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

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 EPAHQOPP
20190475, 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 204600001.
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 FRL1000317, EPA issued a notice pursuant to FFDCA
section 408d3, 21 U.S.C. 346ad3, 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. EPAs Safety Determination Section 408c2Ai of FFDCA
allows EPA to establish an exemption
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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 408c2Aii 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 408c2B, 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 408b2C, 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 408b2D requires that EPA
consider available information concerning the cumulative effects of a particular pesticides . . . 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, 279OAUI and End-use Products 279OAUO, 279OALN and 279OALR 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
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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 408d 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.

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