FR Doc E9-4368

[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Rules and Regulations]
[Page 9367-9373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0066; FRL-8401-1]

Fluazifop-P-butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluazifop-P-butyl in or on beans, dry, seed; peanut; peanut, meal and
soybean, seed. Syngenta Crop Protection, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and
requests for hearings must be received on or before May 4, 2009, 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-2008-0066. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. 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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: miller.joanne
@epa.gov.

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 those
engaged in the following activities:
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 to
provide 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

[[Page 9368]]

the person listed under FOR FURTHER INFORMATION CONTACT.

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

In addition to accessing electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR site
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2008-0066 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 as required by 40 CFR part 178
on or before May 4, 2009.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2008-0066, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7289) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.411 be amended by
establishing tolerances for residues of the herbicide fluazifop-P-
butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, in or on dry beans at 25 parts per
million (ppm); peanuts at 1.5 ppm; soybean at 2.5 ppm; soybean meal at
2.5 ppm; and soybean refined oil at 0.01 ppm. That notice referenced a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant, which is available to the public in the docket, http://
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the field trial data supporting the petition
and to harmonize with the Food and Feed Commodity Vocabulary at http://
www.epa.gov/opphed01/foodfeed/index.htm. EPA has amended the commodity
listing to read: Beans, dry, seed at 50 ppm; peanut at 1.5 ppm; peanut,
meal at 2.2 ppm; and soybean, seed at 2.5 ppm. EPA is also editorially
combining the tolerance sections and correcting the tolerance
expressions to delete references to the unresolved isomer fluazifop-
butyl that is no longer a registered pesticide under FIFRA. Background
information is provided in the docket associated fluazifop-P-butyl;
Tolerance Reassessment Decision. The Notice of Availability was
published in the Federal Register of October 21, 2005 (70 FR 61287)
(FRL-7726-2).

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of 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 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 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. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of 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 and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of fluazifop-P-butyl on beans, dry, seed;
peanut; peanut, meal; and soybean, seed at 50 ppm, 1.5 ppm, 2.2 ppm,
2.5 ppm, respectively. EPA's assessment of exposures and risks
associated with establishing tolerances follows.

A. Toxicological Profile

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.
In characterizing the toxicity of fluazifop-P-butyl, EPA considered
data on both fluazifop-P-butyl and fluazifop-butyl. Fluazifop-P-butyl
is the purified (R) enantiomer of the mixed isomeric (RS) fluazifop-
butyl product and the data show them to be toxicological equivalent.
Fluazifop-P-butyl has shows no indication of being an eye or skin
irritant in acute or 21-day dermal studies, and is not a skin
sensitizer. Fluazifop-P-butyl does show similar toxicity by both the
inhalation and oral routes because of its metabolization by blood into
the acid form and excretion in this manner. The liver and kidney have
demonstrated to be its target organs expressed for the most part as
liver toxicity in the presence of peroxasome proliferation and
exacerbation of age related kidney toxicity. In general, there were no
carcinogenicity concerns in any acceptable studies in the rat with
fluazifop-butyl or in the hamster for fluazifop-P-butyl. The hamster
was selected for cancer study because liver

[[Page 9369]]

peroxasome proliferation more closely resembled what was found for
human liver cells. There were no mutagenicity concerns evident for
fluazifop-butyl or fluazifop-P-butyl. There were no concerns for
neurotoxicity resulting from fluazifop-P-butyl which were evident at
relevant exposure levels. There was also no evidence of clinical signs
which would indicate neurotoxicity or neuropathology in the available
studies as well. Marginal increases in brain weights at termination
were observed in a sub-chronic toxicity study in rats, and in a
carcinogenicity study performed on hamsters, but only at higher doses.
In all, it was concluded that there is no concern for developmental
neurotoxicity resulting from exposure to fluazifop-butyl or fluazifop-
P-butyl.
Specific information on the studies received and the nature of the
adverse effects caused by fluazifop-p-butyl 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.regulations.gov in the document Fluazifop-P-Butyl. Amended Human
Health Risk Assessment to Support Use on Dry Beans, Peanuts, and the
Post-Bloom Application to Soybeans, page 11 in docket ID number EPA-HQ-
OPP-2008-0066.

B. Toxicological Endpoints

For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluazifop-P-butyl used
for human risk assessment is discussed at http://www.regulations.gov in
the document Fluazifop-P-Butyl. Amended Human Health Risk Assessment to
Support Use on Dry Beans, Peanuts, and the Post-Bloom Application to
Soybeans, page 11 in docket ID number EPA-HQ-OPP-2008-0066..

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazifop-P-butyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluazifop-P-butyl
tolerances in (40 CFR 180.411). EPA assessed dietary exposures from
fluazifop-P-butyl in food as follows:
i. Acute exposure. 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.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA assumed all
foods for which there are tolerances (current and proposed) were
treated (100% crop treated (PCT) assumption)) and contain tolerance-
level residues with ratio adjustments to account for additional
metabolites of concern. PCT and/or anticipated residues were not used
in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed average
residue levels observed in applicable field trials and PCT were used.
iii. Cancer. The Agency has determined that fluazifop-P-butyl is
``not likely to be a human carcinogen'' based on the lack of evidence
of carcinogenicity in rats and hamsters and no mutagenicity concerns.
Therefore, a quantitative exposure assessment to evaluate cancer risk
is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows: Almonds 100%, asparagus
1%, carrots 10%, nectarines 1%, onions 15%, peaches 1%, pistachios
100%, pomegranates 100%, soybeans 100%, and watermelons 100%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.

[[Page 9370]]

The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fluazifop-P-butyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluazifop-P-butyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of fluazifop-P-butyl. 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.
Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
fluazifop-P-butyl for acute exposures are estimated to be 23.9 parts
per billion (ppb) for surface water and 0.59 ppb for ground water. For
chronic exposures assessments are estimated to be 5.1 ppb for surface
water and 0.59 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 23.9 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.1 ppb was used to assess
the contribution to drinking water.
3. From 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).
Fluazifop-P-butyl is currently registered for the following uses
that could result in residential exposures: Lawns, walks, driveways,
and ornamental planting beds. EPA assessed residential exposure using
the following assumptions: Homeowners that apply fluazifop-P-butyl
products may become exposed for short-term durations via the dermal and
inhalation routes. Fluazifop-P-butyl can be used in a number of
residential areas which may be frequented by the general population
such as on home lawns. This provides the potential for short-term
dermal (adults and children) and incidental oral exposure (children)
following residential applications of fluazifop-P-butyl.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
EPA has not found fluazifop-P-butyl to share a common mechanism of
toxicity with any other substances, and fluazifop-P-butyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
fluazifop-P-butyl does not have 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 EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for fluazifop-P-butyl includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. There is some evidence of quantitative
susceptibility following oral and dermal exposures to rats. Following
in-utero exposures, developmental effects (characterized as delayed
ossification) were seen in the absence of maternal toxicity in two
strains of rats. There is no evidence (quantitative or qualitative) of
susceptibility following in-utero oral exposure in rabbits or in the 2-
generation reproduction toxicity study in rats. No evidence of
neurotoxicity was seen.
Although increased prenatal and postnatal quantitative
susceptibility was seen in rats, the Agency concluded that there is a
low degree of concern and no residual uncertainties for prenatal and/or
postnatal toxicity effects of fluazifop-P-butyl because:
i. The short-term dermal and inhalation endpoint of concern
(delayed ossification) is considered to be a developmental delay rather
than a malformation or variation.
ii. The developmental endpoint of concern (diaphragmatic hernia)
used for assessing acute dietary risk was only found in one of the five
developmental rat toxicity studies conducted.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for fluazifop-P-butyl is complete except
for a confirmatory immunotoxicity study. EPA began requiring functional
immunotoxicity testing of all food and non-food use pesticides on
December 26, 2007. Since this requirement went into effect well after
the tolerance petition was submitted, these studies are not yet
available for fluazifop-P-butyl. In the absence of specific
immunotoxicity studies, EPA has evaluated the available fluazifop-P-
butyl toxicity data to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
The slight immunotoxicity findings in the chronic dog study are
unreliable due to the fact the dogs were unhealthy and no immunotoxic
effects were noted in the subchronic dog study where the dogs

[[Page 9371]]

were healthy. No other potential immunotoxicity effects were evident in
the toxicity database for fluazifop-P-butyl. The liver and kidney are
the primary target organs and the most sensitive species is the rat
(due to longer retention time of the major metabolite in this species).
Based on these considerations, EPA does not believe that conducting a
special series 870.7800 immunotoxicity study will result in a point of
departure less than the NOAEL of 0.74 milligram/kilogram/day used in
calculating the cPAD for fluazifop-P-butyl; therefore, an additional
database uncertainty factor is not needed to account for potential
immunotoxicity.
ii. There is no indication that fluazifop-P-butyl is a neurotoxic
chemical at relevant exposure levels and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There are no residual uncertainties for prenatal and/or
postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessments were performed
based on reliable data on average residue levels observed in applicable
field trials and PCT. Chronic exposure will not be underestimated. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to fluazifop-P-butyl in drinking
water. EPA used similarly conservative assumptions to assess post
application exposure of children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by fluazifop-P-butyl.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluazifop-P-butyl will occupy 12.1% of the aPAD for (females 13-49
years old) the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazifop-P-butyl from food and water will utilize 74.9% of the cPAD
for (children 1-2 years old) the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluazifop-P-butyl is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Fluazifop-P-butyl is currently registered for uses that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to fluazifop-P-butyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate margins of
exposure (MOEs) of 150 for the general U.S. population, 150 for adult
females and 240 for children; all below EPA's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Fluazifop-P-butyl is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to fluazifop-P-butyl through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
5. 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 or to infants and children from aggregate
exposure to fluazifop-P-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography-mass
spectrometry) 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: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits

There are no Codex Maximum Residue Limits (MRLs) established for
fluazifop residues. Canada has established a 1 ppm tolerance for
fluazifop-butyl calculated as the acid in soybeans, and a Mexico MRL is
established for fluazifop-p-butyl in soya at 1 ppm. The proposed U.S.
tolerances cannot be harmonized with the Canadian or Mexican MRLs for
soybean, because higher residues were observed in the U.S. crop field
trials.

C. Response to Comments

Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing conducted on animals have absolutely no validity and are
cruel to the test animals. B. Sachau's comments contained no scientific
data or evidence to rebut the Agency's conclusion that there is a
reasonable certainty that no harm will result from aggregate exposure
to fluazifop-P-butyl, including all anticipated dietary exposures and
all other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions, 70 FR 1349-1354 (January 7, 2005); 69 FR 63083- 63096
(October 29, 2004).

V. Conclusion

Therefore, tolerances are established for residues of fluazifop-P-
butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on
beans, dry, seed; peanut; peanut, meal; and soybean, seed at 50 ppm,
1.5 ppm, 2.2 ppm, and 2.5 ppm, respectively.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory

[[Page 9372]]

Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: February 12, 2009.
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 180.411 is amended by revising the section heading and
paragraphs (a) and (c) to read as follows:

Sec. 180.411 Fluazifop-P-butyl; tolerances for residues.

(a) General. Tolerances are established for residues of the
herbicide, fluazifop-P-butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on
the following commodities:

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Beans, dry, seed...................................... 50
Carrot, roots......................................... 2.0
Cattle, fat........................................... 0.05
Cattle, meat.......................................... 0.05
Cattle, meat byproducts............................... 0.05
Cotton, oil........................................... 0.2
Cotton, undelinted seed............................... 0.1
Egg................................................... 0.05
Endive................................................ 6.0
Fruit, stone.......................................... 0.05
Goat, fat............................................. 0.05
Goat, meat............................................ 0.05
Goat, meat byproducts................................. 0.05
Hog, fat.............................................. 0.05
Hog, meat............................................. 0.05
Hog, meat byproducts.................................. 0.05
Horse, fat............................................ 0.05
Horse, meat........................................... 0.05
Horse, meat byproducts................................ 0.05
Milk.................................................. 0.05
Nut, macadamia........................................ 0.1
Onion, bulb........................................... 0.5
Peanut................................................ 1.5
Peanut, meal.......................................... 2.2
Pecans................................................ 0.05
Poultry, fat.......................................... 0.05
Poultry, meat......................................... 0.05

[[Page 9373]]

Poultry, meat byproducts.............................. 0.05
Sheep, fat............................................ 0.05
Sheep, meat........................................... 0.05
Sheep, meat byproducts................................ 0.05
Soybean, seed......................................... 2.5
Spinach............................................... 6.0
Sweet Potato, roots................................... 0.05
----------------------------------------------------------------------------------------------------------------

* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of the herbicide,
fluazifop-P-butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on
the following commodities:

* * * * *
[FR Doc. E9-4368 Filed 3-3-09; 8:45 am]

BILLING CODE 6560-50-S