ML20210F542
| ML20210F542 | |
| Person / Time | |
|---|---|
| Issue date: | 07/19/1999 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Bailey E CALIFORNIA, STATE OF |
| Shared Package | |
| ML20210F548 | List: |
| References | |
| NUDOCS 9908020035 | |
| Download: ML20210F542 (8) | |
Text
? , Mr. Edgar D. Bailey,' Chief i *'
- Rcdi: logic Health BrInch ' .
D Divisiin of Food, Drug & ReLi: tion Safety. M I $ 1999 -
California Department'of Health Services l P. O. Box 942732 =
l , Sacramento, CA 94234-7320
Dear Mr. Bailey:
As requested, we have reviewed the proposed regulations, $30210.2, Labeling Requirements y for the Manufacture, Preparation or Transfer for Commercial Distribution of Drugs Containing Radioactive Material for Human Use as Authorized by a Specific License, (R-12-98), dated April 14,1999.> The proposed regulations are in response to the one amendment identified in the enclosed Regulation Assessment Tracking System (RATS) Data Sheet. The regulations were reviewed by compar3on to the equivalent NRC regulations in 10 CFR Part 32.72. We
' discussed our review with David Wheeler on June 24,1999.
l As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our cuirent procedure, a l finding that a State regulation meets the compatibility and health and safety categories of the L equivalent NRC regulation may only be made based on a review of the final State regulation.
l
' However, we have determined that if your proposed regulations were adopted without significant change, they would meet the compatibility and health and safety categories established in OSP Procedure SA-200.
[ We request that when the proposed regulations are adopted and published as final regulations,
' a copy of the "as published" regulations be provided to us for review. As requested in OSP Procedure SA-201, Review of State Reaulations (November 10,1998), please highlight the final l changes and send one copy in a computer readable format, if possible. !
l We have also summarized on the RATS Data Sheet our knowledge of the status of other California regulations. Please let us know if you note any inaccuracies or have any comments l on the information contained in the RATS Data Sheet.
l
~
if you have any questions regarding the comments, the compatibility and health and safety :
categories, or any of the NRC regulations used in the review, please contact me or Linda 1 McLean at (817) 860-8116 or mimienrc.aov. ;
i Sincerely' MUY' l PAULH.IJOHAUS l Paul H. Lohaus, Director L Office of State Programs
Enclosure:
J As stated
'- Distribution:
)
DIR RF (9-124)
SDroggitis L
DCD (SP08)
PDR (YES/) -
- )
L _ DChambertain BUsilton.-
Crlifornia File l DOCUMENT NAME: G:\SNS-CA REVIEW 99.WPD . *See previo9s concurrence. I Ta receive a cap r of Wiis teocunnent, inecate in the t,om: "C" = Copy tulthout attachment /onolosure "E"
- Copy vulth att-
- T[/ _ "N" = No copy ,
OFFICE RIV:SAO -l OSP l- OGC- l- OSPf$h/ l l ;
NAME' MLMcLean:gd:kk SNSalomon SATreby PHLohdf )
DATE 06/23/99* 06/29/99* 07/15/99* 07/ J /99 ;
9908020035 990719 m OSP FILE CODE: SP-AG-4 PDR STPRO E80CA O,
aeg y k UNITED STATES g
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2006H001 l
l
%..... July 19, 1999 Mr. Edgar D. Bailey, Chief Radiologic Health Branch Division of Food, Drug & Radiation Safety Californb Department of Health Services P. O. Box 942732 Sacramerlo, CA 94234-7320 Det Mr. Ba' ley:
As requeste.d, we have reviewed the proposed regulations, $30210.2, Labeling Requirements for the Manufacture, Preparation or Transfer for Commercial Distribution of Drugs Containing Radioactive Material for Human Use as Authorized by a Specific License, (R-12-98), dated April 14,1999. The proposed regulations are in response to the one amendment identified in the enclosed Regulation Assessment Tracking System (RATS) Data Sheet. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 32.72. We discussed our review with David Wheeler on June 24,1999.
As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation.
However, we have determined that if your proposed regulations were adopted without significant ;
change, they would meet the compatibility and health and safety categories established in OSP l
Procedure SA-200. 4 We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in OSP Procedure SA-201, Review of State Reoulations (November 10,1998), please highlight the final changes and send one copy in a computer readable format, if possible. .
I We have also summarized on the RATS Data Sheet our knowledge of the status of other l California regulations. Please let us know if you note any inaccuracies or have any comments on the information contained in the RATS Data Sheet. l
)
If you itave any questions regarding the comments, the compatibility and health and safety j categories, or any of the NRC regulations used in the review, please contact me or Linda l McLean at (817) 860-8116 or mimianre cov.
Si c rely , l
) I p.\ [M haul H. Lohaus, Director Office of State Programs
Enclosure:
As stated J
REGULATION ASSESSMENT TRACKING SYSTEM RATS DATA SHEET State: California Tracking Ticket Number: 9-124
[one proposed amendment (4/14/99) identified by*) Date: July 19, 1999 NRC Chronology identification FR Notice RATS ID Proposed / NRC Final (State Due Final-Comment Review Regulation Date) (Y/N) Date (Effective Date)
Standards for Protection Against Radiation- 56 FR 23360 1991 3 FN 10/25/97 3/3/94 PIrt 20 plus others (1/1/94)
Safety Requirements for Radiographic 55 FR 843 1991 1 P-N 7/24/97 Equipment- (1/10/94)
Part 34 ASNT Certification of Radiographers-Part 34 56 FR 11504 1991-2 Not (none) required Notification of incidents-Parts 20,30,31,34, 56 FR 64980 1991-4 F-N 4/1/98 9/9/97 39,40,70 (10/15/94)
Quality Management Program and 56 FR 34104 1992-1 Misadministrations- (1/27/95) ,
Part 35 I Eliminating the Recordkeeping Requirements 57 FR 45566 1992-2 Not for Departures from Manufacturer's (none) required instructions-Parts 30,35 Licensing and Radiation Safety Requirements 58 FR 7715 1993-2 for Irradiators-Part 36 (7/1/96)
Definition of Land Disposal and Waste Site 58 FR 33886 1993-3 QA Program-Part 61 (7/22/96)
D: commissioning Recordkeeping and License 58 FR 39628 1993-1 P-N 1/22/97 j Termination: Documentation Additions (10/25/96) l
[ Restricted areas and spill sites}-Parts 30,40 Self-Guarantee as an Additional Financial 58 FR 68726 1994-1 F-N 4/1/98 9/9/97 Mechanisn> Parts 30,40,70 59 FR 1618 (1/28/97)
Uranium Mill Tailings Regulations: Conforming 59 FR 28220 1994-2 Not NRC Requirements to EPA Standards-Part 40 (7/1/97) required Timeliness in Decommissioning Material 59 FR 36026 1994-3 Facilities- (8/15/97)
Parts 30,40,70
- Preparation, Trar'sfer for Commercial 59 FR 61767 1995-1 P-N 7/19/99 Distribution, and Use of Byproduct Material for 59 FR 65243 Msdical Use- 60 FR 322 Parts 30,32,35 (1/1/98)
Fr:qusney of Medical Examinations for Use of 60 FR 7900 1995-2 Respiratory Protection Equipment-Part 20 (3/13/98)
L 'NRC, Chronology identification N FR Notica f , , : RATS,ID . Proposed / NRC Final .-
!- T ,
j - ,
4 j(State Due c ,
Final-Comment R: view 1 R:gul tion l
- N , ,c N, .7M -- &J- ,
,'< ,v,j 10ste); ,
,m ,,
e, ,
(M)L-4 Date : (Effective ?
>e D M :'
Low-LevelWaste Shipment Manifest _ 60 FR 15649 1995-3 i . Information and Reporting-Parts 20,61 60 FR 25983 (3/1/98)
PJrformance Requirements for Radiography 60 FR 28323 1995-4 l Equipment- Part 34 (6/30/98) l Radttion Protection Requirements: Amended 60 FR 36038 1995-5 Definitions and Criteria-Parts 19,20 (6/14/98)
Clarification of Decommissioning Funding 60 FR 38235 1995-6 F-N 4/1/98 0/0\9/97 R:quirements-Parts 30,40,70 (11/24/98) l Medical Administration of Radiation and 60 FR 48623 1995-7 l Radioactive Materials-Parts 20,35 (10/20/98) 10 CFR Part 71: Compatibility with the 60 FR 50248 1996-1 ,
l Int:mational Atomic Energy Agency-Part 71 61 FR 28724 l l (4/1/99) 1 l
One Time Extension of Certain Byproduct, 61 FR 1109 1996-2 Not Source and Special Nuclear Materials (none) required l
Licenses-Parts 30,40,70 l- Termination or Transfer of Licensed Activities: 61 FR 24669 1996-3 l Rscordkeeping Requirements-Parts 20,30, - (6/17/99) 40,61,70 R:s:lution of Dual Regulation of Airbome 61 FR 65119 1997-1 Effluents of Radioactive Materials; Clean Air (1/9/00)
Act-Part 20 l F!:sile Material Shipments and Exemptions-
- 62 FR 5907 1997-4 Not i
Part 71 (none) required Rrcognition of Agreement State Licenses in 62 FR 1662 1997-2 Areas Under Exclusive Federal Jurisdiction (2/27/00)
Within an Agreement State-Pr.:t 150 l
l CritIria for the Release of Individuals 62 FR 4120 1997 3 i l Administered Radioactive Material-Parts 20, (5/29/00) 35 Licenses for industrial Radiography and 62 FR 28948 1997 5 Radttion Safety Requirements for industrial (6/27/00)
Radiography Operations-Parts 30,34,71,150 Radiological Criteria for License Termination- 62 FR 39057 1997-6 Parts 20,30,40,70 (8/20/00)
Exempt Distribution of a Radioactive Drug 62 FR 63634 1997-7 C:ntaining one Microcurie of Carbon-14 (1/2/01)
Urea Part 30 Deliberate Misconduct by Unlicensed 63 FR 1890 1998-1 Persons- 63 FR 13773 P:rts 30,40,61,70,150 (2/12/01)
E' NRC' Chronology identification 1 ', FR 'Notic 3 si: L . RATS ID. Proposed / ? NRC. Final . l m
- q. ,' (State Duei . ,
4 FinakComment - R; view ' H:guluion Q M
-y.p- , Date) ,
(YSI)!- Date (Effective :
Date) -
Self-Guarantee of Decomrnissioning Funding 63 FR 29535 1998-2 Not I by Nonprofit and Non-Bond issuing ' (none) required l Licensees.
Parts 30,40,70 License Term for Medical Use Licenses- 63 FR 31604 1998-3 Not Part 35 (none) required Licenses for Industrial Radiography and 63 FR 37059 1998-4 Radiation Safety Requirements for industrial (7/9/01)
Radiographic Operations-Part 34 Minor Corrections, Clarifying Changes, and a 63 FR 39347 1998-5 Minor Policy Change-Parts 20,35,36 63 FR 45393 (10/26/01)
Transfer for Disposal and Manifests: Minor 63 FR 50127 1998-6 Ttchnical Conforming Amendment-Part 20 (11/20/01) l
)
)
I i
. . . Mr. Edgar D. 8 iley, Chief Rcdiologic Health Branch Divisi:n of Food, Drug & R di; tion Safety
( California Department of Health Services P. O. Box 942732 Sacramento, CA 94234-7320
Dear Mr. Bailey:
~ As requested, we have reviewed the proposed regulations $30210.2, Labeling Requirements for the Manufacture, Preparation or Transfer for Commere al Distribution of Drugs Containing Radioactive Material for Human Use as Authorized by a ecific License, (R-12-98), dated April 14,1999. The proposed regulations are in respons to the one amendment identified in the enclosed Regulation Assessment Tracking System ( ATS) Data Sheet. The regulations were reviewed by comparison to the equivalent NRC regplations in 10 CFR Part 32.72. We discussed our review with David Wheeler on June 24,1 9.
As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and fafety. Under our current procedure, a finding that a . State regulation meets the compatibility apd health and safety categories of the equivalent NRC regulation may only be made based og a review of the final State regulation.
However, we have determined that if your proposed reputations were adopted without significant change, they would meet the compatibility and health and safety categories established in OSP Procedure SA-200.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as publis't:d" regulations be provided to us for review. As requested in OSP Procedure SA-201, Review of State Reoulations (November 10,1998), please highlight the final changes and send one copy in a computer readable f' ormat, if possible.
We have also summarized on the RATS Data Shee our knowledge of the status of other California regulations. Please let us know if you nofe any inaccuracies or have any comments on the information contained in the RATS Data Sheet.
If you have any questions regarding the commenta the compatibility and health and safety categories, or any of the NRC regulations used in fhe review, please contact me or Linda McLean at (817) 860-8116 or mimienre cov. I I
I ,
Sine rely, '
PauJ H. Lohaus, Director Office of State Programs Encles are:
As stated i Distribution:
DIR RF (9-124) DCD (SP08)
SDroggitis PDR (YES/)
DChimberlain BUsilton Cclifornia File DOCUMENT NAME: G:\SNS-CA REVIEW 99.WPD 'See prevlogs concurrence.
Ts receive a cop, of this document, indicate in the box: "C" = Copy without attachment / enclosure *E' = Copy with attachmeQ
/ Mure *N' = No copy OFFICE RIV:SAO OSP bQGGa OSP$[f/] [
NAME MLMcLean:gd:kk SNSalomon SAfrebyf PHLohdd '
DATE 06/23/99* 06/29/99* , 07/6 /99 07/ ) /99 OSP i 4LE CODE: SP-AG-4
Edg:r D. Bailey, Chief . .
Radiologic He:lth Branch Stata of Cilif:rni2 Department of Health Services P. O. Box 942732, MS-7320 Sacramento, CA 94234-7320
Dear Mr. Bailey:
' As r'equested, we have reviewed the proposed regulat:ons R-12-98), Title 17. Public Health;
. Division 1. Department of Health Services; Chapter 5. Sa ation; Subchapter 4. Radiation; Group 2.' Licensing of Radioactive Materials; Article 5. Tr sfer of Material dated April 14,1999.
The proposed regulations are in response to the one am dment identified in the enclosed Regulation Assessment Tracking System (RATS) Data eet. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 FR Part 32.72. We discussed our review with David Wheeler on June 7,1999. -
~
As a result of our review, we have no comments. Plea note that we have limited our review to regulations reouired for compatibility and/or health an safety. Under our current procedure, a
~ finding that a State regulation meets the compatibility nd health and safety categories of the equivalent NRC regulation may only be made based n a review of the final State regulation.
However, we have determined that if your proposed gulations were adopted without significant change, they would meet the compatibility and healt L and safety categories established in OSP Procedure SA-200.
We request that when the proposed regulations ar adopted and published as final regulations, a copy of the "as published" regulations be provid to us for review. As requested in OSP Procedure SA-201, Baview of State Reaulations ( ovember 10,1998), please highlight the final changee and send one copy in a computer reada le format, if possible.
' We have also summarized on the RATS Data S eet our knowledge of the status of other California regulations.' Please let us know if yo note any inaccuracies or have any comments on the information contained in the RATS Data heet.
- If you have any questions regarding the com nts, the compatibility and health and safety categories, or any of the NRC regulations u in the review, please contact me or Linda McLean at (817) 860-8116 or mim18nrc cov incerely, Paul H. Lohaus, Director OW- State Programs
Enclosure:
As stated '
Distnbution-DIR RF , DCD (SP03)
SDroggitis . ,
PDR (YES/)
DChimberlain BUsilton
' C:lifornia File DOCUMENT NAME: G:\SNS-CA REVIEW 99. D
. Tt feceive a cess ' of this document, indicata in the bos: "C" = Copy - attachment / enclosure "E" = Copf with attachment / enclosure "N" = No copy OFFICE RIV:SAOfME. OSPb"Qls OGC l OSP:D l l l NAME MLMcLean:gd SNSalomon / SATreby PHLohaus
{ DATE 06/ $9 06 @99 06/ /99 06/ !99 OSP FILE CODE: SP-AG-4 L
. 2 q- 04 I'
FAX INFORMATION 1
PLEASE FORWARD IMMEDIATELY l
l' U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS l STATE PROGRAMS FAX: (301) 415-3502 i NUMBER OF PAGES: 4 DATE: June 9,1999 TO: Linda McLean !
FAX: 817-860-8288 Phone: 817-860-8116 FROM: Stephen N. Salomon Phone: 301-415-2368 MESSAGE: Attached is letter 6/2/99 from Ed Bailey re !
proposed reg review (RATS-1995-1). Please review for response by 7/19/99. Should take less than one hour.
i l
l