29056 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides, 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 29, 2022. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter 1 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 § 180.690, amend the table in 

paragraph (a) by designating the table as 

table 1 and adding, in alphabetical 

order, entries for ‘‘Lettuce, head’’; 

‘‘Lettuce, leaf’’; and ‘‘Rapeseed 

subgroup 20A’’. 

The additions read as follows: 

§ 180.690 Mandestrobin; tolerances for 

residues. 

* * * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Lettuce, head .............................. 0.08 

Lettuce, leaf ................................ 4 

Rapeseed subgroup 20A ............ 0.2 

* * * * * 

[FR Doc. 2022–10204 Filed 5–11–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0401; FRL–9783–01– 

OCSPP] 

Streptomyces sp. Strain SYM00257; 

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 Streptomyces 

sp. strain SYM00257 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. Indigo Ag, 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 Streptomyces sp. strain 

SYM00257 under FFDCA when used in 

accordance with this exemption. 

DATES: This regulation is effective May 

12, 2022. Objections and requests for 

hearings must be received on or before 

July 11, 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–2021–0401, 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 and OPP Docket 

is (202) 566–1744. Due to the public 

health concerns related to COVID–19, 

the EPA Docket Center (EPA/DC) and 

Reading Room is open to visitors by 

appointment only. For the latest status 

information on EPA/DC services and 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Biopesticides and 

Pollution Prevention Division (7511M), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(202) 566–2427; 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–2021–0401 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 July 

11, 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 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Rules and Regulations 29057 

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– 

2021–0401, 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 September 

22, 2021 (86 FR 52624) (FRL–8792–03– 

OCSPP), EPA issued notification 

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

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

of a pesticide tolerance exemption 

petition (PP 0F8886) by Indigo Ag, Inc., 

500 Rutherford Ave., Boston, MA 02129. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Streptomyces 

sp. strain SYM00257 in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the petitioner Indigo Ag, Inc. and 

available in the docket via https://

www.regulations.gov. No comments 

were received on the 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 

Streptomyces sp. strain SYM00257 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 

Streptomyces sp. strain SYM00257, a 

New Active Ingredient.’’ 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, Streptomyces sp. strain 

SYM00257 has no demonstrated 

infectivity and low acute toxicity based 

on the toxicity and infectivity study 

results and information presented for 

the active ingredient and its closely 

related species. It is not toxic, 

pathogenic, or infective via the oral 

route of exposure and is not expected to 

be toxic via dermal or inhalation routes 

of exposure based on the data presented 

in those acute toxicity studies. 

Additionally, in the acute oral toxicity/ 

pathogenicity study, Streptomyces sp. 

strain SYM00257 was not detected in 

the blood and organs of the test animals. 

Based on the lack of adverse effects seen 

in the available toxicity/pathogenicity 

data, EPA did not identify any points of 

departure for assessing risk; thus, no 

quantitative risk assessment was 

conducted. Significant dietary and nonoccupational exposures to residues of 

Streptomyces sp. strain SYM00257 are 

not anticipated because it will be used 

only as a pre-planting seed treatment 

application. Additionally, while 

Streptomyces is present in soil, it is not 

expected to reach deep well water and 

therefore, it is not expected to be 

present in drinking water, which is 

either obtained from a deep well, or 

treated and disinfected prior to 

consumption. Even if dietary and nonoccupational exposures to residues of 

Streptomyces sp. strain SYM00257 were 

to occur, there is no 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 Streptomyces sp. strain 

SYM00257, 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 

Streptomyces sp. strain SYM00257 

Human Health Assessment, which 

concludes that there are no risks of 

concern from aggregate exposure to 

Streptomyces sp. strain SYM00257, 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 Streptomyces sp. strain 

SYM00257. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for Streptomyces sp. strain SYM00257 

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 Streptomyces sp. strain 

SYM00257 in or on all food 

commodities when used in accordance 


khammond on DSKJM1Z7X2PROD with RULES
29058 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Rules and Regulations 

with label directions and good 

agricultural practices. 

IV. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

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: April 29, 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 § 180.1392 to subpart D to read 

as follows: 

§ 180.1392 Streptomyces sp. strain 

SYM00257; exemption from the requirement 

of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Streptomyces sp. strain SYM00257 in 

or on all food commodities when used 

in accordance with label directions and 

good agricultural practices. 

[FR Doc. 2022–10163 Filed 5–11–22; 8:45 am] 

BILLING CODE 6560–50–P 


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