ML17362A362

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Letter to J. G. Head Quality Assurance Program Approval Form for Proposed Amendment to Draft NEDO-11209 Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description
ML17362A362
Person / Time
Site: 07100254
Issue date: 12/28/2017
From: Patricia Silva
NRC/NMSS/DSFM/IOB
To: Head J
GE-Hitachi Nuclear Energy Americas
Love E
References
NEDO-11209, Rev 13
Download: ML17362A362 (4)


Text

Mr. Jerald G. Head UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 28, 2017 Senior Vice President, Regulatory Affairs GE-Hitachi Nuclear Energy Americas, LLC P.O. Box 780, M/C A-18 Wilmington, NC 28401-0780

SUBJECT:

QUALITY ASSURANCE PROGRAM APPROVAL FORM FOR PROPOSED AMENDMENT TO DRAFT NED0-11209 REVISION 13, "GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION"

Dear Mr. Head:

Enclosed is the Quality Assurance (QA) Program Approval for the U.S. Nuclear Regulatory Commission (NRC) Radioactive Material Packages No. 0254, Revision 12, corresponding to the Draft NED0-11209 Revision 13, "GE Hitachi Nuclear Energy Quality Assurance Program Description", in response to your letter dated October 6, 2017 (Agencywide Documents Access and Management System Accession No. ML17279A629). This Approval satisfies the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 71.17(b) and 71.101 (c) for a QA Program approved by the NRC, as well as, approval of those changes to your QA Program that are considered reductions in commitments to the NRC, prior to implementation as required by 1 O CFR 71.106.

In addition, 10 CFR 71.106 requires that changes to your QA program that do not reduce commitments must be submitted to the NRC every 24-months, with the reporting period starting on the date your revised Form 311 was approved. Please note that if you did not make any changes to your QA program in the preceding 24-month period, you are required to report that no changes were made. Termination of your materials license does not cause this Approval to be automatically terminated. If you wish to renew, amend, or terminate this Approval, please request it in writing.

This letter also serves as a reminder that if you are using or planning to use an NRC-approved packaging, you must be registered for use of that packaging with NRC. Registration for use of NRC-approved packagings should be made pursuant to 1 O CFR 71.17(c)(3).

J. Head 2

If you have any questions, please contact me at 301-415-7399 or Earl Love at 301-415-7011.

Docket No. 71-0254 Sincerely,

!/J YlJi}--V #-CPj-frr Patricia Silva, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards

Enclosure:

QA Program Approval No. 71-0254, Rev. No. 12

NRC FORM 311 (08-2015)

U.S. NUCLEAR REGULATORY COMMISSION

1. APPROVAL NUMBER 071-0254 QUALITY ASSURANCE PROGRAM APPROVAL FOR RADIOACTIVE MATERIAL PACKAGES REVISION NUMBER 12 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Title 10, Code of Federal Regulations, Chapter 1, Part 71, and in reliance on statements and representations heretofore made in Item 4 by the organization named in Item 2, the Quality Assurance Program identified in Item 4 is hereby approved. This approval is issued to satisfy the requirements of Section 71.101 of 10 CFR Part 71. This approval is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
2. NAME GE Hitachi Nuclear Energy LLC (GEH)

STREET ADDRESS 3901 Castle Hayne Road, P.O. Box 780 CITY Wilmington

4. QUALITY ASSURANCE PROGRAM APPLICATION DATE(S)

STATE ZIP CODE NC 28402 NED0-11209-A, Revision 14 (Revision 13 draft submitted for review 10/06/2017)

5. CONDITIONS
3. DOCKET NUMBER 07100254
1. Activities conducted under applicable criteria of Appendix B to 10 CFR Part 50 are to be executed with regard to transportation packagings. Authorized activities include: design, procurement, fabrication, assembly, testing, modification, maintenance, repair, and use of transportation packagings. It shall remain the responsibility of the Quality Assurance Program holder that all transportation activities meet the requirements of 10 CFR 71.101.
2. Records shall be maintained in accordance with the provisions of 10 CFR Part 71. Specifically:
a. Records of each shipment of licensed material shall be maintained for 3 years after that shipment

[10 CFR 71.91 (a)].

b. Records providing evidence of packaging quality shall be maintained for 3 years after the life of the packaging [10 CFR 71.91 (d)].
c. Records describing activities affecting packaging quality shall be maintained for 3 years after this Quality Assurance Program Approval is terminated [10 CFR 71.135).
3. Planned and periodic audits of all aspects of the Quality Assurance Program shall be conducted in accordance with written procedures or checklists, by appropriately trained personnel not having direct responsibility in the areas being audited, in accordance with 10 CFR 71.137.
4. The QAPD implements GE Hitachi Nuclear Energy Quality Management System and is also applicable at the same location to:

Global Nuclear Fuel Americas, LLC FOR THE U.S. NUCLEAR REGULATORY COMMISSION Patricia Silva, Chief INSPECTIONS AND OPERATIONS BRANCH DIVISION OF SPENT FUEL MANAGEMENT OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS NRC FORM 311 (08-2015)

ML17362A362 OFC:

DSFM I E DSFM I E DSFM I NAME:

ELove SFigueroa CRoque-Cruz for PSilva DATE:

12/15/2017 12/28/17 12/28/17