ML023520339

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555

December 20, 2002

NRC INFORMATION NOTICE 2002-35: CHANGES TO 10 CFR PARTS 71 AND 72

QUALITY ASSURANCE PROGRAMS

Addressees:

All holders of 10 CFR Part 71 quality assurance (QA) program approvals and all 10 CFR Part

72 licensees and certificate holders.

Purpose:

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to remind

addressees of the requirement to obtain NRC approval of all changes to Parts 71 and 72 QA

programs before implementation of the changes. It is expected that recipients will review the

information for applicability to their facilities and consider actions, as appropriate, to avoid

similar problems. However, suggestions contained in this information notice are not new NRC

requirements; therefore, no specific action nor written response is required.

Description of Circumstances:

There have been several recent instances in which holders of Parts 71 and 72 QA program

approvals have implemented changes to their NRC-approved QA programs before obtaining

NRC approval. Although many QA program changes have been found acceptable to NRC,

after review, some changes have not satisfied the respective requirements of Part 71,

Subpart H, or Part 72, Subpart G. In one instance, enforcement action was taken and the QA

program approval holder had to expend considerable effort to complete corrective actions and

reestablish compliance with requirements.

Discussion:

The regulations of Part 71 require that licensees and applicants for Certificates of Compliance

(CoCs) have QA programs approved by the Commission as satisfying the provisions of

Subpart H of Part 71. Similarly, the regulations of Part 72 require that licensees, certificate

holders, and applicants for licenses or CoCs have approved QA programs satisfying the criteria

of Subpart G of Part 72.

Unlike 10 CFR Part 50, there are no specific requirements, in Parts 71 and 72, addressing

changes to an NRC-approved QA program. Once a Part 71 or 72 QA program is approved, no

changes to the program may be made without further NRC approval, because a change would 

alter the program and make it an unapproved program. Thus, the regulations require that any

proposed change to an NRC-approved Part 71 or 72 QA program, regardless of substance or

effect on commitments, must be approved by NRC before implementation. All holders of QA
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program approvals are reminded of, and expected to comply with, these requirements. NRC

will consider enforcement actions when and as appropriate, consistent with the NRC

Enforcement Policy.

The Parts 71 and 72 requirements for prior approval for all QA program changes do not apply

to Part 50 licensees that apply their approved Part 50, Appendix B, QA programs as provided in

10 CFR 71.101(f) or 10 CFR 72.140(d). These licensees may continue to make changes to

their QA programs, under 10 CFR 50.54. The requirements do apply to Part 50 licensees that

apply separate Part 71 or 72 QA programs to Part 71 or 72 activities.

In the interests of reducing regulatory burden and increasing efficiency, NRC is considering

changes to Parts 71 and 72, to provide a method similar to the provisions of

10 CFR 50.54(a)(3) and (4) for making changes to QA programs. However, until regulatory

changes are developed and promulgated, Parts 71 and 72 QA program approval holders must

comply with the current requirements.

This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, please contact the technical contact listed below

or the appropriate regional office.

/RA/

E. William Brach, Director

Spent Fuel Project Office 

Office of Nuclear Material Safety

 and Safeguards

Technical Contact: Frank Jacobs, NMSS 

(301) 415-3961

E-mail: fxj2@nrc.gov

Attachments:

1. List of Recently Issued NRC Information Notices

2. List of Recently Issued NMSS Information Notices