Source: https://www.federalregister.gov/documents/2014/12/24/2014-30212/beauveria-bassiana-strain-ant-03-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2017-08-21 04:58:14
Document Index: 609393366

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

Federal Register :: Beauveria bassiana Strain ANT-03; Exemption From the Requirement of a Tolerance
EPA-HQ-OPP-2013-0717
FRL-9918-65
Beauveria bassiana strain ANT-03, Petition to establish an...
https://www.federalregister.gov/d/2014-30212 https://www.federalregister.gov/d/2014-30212
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0717, 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.
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2013-0717 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 February 23, 2015. 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-2013-0717, by one of the following methods:
In the Federal Register of December 30, 2013 (78 FR 79359) (FRL-9903-69), 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 3F8176) by Anatis Bioprotection Inc., 278, rang Saint-Andre, St.-Jacques-le-Mineur, Quebec J0J 1Z0, Canada. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Beauveria bassiana strain ANT-03. That document referenced a summary of the petition prepared by the petitioner Technology Sciences Group, Inc. as agent for Anatis Bioprotection Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
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 Start Printed Page 77396“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 the Agency consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to Beauveria bassiana strain ANT-03. EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
A full explanation of the data upon which EPA relied and a summary of its risk assessment based on that data can be found within the October 23, 2014 document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Beauveria bassiana strain ANT-03.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.
Based upon that 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 Beauveria bassiana strain ANT-03. Therefore, an exemption from the requirement of a tolerance is established for residues of Beauveria bassiana strain ANT-03 in or on all food commodities when used in accordance with label directions and good agricultural practices.
An analytical method is not required for enforcement purposes for the reasons contained in the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Beauveria bassiana strain ANT-03,” and because the EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 (PRA), 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).
2. Add § 180.1328 to subpart D to read as follows:
§ 180.1328
An exemption from the requirement of a tolerance is established for residues of Beauveria bassiana strain ANT-03 in or on all food commodities, when applied as a microbial insecticide and used in accordance with label directions and good agricultural practices.
[FR Doc. 2014-30212 Filed 12-23-14; 8:45 am]