Rule2022-23997
Acetic Acid, 2-Ethylhexyl Ester; Exemption From the Requirement of a Tolerance
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
November 8, 2022
Effective
November 8, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of acetic acid, 2-ethylhexyl ester (CAS Reg. No. 103-09-3) when used as an inert ingredient (solvent/cosolvent) at a concentration not to exceed 50% in pesticide formulations applied to growing crops. SciReg, Inc., on behalf of Solvay USA Inc., 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 acetic acid, 2-ethylhexyl ester, when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 215 (Tuesday, November 8, 2022)</title>
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[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Rules and Regulations]
[Pages 67371-67375]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23997]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0084; FRL-10295-01-OCSPP]
Acetic Acid, 2-Ethylhexyl Ester; Exemption From the Requirement
of a Tolerance
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 acetic acid, 2-ethylhexyl ester (CAS
Reg. No. 103-09-3) when used as an inert ingredient (solvent/cosolvent)
at a concentration not to exceed 50% in pesticide formulations applied
to growing crops. SciReg, Inc., on behalf of Solvay USA Inc., 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 acetic acid, 2-ethylhexyl
ester, when used in accordance with the terms of the exemption.
DATES: This regulation is effective November 8, 2022. Objections and
requests for hearings must be received on or before January 9, 2023,
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-2017-0084, 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. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-2875; email address:
<a href="/cdn-cgi/l/email-protection#72203634203c1d061b111701321702135c151d04"><span class="__cf_email__" data-cfemail="bceef8faeef2d3c8d5dfd9cffcd9ccdd92dbd3ca">[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 Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</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
[[Page 67372]]
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0084 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 9, 2023. 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-2017-0084, 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">https://www.epa.gov/dockets/where-send-comments-epa-dockets</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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11014) by
SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of
Solvay USA Inc., 504 Carnegie Center, Princeton, NJ 08540. The petition
requested that 40 CFR 180.920 be amended by establishing an exemption
from the requirement of a tolerance for residues of acetic acid, 2-
ethylhexyl ester (CAS Reg. No. 103-09-3) when used as an inert
ingredient (solvent/co-solvent) in pesticide formulations at no more
than 50% when applied to growing crops only under 40 CFR 180.920. That
document referenced a summary of the petition prepared by SciReg, Inc.,
on behalf of Solvay USA Inc., the petitioner, which is available in the
docket, <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 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. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). 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
making safety determinations, e.g., 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, among others.
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 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 acetic acid, 2-ethylhexyl ester
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with acetic
acid, 2-ethylhexyl ester 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 acetic acid, 2-ethylhexyl ester 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 acetic acid, 2-ethylhexyl ester is
supported by data on the oxy-alkyl acetates and 2-
[[Page 67373]]
ethyl-1-hexanol. EPA has determined that it is appropriate to bridge
the data due to similarities in the manufacturing processes, functional
groups/structure, composition, and physical/chemical properties of
these chemicals.
Based on the results of surrogate data, acetic acid, 2-ethylhexyl
ester is expected to exhibit low levels of acute toxicity via the oral,
dermal, and inhalation routes of exposure. In the rat, the oral
LD<INF>50</INF> is 5,000 mg/kg, the dermal LD<INF>50</INF> is 3,160 mg/
kg and the inhalation LC is >1,100 ppm. Studies showed slight/moderate
skin and eye irritation and no protein binding alerts for skin
sensitization were found.
Two oral subchronic studies, a subchronic inhalation study, and a
developmental study conducted using surrogate chemicals were evaluated.
In a 28-day gavage study in rats with oxo-hexyl acetate, no effects
were seen up to the limit dose of 1,000 mg/kg/day. A 90-day study
gavage study in rats with oxo-octyl acetate showed kidney effects (mild
tubular nephropathy) in high-dose males only at the LOAEL of 1,000 mg/
kg/day. The 90-day inhalation study in rats with 2-ethyl-1-hexanol
showed no effects up to the highest dose tested (638.4 mg/m\3\).
In a developmental toxicity study, oxo-octyl acetate was
administered by gavage to pregnant female rats. Decreased maternal body
weight and food consumption, as well as fetal vertebral malformations,
were noted at 1,000 mg/kg/day only. Two animals in the high dose group
died, no etiology was given. The developmental and maternal systemic
NOAEL was 500 mg/kg/day, and the LOAEL was 1,000 mg/kg/day.
No evidence of neurotoxicity or immunotoxicity was reported.
Furthermore, concern for carcinogenicity is low based on negative
results in mutagenicity studies, and the lack of structural alerts for
carcinogenicity.
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>.
The hazard profile of acetic acid, 2-ethylhexyl ester is adequately
defined. Overall, acetic acid, 2-ethylhexyl ester is of low acute,
subchronic, and developmental toxicity. No systemic toxicity was
observed at doses that are relevant for risk assessment (i.e., doses
below 1,000 mg/kg/day). Since signs of toxicity were not observed below
1,000 mg/kg/day, no toxicological endpoints of concern or PODs were
identified. Therefore, a qualitative risk assessment for acetic acid,
2-ethylhexyl ester can be performed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetic acid, 2-ethylhexyl ester, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from acetic acid, 2-ethylhexyl ester in food
as follows:
Dietary exposure (food and drinking water) to acetic acid, 2-
ethylhexyl ester may occur following ingestion of foods with residues
from their use in accordance with this exemption. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
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). Acetic
acid, 2-ethylhexyl ester may be present in pesticide and non-pesticide
products that may be used in and around the home. However, a
quantitative residential exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
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.''
Based on the lack of toxicity below the limit dose, EPA has not
found acetic acid, 2-ethylhexyl ester to share a common mechanism of
toxicity with any other substances, and acetic acid, 2-ethylhexyl ester
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance exemption, therefore,
EPA has assumed that acetic acid, 2-ethylhexyl ester 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 (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.
Because there were no adverse effects below 1,000 mg/kg/day
associated with acetic acid, 2-ethylhexyl ester, EPA conducted a
qualitative assessment. As part of that assessment, the Agency did not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children. Based on an
assessment of acetic acid, 2-ethylhexyl ester, EPA has concluded that
there are no toxicological endpoints of concern for
[[Page 67374]]
the U.S. population, including infants and children.
E. Aggregate Risks and Determination of Safety
Because no toxicological endpoints of concern were identified below
the limit dose, 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 acetic acid, 2-ethylhexyl ester
residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
acetic acid, 2-ethylhexyl ester in or on any food commodities. EPA is
establishing a limitation on the amount of acetic acid, 2-ethylhexyl
ester that may be used in pesticide formulations applied pre-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 50% acetic acid, 2-ethylhexyl
ester in the final pesticide formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of acetic acid, 2-ethylhexyl ester (CAS Reg.
No. 103-09-3) when used as an inert ingredient (solvent/co-solvent) at
a maximum of 50% by weight in pesticide formulations applied to growing
crops only under 40 CFR 180.920.
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, 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). 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 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, 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).
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: October 31, 2022.
Jennifer Saunders,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, amend table 1 by adding, in alphabetical order, an
entry for ``Acetic acid, 2-ethylhexyl ester (CAS Reg. No. 103-09-3)''
to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to 180.920
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Inert ingredients Limits Uses
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Acetic acid, 2-ethylhexyl ester (CAS Not to exceed 50% by weight in Solvent/Co-solvent.
Reg. No. 103-09-3). pesticide formulation.
* * * * * * *
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[FR Doc. 2022-23997 Filed 11-7-22; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.