Source: https://www.federalregister.gov/documents/2018/04/20/2018-08309/bacillus-licheniformis
Timestamp: 2020-07-10 09:28:01
Document Index: 183909363

Matched Legal Cases: ['art 178', 'art 178', 'art 2', 'art 180', '§\u2009180', '§\u2009180']

Federal Register :: Bacillus Licheniformis
A Rule by the Environmental Protection Agency on 04/20/2018
17496-17498 (3 pages)
EPA-HQ-OPP-2017-0185
FRL-9971-54
Tolerance Exemption Evaluation: Bacillus licheniformis strain...
FMC Corporation Notice of Filing Pesticide Petition #[not yet...
https://www.federalregister.gov/d/2018-08309
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus licheniformis strain FMCH001 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 the exemption from a requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus licheniformis strain FMCH001 under FFDCA.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0185, 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. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
Start Further Info Start Printed Page 17497
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-2017-0185 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 19, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
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-2017-0185, by one of the following methods:
In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-50), 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 petition (PP 6F8514) by FMC Corporation, FMC Tower at Cira Centre South, 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 Bacillus licheniformis strain FMCH001 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner FMC Corporation, which is available in the docket via http://www.regulations.gov. No comments were received on the notice of filing.
EPA added “in or on all food commodities” to align with the Agency's language and to more clearly define the petitioner's request.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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 toxicity and exposure data on Bacillus licheniformis strain FMCH001 and considered its 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 that data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus licheniformis strain FMCH001.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.
Based upon its evaluation, EPA concludes that Bacillus licheniformis strain FMCH001 is not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when used on all food commodities in accordance with label directions and good agricultural practices, there is a reasonable certainty that such exposure will not cause adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Bacillus licheniformis strain FMCH001.
Based upon its evaluation, 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 licheniformis strain FMCH001. Therefore, an exemption from the requirement of a tolerance is Start Printed Page 17498established for residues of Bacillus licheniformis strain FMCH001 in or on all food commodities when used in accordance with label directions and good agricultural practices.
EPA is establishing an exemption from a tolerance on all food commodities without any numerical limitation and thus an analytical method is not required for enforcement purposes.
2. Add § 180.1350 to subpart D to read as follows:
§ 180.1350
An exemption from the requirement of a tolerance is established for residues of Bacillus licheniformis strain FMCH001 in or on all food commodities when used in accordance with label directions and good agricultural practices.
[FR Doc. 2018-08309 Filed 4-19-18; 8:45 am]