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RULEMAKING ISSUE
NOTATION VOTE

SECY-08-0080

June 6 , 2008

• PURPOSE
• BACKGROUND
• DISCUSSION
• AGREEMENT STATE ISSUES
• RECOMMENDATIONS
• RESOURCES
• COORDINATION

PURPOSE:

To request Commission approval to publish a proposed rule, in the Federal Register, that would amend 10 CFR Part 35.  The proposed amendments would revise 10 CFR 35.40 and 35.3045 that govern medical use of byproduct material related to reporting and notifications of medical events (MEs) to clarify requirements for permanent implant brachytherapy.  This paper does not address any new commitments.

BACKGROUND:

Several medical use events involving therapeutic use of byproduct material in 2003, as well as advice from the Advisory Committee on the Medical Use of Isotopes (ACMUI), prompted the reconsideration of the appropriateness and adequacy of the regulations regarding MEs and written directives (WDs).  On March 16, 2004, the Commission issued a Staff Requirements Memorandum (SRM) - M04032B (ADAMS accession number ML040760566) directing the staff to provide the Commission with recommendations concerning the current definition of medical events.  The SRM recommended that the staff involve ACMUI in the development of these recommendations.

On December 27, 2005, the U.S. Nuclear Regulatory Commission (NRC) staff requested Commission approval to develop ACMUI recommendations into a proposed rule in SECY-05-0234 (ML053180408) and approve the staff's plan to revise the ME definition and the associated requirements for WDs to be activity-based instead of dose-based.  On February 15, 2006, the Commission issued SRM-SECY-05-0234 (ML060460594) directing the staff to forgo the development of a rulemaking plan, to proceed directly with developing a proposed rule to modify the WD requirements in 10 CFR 35.40 and ME reporting requirements in 10 CFR 35.3045 for permanent implant brachytherapy to convert from dose-based to activity-based, and to solicit public input on the drafting of the proposed rule.

A working group was formed and drafted the proposed rule language.  Public input on the preliminary draft rule language was solicited via regulations.gov (Docket ID # NRC-2008-0071) on February 8, 2008, and noticed in the Federal Register on February 15, 2008 (73 FR 8830).  Additionally, the preliminary draft rule language and information on how to provide input was sent out on the NRC's Medical List Server on February 8, 2008.  Public input on the suggested language resulted in revising the proposed language related to information required on the preimplantation WD and in other clarifications of the proposed regulation.

DISCUSSION:

In accordance with SRM-SECY-05-0234, the NRC staff has developed a proposed rule (Enclosure ) based in part upon recommendations from ACMUI and upon recommendations from NRC's Medical Radiation Safety Team.  The proposed rule would amend the current regulations by changing the criteria for defining an ME for permanent implant brachytherapy from dose-based to activity-based; adding a requirement to report, as an ME, any administration requiring a WD if a WD was not prepared; clarifying requirements for WDs for permanent implant brachytherapy; and making certain administrative and clarification changes.  The proposed rule would modify 10 CFR 35.40 and 35.3045 to establish separate ME criteria and WD requirements for permanent implant brachytherapy.  The proposed rule would facilitate the ability of medical licensees to recognize MEs in permanent implant brachytherapy earlier and therefore be able to take corrective actions sooner than under current regulations.

The proposed rule supports NRC's 2008-2013 Strategic Plan in the areas of safety and operational excellence.  In the area of safety, the proposed rule supports the NRC Safety Goal (develop, maintain, and implement licensing and regulatory programs for materials users to ensure the adequate protection of health and safety) by facilitating the ability of medical licensees to recognize MEs in permanent implant brachytherapy earlier and therefore be able to take corrective actions sooner.  Taking prompt corrective actions based on ME findings increases the health and safety of patients.

In the area of operational excellence, the proposed rule supports the objective of openness.  Specifically, soliciting input from the public on the preliminary draft language supports openness strategy 3 (providing for fair, timely, and meaningful stakeholder involvement in NRC decision making), and strategy 5 (initiating early communication with stakeholder on issues of substantial interest).

AGREEMENT STATE ISSUES:

A copy of the draft proposed rule Federal Register notice was provided to the Agreement States on April 27, 2008, for a 30-day comment period, to afford them an early opportunity for review.

Two Agreement States, Washington and New York, provided comments on the draft Federal Register notice.  Washington State noted that a WD was discussed in relation to 10 CFR 35.100 and 35.200 when these sections are related to diagnostic use of byproduct material not requiring a WD, expressed concern regarding the removal of certain language from the rule, and appeared to question the need for an authorized user's (AU's) signature after administration.  New York State suggested that the proposed activity-based criteria for determining if an ME occurred should be in addition to the existing dose-based criteria.

These comments were considered by the staff and the supplementary information accompanying the proposed rule was revised as necessary to clarify the changes that are being proposed in the rule.  However, the suggestion that the dose-based criteria be retained was not adopted since the Commission in SRM-SECY-05-0234, dated February 15, 2006, specifically directed the staff to convert from a dose-based to activity-based criteria.

The NRC staff has analyzed the proposed rule in accordance with the procedures established within Part III of the Handbook to Management Directive 5.9, "Categorization Process for NRC Program Elements."  The staff has determined that, in accordance with these procedures, § 35.3045 of the proposed rule is classified as Compatibility Category "C" (those that do not meet Category "A" or "B" and the essential objective should be adopted by the state to avoid conflict, duplication, gaps, or other conditions that would jeopardize the orderly pattern in the regulation of agreement material on a nationwide basis), § 35.40(c) of the proposed rule is classified as Compatibility Category AD" (those that do not meet Categories "A", "B" or "C" and thus do not need to be adopted by the state), and § 35.40(b), is classified as Compatibility Category Health and Safety (identifies programs elements that are not required for purposes of compatibility, but have particular health and safety significance).

RECOMMENDATIONS:

That the Commission:

1. Approve for publication, in the Federal Register, the proposed amendments to Part 35 (Enclosure ).

2. Note that:

1. The proposed amendments will be published in the Federal Register, allowing 75 days for public comment.

2. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification and the reasons for it, as required by the Regulatory Flexibility Act, 5 U.S.C. 605(b).

3. A draft Regulatory Analysis has been prepared for this rulemaking and is included within the proposed rule.

4. Appropriate Congressional committees will be informed of this action.

5. A press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register.

6. Office of Management and Budget (OMB) review is required and a clearance package will be forwarded to OMB no later than the date the proposed rule is submitted to the Office of the Federal Register for publication.

RESOURCES:

To complete and implement the rulemaking, 0.8 full-time equivalent (FTE) positions will be required for fiscal year 2008 and 0.5 FTE positions for fiscal year 2009.  These resources are included in the current budget.

COORDINATION:

The Office of the General Counsel has no legal objection to the proposed rulemaking.  The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no objections.  The rule proposes changes in information collection requirements that must be submitted to OMB no later than the date the proposed rule is forwarded to the Federal Register for publication.

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Tuesday, June 24, 2008