ML23013A227
| ML23013A227 | |
| Person / Time | |
|---|---|
| Site: | 07103056, 07103102 |
| Issue date: | 12/14/2022 |
| From: | Diane Jackson STERIS Applied Sterilization Technologies |
| To: | Boyle R Office of Nuclear Material Safety and Safeguards, US Dept of Transportation, Pipeline & Hazardous Materials Safety Admin |
| References | |
| Download: ML23013A227 (1) | |
Text
STERIS December 14, 2022 Mr. Rick Boyle - Chief, Radioactive Materials USDOT, PHMSA 1200 New Jersey Avenue, SE Washington, D.C. 20590-0001 RIck boyle@dot go Re: Docket No. 71-3102 Request for Revalidation of United Kingdom Certificate of Approval (GB/4120/B(U) for the DPR 200 Package Mr. Boyle, Isomedix Operations, Inc. and STERIS Isomedix Puerto Rico, LLC, wOuld like to respond to the U.S.
Nuclear Regulatory Commission (NRC) Request for Supplementary Information which was forwarded to our attention on 12/8/2022.
RAI 4-1 Clarify the leakage criteria for the DPR 200 package and whether the DPR 200 package is considered "leakight under the American National Standards Institute (ANSI) N14.5 or International Organization for Standardization (1sO) 12807 definition of the tem. For non-spent fuel contents, describe how the package user demonstrates that the package meets the criteria for IAEA sSR-6, Paragraph 671(a).
Section 6.7 of report SR-030: DPR 200 Containment Safety Assessment is entitled:
"Leaktightness". In this section the applicant states:
The containment system must be capable of retaining solid radioactive material which, in the worst case, could mean a fine powder. Paralgraph] 659.13, SSG-26, quotes a helium leak rate of 105 Pa-M/s as being sufficient to retain "even the smallest particle size powder'. This is therefore the criteria used in testing the containment bounday and the seals.
The staff notes that the helium leak cited above is greater than the "leaktight criteria defined in ANSI N14.5-2014 (or the corresponding ISO 12807 standard) which defines "leaktighe' as demonstration of a leakage rate less than or equal to 1E10- ref-cm/s, which is equal to 1E10 8 Pa-m/s. If the package is not "leaktight" a demonstration that the package meets the radioactive release limits in SSR-6 Paragraph 671(a) will need to be provided.
This information is needed to determine compliance with SSR-6 Paragraphs 659 and 671(a)
RESPONSE
We acknowledge the difference between the requirements for "leaktightness" in the standards and request that the requirement for operators to use 1 x 10E-8 Pa-M3/s as the helium leak rate criteria for non-special form contents be added to the validation.
Please let me know what else I can do to assist in the review process. Any additional information that is needed by either you or US NRC will be provided in a timely manner.
Thank you for your help in this process and please contact me at the information below with any requests.
David M. Jackson, CIH Sr. Manager, Radiation Safety/ Corporate RSO STERIS Applied Sterilization Technologies 3951 Dayton Road Madison. OH 44057 440 413 8681 Cc Mark Thomas Jennifer Pearce