Document ID: EPA-HQ-OPP-2008-0162-0005
Agency: epa
Document Type: Notice
Title: Pesticide Product Registration Approval
Posted Date: 2009-08-27T04:00Z

[Federal Register: August 27, 2009 (Volume 74, Number 165)]
[Notices]               
[Page 43697-43698]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au09-73]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0162; FRL-8430-7]

 
Pesticide Product Registration Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT:  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@epa.gov.

SUPPLEMENTARY INFORMATION:

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 http://www.regulations.gov, 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

[[Page 43698]]

from 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 http://www.epa.gov/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 d[eacute]port[eacute]s, 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: http://
www.epa.gov/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.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: August 18, 2009.
 Sheryl K. Reilly,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. E9-20717 Filed 8-26-09; 8:45 a.m.]

BILLING CODE 6560-50-S