Document ID: EPA-HQ-OPP-2011-0758-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Sulfentrazone
Posted Date: 2012-07-12T04:00Z

[Federal Register Volume 77, Number 134 (Thursday, July 12, 2012)]
[Rules and Regulations]
[Pages 41081-41088]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17020]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0758; FRL-9353-8]

Sulfentrazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sulfentrazone in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) and FMC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 12, 2012. Objections and 
requests for hearings must be received on or before September 10, 2012, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0758 is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: ertman.andrew@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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2011-0758 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 
September 10, 2012. Addresses for mail and hand delivery of objections

[[Page 41082]]

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-2011-0758, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Do not submit electronically any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection 
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for 
hand delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 5, 2011 (76 FR 61647) (FRL-8890-
5), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7890) 
by (IR-4), Rutgers, The State University of New Jersey, 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 herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolites 3-
hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on rhubarb at 0.2 parts per 
million (ppm); turnip, roots at 0.2 ppm; turnip, tops at 0.7 ppm; and 
sunflower subgroup 20B at 0.2 ppm; ``Tolerances with regional 
registrations'' in or on wheat, forage at 0.45 ppm (Pacific Northwest 
only); wheat, hay at 0.20 ppm (Pacific Northwest only); wheat, grain at 
0.20 ppm (Pacific Northwest only); wheat, straw at 1.4 ppm (Pacific 
Northwest only); and cowpea, succulent at 0.15 ppm (Tennessee only). In 
addition, the petition requested to amend the current tolerances in 40 
CFR 180.498 in or on bean, lima, succulent at 0.15 ppm by removing the 
tolerance from the table in Section (a)(2) and adding the tolerance to 
Section (c) Tolerances with regional registrations. Upon approval of 
the aforementioned tolerance on the sunflower subgroup 20B, the 
petition additionally proposed to remove the established tolerance in 
or on the raw agricultural commodity sunflower, seed at 0.2 ppm. That 
notice referenced a summary of the petition prepared by FMC, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    In the Federal Register of July 6, 2011 (76 FR 39358) (FRL-8875-6), 
EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7838) 
by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The 
petition requested that 40 CFR 180.498 be amended by establishing 
tolerances for residues of the herbicide sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-
triazol-1-yl]phenyl]methanesulfonamide) and its metabolites 3-
hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on crop group 10-10 citrus fruit 
at 0.15 ppm; crop group 13-07 berry and small fruit at 0.15 ppm; crop 
group 14 tree nut and pistachio at 0.15 ppm; and crop group 18 non-
grass animal feed (forage, fodder, straw, and hay): Alfalfa, forage at 
5 ppm; alfalfa, hay at 20 ppm; alfalfa, seed at 3 ppm; clover, forage 
at 5 ppm; clover, hay at 20 ppm; and clover, seed at 3 ppm. That notice 
referenced a summary of the petition prepared by FMC, the registrant, 
which is available in the docket, http://www.regulations.gov. A comment 
was received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerance levels for some commodities and is not 
establishing tolerances on alfalfa forage, hay, and seed and clover 
forage, hay, and seed. 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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.
    Based on the results of acute toxicity studies in rats, 
sulfentrazone was classified as having low acute toxicity via the oral, 
dermal, and inhalation routes of exposure. It is a mild eye

[[Page 41083]]

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 long-term 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. A published, non-guideline 
developmental toxicity study in the rat (de Castro, et al., 2007) 
failed to demonstrate conclusively developmental neurotoxicity and 
contains several shortcomings that limit its use for regulatory 
purposes. Further, the reported offspring effects involving measures of 
physical and reflex development are likely secondary effects reflective 
of the poor general state of the offspring, as reported in the rat 2-
generation reproductive toxicity study at similar dose levels.
    No systemic toxicity was seen via the dermal route up to the limit 
dose in a 28-day dermal toxicity study in rabbits.
    Preliminary review of a recently submitted 28-day rat 
immunotoxicity study suggests that sulfentrazone does not directly 
target the immune system; and, there is no evidence of immunotoxicity 
in the rest of the toxicity database for sulfentrazone.
    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-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in the document titled 
``Sulfentrazone: Human-Health Risk Assessment for the Establishment of 
Sulfentrazone Tolerances in/on: Rhubarb, Turnip Roots and Tops, 
Sunflower Subgroup 20B, Succulent Cowpea, Succulent Lima Bean, 
Succulent Vegetable Soybean, Wheat (Spring), Citrus Fruit Group 10-10, 
Low-Growing Berry Group 13-07, Tree Nut Group 14, Pistachios, and Crop 
Group 18 Nongrass Animal Feeds,'' pp. 45-49 in docket ID number EPA-HQ-
OPP-2011-0758.

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 sulfentrazone used for 
human risk assessment is shown in the following table:

  Table--Summary of Toxicological Doses and Endpoints for Sulfentrazone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 14 mg/kg/day  Acute RfD = 0.14 mg/ 2-Generation Reproductive Toxicity
 years of age).                    UFA = 10X...........   kg/day               Study--Rat Offspring Toxicity
                                   UFH = 10X...........  aPAD = 0.14 mg/kg/    LOAEL = 33 (M) and 40 (F) mg/kg/
                                   FQPA SF = 1X........   day.                 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  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity Study--Rat
 including infants and children).   day                   kg/day               LOAEL = 750 mg/kg/day based on
                                   UFA = 10X...........  aPAD = 2.5 mg/kg/     increased incidence of clinical
                                   UFH = 10X...........   day.                 signs and FOB parameters and
                                   FQPA SF = 1X........                        decreased motor activity.

[[Page 41084]]

 
Chronic dietary (All populations)  NOAEL = 14 mg/kg/day  Chronic RfD = 0.14   2-Generation Reproductive Toxicity
                                   UFA = 10X...........   mg/kg/day            Study--Rat Offspring Toxicity
                                   UFH = 10X...........  cPAD = 0.14 mg/kg/    LOAEL = 33 (M) and 40 (F) mg/kg/
                                   FQPA SF = 1X........   day.                 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.
Short- (1-30 days) and             NOAEL = 14 mg/kg/day  LOC for MOE = 100    2-Generation Reproduction Study--
 Intermediate-Term (1-6 months)    UFA = 10X...........                        Rat Offspring LOAEL = 33 mg/kg/
 Incidental Oral.                  UFH = 10X...........                        day based on decreased pup body
                                   FQPA SF = 1X........                        weights and reduced postnatal
                                                                               survival in both generations.
Short-Term Dermal (1-30 days)....  Dermal study          LOC for MOE = 100    Dermal Developmental Study--Rat
                                   NOAEL = 100 mg/kg/                          LOAEL = 250 mg/kg/day based on
                                    day (dermal                                decreased fetal body weight;
                                    absorption rate =                          increased incidences of fetal
                                    100%).                                     skeletal variations: Hypoplastic
                                   UFA = 10X...........                        or wavy ribs, incompletely
                                   UFH = 10X...........                        ossified lumbar vertebral arches,
                                   FQPA SF = 1X........                        and incompletely ossified ischia
                                                                               or pubes; and reduced number of
                                                                               thoracic vertebral and rib
                                                                               ossification sites.
Short-Term Inhalation (1-30 days)  Inhalation (or oral)  LOC for MOE = 1000   Prenatal Developmental Toxicity--
                                    study                                      Rat Developmental LOAEL = 25 mg/
                                   NOAEL = 10 mg/kg/day                        kg/day, based upon decreased mean
                                    (inhalation                                fetal weights, and retardation in
                                    absorption rate =                          skeletal development evidenced by
                                    100%).                                     an increased number of litters
                                   UFA = 10X...........                        with any variation and by
                                   UFH = 10X...........                        decreased number of caudal
                                   FQPA SF = 10X.......                        vertebral and metacarpal
                                                                               ossification sites.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). M = male. F = female. FOB = functional observation battery.

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 to 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 DEEMTM 
(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 or PCT information in the dietary assessment for 
sulfentrazone. Tolerance level residues and 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

[[Page 41085]]

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 non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and 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. 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 post-application dermal exposure from contact with treated 
residential and recreational turf home lawns and golf courses. For 
adult handlers, dermal and inhalation exposures were aggregated for the 
short-term assessment. Because the level of concern for dermal 
exposures (MOEs less than 100) and inhalation exposure (MOEs less than 
1,000) are different, a total aggregate risk index (ARI) approach was 
used for adult handlers instead of the MOE approach. ARIs of less than 
1 indicate risks are not of concern. Children, ages 11 < 16 years old 
and 6 < 11 years old, were assessed for post-application dermal 
exposure from contact with treated residential and recreational turf 
(home lawns and golf courses). Children, ages 1 < 2 years old, were 
assessed for post-application dermal and incidental oral (hand-to-
mouth, object-to-mouth, soil ingestion and episodic ingestion of 
granules) exposure to residential turf/home lawns.
    For the short-term exposure duration, the post-application exposure 
scenarios that were combined for children 1 < 2 years old are the 
dermal and hand-to-mouth scenarios. This combination should be 
considered a protective estimate of children's exposure to pesticides 
used on turf. For the intermediate-term exposure duration, the only 
potential post-application exposure scenario is soil ingestion. 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 (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. 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.
    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 for all scenarios except for inhalation 
exposure, where a 10X FQPA SF factor has been retained due to the lack 
of an appropriate inhalation study. That decision is based on the 
following findings:
    i. The toxicity database for sulfentrazone is complete with the 
exception of a 28-day inhalation study in rats. A 10X FQPA SF has been 
retained for inhalation exposure scenarios due to this data gap.
    ii. There is no indication that sulfentrazone is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional safety factors to account for neurotoxicity.
    iii. There is evidence of increased quantitative susceptibility 
following in utero exposure in the oral and dermal developmental 
toxicity studies in rat 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 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.

[[Page 41086]]

    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 3.2% of the aPAD for females 13-49 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sulfentrazone from food and water will utilize 4.2% 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-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).
    Sulfentrazone 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 sulfentrazone.
    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 an aggregate MOE of 280 for 
children 1-2 years old, and an ARI of 3.9 for the general U.S. 
population and adult males. Because EPA's level of concern for 
sulfentrazone is an MOE of 100 or below and/or and ARI of 1 or below, 
this MOE and ARI 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).
    Sulfentrazone is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to sulfentrazone.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 2,400 for children 1-2 years old, the only population 
subgroup of concern. Because EPA's level of concern for sulfentrazone 
is an MOE of 100 or below, this MOE is not of concern.
    5. 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.
    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 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; 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 United Nations 
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 MRLs established for sulfentrazone on the 
subject crops in this rule.

C. Response to Comments

    A comment was received objecting generally to the use of this 
chemical stating that the ``* * * product should [sic] not be approved 
to be manufactured or sold anywhere on earth * * *'' The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by section 408 of 
the FFDCA states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This comment appears to be 
directed at the underlying statute and not EPA's implementation of it; 
the commenter has made no contention that EPA has acted in violation of 
the statutory framework.

D. Revisions to Petitioned-For Tolerances

    The tolerances proposed in the petitions have been revised as 
follows: the rhubarb tolerance is being set at 0.15 ppm instead of 0.2 
ppm; the turnip root tolerance is being set at 0.15 ppm instead of 0.2 
ppm; the turnip top tolerance is being set at 0.60 ppm instead of 0.7 
ppm; the wheat forage tolerance is being set at 0.50 ppm instead of 
0.45 ppm; the wheat hay tolerance is being set at 0.30 instead of 0.20 
ppm; the wheat grain tolerance is being set at 0.15 ppm instead of 0.20 
ppm; the wheat straw tolerance is being set at 1.5 ppm instead of 1.4 
ppm. EPA revised the tolerance levels based on analysis of the residue 
field trial data and by using the organization for economic cooperation 
and development (OECD) tolerance calculation procedures.
    Tolerances are not being established at this time for alfalfa 
forage, hay, and seed and clover forage, hay, and seed due to the need 
for additional residue data and a ruminant feeding study.

V. Conclusion

    Therefore, tolerances are established for residues of 
sulfentrazone, (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its 
metabolites 3-hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in section 180.498(a)(2) in or on 
rhubarb at 0.15 ppm; turnip roots at 0.15 ppm; turnip tops at 0.60 ppm; 
sunflower subgroup 20B at 0.20 ppm; citrus fruit group 10-10 at 0.15 
ppm; low growing berry group 13-07 at 0.15 ppm; tree nut group 14 at 
0.15 ppm; pistachio at 0.15 ppm; and section 180.498 (c) tolerances

[[Page 41087]]

with regional registrations for wheat forage at 0.50 ppm; wheat hay at 
0.30 ppm; wheat grain at 0.15 ppm; wheat straw at 1.5 ppm; and cowpea, 
succulent at 0.15 ppm.
    In addition, the following tolerances are being removed as 
unnecessary in section 180.498(a)(2), sunflower seed, and strawberry, 
and in section 180.498(b), flax seed and strawberry.
    Lastly, the tolerance for ``bean, lima, succulent'' is being moved 
from section 180.498(a)(2) to section 180.498(c).

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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: July 3, 2012.
Lois Rossi,
Director, Registration Division, Office Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.498 is amended by:
0
i. In the table to paragraph (a)(2), remove the entries for ``bean, 
lima, succulent,'' ``sunflower, seed,'' and ``strawberry'', and add 
alphabetically new entries as shown below.
0
ii. Revise paragraphs (b) and (c).
    The added and revised text read as follows:

Sec.  180.498  Sulfentrazone; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, group 13-07...........................          0.15
 
                                * * * * *
Fruit, citrus, group 10-10................................          0.15
 
                                * * * * *
Nut, tree, group 14.......................................          0.15
 
                                * * * * *
Pistachio.................................................          0.15
Rhubarb...................................................          0.15
 
                                * * * * *
Sunflower subgroup 20B....................................          0.20
Turnip, roots.............................................          0.15
Turnip, tops..............................................          0.60
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. Tolerances with 
regional registration 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-methyl-5-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-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, calculated as the stoichiometric 
equivalent of sulfentrazone in or on the following commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent....................................           0.15
Cowpea, succulent........................................           0.15
Wheat, forage............................................           0.50
Wheat, grain.............................................           0.15
Wheat, hay...............................................           0.30
Wheat, straw.............................................           1.5
------------------------------------------------------------------------

[[Page 41088]]

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[FR Doc. 2012-17020 Filed 7-11-12; 8:45 am]
BILLING CODE 6560-50-P