Rule2023-03831
Zein; Exemption From the Requirement of a Tolerance
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
February 27, 2023
Effective
February 27, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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 and OPP Docket is (202) 566-1744. For the latest status
information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#efbdaba9bda1809b868c8a9caf8a9f8ec1888099"><span class="__cf_email__" data-cfemail="40120406120e2f3429232533002530216e272f36">[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. 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
[[Page 12221]]
requests electronically. See <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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:
<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">https://www.epa.gov/dockets/where-send-comments-epa-dockets</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 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, <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
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
[[Page 12222]]
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 (<a href="https://precision.fda.gov/uniisearch/srs/unii/80N308T1NN">https://precision.fda.gov/uniisearch/srs/unii/80N308T1NN</a>). 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 <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>.
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 <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
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
[[Page 12223]]
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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.