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
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- See previous concurrence
OFC:
SFPO
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SFPO
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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
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 1 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information
Date of
Notice No.
Subject
Issuance
Issued to
_____________________________________________________________________________________
2002-34 Failure of Safety-Related
Circuit Breaker External
Auxiliary Switches at Columbia
Generating Station
11/25/2002
All holders of operating licenses
or construction permits for
nuclear power reactors.
2002-33
Notification of Permanent
Injunction Against Neutron
Products Incorporated of
Dickerson, Maryland
11/22/2002
All teletherapy and radiation
processing licensees.
2002-29 (Errata)
Recent Design Problems in
Safety Functions of Pneumatic
Systems
11/06/2002
All holders of operating licenses
or construction permits for
nuclear power reactors.
2002-32
Electromigration on
Semiconductor Integrated
Circuits
10/31/2002
All holders of operating licenses
for nuclear power reactors except
those who have ceased
operations and have certified that
fuel has been permanently
removed from the reactor vessel.
2002-31
Potentially Defective UF6
Cylinder Valves (1-inch)
10/31/2002
All licensees authorized to
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
Portable Gauges During Field
Operations
10/30/2002
All NRC licensees authorized to
possess, use, transport, and store
portable gauges.
2002-29
Recent Design Problems in
Safety Functions of Pneumatic
Systems
10/15/2002
All holders of operating licenses
or construction permits for
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
Injunction Against Neutron
Products Incorporated of
Dickerson, Maryland
11/22/2002
All teletherapy and radiation
processing licensees.
2002-31
Potentially Defective UF6
Cylinder Valves (1-inch)
10/31/2002
All licensees authorized to
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
Portable Gauges During Field
Operations
10/30/2002
All NRC licensees authorized to
possess, use, transport, and store
portable gauges.
2002-28
Appointment of Radiation
Safety Officers and Authorized
Users Under 10 CFR Part 35
09/27/2002 All medical licensees.
2002-23
Unauthorized Administration of
Byproduct Material for Medical
Use
07/16/2002 All medical licensees.
2002-19
Medical Misadministrations
Caused By Failure to Properly
Perform Tests on Dose
Calibrators for Beta- and Low- Energy Photon-Emitting
Radionuclides
06/14/2002
All nuclear pharmacies and
medical licensees.
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