[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Rules and Regulations]
[Pages 63291-63296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17003]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0232; FRL-12153-01-OCSPP]
Potassium Carbonate; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of potassium carbonate in or on all food
commodities when used as a biochemical fungicide in accordance with
label directions and good agricultural practices. Biofungitek, S.L.
submitted a petition, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance for the biochemical pesticide potassium
carbonate. This regulation eliminates the need to establish a maximum
permissible level for residues of potassium carbonate under FFDCA when
used in accordance with this exemption.
DATES: This regulation is effective August 5, 2024. Objections and
requests for hearings must be received on or before October 4, 2024 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-2021-0232, 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 for the OPP Docket is (202) 566-1744. Please review
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1599; 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, greenhouse owner, 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).
[[Page 63292]]
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-2021-0232, 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
October 4, 2024. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0232 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. Background and Statutory Findings
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F8851) by Biofungitek, S.L, Parque Cient[iacute]fico y
Tecnol[oacute]gico de Bizkaia, Astondo Bidea (Building 612), 48160
Derio, Spain (c/o Compliance Services International, 7501 Bridgeport
Way West, Lakewood, WA 94899). The petition requested that 40 CFR part
180 be amended to establish an exemption from the requirement of a
tolerance for residues of potassium carbonate, when used as a
biochemical fungicide in or on all agricultural food commodities in
accordance with label directions and good agricultural practices. That
document referenced a summary of the petition prepared by Biofungitek,
S.L., which is available in the docket at https://www.regulations.gov.
No comments were received on the notice of filing.
III. 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 exemption 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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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. . .
.'' Additionally, FFDCA section 408(b)(2)(D) requires that 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.''
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. If EPA is
able to determine that a tolerance is not necessary to ensure that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, 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 potassium carbonate, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with potassium carbonate
follows.
A. Toxicological Profile
Potassium carbonate is a white, odorless solid that is classified
as an inorganic salt. It is used as a leavening agent in pastas and
breads, a pH adjustor for chocolate production, a buffering agent for
making wine, and a dietary supplement in chicken feed. The Joint Food
and Agriculture Organization of the United Nations (FAO)/World Health
Organization (WHO) Expert Committee on Food Additives has determined
that potassium carbonate has no limited terms for daily intake when
used as a food additive (JFAO/WHO, 1966). Additionally, potassium
carbonate has been granted ``Generally Recognized as Safe'' (GRAS)
status for use as a food additive by the United States Food and Drug
Administration (FDA) per 21 CFR 184.1613.
With regard to historical risk, humans have been regularly exposed
to potassium carbonate in the environment without known incident. This
naturally occurring inorganic salt is ubiquitous in the environment.
Potassium carbonate is regularly found in soil, and is a primary
constituent of potash, which has been used as a primary ingredient in
ceramics, soaps and fertilizers since the Bronze Age. Currently, humans
are also regularly exposed to potassium carbonate in cosmetics and
foods without known toxic effects. Although humans are regularly
exposed to this compound in the home and in the
[[Page 63293]]
natural environment, sustained exposures of any significant
concentration are unlikely in the environment, as this inorganic salt
is extremely soluble, readily dissociating into nontoxic ions in the
environment. Given humans' regular exposures to potassium carbonate
without incident, its high solubility and its overall low toxicological
profile, no significant risks are expected relative to any potential
pesticidal exposures.
As an active ingredient in pesticidal end-use products (EPs),
potassium carbonate is a biochemical fungicide intended to be applied
by spray to crops, turf and ornamentals in both agricultural and
residential settings. Potential exposures to potassium carbonate are
not expected to result in any risks of toxicological concern. Potassium
carbonate is not expected to pose a risk through any pathways for the
following reasons. (1) Potassium carbonate is highly water soluble and
is expected to dissociate into nontoxic potassium and carbonate ions
soon after any pesticidal application. (2) The human body has natural
regulation mechanisms for dietarily processing the potassium and
carbonate ions that comprise the salt, potassium carbonate.
Specifically, the kidneys regulate the concentration of these ions; and
excess ions are filtered out and excreted through urine. (3) Potassium
and carbonate ions naturally occur and are already ubiquitous in the
environment; and no significant increase in exposure to potassium and
carbonate ions are expected relative to pesticidal use of potassium
carbonate. (4) With regard to any potential oral toxicity, potassium
carbonate showed low acute oral toxicity and no major adverse effects
in the available subchronic oral toxicity database. (5) Based on the
physicochemical properties, potassium carbonate degrades rapidly in the
environment and is not anticipated to be present in any concentration
outside potential naturally occurring background levels. (6) No
toxicological endpoints have been identified for potassium carbonate.
All the data submitted in support of the registration of this potassium
carbonate confirm its low risk relative to any pesticidal exposures.
With regard to the overall toxicological profile, potassium
carbonate is of low toxicity through most routes of exposure.
All acute toxicity data requirements for potassium carbonate were
satisfied by either guideline studies or waiver rationales. The
guideline studies submitted for potassium carbonate resulted in the
active ingredient being classified as Toxicity Category IV for acute
dermal and inhalation toxicity, and Toxicity Category III for acute
oral toxicity. The data requirements for primary eye and dermal
irritation were satisfied by rationales. The applicant observed that
because potassium chloride as an inorganic salt has high pH, it is both
is severely irritating and corrosive. In recognition of these physical-
chemical characteristics, the applicant ascribed Toxicity Category I
for both primary eye and primary dermal irritation. However, it must be
noted that when potassium carbonate is added to the aqueous end-use
product, which has been assessed as part of the assessment for
potassium carbonate, the irritating effects are greatly diminished, and
the primary eye and primary dermal irritation for that end-use product
are Toxicity Category III. Lastly, available data indicate that
potassium carbonate is not a skin sensitizer.
All subchronic data requirements for the active ingredient
potassium carbonate were satisfied with acceptable waiver rationales
and a non-guideline study. The 90-day dermal toxicity and 90-day
inhalation toxicity data requirements were satisfied by waiver
rationales based primarily on low exposure and low toxicity. The
subchronic oral toxicity data requirement was satisfied by a non-
guideline subchronic oral toxicity repeat-dose oral 90-day dietary
study using an acceptable surrogate salt, potassium bicarbonate.
In the 90-day oral toxicity on potassium bicarbonate, rats were
dosed at 1,480 and 3,130 mg/kg/day (males), and 1,660 and 3,530 mg/kg/
day (females) in the diet. The feeding study resulted in a no observed
adverse effect level (NOAEL) of 1,480 mg/kg/day in males and 1,660 mg/
kg/day in female rats. The dose levels tested were well above the limit
dose of 1,000 mg/kg/day. There were no treatment-related adverse
effects on mortality, clinical signs, functional observational battery
(FOB), body weight, body weight gain, food consumption, ophthalmoscopy,
macroscopic findings, testosterone, follicle stimulating hormone,
luteinizing hormone levels, organ weights, or histopathology.
A waiver rationale for the 90-day dermal toxicity requirement was
assessed by the Office of Pesticide Program's (OPP's) Hazard and
Science Policy Council (HASPOC) using a weight of the evidence (WOE)
approach that considered all of the available hazard and exposure
information. The rationale for 90-day dermal toxicity was determined to
be sufficient to satisfy the data requirement based on the following
considerations: (1) potassium carbonate has been assigned Toxicity
Category IV for acute dermal toxicity and is not a dermal sensitizer;
(2) there were no adverse effects observed in the available repeat oral
dose toxicity study with similar salts, including potassium
bicarbonate; (3) humans have a history of exposure to potassium
carbonate and similar carbonate salts without adverse reactions as seen
in cosmetics and foods approved for use by the FDA; (4) the physical
chemical properties of potassium carbonate such as high pH, high
solubility in water, a low partition coefficient and low vapor pressure
indicate a low probability for dermal penetration; (5) the carbonates
and bicarbonates are recognized as GRAS by the FDA (21 CFR 184.1619)
for use as flavoring agents; (6) potassium carbonate is approved for
inert ingredient (buffering agent) use in pesticide products and has an
exemption from the requirement of a tolerance (40 CFR 180.920) when
applied to growing crops; (7) human health risk from occupational
dermal exposure to the proposed pesticide product is expected to be
comparatively minimal, as the maximum concentration reported in
cosmetics is 93.4% (in rinse-off products), which already exceeds the
product formulation concentration (58.04%) of the proposed EP prior to
being further diluted into a spray solution; and (8) using a
conservative dermal absorption estimate of 10% and an oral point of
departure (POD) of 180 mg/kg/day, any potential exposure would be far
below the limit dose of 1,000 mg/kg/day.
A waiver rationale for the 90-day inhalation toxicity requirement
was assessed by the OPP's HASPOC using a WOE approach that considered
all of the available hazard and exposure information. The rationale for
90-day inhalation toxicity was determined to be sufficient to satisfy
the data requirement based on the following considerations: (1) the
physical-chemical properties of potassium carbonate show negligible
vapor pressure because it is a solid powder that dissociates into K\+\
and CO32- ions when mixed with water; (2) the
toxic effects of potassium carbonate are low based on the acute
inhalation toxicity study (Toxicity Category IV); (3) during a non-
guideline 21-day inhalation study for a potassium carbonate-based
scrubbing solution, male and female rats dosed at 0.1, 0.2, and 0.4 mg/
L showed no adverse systemic or neurotoxic effects; (4) no adverse
effects or evidence of irritation were identified in the publicly
available repeat-dose oral toxicity or
[[Page 63294]]
developmental toxicity studies; and (5) although a qualitative risk
assessment approach was taken, relevant margins of exposure (MOEs) were
calculated from an oral POD of 180 mg/kg/day to represent worst-case
scenarios. The occupational and residential handler MOEs ranged from
13,000 to 90,000,000 which are above 10X the Agency's Level of Concern
(LOC) of 100.
The data requirements for developmental toxicity were satisfied
with the submission of four acceptable non-guideline developmental
toxicity studies. No adverse effects on maternal or developmental
parameters up to the highest doses tested were reported in the test
ani. One developmental study administered potassium carbonate via oral
gavage at 290 mg/kg/day to mice and at 180 mg/kg/day to rats. No
discernible effects were observed on implantation, maternal or fetal
survival; and no abnormalities were observed in soft or skeletal
tissues. Another study using an accepted surrogate, potassium
bicarbonate, was conducted on pregnant animals up to 330 mg/kg/day in
rabbits, 340 mg/kg/day in rats, and 580 mg/kg/day in mice. No adverse
effects were observed for any animals. In a third study, sodium
carbonate, a carbonate which is significantly similar to potassium
carbonate, was administered via oral gavage at dose levels up to 179
mg/kg/day in mice, 245 mg/kg/day in rats, and 340 mg/kg/day in rabbits
with no adverse effects observed. In a fourth study, calcium carbonate,
another carbonate which is significantly similar to potassium
carbonate, was administered to rats up to 2,188 mg/kg/day in the diet
showed no evidence of maternal toxicity or embryotoxic/teratogenic
effects. In short, potassium carbonate is of low toxicity and
significant exposure from use as a pesticide is not anticipated and, as
such, is not expected to pose any risks with regard to developmental
toxicity.
Genotoxicity and mutagenicity data requirements were satisfied
through a variety of studies from the open scientific literature on
potassium carbonate and similar carbonate/bicarbonate salts indicated
that potassium carbonate and related carbonates are not genotoxic. (All
the similar carbonate and bicarbonate salts referenced were determined
to be acceptable surrogates as they were considered to be both
structurally and functionally similar.) In a non-guideline Ames test,
potassium carbonate tested negative and did not induce mutations in the
Salmonella typhimurium strains TA92, TA1535, TA1000, TA 1537, TA94, and
TA98 in the presence or absence of metabolic activation. In the same
non-guideline report, potassium carbonate did not induce chromosome
aberrations in a mammalian cell line (Chinese hamster fibroblasts) in
the presence and absence of S9 metabolic activation. In another study,
potassium bicarbonate and sodium bicarbonate, two carbonates considered
similar to potassium carbonate, both tested negative and did not induce
mutations in the S. typhimurium strains TA1535, TA1537, TA1538, TA98,
and TA100 in the presence or absence of metabolic activation. An in
vitro gene mutation guideline study in bacteria, showed calcium
carbonate, another carbonate considered to be similar to potassium
carbonate, was determined to be non-mutagenic to the S. typhimurium
strains TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2 uvrA
with and without metabolic activation. Calcium carbonate did not induce
chromosome aberrations in a mammalian cell line (L5178Y) in the
presence or absence of S9 metabolic activation. Lastly, a guideline
bacterial reverse mutation assay (OCSPP 870.5100) was submitted using
potassium carbonate (MRID 50898908). In the guideline Ames test,
potassium carbonate did not induce mutations in the S. typhimurium
strains TA98, TA100, TA1535, TA 1537, and Escherichia coli WP2 uvrA in
the presence or absence of metabolic activation. All submitted data
indicate that potassium carbonate is non-genotoxic and non-mutagenic.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoints have been identified for potassium
carbonate. The active ingredient is of low toxicity, and significant
exposure is not expected based on the low application rates and rapid
degradation in the environment.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. As
part of its qualitative risk assessment for potassium carbonate, the
Agency considered the potential for dietary exposure to residues of the
chemical. EPA concludes that dietary (food and drinking water)
exposures are expected to be negligible, as significant residues of the
substance are not anticipated on treated commodities at the time of
consumption based on its physical and chemical properties. Foremost,
potassium carbonate, an inorganic salt, is highly water soluble and is
expected to dissociate into potassium and carbonate ions soon after any
pesticidal application. Notably, potassium and carbonate ions naturally
occur and are already ubiquitous in the environment; and no significant
increase in exposure to potassium and carbonate ions are expected
relative to the proposed use of the EP. Equally important, the human
body has natural regulation mechanisms for potassium and carbonate ions
that enter the body. The kidneys regulate the concentration of these
ions; and excess ions are filtered out and excreted through urine.
Minimal exposure and compensatory regulation notwithstanding, no
dietary risks of concern are anticipated for any potential pesticidal
exposure, as no toxicological endpoint of concern was identified for
potassium carbonate through the oral route of exposure.
2. 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). Potassium
carbonate is intended for use in residential (non-occupational)
settings. However, significant residential exposure is not expected
because potassium carbonate is an inorganic ionic salt that does not
easily volatilize and readily dissociates into potassium and carbonate
ions in water. Both potassium and carbonate ions are ubiquitous in the
environment; and data indicate that no significant increase in exposure
to potassium carbonate is expected from use of potassium carbonate
pesticide products. In addition, the ions K\+\ and
CO32- resulting from the ionization
(dissociation) of K2CO3 will not influence the
natural K\+\ or CO32- level in the body due to
how the kidneys regulate the ion concentration found in the blood.
Given the physicochemical properties and rapid dissociation of the
ionic salt, residential handler and post-application exposures are not
expected.
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.'' EPA has not found that
potassium carbonate shares a common mechanism of toxicity with any
other substances, and it does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed potassium carbonate does not have a
common mechanism of toxicity with other substances. For information
regarding
[[Page 63295]]
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. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain 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. 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. An FQPA safety factor is not required at this time for
potassium carbonate because no toxicological endpoints have been
established and the qualitative risk assessment has concluded that
Potassium Carbonate is of low toxicity and that no significant
exposures are expected.
E. Aggregate Risk
In accordance with the FFDCA, OPP must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources that have the same toxicological endpoints are
added together and compared to quantitative estimates of hazard, or the
risks themselves can be aggregated. When aggregating exposures and
risks from various sources, EPA considers both the route and duration
of exposure. A qualitative aggregate risk assessment has been conducted
for the proposed use of potassium carbonate based on the lack of
identified endpoints in the toxicological database and minimal exposure
to the active ingredient. No risks of concern have been identified.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the May 31, 2023,
document entitled ``Product Chemistry Review and Human Health Risk
Assessment for FIFRA Section 3 Registration of the Manufacturing-Use
Product, Potassium Carbonate (99.5% Fine Powder) Containing Potassium
Carbonate (99.5%) as its Active Ingredient.'' This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
potassium carbonate.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusion
Therefore, EPA is establishing an exemption from the requirement of
a tolerance for residues of potassium carbonate in or on all food
commodities when used as a biochemical fungicide in accordance with
label directions and good agricultural practices.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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.
[[Page 63296]]
Dated: July 29, 2024.
Edward Messina,
Director, 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. Add Sec. 180.1413 to subpart D to read as follows:
Sec. 180.1413 Potassium Carbonate; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
residues of potassium carbonate in or on all food commodities when used
as a biochemical fungicide in or on all agricultural food commodities
in accordance with label directions and good agricultural practices.
[FR Doc. 2024-17003 Filed 8-2-24; 8:45 am]
BILLING CODE 6560-50-P