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Mb e UfDUM FOR: William J. Dircks
'b Executive Director for Operations Neyr T._
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G. Wayne Kerr Director s
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Office of State Programs Mk M3 y.I
SUBJECT:
PROPOSED REVISION OF 10 CFR PART 35 gg.
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We have reviewed the staff paper on the proposed revision of 10 CFR Part g p.3 35 which Bill Travers provided us and we have the following coments:
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1.
In my memo to Richard E. Cunningham dated August 31, 1982 comenting on an earlier version of this paper, we stated that L3
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we were not opposed to publication for coment but that the
- n paper should more fully address coments by the Agreement States. We also stated that it would be useful for 2455 to
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- i-prepare a sumary of Agreement States' positions accepted or
.C rejected and the related rationale that we could send to the
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, Agreement States at the time of publication. The latter suggestion was not accepted. The concurrence page indicates a:.
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that my memo recomends publication for coment which is not accurate; my memo stated no objection to publication for f
m coment.
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2.
The second paragraph of page 4 of the paxer does not clearly reflect the Agreement States concern witi the proposal. We suggest the following paragraph be inserted in lieu of the
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paragraph in the paper to indicate the Agreement States' reaction to the proposal:
"Most Agreement States are in favor 3
of consolidating requirements in the regulations and support "y~ p this step. The Agreement States' concern is that under the ndg proposal, applicants (and licensees) would be required to have w
- safety procedures but the procedures would not be submitted a
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for review by the NRC. The applicant (or licensee) would pn merely certify on the application fom that the procedures V
have been established. The adequacy of the procedures would s: L not be detemined until sometime after the license is issued.
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In addition, the States do not agree with the provision in the proposal which allows licensees to change safety procedures "GF without prior review by the NRC. The NRC's frequency of 3
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E N ~. inspection for medical licensees is once every 3 years
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although new licensees are scheduled for inspections within x.
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8509230347 850906 PDR PR p;rc,e im.
35_50FR30616 PDR ifh 1 -
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the first six months of operation. Although this C'
y R" regulation would not be made a matter of compatibility because WM,1 it deals with licensing procedures, the States believe they T
y.f will receive pressure from their licensees to adopt the NRC y
The staff feels that the,
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$"W'E Rsystem with which they don't agree.
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2 current effort will not decrease, but will enhance safety
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(1) staff resources can be
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mvs redirected from case-by-case reviews to development of p"
guidance and integration of technical developments into licensing decisions (2) the clear specificatims of all de essential safety requirements in the regulation, and (3)
A@%j Md...ddt..n'!r detailing the minimum acceptable training and experience for medical users of radioisotopes in the regulations. MRC may h}gg(D,
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supplement its review with an early on-site post-licensing hg:; ?
visit. Ability to do so is enhanced by regionalization."
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3.
At the annual Agreement States meeting in October,1982 and in hi? '
correspondence following the meeting the States requested that MS -
a designated representative be allowed to address the kF Comission when it takes up this paper. We suggest the following Note be added to the paper: " Note that the
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Agreement Ttafes have requested that a representative a
ilh designated by them be allowed to aresent their views on this L.
proposal to the Commission when tie Comission meets to 1.n ~.
consider this proposal."
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To appropriately reflect the Agreement States concern, we g
propose the following change to page 17 of enclosurt 3:
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Agreement States Yj
- y Many Agreement States are in favor of consolidating the h:h various regulatory requirements and support this revision of e
^;d.ge the regulations. However, the Agreement States are concerned y
about the impact of the proposed licensing procedures.
- n < L Agreement States regulate about 4700 medical licenses. Most feel that a prelicensing review of safety procedures is b-necessary to ensure safety. They believe that failure to M-review procedures and permitting the licensees to make program eH;-
changes without prior review and a) proval is an unprecedented
.WY relaxation of regulatory control w11ch could cause harm to 14 patients and the public. Their contention is that they may be
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pressured by their own licensees into adopting NRC's revised procedures without the benefit of an expensive Management
.,4 Information System (MIS) computer like NRC's. The NRC staff believes that, since the Agreement States are not required to y**
maintain comsetibility with NRC in the area of medical C 'D ~
- J'1 licensing, t1ey would have the option of incorporating into s
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m4 ?. their programs those features that they find desirable while tejecting those feature that they find objectionable. The 6:: App;;.
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Agreement States have expressed concern about the allocation of additional money and personnel to fulfill the extra
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inspection requirement of this revision. They have also asked about the time frame for the early on-site post-licensing w:, n f
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In htplementing the rule, tin H2G staff recognizes that there nay te a need for difftxcaces betucea NRC and
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5 Agreement Stato procedures. The staff feels that the currcut b;gV ef fort uill not decrease,)but will enhance safety through I.'
C l-three major-features:
(1 redirecting staff resources from My't.
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E case-by~ case revious to developing guidance and intergrating pg:2 r,
Af;pEKy technical developments into licensing decision, (2) specifying. 3.;
IC.w.* all essential safety requirements in the regulation, and mf # a (3) detailing in the regulaticn s the minimum acceptable f.y
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training and experience for medical users of radioisotones.
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NRC may supplement these features with 'an early on-s.ite
$dak post-licensing visit."
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The last sentence of the quoto above indicates the NRC may_
f.f;j take supplemental measures at tha post-licensing stage Fut f,
.-~4\\ _.there is no f t n comittr.cnt to do so; wa believo such a
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ccmitmdnt'is ntcenary to ensera tha effectiveness of this Mr-l2;n ',
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