ML20236R537
| ML20236R537 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1998 |
| From: | Diaz N NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20236R530 | List: |
| References | |
| SECY-98-128-C, NUDOCS 9807220103 | |
| Download: ML20236R537 (2) | |
Text
._ _. _ ___ __ .______________ ___-______ _ ____ __ _ __
NOTATION VOTE RESPONSE SHEET l
TO: John C. Hoyle, Secretary FROM: COMMISSIONER DIAZ
SUBJECT:
SECY-98-128 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL' USE OF BYPRODUCT MATERIAL wit omments Approved x , , A Disapproved Abstain v
Not Participating Request Discussion COMMENTS:
See attached m M A i/ i .A SIGN TdFle ~
Release Vote / 2 / G lo %
DATE I Withhold Vote / /
Entered on "AS" Yes x No E 7"!OA0s E c"*
CORRESPONDENCE PDR 9%D [ ')/O (D i
. l Commissioner Diaz's Comments on SECY 98-123 3 The staff should be congratulated for the extensive amount of work completed according to the schedule. Although the rule is not performance-based. it is risk informed. I have the following specific comments on the proposed rule:
I
- 1. I support the elimination of the requirement for a radiation safety committee. I believe that licensee's management should have the flexibility to decide in what settings they wdl address the requirements of the licensee's radiation protection program. I would clanfy ,
that the radiation safety officer should be given appropriate tools and channels through j which to raise safety concerns to the highest levels.
- 2. I support the NRC requirement for notification of patients of medical events. However, I believe the requirement in 35.3047 for reporting of certain doses to the embryo / fetus or nursing child should not be limited only to medical licensees, but to all licensees and as such be a requirement in Part 20. Also, the requirement for reporting to NRC of any dose to an embryo / fetus or nursing child greater than 5 mSv should include a requirement to notify the mother.
- 3. I still continue to support the elimination of new requiremcats for precursor events in the proposed rule. Given our scarce resources and that the existing regulatory framework captures the necessary precursor incidents I believe the new requirements are not needed.
- 4. I agree with Commissioner Dieus that it is not clear why the NRC is increasing the training and experience (T&E) requirements for endocrinologists absent information of significant deficiencies in the present requirements or poor performance based on significant medical events. Furthermore, a case hasn't been made that our present requirements, for all medical licensees, are lacking. Therefore, I support maintaining the present T&E requirements.
- 5. At this time I am not persuaded that this elaborate " examination process" is an improvement over our current T&E requirements. I am concerned with the concept of NRC approving third parties to certify or examine persons for adequacy of T&E. This additional regulatory layer is not necessary. I am also concerned with the NRC resources which would be needed for implementation which were not delineated in the paper. I agree with Commissioner Dicus that the Commission should have full information on the FTE effort that will be required and from where it will be obtained.
- 6. I recommend the new requirement for calibration of all brachytherapy sources by the licensee before initial use be revised to allow calibration by the manufacturer traceable to NIST or other recognized bodies as an acceptable means of meeting the requirement of j
the proposed rule, I
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