48308 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting only three hours and 30 

minutes that will prohibit entry within 

250-yard radius of where the fireworks 

display will be conducted. It is 

categorically excluded from further 

review under paragraph L[60] of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and record keeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 165.T09–0576 to read as 

follows: 

§ 165.T09–0576 Safety Zone; Maumee 

River; Toledo, OH 

(a) Location. The following area is a 

safety zone: All U.S. navigable waters of 

the Maumee River within a within a 

250-yard radius of the fireworks launch 

site located at position 41°38′54′′ N 

83°31′54′′ W. All geographic coordinates 

are North American Datum of 1983 

(NAD 83). 

(b) Enforcement period. This 

regulation will be enforced from 7:30 

p.m. through 11 p.m. on September 3, 

2021. The Captain of the Port Detroit, or 

a designated representative may 

suspend enforcement of the safety zone 

at any time. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23 of 

this part, entry into, transiting or 

anchoring within this safety zone is 

prohibited unless authorized by the 

Captain of the Port Detroit, or his 

designated representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Detroit or his designated representative. 

(3) The ‘‘designated representative’’ of 

the Captain of the Port Detroit is any 

Coast Guard commissioned, warrant, or 

petty officer who has been designated 

by the Captain of the Port Detroit to act 

on their behalf. The designated 

representative of the Captain of the Port 

Detroit will be aboard either a Coast 

Guard or Coast Guard Auxiliary vessel. 

The Captain of the Port Detroit or a 

designated representative may be 

contacted via VHF Channel 16. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port Detroit 

or a designated representative to obtain 

permission to do so. Vessel operators 

given permission to enter or operate in 

the safety zone must comply with all 

directions given to them by the Captain 

of the Port Detroit or a designated 

representative. 

Dated: August 25, 2021. 

Brad W. Kelly, 

Captain, U.S. Coast Guard, Captain of the 

Port Detroit. 

[FR Doc. 2021–18642 Filed 8–27–21; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0054; FRL–8750–02– 

OCSPP] 

Thiabendazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiabendazole 

in or on multiple commodities that are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 30, 2021. Objections and 

requests for hearings must be received 

on or before October 29, 2021, 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–2020–0054, is 

available at http://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 is (202) 566–1744, 


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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations 48309 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health emergency, 

the EPA Docket Center (EPA/DC) and 

Reading Room is closed to visitors with 

limited exceptions. The staff continues 

to provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

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). 

• 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 Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can 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 

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–2020–0054 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 

October 29, 2021. 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– 

2020–0054, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

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 http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of June 28, 

2021 (86 FR 33922) (FRL–10025–08), 

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 9E8812) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested EPA to establish tolerances in 

40 CFR 180.242 for residues of 

thiabendazole (2-(4- 

thiazolyl)benzimidazole), including its 

metabolites and degradates, in or on the 

following raw agricultural commodities: 

Animal feed, nongrass, group 18 at 0.01 

parts per million (ppm); Beet, garden, 

leaves at 0.01 ppm; Brassica, leafy 

greens, subgroup 4–16B at 0.01 ppm; 

Burdock, edible, leaves at 0.01 ppm; 

Carrot, leaves at 0.01 ppm; Carrot, roots 

at 10 ppm; Celeriac, leaves at 0.01 ppm; 

Chervil, turnip rooted, leaves at 0.01 

ppm; Chicory, leaves at 0.01 ppm; Fruit, 

citrus, group 10–10 at 10 ppm; Fruit, 

pome, group 11–10 at 10 ppm; Kohlrabi 

at 0.01 ppm; Radish, oriental, leaves at 

0.01 ppm; Rutabaga, leaves at 0.01 ppm; 

Salsify, black, leaves at 0.01 ppm; Sweet 

potato, tuber at 3 ppm; Vegetable, 

Brassica, head and stem, group 5–16 at 

0.01 ppm; Vegetable, root, except sugar 

beet, subgroup 1B at 0.01 ppm; 

Vegetable, tuberous and corm, subgroup 

1C, except sweet potato at 10 ppm. 

The petition also proposed to remove 

the established tolerances for residues of 

thiabendazole (2-(4- 

thiazolyl)benzimidazole), including its 

metabolites and degradates, in or on the 

following raw agricultural commodities: 

Potato, postharvest at 10.0 ppm; Sweet 

potato (postharvest to sweet potato 

intended only for use as seed) at 0.05 

ppm; Alfalfa, forage at 0.02 ppm; 

Alfalfa, hay at 0.02 ppm; Radish, tops at 

0.02 ppm; Brassica, head and stem, 

subgroup 5A at 0.02 ppm; Fruit, citrus, 

group 10, postharvest at 10.0 ppm; 

Fruit, pome, group 11, postharvest at 5.0 

ppm; Vegetable, root (except sugarbeet), 

subgroup 1B at 0.02 ppm; Carrot, roots, 

postharvest at 10.0 ppm; and in 

paragraph (b) Sweet potato at 10 ppm. 

That document referenced a summary 

of the petition prepared by Syngenta 

Crop Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. No comments 

were received in response to the notice 

of filing. 

A previous notice of filing was 

published in the Federal Register of 

April 15, 2020 (85 FR 20910) (FRL– 

10006–54). The April 15, 2020 notice is 

superseded by the June 28, 2021 notice. 

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. . . .’’ 


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Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 thiabendazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with thiabendazole 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. 

Decreased body weight is the most 

sensitive effect of exposure to 

thiabendazole observed even in young 

rat pups during lactation. 

Histopathological changes in the spleen 

(congestion and pigmentation) and 

kidney (calculus and hyperplasia of 

transitional epithelium) were noted in a 

subchronic rat study, and splenic 

erythropoiesis and hemosiderosis were 

reported in a chronic dog study. Other 

target organs of thiabendazole toxicity 

are the liver and thyroid. Increased 

quantitative susceptibility was observed 

in the rat and rabbit developmental 

toxicity studies, in which 

developmental effects occurred in the 

absence of maternal toxicity. Increased 

quantitative susceptibility was not 

observed in the prenatal developmental 

toxicity study in mice and in the 2- 

generation reproduction study in rats. In 

an acute neurotoxicity rat study (ACN), 

reduced locomotor activity was 

identified, although no morphological 

or histopathological effects were noted 

in the brain. No signs of neurotoxicity 

were seen in the subchronic 

neurotoxicity study. Thiabendazole is 

classified as ‘‘Likely to be carcinogenic 

to humans at doses high enough to 

cause a disturbance of the thyroid 

hormonal balance. It is not likely to be 

carcinogenic at doses lower than those 

which could cause a disturbance of this 

hormonal balance’’. 

Additional information on the 

toxicological profile can be found at 

http://www.regulations.gov in the 

document titled ‘‘Thiabendazole: 

Human Health Risk Assessment for the 

Establishment of Permanent Tolerances 

and Registration for Use on Animal 

feed, nongrass, group 18; Brassica, leafy 

greens, subgroup 4–16B; and Sweet 

Potato; and Crop Group Conversions/ 

Expansions to Fruit, citrus, group 10– 

10; Fruit, pome, group 11–10; Kohlrabi; 

Vegetable, Brassica, head and stem, 

group 5–16; Vegetable, root, except 

sugar beet, subgroup 1B; and Vegetable, 

tuberous and corm, subgroup 1C, except 

sweet potato’’ (hereinafter 

‘‘Thiabendazole Human Health Risk 

Assessment’’) in docket ID number 

EPA–HQ–OPP–2020–0054. 

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 http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. 

A summary of the toxicological 

endpoints for thiabendazole used for 

human risk assessment can be found in 

the Thiabendazole Human Health Risk 

Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiabendazole, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from thiabendazole 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. 

In conducting the acute dietary 

exposure assessment, EPA used the 

2003–2008 food consumption data from 

the U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). The acute 

dietary exposure assessment is partially 

refined and incorporated established 

and recommended tolerance-level 

residues for some commodities, 

maximum field trial residues for the 

remaining commodities according to 

blending classification, 100 percent crop 

treated (PCT), and default processing 

factors (except for apple juice, grapefruit 

juice, lemon juice, lime juice, orange 

juice, pear juice, potato granules/flakes, 

and tangerine juice). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the USDA’s 

NHANES/WWEIA. The chronic dietary 

exposure assessment is partially refined 

and incorporated established and 

recommended tolerance-level residues 

for some commodities, average field 

trial residues for the remaining 

commodities according to blending 

classification, 100 PCT, and default 

processing factors (except for apple 

juice, grapefruit juice, lemon juice, lime 

juice, orange juice, pear juice, potato 

granules/flakes, and tangerine juice). 

iii. Cancer. Thiabendazole is 

classified as ‘‘Likely to be carcinogenic 

at doses high enough to cause a 

disturbance of the thyroid hormonal 

balance but not likely to be carcinogenic 

at doses lower than those which could 

cause a disturbance of this hormonal 

balance.’’ EPA is regulating chronic 

exposure based on a reference dose that 

is lower than (and thus protective of) 

the level that would cause a disturbance 

in the thyroid hormonal balance, 

making tumor formation highly 

unlikely; therefore, a cancer dietary 

exposure assessment is not required. 

The current partially refined chronic 

dietary risk assessment is conservative 

and is protective for cancer effects. 

iv. Anticipated residue and PCT 

information. EPA used some tolerancelevel residues and some anticipated 

residue data for assessing tolerances. 

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 


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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. 

EPA did not use PCT estimates in the 

dietary assessment for thiabendazole; 

100 PCT was assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for thiabendazole in drinking water. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the FQPA Index Reservoir 

Screening Tool (FIRST; surface water) 

model and the Pesticide Root Zone 

Model for Ground Water (PRZM–GW; 

groundwater), EPA used an estimated 

drinking water concentration (EDWC) of 

3.80 ppb for the acute dietary risk 

assessment and a value of 0.47 ppb for 

the chronic dietary risk assessment. 

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). 

Thiabendazole is currently registered 

for uses that may result in residential 

handler and post-application exposures, 

including use in paints and textiles. As 

an initial matter in assessing aggregate 

risk of the pesticide chemical residues, 

the Agency takes into consideration 

those residential exposure scenarios that 

provide the most conservative estimate 

of residential exposures, including 

handler exposure and post-application 

exposure or both. 

The residential handler exposure 

scenario used in the aggregate 

assessment is for adult handler 

inhalation exposures from applying 

thiabendazole-treated paint using airless 

sprayers. For this scenario, the 

Aggregate Risk Index (ARI) approach 

was used since the PODs/endpoints 

were similar, but the levels of concern 

(LOCs) were different. An ARI greater 

than or equal to 1 is not of concern. 

The residential exposure scenario 

used for the post-application assessment 

is incidental oral exposures from 

children 1 to <2 years old mouthing 

preserved textiles (clothing) treated with 

thiabendazole. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-pesticide. 

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 

thiabendazole and any other substances 

and thiabendazole does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that thiabendazole has a 

common mechanism of toxicity with 

other substances. 

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 

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. 

The data submitted to the Agency, as 

well as those from published literature, 

demonstrated increased quantitative 

susceptibility in the rat and rabbit 

developmental toxicity studies, in 

which developmental effects (decreased 

fetal weights in rat and rabbit pups) 

were observed while maternal toxicity 

was not observed up to the highest 

doses tested. No increased susceptibility 

was observed in mice in utero and/or to 

rats following early postnatal exposure 

to thiabendazole. 

3. Conclusion. EPA has determined 

there is reliable data to support a 

conclusion that a FQPA Safety Factor 

(SF) of 1X will be protective for infants 

and children for all scenarios, with the 

exception of the assessment of 

inhalation exposure. The default FQPA 

10X SF remains in place for assessing 

the non-occupational inhalation 

exposure due to the lack of a subchronic 

inhalation study with thyroid 

measurements. That decision is based 

on the following findings: 

i. The toxicology database for 

thiabendazole is complete with the 

exception of a subchronic inhalation 

toxicity study with thyroid 

measurements. Based on a weight of 

evidence approach considering all the 

available hazard and exposure 

information for thiabendazole, the 

Agency determined that a 

developmental thyroid toxicity study is 

not required at this time. Acceptable 

studies are available for developmental, 

reproduction, chronic, subchronic, 

subchronic neurotoxicity and 

immunotoxicity. 

ii. In an acute neurotoxicity rat study 

(ACN), reduced locomotor activity in 

males and females at time of peak effect 

(approximately 3 hours post-dose) were 

seen without morphological or 

histopathological effects on the brain. 

Thiabendazole was not neurotoxic in 

rats in a subchronic neurotoxicity study 

at the highest dose tested (1,500 ppm 

equivalent to 95 mg/kg/day). 

iii. As noted above, there is some 

evidence of increased susceptibility in 

the developmental fetus from exposure 

to thiabendazole. Nevertheless, the 

Agency has sufficient data to 

understand and protect against the 

potential developmental effects. The 

data indicating the potential for 

developmental toxicity presented welldefined NOAELs and LOAELs, which 

the Agency took into account when 

identifying endpoints. The selected 

points of departure for regulating 

exposure are protective of both the 

potential for neurotoxicity and the 

increased susceptibility of infants and 

children. There is no residual 

uncertainty concerning the potential for 

prenatal or post-natal toxicity that 

precludes the reduction of the FPQA 

10X SF. 

iv. There are no residual uncertainties 

in the exposure database. The dietary 

risk assessment is conservative and will 

not underestimate dietary and/or nondietary occupational exposure to 

thiabendazole. The acute and chronic 

dietary assessments conducted were 

slightly refined analyses. The 

assessments utilized tolerance-level 

residues, maximum residue or average 


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residue values from field-trial data, 

empirical or EPA’s 2018 default 

processing factors, and 100 PCT. The 

analysis also used Tier 1 drinking water 

estimates. For these reasons, it can be 

concluded that the analysis does not 

underestimate risk from acute or 

chronic exposure to thiabendazole. 

Similarly, EPA does not believe that the 

non-dietary exposures are 

underestimated because they are also 

based on conservative assumptions. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

described in this unit for acute 

exposure, EPA has concluded that acute 

exposure to thiabendazole from food 

and water will utilize 50% of the aPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thiabendazole 

from food and water will utilize 64% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Thiabendazole is 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

thiabendazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate ARI of 1.88 for adults and an 

MOE of 200 for children 1 to 2 years 

old. Because EPA’s level of concern for 

thiabendazole is an ARI of less than or 

equal to 1 or an MOE of 100 or below, 

these ARIs/MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, thiabendazole 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

thiabendazole. 

5. Aggregate cancer risk for U.S. 

population. As the risks estimated based 

on the chronic reference dose are 

protective of cancer effects, no separate 

cancer risk assessment is necessary. The 

chronic dietary aggregate risk 

assessment is below the Agency’s level 

of concern; therefore, the Agency 

concludes that aggregate exposure to 

thiabendazole is not likely to pose a 

cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

thiabendazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate spectrophotofluorometric 

methods are available in the Pesticide 

Analytical Manual, Volume II (PAM II) 

for enforcement of thiabendazole 

tolerances. 

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 more restrictive 

(i.e., lower) MRLs for residues in/on 

citrus fruits and pome fruits (7 ppm and 

3 ppm respectively, versus the existing 

U.S. tolerances for the old crop groups, 

which are 10.0 ppm for citrus and 5.0 

ppm for pome fruit.) Therefore, 

harmonization with the Codex MRLs are 

not possible because U.S. growers 

would be at risk of violative residues of 

thiabendazole despite legal use 

according to the label. Instead, EPA is 

harmonizing the tolerance for fruit, 

pome, group 11–10 with the Canadian 

MRL of 10 ppm in/on apples and pears. 

Additionally, Codex has established an 

MRL for residues in/on potato at 15 

ppm, which is higher than the revised 

U.S. tolerance of 10 ppm. Per the 

registrant’s request, the Agency is not 

harmonizing with the established Codex 

MRL for residues in/on potato. Instead, 

the U.S. tolerance is harmonized with 

the Canadian MRL for potatoes at 10 

ppm because Canada is a major trading 

partner with the United States for 

potatoes. 

C. Revisions to Petitioned-For 

Tolerances 

As mentioned in Unit II., the 

petitioner requested that the timelimited tolerance in § 180.242(b) at 10 

ppm for residues of thiabendazole in/on 

sweet potato be removed upon the 

establishment of a permanent tolerance 

for residues of thiabendazole in/on 

sweet potato in § 180.242(a). EPA is not 

removing the time-limited tolerance on 

sweet potato in § 180.242(b) due to a 

difference between the section 18 use 

pattern and the proposed use pattern for 

the section 3 registration. There is a 

potential that use under the current 

section 18 could result in exceedances 

if this tolerance was revoked. 

D. International Trade Considerations 

In this rule, EPA is establishing 

tolerances for thiabendazole residues in 

or on the Animal feed, nongrass, group 

18; Vegetable, Brassica, head and stem, 

group 5–16; and the Vegetable, root, 

except sugar beet, subgroup 1B (all at 

0.01 ppm) that are lower than the 

current tolerances of Alfalfa forage, 

Alfalfa hay, Brassica head and stem 


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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations 48313 

subgroup 5A, and Vegetable, root 

(except sugarbeet), subgroup 1B (all 0.02 

ppm). For the reasons explained in the 

Thiabendazole Human Health Risk 

Assessment, the Agency believes these 

revised, lower tolerances are 

appropriate. 

In accordance with the World Trade 

Organization’s (WTO) Sanitary and 

Phytosanitary Measures (SPS) 

Agreement, EPA intends to notify the 

WTO of the changes to these tolerances 

in order to satisfy its obligations under 

the Agreement. In addition, the SPS 

Agreement requires that Members 

provide a ‘‘reasonable interval’’ between 

the publication of a regulation subject to 

the Agreement and its entry into force 

to allow time for producers in exporting 

Member countries to adapt to the new 

requirement. Accordingly, EPA is 

establishing an expiration date for the 

existing tolerances to allow these 

tolerances to remain in effect for a 

period of six months after the effective 

date of this final rule. After the sixmonth period expires, these tolerances 

will be reduced or revoked, as indicated 

in the regulatory text, and allowable 

residues on alfalfa forage, alfalfa hay, 

Brassica head and stem subgroup 5A, 

and vegetable, root (except sugarbeet), 

subgroup 1B must conform to the 

tolerances for Animal feed, nongrass, 

group 18; Vegetable, Brassica, head and 

stem, group 5–16; and Vegetable, root, 

except sugar beet, subgroup 1B. This 

reduction in tolerance level is not 

discriminatory; the same food safety 

standard contained in the FFDCA 

applies equally to domestically 

produced and imported foods. The new 

tolerance levels are supported by 

available residue data. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thiabendazole in or on 

Animal feed, nongrass, group 18 at 0.01 

ppm; Beet, garden, leaves at 0.01 ppm; 

Brassica, leafy greens, subgroup 4–16B 

at 0.01 ppm; Burdock, edible, leaves at 

0.01 ppm; Carrot, leaves at 0.01 ppm; 

Carrot, roots at 10 ppm; Celeriac, leaves 

at 0.01 ppm; Chervil, turnip rooted, 

leaves at 0.01 ppm; Chicory, leaves at 

0.01 ppm; Fruit, citrus, group 10–10 at 

10 ppm; Fruit, pome, group 11–10 at 10 

ppm; Kohlrabi at 0.01 ppm; Radish, 

oriental, leaves at 0.01 ppm; Rutabaga, 

leaves at 0.01 ppm; Salsify, black, leaves 

at 0.01 ppm; Sweet potato, tuber at 3 

ppm; Vegetable, Brassica, head and 

stem, group 5–16 at 0.01 ppm; 

Vegetable, root, except sugar beet, 

subgroup 1B at 0.01 ppm; and 

Vegetable, tuberous and corm, subgroup 

1C, except sweet potato at 10 ppm. 

Additionally, the following tolerances 

are removed as unnecessary due to the 

establishment of the above tolerances: 

Alfalfa, forage; Alfalfa, hay; Brassica, 

head and stem, subgroup 5A; Carrot, 

roots, postharvest; Fruit, citrus, group 

10, postharvest; Fruit, pome, group 11, 

postharvest; Potato, postharvest; Radish, 

tops; Sweet potato (postharvest to sweet 

potato intended only for use as seed); 

and Vegetable, root (except sugarbeet), 

subgroup 1B. 

Finally, EPA is revising the tolerance 

expression for thiabendazole in 40 CFR 

180.242(a)(1) and (2) to clarify (1) that, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of thiabendazole not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. EPA has 

determined that it is reasonable to make 

this change final without prior proposal 

and opportunity for comment, because 

public comment is not necessary, in that 

the change has no substantive effect on 

the tolerance, but rather is merely 

intended to clarify the existing tolerance 

expression. 

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.), 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 and modifications 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: August 18, 2021. 

Catherine Aubee, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 


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48314 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations 

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. In § 180.242: 

■ a. Amend paragraph (a)(1) by: 

■ i. Revising the introductory text. 

■ ii. In the table: 

■ A. Adding the heading ‘‘Table 1 to 

Paragraph (a)(1)’’; 

■ B. Removing the entries for ‘‘Alfalfa, 

forage’’; and ‘‘Alfalfa, hay’’; 

■ C. Adding in alphabetical order the 

entries ‘‘Animal feed, nongrass, group 

18’’; and ‘‘Beet, garden, leaves’’; 

■ D. Removing the entry for ‘‘Brassica, 

head and stem, subgroup 5A’’; 

■ E. Adding in alphabetical order the 

entries ‘‘Brassica, leafy greens, subgroup 

4–16B’’; ‘‘Burdock, edible, leaves’’; 

‘‘Carrot, leaves’’; and ‘‘Carrot, roots’’; 

■ F. Removing the entry for ‘‘Carrot, 

roots, postharvest’’; 

■ G. Adding in alphabetical order the 

entries ‘‘Celeriac, leaves’’; ‘‘Chervil, 

turnip rooted, leaves’’; ‘‘Chicory, 

leaves’’; and ‘‘Fruit, citrus, group 10– 

10’’; 

■ H. Removing the entry for ‘‘Fruit, 

citrus, group 10, postharvest’’; 

■ I. Adding the entry ‘‘Fruit, pome, 

group 11–10’’; 

■ K. Removing the entry for ‘‘Fruit, 

pome, group 11, postharvest’’; 

■ L. Adding in alphabetical order the 

entry ‘‘Kohlrabi’’; 

■ M. Removing the entry for ‘‘Potato, 

postharvest’’; 

■ N. Adding in alphabetical order the 

entry ‘‘Radish, oriental, leaves’’; 

■ O. Removing the entry for ‘‘Radish, 

tops’’; 

■ P. Adding in alphabetical order the 

entries ‘‘Rutabaga, leaves’’; and ‘‘Salsify, 

black, leaves’’; 

■ Q. Removing the entry for ‘‘Sweet 

potato (postharvest to sweet potato 

intended only for use as seed)’’; 

■ R. Adding in alphabetical order the 

entries ‘‘Sweet potato, tuber’’; 

‘‘Vegetable, Brassica, head and stem, 

group 5–16’’; and ‘‘Vegetable, root, 

except sugar beet, subgroup 1B’’; 

■ S. Removing the entry for ‘‘Vegetable, 

root (except sugarbeet), subgroup 1B’’; 

■ T. Adding in alphabetical order the 

entry ‘‘Vegetable, tuberous and corm, 

subgroup 1C, except sweet potato’’ and 

■ b. Amend paragraph (a)(2) by: 

■ i. Revising the introductory text. 

■ ii. In the table, adding the heading 

‘‘Table 2 to Paragraph (a)(2)’’. 

■ The additions and revisions read as 

follows: 

§ 180.242 Thiabendazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

thiabendazole, including its metabolites 

and degradates, in or on the 

commodities in table 1 to paragraph 

(a)(1). Compliance with the tolerance 

levels specified to table 1 to paragraph 

(a)(1) is to be determined by measuring 

only thiabendazole in or on the 

commodity. 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

Alfalfa, forage 1 .................................................................................................................................................................................... 0.02 

Alfalfa, hay 1 ......................................................................................................................................................................................... 0.02 

Animal feed, nongrass, group 18 ........................................................................................................................................................ 0.01 

* * * * * * * 

Beet, garden, leaves ............................................................................................................................................................................ 0.01 

Brassica, head and stem, subgroup 5A1 ............................................................................................................................................ 0.02 

Brassica, leafy greens, subgroup 4–16B ............................................................................................................................................ 0.01 

Burdock, edible, leaves ....................................................................................................................................................................... 0.01 

*******

Carrot, leaves ...................................................................................................................................................................................... 0.01 

Carrot, roots ......................................................................................................................................................................................... 10 

Celeriac, leaves ................................................................................................................................................................................... 0.01 

Chervil, turnip rooted, leaves ............................................................................................................................................................... 0.01 

Chicory, leaves .................................................................................................................................................................................... 0.01 

*******

Fruit, citrus, group 10–10 .................................................................................................................................................................... 10 

Fruit, pome, group 11–10 .................................................................................................................................................................... 10 

Kohlrabi ................................................................................................................................................................................................ 0.01 

*******

Radish, oriental, leaves ....................................................................................................................................................................... 0.01 

Rutabaga, leaves ................................................................................................................................................................................. 0.01 

Salsify, black, leaves ........................................................................................................................................................................... 0.01 

Sweet potato, tuber ............................................................................................................................................................................. 3 

*******

Vegetable, Brassica, head and stem, group 5–16 .............................................................................................................................. 0.01 

*******

Vegetable, root, except sugar beet, subgroup 1B .............................................................................................................................. 0.01 

Vegetable, root, except sugar beet, subgroup 1B1 ............................................................................................................................ 0.02 

Vegetable, tuberous and corm, subgroup 1C, except sweet potato ................................................................................................... 10 

* * * * * * * 

1This tolerance expires on February 28, 2022. 


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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations 48315 

(2) Tolerances are established for 

residues of thiabendazole, including its 

metabolites and degradates, in or on the 

commodities in table 2 to paragraph 

(a)(2). Compliance with the tolerance 

levels specified to table 2 to paragraph 

(a)(2) is to be determined by measuring 

only the sum of thiabendazole (2-(4- 

thiazolyl)benzimidazole) and its 

metabolite 5-hydroxythiabendazole (free 

and conjugated) calculated as the 

stoichiometric equivalent of 

thiabendazole, in or on the commodity. 

TABLE 2 TO PARAGRAPH (a)(2) 

* * * * * 

[FR Doc. 2021–18390 Filed 8–27–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0523; FRL–5993–04– 

OCSPP] 

Chlorpyrifos; Tolerance Revocations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: On April 29, 2021, the United 

States Court of Appeals for the Ninth 

Circuit ordered EPA to issue a final rule 

concerning the chlorpyrifos tolerances 

by August 20, 2021. Based on the 

currently available data and taking into 

consideration the currently registered 

uses for chlorpyrifos, EPA is unable to 

conclude that the risk from aggregate 

exposure from the use of chlorpyrifos 

meets the safety standard of the Federal 

Food, Drug, and Cosmetic Act (FFDCA). 

Accordingly, EPA is revoking all 

tolerances for chlorpyrifos. 

DATES: This final rule is effective 

October 29, 2021. The tolerances for all 

commodities expire on February 28, 

2022. 

Written objections, requests for 

hearings, or requests for a stay identified 

by the docket identification (ID) number 

EPA–HQ–OPP–2021–0523 must be 

received on or before October 29, 2021, 

and must be filed in accordance with 

the instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION unit in this 

document). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2021–0523, is 

available at http://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. 

Due to public health concerns related 

to COVID–19, the EPA/DC and Reading 

Room are closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Elissa Reaves, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: 703–347–0206; email address: 

OPPChlorpyrifosInquiries@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). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

Other types of entities not listed in 

this unit could also be affected. The 

NAICS codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit II. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the contact 

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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can 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 

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–2021–0523 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 

October 29, 2021. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b), although at this time, EPA 

strongly encourages those interested in 

submitting objections or a hearing 

request, to submit objections and 

hearing requests electronically. See 

Order Urging Electronic Service and 

Filing (April 10, 2020), https://

www.epa.gov/sites/production/files/ 

2020-05/documents/2020-04-10_-_

order_urging_electronic_service_and_

filing.pdf. At this time, because of the 

COVID–19 pandemic, the judges and 

staff of the Office of Administrative Law 

Judges (OALJ) are working remotely and 

not able to accept filings or 

correspondence by courier, personal 

deliver, or commercial delivery, and the 

ability to receive filings or 

correspondence by U.S. Mail is 

similarly limited. When submitting 

documents to the U.S. EPA OALJ, a 

person should utilize the OALJ e-filing 

system, at https://yosemite.epa.gov/OA/ 

EAB/EAB-ALJ_upload.nsf. 

Although EPA’s regulations require 

submission via U.S. Mail or hand 

delivery, EPA intends to treat 

submissions filed via electronic means 

as properly filed submissions during 

this time that the Agency continues to 

maximize telework due to the 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 


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