Alcohols, C2-33, 47136-47141 [2019-19398]
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Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations
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.
§ 180.449 Avermectin B1 and its delta-8,9isomer; tolerances for residues.
(a) * * *
Parts
per
million
Commodity
*
*
*
*
*
Carrot, roots ..............................................
*
*
*
*
*
Celtuce ......................................................
*
*
*
*
*
Fennel, Florence, fresh leaves and stalk ..
*
*
*
*
*
Garden cress .............................................
*
*
*
*
*
Leaf petiole vegetable subgroup 22B .......
Leafy greens subgroup 4–16A ..................
*
*
*
*
*
Tropical and subtropical, small fruit, inedible peel, subgroup 24A .........................
Upland cress .............................................
*
*
*
*
*
Vegetable, legume, dried shelled, except
soybean, subgroup 6C ..........................
Vegetable, legume, edible podded, subgroup 6A ................................................
Vegetable, legume, succulent shelled,
subgroup 6B ..........................................
*
*
*
*
*
*
*
*
1. The authority citation for part 180
continues to read as follows:
40 CFR Part 180
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.449, amend the table in
paragraph (a) as follows:
■ a. Add alphabetically the entries
‘‘Arugula’’; ‘‘Carrot, roots’’; ‘‘Celtuce’’;
‘‘Fennel, Florence, fresh leaves and
stalk’’; ‘‘Garden cress’’; ‘‘Leaf petiole
vegetable subgroup 22B’’; and ‘‘Leafy
greens subgroup 4–16A’’;
■ b. Remove the entry for ‘‘Lychee’’;
■ c. Add alphabetically the entries
‘‘Tropical and subtropical, small fruit,
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This regulation is effective
September 9, 2019. Objections and
requests for hearings must be received
on or before November 8, 2019, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
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[EPA–HQ–OPP–2018–0203; FRL–9998–48]
Alcohols, C2–33, Manuf. of By-Products
From, Overheads; 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 alcohols, C2–33,
manuf. of, by-products from, overheads
SUMMARY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0203, 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
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
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BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
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PART 180—[AMENDED]
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[FR Doc. 2019–19400 Filed 9–6–19; 8:45 am]
Therefore, 40 CFR chapter I is
amended as follows:
when used as an inert ingredient
(solvent) in pesticide products applied
to growing crops and raw agricultural
commodities after harvest, and to
animals. Spring Trading Company, on
behalf of Sasol Chemicals (USA) LLC,
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
alcohols, C2–33, manuf. of, by-products
from, overheads when used in
accordance with the terms of those
exemptions.
DATES:
*
*
*
*
Arugula ......................................................
*
Dated: August 28, 2019.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
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inedible peel, subgroup 24A’’ and
‘‘Upland cress’’;
■ d. Remove the entry for ‘‘Vegetable,
leafy, except brassica group 4’’; and
■ e. Add alphabetically the entries
‘‘Vegetable, legume, dried shelled,
except soybean, subgroup 6C’’;
‘‘Vegetable, legume, edible podded,
subgroup 6A’’; and ‘‘Vegetable, legume,
succulent shelled, subgroup 6B’’.
The additions read as follows:
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
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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).
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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.
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–2018–0203 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 November 8, 2019. 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–
2018–0203, 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
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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 August 24,
2018 (83 FR 42818) (FRL–9982–37),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11098) by Spring
Trading Company (203 Dogwood Trail,
Magnolia, TX 77354) on behalf of Sasol
Chemicals (USA) LLC (12120
Wickchester Lane, Houston, TX 77079).
The petition requested that the 40 CFR
be amended by establishing exemptions
from the requirement of a tolerance for
residues of alcohols, C2–33, manuf. of,
by-products from, overheads (CAS Reg.
No. 876065–86–0) when used as an inert
ingredient (solvent) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest under 40 CFR 180.910 and to
animals under 40 CFR 180.930. That
document referenced a summary of the
petition prepared by Spring Trading
Company on behalf of Sasol Chemicals
(USA) LLC, the petitioner, which is
available in the docket, https://
www.regulations.gov. One relevant
comment was received on the notice of
filing. EPA’s response to this comment
is discussed in Unit V.B.
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
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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(c)(2)(B) requires EPA, in making a
determination of safety for the
exemption, to take into account the
factors in subparagraphs (b)(2)(C) and
(D). Section 408(b)(2)(C) of FFDCA
requires EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
residue in establishing a tolerance and
to ‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue. . . .’’
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 alcohols, C2–33,
manuf. of, by-products from, overheads
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with alcohols, C2–33, manuf.
of, by-products from, overheads follow.
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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 alcohols, C2–33, manuf. of, byproducts from, overheads as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
C2–33 manuf. of, by-products from,
overheads are the by-products obtained
as solvent stripper overheads after
removal of non-alkoxide components
during the manufacture of alcohols from
ethylene by the Ziegler process. It
consists predominantly of paraffins,
olefins, naphthenes and esters having
carbon numbers in the range C2–34 and
melting in the range of approximately
¥17.5 °C to ¥4.1 °C.
The acute oral and dermal toxicity is
low in rats treated with alcohols, C2–33,
manuf. of, by-products from, overheads;
the lethal dose, LD50 is >2,000
milligrams/kilogram (mg/kg). It is not a
dermal sensitizer in the guinea pig.
Acute inhalation toxicity studies are not
available for review. Alcohols, C2–33,
manuf. of, by-products from, overheads
are not a skin or eye irritant in rabbits.
Three repeated dose studies via oral
exposure are available with alcohols,
C2–33, manuf. of, by-products from,
overheads in rats: A 14-day range
finding toxicity study; a combined
repeated dose toxicity study with the
reproduction/developmental toxicity
screening tests in rats; and a 2generation toxicity study in rats.
Following 14 days of oral exposure to
alcohols, C2–33, manuf. of, by-products
from, overheads in rats, no toxicity is
seen at 1,000 mg/kg/day. In the
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening tests in rats, parental
and offspring toxicities are observed at
1,000 mg/kg/day. Parental and
reproduction toxicities are manifested
as an increased number of females
giving birth to dead pups and offspring
toxicity is manifested as reduced pup
viability. The NOAELs are 500 mg/kg/
day. In the 2-generation reproduction
toxicity study, offspring toxicity is
manifested as reduced pup viability.
The NOAEL is 500 mg/kg/day. In a
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reproduction toxicity study in rats,
parental, offspring and reproduction
toxicities are seen at 1,000 mg/kg/day.
Parental toxicity manifests as reduced
body weights and/or weight gain in F0
females during mating and in F1 females
during gestation and reduced food
consumption, offspring toxicity
manifests as delayed vaginal opening
and preputial separation and reduced
ovarian follicles and reproduction
toxicity manifests as lower numbers of
implantation sites and lower litter size
with correlating lower litter weight
noted in both generations. The NOAELs
are 500 mg/kg/day. Increase fetal
susceptibility is not observed as
offspring toxicity occurs in the presence
of maternal toxicity. The combined
repeated dose toxicity studies with the
reproduction/developmental toxicity
screening tests and the 2-generation
toxicity study in rats are considered cocritical, the chronic reference dose
(cRfD) of 5.0 mg/kg/day is based on
these studies and is protective of the
effects observed at 1,000 mg/kg/day.
Carcinogenicity studies with alcohols,
C2–33, manuf. of, by-products from,
overheads are not available. However,
based on the lack of mutagenicity in the
Ames test, alcohols, C2–33, manuf. of, byproducts are not expected to be
carcinogenic.
Neurotoxicity studies are not
available for review. However, detailed
functional observations (FOB), grip
strength, pain perception, landing foot
splay and motor activity were
performed in the combined repeated
dose toxicity study with the
reproduction/developmental toxicity
screening test in rats and no adverse
effects were observed.
Immunotoxicity studies are not
available for review. However, evidence
of immunotoxicity is not observed in
the submitted studies.
In the 2-generation reproduction
toxicity study, alcohols, C2–33, manuf.
of, by-products from, overheads caused
a slight delay in sexual maturation in rat
pups. When the appropriate screening
and/or testing protocols being
considered under the Agency’s
Endocrine Disruption Screening
Program (EDSP) have been developed,
C2–33, manuf. of, by-products from,
overheads may be subjected to
additional screening and/or testing to
better characterize effects related to
endocrine disruption.
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
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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 combined repeated dose toxicity
study with the reproduction/
developmental toxicity screening test
and a 2-generation reproduction toxicity
study are considered co-critical and
these studies are selected for the chronic
dietary exposure scenario as well as the
dermal and inhalation intermediate and
long-term exposure scenarios. The
NOAELs are 500 mg/kg/day in these
studies. Effects are seen at the limit
dose, 1,000 mg/kg/day, in both studies.
Parental effects are confined to female
rats and included an increased number
of females giving birth to dead pups and
reduced body weights and/or weight
gain in F0 females during mating and in
F1 females during gestation and reduced
food consumption in the reproduction/
developmental toxicity screening test
and the 2-generation reproduction
toxicity study, respectively. Offspring
toxicity is manifested as reduced pup
viability and reduced mean delay of
vaginal opening and preputial
separation and reduced ovarian
follicles, respectively. Reproduction
toxicity is observed in the both studies
and include a lower numbers of
implantation sites and lower litter size
with correlating lower litter weight in
the F0 and F1 generations in the
reproduction/developmental toxicity
screening tests; and increased number of
females giving birth to dead pups in the
reproduction toxicity study. The
standard inter- and intra-species
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uncertainty factors of 10x are applied.
The default factor of 100% is applied for
the dermal and inhalation absorption
rates. The chronic reference dose (cRfD)
is 5.0 mg/kg/day. The level of concern
(LOC) and margin of exposure is 100.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to alcohols, C2–33, manuf. of,
by-products from, overheads, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
alcohols, C2–33, manuf. of, by-products
from, overheads in food as follows:
Dietary exposure (food and drinking
water) to alcohols, C2–33, manuf. of, byproducts from, overheads can occur
following ingestion of foods with
residues from treated crops. Because no
adverse effects attributable to a single
exposure to alcohols, C2–33, manuf. of,
by-products from, overheads are seen in
the toxicity databases, an acute dietary
risk assessment is not necessary. For the
chronic dietary risk assessment, EPA
used the Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCIDTM, Version 3.16) and 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 alcohols, C2–33,
manuf. of, by-products from, overheads.
In the absence of specific residue data,
EPA has developed an approach that
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. One
hundred percent crop treated was
assumed, default processing factors, and
tolerance-level residues for all foods. 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.
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
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requirement of a tolerance for alcohols,
C2–33, manuf. of, by-products from,
overheads, 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., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Alcohols, C2–33, manuf. of, byproducts from, overheads may be used
in inert ingredients in products that are
registered for specific uses that may
result in residential exposure, such as
pesticides used in and around the home.
The Agency conducted an assessment to
represent conservative residential
exposure by assessing alcohols, C2–33,
manuf. of, by-products from, overheads
in pesticide formulations (outdoor
scenarios) and in disinfectant-type uses
(indoor scenarios). The Agency’s
assessment of adult residential exposure
combines high end dermal and
inhalation handler exposure from
liquids/backpack sprayer/home garden
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).
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 alcohols, C2–33,
manuf. of, by-products from, overheads
to share a common mechanism of
toxicity with any other substances, and
alcohols, C2–33, manuf. of, by-products
from, overheads does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that alcohols, C2–33, manuf. of,
by-products from, overheads do not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
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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
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
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 based on the
following reasons. The toxicity database
for alcohols, C2–33, manuf. of, byproducts from, overheads contain the
following studies; combined repeated
dose toxicity study with the
reproduction/developmental toxicity
screening test in rats, 2-generation
reproduction toxicity in rats, Ames test
and micronucleus assay. No evidence of
neurotoxicity was observed in the
functional observation battery. There is
no indication of immunotoxicity in the
available studies; therefore, there is no
need to require an immunotoxicity
study. Fetal susceptibility is not
observed as fetal toxicity occurs in the
present of maternal toxicity in the
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test and the 2generation reproduction toxicity study.
In addition, the chronic reference dose
(cRfD) is protective of any observed
effects since it is based on the effects
observed in these studies. Therefore, the
Agency has concluded that reducing the
FQPA SF to 1X is appropriate.
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-,
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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, alcohols, C2–33,
manuf. of, by-products from, overheads
are 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 alcohols, C2–33,
manuf. of, by-products from, overheads
from food and water will utilize 14.1%
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).
Alcohols, C2–33, manuf. of, byproducts from, overheads are 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 alcohols, C2–33, manuf. of,
by-products from, overheads.
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 332 for adults. Adult
residential exposure combines high end
dermal and inhalation handler exposure
from liquids/backpack sprayer/home
garden with a high-end post application
dermal exposure from contact with
treated lawns. EPA has concluded the
combined short-term aggregated food,
water, and residential pesticide
exposures result in an aggregate MOE of
309 for children. Children’s residential
exposure includes total exposures
associated with contact with treated
lawns (dermal and hand-to-mouth
exposures). Because EPA’s level of
concern for alcohols, C2–33, manuf. of,
by-products from, overheads is an MOE
of 100 or below, these MOEs are not of
concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
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residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Alcohols, C2–33, manuf. of, byproducts from, overheads are 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 alcohols, C2–33,
manuf. of, by-products from, overheads.
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 1105 for adults.
Adult residential exposure combines
liquids/backpack sprayer/home garden
use with a high-end post application
dermal exposure from contact with
treated lawns. EPA has concluded the
combined intermediate-term aggregated
food, water, and residential exposures
result in an aggregate MOE of 431 for
children. Because EPA’s level of
concern for alcohols, C2–33, manuf. of,
by-products from, overheads is an MOE
of 100 or below, these MOEs are not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
mutagenicity, alcohols, C2–33, manuf. of,
by-products from, overheads are 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 alcohols,
C2–33, manuf. of, by-products from,
overheads residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. Response to Comments
One commenter believed that all
analyses should be provided on
alcohols, C2–33, manuf. of, by-products
from, overheads residues prior to its use
as an inert ingredient in solvents and
that no tolerance or tolerance exemption
should be allowed. Under the existing
legal framework provided by FFDCA
section 408, EPA is authorized to
establish pesticide chemical tolerances
or exemptions where persons seeking
PO 00000
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such tolerances or exemptions have
demonstrated that the pesticide
chemical meets the safety standard
imposed by the statute. EPA has
sufficient data to evaluate the potential
adverse effects from exposure to this
pesticide chemical, including data on
the potential for long-term effects. After
evaluating that data and other
information, EPA has determined that
the tolerance exemptions for this
chemical are safe. The commenter has
provided no other information for the
Agency to consider in making its safety
determination.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under residues of alcohols, C2–33, manuf.
of, by-products from, overheads (CAS
Reg. No. 876065–86–0) when used as an
inert ingredient (solvent) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest under 40 CFR 180.910 and
applied to animals under 40 CFR
180.930.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions
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
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Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Rules and Regulations
under FFDCA section 408(d), such as
the exemptions 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
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 21, 2019.
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:
■
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).
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredient ‘‘Alcohols, C2–33, manuf.
of, by-products from, overheads (CAS
Reg. No. 876065–86–0)’’ to the table to
read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
Alcohols, C2–33, manuf. of, by-products from, overheads (CAS Reg. No. 876065–86–0) ..........
*
.....................................
*
*
*
3. In § 180.930, add alphabetically the
inert ingredient ‘‘Alcohols, C2–33, manuf.
of, by-products from, overheads (CAS
■
*
*
Reg. No. 876065–86–0)’’ to the table to
read as follows:
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
*
*
*
*
*
Alcohols, C2–33, manuf. of, by-products from, overheads (CAS Reg. No. 876065–86–0) ..........
*
.....................................
*
[FR Doc. 2019–19398 Filed 9–6–19; 8:45 am]
*
ACTION:
*
Notification of availability.
BILLING CODE 6560–50–P
The Coast Guard announces
the availability of the Merchant Mariner
Medical Manual, Commandant
Instruction Manual (COMDTINST
M16721.48). The guidance in this
Manual should assist medical
practitioners, the maritime industry,
individual mariners, and Coast Guard
personnel in evaluating a mariner
applicant’s physical and medical status
to meet the requirements of the
merchant mariner medical certificate.
This Manual incorporates and
consolidates prior guidance on the
SUMMARY:
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
46 CFR Part 10
[Docket No. USCG–2018–0041]
COMDTINST M16721.48 Merchant
Mariner Medical Manual
AGENCY:
Coast Guard, DHS.
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*
Solvent.
*
Limits
*
*
Uses
Inert ingredients
*
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List of Subjects in 40 CFR Part 180
*
Uses
*
*
Solvent.
*
medical evaluation of merchant
mariners contained in several Coast
Guard documents. The Manual includes
guidance on the medical certificate and
related processes, including procedures
for application, issuance, and
cancellation of the medical certificate.
The Merchant Mariner Medical
Manual, COMDTINST M16721.4, is
effective on September 9, 2019.
DATES:
For
information about this document or to
suggest changes, call or email Adrienne
Buggs, M.D., United States Coast Guard,
Office of Merchant Mariner
FOR FURTHER INFORMATION CONTACT:
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Agencies
[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47136-47141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19398]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0203; FRL-9998-48]
Alcohols, C2-33, Manuf. of By-Products From, Overheads; 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 alcohols, C2-33, manuf. of,
by-products from, overheads when used as an inert ingredient (solvent)
in pesticide products applied to growing crops and raw agricultural
commodities after harvest, and to animals. Spring Trading Company, on
behalf of Sasol Chemicals (USA) LLC, submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of alcohols, C2-33, manuf. of, by-products
from, overheads when used in accordance with the terms of those
exemptions.
DATES: This regulation is effective September 9, 2019. Objections and
requests for hearings must be received on or before November 8, 2019,
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-2018-0203, 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 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: [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
[[Page 47137]]
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-2018-0203 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
November 8, 2019. 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-2018-0203, 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 August 24, 2018 (83 FR 42818) (FRL-9982-
37), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11098) by
Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354) on
behalf of Sasol Chemicals (USA) LLC (12120 Wickchester Lane, Houston,
TX 77079). The petition requested that the 40 CFR be amended by
establishing exemptions from the requirement of a tolerance for
residues of alcohols, C2-33, manuf. of, by-products from,
overheads (CAS Reg. No. 876065-86-0) when used as an inert ingredient
(solvent) in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest under 40 CFR 180.910 and to
animals under 40 CFR 180.930. That document referenced a summary of the
petition prepared by Spring Trading Company on behalf of Sasol
Chemicals (USA) LLC, the petitioner, which is available in the docket,
https://www.regulations.gov. One relevant comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
V.B.
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(c)(2)(B) requires EPA, in making a
determination of safety for the exemption, to take into account the
factors in subparagraphs (b)(2)(C) and (D). Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .''
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 alcohols, C2-33,
manuf. of, by-products from, overheads including exposure resulting
from the exemption established by this action. EPA's assessment of
exposures and risks associated with alcohols, C2-33, manuf.
of, by-products from, overheads follow.
[[Page 47138]]
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 alcohols, C2-33, manuf. of,
by-products from, overheads 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.
C2-33 manuf. of, by-products from, overheads are the by-
products obtained as solvent stripper overheads after removal of non-
alkoxide components during the manufacture of alcohols from ethylene by
the Ziegler process. It consists predominantly of paraffins, olefins,
naphthenes and esters having carbon numbers in the range
C2-34 and melting in the range of approximately -17.5 [deg]C
to -4.1 [deg]C.
The acute oral and dermal toxicity is low in rats treated with
alcohols, C2-33, manuf. of, by-products from, overheads; the
lethal dose, LD50 is >2,000 milligrams/kilogram (mg/kg). It
is not a dermal sensitizer in the guinea pig. Acute inhalation toxicity
studies are not available for review. Alcohols, C2-33,
manuf. of, by-products from, overheads are not a skin or eye irritant
in rabbits.
Three repeated dose studies via oral exposure are available with
alcohols, C2-33, manuf. of, by-products from, overheads in
rats: A 14-day range finding toxicity study; a combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
tests in rats; and a 2-generation toxicity study in rats. Following 14
days of oral exposure to alcohols, C2-33, manuf. of, by-
products from, overheads in rats, no toxicity is seen at 1,000 mg/kg/
day. In the combined repeated dose toxicity study with the
reproduction/developmental toxicity screening tests in rats, parental
and offspring toxicities are observed at 1,000 mg/kg/day. Parental and
reproduction toxicities are manifested as an increased number of
females giving birth to dead pups and offspring toxicity is manifested
as reduced pup viability. The NOAELs are 500 mg/kg/day. In the 2-
generation reproduction toxicity study, offspring toxicity is
manifested as reduced pup viability. The NOAEL is 500 mg/kg/day. In a
reproduction toxicity study in rats, parental, offspring and
reproduction toxicities are seen at 1,000 mg/kg/day. Parental toxicity
manifests as reduced body weights and/or weight gain in F0
females during mating and in F1 females during gestation and
reduced food consumption, offspring toxicity manifests as delayed
vaginal opening and preputial separation and reduced ovarian follicles
and reproduction toxicity manifests as lower numbers of implantation
sites and lower litter size with correlating lower litter weight noted
in both generations. The NOAELs are 500 mg/kg/day. Increase fetal
susceptibility is not observed as offspring toxicity occurs in the
presence of maternal toxicity. The combined repeated dose toxicity
studies with the reproduction/developmental toxicity screening tests
and the 2-generation toxicity study in rats are considered co-critical,
the chronic reference dose (cRfD) of 5.0 mg/kg/day is based on these
studies and is protective of the effects observed at 1,000 mg/kg/day.
Carcinogenicity studies with alcohols, C2-33, manuf. of,
by-products from, overheads are not available. However, based on the
lack of mutagenicity in the Ames test, alcohols, C2-33,
manuf. of, by-products are not expected to be carcinogenic.
Neurotoxicity studies are not available for review. However,
detailed functional observations (FOB), grip strength, pain perception,
landing foot splay and motor activity were performed in the combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test in rats and no adverse effects were observed.
Immunotoxicity studies are not available for review. However,
evidence of immunotoxicity is not observed in the submitted studies.
In the 2-generation reproduction toxicity study, alcohols,
C2-33, manuf. of, by-products from, overheads caused a
slight delay in sexual maturation in rat pups. When the appropriate
screening and/or testing protocols being considered under the Agency's
Endocrine Disruption Screening Program (EDSP) have been developed,
C2-33, manuf. of, by-products from, overheads may be
subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.
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 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test and a 2-generation reproduction
toxicity study are considered co-critical and these studies are
selected for the chronic dietary exposure scenario as well as the
dermal and inhalation intermediate and long-term exposure scenarios.
The NOAELs are 500 mg/kg/day in these studies. Effects are seen at the
limit dose, 1,000 mg/kg/day, in both studies. Parental effects are
confined to female rats and included an increased number of females
giving birth to dead pups and reduced body weights and/or weight gain
in F0 females during mating and in F1 females
during gestation and reduced food consumption in the reproduction/
developmental toxicity screening test and the 2-generation reproduction
toxicity study, respectively. Offspring toxicity is manifested as
reduced pup viability and reduced mean delay of vaginal opening and
preputial separation and reduced ovarian follicles, respectively.
Reproduction toxicity is observed in the both studies and include a
lower numbers of implantation sites and lower litter size with
correlating lower litter weight in the F0 and F1
generations in the reproduction/developmental toxicity screening tests;
and increased number of females giving birth to dead pups in the
reproduction toxicity study. The standard inter- and intra-species
[[Page 47139]]
uncertainty factors of 10x are applied. The default factor of 100% is
applied for the dermal and inhalation absorption rates. The chronic
reference dose (cRfD) is 5.0 mg/kg/day. The level of concern (LOC) and
margin of exposure is 100.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to alcohols, C2-33, manuf. of, by-products from,
overheads, EPA considered exposure under the proposed exemption from
the requirement of a tolerance. EPA assessed dietary exposures from
alcohols, C2-33, manuf. of, by-products from, overheads in
food as follows:
Dietary exposure (food and drinking water) to alcohols,
C2-33, manuf. of, by-products from, overheads can occur
following ingestion of foods with residues from treated crops. Because
no adverse effects attributable to a single exposure to alcohols,
C2-33, manuf. of, by-products from, overheads are seen in
the toxicity databases, an acute dietary risk assessment is not
necessary. For the chronic dietary risk assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM, Version 3.16) and 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 alcohols, C2-33, manuf. of,
by-products from, overheads. In the absence of specific residue data,
EPA has developed an approach that 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. One hundred percent crop treated was assumed, default
processing factors, and tolerance-level residues for all foods. 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.
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 alcohols,
C2-33, manuf. of, by-products from, overheads, 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, and hard surface disinfection on walls, floors, tables).
Alcohols, C2-33, manuf. of, by-products from, overheads
may be used in inert ingredients in products that are registered for
specific uses that may result in residential exposure, such as
pesticides used in and around the home. The Agency conducted an
assessment to represent conservative residential exposure by assessing
alcohols, C2-33, manuf. of, by-products from, overheads in
pesticide formulations (outdoor scenarios) and in disinfectant-type
uses (indoor scenarios). The Agency's assessment of adult residential
exposure combines high end dermal and inhalation handler exposure from
liquids/backpack sprayer/home garden 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).
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 alcohols, C2-33, manuf. of, by-
products from, overheads to share a common mechanism of toxicity with
any other substances, and alcohols, C2-33, manuf. of, by-
products from, overheads does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that alcohols, C2-33,
manuf. of, by-products from, overheads 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. 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 based on the following reasons. The toxicity database for
alcohols, C2-33, manuf. of, by-products from, overheads
contain the following studies; combined repeated dose toxicity study
with the reproduction/developmental toxicity screening test in rats, 2-
generation reproduction toxicity in rats, Ames test and micronucleus
assay. No evidence of neurotoxicity was observed in the functional
observation battery. There is no indication of immunotoxicity in the
available studies; therefore, there is no need to require an
immunotoxicity study. Fetal susceptibility is not observed as fetal
toxicity occurs in the present of maternal toxicity in the combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test and the 2-generation reproduction toxicity
study. In addition, the chronic reference dose (cRfD) is protective of
any observed effects since it is based on the effects observed in these
studies. Therefore, the Agency has concluded that reducing the FQPA SF
to 1X is appropriate.
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-,
[[Page 47140]]
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,
alcohols, C2-33, manuf. of, by-products from, overheads are
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
alcohols, C2-33, manuf. of, by-products from, overheads from
food and water will utilize 14.1% 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).
Alcohols, C2-33, manuf. of, by-products from, overheads
are 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 alcohols, C2-33, manuf. of, by-
products from, overheads.
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 332 for adults.
Adult residential exposure combines high end dermal and inhalation
handler exposure from liquids/backpack sprayer/home garden with a high-
end post application dermal exposure from contact with treated lawns.
EPA has concluded the combined short-term aggregated food, water, and
residential pesticide exposures result in an aggregate MOE of 309 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). Because EPA's level of concern for alcohols,
C2-33, manuf. of, by-products from, overheads is an 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).
Alcohols, C2-33, manuf. of, by-products from, overheads
are 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 alcohols, C2-33,
manuf. of, by-products from, overheads.
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 1105 for adults. Adult residential exposure combines
liquids/backpack sprayer/home garden use with a high-end post
application dermal exposure from contact with treated lawns. EPA has
concluded the combined intermediate-term aggregated food, water, and
residential exposures result in an aggregate MOE of 431 for children.
Because EPA's level of concern for alcohols, C2-33, manuf.
of, by-products from, overheads is an MOE of 100 or below, these MOEs
are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
mutagenicity, alcohols, C2-33, manuf. of, by-products from,
overheads are 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 alcohols, C2-33, manuf. of, by-products from,
overheads residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Response to Comments
One commenter believed that all analyses should be provided on
alcohols, C2-33, manuf. of, by-products from, overheads
residues prior to its use as an inert ingredient in solvents and that
no tolerance or tolerance exemption should be allowed. Under the
existing legal framework provided by FFDCA section 408, EPA is
authorized to establish pesticide chemical tolerances or exemptions
where persons seeking such tolerances or exemptions have demonstrated
that the pesticide chemical meets the safety standard imposed by the
statute. EPA has sufficient data to evaluate the potential adverse
effects from exposure to this pesticide chemical, including data on the
potential for long-term effects. After evaluating that data and other
information, EPA has determined that the tolerance exemptions for this
chemical are safe. The commenter has provided no other information for
the Agency to consider in making its safety determination.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under residues of alcohols, C2-33, manuf. of,
by-products from, overheads (CAS Reg. No. 876065-86-0) when used as an
inert ingredient (solvent) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest under 40 CFR
180.910 and applied to animals under 40 CFR 180.930.
VII. Statutory and Executive Order Reviews
This action establishes exemptions 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
[[Page 47141]]
under FFDCA section 408(d), such as the exemptions 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: August 21, 2019.
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
``Alcohols, C2-33, manuf. of, by-products from, overheads
(CAS Reg. No. 876065-86-0)'' to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest;
exemptions from the requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Alcohols, C2 33, manuf. of, by-products from, ............................ Solvent.
overheads (CAS Reg. No. 876065-86-0).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
3. In Sec. 180.930, add alphabetically the inert ingredient
``Alcohols, C2-33, manuf. of, by-products from, overheads
(CAS Reg. No. 876065-86-0)'' to the table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Alcohols, C2 33, manuf. of, by-products from, ............................ Solvent.
overheads (CAS Reg. No. 876065-86-0).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2019-19398 Filed 9-6-19; 8:45 am]
BILLING CODE 6560-50-P