Document ID: EPA-HQ-OPP-2019-0474-0003
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Bacillus subtilis strain RTI477
Posted Date: 2021-06-29T04:00Z

[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34142-34145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13804]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0474; FRL-10025-18]

Bacillus subtilis Strain RTI477; Exemption From the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Bacillus subtilis strain RTI477 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 subtilis strain RTI477 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).

[[Page 34143]]

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0474, 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-2019-0474 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 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-2019-0474, 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 9F8749) 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 subtilis strain RTI477 
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. 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

[[Page 34144]]

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 RTI477 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 subtilis strain RTI477 is not toxic via the pulmonary, oral, 
or dermal routes of exposure and is not pathogenic or infective via the 
pulmonary route of exposure. Although there may be some dietary and 
non-occupational exposures to residues of Bacillus subtilis strain 
RTI477 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 
subtilis strain RTI477, 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 subtilis strain RTI477, 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 RTI477.

B. Analytical Enforcement Methodology

    An analytical method is not required for Bacillus subtilis strain 
RTI477 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 RTI477 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.

[[Page 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

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1384 to subpart D to read as follows:

Sec.  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