[Federal Register: January 18, 2001 (Volume 66, Number 12)]
[Notices]
[Page 4825-4826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja01-73]
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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DATES: Unless the request is withdrawn, the Agency will approve these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:
hutton.phil@epa.gov.
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