[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Rules and Regulations]
[Pages 9367-9373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4368]


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

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.

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

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#84f6e1f7ede0f1e1e9e1f0ecebe0f7c4e1f4e5aae3ebf2"><span class="__cf_email__" data-cfemail="2e5c4b5d474a5b4b434b5a46414a5d6e4b5e4f00494158">[email protected]</span></a>.

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:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Asparagus.............................................                                                       3.0
Coffee, bean..........................................                                                       0.1
Pepper, tabasco.......................................                                                       1.0
Rhubarb...............................................                                                       0.5
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-4368 Filed 3-3-09; 8:45 am]
BILLING CODE 6560-50-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>