[Federal Register Volume 70, Number 138 (Wednesday, July 20, 2005)]
[Notices]
[Pages 41679-41681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14263]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-051-2]


Syngenta Seeds, Inc.; 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 of our determination that cotton 
designated as transformation Event COT102, which has been genetically 
engineered for insect resistance, is no longer considered a regulated 
article under our regulations governing the introduction of certain 
genetically engineered organisms. Our determination is based on our 
evaluation of data submitted by Syngenta Seeds, Inc., in its petition 
for a determination of nonregulated status, our analysis of other 
scientific data, and comments received from the public in response to a 
previous notice. This notice also announces the availability of our 
written determination and our finding of no significant impact.

EFFECTIVE DATE: July 6, 2005.

ADDRESSES: You may read a copy of the determination, the environmental 
assessment and finding of no significant impact, the petition for a 
determination of nonregulated status submitted by Syngenta Seeds, Inc., 
and all comments received on the petition and the environmental 
assessment 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 on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Margaret Jones, Biotechnology 
Regulatory Services, APHIS, 4700 River

[[Page 41680]]

Road Unit 147, Riverdale, MD 20737; (301) 734-4880. To obtain copies of 
the determination, the environmental assessment (EA) and finding of no 
significant impact (FONSI), and the petition, contact Ms. Ingrid 
Berlanger at (301) 734-5715; e-mail: [email protected]. 
The petition and the EA, including the FONSI and determination, 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.
    On January 28, 2005, APHIS published a notice in the Federal 
Register (70 FR 4085-4086, Docket No. 04-051-1) announcing that the 
Syngenta petition and an environmental assessment (EA) were available 
for public review. That notice also discussed the role of APHIS, the 
Environmental Protection Agency, and the Food and Drug Administration 
in regulating the subject cotton and food products developed from it.
    We solicited comments concerning the petition and EA for 60 days 
ending March 29, 2005. We received nine comments by that date, 
submitted by seven individuals (one commenter submitted three copies of 
the same comment). The comments were from a university professor, three 
private individuals, and three anonymous commenters. Two of the 
commenters discussed field trials of genetically modified rice, and a 
third commenter discussed field trials of Syngenta cotton but did not 
address the petition for nonregulated status. None of the four 
remaining commenters supported granting nonregulated status to 
Syngenta's insect-resistant cotton event COT102. The issues raised in 
the comments are addressed in an attachment to the finding of no 
significant impact (FONSI).

Background

    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 and nectar. 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 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.

Determination

    Based on its analysis of the data submitted by Syngenta Seeds, 
Inc., a review of other scientific data, field tests of the subject 
cotton, and comments submitted by the public, APHIS has determined that 
COT102 cotton: (1) Exhibits no plant pathogenic properties; (2) is no 
more likely to become weedy than the nontransgenic parental line or 
other cultivated cotton; (3) is unlikely to increase the weediness 
potential of any other cultivated or wild species with which it can 
interbreed; (4) will not cause damage to raw or processed agricultural 
commodities; (5) will not harm threatened or endangered species or 
organisms that are beneficial to agriculture; and (6) should not reduce 
the ability to control pests and weeds in cotton or other crops. 
Therefore, APHIS has concluded that the subject cotton and any progeny 
derived from hybrid crosses with other non-transformed cotton varieties 
will be as safe to grow as cotton in traditional breeding programs that 
are not subject to regulation under 7 CFR part 340. The effect of this 
determination is that Syngenta's COT102 cotton is no longer considered 
a regulated article under APHIS' regulations in 7 CFR part 340.
    Therefore, the requirements pertaining to regulated articles under 
those regulations no longer apply to the subject cotton or its progeny. 
However, importation of COT102 cotton and seeds capable of propagation 
are still subject to the restrictions found in APHIS' foreign 
quarantine notices in 7 CFR part 319 and imported seed regulations in 7 
CFR part 361.

National Environmental Policy Act

    An EA was prepared to examine any potential environmental impacts 
associated with the proposed determination of nonregulated status for 
the subject cotton. 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). Based on that EA, 
APHIS has reached a FONSI with regard to the determination that 
Syngenta's COT102 cotton and lines developed from it are

[[Page 41681]]

no longer regulated articles under its regulations in 7 CFR part 340. 
Copies of the EA and FONSI are available as indicated in the FOR 
FURTHER INFORMATION CONTACT section of this notice.

    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 14th day of July 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-14263 Filed 7-19-05; 8:45 am]
BILLING CODE 3410-34-P