[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Rules and Regulations]
[Pages 18230-18235]
[FR Doc No: 2017-07819]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0171; FRL-9959-25]

Pyroxasulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective April 18, 2017. Objections and
requests for hearings must be received on or before June 19, 2017, 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-2016-0171, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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-2016-0171 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 19, 2017. 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-2016-0171, 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 Tolerances

    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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 6E8454)
by IR-4, Rutgers University, 500 College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of pyroxasulfone (3-
[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-
yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole) and its
metabolites (5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4- carboxylic acid (M-3); 5-(difluoromethoxy)-3-
(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic acid (M-25); 3-[1-
carboxy-2-(5,5-dimethyl-4,5-dihydroisoxazol-3-ylthio)ethylamino]-3-
oxopropanoic acid (M-28); and 5-(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic acid (M-1))
calculated as the stoichiometric equivalent of pyroxasulfone in or on
the raw agricultural commodity sunflower subgroup 20B at 0.2 parts per
million. That document referenced a summary of the petition prepared by
K-I Chemical U.S.A. Inc., the registrant, which is available in the
docket, http://www.regulations.gov. A comment supporting IR-4's
petition requesting this tolerance was received in response to the
notice of filing.
    In the Federal Register of December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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
5F8417) by K-I Chemical USA. Inc., 11 Martine Ave., Suite 970, White
Plains, NY 10606. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide,
pyroxasulfone (3-[(5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)
pyrazole-4-ylmethylsulfonyl]-4,5-dihydro-5,5-dimethyl-1,2-oxazole) and
its metabolites in or on dried shelled peas and beans (crop subgroup
6C) at 0.15 ppm, pea hay at 0.40 ppm, pea vines at 0.20 ppm, cowpea hay
at 0.07 ppm, cowpea forage at 3.0 ppm, flax at 0.07 ppm, peanut at 0.20
ppm, peanut hay at 3.0 ppm, peanut meal at 0.40 ppm, and vegetable,
foliage of legume, except soybean, subgroup 7A at 3.0 ppm. That
document referenced a summary of the petition prepared by K-I Chemical
U.S.A. Inc., the registrant, which is available in docket number EPA-
HQ-OPP-2015-0787, http://www.regulations.gov.
    The December 20, 2016 notice of filing supersedes a notice of
filing published in the Federal Register of June 22, 2016 (81 FR 40594)
(FRL-9947-32), which was based on an earlier version of the same
petition (5F8417). Following that June 2016 publication, K-1 amended
its petition to include additional crops and adjust the tolerance
levels requested. The December 20, 2016 document provided notice of
that updated petition. Although no comments were received in response
to the December 20, 2016 notice of filing, one comment was received in
response to the June 22, 2016 notice. EPA is carrying that earlier
comment forward as a comment on the petition noticed in December 2016
and provides a response to that comment in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established and also modified some of the crop definitions. 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 pyroxasulfone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyroxasulfone
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 testing of pyroxasulfone in mice,
rats and dogs produced a variety of adverse effects in several target
organs, but the most sensitive effect is neurotoxicity in dogs. Effects
seen in animal studies ranged from cardiac toxicity (increased
cardiomyopathy in mice and rats), liver toxicity (centrilobular
hepatocellular hypertrophy, histopathological and/or clinical
pathological indicators), neurotoxicity characterized by axonal/myelin
degeneration in the sciatic nerve (dog, mouse and rat) and spinal cord
sections (dog), skeletal muscle myopathy, kidney toxicity (increased
incidence of chronic progressive nephropathy in dogs and retrograde
nephropathy in mice), urinary bladder mucosal hyperplasia,
inflammation, and urinary bladder transitional cell papillomas (rats).
Decreased body weight and enzyme changes were noted in some studies.
Toxic adverse effects (impaired hind limb function, ataxia, hind limb
twitching and tremors; increased creatine kinase, aspartate
aminotransferase; axonal/myelin degeneration of the sciatic nerve and
spinal cord sections) in dogs occurred at >=10 mg/kg/day doses while in
the mouse toxic adverse effects (degeneration of sciatic and trigeminal
nerve axons and their associated myelin sheaths and chronic progressive
nephropathy, renal tubular adenomas) occurred at higher doses (131 mg/
kg/day and above).
    Comparing effects by route of administration, pyroxasulfone was
moderately toxic to rats following a 4-week dermal exposure producing
local inflammation and systemic effects of minimal to mild cardiac
myofiber degeneration at the limit dose of 1,000 mg/kg/day with a NOAEL
of 100 mg/kg/day. No adverse effects were noted in an inhalation study
following exposure for 28 days at 200 mg/m\3\/day (equivalent to 52.2
mg/kg/day oral dose), the highest dose tested of an aerosol dust.
    In cancer studies in mice and rats, renal tubular adenomas were
observed in male mice at a dietary dose of 0.6 and 255 mg/kg/day (but
not at an intermediate dose of 18 mg/kg/day) and urinary bladder
transitional cell papillomas were observed in male rats at 42 and 84
mg/kg/day. Based on available information, the Agency concluded that
the kidney adenomas in male mice were not treatment-related.

The Agency considered the transitional cell bladder tumors in male rats
to be treatment-related based on statistically significant trends for
urinary bladder transitional cell papillomas and combined papillomas
and carcinomas, the occurrence of preneoplastic lesions at 42 and 84
mg/kg/day and the rare occurrence of bladder transitional cell tumors.
The Agency concluded that the mode of action for bladder tumors has
been adequately established based on submitted data that support both a
dose-response and temporal concordance of the key events and bladder
tumors. The available data indicate that the formation of urinary
bladder calculi is the prerequisite for subsequent hyperplasia and
neoplasia and that tumors do not develop at doses too low to produce
calculi. The Agency has determined that the quantification of risk
using a non-linear approach (i.e., RfD) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to pyroxasulfone. There is a clear threshold of 1,000 ppm
(42.55 mg/kg/day) for tumorigenesis. A point of departure (POD) of 50
ppm (2.0 mg/kg/day) is not expected to result in urinary bladder
calculi formation which is a prerequisite for subsequent hyperplasia
and neoplasia.
    Pyroxasulfone did not exhibit developmental toxicity in the rat
developmental toxicity study at the limit dose of 1,000 mg/kg/day and
it exhibited slight developmental toxicity in rabbits (reduced fetal
weight and resorptions) at the limit dose of 1,000 mg/kg/day. However,
developmental effects were noted in post-natal day (PND) 21 offspring
at 300 mg/kg/day in the rat developmental neurotoxicity (DNT) study
characterized as decreased brain weight and morphometric changes.
Developmental effects in the rabbit developmental study and DNT study
occurred in the absence of maternal toxicity, indicating potential
increased quantitative susceptibility of offspring. In a reproductive
toxicity in rats reduced pup weight and body weight gains during
lactation occurred at similar doses causing pronounced maternal
toxicity (reduced body weight, body weight gain and food consumption
and increased kidney weight, cardiomyopathy and urinary bladder mucosal
hyperplasia with inflammation).
    Pyroxasulfone did not produce immunotoxic effects in mice following
dietary feeding for 28 days up to 4,000 ppm (633/791 mg/kg/day, M/F) or
in rats at dietary concentrations of 7,500 ppm (529/570 mg/kg/day in M/
F).
    Specific information on the studies received and the nature of the
adverse effects caused by pyroxasulfone 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 title ``Pyroxasulfone Human Health
Risk Assessment for the Section 3 New Uses of Pyroxasulfone on Crop
Subgroup 6C, Sunflower Subgroup 20B, Flax, and Peanut'' on page 44 in
docket ID number EPA-HQ-OPP-2016-0171.

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 pyroxasulfone used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Pyroxasulfone 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
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Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1.0 mg/  Developmental neurotoxicity study
 including infants and children).   day.                  kg/day.              (DNT) in rats.
                                   UFA = 10x...........  aPAD = 1.0 mg/kg/    The LOAEL of 300 mg/kg/day is
                                   UFH = 10x...........   day.                 based on decreased brain weight
                                   FQPA SF = 1x........                        in both sexes, reduced thickness
                                                                               of the hippocampus, corpus
                                                                               callosum and cerebellum in PND 21
                                                                               female offspring.
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Chronic dietary (All populations)  NOAEL = 2 mg/kg/day.  Chronic RfD = 0.02   One- year chronic dog study.
                                   UFA = 10x...........   mg/kg/day.          The LOAEL of 10 mg/kg/day is based
                                   UFH = 10x...........  cPAD = 0.02 mg/kg/    on impaired hind limb function,
                                   FQPA SF = 1x........   day.                 ataxia, hind limb twitching and
                                                                               tremors; clinical pathology:
                                                                               Increased creatine kinase,
                                                                               aspartate aminotransferase;
                                                                               axonal/myelin degeneration of the
                                                                               sciatic nerve and spinal cord
                                                                               sections.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause
                                     crystals with subsequent calculi formation resulting in cellular damage of
                                        the urinary tract. Risk is quantified using a non-linear (i.e., RfD)
                                                                      approach.
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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).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyroxasulfone, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyroxasulfone
tolerances in 40 CFR 180.659. EPA assessed dietary exposures from
pyroxasulfone 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 pyroxasulfone. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) 2003-2008 National Health and
Nutrition Survey/What We Eat in America (NHANES/WWEIA). As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance level residues adjusted for metabolites which are not in the
tolerance expression.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and
tolerance level residues adjusted for metabolites which are not in the
tolerance expression.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to pyroxasulfone. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for pyroxasulfone. 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 pyroxasulfone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyroxasulfone. 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
pyroxasulfone for acute exposures are estimated to be 16.7 parts per
billion (ppb) for surface water and 210 ppb for ground water. EDWCs of
pyroxasulfone for chronic exposures for non-cancer assessments are
estimated to be 4.5 ppb for surface water and 174 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 210 ppb was used to assess
the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration value of 174 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).
    Pyroxasulfone is not registered for any specific use patterns that
would result in residential exposure.
    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 pyroxasulfone to share a common mechanism of
toxicity with any other substances, and pyroxasulfone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyroxasulfone 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://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. Pyroxasulfone did not
exhibit developmental toxicity in the rat guideline study at the limit
dose of 1,000 mg/kg/day and it exhibited slight developmental toxicity
in rabbits (reduced fetal weight and resorptions) at the limit dose of
1,000 mg/kg/day. However, developmental effects were noted in PND 21
offspring at 300 mg/kg/day in the rat developmental neurotoxicity (DNT)
study characterized as decreased brain weight and morphometric changes.
Developmental effects in the rabbit developmental study and DNT study
occurred in the absence of maternal toxicity, indicating potential
increased quantitative susceptibility of offspring. In a rat
reproductive toxicity study, reduced pup weight and body weight gains
during lactation occurred at similar doses causing pronounced maternal
toxicity (reduced body weight, body weight gain and food consumption
and increased kidney weight, cardiomyopathy and urinary bladder mucosal
hyperplasia with inflammation).
    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 pyroxasulfone is complete.
    ii. Available data indicates that pyroxasulfone produces neurotoxic
effects in rats. The toxicity database includes specific acute and
subchronic neurotoxicity tests, as well as a developmental
neurotoxicity study (DNT). Although the DNT indicated offspring are
more sensitive to neurotoxic effects of pyroxasulfone, the dose-
response is well characterized for neurotoxicity and a NOAEL is

identified; therefore, there is no residual uncertainty with regard to
neurotoxic effects for which a 10X must be retained.
    iii. As discussed in Unit III.D.2., there is evidence of increased
quantitative susceptibility of fetuses and offspring following in utero
or post-natal exposure to pyroxasulfone (based on a DNT study in rats
and a developmental study in rabbits). In rabbits, developmental
toxicity was only seen at the limit dose of 1000 mg/kg/day as reduced
fetal weight and increased fetal resorptions with a NOAEL of 500 mg/kg/
day for these effects, compared to no maternal toxicity at these doses.
In a DNT study in rats, offspring toxicity was seen at 300 mg/kg/day
compared to no maternal toxicity at 900 mg/kg/day. Notwithstanding, the
Agency concludes that there is no residual uncertainty concerning these
effects. The available studies show clear NOAELs and LOAELs for these
effects, which are occurring only at doses much higher than the
endpoints on which the Agency is regulating.
    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 pyroxasulfone in drinking water. These
assessments will not underestimate the exposure and risks posed by
pyroxasulfone.

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 pyroxasulfone will occupy 3.7% of the aPAD for all infants less than
1-year-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
pyroxasulfone from food and water will utilize 49% of the cPAD for all
infants less than 1-year-old, the population group receiving the
greatest exposure. There are no residential uses for pyroxasulfone.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
    Short- and intermediate-term adverse effects were identified;
however, pyroxasulfone is not registered for any use patterns that
would result in short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or 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 short-term risk), no further assessment of short- or
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for pyroxasulfone.
    4. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to pyroxasulfone. Therefore, based on the results of the
chronic risk assessment discussed in Unit III.E.2., pyroxasulfone is
not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyroxasulfone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography/triple quadrupole mass spectrometry (LC/MS/MS)) 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 any MRLs for residues of
pyroxasulfone in or on any of the commodities in this document.

C. Response to Comments

    One comment was received in response to the June 22, 2016 Notice of
Filing (81 FR 40594) (FRL-9947-32). The comment stated in part that
most Americans ``don't need or want more toxic chemicals'' and that EPA
should deny this submission. The Agency 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. The citizen's comment does not
provide any information upon which the Agency could base a decision
deny the petition.

D. Revisions to Petitioned-For Tolerances

    The sunflower subgroup 20B tolerance is being established at 0.30
ppm instead of the proposed level of 0.2 ppm. This is because the
petitioner did not convert the metabolites to parent equivalents and
when those total residues are put into the tolerance calculator the
correct value is 0.30 ppm. Also, based on the Agency's review of the
residue data, the tolerances for peanut and peanut hay are being
established at 0.30 ppm and 4.0 ppm, respectively. In addition,
separate tolerances are not being established on field pea hay and
vines and cowpea hay

and forage because they will be covered by the tolerance being
established on ``vegetable, foliage of legume, except soybean, subgroup
7A.''

V. Conclusion

    Therefore, tolerances are established for residues of
pyroxasulfone, including its metabolites and degradates, in or on:
Flax, seed at 0.07 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C at 0.15 ppm; peanut at 0.30 ppm; peanut, hay at 4.0 ppm;
peanut, meal at 0.40 ppm; sunflower subgroup 20B at 0.30 ppm; and
vegetable, foliage of legume, except soybean, subgroup 7A at 3.0 ppm.

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). 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 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: February 24, 2017,
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 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.  180.659, add paragraph (a)(5) to read as follows:

Sec.  180.659  Pyroxasulfone; tolerances for residues.

    (a) * * *
    (5) Tolerances are established for residues of the herbicide
pyroxasulfone, 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
pyroxasulfone (3-[(5-difluoromethoxy-1-methyl-3-
(trifluoromethyl)pyrazol-4-ylmethylsulfonyl]-4,5-dihydro-5,5-dimethyl-
1,2-oxazole), and its metabolites, M-1 (5-difluoromethoxy-1-methyl-3-
trifluoromethyl-1H-pyrazol-4-yl) methanesulfonic acid), M-3 (5-
difluoromethoxy-1-methyl-3-trifluoromethyl-1H-pyrazol-4-carboxylic
acid), M-25 (5-difluoromethoxy-3-trifluoromethyl-1H-pyrazol-4-
yl)methanesulfonic acid) and M-28 (3-[1-carboxy-2-(5,5-dimethyl-4,5-
dihydroisoxazol-3-ylthio)ethylamino]-3-oxopropanoic acid) calculated as
the stoichiometric equivalent of pyroxasulfone, in or on the following
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Flax, seed.................................................         0.07
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.15
Peanut.....................................................         0.30
Peanut, hay................................................         4.0
Peanut, meal...............................................         0.40
Sunflower subgroup 20B.....................................         0.30
Vegetable, foliage of legume, except soybean, subgroup 7A..         3.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-07819 Filed 4-17-17; 8:45 am]
BILLING CODE 6560-50-P