Document ID: EPA-HQ-OPP-2017-0510-0044
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pethoxamid
Posted Date: 2020-08-12T04:00Z

[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Rules and Regulations]
[Pages 48654-48659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16452]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0510; FRL-10008-94]

Pethoxamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective August 12, 2020. Objections and 
requests for hearings must be received on or before October 13, 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-2017-0510, 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 note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the

[[Page 48655]]

current status of the EPA/DC and Reading Room, please visit https://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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0510 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 
October 13, 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-2017-0510, 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 April 11, 2018 (83 FR 15528) (FRL-9975-
57), 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 
7F8572) by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. 
The petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the herbicide pethoxamid in or on corn, 
field, forage at 0.015 parts per million (ppm); corn, field, stover at 
0.02 ppm; corn, field, grain at 0.01 ppm; popcorn, stover at 0.01 ppm; 
popcorn, grain at 0.01 ppm; corn, sweet, forage at 0.50 ppm; corn, 
sweet, stover at 0.60 ppm; corn, sweet, kernel plus cob with husk 
removed at 0.01 ppm; cotton, undelinted seed at 0.01 ppm; cotton, gin 
byproducts at 0.09 ppm; soybean, forage at 3.0 ppm; soybean, hay at 4.5 
ppm; and soybean, seed at 0.01 ppm.
    In the Federal Register of October 28, 2019 (84 FR 57685) (FRL-
10001-11), 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 
7F8572) by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. 
The petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the herbicide pethoxamid in or on cattle, 
fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 
0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, forage at 0.015 
ppm; corn, field, stover at 0.02 ppm; corn, sweet, kernel plus cob with 
husk removed at 0.01 ppm; corn, sweet, stover at 0.60 ppm; cotton, gin 
byproducts at 0.09 ppm; cotton, undelinted seed at 0.01 ppm; egg at 
0.01 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat 
byproducts at 0.01 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; 
hog, meat byproducts at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat 
at 0.01 ppm; horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; 
popcorn, grain at 0.01 ppm; popcorn, stover at 0.01 ppm; poultry, fat 
at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, meat byproducts at 
0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat 
byproducts at 0.01 ppm; soybean, forage at 3.0 ppm; soybean, hay at 4.5 
ppm; and soybean, seed at 0.01 ppm. The October 28, 2019 Notice of 
Filing (NOF) supersedes the April 11, 2018 NOF. The documents 
referenced a summary of the petition prepared by FMC Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov.
    Comments were received on the notice of filing. EPA's response to 
these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what was requested. The reason 
for these changes is 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

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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 pethoxamid including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with pethoxamid 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 hazard database for pethoxamid indicates that the primary 
effects occur in the liver and thyroid, including increased changes in 
thyroid weight, thyroid hypertrophy, thyroid hyperplasia, thyroid 
follicular cell adenomas, and benign hepatocellular adenomas in mice. 
Potential signs of neurotoxicity occurring at very high doses were 
considered agonal, rather than adverse. Reproductive toxicity was not 
observed, and developmental/offspring toxicity was limited to decreased 
fetal body weights and late abortions. Specific information on the 
studies received and the nature of the adverse effects caused by 
pethoxamid 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 
titled, ``Pethoxamid: Human Health Risk Assessment for Proposed Section 
3 Registration of the New Active Ingredient on Corn, Cotton, and 
Soybeans and in/on Turf and Ornamental Sites'' (hereinafter 
``Pethoxamid Human Health Risk Assessment'') on pages 43-52 in docket 
ID number EPA-HQ-OPP-2017-0510.

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 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-pesticide.
    A summary of the toxicological endpoints for permethrin used for 
human risk assessment can be found in the Pethoxamid Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pethoxamid, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pethoxamid 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 
pethoxamid; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used 2003-2008 food consumption information from the 
United States Department of Agriculture's (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, the chronic analysis assumed tolerance-
level residues, default processing factors and 100 percent crop treated 
(PCT) estimates.
    iii. Cancer. Based on the Agency's analysis of the available data, 
EPA has concluded that a nonlinear RfD approach is appropriate for 
assessing cancer risk to pethoxamid. Quantification of cancer risk 
using a non-linear RfD approach will adequately account for all chronic 
toxicity, including carcinogenicity that could result from exposure to 
pethoxamid; therefore, a separate cancer dietary assessment was not 
conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
pethoxamid. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for pethoxamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pethoxamid. 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.
    Using the Pesticides in Water Calculator (PWC) and Pesticide Root 
Zone Model and the Varying Volume Water Model (PRZM/VVWM) models, EPA 
calculated the estimated drinking water concentrations (EDWCs) of 
pethoxamid for chronic exposures in surface and ground water. EPA used 
the modeled EDWCs directly in the dietary exposure model to account for 
the contribution of pethoxamid residues in drinking water as follows: 
7.45 ppb was used in the chronic assessment.
    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).
    Pethoxamid is proposed to be registered for the following uses that 
could result in residential exposures: Residential lawns and golf 
courses. EPA assessed residential exposure using the following 
assumptions: Because labels will include language stating that these 
products are to be applied by professional applicators only, 
residential handler exposures are not expected.
    There is the potential for short-term post-application exposure for 
individuals exposed as a result of being in an environment that has 
been previously treated with pethoxamid. The quantitative exposure/risk 
assessment for residential post-application exposures is based on the 
following scenarios: Incidental oral (hand-to-mouth, object-to-mouth, 
and soil ingestion) following a broadcast turf application. Neither an 
adult nor child dermal assessment was conducted because a dermal 
endpoint was not

[[Page 48657]]

selected. While not the only life stage potentially exposed for these 
post-application scenarios, the life stage that is included in the 
quantitative assessment (child 1 to less than 2 years old) is health 
protective for the exposures and risk estimates for any other 
potentially exposed life stage.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pethoxamid and any other 
substances, and pethoxamid does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that pethoxamid has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Pethoxamid did not cause 
reproductive toxicity in rats. Developmental/offspring toxicity in rats 
was limited to decreased body weight and was observed at the same doses 
that caused maternal/parental toxicity. Developmental toxicity in 
rabbits was limited to decreased fetal body weights and late abortions 
observed at the same doses that caused maternal toxicity (late 
abortions, clinical signs, decreased body weight, and red substance on 
fur/in the cage).
    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 pethoxamid is complete.
    ii. There is evidence of potential neurotoxicity in the pethoxamid 
database in the acute neurotoxicity study and in the developmental 
toxicity study in rats. However, concern is low because: (1) The 
observed effects are well characterized, with clear NOAELs; (2) they 
occur only at the highest doses tested and are likely agonal in nature; 
and (3) PODs are based on the most sensitive effects and are protective 
of any potential neurotoxicity.
    iii. There is no evidence that pethoxamid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pethoxamid in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
pethoxamid.

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. 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, 
pethoxamid 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 
pethoxamid from food and water will utilize less than 1% of the cPAD 
for children 1 to 2 years old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
pethoxamid is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Pethoxamid is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to pethoxamid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 720 for 
children 1 to less than 2 years old. Because EPA's level of concern for 
pethoxamid is a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
pethoxamid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the

[[Page 48658]]

chronic dietary risk assessment for evaluating intermediate-term risk 
for pethoxamid.
    5. Aggregate cancer risk for U.S. population. Based on the Agency's 
chronic risk assessment, EPA does not expect cancer risk to result from 
aggregate exposure to pethoxamid.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pethoxamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a multi-residue method (quick, easy, 
cheap, effective, rugged and safe; QuEChERS; Method No. AGR/MOA/PTX-8) 
for the determination of pethoxamid in plant commodities. Method EAS 
Study Code S15-03519 is proposed as the enforcement method for 
determination of residues of pethoxamid in livestock commodities. The 
extraction and analysis procedures are based on the QuEChERS method and 
are very similar to those of the proposed enforcement method for crop 
commodities, EAS Method No. AGR/MOA/PTX-8.
    The 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for pethoxamid.

C. Response to Comments

    Two comments were received in response to the April 11, 2018 NOF, 
and 21 comments were received in response to the October 28, 2019 NOF. 
One comment was in support of the petition. One raised concern about 
bats and wind turbines that is unrelated to pesticides and this 
petition. The other comments were generally opposed to the Agency 
approving the use of pesticides on food, many stating that ``there are 
NO acceptable levels of pesticide residues in foods.'' Although the 
Agency recognizes that some individuals believe that pesticides should 
be banned on agricultural crops, the existing legal framework provided 
by section 408 of the FFDCA authorizes EPA to establish tolerances when 
it determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that these pethoxamid tolerances are safe. The commenters have provided 
no information to indicate that pethoxamid is not safe.

D. Revisions to Petitioned-For Tolerances

    The following tolerances are being set at 0.01 ppm because crop 
field trials indicated that residues of pethoxamid were below the limit 
of quantitation (<0.01 ppm) in/on all soybean, cotton and corn 
commodities: Corn, field forage; corn, field stover; corn, sweet, 
forage; corn, sweet, stover; cotton gin byproducts; soybean, forage; 
and soybean, hay.

V. Conclusion

    Therefore, tolerances are established for residues of pethoxamid, 
including its metabolites and degradates, in or on cattle, fat at 0.01 
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; 
corn, field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, 
field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, 
stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, 
kernel plus cob with husk removed at 0.01 ppm; corn, sweet, stover at 
0.01 ppm; cotton, gin byproducts at 0.01 ppm; cotton, undelinted seed 
at 0.01 ppm; egg at 0.01 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 
ppm; goat, meat byproducts at 0.01 ppm; hog, fat at 0.01 ppm; hog, meat 
at 0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, fat at 0.01 ppm; 
horse, meat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; milk at 
0.01 ppm; poultry, fat at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, 
meat byproducts at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 
0.01 ppm; sheep, meat byproducts at 0.01 ppm; soybean, forage at 0.01 
ppm; soybean, hay at 0.01 ppm; and soybean, seed at 0.01 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances 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

[[Page 48659]]

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: June 26, 2020.
Michael Goodis,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends 
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.

0
2. Add Sec.  180.710 to subpart C to read as follows:

Sec.  180.710  Pethoxamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pethoxamid, 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 
pethoxamid, 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenyl-1-propen-1-
yl) acetamide in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.01
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husk removed..............        0.01
Corn, sweet, stover.........................................        0.01
Cotton, gin byproducts......................................        0.01
Cotton, undelinted seed.....................................        0.01
Egg.........................................................        0.01
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.01
Hog, fat....................................................        0.01
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.01
Milk........................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.01
Soybean, forage.............................................        0.01
Soybean, hay................................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (b) [Reserved]

[FR Doc. 2020-16452 Filed 8-11-20; 8:45 am]
BILLING CODE 6560-50-P