Source: https://www.federalregister.gov/documents/2017/03/22/2017-05720/aspergillus-flavus-af36-amendment-to-an-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2017-04-26 10:11:56
Document Index: 51385887

Matched Legal Cases: ['art 178', 'art 178', 'art 2', 'art2', '§\u2009180', '§\u2009180']

:: Aspergillus flavus AF36; Amendment to an Exemption From the Requirement of a Tolerance
82 FR 14631
14631-14632
EPA-HQ-OPP-2016-0566
FRL-9959-92
Review of Human Health Effects and Product Performance data...
Label Amendment and Environmental Risk Assessment to Add Use...
Arizona Cotton Research and Protection Council Notice of...
https://www.federalregister.gov/d/2017-05720
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0566, 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(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-2016-0566 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 May 22, 2017. 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-2016-0566, by one of the following methods:
In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-9954-06), 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 6E8471) by Interregional Research Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.1206 be amended by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on almond and fig. That document referenced a summary of the petition prepared by the petitioner IR-4, which is available in the docket via 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 Start Printed Page 14632occupational 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 Aspergillus flavus AF36 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 February 2017, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus AF36.” 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 Aspergillus flavus AF36 is not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when Aspergillus flavus AF36 is used on fig and almond in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for 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 Aspergillus flavus AF36.
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 Aspergillus flavus AF36. Therefore, the existing tolerance exemption for Aspergillus flavus AF36 is amended by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on almond and fig when used in accordance with label directions and good agricultural practices.
Start Amendment Part2. In § 180.1206, add paragraph (e) to read as follows: End Amendment Part
§ 180.1206 Aspergillus flavus AF36; exemption from the requirement of a tolerance.
(e) An exemption from the requirement of a tolerance is established for residues of Aspergillus flavus AF36 in or on almond and fig when used in accordance with label directions and good agricultural practices.
[FR Doc. 2017-05720 Filed 3-21-17; 8:45 am]