ML22203A072

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NRC Staff Presentation for Public Meeting Regarding Items Containing Biproduct Material Incidental to Production
ML22203A072
Person / Time
Issue date: 08/04/2022
From: Caylee Kenny
NRC/NMSS/DREFS
To:
Kenny C
References
10 CFR Part 30, 10 CFR Part 32, NRC-2015-0017, RIN 3150-AJ54
Download: ML22203A072 (21)
v • d • e


Text

Public Meeting on Proposed Rule:

Items Containing Byproduct Material Incidental to Production August 4, 2022 ADAMS Accession No. ML22203A072

Purpose

  • Provide information to help stakeholders prepare comments on the Items Containing Byproduct Material Incidental to Production proposed rule and draft regulatory guidance 2

Agenda

  • Welcome and Logistics
  • Opening Remarks
  • Background and Status
  • Overview of the Proposed Rule
  • Preparing Comments
  • Next Steps
  • Public Feedback and Questions 3

Logistics

  • Meeting is being recorded and transcribed
  • Keep line muted until you intend to speak

- Raise hand button in Teams // *5 on phone

- Unmute button in Teams // *6 on phone

  • Chat feature is disabled
  • Phone attendees should e-mail caylee.kenny@nrc.gov for attendance record 4

Opening Remarks Kevin Williams Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety & Safeguards (NMSS) 5

Background and Status

  • April 18, 2011 - GE Osmonics, Inc., submitted a petition for rulemaking (PRM), PRM-30-65
  • June 22, 2011 - NRC published a notice of docketing and request for public comment (76 FR 36386)
  • February 2, 2021 - NRC published a regulatory basis (86 FR 7819)
  • June 27, 2022 - The proposed rule was published (87 FR 38012).
  • September 12, 2022 - the 60-day comment period ends 6

Proposed Rule and Related Documents

- Web version

- Printed Version

  • Supporting & Related Material

- Draft Regulatory Analysis (ML22160A404)

- Draft Environmental Assessment (ML22160A406)

- Draft Supporting Statement for Information Collection (ML21256A288)

- Draft Supporting Guidance (ML21256A291) 7

Overview of the Proposed Rule

  • The NRC is proposing to amend its regulations by adding a new class exemption from licensing requirements to 10 CFR Part 30 and add associated distribution requirements to 10 CFR Part 32.
  • § 30.23 would establish requirements for the class exemption for ICBMIP
  • § 32.33 would establish requirements for the initial distributors of ICBMIP
  • § 32.34 would establish new safety criteria
  • § 32.35 would establish the specific conditions of the license issued under § 32.33
  • Would create a path for licensing current and future products that contain byproduct material incidental to their production.

8

Purpose of Proposed Rule These proposed changes would:

  • Apply dose criteria, rather than concentration, as the primary means of protecting health and safety;
  • Fully address PRM-30-65;
  • Provide a regulatory framework for current ( i.e.,

gemstones) and future irradiated products; 9

Purpose of Proposed Rule These proposed changes would:

  • Allow this class of products to be licensed without product-specific exemptions, which would otherwise require additional rulemaking in the future; and
  • Require a licensee to meet dose-based criteria, which would reduce the regulatory costs for current gemstone licensees, who currently provide both concentration and dose-based criteria.

10

Regulatory Analysis

  • Rulemaking and guidance development would be cost beneficial to the industry and the Government, but not to the Agreement States
  • Total net overall savings of $13,071,000
  • $3,219,000 benefit to industry
  • $11,313,000 benefit to the NRC
  • ($1,460,000) to Agreement States
  • NRC would issue the exempt distribution licenses, the Agreement States would issue the underlying required possession license, accounting for the cost to Agreement States that would result from this rule 11

Regulatory Analysis Qualitative Benefits -

  • Addresses the regulatory gap for ICBMIP
  • Saves resources in the long term because case by case reviews would not be needed for each new technology
  • Supports the development of future products that may be included in this regulatory space
  • Resolves the long-standing issue with the regulatory approach for gemstones
  • Reduces the regulatory burden on the licensees by requiring only dose criteria rather than both dose and concentration criteria 12

Preparing Comments Review the Commenters Checklist on Regulations.gov

  • Available on the comment submission form on Regulations.gov
  • Also available in printable format 14

How to submit a comment Regulations.gov: comment form or Email:

Rulemaking.Comments@nrc.gov or Mail:

Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemakings and Adjudications Staff 15

Where to Find Information Go to https://www.regulations.gov and search for docket ID NRC-2015-0017 16

Next Steps

  • Public Comment Period ends: September 12, 2022
  • Review and develop responses to public comments as part of final rule 17

Public Feedback and Questions How did we do?

  • NRC Public Meeting Feedback form (QR code):
  • The public meeting feedback form can also be accessed on the meeting details page:

https://www.nrc.gov/pmns/mtg?do=details&Code=20220731 19

References

  • 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)
  • Presidential Memorandum, Plain Language in Government Writing,(63 FR 31885; June 10, 1998)
  • FRN for PRM-30-65 Receipt and Request for Comment [NRC-2011-0134] (76 FR 36386; published June 22, 2011)
  • GE OsomicsPolymer Track Etch Membrane 10 CFR 32.1Manufacture and Distribution Product Safety Information, March 20, 2012 (ADAMS Accession No. ML120800277)
  • FRN for PRM-30-65 Docket Closure [NRC-2011-0134] (77 FR 56793; September 14, 2012)
  • NRC Agreement State Program Policy Statement (82 FR 48535; October 18, 2017)
  • Draft Guidance Document to NUREG-1556, Volume 8, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses, dated June 2022 (ADAMS Accession No. ML21256A291)

Acronyms ADAMS Agencywide Documents Access and Management System CFR Code of Federal Regulations FRN Federal Register Notice ICBMIP items containing byproduct material incidental to production NMSS Office of Nuclear Material Safety and Safeguards NPV net present value NRC Nuclear Regulatory Commission PRM Petition for Rulemaking SECY Document from the NRC staff to inform or seek decision from the Commission SRM Staff Requirements Memorandum 21

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