Modern Biotechnology: a Review of Current Regulatory Status and Identification of Research and Regulatory Needs

Abstract

Modern biotechnology encompasses many technologies. The one that has generated the most public interest is that of genetic engineering. The field has advanced dramatically since the early 1970's, when concern was so high that a moratorium was declared on research using recombinant DNA. Today there are numerous products such as human growth hormone, interferon and monoclonal antibody diagnostic kits on the market. Despite the obvious benefits of these products, there are still concerns over the environmental application of genetically engineered organisms. Many countries have assessed their existing legislation to ascertain its adequacy to regulate such intended releases. Numerous international organizations are becoming involved as well, and optimistically, regulations that are being developed in various countries may be harmonized. These activities have identified several areas where more information is required, including microbial taxonomy and classification, pathogenicity in target and non-target species, environmental behavior and risk assessment processes. Consensus at this time appears to be that our predictive capabilities are still developing and that new organisms should be evaluated on a case-by-case basis.

In contrast to chemicals, where our risk assessment procedures have developed over the years, there are still questions as to whether these procedures are suitable for assessing the risk of genetically engineered organisms.

A brief overview of the technologies involved, the regulatory strategies that are evolving and the areas where research is needed to enable appropriate regulations to be developed are presented.

Keywords

genetic engineering international organizations recombinant DNA technologies regulation research.

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