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

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a proposed rule to revise certain sections in 10 CFR Parts 30, 32, and 35, as well as a notice of availability of the draft guidance to go with these proposed changes.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 Comment form for the proposed rule can be found here and the comment form for the draft guidance document can be found here.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

The proposed rule would establish separate requirements for identifying and reporting medical events (ME) involving permanent implant brachytherapy programs. These new regulations would require reporting of an event in which there is actual or potential harm to a patient resulting from an ME. Additionally, licensees would be required to develop, implement, and maintain procedures for determining if an ME has occurred, including, for permanent implant brachytherapy, procedures for making certain assessments within 60 days from the date the treatment was performed;
The NRC or an Agreement State would amend Training and experience requirements in multiple sections to remove the requirement to obtain a written attestation for an individual who is certified by a specialty board whose certification process has been recognized. This requirement is being removed because the NRC has determined that certification by a specialty board, coupled with meeting the recentness of training requirements, is sufficient to demonstrate that an individual seeking authorization on a license has met the training and experience (T&E) requirements and has the requisite current knowledge and that additional attestation by a preceptor is therefore unnecessary. Individuals who are not board certified would still need to obtain a written attestation; however, the language of the attestation would be modified. Additionally, residency program directors would be able to provide these written attestations;
The requirements for measuring the Mo-99 concentration for elutions of Mo-99m/Tc generators would be changed and reporting requirements added for failed Mo-99/Tc-99m and strontium-82 (Sr-82)/Rb-82 generators. The current requirement to measure the Mo-99 concentration after the first eluate would be changed to require that the Mo-99 concentration be measured in each eluate because of several incidents reported to the NRC of breakthrough; and
Licensees would be allowed to appoint a qualified individual with expertise in certain uses of byproduct material to be named on a license to serve as an Associate Radiation Safety Officer (ARSO). This would make it easier for an individual to become a Radiation Safety Officer (RSO) on other medical licenses and would increase the number of individuals who would be available to serve as preceptors for individuals seeking to be appointed as RSOs or ARSOs.

Specifics on the Medical Event Definition for Permanent Implant Brachytherapy

The proposed ME criteria are primarily source-strength based for the treatment site, and dose-based for the absorbed dose to normal tissues. The proposed ME criteria for permanent implant brachytherapy are:
1. For the treatment site (documented in the pre-implantation portion of the written directive (WD)), an ME has occurred if 20 percent or more of the implanted sources documented in the post-implantation portion of the WD are located outside of the intended implant location. In supporting this recommendation, the NRC believes that source strength/positioning is the measurable metric/surrogate for dose, as related to harm/potential harm for permanent brachytherapy implant MEs. The 20 percent variance limit (from physician intention) is consistent with the recommendation of the Advisory Committee on Medical Uses of Isotopes (ACMUI) for all medical uses of byproduct material as described in SECY-05-0234.
2. For normal-tissue structures, an ME has occurred if: (a) For structures located outside of the treatment site (for example the bladder or rectum for prostate implant treatments), the dose to the maximally exposed 5 contiguous cubic centimeters of tissue exceeds 150 percent of the absorbed dose prescribed to the treatment site in the pre-implantation portion of the WD; or (b) for intra-target normal structures, the maximum absorbed dose to any 5 contiguous cubic centimeters of tissue exceeds 150 percent of the dose the tissue would have received based on the approved pre-implant dose distribution.
  
  The size of the normal tissue, 5 cubic centimeters, is based on ACMUI's recommendation in its report. In its recommendation, the ACMUI stated that the 5 contiguous cubic centimeters dose-volume specification avoids the high variation in dose sometimes seen in point doses and has cited literature to support that as being a relevant quantity for toxicity. In this proposed rule, the NRC is specifically inviting comments on the selection of the specified volume of the normal tissues located both outside and within the treatment site in defining MEs.
  
  The proposed rule specifies that these dose determinations must be made within 60 days from the date the treatment was administered unless accompanied by written justification about patient unavailability after treatment. The NRC believes that 60 days provides adequate time to make implanted source location and dose assessments to determine if an ME has occurred. The AAPM, in its Task Group Report 137, entitled, “AAPM recommendations on dose prescription and reporting methods for permanent interstitial brachytherapy for prostate cancer,” recommends that post-implant dosimetry for iodine-125 implants should be performed at 1 month (plus or minus 1 week) after the procedure. For palladium-103 and cesium-131 implants, it recommends that post-implant dosimetry be performed at 16 (plus or minus 4) days and 10 (plus or minus 2) days, respectively. The 60-day time limit is also consistent with the ACMUI recommendation. The NRC recognizes that some patients may not be able to return to the treatment center for the dose assessment, and the proposed rule addresses that concern by adding “unless accompanied by written justification about patient unavailability.”
  
  Because of this dose-based ME criterion for organs and tissues other than the treatment site, there is an implicit operational requirement for post-implant imaging, as strongly recommended during the public workshops and as practiced in most clinical facilities.
3. An ME has occurred if a treatment involves: (a) Using the wrong radionuclide; (b) delivery to the wrong patient or human research subject; (c) source(s) implanted directly into the wrong site or body part, i.e., not in the treatment site identified in the WD; (d) using leaking sources; or (e) a 20 percent or more error in calculating the total source strength documented in the pre-implantation WD (plus or minus 20 percent is used for the ME threshold for source strength variance because plus or minus 10 percent is considered too close to the actual variance associated with this quantity in clinically acceptable implant procedures).
  
  The proposed criterion related to sources implanted directly into the wrong site or body part (i.e., not in the treatment site identified in the WD) directly reflects an ACMUI recommendation. Note that the proposed criterion would require that even a single sealed source directly delivered to the wrong treatment site would constitute an ME that must be reported. However, this proposed criterion is not more restrictive than the current regulation, which requires reporting of a dose of 0.5 sievert (50 rem) to an organ or tissue, since the localized dose associated with even one misplaced source would far exceed the current 0.5 sievert (50 rem) dose threshold.
  
  The current WD requirements for manual brachytherapy in § 35.40(b)(6) primarily reflect requirements associated with temporary implant brachytherapy medical use. The WD requirements in § 35.40 would be amended to establish separate WD requirements appropriate for permanent implant brachytherapy. The WD for permanent implant brachytherapy would consist of two portions: The first portion of the WD would be prepared before the implantation, and the second portion of the WD would be completed after the procedure, but before the patient leaves the post-treatment recovery area. For permanent implant brachytherapy, the WD portion prepared before the implantation would require documentation of the treatment site, the radionuclide, the intended absorbed dose to the treatment site, and the corresponding calculated source strength to deliver that dose. If the treatment site has normal tissues located within it, the WD would also allow documentation of the expected absorbed dose to normal tissue as determined by the AU. The post-implantation portion of the WD would require the documentation of the number of sources implanted, the total source strength implanted, the signature of an AU for § 35.400 uses for manual brachytherapy, and the date. It would not require the documentation of dose to the treatment site.
  
  Based on ACMUI input and information gained at public workshops, the NRC understands that the final WD documentation related to these § 35.40 permanent implants must reflect the medical situation encountered during the surgical procedure. Therefore, in defining an ME involving the treatment site for permanent implants, the NRC based the criterion for an ME on the percentage of implanted sources that are outside the treatment site as documented in the post-implantation portion of the WD rather than defining an ME based on a comparison of the implanted total source strength to the calculated total source strength documented in the pre-implantation portion of the WD. This proposed definition differs from the ME definition for all other brachytherapy procedures where the dose comparisons are made with what was prescribed in the WD prepared/revised before the procedure.
  
  Conforming changes would be made to § 35.41, “Procedures for administrations requiring a written directive,” to include permanent implant brachytherapy. Although the current § 35.41(a)(2) requires licensees to determine if the administration is in accordance with the written directive, there is no specific requirement that a licensee determine that an administered dose or dosage has met an ME criterion defined in § 35.3045. The ME reporting criteria are defined in § 35.3045, but the current regulations do not require that a licensee have procedures to make that determination. Section 35.41 would be amended to require that a licensee include procedures for determining if an ME has occurred. For all permanent implant brachytherapy, this section would also be amended to require that a licensee develop additional procedures to include an evaluation of the placement of sources as documented in the completion portion of the WD, dose assessments to maximally exposed 5 contiguous cubic centimeters of normal tissue located both inside and outside of the treatment site, and to include that these assessments be made within 60 days from the date the treatment was performed.
  
  Currently § 35.3045, Report and notification of a medical event, is designated as Compatibility Category C for the Agreement States. Input provided at the public meetings conducted in New York City, New York, on June 20-21, 2011, and in Houston, Texas, on August 11-12, 2011, and from the ACMUI prompted the NRC to revisit compatibility category. The Commission, after considering the issue, is proposing that the compatibility for reporting MEs for the Agreement States be designated as a Compatibility Category B.

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

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.
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.
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.
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:

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.

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.
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.