Source: https://www.federalregister.gov/documents/2017/02/24/2017-03580/vnt1-protein-in-potato-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2018-02-23 23:26:00
Document Index: 651206194

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 178', 'art 2', 'art 174', '§\u2009174', '§\u2009174']

Federal Register :: VNT1 Protein in Potato; Exemption From the Requirement of a Tolerance
VNT1 Protein in Potato; Exemption From the Requirement of a Tolerance
A Rule by the Environmental Protection Agency on 02/24/2017
This regulation is effective February 24, 2017. Objections and requests for hearings must be received on or before April 25, 2017 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
82 FR 11513
11513-11515 (3 pages)
EPA-HQ-OPP-2014-0457
FRL-9957-97
J.R. Simplot Company Notice of Filing Pesticide Petition...
J. R. Simplot Company Notice of Filing Pesticide Petition...
EPA File Symbol 891 7-EUP-2 (Rpi-vnt1 gene that expresses the...
Tolerance Petition 4F8251 2202014
C. Revisions to Requested Tolerance Exemption
https://www.federalregister.gov/d/2017-03580 https://www.federalregister.gov/d/2017-03580
This regulation establishes an exemption from the requirement of a tolerance for residues of VNT1 protein in potato when used as a plant-incorporated protectant. J.R. Simplot Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting a permanent exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of VNT1 protein in potato under FFDCA.
This regulation is effective February 24, 2017. Objections and requests for hearings must be received on or before April 25, 2017 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Start Printed Page 11514Unit I.C. of the SUPPLEMENTARY INFORMATION).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0457, 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-2014-0457 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 April 25, 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-2014-0457, by one of the following methods:
In the Federal Register of April 25, 2016 (81 FR 24047) (FRL-9944-86), 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 5F8425) by J.R. Simplot Co., 5369 W. Irving St., Boise, ID 83706. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of VNT1 protein in potato. That document referenced a summary of the petition prepared by the petitioner J.R. Simplot Company, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.
EPA previously established a temporary exemption from tolerance for VNT1 protein in potato (40 CFR 174.534; 80 FR 9387) in conjunction with an Experimental Use Permit (8917-EUP-2) in 2015. This temporary exemption was subsequently amended (extended) on December 17, 2015 and expires on April 1, 2017.
EPA evaluated the available toxicity and exposure data on VNT1 protein 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 December 6, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for VNT1 protein.” This document, as well as other relevant information, is available in the docket Start Printed Page 11515for this action as described under ADDRESSES. 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 VNT1 protein. Therefore, an exemption from the requirement of a tolerance is established for residues of VNT1 protein in potato when used as a plant-incorporated protectant in accordance with the terms of registration.
EPA has determined that an analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. Nonetheless, an analytical method was provided by J.R. Simplot for the detection of VNT1 protein in potato. This method utilizes a quantitative polymerase chain reaction (qPCR) to detect the presence of the Rpi-vntl gene in pSIM1678 transformed plants (pSIM1678 is the transformation vector used by the registrant to incorporate the Rpi-vntl gene into potato varieties). There are numerous homologs of Rpi-vnt1 present in potato and tomato varieties and other wild Solanum species that may result in non-specific amplification when using primers designed to amplify Rpi-vnt1. To distinguish between plants that naturally contain homologous sequences and those transformed with pSIM1678, a second method amplifies a unique junction between the Rpi-vnt1 terminator and the AGP promoter present in the pSIM1678 T-DNA. This second method is intended to confirm the presence or absence of pSIM1678 if there are false positive detection of Rpi-vnt1 homologs.
The current temporary tolerance exemption for VNT1 protein in potato (40 CFR 174.534) approved by EPA on December 17, 2015, will be changed to a permanent tolerance exemption.
Authority: 7. U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
2. Revise § 174.534 to read as follows:
§ 174.534
VNT1 protein; exemption from the requirement of a tolerance.
Residues of VNT1 protein in potato are exempt from the requirement of a tolerance when the Rpi-vnt1 gene that express the VNT1 protein is used as a plant-incorporated protectant in potato.
[FR Doc. 2017-03580 Filed 2-23-17; 8:45 am]