[Federal Register Volume 60, Number 104 (Wednesday, May 31, 1995)]
[Rules and Regulations]
[Pages 28323-28325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13205]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 34
RIN 3150-AF28
Performance Requirements for Radiography Equipment
Agency: Nuclear Regulatory Commission.
Action: Final rule.
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Summary: The Nuclear Regulatory Commission (NRC) is amending the
regulations pertaining to performance requirements for radiography
equipment. The amended provision permits a licensee to use an alternate
value of torque for the performance testing criteria. The specified
torque test for the drive cable that is currently in the regulations is
not practical to meet, given the design of radiographic equipment.
Further, the amendment allows for the use of engineering analysis to
demonstrate that a modest change in an already approved design is
acceptable without the need to perform prototype tests. The amendment
is necessary to relieve licensees from compliance with an impractical
and unnecessary test criterion.
EFFECTIVE DATE: June 30, 1995.
FOR FURTHER INFORMATION CONTACT: Thomas Rich or J. Bruce Carrico,
Office of Nuclear Material Safety and Safeguards, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, telephone (301) 415-7893
or (301) 415-7826.
SUPPLEMENTARY INFORMATION:
Background
On January 10, 1990 (55 FR 843) the U.S. Nuclear Regulatory
Commission published a revision to 10 CFR 34.20. This regulation
required that significant safety improvements be made to radiography
equipment. Some of these are stated explicitly in the regulation and
some are required through an incorporation by reference of American
National Standards Institute N432-1980 (ANSI-N432). All newly
manufactured radiographic exposure devices and associated equipment
acquired by NRC licensees after January 10, 1992, must meet the
requirements specified in 10 CFR 34.20, including the provisions of
ANSI-N432. All equipment in use after January 10, 1996, must meet these
requirements. Vendors of source assemblies, associated equipment, and
radiography exposure devices have registered their designs with the NRC
or an Agreement State. This process allows both the user and regulatory
agency to determine if the equipment meets the applicable safety
requirements. Two vendors are located in Agreement States and three are
under NRC jurisdiction.
It has come to the attention of the NRC staff that one of the test
criteria specified in section 8.9.2(c) of ANSI-N432 is not practical
and cannot be implemented. This test criterion is also not needed for
demonstration of safety, given the current design and use of
radiography equipment. The test in question is a prototype endurance
test of the entire radiography system and, in particular, is intended
to ensure the integrity of the source assembly for 20,000 operating
cycles. The tests have been performed for the specified number of
cycles and at the proper rotational speed, but not at the value of
[[Page 28324]] torque specified in ANSI-N432. The specific torque
translates to approximately 1345 newtons (300 pounds-force) tensile/
compressive load on the teleflex cable. It is apparently not possible
to actually test at the torque values specified in the ANSI standard.
The torque requirement specified in the ANSI test is not a
reasonable standard. First, it exceeds by a considerable amount the
torque that a human can exert on the radiography system while cranking
the source in and out by hand. Second, it would require that the drive
cable (Type 187 teleflex cable used in radiography cameras for the past
decade) be operated beyond the working load recommended by the supplier
of that component. The recommended working load for the standard cable
for 10,000 cycles is less than 583 newtons (130 pounds-force). For
20,000 cycles, which the ANSI endurance test specifies, the working
load would be lower.
The design of the drive cable system in most radiography cameras
has been unchanged for more than a decade. The NRC staff is not aware
of any cable failures as a result of fatigue. Cable failures of this
type would be clearly visible to the radiographer and 10 CFR 34.30
requires reporting to NRC. Based on the good operating experience with
the standard cable and the fact that an individual is highly unlikely
to generate 1345 newtons of force continuously on the cable, the NRC
staff believes that testing equipment to the high torque requirement of
ANSI-N432 is not needed to ensure system safety.
The NRC staff requested the American National Standards Institute
Committee N43, the organization responsible for development of the
standard, to clarify the basis for the test criterion. The committee's
response indicates that the requirement was adopted from an
International Standards Organization standard, that it was not aware of
the severity of the requirement, and that it was not aware of any
manufacturer that has tested equipment to this requirement. Based on
further discussion with the N43's working group subcommittee chairman,
the NRC staff understands that the working group intends to revise the
standard to incorporate a more realistic torque requirement for the
endurance test. However, considering the approval and publication
process, a revised standard would not be issued for at least 18 months.
At that time the NRC staff will evaluate the revised ANSI standard and
consider revising its regulations, if necessary and appropriate for
maintaining public safety, when radiography equipment is used.
The Amendment
Section 34.20 is being amended, first, by inserting a new sentence
in paragraph (a) that will permit an applicant or licensee to submit an
engineering analysis to demonstrate the applicability of previously
performed testing on similar individual radiography equipment
components. This addition codifies a long-standing staff practice in
evaluating radiography equipment. For example, an engineering analysis
can demonstrate that a modest change in design is acceptable without
repeating a prototype test.
Second, because of the flaw in the ANSI standard criteria, the
Commission is amending its regulation in 10 CFR 34.20 to eliminate the
impractical torque test. In its place, a radiography exposure device
and associated systems will be considered to be in compliance with the
performance requirements if the prototype equipment was tested using a
value of a torque representative of the torque that an individual using
the radiography equipment can realistically exert, provided the
exposure device and associated equipment are in compliance with all
other criteria in the referenced ANSI standard. To accomplish this
objective, a new paragraph (f) is being added to 10 CFR 34.20, to
specify that compliance with the ANSI-N432-1980 torque value for the
endurance test is not required, and that use of a realistic torque
value will satisfy the performance requirement. Furthermore, all
radiography equipment currently shown and sold by vendors meeting the
current part 34 requirements, will meet the revised Sec. 34.20. These
vendors have previously provided test results or engineering analysis
to either the Agreement State or NRC to demonstrate the products meet
Sec. 34.20. The revision imposes a practical performance requirement
that is consistent with industry practice while meeting NRC's objective
to provide radiographers with safe equipment. Therefore, the filing of
additional information with the Commission to demonstrate compliance
with the revised Sec. 34.20 requirement is not necessary.
The Commission finds that public comment on this rule is
unnecessary because the purpose of the rule is to remove from the
regulations an impractical requirement and to stipulate in its stead a
practical standard that will permit continued use of a specific
component, the drive cable, of industrial radiography equipment long in
use without violating the Commission's regulation. The rule change
preserves the status quo for the particular component.
Compatibility of Agreement State Regulations
Section 34.20 is currently designated as a Division II Matter of
Compatibility for Agreement State regulations. The revisions addressed
in this rule correct a flaw in the regulations. The rule does not
affect the current compatibility designations and therefore, 10 CFR
34.20 continues to be designated as a Division II Matter of
Compatibility.
Environmental Impact: Categorical Exclusion
The NRC has determined that this final rule is the type of action
described in categorical exclusion 10 CFR 51.22(c)(2). Therefore,
neither an environmental impact statement nor an environmental
assessment has been prepared for this rule.
Paperwork Reduction Act Statement
This final rule does not contain a new or amended information
collection requirement subject to the Paperwork Reduction Act of 1980
(44 U.S.C. 3501 et seq.). Existing requirements were approved by the
Office of Management and Budget approval number 3150-0007.
Regulatory Analysis
The NRC has prepared this final rule to cure a defect in its
regulations that places an unnecessary and unwarranted burden on
certain of its licensees that use sources and devices for radiography.
There is no other procedure available to the NRC to efficiently and
effectively rectify the matter. There is no cost to the licensed and
regulated community in the promulgation of this rule. This discussion
constitutes the regulatory analysis for this rule.
Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this final rule, and therefore, that a backfit analysis is
not required for this final rule because these amendments do not
involve any provisions that would impose backfits as defined in 10 CFR
50.109(a)(1).
List of Subjects in 10 CFR Part 34
Criminal penalties, Incorporation by reference, Packaging and
containers, Radiation protection, Radiography, Reporting and
recordkeeping requirements, Scientific equipment, Security measures.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended, [[Page 28325]] the Energy
Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the
Commission is adopting the following amendments to 10 CFR Part 34.
PART 34--LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS
FOR RADIOGRAPHIC OPERATIONS
1. The authority citation for Part 34 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
Section 34.32 also issued under sec. 206, 88 Stat. 1246 (42
U.S.C. 5846).
2. Section 34.20 is amended by revising paragraph (a) and adding a
new paragraph (f) to read as follows:
Sec. 34.20 Performance requirements for radiography equipment.
* * * * *
(a) Each radiographic exposure device and all associated equipment
must meet the requirements specified in American National Standards
Institute N432-1980, ``Radiological Safety for the Design and
Construction of Apparatus for Gamma Radiography,'' (published as NBS
Handbook 136, issued January 1981). This publication has been approved
for incorporation by reference by the Director of the Federal Register
in accordance with 5 U.S.C. 552(a). This publication may be purchased
from the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402. Copies of the document are available for
inspection at the Nuclear Regulatory Commission library, 11545
Rockville Pike, Rockville, Maryland, 20852-2738. A copy of the document
is also on file at the Office of the Federal Register, 800 North
Capitol Street NW., Suite 700, Washington, DC 20408.
Engineering analyses may be submitted by an applicant or licensee
to demonstrate the applicability of previously performed testing on
similar individual radiography equipment components. Upon review, the
Commission may find this an acceptable alternative to actual testing of
the component pursuant to the referenced standard.
* * * * *
(f) Notwithstanding paragraphs (a), (d), and (e) of this section,
equipment used in industrial radiographic operations need not comply
with section 8.9.2(c) of the Endurance Test in American National
Standards Institute N432-1980, if the prototype equipment has been
tested using a torque value representative of the torque that an
individual using the radiography equipment can realistically exert on
the lever or crankshaft of the drive mechanism.
Dated at Rockville, MD, this 17th day of May, 1995.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 95-13205 Filed 5-30-95; 8:45 am]
BILLING CODE 7590-01-P
