ML20339A400

Regulatory Basis for Items Containing Byproduct Material Incidental to Production

ML20339A400
Person / Time
Issue date:	01/12/2021
From:	Love-Blair A, Sandra Rodriguez NRC/EDO, Office of Nuclear Material Safety and Safeguards
To:
Sieracki A
Shared Package
ML20339A312	List: ML20339A398 ML20339A400
References
NRC-2015-0017, RIN 3150-AJ54
Download: ML20339A400 (25)

Text

Rulemaking to Allow Exempt Distribution of Products Containing Byproduct Material Incidental to Their Production RIN Number: 3150-AJ54 NRC Docket ID: NRC-2015-0017 Regulatory Basis DocumentDraft for Public Comment

Table of Contents

1. Summary .................................................................................................................................. 1

2. History and Existing Regulatory Framework ............................................................................ 1 2.1 Petition (PRM-30-65) ...................................................................................................... 1 2.2 Existing Regulatory Framework for Irradiated Products Containing Byproduct Material Incidental to Production .................................................................................................. 1

3. Regulatory Problem ................................................................................................................. 2

4. Basis for Proposed Changes ................................................................................................... 4 4.1 Commission Policy Consideration .................................................................................. 4 4.2 Proposed Changes ......................................................................................................... 4 4.3 Guidance ........................................................................................................................ 6

5. Alternatives to Rulemaking ...................................................................................................... 6 5.1 Status Quo ...................................................................................................................... 6 5.2 Guidance ........................................................................................................................ 6

6. Stakeholder Interactions .......................................................................................................... 7

7. Cumulative Effects of Regulation ............................................................................................. 7

8. Compatibility Issues ................................................................................................................. 7

9. Cost/Impact Considerations ..................................................................................................... 8 9.1 Applicability ..................................................................................................................... 8 9.2 Benefits ........................................................................................................................... 8 9.3 Impact on the Agreement States .................................................................................... 8 9.4 Regulatory Flexibility Act ................................................................................................ 9 9.5 Decision Rationale .......................................................................................................... 9 9.6 Cost/Benefit .................................................................................................................. 10

10. Backfit .................................................................................................................................. 10

11. Environmental Analysis ........................................................................................................ 10

12. Support of Strategic Plan ..................................................................................................... 10 References.................................................................................................................................. 11 Appendix A: Assumptions and Assessment Supporting the Cost Analysis ............................. A-1

Regulatory Basis for Amending 10 CFR Part 30 and 10 CFR Part 32 to Allow Exempt Distribution of Products Containing Byproduct Material Incidental to Their Production

1. Summary Items containing byproduct material incidental to their production are irradiated products that serve a useful purpose and contain a minor amount of residual radiation incidental to the production process. The residual byproduct material is not part of the intended end use of the products and, if maintained within appropriate limits, does not present a risk to public health and safety. Current U.S. Nuclear Regulatory Commission (NRC) regulations do not address these items, examples of which include polycarbonate track etched (PCTE) membranes, irradiated gemstones, and certain silicon materials used in the electronics industry.

The NRC is conducting this rulemaking to allow for the licensing of this class of irradiated products under Title 10 of the Code of Federal Regulations (10 CFR) Part 30, Rules of general applicability to domestic licensing of byproduct material, and 10 CFR Part 32, Specific domestic licenses to manufacture or transfer certain items containing byproduct material.

These changes address issues raised in Petition for Rulemaking (PRM)-30-65, Petition for Rulemaking Pursuant to 10 C.F.R. § 2.802 On Behalf of GE Osmonics Inc., dated April 18, 2011 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML120250133), from GE Osmonics, Inc. (the petitioner).

2. History and Existing Regulatory Framework 2.1 Petition (PRM-30-65)

On April 18, 2011, GE Osmonics, Inc., submitted a PRM (PRM-30-65) requesting that the NRC amend its regulations to allow commercial distribution of PCTE membranes. PCTE membranes are used in a variety of research, medical, pharmaceutical, academic, scientific, and industrial applications. The membranes are irradiated to create uniform pore size and distribution, but the manufacturing process leaves behind small amounts of mixed fission products in the membranes. Based on the NRCs review of the product safety analyses submitted by the petitioner (ADAMS Accession No. ML120800277), the incidental radioactivity of these products presents de minimus risk to public health and safety.

The NRC docketed the petition in November 2011. On September 14, 2012, the NRC published a notice in the Federal Register (FR) (77 FR 56793), stating that the petitioner raised a valid regulatory issue about the commercial distribution of PCTE membranes and that the NRC would consider the issue in the rulemaking process.

2.2 Existing Regulatory Framework for Irradiated Products Containing Byproduct Material Incidental to Production Under 10 CFR Part 30, the NRC regulates the manufacturing, production, transfer, receipt, acquisition, ownership, possession, and use of byproduct material. NRC Agreement States maintain compatible regulatory requirements regarding their jurisdiction. Typically, the NRC and Agreement States regulate these processes through a specific or general license. Additionally, the regulations in 10 CFR 30.11, Specific exemptions, through 10 CFR 30.22, Certain industrial devices, provide exemptions from certain licensing requirements. One of these exemptions appears in 10 CFR 30.14, Exempt concentrations.

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Under 10 CFR 30.14, the NRC exempts any person from licensing requirements if the product or material contains byproduct material in concentrations not in excess of those listed in 10 CFR 30.70, Schedule AExempt concentrations. The regulations in 10 CFR 30.14 do not permit the transfer of byproduct material contained in a product that is designed to be ingested, inhaled, or applied to a human being. Additionally, 10 CFR 30.14 does not permit the introduction of byproduct material into a product, even in exempt concentrations, unless the person introducing the byproduct material has a specific license issued under 10 CFR 32.11, Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: Requirements for license.

The regulations in 10 CFR 32.11 provide the requirements for obtaining a specific license authorizing the introduction of byproduct material into a product or material that will eventually be transferred to a person exempt, in accordance with 10 CFR 30.14, from the licensing requirements.

These current regulations do not cover items that contain byproduct material incidental to production; therefore, these items cannot be licensed for exempt transfers. This class of products includes irradiated gemstones; however, in the staff requirements memorandum for SECY-87-186A (ADAMS Accession No. ML092400170), the NRC allowed the interim licensing of irradiated gemstones pursuant to exemptions applied to 10 CFR 32.11 and 10 CFR 30.14. The NRC determined that this practice would not be appropriate for regulating all irradiated items of this type, for the reasons outlined below in Section 3.

3. Regulatory Problem As noted in Section 2, the current regulations in 10 CFR Part 30 and 10 CFR Part 32 do not support the exempt distribution for the class of products containing byproduct material incidental to production.

Specifically, both 10 CFR 30.14 and 10 CFR 32.11 provide that the concentrations of byproduct material in a product not exceed the values listed in Schedule A in 10 CFR 30.70. However, Schedule A would not be appropriate for this class of products for the following reasons.

First, the concentrations in Schedule A pertain to volumetric concentrations in an item containing byproduct material. While volumetric concentrations are useful and appropriate for some products, the NRC is aware of certain products (e.g., polycarbonate membranes, which are thin films) for which volumetric concentrations would not be appropriate due to the products shape. Consequently, the basis for volumetric concentrations in Schedule A would not be applicable to several items that are in this class of products.

Second, the maximum concentration limits of Schedule A are based on the potential internal dose from the product from continuous occupational exposure. Potential exposures from the irradiated products under consideration involve mainly external exposures, and the concentration values, based on continuous internal occupational exposure, are not representative in these situations. Therefore, the Schedule A concentration limits would not be appropriate for this class of products.

Third, the list of radionuclides in Schedule A is not comprehensive for all potential radionuclides in this class of products. While some of the potential radionuclides in these products would fall within the catch-all provision of Schedule A (i.e., beta- or gamma-emitting byproduct material with a half-life less than 3 years), Schedule A will not capture other radionuclides that are in this class of products. For example, PCTE membranes are exposed to nuclear fission fragments, 2

including strontium-90, which remain embedded in the membranes. Schedule A has never specifically included strontium-90 in the table, and strontium-90 would not fall under the catch-all provision of Schedule A because its half-life is more than 27 years. As a result, Schedule A would not include several items that would be in this class of products, such as PCTE membranes, because it does not capture, either specifically or in the catch-all provision, all radionuclides that may be in these products.

Fourth, under the exemption provided by 10 CFR 30.14 and the requirements for a license under 10 CFR 32.11, these irradiated products must not be designed to be ingested, inhaled, or applied to a human being. However, some items in this class of products could be ingested, inhaled, or applied to a human being. As a result, this prohibition makes the current regulatory structure inappropriate for this class of products.

For the reasons noted above, the staff agrees with the petitioner that existing regulatory structure does not support the licensing and distribution of this class of products, under the exempt products category. Nevertheless, these irradiated products are widely used in a variety of beneficial applications, and a regulatory structure provides certainty in a pathway to licensing for this class of products. As a result, revising the regulations is appropriate to allow the potential use of these products under the exemption and distribution provisions in 10 CFR Part 30 and 10 CFR Part 32. The NRC considered alternatives to rulemaking and concluded that these alternatives are not viable for the reasons discussed in Section 5.

During this consideration, the NRC reviewed the International Atomic Energy Agency (IAEA)

Generic Requirements for Consumer Products and IAEA General Safety Requirements (GSR)

Part 3, No. GSR Part 3, General Safety Requirements, which note that the regulatory body, establish[es] the responsibilities of registrants and licensees, of suppliers, and of providers of consumer products in relation to the application of requirements for public exposure in planned exposure situations. Notification is needed with respect to manufacture, maintenance, import, export, provision, distribution and, in some cases, disposal.

The NRC determined that other countries use different processes to implement this IAEA guidance. The NRC uses the Consumer Product Policy Statement and licensing processes to regulate manufacturers/distributors distributing consumer products to minimize public exposures.

IAEA No. SSG-36, Radiation Safety for Consumer Products, and IAEA GSR Part 3 for gemstones states the following:

When considering the licensing of an irradiation and processing facility, the regulatory body should take account of the adequacy of the radiation protection program and quality assurance program in place. In some cases, it may be necessary to regulate the wholesaler/distributor if irradiated gemstones exceeding the exemption criteria will be processed or stored by the wholesaler/distributor prior to being transferred to the retailer.

The program described in IAEA No. SSG-36 and IAEA GSR Part 3 should be considered the minimum necessary to ensure effective control. This program is similar to the NRCs exempt distribution licensing process, which ensures the end products are safe for consumers who will be relieved from all regulations.

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The Canadian Government also requires distribution licenses for distributing irradiated gemstones. The European Union Member States implement the IAEA guidance by allowing the industry to self-regulate, using the IAEA requirements.

4. Basis for Proposed Changes 4.1 Commission Policy Consideration The NRCs Consumer Product Policy Statement states that the NRC should evaluate the overall safety impact of products allowed to be distributed for use by the general public, published in the Federal Register on January 16, 2014 (79 FR 2907). Consumer products are normally used under an exemption from licensing and from all associated regulatory requirements. The policy statement notes that the general criterion for approval of products containing radioactive material depends on the resulting radiation exposures to the public and the apparent usefulness of the product.

The staff would ensure provisions in this rulemaking, should it be approved by the Commission, would be consistent with the NRCs Consumer Product Policy Statement. For the products containing incidental levels of byproduct material associated with this rulemaking, the staff would apply a premise that routine handling, use, and disposal of these products are unlikely to result in a member of the public receiving more than a small fraction (a few millirem (mrem)) of the public dose limits in NRC regulations.

4.2 Proposed Changes The rulemaking would amend 10 CFR Part 30 and 10 CFR Part 32 to (1) add to 10 CFR Part 30 a new class exemption from licensing requirements and (2) add associated distribution requirements to 10 CFR 32.11. These changes would apply dose criteria, rather than concentration, as the primary means of protecting health and safety. These proposed changes would fully address PRM3065, provide a regulatory framework for current (e.g., gemstones) and future irradiated products, and allow this class of products to be licensed without product-specific exemptions that require additional rulemaking in the future. This new regulatory structure would require a licensee to meet only dose-based criteria, which would reduce the burden on current gemstone licensees, who are currently required to provide both concentration and dose-based criteria, as well as limit the NRCs review to only dose-based criteria in the license applications.

In addition to providing dose measurements, the current distributors of irradiated gemstones use a variety of measurements and statistical analysis methods to demonstrate that the concentration of byproduct material at the time of sale to consumers is unlikely to exceed the concentration limits in 10 CFR 30.70 (and derived concentrations for those not specifically included). Under the new provisions, current licensees and applicants (initial distributor or transferrer) would demonstrate that their products are unlikely to result in doses exceeding the dose criteria in the new provisions.

The NRC would amend 10 CFR Part 30 to add a new section specific to products containing byproduct material that is not part of the intended end use of the product but instead is present as a result of production. This new section would only apply to processes that unavoidably result in the incidental addition of byproduct material to the final product. The NRC would add companion paragraphs to 10 CFR 32.11 with the applicable licensing requirements for distribution. The new section in 10 CFR Part 30 would only apply to those products or materials that have an exempt distribution license under 10 CFR 32.11.

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In the past, the NRC has established class exemptions for categories of products or devices with similar characteristics, rather than establishing individual exemptions for each product.

These exemptions appear in 10 CFR 30.19, Self-luminous products containing tritium, krypton-85, or promethium-147; 10 CFR 30.20, Gas and aerosol detectors containing byproduct material; and 10 CFR 30.22, Certain industrial devices. The planned rulemaking approach is similar to that for 10 CFR 30.19, 10 CFR 30.20, and 10 CFR 30.22 in that the regulatory structure would allow new products to be licensed without product-specific exemptions, each of which would otherwise require additional rulemaking. Public health and safety are ensured by evaluating each specific product against safety criteria contained in the regulations that apply to all products in a class.

The new provision would be similar in some respects to the class exemptions in the current regulations in that it would require applicants requesting authorization to distribute a product or material to demonstrate that the product or material would meet certain safety criteria. The NRC specifies these safety criteria in 10 CFR 32.23, Same [specific domestic licenses to manufacture or transfer certain items containing byproduct material]: Safety criteria; 10 CFR 32.27, Same [specific domestic licenses to manufacture or transfer certain items containing byproduct material]: Safety criteria; and 10 CFR 32.31, Certain industrial devices containing byproduct material: Safety criteria. These safety criteria would form the primary means of ensuring adequate protection of public health and safety. Applicants requesting authorization to manufacture, possess, or distribute items containing byproduct material incidental to production would be required to demonstrate compliance with the safety criteria.

These criteria would cover normal use, handling, storage, marketing, distribution, installation, servicing, and disposal as well as potential accidents and misuse.

The NRC would consider the following specific issues in the rulemaking:

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

(a) dose limits to the general public and those occupationally exposed 1 to the product, including through transportation, distribution, use, and disposal (b) prototype testing (if applicable) to demonstrate the degree of binding or containment under the most severe conditions likely to be encountered in normal use of the product (2) Establish ongoing requirements for the exempt distribution of products approved for distribution under the new provision:

(a) labeling requirements for final product packaging (b) quality control/quality assurance 1 Individuals occupationally exposed include users of PCTE membranes, truck drivers, warehouse workers, and waste disposal workers. For the class exemptions, the existing criteria for such groups are 5-20 millirem (mrem)/year (50-200 microsieverts (Sv)/year) except for disposal scenarios, for which the criterion is 1 mrem/year (10 Sv/year), because the same individuals could be impacted by all of the products allowed to be disposed in landfills and municipal incinerators.

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(c) recordkeeping and annual transfer reporting This generic provision would present a more appropriate regulatory framework for irradiated products of this class. It would allow for new products and materials to be developed, evaluated, and licensed under a framework that would adequately protect health and safety without the need for additional rulemaking. The safety criteria would be robust enough to cover any potential future irradiated products. In the long term, these comprehensive proposed changes would be the most cost-effective solution to the NRC and the industry because other irradiated products are expected to be brought to market in the future.

4.3 Guidance Concurrent with the final rule, the staff would issue guidance for these new provisions.

Additionally, the NRC would revise, during its regular revision schedule, NUREG-1556, Consolidated Guidance about Materials Licenses, Volume 8, Revision 1, Program-Specific Guidance About Exempt Distribution Licenses, issued June 2018 (ADAMS Accession No. ML18158A165), which contains guidance for the issuance of licenses authorizing distribution to exempt persons. The NRC would revise this document to include licensing guidance specific to the new provisions in the regulations.

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

5.1 Status Quo Under this alternative, the NRC would continue to rely on existing regulations, orders, and guidance, and no resources would be necessary to perform rulemaking activities. These products are widely used, and this alternative would require each manufacturer, distributor, and user of an irradiated item in this class, except gemstones (see Section 2), to possess a specific license. The resources associated with this approach are outlined in Appendix A. Preparing and evaluating each specific license request would also require NRC resources, as outlined in Appendix A. Further, recognizing the National Materials Program, each Agreement State would need to issue a specific license for these materials, which may cause transboundary issues.

Gemstone licensees would continue to be licensed under the current framework and would continue to provide concentration and dose-based criteria in their applications.

Additionally, this alternative would require the NRC to prepare a Commission paper, a letter to the petitioner, and a Federal Register notice (FRN) to deny the petition and close out PRM-30-65.

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

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6. Stakeholder Interactions Currently, the only stakeholder input on this topic has been in response to the notice of docketing and request for public comment on the petition (76 FR 36386; June 22, 2011). The NRC received one comment letter (ADAMS Accession No. ML11178A021) from a member of the public opposing the petition. The commenter stated that the current regulations do not place an unfair burden on the petitioner and have been in place for some time. The NRC is making this regulatory basis available to the public and requesting comments. The agency will consider those comments in developing the proposed rule.

In accordance with Management Directive 5.3, Agreement State Participation in NRC Working Groups, (ADAMS Accession No. ML18073A142) the staff has provided early opportunity for Agreement State engagement on this rulemaking effort. Specifically, the petition review board included an Agreement State representative. During the process of developing this regulatory basis, the staff gave Agreement States an early opportunity to review the draft and addressed their comments, where appropriate, in finalizing the document. The staff has provided updates during Organization of Agreement States/Conference of Radiation Control Program Directors teleconferences as needed. Going forward, the staff plans to invite an Agreement State representative to participate in the development of the proposed rule.

7. Cumulative Effects of Regulation The NRC has implemented a program to address the possible cumulative effects of regulation in the development of regulatory bases for rulemakings. The cumulative effects of regulation are an organizational effectiveness challenge that results from a licensee or other affected entity implementing several complex positions, programs, or requirements within a prescribed implementation period and with limited available resources, including the ability to access technical expertise to address a specific issue.

The proposed rulemaking activity for items containing byproduct material incidental to production would reduce burden on current gemstone licensees, as well as on the NRC staff reviewing any related license applications, by providing a more streamlined regulatory structure for licensing. For all other irradiated products in this class, this rulemaking removes a barrier to product commercialization by providing a viable means to license the product. The NRC is requesting feedback from the public at the regulatory basis stage on the cumulative effects that may result from any NRC rulemaking to amend 10 CFR Part 30 and 10 CFR Part 32 as described in the regulatory basis.

8. Compatibility Issues Under the Agreement State Program Policy Statement approved by the Commission on October 2, 2017, and published in the Federal Register on October 18, 2017 (82 FR 48535),

NRC program elements required for adequacy to provide for an acceptable level of protection of public health and safety are those that are designated as Categories A, B, C, D, NRC, and H&S (Health & Safety). Those required for compatibility with the NRCs regulatory program include those program elements designated as Compatibility Categories A, B, C, and D. The NRC anticipates the new exemption in 10 CFR Part 30 to be designated as Compatibility Category B and the associated requirements for distributors in 10 CFR Part 32 as Category NRC.

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

9.1 Applicability The proposed changes would provide a regulatory framework for the distribution of irradiated products (e.g., gemstones and PCTE membranes) for current and future NRC licensees.

Licensees currently distributing irradiated gemstones under 10 CFR 32.11, for use under 10 CFR 30.14, can amend their licenses to comply with the new provisions at the time of the next license renewal. These new provisions will be substantially less burdensome because the licensee would not need exemptions under the new provision and would not be required to submit the concentration data for review.

Without this rulemaking, potential applicants would need to apply for a specific license to distribute these products, and the end user would need to obtain a possession license to use the products, resulting in additional cost. These costs make the distribution of items such as PCTE membranes and future irradiated products financially challenging, using the current regulatory structure.

9.2 Benefits In addition to quantitative benefits, the staff expects the proposed action to provide the following qualitative benefits:

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

• Provide an appropriate pathway for licensing these beneficial irradiated products that are used in a wide variety of applications. Items like PCTE membranes can be made without creating byproduct material incidental to production; however, the industry prefers to use this method to create membranes with uniform pore size and distribution.

• Ensure consistency for regulating different products in this class.

• As described in Table 1, avert an estimated cost of $10,853,000, by pursuing rulemaking, which includes the cost of updating guidance and developing a compliance guide for regulations that affect small entities.

9.3 Impact on the Agreement States The Agreement States would have 3 years to adopt the regulatory changes. This rulemaking will have a cost to the Agreement States of approximately $1.36 million at a 7-percent discount rate for Agreement State rulemaking and associated changes. This Agreement State cost is conservative. Those Agreement States that incorporate by reference would have lower costs in comparison to other States.

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9.4 Regulatory Flexibility Act The Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act, requires the NRC to consider the impact of its rulemakings on small entities and evaluate alternatives that would accomplish regulatory objectives without unduly burdening small entities or erecting barriers to competition. In developing the proposed rule, the staff will evaluate how many small entities it anticipates this rulemaking would affect and what steps the NRC can take to mitigate the economic impacts on small entities. The staff will use public comments received on this document to inform this analysis. The final net averted cost estimated for this rulemaking, as compared to status quo, of

$10,853,000 includes the cost of updating guidance and developing a compliance guide for regulations that affect small entities.

9.5 Decision Rationale The NRC estimates that the rulemaking would take approximately 3 years to complete and require the time of 4.2 full-time equivalent staff. The rulemaking implementation would result in a cost of ($780,000) to the NRC using a 7-percent discount rate. The rulemaking implementation would result in a cost of ($1,365,000) to the Agreement States using a 7-percent discount rate. This results in a total implementation cost of ($2,145,000) to the NRC and the Agreement States using a 7-percent discount rate, which is shown as a separate line item in Table 1, Alternative 2, Item A. Adding the costs for Item A ($2,145,000), Item B

($10,315,000), and Item C ($150,000); the averted costs of $73,000 from Item D; and the Averted Alternative 1 costs of $23,390,000, the final net averted cost for Alternative 2 is

$10,853,000.

Status Quo The NRC estimates that resuming the status quo will incur a cost of ($23.4 million) at a 7-percent discount rate due to the cost of discontinuing rulemaking. These costs stem from the need to prepare a SECY paper, a letter to the petitioner denying the petition, and an FRN.

Additionally, this option includes the costs to review initial license applications and subsequent renewals, including costs to end users that are required to have a license.

Staff-Recommended Rulemaking Table 1 also shows the staff-recommended rulemaking actions. The Alternative 2 net averted cost is $10,853,000, which comprises industry averted costs of $791,000, NRC averted costs of

$11,427,000, and Agreement State costs of ($1,365,000) to update their regulations to be compatible with the NRCs. Table 1, Alternative 2, shows the net costs to licensees, the NRC, and Agreement States.

Table 1 Total Net Costs by Affected Entity Agreement Industry NRC Total (2020$) a b c Description States 7% NPV 7% NPV 7% NPV 7% NPV Alternative 1 Status QuoDo Nothing Different NRC Rulemaking Discontinuation Costs (SECY, Letter, and FRN) $0 ($100,000) $0 ($100,000)

License Distributors and End Users ($11,055,000) ($12,235,000) $0 ($23,290,000)

Alternative 1 Net (Costs) Benefits ($11,055,000) ($12,335,000) $0 ($23,390,000) 9

Alternative 2 Proceed with a Rulemaking Inclusive of Items Containing Byproduct Material Incidental to Production (staffs recommendation)

Item A: Rulemaking Implementation Costs Excluding Rulemaking Termination Costs $0 ($780,000) ($1,365,000) ($2,145,000)

Item B: PCTE Only ($10,228,000) ($87,000) $0 ($10,315,000)

Item C: Silica Chip Only ($71,000) ($79,000) $0 ($150,000)

Item D: Gemstone Only Regulated 10 CFR 32.11(c) Exemption $35,000 $38,000 $0 $73,000 Averted Alternative 1 Costs $11,055,000 $12,335,000 $0 $23,390,000 Alternative 2 Net (Costs) Benefits $791,000 $11,427,000 ($1,365,000) $10,853,000 a

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

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

c There may be differences between table summations due to rounding.

9.6 Cost/Benefit Based on the cost estimates shown in Table 1, the NRC concludes that the rulemaking alternative inclusive of all items containing byproduct material incidental to production is the best course of action, because the qualitative benefits discussed in Section 9.2 exceed the cost of implementing this rulemaking.

The new provisions would become applicable to current licensees at the time of their next license renewal. These new provisions will be substantially less burdensome because the licensee would not need a special exemption under the new provision.

10. Backfit The proposed revisions to 10 CFR Part 30 and Part 32 do not constitute backfitting because such licensees are not the subject to any backfit or issue finality provisions.

11. Environmental Analysis This rulemaking would add new provisions to 10 CFR Part 30 and 10 CFR Part 32. Pursuant to 10 CFR 51.21, Criteria for and identification of licensing and regulatory actions requiring environmental assessments, the NRC will develop an environmental assessment along with this rulemaking to determine whether issuing this rule will result in any significant impacts.

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

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The planned rulemaking also supports NRCs Principles of Good Regulation, specifically the principles of openness, clarity, and reliability. The rulemaking process ensures openness with the public, and the proposed changes are based on the best available knowledge to ensure regulations that are clear and reliable. Although, irradiated materials in this class do not present a risk to public health and safety, if maintained within appropriate limits, vendors of these materials seek a viable regulatory pathway for these products with regulatory openness, clarity, and reliability. Closing this regulatory gap, through the planned rulemaking, would ensure a clear and reliable framework for these materials to be licensed.

References

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

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

3. GE Osmonics, Inc., Environmental ReportPolymer Track Etch Membrane 10 C.F.R. § 30.15, received March 20, 2012 (ADAMS Accession No. ML120800264).

4. Consumer Product Policy Statement, 79 FR 2907, January 16, 2014.

5. NUREG-1556, Volume 8, Revision 1, Consolidated Guidance about Materials Licenses:

Program-Specific Guidance About Exempt Distribution Licenses, June 2018 (ADAMS Accession No. ML18158A165).

6. Petition for Rulemaking Submitted by Annette User on Behalf of GE Osmonics, Inc.,

77 FR 56793, September 14, 2012.

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

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

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

10. Petition for Rulemaking Submitted by Annette User on Behalf of GE Osmonics, Inc.,

76 FR 36386, June 22, 2011.

11. Comment (1) of Benjamin Kerensa Opposing Petition for Rulemaking (PRM-30-65)

Regarding the NRC Amend Its Regulations Regarding the Commercial Distribution of Byproduct Material, received June 23, 2011 (ADAMS Accession No. ML11178A021).

12. Management Directive 5.3, Agreement State Participation in NRC Working Groups, June 22, 2016 (ADAMS Accession No. ML18073A142).

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13. Agreement State Program Policy Statement; Correction, 82 FR 48535, October 18, 2017.

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

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Appendix A: Assumptions and Assessment Supporting the Cost Analysis Table of Contents Appendix A: Assumptions and Assessment Supporting the Cost Analysis.......................... A-1 Uncertainty Analysis ................................................................................................................. A-2 Uncertainty Analysis Assumptions ....................................................................................... A-2 Uncertainty Analysis Results ................................................................................................ A-2 Data Tables............................................................................................................................... A-5 List of Figures Figure A-1 Incremental Net Costs for Alternative 2 (7-Percent Discount Rate) ....................... A-3 Figure A-2 Alternative 2 Cost Drivers (7-Percent Discount Rate) ............................................ A-4 List of Tables Table A-1 Data Sheet .............................................................................................................. A-5 Table A-2 Alternative 1 Status Quo - Do Nothing Different -- NRC Rulemaking Discontinuation Cost........................................................................................................................................... A-7 Table A-3 Alternative 1 Status Quo - Do Nothing Different -- NRC Review of PCTE End User License Applications ................................................................................................................. A-7 Table A-4 Alternative 1 Status Quo - Do Nothing Different -- NRC Review of PCTE Manufacturers and/or Distributors Initial License Applications ................................................. A-8 Table A-5 Alternative 1 Status Quo - Do Nothing Different -- PCTE End User Licensees Status Quo Expenses .......................................................................................................................... A-8 Table A-6 Alternative 1 Status Quo - Do Nothing Different -- PCTE Manufacturers and Distributors Status Quo Expenses ............................................................................................ A-8 Table A-7 Alternative 2 - Agreement States Rulemaking Implementation Costs ..................... A-9 Table A-8 NRC Rulemaking Implementation Cost ................................................................... A-9 Table A-9 PCTE Licensee Implementation Costs .................................................................... A-9 Table A-10 NRC Costs to Issue PCTE Licenses ................................................................... A-10 Table A-11 Silica Chip Entity Implementation Costs .............................................................. A-10 Table A-12 NRC Costs to Issue Silica Chip Licenses ............................................................ A-10 Table A-13 Gemstone Entity Implementation ........................................................................ A-11 Table A-14 Averted NRC Gemstone Exemption Costs ......................................................... A-11 A-1

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

Uncertainty Analysis Assumptions As this regulatory analysis uses estimates of values that are sensitive to unique certificate holders situations, the staff analyzed the variables that have the greatest amount of uncertainty.

To perform this analysis, the staff used a Monte Carlo simulation analysis using the @Risk software program.

Monte Carlo simulations involve introducing uncertainty into the analysis by replacing the point estimates of the variables used to estimate base case costs and benefits with probability distributions. By defining input variables as probability distributions instead of point estimates, the influence of uncertainty on the results of the analysis (in other words, the net benefits) can be effectively modeled.

The probability distributions chosen to represent the different variables in the analysis were bounded by the range-referenced input and the staffs professional judgment. When defining the probability distributions for use in a Monte Carlo simulation, summary statistics are used to characterize the distributions. These summary statistics include the minimum, most likely, and maximum values of a program evaluation and review technique (PERT) distribution. The staff used the PERT distribution to reflect the relative spread and skewness of the distribution defined by the three estimates, the minimum, most likely, and maximum. Appendix A, Figure A-1 of this document provides the probability distribution function and the descriptive statistics of the inputs used in the uncertainty analysis.

Uncertainty Analysis Results The NRC performed the Monte Carlo simulation by repeatedly calculating the results 10,000 times. Appendix A provides the inputs used in the uncertainty analysis and additional information regarding the uncertainty analysis results.

For each iteration, the variable values in Appendix A were chosen randomly from the probability distributions that define the input variables. The values of the output variables were recorded for each iteration, and these resulting output variable values were used to define the resultant probability distribution.

The results of the uncertainty analysis of Alternative 2 net costs using a 7-percent discount rate are provided graphically in Figure A-1. This figure displays the histogram of the incremental net cost for rulemaking to resolve the identified issues. The uncertainty analysis graph showing the net result is reported in 2020 dollars. The analysis shows that Alternative 2 is cost beneficial for all 10,000 simulations with a 90-percent confidence interval that the net costs are between

$6.5 million and $49.6 million using a 7-percent discount rate.

A-2

12.37 32.02 5.0% 90.0% 5.0%

Net Benefits and (Costs) / 7% NPV Minimum $6,506,000 Maximum $49,575,000 Mean $21,021,026 Std Dev $6,046,463 Values 10000 5 10 15 20 25 30 35 40 45 50 Values in Millions ($)

Figure A-1 Incremental Net Costs for Alternative 2 (7-Percent Discount Rate)

Figure A-2 shows a tornado diagram that identifies the key variables whose uncertainty drives the largest impact on net benefits for this recommended alternative. Figure A-2 ranks the variables based on their contribution to cost uncertainty.

The estimate that has the greatest variation in the overall results is the status quo NRC review of PCTE end users applications. The uncertainty in this variable would result in a change to the mean of $11.7 million, the difference in costs that ranges between $16.2 million to $28.0 million with a 90 percent confidence level.

The estimate that has the second greatest variation in the overall results is the status quo PCTE end users initial license applications. The uncertainty in this variable ranges would result in a change to the mean of $10.5 million, the difference in costs that ranges between $16.6 million to

$27.1 million with a 90 percent confidence level.

The estimate that has the third greatest variation in the overall results is the licensee labor rate.

The uncertainty in this labor rate would result in a change to the mean of $10.3 million, the difference in costs that ranges $16.2 million to $26.5 million with a 90 percent confidence level.

A-3

eview PCTE End User Initial License Applications $16,222,855 $27,950,369 Input High Alt 1: PCTE End Users Initial Applications $16,552,852 $27,075,551 Input Low Licensee Labor Rate $16,192,291 $26,531,690 Baseline = $21,021,026 16 18 20 22 24 26 28 Net Benefits and (Costs) / 7% NPV Values in Millions ($)

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

A-4

Data Tables Table A-1 Data Sheet Mean Low Best High Description Distribution Estimate Estimate Estimate Estimate Alternative 1 Status Quo - Do Nothing Different NRC Rulemaking Discontinuation Costs Prepare Rulemaking Discontinuation 820 Pert 738 820 902 SECY, Letter and FRN (Hours)

NRC Labor Rate $131 NRC Review of PCTE End User Licensees Status Quo Expenses Number of PCTE End User Licensees 2,000 Pert 1,600 2,000 2,400 NRC Review of Licensee End Users 50 Pert 20 40 120 Initial Applications (Hours)

NRC Review of Licensee End Users 25 Pert 10 20 60 Renewal Applications (Hours)

NRC Labor Rate $131 NRC Review of PCTE Manufacturers and Distributors Status Quo Expenses Number of PCTE Manufacturers and 9 Pert 8 9 10 Distributors NRC Review of Manufacturers and 100 Pert 90 100 110 Distributors Initial Applications (Hours)

NRC Review of Manufacturers and 50 Pert 45 50 55 Distributors Renewal Applications (Hours)

NRC Labor Rate $131 PCTE End User Licensees Status Quo Expenses Number of PCTE End User Licensees 2,000 Pert 1,600 2,000 2,400 Licensee End Users Initial Applications 50 Pert 20 40 120 (Hours)

Licensee End Users Renewal 25 Pert 10 20 60 Applications (Hours)

Licensee Average Labor Rate $118 Pert $77.17 $96.95 $166.01 PCTE Manufacturers and/or Distributors Status Quo Expenses Number of PCTE Manufacturers and 9 Pert 8 9 10 Distributors Manufacturers and Distributors Initial 100 Pert 90 100 110 Applications (Hours)

Manufacturers and/or Distributors 50 Pert 45 50 55 Renewal Applications (Hours)

Licensee Average Labor Rate $118 Pert $77.17 $96.95 $166.01 Alternative 2 Proceed with a Rulemaking Inclusive of Items Containing Byproduct Material Incidental to Production (staffs recommendation)

Agreement States Rulemaking Implementation Costs Number of Agreement States 38 Agreement State Rulemaking Activities 527 Pert 316 527 738 (Hours)

Agreement States Labor Rate $95 Pert $86 $95 $105 Alternative 2 Licensee & NRC Rulemaking Costs Item A NRC Rulemaking Rulemaking and Use Existing Guidance 1 Pert 0.9 1 1.1 NRC Rulemaking Activities (Hours) 6,342 Pert 5,708 6,342 6,976 A-5

Mean Low Best High Description Distribution Estimate Estimate Estimate Estimate NRC Labor Rate $131 Item B: PCTE Only Item B (Licensee) PCTE Only PCTE Manufacturers and Distributors 9 Pert 8 9 10 (Number of License Submittals)

PCTE Licensee Hours (Licensee 60 Pert 54 60 66 Application Development)

PCTE Licensee Labor Rate $118 Pert $77.17 $96.95 $166.01 Item B (NRC) PCTE Only PCTE (NRC) 9 Pert 8 9 10 NRC Review and Processing Time per 60 Pert 54 60 66 Submittal (Hours)

NRC Labor Rate $131 Item B NRC Review of PCTE End User Licensees Status Quo Expenses Reflected as Savings in Alt 2 Number of PCTE End User Licensees 0 NRC Review of Licensee End Users 50 Pert 20 40 120 Applications (Hours)

NRC Labor Rate $131 Item B NRC Review of PCTE Manufacturers and/or Distributors Status Quo Expenses Reflected as Savings in Alt 2 Number of PCTE Manufacturers and 0

Distributors NRC Review of Manufacturers and 100 Pert 90 100 110 Distributors Applications (Hours)

NRC Labor Rate $131 Item C: Silica Chip Only Item C (Licensee) Silica Chip Only NRC Review of Number of Silica Chip 9 Pert 8 9 10 Licensee Submittals NRC Review and Processing Time per Submittal of Silica Chip Licensees 60 Pert 54 60 66 (Hours)

Silica Chip Licensee Labor Rate $118 Pert $77.17 $96.95 $166.01 Item C (NRC) Silica Chip Only NRC Silica Chip Review of Submittals 9 Pert 8 9 10 NRC Time (Hours) 60 Pert 54 60 66 NRC Labor Rate $131 Item D: Gemstone Only Regulated §32.11(c) Exemption Item D (Licensee) Gemstone Only Regulated §32.11(c) Exemption Number of Gemstone Exemptions 9 Pert 8 9 10 Gemstone Entity Licensee Hours 40 Pert 36 40 44 Gemstone Entity Licensee Labor Rate $118 Pert $77.17 $96.95 $166.01 Item D (NRC) Gemstone Only Regulated §32.11(c) Exemption NRC Review of Gemstone Submittals 9 Pert 8 9 10 Only NRC Review and Processing Time 40 Pert 36 40 44 (Hours)

NRC Labor Rate $131 A-6

For cost analysis considerations, the staff estimates for Alternative 1 NRC Rulemaking Discontinuation a cost of ($100 thousand) using a 7 percent discount rate to discontinue rulemaking. This cost includes preparing a SECY, a letter to the petitioner to inform them of the denial of the petition, and an FRN. This cost is shown in Table A-2.

Table A-2 Alternative 1 Status Quo - Do Nothing Different -- NRC Rulemaking Discontinuation Cost NRC NRC Labor Year Description Undiscounted 7% NPV 3% NPV Hours Rate NRC Rulemaking Discontinuation Costs 2021 820 $131 ($107,420) ($100,393) ($104,291)

(Cost of SECY, Letter, and FRN)

Net (Cost) Benefit ($107,420) ($100,393) ($104,291)

For cost analysis considerations, the staff estimates a cost for Alternative 1 NRC review of PCTE end user license applications a cost of ($12.1 million) using a 7 percent discount rate.

The estimated number of PCTE end user licensees is 4,000. This cost is shown in Table A-3.

Table A-3 Alternative 1 Status Quo - Do Nothing Different -- NRC Review of PCTE End User License Applications NRC review Number of Licensee NRC of PCTE End Users Year Description Labor Undiscounted 7% NPV 3% NPV End User Initial Rate Licensees Applications (Hours)

NRC Review of PCTE End User 2022 400 50 $131 ($2,620,000) ($2,288,409) ($2,469,601)

Initial License Applications NRC Review of PCTE End User 2023 400 50 $131 ($2,620,000) ($2,138,700) ($2,397,671)

Initial License Applications NRC Review of PCTE End User 2024 400 50 $131 ($2,620,000) ($1,998,785) ($2,327,836)

Initial License Applications NRC Review of PCTE End User 2025 400 50 $131 ($2,620,000) ($1,868,024) ($2,260,035)

Initial License Applications NRC Review of PCTE End User 2026 400 50 $131 ($2,620,000) ($1,745,817) ($2,194,209)

Initial License Applications NRC Review of PCTE End User 2037 2,000 25 $131 ($6,550,000) ($2,073,562) ($3,962,858)

Renewal License Applications Net (Cost) Benefit 4,000 ($19,650,000) ($12,113,298) ($15,612,210)

For cost analysis considerations, the staff estimates for Alternative 1 NRC review of PCTE manufacturers and distributors license applications a cost of ($122 thousand) using a 7 percent discount rate. The NRC estimated that there are nine PCTE Manufacturers and/or distributor licensees. This cost is shown in Table A-4.

A-7

Table A-4 Alternative 1 Status Quo - Do Nothing Different -- NRC Review of PCTE Manufacturers and/or Distributors Initial License Applications Number of NRC Review PCTE NRC of License Year Description Manufacturers Labor Undiscounted 7% NPV 3% NPV Applications and Rate (Hours)

Distributors NRC Review of PCTE 2022 Manufacturers and Distributors 9 100 $131 ($117,900) ($102,978) ($111,132)

Initial License Applications NRC Review of PCTE 2037 Manufacturers and/or Distributors 9 50 $131 ($58,950) ($18,662) ($35,666)

Renewal License Applications Net (Cost) Benefit ($176,850) ($121,640) ($146,798)

The staff estimates a cost of ($10.9 million) at a 7-percent discount rate for Alternative 1. The NRC estimates that there would be 2,000 PCTE end user licensees with one licensee renewal.

This cost is shown in Table A-5.

Table A-5 Alternative 1 Status Quo - Do Nothing Different -- PCTE End User Licensees Status Quo Expenses Number of Licensee Licensee PCTE End End Average Year Description Undiscounted 7% NPV 3% NPV User Users Labor Licensees (Hours) Rate PCTE End User Initial 2022 400 50 $118 ($2,364,851) ($2,065,552) ($2,229,099)

License Submittal PCTE End User Initial 2023 400 50 $118 ($2,364,851) ($1,930,423) ($2,164,174)

License Submittal PCTE End User Initial 2024 400 50 $118 ($2,364,851) ($1,804,133) ($2,101,139)

License Submittal PCTE End User Initial 2025 400 50 $118 ($2,364,851) ($1,686,106) ($2,039,941)

License Submittal PCTE End User Initial 2026 400 50 $118 ($2,364,851) ($1,575,800) ($1,980,525)

License Submittal PCTE End User 2037 Renewal License 2,000 25 $118 ($5,912,127) ($1,871,628) ($3,576,934)

Submittal Net (Cost) Benefit 4,000 ($17,736,381) ($10,933,642) ($14,091,812)

The staff estimates a cost of ($122 thousand) at a 7-percent discount rate for Alternative 1. The analysis estimates nine PCTE manufacturers and distributors would undergo initial licensing in 2022 and license renewal in 2037. This cost is shown in Table A-6.

Table A-6 Alternative 1 Status Quo - Do Nothing Different -- PCTE Manufacturers and Distributors Status Quo Expenses Number of Licensee Manufacturers PCTE Average Year Description and Distributors Undiscounted 7% NPV 3% NPV Manufacturers Labor (Hours) and Distributors Rate PCTE Manufacturers and 2022 Distributors Initial 9 100 $131 ($117,900) ($102,978) ($111,132)

License Submittal PCTE Manufacturers and 2037 Distributors Renewal 9 50 $131 ($58,950) ($18,662) ($35,666)

License Submittal Net (Cost) Benefit ($176,850) ($121,640) ($146,798)

A-8

For cost analysis considerations, the staff estimates Agreement States rulemaking implementation costs of ($1.4 million) at a 7-percent discount rate as shown in Table A-7.

Table A-7 Alternative 2 - Agreement States Rulemaking Implementation Costs Number of Agreement Rulemaking Year Description Agreement States Undiscounted 7% NPV 3% NPV Hours States Labor Rate Agreement States 2024 13 527 $95 ($652,662) ($497,913) ($579,882)

Rulemaking Agreement States 2025 13 527 $95 ($652,662) ($465,339) ($562,992)

Rulemaking Agreement States 2026 12 527 $95 ($602,457) ($401,443) ($504,549)

Rulemaking Net (Cost) Benefit 38 ($1,907,782) ($1,364,695) ($1,647,422)

For cost analysis considerations, the staff estimates for NRC rulemaking implementation costs of ($780 thousand) at a 7-percent discount rate as shown in Table A-8.

Table A-8 NRC Rulemaking Implementation Cost NRC NRC Hourly Year Activity Undiscounted 7% NPV 3% NPV Hours Rate Develop Regulatory Guide 2020 480 $131 ($62,906) ($62,906) ($62,906)

(RG) for Proposed Rule 2020 Develop Proposed Rule 1,305 $131 ($170,929) ($170,929) ($170,929)

Revise RG After Public 2020 480 $131 ($62,906) ($62,906) ($62,906)

Comments 2021 Develop RG For Final Rule 636 $131 ($83,338) ($77,886) ($80,910) 2021 Develop Final Rule 1,478 $131 ($193,556) ($180,893) ($187,918)

Develop Comment Resolution 2022 561 $131 ($73,492) ($64,191) ($69,274) for Final Rule 2022 Complete Final Rule 1,402 $131 ($183,600) ($160,363) ($173,060)

Net (Cost) Benefit 6,341 ($830,727) ($780,074) ($807,904)

The staff estimates an average of 9 PCTE entities will apply for licenses under the new regulations. In order to comply with the new regulations, PCTE licensees will need to submit an initial application and a renewal application at 15 years. The estimated number of hours per application ranges from a low of 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> to a high estimate of 66 hours7.638889e-4 days <br />0.0183 hours <br />1.09127e-4 weeks <br />2.5113e-5 months <br /> with a mean value of 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> as shown in Table A-9. This results in a cost of ($79 thousand) at a 7-percent discount rate as shown in Table A-9.

Table A-9 PCTE Licensee Implementation Costs PCTE Number of Labor Year Description Licensee Undiscounted 7% NPV 3% NPV PCTE Licenses Rate Hours 2023 PCTE Licensing 9 60 $118 ($63,861) ($59,674) ($61,991) 2038 PCTE Licensing 9 60 $118 ($63,851) ($18,891) ($37,506)

Net (Cost) Benefit ($127,702) ($78,565) ($99,497)

A-9

The staff estimates that PCTE entities will submit an initial application and a renewal application at 15 years. The estimated number of hours to review the initial and renewal application and issue the licenses ranges from a low of 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> to a high estimate of 66 hours7.638889e-4 days <br />0.0183 hours <br />1.09127e-4 weeks <br />2.5113e-5 months <br /> with a mean value of 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br />. This results in a cost of ($87 thousand) at a 7-percent discount rate as shown in Table A-10.

Table A-10 NRC Costs to Issue PCTE Licenses Number of NRC NRC Year Description PCTE License Labor Undiscounted 7% NPV 3% NPV Hours Applications Rate 2023 NRC Licensing PCTE Entities 9 60 $131 ($70,740) ($57,745) ($64,737) 2038 NRC Licensing PCTE Entities 9 60 $131 ($70,740) ($20,929) ($41,552)

Net (Cost) Benefit ($141,480) ($87,042) ($110,232)

The staff estimates an average of 9 silica chip entities will apply for licenses under the new regulations. The number of hours per application ranges from a low of 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> to a high estimate of 66 hours7.638889e-4 days <br />0.0183 hours <br />1.09127e-4 weeks <br />2.5113e-5 months <br /> with a mean value of 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br />. This results in a cost of ($71 thousand) a 7-percent discount rate as shown in Table A-11.

Table A-11 Silica Chip Entity Implementation Costs Number of Silica Chip Licensee Labor Year Description Undiscounted 7% NPV 3% NPV License Hours Rate Applications Silica Chip Entity Initial License 2023 9 60 $118 ($63,651) ($52,121) ($58,433)

Application Submittal 2038 Silica Chip Entity Licensing 9 60 $118 ($63,651) ($18,891) ($37,506)

Net (Cost) Benefit ($127,702) ($71,013) ($95,938)

The staff estimates that nine silica chip entities will submit an initial application and a renewal application at 15 years. The estimated number of hours to review the initial and renewal application and issue the licenses ranges from a low of 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> to a high estimate of 66 hours7.638889e-4 days <br />0.0183 hours <br />1.09127e-4 weeks <br />2.5113e-5 months <br /> with a mean value of 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> This results in a cost of ($79 thousand) at a 7-percent discount rate as shown in Table A-12.

Table A-12 NRC Costs to Issue Silica Chip Licenses Number of NRC Silica Chip Year Description Hours Labor Undiscounted 7% NPV 3% NPV License Rate Applications NRC Licensing Silica Chip 2023 9 60 $131 ($70,740) ($57,745) ($64,737)

Entities NRC Licensing Silica Chip 2038 9 60 $131 ($70,740) ($20,929) ($41,552)

Entities Net (Cost) Benefit ($141,480) ($78,674) ($106,289)

A-10

The staff estimates an average of 9 gemstone licensees complying with the new regulations.

The number of hours saved, when complying with the new regulations, ranges from a low of 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> to a high estimate of 44 hours5.092593e-4 days <br />0.0122 hours <br />7.275132e-5 weeks <br />1.6742e-5 months <br /> with a mean value of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />. This results in an averted cost of $35 thousand a 7-percent discount rate as shown in Table A-13.

Table A-13 Gemstone Entity Implementation Number of Gemstone Labor Year Description Hours Undiscounted 7% NPV 3% NPV Exemptions Rate Averted 2023 Gemstone Exemptions Averted 9 40 $118 $42,567 $34,748 $38,955 Net (Cost) Benefit $42,567 $34,748 $38,955 The staff estimates an average of 9 gemstone licensees complying with the new regulations.

The number of hours saved to issue exemptions covering gemstone entities ranges from a low of 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> to a high estimate of 44 hours5.092593e-4 days <br />0.0122 hours <br />7.275132e-5 weeks <br />1.6742e-5 months <br /> with a mean value of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />. This results in an averted cost of $38 thousand a 7-percent discount rate as shown in Table A-14.

Table A-14 Averted NRC Gemstone Exemption Costs Number of NRC Gemstone Year Description Hours Labor Undiscounted 7% NPV 3% NPV Exemptions Rate Averted NRC Exemption 2023 9 40 $131 $47,160 $38,497 $43,158 Processing Averted Net (Cost) Benefit $47,160 $38,497 $43,158 A-11