  SEQ CHAPTER \h \r 1

MEMORANDUM

DATE:		February 15, 2010

SUBJECT:	MACT Floor Determination for Existing Stationary Non-Emergency
CI RICE Less Than 100 HP and Existing Stationary Emergency CI RICE
Located at Major Sources and GACT for Existing Stationary CI RICE
Located at Area Sources

FROM:	Bradley Nelson and Tanya Parise, EC/R, Inc.

TO:		Melanie King, EPA OAQPS/SPPD/ESG

1.0	PURPOSE

The purpose of this memorandum is to document the analysis of the
maximum achievable control technology (MACT) floor and MACT for existing
stationary non-emergency compression ignition (CI) reciprocating
internal combustion engines (RICE) less than 100 horsepower (HP) and
existing stationary emergency and black start CI engines located at
major sources.  The generally achievable control technology (GACT) for
existing stationary CI RICE located at area sources of hazardous air
pollutants (HAP) emissions that are subject to National Emission
Standards for Hazardous Air Pollutants (NESHAP) is also presented in
this memorandum.

The analysis for existing stationary non-emergency CI engines greater
than or equal to 100 HP located at major sources of hazardous air
pollutants (HAP) emissions is presented in a separate memorandum titled
“MACT Floor Determination for Existing Stationary Non-Emergency CI
RICE Greater Than or Equal 100 HP Located at Major Sources,” which is
available in the rulemaking docket (EPA-HQ-OAR-2008-0708).

2.0	INTRODUCTION

The EPA has developed a regulation addressing toxic air emissions from
the following existing stationary CI RICE engines: 1) engines that are
located at area sources of HAP emissions; 2) engines that are less than
or equal to 500 HP and are located at major sources of HAP emissions;
and 3) non-emergency CI engines that are greater than 500 HP and are
located at major sources of HAP emissions.  The regulation was developed
following criteria set forth under section 112 of the Clean Air Act
(CAA).  Section 112(d) of the CAA stipulates that EPA must promulgate
emission standards that require the maximum degree of HAP reduction.
According to 112(d)(3)(A) of the CAA, the emission standards for
existing major sources must be no less stringent than the average
emission limitation achieved by the best performing 12 percent of
existing sources for which the Administrator has emissions information.
For existing area sources, EPA has the option under 112(d)(5) of the CAA
to promulgate emission standards or requirements GACT or management
practices in order to reduce HAP emissions.  The EPA has previously
issued a similar regulation affecting existing and new stationary RICE
greater than 500 HP at major sources, which was promulgated in 2004 and
for new stationary RICE less than or equal to 500 HP at major sources,
which was promulgated in 2008.

Section 112 of the CAA outlines the statutory requirements for the
EPA’s stationary source air toxics program.  Section 112(k) of the CAA
requires the development of standards for area sources which account for
90 percent of the emissions in urban areas of the 33 urban HAP listed in
the Integrated Urban Air Toxics Strategy (UATS).  These area source
standards can require control levels which are equivalent to either MACT
or GACT, as defined in the CAA under section 112(d)(2) and (3) and
section 112(d)(5), respectively.

Section 112 of the CAA allows the EPA to establish subcategories among a
group of sources.  A complete discussion of the subcategory selection is
presented in a separate memorandum.

3.0	MACT FLOOR AND MACT DETERMINATION

Non-Emergency CI Engines <100 HP

	For stationary CI engines less than 100 HP, EPA determined that it is
not feasible to prescribe or enforce an emission standard because the
application of measuring methodologies to this subcategory of engines is
not practicable due to technological and economic limitations.  In order
to measure the CO emissions from these engines in terms of volumetric
concentration on a dry basis and corrected to 15 percent oxygen (O2),
the following test methods are required:

EPA Method 1 or 1A for selection of sampling ports;

EPA Method 3, 3A, or 3B or ASTM Method D6522-00 (2005) for determining
the O2 concentration;

EPA Method 4 for measuring the moisture content; and

EPA Method 10 or ASTM Method D6522-00 (2005) for measuring the carbon
monoxide (CO) concentration.

The test methods require the sample point to be a certain distance
between the engine and the exhaust.  Because engines below 100 HP often
have exhaust pipes with very small diameters and lengths, stack testing
using these methods could require a modification or extension of the
exhaust pipe to accomplish the test.  Furthermore, the cost of
performing a stack test ranges from approximately $1,000-5,000 depending
on the method used.  Generally, 100 HP engines cost around $5,000-$7,000
and 50 HP engines cost approximately $4,000-$5,000, so the cost of
performance testing could approach the cost of the engine itself.  Given
the cost of the testing itself, the physical adjustments necessary to
accomplish the test, and the particular circumstances pertaining to
engines below 100 HP, EPA believes that the application of measurement
methodology to this class of engines is not practicable due to
technological and economic limitations.  Therefore, work practices are
the MACT floor for existing stationary non-emergency CI engines less
than 100 HP.

To determine the work practices, EPA reviewed information obtained from
different manufacturers and operators of CI engines.  The EPA has
determined that the maximum achievable control, based on the work
practices of the best controlled engines, is to maintain and replace the
following stationary engine components:  oil and oil filter, air
cleaner, hoses, and belts.  According to information received from
manufacturers and operators of stationary engines, these parameters are
the most appropriate to ensure proper operation for minimizing HAP
emissions.  Each of these work practices limit HAP emissions by allowing
the engine to operate at peak efficiency.  Changing the oil and oil
filter reduces the wear on the pistons and cylinders and limits the
amount on worn metals that may be introduced to the exhaust stream.
Inspecting the air filter limits the introduction of oil mist and other
contaminants to the combustion chamber.  Inspecting the belts and hoses
ensures that the engines cooling and electrical systems are operating,
therefore eliminating the burning of oil and ensuring that the
electrical systems are functioning as intended.

Intervals for checking, inspecting and replacing the oil and oil filter,
air cleaner, hoses, and belts vary with engine makes and models,
application, location, and other factors, therefore making it difficult
to define specific maintenance intervals that would be represent the
operation of the best controlled engines.  However, EPA must promulgate
specific requirements pursuant to section 112(d) of the CAA and the
information indicates that there are commonalities in maintenance
interval frequencies for the best controlled engines.  Based on the
information provided, EPA believes that the work practices below are
what the best controlled existing stationary non-emergency CI engines
less than 100 HP are currently doing and for that reason the MACT floor
for these engines is work practices as follows:

changing the oil and oil filter every 1,000 hours of operation or
annually, whichever comes first;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

	As discussed above, current maintenance procedures vary from engine to
engine based on a number of factors including engine design, fuel,
operating characteristics, and so on.  Maintaining the oil however, is,
one of the most important activities operators can perform to minimize
emissions and to ensure proper operation and performance.

	In addition to following a set schedule for checking and replacing the
oil, it is also common that the oil is monitored through an oil analysis
program where the oil is periodically sampled to determine oil quality.
Based on the oil sample that is extracted, an oil analysis can be
performed that can indicate if it is time to replace the oil or if the
existing oil has not reached condemning limits it can continue to be
used.  Based on the analysis a decision can be made whether to drain and
replace the oil or if the oil change interval can be extended if the
properties of the oil are within acceptable limits.  Appropriate
parameters and condemning limits that would indicate oil degradation and
the presence and quantity of contaminants varies.  However, EPA has
determined that the parameters that would most appropriately indicate
the oil quality are the total base number (TBN), viscosity, and water
content.  The TBN is an indication of the alkalinity of the oil and the
viscosity of the oil is a measure of how well the oil flows and these
parameters are, along with water content, measures of the condition of
the oil.  If the following levels below as measured through an oil
analysis program are exceeded, EPA has determined that an oil change
must be performed:

TBN is less than 30 percent of the TBN of the oil when new; or

viscosity of the oil has changed by more than 20 percent from the
viscosity of the oil when new; or

percent water content (by volume) is greater than 0.5.

	No other regulatory options beyond the MACT floor were identified as
appropriate for existing stationary non-emergency CI engines below 100
HP.  Therefore, MACT for HAP emissions is equivalent to the MACT floor
for these engines.

Emergency CI Engines

	For existing stationary CI emergency engines located at major sources,
EPA determined it is not feasible to prescribe or enforce an emission
standard because the application of measurement methodology to this
class of engine is impracticable due to the technological and economic
limitations.  Emergency engines typically only operate during
emergencies or during periods of routine testing and maintenance.  EPA
determined that application of the emissions measurement methodologies
during either of these periods is not practicable.  It is impracticable
to test emissions from stationary CI emergency engines during periods of
routine testing and maintenance using the test procedures specified in
the rule because it would increase the required number of hours of
operation of the engine beyond the routinely scheduled reliability
testing and maintenance operation, thereby increasing emissions.  While
emergency engines have periods of operation for scheduled maintenance
and reliability testing, those periods are usually several hours shorter
than the number of hours that would be required to run the necessary
emissions tests under subpart ZZZZ.  CARB conducted a survey of
stationary emergency diesel engines in 2002 to determine the average
number of hours that stationary emergency diesel engines operate.  The
average hours of operation for maintenance and testing were 22 hours per
year, which is less than two hours per month.  For the engines that CARB
surveyed, 86 percent operated less than 30 hours/year for testing and
maintenance.  Thirty percent operated less than 10 hours/year.  National
Fire Protection Association (NFPA) codes require that stationary diesel
engines that are used for emergency purposes are run 30 minutes per week
(27 hours per year) for maintenance and testing purposes.  It is also
impracticable to apply the testing methodologies required in this rule
to test the stationary engines during periods of emergency operation
because emergencies are unplanned events and and implementation of the
procedures specified in subpart ZZZZ require advance planning before
tests are conducted.  In an emergency, the owner/operator does not have
the advance planning time necessary to implement subpart ZZZZ.  It is
also impracticable to test stationary CI emergency engines at major
sources because of the large population of these engines.  EPA estimates
that there are over 200,000 existing stationary CI emergency engines
from 100-500 HP at major sources that are subject to this rulemaking.
There are only approximately 300-400 testing firms and these stationary
engines are not the only sources that are required to be tested, so if
testing were required for these engines, it would take many years to
test all of these engines.  The cost for testing all of these engines
would be in excess of $200 million and would clearly also be
unreasonable.

For these reasons, work practices are appropriate and justified for this
group of stationary engines because the application of measurement
methodology is not practicable due to technological and economic
limitations.  Consequently, work practices are the MACT floor for
existing stationary emergency CI engines located at major sources.

Again, in order to determine the work practices for stationary emergency
engines at major sources, EPA reviewed information obtained from
different manufacturers and operators of CI engines.  For the same
reasons as discussed above for existing stationary non-emergency engines
less than 100 HP at major sources, EPA has determined that maximum
achievable control, based on the work practices of the the best
controlled emergency engines, is to maintain and replace the following
stationary engine components:  oil and oil filter, air cleaner, hoses,
and belts.  EPA discussed above the effect that maintaining these
parameters have on HAP emissions.

As stated, intervals for checking, inspecting and replacing these
components vary from engine to engine and determining specific
maintenance intervals that would be represent the operation of the best
controlled emergency engines is challenging.  However, EPA must
promulgate specific requirements pursuant to section 112(d) of the CAA
and the information indicates that there are commonalities in
maintenance interval frequencies for the best controlled engines.  Based
on the information provided, EPA believes that the below maintenance
practices are what the best controlled existing stationary emergency CI
engines are currently doing and for that reason, the MACT floor for
these engines is maintenance practices as follows:

changing the oil and oil filter every 500 hours of operation or
annually, whichever comes first;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

The changing of oil and the oil filter for stationary emergency engines
is more frequent on an hourly basis than for non-emergency engines
because of the nature of operation of these engines, which is for
standby and intermittent use, and thus requires less hourly use over the
same period of time, and oil quality is reduced over time even during
periods when the engine is not used.

	Emergency CI engines also have the option to use an oil analysis
program to indicate if it is time to replace the oil or if the existing
oil has not reached condemning limits it can continue to be used.  The
provisions of the oil analysis program are the same discussed above for
non-emergency CI engines <100 HP.

 No other regulatory options beyond the MACT floor were identified as
appropriate for existing stationary emergency CI engines at major
sources.  Because these engines are typically used only a few number of
hours per year, the costs of emission control are not warranted when
compared to the emission reductions that would be achieved.  The cost
per ton estimates for stationary emergency CI engines can be found in
the memorandum entitled “Cost per Ton of HAP Reduced for Existing
Stationary CI RICE” in the rulemaking docket (EPA-HQ-OAR-2008-0708).
Therefore, MACT for HAP emissions is equivalent to the MACT floor for
these engines.

Black Start Engines

	Black start engines are used solely to start up combustion turbines.
They operate for very short durations and have the same issues as
emergency CI engines based on their unique and limited operation.
According to information received during the public comment period,
black start engines typically operate no more than 10 minutes at a time
and only operate during emergencies or during periods of high demand
(see for example EPA-HQ-OAR-2008-0708-0088 and 0129).  The short time of
operation makes testing of black start engines using the required
procedures impracticable.  Therefore, work practices are the MACT floor
for existing stationary black start engines located at major sources and
are as follows:

changing the oil and oil filter every 500 hours of operation or
annually, whichever comes first, with the option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

As with stationary emergency CI engines, no other regulatory options
beyond the MACT floor were identified as appropriate for existing
stationary black start engines at major sources.  The limited operating
time also makes applying aftertreatment to black start engines not
effective.  In addition, these engines operate a few hours per year,
making further regulation of these engines economically impractical.
Therefore, MACT is equivalent to the MACT floor for these engines.

4.0	GACT DETERMINATION

Under CAA section 112(d)(5), EPA may elect to promulgate standards or
requirements for area sources "which provide for the use of generally
available control technologies or management practices by such sources
to reduce emissions of hazardous air pollutants."  Additional
information on generally available control technologies (GACT) or
management practices is found in the Senate report on the legislation
(Senate report Number 101-228, December 20, 1989), which describes GACT
as:

. . . methods, practices and techniques which are commercially available
and appropriate for application by the sources in the category
considering economic impacts and the technical capabilities of the firms
to operate and maintain the emissions control systems.

Determining what constitutes GACT involves considering the control
technologies and management practices that are generally available to
the area sources in the source category.  EPA also considers the
standards applicable to major sources in the same industrial sector to
determine if the control technologies and management practices are
transferable and generally available to area sources.  In appropriate
circumstances, EPA may also consider technologies and practices at area
and major sources in similar categories to determine whether such
technologies and practices could be considered generally available for
the area source category at issue.  Finally, as EPA has already noted,
in determining GACT for a particular area source category, EPA considers
the costs and economic impacts of available control technologies and
management practices on that category.

Emergency CI

For existing stationary emergency CI engines located at area sources,
EPA believes that it is appropriate to set GACT to be the same
requirements as is required for emergency engines at major sources
because the same issues that were discussed above for stationary
emergency CI engines at major sources apply to emergency CI engines at
area sources.  There is no reason why the requirements for engines
located at area sources pursuant to GACT should be different than those
for engines located at major sources.  The management practices are
generally available and being located at an area source does not prevent
the engine from being maintained appropriately and according to how
engines at major sources are being maintained.  Further, the management
practices do not present an economic burden on area source engines and
are for that reason also considered appropriate.  Therefore, GACT for
existing stationary emergency CI engines at area sources is the use of
management practices as follows:

changing the oil and oil filter every 500 hours of operation or
annually, whichever comes first, with an option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

Black Start Engines

For existing stationary black start engines located at area sources, EPA
believes that it is appropriate to set GACT to be the same requirements
as is required for black start engines at major sources because the same
issues that were discussed above for stationary black start engines at
major sources apply to these engines at area sources.  There is no
reason why the requirements for area sources pursuant to GACT should be
different than those for black start engines at major sources.
Therefore, GACT for existing stationary emergency CI engines at area
sources is the use of management practices as follows:

changing the oil and oil filter every 500 hours of operation or
annually, whichever comes first, with an option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

Non-Emergency CI <100 HP

For existing stationary non-emergency CI engines less than 100 HP
located at area sources, EPA believes that it is appropriate to set GACT
to be the same requirements as is required for non-emergency CI engines
less than 100 HP at major sources because the same issues that were
discussed above for stationary non-emergency CI engines less than 100 HP
at major sources apply to non-emergency CI engines less than 100 HP at
area sources.  There is no reason why the requirements for engines
located at area sources pursuant to GACT should be different than the
requirements for engines located at major sources.  Therefore, GACT for
existing stationary non-emergency CI engines less than 100 HP at area
sources is the use of management practices as follows:

changing the oil and oil filter every 1,000 hours of operation or
annually, whichever comes first, with an option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

CI 100≤HP≤300

For existing stationary non-emergency engines between 100 HP and 300 HP,
EPA determined that management practices were appropriate for GACT.
Although add-on controls are technically feasible for these engines
located at area sources, control costs are high and EPA believes that it
is possible to achieve reasonable controls using management practices.
For example, capital costs associated with installing an oxidation
catalyst on a 200 HP diesel engine are about $4,500 with annual costs of
$1,500.  Such costs are significant particularly when one considers that
the cost per ton of this option is as high as $265,000 per ton of HAP
reduced for some engines.  EPA has estimated that there are over 64,000
existing stationary non-emergency engines between 100 HP and 300 HP
located at area sources.  The impacts of requiring add-on controls on
these engines would be more than $320 million for equipment costs alone
and total yearly costs would be more than $105 million, not including
associated costs such as monitoring, testing, reporting, and
recordkeeping that would be necessary in order to ensure compliance with
an emission standard.  For more information on the cost per ton of HAP
reduced, please refer to the memorandum entitled “Cost per Ton of HAP
Reduced for Existing Stationary CI RICE” in the rulemaking docket
(EPA-HQ-OAR-2008-0708).

Furthermore, EPA is attempting to minimize the burden of the proposed
rule, specifically on small businesses and individual owners and
operators.  EPA does not believe that management practices would be a
substantial burden on owners and operators such as home owners and small
entities.  Additionally, the cumulative testing cost that would be
associated with requiring existing non-emergency CI engines between 100
HP and 300 HP at area sources to meet a numerical emission limitation
would be in the vicinity of $37 million.  In addition, there would be
other associated costs with demonstrating compliance with a numerical
emission limit, such as notification and reporting requirements.
Finalizing the same numerical emission limit consistent with the
emission limit finalized for existing non-emergency CI engines between
100 HP and 300 HP at major sources would have possibly resulted in some
existing area source engines having to install aftertreatment.
Purchasing, installing and operating add-on controls would lead to even
further costs, increasing the total burden on these sources.  For
example, assuming that 35 percent of existing stationary non-emergency
CI engines between 100 HP and 300 HP located at area sources would have
to install and operate aftertreatment controls in order to comply with a
numerical emission limit, capital and annual costs would add an
additional $100 million in capital costs and $37 million yearly for
operation and maintenance of the control device.  EPA believes these
costs are excessive and not justified in comparison to the amount of
pollutant that would be reduced with requiring a numerical emission
limit as was done for the same engines at major sources.

Consequently, GACT for existing stationary non-emergency CI engines
between 100 HP and 300 HP at area sources is the use of management
practices as follows:

changing the oil and oil filter every 1,000 hours of operation or
annually, whichever comes first, with an option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

HP≤500

For subcategories of existing stationary non-emergency CI engines
greater than 300 HP, EPA believes that oxidation catalyst is readily
available and feasible for all existing stationary non-emergency CI
engines above 300 HP generally regardless of location.  Further, EPA has
determined that costs associated with implementing HAP-reducing
technologies are reasonable and justified. In addition, it is estimated
that the benefits per ton are between $330,000 (Pope, 7%) and $790,000
(Laden, 7%) for PM2.5 for existing stationary CI engines at area
sources.  For more information on the benefits per ton of PM2.5 emission
reductions, please refer to the Regulatory Impact Analysis for the final
rule, available in the docket.  The benefits per ton outweigh the costs.
 Further information on the specific add-on control costs and cost per
ton estimates can be found in the memorandum “Cost per Ton of HAP
Reduced for Existing Stationary CI RICE,” available from the docket
(EPA-HQ-OAR-2008-0708).  Therefore, EPA has determined that GACT should
be based on the use of oxidation catalysts for existing stationary
non-emergency CI engines greater than 300 HP and less than or equal to
500 HP that are located at area sources.  For existing stationary
non-emergency CI engines greater than 300 HP and less than or equal to
500 HP located at area sources, GACT for HAP emissions was therefore
determined to be 49 parts per million by volume dry basis (ppmvd) at 15
percent O2 or the reduction of CO by 70 percent.

In addition, in order to provide further reduction in metallic HAP
emissions from non-emergency engines between 300 HP and 500 HP at area
sources, EPA believes GACT should include the same requirements for
further reduction in crankcase emissions as was required for such
engines at major sources.  The rationale for promulgating such
requirements for such engines at major sources is found in the preamble
and Response to Comments document for this rule and in the memorandum
titled “MACT Floor Determination for Existing Stationary Non-Emergency
CI RICE Greater Than or Equal 100 HP Located at Major Sources,” which
is available in the rulemaking docket (EPA-HQ-OAR-2008-0708).

Therefore, GACT for non-emergency CI engines between 300 HP and 500 HP
that are located at area sources includes the following requirement: 1)
install a closed crankcase ventilation system that prevents crankcase
emissions from being emitted to the atmosphere, or 2) install an open
crankcase filtration emission control system that reduces the crankcase
emissions by filtering the exhaust stream to remove oil mist,
particulates, and metals.

Non-Emergency CI >500 HP

For stationary non-emergency CI engines greater than 500 HP, EPA
believes that oxidation catalyst technology is readily available and
feasible for all existing stationary non-emergency CI engines above 500
HP generally regardless of location.  Further, EPA has determined that
costs associated with implementing HAP-reducing technologies are
reasonable and justified.  In addition, it is estimated that the
benefits per ton are between $330,000 (Pope, 7%) and $790,000 (Laden,
7%) for PM for existing stationary CI engines at area sources.  The
benefits per ton outweigh the costs.  Further information on the
monetized benefits and the specific add-on control costs and cost per
ton estimates can be found in the memorandum “Cost per Ton of HAP
Reduced for Existing Stationary CI RICE,” available from the docket as
(EPA-HQ-OAR-2008-0708).  Therefore, EPA has determined that GACT should
be based on the use of oxidation catalysts for existing stationary
non-emergency CI engines greater than 500 HP that are located at area
sources.   Therefore, for existing stationary non-emergency CI engines
greater than 500 HP located at area sources, GACT for HAP emissions is
23 ppmvd of CO at 15 percent O2 or the reduction of CO by 70 percent.

Again, in order to provide further reduction in metallic HAP emissions
from non-emergency engines greater than 500 HP, EPA believes GACT should
include the same requirements for further reduction in crankcase
emissions as was required for such engines at major sources.  Therefore,
GACT for non-emergency CI engines greater than 500 HP that are located
at area sources includes the following: 1) install a closed crankcase
ventilation system that prevents crankcase emissions from being emitted
to the atmosphere, or 2) install an open crankcase filtration emission
control system that reduces the crankcase emissions by filtering the
exhaust stream to remove oil mist, particulates, and metals.

CI Engines Located in Rural Areas of Alaska not accessible by FAHS

For CI engines less than or equal to 300 HP located in remote areas of
Alaska, EPA has determined that GACT is management practices.  However,
GACT for other existing stationary non-emergency CI engines greater than
300 HP located at area sources is based on the use of add-on controls
and requires either compliance with a concentration or a percent
reduction standard.  Non-emergency CI engines greater than 300 HP that
are located in area of Alaska not accessible by the Federal Air Highway
System (FAHS), due to issues related to fuel availability and cost,
location of sources, and colder weather conditions, to name a few, face
unique challenges.  Therefore, EPA believes it is not appropriate to set
the same standards as for non-emergency CI engines greater than 300 HP
at other area sources.  Therefore, GACT for non-emergency CI engines
greater than 300 HP that are located in area of Alaska not accessible by
FAHS is management practices as follows:

changing the oil and oil filter every 1,000 hours of operation or
annually, whichever comes first, with an option to use an oil analysis
program as discussed above;

inspecting the air cleaner every 1,000 hours of operation or annually,
whichever comes first; and

inspecting all hoses and belts and replacing as necessary every 500
hours of operation or annually, whichever comes first.

Appendix A

Existing Stationary CI Engine Test Data Summary	Test Date	Engine Number
Engine Size (HP)	Test Method Used	CO Concentration (ppmvd @ 15% O2)
Comments

Test Facility

	Average 	Run 1	Run 2	Run 3

	Santa Barbara County Air Pollution Control District	1/22/2009	East
Crane 3	160	CARB 100	479.8	496.4	497.5	445.4

Santa Barbara County Air Pollution Control District	1/22/2009	West Crane
1	160	CARB 100	222.9	221.3	217.5	229.9

Santa Barbara County Air Pollution Control District	1/20/2009	East Crane
1	450	CARB 100	129.6	124.2	127.5	137.2

Santa Barbara County Air Pollution Control District	1/21/2009	East Crane
2	450	CARB 100	154.4	140.3	160.2	162.7

Precision Power	7/27/2005	Engine 1	550	EPA Method 10	45.6	46.6	45.0	45.1
100% load

Precision Power	7/29/2005	Engine 2	550	EPA Method 10	90.9	93.5	90.4	88.8
25% load

Precision Power	7/29/2005	Engine 2	550	EPA Method 10	57.7	56.6	58.8	57.5
50% load

Precision Power	7/29/2005	Engine 2	550	EPA Method 10	41.6	42.5	41.0	41.4
75% load

Precision Power	7/27/2005	Engine 2	550	EPA Method 10	23.5	23.7	23.7	23.0
100% load

Precision Power	7/28/2005	Engine 3	550	EPA Method 10	82.8	62.0	93.5	92.9
25% load, Arctic fuel

Precision Power	7/28/2005	Engine 3	550	EPA Method 10	59.9	59.3	58.3	62.3
50% load, Arctic fuel

Precision Power	7/28/2005	Engine 3	550	EPA Method 10	39.5	40.8	39.7	37.8
75% load, Arctic fuel

Precision Power	7/28/2005	Engine 3	550	EPA Method 10	42.8	41.6	44.3	42.4
100% load, Arctic fuel

Precision Power	7/26/2005	Engine 3	550	EPA Method 10	42.3	41.9	43.7	41.2
100% load

Precision Power	7/26/2005	Engine 4	550	EPA Method 10	28.9	25.6	23.2	38.0
100% load

CSU-Engines & Energy Conversion Laboratory	9/2/1999	Caterpillar 3508
1000	EPA Method 10	76.8	76.8	 	 	70% load

CSU-Engines & Energy Conversion Laboratory	9/1/1999	Caterpillar 3508
1000	EPA Method 10	44.1	44.1	 	 	70% load

CSU-Engines & Energy Conversion Laboratory	8/31/1999	Caterpillar 3508
1000	EPA Method 10	43.5	43.5	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	8/31/1999	Caterpillar 3508
1000	EPA Method 10	41.6	41.6	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	9/1/1999	Caterpillar 3508
1000	EPA Method 10	42.7	42.7	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	8/31/1999	Caterpillar 3508
1000	EPA Method 10	45.2	45.2	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	8/31/1999	Caterpillar 3508
1000	EPA Method 10	44.1	44.1	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	9/1/1999	Caterpillar 3508
1000	EPA Method 10	41.6	41.6	 	 	100% load

CSU-Engines & Energy Conversion Laboratory	9/1/1999	Caterpillar 3508
1000	EPA Method 10	76.2	76.2	 	 	70% load

CSU-Engines & Energy Conversion Laboratory	8/31/1999	Caterpillar 3508
1000	EPA Method 10	39.8	39.8	 	 	100% load

Badami Development Facility	6/26/2003	Generator 2	1680	EPA Method 10
327.1	330.3	330.1	320.8	75% load

Badami Development Facility	6/26/2003	Generator 2	1680	EPA Method 10
265.4	267.2	263.7	265.1	100% load

Badami Development Facility	6/26/2003	Generator 2	1680	EPA Method 10
196.9	182	200	209	50% load

Badami Development Facility	6/25/2003	Generator 2	1680	EPA Method 10
77.7	77.8	74.9	80.3	25% load

Northstar Development Project - BP	7/8/2004	Engine 6	3570	EPA Method 10
69.4	69.2	69.2	69.9	Low load

Northstar Development Project - BP	7/8/2004	Engine 6	3570	EPA Method 10
54.9	55.8	54.2	54.6	High load

Northstar Development Project - BP	7/9/2004	Engine 6	3570	EPA Method 10
55.5	56.7	54.9	54.8	Mid load

Northstar Development Project - BP	7/9/2004	Engine 7	3570	EPA Method 10
142.9	142.9

	Mid load

Northstar Development Project - BP	7/9/2004	Engine 7	3570	EPA Method 10
131.1	126.5	132.1	134.8	High load

Northstar Development Project - BP	7/9/2004	Engine 7	3570	EPA Method 10
127.8	127.8	 	 	Low load

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Reasons for Proposed Rulemaking.  Airborne Toxic Control Measure for
Stationary Compression Ignition Engines.  Stationary Source Division,
Emissions Assessment Branch.  September 2003.

E C/R Incorporated	Providing Environmental Technical Support Since 1989

501 Eastowne Drive, Suite 325  (  Chapel Hill, North Carolina 27514

Telephone:<PHONE_NUMBER>  (  Fax:<PHONE_NUMBER>

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[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Page 29747]
[FR Doc No: 2012-12206]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Orbit E-Commerce, Inc., Orion Ethanol, Inc., Pacificnet, Inc.,
PainCare Holdings, Inc., Pay88, Inc., Rahaxi, Inc., and Raven Biofuels
International Corp.; Order of Suspension of Trading

May 16, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Orbit E-Commerce, Inc. because it has not filed any periodic reports
since the period ended April 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Orion Ethanol, Inc. because it has not filed any periodic reports since
the period ended September 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Pacificnet, Inc. because it has not filed any periodic reports since
the period ended April 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
PainCare Holdings, Inc. because it has not filed any periodic reports
since the period ended September 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Pay88, Inc. because it has not filed any periodic reports since the
period ended June 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Rahaxi, Inc. because it has not filed any periodic reports since the
period ended March 31, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Raven Biofuels International Corp. because it has not filed any
periodic reports since the period ended March 31, 2009.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EDT
on May 16, 2012, through 11:59 p.m. EDT on May 30, 2012.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2012-12206 Filed 5-16-12; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: October 20, 2006 (Volume 71, Number 203)]
[Rules and Regulations]
[Page 61906-61911]
[DOCID:fr20oc06-15]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0815; FRL-8098-8]

Novaluron; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for
residues of novaluron in or on sugarcane. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on sugarcane. This regulation establishes a
maximum permissible level for residues of novaluron in this food
commodity. The tolerance expires and is revoked on December 31, 2009.

DATES: This regulation is effective October 20, 2006. Objections and
requests for hearings must be received on or before December 19, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0815. All documents in the
docket are listed on the regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0815 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before December 19, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0815, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the
insecticide novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy) phenyl]-3-[2,6-diflurobenzoyl]urea, in or on
sugarcane, cane at 0.15 parts per million (ppm). This tolerance expires
and is revoked on December 31, 2009. EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section

408(e) of the FFDCA allows EPA to establish a tolerance or an exemption
from the requirement of a tolerance on its own initiative, i.e.,
without having received any petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Novaluron on Sugarcane and FFDCA
Tolerances

    The Applicant claims that sugarcane borer populations have recently
increased and predator arthropod populations have decreased because of
tidal surges as a result of Hurricanes Katrina and Rita in 2005.
Additionally, the applicant states that the sugarcane borer developed
resistance in some locations to the most commonly used insecticide,
because of repeated use. Thus the applicant claims that the registered
alternatives will not be adequate to provide control of the sugarcane
borer in sugarcane, such that significant economic losses will be
suffered. EPA has authorized under FIFRA section 18 the use of
novaluron on sugarcane for control of the sugarcane borer in Louisiana.
After having reviewed the submission, EPA concurs that emergency
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of novaluron in or on
sugarcane. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance
under section 408(l)(6) of the FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although this tolerance expires and is revoked on December 31, 2009,
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
sugarcane after that date will not be unlawful, provided the pesticide
is applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether novaluron
meets EPA's registration requirements for use on sugarcane or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of novaluron by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than Louisiana to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing FIFRA section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
novaluron, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
novaluron and to make a determination on aggregate exposure, consistent
with section 408(b)(2) of the FFDCA, for a time-limited tolerance for
residues of novaluron in or on sugarcane, cane at 0.15 parts per
million (ppm). EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Endpoints

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by novaluron as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2004/June/Day-02/p12316.htm
.

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for novaluron used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 2, 2004 (69 FR 31013) (FRL-
7359-2).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.598) for the residues of novaluron in or on the
following raw agricultural commodities: Apple, wet pomace at 8.0 ppm;
Brassica, head and stem, subgroup 5A at 0.50 ppm; cattle, fat at 11
ppm; cattle, kidney at 1.0 ppm; cattle, liver at 1.0 ppm; cattle, meat
at 0.60 ppm; cattle, meat byproducts, except liver and kidney at 0.60
ppm; cotton, gin byproducts at 30 ppm; cotton, undelinted seed at 0.60
ppm; eggs at 0.05 ppm; fruit, pome, group 11 at 2.0 ppm; goat, fat at
11 ppm; goat, kidney at 1.0 ppm; goat, liver at 1.0 ppm; goat, meat at
0.60 ppm; goat, meat byproducts except liver and kidney at 0.60 ppm;
hog, fat at 0.05 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at
0.01 ppm; horse, fat at 11 ppm; horse, kidney at 1.0 ppm; horse, liver
at 1.0 ppm; horse, meat at 0.60 ppm; horse, meat byproducts, except
liver and kidney at 0.60 ppm; milk at 1.0 ppm; milk, fat at 20 ppm;
poultry, fat at 0.40 ppm; poultry, meat at 0.03 ppm; poultry, meat
byproducts at 0.04 ppm; sheep, fat at 11 ppm; sheep, kidney at 1.0 ppm;
sheep, liver at 1.0 ppm; sheep, meat at 0.60 ppm; sheep, meat
byproducts, except liver and kidney at 0.60 ppm, and vegetables,
tuberous and corn, subgroup 1C at 0.05 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from novaluron in food as
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. No such effects were identified in the
toxicological studies for novaluron. Therefore, a quantitative acute
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: 100% crops treated for all commodities; average
field trial residues; empirical processing factors for apple juice
(translated to pear juice); and DEEM\TM\ (ver 7.76) default processing
factors for the remaining processed commodities. Furthermore,
anticipated residues (ARs) were calculated for meat and milk
commodities and the recommended tolerances were used for poultry
commodities (partially refined, Tier II analysis).
    iii. Cancer. A cancer dietary exposure assessment was not conducted
because novaluron is classified as ``not likely to be carcinogenic to
humans.''
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for novaluron in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of novaluron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov.oppefed1/models/water/index.htm.

    The Agency uses the First Index Reservoir Screening Tool (FIRST)
and the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/
EXAMS) to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model
is used to predict pesticide concentrations in shallow groundwater. For
a screening-level assessment for surface water EPA will generally use
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model
includes a percent crop area factor as an adjustment to account for the
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    The highest concentrations of novaluron residues in surface water
and groundwater are associated with the use on apple (0.96 lb active
ingredient/Acre, the highest registered/proposed use rate). The
novaluron application scenario associated with apples is higher than
the application scenario associated with sugarcane; therefore, the
apple data were used for modeling. In drinking water, EPA concluded
that the parent compound and degradates chlorophenyl urea, 1-[3-chloro-
4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea and
chloroaniline, 3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy)aniline are the residues of concern for risk
assessment purposes. (Tier 2 PRZM/EXAMS) modeling was used to estimate
drinking water concentrations for surface water for novaluron per se.
The estimated drinking water concentration (EDWC: 1-in-10 year annual
mean) for novaluron per se is 1.8 micrograms/Liter ([mu]g/L) (parts per
billion (ppb)). For groundwater, the SCI-GROW model was used to predict
a groundwater concentration for novaluron. The EDWC for novaluron per
se is 5.5 x 10-3 [mu]g/L in drinking water from shallow
groundwater sources.
    A Tier I drinking water analysis was performed using the FQPA FIRST
model to obtain surface water estimates for the chlorophenyl urea and
chloroaniline degradates. For surface water, the annual average EDWC
for chlorophenyl urea is 0.86 [mu]g/L(ppb) and the annual average EDWC
for chloroaniline is 2.6 [mu]g/L(ppb). The SCI-GROW model was

used to predict groundwater concentrations. The predicted ground water
EDWC for chlorophenyl urea is 4.5 x 10-3 [mu]g/L, and for
chloroaniline the EDWC is 9.0 x 10-3 [mu]g/L. These EDWC
values are meant to represent upper-bound estimates of the
concentrations that might be found in surface water and groundwater
based upon novaluron uses. Of the EDWC values for the three different
compounds (novaluron per se, and its two degradates, chlorophenyl urea
and chloroaniline), the chronic estimate for chloroaniline is the
highest (100% conversion from parent to aniline was assumed). This is
consistent with the expected degradation pattern for novaluron, so the
EDWC value for chloroaniline (2.6 ppb) was used to assess chronic
aggregate risk, since it was the highest estimate derived and would
represent the most conservative exposure scenario. For chronic dietary
risk assessment, the annual average concentration of 2.6 ppb was
directly entered into the dietary exposure model (DEEM-FCID\TM\). Since
an acute dietary risk assessment was not needed, EECs of novaluron for
acute exposures to surface water and ground water were not used.
    3. Non-dietary exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Novaluron is not registered for use on any sites that would result
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to novaluron and any other
substances and novaluron does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that novaluron has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure to novaluron in developmental toxicity
studies. There is no quantitative or qualitative evidence of increased
susceptibility to novaluron following prenatal/postnatal exposure in a
2-generation reproduction study. EPA determined that the 10X SF to
protect infants and children should be reduced to 1X because of the
following reasons:
     There is no concern for developmental neurotoxicity
resulting from exposure to novaluron. A developmental neurotoxicity
study (DNT) study is not required.
     The toxicological database is complete for FQPA
assessment.
     Dietary assessments are estimated based on data that
reasonably accounts for potential exposures. The chronic dietary food
exposure assessment uses the conservative assumption that 100% of the
crops are treated for all commodities.
     The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
     There are no proposed or existing uses for novaluron which
result in residential exposure.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EDWCs. DWLOC values are not regulatory
standards for drinking water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food and residential uses. In calculating a
DWLOC, the Agency determines how much of the acceptable exposure (i.e.,
the PAD) is available for exposure through drinking water [e.g.,
allowable chronic water exposure (mg/kg/day) = cPAD - (average food +
chronic non-dietary, non-occupational exposure)]. This allowable
exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
    When EDWCs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to novaluron in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, OPP will reassess the potential impacts of
novaluron on drinking water as a part of the aggregate risk assessment
process.
    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surfacewater and groundwater EDWCs
are directly incorporated into the dietary exposure analysis, along
with food. This provides a more realistic estimate of exposure because
actual body weights and water

consumption from the CSFII are used. The combined food and water
exposures are then added to estimated exposure from residential sources
to calculate aggregate risks. The resulting exposure and risk estimates
are still considered to be high end, due to the assumptions used in
developing drinking water modeling inputs.
    1. Acute risk. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for novaluron; therefore,
novaluron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to novaluron
from food and drinking water contributions will utilize 20% of the cPAD
for the U.S. population, 72% of the cPAD for children 1 to 2 years old
and 34% of the cPAD for infants less than 1 year old. There are no
residential uses for novaluron that result in chronic residential
exposure to novaluron. Therefore, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD.
    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account residential exposure plus
chronic exposure to food and water (considered to be background
exposure levels.) Novaluron is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which were previously
addressed and do not exceed the Agency's levels of concern.
    4. Aggregate cancer risk for U.S. population. Novaluron is
classified as ``not likely to be carcinogenic to humans'' based on the
lack of evidence for carcinogenicity in mice and rats. Therefore,
novaluron is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, nor to infants and children from aggregate
exposure to novaluron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican
maximum residue limits for novaluron, so harmonization is not an issue.

VI. Conclusion

    Therefore, the tolerance is established for residues of novaluron,
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-
diflurobenzoyl]urea, in or on sugarcane, cane at 0.15 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.

Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.598 is amended by adding text to paragraph (b) to read
as follows:

Sec.  180.598  Novaluron; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the fungicide novaluron, 1-[3-chloro-4-
(1,1,2-trifluoro-2-trifluoromethoxyethoxy) phenyl]-3-[2,6-
diflurobenzoyl]urea in connection with use of the pesticide under a
section 18 emergency exemption granted by EPA. The tolerance will
expire and is revoked on the date specified in the following table:

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    revocation
                                                million        date
------------------------------------------------------------------------
Sugarcane, cane..............................       0.15        12/31/09
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-17566 Filed 10-19-06; 8:45 am]

BILLING CODE 6560-50-S