Information Notice 2002-35, Changes to 10 CFR Parts 71 and 72 Quality Assurance Programs
| ML023520339 | |
| Person / Time | |
|---|---|
| Issue date: | 12/20/2002 |
| From: | Brach E NRC/NMSS/SFPO |
| To: | |
| Jacobs F NMSS/SFPO (301) 415-3961 | |
| References | |
| 10 CFR Part 71, 10 CFR Part 72 IN-02-035 | |
| Download: ML023520339 (6) | |
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
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
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 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
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
C:\ORPCheckout\FileNET\ML023520339.wpd *See previous concurrence
OFC: SFPO C SFPO C OGC NMSS SFPO
NAME: FJacobs* MTokar* STreby* EKraus* EWBrach*
DATE: 10/8/02 10/8/02 11/19/02 11/19/02 12/6/02 OFFICIAL RECORD COPY
Attachment 1 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2002-34 Failure of Safety-Related 11/25/2002 All holders of operating licenses
Circuit Breaker External or construction permits for
Auxiliary Switches at Columbia nuclear power reactors.
Generating Station
2002-33 Notification of Permanent 11/22/2002 All teletherapy and radiation
Injunction Against Neutron processing licensees.
Products Incorporated of
Dickerson, Maryland
2002-29 Recent Design Problems in 11/06/2002 All holders of operating licenses
(Errata) Safety Functions of Pneumatic or construction permits for
Systems nuclear power reactors.
2002-32 Electromigration on 10/31/2002 All holders of operating licenses
Semiconductor Integrated for nuclear power reactors except
Circuits those who have ceased
operations and have certified that
fuel has been permanently
removed from the reactor vessel.
2002-31 Potentially Defective UF6 10/31/2002 All licensees authorized to
Cylinder Valves (1-inch) possess and use source material
and/or special nuclear material for
the heating, emptying, filling, or
shipping of uranium hexafluoride
(UF6) in 30- and 48-inch
cylinders.
2002-30 Control and Surveillance of 10/30/2002 All NRC licensees authorized to
Portable Gauges During Field possess, use, transport, and store
Operations portable gauges.
2002-29 Recent Design Problems in 10/15/2002 All holders of operating licenses
Safety Functions of Pneumatic or construction permits for
Systems nuclear power reactors.
Note: NRC generic communications may be received in electronic format shortly after they are
issued by subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following
command in the message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 2 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2002-33 Notification of Permanent 11/22/2002 All teletherapy and radiation
Injunction Against Neutron processing licensees.
Products Incorporated of
Dickerson, Maryland
2002-31 Potentially Defective UF6 10/31/2002 All licensees authorized to
Cylinder Valves (1-inch) possess and use source material
and/or special nuclear material for
the heating, emptying, filling, or
shipping of uranium hexafluoride
(UF6) in 30- and 48-inch
cylinders.
2002-30 Control and Surveillance of 10/30/2002 All NRC licensees authorized to
Portable Gauges During Field possess, use, transport, and store
Operations portable gauges.
2002-28 Appointment of Radiation 09/27/2002 All medical licensees.
Safety Officers and Authorized
Users Under 10 CFR Part 35
2002-23 Unauthorized Administration of 07/16/2002 All medical licensees.
Byproduct Material for Medical
Use
2002-19 Medical Misadministrations 06/14/2002 All nuclear pharmacies and
Caused By Failure to Properly medical licensees.
Perform Tests on Dose
Calibrators for Beta- and Low- Energy Photon-Emitting
Radionuclides
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit