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[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5696-5704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1779]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0980; FRL-8861-1]

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 multiple commodities which are identified 
and discussed later in this document. Syngenta Crop Protection, Inc., 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 2, 2011. Objections and 
requests for hearings must be received on or before April 4, 2011, 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-2009-0980. 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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 the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may 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 harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2009-0980 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be

[[Page 5697]]

received by the Hearing Clerk on or before April 4, 2011. Addresses for 
mail and hand delivery of objections and hearing requests are provided 
in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0980, 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. Summary of Petitioned-For Tolerances

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), 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 
9F7624) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.411 be amended by 
establishing tolerances for residues of the herbicide, fluazifop-P-
butyl, in or on banana and plantains at 0.01 parts per million (ppm); 
citrus (whole fruit), citrus (oil), and citrus (juice) at 0.05 ppm; 
citrus (dried pulp) at 0.40 ppm; grapes at 0.01 ppm; sugarbeet (root) 
at 0.25 ppm; sugarbeet (top) at 1.5 ppm; sugarbeet (dried pulp) at 1.0 
ppm; and sugarbeet (molasses) at 3.5 ppm.
    In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-
5), 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 
9E7651) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.411 be amended by 
establishing import tolerances for residues of fluazifop-P-butyl in or 
on potato, tuber at 1.1 ppm; potato, peel (wet) at 1.1 ppm; potato, 
chips at 3.0 ppm; and potato, granules/flakes at 5.0 ppm. That notice 
incorrectly identified fluazifop-P-butyl as an insecticide. A corrected 
notice, identifying fluazifop-P-butyl as an herbicide, was issued in 
the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-8).
    Those notices referenced summaries of the petitions prepared by 
Syngenta Crop Protection, Inc., the registrant, which are available in 
the dockets (PP9F7641, docket ID number EPA-HQ-OPP-2009-0833; and 
PP9E7651, docket ID number EPA-HQ-OPP-2009-0980), http://www.regulations.gov. There were no comments received in response to the 
notices of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerances for plantains, sugarbeet (top), 
and potato peel (wet) are unnecessary. EPA has also revised several of 
the proposed commodity terms and tolerances levels, as well as the 
proposed tolerance expression. The reasons for these changes are 
explained in Unit IV.C.

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 fluazifop-P-butyl 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
fluazifop-P-butyl 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 resolved, herbicidally-active isomer (R enantiomer) of 
fluazifop-butyl. The toxicity database for fluazifop-butyl is largely 
complete with sufficient toxicity data on fluazifop-P-butyl to 
demonstrate similar toxicity between the resolved and unresolved 
compounds.
    Fluazifop-P-butyl has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure. It is mildly irritating to the eye and 
skin and is not a skin sensitizer. In repeated-dose studies, the liver 
and kidney were the main target organs with toxicity expressed as liver 
toxicity in the presence of peroxisome proliferation and exacerbation 
of age-related kidney toxicity. The most sensitive endpoints were seen 
in the rat (decreased testes and epididymal weights in male rats and 
decreased pituitary and uterine weights in female rats), most likely 
due to the longer retention time of the major metabolite (fluazifop 
acid) in the rat. Fluazifop-P-butyl is classified as ``Not likely to be 
carcinogenic to humans,'' based on the lack of evidence of 
carcinogenicity in acceptable studies in rats and hamsters. The hamster 
was selected for cancer study, rather than the mouse, because liver 
peroxisome proliferation in hamsters more closely resembles what is 
found for human liver cells. There is no evidence that fluazifop butyl 
or fluazifop-P-butyl is mutagenic.
    There was no evidence of neurotoxicity or neuropathology in the 
available studies. 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; however, they were only 
seen at higher doses not considered relevant to human exposure.
    The toxicity database for fluazifop-butyl and fluazifop-P-butyl 
includes 7

[[Page 5698]]

developmental toxicity studies (5 in rats and 2 in rabbits) and a 2-
generation reproduction toxicity study in rats. Fetal effects 
(including delayed ossification, delayed development of the urinary 
tract, and diaphragmatic hernias) were consistent findings across the 
five rat developmental toxicity studies. Maternal toxicity in these 
studies was observed primarily as decreased weight/weight gain, with 
maternal effects occurring at higher doses (100/300 milligram/kilogram/
day (mg/kg/day)) than doses resulting in fetal effects (2.0/5.0 mg/kg/
day). In the rabbit developmental studies, developmental effects 
(nominal increases in delayed ossification, total litter loss, 
abortions, small fetuses, and cloudy eyes in one study; and an 
increased incidence of 13th rib and delayed ossification in sternebrae 
2 in the second study) occurred at doses also causing maternal toxicity 
(abortions, death, and weight loss). Similarly, in the reproduction 
toxicity study in rats, offspring effects (decreased viability in the 
F1 and F2 pups during lactational day 1, 4, 11, 
18, and 25; and decreased F2 pup weight on lactational day 
25) occurred at doses also resulting in parental toxicity (decreased 
spleen weight in males and increased absolute and relative liver and 
kidney weights and geriatric nephropathy in females). Reproductive 
toxicity was observed in this study as decreased absolute and relative 
testes and epididymal weight in males and, in females, decreased 
pituitary and uterine weights.
    For fluazifop, there were some indications of potential 
immunotoxicity in the form of thymic involution, altered spleen 
weights, lymphadenopathy and bone marrow myelogram changes in the 
chronic toxicity study in dogs. The significance of these effects is 
discussed in detail in Unit III.D.
    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 ``Revised Fluazifop-P-Butyl. 
Amended Human Health Risk Assessment to Support Use on Bananas, Citrus, 
Grapes, Sugar Beets, and the Establishment of a Tolerance on Imported 
Potatoes,'' pg. 60 in docket ID number EPA-HQ-OPP-2009-0980.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 shown in Table 1 of this Unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Fluazifop-P-Butyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                 Point of departure and      RfD, PAD, LOC for risk     Study and toxicological
      Exposure/scenario        uncertainty/safety factors          assessment                   effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13 to   NOAEL = 50 milligrams/      Acute RfD = 0.50 mg/kg/day  Developmental Toxicity in
 50 years of age).              kilograms/day (mg/kg/day)  aPAD = 0.50mg/kg/day......   Rats.
                                UFA = 10x.                                             Developmental LOAEL = 200
                               UFH = 10x.................                               mg/kg/day based on
                               FQPA SF = 1x..............                               diaphragmatic hernia.
                              ----------------------------------------------------------------------------------
Acute dietary (General          An appropriate endpoint attributable to a single dose was not identified in the
 population including infants           available studies, including the developmental toxicity studies.
 and children).
                              ----------------------------------------------------------------------------------
Chronic dietary (All           NOAEL= 0.74 mg/kg/day.....  Chronic RfD = 0.0074 mg/kg/ 2-generation Reproduction
 populations).                 UFA = 10x.................   day.                        in Rats.
                               UFH = 10x.................  cPAD = 0.0074 mg/kg/day...  LOAEL = 5.8 mg/kg/day in
                               FQPA SF = 1x..............                               males and 7.1 mg/kg/day
                                                                                        in females based on
                                                                                        decreased testes &
                                                                                        epididymal weights in
                                                                                        males, and uterine &
                                                                                        pituitary weights in
                                                                                        females.
Incidental oral short-term (1  NOAEL= 100 mg/kg/day......  LOC for MOE = 100.........  Developmental Toxicity in
 to 30 days).                   UFA = 10x................                               Rats.
                               UFH = 10x.................                              Maternal LOAEL = 300 mg/
                               FQPA SF = 1x..............                               kg/day based on maternal
                                                                                        body weight gain
                                                                                        decrement during GD 7-
                                                                                        16.
Incidental oral intermediate-  NOAEL= 0.74 mg/kg/day.....  LOC for MOE = 100.........  2-generation Reproduction
 term (1 to 6 months).          UFA= 10x.................                               in Rats.
                               UFH= 10x..................                              Parental/systemic LOAEL =
                               FQPA SF = 1x..............                               5.8 mg/kg/day in males
                                                                                        and 7.1 mg/kg/day in
                                                                                        females based on
                                                                                        decreased testes &
                                                                                        epididymal weights in
                                                                                        males, and uterine &
                                                                                        pituitary weights in
                                                                                        females.

[[Page 5699]]

 
Dermal short-term (1 to 30     Oral study NOAEL = 2.0 mg/  LOC for MOE = 100.........  Developmental Toxicity in
 days).                         kg/day (dermal absorption                               Rats.
                                rate = 9% at 2 mg dose                                 Developmental LOAEL = 5.0
                                and 2% at 200 mg dose.)                                 mg/kg/day based on fetal
                               UFA = 10x.................                               weight decrement,
                               UFH = 10x.................                               hydroureter, and delayed
                               FQPA SF = 1x..............                               ossification.
Dermal intermediate-term (1    Oral study NOAEL= 0.74 mg/  LOC for MOE = 100.........  2-generation Reproduction
 to 6 months) and long-term     kg/day (dermal absorption                               in Rats.
 (systemic LOAEL =
                                and 2% at 200 mg dose.)                                 5.8 mg/kg/day in males
                               UFA = 10x.................                               and 7.1 mg/kg/day in
                               UFH = 10x.................                               females based on
                               FQPA SF = 1x..............                               decreased testes &
                                                                                        epididymal weights in
                                                                                        males, and uterine &
                                                                                        pituitary weights in
                                                                                        females.
Inhalation short-term (1 to    Oral study NOAEL = 2.0 mg/  LOC for MOE = 100.........  Developmental Toxicity in
 30 days).                      kg/day (inhalation                                      Rats
                                absorption rate = 100%).                               Developmental LOAEL = 5.0
                               UFA = 10x.................                               mg/kg/day based on fetal
                               UFH = 10x.................                               weight decrement,
                               FQPA SF = 1x..............                               hydroureter, and delayed
                                                                                        ossification.
Intermediate-term (1 to 6      Oral study NOAEL = 0.74 mg/ LOC for MOE = 100.........  2-generation Reproduction
 months) and long-term (day (inhalation                                      in Rats.
 months).                       absorption rate = 100%).                               Parental/systemic LOAEL =
                               UFA = 10x.................                               5.8 mg/kg/day in males
                               UFH = 10x.................                               and 7.1 mg/kg/day in
                               FQPA SF = 1x..............                               females based on
                                                                                        decreased testes &
                                                                                        epididymal weights in
                                                                                        males, and uterine &
                                                                                        pituitary weights in
                                                                                        females.
                              ----------------------------------------------------------------------------------
Cancer (Oral, dermal,                               Not likely to be carcinogenic to humans.
 inhalation).
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

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. Such effects were identified 
for fluazifop-P-butyl for women of childbearing age (13 to 49 years 
old). In estimating acute dietary exposure, EPA used food consumption 
information from the U. S. Department of Agriculture (USDA) 1994-1996 
Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). 
As to residue levels in food, EPA assumed that all foods contain 
tolerance-level residues (adjusted to account for all metabolites of 
concern, based on the ratio of parent and metabolites found in plant 
metabolism studies) and that 100% of all crops are treated with 
fluazifop-P-butyl. Default processing factors were used to estimate 
residues in processed commodities.
    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 that residues 
were present either at tolerance or average field trial levels. As in 
the acute dietary exposure assessment, residue levels were adjusted to 
account for all metabolites of concern. Percent crop treated (PCT) data 
were used to refine exposure estimates for several currently registered 
crop uses; 100 PCT was assumed for all new crop commodities. Default 
processing factors were used to estimate residues in processed 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluazifop-P-butyl does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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 residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) 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. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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.

[[Page 5700]]

     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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    The Agency estimated the PCT for existing uses as follows: 
Asparagus 2.5%; carrot 10%; cherry 1%; cottonseed 2.5%; dry beans 1%; 
garlic 5%; onion (dry bulb) 15%; peach 2.5%; peanut 1%; pepper (non-
bell) 1%; and sweet potato 10%.
    In most cases, EPA uses available data from the U. S. 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 to7 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%.
    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 33.4 parts 
per billion (ppb) for surface water and 1.56 ppb for ground water. The 
EDWCs for chronic exposures for non-cancer assessments are estimated to 
be 6.6 ppb for surface water and 1.56 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 33.4 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 6.6 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: Turfgrass and broadleaf 
ornamentals. EPA assessed residential exposure using the following 
assumptions: Homeowners that apply fluazifop-P-butyl products may be 
exposed to fluazifop-P-butyl for short-term durations via the dermal 
and inhalation routes. There is also the potential for post-application 
exposure of adults and children from activities on treated turf areas, 
such as home lawns. Short-term dermal exposure of adults and children, 
as well as incidental oral (hand-to-mouth, object-to-mouth, and soil 
ingestion) exposure of children may occur. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 Web site 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 pre- and postnatal 
toxicity database for fluazifop/fluazifop-P-butyl includes five rat and 
two rabbit developmental toxicity studies as well as a 2-generation 
reproduction toxicity study in rats. As discussed in Unit III.A, there 
was evidence of quantitative susceptibility of fetuses to fluazifop-P-
butyl exposure in the rat developmental toxicity studies. The degree of 
concern for the increased susceptibility is low and there

[[Page 5701]]

is no residual uncertainty based on the following considerations: The 
endpoint of concern (delayed ossifications) is considered to be a 
developmental delay as opposed to a malformation or variation which 
would be considered to be more serious in nature; there were 
considerable variations in the incidences among the five rat studies; 
the NOAELs/LOAELs for this effect were well defined and consistent 
across these studies; and a developmental endpoint of concern 
(diaphragmatic hernia) is used for assessing acute dietary risk. Also, 
there was no evidence (quantitative or qualitative) of increased 
susceptibility of fetuses or offspring in the rabbit developmental 
studies or in the 2-generation rat reproduction toxicity study.
    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 adequate to 
assess pre- and postnatal toxicity, lacking only acute and sub-chronic 
neurotoxicity studies and immunotoxicity testing. Ninety-day dermal and 
inhalation toxicity studies are also required to confirm the PODs 
selected for assessing dermal and inhalation exposures based on route-
to-route extrapolations from oral studies. EPA does not believe an 
additional uncertainty factor is needed to account for the lack of 
these studies for the following reasons:
    a. Ninety-day dermal and inhalation studies. Fluazifop-P-butyl is 
expected to show similar toxicity by the inhalation and oral routes 
because of its metabolism by blood into the acid form and excretion in 
this manner. Further, EPA selected a conservative (protective) POD from 
a developmental toxicity study (NOAEL of 2.0 mg/kg/day) to assess both 
short-term dermal and inhalation exposures. The NOAEL from the 
available 28-day dermal study is considerably higher (100 mg/kg/day).
    Although a POD from an oral study was used to assess residential 
handler inhalation risks for fluazifop-P-butyl, EPA does not believe 
this aggregate risk assessment is under-protective of adult handlers. 
Handler MOEs based on the extrapolated endpoint are quite high (14,000 
to 1.1 million), and the contribution of residential exposure to 
aggregate risk is small. Therefore, even if an inhalation study were to 
provide a lower POD than the oral study, it's not expected to have a 
significant impact on aggregate risk.
    b. Neurotoxicity. There was no evidence of neurotoxicity or 
neuropathology in the available studies. 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; however, 
they were only seen at higher doses not considered relevant to human 
exposure.
    c. Immunotoxicity. There were some indications of potential 
immunotoxicity in the form of thymic involution, altered spleen 
weights, lymphadenopathy and bone marrow myelogram changes in the 
chronic toxicity study in dogs. EPA's concern for these effects is low, 
based on the following considerations: Thymic involution was of slight 
severity in only 1 female treated with the mid-dose; the response was 
equivocal in the males, as there was no dose-response relationship 
(incidence and severity) and controls also exhibited thymic involution. 
One control dog had severe thymic involution; the statistical and 
biological significance of the alterations in spleen weights could not 
be assessed because of the large variation in the weights of control 
dogs. Also, the alterations were inconsistent between dogs that died 
(these dogs displayed increased adrenal weights) and dogs that survived 
(these dogs displayed decreased adrenal weights); lymphadenopathy was 
observed only at the high dose (125 mg/kg/day) and the response is 
questionable, since the colony of dogs used in the study had excessive 
health problems that included lymphadenopathy; the bone marrow 
myelogram changes were small and variable and not considered dose-
related; and none of the potential immunological signs in the dog were 
seen in the rat, the most sensitive species. For these reasons, EPA 
considered the results of the chronic dog study to be unreliable. The 
colony of dogs used in the study had excessive health problems that may 
have impacted normal immune status, so that apparent immunotoxic 
effects were observed even in some untreated control animals. Moreover, 
no immunotoxic effects were observed in the sub-chronic dog study, a 
study where healthy animals were used. EPA therefore concludes that the 
available data do not warrant an additional uncertainty factor (UF) to 
account for the lack of an immunotoxicity study.
    ii. As noted previously in this unit, there is no indication that 
fluazifop-P-butyl is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. Although there is evidence of increased quantitative 
susceptibility in in utero rats in the prenatal developmental studies, 
the degree of concern for developmental effects is low, and EPA did not 
identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs to be used in the risk assessment of 
fluazifop-P-butyl.
    iv. There are no significant residual uncertainties identified in 
the exposure databases. A citrus processing study and data on the 
stability of fluazifop-P-butyl in processed potato commodities are 
required; however, EPA does not expect these data to have a measurable 
impact on exposure estimates for fluazifop-P-butyl. Data are available 
which demonstrate fluazifop-P-butyl is stable in a wide variety of 
frozen crop commodities, including potatoes. As such, EPA expects 
fluazifop to be stable in frozen potato processed commodities but is 
requiring data to confirm its stability in these fractions. The 
submitted citrus processing study was determined to be inadequate and 
EPA is, therefore, requiring that another study be conducted. In the 
interim, EPA is establishing tolerances for processed citrus 
commodities using worst-case concentration factors that will not 
underestimate residues of fluazifop-P-butyl in these commodities.
    The acute dietary food exposure assessment was performed based on 
tolerance-level residues and 100 PCT. The chronic assessment was 
refined for some commodities using reliable PCT information and 
anticipated residues values calculated from guideline field trial 
studies. 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 postapplication 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.

[[Page 5702]]

    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. 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 13% of the aPAD for females 13 to 49 
years old, the only population group for which an acute dietary 
endpoint of concern was identified.
    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 40% of the cPAD for 
children, 1 to 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 result in aggregate MOEs of 150 for adults 
and 250 for children. The MOE for adults includes chronic exposure from 
food and water plus short-term residential handler and post-application 
exposure of adult females (the adult population with the highest 
estimated exposure). The MOE for children includes chronic exposure 
from food and water plus combined dermal and incidental oral short-
term, post-application exposures. Because EPA's level of concern for 
fluazifop-P-butyl is a MOE of 100 or below, these MOEs are not 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). An intermediate-term adverse effect was identified; however, 
fluazifop-P-butyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for fluazifop-P-butyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluazifop-P-butyl is not expected to pose a cancer risk to 
humans.
    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, or to infants and children from aggregate 
exposure to fluazifop-P-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid 
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to 
enforce the tolerance expression. The method is available in Pesticide 
Analytical Methods (PAM), Volume II or 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fluazifop-P-butyl.

C. Revisions to Petitioned-For Tolerances

    EPA has determined that the proposed tolerances for plantains, 
sugarbeet (top), and potato peel (wet) are unnecessary. Residues of 
fluazifop-P-butyl on plantains will be covered by the tolerance for 
banana (40 CFR 180.1); and tolerances are no longer required for 
sugarbeet tops, which were removed from the Table I (Significant 
Feedstuffs Derived from Agricultural Crops Fed to Beef, Dairy, Poultry, 
and Swine) of the residue chemistry guidelines (860.1000 OPPTS 
Harmonized Test Guidelines) in June, 2008. A tolerance is not needed 
for potato peel, since processing data demonstrate that residues do not 
concentrate in the peel. Residues in the peel will, therefore, be 
covered by the tolerance for potato.
    EPA has also revised several of the proposed commodity terms and 
tolerances levels. Commodity terms were revised as follows to comply 
with the Agency's Food and Feed Vocabulary: ``Citrus (whole fruit),'' 
``grapes,'' ``potato tuber,'' ``sugarbeet (roots),'' ``sugarbeet (dried 
pulp),'' and ``sugarbeet (molasses)'' were revised to read ``fruit, 
citrus, group 10;'' ``grape;'' ``potato;'' ``beet, sugar, roots;'' 
``beet, sugar, dried pulp;'' and ``beet, sugar, molasses;'' 
respectively.
    The proposed tolerance for citrus was reduced from 0.05 ppm to 0.03 
ppm, the limit of quantitation (LOQ) of the residue analytical method, 
since all field trial residues were below the LOQ. The citrus 
processing study was inadequate for determining appropriate tolerances 
in processed citrus commodities. Therefore, maximum theoretical 
concentration factors were used in conjunction with the citrus field 
trial results (all flakes at 4.0 ppm. Compliance 
with the tolerance levels is to be determined by measuring only the sum 
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, calculated as the stoichiometric 
equivalent of fluazifop, in or on the commodity.

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 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) (Pub. L. 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: January 18, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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 paragraph (a) introductory 
text and alphabetically adding the following commodities to the table 
in paragraph (a) and revising paragraph (c) the introductory text 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, including its metabolites and degradates, 
in or on the following commodities in the table. Compliance with the 
tolerance levels specified in the table below is to be determined by 
measuring only the sum 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, calculated as 
the stoichiometric equivalent of fluazifop, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Banana.....................................................         0.01
 
                                * * * * *
Beet, sugar, dried pulp....................................         1.0
Beet, sugar, molasses......................................         3.5
Beet, sugar, roots.........................................         0.25
 
                                * * * * *
Citrus, dried pulp.........................................         0.40
Citrus, juice..............................................         0.06
Citrus, oil................................................        30.0
 

[[Page 5704]]

 
                                * * * * *
Fruit, citrus, group 10....................................         0.03
 
                                * * * * *
Grape......................................................         0.01
 
                                * * * * *
Potato\1\..................................................         1.0
Potato, chips\1\...........................................         2.0
Potato, granules/flakes\1\.................................         4.0
 
                                * * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the herbicide 
fluazifop-P-butyl, including its metabolites and degradates, in or on 
the following commodities in the table. Compliance with the tolerance 
levels specified in the table below is to be determined by measuring 
only the sum 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, calculated as the stoichiometric 
equivalent of fluazifop, in or on the commodity.
* * * * *
[FR Doc. 2011-1779 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P
```