Source: https://www.federalregister.gov/documents/2016/12/01/2016-28884/muscodor-albus-strain-sa-13-and-the-volatiles-produced-on-rehydration-exemption-from-the-requirement
Timestamp: 2019-06-25 22:31:02
Document Index: 479023375

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

Federal Register :: Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration; Exemption From the Requirement of a Tolerance
Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration; Exemption From the Requirement of a Tolerance
A Rule by the Environmental Protection Agency on 12/01/2016
This regulation is effective December 1, 2016. Objections and requests for hearings must be received on or before January 30, 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).
86579-86581 (3 pages)
EPA-HQ-OPP-2014-0919
FRL-9952-88
2016-28884
Marrone Bio Innovations, Inc. (MBI) 601 EP Notice of Filing...
C. Revision to the Requested Tolerance Exemption
https://www.federalregister.gov/d/2016-28884 https://www.federalregister.gov/d/2016-28884
This regulation establishes an exemption from the requirement of a tolerance for residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration in and on all food commodities when used in accordance with label directions and good agricultural practices. Marrone Bio Innovations, 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 Muscodor albus strain SA-13 and the volatiles produced on rehydration under FFDCA.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0919, 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.
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone Start Printed Page 86580number: (703) 305-7090; email address: BPPDFRNotices@epa.gov.
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-2014-0919 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 January 30, 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-2014-0919, by one of the following methods:
In the Federal Register of January 28, 2015 (80 FR 4527) (FRL-9921-55), 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 4F8271) by Marrone Bio Innovations, Inc. (MBI), 2121 Second Street, Suite B-107, Davis, CA 95618. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of sterile grain inoculated with Muscodor albus strain SA-13 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner MBI, which is available in the docket via http://www.regulations.gov. There were no comments received in response to this notice of filing.
EPA revised the active ingredient name from “sterile grain inoculated with Muscodor albus strain SA-13” to “Muscodor albus strain SA-13 and the volatiles produced on rehydration.” The reason for this change is explained in Unit III.C.
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 Muscodor albus strain SA-13 and the volatiles produced on rehydration 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 November 8, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration.” 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 Muscodor albus strain SA-13 is not toxic, is not pathogenic, and is not infective. Further, the volatiles produced by Muscodor albus strain SA-13 are not toxic. Although there may be some exposure to residues of Muscodor albus strain SA-13 when used as a fungicide, nematocide, insecticide or bactericide on food, there is no potential for adverse effects due to the lack of toxicity, pathogenicity, or infectivity. EPA also determined that retention of the Food Quality Protection Act Safety Factor (FQPA SF) was not necessary as part of the qualitative assessment conducted for Muscodor albus strain SA-13 and the volatiles produced on rehydration.
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 Start Printed Page 86581residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration. Therefore, an exemption from the requirement of a tolerance is established for residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration 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 because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
One modification has been made to the requested tolerance exemption. When MBI first submitted this petition in 2014, it described the pesticide chemical as “sterile grain inoculated with Muscodor albus strain SA-13.” After conducting a review of this petition and evaluating a tolerance exemption established in 2005 for another strain of Muscodor albus (QST 20799) (70 FR 56569), which has the same mode of action as Muscodor albus strain SA-13, EPA is changing the pesticide chemical name to “Muscodor albus strain SA-13 and the volatiles produced on rehydration.” This revision better reflects the possible residues that may occur on food commodities and the data/information submitted to support the petition.
This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Jack Housenger,
2. Add § 180.1340 to subpart D to read as follows:
§ 180.1340
Muscodor albus strain SA-13 and the volatiles produced on rehydration; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration in or on all food commodities when used in accordance with label directions and good agricultural practices.
[FR Doc. 2016-28884 Filed 11-30-16; 8:45 am]