Federal Register: December 16, 2002 (Volume 67, Number 241)
DOCID: FR Doc 02-31567
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket ID: [Docket No. 02-092-1]
NOTICE: NOTICES
ACTION: Environmental statements; availability, etc.:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Aventis CropScience; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Cotton Genetically Engineered for Glufosinate Herbicide Tolerance
DATES: We will consider all comments that we receive on or before February 14, 2003.
DOCUMENT SUMMARY:
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Aventis CropScience seeking a determination of nonregulated status for cotton designated as Transformation Event LLCotton25, which has been genetically engineered for tolerance to the herbicide glufosinate. 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.
SUMMARY:
Nonregulated status determinations—; Aventis CropScience; genetically engineered cotton,
SUPPLEMENTAL 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 February 12, 2002, APHIS received a petition (APHIS Petition No.
0204201p) from Aventis CropScience (Aventis) 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 LLCotton25 (LLCotton25), which has been
genetically engineered for tolerance to the herbicide glufosinate. The
Aventis 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, LLCotton25 has been genetically
engineered to contain a stably integrated bar gene isolated from Streptomyces
[[Page 77035]]
hygroscopicus, strain ATCC21705. The bar gene encodes phosphinothricin
Nacetyltransferase (PAT), and the PAT enzyme catalyzes the conversion
of Lphosphinothricin, the active ingredient in glufosinate, to an
inactive form, thus conferring resistance to the herbicide. Expression
of the added genes is controlled in part by gene sequences from the
plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens.
Agrobacteriummediated gene transfer was used to transfer the added genes into the recipient Coker 312 cotton variety.
LLCotton25 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. This cotton has been field tested since 1999 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 vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical containment 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. 77017772), ``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, Aventis has submitted a pesticide petition to EPA to expand the registration of glufosinate to include use on LLCotton25.
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.
FDA published a statement of policy on foods derived from new plant varieties in the Federal Register on May 29, 1992 (57 FR 2298423005). 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. The petitioner has begun consultation with FDA on the subject cotton.
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 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 (EA) prepared to provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risk associated with a proposed determination of nonregulated status for Aventis' LLCotton25.
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). The petition and the environmental assessment and any comments received are available for public review, and copies of the petition and the environmental assessment may be ordered (see 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 Aventis' herbicidetolerant LLCotton25 and the availability of APHIS' written decision.
Authority: 7 U.S.C. 166, 1622n, 7756, and 77617772; 31 U.S.C. 9701;7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 10th day of December 2002. Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 0231567 Filed 121302; 8:45 am]
BILLING CODE 341034P
FOR FURTHER INFORMATION CONTACT
Dr. Susan Koehler, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 207371236; (301) 7344886. To obtain a copy of the petition or the environmental assessment, contact Ms. Kay Peterson at (301) 7344885; email: Kay.Peterson@aphis.usda.gov.