[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Rules and Regulations]
[Pages 41411-41416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13012]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0098; FRL-10007-73]


Tetraethyl Orthosilicate; 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 tetraethyl orthosilicate when used as an 
inert ingredient (binder) in pesticides applied to growing crops and 
raw agricultural commodities after harvest and pesticides 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 tetraethyl orthosilicate when used in accordance with 
the terms of this exemption.

DATES: This regulation is effective July 10, 2020. Objections and 
requests for hearings must be received on or before September 8, 2020, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID)

[[Page 41412]]

number EPA-HQ-OPP-2019-0098, 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 note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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-2019-0098 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 
September 8, 2020. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0098, 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-11247) by 
Exponent on behalf of LNouvel, Inc. 4657 Courtyard Trail, Plano, TX 
75024. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be 
amended by establishing exemptions from the requirement of a tolerance 
for residues of tetraethyl orthosilicate (CAS Reg. No. 78-10-4) when 
used as an inert ingredient (binder) in pesticide formulations applied 
to growing crops or to raw agricultural commodities after harvest and 
applied to animals with a limitation of 5% by weight in pesticide 
formulations. 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.
    Based upon review of the data supporting the petition, EPA has 
decreased the limitation from 5% to 2% by weight in pesticide 
formulations due to risk concerns from aggregate exposure to tetraethyl 
orthosilicate at the requested 5% limitation. This limitation is based 
on the Agency's risk assessment which can be found at http://www.regulations.gov in document ``Tetraethyl Orthosilicate; Human 
Health Risk Assessment and Ecological Effects Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as an 
Inert Ingredient in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2019-0098.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA

[[Page 41413]]

defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings but does 
not include occupational exposure. Section 408(b)(2)(C) of FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue . . . .''. EPA establishes exemptions from the 
requirement of a tolerance only in those cases where it can be clearly 
demonstrated that the risks from aggregate exposure to pesticide 
chemical residues under reasonably foreseeable circumstances will pose 
no appreciable risks to human health. In order to determine the risks 
from aggregate exposure to pesticide inert ingredients, the Agency 
considers the toxicity of the inert in conjunction with possible 
exposure to residues of the inert ingredient through food, drinking 
water, and through other exposures that occur as a result of pesticide 
use in residential settings. If EPA is able to determine that a finite 
tolerance is not necessary to ensure that there is a reasonable 
certainty that no harm will result from aggregate exposure to the inert 
ingredient, an exemption from the requirement of a tolerance may be 
established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for tetraethyl orthosilicate 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 
tetraethyl orthosilicate 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 tetraethyl orthosilicate as well as 
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies unit can be 
found at http://www.regulations.gov in the document Tetraethyl 
Orthosilicate; Human Health Risk Assessment and Ecological Effects 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations at 
page 8 in docket ID number EPA-HQ-OPP-2019-0098.

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.
    Based on the effects in the combined repeated dose and reproductive 
and developmental screening study, the POD for chronic effects is the 
NOAEL of 10 mg/kg/day (based on kidney effects in male rats at a LOAEL 
of 50 mg/kg/day). The standard uncertainty factors are applied to 
account for interspecies (10X) and intraspecies (10X) variations. The 
FQPA safety factor for the protection of infants and children is 
reduced to 1X. This results in a level of concern (LOC) for the margin 
of exposure (MOE) of 100. The chronic population adjusted dose (cPAD) 
is 0.1 mg/kg/day and this value is used for all exposure scenarios. A 
default value of 100% absorption was used for the dermal and inhalation 
exposure scenario absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tetraethyl orthosilicate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from tetraethyl orthosilicate in food as follows:
    In conducting the chronic dietary exposure assessment, EPA used 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no 
residue data were submitted for tetraethyl orthosilicate. In the 
absence of specific residue data, EPA has developed an approach which 
uses surrogate information to derive upper bound exposure estimates for 
the subject inert ingredient. Upper bound exposure estimates are based 
on the highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738 and can be 
found at http://www.regulations.gov in the document Tetraethyl 
Orthosilicate; Human Health Risk Assessment and Ecological Effects 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations at 
page 14 in docket ID number EPA-HQ-OPP-2019-0098
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support

[[Page 41414]]

this request for an exemption from the requirement of a tolerance for 
tetraethyl orthosilicate, 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).
    Tetraethyl orthosilicate may be used as an inert ingredient in 
products that are registered for specific uses that may result in 
residential exposure. A screening level residential exposure and risk 
assessment was completed for products containing tetraethyl 
orthosilicate as an inert ingredient. The Agency selected 
representative scenarios, based on end-use product application methods 
and labeled application rates. The Agency conducted an assessment to 
represent worst-case residential exposure by assessing tetraethyl 
orthosilicate in pesticide formulations (outdoor scenarios) and 
tetraethyl orthosilicate in disinfectant-type uses (indoor scenarios). 
The Agency assessed the disinfectant-type products containing 
tetraethyl orthosilicate using exposure scenarios used by OPP's 
Antimicrobials Division to represent worst-case indoor residential 
handler exposure. Further details of the residential exposure and risk 
analysis can be found at http://www.regulations.gov in the memorandum 
entitled: ``JITF Inert Ingredients. Residential and Occupational 
Exposure Assessment Algorithms and Assumptions Appendix for the Human 
Health Risk Assessments to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 
Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-
HQ-OPP-2008-0710.
    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 
tetraethyl orthosilicate to share a common mechanism of toxicity with 
any other substances, and tetraethyl orthosilicate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tetraethyl orthosilicate 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. The Agency has concluded 
that there is reliable data to determine the infants and children will 
be safe if the FQPA SF of 10X is reduced to 1X for the assessment of 
all exposure scenarios. The toxicity database for tetraethyl 
orthosilicate contains subchronic, developmental, reproduction and 
mutagenicity studies. There is no indication of immunotoxicity or 
neurotoxicity in the available studies; therefore, there is no need to 
require an immunotoxicity or neurotoxicity study. No fetal 
susceptibility is observed in developmental toxicity studies in the rat 
and rabbit or the 2-generation reproduction toxicity study. Neither 
maternal, offspring nor reproduction toxicity is observed in any of the 
studies.
    3. Conclusion. Based on the adequacy of the toxicity database, the 
conservative nature of the exposure assessment and the lack of concern 
for prenatal and postnatal sensitivity, the Agency has concluded that 
there is reliable data to determine that infants and children will be 
safe if the FQPA SF of 10X is reduced to 1X for all exposure scenarios.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on tetraethyl 
orthosilicate with an additional limit of 2% is pesticide formulations, 
EPA has determined that there is a reasonable certainty that no harm to 
any population subgroup will result from aggregate exposure to 
tetraethyl orthosilicate under reasonably foreseeable circumstances. 
Therefore, the establishment of an exemption from tolerance under 40 
CFR 180.910 and 180.930 for residues of tetraethyl orthosilicate when 
used as an inert ingredient in pesticide formulations applied as a 
binder and not to exceed 2% of the formulation is safe under FFDCA 
section 408.
    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, 
tetraethyl orthosilicate 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 
tetraethyl orthosilicate from food and water will utilize 28.2% of the 
cPAD for children 1 to 2 years old, the population group receiving the 
greatest exposure. Based on the explanation in this unit, regarding 
residential use patterns, chronic residential exposure to residues of 
tetraethyl orthosilicate is not expected.
    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).
    Tetraethyl orthosilicate 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 tetraethyl orthosilicate.
    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 145 for both 
adult males and females and 125 for children. Because EPA's level of 
concern for tetraethyl orthosilicate is a MOE of 100 or below, these 
MOEs are not of concern.

[[Page 41415]]

    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).
    Tetraethyl orthosilicate is currently used as an inert ingredient 
in pesticide products that are registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to tetraethyl 
orthosilicate.
    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 595 for adult males and females and 163 for children. 
Because EPA's level of concern for tetraethyl orthosilicate is a MOE of 
100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
structural alerts in the Derek expert-based knowledge analysis 
regarding carcinogenicity, tetraethyl orthosilicate 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 tetraethyl orthosilicate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromotography 
using electron capture detection) is available to enforce the tolerance 
exemption expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

B. Revisions to Petitioned-for Tolerances

    The petition requested exemptions with a limitation of 50,000 ppm 
of tetraethyl orthosilicate in pesticide formulations. This is 
equivalent to 5% of the formulation. At that level, EPA's assessment 
indicated risks of concern from aggregate exposures to tetraethyl 
orthosilicate. EPA proposed a 2% limitation to the petitioner, to which 
the petitioner agreed. At that level, EPA's assessment indicates that 
risks are below the Agency's level of concern.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 180.930 for tetraethyl 
orthosilicate (CAS Reg. No. 78-10-4) when used as an inert ingredient 
(binder) in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest and applied to animals with a 
limitation of 2% by weight in the pesticide formulation.

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 under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 2, 2020.
Michael Goodis,
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 amend Table 1 by adding alphabetically under 
``Inert ingredients'' the term ``Tetraethyl orthosilicate (CAS Reg. No. 
78-10-4)'' to read as follows:

[[Page 41416]]

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                                * * * * *
Tetraethyl orthosilicate (CAS     Not to exceed 2%    Binder.
 Reg. No. 78-10-4).                by weight of
                                   pesticide
                                   formulations.
 
                                * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, amend the table by adding alphabetically under 
``Inert Ingredients'' the term ``Tetraethyl orthosilicate (CAS Reg. No. 
78-10-4)'' to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                                * * * * *
Tetraethyl orthosilicate (CAS     Not to exceed 2%    Binder.
 Reg. No. 78-10-4).                by weight of
                                   pesticide
                                   formulations.
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2020-13012 Filed 7-9-20; 8:45 am]
BILLING CODE 6560-50-P


