ML21228A040
| ML21228A040 | |
| Person / Time | |
|---|---|
| Site: | 99902080 |
| Issue date: | 09/07/2021 |
| From: | Michael Balazik NRC/NRR/DANU/UNPL |
| To: | Eiden T Atomic Alchemy |
| Balazik M | |
| References | |
| EPID L-2020-LLL-0025 | |
| Download: ML21228A040 (8) | |
Text
Mr. Thomas Eiden Chief Executive Office Atomic Alchemy Inc.
855 North Capital Ave, STE #3 Idaho Falls, ID 83402-3405
SUBJECT:
ATOMIC ALCHEMY INC. - REQUEST FOR ADDITIONAL INFORMATION SECOND ROUND RE: VERSATILE ISOTOPE PRODUCTION REACTOR QUALITY ASSURANCE PROGRAM DESCRIPTION TOPICAL REPORT (EPID L-2020-LLL-0025)
Dear Mr. Eiden:
By letter dated October 16, 2020 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20290A978), and enclosures (ADAMS Accession Nos. ML20290A979 and ML20290A980), Atomic Alchemy Inc. (Atomic Alchemy) submitted a quality assurance program description (QAPD) as a topical report (TR) for the Atomic Alchemy Versatile Isotope Production Reactor for review and approval by the U.S. Nuclear Regulatory Commission (NRC) staff. The NRC staff issued a request for additional information (RAI) by letter dated April 23, 2021 (ADAMS Accession No. ML21091A114), and Atomic Alchemy submitted information in response to the NRC staffs request by letter dated June 22, 2021 (ADAMS Accession Package No. ML21173A000).
The NRC staff identified additional information needed to continue its review of the QAPD TR, as described in the enclosed RAI. As discussed by telephone on August 30, 2021, provide a response to the RAI or a written request for additional time to respond, including the proposed response date and a brief explanation of the reason, within 30 days of the date of this letter. Following receipt of the complete response to the RAI, the NRC staff will continue its review of the QAPD TR.
The response to the RAI must be submitted in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 50.4, Written communications. Information included in the response that you consider sensitive or proprietary, and seek to have withheld from public disclosure, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding.
Based on the response date provided above, the NRC staff expects to complete its review of the QAPD TR by December 10, 2021. This date could change due to several factors including a need for further RAIs, unanticipated changes to the scope of the review, unsolicited supplements to the TR, and others.
August 31, 2021
T. Eiden 2
If the forecasted date changes, the NRC staff will notify you in writing of the new date and an explanation of the reason for the change. In the case that the NRC staff requires additional information beyond that provided in the response to this RAI, the NRC staff will request that information by separate correspondence.
If you have any questions regarding the NRC staffs review or if you intend to request additional time to respond, please contact me at (301) 415-2856, or by electronic mail at Michael.Balazik@nrc.gov.
Sincerely Michael F. Balazik, Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Project No. 99902080
Enclosure:
As stated cc: See next page Signed by Balazik, Michael on 08/31/21
Atomic Alchemy Inc.
Project No. 99902080 cc:
Michael Grochowski Regulatory Affairs & Compliance Licensing Manager Atomic Alchemy Inc.
855 North Capital Ave, STE #3 Idaho Falls, ID 83402-3405 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115
ML21228A040 NRR-088 OFFICE NRR/DANU/UNPL/PM NRR/DRO/IQVB NRR/DANU/UNPL/LA NRR/DANU/UNPL/BC NAME MBalazik AKeim NParker JBorromeo DATE 8/19/2021 8/19/2021 8/19/2021 8/26/2021 OFFICE NRR/DANU/DD NRR/DANU/UNPL/PM NAME BSmith MBalazik DATE 8/26/2021 8/31/2021
Enclosure OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING THE QUALITY ASSURANCE PROGRAM DESCRIPTION ATOMIC ALCHEMY INC.
PROJECT NO. 99902080 By letter dated October 16, 2020 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20290A978), and enclosures (ADAMS Accession Nos. ML20290A979 and ML20290A980), Atomic Alchemy Inc. (Atomic Alchemy) submitted for U.S. Nuclear Regulatory Commission (NRC) staff review AA0-VIPR-20-QAPD(NP), Atomic Alchemy Inc. Topical Report: Quality Assurance Program Description, Revision 0 and supplemented by letter dated June 22, 2021 (ADAMS Accession Package No. ML21173A000).
Atomic Alchemy requested NRC staff approval of the topical report (TR) to be used to satisfy quality assurance requirements for use in its applications submitted in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, related to facility design, procurement, construction, and operation.
The NRC staff reviewed the quality assurance program description (QAPD) TR and supplemental information for compliance with regulations using the following guidance and standard(s):
o NUREG-1537 Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ADAMS Accession No. ML042430055) o NUREG-1537 Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (ADAMS Accession No. ML042430048) o Regulatory Guide 2.5, Revision 1, Quality Assurance Program Requirements for Research and Test Reactors (ADAMS Accession No. ML093520099) o Regulatory Guide 1.28, Revision 5, Quality Assurance Program Criteria (Design and Construction) (ADAMS Accession No. ML17207A293) o American National Standard Institute/American Nuclear Society (ANSI/ANS)-15.8-1995, Quality Assurance Program Requirements for Research Reactors The NRC staff has completed a review of Atomic Alchemys request for additional information response, dated June 22, 2021 (ADAMS Accession Package No. ML21173A00), and determined additional information is required to complete its review.
2 1.
In ASME-NQA-1-2017, Quality Assurance Requirements for Nuclear Facility Applications, Part II, Subpart 2.19, is based on International Organization for Standards (ISO) 17025-2005 for the acceptance of supplier accreditation for calibration or testing services. ISO has recently withdrawn ISO 17025-2005 and therefore, ASME-NQA-1-2017, Part II, Subpart 2.19 endorses a standard that is no longer valid. Nuclear Energy Institute (NEI)14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, dated September 11, 2020 (ADAMS Accession No. ML20259B731) addressees this issue with ISO 17025-2005. The NRC staff evaluated NEI 14-05A, Revision 1, and documented the results in a safety evaluation (SE) report, dated November 23, 2020 (ADAMS Accession No. ML20322A019). Atomic Alchemys QAPD uses the guidance in ASME-NQA 2017, Part II, Subpart 2.19 that currently refers to ISO 17025-2005 and does not reflect the latest guidelines in NEI 14-05A, Revision 1, or the related NRC staffs SE.
Because Atomic Alchemys QAPD uses guidance in ASME-NQA-1-2017, Part II, Subpart 2.19, provide an updated QAPD TR to reflect the use of the current approved alternative, as described in NEI 14-05A, Revision 1, and the NRC staffs SE, or the performance of commercial grade surveys for procurement of laboratory calibration and testing services.