[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Rules and Regulations]
[Pages 25531-25535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07192]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0321; FRL-11813-01-OCSPP]


Silane, Hexadecyltrimethoxy-, Hydrolysis Products With Silica in 
Pesticide Formulations; Pesticide Tolerance Exemption

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 silane, hexadecyltrimethoxy-, hydrolysis 
products with silica (CAS Reg. No. 199876-45-4) when used as an inert 
ingredient (Pickering emulsion) on growing crops and raw agricultural 
commodities pre- and post-harvest at no more than 0.6% by weight of the 
pesticide formulation. Evonik Corporation, 299 Jefferson Road, 
Parsippany, NJ 07054 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 silane, hexadecyltrimethoxy-, hydrolysis products with 
silica, when used in accordance with the terms of this exemption.

[[Page 25532]]


DATES: This regulation is effective April 11, 2024. Objections and 
requests for hearings must be received on or before June 10, 2024 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-2021-0321, is available at 
https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in-person, 
is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. It may be of 
specific interest to persons who are an agricultural producer, food 
manufacturer, or pesticide manufacturer identified under North American 
Industrial Classification System (NAICS) codes 111, 112, 311, and 
32532. The NAICS codes are provided to assist in determining interest. 
However, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is the Agency's authority for taking this action?

    EPA is taking this action pursuant to the authority in section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0321 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 
June 10, 2024. 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-2021-0321, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 1, 2021 (86 FR 29229 (FRL-10023-
95)), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11409) by 
Evonik Corporation, 299 Jefferson Road, Parsippany, NJ 07054. The 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of silane, 
hexadecyltrimethoxy-, hydrolysis products with silica (CAS Reg. No. 
199876-45-4) when used as an inert ingredient (stabilizing emulsion) 
(Pickering emulsion) in pesticide formulations under 40 CFR 180.910 and 
180.950 at no more than 0.6% by weight of the pesticide formulation 
(the petitioner has since withdrawn the portion of the petition 
requesting an exemption under 40 CFR 180.950). That document referenced 
a summary of the petition prepared by Evonik Corporation, 299 Jefferson 
Road, Parsippany, NJ 07054, the petitioner, which is available in the 
docket, https://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    FFDCA section 408(c)(2)(A)(i) 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.'' FFDCA section 408(c)(2)(A)(ii) 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. When making a safety determination for an 
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B) 
directs EPA to consider the considerations in FFDCA section 
408(b)(2)(C) and (D). FFDCA section 408(b)(2)(C) 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. . . .'' FFDCA section 408(b)(2)(D) lists other factors for EPA 
consideration making safety determinations, e.g., the validity, 
completeness, and reliability of available data, nature of toxic 
effects, available information concerning the cumulative effects of the 
pesticide chemical and other substances with a

[[Page 25533]]

common mechanism of toxicity, and available information concerning 
aggregate exposure levels to the pesticide chemical and other related 
substances, among others.
    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 harm 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 silane, hexadecyltrimethoxy-, 
hydrolysis products with silica including exposure resulting from the 
exemption established by this action. EPA's assessment of exposures and 
risks associated with silane, hexadecyltrimethoxy-, hydrolysis products 
with silica 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 silane, hexadecyltrimethoxy-, 
hydrolysis products with silica 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.
    The toxicological database of silane, hexadecyltrimethoxy-, 
hydrolysis products with silica is supported by data regarding 
surrogate synthetic amorphous silica (SAS) compounds. EPA has 
determined that it is appropriate to bridge SAS data to assess silane, 
hexadecyltrimethoxy-, hydrolysis products with silica compounds due to 
similarities in structure and physico-chemical properties.
    Silane, hexadecyltrimethoxy-, hydrolysis products with silica 
exhibits low levels of acute toxicity via the oral route of exposure. 
It is not a skin irritant or a skin sensitizer, and it is not 
irritating to the eyes. Silane, hexadecyltrimethoxy-, hydrolysis 
products with silica is anticipated to have low dermal and inhalation 
toxicity based on studies on surrogate chemicals.
    The repeated-dose toxicity for silane, hexadecyltrimethoxy-, 
hydrolysis products with silica is low. No adverse effects were 
observed in a 90-day oral rat study or in a developmental toxicity 
study in rats up to the limit dose.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The available toxicity studies indicate that silane, 
hexadecyltrimethoxy-, hydrolysis products with silica has low overall 
toxicity following acute and repeated dosing. No adverse effects were 
reported in subchronic or developmental toxicity studies. Furthermore, 
concern for carcinogenicity is low, based on negative results in 
mutagenicity studies, and the lack of adverse effects in a chronic 
study with an SAS surrogate. Therefore, based on the low toxicity of 
silane, hexadecyltrimethoxy-, hydrolysis products with silica, no 
endpoint of concern was identified for oral, dermal or inhalation 
exposure assessments, and a quantitative risk assessment is not 
necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to silane, hexadecyltrimethoxy-, hydrolysis products with 
silica, EPA considered exposure under the proposed exemption from the 
requirement of a tolerance. EPA assessed dietary exposures from silane, 
hexadecyltrimethoxy-, hydrolysis products with silica in food as 
follows:
    Dietary exposure (food and drinking water) to silane, 
hexadecyltrimethoxy-, hydrolysis products with silica may occur 
following ingestion of foods with residues from their use in accordance 
with this exemption. However, a quantitative dietary exposure 
assessment was not conducted since a toxicological endpoint for risk 
assessment was not identified.
    2. 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).
    Silane, hexadecyltrimethoxy-, hydrolysis products with silica may 
be present in pesticide and non-pesticide products that may be used in 
and around the home. However, a quantitative residential exposure 
assessment was not conducted since a toxicological endpoint for risk 
assessment was not identified.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. FFDCA section 408(b)(2)(D)(v) 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.''
    Based on the lack of toxicity in the available database, EPA has 
not found silane, hexadecyltrimethoxy-,

[[Page 25534]]

hydrolysis products with silica to share a common mechanism of toxicity 
with any other substances, and silane, hexadecyltrimethoxy-, hydrolysis 
products with silica does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
exemption, therefore, EPA has assumed that silane, hexadecyltrimethoxy-
, hydrolysis products with silica does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    FFDCA section 408(b)(2)(C) 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 Food Quality Protection Act 
(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.
    Based on an assessment of silane, hexadecyltrimethoxy-, hydrolysis 
products with silica EPA has concluded that there are no toxicological 
endpoints of concern for the U.S. population, including infants and 
children. Because there are no threshold effects associated with 
silane, hexadecyltrimethoxy-, hydrolysis products with silica, EPA 
conducted a qualitative assessment. As part of that assessment, the 
Agency did not use safety factors for assessing risk, and no additional 
safety factor is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, 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 silane, hexadecyltrimethoxy-, hydrolysis products with 
silica residues.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
silane, hexadecyltrimethoxy-, hydrolysis products with silica (CAS Reg. 
No. 199876-45-4) in or on any food commodities. EPA is establishing a 
limitation on the amount of silane, hexadecyltrimethoxy-, hydrolysis 
products with silica that may be used in pesticide formulations applied 
pre-harvest. This limitation will be enforced through the pesticide 
registration process under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any 
pesticide formulation for food use that exceeds 0.6% silane, 
hexadecyltrimethoxy-, hydrolysis products with silica (CAS Reg. No. 
199876-45-4) in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of silane, hexadecyltrimethoxy-, hydrolysis 
products with silica (CAS Reg. No. 199876-45-4) when used as an inert 
ingredient (Pickering emulsion) in pesticide formulations applied to 
growing crops or raw agricultural commodities pre- and post-harvest 
under 40 CFR 180.910 at no more than 0.6% by weight of 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). 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 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 (CRA)

    Pursuant to the CRA, 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

[[Page 25535]]

and pests, Reporting and recordkeeping requirements.

    Dated: March 29, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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 to 180.910 by adding, in 
alphabetical order, an entry for ``Silane, hexadecyltrimethoxy-, 
hydrolysis products with silica (CAS Reg. No. 199876-45-4)'' to read as 
follows:


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

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
      Inert Ingredients                Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Silane, hexadecyltrimethoxy-,  No more than 0.6% by   Stabilizing
 hydrolysis products with       weight of the          emulsion
 silica (CAS Reg. No. 199876-   pesticide              (Pickering
 45-4).                         formulation.           emulsion).
 
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[FR Doc. 2024-07192 Filed 4-10-24; 8:45 am]
BILLING CODE 6560-50-P