Rule2024-07192
Silane, Hexadecyltrimethoxy-, Hydrolysis Products With Silica in Pesticide Formulations; Pesticide Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 11, 2024
Effective
April 11, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 71 (Thursday, April 11, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#b2e0f6f4e0fcddc6dbd1d7c1f2d7c2d39cd5ddc4"><span class="__cf_email__" data-cfemail="74263032263a1b001d171107341104155a131b02">[email protected]</span></a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
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
<a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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
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Inert Ingredients Limits Uses
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* * * * * * *
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
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