Download:
pdf |
pdfRegulatory Analysis for Final Rulemaking - Compatibility with IAEA
Transportation Standards (10 CFR Part 71)
September 2014
Table of Contents
EXECUTIVE SUMMARY
iii
ACRONYMS
iv
1.
STATEMENT OF THE PROBLEM AND OBJECTIVE OF THE RULEMAKING
1
2.
IDENTIFICATION OF ALTERNATIVE APPROACHES
2
2.1
Alternative 1: The No-Action Alternative
2
2.2
Alternative 2: IAEA-DOT Compatibility
2
2.3
Alternative 3: IAEA-DOT Compatibility and NRC-Initiated Changes
3
3. ESTIMATION AND EVALUATION OF BENEFITS AND COSTS
4
3.1
Identification of Affected Attributes
4
3.2
Analytical Methodology
6
3.2.1
General Assumptions
7
3.2.2
Specific Assumptions for Alternative 2
8
3.2.3
Specific Assumptions for Alternative 3
10
3.2.4
Data on Affected Entities
12
4.
PRESENTATION OF RESULTS
12
4.1
Summary of Results
13
4.2
Backfitting
15
5. DECISION RATIONALE
15
6. IMPLEMENTATION
16
7. REFERENCES
16
Appendix 1 Alternative 2 Licensee costs
18
Appendix 2: Alternative 3 Costs
19
EXECUTIVE SUMMARY
The U.S. Nuclear Regulatory Commission (NRC) regulates the safe transportation of byproduct
material under Part 71 of Title 10 of the Code of Federal Regulations (10 CFR), “Packaging and
Transportation of Radioactive Material.” In consultation with the U.S. Department of
Transportation (DOT), the NRC is amending its regulations for the packaging and transportation
of radioactive material. These amendments will make conforming changes to the NRC’s
regulations based on the International Atomic Energy Agency’s (IAEA) regulations for the
international transportation of radioactive material and to maintain consistency with DOT
regulations. The final NRC rule, in combination with a final DOT rule amending Title 49 of the
Code of Federal Regulations (49 CFR) (79 FR 40590; July 11, 2014), will bring United States
regulations into general accord with the 2009 edition of the IAEA’s “Regulations for the Safe
Transport of Radioactive Material” (TS-R-1).
In addition, the NRC is making other revisions to 10 CFR Part 71. These other revisions include
NRC-initiated changes that will: 1) update administrative procedures for the quality assurance
(QA) program requirements described in subpart H of 10 CFR Part 71; 2) re-establish
restrictions on material that qualifies for the fissile material exemption; 3) clarify the
requirements for a general license; 4) clarify the responsibilities of certificate holders and
licensees when making preliminary determinations; and 5) make other editorial changes.
This Regulatory Analysis (RA) provides an evaluation of three alternatives. The preferred
alternative is Alternative 3 (see Section 2.3 of this document), which will change regulations as
specified in the rule.
The RA makes the following key findings:
•
Total cost to Industry: The rule will result in a one-time cost to the industry of
approximately $95,000 (approximately $400 per licensee). The rule will have a
total annual savings to the industry of approximately $112,000 (approximately
$450 per licensee).
•
Total cost to the NRC: The rule will result in a one-time cost to the NRC of
approximately $5,000, followed by annual cost savings of approximately $22,000.
•
Total cost to Agreement States: Agreement States will be required to amend
their regulations consistent with the final rule. The rule will result in a one-time
cost to Agreement States of approximately $1.8 million.
•
Decision Rationale: The final rule will make the NRC’s Part 71 requirements
compatible with IAEA and DOT regulations. The NRC-initiated regulatory
changes will improve regulatory efficiency, thereby providing benefits to
licensees and to the Agreement States. The final rule is expected to slightly
reduce impacts to public health and safety.
The final rule is planned for publication in the Federal Register in 2015.
iii
ACRONYMS
ADAMS
AS
CFR
CRCPD
CoC
CSI
DOE
DOT
FTE
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
Full Time Equivalent
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” 2009 edition
iv
1.
STATEMENT OF THE PROBLEM AND OBJECTIVE OF THE RULEMAKING
The NRC is amending its 10 CFR Part 71 regulations for packaging and transportation of
radioactive material. These amendments will make NRC regulations consistent with 2009
revisions to the IAEA’s transportation standards in TS-R-1. The TS-R-1 represents an accepted
set of requirements that provides a high level of safety in the packaging and transportation of
radioactive materials and provides 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 can reduce risks associated with the import and export of
radioactive material.
The IAEA revises its transportation standards periodically to reflect acquired knowledge and
experience. The NRC periodically updates its transportation regulations in10 CFR Part 71 to
reflect the changes in the IAEA’s transportation standards and to maintain compatibility with the
DOT regulations.
The NRC co-regulates domestic transportation of radioactive material with the DOT. The
DOT regulations regarding transportation of radioactive materials are in Title 49 Parts 107,
and 171-180. The NRC and the DOT are publishing final rules with the dual purpose to
achieve compatibility with IAEA’s transportation standards and to improve regulatory efficiency
by maintaining a consistent regulatory framework. To achieve compatibility with TS-R-1, the
DOT published amendments to its regulations in a final rule dated July 11, 2014 (76 FR
40590). The NRC is also making other changes that do not affect compatibility with the IAEA
TS-R-1 or the DOT hazardous material regulations, as discussed in more detail later in this
document.
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 NRC rulemaking does not incorporate the 2012 IAEA SSR-6 changes. The NRC will
review the SSR-6 changes to determine if additional future conforming changes to 10 CFR
Part 71 are warranted.
In addition to making changes for compatibility with IAEA and DOT, the NRC is also revising
10 CFR Part 71 to: 1) update administrative procedures for the quality assurance program
requirements described in subpart H of 10 CFR Part 71; 2) re-establish restrictions on material
that qualifies for the fissile material exemption; 3) clarify the requirements for a general license;
4) clarify the responsibilities of certificate holders and licensees when making preliminary
determinations; and 5) make editorial revisions to correct and clarify certain other requirements.
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 requirements 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."
1
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. The NRC and the DOT harmonized domestic
transport regulations with changes made to TS-R-1 over the past several years. These
changes will be implemented with a slight cost to the public and domestic regulatory authorities
responsible for implementing the proposed changes.
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.
This analysis presents background material, rulemaking objectives, alternatives considered,
input assumptions, analysis of the costs and benefits of the proposed rule, and decision
rationale. It describes the consequences of the rule language and alternative approaches
necessary to accomplish the regulatory objectives.
2. IDENTIFICATION OF ALTERNATIVE APPROACHES
The following sections describe the regulatory options that the NRC considered in order to meet
the rulemaking objectives identified in the previous section. The NRC considered three
alternatives for the rule, described in the following sections. The full lists of changes that
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
Alternative 1 is the No-Action alternative and would maintain the status quo. Under Alternative
1, 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 rule would impose;
however, it would allow greater divergence between the international standards and the
domestic regulations. Because radioactive material is routinely imported and exported,
consistency between domestic and international transportation regulations benefits international
commerce. Differences in domestic and international regulations can make it more complicated
and expensive to import or export radioactive material and inhibit trade. Under this alternative,
there would be no changes to 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 TS-R-1 and with changes implemented by the DOT and does not include any additional
NRC-initiated changes. These amendments include:
2
•
Section 71.4, Definitions. A definition of contamination is added, and the existing
definitions of “Criticality Safety Index (CSI),” “Low Specific Activity (LSA) material,”
“special form radioactive material,” and “Uranium ─ natural, depleted, enriched” are
revised.
•
Section 71.14, Exemption for low-level material. Paragraph (a) is revised to allow natural
material and ores that contain naturally occurring radionuclides to qualify for the
exemption, if such material has “been processed for purposes other than the extraction
of the radionuclides.” Section 71.14(a)(3) is added to provide an exemption for nonradioactive solid objects which have radioactive substances present on their surfaces,
provided that the quantity of radioactive substances is below that which is stated in the
new contamination definition.
•
Section 71.75, Qualification of special form radioactive material. Paragraph (d) is
amended to update the International Organization for Standardization (ISO) Class 4
impact test and ISO Class 6 temperature test to those prescribed in ISO 2919:1999(E),
“Radiation protection — Sealed radioactive sources — General requirements and
classification,” and will 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 is amended to
add an entry for krypton-79 (Kr-79); revise listed values for californium-252 (Cf-252), and
revise footnotes to be consistent with TS-R-1.
•
Appendix A, Table A-2, “Exempt Material Activity Concentrations and Exempt
Consignment Activity Limits for Radionuclides.” The table is amended to add an entry
for Kr-79, revise listed values for tellurium-121m (Te-121m), and revise footnote b.
2.3
Alternative 3: IAEA-DOT Compatibility and NRC-Initiated Changes
This alternative includes all of the changes comprising Alternative 2 and additional NRC-initiated
changes.
These NRC-initiated changes include:
•
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) is
revised to additionally require that such material be distributed homogeneously and not
form a lattice arrangement, in order to qualify for this exemption.
•
Section 71.38, Renewal of a certificate of compliance. This section is retitled and
revised to remove references to renewals of QA program approvals, which will no longer
be required.
3
•
Section 71.85, “Preliminary determinations.” This section is revised to replace
“licensee” with “certificate holder” in paragraphs (a), (b), and (c); and paragraph (d) is
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 is added to
revise the process for holders of a QA program approval to make changes to an
approved QA program and requires periodic reporting of those changes that do not
require prior NRC approval.
•
Section 71.135, “Quality assurance records.” This section is 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. They 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 BENEFITS AND COSTS
This section examines the benefits and costs expected to result from the 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 amendments.
3.1
Identification of Affected Attributes
This section identifies the factors within the public and private sectors that the final rule is
expected to affect, using the list of potential attributes in Chapter 5 of NUREG/BR-0184,
“Regulatory Analysis Technical Evaluation Handbook,” issued January 1997, and in Chapter 4
of NUREG/BR-0058, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission,” Revision 4, issued September 2004. This evaluation considered each attribute
listed in Chapter 5 of NUREG/BR-01841. The basis for selecting those attributes is presented
later in this document.
Affected attributes include the following:
•
1
Industry Operation: The NRC is making changes that will make the regulation of QA
programs more efficient. The NRC will issue QA program approvals that will not expire, so
that QA program renewal applications will no longer be required. The NRC is also allowing
those changes that do not reduce the commitments in an approved QA program to be made
without prior NRC approval. Additional natural material and ores that contain naturally
occurring radionuclides might qualify for the exemption of low-level radioactive material,
which will facilitate the transportation of these materials and reduce shipping costs. In
aggregate, the NRC expects that the efficiencies gained from these regulatory changes will
result in cost savings to the industry. Radioactive material is imported and exported and
consistency between domestic and international transportation regulations reduces cost to
the industry. This rule will allow industry to continue to benefit from harmonized regulations.
(http://pbadupws.nrc.gov/docs/ML0501/ML050190193.pdf)
4
•
Industry Implementation: When the final rule is adopted/promulgated, affected licensees
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 for compliance. Changes to 10 CFR 71.75(d),
which will 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 affected licensees to incur a one-time cost for the purchase of
equipment.
•
NRC Implementation: With the publication of the final rule, the NRC will re-issue QA
program approvals with no expiration date. The NRC will 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.
•
Other Governments: Agreement States will 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 States
will incur one-time costs to amend regulations to implement Alternative 2 or Alternative 3.
The U.S. Department of Energy (DOE) certifies its packages, and it 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
for shipment in a manner equivalent to that required of NRC licensees. Consequently,
the DOE will need to comply with amendments to the fissile material exemption.
•
Regulatory Efficiency: The 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 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 will 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 will 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 rule modifies 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 will not need to apply to renew their approval and the
NRC will not have to review future renewals of QA program approvals. With the publication
of a final rule, the NRC will re-issue QA program approvals with no expiration date.
•
Environmental Considerations: The amendments will 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 will increase
the number of shipments of low specific activity radioactive material that will be exempt from
5
the NRC and the DOT transport regulations (i.e., will 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 environmental impacts, the NRC determined
that there will be no significant impact to the public from the amendments.
•
NRC Operations: Since QA program renewal applications will no longer be required,
holders of a QA program approval will not need to apply to renew their approval, thereby
reducing the expenditure of NRC resources needed to review such applications. With the
publication of a final rule, the NRC will re-issue QA program approvals with no expiration
date. The NRC will need to review the biennial reports of changes to QA programs that do
not reduce commitments to the NRC. The action will result in a small annual savings to the
NRC in the oversight of QA programs.
The following attributes are not expected to be affected:
Public Health (Accident)
Public Health (Routine)
Antitrust Considerations
Improvements in Knowledge
3.2
Offsite Property
Onsite Property
General Public
Occupational Health (Accident)
Occupational Health (Routine)
Safeguards and Security
Analytical Methodology
This section describes the methodology used to analyze the benefits and costs associated with
the rule. The benefits consist of any desirable changes in the affected attributes. The 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 rule have been identified by the NRC.
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. 42 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
2
( http://www.nrc.gov/reading-rm/doc-collections/nuregs/brochures/br0058/)
6
and 7 percent real discount rates. The 3 percent rate approximates the real rate of return on
longterm 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 RA includes assumptions and estimates. The NRC relied on referenced sources for the
assumptions and estimates when these were available.
3.2.1
General Assumptions
Costs are expressed in 2014 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 2014 discounted back at a 7-percent and 3-percent
discount rate, in accordance with NUREG/BR-0058, Rev. 4.
Here is a discussion of the NRC’s general input assumptions for this analysis.
•
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
amendments. Currently, the NRC hourly labor rate is $121.
•
Licensee labor rates were determined from 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-determined Agreement State labor rates are based on 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., $121/hour.
•
The time period for the analysis is 10 years, because licenses are on a 10-year cycle for
renewals.
•
Estimates were made for one-time implementation costs. It is assumed that the costs
will be incurred in the first year after the rule becomes effective. This will provide a
conservative estimate of the one-time implementation costs, because one-time costs
7
that may occur later (e.g., rulemaking conducted by the Agreement States will not be
discounted).
•
3.2.2
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 will amend the 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 Agreement States.
Appendix 1 details the licensee costs for Alternative 2. The specific NRC assumptions for
Alternative 2 costs are as follows:
•
•
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 will incur costs associated
with this effort. It is estimated that 50 percent of licensees will 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 will be made to review the changes in the
regulations. The rule includes 24 amendments. It is estimated that an average
of 2 hours per licensee or certificate holder will be spent reviewing the changes,
for a total of approximately $35,000.
The changes to § 71.14(a) will 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 will not be shipped
for the use of its radionuclides. Licensees will need to ensure correct labeling and
placarding for their shipments. This will 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 will be unaffected by this change. It is assumed
that about 2 percent of licensees (5 licensees) will 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 estimated annual 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
8
available in the U.S. Geological Survey Mineral Commodity Summaries3 after
being adjusted to better approximate the amount of material affected by the
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 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)4. 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 will
qualify for the exemption, the volume of material and the number of shipments
will include the shipment of some material not specifically evaluated.
o
It is estimated that approximately 12,000 metric tons of material is shipped
annually by rail in approximately 125 railroad cars (or shipments).
o
It is assumed that annual fees and permits will not be affected by this change;
because some material will still be shipped as class 7 (radioactive) hazardous
materials.
o
It is estimated that approximately $500 per shipment will be saved, because the
material will not be shipped as radioactive material.
The NRC is incorporating 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.”5 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
3
It is assumed that each of the 250 impacted licensees will obtain a copy of the
ISO standards. It is also assumed that they will acquire the standards at the nonmember rate. These estimates will be conservative in estimating the costs.
http://minerals.usgs.gov/minerals/pubs/mcs
http://calytrix.biz/papers/07.NORM_trade.pdf
5
(http://pbadupws.nrc.gov/docs/ML0036/ML003686268.pdf)
9
4
Purchasing the two standards from the distributor in the U.S. will cost each
licensee $200 for a total cost of $50,000.
o
The NRC estimates there are 60 Class 4 and 60 Class 6 tests performed 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 will cost $500 for
each licensee who acquires the equipment. It is assumed that 5 licensees will
purchase the equipment, for a total cost of $2,500.
o
It is estimated that licensees will perform 50 Class 5 impact tests each year
instead of the Class 4 impact test at an equivalent savings of the costs for one
labor hour per test, for a total savings of $3,660.
•
Other changes will amend certain values in 10 CFR Part 71, Tables A-1 and A-2. These
changes will result in an estimated net savings of $20,000 annually for the industry.
•
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 rule language and to
amend regulations consistent with the final rule. An estimate of 19,980 labor hours for all 37
Agreement States is made and modeled as a one-time labor cost.
3.2.3
Specific Assumptions for Alternative 3
Under Alternative 3, the NRC will make the changes identified above for Alternative 2 plus other
NRC-initiated changes. Appendix 2 details the additional costs for Alternative 3. The specific
assumptions for Alternative 3 costs are listed below.
•
The changes to 10 CFR 71.15(d) will revise the exemption that applies to uranium enriched
in uranium-235 to a maximum of 1 percent by weight, and with total plutonium and uranium233 content of up to 1 percent of the mass of uranium-235. Within the transportation
packages, the material must be distributed homogeneously and must not form a lattice
arrangement, in order to qualify for the exemption. The type of material that will be affected
by this change is more likely to be possessed by the DOE than by a licensee. Uranium of
this enrichment is not used in commercial power reactors, and therefore is not typically
shipped. Therefore, it is assumed that only the DOE will ship this material.
o
Shipments of material that will be affected by the revised exemption are expected
to be infrequent – one shipment every 10 years. The NRC’s cost estimate is
based on this assumption, and it is further assumed that this shipment will occur
midway through the analysis period.
o
Material which does not meet the revised exemption will likely be able to be
shipped under a general license for fissile material, which will require the
10
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 will take 40 hours. It is assumed that the CSI will not
exceed 100, so the shipment will not need to be shipped using separate
conveyances.
•
The NRC is amending 10 CFR 71.38, and adding a new 10 CFR 71.106, to remove the
need for QA program approvals to be renewed. These changes will result in a savings for
the NRC, general licensees, and holders of, or applicants for, a CoC.
•
Based on these changes, the NRC estimates there will be an average of 25 fewer QA
program approval reviews each year. Holders of the QA program approval will 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 will 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 will need to issue new QA program
approvals that will not have an expiration date. The NRC estimates that issuing the
replacement QA program approvals will require 40 hours to complete for a one-time NRC
cost of approximately $4,800.
•
The NRC is adding 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.
o
The new requirements in 10 CFR 71.106(a) will result in a savings for holders of
a QA program approval and the NRC. Holders of a QA program approval will 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 will benefit from the
amendments each year. It is estimated that, on average, 25 labor hours will 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 new requirements in 10 CFR 71.106(b) will 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 by
these new requirements. The NRC estimates that QA program approval holders
will spend 1 hour every 2 years to comply with this requirement. The NRC
estimates it will spend 1 hour to review each submittal.
o
Holders of a QA program approval will be required to maintain records created in
response to the changes to § 71.106. The NRC estimates that each QA program
approval holder will spend 0.5 hours annually to maintain these records.
11
•
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 will require 50 percent more
Agreement State staff hours than the effort required to implement Alternative 2. This means
about 29,970 labor hours will be required of the Agreement States. This is modeled as a
one-time labor cost.
3.2.4
Data on Affected Entities
The analysis makes the following assumptions regarding the entities affected:
The NRC estimates 290 entities ─ 210 general licensees or users of packages, 40 certificate
holders/applicants for certificate holders, 37 Agreement States, DOE, DOT, and CRCPD ─ will
be directly affected by the amendments. The affects on the CRCPD ─ development of
Suggested State Regulations for Control of Radiation ─ will be a subset of, and considered as
part of, the affects on Agreement States, because it will be Agreement State staff working to
develop the Suggested State Regulations for Control of Radiation.
This rule affects NRC licensees who transport or deliver to a carrier for transport, relatively large
quantities of radioactive material in a single package; holders of a quality assurance program
description issued under 10 CFR parts 50, 71, or 72; and holders of a certificate of compliance
for a transportation package. These companies do not fall within the scope of the definition of
“small entities” set forth in the Regulatory Flexibility Act or the size standards adopted by the
NRC in 10 CFR 2.810, “NRC size standards.”
4. PRESENTATION OF RESULTS
This section presents results of benefits and costs that are expected to be derived from the rule.
The results are shown for each of the following attributes:
•
•
•
•
•
Industry Operation
Industry Implementation
NRC Implementation
NRC Operation
Other Government Implementation (Agreement States)
The rule is expected to provide benefits in Regulatory Efficiency and Environmental
Considerations, but these are not quantified because they are expected to be small.
The quantified benefits are presented in constant 2014 dollars, for both implementation and
annual operating expenses. The impact of the 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 2014
dollars. Alternative 1, the No-Action Alternative, provides a baseline against which the other two
alternatives are assessed. The baseline assumes full compliance with existing NRC
requirements. This baseline is consistent with NUREG/BR-0058, which states that, “in
evaluating a new requirement...the staff should assume that all existing NRC requirements have
been implemented.”
12
4.1
Summary of Results
This section presents results of the benefits and costs that are expected to be derived from the
rule. To the extent that the affected attributes could be analyzed quantitatively, the costs have
been calculated and are presented below. Some benefits and costs are addressed qualitatively
for reasons discussed in Section 3.1.
Table 4-1 presents the net impact of the 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
$766,887
$776,916
Alternative 2
Alternative 3
$862,799
$979,176
There are no costs or benefits associated with Alternative 1, the No Action Alternative. The
estimated cost of approximately $0.8 million (3 percent discount rate) for Alternative 2 is to
implement the 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 as follows:
•
The removal of the requirement to submit QA related information to the NRC, which
equals 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.
Because of the larger scope of activity, the cost to the Agreement States to implement amended
regulations is about 50 percent higher for Alternative 3 compared to Alternative 2.
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 and seven percent discount rate.
13
Table 4-2: Estimated Benefits and Costs by Attribute for Alternative 1, 2 and 3
3% Discount Rate
Alternative 1
Alternative 2
Alternative 3
Industry
Implementation
$0
$95,136
$95,136
Industry Operation
$0
-$543,033
-$954,207
NRC Implementation
$0
$0
$4,760
NRC Operation
$0
$0
-$190,949
Agreement States
$0
$1,214,784
$1,822,176
Total
$0
$766,887
$776,916
7% Discount Rate
Alternative 1
Alternative 2
Alternative 3
$0
$95,136
$95,136
$0
-$447,121
-$785,673
NRC Implementation
$0
$0
$4,760
NRC Operation
$0
$0
-$157,223
Agreement States
$0
$1,214,784
$1,822,176
Total
$0
$862,799
$979,176
Industry
Implementation
Industry Operation
Table 4-3 summarizes the costs by entity, over a 10-year analysis period. Appendices 1, 2 and
3 give details to the results presented in Table 4-2
Table 4-3: Summary of Benefits and Costs for Alternatives 2 and 3
Alternative 2
Industry Costs
Agreement States
NRC Costs
Total
One-time
Implementation
Costs
Annual
Operating
Costs
$95,136
$1,214,784
$0
$1,309,920
-$63,660
$0
$0
-$63,660
14
Total Combined
Implementation and
Annual Cost for 10year period at 3%
-$447,897
$1,214,784
$0
$766,887
Total Combined
Implementation and
Annual Cost for 10year period at 7%
-$351,985
$1,214,784
$0
$862,799
Alternative 3
Industry Costs
Agreement States
NRC Costs
Total
One-time
Implementation
Costs
Annual
Operating
Costs
$95,136
$1,822,176
$4,760
$1,922,072
-$111,862
$0*
-$22,385
-$134,247
Total Combined
Implementation and
Annual Cost for 10year period at 3%
-$859,071
$1,822,176
-$186,189
$776,916
Total Combined
Implementation and
Annual Cost for 10year period at 7%
-$690,537
$1,822,176
-$152,463
$979,176
*Agreement States do not have annual operating cost saving because NRC reviews the QA program
4.2
Backfitting
The NRC has determined that the backfit rule (§§ 50.109, 70.76, 72.62, or 76.76) and the issue
finality provisions in 10 CFR part 52 do not apply to this final rule, because this final rule does
not contain any provisions that will impose backfits as defined in 10 CFR Chapter I. Therefore,
a backfit analysis is not required for this final rule, and the NRC did not prepare a backfit
analysis for this final rule.
5. DECISION RATIONALE
There is a need to amend the NRC’s regulations to achieve compatibility with the IAEA’s TS-R-1
safety standards. The assessment of costs and benefits discussed above leads the NRC to the
conclusion that this final rule will improve regulatory efficiency and effectiveness for
transportation of radioactive material, and will be cost-beneficial to the NRC and industry. The
final rule is expected to slightly reduce impacts to public health and safety.
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 made by the Amending the NRC’s regulations can be done through
rulemaking with a one-time implementation cost to the NRC, Industry, and the Agreement
States equal to about $1.3 million, followed by an annual operating cost savings of
approximately $64,000.
Alternative 3 would amend NRC regulations as described in the Federal Register notice that has
been prepared for the final rule. These amendments would provide compatibility with IAEA and
DOT regulations and would make certain NRC-initiated regulatory changes to improve
regulatory efficiency as well as make small improvements to public health and safety. The
implementation cost would be approximately $1.9 million, followed by an annual savings to
industry of an estimated $134,000 (in 2014 dollars). The NRC has determined that Alternative 3
is superior to the other two alternatives, and improves regulatory efficiency.
15
6. IMPLEMENTATION
Compliance with the amendments adopted in the NRC’s final rule is required beginning July 13,
2015. However, the Agreement States have 3 years from the effective date of the final rule to
adopt compatible regulations.
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.
16
•
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.
•
L.D. Cunningham, "Columbium (Niobium) and Tantalum," Minerals Yearbook Volume 1.
Metals and Minerals, U.S. Bureau of Mines, 1992, pp. 435-436.
17
Appendix 1 Alternative 2 Licensee costs
Citation
Description
Number
Licensees
Annual
Responses
Cost per
Shipment/Hours
Per Response
71.14(a)
Natural material/ore could be
shipped without being classified as
hazardous material if it meets the
expanded exemption.
5
80
-500
Purchase copy of ISO standards.
250
Annual
hours
per
change
Total
Annual
Cost
One
Time
Cost
-$40,000
Total 10
Year 3%
NPV
Total 10
Year 7%
NPV
-$341,208
-$280,943
$50,000
Maintain awareness of changes to
the relevant transportation
regulations.
$7,500
240 licensees will need to read the
new regulations and will determine
actions necessary
240
240
2
480
71.75(d)
Will incorporate by reference the
alternate Class 4 impact test and
Class 6 temperature test and will
allow the Class 5 impact tests to be
used if the specimen weighs less
than 500 grams.
50
-50
1
-50
Appendix
A
$35,136
-$3,660
$2,500
-$31,221
-$25,706
Shipment cost savings detailed
below
-$20,000
$0
-$170,604
-$140,472
Total Alternative 2
-$63,660
$95,136
-$543,033
-$447,121
+one
time
cost
$95,136
$95,136
TOTAL
-$447,897
-$351,985
18
Shipment Cost Savings
Change
Truck
shipments/year
Discussion and Basis
for Estimates
Licensee cost or
savings to comply
with transportation
regulations
($/ truck shipment)
Annual Cost of
shipments
(2014$)
Table A-1
Cf-252
5
(500)
(2,500)
Kr-79
25
(500)
(12,500)
Kr-79
25
(100)
(2,500)
Te-121m
25
(100)
(2,500)
Table A-2
Totals
(20,000)
19
Appendix 2: Alternative 3 Costs
Licensee
Annual
hours
per
change
One
Time
Cost
Total 10
Year 3%
NPV
Total 10
Year 7%
NPV
$293
$0
$2,498
$2,057
-500
-$36,600
$0
-$312,205
-$257,063
25.00
-350
-$25,620
$0
-$218,544
-$179,944
125
1.00
125
$9,150
$0
$78,051
$64,266
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
Description
Number
Licensees
Annual
Responses
71.15(d)
*Revises the exemption that applies
to uranium enriched to a maximum
of 1 percent.
1
0.1
40
4
71.38(c)
Renewal of a CoC will be revised to
remove references to renewals of
QA program approvals, which will no
longer be necessary.
25
-25
20
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
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
71.135
Recordkeeping
250
Citation
Hours Per
Response
Total
Annual
Cost
$95,136
-$111,862
Total Alternative # 3
1
Note Alternative 3 includes all cost and benefits for “Alternative 2” in Appendix 1.
20
NRC Alternative # 3
Citation
Description
71.38
Issue new QA
program
approvals.
71.38( c)
Review
renewals of
QA program.
71.106 (a)
71.106(b)
Response
Per Year
Total
Annual
Responses
Labor
Hours Per
Response
240
0
0
0.17
$0
24
(1)
(24)
10
-$29,040
14
(1)
(14)
5
125
1
125
1
Number
Licensees
Total
Annual
Costs
Total 10 Yr 3
Percent NPV
Total 10 Yr
7 percent
NPV
$4,760
$4,760
$0
-$247,717
-$203,965
-$8,470
$0
-$72,251
-$59,490
$15,125
$0
$129,019
$106,232
$186,189
$152,463
One Time
Cost Per
$4,760
Holders of a
QA Program
Approval will
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 One
Time Cost
$4,760
-$22,385
21
TOTAL
| File Type | application/pdf |
| File Modified | 2014-10-10 |
| File Created | 2014-10-10 |