9862 Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 

Dated: February 3, 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 § 180.431, amend paragraph (a) 

by designating the table and adding in 

alphabetical order in newly designated 

Table 1 to paragraph (a) the entries 

‘‘Caneberry subgroup 13–07A’’; ‘‘Onion, 

bulb, subgroup 3–07A’’; ‘‘Wheatgrass, 

intermediate, bran’’; ‘‘Wheatgrass, 

intermediate, forage’’; ‘‘Wheatgrass, 

intermediate, germ’’; ‘‘Wheatgrass, 

intermediate, grain’’; ‘‘Wheatgrass, 

intermediate, middling’’; ‘‘Wheatgrass, 

intermediate, shorts’’; and ‘‘Wheatgrass, 

intermediate, straw’’ to read as follows: 

§ 180.431 Clopyralid; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Caneberry subgroup 13–07A ..... 0.1 

* * * * * 

Onion, bulb, subgroup 3–07A .... 0.4 

* * * * * 

Wheatgrass, intermediate, bran 12 

* * * * * 

Wheatgrass, intermediate, forage 9 

* * * * * 

Wheatgrass, intermediate, germ 12 

* * * * * 

Wheatgrass, intermediate, grain 3 

* * * * * 

Wheatgrass, intermediate, middling ......................................... 12 

* * * * * 

Wheatgrass, intermediate, shorts 12 

* * * * * 

Wheatgrass, intermediate, straw 9 

* * * * * 

[FR Doc. 2021–03172 Filed 2–16–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0492; FRL–10018–86] 

Fluxametamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluxametamide 

in or on tea, dried and tea, instant. 

Nissan Chemical Corporation 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–2019–0492, 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 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–2019–0492 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 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– 

2019–0492, 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. 


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• 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 February 

11, 2020 (85 FR 7708) (FRL–10005–02), 

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 9E8757) by Nissan 

Chemical Corporation, 5–1, Nihonbashi 

2-Chome Chuo-Ku, Tokyo 101–6119

Japan, c/o Lewis and Harrison, 2461

South Clark Street, Suite 710, Arlington,

VA 22202. The petition requested that

40 CFR part 180 be amended by

establishing tolerances for residues of

the insecticide fluxametamide,

including its metabolites and

degradates, in or on tea at 5 parts per

million (ppm). That document

referenced a summary of the petition

prepared by Nissan Chemical

Corporation c/o Lewis and Harrison, 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 has revised 

the commodity definition and is 

establishing a tolerance for tea, dried 

and tea, instant. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and

Determination of Safety

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluxametamide 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. 

Fluxametamide belongs to a class of 

compounds called isoxazolines, which 

are potent inhibitors of g-aminobutyric 

acid (GABA)-, glutamate-, and glycinegated chloride channels in insects. 

However, this pesticidal mode of action 

(MOA) does not seem to be operative in 

mammals as neurotoxicity was not 

found in either the acute or subchronic 

neurotoxicity studies at the limit dose. 

The available studies show different 

organs can be affected. For the dietary 

toxicity studies in rats (neurotoxicity 

study, chronic/carcinogenicity, and 

reproductive toxicity studies), a 

common effect on the gastrointestinal 

(GI) tract was observed. The effects 

consisted of gross pathology (an 

increase incidence of abnormally pale 

color duodenum and jejunum) and 

histopathology (increased incidence of 

enterocyte epithelial vacuolation of the 

jejunum). Most of the effects seen in the 

subchronic neurotoxicity study were 

reproduced in the combined chronic 

and carcinogenicity study with 

increased severity and at lower dose 

level. In addition, consistent adverse 

effects were found in the lung (aggregate 

alveolar marcophages and cholesterol 

cleft) and liver (centrilobular 

hepatocellular vacuolation and 

periportal hepatocellular vacuolation). 

These adverse effects were present at a 

dose as low as 9 mg/kg/day in the 

carcinogenicity study. 

Fluxametamide is classified as having 

‘‘suggestive evidence of carcinogenic 

potential’’ based on thyroid tumors in 

male rats and liver tumors in male mice. 

The reasons for this classification are (1) 

both tumor types are driven by 

adenomas, (2) these increased tumor 

incidences are seen at the highest doses 

tested (877 mg/kg/day for male mice 

and 899 mg/kg/day for male rats); these 

doses are approaching the limit dose 

(1000 mg/kg/day) for a carcinogenicity 

study, (3) there is no hyperplasia of the 

liver in either male or female mice, (4) 

no increase in treatment-related tumors 

has been observed in female mice or 

female rats, and (5) no genotoxicity is 

observed in the required battery of 

mutagenic studies. Due to the lack of 

genotoxicity and the fact that the tumors 

are seen only at doses more than 100- 

fold above the chronic reference dose, 

EPA has determined that a non-linear 

approach relying on the chronic 

reference dose (RfD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to fluxametamide. 

The in-utero and perinatal treatment 

with fluxametamide in rats resulted in 

toxicity and increased quantitative 

susceptibility in developing animals. In 

the 2-generation reproduction study, 

fluxametamide produced no parental 

effect at the highest dose tested (19 mg/ 

kg/day), while at the same dose level 

produced offspring effect which 

consisted of the observation that the 

pups had distended abdomens and 

affected pups had to be sacrificed for 

humane reason. The dermal toxicity 

study did not show systemic toxicity at 

the limit dose (1000 mg/kg/day). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluxametamide, as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies, can be found at http:/ 

www.regulations.gov in document titled 

‘‘Fluxametamide: Human Health Risk 

Assessment to Support the 

Establishment of a Tolerance without 

U.S. Registration in/on Tea. First Food 

Use’’ hereinafter ‘‘Fluxametamide 

Human Health Risk Assessment’’ at 

pages 16–22 in docket ID number EPA– 

HQ–OPP–2019–0492. 

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 


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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 fluxametamide used for 

human risk assessment can be found in 

the Fluxametamide Human Health Risk 

Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluxametamide, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from fluxametamide 

in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for fluxametamide; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the United States Department 

of Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/ 

WWEIA). As to residue levels in food, 

EPA assumed tolerance-level residues of 

fluxametamide on tea and 100% crop 

treated. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach will adequately account for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to fluxametimide. A separate 

cancer dietary exposure and risk 

assessment is not required. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii., 

chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for fluxametamide. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. EPA assumes that there is no 

exposure through drinking water 

because fluxametamide is not registered 

for use in the United States. Because 

residues are not expected in drinking 

water, dietary risk estimates include 

exposures from food only. 

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). 

Fluxametamide is not being proposed to 

be registered for any specific use 

patterns that would result in residential 

exposure. 

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 

fluxametamide and any other 

substances and fluxametamide does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this action, therefore, EPA 

has not assumed that fluxametamide 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. 

There is an increase in quantitative 

susceptibility in two-generation 

reproductive toxicity study in rats. In 

this study, parental animals showed no 

adverse effects at 19 mg/kg/day (highest 

dose tested, HDT), whereas some pups 

had to be euthanized due to distended 

abdomen at the same dose. However, 

the concern is low because there was a 

clear NOAEL for the offspring effect (6 

mg/kg/day) and the POD selected for 

chronic dietary exposure assessment (1 

mg/kg/day) is protective of the offspring 

effects seen in the reproductive toxicity 

study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluxametamide is complete. 

ii. There is no indication that 

fluxametamide is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is evidence of an increase in 

quantitative susceptibility in the 2- 

generation reproductive toxicity study 

in rats. In this study, parental animals 

showed no adverse effects at 19 mg/kg/ 

day highest dose tested, (HDT), whereas 

some pups had to be euthanized due to 

distended abdomen at the same dose. 

However, the concern is low because 

there was a clear NOAEL for the 

offspring effect (6 mg/kg/day) and the 

POD selected for chronic dietary 

exposure assessment (1 mg/kg/day) is 

protective of the offspring effects seen in 

the reproductive toxicity study. The 

selected points of departure for risk 

assessment are protective of the 

quantitative increase in susceptibility 

seen in the rat reproductive toxicity 

study, for which a clear NOAEL and 

LOAEL are established. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. These 


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assessments will not underestimate the 

exposure and risks posed by 

fluxametamide. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fluxametamide is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluxametamide 

from food only will utilize less than 1% 

of the cPAD for all population 

subgroups. There are no residential uses 

for fluxametamide. 

3. Short-and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because fluxametamide 

is not registered in the United States, 

the only exposures will be dietary, from 

residues in or on imported tea; 

therefore, no short-term or intermediateterm residential exposure is expected. 

Because there is no short- or 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for fluxametamide. 

4. Aggregate cancer risk for U.S. 

population. As stated in Unit III.A., EPA 

has concluded that the chronic 

reference dose (RfD) will adequately 

account for all repeated exposure/ 

chronic toxicity, including 

carcinogenicity, which could result 

from exposure to fluxametamide. Based 

on the lack of chronic risk at regulated 

levels of exposure, EPA concludes that 

exposure to fluxametamide will not 

pose an aggregate cancer risk. 

5. 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 

fluxametamide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/ 

MS), Method NCI–2012–101/NCI–2013– 

017) is available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established an 

MRL for fluxametamide. 

C. Revisions to Petitioned-For 

Tolerances 

The petition requested a tolerance for 

residues of fluxametamide in or on tea. 

Since dried tea is the commodity that 

enters commerce, EPA is establishing 

the tolerance for the processed 

commodity tea, dried rather than tea, 

plucked leaves. EPA is also establishing 

a tolerance for tea, instant, which is 

another processed commodity of tea, 

plucked leaves, and EPA has 

determined that the same tolerance of 5 

ppm is appropriate for instant tea. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluxametamide, 

including its metabolites and 

degradates, in or on tea, dried at 5 ppm 

and tea, instant at 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 


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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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