ML20137Q932
Text
h> 'mL sus) b 00 44)l
~
MEMORANDUM FOR: William J. Dircks M ) L ,
Executive Director for Operations N /f4.4%O4%,M t f.A4. dA U. ; 3 & c:a FROM: John G. Davis, Director g#
Office of Nuclear Material Safety and Safeguards
SUBJECT:
PROPOSED REVISION OF PART 35 The staff has prepared a proposed revision of 10 CFR Part 35, " Human Uses of Byproduct Material," (retitled " Medical Use of Byproduct Material") for public comment. The proposed revision is based on SECY-83-62 and the Commission's response to that proposal. Several Headquarters Offices, each Regional Office, and the Agreement States were asked to comment on this proposal.
The Cost Assessment Group has reviewed the Regulatory Analysis and their comments have been resolved.
Based on Enclosure 7 of the Commission paper and pursuant to 10 CFR 51.31, I have determined that this proposed rule, if adopted, will not have a significant environmental impact. .,
Two Agreement State individuals from the Conference of Radiation Control Program Directors' Ad Hoc Committee on Part 35 provided technical comments and the Agreement State perspective during the development of this proposal. An earlier- draft proposal and draft Regulatory Guide 10.8 were sent to all Agreement, States for comment. _
. .y v : . .ug The Agreement States would like to speak to the Commission on this matter.
They generally endorse the proposed regulatory text, but do not endorse the licensing method that the staff recommends. Region III would prefer more license control. A discussion of these views is included as Enclosure 8. A
. range of alternatives and a discussion of each is provided as Enclosure 10.
The following offices have concurred with the proposal, indicating that they have no objection to publishing the proposed revision for comment: Office of Inspection and Enforcement, Office of Nuclear Regulatory Research, Office of Administration, Office of State Programs, Region I, Region II, Region III, Region-IV, and Region V. The Office of the Executive Legal Director has no legal objection.
(Signed) Jchn L LY'iS John G. Davis, Director Office.of Nuclear Material S.afety and Safeguards Enclosu : Proposed revision
, of 10 CFR Part 35 [ t) }
NMSSher .F.CML9 DD/ff , (Il/FC g /NMSS D/P SS D/AD D/EL NLMcElroy!VLMiller DKhapell RECunrfrhgham DMausshardt JGDavis PNorry GHCunningham 12/ /84 12/l^ /8j 12////84 3 12/ 12/p/847/27f848/22484 N 4y
)- D/IE V D/Sfyi",1 J s J 12//qf83)h',,D/RII[n)/84Y D/RIII h.)
t 0/RIV D/RV D/RES RBMinig[,
8/2/84
[ lie RCDe[Yob.'
8/3/84 J
ng GWKerf y D/RIpTEMurfeyJP0'ReihlyJGKep 8/7/84 er JTCollins 10/29/84 7/31/84 JBMa[rt$)
7/27/84 12/14/84 8/1/84 8509230320 850906 PDR PR 35 50FR30616 PDR
mRC Form's U.S. NUCLEAR REuULATORY COMMISSION RECOMMENDED DISTRIBUTION Office of the Secretary ORIGINATING OF FICE l CONT ACT l ExTENSON NMSS Norman L. McElroy 74108 TITLE OF PROPOSED PAPER Proposed Revision of 10 CFR Part 35 " Medical Use of Byproduct Material" PAPER TYPE l MEETING l l AFFIRMATION l l NOTATION l l lNFORM ATION DISTRtBUTION (Check bon for each rec @ent)
$ph's RECIPIENT yp,[9 RECIPIENT 1 3 CHAIRMA,N PALLADINO 1 3 ADMtNISTRATION g 2 ' COMMISSIONER 0Hl0G$x Roberts a 2 CONTaOttER 3 3 COMMissioNERosem Asselstine A 2 executive LEGAL DiRECTOa 2 COMMISSIONERmWK Bernthal i S MANAGEMENT & PROGRAM ANALYSIS EOu AL EuPLOvMENT OPPORTUNITY g 2 COMMISSONERnousex Zech i J_h g
A 2 ST ATE PROGRAMS INTERN ATION AL PROGRAMS I 1 CONGRESSONAL AFF AIRS l- 1 PUBLIC AFFAIRS 0 10 NUCLE AR RE ACTOR REGULATCN
[ S GENERAL COUNSEL g 2 INSPECTOR & AUDITOR ] I 4 NUCLE AR M ATERIAL SAFETY & SAFEGU ARDS
{ 4 POLICY EV ALUATON g 10 NUCLE AR REGULATORY RESE ARCH
{ to SECRETARY ] 2 AN ALYSIS & EV ALUAT ON OF OPER ATCN AL DAT A SMALL & DIS ADv ANTAGED BUSINE'SS UTILIZATON OFFICE l 1 CODER l 1
[ 2 DOCUMENT M ANAGEMENT BR. 3 INSPECTION & ENFORCEMENT
[ 3 1
EXECUTIVE DIRECTOR FOR OPERATIONS DEPUTY DIRECTOR FOR OPER ATONS 1 REGCN AL OFFICES KING OF PRUSSIA l 1 ATLANTA
's i CHICAGO 0 ADVISORY COMuiTTEE ON RE ACTOR S AFE Gu ARDS DALLAS g 2 ATOMIC S AFETY & LICENSING BOARD PANEL { 1 1 SAN FRANCISCO 2 ATOMIC S AFETY & LtCENSING APPE AL P ANEL {
Q TOTAL 42 _
SUBTOTAL '__
NUMBER OF COPIES +
~
NUM BE R OF COPIES 14 0 REMARKS RETURN ORIGIN AL TO:
I ORG ANIZ ATICN I Mall STOP NAME 396-55 Norman L. McElroy NMSS/MLB
~'
73-/
- ^
IN RESPONSE, PiEnhE REFER TO: M850320A
,., [p ar%% UNITED STATES f f' > '
_s
, y- ' #g NUCLEAR REGULATORY COMMISSION 'NCTION - Davis s, i W ASHINGTON, D .C. 20555 Cys: Dircks
'o '
,o8' Roe
\v***** March 29, 1985 rem o metorint
.' Stello SECRETARY J'
'j telicElroy g{gngjD9 ham Kerr f' i' Taylor MEMORANDUM FOR: William J Dircks, Executive Director for p r tion -
b FROM: John C .oyle, c ing Secretary
SUBJECT:
STAFF EQUIREMENTS - DISCUSSION OF PROPOSED REVISIONS TO PART 35, 10:00 A.M., WEDNESDAY, MARCH 20, 1985, COMMISSIONERS' CONFERENCE D.C. OFFICE (OPEN TO PUBLIC ATTENDANCE)
ROOM,84-485)
(SECY-The Commission
- met with staff, representatives from Agreement States, and members of the medical community to discuss proposed revisions to Part 35 of the NRC regulation entitled " Medical Use of Byproduct Materials."
Commissioner Zech requested that staff summarize in the state-ment of considerations to the proposed revision of Part 35 '
NRC's regulatory role with respect to patients receiving radiation therapy. In this connection, the Commission stated its intentiont to give early consideration to a review of NRC policy on the question of medical misadministration and enforcement action in misadministration cases.
(NMSS) (SECY Suspense: 4/19/85)
Commissioner Bernthal requested from staff a clearer definition of what would constitute a " minor change" in a licensee radiation safety program under the revised rule with a representative cross-section of the kinds of " minor changes" which have required license amendments in the past.
(NMSS) (SECY Suspense: 4/19/85)
Chairman Palladino requested that Commissioners address SECY-84-485 as a notation vote item and focus on issues needing modification by requesting comment rather than trying to settle every aspect of the whole rule at this time. The Chairman requested Commissioners to submit their notation votes within 10 days.
(OCM) (SECY Suspense: 4/1/85)
E n'd T C} , g g 'N.
C M. ...
Tii.: . . . ./.
?h . .h. . . . . . .wm
........a
- Commissioner Roberts was not present.
D f G ([]
cc: Chairman Palladino Commissioner Roberts Commissioner Asselstine Commissioner Bernthal Commissioner Zech Commission Staff Offices PDR - Advance DCS - 016 Phillips
-- e. c-- c w