ML20155B913
| ML20155B913 | |
| Person / Time | |
|---|---|
| Issue date: | 04/06/1988 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Congel F NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20155B900 | List: |
| References | |
| NUDOCS 8806140016 | |
| Download: ML20155B913 (3) | |
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- April 6, 1988 MEMORANDUM FOR: Frank J. Congel, Acting Director Division of Radiation Safety and Safeguards, RI FROM: Richard E. Cunningham, Director Division of Industrial and Medic.al Nuclear Safety, NMSS
SUBJECT:
ME01 CAL USE PROGRAM This is in response to your memorandum of March 23, 1988 regarding implementation of the revised 10 CFR Part 35.
Your comments on matters that should be addressed to ensure quality and consistency in medical use licensing and inspection are most helpful.
Unfortunately, the timely fine-tuning of the medical use regulation and guidance on licensing and inspection has been hampered by the resources budgeted for medical use and the Commission's directive to prepare rules on quality assurance in radiation therapy; we expect these hurdles to dissipate in the coming months with the anticipated full staffing of the Medical and Academic Section and the publication of a final rule on quality assurance.
Concise responses to the matters you raised are provided in an enclosure.
These responses will be incorporated in the next revision of Policy and Guidance Directive FC 87-2.
r Richard E. Cunningham, Director Division of Industrial and Medi::al Nuclear Safety, NMSS
Enclosure:
As stated
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8806140016 REG 1 SUBJ 880607 b ncnal _ _ . _ _ _
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NOTES ON IMPLEMENTATION OF 10 CFR PART 35
- 1. 10 CFR 35.14 Notifications. A requirement for notification that a key incividual has left a licensee's program was included in the regulation as a perfonnance indicator. The list of key individuals may be updated when processing the next amendment submitted by the licensee under 10 CFR 35.13. To update the license in response to each notification would increase the licenung action caseload with no demonstrable public health and safety benefit.
- 2. 10 CFR 35.31 Radiation Safety Program Changes, and 10 CFR 35.13 License Amendments. The licensee actions that require NRC approval are listed in 10 CFR 35.13. Other actions that formerly required NRC approval may now be made by the licensee. The list of examples in 10 CFR 35.31 should not be interpreted restrictively; licensees may make other minor changes that are not listed in that section. Licensees may not ignore procedures submitted in the license application; those are the procedures that must be implemented by the Radiation Safety Officer. Licensees may make minor changes in the radiation safety procedures for efficiency or convenience. The licensee is responsible for assuring that any change made is in compliance with the requirements of the regulations and the I license. This authority is similar to that granted to reactors under 10 CFR 50.59,
- 3. Sealed source and device model numbers. These numbers were purposefully not included on license accuments so that licensees could select from a variety of vendors. Headquarters staff is assembling a compatibility l matrix for use by licensees and staff.
- 4. "Authorized use" descriptors. The phrase "medical use as described in 10 CFR 35.100," for example, was chosen because that section describes a generic type of medical use. The section does not "approve" specific clinical procedures. Therefore, the wording used in the standard review plan should be used on licenses.
- 5. Broad licensee scope of authority. The sample broad license on page 2.13 l of Folicy and Guidance Directive 87-2 would allow the Radiation Safety l Committee to make case-by-case exceptions to training and experience t criterio. License reviewers are not required to issue such authority to '
broad licensees. Such authority may be issued if the license reviewer believes it will not negatively impact public health and safety.
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- 6. Wording of scope of authorization for broad licensees. Recommended possession limits will be reviewed during the revision of the broad license regulatory guide. The terms "medical use" and "research and development" are defined in 10 CFR 30.4. Licenses should continue to be worded in accordance with the Policy and Guidance Directive 87-2.
- 7. Content of applications. In its approval of the revision of 10 CFR Part 35, the Commission directed that the staff continue to review licensees' radiation safety procedures. The reviewer should examine each submission to assure that the procedure meets the requirements Of the applicable regulation in a complete and technically valid way. The submission does not need the extensive detail that characterizes the procedures in Regulatory Guide 10.8; that detail was provided because the guide is also used as a methods training manual for hospital radiation safety workers.
- 8. Exceptions to training and experience criteria. License reviewers may make case-by-case exceptions for authorized users whose training and experience do not exactly meet the criteria in Subpart J. Because these exceptions would be occasional and made case-by-case, we consider development of guidance on this matter to be of low priority. License reviewers may refer these cases to the Advisory Committee on the Medical Uses of Isotopes.
- 9. Authorization for specific clinical procedures. If a licensee wants to provide a single clinical procedure, the license may be written to ;
reflect that. Examples are provided on pages 2.2, 2.5, 2.10, and 2.12 of !
Policy and Guidance Directive 87-2.
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- 10. Teletherapy reports. (a) Materials staff should review licer.;ee reports
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of safety checks and shielding surveys submitted in conformance with 10 CFR 35.645 for completeness and reasonabler.ess. (b) Sample procedures will be developed in the teletherapy regulatory guide that is under revision. (c) 10 CFR 35.645 does not require submission of a complete teletherapy calibration report.
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