Rule2025-13289
Acetamiprid; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 16, 2025
Effective
July 16, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of acetamiprid in or on multiple spice commodities that are identified and discussed in this document. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the American Spice Trade Association submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on these commodities.
Full Text
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<title>Federal Register, Volume 90 Issue 134 (Wednesday, July 16, 2025)</title>
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[Federal Register Volume 90, Number 134 (Wednesday, July 16, 2025)]
[Rules and Regulations]
[Pages 31894-31899]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13289]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0217; 12852-01-OCSPP]
Acetamiprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
acetamiprid in or on multiple spice commodities that are identified and
discussed in this document. Under the Federal Food, Drug, and Cosmetic
Act (FFDCA), the American Spice Trade Association submitted a petition
to EPA requesting that EPA establish a maximum permissible level for
residues of this pesticide in or on these commodities.
DATES: This rule is effective on July 16, 2025. Objections and requests
for hearings must be received on or before September 15, 2025 and must
be filed in accordance with the instructions provided in 40 CFR part
178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0217, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional instructions on commenting or
visiting the docket, along with more information about dockets
generally, 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; telephone number:
(202) 566-2427; email address: <a href="/cdn-cgi/l/email-protection#57051311051938233e3432241732273679303821"><span class="__cf_email__" data-cfemail="d2809694809cbda6bbb1b7a192b7a2b3fcb5bda4">[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 might apply to
them:
<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
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(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit
for a pesticide chemical residue in or on a food) only if EPA
determines that the tolerance is ``safe.'' FFDCA section
408(b)(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. FFDCA section 408(b)(2)(C)
requires 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. . .''
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-
2024-0217 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 September 15, 2025.
The EPA's Office of Administrative Law Judges (OALJ), in which 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 Filing and
Service,'' 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 the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the 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">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</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. Petitioned-For Tolerance
In the Federal Register of July 1, 2024 (89 FR 54398 (FRL-11682-05-
OCSPP)), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3F9085) by the American Spice Trade Association. The petition requested
that 40 CFR part 180 be amended by establishing tolerances
[[Page 31895]]
for residues of the insecticide acetamiprid in or on pepper, black at
0.1 parts per million (ppm) and the following spices at 2.0 ppm:
ambrette, seed; angelica, seed; angelica, dahurian, seed; anise, seed;
annatto, seed; candlebush; caraway, black, seed; caraway, seed; celery,
seed; chervil, seed; chinese nutmeg tree; coriander, seed; cubeb, seed;
culantro, seed; cumin, seed; dill, seed; fennel, seed; fennel flower,
seed; fenugreek, seed; grains of paradise, seed; guarana; honewort,
seed; lovage, seed; mahaleb; malabar tamarind; milk thistle; mustard,
black, seed; mustard, brown, seed; mustard, white, seed; nutmeg; poppy
seed; sesame seed; and wattle seed. That document referenced a summary
of the petition that was prepared by the petitioner and included in the
docket. No comments were received in response to that notice of filing.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. Based upon review
of the data supporting the petition and in accordance with its
authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing
tolerances that vary from what the petitioner sought. Specifically, EPA
is establishing tolerance values that are consistent with Organization
for Economic Cooperation and Development (OECD) rounding class
practice. EPA is also correcting commodity definitions for several
commodities. The reasons for these changes are explained in Unit IV.C.
EPA has determined that it has sufficient data to assess the
hazards of and to make a determination on aggregate exposure for
acetamiprid, including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with acetamiprid is summarized in this unit.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting discussions that previously published
in other tolerance rulemakings for the same pesticide chemical. Where
scientific information concerning a particular chemical remains
unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for this new rulemaking.
For acetamiprid, EPA previously published a tolerance rulemaking in
the Federal Register of February 14, 2020 (85 FR 8433 (FRL-10004-12)),
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to acetamiprid and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from that
rulemaking as described further in this rulemaking, as they remain
unchanged. Specific information on the risk assessment conducted in
support of this action, including on the studies received and the
nature of the adverse effects caused by acetamiprid, can be found in
the document titled ``Acetamiprid. Human Health Risk Assessment for
Proposed Tolerances for Residues, Without U.S. Registrations on Pepper,
Black and Spices in Crop Group 26 that Overlap with the Codex Crop
Subgroup of Spices, Seed'' (hereinafter ``Acetamiprid Human Health Risk
Assessment''), which is available in the docket for this action.
B. Toxicological Profile
For a discussion of the toxicological profile of acetamiprid, see
Unit III.A. in the final rule of February 14, 2020.
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOCs) 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
More detailed information on the toxicological endpoints for
acetamiprid used for human health risk assessment can be found in the
Acetamiprid Human Health Risk Assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetamiprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetamiprid tolerances in 40 CFR
180.578. EPA assessed dietary exposures from acetamiprid in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
in the toxicological studies for acetamiprid. In estimating acute
dietary exposure, EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID) Version
4.02. This software uses 2005-2010 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, the acute dietary exposure assessment used
tolerance-level residues, 100 percent crop treated (PCT), and empirical
and default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA likewise used DEEM-FCID, Version 4.02, which
incorporates 2005-2010 consumption data from USDA's NHANES/WWEIA. As to
residue levels in food, the chronic dietary exposure assessment used
tolerance-level residues except for milk and apple juice, for which EPA
used Pesticide Data Program monitoring data; 100 PCT; and empirical and
default processing factors. The chronic assessment also accounted for
potential residues from the food handling establishment (FHE) use of
acetamiprid. For commodities that would only have residues resulting
from the FHE use, EPA used a residue value of one-half of the existing
FHE tolerance and a PCT estimate of 4.65%.
iii. Cancer. EPA has concluded that acetamiprid is not likely to be
carcinogenic to humans. Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
[[Page 31896]]
iv. Anticipated residue and PCT information. FFDCA section
408(b)(2)(E) authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide residues that have been measured in food. If
EPA relies on such information, EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
FFDCA section 408(b)(2)(F) states that EPA may use data on the
actual percent of food treated for assessing chronic dietary risk only
if:
<bullet> Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
<bullet> Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
<bullet> Condition c: Data are available on pesticide use and food
consumption in a particular area and the exposure estimate does not
understate exposure for the population in such area.
In addition, EPA must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The acute and chronic assessments assumed 100 PCT for agricultural
uses and the PCT estimate of 4.65% for the FHE use.
EPA estimates the percent of commodities treated in FHEs for uses
of active ingredients based on the best available information. This
includes survey information on pesticide usage related to the number of
facilities being treated, product forms used (e.g., liquids and
aerosols), and treatment schedule by FHE segments (e.g., warehouse,
food processor, distributor, and restaurant). EPA also incorporated the
best available information related to the transfer of commodities
between various segments of FHEs and the percent of food consumed by
location, either in the home or outside the home.
All information currently available has been considered and EPA has
concluded that for any active ingredient, including acetamiprid, there
is at most a 4.65% likelihood that a food commodity could contain
potential residues resulting from one or more treatments while in the
FHE channel of trade. Similar to estimates of agricultural use, this
estimate should be reconsidered in 5 years.
EPA believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. EPA is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows EPA to be reasonably certain
that no regional population is exposed to residue levels higher than
those estimated by the Agency. Other than the data available through
national food consumption surveys, EPA does not have available reliable
information on the regional consumption of food to which acetamiprid
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for acetamiprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of acetamiprid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment</a>.
Based on the Pesticide in Water Calculator and Provisional
Cranberry Model, the estimated drinking water concentrations of
acetamiprid for acute exposures are 88.1 parts per billion (ppb) in
surface water and 211 ppb in ground water, and for chronic exposures
are 12.7 ppb in surface water and 175 ppb in ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 211 ppb was used to assess
the contribution from drinking water. For the chronic dietary risk
assessment, the water concentration of value 175 ppb was used to assess
the contribution from drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). There are no new
proposed residential uses for acetamiprid at this time. However,
acetamiprid is currently registered for uses that could result in
residential handler and post-application exposures, including gardens
and trees, spot-on pet treatment, fly control, indoor crack/crevice,
mattresses for bed bug control, and animal barns. For a summary of
these exposures, see Unit III.C.3. in the final rule of February 14,
2020.
4. 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
considers ``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 acetamiprid to share a common mechanism of
toxicity with any other substances, and acetamiprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetamiprid 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. Safety Factor for Infants and Children
1. In general. 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
[[Page 31897]]
EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. Evidence of qualitative
susceptibility was observed in the 2-generation reproductive toxicity
study, with the offspring effects (reductions in pup weights, reduction
in litter size and viability, delays in weaning indices and the age to
attain vaginal opening and preputial separation) considered more severe
than the observed decrease in parental body weights. Qualitative
susceptibility was also seen in the developmental neurotoxicity study
with offspring effects (decreased pup weight, pre-weaning survival, and
decreased startle response) occurring in the presence of marginal
parental body weight decreases.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all scenarios, with the exception of the
assessment of inhalation exposure. The default FQPA 10X SF remains in
place for assessing inhalation exposure due to the lack of a subchronic
inhalation study. That decision is based on the following findings:
i. The toxicity database for acetamiprid is complete with the
exception of a subchronic inhalation study.
ii. Acetamiprid produced signs of neurotoxicity in the high dose
groups of the acute and developmental neurotoxicity studies in rats and
the subchronic toxicity study in mice. However, no neurotoxic findings
were reported in the subchronic neurotoxicity study in rats.
Additionally, there are clear NOAELs identified for the neurotoxicity
effects observed in the guideline studies. The doses and endpoints
selected for risk assessment are protective and account for all adverse
toxicological effects observed in the database.
iii. No quantitative or qualitative evidence of increased
susceptibility of fetuses to in utero exposure to acetamiprid was
observed in the developmental toxicity study in either rats or rabbits.
Although increased qualitative susceptibility was seen in the
reproduction toxicity and the DNT study, the degree of concern for the
effects is low. There are clear NOAELs for the offspring effect and
regulatory doses were selected to be protective of these effects. No
other residual uncertainties were identified with respect to
susceptibility. The endpoints and doses selected for acetamiprid are
protective of adverse effects in both offspring and adults.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues, and the chronic dietary
exposure assessment was slightly refined using 100 PCT and tolerance-
level residues for most agricultural commodities, with a PCT estimate
of 4.65% used for commodities that would only have residues resulting
from the FHE use. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
acetamiprid in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by acetamiprid.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute Population Adjusted Dose (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate margin of exposure (MOE)
exists. Where different routes of exposure have different levels of
concern, the Agency uses the aggregate risk index (ARI) approach for
calculating short-, intermediate-, and long-term aggregate risk
estimates.
1. Acute dietary risk. The acute dietary risk estimates for
acetamiprid are not of concern. Using the exposure assumptions
discussed in this unit for acute exposure, EPA has concluded that acute
exposure to acetamiprid from food and water is 75% of the aPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
2. Chronic dietary risk. The chronic dietary risk estimates for
acetamiprid are not of concern. Using the exposure assumptions
described in this unit for chronic exposure, EPA has concluded that
chronic exposure to acetamiprid from food and water is 31% of the cPAD
for all infants <1 year old, the population group receiving the
greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Acetamiprid is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to acetamiprid.
Using the exposure assumptions described in this unit for short-
term exposures, EPA used the ARI approach for calculating the exposure
estimates. Estimates greater than or equal to 1.0 are not of concern.
For all lifestages, the ARIs are greater than the target ARI of 1.0,
and are not of concern. The ARIs ranged from 1.4 to 5.3. Children 1 to
< 2 years old exposed to bed bug treatments indoors resulted in the
lowest aggregate ARI of 1.4.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified, and
intermediate-term exposure is expected; however, since the same
endpoint and POD were selected for short- and intermediate term
durations, short-term exposure and risk estimates are considered
protective of potential intermediate-term exposure and risk.
5. Long-term risk. For both adults and children, worst-case long-
term scenarios reflect post-application exposure to pets treated with
spot-on products. The long-term aggregate risk estimates are not of
concern.
6. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, acetamiprid is not likely to be carcinogenic to humans.
7. Determination of safety. Based on these risk assessments, 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 acetamiprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Approved tolerance enforcement methods for acetamiprid residues in
crops are available, including methods using gas chromatography with
electron capture detection (GC/ECD) analysis for vegetables and non-
citrus fruits, high-performance liquid chromatography with ultraviolet
detection (HPLC/UV) analysis for citrus fruits only, and HPLC with
tandem mass spectrometric
[[Page 31898]]
detection (LC/MS/MS) analysis for vegetables and non-citrus fruits. An
approved HPLC/UV tolerance enforcement method for livestock matrices is
available.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#91e3f4e2f8f5e4f4fcf4e5f9fef5e2d1f4e1f0bff6fee7"><span class="__cf_email__" data-cfemail="87f5e2f4eee3f2e2eae2f3efe8e3f4c7e2f7e6a9e0e8f1">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The tolerance levels established in this action are harmonized with
the established Codex MRLs for all commodities.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested.
Specifically, EPA is correcting commodity definitions for the following
commodities: ``caraway, black, seed'' and ``caraway, seed'' to
``caraway, black''; ``cumin, seed'' to ``cumin''; ``fennel, seed'' to
``fennel, common, seed''; ``grains of paradise, seed'' to ``grains of
paradise''; ``malabar tamarind'' to ``tamarind, seed''; ``mustard,
black, seed'', ``mustard, brown, seed'', and ``mustard, white, seed''
to ``mustard, seed''; and ``wattle seed'' to ``wattleseed''.
EPA is also establishing tolerance values that are consistent with
OECD rounding class practice by dropping trailing zeroes. EPA is
establishing tolerances at 2 ppm, rather than the requested 2.0 ppm,
for the following spices: ambrette, seed; angelica, seed; angelica,
dahurian, seed; anise, seed; annatto, seed; candlebush; caraway, black;
celery, seed; chervil, seed; chinese nutmeg tree; coriander, seed;
cubeb, seed; culantro, seed; cumin; dill, seed; fennel, common, seed;
fennel flower, seed; fenugreek, seed; grains of paradise; guarana;
honewort, seed; lovage, seed; mahaleb; tamarind, seed; milk thistle;
mustard, seed; and wattleseed.
V. Conclusion
Therefore, tolerances are established for residues of acetamiprid,
in or on pepper, black at 0.1 ppm and the following spices at 2 ppm:
ambrette, seed; angelica, seed; angelica, dahurian, seed; anise, seed;
annatto, seed; candlebush; caraway, black; celery, seed; chervil, seed;
chinese nutmeg tree; coriander, seed; cubeb, seed; culantro, seed;
cumin; dill, seed; fennel, common, seed; fennel flower, seed;
fenugreek, seed; grains of paradise; guarana; honewort, seed; lovage,
seed; mahaleb; milk thistle; mustard, seed; nutmeg; poppy seed; sesame,
seed; tamarind, seed and wattleseed.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 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.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
Since tolerance actions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this
action.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
state, local or tribal governments or on the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the federal government and the Indian tribes, or
on the distribution of power and responsibilities between the federal
government and Indian tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because tolerance actions like this one are exempt from
review under Executive Order 12866. However, EPA's 2021 Policy on
Children's Health applies to this action. This rule finalizes tolerance
actions under the FFDCA, which requires 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 . .
. '' (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in
Unit III.D.
[[Page 31899]]
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 2, 2025.
Charles Smith,
Director, Registration Division Office of Pesticide Programs.
For the reasons set forth 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. Amend Sec. 180.578, by:
0
a. Adding the heading ``Table 1 to Paragraph (a)(1)'' to the table in
paragraph (a)(1);
0
b. Adding the following commodities in alphabetical order to the table
in paragraph (a)(1): ``ambrette, seed''; ``angelica, seed'';
``angelica, dahurian, seed''; ``anise, seed''; ``annatto, seed'';
``candlebush''; ``caraway, black''; ``celery, seed''; ``chervil,
seed''; ``chinese nutmeg tree''; ``coriander, seed''; ``cubeb, seed'';
``culantro, seed''; ``cumin''; ``dill, seed''; ``fennel, common,
seed''; ``fennel flower, seed''; ``fenugreek, seed''; ``grains of
paradise''; ``guarana''; ``honewort, seed''; ``lovage, seed'';
``mahaleb''; ``milk thistle''; ``mustard, seed''; ``nutmeg''; ``pepper,
black''; ``poppy seed''; ``sesame, seed''; ``tamarind, seed'';
``wattleseed''; and
0
c. Adding an end note 2 to the table in paragraph (a)(1).
The additions read as follows:
Sec. 180.578 Acetamiprid; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Ambrette, seed \2\.......................................... 2
Angelica, seed \2\.......................................... 2
Angelica, dahurian, seed \2\................................ 2
Anise, seed \2\............................................. 2
Annatto, seed \2\........................................... 2
* * * * *
Candlebush \2\.............................................. 2
* * * * *
Caraway, black \2\.......................................... 2
Celery, seed \2\............................................ 2
* * * * *
Chervil, seed \2\........................................... 2
Chinese nutmeg tree \2\..................................... 2
* * * * *
Coriander, seed \2\......................................... 2
* * * * *
Cubeb, seed \2\............................................. 2
Culantro, seed \2\.......................................... 2
Cumin \2\................................................... 2
Dill, seed \2\.............................................. 2
* * * * *
Fennel flower, seed \2\..................................... 2
Fennel, common, seed \2\.................................... 2
Fenugreek, seed \2\......................................... 2
* * * * *
Grains of paradise \2\...................................... 2
* * * * *
Honeywort, seed \2\......................................... 2
* * * * *
Lovage, seed \2\............................................ 2
Mahaleb \2\................................................. 2
Milk, thistle \2\........................................... 2
Mustard, seed \2\........................................... 2
Nutmeg \2\.................................................. 2
* * * * *
Pepper, black \2\........................................... 0.1
Poppy, seed \2\............................................. 2
* * * * *
Sesame, seed \2\............................................ 2
* * * * *
Tamarind, seed \2\.......................................... 2
* * * * *
Wattleseed \2\.............................................. 2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of February 10, 2010, for the use
of acetamiprid on dried tea.
\2\ There are no U.S. registrations for these commodities as of July 16,
2025.
* * * * *
[FR Doc. 2025-13289 Filed 7-15-25; 8:45 am]
BILLING CODE 6560-50-P
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