review occurrence at a rate of $131 per staff-hour. The
NRC assumed four additional QAP biennial reports would be reviewed based on three QAP
approval holders who have not submitted a report as described above.
Table 26
Year
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031

NRC Cost to Review Biennial Report

Description
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals
NRC review of biennial
report submittals

No. of Biennial
Report
Submittals

No. of Hours to
Review Biennial
QAP Report

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

Net Benefits (Cost) [2020$] a b

4

(1)

$131

($502)

($438)

($473)

0

(1)

$131

$0

$0

$0

4

(1)

$131

($502)

($383)

($446)

0

(1)

$131

$0

$0

$0

4

(1)

$131

($502)

($334)

($420)

0

(1)

$131

$0

$0

$0

4

(1)

$131

($502)

($292)

($396)

0

(1)

$131

$0

$0

$0

4

(1)

$131

($502)

($255)

($373)

0

(1)

$131

$0

$0

$0

41

Year

Description

2032

NRC review of biennial
report submittals

a
b

No. of Biennial
Report
Submittals

No. of Hours to
Review Biennial
QAP Report

4

(1)

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

$131

($502)

($223)

($352)

Net Benefits (Cost) [2020$] a b

($3,012)
($1,926)
Total
24
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

($2,461)

4.2.13 Deletion of Type A Package Limitations in Fissile Material General Licenses
The staff is of the view that a licensee who wished to ship up to 37 grams of plutonium
previously would have done so in an NRC-certified Type B(U)F package, rather than splitting
the material up into a large number of shipments. The averted cost for this requirement,
therefore, arises from not having to perform a demonstration of 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 per 10 CFR 71.55 and 71.59. The NRC
estimates that a criticality safety assessment to support certification of this amount of material
would take an average of 40 hours, at an average cost of $200/hour. The NRC estimates that
the time needed to perform a typical criticality safety assessment review would take 43 hours,
on average, at an average cost of $131 per hour. The staff estimates that two certificates may
be revised to take advantage of the new general license requirements, over the next 10 years.
Table 27

Year

2022
2023
2024
2025
2026
2027
2028
2029
2030

Averted Licensee Cost to Obtain Approval for Shipment in Type BF Package

Description
Certificate holder averted
cost by adopting 10 CFR10
CFR 71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu

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$] a b
Undiscounted

7% NPV

3% NPV

0.18

$203

43

$1,602

$1,399

$1,510

0.18

$203

43

$1,602

$1,308

$1,466

0.18

$203

43

$1,602

$1,222

$1,424

0.18

$203

43

$1,602

$1,142

$1,382

0.18

$203

43

$1,602

$1,068

$1,342

0.18

$203

43

$1,602

$998

$1,303

0.18

$203

43

$1,602

$933

$1,265

0.18

$203

43

$1,602

$872

$1,228

0.18

$203

43

$1,602

$815

$1,192

42

Year

2031
2032

Description

No. of Certificate
Holders
Adopting 10
CFR 71.22 Limit

Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu
Certificate holder averted
cost by adopting 10 CFR
71.22 limit for Pu

Total
a
b

Certificate
Holder
Labor
Rate

No. of Hours
to Prepare
Criticality
Safety
Evaluation

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

0.18

$203

43

$1,602

$761

$1,158

0.18

$203

43

$1,602

$711

$1,124

2.00

$17,625

$11,229

$14,393

The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

Table 28

Averted NRC Cost to Review Application for Approval for Shipment in Type BF
Package

2022

NRC review criticality evaluation

No. of
Certificate
Holders
Adopting
71.22 Limit
0.18

2023

NRC review criticality evaluation

0.18

43

$131

$1,012

$826

$926

2024

NRC review criticality evaluation

0.18

43

$131

$1,012

$772

$899

2025

NRC review criticality evaluation

0.18

43

$131

$1,012

$722

$873

2026

NRC review criticality evaluation

0.18

43

$131

$1,012

$675

$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

Year

Description

No. of
Hours to
Review of
Criticality
Evaluation
43

NRC
Labor
Rate

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

$131

$1,012

$884

$954

Total Benefit (Cost)
$11,135
$7,094
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 between tables due to rounding.

$9,093

There may also be averted costs associated with this proposed change because licensees
would be able to ship a Type B package, as opposed to a Type BF. The NRC estimates that
there would be three affected shipments per year, on average, that would be made under this
revised provision. The staff estimates that the average averted cost per shipment of shipping in
a Type B versus a Type BF package would be $200.
Table 29
Year
2022
2023
2024
2025

Averted Licensee Cost to Make Shipment Using New Type B Package Limits

Description
Averted licensee cost to ship
under new Type B package limits
Averted licensee cost to ship
under new Type B package limits
Averted licensee cost to ship
under new Type B package limits
Averted licensee cost to ship
under new Type B package limits

No. of
Shipments

Incremental Cost
of Shipping a
Type B Versus a
Type BF Package

No. of
Licensees

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

3

$233

1

$700

$612

$660

3

$233

1

$700

$572

$641

3

$233

1

$700

$534

$622

3

$233

1

$700

$499

$604

43

Year

Description

No. of
Shipments

Incremental Cost
of Shipping a
Type B Versus a
Type BF Package

No. of
Licensees

Net Benefits (Cost) [2020$] a b
Undiscounted

Averted licensee cost to ship
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2027
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2028
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2029
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2030
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2031
3
$233
1
$700
under new Type B package limits
Averted licensee cost to ship
2032
3
$233
1
$700
under new Type B package limits
$7,704
Total
33
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 between tables due to rounding.
2026

7% NPV

3% NPV

$467

$587

$436

$569

$408

$553

$381

$537

$356

$521

$333

$506

$311

$491

$4,908

$6,292

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. Costs are higher in this case than in Issue 1, as these
packages require a fissile CSI label and associated accumulation restrictions.
Table 30

Year

2022
2023
2024
2025
2026
2027
2028
2029
2030

Licensee Averted Cost for Transporting Using General License in 10 CFR 71.22

Description
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22
Licensee averted shipment
costs shipping under 10
CFR 71.22

No. of
Shipments
of LowEnriched
235
U

Cost per
Shipment

11

11

11

No. of
Fissile
Material
Licensees

Net Benefits (Cost) [2020$] a b
Undiscounted

7% NPV

3% NPV

$1,850

$227,218

$198,461

$214,175

11

$1,850

$227,218

$185,478

$207,937

11

11

$1,850

$227,218

$173,343

$201,880

11

11

$1,850

$227,218

$162,003

$196,000

11

11

$1,850

$227,218

$151,405

$190,291

11

11

$1,850

$227,218

$141,500

$184,749

11

11

$1,850

$227,218

$132,243

$179,368

11

11

$1,850

$227,218

$123,592

$174,144

11

11

$1,850

$227,218

$115,506

$169,071

44

Year

Description

No. of
Fissile
Material
Licensees

No. of
Shipments
of LowEnriched
235
U

Net Benefits (Cost) [2020$] a b
Cost per
Shipment

Undiscounted

7% NPV

Licensee averted shipment
costs shipping under 10
11
11
$1,850
$227,218
$107,950
CFR 71.22
Licensee averted shipment
2032
costs shipping under 10
11
11
$1,850
$227,218
$100,887
CFR 71.22
$2,499,397
$1,592,368
Total)
121
121
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 between tables due to rounding.
2031

3% NPV
$164,147
$159,366
$2,041,128

4.2.15 Other Recommended Changes to 10 CFR Part 71
4.2.15.1

Issue 15.1. Deletion of Duplicative Reporting Requirements

Since the NRC is proposing to delete duplicative requirements, reporting instances in which
licensees perform a shipment that is not in accordance with the regulations would still be
reportable under 10 CFR 71.95(b) and there would 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

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

There is no cost impact expected from revising the values in Table A-1 and A-2 in Appendix A to
10 CFR Part 71. Revising the items in the tables would align the information with the values in
the DOT regulations and would be consistent with SSR-6, 2018 Edition. Since the values for A1
and A2 are either remaining the same or increasing, and currently there are no packages
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 proposing to revise 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 § 71.21, § 71.22 or § 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 from Agreement State licensees
pursuant to 10 CFR 71.95(a) over the next 11-year period. The NRC expects that Agreement
States that incorporate these changes will get approximately two reports per Agreement State

45

per year pursuant to 10 CFR 71.95(b) reporting of instances in which the CoC was not followed
during shipment. The NRC estimates that licensees submitting these reports will take
approximately 3 hours to complete the report and submit it to an Agreement State. The NRC
estimates on the amount of time to review the report ranges from a low of 1 hour, for reading
and digesting the content of the report, to a high of 5 hours to review the report and write a
report summarizing the licensees report, with an average of approximately 3 hours. 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 31
Year

2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032

a
b

Agreement States Costs to Review Reports

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$] a b
Undiscounted

7% NPV

Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($20,646)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($19,295)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($18,033)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($16,853)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($15,751)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($14,720)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($13,757)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($12,857)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($12,016)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($11,230)
reports
Agreement State cost to
review 10 CFR 71.95
(39)
2
3
$101
($23,637)
($10,495)
reports
22
($260,012) ($165,654)
Total
The results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
There may be differences between tables due to rounding.

4.2.15.5

3% NPV
($22,281)
($21,632)
($21,002)
($20,390)
($19,796)
($19,219)
($18,660)
($18,116)
($17,589)
($17,076)
($16,579)
($212,339)

Deletion of Redundant Advance Notification Requirements for Shipment of Spent
Fuel

Revising 10 CFR 71.97 to remove the requirement for advance notification of shipment of
irradiated reactor fuel would not change the requirements for advance notification of nuclear
waste. Since reporting would still be required by either 10 CFR 73.35 or 10 CFR 73.37 there
would not be an increase or decrease in licensee costs for this rule clarification.

46

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 @Risk®
software 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
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 staff’s 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.

1

Information about this software is available at http://www.palisade.com.

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.

47

The results of the uncertainty analysis are provided graphically in Figures A-1 through A-12
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 estimates for several issues were not included in the uncertainty analysis for the following
reasons. Issue 2 has no graph because there are no incremental costs or benefits. 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-13, shown on page A-8, is reproduced here and shows a tornado diagram that
identifies the key variables whose uncertainty drives the largest impact on the net benefits for
the combined recommended alternative—that is, the recommended alternative for each issue
taken together and calculated as an aggregate. Figure A-13 ranks the variables based on their
contribution to cost uncertainty.
The proposed approach to addressing Issues 1, 14, and 4 drives the most uncertainty in the
expected benefits.

Figure A-13 Tornado Diagram of Rulemaking–7-Percent NPV
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 would
result in a change to the mean of $4.20 million, the difference in averted costs that ranges
between $0.91 million to $5.11 million with a 90-percent confidence level. The uncertainty in
material shipment cost ranges could result in a change in Issue 1 that would result in a change
to the mean of $2.86 million (the difference in averted costs that ranges between $1.53 million
to $4.39 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 is $712,000.

48