Rule2022-04123
Fatty Acids, Esters With Ethoxylated Triethanolamine; 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
February 28, 2022
Effective
February 28, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of fatty acids, tall-oil, esters with triethanolamine, ethoxylated (CAS Reg No. 68605-38-9) and fatty acids, C<INF>8-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene glycol ether with triethanolamine (3:1) (CAS Reg No. 2464873-19-4) (herein referred to 20ETO and 10ETO, respectively) when used as inert ingredients (surfactant) in pesticide formulations applied to growing crops pre- and post-harvest, not to exceed 10% in the final pesticide formulation. Exponent, Inc. on behalf of Lamberti USA, Incorporated 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 20ETO and 10ETO.
Full Text
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<title>Federal Register, Volume 87 Issue 39 (Monday, February 28, 2022)</title>
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[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10983-10989]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04123]
[[Page 10983]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0364; FRL-9534-01-OCSPP]
Fatty Acids, Esters With Ethoxylated Triethanolamine; 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 fatty acids, tall-oil, esters with
triethanolamine, ethoxylated (CAS Reg No. 68605-38-9) and fatty acids,
C<INF>8-18</INF> and C<INF>18</INF>-unsatd., esters with polyethylene
glycol ether with triethanolamine (3:1) (CAS Reg No. 2464873-19-4)
(herein referred to 20ETO and 10ETO, respectively) when used as inert
ingredients (surfactant) in pesticide formulations applied to growing
crops pre- and post-harvest, not to exceed 10% in the final pesticide
formulation. Exponent, Inc. on behalf of Lamberti USA, Incorporated
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 20ETO and 10ETO.
DATES: This regulation is effective February 28, 2022. Objections and
requests for hearings must be received on or before April 29, 2022, 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-2021-0364, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Due to the public health concerns related to
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is open to
visitors by appointment only. For the latest status information on EPA/
DC services and access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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:
<a href="/cdn-cgi/l/email-protection#cb998f8d9985a4bfa2a8aeb88baebbaae5aca4bd"><span class="__cf_email__" data-cfemail="32607674607c5d465b515741725742531c555d44">[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, 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-2021-0364 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
April 29, 2022. 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-2021-0364, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 August 3, 2021 (86 FR 41809) (FRL-8792-
01), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11506) by
Exponent, Inc. (1150 Connecticut Ave., Suite 1100, Washington, DC
20036) on behalf of Lamberti USA, Incorporated (P.O. Box 1000,
Hungerford, TX 77448). The petition requested that the 40 CFR be
amended by establishing an exemption from the requirement of a
tolerance for residues of 20ETO (CAS Reg No. 68605-38-9) and 10ETO (CAS
Reg No. 2464873-19-4) when used as inert ingredients (surfactant) in
pesticide formulations applied to growing crops pre- and post-harvest
under 40 CFR 180.910. That document referenced a summary of the
petition prepared by Exponent, Inc. on behalf of Lamberti USA,
Incorporated, the petitioner, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No comments were received on the notice of
filing.
Based upon review of the data supporting the petition, EPA has
limited the maximum concentration of 20ETO or 10ETO to not more than
10% in pesticide formulations for use under 40 CFR 180.910. This
limitation is based on the Agency's risk assessment which can be found
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled ``Fatty acids,
Tall-Oil, Esters with Triethanolamine, Ethoxylated (20ETO) and Fatty
Acids, C<INF>8-18</INF> or C<INF>18</INF>-Unsatd., Esters with
[[Page 10984]]
Polyethylene Glycol Ether with Triethanolamine (3:1) (10ETO); Human
Health Risk Assessment and Ecological Effects Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2021-0364.
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(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 . . . .''
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 appreciable risks 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 20ETO and 10ETO including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with 20ETO and 10ETO
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 20ETO and 10ETO 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.
EPA considered studies on either substance to evaluate the toxicity
of both substances. Based on the available data, the acute oral
toxicity is expected to be low for 20ETO and 10ETO because the oral
LD<INF>50</INF> (lethal dose) for 20ETO is greater than 2,000
milligrams/kilogram (mg/kg). Both substances are also not expected to
be acutely toxic via dermal exposure, as the LD<INF>50</INF> for 20ETO
is greater than 2,000 mg/kg in rats. The substances are also not
expected to be irritating to the skin in the rat and rabbit nor
sensitizing to the guinea pig. However, the substances are expected to
be minimally irritating to the rabbit eye.
No repeated-dose toxicity studies are available for 10ETO or 20ETO.
Therefore, data for triethanolamine (TEA) and fatty acids, tall oil
were used, based on the predicted degradation pathways of 20ETO and
10ETO. Subchronic oral toxicity studies in guinea pigs via gavage (TEA)
and rats (fatty acids, tall oil) via the diet resulted in
hepatocellular cloudy swelling and fatty change in the liver and cloudy
swelling of the convoluted tubules and Henle's loop in the kidney at
400 and 450 mg/kg/day, respectively, following 60- and 120-day
exposures. The no observed adverse effect level (NOAEL) in these
studies is 200 and 225 mg/kg/day for the guinea pig and rat,
respectively. Increased liver and kidney weights and histological
lesions are observed at 730 mg/kg/day in a 90-day oral toxicity study
in rats. The NOAEL in this study is 170 mg/kg/day. Chronic exposure via
drinking water (TEA) resulted in an increased incidence and severity of
chronic nephropathy at 455 mg/kg/day in rats. No LOAEL was established
in this study. In mice, decreased body weight was observed at 1,688 mg/
kg/day following chronic exposure via drinking water (TEA).
In subchronic dermal toxicity studies, no systemic toxicity was
observed up to 1,000 mg/kg/day, the limit dose, in rats. However, in
the same study, an increased incidence of hypertrophy of the pituitary
gland pars intermedia was observed at 2,000 mg/kg/day and dermal
effects manifested as increased incidence and severity of acanthosis
and inflammation at 500 mg/kg/day. In mice, no systemic toxicity was
observed up to 4,000 mg/kg/day following 13 weeks of exposure. Mild
dermal hyperplasia was observed at 140 mg/kg/day and an increased
incidence and severity of acanthosis was seen at 250 mg/kg/day.
Following chronic dermal exposure in rats, an increased incidence
of acanthosis and inflammation along with ulcers and dermal erosion was
observed at 63 mg/kg/day.
A developmental toxicity study showed no maternal or developmental
toxicity up to 1,125 mg/kg/day in mice. Another developmental toxicity
study via the dermal exposure showed no toxicity up to 30 mg/kg/day,
which was the highest dose tested in rats. Further, no parental,
offspring, or reproduction toxicity was observed in a 2-generation
reproduction toxicity study in rats (fatty acid, tall oil) up to 5,000
mg/kg/day. In a combined reproduction/developmental toxicity test, a
decrease in the number of implantation sites and litter size, and an
increase in the number of post-implantation loss were observed at 1,000
mg/kg/day. The NOAEL is 300 mg/kg/day. However,
[[Page 10985]]
there is no concern for fetal susceptibility or reproduction toxicity
since the cRfD (0.455 mg/kg/day) is protective of effects seen at 1,000
mg/kg/day.
Several mutagenicity studies with TEA and fatty acids, tall oil
(e.g., Ames, chromosome aberration, micronucleus assay, sister
chromatid exchange, and cell dominant lethal assay) were reviewed and
the results for these studies are negative.
Two chronic/carcinogenicity studies in which the test substance was
administered via drinking water were also reviewed. In mice, decreased
bodyweight was observed at 1,688 mg/kg/day. The NOAEL is 673 mg/kg/day.
No evidence of an increased incidence of tumors was seen in this study.
In rats, chronic nephropathy is observed in female rats at 455 mg/kg/
day. A NOAEL was not established in this study. An increased incidence
of hepatocellular adenomas was observed at doses greater than 1,000 mg/
kg/day. The chronic reference dose (cRfD) is based on this study.
Neurotoxicity and immunotoxicity studies are not available for
review. However, evidence of neurotoxicity and immunotoxicity was not
observed in the submitted 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/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
A summary of the toxicological endpoints for 20ETO and 10ETO used
for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for 20ETO and 10ETO for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13 to 50 An acute effect was not found in the database therefore an acute dietary
years of age, General population assessment is not necessary.
including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) LOAEL= 455 mg/kg/day Chronic RfD = 0.455 Chronic/Carcinogenicity Study
UFA = 10x........... mg/kg/day. (TEA).
UFH = 10x........... cPAD = 0.455 mg/kg/ LOAEL = 455 mg/kg/day based on
UFL = 10x........... day.. chronic nephropathy in female
FQPA SF = 1x........ rats.
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Incidental oral intermediate-term NOAEL= 300 mg/kg/day LOC for MOE = 100.. Combined Reproduction/
(1 to 6 months). UFA = 10x UFH = 10x. Developmental (TEA). LOAEL =
FQPA SF = 1x........ 1,000 mg/kg/day based on
decreased number of implantation
sites and litter size, and an
increased number of post-
implantation loss.
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Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 100.. 16-Day Inhalation Toxicity Study
days). NOAEL = 43.39 mg/kg/ (TEA). LOAEL = 86.77 mg/kg/day
day (inhalation based on laryngeal inflammation.
absorption rate =
100%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term (1 Inhalation study LOC for MOE = 1000. 16-Day Inhalation Toxicity Study
to 6 months). NOAEL = 43.39 mg/kg/ (TEA) LOAEL = 86.77 mg/kg/day
day (inhalation based on laryngeal inflammation.
absorption rate =
100%).
UFA = 10x...........
UFH = 10x...........
UFs = 10x...........
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) There is no evidence of carcinogenicity in the available database. The RfD
approach is protective of any potential carcinogenic effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 20ETO and 10ETO, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from 20ETO and 10ETO in food as follows:
In conducting the chronic dietary exposure assessment using the
Dietary
[[Page 10986]]
Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used food
consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 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 10ETO and 20ETO. 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 entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,''
(D361707, S. Piper, 2/25/09) and can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPP-2008-0738.
Generally, in the dietary exposure assessments for inert
ingredients, the Agency assumes 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. However, in assessing this petition request, the Agency assumed
that a product consisted of 10% percent 10ETO and 20ETO. 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.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that
all foods contain the inert ingredient at the highest tolerance level.
In other words, EPA assumed 100 percent of all foods are treated with
the inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, this conservative assumption
will lead to a significant exaggeration of actual exposures. EPA does
not believe that this approach underestimates exposure in the absence
of residue data.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for 10ETO and 20ETO, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. 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, for lawn and garden pest control, indoor pest control,
termiticides, flea and tick control on pets, and hard surface
disinfection on walls, floors, tables).
20ETO and 10ETO 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.
For residential handlers, the Agency assumed handlers may receive
short-term dermal and inhalation exposure to 20ETO and 10ETO from
formulations containing the inert ingredient in outdoor and indoor
scenarios. Short- and intermediate-term dermal exposures were not
quantitated since no systemic toxicity is observed in dermal toxicity
studies. Also, intermediate- and long-term inhalation exposures are not
expected because applications are not expected to occur daily or for
more than 30 days. Therefore, only short-term inhalation exposures were
estimated and were based on the NOAEL of 43.39 mg/kg/day and a LOC for
an MOE of 100. The short-term residential handler MOE is 36000, which
is not a risk of concern because EPA considers MOEs of 100 or less to
be of concern. The Agency also considered intermediate-term incidental
oral exposures to children due to residential exposure associated with
contact with treated surfaces (dermal and hand-to-mouth exposures). The
MOE is 1964 for children, which is not a risk of concern because EPA
considers MOEs of 100 or less to be of concern.
As introduced above, 10ETO and 20ETO are expected to biodegrade
into TEA and fatty acids, tall oil. Residential exposure to TEA may
occur from existing pesticide uses as well as from non-pesticide
products that may be used in and around the home, such as cosmetics.
Dermal contact is the primary route of exposure to TEA in cosmetics.
However, a dermal endpoint of concern was not identified, and therefore
a quantitative dermal exposure assessment is not necessary. TEA can be
used in products that may be sprayed, however, so there is the
potential for inhalation exposure. The Cosmetic Ingredient Review (CIR)
Expert Panel has noted that 95% to 99% of TEA particles produced in
cosmetic aerosols are not respirable. This assumption, coupled with the
small actual exposure in the breathing zone and the concentrations at
which TEA is used, suggests that inhalation would not be a significant
route of exposure that might lead to local respiratory or systemic
toxic effects (Fiume et. al., 2013). Small amounts of TEA may also be
ingested (oral exposure) from lipsticks as they are reported to
potentially contain up to 1% TEA. However, any contribution to the
estimated oral pesticide exposure resulting from cosmetic uses is
likely to
[[Page 10987]]
be insignificant in comparison to the estimates for exposure from the
pesticide use.
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.''
EPA has not found 20ETO and 10ETO to share a common mechanism of
toxicity with any other substances, and 20ETO and 10ETO do not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
20ETO and 10ETO do 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/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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.
The Agency has concluded that there is reliable data to determine
that infants and children will be safe if the FQPA SF of 10x is reduced
to 1X for the chronic dietary assessment for the following reasons. The
toxicity database for 20ETO and 10ETO contains developmental, 2-
generation reproduction, combined reproduction/developmental toxicity
and mutagenicity studies. There is no indication of immunotoxicity or
neurotoxicity in the available studies; therefore, there is no need to
require an immunotoxicity or neurotoxicity study. Additionally, no
fetal susceptibility or reproduction toxicity was observed in the
available studies. Based on the adequacy of the toxicity database, the
conservative nature of the exposure assessment and the lack of concern
for prenatal and postnatal sensitivity, the Agency has concluded that
there is reliable data to determine that infants and children will be
safe if the FQPA SF of 10x is reduced to 1X.
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,
20ETO and 10ETO 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
20ETO and 10ETO from food and water will utilize 32.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
3. Short-term risk. Short-term aggregate exposure generally takes
into account short-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level).
20ETO and 10ETO may be used as inert ingredients in pesticide
products that could result in short-term residential exposure. The
Agency has determined that it is not appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to 20ETO and 10ETO since toxicological effects were different depending
on the route of exposure.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term residential
exposures result in aggregate MOEs of 36000 for adult males and
females. Because EPA's level of concern for 20ETO and 10ETO is an 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).
20ETO and 10ETO may be used as inert ingredients in pesticide
products that could result in intermediate-term residential exposure,
and the Agency has determined that it is not appropriate to aggregate
chronic exposure through food and water with intermediate-term
residential exposures to 20ETO and 10ETO since toxicological effects
were different depending on the route of exposure.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 1964 for children. Children's residential exposure
includes total exposures associated with contact with treated surfaces
(dermal and hand-to-mouth exposures). Because EPA's level of concern
for children's residential exposure (incidental oral exposure) to 20ETO
and 10ETO is an MOE of 100 or below, this MOE is not of concern.
5. Long-term risk. Long-term aggregate exposure takes into account
long-term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Long-term residential exposures are not expected from the use of
20ETO and 10ETO in pesticides used in and around the home. Therefore,
long-term aggregate exposure considers chronic food and water. The MOE
is 10833 based on the cPAD of 0.455 mg/kg/day. As the level of concern
is for an MOE that is lower than 1000, this MOE is not of concern.
TEA, a metabolite of 10ETO and 20ETO, may be used as inert
ingredients in non-pesticide products that could result in long-term
residential exposure. Based on the exposure assumptions described in
unit IV. C. 3, the Agency anticipates that the contribution to the
estimated oral non-pesticide exposure due to its use in cosmetics is
likely to be insignificant in comparison to the estimates for exposure
from the pesticide use. Therefore, the Agency believes the assessments
of aggregate exposures due to pesticide uses more than adequately
protect for exposure from uses in cosmetics products.
6. Aggregate cancer risk for U.S. population. Based on the lack of
tumors in the carcinogenicity studies in rats and mice and the lack of
mutagenicity, 20ETO and 10ETO are not expected to pose a cancer risk to
humans.
7. Determination of safety. Taking into consideration all available
[[Page 10988]]
information on 20ETO and 10ETO, EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, including infants and children, from aggregate exposure to
20ETO and 10ETO residues.
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
20ETO and 10ETO in or on any food commodities. EPA is establishing a
limitation on the amount of 20ETO and 10ETO that may be used in
pesticide formulations. 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
10% in the final pesticide formulations for indoor and outdoor
residential use.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of 20ETO (CAS Reg No. 68605-38-9) and 10ETO
(CAS Reg No. 2464873-19-4) when used as inert ingredients (surfactant)
in pesticide formulations applied to growing crops pre- and post-
harvest under 40 CFR 180.910.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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), EPA seeks to
achieve environmental justice, the fair treatment and meaningful
involvement of any group, including minority and/or low-income
populations, in the development, implementation, and enforcement of
environmental laws, regulations, and policies. As such, to the extent
that information is publicly available or was submitted in comments to
EPA, the Agency considered whether groups or segments of the
population, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticide
discussed in this document, compared to the general population.
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance 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: February 22, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR part 180 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 inert ingredients ``Fatty acids, tall-oil, esters with
triethanolamine, ethoxylated'' and ``Fatty acids, C<INF>8-18</INF> and
C<INF>18</INF>-unsatd., esters with polyethylene glycol ether with
triethanolamine (3:1)'' to reads as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
[[Page 10989]]
Table 1 to 180.910
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits (%) Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Fatty acids, tall-oil, esters with triethanolamine, 10 Surfactant.
ethoxylated (CAS Reg. No. 68605-38-9).
Fatty acids, C8 18 and C18-unsatd., esters with 10 Surfactant.
polyethylene glycol ether with triethanolamine (3:1) (CAS
Reg. No. 2464873-19-4).
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2022-04123 Filed 2-25-22; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on February 28, 2022.
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