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Pesticide Product Registrations; Conditional Approval
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[Federal Register: April 9, 2003 (Volume 68, Number 68)] [Notices] [Page 17372-17374] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap03-59] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2003-0074; FRL-7298-2] Pesticide Product Registrations; Conditional Approval AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces Agency approval of applications submitted by Plant Products Co. Ltd., Brampton, ON L6T 1G1, Canada, to conditionally register the pesticide products Pseudozyma flocculosa strain PF-A22 UL (TGAI) technical grade of the active ingredient and SPORODEX L an end-use product (EP) 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: Sharlene R. Matten, Biopesticides and [[Page 17373]] Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 605-0514; e-mail address: matten.sharlene@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you produce crops or animals or manufacture food or pesticides. Potentially affected entities may include, but are not limited to: ? Crop production (NAICS 111) ? Animal production (NAICS 112) ? Food manufacturing (NAICS 311) ? Pesticide manufacturing (NAICS 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-2003-0074. 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 available for public inspection in the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, Arlington, VA (703) 305-5805. 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.regulations.gov/ 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 Pseudozyma flocculosa strain PF-A22 UL, 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 Pseudozyma flocculosa strain PF-A22 UL 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 October 4, 2000 (65 FR 59185) (FRL-6742-1) (OPP-30500), which announced that Jellinek, Schwartz and Connolly, Inc., 1525 Wilson Blvd., Suite 600, Arlington, VA for Plant Products Co. Ltd., 314 Orenda Road, Brampton, Ontario, Canada, had submitted applications for (EPA file symbols 69697-R and 69697-G) to register pesticide products containing Pseudozyma flocculosa. The following products were approved on September 20, 2002 to control powdery mildew disease on greenhouse-grown cut roses and English seedless cucumbers: 1. Pseudozyma flocculosa strain PF-A22 UL (TGAI) (EPA Registration Number 69697-1). 2. Sporodex L Biological Fungicide (EPA Registration Number 69697- 3). Both conditional registrations were signed on September 20, 2002 and will expire on September 30, 2004. EPA is requiring the registrant to provide data by October 31, 2003 showing detailed analysis of microbial contaminants in production batches, and reporting any incidents of hypersensitivity or other adverse health incidents to workers, applicators, or bystanders. In addition, EPA is requiring storage stability data for Sporodex L Biological Fungicide, and an acute pulmonary infectivity/toxicity study for Pseudozyma flocculosa strain PF-A22 UL (TGAI) by October 31, 2003. After analyzing the submitted data, EPA will decide whether to approve these products for a full registration. List of Subjects Environmental protection, Chemicals, Microbes, Pesticides and pests. [[Page 17374]] Dated: March 31, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 03-8656 Filed 4-8-03; 8:45 am] BILLING CODE 6560-50-S