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The specialized agencies of the United Nations with responsibilities for public health, environmental protection, workers' health, industrial development, and the production of food, biologicals, and vaccines are currently developing “UN” minimal guidelines for biotechnology safety. The work is being conducted by the informal UNIDO/WHO/UNEP Working Group on Biotechnology Safety. Representatives of the United Nations (UN) Industrial Development Organization (UNIDO), the World Health Organization (WHO), and the UN Environment Program (UNEP) are full members of the working group. The UN Food and Agriculture Organization (FAO), the International Labor Organization (ILO), and the Organization for Economic Cooperation and Development (OECD) participate as observers.
The reasons for undertaking development of these guidelines include (1) requirements of individual programs, (2) the need for an international norm, and (3) use by developing and other countries where such guidelines do not exist. Several studies were undertaken prior to work on the guidelines. These included a review of (1) current views of the risks associated with laboratory research, large-scale operations, and environmental application; (2) existing national legislation; (3) awareness of biosafety in the developing countries; and (4) various approaches to biotechnology safety application.
The guidelines are in three parts: (1) safety guidelines for laboratory safety practice, including biological containment; (2) safety guidelines for large-scale (scaleup) practice; and (3) safety and risk assessment guidelines for release of genetically engineered organisms to the environment. After completion, the draft guidelines are scheduled to be “tested” in several interested developing countries. Following the testing procedure, the guidelines will be redrafted as necessary and then reviewed by a panel of experts.
bioprocessing, biotechnology safety, United Nations agencies, World Health Organization, United Nations Industrial Development Organization, United Nations Environment Program, Organization for Economic Cooperation and Development, European Federation of Biotechnology
Director, WHO Collaborating Center for Applied Biosafety Programs and ResearchNational Institutes of Health, Bethesda, MD