9866 Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 

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: January 19, 2021. 

Edward Messina, 

Acting Director, 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. Add § 180.715 to subpart C to read 

as follows: 

§ 180.715 Fluxametamide; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide fluxametamide, including its 

metabolites and degradates, in or on the 

commodities to Table 1 of this section. 

Compliance with the tolerance levels 

specified in Table 1 is to be determined 

by measuring only residues of 

fluxametamide, 4-[5-(3,5- 

dichlorophenyl)-4,5-dihydro-5- 

(trifluoromethyl)-3-isoxazolyl]-N- 

[(methoxyamino)methylene]-2- 

methylbenzamide in or on the 

commodities: 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Tea, dried ............................. 5 

Tea, instant ........................... 5 

(b)–(d) [Reserved] 

[FR Doc. 2021–03179 Filed 2–16–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0064; FRL–10018–70] 

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 tea commodities. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 17, 2021. Objections and 

requests for hearings must be received 

on or before April 19, 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–2020–0064, 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. Please review the 

visitor instructions and additional 

information about the docket available 

at http://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–2020–0064 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 


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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 9867 

received by the Hearing Clerk on or 

before April 19, 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– 

2020–0064, 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 April 15, 

2020 (85 FR 20910) (FRL–10006–54), 

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 9F8810) by 

Syngenta Crop Protection, LLC, 410 

Swing Road, Greensboro, NC 27409. The 

petition requested that 40 CFR 180.505 

be amended by establishing a tolerance 

for residues of the insecticide 

emamectin benzoate (a mixture of a 

minimum of 90% 4′-epi-methylamino4′-deoxyavermectin B1a and a 

maximum of 10% 4′-epi-methlyamino4′deoxyavermectin B1b benzoate), and 

its metabolites 8,9 isomer of the B1a and 

B1b in or on tea leaves at 0.2 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, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerances that vary from 

what is requested. The reason for these 

changes is explained in Unit IV.D. 

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 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 

benzoate including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with emamectin 

benzoate follows. 

In an effort to streamline Federal 

Register publications, EPA is not 

reprinting here summaries of its 

analysis that have previously appeared 

in the Federal Register in previous 

tolerance rulemakings for the same 

pesticide. To that end, this rulemaking 

refers the reader to several sections from 

the August 27, 2019 tolerance 

rulemaking for residues of emamectin 

benzoate that remain unchanged for an 

understanding of the Agency’s rationale 

in support of this rulemaking. See (84 

FR 44718) (FRL–9997–10). Those 

sections are: Units III.A (Toxicological 

Profile); III.B. (Toxicological Points of 

Departure/Levels of Concern); III.C. 

(Exposure Assessment), except as 

explained in the next paragraphs; III.D. 

(Safety Factor for Infants and Children); 

and IV.A (Analytical Enforcement 

Method). 

Exposure assessment updates. EPA’s 

exposure assessments have been 

updated to include the additional 

exposure from residues of emamectin 

benzoate in or on tea commodities. The 

assessments continue to be refined as 

described in the August 27, 2019 

tolerance rule preamble. The residues of 

emamectin benzoate on tea commodities 

is not being approved for domestic use, 

so no changes were made to EPA’s 

drinking water assessment or residential 

exposure assessment. 

Assessment of aggregate risks. 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 PODs to ensure that an 

adequate 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: 26% 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: 3.4% of the chronic 

population adjusted dose (cPAD) for 

children 1 to 2 years old, the group with 

the highest exposure. As there are no 

residential exposures expected, 

aggregate risks are equivalent to the 

dietary risks, which are below the 

Agency’s levels of concern. Based on the 

most recent screening-level cumulative 

exposure assessment, EPA has 

concluded the cumulative aggregate 

dietary and residential exposures for 

emamectin benzoate result in aggregate 

margins of exposures above the level of 

concern of 100 for all scenarios assessed 

and are not of concern. 

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 emamectin 

benzoate residues. More detailed 

information on the subject action to 

establish a tolerance in or on tea 

commodities can be found in the 

document entitled, ‘‘Emamectin 

(Emamectin Benzoate). Human Health 

Risk Assessment in Support of 

Establishing Tolerances without a U.S. 

Registration for Residues of Emamectin 

in/on Tea Commodities’’ by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, which 


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9868 Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 

is described under ADDRESSES. Locate 

and click on the hyperlink for docket ID 

number EPA–HQ–OPP–2020–0064. 

IV. Other Considerations 

A. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for emamectin benzoate. 

B. Revisions to Petitioned-For 

Tolerances 

The tolerance on tea commodities is 

being set at 0.5 ppm instead of the 

proposed level at 0.2 ppm in order to 

harmonize with the Japanese MRL. For 

the proposed tolerance on tea, the 

commodity definition was revised to 

include the standard commodities of 

‘‘tea, dried’’ and ‘‘tea, instant.’’ 

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 

tea, dried and tea, instant at 0.5 ppm. 

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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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: January 26, 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, amend paragraph 

(a)(1) by designating the table and 

adding in alphabetical order in newly 

designated table 1 to paragraph (a)(1) 

the entries ‘‘Tea, dried’’; and ‘‘Tea, 

instant’’ to read as follows: 

§ 180.505 Emamectin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

* * * * * 

Tea, dried 1 ................................. 0.5 

Tea, instant 1 ............................... 0.5 

* * * * * 

1Emamectin benzoate has not been registered for use in the United States as of February 17, 2021. 

* * * * * 

[FR Doc. 2021–03174 Filed 2–16–21; 8:45 am] 

BILLING CODE 6560–50–P 


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