Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Environmental Protection Agency

          - 40 CFR Part 180
          - [EPA-HQ-OPP-2020-0495; FRL-8920-01-OCSPP]

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Final rule.

# SUMMARY:

                        This regulation establishes an exemption from the requirement of a tolerance for residues of                         *Bacillus subtilis*                         strain AFS032321 in or on all food commodities when used in accordance with label directions and good agricultural practices. AFS32321 Crop Protection, 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 subtilis*                         strain AFS032321 under FFDCA when used in accordance with this exemption.                    

# DATES:

                        This regulation is effective April 8, 2022. Objections and requests for hearings must be received on or before June 7, 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-2020-0495, 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 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://ecfr.federalregister.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-2020-0495 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 June 7, 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/​      ( print page 20720)    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 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-2020-0495, 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-send-comments-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 December 21, 2020 (85 FR 82998) (FRL-10016-93), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 9F8816) by AFS32321 Crop Protection, Inc., P.O. Box 14069, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the bactericide and fungicide                     *Bacillus subtilis*                     strain AFS032321 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner AFS32321 Crop Protection, 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 subtilis*                     strain AFS032321 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 “                    *Bacillus subtilis*                     strain AFS032321 (PC Code: 006072) Human Health Risk Assessment in support of Section 3 Product Registration under PRIA Action Code B590—New active ingredient; food use; petition to establish a tolerance exemption” (                    *Bacillus subtilis*                     strain AFS032321 Human Health Risk 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 subtilis*                     strain AFS032321 is not toxic, pathogenic, or infective via the oral route of exposure when administered by oral gavage at a single dose of 5.4 x 108                     colony-forming units per test animal; is not anticipated to be toxic, pathogenic, or infective via the pulmonary route of exposure; is not anticipated to be toxic via the dermal route of exposure; and is moderately irritating via the dermal route of exposure. Additionally, the acute oral toxicity/pathogenicity study demonstrated a pattern of clearance of                     *Bacillus subtilis*                     strain AFS032321 from the organs and feces of the test animals. Although there may be some dietary and non-occupational exposures to residues of                     *Bacillus subtilis*                     strain AFS032321 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. For example, no significant adverse effects have been associated with dietary exposure to                     *Bacillus subtilis*                     group strains, of which this active ingredient is a part, and these organisms are often present in agricultural settings (                    *i.e.,*                     water, soil, and plant roots) and are commonly found on various types of fresh produce. Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of                     *Bacillus subtilis*                     strain AFS032321, 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                           ( print page 20721)                        evaluation in the                     *Bacillus subtilis*                     strain AFS032321 Human Health Risk Assessment, which concludes that there are no risks of concern from aggregate exposure to                     *Bacillus subtilis*                     strain AFS032321, 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 subtilis*                     strain AFS032321.                

### B. Analytical Enforcement Methodology

                    An analytical method is not required for                     *Bacillus subtilis*                     strain AFS032321 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 subtilis*                     strain AFS032321 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: April 1, 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 § 180.1386 to subpart D to read as follows: 

§ 180.1386 

                            An exemption from the requirement of a tolerance is established for residues of                             *Bacillus subtilis*                             strain AFS032321 in or on all food commodities when used in accordance with label directions and good agricultural practices.                         

[FR Doc. 2022-07561 Filed 4-7-22; 8:45 am]

BILLING CODE 6560-50-P