[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.

-----------------------------------------------------------------------

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: 
<a href="/cdn-cgi/l/email-protection#463622340628342568212930"><span class="__cf_email__" data-cfemail="21514553614f53420f464e57">[email protected]</span></a>.

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: 
<a href="/cdn-cgi/l/email-protection#b8ccd5ccf8d6cadb96dfd7ce"><span class="__cf_email__" data-cfemail="4f3b223b0f213d2c61282039">[email protected]</span></a>.

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


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