[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