Rule2022-05661
Zinc Stearate; 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
March 17, 2022
Effective
March 17, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of zinc stearate (CAS No. 557-05-1) when used as an inert ingredient (lubricant) in pesticide formulations at rates of no more than 6 percent by weight of the formulation in pre- and post-harvest applications to crops. Pyxis Regulatory Consulting, Inc., on behalf of UPL NA Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of zinc stearate (CAS No. 557-05-1) on food or feed commodities when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 52 (Thursday, March 17, 2022)</title>
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[Federal Register Volume 87, Number 52 (Thursday, March 17, 2022)]
[Rules and Regulations]
[Pages 15093-15096]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05661]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0531; FRL-9608-01-OCSPP]
Zinc Stearate; 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 zinc stearate (CAS No. 557-05-1) when
used as an inert ingredient (lubricant) in pesticide formulations at
rates of no more than 6 percent by weight of the formulation in pre-
and post-harvest applications to crops. Pyxis Regulatory Consulting,
Inc., on behalf of UPL NA Inc., submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of zinc
stearate (CAS No. 557-05-1) on food or feed commodities when used in
accordance with this exemption.
DATES: This regulation is effective March 17, 2022. Objections and
requests for hearings must be received on or before May 16, 2022 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-2020-0531, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
Due to the public health concerns related to COVID-19, the EPA
Docket
[[Page 15094]]
Center (EPA/DC) and Reading Room is open to visitors by appointment
only. For the latest status information on EPA/DC services and access,
visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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:
<a href="/cdn-cgi/l/email-protection#a4f6e0e2f6eacbd0cdc7c1d7e4c1d4c58ac3cbd2"><span class="__cf_email__" data-cfemail="13415755415d7c677a707660537663723d747c65">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. 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-2020-0531 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
May 16, 2022. 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-2020-0531, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 December 21, 2020 (85 FR 82998) (FRL-
10016-93), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11376) filed by Pyxis Regulatory Consulting, Inc., on behalf of UPL NA
Inc. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of zinc stearate (CAS No. 557-05-1) when used as an inert
ingredient (lubricant) in fumigant pesticide formulations at rates of
no more than 6 percent by weight of the formulation when applied pre-
and post-harvest to crops. That document included a summary of the
petition prepared by the petitioner and solicited comments on the
petitioner's request. The Agency did not receive any substantive public
comments.
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 the 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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that EPA has determined 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 it 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 an exemption 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 shown 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
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
[[Page 15095]]
reviewed the available scientific data and other relevant information
in support of this action and considered its validity, completeness and
reliability and the relationship of this information 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. EPA has sufficient data to assess the
hazards of and to make a determination on aggregate exposure to zinc
stearate, including exposure resulting from the exemption established
by this action. EPA's assessment of exposures and risks associated with
zinc stearate 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 zinc stearate 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 acute toxicity of zinc stearate to mammals is low. The acute
oral LD<INF>50</INF> (lethal dose) in rats is greater than 2,000
milligrams/kilogram (mg/kg). The acute dermal LD<INF>50</INF> in
rabbits is also greater than 2,000 mg/kg, and the acute inhalation
LD<INF>50</INF> in rats is greater than 200 mg/L. Zinc stearate is not
an eye or a dermal irritant.
The repeated-dose toxicity for zinc stearate and the related
compound calcium distearate in mammals is low. No adverse effects were
observed in a 28-day rat study with zinc stearate, which also conducted
a neurobehavioral evaluation. Also, no adverse effects were observed in
a combined repeated dose with reproduction/developmental screening
study in rats with calcium distearate.
No oral chronic or carcinogenicity studies are available for zinc
stearate. However, there are no structural alerts for carcinogenicity
for zinc stearate and there were no adverse effects observed in the
available studies on related substances. There is also low concern for
mutagenicity, based on negative results in an in vitro bacterial
reverse mutation study on zinc stearate. No evidence of neurotoxicity
or immunotoxicity was observed in the available studies.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoint of concern for zinc stearate were
identified in the database.
C. Exposure Assessment
1. Dietary exposure. Although dietary exposure (food and drinking
water) may occur from the proposed uses as well as existing pesticide
inert uses (e.g., flow control agent) and non-pesticide uses (e.g.,
cosmetics, personal care, pharmaceuticals, plastics and coating
additives) of zinc stearate, no endpoint of concern was identified.
Therefore, an acute or chronic dietary exposure assessment is not
necessary for zinc stearate.
2. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure.
Residential exposure to zinc stearate may occur from existing and
proposed pesticide inert uses as well as from non-pesticide uses
(cosmetics, personal care, pharmaceuticals, plastics and coating
additives) that may be used in and around the home. However, based on
the absence of a toxicological endpoint of concern, a quantitative
assessment for residential exposure was not performed.
3. 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 or
exemption, 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, zinc stearate and its
metabolites are not expected to share a common mechanism of toxicity
with other substances. For the purposes of this action, therefore, EPA
has assumed that zinc stearate does not have a common mechanism of
toxicity with other substances.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold 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 unless EPA concludes that
a different margin of safety will be safe for infants and children.
Based on the low toxicity of zinc stearate in the available studies,
EPA has concluded that there are no toxicological endpoints of concern
for the U.S. population, including infants and children, and therefore
conducted a qualitative assessment of zinc stearate. As part of its
qualitative 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
Taking into consideration all available information on zinc
stearate, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to zinc
stearate residues. Therefore, the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.910 for residues of
zinc stearate when used as an inert ingredient (lubricant) in pesticide
formulations at rates of no more than 6 percent by weight of the
formulation in pre- and post-harvest applications to crops is safe
under FFDCA section 408.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
zinc stearate in or on any food commodities. EPA is establishing a
limitation on the amount of zinc stearate that may be used in pesticide
formulations applied pre- or post-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 6 percent zinc stearate by weight in the final pesticide
formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The Codex has not established a MRL for zinc stearate.
VIII. Conclusion
Taking into consideration all available information on zinc
stearate, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup,
[[Page 15096]]
including infants and children, will result from aggregate exposure to
zinc stearate residues. Therefore, an exemption from the requirement of
a tolerance is established under 40 CFR 180.910 for zinc stearate when
used as an inert ingredient at no more than 6 percent by weight of the
total pesticide formulation.
IX. 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). 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
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).
X. 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: March 9, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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 ``Zinc stearate (CAS Reg No. 557-05-
1)'' to reads 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
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* * * * * * *
Zinc stearate (CAS Reg No. 557- Not to exceed 6 Lubricant.
05-1). percent by weight
of fumigant
pesticide
formulation.
* * * * * * *
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[FR Doc. 2022-05661 Filed 3-16-22; 8:45 am]
BILLING CODE 6560-50-P
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