[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Rules and Regulations]
[Pages 12220-12224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03831]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0364; FRL-10641-01-OCSPP]


Zein; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of zein (CAS Reg. No. 9010-66-6) when used 
as an inert ingredient (stabilizing agent) in pesticide formulations 
applied to animals. The United States Department of Agriculture, Animal 
and Plant Health Inspection Service (USDA APHIS), 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 zein when used in accordance with the 
terms of the exemption.

DATES: This regulation is effective February 27, 2023. Objections and 
requests for hearings must be received on or before April 28, 2023, 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-2022-0364, 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 and OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-2875; 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. 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-2022-0364 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 
April 28, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although the Office 
of the Administrative Law Judges, which houses the Hearing Clerk, 
encourages parties to file objections and hearing

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requests electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    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-2022-0364, 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.
    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 May 20, 2022 (87 FR 30855) (FRL-9410-
13), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11660) by 
USDA APHIS, 4700 River Road, Unit 149, Riverdale, MD 20737. The 
petition requested that 40 CFR 180.930 be amended by establishing an 
exemption from the requirement of a tolerance for residues of zein (CAS 
Reg. No. 9010-66-6) when used as an inert ingredient (stabilizing 
agent) in pesticide formulations applied to animals, limited to not 
more than 10,000 ppm in the pesticide formulation. That document 
referenced a summary of the petition prepared by the USDA APHIS, 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

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA 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 section 408(b)(2)(C) and 
(D). Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or 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. . . .'' Section 408(b)(2)(D) lists other factors for 
EPA's consideration in 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 common mechanism 
of toxicity, and available information concerning aggregate exposure 
levels to the pesticide chemical and other related substances, among 
other factors.
    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 to zein, including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with zein 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 zein 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.
    There are no acute or repeated dose toxicity studies available for 
zein. However, zein is naturally occurring in food consumed by humans, 
as it is the primary storage protein in corn. Zein is a prolamine 
protein and is degraded into amino acids when consumed by mammals. Zein 
is classified as ``generally recognized as safe'' (GRAS) by the United 
States Food and Drug

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Administration (FDA) as a direct human food ingredient for use as a 
surface finishing agent (21 CFR 184.1984) and when used as a component 
of food-packaging adhesives (21 CFR 175.105). Further, zein is an 
inactive ingredient in FDA-approved oral drug tablets (https://precision.fda.gov/uniisearch/srs/unii/80N308T1NN). Also, zein is used 
as an alternative to gluten because it is not considered a major food 
allergen and not expected to result in sensitization. Although allergic 
reactions to corn can occur, the major allergen is the lipid transfer 
protein (LTP) rather than the storage protein (i.e., zein).
    Corn gluten meal, also known as corn gluten, is the principal 
protein in corn and consists of mainly zein and glutelin. Corn gluten 
meal is exempted from the requirement of a tolerance as an animal feed 
item under 40 CFR 180.950(b).
    Since zein is one of the major constituents of corn gluten meal, 
its toxicity is expected to be low, similar to that of corn gluten 
meal, due to being commonly found in food consumed by humans. Further, 
zein is expected to be of low toxicity based on its history of safe use 
as an inactive ingredient in drugs administered orally and its 
degradation into amino acids when consumed.

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.
    Zein toxicity is expected to be low, similar to that of corn gluten 
meal, because zein is commonly found in food consumed by humans and it 
is a major component of corn gluten meal. Additionally, zein is 
expected to be of low toxicity based on its history of safe use as an 
inactive ingredient in drugs administered orally and its degradation 
into amino acids when consumed. Therefore, no toxicological endpoints 
of concern were identified for zein.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to zein, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance and from existing uses. EPA 
assessed dietary exposures from zein in food as follows:
    Dietary exposure (food and drinking water) may occur from the 
current pesticidal uses of corn gluten meal as well as the proposed use 
of zein in/on animals (e.g., indirect exposure by consuming meat from 
animals treated with pesticide formulations containing zein and 
drinking water exposures). Zein will be used in pesticide products 
formulated as baits to attract feral swine only for the use in control 
programs operated by USDA APHIS Wildlife Services or persons under 
their authority. In addition, a concentration limit of 10,000 ppm 
(approximately 1% by weight) is being requested for use of zein as an 
inert ingredient in pesticide products applied to/on animals. Given the 
anticipated restricted use pattern and low concentration limit, as well 
as zein's degradation into amino acids when consumed by mammals, 
dietary exposure to zein from the proposed use is expected to be low. 
Dietary exposure may also occur from non-pesticidal exposure (e.g., 
pharmaceutical uses, consumption of corn products). 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, for lawn and garden pest control, indoor pest control, 
termiticides, flea and tick control on pets and hard surface 
disinfection on walls, floors, tables).
    A restricted use pattern is anticipated (i.e., use in feral swine 
baits). Therefore, residential exposure is not expected from this 
proposed use. Residential exposure may occur from current pesticidal 
uses of corn gluten meal and non-pesticidal uses of zein (e.g., 
pharmaceutical products). However, no toxicological endpoint of concern 
was identified. Therefore, 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, 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 zein to share a common mechanism of toxicity with any other 
substances, and zein does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
exemption, therefore, EPA has assumed that zein 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

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the 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 zein, 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 zein, EPA conducted a qualitative assessment. As part of that 
assessment, the Agency did not use safety factors for

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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 zein 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 
zein in or on any food commodities. EPA is establishing a limitation on 
the amount of zein that may be used in pesticide formulations. 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 10,000 ppm zein in the final 
pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of zein (CAS Reg. No. 9010-66-6) when used as 
an inert ingredient (stabilizing agent) in pesticide formulations 
applied to animals under 40 CFR 180.930, limited to not more than 
10,000 ppm in the pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 17, 2023.
Daniel Rosenblatt,
Acting 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.  180.930, amend table 1 to 180.930 by adding, in 
alphabetical order, an entry for ``Zein (CAS Reg. No. 9010-66-6)'' to 
read as follows:


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

* * * * *

                                               Table 1 to 180.930
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            Inert ingredients                          Limits                               Uses
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                                                  * * * * * * *
Zein (CAS Reg. No. 9010-66-6)...........  Not more than 10,000 ppm in the   Stabilizing agent.
                                           pesticide formulation.
 
                                                  * * * * * * *
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[FR Doc. 2023-03831 Filed 2-24-23; 8:45 am]
BILLING CODE 6560-50-P