[Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
[Notices]
[Pages 4825-4826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1522]


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ENVIRONMENTAL PROTECTION AGENCY

[0PP-60059; FRL-6762-9]


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.

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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DATES: Unless the request is withdrawn, the Agency will approve these 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: (703) 308-8260; e-mail address: 
[email protected].

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 StarLinkTM corn (original EPA 
Registration No. 70218-1). StarLinkTM 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 StarLinkTM 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 
StarLinkTM corn registration is now held by Aventis under 
registration number 264-669.
    Test data from several sources demonstrate that 
StarLinkTM 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 StarLinkTM 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: 
(919) 549-2379, 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 StarLinkTM 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 StarLinkTM 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

[[Page 4826]]

StarLinkTM 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 StarLinkTM 
seed corn may be sold or distributed. Because of significant concerns 
regarding the potential for StarLinkTM corn to enter the 
human food stream of commerce, the U.S. Department of Agriculture has 
undertaken an incentive program to ensure that all 
StarLinkTM 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 StarLinkTM grain as animal feed. 
Nor will feeding animals StarLinkTM 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.

[FR Doc. 01-1522 Filed 1-17-01; 8:45 am]
BILLING CODE 6560-50-S