Source: https://www.federalregister.gov/documents/2015/05/18/2015-11960/trichoderma-asperelloides
Timestamp: 2018-04-23 02:21:59
Document Index: 152505086

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

Federal Register :: Trichoderma asperelloides
A Rule by the Environmental Protection Agency on 05/18/2015
This regulation is effective May 18, 2015. Objections and requests for hearings must be received on or before July 17, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
80 FR 28201
28201-28203 (3 pages)
EPA-HQ-OPP-2012-0963
FRL-9926-87
2015-11960
Summary of the Petition for Trichoderma asperelloides strain...
Attachment #2 - Associated with Trichoderma asperelloides...
Attachment #1 - Associated with Trichoderma asperelloides...
Petition for an exemption from the requirement of a tolerance...
Attachment #2 - Associated with Amendment to Initial Petition...
Attachment #1 - Associated with Amendment to Initial Petition...
Amendment to the Initial Petition for Exemption from the...
Summary of the Petition for Trichoderma fertile strain JM41R...
https://www.federalregister.gov/d/2015-11960 https://www.federalregister.gov/d/2015-11960
This regulation establishes an exemption from the requirement of a tolerance for residues of Trichoderma asperelloides strain JM41R in or on all food commodities when used in accordance with label directions and good agricultural practices. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Trichoderma asperelloides strain JM41R under FFDCA.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0963, 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-2012-0963 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 July 17, 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-2012-0963, by one of the following methods:
In the Federal Register of February 21, 2014 (79 FR 9870) (FRL-9904-98), 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 2F8102) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Trichoderma fertile strain JM41R in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner BASF Corporation, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.
Subsequently, the petitioner provided additional data (i.e., DNA sequence Start Printed Page 28202work based on newly published taxonomies) on the identity of the pesticide to EPA. After reviewing these data, EPA concluded that the correct identity of the pesticide was Trichoderma asperelloides strain JM41R and not Trichoderma fertile strain JM41R. In order to give the public an opportunity to comment on this new information, EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55) and placed a revised petition from BASF Corporation into the docket. There were no comments received in response to the republished 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 “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 Trichoderma asperelloides strain JM41R 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 April 20, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Trichoderma asperelloides strain JM41R.” 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 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 Trichoderma asperelloides strain JM41R. Therefore, an exemption from the requirement of a tolerance is established for residues of Trichoderma asperelloides strain JM41R 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 April 20, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Trichoderma asperelloides strain JM41R” and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Start Printed Page 28203
Dated: May 2, 2015.
2. Add § 180.1331 to subpart D to read as follows:
§ 180.1331
Trichoderma asperelloides strain JM41R; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for residues of Trichoderma asperelloides strain JM41R in or on all food commodities when used in accordance with label directions and good agricultural practices.
[FR Doc. 2015-11960 Filed 5-15-15; 8:45 am]