[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Notices]
[Pages 4085-4086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-328]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
[email protected]. 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: [email protected]. 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