ML20236T779
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4, UNITED STATES pt NUCLEAR nEGULATORY COMMISSION WASHINGTON. D. C. 20555
..... Ref: SA/ LAB, J;J 0 71931 8 '
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MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and i fR g
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Material Safety, NMSS FROM: G. Wayne Kerr, Director Office of State Programs
SUBJECT:
COMMISSION PAPER ON QU.LITY ASSURANCE IN RADIATION THERAPY AND PENALTIES FOR NEGLIGENCE We have reviewed the subject document and we offer the following comment.
The timetables set for these rulemaking packages do not recognize the nc.d to coordinate the proposals with the Agreement States. We would like this aspect to be addressed in the Commission paper and ask that the section provided in the enclosure to this memo be included under a heading "Effect on Agreement States." We are not asking that any schedules be changed, however.
Each Agreement State was sent a copy of this rulemaking package and asked to respond by January 9, 1987. We will forward their comment (s) to you when received.
, G. Wayne I rr, Director Office of State Programs
Enclosure:
As stated 9712O20086 071201 POR PR 35 52,FR36,942 m PD,R _
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i Comments Effect on Agreement States In the comprehensive revision of 10 CFR Part 35, the Commission made the misadministration reporting requirement a matter of compatibility for
' Agreement State regulations. The staff believes that the purpose of quality assurance rules for therapy dictates that they also be'made a matter of compatibility with Agreement State regulations.
The Agreement States regulate approximately two-thirds (2/3) of the medical licensees in the United States. Thus, State regulatory agencies may be expected to provide pertinent comments, and should be consulted on the draft rules and on the matter of the proper role of a regulatory organization in the delivery of medical care.
The staff customarily provides a minimum of 45 days for the Agreement States to review and connent on draft rulemaking proposals and their comments are accommodated to the extent practicable. Agreement State input to our rulemaking is especially important where compatibility is required. In this rulemaking the schedules do not permit this time period for State review and comment. To accommodate the Commission's request for action within specified deadlines, the staff informed the Agreement States by telephone on December 23, 1986 of staff actions planned and.sent copies of the draft ANPRM and quality assurance rule to them on December 29, 1986 with a request for input by January 9,1987.
It should be noted that, with all new regulations which are matters of compatibility, NRC guidelines provide that the Agreement States have three (3) years from the effective date of the rule to adopt an equivalent regulation.
The staff will consult separately with the Agreement States on the matters covered by the Advance Notice of Proposed Rulemaking (ANPRM).
It is possible that the States will establish a small working group to ccnsult with the NRC staff. In view of the Commission's target dates for the ANPRM, such consultation will have to take place at least in part, after publication of the ANPRM. The target dates set for the ANPRM may not permit a full opportunity 'n obtain conrnents and j assistance from the States, but the stafr will do its best to coordinate j this matter with the Agreement States, i
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