ML22125A247

Evaluation of NRC Recognized Specialty Boards

ML22125A247
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Issue date:	07/31/2022
From:	Jennifer Fisher NRC/NMSS/DMSST/MSEB
To:	NRC/OCM
Fisher J
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ML22125A241	List: ML22125A247
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Evaluation of NRC-Recognized Specialty Boards U.S. Nuclear Regulatory Commission July 2022 ML22125A247

I. Introduction The U.S. Nuclear Regulatory Commission (NRC) conducted an evaluation of specialty boards that had previously been recognized by the NRC. This evaluation determined whether each specialty board continues to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material. The evaluation addresses the request in the Staff Requirements Memorandum, Staff Requirements - SECY-20-0005 -

Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR PART 35), dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22027A519). The staff determined that 9 of the 11 recognized specialty boards continue to meet the criteria in 10 CFR Part 35 and that two specialty boards have become inactive. In addition, the American Board of Radiology (ABR) has informed the NRC staff that it plans to eliminate its NRC-recognized certification processes by the end of 2023, effectively ending the NRCs recognition of its program.

II. Background On August 13, 1998 (63 FR 43516), the NRC published a proposed revision of the Medical Use of Byproduct Material, which included training and experience regulations. The discussion summarized workshops held for stakeholders within the medical community to discuss the range of options for a physician to become an authorized user. The options included possessing a medical degree, medical specialty certifications, examinations, approved training programs, and a set number of training hours. The final rule to 10 CFR Part 35 was published on April 24, 2002 (67 FR 20249). In this final rule and in addition to the alternate pathway, a physician may become an authorized user if certified by a medical or specialty board whose certification process is recognized by the Commission.

The staff requirements memorandum (SRM) associated with SECY-02-0194, dated February 12, 2003 (ML030440087), instructed the staff to prepare a proposed rule to modify the training and experience requirements. The SRM also stated that, because of the important role of specialty board certification, a clear regulatory determination for all specialty boards, both new and existing, on whether each board met the revised criteria would be required.

The SRM associated with SECY-03-0145, dated October 9, 2003 (ML032820570), instructed the staff to: (1) implement procedures both for adding new specialty boards to the recognized listing and for removing boards from the recognized list; (2) list the boards meeting the criteria on the NRCs website (Medical Uses Licensee Toolkit); and (3) implement procedures to evaluate whether a medical event may have been due to inadequate radiation safety training.

On March 30, 2005 (70 FR 16335), the NRC published the final rule, 10 CFR Part 35 - Medical Use of Byproduct Material Recognition of Specialty Boards, providing, among other things, the updated criteria that specialty boards must meet to be recognized by the NRC or the Agreement States. Once a specialty boards certification process for a specialty area is recognized by the NRC, any individual certified by that specialty board for the recognized specialty area may be approved to be an authorized user, radiation safety officer (RSO) or associate RSO, authorized medical physicist, or authorized nuclear pharmacist. The NRC license reviewers grant these approvals during licensing actions.

The staff maintains an NRC public website titled Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35. The website lists the specialty boards and specialty areas recognized by the NRC, and it provides samples of board certificates to allow NRC and 2

Agreement State license reviewers to compare the sample certificates to the certificates submitted as part of a licensing action.

Between 2005 and 2013, the staff reviewed the specialty board applications and granted NRC recognition when appropriate. The staff have not received any new applications in the last nine years; however, the NRC has continued to work with the specialty boards on the recognition of additional specialty areas.

The NRC requests that the specialty boards provide updates when a change in their certification process occurs or if the status of the specialty board changes. The NRC includes this request in each letter sent to the specialty board. The staff works with the specialty boards to ensure that the certificate included on the NRC public website is current. Most communication with the specialty boards has been in response to their outreach or has followed a change in process identified through a revised certificate.

The NRC conducted a self-assessment of its specialty board certification processes, including the implementation of NMSS Office Procedure 70-03, Procedures for Recognizing, Monitoring, and Terminating the Certification Process of Specialty Boards (ML20351A389), on September 9, 2019 (ML19360A085). The self-assessment did not include a maintenance review of the specialty boards recognized by the NRC. In this self-assessment, the NRC staff identified that the staff had not conducted maintenance reviews at the 5 year interval specified by NMSS Office Procedure 70-03. This evaluation is the first time that the 5 year review has been completed.

III. Procedure The staff performed the evaluation using NMSS Office Procedure 70-03, Section 3.11, Monitoring Continued Satisfaction of Recognition Requirements, as indicated below:

• The reviewers should contact each of the specialty boards with a written request that the specialty board confirm that it still satisfies the board recognition criteria, if the specialty board did not submit a notification of change, revised certificate, or any other communication within the last 5 years.

The reviewers should request verification in writing on whether it has changed its name, the name of its specialty certifications, or its certificates. The reviewer should also request that any changes in the boards certification procedures that could affect the recognition status be communicated to the NRC for review. The board does not need to generate any new documents.

The reviewers should create a publicly available ADAMS package with the initial letter and all resulting correspondence.

• The reviewers should evaluate the recognized boards publicly available Web site for changes that could affect the recognition of the boards certification process(es).

• The reviewers should determine if the boards certification program continues to meet the applicable criteria for recognition of board certifications, as established in §§ 35.50(a),

35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a),

35.590(a), and 35.690(a). The reviewers should seek the advice of the ACMUI if necessary.

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The reviewers should notify the board regarding any adverse findings via letter signed by the Division Director.

• The reviewers should verify that the listing of NRC-recognized certifications on the NRC public website is up to date. The reviewers should update the listing, if needed.

IV. Process Confirmation Letters The staff initiated the review by sending each NRC-recognized specialty board a letter on March 15, 2022. In the letter, the staff requested confirmation from each specialty board that

1) they continue to satisfy the NRC recognition criteria for specialty board certification processes; 2) there had not been changes in the boards certification procedures that could affect the recognition status; and 3) that the certificates provided were current.

The NRC sent the most recent version of the boards certificate as an enclosure to each confirmation letter. The confirmation letter asked each specialty board to confirm that the certificate was current or to submit the newest version. The NRC requested that the specialty board respond within 30 days of the date of the letter.

Methodology The staff reviewed each specialty boards response letter to determine whether the specialty board continued to meet the NRC recognition criteria. The staff compared any changes in the specialty boards processes, as provided in the response letter, to the NRC regulations to determine whether the changes could affect the recognition of the boards certification processes. In addition to reviewing the response letter and supporting documentation, the staff reviewed applicable sections of the recognized boards public website to determine whether the boards certification processestraining and experience, eligibility, and examination topicsare consistent with NRC requirements.

If the staff still had questions after reviewing the website, the response letter, and any other documentation provided, then the staff contacted the specialty board for additional information.

If needed, the specialty board provided additional documentation, such as examination study guides or scientific paper study references, which helped the staff to ensure compliance.

The staff also reviewed the certificates provided by each of the specialty boards. The staff evaluated each certificate to ensure that the specialty boards name and specialty area were clearly marked on each one. The staff considered special marks or notations that were present.

The staff also verified and confirmed the effective dates for each certificate. The staff degraded the image and ensured that a Not Valid watermark was present prior to adding the certificate to ADAMS as publicly available and uploading it to the NRC public website. The NRC public website displays degraded images to reduce the opportunity for fraudulent manipulation. NRC staff have access to the original certificates if needed through non-public ADAMS.

Communication Logs Communication between the staff and specialty boards was accomplished through letters, emails, and the telephone. The communication log for each specialty board was added to ADAMS as publicly available.

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V. Evaluation The staff evaluated the specialty boards that had been previously recognized by the NRC, as summarized in Table 1. The staff compared each specialty boards certification process for each NRC-recognized specialty area to the NRC requirements that the specialty board had committed to.

The staff received 10 response letters that confirmed that the specialty boards confirmation processes complied with NRC requirements during active certification timeframes. The American Osteopathic Board of Nuclear Medicine (AOBNM) confirmed that the specialty boards confirmation process had complied with NRC requirements but noted that they had become inactive. The staff were unable to evaluate the Certification Board of Nuclear Endocrinology (CBNE) since there was no response to NRC inquiries.

Of the 10 specialty boards that replied, nine provided new certificates and one confirmed that the certificate maintained on the NRC website was current.

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Table 1. The staff analysis for each specialty boards NRC-recognized specialty area.

A green check means that the NRC-recognized specialty board continues or continued to satisfy the board recognition criteria.

A red x means that the NRC staff were unable to conclude that the specialty board satisfied the board recognition criteria.

Specialty CFR Section Position NRC Staff Analysis Areas

1. American Board of Health Physics (ABHP)

Health Physics 10 CFR 35.50, Radiation The staff reviewed the ABHP Prospectus and determined that the program met the Training for Safety Officer training and eligibility requirements in 10 CFR 35.50(a)(1)(i) and (ii). The staff reviewed Radiation Safety (RSO) and the content on the ABHP website, including Section 4 - Examination Topics - Role Officer and Associate RSO Delineation, and Section 7 - Suggested Study References, and determined that the ABHP Associate Radiation examination included the safety-significant topics laid out in 10 CFR 35.50(a)(1)(iii).

Safety Officer.

The staff reviewed the two certificates provided: 1) ABHP Health Physics certificate effective from January 1, 2005, to December 31, 2017, and 2) ABHP Health Physics certificate effective on January 1, 2018. The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the ABHP certification process for the Health Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.50.

2. American Board of Medical Physics (ABMP)

Medical Health 10 CFR 35.50 RSO and The staff reviewed the eligibility requirements and the professional experience Physics Associate RSO requirements sections of the ABMP Information Booklet, last revised in January 2019. The staff confirmed that the eligibility and professional experience that the ABMP requires as part of their program is in compliance with 10 CFR 35.50(a)(2)(i) and (ii).

The staff reviewed the Examination Content Outline provided on the ABMP website and determined that nuclear medicine physics and radiation safety topics were included in the examination. The examination content is in compliance with 10 CFR 35.50(a)(2)(iii).

The staff reviewed the new ABMP Medical Health Physics certificate provided, effective on January 1, 2017. The staff updated the NRC public website.

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Based on the response letter and the NRCs subsequent review, the ABMP certification process for the Medical Health Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.50.

3. American Board of Nuclear Medicine (ABNM)

Nuclear 10 CFR 35.190, Authorized User The staff reviewed the ABNM response letter and subsequent responses to a request for Medicine Training for uptake, additional information and received confirmation that there were no major changes to the dilution, and board (name, certificates, criteria) and its certification process that could affect their excretion studies. recognition status.

10 CFR 35.290, The staff reviewed the ABNM public website, including the Certification Training Training for Requirements, NRC Compliance, and Exam Content Manual and Study Guide. The staff imaging and compared the ABNM criteria for certification in these references to the NRC regulations localization studies. and verified that the training and experience requirements met the regulatory requirements in 10 CFR 35.190, 35.290, and 35.390.

10 CFR 35.390, Training for use of The staff reviewed the four ABNM Nuclear Medicine certificates provided: 1) effective from unsealed byproduct October 28, 2005, to October 11, 2007; 2) effective from October 12, 2017, to October 6, material for which a 2011; 3) effective from October 7, 2011, to October 4, 2012; and 4) effective on October written directive is 5, 2012. The staff updated the NRC public website.

required.

Based on the response letter and the NRCs subsequent review, the ABNM certification process for the Nuclear Medicine specialty area continues to satisfy the board recognition criteria in 10 CFR 35.190, 35.290, and 35.390.

4. American Board of Radiology1 (ABR)

Diagnostic 10 CFR 35.50 RSO and The staff reviewed the ABR response letter and subsequent responses to request for Medical Physics Associate RSO additional information and received confirmation that there were no major changes to the board (name, certificates, criteria) and its certification process that could affect their recognition status.

The staff reviewed the ABR public website, including the Certification Requirements for Medical Physics, NRC Compliance, and Exam Content Guide and Requirements. The staff compared the ABR criteria for certification in these references to the NRC regulations and verified that the training and experience requirements met the regulatory requirements in 10 CFR 35.50.

1 See discussion, infra, regarding the ABRs intention to terminate NRC recognition by the end of 2023.

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The staff reviewed the four ABR Diagnostic Medical Physics certificates: 1) effective from May 1, 2011, to April 30, 2012; 2) effective from May 1, 2012, to April 30, 2013; 3) effective from May 1, 2013, to April 30, 2019; and 4) effective on May 1, 2019. The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the ABR certification process for the Diagnostic Medical Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.50.

Nuclear Medical 10 CFR 35.50 RSO and The staff reviewed the ABR response letter and subsequent responses to a request for Physics Associate RSO additional information and received confirmation that there were no major changes to the board (name, certificates, criteria) and its certification process that could affect their recognition status.

The staff reviewed the ABR public website, including the Certification Requirements for Medical Physics, NRC Compliance, and Exam Content Guide and Requirements. The staff compared the ABR criteria for certification in these references to the NRC regulations and verified that the training and experience requirements met the regulatory requirements in 10 CFR 35.50.

The staff reviewed the four ABR Nuclear Medical Physics certificates provided:

1) effective from May 1, 2011, to April 30, 2012; 2) effective from May 1, 2012, to April 30, 2013; 3) effective from May 1, 2013, to April 30, 2019; and 4) effective on May 1, 2019.

The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the ABR certification process for the Nuclear Medical Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.50.

Therapeutic 10 CFR 35.51, Authorized The staff reviewed the ABR response letter and subsequent responses to request for Medical Physics Training for an Medical additional information and received confirmation that there were no major changes to the authorized medical Physicist board (name, certificates, criteria) and its certification process that could affect their physicist. recognition status.

The staff reviewed the ABR public website, including the Certification Requirements for Medical Physics, NRC Compliance, and Exam Content Guide and Requirements. The staff compared the ABR criteria for certification in these references to the NRC regulations and verified that the training and experience requirements met the regulatory requirements in 10 CFR 35.51.

The staff reviewed the four certificates provided, ABR Therapeutic Medical Physics Certificates: 1) effective from May 1, 2011, to April 30, 2012; 2) effective from May 1, 8

2012, to April 30, 2013; 3) effective from May 1, 2013, to April 30, 2019; and 4) effective on May 1, 2019. The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the ABR certification process for the Therapeutic Medical Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.50.

Diagnostic 10 CFR 35.290 Authorized User The staff reviewed the ABR response letter and subsequent responses to request for Radiology additional information and received confirmation that there were no major changes to the 10 CFR 35.392, board (name, certificates, criteria) and its certification process that could affect their Training for the oral recognition status.

administration of sodium iodide I-131 The staff reviewed the ABR public website, including the Certification Requirements for requiring a written Diagnostic Radiology, NRC Compliance, and Exam Content Guide and Requirements.

directive in The staff compared the ABR criteria for certification in these references to the NRC quantities less than regulations and verified that the training and experience requirements met the regulatory or equal to 1.22 requirements in 10 CFR 35.290, 35.392, and 35.394.

gigabecquerels (33 millicuries). The ABR confirmed that the certificate on the NRC public website was current.

10 CFR 35.394, Based on the response letter and the NRCs subsequent review, the ABR certification Training for the oral process for the Diagnostic Radiology specialty area continues to satisfy the board administration of recognition criteria in 10 CFR 35.290, 35.392, and 35.394.

sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

Interventional 10 CFR 35.290 Authorized User The staff reviewed the ABR response letter and subsequent responses to request for Radiology / additional information and received confirmation that there were no major changes to the Diagnostic 10 CFR 35.394 board (name, certificates, criteria) and its certification process that could affect their Radiology recognition status.

The staff reviewed the ABR public website for the Certification Requirements for Interventional Radiology / Diagnostic Radiology, NRC Compliance, and Exam Content Guide. The staff compared the ABR criteria for certification in these references to the NRC regulations and verified that the training and experience requirements met the regulatory requirements in 10 CFR 35.290 and 35.394.

The ABR confirmed that the certificate on the NRC public website was current.

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Based on the response letter and the NRCs subsequent review, the ABR certification process for the Interventional Radiology / Diagnostic Radiology specialty area continues to satisfy the board recognition criteria in 10 CFR 35.290 and 35.394.

Radiation 10 CFR 35.390 Authorized User The staff reviewed the ABR response letter and subsequent responses to a request for Oncology additional information and received confirmation that there were no major changes to the 10 CFR 35.490, board (name, certificates, criteria) and its certification process that could affect their Training for use of recognition status.

manual brachytherapy The staff reviewed the ABR public website for the Certification Requirements for Radiation sources. Oncology, NRC Compliance, and Exam Content Guide. The staff compared the ABR criteria for certification in these references to the NRC regulations and verified that the 10 CFR 35.690, training and experience requirements met the regulatory requirements in 10 CFR 35.390, Training for use of 35.490, and 35.690.

remote afterloader units, teletherapy The ABR confirmed that the certificate on the NRC public website was current.

units, and gamma stereotactic Based on the response letter and the NRCs subsequent review, the ABR certification radiosurgery units. process for the Radiation Oncology specialty area continues to satisfy the board recognition criteria in 10 CFR 35.390, 35.490, and 35.690.

5. American Board of Science in Nuclear Medicine (ABSNM)

Nuclear 10 CFR 35.50 RSO and The staff reviewed the ABSNM public website, titled Examinations, Definitions of Specialty Medicine Associate RSO Areas, and verified the training and eligibility requirements met the standard in 10 CFR Physics and 35.50(a)(1) and (a)(2). Two of the four specialty areas, Molecular Imaging and Instrumentation Radiopharmaceutical Science are not NRC-recognized and were outside of the scope of this review.

and The staff reviewed the Nuclear Science Syllabus, fifth edition, Editor Bennett S.

Radiation Greenspan, MD, MS, 2018. This is a nonpublic document that is distributed after the Protection candidates pay their examination fee. The staff determined that the examination content met the standard in 10 CFR 35.50(a)(1)(iii) and 35.50(a)(2)(iii).

The staff reviewed the two certificates provided: 1) ABSNM Radiation Protection certificate, effective on January 1, 2010, and 2) ABSNM Nuclear Medicine Physics and Instrumentation certificate, effective on January 1, 2010. The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the ABSNM certification processes for the Nuclear Medicine Physics and Instrumentation and the Radiation Protection specialty areas continue to satisfy the board recognition criteria in 10 CFR 35.50.

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6. American Osteopathic Board of Nuclear Medicine (AOBNM)

Nuclear 10 CFR 35.290 Authorized User The staff reviewed the AOBNM response letter and noted that the specialty board had Medicine been inactive since March 5, 2019. AOBNM indicated that an Intent to Terminate letter will be sent to the NRC to start the termination process.

The staff reviewed the AOBNM public website and confirmed that AOBNM required their candidates to have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in nuclear medicine. The staff determined that the training and experience for certification met the requirements of 10 CFR 35.290(c)(1)(I) - (c)(1)(ii)(G).

The staff reviewed the AOBNM public website and documentation provided by the board and determined that AOBNM had met the exam requirements in 10 CFR 35.290(a)(2).

The staff reviewed the two certificates provided: 1) AOBNM Nuclear Medicine certificate, effective from May 12, 2017, to September 19, 2018, and 2) AOBNM Nuclear Medicine certificate, effective from September 20, 2018, to March 5, 2019. The AOBNM Nuclear Medicine Certificate (effective from May 12, 2017, to September 19, 2018) did not include the specialty area clearly printed on the certificate. AOBNM submitted a replacement certificate (ML22153A359), which the staff found to be adequate.

Based on the response letter and the NRCs subsequent review, the AOBNM certification process for the Nuclear Medicine specialty area satisfied the board recognition criteria in 10 CFR 35.290 until the board became inactive on March 5, 2019.

7. American Osteopathic Board of Radiology (AOBR)

Diagnostic 10 CFR 35.290 Authorized User The staff reviewed the AOBR public website titled Diagnostic Radiology Certification Radiology Process and confirmed that AOBR requires their candidates to have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training 10 CFR 35.392 and experience in Nuclear Medicine. The staff also reviewed supporting documentation titled Criteria for AOBR Certification in Diagnostic Radiology, and a preceptor form for 10 CFR 35.394 the administration of oral I-131 and was able to confirm that the program met the training and experience requirements in 10 CFR 35.290, 10 CFR 35.392, and 10 CFR 35.394.

The staff reviewed the AOBR public website titled Diagnostic Radiology Written Exam and supporting documentation titled Diagnostic Radiology Test Blueprint and determined that the program was in compliance with the examination content specified in 10 CFR 35.290(a)(2).

The staff reviewed the two certificates provided: 1) AOBR Diagnostic Radiology certificate, effective from May 12, 2017, to September 19, 2018, and 2) AOBR Diagnostic Radiology certificate, effective on September 20, 2018. The staff updated the NRC public website.

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Based on the response letter and the NRCs subsequent review, the AOBR certification process for the Diagnostic Radiology specialty area continues to satisfy the board recognition criteria in 10 CFR 35.290, 35.392, and 35.394.

Radiation 10 CFR 35.390 Authorized User The staff reviewed the AOBR public website titled Radiation Oncology and supporting Oncology documentation, Criteria for AOBR Certification in Radiation Oncology, and confirmed 10 CFR 35.490 that AOBR required their candidates to have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in Nuclear Medicine. The staff determined that the residency program included 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of 10 CFR 35.690 training and experience as described in 10 CFR 35.390(b)(1)(I) - (b)(1)(ii)(E).

The staff reviewed the AOBR public website titled Radiation Oncology Certification Process and determined that the program was in compliance with the training and experience requirements in 10 CFR 35.490(a)(1) and 10 CFR 35.690(a)(1).

The staff reviewed the AOBR public website, Radiation Oncology Written Exam, as well as supporting documentation titled Radiation Oncology Test Blueprint and determined that the program was in compliance with the examination content specified in 10 CFR 35.390(a)(2), 10 CFR 35.490(a)(2), and 10 CFR 35.690(a)(2).

The staff reviewed the two certificates provided: 1) AOBR Radiation Oncology certificate, effective from May 12, 2017, to September 19, 2018, and 2) AOBR Radiation Oncology certificate, effective on September 20, 2018. The staff updated the NRC public website.

Based on the response letter and the NRCs subsequent review, the AOBR certification process for the Radiation Oncology specialty area continues to satisfy the board recognition criteria in 10 CFR 35.390, 35.490, and 35.690.

8. Board of Pharmacy Specialties (BPS)

Board Certified 10 CFR 35.55, Authorized The staff reviewed the BPS public website, including Examination Content Outlines, Nuclear Training for an Nuclear Nuclear and Eligibility Requirements. The staff reviewed the BPS brochure. The staff Pharmacist authorized nuclear Pharmacist compared these references to the NRC regulations and determined that BPS met the pharmacist. NRC requirements.

The staff reviewed the two program changes submitted in the BPS response letter and determined that compliance with the NRC regulations was not impacted.

The staff reviewed the two certificates provided: 1) BPS Board Certified Nuclear Pharmacist certificate, effective January 1, 2018, to December 31, 2019, and 2) BPS Board Certified Nuclear Pharmacist certificate, effective January 1, 2020. The staff updated the NRC public website.

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Based on the response letter and the NRCs subsequent review, the BPS certification process for the Board Certified Nuclear Pharmacist specialty area continues to satisfy the board recognition criteria in 10 CFR 35.55.

9. Canadian College of Physicists in Medicine (CCPM)

Radiation 10 CFR 35.51, Authorized The staff reviewed the Regulations of the Canadian College of Physicists in Medicine, Oncology Training for an Medical June 2021 document, which was located on the boards publicly available website, and Physics authorized medical Physicist determined that the program was in compliance with training and eligibility requirements in physicist. 10 CFR 35.51(a)(1) and (2).

The staff reviewed Medical Physics Questions for Membership Examination, Edition 12.1 and determined that the program was in compliance with the examination content specified in 10 CFR 35.51(a)(3).

The CCPM confirmed that the certificate on the NRC public website was current.

Based on the response letter and the NRCs subsequent review, the CCPM certification process for the Radiation Oncology Physics specialty area continues to satisfy the board recognition criteria in 10 CFR 35.51.

10. Certification Board of Nuclear Cardiology, Part of the Alliance for Physician Certification and Advancement' Medical Specialty Boards and Certification Programs (CBNC)

Nuclear 10 CFR 35.290 Authorized User The staff reviewed the CBNC public website including Core Cardiology Training Cardiology Symposium (COCATS) Guidelines, Information & Templates for Preceptors, and Content Outline & Scope of Knowledge. The staff compared the program material to the 10 CFR 35.290 regulations and concluded that it met the NRC requirements.

The staff reviewed the new CBNC Nuclear Cardiology certificate, effective on January 1, 2022. The staff updated the NRC public website.

Based on the response letter and NRCs subsequent review, the CBNC certification process for the Nuclear Cardiology specialty area continues to satisfy the board recognition criteria in 10 CFR 35.290.

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11. Certification Board of Nuclear Endocrinology (CBNE)

Nuclear 10 CFR 35.190 Authorized User DISBANDED. Unable to perform evaluation. See Section VI for further discussion.

Endocrinology Low Dose 10 CFR 35.392 Nuclear 10 CFR 35.190 Authorized User DISBANDED. Unable to perform evaluation. See Section VI for further discussion.

Endocrinology High Dose 10 CFR 35.394 14

VI. Related Topics Disbanded Board - Certification Board of Nuclear Endocrinology On January 1, 2013, the staff granted NRC recognition of the CBNE certification processes after reviewing the specialty board application to ensure that CBNEs certification processes met NRC requirements. There is no evidence that CBNE was out of compliance between the time of their recognition and when they became inactive. Therefore, the NRC will no longer recognize CBNE certificates issued after September 27, 2019, when CBNE became inactive.

The CBNE did not respond to the NRCs confirmation letter used for this evaluation, dated March 15, 2022 (ML22069A714); the NRC received a return to sender notification. Coupled with the lack of response, the staff observed that the CBNE website was inactive, the telephone was disconnected, and no email address was available. The staff reviewed the archive of documents on ADAMS. The last documented NRC contact with CBNE was on September 17, 2013, when CBNE submitted two certificates to the NRC. The staff did not receive any communication about this board disbanding.

Through a CBNE letter, dated February 22, 2011 (ML111260527), the staff were aware of a relationship between CBNE and the American Association of Clinical Endocrinology (AACE).

The staff contacted AACE, and the staff learned from AACE that CBNE had disbanded. AACE did not have information regarding when the last course or CBNE examination was provided.

The staff attempted to contact members of the past board at their medical practices. The staff were not successful with this effort. One past board member did respond (ML22159A276) but did not send confirmation that the specialty board had disbanded and did not provide the date of the last CBNE examination. On May 18, 2022, the NRC sent a letter (ML22129A095) to the last known chair of the CBNE to request confirmation of inactive status and to request the date of the last examination. A copy of this letter was also sent to the last known members of the CBNE board and to AACE. No response was received.

The NRC will no longer recognize CBNE certifications issued after September 27, 2019. The NRC staff based this date on the Florida Department of State records (ML22187A012), which confirmed that CBNE is inactive.

The NRC staff will terminate NRC recognition of the CBNE Nuclear EndocrinologyLow Dose and CBNE Nuclear EndocrinologyHigh Dose specialty areas. All changes in recognition processes will be communicated to the NRC regions, Agreement States, and the NRC public website will be updated.

Only candidates with CBNE certificates dated between January 1, 2013, and the termination date of September 27, 2019, will be recognized by the NRC as meeting the training and experience requirements. The staff is not aware of any individuals attempting to reference CBNE certification for licensing purposes after 2018.

Inactive Board - American Osteopathic Board of Nuclear Medicine On April 29, 2022, the staff received the AOBNM response letter (ML22122A155), which stated that the board went into an inactive status on March 5, 2019. The board decided to stop certifying new candidates based on a lack of interest in board certification in Nuclear Medicine.

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AOBNM was not aware that the NRC should be informed of the Board no longer certifying new candidates. The staff updated the NRC public website to clarify that the NRC will not recognize any AOBNM certificate issued after March 5, 2019. After AOBNMs intent to terminate NRC recognition is confirmed, the staff will complete the termination process.

The staff evaluated the AOBNM certification program, specifically the Nuclear Medicine specialty area, between May 18, 2006, the effective date of NRC recognition, and March 5, 2019. The staff determined that the Nuclear Medicine specialty area satisfied the board recognition criteria in 10 CFR 35.290 until the board became inactive on March 5, 2019.

Missing Certificate - American Board of Health Physics At the beginning of this evaluation, the staff did not have an ABHP certificate. The NRC recognized this board in 2006 with an effective date of January 1, 2005. The missing certificate was identified as an error in the NRCs self-assessment of specialty board certification processes. In October and November of 2019, the staff tried to contact the ABHP via the telephone and email but did not receive a response. The NRC sent a February 14, 2020, letter (ML19357A271) to the ABHP requesting the certificate, but ABHP did not respond.

During this evaluation, the staff were successful in contacting ABHP. The specialty board informed the NRC staff that the board was under new management and that the NRC letter had not been shared with the new management. The staff emailed the new executive director of ABHP a copy of the February 14, 2020, letter on March 9, 2022.

On March 25, 2022, ABHP replied to the February 14, 2020, letter with a response letter (ML22081A236) and two certificates. One certificate was used between January 1, 2005, and December 31, 2017. The other certificate became effective on January 1, 2018, and is still in use. The two ABHP certificates were added to the NRC public website.

This matter has been resolved and the ABHP is in good standing.

Intent to Terminate - American Board of Radiology During the specialty board evaluation, ABR announced their intent to terminate NRC recognition of all ABR certification processes. ABR communicated this intent in a letter dated April 6, 2022 (ML22091A272) and stated that they intended to terminate by December 31, 2023. The letter also stated that ABR would continue to comply with the NRC regulations until that date. The staff will initiate the formal termination process with ABR six months before the intended termination date. Engagement on the impacts of this termination has begun.

The ABR currently maintains six specialty areas with NRC recognition, as shown in Table 2.

The ABRs certification processes include authorized user-eligible (diagnostic radiology, interventional radiology/diagnostic radiology, radiation oncology), radiation safety officer-eligible (diagnostic medical physics and nuclear medical physics), and authorized medical physicist-eligible (therapeutic medical physics).

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After ABRs termination date, individuals seeking to be recognized as authorized users, RSOs or associate RSOs, and authorized medical physicists on NRC licenses can choose between two options: 1) to obtain certification from a different NRC-recognized specialty board or 2) to use the alternate training and experience pathway2 (alternate pathway) in 10 CFR Part 35 by providing documentation of the required training and experience to the NRC or Agreement States via the licensing process. The staff is engaging with external stakeholders to understand the impacts of ABRs termination request and to explore potential mitigation strategies, as appropriate. The current feedback from some professional societies is that the impact to the medical community may not be severe. The staff plans to hold meetings with the Agreement States, the medical community, professional societies, and other stakeholders to discuss potential impacts in fall 2022. The staff will also seek advice from the Advisory Committee on the Medical Uses of Isotopes regarding opportunities to mitigate potential impacts to the medical community.

Table 2. ABR currently issues certificates for six different NRC-recognized specialty areas. The ABR certification process supports candidates seeking positions as RSOs, associate RSOs, authorized medical physicists, and authorized users.

Specialty Areas NRC Regulations Positions Diagnostic Medical Physics 10 CFR 35.50 RSOs and Associate RSOs Nuclear Medical Physics 10 CFR 35.50 RSOs and Associate RSOs Therapeutic Medical Physics 10 CFR 35.51 Authorized Medical Physicists Interventional Radiology / 10 CFR 35.290 Authorized Users Diagnostic Radiology 10 CFR 35.394 10 CFR 35.390 Radiation Oncology 10 CFR 35.490 Authorized Users 10 CFR 35.690 10 CFR 35.290 Diagnostic Radiology Authorized Users 10 CFR 35.392 2

The alternate pathway is a set of training and experience criteria that includes classroom and laboratory training, supervised work experience, and preceptor attestation, established in 10 CFR Part 35. The approval process is based on an evaluation by the NRC or an Agreement State during the licensing process. This evaluation can be used to ensure compliance with the NRC training and experience requirements when an NRC-recognized specialty boards evaluation of the candidates training and experience is not applicable.

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VII. Public Record The following documents were added to ADAMS as publicly available to maintain transparency and accessibility.

Table 3. The ADAMS Accession numbers corresponding to each of the following documents are listed for each specialty board.

Confirmation Specialty Boards Communication Completion Specialty Boards Letters Response Letters Logs Letters American Board of ML22081A236 ML22068A013 ML22129A194 ML22139A316 Health Physics ML22095A153 American Board of ML22068A111 ML22101A057 ML22129A190 ML22139A318 Medical Physics American Board of ML22105A576 ML22069A712 ML22161A536 ML22145A560 Nuclear Medicine ML22151A323 American Board of ML22068A133 ML22112A120 ML22161A335 ML22145A554 Radiology American Board of Science in Nuclear ML22069A178 ML22090A256 ML22129A184 ML22139A314 Medicine American Osteopathic ML22122A154 This board is in the Board of Nuclear ML22068A145 ML22159A304 ML22153A359 termination process.

Medicine American Osteopathic ML22069A713 ML22102A319 ML22159A294 ML22145A551 Board of Radiology Board of Pharmacy ML22068A014 ML22081A300 ML22129A147 ML22139A327 Specialties Canadian College of ML22069A715 ML22095A147 ML22129A177 ML22139A319 Physicists in Medicine Certification Board of Nuclear Cardiology, Part of the Alliance for Physician Certification and Advancement' ML22068A015 ML22101A069 ML22161A041 ML22139A323 Medical Specialty Boards and Certification Programs Certification Board of This board is in the Nuclear ML22069A714 None ML22159A276 termination process.

Endocrinology VIII. Conclusion The staff determined that 9 of the 11 specialty boards are still active and continued to meet the NRC recognition criteria as established in the regulations. The NRC public website was updated to reflect changes in the certificates.

The staff evaluation of ABR certification processes determined that each NRC-recognized specialty area was in compliance with the NRC requirements. The staff reviewed the ABR letter dated April 6, 2022, in which ABR communicated their intent to terminate the NRC recognition of all ABR certification processes that meet the training and experience requirements in 10 CFR Part 35. ABR will continue to be an NRC-recognized specialty board until the NRC terminates 18

the recognition on December 31, 2023. The staff will initiate the termination process with ABR six months before the intended termination date.

The staff determined that two boards, AOBNM and CBNE, were inactive. The AOBNM participated in the review, and the staff determined that their certification processes had complied with NRC requirements. AOBNM became inactive on March 5, 2019. The NRC will terminate its recognition of AOBNM after the board confirms that is its intent. CBNE did not participate in the review and the staff were unable to conclude that it satisfied the NRC requirements prior to its inactive status. The NRC terminated the recognition of the CBNE certification processes and will not recognize any CBNE certificate issued after September 27, 2019.

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