[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]
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