Source: https://www.federalregister.gov/documents/2016/07/21/2016-17275/isaria-fumosorosea-strain-fe-9901-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2018-03-19 02:17:51
Document Index: 123372215

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

Federal Register :: Isaria fumosorosea Strain FE 9901; Exemption From the Requirement of a Tolerance
47309-47311 (3 pages)
EPA-HQ-OPP-2014-0329
FRL-9945-41
Tolerance Exemption Petition for Isaria fumosoroseus strain FE...
Summary of the Petition for Isaria fumosoroseus strain FE 9901...
https://www.federalregister.gov/d/2016-17275 https://www.federalregister.gov/d/2016-17275
This regulation establishes an exemption from the requirement of a tolerance for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices. Novozymes BioAg, 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 Isaria fumosorosea strain FE 9901 under FFDCA.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0329, 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-2014-0329 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 September 19, 2016. Addresses for mail and hand delivery of objections Start Printed Page 47310and 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-2014-0329, by one of the following methods:
In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-67), 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 3F8193) by Technology Sciences Group, Inc., 1150 18th St., NW., Suite 1000, Washington, DC 20036 (on behalf of Novozymes BioAg, Inc., 13100 W. Lisbon Rd., Suite 600, Brookfield, WI 53005). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Isaria fumosoroseus strain FE 9901 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner Novozymes BioAg, Inc., which is available in the docket via http://www.regulations.gov. There were no comments received in response to this notice of filing.
Based upon a tolerance exemption that EPA established for a different strain of this microbe in 2011 and a review of public literature, EPA revised the active ingredient name from “Isaria fumosoroseus strain FE 9901” to “Isaria fumosorosea strain FE 9901.” The reason for this change is explained in Unit III.C.
EPA evaluated the available toxicity and exposure data on Isaria fumosorosea strain FE 9901 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 11, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901.” 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 Isaria fumosorosea strain FE 9901 is not toxic, is not pathogenic, and is not infective. Although there may be some exposure to residues when used as an insecticide on food, 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 (SF) was not necessary as part of the qualitative assessment conducted for Isaria fumosorosea strain FE 9901.
Based on 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 Isaria fumosorosea strain FE 9901. Therefore, an exemption from the requirement of a tolerance is established for residues of Isaria fumosorosea strain FE 9901 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 11, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901” and 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 Novozymes BioAg, Inc. first submitted this petition in 2013, it described the active ingredient as “Paecilomyces fumosoroseus strain FE 9901.” After conducting an initial review of this petition, EPA asked Novozymes BioAg, Inc. to revise the genus name of the active ingredient from “Paecilomyces” to “Isaria” based upon what it believed to be current, acceptable taxonomy. Novozymes BioAg, Inc. responded to EPA's request by representing the active ingredient as “Isaria fumosoroseus strain FE 9901” instead of “Paecilomyces fumosoroseus strain FE 9901” in its petition. After recently reviewing a tolerance exemption established in 2011 for a different strain of this microbe (40 CFR 180.1306 for Isaria fumosorosea Apopka strain 97) and public literature, EPA realizes that it should have also asked Novozymes BioAg, Inc. to change the species name of the active ingredient from “fumosoroseus” to “fumosorosea” to align completely with current, acceptable taxonomy (Refs. 1, 2, and 3). Use of Isaria fumosorosea strain FE 9901 throughout this document is supported by public literature, is consistent with a previous tolerance exemption that EPA established for a different strain of this microbe, and Start Printed Page 47311should assist in preventing confusion with regard to the proper nomenclature for this particular active ingredient in the future. EPA does not believe the change from “fumosoroseus” to “fumosorosea” will cause confusion among the public as there is a clear history linking the first term to the second and because the names refer to the same microbe.
1. U.S. EPA. 2011. Isaria fumosorosea Apopka Strain 97; Exemption From the Requirement of a Tolerance—Final Rule (Dated September 18, 2011). Available from https://www.gpo.gov/​fdsys/​pkg/​FR-2011-09-28/​pdf/​2011-24990.pdf.
2. USDA. 2011. Agricultural Research Service (ARS) Collection of Entomopathogenic Fungal Cultures—Isaria Plus Paecilomyces, Purpureocillium and Evlachovaea (Dated July 28, 2011). Available from http://www.ars.usda.gov/​sp2userfiles/​place/​80620510/​arsefpdfs/​isaria.july2011.pdf.
3. Zimmermann G. 2008. The entomopathogenic fungi Isaria farinosa (formerly Paecilomyces farinosus) and the Isaria fumosorosea species complex (formerly Paecilomyces fumosoroseus): biology, ecology and use in biological control. Biocontrol Science and Technology 18:865-901. Available from http://www.tandfonline.com/​doi/​abs/​10.1080/​09583150802471812.
2. Add § 180.1335 to subpart D to read as follows:
§ 180.1335
An exemption from the requirement of a tolerance is established for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices.
[FR Doc. 2016-17275 Filed 7-20-16; 8:45 am]