### 5696 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

Commodity Parts per million

Bushberry subgroup 13B .......... 3 .0 Caneberry subgroup 13A ......... 10
Canistel ..................................... 1 .2 Canola, seed 1 .......................... 0 .03 Citrus, dried pulp ...................... 8 .0 Citrus, oil ................................... 340 Fruit, pome ............................... 1 .7 Fruit, stone ................................ 2 .0 Grape ........................................ 2 .0 Grape, raisin ............................. 3 .0Herb subgroup 19A, dried, except parsley ........................... 15 .0Herb subgroup 19A, fresh, except parsley ........................... 3 .0 Juneberry .................................. 3 .0
Kiwifruit ..................................... 1 .8Leafy greens subgroup 4A, except spinach 35 ..................... 30
Lemon ....................................... 0 .60
Lime .......................................... 0 .60 Lingonberry ............................... 3 .0 Longan ...................................... 2 .0 Lychee ...................................... 2 .0 Mango ....................................... 1 .2 Onion, bulb ............................... 0 .60 Onion, green ............................. 4 .0 Papaya ...................................... 1 .2 Parsley, dried leaves ................ 170 Parsley, leaves ......................... 35
Pistachio ................................... 0 .10
Pulasan ..................................... 2 .0
Rambutan ................................. 2 .0
Salal .......................................... 3 .0 Sapodilla ................................... 1 .2 Sapote, black ............................ 1 .2 Sapote, mamey ........................ 1 .2 Spanish lime ............................. 2 .0 Star apple ................................. 1 .2 Strawberry ................................ 5 .0

Tomatillo ................................... 0 .45
Tomato ...................................... 0 .45 Tomato, paste ........................... 1 .0 Turnip, greens .......................... 10 .0 Vegetable, cucurbit, group 9 .... 0 .70 Vegetable, leaves of root and

tuber, group 2 ....................... 10Vegetable, root, except sugarbeet, subgroup 1B 41 ........... 0 .75
Watercress ................................ 20

1 Import only.

(2) Tolerances are established for residues of the fungicide cyprodinil, including its metabolites and degradates, in the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of cyprodinil 4-cyclopropyl-6-methyl- N
phenyl-2-pyrimidinamine and free and conjugated CGA–304075 4-(4- cyclopropyl-6-methyl-pyrimidin-2- ylamino)-phenol, calculated as the stoichiometric equivalent of cyprodinil.

Commodity Parts per million

Cattle, meat byproducts ............. 0.02 Goat, meat byproducts ............... 0.02 Horse, meat byproducts ............. 0.02 Commodity Parts per million

Sheep, meat byproducts ............ 0.02

* * * * *

[FR Doc. 2011–2157 Filed 2–1–11; 8:45 am]

**BILLING CODE 6560–50–P**

**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.

**SUMMARY :**  This regulation establishestolerances for residues of fluazifop-Pbutyl 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


### 5697 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

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. Thatnotice incorrectly identified fluazifop-Pbutyl 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 fluazifopbutyl and fluazifop-P-butyl includes 7


### 5698 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

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 F 1 and F 2 pups during lactational day 1, 4, 11, 18, and 25; and decreased F 2 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-effectlevel (NOAEL) and the lowest-observedadverse-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—S UMMARY OF 

### TOXICOLOGICAL 

### D OSES AND 

### E NDPOINTS FOR 

### F LUAZIFOP 

### -P-B UTYL FOR 

### U SE IN 

### H UMAN 

### H EALTH 

### R ISK 

### A SSESSMENT

Exposure/scenario Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects

Acute dietary (Females 13 to

50 years of age). NOAEL = 50 milligrams/kilograms/ day (mg/kg/day) UF A = 10x.
UF H = 10x ........................................ FQPA SF = 1x ................................. Acute RfD = 0.50 mg/kg/day ........... aPAD = 0.50mg/kg/day ................... Developmental Toxicity in Rats. Developmental LOAEL = 200 mg/

kg/day based on diaphragmatic

hernia.

Acute dietary (General population including infants and children). An appropriate endpoint attributable to a single dose was not identified in the available studies, including the developmental toxicity studies.

Chronic dietary (All populations). NOAEL= 0.74 mg/kg/day .................

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. Chronic RfD = 0.0074 mg/kg/day .... cPAD = 0.0074 mg/kg/day .............. 2-generation Reproduction in Rats. LOAEL = 5.8 mg/kg/day in males

and 7.1 mg/kg/day in females

based on decreased testes & epididymal weights in males, anduterine & pituitary weights in females. Incidental oral short-term (1

to 30 days). NOAEL= 100 mg/kg/day ..................

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. LOC for MOE = 100 ........................ Developmental Toxicity in Rats. Maternal LOAEL = 300 mg/kg/day

based on maternal body weight gain decrement during GD 7–16.

Incidental oral intermediateterm (1 to 6 months). NOAEL= 0.74 mg/kg/day .................

UF A= 10x .........................................
UF H= 10x ......................................... FQPA SF = 1x ................................. LOC for MOE = 100 ........................ 2-generation Reproduction in Rats. Parental/systemic LOAEL = 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.


### 5699 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

TABLE 

### 1—S UMMARY OF 

### TOXICOLOGICAL 

### D OSES AND 

### E NDPOINTS FOR 

### F LUAZIFOP 

### -P-B UTYL FOR 

### U SE IN 

### H UMAN 

### H EALTH 

### R ISK 

### A SSESSMENT

### —Continued

Exposure/scenario Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects

Dermal short-term (1 to 30

days). Oral study NOAEL = 2.0 mg/kg/day (dermal absorption rate = 9% at 2 mg dose and 2% at 200 mg dose.)

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. LOC for MOE = 100 ........................ Developmental Toxicity in Rats. Developmental LOAEL = 5.0 mg/kg/

day based on fetal weight decrement, hydroureter, and delayed
ossification.

Dermal intermediate-term (1

to 6 months) and longterm (<6 months). Oral study NOAEL= 0.74 mg/kg/day (dermal absorption rate = 9% at 2 mg dose and 2% at 200 mg dose.)

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. LOC for MOE = 100 ........................ 2-generation Reproduction in Rats. Parental/systemic LOAEL = 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. Inhalation short-term (1 to 30

days). Oral study NOAEL = 2.0 mg/kg/day (inhalation absorption rate = 100%).

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. LOC for MOE = 100 ........................ Developmental Toxicity in Rats Developmental LOAEL = 5.0 mg/kg/

day based on fetal weight decrement, hydroureter, and delayed
ossification.

Intermediate-term (1 to 6

months) and long-term (<6 months). Oral study NOAEL = 0.74 mg/kg/ day (inhalation absorption rate = 100%).

UF A = 10x ........................................
UF H = 10x ........................................ FQPA SF = 1x ................................. LOC for MOE = 100 ........................ 2-generation Reproduction in Rats. Parental/systemic LOAEL = 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.

Cancer (Oral, dermal, inhalation). Not likely to be carcinogenic to humans.

UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short-term study for long-term risk assessment. UF DB = 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.


### 5700 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

• 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 nonoccupational, 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-Pbutyl 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-tomouth, 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 withany other substances, and fluazifop-Pbutyl 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


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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 fluazifopP-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 andinhalation exposures based on route-toroute 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 subchronic 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 doserelated; 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-Pbutyl 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 impacton exposure estimates for fluazifop-Pbutyl. 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 notunderestimate residues of fluazifop-Pbutyl 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.


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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 concludedthat chronic exposure to fluazifop-Pbutyl 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. BecauseEPA’s level of concern for fluazifop-Pbutyl 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 intermediateterm 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 childrenfrom aggregate exposure to fluazifop-Pbutyl 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; email 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 fluazifopP-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 <0.03 ppm) to derive tolerances for citrus oil and juice (proposed at 0.05 ppm) of 30.0 ppm and 0.06 ppm, respectively. A maximum
theoretical concentration factor is not available for citrus pulp; however, a recent analysis of data for 27 different pesticides showed concentration of residues in citrus pulp of between 2x and 13x. EPA, therefore, used a
concentration factor of 13x in conjunction with field trial results to derive an appropriate tolerance of 0.40 ppm for citrus pulp, the same level proposed by the petitioner.

Finally, EPA is revising the requestedtolerance expression for fluazifop-Pbutyl in accordance with current Agency guidance. EPA is also makingthis change for the existing fluazifop-Pbutyl tolerances. The revised tolerance expression makes clear that the
tolerances cover residues of the


### 5703 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

herbicide fluazifop-P-butyl, including its metabolites and degradates, but that 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. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

V. Conclusion

Therefore, tolerances are established for residues of fluazifop-P-butyl, including its metabolites and degradates, in or on banana at 0.01 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, molasses at 3.5 ppm; beet, sugar, roots at 0.25 ppm; citrus, dried pulp at 0.40 ppm; citrus, juice at 0.06 ppm; citrus, oil at 30.0 ppm; fruit, citrus, group 10 at 0.03 ppm; grape at 0.01 ppm; potato at 1.0 ppm; potato, chips at 2.0 ppm; and potato, granules/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]**

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

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

■ 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:

**§ 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.

Commodity Parts per 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


### 5704 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

Commodity Parts per million

* * * * * 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 bymeasuring only the sum of fluazifop-Pbutyl, 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**

**ENVIRONMENTAL PROTECTION**
**AGENCY**

**40 CFR Part 180**

**[EPA–HQ–OPP–2008–0125; FRL–8860–1]**

**Sulfentrazone; Pesticide Tolerances**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  This regulation establishes
tolerances for residues of sulfentrazone in or on multiple commodities. Additionally, this regulation deletes existing tolerances on commodities superseded by the establishment of crop subgroups. This regulation also deletes a time-limited tolerance on bean, succulent seed without pod (lima bean and cowpea), as the tolerance expired on December 31, 2007. Interregional Research Project Number 4 (IR–4) 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–2008–0125. 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 :**  Laura Nollen, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7390; e-mail address: nollen.laura@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.

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–2008–0125 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 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–2008–0125, 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).