Rule2025-03001
Cyprodinil; 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
February 26, 2025
Effective
February 26, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of cyprodinil in or on cranberry. The Interregional Project Number 4 (IR- 4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 90 Issue 37 (Wednesday, February 26, 2025)</title>
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[Federal Register Volume 90, Number 37 (Wednesday, February 26, 2025)]
[Rules and Regulations]
[Pages 10697-10702]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-03001]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0645; FRL-11459-01-OCSPP]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
cyprodinil in or on cranberry. The Interregional Project Number 4 (IR-
4) requested this tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 26, 2025. Objections and
requests for hearings must be received on or before April 28, 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-2022-0645, is available online 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, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#b3e1f7f5e1fddcc7dad0d6c0f3d6c3d29dd4dcc5"><span class="__cf_email__" data-cfemail="ebb9afadb9a5849f82888e98ab8e9b8ac58c849d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<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. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How do I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation
[[Page 10698]]
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-2022-0645 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 April
28, 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>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 23, 2022 (87 FR 58047) (FRL-
9410-05-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petition (2E9006) by the Interregional Research Project No. 4 (IR-4),
North Carolina State University, 1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition requests to amend 40 CFR 180.532
by establishing a tolerance for residues of the fungicide cyprodinil,
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on the
following raw agricultural commodity: cranberry at 0.4 parts per
million (ppm). That document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in the docket,
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in
response to the Notice of Filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA 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.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing 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. .
.''
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. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for cyprodinil including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with cyprodinil follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
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.
The major target organs of cyprodinil are the liver in both rats
and mice and the kidney in rats. Liver effects observed in subchronic
and chronic studies in rats and mice include increased liver weights,
increases in serum clinical chemistry parameters associated with
adverse effects on liver function, hepatocyte hypertrophy,
hepatocellular necrosis, and spongiosis hepatis. Adverse kidney effects
include tubular lesions and inflammation following subchronic exposure
of male rats. The hematopoietic system was also a target of cyprodinil,
which caused mild anemia in rats following subchronic exposure. There
was no evidence of increased in utero or postnatal susceptibility in
the developmental rat or rabbit study or in the 2-generation
reproduction study in the rat. An acute neurotoxicity study (ACN)
indicated systemic toxicity with signs of hunched posture,
piloerection, reduced responsiveness to sensory stimuli and reduced
motor activity, and hypothermia, but no neurotoxicity was observed in
the subchronic neurotoxicity study (SCN). A 28-day dietary
immunotoxicity study in mice resulted in no effects. No dermal or
systemic toxicity was seen following repeated dermal application up to
the limit dose in a 21-day dermal toxicity study in rats. There was no
evidence of carcinogenic potential in either the rat chronic toxicity/
carcinogenicity or mouse carcinogenicity studies. There was no evidence
of a mutagenic or cytogenetic effect in vivo or in vitro in studies
with cyprodinil.
Based on the lack of evidence of carcinogenicity in mice and rats
at doses that were judged to be adequate to the carcinogenic potential,
cyprodinil is classified as ``not likely to be carcinogenic to
humans.''
Specific information on the studies received and the nature of the
adverse effects caused by cyprodinil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document
titled ``Cyprodinil. Human Health Risk Assessment to Support the
Registration of the Proposed New Use on Cranberry.'' (hereinafter
``Cyprodinil Human Health Risk Assessment'') on pages 33-37 in docket
ID number EPA-HQ-OPP-2022-0645.
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
[[Page 10699]]
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/science-and-assessing-pesticide-risks/sing-human-health-risk-pesticides">https://www.epa.gov/science-and-assessing-pesticide-risks/sing-human-health-risk-pesticides</a>.
A summary of the toxicological endpoints and PODs for cyprodinil
used for human risk assessment can be found in the Cyprodinil Human
Health Risk Assessment on page 19.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerance as well as all existing cyprodinil tolerances in 40 CFR
180.572. EPA assessed dietary exposures from cyprodinil 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
for cyprodinil.
In estimating acute dietary exposure, EPA used the Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption
data from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). The acute dietary exposure assessment is
unrefined, assuming tolerance-level residues, default processing
factors, and 100 percent crop treated (PCT) for all crop and livestock
commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA also used the food consumption data from the USDA's
2005-2010 NHANES/WWEIA and DEEM-FDIC version 4.02. As to residue levels
in food, the chronic dietary exposure assessment is partially refined,
assuming tolerance-level residues for some commodities, average field
trial residues for the remaining commodities, default and empirical
processing factors, and average PCT estimates for some crops.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyprodinil is not likely to be carcinogenic to humans,
so it does not pose a cancer risk to humans. Therefore, a dietary
exposure assessment for the purpose of assessing cancer risk is
unnecessary.
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 the Agency 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, the Agency 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 Agency estimated the average PCT for existing uses as follows:
almond 25%; apple 30%; apricot 20%; artichoke 5%; beans, snap 2.5%;
blackberry 40%; blueberry 35%; broccoli 1%; brussels sprout 2.5%;
cabbage 10%; cantaloupe 1%; carrot 1%; cauliflower 1%; celery 1%;
cherries 2.5%; cucumber 1%; garlic 10%; grapes, wine 25%; grapes,
raisin 15%; grapes, table 55%; kiwi 20%; lemon 1%; lettuce 15%; lima
bean 1%; nectarine 15%; onion 10%; peach 30%; pear 15%; peppers 2.5%;
pistachio 2.5%; plum/prune 30%; pumpkin 5%; raspberry 65%; squash 5%;
strawberry 60%; tomato 2.5%; and watermelon 15%. EPA assumed 100 PCT
for all remaining commodities included in the chronic assessment.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use 1%
or 2.5% as the average PCT value, respectively. The maximum PCT figure
is the highest observed maximum value reported within the most recent
10 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%, except where
the maximum PCT is less than 2.5%, in which case, the Agency uses 2.5%
as the maximum PCT.
The Agency 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. The Agency 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 the Agency
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 cyprodinil may be applied in a particular area.
[[Page 10700]]
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyprodinil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyprodinil. 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 Flooded Application Model (PFAM) along with
the Pesticide in Water Calculator (PWC); groundwater and surface water
model, the estimated drinking water concentration (EDWC) of cyprodinil
for acute exposures is estimated to be 185 parts per billion (ppb) for
surface water. The EDWC of cyprodinil for chronic exposures is
estimated to be 119 ppb. These modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
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 (non-occupational) uses for
cyprodinil. Cyprodinil is currently registered for use on ornamental
landscapes on golf courses and around residential, institutional,
public, commercial, and industrial buildings, parks, recreational
areas, and athletic fields, that could result in residential exposure.
Currently, those labels require handlers to wear specific clothing
(e.g., long sleeve shirt/long pants) and/or use personal protective
equipment. Therefore, the Agency has made the assumption that these
products are not for homeowner use and has not conducted a quantitative
residential handler assessment. There are existing residential uses of
cyprodinil on ornamentals and therefore the potential for short-term
post-application dermal exposure to adults and children. However, a
quantitative residential post-application assessment was not conducted
because EPA did not identify a dermal hazard up to the limit dose of
1,000 mg/kg/day to select a dermal endpoint. Therefore, no residential
exposures are applicable for the aggregate assessment.
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
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis (https://www.epa.gov/pesticide-science-and-
assessing-pesticide-risks/pesticide-cumulative-risk-assessment-
framework). This document provides guidance on how to screen groups of
pesticides for cumulative evaluation using a two-step approach
beginning with the evaluation of available toxicological information
and, if necessary, followed by a risk-based screening approach. This
framework supplements the existing guidance documents for establishing
common mechanism groups (CMGs) and conducting cumulative risk
assessments (CRA). The Agency has utilized this framework for
cyprodinil and determined that cyprodinil along with pyrimethanil form
a candidate CMG. This group of pesticides is considered a candidate CMG
because they share characteristics to support a testable hypothesis for
a common mechanism of action.
Following this determination, the Agency conducted a screening-
level cumulative assessment for the candidate CMG of
anilinopyrimidines. This assessment indicated that cumulative aggregate
risk estimates are below the Agency's level of concern. The screening-
level assessment for the anilinopyrimidines has been updated to
incorporate the proposed new use of cyprodinil on cranberry. The
current screening-level assessment indicates that cumulative risk
estimates from cyprodinil and pyrimethanil are below the Agency's
levels of concern and therefore, no further cumulative evaluation is
necessary for cyprodinil at this time. For more information about the
anilinopyrimidines cumulative screening assessment, see Appendix E of
the Cyprodinil Human Health Risk Assessment in docket ID number EPA-HQ-
OPP-2022-0645.
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/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</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 EPA support the choice of a
different factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased pre- or post-utero susceptibility in the developmental rat or
rabbit studies or in the two-generation reproduction study. In the rat
developmental toxicity study, there were significantly lower mean fetal
weights in the high-dose group compared to controls, as well as a
significant increase in skeletal anomalies in the high-dose group due
to abnormal ossification. The skeletal anomalies/variations were
considered to be a transient developmental delay that occurs secondary
to the maternal toxicity (reduced body weight/body weight gain and
reduced food consumption) noted in the high-dose group. In the rabbit
study, the only treatment-related developmental effect was indication
of an increased incidence of a 13th rib at maternally toxic doses.
Signs of offspring effects in the rat 2-generation reproduction study
included significantly lower F<INF>1</INF> and F<INF>2</INF> pup
weights in the high-dose group during lactation, which continued to be
lower than controls post-weaning and after the pre-mating period
(examination in F<INF>1</INF> generation only). The offspring effects
occurred at the same high-dose levels at which maternal toxicity
(decreased body weight) was observed and were considered to be
secondary to maternal toxicity.
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 from 10X to 1X. That decision is based on the
following findings:
i. The toxicity database for cyprodinil is sufficient for a full
hazard evaluation and is considered adequate to evaluate risks to
infants and children. Acceptable studies have been submitted for
developmental toxicity, reproductive toxicity, acute and subchronic
neurotoxicity, and immunotoxicity. In addition, EPA recommends a
[[Page 10701]]
subchronic inhalation toxicity study be waived.
ii. In a subchronic neurotoxicity study in rats, there were no
treatment related effects on mortality, clinical signs, or gross or
histological neuropathology. Functional Observational Battery and motor
activity testing revealed no treatment related effects up to the
highest dose tested. In an acute neurotoxicity study in mice, clinical
signs, hypothermia, and changes in motor activity were all found to be
reversible and were no longer seen at day 8 and day 15 investigations.
There were no treatment related effects on mortality, gross, or
histological neuropathology.
iii. The available developmental guideline studies indicated no
increased susceptibility of rats or rabbits to in utero and/or from
postnatal exposure to cyprodinil. In the prenatal developmental
toxicity studies in rats and rabbits and the two-generation
reproduction study in rats, toxicity to the fetuses/offspring, when
observed, occurred at the same doses at which effects were observed in
maternal/parental animals.
iv. There are no residual uncertainties in the exposure database.
The dietary risk assessment is conservative and will not underestimate
dietary exposure to cyprodinil. The acute and chronic dietary
assessments utilized tolerance-level residues, average residue values
from field trial data (chronic only), empirical or HED's default
processing factors, and 100 PCT (acute only) or average PCT estimates
(chronic only). The dietary analyses also used modelled drinking water
estimates. For these reasons, it can be concluded that the dietary
analyses do not underestimate risk from acute or chronic exposure to
cyprodinil. There are no proposed residential uses and, for reasons
aforementioned, no quantitative residential assessment was conducted.
E. Aggregate Risk and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
population adjusted dose (aPAD) and the chronic population adjusted
dose (cPAD). Short-, intermediate-, and chronic term aggregate risks
are evaluated by comparing the estimated total food, water, and
residential exposure to the appropriate points of departure to ensure
that an adequate margin of exposure (MOE) exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyprodinil will occupy 7.6% of the aPAD for children 1 to 2 years
old, the most highly exposed population subgroup. Acute residential
exposure to cyprodinil is not expected. Therefore, the acute dietary
risk estimates serve as the acute aggregate risk assessment, which are
below the Agency's level of concern of 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyprodinil from food and water will utilize 47% of the cPAD for all
infants less than one year old, the most highly exposed population
subgroup. Chronic residential exposure to cyprodinil is not expected.
Therefore, the chronic dietary risk estimates serve as the chronic
aggregate risk assessment, which is below the Agency's level of concern
of 100% of the cPAD.
3. Short- and intermediate- term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short- and intermediate-term adverse effects were identified;
however, residential exposures anticipated from the registered uses are
not applicable for the aggregate risk assessment because no dermal
hazard was identified. Therefore, the short-term and intermediate-term
aggregate risks are equivalent to the chronic dietary risk estimates,
which are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyprodinil is classified as ``not likely to be carcinogenic to
humans.'' Therefore, cyprodinil is not expected to pose an aggregate
cancer risk to humans.
5. Determination of safety. Based on the risk assessments and
information described above, EPA concludes there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to cyprodinil residues.
More detailed information on this action can be found in the Cyprodinil
Human Health Risk Assessment in docket ID EPA-HQ-OPP-2022-0645.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available for enforcing
tolerances of cyprodinil in/on plant commodities, specifically high
performance liquid chromatography with UV detection (HPLC/UV) method
with column switching. Method AG-631B also contains procedures for
confirmatory analysis by gas chromatography with nitrogen phosphorus
detection (GC/NPD).
The methods 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#770512041e1302121a12031f1813043712071659101801"><span class="__cf_email__" data-cfemail="a0d2c5d3c9c4d5c5cdc5d4c8cfc4d3e0c5d0c18ec7cfd6">[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 Codex has established MRLs for cyprodinil in or on berries and
other small fruits (except grapes) at 10 ppm, based on U.S. raspberry
residue data reflecting foliar applications. These Codex MRLs are
different than the tolerance being established for residues of
cyprodinil in the United States because the U.S. tolerance for residues
in/on cranberry at 0.4 ppm is based on newly submitted cranberry field
trial data that reflects a longer 30-day PHI, whereas the Codex MRL is
based on a 0-day PHI. Because the use pattern is different resulting in
significantly different residue levels, the U.S. tolerance will not be
harmonized with the existing Codex MRLs.
V. Conclusion
Therefore, a tolerance is established for residues of cyprodinil,
including its metabolites and degradates, in or on the raw agricultural
commodity cranberry at 0.4 ppm.
Additionally, EPA is making a housekeeping correction to a separate
tolerance provision. In 2010, the tolerance expression in the
introductory paragraph of 40 CFR 180.582, which contains tolerances for
pyraclostrobin,
[[Page 10702]]
was erroneously revised to refer to ``pyradostrobin'' as the pesticide
chemical, instead of ``pyraclostrobin''. See 75 FR 42324 (July 21,
2010). Up until that date, the rule had always referred to
``pyraclostrobin'', since that is the correct name of the pesticide
chemical that is the subject of that rulemaking, and all preambles to
subsequent rulemakings revising Sec. 180.582, have referred to
``pyraclostrobin''. The misnomer was a result of a typographical error,
which EPA is correcting at this time. Since this change has no
substantive effect, it can be accomplished without further notice and
comment.
VI. Statutory and Executive Order Reviews
This action establishes tolerances 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 tolerance 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).
VII. 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: February 10, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.532 is amended by adding in alphabetical order to table
1 to paragraph (a) the entry ``Cranberry''.
The addition reads as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cranberry.................................................. 0.4
* * * * *
------------------------------------------------------------------------
* * * * *
0
3. Section 180.582 is amended by removing ``pyradostrobin'' and adding
in its place ``pyraclostrobin'' in paragraph (a)(1) introductory text.
* * * * *
[FR Doc. 2025-03001 Filed 2-25-25; 8:45 am]
BILLING CODE 6560-50-P
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