ML20058F039
| ML20058F039 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Metter D Advisory Committee on the Medical Uses of Isotopes |
| Sarah Lopas 415-6360 | |
| References | |
| Download: ML20058F039 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 February 27, 2020 MEMORANDUM TO:
Darlene Metter, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM:
Christian Einberg, Branch Chief
/RA/
Medical Safety and Events Assessments Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RECOMMENDATIONS ON TRAINING AND EXPERIENCE REQUIREMENTS FOR RADIOPHARMACEUTICALS REQUIRING A WRITTEN DIRECTIVE (10 CFR 35.300)
Below are the U.S. Nuclear Regulatory Commission (NRC) staff responses to recommendations from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on training and experience (T&E) requirements for radiopharmaceuticals requiring a written directive. The ACMUI provided two sets of recommendations. Two recommendations were made in the February 27, 2019, final Subcommittee report on T&E requirements for uses under 10 CFR 35.300, Use of unsealed byproduct material for which a written directive is required (Agencywide Documents Access and Management System [ADAMS] Accession No. ML19058A598); and three recommendations were made in the October 23, 2019, final Subcommittee report providing comments on the staffs draft SECY paper, Evaluation of Training and Experience Requirements for Administration of Radiopharmaceuticals Requiring a Written Directive (ADAMS Accession No. ML19296D256).
- 1. ACMUI Recommendation: The Subcommittee does not recommend a limited-scope AU pathway for unsealed byproduct material for which a written directive is required.
Staff Response: Accepted. While the staffs evaluation in SECY-20-0005, Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (ADAMS Accession No. ML19217A318) included a discussion of the pros and cons of tailored T&E, the staff ultimately did not recommend tailoring T&E requirements for certain radiopharmaceuticals.
CONTACT: Sarah Lopas, NMSS/MSST 301-415-6360
D. Metter 2
- 2. ACMUI Recommendation: If the NRC chooses to pursue the creation of a limited-scope authorized user (AU) pathway for unsealed byproduct material where a written directive is required, the AU candidate must acquire the basic knowledge topics in 10 CFR 35.390 and satisfactorily complete a formal competency assessment. Furthermore, the individual's continued status as a limited-scope AU is dependent on successfully maintaining a formal periodic reassessment of competency.
Staff Response: Partially accepted. The staffs evaluation of T&E for radiopharmaceuticals in SECY-20-0005 did not recommend creation of a limited-scope AU pathway, therefore, no T&E requirements were specified. However, the ACMUIs position that even limited AUs should acquire the basic knowledge topics currently required in 10 CFR 35.390, and that continued limited AU status should be contingent on periodic competency evaluations, informed the staffs consideration of potential options for revising the current T&E requirements.
- 3. ACMUI Recommendation: The Subcommittee recommends maintaining the status quo under 10 CFR 35.390. While strongly affirming the structural superiority of the status quo over the other options proposed in the draft paper, we acknowledge there is room for a comprehensive review of the specific requirements in 35.390 such as the seemingly arbitrary requirement of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. The Subcommittee would welcome the opportunity to critically asses these details.
Staff Response: Partially accepted. In SECY-20-0005, the NRC staff reviewed but did not recommend maintaining the status quo. Instead, the staff recommended a rulemaking that would revise the current prescriptive T&E regulations for all unsealed radiopharmaceuticals to require that AUs be certified by a medical specialty board recognized by the NRC or an Agreement State. If approved by the Commission, the NRC, in coordination with the ACMUI and Agreement States, and with input from the medical community, would revise the medical specialty board recognition criteria during rulemaking.
The NRC staff welcomes the T&E Subcommittees offer to critically assess the current requirements in 10 CFR 35.390.
- 4. ACMUI Recommendation: If the NRC proceeds to grant AU status by NRC-recognized specialty boards, the T&E should be equivalent to 35.390.
Staff Response: Partially accepted. As discussed in the response to ACMUI recommendation No. 3, the staff will coordinate with the T&E Subcommittee to determine the revised T&E requirements for medical specialty board recognition. However, as part of the staffs development of a rulemaking plan for the Commissions consideration, the staff did not yet determine the T&E requirements for the recommended rulemaking. If the Commission approves the staffs recommended rulemaking, this determination will be part of a coordinated effort with the ACMUI, Agreement States, and the medical community during the rulemaking process.
- 5. ACMUI Recommendation: The subcommittee recognizes the value of an alternate pathway and is willing to review and evaluate the requisite knowledge, preceptor-reviewed experience, and competency assessments.
D. Metter 3
Staff Response: Accepted. As stated above in the responses to ACMUI recommendations No. 3 and 4, the staff welcomes the T&E Subcommittees evaluation of the value of the alternate pathway, and the appropriate knowledge topics, work experience, and competency assessment requirements for that pathway, and any revisions to medical specialty board recognition and AU credentialing requirements.
- via e-mail OFFICE MSST/MSEB:PM MSST/MSEB:TL MSST/MSEB:BC NAME SLopas LDimmick*
CEinberg*
DATE 2/20/2020 02/25/2020 02/27/2020