44618 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0066; FRL–8671–01– 

OCSPP] 

Emamectin benzoate; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of emamectin 

benzoate in or on soybean, seed. 

Syngenta Crop Protection, LLC, 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 13, 2021. Objections and 

requests for hearings must be received 

on or before October 12, 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–2021–0066, 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, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, 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–2021–0066 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 12, 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– 

2019–0387, 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 March 22, 

2021 (86 FR 15162) (FRL–10021–44), 

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 9F8817) by 

Syngenta Crop Protection, LLC, 410 

Swing Road, Greensboro, NC 27409. The 

petition requested that 40 CFR part 180 

be amended by establishing a tolerance 

for residues of insecticide emamectin 

benzoate (a mixture of a minimum of 

90% 4′-epi-methylamino-4′- 

deoxyavermectin B1a and a maximum 

of 10% 4′-epi-methylamino4′deoxyavermectin B1b benzoate), and 

its metabolites 8,9 isomer of the B1a and 

B1b component of the parent insecticide 

in or on soybean, seed at 0.01 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

LLC, the registrant, which is available in 

the docket, https://www.regulations.gov/ 

docket/EPA-HQ-OPP-2021-0066. There 

were no comments received in response 

to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 


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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 44619 

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 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 emamectin 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with emamectin follows. 

In an effort to streamline Federal 

Register publications, EPA is not 

reprinting sections of the rule that 

would repeat what has been previously 

published in tolerance rulemakings for 

the same pesticide chemical. Where 

scientific information concerning a 

particular chemical remains unchanged, 

the content of those sections would not 

vary between tolerance rulemakings, 

and republishing the same sections is 

unnecessary. EPA considers referral 

back to those sections as sufficient to 

provide an explanation of the 

information EPA considered in making 

its safety determination for the new 

rulemaking. 

EPA has previously published a 

number of tolerance rulemakings for 

emamectin, in which EPA concluded, 

based on the available information, that 

there is a reasonable certainty that no 

harm would result from aggregate 

exposure to emamectin and established 

tolerances for residues of that chemical. 

EPA is incorporating previously 

published sections from those 

rulemakings as described further in this 

rulemaking, as they remain unchanged. 

Toxicological profile. The 

Toxicological Profile of emamectin 

remains unchanged from the 

Toxicological Profile in Unit III.A. of the 

August 27, 2019 rulemaking (84 FR 

44718) (FRL–9997–10). Refer to that 

section for a discussion of the 

Toxicological Profile of emamectin. 

Toxicological points of departure/ 

Levels of concern. The Toxicological 

Points of Departure/Levels of Concern 

used for the safety assessment remain 

unchanged from Unit III.B. of the 

August 27, 2019 rulemaking. For a 

summary, refer to that discussion. 

Exposure assessment. Much of the 

exposure assessment remains the same, 

although updates have occurred to 

accommodate exposures from the 

petitioned-for tolerance. These updates 

are discussed in this section; for a 

description of the rest of the EPA 

approach to and assumptions for the 

exposure assessment, see Unit III. C. of 

the August 27, 2019 rulemaking. 

EPA’s dietary exposure assessments 

have been updated to include the 

additional exposure from the new use of 

emamectin on soybean, seed. All other 

assumptions in the exposure 

assessments for emamectin remain the 

same as in the August 27, 2019 

rulemaking. 

Drinking water and non-occupational 

exposures. Drinking water exposures 

and residential (non-occupational) 

exposures are not impacted by the new 

use, and thus have not changed since 

the last assessment. 

There are no proposed residential 

uses of emamectin that would result in 

residential exposures. As a result, there 

are no residential risk estimates 

recommended for use in the aggregate 

risk assessment for emamectin. 

Cumulative exposures. 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.’’ 

For the new uses of emamectin, the 

quantitative exposures to residues of 

emamectin remain unchanged, and the 

cumulative exposures remain identical 

to those as assessed within the 2021 

cumulative assessment. There are no 

risks of concern resulting from these 

cumulative exposures. 

Safety factor for infants and children. 

The scientific information underpinning 

EPA’s prior safety factor determination 

remains unchanged from the August 27, 

2019 rulemaking. EPA continues to 

conclude that there is reliable data to 

support the reduction of the Food 

Quality Protection Act (FQPA) safety 

factor. See Unit III.D. of the August 27, 

2019 rulemaking for a discussion of the 

Agency’s rationale for that 

determination. 

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). 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

points of departure to ensure that an 

adequate margin of exposure (MOE) 

exists. For linear cancer risks, EPA 

calculates the lifetime probability of 

acquiring cancer given the estimated 

aggregate exposure. 

Acute dietary risks are below the 

Agency’s level of concern: 30% of the 

acute population adjusted dose (aPAD) 

for children 1 to 2 years old, the 

population group of concern. Chronic 

dietary risks are below the Agency’s 

level of concern: 3.8% of the chronic 

population adjusted dose (cPAD) for 

children 1 to 2 years old, the group with 

the highest exposure. Emamectin is 

classified as ‘‘Not likely to be 

Carcinogenic to Humans’’, therefore, a 

cancer dietary exposure analysis was 

not performed. 

There are no registered uses of 

emamectin that would result in 

residential exposure; therefore, 

aggregate exposure and risk estimates 

are equivalent to the dietary exposure 

and risk estimates and are not of 

concern. Using the exposure 

assumptions described for acute and 

chronic exposures, EPA has concluded 

the combined dermal and inhalation 

exposures result in aggregate margins of 

exposures for handler scenarios ranging 

from 200 to 27,000 and post-application 

scenarios ranging from 48,000 to 

750,000, which are not of concern 

because they exceed EPA’s level of 

concern (MOEs less than or equal to 

100). 

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 emamectin residues. More 

detailed information about the Agency’s 

analysis can be found at http://

www.regulations.gov in the document 

titled ‘‘Emamectin Benzoate; Human 

Health Risk Assessment for a Proposed 

New Use on Soybean’’ in docket ID 

number EPA–HQ–OPP–2021–0066. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For a discussion of the available 

analytical enforcement method, see Unit 

IV.A. of the August 27, 2019 

rulemaking. 

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 has not established MRLs 

for residues of emamectin on soybeans. 


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44620 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of emamectin benzoate (a 

mixture of a minimum of 90% 4′-epimethylamino-4′-deoxyavermectin B1a 

and a maximum of 10% 4′-epimethlyamino-4′deoxyavermectin B1b 

benzoate) and its metabolites in or on in 

or on the soybean, seed at 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

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: July 29, 2021. 

Marietta Echeverria, 

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: 

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 § 180.505, add alphabetically the 

entry ‘‘Soybean, seed’’ to table 1 to 

paragraph (a)(1) to read as follows: 

§ 180.505 Emamectin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

* * * * * 

Soybean, seed ............................ 0.01 

* * * * * 

* * * * * 

[FR Doc. 2021–17184 Filed 8–12–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0450; FRL–8672–01– 

OCSPP] 

Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6- 

bis(4-chlorophenyl)-2,5-dihydro-; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of pyrrolo[3,4- 

c]pyrrole-1,4-dione, 3,6-bis(4- 

chlorophenyl)-2,5-dihydro- when used 

as an inert ingredient (dye, coloring 

agent) in pesticide formulations applied 

to growing crops or to raw agricultural 

commodities after harvest. BASF 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance for 

pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6- 

bis(4-chlorophenyl)-2,5-dihydro-. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of pyrrolo[3,4-c]pyrrole-1,4- 

dione, 3,6-bis(4-chlorophenyl)-2,5- 

dihydro- when used in accordance with 

this exemption. 

DATES: This regulation is effective 

August 13, 2021. Objections and 

requests for hearings must be received 

on or before October 12, 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–2020–0450, 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 


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