Zein; Exemption From the Requirement of a Tolerance, 12220-12224 [2023-03831]
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Rules and Regulations
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
methyl-1-propanol, minimum number
average molecular weight (in amu),
22,700’’ to read as follows:
1. The authority citation for part 180
continues to read as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In § 180.960, amend table 1 to the
section by adding, in alphabetical order,
the polymer ‘‘2-Propenoic acid,
methyl-, polymer with butyl 2propenoate and methyl 2-methyl-2propenoate compd. with 2-amino-2-
■
TABLE 1 TO § 180.960
Polymer
CAS No.
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2-Propenoic acid, methyl-, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate compd. with 2-amino-2-methyl-1propanol, minimum number average molecular weight (in amu), 22,700 .......................................................................................
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[FR Doc. 2023–03858 Filed 2–24–23; 8:45 am]
178 (see also Unit I.C. of the
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION).
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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0364; FRL–10641–01–
OCSPP]
Zein; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
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SUMMARY:
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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
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1203962–19–9
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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/202005/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-sendcomments-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.
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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.
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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
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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-observedadverse-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 foodpackaging 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://
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www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-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 nonoccupational, 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
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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-andassessing-pesticide-risks/cumulativeassessment-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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 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:
■
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
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TABLE 1 TO 180.930
Inert ingredients
Limits
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Zein (CAS Reg. No. 9010–66–6) ...........
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Not more than 10,000 ppm in the pesticide formulation ........................................
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Stabilizing agent.
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Indians, Native Hawaiians, other Native
American Pacific Islanders (including
American Samoan Natives), and Alaska
Natives.’’ ANA executes this purpose
through the provision of project-based
financial assistance to Native Americans
authorized under sections 803 and 803C
of the NAPA, as well as through
advocacy on behalf of Native Americans
within HHS and with other departments
and agencies of the Federal Government
‘‘regarding all Federal policies affecting
Native Americans,’’ under section
803B(c) of the NAPA.
[FR Doc. 2023–03831 Filed 2–24–23; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
45 CFR Part 1336
RIN 0970–AC88
Native American Programs
Goal of This Final Rule: Incorporation
of Emergency Waiver Provision
Administration for Native
Americans (ANA), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
This final rule provides a
process for ANA grant recipients to
request a waiver for part or all of their
non-Federal cost share or match (NFS)
during a budget period due to
emergency circumstances.
DATES: This rule is effective on April 28,
2023.
FOR FURTHER INFORMATION CONTACT:
Carmelia Strickland, Administration for
Native Americans, 202–401–6741. Deaf
and hearing-impaired individuals may
call the Federal Dual Party Relay
Service at 1–800–877–8339 between 8
a.m. and 7 p.m. Eastern Time.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Contents
I. Background
II. Statutory Authority
III. Discussion of Changes From the Notice of
Proposed Rulemaking to Final Rule
IV. Discussion of the Final Rule
V. Comments Received and Response
VI. Regulatory Process Matters
Paperwork Reduction Act of 1995
Regulatory Flexibility Act
Treasury and General Government
Appropriations Act of 1999
Unfunded Mandates Reform Act of 1995
Federalism Assessment Executive Order
13132
Congressional Review
Executive Orders 12866 and 13563—
Regulatory Impact Analysis
I. Background
lotter on DSK11XQN23PROD with RULES1
Native American Programs Act of 1974
The Native American Programs Act of
1974 (NAPA), Public Law 93–644, was
first enacted on January 4, 1975. The
last time substantial amendments to the
NAPA regulations were made was 1996.
Section 802 of the NAPA establishes as
its broad statutory purpose the
promotion of ‘‘the goal of economic and
social self-sufficiency for American
VerDate Sep<11>2014
18:59 Feb 24, 2023
Jkt 259001
On December 7, 2021, ANA published
a notice of proposed rulemaking
(NPRM) to update existing waiver
requirements to allow an opportunity to
request a waiver of the non-Federal cost
share (NFS) in the event of an
emergency. 86 FR 69215. The NAPA
requires applicants and recipients to
provide an NFS of 20 percent of project
costs, unless waived by the
Commissioner of ANA pursuant to
objective criteria established by
regulation. Current regulations (45 CFR
1336.50) only permit ‘‘applicants’’ to
apply for a waiver of the NFS, which
ANA has interpreted as applicants for
the initial awards and applicants for
non-competing continuation (NCC)
awards. The on-going public health
emergency has greatly impacted ANA
recipients. The pandemic has greatly
increased the risk of language and
cultural decline among Native
communities with many Elders dying
from the COVID–19 virus. As tribes
began closing their revenue-generating
businesses and other governmental
operations due to the COVID–19
pandemic, they lost income and in-kind
contributions they needed to fund
Federal projects requiring a NFS. In
addition, planned sources of match
support, such as use of tribal-owned
facilities from which to operate the
project, as part of the NFS, also
diminished. ANA’s current cost-share
waiver does not allow for a process to
address a recipient’s inability to meet
the cost-share due to an emergency in
the middle of a budget period. This final
rule adds a provision (45 CFR
1336.50(b)(2)(ii)) allowing grant
recipients to apply for an emergency
waiver within the current budget period
to remedy this burden.
II. Statutory Authority
Pursuant to 42 U.S.C. 2991b of the
NAPA, ANA is authorized to allow
applicants the ability to submit a
request for a waiver of the required 20
PO 00000
Frm 00092
Fmt 4700
Sfmt 4700
percent non-Federal cost share or
match, subject to ANA regulations.
III. Discussion of Changes From the
NPRM to Final Rule
The changes made in this final
regulation, as compared with the
proposed rule, are as follows:
1. The final rule amends the word
‘‘follow’’ to the word ‘‘following’’ in 45
CFR 1336.50(b)(2). The change fixes a
typographical error in the NPRM.
2. The final rule removes the word
‘‘temporarily’’ in 45 CFR
1336.50(b)(2)(i). The word had been
added to the regulation in the proposed
rule to indicate that applicants who
sought a waiver would have to apply for
the waiver again when applying for the
NCC award. But upon further review,
ANA believes the word adds confusion
rather than clarity. The removal does
not change ANA’s process or the
substance of the rule.
3. The final rule adds the word
‘‘recipient(s)’’ in 45 CFR 1336.50(b)(2)
and (3). The NPRM proposed to add an
option for recipients to apply for a
waiver but did not add the word
recipient to the other paragraphs that
cover waiver applications. The final rule
adds the word ‘‘recipient’’ to make clear
that these sections on waivers cover
both applicants and recipients.
4. The final rule adds text in 45 CFR
1336.50(b)(2)(i) that both an applicant
for an initial award and an applicant for
an NCC award can apply for a waiver.
The final rule adds this text to set out
explicitly ANA’s interpretation of the
current rule and the intention of the
NPRM.
5. The final rule changes the NPRM
use of the word ‘‘should’’ to ‘‘can’’ in 45
CFR 1336.50(b)(3)(ii). The current
regulations use the word ‘‘can’’ in
§ 1336.50(b)(3)(ii). Changing the word to
‘‘should’’ was a drafting error that
inadvertently changed the meaning of
one of the criteria of the waiver. ANA
never intended to change the criteria for
the waiver and the final rule ensures
that the criteria remain unchanged.
IV. Discussion of the Final Rule
This final rule makes changes to 45
CFR part 1336, subpart E, Financial
Assistance Provisions, in § 1336.50.
These changes will have no regulatory
burden impact but will provide a waiver
provision and ensure programmatic
success of American Indian, Native
Hawaiian, other Native American
Pacific Islander (including American
Samoan Natives), and Alaska Nativebased recipients.
E:\FR\FM\27FER1.SGM
27FER1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 12221]]
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
[[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 (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
[[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
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Zein (CAS Reg. No. 9010-66-6)........... Not more than 10,000 ppm in the Stabilizing agent.
pesticide formulation.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 12224]]
[FR Doc. 2023-03831 Filed 2-24-23; 8:45 am]
BILLING CODE 6560-50-P
