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Availability of Determination of Nonregulated Status for Genetically Engineered Cotton
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Availability of Determination of Nonregulated Status for
[Federal Register: July 13, 1995 (Volume 60, Number 134)] [Notices]
[Page 36096-36097]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF AGRICULTURE
[Docket No. 94-139-2]Availability of Determination of Nonregulated Status for Genetically Engineered Cotton
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
SUMMARY: We are advising the public of our determination that the Monsanto Company's genetically engineered, insect-resistant cotton lines designated as 531, 757, and 1076 are no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by the Monsanto Company in its petition for a determination of nonregulated status, an analysis of other scientific data, and our review of comments received from the public in response to a previous notice announcing our receipt of the Monsanto Company petition. This notice also announces the availability of our written determination document and its associated environmental assessment and finding of no significant impact.
EFFECTIVE DATE: June 22, 1995.
ADDRESSES: The determination, an environmental assessment and finding of no significant impact, the petition, and all written comments received regarding the petition may be inspected at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect those documents are asked to call in advance of visiting at (202) 690-2817.
FOR FURTHER INFORMATION CONTACT: Dr. Keith Reding, Biotechnologist, Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the determination or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-7612.
SUPPLEMENTARY INFORMATION:
Background
On November 4, 1994, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 94-308-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination that cotton lines designated as 531, 757, and 1076 that have been genetically engineered for insect resistance do not present a plant pest risk and, therefore, are not regulated articles under APHIS' regulations in 7 CFR part 340.
On February 9, 1995, APHIS published a notice in the Federal Register (60 FR 7746-7747, Docket No. 94-139-1) announcing that the Monsanto petition had been received and was available for public review. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject cotton lines and food products derived from them. In the notice, APHIS solicited written comments from the public as to whether the subject cotton lines posed a plant pest risk. The comments were to have been received by APHIS on or before April 10, 1995. APHIS received 69 comments on the Monsanto petition, from cotton farmers, individuals, universities, agricultural experiment stations, cooperative extension service offices, a bank, a chemical company, a cotton researcher, a cotton cooperative association, a gas and oil supplier, and a worker's compensation trust. Sixty-eight commenters either provided information supporting nonregulated status for the subject cotton lines or urged expedited approval to allow commercial planting of the insect-resistant cotton. One commenter cited several issues for further consideration, without recommending approval or denial of the petition. APHIS has provided a summary and discussion of the comments in the determination document, which is available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.Analysis
Monsanto's cotton lines 531, 757, and 1076 have been genetically engineered to express an insect control protein encoded by the cryIA(c) gene that occurs naturally in Bacillus thuringiensis subsp. kurstaki (Btk), a common soil bacterium. This protein is effective against such lepidopteran insect pests as cotton bollworm, tobacco budworm, and pink bollworm, and is expressed at a consistent level in the cotton plant throughout the growing season. The subject cotton lines also contain the nptII gene which encodes the enzyme neomycin phosphotransferase II. Presence of the NPTII protein confers tolerance to the antibiotic kanamycin and allows selection of the transformed cells in the presence of kanamycin. These genes were stably transferred into the genome of cotton plants using Agrobacterium tumefaciens-mediated transformation. The subject cotton lines have been considered regulated articles under APHIS' regulations in 7 CFR part 340 because they contain gene sequences (vectors, promoters, and terminators) derived from plantpathogenic sources. However, evaluation of field data reports from field tests of the subject cotton lines conducted since 1992 under APHIS permits or notifications indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the subject cotton plants' release into the environment.
Determination
Based on its analysis of the data submitted by Monsanto and a review of other scientific data, comments received from the public, and field tests of the subject cotton lines, APHIS has determined that cotton lines 531, 757, and 1076: (1) Exhibit no plant pathogenic properties; (2) are no more likely to become weeds than their nonengineered parental varieties; (3) are not likely to increase the weediness potential of any other cultivated plant or native wild species with which they can interbreed; (4) will not cause damage to raw or processed agricultural
[[Page 36097]]
commodities; (5) and are not likely to harm other organisms, such as bees, that are beneficial to agriculture. APHIS has also concluded that there is a reasonable certainty that new lepidopteran-resistant cotton varieties bred from these lines will not exhibit new plant pest properties, i.e., properties substantially different from any observed for the lepidopteran-resistant cotton lines already field tested or those observed for cotton in traditional breeding programs. The effect of this determination is that insect-resistant cotton lines designated as 531, 757, and 1076 are no longer considered regulated articles under APHIS' regulations in 7 CFR part 340. Therefore, the permit and notification requirements pertaining to regulated articles under those regulations no longer apply to the field testing, importation, or interstate movement of the subject cotton lines or their progeny. However, the importation of the subject cotton lines or seeds capable of propagation is still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319.National Environmental Policy Act
An environmental assessment (EA) has been prepared to examine the potential environmental impacts associated with this determination. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA)(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 finding of no significant impact (FONSI) with regard to its determination that the subject cotton lines and lines developed from them are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and the FONSI are available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 6th day of July 1995. Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-17080 Filed 7-12-95; 8:45 am] BILLING CODE 3410-34-P