ML20136H794

Submits Comments on 961218 Ortciger Ltr to Ph Lohaus Re Foreign Stds

ML20136H794
Person / Time
Issue date:	01/13/1997
From:	Bolling L NRC OFFICE OF STATE PROGRAMS (OSP)
To:	ILLINOIS, STATE OF
References
NUDOCS 9703190314
Download: ML20136H794 (3)

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Comments on 12/18/96 Ortciger letter to P.H. Lohaus re: Foreign Standards 1.

The U.S. Department of Transportation (DOT), not the NRC, is the competent authority in the U.S. for special form testing. Any questions in this area should be directed to the DOT.

2.

NRC will accept certain individual foreign standards, certificates or test results, including certain International Standards Organization (IS0) documents, to the extent that they meet the equivalent American National Standards Organization (ANSI) dccuments for the intended use of a specific source or device. At this time, however, we are not extending reciprocity to foreign standards or certificates "without question".

The points raised in the 12/18/96 letter from Mr. Ortciger were covered in two previous letters to the Illinois Department of Nuclear Safety (IDNS), the recently released Final Standard Review Plan for Sealed Source and Device 4

Evaluations (Nureg-1550) and Regulatory Guide 6.9 on Vendor Quality Assurance Programs. These two guidance documents were provided to All Agreement States.

I Based on the foregoing, and my conversation with Steve Baggett, NMSS, I do no see a need to respond in writing to Mr. Ortciger at this time.

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TASK DESCRIPTION - 12/18/96 RESPONSE TO OSP 9/11/96 LTR REGARDING RECC -

NITION OF INTERNATIONAL STANDARDS FOR SS&D EVt.LUATIONS REQUESTING OFF. - IL REQUESTER - T. ORTCIGER WITS -

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ACCESSION NBR 9612240119 DOC.DATE: 96/12/18 NOTARIZED: NO DOCKET #

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Illinois, State of RECIP.NAME RECIPIENT AFFILIATION LOHAUS,P.H.

Office of State Programs (Post 911117)

SUBJECT:

Ack receipt of 960911 ltr re recognition of international standards for sealed source & device evaluations.

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December 18,1996 1

Paul H. Lohaus Deputy Director Office of State Programs l

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Washington, DC 20555

Dear Mr. Lohaus:

Thank you for your letter of September 11,1996 regarding the recognition of international standards for sealed source and device (SS&D) evaluations. We l

appreciate the information as it clarified several issues that we have encountered in our sealed source and device reviews regarding ISO Standards and Regulatory Guide j

6.9. However, a few peints of clarification are necessary.

Regarding special form testing in Item 1, our question was not whether special i

form testing could replace ANSI testing but rather could this document be accepted as a stand alone document for special form testing. The internatio i

i to compare fairly well with the requirements of 49 CFR 173.469 i

In Item 2 of your letter, you appear to have contradicted a previous precedent set by NRC. At one point, I believe France was advised by NRC to accept a source evaluation performed by California Should this policy be reciprocal and extended to evaluations performed by our European counterparts as well?

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Certainly, once certain foreign authorities are considered to be competent by NRC or en Agreement State, we should recognize their standards / certificates. We are i

apparently prepared to do this for Certain ISO standards. Illinois would be very interested to know if your staff has seen any other documents from foreign entities ; g i

that may be considered acceptable.

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Paul H. Lohaus 4

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December 18,1996 i

l In Item 3, we interpreted the leak test document from the Physical Technical Federal Institution, Berlin, to be a document establishing leak test frequencies for

' hffyI sources based on the prototype testing rather than a leak test record as you suggest.

V The document appears to indicate that no further leak testing is required after the 4

initial leak test if the source is to be contained in a device that protects it from environmental hazards. Certainly, no information regarding the details of testing was j

included as you noted. This was included in a separate document in the submittal.

The information submitted in Items 4 and 5 of your letter is reassuring in that I

it suggests other standards can be substituted for currently recognized standards if justified, particularly in regard to quality assurance. We have been making an extensive effort to ensure that our licensees' programs meet Regulatory Guide 6.9 even to the point of requiring licensees to re-submit their QA plans in their entirety to

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include these additional components. Your statements indicate that only minor J

modifications may be necessary if they are currently operating within an ISO 9000 /y I

framework.

The Department is comparing each submittal to recognized standards and i

guidance documents (i.e., Reg. Guide 10.10, ANSI N542, Reg. Guide 6.9, etc.) as suggested. However, since many of our distributors are based in Europe, one would l

hope in the future that we could establish an agreement with competent foreign 3/

authorities recognizing these reviews in their entirety much as we do with the

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3 Agreement States and NRC. Obviously, much work remains toward that end, but it '

seems that we are already moving in that direction with the acceptance of many of the i

i ISO standards.

The Department appreciates your comments on these issues. They will certainly facilitate future SS&D reviews. If we may be of any further assistance, please contact our Division of Radioaptive Materials at (217) 785-9947.

1 Sincerely, M

Thomas W. Ortciger Director TWO:ren

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