Document ID: EPA-HQ-OPP-2015-0787-0026
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pyroxasulfone
Posted Date: 2018-05-17T04:00Z

[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22854-22859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10582]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0787; FRL-9977-25]

Pyroxasulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyroxasulfone and its metabolites in or on vegetable, tuberous and 
corm, subgroup 1C; vegetable, bulb, group 3-07; and potatoes, granules/
flakes. K-I Chemical USA, Inc. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 17, 2018. Objections and 
requests for hearings must be received on or before July 16, 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-2015-0787, 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.

[[Page 22855]]

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-2015-0787 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 
July 16, 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-2015-0787, 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 January 26, 2018 (83 FR 3659) (FRL-9971-
46), 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 
5F8521) by K-I Chemical USA, Inc., 11 Martine Ave., Suite 970, White 
Plains, NY 10606. The petition requested that 40 CFR part 180.659 be 
amended by establishing tolerances for residues of the herbicide 
pyroxasulfone, (3-[5-(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)pyrazol-4-yl methylsulfonyl]-4,5-dihydro-5,5-dimethyl-
1,2-oxazole) in or on Crop Subgroup 1C, tuberous and corm vegetables 
(except granular/flakes and chips) at 0.05 parts per million (ppm); 
Crop Subgroup 3-07, bulb vegetables at 0.15 ppm; potatoes, granular/
flakes at 0.3 ppm; and potato chips at 0.06 ppm. That document 
referenced a summary of the petition prepared by K-I Chemical USA, 
Inc., the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the 
notice of filing.
    Because the January 26, 2018, document identified the K-I Chemical 
petition by the wrong petition number, EPA published another document 
in the Federal Register assigning the correct petition number to the K-
I Chemical petition--PP6F8521. That document was published in the 
Federal Register on March 15, 2018 (83 FR 11448) (FRL-9974-72). No 
relevant comments were received on the notice of filing.
    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.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 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.
    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. 
Minimal to mild cardiac myofiber degeneration and local inflammation 
were also seen in a rat dermal toxicity study. Neurotoxicity was also 
seen in a developmental neurotoxicity study in rats (decreased brain 
weight, decreased thickness of the hippocampus, corpus callosum and 
cerebellum in offspring). Dogs appear to be the most sensitive species 
to the neurotoxic effects of pyroxasulfone. Immunotoxicity studies in 
rats and mice show no evidence of immunotoxic effects from 
pyroxasulfone.
    There is evidence of fetal and offspring 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

[[Page 22856]]

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 the no-observed-adverse 
effect level (NOAEL) and lowest-observed adverse effect level (LOAEL) 
from the toxicity studies can be found at http://www.regulations.gov in 
document ``Pyroxasulfone Human Health Risk Assessment for the Section 3 
New Uses of Pyroxasulfone on Crop Subgroup 1C, tuberous and corm 
vegetables and Crop Group 3-07, bulb vegetables'' at pages 39-53 in 
docket ID number EPA-HQ-OPP-2015-0787.

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 the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a 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 use https://www.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 the Table 1 of this unit.

  Table 1--Toxicological Doses and Endpoints for Pyroxasulfone for Use in Dietary Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                      Point of      Uncertainty/ FQPA                            Study and
       Exposure/scenario             departure        safety factors       RfD & PAD       toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General           NOAEL= 100 mg/kg.  UFA= 10x.........  Acute RfD = 1.0    Developmental
 Population, including Infants                      UFH=10x..........   mg/kg.             neurotoxicity study
 and Children).                                     FQPA SF=1x.......  aPAD = 1.0 mg/kg.   (DNT) in rats.
                                                                                          The LOAEL of 300 mg/kg/
                                                                                           day is based on
                                                                                           decreased brain
                                                                                           weight in both sexes,
                                                                                           reduced thickness of
                                                                                           the hippocampus,
                                                                                           corpus callosum and
                                                                                           cerebellum in
                                                                                           postnatal day (PND)
                                                                                           21 female offspring.
Chronic Dietary (All             NOAEL= 2 mg/kg/    UFA= 10x.........  Chronic RfD =      One- year chronic dog
 Populations).                    day.              UFH=10x..........   0.02 mg/kg/day.    study
                                                    FQPA SF=1x.......  cPAD = 0.02 mg/kg/ The LOAEL of 10 mg/kg/
                                                                        day.               day is based on
                                                                                           impaired hind limb
                                                                                           function, 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 (all routes)............  ``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.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

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 data from the United States 
Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination 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 the USDA 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 
classified pyroxasulfone 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., RfD) will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to pyroxasulfone.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and PCT information in the dietary 
assessment for pyroxasulfone. Tolerance-level residues and 100% crop 
treated (CT) 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

[[Page 22857]]

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 at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides.
    Based on the Pesticide Root Zone Model Ground Water (PRZM version 
3.122)/Exposure Analysis Modeling System-Superseded (EXAMS version 
2.98.04), the estimated concentrations of pyroxasulfone in surface 
water were minimal, and the highest estimated drinking water 
concentrations (EDWCs) of pyroxasulfone residues were from a Tier II 
PRZM-GW modeling at an application rate of 0.267 lbs active ingredient/
Acre for registered crops. The same EDWCs have been used for the 
current human health dietary risk assessment. The EDWCs for peak 
concentration (used in the acute assessment) and 30-year average 
concentration (used in the chronic assessment) were 0.210 and 0.174 mg/
L (ppm), respectively. Water residues were incorporated in the Dietary 
Exposure Evaluation Model--Food Commodity Intake Database (DEEM-FCID) 
into the food categories ``water, direct, all sources'' and ``water, 
indirect, all sources.''
    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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides.

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 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 offspring 
at 300 mg/kg/day in the rat 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 DNT study. 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. Evidence of increased susceptibility of fetuses and offspring 
was seen in a DNT study in rats and a developmental study in rabbits 
following in utero or post-natal exposure to pyroxasulfone. However, no 
susceptibility was seen in the rat developmental or reproduction 
studies. 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. This increased susceptibility is occurring 
at high doses. NOAELs and LOAELs have been identified for all effects 
of concern and thus, a clear dose response has been well defined. 
Therefore, residual uncertainties or concerns for pre- and/or post-
natal toxicity are minimal, and EPA concludes that reducing the FQPA 
safety factor to 1X will be protective of such effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT 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 population adjusted dose (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

[[Page 22858]]

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 50% of the cPAD for all 
infants less than 1-year old, the population group receiving the 
greatest exposure.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Although short-term and intermediate-term adverse effects were 
identified, pyroxasulfone is not registered for any use patterns that 
would result in residential exposure. Therefore, EPA relies on the 
chronic dietary risk assessment for evaluating short-term 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) methods) 
are available to enforce the tolerance expression.
    These methods 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 pyroxasulfone in any of the proposed commodities.

C. Revisions to Petitioned-For Tolerances

    The vegetable, tuberous and corm, subgroup 1C tolerance is being 
established at 0.08 ppm instead of 0.05 ppm. The petitioner's requested 
tolerance level included only residues from the parent and M1 
metabolite. The Agency is establishing this tolerance at 0.08 ppm to 
account for the measurement of parent and four metabolites. Applying 
processing factors in accordance with the Agency's policy for 
determining such factors when measuring multiple pesticide residues, 
the Agency has determined that 0.20 ppm is an appropriate tolerance 
level for granules/flakes. In addition, The Agency has determined that 
a tolerance for potato chips is not required because residues will be 
within the tolerance level established for subgroup 1C.

V. Conclusion

    Therefore, tolerances are established for residues of pyroxasulfone 
including its metabolites and degradates, in or on potatoes, granules/
flakes at 0.20 ppm; vegetable, bulb, group 3-07 at 0.15 ppm; and 
vegetable, tuberous and corm, subgroup 1C at 0.08 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); 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 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).

[[Page 22859]]

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: May 8, 2018.
Daniel Rosenblatt,
Acting 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, add alphabetically ``Potato, granules/flakes'', 
``Vegetable, bulb, group 3-07'', and ``Vegetable, tuberous and corm, 
subgroup 1C'' to the table in paragraph (a)(5) to read as follows:

Sec.  180.659  Pyroxasulfone; tolerances for residues.

    (a) * * *
    (5) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato, granules/flakes.....................................        0.20
 
                                * * * * *
Vegetable, bulb, group 3-07.................................        0.15
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................        0.08
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-10582 Filed 5-16-18; 8:45 am]
 BILLING CODE 6560-50-P