Status of Ongoing Rulemakings

OAS Annual MeetingAugust 29, 2012

Deborah Jackson, Deputy DirectorDivision of Intergovernmental Liaison

and Rulemaking

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Status of Rulemaking Activities• Part 35, Medical Rulemakings• Part 71 Transportation Rulemaking• Part 37, Physical Protection of

Byproduct Materials• SGI-M Rulemaking• Part 61, Site-Specific Assessment• General License Rulemaking• Other Rulemakings• Completed Rulemakings

Part 35 - Medical Rulemakings• Part 35 was revised in its entirety in

2002• Purpose of this rulemaking is to

address the issues in implementing the revised rule. Issues were identified by:

--NRC staff --The ACMUI, and --a petition for rulemaking

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Part 35 - Medical Rulemakings• Expanded Part 35 Amendments

• Training and experience (preceptor attestations)

• Grandfathering of certain certified individuals

• Increase frequency of measuring molybdenum tests in Mo-99/Tc-99m generators, and reporting of failed Tc-99m and strontium-82/rubidium-82 generators

• Naming Associate RSOs on a license • Medical Event Reporting

– Clarification of the definition of medical events for permanent implant brachytherapy

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Part 35 Rulemaking – Early Stakeholder Involvement • Posted preliminary rule text (non

controversial issues) in May 2011• Public workshops in June and August,

2011 discussed more controversial issues as well as the ME definition for permanent implant brachytherapy

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Part 35- Permanent Implant Inspection Procedure Guidance • A joint NRC/Agreement State WG

was formed in August 2011 to revise Permanent Implant Inspection Procedure

• The revised IP was provided to the Agreement States in April 2012

• Training was also provided to NRC/AS inspectors in April 2012

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Part 71 – Transportation• Objectives:

– Harmonize with International Standards– Maintain Consistency with U.S.

Department of Transportation Regulations

– NRC-Initiated Changes• Status

– Final Review and Approval

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Part 37 – Physical Protection of Byproduct Material Activities• Objective:

– Provide reasonable assurance of preventing the theft or diversion of category 1 and 2 quantities of radioactive material for malevolent use

• Commission affirmed final rule March 16

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SGI-M Rulemaking• Removes Safeguards Information –

Modified Handling (SGI-M) for– Panoramic and underwater irradiators– Manufacturers and distributors– Transportation of Category 1quantities

of radioactive materials

Part 61 - Site-Specific Analyses• Proposed Rulemaking for Limited-

Scope, Site-Specific Analyses – Objectives:

• Specify requirements for site-specific analyses to demonstrate compliance with the Part 61 performance objectives

• Will address disposal of large quantities of depleted uranium, blended waste, and other unique waste streams

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Part 61 - Site-Specific Analyses– On January 19, 2012, Commission issued

revised direction to the staff regarding:• ICRP dose methodologies• Compliance period and period of performance• Site-Specific Waste Acceptance Criteria• Agreement State compatibility

– Staff is currently revising the Regulatory Basis

– Proposed Rule now due to Commission July 2013

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General License Rulemakings• Final Rule - Source Material Generally

Licensed Devices (40.22)– Objective:

• Improve the control and distribution of source material under exemption and general license.

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Other Security Rulemakings• Security of Fuel Cycle Facilities• Security of Independent Spent Fuel

Storage Installations (ISFSIs)• Material Control and Accounting

(MC&A) Rule

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Other Ongoing Rulemakings• In-Situ Leach Uranium Recovery

(ISR) Groundwater Protection– Working with EPA

• Part 40 Integrated Safety Analysis (ISA)

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Completed Rulemakings• Exemptions and Distribution of

Byproduct Material (Parts 30, 31, 32, etc.)

• Advance Notification to Native American Tribes of Transport of Certain Types of Nuclear Waste

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