United States Nuclear Regulatory Commission - Protecting People and the Environment

Clarification of Scope of Quality Assurance (QA) Programs for Transport Packages Pursuant to 10 CFR 50, Appendix B

HPPOS-060 PDR-9111210243

See IE Information Notice No. 84-50 entitled as above and dated June 21, 1984. Certain aspects of QA programs required by 10 CFR 71, Subpart H are distinctly packaging related. Utility QA programs must address all applicable elements for transport packages.

The purpose of IE-84-50 is to eliminate any confusion as to the applicability of the QA provisions of 10 CFR 50, Appendix B, to certain transport packages for which a QA program is required by the provisions of 10 CFR 71, Subpart H.

Pursuant to 10 CFR 71.12 (b), 71.14 (b), and 71.16 (c) (2), licensees who transport certain transport packages or deliver them to a carrier for transport are required to have an NRC-approved QA program. Such a program must have been approved as satisfying the applicable provisions of 10 CFR 71, Subpart H [formerly Appendix E].

An applicant's request for such a program approval must be in accordance with 10 CFR 71.101 (c). Also, pursuant to 10 CFR 71.101 (b) [formerly 10 CFR 71.51], each licensee must establish, maintain, and execute a QA program that satisfies each of the applicable criteria of Subpart H. Under the provisions of 10 CFR 71.101 (f), however, a licensee may utilize a QA program which has been approved pursuant to 10 CFR 50,

Appendix B, "provided that the QA program is established, maintained, and executed with regard to transport packages." Therefore, an Appendix B program is acceptable in lieu of one approved specifically under Subpart H.

Past inspections of transport activities and associated QA programs of nuclear utilities have sometimes revealed a generic inadequacy regarding implementation by licensees of NRC-approved, 10 CFR 50, Appendix B, QA programs for "transport packages." Specifically, this inadequacy usually is evidenced by nonexistent or deficiently written QA audits for "transport packages." Apparently, some licensees have erroneously concluded that the previous NRC approval of the 10 CFR 50, Appendix B, program implies fulfillment of the implementing QA requirements for transport packages, without reservation.

Several of the criteria of 10 CFR 50, Appendix B, or 10 CFR 71, Subpart H, are programmatic (e.g., control of measuring and test equipment; document control). For these criteria, the associated implementing procedures may sometimes be common for both transport packing and non-transport activities. Certain other aspects, however, are distinctly packaging related (e.g., procedures controlling procurement of packaging; preparation of packaging for use, loading, and unloading the packaging; maintenance of the packaging, QA records, audits, checklists).

Consequently, the utility QA program must include and address all of the applicable elements for transport packages to meet the intent of 10 CFR 71.101 (f). Licensees should "not" automatically assume that such implementing procedures developed for Appendix B are adequate for transport packages unless such procedures do, in fact, address transport packages.

Regulatory references: 10 CFR 50, 10 CFR 71.101

Subject codes: 12.15, 12.17

Applicability: Reactors

Page Last Reviewed/Updated Monday, June 08, 2015