ML20151V145
| ML20151V145 | |
| Person / Time | |
|---|---|
| Site: | Fermi  |
| Issue date: | 09/08/1998 |
| From: | Kugler A NRC (Affiliation Not Assigned) |
| To: | Gipson D DETROIT EDISON CO. |
| References | |
| TAC-MA0750, TAC-MA750, NUDOCS 9809140111 | |
| Download: ML20151V145 (2) | |
Text
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Mr. Douglas R. Gipson September 8,1998 S:nior Vica Prssid:nt Nucl:ar G:n: ration Detroit Edison Company 6400 North Dixie Highway Newport, MI 48166
SUBJECT:
FERMI 2 - REVIEW OF QUALITY ASSURANCE DESCRIPTION SUBMITTAL IN ACCORDANCE WITH 10 CFR 50.54(a) REQUIREMENTS (TAC NO. MA0750)
Dear Mr. Gipson:
On January 14,1998, you submitted a proposed change that reduces commitments in your quality assurance program description as previously approved by the NRC. You requested NRC review and approval of the changes in accordance with 10 CFR 50.54(a). The proposed change would remove the fitness-for-duty (FFD) laboratory from the list of Nuclear Generation areas that will be audited on a periodic basis. The staff has completed its review and has determined that the proposed change is not appropriate and is, therefore, denied.
The requirements and standards for FFD programs for NRC licensees are established in 10 CFR Part 26. In particular,10 CFR 26.80 requires licensees to conduct annual audits of thc se portions of FFD programs implemented by contractors and vendors. This requirement app'ies to the use of laboratories certified by the Department of Health and Human Services (HHS) and any other contracted program support (e.g., collection, medical review officer services, and on-site testing). However, the staff recognizes that the current wording in 10 CFR 26.80 could be subject to interpretation with respect to this issue. Therefore, the NRC has initiated a rulemaking (61 FR 21105, May 9,1996) to revise, inter alia,10 CFR 26.80 to explicitly state that licensees must conduct annual audits of HHS-certified laboratories that are used for FFD programs.
Based on the requirements in 10 CFR 26.8s he FFD laboratory should not be removed from the list of Nuclear Generation areas that will be audited on a periodic basis. Therefore, the staff denies the proposed change.
If you have any questions concerning this issue, please contact me at (301) 415-2828.
Sincerely,
[
0 ORIGINAL SIGNED BY:
Q Andrew J. Kugler, Project Manager h UI Project Directorate 111-1 l
Division of Reactor Projects - lil/IV i
Office of Nuclear Reactor Regulation Docket No. 50-341 cc: See next page m
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DISTRIBUTION: See attached page n T;.
DOCUMENT NAME: G:\\WPDOCS\\ FERMI \\FE-A0750.LTR
- See previous concurrence Ta receive a copy of this document, Indicate in the box: "C"
- Copy without attachment /enclosurn "E" = Copy with attachment / enclosure 'N" = No copy OFFICE PM:PD31 l E LA:PD31 iE C:PSGB* l E C:HQMB* l E OGC*
l D:PD31 lE NAME AKugler: %
CJamerson c/
RRosano SBlack CMarco CACarpente( ( L I
DATE 09/ 8 /d8 09/ 6 /98 0
08/18/98 08/19/98 08/26/98 09/ 8 /98 11me,n OFFICIAL RECORD COPY 9809140111 980908 i
PDR ADOCK 05000341 P
PDR o
.: g,4 DATED:
DISTRIBUTION FOR LETTER ON QUALITY ASSURANCE REVIEW-FERMI 2 Docket File (50-341)
PUBLIC PD3-1 Rdg E. Adensam (EGA1)
A. Kugler C. Jamerson L. Bush M. Bugg OGC ACRS B. Burgess, Rlli 5
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