Zinc Stearate; Tolerance Exemption, 15093-15096 [2022-05661]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 [www.gpo.gov]
[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 
https://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.
    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 https://www.epa.gov/dockets.

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: 
[email protected].

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 Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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.
     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/contacts.html.
    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 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 LD50 (lethal dose) in rats is greater than 2,000 
milligrams/kilogram (mg/kg). The acute dermal LD50 in 
rabbits is also greater than 2,000 mg/kg, and the acute inhalation 
LD50 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
------------------------------------------------------------------------
 
                              * * * * * * *
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