Burkholderia cepacia Strain Ral-3; Withdrawal of an Application to Register a Pesticide Product Containing a New Active Ingredient

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Agrium U.S., Inc., has withdrawn its application to register a pesticide product containing the active ingredient Burkholderia cepacia strain Ral-3 (EPA File Symbol 70724-R). The application is withdrawn without prejudice to future filing for registration of products containing Burkholderia cepacia strain Ral-3.

FOR FURTHER INFORMATION CONTACT:

Denise L. Greenway, c/o Product Manager 91, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, telephone number (703) 308-8263, e-mail address: greenway.denise@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

Although this action only applies to the registrant in question, it is directed to the public in general. Since various individuals or entities may be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, please consult the person listed under “FOR FURTHER INFORMATION CONTACT.”

II. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPP-30451B. The official record consists of the documents specifically referenced in this action and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

III. Background Information

EPA issued a notice in the Federal Register on March 24, 1998 (63 FR 14114) (FRL-5780-3), which announced the Agrium U.S., Inc. submission of an application to register a pesticide product (EPA File Symbol 70724-R) containing an active ingredient, the microbial pesticide Burkholderia cepacia strain Ral-3, an active ingredient not included in any previously registered pesticide product. Subsequently, EPA issued a correction notice in the Federal Register on April 15, 1998 (63 FR 18410) (FRL-5783-3) for the microbial pesticide Burkholderia cepacia strain Ral-3.

The application was the subject of a joint review with the Pest Management Regulatory Agency of Health Canada, where the application was also withdrawn from further consideration by the applicant.

EPA received comments from the Allegheny University of the Health Sciences, the University of Edinburgh Medical School, Children's Hospital of Oklahoma, the University of British Columbia, and the Cystic Fibrosis Foundation. EPA co-chaired and participated in a symposium entitled, “Burkholderia cepacia-Friend or Foe?,” at a joint meeting of the American Phytopathological Society (APS) and the Entomological Society of America (ESA). EPA held and participated in an inter-Agency meeting entitled, “Risk Assessment for Intentional Use of Opportunistic Pathogens,” with the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the National Institute of Environmental Health Sciences, and Health Canada. EPA also participated in several meetings of the International Burkholderia cepacia Working Group (IBCWG) and held and participated in a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting entitled, “Burkholderia cepacia: Risk Assessment of a Biopesticide with Affinities to a Human Opportunistic Pathogen,” a record of which is available at http://www.epa.gov/scipoly/sap/1999/index.htm#july.

IV. What Action is the Agency Taking?

EPA is announcing that Agrium U.S., Inc., South Ulster St., Suite 1400, Denver, CO 80237, has withdrawn its application to register a microbial pesticide containing Burkholderia cepacia strain Ral-3, as provided for in section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by the Food Quality Protection Act of 1996 (FQPA). Burkholderia cepacia strain Ral-3 is an active ingredient not included in any previously registered pesticide product. Burkholderia cepacia strain Ral-3 had been proposed as a microbial pesticide for commercial indoor application to seed and/or seedlings of conifers and deciduous trees.

List of Subjects

• Environmental protection
• Pesticides and pests