ML20199E623

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Staff Requirements Memo Re SECY-97-232, Final Rule on Exempt Distribution & Use of Radioactive Drug Containing One Uci of C-14 Urea, & SECY-97-288, Final Amends to 10CFR73, to Change Certain Physical Security Requirements
ML20199E623
Person / Time
Issue date: 11/05/1997
From: Hoyle J
NRC OFFICE OF THE SECRETARY (SECY)
To: Callan L
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20199C336 List:
References
FRN-62FR63634, REF-10CFR9.7 AF70-2-006, AF70-2-6, AF70-6, M971105B, SECY-97-228-C, SECY-97-232-C, NUDOCS 9711210267
Download: ML20199E623 (5)


Text

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[ pes; UNITED STA1 ES p" oj; NUCL EAR REGULATORY COMMISSION g gl .WASHINGTON, O C. 20555 0001-

% 8' IN RESPONSE,-PLEASE REFER TO:~ M971105B 4.... ' _ November 5 1997'

'6ECRETAHY' MEMORANDUM FOR: L. Joseph Callan .

Execu ve-Directoy for Operations j?-a f -

FROM: Joh .Hb[16,S ary

SUBJECT:

ST[IFREQUIREMENTS-AFFIRMATIONSESSION,

'11:30 A.M., AND 3:00 P.M., WEDNESDAY, NOVEMBER 5, 1997, COMMISSIONERS' CONFERENCE ROOM, ONE-WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)

L 11:30 A.M.-Session

.l.

SECY-97-232 - Final Rule on Exepot Distribution and Use of a Radioactive Drua Containina OneJMicrocurie of Carbon 14 Urea (Parts 30 and 32)

The. Commission approved a final rule amending 10 CFR Parts 30 and 32 to pern.it the exempt distribution and use of capsules containing one microcurie carbon-14 urea for "in vivo" diagnostic use. The staff should incorporate the followina comments and the editorial changes provided in the attachm,nt.

The staff response to comment 3 should be reviewed and revised by a staff Health Physicist with expertise in radiological assessments to ensure it accurately and clearly responds to che comment.

The Health and Safety Effects section of the Regulatory Analysis should be revised to clarify that individual and collective dose estimates do not consider the radiation dose received bv the patient, and that the collective dose of 5 person-rem over a 50 year: period discussed-in paragraph'4 is not an annual dose.

Following acorporation of these comments and the editorial changes provided in the attachment, the Federal Rec'ister notice should be reviewed by the Rules Review and Directives Branch in

-the-Office of Administration and forwarded to the Office of the Secretary for signature and publication.

. (EDO)- (SECY Suspense: 12/5/97) 9711210267 971105 -

'PDR COMMS NRCC a

? CORRESPONDENCE r

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l B. 3:00 P.M. Session 12 SECY-97-228 - Final Amendments to 10 CPR Part 73. " Chances to Nuclear Power Plant Security Recuirements" The Commission approved a final rule amending 10 CFR Part 73 to change certain physical security requirements associated with an internal threat. The staff should coordinate the finalizatica of the public announcement with the Office of Public Affairs and issue a press release related to this rulemaking.

Following incorporation of the editorial changes provided in the attachment, the Federal Reaister notice should be reviewed by the Rules Review and Directives Branch in the Office of Administration and forwarded to the Office of the Secretary for signature and publication.

(EDO) (SECY Suspense: 12/5/97)

Attachments:

As stated 1

cc: Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan EDO OGC CIO CFO OCAA OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR - Advance DCS - P1-17 l

l

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I. Editorial Changes to the Final Rule in SECY-97-232 I

l l Changes to the Federal Reaister Notice

1. On page 1,line 4 replace 'a minimal' with 'an insignificant.'
2. On page 9, paragraph 2, line 8, delete the 's' on

' procedures.'

3. On page 12, paragraph 1, line 6, delete 'nothing will prevent' and insert 'are not required to' after

' manufacturers.' Also, delete 'from' and replace

' indicating' with ' indicate.'

4. On page 13, paragraph 2, line 1, replace 'no significant' with 'an insignificant.' In line 2, replace 'or' with

'and.'

5. On page 14, item (2), line 2, replace 'be prohibited by this rulemaking' with ' continue to require a specific license pursuant to Part 35 under this rulemaking.'
6. On page 14, last paragraph, line 5, delete the comma.
7. On page 16, last paragraph, line 2, delete 'not' and in line 3, replace 'significant' with ' insignificant.'
8. On page 22, paragraph 1, line 4, replace 'no significant' with ' an insignificant . '

Changes to the Regulatory Analysis

1. On page 3, paragraph 5, line 6, replace 'a minimal' with 'an insignificant.'
2. On page 7, first full paragraph. line 13, replace 'or' with

'and.' Also, add at the end of the paragraph: The routine exposure of patients was not considered when calculating the individual or collective doses resulting from the diagnostic tests.

3. On page 1, last paragraph, line 5, delete ' annual' and on in line 6, delete 'next.' Also in line 6, delete the 's'

' years' and insert ' period' af ter ' year. '

4. On page 8, last paragraph, last line, replace ' negligible' with ' insignificant . '

Changes to the Environmental Assessment

1. On page 1, paragraph 1, line 4, replace ' a minimal' with ' an insignificant.'

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2. On page 1, paragraph 2, line 4, replace ' negligible' with

'insignificanc.'

3. On page 2, paragraph 2, line 7, rep?. ace 'a minimal' with 'an insignificant.'
4. On page 2, last paragraph, line 1, replace 'no significant' with ' an insigitificant. '
5. On page 3, paragraph 2. add at the end of the paragraph:

This is far below the EPA reporting level of 1 mrem / year required under tb,3 Clean Air Act for routine exposures to a member of the public, and the 4 mrem / year EPA limit for public drinking water.

6. On'page 4, last paragraph, line 9, replace 'a minimal' with

'an insignificant.'

Changes to the Congressional Letters

1. In paragraph 2, line 5, replace 'a minimal' with 'an insignificant.'

Changes to the :rublic Announcement

1. On page 1, paragraph 3, lines 4 and 5, replace 'a minimal' with 'an insignificant' and insert ' diagnostic use of the' before ' drug.'
2. On page 2, paragraph 1, line 5, the 'C' in ' carbon-14' should be lower case.

_______-__-___-________-_L __ __ _

Editorial' Changes to the Final Rule in SECY-97-228

- Changes to the Federal Reaister nctice:

1. On page 2, paragraph 1,'line-2., replace ' revising' with

'that would_ revise.' In line 6, replace 'are as follows' with ' involve changes to.'

Or page 5, paragraph 2, line 4, insert 'who are cleared for

~

2.-

unescorted access' after ' employees.' In paragraph 3, line 4,- replace ' discriminate' with ' distinguish. ' In .he last paragraph, line 3, replace 'of these' with 'commenter.'

On page 8, paragraph 2 under. item 5, line 2, replace

- 3.

' making' with ' make' and in line 4, insert a comma after

' been .

4. On page 11, last line, replace ' assume' with ' assuming.'

Changes to the Congressional letters:

In line 1, replace the last the' - with 'an' so that it reads 1.

... copy of an amendment to ....'

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