2011-11519. Syngenta Biotechnology, Inc.; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment of Determination of Nonregulated Status for Lepidopteran-Resistant Cotton

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 Biotechnology, Inc., seeking a determination of nonregulated status for cotton designated as event COT67B, which has been genetically engineered to express a protein to protect cotton plants from lepidopteran insect damage. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are soliciting comments on whether this genetically engineered cotton is likely to pose a plant pest risk. We are making available for public comment the Syngenta petition, our plant pest risk assessment, and our draft environmental assessment for the proposed determination of nonregulated status.

DATES:

We will consider all comments that we receive on or before July 11, 2011.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2007-0130 to submit or view comments and to view supporting and related materials available electronically.
• Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS-2007-0130, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0130.

Reading Room: You may read 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 [phone] before coming.

Availability of Documents: The petition, draft environmental assessment, and plant pest risk assessment are available on the Regulations.gov Web site (see link above) or on the APHIS Web site at http://www.aphis.usda.gov/​brs/​aphisdocs/​07_​10801p.pdf,, http://www.aphis.usda.gov/​brs/​aphisdocs/​07_​10801p _​dea.pdf, and http://www.aphis.usda.gov/​brs/​aphisdocs/​07_​10801p _​dpra.pdf.

FOR FURTHER INFORMATION CONTACT:

Mr. Rick Coker, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], e-mail: [e-mail]. To obtain copies of the petition, draft environmental assessment, or plant pest risk assessment, contact Ms. Cindy Eck at [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), 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.

APHIS has received a petition (APHIS Petition Number 07-108-01p) from Syngenta Biotechnology, Inc. (Syngenta), seeking a determination of nonregulated status for cotton (Gossypium spp.) designated as COT67B, which has been genetically engineered to express a Cry1Ab protein to protect cotton plants from lepidopteran insect damage, stating that cotton event COT67B is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, COT67B cotton produces a full-length Cry1Ab protein originally derived from Bacillus thuringiensis subsp. kurstaki HD-1 which has activity against several important lepidopteran pest species of cotton. These include, but are not limited to, Helicoverpa zea (cotton bollworm), Heliothis virescens (tobacco budworm), Pectinophora gossypiella (pink bollworm), and Trichoplusia ni (cabbage looper). Cotton event COT67B is currently regulated under 7 CFR part 340. Interstate movements and field tests of cotton event COT67B have been conducted under notifications acknowledged by APHIS.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These data are used by APHIS to determine if the new variety poses a plant pest risk. Syngenta has petitioned APHIS to make a determination that cotton event COT67B should not be regulated under 7 CFR part 340.

In section 403 of the Plant Protection Act, “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 has prepared a plant pest risk assessment to determine if cotton event COT67B is unlikely to pose a plant pest risk.

APHIS has also prepared a draft environmental assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Syngenta, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of cotton event COT67B and it would continue to be a regulated article, or (2) approve the petition based on a determination of the nonregulated status of cotton event COT67B in whole.

The draft EA has been prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status for cotton event COT67B. The draft 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 § 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 or affected persons for a period of 60 days from the date of this notice. We are also soliciting written comments from interested or affected persons on the plant pest risk assessment and the draft EA prepared to examine any potential environmental impacts of the proposed determination of the nonregulated status of the subject cotton line. The petition, draft EA, and plant pest risk assessment are available for public review, and copies of the petition, draft EA, and plant pest risk assessment are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All comments received regarding the petition, draft EA, and plant pest risk assessment will be available for public review as indicated under ADDRESSES above. After reviewing and evaluating the comments on the petition, the draft EA, plant pest risk assessment, and other data, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will also publish a notice in the Federal Register announcing the regulatory status of cotton event COT67B and the availability of APHIS' written environmental decision and regulatory determination.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC this 4th day of May 2011.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.