[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]


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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.

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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 http://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 http://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 
http://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: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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, 
http://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 http://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 http://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 http://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