[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Rules and Regulations]
[Pages 54259-54264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23002]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0334; FRLc-9983-29]


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. In addition, the established 
pyroxasulfone tolerance on cotton, undelinted seed is removed. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 29, 2018. Objections and 
requests for hearings must be received on or before December 28, 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-2017-0334, 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 L. 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.

[[Page 54260]]

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-2017-0334 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 
December 28, 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-2017-0334, 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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP 
7E8570 & 7E8585) by IR-4 Headquarters, Rutgers, The State University of 
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. 
The petitions requested that 40 CFR 180.659 be amended as follows:
    a. Amend 180.659(a)(1), by establishing a tolerance for residues of 
the herbicide pyroxasulfone, including its metabolites and degradates, 
determined by measuring only the sum of pyroxasulfone, 3-[[[5-
(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1 H-pyrazol-4-
yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and its 
metabolite, 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1 H-
pyrazol-4-carboxylic acid (M-3), calculated as the stoichiometric 
equivalent of pyroxasulfone, in or on the commodity: Cottonseed 
subgroup 20C at 0.04 parts per million (ppm). In addition, the 
petitioner requested removal of the established tolerance on Cotton, 
undelinted seed at 0.04 ppm (PP 7E8585).
    b. Amend 180.659(a)(5) by establishing a tolerance for residues of 
the herbicide pyroxasulfone, including its metabolites and degradates, 
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 commodities: Peppermint, oil at 0.48 ppm; 
peppermint, tops at 0.15 ppm; spearmint, oil at 0.48 ppm; spearmint, 
tops at 0.15 ppm; soybean, vegetable, succulent at 0.2 ppm (PP 7E8570); 
and Leaf petiole vegetable subgroup 22B at 0.3 ppm (PP 7E8585).
    c. Amend 180.659(c) Tolerances with regional registrations, by 
establishing a tolerance for residues of the herbicide pyroxasulfone, 
including its metabolites and degradates, 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 
commodities: Grass, forage at 0.5 ppm and grass, hay at 1.0 ppm (PP 
7E8570).
    These documents referenced a summary of each petition prepared by 
K-1 Chemical, USA Inc., the registrant, that are available in the 
docket, http://www.regulations.gov.
    One comment was received on the notice of filings. EPA's response 
to the comment is discussed in Unit IV.C.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is 
issuing tolerances that vary from what the petitioner sought. 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 their 
validity, completeness, and reliability as

[[Page 54261]]

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.
    The toxicology database for pyroxasulfone is adequate for 
evaluating and characterizing toxicity and selecting endpoints for 
purposes of this risk assessment. Pyroxasulfone acute toxicity to 
mammals is low by all routes of exposure. Subchronic and chronic oral 
studies in mice, rats and dogs produced a variety of effects including 
cardiac toxicity (increased cardiomyopathy), liver toxicity 
(centrilobular hepatocellular hypertrophy, histopathological and/or 
clinical pathological indicators), kidney toxicity (nephropathy), 
neurotoxicity (impaired hind limb function, ataxia, tremors, sciatic 
nerve lesions, axonal/myelin degeneration in the sciatic nerve and 
spinal cord sections), skeletal muscle myopathy, urinary bladder 
mucosal hyperplasia, and urinary bladder transitional cell papillomas. 
Dogs appear to be the most sensitive species in regard to neurotoxic 
effects of pyroxasulfone via the oral route. Cardiac toxicity (myofiber 
degeneration and local inflammation) were also seen in a rat dermal 
toxicity study. Pyroxasulfone did not elicit immunotoxic effects in 
rats or mice. Neurotoxicity was seen in a developmental neurotoxicity 
study in offspring rats (decreased brain weight, decreased thickness of 
the hippocampus, corpus callosum and cerebellum). There is evidence of 
fetal and offspring quantitative susceptibility in the developmental 
neurotoxicity study in rats as effects occurred in the absence of 
maternal toxicity. There is no concern for reproductive toxicity.
    Pyroxasulfone is classified as ``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. The Agency 
has determined that the quantification of risk using a non-linear 
approach (i.e., reference dose (RfD)) will adequately account for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to pyroxasulfone.
    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 document titled, ``SUBJECT: Pyroxasulfone Human 
Health Risk Assessment for the Section 3 New Uses of Pyroxasulfone on 
Mint, Edamame (vegetable soybean), Grass (seed crop) for the Pacific 
Northwest only, Leaf Petiole Vegetable Subgroup 22B and Expansion of 
Cottonseed Subgroup 20C,'' at pages 34-79 in docket ID number EPA-HQ-
OPP-2017-0334.

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 discussed in Unit III of the final rule 
published in the Federal Register of May 17, 2018 (83 FR 22854) (FRL-
9977-25).

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 2003-2008 food consumption data from the 
United States Department of Agriculture's (USDA) 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 that are not in the 
tolerance expression, except for soybean and subgroup 22B commodities, 
for which EPA used anticipated residues from field trial data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance level residues that were adjusted for metabolites not in the 
tolerance expression, except for soybean and subgroup 22B commodities, 
for which EPA used anticipated residues from field trial data.
    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 PCT information in the dietary assessment for 
pyroxasulfone; 100% CT was assumed for all food commodities. Tolerance-
level residues were used for all commodities except soybean and 
subgroup 22B commodities, for which EPA used anticipated residues from 
field trial data.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.

[[Page 54262]]

    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 acute dietary risk 
assessment, the water concentration value of 210 ppb was used to assess 
the contribution to drinking water. For 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.
    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 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 website at 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. 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 (decreased brain weight 
and morphometric changes) were noted in offspring at 300 mg/kg/day in 
the rat developmental neurotoxicity (DNT) study compared to no maternal 
toxicity at 900 mg/kg/day. In a reproductive toxicity in rats, reduced 
pup weight and body weight gains during lactation occurred at similar 
or higher 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. The neurotoxicity database, including acute, subchronic and 
chronic studies, shows adverse effects from pyroxasulfone exposure in 
mice, rats and dogs, with the latter species showing greatest 
sensitivity. Although the DNT study 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 noted in Unit III.D.2., the available database shows 
evidence of increased susceptibility of fetuses and offspring in a DNT 
study in rats and in a developmental study in rabbits following in 
utero or post-natal exposure to pyroxasulfone. The Agency concludes, 
however, 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 in the exposure databases. 
The dietary food exposure assessments were performed based on 100 PCT 
and tolerance-level residues or residues based on field trials. 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 analysis, the risk estimate for acute dietary 
exposure from food and water to pyroxasulfone is at 3.7% of the aPAD 
for all infants less than 1 year old, the population group receiving 
the greatest exposure. The

[[Page 54263]]

acute dietary risk is not of concern (<100% aPAD).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure analysis, EPA has concluded that risk 
estimates for chronic exposure to pyroxasulfone from food and water are 
not of concern (<100% cPAD) with a risk estimate at 50% 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 
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: (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.
    The Codex has not established a MRL for residues of pyroxasulfone 
in or on any of the petitioned-for commodities associated with this 
regulatory action.

C. Response to Comments

    One anonymous public comment was received that expressed concerns 
about the cost of EPA regulations to tax payers and corporations. This 
comment did not raise any issue relevant to the Agency's safety 
determination for this tolerance action. Section 408 of the Federal 
Food, Drug and Cosmetic Act (FFDCA) allows EPA to set tolerances for 
residues of pesticide chemicals when it determines that the tolerance 
meets the safety standard imposed by that statute. EPA has made that 
determination for the pyroxasulfone tolerances established by this 
final rule.

D. Revisions to Petitioned-For Tolerances

    EPA calculated tolerance levels using the Organization for Economic 
Cooperation and Development (OECD) tolerance calculation procedures, 
available field trial residue data, and metabolite concentrations 
covered to parent equivalents. The Agency is also harmonizing with 
relevant Canadian MRLs. In addition, the Agency is using commodity 
terminology consistent with the terms generally used for tolerances.
    As a result, the Agency is establishing tolerances that differ from 
the petitioned-for tolerances as follows: (1) The proposed 
pyroxasulfone tolerances on both Peppermint, oil and Spearmint, oil at 
0.48 ppm are being established at 0.70 ppm; (2) the proposed 
pyroxasulfone tolerances on both Peppermint, fresh leaves and 
Spearmint, fresh leaves at 0.15 ppm are being each established at 0.20 
ppm; and (3) the proposed tolerance on Leaf petiole vegetable subgroup 
22B at 0.3 ppm is being established at 0.80 ppm.
    In addition, although the petitioner requested a tolerance on 
Soybean, vegetable, succulent at 0.2 ppm, this term is broad and covers 
two forms of vegetable soybean--Soybean, vegetable, succulent shelled, 
and Vegetable, soybean, edible podded; therefore, to conform to the 
Agency's commodity terminology for soybeans, the Agency is establishing 
the tolerance requested as separate tolerances at 0.40 ppm for both 
forms of succulent soybean vegetable.

V. Conclusion

    Therefore, tolerances are established for residues of 
pyroxasulfone, including its metabolites and degradates, in or on 
Cottonseed subgroup 20C at 0.04 ppm; Leaf petiole vegetable subgroup 
22B at 0.80 ppm; Peppermint, fresh leaves at 0.20 ppm; Peppermint, oil 
at 0.70 ppm; Soybean, vegetable, succulent shelled at 0.40 ppm; 
Spearmint, fresh leaves at 0.20 ppm; Spearmint, oil at 0.70 ppm; and 
Vegetable, soybean, edible podded at 0.40 ppm. In addition, tolerances 
with regional registrations are established in or on Grass, forage at 
0.50 ppm and Grass, hay 1.0 ppm. Lastly, the Agency is removing the 
existing pyroxasulfone tolerance on Cotton, undelinted seed that is 
superseded by this final rule.

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); or 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

[[Page 54264]]

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: October 9, 2018.
Michael L. 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.  180.659:
0
a. In the table in paragraph (a)(1):
0
i. Remove the entry ``Cotton, undelinted seed'';
0
ii. Add alphabetically the commodity, ''Cottonseed subgroup 20C'';
0
b. In the table in paragraph (a)(5), add alphabetically the 
commodities, ``Leaf petiole vegetable subgroup 22B''; ``Peppermint, 
fresh leaves''; ``Peppermint, oil''; ``Soybean, vegetable, succulent 
shelled''; ``Spearmint fresh leaves''; ``Spearmint, oil''; and 
``Vegetable, soybean, edible podded''; and
0
c. Revise paragraph (c).
    The additions and revisions read as follows:


Sec.  180.659   Pyroxasulfone; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cottonseed, subgroup 20C.....................................       0.04
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (5) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Leaf petiole vegetable subgroup 22B..........................       0.80
 
                                * * * * *
Peppermint, fresh leaves.....................................       0.20
Peppermint, oil..............................................       0.70
 
                                * * * * *
Soybean, vegetable, succulent shelled........................       0.40
Spearmint, fresh leaves......................................       0.20
Spearmint, oil...............................................       0.70
 
                                * * * * *
Vegetable, soybean, edible podded............................       0.40
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerance with regional registrations. 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 commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grass, forage................................................       0.50
Grass, hay...................................................        1.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-23002 Filed 10-26-18; 8:45 am]
 BILLING CODE 6560-50-P


