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