Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate]; Exemption From the Requirement of a Tolerance, 8441-8447 [2020-02043]
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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 24, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.578, amend the table in
paragraph (a)(1) as follows:
■ a. Remove the entries for ‘‘Brassica,
head and stem, subgroup 5A’’ and
‘‘Brassica, leafy greens, subgroup 5B’’;
■ b. Add alphabetically the entry
‘‘Brassica, leafy greens, subgroup 4–
16B’’;
■
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c. Remove the entry for ‘‘Canola,
seed’’;
■ d. Add alphabetically the entries
‘‘Celtuce’’ and ‘‘Cottonseed subgroup
20C’’;
■ e. Remove the entry for ‘‘Cotton,
undelinted seed’’;
■ f. Add alphabetically the entries
‘‘Fennel, florence, fresh leaves and
stalk’’ and ‘‘Fruit, stone, group 12–12’’;
■ g. Remove the entry for ‘‘Fruit, stone,
group 12, except plum, prune’’;
■ h. Add alphabetically the entries
‘‘Kohlrabi’’; ‘‘Leaf petiole vegetable
subgroup 22B’’; and ‘‘Leafy greens
subgroup 4–16A’’;
■ i. Remove the entries for ‘‘Mustard,
seed’’ and ‘‘Nut, tree, group 14’’;
■ j. Add alphabetically the entry ‘‘Nut,
tree, group 14–12’’;
■ k. Remove the entries for ‘‘Pistachio’’;
‘‘Plum, prune, dried’’; and ‘‘Plum,
prune, fresh’’;
■ l. Add alphabetically the entries
‘‘Rapeseed subgroup 20A’’ and
‘‘Tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B’’;
■ m. Remove the entry for ‘‘Turnip
greens’’;
■ n. Add alphabetically the entry
‘‘Vegetable, brassica, head and stem,
group 5–16’’; and
■ o. Remove the entry for ‘‘Vegetable,
leafy, except brassica, group 4’’.
The revisions and additions read as
follows:
■
*
*
*
*
Tropical and subtropical, medium
to large fruit, smooth, inedible
peel, subgroup 24B .................
Vegetable, brassica, head and
stem, group 5–16 ....................
*
*
*
[EPA–HQ–OPP–2019–0129; FRL–10002–96]
Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate];
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
when used as an inert ingredient
(stabilizer) limited to 1% (by weight) in
pesticide formulations applied to
growing crops, and raw agricultural
commodities after harvest. Syngenta
Crop Protection, 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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
when used in accordance with the terms
of this exemption.
DATES: This regulation is effective
February 14, 2020. Objections and
requests for hearings must be received
on or before April 14, 2020, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0129, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
SUMMARY:
Parts per
million
*
*
*
*
Celtuce ........................................
*
*
*
*
*
Cottonseed subgroup 20C .........
Fennel, florence, fresh leaves
and stalk ..................................
*
*
*
*
*
Fruit, stone, group 12–12 ...........
*
*
*
*
*
Kohlrabi .......................................
Leaf petiole vegetable subgroup
22B ..........................................
Leafy greens subgroup 4–16A ...
Nut, tree, group 14–12 ...............
*
*
*
*
*
Rapeseed subgroup 20A ............
*
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*
*
40 CFR Part 180
*
Fmt 4700
*
*
1.2
ENVIRONMENTAL PROTECTION
AGENCY
*
*
*
*
Brassica, leafy greens, subgroup
4–16B ......................................
Frm 00069
*
*
0.5
BILLING CODE 6560–50–P
(a) * * *
(1) * * *
PO 00000
*
*
[FR Doc. 2020–02038 Filed 2–13–20; 8:45 am]
§ 180.578 Acetamiprid; tolerances for
residues.
Commodity
Parts per
million
Commodity
15
3
0.7
3
1.5
1.2
3
3
0.1
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Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Publishing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0129 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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must be in writing, and must be
received by the Hearing Clerk on or
before April 14, 2020. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0129, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of June 7, 2019
(84 FR 26630) (FRL–9993–93), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP IN–
11245) by Syngenta Crop Protection,
LLC, 410 Swing Road, P.O. Box 18300,
Greensboro, NC 27419–8300. The
petition requested the establishment of
an exemption from the requirement of a
tolerance for residues of
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
(CAS Reg. No. 36443–68–2) when used
as an inert ingredient (stabilizer) at no
more than 1% by weight in pesticide
formulations applied to or on raw
agricultural commodities and growing
crops under 40 CFR 180.910. That
document referenced a summary of the
petition prepared by Syngenta Crop
Protection, LLC, the petitioner, which is
available in the docket at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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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. 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
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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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
follows.
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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 ethylenebis(oxyethylene) bi[3-(5-tertbutyl-4-hydroxy-m-tolyl)propionate] as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
Acute toxicity is low for
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]. In
rats, the lethal dose (LD50) for acute oral
and dermal toxicity is greater than 7,000
and 2,000 milligrams/kilogram/day (mg/
kg/day), respectively. It is not a dermal
or eye irritant, or a sensitizer.
Subchronic exposure to
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] in
rats resulted in increased liver weights
and alanine aminotransferase (ALAT)
activity at 112 mg/kg/day and minimal
thyroid follicular hypertrophy at doses
greater than 250 mg/kg/day. The
NOAELs were 37.4 and 50 mg/kg/day,
respectively. In dogs, no toxicity is seen
at doses up to 300 mg/kg/day, the
highest dose tested.
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No fetal susceptibility was observed
in the developmental studies. Maternal
toxicity (reduced bodyweight gain and
food consumption) occurs at 100 mg/kg/
day while developmental toxicity
(reduced bodyweight and delayed
skeletal maturation) occurs at 300 mg/
kg/day. The maternal NOAEL was not
established, and the developmental
NOAEL is 100 mg/kg/day.
Qualitative fetal susceptibility was
observed in the 2-generation
reproduction toxicity study. Pup
mortality and reduced body weight were
observed in offsprings at 900 parts per
million (ppm) (∼54 to 62 mg/kg/day). In
parents, decreased bodyweight gain and
food consumption occurred at the same
dose. However, the established chronic
reference dose (cRfD) of 0.15 mg/kg/day
will be protective of offspring effects.
The parental and offspring NOAELs are
300 ppm (∼21 to 26 mg/kg/day).
Reproduction toxicity was not observed
up to 1,800 ppm (∼108 to 124 mg/kg/
day), the highest dose tested.
The combined chronic/
carcinogenicity study showed focal
cystic dilatation of the liver sinusoids
and thyroid follicle hyperplasia at doses
greater than 50 mg/kg/day. The NOAEL
is 15 mg/kg/day. There was a treatmentrelated increase in thyroid tumor
incidence at 100 mg/kg/day in both
sexes. However, it is well established
that alterations in rat thyroid hormones
can alter the thyroid gland resulting in
tumor formation. Based on the
mechanistic studies, the postulated
mode of action is that
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
disrupts the rat thyroid-pituitary axis
primarily through interference of
peripheral T4 metabolism. The
relevancy of thyroid tumors to man is
limited, as rats are very sensitive to
small changes in plasma T4 levels while
humans are insensitive due to a number
of physiological differences including
the amount of thyroxin-binding globulin
present, half-life of T4 between different
species, and difference in
responsiveness to thyrotropin releasing
hormone. Therefore, the thyroid gland
tumors observed in this study are not
considered relevant to humans.
The Ames test, mammalian cell gene
mutation and micronucleus assays were
conducted with
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate].
These studies were negative; therefore,
it is not expected to be mutagenic.
Neurotoxicity and immunotoxicity
studies are not available for review.
However, evidence of neurotoxicity and
immunotoxicity is not observed in the
submitted studies.
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In a metabolism study in rats,
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
administered orally is rapidly absorbed
and metabolized. It is primarily excreted
in the urine and feces. Metabolites were
not identified in this study; however, it
is a phenolic antioxidant and based on
the classical metabolic pathway for this
class of chemicals, it would be subject
to glucuronide or sulphate conjugation,
hydroxylation of the phenyl ring, and
side chain oxidation. The resulting
metabolites are expected to be 3-(3-tertbutyl-4-hydroxy-5-methylphenyl)propanoic acid and 2-[2-(2hydroxyethoxy)ethoxy]ethanol
(triethylene glycol).
Dermal absorption rate was calculated
to be 0.53% in a dermal absorption
study in miniature pigs.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
The chronic/carcinogenicity toxicity
study in rats was selected for all
exposure scenarios. The NOAEL is 15
mg/kg/day, and the LOAEL is 50 mg/kg/
day based on focal cystic dilatation of
the liver sinusoids and thyroid follicle
hyperplasia. This represents the lowest
NOAEL in the database in the most
sensitive species. However, in the
developmental study, the maternal
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NOAEL is not established and the
maternal LOAEL is 100 mg/kg/day
based on decreased bodyweight gain
and food consumption. Also, decreased
bodyweight gain and food consumption
are observed in parental animals at 900
ppm (∼ 54 to 62 mg/kg/day) in the twogeneration reproduction toxicity study,
the NOAEL is 300 ppm (∼ 21 to 26 mg/
kg/day). Since, maternal and parental
effects are the same in both studies, a
parental NOAEL is established and
treatment duration is longer in the twogeneration reproduction toxicity study,
it is considered adequate to address the
lack of a maternal NOAEL in the
developmental study. The standard
inter- and intra-species uncertainty
factors of 10x are applied; as discussed
below in Unit IV.D., the Agency applied
a 1X Food Quality Protection Act Safety
Factor (FQPA) SF. The dermal
absorption factor of 0.53% is applied
based on a dermal absorption study in
miniature pigs. 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 ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate], EPA considered exposure
under the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] in
food as follows:
No adverse effects attributable to a
single exposure of endpoint was
identified for ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate]; therefore, an acute dietary
exposure assessment was not
conducted.
In conducting the chronic dietary
exposure assessment using the Dietary
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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]. 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
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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 https://www.regulations.gov in
docket ID number EPA–HQ–OPP–2008–
0738.
In the dietary exposure assessment,
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.
Although EPA is assessing
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate at
1.75% (to account for the requested 1%
(by weight) limitation in pesticide
formulations and up to 0.75% limitation
for the FDA approved uses as an
antioxidant and/or stabilizer for
polymers used for food contact
applications, the Agency believes the
assumptions used to estimate dietary
exposures lead to an very conservative
assessment of dietary risk due to other
conservative assumptions.
First, EPA assumes 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.
Also, EPA’s assumes 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
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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, the
compounding of these conservative
assumptions 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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate], 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl)propionate] is
registered for use as an inert ingredient
in pesticide products that are registered
for specific uses that may result in
residential exposure, specifically lawn,
turf, and garden use, and in indoor
cleaning products. A conservative
residential exposure and risk
assessment was completed for pesticide
products containing
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] as
inert ingredients. The Agency assessed
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] in
pesticide formulations (outdoor
scenarios) and in disinfectant-type uses
(indoor scenarios) at no more than 1%
in the final formulation. The Agency’s
assessment of adult residential exposure
combines high end dermal and
inhalation handler exposure from
indoor hard surface, aerosol spray with
a high-end post application dermal
exposure from contact with treated
lawns. The Agency’s assessment of
children’s residential exposure includes
total post-application exposures
associated with contact with treated
surfaces (dermal and hand-to-mouth
exposures).
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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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] to
share a common mechanism of toxicity
with any other substances, and
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] 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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for 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
FQPA 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 all exposure
scenarios for the following reasons. The
toxicity database for
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
contains subchronic, developmental,
reproduction, chronic/carcinogenicity,
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.
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Fetal susceptibility is not observed in
developmental toxicity studies in the
rat. Developmental toxicity (reduced
fetal body weight and delayed skeletal
maturation) occurred at a higher dose,
300 mg/kg/day, than maternal toxicity
(reduced body weight gain), which
occurred at 100 mg/kg/day. Qualitative
fetal susceptibility toxicity is observed
2-generation reproduction toxicity
study. Pup mortality and reduced pup
body weight is observed at 900 ppm
(∼54–62 mg/kg/day), while parental
toxicity is manifested as decreased
bodyweight gain and food consumption
at the same dose. However, the
established cRfD of 0.15 mg/kg/day will
be protective of any offspring effects
seen at 900 ppm (∼54–62 mg/kg/day).
Therefore, there is no concern for fetal
susceptibility. Reproduction toxicity is
not observed up to 1,800 ppm (87–221
mg/kg/day), the highest dose tested.
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,
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] 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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
from food and water will utilize 18.4%
of the cPAD for children 1 to 2 years
old, the population group receiving the
greatest exposure.
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8445
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] is
currently 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 ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate].
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 1,235 for adult males and
females. Adult residential exposure
combines high-end dermal and
inhalation handler exposure from
indoor hard surface, aerosol spray with
a high-end post-application dermal
exposure from contact with treated
lawns. The combined short-term
aggregated food, water, and residential
pesticide exposures result in an
aggregate MOE of 511 for children.
Children’s residential exposure includes
total exposures associated with contact
with treated surfaces (dermal and handto-mouth exposures). Because EPA’s
level of concern for
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] is
a MOE of 100 or below, these MOEs are
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).
Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] is
currently used as an inert ingredient in
pesticide products that are registered for
uses that could result in intermediateterm residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate].
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in aggregate MOEs of 1,729 for adult
males and females. Adult residential
exposure includes high-end post-
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application dermal exposure from
contact with treated lawns. The
combined intermediate-term aggregated
food, water, and residential exposures
result in an aggregate MOE of 413 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 ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] is a MOE of 100 or below,
these MOEs are not of concern.]
5. Aggregate cancer risk for U.S.
population. In a chronic/carcinogenicity
study, thyroid gland tumors are
observed at 100 mg/kg/day in rats.
However, based on the postulated mode
of action for these tumors, they are not
considered relevant to humans. Also,
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] is
not mutagenic. Therefore,
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] is
not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
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
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate] in
or on any food commodities. EPA is
establishing limitations on the amount
of ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
that may be used in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest. These limitations 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 use on growing crops
and raw agricultural commodities after
harvest for sale or distribution that
exceeds 1% by weight of
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
unless additional data are submitted.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
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under 40 CFR 180.910 for
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
(CAS Reg No. 36443–68–2) when used
as an inert ingredient (stabilizer),
limited to 1% (by weight) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest.
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), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the 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
PO 00000
Frm 00074
Fmt 4700
Sfmt 4700
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: January 17, 2020.
Donna Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredient
‘‘Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
(CAS Reg. No. 36443–68–2)’’ to the table
to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
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TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
*
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] (CAS Reg. No. 36443–68–
2).
*
1% by weight ........
*
*
*
[FR Doc. 2020–02043 Filed 2–13–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0718 and EPA–HQ–
OPP–2019–0076; FRL–10002–06]
Difenoconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
difenoconazole in or on vegetable, root,
subgroup 1A, except ginseng; vegetable,
leaves of root and tuber, group 2; and
tea, dried. In addition, this regulation
amends the tolerances for residues of
difenoconazole in or ginseng; cattle,
liver; goat, liver; horse, liver; and sheep,
liver. Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
February 14, 2020. Objections and
requests for hearings must be received
on or before April 14, 2020, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0718 and
EPA–HQ–OPP–2019–0076, is available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
*
*
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2018–0718 and EPA–HQ–OPP–
2019–0076 in the subject line on the
PO 00000
Frm 00075
Fmt 4700
Sfmt 4700
Uses
*
Stabilizer.
*
*
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 14, 2020. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2018–0718 and EPA–HQ–OPP–2019–
0076, by one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of June 7, 2019
(84 FR 26630) (FRL–9993–93) and in the
Federal Register of May 9, 2019 (84 FR
20320) (FRL–9992–36), EPA issued
documents pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide
petitions (PP 8F8695 and 8E8728,
respectively) by Syngenta Crop
Protection, LLC, P.O. Box 18300,
Greensboro, NC 27419. Pesticide
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]]>Agencies
[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8441-8447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02043]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0129; FRL-10002-96]
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate]; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] when used as an inert ingredient
(stabilizer) limited to 1% (by weight) in pesticide formulations
applied to growing crops, and raw agricultural commodities after
harvest. Syngenta Crop Protection, 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 ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] when used in accordance with the terms of this
exemption.
DATES: This regulation is effective February 14, 2020. Objections and
requests for hearings must be received on or before April 14, 2020, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0129, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William
[[Page 8442]]
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0129 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 14, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0129, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-
93), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11245) by
Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300,
Greensboro, NC 27419-8300. The petition requested the establishment of
an exemption from the requirement of a tolerance for residues of
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] (CAS Reg. No. 36443-68-2) when used as an inert ingredient
(stabilizer) at no more than 1% by weight in pesticide formulations
applied to or on raw agricultural commodities and growing crops under
40 CFR 180.910. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the petitioner, which is
available in the docket at https://www.regulations.gov. 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. 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
[[Page 8443]]
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 ethylenebis(oxyethylene) bis[3-
(5-tert-butyl-4-hydroxy-m-tolyl) propionate] including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] 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 ethylenebis(oxyethylene) bi[3-(5-tert-
butyl-4-hydroxy-m-tolyl)propionate] 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.
Acute toxicity is low for ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate]. In rats, the lethal dose
(LD50) for acute oral and dermal toxicity is greater than
7,000 and 2,000 milligrams/kilogram/day (mg/kg/day), respectively. It
is not a dermal or eye irritant, or a sensitizer.
Subchronic exposure to ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] in rats resulted in increased
liver weights and alanine aminotransferase (ALAT) activity at 112 mg/
kg/day and minimal thyroid follicular hypertrophy at doses greater than
250 mg/kg/day. The NOAELs were 37.4 and 50 mg/kg/day, respectively. In
dogs, no toxicity is seen at doses up to 300 mg/kg/day, the highest
dose tested.
No fetal susceptibility was observed in the developmental studies.
Maternal toxicity (reduced bodyweight gain and food consumption) occurs
at 100 mg/kg/day while developmental toxicity (reduced bodyweight and
delayed skeletal maturation) occurs at 300 mg/kg/day. The maternal
NOAEL was not established, and the developmental NOAEL is 100 mg/kg/
day.
Qualitative fetal susceptibility was observed in the 2-generation
reproduction toxicity study. Pup mortality and reduced body weight were
observed in offsprings at 900 parts per million (ppm) (~54 to 62 mg/kg/
day). In parents, decreased bodyweight gain and food consumption
occurred at the same dose. However, the established chronic reference
dose (cRfD) of 0.15 mg/kg/day will be protective of offspring effects.
The parental and offspring NOAELs are 300 ppm (~21 to 26 mg/kg/day).
Reproduction toxicity was not observed up to 1,800 ppm (~108 to 124 mg/
kg/day), the highest dose tested.
The combined chronic/carcinogenicity study showed focal cystic
dilatation of the liver sinusoids and thyroid follicle hyperplasia at
doses greater than 50 mg/kg/day. The NOAEL is 15 mg/kg/day. There was a
treatment-related increase in thyroid tumor incidence at 100 mg/kg/day
in both sexes. However, it is well established that alterations in rat
thyroid hormones can alter the thyroid gland resulting in tumor
formation. Based on the mechanistic studies, the postulated mode of
action is that ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] disrupts the rat thyroid-pituitary axis primarily
through interference of peripheral T4 metabolism. The relevancy of
thyroid tumors to man is limited, as rats are very sensitive to small
changes in plasma T4 levels while humans are insensitive due to a
number of physiological differences including the amount of thyroxin-
binding globulin present, half-life of T4 between different species,
and difference in responsiveness to thyrotropin releasing hormone.
Therefore, the thyroid gland tumors observed in this study are not
considered relevant to humans.
The Ames test, mammalian cell gene mutation and micronucleus assays
were conducted with ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate]. These studies were negative; therefore,
it is not expected to be mutagenic.
Neurotoxicity and immunotoxicity studies are not available for
review. However, evidence of neurotoxicity and immunotoxicity is not
observed in the submitted studies.
In a metabolism study in rats, ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate] administered orally is
rapidly absorbed and metabolized. It is primarily excreted in the urine
and feces. Metabolites were not identified in this study; however, it
is a phenolic antioxidant and based on the classical metabolic pathway
for this class of chemicals, it would be subject to glucuronide or
sulphate conjugation, hydroxylation of the phenyl ring, and side chain
oxidation. The resulting metabolites are expected to be 3-(3-tert-
butyl-4-hydroxy-5-methyl-phenyl)propanoic acid and 2-[2-(2-
hydroxyethoxy)ethoxy]ethanol (triethylene glycol).
Dermal absorption rate was calculated to be 0.53% in a dermal
absorption study in miniature pigs.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
The chronic/carcinogenicity toxicity study in rats was selected for
all exposure scenarios. The NOAEL is 15 mg/kg/day, and the LOAEL is 50
mg/kg/day based on focal cystic dilatation of the liver sinusoids and
thyroid follicle hyperplasia. This represents the lowest NOAEL in the
database in the most sensitive species. However, in the developmental
study, the maternal
[[Page 8444]]
NOAEL is not established and the maternal LOAEL is 100 mg/kg/day based
on decreased bodyweight gain and food consumption. Also, decreased
bodyweight gain and food consumption are observed in parental animals
at 900 ppm (~ 54 to 62 mg/kg/day) in the two-generation reproduction
toxicity study, the NOAEL is 300 ppm (~ 21 to 26 mg/kg/day). Since,
maternal and parental effects are the same in both studies, a parental
NOAEL is established and treatment duration is longer in the two-
generation reproduction toxicity study, it is considered adequate to
address the lack of a maternal NOAEL in the developmental study. The
standard inter- and intra-species uncertainty factors of 10x are
applied; as discussed below in Unit IV.D., the Agency applied a 1X Food
Quality Protection Act Safety Factor (FQPA) SF. The dermal absorption
factor of 0.53% is applied based on a dermal absorption study in
miniature pigs. 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 ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate], EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] in food as follows:
No adverse effects attributable to a single exposure of endpoint
was identified for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate]; therefore, an acute dietary exposure
assessment was not conducted.
In conducting the chronic dietary exposure assessment using the
Dietary 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 ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate]. 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 https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, 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.
Although EPA is assessing ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate at 1.75% (to account for the
requested 1% (by weight) limitation in pesticide formulations and up to
0.75% limitation for the FDA approved uses as an antioxidant and/or
stabilizer for polymers used for food contact applications, the Agency
believes the assumptions used to estimate dietary exposures lead to an
very conservative assessment of dietary risk due to other conservative
assumptions.
First, EPA assumes 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.
Also, EPA's assumes 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, the compounding of these
conservative assumptions 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
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate], 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., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl)propionate] is registered for use as an inert ingredient in
pesticide products that are registered for specific uses that may
result in residential exposure, specifically lawn, turf, and garden
use, and in indoor cleaning products. A conservative residential
exposure and risk assessment was completed for pesticide products
containing ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] as inert ingredients. The Agency assessed
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] in pesticide formulations (outdoor scenarios) and in
disinfectant-type uses (indoor scenarios) at no more than 1% in the
final formulation. The Agency's assessment of adult residential
exposure combines high end dermal and inhalation handler exposure from
indoor hard surface, aerosol spray with a high-end post application
dermal exposure from contact with treated lawns. The Agency's
assessment of children's residential exposure includes total post-
application exposures associated with contact with treated surfaces
(dermal and hand-to-mouth exposures).
[[Page 8445]]
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 ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate] to share a common mechanism of toxicity
with any other substances, and ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for 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 FQPA 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 all exposure scenarios for the following reasons. The
toxicity database for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate] contains subchronic, developmental,
reproduction, chronic/carcinogenicity, 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. Fetal susceptibility is not observed in
developmental toxicity studies in the rat. Developmental toxicity
(reduced fetal body weight and delayed skeletal maturation) occurred at
a higher dose, 300 mg/kg/day, than maternal toxicity (reduced body
weight gain), which occurred at 100 mg/kg/day. Qualitative fetal
susceptibility toxicity is observed 2-generation reproduction toxicity
study. Pup mortality and reduced pup body weight is observed at 900 ppm
(~54-62 mg/kg/day), while parental toxicity is manifested as decreased
bodyweight gain and food consumption at the same dose. However, the
established cRfD of 0.15 mg/kg/day will be protective of any offspring
effects seen at 900 ppm (~54-62 mg/kg/day). Therefore, there is no
concern for fetal susceptibility. Reproduction toxicity is not observed
up to 1,800 ppm (87-221 mg/kg/day), the highest dose tested. 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,
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] 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
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] from food and water will utilize 18.4% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] is currently 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 ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate].
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 1,235 for adult
males and females. Adult residential exposure combines high-end dermal
and inhalation handler exposure from indoor hard surface, aerosol spray
with a high-end post-application dermal exposure from contact with
treated lawns. The combined short-term aggregated food, water, and
residential pesticide exposures result in an aggregate MOE of 511 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 ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is a MOE of 100 or
below, these MOEs are 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).
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] is currently used as an inert ingredient in pesticide
products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate].
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
aggregate MOEs of 1,729 for adult males and females. Adult residential
exposure includes high-end post-
[[Page 8446]]
application dermal exposure from contact with treated lawns. The
combined intermediate-term aggregated food, water, and residential
exposures result in an aggregate MOE of 413 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 ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] is a MOE of 100 or below, these
MOEs are not of concern.]
5. Aggregate cancer risk for U.S. population. In a chronic/
carcinogenicity study, thyroid gland tumors are observed at 100 mg/kg/
day in rats. However, based on the postulated mode of action for these
tumors, they are not considered relevant to humans. Also,
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] is not mutagenic. Therefore, ethylenebis(oxyethylene)
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is not expected to
pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] 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
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] in or on any food commodities. EPA is establishing
limitations on the amount of ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] that may be used in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest. These limitations 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 use on growing crops and raw agricultural
commodities after harvest for sale or distribution that exceeds 1% by
weight of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] unless additional data are submitted.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate] (CAS Reg No. 36443-68-2) when
used as an inert ingredient (stabilizer), limited to 1% (by weight) in
pesticide formulations applied to growing crops and raw agricultural
commodities after harvest.
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), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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: January 17, 2020.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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, add alphabetically the inert ingredient
``Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)
propionate] (CAS Reg. No. 36443-68-2)'' to the table to read as
follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
[[Page 8447]]
Table 1 to 180.910
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Ethylenebis(oxyethylene) bis[3-(5-tert- 1% by weight...................... Stabilizer.
butyl-4-hydroxy-m-tolyl) propionate]
(CAS Reg. No. 36443-68-2).
* * * * * * *
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[FR Doc. 2020-02043 Filed 2-13-20; 8:45 am]
BILLING CODE 6560-50-P
