40338 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Rules and Regulations 

Dated: July 16, 2021. 

Deborah Jordan, 

Acting Regional Administrator, Region IX. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency amends part 52, chapter I, title 

40 of the Code of Federal Regulations as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c)(423)(i)(A)(8), (9), 

and (10), (c)(527)(i)(C), and (c)(545)(i)(C) 

to read as follows: 

§ 52.220 Identification of plan-in part. 

* * * * * 

(c) * * * 

(423) * * * 

(i) * * * 

(A) * * * 

(8) Previously approved on January 

31, 2013, in paragraph (c)(423)(i)(A)(1) 

of this section and now deleted with 

replacement in paragraph 

(c)(527)(i)(C)(1) of this section, Rule 301 

‘‘Nonagricultural Burning Smoke 

Management’’, amended on February 9, 

2012. 

(9) Previously approved on January 

31, 2013, in paragraph (c)(423)(i)(A)(2) 

of this section and now deleted with 

replacement in paragraph 

(c)(527)(i)(C)(2) of this section, Rule 302 

‘‘Agricultural Waste Burning Smoke 

Management’’, amended on February 9, 

2012. 

(10) Previously approved on January 

31, 2013, in paragraph (c)(423)(i)(A)(5) 

of this section and now deleted with 

replacement in paragraph 

(c)(545)(i)(C)(1) of this section, Rule 305 

‘‘Residential Allowable Burning’’, 

amended on February 9, 2012. 

* * * * * 

(527) * * * 

(i) * * * 

(C) Placer County Air Pollution 

Control District. 

(1) Rule 301, ‘‘Nonagricultural 

Burning Smoke Management,’’ amended 

on August 9, 2018. 

(2) Rule 302, ‘‘Agricultural Waste 

Burning Smoke Management’’ amended 

on August 9, 2018. 

* * * * * 

(545) * * * 

(i) * * * 

(C) Placer County Air Pollution 

Control District, 

(1) Rule 305, ‘‘Residential Allowable 

Burning’’ amended on October 11, 2018. 

(2) [Reserved] 

* * * * * 

[FR Doc. 2021–16009 Filed 7–27–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0334; FRL–8656–01– 

OCSPP] 

Fludioxonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of fludioxonil in 

or on banana. Syngenta Crop Protection, 

LLC requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

28, 2021. Objections and requests for 

hearings must be received on or before 

September 27, 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–2020–0334, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

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

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(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–2020–0334 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 

September 27, 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– 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Rules and Regulations 40339 

2020–0334, 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 22, 

2021 (86 FR 21317) (FRL–10022–59), 

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 9E8798) by 

Syngenta Crop Protection, LLC, 410 

Swing Road, NC 27419–8300. The 

petition requested that 40 CFR 180.516 

be amended by establishing a tolerance 

for residues of the fungicide fludioxonil, 

4-(2,2-difluoro-1,3-benzodioxol-4-yl)- 

1H-pyrrole-3-carbonitrile, in or on 

banana at 2.0 parts per million (ppm). 

That document referenced a summary of 

the petition prepared by Syngenta Crop 

Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 is 

modifying the requested tolerance based 

on crop field trial data and for 

consistency with the Organization for 

Economic Co-Operation and 

Development (OECD) tolerancerounding class practice. The reason for 

these changes are 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 

therein, 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 fludioxonil, 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with fludioxonil follows. 

In an effort to streamline Federal 

Register publications, EPA is not 

reprinting here summaries of its 

analyses 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 November 6, 2018 tolerance 

rulemaking for residues of fludioxonil 

that remain unchanged for an 

understanding of the Agency’s rationale 

in support of this rulemaking. See 83 FR 

55491 (FRL–9982–75). 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; and III.D. (Safety 

Factor for Infants and Children). Further 

information about the Agency’s risk 

assessment and determination of safety 

supporting the new tolerance for 

residues of fludioxonil on bananas can 

be found in docket ID number EPA– 

HQ–OPP–2020–0334 in the document 

titled ‘‘Fludioxonil. Human Health Risk 

Assessment for the Establishment of a 

Permanent Tolerance on Imported 

Bananas.’’ 

Updates to exposure assessments. 

EPA’s dietary (food and drinking water) 

exposure assessments have been 

updated to include the additional 

exposure from use of fludioxonil on 

bananas, and relied on tolerance-level 

residues, an assumption of 100 percent 

crop treated (PCT), and 2018 default 

processing factors for all processed 

commodities. EPA’s aggregate exposure 

assessment incorporated this additional 

dietary exposure. Drinking water 

exposures are not impacted by the new 

use on banana, and thus have not 

changed since the last assessment. 

Assessment of aggregate risks. An 

acute aggregate risk assessment was not 

conducted since effects attributable to a 

single exposure were not identified. 

Short-term aggregate risk for adults and 

children resulted in margins of exposure 

≥ 280, which is above the level of 

concern of 100 and not of concern. An 

intermediate-term aggregate risk 

assessment was not conducted since 

exposures are not expected based on the 

use pattern. The chronic aggregate risk 

assessment was equivalent to the 

chronic dietary risk assessment and was 

not conducted since there are no longterm exposures expected based on the 

use pattern. Chronic aggregate risks 

consist of dietary (food and drinking 

water) exposure only and are below the 

Agency’s level of concern: 56% of the 

chronic population adjusted dose 

(cPAD) for children 1 to 2 years old, the 

group with the highest exposure. 

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 fludioxonil 

residues. More detailed information on 

the subject action to establish a 

tolerance in or on bananas can be found 

in the document entitled, ‘‘Fludioxonil. 

Human Health Risk Assessment for the 

Establishment of a Permanent Tolerance 

on Imported Bananas’’ by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, EPA– 

HQ–OPP–2020–0334. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography/ultraviolet (HPLC/UV) 

methods (Methods AG–597 and AG– 

597B)) is available for enforcing 

tolerances for fludioxonil on plant 

commodities. An adequate liquid 

chromatography, tandem mass 

spectrometry (LC–MS/MS) method 

(Analytical Method GRM025.03A) is 

available for enforcing tolerances for 

fludioxonil on livestock commodities. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 


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40340 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Rules and Regulations 

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 a MRL 

for fludioxonil; however, Canada’s Pest 

Management Regulatory Agency 

(PMRA) has a default MRL of 0.1 ppm 

on banana. EPA is establishing a 

tolerance level for bananas at 3 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioned-for tolerance level of 

2.0 ppm in bananas has been modified 

to 3 ppm based on crop field trial data 

and the OECD tolerance calculation 

procedure. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of fludioxonil, 4-(2,2- 

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or on banana 

at 3 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

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

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

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

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 15, 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 § 180.516, amend table 1 to 

paragraph (a)(1) by adding in 

alphabetical order the entry ‘‘Banana’’ 

and footnote 1 to read as follows: 

§ 180.516 Fludioxonil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

*****

Banana1 ...................................... 3 

*****

1There are no U.S. registrations as of July 

28, 2021. 

* * * * * 

[FR Doc. 2021–16091 Filed 7–27–21; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket No. 12–375, FCC 21–60; FRS 

35682] 

Rates for Interstate Inmate Calling 

Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; denial of 

reconsideration. 


khammond on DSKJM1Z7X2PROD with RULES