Pethoxamid; Pesticide Tolerances, 48654-48659 [2020-16452]
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Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 / Rules and Regulations
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
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
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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.
Parts per
million
Commodity
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Rapeseed, seed .........................
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Vegetable, tuberous and corm,
crop subgroup 1C ...................
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[FR Doc. 2020–16456 Filed 8–11–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0510; FRL–10008–94]
Pethoxamid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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,
Dated: July 2, 2020.
Drug, and Cosmetic Act (FFDCA).
Michael Goodis,
DATES: This regulation is effective
August 12, 2020. Objections and
Director, Registration Division, Office of
Pesticide Programs.
requests for hearings must be received
Therefore, for the reasons stated in the on or before October 13, 2020 and must
be filed in accordance with the
preamble, the EPA amends 40 CFR
instructions provided in 40 CFR part
chapter I as follows:
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
ADDRESSES: The docket for this action,
CHEMICAL RESIDUES IN FOOD
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0510, is
■ 1. The authority citation for part 180
available at https://www.regulations.gov
continues to read as follows:
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
Authority: 21 U.S.C. 321(q), 346a and 371.
in the Environmental Protection Agency
■ 2. In § 180.350, amend paragraph (a)
Docket Center (EPA/DC), West William
by adding to the table, in alphabetical
Jefferson Clinton Bldg., Rm. 3334, 1301
order, the commodities, ‘‘Beet, sugar,
Constitution Ave. NW, Washington, DC
molasses’’, ‘‘Beet, sugar, roots’’, ‘‘Beet,
20460–0001. The Public Reading Room
sugar, tops’’, ‘‘Rapeseed, seed’’, and
is open from 8:30 a.m. to 4:30 p.m.,
‘‘Vegetable, tuberous and corm, crop
Monday through Friday, excluding legal
subgroup 1C’’ to read as follows:
holidays. The telephone number for the
§ 180.350 Nitrapyrin; tolerances for
Public Reading Room is (202) 566–1744,
residues.
and the telephone number for the OPP
Docket is (703) 305–5805.
(a) * * *
Please note that due to the public
Parts
per
health
emergency, the EPA Docket
Commodity
million
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
*
*
*
*
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Beet, sugar, molasses ................
0.5 continue to provide customer service
Beet, sugar, roots .......................
0.3 via email, phone, and webform. For
Beet, sugar, tops ........................
0.7 further information on EPA/DC services,
docket contact information and the
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SUMMARY:
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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:
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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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
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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, https://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.
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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-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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
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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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-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 tolerancelevel 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
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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
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-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 nonoccupational, 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 postapplication 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 postapplication 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 https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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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.
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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 postapplication 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
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48657
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 intermediateterm 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 multiresidue 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.
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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.
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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
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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).
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.710 to subpart C to read
as follows:
■
§ 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-chloroN-(2-ethoxyethyl)-N-(2-methyl-1phenyl-1-propen-1-yl) acetamide in or
on the commodity.
Commodity
48659
Parts per
million
Cattle, meat ................................
Cattle, meat byproducts .............
Corn, field, forage .......................
Corn, field, grain .........................
Corn, field, stover .......................
Corn, pop, grain ..........................
Corn, pop, stover ........................
Corn, sweet, forage ....................
Corn, sweet, kernel plus cob
with husk removed ..................
Corn, sweet, stover ....................
Cotton, gin byproducts ...............
Cotton, undelinted seed .............
Egg .............................................
Goat, fat ......................................
Goat, meat ..................................
Goat, meat byproducts ...............
Hog, fat .......................................
Hog, meat ...................................
Hog, meat byproducts ................
Horse, fat ....................................
Horse, meat ................................
Horse, meat byproducts .............
Milk .............................................
Poultry, fat ..................................
Poultry, meat ..............................
Poultry, meat byproducts ............
Sheep, fat ...................................
Sheep, meat ...............................
Sheep, meat byproducts ............
Soybean, forage .........................
Soybean, hay ..............................
Soybean, seed ............................
List of Subjects in 40 CFR Part 180
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
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Commodity
Cattle, fat ....................................
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(b) [Reserved]
[FR Doc. 2020–16452 Filed 8–11–20; 8:45 am]
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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: RDFRNoti[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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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
[[Page 48656]]
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 https://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 https://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 https://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 https://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 https://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:
[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
[[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
