The following report was received via fax:
ASCO reviewed a Part 21 notification, received from Steris Isomedix Services, to see if the reported non conformance would impact qualification levels. Based on this review, ASCO determined that even if the radiation levels, applied to components, were lower than reported on the original certifications, the additional radiation dose added to meet the 10% margin suggested by IEEE 323 would envelope this variation. Therefore, the qualification levels listed in ASCO qualification reports would not be impacted. Based on this review, ASCO determined that it was not necessary to implement 10 CFR part 21 notifications since the reported qualification levels remain unchanged.
If you have any questions, you can contact Michael Adase at Michael.adase@emerson.com or 803-641-9345.
Note: The NRC has received reports from four (4) other Steris Isomedix customers concerning this issue; EN#50253, #50285, #50359, and #50434.
- * * UPDATE AT 1507 EDT ON 8/19/2015 * * *
The following, in part, was received from Asco Valve, Inc. via fax:
On December 15, 2014, ASCO Valve Inc. (ASCO) issued an interim report to the USNRC. The interim report was issued because ASCO was awaiting additional information from Steris and was not able to complete their evaluation of Ref B within the 60 day time limit. A December 19, 2014 update from Steris contained no additional substantive information. Although further information from Steris was not received, ASCO has since received the 'Industry Guidance Position Paper Responding to the 2014 Steris 10 CFPR Part 21', from the NUGEQ [Nuclear Utility Group on Equipment Qualification].
ASCO has completed the review and calculated the minimum radiation exposure applied during qualification of ASCO nuclear qualified products at Steris. Based on this review, ASCO has determined that the minimum dose is less than what was originally reported in the ASCO qualification reports. ASCO is in the process of updating our reports and revising our certifications.
Since ASCO is not able to determine what, if any impact these reduced radiation dose levels will have on the qualification testing of safety related equipment, we are forwarding this information to allow for a review of applicable qualification documentation and reports.
Notified R1DO (DeFrancisco), R2DO (Heisserer), R3DO (Riemer), R4DO (Hay), and Part 21 Group (email).