March 3, 1986 Honorable Lee M. Thomas Administrator U. S. Environmental Protection Agency 401 M Street, S. W. Washington, D. C. 20460 Dear Mr. Thomas: The Science Advisory Board's Executive Committee transmitted, on February 7, the final report of its Study Group on Biotechnology which evaluated the Agency's research and regulatory programs for this evolving technology. Among the conclusions reached by the Study Group was the need for a broader research effort to improve the Agency's capability for risk assessment of genetically altered organisms, general endorsement of the preliminary policy statement for testing, and the need for the development of additional test protocols to comply with current and future regulatory requirements. The Study Group also reccmmended the creation of an advisory canmittee to provide a continuing independent review of the technical adequacy of risk assessments prepared by the Agency before granting experi- mental use permits. In judging the need for a separate caimittee, the Study Group and the Executive Committee assumed that confidential business information (CBI) would constitute a significant portion of the technical data submitted by individuals and organizations seeking.an EPA permit, and that the number of permit petitions would grew significantly in future years. Because the Science Advisory Board is a public advisory body whose members are not generally cleared for CBI data, it is the Board's recommendation that the new biotechnology scientific advisory canmittee should be separate frcm the Science Advisory Board. It would be useful, where circumstances warrant, to have overlapping membership between this canmittee and the Science Advisory Board. In addition, we recommend that the canmittee chair serve as a member of the SAB Executive Canmittee. The Executive Canmittee discussed these and other issues with the Assistant Administrator for Pesticides and Toxics Substances, John Moore, during its January 30-31 meeting. Dr. Moore's conception of the role of this ccranittee, as it would function under the umbrella of the proposed interagency Biotechnology Science Coordinating Canmittee, closely matched the views of the Executive Committee. In addition, there was consensus that the Science Advisory Board should maintain a parallel standing SAB-EC-86-014 O c f ; c. £ O f r — £ ijMiNlSTHA r 3^ ------- - 2 - subcommittee to review the research program, including the development of risk assessment methods. These two scientific bodies could, as appropriate, conduct joint reviews of specific issues or projects. In short, the SAB Executive Ccrnmittee endorses the EPA intent to establish a committee to review the technical basis for biotechnology permit applications. Such a ccrnmittee, as currently designed, would not duplicate the advisory role of the SAB and, in fact, would complement the existing and.continuing role of the SAB. Sincerely, , Uwc N6k"ton felson Chairman Executive Committee Science Advisory Board ------- |