Terrence O. Hee, Ion Technology; Denial of Petition for Rulemaking, 51786-51788 [06-7284]
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Proposed Rules
Federal Register
Vol. 71, No. 169
Thursday, August 31, 2006
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.
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 40
[Docket No. PRM–40–29]
Terrence O. Hee, Ion Technology;
Denial of Petition for Rulemaking
U.S. Nuclear Regulatory
Commission.
ACTION: Denial of petition for
rulemaking.
erjones on PROD1PC72 with PROPOSALS
AGENCY:
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: https://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 https://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:
pdr@nrc.gov.
FOR FURTHER INFORMATION CONTACT:
Torre Taylor, Office of Nuclear Material
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12:18 Aug 30, 2006
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Safety and Safeguards, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, telephone (301) 415–
7900, e-mail: tmt@nrc.gov.
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
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Sfmt 4702
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 radiationemitting 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
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Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 / Proposed Rules
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.
erjones on PROD1PC72 with PROPOSALS
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
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12:18 Aug 30, 2006
Jkt 208001
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
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51787
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
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Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 / Proposed Rules
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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[COTP San Diego 06–055]
RIN 1625–AA00
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
erjones on PROD1PC72 with PROPOSALS
SUMMARY: The Coast Guard proposes to
establish a temporary safety zone within
the Lake Moovalya Region on the
navigable waters of the Colorado River
in Parker, Arizona for the Blue Water
Resort and Casino 60th Thanksgiving
Regatta. This temporary safety zone is
necessary to provide for the safety of the
participants, crew, spectators, sponsor
vessels of the race, and general users of
the waterway. Persons and vessels are
VerDate Aug<31>2005
12:18 Aug 30, 2006
Jkt 208001
Request for Comments
We encourage you to participate in
this rulemaking by submitting
comments and related material. If you
do so, please include your name and
address, identify the docket number for
this rulemaking COTP San Diego 06–
055, indicate the specific section of this
document to which each comment
applies, and give the reason for each
comment. Please submit all comments
and related material in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying. If you would like
to know they reached us, please enclose
a stamped, self-addressed postcard or
envelope. We will consider all
comments and material received during
the comment period. We may change
this proposed rule in view of them.
Public Meeting
Safety Zone; Blue Water Resort and
Casino 60th Thanksgiving Regatta,
Colorado River, Parker, AZ
ACTION:
prohibited from entering into, transiting
through, or anchoring within this safety
zone unless authorized by the Captain
of the Port, or his designated on-scene
representative.
DATES: Comments and related material
must reach the Coast Guard on or before
October 2, 2006.
ADDRESSES: You may mail comments
and related material to U.S. Coast Guard
Sector San Diego, Waterways
Management, 2710 N. Harbor Drive, San
Diego, CA 92101–1064. Waterways
Management maintains the public
docket for this rulemaking. Comments
and material received from the public,
as well as documents indicated in this
preamble as being available in the
docket, will become part of this docket
and will be available for inspection or
copying at Waterways Management
between 8 a.m. and 3 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
´
Lieutenant Junior Grade Jose Caballero,
USCG, c/o U.S. Coast Guard Captain of
the Port, at (619) 278–7277.
SUPPLEMENTARY INFORMATION:
We do not now plan to hold a public
meeting. But you may submit a request
for a meeting by writing to Waterways
Management at the address under
ADDRESSES explaining why one would
be beneficial. If we determine that one
would aid this rulemaking, we will hold
one at a time and place announced by
a later notice in the Federal Register.
Background and Purpose
The Southern California Speedboat
Club is sponsoring the Blue Water
Casino and Resort 60th Thanksgiving
Regatta, which is held on the Lake
Moovalya region on the Colorado River
in Parker, AZ. This temporary safety
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zone is necessary to provide for the
safety of the participants, crew,
spectators, sponsor vessels, and other
users of the waterway.
This event involves powerboats racing
along a circular track in the Lake
Moovalya region of the Colorado River.
The size of the boats varies from 11 to
21 feet. Approximately sixty to eighty
boats will participate in this event. The
sponsor has provided two (2) water
rescue and three (3) patrol vessels to
patrol this event.
Discussion of Proposed Rule
The proposed temporary safety zone
would be comprised of the following
area: that portion of the navigable
waterway of Lake Moovalya from
Headgate Dam to 0.5 nautical miles
north of Blue Water Marina, Parker,
Arizona.
The Coast Guard proposes to establish
one (1) safety zone that will be enforced
from 6 a.m. to 6 p.m. from November 24,
2006 through November 26, 2006. This
safety zone is necessary to provide for
the safety of the crews, spectators, and
participants of the Blue Water Casino
and Resort Thanksgiving Regatta and to
protect other vessels and users of the
waterway. Persons and vessels will be
prohibited from entering into, transiting
through, or anchoring within this safety
zone unless authorized by the Captain
of the Port, or his designated on-scene
representative.
U.S. Coast Guard personnel will
enforce this safety zone. The Coast
Guard may be assisted by other Federal,
State, or local agencies, including the
Coast Guard Auxiliary. Section 165.23
of Title 33, Code of Federal Regulations,
prohibits any unauthorized person or
vessel from entering or remaining in a
safety zone. Vessels or persons violating
this section will be subject to both
criminal and civil penalties.
Regulatory Evaluation
This proposed rule is not a
‘‘significant regulatory action’’ under
section 3(f) of Executive Order 12866,
Regulatory Planning and Review, and
does not require an assessment of
potential costs and benefits under
section 6(a)(3) of that Order. The Office
of Management and Budget has not
reviewed it under that Order.
We expect the economic impact of
this proposed rule to be so minimal that
a full Regulatory Evaluation is
unnecessary.
This determination is based on the
size and location of the safety zone.
Commercial vessels will not be
hindered by the safety zone.
Recreational vessels will not be allowed
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Agencies
[Federal Register Volume 71, Number 169 (Thursday, August 31, 2006)]
[Proposed Rules]
[Pages 51786-51788]
From the Federal Register Online via the Government Printing 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.
========================================================================
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: https://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 https://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:
pdr@nrc.gov.
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:
tmt@nrc.gov.
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]
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