Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations 7953 

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: February 4, 2022. 

Edward Messina, 

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 § 180.1388 to subpart D to read 

as follows: 

§ 180.1388 Bacillus subtilis strain CH3000; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus subtilis strain CH3000 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2022–02907 Filed 2–10–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0737; FRL–9094–01– 

OCSPP] 

Bacillus paralicheniformis Strain 

CH2970; 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 

paralicheniformis strain CH2970 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. Chr. 

Hansens Laboratory Inc. 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 

paralicheniformis strain CH2970 under 

FFDCA when used in accordance with 

this exemption. 

DATES: This regulation is effective 

February 11, 2022. Objections and 

requests for hearings must be received 

on or before April 12, 2022 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–2020–0737, is 

available at https://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 Public Reading 

Room are 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 Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

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–2020–0737 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 

12, 2022. 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 


lotter on DSK11XQN23PROD with RULES1
7954 Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations 

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 

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– 

2020–0737, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Background 

In the Federal Register of March 22, 

2021 (86 FR 15162) (FRL–10021–44), 

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 

0F8843) by Chr. Hansens Laboratory 

Inc., 9015 W Maple St., Milwaukee, WI 

53214. 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 and nematicide Bacillus 

paralicheniformis strain CH2970 in or 

on all food commodities. That notice 

referenced a summary of the petition 

prepared by the petitioner Chr. Hansens 

Laboratory Inc. and available in the 

docket via https://www.regulations.gov. 

No comments were received on the 

notice of filing. 

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 paralicheniformis strain 

CH2970 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 of 

Bacillus paralicheniformis strain 

CH2970 and Bacillus subtilis strain 

CH3000, New Active Ingredients, in 

CH2970, CH3000, and CH2970/CH3000 

Proposed for Registration and 

Associated Petitions Requesting 

Tolerance Exemptions’’ (Bacillus 

paralicheniformis strain CH2970 and 

Bacillus subtilis strain CH3000 Human 

Health Assessment). This document, as 

well as other relevant information, is 

available in the docket for this action as 

described under ADDRESSES. 

The available data and rationale 

demonstrated that, with regard to 

humans, Bacillus paralicheniformis 

strain CH2970 is not toxic, pathogenic, 

or infective via the pulmonary route of 

exposure when administered 

intratracheally at a single dose of 6.3 x 

108 colony-forming units per test 

animal; is not anticipated to be toxic, 

pathogenic, or infective via the oral 

route of exposure; and is not anticipated 

to be toxic or irritating via the dermal 

route of exposure. Additionally, the 

acute pulmonary toxicity/pathogenicity 

study demonstrated a pattern of 

clearance of Bacillus paralicheniformis 

strain CH2970 from the blood, cecum 

contents, and organs of the test animals. 

Although there may be minimal dietary 

exposure to residues of Bacillus 

paralicheniformis strain CH2970 when 

used in accordance with label directions 

and good agricultural practices, there 

are no risks of human health concern 

due to the lack of potential for adverse 

effects. There are no current or proposed 

uses of Bacillus paralicheniformis strain 

CH2970 that would result in nonoccupational exposures. Because there 

are no threshold levels of concern with 

the toxicity, pathogenicity, or infectivity 

of Bacillus paralicheniformis strain 

CH2970, 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 paralicheniformis strain 

CH2970 and Bacillus subtilis strain 

CH3000 Human Health Assessment, 

which concludes that there are no risks 

of concern from aggregate exposure to 

Bacillus paralicheniformis strain 

CH2970, 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 

paralicheniformis strain CH2970. 

B. Analytical Enforcement Methodology 

An analytical method for detecting 

and measuring pesticide residues is not 

needed for Bacillus paralicheniformis 

strain CH2970 due to the lack of 

potential for adverse effects, which 

supports the establishment of the 

exemption from the requirement of a 

tolerance without any numerical 

limitation. 


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Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations 7955 

C. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Bacillus 

paralicheniformis strain CH2970 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. 

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: February 4, 2022. 

Edward Messina, 

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 § 180.1389 to subpart D to read 

as follows: 

§ 180.1389 Bacillus paralicheniformis 

strain CH2970; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus paralicheniformis strain 

CH2970 in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. 

[FR Doc. 2022–02905 Filed 2–10–22; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket No. 12–375, FCC 21–60; FR 

ID 70815] 

Rates for Interstate Inmate Calling 

Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, an 

information collection associated with 

the Commission’s 2021 Inmate Calling 

Services (ICS) Order, FCC 21–60, in 

which the Commission, among other 

actions, expanded its consumer 

disclosure requirements and added new 

requirements for providers of calling 

services for incarcerated people (calling 

services) that seek waiver of the 

Commission’s interstate and 

international rate caps. The Commission 

also required that calling services 

providers separately disclose, in 

connection with international calling 

services rates, the rate component for 

terminating calls to each country where 

that provider terminates international 

calls. This document is consistent with 

the 2021 ICS Order, which stated that 

the Commission would publish a 

document in the Federal Register 

announcing the effective date of these 

rules. 

DATES: The amendments to 47 CFR 

64.6110 and the addition of 47 CFR 

64.6120, published July 28, 2021 (86 FR 

40682), and delayed indefinitely, are 

effective on February 11, 2022. This rule 

is effective February 11, 2022. 

FOR FURTHER INFORMATION CONTACT: Erik 

Raven-Hansen, Pricing Policy Division, 

Wireline Competition Bureau, (202) 

418–1532, or email erik.raven-hansen@

fcc.gov.@fcc.gov. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on January 

24, 2022, OMB approved, for a period of 

three years, the information collection 

requirements relating to §§ 64.6110 and 

64.6120 of the Commission’s rules, as 

contained in the Commission’s 2021 ICS 

Order, FCC 21–60, published at 86 FR 

40682 on July 28, 2021. The OMB 

Control Number is 3060–1222. The 

Commission publishes this document as 

an announcement of the effective date of 

the rules. 

In the 2021 ICS Order, the 

Commission directed that § 64.6110 be 


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