Starch, 1-Octenylbutanedioate, Aluminum Salt; Dextrin, Hydrogen 1-Octenylbutanedioate; and Amylopectin, 2-Hydroxypropyl Ether, Acid-; Exemption From the Requirement of a Tolerance, 26498-26502 [2023-09090]
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Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Rules and Regulations
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).
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 25, 2023.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, amend table 1 to
180.910 by adding, in alphabetical
order, an entry for ‘‘Poly (oxy-1,2ethanediyl), a,a′-[[[4-[2-(4-methyl-2benzothiazolyl)diazenyl]
phenyl]imino]di-2,1-ethanediyl]bis[whydroxy- (CAS Reg. No. 158172–12–4)’’
to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
*
Poly (oxy-1,2-ethanediyl), a,a′-[[[4-[2-(4-methyl-2-benzothiazolyl)diazenyl]phenyl]imino]di-2,1-ethanediyl]bis[whydroxy- (CAS Reg. No. 158172–12–4).
*
........................
*
*
*
[FR Doc. 2023–09121 Filed 4–28–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0273, EPA–HQ–OPP–
2022–0841 and EPA–HQ–OPP–2022–0844;
FRL–10877–01–OCSPP]
Starch, 1-Octenylbutanedioate,
Aluminum Salt; Dextrin, Hydrogen 1Octenylbutanedioate; and
Amylopectin, 2-Hydroxypropyl Ether,
Acid-; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
This regulation establishes
exemptions from the requirement of a
tolerance for residues of starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- when used
as inert ingredients (for seed treatment
only) in pesticide formulations applied
pre-harvest. Ingredion Incorporated
submitted petitions to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of
exemptions from the requirement of a
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*
tolerance. This regulation eliminates the
need to establish maximum permissible
levels for residues of starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- when used
in accordance with the terms of the
exemptions.
This regulation is effective May
1, 2023. Objections and requests for
hearings must be received on or before
June 30, 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).
DATES:
The dockets for these
actions, identified by docket
identification (ID) numbers EPA–HQ–
OPP–2021–0273, EPA–HQ–OPP–2022–
0841 and EPA–HQ–OPP–2022–0844, are
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 the OPP
docket is (202) 566–1744. For the latest
ADDRESSES:
AGENCY:
SUMMARY:
*
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Colorant.
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status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
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).
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II. Petitions for Exemption
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.
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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 numbers EPA–HQ–
OPP–2021–0273, EPA–HQ–OPP–2022–
0841 and EPA–HQ–OPP–2022–0844 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 June 30, 2023. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID numbers EPA–HQ–OPP–
2021–0273, EPA–HQ–OPP–2022–0841
and EPA–HQ–OPP–2022–0844, 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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In the Federal Register of June 1, 2021
(86 FR 29229) (FRL–10023–95), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of pesticide petition PP IN–
11458 by Ingredion Incorporated, 5
Westbrook Corporate Center,
Westchester, IL 60154. The petition
requested that 40 CFR 180.920 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of starch, 1octenylbutanedioate, aluminum salt
(CAS Reg. No. 9087–61–0) when used as
an inert ingredient in pesticide
formulations applied ‘‘in or on raw
agricultural commodities pre-harvest
and as a seed treatment.’’ A summary of
the petition prepared by Ingredion
Incorporated is available in the docket
at https://www.regulations.gov.
Ingredion Incorporated subsequently
clarified that the word ‘‘and’’ should not
have been included in the request and
that they were requesting an exemption
under 40 CFR 180.920 for seed
treatment use only. Therefore, a use
pattern limitation for seed treatment use
is being established for this exemption.
In the Federal Register of November
17, 2022 (87 FR 68959) (FRL–9410–07–
OCSPP), EPA issued documents
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of
pesticide petitions PP IN–11699 and PP
IN–11715 by Ingredion Incorporated, 5
Westbrook Corporate Center,
Westchester, IL 60154. The petitions
requested that 40 CFR 180.920 be
amended by establishing exemptions
from the requirement of a tolerance for
residues of dextrin, hydrogen 1octenylbutanedioate (CAS Reg. No.
68070–94–0) and amylopectin, 2hydroxypropyl ether, acid- (CAS Reg.
No. 2756130–86–4) when used as inert
ingredients (for seed treatment only) in
pesticide formulations applied preharvest. Summaries of the petitions
prepared by Ingredion Incorporated are
available in the dockets at https://
www.regulations.gov.
There were no comments received in
response to the notices 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
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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
from the requirement of a tolerance,
FFDCA section 408(c)(2)(B) directs EPA
to account for 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 an
exemption and to ‘‘ensure that there is
a reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’ 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,
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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 these actions. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid-, including
exposure resulting from the exemptions
established by this action. EPA’s
assessment of exposures and risks
associated with starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- 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 starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
The toxicological database for starch,
1-octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid-, all of
which are modified starches, is
supported by data regarding
amylopectin, acid-hydrolyzed, 1octenylbutanedioate (CAS Reg. No.
113894–85–2); amylopectin, hydrogen
1-octadecenylbutanedioate (CAS Reg.
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No. 125109–81–1); and 2-hydroxypropyl
starch (CAS Reg. No. 9049–76–7), which
are three other modified starches
previously reviewed by the Agency.
EPA has determined that it is
appropriate to bridge amylopectin, acidhydrolyzed, 1-octenylbutanedioate;
amylopectin, hydrogen 1octadecenylbutanedioate; and 2hydroxypropyl starch data to assess
starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- due to
similarities in the manufacturing
processes, functional groups/structure,
composition, and physical/chemical
properties of these modified starches.
In acute studies, the oral lethal dose,
LD50 of the modified starches was >
7,000 milligrams/kilogram (mg/kg).
Various modified starches were tested
in repeat dose studies, and no toxicity
was observed at doses as high as 9,000
mg/kg/day. No fetal, parental, or
reproductive toxicity was seen in any of
the multi-generational reproduction
toxicity studies at dietary levels up to
62% (i.e., 31,000 mg/kg/day).
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-andassessing-pesticide-risks/overview-riskassessment-pesticide-program.
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The hazard profile of these modified
starches is adequately defined. Overall,
they show low acute, subchronic, and
developmental toxicity. No systemic
toxicity is observed up to the limit dose
of 1,000 mg/kg/day and as high as
31,000 mg/kg/day. Since signs of
toxicity were not observed, no
toxicological endpoints of concern or
PODs were identified. Therefore, a
qualitative risk assessment for starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- can be
performed.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid-, EPA
considered exposure under the
proposed exemptions from the
requirement of a tolerance and from
existing uses. EPA assessed dietary
exposures from starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- in food as
follows:
Modified food starches are approved
(21 CFR 172.892) by the U.S. Food and
Drug Administration (FDA) as food
additives and are used in a wide range
of food products. In addition, dietary
(food and drinking water) exposure is
possible from the use of modified
starches when used as food use inert
ingredients in pesticide 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, and hard
surface disinfection on walls, floors,
tables). Starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- are not
currently proposed for pesticide
residential uses; however, future uses
may include uses in and around the
home. Residential exposure is also
possible from the use of modified
starches in non-pesticidal products such
as cosmetics. However, a quantitative
residential exposure assessment was not
conducted since a toxicological
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endpoint for risk assessment was not
identified.
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 starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- to share a
common mechanism of toxicity with
any other substances, and these
modified starches do not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
these tolerance exemptions, therefore,
EPA has assumed that starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- do 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 safety
factor. 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 starch,
1-octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid-, EPA has
concluded that there are no
toxicological endpoints of concern for
the U.S. population, including infants
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and children. Because there are no
threshold effects associated with these
chemicals, EPA conducted a qualitative
assessment. As part of that assessment,
the Agency did not use safety factors for
assessing risk, and no additional safety
factor is needed for assessing risk to
infants and children.
E. Aggregate Risks and Determination of
Safety
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 starch, 1octenylbutanedioate, aluminum salt;
dextrin, hydrogen 1octenylbutanedioate; and amylopectin,
2-hydroxypropyl ether, acid- residues.
V. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing exemptions from
the requirement of a tolerance without
any numerical limitation.
VI. Conclusions
Therefore, exemptions from the
requirement of a tolerance are
established for residues of starch, 1octenylbutanedioate, aluminum salt
(CAS Reg. No. 9087–61–0); dextrin,
hydrogen 1-octenylbutanedioate (CAS
Reg. No. 68070–94–0); and amylopectin,
2-hydroxypropyl ether, acid- (CAS Reg.
No. 2756130–86–4) when used as inert
ingredients (for seed treatment only) in
pesticide formulations applied preharvest under 40 CFR 180.920.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
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26501
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 exemptions 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,
E:\FR\FM\01MYR1.SGM
01MYR1
26502
Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Rules and Regulations
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 25, 2023.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
No. 2756130–86–4)’’; ‘‘Dextrin,
hydrogen 1-octenylbutanedioate (CAS
Reg. No. 68070–94–0)’’; and ‘‘Starch, 1octenylbutanedioate, aluminum salt
(CAS Reg. No. 9087–61–0)’’ to read 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 § 180.920, amend table 1 to the
section by adding, in alphabetical order,
entries for ‘‘Amylopectin, 2hydroxypropyl ether, acid- (CAS Reg.
■
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
*
*
Amylopectin, 2-hydroxypropyl ether, acid- (CAS Reg. No. 2756130– For seed treatment use only .........
86–4).
*
*
Binder, carrier, film-former.
*
*
*
*
*
Dextrin, hydrogen 1-octenylbutanedioate (CAS Reg. No. 68070–94–0) For seed treatment use only .........
*
*
Binder, carrier, film-former.
*
*
*
*
*
Starch, 1-octenylbutanedioate, aluminum salt (CAS Reg. No. 9087– For seed treatment use only .........
61–0).
*
*
Flow aid, flow enhancer, anti-caking agent
*
*
*
*
*
[Docket No. 230425–0113]
access permit holders to continue to
operate sectors, as authorized under the
Northeast Multispecies Fishery
Management Plan, and to exempt
sectors from certain effort control
regulations to improve the efficiency
and economics of sector vessels.
Approval of sector operations plans and
contracts is necessary to allocate annual
catch entitlements to the sectors in
order for sectors to operate.
RTID 0648–XC579
DATES:
[FR Doc. 2023–09090 Filed 4–28–23; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
Magnuson-Stevens Act Provisions;
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; Approval of 2023 and 2024
Sector Operations Plans and
Allocation of 2023 Northeast
Multispecies Annual Catch
Entitlements
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule.
AGENCY:
This final rule approves
sector operations plans and contracts,
including 18 regulatory exemptions for
fishing years 2023 and 2024. This final
rule also allocates Northeast
multispecies annual catch entitlements
to approved groundfish sectors for
fishing year 2023; this includes default
specifications for nine stocks. This
action is intended to allow limited
SUMMARY:
lotter on DSK11XQN23PROD with RULES1
Uses
VerDate Sep<11>2014
15:55 Apr 28, 2023
Jkt 259001
Sector operations plans and
regulatory exemptions are effective May
1, 2023, through April 30, 2025.
Northeast multispecies annual catch
entitlements for sectors are effective
May 1, 2023, through April 30, 2024.
Default catch limits are effective May 1,
2023, through October 31, 2023, or until
the final rule for Framework 65 is
implemented, if that final rule is
implemented prior to October 31, 2023.
If Framework 65 is not implemented on
or before October 31, 2023, all fishing
for these stocks would be prohibited
beginning November 1, 2023.
Copies of each sector’s
operations plan and contract are
available from the NMFS Greater
Atlantic Regional Fisheries Office
(GARFO): Contact Samantha Tolken at
Samantha.Tolken@noaa.gov. These
documents are also accessible via the
GARFO website. To view these
documents and the Federal Register
documents referenced in this rule, you
can visit: https://www.fisheries.noaa
ADDRESSES:
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
*
*
.gov/management-plan/northeastmultispecies-management-plan.
FOR FURTHER INFORMATION CONTACT:
Samantha Tolken, Fishery Management
Specialist, (978) 675–2176.
SUPPLEMENTARY INFORMATION:
Background
The Northeast Multispecies Fishery
Management Plan (FMP) defines a
sector as a group of persons holding
limited access Northeast multispecies
permits that has voluntarily entered into
a contract and agree to certain fishing
restrictions for a specified period of
time, and that has been granted a
portion of the total allowable catch
(TAC) in order to achieve objectives
consistent with applicable FMP goals
and objectives. A sector must be
comprised of at least three Northeast
multispecies permits issued to at least
three different persons, none of whom
have any common ownership interest in
the permits, vessels, or businesses
associated with the permits issued to
the other two or more persons in that
sector. Sectors are self-selecting,
meaning each sector can choose its
members.
The Northeast multispecies sector
management system allocates a portion
of the Northeast multispecies stocks to
each sector. These annual sector
allocations are known as annual catch
entitlements (ACE) and are based on the
collective fishing history of a sector’s
members. Sectors may receive
E:\FR\FM\01MYR1.SGM
01MYR1
]]>Agencies
[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Rules and Regulations]
[Pages 26498-26502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09090]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0273, EPA-HQ-OPP-2022-0841 and EPA-HQ-OPP-2022-0844;
FRL-10877-01-OCSPP]
Starch, 1-Octenylbutanedioate, Aluminum Salt; Dextrin, Hydrogen
1-Octenylbutanedioate; and Amylopectin, 2-Hydroxypropyl Ether, Acid-;
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of starch, 1-octenylbutanedioate, aluminum
salt; dextrin, hydrogen 1-octenylbutanedioate; and amylopectin, 2-
hydroxypropyl ether, acid- when used as inert ingredients (for seed
treatment only) in pesticide formulations applied pre-harvest.
Ingredion Incorporated submitted petitions to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish maximum permissible levels for
residues of starch, 1-octenylbutanedioate, aluminum salt; dextrin,
hydrogen 1-octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether,
acid- when used in accordance with the terms of the exemptions.
DATES: This regulation is effective May 1, 2023. Objections and
requests for hearings must be received on or before June 30, 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 dockets for these actions, identified by docket
identification (ID) numbers EPA-HQ-OPP-2021-0273, EPA-HQ-OPP-2022-0841
and EPA-HQ-OPP-2022-0844, are 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 the 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: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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).
[[Page 26499]]
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 numbers EPA-HQ-OPP-2021-0273, EPA-HQ-OPP-2022-0841 and EPA-
HQ-OPP-2022-0844 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 June 30,
2023. Addresses for mail and hand delivery of objections and hearing
requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID numbers EPA-HQ-OPP-2021-0273, EPA-HQ-
OPP-2022-0841 and EPA-HQ-OPP-2022-0844, 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. Petitions for Exemption
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of pesticide petition PP IN-11458 by
Ingredion Incorporated, 5 Westbrook Corporate Center, Westchester, IL
60154. The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of starch, 1-octenylbutanedioate, aluminum salt (CAS Reg. No.
9087-61-0) when used as an inert ingredient in pesticide formulations
applied ``in or on raw agricultural commodities pre-harvest and as a
seed treatment.'' A summary of the petition prepared by Ingredion
Incorporated is available in the docket at https://www.regulations.gov.
Ingredion Incorporated subsequently clarified that the word ``and''
should not have been included in the request and that they were
requesting an exemption under 40 CFR 180.920 for seed treatment use
only. Therefore, a use pattern limitation for seed treatment use is
being established for this exemption.
In the Federal Register of November 17, 2022 (87 FR 68959) (FRL-
9410-07-OCSPP), EPA issued documents pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of pesticide petitions PP IN-11699
and PP IN-11715 by Ingredion Incorporated, 5 Westbrook Corporate
Center, Westchester, IL 60154. The petitions requested that 40 CFR
180.920 be amended by establishing exemptions from the requirement of a
tolerance for residues of dextrin, hydrogen 1-octenylbutanedioate (CAS
Reg. No. 68070-94-0) and amylopectin, 2-hydroxypropyl ether, acid- (CAS
Reg. No. 2756130-86-4) when used as inert ingredients (for seed
treatment only) in pesticide formulations applied pre-harvest.
Summaries of the petitions prepared by Ingredion Incorporated are
available in the dockets at https://www.regulations.gov.
There were no comments received in response to the notices 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 from the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to account for 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 an exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' 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,
[[Page 26500]]
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 these
actions. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1-octenylbutanedioate; and
amylopectin, 2-hydroxypropyl ether, acid-, including exposure resulting
from the exemptions established by this action. EPA's assessment of
exposures and risks associated with starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1-octenylbutanedioate; and
amylopectin, 2-hydroxypropyl ether, acid- 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 starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1-octenylbutanedioate; and
amylopectin, 2-hydroxypropyl ether, acid- as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
The toxicological database for starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1-octenylbutanedioate; and
amylopectin, 2-hydroxypropyl ether, acid-, all of which are modified
starches, is supported by data regarding amylopectin, acid-hydrolyzed,
1-octenylbutanedioate (CAS Reg. No. 113894-85-2); amylopectin, hydrogen
1-octadecenylbutanedioate (CAS Reg. No. 125109-81-1); and 2-
hydroxypropyl starch (CAS Reg. No. 9049-76-7), which are three other
modified starches previously reviewed by the Agency. EPA has determined
that it is appropriate to bridge amylopectin, acid-hydrolyzed, 1-
octenylbutanedioate; amylopectin, hydrogen 1-octadecenylbutanedioate;
and 2-hydroxypropyl starch data to assess starch, 1-
octenylbutanedioate, aluminum salt; dextrin, hydrogen 1-
octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether, acid- due
to similarities in the manufacturing processes, functional groups/
structure, composition, and physical/chemical properties of these
modified starches.
In acute studies, the oral lethal dose, LD50 of the
modified starches was > 7,000 milligrams/kilogram (mg/kg). Various
modified starches were tested in repeat dose studies, and no toxicity
was observed at doses as high as 9,000 mg/kg/day. No fetal, parental,
or reproductive toxicity was seen in any of the multi-generational
reproduction toxicity studies at dietary levels up to 62% (i.e., 31,000
mg/kg/day).
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.
The hazard profile of these modified starches is adequately
defined. Overall, they show low acute, subchronic, and developmental
toxicity. No systemic toxicity is observed up to the limit dose of
1,000 mg/kg/day and as high as 31,000 mg/kg/day. Since signs of
toxicity were not observed, no toxicological endpoints of concern or
PODs were identified. Therefore, a qualitative risk assessment for
starch, 1-octenylbutanedioate, aluminum salt; dextrin, hydrogen 1-
octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether, acid- can
be performed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to starch, 1-octenylbutanedioate, aluminum salt; dextrin,
hydrogen 1-octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether,
acid-, EPA considered exposure under the proposed exemptions from the
requirement of a tolerance and from existing uses. EPA assessed dietary
exposures from starch, 1-octenylbutanedioate, aluminum salt; dextrin,
hydrogen 1-octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether,
acid- in food as follows:
Modified food starches are approved (21 CFR 172.892) by the U.S.
Food and Drug Administration (FDA) as food additives and are used in a
wide range of food products. In addition, dietary (food and drinking
water) exposure is possible from the use of modified starches when used
as food use inert ingredients in pesticide 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, and hard surface disinfection on walls, floors, tables). Starch,
1-octenylbutanedioate, aluminum salt; dextrin, hydrogen 1-
octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether, acid- are
not currently proposed for pesticide residential uses; however, future
uses may include uses in and around the home. Residential exposure is
also possible from the use of modified starches in non-pesticidal
products such as cosmetics. However, a quantitative residential
exposure assessment was not conducted since a toxicological
[[Page 26501]]
endpoint for risk assessment was not identified.
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 starch, 1-
octenylbutanedioate, aluminum salt; dextrin, hydrogen 1-
octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether, acid- to
share a common mechanism of toxicity with any other substances, and
these modified starches do not appear to produce a toxic metabolite
produced by other substances. For the purposes of these tolerance
exemptions, therefore, EPA has assumed that starch, 1-
octenylbutanedioate, aluminum salt; dextrin, hydrogen 1-
octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether, acid- do
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
safety factor. 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 starch, 1-octenylbutanedioate,
aluminum salt; dextrin, hydrogen 1-octenylbutanedioate; and
amylopectin, 2-hydroxypropyl ether, acid-, 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 these chemicals, EPA conducted a qualitative
assessment. As part of that assessment, the Agency did not use safety
factors for assessing risk, and no additional safety factor is needed
for assessing risk to infants and children.
E. Aggregate Risks and Determination of Safety
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 starch, 1-octenylbutanedioate, aluminum salt; dextrin,
hydrogen 1-octenylbutanedioate; and amylopectin, 2-hydroxypropyl ether,
acid- residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing exemptions from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established for residues of starch, 1-octenylbutanedioate, aluminum
salt (CAS Reg. No. 9087-61-0); dextrin, hydrogen 1-octenylbutanedioate
(CAS Reg. No. 68070-94-0); and amylopectin, 2-hydroxypropyl ether,
acid- (CAS Reg. No. 2756130-86-4) when used as inert ingredients (for
seed treatment only) in pesticide formulations applied pre-harvest
under 40 CFR 180.920.
VII. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions 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,
[[Page 26502]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 25, 2023.
Charles Smith,
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. 180.920, amend table 1 to the section by adding, in
alphabetical order, entries for ``Amylopectin, 2-hydroxypropyl ether,
acid- (CAS Reg. No. 2756130-86-4)''; ``Dextrin, hydrogen 1-
octenylbutanedioate (CAS Reg. No. 68070-94-0)''; and ``Starch, 1-
octenylbutanedioate, aluminum salt (CAS Reg. No. 9087-61-0)'' to read
as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to 180.920
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Amylopectin, 2-hydroxypropyl For seed treatment Binder, carrier,
ether, acid- (CAS Reg. No. use only. film-former.
2756130-86-4).
* * * * * * *
Dextrin, hydrogen 1- For seed treatment Binder, carrier,
octenylbutanedioate (CAS Reg. use only. film-former.
No. 68070-94-0).
* * * * * * *
Starch, 1-octenylbutanedioate, For seed treatment Flow aid, flow
aluminum salt (CAS Reg. No. use only. enhancer, anti-
9087-61-0). caking agent
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-09090 Filed 4-28-23; 8:45 am]
BILLING CODE 6560-50-P
