[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
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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: [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.
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
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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
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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:
[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 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
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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