ML19347D450
| ML19347D450 | |
| Person / Time | |
|---|---|
| Issue date: | 03/05/1981 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| Shared Package | |
| ML19247D045 | List: |
| References | |
| REF-10CFR9.7 SECY-79-542, SECY-80-545, SECY-81-094, SECY-81-94, NUDOCS 8103170668 | |
| Download: ML19347D450 (5) | |
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NATIONS 1 UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION I
3 4
l AFFIRMATION SESSION 81-9 i
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8 Nuclear Regulatory Commission d
Room 1130 d
9 1717 H Street, N.W.
I Washington, D.C.
h, 10 i
Thursday, March 5, 1981 E
11 5
y 12 The Commission met, pursuant to notice, at 4:11 p.m.,
E mr 13 JOSEPH M. HENDRIE, Chairman, presiding.
14 PRESENT:
5 2
15 JOSEPH M. HENDRIE, Chairman 5
16 VICTOR GILINSKY, Commissioner dw d
17 PETER A. BRADFORD, Commissioner I
18 JOHN F. AHEARNE, Commissioner E[
19 STAFF PRESENT:
M 20 LEONARD BICKWIT, General Counsel 21 SAMUEL J. CHILK, Secretary CT_
22 l
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25
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ALDERSON REPORTING COMPANY. INC.
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of de fo =al or ' 3 :=al. scord of decision. of -la =a::ars disc =ssed.
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Ne p' andd ? or other paper =ay be. filad vi:1 -le C--
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a Il PRggg{Diggg l-l CHAIRMAN HENDRIE:
Sam?
2 3
MR. CHILK:
The first paper is 3ECY-81-94 The I
4 Commission has unanimously approved publication in the
~
e 5
Federal Register of the Proposed Notice of Intent to retain "nj 6
the existing regulations on the treatment of cardiac R
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7 dysfunction by iodine-131.
~nj 8
Will you please affirm your vote?
dd 9
(CHORUS OF AYES.)
t 10 CHAIRMAN HENDRIE:
In order to take up the second 45 g
11 item, I need votes to hold a short notice affirmation session b
g 12 to consider SECY-80-545, NRC Rulemaking to implement EPA's
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N 13
" Environmental Radiation Protection Standards for Nuclear l
14 Power Operations," (40 CFR Part 190).
4 2
15 All in favor, so indicate, i
f 16 (CHORUS OF AYES.)
w 6
17 CHAIRNMN HENDRIE:
So ordered.
5 18 MR. CHILK:
SECY-80-545; the Commission has 19 unanimously approved final amendments to 10 CFR Part-20 e
a 20 incorporating the requirement to comply with EPA's 40 CFR t
21 l
Part 190, with an OGC footnote approved by all of you.
r, 22 i
Will you please affirm?
.=
23 ;
(CHORUS OF AYES.)
3 Vsii 24j CHAIRMAN HENDRIE:
So ordered.
Thank you very much.
.=
5 25l (The affirmation session adjourned at 4:15 p.m.)
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J ALDERSON REPORTING COMPANY. INC.
l NUCLEAR REGULATORY CO.5dMISSION e
This is to certify that the attached p."oceedings before the 7
c' COMMISSION MEETING in the matter of:
Affirr.ation Session 81-9 Date of Proceeding:
March 5, 1981 Docket flu =ber:
Place of Proceeding: Washinoton, D. C.
wore held as herein appears,.and that this is the original transcript thereof for the file of the Con =ission.,
Marilyn Nations Official Reporter (Typed)
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Official' Reporter (Signature) e y.
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SECY-81-94 February E,1981
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QM RULEMAKING ISSUE (Affirmation)
For:
The Comissioners From:
William J. Dircks, Executive Director for Operations 4
Subject:
THERAPEUTIC TREATMENT OF CARDIAC DYSFUNCTION BY 10 DINE-131
Purpose:
Approval of the publication of a Federal Register Notice, for public comment, indicating NRC's intent to unconditionally retain the therapeutic treatment of cardiac dysfunction by iodine-131 in the regulations.
Category.
This paper covers a minor policy question.
Issue:
Should NRC continue to. allow physicians to use iodine-131 for the therapeutic treatment of cardiac dysfunction although the Food and Drug Administration (FDA) has reclassified this treatment as lacking substantial evidence of effectiveness?
Alternatives:
1.
Publish for public coment in the Federal Register a notice of NRC's intent to delete the therapeutic treatment of l
cardiac dysfunction by iodine-131 from NRC regulations.
2.
Publish for public coment in the Federal _ Register a notice of NRC's intent to unconditionally retain the therapeutic treatment of cardiac dysfunction in the regulations.
3.
Publish for public coment in the Federal Register a notice of NRC's intent to retain the therapeutic treatment of car-diac dysfunction in the regulations, but limit its application to such cases where it is the preferred treatment and patient benefit far exceeds the risk.
Discussion:
In the Comission's February 21, 1980 action on SECY-79-542 (Therapeutic Treatment of Cardiac Dysfunction), the Comission deferred action on the staff's recommendation to publish a Federal Register Notice (FRN), for public coment, indicating NRC's intent to retain the therapeutic treatment of cardiac dysfunction in the regulations pending receip
Contact:
DUPLICATE DOCUMENT 0
4 0
Entire document previously entered into system under:
EldnXbit3
^NO N o. of pages:
7 s
i
September 20, 1979 SECY-79-542 i
Fer:
The Commissioners Fro 2:
Robert B. Minogue, Director Office of Standards Development Thru:
Executive Director for Operations M ptvj
Subject:
THERAPEUTIC TREATMENT OF CARDIAC DYSFUNCTION BY 10 DINE-131
Purpose:
To obtain Commission approval of a Federal Register Notice of NRC's intent to retain the therapeutic treatment of cardiac dysfunction in the regulations.
Category:
This paper covers a minor policy question.
Issue:
Should NRC continue to allow physicians to use iodir.e-131 for the therapeutic treatment of cardiac dysfunction since the Food and Drug Administration has reclassified this treatment as lacking substantial evidence of effectiveness?
Alternatives:
1.
Deletet[etherapeutictreatmentofcardiacdysfunctionby iodine-131 from NRC regulations.
2.
Publish for public comment in the Federal Register NRC's intent to retain the therapeutic. treatment of cardiac dysfunction in NRC regulations (a minor exception to the Medical Policy Statement).
3.
Change the Medical ' Policy Statement's handling of the therapeutic uses of radionuclides to allow for exceptions as regards FDA appro Discussion:
Background
I NRC's Medical Policy Statement specifies regulatory policy for restricting the uses of therapeutic radioactive drugs to the clinical i
procedures that have been approved by the Food and Drug Administration.
In 1976, FDA reclassified tion by iodine-131 as 1 DUPLICATE DOCUMENT Entire document previously entered into system under:
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! itaf [i 5 [i(L SECY-80-545 December 19, 1980_
RULEMAKING ISSUE The Commis(sionersAffirmation)
For:
From:
William J. Dircks, Executive Director for Operations
Subject:
NRC RULEMAKING TO IMPLEMENT EPA'S " ENVIRONMENTAL RADIATION PROTECTION STANDARDS FOR NUCLEAR POWER OPERATIONS" (40 CFR 190)
Purpose:
To obtain Commission approval of final amendments to 10 CFR Part 20 incorporating the requirement to comply with EPA's 40 CFR Part 190.
Category:
Minor policy question requiring Commission approval.
Discussion:
On March 19, 1980, the Commission approved proposed amend-ments to 10 CFR Part 20 (SECY-80-54, January 28,1980),
which were published for public comment on April 17, 1980 (Enclosure "A").
As discussed in SECY 80-54, the amend-met;ts would incorporate into NRC regulations the existing EPA requirement that certain fuel cycle licensees comply with EPA's " Environmental Radiation Protection Standards for Nuclear Power Operations" (40 CFR Part 190).
The EPA regulation restricts radioactive releases and doses to the public from most fuel cycle operations.
NRC licensees affected by 40 CFR Part 190 include uranium mills, uranium hexafluoride plants, commercial uranium fuel fabrication plants, and power reactors.
Public comments:
Four sets of minor comments were received l
on the proposed amendments.
These are discussed in the proposed FEDERAL REGISTER Notice (Enclosure "B").
No signi-ficant adverse comments or questions were received during the comment period. We recomnend that the amendments be published in final form as proposed, with one minor change.
The change clarifies that if a licensee submits to NRC a report of excess radioactive releases, the description of j
corrective steps planned shall include the schedule for achieving conforman
~ ted license conditions.
l DUPLICATE DOCUMENT The EDO is authoriz where no significan Entire document previously the notice of propo entered into system under:
Mining Congress and I/ // H b((
AE recently submitted I
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'M No. of pages:
Contact:
443-5966
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