SECY-19-0125, Regulatory Basis for Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials (SRM-SECY-19-0125)

Regulatory Basis for Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials (SRM-SECY-19-0125)

ML21235A480
Person / Time
Issue date:	04/22/2022
From:	Maupin C Office of Nuclear Material Safety and Safeguards
To:
Maupin, C
Shared Package
ML21235A416	List: ML21235A471 SECY-19-0125, Regulatory Basis for Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials (SRM-SECY-19-0125)
References
NRC-2017-0031, RIN 3150-AK52, SRM-SECY-19-0125
Download: ML21235A480 (44)

Text

DECOMMISSIONING FINANCIAL ASSURANCE REQUIREMENTS FOR SEALED AND UNSEALED RADIOACTIVE MATERIALS

Regulatory Basis Docket ID: NRC-2017-0031 RIN: 3150-AK52

April 2022

[ML21235A480]

[This page is left intentionally blank. ]

Contents Abbreviations and Acronyms.................................................................................................. vii Definition of Terms (as Used in this Document)..................................................................... ix Units Conversion Table............................................................................................................. xi Executive Summary................................................................................................................. xiii

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

2. Background and Existing Regulatory Framework........................................................... 3 2.1 Relevant NARM Statutes and Regulations....................................................................... 3 2.1.1 The Energy Policy Act of 2005................................................................................ 3 2.1.2 The NARM Rule...................................................................................................... 3 2.2 NRC Decommissioning Financial Assurance Regulations................................................ 4 2.2.1 Final Rule of 1988................................................................................................... 4 2.2.2 Amendments of Interest.......................................................................................... 5 2.3 The Existing Regulatory Framework................................................................................. 7 2.3.1 NRC Regulatory Program....................................................................................... 8 2.3.2 Agreement State Regulatory Program.................................................................... 8 2.4 Requests for Revisions to the NRCs Regulations............................................................ 8 2.4.1 NRC Advisory Committee on the Medical Uses of Isotopes................................... 8 2.4.2 Organization of Agreement States PetitionPRM-30-66....................................... 9 2.4.3 SECY-19-0125 and Associated SRM-SECY-19-0125.......................................... 10

3. Statement of Regulatory Concerns.................................................................................. 12 3.1 Unaligned Appendix B Values and Radionuclide Listings............................................... 12 3.2 Applying the Generic Default Values in Appendix B to 10 CFR Par t 30......................... 12 3.3 Processing Exemption Requests.................................................................................... 13 3.4 Reviewing Plans for Unlisted Radionuclides................................................................... 13 3.5 Revising 10 CFR 30.35 with a New Methodology and Category for G enerators............ 14 3.6 Unaligned Appendix Title and Purpose........................................................................... 14 3.7 Unaligned Listing of Isotopes and Decommissioning Criteria......................................... 14

4. Evaluation of Rulemaking Alternatives........................................................................... 14 4.1 Alternative 1The Status Quo....................................................................................... 14 4.2 Alternative 2Update the List of Radionuclides and the Values i n Appendix B to 10 CFR Part 30 Table (NRC Selected).................................................... 15 4.3 Alternative 3Partially Update Appendix B to 10 CFR Part 30 (Add Unlisted NARM Radionuclides and Other Radionuclides Not Currently Listed to the Existing Table in Appendix B)............................................... 16

iii 4.4 Alternative 4Develop a New Process for Assessing Decommissioning Funding Costs.................................................................. 16 4.5 Alternative 5Update Appendix B to 10 CFR Part 30 and Develop a New Process for Assessing Decommissioning Funding Cos ts (Combines Alternative 2 and Alternative 4 - Two rulemakings)...................................... 18

5. Basis for Proposed Changes............................................................................................ 18 5.1 Proposed Changes......................................................................................................... 19 5.2 Benefits of the Rulemaking............................................................................................. 19 5.2.1 A More Risk-Informed Regulation......................................................................... 19 5.2.2 Reduces or Eliminates Exemption Requests........................................................ 19 5.2.3 Addresses Emerging Technologies....................................................................... 20 5.2.4 Alignment of Title and Purpose............................................................................. 20 5.2.5 Alignment of Listing of Radionuclides and Decommissioning Crite ria................... 21

6. Backfitting and Issue Finality Analysis........................................................................... 22

7. Stakeholder Involvement.................................................................................................. 22

8. Cost/Impact Considerations............................................................................................. 23 8.1 Applicability..................................................................................................................... 23 8.2 Analysis Assumptions..................................................................................................... 24 8.3 Affected Entities.............................................................................................................. 24 8.3.1 NRC....................................................................................................................... 24 8.3.2 Agreement States.................................................................................................. 24 8.3.3 Licensees.............................................................................................................. 25 8.3.4 Tribal Nations........................................................................................................ 25 8.4 Summary of Alternatives and Cost.................................................................................. 25

9. Uncertainty Analysis......................................................................................................... 2 6 9.1 Uncertainty Analysis Assumptions.................................................................................. 27 9.2 Uncertainty Analysis Inputs............................................................................................. 27 9.3 Uncertainty Analysis Results........................................................................................... 27 9.4 Sensitivity Analysis.......................................................................................................... 28

10. Rulemaking Cost Justification......................................................................................... 29

11. Cumulative Effects of Regulation.................................................................................... 30

12. Regulatory Flexibility Act.................................................................................................. 30

13. Environmental Analysis.................................................................................................... 30

14. NRC Strategic Plan............................................................................................................ 31

15. Decision Rationale............................................................................................................. 31

16. References......................................................................................................................... 31

iv Appendix AQuantities of Licensed Material Used to Assess Financial Assurance for Decommissioning (Proposed Update d Table).............. A-1 Appendix BData Tables...................................................................................................... B-1 Appendix CSummary and Tables of Costs for Each Alternative by NRC, Agreement States, and Industry................................................ C-1

List of Figures

Figure 1: Incremental Net Costs for Alternative 2 (7-Percent D iscount Rate)............................ 28 Figure 2: Alternative 2 Cost Drivers (7-Percent Discount Rate)................................................ 29

List of Tables

Table ES-1: Summary Table of Alternatives and Benefits (Costs)........................................... xiv Table 1: Advantages and Disadvantages of Alternative 2......................................................... 15 Table 2: Advantages and Disadvantages of Alternative 3......................................................... 16 Table 3: Advantages and Disadvantages of Alternative 4......................................................... 17 Table 4: Advantages and Disadvantages of Alternative 5......................................................... 18 Table 5: Alternatives and Benefits (Costs)................................................................................. 25

v

Abbreviations and Acronyms

ACMUI Advisory Committee on the Medical Uses of Isotopes

ADAMS Agencywide Documents Access and Management System

AEA Atomic Energy Act of 1954, as amended

Bq becquerel

CFR Code of Federal Regulations

CRCPD Conference of Radiation Control Program Directors, Inc.

DFA decommissioning financial assurance

DFP decommissioning funding plan

EPAct Energy Policy Act of 2005

FR Federal Register

Ga gallium

Ge germanium

ICRP International Commission on Radiological Protection

µCi microcurie

mCi millicurie

NARM naturally occurring and accelerator-produced radioactive m aterial

NPV net present value

NRC U.S. Nuclear Regulatory Commission

OAS Organization of Agreement States

PERT program evaluation and review technique

PRM petition for rulemaking

Pu plutonium

SECY Office of the Secretary of the Commission

SRM staff requirements memorandum

vii SSR Suggested State Regulations for Control of Radiation

U uranium

WBL Web-Based Licensing

viii Definition of Terms (as Used in this Document)

Applicant Any person, including a current licensee, who submits an applic ation for a license or license amendment to the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State for the use of byproduct material.

Decommission To remove a facility or site safely from service and reduce res idual radioactivity to a level that permits (1) release of the property for unrestricted use and te rmination of the license or (2) release of the property under restricted conditions and ter mination of the license (see Title 10 of the Code of Federal Regulations (10 CFR) 30.4, Definitions).

Decommissioning Funding Plan A document that contains a site-specific cost estimate for decommissioning, describes the method for assuring funds for decommissioning, describes the means for adjusting both the cost estimate and funding level over the life of the facility, and contains the certification of financial assurance and the signed originals of the financial instruments provided as financial assurance (see 10 CFR 30.35(e)).

Person Any individual, corporation, partnership, firm, association, tr ust, estate, public or private institution, group, Government agency other than the Commission or the U.S. Department of Energy, except that the Department shall be considered a person within the meaning of the regulations in this part to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission pursuant to Section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), any State or any po litical subdivision of or any political entity within a State, any foreign government or nati on or any political subdivision of any such government or nation, or other entity; and any legal succe ssor, representative, agent, or agency of the foregoing (see 10 CFR 30.4).

ix

Units Conversion Table

Multiply By ToObtain

English/Metric Equivalents

millicurie (mCi) 3.7x10 7 becquerel (Bq)

microcurie(µCi) 3.7x10 4 becquerel (Bq)

Metric/English Equivalents

becquerel (Bq) 2.7x10 -8 millicurie (mCi)

becquerel (Bq) 2.7x10 -5 microcurie (µCi)

xi

Executive Summary

The U.S. Nuclear Regulatory Commission (NRC) is considering rev ising the table in Appendix B, Quantities of Licensed Material Requiring Labeling, to Title 10 of the Code of Federal Regulations (10 CFR) Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material. The rulemaking would base the NRCs decom missioning funding requirements for radioactive material on the relative risk to p ublic health and safety from different radioisotopes, including naturally occurring and acce lerator-produced radioactive material (NARM). The NRC is taking this action in response to a petition for rulemaking (PRM) submitted by the Organization of Agreement States (OAS) on Apri l 14, 2017 (PRM-30-66, Request of the Organization of Agreement States for the NRC to Amend Appendix B, Quantities of Licensed Material Requiring Labeling, Supersede s ML17123A233 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML 17173A063)). In its petition, the OAS requested that the NRC provide specific posse ssion values for NARM radionuclides not currently listed in Appendix B to 10 CFR Part 30, so that licensees using these radionuclides would not have to apply the default values to cal culate decommissioning funding requirements or submit an exemption request. Licensees use App endix B in conjunction with 10 CFR 30.35, Financial assurance and recordkeeping for decomm issioning, and 10 CFR 70.25, Financial assurance and recordkeeping for decomm issioning, to determine the amount of decommissioning financial assurance (DFA) that is nee ded or whether a decommissioning funding plan is required. If the appendix does not include a particular radionuclide, licensees must use default values that may result in licensees needing more DFA than is warranted based on the risk to public health and safety.

The Commission approved initiation of this rulemaking in the st aff requirements memorandum SRM-SECY-19-0125, Staff RequirementsSECY-19-0125Petition for Rulemaking and Rulemaking Plan on Decommissioning Financial Assurance Requirem ents for Sealed and Unsealed Radioactive Material (PRM-30-66; NRC-2017-0159), date d October 13, 2020 (ADAMS Accession No. ML20287A248). The next step in the NRCs rulemaking process is the development of a regulatory basis that serves as a precursor to the proposed rule. This regulatory basis document summarizes the current regulatory fra mework, describes the regulatory issues, and evaluates alternatives for revising Appe ndix B. The regulatory basis also includes cost estimates for the NRC, Agreement States, and indu stry (i.e., licensees) for each alternative.

The NRC staff is recommending that the agency conduct a rulemaking as described in Alternative 2 of this regulatory basis. Under Alternative 2, the NRC would update Appendix B to 10 CFR Part 30 using the list of radionuclides and possession values from Appendix C, Quantities of Licensed Material Requiring Labeling, to 10 CFR Part 20, Standards for Protection Against Radiation. Additionally, the NRC would revise Appendix B to 10 CFR Part 30 to clarify that only radioactive materials with half-lives greater than 120 days are subject to DFA. Finally, the NRC would change the title of Appendix B to reflect its use in determining DFA requirements.

Alternative 2 would provide the fastest regulatory relief to stakeholders that have requested rulemaking and would offer an expeditious solution to the DFA concerns for licensees that currently use or plan to use the unlisted NARM radionuclides, especially in the diagnosis and treatment of diseases. For example, the currently unlisted gallium-68 (Ga-68) radionuclide is vitally important in the early detection and treatment of liver and pancreatic cancers; these types of cancers are hard to diagnose and metastasize quickly through the body. In addition, this

xiii radioactive material provides an effective dose to patients that is significantly lower than that from other radiopharmaceuticals. Thus, at this stage, the staff holds that the qualitative benefits from conducting a rulemaking under Alternative 2 would justify the potential cost impacts to licensees, Agreement States, and the NRC. Alternative 2 would result in projected costs totaling $6.5 million using a 7-percent discount factor and an averted cost of $15 million using the least costly alternative that accomplishes the Commissions directions. Table ES-1 provides the different alternatives with their respective costs. The staff will prepare a regulatory analysis of the qualitative and quantitative costs and benefits that considers public comments received on this regulatory basis for the proposed rule, consistent with NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission.

Table ES-1: Summary Table of Alternatives and Benefits (Costs)

DESCRIPTION Net Benefits (Costs) in 2021 Dollars Undiscounted 7% NPV 3% NPV Alternative 1Status Quo (No Action $0 $0 $0 Taken)

Alternative 2Update the List of Radionuclides and the Values i n the Table in Appendix B to 10 CFR Part 30 (NRC selected)

NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 2 NRC ($170,000) ($130,000) ($151,000)

Alternative 2 NRC Averted Cost $2,115,880 $2,075,601 $2,096,936 Alternative 2 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 2 Industry Averted Cost $15,146,546 $13,962,315 $14,589,590 Alternative 2 Agreement States ($2,710,000) ($2,049,000) ($2,398,000)

Alternative 2 Agreement States Averted $15,775,884 $15,115,132 $15,464,247 Cost Alternative 2 Total Net Benefits (Cost) $24,645,904 $24,696,030 $24,668,716

Alternative 3Partially Update A ppendix B to 10 CFR Part 30 (Add unlisted NARM radionuclides and other radionuclides not currently listed to the existing table in Appendix B to 10 CFR Part 30)

NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 3 NRC ($170,000) ($130,000) ($152,000)

Alternative 3 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 3 Agreement States ($2,710,000) ($2,049,000) ($2,398,000)

Alternative 3 Total Net Benefits (Cost) ($8,392,000) ($6,457,000) ($7,482,000)

Alternative 4Develop a New Pr ocess for Assessing Decommissioning Funding Costs NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 4 NRC ($222,000) ($169,000) ($197,000)

Alternative 4 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 4 Agreement States ($2,984,000) ($2,249,000) ($2,637,000)

Alternative 4 Total Net Benefits (Cost) ($8,718,000) ($6,697,000) ($7,767,000)

xiv Alternative 5Update Appendix B to 10 CFR Part 30 and Develop a New Process for Assessing Decommissioning Funding Costs (Combines Alternative 2 and Alternative 4 - Two rulemakings)

NRC Implementation ($1,088,000) ($861,000) ($979,000)

Alternative 5 NRC ($392,000) ($259,000) ($326,000)

Alternative 5 Industry ($9,989,000) ($6,717,000) ($8,380,000)

Alternative 5 Agreement States ($5,694,000) ($3,765,000) ($4,741,000)

Alternative 5 Total Net Benefits (Cost) ($17,163,000) ($11,601,000) ($14,427,000)

• Values rounded to the nearest thousand. There may be differences among the tables due to rounding.

• Values in parenthesis, e.g., () denote a cost of negative value.

xv

1. Introduction

The U.S. Nuclear Regulatory Commission (NRC) established regula tions in 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 70, Domestic Licensing of Special Nuclear Material, that set forth the technical and financial criteria for decommission ing licensed nuclear materials facilities that use sealed and unsealed radioactive materials. In 10 CFR 30.4, Definitions, the NRC defines decommissioning as the process whereby a facility o r site is safely removed from service and residual radioactivity is reduced to a level that p ermits (1) release of the property for unrestricted use and termination of the license or (2) release of the property under restricted conditions and termination of the license. Decommissioning act ivities are initiated when any one of the following events occurs:

• The license expires.

• The licensee has decided to permanently cease operations at th e entire site or in any separate building or outdoor area that contains residual radioa ctivity, such that the building or outdoor area is unsuitable for release in accordance with NR C requirements.

• No principal activities have been conducted at the site for a period of 24 months.

• No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity, such that the building or outdoor area is unsuitable for release in accordance with NRC r equirements.

Financial assurance is a guarantee or other financial arrangeme nt provided by a licensee to ensure that funds are available for decommissioning when needed (see NUREG-1757, Volume 3, Revision 1, Consolidated Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness, Final Report, issued February 2012). Thus, the NRC uses decommissioning financial assurance (DFA) requirements to ensure that the decommissioning of licensed nuclear facilities is performed in a safe and timely manner, and to ensure that adequ ate funds are available to complete decommissioning. The NRCs overall objective with res pect to decommissioning is to protect public health and safety and the environment from the u se of radioactive materials under its regulatory authority.

To determine the amount of DFA for a given radionuclide with a half-life greater than 120 days, one must multiply the possession value for the radionuclide in 10 CFR Part 30, Appendix B, Quantities of Licensed Material Requiring Labeling, by 1x10 5 for unsealed radioactive material in 10 CFR 30.35, Financial assurance and recordkeeping for decomm issioning, and 10 CFR 70.25, Financial assurance and recordkeeping for decommissioning. I n addition, 10 CFR 30.35 provides that for sealed sources, the possession value in Appen dix B is multiplied by 1x1012. The regulations in 10 CFR 30.35(a) and 10 CFR 70.25(a) require a li cense-specific decommissioning funding plan (DFP) to possess a quantity of radionuclides great er than that shown in the corresponding tables in 10 CFR 30.35(d) and 10 CFR 70.25(d). T hese tables require specific amounts of funding for specified ranges in the quantity of the radionuclide possessed. The funding amounts and quantity ranges in both tables are identical, but 1 0 CFR 30.35 applies to byproduct material while 10 CFR 70.25 applies to special nuclear material.

1 The NRC originally established the values in Appendix B to make the possession thresholds match for both licensing and labeling. The labeling values were init ially issued in 1963 in Appendix C, Quantities of Licensed Material Requiring Labeling, to 10 CFR Part 20, Standards for Protection Against Radiation, and were redesignated in 1993 for decommiss ioning funding purposes as Appendix B to 10 CFR Part 30 (58 FR 67659, December 22, 1993). Appendix B also includes possession values for radionuclides not specifically listed, wh ich are known as default possession values. The default values are set to equal the lowest values of the listed isotopes:

0.01 microcurie (Ci) for alpha emitters like radium-226, and 0.1 Ci for the most restricted nonalpha-emitting isotopes (e.g., iodine-129, strontium-90 or l ead-210). As a result, licensees using unlisted radionuclides may be subject to more restrictive DFA requirements regardless of the risk-significance of those radionuclides to public health and s afety.

On April 14, 2017, the Organization of Agreement States (OAS) s ubmitted a petition for rulemaking (PRM) to the NRC (PRM-30-66, Request of the Organization of Ag reement States for the NRC to Amend Appendix B, Quantities of Licensed Material Requiring La beling, Supersedes ML17123A233, ADAMS Accession No. ML17173A063)). In its petit ion, the OAS requested that the NRC provide specific possession values for naturally occurr ing and accelerator-produced radioactive material (NARM) radionuclides not currently listed in Appendix B to 10 CFR Part 30 so that licensees using these isotopes would not have to apply the appendixs default values to calculate decommissioning funding requirements.

In SECY-19-0125, Petition for Rulemaking and Rulemaking Plan o n Decommissioning Financial Assurance Requirements for Sealed and Unsealed Radioactive Mate rial (PRM-30-66; NRC-2017-0159), dated December 17, 2019 (ADAMS Accession No. M L18292A479), the staff sought Commission approval to initiate rulemaking in response t o the OAS petition. The Commission approved the initiation of rulemaking in Staff Requi rements Memorandum (SRM)-SECY-19-0125, Staff RequirementsSECY-19-0125Petition f or Rulemaking and Rulemaking Plan on Decommissioning Financial Assurance Requirem ents for Sealed and Unsealed Radioactive Material (PRM-30-66; NRC-2017-0159), date d October 13, 2020 (ADAMS Accession No. ML20287A248).

Consistent with the Commissions direction in SRM-SECY-19-0125 and the NRCs rulemaking process, the staff has prepared this regulatory basis, which do es the following:

• provides background information on policies, laws, and regulat ions relative to the issue

• explains how a change in the regulations could resolve the iss ue

• identifies different approaches that could address the regulat ory issue and evaluates the cost and benefits of rulemaking and the alternatives

• provides the scientific, policy, legal, and technical informat ion used to support the evaluation

• explains limitations on the scope and quality of the regulator y basis, such as known uncertainties in the data or methods of analysis

• discusses stakeholder interactions in developing the technical portion of the regulatory basis and stakeholder views, to the extent known

2 The purpose of this rulemaking is to (1) improve the regulatory framework for NARM by amending Appendix B to 10 CFR Part 30 to align with the NRCs regulatory authority under the Energy Policy Act of 2005 (EPAct) by adding these unlisted radionuclides, (2) risk-inform the NRCs decommissioning funding requirements by aligning the values in Appendix B with the NRCs radiation protection regulations in 10 CFR Part 20, (3) clarify that only radioactive materials with half-lives greater than 120 days are subject to DFA, and (4) cl arify the purpose of Appendix B by changing its title. Specific to item 3, the NRC is proposing t o update Appendix B to 10 CFR Part 30 using the list of radionuclides and possession values i n Appendix C to 10 CFR Part 20.

2. Background and Existing Regulatory Framework

This section briefly discusses the background and existing regu latory framework relative to the DFA requirements for sealed and unsealed radioactive material. Specifically, this section discusses the statutes, regulations, and Commission policies th at are relevant to development of this regulatory basis related to DFA requirements.

2.1 Relevant NARM Statutes and Regulations

2.1.1 The Energy Policy Act of 2005

On August 8, 2005, the President signed into law the Energy Pol icy Act of 2005 (EPAct).

Section 651(e) of the EPAct expanded the definition of byproduc t material given in Section 11e of the Atomic Energy Act of 1954 (AEA). The expanded definition p laced additional byproduct material under the NRCs jurisdiction and required the Commissi on to provide a regulatory framework for licensing and regulating this additional byproduc t material. Specifically, Section 651(e) of the EPAct expanded the definition of byproduc t material to include any discrete source of radium-226 that is produced for a commercial, medical, or research activity, and any naturally radioactive material other than source material, that the Commission in consultation with the Administrator of the Environmental Protection Agency, the S ecretary of the Department of Energy and the Secretary of the Department of Homeland Security and the head of any other appropriate Federal agencies, determines would pose a threat si milar to the threat posed by radium-226 to the public health and safety or common defense an d security; and is extracted or converted after extraction before, on, or after August 8, 2005 and accelerator-produced radioactive material. This new category of byproduct material is referred to as NARM.

2.1.2 The NARM Rule

On October 1, 2007, the NRC published in the Federal Register the Final Rule: Requirements for Expanded Definition of Byproduct Material (72 FR 55863), which is commonly referred to as the NARM Rule. The purpose of the final rule was to implement the authority that the NRC obtained over NARM through the EPAct. Before enactment of that law, the NRC did not regulate NARM.

However, the NRCs definition of occupational dose in 10 CFR Pa rt 20 did include dose contributions from both licensed and nonlicensed radioactive ma terial such as NARM. In addition, the NRC required licensees to consider nondiscrete sources, inc luding radium, during decommissioning activities at sites such as rare-earth processi ng facilities that were contaminated with source material.

Before the EPAct, Agreement States and some non-Agreement State s had regulatory programs for NARM. The law mandated that the NRC use model State standa rds to the maximum extent

3 practicable. Thus, the NRC consi dered the SSRs published by Conference of Radiation Control Program Directors, Inc., (CRCPD) 1 as the model State standard in developing the rule and ensured that all of the NARM radionuclide-specific values were listed in Appendix B to 10 CFR Part 20, Annual Limits on Intake (ALIs) and Derived Air Concen trations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrati ons for Release to Sewerage, and Appendix C to 10 CFR Part 20. However, the NRC did not ame nd Appendix B to 10 CFR Part 30, which is used in DFA determinations, to include NARM radion uclides.

2.2 NRC Decommissioning Financial Assurance Regulations

2.2.1 Final Rule of 1988

On June 27, 1988, the NRC published in the Federal Register its first comprehensive set of regulations addressing the decommissioning of nuclear facilitie s, Final Rule: General Requirements for Decommissioning Nuclear Facilities (53 FR 240 18). These regulations were the result of a thorough review over multiple years of issues assoc iated with the decommissioning of nuclear facilities as described in numerous SECY papers and SRM s, contractor reports, Federal Register notices, a generic environmental impact statement, public meet ings, and comment analysis.1F2 The purpose of the rule was to assure that, at the time opera tions were terminated (including premature closure of nuclear facilities), adequate f unds would be available to complete decommissioning in a safe and timely manner. The regulations a ddressed decommissioning planning needs, timing, funding methods, and environmental revi ew requirements. With regard to DFA for sealed and unsealed radioactive material, the new 10 CF R 30.35 required licensees that possessed and used byproduct material with a half-life greater than 120 days to use the quantities in Appendix C to 10 CFR Part 20 2F3 to determine whether a DFP was needed. The regulation in 10 CFR 70.25 required licensees that possessed and used unseale d special nuclear material to refer to the quantities in Appendix C to determine whether a DF P was needed.

1 The CRCPD is a nonprofit, nongovernmental professional organization dedicated to radiation protection. The CRCPDs mission is to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education. As part of this mission, CRCPD compiles the SSRCRs in a dynamic document that is revised and updated on an ongoing basis. The SSRCRs consist of a number of parts that relate to various aspects of radiation regulation.

2 These documents include (1) January 10, 1978, SECY-78-13, Recommendations on Course of Action for Establishing Nuclear Facility Decommissioning Requirements (ADAMS Accession No. ML22063A141);

(2) January 31, 1978, SECY-78-13A, Supplemental Information to SECY-78-13 Recommendations on Course of Action for Establishing Nuclear Facility Decommissioning Requirements, (ADAMS Accession No. ML21252A614); (3) February 17, 1978, SRM-78-13, Recommendations on Course of Action for Establishing Nuclear Facility Decommissioning Requirements, (ADAMS Accession No. ML22063A473);

(4) March 13, 1978, Advance Notice of Rulemaking for Decommissioning Criteria for Nuclear Facilities (43 FR 10370); (5) June 22, 1979, Response to and Partial Denial of Petition for Rulemaking Filed by the Public Interest Research Group, et al. (Docket No. PRM-50-22), (44 FR 36523) which requested the Commission initiate rulemaking to promulgate regulations for nuclear power plant decommissioning; (6)

May 5, 1980, Proposed Rule: Decommissioning of Nuclear Facilities Regulation (10 CFR Parts 30, 40, 50, and

70) (45 FR 37011); (7) February 10,1981, Decommissioning Criteria for Nuclear Facilities: Notice of Availability of Draft Generic Environment Impact Statement (10 CFR Parts 30, 40, 50, and 70) (46 FR 11666);

and (8) February 11, 1985, Proposed Rule: Decommissioning Criteria for Nuclear Facilities (10 CFR Parts 30, 40, 50, 51, 70, and 72) (50 FR 5600).

3 The NRC redesigned Appendix C to 10 CFR Part 20 as Appendix B to 10 CFR Part 30 as part of the December 22, 1993, amendment of the NRCs regulation, which is discussed in Section 2.2.2.1 of this regulatory basis.

4 2.2.2 Amendments of Interest

The NRCs decommissioning requirements relative to sealed and u nsealed radioactive material have undergone at least 12 amendments since their initial adopt ion in 1988. The discussion in this regulatory basis focuses on those revisions that pertain to the current rulemaking.

2.2.2.1 Amendments to 10 CFR Part 20

On May 21, 1991, the NRC published the Final Rule: Standards for Protection Against Radiation (56 FR 23360). The purpose of the rule was to modify the NRCs primary radiation protection regulations in 10 CFR Part 20 to reflect scientific development s since their issuance in 1957 (22 FR 548; January 29, 1957) by the Atomic Energy Commission ( the NRCs predecessor agency) and subsequent amendments in the 1960s and 1970s (25 FR 8595, September 7, 1960; 25 FR 10914, November 17, 1960; and 35 FR 6425, April 22, 1970). These earlier versions of 10 CFR Part 20 were based upon the recommendations of the Natio nal Committee on Radiation Protection and Measurements in National Bureau of Standards Han dbook 52, Maximum Permissible Amounts of Radioisotopes in the Human Body and Maxi mum Permissible Concentrations in Air and Water, dated March 20, 1953, and Han dbook 59, Permissible Dose from External Sources of Ionizing Radiation, dated January 8, 1957, that were incorporated into International Commission on Radiological Protection (ICRP) Publ ication 2, Report of Committee II on Permissible Dose for Internal Radiation (1959), issued 1960. After years of research into the biological effects of ionizing radiation, it was determined tha t some of the early concepts of radiation protection created over-conservativeness in the regul ation of radioactive material. The 1991 amendments to 10 CFR Part 20 adopted the updated and more risk-informed basic tenets of radiation protection in ICRP Publication 26, Recommendations o f the International Commission on Radiological Protection, adopted January 17, 1977, and ICRP Pu blication 30, Limits for Intakes of Radionuclides by Workers, issued 1979-1988. 3F4

The 1991 amendments revised the values in Appendix C to 10 CFR Part 20. The revised appendix lists µCi quantities for 757 radionuclides. However, with regard to DFA requirements for sealed and unsealed radioactive materials, the final rule amend ed 10 CFR 30.35 and 10 CFR 70.25 as follows:

paragraph (a) is amended by revising the references to appen dix C to 10 CFR part 20 and appendix C to read appendix C to §§ 20.1 -20.601 of 10 CFR part 20; paragraph (d) is amended by revising the three references to appendix C of the part 20 to read appendix C to §§ 20.1-20.6 01 of 10 CFR part 20; and by adding a note at the end of the section to read as follows:

4 ICRP Publication 30 was published in four parts and several supplements. These publications are: (1) ICRP, 1979. Limits for Intakes of Radionuclides by Workers. ICRP Publication 30 (Part 1). Ann. ICRP 2 (3-4);

(2) ICRP, 1979. Limits for Intakes of Radionuclides by Workers. ICRP Publication 30 (Supplement to Part 1).

Ann. ICRP 3 (1-4); (2) ICRP, 1980. Limits for Intakes of Radionuclides by Workers. ICRP Publication 30 (Part 2). Ann. ICRP 4 (3-4); (3) ICRP, 1981. Limits for Intakes of Radionuclides by Workers. ICRP Publication 30 (Part 3). Ann. ICRP 6 (2-3); (4) ICRP, 1982. Limits for Intakes of Radionuclides by Workers.

ICRP Publication 30 (Supplement B to Part 3). Ann. ICRP 8 (1-3); (5) ICRP, 1982. Limits for Intakes of Radionuclides by Workers. ICRP Publication 30 (Index). Ann. ICRP 8 (4); and (6) ICRP, 1988. Limits for Intakes of Radionuclides by Workers: An Addendum. ICRP Publication 30 (Part 4). Ann. ICRP 19 (4). These publications are referenced collectively in the condensed reference formats as ICRP Publication 30 (1988) in this document.

5 Note: Appendix C of §§ 20.1-20.601 of 10 CFR part 20 applies for the purpose of estimating decommissioning costs regardless of whether the l icensee adopts 10 CFR 20.1001-20.2401 or continues to use 10 CFR 20.1-20.601.

As a result, the values in Appendix C to 10 CFR 20.1-20.601 con tinued to be based upon biokinetic models described in ICRP Publication 2 (1959). The NRCs proposed, Standards for Protection Against Radiation (50 FR 51992, December 20, 1985, and 51 FR 1092, January 9, 1986) indicated in the statements of consideration t hat the NRC determined that it was not necessary to conform the values in Appendix C to 10 CFR 20. 1-20.601 that were used for decommissioning cost determinations with the revised values in Appendix C to 10 CFR 20.1001-20.2401.

2.2.2.2 Origin and Basis of Appendix B to 10 CFR Part 30

On December 22, 1993, the NRC published a final rule, Standard s for Protection Against Radiation; Removal of Expired Material. The rule made a numbe r of minor conforming amendments to the NRCs standards for protection against radiat ion that were published on May 21, 1991 (56 FR 23360). It removed the text of the superse ded standards and conformed references in the new 10 CFR Part 20. With regard to DFA, the NRC redesignated Appendix C to 10 CFR 20.1-20.601 as Appendix B to 10 CFR Part 30. In turn, i t revised 10 CFR 30.35 and 10 CFR 70.25 to eliminate references to Appendix C to 10 CFR P art 20 and to insert references to Appendix B to 10 CFR Part 30.

As a result, the Appendix B to Part 30 values continued to be b ased upon ICRP Publication 2. The NRC decided not to conform the Appendix B values to ICRP Public ations 26 and 30 during the 1991 revision of 10 CFR Part 20. The NRC had determined that i ts experience with the values in Appendix C to 10 CFR Part 20 over 30 years had shown that the v alues were generally adequate to determine the level of funding assurance required for decomm issioning and, therefore, retained them.

2.2.2.3 Origin and Basis of the 120-Day Half-Life Criterion

In the February 11, 1985, in its proposed rule, Decommissionin g Criteria for Nuclear Facilities (50 FR 5600), the NRC indicated that funding plans would be req uired for licensees authorized to use sealed and unsealed byproduct material with a half-life gre ater than 120 days. Commenters on the proposed rule supported this criterion. For example, Ma llinckrodt, Inc., which is one of the largest manufacturers of radiopharmaceuticals in the United Sta tes, referred to this criterion as a prudent decision that would provide safe and timely decommis sioning of byproduct material facilities. The Agreement State of Rhode Island noted that m edical licensees would be largely unaffected [by the addition of DFP requirements] because they g enerally do not utilize unsealed byproduct material containing radionuclides with a half-life gr eater than 120 days (see NUREG-1221, Summary, Analysis, and Response to Public Comments on Proposed Amendments to 10 CFR Parts 30, 40, 50, 51, 70, and 72, Decommis sioning Criteria for Nuclear Facilities, issued June 1988 (ADAMS Accession No. ML18073A149) ).

6 The statements of consideration for the proposed rule did not p rovide a specific rationale for the 120-day threshold. Rather, the section entitled Mechanisms fo r Requiring Financial Assurance, stated, The amounts (of financial assurance) for materials lic ensees were chosen based primarily on data in NUREG/CR-1754 and on licensing experience. The dat a in NUREG/CR-1754, Technology, Safety and Costs of Decommissioning Reference Non-Fuel-Cycle Nuclear Facilities, issued February 1981(ADAMS Accession No. ML20008E869), indicate d that if a licensee is limited to the use of very short-lived radionuclides, then its faciliti es do not require a major decommissioning effort.

The greater than 120-day half-life criterion is consistent with the agencys regulation of low-level waste disposal through onsite decay-in-storage. The NRC previo usly had two decay-in-storage license conditions: one was for medical licensees and the othe r for nonmedical licensees. Both license conditions authorized decay-in-storage for waste contai ning radioactive material with half-lives less than or equal to 120 days, provided that the ra dioactive material was held for a minimum of 10 half-lives and additional conditions were met. 4F5

Thus, the statements of consideration for the proposed rule, th e data in NUREG/CR-1754, and the NRCs licensing experience with decay-in-storage support the 12 0-day half-life criterion for DFA for byproduct material. The data in NUREG/CR-1754 and the NRCs li censing experience indicate that (1) radioactive materials with very short half-lives do no t require a major decommissioning effort, and (2) radioactive materials with half-lives less than or equal to 120 days will completely decay in a few years.

2.2.2.4 10 CFR Part 70 Licensees

The NRC describes financial assurance for licensees possessing special nuclear material in 10 CFR 70.25. Special nuclear material generally means plutoni um, uranium(U)-233, uranium enriched in the isotope 233 or in the isotope 235, or any other material the Commission determines to be special nuclear material, but it does not include source material. A table of amounts of financial assurance for decommissioning by quantity of material appears in 10 CFR 70.25(d). This table refers to applicable quantities of appendix B to part 30 but does not limit consideration to radionuclides of special nuclear material with a half-life grea ter than 120 days. The only special nuclear material radionuclides contained in the current Appendi x B to 10 CFR Part 30 are plutonium (Pu)-239, uranium (natural), uranium-233, and uranium-234--uranium-235.

2.3 The Existing Regulatory Framework

Either the NRC or an Agreement State regulates the Nations use of radioactive materials, including by applying the requirements for DFA. The following sections describe these regulatory processes for determining the need for a DFP, the basis for est ablishing the decommissioning funding level, and the role of the Agreement States in the proc ess.

5 See the NRC letter dated June 4, 1981, to all of its medical and academic licensees on decay-in-storage before disposal (ADAMS Accession No. ML20136E300), and Appendix E to NUREG-1556, Volume 20, Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures, Final Report, issued December 2000 (ADAMS Accession No. ML010250252). For additional information on NRCs decay-in-storage rulemakings, see the discussions at 10 CFR Part 35.92 in 51 FR 36951 and 67 FR 20299.

7 2.3.1 NRC Regulatory Program

As stated in Section 1, the NRCs regulations in 10 CFR 30.35 a nd Appendix B to 10 CFR Part 30 are used together to determine the amount of DFA required for u nsealed and sealed byproduct material. The regulations in 10 CFR 70.25 and Appendix B to 10 CFR Part 30 are used together to determine the amount of DFA required for unsealed special nucle ar material. As noted in 10 CFR 30.35(a)(1) and 10 CFR 70.25(a)(2), DFPs must be submitt ed when radionuclide concentrations exceed 1x10 5 times the applicable quantities listed in the table in Appendi x B to 10 CFR Part 30. Individuals with licenses authorizing the poss ession and use of sealed sources or plated foils at quantities 1x10 12 times the values in the table in Appendix B to 10 CFR Part 30 must also submit DFPs. The NRC gives additional details about these criteria in 10 CFR 30.35(d) and 10 CFR 70.25(d).

The table in Appendix B to 10 CFR Part 30 includes default poss ession values for radionuclides not specifically listed. The default possession values are equ al to the lowest values listed in Appendix B for specific alpha-emitting and gamma-and beta-emit ting radionuclides.

2.3.2 Agreement State Regulatory Program

Section 274 of the AEA authorizes the NRC to enter into agreeme nts with individual States, known as Agreement States, providing them the authority and responsib ility for administering a regulatory program for the safe use of radioactive materials within their borders. For the duration of such agreements, the Agreement States have the authority to regulate the materials covered by the agreement for the protection of public health and safety and th e environment from radiation hazards. The Agreement States are required to adopt regulation s in accordance with the compatibility category designation assigned to each NRC regulat ion, as discussed in NRC Management Directive 5.9, Adequacy and Compatibility of Progra m Elements for Agreement State Programs, dated April 26, 2018 (ADAMS Accession No. ML18 081A070). Appendix B to 10 CFR Part 30 is designated as Compatibility Category B, which means that the Agreement States will be required to adopt requirements that are essentia lly identical to those in the NRCs regulations, including the requirements for DFA for sealed and unsealed radioactive material.

Other provisions, 10 CFR 30.35(a), (b), (e), and (g), relating to decommissioning funding are classified and Category Health & Safety (H&S). Category H&S ar e not required for purposes of compatibility. However, the Stat e must adopt program elements in this category, that embody the basic H&S aspects of the NRCs program elements. These section s are not planned to be revised as a part of this rulemaking.

2.4 Requests for Revisions to the NRCs Regulations

2.4.1 NRC Advisory Committee on the Medical Uses of Isotopes

Many of the unlisted radionuclides are used in the diagnosis an d treatment of diseases. The unlisted radionuclides germanium (Ge)-68/gallium (Ga)-68 are of particular concern to those in the medical field. Radiopharmaceuticals labeled with Ga-68 have be en proven to be effective in the

8 early diagnosis and treatment of neuroendocrine tumors, includi ng cancers of the prostate, liver, and pancreas. These types of cancers are difficult to diagnose and can spread through the body quickly. As a result, Ge-68/Ga-68 generators 5F6 are vitally important in the early detection and treatment of these types of cancers. In addition to their enha nced diagnostic capabilities, Ga-68-labeled radiopharmaceuticals provide a lower effective do se to patients when compared to other radiopharmaceuticals. They also are less expensive and m ore accessible when compared to other diagnostic tools and therapies used in cancer treatment.

Because of the importance of Ge-68/Ga-68 generators in the diag nosis and treatment of liver and pancreatic cancers, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) issued the Germanium-68 (Ge-68) Decommissioning Funding Plan (DFP) Final Report, and addendum, dated August 12, 2015 (ADAMS Accession No. ML15231A047). In th e report, the ACMUI concluded that the restrictive aspects of a DFP for Ge-68/Ga-68 generators that arise from the current 10 CFR Part 30 regulations were preventing or deterring the use of promising Ga-68 diagnostic imaging agents for patients. The ACMUI also noted t hat patients treated with Ga-68 radiopharmaceuticals would receive nearly a five-fold reduction in effective dose when compared to other radiopharmaceuticals. Thus, the ACMUI recommended tha t the NRC address the DFP concerns relative to Ge-68/Ga-68 generators.

The NRC staff agreed with the ACMUI report that the DFP require ment could impede or limit patient access to the radiopharmaceuticals developed from Ge-68 /Ga-68 generators and that a DFP is not necessary to ensure the safe decommissioning of faci lities that use the generators. By memoranda dated July 29, 2016, (ADAMS Accession No. ML16082A415 ) and July 13, 2017 (ADAMS Accession No. ML17075A487), the NRC established a proces s for granting exemptions to the DFP requirements. The NRC staff issued guidance for the exemption that would relieve a licensee from the requirement for a DFP for the possession and use of Ge-68/Ga-68 radiopharmaceutical generators when certain conditions are met. The guidance allowed exemptions only from the DFP requirement, and only for licensee s using Ge-68/Ga-68 generators.

Specifically, the exemption guidance provided that licensees co uld possess up to 19 Ge 68/Ga 68 generators with $1.125 million in DFA. In addition, the exempt ion guidance provided that the licensees would maintain and submit for NRC review a legally bi nding agreement that ensured that the Ge-68/Ga-68 generators will be returned to the manufacturer or distributor at the end of use in order to qualify for the DFA certification option.

The NRC created this exemption process to provide a pathway unt il it could address the issue generically through rulemaking, as stated in the July 2016 memo randum. The rulemaking recommended in this regulatory basis document would provide a r egulatory solution.

2.4.2 Organization of Agreement States PetitionPRM-30-66

As mentioned above, in PRM-30-66, the OAS requested that the NR C provide specific possession values for NARM radionuclides that are not currently listed in Appendix B to 10 CFR Part 30 so that licensees using these isotopes, especially medical license es, would not have to apply the

6 A Ge-68/Ga-68 radiopharmaceutical generator is a device used to extract the positron-emitting isotope Ga-68 from a source of decaying Ge-68. The parent isotope Ge-68 has a half-life of 271 days, which serves as the basis for DFA because it has a half-life greater than the 120-day criterion, while the daughter isotope, Ga-68, has a half-life of only 68 minutes. Because of its short half-life, in-hospital generator production of Ga-68 is the optimal production method.

9 appendixs default values to calculate decommissioning funding requirements. The OAS asserted the following:

• Without possession values for the unlisted radionuclides, regu lators are forced to evaluate new products against the default criteria and apply overly burd ensome financial assurance obligations or evaluate case-by-case exemptions.

• Patient health and safety are being compromised due to delays in licensing important diagnostic and therapeutic products that use radionuclides not listed in the table in 10 CFR Part 30, Appendix B.

• These licensing obstacles could discourage development of new products, diminishing the possibility of new innovative and beneficial options in both me dical and industrial applications.

• Rather than issuing exemptions on a case-by-case basis, the mo re appropriate way to address the inconsistency in Appendix B is to amend it to add a ppropriate radionuclides and their corresponding activities.

On August 23, 2017, the NRC published a Federal Register notice of docketing (82 FR 39971) and requested comments on issues raised in the petition. The comme nt period ended on December 6, 2017, and the agency received 20 comment letters (A DAMS Package Accession No. ML18038A879). Fifteen commenters explicitly supported rule making, and one commenter requested a generic exception that only rulemaking can provide. No commenters opposed rulemaking, but one letter, while supporting a rulemaking for m edical licensees, indicated that rulemaking could result in exempting industrial uses from AEA r egulation under the guise of a medical purpose. Five commenters identified 10 radionuclides w hose uses have been adversely affected by not being listed in Appendix B to 10 CFR Part 30.

2.4.3 SECY-19-0125 and Associated SRM-SECY-19-0125

The NRC staff sought Commission approval to initiate rulemaking in response to the OAS petition.

The rulemaking would involve a revision to Appendix B to 10 CFR Part 30 and could involve a revision to 10 CFR 30.35 and 10 CFR 70.25. As discussed in SEC Y-19-0125, the rulemaking would do the following:

• Replace the listings and values in Appendix B to 10 CFR Part 3 0 with those of Appendix C to 10 CFR Part 20 for isotopes with a half-life greater than 12 0 days.

• Develop a new methodology for assessing DFA requirements and d eveloping site-specific DFPs based on decommissioning risk factors.

• Amend the title to the table in Appendix B to 10 CFR Part 30 t o reflect its current use for DFA as opposed to labeling.

• Remove all radionuclides with a half-life of 120 days or less from the table in Appendix B to 10 CFR Part 30 since these radionuclides are not considered whe n assessing DFA requirements and developing site-specific DFPs.

10

• Examine the merits of creating a new category for isotope gene rators that provides an engineered confinement greater than in unsealed form but less t han that of a sealed source.

In SRM-SECY-19-0125, the Commission approved the initiation of rulemaking in response to PRM-30-66 to provide specific possession values for radionuclid es that are not currently listed in Appendix B to 10 CFR Part 30 and the publication of the staffs proposed Federal Register notice announcing the determination on this petition. The NRC publish ed a Federal Register notice on November 27, 2020 (85 FR 75959), announcing that the agency wou ld consider the issues raised in PRM-30-66 through the NRCs rulemaking process.

2.4.4 Other Stakeholder Requests

The NRC held a public meeting on January 7, 2021, to gain stake holder input on the regulatory approaches for DFA requirements for sealed and unsealed radioac tive material (see ADAMS Package Accession No. ML21026A339).

At the public meeting, the NRC discussed regulatory issues rela ted to the current DFA requirements and specific radionuclides that are not listed in Appendix B to 10 CFR Part 30. The NRC specifically discussed the following:

• Potential rulemaking options for updating Appendix B to 10 CFR Part 30, including developing a new risk methodology for calculating new Appendix B values or updating the Appendix B values using the values currently listed in Appendix C to 10 CFR Part 20.

• An option to create a separate category within 10 CFR 30.35(d) for radiopharmaceutical generators, given the engineering confinement of generators.

In general, the meeting participants supported the rulemaking o ption, noting that updating Appendix B to 10 CFR Part 30 to include radionuclides not curre ntly listed would help with DFA funding by eliminating the need to use default values as is cur rently required. The participants noted that the NRC needs to address DFA funding for Ge-68/Ga-68 generators as soon as possible, given that current funding requirements for these rad ionuclides are excessive when compared to their relative risk to public health and safety bas ed on their engineering design.

Several commenters supported a separate category for Ge-68/Ga-6 8 generators within 10 CFR 30.35(d), with one commenter suggesting that the NRC eva luate conducting a direct final rule for these items. Commenters also noted that financial ass urance requirements related to lutetium-177m also need to be addressed soon, given the likelih ood that there will be an increase in its use upon approval of new medical treatments.

Participants did not express a strong preference for either of the potential rulemaking options but said that a faster update to Appendix B to 10 CFR Part 30 would be helpful. Several commenters noted that updating Appendix B with values from Appendix C to 1 0 CFR Part 20 would not help provide lower DFA funding overall because some values could dec rease while other values could increase; therefore, the overall amount of required funding may not change. In addition, one commenter noted that updating Appendix B with the values in App endix C to 10 CFR Part 20 would enable its facility to use more radionuclides in its rese arch without changing the decommissioning funding amounts, given the use of the unity ru le in 10 CFR 30.35(a).

11

3. Statement of Regulatory Concerns

This section examines the regulatory concerns that are to be ad dressed as a part of this rulemaking to provide specific possession values for NARM radio nuclides and other radionuclides that are not currently listed in Appendix B to 10 CFR Part 30 f or DFA requirements for sealed and unsealed byproduct material.

3.1 Unaligned Appendix B Values and Radionuclide Listings

The current values in Appendix B to 10 CFR Part 30 are not alig ned with the NRCs primary radiation protection regulations in 10 CFR Part 20. Appendix B is based upon the radiation principles from ICRP Publication 2 (1959), while the values in Appendix C to 10 CFR Part 20 are based upon the more risk-informed principles in ICRP recommenda tions (ICRP Publication 26) and methodologies (ICRP Publication 30).

In addition, the current listing of radionuclides in Appendix B to 10 CFR Part 30 is not well-aligned with the NRCs regulatory authority under the EPAct. The EPAct amended the definition of byproduct material to include NARM radionuclides and provided t he NRC authority over this new category of byproduct material. However, the NRC has not updat ed Appendix B to 10 CFR Part 30 to add NARM radionuclides and their possession v alues.

3.2 Applying the Generic Default Values in Appendix B to 10 CFR Part 30

The application of the generic default possession values in App endix B to 10 CFR Part 30 for the DFA determinations of unlisted NARM radionuclides is not warran ted based on risk to public health and safety. First, the types and quantities of byproduct mater ial originally found in Appendix B to 10 CFR Part 30 were not developed to determine decommissioning funding. Rather, the values were initially derived from exceptions to labeling requirements such that certain small quantities of byproduct material could be released into the sanitary sewerage or buried in soil for disposal (58 FR 67657, December 22, 1993). Second, the default values w ere based upon the radiation protection principles in ICRP Publication 2 (1959) that were no t risk-informed by research into the biological effects of ionizing radiation. Third, the default v alues are generic and do not reflect isotope-specific possession values and their associated radiolo gical, chemical, and physical properties. Fourth, the generic default values are set to equa l the most restrictive values of the nonrisk-assigned isotopes: 0.01 Ci for alpha emitters like ra dium-226, and 0.1 Ci for the most restrictive values of nonalpha-bearing isotopes (iodine-129, st rontium-90 or lead-210)

For example, for an unsealed nonalpha-emitting isotope, a licen see possessing more than 0.1 millicurie (mCi) but less than 1 mCi would be required unde r 10 CFR 30.35(d) to provide

$225,000 in DFA. To possess more than 1 mCi of the radionuclid e, a licensee would be required to provide $1,125,000 in DFA, and a DFP would be required to po ssess more than 10 mCi.

However, if the NRC revised Appendix B to 10 CFR Part 30 to ado pt the values in Appendix C to 10 CFR Part 20, the minimum possession threshold for DFA or a D FP would increase 100-fold for NARM isotopes Ge-68, gold-195, sodium-22, and cobalt-57. Thus, the application of these generic default possession values creates regulatory burdens by requiri ng licensees to provide decommissioning funding that is not risk-informed by the isotop e-specific possession values.

12 3.3 Processing Exemption Requests

As discussed above, the NRC currently has granted licensee-requ ested exemptions for medical licensees that use Ge-68/Ga-68 generators under certain conditi ons. These exemptions were approved in advance of pending rulemaking to generically resolv e the issue. By providing a regulatory solution through rulemaking, the NRC would create a more stable framework for use by regulators, applicants, and licensees.

If the NRC does not complete this rulemaking, then the Ge-68/Ga -68 exemption process would be retracted, and consideration of exemption requests would revert to case-by-case reviews. In addition, since many of these unlis ted radionuclides are used i n the medical field, if the NRC does not pursue this rulemaking, many users of these unlisted isotop es are likely to submit numerous requests for exemptions to the DFA requirements, especially if the half-lives of these unlisted radionuclides are 120 days or less. The time and cost impacts from processing numerous exemption requests from DFA requirements on a case-by-case basi s for the radionuclides with a half-life of 120 days or less would be very burdensome for the NRC and the Agreement States. In addition, to the extent that the agency frequently issues simil ar exemptions, the NRC could be viewed as not following its own regulations.

3.4 Reviewing Plans for Unlisted Radionuclides

Some licensees are choosing to submit DFPs under 10 CFR 30.35 i nstead of using the exemption process for Ge-68/Ga-68 generators. The DFP requirements in 10 CFR 30.35(e) were intended for major facilities possessing large quantities of radioactive material with half-lives greater than the 120-day criterion because they require a significant decomm issioning effort. The 10 CFR 30.35(e) requirements, however, were not intended for th e types and quantities of radioactive material typically used by medical licensees, becau se such licensees normally use radionuclides with short half-lives that do not pose a signific ant risk to public health and safety.

Although medical licensees possess smaller quantities of radioa ctive material, they may develop facility-specific decommissioning cost estimates under 10 CFR 3 0.35(e). Some licensees pursue this option if they can demonstrate through a DFP that a lower amount of financial assurance is needed as compared to that required using the default possessio n values in Appendix B to 10 CFR Part 30. In addition, some licensees may find the submi ssion of a DFP more efficient and effective than the exemption submission and approval process.

The review and approval of DFA under 10 CFR 30.35(e) is resourc e intensive for both the licensee and the regulatory agency. The DFPs must contain, among other things, a detailed cost estimate for an independent contractor to perform decommissioning activi ties so that the site meets the requirements for unrestricted use and a certification that fina ncial assurance in the amount of the cost estimate has been provided. The licensee must resubmit th e DFP every 3 years with adjustments as necessary to account for changes in costs and th e extent of contamination. Even if a medical licensee possesses only one unlisted NARM radionuclid e that requires a DFP, the plan must cover all radionuclides at the site, whether or not the ag gregated total quantity of these other radionuclides would have required a DFP. Thus, this creates an unwarranted regulatory burden because the level of detail in the DFP would be unnecessary bas ed upon the relative risk to public health and safety when only one well-defined device, such as a Ge-68/Ga-68 generator, is triggering the DFP requirements.

13 3.5 Revising 10 CFR 30.35 with a New Methodology and Category f or Generators

In SECY-19-0125, the NRC staff discussed possibly developing a new methodology for determining DFA and creating a separate category in 10 CFR 30.3 5 for radiopharmaceutical generators. Five commenters on the OAS petition commented that Ge-68/Ga-68 generators should have a separate category within 10 CFR 30.35, and the DF A funding amounts should be lower than those currently required. Additionally, several sta keholders at a public meeting on this subject (see Section 7) also supported a separate category for these generators. However, the stakeholders at the public meeting supported updating Appendix B to 10 CFR Part 30 on a faster schedule than would be needed to develop a new decommissioning funding methodology and a separate category for generators.

3.6 Unaligned Appendix Title and Purpose

Appendix B to 10 CFR Part 30 is titled Quantities of Licensed Material Requiring Labeling. This title is not consistent with its intent and purpose. Appendix B is used solely for the purpose of calculating the required amounts of DFA. In addition, this tit le is the same as that of Appendix C to 10 CFR Part 20. Thus, this could potentially cause confusion a bout the appropriate appendix for labeling requirements and the appropriate appendix for decommis sioning requirements.

3.7 Unaligned Listing of Isotopes and Decommissioning Criteria

The current NRC regulations in 10 CFR 30.35 and 10 CFR 70.25 do cument the criteria for determining the amount of DFA required by licensees. DFA consi derations only apply for radionuclides with a half-life greater than 120 days. However, the table in Appendix B to 10 CFR Part 30, which is used for calculating DFA costs, includ es radionuclides with a half-life of 120 days or less. The disconnect between the criteria in 10 CF R 30.35 and the list of radionuclides in the table in Appendix B to 10 CFR Part 30 can lead to confusion about which radionuclides need to be considered when determining DFA requir ements.

4. Evaluation of Rulemaking Alternatives

In SRM-SECY-19-0125, the Commission directed the staff to initi ate rulemaking in response to the OAS petition requesting specific possession values for radionuc lides that are not currently listed in Appendix B to 10 CFR Part 30. The staff considered multiple al ternatives, including changes in the guidance as appropriate, to address the issues raised in the pe tition, while maintaining adequate protection of public health and safety. This section summarize s the five alternatives that the NRC considered.

4.1 Alternative 1The Status Quo

The status quo considers no changes to the current process for assessing a licensees DFA requirements. The status quo is considered to be the baseline from which the staff evaluated the four other alternatives.

14 4.2 Alternative 2Update the List of Radionuclides and the Values i n Appendix B to 10 CFR Part 30 Table (NRC Selected)

The NRC would revise the current table in Appendix B to 10 CFR Part 30 using the radionuclides and quantities from Appendix C to 10 CFR Part 20, including add itional radionuclides not currently named in Appendix B to 10 CFR Part 30. These include radionucl ides associated with industrial technologies and current and emerging medical uses. In additio n, the NRC would remove all radionuclides with a half-life of 120 days or less from the app endix since these radionuclides are not considered when developing DFA. Finally, the default value s would be set to equal the lowest values of the listed radionuclides: 0.001 Ci for alpha-emitti ng radionuclides like U-235, and 0.01 Ci for the most restricted nonalpha-emitting radionuclide s (e.g., iodine-129, strontium-90 or lead-210). By making these changes, licensees, the NRC staff, and the Agreement States would have an up-to-date table with more risk-informed values for use when assessing DFA. Appendix B to this document contains an updated version of the table.

Actions associated with this alternative do not affect the curr ent decommissioning funding costs outlined in 10 CFR 30.35(d) but do change the funding threshold s for some radionuclides. Based on the current cost criteria, changes to the table would decrea se costs associated with 18 radionuclides but would increase costs for others, especiall y alpha emitters. This approach to rulemaking does not provide flexibility for incorporating addit ional radionuclides in the future.

Additional rulemaking actions w ould be required if the NRC wish es to add radionuclides to the table in the future.

Table 1 lists the advantages and disadvantages considered by th e NRC for this alternative.

Table 1: Advantages and Disadvantages of Alternative 2

Advantages

• satisfies the petitioners request and Commission direction th rough a simple approach

• provides a more up-to-date and risk-informed table (ICRP 26/30 vs. ICRP 2)

• adds to the table specific radionuclides associated with indus trial technologies and current and emerging medical uses (e.g., Ge-68, sodium-22, sili con-32, titanium-44, cobalt-57, thulium-170, and lutetium-177 (metastable))

• removes over 130 radionuclides with a half-life <120 days

• decreases decommissioning costs for about 18 radionuclides by changing thresholds

• does not need lengthy analysis or contractor assistance

Disadvantages

• is not site specific or scenario specific

• does not address specific issues related to decommissioning co sts (10 CFR 30.35(d) or 10 CFR 70.25(d))

• increases decommissioning costs for a few radionuclides (prima rily alpha-emitting isotopes) by changing thresholds

• does not provide an option for adding new NARM radionuclides c reated in the future without additional rulemaking

Pursuing this alternative would result in a more up-to-date and risk-informed Appendix B to 10 CFR Part 30 for use in the development of DFA without requir ing significant time and

15 resources. For these reasons, the NRC recommends this alternative as the method to pursue for this rulemaking.

4.3 Alternative 3Partially Update Appendix B to 10 CFR Part 30 (Ad d Unlisted NARM Radionuclides and Other Radionuclides Not Currently Listed to t he Existing Table in Appendix B)

The NRC would add only the unliste d NARM radionuclides and other radionuclides listed in the table in Appendix C to 10 CFR Part 20 to the table in Appendix B, 10 CFR Part 30. The agency would not change the values for the radionuclides already liste d in Appendix B to 10 CFR Part 30.

The advantage of this alternative is that it would satisfy the request in the OAS petition to update Appendix B to 10 CFR Part 30 to include the unlisted NARM radio nuclides. However, this alternative would result in DFA requirements in the same table being based on multiple ICRP methodologies. The values in the current Appendix B to 10 CFR Part 30 are based upon the methodology of radiation protection in ICRP Publication 2 (1959 ) and do not address annual limits on intake or derived air concentrations. The values in the cur rent Appendix C to 10 CFR Part 20 are based on the methodologies in ICRP Publication 26 (1977) an d ICRP Publication 30. For this reason, the NRC is not recommending this alternative.

Table 2 lists the advantages and disadvantages considered by th e NRC for this alternative.

Table 2: Advantages and Disadvantages of Alternative 3

Advantages

• simple, straightforward approach that satisfies the petitioner s request

• values for the unlisted radionuclides would be added based upo n ICRP Publications 26 and 30, which would update and risk-inform the table

Disadvantages

• is not site specific or scenario specific

• does not provide an option for adding new radionuclides withou t further rulemaking

• does not address specific issues related to decommissioning co sts (10 CFR 30.35(d) or 10 CFR 70.25(d))

• would result in mixed radiation protection methodologies for a ssessing internal dose in the table because the current values in Appendix B to 10 CFR Pa rt 30 are based upon the dose methodology in ICRP Publication 2 and the values of th e NARM radionuclides to be added would be based upon ICRP Publications 26 and 30

• would require significantly greater NRC and Agreement State re sources to develop and implement the new requirements when compared to Alternative 2

• initial costs associated with establishing a DFP would likely be significantly greater than those required under Alternative 2

4.4 Alternative 4Develop a New Process for Assessing Decommiss ioning Funding Costs

As noted in SECY-19-0125, the NRC also intended to consider dev eloping a new methodology based on decommissioning risk factors. This alternative involv es eliminating the use of specific

16 tabulated values and establishing a new framework for determini ng decommissioning funding costs. Although this approach goes beyond the specific scope o f the OAS petition, it would provide licensees with a more up-to-date and risk-informed appr oach for developing DFA based on their individual, site-specific needs. This approach would be flexible enough to be modified as needed to address potential changes associated with a licensee s business interests.

The amount of time and resources required to develop and implem ent this alternative would be greater than the previous alternatives considered. This approa ch would require a minimum of approximately 15 months 6F7 to develop the technical basis as sociated with this approach a nd additional time to implement the new methodology and obtain con tractor support. Depending on how this approach is implemente d, there may be additional burde n on the NRC, particularly regional staff, who would have to review and approve each licen sees initia l DFP. The NRC would also have to perform periodic reviews to confirm that the approved funding plan is still adequate, as well as address any changes that the licensee may wish to implement. These additional burdens could also impact the Agreement States that implement similar programs for their licensees.

Initial costs associated with establishing a DFP would likely b e greater, as licensees would have to develop plans that incorporate the details associated with the site-specific criteria for determining decommissioning funding costs. For many licensees, however, th is approach could result in long-term cost savings, as costs for developing and maintaining this type of plan plus the costs for performing actual cleanup activities could be less than $113,00 0, the minimum value provided in 10 CFR 30.35(d) for sealed sources.

Table 3 lists the advantages and disadvantages considered by th e NRC for this alternative.

Table 3: Advantages and Disadvantages of Alternative 4

Advantages

• addresses decommissioning funding issues

• more accurate assessment of decommissioning costs (10 CFR 30.3 5(d) and 10 CFR 70.25(d))

• adaptable to different types of licensees/uses (e.g., generato rs, nondispersible)

• adjustable over time (e.g., licensees change function; decommi ssioning costs change)

• cost savings for some licensees

Disadvantages

• significant contractor costs

• possible increase in resources for some licensees associated w ith developing and maintaining a DFP

• at least 15 additional months would be needed to develop the t echnical basis

• would require significantly greater NRC and Agreement State re sources to develop and implement the new requirements when compared to Alternative 2

7 The staff based the estimate of 15 months on the time needed for a contract to be put in place, the contractor to conduct the technical analysis, and the staff to evaluate the contractors analysis.

17 This alternative would result in a more risk-informed approach for determining decommissioning funding costs and allow for added flexibility to address differ ences among licensees and changes over time. However, the NRC staff determined that developing a new approach would require significant time, effort, and resources. Based on internal dis cussions, comments received on the petition, and stakeholder input provided during the public meet ing, the NRC staff concluded that this approach also goes beyond the petitioners request of upda ting Appendix B to include unlisted NARM radionuclides not currently included in the table and woul d not provide the fast regulatory relief to licensees as requested. For these reasons, the NRC i s not recommending this alternative.

4.5 Alternative 5Update Appendix B to 10 CFR Part 30 and Develop a New Process for Assessing Decommissioning Funding Costs (Combines Alternative 2 and Alternative 4 - Two rulemakings)

This alternative considers combining Alternatives 2 and 4 into a multistep rulemaking process.

The NRC would update the values in Appendix B to 10 CFR Part 30 as outlined in Alternative 2, developing a more up-to-date and risk-informed table of values for use in assessing decommissioning funding costs. This addresses the concerns out lined in the petition and the direction provided by the Commission. The NRC then would inves tigate a more modern, risk-informed approach for developing and maintaining an up-to-date DFP, with contractor assistance and input from the public.

Table 4 lists the advantages and disadvantages considered by th e NRC for this alternative.

Table 4: Advantages and Disadvantages of Alternative 5

Advantages

• provides the same advantages identified for Alternatives 2 and 4

• addresses specific issues identified in SECY-19-0125 and issue s related to decommissioning costs

• provides quick resolution to the initial issues raised in the petition

• provides licensees with the flexibility to use either the tabl e or a site-specific approach

Disadvantages

• has the same disadvantages identified for Alternatives 2 and 4

• requires a longer timeframe to complete the final rule

Pursuing this alternative would result in a more up-to-date and risk-informed Appendix B to 10 CFR Part 30, while also developing a process for developing site-specific DFPs. However, this approach would require the approval of a second rulemaking, whi le stakeholders want a faster resolution to the request to provide specific radionuclide poss ession values. This alternative would also require two separate rulemakings and take longer to comple te. For these reasons, the NRC is not recommending this alternative.

5. Basis for Proposed Changes

This section explains the proposed changes to NRC regulations a nd discusses the technical rationale and assumptions used to support those changes. This section also discusses how the proposed changes could resolve the issues identified in Section 3 of this regulatory basis.

18 5.1 Proposed Changes

The recommended rulemaking alternative is to replace the entire Appendix B to 10 CFR Part 30 with the information from Appendix C to 10 CFR Part 20 except f or radionuclides with a half-life of less than or equal to 120 days. The NRC would change the title of Appendix B to align with its decommissioning purpose.

5.2 Benefits of the Rulemaking

5.2.1 A More Risk-Informed Regulation

A risk-informed approach to regulatory decisionmaking represent s a philosophy whereby risk insights are considered, together with other factors, to establ ish requirements that better focus licensee and regulatory attention on issues commensurate with t heir importance to public health and safety. This approach to regulation reduces unnecessary co nservatism in regulation. The rulemaking would advance the NRCs commitment to maintain up-to -date regulations by aligning the NRCs DFA requirements with more risk-informed possession v alues in Appendix B to 10 CFR Part 30. The Appendix B values are currently based on r adiation principles associated with ICRP Publication 2 (1959) that did not consider risk. The rulemaking would update the values in Appendix B using the values in Appendix C to 10 CFR Part 20. The Appendix C values reflect a more recent understanding of radionuclide biokinetics by incorp orating the methodologies in ICRP Publication 26 (1977) and ICRP Publication 30. It would provid e a more risk-informed alternative to the generic default values that result in decommissioning fu nding requirements that are not commensurate with anticipated decommissioning costs and associa ted risks to public health and safety. Thus, a rulemaking would ensure that the DFA requireme nts reflect more up-to-date radiation protection principles.

5.2.2 Reduces or Eliminates Exemption Requests

The rulemaking would reduce or eliminate the need for licensees to submit exemption requests for some unlisted radionuclides. In turn, the NRC and the Agreemen t States would no longer need to perform time-consuming and resource-intensive exemption evaluat ions on a case-by-case basis for some unlisted NARM radionuclides.

The impact on Ge-68/Ga-68 generators is a good example of how t his regulatory change would affect licensees. Ge-68, a NARM radionuclide with a half-life of 271 days, exceeds the 120-day half-life criterion. Because Ge-68 is not currently listed in Appendix B to 10 CFR Part 30, the default possession value of 0.1 µCi is used to determine DFA an d DFP requirements. In the current 10 CFR 30.35(a), DFA and DFP requirements apply to radi onuclides with a half-life greater than 120 days in quantities exceeding 1x10 5 times the applicable quantities set forth in Appendix B for unsealed sources and quantities exceeding 1x10 12 times the applicable quantities set forth in Appendix B for sealed sources. In addition, 10 CFR 30.35(b) pr ovides that a licensee can chose to either submit a DFP according to 10 CFR 30.35(e) or submit a DF A certification in the amount prescribed by 10 CFR 30.35(d).

Since Ge-68/Ga-68 generators are not considered a sealed source, the unsealed source value would be applied. Thus, 0.1 µCi or 0.0001 (1x10 -4 mCi) multiplied by 1x105 results in a DFA limit of 10 mCi. Because each new Ge-68/Ga-68 generator has 50 mCi o f Ge-68, the possession of one generator would subject a licensee to DFP requirements in a ccordance with

19 10 CFR 30.35(a)(1). In addition, one new Ge-68/Ga-68 generator at 50 mCi of Ge-68 per generator exceeds the 10 mCi limit for DFA certification under 10 CFR 30.35(d) of $1.125 million.

Therefore, the current regulations would not allow Ge-68/Ga-68 generator licensees the option of submitting a DFA certificate under 10 CFR 30.35(d).

If the NRC updates the value in Appendix B to 10 CFR Part 30 to 10 µCi, the value from Appendix C to 10 CFR Part 20, then the DFA limit for Ge-68/Ga-6 8 generators increases to 1,000 mCi (10 µCi or 0.01 mCi (1x10 -2) multiplied by 1x105 for unsealed sources). As a result, licensees with 50 mCi of Ge-68 in each Ge-68/Ga-68 generator co uld possess up to 20 generators at a time before being subjected to the DFP requirements in 10 CFR 30.35(a)(1). In addition, according to 10 CFR 30.35(d), licensees possessing one or two G e-68/Ga-68 generators (50 to 100 mCi of Ge-68) could provide a $225,000 DFA certificate and not submit a DFP; licensees possessing 3 to 20 generators (>100 to 1,000 mCi) could provide a $1.125 million DFA certificate without being required to develop a DFP. However, this applies only if the licensee does not possess additional radionuclides with half-lives greater than 1 20 days that would have to be considered under the unity rule as discussed in 10 CFR 30.35(a).

Thus, the proposed revisions to Appendix B to 10 CFR Part 30 wo uld provide greater regulatory flexibility than the current regulations; the 200-mCi limit for Ge-68/Ga-68 generators discussed in the ACMUI report described in Section 2.4.1 above; and the NRC exemption guidance also described in Section 2.4.1. The proposed revisions would allow licensees to possess up to 20 generators before reaching the threshold of $1.125 million i n DFA and would not require NRC review and approval of generator return agreements as one condi tion required for approving a site-specific exemption request. Therefore, the proposed rulemaking would reduce or eliminate exemption approval processing del ays for the use of the unliste d Ge-68 and other NARM radionuclides that are important in the diagnosis and treatment of diseases, especially cancer.

5.2.3 Addresses Emerging Technologies

The rulemaking would remove unnecessary decommissioning-related barriers to licensing Ga-68 imaging and other emerging medical and industrial technologies that use or plan to use the unlisted NARM radionuclides. Adding unlisted radionuclides in a single comprehensive rulemaking minimizes the need for additional rulemakings in the future whe n new applications are developed for radionuclides that are not included in the current Appendix B to 10 CFR Part 30.

5.2.4 Alignment of Title and Purpose

Changing the title of Appendix B to 10 CFR Part 30 would elimin ate any confusion between Appendix B to 10 CFR Part 30 and Appendix C to 10 CFR Part 20, differentiating between which regulation should be used for labeling requirements and which r egulation should be used for decommissioning funding requirements. Both appendices are titl ed Quantities of Licensed Material Requiring Labeling. The rulemaking would retitle the table in Appendix B to 10 CFR Part 30 to reflect its purpose for determining DFA. The staff proposes to title 10 CFR Part 30, Appendix B, Quantities of Licensed Material Us ed to Assess Financial Assurance for Decommissioning.

20 5.2.5 Alignment of Listing of Radionuclides and Decommissioning Criteria

The rulemaking would align the listing of radionuclides with th e decommissioning technical basis and criteria in 10 CFR 30.35 that require the amount of DFA to be determined for a given radionuclide with a half-life greater than 120 days, multiplied by the value in Appendix B to 10 CFR Part 30 for the radionuclide. Removing radionuclides wi th a half-life of 120 days or less is consistent with the technical basis that such radionuclides wou ld completely decay in a few years and do not pose significant decommissioning concerns.

Some radioactive materials licensed under 10 CFR Part 70 have a half-life less than or equal to 120 days. Appendix C to 10 CFR Part 20 contains 12 radionuclid es for plutonium that are licensed under 10 CFR Part 70. Seven of these radionuclides have half-l ives greater than 120 days, four have half-lives less than 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br />, and the last radionuclide, Pu-237, has a half-life of 45.2 days.

As a part of the rulemaking, the NRC staff plans to include the seven plutonium radionuclides with half-lives greater than 120 days into the revised Appendix B to 10 CFR Part 30. The NRC staff does not recommend including the four radionuclides with half-l ives less than 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br /> (Pu-234, Pu-235, Pu-243, and Pu-245) in the revised table in Appendix B to 10 CFR Part 30, because they will undergo a minimum of 10 half-lives within 5 days of creati on/possession and will not require special consideration for decommissioning planning. The remain ing radionuclide of plutonium considered (Pu-237) has a half-life of 45.2 days and has been u sed in environmental tracer studies. Pu-237 is produced by bombarding uranium targets with 27 megaelectron volts of helium ions using a cyclotron, and the primary decay mode is by electr on capture to neptunium-237.

While 10 CFR Part 70 does not explicitly exclude this radionucl ide from DFA consideration, Appendix B to 10 CFR Part 30 will include the target material a nd decay products. Accordingly, the NRC staff recommends excluding Pu-237 from the table in App endix B to 10 CFR Part 30 to retain a consistent methodology for revision of Appendix B (i.e., including only radionuclides with half-lives greater than 120 days).

Appendix C to 10 CFR Part 20 includes 11 radionuclides for uran ium. Six of these radionuclides have half-lives greater than 120 days, and the NRC staff recommends including these six radionuclides into a revised Appendix B to 10 CFR Part 30. Fiv e uranium radionuclides have half-lives less than 120 days; the NRC staff recommends excludi ng them (U-230, U-231, U-237, U-239, and U-240) from the revised table in Appendix B to 10 CF R Part 30 because they are source material and are regulated under 10 CFR Part 40, Domest ic licensing of source material, not 10 CFR Part 70. Thus, the staff recommends that 10 CFR 70. 25 include the decommissioning technical basis and criteria that require DFA for radionuclides with a half-life greater than 120 days, revising as follows [emphasis added]:

(a)(2) A specific license authorizing the possession and use of unsealed special nuclear material of half-life greater than 120 days and in quantities exceeding 1x10 5 times the applicable quantities set forth in appendix B to part 30. A decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 1x10 5 is greater than 1 (unity rule), where R is the sum of the ratios o f the quantity of each isotope to the applicable value in appendix B to part 30.

21 (b) Each applicant for a specific license authorizing possessio n and use of unsealed special nuclear material of half-life greater than 120 days, in quantities specified in paragraph (d) of this section, shall either

6. Backfitting and Issue Finality Analysis

The rulemaking would update the values in Appendix B to 10 CFR Part 30 that are used to calculate DFA for byproduct material licenses in accordance wit h 10 CFR 30.35 (10 CFR Part 30 licenses) and for unsealed special nuclear material licenses in accordance with 10 CFR 70.25 (10 CFR Part 70 licenses). There are no backfitting or issue f inality provisions in 10 CFR Part 30.

Although 10 CFR Part 70 contains backfitting provisions, they a re not applicable to the provisions in 10 CFR 70.25. The proposed regulatory changes do not impose modifications of or additions to the systems, structures, components, or design of facilities, n or would they require licensees to modify the procedures or organization required to design, const ruct, or operate facilities. Thus, the proposed changes are not backfits. As a result, no backfit ana lysis is required for this rulemaking.

7. Stakeholder Involvement

Stakeholders have had several opportunities for involvement in this planned rulemaking.

Stakeholders, including the Agreement States, could comment on the OAS petition, as well as participate in a public meeting on this topic on January 7, 202 1. The rulemaking process will provide future opportunities for public engagement.

In addition, the Agreement States participated in the developme nt of this regulatory basis. In accordance with Management Directive 5.3, Agreement State Part icipation in Working Groups, dated June 22, 2016 (ADAMS Accession No. ML18073A142), the staf f provided early opportunities for Agreement State engagement on this rulemaking. A represent ative from the OAS served on the working group that assisted in developing the regulatory ba sis, and an OAS representative is on the rulemaking steering committee. Additionally, the Agreem ent States had an opportunity to review a draft of this regulatory basis and provide comments. The OAS Board, as well as the Agreement States of Arkansas and Wisconsin, provided specific c omments.

The NRC considered these comments in developing this regulatory basis, as described below:

• Wisconsin supported Alternative 2 and indicated that the rulem aking should ease regulatory burden while protecting public health. As this supp orts the current recommendation, the staff did not revise the regulatory basis.

• Arkansas recommended that the staff amend 10 CFR 70.25 to spec ifically include the 120-day half-life criterion to ensure consistency across the re gulations. The NRC agreed and revised this regulatory basis accordingly.

• The OAS Board supported Alternative 5 because it would provide prompt resolution of the petition issue (Alternative 2) combined with a modern, risk-inf ormed resolution (Alternative 4). As discussed in Section 4 of this regulatory basis, the NRC is recommending Alternative 2 because it would result in a more up -to-date and risk-informed

22 approach to DFA without requiring significant time and resource s. At this time, the NRC cannot justify the additional resources to conduct Alternative 4 (as part of Alternative 5).

After receiving public comment on this regulatory basis, the st aff will consider whether its recommended alternative remains advantageous from a safety and cost basis.

In addition, the OAS Board questioned whether Alternative 2 wou ld provide sufficient regulatory relief for Ge-68/Ga-68 generators. In consideration of this comment, the NRC expanded the discussion of the benefits of this rulemaking in S ection 5.2.2 of this regulatory basis. Adding Ge-68 to the list of radionuclides in 10 CFR Part 30, Appendix B, directly addresses the issue with these generators that was the subject of the original petition and eliminates the need for DFPs in many cases. While further relief could be contemplatedsuch as by considering generators akin to sealed s ources for purposes of DFAthis is outside the scope of the recommended rulemaking alt ernative. The OAS Board confirmed that this expanded discussion of the benefits a ddressed their technical questions with Alternative 2.

The staff will consider comments received from stakeholders on this regulatory basis in the development of the proposed rule.

8. Cost/Impact Considerations

This section discusses cost and other impacts related to the ru lemaking for DFA requirements for sealed and unsealed radioactive material. This section discuss es potential impacts on three groups: (1) the NRC, (2) the Agreement States, and (3) licensees. The analyses presented in this section are based on the NRC staffs preliminary assessment. T he staff will carry out a more detailed cost/impact evaluation as part of the regulatory analy sis developed in accordance with NUREG/BR-0058, Revision 5, Regu latory Analysis Guidelines of the U.S. Nuclear Commission, Draft Report for Comment, issued April 2017, during the propos ed rule phase of the rulemaking.

8.1 Applicability

Under 10 CFR 30.35 and 10 CFR 70.25, certain specific NRC licen sees authorized for use or possession of byproduct, source, or special nuclear material ar e subject to DFA requirements.

According to Appendix L to NUREG-1350, Volume 32, 2020-2021 In formation Digest, issued October 2020 (ADAMS Accession No. ML20282A632), the total numbe r of materials licenses issued by the NRC and the Agreement States is 18,664. The tota l number of radioactive material licenses under NRC jurisdiction is 2,209 (12 percent of total l icensees), and the total under Agreement State jurisdiction is 16,455 (88 percent of total lic ensees). Based upon a search of NRCs Web-Based Licensing (WBL) system, 175 (8 percent of 2,209 ) of the NRC radioactive material licensees are, or have recently been, subject to 10 CF R 30.35 or 10 CFR 70.25 financial assurance requirements. By extrapolating based on the number o f licenses in the Agreement States, the NRC estimates that 1,304 Agreement State licenses a re or have recently been subject to financial assurance requirements. Therefore, 1,479 total li censees may be subject to financial assurance requirements. The types of licensees that are subjec t to financial assurance requirements include those authorized under a broad scope licen se and those authorized for medical, industrial, research, nuclear pharmacy, and manufactur er and distributor uses.

23 8.2 Analysis Assumptions

The estimates used in developing the cost estimates are based on a composite of a search of the WBL database and pending financial assurance licensing actions (as these will not be reflected in WBL). The staff subtracted the number of licenses issued under 10 CFR Part 40 in this search from the total number of licenses, since the rulemaking would not apply to 10 CFR Part 40 licensees. The estimates for Agreement State licensees are based on the ratio of the number of licensees under NRC jurisdiction. The cost estimates use only 38 of the current 39 Agreement States. The Wyoming Agreement State assumed the regulation of only uranium recovery from the NRC. Therefore, the State of Wyoming does not have jurisdiction over licensees that would be impacted by this rulemaking and was not included in the cost estimate.

The cost estimates cover several actions that would have to be done by the NRC, the Agreement States, and licensees. The NRC and the Agreement States would have to notify licensees of the rulemaking and the need for licensees to (1) review their licen sed programs for any changes to the amount of required financial assurance or the need for a DFP an d (2) review revised or new financial assurance estimates or DFPs. There are various mecha nisms for DFPs, such as letters of credit, surety bonds, self-guarantee, and statements of inte nt, all of which carry different requirements and costs to put in place.

Many of the NRC licensees that are, or have recently been, subj ect to 10 CFR 30.35 or 10 CFR 70.25 financial assurance requirements (175 based on a s earch of WBL) are large radioactive materials programs such as broad scope licensees, n uclear pharmacies, researchers, manufacturers, and irradiators. These licensees will not see a ny impact on their DFA or DFPs based on the proposed rule. Based on this analysis, the NRC estimates that it would need to notify 60 licensees about the final rule. Of these 60, the NRC estimates that 40 licensees would need to review their financial assurance and may need to revise their financial assurance funding or DFP. For ease of calculations, the NRC used a ratio of 1 NR C licensee to 10 Agreement State licensees to estimate the number of actions for the Agreement S tates (rather than 12 percent to 88 percent as noted above). For industry calculations, the num ber of industry actions is the sum of the number of NRC actions and Agreement State actions.

8.3 Affected Entities

The affected entities are the NRC, the Agreement States, and li censees.

8.3.1 NRC

Based upon a 7-percent discount rate, the NRC estimates that th e NPV projected cost of rulemaking would be approximately ($467,970). NRC implementati on consists of completing the proposed and final rules and developing and issuing licensing g uidance to comply with the new requirements. Additionally, the NRC would incur a NPV projecte d cost of approximately

($129,601) to review licensee revisions to DFA estimates or DFP s. The total NRC NPV projected cost is ($597,571).

8.3.2 Agreement States

The Agreement States will have 3 years to adopt the regulatory changes. The NRC estimates that the NPV cost of this rulemaking to the Agreement States is approximately ($2,049,132) for

24 Agreement State rulemaking and associated changes, assuming a 7-percent discount rate. The Agreement States would also need to review licensee revisions to DFA estimates or DFPs. This rulemaking cost may be lower if the Agreement States choose to incorporate the regulatory changes by reference or by using other legally binding requirements (i.e., license conditions).

8.3.3 Licensees

Assuming a 7-percent discount rate, the NRC estimates that the rule would incur a NPV cost to licensees of approximately ($3,810,315). Those costs would be incurred mainly during the review of its licensed programs and subm ission of necessary revisions to their DFA or DFPs. Additionally, some licensees may need to submit DFA estimates or DFPs for NRC or Agreement State review.

8.3.4 Tribal Nations

The NRC does not expect the rule to affect any Tribal Nations.

8.4 Summary of Alternatives and Cost

Appendix B to this regulatory basis tabulates the assumptions a nd inputs by alternative for each affected entity. Appendix C summarizes Alternatives 2-5 and sh ows the costs for each alternative for the NRC, the Agreement States, and industry. Table 5 summa rizes the estimated costs for each alternative.

The NRC is recommending Alternative 2. Under Alternative 2, th e NRC plans to update Appendix B to 10 CFR Part 30 by replacing the values in the app endix with the values from Appendix C to 10 CFR Part 20. Additionally, the NRC would excl ude all radionuclides with a half-life of 120 days or less from the appendix because these radion uclides are not considered when applying DFA requirements. Finally, to clarify the purpose of Appendix B, the NRC would also change the title of the appendix to reflect its use in determin ing DFA requirements.

Table 5: Alternatives and Benefits (Costs)

DESCRIPTION Net Benefits (Costs) in 2021 Dollars Undiscounted 7% NPV 3% NPV Alternative 1Status Quo (No Action $0 $0 $0 Taken)

Alternative 2Update the List of Radionuclides and the Values i n the Table in Appendix B to 10 CFR Part 30 (NRC selected)

NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 2 NRC ($170,000) ($130,000) ($151,000)

Alternative 2 NRC Averted Cost $2,115,880 $2,075,601 $2,096,936 Alternative 2 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 2 Industry Averted Cost $15,146,546 $13,962,315 $14,589,590 Alternative 2 Agreement States ($2,710,000) ($2,049,000) ($2,398,000)

Alternative 2 Agreement States Averted $15,775,884 $15,115,132 $15,464,247 Cost Alternative 2 Total Net Benefits (Cost) $24,645,904 $24,696,030 $24,668,716

25 DESCRIPTION Net Benefits (Costs) in 2021 Dollars Undiscounted 7% NPV 3% NPV

Alternative 3Partially Update Appendix B to Part 30 (Add unlisted NARM radionuclides and other radionuclides not currently listed to the existing table in Appendix B to 10 CFR Part 30)

NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 3 NRC ($170,000) ($130,000) ($151,000)

Alternative 3 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 3 Agreement States ($2,710,000) ($2,049,000) ($2,398,000)

Alternative 3 Total Net Benefits (Cost) ($8,392,000) ($6,457,000) ($7,482,000)

Alternative 4Develop a New Pr ocess for Assessing Decommissioning Funding Costs NRC Implementation ($518,000) ($468,000) ($495,000)

Alternative 4 NRC ($222,000) ($169,000) ($197,000)

Alternative 4 Industry ($4,995,000) ($3,810,000) ($4,438,000)

Alternative 4 Agreement States ($2,984,000) ($2,249,000) ($2,637,000)

Alternative 4 Total Net Benefits (Cost) ($8,718,000) ($6,697,000) ($7,767,000)

Alternative 5Update Appendix B to 10 CFR Part 30 and Develop a New Process for Assessing Decommissioning Funding Costs (Combines Alternative 2 and Alternative 4 - Two rulemakings)

NRC Implementation ($1,088,000) ($861,000) ($979,000)

Alternative 5 NRC ($392,000) ($259,000) ($326,000)

Alternative 5 Industry ($9,989,000) ($6,717,000) ($8,380,000)

Alternative 5 Agreement States ($5,694,000) ($3,765,000) ($4,741,000)

Alternative 5 Total Net Benefits (Cost) ($17,163,000) ($11,601,000) ($14,427,000)

• Values rounded to the nearest thousand. There may be differences among the tables due to rounding.

• Values in parenthesis, e.g., () denote a cost of negative value.

The rulemaking for DFA requirements for sealed and unsealed rad ioactive material would have a projected cost of approximately $6.5 million over a 15-year per iod for the recommended alternative, Alternative 2. The majority of costs to the NRC, the Agreement States, and industry would be incurred during the first year of implementation of th e final rule. The costs to the industry would include licensees having to review their current DFA or D FPs for any needed revisions to be in compliance with the final rule. Some licensees may need to obtain DFA or submit a DFP as a result of these changes. The NRC and the Agreement States woul d have to review any new or revised DFA estimates or DFPs. In the long run, however, the r ulemaking would save resources and reduce costs, since fewer licensees would need to use defau lt values for determining the amount of DFA or to seek exemptions. The NRC is requesting fee dback from the public on this document to assist in identifying the overall cost that may res ult from the proposed rule to amend 10 CFR Part 30.

9. Uncertainty Analysis

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

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9.1 Uncertainty Analysis Assumptions

As this regulatory analysis uses estimates of values that are s ensitive to licensees unique situations, the staff analyzed the variables that have the grea test 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 cost s and net benefits of the rulemaking. The NRC examined how anticipated savings change du e to uncertainties associated with the NRCs analytical assumptions and input data shown in A ppendix B to this document.

9.2 Uncertainty Analysis Inputs

The probability distributions chosen to represent the different variables in the analysis were bounded by the range-referenced input and the NRC staffs profe ssional judgment. When defining the probability distributions for use in a Monte Carlo simulati on, summary statistics are used to characterize the distributions. These summary statistics includ e the minimum, most likely, and maximum values of a program evaluation and review technique (PE RT) distribution. The staff used the PERT distribution to reflect the relative spread and s kewness of the distribution defined by the three estimatesthe minimum, most likely, and maximum. Figure 1 provides the probability distribution function and the descriptive statistics of the inp uts used in the uncertainty analysis.

Appendix B to this document shows the inputs.

9.3 Uncertainty Analysis Results

Figure 1 depicts the results of the uncertainty analysis of Alt ernative 2 net costs using a 7-percent discount rate. This figure displays the histogram of the incre mental net cost for rulemaking to resolve the identified issues. The uncertainty analysis graph shows that the Alternative 2 mean net cost is ($6.5 million) in 2021 dollars with a 90-percent confidence level that the costs are between

($13.1 million) and ($2.57 million) using a 7-percent discount rate. Note that there will be differences in totals due to the software used to perform the u ncertainty analysis.

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-9.77 -3.80 5.0% 90.0% 5.0%

Alternative 2 Total Net Benefits (Cost) / $0

Minimum -$13,113,977 Maximum -$2,567,543 Mean -$6,454,592 Std Dev $1,814,213 Values 10000

-14 -12 -10 -8 -6 -4 -2 Values in Millions ($)

Figure 1: Incremental Net Costs for Alternative 2 (7-Percent D iscount Rate)

9.4 Sensitivity Analysis

In addition to estimating the probability distributions for the net benefits of the rule, the staff used Monte Carlo simulation to conduct a sensitivity analysis to det ermine the variables that have the greatest impact on the resulting net costs. Variables shown to have a large effect on the resulting net benefits may deserve more attention and scrutiny than varia bles shown to have a small or minimal effect.

Figure 2 shows a tornado diagram that identifies the key variab les 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 Alternative 2 overall results is the licensee labor rate.

The uncertainty in this variable would result in a change to the mean of ($5.8 million), a difference in costs that ranges between ($3.8 million) to ($9.6 million) with a 90-percent confidence level.

The estimate that has the second greatest variation in the Alte rnative 2 overall results is the number of licensees revising their decommissioning plans. The uncertainty in this variable would result in a change to the mean of ($1.5 million), a difference in costs that ranges between

($5.7 million) to ($7.2 million) with a 90-percent confidence l evel.

The estimate that has the third greatest variation in the Alter native 2 overall results is the number of hours required per DFP. The uncertainty variable would resu lt in a change to the mean of

($0.7 million), a difference in costs that ranges from ($6.1 mi llion) to ($6.8 million) with a 90-percent confidence level.

28 The estimate that has the fourth greatest variation in the Alte rnative 2 overall results is the number of industry licensees with revised financial assurance mechanis m values. The uncertainty variable would result in a change to the mean of ($0.6 million), a diffe rence in costs that ranges from

($6.2 million) to ($6.8 million) with a 90-percent confidence l evel. The remainder of the variables result in small or minimal effect on the costs.

Figure 2: Alternative 2 Cost Drivers (7-Percent Discount Rate)

10. Rulemaking Cost Justification

This regulatory basis supports a rulemaking to update Appendix B to 10 CFR Part 30 to include more risk-informed values for the existing radionuclides by usi ng the values provided in Appendix C to 10 CFR Part 20, adding radionuclides not currentl y included, and clarifying that only materials containing radionuclides with half-lives greater than 120 days are subject to DFA and a DFP. Updating the table would lead to aggregated cost savings that would exceed the projected cost of this one-time rulemaking. For example, the current gen eric bounding estimate for the cost of a license exemption is $278,000, consisting of an estimated $188,000 for the licensees development and submittal of a license exemption request and an estimated $90,000 for the NRCs review. As of July 2019, the NRC staff had processed sev en DFP exemption requests for Ge-68/Ga-68 generators at a cost of approximately $1.95 million ($278,000 x 7 DFP exemption reviews). The rulemaking would avert the cost of all such exem ptions in the future. In addition, the NRC has conducted 24 DFP reviews as of December 2021. Fewer of these DFP reviews would be needed after the recommended rulemaking. In addition, the A greement States regulate 87 percent of the materials licensees in the United States. Th erefore, the NRC projects that the averted regulatory costs from reduced exemptions and fewer DFP reviews across the National Materials Program would far exceed the one-time rulemaking cost of $6.5 million.

This rulemaking, in the NRC staffs view, would also have a num ber of additional benefits to licensees, the NRC, and the Agreement States. The proposed cha nges to Appendix B to 10 CFR Part 30 that are incorporated into this rulemaking will provide a more risk-informed method for determining the need for DFA. This includes aligning Appen dix B to 10 CFR Part 30 with the NRCs regulatory authority under the EPAct and the more up-to-d ate radiation protection standards in 10 CFR Part 20. The addition of radionuclides not previousl y included will also reduce the need to use default values that, as noted in the OAS petition, are o ften considered overly burdensome.

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