05-14263. 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 [phone] 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 Road Unit 147, Riverdale, MD 20737; [phone]. 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 [phone]; e-mail: [e-mail]. 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 § 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 § 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 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.