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[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Rules and Regulations]
[Pages 54620-54626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21807]

[[Page 54620]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0712; FRL-9915-47]

Sulfentrazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
sulfentrazone in or on apple. The Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 12, 2014. Objections and 
requests for hearings must be received on or before November 12, 2014, 
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-2013-0712, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.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-2013-0712 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 
November 12, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0712, 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 CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (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.html. 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 December 30, 2013 (78 FR 79359) (FRL-
9903-69), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3E8202) by IR-4, 500 College Road East, Suite 201W, 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 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 apple at 0.15 
parts per million (ppm). That document 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 
determined that it is appropriate to establish the tolerance in or on 
apple for the combined residues of the free and conjugated forms of the 
herbicide sulfentrazone, 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. The reason for this decision is discussed 
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

[[Page 54621]]

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.
    Subchronic and chronic toxicity studies in rats, mice, and dogs 
identified the hematopoietic system as the target of sulfentrazone. 
Sulfentrazone inhibits the enzyme protoporphyrinogen oxidase (PPO) in 
target plants, and the results of subchronic and chronic toxicity 
studies in mammalian systems are consistent with PPO inhibition. 
Disruption of heme biosynthesis was indicated by signs of anemia, and 
decreases in hematocrit (Hct), hemoglobin (HGB), and mean corpuscular 
volume (MCV) in mice, rats, and dogs at comparable dose levels from 
short- through long-term exposures without a significant increase in 
severity.
    Sulfentrazone caused developmental effects when administered via 
the oral (rats and rabbits) and dermal (rat only) routes of exposure. 
Developmental effects in rats and rabbits consisted of reductions in 
the number of implantations in rats, and increases in early resorptions 
and reduction in live fetuses per litter in rats and rabbits. Surviving 
rat fetuses exhibited reduced/delayed skeletal ossifications, and 
decreased fetal body weights. Developmental effects in rats were seen 
in the absence of maternal toxicity. In contrast with the rat studies, 
developmental effects in rabbits were observed at a maternally toxic 
dose, where clinical signs of toxicity included hematuria (red blood 
cells in urine), abortions, and decreased body-weight gains. In the 2-
generation reproductive toxicity study in rats, developmental effects 
included an increased duration of gestation, reduced prenatal viability 
(fetal and litter), reduced litter size, and an increased number of 
stillborn pups. Pup body-weight deficits, along with reduced pup and 
litter postnatal survival, were also observed. All of the offspring 
effects were reported in the presence of mild maternal toxicity 
(decreased body weight and body-weight gain, particularly in 
F1 females). No systemic toxicity was seen via the dermal 
route up to the limit dose in a 28-day dermal toxicity study in adult 
non-pregnant rabbits. In a dermal developmental study in rats, there 
was an increased quantitative fetal susceptibility. While no maternal 
effects were observed up to the highest dose tested, fetal effects were 
observed at this dose, and consisted of decreased body weights, 
increased incidences of fetal variations, hypoplastic or wavy ribs, 
incompletely ossified lumbar vertebral arches, incompletely ossified 
ischia or pubis, and a reduced number of thoracic vertebral and rib 
ossification sites.
    In the 26-day inhalation toxicity study, effects that were 
considered treatment related and adverse effects occurred only at the 
highest concentration tested. Systemic effects at this concentration 
consisted of significant reductions in red blood cell (RBC) parameters 
including RBC count, HGB concentrations, Hct, MCV, mean corpuscular HGB 
(MCH), and/or reticulocytes in both sexes. Portal-of-entry effects in 
this study consisted of an increased incidence of minimal nasal 
respiratory epithelial hyperplasia in both sexes as well as minimal 
laryngeal epithelial attenuation in all test material exposure groups. 
The effects on hematological parameters were reversible after 28 days 
of recovery, while the nasal injury persisted.
    In an acute neurotoxicity (ACN) study in rats, effects consisted of 
an increased incidence of clinical signs of toxicity (staggered gait, 
splayed hind limbs, and abdominal gripping), changes in functional-
observation battery (FOB) parameters, and decreased motor activity at a 
high dose level. Complete recovery was observed by day 14, and there 
was no evidence of neuropathology. In a rat subchronic neurotoxicity 
(SCN) study, clinical signs of toxicity, increased motor activity, and/
or decreased body weights, body-weight gain, and food consumption were 
also observed with no evidence of neuropathology. A published, non-
guideline developmental toxicity study in the rat did not conclusively 
demonstrate developmental neurotoxicity and contained several 
shortcomings that limit its use for regulatory purposes, including the 
lack of a no-observed-adverse-effect-level (NOAEL) (DeCastro VL, 
Destefani CR, Diniz C, Poli P., 2007, Evaluation of neurodevelopmental 
effects on rats exposed prenatally to sulfentrazone. Neurotoxicology 
28(6):1249-59). The reported 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 but with a well-
defined NOAEL.
    In the 28-day rat immunotoxicity study, there were no effects on 
the immune system and systemic effects consisted of reduced body 
weight, and increased absolute and relative spleen weights at the 
highest dose tested. Carcinogenicity studies in rats and mice showed no 
evidence of increased incidence of tumor formation due to treatment 
with sulfentrazone, and the EPA has 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. There is no evidence 
that sulfentrazone is mutagenic in bacterial cells or 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 NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document: 
``Sulfentrazone--Preliminary Human-Health Risk Assessment for 
Registration Review and the Risk Assessment for the Section 3 
Registration Request for a New Use on Apples'' at pp. 44-49 in docket 
ID number EPA-HQ-OPP-2013-0712.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies

[[Page 54622]]

toxicological points of departure (POD) and levels of concern 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 the NOAEL and the LOAEL are identified. 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 Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Sulfentrazone for Use in Human Health Risk Assessment
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                                    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
                                   UFH = 10x...........  aPAD = 0.14 mg/kg/   Offspring Toxicity LOAEL = 33 (M)
                                   FQPA SF = 1x........   day.                 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  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity (ACN) Study--
 including infants and children).   day.                  kg/day.              Rat
                                   UFA = 10x...........  aPAD = 2.5 mg/kg/    LOAEL = 750 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased incidence of clinical
                                   FQPA SF = 1x........                        signs and FOB parameters and
                                                                               decreased motor activity.
Chronic dietary (All populations)  NOAEL = 14 mg/kg/day  Chronic RfD = 0.14   2-generation Reproductive Toxicity
                                   UFA = 10x...........   mg/kg/day.           Study--Rat
                                   UFH = 10x...........  cPAD = 0.14 mg/kg/   Offspring Toxicity LOAEL = 33 (M)
                                   FQPA SF = 1x........   day.                 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.
Incidental oral short- (1 to 30    NOAEL = 14 mg/kg/day  LOC for MOE = 100..  2-Generation Reproductive Toxicity
 days) and intermediate-term (1-6  UFA = 10x...........                        Study--Rat
 months).                          UFH = 10x...........                       Offspring LOAEL = 33 mg/kg/day
                                   FQPA SF = 1x........                        based on decreased pup body
                                                                               weights and reduced postnatal
                                                                               survival in both generations.
Dermal short-term (1 to 30 days).  Dermal study NOAEL =  LOC for MOE = 100..  Dermal Developmental Study--Rat
                                    100 mg/kg/day.                            LOAEL = 250 mg/kg/day based on
                                   UFA = 10 x..........                        decreased fetal body weight;
                                   UFH = 10 x..........                        increased incidences of fetal
                                   FQPA SF = 1x........                        skeletal 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.
Short-term (1-30 days) inhalation  Portal-of-entry       LOC for MOE = 30...  Portal-of-entry LOAEL = 1.71 mg/L
                                    NOAEL = 0.256 mg/L,                        based on an increased incidence
                                    HEC = 0.054 mg/L,                          of minimal nasal respiratory
                                    HED = 1.55.                                epithelial hyperplasia in male
                                   mg/kg/day UFA = 3x..                        and female rats.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Sulfentrazone is classified as not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
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). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). HEC = human-equivalent concentration. HED = human-equivalent
  dose.

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, and EPA performed separate acute risk assessments 
for females 13 to 49 years old and for the general population, 
including infants

[[Page 54623]]

and children, based on different endpoints and acute population 
adjusted doses (aPADs). In estimating acute dietary exposures, EPA used 
the Dietary Exposure Evaluation Model, Food Consumption Intake Database 
(DEEM-FCID, ver. 3.16), which incorporates consumption data from United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA assumed tolerance-level residues, 100 
percent crop treated (PCT), and DEEM (ver. 7.81) default processing 
factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, ver. 3.16, which incorporated 
consumption data from the USDA's NHANES/WWEIA; 2003-2008. As to residue 
levels in food, EPA assumed tolerance-level residues, 100 PCT, and DEEM 
(ver. 7.81) default processing factors.
    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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
sulfentrazone for acute exposures are estimated to be 37.3 parts per 
billion (ppb) for surface water and 134 ppb for ground water; and for 
chronic exposures for non-cancer assessments are estimated to be 5.3 
ppb for surface water and 98 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 134 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 98 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 uses that could result in 
residential exposures: Residential home lawns/turf and recreational 
turf, such as golf courses. EPA assessed residential exposures using 
the following assumptions: Adults were assessed for potential short-
term dermal and inhalation handler exposures from applying 
sulfentrazone to residential turf/home lawns and for short-term 
postapplication dermal exposure from contact with treated residential 
and recreational turf.
    Children, ages 11 home lawns.
    The recommended adult residential exposure scenario for use in the 
aggregate assessment reflects short-term dermal exposure from 
applications to turf via backpack sprayer. The recommended residential 
exposure scenario for use in the combined short- and intermediate-term 
aggregate assessment for children ages 1 or postapplication inhalation risk estimates 
were not combined with dermal or oral risk estimates in the aggregate 
risk assessment since the toxicological effects in the inhalation 
toxicological study were portal-of-entry and were different from those 
seen in the dermal and oral toxicological studies. 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different

[[Page 54624]]

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. That decision is based on the following 
findings:
    i. The toxicity database for sulfentrazone is complete.
    ii. In the ACN and SCN studies, observed effects included changes 
in motor activity and FOB parameters, clinical signs, and body-weight 
decrements. There is low concern for neurotoxicity since:
    1. Effects were seen at relatively high doses;
    2. Effects occurred in the absence of neuropathology;
    3. There is no evidence of neurotoxicity in other available studies 
in the toxicity database;
    4. Effects are well-characterized with clearly established NOAEL/
LOAEL values; and
    5. The selected PODs are protective of these effects.
    iii. There was evidence for increased quantitative susceptibility 
following oral and dermal exposures in the developmental toxicity 
studies in rats. Although developmental toxicity was observed at lower 
doses than maternal toxicity in both studies in the rat, the concern is 
low based on the following considerations:
    1. The toxicology database for assessing pre- and postnatal 
susceptibility is complete;
    2. There are clear NOAELs and LOAELs for the developmental effects 
observed via both the oral and dermal routes;
    3. The PODs used for assessing dietary and dermal exposure risks 
are based on developmental and/or offspring toxicity;
    4. The portal-of-entry effects seen in the 26-day inhalation study 
are protective of the developmental toxicity; and
    5. There are no residual uncertainties for pre- and/or postnatal 
toxicity.
    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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
sulfentrazone will occupy 6.7% of the aPAD for females 13-49 years old, 
and 1.1% of the aPAD for all infants less than 1 year old, the 
population group receiving the greatest exposure for all populations 
other than females 13-49 years old.
    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 7.1% 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 480 for adults. 
Because EPA's level of concern for sulfentrazone is a MOE of 100 or 
below, this MOE is not of concern.
    4. Short- and intermediate-term risk. Combined short- and 
intermediate-term aggregate exposures take into account short- and 
intermediate-term residential exposures 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 exposures, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short- and intermediate-term residential exposures to 
sulfentrazone.
    Using the exposure assumptions described in this unit for combined 
short- and intermediate-term exposures, EPA has concluded that the 
combined short- and intermediate-term food, water, and residential 
exposures result in an aggregate MOE of 260 for children 1-2 years old, 
the population subgroup for children with the greatest exposure. 
Because EPA's level of concern for sulfentrazone is a MOE of 100 or 
below, this MOEs are 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, chemical name 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 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.

[[Page 54625]]

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.
    The Codex has not established a MRL for sulfentrazone.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a 
general objection to the presence of any sulfentrazone residues on 
apple or any other crop. 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 citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 
framework. The Agency has concluded after this assessment, that there 
is a reasonable certainty that no harm will result from aggregate human 
exposure to sulfentrazone.

D. Revisions to Petitioned-For Tolerances

    EPA was petitioned to establish a tolerance in or on apple for 
residues of sulfentrazone and its metabolite HMS; however, upon review 
of the data supporting the petition, the Agency has determined that the 
apple tolerance should be established on the combined residues of the 
free and conjugated forms of sulfentrazone, including 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. EPA previously reviewed metabolism data 
and determined that the residues of concern are the parent compound, 
sulfentrazone, and the metabolites HMS and DMS (free and conjugated) in 
all crops except soybean seed, where the residues of concern are 
sulfentrazone and the metabolite HMS. Samples of raw agricultural and 
processed commodities from the apple studies were analyzed for residues 
of sulfentrazone and its metabolites DMS and HMS, and EPA is 
establishing an apple tolerance based upon those analyses.

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 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 apple at 0.15 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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

[[Page 54626]]

and pests, Reporting and recordkeeping requirements.

    Dated: September 4, 2014.
Lois Rossi,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.498, add alphabetically the following commodity to the 
table in paragraph (a)(2) to read as follows:

Sec.  180.498  Sulfentrazone; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Apple...................................................            0.15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-21807 Filed 9-11-14; 8:45 am]
BILLING CODE 6560-50-P
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