Federal Register: November 19, 2008 (Volume 73, Number 224)
DOCID: fr19no08-37 FR Doc E8-27479
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket ID: [Docket No. APHIS-2007-0016]
ACTION: Environmental Impact Statements; Availability, etc.:
DOCUMENT ACTION: Notice.
Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production
DATES: We will consider all comments we receive on or before January 20, 2009.
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 corn designated as transformation event 3272, which has been genetically engineered to produce a microbial enzyme that facilitates ethanol production. 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 comments on whether this genetically engineered corn is likely to pose a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.
Petition for Determination of Nonregulated Status for Corn Genetically Engineered to Produce an Enzyme that Facilitates Ethanol Production,
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 October 7, 2005, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition No. 0528001p) from Syngenta Seeds, Inc., of Research Triangle Park, NC (Syngenta), for corn (Zea mays L.) designated as transformation event 3272, which has been genetically engineered to produce a microbial enzyme that facilitates ethanol production. The petition stated that Event 3272 corn 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, Event 3272 corn has been genetically engineered to contain two transgenes: (1) The amy797E gene encoding the thermostable AMY797E alphaamylase enzyme and (2) the pmi (manA) gene from Escherichia coli, which encodes the enzyme phosphomannose isomerase, used as a selectable marker. The AMY797E alphaamylase enzyme is a chimeric, thermostable enzyme derived from three alpha amylase genes originating from three hyperthermophilic microorganisms of the archael order Thermococcales. The expression of amy797E is driven by the promoter from a corn seed storage (gammazein) gene, which directs the accumulation of alphaamylase in the corn kernel. The pmi gene is from one of the main species of bacteria living in mammal intestines, E. coli, and is driven by the polyubiquitin promoter from corn.
This genetic insert also contains the terminator sequences from two plant pests, cauliflower mosaic virus and Agrobacterium tumefaciens. Both of these sequences are wellcharacterized, and are noncoding regulatory regions only. These sequences will not cause Event 3272 corn to promote plant disease.
DNA was introduced into corn cells from a proprietary corn line using disarmed (nonplant pest causing) Agrobacterium tumefaciens mediated transformation methodology with the transformation vector designated pNOV7013. Plant cells containing the introduced DNA were selected by culturing in the presence of mannose. After the initial transformation, broadspectrum antibiotic cefotaxime was included in the culture medium to kill any remaining Agrobacterium. Therefore, no part of the plant pest A. tumefaciens is remaining in Event 3272 corn due to the transformation method.
Event 3272 corn has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. Event 3272 corn has been fieldtested in the United States since 2002, as authorized by APHIS notifications and permits. In the process of reviewing the permits for field trials of the subject corn, APHIS determined that the vectors and other elements used to introduce the new genes were 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.
Field tests conducted under APHIS regulatory 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 field test data, in turn, are used by APHIS to determine whether the regulated corn event poses a plant pest risk. Syngenta has petitioned APHIS to make a determination that Event 3272 corn and the progeny derived from its crosses with other nonregulated corn will no longer be considered regulated articles under 7 CFR part 340.
APHIS has prepared an environmental assessment (EA) in which it presents two alternatives for the determination of nonregulated status 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 Event 3272 corn and it would continue to be a regulated article; or (2) the preferred alternative, grant nonregulated status to Event 3272 corn in whole. The EA also describes other alternatives that were initially evaluated but rejected from further consideration in the decision process for reasons explained in the EA.
In section 403 of the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), ``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 PPA definition to cover direct or indirect injury, disease, or damage not just to agricultural crops, but also to other plants, for example, native species, as well as to plant parts and plant products whether natural, manufactured, or processed.
Event 3272 corn is also subject to regulation by other Federal
agencies. The Food and Drug Administration (FDA) policy statement
concerning regulation of products derived from new plant varieties, including those
genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 2298423005). Under this policy, FDA uses what is termed a consultation process to ensure that human and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of a bioengineered food. In compliance with the FDA policy, Syngenta submitted a food and feed safety and nutritional assessment summary to FDA for Event 3272 corn which was completed in August 2007 acknowledging that based on the information available, Event 3272 corn did not raise safety or other issues that would require premarket review or approval by the FDA. As Event 3272 corn does not produce a pesticide or have a tolerance to any pesticide, the Environmental Protection Agency is not involved with evaluating Event 3272.
National Environmental Policy Act
A draft EA has been prepared to inform the public of, and to provide the APHIS decisionmaker with, a review and analysis of potential environmental impacts associated with the proposed determination of nonregulated status for Event 3272 corn. 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 15001508), (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 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 draft EA prepared to examine potential environmental impacts of the proposed determination for the deregulation of the subject corn line. The petition and the draft EA are available for public review, and copies of the petition and the draft EA are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will evaluate all written comments received during the comment period and any other relevant information. All public comments received regarding the petition and draft EA will be available for public review. After reviewing and evaluating the comments on the petition and the draft EA and other data, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Event 3272 corn and the availability of APHIS' written regulatory and environmental decision.
Authority: 7 U.S.C. 77017772 and 77817786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 13th day of November 2008. Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E827479 Filed 111808; 8:45 am]
BILLING CODE 341034P
FOR FURTHER INFORMATION CONTACT
Dr. Andrea Huberty, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD
207371236; (301) 7340485, email: firstname.lastname@example.org. To
obtain copies of the petition or the draft environmental assessment, contact Ms. Cindy Eck at (301) 7340667, email:
email@example.com. The petition and the draft environmental assessment are also available on the Internet at http:// www.aphis.usda.gov/brs/aphisdocs/05_28001p.pdf and http:// www.aphis.usda.gov/brs/aphisdocs/05_28001p_ea.pdf.