[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Rules and Regulations]
[Pages 55380-55385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19673]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0413; FRL-10013-02]


Tiafenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tiafenacil in or on multiple commodities which are identified and 
discussed later in this document. ISK Biosciences Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective September 8, 2020. Objections and 
requests for hearings must be received on or before November 9, 2020, 
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-2019-0413, 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. Due to the public health concerns related to 
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to 
visitors with limited exceptions. The staff continues to provide remote 
customer service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW,

[[Page 55381]]

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 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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-2019-0413 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 9, 2020. 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-2019-0413, 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/where-send-comments-epa-dockets.
    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 August 30, 2019 (84 FR 45702) (FRL-9998-
15), 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 
8F8676) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A., 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide 
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, including its metabolites and degradates, in or on 
corn, which includes field corn and popcorn, at 0.01 parts per million 
(ppm); cottonseed subgroup 20C, gin byproducts at 3.0 ppm; cottonseed 
subgroup 20C, undelinted seed at 0.5 ppm; grape at 0.01 ppm; grape, 
raisin at 0.01 ppm; soybean seed at 0.01 ppm; and wheat grain at 0.01 
ppm. That document referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance expressions, revised tolerance values and 
definitions for some commodities, and established tolerances on 
livestock feed commodities. 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 tiafenacil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tiafenacil 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 available data indicate that exposure to tiafenacil caused 
consistent decreases in absolute body weights, alterations in the 
erythropoietic system, minor clinical chemical changes, and 
histopathological changes in the liver, bone marrow and the spleen of 
mice, rats and dogs. There was no evidence of carcinogenicity, 
genotoxicity, mutagenicity, dermal toxicity, neurotoxicity, or 
immunotoxicity.
    There was evidence of an increased fetal quantitative 
susceptibility in rats

[[Page 55382]]

but not rabbits. In rats, no maternal effects were observed up to the 
highest dose tested, while there was a decrease in fetal weights at the 
high dose. The decrease in fetal body weights is not considered a 
single dose effect. No adverse effects were observed in rabbits in 
maternal or fetal animals. There was no evidence of increased postnatal 
susceptibility in the 2-generation reproductive study up to the highest 
dose tested. Increased levels of porphyrin were observed in the liver 
at the highest doses tested in parents and offspring. While not 
adverse, this effect is consistent with the hematotoxicity observed 
throughout the database at higher doses. At the highest dose in the 1-
generation reproductive study, parental effects included pale skin, 
decreased body weight and food consumption, low hemoglobin 
concentrations, hematocrit, mean corpuscular volume, and mean 
corpuscular hemoglobin and platelet count. F1 offspring were not 
generated based upon the effects in adults as it was predicted that 
similar effects and increased mortality would occur.
    Tiafenacil has low acute lethality through oral, dermal, and 
inhalation routes. It is not an ocular or dermal irritant, nor is it a 
dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by tiafenacil 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, ``Tiafenacil. Human Health Risk 
Assessment for the Section 3 Registration Action of the New Active 
Ingredient on Grapes, Corn, Cotton, Soybeans, and Wheat''. First Food 
Use. in docket ID number EPA-HQ-OPP-2019-0413.

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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    The toxicological endpoints used to assess safety of exposures to 
tiafenacil are discussed in the Human Health Risk Assessment mentioned 
above.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tiafenacil, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from tiafenacil 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. No such effects were 
identified in the toxicological studies for tiafenacil; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the United States 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA assumed 100% CT and tolerance-level 
residues for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that tiafenacil does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for tiafenacil. Tolerance level residues and/or 100% 
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 tiafenacil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tiafenacil. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Modeled estimates of drinking water concentrations based on the 
Pesticides in Water Calculator (PWC) version 1.52 were directly entered 
into the dietary exposure model. For chronic dietary risk assessment, 
the highest estimated drinking water concentration of 66 parts per 
billion was used to assess the contribution to drinking water from 
groundwater 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). There are no uses for 
tiafenacil that will 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 tiafenacil to share a common mechanism of 
toxicity with any other substances, and tiafenacil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tiafenacil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.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

[[Page 55383]]

completeness of the database on toxicity and exposure unless EPA 
determines based on reliable data that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the FQPA Safety Factor (SF). In applying 
this provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence from a rat 
developmental study of an increased quantitative fetal susceptibility 
following in utero exposure to tiafenacil in rats. Although a 2-
generation reproductive study would typically further characterize this 
susceptibility, no effects were observed in parents and offspring in 
the definitive study. Therefore, EPA conducted a weight-of-evidence 
(WOE) analysis taking into consideration a 1-generation reproductive 
study and determined that the concern for the observed effects is low 
because: (1) The effects are well characterized and clear NOAELs were 
established; (2) the PODs selected for risk assessment are protective 
for the effects observed in the rat developmental and 1-generation 
reproductive studies; (3) the 2-generation reproductive study and the 
1-generation reproductive study are considered co-critical based upon 
similar doses allowing them to be considered together; (4) the parental 
effects were observed in the 1-generation reproductive study are six to 
seven-fold higher than the NOAEL; (5) increased porphyrin levels which 
are thought to be a precursor to hematotoxicity occur at the same dose 
in parental animals and offspring in the 2-generation reproductive 
study and not the lower two doses; and (6) quantitative susceptibility 
was not observed in the two-generation reproductive study for a similar 
chemical saflufenacil.
    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 tiafenacil is complete.
    ii. There is no indication that tiafenacil is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. The selected endpoints are protective of the observed 
increased fetal and offspring susceptibilities in rats. They are also 
protective of potential offspring effects which are expected to occur 
at the same dose as parental effects or higher.
    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 tiafenacil in drinking water. These assessments 
will not underestimate the exposure and risks posed by tiafenacil.

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. There are no residential uses for tiafenacil.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
tiafenacil is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tiafenacil from food and water will utilize 14% of the cPAD for the 
general population, and 36% of the cPAD for infants (<1 year old), the 
population group receiving the greatest exposure.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate exposures takes into account short- and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Because there are no 
residential uses for tiafenacil, short- and intermediate-term aggregate 
exposures are equivalent to the chronic dietary exposure.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tiafenacil 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 tiafenacil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography method with tandem mass spectrometry detection (LC/MS/
MS), Method No. GPL-MTH-113) is available to enforce the tolerance 
expression for determination of residues of tiafenacil and metabolites 
M-36 (2-(2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-
2,3-dihydropyrimidin-1(6H)-yl)phenylsulfinyl)propanoic acid) and M-56 
(2-(2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-
1(6H)-yl)-4-fluorophenylsulfinyl)propanoic acid) in crop commodities.
    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 any MRL for tiafenacil.

C. Revisions to Petitioned-for Tolerances

    Based upon review of supporting residue data, EPA has made several 
modifications to the petition. The petitioner did not propose 
tolerances for residues in or on the livestock feed raw agricultural 
commodities (RACs) associated with the use of tiafenacil on corn, 
wheat, and soybeans; however, EPA has determined that tolerances for

[[Page 55384]]

residues in these RACs are needed based on the tolerances requested, as 
the crop field trial data showed quantifiable residues of tiafenacil 
and its metabolites. For livestock feed items (both preplant and 
desiccation), significant amounts of metabolites M-01, M-10, M-52, M-
53, M-36, and/or M-56 were found in the corn, cotton, soybean, and 
wheat field trials. For tolerance enforcement in livestock feed items, 
tiafenacil, M-36, and M-56 are appropriate marker compounds as the 
metabolites are common to these RACs following preplant use and 
tiafenacil is the major residue following desiccation treatment. 
Therefore, EPA is establishing a separate tolerance expression for 
livestock feed RACs by including the sum of tiafenacil, M-36, and M-56 
for compliance with the tolerance values specified. In addition to 
establishing the petitioned-for tolerance on cotton gin byproducts 
under this separate tolerance expression, EPA also established 
tolerances on livestock RACs for corn (field, forage and stover; pop, 
stover), soybean (forage and hay), and wheat (forage, hay, straw). The 
tolerance values for cottonseed subgroup 20C undelinted seed and 
cottonseed subgroup 20C gin byproducts were corrected by removing the 
trailing zero to be consistent with EPA's Rounding Class Practice and 
the commodity definitions were revised to be consistent with Agency 
practice. All livestock feed RAC tolerance values were calculated using 
the Organization for Economic Co-operation and Development's (OECD) MRL 
calculation procedures.
    The proposed tolerance expression was revised for primary crops by 
removing the metabolite M-01 (3-(2-(2-chloro-4-fluoro-5-(3-methyl-2,6-
dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-
yl)phenylthio)propanamido)propanoic acid), as parent tiafenacil was the 
predominant residue and is thus the residue of concern for tolerance 
enforcement purposes. Residues in these human consumption commodities 
(seeds, grains, and fruits) will result only from desiccation use.
    A lower tolerance value was established for the cottonseed subgroup 
20C after adjusting the residue levels using proportionality to account 
for the exaggerated rate used in the cotton field trials and using the 
OECD MRL calculation procedures. The submitted processing studies 
indicate that a tolerance for residues of tiafenacil is not required 
for grape, raisin (i.e., no concentration of residues was observed).

V. Conclusion

    Therefore, tolerances are established for residues of tiafenacil, 
methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, including its metabolites and degradates, in or on 
Corn, field, forage at 0.05 ppm; Corn, field, grain at 0.01 ppm; Corn, 
field, stover at 0.05 ppm; Corn, pop, grain at 0.01 ppm; Corn, pop, 
stover at 0.05 ppm; Cotton, gin byproducts at 3 ppm; Cottonseed 
subgroup 20C at 0.3 ppm; Grape at 0.01 ppm; Soybean, forage at 0.15 
ppm; Soybean, hay at 0.3 ppm; Soybean, seed at 0.01 ppm; Wheat, forage 
at 0.05 ppm; Wheat, grain at 0.01 ppm; Wheat, hay at 0.08 ppm; and 
Wheat, straw at 0.07 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), 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).

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: August 23, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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

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


[[Page 55385]]



0
2. Add Sec.  180.713 to subpart C to read as follows:


Sec.  180.713   Tiafenacil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide tiafenacil, 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 
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, in or on the following commodities:

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, grain..........................................        0.01
Corn, pop, grain............................................        0.01
Cottonseed subgroup 20C.....................................         0.3
Grape.......................................................        0.01
Soybean, seed...............................................        0.01
Wheat, grain................................................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
tiafenacil, 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 
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate and its metabolites 2-(2-chloro-4-fluoro-5-(3-methyl-
2,6-dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-
yl)phenylsulfinyl)propanoic acid and 2-(2-chloro-5-(2,6-dioxo-4-
(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-yl)-4-
fluorophenylsulfinyl)propanoic acid, calculated as the stoichiometric 
equivalent of tiafenacil, in or on the following commodities:

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................           3
Corn, field, forage.........................................        0.05
Corn, field, stover.........................................        0.05
Corn, pop, stover...........................................        0.05
Soybean, forage.............................................        0.15
Soybean, hay................................................         0.3
Wheat, forage...............................................        0.05
Wheat, hay..................................................        0.08
Wheat, straw................................................        0.07
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2020-19673 Filed 9-4-20; 8:45 am]
BILLING CODE 6560-50-P