ML20211K043
| ML20211K043 | |
| Person / Time | |
|---|---|
| Issue date: | 10/03/1997 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Aldrich R NEW YORK, STATE OF |
| References | |
| NUDOCS 9710090107 | |
| Download: ML20211K043 (5) | |
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- DCT ~8 167 Ms. Rita Aldrich, Principal Radiophysicist -
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- Radiological Health Unit _
- Division of Safety and Health
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-New York State Department of Labor a
NYS Office Campus, Bldg.12, Room 457 '
e Albany, NY ' 12240
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Dear Ms. Aldrich:
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-This is in reference to your Septembe/ 2, '997 letter with comments on the revision to Management Directive 5.6 (MD 5.6), "!ntegrated Materlat Performance Evaluation-Program." We appreciate receiving your comments. We were not able to include your -
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- comments in our analysis and final MD 5.6. As we stated !n'our All Agreement States Letter, SP 97 053, we needed comments by August 27,1997 to _ meet a Commission assigned due date of August 29,1997 to prepare MD 5.6 in final. 'Your comments'were dated September 2,1997 and were received by our office on September 8,1997. Upon i
receipt of your comments, our finalization of MD 5.6 had been completed.
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_ However, several of the issues you raised concerning the non-common performance Indicator, Sealed Source and Device Evaluation Program, were also made by other
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Agreement States. Based on the comments received, revisions were made to this.
indicator. We will consider your comments during our next revision to MD 5,6. If you 4-have any questions, please contact me at 301415-3340 or Kathleen Schneider at 301-415 2320.
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Sincerely, L
RT Richard L. Bangart, Director Office of State Programs m-9710090107 971003 PDR STPRQ ESONY PDR
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- SDroggitis PDR (YES1c NO,_)
Management Directive File l
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- DOCUMENT NAME:- G:\\KXS\\ALDRICK.KNS
. 'See previous concurrence.
T3,eeelve a sepy of this clocument,ineNeste in the bos: *C* = Copy without attachment / enclosure
- E' = Copy with attachment / enclosure
- N* = No copy OFFICE
.OSP l
OSP M l OSP:D gg l-l NAME KSchneider:nb:kk PHLoh @p RLBangart 'Vir 8
p6T 3/97 DATE
-09/24/97*
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UNITED STATES i
l NUCLEAR REGULATORY COMMISSION s*
WASHINGTON D C. W0eeH001
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October 3, 1997 l
Ms. Rita Aldrich, Principal Radiophysicist Radiological Health Unit Division of Safety and Health New Yo t State Department of Labor NYS Office Campus, Bldg.12, Room 457 Albany, NY 12240
Dear Ms. Aldrich:
This is in reference to your September 2,1997 letter with comments on the revision to Management Directive 5.6 (MD 5.6), " integrated Material Performance Evaluation Program." We appreciate receiving your comments. We were not able to include your comments in our analysis and final MD 5.6. As we stated in our All Agreement States Letter, SP 97 053, we needed comments by August 27,1997 to meet a Commission assigned due date of August 29,1997 to prepare MD 5.6 in final. Your comments were dated Septernber 2,1997 and were received by our office on September 8,1997. Upon receipt of your comments, our finalization of MD 5.6 had been completed.
However, several of the issues you raised concerning the non-common performance indicator, Sealed Source and Device Evaluation Program, were also made by other Agreement States. Based on the comments received, revisions were made to this indicator. We will consider your comments during our next revision to MD 5.6. If you have any questions, please contact me at 301-415-3340 or Kathleen Schneider at 301-415 2320.
Sincerely, ll((
1 h Richard L. Bangart, Directo '
Office of State Programs i
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De.0SPbR) ga w STATE OF NEW YORK g//L g
DEPARTMENT OF LABOR acp DIVISION OF SAFETY AND HEALTH KX.5 Radiological Health Unit Building #12, Room 134.A State Office Building Campus co Albany, NY 12240 C@
September 2,1ri"3 EO E~
Richard L. Bangart, Director p
Office of State Prograrns y
03D23 N
Nuclear Regulatory Commission Washington, DC 20555-0001 Re:
Comments on Management Directive 5.6 "IMPEP"
Dear Mr. Bangart:
Enclosed find our comments on the revision of Management Directive 5.6, "IMPEP". Although the August 27 deadline has passed, we trust that it is still not to late to have them included.
Thank you for the opportunity for input into this process.
Sincerely, e
Rita Aldrich Principal Radiophysicist Enclosure (1) cc; Heidi Voelk - NYSERDA 1
i 99-M Telephone: 616-4571202 FAX 016-457-0545 C' O#116014 V
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New York State 4
Department of Labor.
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Memo 1
j To:
Rita Aldrich From Clayton Bradth Date:
09/02/97 Re Comments on NRC Management Direc0ve 5.6 (IMPEP)
Part il C - Non common Performance Indicators 1
(2)
Non-common Performance Indicator 2 - SS&D Evaluatkin Program 4
l Comments j
1.
The footnote at the bottom of page 4 of Handbook 5.6 states that Agreement States with authority for Sealed Source and Device Evaluation Programs will need to have a program in place, regardless of whether or not it is perfctrning SS&D reviews. This amounts to NRC requiring States to establish phantom programs, which ar.ist only on paper. How is NRC to determine if a prog sm is "in place "if no SS&D reviews have been performed? What evidenes cou!d NRC require of a State to demonstrate the existence of a program that produces no product? This is a pointless requirement since all a State need do is claim to have -a program, and NRC can not refute it. It.is also inconsistent sinco no similar requirement is made for Non-Common Performance Indicator 3 - Low level radioactive Waste Disposal Program.
States who have no Disposal facilities are (appropriately) not expected to have a Low Level Radioactive Waste Disposal Program "in place". The NRC should not treat the State's SS&D Evaluation Programs differently without having first demonstrated a valid reason for doing so.
2.
Paragraph 1. (a) - Technical Quality of the Product Evaluation Program, states that vendors' quality assurance and control programs should be evaluated as part of the SS&D review. This is properly a licensing function and should not be duplicated by the SS&D evaluation for each new product.
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i ll No vendor should be issued a license to manufacture and distribute devioos containing radioactJve material without first demonstrating en odoquete QA/QC program is in pisca, in which case, the person performing an SS&D review need only check to be sure that the applicent has a mank.aduring and distribution license; the presence of an adequate QA/QC program can then be assumed. To require a review of a licensee's manufeduring QA/QC program during each product review is needlessly duplicative.
3.
2 (b) Technical Staffing and Training NRC has established no specific qualmestions, for those staff who perform l
SS&D reviews, over and above the qualifications required for other technical staff. There are no core coursos offered or even recommended by NRC for SS&D reviewers. It is therefore impossible for an Agreement State to determine verf constitutes the
- proper training and quelmoetions" required to obtain a satisfactory evaluation by the IMPEP review team.
Part lli Evaluation Criteria 4.
The evaluation criteria for Non common Perfonnance ' Indicator 2 include, c'er Technical Quality, the requirement that an independent technical review t.< ;erlormed by a second reviewer. Th!s Is an unjustified duplication. No weh independent review is required for licensing edions, which are far more critical to protecting heaPh and safety than product reviews. States do not i
have the resources to commit two sta3 to each and every SS&D review A reasonable requirement would be for a second reviewer to check the initial review for completen6ss and accuracy, as would be done 'v lictosing actions.
Roeponse to Washington's Comments on IMPEP SS&D Non common "offormance Indicator 5.
NRC's response to Washington's Comment i states that the NRC Headquarters SS&D Evaluation Program will not be evaluated against the IMPEP Indicators, in order to establish a valid IMPEP program, NRC must evaluate its program elements against the same criteria it applies to those of the States. If NRC finds this IMPEP indicator to be inappropriate for its SS&D program, then it should propose others against which both NRC and the States can be evaluated fairly, r
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e Ms. Rita Aldrich, Principal Radiophysicist Radiological Health Unit Divit.lon of Safety and Health New York State Department of Labor NYS Office Campus, Bldg.12, Room 457
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Albany, NY 12240
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Dear Ms. Aldrich:
This is in reference to your September 2,1997 letter with comm<#nts on the revision to Managerr.ent Directive 5.6 (MJ 5.0), " Integrated l Material Performance Evaluation Program." We appreciate receiving your comme'nts, however, as we stated in our All Agreement Letter, SP 97 053, we needed compients by August 27,1997 to meet a Commission assignco due date of August 29,,1997 to prepare MD 5.6 in final. We were not able to includo your comments in our analvsis and fina! MD 5.6.
However, several of the issues you raised concerning the non common performance indicator, Scaled Source and Device Evaluation Program, were also made by other Agreement States. Based on the comments received, revisions were made to this indicator. We will consider your comments during our next revision to MD n.6. If you have any questions, please contact me at/301415 3340 nr Kathleen Schneider at 301-415-2320.
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/ Sincerely, Ric,,,ard L. Bangart, Director Office of State Programs f
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Distribution:
DIR RF DCD (SP03)
SDroggitis PDR (YES X NO_)
Management Directive File DOCUMENT NAME: G:\\KXS\\ALDRICK.KNS T;,eceive a copy of this document,indscate in the boa:
'C' = Copy without attachmentlenclosure
'E' = Copy with ettachmentlenclosure
'N' = No copy OFFICE OSP G3 OSP:DD OSP:D NAME" KSchneider:nb PHLohaus RLBangart DATE 09/;ay /97 09/
/97 09/
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