29694 Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations 

designated representative on VHF–FM 

channel 16 or by telephone at 508–457– 

3211. 

(3) Persons and vessels permitted to 

enter this regulated area must transit at 

their slowest safe speed and comply 

with all lawful directions issued by the 

COTP or the designated representative. 

(d) Informational broadcasts. The 

COTP or a designated representative 

will inform the public through local 

notice to mariners and Broadcast 

Notices to Mariners of the enforcement 

period for the regulated area as well as 

any changes in the planned schedule. 

Dated: April 14, 2021. 

C.J. Glander, 

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

Port Sector Southeastern New England. 

[FR Doc. 2021–11689 Filed 6–2–21; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0626; EPA–HQ–OPP– 

2020–0082; and EPA–HQ–OPP–2020–0345; 

FRL–10022–28] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on olive; olive, 

with pit; pepper, black; and persimmon, 

Japanese. Syngenta Crop Protection, 

LLC. and the American Spice Trade 

Association, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

3, 2021. Objections and requests for 

hearings must be received on or before 

August 2, 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 dockets for these 

actions, identified by docket 

identification (ID) numbers EPA–HQ– 

OPP–2019–0626, EPA–HQ–OPP–2020– 

0082, and EPA–HQ–OPP–2020–0345, 

are 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(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2019–0626, EPA–HQ–OPP–2020– 

0082, and/or EPA–HQ–OPP–2020–0345 

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 August 2, 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– 

2019–0626, EPA–HQ–OPP–2020–0082, 

and/or EPA–HQ–OPP–2020–0345, 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 February 

10, 2020 (85 FR 7499) (FRL–10004–54) 

and May 29, 2020 (85 FR 32338) (FRL– 

10009–84), EPA issued documents 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of pesticide petitions (PP 9E8793 and PP 

9E8814) by Syngenta Crop Protection, 

LLC, P.O. Box 18300, Greensboro, NC 

27419–8300. In the Federal Register of 

September 10, 2020 (85 FR 55810) 

(FRL–10013–78), EPA issued documents 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP 0E8834) by 

the American Spice Trade Association, 

Inc., 1101 17th St. NW, Suite 700, 

Washington, DC 20036. The petitions 

requested that 40 CFR 180.475 be 


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amended by establishing tolerances for 

residues of the fungicide 

difenoconazole, in or on persimmon, 

Japanese at 0.7 parts per million (ppm) 

(9E8793); olive (including oil) at 2 ppm 

(9E8814); and pepper, black at 0.1 ppm 

(0E8834). Those documents referenced 

summaries of the petitions prepared by 

Syngenta Crop Protection, LLC, and the 

American Spice Trade Association, Inc., 

the petitioners, which are available in 

the dockets for these actions, EPA–HQ– 

OPP–2019–0626, EPA–HQ–OPP–2020– 

0082, and EPA–HQ–OPP–2020–0345 at 

http://www.regulations.gov. Two 

comments were received related to the 

import tolerance on black pepper. EPA’s 

responses to these comments are 

discussed in Unit IV.B. 

FFDCA section 408(d)(4)(A)(i) permits 

the Agency to finalize a tolerance that 

varies from that sought by the petition. 

Based upon review of the data 

supporting the petition, EPA has 

corrected the commodity definition of 

‘‘olive (including oil)’’ to ‘‘olive’’ and 

‘‘olive, with pit’’, and the tolerance level 

set with ‘‘olive’’ varies from that sought 

by the petition. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

A. Statutory Background 

Section 408(b)(2)(A)(i) of the 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 it 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), 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 difenoconazole and to 

make a determination on aggregate 

exposure for difenoconazole, including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with difenoconazole follows. 

B. Difenoconazole Aggregate Risk 

Assessment 

Information on aggregate risk from 

difenoconazole is found in the 

‘‘Difenoconazole. Human Health Risk 

Assessment for the Establishment of 

Tolerances with No U.S. Registrations 

in/on Japanese Persimmon, Olive, and 

Black Pepper’’ in docket ID numbers 

EPA–HQ–OPP–2019–0626, EPA–HQ– 

OPP–2020–0082, and EPA–HQ–OPP– 

2020–0345. 

C. 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. 

The liver is the target organ in mice 

and rats; however, effects occur in mice 

at lower doses and with higher severity 

than in rats. Furthermore, 

difenoconazole is classified as 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ based on liver tumors 

(adenomas) in male and female mice. 

Apart from the liver effects in rodents, 

chronic exposure in dogs leads to 

lenticular cataracts. 

In dermal studies, no systemic 

toxicity was detected in rats or male 

rabbits, while in female rabbits, liver 

effects occurred at the limit dose. Skin 

hyperkeratosis was detected in rats at 

the exposure site after repeated 

exposure to the limit dose. Slight skin 

irritation was detected after an acute 

single dose (Toxicity Category IV). 

Difenoconazole is not a skin sensitizer. 

No quantitative susceptibility in fetus 

or offspring was seen in the database. 

Neurotoxicity was detected in an acute 

neurotoxicity battery study (decreased 

fore-limb strength in males only), but 

not in a subchronic neurotoxicity 

battery study with difenoconazole. 

In an immunotoxicity study in mice, 

decreased mean immunoglobin M levels 

were detected at dose levels ≥ 177 mg/ 

kg/day. There is no other indication of 

immunotoxicity in the difenoconazole 

database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by difenoconazole as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Difenoconazole. Human Health Risk 

Assessment for the Establishment of 

Tolerances with No U.S. Registrations 

in/on Japanese Persimmon, Olive, and 

Black Pepper.’’ at page 20 in docket ID 

numbers EPA–HQ–OPP–2019–0626, 

EPA–HQ–OPP–2020–0082, and EPA– 

HQ–OPP–2020–0345. 

D. 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://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. A summary of the 

toxicological endpoints for 

difenoconazole used for the human 

health risk assessment is shown in the 

risk assessment posted to the dockets. 

E. Exposure Assessment 

EPA’s chronic dietary (food and 

drinking water) exposure assessments 

have been updated to include the 

additional exposure from the import 

tolerances of difenoconazole on olive; 

olive, with pit; pepper, black; and 

persimmon, Japanese. The exposure 

assessment used tolerance-level 

residues and default processing factors 

for all processed commodities. The 

percent crop treated numbers used for 

the chronic dietary assessment vary 

from what was used in the previous 

assessment and are available in the 

human health risk assessment posted to 

the dockets. 


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Drinking water exposures are not 

impacted by the import tolerances on 

olive; olive, with pit; pepper, black; and 

persimmon, Japanese. The estimated 

drinking water concentrations (EDWCs) 

of total toxic residues (TTR) of 

difenoconazole can be found in the 

human health risk assessment. 

Acute dietary (food and drinking 

water) risks are below the Agency’s 

level of concern of 100% of the acute 

population adjusted dose (aPAD): They 

are 53% of the aPAD for all infants less 

than 1-year old, the population 

subgroup with the highest exposure 

estimate. Chronic dietary risks are 

below the Agency’s level of concern of 

100% of the chronic population 

adjusted dose (cPAD): They are 38% of 

the cPAD for all infants less than 1-year 

old, the population subgroup with the 

highest exposure estimate. 

For the aggregate risk assessment, 

exposures to difenoconazole in food and 

drinking water are combined with 

residential exposures for the relevant 

exposure duration period. Because 

acute, intermediate-term, or long-term 

residential exposures are not expected, 

aggregate acute and chronic risk is 

equivalent to the dietary risks, which 

are below EPA’s level of concern. 

Moreover, a separate cancer dietary risk 

assessment was not required since the 

approach used for chronic dietary 

exposure assessment was found to be 

adequately protective of all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

difenoconazole. Short-term aggregate 

risk, which combines chronic dietary 

exposure with the expected residential 

handler inhalation exposures from 

applications to gardens/ornamentals via 

hose-end sprayer, yields a margin of 

exposure (MOE) of 5,000, which is not 

of concern because it exceeds EPA’s 

level of concern (MOEs less than or 

equal to 100). Previously the residential 

exposure assessments for 

difenoconazole included a dermal 

endpoint; however, that endpoint is no 

longer relevant because the database 

does not show systemic effects after 

exposure via the dermal route at doses 

that would be relevant to risk 

assessment. 

F. 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 

difenoconazole and any other 

substances, although EPA has 

previously concluded that there are no 

conclusive data that difenoconazole 

shares a common mechanism of toxicity 

with other conazole pesticides. 

Although the conazole fungicides 

(triazoles) produce 1,2,4 triazole and its 

acid-conjugated metabolites 

(triazolylalanine and triazolylacetic 

acid), 1,2,4 triazole and its acidconjugated metabolites do not 

contribute to the toxicity of the parent 

conazole fungicides (triazoles). A 

separate aggregate risk assessment was 

conducted for 1,2,4 triazole and the 

conjugated triazole metabolites 

‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address the 

Establishment of a Difenoconazole 

Tolerances with No U.S. Registration for 

Imported Olive and Black Pepper and to 

include updated Estimated Drinking 

Water Concentrations; DP458929’’, 

dated September, 14, 2020 and it can be 

found at https://www.regulations.gov at 

docket ID numbers EPA–HQ–OPP– 

2019–0626, EPA–HQ–OPP–2020–0082, 

and EPA–HQ–OPP–2020–0345. These 

new tolerances of difenoconazole 

considered with existing uses of triazole 

compounds do not result in a risk of 

concern for 1,2,4-triazole and the 

conjugated metabolites. Difenoconazole 

does not appear to produce any other 

toxic metabolite produced by other 

substances. For the purposes of this 

action, therefore, EPA has not assumed 

that difenoconazole has a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

G. Safety Factor for Infants and 

Children 

There were no changes since the last 

risk assessment regarding prenatal and 

postnatal sensitivity. The FQPA Safety 

Factor (SF) is still reduced to 1X; 

however, the safety factor reduction 

rationale section has been modified to: 

i. The toxicity database for 

difenoconazole is sufficient for a full 

hazard evaluation and is considered 

adequate to evaluate risks to infants and 

children. 

ii. The only study that showed 

neurotoxicity is used as the point of 

departure for risk assessment and the 

effect is well characterized with a clear 

NOAEL and LOAEL. There are signs of 

neurotoxicity in the acute neurotoxicity 

battery study (decreased fore-limb 

strength in males), but not in the 

subchronic neurotoxicity battery study, 

nor in any other studies in the database. 

This risk assessment is protective of the 

observed neurotoxicity effects because 

they are used to establish the point of 

departure (POD) for the acute oral 

assessment. 

iii. There is no evidence that 

difenoconazole results in increased 

quantitative susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

No fetal effects were detected in rats. 

Fetal effects in rabbits and pup effects 

in rats occurred at the same doses as 

maternal effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on tolerance-level 

residues and 100% CT for the acute 

assessment while the chronic 

assessment assumed tolerance-level 

residues, the available empirical or 

HED’s 2018 Default Processing Factors, 

and average percent crop treated (PCT) 

information for some commodities. 

These assumptions will not 

underestimate dietary exposure to 

difenoconazole. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to difenoconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children. These 

assessments will not underestimate the 

exposure and risks posed by 

difenoconazole. 

H. Determination of Safety 

Therefore, based on the risk 

assessments and information described 

above, 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 difenoconazole residues. 

More detailed information about the 

Agency’s analysis can be found in 

‘‘Difenoconazole. Human Health Risk 

Assessment for the Establishment of 

Tolerances with No U.S. Registrations 

in/on Japanese Persimmon, Olive, and 

Black Pepper.’’ dated March 23, 2021 in 

docket ID numbers EPA–HQ–OPP– 

2019–0626, EPA–HQ–OPP–2020–0082, 

and EPA–HQ–OPP–2020–0345. 


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IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate tolerance enforcement 

method, gas chromatography with 

nitrogen-phosphorus detection (GC/ 

NPD) method AG–575B, is available for 

the determination of residues of 

difenoconazole in/on plant 

commodities. An adequate enforcement 

method, gas chromatography with mass 

spectrometry detection (GC/MSD) 

method AG–676A, is also available for 

the determination of residues of 

difenoconazole per se in/on canola and 

barley commodities. A confirmatory 

method, GC/MSD method AG–676, is 

also available. 

An adequate tolerance enforcement 

method, Method REM 147.07b, is 

available for livestock commodities. The 

method determines residues of 

difenoconazole and CGA–205375 in 

livestock commodities by liquid 

chromatography with tandem mass 

spectrometry detection (LC–MS/MS). 

Adequate confirmatory methods, 

Method AG–544A and Method REM 

147.06, are available for the 

determination of residues of 

difenoconazole and CGA–205375, 

respectively, in livestock commodities. 

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). 

Codex has established MRLs for 

residues of difenoconazole in/on olive 

commodities using the same data 

submitted in support of the U.S. 

tolerances with no U.S. registrations. 

Codex stipulates that residues should be 

expressed on a whole-fruit basis. The 

U.S. recommended tolerance level for 

olive, with pit (2 ppm) is harmonized 

with the Codex MRL for residues of 

difenoconazole in/on table olives (2 

ppm). In addition, a tolerance is being 

set at 3 ppm on olive, defined in OCSPP 

Guideline 860.1000 as fruits after 

removal of the stems and pits, which is 

the commodity analyzed for 

enforcement. 

Codex has not established MRLs for 

residues of difenoconazole in/on 

pepper, black. MRLs for of 

difenoconazole in/on peppercorn (black, 

green and white) at 0.3 ppm have been 

established in the European Union (EU). 

Discussion on why EPA did not 

harmonize with that tolerance is 

covered in the Responses to Comments 

section in Unit IV.B. 

A Codex MRL for difenoconazole has 

been established at 4 ppm in/on pome 

fruit for post-harvest use. Codex 

includes Japanese persimmon in the 

pome fruit group. The tolerance being 

set at this time is based on late-season 

foliar use rather than post-harvest use; 

therefore, the tolerances are not the 

same and harmonization is not possible. 

C. Responses to Comments 

EPA received one comment on the 

docket for difenoconazole in/on black 

pepper (EPA–HQ–OPP–2020–0345) 

opposing pesticide residues in food, 

although no substantive information 

was provided for EPA to take into 

consideration in its safety assessment. 

The commenter generally expressed 

concern about the potential for exposure 

to difenoconazole to be carcinogenic. 

EPA has evaluated the available data on 

carcinogenicity and exposure and 

determined that aggregate exposure to 

difenoconazole will not cause a cancer 

risk. In addition, the commenter 

expressed concern about fluoride in 

chemicals; however, difenoconazole 

molecules do not contain any fluoride. 

The FFDCA authorizes EPA to establish 

tolerances that permit certain levels of 

pesticide residues in or on food when 

the Agency can determine that such 

residues are safe. EPA has made that 

determination for the tolerances subject 

to this action, and the commenter 

provided no information relevant to that 

conclusion. 

A comment from the government of 

the People’s Republic of China (P.R. 

China) was received through the World 

Trade Organization comment process. 

This comment has been posted to the 

docket for difenoconazole in/on black 

pepper (EPA–HQ–OPP–2020–0345). It 

requests that EPA set the tolerance on 

pepper, black at 0.3 ppm to match the 

current EU tolerance. EPA consulted 

with the registrant regarding the 

possibility to harmonize the tolerance 

with the EU limit standards. The 

registrant, through its consultant, 

recommended against harmonizing the 

tolerance with the current EU MRL for 

residues of difenoconazole in/on black 

pepper (0.3 ppm) based on the following 

rationale. According to the registrant, 

the current EU MRL is not based on 

supporting data and is of unknown 

origin. It is expected that any EU MRL 

not supported by data, such as in this 

case, would be evaluated during the 

Article 12 EU MRL Review Process. If 

no supporting data are submitted during 

the review process, the EU MRL would 

be reduced to 0.01 ppm by 2026. The 

Agency notes that it is also possible that 

the same data that support the tolerance 

with no U.S. registration established in 

this action (0.1 ppm) could be submitted 

as supporting data to the EU and/or 

Codex, in which case future 

harmonization is possible. In addition, 

the P.R. China comment requests that 

EPA share the data and reports 

supporting the tolerance. More detailed 

information about the Agency’s analysis 

can be found in the risk assessments 

posted to docket ID number EPA–HQ– 

OPP–2020–0345. 

D. Revisions to Petitioned-For 

Tolerances 

Although the summary of the petition 

cited in Unit II of this preamble 

indicated a request for a tolerance on 

‘‘olive,’’ the actual petition sought a 

tolerance for ‘‘olive (including oil).’’ The 

originally requested tolerance of 2 ppm 

in/on ‘‘olive (including oil)’’ has been 

revised to 2 ppm in/on ‘‘olive, with pit’’ 

and 3 ppm in/on ‘‘olive.’’ The 

commodity definition commonly used 

in the 40 CFR is ‘‘olive,’’ meaning fruits 

after removal of the pits, and the 

terminology ‘‘olive, with pit’’ is 

descriptive of the Codex residue 

expression. Use of both terms allows 

harmonization with Codex while also 

maintaining the way that the 

commodity is analyzed for enforcement 

in the United States. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, in or on 

olive at 3 ppm; olive, with pit at 2 ppm; 

pepper, black at 0.1 ppm; and 

persimmon, Japanese at 0.7 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 


khammond on DSKJM1Z7X2PROD with RULES
29698 Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations 

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: May 20, 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 § 180.475, amend paragraph 

(a)(1) by adding alphabetically to the 

table entries for ‘‘Olive 1’’; ‘‘Olive, with 

pit 1’’; ‘‘Pepper, black 1’’ and 

‘‘Persimmon, Japanese 1’’ to read as 

follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

****

Olive 1 .......................................... 3 

Olive, with pit 1 ............................ 2 

 

Pepper, black 1 ............................ 0.1 

Persimmon, Japanese 1 .............. 0.7 

** **

1There are no U.S. registrations for these 

commodities. 

* * * * * 

[FR Doc. 2021–11636 Filed 6–2–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 372 

[EPA–HQ–TRI–2021–0049; FRL–10022–25] 

RIN 2070–AK72 

Implementing Statutory Addition of 

Certain Per- and Polyfluoroalkyl 

Substances (PFAS) to the Toxics 

Release Inventory Beginning With 

Reporting Year 2021 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is adding three per- and 

polyfluoroalkyl substances (PFAS) to 

the list of chemicals subject to toxic 

chemical release reporting under the 

Emergency Planning and Community 

Right-to-Know Act (EPCRA) and the 

Pollution Prevention Act (PPA). This 

action implements the statutory 

mandate in the National Defense 

Authorization Act for Fiscal Year 2020 

(FY2020 NDAA) enacted on December 

20, 2019. As this action is being taken 

to conform the regulations to a 

Congressional legislative mandate, 

notice and comment rulemaking is 

unnecessary. 

DATES: This final rule is effective July 6, 

2021. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–TRI–2021–0049, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC. 

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 OPPT 

Docket is (202) 566–0280. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

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: For 

technical information contact: Daniel R. 


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