ASM News Vol 62, Num 10, October 1996, Public Affairs Report

Public Affairs Report

ASM Participates in US/Japan Emerging Diseases Conference

On July 27-28, a Conference on Emerging Diseases, organized by the US-Japan Cooperative Science Program, was held in Kyoto, Japan. ASM joined the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Department of State in sponsoring the Conference, which brought together leading scientists from the US and Japan to discuss recent research advances on emerging infectious diseases and advocacy efforts related to the problem. Gail Cassell, Chair of ASM's Public and Scientific Affairs Board, made a presentation on the health risks and economic impact of emerging antibiotic resistance and chaired an ASM Roundtable discussion on the role of scientific societies in establishing networks and coalitions related to emerging infections.

ASM Responds to Proposed Discontinuance of RAC

The ASM submitted written comments August 1 to the July 8 Federal Register announcement that the Recombinant DNA Advisory Committee (RAC) will be discontinued. The National Institutes of Health (NIH) has proposed that all approval responsibilities for recombinant DNA experiments involving human gene transfer be relinquished to the Food and Drug Administration (FDA), which has statutory responsibility for approvals and that enhancement of NIH oversight of human gene therapy be accomplished through three mechanisms: 1) establishment of the Office of Recombinant DNA Activities (ORDA) Advisory Committee (OAC); 2) implementation of Gene Therapy Policy Conferences (GTPC); and 3) continuation of the publicly available comprehensive NIH database of human gene transfer clinical trials. The ASM commented that there is no need for duplication between the FDA and the NIH in the approval process for gene therapy, but the elimination of the RAC removes an historically important and time tested means of ensuring future progress and public participation in the oversight of recombinant DNA research. The ASM comment letter is available on the ASM Home page or copies can be obtained by calling or emailing the Public Affairs Office (Publicaffairs @asmusa.org).

ASM Sponsors CLIA Quality Control Survey

In August, the Committees on Laboratory Practices and Professional Affairs of the PSAB sponsored a survey on CLIA quality control requirements. The survey was sent to a random sample of laboratories registered with the Health Care Financing Administration (HCFA) to perform microbiology tests and to those individuals certified by the American Board of Medical Microbiology (ABMM). The survey asked respondents to indicate the type and frequency of reagent quality control failures in the laboratory. Results of the survey will be presented as testimony to the Clinical Laboratory Improvement Advisory Committee (CLIAC) in Atlanta in the fall. Brenda McCurdy, one of the authors of the survey commented, "we believe the CLIA regulations mandate excessive quality control frequencies without scientific rationale. We believe the survey will demonstrate extremely low levels of quality control failures. If so, ASM will recommend HCFA revise the microbiology quality control frequencies to appropriate levels". Results of the survey will be reported on in future issues of ASM News.

Plant Pesticide Multi-Society Scientific Report Released

On 1 August, the ASM in conjunction with 10 other scientific organizations released the scientific report, Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests. The report is the product of a scientific meeting held at ASM headquarters on 29-30 January that reviewed the Environmental Protection Agency's (EPA) proposed policy, exemptions and rules, which would regulate plants that have been genetically altered to produce their own pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). A three member panel also briefed congressional staff about the report on August 1. The panel of scientists who participated in the briefing included Anne K. Vidaver, chair of the Public and Scientific Affairs Board Committee on Agricultural, Food and Industrial Microbiology; Jim Cook, former United States Department of Agriculture (USDA), National Research Initiative Chief Scientist and currently with the USDA Agricultural Research Service at Washington State University; and Calvin Qualset with the University of California at Davis in the Genetic Resources Conservation Program. For a copy of the report, please contact the ASM's Office of Public and Scientific Affairs at (202) 942-9209.

For more information, send email to Executivedirector@ asmusa.org