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Pesticide Product Registration Approval

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency (EPA).




This notice announces Agency approval of an application to register the pesticide product NEXY containing an active ingredient not included in any previously registered products pursuant to the provisions of section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.

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Jeannine Kausch, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 347-8920; e-mail address: kausch.jeannine

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I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

  • Crop production (NAICS code 111).
  • Animal production (NAICS code 112).
  • Food manufacturing (NAICS code 311).
  • Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0162. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are Start Printed Page 43698from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

In accordance with section 3(c)(2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Such requests should: Identify the product name and registration number and specify the data or information desired.

A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at​fedrgstr.

II. Did EPA Approve the Application?

The Agency approved the application after considering all required data on risks associated with the proposed use of Candida oleophila Strain O, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that Candida oleophila Strain O, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to human health or the environment.

III. Approved Application

EPA issued a notice, published in the Federal Register of March 28, 2008 (73 FR 16676) (FRL-8355-5), which announced that SynTech Global, LLC, P.O. Box 640, Hockessin, DE 19707 on behalf of BioNext sprl, Passage des déportés, 2, B-5030 Gembloux, Belgium, had submitted an application to register the pesticide product, NEXY, biofungicide (EPA File Symbol 84863-R), containing Candida oleophila Strain O at 57%. This product was not previously registered.

The Agency received one public comment in response to the March 28, 2008 notice. A private citizen expressed opposition to Candida oleophila Strain O's introduction into the United States in light of the “thousands of chemicals already out there” and implied a concern about the effects of “toxic chemicals” on human health or the environment. Pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency conducted a rigorous assessment of Candida oleophila Strain O, as described in Unit II, and concluded that it is not expected to cause any unreasonable adverse effects to human health or the environment.

Further, Candida oleophila Strain O is not considered a conventional pesticide. Conventional pesticides generally consist of synthetic materials, may affect a broad spectrum of non-target organisms, and may be inherently more toxic. Candida oleophila Strain O, however, is a naturally occurring yeast isolated from golden delicious apples and found on various food commodities, and has been classified as a microbial pesticide. Candida oleophila Strain O is intended for use as an antagonist to specifically control the fungal pathogens gray mold (Botrytis cinerea) and blue mold (Penicillium expansum), which cause post-harvest decay on apples and pears. The mode of action for Candida oleophila Strain O is primarily through competition for nutrients and pre-colonization of plant wound sites, and use of Candida oleophila Strain O may result in decreased conventional pesticide applications to apples pears after harvest. Additional information about Candida oleophila Strain O and the Agency's assessment of this microbial active ingredient can be found in the Biopesticides Registration Action Document (BRAD) on the Biopesticides and Pollution Prevention Division (BPPD) website:​pesticides/​biopesticides.

The application was approved on June 1, 2009, as NEXY (EPA Registration Number 84863-1) for post-harvest control of gray mold (Botrytis cinerea) and blue mold (Penicillium expansum) on apples and pears.

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Dated: August 18, 2009.

Sheryl K. Reilly,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

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[FR Doc. E9-20717 Filed 8-26-09; 8:45 a.m.]