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The American Society for Microbiology (ASM) is submitting the following statement in response to the Food and Drug Administration's Federal Register Notice of October 25, 1999 (Docket No. 99N-4282) requesting public comment on issues within the FDA's jurisdiction related to foods derived from plants developed using bioengineered techniques.
The American Society for Microbiology, which represents over 41,000 microbiologists worldwide, has a special interest in issues and policies related to biotechnology research and development. The ASM includes scientists working in academic, governmental and industrial institutions with expertise in molecular biology and genetics, environmental microbiology, medical microbiology and infectious diseases and agricultural and industrial microbiology, including the microbiology of food. ASM members pioneered molecular genetics and were principals in the discovery and application of recombinant DNA procedures which have advanced biotechnology's prominence. Moreover, ASM members have for several decades participated in discussions concerning biotechnology before federal agencies and Congress.
Since the inception of bioengineering in the 1970s, the ASM has examined safety issues associated with biotechnology and its applications. The ASM believes that oversight and regulation should be firmly based on scientific principles and practices. The ASM has long expressed the opinion that regulation would be based on risk associated with the products of biotechnology and not on the process used to create or to produce these products. The ASM participated, and some of its members provided leadership in the development of the NIH Guidelines for Recombinant DNA Research, which include sections applicable to working with plants. The ASM has a continuing working relationship with the U.S. Department of Agriculture and the Environmental Protection Agency, providing experts to advise on plant-microbe interactions, whether engineered or not. The ASM also has provided expertise to the FDA in assessing the safety of foods, including bioengineered products.
The ASM has advised repeatedly that policy regulating biotechnology should focus on organisms that pose significant risk. This is necessary not only to protect public health and the environment, but also to encourage continued biotechnological research and development, which is in the national interest. Indeed, the FDA is to be commended for constructing a framework for safety evaluation that is product based, and for taking the position "that the critical consideration in evaluating the safety of (bioengineered) foods should be the objective characteristics of the food product or its components rather than the fact that new development methods were used."
Benefits and Impact of Bioengineered Foods:
The ASM believes that most of the benefits of bioengineered foods are yet to be realized. While many processed foods contain bioengineered components, their availability, cost, taste and safety are not affected. An important product that consumers have a direct benefit from currently is cheese made with the use of a bioengineered enzyme that replaces the enzyme obtained from calves' stomachs. The availability of certain foods, such as the Hawaiian papaya, rests on bioengineering; plant viruses were killing the trees and fruit. In the research pipeline are foods that have lowered or no allergens, enhanced nutritional content such as vitamins and minerals, naturally decaffeinated coffee and food with medicinal benefits such as antioxidants and vaccines. Indirectly, consumers will benefit from plants that resist pests and pathogens that produce deleterious compounds such as aflatoxins, the most potent carcinogenic agents yet known. Such mycotoxins also cause pain and suffering to animals that consume them. Producers, including home gardeners, will be exposed to fewer synthetic pesticides. Such pesticides can adversely affect health, nontarget organisms and water quality. Bioengineered products are thoroughly evaluated for untoward safety effects for people and the environment, and such testing is expected to continue.
Public Information Issues:
In closing, the ASM would like to emphasize to the Administration and Congress the critical role of the Food and Drug Administration and the importance of providing the agency with adequate resources to accomplish its mission of protecting the public health.