WASHINGTON (AP) - Biotech companies would be required to consult with the government before selling new genetically engineered foods or ingredients, under industry-backed rules proposed Wednesday by the Food and Drug Administration.
Companies now are not required to have the FDA review new biotech crops, although most do so voluntarily. The FDA also issued voluntary guidelines Wednesday for food companies to follow if they label foods as biotech-free or promote biotech ingredients.
Companies would be required to notify FDA of new biotech products at least four months before they are to be put on the market. Scientific descriptions of the new products, such as genetically modified wheat, would be posted on the Internet during the agency's review.
The rules address "what is of most concern to consumers, that is making our process more open and transparent and making it mandatory," said FDA Administrator Jane Henney.
The new rules are in line with a series of proposals that the Clinton administration made this spring to respond to criticism of its regulation of the biotechnology industry. Consumer advocates and environmentalists say federal regulation of the industry is lax and have called for mandatory labeling of all biotech foods.
Under a policy developed during the previous Bush administration, the FDA considers gene-altered crops to be essentially the same as those produced by conventional breeding methods and thus not subject to the same regulatory controls as food additives. A federal judge upheld the policy last fall.
Genetic engineering in agriculture involves splicing a gene from one organism, such as a bacterium, into a plant or animal to confer certain traits, such as drought tolerance or insect resistance in the case of plants.
Genetically engineered varieties of soybeans and corn became popular with farmers in the late 1990s and are found in products throughout supermarkets. Monsanto Co. has created a herbicide-resistant wheat that is expected to come on the market as early as 2003. Biotech varieties of fruit, vegetables, fish and livestock are in various stages of development.
Biotech and food companies, hoping to head off more stringent regulation, had asked for the new review policy and labeling guidelines. The companies say further regulation is unnecessary and are concerned that mandatory labeling of gene-altered products could raise unnecessary public fears about the foods and strangle the industry.
"The increased openness and accountability that will flow from the changes FDA announced today provide renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety," said Carl Feldbaum, president of the Biotechnology Industry Organization.
The industry has been on the defensive in recent months because of nationwide recalls of taco shells that were found to contain a variety of gene-altered corn that hasn't been approved for human consumption.
There are unresolved questions about whether the StarLink corn could cause allergic reactions. It is the only biotech crop not allowed in food. Federal officials say they shouldn't have allowed the corn to be grown without approving its use in food.
Biotechnology Industry Organization: http://www.bio.org
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Last Updated on 1/17/01