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NRC Issues Proposed Rule and Guidance Document for 10 CFR Part 35 Medical Use Of Byproduct Material

On July 21, 2014, Nuclear Regulatory Commission (NRC) published in the Federal Register a proposed rule to revise certain sections in 10 CFR Parts 30, 32, and 35, as well as a notice of availability of the draft guidance to go with these proposed changes. The full guidance document can be found here. Comment form for the proposed rule can be found here and the comment form for the draft guidance document can be found here.

The proposed rule would amend the Commission's medical use regulations in part 35.

Major Provisions

Specifics on the Medical Event Definition for Permanent Implant Brachytherapy

What are the Issues the NRC is seeking Specific Comments On?

  1. Specific Comments on Medical Event Definition
    1. The NRC is seeking specific comments, in defining MEs, on the proposed volume of 5 contiguous cubic centimeters dose-volume specification for an absorbed dose to normal tissue located both outside and within the treatment site.
    2. The NRC is also seeking specific comments on whether the application of the proposed medical event definition for normal tissue based on the absorbed dose to the maximally exposed 5 contiguous cubic centimeters during permanent implant brachytherapy is appropriate for all potential treatment modalities, or whether it may result in unintended consequences for tissues or organs adjacent to the treatment site.
  2. Implementation Period.

    In Section IV.B of this document, the NRC is proposing the effective date of the final rule to be 180 days from the date it is published in the Federal Register. The NRC is seeking specific comments on whether a 180 day effective date for the final rule is sufficient to communicate the changes to all practitioners, revise procedures, train on them, and implement the changes.
  3. Impact on Clinical Practice.

    The NRC is seeking comments on whether any of the proposed changes in this rulemaking are likely to discourage licensees from using certain therapy options or otherwise adversely impact clinical practice, and if so, how.
  4. Compatibility Category for the Agreement States on § 35.3045, Report and notification of a medical event.

    Currently § 35.3045, Report and notification of a medical event, is designated as Compatibility Category C for the Agreement States. This designation means the essential objectives of the requirement should be adopted by the State to avoid conflicts, duplications, or gaps. The manner in which the essential objectives are addressed in the Agreement State requirements need not be the same as NRC requirements, provided the essential objectives are met. Under Compatibility Category C, Agreement States may require the reporting of MEs with more restrictive criteria than those required by the NRC.

    Some medical licensees have multiple locations, some of which are NRC-regulated and some which are Agreement State-regulated. These licensees would prefer a Compatibility Category B designation for uniformity of practice and procedures among their different locations. A Compatibility Category B designation is for those program elements that apply to activities that have direct and significant effects in multiple jurisdictions.

    The Organization of Agreement States (OAS) has expressed a strong desire to retain a dose-based ME reporting criterion for the treatment site if NRC regulations are revised to include source-strength based criteria for determining MEs for permanent implant brachytherapy. The OAS has no objection to the introduction of the source-strength based criteria, as long as the dose-based criteria can be retained by the Agreement States, which requires § 35.3045 to remain as Compatibility Category C. With a Compatibility Category C designation, the Agreement States could require both the dose-based criterion and source-strength based criterion, as long as the Agreement State reports to the NRC only include the information required by the NRC.

    For some Agreement States, Compatibility Category B is difficult to achieve because their regulations have to also meet specific state requirements based on the state agencies in which the radiation control regulators reside. Also, Agreement States may have existing laws requiring the collection of additional information on medical diagnostic and therapy procedures.

    If the level of compatibility for § 35.3045 were to be raised to Compatibility Category B, Agreement State requirements would need to be essentially identical to those of the NRC. Compatibility Category B is applied to requirements that have significant direct transboundary health and safety implications. A Compatibility Category B designation would prevent the Agreement State requirements from including any additional requirements, such as diagnostic reports, shorter reporting times, or lower dose limits for reporting.

    The ACMUI in its report to the NRC (ADAMS Accession No. ML13071A690), recommended that MEs related to permanent implant brachytherapy be designated as Compatibility Category B. The ACMUI was concerned with proposed designation as Compatibility Category C which would allow the Agreement States to retain the dose-based criteria for definition of an ME for permanent implant brachytherapy. The ACMUI asserted that a Compatibility Category C would continue to result in clinically insignificant occurrences being identified as MEs by Agreement States and thereby perpetuate the confusion associated with the current dose-based criteria. The ACMUI stated that the most important component of the rationale for conversion from dose-based to activity-based criteria is the failure of dose-based criteria to sensitively and to only specifically capture clinically significant MEs in permanent implant brachytherapy.

    Because of these divergent positions (the OAS favoring Compatibility Category C and some medical use licensees and the ACMUI favoring Compatibility Category B), the NRC invites comments on the appropriate compatibility category for ME reporting under § 35.3045.

As indicated in the Federal Register Notice you may submit comments by any of the following methods:

  1. Comments on both the Proposed Rule and Draft Guidance:
    • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2008–0175 [the proposed rule] or Docket ID NRC–2014–0030 [the draft guidance]. Address questions about NRC dockets to Carol Gallagher; telephone: 301–287–3422; email: Carol.Gallagher@nrc.gov.
  2. Additional comment methods for the Proposed Rule:
    • Email comments to: Rulemaking.Comments@nrc.gov. If you do not receive an automatic email reply confirming receipt, then contact us directly at 301–415–1677.
    • Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301–415–1101.
    • Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff.
    • Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301–415–1677.
  3. Additional comment method for the Draft Guidance:
    • Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch (RADB), Office of Administration, Mail Stop: 3WFN–06– A44MP, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.

Comments for both the proposed rule and its guidance to the NRC are due on November 18, 2014, however if you have comments that you want AAPM to consider, I will need all comments by October 15,2014 for AAPM reviews and finalization of AAPM’s comment letter.

Please send any comments for AAPM’s consideration to Lynne Fairobent, Senior Manager for Government Relations at lynne@aapm.org.