ML18242A169

Federal Register Notice Final Rule Part 35

ML18242A169
Person / Time
Issue date:	07/16/2018
From:	Kimyata Morgan-Butler Office of Nuclear Material Safety and Safeguards
To:
Howe D
Shared Package
ML18242A168	List: ML18242A169 ML18242A174
References
83FR33046, NRC-2008-0175, RIN 3150-A163
Download: ML18242A169 (67)

Text

33046 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations NUCLEAR REGULATORY available documents online in the performed. Note that the terms "ME,"

COMMISSION ADAMS Public Documents collection at "ME definition," "ME criteria," and http://www.nrc.gov/reading-rm/ "ME reporting criteria" are used 10 CFR Parts 30, 32, and 35 adams.html. To begin the search, select interchangeably in the Executive

[NRC-2008-0175] "ADAMS Public Documents" and then Summary and the Discussion sections of select "Begin Web-based ADAMS this document.

RIN 3150-AI63 Search." For problems with ADAMS,

• Training and experience please contact the NRC's Public requirements are amended in multiple Medical Use of Byproduct Material- Document Room (PDR) reference staff at sections to remove the requirement to Medical Event Definitions, Training and 1-800-397-4209, 301-415-4737, orby obtain a written attestation for an Experience, and Clarifying email to pdr.resource@nrc.gov.For the individual who is certified by a Amendments convenience of the reader, instructions specialty board whose certification AGENCY: Nuclear Regulatory about obtaining materials referenced in process has been recognized by the NRC Commission. this document are provided in the or an Agreement State. The NRC has "Availability of Documents" section. determined that certification by a ACTION: Final rule.

• NRC's PDR: You may examine and specialty board, coupled with meeting

SUMMARY

The U.S. Nuclear Regulatory purchase copies of public documents at the recentness of training requirements, Commission (NRC) is amending its the NRC's PDR, Room 01-F21, One is sufficient to demonstrate that an regulations related to the medical use of White Flint North, 11555 Rockville individual seeking authorization on a byproduct material. The final rule will Pike, Rockville, Maryland 20852. license has met the T&E requirements amend the NRC regulations related to FOR FURTHER INFORMATION CONTACT: and has the requisite current knowledge the medical use of byproduct material. Kimyata Morgan-Butler, Office of and, therefore, additional attestation by This rule amends the reporting and Nuclear Material Safety and Safeguards, a preceptor is unnecessary. Individuals notification requirements for a medical U.S. Nuclear Regulatory Commission, who are not board certified will still event (ME) for permanent implant Washington, DC 20555-0001, telephone: need to obtain a written attestation; brachytherapy. This rule also amends 301-415-0733, email: Kimyata.Morgan- however, the language of the attestation the training and experience (T&E) Butler@nrc.gov. is modified. Additionally, residency requirements to remove from multiple program directors will be allowed to SUPPLEMENTARY INFORMATION:

sections the requirement to obtain a provide these written attestations. Note written attestation for an individual Executive Summary that the terms "written attestation,"

"attestation," "preceptor statement,"

who is certified by a specialty board A. Need for the RegulatoryAction and whose certification process has been and "preceptor attestation" are used Legal Authority recognized by the NRC or an Agreement interchangeably in the Executive The NRC is amending its regulations Summary and the Discussion sections of State; and address a request filed in a related to the medical use of byproduct this document.

petition for rulemaking (PRM), PRM- material. These regulations were last

• The rule addresses the issues raised 35-20, to exempt certain board-certified amended in their entirety in 2002. Over in a petition for rulemaking (PRM individuals from certain T&E the last 14 years, stakeholders and 20) that was submitted to the NRC in requirements (i.e., "grandfather" these members of the medical community 2006. The petition requested that individuals). Additionally, this rule have identified certain issues in experienced board-certified Radiation amends the requirements for measuring implementing these regulations. As a Safety Officers (RSOs) and medical molybdenum contamination; adds a result, the NRC is updating its physicists not named on a license who new requirement for the reporting of regulations to address technological had practiced certain modalities prior to failed technetium and rubidium advances and changes in medical October 24, 2005, be exempt from the generators; and allows licensees to name procedures. The amended rule would specific T&E requirements in §§ 35.50 associate radiation safety officers also enhance patient safety. The NRC is and 35.51, respectively. In effect, they (ARSOs) on a medical license. revising parts 30, 32, and 35 of title 10 will be "grandfathered" for these DATES: This final rule is effective on of the Code of FederalRegulations (10 training requirements for the modalities January 14, 2019. CFR) under the legal authority granted that they practiced as of October 24, ADDRESSES: Please refer to Docket ID to the NRC by the Atomic Energy Act of 2005. This petition is discussed in detail NRC-2008-0175 when contacting the 1954, as amended, and the Energy in Section II., Petition for Rulemaking, NRC about the availability of Reorganization Act of 1974, as PRM-35-20, of this document.

information for this action. You may amended.

• The requirements for measuring the obtain publicly-available information molybdenum-99 (Mo-99) concentration related to this action by any of the B. MajorProvisions for elutions of Mo-99/Technetium-99m following methods:

• The final rule establishes separate (Tc-99m) generators are changed and

• FederalRulemaking Website: Go to requirements for identifying and requirements are added for reporting http://www.regulations.govand search reporting MEs involving permanent and notification of a generator eluate for Docket ID NRC-2008-0175. Address implant brachytherapy. These new exceeding permissible Mo-99, questions about NRC dockets to Carol regulations require reporting of an event strontium-82 (Sr-82), or strontium-85 Gallagher; telephone: 301-415-3463; in which there is actual or potential (Sr-85) concentrations. The occurrence email: Carol.Gallagher@nrc.gov.For harm to a patient resulting from an ME. of generator eluate exceeding technical questions, contact the Additionally, licensees are required to permissible concentrations is also individual listed in the FOR FURTHER develop, implement, and maintain referred to as "breakthrough." The INFORMATION CONTACT section of this procedures for determining if an ME has current requirement to measure the Mo-document. occurred, including procedures for 99 concentration after the first eluate is

• NRC's Agencywide Documents verifying certain aspects of a permanent changed to require that the Mo-99 Access and Management System implant brachytherapy treatment within concentration be measured in each (ADAMS): You may obtain publicly- 60 days from the date the treatment was eluate. This requirement is changed in

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33047 response to several breakthrough X. Cumulative Effects of Regulation inadequacies or unreliability of specific incidents reported to the NRC. XI. Plain Writing equipment or procedures.

• Additionally, licensees will be XII. Environmental Impact: Categorical Currently, the ME criteria for Exclusion brachytherapy implants in § 35.3045, allowed to appoint a qualified XIII. Environmental Assessment and Final individual with expertise in certain uses Finding of No Significant Environmental "Report and notification of a medical of byproduct material to be named on a Impact event," are based on the dose license to serve as an ARSO. This will XIV. Paperwork Reduction Act Statement administered to the patient. The ME make it easier for an individual to XV. Congressional Review Act criteria amendments establish separate become an RSO on other medical XVI. Criminal Penalties ME criteria for permanent implant licenses and will increase the number of XVII. Coordination With NRC Agreement brachytherapy in terms of the total individuals who are available to serve as States source strength administered (activity-XVIII. Agreement State Compatibility based) rather than the dose delivered preceptors for individuals seeking to be XIX. Coordination With the Advisory appointed as RSOs or ARSOs. Committee on the Medical Uses of (dose-based). The ME criteria Isotopes amendments in this final rule are based C. Costs and Benefits on the NRC staff recommendations XX. Consistency With Medical Policy The NRC has not established a Statement contained in SECY-12-0053, quantitative cutoff for defining an XXI. Voluntary Consensus Standards "Recommendations on Regulatory economically significant regulatory XXII. Availability of Guidance Changes for Permanent Implant action for the purposes of the XXIII. Availability of Documents Brachytherapy Programs," and the Congressional Review Act. The NRC I. Background comments received on the proposed assumes "significant" impact if the ratio rule "Medical Use of Byproduct of annualized costs to estimated annual The NRC published a final rule in the Material-Medical Event Definitions, Federal Register on April 24, 2002 (67 gross revenues for a licensee exceeds 1 Training and Experience, and Clarifying FR 20250), that revised the medical use percent. The final rule will have an Amendments," published in the Federal regulations in 10 CFR part 35 in their estimated $7.8 million implementation Register on July 21, 2014 (79 FR 42410).

entirety. The T&E requirements in 10 cost for the medical community. This The staff has concluded that dose-based CFR part 35 were further revised criteria are problematic for permanent cost will be spread over the 7,418 through an additional rulemaking, impacted licensees for an average implant brachytherapy because "Medical Use of Byproduct Material- absorbed dose can be challenging to implementation cost of approximately Recognition of Specialty Boards," calculate resulting in clinically

$1,100 per licensee. The NRC assumes published in the Federal Register on acceptable therapies being reported as that all affected licensees have annual March 30, 2005 (70 FR 16336). medical events. In addition, moving to revenues greater than $110,000.

In implementing the current activity-based criteria should allow for Therefore, the estimated cost impacts do regulations in 10 CFR part 35, the NRC recognition of medical events earlier not exceed the 1 percent criterion for "significant" impacts, and the final rule staff, stakeholders, and the Advisory than dose-based criteria, thus allowing Committee on the Medical Uses of timelier corrective actions.

is not considered an economically Isotopes (ACMUI) have identified On August 6, 2008, the NRC significant regulatory action. It will cost numerous issues that need to be published a proposed rule, "Medical the NRC approximately $65,000 to addressed through the rulemaking Use of Byproduct Material-implement this rule.

process. As a result, the NRC is Amendments/Medical Event The benefits of this final rule are amending its regulations in 10 CFR part Definitions," in the Federal Register (73 associated with reducing unnecessary 35 to address these issues. This final FR 45635), for public comment. This radiation exposure to patients, removing rule modifies the written directive (WD) proposed rule included revised ME the requirement to obtain a written requirements in § 35.40 and the ME criteria for permanent implant attestation for an individual who is reporting requirements in § 35.3045 to brachytherapy. The majority of certified by a specialty board whose establish separate ME reporting criteria commenters were in agreement on certification process has been for permanent implant brachytherapy. converting the permanent implant recognized by the NRC or an Agreement This final rule also modifies the brachytherapy ME criteria from dose-State, and affording greater flexibility to requirements for procedures for based to activity-based. However, licensees. This final rule also updates, administrations requiring a WD in during late summer and early fall of clarifies, and strengthens the existing

§ 35.41 to require licensees to develop 2008, a substantial number of MEs regulatory requirements, and, thereby, written procedures for determining if an involving permanent implant promotes public health and safety.

A regulatory analysis has been ME has occurred as a result of any brachytherapy were reported to the developed for this rulemaking and is administrations requiring a WD, NRC. Based on the circumstances discussed in Section VIII., Regulatory including permanent implant involving the MEs reported in 2008, the Analysis, of this document. brachytherapy. The NRC's purpose for NRC staff re-evaluated the proposed rule requiring licensees to report MEs is to that was published in 2008 and Table of Contents allow the NRC to follow up on incidents developed a draft re-proposed rule.

I. Background and determine if other licensees might In SECY-10-0062, "Re-proposed II. Petition for Rulemaking, PRM-35-20 be making the same or similar mistakes, Rule: Medical Use of Byproduct III. Discussion or experiencing the same or similar Material-Amendments/Medical Event A. What action is the NRC taking? challenges. When the NRC identifies Definitions," dated May 18, 2010, the B. When will these actions become similarities in the problems reported NRC staff requested that the effective? from multiple facilities, it can provide Commission approve for publication the IV. Opportunities for Public Participation information that may help prevent draft re-proposed rule for public V. Public Comment Analysis VI. Section-by-Section Analysis additional incidents. The information comment. Prior to a Commission VII. Regulatory Flexibility Certification collected is also valuable in assessing decision on the re-proposed rule, on VIII. Regulatory Analysis trends or patterns, identifying generic July 8, 2010, a Commission briefing was IX. Backfitting and Issue Finality issues, and recognizing any held on the draft re-proposed rule. The

33048 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations presenters included a member of the brachytherapy, the NRC is amending its October 24, 2005, be exempted from the ACMUI, a representative from the regulations in 10 CFR part 35 to: Revise specific T&E requirements in §§ 35.50 Organization of Agreement States the preceptor attestation requirements; and 35.51, respectively. In effect, they (OAS), a physician from the American require increased frequency of testing would be "grandfathered" for these Brachytherapy Society, the National for measuring Mo-99 concentration in a training requirements for the modalities Director of the Radiation Oncology Mo-99/Tc-99m generator; require that they practiced on or before October Program of the Department of Veterans reporting and notification when a 24, 2005. The petitioner was concerned Affairs, a representative from the generator eluate exceeds permissible that as a result of the amendments to the American Association of Physicists in Mo-99, Sr-82, or Sr-85 concentrations; T&E regulations in 2005, an individual Medicine (AAPM), and a representative allow ARSOs to be named on a medical could become authorized on a license from Us-TOO (a support group for use license; extend the 5-year inspection only if he or she had been certified by prostate cancer patients). The presenters frequency for a gamma stereotactic a specialty board whose certification urged the Commission not to publish radiosurgery unit to 7 years; and make process was recognized under this the draft re-proposed rule as developed. several clarifying amendments. regulation by the NRC or an Agreement They believed that MEs should be based Finally, this final rule addresses State or was already identified on an on events of potential clinical issues that were raised in PRM-35-20 existing NRC or Agreement State significance and recommended that the filed by E. Russell Ritenour, Ph.D., on license. If the individual had been NRC seek stakeholder input in revising behalf of the AAPM on September 13, certified prior to the effective date for this proposed rule. 2006. The petition requested that the recognition of the certifying board but In the Staff Requirements training requirements for experienced had not been listed on a license, he or Memorandum (SRM) for SECY RSOs and medical physicists in § 35.57 she would not be "grandfathered," and 0062, dated August 10, 2010, the be amended to recognize board-certified would have to obtain training through Commission disapproved the NRC physicists and RSOs as "grandfathered" the so-called "alternate pathway,"

staff's recommendation to publish the for the modalities that they practiced as which establishes specific training draft re-proposed rule. The Commission of October 24, 2005. The petition is requirements for non-certified directed the staff to work closely with discussed in detail in Section II., individuals. The petitioner did not the ACMUI and the broader medical and Petition for Rulemaking, PRM-35-20, of believe that it was the intent of the stakeholder community to develop ME this document. This final rule completes Commission to deny recognition to definitions that would protect the action on PRM-35-20. individuals currently practicing or to interests of patients and allow minimize the importance of certification II. Petition for Rulemaking, PRM-35-20 physicians the flexibility to take actions by a certifying board. The NRC received that they deem medically necessary, The NRC has incorporated into this 168 comments from professional while continuing to enable the agency to rulemaking the resolution of PRM organizations and individuals on the detect failures in process, procedure, 20 filed by E. Russell Ritenour, Ph.D. petition. The majority of the and training, as well as any (the petitioner), dated September 10, commenters supported the petition.

misapplication of byproduct materials 2006, on behalf of the AAPM (Ritenour The NRC reviewed the petitioner's by authorized users (AUs). The SRM Petition). A notice of receipt and request request and comments received on the also directed the NRC staff to hold a for public comments on this petition petition and concluded that revisions series of stakeholder workshops to was published in the Federal Register made to the regulations in 2005 may discuss issues associated with the ME on November 1, 2006 (71 FR 64168). have inadvertently affected a group of definition. For more information, The petitioner requested that § 35.57, board-certified individuals. This group including public comments submitted "Training for experienced Radiation of board-certified individuals may now on the proposed rule published on Safety Officer, teletherapy or medical have to use the alternate pathway option August 6, 2008, (see Docket ID NRC- physicist, authorized medical physicist, to demonstrate that they meet the T&E 2008-0071 on www.regulations.gov). authorized user, nuclear pharmacist, requirements in 10 CFR part 35 rather Following Commission direction, the and authorized nuclear pharmacist," be than the certification pathway for NRC conducted two workshops in the revised to: (1) Recognize medical recognition on an NRC license as an summer of 2011. These facilitated physicists certified by either the RSO or an authorized medical physicist workshops were held in New York, New American Board of Radiology or the (AMP). Therefore, the NRC concluded York, in June 2011, and in Houston, American Board of Medical Physics on that the issues raised in the petition Texas, in August 2011. The NRC staff or before October 24, 2005, as would be considered in the rulemaking "grandfathered" for the modalities that also requested the ACMUI to prepare a process if a regulatory basis could be report on ME definitions for permanent they practiced as of October 24, 2005, developed to support a rulemaking (73 implant brachytherapy. In February regardless of whether a medical FR 27773; May 14, 2008).

2012, the ACMUI submitted its final physicist was named on an NRC or an In October 2008, the NRC staff sent revised report to the NRC. The NRC staff Agreement State license as of October letters to all of the certifying boards used the recommendations in the 24, 2005; and (2) recognize all whose certification processes are ACMUI revised final report, along with individuals certified by the named currently recognized by the NRC and to the substantial input from stakeholders, boards in former subpart J of 10 CFR certifying boards previously named in to develop the recommendations in part 35, which was removed from 10 the former 10 CFR part 35, subpart J, SECY-12-0053. The recommendations CFR part 35 in a rulemaking dated whose certification processes currently in SECY-12-0053, along with public March 30, 2005 (70 FR 16336), as RSOs are not recognized by the NRC. To comments received on the proposed who have relevant timely work determine the scope of the medical rule published on July 21, 2014 (79 FR experience (even if they have not been community that might be negatively 42410), provided the regulatory basis for formally named as an RSO). The impacted by the amendments to the T&E the ME reporting criteria in this final petitioner requested that experienced regulations in 2005, the NRC asked each rule. board-certified RSOs and medical organization to provide the number and In addition to revising the ME physicists not named on a license who percentage of its currently active definitions for permanent implant had practiced certain modalities prior to diplomates who are not grandfathered

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33049 under § 35.57 by virtue of not being III. Discussion ACMUI explained that for these named on a license or permit. The implants, the plus or minus 20 percent A. What action is the NRC taking?

organizations were asked to include variance from the WD criteria in the individuals who are now or may seek to In implementing the current existing rule was only appropriate if be named as an RSO, AMP, AU, or regulations in 10 CFR part 35, the NRC both the WD and the variance could be authorized nuclear pharmacist (ANP) on staff, stakeholders, and the ACMUI expressed in units of activity, rather an NRC or an Agreement State medical identified numerous issues that need to than in units of dose. The ACMUI use license. Based on the responses, the be addressed through the rulemaking explained that there is no suitable process. The NRC published a proposed clinically used dose metric available for NRC estimates that as many as 10,000 rule on July 21, 2014 (79 FR 42410), for judging the occurrence of MEs for board-certified individuals may have a 120-day public comment period to permanent implant brachytherapy. In been affected by the 2005 T&E address these issues. The NRC June 2005, the ACMUI recommended rulemaking. developed this final rule based on the that new language be developed to The NRC believes that these comments received on the proposed define MEs for permanent implant individuals should be eligible for rule. The comments are discussed in brachytherapy.

grandfathering for the modalities that Section V., Public Comment Analysis, of Based on the recommendations from they practiced on or before October 24, this document. the ACMUI, the NRC staff submitted a 2005, because their previously- The final rule clarifies the current paper to the Commission, SECY acceptable qualifications for authorized regulations and provides greater 0234, "Adequacy of Medical Event status should continue to be adequate flexibility to licensees without Definitions in § 35.3045, and and acceptable from a health and safety compromising patient, worker, or public Communicating Associated Risks to the standpoint and thus they should be health and safety. The amendments in Public," dated December 27, 2005. In allowed to continue to practice using this final rule include: this paper, the NRC staff recommended the same modalities. This final rule, in 1. Adding separate ME definitions for that the Commission approve, for permanent implant brachytherapy; permanent implant brachytherapy, the response to the petition, amends § 35.57

2. amending preceptor attestation NRC staff's plan to revise the ME to recognize all individuals who were requirements; previously certified by boards definitions in § 35.3045 and the

3. grandfathering certain board-recognized under the previous 10 CFR associated requirements for WDs in certified individuals, as discussed in part 35, subpart J, as RSOs, teletherapy § 35.40 to be activity-based, instead of Section II., Petition for Rulemaking, or medical physicists, AMPs, AUs, dose-based. In the SRM for SECY PRM-35-20, of this document; nuclear pharmacists, and ANPs for the 0234, dated February 15, 2006, the

4. requiring increased frequency of modalities that they practiced on or Commission directed the NRC staff to testing to measure Mo-99 breakthrough; before October 24, 2005. 5. requiring reporting and notification proceed directly with the development when a generator eluate exceeds of a proposed rule to modify both the In his support for grandfathering the WD requirements in § 35.40(b)(6) and RSOs who have relevant work permissible concentrations of Mo-99, Sr-82, Sr-85; the ME reporting requirements in experience and were not formally § 35.3045 for permanent implant

6. allowing ARSOs to be named on a named on an NRC or an Agreement brachytherapy medical use, to convert medical use license; and State license or permit as an RSO, the 7. additional issues and clarifications. from dose-based to activity-based ME petitioner stated that these individuals The major revisions are: criteria.

will be required to provide preceptor As discussed in Section I.,

attestations. In this rulemaking, the NRC a. Adding Separate ME Definitions for Background, of this document, a has eliminated the requirement for Permanent Implant Brachytherapy proposed rule was published in the preceptor attestations for individuals This final rule establishes separate Federal Register on August 6, 2008 (73 certified by NRC- or Agreement State- ME definitions and reporting FR 45635). A substantial number of MEs recognized boards. The NRC believes requirements for permanent implant were reported in 2008 that would not that attestations are not necessary in this brachytherapy. The staff has concluded have met the criteria for reporting under particular situation because the that dose-based criteria are problematic the activity-based ME reporting criteria provisions of § 35.59, "Recentness of for permanent implant brachytherapy as noticed in the proposed rule.

training," require that the T&E must because absorbed dose can be Therefore, the NRC staff drafted a have been obtained within the 7 years challenging to calculate resulting in different rule that contained absorbed preceding the date of application, or the clinically acceptable therapies being dose-based ME reporting criteria for the individual must have had related reported as medical events. In addition, treatment site. The NRC staff submitted continuing education and experience moving to activity-based criteria should recommendations for ME reporting allow for recognition of medical events criteria to the Commission in SECY since the required T&E was completed.

earlier than dose-based criteria, thus 0062, "Reproposed Rule: Medical Use of The "grandfathered" individuals will allowing timelier corrective actions. As Byproduct Material-Amendments/

fall under the provisions of § 35.59 and explained in Section I, Background, of Medical Event Definitions," dated May will need to provide evidence of this document, these amendments are 18, 2010. In the SRM for SECY continued education and experience. based on the recommendations 0062, dated August 10, 2010, the Therefore, the NRC believes that developed in close cooperation with the Commission disapproved the NRC preceptor attestations are not necessary ACMUI, with substantial input from staff's recommendations and directed for these "grandfathered" individuals as various stakeholders, and from public the NRC staff to work closely with the long as the provisions of § 35.59 are met, comments received on the proposed ACMUI and the broader medical and and the individual only requests rule. During its meeting in March 2004, stakeholder community to develop ME authorizations for the modalities the the ACMUI discussed the inadequacy of definitions and to hold a series of individual practiced on or before the definition of MEs as applied to stakeholder workshops to discuss issues October 24, 2005. permanent implant brachytherapy. The associated with the MEs.

33050 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations Subsequently, during the ACMUI Commission on April 6, 2012, in SECY- tissues located both outside and within meeting held on October 20, 2010, the 12-0053, "Recommendations on the treatment site in defining MEs.

ACMUI unanimously approved its Regulatory Changes for Permanent The NRC received numerous interim report, "Advisory Committee on Implant Brachytherapy Programs." In a comments expressing concern about the Medical Uses of Isotopes Permanent Commission meeting held April 24, proposed ME criteria related to the Implant Brachytherapy Interim Report," 2012, participating representatives from absorbed dose to normal tissues located dated October 20, 2010. The ACMUI ACMUI, ASTRO, and the American outside and within the treatment site.

meeting held in April 2011 was devoted Brachytherapy Society (ABS) endorsed The commenters expressed concerns to issues associated with the ME the recommendations in SECY-12-0053 that they would have technical definition. The meeting was webcast, for modification of the requirements in difficulties assessing dose to normal providing an opportunity for further §§ 35.40 and 35.3045. The NRC notes tissues located outside and within the public involvement on this issue. that ASTRO and ABS representatives treatment site. They stated that their The ACMUI submitted its final report suggested eliminating the recommended treatment planning systems are not on permanent implant brachytherapy, equipped to make such assessments.

criterion for ME reporting that would dated October 18, 2011, to the NRC They believed the regulators may not be have required reporting of excessive following the ACMUI October 18, 2011, able to inspect such requirements. They dose to normal tissue structures within public teleconference meeting. The final stated that these requirements may report reflected the principal positions the treatment site. However, this cause confusion and result in licensees and recommendations provided by ACMUI-recommended ME reporting not performing permanent implant participants during the NRC public criterion for normal tissue structures brachytherapy treatments. The workshops. In particular, the report located within the treatment site was comments are discussed in Section V.,

included the recommendation to change retained in SECY-12-0053 because the Public Comment Analysis, of this from dose-based ME criteria for the ACMUI and the NRC staff determined document.

treatment site to source-strength based that there should be some form of ME Based on public comments and criteria. The final report included a reporting criterion for overdosing of recommendations from the ACMUI, the quantitative metric, the "octant normal tissue structures located within ME criteria in this final rule for approach," for determining that a the treatment site. In the SRM for permanent implant brachytherapy in distribution of implanted sources was SECY-12-0053, dated August 13, 2012, § 35.3045(a)(2) do not include absorbed irregular enough (i.e., demonstrating the Commission approved the NRC staff doses to normal tissues located outside "bunching") to consider the procedure recommendations. The of or within the treatment site. Instead, as an ME. The final report also included recommendations are applicable to all the ME criteria in the final rule for a dose-related ME criterion for the permanent implant brachytherapy permanent implant brachytherapy are:

treatment site. procedures using radioactive sources for (1) An ME has occurred if the total However, in a letter to the Chairman all treatment sites. source strength administered differs by of the ACMUI dated November 30, 2011, The proposed rule published on July 20 percent or more from the total source the American Society for Radiation 21, 2014 (79 FR 42410) also included strength documented in the post-Oncology (ASTRO) expressed criticism ME criteria in § 35.3045(a)(2)(iii) and implantation portion of the WD; of the ACMUI final report. The ASTRO (2) An ME has occurred if the total (iv) as follows: For normal-tissue considered the ME definition source strength administered outside of structures, an ME has occurred if: (a) recommended by the ACMUI to be the treatment site exceeds 20 percent of For structures located outside of the complex, difficult to regulate, and likely the total source strength documented in treatment site (for example, the bladder to cause confusion in practice. the post-implantation portion of the or rectum for prostate implant Subsequently, the ACMUI issued a WD; or treatments), the dose to the maximally (3) An ME has occurred if an revised final report, "Advisory exposed 5 contiguous cubic centimeters administration involves: (a) Using the Committee on Medical Use of Isotopes of tissue exceeds 150 percent of the wrong radionuclide, (b) delivery to the (ACMUI) Permanent Implant Brachytherapy Revised Final Report," absorbed dose prescribed to the wrong individual or human research dated February 7, 2012. The ACMUI treatment site in the pre-implantation subject, (c) sealed source(s) implanted simplified the ME criteria for the portion of the WD; or (b) for intra-target directly into a location discontiguous treatment site, removing the "octant normal structures, the maximum from the treatment site as documented approach" and direct reference to absorbed dose to any 5 contiguous cubic in the post-implantation portion of the absorbed dose to the treatment site. The centimeters of tissue exceeds 150 WD (as discussed in this document, revised final report was, with minor percent of the dose the tissue would discontiguous means a location that is modifications, approved by the ACMUI have received based on the approved not physically adjacent to the treatment during its public teleconference meeting pre-implantation dose distribution. The site), or (d) a leaking sealed source held on February 7, 2012. The ASTRO, size of the normal tissue, 5 cubic resulting in a dose that exceeds 0.5 Sv in a letter to the Chairman of the centimeters, was based on an ACMUI (50 rem) to an organ or tissue.

ACMUI, characterized this report as an recommendation in its October 20, In supporting these recommendations, improvement on the earlier report. 2010, report. In its recommendation, the the NRC believes that source strength is The NRC staff used the ACMUI stated that the 5 contiguous the appropriate measurable metric for recommendations in the ACMUI revised cubic centimeters dose-volume defining MEs involving permanent final report dated February 7, 2012, specification avoids the high variation implant brachytherapy. The 20 percent along with the substantial input from in dose sometimes seen in point doses variance threshold is consistent with the stakeholders gathered in the two and the ACMUI cited literature to recommendation of the ACMUI for all facilitated public workshops and the support 5 cubic centimeters as being a medical uses of byproduct material as three ACMUI public meetings in 2011 relevant quantity for toxicity. In the described in SECY-05-0234, discussed and early 2012 (discussed earlier in this proposed rule, the NRC specifically earlier in this section.

section), to develop the invited comments on the selection of Another ME criterion included in the recommendations submitted to the the specified volume of the normal proposed rule published on July 21,

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33051 2014 (79 FR 42410), was related to Public Comment Analysis, of this that a licensee determine that an source(s) implanted directly into the document. administered dose or dosage met an ME wrong site or body part (i.e., not in the The new ME criteria for permanent criterion as defined in § 35.3045.

treatment site identified in the WD). implant brachytherapy in § 35.3045 Section 35.41 is amended to require that This criterion stated that "even a single require amendments to §§ 35.40 and a licensee develop procedures for sealed source directly delivered to the 35.41. The previous WD requirements determining if an ME has occurred. For wrong treatment site would constitute were primarily associated with all permanent implant brachytherapy, an ME that must be reported." The NRC temporary implant brachytherapy § 35.41 is also amended to require that received several comments on this medical use. This final rule establishes a licensee develop additional issue. The commenters believed a single separate WD requirements in § 35.40, procedures to include an evaluation of source delivered outside the treatment "Written directives," that are the placement of sources as documented site was an inappropriate criterion for appropriate for permanent implant in the post-implantation portion of the ME reporting. They proposed that in brachytherapy. This rule requires that WD. The procedures must include a order to capture instances where a the WD for permanent implant provision that these assessments must source is implanted in a distinctly brachytherapy consist of two portions. be made within 60 days from the date wrong location (for example, left breast The first portion of the WD must be the treatment was performed. Although versus the right breast), the criterion prepared before the implantation, and there is no requirement in § 35.41 to use should say, "Even a single sealed source the second portion of the WD must be imaging to determine the occurrence of directly delivered to a noncontiguous completed after the procedure but an ME, imaging is the best (and in some wrong treatment site would constitute before the patient leaves the post- circumstances may be the only) method an ME that must be reported." treatment recovery area. For permanent to determine source strength outside of In response to these comments and a implant brachytherapy, this rule the treatment site and is routinely recommendation from the ACMUI in its requires that the WD portion prepared practiced in most clinical facilities.

final report on the draft final rule before the implantation include documentation of the treatment site, the b. Amending Preceptor Attestation

("Advisory Committee on the Medical Requirements Uses of Isotopes Comments on the Draft radionuclide, and the total source strength. This final rule requires that the The current regulations in 10 CFR Final Rule, 10 CFR parts 30, 32, and 35, post-implantation portion of the WD part 35 provide three pathways for Final Report," dated January 6, 2016),

contain documentation of the treatment individuals to satisfy T&E requirements the NRC has changed site, the number of sources implanted, to be approved as an RSO, AMP, ANP,

§ 35.3045(a)(2)(v)(C) [redesignated as or AU. These pathways are: (1) the total source strength implanted, and

§ 35.3045(a)(2)(iii)(C) to read "Sealed Approval of an individual who is the date.

source(s) implanted directly into a certified by a specialty board whose Based on ACMUI input discussed location discontiguous from the certification process has been earlier in this section and information treatment site as documented in the recognized by the NRC or an Agreement gained at public workshops, the NRC post-implantation portion of the written understands that the final WD for these State (certification pathway); (2) directive." approval based on an evaluation of an permanent implants must allow for This "wrong treatment site" ME unanticipated medical situations individual's T&E (alternate pathway); or criterion will capture cases in which encountered during the procedure. For (3) identification of an individual's total source strength administered instance, an AU might need to adjust approval on an existing NRC or outside of the treatment site did not the number of sources implanted Agreement State license.

exceed 20 percent of the total source because the volume of the treatment site Under the certification and the strength documented in the post- may have decreased since the treatment alternate pathway, an individual implantation portion of the WD, but one plan was developed. Therefore, in seeking authorization for medical or more sources were directly implanted defining an ME involving the treatment byproduct material must obtain a into a location far from the treatment site for permanent implants, the NRC written attestation signed by a preceptor site. For example, in a case in which based the criterion for an ME on the with the same authorization. The 100 sources were implanted, 81 were percentage of implanted sources that are attestation must state that the individual within the treatment site, 18 sources outside the treatment site as has satisfactorily completed the were outside and contiguous to the documented in the post-implantation necessary T&E requirements and has treatment site, and one source was portion of the WD rather than by achieved a level of competency erroneously implanted directly into a defining an ME based on a comparison sufficient to function independently in site discontiguous from the treatment of the implanted total source strength to the position for which authorization is site. This would not be an ME under the the total source strength documented in sought.

"exceeds 20 percent of the total source During a Commission briefing held on the pre-implantation portion of the WD.

strength" criterion; but would be an ME This definition differs from the ME April 29, 2008, the ACMUI because one source met the "wrong definition for all other brachytherapy recommended that the attestation treatment site" criterion. procedures where dose comparisons are requirements be revised. The ACMUI The proposed criterion specified in made with reference to what was expressed concern that the existing

§ 35.3045(a)(2)(v)(E), "a 20 percent or prescribed in the WD that was prepared requirements have had unintended more error in calculating the total before the procedure. consequences that, if not corrected, source strength documented in the pre- This final rule also makes changes to would impact the availability of implantation portion of the written § 35.41, "Procedures for administrations authorized individuals. In other words, directive," in the proposed rule requiring a written directive," to there would likely be a shortage of published on July 21, 2014, was not include permanent implant authorized individuals to provide included in the final rule. The decision brachytherapy. Although § 35.41(a)(2) medical care as a result of the reluctance not to include this criterion is based on requires licensees to determine if the of preceptors to sign attestations. The the comments received on the proposed administration is in accordance with the ACMUI recommended that attestations rule and is discussed in Section V., WD, there is no specific requirement be eliminated for the board certification

33052 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations pathway. In the ACMUI's view, by 10 CFR part 35, Medical Use of attestation requirements in accordance meeting the board requirements, a Byproduct Material." The NRC staff with the NRC staff's recommendations curriculum and a body of knowledge recommended that the Commission in SECY-08-0179.

can be defined, and progress toward approve development of the following

c. Extending Grandfathering to Certain meeting defined requirements can be amendments to the 10 CFR part 35 Certified Individuals (PRM-35-20) measured. Further, the ACMUI asserted attestation requirements: (1) Eliminate that a board certification indicates that the attestation requirement for The petition and its resolution are the T&E requirements have been met, individuals seeking authorized status discussed in Section II., Petition for and the Maintenance of Certification via the board certification pathway; (2) Rulemaking, PRM-35-20, of this provides ongoing evidence of current retain the attestation requirement for document.

knowledge. Therefore, the ACMUI individuals seeking authorized status d. Requiring Increased Frequency of asserted that an additional attestation via the alternate pathways; however, Testing To Measure Mo-99 for the board-certified individuals was replace the text stating that the Breakthrough not needed. attestation demonstrates that the The ACMUI also recommended that individual "has achieved a level of When Tc-99m is eluted from a Mo-99 the attestation requirements associated competency to function independently" generator, Mo-99 could be co-eluted with the alternate pathways be amended with alternative text such as "has along with technetium. This is termed "molybdenum breakthrough." Current to delete the requirement to attest to an demonstrated the ability to function individual's radiation safety-related independently" to fulfill the radiation regulations in § 35.204(a) prohibit a competency. The reason for the safety-related duties required by the licensee from administering a recommendation was that the ACMUI license; and (3) accept attestations from radiopharmaceutical to humans that believed that signing an attestation of residency program directors, exceeds 0.15 microcuries of Mo-99 per competence results in a perceived risk representing consensus of residency millicurie of Tc-99m. Section 35.204(b) of personal liability on the part of the program faculties as long as at least one requires that a licensee that uses Mo-99/

individual signing the attestation and member of the residency program Tc-99m generators for preparing a Tc-that preceptors are reluctant to accept faculty is an authorized individual in 99m radiopharmaceutical measure the this risk. the same category as that requested by Mo-99 concentration of the first eluate In addition, the ACMUI the applicant seeking authorized status. to demonstrate compliance with the recommended that the attestation In an SRM dated January 16, 2009, to specified concentrations. However, a submitted under the alternate pathway SECY-08-0179, the Commission generator can be eluted several times to be considered acceptable if it is approved these recommendations and obtain Tc-99m for formulating provided by a residency program directed the NRC staff to develop the radiopharmaceuticals for patient use.

director representing a consensus of an proposed rule language for the If Mo-99 breakthrough exceeds the authoritative group, irrespective of attestation requirements for the alternate permissible concentration listed in whether the program director personally pathway in concert with the ACMUI § 35.204(a), it may cause unnecessary met the requirements for AU status. The and the Agreement States. radiation exposures to patients. The ACMUI advised that training of Participants at public workshops held administration of higher levels of Mo-99 residents is a collective process and in the summer of 2011 broadly could potentially affect health and entails the collective judgment of an supported the proposed changes to safety and have an adverse effect on entire residency program faculty, remove the attestation requirement for nuclear medicine image quality and whereas preceptor attestation is an board-certified individuals. The medical diagnosis.

individual process, and an individual workshop panelists (which included Generator manufacturers have always preceptor typically would provide only members of the ACMUI and the recommended testing each elution prior a small portion of the T&E. Agreement States) recommended that to use in humans. Before 2002, § 35.204 Following the April 29, 2008, the NRC remove the requirement for required a licensee to measure the Mo-Commission briefing, in an SRM dated attestation for board-certified 99 concentration of each eluate.

May 15, 2008, the Commission directed individuals. They believed that board However, the NRC revised § 35.204 in the NRC staff to work with the ACMUI certification coupled with the April 2002 because the medical and and the Agreement States to provide recentness of training requirements pharmaceutical community considered recommendations to the Commission should be sufficient for the regulator's frequency of Mo-99 breakthrough to be with regard to amending the NRC's needs. With regard to the language of a rare event. Therefore, the Commission requirements for preceptor attestation attestation (for the alternate pathway), decided that measuring only the first for both board-certified individuals and they believed that the preceptors should elution from a generator was necessary for individuals seeking authorization via not attest to someone's competency; to detect manufacturing issues or the alternate pathway. The Commission rather, they should attest that the generators that may have been damaged also directed the NRC staff to consider individuals received the T&E that is in transport.

additional methods, such as having the necessary to carry out one's From October 2006 to February 2007, attestation provided by consensus of an responsibility independently. At the and again in January 2008, medical authoritative group. April 2011 ACMUI meeting, the ACMUI licensees reported to the NRC that Following both consideration of the advised that the attestation language numerous generators had failed the Mo-ACMUI's position, which was should be revised to say that the 99 breakthrough tests. Some licensees consistent with its long-held position on individual has received the requisite reported the failed tests in the first this issue, and interactions with the T&E to fulfill the radiation safety-related elution, while some reported an Agreement States, the NRC staff duties required by the license. In the acceptable first elution but failed provided its recommendations on this final rule, the attestation language is subsequent elutions. One generator issue to the Commission on November revised accordingly. manufacturer voluntarily reported 116 20, 2008, in SECY-08-0179, The final rule amends T&E total elution test failures in 2008. Based "Recommendations on Amending requirements in multiple sections of 10 upon the numerous reports of failed Mo-Preceptor Attestation Requirements in CFR part 35 with regard to the 99 breakthrough measurements noted in

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33053 the subsequent elutions, the NRC is f. Allowing ARSOs To Be Named on a they are listed. Because AUs, AMPs, and amending § 35.204 to return to the pre- Medical Use License ANPs must meet the same requirements 2002 performance standard, which Currently, § 35.24(b) requires a to serve as the RSO regardless of which required licensees to measure the Mo-99 licensee's management to appoint an medical use license they are identified concentration for each elution of the RSO who, in writing, agrees to be on, the NRC believes that it is overly Mo-99/Tc-99m generator at the time of responsible for implementing the restrictive not to allow them to serve as generator elution. radiation protection program. Further, an RSO on any medical use license.

the regulations in 10 CFR part 35 do not Therefore, a modification is made that

e. Requiring Reporting and Notification allow the naming of more than one will allow an AU, AMP, or ANP listed of Generator Eluates Exceeding permanent RSO on a license. on any medical use license or permit to Permissible Concentrations of During an ACMUI meeting in June serve as an RSO or ARSO. This change Molybdenum-99, Strontium-82, or will increase the number of individuals Strontium-85 2007, ACMUI members expressed a concern that this restriction has available to serve as RSOs and ARSOs The regulations do not currently contributed to a shortage of available on NRC medical licenses. Additionally, require reporting to the NRC when an RSOs to serve as preceptors. The these ARSOs and RSOs could serve as elution from a Mo-99/Tc-99m or Sr-82/ ACMUI stated that the restriction has preceptors for an individual seeking to Rb-82 generator exceeds the regulatory created a situation in which an be named as the RSO.

limit in § 35.204(a). As discussed in this Participants at the public workshops individual who is qualified and section, eluates from Mo-99/Tc-99m performing the same duties as an RSO held in the summer of 2011 broadly generators exceeded the permissible supported the proposed change to allow cannot be recognized or listed as an concentration listed in § 35.204(a) on an ARSO to be named on a license. The RSO, and that this restriction has numerous occasions in 2006, 2007, and created a situation in which an T&E requirements for an ARSO were 2008. Additionally, in 2011, issues with discussed, and stakeholders strongly individual working as a contractor RSO Sr-82/Rb-82 generators were discovered at several hospitals or other licensed supported the NRC's position that the when several individuals were locations is unable to have actual day- ARSOs must meet the same identified with unexpectedly high levels qualifications as the RSO for their to-day oversight at the various facilities.

of Sr-82 and Sr-85. These individuals The final rule amends the regulations assigned sections of the radiation safety had undergone Rb-82 chloride cardiac in 10 CFR part 35 to allow a licensee to program.

scanning procedures several months The final rule amends multiple appoint a qualified individual with prior and had received these sections of 10 CFR part 35 to expertise in certain uses of byproduct radionuclides in levels greatly in excess accommodate the new ARSO position.

material to serve as an ARSO. This of the administration levels permitted in individual will be required to complete g. Additional Issues and Clarifications

§ 35.204 for Sr-82/Rb-82 generators. the same T&E requirements as the Further investigations showed that at Additional amendments are discussed named RSO for the individual's in Section VI, Section-by-Section least 90 individuals at one facility and assigned sections of the radiation safety 25 at another facility received levels of Analysis, of this document.

program. The ARSOs will have Sr-82 or Sr-85 that exceeded the levels oversight duties for the radiation safety B. When will these actions become permitted in § 35.204. Of these patients, operations of their assigned sections, effective?

at least three had levels of Sr-82 and Sr- while reporting to the named RSO. The The final rule will become effective 85 high enough to result in reportable regulation will continue to allow a 180 days from its publication in the MEs as defined in § 35.3045. licensee to name only one RSO on a Federal Register. In the proposed rule Because the reporting of a generator license. The RSO will continue to be published on July 21, 2014, the NRC when the eluate exceeded permissible responsible for the day-to-day oversight requested comments on whether a 180-concentrations was voluntary, the NRC of the entire radiation safety program. day effective date for the final rule is had difficulty determining the extent of Similarly, a licensee with multiple sufficient to communicate the changes potential problems. Reporting of results operating locations could appoint a to all practitioners, and for practitioners in excess of the levels in § 35.204 for the qualified ARSO at each location where to revise procedures, train on them, and Sr-82/Rb-82 generators could have byproduct material is used; however, implement the changes. The NRC alerted users and regulators to issues the named RSO will remain responsible received three comments on this associated with these generators and for the overall licensed program. Under question. These comments are discussed possibly reduced the number of patients the final rule, the ARSO will be named in Section V., Public Comment exposed to excess levels of Sr-82 and Sr- on the license for the types of use of Analysis, of this document. Based on

85. Breakthrough of Mo-99, or Sr-82 and byproduct material for which this the comments received, the NRC has Sr-85 contaminants can lead to individual is qualified and has been determined that a 180-day effective date unnecessary radiation exposure to assigned duties and tasks by the RSO. is sufficient to implement the final rule.

patients. The NRC believes that allowing an This final rule also adds a new ARSO to be named on a license will IV. Opportunities for Public reporting requirement for a generator increase the number of individuals who Participation eluate exceeding permissible will be available to serve as preceptors The NRC staff submitted a proposed concentrations of Mo-99 or Sr-82 and for individuals seeking to be appointed rule to the Commission for approval on Sr-85. This new reporting requirement as RSOs or ARSOs. Also, an ARSO August 8, 2013, SECY-13-0084, in § 35.3204(a) requires a licensee to named on a license could more easily "Proposed Rule: Medical Use of report to the NRC and the manufacturer become an RSO on other licenses for the Byproduct Material-Medical Event or distributor of medical generators types of uses for which the ARSO is Definitions, Training and Experience, within 7 calendar days any qualified. and Clarifying Amendments." The measurement that exceeds the limits in In addition, the current regulations Commission approved the NRC staff's

§ 35.204(a), at the time of generator allow AUs, AMPs, and ANPs to serve as recommendation to publish the elution. the RSO only on the license for which proposed rule, with certain changes

33054 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations directed by the Commission, in the SRM representatives from the ACMUI, dose criteria for normal tissues. The to SECY-13-0084, dated, January 6, Agreement States, and professional commenters stated numerous practical 2014. The proposed rule (79 FR 42410) societies, and a patients' rights difficulties in making these dose was published on July 21, 2014, for a advocate. assessments. They stated that the 120-day comment period that ended on For certain amendments, the NRC volume of a maximally exposed 5 November 18, 2014. However, the posted preliminary draft rule text contiguous cubic centimeters of normal proposed rule inadvertently omitted the (ADAMS Accession No. ML111390420) tissue appears reasonable in theory.

one-time implementation costs from the for a 75-day comment period on However, it will be difficult to information collection burden estimate. www.regulations.gov.The availability of determine in practice with current Therefore, a correction to the proposed the draft rule language was noticed in technology. They expressed concern rule (79 FR 56524) was published in the the Federal Register on May 20, 2011 that the treatment planning systems Federal Register on September 22, 2014, (76 FR 29171). The NRC received 11 typically report dose-volume histograms correcting the information collection comment letters on this preliminary to structures, but they do not identify burden estimate and allowing the public draft rule text. These comment letters contiguous volumes. Based on these 30 days to comment on the information are also posted on www.regulations.gov concerns, this final rule ME criteria in collection burden. under Docket ID NRC-2008-0175. The § 35.3045 does not include dose to During the comment period, the NRC NRC staff reviewed the comments and normal tissues located outside, or staff held a public meeting on October considered them in developing the within the treatment site.

8, 2014, to better inform stakeholders of proposed rule text. There were numerous comments on the proposed amendments and the the compatibility category for the various methods by which to provide V. Public Comment Analysis Agreement States for § 35.3045, Report comments on the proposed rule. Also, a A. Overview of Public Comments and notification of a medical event.

public meeting was held on February Members of the medical community 10, 2015, to better understand the The NRC received 69 comment letters submitted ten comments in support of comments made by Spectrum that contained over 100 individual Compatibility Category B. The OAS, the Pharmaceuticals. Spectrum comments. The comment letters are Conference of Radiation Control Pharmaceuticals expressed concern posted on www.regulations.gov under Program Directors (CRCPD), and all 7 of about the proposed additional case work Docket ID NRC-2008-0175. The the Agreement States that submitted requirements in § 35.396 for the commenters included several comments supported Compatibility radionuclides used primarily for their professional societies including the Category C. This issue is fully discussed alpha emissions and requested the NRC American Brachytherapy Society, in Part I, Public Comments on the require 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> rather than the American College of Radiology, Health Specific Issues on Which the NRC required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of specialized Physics Society, American Academy of Requested Comments.

training for any physician so that an Health Physics, American Society for The commenters expressed concern oncologist or a hematologist may Radiation Oncology, American about confusion among AUs administer parenteral radioactive drugs. Association of Physicists in Medicine, surrounding the definition of ME and Early public input on the proposed Council on Radionuclides and WDs related to Yttrium-90 (Y-90) rule was solicited through various Radiopharmaceuticals, the Organization microspheres. The NRC staff has mechanisms. The proposed of the Agreement States, and the determined that the use of Y-90 would amendments and preliminary draft rule Conference of Radiation Control continue to be licensed under § 35.1000, text were discussed at the two Program Directors. Other commenters "Other medical uses of byproduct transcribed facilitated public workshops included individual States, practicing material or radiation from byproduct that were conducted in New York City, physicians, medical physicists, RSOs, material."

New York, on June 20-21, 2011; and in nuclear pharmacists, individual The commenters were generally Houston, Texas, on August 11-12, 2011. members of the public, and a member of supportive of the proposed regulation The purpose of the workshops was to Congress. The NRC also received several that allows for the naming of an ARSO solicit key stakeholder input on topics comment letters after the public on the license.

associated with the definition of an ME, comment period closed. The NRC was The commenters were supportive of including the requirements for reporting able to consider and respond to several the proposed removal of attestation and notifications of MEs for permanent of these comments. However, two requirements for the board-certified implant brachytherapy, and on other comment letters on the T&E individuals, and other changes to the medical issues that were being requirements for alpha and beta emitters attestation requirements that are considered in the proposed rulemaking. were submitted so late in the retained for individuals applying These workshops were initiated as a rulemaking process that it was not through the alternate pathway.

result of the Commission's direction to practical for the NRC to consider these The commenters were not supportive the NRC staff in the SRM to SECY comments in this rulemaking. of the proposed additional case work 0062, which specified that the staff For the ME criteria for permanent requirements for the radionuclides used should work closely with the ACMUI implant brachytherapy, the commenters primarily for their alpha emissions.

and the medical community to develop generally supported the activity-based They were concerned that the proposed ME definitions that would protect the criteria instead of the current dose- regulation has the unintended interests of patients. The Commission based criteria for the treatment site. The consequence of increasing the burden of also directed that these definitions commenters did not support the criteria the work experience requirement for should allow physicians the flexibility related to the dose to normal tissues those seeking to administer therapeutic to take actions that they deem medically located outside the treatment site, and radiopharmaceuticals such as alpha and necessary, while preserving the NRC's normal tissues located within the beta emitters. They indicated that it may ability to detect misapplications of treatment site. The commenters also prove too burdensome for certain radioactive material and failures in expressed concern with the proposed 5 practitioners, particularly those in areas processes, procedures, and training. The cubic centimeter volume of the normal far removed from teaching hospitals and panelists for the workshops included tissue specification for the absorbed urban centers, to participate in three

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33055 proctored cases in each of these specific in the Proposed Rule, under §§ 35.41 Compatibility Category B designation categories. They stated that the result and 35.3045. for uniformity of practice and will be to limit patient access to these procedures among their different ii. Implementation Period safe and effective pharmaceuticals locations. A Compatibility Category B among what is already a disadvantaged The NRC asked whether a 180-day designation is for those program population. effective date for the final rule is elements that apply to activities that With regard to the proposed reporting sufficient to communicate the changes have direct and significant effects in and notification of failed Mo-99/Tc-99m to all practitioners and for practitioners multiple jurisdictions.

and Sr-82/Rb-82 generators in § 35.3204, to revise procedures, train on them, and During the development of the the commenters stated that the 30-day implement the changes. Three proposed rule, the OAS expressed a deadline to report should be shortened commenters responded to this question. strong desire to retain a dose-based ME to more effectively address patient One commenter stated that 180 days is reporting criterion for the treatment site safety concerns. In response to this sufficient to implement the rule. if NRC regulations are revised to include comment, the final rule has been However, two commenters stated that only activity-based criteria for changed to require a 7-calendar-day 365 days or more is needed to determining MEs for permanent implant reporting and notification time for a implement significant changes related to brachytherapy. The OAS had no failed generator. the dose evaluation requirements objection to the introduction of the proposed for the ME criteria portion of activity-based criteria, as long as the B. Public Comments and NRC the rule. Two commenters also dose-based criteria could be retained by Responses recommended that the amendments the Agreement States. With a The NRC carefully considered the related to PRM-35-20 should be Compatibility Category C designation, public comments in developing the final implemented immediately, or in no some Agreement States indicated they rule. This section summarizes the more than 30 days. Because the ME could require both the dose-based comments that the NRC received on the criteria related to the dose evaluations criterion and source-strength based proposed rule and provides responses to to normal tissues are removed in the criterion, as long as the Agreement State these comments. Part I discusses the final rule, the NRC determined that 180 reports to the NRC using the reporting specific comments received on the days is sufficient to implement the final criteria that meets the essential issues on which the NRC specifically rule. objectives of the NRC regulatory requested comments and discusses the requirements. As discussed in the iii. Impact on Clinical Practice proposed rule published on July 21, NRC's responses to these comments.

Part II discusses comments received on The NRC asked if any of the changes 2014, for some Agreement States, the specific sections of the 10 CFR part in the proposed rule are likely to Compatibility Category B is difficult to 35 amendments in the proposed rule discourage licensees from using certain achieve because their regulations must and the NRC's responses to these therapy options or otherwise adversely also meet specific state requirements comments. impact clinical practice, and if so, how. based on the state agencies in which the The NRC received several comments radiation control regulators reside. Also, Part I Public Comments on the on this issue. The comment summaries Agreement States may have existing Specific Issues on Which the NRC and NRC responses to comments on this laws requiring the collection of Requested Comments issue are discussed in Part II, Comments additional information on medical In the proposed rule, the NRC on Specific Sections in the Proposed diagnostic and therapy procedures.

requested comments on the following Rule, under §§ 35.390 and 35.396. If the level of compatibility for specific issues: § 35.3045 were to be raised to iv. Compatibility Category for the Compatibility Category B, Agreement

i. Dose-Volume Specification for Agreement States for § 35.3045, Report State requirements would need to be Determining Absorbed Dose to Normal and Notification of a Medical Event essentially identical to those of the NRC.

Tissue for MEs Under § 35.3045, Report Currently § 35.3045, Report and Compatibility Category B is applied to and Notification of an ME notification of a medical event, is requirements that have significant direct The NRC asked whether, in defining designated as Compatibility Category C transboundary health and safety MEs, the proposed volume of 5 for the Agreement States. This implications.

contiguous cubic centimeters dose- designation means that the essential The ACMUI in its report to the NRC volume specification for an absorbed objectives of the requirement should be (Enclosure 4 to SECY-13-0084) dose to normal tissue located both adopted by the State to avoid conflicts, recommended that MEs related to outside and within the treatment site is duplications, or gaps. The manner in permanent implant brachytherapy be appropriate. The NRC also asked which the essential objectives are designated as Compatibility Category B.

whether the application of the proposed addressed in the Agreement State The ACMUI was concerned with the ME definition for normal tissue based requirements need not be the same as proposed designation as Compatibility on the absorbed dose to the maximally NRC requirements, provided the Category C, which would allow the exposed 5 contiguous cubic centimeters essential objectives are met. Under Agreement States to retain the dose-during permanent implant Compatibility Category C, Agreement based criteria for an ME for permanent brachytherapy is appropriate for all States may require the reporting of MEs implant brachytherapy. The ACMUI potential treatment modalities, or with more restrictive criteria than those asserted that a Compatibility Category C whether it may result in unintended required by the NRC if they do not would continue to result in clinically consequences for tissues or organs create a conflict, duplication or gap with insignificant occurrences being adjacent to the treatment site. the essential objectives of the regulation. identified as MEs by Agreement States The NRC received numerous Some medical licensees have multiple and thereby perpetuate the confusion comments on this issue. The comment locations, some of which are NRC- associated with the current dose-based summaries and NRC responses to regulated and some of which are criteria. The ACMUI stated that the most comments on this issue are discussed in Agreement State-regulated. Many of important component of the rationale Part II, Comments on Specific Sections these licensees would prefer a for conversion from dose-based to

33056 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations activity-based criteria is the failure of Agreement States questioned how a Agreement State programs for agreement dose-based criteria to sensitively and single medical incident at a single material with respect to protection of only specifically capture clinically facility can have "direct and significant public health and safety. Under significant MEs in permanent implant effects in multiple jurisdictions." They Compatibility Category C for reporting brachytherapy. further added that the Compatibility permanent implant brachytherapy ME's, The Commission, in the SRM to Category C designation has been the regulatory provision uses activity-SECY-13-0084, directed the NRC staff adequate for the reporting requirements based criteria to ensure the consistent to designate § 35.3045 as Compatibility for radiography, irradiator, and well reporting of significant events as MEs Category B in the proposed rule, which logging licensees who routinely work in across the country. Agreement States' was subsequently published on July 21, multiple jurisdictions. One Agreement use of dose-based criteria for these 2014 (79 FR 42410). The NRC State stated that the proposed activity- reporting requirements would not be specifically invited comments on the based ME reporting criteria should be compatible with this provision because appropriate compatibility category for added to the existing dose-based it conflicts with the essential objective ME reporting under § 35.3045. criteria, rather than replace it. The of this provision to maintain a The NRC received 19 comments on Agreement State stated that it would consistent national program for this issue. The medical community require licensees to apply both criteria, reporting MEs.

submitted ten comments in support of and only those MEs that meet the NRC's The NRC staff considered Compatibility Category B. The proposed activity-based criteria would Compatibility Category B for the ME Organization of the Agreement States be reported to the NRC.

(OAS), the Conference of Radiation criteria for permanent implant Based on these comments, and review brachytherapy in § 35.3045(a)(2), but Control Program Directors (CRCPD), and of the NRC's Management Directive 5.9 7 Agreement States submitted concluded that this designation is not "Adequacy and Compatibility of comments in support of Compatibility justified, because ME reporting, while Agreement State Programs," NRC staff Category C. The medical community important to the effective and orderly determined that ME reporting under commenters stated that some medical regulation of agreement material on a

§ 35.3045 should be designated as licensees practice at multiple locations, Compatibility Category C. Under nationwide basis, does not have some of which are NRC-regulated and significant direct transboundary Compatibility Category C, the some of which are Agreement State- Agreement States must adopt the implications. As a Compatibility regulated. These commenters stated that essential objective of the requirement to Category C regulatory provision, the a Compatibility Category B designation avoid conflicts, duplications, or gaps. Agreement States have the flexibility to would allow for uniformity of practice The essential objective of § 35.3045 is to include, for example, a shorter reporting and procedures across the country. They time, but the use of dose-based ME maintain a consistent national program stated that moving § 35.3045 from for reporting MEs. A consistent national reporting criteria for permanent implant Compatibility Category C to B is program for reporting MEs allows the brachytherapy would create conflicts appropriate and necessary. The NRC to identify trends or patterns, and inconsistencies with respect to the commenters from the medical identify generic issues or concerns, national reporting program. Therefore, community also stated that they recognize inadequacies or unreliability the NRC will not accept, under recognize that the Agreement States of specific equipment or procedures, Compatibility Category C, Agreement oppose a change in Compatibility and determine why an event occurred State use of dose-based criteria for Category, citing state legislative and whether any actions are necessary permanent implant brachytherapy ME requirements, the difficulty in changing to improve the effectiveness of NRC and reporting.

state regulations, and the fact that States Agreement State regulatory programs. The comment summaries and NRC do not perceive a problem with the The NRC has determined that responses on this issue are discussed in current dose-based definition. While the allowing Agreement States to use the Part II of this section, under § 35.3045.

commenters from the medical dose-based criteria in addition to the Part II Comments Received on the community appreciate these concerns, activity-based criteria for permanent Specific Sections in the Proposed Rule they believed these concerns are implant brachytherapy MEs in outweighed by the importance of having § 35.3045(a)(2) would create Section 30.34(g) Terms and Conditions a consistent definition throughout the inconsistencies in the national reporting of Licenses country to prevent confusion and program and disrupt the NRC and unnecessary reporting of otherwise Agreement States' ability to use the Comment: One commenter noted that medically acceptable events. They national program for reporting MEs for Tc-99m decays much faster than Mo-99, expressed concern that a Compatibility the purposes described above. As a therefore, every Tc-99m generator eluate C designation would allow Agreement result, the use of dose-base criteria will eventually exceed the regulatory States to implement unnecessarily more instead of activity-based criteria would limit. Because of this, the commenter expansive criteria that may classify create a conflict with the NRC's stated that the language in the proposed medically acceptable procedures as an essential objective of this regulatory rule text would require every eluate to ME. provision, which could impair the be reported. The commenter proposed The Agreement States, OAS, and effective and orderly regulation of revising the rule text in § 30.34(g) to CRCPD recommended that the agreement material on a nationwide clarify that the licensee would only compatibility designation for ME basis. report measurements of a Tc-99m reporting under § 35.3045 be designated The NRC staff concluded that the generator elution that exceeded the as Compatibility C. They argued that continued use of a dose-based criteria regulatory limits at the time of generator under Compatibility Category C the could: (i) Preclude a practice in the elution.

Agreement States would continue to national interest to have consistent Response: The rule text was modified have the flexibility to add additional reporting and notification standard; (2) in response to this comment. The NRC reporting terms (for example, shorter impair effective communication; and (3) agrees with the commenter that the timelines for reporting, or a requirement preclude an effective review or proposed rule text was not clear in to report diagnostic MEs). Several evaluation by the Commission and § 35.204(e) and has amended it to clarify

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33057 that the reporting requirements only the addition of the ophthalmic physicist RSO on a medical license must submit apply at the time of generator elution. will render the AMP obsolete because a preceptor statement. The new the primary role of the AMP is to provision in this rulemaking will only Section 35.2 Definitions support the medical uses under § 35.600 remove the preceptor attestation Issue 1: Definition of an Associate and certain uses under § 35.1000. The requirements for individuals who are Radiation Safety Officer proposed revision would not prohibit an certified by a board recognized by the Comment: One commenter agreed AMP from assisting the ophthalmic AU. NRC or Agreement States. Individuals with and supported the new definition seeking to be named as an RSO or ARSO Issue 3: Definition of a Preceptor of an Associate Radiation Safety Officer. under the alternate pathway will need Comment: One commenter agreed to submit a preceptor statement.

Response: The comment supports with and supported the new definition Comment: One commenter language in the rule; therefore, no of a Preceptor. recommended revising the rule text in response is required. Response: The comment supports § 35.24(b) to read, "These duties and Comment: One commenter stated that language in the rule; therefore, no tasks are restricted to the types of use some Agreement States are already response is required. for which the Associate Radiation Safety using the term Assistant Radiation Section 35.24 Authority and Officer is listed on the license as an AU, Safety Officer and suggested the NRC Responsibilities for the Radiation AMP or ANP, or has training in the allow the use of a term other than Protection Program radiation safety, regulatory issues and "Associate," such as "Assistant." The emergency procedures." The commenter commenter stated that this change Comment: One commenter asserted believed that this revision "would align would alleviate the workload required that ARSOs should not be named on a it with 30.50(d)."

to modify certain Agreement States' medical license but licensees should be Response: The NRC assumes the medical licenses. Another commenter allowed to name ARSOs in their commenter intended to reference requested that the terms Assistant and radiation programs. The commenter proposed § 35.50(d) not § 30.50(d). The Associate be used interchangeably. disagreed with the NRC's argument that ARSO must be listed on a license before Response: No change was made to the licensees are having a difficult time in being assigned duties and tasks as an rule text based on this comment. To naming an RSO due to an RSO not being ARSO. The individual may be assigned establish a clear regulatory requirement, able to sign a preceptor form. Further, tasks outside of the agreed upon list of the term Associate Radiation Safety the commenter stated that "[t]he NRC ARSO duties and tasks in order to Officer (ARSO) is retained. Although the and Agreement States are authorized to obtain additional T&E.

term Assistant RSO is used in some approve a proposed licensee's RSO The commenter's proposed text Agreement States, each Agreement State based upon their T&E without the would imply that the ARSO is listed on may require individuals to meet preceptor attestation." a license as an AU, AMP, or ANP. This different T&E standards to be named as Response: No change was made to the is not always the case. Further, as an Assistant RSO on a license. rule text based on this comment. The written in the proposed rule and in the Therefore, any individual whom an NRC maintained the provision to name rule text suggested by the commenter, Agreement State has designated as an ARSOs on medical licenses to avoid the regulations could have permitted the Assistant RSO is not recognized by the confusion between individuals named RSO to assign duties and tasks to the NRC and may not be recognized by on a license as opposed to individuals individual as the ARSO for which he or other Agreement States. The new working in a radiation program and to she was not fully qualified (i.e., assigned definition will establish clear and establish regulatory requirements for duties and tasks for a type of use for concise requirements that an individual training and experience. This will allow which he or she was not listed on the would need to meet in order to be the individual who is named as an license). Therefore, for clarification, the recognized as an Associate RSO by the ARSO to be recognized by Agreement NRC has revised the rule text in NRC and Agreement States. States and the NRC as an RSO or ARSO § 35.24(b) to read, "These duties and Issue 2: Definition of an Ophthalmic for the same medical uses on another tasks are restricted to the types of use Physicist license without resubmitting his or her for which the Associate Radiation Safety T&E documents. Officer is listed on the license."

Comment: One commenter asserted The ACMUI identified two issues Comment: Two commenters that there was not a sufficient need to with respect to securing an RSO's expressed concern that there is no clear create an ophthalmic physicist signature on a preceptor statement: guidance or a policy on the number of designation and that by doing so the There were not enough preceptors and licenses on which an individual could NRC will set a precedent for other some preceptors were not willing to sign be named as an RSO or an ARSO. One source-specific designations, rendering preceptor statements. Naming the commenter requested that the NRC the AMP obsolete. ARSOs on a license and permitting develop this policy or guidance. The Response: No change was made to the them to sign preceptor forms will other commenter recommended that the rule text based on this comment. The increase the number of individuals who NRC, Agreement States, ACMUI, and designation of an ophthalmic physicist may sign the preceptor forms. Changes the medical community work together is retained. Authorized Users who work to the attestation language will remove to develop guidance or a policy that can in remote areas may not have ready impediments for individuals who were be consistently applied across all access to an AMP to perform the not willing to sign the previous regulatory jurisdictions to establish the necessary calculations and other preceptor statements. These changes minimum amount of time an RSO or an activities outlined in the new § 35.433 will enhance opportunities for RSO ARSO listed on multiple licenses would to support the ophthalmic treatments. candidates. be required to spend at each licensed This rule change will make the The NRC disagrees with the comment facility.

procedure involving the use of Sr-90 that RSOs are approved based upon Response: No change was made to the sources for ophthalmic treatments their T&E without a preceptor rule text based on these comments.

available to more patients located in statement. Under current regulations, an Current NRC regulations do not limit remote areas. The NRC does not believe individual seeking to be named as an the number of licenses on which an

33058 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations RSO can be listed concurrently. Some The NRC considers Y-90 microspheres within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after implant Agreement States limit the number of to be manual brachytherapy sources; completion."

licenses on which an individual may be however, they have unique properties Response: The comment supports named as the RSO. The NRC regulations that prevent them from being regulated language in the rule; therefore, no do not impose any such limit. Rather, under all the provisions of § 35.400. response is required. However, the NRC the NRC evaluates, on a case-by-case Therefore, they are regulated under notes that the post-treatment WD has to basis, whether the proposed RSO would § 35.1000. Consequently, the new rule be completed before the patient leaves have sufficient involvement in the does not apply to the use of Y-90 the post-treatment recovery area.

program and if necessary, limits the microspheres. Comment: Two commenters number of licenses on which that RSO Comment: One commenter supported supported the proposal to allow is named. specification of a "before implantation" modification of the WD based on the and an "after implantation" assessment medical situation encountered by the Section 35.40 Written Directives as an excellent improvement from the physician during the permanent implant Comment: One commenter questioned current regulations. However, the brachytherapy procedure. One of the the phrase in § 35.40 (b)(6)(i): ". . . if commenter stated that defining the commenters noted that when appropriate, the expected absorbed "treatment site" is a concern for prostate modifications to the WD are medically doses to normal tissues located within procedures. The commenter noted that necessary, these modifications should the treatment site," and stated that the an AU may need to change the not constitute an ME.

term "appropriate" is very subjective. definition of the treatment site and Response: The comment supports The commenter also asked who decides intended doses to critical structures language in the rule; therefore, no if normal tissues are located within the based on intraoperative imaging results. response is required.

treatment site and if this is a clinical This could result in the evaluation for Section 35.41 Procedures for decision. The commenter was an ME for absorbed dose to normal Administrations Requiring a Written concerned that an inspector might tissue to be based on a condition that Directive determine appropriateness differently changed during the implant procedure.

than the licensee's AU or AMP, Response: The rule text was modified Comment: One commenter stated that resulting in a potential violation based in response to this comment. The rule the method and timing of the on a difference in interpretation. The text in § 35.40(b)(6)(ii) was changed to comparison in § 35.41(b)(6)(i) is unclear.

commenter believes that the WD should allow the AU to change the description The commenter noted that there is no not include expected doses to normal of the treatment site in the post- requirement to include in the post-tissues located within the treatment site implantation WD. The NRC agrees that implantation WD the number of sources because there may be clinical reasons an AU needs flexibility to change the implanted outside the treatment site.

for an AU to accept a higher dose to a definition of the treatment site based on The commenter believes that comparing normal structure in close proximity to the condition of the patient and imaging the total source strength implanted involved tissues. results obtained during the implant outside of the treatment site with the Response: The rule text was modified procedure. Further, based on other total source strength implanted inside based on this and other comments. The comments, the NRC removed the the treatment site is unreasonable NRC agrees that, for permanent implant requirements to include, in the WD, the because some sources may intentionally brachytherapy, the determination of the absorbed dose to normal tissue in be implanted outside the treatment site appropriate dose to normal tissue (if § 35.40(b)(6)(i). as defined in the pre-implantation WD.

any) located within the treatment site is Comment: One commenter stated that The commenter suggested rewriting this a matter of medical judgment. The NRC the after implantation WD requirement section to clearly specify that the has removed the reference to dose to in § 35.40(b)(6)(ii) is consistent with concern is errors in source placement, normal tissue located within the clinically relevant circumstances. not sources outside the treatment site.

treatment site. The rule text in However, the commenter believes that it Response: No change was made to the

§ 35.40(b)(6)(i) was modified to remove would be appropriate to list the number rule text based on this comment.

the requirement to include in the pre- of seeds purposely implanted outside Section 35.41(b)(6)(i) requires a licensee implantation WD the language "if "the prostate plus margin specified in to determine, within 60 days from the appropriate, the expected doses to the prescription," because this date the permanent brachytherapy normal tissues located within the information will be needed when implant was performed, the total source treatment site." determining an ME. strength administered outside of the Comment: One commenter stated that Response: No change was made to the treatment site compared to the total the wording of § 35.40(b)(6) refers to rule text based on this comment. The source strength documented in the post-

"permanent implant brachytherapy," AU defines the treatment site in the WD implantation portion of the WD. The AU but the remainder of the rule reads as if in the way he or she believes to be defines the treatment site (as defined in it was written for brachytherapy seeds. medically appropriate, including any § 35.2) in the WD in any way he or she The commenter noted that Y-90 margin. The AU may define the believes to be medically appropriate.

microspheres are sealed brachytherapy treatment site to include all tissues into The AU may define the treatment site to sources that are permanently implanted. which sources have been purposely include all tissues into which sources The commenter asked if the new rule implanted. will be purposely implanted. Therefore, may be used in place of the existing Comment: Two commenters the total source strength implanted in guidance for Y-90 microsphere use supported the requirement in unintended locations would be under § 35.1000. § 35.40(b)(6) for a two-part WD for compared with the total source strength Response: No change was made to the permanent implant brachytherapy, with documented in the post-implantation rule text based on this comment. The one part before implantation and a portion of the WD.

term "permanent implant second part after implantation. One Comment: One commenter stated that brachytherapy" is used to refer to commenter stated that "documentation it appears reasonable in theory to manual brachytherapy procedures of the number of sources and total determine absorbed dose to the performed in accordance with § 35.400. source strength is easily determined maximally exposed 5 contiguous cubic

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33059 centimeters of normal tissue. However, brachytherapy, including mesh treatment site and within the treatment the commenter believes that it will be procedures. The NRC retained this site. The NRC retained the requirement difficult to make this determination requirement because it is important to to determine the total source strength using current technology. The ensure that the use of the radionuclide administered outside of the treatment commenter stated that "planning is in accordance with the WD. site compared to the total source systems typically report dose-volume Comment: Several commenters stated strength documented in the post-histograms to structures, but they do not that they support the requirement for implantation WD. It is likely that most identify contiguous volumes." performing a post-implant dosimetric licensees will perform the Response: The rule text was modified evaluation of each permanent determination of total source strength based on this comment. The rule text in brachytherapy implant within 60 days. administered outside of the treatment

§ 35.41(b)(6) was modified to remove However, there may be other obstacles site by performing an imaging study

§ 35.41(b)(6)(ii) and (iii). The NRC to meeting this 60-day requirement, such as a computed tomography scan. If acknowledges that while some beyond patient unavailability, that it is necessary to remove part of the treatment planning systems can identify should be added to the rule text. For tumor shortly after the implant, this contiguous volumes, others cannot. In example, one commenter noted that a imaging study may be performed before response to this concern and concerns machine may be broken and the facility the tumor removal.

raised by other commenters, the NRC may not have a backup, or the facility removed subparagraphs (ii) and (iii), may have lost electricity because of a Section 35.50 Training for Radiation which would have required the licensee storm. The commenters suggested Safety Officer and Associate Radiation to determine the absorbed dose to modifying the language in § 35.41(b)(6) Safety Officer normal tissues located both outside and to also allow written justification related Comment: One commenter agreed within the treatment site. to other factors "outside the control" of with the changes in the T&E Comment: One commenter the licensee. requirements for AUs, medical recommended modifying § 35.41(a) by Response: No change was made to the physicists, RSOs, and nuclear adding: "(3) After administration, an ME rule text based on these comments. A pharmacists. The commenter also as defined in § 35.3045 has not occurred 60-calendar-day time frame ensures that supported the establishment of the the licensee has ample time to make ARSO because they believe it provides Response: No change was made to the arrangements for the required a pathway for more individuals to be rule text based on this comment. The determination in § 35.41(b)(6). If the RSOs and increases the number of NRC determined that the recommended licensee's imaging device malfunctioned preceptors available for future RSOs and rule change is not necessary because or the facility lost electricity, it should ARSOs.

§ 35.41(b)(5) requires that at a be possible to refer the patient to Response: The comment supports minimum, the procedures required by another facility for the imaging study language in the rule; therefore, no

§ 35.41(a) include "[d]etermining if a within the 60-day time frame. Further, response is required.

medical event, as defined in § 35.3045, in response to other comments, NRC re- Comment: One commenter supported has occurred." evaluated the requirements for post- the inclusion of an ANP in the pathway Comment: Several commenters noted implant dosimetric evaluation to the to be identified as an ARSO on a that the proposed regulation would normal tissue and has removed this medical license.

apply to all permanent brachytherapy requirement. Response: The comment supports implants, including lung mesh Comment: One commenter believes language in the rule; therefore, no procedures. They stated that licensees that the assessment of permanent response is required.

do not routinely perform dose brachytherapy implants described in Comment: Several commenters assessments because the mesh is § 35.41(b)(6) should be part of the supported the removal of the preceptor visually sewn to the lung in the medical evaluation of the treatment and statement requirement for individuals prescribed location and the sources are not part of the procedures to provide who are certified by a specialty board not vulnerable to migration. The high confidence that the administration whose certification process has been commenters recommended excluding is in accordance with the WD. The recognized by the NRC or an Agreement lung mesh treatments from the commenter also noted the difficulty in State and are applying to be named as requirements of § 35.41(b)(6). meeting this requirement, if it is an RSO, ARSO, ANP, AMP, or AU.

Response: The rule text was modified retained, for permanent implants of Response: The comment supports based on this and other comments. The certain large tumors. In these cases, a language in the rule; therefore, no NRC recognizes the difficulty in surgical procedure to remove part of the response is required.

determining the absorbed dose to tumor may be performed shortly after Comment: One commenter supported normal tissues for treatments that use the implant and this may result in ARSOs being named on licenses and mesh material with permanent intentional removal of many of the being able to serve as preceptors.

brachytherapy sources incorporated into seeds. Post-implant removal of sources Response: The comment supports the mesh. In response to this concern will change the dose to normal tissues. language in the rule; therefore, no and those raised by other commenters, The commenter stated that the proposed response is required.

the NRC removed subparagraphs (ii) and regulation appears to require re-imaging Comment: One commenter stated that (iii) in § 35.41(b)(6), which would have to localize the remaining sources to the ARSO position created in the required the licensee to determine the perform the required assessment; proposed rule does not create a new absorbed dose to normal tissues located however, it is unlikely that this pathway for an individual to become an both outside and within the treatment additional assessment was intended. RSO. The commenter proposed that the site. The NRC retained § 35.41(b)(6)(i) to Response: The rule text was modified NRC create a new pathway for an determine the total source strength in response to other comments. The individual to qualify as an RSO by administered outside of the treatment NRC modified the rule text in relaxing the T&E requirements for an site compared to the total source § 35.41(b)(6) to remove the requirement ARSO. This new pathway would require strength documented in the post- to determine the absorbed dose to an individual to meet only the implantation WD for all permanent normal tissues located outside the education requirements in § 35.50 to be

33060 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations named as an ARSO and then participate would permit AUs to be RSOs. Doing so, that the text in paragraphs (c)(1) and (2) in a year-long training program. The according to the commenter, would included "similar types of use" whereas commenter's expectation was that, at weaken the position held by the RSO paragraph (c)(3) implies the exact same the end of the year-long training because a physician AU acting as the types of use.

program, the ARSO would have gained RSO is doing so as an additional duty. Response: The rule text was modified proficiency in each of the areas listed in The commenter asserted that these based on this comment. The NRC agrees the regulations and could work RSOs were neither familiar with the with the commenter that there should independently and be qualified to be an regulations nor the recordkeeping be consistency between the rule text in RSO. The commenter also proposed that requirements of a radiation safety § 35.50 (c)(1) and (2). The rule text in management would have the ARSO program. The commenter further stated paragraphs (c)(1) and (2) was changed to agree in writing to be responsible for that if they made a mistake as an AU, read "has experience with the radiation implementing the radiation protection it was often overlooked or corrected by safety aspects of similar types of use of program. simply re-writing a prescription for a byproduct material for which the Response: No change was made to the particular treatment. licensee seeks the approval of the rule text based on this comment. The Response: No change was made to the individual as the Radiation Safety ARSO position created in the proposed rule text based on this comment. Officer or Associate Radiation Safety rule does create a new pathway for an Current regulations recognize an AU as Officer." However, a similar change was individual to become an RSO. An ARSO being qualified to be an RSO consistent not made to the rule text in § 35.50(c)(3).

can become an RSO for the same types with the AU's authorization and The provisions in § 35.50(c)(3) only of use of byproduct material for which required radiation safety experience. address a new license application where he or she was assigned duties and tasks This provision was unchanged in this the applicant is requesting that a as an ARSO on a medical license. This rulemaking. The NRC expects that all qualified individual, who has not new pathway requires the same T&E for AUs/RSOs take their responsibilities previously been named on a license, be ARSOs as the current regulations for and obligations seriously and notes that named as both an AU and the RSO on individuals seeking to be an RSO. AUs/RSOs should not overlook or the new license. The new license will The commenter proposed adding a "correct" errors by "simply re-writing a authorize only those types of uses for pathway for an individual to qualify as prescription for a particular treatment." which the proposed AU/RSO has T&E.

an RSO via the ARSO position. This Comment: Several commenters Comment: One commenter sought proposed pathway is problematic opposed having an ARSO provide a clarification on whether § 35.50(c)(3) because it would create a training preceptor attestation for an individual applied to a new license with just one program for an individual to become an seeking to be named as an RSO. The potential AU. The commenter believes ARSO without the individual meeting commenters stated that an ARSO is only that license reviewers would use all the required T&E for an ARSO or an responsible for certain duties or limited paragraph (c)(3), as written in the RSO. The NRC does not intend for this sections of the program while the RSO proposed rule, to add the first AU/RSO rule to create a training program for an is responsible for the entire radiation and then process a separate licensing individual to become an ARSO who is safety program. One commenter further action to add other AUs.

not fully qualified to be an RSO. The recommended that an ARSO should Response: The rule text was modified NRC did not include a provision to only be permitted to provide a preceptor based on this comment. The NRC's require management to have the ARSO statement for an individual seeking to intent in the proposed rule was for the agree in writing to be responsible for be named as an ARSO. provision in § 35.50(c)(3) to apply to a implementing the radiation safety Response: No change was made to the single physician applicant who was not program because the RSO is responsible rule text based on these comments. For yet authorized to be an AU and has for the radiation safety program. The each medical use for which an ARSO is requested to be both the AU and RSO.

RSO may delegate tasks and duties to authorized, the T&E requirements are Based on the comment, the NRC has the ARSO but the final rule at § 35.24(b) the same as that of an RSO. Further, the broadened the provision in § 35.50(c)(3) states that the RSO "shall not delegate requirements for the preceptor are the to include an applicant for a new the authority or responsibilitiesfor same, regardless of whether they are an medical use license with multiple AUs implementing the radiationprotection RSO or an ARSO. Therefore, an ARSO who requests an individual, qualified program." can be a preceptor for a potential RSO but not yet recognized to be an AU, to Comment: Two commenters or a potential ARSO, but only for those be both an AU and the RSO on the new recommended relaxing the uses for which the preceptor ARSO is license.

qualifications for the ARSO to allow on- authorized. Comment: One commenter asserted the-job training while serving in an Comment: Two commenters that the provisions in § 35.50(c)(2) were assistant or associate position. recommended that AUs, ANPs, or AMPs all that were needed in a rural setting to Response: No change was made to the be allowed to serve as RSOs on appoint an individual as both an AU rule text based on these comments. The individual licenses for private practices and an RSO simultaneously, and commenters' proposal would have (i.e., non-hospital sites). § 35.50(c)(3) was not needed, unless resulted in recognition of an individual Response: No change was made to the § 35.50(c)(3) individuals are not subject as an ARSO when the individual had rule text based on these comments. The to the requirements in § 35.50(d).

not satisfactorily completed all the current regulations already allow AUs, Response: The rule text was modified training and experience qualifications to AMPs, and ANPs to serve as RSOs on based on this comment. For clarity, the perform his or her duties and tasks and private practice licenses and other non- rule text was revised to add a reference could be recognized as an RSO at a later hospital medical facilities. to § 35.50(d) in § 35.50(c)(3) based on date. An ARSO may receive additional Comment: One commenter requested both this and another comment. The on-the-job training to expand his or her that the rule text in § 35.50(c)(1), (2), provisions in § 35.50(c)(3) are distinctly training and skills to apply for ARSO and (3) be consistent with respect to the different from the provisions of status for additional types of use. description of the radiation safety § 35.50(c)(2) and both can be used in Comment: One commenter asserted experience and types of use to avoid rural areas. Section 35.50(c)(3) that the changes to the regulations confusion. The commenter pointed out addresses only a new license where the

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33061 physician whom the applicant is reads "Except as provided in 35.57, the either the individuals seeking ARSO requesting to be named as an RSO has licensee shall require an individual... listing/approval or the licensees.

not yet been listed on a license as an to be an individual who- . .. (c)(3)." Response: No change was made to the AU. Section 35.50(c)(2) applies to a new Additionally, because the individual Compatibility Category for the ARSO application or amendment to an existing has not yet been identified as an AU or training and experience requirements.

license where the applicant or licensee RSO, the individual does not yet have The NRC has determined that § 35.50 is is requesting to identify an individual the responsibilities of an RSO. a Compatibility Category B because T&E already identified as an AU, AMP, or Comment: One commenter stated that requirements have "significant direct ANP on a license or permit as the RSO. the ARSOs should be fully trained to transboundary implications." Assistant The individuals who meet the manage the radiation safety program RSOs might not meet the requirements requirements in § 35.50(c)(2) or (c)(3) issues for all modalities authorized on to be an ARSO. Therefore, they may not must also meet the requirements in the license. This would simplify the be automatically listed as an ARSO on paragraph (d) of this section. license in that specialty areas of use a license. Individuals named as assistant Comment: One commenter stated that would not have to be listed and RSOs on a state license may continue to the provisions in § 35.50 in the amendments would not be needed for work as an assistant RSO on that proposed rule could be interpreted two changes to ARSO specialty areas. The license, but will be required to meet the ways. Due to the word "and" between ARSO would be ready to replace the requirements in §§ 35.50 and 35.51 if

§ 35.50(c)(3) and § 35.50(d), the RSO with only the delegation of they would like to be named as an provision in § 35.50(d) could be authority letter from management ARSO.

interpreted to apply to § 35.50(c)(3). needed to qualify the ARSO as RSO. Comment: Two commenters Alternatively, the provision in Response: No change was made to the supported the establishment of an

§ 35.50(d) could be interpreted not to rule text based on this comment. ARSO, but the commenters believed the apply to § 35.50(c)(3). The commenter Limiting the ARSO designation to only NRC overemphasized the need to stated that a revision is necessary to those individuals that have T&E in all provide more preceptors. The clarify whether or not paragraph (d) the medical types and uses on the commenters stated that the more applies to (c)(3). The commenter also license would not permit individuals important reason for establishing an stated that if paragraph (d) does not with T&E for some of the medical types ARSO is to recognize more qualified apply to § 35.50(c)(3), this pathway of use on the license to be recognized individuals and increase the pool of would permit a large institution as ARSOs. The NRC disagrees with the RSOs. One of the commenters further applying for a new license to have an stated that many states have had ARSOs commenter's assertion that the RSO that did not demonstrate individuals should be trained for all or similar individuals or multiple RSOs compliance with § 35.50(d). on a license for many years and this has modalities so that they could be ready Response: The rule text was revised not caused problems.

to replace the RSO. A trained individual based on this comment. The rule text Response: No change was made to the is not necessarily qualified to be the was revised to add a reference to rule text based on these comments. The

§ 35.50(d) in § 35.50(c)(3). The NRC RSO; the individual would also need to NRC recognizes that the increase in the agrees that § 35.50(d) applies to meet the experience requirements.

number of individuals meeting the

§ 35.50(c)(3). Although the NRC Additionally, the NRC disagrees with qualifications in § 35.50 and being intended to provide a pathway for a the commenter's assertion that only a recognized as ARSOs both increases the single practice physician, if a medical delegation of authority letter is needed number of individuals recognized as institution wants to apply for a Part 35 for the ARSO to become an RSO. Only meeting the qualifications for being medical use license by adding a a regulator can name an individual as RSOs and the number of available physician (who is qualified but not yet the RSO on a license.

preceptors. The NRC continues to authorized as an AU) to be both an AU Comment: One commenter agreed require under § 35.24(b) that only one and the RSO, then the institution could with the proposed addition of ARSOs RSO be listed on each medical use also use the provisions of § 35.50(c)(3) but requested a requirement that the license because that is the individual to obtain a medical use license. Note ARSO's performance and level of responsible for the day-to-day oversight that once a hospital has obtained a activity be reviewed on an annual basis of the entire radiation safety program.

medical use license, the provisions of by the licensee's RSO or Radiation

§ 35.50(c)(3) no longer apply because Safety Committee. The commenter Section 35.55 Training for an they only apply to new licenses. believed this would ensure that only the Authorized Nuclear Pharmacist Comment: One commenter stated that active ARSOs with recent experience Comment: One commenter asserted the rule text in § 35.50(c)(3) appeared to are listed on the license. that specialized residencies in be "backward" and suggested that the Response: No change was made to the pharmacy practice are available and paragraph should read "Is an individual rule text based on this comment. The more are emerging, including nuclear who is seeking simultaneous approval requirement in § 35.14(b) for a licensee pharmacy practice residency programs.

both as the Radiation Safety Officer and to notify NRC no later than 30 days after The commenter provided a website for the AU on the same new Commission or an ARSO permanently discontinues the American Society of Health-System Agreement State license and who has performance of duties as an ARSO is Pharmacists residency directory, which experience with the radiation safety adequate without adding a prescriptive contains an online directory of aspects of the types of use of byproduct requirement to annually review the pharmacy residency programs, in material for which the individual has performance of the ARSO. support of this assertion. The Radiation Safety Officer Comment: One commenter believed commenter recommended amending responsibilities." the T&E of the ARSO should be § 35.55(b)(2) to read:

Response: No change was made to the designated as Compatibility Category Has obtained written attestation that the rule text based on this comment. "C." This would give the state program individual has satisfactorily completed the Starting the paragraph with "Is an the flexibility to more effectively requirements in paragraph (b)(1) of this individual who..." would result in monitor the roll out of this new section and is able to independently fulfill redundant language because § 35.50 provision without adversely affecting the radiation safety-related duties as an

33062 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations authorized nuclear pharmacist. The requirements and concurs with the situation is unique, the applicant's attestation must be obtained from either: (i) attestation provided by the program director. submitted documentation will need to A preceptor authorized nuclear pharmacist The nuclear pharmacy training program must be evaluated on a case-by-case basis.

who meets the requirements in §§ 35.57 or be part of a College or School of Pharmacy Comment: One commenter stated that 35.55, or equivalent Agreement State that is accredited by the Accreditation requirements; or (ii) A residency program the proposed additional dosage category Council for Pharmacy Education.

director who affirms in writing that the at § 35.390(b)(1)(ii)(G)(4) for the medical attestation represents the consensus of the This recommended amendment would use of alpha-emitting radionuclides residency program faculty where at least one permit program directors of these such as Radium-223 dichloride would faculty member is an authorized nuclear programs to sign the preceptor result in an unintended consequence.

pharmacist who meets the requirements in statement when certain conditions, Specifically, an AU currently authorized

§§ 35.57 or 35.55 or equivalent Agreement similar to the medical residency criteria, to use Radium-223 dichloride would be State requirements and concurs with the are met. The commenter also stated that required to have additional work attestation provided by the residency the nuclear pharmacy training program program director. The residency training experience to be authorized for program must be approved by the must be part of a College or School of parenteral use of radiopharmaceuticals Commission on Credentialing of the Pharmacy and accredited by the used primarily for their alpha-emitting American Society of Health-System Accreditation Council of Pharmacy characteristics under Pharmacists and must include training and Education. § 35.390(b)(1)(ii)(G)(4). The commenter experience specified in § 35.55(b)(1). Response: No change was made to the requested that, if the NRC retained the The recommended amendment would rule text based on this comment. The additional proposed dosage category, add provisions that would allow the regulations permit a pharmacist to be that the NRC amend the date in residency program director to provide recognized as an ANP as long as the § 35.57(b)(1) and (2) from October 24, an attestation to the T&E requirements § 35.55 T&E requirements are met. 2005, to December 31, 2014, or a later for an ANP similar to those provisions Therefore, if the pharmacist receives his date, to grandfather such individuals.

added for an AU, AMP, and RSO. or her training from a nuclear pharmacy Response: The rule text was modified Response: No change was made to the training program in a college or school based on a recommendation from the rule text based on this comment. The of pharmacy that meets this criterion, ACMUI. The effective date of the NRC reviewed the American Society of the pharmacist can be recognized as an grandfathering provisions in the rule Health-System Pharmacists residency ANP. The NRC has not had an text in § 35.57(b)(1) is changed from directory at the provided website. The opportunity to evaluate the October 24, 2005, to the effective date of residency directory included residency Accreditation Council of Pharmacy the rule. The commenter is correct that, programs in the United States and two Education's nuclear pharmacy as proposed, the rule text would not foreign countries. The website lists only educational programs, and to do so permit an AU currently administering one nuclear pharmacy residency would be beyond the scope of this Radium-223 dichloride to be authorized program in the United States. Other rulemaking. The commenter may submit to use it after the effective date of the residency programs included in Part 35 its recommendation to the NRC as a rule, and that was not the intent of the have been accredited by either the petition for rulemaking under § 2.802. NRC. The final rule grandfathers all AUs Residency Review Committee of the authorized for medical uses, including Section 35.57 Training for Radium-223 dichloride, on the effective Accreditation Council for Graduate Experienced Radiation Safety Officer, Medical Education, the Royal College of date of the rule to continue to be able Teletherapy or Medical Physicist, to administer it after the rule becomes Physicians and Surgeons of Canada, or Authorized Medical Physicist, the Council on Postdoctoral Training of effective without needing to reapply for Authorized User, Nuclear Pharmacist, authorization under the new the American Osteopathic Association. and Authorized Nuclear Pharmacist The Commission on Credentialing of the requirements in §§ 35.390 or 35.396.

American Society of Health-System Comment: Several commenters However, no change was made to the Pharmacists has not been evaluated by supported the revision of § 35.57 to rule text in § 35.57(b)(2) because this the NRC to determine if this recognize individuals certified by the section pertains only to those accreditation group is equivalent to the boards named in the previous Subpart J individuals certified by boards of 10 CFR part 35 for the modalities that recognized in Subpart J.

accreditation groups listed above, and to they practiced on or before October 24, Note that § 35.390(b)(1)(ii)(G)(4) was do so would be beyond the scope of this 2005. deleted and provisions within that rulemaking. Therefore, the nuclear Response: The comment supports section have been incorporated within pharmacy residency program has not language in the rule; therefore, no § 35.390(b)(1)(ii)(G)(3) based on other been included in this rulemaking. The response is required. comments. Therefore, the category commenter may submit its "parenteral administration of any Comment: One commenter requested recommendation to the NRC as a clarification on the type and extent of radioactive drug that contains a petition for rulemaking under § 2.802.

documentation an individual will need radionuclide that is primarily used for Comment: One commenter to produce to demonstrate that he or she its alpha radiation characteristics, for recommended that the NRC recognize was practicing certain modalities prior which a written directive is required" is structured nuclear pharmacy training to 2005 in order to meet the now included in § 35.390(b)(1)(ii)(G)(3).

programs, sometimes referred to as requirements in § 35.57. After reviewing the ACMUI final certificate programs, by amending Response: No change was made to the recommendations on the revised part 35

§ 35.55(b)(2) to provide: rule text based on this comment. The rule, the NRC has determined that an (iii) A program director of a structured NRC provides T&E guidance in NUREG- additional three cases of administering nuclear pharmacy training program who 1556, Vol. 9 "Consolidated Guidance dosages of radioactive drugs for alpha-affirms in in [sic] writing that the attestation about Materials Licenses: Program- emitting radiopharmaceuticals for represents the consensus of the training program faculty where at least one faculty Specific Guidance about Medical Use parenteral administration is not member is an authorized nuclear pharmacist Licensees." This NUREG provides necessary.

who meets the requirements in §§ 35.57 or information for meeting the Comment: Two commenters support 35.55, or equivalent Agreement State requirements in § 35.57. Because each the concept of grandfathering the RSO,

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33063 medical physicist, teletherapy physicist, procedures] covered by their board Response: No change was made to the AMP, AU, nuclear pharmacist, and certification." rule text based on these comments. The ANP. However, the commenters stated Comment: Two commenters NRC is retaining the board certification that the date of certification does not supported the revisions to § 35.57 with dates for all boards recognized under have an impact on an individual's respect to the Ritenour Petition. the requirements in 10 CFR part 35.

qualifications to perform the duties of However, the commenters stated that This is because the boards change their an RSO and they do not agree with the preceptor statements should not be certification processes; no longer certify limiting the grandfathering provisions to required for those individuals individuals for life; and, in some cases, "those materials and uses that these requesting to be grandfathered under the only guarantee the certification status individuals performed on or before provisions of § 35.57. for a few years requiring verification of October 24, 2005." The commenters Response: No change was made to the the current certification status of its believe the continuing education rule text based on these comments. The diplomates. Further, the NRC does not requirements for periodic certification revised rule text in §§ 35.50, 35.51, require reporting of the board renewal assures that the individual 35.55, 35.190, 35.290, 35.390, 35.392, certification status of an individual remains qualified. Thus, all board 35.394, 35.490, 35.590, and 35.690 also associated with an ME or a violation of certified individuals, regardless of the applies to board-certified individuals NRC requirements.

date of their initial certification, are under § 35.57 and does not require preceptor statements for individuals Section 35.65 Authorization for equally qualified to be named as an RSO Calibration, Transmission, and or ARSO and that the initial who are qualified to be authorized under the board certification T&E Reference Sources certification date is immaterial to one's present technical expertise. requirements. Comment: One commenter noted that Comment: Two commenters requested the explanation for the proposed Response: No change was made to the that individuals meeting the board changes for § 35.65 in the Federal rule text based on these comments. The certification requirements in Register notice stated that there were board certification pathway includes not

§ 35.57(a)(2), (a)(3), and (b)(2) must be two new paragraphs whereas the text only the requirement to be certified but immediately grandfathered because the contained three new paragraphs.

also that the individual has training in Response: The NRC agrees with the NRC failed to respond to the Ritenour the radiation safety, regulatory issues, commenter's observation.Section VI, Petition in a timely manner. Further, the and emergency procedures for the types Section-by-Section Analysis, of this commenters stated that these of use for which the licensee seeks individuals should not have to fulfill document indicates that three new approval. That is why the the burdensome "alternate pathway" or paragraphs were added to § 35.65.

grandfathering provisions for the RSO preceptor attestation if they wish to Comment: One commenter stated that include the phrase "those materials and become authorized on a license, but the transmission sources should be uses that these individuals performed have not been so named by an NRC or removed entirely from §§ 35.65 and on or before October 24, 2005." The Agreement State license. 35.500 and should be placed in NRC retained the date of October 24, Response: No change was made to the § 35.200. Additionally, the commenter 2005, because that was the expiration rule text based on these comments. The stated that the use of spot markers/

date of the prior T&E requirements NRC recognizes that individuals may anatomical markers should be added to (Subpart J). not have been listed on a license but § 35.200 because they are used on Comment: Several commenters were practicing certain modalities on or patients and are not used for instrument supported the grandfathering of board- before October 24, 2005. Individuals calibration purposes. The commenter certified individuals but requested the meeting the board certification explained that transmission sources, rule text be changed from "for the requirements in § 35.57 have to provide unlike sources currently in § 35.500, are modalities that they practiced on or evidence that they practiced the not used to render a diagnosis and are before October 24, 2005," to the modalities for which they are seeking not consistent with that category of use.

ACMUI-recommended language "for the authorized status and may also have to The commenter agreed with the NRC uses [or procedures] covered by their provide evidence of continuing that materials authorized by § 35.65 board certification on October 24, education and experience if it has been should be prohibited for human use but 2005." These commenters stated that more than 7 years since their went further to say that sources the ACMUI language would eliminate certification. Individuals being authorized by § 35.65 should be limited any potential uncertainty concerning grandfathered under the provisions of to only non-human use including what the term "practiced" means. § 35.57(a)(2), (a)(3), and (b)(2) do not calibration and reference sources for Response: No change was made to the need preceptor attestations and do not instrument/equipment calibration and rule text based on these comments. In need to meet the training requirements testing. The commenter further the Ritenour Petition, the petitioner of the alternate pathway. recommended that the text proposed in requested that the NRC grandfather Comment: Two commenters requested § 35.500 should be edited and moved to individuals certified by boards listed in that the NRC consider removing dates § 35.200.

Subpart Jfor the modalities that they from the board certification Response: No change was made to the practiced as of October 24, 2005. requirements for the currently rule text based on this comment. The Further, the board certification pathway recognized boards, as well as the boards final rule clarifies that some sealed includes not only the requirement to be affected by the Ritenour Petition. They sources authorized under § 35.65 may certified but also that the individual has based the request on their assertion that be used under both §§ 35.65 and 35.500.

training in the radiation safety, there has not been any evidence of an Furthermore, sources that meet the regulatory issues, and emergency ME or regulatory violation before 2005 § 35.65 criteria are not required to be procedures for the types of use for or since that has demonstrated, or even listed on a license when they are used which the licensee seeks approval. suggested, that the year of board under the provisions of § 35.500. The Therefore, it is necessary to identify the certification has any association with NRC considers the use of a transmission modalities that the individual better or worse regulatory compliance or source to be diagnostic medical use performed and not "the uses [or radiation safety. when a patient is exposed to its

33064 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations radiation. Additionally, § 35.200, which medical procedure, these uses are NRC concluded that these three authorizes the medical use of unsealed authorized under § 35.500. Possession of elements show the individual has the byproduct material, is not the the sources may be authorized under requisite knowledge and that an appropriate section for sealed sources. § 35.65, but medical use of the sources additional attestation is not necessary.

Comment: Several commenters stated is only authorized under § 35.500. For For the non-board certified applicants, that referring to § 35.500 in the example, a transmission source may be the attestation requirement is retained proposed rule text in § 35.65 was possessed under § 35.65, but can only be but the attestation language is revised in confusing. They recommended that the used as part of a medical diagnostic response to concerns that preceptors are phrase "except in accordance with the procedure under § 35.500. reluctant to sign preceptor attestations requirements in § 35.500" be removed due to personal liability concerns.

The Following Comments Were from § 35.65(b)(1). They stated that the Comment: Two commenters endorsed sources in § 35.65 do not need to be Common to the Training and Experience Requirements in Sections 35.51, 35.190, retaining the attestation requirement for listed on a license but the current those individuals pursuing initial board 35.290, 35.390, 35.392, 35.394, 35.396, regulation in § 35.500 requires that certification (but not yet certified) and sources and users be listed on a license. 35.490 and 35.690 alternate pathways. The commenters Furthermore, the commenters stated Comment: Several commenters agreed stated that retaining the preceptor that sources in § 35.65 are to be used for with the NRC's proposal to remove the attestation helps ensure accountability reference, transmission, and calibration, preceptor attestation requirements for and credibility by clearly identifying an but sources in § 35.500 are to be used for individuals seeking authorized status AU who can attest that the individual diagnosis. via the board certification pathway. has satisfactorily completed the Response: No change was made to the Response: The comment supports required NRC training.

rule text based on these comments. The language in the rule; therefore, no Response: The comment supports rule text was not changed because response is required. language in the rule; therefore, no removal of the phrase "except in Comment: Several commenters agreed response is required.

accordance with the requirements in with the proposed change to the Comment: One commenter pointed

§ 35.500" would change paragraph (b)(1) attestation language from "achieved a out that the correct terminology for the to read that the byproduct material level of competency to function American Osteopathic Association authorized under § 35.65 would not be independently" to "verify that the residency approval organization is the permitted for medical use. For example, individual can independently fulfill the "Council on Postdoctoral Training."

removing this text would prohibit the radiation safety-related duties" for those Response: The rule text was modified use of a transmission source when a individuals applying through the based on this comment. The rule text is patient is exposed to its radiation, alternate pathway. They further stated changed to replace the "Committee on which is a diagnostic medical use. that the term "competency" has certain Post-Graduate Training" with the phrase Comment: One commenter noted that implications and liabilities in the "Council on Postdoctoral Training."

it listed transmission sources and medical domain that should not factor Comment: One commenter supported transmission source devices on medical into an attestation statement, which is permitting residency program directors use licenses. It was "unaware of any meant to assure regulators that the to provide attestations based on the circumstances in which a licensee individual received an adequate amount consensus of the residency faculty.

bundled sources currently authorized by of radiation safety-specific T&E. Response: The comment supports 35.65 (individual source activity limit) Response: The comment supports language in the rule; therefore, no in aggregation that are not listed or language in the rule; therefore, no response is required.

approved in the SS&D registry." The response is required.

Comment: One commenter commenter stated "that the proposed Comment: One commenter noted that recommended that the NRC recognize rule should be modified to clearly based on the revision to the T&E the Nuclear Medicine Advanced distinguish authorization for medical requirements, an individual who is Associate (NMAA) position as an AU for use and instrument calibration." board certified will no longer need a

§ 35.100 and § 35.200 medical uses. The Response: No change was made to the preceptor attestation to become an AU commenter described the NMAA as a rule text based on this comment. The or AMP. Further, the commenter noted physician extender in Nuclear Medicine commenter noted correctly that that the argument for this change is that who has been trained at the master's licensees cannot use sealed sources in a some preceptors have been reluctant to level, tested, and board certified in manner inconsistent with the sealed attest due to concerns related to advanced nuclear medicine practice.

source and device registry (SSDR). The personal liability based on possible The commenter stated that:

SSDR does not prohibit the "bundling" future actions of the proposed AU or of sealed sources to create a greater AMP. The commenter stated that if [t]he nuclear medicine advanced associate source activity, but § 35.65 limits the someone truly has these reservations, prescribes and administers pharmacologic activity of each sealed source authorized there may be a good reason they are not and non-pharmacologic interventions under the direction of the supervising physician under this section. Some licensees have willing to sign off on the attestation. and, as indicated by patient profile and interpreted § 35.65 incorrectly to mean Response: No change was made to the diagnostic procedure as allowable by state that these sealed sources could be rule text based on this comment. The and federal statutes, which includes, but is bundled to create an aggregated source NRC believes that certification by a not limited to:

with a greater activity than is allowed. specialty board coupled with the 1. Perform pre-procedure requirements and The rule change makes it clear that the recentness of training requirements in interventions as may be required.

maximum activity authorized by § 35.65 § 35.59 and, as appropriate, the 2. Perform intra-procedure requirements as applies to all sealed sources whether requirements in §§ 35.50(d), 35.51(c), may be required.

used singularly or in a bundled 35.390(b)(1)(ii)(G), or 35.690(c) is 3. Perform post-procedure requirements as sufficient to demonstrate that the may be required.

configuration.

The NRC reviewed the rule language individual seeking authorization on a The commenter clarified that, as with and believes it is clear that when sealed license has met the T&E requirements in other physician extenders, i.e.,

sources are used as part of a diagnostic the board certification pathway. The physician assistants and nurse

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33065 practitioners, NMAAs are allowed to rulemaking. Moreover, before making intended for patient use must never prescribe substances that are allowed any such change, the NRC would need exceed the regulatory limits. Because under the scope of their practice, such to carefully consider the radiological safety of patients is paramount, as radiopharmaceuticals. The health and safety issues attendant to reporting any failure to the NRC and the commenter believes that this opens the such a change and consult with the distributor, which may also sometimes pathway for physician extenders in ACMUI. Although the commenter's be the manufacturer, allows for nuclear medicine to become authorized recommendation is outside the scope of determinations to be made and actions users, just as physician assistants and this rulemaking, the commenter may to be taken to prevent similar nurse practitioners are allowed to submit a petition for rulemaking on this occurrences. If any eluate measurement prescribe medications on behalf of their issue pursuant to § 2.802. exceeds the regulatory limit, the supervising physicians. The commenter generator should be removed from Section 35.204 Permissible believes that the training and practical service until the cause is determined.

Molybdenum-99, Strontium-82, and Comment: One commenter suggested experience of NMAAs creates ideal Strontium-85 Concentrations candidates for AUs and that the NMAA revising § 35.204(b) to remove the has met the qualifications required Comment: Several commenters agreed phrase "after receipt" in the proposed under § 35.200 to become AUs. The with the proposed changes to measure requirements to measure the eluate from commenter concluded that the NRC every elution. One commenter noted the generator in order to demonstrate should also recognize their board that the new elution requirements are compliance with the regulations certification (Nuclear Medicine already included in standards of because measuring the eluate after Technology Certification Board practice and manufacturer receipt of the generator is already (NMTCB)) under §§ 35.190 and 35.290. recommendations. implied.

Response: The comment supports Response: The rule text was modified The commenter recommended that language in the rule; therefore, no based, in part, on this comment. The NMAAs be added to the candidates for response is required. rule text was changed to delete "after authorized user for radioactive Comment: One commenter noted that receipt" in § 35.204(b). The previously byproduct materials use for uptake, Tc-99m decays much faster than Mo-99; dilution, excretion, imaging and proposed language could be subject to therefore, every Tc-99m generator eluate misinterpretation by the regulated localization and that their board will eventually exceed the regulatory community and, as suggested by the certification be added to NRC limit. Because of this, the commenter recognized boards. The commenter commenter, measuring the eluate after stated that the language in the proposed receipt of the generator is already proposed specific rule text to rule text would require every eluate to implied. Deletion of "after receipt" accomplish this. be reported. The commenter proposed more clearly describes the intent of this Response: No change was made to the revising the rule text in § 35.204(e) to change to the regulation that each and rule text based on this comment. The clarify that the licensee would only every eluate intended for medical use of comment is outside the scope of this report measurements of a Tc-99m each generator must be tested for rulemaking. Currently, an AU under generator elution that exceeded the breakthrough.

§ 35.190, "Training for uptake, dilution, regulatory limits at the time of generator and excretion studies," or § 35.290, Section 35.300 Use of Unsealed elution.

"Training for imaging and localization Response: The rule text was modified Byproduct Material for Which a Written studies," must be "a physician." An AU based on this comment. The NRC agrees Directive Is Required is defined at § 35.2 as "a physician, with the commenter that the proposed Comment: One commenter questioned dentist, or podiatrist..." and a rule text was not clear in § 35.204(e) and the statement about § 35.300 in the physician is defined as "a medical has amended it to clarify that the "Discussion of Proposed Amendments doctor or doctor of osteopathy licensed reporting requirements only apply at the by Section" in the Federal Register

• . . to prescribe drugs in the practice of time of generator elution. notice for the proposed rule. The medicine." AU recognition under Comment: One commenter stated that statement was that an AU may be

§§ 35.190 and 35.290 is currently on two occasions in the last 10 years its authorized for one or more of the limited to physicians because these T&E generator elution measurements specific categories described in requirements and board recognition exceeded the regulatory limit, but on § 35.390(b)(1)(ii)(G), but not for all criteria are premised on the high level subsequent elutions, the measurements unsealed byproduct material. The of education and training obtained by were below the limit. The Tc-99m from commenter specifically wanted to know medical doctors and doctors of these subsequent elutions was used for what other unsealed therapeutic osteopathy who are licensed to practice patients. The commenter recommended byproduct material is referenced and medicine. These T&E requirements are that the reporting requirement of why a trained and experienced AU not premised on the level of education § 35.204 be revised to require a licensee could not be authorized for all unsealed and training obtained by physician to report to the NRC and the therapeutic byproduct material.

extenders or assistants. These T&E manufacturer or the distributor of Response: No change was made to the requirements ensure that AUs use medical generators within 30 days when rule text based on this comment. Any byproduct material for medical "consecutive measurements on the same new unsealed byproduct material purposes in a way that is radiologically generator" exceed the limits specified in requiring a WD that is not specifically safe for workers, patients, and the § 35.204(a). addressed in § 35.390(b)(1)(ii)(G) would public. The change that the commenter Response: No change was made to the be regulated under the provisions of requests would require the NRC to rule text based on this comment. The § 35.1000. This allows the NRC to consider whether it is acceptable, from commenter suggested changing the evaluate each new radionuclide for a radiological health and safety regulation to require consecutive possible unsealed byproduct material standpoint, to permit physician measurements on the same generator to use and determine whether it falls extenders or assistants such as NMAAs exceed the regulatory limits before within the scope of § 35.390(b)(1)(ii)(G) to be eligible to become AUs. Such a reporting the failure. The ratio of Mo-99 or instead should be regulated under the change is outside the scope of this to Tc-99m measured in any eluate provisions of § 35.1000.

33066 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations Section 35.390 Training for Use of However, as stated in § 35.390(b)(1)(ii)(G)(4) because it would Unsealed Byproduct Material for Which § 35.390(b)(1)(ii)(G), any radioactive require physicians authorized for the a Written Directive Is Required drugs not specifically addressed in parenteral administration of radioactive Comment: One commenter suggested paragraph (G) would be regulated under drugs containing radionuclides used the elimination of the attestation the provisions of § 35.1000. primarily for their electron emitters or Comment: One commenter stated that for its photon energy of less than 150 requirement for physicians meeting the "alternate pathway" T&E criteria in § 35.390(b)(1)(ii)(G)(4) would require an keV to have additional work experience AU currently authorized under involving dosage administrations in a

§ 35.390(b) as was done for the "board

§ 35.390(b)(1)(ii)(G)(3) to administer minimum of three cases to attain AU certification pathway" under radium-223 dichloride to obtain status. The commenter pointed out that

§ 35.390(a).

additional work experience, unless under the proposed regulations, those Response: No change was made to the revisions are made to § 35.57. The seeking to administer both types would rule text based on this comment. The commenter stated that these physicians need work experience in a minimum of NRC is retaining the attestation do not need additional training to use six cases of administration, three with statement requirement for individuals materials for which they are already alpha emitters and three with beta authorized under the "alternate authorized. emitters. The commenter referenced the pathway" provisions. This is because it Response: The rule text was modified ACMUI recommendation not to separate is important to know that the individual based on a recommendation from the the parenteral administration of beta not only successfully completed the ACMUI. The NRC revised § 35.57(b)(1) and gamma-emitting T&E requirements but is also able to to grandfather physicians for those radiopharmaceuticals from the alpha-independently fulfill the radiation medical uses for which they were emitting radiopharmaceuticals. The safety-related duties of an AU. authorized prior to the effective date of commenter also stated that according to Comment: One commenter believed the rule. Also, the NRC deleted the ACMUI, the NRC staff has not the use of the word § 35.390(b)(1)(ii)(G)(4) and included "radiopharmaceutical" in the provided a compelling radiation safety radioactive drugs primarily used for justification for emission-specific T&E introduction section of their alpha characteristics in requirements.

§ 35.390(b)(1)(ii)(G) and the phrase "any § 35.390(b)(1)(ii)(G)(3). These changes Response: The rule text was modified radionuclide" in the parenteral ensure that physicians already using Ra- based on a recommendation from the administration regulations (i.e., 223 dichloride at the time the rule ACMUI. Section 35.390(b)(1)(ii)(G)(4)

§ 35.390(b)(1)(ii)(G)(3) or (b)(1)(ii)(G)(4)) becomes effective are permitted to was deleted and provisions within that was confusing and would permit the use continue use of the radioactive drug. section have been incorporated into of a radionuclide that is not a Comment: Several commenters § 35.390(b)(1)(ii)(G)(3). The category component of a radiopharmaceutical. questioned the purpose of the proposed "parenteral administration of any The commenter used the example of paragraph (c) in § 35.390 that applied radioactive drug that contains a yttrium-90 (Y-90) microspheres only to parenteral administrations. They radionuclide that is primarily used for containing the radionuclide Y-90. The questioned how a physician could be an its alpha radiation characteristics, for commenter recommended revising the AU under the provisions of § 35.390 which a written directive is required" is wording in § 35.390(b)(1)(ii)(G)(3) and without completing the 1-131 cases now included in § 35.390(b)(1)(ii)(G)(3).

(b)(1)(ii)(G)(4) to say, "Parenteral listed in § 35.390(b)(1)(ii)(G). The The NRC has determined that an AU administration of any radioactive commenters questioned whether who is authorized under drug. .... " paragraph (c) should be moved to § 35.390(b)(1)(ii)(G)(3) would not need Response: The rule text was modified § 35.396. three additional cases to administer based on this and other comments. The Response: The rule text was modified alpha-emitting radioactive drugs.

rule text was changed to include the based on these and other comments. Comment: One commenter believed phrase "radioactive drug that contains Section 35.390(c) was removed in the NRC's separation of categories in a" in § 35.390(b)(1)(ii)(G)(3). The NRC final rule because § 35.390(b)(1)(ii)(G)(3) § 35.390(b)(ii)(G)(3) and agrees that the proposed language could and (4) was merged into one category of 35.390(b)(ii)(G)(4) based on the primary be clearer. Additionally, based on a parenteral administrations of emission used for medical use was not recommendation from the ACMUI, the radioactive drugs in the final rule in the best approach. The commenter cited NRC deleted § 35.390(b)(1)(ii)(G)(4) and response to a recommendation from the Lutetium-177 as an example of a included radioactive drugs primarily ACMUI. Section 35.390(c) was no longer radionuclide with a significant gamma used for their alpha characteristics in needed with this revision in the final emitting branch with energy exceeding

§ 35.390(b)(1)(ii)(G)(3). rule. Section 35.390(b)(ii)(G) now has 150 keV. The commenter proposed the Comment: One commenter stated that three separate categories of radioactive distinction be based on the prevalence both the current and proposed drugs, and a proposed AU is evaluated of gamma emissions greater than 150 categories in § 35.390(b)(1)(ii)(G)(3) and and authorized for each category keV. The commenter's proposal was to (4) are confusing. The commenter asked separately. The NRC recognizes that modify § 35.390(b)(ii)(G)(3) to read, what the purpose is for specifying the individuals that are board certified or "Parenteral administration for which a 150 keV limit in category (3). The have completed the other T&E criteria written directive is required of any commenter stated that if there is a new under § 35.390 may not have completed radionuclide which emits a photon with use for a photon emission greater than their supervised work experience energy greater than 150 keV in less than 150 keV then there is no provision for administering all the categories of or equal to 10% of all decays, or of any it under the regulations. radioactive drugs in § 35.390(b)(1)(ii)(G). less than 1.0 GBq (27 mCi) of any other Response: No change was made to the These individuals will be authorized for radionuclide;" and modify rule text based on this comment. The only those categories for which they § 35.390(b)(ii)(G)(4) to read, "Parenteral NRC believes it is unlikely that there have completed their T&E. administration for which a written will be a radioactive drug requiring a Comment: Several commenters directive is required of 1.0 GBq (27 mCi)

WD that will be used primarilyfor its opposed the proposed new dosage or more of any radionuclide which photon energy greater than 150 keV. category for alpha emitters under emits a photon with energy greater than

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33067 150 keY in more than 10 percent of all an individualized T&E requirement radioactive drugs primarily used for decays." The commenter concluded that review, due to its administration profile their alpha characteristics in most, if not all alpha emitters, would be and safety characteristics. § 35.390(b)(1)(ii)(G)(3).

in the newly defined category 3 and be Response: No change was made to the Section 35.396 Training for the consistent with the placement of rule text based on this comment. The NRC's regulations under § 35.1000 allow Parenteral Administration of Unsealed radium-223 dichloride.

Response: No change was made to the the NRC to determine when a particular Byproduct Material Requiring a Written Directive rule text based on this comment. The medical use of byproduct material or commenter provided an alternative radiation from byproduct material Comment: One commenter supported approach for categorizing various should be regulated under § 35.1000. In changes in the proposed rulemaking to radioactive drugs for parenteral accordance with § 35.12(d), the NRC permit physicians who have completed administration, but the NRC believes will license a new radionuclide under the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and that the categorization is better § 35.1000 if it has unique properties that laboratory training specified in delineated based upon the most prohibit it from meeting existing § 35.396(d)(1) and who have the clinically effective emissions of the requirements or if additional relevant work experience described in radioactive drug requiring a WD. The requirements are needed for safety. § 35.396(d)(2) to be eligible for AU commenter's proposal would result in When a radionuclide is licensed under status to administer parenteral implementation difficulties without a § 35.1000, specific T&E requirements are radioactive drugs. The commenter commensurate increase in safety. included in the licensing guidance for stated that this is an appropriate level of Further, the NRC deleted that particular radioactive drug. T&E for administration by hematologists

§ 35.390(b)(1)(ii)(G)(4) and included Comment: Several commenters stated and oncologists of a specific radioactive radioactive drugs primarily used for it would be difficult for AUs to get the drug, ZevalinR, used primarily for its their alpha characteristics in additional supervised work experience beta emissions.

§ 35.390(b)(1)(ii)(G)(3). associated with three cases using Response: No change was made to the Comment: One commenter radioactive drugs containing rule text based on this comment. The recommended eliminating the separate radionuclides used primarily for their NRC did not intend to propose any dosage category used primarily for alpha alpha emissions. One commenter change to this T&E requirement in the emitters. The commenter suggested that pointed out that there is only one FDA- proposed rule, and, therefore has not if a new radioactive drug became approved alpha-emitting radioactive developed the regulatory basis to make available that was more hazardous than drug and that it is used in a limited any change to this requirement in this radium-223 dichloride and warranted population. Several other commenters final rule. During the preparation of the additional radiation safety regulatory stated that patients who do not live near proposed rule, an administrative error requirements, then NRC could license it teaching hospitals and urban centers resulted in the addition of the word under the provisions of § 35.1000. may have limited access to radioactive "or" between the rule text in § 35.396(c)

Response: The rule text was modified drugs in the two parenteral categories. and (d). The NRC did not intend to put based on a recommendation from the Certain practitioners, particularly those an "or" between paragraphs (c) and (d)

ACMUI. The NRC deleted in areas far removed from teaching and is correcting the error by removing

§ 35.390(b)(1)(ii)(G)(4) and included hospitals and urban centers, may find it the word "or" in the final rule text radioactive drugs primarily used for too burdensome to participate in three between paragraphs (c) and (d). This their alpha characteristics in proctored cases in each of these very administrative error could have been

§ 35.390(b)(1)(ii)(G)(3). The NRC specific categories. interpreted to require that a physician anticipates that all radioactive drugs Several commenters stated that the complete only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of T&E for that will be used for their alpha-emitting proposed changes in § 35.390(b)(1)(ii)(G) parenteral administration of unsealed characteristics can be regulated under would discourage clinicians from byproduct material requiring a WD.

§ 35.390(b)(1)(ii)(G)(3). However, the seeking authorization to administer The NRC notes that to obtain NRC may regulate radionuclides under these radioactive drugs and would make authorization to use parenteral

§ 35.1000 as appropriate. an already burdensome regulatory radioactive drugs requiring a WD, the Comment: One commenter noted that scheme more onerous. The commenters physician must either (1) meet the T&E NRC regulations are designed to provide suggested that the NRC revise the requirement or be certified by a medical flexibility for emerging technologies and proposed work experience requirement specialty board recognized under could be adjusted to recognize that in categories in § 35.390(b)(1)(ii)(G)(3) or § 35.390 and meet the clinical case work alpha and beta emitters are a new class 35.390(b)(1)(ii)(G)(4) to have three criteria in § 35.390, or (2) meet the T&E of therapeutic radiopharmaceutical proctored cases in either category be requirement or be certified by a medical products. The commenter referenced satisfactory to meet the requirements for specialty board recognized under Radium-223 dichloride and a potential both categories. §§ 35.490 or 35.690 and satisfy the new actinium alpha emitter. The Several commenters acknowledged additional 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of T&E requirement commenter suggested that the NRC that the clarifications of the categories of specified in § 35.396(d).

should create a new T&E requirement parenteral administrations were useful Comment: Two commenters stated specific to therapeutic and logical. However, they agreed with that NRC's regulations create a shortage radiopharmaceuticals based upon their another commenter that there was an of AUs able to administer certain unique characteristics, typical setting unintended consequence of increasing therapeutic radioactive drugs.

for administration, and safety record the work experience burden for those Specifically, under current regulations, (such as was done for sodium iodide I- seeking administration of a radioactive drug requiring a WD that 131 at §§ 35.392 and 35.394). The NRC radiopharmaceuticals with alpha and is administered parenterally and used could give license applicants an option beta emitters. primarily for its beta radiation to petition NRC for review under Response: The rule text was modified characteristics can only be administered

§ 35.1000 for a drug that technically fits based on a recommendation from the by an AU who has met the T&E within the four categories listed in ACMUI. The NRC deleted requirement set forth in § 35.396. This

§ 35.390(b)(1)(ii)(G), but is deserving of § 35.390(b)(1)(ii)(G)(4) and included requirement involves either board

33068 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations certification or 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E (APA) requirement to provide notice result of an administrative error. The specifically in radionuclide handling. and an opportunity for comment. The NRC did not mention or discuss any One of the commenters stated that commenter stated that the NRC changes to these T&E requirements in hematologists and oncologists who provided adequate notice of an any other part of the proposed rule typically prescribe therapeutic amendment to this T&E requirement Federal Register notice. The NRC did radiopharmaceuticals outside of the and that the NRC received substantial not intend to propose any changes to hospital setting often do not have the public input on these T&E requirements. this T&E requirement, and therefore the T&E required to meet the AU Alternatively, according to the NRC has not developed a regulatory requirements and do not work at commenter, the NRC could invoke the basis to make any such change in this facilities that have such AUs. They have "good cause" exemption from the APA final rule. The NRC agrees with the extensive T&E, and are frequently board notice and comment requirements comment that, before proposing any certified, but in different specialized because the 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> T&E requirement changes to this T&E requirement, the fields. for these parenteral radioactive drugs NRC and ACMUI should analyze Response: No change was made to the has caused a decrease in the number of whether a change in the requirement is rule text based on these comments. The AUs for these drugs and a warranted and advisable from a NRC believes that the commenters are corresponding decrease in patient radiation health and safety perspective.

referring to the requirement in § 35.390, access to these drugs. The commenter In response to commenter's concerns because the 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> criterion is in also proposed that the NRC could, about this T&E requirement, the NRC

§ 35.390 and not in § 35.396. instead of amending T&E requirements and ACMUI began considering whether Without compromising radiological at § 35.396(d), include in this final rule a change in this requirement is health and safety, the NRC strives to a new section that would require 80 warranted. Spectrum Pharmaceuticals, ensure that its regulations do not restrict hours of T&E specifically for the Inc. requested a meeting with NRC staff patient access to diagnostic and parenteral administration of patient-treatment options. The intent of NRC's to explain its comments concerning this ready doses of alpha- and beta-emitting T&E requirement. The NRC staff agreed T&E requirements is to ensure that AUs radioactive drugs. One other commenter are adequately trained so that their and held a public meeting on February also supported reducing this T&E handling and administration of 12, 2015, at which Spectrum requirement to 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> as part of this Pharmaceuticals, Inc. and Florida radioactive drugs is radiologically safe final rule and provided a proposed for patients, workers, and the public. Cancer Specialists & Research Institute training program.

The current T&E requirements are Several other commenters also presented their comments and concerns protective of radiological health and that this T&E requirement causes a expressed support for reducing this T&E safety. As explained in greater detail in shortage of AUs, and, therefore a barrier requirement in this final rule. The a response to another comment on commenters asserted that the 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> to patient access. In response to these parenteral administrations, throughout T&E requirement has caused a lack of comments and concerns, throughout 2015 and early 2016 the ACMUI AUs available to administer these 2015 and early 2016 the ACMUI assessed the concerns raised in this radioactive drugs; administration of assessed whether this T&E requirement comment. Additionally, the ACMUI these drugs presents no greater radiation places a hardship on the patient established a standing subcommittee health and safety risk than oral community. In a public teleconference that will periodically assess the T&E administration of 1-131; and 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of held on June 16, 2015, the Florida requirements across all modalities and T&E is sufficiently protective of Cancer Specialists & Research Institute make recommendations for changes as radiological health and safety. presented to the ACMUI its concerns warranted. The NRC will also continue Several commenters opposed that this T&E requirement caused a lack to consider whether changes to these changing this T&E requirement in the of AUs and thus a barrier to patient T&E requirements are warranted. final rule. One commenter stated that access to these radioactive drugs. After With respect to the comment that the NRC and ACMUI would need to this teleconference, the ACMUI formed hematologists and oncologists "typically analyze key issues before proposing any a subcommittee to assess whether the prescribe therapeutic changes to this T&E requirement, 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> T&E requirement for radiopharmaceuticals ... ,." the NRC including whether a reduction in the parenteral administration of this class of regulations require that such requirement is advisable from a radiopharmaceuticals places a hardship radiopharmaceuticals be administered radiation health and safety perspective. on the patient community by creating a in accordance with a WD. A WD is an These commenters stated that an AU shortage of AUs. In its subcommittee AU's-not a hematologist's or would need to receive adequate training report dated September 21, 2015, which oncologist's-written order for the on a broad array of radiation health and the ACMUI unanimously approved at its administration of byproduct material or safety topics and that an 80-hour course Fall 2015 meeting, the ACMUI radiation from byproduct material to a would not sufficiently cover these concluded that it was unable to specific patient, as specified in § 35.40. topics. These commenters also substantiate this claim. The ACMUI Comment: Several commenters described the range of activities, found that the infrequent and steadily provided comments after the public considerations, and procedures decreasing use of specific beta-emitting comment period on whether the NRC necessary to ensure the safe handling radioactive drugs-specifically should amend the T&E requirement for and administration of these radioactive radioactive drugs that are used to treat the parenteral administration of drugs. lymphoma, such as Spectrum radioactive drugs as part of this final Response: No change was made to the Pharmaceuticals, Inc.'s drug Zevalin-rule. rule text based on these comments. As is due to many factors. The ACMUI One commenter stated that amending stated in response to another comment concluded that it could not determine

§ 35.396 to reduce the T&E requirement on § 35.396, the proposed rule text that whether there is a shortage of AUs and, to 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in this final rule would be could have been interpreted to require if so, whether the NRC's T&E a logical outgrowth of the proposed rule only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of T&E for a physician to requirement caused the shortage. The and thus would satisfy the obtain AU status to administer subcommittee was then charged with Administrative Procedure Act of 1946 parenteral radioactive drugs was the continuing to assess this issue and

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33069 establishing a recommendation for the Although the statement of Response: The rule text was modified total number of hours of T&E for AUs considerations for the proposed rule based on this comment. The rule text of this class of radioactive drugs that stated "manual brachytherapy sources was changed to include the term appropriately balances safety with can be used for medical uses not listed ophthalmic physicist in § 35.433(a)(2).

reasonable patient access to these in the SSDR", the rule text is more The NRC agrees that, for clarity, the radioactive drugs. limiting and states ". . . manual term ophthalmic physicist must be In its subcommittee report dated brachytherapy sources may be used for included in this section. By including March 10, 2016, which the ACMUI manual brachytherapy uses that are not the term "ophthalmic physicist," it is unanimously approved at its meeting on explicitly listed in the SSDR." The clear that the requirements in this same date, the ACMUI reiterated its commenters' example of using a manual § 35.433(a)(2) apply to an individual conclusion that it could not substantiate brachytherapy source for a temporary who is named as an ophthalmic the claim that the T&E requirement diagnostic localization procedure is not physicist and meets the definition of an caused a shortage of AUs and thus a permitted under the provisions of "ophthalmic physicist" in § 35.2.

hardship on the patient community. For § 35.400 because it is a diagnostic use Comment: Several commenters this reason, and because the ACMUI and not a manual brachytherapy use. questioned the need for § 35.433(b)(2) identified several issues raised by the However, such use may be authorized and recommended its removal. They reduction in T&E requirements that under the provisions of § 35.1000. thought that the actions regarding the some commenters recommended, the Comment: One commenter agreed WD were already required by the ACMUI recommended against reducing with the NRC that the limitations and licensee in § 35.41 and that no other the T&E. However, the ACMUI consideration of use listed in the SSDR modality requires a procedure regarding recognized the need for a thorough be followed. The commenter believed the frequency of involvement by the review of T&E requirements across all that the "SSDR reviewer should identify medical physicist. The commenters also modalities because of the introduction and list requirement [sic] and discuss asked why the other individual of new radioactive drugs since the issues on how to license these products [identified in § 35.433(b)(2)] could not requirements were established 15 years for safe use." The commenter stated work under the supervision of the AMP ago and because the educational that, by doing this, the SSDR reviewer or request an exemption from the paradigm has shifted from prescriptive helps ensure uniformity in the licensing requirement.

curricula to competency-based requirements, and saves resources for Response: No change was made to the education. The ACMUI established a industry and regulatory agencies in not rule text based on these comments.

standing subcommittee to assess T&E having to independently obtain this Although the regulations do not prohibit requirements for all modalities and information. a licensee that has an AMP from also provide recommendations to the NRC Response: No change was made to the having an ophthalmic physicist, the staff. As stated in response to other rule text based on this comment. The primary purpose of the ophthalmic comments, the NRC will continue to NRC revised § 35.400 because existing physicist is to provide physics support consider concerns regarding T&E SSDR sheets do not, nor are they to the ophthalmic AU when the licensee requirements to ensure that these expected to, describe all manual does not have access to an AMP. The requirements are sufficient to ensure brachytherapy medical procedures for ophthalmic physicist is an individual radiological health and safety for which the manual brachytherapy seeds recognized by the NRC, Agreement patients, workers, and the public can be used. During the evaluation, the States, medical licensees of broad scope, without unnecessarily creating barriers reviewer focuses on radiation safety master material licensees or master to patient access to diagnostic and conditions and limitations of use. material medical permittees of broad treatment options. scope by T&E, to perform certain Section 35.433 Strontium-90 Sources functions listed under § 35.433. This Section 35.400 Use of Sources for for Ophthalmic Treatments individual is authorized to work Manual Brachytherapy Comment: One commenter stated that independently and is not required to Comment: Several commenters did the proposed regulations concerning work under the supervision of an AMP.

not agree with the proposal in § 35.400 ophthalmic physicists in § 35.433, The purpose of § 35.433(b) is to that manual brachytherapy sources may which separate physicists who assist in describe the minimum performance-be used for medical purposes not listed ophthalmic procedures from AMPs who based tasks expected of either the AMP in the SSDR. The commenters believed are involved in the uses allowed under or the ophthalmic physicist in assisting that this change would permit sources §§ 35.600 and 35.1000, were an the licensee and AU with the to be used by medical personnel who improvement. ophthalmic treatment program. The have not received any radiation safety Response: The comment supports requirement that only an AMP shall training. As an example, they cited the language in the rule; therefore, no calculate the activity of each Sr-90 case where brachytherapy sources are response is required. source is an existing requirement in the used in temporary diagnostic Comment: One commenter regulations under § 35.433(a) and is not localization procedures under the recommended a revision of a new requirement. The requirement in provisions of § 35.1000. In this case, the § 35.433(a)(2) to specifically include the § 35.433(b)(2) codifies that the AMP, or guidance requires licensees to submit term "ophthalmic physicist." The ophthalmic physicist, is to assist the their training program for nonmedical commenter pointed out that although licensee and AU in assuring that the staff that are not covered under their the NRC defined the "ophthalmic requirements in § 35.41 are met.

current medical license. The physicist" to be "an individual who Ophthalmologists using these devices commenters believed that by requiring meets the requirements of § 35.433(a)(2) are frequently in small programs with these uses under the provisions of .... " the NRC did not use the term limited access to services of an AMP.

§ 35.1000, the regulatory agencies can "ophthalmic physicist" in § 35.433. The The proposed rule change was made in ensure that radiation safety for all commenter recommends changing the part to ensure that the ophthalmic workers is verified before use. text in § 35.433(a)(2) to read: An physicist (or AMP) performs a minimum Response: No change was made to the individual named as an ophthalmic number of tasks at the ophthalmology rule text based on these comments. physicist who: (i) Holds a masters..." office.

33070 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations The NRC did not specify the Comment: An Agreement State Section 35.490 Training for Use of frequency of involvement of the AMP or pointed out that its licensure Manual Brachytherapy Source ophthalmic physicist because the requirements for "Medical Physicist" Comment: One commenter stated that licensee should determine the best are currently consistent with NRC's the requirements for supervised work frequency for its program. The NRC requirement for an AMP in 10 CFR part experience under § 35.490(b)(1)(ii) were requires AMPs to perform certain tasks 35. The T&E of the "ophthalmic written vaguely, and that it can and has at specified frequencies for certain physicist" does not meet its licensure been interpreted as 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work medical use programs. Specifically, requirements and it is unclear whether related to radiation therapy, not AMPs are required to participate the individual would meet the specifically to brachytherapy. The initially, and at least annually, in drills accreditation standards set by the commenter believed that this of emergency procedures under American College of Radiology (ACR) or interpretation is reasonable, but that it

§ 35.610. They also must be physically would be helpful to have some specific the American College of Radiation present during initiation of patient brachytherapy related guidance on, e.g.,

Oncology (ACRO) in radiation oncology, treatment, continuation of the treatment, the number of cases the proposed AU or which the State requires for manual or the entire treatment, depending on AMP should observe and/or perform brachytherapy. All state licensees that the unit being used under § 35.615. In under supervision, or the length of time addition, AMPs must perform the full are authorized for possession and use of a Sr-90 eye applicator have the services they should perform these procedures calibration measurements and decay under supervision.

corrections before first medical use, of an AMP for other brachytherapy and external beam therapy uses. The Response: No change was made to the before medical use under certain rule text based on this comment. It conditions, and at intervals not to commenter also questioned whether it appears that the commenter's statement exceed one year under §§ 35.632, would relieve a shortage of physicists in is limited to the rule text in 35.633, and 35.635. rural areas, because the proposed rule

§ 35.490(b)(1)(ii). However, Comment: An Agreement State does not require an AMP or ophthalmic § 35.490(b)(1)(ii) should be taken in the pointed out that in its State statutes, an physicist to be physically present at the context of all of the training individual who practices medical licensee's authorized location of use, requirements in § 35.490(b)(1), which physics is required to be licensed by the with the possible exception of the initial states, "Has completed a structured State. Because § 35.422 is designated as source calibration that is performed on educational program in basic "Health and Safety" (H&S), the site or to be on site to perform the decay radionuclide handling techniques Agreement State must promulgate its correction and treatment times. The applicable to the use of manual rule to require medical physicists to commenter concluded that the addition brachytherapy sources that includes [(i) comply with its statute. The commenter of this proposed category of physicist and (ii)]." Further, the tasks that are to recommended that the rule text be did not appear to be applicable in its be performed under § 35.490(b)(1)(ii) changed to "allow the individual to state and therefore should not be include § 35.490(b)(1)(ii)(C): Preparing, work under the supervision of an AMP required for state adoption. The implanting, and removing as authorized by state laws." commenter proposed that the NRC brachytherapy sources. The NRC does Response: No change was made to the assign Compatibility Category "B" to not require a minimum number of cases rule text based on this comment. The those states that will and category "D" because the requirement for a total of NRC believes that the commenter is to those that will not use the 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work referring to § 35.433, not § 35.422 (as designation of ophthalmic physicist. experience, including the tasks required there is no § 35.422 in the regulation). under § 35.490(b)(1)(ii)(C), is sufficient The revision of the rule does not Response: No change was made to the to ensure the safe use of manual prohibit a State from requiring the rule text or to the compatibility category brachytherapy sources.

"ophthalmic physicist" to be licensed designation for the T&E requirements by the State as long as the licensure for an ophthalmic physicist under Section 35.500 Use of Sealed Sources requirements include components § 35.433(a) based on this comment. All and Medical Devices for Diagnosis essentially identical to NRC T&E NRC T&E requirements in 10 CFR part Comment: Several commenters noted requirements. The purpose of adding 35 are designated as Compatibility that NRC's revision to § 35.500(a) and the ophthalmic physicist was to identify Category B, which means they have (b) states that "[a] licensee must only an individual who could assist the direct and significant transboundary use sealed sources or diagnostic devices licensee when the licensee does not effects. The licensee is required to have that are approved in the Sealed Source have access to an AMP. In this situation, procedures that specify the frequency at and Device Registry..." and also the ophthalmic physicist cannot work which the AMP or ophthalmic physicist states "may be used for...." One under the supervision of an AMP would observe treatments, review the commenter stated that these revisions because the licensee does not have an treatment methodology, calculate contradicted each other, because the AMP to perform the activities listed in treatment time for the prescribed dose, revision states that the licensee "must"

§ 35.433(b). Further, the ophthalmic and review records to verify that the for some uses but then uses "may" for physicist is authorized independently treatment was in accordance with the other uses. Several commenters thought and is not required to work under the WD. The individual must be physically this provision put a burden on the SSD supervision of an AMP. The designation present at the licensee's authorized reviewing agency to ensure that proper "H&S" in the summary refers to location of use on a set frequency to conditions are included in the SSD program elements that are not required allowing for other uses. They disagreed complete these tasks. The NRC believes for compatibility, but are identified as with the revision and recommended that having an individual who is not an having a particular health and safety that any other uses of these sealed AMP, but is qualified to perform the significance. The State should adopt the sources should be approved by the essential objectives of such program tasks specified and to perform some of licensing regulatory agency.

elements in order to maintain an them on site, will benefit rural Response: The rule text was modified adequate program. licensees. based on these comments. The rule text

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33071 in § 35.500(a) was changed in order to recommend either changing the name of manufacturer is the most knowledgeable make it clear that it is the sealed the section or adding a new section for entity when it comes to its new devices sources, as opposed to the diagnostic the units. or upgrades to devices that affect their medical uses, that must be approved in Response: No change was made to the safety and operation. The NRC's intent the Sealed Source and Device Registry rule text based on these comments. The is that before the device can be used on (SSDR). The rule text in § 35.500(b) was current title of the section already the first patient, each staff member not changed because the NRC believes includes the sealed sources and the involved in the operation of the device the language in this section is clear. The devices in which the sources are used. for that first patient's treatment must revision in § 35.500(a) now states, "A The requirements in paragraphs (a) and receive training on the operational and licensee must use only sealed sources (b) parallel this structure. safety features and procedures from the that are not in medical devices for Comment: Several commenters vendor or individuals certified by the diagnostic medical uses if the sealed recommended that § 35.600(b) be vendor to provide the training. For sources are approved in the Sealed revised to read: "A licensee must use subsequent patient treatments, the Source and Device Registry for photon emitting remote afterloader requirements in § 35.610(d)(2) apply.

diagnostic medicine. The sealed sources units, teletherapy units, or gamma Comment: One commenter agreed may be used for diagnostic medical uses stereotactic units: that, with respect to the revisions to that are not explicitly listed in the i. That are approved in the Sealed § 35.610(d)(1), after modifications to the Sealed Source and Device Registry but Source and Device Registry; or unit, staff authorized to use the unit must be used in accordance with the ii. In research .. "

Response: No change was made to the needs to be trained on the upgrade and radiation safety conditions and how the upgrade affects the operation of limitations described in the Sealed rule text based on these comments. The purpose of the revisions to § 35.600(b) is the unit. The commenter wanted Source and Device Registry." The clarification on whether ". . . upgrade revision in § 35.500(b) continues to to clarify that the photon-emitting that affects the operation and safety of state: "A licensee must only use remote afterloader units, teletherapy units, or gamma stereotactic units must the unit" is meant to cover changes to diagnostic devices containing sealed the actual device itself or changes to the sources for diagnostic medical uses if be used in accordance with the device and any changes to the treatment both the sealed sources and diagnostic limitations and considerations of use listed in the SSDR and to allow the planning system (software/hardware).

devices are approved in the Sealed Response: No change was made to the Source and Device Registry for licensee to use the units for medical uses not explicitly listed in the SSDR. rule text based on this comment. The diagnostic medical uses. The diagnostic rule covers both software and hardware medical devices may be used for The commenters' proposed change would not address these issues. changes that affect the operation and diagnostic medical uses that are not safety of the remote afterloader unit, explicitly listed in the Sealed Source Section 35.610 Safety Procedures and teletherapy unit, or gamma stereotactic and Device Registry but must be used in Instructions for Remote Afterloader radiosurgery unit.

accordance with the radiation safety Units, Teletherapy Units, and Gamma Comment: One commenter wanted conditions and limitations described in Stereotactic Radiosurgery Units clarification on whether the requirement the Sealed Source and Device Registry." "or by an individual certified by the To clarify, the first part of the Comment: One commenter questioned why the revisions to § 35.610(d)(1) device manufacturer..." included a requirement in each paragraph is to require training on a new unit to be person at the organization (one of the restrict the licensee to only use sealed sources and devices for diagnostic provided only by the vendor or authorized operators) who received the purposes if they are approved for individuals certified by the vendor. The device upgrade training from the diagnostic purposes in the SSDR. The commenter does not believe there is manufacturer and would then be able to purpose of the second part of the clear evidence that vendor training is train all other authorized operators at requirement in each paragraph is to superior to a course the licensee might the organization.

allow the licensee the flexibility to use develop and that the quality of vendor Response: The rule text was modified diagnostic sealed sources and devices training is quite variable. The based on this comment. The rule text in for medical uses other than those that commenter was also concerned that if a § 35.610(d)(1) was revised to clarify that are explicitly included in the SSDR. As staff member missed the vendor's the vendor training can only be long as the limitations and conditions training, the licensee would be required provided by either the device included in the SSDR address those to make special arrangements, probably manufacturer or by an individual generally needed for diagnostic uses, at considerable cost, to have that person certified by the device manufacturer to there is no additional burden on the trained as required. The commenter provide the operational and safety SSD reviewer to revise the SSD for a stated that in most cases the licensee training. Therefore, an authorized new diagnostic use not explicitly stated. will choose to have all staff trained by operator at the licensee's facility that is If the licensee intends to use a the vendor when a new device is certified by the device manufacturer to diagnostic sealed source or device for a installed. The commenter believed that provide the operational and safety non-diagnostic use, then the licensing licensees should be allowed to provide training may provide initial instruction regulatory agency will need to training to their personnel in the to other authorized operators at the determine how to license such use. manner they deem the best as is the case facility.

today and would be the case at existing Section 35.600 Use of a Sealed Source Section 35.655 Full-Inspection installations under the proposed rule.

in a Remote Afterloader Unit, Servicing for Teletherapy and Gamma Response: The rule text was modified Teletherapy Unit, or Gamma Stereotactic Radiosurgery Units based on this comment. The rule text Stereotactic Radiosurgery Unit was changed to clarify that the Comment: One commenter stated that Comment: Several commenters stated individuals certified by the device a full inspection is only possible when that the revision splits the section into manufacturer to provide vendor training the sources in a gamma stereotactic two paragraphs where (a) is used for must be specifically certified to provide radiosurgery unit are replaced. The sources and (b) is used for units. They this training. The medical device commenter recommended that the full

33072 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations inspection frequency be revised to occur individual should be allowed to acquire Issue: The Medical Event Reporting upon source exchange. a portion of the required 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of Criterion Are Based on the Term Response: No change was made to the work experience at a facility that does "Potential Harm" rule text based on this comment. The not use byproduct material in § 35.600. Comment: Several commenters stated NRC agrees that the full inspection is Response: No change was made to the that they do not agree with the use of only possible when the sources in a rule text based on this comment. The the term "potential harm" in the gamma stereotactic radiosurgery unit are amendment the commenter described discussion of MEs in the Federal replaced. Further, the NRC believes that was made to ensure that the supervised Register notice for the proposed rule.

the source replacement interval for a work experience was obtained at a The commenters believe that "potential gamma stereotactic radiosurgery unit medical facility (including a stand-alone harm" is a medical decision and that can be extended to 7 years because of single discipline clinic) where the this approach is a significant departure the 6-month routine preventive facility is authorized for uses under from the current definition of an ME.

maintenance performed on these units. § 35.600. Section 35.690 also includes a The commenters believe that this requirement that the individual Section 35.690 Training for Use of approach will eliminate the opportunity complete a 3-year accredited residency Remote Afterloader Units, Teletherapy for licensees to identify precursor events program in radiation therapy. This Units, and Gamma Stereotactic and make process improvements, and residency program is not restricted to a Radiosurgery Units that it could have the unintended facility that is authorized for § 35.600 Comment: One commenter stated that uses. The NRC recognizes that the consequence of providing additional it was unclear how an individual who "concepts learned" that the commenter support for malpractice suits. In is board certified but beyond 7 years of referred to may be obtained from such articulating their objection to NRC's the required training may seek AU or a facility but that the individual still position, some commenters stated that AMP status. The commenter believed needs 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work "[a]s regulators, we are not tasked for that, for safety, there should be some experience with the § 35.600 devices. determining what the 'potential harm' minimum number of cases the Comment: One commenter expressed is, our mission is to ensure licensees individual must observe prior to concern regarding whether a residency abide by the required regulations."

obtaining AU or AMP status especially program approved by the Royal College Response: The NRC believes that the in light of the complexity of interstitial of Physicians and Surgeons of Canada rule will not discourage licensees from procedures such as LDR or HDR can be used to meet the requirements in identifying precursor events or making prostate. § 35.690(b)(2) because of the specific process improvements. The rule Response: No change was made to the mention of a medical facility authorized continues to reflect the NRC's position rule text based on this comment. The to use byproduct material in § 35.600. that an ME may be indicative of NRC reviews, on a case by-case basis, Currently, the NRC's, "Procedures for potential problems in a medical each applicant who received board Recognition of Foreign Trained facility's use of radioactive materials certification more than 7 years ago and Physicians and Physicists Applying for and does not necessarily result in harm requests to be authorized as an AU or Authorized User (AU) and Authorized to the patient. This position is based on AMP. The licensee must demonstrate Medical Physicist (AMP) Status," states the NRC staff recommendations that the individual has had related that a physician coming out of a submitted to the Commission in SECY-continuing education and experience residency approved by the Royal 05-0234, "Adequacy of Medical Event since the required training was College of Physicians and Surgeons of Definitions in § 35.3045, and completed. Because of the rigorous T&E Canada would need to work under a Communicating Associated Risks to the requirements already in place, the NRC physician who also practices in the Public," dated December 27, 2005. The has not set a minimum number of cases United States. While such physicians NRC staff recommendations were a physician or a medical physicist must likely exist, adding the additional approved by the Commission in SRM to observe prior to obtaining AU or AMP requirement that the facility is SECY-05-0234, dated February 15, status. authorized to use byproduct material in 2006. The ME criteria for permanent Comment: One commenter stated that § 35.600 appears to add an additional implant brachytherapy are now replacing "institution" in hurdle to allowing hours from these consistent with the criteria for other

§ 35.690(b)(1)(ii) with "facility that is residencies. therapeutic modalities by reflecting authorized to use byproduct material in Response: No change was made to the circumstances in which there may be 35.600" may cause difficulties without rule text based on this comment. The harm or potential harm to the patient.

any apparent benefit. Under current commenter is correct that a physician regulations, a residency program at an Issue: The Medical Event Reporting completing a residency program Criterion Related to the Absorbed Dose institution that has only linear approved by the Royal College of accelerators can provide some of the to Normal Tissues Located Within the Physicians and Surgeons of Canada may work experience pertinent to the Treatment Site have to complete his or her 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> requirements at its institution so long as of supervised work experience at Comment: One commenter had it has the appropriate AUs on staff another facility that is authorized for questions and expressed concerns about (which is common with physician uses under § 35.600. the ME reporting criterion in § 35.3045 faculty practicing at affiliated outpatient related to "intra-target" normal tissue.

facilities). While residents need some Section 35.3045 Report and The commenter stated that for prostate direct work experience with, for Notification of a Medical Event implants the urethra is the only such example, treatment planning for HDR The NRC received many comments on structure to consider, and the volume is after loaders, there are concepts learned various issues related to the permanent much less than 5 cubic centimeters. The in a linear accelerator treatment brachytherapy event reporting criteria commenter wanted to know whether, if planning that apply. This is especially under this section. For better the dose threshold for reporting an ME true of external beam therapy from understanding of the concerned raised, was exceeded for the urethra, given that radioactive sources. Therefore, if a the comments are grouped according to the volume is less than 5 cubic preceptor judges it to be appropriate, an the distinct issues commenters raised. centimeters, if that instance would

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33073 require reporting. The commenter also a licensee is appropriately classifying Response: The rule text was modified expressed concern that treatment and reporting MEs. based on this comment. The rule text in planning systems could not distinguish Response: The rule text was modified § 35.3045(a)(2) was modified to remove between a 5 cubic centimeters volume based on this comment. The rule text in § 35.3045(a)(2)(iv), which would have and a summation of five 1 cubic § 35.3045(a)(2) was modified to remove required the assessment of the absorbed centimeters volumes receiving 150 § 35.3045(a)(2)(iv), which would have dose to normal tissue within the percent of the prescribed dose. required the assessment of the absorbed treatment site. The NRC agrees with the Response: The rule text was modified dose to normal tissue within the commenter's suggestion and in response based on this comment. The rule text in treatment site. The NRC understands to this concern and those raised by other

§ 35.3045(a)(2) was modified to remove that it may be difficult for licensees and commenters, the NRC removed the use

§ 35.3045(a)(2)(iv), which would have regulators to determine if an ME of absorbed dose-based criteria for required the assessment of the absorbed occurred under this criterion. In reporting MEs in § 35.3045(a)(2)(iv).

dose to normal tissue within the response to this concern and those Comment: One commenter expressed treatment site. The NRC understands raised by other commenters, the NRC concern about the ME reporting that the volume of the urethra within removed the absorbed dose-based ME criterion in § 35.3045(a)(2)(iv) related to the treatment site is typically less than reporting criterion in § 35.3045(a)(2)(iv). the absorbed dose to normal tissue 5 cubic centimeters. In addition, the Comment: One commenter expressed located within the treatment site. The NRC acknowledges the commenter's concerns about the ME reporting commenter stated that "precise control concern that treatment planning systems criterion in § 35.3045 related to the of source location inside the treatment may not distinguish contiguous volumes normal tissue located within the site over several half-lives is impossible from non-contiguous, summated treatment site. The commenter stated (and not necessary), so absorbed dose to volumes. In response to this concern that the normal tissue within the intra-target structures is impossible to and those raised by other commenters, treatment site for prostate implants is control." The commenter believes this is the NRC removed the absorbed dose- the urethra and it is necessary to place a medical decision, not a suitable ME based ME reporting criterion in a catheter in the urethra to assess dose criterion. The commenter stated

§ 35.3045(a)(2)(iv). to this tissue. The commenter noted that "[m]edicine has to operate in a risk-Comment: One commenter expressed licensees may not routinely catheterize benefit balance when it comes to normal concerns about the absorbed dose-based the patient during post-implantation tissues, so the NRC has no role here."

criterion for normal tissue within the imaging; therefore, they do not have the Response: The rule text was modified treatment site and stated that it is imaging information necessary to assess based on this comment. The rule text in common for 50 percent or more of the urethral dose. The commenter further § 35.3045(a)(2) was modified to remove treatment site to receive a dose that stated that pre-implantation images § 35.3045(a)(2)(iv), which would have exceeds the prescribed dose by greater performed on catheterized patients required the assessment of the absorbed than 50 percent. The commenter was show that the urethral volume is dose to normal tissue within the concerned that quality implants may be typically 1 cubic centimeter or less. The treatment site. The NRC acknowledges categorized as MEs using this criterion. commenter concluded that an ME the commenter's concern that absorbed The commenter also stated that its would never be found for normal dose to intra-target structures is vendor's software does not provide a urethral tissue for a prostate implant impossible to control and is a medical method to evaluate dose to contiguous because there is not 5 cubic centimeters decision. In response to this concern volumes of tissue within the treatment of contiguous urethral tissue within the and those raised by other commenters, site. treatment site. the NRC removed the dose-based ME Response: The rule text was modified Response: The rule text was modified reporting criterion in § 35.3045(a)(2)(iv).

based on this comment. The rule text in based on this comment. The rule text in Comment: One commenter stated that

§ 35.3045(a)(2) was modified to remove § 35.3045(a)(2) was modified to remove "[i]dentification of normal tissue in the

§ 35.3045(a)(2)(iv), which would have § 35.3045(a)(2)(iv), which would have treatment volume (urethra) [during a required the assessment of the absorbed required the assessment of the absorbed prostate implant procedure] is difficult dose to normal tissue within the dose to the maximally exposed 5 if not impossible with a CT scan." The treatment site. The NRC agrees that contiguous cubic centimeters of normal commenter also stated that the radiation quality implants may be categorized as tissue within the treatment site. The dose is variable across the treatment site MEs if 50 percent or more of the NRC understands that licensees may not and therefore the "determination" of the treatment site intentionally receives a routinely acquire the imaging dose to the normal tissue within the dose that exceeds the prescribed dose by information necessary to assess post- treatment site is "ambiguous." The greater than 50 percent. The NRC implantation urethral dose. The NRC commenter further stated that "[t]he understands that some treatment also understands that the urethral only way to clearly define the urethra planning software may be unable to volume within the treatment site is during the post Dosimetry CT scan distinguish contiguous volumes of typically considerably less than 5 cubic would be to catheterize the patient, tissue. In response to this concern and centimeters, and as a result it is unlikely which would cause significant pain to those raised by other commenters, the that an ME would occur using the the patient, and therefore is not NRC removed the absorbed dose-based proposed criterion. performed."

ME reporting criterion in Comment: One commenter stated that Response: The rule text was modified

§ 35.3045(a)(2)(iv). using absorbed dose-based criteria may based on this comment. The rule text in Comment: One commenter expressed limit the licensee's ability to determine § 35.3045(a)(2) was modified to remove concerns about the ME reporting if an ME has occurred when evaluating § 35.3045(a)(2)(iv), which would have criterion in § 35.3045(a)(2)(iv). The dose to normal structures located within required the assessment of the absorbed commenter stated that, using this the treatment site that are even more dose to normal tissue within the criterion, it would be difficult for difficult to contour than the prostate. treatment site. The NRC acknowledges licensees to determine if an ME had The commenter suggested removing the the commenter's concerns related to occurred and nearly impossible for use of absorbed dose-based criterion for difficulties associated with imaging the regulators to independently determine if normal tissue within the treatment site. urethra and estimating the dose to it. In

33074 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations response to these concerns and those Comment: Two commenters removed subparagraphs (iii) and (iv),

raised by other commenters, the NRC expressed concerns about the which would have required licensees to removed the absorbed dose-based ME requirement to evaluate and determine use absorbed dose criteria to report MEs reporting criterion in § 35.3045(a)(2)(iv). the absorbed dose to the maximally for permanent brachytherapy.

Comment: One commenter expressed exposed 5 contiguous cubic centimeters Comment: One commenter stated that difficulty in understanding how clinics of normal tissue "around" the treatment the volume for determining an absorbed that use a nomogram-based approach to site. The commenters further stated that dose to normal tissue for compliance "pre-planning," where there is no pre- these proposed ME reporting criteria are with the reporting requirements in implant dose distribution, would not consistent with current medical § 35.3045 is not clearly defined. The evaluate the ME definition for "intra- practice and may discourage licensees commenter noted that it appears target normal structures" in from performing permanent reasonable in theory to determine

§ 35.3045(a)(2)(iv). brachytherapy, which would deny absorbed dose to the maximally exposed Response: The rule text was modified patients access to this technology. 5 contiguous centimeters of normal based on this comment. The rule text in Response: The rule text was modified tissue. However, the commenter

§ 35.3045(a)(2) was modified to remove based on these comments. The rule text believes that it will be difficult to make

§ 35.3045(a)(2)(iv), which would have in § 35.3045(a)(2) was modified to this determination using current required the assessment of the absorbed remove § 35.3045(a)(2)(iii) and (iv), technology. The commenter stated that dose to normal tissue within the which would have required the "planning systems typically report dose treatment site. The NRC understands the assessment of the absorbed dose to the volume histograms to structures, but commenter's concern that clinics that maximally exposed 5 contiguous cubic they do not identify contiguous use a nomogram-based approach to centimeters of normal tissue outside and volumes."

"pre-planning," where there is no pre- within the treatment site. The NRC Response: The rule text was modified implant dose distribution, may have acknowledges the commenters' concern based on this comment. The rule text in difficulty in evaluating the dose to that the proposed rule text is not § 35.3045(a)(2) was modified to remove normal tissue within the treatment site consistent with current medical practice § 35.3045(a)(2)(iii) and (iv), which under the proposed ME definition. In and may discourage some licensees would have required the assessment of response to this concern and those from performing permanent the absorbed dose to normal tissue raised by other commenters, the NRC brachytherapy. In response to this outside and within the treatment site.

removed the absorbed dose-based ME concern and those raised by other The NRC acknowledges that while some reporting criterion in § 35.3045(a)(2)(iv). commenters, the NRC removed the treatment planning systems can identify absorbed dose-based ME reporting contiguous volumes, others cannot. In Issue: The Medical Event Reporting criterion in § 35.3045(a)(2)(iii) and (iv). response to this concern and those Criterion in § 35.3045 Related to the Comment: Two commenters raised by other commenters, the NRC Absorbed Dose to Normal Tissues expressed concerns about the use of removed the absorbed dose-based ME Located Outside the Treatment Site absorbed dose to 5 contiguous cubic reporting criterion in § 35.3045(a)(2)(iii)

Comment: One commenter expressed centimeters as a criterion for reporting and (iv).

concerns about the ME reporting MEs. The commenters noted that the Comment: One commenter stated that criterion in § 35.3045(a)(2)(iii) related to absorbed dose to 5 contiguous cubic the requirement in § 35.3045(a)(2)(iii) the absorbed dose to normal tissue centimeters was proposed as a guideline (absorbed dose to the maximally located outside the treatment site. The for treating cancer of the cervix in a exposed 5 contiguous centimeters of commenter stated that their treatment single journal article published 10 years normal tissue located outside of the planning software does not have an ago. The commenters also pointed out treatment site) will be difficult to automated method for determining the that these guidelines were proposed "for implement. The commenter stated that volume of normal tissue that exceeds research purposes," reflected the treatment planning systems report dose-the prescribed dose by 50 percent. They personal opinions of the authors, and volume histograms to structures but do stated that a manual method for making were not endorsed or adopted by any of not identify contiguous volumes. The such a determination would lead to the radiation oncology professional commenter also stated that the term different results depending on who organizations. The commenters "treatment site" is not well defined. The contours the normal tissue volume requested that the NRC provide further commenter used the prostate as an being assessed. The commenter also justification for establishing a 5 example and pointed out that some noted that the definition of "contiguous contiguous cubic centimeters regulatory licensees identify the prostate as the normal tissue" is not clear. standard. treatment site and develop the treatment Response: The rule text was modified Response: The rule text was modified plan with a particular margin of normal based on this comment. The rule text in based on these comments. The rule text tissue around it, while others include a

§ 35.3045(a)(2) was modified to remove in § 35.3045(a)(2) was modified to PTV (planning treatment volume)

§ 35.3045(a)(2)(iii), which would have remove § 35.3045(a)(2)(iii) and (iv), around the prostate and plan for that required the assessment of the absorbed which would have required the volume. The commenter explained that dose to normal tissue outside the assessment of the absorbed dose to the seeds may be placed in interstitial tissue treatment site. The NRC acknowledges maximally exposed 5 contiguous cubic outside the prostate to ensure adequate the commenter's concern that some centimeters of normal tissue outside and dose is delivered to the prostate. The treatment planning software may is not within the treatment site. The NRC commenter expressed concern that "[ilf capable of automatically determining included these requirements in the the normal tissue involved interstitial the volume of normal tissue that proposed rule based on a tissue, it would not cause a medically exceeds the prescribed dose by 50 recommendation from the ACMUI. significant event to the patient."

percent. In response to this concern and However, based on these and other Response: The rule text was modified those raised by other commenters, the comments, the NRC concluded that based on this comment. The rule text in NRC removed the absorbed dose-based absorbed dose to 5 contiguous cubic § 35.3045(a)(2) was modified to remove ME reporting criterion in centimeters is not a suitable criterion for § 35.3045(a)(2)(iii), which would have

§ 35.3045(a)(2)(iii). reporting MEs. Therefore, the NRC required the assessment of the absorbed

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33075 dose to normal tissue outside the in § 35.3045(a)(2) was modified to significance reported." Other treatment site. The NRC acknowledges remove § 35.3045(a)(2)(iii) and (iv), commenters stated that source(s) the commenter's concern that some which would have required the implanted directly into the wrong site or treatment planning software may be assessment of the absorbed dose to the body part, e.g., if the right breast was unable to automatically determine the maximally exposed 5 contiguous cubic implanted when the left breast was volume of normal tissue that exceeds centimeters of normal tissue outside and intended to be implanted, should the prescribed dose by 50 percent. The within the treatment site. The NRC constitute a reportable ME. One NRC also acknowledges that AUs agrees with removing the proposed commenter suggested that the NRC describe "treatment site" in different absorbed dose-based criteria for establish a reasonable de minimis ways. The NRC expects the AU to reporting MEs for normal tissue. threshold. Several commenters describe the treatment site (as defined in However, the NRC is not changing the suggested revising § 35.3045(a)(2)(v)(C)

§ 35.2) in the WD in any way he or she rule text to require licensees to establish to require that "sealed source(s) directly believes to be medically appropriate. In documented dose-based criteria such as delivered to a "non-contiguous" wrong response to these concerns and those D90 or V100 that would provide for a treatment site" be reported as MEs.

raised by other commenters, the NRC medically acceptable implant, as Response: The rule text was modified removed the absorbed dose-based ME suggested by the commenter. The term based on these comments and a reporting criterion in § 35.3045(a)(2)(iii). "D90" is the dose reported in Gray or recommendation from the ACMUI. The as a percentage of the prescribed dose NRC agrees that typical permanent Issue: Source-Strength-Based Criteria as implant procedures result in some that covers 90 percent of the target the Metric for Permanent Brachytherapy volume. The term "V100" is the sources being implanted outside the Versus Absorbed Dose-Based Criteria treatment site as described in the WD.

fractional volume of the target usually Comment: Two commenters stated reported as a percentage that receives In accordance with § 35.3045(a)(2)(ii),

that the use of source-strength based 100 percent of the prescribed dose. The an ME has not occurred when less than criteria as the metric for permanent effect of making the commenter's 20 percent of the sources are implanted brachytherapy is directly proportional proposed change would be a outside the treatment site. The NRC also to the absorbed dose, and consistent requirement to report as an ME under agrees that § 35.3045(a)(2)(v)(C), as with nuclear medicine administrations § 35.3045(a)(2) any permanent implant proposed [now § 35.3045(a)(2)(iii)(C)],

of radiopharmaceutical therapy whose that is not deemed medically appears to be in conflict with the purpose is to achieve a prescribed tumor acceptable. The NRC believes that such provisions of § 35.3045(a)(2)(ii). To dose. The commenters also pointed out a requirement could risk interfering ensure that the provisions of that dose is not factored into the ME with the practice of medicine. The NRC § 35.3045(a)(2)(iii)(C) can be definition for radiopharmaceuticals, and determined, for reasons explained in distinguished from those in has been an auditable measure by response to other comments, that the § 35.3045(a)(2)(ii), the NRC has changed inspectors since the definition of dose-based criteria should be removed § 35.3045(a)(2)(iii)(C) to read: "Sealed "misadministration" that was created and not replaced. source(s) implanted directly into a decades ago. location discontiguous from the Response: The rule text was modified Issue: Sealed Source(s) Directly treatment site, as documented in the based on this and other comments. Delivered to the Wrong Treatment Site post-implantation portion of the WD."

While the NRC agrees that source Comment: Several commenters expressed concern with the proposed Issue: Sources That Were Implanted in strength is a major factor impacting rule text in § 35.3045(a)(2)(v)(C), which the Correct Site but Migrated Outside absorbed dose for permanent requires reporting sealed source(s) the Treatment Site brachytherapy, the absorbed dose is determined by a combination of source directly delivered to the wrong Comment: Several commenters noted strength and spatial positioning. Despite treatment site as an ME. Two that § 35.3045(a)(3) currently includes this fact, in response to this comment commenters specifically pointed out the phrase, "excluding, for permanent and different concerns raised by other that § 35.3045(a)(2)(v)(C) is in direct implants, seeds that were implanted in commenters, the NRC determined that a conflict with § 35.3045(a)(2)(ii), which the correct site but migrated outside the source-strength based criterion is allows for 20 percent of the implanted treatment site" but that this provision appropriate to define MEs for source activity to be outside of the was not included in the proposed rule.

permanent implant brachytherapy and intended treatment site. Further, the They said that removal of this provision commenters pointed out that, as "will cause numerous spurious reported removed the absorbed dose-based ME reporting criterion in § 35.3045(a)(2)(iii) proposed, this section would require MEs which will be unnecessarily and (iv). that even a single sealed source directly burdensome and time consuming to the delivered to the wrong treatment site be NRC and the licensee without Issue: Require Licensees To Establish reported as an ME. Several commenters increasing patient safety." One Certain Documented Criteria for a pointed out that when performing a commenter stated that migration of Medically Acceptable Implant Instead of normal implant procedure, sources can seeds from a prostate treatment site is a the Absorbed Dose to Normal Tissues occasionally be deposited outside the potential clinical occurrence. The Comment: Two commenters suggested treatment site due to various factors commenters asked the NRC to restore the modification of § 35.3045(a)(2) to such as uncertainties in intraoperative the provision for migrated seeds.

remove both criteria for absorbed dose imaging, patient motion, suction of One commenter expressed concern to 5 contiguous centimeters of tissue seeds due to needle withdrawal, or seed that failure to include an exclusion for and require instead that licensees migration. For example, one commenter migrated sources would require establish documented criteria such as stated that because in a prostate implant reporting as ME permanent implant D90 or V100 that provide for a 90 to 100 seeds are routinely implanted, brachytherapy procedures in which the medically acceptable permanent "[a] seed could end up in tissue sources were placed correctly then implant. surrounding the prostate, in the bladder, migrated. The commenter suggested that Response: The rule text was modified or in the rectum. The overall impact cc... images taken 15, or 30, or 60 days based on other comments. The rule text would be numerous MEs of no clinical after an implant cannot unambiguously

33076 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations determine the placement of sources at believes that these questions will force seed migration) that are outside of the the time of implant. Only placement AUs to define a treatment site "with physician's control. The commenter meeting Medical Event criteria in huge margins for seed drift." noted that the exception for MEs

§ 35.3045(a)(2) at time of implant should The commenter also asked what rule resulting from patient intervention does constitute a Medical Event." The would apply if all seeds are in the not address procedure-related causes commenter also stated that some treatment site, but "badly distributed that are outside of the physician's licensees do not offer permanent around the periphery." The commenter control. The commenter recommended brachytherapy because of a concern that stated that this could result in a "bad that § 35.3045(a)(2) be revised to read:

MEs could occur due to circumstances cold spot" in the treatment site dose "For permanent implant brachytherapy, beyond their control, and the damage distribution and noted that many the administration of byproduct that can result from the publicity permanent prostate implants "show this material or radiation from byproduct surrounding an ME. tendency naturally 30 days after material (not resulting from patient-One commenter noted that in the implant." related or procedure-related causes-2002 revisions to 10 CFR part 35, the The commenter stated that these such as edema, source migration after term "recordable event" was eliminated issues pertain to the practice of placement or imaging uncertainties) that and the term "misadministration" was medicine and should not be regulated results in..." The commenter changed to "medical event." The by the NRC. expressed concern that, without an commenter stated that the definition (of Response: No change was made to the exception for patient-related and an ME) did not change. The definition rule text based on this comment. The procedure-related causes, "many compares the treatment administered to NRC has not established a cutoff medically acceptable procedures will be what the AU intended to administer. distance for "drift" or source migration. labeled as MEs, contrary to our The commenter expressed concern that, The AU defines the treatment site in the understanding of the NRC's intent."

as proposed, a treatment could be WD in any way he or she believes to be Response: No change was made to the identified as an ME if the seeds moved medically appropriate, including any rule text based on this comment. The after they were implanted correctly. The margins. The NRC agrees that migration NRC did not modify the rule to include commenter stated that the proposed rule of sources that were implanted into the exceptions for patient-related and as written may inhibit a physician from correct site should not be considered an procedure-related causes (other than helping a patient if migration of seeds ME. In response to other comments, the seed migration) that are outside of the is not taken into account in defining an rule text at § 35.3045(a)(2) was changed physician's control. Factors outside of ME for permanent implant to restore the exclusion to ME reporting the physician's control, such as edema brachytherapy implants. requirements for sources that were and imaging uncertainties, should have Response: The rule text was modified implanted in the correct site but limited impact under the source-based on these comments. The rule text migrated outside the treatment site. In strength based ME reporting criteria in in § 35.3045(a)(2) was modified to response to other comments, the rule § 35.3045(a)(2)(ii).

restore the provision for sources that text at § 35.3045(a)(2)(v)(C) [now were implanted in the correct site but § 35.3045(a)(2)(iii)(C)] was also changed Issue: Error in Calculating the Total to replace the phrase "[s]ealed source(s) Source Strength migrated outside the treatment site. The NRC agrees that migration of sources directly delivered into the wrong Comment: One commenter stated that that were implanted in the correct site treatment site" with "[s]ealed source(s) it is not clear why the ME criterion in should not be considered an ME. implanted directly into a location § 35.3045(a)(2)(v)(E), i.e., "[a] 20 percent Comment: One commenter expressed discontiguous from the treatment site, as or more error in calculating the total concern about the phrase "outside of the documented in the post-implantation source strength documented in the pre-treatment site" at § 35.3045(a)(2)(ii). portion of the written directive." implantation portion of the written This is the proposed criterion to define The NRC agrees that the dose directive," was proposed. The as an ME a permanent implant distribution within the treatment site is commenter believes that this criterion brachytherapy administration that not a suitable ME criterion because it was based on an "ACMUI proposal of results in the total source strength can vary over time and is not fully using the wrong activity or source administered outside of the treatment under the control of the AU. In response strength (+/- 20 percent) as specified in site exceeding 20 percent of the source to other comments, the NRC revised the the written directive," and noted that strength documented in the post- permanent implant brachytherapy ME the ACMUI did not specify whether this administration WD. The commenter criteria at § 35.3045(a)(2) to be based is "wrong" as compared to the pre-noted that, for permanent prostate only on total source strength, not dose. implantation or post-implantation implants, most of the seeds are As a result, no ME has occurred if at portion of the WD. The commenter purposely implanted in and around the least 80 percent of the sources are in the stated that the requirement in periphery of the gland and many can treatment site, regardless of the § 35.3045(a)(2)(v)(E) appears to be a drift. The commenter stated that 20 distribution of the sources or the duplication of the intent of percent of the sources may drift, even existence of a "cold spot" in the dose § 35.3045(a)(2)(i) and recommended when linked together, and asked if the distribution. The NRC agrees, and it is deleting § 35.3045(a)(2)(v)(E).

NRC has established a cutoff distance the NRC policy, that the NRC should not Response: The rule text was modified for drift. The commenter also expressed (and does not) regulate the practice of based on this comment. The rule text in concern about the statement that if even medicine. § 35.3045(a)(2)(v) was revised to delete one source is apparently "directly the ME criterion described in implanted . . . into another (distant Issue: Medical Event Definition Should § 35.3045(a)(2)(v)(E), "[a] 20 percent or from the treatment site) location," it is Allow an Exception for Causes Outside more error in calculating the total an ME, and noted that it may be difficult of the Physician's Control source strength documented in the pre-to distinguish a seed that drifted a long Comment: One commenter suggested implantation portion of the written distance from one that was directly that the ME definition should allow directive." However, the NRC implanted into a location distant from exceptions for patient-related and determined that § 35.3045(a)(2)(v)(E) the treatment site. The commenter procedure-related causes (other than was not a duplication of

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33077

§ 35.3045(a)(2)(i), but agrees that the example, it is possible for an ME to centimeters have exceeded an expected provision is not needed. As stated by occur if there was an error of 20 percent absorbed dose by 50 percent; (3) that the commenter, this criterion was or more in the total source strength different licensees use different originally recommended by the ACMUI. ordered and administered. absorbed dose metrics to determine a In July 2005, the ACMUI submitted to successful implant; (4) that the dose to Issue: Comparison of Source Strength the NRC a set of guiding principles to 5 contiguous cubic centimeters Specified in the Pre-Implantation assist the NRC staff in defining a rule to introduced by the NRC is arbitrary and Written Directive capture MEs from permanent implant not based on any clinical data; and (5) brachytherapy procedures. One of the Comment: Several commenters stated that the ACMUI in 2008 recommended principles recommended a limited dose- that ME reporting for permanent a source strength ME definition for based ME criterion: "[a]n implant is a implant brachytherapy must be based permanent implants and explicitly medical event if the dose calculations on the source strength in the post- stated it should not include absorbed used to determine the total source administration WD as described in dose criteria.

strength documented in the written § 35.40(b)(6)(ii). Some of the Response: The rule text was modified directive are in error by more than 20 commenters stated that the proposed based on this comment. The rule text in percent in either direction." The changes to § 35.3045 wrongly specified § 35.3045(a)(2) was modified to remove ACMUI explained that this "limited" the pre-implantation WD. § 35.3045(a)(2)(iii) and (iv), which ME dose pathway would "focus only on Response: No changes were made in would have required the assessment of preplanning or intraoperative planning, response to these comments. The source the absorbed dose to normal tissue not post-implant evaluation." Because strength comparisons for the ME outside and within the treatment site.

the revised ME criteria are based on reporting criteria in § 35.3045(a)(2)(i) The rule text, as proposed in post-implant evaluations, the NRC and (ii) are with the source strength § 35.40(b)(6)(i), contains a requirement agrees that the criterion at specified in the post-implantation WD. to include the intended absorbed dose

§ 35.3045(a)(2)(v)(E) is not needed. Although § 35.3045(a)(2)(iii) of the to the treatment site. However, in Comment: One commenter stated that proposed rule included an absorbed response to other comments, the NRC the criterion in § 35.3045(a)(2)(i) is dose comparison with information in has decided to remove this requirement consistent with clinically relevant the pre-implantation WD, the NRC from the final rule. The commenter is circumstances. The commenter removed this criterion in response to correct that in 2008 the ACMUI expressed concern that this is exactly other comments. Also, recommended source-strength based the same as the requirement in § 35.3045(a)(2)(v)(E) of the proposed criteria. However, in 2012, the ACMUI

§ 35.3045(a)(2)(v)(E). The commenter rule included a calculated total source recommended the proposed "hybrid" noted that the rationale is unclear for strength with the pre-implantation WD, criteria for reporting MEs for permanent comparing against the post-implantation but NRC removed this criterion in implants, and that recommendation was source strength in § 35.3045(a)(2)(i) and response to different comments. As a endorsed by the American Association comparing against the pre-implantation result, § 35.3045(a)(2) no longer requires for Radiation Oncology. The NRC source strength in § 35.3045(a)(2)(v)(E). any comparisons with the pre- understands the commenter's concerns The commenter also stated that current implantation WD. that regulatory personnel may have practice is "to assay a portion of the difficulty assessing permanent implants Issue: Support Source Strength-Only seeds to ensure the total source strength under the proposed rule, and that Approach for Medical Event Criteria for is as ordered, which would prevent both different licensees may use different Permanent Implants of these medical events from occurring." criteria for determining a successful Response: The rule text was modified Comment: One commenter supported implant. The NRC agrees that the based on this comment. The rule text in the shift to use total source strength proposed absorbed dose-based criteria

§ 35.3045(a)(2)(v) was revised to delete administered (activity-based) ME are not based upon clinical data. In the ME criterion in § 35.3045(a)(2)(v)(E) criteria for permanent implants rather response to these concerns and those of the proposed rule: "[a] 20 percent or than dose delivered (dose-based) criteria raised by other commenters, the NRC more error in calculating the total for permanent brachytherapy implants. removed the absorbed dose-based ME source strength documented in the pre- Response: The comment supports reporting criterion in § 35.3045(a)(2)(iii) implantation portion of the written language in the rule; therefore, no and (iv).

directive." Although these criteria are response is required. Comment: Two commenters stated not exactly the same, the NRC agrees Comment: One commenter expressed that in 2008, the ACMUI recommended with the commenter that the criterion at several concerns related to the proposed source strength ME definition for

§ 35.3045(a)(2)(v)(E) is not needed dose-based portion of the criteria for permanent implants. The commenters because such situations will almost permanent implant brachytherapy ME stated that nevertheless, the NRC staff always be captured by the criteria at reporting. The commenter added an absorbed dose-based criterion

§ 35.3045(a)(2)(i) and (a)(2)(ii). In the recommended that any ME reporting for to the definition, and the Commission rare situation where a calculation error permanent implant brachytherapy be rejected it. The NRC held national would not be captured by the criteria at based solely on a source-strength based stakeholder workshops in 2011 on this (a)(2)(i) or (a)(2)(ii)-for example, definition for the WD as recommended issue and the overwhelming consensus because the calculation error was later originally by the ACMUI and the at each workshop attended by corrected-then the NRC would not radiological societies rather than the professional organizations and deem it appropriate to report the proposed hybrid definition based on radiological professionals was to have calculation error itself as an ME. source strength and absorbed dose. The source-strength ME reporting criteria The NRC considered the commenter's commenter's concerns included: (1) rather than absorbed dose-based criteria.

statement that these types of MEs would That the WD has no absorbed dose The commenters also pointed out that be prevented by assaying a portion of specification; (2) that regulatory the ACMUI presentations at these the seeds to ensure the total source inspectors do not possess the expertise workshops stated that source strength strength is as ordered and concluded to assess permanent seed implants and criteria were preferable. The that this may not be fully correct. For determine if any 5 contiguous cubic commenters recommended that the NRC

33078 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations provide a more comprehensive general public and to ensure that of evaluating the dose coverage to the regulatory basis for deviating from these radionuclides are used in accordance target and organs at risk."

recommendations. One of the with the physician's directions. The Response: No change was made to the commenters stated that the NRC needs NRC disagrees that it should require rule text based on this comment. This is to base the ME definition on source licensees to establish a peer review one of the few comments NRC received strength rather than the proposed hybrid process for assessing MEs. The licensee that supported the dose-based ME definition based on source strength and makes the determination of the actual or reporting criteria. The NRC received absorbed dose, by removing potential harm to patients that might other comments that identified

§ 35.41(b)(6)(iii) and (iv) and amending result from an ME. However, the NRC's technical limitations associated with the

§ 35.3045(a)(2). position is that an ME may be indicative use of a dose-based ME reporting Response: The rule text was modified of a potential problem in a medical criteria for dose to normal tissue from based on these comments. The rule text facility's use of radioactive materials permanent implant brachytherapy. The in § 35.3045(a)(2) was modified to even if it does not actually result in NRC eliminated the dose-based criteria remove § 35.3045(a)(2)(iii) and (iv), harm to the patient. in § 35.3045(a)(2)(iii) and (iv) for normal which would have required the In response to the portion of this tissue for reporting MEs. Therefore, the assessment of the absorbed dose to comment concerning dose to normal dose to the organs at risk does not need normal tissue outside and within the tissue and other comments, the NRC to be determined for ME reporting treatment site. A corresponding change removed the absorbed dose-based ME purposes.

was made to the rule text in reporting criteria for normal tissue in Issue: Concerns Regarding Regulators'

§ 35.41(b)(6) to remove § 35.41(b)(6)(iii) § 35.3045(a)(2)(iii) and (iv).

Comment: One commenter suggested Training and Ability To Inspect and and (iv). The NRC agrees with the Assess Permanent Implants Under the commenters' stated timeline of events that the reporting criteria for permanent implants should be the "dose coverage Proposed Criteria regarding ME reporting criteria recommendations. However, in 2012, to the intended target," which is a much Comment: Several commenters the ACMUI recommended the proposed more meaningful indicator of the quality expressed concerns about the ability of "hybrid" criteria for reporting MEs for of an implant. The commenter suggested regulators to assess licensees' permanent implants, and that the use of "D90" and provided the D90 implementation of the proposed ME recommendation was endorsed by the definition from the AAPM Task Group reporting criteria in § 35.3045(a)(2)(iii)

American Association for Radiation 137: "the minimum dose to the hottest and (iv). One commenter asked if Oncology. This recommendation was 90 percent of the target volume." inspectors are capable of evaluating the one of the key components of the NRC's Response: No change was made to the methods used by the licensee to regulatory basis for the proposed rule. In rule text based on this comment. This is determine the 5 contiguous cubic response to other comments, the NRC one of the few comments NRC received centimeter volume of normal tissue and removed the absorbed dose-based ME that supported dose-based ME reporting related dosimetry. Another commenter reporting criterion in § 35.3045(a)(2)(iii) criteria for the treatment site. The NRC stated that the proposed change will and (iv) and the requirements in understands that "D90" is one of the require substantial retraining of

§ 35.41(b)(6)(iii) and (iv) for absorbed dose-based parameters that is regulatory personnel to make determination of absorbed dose to an accepted professional practice for determinations based on the new normal tissue outside and within the assessing the clinical quality of an criteria. The commenter stated "[t]his is treatment site. implant. However, the NRC also unduly burdensome and serves no real understands that "D90" is not the only value since doses may be clinically off Issue: Alternate Recommendations for dose-based parameter that is accepted by 200 percent and still be viable for ME Definitions for Permanent Implants and used. The NRC also received treatment." Two other commenters Comment: One commenter suggested numerous other comments that stated that most regulatory personnel do that the NRC require licensees to identified technical limitations not have the tools or expertise to assess establish a "peer review" process in associated with the use of dose-based a permanent implant and determine if conjunction with the requirements that ME reporting criteria for permanent any 5 contiguous cubic centimeters have licensees establish procedures that implant brachytherapy. Therefore, the exceeded an expected absorbed dose by provide "high confidence" that the WD NRC revised the permanent implant 50 percent. The commenters also is fulfilled. The commenter stated that brachytherapy ME reporting criteria in expressed concern that the NRC has MEs should be rare mistakes because § 35.3045(a)(2) to be based only on total proposed a dose metric that is not an the procedures are required to be source strength, not dose. established standard of clinical practice performed by physicians that have the Comment: One commenter suggested and appears to infringe on the practice required T&E. The commenter also that the reporting criteria for permanent of medicine.

stated that the NRC should not try to implants should be based upon the dose Response: The rule text was modified regulate the "medicine side" and that to the organs at risk. The commenter based on these comments. The rule text the NRC's determination of" 'actual or provided the examples of the bladder in § 35.3045(a)(2) was modified to potential harm to a patient' and review and the rectum as organs at risk when remove § 35.3045(a)(2)(iii) and (iv),

of normal tissue doses are not needed." treating the prostate with permanent which would have required the Response: No change was made to the implants. The commenter stated that assessment of the absorbed dose to rule text based on this comment. The this approach would hold the normal tissues outside and within the NRC agrees that the NRC should not brachytherapist (AU) accountable for treatment site. The NRC understands the regulate the practice of medicine. In protecting the organs at risk but not commenters' concerns that regulatory accordance with the Commission's penalize the AU for intentionally personnel may have difficulty assessing Medical Use Policy Statement published implanting sources in normal tissue for permanent implants under the proposed August 3, 2000 (65 FR 47654), the NRC treatment purposes. The commenter rule and that the NRC proposed a 5 does not intrude into medical also stated that "[a]nother benefit of contiguous cubic centimeter volume decisionmaking except as necessary to both of these suggestions is that current dose metric that is not an established provide for the safety of workers and the brachytherapy software offers a method standard of clinical practice. In response

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33079 to these concerns and different concerns criterion in § 35.3045(a)(2)(ii) because more "loosely," an ME may not have to raised by other commenters, the NRC its vendor's software does not currently be reported.

removed the absorbed dose-based ME have a satisfactory method of Response: No change was made to the reporting criteria in § 35.3045(a)(2)(iii) determining whether 20 percent of the rule text based on this comment. The and (iv). source strength is outside of the AU defines the treatment site in the WD treatment site. in the way he or she believes to be Issue: Applicability of the Proposed medically appropriate, including any Criteria to Y-90 Microspheres Response: No change was made to the rule text based on this comment. The margin. The AU may define the Comment: Several commenters NRC understands that AUs may treatment site to include all tissues into questioned whether the new permanent intentionally implant sources into which sources have been purposely implant brachytherapy requirements at surrounding normal tissues. The AU implanted. The NRC has determined

§ 35.3045 apply to the use of Y-90 defines the treatment site in the WD in that the definition of the treatment site microspheres under § 35.1000. One any way he or she believes to be is a matter of medical judgment.

commenter stated that these new medically appropriate, including any Comment: One commenter stated that requirements cause confusion when margin or PTV structure. The NRC the identification of the "treatment site" read in conjunction with the NRC acknowledges that treatment planning is not well defined. The commenter licensing guidance for Y-90 software may not have an automated stated that some facilities identify the microspheres, which describes them as method to determine whether 20 treatment site as the prostate gland only "manual brachytherapy sources used for and plan a dose margin around the percent of the source strength is outside permanent implantation therapy." The of the treatment site. It may be necessary prostate, while other facilities include a commenters suggested that the rule for licensees to perform a manual planning target volume (PTV) structure language be clarified to include a determination of the number of sources around the prostate as the treatment site definition of the types of sources to outside the treatment site in comparison and target coverage to that structure.

which the permanent implant with the number of sources within the Response: No change was made to the brachytherapy requirements apply so rule text based on this comment. The treatment site.

that it is clear whether they apply to AU defines the treatment site in the WD Comment: One commenter stated that Y-90 microspheres. in the way he or she believes to be Response: No change was made to the the requirement at § 35.3045(a)(2)(ii) would have positive impact if the medically appropriate, including any rule text. The term "permanent implant margin or PTV structure.

brachytherapy" is used to refer to definition of treatment site is clarified to manual brachytherapy procedures include implantation of seeds in Issue: The Complexity of the Medical performed in accordance with § 35.400. interstitial tissue, and not critical Event Reporting Requirements as The NRC considers Y-90 microspheres structures. The commenter believes that Currently Proposed May Create to be manual brachytherapy sources; this criterion is consistent with Confusion however, they have unique properties clinically relevant circumstances when Comment: One commenter stated that that prevent them from being regulated several seeds are accidentally placed in the proposed ME reporting requirements under all the provisions of § 35.400 and critical organs to the extent that they are complex and may create confusion are regulated under § 35.1000. could cause a medically significant for regulators and the regulated Consequently, the ME reporting event to the patient. community when applied to permanent requirements for permanent implant Response: No change was made to the prostate implant procedures.

brachytherapy do not apply to the use rule text based on this comment. The Response: The rule text was modified of Y-90 microspheres. NRC determined that revising the based on other comments. The NRC definition of the treatment site to acknowledges the commenter's concern Issue: Defining the Treatment Site in the include implantation of sources in regarding the complexity of the ME Written Directive interstitial tissue, and not critical reporting requirements. The NRC Comment: The commenter expressed structures, is not warranted. The AU received several comments raising concern that under the proposed rule in defines the treatment site in the way he concerns about specific portions of the

§ 35.3045(a)(2)(ii), a high quality or she believes to be medically proposed rule and changes were made implant with excellent dose statistics, appropriate, which in some cases may in response to these comments. One of where many seeds are implanted include intentional implantation of the major changes was to remove the outside the Planning Target Volume sources in critical structures. The NRC requirements in § 35.3045(a)(2) related (PTV) to ensure adequate dose coverage, has determined that the criterion in to absorbed dose to normal tissue. The would be viewed as an ME. The § 35.3045(a)(2)(ii) appropriately NRC believes that these changes have commenter stated that its prostate captures those instances where reduced the complexity of the ME implant program allows for the medically significant events may occur. reporting requirements.

implantation of 1-125 seeds into normal The NRC is not aware of cases where tissues surrounding the prostate so that medically significant events have Issue: NRC Should Create a New Section the prescribed dose covers a treatment occurred while 20 percent or less of the in 10 CFR Part 35 for Permanent margin (PTV) in addition to the prostate, source strength was implanted outside Implant Brachytherapy Regulations in order to treat extra-capsular extension the treatment site. Only of prostate cancer. The commenter Comment: One commenter stated that Comment: One commenter provided recommendations from the compliance with the requirements in recommended that the NRC create a American Association of Physicists in § 35.3045 is dependent on how the new section in 10 CFR part 35 for Medicine Task Group Report 137 and tumor volume is defined by the permanent brachytherapy implants the American Brachytherapy Society physician. The commenter explained only. This new section should include Prostate Low-Dose Rate Task Group that if one AU defines the treatment site the procedural requirements included in Report on treating a margin of tissue with "tight borders" the licensee may § 35.41(b)(6) and ME reporting criteria outside of the prostate. The commenter need to report an ME. However, if specific to permanent brachytherapy also expressed concern with the another AU defines the treatment site implants included in § 35.3045 of the

33080 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations proposed rule. The commenter stated the preamble of the final rule that The NRC determined that Compatibility that, if the NRC decides to create this activity-based ME metrics are an Category B is not the appropriate new separate section, then the ME essential program element, and that designation because the ME reporting requirements for permanent dose-based metrics are unacceptable for criteria, while important to the effective brachytherapy implants should be use. The commenter stated that the and orderly regulation of agreement separated and handled in a rulemaking absorbed dose-based ME metrics are not material on a nationwide basis, do not separate from the remainder of the "imore restrictive" per se, but are have significant direct transboundary proposed amendments, to allow the unsuitable and confusing when implications. The essential objective of NRC to finalize all other proposed misapplied to the specific procedures in § 35.3045 is to maintain a consistent amendments without delay. question. national program for reporting MEs.

Response: No change was made to the Response: The NRC has discussed the Agreement State use of dose-based placement of regulations related to program element contained in § 35.3045 criteria for permanent implant permanent implant brachytherapy. The and the essential objective of this brachytherapy ME reporting would be requirements for procedures requiring a program element in Part I, item 4 of this inconsistent with this essential objective WD, and the requirements for ME section based on this comment. The because the NRC has determined that reporting appear in two different program element contained in § 35.3045 dose-based criteria would result in the subparts of part 35-Subpart B-General is ME reporting, not activity-based ME reporting of insignificant events.

Administrative requirements, and metrics. The essential objective of this Therefore, for national reporting, Subpart M-Reports. To separate the program element is to maintain a Agreement States' use of dose-based permanent implant brachytherapy consistent national ME reporting reporting criteria either instead of or in requirements from these subparts and program. In the final rule, the ME addition to activity-based reporting put them in a separate section would criteria for permanent brachytherapy is criteria for permanent implant disrupt the logical flow of 10 CFR part activity-based and not dose-based. Dose- brachytherapy would not be compatible

35. based ME reporting criteria for with § 35.3045.

permanent implant brachytherapy Comment: One commenter expressed Issue: The Compatibility Designation for would conflict with the essential support of the Compatibility Category B Medical Event Reporting Under objective of maintaining a consistent designation for § 35.3045 and noted

§ 35.3045 national reporting program because it that, as discussed by the NRC in the Comment: One commenter stated that would result in insignificant events proposed rule, some medical licensees the WD requirements under being reported as MEs. As explained in practice at multiple locations, some of

§ 35.40(b)(6) and the procedures for Part I, item 4 of this section, consistency which are NRC-regulated and some of permanent implant brachytherapy in the national reporting program allows which are Agreement State-regulated.

required under § 35.41(b)(6) should be the NRC to identify trends or patterns, The commenter stated that a deemed Compatibility Category B identify generic issues or concerns, Compatibility Category B designation (rather than Compatibility Category C) recognize inadequacies or unreliability would allow for uniformity of practice such that the rules are uniform from one of specific equipment or procedures, and procedures across the country. The state to another to minimize confusion. and determine why an event occurred commenter further suggested that to The commenter stated that because over and whether any actions are necessary make the move from Compatibility 90 percent of medical licensees are to improve the effectiveness of NRC and Category C to B smooth, the NRC should under Agreement State authority, Agreement State regulatory programs. define the "essential objectives" of anything less than Compatibility Dose-based ME reporting criteria would § 35.3045 such that the Agreement Category B makes these changes "an result in inconsistent reporting of States' adoption of the new definition is over-regulation of the minority." permanent implant brachytherapy MEs, not met with unnecessary delays.

Response: The WD requirements and thus would disrupt these efforts. Response: The NRC has determined under § 35.40(b)(6) and the procedures Comment: One commenter stated that that Compatibility Category C is the for permanent implant brachytherapy they support the Compatibility Category appropriate category for § 35.3045, for required under § 35.41(b)(6) are B designation for ME reporting, in the reasons explained in response to designated as Compatibility Category agreement with the opinion of the another comment and in Part I, item 4 Health and Safety (H&S). This ACMUI and for the reasons provided in of this section. The essential objective of designation was not changed in the the proposed rule. The commenter § 35.3045 is to maintain a consistent proposed rule. The H&S category stated that, considering the details and national reporting program, as further contains program elements that are not clinical implications of the prostate explained in Part I, item 4 of this required for compatibility, but are implant procedures, it only makes sense section.

identified as having a particular health to have activity-based criteria for an ME. Comment: One commenter, in support and safety role (i.e., adequacy) in the The commenter believes that there is of the Compatibility Category B, stated regulation of agreement material within merit in consistent rules for subjects that they recognize that the Agreement the State. The commenter appears to be that have significant implications, such States oppose a change in Compatibility referring to the compatibility as the criteria for an ME, and Category, citing state legislative designation of ME reporting under standardization should remove requirements, the difficulty in changing

§ 35.3045, which is designated as uncertainty and confusion. state regulations, and the fact that Compatibility Category C and which the Response: The NRC agrees with the Agreement States do not perceive a final rule continues to designate as commenter that activity-based criteria problem with the current dose-based Compatibility Category C. are appropriate for MEs for permanent definition. The commenter believes that Comment: One commenter stated that implant brachytherapy procedures, these concerns are outweighed by the if the NRC were to revert to a lower- including the prostate implant importance of having a consistent than-proposed compatibility category procedures. As discussed earlier in this definition throughout the country to (i.e., Compatibility Category C instead of section, the NRC has determined that prevent confusion and unnecessary B), then they recommend, as a last Compatibility Category C is the reporting of otherwise medically resort, that the NRC explicitly state in appropriate designation for § 35.3045. acceptable procedures as MEs. The

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33081 commenter expressed concern that a this would confuse the regulated country. The NRC designates regulatory Compatibility Category C designation community and continue to weaken program elements as Compatibility would allow Agreement States to confidence in the significance of Category B if they have significant direct implement unnecessarily more reported permanent brachytherapy MEs. transboundary implications, not simply restrictive definitions that classify Response: As explained in response to for the purpose of ensuring uniformity medically acceptable procedures as other comments, the NRC has across the country with respect to a MEs. determined that Compatibility Category program element. The effect of a Response: The NRC understands the C is the appropriate category for Compatibility Category B designation is importance of having consistent ME § 35.3045. Under Compatibility Category essentially uniformity across the reporting criteria throughout the C, Agreement States will not be able to country with respect to a program country to prevent confusion and maintain alternative ME criteria not element, because this designation unnecessary reporting of otherwise listed in the revised § 35.3045, if those requires Agreement States to adopt medically acceptable procedures as ME. criteria would create conflicts or program elements that are "essentially This consistency is necessary to meet inconsistencies in the national reporting identical" to that of the NRC. This the essential objective of § 35.3045, program. The NRC understands the uniformity is necessary because a which is to maintain a consistent commenter's concern that alternative program element has significant direct national reporting program. The NRC ME criteria could weaken the public's transboundary implications. As disagrees that Compatibility Category B confidence in the significance of discussed in Part I, item 4 of this is the appropriate category for § 35.3045 permanent implant brachytherapy MEs. section, the NRC has determined that and instead has determined that Therefore, the NRC has identified dose- ME reporting does not rise to the level Compatibility Category C is the based criteria as an example of of having significant direct appropriate category. Therefore, alternative ME reporting criteria that transboundary implications. Therefore, Agreement States are required to adopt would capture insignificant events as Compatibility Category B is the essential objectives of this provision, MEs and create a conflict and inappropriate.

but are not required to adopt essentially inconsistency in the national reporting The NRC has determined that identical ME reporting criteria. The program. Compatibility Category C is the Agreement States have the flexibility to Comment: Several commenters stated appropriate designation for § 35.3045.

include, for example, a shorter reporting that their medical practices are affected Under Compatibility Category C time in their ME reporting criteria, but by the compatibility category assigned designation, the essential objectives of the use of dose-based ME reporting to § 35.3045. They said that they are the regulation should be adopted by the criteria for permanent implant pleased with the Commission's decision State to avoid conflicts, duplications or brachytherapy would create conflicts to move § 35.3045 from Compatibility gaps. The essential objective of and inconsistencies with respect to the Category C to Compatibility Category B. § 35.3045 is to maintain a consistent national reporting program, because it The commenters stated that it is national ME reporting program.

would capture insignificant events as essential that § 35.3045 be defined and Agreement States should ensure that MEs. implemented in a consistent manner their ME reporting criteria do not Comment: Two commenters in across the country. The commenters conflict with or create inconsistency support of Compatibility Category B stated that, as the NRC noted in the within this program.

stated that because over 90 percent of proposed rule, some medical licensees Comment: One of the Agreement medical licensees are under Agreement practice at multiple locations, some of States stated that all MEs are local State authority, anything less than which are NRC-regulated and some of events and are not transboundary Compatibility Category B makes the which are Agreement State-regulated. events, regardless of their significance.

proposed changes an "over-regulation of The commenters stated that there are The commenter stated that even the minority." The commenters stated many practices that extend beyond one multiple events with a common root that it would be counterproductive for particular jurisdiction, usually when the cause are considered local events and Agreement States to maintain main center is near a state border. The each licensee is required to submit an alternative ME criteria not listed in the commenters further stated that they ME report to its licensing authority. The revised § 35.3045. The commenters expect this situation to increase commenter also stated that all MEs are further stated that because certain significantly in the coming few years as reported in the Nuclear Materials Event healthcare systems may be providing the consolidation of healthcare Database, so NRC is notified of all services in both NRC and Agreement institutions into larger entities events that meet the NRC's ME criteria.

State jurisdictions, § 35.3045 should be continues to accelerate. Therefore, a Response: The NRC acknowledges designated as Compatibility Category B. Compatibility Category B designation that, from the perspective of a single One commenter said that they strongly would allow for uniformity of practice medical facility, MEs appear to be local support the proposed designation of and procedures across the country. events only. The NRC has determined Compatibility Category B for § 35.3045, Response: The NRC understands the that ME reporting does not rise to the thereby requiring Agreement States to commenters' concern that § 35.3045 be level of having significant direct adopt ME reporting and notification defined and implemented in a transboundary implications and; program elements essentially identical consistent manner across the country. therefore, Compatibility Category B is to NRC's. The commenter also stated As noted by the commenter, and as the inappropriate. However, to ensure that that it would be counterproductive for NRC noted in the proposed rule, some an Agreement State program meets the Agreement States to maintain medical licensees practice at multiple essential objective of § 35.3045 to alternative ME criteria not listed in the locations, some of which are NRC- maintain a consistent national ME revised § 35.3045. The commenter regulated and some of which are reporting program, the Agreement stated that if the dose-based ME Agreement State-regulated. States, for permanent implant reporting criteria were interpreted by The NRC disagrees that § 35.3045 brachytherapy treatments, should not the States as more "restrictive," and should be designated as Compatibility use the dose-based criteria. For the States were to continue to have some Category B to ensure uniformity of reasons explained in response to other manner of ill-fitting ME methodology, practice and procedures across the comments and in Part I, item 4 of this

33082 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations section, the use of dose-based criteria security of Category 1 or Category 2 procedures and no other permanent would create conflicts and sources, the commenter recommended brachytherapy procedures. The inconsistencies in the national ME that the compatibility category for the commenter further stated that the main reporting program. reporting requirements in § 35.3045 impetus for changing the compatibility Comment: Several commenters remain as Compatibility Category C. category for ME reporting appears to be opposing the proposed category B Response: It is true that currently the the multiple prostate implant MEs that designation for ME reporting questioned only reporting regulations with occurred at the Department of Veterans how a single medical incident at a Compatibility Category B designation Affairs facilities.

single facility can have "direct and are related to the security requirements Response: When drafting the ME significant effects in multiple and are located in other parts of 10 CFR. reporting requirements for permanent jurisdictions." They further added that However, that does not preclude the implant brachytherapy procedures at the Compatibility Category C NRC from categorizing reporting § 35.3045(a)(2), the NRC developed designation has been adequate for the requirements as Compatibility Category requirements that would apply to reporting requirements for radiography, B. Compatibility category designations permanent implant procedures for all irradiator, and well logging licensees do not hinge on whether a regulatory treatment sites, including prostate who routinely work in multiple requirement pertains to security or any implants. Although prostate implants jurisdictions. other discrete regulatory issue. Rather, are more common than other implants, Response: The NRC agrees that the the NRC assigns the appropriate the NRC staff in SECY-12-0053 Compatibility Category C designation category for each regulatory requirement recommended that the revised ME has been adequate for the reporting by considering and applying the criteria criteria apply to permanent implant requirements for radiography, irradiator, for Agreement State compatibility to procedures for all treatment sites, not and well logging licensees who work each particular regulatory requirement. only the prostate. The NRC has routinely in multiple jurisdictions. The For the reasons stated in response to determined that the prostate implant NRC has determined that Compatibility other comments and as discussed in procedure does not warrant a separate Category C is also the appropriate Section V., Public Comment Analysis, set of regulations and that including designation for § 35.3045. the NRC has determined that them in the ME reporting requirements The NRC acknowledges that, from the Compatibility Category C is the for permanent implant procedures for perspective of a single medical facility, appropriate designation for § 35.3045. all treatment sites is sufficient to ensure MEs appear to be local events only. The Comment: One commenter, in support that significant events involving NRC agrees that ME reporting does not of the Compatibility Category C prostate implants will be reported as have direct and significant effects in designation for ME reporting under MEs. As explained in response to other multiple jurisdictions, and therefore § 35.3045, stated that throughout comments and in Part I, item 4 of this agrees that Compatibility Category B is § 35.3045, the term "treatment site" is section, the NRC has determined that not the appropriate designation for used, that it is specifically defined in Compatibility Category C is appropriate

§ 35.3045. Therefore, the ME reporting § 35.2, and that this definition has been for all of § 35.3045, including criteria do not have to be essentially designated Compatibility Category C. permanent implant brachytherapy identical. However, the essential The commenter stated that since the procedures, such as prostate implants.

objective of § 35.3045 is to maintain a definition of "treatment site" is Comment: One Agreement State consistent national ME reporting remaining a Compatibility Category C, it stated that the proposed activity-based program, and to adopt this essential is possible for an Agreement State to ME reporting criteria should be added to objective Agreement States should adopt the essential objective of the the existing dose-based criteria, rather adopt ME reporting criteria that do not definition but it may be a slightly than replace it. The Agreement State create conflicts or inconsistencies in ME different definition. If the definition for stated that it would require licensees to reporting. The ME reporting program treatment site is slightly different in apply both criteria, and only those MEs ensures that the NRC and Agreement each jurisdiction, even if § 35.3045 is that meet the NRC's proposed activity-States are able to identify trends or changed to a Compatibility Category B, based criteria would be reported to the patterns, identify generic issues or the requirement may not be "essentially NRC. The commenter explained that concerns, recognize inadequacies or identical" in each jurisdiction. this approach would provide the states unreliability of specific equipment or Response: It is true that the with the needed flexibility to regulate procedures, and determine why an "treatment site" is defined in § 35.2 and both radioactive materials and machine-event occurred and whether any actions that this definition has been designated produced sources of radiation in a are necessary to improve the Compatibility Category C. While the consistent manner. The commenter also effectiveness of NRC and Agreement NRC may assign a particular stated that the ME reporting regulations State regulatory programs. Inconsistent compatibility category to certain should not be categorized as or conflicting ME reporting criteria definitions, the regulations in which Compatibility Category B because that would frustrate these purposes. these terms are used are not confined to would restrict the State's ability to Comment: Several commenters, in this same category. Instead, the NRC regulate the clinical aspects of the support of the Compatibility Category C assigns the appropriate category for each practice of medicine and patient designation for ME reporting under regulatory requirement by considering management.

§ 35.3045, stated that currently the only and applying the criteria for Agreement Response: The NRC has determined, reporting regulations with a State compatibility to each particular as recommended by the medical Compatibility Category B designation regulatory requirement. community, that the activity-based are related to the security requirements Comment: One commenter criteria are more appropriate for and are located in other parts of 10 CFR. recommended that, if the NRC insists on permanent implant brachytherapy The commenter also stated that all the changing the Compatibility Category to procedures than the dose-based criteria, reporting requirements found in 10 CFR B, then the rule language should be because activity-based criteria part 35 are Compatibility Categories C, changed to only require the specifically captures significant events H&S, or D. Since § 35.3045 is a reporting Compatibility Category B designation for reporting as MEs whereas dose-based requirement and does not relate to the for permanent prostate implant criteria would capture insignificant

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33083 events as well. The NRC has determined Comment: Two commenters agreed NRC determined that it is appropriate to that Compatibility Category C is the with the proposed revision but asserted report generator failures (i.e., when the appropriate designation for § 35.3045. that the proposed § 35.3204(a) initial eluate exceeds the permissible However, as explained in response to requirement to report to the NRC concentration listed in § 35.204(a)) to other comments and in Part I, item 4 of Operations Center within 30 days the NRC Operations Center. Reporting to this section, the NRC has determined should be shortened. One commenter the NRC Operations Center will permit that Agreement State use of dose-based stated that a shorter reporting the NRC to identify whether this is a criteria for permanent implant requirement was needed to more limited or more widespread failure of brachytherapy ME reporting would effectively address patient safety generators and share that information in result in inconsistencies and conflicts concerns. The other commenter stated a timely manner.

with the essential objective of § 35.3045, that in order to respond in a timely Comment: Several commenters which is to maintain a consistent manner to potential issues regarding the recommended that the NRC implement national ME reporting program. manufacturing and/or use of generators, the ACMUI recommendation to only the reporting period should be less than require licensees to report generator Section 35.3204 Report and 30 days. elution results with parent breakthrough Notification for an Eluate Exceeding Response: The rule text was modified beyond the § 35.204(a) limits to the Permissible Molybdenum-99, based on these comments. The rule text manufacturer/distributor, and not to Strontium-82, and Strontium-85 in § 35.3204(a) was revised to require both the manufacturer/distributor and Concentrations notification within 7 calendar days. The the NRC. The commenters stated that Comment: Two commenters NRC agrees that the time period for only the manufacturer/distributor supported the proposed generator notification should be shorter than the should be responsible for reporting "the elution breakthrough reporting proposed 30 calendar days. With the out-of-tolerance parent breakthroughs to requirements. short half-lives of the parent the NRC." The commenters also stated Response: The comment supports radionuclides, the NRC determined that that requiring the licensee to report to language in the rule; therefore, no a 7 calendar-day notification both the company and the NRC, while response is required. requirement is more appropriate. Seven the company also reports to NRC, is Comment: One commenter noted that calendar days gives the licensee an unnecessarily duplicative.

Tc-99m decays much faster than Mo-99; opportunity to evaluate its procedures, Response: A clarifying revision was therefore, every Tc-99m generator eluate measurements, and calculations to made to the rule text. The NRC requires determine if the generator actually that a licensee report to the NRC and the will eventually exceed the regulatory limit. Because of this, the commenter failed, i.e., the eluate actually exceeded generator distributor, which also may stated that the language in the proposed the permissible concentration, or if the sometimes be the manufacturer, when it licensee made an error. The shorter identifies a generator with an eluate rule text would require every eluate to reporting requirement would also exceeding the permissible concentration be reported. The commenter proposed permit the NRC to determine the extent limits in § 35.204(a). The NRC requires revising the rule text in § 35.3204(a) to of generator failures and take quicker this reporting because it is important clarify that the licensee would only action to protect patient safety. that the NRC and the distributors be report measurements of a Tc-99m Comment: Several Agreement States generator elution that exceeded the aware of such events in a timely disagree that the notification of the manner. The reporting requirement is regulatory limits at the time of generator discovery of an eluate exceeding the elution. not duplicative because the NRC does limits should be made to the NRC not require the distributor to report Response: The rule text was modified Operations Center. They recommended generator failures to the NRC.

based on this comment. The NRC agrees that a report be submitted to the NRC with the commenter that the proposed regional offices instead. The VI. Section-by-Section Analysis rule text in § 35.3204(a) and (b) was not commenters stated that any 30-day This section describes the specific clear and has amended it to clarify that notification to the Agreement States amendments by section for this final the reporting requirements only apply at must only be submitted to the NRC rule.

the time of generator elution. using the National Materials Events Comment: One commenter stated that Database (NMED), not the Operations Section 30.34 Terms and Conditions of the reporting and notification Center. One commenter stated that the Licenses requirement for failed Mo-99/Tc-99m doses received from most generators Paragraph(g). This paragraph adds a and Sr-82/Rb-82 generators was that exceed the eluate breakthrough new requirement for licensees to report increased from Compatibility Category C limits would not meet the reporting to the NRC when generator eluates to Compatibility Category B. The requirement for a diagnostic ME and exceed the permissible Mo-99 or Sr-82 commenter supports adding specific therefore does not meet the urgency for and Sr-85 concentration limits listed in reporting criteria for failed generators, reporting to the Operation Center. The § 35.204(a). Reporting must be in but wanted to retain the Compatibility commenter used the CardioGenR Sr/Rb accordance with the reporting and Category as C. generator recall as an example. Further, notification requirements in § 35.3204.

Response: No change was made to the the commenter stated that the current While the reporting requirement as well compatibility category for reporting and Integrated Materials Performance as the requirement to test every Mo-99 notification requirement for failed Mo- Evaluation Program requirement to elution is new, the testing by licensees 99/Tc-99m and Sr-82/Rb-82 generators report such events to the NMED is more of the first elution to ensure that it does based on this comment. In the proposed than sufficient. One commenter stated not exceed the permissible rule, the NRC designated the reporting that "[s]hould a trend of these events be concentration listed in § 35.204(a) and requirements in § 35.3204(a) and (b) as found, the Agreement States currently recording the results of these tests is Compatibility Category C. The final rule report these events to the Regional already required by this paragraph.

retains the same compatibility category Agreement State Officer." This change provides the information for reporting requirements in Response: No change was made to the to allow the NRC to assess a potential

§ 35.3204(a) and (b). rule text based on these comments. The situation quickly and efficiently when

33084 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations issues occur with generators that may listed as an Ophthalmic physicist on a amendment for medical use of cause unwarranted radiation exposure (1) specific medical use license issued byproduct material as described in to patients. This issue is discussed by the Commission or an Agreement § 35.1000.

further in Section III., Discussion, of this State; (2) permit issued by a Section 35.13 License Amendments document. Commission or Agreement State broad scope medical use licensee; (3) medical This section is amended by revising Section 32.72 Manufacture, paragraph (b), re-designating paragraphs use permit issued by a Commission Preparation,or Transferfor Commercial (d) through (g) as paragraphs (e) through master material licensee; or (4) permit Distribution of Radioactive Drugs (h), revising re-designated paragraphs issued by a Commission master material ContainingByproduct Materialfor (g) and (h), and adding new paragraphs licensee broad scope medical use Medical Use UnderPart 35 (d) and (i).

permittee. A written attestation will not Paragraph(a)(4). This paragraph is be required for this individual. Paragraph(b). This paragraph is amended to clarify that the applicant The definition for Preceptor is amended to allow a licensee to permit "commits to" rather than "satisfies" the an individual to work as an ophthalmic amended to add ARSO to the list of labeling requirements. Committing to individuals whose T&E is provided, physicist before applying for a license the prescriptive labeling requirements directed, or verified by a preceptor. This amendment, provided that the in the regulation in the license is a conforming change in support of the individual is already identified on a application would remove ambiguity new definition for Associate Radiation medical license or permit provided for related to what must appear on the Safety Officer. in § 35.13(b)(4).

label. Paragraph(d). This new paragraph Paragraph(b)(5)(i). This paragraph is Section 35.8 Information Collection requires a licensee to apply for and amended to remove the requirement to Requirements: OMB Approval receive a license amendment before obtain a written attestation for Paragraph(b). This paragraph is permitting an individual to work as an individuals seeking to be named as an amended to include § 35.3204 in the list ARSO or before the RSO assigns ANP and who are certified by a of sections in which the approved different tasks and duties to an ARSO specialty board whose certification information collection requirements are currently authorized on the license.

process has been recognized by the NRC contained. Paragraph(i). This new paragraph or an Agreement State to be an ANP. allows a licensee to receive sealed Section 35.12 Application for License, sources from a new manufacturer or a This is a conforming change in support Amendment, or Renewal new model number for a sealed source of the removal of the attestation requirement in § 35.55(a) of this chapter This section is amended to require listed in the SSDR used for manual for a board-certified ANP. only the submission of the original NRC brachytherapy for quantities and Paragraph(d). The existing Form 313, Application for Material isotopes already authorized by its requirements in paragraph (d) are re- License, or a letter containing license without first seeking a license designated as (e), and a new paragraph information required by NRC Form 313 amendment. This change provides (d) is added to clarify that the labeling when applying for a license, an manual brachytherapy licensees greater requirements that applicants commit to amendment, or renewal. This section flexibility in obtaining the sealed in paragraph (a) of this section are also clarifies what information should be sources necessary for patient treatments applicable to current licensees. submitted and adds a requirement to in a timely manner.

submit information on an individual Section 35.2 Definitions Section 35.14 Notifications seeking to be identified as an ARSO or New definitions for Associate as an ophthalmic physicist. Paragraph(a). The paragraph is Radiation Safety Officer and for Paragraph(b)(1). As part of the restructured to separate the notification Ophthalmicphysicist are added to this application for a medical use license, requirements for an individual who is section and the definition for Preceptor this paragraph is amended to require the certified by a board that is recognized by is amended. submittal of only the original NRC Form the NRC or an Agreement State from the The new definition for Associate 313. This change will relieve the burden requirements for an individual who is Radiation Safety Officer identifies the on the applicant by requiring less not certified by a board that is requirements an individual will need to paperwork to be submitted. It will also recognized by the NRC or an Agreement meet to be recognized as an ARSO. require the applicant to submit the T&E State but is listed on a license.

These requirements include that the qualifications for one or more ARSOs Additionally, the requirement to individual must meet the specified T&E and ophthalmic physicists that are to be provide a written attestation is removed criteria and that the individual be identified on the license. for an individual who is certified by a currently listed as an ARSO on a Paragraph(c). For license board that is recognized by the NRC or medical use license or permit for the amendments or renewals, this paragraph an Agreement State. Further discussion types of use of byproduct material for is amended to require the submittal of on removing the written attestation which the individual had been assigned only the original NRC Form 313 or a requirement can be found in Section III, tasks and duties by the RSO. Additional letter containing information required Discussion, of this document. Licensees information on ARSOs is located in by NRC Form 313. This change will may not permit an individual who is not Section III, Discussion, of this relieve the burden on the licensee by certified by a board that is recognized by document. requiring less paperwork to be the NRC or an Agreement State or does The new definition for Ophthalmic submitted. Additionally, it clarifies that not meet the requirements in § 35.13(b) physicist identifies the requirements an the letter submitted in lieu of NRC Form to work under their license without first individual will need to meet to be 313 must contain all the information obtaining an amendment to their recognized as an Ophthalmic physicist. required by NRC Form 313. license.

These requirements include that the Paragraph(d). This paragraph is Paragraph(a)(1). This paragraph is individual must meet the specified T&E amended and restructured to clarify restructured to more clearly identify the criteria in §§ 35.433(a)(2) and 35.59 and what information must be included in verification that a board-certified that the individual must be currently an application for a license or individual will need to provide along

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33085 with a copy of the individual's board Paragraph(b). This paragraph is treatment site, number of sources certification. This change does not modified to specify that a licensee's implanted, the total source strength impose any new requirements. management may appoint one or more implanted, and the date. The Paragraph(a)(2). This paragraph ARSOs. These appointed ARSOs must information required by the post-retains the notification requirements for be named on a medical license or permit implantation portion of the WD must be individuals who are authorized to work for the types of use of byproduct documented before the patient leaves under § 35.13(b) who are not certified by material for which the RSO, with the the post-treatment recovery area.

a board that is recognized by the NRC written agreement of the licensee's Paragraph(c). This paragraph is or an Agreement State but are listed on management, would assign tasks and restructured for clarity.

a license. The sentence in the proposed duties.

Section 35.41 Proceduresfor rule under § 35.14(a)(2), "The licensee The licensee's management is still limited to naming one RSO who will Administrations Requiring a Written shall only permit the individual to work remain responsible for implementing Directive with materials and uses previously authorized as an authorized user, an the entire radiation protection program. This section is amended by adding authorized medical physicist, The RSO is prohibited from delegating two new paragraphs with requirements ophthalmic physicist, or an authorized authority and responsibilities for that the licensee must address when nuclear pharmacist under § 35.13(b)" is implementing the radiation protection developing, implementing, and deleted in the final rule. The NRC is program. The proposed rule would have maintaining written procedures to removing this sentence because it is not required each ARSO to agree in writing provide high confidence that each necessary and the requirements are to the tasks and duties assigned by the administration requiring a WD is in already addressed in § 35.13(b). RSO. The NRC staff determined that this accordance with the WD.

Paragraph(b)(1). This paragraph is requirement is not necessary because Paragraph(b)(5). This new paragraph amended to require a licensee to notify the NRC holds the RSO responsible for requires that the licensee's procedures the Commission within 30 days after an implementing the radiation protection for any administration requiring a WD ARSO or ophthalmic physicist has a program. Therefore, the proposed include procedures for determining if an name change or discontinues requirement for each ARSO to agree in ME, as defined in § 35.3045 of this part, performance of his or her duties under writing to the tasks and duties assigned has occurred.

the license. by the RSO is not included in this final Paragraph(b)(6). This new paragraph Paragraph(b)(5). This paragraph is rule. requires the licensee to develop specific revised from the proposed rule Paragraph(c). An administrative procedures for permanent implant language. In the proposed rule, the change is made to this paragraph to brachytherapy programs. At a structure of § 35.14(b)(5) was changed remove the phrase "an AU or" because minimum, the procedures will include and this resulted in substantive changes it is redundant with "an individual determining post-implant source to the paragraph. The NRC did not qualified to be a Radiation Safety Officer position within 60 calendar days from intend to change the requirements in under §§ 35.50 and 35.59" in the same the date the implant was performed. If this paragraph. sentence. the licensee cannot make these Paragraph(b)(6). This new paragraph The position of an ARSO is discussed determinations within the 60 calendar requires a licensee to notify the NRC no further in Section III, Discussion, of this days because the patient is not later than 30 days after receiving a document. available, then the licensee must sealed source from a new manufacturer provide written justification that this Section 35.40 Written Directives or a new model number listed in the determination could not be made due to SSDR for manual brachytherapy for Paragraph(b). This paragraph is patient unavailability.

quantities and isotopes already restructured and amended to The determination that is required authorized by the license. accommodate specific requirements for includes the total source strength a WD for permanent implant administered outside of the treatment Section 35.15 Exemptions Regarding brachytherapy. Existing paragraph (b)(6) site compared to the total source Type A Specific Licenses of Broad is re-designated as paragraph (b)(7) and strength documented in the post-Scope a new paragraph (b)(6) is added to implantation portion of the WD.

This section is amended to make specify the information that must be A 60-calendar-day time frame ensures corresponding changes based on included in the pre-implantation (before that the licensee has ample time to make amendments to § 35.13 and to implantation) and post-implantation arrangements for the required

§ 35.14(b)(1). (after implantation) portions of the WD determinations. These determinations Paragraph(c). This paragraph is for permanent implant brachytherapy. are used to partially assess if an ME, as amended to update the reference from Paragraph(b)(6). This new paragraph defined in § 35.3045, has occurred.

§ 35.13(e) to § 35.13(f) as a result of provides details of the specific WD requirements for permanent implant Section 35.50 Trainingfor Radiation amendments to § 35.13. Safety Officer and Associate Radiation Paragraph(e). This paragraph is brachytherapy. Specifically, it clarifies that the WD is divided into two Safety Officer amended to include ophthalmic physicist as a result of amendments to portions, i.e., the pre-implantation Multiple changes are made to this

§ 35.14(b). portion and the post-implantation section. They include amending the title portion. The pre-implantation portion of of this section to add "and Associate Section 35.24 Authority and the WD requires documentation of the Radiation Safety Officer" because the Responsibilitiesfor the Radiation treatment site, the radionuclide, and the T&E requirements for this new position Protection Program total source strength. The information are also applicable to the ARSO. Other This section is amended to allow required by the pre-implantation changes are: (1) Removing the licensees to appoint qualified portion of the WD must be documented requirement to obtain a written individuals with expertise in certain prior to the start of the implantation. attestation for individuals qualified uses of byproduct material to be named The post-implantation portion of the under paragraph (a) of this section; (2) as ARSOs on a license or permit. WD requires the documentation of the adding a provision that will allow

33086 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations individuals identified as an AU, AMP, license permit provided that the AU, specialty board whose certification or ANP on a medical license to be an AMP, or ANP has experience with the process has been recognized under this RSO or an ARSO not only on that radiation safety aspects of similar types section by the Commission or an current license but also on a different of use of byproduct material. The Agreement State.

medical license; (3) adding a provision current regulations limit AUs, AMPs, Current regulations allow a medical to allow an individual to be named and ANPs to serve as an RSO only on physicist with any board certification in simultaneously both as the RSO and AU the license on which they are listed. diagnostic or therapeutic medical on a new license application; and (4) The AUs, AMPs, and ANPs must meet physics to serve as a supervising making certain administrative the same requirements to serve as the medical physicist in therapeutic clarifications. RSO regardless of which Commission procedures. The NRC believes that the Paragraph(a). The requirement for medical license they are identified on. supervision for therapeutic procedures individuals seeking to be named as an Therefore, not allowing them to serve as must be provided by a therapy medical RSO or ARSO to obtain a written an RSO on any Commission medical physicist who is certified in medical attestation is removed for those license is unnecessarily restrictive. This physics by a specialty board recognized individuals who are certified by a change will increase the number of under § 35.51 by the Commission or an specialty board whose certification individuals available to serve as RSOs Agreement State.

process has been recognized by the NRC and ARSOs on NRC medical licenses. Paragraph(b)(2). The wording in this or an Agreement State. Individuals Paragraph(c)(3). This new paragraph paragraph is revised to remove the seeking to be named as RSOs or ARSOs allows an individual who is not named requirement for a written attestation that via the certification pathway still need as an AU on a medical use license or is required in § 35.51(a). It is also to meet the training requirements in the permit, but is qualified to be an AU, to amended to incorporate the new new paragraph (d) of this section. be named simultaneously as the RSO language that the written attestation Further discussion on removing the and the AU on the same new medical must verify that the individual is able to written attestation requirement can be license. Current regulations, under independently fulfill the radiation found in Section III, Discussion, of this § 35.50(c)(2), do not permit an safety-related duties, rather than has document. individual who is not an AU on a achieved a level of competency to Paragraph(b)(1)(ii). This paragraph is license, but qualified to be an AU, to be function independently as an AMP.

amended to allow an ARSO, in addition an RSO. The individual must have the to the RSO, to provide supervised work Section 35.55 Trainingfor an experience with the radiation safety experience for individuals under the Authorized Nuclear Pharmacist aspects of the byproduct material for alternate pathway. The ARSO is limited which the authorization is sought. An Paragraph(a). The requirement for to providing supervised work individual may meet the qualifications individuals seeking to be named as an experience in those areas for which the of an AU via the board certification or ANP to obtain a written attestation is ARSO is authorized on a medical alternate pathway. An individual who removed for those individuals who are license or permit. uses the alternate pathway to be named certified by a specialty board whose Paragraph(b)(2). Reserved paragraph simultaneously as the RSO and the AU certification process has been (b)(2) is revised to include the on the same new medical use license recognized by the NRC or an Agreement requirements for an RSO or ARSO under must obtain a written attestation. State.

the alternate pathway to obtain a written The provision will provide flexibility Paragraph(b)(2). This paragraph is attestation signed by either an RSO or for an individual to serve as both an AU revised to conform to the removal of the ARSO. The language that is required in and as the RSO on a new medical use attestation requirement in paragraph (a) the written attestation is amended to license (a clinic or a medical institution) of this section. It is also amended to state that the individual "is able to and may help to make medical incorporate the new language that the independently fulfill the radiation procedures more widely available, written attestation must verify that the safety-related duties as an RSO or especially in rural areas. individual is able to independently ARSO," rather than that the individual Paragraph(d). This paragraph is fulfill the radiation safety-related duties, "has achieved a level of radiation safety amended to include ARSOs as rather than has achieved a level of knowledge to function independently" individuals who can provide supervised competency to function independently as an RSO or ARSO. training to an individual seeking as an ANP.

Paragraph(c)(1). This paragraph is recognition as an RSO or ARSO.

modified to allow medical physicists Section 35.57 Trainingfor who have been certified by a specialty Section 35.51 Trainingfor an Experienced Radiation Safety Officer, board whose process has been Authorized Medical Physicist Teletherapy or Medical Physicist, recognized by the Commission or an Paragraph(a). The requirement for Authorized Medical Physicist, Agreement State under § 35.51(a) to be individuals seeking to be named as an Authorized User, Nuclear Pharmacist, named as ARSOs. Additionally, the AMP to obtain a written attestation is and Authorized NuclearPharmacist requirement for a written attestation for removed for those individuals who are Multiple changes are made to this these medical physicists is removed. A certified by a specialty board whose section. Most of the changes are to the medical physicist seeking to be named certification process has been T&E requirements in response to the as an RSO or an ARSO still must meet recognized by the NRC or an Agreement requested amendments in PRM-35-20.

the training requirements in paragraph State. Further discussion on removing This includes recognizing the board (d) of this section. the written attestation requirement can certifications of individuals certified by Paragraph(c)(2). This paragraph is be found in Section III, Discussion, of boards recognized under subpart J, modified to allow AUs, AMPs, and this document. which was removed from 10 CFR part ANPs identified on a Commission or an Paragraph(a)(2)(i). This paragraph is 35 in a rulemaking dated March 30, Agreement State medical license or amended to clarify that an AMP who 2005 (70 FR 16336), and making permit to be an RSO or ARSO on any provides supervision for meeting the administrative clarifications. Additional Commission or an Agreement State requirements of this section must be information on PRM-35-20, as it relates license or Commission master material certified in medical physics by a to this rulemaking, is located in Section

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33087 II., Petition for Rulemaking, PRM 10 CFR part 35 for those materials and residency program director must 20, of this document. uses that the individual performed on or represent a residency training program Paragraph(a)(1). This paragraph is before January 14, 2019. approved by the Residency Review modified to add AMPs and ANPs. This Paragraph(b)(2). This paragraph is Committee of the Accreditation Council paragraph is also modified to restructured and expanded to recognize for Graduate Medical Education, the grandfather individuals listed in this a physician, dentist, or podiatrist who Royal College of Physicians and paragraph who were identified on a was certified by the named boards in the Surgeons of Canada, or the Council on license or permit on or before January now-removed subpart J of 10 CFR part Postdoctoral Training of the American 14, 2019. These individuals will not 35 on or before October 24, 2005. These Osteopathic Association. The residency need to comply with the applicable individuals do not need to comply with training program must include T&E training requirements of §§ 35.50, 35.51, the training requirements of subparts D specified in § 35.190.

or 35.55. through H of 10 CFR part 35 to be The residency program director who However, this paragraph is also identified as an AU on a Commission or provides written attestations does not modified such that RSOs and AMPs an Agreement State license or have to be an AU who meets the identified by this paragraph must meet Commission master material license requirements in §§ 35.57, 35.190, the training requirements in §§ 35.50(d) permit for those materials and uses that 35.290, or 35.390, or equivalent or 35.51(c), as appropriate, for any the individual performed on or before Agreement State requirements.

materials or uses for which they were October 24, 2005. However, the director must affirm in not authorized prior to the effective date writing that the attestation represents of this rule. This is not a new training Section 35.65 Authorization for the consensus of the residency program requirement. Current regulations require Calibration,Transmission,and faculty where at least one faculty individuals qualifying under §§ 35.50 Reference Sources member is an AU who meets the and 35.51 as RSOs and AMPs to meet This section is restructured and requirements in §§ 35.57, 35.190, the training requirements in §§ 35.50(e) amended to include three new 35.290, or 35.390, or equivalent and 35.51(c). paragraphs. Agreement State requirements, and that Paragraph(a)(2). This paragraph is Paragraph(b)(1). This new paragraph the AU concurs with the attestation.

amended to recognize individuals requires that medical use of any Additionally, the paragraph is certified by the named boards in the byproduct material in sealed sources amended to incorporate the new now-removed subpart J of 10 CFR part authorized by this section can only be language that the written attestation 35 on or before October 24, 2005. These used in accordance with the must verify that the physician is able to individuals do not need to comply with requirements in § 35.500. This is a independently fulfill the radiation the training requirements of § 35.50 to clarification that all of the specified safety-related duties, rather than has be identified as an RSO or as an ARSO byproduct material for medical use must achieved a level of competency to on a Commission or an Agreement State be under the supervision of an AU. function independently as an AU.

license or Commission master material Paragraph(b)(2). This new paragraph license permit for those materials and prohibits the bundling or aggregating of Section 35.204 Permissible uses that these individuals performed single-sealed sources to create a sealed Molybdenum-99, Strontium-82, and on or before October 24, 2005. source with an activity greater than Strontium-85 Concentrations Paragraph(a)(3). This paragraph is authorized by § 35.65. Paragraph(b). The current amended to recognize individuals Paragraph(c). This new paragraph requirement to measure the Mo-99 certified by the named boards in the clarifies that a licensee using concentration only after the first eluate now-removed subpart J of 10 CFR part calibration, transmission, and reference is changed to require that the Mo-99 35 on or before October 24, 2005. These sources in accordance with the concentration be measured after each individuals do not need to comply with requirements in paragraphs (a) or (b) of elution. A generator can be eluted the training requirements of § 35.51 to this section need not list these sources several times to obtain Tc-99m for be identified as an AMP on a on a specific medical use license. formulating radiopharmaceuticals for Commission or an Agreement State human use. Current regulations require Section 35.190 Trainingfor Uptake, license or Commission master material licensees to measure the Mo-99 Dilution, and Excretion Studies license permit for those materials and concentration only the first time a uses that these individuals performed Paragraph(a). For a physician seeking generator is eluted.

on or before October 24, 2005. These to be named as an AU of unsealed Paragraph(e). This new paragraph individuals are exempted from these byproduct material for uses authorized adds a requirement that licensees report training requirements only for those under § 35.100, the requirement to any measurement that exceeds the materials and uses these individuals obtain a written attestation is removed limits specified in § 35.204(a) for Mo-performed on or before October, 24, for an individual who is certified by a 99/Tc-99m and Sr-82/Rb-82 generators 2005. specialty board whose certification at the time of generator elution.

Paragraph(a)(4). This paragraph is process has been recognized by the NRC Further discussion on this issue can renumbered from current paragraph or an Agreement State. Further be found in Section III., Discussion, of (a)(3) and is not revised. discussion on removing the written this document.

Paragraph(b)(1). This paragraph is attestation requirement can be found in amended to change the date before Section III., Discussion, of this Section 35.290 Trainingfor Imaging which an individual is named on a document. and Localization Studies license as an AU to be on or before Paragraph(c)(2). This paragraph is Paragraph(a). For physicians seeking January 14, 2019. restructured and expanded to allow to be named as an AU of unsealed Additionally, this paragraph is certain residency program directors to byproduct material for uses authorized amended to clarify that an individual provide written attestations for a under § 35.200, the requirement to authorized on or before this date will physician seeking to be named as an AU obtain a written attestation is removed not be required to comply with the T&E of unsealed byproduct material for uses for those individuals who are certified requirements in subparts D through H of authorized under § 35.100. The by a specialty board whose certification

33088 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations process has been recognized by the NRC § 35.300 Use of Unsealed Byproduct provide written attestations for or an Agreement State. Further Materialfor Which a Written Directive Is physicians seeking to be named as AUs discussion on removing the written Required of unsealed byproduct material for uses attestation requirement can be found in The introductory paragraph is authorized under § 35.300. The Section III., Discussion, of this amended to clarify that a licensee may residency program director must document. only use unsealed byproduct material represent a residency training program Paragraph(c)(1)(ii). This paragraph is approved by the Residency Review identified in § 35.390(b)(1)(ii)(G) under amended to allow an ANP who meets Committee of the Accreditation Council this section. Currently, § 35.300 states the requirements in §§ 35.55 or 35.57 to for Graduate Medical Education or the that "A licensee may use any unsealed provide the supervised work experience Royal College of Physicians and byproduct material. This change specified in paragraph (c)(1)(ii)(G) of Surgeons of Canada or the Council on clarifies that a licensee's authorization this section for individuals seeking to be Postdoctoral Training of the American of the radiopharmaceuticals requiring a named as an AU of unsealed byproduct Osteopathic Association. The residency WD is only for those types of material for uses authorized under training program must include T&E radiopharmaceuticals for which the AU

§ 35.200. Paragraph (c)(1)(ii)(G) of this specified in § 35.300.

has documented T&E. An AU may be The residency program directors who section requires supervised work authorized for one or all of the specific experience in eluting generator systems. provide written attestations do not have categories described in to be AUs who meet the requirements in Many medical facilities no longer elute § 35.390(b)(1)(ii)(G), but not for all generators and instead receive unit §§ 35.57, 35.390, or equivalent unsealed byproduct material. Agreement State requirements, or have doses from centralized pharmacies; therefore, training on eluting generators Section 35.390 Trainingfor Use of experience in administering dosages in is not available at these facilities. Unsealed Byproduct Materialfor Which the same dosage category or categories Authorized Nuclear Pharmacists have a Written Directive Is Required as the individual requesting AU status.

the T&E to provide the supervised work However, they must affirm in writing Paragraph(a). For physicians seeking that the attestation represents the experience for AUs on the elution of to be named as AUs of unsealed generators. consensus of the residency program byproduct material for uses authorized faculty where at least one faculty Paragraph(c)(2). This paragraph is under § 35.300, the requirement to restructured and expanded to allow member is an AU who meets the obtain a written attestation is removed requirements in §§ 35.57, 35.390, or certain residency program directors to for those individuals who are certified equivalent Agreement State provide written attestations for by a specialty board whose certification requirements, has experience in individuals seeking to be named as an process has been recognized by the NRC administering dosages in the same AU of unsealed byproduct material for or an Agreement State. Further dosage category or categories as the uses authorized under §§ 35.100 and discussion on removing the written physician requesting AU status, and 35.200. The residency program director attestation requirement can be found in concurs with the attestation.

must represent a residency training Section III., Discussion, of this Additionally, this paragraph is program approved by the Residency document. amended to incorporate the new Review Committee of the Accreditation Paragraph(b)(1)(ii)(G)(3). This language that the written attestation Council for Graduate Medical paragraph is amended to identify a must verify that the physician is able to Education, the Royal College of single category of parenteral independently fulfill the radiation Physicians and Surgeons of Canada, or administrations of radionuclides in safety-related duties, rather than has the Council on Postdoctoral Training of which work experience is required for achieved a level of competency to the American Osteopathic Association. an individual seeking to be an AU for function independently as an AU.

The residency training program must uses under § 35.300.

include T&E specified in § 35.290. The current regulations include a Section 35.392 Trainingfor the Oral The residency program directors who broad category for parenteral Administration of Sodium Iodide 1-131 provide written attestations do not have administrations of "any other" Requiring a Written Directive in to be AUs who meet the requirements in radionuclide. This broad category is QuantitiesLess Than or Equal to 1.22

§§ 35.57, 35.290, or 35.390 and removed, as any new parenteral Gigabecquerels (33 Millicuries) 35.290(c)(1)(ii)(G), or equivalent administration of radionuclides not Paragraph(a). For physicians seeking Agreement State requirements. listed in this paragraph are regulated to be named as an AU for the oral However, they must affirm in writing under § 35.1000. This approach will administration of sodium iodide 1-131 that the attestation represents the allow the NRC to review each new requiring a WD in quantities less than consensus of the residency program proposed radionuclide for parenteral or equal to 1.22 gigabecquerels (33 faculty where at least one faculty administration and determine the millicuries), the requirement to obtain a member is an AU who meets the appropriate T&E for its use. written attestation is removed for those requirements in §§ 35.57, 35.290, or Current regulations require physicians individuals who are certified by a 35.390 and 35.290(c)(1)(ii)(G) or requesting AU status for administering specialty board whose certification equivalent Agreement State dosages of radioactive drugs to humans process has been recognized by the NRC requirements, and that the AU concurs (including parenteral administration) to or an Agreement State. Further with the attestation. have work experience with a minimum discussion on removing the written Additionally, the paragraph is of three cases in each category for which attestation requirement can be found in amended to incorporate the new they are requesting AU status. This Section IIl., Discussion, of this language that the written attestation requirement is retained in the final rule document.

must verify that the individual is able to with regard to all categories in this Paragraph(c)(3). This paragraph is independently fulfill the radiation paragraph. restructured and expanded to allow safety-related duties, rather than has Paragraph(b)(2). This paragraph is certain residency program directors to achieved a level of competency to restructured and expanded to allow provide written attestations for function independently as an AU. certain residency program directors to physicians seeking to be named as an

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33089 AU of unsealed byproduct material for physicians seeking to be named as an and (3). These paragraphs describe the the oral administration of sodium iodide AU of unsealed byproduct material for T&E required for physicians specified in 1-131 requiring a WD in quantities less the oral administration of sodium iodide § 35.396(a)(2) and (a)(3). The provisions than or equal to 1.22 gigabecquerels (33 1-131 requiring a WD in quantities within these paragraphs were the millicuries) authorized under § 35.300. greater than 1.22 gigabecquerels (33 previous paragraph (d) in the proposed The residency program director must millicuries) authorized under § 35.300. rule. Conforming changes are made to represent a residency training program The residency program director must support the new single category for approved by the Residency Review represent a residency training program parenteral administration in Committee of the Accreditation Council approved by the Residency Review § 35.390(b)(1)(ii)(G)(3).

for Graduate Medical Education or the Committee of the Accreditation Council Paragraph(b)(3). This paragraph is Royal College of Physicians and for Graduate Medical Education or the further restructured and expanded to Surgeons of Canada or the Council on Royal College of Physicians and allow certain residency program Postdoctoral Training of the American Surgeons of Canada or the Council on directors to provide written attestations Osteopathic Association. The residency Postdoctoral Training of the American for physicians seeking to be named as training program must include T&E Osteopathic Association. The residency an AU of unsealed byproduct material specified in § 35.392. training program must include T&E for the parenteral administration The residency program directors who specified in § 35.394. requiring a WD. The residency program provide written attestations do not have The residency program directors who director must represent a residency to be AUs who meet the requirements in provide written attestations do not have training program approved by the

§§ 35.57, 35.390, 35.392, 35.394, or to be AUs who meet the requirements in Residency Review Committee of the equivalent Agreement State §§ 35.57, 35.390, 35.394, or equivalent Accreditation Council for Graduate requirements, or have experience in Agreement State requirements, or have Medical Education or the Royal College administering dosages as specified in experience in administering dosages as of Physicians and Surgeons of Canada or

§ 35.390(b)(1)(ii)(G)(1) or specified in § 35.390(b)(1)(ii)(G)(2). the Council on Postdoctoral Training of 35.390(b)(1)(ii)(G)(2). However, they However, they must affirm in writing the American Osteopathic Association.

must affirm in writing that the that the attestation represents the The residency training program must attestation represents the consensus of consensus of the residency program include T&E specified in § 35.396.

the residency program faculty where at faculty where at least one faculty The residency program directors who least one faculty member is an AU who member is an AU who meets the provide written attestations do not have meets the requirements in §§ 35.57, requirements in §§ 35.57, 35.390, to be AUs who meet the requirements in 35.390, 35.392, 35.394, or equivalent 35.394, or equivalent Agreement State §§ 35.57, 35.390, 35.396, or equivalent Agreement State requirements, has requirements, has experience in Agreement State requirements, or have experience in administering dosages as administering dosages as specified in experience in administering dosages in specified in § 35.390(b)(1)(ii)(G)(1) or § 35.390(b)(1)(ii)(G)(2), and concurs the same category as the individual 35.390(b)(1)(ii)(G)(2), and concurs with with the attestation. requesting AU status. However, they the attestation. Additionally, the paragraph is must affirm in writing that the Additionally, this paragraph is amended to incorporate the new attestation represents the consensus of amended to incorporate the new language that the written attestation the residency program faculty where at language that the written attestation must verify that the physician is able to least one faculty member is an AU who must verify that the physician is able to independently fulfill the radiation meets the requirements in §§ 35.57, independently fulfill the radiation safety-related duties, rather than has 35.390, 35.396, or equivalent Agreement safety-related duties, rather than has achieved a level of competency to State requirements, and concurs with achieved a level of competency to function independently as an AU. the attestation. An AU who meets the function independently, as an AU. requirements in §§ 35.390, 35.396, or Section 35.396 Trainingfor the Section 35.394 Trainingfor the Oral equivalent Agreement State ParenteralAdministration of Unsealed Administration of Sodium Iodide 1-131 requirements, must have experience in Byproduct Material Requiring a Written Requiring a Written Directive in administering dosages in the same Directive Quantities Greater Than 1.22 category as the individual requesting Amendments to this section include AU user status.

Gigabecquerels (33 Millicuries) conforming changes to support the new Additionally, this paragraph is Paragraph(a). For physicians seeking single category for parenteral amended to incorporate the new to be named as an AU for the oral administration in language that the written attestation administration of sodium iodide 1-131 § 35.390(b)(1)(ii)(G)(3), changes to allow must verify that the physician is able to requiring a WD in quantities greater residency program directors to provide independently fulfill the radiation than 1.22 gigabecquerels (33 written attestations, and a change in the safety-related duties, rather than has millicuries), the requirement to obtain a attestation language. Additionally, this achieved a level of competency to written attestation is removed for those section is restructured and renumbered function independently as an AU.

individuals who are certified by a to accommodate the changes.

specialty board whose certification Paragraph(a). This paragraph was Section 35.400 Use of Sources for process has been recognized by the NRC restructured to list the physicians who Manual Brachytherapy or an Agreement State. Further can seek AU status under paragraphs This section is expanded to allow for discussion on removing the written (a)(1), (2), and (3) that were previously sources that are listed in the SSDR for attestation requirement can be found in listed as paragraphs (a), (b), and (c). manual brachytherapy to be used for Section III., Discussion, of this Conforming changes are made to other manual brachytherapy uses that document. support the new single category for are not explicitly listed in the SSDR.

Paragraph(c)(3). This paragraph is parenteral administration in Paragraph(a). This paragraph is restructured and expanded to allow § 35.390(b)(1)(ii)(G)(3). amended to allow sources that are listed certain residency program directors to Paragraph(b). This paragraph was in the SSDR for manual brachytherapy provide written attestations for restructured as paragraphs (b)(1), (2), medical uses to be used for manual

33090 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations brachytherapy medical uses that are not must modify its procedures required training program must include T&E explicitly listed in the SSDR provided under § 35.41 to specify the frequencies specified in § 35.400.

that these sources are used in at which the AMP or the ophthalmic The residency program directors who accordance with the radiation safety physicist will observe treatments, provide written attestations do not have conditions and limitations described in review the treatment methodology, to be AUs who meet the requirements in the SSDR. These radiation safety calculate treatment time for the §§ 35.57, 35.490, or equivalent conditions and limitations described in prescribed dose, and review records to Agreement State requirements.

the SSDR may apply to storage, verify that the treatment was However, they must affirm in writing handling, sterilization, conditions of administered in accordance with the that the attestation represents the use, or leak testing of radiation sources. WD. consensus of the residency program The NRC recognizes that the medical Paragraph(c). This paragraph is a faculty where at least one faculty uses specified in the SSDR may not be designation of the recordkeeping member is an AU who meets the all-inclusive. The final rule will permit requirements in the current regulation requirements in §§ 35.57, 35.490, or physicians to use manual brachytherapy under § 35.433(b). The requirements equivalent Agreement State sources to treat sites or diseases not have not changed. requirements, and concurs with the listed in the SSDR. For example, the attestation.

Section 35.490 Trainingfor Use of SSDR may specify that the sources are Additionally, the paragraph is Manual BrachytherapySources for interstitial uses, but the final rule amended to incorporate the new change allows the physician to use the Paragraph(a). For a physician seeking language that the written attestation sources for a topical use. The NRC has to be named as an AU of a manual brachytherapy source for the uses must verify that the physician is able to determined this flexibility should be authorized under § 35.400, the independently fulfill the radiation afforded to physicians to use their safety-related duties, rather than has discretion in the practice of medicine. requirement to obtain a written attestation is removed for an individual achieved a level of competency to Section 35.433 Strontium-90 Sources who is certified by a specialty board function independently as an AU.

for Ophthalmic Treatments whose certification process has been Section 35.491 Trainingfor This section title is modified by recognized by the NRC or an Agreement Ophthalmic Use of Strontium-90 deleting "Decay of" at the beginning of State. Further discussion on removing the title. This new title reflects the the written attestation requirement can Paragraph(b)(3). This paragraph is expanded information and requirements be found in Section III., Discussion, of amended to incorporate the new in this section. this document. language that the written attestation Paragraph(a). This paragraph is Paragraph(b)(1)(ii). This paragraph is must verify that the physician is able to amended and expanded to allow certain amended to require that the work independently fulfill the radiation individuals who are not AMPs to experience required by this section must safety-related duties, rather than has calculate the activity of strontium-90 be received at a medical facility achieved a level of competency to (Sr-90) sources that is used to determine authorized to use byproduct materials function independently as an AU.

the treatment times for ophthalmic under § 35.400 rather than at a medical Section 35.500 Use of Sealed Sources treatments. These individuals, defined institution. The current term "medical and Medical Devices for Diagnosis in § 35.2 as ophthalmic physicists, must institution" in this paragraph is defined meet the T&E requirements detailed in in § 35.2 as an organization in which This section is restructured and the new paragraph (a)(2) of this section more than one medical discipline is expanded to include the use of medical to perform the specified activities. A practiced. This definition unnecessarily devices to allow sealed sources and written attestation will not be required. limits where the work experience must medical devices that are listed in the These requirements are similar to the be obtained. Moreover, the fact that an SSDR for diagnostic medical uses to be T&E requirements for an AMP, but organization practices more than one used for diagnostic medical uses that are include only the requirements related to medical discipline does not ensure that not explicitly listed in the SSDR, and to brachytherapy programs. one of the medical disciplines is related allow sealed sources and medical Paragraph(b). This new paragraph to uses authorized under § 35.400. The devices to be used in research in establishes the tasks that individuals change will allow individuals to receive accordance with an active qualified under paragraph (a) of this work experience at a stand-alone, Investigational Device Exemption (IDE) section are required to perform in single-discipline clinic and ensure that application accepted by the FDA. This supporting ophthalmic treatments with the work experience is related to the section title is modified to add "and Sr-90. The first task is based upon the uses authorized under § 35.400. medical devices" because the use of requirements in § 35.432 for calculating Paragraph(b)(3). This paragraph is medical devices is added to this section.

the activity of each Sr-90 source used restructured and expanded to allow Paragraph(a). This paragraph is for ophthalmic treatments. This is not a certain residency program directors to amended to clarify that sealed sources new requirement, as it is required in the provide written attestations for that are not in medical devices for current regulation under § 35.433(a). physicians seeking to be named as an diagnostic medical uses and that are The second task is related to the AU of a manual brachytherapy source approved in the SSDR can be used for requirements in § 35.41 and is included for the uses authorized under § 35.400. other diagnostic medical uses that are in this final rule to ensure the safe use The residency program directors must not explicitly listed in an SSDR of Sr-90 for ophthalmic treatments. Both represent a residency training program provided that the sealed sources are the AMP and the ophthalmic physicist approved by the Residency Review used in accordance with radiation safety are required to assist the licensee in Committee of the Accreditation Council conditions and limitations described in developing, implementing, and for Graduate Medical Education or the the SSDR. These radiation safety maintaining written procedures to Royal College of Physicians and conditions and limitations described in provide high confidence that the dose Surgeons of Canada or the Council on the SSDR may include storage, administration is in accordance with the Postdoctoral Training of the American handling, sterilization, conditions of WD. Under this paragraph, the licensee Osteopathic Association. The residency use, or leak testing of radiation sources.

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33091 Paragraph(b). This paragraph is have been anticipated when the devices Paragraph(d)(2). This paragraph is added to allow medical devices were registered. restructured and amended to clarify that containing sealed sources to be used for Paragraph(a). This paragraph the training required by this paragraph diagnostic medical uses that are not requires that a licensee use only sealed on the operation and safety of the unit explicitly listed in an SSDR if both the sources approved in the SSDR for applies to any new staff who will sealed sources and the medical devices therapeutic medical uses in photon- operate the unit or units at the facility.

are approved in the SSDR for diagnostic emitting remote afterloader units, This requirement is added to enhance medical uses and provided that the teletherapy units, or gamma stereotactic the safety of patients by eliminating medical devices are used in accordance radiosurgery units as provided for in the potential delay in training of new staff with radiation safety conditions and SSDR or for research in accordance with until the required annual training, limitations described in the SSDR. an active IDE application accepted by which could lead to undertrained These radiation safety conditions and the FDA, provided the requirements of individuals operating the unit.

limitations described in the SSDR may § 35.49(a) are met. Paragraph(g). This paragraph is include storage, handling, sterilization, Paragraph(b). This paragraph amended to conform with the conditions of use, and leak testing of continues to require that a licensee only restructuring of paragraph (d)(2) of this radiation sources. use photon emitting remote afterloader section.

Paragraph(c). This new paragraph units, teletherapy units, or gamma stereotactic radiosurgery units approved Section 35.655 Full-Inspection allows sealed sources and devices for in the SSDR or for research in Servicingfor Teletherapy and Gamma diagnostic medical uses to be used in accordance with an active IDE StereotacticRadiosurgery Units research in accordance with an active IDE application accepted by the FDA, application accepted by the FDA This section title is modified to delete provided the requirements of § 35.49(a) provided the requirements of § 35.49(a) "5-year inspection" and insert "Full-are met. are met. However, this paragraph is inspection servicing" to more accurately amended to provide that these units reflect the requirements in this section Section 35.590 Trainingfor Use of may be used for medical uses that are for inspection and servicing of Sealed Sources and Medical Devices for not explicitly provided for in the SSDR, teletherapy units and gamma Diagnosis provided that these units are used in stereotactic radiosurgery units.

This section is restructured and accordance with the radiation safety Paragraph(a). This paragraph is expanded to clarify that both diagnostic conditions and limitations described in amended to extend the full inspection sealed sources and devices authorized the SSDR. and servicing interval between each full in § 35.500 are included in the T&E inspection servicing for gamma Section 35.610 Safety Proceduresand stereotactic radiosurgery units from 5 requirements of this section.

Instructionsfor Remote Afterloader years to 7 years to assure proper Paragraph(a). This paragraph is Units, Teletherapy Units, and Gamma functioning of the source exposure revised to reference the redesignated Stereotactic RadiosurgeryUnits mechanism. The interval between each paragraphs (c) and (d).

Paragraph(b). This new paragraph Paragraph(d)(1). This paragraph is full inspection and servicing of recognizes the individuals who are amended and restructured to add a new teletherapy units remains the same (not authorized for uses listed in § 35.200, or training requirement for the use of to exceed 5 years). For gamma equivalent Agreement State remote afterloader units, teletherapy stereotactic radiosurgery units, the full requirements, for use of diagnostic units, and gamma stereotactic inspection and servicing to assure sealed sources or devices authorized radiosurgery units. This amendment proper functioning of the source under § 35.500. requires all individuals who operate exposure mechanism is performed when these units to receive vendor the sources are taken out of the unit and Section 35.600 Use of a Sealed Source operational and safety training prior to before the new sources are placed in the in a Remote Afterloader Unit, the first use for patient treatment of a unit (source replacement). Because the Teletherapy Unit, or Gamma new unit or an existing unit with a cost to replace the decaying sources in StereotacticRadiosurgery Unit manufacturer upgrade that affects the a gamma stereotactic radiosurgery unit This section is amended to separate operation and safety of the unit. This can be significant, licensees have the uses of photon-emitting remote training must be provided by the device requested that the intervals between afterloader units, teletherapy units, or manufacturer or by an individual each full inspection servicing for these gamma stereotactic radiosurgery units certified by the device manufacturer to units be extended beyond 5 years. In from the uses of the sealed sources provide the training. This training is support of this extension, the NRC finds contained within these units. The also required when software upgrades that the 6-month routine preventive amended section allows only sealed are made by the vendor or the maintenance that is performed on these sources approved in the SSDR in manufacturer that affect the operation units is adequate to ensure the proper devices to deliver therapeutic medical and safety of the unit. functioning of the source exposure treatments as provided for in the SSDR. Currently, § 35.610(d) requires that all mechanisms and, therefore, this final However, the units containing these individuals who operate these units be rule extends the full inspection and sources can be used for therapeutic provided safety instructions initially, servicing interval for gamma stereotactic medical treatments that are not and at least annually; however, there is radiosurgery units from 5 years to 7 explicitly provided for in the SSDR, no requirement for these individuals to years.

provided that they are used in receive instructions when the unit is Additionally, this paragraph requires accordance with radiation safety upgraded. The amendment requires that the full inspection and servicing of conditions and limitations described in individuals who operate these new or these units be performed during each the SSDR. The purpose of this upgraded units to receive training prior source replacement regardless of the last amendment is to allow physicians to first use for patient treatment. These time the units were inspected and flexibility to exercise their medical individuals include AUs, AMPs, serviced.

judgment and to use these devices for operators, and others that need to know The full inspection and servicing new therapeutic treatments that may not how the units operate. interval of a teletherapy unit has not

33092 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations been extended from the current interval training program must include T&E an ME for other administrations. The of 5 years. The current interval of 5 specified in § 35.690. paragraph retains the current years helps prevent potentially serious The residency program directors who introductory sentence, "A licensee shall radiation exposure of teletherapy provide written attestations do not have report any event as a medical event, operators and patients in the event that to be AUs who meet the requirements in except for an event that results from the source exposure mechanism fails. §§ 35.57, 35.690, or equivalent patient intervention..." The The radioactive source contained in a Agreement State requirements, for the introductory sentence of § 35.3045(a),

teletherapy unit produces radiation type(s) of therapeutic medical unit(s) for published in the proposed rule in July fields on the order of hundreds of rads which the individual is requesting AU 21, 2014, provided that "A licensee per minute in areas accessible to status. However, they must affirm in shall report as a medical event, any patients and operators. In the event of writing that the attestation represents administration requiring a written a source exposure mechanism failure, the consensus of the residency program directive, except for an event that the exposed source could result in faculty where at least one faculty results from patient intervention.

overexposure of a patient or operating member is an AU who meets the The phrase "requiring a written personnel in a short period of time. requirements in §§ 35.57, 35.690, or directive" is removed from this sentence equivalent Agreement State in the final rule. This revision in the Section 35.690 Trainingfor Use of requirements, for the type(s) of final rule maintains the current Remote After]oader Units, Teletherapy therapeutic medical unit(s) for which requirement that all events that meet the Units, and Gamma Stereotactic the individual is requesting AU status ME criteria be reported, not just those Radiosurgery Units and concurs with the attestation. that require a WD.

Paragraph(a). For a physician seeking Additionally, this paragraph is Paragraph(a)(1). This new paragraph to be named as an AU for sealed sources amended to incorporate the new contains criteria for reporting an ME for for uses authorized under § 35.600, the language that the written attestation all administrations other than requirement to obtain a written must verify that the physician is able to permanent implant brachytherapy attestation is removed for an individual independently fulfill the radiation administrations. Criteria for reporting an who is certified by a specialty board safety-related duties, rather than has ME involving permanent implant whose certification process has been achieved a level of competency to brachytherapy are in the new paragraph recognized by the NRC or an Agreement function independently as an AU. (a)(2) in this section. The criteria used State. Further discussion on removing to determine if an ME has occurred for the written attestation requirement can Section 35.2024 Records of Authority all administrations, except permanent be found in Section III., Discussion, of and Responsibilitiesfor Radiation implant brachytherapy, are unchanged this document. Protection Programs except (1) the current paragraph (a)(3)

Paragraph(b)(1)(ii). This paragraph is Paragraph(c). This new paragraph related to the dose to the skin or an amended to require that the work requires the licensee to keep records of organ or tissue other than the treatment experience required by this section be each ARSO assigned under § 35.24(b) site is restructured for clarity as the new received at a medical facility authorized for 5 years after the ARSO is removed paragraph (a)(1)(iii); and (2) a criterion to use byproduct materials under from the license. This record must is added in the new paragraph

§ 35.600 rather than at a medical include the written document (a)(1)(ii)(A) of this section for reporting institution. The current term "medical appointing the ARSO signed by the an administration involving the wrong institution" in this paragraph is defined licensee's management. radionuclide for a brachytherapy in § 35.2 as an organization in which procedure as an ME.

more than one medical discipline is Section 35.2310 Records of Safety Paragraph(a)(2). This new paragraph practiced. This definition unnecessarily Instruction is added to establish separate criteria for limits where the work experience must This section is amended to conform to reporting MEs involving permanent be obtained. Moreover, the fact that an the changes made in § 35.610 by adding implant brachytherapy. These new organization practices more than one a requirement to maintain the criteria are designed to ensure reporting medical discipline does not ensure that operational and safety instructions of situations where harm or potential one of the medical disciplines is related required by § 35.610. harm to the patient may occur. The new to uses authorized under § 35.600. The criteria for reporting an ME involving change allows the work experience to be Section 35.2655 Records of Full- permanent implant brachytherapy are:

received at a stand-alone single Inspection Servicingfor Teletherapy (1) The total source strength discipline clinic for the uses authorized and Gamma Stereotactic Radiosurgery administered differs by 20 percent or under § 35.600. Units more from the total source strength Paragraph(b)(3). This paragraph is This section title is modified to delete documented in the post-implantation restructured and expanded to allow "5-year inspection" and insert "full- portion of the WD. An example of a certain residency program directors to inspection servicing" to reflect the situation that meets this criterion is a provide written attestations for changes to § 35.655 requiring full situation in which the sealed sources physicians seeking to be named as an inspection and servicing of teletherapy that were implanted had a different AU for sealed sources for uses units and gamma stereotactic source strength than what was intended.

authorized under § 35.600. The radiosurgery units. This situation could occur because the residency program directors must licensee ordered, or the vendor shipped, represent a residency training program Section 35.3045 Report and sealed sources with the wrong activity; approved by the Residency Review Notification of a Medical Event (2) The total source strength Committee of the Accreditation Council Paragraph(a). This paragraph is administered outside of the treatment for Graduate Medical Education, the restructured and amended to provide site exceeds 20 percent of the total Royal College of Physicians and separate specific criteria for reporting an source strength documented in the post-Surgeons of Canada, or the Council on ME involving permanent implant implantation portion of the WD. An Postdoctoral Training of the American brachytherapy. These new criteria are example of a situation that meets this Osteopathic Association. The residency different from the criteria for reporting criterion is a situation in which the

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33093 sealed sources are unintentionally administered to patients or human a backfitting provision. Therefore, a implanted outside of the treatment site. research subjects; when the distributor backfitting analysis is not required.

This situation would be identified by was notified; and the action taken.

the licensee when determinations are X. Cumulative Effects of Regulation Paragraph(b). This new paragraph made pursuant to § 35.41; requires a licensee to submit a written Cumulative effects of regulation (CER)

(3) An administration that includes report to the appropriate NRC Regional describes the challenges that licensees, the wrong radionuclide; the wrong Office listed in § 30.6 within 30 certificate holders, States, or other individual or human research subject; calendar days after discovery of an entities may encounter while sealed source, or sources, implanted eluate exceeding the permissible implementing new regulatory directly into a location discontiguous concentration at the time of generator requirements (e.g., rules, generic letters, from the treatment site, as documented elution. The report must be submitted orders, inspection findings). The CER is in the post-implantation portion of the by an appropriate method listed in WD; or a leaking sealed source resulting an organizational effectiveness

§ 30.6(a). The report must include the challenge that results from a licensee or in a dose that exceeds 0.5 Sv (50 rem) action taken by the licensee; patient to an organ or tissue. Only the criteria impacted entity implementing a dose assessments; the methodology used significant number of new and complex for a leaking sealed source retains the in making the patient dose assessment dose threshold in current regulations regulatory actions stemming from if the eluate was administered to multiple regulatory actions, within a because the NRC determined the leaking patients or human research subjects; sealed source delivering a dose below limited implementation period and with probable cause and assessment of failure available resources (which may include this threshold does not need to be in the licensee's equipment; procedures reported as an ME. Several situations limited available expertise to address a or training that contributed to the specific issue). The CER can potentially that will meet this criterion are self- excessive readings if an error occurred evident, i.e., the wrong patient, the distract licensee or entity staff from in the licensee's breakthrough executing other primary duties that wrong treatment site, or a leaking sealed determination; and the information in ensure safety or security. The NRC source. Three criteria published in the the telephone report as required by proposed rule on July 21, 2014, have specifically requested comments on the paragraph (a) of this section. cumulative effects of this rulemaking in been deleted in the final rule: (1) The criterion related to absorbed dose to the VII. Regulatory Flexibility Certification the proposed rule published on July 21, maximally exposed 5 contiguous cubic 2014, and received three comments on Under the Regulatory Flexibility Act the CER. Two Agreement States stated centimeters of normal tissue located (5 U.S.C. 605(b)), the NRC certifies that that with steady accretion of outside the treatment site; (2) the this rule will not, if promulgated, have regulations, there are always criterion related to absorbed dose to the a significant economic impact on a unintended consequences, in that the maximally exposed 5 contiguous cubic centimeters of normal tissue located substantial number of small entities. additional costs impact decisions on This final rule affects a number of within the treatment site; and (3) the "small entities" as defined by the functions of the State radiation control criterion related to an error of 20 program. With regard to the NRC's cost/

percent or more in calculating the total Regulatory Flexibility Act or the size benefit analysis in the draft Regulatory source strength. These deletions are standards established by the NRC Analysis, these commenters stated that based on the comments received on the (§2.810). However, as indicated in the the NRC's cost/benefit analysis proposed rule and is discussed in regulatory analysis available as appeared to support the rule. One of the Section V., Public Comment Analysis, of indicated in Section XXIII, "Availability commenters expressed concern that this document. of Documents" section of this there is the potential for applying rules document, these amendments do not Section 35.3204 Report and in a manner in which they were not have a significant economic impact on Notification for an Eluate Exceeding intended based on the permanent the affected small entities. The NRC PermissibleMolybdenum-99, Strontium- requested comment on the proposed implant brachytherapy language in 82, and Strontium-85 Concentrations rule and accompanying draft regulatory

§ 35.40(b)(6). The commenter was concerned about the specification of This new section requires reporting analysis on the impact of the proposed rule on small entities. The NRC received dose to the normal tissues, located and notification of an elution from a within the treatment site, in the Mo-99/Tc-99m or Sr-82/Rb-82 generator no comment submissions from an proposed rule in § 35.40(b)(6)(i). Based that exceeds the regulatory requirements identified small entity.

on these comments and other public in §§ 30.34 and 35.204(a). Further VIII. Regulatory Analysis comments, § 35.40(b)(6)(i) in the final discussion of this requirement can be The NRC has prepared a final rule does not require the AU to specify found in Section III., Discussion, of this regulatory analysis on this regulation. dose to the normal tissues located document.

Paragraph(a). This new paragraph The regulatory analysis examines the within the treatment site. The comments costs and benefits of the alternatives are discussed in Section V., Public requires a licensee to notify both the NRC Operations Center and the considered by the NRC. The regulatory Comment Analysis, of this document.

distributor, which also may sometimes analysis is available as indicated in XI. Plain Writing be the manufacturer, of the generator by Section XXIII., Availability of telephone within 7 calendar days after Documents, of this document. The Plain Writing Act of 2010 (Pub.

discovery that an eluate exceeds the L. 111-274) requires Federal agencies to IX. Backfitting and Issue Finality permissible concentration listed in write documents in a clear, concise, and

§ 35.204(a). This notification must The backfit rule and issue finality well-organized manner. The NRC has include the manufacturer, model provisions of 10 CFR part 52 (which are written this document to be consistent number, and serial number (or lot found in the regulations at §§ 50.109, with the Plain Writing Act as well as the number) of the generator; the results of 70.76, 72.62, 76.76, and in 10 CFR part Presidential Memorandum, "Plain the measurement; the date of the 52) do not apply to this final rule. Parts Language in Government Writing,"

measurement; whether dosages were 30, 32, and 35 of 10 CFR do not contain published June 10, 1998 (63 FR 31883).

33094 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations XII. Environmental Impact: Categorical inspection interval for a gamma required to obtain or retain a benefit. All Exclusion stereotactic radiosurgery unit from 5 other information collection The NRC has determined that the years to 7 years. The amendments are requirements in this final rule are following actions in this final rule are procedural in nature. It is expected that mandatory. Section 161b of the AEA the types of actions described in this rule will not cause any significant authorizes the NRC to impose these categorical exclusions in § 51.22(c)(2) increase in radiation exposure to the information collections.

public or radiation release to the You may submit comments on any and (c)(3)(i-v):

(1) The amendments to the general environment beyond the exposures or aspect of the information collection(s),

administrative requirements and general releases currently resulting from the including suggestions for reducing the medical use of byproduct material. burden, by the following methods:

technical requirements meet the The NRC requested the views of the

• Federalrulemaking Website: Go to categorical exclusion criteria under States and State Liaison Officers on the http://www.regulations.govand search

§ 51.22(c)(2). environmental assessment for this rule. for Docket ID NRC-2008-0175.

(2) The amendments to sealed sources The NRC did not receive any comments

• Mail comments to: FOIA, Privacy, usage provide clarifications to the on the environmental assessment from and Information Collections Branch, current regulations and meet the the States or State Liaison Officers. Office of Information Services, Mail categorical exclusion criteria under The determination of the Stop: T-5 F53, U.S. Nuclear Regulatory

§ 51.22(c)(2). environmental assessment is that this Commission, Washington, DC 20555-(3) The amendments to the rule would have no significant impact 0001 or to Matthew Oreska, Desk requirements for reporting MEs and on the quality of the human Officer, Office of Information and reporting failed generator tests meet the environment. The environmental Regulatory Affairs (3150-0010), NEOB-categorical exclusion criteria under assessment is available as indicated in 10202, Office of Management and

§ 51.22(c)(3)(iii). Section XXIII, Availability of Budget, Washington, DC 20503; (4) The amendments related to the Documents, of this document. telephone: 202-395-9593, email: oira record-keeping requirements meet the XIV. Paperwork Reduction Act submission@omb.eop.gov.

categorical exclusion criteria under

§ 51.22(c)(3)(ii). Statement Public Protection Notification (5) The amendments related to the This final rule contains new or The NRC may not conduct or sponsor, T&E requirements meet the categorical amended collections of information and a person is not required to respond exclusion criteria under subject to the Paperwork Reduction Act to, a request for information or an

§ 51.22(c)(3)(iv). of 1995 (44 U.S.C. 3501 et seq.). The information collection requirement There are two amendments that do collections of information were unless the requesting document not meet the categorical exclusion approved by the Office of Management displays a currently valid OMB control criteria in § 51.22. Therefore, an and Budget, control number 3150-0010. number.

environmental assessment has been The burden to the public for the prepared for this rule for the two information collection(s) is estimated to XV. Congressional Review Act amendments that do not meet the average 2.52 hours6.018519e-4 days <br />0.0144 hours <br />8.597884e-5 weeks <br />1.9786e-5 months <br /> per response, This final rule is a rule as defined in categorical exclusion criteria in § 51.22. including the time for reviewing the Congressional Review Act (5. U.S.C.

The environmental assessment is instructions, searching existing data 801-808). However, the Office of discussed in Section XIII., sources, gathering and maintaining the Management and Budget has not found Environmental Assessment and Final data needed, and completing and it to be a major rule as defined in the Finding of No Significant reviewing the information collection. Congressional Review Act.

Environmental Impact, of this The information collection is being document. The amendments that do not conducted to provide the NRC the XVI. Criminal Penalties meet the categorical exclusions in information it needs to effectively For the purpose of Section 223 of the

§ 51.22 are: (1) The increase in the evaluate license applications, Atomic Energy Act of 1954, as amended frequency of Mo-99 measurement tests applications for amendments, licensee (AEA), the NRC is issuing this final rule required in § 35.204, and (2) the operations, and significant safety events that amends 10 CFR parts 30, 32, and 35 increase in the full inspection time for protection of public health and under one or more of Sections 161b, interval for a gamma stereotactic safety. The information will be used by 161i, or 161o of the AEA. Willful radiosurgery unit from 5 years to 7 years the NRC in evaluating compliance with violations of the rule will be subject to in § 35.655. licensing requirements. The NRC will criminal enforcement.

assess the adequacy of an applicant's or XIII. Environmental Assessment and licensee's physical location, equipment, XVII. Coordination With NRC Final Finding of No Significant organization, training, experience, Agreement States Environmental Impact procedures and plans for protection of The NRC has coordinated with the The Commission has determined public health and safety. The NRC Agreement States throughout the under the National Environmental review and the findings derived there development of this final rule.

Policy Act of 1969, as amended, and the form the basis of NRC licensing and Agreement State representatives have NRC's regulations in Subpart A of 10 inspection decisions. The NRC uses served on the rulemaking working group CFR part 51, that this rule, if adopted, reports of significant safety events in that developed the proposed and final would not be a major Federal action evaluating the protective actions amendments to 10 CFR part 35 and on significantly affecting the quality of the required to avoid exposures to patients the steering committee for the human environment and; therefore, an and the public that could exceed rulemaking.

environmental impact statement is not regulatory limits, and therefore impact Through an All Agreement State required. The amendments that were the public health and safety and the Letter (FSME-11-044, dated May 20, subject of the Environmental environment. Responses to the 2011), the Agreement States were Assessment establish more frequent information collection requirements at notified of the availability of measuring of Mo-99 and increase the §§ 32.72 and 35.12 are mandatory or are preliminary rule text for comments

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33095 posted on www.regulations.gov and XVIII. Agreement State Compatibility orderly pattern in the regulation of noticed in the Federal Register (76 FR Under the "Policy Statement on agreement material on a national basis.

29171; May 20, 2011). The Federal Adequacy and Compatibility of An Agreement State should adopt the Register notice also invited the Agreement State Programs" approved by essential objectives of the Category C Agreement States to participate at the the Commission on June 30, 1997, and program elements. Compatibility two public workshops that were held in published in the Federal Register on Category D are those program elements New York City, New York, and Houston, September 3, 1997 (62 FR 46517), NRC that do not meet any of the criteria of Texas, during the summer of 2011. program elements (including Category A, B, or C, and, therefore do In February 2013, the NRC provided regulations) are placed into not need to be adopted by Agreement the preliminary draft proposed rule to Compatibility Categories A, B, C, D, States for purposes of compatibility.

the Agreement States for a 30-day NRC, or adequacy category Health and Compatibility Category NRC are those review. The Agreement States provided Safety (H&S). Compatibility Category A program elements that address areas of comments on the preliminary draft are those program elements that are regulation that cannot be relinquished proposed rule. Several comments basic radiation protection standards and to the Agreement States under the AEA resulted in revisions to the discussion scientific terms and definitions that are or NRC rules. These program elements section of the proposed rule to provide necessary to understand radiation should not be adopted by the Agreement additional emphasis or clarity. A protection concepts. An Agreement States. Adequacy Category H&S are summary of the Agreement States State should adopt Category A program program elements that are required elements in an essentially identical because of a particular health and safety comments and the NRC staff responses manner in order to provide uniformity role in the regulation of agreement to the comments is contained in in the regulation of agreement material material within the State and should be to SECY-13-0084.

on a nationwide basis. Compatibility adopted in a manner that embodies the Through an All Agreement State Category B are those program elements Letter (FSME-14-078, dated August 15, essential objectives of the NRC program.

that apply to activities that have direct 2014), the Agreement States were and significant effects in multiple The final rule is a matter of notified of the availability of the jurisdictions. An Agreement State compatibility between the NRC and the proposed rule noticed in the Federal should adopt Category B program Agreement States, thereby providing Register (79 FR 42410; July 21, 2014). elements in an essentially identical consistency among Agreement State and The Agreement States also had an manner. Compatibility Category C are NRC requirements. Discussion on the opportunity to comment on the draft those program elements that do not Compatibility Category for § 35.3045, final rule. In preparing both the meet the criteria of Category A or B, but Report and notification of a medical proposed rule and the final rule, the the essential objectives of which an event, can be found in Section V.,

rulemaking working group considered Agreement State should adopt to avoid Public Comment Analysis, of this the comments provided by the conflict, duplication, gaps, or other document. The compatibility categories Agreement States. conditions that would jeopardize an are designated in the following table:

COMPATIBILITY TABLE Compatibility Section Change Subject Existing New Part 30 30.34(g) .............................. A m end ................................ Term s and conditions of licenses .......................................... B B Part 32 32.72(a)(4) .......................... Amend ................................ Manufacture, preparation, or transfer for commercial dis- B B tribution of radioactive drugs containing byproduct mate-rial for medical use under 10 CFR part 35.

32.72(b)(5)(i) ....................... Amend ................................ Manufacture, preparation, or transfer for commercial dis- B B tribution of radioactive drugs containing byproduct mate-rial for medical use under 10 CFR part 35.

32.72(d) .............................. New .................................... Manufacture, preparation, or transfer for commercial dis- B tribution of radioactive drugs containing byproduct mate-rial for medical use under 10 CFR part 35.

Part 35 35 .2 ..................................... New .................................... Definitions-Associate Radiation Safety Officer ...................

35 .2 ..................................... New .................................... Definitions-Ophthalmic physicist .........................................

35 .2 ..................................... Amend ................................ Definitions- P receptor ........................................................... D 35 .12 (b)(1) .......................... Amend ................................ Application for license, amendment, or renewal ................... D 35 .12 (c)(1) .......................... Amend ................................ Application for license, amendment, or renewal ................... D D

35.12(c)(1 )(ii) ...................... Amend ................................ Application for license, amendment, or renewal ................... D 35 .12 (d ) .............................. Amend ................................ Application for license, amendment, or renewal ...................

35 .12 (d )(1) .......................... New .................................... Application for license, amendment, or renewal ...................

35.12(d)(2) .......................... New .................................... Application for license, amendment, or renewal ...................

35.12(d)(3) .......................... New .................................... Application for license, amendment, or renewal ................... D 35.12(d)(4) .......................... Amend ................................ Application for license, amendment, or renewal ................... D 35 .13 (b ) .............................. Amend ................................ License am endm ents ............................................................

33096 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations COMPATIBILITY TABLE-Continued Compatibility Section Change Subject Existing New 35 .13 (d ) .............................. New ....................................

License amendments ............................................................

35 .13 (i) ................................ New ....................................

License amendments ............................................................

35 .14 (a ) .............................. Amend ................................ Notificatio n s ........................................................................... 0 35.14(b)(1) .......................... Amend ................................ Notificatio n s ........................................................................... 0 D

35.14(b)(2) .......................... Amend ................................ Notificatio n s ...........................................................................

35.14(b)(6) .......................... New ....................................

Notificatio n s ........................................................................... D 35.15(c) and (e) .................. Amend ................................ Exemptions regarding Type A specific licenses of broad scope.

35.24(b) .............................. Amend ................................ Authority and responsibilities for the radiation protection H&S program. D 35.24(c) ............................... Amend ................................ Authority and responsibilities for the radiation protection program. H&S 35.40(b)(6) .......................... Amend ................................ W ritte n d irectiv e s ................................................................... H&S 35.40(b)(7) .......................... Amend Redesignated ......... W ritte n d irectiv e s ...................................................................

35.41 (b)(5) .......................... New ....................................

Procedures for administrations requiring a written directive 35.41 (b)(6) .......................... New ....................................

Procedures for administrations requiring a written directive 35 .5 0 ................................... Amend ................................ Training for Radiation Safety Officer and Associate Radi- B ation Safety Officer. B 35 .5 0 (a ) .............................. Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer. B 35.50(a)(2)(ii)(B) ................. Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer. B 35.50(b)(1)(ii) ...................... Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer.

35.50(b)(2) .......................... Training for Radiation Safety Officer and Associate Radi-New ....................................

ation Safety Officer.

35.50(c)(1) .......................... Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer.

35.50(c)(2) .......................... Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer.

35.50(c)(3) .......................... New ....................................

Training for Radiation Safety Officer and Associate Radi-ation Safety Officer.

35 .5 0 (d ) .............................. Amend ................................ Training for Radiation Safety Officer and Associate Radi-ation Safety Officer.

35 .5 1(a ) .............................. Amend ................................ Training for an authorized medical physicist .........................

35.51 (a)(2)(i) ....................... Amend ................................ Training for an authorized medical physicist .........................

35.51 (b)(2) .......................... Amend ................................ Training for an authorized medical physicist .........................

35 .5 5 (a ) .............................. Amend ................................ Training for an authorized nuclear pharmacist .....................

35.55(b)(2) .......................... Amend ................................ Training for an authorized nuclear pharmacist .....................

35.57(a)(1) .......................... Amend ................................ Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(a)(2) .......................... New ....................................

Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(a)(3) .......................... New ....................................

Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(a)(4) .......................... Redesignated ..................... Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(b)(1) .......................... Amend ................................ Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(b)(2) .......................... Amend ................................ Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(b)(2)(i) ....................... New ....................................

Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33097 COMPATIBILITY TABLE-Continued Compatibility Section Change Subject Existing New 35.57(b)(2)(ii) ...................... New ....................................Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(b)(2)(iii) ..................... New ....................................Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.57(b)(2)(iv) ..................... New ....................................Training for experienced Radiation Safety Officer, tele-therapy or medical physicist, authorized medical physi-cist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

35.65(a)(1)-(5) .................... Redesignated ..................... Authorization for calibration, transmission, and reference sources.

35.65(b) .............................. New ....................................Authorization for calibration, transmission, and reference sources.

35.65(b)(1) .......................... New ....................................Authorization for calibration, transmission, and reference sources.

35.65(b)(2) .......................... New ....................................Authorization for calibration, transmission, and reference sources.

35.65(c) ............................... New ....................................Authorization for calibration, transmission, and reference sources.

35.190(a) ............................ Amend ................................ Training for uptake, dilution, and excretion studies .............. B 35.190(c)(2) ........................ Amend ................................ Training for uptake, dilution, and excretion studies .............. B 35.190(c)(2)(i) ..................... New ....................................Training for uptake, dilution, and excretion studies ..............

35.190(c)(2)(ii) .................... New ....................................Training for uptake, dilution, and excretion studies ..............

35.204(b) ............................ Amend ................................ Permissible molybdenum-99, strontium-82, and strontium- H&S 85 concentrations.

35.204(e) ............................ New ....................................Permissible molybdenum-99, strontium-82, and strontium-85 concentrations. B 35.290(a) ............................ Amend ................................ Training for imaging and localization studies ........................ B 35.290(c)(1)(ii) .................... Amend ................................ Training for imaging and localization studies ........................ B 35.290(c)(2) ........................ Amend ................................ Training for imaging and localization studies ........................

35.290(c)(2)(i) ..................... New ....................................Training for imaging and localization studies ........................

35.290(c)(2)(ii) .................... New ....................................Training for imaging and localization studies ........................ B 35 .3 0 0 .................................

Amend ................................ Use of unsealed byproduct material for which a written di-rective is required.

35.390(a) ............................ Amend ................................ Training for use of unsealed byproduct material for which a B written directive is required. B 35.390(b)(1)(ii) (G)(3) ......... Amend ................................ Training for use of unsealed byproduct material for which a written directive is required. B 35.390(b)(2) ........................ Amend ................................ Training for use of unsealed byproduct material for which a written directive is required.

35.390(b)(2)(i) ..................... New ....................................Training for use of unsealed byproduct material for which a written directive is required.

35.390(b)(2)(ii) .................... I New .................................... Training for use of unsealed byproduct material for which a written directive is required. B 35.392(a) ............................ Amend ................................ Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). B 35.392(c)(3) ........................ Amend ................................ Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

35.392(c)(3)(i) ..................... New ....................................Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

35.392(c)(3)(ii) .................... New ....................................Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

35.394(a) ............................ Amend ................................ Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

35.394(c)(3) ........................ Amend ................................ Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

35.394(c)(3)(i) ..................... New .................................... Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

33098 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations COMPATIBILITY TABLE-Continued Compatibility Section Change Subject Existing New 35.394(c)(3)(ii) .................... New .................................... Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

35.396(a)(1) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(a)(2) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(a)(3) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(1) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(2) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(2)(vi) ................... Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(3) ........................ Amend Redesignated ......... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(3)(i) ..................... New .................................... Training for the parenteral administration of unsealed by-product material requiring a written directive.

35.396(b)(3)(ii) .................... New .................................... Training for the parenteral administration of unsealed by-product material requiring a written directive. C 35.400(a) ............................ Amend ................................ Use of sources for manual brachytherapy ............................ C 35.400(b) ............................ Amend ................................ Use of sources for manual brachytherapy ............................

35.433(a) ............................ Amend ................................ Strontium-90 sources for ophthalmic treatments .................. H&S 35.433(b) ............................ New .................................... Strontium-90 sources for ophthalmic treatments ..................

35.433(b)(1) ........................ New .................................... Strontium-90 sources for ophthalmic treatments ..................

35.433(b)(2) ........................ New .................................... Strontium-90 sources for ophthalmic treatments ..................

35.433(c) ............................. Redesignated ..................... Strontium-90 sources for ophthalmic treatments (Previously D 35.433(b)).

35.490(a) ............................ Amend ................................ Training for use of manual brachytherapy sources .............. B 35.490(b)(1)(ii) .................... Amend ................................ Training for use of manual brachytherapy sources .............. B 35.490(b)(3) ........................ Amend ................................ Training for use of manual brachytherapy sources .............. B 35.490(b)(3)(i) ..................... New .................................... Training for use of manual brachytherapy sources ..............

35.490(b)(3)(ii) .................... New .................................... Training for use of manual brachytherapy sources ..............

35.491 (b)(3) ........................ Amend ................................ Training for ophthalmic use of strontium-90 ......................... B 35.500(a) ............................ Amend ................................ Use of sealed sources and medical devices for diagnosis [C]

(Previously 35.500).

35.500(b) ............................ New .................................... Use of sealed sources and medical devices for diagnosis ...

35.500(c) ............................. New .................................... Use of sealed sources and medical devices for diagnosis ...

35.590 (a) ........................... Amend ................................ Training for use of sealed sources for diagnosis .................. B 35.590 (b) ........................... New .................................... Training for use of sealed sources for diagnosis .................. B 35.590 (c) ........................... Redesignated ..................... Training for use of sealed sources for diagnosis (Previously 35.590(b)). B 35.590 (d) ........................... Redesignated ..................... Training for use of sealed sources for diagnosis (Previously 35.590(c)). C 35.600(a) ............................ Amend ................................ Use of a sealed source in a remote afterloader unit, tele-therapy unit, or gamma stereotactic radiosurgery unit. C 35.600(b) ............................ Amend ................................ Use of a sealed source in a remote afterloader unit, tele-therapy unit, or gamma stereotactic radiosurgery unit.

35.610(d)(1) ........................ New .................................... Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.610(d)(2) ........................ Amend ................................ Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.610(g) ............................ Amend ................................ Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.655(a) ............................ Amend ................................ Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

35.690(a) ............................ Amend ................................ Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.690(b)(1)(ii) .................... Amend ................................ Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.690(b)(3) ........................ Amend ................................ Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.690(b)(3)(i) ..................... New .................................... Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

35.690(b)(3)(ii) .................... New .................................... Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33099 COMPATIBILITY TABLE-Continued Compatibility Section Change Subject Existing New 35.2024(c) ........................... New .................................... Records of authority and responsibilities for radiation pro- . ............... D tection programs.

35.2024(c)(1) ...................... New .................................... Records of authority and responsibilities for radiation pro- . ............... D tection programs.

35.2024(c)(2) ...................... New .................................... Records of authority and responsibilities for radiation pro- . ............... D tection programs.

35.2310 ............................... Amend ................................ Records of safety instruction ........ .. .. ........................ D D 35.2655(a) .......................... Amend ................................ Records of full-inspection servicing for teletherapy and D D gamma stereotactic radiosurgery units.

35.3045(a)(1) ...................... Amend ................................ Report and notification of a medical event ........................... C C 35.3045(a)(2) ...................... New .................................... Report and notification of a medical event for permanent ................ C implant brachytherapy.

35.3204(a) .......................... New .................................... Report and notification of an eluate exceeding permissible ................ C molybdenum-99, strontium-82, and strontium-85 con-centrations.

35.3204(b) .......................... New .................................... Written report of an eluate exceeding permissible molyb- . ............... C denum-99, strontium-82, and strontium-85 concentrations.

XIX. Coordination With the Advisory draft proposed rule was made public to Committee on Draft Final Rule, 10 CFR Committee on the Medical Uses of facilitate the ACMUI review in a public parts 30, 32, and 35," dated January 6, Isotopes forum. The ACMUI discussed the draft 2016, to the NRC on January 6, 2016.

The NRC staff consults with the proposed rule at two publicly held The NRC prepared a response to the ACMUI whenever it identifies an issue teleconferences on March 5 and March ACMUI recommendations and the with implementation of 10 CFR part 35 12, 2013. The ACMUI provided a final response is listed in the list of available regulations. Accordingly, issues report, "Advisory Committee on the documents, in Section XXIII.,

addressed by this rule have been Medical Uses of Isotopes Sub- "Availability of Documents."

discussed at ACMUI meetings over the Committee on Proposed Rule," dated XX. Consistency With Medical Policy last several years. The ACMUI meetings April 5, 2013, to the NRC on April 9, Statement are transcribed. Full transcripts of the 2013.

ACMUI meetings can be found online in While the ACMUI was supportive of The amendments to 10 CFR part 35 the NRC Library at http://www.nrc.gov/ most of the proposed amendments, it are consistent with the Commission's reading-rm/doc-collections/acmui/tr.In expressed concerns on some issues and Medical Use Policy Statement published addition, in the SRM to SECY-10-0062, provided its recommendations on those August 3, 2000 (65 FR 47654). This rule the Commission specifically directed issues. Several comments resulted in is consistent with the Commission's the NRC staff to engage the ACMUI in revisions to the discussion section of the statement because it balances the developing the ME definition criterion proposed rule to provide additional interests of the patient with the for permanent implant brachytherapy. emphasis or clarity. However, the NRC flexibility needed by the AU to take the Further, the amendments that revise did not accept all of the ACMUI actions that he or she deems medically T&E requirements to eliminate recommendations. The necessary, while continuing to enable preceptor attestation for board-certified recommendations that the NRC staff did the NRC to detect deficiencies in individuals, change the language of the not accept were discussed in a processes, procedures, and training, as attestation, and allow a residency document entitled, "NRC Staff well as any misapplication of byproduct director to provide preceptor Responses to the ACMUI Comments on materials.

attestations were initiated by the the Draft Part 35 Proposed Rule,"

XXI. Voluntary Consensus Standards ACMUI in its briefing to the Enclosure 5, to SECY-13-0084.

Commission held on April 29, 2008 In addition, the ACMUI The National Technology Transfer (discussed in detail in Item b, Section recommended that for permanent and Advancement Act of 1995 (Pub. L.

III., Discussion, of this document). implant brachytherapy procedures, 104-113) requires that Federal agencies Similarly, the issue of naming more licensees be allowed to use total source use technical standards that are than one RSO was initiated by the strength as a substitute for total dose for developed or adopted by voluntary ACMUI at the June 2007 ACMUI determining MEs until the 10 CFR part consensus standards bodies unless the meeting (discussed in detail in Item d in 35 rulemaking is completed. In use of such a standard is inconsistent Section III., Discussion, of this response, on July 9, 2013, the with applicable law or otherwise document). Finally, the entire ACMUI Commission issued an interim impractical. In this final rule, the NRC meeting held on April 20-21, 2011, was enforcement policy (78 FR 41125) that is amending its medical use regulations devoted to discussion of the rulemaking addressed this issue. related to ME definitions for permanent issues addressed in the proposed rule, On October 6, 2015, the NRC implant brachytherapy; T&E so that the NRC staff would be better provided the preliminary draft final rule requirements for AUs, medical able to understand ACMUI's position to the ACMUI for a 90-day review. The physicists, RSOs, and nuclear and views on the issues raised. ACMUI held a public teleconference on pharmacists; completing action on In December 2012, the NRC provided January 6, 2016, and provided a final PRM-35-20 to "grandfather" certain the preliminary draft proposed rule to report, "Advisory Committee on the experienced individuals; measuring Mo-the ACMUI for a 90-day review. The Medical Uses of Isotopes Sub- 99 contamination for each elution and

33100 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations reporting of failed breakthrough tests; XXII. Availability of Guidance the implementation of the requirements naming ARSOs on a medical license; Published elsewhere in this issue of in this final rule.

and making several minor clarifications, the Federal Register, the NRC is issuing XXIII. Availability of Documents This action does not constitute the new guidance, "Guidance for the Final establishment of a standard that Rule 'Medical Use of Byproduct The documents identified in the contains generally applicable Material-Medical Events, Definitions, following table are available to requirements. Training and Experience, and Clarifying interested persons through one or more Amendments," (NRC-2014-0030), for of the following methods, as indicated.

Date Document ADAMS accession No.

03/01/2004 ........ 03/01/2004 Transcript of Advisory Committee on the Medical Uses of Isotopes Meeting in Rockville MD, ML040780651 Pages 1-194.

06/28/2005 ........ Transcript of the Advisory Committee on the Medical Uses of Isotopes Medical Event Subcommittee Meet- ML052360415 ing.

12/27/2005 ........ SECY-05-0234, "Adequacy of Medical Event Definitions in 10 CFR 35.3045, and Communicating Associ- ML053180408 ated Risks to the Public".

02/15/2006 ........ SRM-SECY-05-0234, "Adequacy of Medical Event Definitions in 10 CFR 35.3045, and Communicating ML060460594 Associated Risks to the Public".

09/10/2006 ........ PRM-35-20, "AAPM Petition for Rulemaking to Amend 10 CFR 35.57, Training for Experience Radiation ML062620129 Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist," filed by E. Russell Ritenour.

06/12/2007 ........ Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, June 12, 2007, ML072340094 Pages 1-325.

04/29/2008 ........ M080429-Commission Meeting with the Advisory Committee on the Medical Uses of Isotopes, Transcript ML081270628 05/15/2008 ........ SRM-M080429, Meeting with Advisory Committee on the Medical Uses of Isotopes (ACMUI) 1:30 p.m., ML081360319 Tuesday, April 29, 2008.

11/20/2008 ........ SECY-08-0179, "Recommendations on Amending Preceptor Attestation Requirements in 10 CFR part ML083170176 35, Medical Use of Byproduct Material".

01/16/2009 ........ SRM-SECY-08-0179, "Recommendations on Amending Preceptor Attestation Requirements in 10 CFR ML090160275 part 35, Medical Use of Byproduct Material".

05/18/2010 ........ SECY-10-0062, "Reproposed Rule: Medical Use of Byproduct Material-Amendments/Medical Event ML100890121 Definitions".

07/08/2010 ........ M100708B-Commission Briefing on "Proposed Rule on Part 35 Medical Events Definitions-Permanent ML101930532 Implant Brachytherapy," Transcript.

08/10/2010 ........ SRM-SECY-10-0062, "Reproposed Rule: Medical Use of Byproduct Material-Amendments/Medical ML102220233 Event Definitions (RIN 3150-AI26)".

10/20/2010 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, Open Session, ML103350657 October 20, 2010, Pages 1-168.

10/20/2010 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Interim ML103540385 Report.

04/11/2011 ........ Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, April 11, ML 1174A070 2011, Pages 1-226.

05/16/2011 ........ Part 35 Preliminary Draft Proposed Rule Language, provided for ACMUI review .......................................... ML1139042005/20/2011 ........ FSME-1 1-044, "Opportunity to Comment on Preliminary Proposed Rule Language for Medical Use Regu- ML 11400231 lations".

06/20/2011 ........ Public Meeting Summary for Part 35 Medical Workshop, June 20-21, 2011 ................................................. MLl 11930470 08/11/2011 ........ Transcript of Public Workshop for Discussion of Topics Related to NRC's Medical Regulations, August 11, ML112900103 2011, Pages 1-240.

08/12/2011 ........ Transcript of Public Workshop for Discussion of Topics Related to NRC's Medical Regulations, August 12, ML112900185 2011, Pages 1-192.

10/18/2011 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Final ML11292A139 Report.

10/18/2011 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meet- ML12062A275 ing, October 18, 2011, Pages 1-77.

11/30/2011 ........ The American Society for Radiation Oncology (ASTRO) letter to the Chairman of the ACMUI ..................... ML11341A051 02/07/2012 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Permanent Implant Brachytherapy Revised ML12038A279 Final Report.

02/07/2012 ........ Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference ML12242A101 Meeting, February 7, 2012, Pages 1-85.

02/13/2012 ........ AS T RO lette r to the C hairm an of the A C MUI .................................................................................................. ML12044A358 04/05/2012 ........ SECY-12-0053, "Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Pro- ML12072A306 grams".

04/24/2012 ........ Transcript of Commission Meeting April 24, 2012, before Commission vote on SECY-12-0053, "Rec- ML12116A294 ommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs".

08/13/2012 ........ SRM-SECY-12-0053, "Recommendations on Regulatory Changes for Permanent Implant Brachytherapy ML122260211 Programs".

01/14/2013 ........ Part 35 Preliminary Draft Proposed Rule Federal Register Notice, provided for ACMUI review .................. ML13014A487 03/05/2013 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meet- ML13175A030 ing, March 5, 2013, Pages 1-111.

03/12/2013 ........ Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference Meet- ML13175A028 ing, March 12, 2013, Pages 1-115.

03/28/2013 ........ Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Proposed Rule, 10 CFR ML13071A690 parts 30, 32 and 35, Final Report.

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33101 Date Document ADAMS No.

accession 08/08/2013 ........SECY-13-0084, "Proposed Rule: Medical Use of Byproduct Material-Medical Event Definitions, Training ML13179A068 and Experience, and Clarifying Amendments (RIN 3150-AI63)".

08/08/2013 ........SECY-13-0085, Enclosure 5, "NRC Staff Responses to the ACMUI Comments on the Draft Part 35 Pro- ML13179A073 posed Rule".

01/06/2014 ........SRM-SECY-13-0084, "Proposed Rule: Medical Use of Byproduct Material-Medical Event Definitions, ML14007A044 Training and Experience, and Clarifying Amendments (RIN 3150-AI63)".

07/23/2014 ........Draft Environmental Assessment: Proposed Rule Amending 10 CFR parts 30, 32, and 35-Medical Use of ML14184A621 Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments.

07/23/2014 ........Draft Regulatory Analysis: Proposed Rule: Amendments to Medical Use of Byproduct Material Regula- ML14184A620 tions, 10 CFR parts 30, 32, and 35.

08/15/2014 ........FSME-14-078, "Opportunity to Comment on Proposed Amendments to Medical Use of Byproduct Mate- ML14226A319 rial Regulations, 10 CFR 30, 32, and 35 and Notification of October 8, 2014 Public Meeting".

10/08/2014 ........Part 35 Proposed Rule Public Meeting Transcript, Pages 1-171, October 8, 2014 .......................................

ML15026A317 02/12/2015 ........Meeting Summary: Public Meeting Between Spectrum Pharmaceuticals, Inc., and the Nuclear Regulatory ML15054A215 Commission (NRC) Regarding Modification of the Training and Experiences Requirements for Beta Emitter Products.

06/16/2015 ........Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Teleconference ML15285A016 Meeting, June 16, 2015, Pages 1-109.

09/21/2015 ........Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience for Authorized ML15271A124 Users of Alpha and Beta Emitters Draft Subcommittee Report.

10/08/2015 ........Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, October 8, ML15357A551 2015, Open Session, Pages 1-255.

10/09/2015 ........Final Transcript of Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, October 9, ML15357A552 2015, Open Session, Pages 1-262.

01/06/2016 ........Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft Final Rule, 10 ML16007A771 CFR parts 30, 32 and 35, Final Report.

03/16/2016 ........Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience for Authorized ML16089A271 Users of Alpha and Beta Emitters under 10 CFR 35.390, Final Report.

June 2016 ......... M L16 124B 050 Final E nvironm ental Assessm ent ...............................................................................

June 20 16 .........

Fina lR eg ulato ryA na lysis M L16 124 B0 34 June 2016 .........NRC Staff Response to the Advisory Committee on the Medical Uses of Isotopes' Part 35 Draft Final ML16124B068 Rule-Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments; Final Comments.".

June 2016 .........Summary of Specific Agreement State and Organization of Agreement States Comments on the Draft ML16124B069 Final Rule and Staff Response.

Decem ber 20 16 ML16126A441 Final Im plem enting G uidance .................................................................................

List of Subjects as amended; and 5 U.S.C. 552 and 553, PART 32-SPECIFIC DOMESTIC the NRC is adopting the following LICENSES TO MANUFACTURE OR 10 CFR Part30 amendments to 10 CFR parts 30, 32, and TRANSFER CERTAIN ITEMS Byproduct material, Criminal 35: CONTAINING BYPRODUCT MATERIAL penalties, Government contracts, Intergovernmental relations, Isotopes, PART 30-RULES OF GENERAL

• 3. The authority citation for part 32 Nuclear energy, Nuclear materials, APPLICABILITY TO DOMESTIC continues to read as follows:

Penalties, Radiation protection, LICENSING OF BYPRODUCT Authority: Atomic Energy Act of 1954, Reporting and recordkeeping MATERIAL secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 requirements, Whistleblowing. U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, m 1. The authority citation for part 30 2282, 2021); Energy Reorganization Act of 10 CFR Part32 continues to read as follows: 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C.

Byproduct material, Criminal Authority: Atomic Energy Act of 1954, 3504 note.

penalties, Labeling, Nuclear energy, secs. 11, 81, 161, 181, 182, 183, 184, 186,

• 4. In § 32.72:

Nuclear materials, Radiation protection, 187, 223, 234, 274 (42 U.S.C. 2014, 2111, m a. Revise paragraphs (a)(4)

Reporting and recordkeeping 2201, 2231, 2232, 2233, 2234, 2236, 2237, introductory text and (b)(5)(i);

requirements. 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. m b. Redesignate paragraph (d) as 10 CFR Part35 5841, 5842, 5846, 5851); 44 U.S.C. 3504 note. paragraph (e); and m c. Add new paragraph (d).

Biologics, Byproduct material,

• 2. In § 30.34, add a third sentence to The revisions and addition read as Criminal penalties, Drugs, Health paragraph (g) to read as follows: follows:

facilities, Health professions, Labeling, Medical devices, Nuclear energy, §30.34 Terms and conditions of licenses. §32.72 Manufacture, preparation, or Nuclear materials, Occupational safety transfer for commercial distribution of and health, Penalties, Radiation (g) * *

• The licensee shall report the radioactive drugs containing byproduct protection, Reporting and recordkeeping results of any test that exceeds the material for medical use under part 35.

requirements. permissible concentration listed in (a) * *

• For the reasons set out in the § 35.204(a) of this chapter at the time of (4) The applicant commits to the preamble and under the authority of the generator elution, in accordance with following labeling requirements:

Atomic Energy Act of 1954, as amended; § 35.3204 of this chapter. * * * *

• the Energy Reorganization Act of 1974, * * * * * (b)* *

• 33102 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations (5) * *

• and experience required for an applicable to radiation safety that are (i) A copy of each individual's individual to become an authorized not addressed in, or differ from, certification by a specialty board whose user, an authorized medical physicist, subparts A through C, L, and M of this certification process has been an authorized nuclear pharmacist, a part; recognized by the Commission or an Radiation Safety Officer, or an Associate (2) Identification of and commitment Agreement State as specified in Radiation Safety Officer. to follow the applicable radiation safety

§ 35.55(a) of this chapter; or program requirements in subparts D

• 7. In § 35.8, revise paragraph (b) to through H of this part that are (d) A licensee shall satisfy the read as follows: appropriate for the specific § 35.1000 labeling requirements in paragraph medical use; (a)(4) of this section. §35.8 Information collection (3) Any additional specific

• * * *

• requirements: OMB approval. information on-(i) Radiation safety precautions and PART 35-MEDICAL USE OF (b) The approved information instructions; BYPRODUCT MATERIAL collection requirements contained in (ii) Methodology for measurement of this part appear in §§ 35.6, 35.12, 35.13, dosages or doses to be administered to u 5. The authority citation for part 35 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, patients or human research subjects; continues to read as follows: 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, and Authority: Atomic Energy Act of 1954, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, (iii) Calibration, maintenance, and secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 35.92, 35.190, 35.204, 35.290, 35.310, repair of instruments and equipment U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 35.315, 35.390, 35.392, 35.394, 35.396, necessary for radiation safety; and 2282, 2021); Energy Reorganization Act of 35.404, 35.406, 35.410, 35.415, 35.432, (4) Any other information requested 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); 35.433, 35.490, 35.491, 35.590, 35.604, by the Commission in its review of the 44 U.S.C. 3504 note. 35.605, 35.610, 35.615, 35.630, 35.632, application.

• 6. In § 35.2, add in alphabetical order 35.633, 35.635, 35.642, 35.643, 35.645, definitions for Associate Radiation 35.647, 35.652, 35.655, 35.690, 35.1000,

• 9. In § 35.13:

Safety Officer and Ophthalmicphysicist 35.2024, 35.2026, 35.2040, 35.2041, m a. Revise paragraph (b);

and revise the definition of Preceptorto 35.2060, 35.2061, 35.2063, 35.2067,

• b. Redesignate paragraphs (d) through read as follows: 35.2070, 35.2075, 35.2080, 35.2092, (g) as paragraphs (e) through (h);

35.2204, 35.2310, 35.2404, 35.2406, m c. Add new paragraph (d);

§ 35.2 Definitions. 35.2432, 35.2433, 35.2605, 35.2610, m c. Revise newly redesignated 35.2630, 35.2632, 35.2642, 35.2643, paragraphs (g) and (h); and Associate Radiation Safety Officer 35.2645, 35.2647, 35.2652, 35.2655,

• d. Add paragraph (i).

means an individual who- 35.3045, 35.3047, 35.3067, and 35.3204. The revisions and additions read as (1) Meets the requirements in §§ 35.50 * * * *

• follows:

and 35.59; and

• 8. In § 35.12, revise paragraphs (b)(1),

(2) Is currently identified as an §35.13 License amendments.

(c)(1) introductory text, (c)(1)(ii), and (d) * * * *

• Associate Radiation Safety Officer for to read as follows:

the types of use of byproduct material (b) Before it permits anyone to work for which the individual has been §35.12 Application for license, as an authorized user, authorized assigned duties and tasks by the amendment, or renewal. medical physicist, ophthalmic physicist, Radiation Safety Officer on- or authorized nuclear pharmacist under (i) A specific medical use license (b)* *

• the license, except-issued by the Commission or an (1) Filing an original NRC Form 313, (1) For an authorized user, an Agreement State; or "Application for Material License," that individual who meets the requirements (ii) A medical use permit issued by a includes the facility diagram, in §§ 35.59 and 35.190(a), 35.290(a),

Commission master material licensee. equipment, and training and experience 35.390(a), 35.392(a), 35.394(a),

qualifications of the Radiation Safety 35.490(a), 35.590(a), and 35.690(a);

Ophthalmicphysicist means an Officer, Associate Radiation Safety (2) For an authorized nuclear individual who- Officer(s), authorized user(s), authorized pharmacist, an individual who meets (1) Meets the requirements in medical physicist(s), ophthalmic the requirements in §§ 35.55(a) and

§§ 35.433(a)(2) and 35.59; and physicist(s), and authorized nuclear 35.59; (2) Is identified as an ophthalmic pharmacist(s); and (3) For an authorized medical physicist on a- * * * *

• physicist, an individual who meets the (i) Specific medical use license issued (c) * *

• requirements in §§ 35.51(a) and 35.59; by the Commission or an Agreement (1) Submitting an original of either- (4) An individual who is identified as State; * * * *

• an authorized user, an authorized (ii) Permit issued by a Commission or (ii) A letter containing all information nuclear pharmacist, authorized medical Agreement State broad scope medical required by NRC Form 313; and physicist, or an ophthalmic physicist-use licensee; * * * * *

(iii) Medical use permit issued by a (d) In addition to the requirements in (d) Before it permits anyone to work Commission master material licensee; or paragraphs (b) and (c) of this section, an as an Associate Radiation Safety Officer, (iv) Permit issued by a Commission application for a license or amendment or before the Radiation Safety Officer master material licensee broad scope for medical use of byproduct material as assigns duties and tasks to an Associate medical use permittee. described in § 35.1000 must also Radiation Safety Officer that differ from include: those for which this individual is Preceptormeans an individual who (1) Any additional aspects of the authorized on the license; provides, directs, or verifies training medical use of the material that are

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33103 (g) Before it changes the address(es) of (2) The licensee permits an individual requirements. A licensee's management use identified in the application or on qualified to be a Radiation Safety Officer may appoint, in writing, one or more the license; under §§ 35.50 and 35.59 to function as Associate Radiation Safety Officers to (h) Before it revises procedures a temporary Radiation Safety Officer support the Radiation Safety Officer.

required by §§ 35.610, 35.642, 35.643, and to perform the functions of a The Radiation Safety Officer, with and 35.645, as applicable, where such Radiation Safety Officer in accordance written agreement of the licensee's revision reduces radiation safety; and with § 35.24(c); management, must assign the specific (i) Before it receives a sealed source (3) The licensee's mailing address duties and tasks to each Associate from a different manufacturer or of a changes; Radiation Safety Officer. These duties different model number than authorized (4) The licensee's name changes, but and tasks are restricted to the types of by its license unless the sealed source the name change does not constitute a use for which the Associate Radiation is used for manual brachytherapy, is transfer of control of the license as Safety Officer is listed on a license. The listed in the Sealed Source and Device described in § 30.34(b) of this chapter; Radiation Safety Officer may delegate Registry, and is in a quantity and for an (5) The licensee has added to or duties and tasks to the Associate isotope authorized by the license. changed the areas of use identified in Radiation Safety Officer but shall not

• 10. In § 35.14, revise paragraphs (a) the application or on the license where delegate the authority or responsibilities and (b) to read as follows: byproduct material is used in for implementing the radiation accordance with either § 35.100 or protection program.

§35.14 Notifications. § 35.200 if the change does not include (c) For up to 60 days each year, a (a) A licensee shall provide the addition or relocation of either an area licensee may permit an individual Commission, no later than 30 days after where PET radionuclides are produced qualified to be a Radiation Safety the date that the licensee permits an or a PET radioactive drug delivery line Officer, under §§ 35.50 and 35.59, to individual to work under the provisions from the PET radionuclide/PET function as a temporary Radiation of § 35.13(b) as an authorized user, radioactive drug production area; or Safety Officer and to perform the authorized medical physicist, (6) The licensee obtains a sealed functions of a Radiation Safety Officer, ophthalmic physicist, or authorized source for use in manual brachytherapy as provided in paragraph (g) of this nuclear pharmacist- from a different manufacturer or with a section, if the licensee takes the actions (1) A copy of the board certification different model number than authorized required in paragraphs (b), (e), (g), and and, as appropriate, verification of by its license for which it did not (h) of this section and notifies the completion of: require a license amendment as Commission in accordance with (i) Training for the authorized medical provided in § 35.13(i). The notification § 35.14(b).

physicist under § 35.51(c); must include the manufacturer and (ii) Any additional case experience model number of the sealed source, the 0 13. In § 35.40:

required in § 35.390(b)(1)(ii)(G) for an isotope, and the quantity per sealed m a. Revise paragraph (b)(5);

authorized user under § 35.300; or source.

• b. Redesignate paragraph (b)(6) as (iii) Device specific training in paragraph (b)(7);

§ 35.690(c) for the authorized user under

• 11. In § 35.15, revise paragraphs (c) mc. Add new paragraph (b)(6);

§ 35.600; or and (e) to read as follows:

• d. Revise newly redesignated (2) A copy of the Commission or paragraph (b)(7);

Agreement State license, the permit §35.15 Exemptions regarding Type A m e. Redesignate paragraph (c) issued by a Commission master material specific licenses of broad scope. introductory text as paragraph (c)(1);

licensee, the permit issued by a and Commission or Agreement State (c) The provisions of § 35.13(f)

• f. Redesignate paragraph (c)(1) as licensee of broad scope, the permit regarding additions to or changes in the paragraph (c)(2).

issued by a Commission master material areas of use at the addresses identified The revisions and addition read as in the application or on the license; follows:

license broad scope permittee, or documentation that only accelerator- §35.40 Written directives.

produced radioactive materials, discrete (e) The provisions of § 35.14(b)(1) for sources of radium-226, or both, were an authorized user, an authorized (b)* *

• used for medical use or in the practice nuclear pharmacist, an authorized (5) For high dose-rate remote of nuclear pharmacy at a Government medical physicist, or an ophthalmic afterloading brachytherapy: The agency or Federally recognized Indian physicist; radionuclide, treatment site, dose per Tribe before November 30, 2007, or at fraction, number of fractions, and total all other locations of use before August

• 12. In § 35.24, revise paragraphs (b) dose; 8, 2009, or an earlier date as noticed by and (c) to read as follows: (6) For permanent implant the NRC for each individual whom the brachytherapy:

licensee permits to work under the §35.24 Authority and responsibilities for (i) Before implantation: The treatment provisions of this section. the radiation protection program. site, the radionuclide, and the total (b) A licensee shall notify the source strength; and Commission no later than 30 days after: (b) A licensee's management shall (ii) After implantation but before the (1) An authorized user, an authorized appoint a Radiation Safety Officer who patient leaves the post-treatment nuclear pharmacist, a Radiation Safety agrees, in writing, to be responsible for recovery area: The treatment site, the Officer, an Associate Radiation Safety implementing the radiation protection number of sources implanted, the total Officer, an authorized medical program. The licensee, through the source strength implanted, and the date; physicist, or ophthalmic physicist Radiation Safety Officer, shall ensure or permanently discontinues performance that radiation safety activities are being (7) For all other brachytherapy, of duties under the license or has a performed in accordance with licensee- including low, medium, and pulsed name change; approved procedures and regulatory dose rate remote afterloaders:

33104 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations (i) Before implantation: The treatment (ii) Have 5 or more years of (A) Shipping, receiving, and site, radionuclide, and dose; and professional experience in health performing related radiation surveys; (ii) After implantation but before physics (graduate training may be (B) Using and performing checks for completion of the procedure: The substituted for no more than 2 years of proper operation of instruments used to radionuclide; treatment site; number of the required experience) including at determine the activity of dosages, sources; total source strength and least 3 years in applied health physics; survey meters, and instruments used to exposure time (or the total dose); and and measure radionuclides; date. (iii) Pass an examination administered (C) Securing and controlling by diplomates of the specialty board, byproduct material; which evaluates knowledge and (D) Using administrative controls to

• 14. In § 35.41, revise paragraphs (b)(3) competence in radiation physics and avoid mistakes in the administration of and (4) and add paragraphs (b)(5) and instrumentation, radiation protection, byproduct material; (6) to read as follows:

mathematics pertaining to the use and (E) Using procedures to prevent or

§35.41 Procedures for administrations measurement of radioactivity, radiation minimize radioactive contamination requiring a written directive. biology, and radiation dosimetry; or and using proper decontamination (2)(i) Hold a master's or doctor's procedures; (b)* *

• degree in physics, medical physics, (F) Using emergency procedures to (3) Checking both manual and other physical science, engineering, or control byproduct material; and computer-generated dose calculations; applied mathematics from an accredited (G) Disposing of byproduct material; (4) Verifying that any computer- college or university; and generated dose calculations are correctly (ii) Have 2 years of full-time practical (2) This individual must obtain a transferred into the consoles of training and/or supervised experience written attestation, signed by a therapeutic medical units authorized by in medical physics- preceptor Radiation Safety Officer or

§§ 35.600 or 35.1000; (A) Under the supervision of a Associate Radiation Safety Officer who (5) Determining if a medical event, as medical physicist who is certified in has experience with the radiation safety defined in § 35.3045, has occurred; and medical physics by a specialty board aspects of similar types of use of (6) Determining, for permanent recognized by the Commission or an byproduct material for which the implant brachytherapy, within 60 Agreement State; or individual is seeking approval as a (B) In clinical nuclear medicine calendar days from the date the implant Radiation Safety Officer or an Associate facilities providing diagnostic or was performed, the total source strength Radiation Safety Officer. The written therapeutic services under the direction administered outside of the treatment attestation must state that the individual of physicians who meet the site compared to the total source has satisfactorily completed the requirements for authorized users in strength documented in the post- requirements in paragraphs (b)(1) and implantation portion of the written §§ 35.57, 35.290, or 35.390; and (d) of this section, and is able to (iii) Pass an examination, directive, unless a written justification independently fulfill the radiation administered by diplomates of the of patient unavailability is documented. safety-related duties as a Radiation specialty board, that assesses knowledge Safety Officer or as an Associate and competence in clinical diagnostic

• 15. Revise § 35.50 to read as follows: Radiation Safety Officer for a medical radiological or nuclear medicine use license; or physics and in radiation safety; or

§35.50 Training for Radiation Safety (b)(1) Has completed a structured (c)(1) Is a medical physicist who has Officer and Associate Radiation Safety been certified by a specialty board Officer. educational program consisting of both:

(i) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and whose certification process has been Except as provided in § 35.57, the laboratory training in the following recognized by the Commission or an licensee shall require an individual areas- Agreement State under § 35.51(a), has fulfilling the responsibilities of the (A) Radiation physics and experience with the radiation safety Radiation Safety Officer or an instrumentation; aspects of similar types of use of individual assigned duties and tasks as (B) Radiation protection; byproduct material for which the an Associate Radiation Safety Officer as (C) Mathematics pertaining to the use licensee seeks the approval of the provided in § 35.24 to be an individual and measurement of radioactivity; individual as Radiation Safety Officer or who- (D) Radiation biology; and an Associate Radiation Safety Officer, (a) Is certified by a specialty board (E) Radiation dosimetry; and and meets the requirements in whose certification process has been (ii) One year of full-time radiation paragraph (d) of this section; or recognized by the Commission or an safety experience under the supervision (2) Is an authorized user, authorized Agreement State and who meets the of the individual identified as the medical physicist, or authorized nuclear requirements in paragraph (d) of this Radiation Safety Officer on a pharmacist identified on a Commission section. The names of board Commission or an Agreement State or an Agreement State license, a permit certifications that have been recognized license or permit issued by a issued by a Commission master material by the Commission or an Agreement Commission master material licensee licensee, a permit issued by a State are posted on the NRC's Medical that authorizes similar type(s) of use(s) Commission or an Agreement State Uses Licensee Toolkit web page. To of byproduct material. An Associate licensee of broad scope, or a permit have its certification process recognized, Radiation Safety Officer may provide issued by a Commission master material a specialty board shall require all supervision for those areas for which license broad scope permittee, has candidates for certification to: (1)(i) the Associate Radiation Safety Officer is experience with the radiation safety Hold a bachelor's or graduate degree authorized on a Commission or an aspects of similar types of use of from an accredited college or university Agreement State license or permit byproduct material for which the in physical science or engineering or issued by a Commission master material licensee seeks the approval of the biological science with a minimum of licensee. The full-time radiation safety individual as the Radiation Safety 20 college credits in physical science; experience must involve the following- Officer or Associate Radiation Safety

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33105 Officer, and meets the requirements in preceptor authorized medical physicist American Board of Radiology; American paragraph (d) of this section; or who meets the requirements in § 35.51, Board of Nuclear Medicine; American (3) Has experience with the radiation § 35.57, or equivalent Agreement State Board of Science in Nuclear Medicine; safety aspects of the types of use of requirements for an authorized medical Board of Pharmaceutical Specialties in byproduct material for which the physicist for each type of therapeutic Nuclear Pharmacy; American Board of individual is seeking simultaneous medical unit for which the individual is Medical Physics in radiation oncology approval both as the Radiation Safety requesting authorized medical physicist physics; Royal College of Physicians Officer and the authorized user on the status. and Surgeons of Canada in nuclear same new medical use license or new medicine; American Osteopathic Board medical use permit issued by a

• 17. In § 35.55, revise paragraphs (a) of Radiology; or American Osteopathic Commission master material license. introductory text and (b)(2) to read as Board of Nuclear Medicine on or before The individual must also meet the follows: October 24, 2005, need not comply with requirements in paragraph (d) of this the training requirements of § 35.50 to section. §35.55 Training for an authorized nuclear be identified as a Radiation Safety (d) Has training in the radiation pharmacist. Officer or as an Associate Radiation safety, regulatory issues, and emergency Safety Officer on a Commission or an procedures for the types of use for (a) Is certified by a specialty board Agreement State license or Commission which a licensee seeks approval. This whose certification process has been master material license permit for those training requirement may be satisfied by recognized by the Commission or an materials and uses that these completing training that is supervised Agreement State. The names of board individuals performed on or before by a Radiation Safety Officer, an certifications that have been recognized October 24, 2005.

Associate Radiation Safety Officer, by the Commission or an Agreement (3) Any individual certified by the authorized medical physicist, State are posted on the NRC's Medical American Board of Radiology in authorized nuclear pharmacist, or Uses Licensee Toolkit web page. To therapeutic radiological physics, authorized user, as appropriate, who is have its certification process recognized, Roentgen ray and gamma ray physics, x-authorized for the type(s) of use for a specialty board shall require all ray and radium physics, or radiological which the licensee is seeking approval. candidates for certification to: physics, or certified by the American Board of Medical Physics in radiation

• 16. In § 35.51, revise paragraphs (a)

(b)* *

• oncology physics, on or before October introductory text, (a)(2)(i), and (b)(2) to (2) Has obtained written attestation, 24, 2005, need not comply with the read as follows:

signed by a preceptor authorized training requirements for an authorized

§35.51 Training for an authorized medical nuclear pharmacist, that the individual medical physicist described in § 35.51, physicist. has satisfactorily completed the for those materials and uses that these requirements in paragraph (b)(1) of this individuals performed on or before (a) Is certified by a specialty board section and is able to independently October 24, 2005.

whose certification process has been fulfill the radiation safety-related duties (4) A Radiation Safety Officer, a recognized by the Commission or an as an authorized nuclear pharmacist. medical physicist, or a nuclear Agreement State and who meets the pharmacist, who used only accelerator-

• 18. In § 35.57, revise paragraphs (a) requirements in paragraph (c) of this produced radioactive materials, discrete and (b) to read as follows: sources of radium-226, or both, for section. The names of board certifications that have been recognized §35.57 Training for experienced Radiation medical uses or in the practice of by the Commission or an Agreement Safety Officer, teletherapy or medical nuclear pharmacy at a Government physicist, authorized medical physicist, agency or Federally recognized Indian State are posted on the NRC's Medical authorized user, nuclear pharmacist, and Uses Licensee Toolkit web page. To Tribe before November 30, 2007, or at authorized nuclear pharmacist. all other locations of use before August have its certification process recognized, (a)(1) An individual identified on a a specialty board shall require all 8, 2009, or an earlier date as noticed by Commission or an Agreement State the NRC, need not comply with the candidates for certification to: license or a permit issued by a training requirements of § 35.50, § 35.51 Commission or an Agreement State or § 35.55, respectively, when (2) * *

• broad scope licensee or master material performing the same uses. A nuclear (i) Under the supervision of a medical license permit or by a master material pharmacist, who prepared only physicist who is certified in medical license permittee of broad scope as a radioactive drugs containing physics by a specialty board whose Radiation Safety Officer, a teletherapy accelerator-produced radioactive certification process has been or medical physicist, an authorized materials, or a medical physicist, who recognized under this section by the medical physicist, a nuclear pharmacist used only accelerator-produced Commission or an Agreement State; or or an authorized nuclear pharmacist on radioactive materials, at the locations or before January 14, 2019 need not and during the time period identified in (b)* *

• comply with the training requirements this paragraph, qualifies as an (2) Has obtained written attestation of § 35.50, § 35.51, or § 35.55, authorized nuclear pharmacist or an that the individual has satisfactorily respectively, except the Radiation Safety authorized medical physicist, completed the requirements in Officers and authorized medical respectively, for those materials and paragraphs (b)(1) and (c) of this section, physicists identified in this paragraph uses performed before these dates, for and is able to independently fulfill the must meet the training requirements in the purposes of this chapter.

radiation safety-related duties as an § 35.50(d) or § 35.51(c), as appropriate, (b)(1) Physicians, dentists, or authorized medical physicist for each for any material or uses for which they podiatrists identified as authorized type of therapeutic medical unit for were not authorized prior to this date. users for the medical use of byproduct which the individual is requesting (2) Any individual certified by the material on a license issued by the authorized medical physicist status. The American Board of Health Physics in Commission or an Agreement State, a written attestation must be signed by a Comprehensive Health Physics; permit issued by a Commission master

33106 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations material licensee, a permit issued by a (iv) For uses authorized under smaller of 7.4 MBq (200 gtCI) or 1000 Commission or an Agreement State § 35.500, a physician who was certified times the quantities in appendix B of broad scope licensee, or a permit issued on or before October 24, 2005, in part 30 of this chapter; or by a Commission master material radiology, diagnostic radiology, (5) Technetium-99m in amounts as license broad scope permittee on or therapeutic radiology, or radiation needed.

before January 14, 2019, who perform oncology by the American Board of (b) Byproduct material in sealed only those medical uses for which they Radiology; nuclear medicine by the sources authorized by this provision were authorized on or before that date American Board of Nuclear Medicine; shall not be:

need not comply with the training diagnostic radiology or radiology by the (1) Used for medical use as defined in requirements of subparts D through H of American Osteopathic Board of § 35.2 except in accordance with the this part. Radiology; or nuclear medicine by the requirements in § 35.500; or (2) Physicians, dentists, or podiatrists Royal College of Physicians and (2) Combined (i.e., bundled or not identified as authorized users for the Surgeons of Canada. aggregated) to create an activity greater medical use of byproduct material on a (3) Physicians, dentists, or podiatrists than the maximum activity of any single license issued by the Commission or an who used only accelerator-produced sealed source authorized under this Agreement State, a permit issued by a radioactive materials, discrete sources of section.

radium-226, or both, for medical uses (c) A licensee using calibration, Commission master material licensee, a performed at a Government agency or transmission, and reference sources in permit issued by a Commission or an Federally recognized Indian Tribe accordance with the requirements in Agreement State broad scope licensee, before November 30, 2007, or at all paragraph (a) or (b) of this section need or a permit issued by a Commission other locations of use before August 8, not list these sources on a specific master material license of broad scope 2009, or an earlier date as noticed by the medical use license.

on or before October 24, 2005, need not comply with the training requirements NRC, need not comply with the training

• 20. In § 35.190, revise paragraphs (a) of subparts D through H of this part for requirements of subparts D through H of introductory text and (c)(2) to read as those materials and uses that these this part when performing the same follows:

individuals performed on or before medical uses. A physician, dentist, or podiatrist, who used only accelerator- §35.190 Training for uptake, dilution, and October 24, 2005, as follows: excretion studies.

(i) For uses authorized under § 35.100 produced radioactive materials, discrete sources of radium-226, or both, for or § 35.200, or oral administration of (a) Is certified by a medical specialty medical uses at the locations and time sodium iodide 1-131 requiring a written board whose certification process has period identified in this paragraph, directive for imaging and localization been recognized by the Commission or qualifies as an authorized user for those purposes, a physician who was certified an Agreement State. The names of board materials and uses performed before on or before October 24, 2005, in certifications that have been recognized these dates, for the purposes of this nuclear medicine by the American by the Commission or an Agreement chapter.

Board of Nuclear Medicine; diagnostic * * * *

• State are posted on the NRC's Medical radiology by the American Board of Uses Licensee Toolkit web page. To Radiology; diagnostic radiology or

• 19. Revise § 35.65 to read as follows: have its certification process recognized, radiology by the American Osteopathic §35.65 Authorization for calibration, a specialty board shall require all Board of Radiology; nuclear medicine transmission, and reference sources. candidates for certification to:

by the Royal College of Physicians and (a) Any person authorized by § 35.11 Surgeons of Canada; or American for medical use of byproduct material (c) * *

• Osteopathic Board of Nuclear Medicine may receive, possess, and use any of the (2) Has obtained written attestation in nuclear medicine; following byproduct material for check, that the individual has satisfactorily (ii) For uses authorized under calibration, transmission, and reference completed the requirements in

§ 35.300, a physician who was certified use: paragraph (c)(1) of this section and is on or before October 24, 2005, by the (1) Sealed sources, not exceeding 1.11 able to independently fulfill the American Board of Nuclear Medicine; GBq (30 mCi) each, manufactured and radiation safety-related duties as an the American Board of Radiology in distributed by a person licensed under authorized user for the medical uses radiology, therapeutic radiology, or § 32.74 of this chapter or equivalent authorized under § 35.100. The radiation oncology; nuclear medicine by Agreement State regulations; attestation must be obtained from either:

the Royal College of Physicians and (2) Sealed sources, not exceeding 1.11 (i) A preceptor authorized user who Surgeons of Canada; or the American GBq (30 mCi) each, redistributed by a meets the requirements in § 35.57, Osteopathic Board of Radiology after licensee authorized to redistribute the § 35.190, § 35.290, or § 35.390, or 1984; sealed sources manufactured and equivalent Agreement State (iii) For uses authorized under distributed by a person licensed under requirements; or

§ 35.400 or § 35.600, a physician who § 32.74 of this chapter or equivalent (ii) A residency program director who was certified on or before October 24, Agreement State regulations, providing affirms in writing that the attestation 2005, in radiology, therapeutic the redistributed sealed sources are in represents the consensus of the radiology or radiation oncology by the the original packaging and shielding residency program faculty where at least American Board of Radiology; radiation and are accompanied by the one faculty member is an authorized oncology by the American Osteopathic manufacturer's approved instructions; user who meets the requirements in Board of Radiology; radiology, with (3) Any byproduct material with a § 35.57, § 35.190, § 35.290, or § 35.390, specialization in radiotherapy, as a half-life not longer than 120 days in or equivalent Agreement State British "Fellow of the Faculty of individual amounts not to exceed 0.56 requirements, and concurs with the Radiology" or "Fellow of the Royal GBq (15 mCi); attestation provided by the residency College of Radiology"; or therapeutic (4) Any byproduct material with a program director. The residency training radiology by the Canadian Royal College half-life longer than 120 days in program must be approved by the of Physicians and Surgeons; and individual amounts not to exceed the Residency Review Committee of the

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33107 Accreditation Council for Graduate authorized user for the medical uses research subjects from the three Medical Education or the Royal College authorized under §§ 35.100 and 35.200. categories in this paragraph. Radioactive of Physicians and Surgeons of Canada or The attestation must be obtained from drugs containing radionuclides in the Council on Postdoctoral Training of either: categories not included in this the American Osteopathic Association (i) A preceptor authorized user who paragraph are regulated under and must include training and meets the requirements in § 35.57, § 35.1000. This work experience must experience specified in paragraph (c)(1) § 35.290, or §§ 35.390 and involve a minimum of three cases in of this section. 35.290(c)(1)(ii)(G), or equivalent each of the following categories for

• 21. In § 35.204, revise paragraph (b) Agreement State requirements; or which the individual is requesting and add paragraph (e) to read as follows: (ii) A residency program director who authorized user status-affirms in writing that the attestation (1) Oral administration of less than or

§35.204 Permissible molybdenum-99, represents the consensus of the equal to 1.22 gigabecquerels (33 strontium-82, and strontium-85 residency program faculty where at least millicuries) of sodium iodide 1-131, for concentrations. one faculty member is an authorized which a written directive is required; user who meets the requirements in (2) Oral administration of greater than (b) A licensee that uses molybdenum- § 35.57, § 35.290, or §§ 35.390 and 1.22 gigabecquerels (33 millicuries) of 99/technetium-99m generators for 35.290(c)(1)(ii)(G), or equivalent sodium iodide 1-131; 2 preparing a technetium-99m Agreement State requirements, and (3) Parenteral administration of any radiopharmaceutical shall measure the concurs with the attestation provided by radioactive drug that contains a molybdenum-99 concentration in each the residency program director. The radionuclide that is primarily used for eluate from a generator to demonstrate residency training program must be its electron emission, beta radiation compliance with paragraph (a) of this approved by the Residency Review characteristics, alpha radiation section. Committee of the Accreditation Council characteristics, or photon energy of less for Graduate Medical Education or the than 150 keV, for which a written (e) The licensee shall report any Royal College of Physicians and directive is required; and measurement that exceeds the limits in Surgeons of Canada or the Council on (2) Has obtained written attestation paragraph (a) of this section at the time Postdoctoral Training of the American that the individual has satisfactorily of generator elution, in accordance with Osteopathic Association and must completed the requirements in

§ 35.3204. include training and experience paragraph (b)(1) of this section and is

• 22. In § 35.290, revise paragraphs (a) specified in paragraph (c)(1) of this able to independently fulfill the introductory text, (c)(1)(ii) introductory section. radiation safety-related duties as an text, and (c)(2) to read as follows:

• 23. In § 35.300, revise the introductory authorized user for the medical uses text to read as follows: authorized under § 35.300 for which the

§35.290 Training for imaging and individual is requesting authorized user localization studies. §35.300 Use of unsealed byproduct status. The attestation must be obtained material for which a written directive is from either:

required. (i) A preceptor authorized user who (a) Is certified by a medical specialty board whose certification process has A licensee may use any unsealed meets the requirements in § 35.57, been recognized by the Commission or byproduct material identified in § 35.390, or equivalent Agreement State an Agreement State. The names of board § 35.390(b)(1)(ii)(G) prepared for requirements and has experience in certifications that have been recognized medical use and for which a written administering dosages in the same by the Commission or an Agreement directive is required that is- dosage category or categories as the State are posted on the NRC's Medical individual requesting authorized user Uses Licensee Toolkit web page. To

• 24. In § 35.390, revise paragraphs (a) status; or have its certification process recognized, introductory text, (b)(1)(ii)(G), and (b)(2) (ii) A residency program director who a specialty board shall require all to read as follows: affirms in writing that the attestation candidates for certification to: represents the consensus of the

§35.390 Training for use of unsealed residency program faculty where at least byproduct material for which a written one faculty member is an authorized (c)(1) * *

• directive is required.

(ii) Work experience, under the user who meets the requirements in supervision of an authorized user who § 35.57, § 35.390, or equivalent (a) Is certified by a medical specialty Agreement State requirements, has meets the requirements in § 35.57, board whose certification process has

§ 35.290, or §§ 35.390 and experience in administering dosages in been recognized by the Commission or the same dosage category or categories 35.290(c)(1)(ii)(G), or equivalent an Agreement State and who meets the Agreement State requirements. An as the individual requesting authorized requirements in paragraphs (b)(1)(ii)(G) user status, and concurs with the authorized nuclear pharmacist who of this section. The names of board meets the requirements in § 35.55 or attestation provided by the residency certifications that have been recognized program director. The residency training

§ 35.57 may provide the supervised by the Commission or an Agreement work experience for paragraph program must be approved by the State are posted on the NRC's Medical Residency Review Committee of the (c)(1)(ii)(G) of this section. Work Uses Licensee Toolkit web page. To be experience must involve- Accreditation Council for Graduate recognized, a specialty board shall Medical Education or the Royal College require all candidates for certification of Physicians and Surgeons of Canada or (2) Has obtained written attestation to: the Council on Postdoctoral Training of that the individual has satisfactorily the American Osteopathic Association completed the requirements in (b)(1) * *

• paragraph (c)(1) of this section and is (ii) * *

• 2 Experience with at least three cases in Category able to independently fulfill the (G) Administering dosages of (G)(2) also satisfies the requirement in Category radiation safety-related duties as an radioactive drugs to patients or human (G)(1).

33108 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations and must include training and

• 26. In § 35.394, revise paragraphs (a) for the parenteral administration experience specified in paragraph (b)(1) and (c)(3) to read as follows: requiring a written directive, to be a of this section. physician who-

§35.394 Training for the oral (1) Is an authorized user under administration of sodium iodide 1-131

• 25. In § 35.392, revise paragraphs (a) § 35.390 for uses listed in requiring a written directive in quantities and (c)(3) to read as follows: greater than 1.22 gigabecquerels (33 § 35.390(b)(1)(ii)(G)(3), or equivalent millicuries). Agreement State requirements; or

§35.392 Training for the oral (2) Is an authorized user under administration of sodium iodide 1-131 § 35.490, § 35.690, or equivalent requiring a written directive in quantities (a) Is certified by a medical specialty board whose certification process Agreement State requirements, and who less than or equal to 1.22 gigabecquerels meets the requirements in paragraph (b)

(33 millicuries). includes all of the requirements in of this section; or paragraphs (c)(1) and (2) of this section, (3) Is certified by a medical specialty (a) Is certified by a medical specialty and whose certification has been board whose certification process has board whose certification process recognized by the Commission or an been recognized by the Commission or includes all of the requirements in Agreement State. The names of board an Agreement State under § 35.490 or paragraphs (c)(1) and (2) of this section certifications that have been recognized

§ 35.690, and who meets the and whose certification process has by the Commission or an Agreement requirements in paragraph (b) of this been recognized by the Commission or State are posted on the NRC's Medical section.

an Agreement State. The names of board Uses Licensee Toolkit web page; or (b) The physician-certifications that have been recognized (1) Has successfully completed 80 by the Commission or an Agreement (c) * *

• hours of classroom and laboratory State are posted on the NRC's Medical (3) Has obtained written attestation training, applicable to parenteral Uses Licensee Toolkit web page; or that the individual has satisfactorily administrations listed in completed the requirements in § 35.390(b)(1)(ii)(G)(3). The training (c) * *

• paragraphs (c)(1) and (2) of this section, must include-(3) Has obtained written attestation and is able to independently fulfill the (i) Radiation physics and that the individual has satisfactorily radiation safety-related duties as an instrumentation; completed the requirements in authorized user for oral administration (ii) Radiation protection; paragraphs (c)(1) and (2) of this section, of greater than 1.22 gigabecquerels (33 (iii) Mathematics pertaining to the use and is able to independently fulfill the millicuries) of sodium iodide 1-131 for and measurement of radioactivity; radiation safety-related duties as an medical uses authorized under § 35.300. (iv) Chemistry of byproduct material authorized user for oral administration The attestation must be obtained from for medical use; and of less than or equal to 1.22 either: (v) Radiation biology; and (i) A preceptor authorized user who (2) Has work experience, under the gigabecquerels (33 millicuries) of meets the requirements in § 35.57, supervision of an authorized user who sodium iodide 1-131 for medical uses

§ 35.390, § 35.394, or equivalent meets the requirements in § 35.57, authorized under § 35.300. The Agreement State requirements, and has § 35.390, § 35.396, or equivalent attestation must be obtained from either:

(i) A preceptor authorized user who experience in administering dosages as Agreement State requirements, in the meets the requirements in § 35.57, specified in § 35.390(b)(1)(ii)(G)(2); or parenteral administrations listed in (ii) A residency program director who § 35.390(b)(1)(ii)(G)(3). A supervising

§ 35.390, § 35.392, § 35.394, or affirms in writing that the attestation authorized user who meets the equivalent Agreement State represents the consensus of the requirements in § 35.390, § 35.396, or requirements and has experience in residency program faculty where at least equivalent Agreement State administering dosages as specified in one faculty member is an authorized requirements, must have experience in

§ 35.390(b)(1)(ii)(G)(1) or (2); or (ii) A residency program director who user who meets the requirements in administering dosages in the same affirms in writing that the attestation § 35.57, § 35.390, § 35.394, or equivalent category or categories as the individual represents the consensus of the Agreement State requirements, has requesting authorized user status. The experience in administering dosages as work experience must involve-residency program faculty where at least specified in § 35.390(b)(1)(ii)(G)(2), and (i) Ordering, receiving, and unpacking one faculty member is an authorized concurs with the attestation provided by radioactive materials safely, and user who meets the requirements in the residency program director. The performing the related radiation

§ 35.57, § 35.390, § 35.392, § 35.394, or surveys; residency training program must be equivalent Agreement State (ii) Performing quality control approved by the Residency Review requirements, has experience in procedures on instruments used to Committee of the Accreditation Council administering dosages as specified in determine the activity of dosages, and for Graduate Medical Education or the

§ 35.390(b)(1)(ii)(G)(1) or (2), and performing checks for proper operation Royal College of Physicians and concurs with the attestation provided by of survey meters; Surgeons of Canada or the Council on the residency program director. The (iii) Calculating, measuring, and Postdoctoral Training of the American residency training program must be safely preparing patient or human Osteopathic Association and must approved by the Residency Review include training and experience research subject dosages; Committee of the Accreditation Council specified in paragraphs (c)(1) and (2) of (iv) Using administrative controls to for Graduate Medical Education or the this section. prevent a medical event involving the Royal College of Physicians and use of unsealed byproduct material;

• 27. Revise § 35.396 to read as follows:

Surgeons of Canada or the Council on (v) Using procedures to contain Postdoctoral Training of the American §35.396 Training for the parenteral spilled byproduct material safely, and Osteopathic Association and must administration of unsealed byproduct using proper decontamination include training and experience material requiring a written directive. procedures; and specified in paragraphs (c)(1) and (2) of (a) Except as provided in § 35.57, the (vi) Administering dosages to patients this section. licensee shall require an authorized user or human research subjects, that include

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33109 at least three cases of the parenteral Exemption (IDE) application accepted

• 30. In § 35.490, revise paragraphs (a) administrations as specified in by the U.S. Food and Drug introductory text, (b)(1)(ii) introductory

§ 35.390(b)(1)(ii)(G)(3); and Administration provided the text, and (b)(3) to read as follows:

(3) Has obtained written attestation requirements of § 35.49(a) are met.

that the individual has satisfactorily §35.490 Training for use of manual

• 29. Revise § 35.433 to read as follows: brachytherapy sources.

completed the requirements in paragraphs (b)(1) and (2) of this section, §35.433 Strontium-90 sources for and is able to independently fulfill the ophthalmic treatments. (a) Is certified by a medical specialty radiation safety-related duties as an (a) Licensees who use strontium-90 board whose certification process has authorized user for the parenteral for ophthalmic treatments must ensure been recognized by the Commission or administration of unsealed byproduct that certain activities as specified in an Agreement State. The names of board material requiring a written directive. paragraph (b) of this section are certifications that have been recognized The attestation must be obtained from performed by either: by the Commission or an Agreement either: (1) An authorized medical physicist; State are posted on the NRC's Medical (i) A preceptor authorized user who or Uses Licensee Toolkit web page. To meets the requirements in § 35.57, (2) An individual who: have its certification process recognized,

§ 35.390, § 35.396, or equivalent (i) is identified as an ophthalmic a specialty board shall require all Agreement State requirements. A physicist on a specific medical use candidates for certification to:

preceptor authorized user who meets license issued by the Commission or an the requirements in § 35.390, § 35.396, Agreement State; permit issued by a or equivalent Agreement State Commission or Agreement State broad (b)1) * *

• requirements, must have experience in scope medical use licensee; medical use (ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, administering dosages in the same permit issued by a Commission master under the supervision of an authorized category or categories as the individual material licensee; or permit issued by a user who meets the requirements in requesting authorized user status; or Commission master material licensee § 35.57, § 35.490, or equivalent (ii) A residency program director who broad scope medical use permittee; and Agreement State requirements, at a affirms in writing that the attestation (ii) holds a master's or doctor's degree medical facility authorized to use represents the consensus of the in physics, medical physics, other byproduct materials under § 35.400, residency program faculty where at least physical sciences, engineering, or involving-one faculty member is an authorized applied mathematics from an accredited * *

• user who meets the requirements in college or university; and (iii) has successfully completed 1 year (3) Has obtained written attestation

§ 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements, has of full-time training in medical physics that the individual has satisfactorily and an additional year of full-time work completed the requirements in experience in administering dosages in experience under the supervision of a paragraphs (b)(1) and (2) of this section the same dosage category or categories as the individual requesting authorized medical physicist; and and is able to independently fulfill the (iv) Has documented training in: radiation safety-related duties as an user status, and concurs with the (A) The creation, modification, and authorized user of manual attestation provided by the residency program director. The residency training completion of written directives; brachytherapy sources for the medical (B) Procedures for administrations uses authorized under § 35.400. The program must be approved by the requiring a written directive; and attestation must be obtained from either:

Residency Review Committee of the Accreditation Council for Graduate (C) Performing the calibration (i) A preceptor authorized user who Medical Education or the Royal College measurements of brachytherapy sources meets the requirements in § 35.57, of Physicians and Surgeons of Canada or as detailed in § 35.432. § 35.490, or equivalent Agreement State the Council on Postdoctoral Training of (b) The individuals who are identified requirements; or the American Osteopathic Association in paragraph (a) of this section must: (ii) A residency program director who and must include training and (1) Calculate the activity of each affirms in writing that the attestation experience specified in paragraphs strontium-90 source that is used to represents the consensus of the (b)(1) and (2) of this section. determine the treatment times for residency program faculty where at least ophthalmic treatments. The decay must one faculty member is an authorized

• 28. Revise § 35.400 to read as follows:

be based on the activity determined user who meets the requirements in

§35.400 Use of sources for manual under § 35.432; and

§ 35.57, § 35.490, or equivalent brachytherapy. (2) Assist the licensee in developing, Agreement State requirements, and A licensee must use only implementing, and maintaining written concurs with the attestation provided by brachytherapy sources: procedures to provide high confidence the residency program director. The (a) Approved in the Sealed Source that the administration is in accordance residency training program must be and Device Registry for manual with the written directive. These approved by the Residency Review brachytherapy medical use. The manual procedures must include the Committee of the Accreditation Council brachytherapy sources may be used for frequencies that the individual meeting for Graduate Medical Education or the manual brachytherapy uses that are not the requirements in paragraph (a) of this Royal College of Physicians and explicitly listed in the Sealed Source section will observe treatments, review Surgeons of Canada or the Council on and Device Registry, but must be used the treatment methodology, calculate Postdoctoral Training of the American in accordance with the radiation safety treatment time for the prescribed dose, Osteopathic Association and must conditions and limitations described in and review records to verify that the include training and experience the Sealed Source and Device Registry; administrations were in accordance specified in paragraphs (b)(1) and (2) of or with the written directives. this section.

(b) In research to deliver therapeutic (c) Licensees must retain a record of doses for medical use in accordance the activity of each strontium-90 source

• 31. In § 35.491, revise paragraph (b)(3) with an active Investigational Device in accordance with § 35.2433. to read as follows:

33110 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations

§35.491 Training for ophthalmic use of been recognized by the Commission or (d)(1) Prior to the first use for patient strontium-90. an Agreement State are posted on the treatment of a new unit or an existing NRC's Medical Uses Licensee Toolkit unit with a manufacturer upgrade that (b)* *

• web page; or affects the operation and safety of the (3) Has obtained written attestation, (b) Is an authorized user for uses unit, a licensee shall ensure that vendor signed by a preceptor authorized user listed in § 35.200 or equivalent operational and safety training is who meets the requirements in § 35.57, Agreement State requirements; or provided to all individuals who will

§ 35.490, § 35.491, or equivalent (c) Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of operate the unit. The vendor operational Agreement State requirements, that the classroom and laboratory training in and safety training must be provided by individual has satisfactorily completed basic radionuclide handling techniques the device manufacturer or by an the requirements in paragraphs (b)(1) specifically applicable to the use of the individual certified by the device and (2) of this section and is able to device. The training must include- manufacturer to provide the operational independently fulfill the radiation (1) Radiation physics and and safety training.

safety-related duties as an authorized instrumentation; (2) A licensee shall provide user of strontium-90 for ophthalmic use. (2) Radiation protection; operational and safety instructions (3) Mathematics pertaining to the use initially and at least annually to all

• 32. Revise § 35.500 to read as follows:

and measurement of radioactivity; and individuals who operate the unit at the

§35.500 Use of sealed sources and (4) Radiation biology; and facility, as appropriate to the medical devices for diagnosis. (d) Has completed training in the use individual's assigned duties. The (a) A licensee must use only sealed of the device for the uses requested.

instructions shall include instruction sources that are not in medical devices

• 34. Revise § 35.600 to read as follows: in-for diagnostic medical uses if the sealed (i) The procedures identified in

§ 35.600 Use of a sealed source in a sources are approved in the Sealed paragraph (a)(4) of this section; and remote afterloader unit, teletherapy unit, or Source and Device Registry for gamma stereotactic radiosurgery unit. (ii) The operating procedures for the diagnostic medicine. The sealed sources unit.

(a) A licensee must only use sealed may be used for diagnostic medical uses sources:

that are not explicitly listed in the (1) Approved and as provided for in (g) A licensee shall retain a copy of Sealed Source and Device Registry but the Sealed Source and Device Registry the procedures required by paragraphs must be used in accordance with the in photon emitting remote afterloader (a)(4) and (d)(2)(ii) of this section in radiation safety conditions and units, teletherapy units, or gamma accordance with § 35.2610.

limitations described in the Sealed stereotactic radiosurgery units to deliver

• 36. In § 35.655, revise the section Source and Device Registry. therapeutic doses for medical uses: or heading and paragraph (a) to read as (b) A licensee must only use medical (2) In research involving photon- follows:

devices containing sealed sources for emitting remote afterloader units, diagnostic medical uses if both the teletherapy units, or gamma stereotactic §35.655 Full-inspection servicing for sealed sources and medical devices are teletherapy and gamma stereotactic radiosurgery units in accordance with radiosurgery units.

approved in the Sealed Source and an active Investigational Device Device Registry for diagnostic medical Exemption (IDE) application accepted (a) A licensee shall have each uses. The diagnostic medical devices teletherapy unit and gamma stereotactic by the U.S. Food and Drug may be used for diagnostic medical uses Administration provided the radiosurgery unit fully inspected and that are not explicitly listed in the serviced during each source requirements of § 35.49(a) are met.

Sealed Source and Device Registry but (b) A licensee must use photon- replacement to assure proper must be used in accordance with the emitting remote afterloader units, functioning of the source exposure radiation safety conditions and teletherapy units, or gamma stereotactic mechanism and other safety limitations described in the Sealed radiosurgery units: components. The interval between each Source and Device Registry. (1) Approved in the Sealed Source full-inspection servicing shall not (c) Sealed sources and devices for and Device Registry to deliver a exceed 5 years for each teletherapy unit diagnostic medical uses may be used in therapeutic dose for medical use. These and shall not exceed 7 years for each research in accordance with an active devices may be used for therapeutic gamma stereotactic radiosurgery unit.

Investigational Device Exemption (IDE) medical treatments that are not application accepted by the U.S. Food explicitly provided for in the Sealed

• 37. In § 35.690, revise paragraphs (a) and Drug Administration provided the Source and Device Registry, but must be introductory text, (b)(1)(ii) introductory requirements of § 35.49(a) are met. used in accordance with radiation safety text, and (b)(3) to read as follows:

• 33. Revise § 35.590 to read as follows: conditions and limitations described in the Sealed Source and Device Registry; §35.690 Training for use of remote

§35.590 Training for use of sealed afterloader units, teletherapy units, and sources and medical devices for diagnosis.

or gamma stereotactic radiosurgery units.

(2) In research in accordance with an Except as provided in § 35.57, the active Investigational Device Exemption licensee shall require the authorized (IDE) application accepted by the FDA (a) Is certified by a medical specialty user of a diagnostic sealed source or a provided the requirements of § 35.49(a) board whose certification process has device authorized under § 35.500 to be are met. been recognized by the Commission or a physician, dentist, or podiatrist who- an Agreement State and who meets the

• 35. In § 35.610, revise paragraphs (d)

(a) Is certified by a specialty board requirements in paragraph (c) of this whose certification process includes all and (g) to read as follows: section. The names of board of the requirements in paragraphs (c) §35.610 Safety procedures and certifications that have been recognized and (d) of this section and whose instructions for remote afterloader units, by the Commission or an Agreement certification has been recognized by the teletherapy units, and gamma stereotactic State are posted on the NRC's Medical Commission or an Agreement State. The radiosurgery units. Uses Licensee Toolkit web page. To names of board certifications that have have its certification process recognized,

Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations 33111 a specialty board shall require all license, a copy of the written document material or the wrong radionuclide for candidates for certification to: appointing the Associate Radiation a brachytherapy procedure; Safety Officer signed by the licensee's (B) An administration of a radioactive (b)(1) * *

• management. drug containing byproduct material by (ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience,

• 39. Revise § 35.2310 to read as the wrong route of administration; under the supervision of an authorized follows: (C) An administration of a dose or user who meets the requirements in dosage to the wrong individual or

§ 35.57, § 35.690, or equivalent § 35.2310 Records of safety instruction. human research subject; Agreement State requirements, at a A licensee shall maintain a record of (D) An administration of a dose or medical facility that is authorized to use safety instructions required by §§ 35.310 dosage delivered by the wrong mode of byproduct materials in § 35.600, and 35.410 and the operational and treatment; or involving- safety instructions required by § 35.610 (E) A leaking sealed source.

for 3 years. The record must include a (iii) A dose to the skin or an organ or list of the topics covered, the date of the tissue other than the treatment site that (3) Has obtained written attestation instruction, the name(s) of the exceeds by:

that the individual has satisfactorily (A) 0.5 Sv (50 rem) or more the completed the requirements in attendee(s), and the name(s) of the individual(s) who provided the expected dose to that site from the paragraphs (b)(1) and (2) and (c) of this procedure if the administration had section; and is able to independently instruction.

been given in accordance with the fulfill the radiation safety-related duties

• 40. In § 35.2655, revise the section written directive prepared or revised as an authorized user of each type of heading and paragraph (a) to read as before administration; and therapeutic medical unit for which the follows: (B) 50 percent or more the expected individual is requesting authorized user dose to that site from the procedure if status. The attestation must be obtained §35.2655 Records of full-inspection servicing for teletherapy and gamma the administration had been given in from either: stereotactic radiosurgery units. accordance with the written directive (i) A preceptor authorized user who prepared or revised before meets the requirements in § 35.57, (a) A licensee shall maintain a record of the full-inspection servicing for administration.

§ 35.690, or equivalent Agreement State (2) For permanent implant requirements for the type(s) of teletherapy and gamma stereotactic radiosurgery units required by § 35.655 brachytherapy, the administration of therapeutic medical unit for which the byproduct material or radiation from individual is requesting authorized user for the duration of the use of the unit.

byproduct material (excluding sources status; or that were implanted in the correct site (ii) A residency program director who

• 41. In § 35.3045, revise paragraph (a) but migrated outside the treatment site) affirms in writing that the attestation to read as follows: that results in-represents the consensus of the (i) The total source strength residency program faculty where at least §35.3045 Report and notification of a medical event. administered differing by 20 percent or one faculty member is an authorized more from the total source strength user who meets the requirements in (a) A licensee shall report any event documented in the post-implantation

§ 35.57, § 35.690, or equivalent as a medical event, except for an event portion of the written directive; Agreement State requirements, for the that results from patient intervention, in (ii) The total source strength type(s) of therapeutic medical unit for which-administered outside of the treatment which the individual is requesting (1) The administration of byproduct site exceeding 20 percent of the total authorized user status, and concurs with material or radiation from byproduct source strength documented in the post-the attestation provided by the material, except permanent implant implantation portion of the written residency program director. The brachytherapy, results in-directive; or residency training program must be (i) A dose that differs from the (iii) An administration that includes approved by the Residency Review prescribed dose or dose that would have any of the following:

Committee of the Accreditation Council resulted from the prescribed dosage by (A) The wrong radionuclide; for Graduate Medical Education or the more than 0.05 Sv (5 rem) effective dose (B) The wrong individual or human Royal College of Physicians and equivalent, 0.5 Sv (50 rem) to an organ research subject; Surgeons of Canada or the Council on or tissue, or 0.5 Sv (50 rem) shallow (C) Sealed source(s) implanted Postdoctoral Training of the American dose equivalent to the skin; and directly into a location discontiguous Osteopathic Association and must (A) The total dose delivered differs from the treatment site, as documented include training and experience from the prescribed dose by 20 percent in the post-implantation portion of the specified in paragraphs (b)(1) and (2) of or more; written directive; or this section. (B) The total dosage delivered differs (D) A leaking sealed source resulting from the prescribed dosage by 20 in a dose that exceeds 0.5 Sv (50 rem) percent or more or falls outside the to an organ or tissue.

• 38. In § 35.2024, add paragraph (c) to prescribed dosage range; or read as follows:

(C) The fractionated dose delivered

§35.2024 Records of authority and differs from the prescribed dose for a

• 42. Add § 35.3204 to subpart M to responsibilities for radiation protection single fraction, by 50 percent or more. read as follows:

programs. (ii) A dose that exceeds 0.05 Sv (5 §35.3204 Report and notification for an rem) effective dose equivalent, 0.5 Sv eluate exceeding permissible molybdenum-(c) For each Associate Radiation (50 rem) to an organ or tissue, or 0.5 Sv 99, strontium-82, and strontium-85 Safety Officer appointed under (50 rem) shallow dose equivalent to the concentrations.

§ 35.24(b), the licensee shall retain, for skin from any of the following- (a) The licensee shall notify by 5 years after the Associate Radiation (A) An administration of a wrong telephone the NRC Operations Center Safety Officer is removed from the radioactive drug containing byproduct and the distributor of the generator

33112 Federal Register/Vol. 83, No. 136/Monday, July 16, 2018/Rules and Regulations within 7 calendar days after discovery shall submit a written report to the the licensee's equipment, procedures or that an eluate exceeded the permissible appropriate NRC Regional Office listed training that contributed to the concentration listed in § 35.204(a) at the in § 30.6 of this chapter within 30 excessive readings if an error occurred time of generator elution. The telephone calendar days after discovery of an in the licensee's breakthrough report to the NRC must include the eluate exceeding the permissible determination; and the information in manufacturer, model number, and serial concentration at the time of generator the telephone report as required by number (or lot number) of the generator; elution. The written report must include paragraph (a) of this section.

the results of the measurement; the date the action taken by the licensee; the Dated at Rockville, Maryland, this 6th day of the measurement; whether dosages patient dose assessment; the of July 2018.

were administered to patients or human methodology used to make this dose For the Nuclear Regulatory Commission.

research subjects, when the distributor assessment if the eluate was Russell E. Chazell, was notified, and the action taken. administered to patients or human Acting Secretry of the Commission.

(b) By an appropriate method listed in research subjects; and the probable [FR Doe. 2018-14852 Filed 7-13-18; 8:45 am]

§ 30.6(a) of this chapter, the licensee cause and an assessment of failure in BILLING CODE 7590-01-P