Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations 34145 

Dated: June 21, 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 § 180.1384 to subpart D to read 

as follows: 

§ 180.1384 Bacillus subtilis strain RTI477; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus subtilis strain RTI477 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2021–13804 Filed 6–28–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0475; FRL–10025–21] 

Bacillus velezensis Strain RTI301; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Bacillus 

velezensis strain RTI301 in or on all 

food commodities when used in 

accordance with label directions and 

good agricultural practices. FMC 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

velezensis strain RTI301 under FFDCA 

when used in accordance with this 

exemption. 

DATES: This regulation is effective June 

29, 2021. Objections and requests for 

hearings must be received on or before 

August 30, 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–2019–0475, 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: 

Charles Smith, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@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 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR 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–2019–0475 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 30, 2021. Addresses for mail and 

hand delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b), although EPA strongly 

encourages those interested in 

submitting objections or a hearing 

request, to submit objections and 

hearing requests electronically. See 

Order Urging Electronic Service and 

Filing (April 10, 2020), https://

www.epa.gov/sites/production/files/ 

2020-05/documents/2020-04-10_-_

order_urging_electronic_service_and_

filing.pdf. At this time, because of the 

COVID–19 pandemic, the judges and 

staff of the Office of Administrative Law 

Judges are working remotely and not 

able to accept filings or correspondence 

by courier, personal delivery, or 

commercial delivery, and the ability to 

receive filings or correspondence by 

U.S. Mail is similarly limited. When 

submitting documents to the U.S. EPA 

Office of Administrative Law Judges 

(OALJ), a person should utilize the 

OALJ e-filing system, at https://

yosemite.epa.gov/OA/EAB/EAB-ALJ_

upload.nsf. 

Although EPA’s regulations require 

submission via U.S. Mail or hand 

delivery, EPA intends to treat 

submissions filed via electronic means 

as properly filed submissions during 

this time that the Agency continues to 

maximize telework due to the 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 

impossible for a person to submit 

documents electronically or receive 

service electronically, e.g., the person 

does not have any access to a computer, 

the person shall so advise OALJ by 

contacting the Hearing Clerk at (202) 

564–6281. If a person is without access 

to a computer and must file documents 

by U.S. Mail, the person shall notify the 

Hearing Clerk every time it files a 

document in such a manner. The 


lotter on DSK11XQN23PROD with RULES1
34146 Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations 

address for mailing documents is U.S. 

Environmental Protection Agency, 

Office of Administrative Law Judges, 

Mail Code 1900R, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460. 

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– 

2019–0475, 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. Background 

In the Federal Register of February 4, 

2020 (85 FR 6129) (FRL–10003–17), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance exemption petition (PP 

9F8750) by FMC Corporation, 2929 

Walnut St., Philadelphia, PA 19104. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the fungicide 

Bacillus velezensis strain RTI301 in or 

on all food commodities. That notice 

referenced a summary of the petition 

prepared by the petitioner FMC 

Corporation and available in the docket 

via http://www.regulations.gov. 

Although one comment was submitted 

to the docket for this notice of filing, it 

was unrelated to this tolerance 

exemption rulemaking. 

III. Final Rule 

A. EPA’s Safety Determination 

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

allows EPA to establish an exemption 

from the requirement of a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance or tolerance exemption 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 . . . .’’ Additionally, FFDCA 

section 408(b)(2)(D) requires that EPA 

consider ‘‘available information 

concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and 

other substances that have a common 

mechanism of toxicity.’’ 

EPA evaluated the available 

toxicological and exposure data on 

Bacillus velezensis strain RTI301 and 

considered their validity, completeness, 

and reliability, as well as the 

relationship of this information to 

human risk. A full explanation of the 

data upon which EPA relied and its risk 

assessment based on those data can be 

found within the document entitled 

‘‘Human Health Risk Assessment for the 

New Active Ingredients Bacillus subtilis 

strain RTI477 and Bacillus velezensis 

strain RTI301 in the Proposed 

Manufacturing-use Products 279– 

OAUT, 279–OAUI and End-use 

Products 279–OAUO, 279–OALN and 

279–OALR for FIFRA Section 3 

Registration with Tolerance Exemption 

Petitions’’ (Bacillus subtilis strain 

RTI477 and Bacillus velezensis strain 

RTI301 Human Health Assessment). 

This document, as well as other relevant 

information, is available in docket for 

this action as described under 

ADDRESSES. 

The available data demonstrated that, 

with regard to humans, Bacillus 

velezensis strain RTI301 is not toxic via 

the pulmonary, oral, or dermal routes of 

exposure and is not pathogenic or 

infective via the pulmonary or oral 

routes of exposure. Although there may 

be some dietary and non-occupational 

exposures to residues of Bacillus 

velezensis strain RTI301 when used in 

accordance with label directions and 

good agricultural practices, there is not 

a concern due to the lack of potential for 

adverse effects. Because there are no 

threshold levels of concern with the 

toxicity, pathogenicity, or infectivity of 

Bacillus velezensis strain RTI301, EPA 

determined that no additional margin of 

safety is necessary to protect infants and 

children as part of the qualitative 

assessment conducted. Based upon its 

evaluation in the Bacillus subtilis strain 

RTI477 and Bacillus velezensis strain 

RTI301 Human Health Assessment, 

which concludes that there are no risks 

of concern from aggregate exposure to 

Bacillus velezensis strain RTI301, EPA 

concludes that there is a reasonable 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of Bacillus velezensis strain 

RTI301. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for Bacillus velezensis strain RTI301 

because EPA is establishing an 

exemption from the requirement of a 

tolerance without any numerical 

limitation. 

C. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Bacillus velezensis strain 

RTI301 in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. 

IV. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

EPA. 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, 44 U.S.C. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations 34147 

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 exemption in this action, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (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. As a 

result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

EPA 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, EPA 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 (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

EPA’s consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act (15 

U.S.C. 272 note). 

V. 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: June 21, 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 § 180.1383 to subpart D to read 

as follows: 

§ 180.1383 Bacillus velezensis strain 

RTI301; exemption from the requirement of 

a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus velezensis strain RTI301 in 

or on all food commodities when used 

in accordance with label directions and 

good agricultural practices. 

[FR Doc. 2021–13806 Filed 6–28–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 716 

[EPA–HQ–OPPT–2020–0474; FRL–10020– 

38] 

RIN 2070–AB11 

Health and Safety Data Reporting; 

Addition of 20 High-Priority 

Substances and 30 Organohalogen 

Flame Retardants 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule, issued 

pursuant to the Toxic Substances 

Control Act (TSCA) and the TSCA 

Health and Safety Data Reporting rule, 

requires manufacturers (including 

importers) of 50 specified chemical 

substances to report certain lists and 

copies of unpublished health and safety 

studies to EPA. The chemical 

substances subject to this rule are listed 

in this document and consist of the 20 

designated by EPA as High-Priority 

Substances and the 30 organohalogen 

flame retardants being evaluated for 

risks by the Consumer Product Safety 

Commission (CPSC) under the Federal 

Hazardous Substances Act (FHSA). EPA 

is taking this action because the TSCA 

Interagency Testing Committee (ITC) 

added these chemical substances to the 

Priority Testing List through its 69th and 

74th Reports and EPA will use this 

information to inform the risk 

evaluations currently underway for 20 

High-Priority Substances and for future 

prioritization. 

DATES: This final rule is effective July 

29, 2021. For purposes of judicial 

review, this final rule shall be 

promulgated at 1 p.m. eastern daylight/ 

standard time July 13, 2021 

A request to withdraw a chemical 

substance from this final rule pursuant 

to 40 CFR 716.105(c) must be received 

on or before July 13, 2021. (See Unit IV. 

of the SUPPLEMENTARY INFORMATION.) 

Dates for the reporting requirements 

are enumerated in Unit III.B. of the 

SUPPLEMENTARY INFORMATION. 

ADDRESSES:

Comments. Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2020–0474, by 

using the Federal eRulemaking Portal at 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

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. 

Withdrawal requests. For submission 

of a withdrawal request, see Unit IV. of 

this document. Each withdrawal request 

must be identified by docket ID number 

EPA–HQ–OPPT–2020–0474. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Diana Fahning, Data Gathering and 

Analysis Division (7410M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–8621; email address: 

fahning.diana@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 


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