[Federal Register Volume 68, Number 135 (Tuesday, July 15, 2003)]
[Proposed Rules]
[Pages 41757-41760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17846]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 34

[Docket No. PRM-34-5]


Amersham Corporation (Now Known as AEA Technology QSA, Inc.); 
Denial of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of petition for rulemaking.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking (PRM-34-5) submitted by Amersham Corporation (now known 
as AEA Technology QSA, Inc.). The petitioner requested that the NRC 
amend its regulations that specify performance requirements for 
industrial radiography equipment by removing the reference to 
associated equipment, clarifying provisions in the current regulations 
that the petitioner believes are not clearly defined, and by requiring 
routine inspection and maintenance of associated equipment.
    The NRC reviewed the petitioner's request and concluded that 
rulemaking is not necessary to achieve the intent of the petitioner's 
request to remove associated equipment from the sealed source and 
device (SSD) evaluation and registration process for manufacturers of 
industrial radiography equipment in 10 CFR 32.210, ``Registration of 
product information.'' The NRC also explored rulemaking to amend its 
regulations for self-certification of associated equipment to authorize 
manufacturers

[[Page 41758]]

or industrial radiography licensees to complete the radiation safety 
evaluation of associated equipment. The NRC obtained risk information 
that did not clearly support self-certification of associated 
equipment. The NRC disagreed with the petitioner's point that NRC 
inappropriately uses American National Standards Institute (ANSI), 
N432-1980, ``Radiological Safety for the Design and Construction of 
Apparatus for Gamma Radiography,'' (ANSI N432) as a regulatory 
checklist when the standard was originally intended to serve as 
guidance for good manufacturing practices. The NRC determined that its 
regulations are performance-based in this regard. Section 34.20 allows 
modification of associated equipment by a licensee or manufacturer 
unless the replacement component would compromise the design safety 
features of the system. Finally, Sec.  34.31 requires routine 
inspection and maintenance of associated equipment. Therefore, 
additional rulemaking is not warranted.

ADDRESSES: Copies of the petition for rulemaking, the public comments 
received, and NRC's letter to the petitioner may be examined at the NRC 
Public Document Room, Public File Area O1F21, 11555 Rockville Pike, 
Rockville, MD. These documents also may be viewed and downloaded 
electronically via the rulemaking Web site.
    The NRC maintains an Agencywide Document Access and Management 
System (ADAMS), which provides text and image files of NRC's public 
documents. These documents may be accessed through the NRC's Public 
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC 
Public Document Room (PDR) Reference staff at 1-800-397-4209, 301-415-
4737, or by e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Thomas Young, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-5795, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION: 

The Petition

    On June 18, 1996 (61 FR 30837), the NRC published a notice of 
receipt of a petition for rulemaking filed by the Amersham Corporation 
(now known as AEA Technology QSA, Inc.). The petitioner requested that 
the NRC amend its regulations in 10 CFR 34.20, ``Performance 
requirements for industrial radiography equipment,'' by removing the 
reference to ``associated equipment'' in Sec.  34.20. The petitioner 
believes that associated equipment should not be subject to the SSD 
review process. The petitioner argued that the radiation safety 
evaluation and registration under Sec.  32.210 apply specifically to 
SSDs and do not apply to other equipment. The petitioner asserted that, 
for industrial radiography equipment, the NRC expanded its 
interpretation of Sec.  32.210 to include associated equipment and such 
an interpretation is not appropriate without rulemaking. The petitioner 
pointed out that NRC's interpretation, which requires licensees to 
ensure that associated equipment has been registered under Sec.  
32.210, has added unnecessary regulatory burden. Additionally, the 
petitioner wanted the American National Standards Institute (ANSI), 
N432-1980, ``Radiological Safety for the Design and Construction of 
Apparatus for Gamma Radiography,'' (ANSI N432) which is incorporated by 
reference in Sec.  34.20, to be used as guidance for good manufacturing 
practices and not as a regulatory approval checklist. The petitioner 
also requested that Sec.  34.28 be amended to reflect appropriate 
inspection and maintenance requirements for all of the radiography 
equipment, including ``associated equipment.'' Finally, the petitioner 
pointed out that the current version of Sec.  34.20 only requires that 
the equipment meet the performance standards in ANSI N432 and does not 
state that this involves regulatory approvals.

Public Comments on the Petition

    The notice of receipt of the petition for rulemaking invited 
interested persons to submit comments. The comment period closed on 
September 30, 1996. NRC received eight comment letters from industry, 
individuals, and an Agreement State. The majority of the commenters 
supported the petition. The main reasons cited by these commenters were 
related to excessive costs in replacing associated equipment that was 
already fit for use and would not need to be replaced for any other 
reason. The NRC's interpretation of the rule required licensees to 
replace unregistered equipment with equipment that had been registered 
under Sec.  32.210 after prototype testing of the equipment 
demonstrated that the equipment met the performance requirements in 
ANSI N432, which is incorporated by reference in Sec.  34.20.
    Since the comment period closed, NRC has explored the concept of 
licensee or manufacturer self-certification of associated equipment 
with members of industry and counterparts in the Agreement States. The 
NRC completed the generic assessment and special team inspections 
published in NUREG-1631, ``Source Disconnects Resulting from 
Radiography Drive Cable Failures'' (June 1998). An NRC contractor used 
performance criteria in Sec.  34.20 to complete tests on portable 
industrial radiography systems described in NUREG/CR-6652, ``Safety 
Testing of Industrial Radiography Devices,'' (January 2000). An NRC 
contractor provided a risk assessment to compare regulation of 
associated equipment under various regulatory approaches. The NRC 
developed a risk-informed and more performance-based approach for self-
certification of associated equipment and asked the Agreement States to 
evaluate the approach. During the time since the comment period closed, 
NRC monitored the use of associated equipment via various sources of 
information, such as inspection reports, event notifications, and 
enforcement actions.

Reasons for Denial

    Over the last several years, NRC has completed several analyses 
that indicated rulemaking is not necessary to achieve the intent of the 
petitioner's request; therefore, NRC is denying the petition for the 
following reasons.
    1. Current NRC regulations do not require associated equipment to 
be registered and the regulations are sufficient to maintain safety. 
The NRC determined that the practice of registering associated 
equipment under Sec.  32.210 was not only not required, but was also an 
unnecessary regulatory burden. Therefore, NRC has discontinued the 
practice of registering associated equipment and will align NRC's 
implementation by revising the appropriate guidance and inspection 
procedure and will issue a regulatory issue summary (RIS) to convey 
these changes to the regulated community.
    2. Although Sec.  34.20(a)(1) states that associated equipment must 
meet the performance requirements in ANSI N432, Sec.  34.20(b)(3) 
allows a licensee to modify associated equipment, unless the design of 
any replacement component would compromise the design safety features 
of the system. The NRC has dealt with the issue of requiring 
performance criteria in 10 CFR Part 34 for several decades, as follows.
    The Advance Notice of Proposed Rulemaking published March 27, 1978 
(43 FR 12718) announced the NRC's intention to complete rulemaking to

[[Page 41759]]

improve safety by including radiography equipment performance 
requirements in the regulations. ANSI N432 was being developed at that 
time and was issued in 1981. In 1980, an ad hoc Radiography Steering 
Committee composed of NRC personnel and State officials representing 
the Conference of Radiation Control Program Directors, Inc., was formed 
to draft recommendations for improving radiation safety. The steering 
committee developed recommendations for radiography equipment design 
safety that were similar to the performance criteria in ANSI N432. 
Because it appeared that all manufacturers of radiography equipment 
were not using ANSI N432 nor uniformly or completely implementing the 
performance criteria, NRC concluded that rulemaking was necessary to 
ensure that manufacturers would implement ANSI N432 to improve 
radiation safety for workers. The NRC published the final rule on 
January 10, 1990; 55 FR 843 that incorporated by reference ANSI N432 
into Sec.  34.20. Incorporation by reference is the formal process that 
allows the NRC to refer to industry standards that are already 
published elsewhere and that need to be available to afford fairness 
and uniformity in the administrative process. Incorporation by 
reference substantially reduced the volume of material to be published 
in the rule. As referenced in Sec.  34.20, ANSI N432 has the force of 
law and is treated as if it were published in full in the Federal 
Register.
    To maintain safety, a licensee must ensure that prototype testing 
of all associated equipment (including customized associated equipment) 
meets the performance requirements of ANSI N432. This requirement 
prevents substandard associated equipment from being developed by a 
licensee. Alternatively, under Sec.  34.20(a)(2), a licensee may submit 
an engineering analysis to NRC for review without repeating a prototype 
test for similar associated equipment. This performance-based approach 
is a key factor for denying the petitioner's request regarding the 
implementation of ANSI N432.
    3. At the time of the petitioner's request to amend Sec.  34.28 in 
1996, NRC had already proposed rulemaking for routine inspection and 
maintenance of associated equipment. NRC published the overall revision 
of 10 CFR part 34 (May 28, 1997; 62 FR 28948) to incorporate Sec.  
34.31, ``Inspection and maintenance of radiographic exposure devices, 
transport and storage containers, associated equipment, source 
changers, and survey instruments,'' that contains performance-based 
requirements to ensure that associated equipment will function as 
designed. Currently, Sec.  34.31 requires the licensee to perform 
visual and operability checks on associated equipment before use on 
each day that the equipment is to be used to ensure that the equipment 
is in good working condition. If equipment problems are found, the 
equipment must be removed from service until repaired. Section 34.31 
also requires the licensee to have written procedures for inspection 
and routine maintenance of associated equipment at intervals not to 
exceed three months, or before the first use thereafter to ensure the 
proper functioning of components important to safety. If equipment 
problems are found, the equipment must be removed from service until 
repaired. Replacement components must meet design specifications.
    NRC obtained risk information for the regulation of associated 
equipment under Sec.  34.20 and applied the screening considerations in 
SECY-00-0213, ``Risk-Informed Regulation Implementation Plan'' (October 
2000), to determine that the petitioner's request was amenable to a 
risk-informed approach. An NRC contractor provided risk information 
that concluded as long as associated equipment is manufactured to meet 
the performance requirements of a national standard (i.e., ANSI N432), 
the regulation is sufficient to maintain safety as written.
    NRC discontinued the practice of registering associated equipment 
under Sec.  32.210 to reduce, what NRC determined to be, unnecessary 
regulatory burden. The NRC will revise the appropriate guidance and 
inspection procedure and will issue a RIS to replace the existing 
information notice to align NRC's implementation of Sec.  34.20(a)(1) 
as follows:
    1. As a matter of convenience for manufacturers and their 
customers, a manufacturer may register associated equipment under the 
Sec.  32.210 process, but is not required to do so. For example, if a 
manufacturer's application to register a device also designates the 
model numbers for associated equipment to be used with the device, then 
NRC will also indicate the model numbers for the associated equipment 
in the registration certificate for the device so that the customer 
understands which model of associated equipment is compatible with the 
device. For the radiation safety evaluation of a sealed source and 
device combination under Sec.  32.210(c), all the components of an 
industrial radiography system must be evaluated together to ensure that 
there is no interference with the sealed source or the device or 
degradation of safety for the system over the expected life cycle of 
the system. A manufacturer may register an entire system comprised of 
compatible components (including associated equipment) or various 
sealed source and device combinations (excluding associated equipment). 
The NRC does not intend to revise current registrations for industrial 
radiographic equipment to remove references to associated equipment.
    2. NRC will revise NUREG-1556, Volume 2, ``Consolidated Guidance 
about Materials Licensees--Program-Specific Guidance about Industrial 
Radiography Licenses,'' (Final Report, August 1998) to remove 
statements that indicate that associated equipment must be specifically 
approved or registered by NRC or an Agreement State. Instead, the 
guidance will state that manufacturers or distributors of industrial 
radiography equipment may voluntarily include items of associated 
equipment that are compatible with their sealed sources and devices 
when they are registered. Appendix F contains Information Notice 96-20, 
``Demonstration of Associated Equipment Compliance with 10 CFR 34.20,'' 
(IN-96-20) that will be replaced by a RIS.
    3. NRC will revise Inspection Procedure 87121, ``Industrial 
Radiography Programs'' (December 31, 2002). Currently, the procedure 
appropriately directs an inspector to examine available associated 
equipment, interview the workers about inspection and maintenance 
procedures and awareness that associated equipment needs to comply with 
Sec.  34.20, and observe work in progress that involves use of 
associated equipment. An additional statement is needed to prompt an 
inspector to consider the licensee's equipment modification process to 
confirm that the design safety features of the system were not 
compromised by a replacement component of associated equipment that was 
modified by the licensee (i.e., either the licensee or manufacturer 
completed prototype testing that demonstrated the component met the 
performance criteria in ANSI N432 or NRC or an Agreement State has 
reviewed an engineering analysis of the modification).
    4. NRC will issue a RIS to replace IN-96-20 and emphasize a more 
performance-based approach to make it clear that:
    [sbull] Manufacturers of industrial radiography equipment may, but 
are not required to, designate compatible components (including 
associated equipment) for use with their sealed

[[Page 41760]]

sources and devices that are registered under the Sec.  32.210 process;
    [sbull] Under Sec.  34.20(b)(3), a licensee is allowed to modify 
associated equipment unless the design of any replacement component 
would compromise the design safety features of the system;
    [sbull] A licensee's modification process must account for 
prototype testing or engineering analysis of a replacement component 
against the performance criteria required in Sec.  34.20 for any 
component that was modified for use in licensed activities;
    [sbull] To comply with Sec.  34.20, a licensee should demonstrate 
that modifications to associated equipment: (1) Will not create 
material incompatibility that may degrade a source or device over their 
expected useful life times; (2) will not diminish the performance of 
associated equipment in expected use environments over the expected 
life time of the associated equipment; (3) will not allow a source to 
inadvertently exit the system; and (4) will not compromise expected 
safe use of the system; and
    [sbull] Enforcement action would be considered for a licensee who 
completes modification of associated equipment that compromises the 
design safety features of the system. The NRC Enforcement Policy 
(NUREG-1600) includes an example involving possession or use of 
unauthorized equipment which degrades safety in the conduct of licensee 
activities.
    The NRC has determined that alignment of the NRC implementation to 
the existing NRC requirements maintains the same level of compatibility 
between the Agreement State regulations and the existing NRC 
requirements. Also, use of revised NRC guidance rather than rulemaking 
to achieve the petitioner's intent provides Agreement States the 
flexibility to revise their policy and guidance to meet unique 
situations and local conditions.
    In conclusion, no new information has been provided by the 
petitioner that calls into question the requirements. Existing NRC 
regulations provide the basis for reasonable assurance that the common 
defense and security and public health and safety are adequately 
protected; therefore, rulemaking does not appear to be warranted.

    For the reasons cited in this document, the NRC denies this 
petition.

    Dated at Rockville, Maryland, this 9th day of July, 2003.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 03-17846 Filed 7-14-03; 8:45 am]
BILLING CODE 7590-01-P