Regulatory Analysis for ICBMIP proposed rule

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10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material

Regulatory Analysis for ICBMIP proposed rule

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Regulatory Analysis for the
Exempt Distribution of Products Containing Byproduct
Material Incidental to Their Production
Proposed Rule
RIN No.: 3150-AJ54; NRC Docket ID: NRC-2015-0017

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

[Page Intentionally Blank]

ABSTRACT
Items containing byproduct material incidental to production are irradiated products that serve a
useful purpose and contain a minor amount of residual radiation incidental to the production
process. The residual byproduct material is not part of the intended end use of the products.
Current U.S. Nuclear Regulatory Commission regulations do not address these items, examples
of which include polycarbonate track etched membranes, irradiated gemstones, and certain
silicon materials used in the electronics industry.
The NRC is conducting this rulemaking to allow for the licensing of this class of irradiated
products under Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of general
applicability to domestic licensing of byproduct material,” and 10 CFR Part 32, “Specific
domestic licenses to manufacture or transfer certain items containing byproduct material.”
These changes address issues raised in petition for rulemaking PRM-30-65, “Petition for
Rulemaking Pursuant to 10 CFR § 2.802 On Behalf of GE Osmonics Inc.,” dated April 18, 2011
(Agencywide Documents Access and Management System Accession No. ML120250133), from
GE Osmonics, Inc. (the petitioner). Furthermore, the proposed rule is expected to have both
quantitative as well as qualitative benefits, i.e., (1) reduction in the regulatory burden on the
licensees by requiring only dose-criteria rather than both dose and concentration criteria;
(2) assurance that the NRC’s regulations continue to be consistent with new emerging
materials, avoiding product-specific rulemakings for future technologies; and (3) consistency
with the NRC’s current approach to licensing classes of exempt materials and products.
Table ES-1 below lists the areas analyzed by the NRC, including the staff-recommended action
and estimates of cost and potential benefits by issue. All costs are in 2021 dollars and are
calculated using a 7-percent discount rate.
Table ES-1 Recommended Action and Estimated Costs and Savings
Description

Net Benefit (Cost) by Affected Entity
(7% NPV) a,b,c
Industry

Agreeme
nt States

NRC

Total
(2021$)

Alternative 1 Status Quo - Do Nothing Different
Averted NRC Rulemaking Discontinuation Costs (SECY,
Letter, and FRN)

License Distributors and End Users

Alternative 1 Net Benefits (Costs)

($337,000)

($1,460,0
00)

($7,239,000)

($184,000)

($61,000)

($84,000)

$29,000

$40,000

$10,489,000

$12,213,000

$3,219,000

$11,648,000

($1,460,0
00)

Item C: Silica Chip Only
Item D: Gemstone Only regulated §32.11(c) exemption
Averted Alternative 1 Costs (SECY, Letter, and FRN)
Alternative 2 Net Benefits (Costs)

($1,797,
000)
($7,423,
000)
($145,00
0)
$69,000
$22,702,
000
$13,407,
000

a The total net benefit results are sensitive to the timing of when costs and benefits occur
and to the discount rate applied.
b

Benefits and averted costs are positive. Costs are (negative).

There may be differences between tables due to rounding.

The total cost in Table ES-1 includes estimates of the NRC implementation costs for 2 years,
and the operational costs, where applicable, during the first 15 years after the effective date of
the rule. The staff chose this time frame because this is the term of the license. The cost
estimates in Table ES-1 represent the net present value of costs (real expense) and averted
costs (potential savings). The proposed rulemaking (Alternative 2) recommended by the staff
would result in a total net overall savings of $13,407,000 using a 7-percent discount rate.
The proposed rulemaking cost estimate represents the following estimated costs and benefits
for the NRC, Industry, and the Agreement States:
•

The NRC is expected to result in a net savings of $11,648,000. This includes the
rulemaking development and implementation cost of ($337,000).

•

Agreement States are expected to incur a cost of ($1,460,000). This estimate
represents the implementation cost of the proposed rulemaking by the Agreement
States; the rulemaking action will not result in any operation costs to the Agreement
States. The Agreement States do not experience savings in licensing their distributors
and end users that the NRC benefits from because the exempt distribution regulations
are “Compatibility Category NRC,” which the Agreement States do not adopt.

•

The proposed rule would result in a net savings to the industry of $3,219,000. This net
savings represents operational savings resulting from applying the new rule and
implementation activities. Industry implementation costs include procedural and
administrative activities including reviewing and commenting on the proposed rule,
reading the final rule, and revising procedures and processes to comply.

Table of Contents
ABSTRACT .............................................................................................................................. i
List of Figures ......................................................................................................................... iv
List of Tables .......................................................................................................................... iv
Abbreviations and Acronyms ................................................................................................... v
Executive Summary ............................................................................................................... vi
1. Introduction ......................................................................................................................... 1
2. Statement of the Problem and Objective ............................................................................ 1
2.1 Background ............................................................................................................... 1
2.2 Need of the Proposed Action .................................................................................... 2
2.3 Objectives ................................................................................................................. 3
3. Identification and Preliminary Analysis of Alternatives ....................................................... 3
3.1 Alternative 1: Status Quo Take No Action................................................................. 3
3.2 Alternative 2: Rulemaking ......................................................................................... 4
3.3 Issue Guidance to Address Without Rulemaking ...................................................... 6
4. Estimation and Evaluation of Costs and Benefits ............................................................... 7
4.1 Basis for Cost and Savings Estimates ...................................................................... 7
4.2 Identification of Affected Attributes............................................................................ 7
4.3

Evaluation of Cost and Benefits for Alternative 2 ..................................................... 8

4.4 Analytical Methodology ............................................................................................. 9
4.4.1 Regulatory Baseline................................................................................................ 10
4.4.2 Affected Entities ..................................................................................................... 10
4.4.3 Base Year ............................................................................................................... 10
4.4.4 Discount Rates ....................................................................................................... 11
4.4.5 Cost/Benefit Inflators .............................................................................................. 11
4.4.6 Labor Rates ............................................................................................................ 12
4.4.7 Sign Conventions.................................................................................................... 13
4.4.8 Analysis Horizon ..................................................................................................... 13
4.4.9 Cost & Impact Considerations ................................................................................ 14
5. Other Considerations ....................................................................................................... 16
5.1 Guidance ................................................................................................................. 16
5.2 Exemption ............................................................................................................... 16
5.3 Stakeholder Interactions ......................................................................................... 16
5.4 Cumulative Effects of Regulation ............................................................................ 17
iii

5.5 Environmental Analysis ........................................................................................... 17
5.6 Support of Strategic Plan ........................................................................................ 18
5.7 Regulatory Flexibility Act ......................................................................................... 18
6. Summary of the Results ................................................................................................... 18
6.1 Summary of Quantified Net Benefits ....................................................................... 18
6.2

Staff-Recommended Rulemaking .......................................................................... 19

6.3

Benefits .................................................................................................................. 19

6.4 Non-quantified Benefits ........................................................................................... 20
6.5 Uncertainty Analysis................................................................................................ 20
6.5.1 Uncertainty Analysis Assumptions.......................................................................... 21
6.5.2 Uncertainty Analysis Results .................................................................................. 21
6.6 Summary of Uncertainty Analysis ........................................................................... 23
6.7 Decision Rationale .................................................................................................. 23
6.9 Implementation ....................................................................................................... 24
7. References ....................................................................................................................... 25
Appendix A: Assumptions and Assessment Supporting the Cost Analysis .......................... 27
List of Figures
Figure 1

Incremental Net Costs for Alternative 2 (7-Percent Discount Rate)

Figure 2

Alternative 2 Cost Drivers (7-Percent Discount Rate)

List of Tables
Table ES-1

Recommended Action and Estimated Costs and Savings ................................... vi

Table 1

CPI_U Inflator ...................................................................................................... 12

Table 2

Position Titles and Occupations .......................................................................... 13

Table 3

NRC Rulemaking Implementation Cost ............................................................... 14

Table 4

Total Net Costs by Affected Entity ....................................................................... 19

Table 5

Summary of Totals .............................................................................................. 24

Abbreviations and Acronyms
ADAMS
A/S

Agencywide Documents Access and Management System
Agreement State

CFR
CoC

Code of Federal Regulation
Certificate of Compliance

Executive Summary Table

FR
FRN

Federal Register
Federal Register Notice

General Electric

IAEA

International Atomic Energy Agency

μSv

microsieverts

NPV
NRC
NUREG

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

PCTE
PERT
PRM

Polycarbonate Track Etched Membranes
Program Evaluation and Review Technique
Petition for Rulemaking

Rem

Roentgen Equivalent Man

SDA
SRM

Standard Design Approval
Staff Requirements Memorandum

Executive Summary
Items containing byproduct material incidental to production are irradiated products that serve a useful
purpose and contain a minor amount of residual radiation incidental to the production process. The
residual byproduct material is not part of the intended end use of the products. Current U.S. Nuclear
Regulatory Commission regulations do not address these items, examples of which include
polycarbonate track etched membranes, irradiated gemstones, and certain silicon materials used in the
electronics industry.
The NRC is conducting this rulemaking to allow for the licensing of this class of irradiated products under
Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of General Applicability to
Domestic Licensing of Byproduct Material,” and 10 CFR Part 32, “Specific Domestic Licenses to
Manufacture or Transfer Certain Items Containing Byproduct Material.” These changes address issues
raised in petition for rulemaking PRM-30-65, “Petition for Rulemaking Pursuant to 10 CFR 2.802 On
Behalf of GE Osmonics Inc.,” dated April 18, 2011 (Agencywide Documents Access and Management
System Accession No. ML120250133), from GE Osmonics, Inc. (the petitioner).
Under the staff recommended alternative, the proposed rule would (1) establish standards for the exempt
distribution of products that contain byproduct material that is incidental to production, and (2) establish
ongoing requirements for the exempt distribution of products approved fordistribution under the new
provision.
The alternative considered is shown in Table ES-1: Executive Summary Table Recommended Action
and Estimated Costs and Savings. Table ES-1 below lists the items analyzed by the NRC, including the
staff-recommended alternative and estimates of cost and potential benefits by issue. All costs are in
2021 dollars and are calculated using a 7-percent discount rate. Alternative 2 results in an averted cost
of $13,407,000 at 7 percent.
Table ES-1

Recommended Action and Estimated Costs and Savings
Description

Net Benefit (Cost) by Affected Entity
(7% NPV)
Industry

Agreement
States

NRC

Total (2021$)

Alternative 1 Status Quo - Do Nothing Different
Averted NRC Rulemaking Discontinuation Costs (SECY,
Letter, and FRN)

License Distributors and End Users

Alternative 1 Net Benefits (Costs)

Alternative 2 Proceed with a Rulemaking Inclusive of Items Containing Byproduct Material Incidental to Production (staff’s
recommendation)
Item A: Rulemaking Implementation Costs Excluding
Rulemaking Termination Costs
Item B: PCTE Only
Item C: Silica Chip Only
Item D: Gemstone Only regulated §32.11(c) exemption
Averted Alternative 1 Costs (SECY, Letter, and FRN)
Alternative 2 Net Benefits (Costs)

($337,000)

($1,460,000)

($1,797,000)

($7,239,000)

($184,000)

($7,423,000)

($61,000)

($84,000)

($145,000)

$29,000

$40,000

$69,000

$10,489,000

$12,213,000

$22,702,000

$3,219,000

$11,648,000

($1,460,000)

$13,407,000

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

Benefits and averted costs are positive. Costs are (negative).

There may be differences between tables due to rounding.

The total cost in Table ES-1 includes estimates of the NRC implementation costs for 2 years, and the
operational costs, where applicable, during the first 15 years after the effective date of the rule. The staff
chose this time frame because, on average, the NRC rulemaking to has followed a 15-year cycle. This
requires applicants for subsequent license renewals to submit a renewal application no later than
15 years. The proposed rulemaking (Alternative 2) recommended by the staff would result in a net
overall savings of $13,407,000.
The proposed rulemaking cost estimate represents the following estimated costs for the Agreement
States (A/S), combined with an estimated net savings to the NRC and Industry:
•

The NRC is expected to result in a net savings of $11,648,000. This includes the rulemaking
development and implementation cost of ($337,000).

•

Agreement States are expected to incur a cost of ($1,460,000). This estimate represents the
implementation cost of the proposed rulemaking by the Agreement States; the rulemaking action
will not result in any operation costs to the Agreement States. The Agreement States do not
benefit from the averted costs that the NRC benefits from because the exempt distribution
regulations are “Compatibility Category NRC,” which the Agreement States do not adopt.

•

The proposed rule would result in a net savings to the industry of $3,219,000. This net savings
represents operational savings resulting from applying the new rule and implementation activities.
Industry implementation activities include procedural and administrative activities including
reviewing and commenting on the proposed rule, reading the final rule, and revising procedures
and processes to comply.

The proposed rulemaking is cost-justified in that net benefits that would be realized compared to the
status quo are estimated to exceed the rulemaking costs and industry implementation costs. The
proposed rule addresses nearly all the issues, and would result in net savings to the industry. It is
estimated that the proposed rule, if implemented, would result in a net savings of $3,219,000 in
averted costs to the licensees. This net savings value is based on 7% discounting over a 15-year
horizon. Furthermore, the proposed rule is expected to have both quantitative and qualitative
benefits, i.e., (1) reduction in regulatory burden on the licensees by requiring only dose-criteria rather
than both dose and concentration criteria; (2) assurance that the NRC’s regulations continue to be
consistent with new emerging materials, avoiding product-specific rulemakings for future
technologies; and (3) consistency with the NRC’s current approach to licensing classes of exempt
materials and products.

vii

Introduction

The U.S. Nuclear Regulatory Commission (NRC) is conducting this rulemaking to allow for
the licensing of this class of irradiated products under Title 10 of the Code of Federal
Regulations (10 CFR) Part 30, “Rules of general applicability to domestic licensing of
byproduct material,” and 10 CFR Part 32, “Specific domestic licenses to manufacture or
transfer certain items containing byproduct material.” These changes address issues raised
in petition for rulemaking PRM-30-65, “Petition for Rulemaking Pursuant to 10 CFR § 2.802
On Behalf of GE Osmonics Inc.,” dated April 18, 2011 (Agencywide Documents Access and
Management System Accession No. ML120250133), from GE Osmonics, Inc. (the petitioner).
This rulemaking would add a new class exemption from licensing and associated distribution
requirements. This new class exemption would create a path for licensing current and future
products that contain byproduct material incidental to production.

2.
2.1

Statement of the Problem and Objective
Background

PCTE membranes are used in a variety of research, medical, pharmaceutical, academic,
scientific, and industrial applications. The membranes are irradiated to create uniform pore
size and distribution, but themanufacturing process leaves behind small amounts of mixed
fission products in the membranes. Based on the NRC’s review of the product safety
analyses submitted by the petitioner (ADAMS Accession No. ML120800277), the incidental
radioactivity of these products presents de minimus risk to public health and safety.
The NRC docketed the petition in November 2011. On September 14, 2012, the NRC
published a notice in the Federal Register (FR) (77 FR 56793), stating that the petitioner
raised a valid regulatory issue about the commercial distribution of PCTE membranes and
that the NRC would consider the issue in the rulemaking process.
Under 10 CFR Part 30, the NRC regulates the manufacturing, production, transfer, receipt,
acquisition, ownership, possession, and use of byproduct material. NRC Agreement States
maintain compatible regulatory requirements regarding their jurisdiction. Typically, the NRC
and Agreement States regulate these processes through a specific or general license.
Additionally, the regulations in 10 CFR 30.11, “Specific exemptions,” through 10 CFR 30.22,
“Certain industrial devices,” provide exemptions from certain licensing requirements. One of
these exemptions appears in 10 CFR 30.14, “Exempt concentrations.”
Under 10 CFR 30.14, the NRC exempts any person from licensing requirements if the
productor material contains byproduct material in concentrations not in excess of those listed
in 10 CFR 30.70, “Schedule A—Exempt concentrations.” The regulations in 10 CFR 30.14 do
not permit the transfer of byproduct material contained in a product that is designed to be
ingested,inhaled, or applied to a human being. Additionally, 10 CFR Part 30 does not permit
the introduction of byproduct material into a product, even in exempt concentrations, unless
the person introducing the byproduct material has a specific license issued under 10 CFR
32.11, “Introduction of byproduct material in exempt concentrations into products or
materials, and transfer of ownership or possession: Requirements for license.”

The regulations in 10 CFR 32.11 provide the requirements for obtaining a specific license
authorizing the introduction of byproduct material into a product or material that will eventually
be transferred to a person exempt, in accordance with 10 CFR Part 30, from the licensing
requirements.
These current regulations do not cover items that contain byproduct material incidental to
production; therefore, these items cannot be licensed for exempt transfers. This class of
products includes irradiated gemstones; however, in the staff requirements memorandum
(SRM) for SECY-87-186A (ADAMS Accession No. ML092400170), the NRC allowed the
interim licensingof irradiated gemstones pursuant to exemptions applied to 10 CFR 32.11 and
10 CFR 30.14. The NRC determined that this practice would not be appropriate for regulating
all irradiated items of this type, for the reasons outlined below in Section 3.

2.2

Need of the Proposed Action

The current regulations in 10 CFR Part 30 and 10 CFR Part 32 do not support the exempt
distribution for the class of products containing byproduct material incidental to production.
Specifically, both 10 CFR 30.14 and 10 CFR 32.11 provide that the concentrations of
byproduct material in a product do not exceed the values listed in Schedule A in 10 CFR
30.70. However, Schedule A would not be appropriate for this class of products for the
following reasons.
First, the concentrations in Schedule A pertain to volumetric concentrations in an item
containing byproduct material. While volumetric concentrations are useful and
appropriate for some products, the NRC is aware of certain products
(e.g., polycarbonate membranes, which are thin films) for which volumetric
concentrations would not be appropriate due to the products’shape. Consequently, the
basis for volumetric concentrations in Schedule A would not be applicable to several
items that are in this class of products.
Second, the maximum concentration limits of Schedule A are based on the potential
internal dose from the product from continuous occupational exposure. Potential
exposures from the irradiated products under consideration involve mainly external
exposures, and concentration values, based on continuous internal occupational
exposure, are not representative in these situations. Therefore, the Schedule A
concentration limits would not beappropriate for this class of products.
Third, the list of radionuclides in Schedule A is not comprehensive for all potential
radionuclides in this class of products. While some of the potential radionuclides in
these products would fall within the catch-all provision of Schedule A (i.e., beta- or
gamma-emitting byproduct material with a half-life less than 3 years), Schedule A will
not capture other radionuclides that are in this class of products. For example, PCTE
membranes are exposed to nuclear fission fragments, including strontium-90, which
remain embedded in the membranes. Schedule A has never specifically included
strontium-90 in the table, and strontium-90 would not fall under the catch-all provision
of Schedule A because its half-life is more than 27 years. As a result, Schedule A
would not include several items that would be in this class of products, such as PCTE
membranes, because it does not capture, either specifically or in the catch-all provision,
all radionuclides that may be in these products.
2

Fourth, under the exemption provided by 10 CFR Part 30 and the requirements for a
license under 10 CFR 32.11, these irradiated products must not be designed to be
ingested, inhaled, or applied, to a human being. However, some items in this class of
products could be ingested, inhaled, or applied to a human being. As a result, this
prohibition makes the current regulatory structure inappropriate for this class of
products.
For the reasons noted above the existing regulatory structure does not support the licensing
and distribution of this class of products, under the exempt products category. Nevertheless,
these irradiated products are widely used in a variety of beneficial applications, and a
regulatory structure provides certainty in a pathway to licensing for this class of products. As
a result, revising the regulations is appropriate to allow the potential use of these products
under the exemption and distribution provisions in 10 CFR Part 30 and 10 CFR Part 32.

2.3

Objectives

The NRC is conducting this rulemaking to allow for the licensing of this class of irradiated
products under Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of
general applicability to domestic licensing of byproduct material,” and 10 CFR Part 32,
“Specific domestic licenses to manufacture or transfer certain items containing byproduct
material.” The current regulations in 10 CFR Parts 30 and 32 do not support the exempt
distribution for the class of products containing byproduct material incidental to production.
Specifically, the provisions of both §§ 30.14 and 32.11 provide that the concentrations of
byproduct material in a product not be in excess of the values listed in Schedule A in § 30.70.
However, Schedule A is not inclusive of all isotopes in this class of irradiated products.

Identification and Preliminary Analysis of Alternatives

The NRC analyzed the Status Quo and Rulemaking alternatives to the proposed rule as
described in this section.

3.1

Alternative 1: Status Quo Take No Action

The NRC’s Consumer Product Policy Statement, published in the Federal Register
on January 16, 2014 (79 FR 2907), states that the NRC should evaluate the overall
safety impact of products allowed to be distributed for use by the general public.
Products are normally used under an exemption from licensing and from all
associated regulatory requirements. The policy statement notes that the general
criterion for approval of products containing radioactive material depends on the
resulting radiation exposures to the public and the apparent usefulness of the
product. Under this alternative, the NRC would continue to rely on existing
regulations, orders, and guidance, and no resources would be necessary to perform
rulemaking activities. These products are widely used, and this alternative would
require each manufacturer, distributor, and user of an irradiated item in this class,
except gemstones (see Section 2), to possess a specific license. The resources
associated with this approach are outlined in Appendix A. Preparing and evaluating
each specific license request would also require NRC resources, as outlined in
Appendix A. Without this rulemaking, potential applicants would need to apply for a

specific license to distribute these products, and the end user would need to obtain a
possession license to use the products, resulting in additional cost. These costs
make the distribution of items such as PCTE membranes and future irradiated
products financially challenging, using the current regulatory structure. Further,
recognizing the National Materials Program, each Agreement State would need to
issue a specific license for these materials, which may cause transboundary issues.
Gemstone licensees would continue to be licensed under the current framework and
would continue to provide concentration and dose-based criteria in their applications.
Additionally, this alternative would require the NRC to prepare a Commission paper, a
letter to the petitioner, and a Federal Register notice (FRN) to deny the petition and
close out PRM-30-65.
For these reasons, continuing with Alternative 1 results in costs to the Licensee
Distributors and End Users, as well as the NRC. The costs incurred as described in
the preceding two paragraphs are shown as averted costs or benefits in Alternative 2
if Alternative 2 is selected. This is done to show Alternative 1 as the no-cost
baseline.

3.2

Alternative 2: Rulemaking

The rulemaking will amend 10 CFR Part 30 and 10 CFR Part 32 to (1) add to 10 CFR
Part 30 a new class exemption from licensing requirements and (2) add associated
distribution requirements to 10 CFR Part 32. These changes would apply dose criteria,
rather than concentration, as the primary means of protecting health and safety. These
proposed changes would fully address PRM‑30‑65, provide a regulatory framework for
current (e.g., gemstones) and future irradiated products, and allow this class of products
to be licensed without product-specific exemptions that require additional rulemaking in
the future. This new regulatory structure would require a licensee to meet only dosebased criteria, which would reduce the burden on current gemstone licensees, who are
currently required to provide both concentration and dose-based criteria, as well as limit
the NRC’s review to only dose-based criteria in the license applications.
In addition to providing dose measurements, the current distributors of irradiated
gemstones use a variety of measurements and statistical analysis methods to
demonstrate that the concentration of byproduct material at the time of sale to
consumers is unlikely to exceed the concentration limits in 10 CFR Part 30 (and derived
concentrations for those not specifically included). Under the new provisions, current
licensees and applicants (initial distributor or transferrer) would demonstrate that their
products are unlikely to result in doses exceeding the dose criteria in the new
provisions.
The NRC will amend 10 CFR Part 30 to add a new section specific to products
containing byproduct material that is not part of the intended end use of the product but
instead is present as a result of production. This new section would only apply to
processes that unavoidably result in the incidental addition of byproduct material to the
final product. The NRC would add companion paragraphs to 10 CFR 32.11 with the
applicable licensing requirements for distribution. The new section in 10 CFR Part 30
would only apply to those products or materials that have an exempt distribution license
under 10 CFR 32.11. In the past, the NRC has established class exemptions for
categories of products or devices with similar characteristics, rather than establishing
individual exemptions for each product. These exemptions appear in 10 CFR Part 30,
4

“Self-luminous products containing tritium, krypton-85, or promethium-147”;
10 CFR 30.20, “Gas and aerosol detectors containing byproduct material”; and
10 CFR 30.22, “Certain industrial devices.” The planned rulemaking approach is similar
to that for 10 CFR 30.19, 10 CFR 30.20, and 10 CFR 30.22 in that the regulatory
structure would allow new products to be licensed without product-specific exemptions,
each of which would otherwise require additional rulemaking. Public health and safety
are ensured by evaluating each specific product against safety criteria contained in the
regulations that apply to all products in a class.
The new provision would be similar in some respects to the class exemptions in the
current regulations in that it would require applicants requesting authorization to
distribute a product or material to demonstrate that the product or material would meet
certain safety criteria. The NRC specifies these safety criteria in 10 CFR 32.23,
“Same [specific domestic licenses to manufacture or transfer certain items containing
byproduct material]: Safety criteria”; 10 CFR 32.27, “Same [specific domestic licenses
to manufacture or transfer certain items containing byproduct material]: Safety
criteria”; and 10 CFR 32.31, “Certain industrial devices containing byproduct material:
Safety criteria.” These safety criteria would form the primary means of ensuring
adequate protection of public health and safety. Applicants requesting authorization to
manufacture, possess, or distribute items containing byproduct material incidental to
production would be required to demonstrate compliance with the safety criteria.
These criteria would cover normal use, handling, storage, marketing, distribution,
installation, servicing, and disposal as well as potential accidents and misuse.
Under this alternative, the NRC would issue a proposed rule in the Federal Register that
would:
(1)

(2)

Establish standards for the exempt distribution of products that contain
byproduct material that is incidental to production. These standards would
include requiring applicants to provide information relating to the design,
manufacture, prototype testing (if applicable), quality control procedures,
labeling and marking, and conditions of handling,storage, use, and disposal of
the products to demonstrate that the product would meet the following specific
safety criteria:
(a)

dose limits to the general public and those occupationally
exposed1 to theproduct, including through transportation,
distribution, use, and disposal

(b)

prototype testing (if applicable) to demonstrate the degree of binding or
containment under the most severe conditions likely to be encountered
in normaluse of the product

Establish ongoing requirements for the exempt distribution of products
approved fordistribution under the new provision:
(a)
(b)
(c)

labeling requirements for final product packaging
quality control/quality assurance
recordkeeping and annual transfer reporting

Individuals occupationally exposed include users of PCTE membranes, truck drivers,
warehouse workers, and waste disposal workers. For the class exemptions, the
existing criteria for such groups are 5–20 millirem (mrem)/year (50–200 microsieverts
(μSv)/year) except for disposal scenarios, for which the criterion is 1 mrem/year
(10 μSv/year), because the same individuals could be impacted by all of the products
allowed to be disposed in landfills and municipal incinerators.
This generic provision would present a more appropriate regulatory framework for
irradiated products of this class. It would allow for new products and materials to be
developed, evaluated, and licensed under a framework that would adequately protect
health and safety without the need for additional rulemaking. The safety criteria would
be robust enough to cover any potential future irradiated products. In the long term,
these comprehensive proposed changes would be the most cost-effective solution to
the NRC and the industry because other irradiated products are expected to be
brought to market in the future.
The NRC is issuing draft guidance in conjunction with this proposed rule. Current
guidance on 10 CFR parts 30 and 32 for exempt distribution licenses is provided in
NUREG-1556, Volume 8, Revision 1, “Consolidated Guidance About Materials
Licenses: Program-Specific Guidance About Exempt Distribution Licenses.” The
draft guidance is intended for use by applicants, licensees, Agreement States, and
the NRC staff when preparing and evaluating an exempt distribution licensing action
for items containing byproduct material incidental to production. These exempt
distribution licenses will authorize the initial distribution of byproduct material
incidental to production to persons exempt from the regulatory requirements (exempt
distribution) for an NRC license under 10 CFR part 30 and exempt from licensing
requirements under the equivalent provisions in Agreement State regulations.

3.3

Issue Guidance to Address Without Rulemaking

Regulatory guides and NUREGs provide guidance to licensees and applicants for
carrying out specific parts of the NRC’s regulations, for techniques used by the NRC
staff in evaluating specific problems or postulated accidents, and for data needed by
the NRC staff in its review of applications for permits or licenses.
Under this alternative, the NRC would revise, during its regular revision schedule,
NUREG-1556, “Consolidated Guidance about Materials Licenses,” Volume 8,
Revision 1, “Program-Specific Guidance About Exempt Distribution Licenses,” issued
June 2018 (ADAMS Accession No. ML18158A165), which contains guidance for the
issuance of licenses authorizing distribution to exempt persons. The NRC would
revise NUREG-1556 to include licensing guidance specific to items containing
byproduct material incidental to production.
However, guidance cannot impose new requirements on licensees and, therefore,
guidance alone is not a viable approach to provide for the use of a product under
exemption from licensing. Therefore, reliance on guidance alone to resolve this
regulatory issue is not possible.

Estimation and Evaluation of Costs and Benefits

This section describes the process for evaluating the costs and benefits expected to
result from Alternative 2 relative to the regulatory baseline (Alternative 1).

4.1

Basis for Cost and Savings Estimates

The following is a summary of the implementation and operational costs to industry
(licensees), the NRC, and the Agreement States. Each attribute describes how
Alternatives 1 and 2 impacts each attribute. Included in the description are what
additional activities would be required and what specific costs would be avoided.

4.2

Identification of Affected Attributes

This section identifies the components of the public and private sectors, commonly referred to as
“attributes,” that are expected to be affected by the Alternative 1 Status Quo or Alternative 2
Rulemaking. The inventory of the attributes listed in NUREG/BR-0058 Revision 5 were used
to determine impacts. The alternatives would apply to licensees and applicants for licensing of
this class of irradiated products under Title 10 of the Code of Federal Regulations (10 CFR)
Part 30, “Rules of general applicability to domestic licensing of byproduct material,” and
10 CFR Part 32.

Industry Implementation. This attribute accounts for the projected net economic
effect on the affected licensees to implement the mandated changes. Costs include
procedural and administrative activities related to establishing plans and revising
procedures. Normal costs (actual expenses) are considered negative, and cost
savings and averted costs are considered positive. There are no Industry
implementation costs.
Industry Operation. This attribute accounts for the projected net economic effect
caused by routine and recurring activities required by the proposed guidance or
regulation changes. Activities currently performed but which would no longer be
required if the alternative is implemented are treated as averted costs. For
Alternative 2, Industry would incur a cost for PCTE and Silica Chip licensing
activities of ($7,239,000) and ($61,000) respectively. Gemstones have an averted
cost of $29,000.
NRC Implementation. This attribute accounts for the projected net economic effect
on the NRC if the rule is implemented. It includes NRC implementation costs for
rulemaking including developing regulatory guides, developing the proposed rule,
comment resolution for the final rule, and potential savings relative to those expected
under the regulatory baseline as described in section 4.4.1. This is estimated to
result in a cost of ($337,000).
NRC Operation. This attribute accounts for the projected net economic effect on the
NRC after the rule is developed and implemented. For Alternative 2, the NRC would
incur a cost for reviewing PCTE and Silica Chip licensing activities of ($184,000) and
($84,000) respectively. Gemstones have an averted cost of $40,000.

Agreement States Implementation. This attribute accounts for the projected net
economic effect on the Agreement States to implement all the mandated changes in
Parts 30 and 32. Costs include procedural and administrative activities related to
harmonizing State regulations with NRC policy and other guidance documents.
NMSS procedure SA-200 describes the categories related to harmonizing State regulations
with NRC policy. The Agreement States must have compatible regulations for those
regulations that are Compatibility Categories A, B, C, and Health and Safety. Regulations
that are a D compatibility category are not required for compatibility purposes, but Agreement
States can adopt those as well if they want. Compatibility Category NRC regulations are
those which the Agreement States cannot adopt because these are strictly for NRC use.
The NRC regulations or equivalent legally binding requirements should be adopted
and implemented within a 3-year timeframe from the effective date of the NRC's final
rule as stated in the Federal Register notice. The Agreement States implementation
costs were estimated based on the following considerations:
•

The number of Agreement States is 39 based on NRC data located at
“https://scp.nrc.gov/rulemaking.html”. However, the number of affected
Agreement States is 38. The State of Wyoming is not included in this count at
this time because Wyoming has a limited Agreement that does not include
materials subject to the regulations in this rulemaking.

•

The average hourly rate range for a State employee is $95/hour ($32 to $161
range).

•

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

The NRC determined that there are implementation costs incurred by the
Agreement States because of the proposed rule. Agreement States are expected to
incur a cost of ($1,460,000). The Agreement States do not benefit from the averted
costs that the NRC benefits from because the exempt distribution regulations are
“Compatibility Category NRC,” which the Agreement States do not adopt.
Agreement States Operation. The rulemaking action will not result in any operation
costs to the Agreement States.

4.3

Evaluation of Cost and Benefits for Alternative 2

This section discusses the cost and potential impacts of the proposed changes
presented in Section 4 on licensees, the NRC, and Agreement States. The analyses
presented in this section are based on the NRC’s initial assessment. The NRC
considered two alternatives: the status quo (Alternative 1) and rulemaking
(Alternative 2). Appendix A provides the assumptions and assessment supporting the
cost analysis.

4.4

Analytical Methodology

This section describes the process used to evaluate costs and benefits associated with
Alternative 2. The benefits of Alternative 2 include any desirable changes in affected
attributes (e.g., monetary savings, improved safety, and improved security). The costs
include any undesirable changes in affected attributes (e.g., monetary costs, increased
exposures). All costs and benefits are monetized, when possible. The total costs and
benefits are then summed to determine whether the difference between the costs and
benefits results in a positive benefit. In some cases, costs and benefits are not
monetized because meaningful quantification is not possible.
Of the 10 affected attributes, the analysis evaluates four on a quantitative basis,
“industry implementation, industry operation, NRC implementation, and NRC
operation.” Quantitative analysis requires a baseline characterization of the affected
society, including factors such as the number of affected entities, the nature of the
activities currently performed, and the types of systems and procedures that licensees
or applicants would implement, or would no longer implement, because of the
alternatives. Where possible, the staff calculated costs for these five attributes using
three-point estimates to quantify the uncertainty in these estimates. The detailed cost
tables used in this regulatory analysis are included in the individual sections for each of
the provisions.
The NRC evaluated the remaining attributes on a qualitative basis because some
benefits relating to consistent policy application and improvements in ISI and IST
techniques are not quantifiable or because the data necessary to quantify and monetize
the impacts on these attributes are not available.
•

Improvements in Knowledge: This attribute accounts for improvements in
knowledge acquired as the industry and the staff gain experience with new
technology before its incorporation into Part 30 and Part 32 and by permitting
licensees to avoid costs in asking for incorporating new technologies.

•

Regulatory Efficiency: This attribute accounts for regulatory and compliance
improvements resulting from the implementation of Alternative 2 relative to the
regulatory baseline. Alternative 2 would continue the best practice of aligning
NRC regulations with ICBMIP licensing standards, reducing the effort the
industry expends generating these requests and considering alternative means
to accomplish the goals of these provisions.

•

Other Considerations: This attribute accounts for considerations not captured in
the preceding attributes. Specifically, this attribute accounts for how Alternative
2 meets specific requirements of the Commission, helps achieve NRC policy,
and provides other advantages.

•

Attributes with No Effects: Attributes not expected to be affected under any of
the alternatives include considerations of public health (routine), offsite property,
onsite property, the public, and safeguards and security.

The staff documents its assumptions throughout this regulatory analysis. For reader
convenience, Appendix A summarizes the major assumptions and input data.

4.4.1

Regulatory Baseline

This regulatory analysis identifies the incremental impacts of Alternative 2 relative to a
baseline (Alternative 1, the Status Quo alternative). The final rule is compared to a baseline
that reflects anticipated behavior if the NRC does not undertake regulatory or nonregulatory
action (Alternative 1, the Status Quo alternative). The regulatory baseline assumes full
compliance with existing NRC requirements, including current regulations and relevant
orders. This is consistent with NUREG/BR-0058, Revision 5 “U.S. Nuclear Regulatory
Commission Guidance on Performing Cost-Benefit Analyses”, ADAMS Accession
No. ML17221A000 which states that in evaluating a new requirement, the staff should
assume that all existing NRC and Agreement States requirements have been implemented.”
Section 6 of this regulatory analysis presents the estimated incremental costs and benefits of
the alternatives compared to this baseline.

4.4.2

Affected Entities

The proposed changes would provide a regulatory framework for the distribution of irradiated
products (e.g., gemstones and PCTE membranes) for current and future NRC licensees.
The proposed rule would affect approximately 27 licensees that are subject to the rulemaking
and manufacture and/or distribute items containing byproduct material incidental to
production, some of which may qualify as small business entities as defined by 10 CFR
2.810. Based upon historical data, the staff estimates that approximately 2 out of the 27
estimated licensees subject to this rulemaking, may qualify as small business entities as
defined by 10 CFR 2.810. These 2 small business entities are anticipated to be gemstone
licensees. It is expected that all businesses will incur the same savings resulting from the
licensing process. These savings are a small percentage of the gross sales; therefore, we
conclude that there will be no significant economic impact to small business entities. On the
basis of the draft regulatory analysis conducted for this action the estimated averted cost of
the proposed rule for affected licensees is $40,000 at 7 percent. The NRC believes that the
selected alternative reflected in the proposed rule is the least burdensome, most flexible
alternative that would accomplish the NRC's regulatory objective.
Licensees currently distributing irradiated gemstones under 10 CFR 32.11, for use under
10 CFR Part 30, can amend their licenses to comply with the new provisions at the time of
the next license renewal. These new provisions will be substantially less burdensome
because the licensee would not need exemptions under the new provision and would not be
required to submit the concentration data for review.

4.4.3

Base Year

All monetized costs are expressed in 2021 dollars. Ongoing costs of operation related to the
alternative being analyzed are assumed to begin no earlier than 30 days after publication of
the final rule in the Federal Register unless otherwise stated, and they are modeled on an
annual cost basis. The NRC assumes that the rule will be effective in 2024.
One-time NRC implementation costs related to rulemaking are considered sunk costs at the
final rule stage.
Recurring annual operating expenses are estimated. The values for annual operating
expenses are modeled as a constant expense for each year of the analysis horizon where
10

appropriate. The NRC performed a discounted cash flow calculation to discount these
annual expenses to 2021 dollar values.

4.4.4

Discount Rates

In accordance with guidance from U.S. Office of Management and Budget (OMB)
Circular A-4, “Regulatory Analysis,” issued October 2003 (OMB, 2003), and
NUREG/BR-0058, draft Revision 5, net present value (NPV) calculations are used to
determine 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 NPVs, costs and benefits,
regardless of when the cost or benefit is incurred, are valued to a reference year for
comparison. The choice of a discount rate and its associated conceptual basis is a topic of
ongoing discussion within the Federal Government. Based on OMB Circular A-4 and
consistent with NRC past practice and guidance, present-worth calculations in this analysis
use 3-percent and 7-percent real discount rates. A 3-percent discount 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 to reflect reliance on the discounting concept of social rate of time
preference.1 A 7-percent discount rate approximates the marginal pretax real rate of return
on an average investment in the private sector, and it 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. A 7-percent rate is consistent with an opportunity cost2 of capital concept to reflect
the time value of resources directed to meet regulatory requirements.

4.4.5

Cost/Benefit Inflators

The NRC estimated the analysis inputs for some attributes based on the values published in
the sources referenced, which are provided in prior year dollars. To evaluate the costs and
benefits consistently, these inputs are put into base year dollars. The most common inflator
is the Consumer Price Index for All Urban Consumers (CPI-U), developed by the
U.S. Department of Labor, Bureau of Labor Statistics (BLS). Using the CPI-U, the prior year
dollars are converted to 2021 dollars. The following formula is used to determine the amount
in 2021 dollars:
−
=
−
Table 1 summarizes the values of CPI-U used in this regulatory analysis.

The “social rate of time preference” discounting concept refers to the rate at which society is willing to
postpone a marginal unit of current consumption in exchange for more future consumption.

“Opportunity cost” represents what is foregone by undertaking a given action. If the licensee personnel were
not engaged in revising procedures, they would be occupied by other work activities. Throughout the
analysis, the NRC estimates the opportunity cost of performing these incremental tasks as the industry
personnel’s pay for the designated unit of time.

Table 1

CPI-U Inflator
Base Year

CPI-U Annual
Average

Percent Change from
Previous Year

2021
2022
2023
2024

264.71 a
271.06 a
277.84 b
284.74 b

2.40%
2.50%
2.45%

Sources:
a
BLS, “Databases, Tables & Calculators by Subject: CPI Inflation Calculator,” issued May 2020 (BLS, 2020).
b
Congressional Budget Office, “The Budget and Economic Outlook: 2019 to 2029,” issued January 2020 (Congressional
Budget Office, 2020).

4.4.6

Labor Rates

For the purposes of this regulatory analysis, the NRC developed labor rates that include only
labor and material costs that are directly related to the implementation, operation, and
maintenance of the final rule requirements. This approach is consistent with the guidance in
NUREG-BR-0058, Revision 5, “Regulatory Analysis Guidelines of the U.S. Nuclear
Regulatory Commission,” April 2017, (ADAMS Accession No. ML17100A480) and general
cost-benefit methodology. The NRC incremental labor rate is $137 per hour in 2021 dollars.3
The NRC used the 2020 BLS Occupational Employment and Wages data
(http://www.bls.gov) for the Pharmaceutical Preparation Manufacturing: [Manufacturing
Sector: 31-33]–Nuclear Medicine (Radioactive Isotopes) Preparations Manufacturing (NAICS)
Code 325412 which provide and the mean hourly wage rate for this NAICS code, and used
the inflator discussed above to inflate these labor rate data to 2021 dollars. The labor rates
used in the analysis reflect total hourly compensation, which includes wages and nonwage
benefits (using a burden factor of 2.4, applicable for contract labor and conservative for
Pharmaceutical Preparation Manufacturing). The NRC used the BLS data tables to select
hourly labor rates for performing the estimated procedural, licensing, and Nuclear Medicine
(Radioactive Isotopes) Preparations Manufacturing necessary during and following
implementation of the alternative. In establishing this labor rate, wages paid to the individuals
performing the work plus the associated fringe benefit component of labor cost (i.e., the time
for management over and above those directly expensed) are considered incremental
expenses and are included. Table 2Error! Reference source not found. summarizes the
BLS labor categories that were used to estimate industry labor costs to implement this
proposed rule, and Appendix A lists the industry labor rates used in the analysis. The NRC
also performed an uncertainty analysis, which is discussed in this Regulatory Analysis.

The NRC labor rates presented here differ from those developed under the NRC’s license fee recovery
program (10 CFR Part 170, “Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory
Services under the Atomic Energy Act of 1954, as Amended”). NRC labor rates for fee recovery purposes
are appropriately designed for full-cost recovery of the services rendered and thus include nonincremental
costs (e.g., overhead, administrative, and logistical support costs).

Table 2

Position Title

Technical
Staff

Administrative
Staff

Position Titles and Occupations

Occupation (SOC code)

Pharmaceutical
Preparation
Manufacturing: [Manufact
uring Sector: 31-33] Nuclear Medicine
(Radioactive Isotopes)
Preparations
Manufacturing (325412)
Office and Administrative
Support Occupations
(430000)
First-Line Supervisors of
Office and Administrative
Support Workers
(431011)
Office Clerks General
(439061)

Year

Hourly
mean
wage

Hourly
25th
percentile
wage

Hourly
75th
percentile
wage

Source

2021

$35.46

$25.89

$52.13

https://www.bls.gov/iag/tgs/iag325.
htm#iag325cesehallemp.f.p

2020

$20.38

$14.69

$24.40

https://www.bls.gov/oes/current/oe
s430000.htm

2020

$29.81

$21.59

$35.90

https://www.bls.gov/oes/current/oe
s431011.htm

2020

$18.16

$13.26

$21.87

http://www.bls.gov/oes/current/oes
439061.htm

$22.78

$16.51

$27.39

Average

Licensing
Staff

Paralegals and Legal
Assistants (232011)

2020

$27.22

$19.54

$32.25

https://www.bls.gov/oes/current/oe
s232011.htm

Lawyers (231011)

2020

$71.59

$40.60

$91.11

https://www.bls.gov/oes/current/oe
s231011.htm

$49.41

$30.07

$61.68

Average

(1) SOC code: Standard Occupational Classification code -- see http://www.bls.gov/soc/home.htm
(2) NAICS code: North American Industry Classification System code -- see http://www.bls.gov/bls/naics.htm

4.4.7

Sign Conventions

The sign conventions used in this analysis are that all favorable consequences for
the alternative are positive i.e., averted costs; and all adverse consequences for the
alternative are negative. Negative values are shown using parentheses (e.g.,
negative $500 is displayed as ($500)). Averted costs are costs of activities and
actions performed under the existing regulations that would no longer be required if
a revision to the regulations is implemented, and they are assigned positive values.
Normal costs are implementation and operational costs of new or additional actions
associated with the proposed rule, if approved, and they are assigned negative
values.

4.4.8

Analysis Horizon

The average expiration date of the operating licenses is 2038, which results in approximately
15 years of operation. The proposed changes would provide a regulatory framework for the
distribution of irradiated products (e.g., gemstones and PCTE membranes) for current and
future NRC licensees. Licensees currently distributing these products under § 32.11, for use
under § 30.14, can amend their license to comply with the new provisions at the time of the
next license renewal.

4.4.9

Cost & Impact Considerations

Industry Implementation
This attribute accounts for the projected net economic effect on the affected licensees
to implement the mandated changes. Costs include procedural and administrative
activities related to establishing plans and revising procedures. Additional costs above
the regulatory baseline, as discussed in Section 4.4.1, are considered negative, and
cost savings and averted costs are considered positive. There were no Industry
implementation costs.
Industry Operations
This attribute accounts for the projected net economic effect of routine and recurring activities
required by the alternative for all affected licensees.
There are 9 estimated PCTE Manufacturers and/or Distributors (# Licensees Submittals) who
would provide submittals. Each PCTE Licensee submittal requires 60 hours of preparation
time at a labor rate of $100. These costs are estimated to occur in 2024, which is the
estimated effective date of the rule, and 15-years later in 2038 during license renewal
resulting in a cost of ($61,000) at 7-percent. (See Table A-9.)
There are 2,000 estimated PCTE End User Entities (not Manufacturers and/or
Distributors) who would provide submittals. Each PCTE End User Entities Licensee
submittal requires 50 hours of preparation time at a labor rate of $100. These costs are
estimated to occur in a 5-year timeframe beginning in 2024 through 2028 resulting in a
cost of ($7,177,000) at 7-percent. See Table A-11.
There are 9 estimated Silica Chip Entity Initial License Applicants who would provide
submittals. Each Silica Chip Entity Initial License Applicant submittal requires 60 hours of
preparation time at a labor rate of $100. These costs are estimated to occur in 2024 and 15years later in 2038 during license renewal resulting in a cost of ($61,000) at 7-percent. (See
Table A-13.)
There are 9 estimated Gemstone Entity Licensees who would provide submittals. Each
Gemstone Entity Licensee submittal will save 40 hours of preparation time at a labor
rate of $100. These averted costs are estimated to occur in 2024 resulting in an
averted cost of $29,000 at 7-percent. (See Table A-15.)
NRC Implementation
Table 3
Year

NRC Rulemaking Implementation Cost
Activity

Hours

NRC
hourly
rate

Total Cost

Undiscounted
2022

Develop/issue RG for final rule

388

$137

($53,197)

7% NPV
($49,716)

3% NPV
($51,647)

2022

Develop/issue final rule

971

$137

($132,991)

($124,291)

($129,118)

2023

Develop/issue Comment Resolution for
final rule

388

$137

($53,197)

($46,464)

($50,143)

2023

Complete final rule

971

$137

($132,991)

($116,160)

($125,357)

($372,376)

($336,631)

($356,265)

Net (Cost) Benefit:

2,718

NRC Operations
There are 9 estimated NRC reviews of PCTE Licensing Entities. Each NRC review of PCTE
Entity Licensee applicant submittal requires 60 hours at a labor rate of $137. These costs
are estimated to occur in 2024 and 15-years later in 2038 during license renewal resulting in
a cost of ($84,000) at 7-percent. (See Table A-10.)
The NRC is estimated to review 9 PCTE End User Entities who would provide submittals.
Each NRC review of PCTE End User Entities Licensee submittal requires 100 hours at a
labor rate of $137. This results in a cost of ($101,000) at 7-percent. (See Table A-12.)
The NRC is estimated to review 9 Silica Chip Entity Initial License Applicants who
would provide submittals. Each NRC review of Silica Chip Entity Initial License
Applicant submittal requires 60 hours at a labor rate of $137. These costs are
estimated to occur in 2024 and 15-years later in 2038 during license renewal resulting
in a cost of ($84,000) at 7-percent. (See Table A-14.)
The NRC is estimated to avert the review of 9 Gemstone Entity Licensees who would provide
submittals. Each NRC review of Gemstone Entity Licensee applicant submittal requires 40
hours at a labor rate of $137. These averted costs are estimated to occur in 2024 resulting in
an averted cost of $40,000 at 7-percent. (See Table A-16.)
Agreement States Implementation
This attribute accounts for the projected net economic effect on the Agreement States
to implement all the mandated changes in Parts 30 and 32. Costs include procedural
and administrative activities related to harmonizing State regulations with NRC policy
and other guidance documents. Agreement States are expected to incur a cost of
($1,460,000). This estimate represents the implementation cost of the proposed
rulemaking by the Agreement States. The Agreement States do not benefit from the
averted costs that the NRC benefits from because the exempt distribution regulations
are “Compatibility Category NRC,” which the Agreement States do not adopt. (See
Table A-7.)
Agreement States Operation
The rulemaking action will not result in any operation costs to the Agreement States.

Other Considerations

This section discusses the alternatives to rulemaking that the staff considered, as well
as why the alternatives would not be effective approaches to resolve the regulatory
problem identified above in Section 3.

5.1

Guidance

Regulatory guides and NUREGs provide guidance to licensees and applicants for
carrying out specific parts of the NRC's regulations, for techniques used by the NRC
staff in evaluating specific problems or postulated accidents, and for data needed by
the NRC staff in its review of applications for permits or licenses. However, guidance
cannot impose new requirements on licensees and, therefore, is not viable to provide
for the use of a product under exemption from licensing. Therefore, reliance on
guidance alone to resolve this regulatory issue is not feasible to resolve the issue.

5.2

Exemption

Under an exemption, the NRC would issue various exemptions under 10 CFR 30.11,
“Specific exemptions,” to various regulatory provisions. To ensure public health and
safety, the NRC would evaluate the application against applicable standards and
regulations. The use of exemptions would not be desirable for the specific licensing of
items in this class of products because over time it would take more resources from an
applicant, licensee, and the NRC. Therefore, similar to guidance, reliance on
exemptions alone to resolve this regulatory issue is not feasible to resolve the issue.

5.3

Stakeholder Interactions

Currently, the only stakeholder input on this topic has been in response to the notice of
docketing and request for public comment on the petition (76 FR 36386; June 22,
2011). The NRC received one comment letter (ADAMS Accession No. ML11178A021)
from a member of the public opposing the petition. The commenter stated that the
current regulations do not place an unfair burden on the petitioner and have been in
place for some time. The NRC is making this regulatory analysis available to the public
and requesting comments. The agency will consider those comments in developing the
proposed rule.
In accordance with Management Directive 5.3, “Agreement State Participation in NRC
Working Groups,” (ML18073A142) the staff has provided early opportunity for
Agreement State engagement on this rulemaking effort. Specifically, the petition review
board included an Agreement State representative. During the process of developing
this regulatory analysis, the staff gave Agreement States an early opportunity to
participate in the proposed rule and this regulatory analysis and addressed their
comments, where appropriate, in finalizing the document. The staff has provided
updates during Organization of Agreement States/Conference of Radiation Control
Program Directors teleconferences as needed. For this rule, the staff added an
Agreement State representative who participated in the development of the proposed
rule.

5.4

Cumulative Effects of Regulation

The cumulative effects of regulation are an organizational effectiveness challenge that
results from a licensee or other affected entity implementing several complex positions,
programs, or requirements within a prescribed implementation period and with limited
available resources, including the ability to access technical expertise to address a
specific issue.
The proposed rulemaking activity for items containing byproduct material incidental to
production would reduce burden on current gemstone licensees, as well as on the NRC
staff reviewing any related license applications, by providing a more streamlined
regulatory structure for licensing. For all other irradiated products in this class, this rule
removes a barrier to product commercialization by providing a viable means to license
the product. This is a burden reduction to the licensee and NRC staff.
The proposed rulemaking activity for items containing byproduct material incidental to
production would increase burden on current PCTE and Silica Chip licensees, as well
as on the NRC staff reviewing any related license applications.
The staff provided early opportunity for Agreement State engagement on this
rulemaking effort in accordance with Management Directive 5.3, “Agreement State
Participation in NRC Working Groups,” (ML18073A142). Specifically, the petition
review board included an Agreement State representative. The proposed rulemaking
activity for items containing byproduct material incidental to production would increase
burden on Agreement States. There is no Tribal Nation involvement currently.

5.5

Environmental Analysis

This rulemaking would add new provisions to 10 CFR Part 30 and 10 CFR Part 32.
Pursuant to 10 CFR 51.21, “Criteria for and identification of licensing and regulatory
actions requiring environmental assessments,” the NRC will develop an environmental
assessment along with this rulemaking to determine whether issuing this rule will result
in any significant impacts. Backfitting is addressed in a separate document and is not
part of this regulatory analysis.
The Commission has preliminarily determined under NEPA and the Commission’s
regulations in Subpart A of 10 CFR Part 51, that the proposed amendments would not
be a major Federal action significantly affecting the quality of the human environment,
and therefore, an environmental impact statement is not required. The amendments
would amend 10 CFR Part 30 to add a new class exemption from licensing
requirements for items containing byproduct material incidental to their production and
to amend 10 CFR Part 32 to add new sections for distribution requirements. The
environmental impacts arising from the changes have been evaluated and would not
involve any significant environmental impact. As such, the rule would not result in
impacts to federally-listed threatened or endangered species or their critical habitat; the
NRC has determined that Section 7 consultation under the Endangered Species Act is
not necessary. Likewise, the NRC determined that the proposed rulemaking would not
have the potential to cause effects on or to historic properties. Therefore, the NRC has
determined that no further consultation is required under Section 106 of the National
Historic Preservation Act.

5.6

Support of Strategic Plan

The planned rulemaking supports the NRC’s 2018–2022 Strategic Plan (ADAMS
Accession No. ML18032A561) in relation to the strategic goal of ensuring the safe use
of radioactive materials. In the area of safety, the proposed rulemaking would support
NRC Safety Strategy 2, “Further risk-inform the current regulatory framework in
response to advances in science and technology, policy decisions, and other factors,
including prioritizing efforts to focus on the most safety-significant issues,” by providing
a regulatory path for potential licensees to obtain a distribution license for current and
future products that contain byproduct material incidental to production. In addition, the
planned rulemaking would support NRC Safety Strategy 3, “Enhance the effectiveness
and efficiency of licensing and certification activities to maintain both quality and
timeliness of licensing and certification reviews,” by developing a regulatory framework
that facilitates the ability of industry to manufacture and market useful, economical
products to support various applications while maintaining adequate protection of
health and safety.

5.7

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business
Regulatory Enforcement Fairness Act, requires the NRC to consider the impact of its
rulemakings on small entities and evaluate alternatives that would accomplish regulatory
objectives without unduly burdening small entities or erecting barriers to competition. In
developing the proposed rule, the staff evaluated how many small entities it anticipates this
rulemaking would affect and what steps the NRC can take to mitigate the economic impacts
on small entities.
The proposed rule would affect approximately 27 licensees that are subject to the rulemaking
and manufacture and/or distribute items containing byproduct material incidental to
production, some of which may qualify as small business entities as defined by
10 CFR 2.810. Based upon historical data, the staff estimates that approximately 2 out of the
27 estimated licensees subject to this rulemaking, may qualify as small business entities as
defined by 10 CFR 2.810. These 2 small business entities are anticipated to be gemstone
licensees. It is expected that all businesses will incur the same savings resulting from the
licensing process. These savings are a small percentage of the gross sales; therefore, we
conclude that there will be no significant economic impact to small business entities. On the
basis of the draft regulatory analysis conducted for this action the estimated averted cost of
the proposed rule for affected licensees is $40,000 at 7 percent. The NRC believes that the
selected alternative reflected in the proposed rule is the least burdensome, most flexible
alternative that would accomplish the NRC's regulatory objective.

6.
6.1

Summary of the Results
Summary of Quantified Net Benefits

The NRC estimates that the status quo will incur a cost of ($25,618,000) at a 7-percent
discount rate due to the cost of discontinuing rulemaking. These costs stem from the need to
prepare a SECY paper, a letter to the petitioner denying the petition, and an FRN.
Additionally, this option includes the costs to review initial license applications and
subsequent renewals, including costs to end users that are required to have a license. These

costs will become an averted cost if Alternative 2 is selected. This averted cost is shown in
Table 3.

6.2

Staff-Recommended Rulemaking

Table 3 shows the staff-recommended rulemaking actions. The Alternative 2 net
averted cost is $13,071,000, which comprises industry averted costs of $3,219,000,
NRC averted costs of $11,313,000, and Agreement State costs of ($1,460,000) to
update their regulations to be compatible with the NRC’s. Table 4 shows the net costs
to licensees, the NRC,and Agreement States.
Table 4

Alternative 2 Total Net Costs by Affected Entity
Net Benefit (Cost) by Affected Entity
(7% NPV in 2021 Dollars)
Agreement
Total
Industry
NRC
States
(2021$)

Description
Alternative 1 Status Quo - Do Nothing Different

Alternative 1 Net Benefits (Costs)
$0
$0
$0
$0
Alternative 2 Proceed with a Rulemaking Inclusive of Items Containing Byproduct Material Incidental to Production
(staff’s recommendation)
Item A: Rulemaking Implementation Costs Excluding
Rulemaking Termination Costs
Item B: PCTE Only

($337,000)

($1,460,000)

($1,797,000)

($7,239,000)

($184,000)

($7,423,000)

($61,000)

($84,000)

($145,000)

Item C: Silica Chip Only
Item D: Gemstone Only regulated §32.11(c) exemption
Averted Alternative 1 Costs (SECY, Letter, and FRN)
Alternative 2 Net Benefits (Costs)
a

$29,000

$40,000

$69,000

$10,489,000

$12,213,000

$22,702,000

$3,219,000

$11,648,000

($1,460,000)

$13,407,000

The total net benefit results are sensitive to the timing of when costs and benefits occur and to the discount rate applied.
Benefits and averted costs are positive. Costs are (negative).
There may be differences between table summations due to rounding.

b
c

Based on the cost estimates shown in Table 3, the NRC concludes that the rulemaking
alternative inclusive of all items containing byproduct material incidental to production is
the best course of action that addresses the majority of concerns, because the
quantitative and qualitative benefits discussed in Section 6.2 and 6.4 exceed the cost of
implementing this rulemaking.
The new provisions would become applicable to current licensees at the time of their
next license renewal. These new provisions will be substantially less burdensome
because the licensee would not need a special exemption under the new provision.
regulations that affect small entities.

6.3

Benefits

The staff expects the proposed action to provide the following benefits:
•

Establish a regulatory framework and allow new or current products under this
category to be licensed without product-specific exemptions, each of which would
require additional rulemaking or need to be reviewed on a case-by-case basis.

•

Provide an appropriate pathway for licensing these beneficial irradiated products that
19

are used in a wide variety of applications. Items like PCTE membranes can be made
without creating byproduct material incidental to production; however, the industry
prefers to use this method to create membranes with uniform pore size and
distribution.
•

Ensure consistency for regulating different products in this class.

•

As described in Table 1, avert an estimated cost at 7 percent of $3.2 million to
Industry, $11.6 million averted cost to the NRC and a cost of ($1.5 million) to the
Agreement States, for a total net averted cost of $13.4 million by pursuing
rulemaking, which includes the cost of updating guidance and developing a
compliance guide for regulations that affect small entities.

6.4

Non-quantified Benefits

The rule would affect the following attributes. These inventory of attributes are listed in
NUREG/BR-0058 Revision 5.
Improvements in Knowledge. This attribute accounts for improvements in knowledge
acquired as the industry and the staff gain experience with new technology before its
incorporation into Part 30 and Part 32 and by permitting licensees to avoid costs in
asking for incorporating new technologies.
Regulatory Efficiency. This attribute accounts for regulatory and compliance
improvements resulting from the implementation of Alternative 2 relative to the
regulatory baseline. Alternative 2 would continue the best practice of aligning NRC
regulations with ICBMIP licensing standards, thereby providing the industry with the
regulatory provisions for which it has sought permission via relief and alternative
requests. This rulemaking would reduce the effort the industry expends generating
these requests and considering alternative means to accomplish the goals of these
provisions.
Other Considerations. This attribute accounts for considerations not captured in the
preceding attributes. Specifically, this attribute accounts for how Alternative 2 meets
specific requirements of the Commission, helps achieve NRC policy, and provides other
advantages or detriments.
Attributes with No Effects. Attributes not expected to be affected under any of the
alternatives include considerations of public health (routine), offsite property, onsite
property, other governments, the public, safeguards and security, and the environment.

6.5

Uncertainty Analysis

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

6.5.1

Uncertainty Analysis Assumptions

As this regulatory analysis uses estimates of values that are sensitive to unique
certificate holders’ situations, the staff analyzed the variables that have the greatest
amount of uncertainty. To perform this analysis, the staff used a Monte Carlo simulation
analysis using the @Risk® software program. This was done to determine the
robustness of the costs and net benefits of the proposed rule. The NRC examined how
anticipated savings change due to uncertainties associated with the NRC’s analytical
assumptions and input data. As mentioned in Section 3.1, the NRC used Monte Carlo
simulation to examine the impact of uncertainty on the estimated net benefits of the
proposed rule.
Monte Carlo simulations involve introducing uncertainty into the analysis by replacing
the point estimates of the variables used to estimate base case costs and benefits
with probability distributions. By defining input variables as probability distributions
instead of point estimates,the influence of uncertainty on the results of the analysis (in
other words, the net benefits) can be effectively modeled.
The probability distributions chosen to represent the different variables in the analysis
were bounded by the range-referenced input and the staff’s professional judgment.
When defining the probability distributions for use in a Monte Carlo simulation,
summary statistics are used tocharacterize the distributions. These summary statistics
include the minimum, most likely, andmaximum values of a program evaluation and
review technique (PERT) distribution. The staffused the PERT distribution to reflect
the relative spread and skewness of the distribution defined by the three estimates, the
minimum, most likely, and maximum. Figure A-1 of this document provides the
probability distribution function and the descriptivestatistics of the inputs used in the
uncertainty analysis.

6.5.2

Uncertainty Analysis Results

The NRC performed the Monte Carlo simulation by repeatedly calculating the results
10,000 times. Appendix A provides the inputs used in the uncertainty analysis and additional
information regarding the uncertainty analysis results.
For each iteration, the variable values in Appendix A were chosen randomly from the
probabilitydistributions that define the input variables. The values of the output
variables were recorded for each iteration, and these resulting output variable values
were used to define the resultant probability distribution.
The results of the uncertainty analysis of Alternative 2 net costs using a 7-percent
discount rate are provided graphically in Figure A-1. This figure displays the histogram
of the incremental netcost for rulemaking to resolve the identified issues. The
uncertainty analysis graph showing thenet result is reported in 2021 dollars. The
analysis shows that Alternative 2 is cost beneficial for 96 percent of the 10,000
simulations with a 90-percent confidence interval that the net costs are between
($5.5 million) and $47.4 million using a 7-percent discount rate.

Figure 1

Incremental Net Costs for Alternative 2 (7-Percent Discount Rate)

Figure 2 shows a tornado diagram that identifies the key variables whose uncertainty
drives the largest impact on net benefits for this recommended alternative. Figure 2
ranks the variables based on their contribution to cost uncertainty.
The estimate that has the greatest variation in the overall results is the Alternative 2
Averted Costs Derived from Alternative 1 Status Quo PCTE End Users Initial License
applications relating to the complexity of the expected applications developed by
industry applicants. The uncertainty in this variable would result in a change to the
mean of $11.8 million, the difference in averted costs that ranges between $8.2 million
to $20.0 million with a 90 percent confidence level.
The estimate that has the second greatest variation in the overall results is the
Alternative 2 Averted Costs Derived from Alternative 1 Status Quo NRC Review of
PCTE End Users Initial License applications. The uncertainty in this variable would
result in a change to the mean of $11.3 million, the difference in averted costs that
ranges between $8.2 million to $19.5 million with a 90 percent confidence level.
The estimate that has the third greatest variation in the overall results is the NRC
Review of PCTE End Users License Applications. The uncertainty in this variable
would result in a change to the mean of $7.8 million, the difference in costs that ranges
$8.5 million to $16.3 million with a 90 percent confidence level.

6.6

Figure 2

6.7

Summary of Uncertainty Analysis

Alternative 2 Cost Drivers (7-Percent Discount Rate)

Decision Rationale

Relative to Alternative 1 the Status Quo alternative, Alternative 2 results in a net benefit
of approximately $13.4 million (total present value), assuming a 7-percent discount rate,
or $20.0 million assuming a 3-percent discount rate.
The NRC estimates that the rulemaking would take approximately 2 years to complete
from the proposed rule to the final rule and require the time of 4.2 full-time equivalent
staff. The rulemaking implementation would result in a cost of ($337,000) to the NRC
using a 7-percent discount rate. The rulemaking implementation would result in a cost
of ($1,460,000) to the Agreement States using a 7-percent discount rate. This results
in a total implementation cost of ($1,797,000) to the NRC and the Agreement States
using a 7-percent discount rate, which is shown as a separate line item in Table 1,
Alternative 2, Item A. Adding the costs for Item A Implementation ($1,797,000), Item B
PCTE ($7,423,000), Item C Silica Chip ($145,000); Item D Gemstones averted costs
$69,000; and the Averted Alternative 1 costs of $22,702,000, yield the final net averted
cost for Alternative 2 is $13,407,000.

Table 5

Summary of Totals

Net Monetary Savings or (Costs)—Total
Present Value
Alternative 1: Status Quo
$0
Alternative 2: 'Alternative 2 Proceed with a
Rulemaking Inclusive of Items Containing
Byproduct Material Incidental to Production
(staff’s recommendation)
Industry: (all provisions)
$3.2 million using a 7% discount rate
$6.1 million using a 3% discount rate
NRC: (all provisions)
$11.6 million using a 7% discount rate
$15.6 million using a 3% discount rate
Agreement States: (all provisions)
($1.5 million) using a 7% discount rate
($1.7 million) using a 3% discount rate
Net Benefit (Cost): (all provisions)
$13.4 million using a 7% discount rate
$20.0 million using a 3% discount rate

Nonquantified Benefits or (Costs)
None
Benefits:
• Improvements in Knowledge: This attribute
accounts for improvements in knowledge
acquired as the industry and the staff gain
experience with new technology before its
incorporation into Part 30 and Part 32 and by
permitting licensees to avoid costs in asking for
incorporating new technologies.
• Regulatory Efficiency: This attribute accounts
for regulatory and compliance improvements
resulting from the implementation of Alternative
2 relative to the regulatory baseline.
Alternative 2 would continue the best practice
of aligning NRC regulations with ICBMIP
licensing standards, reducing the effort the
industry expends generating these requests
and considering alternative means to
accomplish the goals of these provisions.
• Other Considerations: This attribute accounts
for considerations not captured in the
preceding attributes. Specifically, this attribute
accounts for how Alternative 2 meets specific
requirements of the Commission, helps
achieve NRC policy, and provides other
advantages.
• Attributes with No Effects: Attributes not
expected to be affected under any of the
alternatives include considerations of public
health (routine), offsite property, onsite
property, the public, and safeguards and
security.
Costs:
Nonquantified Costs: If the staff has
underestimated the number or the complexity of
these eliminated submittals, then the averted
costs would increase proportionally, causing the
quantified net costs of Alternative 2 to decrease.

6.9

Implementation

The rule is expected to become effective in 2024. All monetized costs are expressed in
2021 dollars. Ongoing costs of operation related to the alternative being analyzed are
assumed to begin no earlier than 30 days after publication of the final rule in the Federal
Register unless otherwise stated, and they are modeled on an annual cost basis.

Agreement States have up to 3 years from the effective date of the rule to implement but
are expected to implement the rule sooner.
The NRC assumes that the proposed rule would become effective 30 days after its
publication in the Federal Register in 2024.

References

Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of General
Applicability to Domestic Licensing of Byproduct Material.”

Title 10 of the Code of Federal Regulations (10 CFR) Part 32, “Specific Domestic
Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material.”

PRM-30-65, “Petition for Rulemaking Pursuant to 10 C.F.R. § 2.802 on Behalf of
GE Osmonics Inc.,” April 18, 2011 (ADAMS Accession No. ML120250133).

GE Osmonics, Inc., “Polymer Track Etch Membrane 10 C.F.R. § 32.14—Manufacture
and Distribution Product Safety Information,” received March 20, 2012 (ADAMS
Accession No. ML120800277).

GE Osmonics, Inc., “Environmental Report—Polymer Track Etch Membrane—
10 CFR 30.15,” received March 20, 2012 (ADAMS Accession No.
ML120800264).

SECY-87-186A, “Distribution of Radioactive Gems Irradiated in Reactors to
Unlicensed Persons (Follow-Up to SECY-87-186),” October 5, 1987 (ADAMS
Accession No. ML092400170), and associated staff direction (ADAMS
Accession No. ML12289B143).

Petition for Rulemaking Submitted by Annette User on Behalf of GE Osmonics,
Inc.,” on September 14, 2012, 10 CFR Part 30, Federal Register (FR) (77 FR
56793).

“Consumer Product Policy Statement,” 79 FR 2907, January 16, 2014 (ADAMS
Accession No. ML13191A732).

NUREG-1556, Volume 8, Revision 1, “Consolidated Guidance about Materials
Licenses:Program-Specific Guidance About Exempt Distribution Licenses,” June
2018 (ADAMS Accession No. ML18158A165).

10.

International Atomic Energy Agency, OECD Nuclear Energy Agency, “Radiation
Safety for Consumer Products,” IAEA Safety Standards Series No. SSG-36,
January 2016.

11.

International Atomic Energy Agency, IAEA Safety Standards Series,
“Radiation Protection and Safety of Radiation Sources: International Basic
Safety Standards—General Safety Requirements Part 3 No. GSR Part 3,” July
2014.

12.

Management Directive 5.3, “Agreement State Participation in NRC
Working Groups,”June 22, 2016 (ADAMS Accession No.
ML18073A142). “Agreement State Program Policy Statement;
Correction,” 82 FR 48535,October 18, 2017.

13.

NUREG/BR-0058, Revision 5, “U.S. Nuclear Regulatory Commission
Guidance on Performing Cost-Benefit Analyses, April 2017 (ADAMS
Accession No. ML 17100A480).

14.

NUREG-1614, Vol. 7, “Strategic Plan: Fiscal Years 2018–2022,” February
2018 (ADAMS Accession No. ML18032A561).

Appendix A: Assumptions and Assessment Supporting the Cost Analysis
Table A-1 Data Table
Description

Mean
Estimate

Distribution

Low Estimate

Best
Estimate

High Estimate

Alternative 1 Status Quo - Do Nothing Different

Alternative 2 Proceed with a Rulemaking Inclusive of Items Containing Byproduct Material Incidental to Production (staff’s
recommendation)
Alternative 2- Averted Cost Derived from Alt 1
Status Quo
Averted NRC Rulemaking Discontinuation Costs
(SECY, Letter, and FRN)
Rulemaking Discontinuation (NRC)
NRC Hours
NRC Labor Rate
RESERVED
Averted NRC Review of PCTE End User Initial
License Applications
Number of PCTE End User Licensees
Time (Hours)/ NRC review of Licensee End Users
Initial Applications
Time (Hours)/ NRC review of Licensee End Users
Renewal Applications
NRC Labor Rate
RESERVED
Averted NRC Review of PCTE Manufacturers
and/or Distributors Initial License Applications
Number of PCTE Manufacturers and/or
Distributors
Time (Hours)/ NRC review of Manufacturers
and/or Distributors Initial Applications
Time (Hours)/ NRC review of Manufacturers
and/or Distributors Renewal Applications
NRC Labor Rate
RESERVED
Averted PCTE End User Licensees Initial License
Submittal
Number of PCTE End User Licensees
Time (Hours)/ Licensee End Users Initial
Applications
Time (Hours)/ Licensee End Users Renewal
Applications
Licensee Average Labor Rate
RESERVED
Averted PCTE Manufacturers and/or Distributors
Initial License Submittal
Number of PCTE Manufacturers and/or
Distributors
Time (Hours)/ Manufacturers and/or Distributors
Initial Applications
Time (Hours)/ Manufacturers and/or Distributors
Renewal Applications
Licensee Average Labor Rate
RESERVED
Agreement States Rulemaking Implementation
Costs

1
820
$137

Pert

738

1
820
$137

902

2,000

Pert

1,600

2,000

2,400

Pert

120

Pert

$137

Pert

100

Pert

100

110

Pert

$137

2,000

Pert

1,600

2,000

2,400

Pert

120

Pert

$100

Trigen

$59

$86

$146

Pert

100

Pert

100

110

Pert

$100

Trigen

$59

$86

$146

A-27

Affected Agreement States (#)

Number of Reports per A/S processed
Time (Hours)/ Agreement State Report
Agreement States Labor Rate
RESERVED

1
527
$95

Pert
Pert

316
86

1
527
$95

738
105

Pert

60
$100

Pert
Trigen

54
$59

60
$86

66
$146

1
2,718
$137

Pert

0.9

1
2,718
$137

1.1

Pert

$100

Trigen

$59

$86

$146

Pert

NRC Rulemaking Implementation
RESERVED
Alternative 2- Licensee & NRC Rulemaking Costs
Item A: Rulemaking Implementation
Item A (Licensee) Rulemaking and use existing
guidance
Rulemaking and use existing guidance (#
Licensees)
Time (Hours)/Licensee
Licensee Average Labor Rate
RESERVED
Item A NRC Rulemaking
Rulemaking and use existing guidance (NRC)
Time (Hours)/NRC
NRC Labor Rate
RESERVED
Item B: PCTE Only
PCTE Licensing
PCTE Manufacturers and/or Distributors (#
Licensees Submittals)
PCTE Licensee Hours (Licensee Application
Development)
PCTE Licensee Labor Rate
RESERVED
NRC Licensing PCTE Entities
PCTE (NRC)
NRC Review and Processing Time per Submittal
(Hours)
NRC Labor Rate
RESERVED
Licensee PCTE End User Entities (not
Manufacturers and/or Distributors)
Number of PCTE End User Licensees
Time (Hours)/ NRC review of PCTE Licensee
End Users Applications

$137

2,000

1,600

2,000

2,400

Pert

120

$100

Trigen

$59

$86

$146

Pert

Time (Hours)/ NRC review of PCTE End User
Entities

100

Pert

100

110

NRC Labor Rate

$137

PCTE Licensee Labor Rate
RESERVED
NRC Licensing PCTE End User Entities
Number of PCTE End User Entities

RESERVED
Item C: Silica Chip Only
Item C (Licensee) Silica Chip Entity Initial License
Application Submittal

A-28

$137

Licensef Number of Silica Chip Licensee
Submittals
Review and Processing Time per Submittal
(Hours) of Silica Chip Licensees
Silica Chip Licensee Labor Rate
RESERVED
Item C NRC Licensing Silica Chip Entities
NRC Review of Licensing Silica Chip Entities
Silica Chip Time (Hours)/NRC
NRC Labor Rate
RESERVED
Item D: Gemstone Only regulated §32.11(c)
exemption
Item D Licensee Gemstone Exemptions Averted
Number of Gemstone Exemptions (# Licensees)
Gemstone Entity Licensee Hours/Report
Gemstone Entity Licensee Labor Rate
RESERVED
Item D NRC Gemstone Exemption Processing
Averted
NRC Review of Gemstone Submittals Only
NRC Gemstone Review and Processing Time
(Hours)
NRC Labor Rate
RESERVED

Pert

$100

Pert

9
60
$137

Pert
Pert

8
54

9
60
$137

10
66

9
40
$100

Pert
Pert
Trigen

8
36
$59

9
40
$86

10
44
$146

Pert

$100

$137

For cost analysis considerations, the staff estimates for Alternative 2 Averted Cost Derived from
Alternative 1 NRC Rulemaking Discontinuation an averted cost of $92 thousand using a 7
percent discount rate to discontinue rulemaking. This cost includes preparing a SECY, a letter
to the petitioner to inform them of thedenial of the petition, and an FRN. This cost is shown in
Table A-2.
Table A-2 Alternative 2 Averted Cost Derived from Alternative 1 Status Quo - Do Nothing
Different -- NRC Rulemaking Discontinuation Cost
Year

Description

2024

Averted NRC Rulemaking
Discontinuation Costs SECY, Letter, and
FRN)

NRC
Hours

NRC Labor
Rate

820

$137

Undiscounted

Net Benefits (Costs)

7% NPV

3% NPV

$112,340

$91,703

$102,807

$112,340

$91,703

$102,807

For cost analysis considerations, the staff estimates an averted cost for Alternative 2 Averted
Cost Derived from Alternative 1 NRC review of PCTE End User License Applications a cost of
$12.0 million using a 7 percent discount rate. The estimated number of PCTE end user
licensees is 4,000. This averted cost is shown in Table A-3.
Table A-3 Alternative 2 Averted Cost Derived from Alternative 1 Status Quo - Do Nothing
Different -- NRC Review of PCTE End User License Applications
Year
2024
2025

Description
Averted NRC Review of PCTE End
User Initial License Applications
Averted NRC Review of PCTE End
User Initial License Applications

Number of PCTE
End User Initial
License
Applications

NRC
Review
Hours

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

400

$137

$2,740,000

$2,236,656

$2,507,488

400

$137

$2,740,000

$2,090,333

$2,434,455

A-29

2026
2027
2028
2038

Averted NRC Review of PCTE End
User Initial License Applications
Averted NRC Review of PCTE End
User Initial License Applications
Averted NRC Review of PCTE End
User Initial License Applications
Averted NRC Review of PCTE End
User Initial License Applications
Net Benefits (Costs)

400

$137

$2,740,000

$1,953,582

$2,363,548

400

$137

$2,740,000

$1,825,778

$2,294,707

400

$137

$2,740,000

$1,706,334

$2,227,871

2,000

$137

$6,850,000

$2,168,535

$4,144,363

$20,550,000

$11,981,218

$15,972,431

4,000

For cost analysis considerations, the staff estimates for Alternative 2 Averted Cost Derived from
Alternative 1 NRC review of PCTE manufacturers and distributors license applications an
averted cost of $140 thousand using a 7 percent discount rate. The NRC estimated that there
are nine PCTE Manufacturers and/or distributor licensees. This averted cost is shown in
Table A-4.
Table A-4 Alternative 2 Averted Cost for NRC Review of PCTE Manufacturers and/or
Distributors Initial License Applications
Year

2024

2038

Description

Number of PCTE
Manufacturers
and/or Distributors

NRC
Review
Hours

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

100

$137

$123,300

$100,650

$112,837

100

$137

$123,300

$39,034

$74,599

$139,683

$187,435

Averted NRC Review of PCTE
Manufacturers and/or
Distributors Initial License
Applications
Averted NRC Review of PCTE
Manufacturers and/or
Distributors Initial License
Applications
Net Benefits (Costs)

$246,600

The staff estimates an averted cost of $10.3 million at a 7-percent discount rate for Alternative 2
Averted Cost Derived from Alternative 1. The NRC estimates that there would be 2,000 PCTE
end user licensees with one licensee renewal. This averted cost is shown in Table A-5.
Table A-5 Alternative 2 Averted Cost Derived from Alternative 1 Status Quo - Do Nothing
Different -- PCTE End User Licensees StatusQuo Expenses
Year

2024
2025
2026
2027
2028
2038

Description
Averted PCTE End User
Licensees Initial License
Submittal
Averted PCTE End User
Licensees Initial License
Submittal
Averted PCTE End User
Licensees Initial License
Submittal
Averted PCTE End User
Licensees Initial License
Submittal
Averted PCTE End User
Licensees Initial License
Submittal
Averted PCTE End User
Licensees Renewal
License Submittal

Number
of PCTE
End User
Licensees

Licensee End
Users Initial
Applications
Hours

Licensee
Average
Labor
Rate

Undiscounted

7% NPV

3% NPV

400

$100

$2,004,155

$1,635,988

$1,834,086

400

$100

$2,004,155

$1,528,960

$1,780,666

400

$100

$2,004,155

$1,428,935

$1,728,802

400

$100

$2,004,155

$1,335,453

$1,678,448

400

$100

$2,004,155

$1,248,087

$1,629,562

2,000

$100

$10,020,776

$3,172,321

$6,062,734

A-30

Net Benefits (Costs)

4,000

$20,041,552

$10,349,744

$14,714,298

The staff estimates an averted cost of $140 thousand at a 7-percent discount rate for Alternative
2 Averted Cost Derived from Alternative 1. The analysis estimates nine PCTE manufacturers
and distributors would undergo initial licensing in 2024 and license renewal in 2038. This
averted cost is shown in Table A-6.
Table A-6 Alternative 2 Averted Cost Derived from Alternative 1 Status Quo - Do Nothing
Different -- PCTE Manufacturers andDistributors Status Quo Expenses
Year

2024

2038

Description

Number of
PCTE
Manufacturers
and/or
Distributors

Manufacturers
and/or
Distributors Initial
Applications
Hours

Licensee
Average
Labor Rate

Undiscounted

7% NPV

3% NPV

100

$137

$123,300

$100,650

$112,837

100

$137

$123,300

$39,034

$74,599

$139,683

$187,435

Averted PCTE
Manufacturers and/or
Distributors Initial
License Submittal
Averted PCTE
Manufacturers and/or
Distributors Initial
License Submittal
Net Benefits (Costs)

$246,600

For cost analysis considerations, the staff estimates Agreement States rulemaking
implementation costs of ($1.5 million) at a 7-percent discount rate as shown in Table A-7.
Table A-7 Alternative 2 - Agreement States Rulemaking Implementation Costs
Year
2024
2025
2026

Description

Number of
Agreement
States

Rulemaking
Hours

Agreement
States
Labor Rate

Undiscounted

7% NPV

3% NPV

527

$95

($652,662)

($532,767)

($597,278)

527

$95

($652,662)

($497,913)

($579,882)

527

$95

($602,457)

($429,544)

($519,685)

($1,907,782)

($1,460,223)

($1,696,845)

Agreement States
Rulemaking
Agreement States
Rulemaking
Agreement States
Rulemaking
Net Benefits (Costs)

For cost analysis considerations, the staff estimates for NRC rulemaking implementation costs
of ($672 thousand) at a 7-percent discount rate as shown in Table A-8.
Table A-8 NRC Rulemaking Implementation Cost
Year

Activity

Hours

NRC
hourly rate

Total Cost

Undiscounted

7% NPV

3% NPV

2022

Develop/issue RG for final rule

388

$137

($53,197)

($49,716)

($51,647)

2022

Develop/issue final rule

971

$137

($132,991)

($124,291)

($129,118)

2023

Develop/issue Comment
Resolution for final rule

388

$137

($53,197)

($46,464)

($50,143)

A-31

2023

Complete final rule

971

Net (Cost) Benefit:

$137

2,718

($132,991)

($116,160)

($125,357)

($372,376)

($336,631)

($356,265)

The staff estimates an average of 9 PCTE entities will apply for licenses under the new
regulations. To comply with the new regulations, PCTE licensees will need to submit aninitial
application and a renewal application at 15 years. The estimated number of hours per
application ranges from a low of 54 hours to a high estimate of 66 hours with a mean value of
60 hours as shown in Table A-9. This results in a cost of ($61 thousand) at a 7-percent
discount rate as shown in Table A-9.
Table A-9 PCTE Licensee Implementation Costs
Year

Description

2024
2038

PCTE Licensing
PCTE Licensing
Net Benefits (Costs)

Number of
PCTE Licenses

PCTE
Licensee
Hours

9
9

60
60

Lab
or
Rat
e
$100
$100

Undiscounted

7% NPV

3% NPV

($54,112)
($54,112)
($108,224)

($44,172)
($17,131)
($61,302)

($49,520)
($32,739)
($82,259)

The staff estimates that PCTE entities will submit an initial application and a renewal application
at 15 years. The estimated number of hours to review the initial and renewal application and
issue the licenses ranges from a low of 54 hours to a high estimate of 66 hours with a mean
value of 60 hours. This results in a cost of ($84 thousand) at a 7-percent discount rate as
shown in Table A-10.
Table A-10 NRC Costs to Issue PCTE Licenses
Year

Description

2024
2038

NRC PCTE Licensing
NRC PCTE Licensing
Net Benefits (Costs)

Number of
PCTE Licenses
9
9

PCTE
License
eHours
60
60

Labor
Rate

Undiscounted

7% NPV

3% NPV

$137
$137

($73,980)
($73,980)
($147,960)

($60,390)
($23,420)
($83,810)

($67,702)
($44,759)
($112,461)

The staff estimates an average of 2,000 licensee PCTE manufacturers and/or distributor end
user entities will apply for licenses under the new regulations. The number of hours per
application ranges from a low of 20 hours to a high estimate of 140 hours with a mean value of
50 hours. This results in a cost of ($7.2 million) at a 7-percent discount rate as shown in
Table A-11.
Table A-11 Licensee PCTE End User Entities (not Manufacturers and/or Distributors)
Year

2024
2025
2026

Description
Licensee PCTE End User
Entities (not Manufacturers
and/or Distributors)
Licensee PCTE End User
Entities (not Manufacturers
and/or Distributors)
Licensee PCTE End User
Entities (not Manufacturers
and/or Distributors)

Number of
PCTE End
User Licensees

NRC
Review
Hours

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

400

$100

($2,004,155)

($1,635,988)

($1,834,086)

400

$100

($2,004,155)

($1,528,960)

($1,780,666)

400

$100

($2,004,155)

($1,428,935)

($1,728,802)

A-32

2027
2028

Licensee PCTE End User
Entities (not Manufacturers
and/or Distributors)
Licensee PCTE End User
Entities (not Manufacturers
and/or Distributors)
Net Benefits (Costs)

400

$100

($2,004,155)

($1,335,453)

($1,678,448)

400

$100

($2,004,155)

($1,248,087)

($1,629,562)

($10,020,776)

($7,177,423)

($8,651,564)

2,000

The staff estimates an average of 9 NRC reviews of NRC Costs for PCTE Manufacturers and/or
Distributor End User Entities that will apply for licenses under the new regulations. The number
of hours per application ranges from a low of 90 hours to a high estimate of 110 hours with a
mean value of 100 hours. This results in a cost of ($101 thousand) a 7-percent discount rate as
shown in Table A-12.
Table A-12 NRC Costs for Licensing PCTE End User Entities
Year

2024

Description

End User
Entities (not
Manufacturers
and/or
Distributors)

NRC
Hours

NRC Labor
Rate

Undiscounted

7% NPV

3% NPV

100

$137

($123,300)

($100,650)

($112,837)

NRC Licensing PCTE
End User Entities
Net Benefits (Costs)

($123,300)

($100,650)

($112,837)

The staff estimates an average of 9 Silica Chip entities will apply for licenses under the new
regulations. To comply with the new regulations, Silica Chip licensees will need to submit an
initial application and a renewal application at 15 years. The estimated number of hours per
application ranges from a low of 54 hours to a high estimate of 66 hours with a mean value of
60 hours as shown in Table A-13. This results in a cost of ($61 thousand) at a 7-percent
discount rate as shown in Table A-13.
Table A-13 Silica Chip Entity Implementation Costs
Year
2024
2038

Description

Number of
Silica Chip
License
Applications

Licensee
Hours

Labor
Rate

Undiscounted

7% NPV

3% NPV

$100

($54,112)

($44,172)

($49,520)

$100

($54,112)
($108,224)

($17,131)
($61,302)

($32,739)
($82,259)

Silica Chip Entity Initial License
Application Submittal
Silica Chip Entity Licensing
Net Benefits (Costs)

The staff estimates that nine silica chip entities will submit an initial application and a renewal
application at 15 years. The estimated number of hours to review the initial and renewal
application and issue the licenses ranges from a low of 54 hours to a high estimate of 66 hours
with a mean value of 60 hours This results in a cost of ($84 thousand) at a 7-percent discount
rate as shown in Table A-14.
Table A-14 NRC Costs to Issue Silica Chip Licenses
Year
2024
2038

Description
Item C NRC Licensing Silica
Chip Entities
Item C NRC Licensing Silica
Chip Entities

Number of
Silica Chip
Applications

Silica Chip
Time
(Hours)/NRC

NRC
Labor
Rate

Undiscounted

7% NPV

3% NPV

$137

($73,980)

($60,390)

($67,702)

$137

($73,980)

($23,420)

($44,759)

A-33

Net Benefits (Costs)

($147,960)

($83,810)

($112,461)

The staff estimates an average of 9 gemstone licensees complying with the new regulations.
The number of hours saved, when complying with the new regulations, ranges from a low of
36 hours to a high estimate of 44 hours with a mean value of 40 hours. This results in an
averted cost of $29 thousand a 7-percent discount rate as shown in Table A-15.
Table A-15 Averted Gemstone Entity Implementation
Year
2024

Description
Licensee Gemstone Exemptions
Averted
Net Benefits (Costs)

Number of
Gemstone
Exemptions
Averted

Hours

Labor
Rate

Undiscounted

7% NPV

3% NPV

$100

$36,075

$29,448

$33,014

$36,075

$29,448

$33,014

The staff estimates an average of 9 gemstone licensees complying with the new regulations.
The number of hours saved to issue exemptions covering gemstone entities ranges from a low
of 36 hours to a high estimate of 44 hours with a mean value of 40 hours. This results in an
averted cost of $40 thousand a 7-percent discount rate as shown in Table A-16.
Table A-16 Averted NRC Gemstone Exemption Costs
Year

Description

Number of
Gemstone
Exemptions Averted

Hour
s

2024

NRC Exemption
Processing
Averted
Net Benefits (Costs)

A-34

NRC Labor Undiscounted
Rate
$137

7% NPV

3% NPV

$49,320

$40,260

$45,135

$49,320

$40,260

$45,135

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