United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 95-58: 10 CFR 34.20; Final Effective Date

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C.  20555

                               December 18, 1995


NRC INFORMATION NOTICE 95-58:  10 CFR 34.20; FINAL EFFECTIVE DATE

Addressees:

Industrial Radiography Licensees

Purpose:

The U.S. Nuclear Regulatory Commission is issuing this information notice (IN)
to remind addressees of the effective date implementing a final provision of
the regulations in 10 CFR 34.20.  It is expected that recipients will review
the information for applicability to their facilities and consider appropriate
actions.  This notice also advises recipients of the Commission's plans for
enforcement action to address failures to meet 10 CFR 34.20.  However, this IN
does not contain any new requirements; therefore, no specific action or
written response is required.

Background:

Paragraph (e) of 10 CFR 34.20 provides that all radiographic exposure devices
and associated equipment in use by NRC licensees after January 10, 1996, must
comply with the requirements specified in Section 34.20 of 10 CFR Part 34. 
Section 34.20, and other changes to 10 CFR Part 34, were published in the
Federal Register (55 FR 843) as a final rule on January 10, 1990.  As stated
in the Federal Register notice, the effective date of the final rule was
January 10, 1991.  Paragraph (d) of 10 CFR 34.20 provided that all newly-
manufactured radiographic exposure devices and associated equipment
(manufactured after January 10, 1992) acquired by NRC licensees must meet
10 CFR 34.20 requirements.  The statement of considerations for the final rule
provided notice that failure to implement the requirements for equipment by
the required date may be considered a Severity Level III Violation.  Such
violations are considered for civil penalty assessments.

After publication of the final rule, NRC transmitted copies of the notice to
each of its radiography licensees at that time.  Copies of the notice were
also provided to each of the Agreement States so that they might share the
information with their radiography licensees.  Further information identifying
and explaining the effective dates of the various provisions of the rule was
also provided in the March-June 1990 (NUREG/BR-0117 Nos. 90-1 and -2) issues
of the NMSS Licensee Newsletter.


9512180076.                                                            IN 95-58
                                                            December 18, 1995
                                                            Page 2 of 4

Discussion:

The NRC reminds its industrial radiography licensees that after January 10,
1996, only radiographic exposure devices and associated equipment which
complies with the requirements specified in 10 CFR 34.20 and is authorized by
the license, shall be used in industrial radiography operations conducted
within NRC's jurisdiction.  NRC also reminds Agreement State licensees working
in areas of NRC jurisdiction under reciprocity (10 CFR 150.20) that they are
also subject to these requirements.  The regulations in 10 CFR 34.20 apply to
all radiography equipment.  This includes portable, mobile, and fixed
radiography cameras (both pipeliner and "crank-out" type devices), source
changers, and other associated equipment used with radiography cameras, i.e.,
source assemblies, drive cables, guide tubes, control tubes, source stops,
etc.  Some provisions of 10 CFR 34.20 only apply to certain types of
equipment.  For example, 10 CFR 34.20(c) only applies to "crank-out" cameras,
while 10 CFR 34.20(a) and (b) apply to all radiography cameras and all
associated equipment.  As another example, the criteria specified in 10 CFR
34.20(c)(9) only applies to the source changer used in conjunction with a
"crank-out" device.

The requirements in 10 CFR 34.20 require licensees to ensure that all
equipment they will use in radiographic operations after January 10, 1996,
complies with the applicable requirements.  Since publication of NRC's final
rule, the radiography equipment manufacturers have worked to develop
radiography devices and associated equipment that complies with 10 CFR 34.20
criteria.  In some instances, existing equipment already complies with the
regulatory requirements.  Attachment 1 lists the radiography cameras,
radiography systems, and sealed sources that have been recognized by NRC as
meeting 10 CFR 34.20 requirements.

Traditionally, certain associated equipment has not been independently
registered and/or evaluated by the NRC or the Agreement States.  This includes
drive cables, guide tubes, or source stops.  With the new camera models
introduced, the manufacturers and NRC have taken the system approach as
denoted in the American National Standard N432-1980, "Radiological Safety for
the Design and Construction of Apparatus for Gamma Radiography," now required
by regulations.  Therefore, information concerning the drive cables to be used
with the devices was included as part of the overall system evaluation. 
However, older "associated equipment" items may not have been evaluated as
part of a device registration process.  Licensees are reminded that 10 CFR
34.20 makes the licensee responsible for ensuring that the equipment meets
regulatory requirements.  The licensee should obtain information from the
equipment manufacturer which shows the equipment complies with 10 CFR 34.20
criteria, including any required testing.  Equipment that has not been
registered will, at minimum, require prototype testing to meet the
requirements of 10 CFR 34.20.  If a similar piece of equipment has already met
the test requirements, then an engineering analysis may be used in lieu of
actual testing.  The engineering analysis can be performed by the user or the
manufacturer and submitted to the appropriate regulatory authority for
evaluation and approval..                                                            IN 95-58
                                                            December 18, 1995
                                                            Page 3 of 4

Your present license may include equipment whose use must be discontinued
after January 10, 1996.  In this instance, the NRC regulations effective
January 10, 1996, take precedent over authorizations previously provided in a
license.  For example, if your license contains an Amersham Model 900, you are
not authorized to continue using this device after January 10, 1996.  Please
also note that you may need to amend your license to include additional
equipment that complies with 10 CFR 34.20.  

Exemptions will not normally be considered for portable radiographic devices
that do not comply with 10 CFR 34.20.  If uninterrupted use of a device which
does not comply with 10 CFR 34.20 is intended, then an exemption request
should be submitted prior to January 1, 1996, to allow the staff adequate time
to process the request.  Exemptions to 10 CFR 34.20 may be considered only for
limited special or unique cases, where the licensee can demonstrate that the
engineered safety features, use limitations, and procedures would compensate
for not meeting the requirements and afford similar or increased radiation
safety protection.  An example of a limited special or unique case would
include a nonportable device used in a fixed radiographic facility.

Performance of radiography after January 10, 1996, with equipment which does
not comply with the requirements of 10 CFR 34.20 is a violation of Commission
requirements.  In accordance with example C.8 of Supplement VI of the
Commission's Enforcement Policy, such violations are considered violations of
significant regulatory concern and may be categorized at Severity Level III
and subject to civil penalties.  In light of the notice that has been given
licensees to meet this regulation, the time that has been provided licensees
to achieve compliance, and the importance of meeting the requirements of
10 CFR 34.20, the NRC intends to levy a civil penalty without considering the
normal civil penalty assessment process pursuant to Section VII.A.1 of the
Enforcement Policy.  Accordingly, a civil penalty of $5,000, the base Severity
Level III civil penalty, may be assessed for each camera a licensee uses after
January 10, 1996, that does not meet the requirements of 10 CFR 34.20.  If
during an inspection, the NRC identifies that a licensee is not meeting the
regulation, the licensee will need to suspend any operation with nonconforming
cameras.  Failure to do so may be considered deliberate violations and may
subject the licensee to significant civil action, including license
revocation, and to criminal sanctions.  Individuals responsible for such
violations may be subject to sanctions for violating 10 CFR 30.10, rule on
"Deliberate Misconduct."

However, the Commission intends to exercise its enforcement discretion for
licensees who make a good faith effort to comply with 10 CFR 34.20 before the
effective date of the rule.  Therefore, a licensee who performs radiography
after January 10, 1996, with equipment that does not meet 10 CFR 34.20 will
not be subject to civil penalties or suspension of operations for such
violations if the licensee has evidence that on or before January 10, 1996, it
in good faith ordered equipment for prompt replacement that meets the
requirements of 10 CFR 34.20.  It should be noted that Agreement State
licensees conducting radiography under reciprocity will be subject to these
regulatory requirements and enforcement policy..                                                            IN 95-58
                                                            December 18, 1995
                                                            Page 4 of 4


This information notice requires no specific action or written response.  If
you have any questions about the information in this notice, please contact
one of the technical contacts listed below or the appropriate regional office.




                                      Donald A. Cool, Director
                                      Division of Industrial and 
                                        Medical Nuclear Safety
                                      Office of Nuclear Material 
                                        Safety and Safeguards


Contacts:  J. Bruce Carrico, NMSS (For general information)
           (301) 415-7826

           Thomas W. Rich, NMSS (For device information)
           (301) 415-7893

Attachments:  1.  List of Approved Equipment
              2.  List of Recently Issued NMSS Information Notices
              3.  List of Recently Issued NRC Information Notices
.                                                           Attachment 1
                                                           IN 95-58
                                                           December 18, 1995
                                                           Page 1 of 8

                                                                11/21/95

             List of Models That Meet 10 CFR Part 34 Requirements

                                   CAMERA(s)

Model           Manufacturer         Status       Description

  660 A         AMERSHAM             ACTIVE       Co-60 110mCi,
                                                  Cs-137 10.8Ci,
                                                  Yb-169 20Ci, Tm-170
                                                  200Ci, Ir-192 120Ci

  660 AE        AMERSHAM             ACTIVE       Co-60 110mCi,
                                                  Cs-137 10.8Ci,
                                                  Yb-169 20Ci, Tm-170
                                                  200Ci, Ir-169 120Ci

  660 B         AMERSHAM             ACTIVE       Co-60 110mCi,
                                                  Cs-137 10.8Ci,
                                                  Yb-169 20Ci, Tm-170
                                                  200Ci, Ir-192 140Ci

  660 BE        AMERSHAM             ACTIVE       Co-60 110mCi,
                                                  Cs-137 10.8Ci
                                                  Yb-169 20Ci, Tm-170
                                                  200Ci, Ir-192 140Ci

  660 SYSTEM    AMERSHAM             ACTIVE       Co-60 110mCi,
                                                  Cs-137 10.8Ci,
                                                  Yb-169 20Ci, Tm-170
                                                  200Ci, Ir-192 140Ci

  676 A         AMERSHAM             ACTIVE       Co-60 330Ci, DU 168
                                                  kg

  676 AE        AMERSHAM             ACTIVE       Co-60 330Ci, DU 168
                                                  kg

  676 B         AMERSHAM             ACTIVE       Co-60 330Ci, DU 168
                                                  kg


  676 BE        AMERSHAM             ACTIVE       Co-60 33OCi, DU 168
                                                  kg

  680 A         AMERSHAM             ACTIVE       Co-60 110ci, DU 129 kg

  680 AE        AMERSHAM             ACTIVE       Co-60 110Ci, DU 129 kg.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 2 of 8

                                                  11/21/95

             List of Models That Meet 10 CFR Part 34 Requirements


                             CAMERA(S) (continued)


Model           Manufacturer         Status       Description

  680 B         AMERSHAM             ACTIVE       Co-60 110ci, DU 129
                                                  kg

  680 BE        AMERSHAM             ACTIVE       Co-60 110ci, DU 129
                                                  kg

  684 A         AMERSHAM             ACTIVE       Co-60 110Ci, Ir-192
                                                  240Ci, DU 68 kg

  684 AE        AMERSHAM             ACTIVE       Co-60 11Ci, Ir-192
                                                  240Ci, DU 68 kg

  684 B         AMERSHAM             ACTIVE       Co-60 11ci, Ir-192
                                                  240Ci, DU 68 kg

  684 BE        AMERSHAM             ACTIVE       Co-60 11ci, Ir-192
                                                  240Ci, DU 68 kg

  741 A         AMERSHAM             ACTIVE       Co-60 33Ci, Ir-192
                                                  240Ci, DU 90 kg

  741 AE        AMERSHAM             ACTIVE       Co-60 33Ci, Ir-192
                                                  240Ci, DU 90 kg

  741 B         AMERSHAM             ACTIVE       Co-60 33Ci, Ir-192
                                                  240Ci, DU 90 kg

  741 BE        AMERSHAM             ACTIVE       Co-60 33Ci, Ir-192
                                                  240Ci, DU 90 kg

  865           AMERSHAM             ACTIVE       Ir-192 240Ci, DU 18
                                                  kg

  IR-100        INDUSTRIAL           ACTIVE       Ir-192 120Ci, DU NUCLEAR14.5
kg

  SPEC 150      SPEC                 ACTIVE       Ir-192 150Ci, DU 17 kg

  TITAN         NORDION              ACTIVE       Ir-192 140Ci.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 3 of 8

                                                  11/21/95

              List of Models That Meet 10 CFR Part 34 Requirements

                              SOURCE(S) (continued)


  Model       Manufacturer            Status      Description

  32          INDUSTRIAL NUCLEAR      ACTIVE      Ir-192 120Ci

  33          INDUSTRIAL NUCLEAR      ACTIVE      Ir-192 120Ci

  702         RTS                     ACTIVE      Ir-192 120Ci

  848         AMERSHAM                INACTIVE    Cs-137 30Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

  866         AMERSHAM                ACTIVE      Cs-137 30 Ci
                                                  Yb-169 200Ci,
                                                  Tm-170 50Ci, Ir-192
                                                  240Ci

  87702       AMERSHAM                INACTIVE    Ir-192 120Ci
  87703       AMERSHAM                ACTIVE      Ir-192 120Ci
  87704       AMERSHAM                INACTIVE    Ir-192 120Ci
  88          INDUSTRIAL NUCLEAR      ACTIVE      Ir-192 120Ci
  89911       AMERSHAM                ACTIVE      Ir-192 240Ci
  89912       AMERSHAM                ACTIVE      IR-192 240CI
  89913       AMERSHAM                ACTIVE      IR-192 240CI
  89914       AMERSHAM                ACTIVE      IR-192 240CI
  89916       AMERSHAM                ACTIVE      IR-192 240CI
  89921       AMERSHAM                ACTIVE      IR-192 240CI
  89922       AMERSHAM                ACTIVE      IR-192 240CI
  89923       AMERSHAM                ACTIVE      IR-192 240CI
  89924       AMERSHAM                ACTIVE      IR-192 240CI
  90003       AMERSHAM                ACTIVE      Ir-192 240Ci.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 4 of 8

                                                   11/21/95

              List of Models That Meet 10 CFR Part 34 Requirements


                              SOURCE(S) (continued)


Model         Manufacturer            Status      Description

91810         AMERSHAM                ACTIVE      Yb-169 20Ci
91811         AMERSHAM                ACTIVE      Co-60 20Ci
91812         AMERSHAM                ACTIVE      Tm-170 20Ci
91813         AMERSHAM                ACTIVE      Ir-192 20Ci
943           AMERSHAM                ACTIVE      Co-60 110Ci
A424-1        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50
                                                  Ci, Ir-192 240Ci

A424-10       AMERSHAM                ACTIVE      Co-60 5Ci
A424-11       AMERSHAM                ACTIVE      Co-60 50Ci
A424-12       AMERSHAM                ACTIVE      Co-60 100Ci
A424-13       AMERSHAM                ACTIVE      Co-60 330Ci
A424-14       AMERSHAM                ACTIVE      Co-60 110Ci
A424-15       AMERSHAM                ACTIVE      Co-60 11Ci
A424-16       AMERSHAM                ACTIVE      Co-60 50Ci
A424-17       AMERSHAM                ACTIVE      Co-60 50Ci
A424-18       AMERSHAM                ACTIVE      Co-60 33Ci
A424-19       AMERSHAM                ACTIVE      Co-60 120mCi
A424-2        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-20       AMERSHAM                ACTIVE      Cs-137 30Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 5 of 8

                                                   11/21/95

              List of Models That Meet 10 CFR Part 34 Requirements 

                              SOURCE(S) (continued)

Model         Manufacturer            Status      Description

A424-22       AMERSHAM                ACTIVE      Co-60 220Ci, Cs-137
                                                  10.8Ci, Yb-169
                                                  200Ci, Tm-170 50ci,
                                                  Ir-192 240Ci

A424-3        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-4        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-5        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-6        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-7        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50ci,
                                                  Ir-192 240Ci

A424-8        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A424-9        AMERSHAM                ACTIVE      Co-60 220Ci, Cs-137
                                                  30Ci, Yb-169 200Ci,
                                                  Tm-170 50Ci, Ir-192
                                                  240Ci

A453-1        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci

A453-2        AMERSHAM                ACTIVE      Co-60 220Ci, Yb-169
                                                  200Ci, Tm-170 50Ci,
                                                  Ir-192 240Ci.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 6 of 8


                                                   11/21/95


              List of Models That Meet 10 CFR Part 34 Requirements 

                              SOURCE(S) (continued)

Model         Manufacturer            Status      Description
A58101-8      AMERSHAM                ACTIVE      Ir-192 240Ci
B-16F         SPEC                    ACTIVE      Ir-192 100ci
B-16T         SPEC                    ACTIVE      Ir-192 100Ci
C-990         NORDION                 ACTIVE      Ir-192 140Ci
G-11F         SPEC                    UNKNOWN
G-13F         SPEC                    UNKNOWN
G-15F         SPEC                    UNKNOWN
G-17F         SPEC                    UNKNOWN
G-19F         SPEC                    ACTIVE      Co-60 110Ci

G-IF          SPEC                    ACTIVE      Ir-192 240Ci

G-IT          SPEC                    UNKNOWN
G-21F         SPEC                    ACTIVE      Co-60110Ci
G-23          SPEC                    ACTIVE      Ir-192 240Ci
G-36          SPEC                    ACTIVE      Ir-192 240Ci
G-37F         SPEC                    ACTIVE      Co-60 110Ci
G-38          SPEC                    ACTIVE      Ir-192 240Ci
G-3F          SPEC                    ACTIVE      Ir-192 240Ci
G-40F         SPEC                    ACTIVE      Ir-192 240Ci
G-40T         SPEC                    ACTIVE      Ir-192 240Ci
G-41F         SPEC                    ACTIVE      Ir-192 240Ci
G-41T         SPEC                    ACTIVE      Ir-192 240Ci
G-42          SPEC                    UNKNOWN
G-50F         SPEC                    UNKNOWN
G-50T         SPEC                    UNKNOWN
              SPEC                    ACTIVE      Ir-192 240Ci.
                                      Attachment 1
                                      IN 95-58
                                      December 18, 1995
                                      Page 7 of 8

                                      11/21/95


              List of Models That Meet 10 CFR Part 34 Requirements

                              SOURCE(S) (continued)


Model         Manufacturer            Status      Description

  G-9F        SPEC                    UNKNOWN
  N-23        SPEC                    INACTIVE    Ir-192 100Ci

  T-1         SPEC                    ACTIVE      Ir-192 140ci
  T-1F        SPEC                    ACTIVE      Ir-192 140Ci
  T-2F        SPEC                    INACTIVE    Ir-192 140Ci
  T-5         SPEC                    ACTIVE      Ir-192 140Ci
  T-5F        SPEC                    ACTIVE      Ir-192 140Ci
  T-6         SPEC                    ACTIVE      Ir-192 140Ci
  T-7F        SPEC                    INACTIVE    Ir-192 140Ci
                                   CHANGER(S)

Model         Manufacturer            Status      Description
  500-SU      AMERSHAM                INACTIVE    IR-192 120CI, DU 18
                                                  KG

  650L        AMERSHAM                ACTIVE      IR192 240CI,CO60
                                                  120mCI, CS137
                                                  10.8CI, YB169
                                                  40CI, TM170 400CI,
                                                  DU 42 LBS

  770         AMERSHAM                ACTIVE      CO-60 550CI, DU 161
                                                  KG

  771         AMERSHAM                ACTIVE      CO-60 110CI, DU 97
                                                  KG

  820         AMERSHAM                ACTIVE      Ir-192 1000Ci, DU
                                                  100 kg.                                                  Attachment 1
                                                  IN 95-58
                                                  December 18, 1995
                                                  Page 8 of 8

                                                  11/21/95



              List of Models That Meet 10 CFR Part 34 Requirements


                             CHANGER(S) (continued)



Model                Manufacturer           Status     Description


850                  AMERSHAN               ACTIVE     IR-192 24OCI, DU 22
                                                       KG

855                  AMERSHAM               ACTIVE     IR-192 960CI, DU 57
                                                       KG

C-1                  SPEC                   ACTIVE     IR-192 100CI, DU 17KG

Page Last Reviewed/Updated Monday, November 18, 2013