01-1522. Notice of Receipt of Request for Cancellation of Registration of Bacillus thuringiensis (B.t.) subspecies tolworthi Cry9C and the Genetic Material Necessary for its Production in Corn

AGENCY:

Environmental Protection Agency (EPA)

ACTION:

Notice.

SUMMARY:

In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of a request by Aventis CropScience USA LP the sole U.S. registrant, to cancel their registration of Bacillus thuringiensis (B.t.) subspecies tolworthi Cry9C and the genetic material necessary for its production in corn.

DATES:

Unless the request is withdrawn, the Agency will approve these use deletions and the deletions will become effective on February 20, 2001.

FOR FURTHER INFORMATION CONTACT:

By mail: Phil Hutton, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

Section 6(f)(1) of FIFRA, provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. The Act further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request.

II. Background

On May 12, 1998, EPA issued a registration to Plant Genetic Systems (America) Inc. for StarLink^TM corn (original EPA Registration No. 70218-1). StarLink^TM contains the active ingredient Bacillus thuringiensis subsp. tolworthi Cry9C protein and the genetic material necessary for its production in corn. EPA issued the registration, but restricted the use of the pesticide to field corn used for feed, industrial non-food uses, and seed increase because the Agency could not find that there was a reasonable certainty of no harm from its use in human food, based on a concern that the protein Cry9C could be allergenic. The Agency's assessment of Cry9C revealed that it has particular characteristics in common with known allergens: it is relatively heat stable and does not readily breakdown in simulated digestive fluids. This raises the possibility that it could be a human allergen. However, EPA determined that, notwithstanding its concern with respect to human ingestion of Cry9C, Cry9C was “safe” and when used as animal feed, would not present unreasonable risks to human health. Because the protein does not transfer to meat and poultry products, use in animal feed would not result in human dietary exposure to the protein/potential allergen.

On October 29, 1998, the StarLink^TM corn registration was conveyed from Plant Genetic Systems (America) to AgrEvo USA. AgrEvo USA and Rhone Poulenc Ag Company subsequently formed Aventis CropScience USA LP (Aventis). As of February 22, 2000, the StarLink^TM corn registration is now held by Aventis under registration number 264-669.

Test data from several sources demonstrate that StarLink^TM corn was diverted into human food. Data from Aventis, Kraft Corporation, and the Food and Drug Administration confirmed the presence of Aventis' Cry9c DNA (the genetic material necessary for the production of Cry9C) in Taco Bell taco shells when tested using polymerase chain reaction (PCR) primers. The PCR primers used are unique to the Aventis cry9c gene.

III. Intent to Cancel Registration

This notice announces receipt by the Agency of an application from Aventis, to cancel the registration for StarLink^TM corn (EPA Registration No. 264-669). The active ingredient in this product is Bacillus thuringiensis subsp. tolworthi Cry9C protein and the genetic material necessary for its production in corn.

The 30-day comment period will permit other interested members of the public to comment prior to the Agency's approval of the deletions. Users of this product who desire continued use should contact both the EPA contact person listed above, and the registrant at the following address: Dr. Sally Van Wert, Aventis CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709; telephone: [phone], to discuss withdrawal of the application for cancellation before February 20, 2001. It should be noted however, that this cancellation is being proposed because Aventis has failed to ensure that StarLink^TM corn will not be diverted to human food, it is incumbent on any proponent of further use to demonstrate either: (1) That further use will not be diverted to human food, or (2) that StarLink^TM corn is safe for human consumption because it will not present an unreasonable allergenic risk.

IV. Existing Stocks Provision

For the purpose of this notice, existing stocks are defined as those stocks of Cry9C corn grain and corn seed (EPA Registration No. 264-669) that exist before the date on which the registration of this product is canceled. Under section 6(a)(1), the Administrator may permit the continued sale or use of existing stocks of a pesticide whose registration has been canceled, if she determines that such sale or use would be consistent with the purposes of FIFRA (7 U.S.C. 136d(a)(1)). Sales of corn grain produced by farmers growing StarLink^TM corn or that corn in the required 660 foot buffer may only be sold or used for domestic animal feed or industrial non-food uses and cannot be sold for planting. No StarLink^TM seed corn may be sold or distributed. Because of significant concerns regarding the potential for StarLink^TM corn to enter the human food stream of commerce, the U.S. Department of Agriculture has undertaken an incentive program to ensure that all StarLink^TM corn currently on the farm is either fed to livestock on the farm, or is directed only to domestic animal feed or industrial non-food uses.

This existing stocks disposition does not prohibit growers from using existing stocks of StarLink^TM grain as animal feed. Nor will feeding animals StarLink^TM corn render meat or milk derived from such animals adulterated. The existing tolerance exemption for the Cry9C protein and the genetic material necessary for its production, found at 40 CFR 180.1192, is not revoked by this Notice.

List of Subjects

• Environmental protection
• Pesticides and pests
• Product registrations

Dated: January 8, 2001.

Susan B. Hazen,

Deputy Director, Office of Pesticide Programs.