Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
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
