Source: https://www.federalregister.gov/documents/2016/09/16/2016-22357/aspergillus-flavus-strains-tc16f-tc35c-tc38b-and-tc46g-temporary-exemptions-from-the-requirement-of
Timestamp: 2017-08-18 05:43:16
Document Index: 213218785

Matched Legal Cases: ['art 178', 'art 178', 'art 2', 'art 180', 'art\n2', '§\u2009180', '§\u2009180']

Federal Register :: Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; Temporary Exemptions From the Requirement of a Tolerance
81 FR 63707
FRL-9951-44
C. Revisions to the Requested Tolerance Exemption
https://www.federalregister.gov/d/2016-22357 https://www.federalregister.gov/d/2016-22357
This regulation establishes temporary exemptions from the requirement of a tolerance for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when Start Printed Page 63708used in accordance with the terms of Experimental Use Permit (EUP) No. 91163-EUP-1. Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these temporary tolerance exemptions. This regulation eliminates the need under FFDCA to establish a maximum permissible level for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G when used under the terms of EUP No. 91163-EUP-1. The temporary tolerance exemptions expire on June 30, 2020.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0742, 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-2015-0742 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 November 15, 2016. 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-2015-0742, by one of the following methods:
In the Federal Register of February 9, 2016 (81 FR 6826) (FRL-9941-42), 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 5E8397) by IR-4, Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on corn. 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.
EPA changed the commodity name reflected in the tolerance exemption expression from “corn” to “food and feed commodities of corn, field; corn, pop; and corn, sweet” and changed “tolerance exemption” to “tolerance exemptions”. The reasons for these changes are explained in Unit III.C.
Section 408(r) of FFDCA authorizes EPA to establish a temporary exemption from the requirement of a tolerance for residues covered by an experimental use permit issued under the Federal Insecticide, Fungicide, and Rodenticide Act. That section states that the provisions of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA section 408(r). 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 Start Printed Page 63709exemption 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 strains TC16F, TC35C, TC38B, and TC46G 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 August 18, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G.” 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 strains TC16F, TC35C, TC38B, and TC46G are not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when used on corn in accordance with the terms of EUP No. 91163-EUP-1, 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 strains TC16F, TC35C, TC38B, and TC46G.
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 strains TC16F, TC35C, TC38B, and TC46G. Therefore, temporary exemptions from the requirement of a tolerance are established for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of EUP No. 91163-EUP-1.
An analytical method is not required for enforcement purposes for the reasons contained in the August 18, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G” and because EPA is establishing temporary exemptions from the requirement of a tolerance without any numerical limitation.
Two modifications have been made to the requested tolerance exemption. EPA changed “corn” to “food and feed commodities of corn, field; corn, pop; and corn, sweet” to align with the Agency's food and feed commodity vocabulary. EPA also changed “tolerance exemption” to “tolerance exemptions” as four different active ingredients are covered with this action.
End Authority Start Printed Page 63710 Start Amendment Part
2. Add § 180.1338 to subpart D to read as follows:
§ 180.1338
Temporary exemptions from the requirement of a tolerance are established for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of Experimental Use Permit No. 91163-EUP-1. These temporary exemptions from the requirement of a tolerance expire on June 30, 2020.
[FR Doc. 2016-22357 Filed 9-15-16; 8:45 am]