Rule2025-04707
Potassium Polyaspartate in Pesticide Formulations; Exemption From the Requirement of a Tolerance
Primary source
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Published
March 20, 2025
Effective
March 20, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of potassium polyaspartate (CASRN 64723-18- 8) when used as an inert ingredient (complexing agent), at a maximum of 10% in formulation, pre-harvest. Rosen's Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of potassium polyaspartate, when used in accordance with the terms of the exemptions.
Full Text
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<title>Federal Register, Volume 90 Issue 53 (Thursday, March 20, 2025)</title>
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[Federal Register Volume 90, Number 53 (Thursday, March 20, 2025)]
[Rules and Regulations]
[Pages 13089-13092]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04707]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0848; FRL-12666-01-OCSPP]
Potassium Polyaspartate in Pesticide Formulations; 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 polyaspartate (CASRN 64723-18-
8) when used as an inert ingredient (complexing agent), at a maximum of
10% in formulation, pre-harvest. Rosen's Inc., submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of potassium polyaspartate, when used in accordance with the
terms of the exemptions.
DATES: This regulation is effective March 20, 2025. Objections and
requests for hearings must be received on or before May 19, 2025 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-20220848, is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets generally,
along with instructions for visiting the docket in-person, is available
at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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: <a href="/cdn-cgi/l/email-protection#6f3d2b293d21001b060c0a1c2f0a1f0e41080019"><span class="__cf_email__" data-cfemail="adffe9ebffe3c2d9c4cec8deedc8ddcc83cac2db">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section
408(c)(2)(A)(i) 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.'' FFDCA section 408(c)(2)(A)(ii) 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
[[Page 13090]]
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, among other things, ``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. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2022-0848, 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 May 19, 2025.
EPA's Office of Administrative Law Judges (OALJ), where the Hearing
Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow
the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute. If you wish to
include CBI in your request, please follow the applicable instructions
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly
mark the information that you claim to be CBI. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice.
II. Petition for Exemption
In the Federal Register of November 17, 2022 (87 FR 68959, FRL
9410-07-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11696) by Rosen's Inc., 700 SW 291 Hwy. Suite 204, Liberty, MO 64068.
The petition requested that 40 CFR 180.920 be amended by establishing
an exemption from the requirement of a tolerance for residues of
potassium polyaspartate (CASRN 64723-18-8) when used as an inert
ingredient (complexing agent) at a maximum of 10% in pesticide
formulations applied pre-harvest under 40 CFR 180.920. That document
referenced a summary of the petition prepared by Rosen's Inc., the
petitioner, which is available in the docket. There were no comments
received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients in the pesticide, 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
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 for potassium polyaspartate
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
potassium polyaspartate 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 potassium polyaspartate 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 of potassium polyaspartate is also
supported by data regarding the analog sodium polyaspartate. EPA has
determined that since sodium polyaspartate is likely to mimic the
[[Page 13091]]
effects of sodium polyaspartate due to similarities in the functional
groups/structure, composition, metabolism, and physical/chemical
properties, it is appropriate to bridge sodium polyaspartate data to
assess potassium polyaspartate.
Potassium polyaspartate is anticipated to exhibit low levels of
acute toxicity via the oral, dermal, and inhalation routes of exposure.
It is not likely to be a skin or eye irritant or a skin sensitizer. No
adverse effects were reported in the 14-day and 90-day study in rats at
the limit dose of 1,000 mg/kg/day. Although developmental/reproductive
toxicity studies were not available, the 90-day study did not show any
adverse effects on reproductive parameters and there were no structural
alerts for developmental/reproductive toxicity when evaluated using
modeling. The 90-day study also performed a neurotoxicity screening,
and no signs of neurotoxicity were reported. No evidence of
immunotoxicity was seen in the studies. Furthermore, concern for
carcinogenicity is low, based on negative results in mutagenicity
studies, and the lack of structural alerts for carcinogenicity.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
The hazard profile of potassium polyaspartate is adequately
defined. Overall, potassium polyaspartate is of low acute, subchronic,
and developmental toxicity. No systemic toxicity is observed up to
1,000 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 potassium polyaspartate can be
performed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to potassium polyaspartate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from potassium polyaspartate in food as follows:
Dietary exposure (food and drinking water) to potassium
polyaspartate may occur following ingestion of foods with residues from
their use in accordance with this exemption. 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).
Potassium polyaspartate may be present in pesticide and non-pesticide
products that may be used in and around the home. However, a
quantitative residential exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
3. Cumulative effects from substances with a common mechanism of
toxicity. FFDCA section 408(b)(2)(D)(v) 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 potassium polyaspartate to share a common
mechanism of toxicity with any other substances, and potassium
polyaspartate does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance exemption,
therefore, EPA has assumed that potassium polyaspartate does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Additional Safety Factor for the Protection of Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
Based on an assessment of potassium polyaspartate 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 and low toxicity in available studies associated with
potassium polyaspartate, EPA conducted a qualitative assessment. As
part of that qualitative 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 potassium polyaspartate residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
potassium polyaspartate in or on any food commodities. EPA is
establishing a limitation on the amount of potassium polyaspartate that
may be used in pesticide formulations applied pre-harvest. This
limitation will be enforced through the pesticide registration process
under the Federal Insecticide,
[[Page 13092]]
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will
not register any pesticide formulation for food use that exceeds 10%
potassium polyaspartate in the final pesticide formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of potassium polyaspartate (CASRN 64723-18-8)
when used as an inert ingredient (complexing agent) at a maximum of 10%
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.).
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 (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), EPA will
submit a rule report to each the House of Congress, and to the
Comptroller General of the United States. This action does meet the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 10, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
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 180.920 by adding, in
alphabetical order, an entry for ``Potassium polyaspartate'' to read as
follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to Sec. 180.920
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Inert ingredients Limits Uses
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* * * * * * *
Potassium polyaspartate (CASRN 64723-18- Maximum of 10% in pesticide Complexing agent.
8). formulations.
* * * * * * *
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[FR Doc. 2025-04707 Filed 3-19-25; 8:45 am]
BILLING CODE 6560-50-P
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