COLLEGE PARK, Md. _ Almost a quarter of a century afterscientists first altered plasmids through genetic engineering, officialshave yet to agree on the nature, or the extent, of the risks posed by theproducts of biotechnology.But now, as genetic engineering becomes a mainstay ofpharmaceutical, agricultural and industrial science, the difficulties of_ and the need for _ risk assessment promises to become apreoccupation for years to come.David MacKenzie, director of biotechnology for the U.S. Departmentof Agriculture (USDA), on Wednesday called risk assessment "anemerging field" and said that experts are trying to take the knowledgegained in assessing health risks to humans and apply it toenvironmental science.Speaking at a meeting on the subject sponsored by the USDA and theUniversity of Maryland Biotechnology Institute here, MacKenzie said,"We've got to figure out what constitutes risk and find some way ofminimizing it. If we don't, you could see a public reaction againstbiotechnology."The annual scientific meeting drew about 200 participants, the largestturnout ever, indicating growing interest. The group's purpose is purelydiscussionary; no formal report or recommendation was proffered.It is unlikely that any geneticist could forget the public outcry thatgreeted news of the first cloning experiments. Much of the concern inthe early stages of biotechnical investigation, however, centered onresearch and development.Now, with such products as Calgene Inc.'s Flavr Savr tomato comingto market, MacKenzie said protest is more likely to center on thecommercialization of genetically engineered items _ and whetherindustry and government have taken adequate precautions to protectthe public and the environment.The trouble is, neither the government nor industry know where tobegin. "What is the starting point?" MacKenzie asked. "If we decide toundertake risk assessment of all products of biotechnology, that wouldbe a tremendous expense."Different government agencies have different standards, as the result ofa 1986 decision handed down by the Reagan administration. Under thepolicy, established by the White House Office on Science andTechnology, the products of biotechnology are governed underregulations that were already on the books for drugs, pesticides andother risky substances.As a result, different agencies have different jurisdictions. TheEnvironmental Protection Agency concerns itself with gene transfersfrom one organism to another. The USDA can regulate processes thatpose a risk of transforming a plant into a weedy pest. The FDA fretsover the safety and wholesomeness of genetically altered foods."There is no paradigm _ it's rather an ad hoc approach," said RebeccaGoldburg, a senior scientist at the Environmental Defense Fund.Scientists attending the Maryland meeting said that new researchclearly indicates that biotechnology poses unsuspected risks.Jack Brown, of the University of Idaho in Moscow, said that hisresearch into genetically engineered herbicide resistance indicates thatthis trait can be introduced into related weed species through crosspollination.The three-year study (which began six months ago) of Canola plantsand related vegetation has already produced herbicide-resistant weeds."All indications we have at this preliminary stage say, yes, this willoccur," he told the meeting.And David TeBeest, of the University of Arkansas in Fayetteville, hasfound that genes from the fungus Colletotrichum gloeosporides can betransferred from one strain to another _ a fact that calls into questionhalf a century of careful observation suggesting that this could notoccur."What we thought was an isolated fungus that could be used as abiocontrol agent, in fact, has been exchanging genes all over theplace," MacKenzie said. n
-- Steve Sternberg Special to BioWorld Today
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