Source: https://www.federalregister.gov/documents/2019/08/14/2019-17309/clonostachys-rosea-strain-cr-7-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2019-08-24 11:58:48
Document Index: 312139442

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

Federal Register :: Clonostachys rosea Strain CR-7; Exemption From the Requirement of a Tolerance
This regulation is effective August 14, 2019. Objections and requests for hearings must be received on or before October 15, 2019 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
EPA-HQ-OPP-2016-0641
FRL-9996-35
Bee Vectoring Technology Inc. Notice of Filing Pesticide...
https://www.federalregister.gov/d/2019-17309 https://www.federalregister.gov/d/2019-17309
This regulation establishes an exemption from the requirement of a tolerance for residues of Clonostachys rosea strain CR-7 in or on all food commodities when used in accordance with label directions and good agricultural practices. Bee Vectoring Technology, Inc. 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 Clonostachys rosea strain CR-7 in or on all food commodities under FFDCA.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0641, 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.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Start Printed Page 40270
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-2016-0641 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 October 15, 2019. 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-2016-0641, by one of the following methods:
In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-86), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 6F8508) by Bee Vectoring Technology, Inc., 4160 Sladeview Crescent #7, Mississauga, Ontario L5L 0A1, Canada (c/o Technology Sciences Group, Inc., 1150 18th St. NW, Suite 1000, Washington, DC 20036). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the fungicide Clonostachys rosea strain CR-7 in or on all food commodities. That notice referenced a summary of the petition prepared by the petitioner Bee Vectoring Technology, Inc. and available in the docket via http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit III.C.
EPA evaluated the available toxicity and exposure data on Clonostachys rosea strain CR-7 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 document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Clonostachys rosea strain CR-7” (Safety Determination). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.
The available data demonstrated that, with regard to humans, Clonostachys rosea strain CR-7 is not toxic via the pulmonary, oral, or dermal routes of exposure and is not pathogenic or infective via the pulmonary route of exposure. Although there may be some exposure to residues when Clonostachys rosea strain CR-7 is used on food commodities in accordance with label directions and good agricultural practices, dietary exposure to such residues presents no concern for adverse effects. EPA also determined that a Food Quality Protection Act safety factor (FQPA SF) was not necessary as part of the qualitative assessment conducted for Clonostachys rosea strain CR-7. These findings are discussed in more detail in the Safety Determination.
Based upon its evaluation in the Safety Determination, 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 Clonostachys rosea strain CR-7. Therefore, an exemption from the requirement of a tolerance is established for residues of Clonostachys rosea strain CR-7 in or on all food commodities when used in accordance with label directions and good agricultural practices.
Two comments were received in response to the notice of filing. EPA reviewed the comments and to the extent that they are relevant to the Start Printed Page 40271tolerance exemption in this action, they asked EPA to ensure the public health against adverse effects of pesticides. EPA has evaluated the available information on Clonostachys rosea strain CR-7, including toxicological and potential exposure information, and concluded, in accordance with the statutory requirements of FFDCA, that the exemption would be safe. The commenters provided no basis for a different conclusion.
2. Add § 180.1368 CFR cite to subpart D to read as follows:
§ 180.1368
An exemption from the requirement of a tolerance is established for residues of Clonostachys rosea strain CR-7 in or on all food commodities when used in accordance with label directions and good agricultural practices.
[FR Doc. 2019-17309 Filed 8-13-19; 8:45 am]