||Meeting Minutes of FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) Scientific Advisory Panel Meeting, June 8-10, 2004, held at the Holiday Inn Arlington, Arlington, Virginia. A Set of Scientific Issues Being Considered by the U.S. Environmental Protection Agency Regarding: Product Characterization, Human Health Risk, Ecological Risk, And Insect Resistance Management For 'Bacillus thuringiensis' (Bt) Cotton Products.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP) has completed its review of the set of scientific issues being considered by the Agency pertaining to its review of product characterization, human health risk, ecological risk, and insect resistance management for 'Bacillus thuringiensis' (Bt) cotton products. Advance notice of the meeting was published in the Federal Register on May 12, 2004. The review was conducted in an open Panel meeting held in Arlington, Virginia, from June 8-10, 2004. The meeting was chaired by Gary Isom, Ph.D. Mr. Paul Lewis served as the Designated Federal Official. Mr. Joseph J. Merenda, Jr. (Director, Office of Science Coordination and Policy, EPA) and Janet Andersen, Ph.D. (Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA) offered opening remarks at the meeting. Mr. Leonard Cole (Office of Pesticide Programs, EPA) provided an introduction and highlighted the goals and objectives of the meeting. The Agency's product characterization and human health safety assessment for stacked plant-incorporated protectants, environmental effects assessment for WideStrike cotton, and issues related to establishing an insect resistance management plan for WideStrike cotton were presented by John Kough, Ph.D. (Office of Pesticide Programs, EPA), Zigfridas Vaituzis, Ph.D. (Office of Pesticide Programs, EPA) and Sharlene Matten, Ph.D. (Office of Pesticide Programs, EPA), respectively. Sharlene Matten, Ph.D. (Office of Pesticide Programs, EPA) concluded the Agencys presentations by discussing Bollgard and Bollgard II cotton bollworm insect resistance management. The Panel concluded that toxicity studies showed no adverse effects at the highest levels tested, either for the individual Cry proteins or for the two proteins together. The Panel agreed with the Agency that combined oral toxicity studies for multiple proteins is not necessary if each protein had been
previously independently tested, unless such testing would be intended to detect any effects produced by interactions between the proteins. Based on the evidence presented in the safety assessment of the single Bt containing strain and the more recent extensive testing of the stacked Cry1F/Cry1Ac material, the Panel concluded that there is little to suggest that the stacked variety poses significantly more risk or unanticipated consequences to agronomic performance than do varieties with either the Cry1F or Cry1Ac genes introduced singly.