Rule2024-28080
Fatty acids, C16-18 and C18-unsatd., esters With polyethylene glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 2, 2024
Effective
December 2, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant and related adjuvant of surfactant) on growing crops and raw agricultural commodities pre- and post-harvest limited to 25% by weight in pesticide formulations. Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of fatty acids, C<INF>16-18</INF> and C<INF>18</INF>- unsatd., esters with polyethylene glycol mono-Me ether, when used in accordance with the terms of this exemption.
Full Text
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<title>Federal Register, Volume 89 Issue 231 (Monday, December 2, 2024)</title>
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[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Rules and Regulations]
[Pages 95131-95136]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28080]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0368; FRL-12393-01-OCSPP]
Fatty acids, C16-18 and C18-unsatd., esters With polyethylene
glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
(CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant
and related adjuvant of surfactant) on growing crops and raw
agricultural commodities pre- and post-harvest limited to 25% by weight
in pesticide formulations. Spring Regulatory
[[Page 95132]]
Sciences on behalf of Sasol Chemicals (USA) LLC submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-
unsatd., esters with polyethylene glycol mono-Me ether, when used in
accordance with the terms of this exemption.
DATES: This regulation is effective December 2, 2024. Objections and
requests for hearings must be received on or before January 31, 2025
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-2023-0368, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 and the OPP docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505T), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#f0a2b4b6a2be9f8499939583b0958091de979f86"><span class="__cf_email__" data-cfemail="5a081e1c0814352e33393f291a3f2a3b743d352c">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 40 CFR
part 180 through the Federal Register Office's e-CFR site at <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2023-0368 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
January 31, 2025. 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-2023-0368, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of September 19, 2023 (88 FR 64398, FRL-
10579-08), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11755) by Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250,
Spring, TX 77379) on behalf of Sasol Chemicals (USA) LLC (12120
Wickchester Lane, Houston, TX 77224). The petition requested that 40
CFR 180.910 be amended by establishing an exemption from the
requirement of a tolerance for residues of fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert
ingredient (surfactant and related adjuvant of surfactant) in pesticide
formulations applied to growing crops or raw agricultural commodities
pre- and post-harvest limited to 25% by weight in pesticide
formulations. That document referenced a summary of the petition
prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals
(USA) LLC, the petitioner, which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA
[[Page 95133]]
determines that the tolerance is ``safe.'' Section 408(c)(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. FFDCA section 408(c)(2)(B)
directs EPA to take into account the considerations in section
408(b)(2)(C) and (D) when making a safety determination for an
exemption from the requirement of a tolerance. 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 . . . '' Section 408(b)(2)(D) lists other
factors for EPA consideration when making safety determinations,
including the validity, completeness, and reliability of available
data, nature of toxic effects, available information concerning the
cumulative effects of the pesticide chemical and other substances with
a common mechanism of toxicity, and available information concerning
aggregate exposure levels to the pesticide chemical and other related
substances.
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 fatty acids, C<INF>16-18</INF>
and C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me
ether, including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
The toxicological database of fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
is supported by data regarding methyl laurate and alcohol ethoxylates
(C<INF>12</INF>AE<INF>7</INF>, C<INF>13</INF>AE<INF>3</INF>,
C<INF>14</INF>AE<INF>3</INF>, C<INF>14</INF>AE<INF>7</INF>,
C<INF>14</INF>AE<INF>12</INF>, C<INF>15</INF>AE<INF>3</INF> and
C<INF>15</INF>AE<INF>7</INF>). EPA has determined that it is
appropriate to bridge methyl laurate and the aforementioned alcohol
ethoxylates data to assess fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
based on similarities in the functional groups/structure, composition,
and physical/chemical properties.
Fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters
with polyethylene glycol mono-Me exhibits low levels of acute toxicity
via the oral, dermal, and inhalation routes of exposure. It is not a
skin irritant or a skin sensitizer, but it is minimally irritating to
the eyes. Reduced body weight starting at 250 mg/kg/day was observed in
the combined reproduction and developmental toxicity test, 2-generation
reproduction toxicity, and chronic/carcinogenicity studies. Increased
offspring susceptibility was observed in the two-generation
reproduction toxicity study in rats. Reduced body weight in pups was
observed at 250 mg/kg/day in the absence of maternal toxicity. However,
the concern for offspring susceptibility is low because the established
chronic reference dose (cRfD, 1.6 mg/kg/day) will be protective of
offspring effects observed at 250 mg/kg/day. No effects on reproductive
parameters, neurotoxicity or immunotoxicity were observed in the
available studies. Concern for carcinogenicity is low, based on no
evidence of tumors or cancer in chronic/carcinogenicity studies and
negative results in mutagenicity studies.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
An acute dietary endpoint was not selected because no effect
attributable to a single dose was identified in the database. Co-
critical chronic/carcinogenicity studies in rats were selected for the
chronic dietary exposure scenario as well as short- and intermediate-
term incidental oral, dermal and inhalation exposure scenarios. The
NOAEL of 160 mg/kg/day and LOAEL of 250 mg/kg/day, based on decreased
body weight, are selected for risk assessment. The studies are
appropriate for the duration of exposure, protective of all subchronic
effects, protective of the general population, and are protective of
the most sensitive lifestage (children). The standard inter- and intra-
species
[[Page 95134]]
uncertainty factors of 10x are applied (total uncertainty factor =
100x). A dermal absorption factor of 20% is applied. The default factor
of 100% is applied for the inhalation absorption rate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd.,
esters with polyethylene glycol mono-Me ether, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. There
are no known non-pesticidal dietary exposures for fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether. EPA assessed dietary exposures from fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether in food as follows:
In conducting the dietary exposure assessment using the Dietary
Exposure Evaluation Model DEEM--FCIDTM, Version 4.02, EPA used food
consumption information from the U.S. Department of Agriculture's
(USDA's) 2005-2010 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether.
In the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
titled ``Update to D361707: Dietary Exposure and Risk Assessments for
the Inerts.'' (12/21/2021) and can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPP-2018-0090.
In the dietary exposure assessments, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of fatty acids, C<INF>16-18</INF>
and C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me
ether, EPA made a specific adjustment to the dietary exposure
assessment to account for the use limitations of the amount of fatty
acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether that may be in pesticide formulations
(limited to no more than 25%) present at the maximum limitation rather
than at equal quantities with the active ingredient.
For the purpose of the screening level dietary risk assessment, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters
with polyethylene glycol mono-Me ether.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters
with polyethylene glycol mono-Me ether may be used as an inert
ingredient in pesticide products that are registered for specific uses
that may result in residential exposure, such as pesticides used in and
around the home. Therefore, screening level residential handler and
post-application risk assessments have been performed for common
residential exposure scenarios, using assumptions detailed in the 2012
Residential SOPs (available at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide</a>).
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
to share a common mechanism of toxicity with any other substances, and
fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance exemption, therefore, EPA has assumed that fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Additional Safety Factor for the Protection of Infants and Children
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 Food Quality Protection Act
(FQPA) safety factor. 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.
Based on the evaluation of available toxicity studies, there is low
concern for pre- and postnatal susceptibility from exposure to fatty
acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether. The FQPA safety factor has been
reduced to 1X because: (1) the toxicity database is adequate to
characterize potential pre- and postnatal risk; (2) the established PoD
(160 mg/kg/day) will be protective of the body weight decrease in
offspring seen at 250 mg/kg/day in the 2-generation reproduction
toxicity study in rats; (3) no evidence of neurotoxicity was
[[Page 95135]]
observed in the database; and (4) the assumptions for the exposure
assessment are conservative and unlikely to underestimate risk.
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,
fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether 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
fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether from food and water will utilize
approximately 8.9% and 32.3% of the cPAD for the U.S. population and
children 1-2 years old (the most highly exposed populations).
3. Short- and intermediate term risks. Short- and intermediate term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposures to food and water
(considered to be a background exposure level).
Fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters
with polyethylene glycol mono-Me ether may be used as an inert
ingredient in pesticide products that are 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 fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether.
Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded the combined short-
and intermediate-term food, water, and residential exposures result in
an aggregate margin of exposure (MOE) of 268 for adults. Adult
residential exposure combines high end dermal and inhalation handler
exposure from aerosol spray/trigger pump with a high-end post
application dermal exposure from contact with treated lawns. The
combined short- and intermediate-term aggregated food, water, and
residential pesticide exposures result in an aggregate MOE of 127 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). Because EPA's level of concern for fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether is an MOE of 100 or below, these MOEs are not of
concern.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with
polyethylene glycol mono-Me ether in or on any food commodities. EPA is
establishing a limitation on the amount of fatty acids,
C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol mono-Me ether that may be used in pesticide formulations applied
pre- and post-harvest. This limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation for food use that exceeds
25% fatty acids, C<INF>16-18</INF> and C<INF>18</INF>-unsatd., esters
with polyethylene glycol mono-Me ether in the final pesticide
formulations to be applied pre- and post-harvest.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether
(CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant
and related adjuvant of surfactant) in pesticide formulations applied
to growing crops and raw agricultural commodities after harvest under
40 CFR 180.910, limited to a maximum concentration of 25% in a
pesticide formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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, titled ``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, titled ``Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22,
2001) or Executive Order 13045, titled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). 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, titled ``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 exemption 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, titled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, titled
``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
[[Page 95136]]
Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
VIII. 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: November 21, 2024.
Charles Smith,
Director, Registration Division, 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. In Sec. 180.910, amend Table 1 to 180.910 by adding, in
alphabetical order, the entry ``Fatty acids, C<INF>16-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol mono-Me ether''
to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Fatty acids, C16-18 and C18- 25% by weight Surfactant and
unsatd., esters with related adjuvant
polyethylene glycol mono-Me of surfactant.
ether (CAS Reg. No. 518299-31-
5).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2024-28080 Filed 11-29-24; 8:45 am]
BILLING CODE 6560-50-P
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