[Federal Register Volume 71, Number 169 (Thursday, August 31, 2006)]
[Proposed Rules]
[Pages 51786-51788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7284]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 /
Proposed Rules
[[Page 51786]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 40
[Docket No. PRM-40-29]
Terrence O. Hee, Ion Technology; Denial of Petition for
Rulemaking
AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a
petition for rulemaking (PRM-40-29) submitted by Terrence O. Hee, Ion
Technology. The petitioner requested that the NRC amend its regulations
regarding unimportant quantities of source material to exempt end users
of a catalytic device containing thorium from the NRC's licensing
requirements.
ADDRESSES: Publicly available documents related to this petition may be
viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee. Selected documents, including comments,
may be viewed and downloaded electronically via the NRC rulemaking Web
site at: http://ruleforum.llnl.gov.
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
PDR Reference staff at: 1-800-397-4209, 301-415-4737, or by e-mail to:
[email protected].
FOR FURTHER INFORMATION CONTACT: Torre Taylor, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone (301) 415-7900, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
The Petition
On October 15, 2003, (68 FR 59346), the NRC published a notice of
receipt of a petition for rulemaking filed by Terrence O. Hee, Ion
Technology. The petitioner requested that the NRC amend its regulations
in 10 CFR 40.13, ``Unimportant quantities of source material,'' to
exempt end users from NRC's regulatory requirements to the extent that
such person receives, possesses, uses or transfers, any patented
catalytic device containing thorium.
The petitioner stated that the device is part of a ``new technology
for the reduction of air pollution chemicals'' produced by mobile and
industrial combustion processes and that granting his petition would
contribute to the reduction in air pollution. Mr. Hee also identified
his monetary interest, as his company has secured distribution rights
for this patented catalytic device in the United States.
The petitioner asserts that there are potentially millions of users
for this device, and that obtaining ``an individual license for each
application would prove to be burdensome for the state agencies issuing
the individual licenses and to those wishing to use the devices.'' The
petitioner requested an exemption in 10 CFR 40.13(c) for his product, a
catalytic device containing thorium. Thorium is a type of source
material licensed by the NRC. The exemptions in 10 CFR 40.13(c) apply
to the end user, who is exempt from the licensing requirements set
forth in section 62 of the Atomic Energy Act. The petitioner suggested
the following language be added to 10 CFR 40.13(c) for the requested
exemption:
Any patented catalyst used in the treatment of fuel, gas or air
streams for combustion processes, or other processes provided that
the thorium content does not exceed 6 percent by weight. The weight
percentage to be calculated for either a homogeneous mixture or as a
coating on a substrate base, with the base and the coating being
considered the same as a homogeneous mixture, and the finished
product is constructed in a manner that will prevent the exposure of
the public to any radiation during the normal application and use of
this technology.
The petitioner offered the following rationale in support of the
petition: (1) The ``environmental and quality of life benefits''
derived from the application of this technology are ``currently enjoyed
by the citizens of Japan.'' The petitioner stated that this technology
is proposed for license in China as a way to reduce air pollution; (2)
Implementation of these devices can reduce the cost of air emissions
pollution control to U.S. industry over the cost of current methods,
thus enhancing the ability of industry to meet strict air emission
standards; (3) Workers involved with the devices will be protected from
the low levels of radiation exposure by a metal housing encasing the
thorium-bearing material; (4) The devices are manufactured in Japan, so
no U.S. workers will have direct contact with the thorium-bearing
material; and (5) The long-term effect on the environment would be
``reduced emissions of air pollutants from mobile and stationary
combustion sources.'' The petitioner also stated that the device
``could also lead to a reduction in the volume of hydrocarbon fuels
used.'' In addition, the petitioner explained that the public is
protected by housings shielding the radiation-emitting material, and
that the housings are designed not to be ``readily disassembled by the
curious.''
The petitioner stated the product will have warning labels which
instruct users in the proper disposal method, which is only by return
of the product to the distributor. The petitioner anticipated that
these labels would prevent long-term negative effects on the
environment. The petitioner noted that disposal instructions would also
be in the ``Material Safety Data Sheet'' delivered with each device.
The petitioner projects the product to have a 30-year life cycle, and
expected no short-term negative effects on the environment from
disposal of the devices. The petitioner believes that the product is a
safe and cost-effective method for contributing to the reduction of air
pollution chemicals in the air in the United States and claims that it
poses no adverse risk to the public or to workers involved in
installing or removing the devices.
The petitioner stated that Honda Motor Company is currently
installing
[[Page 51787]]
the technology as a factory-installed device on their diesel-powered
vehicles, and claims use of this technology in Japan has demonstrated a
reduction of air pollution chemicals and a reduction in fuel
consumption. The petitioner submitted test data showing reductions of
soot emissions after installation of the device on diesel bus engines
on the Okayama Bus Line company and a Caterpillar/Mitsubishi diesel-
powered shovel. The petitioner also submitted data showing reductions
in nitrogen oxides, carbon monoxide, and hydrocarbons for a 1989
gasoline-fueled Mercedes Benz, and similar data for a 1998 Mitsubishi
van. The petitioner also presented ``fuel usage reduction examples''
comparing various makes and models of vehicles before and after
installation of the catalytic device.
The petitioner believes that the proposed change to the
Commission's regulations to allow the use of catalytic devices
containing thorium in the United States is appropriate because it will
benefit citizens by increasing the efficiency of combustion processes,
reducing the use of hydrocarbon fuels, and lowering air pollutant
emissions. The petitioner concludes that this technology poses no
hazard to users or the public.
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
December 29, 2003. NRC did not receive any comments on the petition.
Reasons for Denial
The petition is being denied because the petitioner did not submit
information of sufficient scope and depth for NRC to find that
authorizing this exemption would adequately ensure protection of public
health and safety and the environment.
The NRC staff evaluated the technical merits of the petition for:
(1) The appropriateness of this product for distribution to persons
exempt from licensing and regulatory requirements; (2) Whether public
health and safety would be adequately protected; and (3) The potential
environmental impacts. After reviewing the petition, NRC has determined
that there are unresolved questions related to technical aspects of the
device, safety, and the potential impact to the environment. These
questions would have to be resolved before the petition could be
granted.
To fully evaluate a product designed for distribution to persons
exempt from licensing and regulatory requirements, NRC needs for its
review detailed descriptions and drawings that clearly illustrate the
components of the product, materials of construction, dimensions,
assembly methods, source containment and shielding, operation of the
product and tamper resistance. NRC also needs to review prototype
testing that demonstrates the integrity of the product during normal
use and likely accident conditions (physical testing, engineering
analysis, or operational history). A quality assurance program is also
needed to ensure that the product will be manufactured and distributed
in accordance with the information provided in the application.
This information was not provided by the petitioner, or was not of
sufficient detail for NRC to conduct a thorough evaluation. For
example, while the petitioner provided a description and drawings of
the catalytic device, NRC could not determine the exact materials of
construction, assembly methods, source containment and shielding,
operation of the product and tamper resistance features. Prototype
testing, both methodology and results, was not submitted. Additionally,
the petition did not include any information regarding a quality
assurance program.
The petition did not contain support for all uses of the device
requested in the petition (i.e., buses and industrial facilities). NRC
could not determine the actual isotope of thorium or the amount of
thorium to be used in the device, as different percentages by weight
concentrations were given in different sections of the information
provided.
The petitioner provided statements on the benefit of catalytic
converting devices to substantially reduce air pollution chemicals.
However, there was no data to support the results provided.
Additionally, there was not enough detailed information to support the
claim that the metal housing enclosure which prevents access to
radioactive material is sufficient protection from radiation exposure.
There were statements that the device is designed for a 30 year working
life, with no repair. However, information was provided regarding 5,
10, and 15 year maintenance cycles with no description of what the
maintenance involves.
The petitioner provided a description of the worst case scenario
for an accident condition but did not include a description of other
possible accident conditions during installation and normal use. There
was a summary of radiological impacts under normal and accident
conditions, but there was no description of how this information was
obtained.
As part of the petitioner's request, the petitioner included
language for the proposed amendment to the regulations that limited the
exemption to ``Any patented catalyst * * *'' It is not NRC's practice
to authorize exemptions that are limited to a certain patented device/
product. If NRC determined that a catalytic device containing thorium
was appropriate for distribution to persons exempt from licensing and
regulatory requirements, the exemption would authorize distribution of
such a device/product, regardless of the manufacturer or patent status.
Therefore, anyone that developed a catalytic device that met the
required criteria and any technical and licensing requirements for the
exemption would be authorized to distribute that device/product.
Because the petitioner is requesting an amendment to add an
exemption in 10 CFR 40.13(c), an environmental report is required in
accordance with 10 CFR 51.68. Section 51.68, ``Environmental report--
rulemaking,'' requires petitioners for rulemaking requesting amendments
of certain parts of the regulations concerning exemptions from
licensing and regulatory requirements of any device, commodity or other
product containing source material to submit with the petition a
separate ``Petitioner's Environmental Report.'' The purpose of an
environmental review is to identify and evaluate the potential
environmental impacts associated with a request. NRC's evaluation
relies on information provided by the petitioner, as well as staff's
own independent assessment. As part of the environmental review,
several issues are evaluated: (1) Why is the action proposed and what
need will it meet; (2) How can the need be met; and (3) What aspects of
the environment would be impacted? Alternatives to a proposed action
are also evaluated. Radiological and non-radiological impacts, as well
as direct, indirect, and cumulative impacts are part of this
environmental review. Staff requested an environmental report from the
petitioner by letter dated May 12, 2004. The environmental report was
submitted by the petitioner in January 2005.
This report failed to include detailed information related to: (1)
Testing conditions and supporting data to evaluate the short-term and
long-term impacts and benefits of the device; (2) Supporting data for
accident analysis, such as accident rates, device failure rates and
modes; (3) Supporting data for assumptions, such as market penetration
and recovery rate; and (4) Data to support how the product would be
more effective or efficient than alternative products. NRC must be able
to independently assess the data
[[Page 51788]]
submitted in support of a petition. NRC was not able to do this with
the information submitted.
The petitioner also stated that there would be label warnings on
the device that instruct any person who handles, uses or comes in
contact with the product to dispose of it only by returning it to the
distributor for safe disposal. Products that are distributed under an
exemption must meet health and safety requirements without any
regulatory requirements on the end user. Therefore, the petition must
address the environmental aspects of disposal of the catalytic device
presuming that none of the devices would be returned to the distributor
for disposal.
In summary, the petitioner did not submit information of sufficient
scope and depth for NRC to determine the adequacy of this product to be
distributed to persons exempt from licensing and regulatory
requirements. NRC could not ensure that the public health and safety,
and the environment, would be protected based on the information
submitted in support of the petition.
For the reasons cited in this document, the NRC denies this
petition.
Dated at Rockville, Maryland, this 18th day of August, 2006.
For the Nuclear Regulatory Commission.
Luis A. Reyes,
Executive Director for Operations.
[FR Doc. 06-7284 Filed 8-30-06; 8:45 am]
BILLING CODE 7590-01-P