Pesticide Product Registrations; Conditional Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of applications to conditionally register the pesticide products Aspergillus flavus NRRL 21882 and afla-guard containing a new active ingredient not included in any previously registered products pursuant to the provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT:

Shanaz Bacchus, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail address: bacchus.shanaz@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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. 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 an official public docket for this action under docket identification (ID) number OPP-2004-0165. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 South Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket 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 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/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. Did EPA Conditionally Approve the Application?

A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest. The Agency has considered the available data on the risks associated with the proposed use of Aspergillus flavus NRRL 21882 and its end-use product afla-guard, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature 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 use of Aspergillus flavus NRRL 21882 and its end-use product afla-guard during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest.

Consistent with section 3(c)(7)(C) of FIFRA, the Agency has determined that these conditional registrations are in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.

III. Conditionally Approved Registrations

EPA issued a notice, published in the Federal Register of April 14, 2004 (69 FR 19845) (FRL-7352-7), which announced that Circle One, One Arthur Street, P.O. Box 28, Shellman, GA 39886-0028, had submitted an application to conditionally register the pesticide product, Aspergillus flavus NRRL 21882, Manufacturing Use Product (EPA File Symbol 75624-R), containing Aspergillus flavus NRRL 21882 at 100%. The company also submitted a request to register an end-use product afla-guard (EPA Registration Number 75624-E) containing Aspergillus flavus NRRL 21882 at 0.01% by weight. This active ingredient is not included in any previously registered products.

The applications were conditionally approved on May 28, 2004 for an end-use product and a technical listed below:

1. afla-guard (EPA Registration Number 75624-2) was conditionally registered as an end-use product containing Aspergillus flavus NRRL 21882 at 0.01% by weight as an active ingredient. This pesticide is to be manufactured as a granular formulation for a single, seasonal, soil application to peanuts at the pre-pegging stage of peanut plant growth. It is to be applied at a rate of 20 pounds end-use product (equivalent to approximately 0.002 pound or 1 gram active ingredient per acre). During research, small scale field trials demonstrate that the pesticide is efficacious in reducing aflatoxin in peanuts by 71 to 98%. As a condition of registration, a large scale field trial is required to further demonstrate the efficacy of the pesticide under regular field conditions. Regardless of treatment with pesticide products containing Aspergillus flavus NRRL 21882, peanut and its food/feed commodities must meet current regulatory requirements for aflatoxin levels.

2. Aspergillus flavus NRRL 21882 (EPA Registration Number 75624-1). This pesticide is to be used as the Technical Grade Active Ingredient or the Manufacturing Use Product for formulation into end-use products for displacement of the aflatoxin-producing strains of Aspergillus flavus from peanuts. Health and ecological effects data submitted and reviewed by the Agency support the conditional registration of the pesticidal active ingredient and the use of the end-use product as described above. An exemption from tolerance for residues for Aspergillus flavus NRRL 21882 was granted simultaneously with the conditional registration of the technical and its end-use product. The condition of registration includes analysis of five production batches to meet Agency requirements.

List of Subjects

• Environmental protection
• Chemicals
• Pesticides and pests