Document ID: EPA-HQ-OPP-2021-0657-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Dodine
Posted Date: 2023-12-13T05:00Z

[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Rules and Regulations]
[Pages 86268-86273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27254]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0657; FRL-11567-01-OCSPP]

Dodine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of dodine 
in or on Fruit, pome, group 11-10; Fruit, stone, group 12-12; Nut, 
tree, group 14-12; and Olive, with pit. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 13, 2023. Objections and 
requests for hearings must be received on or before February 12, 2024, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0657, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).

[[Page 86269]]

     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Federal Register 
Office's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0657 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 
February 12, 2024. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0657, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-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 
1E8935) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
dodine in or on the raw agricultural commodities: Fruit, pome, group 
11-10 at 5 parts per million (ppm); Fruit, stone, group 12-12 at 5 ppm; 
Nut, tree, group 14-12 at 0.3 ppm; and Olive, with pit at 0.3 ppm.
    The petition also requested to remove the following established 
dodine tolerances in or on: Apple at 5.0 ppm; Fruit, stone, crop group 
12 at 5.0 ppm; Nuts, tree, crop group 14 at 0.3 ppm; and Pear at 5.0 
ppm.
    That document referenced a summary of the petition, which is 
available in the docket, https://www.regulations.gov. Two comments were 
received in response to the notice. EPA's response to these comments 
can be found in section IV.D.
    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 modifying the level at which one of the tolerances is being 
established. For details, see Unit IV.C.

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 dodine including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with dodine 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.
    Because of toxicological equivalency, the Agency must also consider 
any applicable contribution from the antimicrobial pesticide 
dodecylguanidine hydrochloride (DGH). There are no direct food uses 
established for DGH, but there are dietary exposures from uses on paper 
and paperboard and in drinking water from industrial uses.
    A definitive target organ was not identified for dodine or DGH in 
the available toxicology data, with the most common effects being 
decreases in body weight and/or body weight gain. When allometric 
scaling is used to adjust to a human equivalent dosage, the dog was 
found to be the most sensitive species for this endpoint.
    There was no evidence of increased qualitative or quantitative 
susceptibility in pups or fetuses as compared to adults based on rat 
and rabbit developmental studies and a rat multi-generation 
reproduction study. In rat and rabbit prenatal developmental studies, 
there was no toxicity identified in the fetuses up to the highest dose 
tested. In the 2-generation reproduction study, decreases in body 
weight and food consumption were seen in pups at the same dose at which 
maternal toxicity (decreases in body weight, body weight gain, and food 
consumption) was observed. In addition, there was no evidence of 
neurotoxicity across the database. Dodine 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 dodine and DGH as well as the no-observed-
adverse-effect-levels (NOAELs) and the lowest-

[[Page 86270]]

observed-adverse-effect-levels (LOAELs) from the toxicity studies can 
be found in Appendix A of the document titled ``Dodine. Risk Assessment 
for the Proposed Use on Olives; Crop Group Expansions to Fruit Pome 
Group 11-10; and Crop Group Conversions to Stone Fruit Group 12-12 and 
Tree Nut Group 14-12 and Updated Registration Review Human Health Draft 
Risk Assessment'' (hereafter, the Dodine Human Health Risk Assessment), 
in docket ID number EPA-HQ-OPP-2021-0657 at https://www.regulations.gov.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the Toxicological Points of Departure/Levels of 
Concern for dodine used for human health risk assessment can be found 
in Table 4.5.3.1 of the Dodine Human Health Risk Assessment, in docket 
ID number EPA-HQ-OPP-2021-0657 at https://www.regulations.gov.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dodine, EPA considered exposure under the petitioned-for 
tolerances as well as all existing tolerances for dodine in 40 CFR 
180.172. While there are no direct food uses established for DGH, EPA 
considered indirect dietary exposure from use of DGH on paper and 
paperboard in contact with food. EPA assessed dietary exposures from 
dodine 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. No such effects were 
identified in the toxicological studies for dodine or DGH; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. Chronic aggregate dietary exposure and risk 
assessments were conducted using 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). The chronic 
analysis incorporated mean field trial residues for most commodities 
and tolerance-level residues for the remaining commodities. Percent 
crop treated (PCT) data were used for some crops, and 100 PCT was 
assumed for all other crops. The analyses incorporated default 
processing factors for processed commodities where no processing study 
was conducted. For apple juice and olive oil, empirical processing 
factors of 0.1X were used.
    Indirect dietary exposure has the potential to occur from the use 
of DGH as a material preservative in paper and paperboard intended for 
use in contact with food, with a retention rate of up to 0.045% by 
weight of the paper or paperboard. This use is considered protective of 
other indirect food uses, including paper slimicides, materials 
preservative of the outermost ply of multiwalled paper bags containing 
dry food, adhesives and polymers, and sapstain on fruit and vegetable 
containers.
    iii. Cancer. Based on the data summarized in the Dodine Human 
Health Risk Assessment, EPA has concluded that dodine is not likely 
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. Section 408(b)(2)(E) 
of FFDCA 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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     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.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     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 annual average percent crop treated estimates used in the 
chronic dietary risk assessment are as follows: almonds: 2.5%; apples: 
5%; cherries: 20%; nectarines: 1%; peaches: 1%; peanuts: 2.5%; pears: 
2.5%; pecans: 20%; and walnuts: 1%. 100 PCT was assumed for all other 
crops.
    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% as the average PCT value, respectively. 
In those cases, the Agency would use

[[Page 86271]]

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 Conditions a, b, and c discussed above 
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 
dodine 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 dodine in drinking water. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    A chronic surface water estimated drinking water concentration 
(EDWC) of 1.59 parts per billion (ppb) determined with the FQPA Index 
Reservoir Screening Tool (FIRST) was used for dietary assessment. 
Because dodine has a high partition coefficient, is relatively non-
persistent in aerobic soils, and has a lack of transport in the field, 
leaching to groundwater is not expected to be a major route of 
dissipation.
    Drinking water exposure to DGH has the potential to occur when 
drinking water intakes are downstream from cooling towers, paper mills, 
and/or other water systems using DGH as a slimicide. Drinking water 
exposure is expected to be minimal from other currently registered uses 
of DGH such as materials preservation of leather and textiles. The 
highest chronic EDWC from the modeled use patterns is 22 [mu]g ai/L 
from once-through cooling towers using an application rate of 6.0 ppm 
DGH. This drinking water concentration is considered protective of the 
other uses.
    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 current 
or proposed conventional or antimicrobial residential uses of dodine or 
DGH.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to dodine and any other 
substances and dodine does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that dodine has 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 
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    EPA notes that dodine and DGH are salts of the same chemical. They 
dissociate similarly and are considered toxicologically equivalent, as 
opposed to being separate chemicals that share a common mechanism of 
toxicity.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA 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 safety factor. In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional safety 
factor when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
susceptibility following in utero and/or postnatal exposure in the 
developmental toxicity studies in rats or rabbits, nor in the 2-
generation rat reproduction study.
    3. Conclusion. The FQPA safety factor is reduced to 1X for all 
exposure scenarios except for inhalation exposure. The Agency is 
retaining a 10X database uncertainty factor (UFDB) to assess 
risk to dodine inhalation scenarios to account for the lack of an 
acceptable inhalation toxicity study.
    i. Except for an acceptable inhalation toxicity study, the 
toxicology database for dodine and DGH is complete and adequate to 
assess potential risk to infants and children. The database contains 
the following toxicity studies: prenatal developmental studies (rats 
and rabbits); and a reproduction study in rats.
    ii. Neurotoxicity studies are not available for dodine or DGH. 
Clinical signs (excessive salivation and hunched posture/hypoactivity) 
were observed in chronic studies of dodine in rats and mice but were 
not dose-related or statistically significant. Excessive salivation in 
dogs after dodine (capsule) exposure showed a treatment-related dose 
response; however, it was not consistent with a neurological adverse 
effect since it was seen prior to dosing and was a persistent finding 
throughout the study. It is possible that the excessive salivation was 
a result of the irritant properties of dodine. In addition, no evidence 
of neuropathology was observed in the available studies. The Hazard and 
Science Policy Council (HASPOC) recommended waiving the requirement for 
the acute and subchronic neurotoxicity studies, based on (1) the low 
acute oral toxicity of dodine (Toxicity Category III); (2) the lack of 
neurotoxicity in the dodine toxicity database; and (3) no neurotoxicity 
concerns for structurally related compounds to dodine.
    iii. Based on the available dodine and DGH toxicity studies, there 
was no evidence of increased susceptibility (quantitative or 
qualitative) in pups or fetuses as compared to adults based on rat and 
rabbit developmental studies

[[Page 86272]]

and a rat multi-generation reproduction study. In rat and rabbit 
prenatal developmental studies, there was no toxicity identified in the 
fetuses up to the highest dose tested. In the 2-generation reproduction 
study, decreases in body weight and food consumption were seen in pups 
at the same dose at which maternal toxicity (decreases in body weight, 
body weight gain, and food consumption) was observed.
    iv. The exposure databases are sufficient to determine the nature 
and magnitude of the residue in food and drinking water. The dodine 
residue chemistry database is complete. The exposure assessment for 
drinking water provides a conservative approach for estimating dodine 
and DGH concentrations from drinking water sources, and thus is 
unlikely to underestimate exposure. The food and drinking water dietary 
exposure analyses are unlikely to underestimate exposure as they 
incorporated conservative assumptions for dodine and DGH.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary (food and drinking water) 
exposure estimates to the acute population-adjusted dose (aPAD) and 
chronic population-adjusted dose (cPAD). Short- intermediate- and 
chronic-term 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. No adverse effect resulting from a single oral 
exposure was identified and no acute dietary endpoint was selected. 
Therefore, dodine is not expected to pose an acute risk.
    2. Chronic risk. The chronic dietary risk assessment includes only 
food and water exposure from dodine and DGH. Chronic dietary risks from 
dodine (food and drinking water) are below the Agency's level of 
concern of 100% of the cPAD; they are 6.1% of the cPAD for all infants 
less than 1 year old, the group with the highest exposure. Chronic 
dietary risks from DGH (food and water) are below the Agency's level of 
concern of 100% of the cPAD; they are 95% of the cPAD for children 1 to 
2 years old, the group with the highest exposure.
    There are no chronic non-occupational exposures, so the aggregate 
chronic risk assessment is equal to the chronic dietary exposure 
analysis of food and drinking water. The chronic aggregate assessment 
includes: (1) food only contributions from agricultural uses of dodine, 
including the proposed uses; (2) food only contributions from DGH in 
paper and paperboard intended for use in contact with food; and (3) 
drinking water only contributions from DGH in water from cooling tower 
uses, which is protective of drinking water exposures resulting from 
conventional agricultural uses of dodine. This aggregate assessment 
resulted in risk estimates that are below the Agency's level of concern 
of 100% of the cPAD; they are 98% of the cPAD for children 1 to 2 years 
old, the group with the highest exposure, which is considered 
protective for all other population subgroups.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
adverse effects were identified; however, dodine is not registered for 
any use patterns that would result in short- and/or intermediate-term 
residential exposure. Short- and intermediate-term risk is assessed 
based on short- and intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no short-or intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for dodine.
    4. Aggregate cancer risk for U.S. population. There was equivocal 
evidence of carcinogenicity in rat and mouse carcinogenicity studies; 
however, an evaluation of the carcinogenic potential of dodine was 
performed which concluded that the weight of evidence indicates that 
dodine and DGH are ``Not Likely to be Carcinogenic to Humans.'' 
Therefore, dodine and DGH are not expected to pose a cancer risk to 
humans.
    5. Determination of safety. Therefore, 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 
dodine residues. More detailed information on this action can be found 
in the Dodine Human Health Risk Assessment in docket ID EPA-HQ-OPP-
2021-0657.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method 45137, which is entitled ``Dodine: Analytical Method for 
Dodine in Fruit,'' is available for the enforcement of tolerances of 
dodine in/on plant commodities. This method is a Gas Chromatograph/Mass 
Selective Detection (GC/MSD) procedure based on extracting dodine from 
fruit by homogenization with methanol. 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: [email protected].

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.
    Codex has established MRLs for residues of dodine in or on apple at 
5 ppm; pear at 5 ppm; cherry at 3 ppm; nectarine at 5 ppm; and peach at 
5 ppm. The U.S. tolerances are harmonized with the corresponding Codex 
MRLs except for cherry. The cherry field trial data show that residues 
from the domestic labeled use of dodine may exceed the 3 ppm Codex 
cherry MRL. Therefore, it is not possible to harmonize with the Codex 
MRL based on the U.S. application pattern.

C. Revisions to Tolerances

    The Agency is establishing the tolerance level for ``olive, with 
pit'' at 0.4 ppm instead of the requested level of 0.3 ppm. Two of the 
2011 olive trials from Greece were determined to be replicates, and 
this determination resulted in a higher calculated maximum residue 
limit (MRL) than the petitioner requested.

[[Page 86273]]

D. Response to Comments

    Two comments were received in response to the Notice of Filing by 
the same commenter. The commenter stated in part that ``we need to stop 
all chemical use on vegetables'' and that ``toxic in your body kill 
you.'' Although the Agency recognizes that some individuals believe 
that pesticides should be banned on agricultural crops, the existing 
legal framework provided by section 408 of the FFDCA authorizes EPA to 
establish tolerances when it determines that the tolerances are safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that the dodine tolerances are safe. The 
commenter has provided no information indicating that a safety 
determination cannot be supported.

V. Conclusion

    Therefore, tolerances are established for residues of dodine in or 
on Fruit, pome, group 11-10 at 5 ppm; Fruit, stone, group 12-12 at 5 
ppm; Nut, tree, group 14-12 at 0.3 ppm; and Olive, with pit at 0.4 ppm.
    Additionally, the following existing tolerances are removed as 
unnecessary: Apple; Fruit, stone, crop group 12; Nut, tree, crop group 
14; and Pear.

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 to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances 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

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 7, 2023.
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. Revise Sec.  180.172 to read as follows:

Sec.  180.172  Dodine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide dodine, including its metabolites and degradates, in or on 
the commodities in table1 to this paragraph (a). Compliance with the 
tolerance levels specified in table1 is to be determined by measuring 
only dodine, N-dodecylguanidine acetate; in or on the following 
commodities.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hull..............................................          30.0
Apple, wet pomace.........................................          15.0
Banana....................................................          0.50
Fruit, pome, group 11-10..................................             5
Fruit, stone, group 12-12.................................             5
Nut, tree, group 14-12....................................           0.3
Olive, with pit...........................................           0.4
Peanut....................................................         0.013
Strawberry................................................           5.0
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2023-27254 Filed 12-12-23; 8:45 am]
BILLING CODE 6560-50-P