Document ID: EPA-HQ-OPP-2019-0138-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)- w-hydroxy-;
Posted Date: 2019-10-03T04:00Z

[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Rules and Regulations]
[Pages 52778-52783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20524]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0138; FRL-9999-72]

Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-; 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 poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert 
ingredient (surfactant) applied to animals. Exponent, on behalf of 
LNouvel, Inc., submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- when 
used in accordance with the terms of the exemption in EPA regulations.

DATES: This regulation is effective October 3, 2019. Objections and 
requests for hearings must be received on or before December 2, 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-2019-0138, 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

[[Page 52779]]

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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
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-2019-0138 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 
December 2, 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-2019-0138, 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 May 13, 2019 (84 FR 20843) (FRL-9991-
91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11248) by 
Exponent, on behalf of LNouvel, Inc., 4657 Courtyard Trail, Plano, TX 
75024-2114. The petition requested that 40 CFR 180.930 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy)disiloxanyl)propyl)-[omega]-hydroxy- (CAS Reg. 
No. 67674-67-3) when used as an inert ingredient in pesticide 
formulations applied to animals. That document referenced a summary of 
the petition prepared by Exponent, on behalf of LNouvel, Inc., the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(c)(2)(B) requires EPA to take into 
account the considerations set forth in section 408(b)(2)(C) and (D), 
when making this safety determination. 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

[[Page 52780]]

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 poly(oxy-1,2-ethanediyl), 
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) 
propyl)-[omega]-hydroxy- including exposure resulting from the 
exemption established by this action. EPA's assessment of exposures and 
risks associated with poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- 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.
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy exhibits 
low levels of acute toxicity. Acute studies in rats showed oral 
LD50 of >1,600 mg/kg. The dermal LD50 in rats was 
>3,200 mg/kg. No acute inhalation studies were available. Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy- is considered to be an eye 
irritant and a mild skin irritant. However, it was not found to be a 
dermal sensitizer.
    Repeat dose studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- are limited. In a combined repeated dose toxicity 
study with the reproduction/developmental toxicity screening test in 
rats, effects seen at 1,000 mg/kg/day, the highest dose tested (i.e., 
800 mg/kg/day to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy-) included decreased body weight, body weight gain, and food 
consumption and reduced body temperature in males. No developmental/
reproductive adverse effect attributed to the test substance were 
observed in the study.
    There is no evidence that exposure to poly(oxy-1,2-ethanediyl), 
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) 
propyl)-[omega]-hydroxy- suppresses or otherwise harms immune function 
in humans. No signs of neurotoxicity were reported in acute or repeat-
dose oral studies. There were also no signs of carcinogenicity in the 
database. Similarly, all tests were negative for genotoxicity and 
mutagenicity. The available data suggests that poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy- is not carcinogenic.

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.
    A summary of the toxicological endpoints for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy- used for human risk assessment 
are described in this unit. The Point of Departure (POD) for all 
durations of oral, dermal, and inhalation exposure is based on the 
NOAEL of 300 mg/kg/day and the LOAEL of 1,000 mg/kg/day based on 
decreased body weight, body weight gain, and food consumption and 
reduced body temperature in males from the combined repeated dose 
toxicity study with the reproduction/developmental toxicity screening 
test. Once corrected for the percent inert ingredient in the test 
formulation, the NOAEL was 240 mg/kg/day and the LOAEL was 800 mg/kg/
day poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-.
    A 100-fold uncertainty factor was used (10X interspecies 
extrapolation, 10X for intraspecies variability, and 1X FQPA safety 
factor (SF)). The FQPA SF is reduced to 1X because the reproductive and 
developmental toxicity database is complete and there is no evidence of 
increased risk to infants and children.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance as well as the existing tolerance exemption for this 
chemical. Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is 
currently approved as a food use inert ingredient under 40 CFR 180.910. 
EPA assessed dietary exposures from poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- in food as follows:
    Because no acute endpoint of concern was identified, a quantitative 
acute dietary exposure assessment is unnecessary. In conducting the 
chronic dietary exposure assessment using the Dietary Exposure 
Evaluation Model DEEM-FCID\TM\, Version 3.16, EPA used food consumption 
information from the U.S. Department of Agriculture's National Health 
and Nutrition Examination Survey, What we eat in America, (NHANES/
WWEIA). This dietary survey was conducted from 2003

[[Page 52781]]

to 2008. The Inert Dietary Exposure Evaluation Model (I-DEEM) is a 
highly conservative model with the assumption that the residue level of 
the inert ingredient would be no higher than the highest tolerance for 
a given commodity. Implicit in this assumption is that there would be 
similar rates of degradation between the active and inert ingredient 
(if any) and that the concentration of inert ingredient in the 
scenarios leading to these highest of tolerances would be no higher 
than the concentration of the active ingredient. The model assumes 100 
percent crop treated (PCT) for all crops and that every food eaten by a 
person each day has tolerance-level residues. This model incorporates 
all current and proposed pesticidal food uses for this inert 
ingredient.
    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 poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy-, 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). A 
review of residential products containing this inert ingredient 
revealed that it is currently used in fungicides, herbicides, and 
insecticides applied to residential settings, mainly on lawns and turf. 
In an effort to assess exposure, the EPA has conducted a conservative 
screening-level assessment using high-end exposure scenarios for 
pesticidal use on lawns/turf. For each residential scenario, short-term 
exposure for both the handler (adult) and post-application exposure 
(adult and child) is expected. Based on the use pattern (e.g., pre- and 
post-harvest uses, use on lawns), intermediate-term and long-term 
pesticidal exposures from residential uses are not expected.
    In addition to the proposed and current pesticidal uses of 
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, poly(oxy-
1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) 
oxy) disiloxanyl) propyl)-[omega]-hydroxy- is also used in various non-
pesticidal products; however, quantifiable exposure data are not 
available for these exposure scenarios.
    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 poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- to share a common mechanism of toxicity with any other 
substances, and poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at 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. A combined repeated dose 
toxicity study with a reproduction/developmental toxicity screening 
test showed no effect on reproductive parameters of fertility in the 
absence of maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is complete.
    ii. There is no indication that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- results in increased susceptibility in in utero rats 
in a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- in drinking water. EPA used similarly conservative assumptions 
to assess post-application exposure of children as well as incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy-.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking

[[Page 52782]]

water. No adverse effect resulting from a single oral exposure was 
identified and no acute dietary endpoint was selected. Therefore, 
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is not 
expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- from food 
and water will utilize 29.4% of the cPAD for children 1 to 2 years old, 
the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy- is currently used as an inert 
ingredient in pesticide products that are registered for uses that 
could result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy-.
    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 390 for adults 
and 175 for children 1 to 2 years old. Because EPA's level of concern 
for poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is a MOE 
of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). A potential intermediate-term adverse effect was identified; 
however, poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is not 
currently used as an inert ingredient in pesticide products that are 
registered for any use patterns that would result in intermediate-term 
residential exposure. Intermediate-term risk is assessed based on 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) 
disiloxanyl) propyl)-[omega]-hydroxy-.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity, poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-residues.

V. Other Considerations

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.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.930 for poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert 
ingredient (surfactant) in pesticide formulations applied to animals.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), nor is it considered a regulatory action for 
purposes of Executive Order 13771, entitled ``reducing Regulations and 
Controlling Regulatory Costs (82 FR 9339, February 3, 2017). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et 
seq.), nor does it require any special considerations under Executive 
Order 12898, entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (59 FR 
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and

[[Page 52783]]

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: September 13, 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.  180.930, add alphabetically the inert ingredient 
``Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg. 
No. 67674-67-3)'' 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
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-    ..................................  Surfactant.
 tetramethyl-1-((trimethylsilyl) oxy)
 disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg.
 No. 67674-67-3).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-20524 Filed 10-2-19; 8:45 am]
BILLING CODE 6560-50-P