Comparative analysis of current US and EC biosafety regulations and their impact on the industry

Summary On July 18, 1991, the US National Institutes of Health added a section entitled Good Large-Scale Practice (GLSP) to Appendix K of theGuidelines for Research Involving Recombinant DNA Molecules. Highlights of this section include the requirement for: (i) a health and safety program; (ii) well-trained personnel; (iii) facilities, clothing and practices appropriate to the risk of exposure; (iv) discharges to air, water and soil that must be done in accordance with environmental regulations; (v) aerosol generation that must be kept to a minimum so that employee health is not adversely affected; and (vi) a spill control plan. This complements the blueprint for regulation of biotechnology in the US (Coordinated Framework for Regulation of Biotechnology), in which the jurisdiction of each federal agency is established. Activities in Europe at this time included the adoption of three directives by the European Economic Community: on the protection of workers from risk related to exposure to biological agents at work, on the contained use of genetically modified organisms, and on the deliberate release of genetically modified organisms. The relationship of these new guidelines and regulations to existing practices and their potential impact on future activities are discussed.