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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 .0 

Herb subgroup 19A, dried, except parsley ........................... 15 .0 

Herb subgroup 19A, fresh, except parsley ........................... 3 .0 

Juneberry .................................. 3 .0 

Kiwifruit ..................................... 1 .8 

Leafy 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 ....................... 10 

Vegetable, 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-Nphenyl-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 establishes 

tolerances 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 


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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-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 


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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-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—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZIFOP-P-BUTYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

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) UFA = 10x.

UFH = 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 .................

UFA = 10x ........................................

UFH = 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, and 

uterine & pituitary weights in females. 

Incidental oral short-term (1 

to 30 days).

NOAEL= 100 mg/kg/day ..................

UFA = 10x ........................................

UFH = 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 .................

UFA= 10x .........................................

UFH= 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. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZIFOP-P-BUTYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—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.) 

UFA = 10x ........................................

UFH = 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.) 

UFA = 10x ........................................

UFH = 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%).

UFA = 10x ........................................

UFH = 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%).

UFA = 10x ........................................

UFH = 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. 

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. 


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• 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 with 

any 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 and 

inhalation 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 impact 

on 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 not 

underestimate 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 concluded 

that 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. Because 

EPA’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 children 

from 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 requested 

tolerance expression for fluazifop-Pbutyl in accordance with current 

Agency guidance. EPA is also making 

this change for the existing fluazifop-Pbutyl tolerances. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 


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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 


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Commodity Parts per 

million 

* * * * * 

Fruit, citrus, group 10 ............... 0 .03 

* * * * * 

Grape ........................................ 0 .01 

* * * * * 

Potato1 ...................................... 1 .0 

Potato, chips1 ........................... 2 .0 

Potato, granules/flakes1 ............ 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-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). 


rmajette on DSK29S0YB1PROD with RULES