86268 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA or other 

laws. As noted in the above section 

regarding the applicability of the APA, 

DEA determined that there was good 

cause to exempt this final rule from 

notice and comment. Consequently, the 

RFA does not apply. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521. This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1532, DEA has determined that 

this action would not result in any 

Federal mandate that may result ‘‘in the 

expenditure by State, local, and Tribal 

Governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year.’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under UMRA of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of this rule to both Houses of 

Congress and to the Comptroller 

General. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 7, 2023, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

amends 21 CFR part 1308 as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b), unless otherwise noted. 

■ 2. Amend § 1308.11 by adding new 

paragraphs (d)(102) to (104) to read as 

follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

*******

(102) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H-indazole-3-carboxamide (other name: ADB–BUTINACA) ............................ 7027 

(103) 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (other names: a-PiHP; alpha-PiHP) .................................................................... 7551 

(104) 2-(methylamino)-1-(3-methylphenyl)propan-1-one (other names: 3–MMC; 3-methylmethcathinone) ............................................... 1259 

* * * * * * * 

* * * * * 

[FR Doc. 2023–27292 Filed 12–12–23; 8:45 am] 

BILLING CODE 4410–09–P 

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. 

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: RDFRNotices@epa.gov. 

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). 


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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 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-sendcomments-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-effectlevels (NOAELs) and the lowestVerDate Sep<11>2014 15:50 Dec 12, 2023 Jkt 262001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\13DER1.SGM 13DER1

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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-andassessing-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 


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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 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-scienceand-assessing-pesticide-risks/modelspesticide-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 mg 

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 nonoccupational, 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-andassessing-pesticide-risks/cumulativeassessment-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 


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86272 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 

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 nonoccupational 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: residuemethods@

epa.gov. 

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. 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Rules and Regulations 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Revise § 180.172 to read as follows: 

§ 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) 

Commodity Parts 

per 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 


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