Van Houten J, Fleming D O
R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ.
J Ind Microbiol. 1993 Jul;11(4):209-15. doi: 10.1007/BF01569593.
On July 18, 1991, the US National Institutes of Health added a section entitled 'Good Large-Scale Practice' (GLSP) to Appendix K of the Guidelines 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 risks 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.
1991年7月18日，美国国立卫生研究院在《涉及重组DNA分子的研究指南》附录K中增加了一个名为“良好大规模操作规范”（GLSP）的部分。该部分的要点包括对以下方面的要求：（i）健康与安全计划；（ii）训练有素的人员；（iii）与暴露风险相适应的设施、服装和操作规范；（iv）向空气、水和土壤的排放必须符合环境法规；（v）必须将气溶胶的产生控制在最低限度，以免对员工健康产生不利影响；以及（vi）溢出物控制计划。这补充了美国生物技术监管蓝图（《生物技术监管协调框架》），其中确立了每个联邦机构的管辖权。当时欧洲的活动包括欧洲经济共同体通过了三项指令：“关于保护工人免受工作中接触生物制剂相关风险的指令”、“关于转基因生物的封闭使用的指令”以及“关于转基因生物的有意释放的指令”。讨论了这些新指南和法规与现有做法的关系及其对未来活动的潜在影响。
