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Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Cotton Genetically Engineered for Insect Resistance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 28, 2005 (Volume 70, Number 18)]
[Notices]
[Page 4085-4086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja05-48]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-051-1]
Syngenta Seeds, Inc.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Cotton
Genetically Engineered for Insect Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Syngenta Seeds, Inc.,
seeking a determination of nonregulated status for cotton designated as
transformation Event COT102, which has been genetically engineered for
insect resistance. The petition has been submitted in accordance with
our regulations concerning the introduction of certain genetically
engineered organisms and products. In accordance with those
regulations, we are soliciting public comments on whether this cotton
presents a plant pest risk. We are also making available for public
comment an environmental assessment for the proposed determination of
nonregulated status.
DATES: We will consider all comments we receive on or before March 29,
2005.
ADDRESSES: You may submit comments by any of the following methods:
? EDOCKET: Go to http://www.epa.gov/feddocket 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. Once you have entered
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this
document.
? Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-051-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-051-1.
? E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 04-051-1'' on the subject
line.
Reading Room: You may read the petitions, the environmental
assessment, and any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html. 
FOR FURTHER INFORMATION CONTACT: Dr. Margaret Jones, Biotechnology
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-4880. To obtain copies of the
petition or the environmental assessment, contact Ms. Terry Hampton at
(301) 734-5715; e-mail: Terry.A.Hampton@aphis.usda.gov. The petition
and the EA are also available on the Internet at
http://www.aphis.usda.gov/brs/aphisdocs/03_15501p.pdf and
http://www.aphis.usda.gov/brs/aphisdocs/03_15501p_ea.pdf.
SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
``Introduction of Organisms and Products Altered or Produced Through
Genetic Engineering Which Are Plant Pests or Which There Is Reason to
Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
On June 4, 2003, APHIS received a petition (APHIS Petition Number
03-155-01p) from Syngenta Seeds, Inc., (Syngenta) of Research Triangle
Park, NC, requesting a determination of nonregulated status under 7 CFR
part 340 for cotton (Gossypium hirsutum L.) designated as
transformation Event COT102, which has been genetically engineered for
selective lepidopteran insect resistance. The Syngenta petition states
that the subject cotton should not be regulated by APHIS because it
does not present a plant pest risk.
As described in the petition, Event COT102 cotton has been
genetically engineered to contain an insecticidal vip3A(a) gene derived
from Bacillus thuringiensis (Bt) strain AB88 under the control of the
actin-2 promoter derived from Arabidopsis thaliana, which confers
expression of the VIP3A(a) protein throughout the plant with the
exception of the fiber. Event COT102 cotton also contains the
selectable marker gene aph4 derived from Escherichia coli. The aph4
gene encodes the enzyme hygromycinB phosphotransferase and its
expression is controlled by the ubiquitin-3 promoter from A. thaliana.
Agrobacterium-mediated gene transfer was used to transfer the added
genes into the recipient Coker 312 cotton variety. The petitioner
states that while the VIP3A protein shares no homology with known Cry
proteins, testing has shown that VIP3A is similarly specific in toxicity
[[Page 4086]]
only to the larvae of certain lepidopteran species. However, the VIP3A
apparently targets a different receptor than the Cry1 proteins in
sensitive species and therefore may be useful in the management of pest
resistance.
Event COT102 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
the plant pathogen Agrobacterium tumefaciens. This cotton event has
been field tested since 2000 in the United States under APHIS
notifications. In the process of reviewing the notifications for field
trials of the subject cotton, APHIS determined that the vector was
disarmed and that the trials, which were conducted under conditions of
reproductive and physical confinement or isolation, would not present a
risk of plant pest introduction or dissemination.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701-7772),
plant pest is defined as any living stage of any of the following that
can directly or indirectly injure, cause damage to, or cause disease in
any plant or plant product: A protozoan, a nonhuman animal, a parasitic
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or
other pathogen, or any article similar to or allied with any of the
foregoing. APHIS views this definition very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
The U.S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which genetically modified plants allow for a new use of a pesticide or
involve a different use pattern for the pesticide, EPA must approve the
new or different use. Accordingly, Syngenta has submitted a request for
commercial registration of VIP3A as a plant-incorporated protectant.
When the use of the pesticide on the genetically modified plant
would result in an increase in the residues in a food or feed crop for
which the pesticide is currently registered, or in new residues in a
crop for which the pesticide is not currently registered, establishment
of a new tolerance or a revision of the existing tolerance would be
required. Residue tolerances for pesticides are established by EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA)
enforces tolerances set by EPA under the FFDCA. Syngenta has submitted
a request to EPA for a tolerance exemption for both the VIP3A and APH4
proteins as expressed in the subject cotton event. Subsequently, EPA
granted a time-limited exemption from tolerance for the VIP3A protein
and an exemption from tolerance for residues of the APH4 protein.
FDA published a statement of policy on foods derived from new plant
varieties in the Federal Register on May 29, 1992 (57 FR 22984 23005).
The FDA statement of policy includes a discussion of FDA's authority
for ensuring food safety under the FFDCA, and provides guidance to
industry on the scientific considerations associated with the
development of foods derived from new plant varieties, including those
plants developed through the techniques of genetic engineering.
Syngenta has begun consultation with FDA on the subject cotton event.
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for Syngenta's
Event COT102 cotton, an environmental assessment has been prepared. The
EA was prepared in accordance with (1) The National Environmental
Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the environmental assessment prepared to
examine any environmental impacts of the proposed determinations for
the subject cotton event. The petition and the environmental assessment
and any comments received are available for public review, and copies
of the petitions and the environmental assessment are available as
indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and the environmental
assessment and other data and information, APHIS will furnish a
response to the petitioner, either approving the petition in whole or
in part, or denying the petition. APHIS will then publish a notice in
the Federal Register announcing the regulatory status of Syngenta's
insect-resistant cotton event COT102 and the availability of APHIS'
written decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 19th day of January 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-328 Filed 1-27-05; 8:45 am]
BILLING CODE 3410-34-P