United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

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

HPPOS-060 PDR-9111210243

Title: Clarification of Scope of Quality Assurance (QA)

Programs for Transport Packages Pursuant to 10 CFR 50,

Appendix B

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 Thursday, March 29, 2012