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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superseded by the establishment of crop 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). 


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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 March 12, 

2008 (73 FR 13225) (FRL–3854–6), 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 7E7308) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.498 be 

amended by establishing tolerances for 

residues of the combined free and 

conjugated residues of the herbicide 

sulfentrazone, [N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide] and its 

metabolites HMS [N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide] and 

DMS [(N-2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide] in or on 

food commodities Brassica, head and 

stem, subgroup 5A at 0.20 parts per 

million (ppm); Brassica, leafy greens, 

subgroup 5B at 0.35 ppm; melon, 

subgroup 9A at 0.10 ppm; vegetable, 

fruiting, group 8 at 0.05 ppm; okra at 

0.05 ppm; pea, succulent at 0.05 ppm; 

flax at 0.05 ppm; strawberry at 0.05 

ppm; and vegetable, tuberous and corn, 

subgroup 1C at 0.15 ppm. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 by FMC 

Corporation, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for several 

commodities. Additionally, the EPA has 

assessed several additional fruiting 

vegetable commodities in order to 

establish the revised and expanded 

fruiting vegetable group 8–10. EPA has 

also revised the tolerance expression for 

all established commodities to be 

consistent with current Agency policy. 

The reasons for these changes are 

explained in Unit IV.D. 

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 sulfentrazone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sulfentrazone 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. 

Sulfentrazone has low acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure. It is a mild eye 

irritant, but not a dermal irritant or 

sensitizer. Subchronic and chronic 

toxicity studies in rats, mice and dogs 

identified the hematopoietic system as 

the target of sulfentrazone. 

Protoporphyrinogen oxidase inhibition 

in the mammalian species may result in 

disruption of heme synthesis. In these 

studies, disruption of heme synthesis 

was observed at about the same dose 

levels across species except in the case 

of mice, where the effects were seen at 

a slightly higher dose. The 

hematotoxicity occurred around the 

same dose level for short- through longterm exposure without increasing in 

severity. 

In the oral and dermal rat 

developmental toxicity studies, 

decreased fetal body weights and 

reduced/delayed skeletal ossifications 

were noted at doses that were not 

maternally toxic. In rabbits, 

developmental effects such as decreased 

pup viability were observed at a 

maternally toxic dose (clinical signs, 

abortions and decreased body weight 

gains). In the 2-generation reproduction 

study in rats, offspring effects such as 

decreased body weights and decreased 

litter survival were observed at a 

maternally toxic dose (slightly 

decreased body weight gain). 

In the acute neurotoxicity study, an 

increased incidence of clinical signs 

(staggered gait, splayed hind limbs, and 

abdominal gripping), changes in 

functional observation battery (FOB) 

parameters, and decreased motor 

activity were observed; however, 

complete recovery was observed within 

14 days and there was no evidence of 

neuropathology. In the subchronic 

neurotoxicity study, clinical signs of 

toxicity, increased motor activity, and/ 

or decreased body weights, body weight 

gain, and food consumption were 

observed. There was no evidence of 

neuropathology in either study. In a 

published, non-guideline 

developmental toxicity study in the rat 

(de Castro, et al., 2007), several dosedependent effects (delayed ear opening, 

decreased grip response and rearing 

frequency, and increased surface 

righting reflex reaction time) were 

reported in pups whose mothers were 

treated with sulfentrazone. However, 

this study had several shortcomings that 

limit its use for regulatory purposes. 

Carcinogenicity studies in rats and 

mice showed no evidence of increased 

incidence of tumor formation due to 

treatment with sulfentrazone. Therefore, 

the EPA classified sulfentrazone as ‘‘not 

likely to be carcinogenic to humans.’’ 

The available mutagenicity studies 

indicate that sulfentrazone is weakly 

clastogenic in the in vitro mouse 

lymphoma assay in the absence of S9 

activation; however, the response was 

not evident in the presence of S9 

activation. Sulfentrazone is neither 

mutagenic in bacterial cells, nor 

clastogenic in male or female mice in 

vivo. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by sulfentrazone as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Sulfentrazone; REVISED Section 3 

Registration Request to Add New Uses 

on: Brassica, Head and Stem, Subgroup 

5A; Brassica, Leafy Greens, Subgroup 

5B; Melon, Subgroup 9A; Fruiting 


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Vegetable, Group 8 and Okra; Pea, 

Succulent; Flax; Strawberry; and 

Tuberous and Corm Vegetable, 

Subgroup 1C. Human-Health Risk 

Assessment.’’ pp. 51–56 in docket ID 

number EPA–HQ–OPP–2008–0125. 

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 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) (a = 

acute, c = chronic) 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. 

The doses and toxicological endpoints 

selected for several exposure scenarios 

including the acute dietary endpoints 

for females 13–49 years old, the chronic 

dietary endpoint, and the short- and 

intermediate-term inhalation endpoint 

have been revised since the last risk 

assessment based on a re-evaluation of 

the toxicology database. The updated 

endpoints are protective of 

sulfentrazone’s developmental toxicity, 

which was the critical effect in the 

database and observed via both the oral 

and dermal routes of exposure. 

The acute dietary endpoint is based 

on increased gestation duration, 

reduced prenatal viability (fetal and 

litter), reduced litter size, increased 

number of stillborn pups, reduced 

postnatal survival (pups and litter), and 

pup body weight deficits throughout 

lactation in both generations of offspring 

observed in a 2-generation reproductive 

toxicity study in rats. The 

developmental effects were reported in 

the presence of mild maternal toxicity 

(slightly decreased body-weight gain, 

particularly in F1 females). It has been 

EPA’s practice to consider various forms 

of developmental toxicity such as 

reduced prenatal viability, reduced litter 

size, and increased number of stillborn 

pups as single-dose effects and, 

therefore, relevant for the acute dietary 

(females aged 13–49) exposure scenario, 

in order to protect against potential 

exposure of pregnant females. It should 

be noted that the fetal body weight 

deficits and retardation in skeletal 

development (including decreased 

numbers of caudal vertebral and 

metacarpal ossification sites) reported in 

the oral rat prenatal developmental 

toxicity study were also evaluated for 

this acute dietary endpoint. However, it 

was concluded that such effects are 

unlikely due to a single dose event and 

are more appropriate for a repeatedexposure scenario. Furthermore, EPA 

has not traditionally considered delays 

in ossification (and related fetal body 

weight deficits) to be single dose effects. 

The chronic dietary endpoint is based 

on developmental toxicity (decreased 

fetal weights and delay in skeletal 

ossification) that was observed in the 

oral developmental toxicity study in the 

rat. This study provides the lowest 

NOAEL in the database, and the effects 

are similar to those observed in 

offspring (decreased body weight) at a 

slightly higher dose in the 2-generation 

reproduction study in rats. In addition, 

choice of the developmental toxicity 

study in the rat protects against 

exposure of women throughout their 

entire lifespan, which includes their 

childbearing years. 

The short- and intermediate-term 

inhalation endpoints are based on 

developmental toxicity (decreased fetal 

weights, delay in skeletal ossification) 

that was observed in the oral 

developmental toxicity study in the rat. 

An oral study was chosen for this 

exposure scenario in the absence of an 

inhalation toxicity study. Assuming 

100% absorption via the inhalation 

route, the oral developmental toxicity 

study protects pregnant women who 

might be exposed via inhalation against 

the critical effect observed in the 

sulfentrazone database, developmental 

toxicity. 

The endpoints for the other exposure 

scenarios remain the same. A summary 

of the toxicological endpoints for 

sulfentrazone used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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 13–49 

years of age).

NOAEL = 14 milligrams/kilogram/ 

day (mg/kg/day).

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

UFH = 10x .............

FQPA SF = 1x ......

Acute RfD = 0.14 

mg/kg/day.

aPAD = 0.14 mg/ 

kg/day.

2-Generation Reproductive Toxicity Study—Rat, Offspring Toxicity LOAEL= 

33 (M) and 40 (F) mg/kg/day based on reduced prenatal viability (fetal & litter), reduced litter size, increased number of stillborn pups, reduced pup 

and litter postnatal survival and decreased pup body weights throughout 

lactation. 

Acute dietary ...........

(General population 

including infants 

and children).

NOAEL = 250 mg/ 

kg/day.

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

UFH = 10x .............

FQPA SF = 1x ......

Acute RfD = 2.5 

mg/kg/day.

aPAD = 2.5 mg/kg/ 

day.

Acute-Neurotoxicity Study—Rat, LOAEL = 750 mg/kg/day based on increased 

incidence of clinical signs and FOB parameters and decreased motor activity. 

Chronic dietary (All 

populations).

NOAEL= 10 mg/kg/ 

day.

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

UFH = 10x .............

FQPA SF = 1x ......

Chronic RfD = 0.1 

mg/kg/day.

cPAD = 0.1 mg/kg/ 

day.

Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/ 

day, based upon decreased mean fetal weights, and retardation in skeletal 

development evidenced by an increased number of litters with any variation 

and by decreased number of caudal vertebral and metacarpal ossification 

sites. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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 

Incidental oral shortterm (1 to 30 

days) and intermediate-term (1 to 

6 months).

NOAEL= 14 mg/kg/ 

day.

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

UFH = 10x .............

FQPA SF = 1x ......

LOC for MOE = 

100.

2-Generation Reproduction Study—Rat, LOAEL = 33 mg/kg/day based on decreased pup body weights during lactation and reduced postnatal survival 

in both generations. 

Dermal short-term (1 

to 30 days) and 

intermediate-term.

(1 to 6 months) .......

Dermal (or oral) 

study NOAEL = 

100 mg/kg/day.

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

UFH = 10x .............

FQPA SF = 1x ......

LOC for MOE = 

100.

Dermal Developmental Study—Rat, LOAEL = 250 mg/kg/day based on decreased fetal body weight; increased incidences of fetal variations: hypoplastic or wavy ribs, incompletely ossified lumbar vertebral arches, and incompletely ossified ischia or pubes; and reduced number of thoracic 

vertebral and rib ossification sites. 

Inhalation short-term 

(1 to 30 days).

Inhalation (or oral) 

study NOAEL= 

10 mg/kg/day 

(inhalation absorption rate = 

100%).

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

UFH = 10x .............

FQPA SF = 1x ......

LOC for MOE = 

100.

Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/ 

day, based upon decreased mean fetal weights, and retardation in skeletal 

development evidenced by an increased number of litters with any variation 

and by decreased number of caudal vertebral and metacarpal ossification 

sites. 

Cancer (Oral, dermal, inhalation).Sulfentrazone is classified as ‘‘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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sulfentrazone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing sulfentrazone tolerances in 40 

CFR 180.498. EPA assessed dietary 

exposures from sulfentrazone 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 sulfentrazone. EPA performed 

separate acute risk assessments for 

females 13–49 years old and for the 

general population, including infants 

and children, based on different 

endpoints and aPADs. In estimating 

acute dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA used 

tolerance-level residues, Dietary 

Exposure Evaluation Model (DEEM)TM

(ver. 7.81) default processing factors, 

and assumed 100 percent crop treated 

(PCT) for all 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 

used tolerance-level residues, DEEMTM

(ver. 7.81) default processing factors, 

and assumed 100 PCT for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that sulfentrazone 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. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for sulfentrazone. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sulfentrazone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

sulfentrazone. 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. 

Sulfentrazone and 3-carboxylic acid 

sulfentrazone are the residues of 

concern in drinking water. Therefore, 

the First Index Reservoir Screening Tool 

(FIRST) model was used to estimate 

concentrations of sulfentrazone and 3- 

carboxylic acid sulfentrazone in surface 

water, and the Screening Concentration 

in Ground Water (SCI–GROW) model 

was utilized to estimate concentrations 

in ground water. The estimated drinking 

water concentrations (EDWCs) of 

sulfentrazone and 3-carbyoxylic acid 

sulfentrazone for acute exposures are 

estimated to be 35.8 parts per billion 

(ppb) for surface water and 26.0 ppb for 

ground water. For chronic exposures for 

non-cancer assessments, EDWCs are 

estimated to be 7.8 ppb for surface water 

and 26.0 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 35.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 26.0 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 


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flea and tick control on pets). 

Sulfentrazone is currently registered for 

the following use that could result in 

residential exposures: residential home 

lawns/turf and recreational turf, such as 

golf courses (application by professional 

applicators only). EPA assessed 

residential exposure using the following 

assumptions: Adults were assessed for 

potential short-term dermal and 

inhalation handler exposure from 

applying sulfentrazone to residential 

turf/home lawns and for short-term 

postapplication dermal exposure from 

contact with treated residential and 

recreational turf (home lawns and golf 

courses). Youths, ages 10–12 years old, 

were selected as a representative 

population to assess postapplication 

dermal exposure from contact with 

treated residential and recreational turf 

(home lawns and golf courses). 

Children, ages 3–6 years old, were 

selected as a representative population 

to assess for postapplication dermal and 

incidental oral (hand-to-mouth, objectto-mouth, soil ingestion and episodic 

ingestion of granules) exposure to 

residential turf/home lawns. As shortand intermediate-term points of 

departure are the same, the short-term 

assessment is considered protective of 

intermediate-term exposures. For 

children, however, while all three 

incidental oral exposures were 

aggregated for short-term exposures, the 

intermediate-term postapplication 

exposure scenario included only the soil 

ingestion incidental oral pathway, as 

this is the only pathway assumed to 

potentially result in intermediate-term 

exposures. Chronic exposures are not 

expected and were not assessed. 

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 sulfentrazone to 

share a common mechanism of toxicity 

with any other substances, and 

sulfentrazone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that sulfentrazone 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 (10×) 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 10×, 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. 

There is evidence of increased 

quantitative susceptibility following in 

utero exposure in the oral and dermal 

rat developmental toxicity studies. 

Developmental effects, including 

decreased fetal body weights and 

reduced/delayed skeletal ossifications 

were observed at doses that were not 

maternally toxic. In the 2-generation 

reproduction study in rats, offspring 

effects such as decreased body weights 

and decreased litter survival were 

observed at a slightly maternally toxic 

dose (slightly decreased body weight 

gain), indicating possible slightly 

increased qualitative susceptibility. 

Additionally, several dose-dependent 

effects were observed in rat pups whose 

mothers were treated with sulfentrazone 

in a published non-guideline rat 

developmental 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 

sulfentrazone is complete except for 

immunotoxicity testing. Recent changes 

to 40 CFR part 158 require 

immunotoxicity testing (OPPTS Test 

Guideline 870.7800) for pesticide 

registration. However, the existing data 

are sufficient for endpoint selection for 

exposure/risk assessment scenarios, and 

for evaluation of the requirements under 

the FQPA. The toxicology database for 

sulfentrazone does not show any 

evidence of treatment-related effects on 

the immune system; the overall weight 

of evidence is consistent with this 

chemical being a PPO inhibitor resulting 

in disruption of heme biosynthesis and 

subsequent effects on red blood cell 

dysfunction (e.g., anemia). Unlike white 

blood cells (leukocytes) which are cells 

of the immune system, red blood cells 

function to deliver oxygen to body 

tissues and are not involved in eliciting 

an immune response. Furthermore, 

there is no indication in the 

sulfentrazone database of any effect on 

leukocyte counts (an indicator of 

immune function). Thus, the overall 

weight of evidence indicates that this 

chemical does not directly target the 

immune system. Sulfentrazone also 

does not belong to a class of chemicals 

(e.g., the organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. Based on the above 

considerations, EPA does not believe 

that conducting a functional 

immunotoxicity study will result in a 

lower point of departure than that 

currently used for overall risk 

assessment. Therefore, an additional 

database UF to account for potential 

immunotoxicity does not need to be 

applied. 

ii. The toxicity database for 

sulfentrazone does not trigger the need 

for a developmental neurotoxicity 

(DNT) study. There are no indications in 

any of the studies available that the 

nervous system is a target for 

sulfentrazone. The FOB findings were 

very non-specific signs of toxicity 

(perianal staining, colored tears) and 

motor activity changes only occurred at 

higher doses following acute exposure 

with rapid reversibility, also indicating 

general toxicity rather than specific 

neurotoxicity. The lack of 

neuropathological findings further 

supports the non-specific nature of the 

signs observed. In addition, there is a 

literature DNT study available for 

sulfentrazone. The only reliable effects 

seen in this study involved effects on 

physical and reflex development, which 

are known to be affected by body 

weight. Therefore, these effects are 

likely secondary to the effects 

(including body weight deficits) 

reported in the 2-generation 

reproductive toxicity study. EPA 

employed an independent statistical 

method to evaluate the literature DNT in 

an effort to determine if these effects 

were consistent with effects observed in 

other guideline studies at these same 

dose levels. The results of that analysis 

indicate that the results of the literature 

DNT study are consistent with what was 

observed in the rat 2-generation 


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reproduction study and that the studies 

used for risk assessment (NOAEL of 10 

mg/kg/day from the developmental 

toxicity study in rat and the NOAEL of 

14 mg/kg/day from the 2–generation 

reproduction study), are protective of 

the observations made at ≥25 mg/kg/day 

in the literature study for which a 

NOAEL was not attained. Based on the 

weight of evidence, there is no 

uncertainty related to developmental 

neurotoxicity. 

iii. There is evidence of increased 

quantitative susceptibility following in 

utero exposure in the oral and dermal 

developmental toxicity studies in rats 

and possible evidence of slightly 

increased qualitative susceptibility of 

offspring in the 2-generation rat 

reproduction study. However, concern 

is low because clear NOAELs have been 

identified for the effects noted in these 

studies and both of the developmental 

toxicity studies have been chosen for 

endpoint selection, thereby protecting 

the relevant human subpopulations 

from the noted effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to sulfentrazone 

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 sulfentrazone. 

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 aPAD and 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. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

sulfentrazone will occupy <1% of the 

aPAD for the general population, 

including infants and children. For 

females 13–49 years old, the acute 

dietary exposure to sulfentrazone from 

food and water will occupy 2.3% of the 

applicable aPAD chosen for that 

population subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to sulfentrazone 

from food and water will utilize 3.6% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of sulfentrazone is not 

expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Sulfentrazone is 

currently registered for uses that could 

result in short- and intermediate-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short- and intermediateterm residential exposures to 

sulfentrazone. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate-term food, water, and 

residential exposures result in aggregate 

MOEs of 310 for the general U.S. 

population; 450 for children 1–2 years 

old for short-term exposures; and 590 

for children 1–2 years old for 

intermediate-term exposures. Because 

EPA’s level of concern for sulfentrazone 

is a MOE of 100 or below, these MOEs 

are not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

sulfentrazone is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

sulfentrazone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC)) is available 

to enforce the tolerance expression. The 

method has been forwarded for 

inclusion in the Pesticides Analytical 

Manual, Volume II. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail 

address: residuemethods@epa.gov. 

B. International Residue Limits 

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. 

There are no Codex, Canadian, or 

Mexican MRLs established for residues 

of sulfentrazone in or on the subject 

commodities. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that had an objection to 

‘‘the manufacture or sale’’ of 

sulfentrazone, citing the cruelty of 

animal testing as the main source of 

opposition. The Agency has received 

these same or similar comments from 

this commenter on numerous previous 

occasions. Please refer to the Federal 

Register of 70 FR 1349 (January 7, 2005) 

and 70 FR 37683 (June 30, 2005) for the 

Agency’s previous responses to these 

and other similar comments. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised the 

proposed tolerances for the following 

commodities: Brassica, leafy greens, 

subgroup 5B from 0.35 ppm to 0.40 

ppm; melon, subgroup 9A from 0.10 

ppm to 0.15 ppm; vegetable, fruiting, 

group 8 from 0.05 ppm to 0.15 ppm; 

okra from 0.05 ppm to 0.15 ppm; pea, 

succulent from 0.05 ppm to 0.15 ppm; 

flax from 0.05 ppm to 0.15 ppm; and 

strawberry from 0.05 ppm to 0.15 ppm. 

EPA revised the tolerance levels based 

on analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

Additionally, EPA was petitioned for 

tolerances on fruiting vegetable group 8 


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and a separate tolerance on okra. In the 

Federal Register of December 8, 2010 

(75 FR 76284) (FRL–8853–8), EPA 

issued a final rule that revised the crop 

grouping regulations. As part of this 

action, EPA expanded and revised the 

existing fruiting vegetable crop group 8. 

Changes to crop group 8 included 

adding okra, cocona, African eggplant, 

pea eggplant, scarlet eggplant, goji berry, 

garden huckleberry, martynia, 

naranjilla, roselle, sunberry, bush 

tomato, currant tomato, and tree tomato; 

creating subgroups; revising the 

representative commodities; and 

naming the new crop group fruiting 

vegetable group 8–10. EPA indicated in 

the December 8, 2010 final rule as well 

as the earlier January 6, 2010 proposed 

rule (75 FR 807) (FRL–8801–2) that, for 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. Therefore, 

consistent with this rule, EPA has 

assessed and is establishing a tolerance 

on fruiting vegetable group 8–10. 

Finally, the EPA has revised the 

tolerance expression to clarify (1) that, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of sulfentrazone not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the combined residues of 

free and conjugated forms of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, in or on 

Brassica, head and stem, subgroup 5A at 

0.20 ppm; Brassica, leafy greens, 

subgroup 5B at 0.40 ppm; melon, 

subgroup 9A at 0.15 ppm; vegetable, 

fruiting, group 8–10 at 0.15 ppm; pea, 

succulent at 0.15 ppm; flax at 0.15 ppm; 

strawberry at 0.15 ppm; and vegetable, 

tuberous and corm, subgroup 1C at 0.15 

ppm. Additionally, this regulation 

deletes existing individual tolerances in 

or on cabbage at 0.20 ppm and potato 

at 0.15 ppm, and further deletes the 

time-limited tolerance for bean, 

succulent seed without pod (lima bean 

and cowpea) at 0.1 ppm. 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 14, 2011. 

Daniel J. Rosenblatt, 

Acting 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 180.498 is amended as 

follows: 

■ i. Revise the introductory text of 

paragraph (a)(1); 

■ ii. Revise the introductory text of 

paragraph (a)(2), remove the entries for 

‘‘Cabbage’’ and ‘‘Potato’’ and add 

commodities to the table; 

■ iii. Revise paragraph (b); and 

■ iv. Revise the introductory text of 

paragraph (d), to read as follows: 

§ 180.498 Sulfentrazone; tolerances for 

residues. 

(a)(1) General. Tolerances are 

established for the combined residues of 

the free and conjugated forms of 

sulfentrazone, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 


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specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolite HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. 

* * * * * 

(2) Tolerances are established for the 

combined residues of the free and 

conjugated forms of sulfentrazone, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem, subgroup 5A ................................. 0.20 

Brassica, leafy greens, subgroup 

5B ............................................ 0.40 

* * * * * 

Flax ............................................. 0.15 

* * * * * 

Melon, subgroup 9A ................... 0.15 

Pea, succulent ............................ 0.15 

* * * * * 

Strawberry .................................. 0.15 

* * * * * 

Vegetable, fruiting, group 8–10 .. 0.15 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.15 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for the combined residues of the free 

and conjugated forms of sulfentrazone, 

including its metabolites and 

degradates, in connection with use of 

the pesticide under section 18 

emergency exemptions granted by EPA. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. These 

tolerances expire and are revoked on the 

dates specified in the following table. 

Commodity Parts per 

million 

Expiration/ 

revocation date 

Flax, seed .................................................................................................................................................... 0.20 12/31/13 

Strawberry .................................................................................................................................................... 0.60 12/31/13 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for 

inadvertent and indirect combined 

residues of the free and conjugated 

forms of sulfentrazone, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities when present 

therein as a result of the application of 

sulfentrazone to growing crops. 

* * * * * 

[FR Doc. 2011–1898 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0796; FRL–8860–2] 

Bispyribac-sodium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bispyribacsodium in or on fish, freshwater. Valent 

U.S.A. Corporation 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–2009–0796. 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. 


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