[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Rules and Regulations]
[Pages 15977-15982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07740]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0072; FRL-9975-77]


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) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2018. Objections and 
requests for hearings must be received on or before June 12, 2018, 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-2017-0072, 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: Michael Goodis, 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: [email protected].

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/Title40/40tab_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-2017-0072 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 
June 12, 2018. 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-2017-0072, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 
6E8532) 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 part 180 be amended by establishing tolerances 
for residues of the herbicide sulfentrazone in or on Chia, dry seed at 
0.15 parts per million (ppm); Teff, forage at 0.50 ppm; Teff, grain at 
0.15 ppm; Teff, hay at 0.30 ppm; Teff, straw at 1.5 ppm; Stalk and stem 
vegetable subgroup 22A at 0.15 ppm; Vegetable, brassica, head and stem, 
group 5-16 at 0.20 ppm; Brassica, leafy greens, subgroup 4-16B at 0.60 
ppm; and Nut, tree, group 14-12 at 0.15 ppm. The petition also 
requested to remove the tolerances for Asparagus at 0.15 ppm; Brassica, 
head and stem, subgroup 5A at 0.20 ppm; Brassica, leafy greens, 
subgroup 5B at 0.40 ppm; Nut, tree, group 14 at 0.15 ppm;

[[Page 15978]]

Pistachio at 0.15 ppm; and Turnip, tops at 0.60 ppm. That document 
referenced a summary of the petition prepared by FMC, 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.

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.
    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 occurred only at the highest 
concentration tested. Systemic effects at this concentration consisted 
of significant reductions in red blood cell (RBC) parameters 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 two-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 no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the

[[Page 15979]]

toxicity studies can be found at http://www.regulations.gov in the 
document titled Sulfentrazone--Human Health Risk Assessment for a 
Section 3 Registration Request to Add New Uses on Chia and Teff; an 
Amended Use on Mint; and Crop Group Conversions for Tree Nut Group 14-
12, Stalk and Stem Vegetable Subgroup 22A; Vegetable, Brassica, Head 
and Stem, Group 5-16; and Brassica, Leafy Greens, Subgroup 4-16B on 
pages 26-31 in docket ID number EPA-HQ-OPP-2017-0072.

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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for sulfentrazone used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 12, 2014 (79 FR 54620) 
(FRL-9915-47).

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 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 percent crop treated (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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    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 the acute dietary risk 
assessment, the water concentration value of 134 ppb was used to assess 
the contribution to drinking water. For the 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 post-application dermal exposure from contact with treated 
residential and recreational turf.
    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 
short-term dermal and incidental oral exposures (hand-to-mouth, object-
to-mouth, and episodic ingestion of granules), as well as short-term 
incidental oral soil ingestion scenarios from contact with residential 
turf/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-term aggregate 
assessment for children ages 1 < 2 years old reflects dermal and hand-
to-mouth exposures from post-application exposure to turf applications. 
This combination should be considered a protective estimate of 
children's exposure to pesticides used on turf since the incidental 
oral

[[Page 15980]]

scenarios are considered inter-related, likely occurring interspersed 
amongst each other across time; therefore, combining these scenarios 
would be overly conservative because of the conservative nature of each 
individual assessment. Further, this scenario is considered protective 
of potential post-application exposures to children, ages 6 < 11 and 11 
< 16 years old, as children 1-2 years old represent the population 
subgroup for children with the greatest exposure, and is therefore 
considered protective of other children population subgroups. 
Intermediate-term exposure is not expected.
    Chronic exposures are not expected and were not assessed. Finally, 
residential handler and/or post-application 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. 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 post-application 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to sulfentrazone will occupy 1.1% of the aPAD for all infants less than 
1-year-old and 6.7% of the aPAD for females 13-49 years old, the 
population groups 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 7.0% 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

[[Page 15981]]

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 490 for adults. Because EPA's 
level of concern for sulfentrazone is a MOE of 100 or below, this MOE 
is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
sulfentrazone is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
sulfentrazone.
    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 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: [email protected].

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.
    No Codex MRLs have been established for sulfentrazone on the crops 
cited in this document.

C. Response to Comments

    Two comments were received in response to the notice of filing. One 
was against the establishment of any tolerances for sulfentrazone and 
the other stated ``deny this application to change the tolerance on 
this product.''
    Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that these sulfentrazone tolerances are safe. The commenters have 
provided no information supporting a contrary conclusion.

V. Conclusion

    Therefore, tolerances are established for residues of sulfentrazone 
in or on Brassica, leafy greens, subgroup 4-16B at 0.60 ppm; chia, seed 
at 0.15 ppm; nut, tree, group 14-12 at 0.15 ppm; stalk and stem 
vegetable subgroup 22A at 0.15 ppm; teff, forage at 0.50 ppm; teff, 
grain at 0.15 ppm; teff, hay at 0.30 ppm; teff, straw at 1.5 ppm; and 
vegetable, Brassica, head and stem, group 5-16 at 0.20 ppm. In 
addition, the following existing tolerances are removed as unnecessary 
since they are superseded by the new tolerances: asparagus; Brassica, 
head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; nut, 
tree, group 14; pistachio; and turnip, tops.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action 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 action 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

[[Page 15982]]

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 action. In addition, this action does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act (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 (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 and pests, Reporting and 
recordkeeping requirements.

    Dated: April 3, 2018.
Michael Goodis,
Director, Registration Division, 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, in the table in paragraph (a)(2):
0
i. Remove the entries ``Asparagus''; ``Brassica, head and stem, 
subgroup 5A''; and ``Brassica, leafy greens, subgroup 5B''.
0
ii. Add alphabetically the entries ``Brassica, leafy greens, subgroup 
4-16B'' and ``Chia, seed''.
0
iii. Remove the entry ``Nut, tree, group 14''.
0
iv. Add alphabetically the entry ``Nut, tree, group 14-12''.
0
v. Remove the entry ``Pistachio''.
0
vi. Add alphabetically the entries ``Stalk and stem vegetable subgroup 
22A''; ``Teff, forage''; ``Teff, grain''; ``Teff, hay''; and ``Teff, 
straw''.
0
vii. Remove the entry ``Turnip, tops''.
0
viii. Add alphabetically the entry ``Vegetable, Brassica, head and 
stem, group 5-16''.
    The additions read as follows:


Sec.  180.498   Sulfentrazone; tolerances for residues.

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

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B.........................     0.60
Chia, seed.....................................................     0.15
 
                                * * * * *
Nut, tree, group 14-12.........................................     0.15
 
                                * * * * *
Stalk and stem vegetable subgroup 22A..........................     0.15
 
                                * * * * *
Teff, forage...................................................     0.50
Teff, grain....................................................     0.15
Teff, hay......................................................     0.30
Teff, straw....................................................      1.5
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16.................     0.20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-07740 Filed 4-12-18; 8:45 am]
 BILLING CODE 6560-50-P