ML21005A004

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NRC Presentation Decommissioning Financial Assurance Requirements for Sealed and Unsealed Radioactive Material
ML21005A004
Person / Time
Issue date: 01/07/2021
From: Thomas Taylor
NRC/NMSS/DREFS/MRPB
To:
Taylor Torre
References
20201381
Download: ML21005A004 (42)
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Text

Decommissioning Financial Assurance Requirements for Sealed and Unsealed Radioactive Material Webinar Link (presentation)

Audio: Bridge Number: (877) 910-5948 Passcode: 4930474

  • Meeting audio is through the bridge line only

- Call (877) 910-5948, enter passcode 4930474

  • Participants in listen-only mode until the public comment portion of the meeting

- To comment, press *1 on your phone and wait for the operators instructions

  • Slides are available in the NRCs Agencywide Documents Access and Management System (ADAMS) at ML21005A004 2

Decommissioning Financial Assurance Requirements for Sealed and Unsealed Radioactive Material January 7, 2021

Topic Speaker Opening Remarks Patricia Holahan, Ph.D.

Introduction/Meeting Logistics Torre Taylor Sarah Lopas, Facilitator Petition Background/History Torre Taylor Technical Discussion (with 15 break)

All Decommissioning and Financial Assurance Requirements Roberto Torres Agreement State Information Michelle Beardsley Options for revising Part 30 Appendix B Torre Taylor; All Open Discussion and Questions All Summary and Next Steps Torre Taylor 4

  • Topic of Rulemaking

- Decommissioning financial assurance requirements for sealed and unsealed radioactive material

- Update to Appendix B/Part 30 to include radionuclides not listed

  • Focus of this meeting

- Discuss approaches for revising Appendix B/Part 30

- Seek public input

  • Status of rulemaking

- Developing the regulatory basis 5

  • Petition from Organization of Agreement States (OAS) in 2017
  • Rulemaking Plan to Commission - December 2019 (SECY-19-0125 )
  • Commission approved initiation of rulemaking

- Staff Requirements Memorandum October 2020 6

  • What is financial assurance and how is it determined?
  • NRC regulations for financial assurance
  • Examples for when decommissioning financial assurance funding plan is needed 7
  • A guarantee, or other financial arrangement, provided by a licensee that ensures funds for decommissioning will be available when needed. This is in addition to the licensees regulatory obligation to decommission its facilities.

8

  • Two criteria:

- Radioactive material must have a half life greater than 120 days; AND

- Licensee must possess it in a quantity greater than the applicable activity threshold in Section 30.35(d) for material in sealed or unsealed form.

9

  • By using the tables in 10 CFR 30.35(d) - Tables set forth fixed monetary amounts based on order-of-magnitude multiples of the applicable radionuclide values in Appendix B.
  • To find the decommissioning funding required, the licensee/regulator compares the licenses possession limit for the specific nuclide to the nearest applicable order of magnitude exceeding that possession limit.

10 10 10 10

Greater than 104 but less than or equal to 105 times the applicable quantities of Appendix B to Part 30 in unsealed form.

$1,125,000 Greater than 103 but less than or equal to 104 times the applicable quantities of Appendix B to Part 30 in unsealed form.

$225,000 Greater than 1010 but less than or equal to 1012 times the applicable quantities of Appendix B to Part 30 in sealed sources or plated foils.

$113,000 11

Material Microcuries Americium-241

.01 Carbon-14 100 Cesium-137 10 Cobalt-60 1

Hydrogen-3 1,000 Any alpha emitting 0.01 Any radionuclide other than alpha emitting radionuclides 0.1 12

100 mCi No financial assurance needed 1 Ci

$225,000

$1,125,000 Site specific decommissioning funding plan (DFP)

NUREG-1757, Volume 3, Rev. 1 No financial assurance needed 10,000 Ci

$113,000 1,000,000 Ci DFP C-14 Co-60 10 Ci Carbon-14 has a half-life of 5,730 years (greater than 120 days).

Cobalt-60 has a half-life of 5.3 years (greater than 120 days).

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0.1 mCi No financial assurance needed 1 mCi

$225,000

$1,125,000 Site specific decommissioning funding plan (DFP)

NUREG-1757, Volume 3, Rev. 1 Ge-68 10 mCi Germanium-68/Gallium-68 generator (100 mCi of Ge-68), used in medical diagnosis, would require a site-specific decommissioning funding plan.

Germanium-68 has a half life of 270.95 days (greater than 120 days).

14

0.1 mCi No financial assurance needed 1 mCi

$225,000

$1,125,000 Site specific decommissioning funding plan (DFP)

NUREG-1757, Volume 3, Rev. 1 Lu-177m 10 mCi Lutetium-177 (half life of 6.647 days), used in medical treatment, sometimes contains Lutetium-177m (half life of 161 days) that will require a site-specific decommissioning funding plan.

Lutetium-177m has a half life of 161 days (greater than 120 days).

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  • Agreement States are States that enter into an agreement with the NRC to maintain a program that is adequate to protect public health and safety, and the environment, and is compatible with the NRCs program
  • The regulations included in this rulemaking are a matter of both adequacy and compatibility with the Agreement States.

16

-Compatibility D: Not required for the purpose of compatibility; however, required for adequacy.

-Compatibility B: The State program element should be essentially identical to that of NRC.

17

Where do we go from here?

18

  • Alternative 1: Develop a new methodology based on risks and costs of decommissioning a facility where the subject radionuclide is used

- Apply to radionuclides already listed as well as the new additions

  • Alternative 2: Reconstitute Appendix B with values for labeling from Appendix C in 10 CFR Part 20 19

20 Pros Cons More risk informed possession values Likely to result in Appendix B values that are less conservative than Part 20 Appendix Cs labeling values Greater savings on decommissioning financial assurance costs for greatest number of affected licensees Longer rulemaking due to the need for developing new risk methodology Allows values to be set for unlisted nuclides with uses not now foreseen

21 Pros Cons Likely to result in more conservative Appendix B possession values compared to Alternative 1 Possession values for Appendix B radionuclides would be less risk-informed Sixty-seven radionuclides in Appendix B would increase 10-fold; another eleven would increase 100-fold: may result in the need for less decommissioning funding Likely to result in less decommissioning financial assurance cost savings compared to Alternative 1 Anticipate rulemaking taking less time to complete Will result in smaller Appendix B values for key radionuclides (e.g., Am-241, Cd-109k, Pu-239, U-233, U-234, U-235, Zr-93)

Add new category in Section 30.35 for radiopharmaceutical generators

- More engineered confinement than unsealed material but less than sealed sources

- Typically returned to an M&D

- Typically no need for extensive site decontamination or decommissioning 22

To comment, press *1 on your phone and wait for the operators instructions

Decommissioning Financial Assurance Requirements Public Meeting 15 minute Break

1. Is it a higher priority to update Appendix B with Appendix C/Part 20 values versus developing a new risk-methodology based on decommissioning risk?
2. If we develop a new risk-methodology, what factors should we consider in setting values for radionuclides?
3. Would a 10-fold reduction in Appendix B values increase any licensees decommissioning funding requirement for americium-241, cadmium-109, plutonium-239, uranium-233,

-234, and -235, or zirconium-93?

25

4.

What other benefits would be gained using one alternative over the other (new risk methodology vs. using values in Appendix C/Part 20)?

5.

Is one option more resource intensive than the other for the Agreement States or for licensees?

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6. If we develop a new category in Section 30.35 for radiopharmaceutical generators, how should we define them?

- What factors should we consider in setting requirements for engineered confinement?

7. Are there other regulatory requirements (NRC, state, other Federal agencies) that we need to consider?
8. What costs/benefits should be considered?

Information about types and number of licensees; number of administrations per year, etc.

27

  • Develop regulatory basis

- Evaluate input from public meeting

  • Sixty day public comment period

- Notice in the Federal Register - December 2021

  • Follow rulemaking in www.regulations.gov under Docket ID: NRC-2017-0031 28

Torre Taylor, Sr. Project Manager Division of Rulemaking, Environmental, and Financial Support Rulemaking Project Manager 301-415-7900 Torre.Taylor@nrc.gov Cardelia Maupin, Sr. Project Manager Division of Decommissioning, Uranium Recovery and Waste Programs Technical Lead 301-415-4127 Cardelia.Maupin@nrc.gov 29

  • Organization of Agreement State Petition; April 17, 2017 - ML17173A063
  • Federal Register notice closing petition

- 85 FR 75959; November 27, 2020 30

  • SECY-19-0125, Petition for Rulemaking and Rulemaking Plan on Decommissioning Financial Assurance Requirements for Sealed and Unsealed Radioactive Material (PRM 66; NRC-2017-0159); December 17, 2019 (ML18292A434)

References for Agreement State Information and Compatibility

  • Agreement State Program Policy Statement, dated October 18, 2017 (82 FR 48535)
  • Energy Policy Act of 2005, H.R. 6, 109th Cong.

(2005) 33

OAS Petition 34

Regulatory burden on Germanium-68 generators Small, enclosed, lead-lined. Contain a solid resin column with 50-100 mCi of insoluble Ge-68 (T1/2 271 days), which decays to Gallium-68 (T1/2 68 mins.)

FDA-approved for diagnostic imaging of neuroendocrine tumors (e.g.,

liver and pancreatic cancers)

- Significantly higher resolution permits much earlier detection and surgical excision of tumors;

- Nearly five-fold reduction in patient dose compared to In-111 technology.

Generators are typically returned to the manufacturer/distributor when depleted, typically every 12 months Citing costs of the DFP requirement, only a few major medical centers and radiopharmacies provide Ge-68 technology.

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Radionuclides with Half-Lives Greater Than 120 Days Proposed by Commenters for Listing in Appendix B Radionuclides Specifically Proposed By Commenters for Listing in Part 30 Appendix B Listed in Part 20 Appendix C?

Actinium-227 Yes (0.001 microcuries)

Aluminum-26 Yes (10 microcuries)

Cobalt-57 Yes (100 microcuries)

Germanium-68 Yes (10 microcuries)

Lutetium-177m Yes (10 microcuries)

Sodium-22 Yes (10 microcuries)

Rhenium-184m Yes (10 microcuries)

Silicon-32 Yes (1 microcurie)

Thorium-228 Yes (0.001 microcuries)

Titanium-44 Yes (1 microcurie) 36

CURRENT NRC REGULATIONS Decommissioning Funding Requirements 37

  • Under § 30.35:

- Possessing an unsealed radionuclide in a quantity more than 1,000 times the Appendix B value requires decommissioning financial assurance;

- Possessing an unsealed quantity greater than 100,000 times the Appendix B value requires a decommissioning funding plan (DFP);

- DFPs require a comprehensive decommissioning cost estimate and updates every three years;

  • May not be necessary for licensees using small quantities in engineered containers returned to manufacturer/distributor (M&D) after use.

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Appendix B possession values are used with 10 CFR 30.35 to determine how much decommissioning funding a licensee must provide to possess a given radionuclide in a sealed or unsealed form.

Section 30.35 sets forth tables requiring fixed amounts of decommissioning funding that increase with the quantity of a nuclide the licensee is allowed to possess.

The smaller the Appendix B value for a radionuclide, the less of it the licensee is allowed to possess without having to provide decommissioning financial assurance.

A licensee with a radionuclide not listed on Appendix B must use a very restrictive default value to determine the decommissioning funding amount required to possess the unlisted nuclide at the limit allowed by the license.

Material possessed in a sealed form requires much less financial assurance. Most medical uses require material in an unsealed form.

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If the licenses possession limit exceeds the quantity for which Section 30.35 prescribes the maximum $1,125,000 fixed amount of financial assurance, the licensee must submit a decommissioning funding plan (DFP) based on the expected actual cost of decommissioning. DFPs

- Must provide an amount of financial assurance based on a comprehensive estimate of the cost of decommissioning a facility using the maximum quantity allowed by the license;

- Must cover all nuclides used at a facility, even if none of the other nuclides would otherwise require decommissioning funding;

- May not be necessary for licensees using small quantities in engineered containers returned to manufacturer/distributor (M&D) after use.

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AGREEMENT STATE COMPATIBILTY CATEGORIES 41

A B

C State regulation needs to be identical State regulation needs to be essentially identical State regulation needs to meet essential objective of regulation D

H&S NRC Not required compatibility Needs to meet health and safety objective States cannot adopt regulations 42

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