Environmental Protection Agency (EPA).
This notice announces Agency approval of an application submitted SafeScience, Inc., now known as GlycoGenesys, Inc. to conditionally register the pesticide product BAITS MOTEL Stay Awhile - Rest ForeverTM 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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 an official public docket for this action under docket identification (ID) number OPP-2002-0300. 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, 1921 Jefferson Davis Hwy., 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 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. The request 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 Start Printed Page 3026electronically 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 Beauveria bassiana strain 447, 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 Beauveria bassiana strain 447 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 this conditional registration is 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 September 19, 2001 (66 FR 48256) (FRL-6791-1), which announced that SafeScience, Inc., now known as GlycoGenesys, 31 St. James Ave., 8th Floor, Boston, MA 02116, had submitted an application to conditionally register the pesticide product, Healthy Indoors Brand, Ant and Cockroach Bait Station, now known as BAITS MOTEL Stay Awhile - Rest ForeverTM, for use as an indoor, non-food use, microbiological bait for control of fire ants and cockroach (EPA File Symbol 70464-U), containing Beauveria bassiana strain 447 at 10%, an active ingredient not included in any previously registered product.
One comment was received in response to the original publication of the notice of receipt of this application. The comment referred to the isolation of the microorganism in Brazil and the recognition of the Brazilian contribution. The applicant, GlycoGenesys, confirmed the original isolation of the fungus in Brazil. Following approved importation and release of the fungus in Gainesville, Florida, the applicant recovered it from release sites in Florida. A biologically pure culture of a novel isolate, specific for imported fire ants, was deposited in the American Type Culture Collection and is recognized as ATCC 20872 (December 29, 1987). Beauveria bassiana strain 447 is the subject of invention in U.S. registered patents, which names the commenter as the co-inventor.
On the basis of data submitted to the Agency, the pesticide was considered acute toxicology Category III for primary eye irritation and IV for acute oral and pulmonary effects. Certain data requirements were waived by the Agency based on the low exposure levels associated with this method of application. Efficacy data support the use of the pesticide as a bait against ants and fire ants. While the active ingredient is efficacious against cockroaches as a spray, its efficacy in the form of a bait needs further study. Because the pesticide is proposed for control of fire ants, it qualifies for an automatic presumptive finding, and its use is presumed to be in the public interest. The conditional registration allows use against ants and fire ants until the applicant provides analysis of five batches to demonstrate adequate production Quality Control and Assurance procedures. Further data are required should the applicant wish to register the pesticide for control of cockroach and other extensive agricultural use patterns. The label prohibits use in/on or near food storage, handling areas, or utensils.
The application was conditionally approved on September 27, 2002 for the end-use product BAITS MOTEL Stay Awhile - Rest ForeverTM (EPA Registration Number 70464-4) for indoor bait use on the basis of data submitted to the Agency. The pesticide contains 10% w/w (1 x 1010 cfu/gram) of the active ingredient Beauveria bassiana strain 447, a new active ingredient. This strain of Beauveria bassiana can be distinguished from the other strains of Beauveria bassiana by isozyme analysis. Like the other strains, it is also an entomopathogenic fungus, which germinates on the cuticles of insects, which it kills by secreting enzymes in their soft tissue .Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: December 23, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.
[FR Doc. 03-970 Filed 1-21-03; 8:45 am]
BILLING CODE 6560-50-S