Annette L. Vietti Cook Secretary US Nuclear Regulatory Commission Washington, DC 20555 0001 Attn: Rulemakings and Adjudications Staff Re: Medical Use of Byproduct Material Medical Event Definitions, Training and Experience, and Clarifying Amendments (Docket No. NRC 2008 0175) [Federal Register, Vol. 79, No. 139], and Draft Guidance (Docket No. NRC 2014 0030) [Federal Register, Vol. 79, No. 139] Dear Ms. Vietti Cook: The American Society for Radiation Oncology (ASTRO) applauds the Nuclear Regulatory Commission s proposed rule and accompanying draft guidance document for the Medical Use of Byproduct Material, and we appreciate the opportunity to provide comments. In particular, we appreciate and praise the NRC s demonstration of transparency and stakeholder engagement, including soliciting input from medical specialty societies and the NRC s Advisory Committee on the Medical Use of Isotopes (ACMUI) during the development of the proposed rule. ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with radiation therapy. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. ASTRO s highest priority has always been ensuring patients receive the safest, most effective treatments. Medical Event Criteria for Permanent Implant Brachytherapy ( 35.3045) ASTRO is pleased that the NRC has included medical event criteria specific to permanent implant brachytherapy. Under the current Part 35 section 35.3045, a medical event has occurred if the total dose delivered differs from the prescribed dose by 20 percent or more. ASTRO, as well as the ACMUI, believes that the current rule is not appropriate for permanent implant brachytherapy, as it identifies many medically acceptable and appropriate implants as medical events. This policy has created a chilling effect on the use of permanent implant brachytherapy, resulting in unnecessary patient and physician apprehension. The revised criteria for permanent implant brachytherapy in the proposed rule says that a medical event has occurred if the total source strength administered differs by 20 percent or more from the total source strength documented in the post implantation portion of the written directive. ASTRO agrees with this proposal, and we are pleased that the NRC has moved from a dose based definition to a source strength definition for permanent implant brachytherapy. This change is consistent with ASTRO and ACMUI recommendations and will ensure that medically acceptable and appropriate implants are not considered medical events. We believe this change will have a beneficial impact on patient access to care by encouraging physicians to continue offering this safe and cost effective procedure.
Page 2 However, ASTRO believes that the Commission has omitted a very important exception for causes outside of the physician s control. In particular, the ACMUI recommended, consistent with the Interim Enforcement Policy issued on July 30, 2013, that the medical event definition allow exceptions for seed migration and other patient related causes that are outside of the physician s control. The proposed revised definition did not include these important exceptions, and ASTRO recommends the following correction (addition bolded and underlined): 35.3045(a)(2) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (not resulting from patient related or procedure related causes such as edema, source migration after placement or imaging uncertainties) that results in We do not believe that the exception found in 35.3045(a) A licensee shall report as a medical event any administration requiring a written directive, except for an event that results from patient intervention, in which is sufficient to cover those patient or procedure related causes outside of the physician s control. In addition, we believe that the term patient intervention only covers events caused by a patient refusing treatment or cancelling an appointment. However, permanent implant brachytherapy for prostate cancer represents an important example of why an exception for procedure related causes is also necessary. As the Commission is aware, permanent implant brachytherapy for prostate cancer is a dynamic procedure often impacted by frequent, unpredictable changes in the prostate s size and shape, as well as the imaging modalities used. Prior to the procedure, ultrasound is used to determine the size and shape of the prostate. Using this image, the physician will determine the treatment site (or target). The treatment site generally will include a small fraction of space outside of the actual prostate as most prostate tumors are found in the periphery of the prostate. Because the structure of the prostate may change during the procedure, or even after the initial planning ultrasound, the authorized user may make changes to the number of seeds used or the placement of those seeds. Likewise, a prostate implant seed may migrate outside of the prostate itself. Just as the changing shape and size of the prostate is out of the physician s control, seed migration is a common unintended procedure related event that poses no risk for the patient. It is important that the Commission not consider such patientrelated events or procedure related events outside of the physician s control as medical events. Regulations in this area must allow for flexibility during the procedure for these patient related and procedure related causes and clinically necessary changes. ASTRO again urges the Commission to include the exception for patient related and procedure related causes in the definition of medical event for permanent implant brachytherapy. Without this exception, we are concerned that many medically acceptable procedures will be labeled as medical events, contrary to our understanding of NRC s intent. Additional Medical Event Criteria for Permanent Implant Brachytherapy ASTRO believes that most of the additional medical event criteria found in 35.3045(a)(2)(v) are reasonable and will avoid unnecessary reporting. However, we do have concern with 35.3045(a)(2)(v)(C) Sealed source(s) directly delivered to the wrong treatment site. We believe that this criteria is unclear and could cause unnecessary confusion and reporting. As written, this criteria would categorize even one migrated seed to a location just beyond the treatment site, a common
Page 3 occurrence in well done implants, as a medical event. We do not believe that the Commission intended for one migrating seed to constitute a medical event. Rather, we believe the Commission intended to categorize as medical events the implantation of seeds into the wrong organ or anatomical site than what was in the pre implant written directive. For example, if the pre implant written directive states that the seeds are to be implanted into the right breast, but upon post implant imaging, it is found that the seeds were implanted into the left breast, this would constitute a medical event. ASTRO therefore recommends that the Commission revise this criteria as follows (revision bolded and underlined): 35.3045(a)(2)(v)(C) Sealed source(s) directly delivered to a non contiguous the wrong treatment site. Yttrium 90 (Y 90) Microspheres. ASTRO is concerned about confusion among authorized users surrounding the definition of medical event and written directives related to Y 90 microspheres. The licensing guidance (dated June 2012) for Y 90 microspheres describes them as manual brachytherapy sources used for permanent implantation therapy. By using this description, we believe Y 90 microspheres are subject to the same requirements as other permanent implant brachytherapy procedures. However, the licensing guidance for Y 90 microspheres specifically refers to dose and not activity, and it contains different criteria for medical events and written directives than the proposed rule for permanent implant brachytherapy. While we understand the need for separate guidance for those sealed sources and devices licensed under 35.1000, and that this guidance supersedes what is found in the regulations (and in the proposed rule), we believe that the Commission must clarify this distinction to avoid any confusion by licensees. Compatibility Category for Report and Notification of a Medical Event ( 35.3405) ASTRO applauds the Commission s decision to move 35.3405 from Compatibility Category C to Compatibility Category B. Currently, 35.3405, Report and Notification of a Medical Event, is designated as Compatibility Category C for the Agreement States. This means that the Agreement States must adopt the essential objectives of the requirement to avoid conflicts, duplications, or gaps. Provided that the essential objectives are met, the manner in which they are addressed by the Agreement States may be different than the NRC requirements. A Compatibility Category C designation also means that Agreement States may require the reporting of medical events with more restrictive criteria than those required by the NRC. As the NRC noted in the proposed rule, some medical licensees practice at multiple locations, some of which are NRC regulated and some of which are Agreement State regulated. A Compatibility Category B designation would allow for uniformity of practice and procedures across the country. Compatibility Category B designations are for those program elements that apply to activities that have direct and significant effects in multiple jurisdictions. Moving 35.3405 from Compatibility Category C to B is appropriate and necessary. However, to make the move from Compatibility Category C to B smooth, the NRC should define the essential objectives of 35.3405 such that the Agreement States adoption of the new definition are not met with unnecessary delays. ASTRO recognizes that the Agreement States oppose a change in compatibility level, citing state legislative requirements, the difficulty in changing state regulations, and the fact that they do not perceive a problem with the current dose based definition. While we appreciate these concerns, we believe they are outweighed by the importance of having a consistent definition throughout the country
Page 4 to prevent confusion and unnecessary reporting of otherwise medically acceptable events. We remain concerned that a Compatibility C designation would allow Agreement States to implement unnecessarily more restrictive definitions that classify medically acceptable procedures as medical events, which we believe is contrary to the intent of the NRC in rewriting the definition and in changing the compatibility level. Written Directives for Permanent Implant Brachytherapy ( 35.40(b)(6)) ASTRO is pleased that the Commission has included requirements for a pre implantation written directive and a post implantation written directive for permanent implant brachytherapy. As noted above, it is important that the physician have the ability to make changes to their plan during the procedure, especially when changes outside of the physician s control medically necessitate a change to what was outlined in the written directive. These changes are medically necessarily and should not constitute a medical event. We do not believe that the addition of a post implant written directive will impact patient care or the delivery of these treatments. Procedures for Administrations Requiring a Written Directive ( 35.41) 35.41 requires licensees to have written procedures for administrations requiring a written directive. Specifically, 35.41(b)(6) states that a licensee must have a written procedure for: Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed unless accompanied by a written justification related to patient unavailability: (i) The total source strength administered outside of the treatment site compared to the total source strength documented in the postimplantation portion of the written directive; (ii) The absorbed dose to the maximally exposed 5 contiguous cubic centimeters of normal tissue located outside of the treatment site; and (iii) The absorbed dose to the maximally exposed 5 contiguous cubic centimeters of normal tissue located within the treatment site. To make these determinations, post implant dosimetry must be performed, generally using CT. However, patient unavailability may not be the only reason post implant imaging is not performed. For example, a machine may be broken and the facility may not have a backup, or the facility may have lost electricity because of a storm. We believe that the requirements set forth in this section are reasonable, and appropriately recognize that the licensee must keep records that may be referenced during an inspection and are not considered to be part of the criteria for a medical event. However, we believe that it is necessary to detail other reasons why post implant imaging did not occur. Therefore, we suggest the following change (addition bolded and underlined): 35.41(b)(6) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed unless accompanied by a written justification related to patient unavailability or circumstances not within the control of the facility.
Page 5 Extending Grandfathering to Certain Certified Individuals ( 35.57) and Preceptor Attestation Requirements ASTRO is pleased that the proposed rule will amend 35.57 to recognize Radiation Safety Officers (RSOs), teletherapy or medical physicists, Authorized Medical Physicists (AMPs), Authorized Users (AUs), nuclear pharmacists, and Authorized Nuclear Pharmacists (ANPs) for the modalities that they practiced as of October 24, 2005. This change is in response to the American Association of Physicists in Medicine s (AAPM) petition (PRM 35 20, published in the Federal Register November 1, 2006) requesting that experienced board certified RSOs and medical physicists not named on a license who had practiced certain modalities prior to October 24, 2005, be exempted from the specific T&E requirements in 10 CFR 35.50, and 35.51, respectively. We do not believe that it was the intent of the NRC to deny recognition to any physician or medical physicist who was practicing as of October 24, 2005 or to minimize the importance of the certifying boards. We are pleased that the Commission believes that these individuals are eligible for grandfathering for the modalities that they practiced as of October 25, 2005, and that their previouslyacceptable qualifications for authorized status should continue to be adequate and acceptable from a health and safety standpoint such as to allow them to continue to practice using the same modalities. In addition, ASTRO commends the NRC for eliminating the requirement for preceptor attestations for all individuals certified by NRC recognized boards, including those grandfathered individuals as discussed above. We agree that attestations are not necessary in this particular situation because the provisions of 35.59, Recentness of training, require that the training and experience (T&E) requirements must have been obtained within the 7 years preceding the date of application, or the individual must have had related continuing education and experience since the required T&E was completed. Allowing Associate Radiation Safety Officer (ARSO) to be Named on a Medical Use License ASTRO has no objections to naming ARSOs on a medical use license. We also support allowing ARSOs to serve as preceptors for those applying to be an RSO or an ARSO, and we believe this addition will enhance radiation safety programs. Ophthalmic Physicist ASTRO disagrees that sufficient need exists to create an ophthalmic physicist designation. The Draft Guidance provides further explanation for this new designation stating that: After implementation of the 2002 rule [requiring an AMP for strontium 90 procedures], the NRC determined that there were a number of small ophthalmic therapy licensees in rural or isolated areas that had difficulty finding a local AMP. Therefore, the ophthalmic physicist has been added to identify another individual that could perform the medical physics tasks associated with ensuring that the ophthalmic therapies were administered in accordance with the written directives. ASTRO is not convinced that this rationale is sufficient enough to establish a separate designation for an ophthalmic physicist, nor has NRC demonstrated sufficient need for such a designation. We are concerned that by designating a physicist for one specific application (in this case strontium 90), the NRC will set a precedent for other sourcespecific designations, rendering the AMP obsolete.
Page 6 Conclusion ASTRO generally is very pleased with the proposed rule and the accompanying draft guidance documents and believes that the proposed changes will positively impact clinical practice. We are grateful for the diligent and inclusive work of NRC Commissioners and staff. ASTRO appreciates the opportunity to provide comments on the proposed rule for the Medical Use of Byproduct Material. We look forward to continuing to work with the NRC on these important issues. Please contact Cindy Tomlinson, Senior Manager for Security and Safety, at 703.839.7366 or cindyt@astro.org if you have any questions. Sincerely, Laura I. Thevenot Chief Executive Officer