Release No. 0560.95 Cynthia A. Eck (301) 734-5931 Jerry Redding (202) 720-6959 USDA RULES GENETICALLY ENGINEERED COTTON SAFE TO GROW Washington, July 13, 1995--The U.S. Department of Agriculture has determined that the Monsanto Company's genetically engineered, insect-resistant cotton lines designated as 531, 757, and 1076 will no longer be considered regulated articles. "After reviewing information submitted by Monsanto, as well as other relevant data and public comments, we have determined that these cotton lines do not present a plant pest risk," Payne said. In November 1994, Monsanto Co., St. Louis, Mo., asked to produce the requested genetically engineered cotton lines trademarked by Monsanto as BollgardTM Cotton Lines without securing further USDA permits or acknowledged notifications, according to John Payne, acting director of biotechnology, biologics, and environmental protection for USDA's Animal and Plant Health Inspection Service. On Feb. 9, USDA published a notice in the Federal Register announcing that the Monsanto petition had been received and was available for public review. USDA 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 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. The cotton lines were considered regulated articles because they contain gene sequences derived from plant pathogens. In cotton-growing locations throughout the United States, cotton line 531 was evaluated under five permits issued between 1991 and 1993, and cotton lines 757 and 1076 were tested under six permits or notifications in 1993 and 1994. Payne said that USDA has the responsibility to assure that in releasing any bioengineered plant, no plant pest risk is presented. APHIS reviewers focus on the biology, propagation, and cultivation of the plant. The reviewers examine the source of the engineered genes, the vector used to transfer them, and the stability of the insertion. An environmental assessment (EA) was prepared to examine the potential environmental impacts associated with this determination. Based on that EA, APHIS reached a finding of no significant impact (FONSI). Copies of the EA, FONSI, determination, petition, and all written comments may be inspected at USDA, Room 1141, South Building, 14th Street and Independence Avenue, S.W., Washington, D.C, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect those documents are asked to call (202) 690-2817 in advance of visiting. The environmental assessment and determination is available also on the APHIS WEB at http://www.aphis.usda.gov/BBEP/BP/. For further information, contact Keith Reding, biotechnologist, biotechnology permits, BBEP, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, Md. 20737-1237; (301) 734-7612. To obtain a copy of the determination or the EA and FONSI, contact Kay Peterson at the same address and telephone number. Notice of this action is published in the July 13 Federal Register and became effective on June 22. #