[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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