Regulatory Analysis for Part 71 Revisions to Transportation Safety Requirements Proposed Rule

Regulatory Analysis for Proposed Rulemaking Compatibility with IAEA Transportation Standards
(10 CFR Part 71)

U.S. Nuclear Regulatory Commission
November 2012

Table of Contents
EXECUTIVE SUMMARY

ii

ABBREVIATIONS

iii

1.

INTRODUCTION

1

1.1

Statement of the Problem and Objective of the Rulemaking

1

1.2

Background

2

2.

IDENTIFICATION OF ALTERNATIVE APPROACHES

3

2.1

Alternative 1: The No-Action Alternative

3

2.2

Alternative 2: IAEA-DOT Compatibility

3

2.3

Alternative 3: IAEA-DOT Compatibility and NRC Initiated Changes

4

3. ESTIMATION AND EVALUATION OF VALUES AND IMPACTS

5

3.1

Identification of Affected Attributes

6

3.2

Analytical Methodology

8

3.2.1

General Assumptions

9

3.2.2

Specific Assumptions for Alternative 2

10

3.2.3

Specific Assumptions for Alternative 3

13

3.2.4

Data on Affected Entities

14

4. PRESENTATION OF RESULTS

14

4.1

Summary of Results

15

5. DECISION RATIONALE

22

6. IMPLEMENTATION

22

7. REFERENCES

23

Appendix 1: Input Assumptions and Line Item Results relating to Alt 2

25

Appendix 2: Detailed Quantitative Results relating to Licensee and NRC Costs/Savings for Alt 3

27

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EXECUTIVE SUMMARY
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. These amendments would 1) conform the NRC
regulations to the 2009 edition of the International Atomic Energy Agency’s (IAEA) international
transportation standards, 2) maintain consistency with changes in the DOT regulations, and
3) make other changes to the requirements for the packaging and transportation of radioactive
material. These changes are necessary to maintain a consistent regulatory framework for the
transportation and packaging of radioactive material. In addition, these changes would make
the regulation of Quality Assurance (QA) programs more efficient by removing the requirement
for prior approval of QA programs for users of packages, allowing changes that do not change
commitments to be made without prior NRC approval, and removing the requirement to renew a
QA program.
This Regulatory Analysis (RA) provides an evaluation of three alternatives. The preferred
alternative is Alternative 3 (see section 2.3 of this document) which would change regulations as
specified in the proposed rule.
The RA makes the following key findings:
Total cost to Industry: The proposed rule would result in a one-time cost to the industry of
approximately $95,000 and would have a total annual savings of about $112,000.
Total cost to the NRC: The rule would result in a one-time cost to the NRC of approximately
$367,000, followed by annual cost savings of approximately $22,000.
Total cost to Agreement States: Agreement States would be required to review proposed rule
language and to amend its regulations consistent with the final rule. The rule would result in a
one-time cost to Agreement States of approximately $1.8 million.
Decision Rationale: Based on the analysis described below, the NRC concludes that the
proposed rule, if implemented, would provide compatibility with IAEA and DOT regulations and
would make certain NRC-initiated regulatory changes to improve regulatory efficiency and to
provide benefits to licensees and to the NRC and Agreement States with a small change to
measures of impacts to public health and safety.
The proposed rule is planned for publication in the Federal Register in October 2012. Following
a public comment period and several months to review the public comments, the NRC will
revise the proposed rule and publish a final rule, as appropriate.

ii

ABBREVIATIONS
ADAMS
AS
CFR
CRCPD
CoC
CSI
DOE
DOT
IAEA
ISO
LSA
NRC
NPV
NUREG
OMB
QA
RA
SSR-6
TS-R-1

Agencywide Documents Access and Management System
Agreement States
Code of Federal Regulations
Conference of Radiation Control Program Directors
Certificate of Compliance
Criticality Safety Index
U.S. Department of Energy
U.S. Department of Transportation
International Atomic Energy Agency
International Organization for Standardization
Low Specific Activity
U.S. Nuclear Regulatory Commission
Net Present Value
Nuclear Regulatory Publication
Office of Management and Budget
Quality Assurance
Regulatory Analysis
IAEA Specific Safety Requirements Number SSR-6, “Regulations for the
Safe Transport of Radioactive Material”
IAEA Safety Requirements Number TS-R-1: “Regulations for the Safe
Transport of Radioactive Material”

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1.

INTRODUCTION

The U.S Nuclear Regulatory Commission (NRC) is planning to publish a proposed rule
amending its regulations for packaging and transportation of radioactive material. These
amendments would make NRC regulations consistent with 2009 revisions to the International
Atomic Energy Agency’s (IAEA’s) transportation standards, “Regulations for the Safe Transport
of Radioactive Material,” (TS-R-1). The NRC co-regulates domestic transportation of
radioactive material with the U.S. Department of Transportation (DOT). DOT regulations
regarding transportation of radioactive materials are in Title 49 of the Code of Federal
Regulations (49 CFR) Parts 107, 171-180, and 390-397. The NRC and the DOT are publishing
proposed rules with the dual purpose to achieve compatibility with IAEA’s transportation
standards and to improve regulatory efficiency by maintaining a consistent regulatory
framework. The NRC is also proposing to make other changes which do not affect compatibility
with the IAEA TS-R-1 or the DOT hazardous material regulations as discussed in more detail
below.
This Regulatory Analysis (RA) presents background material, rulemaking objectives,
alternatives, and input assumptions, and describes the consequences of the rule language and
alternative approaches necessary to accomplish the regulatory objectives.
1.1

Statement of the Problem and Objective of the Rulemaking

The proposed amendments would revise NRC regulations for the packaging and transportation
of radioactive material to: 1) make the NRC regulations compatible with the 2009 edition of the
IAEA TS-R-1; 2) maintain consistency with changes in the DOT regulations; and 3) make other
changes to the requirements for the packaging and transportation of radioactive material, which
do not affect compatibility with the IAEA’s TS-R-1 or the DOT’s hazardous material regulations.
The IAEA revises its transportation standards periodically to reflect acquired knowledge and
experience. The NRC periodically updates its transportation regulations at 10 CFR Part 71 to
reflect the changes in the IAEA’s transportation standards.
One objective of the proposed rule would be to achieve compatibility with the IAEA’s
transportation standards. DOT is proposing the same amendments in its proposed rule to
achieve compatibility with TS-R-1. Amendments to achieve compatibility are referred to in this
document as the “IAEA-DOT compatibility” alternative. The amendment would allow a licensee
who transports special form radioactive material, and who is using a specimen to simulate
radioactive material contained in a sealed capsule, to use an alternative impact test currently
allowed by the IAEA in TS-R-1 as one of the acceptable impact tests cited in the regulations.
The amendments in the “IAEA-DOT compatibility” alternative are expected to have little impact
on the public and on licensees, and will have only a minor impact on the NRC due to the onetime implementation cost to prepare the final rule, and amend regulations. In November 2012,
the IAEA issued new standards for the safe transport of radioactive material and designated
them as “Specific Safety Requirements Number SSR-6” (SSR-6). This rulemaking does not
incorporate the 2012 IAEA changes, which will undergo a comprehensive review by the NRC
staff to determine if additional changes to 10 CFR Part 71 are warranted.
Another objective of the proposed rule is be to increase the efficiency of the oversight of Quality
Assurance (QA) program. The NRC requires licensees to comply with their own NRC approved
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QA programs. The NRC is proposing changes that would 1) establish a mechanism to allow
some changes to be made in an approved QA program without obtaining prior NRC approval
and 2) remove the requirements for renewal of QA program approvals. These changes would
increase the efficiency of the NRC oversight of quality assurance by removing the need for
holders of the QA program approval to obtain prior NRC approval of amendments to QA
program descriptions that do not reduce the commitments in an approved QA program. This
would allow holders of QA program approvals to implement changes more quickly.
The proposed amendments to 10 CFR Part 71 that would permit holders of the QA program
approval to make changes to their QA program without NRC approval are modeled after those
in 10 CFR Part 50. Holders of a QA program approval would only need to submit to the NRC
for prior approval those changes to their QA program that would reduce commitments made to
the NRC. Under the proposed rule, holders of a QA program approval would be required to
report to the NRC at least every 24 months any changes they have made to their approved QA
program.
1.2

Background

Hazardous materials, including radioactive material, are transported regularly as part of
international commerce. Shipping companies that are active in the international transport of
radioactive material must comply with international legal instruments that are often based on
standards published by the IAEA and adopted by IAEA Member States. The U.S. adopts many
of the IAEA international transportation regulations into its domestic transport regulations, with
regulatory changes implemented through the rulemaking process. The NRC and the DOT strive
to maintain consistency or compatibility between the domestic transport regulations and the
IAEA’s transportation standards. The effort to maintain consistency or compatibility between
national regulations and internationally-accepted requirements is known as "harmonization."
There is a need for the NRC and the DOT to harmonize1 domestic transport regulations with
changes made to the IAEA’s TS-R-1 over the past several years. These changes can be
implemented with slight cost to the public and domestic regulatory authorities responsible for
implementing the proposed changes.
A second set of changes is being proposed to eliminate unnecessary administrative
requirements that require licensees to submit documents to the NRC for approval. The current
regulations require holders of a QA program approval to obtain prior NRC approval of every
change to their QA program, of which some are administrative, such as the transfer of functional
responsibility within organizations and generic organizational position titles. The proposed rule
would amend this by making the 10 CFR Part 71 transportation QA requirements similar to the
requirements for making changes to a QA program that apply to 10 CFR Part 50 licensees. The
amended transportation requirements would require QA program changes to be submitted to
1

The regulations in the IAEA’s TS-R-1 represent an accepted set of requirements that are considered to
provide a high-level of safety in the packaging and transportation of radioactive materials and provide a
basis and framework that facilitates the development of internationally-consistent regulations.
Internationally-consistent regulations for the transportation and packaging of radioactive material reduce
impediments to trade, facilitate international cooperation, and, when the regulations provide a high-level
of safety, can reduce risks associated with the import and export of radioactive material. Harmonization
represents the effort to increase the consistency or compatibility between national regulations and the
internationally-accepted requirements, within the constraints of an existing national legal and regulatory
framework.

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the NRC only if the change results in a reduction in the commitments made to the NRC
compared to the currently approved QA program. This change is being made to promote
savings on the part of industry and regulators. The proposed amendments would require
holders of the QA program approval to report to the NRC at least every 24 months any changes
they have made to their approved QA program.
2. IDENTIFICATION OF ALTERNATIVE APPROACHES
The following sections describe the regulatory options that the NRC is considering in order to
meet the rulemaking objectives identified in the previous section. Section 3 presents a detailed
analysis. The NRC considered three alternatives for the proposed rule, described in the
following three sections. The full list of changes which indicate their relationship to the
alternatives are provided in Table 4-3 which summarizes the costs by entity, over a 10-year
analysis period.
2.1

Alternative 1: The No-Action Alternative

The No-Action alternative would maintain the status quo. Under the No-Action Alternative, the
NRC would make no changes to the current regulations in 10 CFR Part 71 and there would be
no costs or benefits. Alternative 1 would avoid costs that the proposed rule would impose;
however, it would allow greater divergence between the international standards and the
domestic regulations. Radioactive material is imported and exported. Consistency between
domestic and international transportation regulations facilitates international commerce.
Differences in domestic and international regulations can make it more complicated and
expensive to import or export radioactive material and inhibit trade. There would be no changes
made that would enhance the current level of protection for public health and safety. Also, there
would be no changes made to improve regulatory efficiency and the resulting benefits to certain
segments of the transport industry. This is the baseline of the RA.
2.2

Alternative 2: IAEA-DOT Compatibility

This alternative would amend the NRC regulations to increase consistency and compatibility
with the 2009 edition of the IAEA’s TS-R-1 and with changes proposed by the DOT.
•

Section 71.4, Definitions. The definition of contamination would be added. The
definitions for “Criticality Safety Index (CSI),” “Low Specific Activity (LSA) material,”
“special form radioactive material,” and “uranium ─ natural, depleted, enriched” would be
revised.

•

Section 71.14, Exemption for low-level material. Paragraph (a) would be changed to
revise the exemption to include natural material and ore that has been processed to
qualify for the exemption. Paragraph (a)(3) would be added to provide an exemption for
non-radioactive solid objects which have radioactive substances present on their
surfaces, provided that the quantity of radioactive substances is below that which is used
to define contamination.

•

Paragraph 71.75(d), Qualification of special form radioactive material. This change
would update the International Orgnization for Standardization (ISO) Class 4 impact test
and ISO Class 6 temperature test to those prescribed in ISO 2919:1999(E), “Radiation
3

protection — Sealed radioactive sources — General requirements and classification,”
and would allow the ISO Class 5 impact tests prescribed in ISO 2919:1999(E) to be
used if the specimen weighs less than 500 grams.
•

Appendix A., Table A-1, A1 and A2 Values for Radionuclides. The table would be revised
by adding an entry for krypton-79 (Kr-79); revising entries for californium-252,
iridium-192, krypton-81, and molybdenum-99; and revising footnotes to be consistent
with the IAEA’s TS-R-1.

•

Appendix A, Table A-2, Exempt Material Activity Concentrations and Exempt
Consignment Activity Limits for Radionuclides. The table would be revised by adding an
entry for Kr-79, revising the entry (values) for tellurium-121m (Te-121m), and revising
footnote b.

2.3

Alternative 3: IAEA-DOT Compatibility and NRC Initiated Changes

This alternative includes 1) all of the proposed changes comprising Alternative 2, which would
amend the NRC regulations to increase consistency and compatibility with the 2009 edition of
the IAEA’s TS-R-1 safety standards, and maintain consistency with changes proposed by the
DOT; and 2) implement NRC-initiated changes.
The changes listed below are consistent with Alternative 3 to Compatibility with IAEA
Transportation Standards in 10 CFR Part 71.
•

Section 71.15, Exemption from classification as fissile material. The exemption in
paragraph (d) that applies to uranium enriched in uranium-235 to a maximum of 1
percent by weight, and with total plutonium and uranium-233 content of up to 1 percent
of the mass of uranium-235, provided that the mass of any beryllium, graphite, and
hydrogenous material enriched in deuterium constitutes less than 5 percent of the
uranium mass, (hereafter referred to as uranium enriched to a maximum of 1 percent)
would be revised to require the material to be distributed homogeneously and not form a
lattice arrangement.

•

Section 71.38, Renewal of a certificate of compliance. This section would be retitled and
revised to remove references to renewals of QA program approvals, which would no
longer be necessary.

•

Section 71.85, Preliminary determinations. This section would be revised to replace
“licensee” with “certificate holder” in paragraphs (a), (b), and (c); and paragraph (d)
would be added to require that licensees ascertain that the preliminary determinations
made by the certificate holder (paragraphs (a) – (c)) have been made.

•

Section 71.106, Changes to quality assurance program. This section would be added to
revise the process for holders of a QA program approval to make changes to an
approved QA program and would require periodic reporting of those changes that do not
require prior NRC approval.

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Section 71.135, Quality assurance records. This section would be revised to include
changes made to an approved quality assurance program as a quality assurance record.

The NRC has estimated the benefits and costs of these alternatives. The costs and benefits are
evaluated and described in Sections 3 and 4 of this RA. The rationale for the NRC decision to
pursue Alternative 3 is discussed in Section 5.
3. ESTIMATION AND EVALUATION OF VALUES AND IMPACTS
This section examines the values (benefits) and impacts (costs) expected to result from the
proposed changes to 10 CFR Part 71. The benefits and costs are analyzed for Alternatives 2
and 3, and are set forth by the societal attributes that are considered important for the
evaluation of the proposed amendments.
Throughout this RA, various labor rates are used. These labor rates are used consistently for
all of the issues. The bases for the labor rates are described below. Labor rates for licensees ─
including holders of a Certificate of Compliance (CoC) or a QA program approval and applicants
─ and Agreement States were obtained from National Wage Data databases available on the
Bureau of Labor Statistics Web site (www.bls.gov). Depending on the industry and the
occupation (e.g., manufacturing, health and safety, etc.), an appropriate mean hourly labor rate
was determined. The hourly cost was determined by multiplying the hourly labor rate by 1.5 to
account for benefits (insurance premiums, pension, and legally required benefits). Nationwide
mean hourly labor rates are used, because exact hourly rates are difficult to obtain and may not
be sufficiently recent. For licensee labor rates, $73.20/hour ($48.80/hour X 1.5) is used, which
is from the Bureau of Labor Statistics Employer Costs for Employee Compensation data set,
“Nuclear Engineers.” For all Agreement State labor rates, $60.80/hour ($40.53/hour X 1.5) is
used, which is from the Bureau of Labor Statistics Employer Costs for Employee Compensation
data set, “Lawyers.”
The NRC labor rates are determined per the calculation methodology in Abstract 5.2, “NRC
Labor Rates,” of NUREG/CR-4627, Rev.1, Generic Cost Estimates, Abstracts from Generic
Studies for Use in Preparing Regulatory Impact Analyses.” Currently, the hourly labor rate for
the NRC is $119.
The estimation of costs for rulemaking is based on professional NRC staff full-time equivalent
(FTE). Based on actual data from the NRC time and labor system, the number of hours in
1 year that directly relate to implementation of assigned duties is 1,451; this excludes hours on
such things as leave, training, and completing administrative tasks. Therefore, an NRC
professional staff FTE hourly rate is based on 1,451 hours per year.
The estimated costs for the Agreement States to amend and implement changes to their
regulations are based on the number of productive hours in one year, as described in the Office
of Management and Budget (OMB) Circular A-76, "Performance of Commercial Activities”,
which is 1,776. The actual number of productive hours per year is likely to vary from state to
state and no specific data are available. Costs for the Agreement States are calculated using
the 1,776 productive hours per year from OMB Circular A-76 per FTE.

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3.1

Identification of Affected Attributes

This section lists the significant attributes for this proposed rulemaking and describes the
expected changes in the context of these attributes. The benefits and costs for each attribute
are quantified using the methodology described in Section 3.2. Those attributes that are not
expected to be affected by the proposed amendments are listed at the end of the Section 3.1.
NUREG/BR-0184, “Regulatory Analysis Technical Evaluation Handbook,” identifies a set of
attributes to be evaluated. All of the attributes listed in NUREG/BR-0184 are addressed below.
No additional attributes that would inform the evaluation of values and impacts for this proposed
rulemaking were identified.
•

Industry Operation: The NRC is proposing to make changes that would make the
regulation of QA programs more efficient. The NRC is proposing to issue QA program
approvals that would not expire, removing the need for the approval to be renewed, and
would revise the current QA program approvals so that they would not expire. The NRC is
also proposing to allow those changes that do not reduce the commitments in an approved
QA program to be made without prior NRC approval. Additional material might qualify for
the exemption of low-level radioactive material, which would facilitate the transportation of
these materials and reduce shipping costs. In aggregate, industry operations are
anticipated to be improved, resulting in savings.

•

Industry Implementation: If the proposed action is adopted/promulgated the licensee will
need to purchase a copy of the ISO standards as well as maintain awareness of changes to
the relevant transportation regulations. Each licensee will need to read the new regulations
and determine actions necessary. Changes to 10 CFR 71.75(d), which would incorporate
by reference the alternate Class 4 impact test and Class 6 temperature test and allow the
Class 5 impact tests to be used if the specimen weighs less than 500 grams, will require the
licensee to incur a one-time cost for the purchase of equipment.

•

NRC Implementation: Under the proposed action, the NRC would publish the draft rule for
public comment. The NRC plans to consider any public comments received, develop a final
rule and amend guidance to be consistent with the new requirements. With the publication
of the final rule, the NRC would re-issue QA program approvals with no expiration date. The
NRC would also review and evaluate State regulations developed by the Conference of
Radiation Control Program Directors (CRCPD) and will review amendments to Agreement
State regulations for compatibility. Under Alternative 2 and Alternative 3, the NRC would
need to update guidance.

•

Other Governments: Agreement States would incur costs associated with efforts to amend
their regulations and guidance, which may also include costs associated with the CRCPD
development of Suggested State Regulations for Control of Radiation. Agreement State
governments will incur one-time costs to amend regulations to implement Alternative 2 or
Alternative 3, and annual savings due to improved regulatory efficiency from Alternative 3.
The U.S. Department of Energy (DOE) certifies their own packages and may use them for
the transportation of Class 7 (radioactive) material when evaluated, approved and certified
using standards equivalent to those specified in 10 CFR Part 71. The DOT also requires
that for Class 7 material shipped by the DOE, that the packages be marked and prepared
6

for shipment in a manner equivalent to that required of NRC licensees. Consequently, the
DOE would need to comply with proposed amendments to the fissile material exemption.
The NRC and the DOT adopted a memorandum of understanding (44 FR 38690; July 2,
1979) to delineate their respective roles in the regulation of the transportation of radioactive
material. The NRC, in consultation with the DOT, develops safety standards for the design
and performance of packages for fissile materials and for quantities of other radioactive
materials, other than LSA materials, exceeding Type A limits. The areas where the NRC
develops safety standards include: criticality control and quality assurance of packaging
design, fabrication, testing, maintenance, and use.
•

Regulatory Efficiency: The proposed amendments include changes to harmonize 10 CFR
Part 71 with the international standards and to maintain consistency with the DOT
regulations. This will help to achieve and maintain regulatory efficiency. The proposed rule
will incorporate by reference consensus standards used for the qualification of special form
material, which also contributes to regulatory efficiency. Changes to the general license
provisions would provide additional clarity as to the responsibilities of the general licensee,
which will improve compliance and regulatory oversight. Changes to the requirements for
making preliminary determinations would make the requirements more consistent with
current practice and improve compliance. In Appendix A, improving the row headings in
Table A-3 for clarity, and correcting and adding equations for calculating values for mixtures
of radionuclides will also contribute to improved regulatory efficiency by making it easier for
licensees to comply.
The proposed rulemaking would modify the process for making changes to QA programs,
which will increase efficiency for holders of a QA program approval and the NRC oversight
of QA programs. Holders of a QA program approval would not need to apply to renew their
approval and the NRC would not have to review future renewals of QA program approvals.
With the publication of a final rule, the NRC would re-issue QA program approvals with no
expiration date.

•

Environmental Considerations: The proposed rulemaking would involve changes that
could have environmental impacts. The proposed amendments would expand the low-level
material exemption for natural material and ores containing naturally occurring radionuclides
to allow material that has been processed to qualify for the exemption. These changes
would increase the number of shipments of low specific activity radioactive material that
would be exempt from the NRC and the DOT transport regulations (i.e., would not be
shipped as hazardous material). The Environmental Assessment (Agencywide Document
Access and Management System (ADAMS) Accession No. ML12187A109) discusses the
environmental considerations in greater detail. After evaluating the potential impacts, the
NRC determined that there would be no significant impact to the public from the proposed
amendments.

•

NRC Operations. Holders of a QA program approval would not need to apply to renew
their approval and the NRC would not have to review future renewals of QA program
approvals. With the publication of a final rule, the NRC would re-issue QA program
approvals with no expiration date. The NRC would need to review the biennial reports of
changes to QA programs that do not reduce commitments to the NRC. The proposed action
would result in a small annual savings to the NRC in the oversight of QA programs.
7

The following attributes are not expected to be affected:
Public Health (Accident)
Public Health (Routine)
Antitrust Considerations
Improvements in Knowledge

Offsite Property
Onsite Property
General Public

Occupational Health (Accident)
Occupational Health (Routine)
Safeguards and Security

Section 4 presents the results, in constant 2012 dollars. The results are shown for the one-time
costs (or benefits) and the annual operating expense (or savings) to implement Alternatives 2
and 3. The total benefits and costs over the 10-year analysis period are estimated using
7 percent and 3 percent real discount rates.
The estimated total cost for Alternative 3 is approximately $1.1 million and $1.3 million,
discounted at 3 percent and 7 percent, respectively for the preferred approach. The 3 percent
discounted value is less than the 7 percent discount value because of the large amount of
annual cost savings to the industry and the NRC.
3.2

Analytical Methodology

This section describes the methodology used to analyze the values and impacts associated with
the proposed rule. The values (benefits) consist of any desirable changes in the affected
attributes. The impacts (costs) consist of any undesirable changes in the affected attributes. To
the extent practical, quantitative information (e.g., costs and savings) and qualitative information
on attributes affected by the proposed rule have been obtained from NRC staff.
As described in Section 3.1, the attributes expected to be affected include the following:
•
•
•
•
•
•
•

Industry Operation
Industry Implementation
NRC Implementation
NRC Operation
Other Governments
Regulatory Efficiency
Environmental Considerations

In accordance with guidance from the Office of Management and Budget (OMB) and
NUREG/BR-0058, Rev. 4, this RA presents the results of the analysis using both 3-percent and
7-percent real discount rates. The real discounted rates or present-worth calculation simply
determines how much society would need to invest today to ensure that the designated dollar
amount is available in a given year in the future. By using present-worth, costs and benefits,
regardless of when averted in time, are valued equally. Based on OMB guidance (OMB Circular
No. A-4, September, 17, 2003), present-worth calculations are presented using both 3 percent
and 7 percent real discount rates. The 3 percent rate approximates the real rate of return on
long-term government debt which serves as a proxy for the real rate of return on savings. This
rate is appropriate when the primary effect of the regulation is on private consumption.
Alternatively, the 7 percent rate approximates the marginal pretax real rate of return on an
average investment in the private sector, and is the appropriate discount rate whenever the
main effect of a regulation is to displace or alter the use of capital in the private sector. The
8

NRC seeks public comments on the accuracy of these RA assumptions and on the validity of
the proposed rule’s value and impact estimation methods. The NRC has specifically requested
comments from the public on this assumption in the RA.
The RA includes assumptions and estimates. The NRC staff relied on referenced sources for
the assumptions and estimates when these were available. In some cases, the NRC was not
aware of any input data and in these cases the NRC staff made an estimate based on best
professional judgment. These are noted as “staff judgment” in the descriptions of the input data.
The NRC seeks public comments on the accuracy of the assumptions and estimates used in
this RA, and on the validity of the method to estimate values and impacts of the proposed rule.
3.2.1

General Assumptions

Costs are expressed in 2012 dollars and are modeled either on an annual recurring cost basis
or on a one-time implementation basis. The RA calculates costs over a 10-year analysis period,
with the annual costs in each year beyond 2012 discounted back at a 7-percent and 3-percent
discount rate, in accordance with NUREG/BR-0058, Rev. 4.
The [NRC staff’s] general input assumptions for the analysis are discussed below.
•

The NRC labor rates are determined using the methodology in Abstract 5.2, “NRC Labor
Rates,” of NUREG/CR-4627, Rev. 1. This methodology considers only variable costs
that are directly related to the implementation, operation, and maintenance of the
proposed amendments. Currently, the NRC hourly labor rate is $119.

•

The NRC staff determined Licensee labor rates using National Wage Data available on
the Bureau of Labor Statistics Web site (www.bls.gov). Depending on the industry and
the occupation (e.g., manufacturing, health and safety, etc.), an appropriate mean hourly
labor rate is selected. Because exact hourly rates would be difficult to obtain and may
not be sufficiently recent, nationwide mean hourly rates are used. For all licensee labor
rates, $73.20/hour is used, which is from Bureau of Labor Statistics Employer Costs for
Employee Compensation data set, “Nuclear Engineers.”

•

The NRC staff determined Agreement State labor rates using National Wage Data
available on the Bureau of Labor Statistics Web site (www.bls.gov). Because exact
hourly rates would be difficult to obtain and may not be sufficiently recent, nationwide
mean hourly rates are used. For all Agreement State labor rates, $60.80/hour is used,
which is from Bureau of Labor Statistics Employer Costs for Employee Compensation
data set, “Lawyers”.

•

The DOE hourly labor rates will match the NRC rate, i.e., $119/hour.

•

The NRC staff estimates there are 290 entities ─ 210 general licensees or users of
packages, 40 certificate holders/applicants for certificate holders, 37 Agreement States,
DOE, DOT, and CRCPD ─ would be directly impacted by the proposed amendments.
The CRCPD impacts ─ development of Suggested State Regulations for Control of
Radiation ─ would be a subset of, and considered as part of, the Agreement State
impacts, because it would be Agreement State staff working to develop the Suggested
State Regulations for Control of Radiation.
9

•

The time period for the analysis is 10 years. Renewals of QA program approvals are
required every 10 years. The 10-year period for the analysis was selected to cover one
complete QA program approval renewal period.

•

Estimates were made for one-time implementation costs. It is assumed that the costs
will be incurred in the first year of the analysis. This will provide a conservative estimate
of the one-time implementation costs, because one-time costs that may occur later (e.g.,
rulemaking conducted by the Agreement States would not be discounted).

•

3.2.2

•

There are one-time implementation costs assumed for the NRC and the
Agreement States.

•

One time implementation costs for the transportation industry may be incurred in
response to amendments to 10 CFR Part 71. The area’s most likely to contribute
to one-time implementation costs include: 1) exemption of low-level materials,
2) preliminary determinations, 3) qualification of special form material; and 4)
quality assurance.

Estimates were made for recurring annual operating expenses to support
implementation of the rule. The values for annual operating expenses are assumed to
be identical for each of the 10 years in the analysis. The annuity formula used to
discount the annual expense values is on page B.3 of NUREG/BR-0184.
Specific Assumptions for Alternative 2

Under Alternative 2, the NRC would amend two sets of domestic transport regulations to
maintain compatibility with the IAEA’s TS-R-1 transportation standards revised in 2009. These
changes will impact licensee shipping costs as well as rulemaking costs for the NRC and the
Agreement States. The specific [NRC staff] assumptions for Alternative 2 are:
•

•

There are one-time costs that may be incurred in response to changes to 10 CFR
Part 71.
o

It is assumed that licensees and certificate holders maintain awareness of
changes to the relevant transportation regulations, but would incur costs
associated with this effort. It is estimated that 50 percent of licensees would
obtain materials relating to training on the current requirements, with commercial
references estimated to cost $60 and a total cost of $7,500.

o

It is assumed that some effort would be made to review the changes in the
regulations. The proposed rulemaking includes 24 proposed amendments. It is
estimated that an average of 2 hour per licensee or certificate holder would be
spent reviewing the changes, for a total of approximately $35,000.

The changes to 71.14(a) would allow some additional material and objects to be shipped
under the exemption. Natural material and ore containing naturally occurring
radionuclides that has been processed could be shipped without being classified as
hazardous material if it meets the expanded exemption. The material would not be
10

shipped for the use of its radionuclides. Licensees would need to ensure correct
labeling and placarding for their shipments. This would require them to determine
whether material can be shipped under the exemption if it is to be treated as radioactive
material.
o

Because the material is not being shipped for use of its radionuclides, it is
assumed that most licensees would be unaffected by this change. It is assumed
that about 2 percent of licensees (five licensees) would be affected by this
change.

o

The number of DOE shipments affected is estimated to be 0.5 percent of the
low-level wastes and “other” radioactive material shipments in 2004. This
corresponds to approximately 6 rail shipments and 74 truck shipments.

o

The quantity of material shipped by industry is based on the average
consumption for the following: tantalite ore, niobium ore, and rare earth
concentrates for the years (2006 – 2010) where consumption amounts are
available in the U.S. Geological Survey Mineral Commodity Summaries after
being adjusted to better approximate the amount of material affected by the
proposed change. It is also assumed that the tantalite slag and niobium slag are
transported in the same quantities as tantalite ore and niobium ore, respectively.

o

The fraction of tantalite ore and tantalite slag affected by the proposed change is
estimated using information from the Tantalum-Niobium International Study
Center that was included in the IAEA Coordinated Research Program and the
activity levels listed in “The Trade in Radioactive Materials ─ Potential Problems
and Possible Solutions” by Nick Tsurikov (2008) and “Regulation of Natural
Radioactivity in International Transport and Trade” by N. Tsurikov, et. al. (2006).
The estimates for niobium and niobium slag assume the fraction of material less
than 10 Bq/g of uranium-238 and thorium-232 are the same as that estimated by
the Tantalum-Niobium International Study Center for tantalite ore and tantalite
slag.

o

It is assumed that the material is processed, but not for its radionuclides.
Because assuming that the material, with the exception of the slag, has been
processed is likely to overestimate the quantity of material evaluated that would
qualify for the exemption, the volume of material and the number of shipments
would include the shipment of some material not specifically evaluated.

o

It is estimated that approximately 12,000 metric tons of material is shipped by rail
in approximately 125 railroad cars (or shipments).

o

It is assumed that annual fees and permits would not be affected by this change,
because some material would still be shipped as class 7 (radioactive) hazardous
material.

o

It is estimated that approximately $500 per shipment would be saved, because
the material would not be shipped as radioactive material.
11

•

The NRC is proposing to incorporate by reference ISO 9978:1992(E), “Radiation
protection ─ Sealed radioactive sources ─ Leakage test methods” and ISO 2919:1999(E),
“Radiation protection ─ Sealed radioactive sources ─ General requirements and
classification.” The NRC is allowing the use of certain ISO tests as an alternative to the
tests prescribed by 10 CFR Part 71. The NRC is allowing the use of the Class 4 and
Class 5 impact tests and the Class 6 temperature test. The ISO Class 5 impact test can
be used for a specimen weighing less than 500 grams. The ISO tests are more rigorous
than the tests prescribed in 10 CFR Part 71, so they are not the most common tests used
to qualify special form material.
o

It is assumed that each licensee would obtain a copy of the ISO standards. It is
also assumed that they would acquire the standards at the non-member rate.
These estimates would be conservative in estimating the costs. Purchasing the
two standards from the distributor in the U.S. would cost each licensee $200.

o

The NRC staff estimates there are 60 Class 4 and Class 6 tests performed each
per year. Although the ISO standard that includes these tests has been updated,
it is assumed that no new equipment is needed to perform these tests.

o

The Class 5 impact tests allow a smaller hammer to be used for smaller
specimens. It is assumed that acquiring the testing equipment would cost $500
for each licensee who acquires the equipment. It is assumed that about 5
percent of the licensees (rounded up to 5 licensees) would purchase the
equipment, for a total cost of $2,500.

o

It is estimated that licensees would perform 50 Class 5 impact tests each year
instead of the Class 4 impact at an equivalent savings of the costs for one labor
hour per test, for a total savings of $3,660.

Other changes would amend certain values in 10 CFR Part 71, Tables A-1, A-2, and A-3,
Appendix A. See chart in Appendix 1 for a summary of the proposed changes and estimates for
the effect of each change. These changes would result in an estimated net savings of $20,000
annually for the industry.
The NRC will require approximately 2031 labor hours (1.4 FTE) to develop a final rule and
update guidance. The NRC would develop the final rule following the close of the public
comment period for the proposed rule. The effort to develop the final rule and update the
guidance is modeled as a one-time labor cost.
•

It is assumed that CRCPD will update Part T to the Suggested State Regulations for Control
of Radiation, which addresses the requirements of 10 CFR Part 71. It is assumed that this
effort will take approximately 2 FTE. It is assumed that in addition to supporting the
development of the Suggested State Regulations for Control of Radiation, the Agreement
States will average about 444 labor hours (0.25 FTE) each to review proposed rule
language and to amend regulations consistent with the final rule. An estimate of 16,428
labor hours for all 37 Agreement States is made and modeled as a one-time labor cost.

•

No quantitative costs or benefits accrue to industry as a result of the Alternative 2 regulatory
changes.
12

The input assumptions for Alternative 2 are in Appendix 1.
3.2.3

Specific Assumptions for Alternative 3

Under Alternative 3, the NRC would make the changes identified above for Alternative 2 and
other conforming changes. The specific assumptions for Alternative 3 are listed below.
•

The proposed changes to 10 CFR 71.15(d) would revise the exemption that applies to
uranium enriched to a maximum of one percent to require the material to be distributed
homogeneously and not form a lattice arrangement. The type of material that would be
affected by this change is more likely to be possessed by the DOE than by a licensee. It is
not typically shipped. Therefore, it is assumed that only the DOE would ship this material.
o

Shipments of material that would be affected by the changes to the fissile
material exemption for uranium enriched to a maximum of one percent are
unlikely and estimated to occur once every 10 years. Accordingly, the NRC
estimates there will be one shipment in the 10-year period. It is assumed that
this shipment would occur midway through the analysis period.

o

The effect of this amendment would be to preclude uranium enriched to a
maximum of one percent that is not distributed homogeneously or that forms a
lattice arrangement from being shipped under the fissile material exemption. It
is assumed that the material would be able to be shipped under a general license
for fissile material, which would require the calculation of the CSI and appropriate
labeling, and on an exclusive use conveyance. It is estimated that the labor
associated with determining the appropriate CSI, which involves determining the
mass of fissile materials for the shipment, and labeling would take 40 hours. It is
assumed that the CSI would not exceed 100, so the shipment would not need to
be shipped using separate conveyances.

•

The NRC is proposing to amend 10 CFR 71.38 to remove the need for QA program
approvals to be renewed. These proposed changes would result in a savings for the NRC,
general licensees, and holders of, or applicants for, a CoC. These are related to changes to
10 CFR 71.106.

•

It is estimated that an average of 25 QA program approvals would not be required each
year. Holders of the QA program approval would not need to prepare a request for a
renewal, because the NRC will be issuing QA program approvals that will not expire for all
existing QA program approvals. It is estimated that each renewal request takes about 20
hours to prepare. The estimated total annual savings for holders of a QA program approval
would be 500 labor hours (or $36,600). The NRC estimates that it averages 10 hours of
effort per renewal.

•

Existing QA program approvals will expire. The NRC would need to issue new QA program
approvals that would not have an expiration date. The NRC estimates that issuing the
replacement QA program approvals would require 40 hours to complete.
The NRC is proposing to add requirements to make it more efficient for holders of a QA
program approval to make changes to their QA program that do not reduce their
commitments to the NRC.
13

•

•

o

The proposed requirements in 10 CFR 71.106(a) would result in a savings for
holders of a QA program approval and the NRC. Holders of a QA program
approval would no longer be required to obtain prior NRC approval for changes
to their QA program description that do not reduce their commitments to the
NRC. The NRC estimates that 14 holders of QA program approvals would
benefit from the proposed amendments each year. It is estimated that, on
average, 25 labor hours would be saved each time a QA program approval
holder does not need to obtain prior NRC approval for their changes. It is
estimated that the NRC takes 5 hours to review each request.

o

The proposed amendments in 10 CFR 71.106(b) would require that respondents
periodically report changes that they made that did not reduce their commitments
to the NRC. The NRC estimates 250 entities will be affected every 2 years. The
NRC estimates that QA program approval holders will spend 1 hour every
2 years to comply with this proposed requirement. The NRC estimates it will
spend 1 hour to review each submittal.

o

Holders of a QA program approval would be required to maintain records created
in response to the proposed changes to § 71.106. The NRC estimates that each
QA program approval holder would spend 0.5 hours annually to maintain these
records.

There will be a one-time labor cost for the NRC and the Agreement States to implement
Alternative 3. It is assumed that implementing Alternative 3 would require 50 percent more
staff hours than the effort required to implement Alternative 2. This means about 3,047
labor hours will be required of the NRC and about 24,642 labor hours by the Agreement
States. This is modeled as a one-time labor cost.
The estimates for the effect of each change for Alternative 3 are in Appendix 2.

3.2.4

Data on Affected Entities

The analysis makes the following assumptions regarding the entities affected:
•

The NRC staff estimates 290 entities ─ 210 general licensees or users of packages,
40 certificate holders/applicants for certificate holders, 37 Agreement States, DOE, DOT,
and CRCPD ─ would be directly impacted by the proposed amendments. The CRCPD
impacts ─ development of Suggested State Regulations for Control of Radiation ─ would
be a subset of, and considered as part of, the Agreement State impacts, because it would
be Agreement State staff working to develop the Suggested State Regulations for Control
of Radiation.

The NRC staff would develop the rule package and revise guidance to accommodate the
requirements that would be added or modified by the rulemaking process.
4. PRESENTATION OF RESULTS
This section presents results of values and impacts that are expected to be derived from the
proposed rule. The results are shown for each of the following attributes:
14

•
•
•
•
•

Industry Operation
Industry Implementation
NRC Implementation
NRC Operation
Other Government Implementation (Agreement States)

The rule is expected to provide values in other attributes, such as Improvements in Knowledge,
Regulatory Efficiency, Environmental Considerations, and Public Confidence, but these are not
quantified because they are expected to be small. The quantified values are presented in
constant 2012 dollars, for both implementation and annual operating expenses. The impact of
the proposed rule over a 10 year analysis period is estimated using 3 percent and 7 percent real
discount rates to show an overall effect in terms of 2012 dollars. Alternative 1, the No-Action
Alternative, provides a baseline against which the other two alternatives are assessed.
4.1

Summary of Results

This section presents results of the benefits and costs that are expected to be derived from the
proposed rule. To the extent that the affected attributes could be analyzed quantitatively, the
costs have been calculated and are presented below. Some values and impacts are addressed
qualitatively for reasons discussed in Section 3.2. Exhibits 3-1 and 3-2 summarize these
results.
Table 4-1 presents the net impact of the proposed rule for each of the three alternatives, at
3 percent and 7 percent real discount rates, including all benefits and costs over the 10-year
analysis period. A positive value for net impact is a cost.
Table 4-1: Net Impact of Alternatives 1, 2, and 3
3 percent discount rate

7 percent discount rate

Alternative 1

$0

Alternative 1

$0

Alternative 2
Alternative 3

$1,008,576
$1,142,677

Alternative 2
Alternative 3

$1,104,488
$1,344,380

There are no costs or benefits associated with Alternative 1, the No Action Alternative. The
estimated cost of approximately $1 million (3 percent discount rate) for Alternative 2 is to
implement the proposed rule in NRC and Agreement State regulations as well as a small
industry shipping savings.
Alternative 3 includes the costs in Alternative 2 and the NRC initiated changes resulting in a
small overall cost savings over the 10-year analysis period. The major contributing costs and
benefits under Alternative 3 are due to:
•

The removal of the requirement to submit QA related information to the NRC, which the
NRC does not need, equal to an annual industry savings of approximately $50,000.

•

As a result of removing the requirements to submit QA information, the NRC will save
approximately $20,000 annually in operating expenses.
15

The cost to the NRC and Agreement States to implement amended regulations is about 50
percent higher for Alternative 3 compared to Alternative 2 because of the larger scope of
activity.
Table 4-2 shows the estimated costs and benefits, by attribute, over the 10-year analysis period
for Alternative 1, 2, and 3 at a three percent discount rate.
Table 4-2: Estimated Values and Impacts by Attribute for Alternative 1, 2 and 3
Alternative 1

Alternative 2

Alternative 3

Industry
Implementation

$0

$95,136

$95,136

Industry Operation

$0

-$543,033

-$954,207

NRC Implementation

$0

$241,689

$367,365

NRC Operation

$0

$0

-$187,792

Agreement States

$0

$1,214,784

$1,822,176

Total

$0

$1,008,576

$1,142,677

Table 4-3 summarizes the costs by entity, over a 10-year analysis period.
Table 4-3: Summary of Values and Impacts for Alternatives 2 and 3
Alternative 3

Industry Costs
Agreement States
NRC Costs
Total

One-time
Implementation
Costs

Annual
Operating
Costs

Total Combined
Implementation and
Annual Cost for 10year period at 3%

Total Combined
Implementation and
Annual Cost for 10year period at 7%

$95,136
$1,822,176
$367,365
$2,284,677

-$111,862
$0
-$22,015
-$133,877

-$859,071
$1,822,176
$179,573
$1,142,677

-$690,537
$1,822,176
$212,741
$1,344,380

One-time
Implementation
Costs

Annual
Operating
Costs

Total Combined
Implementation and
Annual Cost for 10year period at 3%

Total Combined
Implementation and
Annual Cost for 10year period at 7%

$95,136
$1,214,784
$241,689
$1,551,849

-$63,660
$0
$0
-$63,660

-$447,897
$1,214,784
$241,689
$1,008,576

-$351,985
$1,214,784
$241,689
$1,104,488

Alternative 2

Industry Costs
Agreement States
NRC Costs
Total

16

Table 4-4 shows all of the amendments that are included in the proposed rule, and whether or
not the amendment is estimated as a cost (or savings) to industry and to regulators, or is
insignificant and not included in the cost-benefit calculations.
Table 4-4: Proposed Rule Amendments and Significance in the Cost-Benefit Analysis

10 CFR Part 71 Proposed Amendment Description

71.0

71.4

71.6

Purpose and Scope. A section is
deleted from the list of sections for
which general licenses are issued
without a required NRC package
approval.
Definitions. Add definition of
“contamination.” Revise definitions of
“Criticality Safety Index (CSI),” “Low
Specific Activity (LSA) material,”
“special form radioactive material,”
and “uranium ─ natural, depleted,
enriched.”
Information Collection Requirements:
OMB Approval. A new section that
would have an information collection
would be added.

17

Cost of
amendment
estimated as a
licensee and/or
NRC cost and
included in costbenefit analysis

Cost of amendment
NOT estimated as
a licensee and/or
NRC cost and NOT
included in costbenefit analysis
●

●

●

71.14(a)(2) and
(3)

71.15(d)

71.17(c)

71.19(a)

71.21(a)

71.21(d)

Exemption for low-level materials.
The exemption for natural material
and ores containing naturally
occurring radionuclides would be
revised to include material that has
been processed, but is not intended to
be processed for the use of the
radionuclides. A reference to Table
A-3 would be added. An exemption
would be added for non-radioactive
solid objects which have radioactive
substances present on it surfaces,
provided that the quantity of
radioactive substances are below the
quantity used to define contamination.
Exemption for classification as fissile
material. The exemption that applies
to uranium enriched to a maximum of
one percent would be revised to
require the material to be distributed
homogeneously and not form a lattice
arrangement.
General license: NRC-approved
package. Would be revised to clarify
that the general licensee must comply
with the requirements in paragraphs
(c)(1) through (c)(3).
Previously approved package.
Paragraphs would be redesignated
and paragraph (b)(2), which would be
redesignated as paragraph (a)(2),
would be changed to delete the
phrase "December 31, 2003".
General license: Use of a foreign
approved package. This paragraph
would be revised to update the
reference to 49 CFR 171.12.
General license: Plutonium-beryllium
special form material. This paragraph
would be revised to clarify that the
general licensee must comply with the
requirements in paragraphs (d)(1) and
(d)(2).

18

●

●

●

•

●

●

71.31 (b)
71.38

71.70

71.75(a)(5)

71.75(b)(2)

71.75(d)

71.85

Contents of application. Would be
revised to update a reference to
another section.
Renewal of a certificate of
compliance. Would be retitled and
revised to remove references to
renewals of quality assurance
program approvals, which would no
longer be necessary.
Incorporation by reference. This
section would be added to consolidate
the incorporation by reference
language; the costs associated with
the consensus standards that would
be incorporated by reference are
discussed as part of 10CFR 71.75.
Qualification of special form
radioactive material. Would
incorporate by reference ISO 9978 for
the alternate leak test methods.
Qualification of special form
radioactive material. Paragraphs
(b)(2)(ii) and (b)(2)(iii) would be
revised to make corrections in the
description of the billet and the lead
sheet.
Qualification of special form
radioactive material. Would
incorporate by reference the alternate
Class 4 impact test and Class 6
temperature test and would allow the
Class 5 impact tests to be used if the
specimen weighs less than 500
grams.
Preliminary determinations. Would be
revised to make certificate holders
responsible for making preliminary
determinations and durably marking
the package. Licensees would be
responsible for ensuring that the
preliminary determinations have been
made.

19

●
●

●

●1

●

●2

•

●3

71.91(a)
71.101(a)

71.101(c)(2)

71.103(a)
71.106

71.135

Appendix A,
paragraph IV
Appendix A,
paragraph V

Records. Would correct the reference
from 10 CFR 71.10 to 10 CFR 71.14.
Quality assurance requirements.
Would clarify the responsibilities of
certificate holders and licensees to
reflect the activities that they conduct
and would clarify when the NRC is to
be notified that a previously approved
quality assurance program is to be
applied to transportation activities.
Quality assurance requirements.
Would clarify that this section only
applies to certificate holders and
applicants.
Quality assurance organization.
Would delete a footnote, which is
considered unnecessary.
Changes to quality assurance
program. Would be added to revise
the process for obtaining NRC
approval to make changes to an
approved quality assurance program
and to report to the NRC those
changes that do not require prior NRC
approval.
Quality assurance records. This
section would be revised to include
changes made to an approved quality
assurance program as a quality
assurance record.
Determination of A1 and A2.
Clarifications and corrections would
be made to the process for calculating
values for A1 and A2.
Determination of A1 and A2. Direction
would be provided for calculating
exempt activity concentration and
exempt consignment activity for
certain mixtures of radionuclides.

20

●
●

●

●
●

●

●

●

Appendix A,
Table A-1
Appendix A,
Table A-2

Appendix A,
Table A-3

A1 and A2 Values for Radionuclides.
Would be revised by adding entries,
revising entries, and revising
footnotes.
Exempt Material Activity
Concentrations and Exempt
Consignment Activity Limits for
Radionuclides. Would be revised by
adding an entry for Kr-79, revising the
entry (values) for Te-121m, and
revising footnote b.
General Values for A1 and A2. Would
be revised to clarify the descriptive
phrases for the contents and add a
footnote to clarify the calculation of A1
for a group containing both alpha
emitting radionuclides and beta or
gamma emitting radionuclides when
the groups are based on the total
alpha activity and the total beta and
gamma activity.

●

●

●

1

The alternate tests allowed by the incorporation by reference are more stringent and costly to perform
than the tests prescribed in 10CFR 71.75. Because they are alternative approaches and current practice
is to use the tests prescribed in 10 CFR 71.75(c), it is estimated that there are no costs associated with
this change.
2

The alternate tests allowed by the incorporation by reference are more stringent and costly to perform
than the tests prescribed in 10 CFR 71.75(b)(1) and (2). Because they are alternative approaches and
current practice is to use the tests prescribed in 10 CFR 71.75, it is estimated that there are no costs
associated with this change, with the exception of the alternate test allowed for specimens weighing less
than 500 grams. The added flexibility for the test for specimens weighing less than 500 grams may have
additional benefits and may be more likely to be used. The costs/benefits for this test have been
estimated for this RA.
3

The changes to the preliminary determinations involve changes that would reflect that package marking
and testing is done by certificate holders, rather than the user of the package. Licensees would be
required to ensure that the preliminary determinations have been made. The changes do not change the
preliminary determinations that are to be performed before the first use of the package, so it is estimated
that there will be no costs associated with these changes, which also reflect current industry practice.

21

5. DECISION RATIONALE
The assessment of costs and benefits discussed previously leads the NRC to the conclusion
that the proposed rule, if implemented, would improve regulatory efficiency and effectiveness for
transportation of radioactive material, and would benefit industry with small changes to
measures of public health and safety. There is a need to amend regulations to achieve
compatibility with the IAEA’s TS-R-1 safety standards. Finally, there is a benefit to amend the
regulatory requirements that result in holders of a QA program approval having to submit all
changes to their QA program description to the NRC for prior approval. Under the proposed
rule, holders of a QA program approval would only need to submit to the NRC changes to their
QA program description if the change would result in a reduction in the commitments that they
have made to the NRC.
Three alternatives were evaluated in this RA. Alternative 1 would take No Action and would
maintain the regulations as currently written.
Alternative 2 would amend regulations to provide compatibility with the IAEA’s TS-R-1 safety
standards and with changes proposed by the DOT. These changes can be done through
rulemaking with a one-time implementation cost to the NRC, Industry, and the Agreement
States equal to about $1.5 million followed by an annual operating cost savings of
approximately $63,000.
Alternative 3 would amend regulations as described in the proposed rule. These amendments
would provide compatibility with IAEA and DOT regulations and would make certain
NRC-initiated regulatory changes to improve regulatory efficiency and to provide benefits to
licensees and to the NRC and Agreement States with a small change to measures of impacts to
public health and safety. The implementation cost would be equal to approximately $2,284,000
followed by an annual savings to industry of an estimated $112,000 (in 2012 dollars). The NRC
has determined that Alternative 3 is superior to either of the other alternatives, and improves
regulatory efficiency.
6. IMPLEMENTATION
The proposed rule is planned for publication in the Federal Register in November 2012.
Following a public comment period and several months to review the public comments, the NRC
staff will revise the proposed rule as appropriate and submit to the Commission in 2013 a
proposed final rule.

22

7. REFERENCES
•

SECY-01-0057, dated March 29, 2001, (ADAMS Accession No. ML010810303), and
Attachment 2, “NORM and TENORM Producers, Users, and Proposed Regulations” by P.
Egidi and C. Hull, Table 5A, Page 16 (ADAMS Accession No. ML010670073).

•

IAEA Safety Standards Series. IAEA SSR-6, 2012, “Regulations for the Safety Transport of
Radioactive Material,” IAEA, Vienna.

•

IAEA Safety Standards Series. IAEA TS-R-1, Amended 2009, “Regulations for the Safe
Transport of Radioactive Material,” IAEA, Vienna.

•

NRC, “RA Technical Evaluation Handbook, Final Report,” NUREG/
BR-0184, January 1997.

•

U.S. Department of Labor, Bureau of Labor Statistics. Occupational Employment Statistics,
Occupational Employment and Wages.

•

DOE, “A Resource Handbook on DOE Transportation Risk Assessment,” DOE/EM/NTP
/HB-01, July 2002.

•

DOE, “Questions and Answers About Transportation of Radioactive Materials by DOE,”
http://www.em.doe.gov/PDFs/transPDFs/Questions_Answers_About_Transportation_Radio
active.pdf.

•

DOT, “The U.S. Department of Transportation’s Comprehensive Truck Size and Weight
Study: Volume II: Issues and Background,” FHWA-PL-00-029 (Volume II), HPTS, August
2000.

•

National Conference of State Legislatures, “Table of State Permits and Fees (Annual) for
the Transportation of Radioactive Materials,” http://www.ncsl.org/issues-research/envres/transportatoin-of-radioactive-materials-fees.aspx, January 2010.

•

Tsurikov, N., Hinrichsen, P.J., Omar, M., Fernandes, H.M., “Regulation of Natural
Radioactivity in International Transport and Trade,” presented at the Second Asian and
Oceanic Congress on Radiological Protection, Beijing, People’s Republic of China, 2006.

•

Tsurikov, N., “The Trade in Radioactive Materials – Potential Problems and Possible
Solutions,” NORM-V Proceedings, IAEA, 2008.

•

Schwela, U. and Chambers, D., “Transportation of Tantalum Raw Materials, Other NORM,
and Waste,” presented at the EAN-NORM 2nd Workshop, Dresden, http://www.eannorm.net/lenya/ean_norm/images/pdf/Transport_tantalum_raw_materials_NORM_waste_Sc
hwela_Chambers.pdf, Germany, 2009.

•

U.S. Geological Survey, 2011, Mineral commodity summaries 2011: U.S. Geological Survey.

23

•

L.D. Cunningham, "Columbium (Niobium) and Tantalum," Minerals Yearbook Volume 1.
Metals and Minerals, U.S. Bureau of Mines, 1992, pp. 435-436.

24

Appendix 1: Input Assumptions and Line Item Results relating to Alt
2
NRC effort to develop final rule and amend
guidance
Agreement States’ effort to develop final
rule and amend guidance

•

Hours

$ Per Hour

Total One-time Cost (2012)

2031

119

$241,689

19,980

60.80

$1,214,784

37 Agreement States X 444 hours (.25) gives us the AS hours plus and additional 3,552 hours for the CRCPD efforts.

Truck Shipments/Year

Licensee Cost or Savings to
Comply with Transportation
Regulations
($/truck shipment)

Annual Cost of
Shipments (20121$)

5

(500)

(2,500)

kr-79

25

(500)

(12,500)

kr-81

0

0

0

mo-99

0

0

0

kr-79

25

(100)

(2,500)

kr-81

0

0

0

Te-121m

25

(100)

(2,500)

Change

Table A-1
cf-252
lr-192

Table A-2

Totals

(20,000)

25

Detailed Quantitative Results relating to Licensee Costs/Savings
for Alt 2

Number
Licensees

Citation

Description

71.14(a)

Natural material/ore could be
shipped without being classified as
hazardous material if it meets the
expanded exemption.

5

Purchase copy of ISO standards.

250

Annual
Responses

Cost per
Shipment/Hours
Per Response

Annual
hours
per
change

Total
Annual
Cost

One
Time
Cost

Total 10
Year 3%
NPV

Total 10
Year 7%
NPV

-$341,208

-$280,943

ALTERNATIVE # 2
80

-500

-$40,000

$50,000

Maintain awareness of changes to
the relevant transportation
regulations.

71.75(d)

$7,500

240 licensees will need to read the
new regulations and will determine
actions necessary

240

240

2

480

Would incorporate by reference the
alternate Class 4 impact test and
Class 6 temperature test and would
allow the Class 5 impact tests to be
used if the specimen weighs less
than 500 grams.

50

-50

1

-50

Appendix
A
Total Alternative 2

26

$35,136

-$3,660

$2,500

-$31,221

-$25,706

-$20,000

$0

-$170,604

-$140,472

-$63,660

$95,136

-$543,033

-$447,121

+one
time
cost

$95,136

$95,136

TOTAL

-$447,897

-$351,985

Appendix 2: Detailed Quantitative Results relating to Licensee and
NRC Costs/Savings for Alt 3
Licensee

Citation

Description

Number
Licensees

Annual
Responses

Hours Per
Response

Annual
hours
per
change

Total
Annual
Cost

One
Time
Cost

Total 10
Year 3%
NPV

Total 10
Year 7%
NPV

ALTERNATIVE # 3
71.15(d)

*Revises the exemption that applies
to uranium enriched to a maximum
of 1 percent.

1

0.1

40

4

$293

$0

$2,498

$2,057

71.38(c)

Renewal of a CoC would be revised
to remove references to renewals of
QA program approvals, which would
no longer be necessary.

25

-25

20

-500

-$36,600

$0

-$312,205

-$257,063

71.106(a)

Allows certificate holders and
applicants for a COC to make
changes to their approved QA
program if the changes do not
reduce the commitments in the QA
program previously approved by
NRC.

14

-14

25.00

-350

-$25,620

$0

-$218,544

-$179,944

71.106(b)

Changes to quality assurance
program. Added to revise the
process for obtaining NRC approval
to make changes to an approved
quality assurance program and to
report to the NRC those changes
that do not require prior NRC
approval

250

125

1.00

125

$9,150

$0

$78,051

$64,266

71.135

Recordkeeping

250

125

0.5

63

$4,575

$0

$39,026

$32,133

TOTAL

-$954,207

-$785,673

+ onetime
costs

$95,136

$95,136

TOTAL

-$859,071

-$690,537

$95,136
-$111,862

Total Alternative # 3

1

Note Alternative 3 includes all cost and benefits for “Alternative 2” in Appendix 1.

27

NRC Alternative # 3

Citation

Description

Number
Licensees

Response
Per Year

Total
Annual
Responses

Labor
Hours Per
Response

RA rule prep
Alternative 3
71.38

Issue new QA
program
approvals.

71.38( c)

Review
renewals of
QA program.

71.106 (a)

71.106(b)

Holders of a
QA Program
Approval
would no
longer be
required to
obtain prior
NRC approval
of changes to
their QA
program
description
that do not
reduce their
commitments
to the NRC.
Report to the
NRC those
changes that
do not require
prior NRC
approval.

Total
Annual
Costs

One Time
Cost Per

Total 10 Yr 3
Percent NPV

Total 10 Yr
7 percent
NPV

$0

$362,605

$362,605

$362,605

$4,760

$4,760

$4,760

240

0

0

0.17

$0

24

(1)

(24)

10

-$28,560

$0

-$243,623

-$200,593

14

(1)

(14)

5

-$8,330

$0

-$71,057

-$58,506

125

1

125

1

$14,875

$0

$126,887

$104,476

$179,573

$212,741

Total One
Time Cost
$367,365
-$22,015

28

TOTAL