ML20236J332
| ML20236J332 | |
| Person / Time | |
|---|---|
| Issue date: | 05/08/1998 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20236J272 | List: |
| References | |
| REF-10CFR9.7 SECY-98-054-C, SECY-98-54-C, NUDOCS 9807080137 | |
| Download: ML20236J332 (3) | |
Text
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. NOT ATIO N VOTE 1 \
RESPONSE SHEET l
TO: John C. Hoyle, Secretary I l
FROM: COMMISSIONER MCGAFFIGAN !
SUBJECT:
SECY-98-054 - COMMISSION RESOLUTION OF l SIGNIFICANT ISSUES ASSOCIATED WITH THE REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT !
MATERIAL" Approved V Disapproved x Abstain Not Participating Request Discussion COMMENTS:
'See attached comments.
l w b.
SIGNATURE $/ O 6 Release Vote / '</ 8 , ID 8 DATE O Withhold Vote / /
Entered on "AS" Yes Y No 98o7o00137 900626 7 oRRESP DE E PDR
, , . . - ~ ,
i Commissioner McGafligan's Comments on SECY-98-054:
ISSUE.1, - Patient Notification I support the Altemative I approach--to retain the current reporting requirements in Part 35 with minor changes as indicated by the staff--subject to the following.
I am sensitive to' the concern by some members of the medical community that the requirement in 10 CFR 35.33(a)(4)--to provide the informed individual with a copy of the licensee's report to the NRC (or a similar report)- " greatly magnifies the significance of the event when, in fact, a 1 medical event could be of minimal safety significance." As a result, I believe that 10 CFR 35.33(a)(4) should be modified to read as follows:
(4) If the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual that includes a brief description of the event and the consequences as they may affect the individual.
I also am concerned that, historically, the NRC resources expended on pursuing whether the referring physician has provided adequatejustification for not informing the patient or whether a responsible relative has been notified, have in some cases been disportionate to the risk posed to the patient as a result of the -misadministration. In this resource constrained era, I believe that the staff should limit its resource expenditure on such " low-risk" misadministration and ic2,tead focus its limited resources on more significant misadministration where a potential for patient harm is expected or has been demonstrated. I 1 disagree with statements in the paper that there is a lack of other Federal patient notification requirements, and offer the following regarding Federal mammography requirements. In October 1992, Congress passed "The Mammography Quality Standards Act" (Public Law 102-539) to establish national quality standards for mammography. In December 1993, the FDA promulgated interim regulations setting forth quality standards for mammography f acilities. In l October 1997, the FDA issued a final rule thtt becomes effective in April 1999. The final rule requires that,in cases where,"FDA determines that the mammography program at a facility may present a serious risk to human health, a facility must notify the patients or their designees, their physicians or the public of action that may be taken to minimize the effects of the risk." !
Currently, the Senate has passed and the House is considering bills (S. 537 and H.R.1289) to {
amend the Mammography Quality Standards Act to, inter alia, add a new section to the Act on patient notification. The bills will provide FDA with the authority to require a facility to notify l patients (and their referring physicians) of, among other things, the potentiel harm rest ' ing from ;
mammogram that may have been of poor quality because of deficiencies in the mamm aphy l program at that facility. As a result, I would argue that not only is it appropriate for N K n. i I
retain patient notification requirements but it is also consistent with how Congress is dealy with mammography as another source ofionizing radiation.
I i\-
i 2
. ISSUE 2 - Precursor Events I approve the staff and ACMUI recommendation to pursue Alternative 2 for how best to capture I precursor events with one modification. I do not support incorporation of the proposed language,
' "in the opinion of the radiation safety officer." This approach is inconsistent with other reporting . !
l requirements such as those in 10 CFR 34.30 and 36.83, which make the licensee responsible for reporting certain events and are silent with regard to who at the licensed facility makes the l determination of deportability. I believe that enforcing such a provision will be problematic for NRC particularly in the event that licensee personnel disagree with the RSO's determination yet
' NRC proposes to hold the RSO personally responsible. Such cases will result in the expenditure of scarce NRC resources for little or no public health and safety benefit, and this approach may i prove to be a disincentive for licensees to promptly report precursor events. It may also discourage certain well-qualified individuals from taking on the role of RSO at a time when such individuals are in somewhat short supply, I do not believe that this is the effect that NRC is -
after.
The staff should consider developing specific examples of events for inclusion in the proposed I rule package or rule itself to fully describe the intent of the proposed requirements. The Fede'ral ,
Register notice should also solicit comments on the estimated number of events per licensee that will meet these reporting thresholds to provide NRC with better data on which to base a cost- I i
benefit analysis and make a decision on provisions of the final rule.
Finally, by using the Alternative 2 approach in the proposed rule, the staff has the flexibility to modify the final rule to use the Alternative 3 approach if public comment is not supportive of ;
specific rule text in Part 35 for the purpose of capturing precursor events. For the reasons above, I support Alternative 2 for'how best to capture precursor events.
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i Y___________-_____-_:__-_____----___-_____ ___________:_________
p UNITED STATES
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' . NUCLE AR REGULATORY COMMISSION j
W ASHINGTON. D.C. 20G55
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% ,# June 26, 1998 OFFICE OF THE SECMETARY MEMORANDUM TO: L. Joseph Callan Executiv Dir orfo Operations FROM: John QI oyle, e t
SUBJECT:
SECY 98-054 - COMMISSION RESOLUTION OF SIGNIFICANT ISSUES ASSOCIATED WITH THE REVISION OF 10 CFR PART 35,' MEDICAL USES OF BYPRODUCT MATERIAL" l This is to advise you that individual Commissioners voted on SECY-98-054 but a staff requirements memorandum will not be issued since the paper and the issues it presented are ,
included in and have been superseded by SECY-98-128 ' Proposed Rule: Revision of 10 CFR l Part 35, Medical Use of Byproduct Material,' dated June 4,1998. The Commission intends to !
address the issues raised in SECY 98-054 in the context of the new paper.
This completes action on SECY 98-054.
cc: Chairman Jackson -
Commissloner Dicus Commissioner Diaz Commissioner McGaffigan g\ tf,,
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OCA OPA SECY NOTE: THIS MEMORANDUM, SECY-98-054, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM,
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