FDA Public Hearing On Biotechnology

Article originally published in November, 1999

On November 18th, the FDA held the first of a series of three public hearings on the use of modern biotechnology, specifically, on the use of recombinant DNA techniques, on food products. The hearing had two panel sessions, the first on scientific, safety and regulatory issues, the second on labeling. It ended with a number of two-minute comments by members of the public.

Current regulations require premarket approval from the FDA only if the product contains a substance that is not generally recognized as safe (GRAS), no matter the process by which the product is made. To date, the FDA has found that all of the substances added to food products via rDNA are GRAS, and so developers have not been required to submit their modified food products for premarket approval. However, to date, all developers have participated in a voluntary consultation process with the FDA prior to marketing. In the first panel session, all of the panelists except for the Greenpeace representative agreed that the consultation process worked well to assure the safety of biotech food products, but there was substantial disagreement about whether the consultation process should be made mandatory. Some felt that making it mandatory would promote much needed public confidence in the review process. Dr. Marion Nestle, Professor and Chair of the Department of Nutrition and Food Studies at New York University, said that numerous consumer surveys by industry groups, consumer groups, and academic institutions had uniformly indicated that there is substantial distrust of the food biotech industry to act in the public interest as well as distrust of the government to adequately oversee the biotech industry. (One comment to the contrary made by Lisa Katic, Director of Scientific and Nutrition Policy for Grocery Manufacturers of America, that GMA surveys had shown that "consumers have absolute confidence in the industry," received a good laugh from the audience.) Surprisingly, none of the representatives from the biotech industry on the panel stated any objections to making the consultation process mandatory. They satisfied themselves with expressing the view that the consultation process was already de facto mandatory in that no firm would risk marketing a rDNA modified food product without prior FDA input, and that the current, voluntary system was adequate. All of the panelists agreed that the review process should be made more transparent, and that the FDA should be doing more to inform the public of the safety testing being done.

With regard to labeling, the panel was divided on whether it should be required on all foods containing more than trace amounts of rDNA modified ingredients or, as is the practice now, only on those foods that differ substantially from their conventional counterparts in terms of safety or nutrition. Some panelists believed that the broader label requirement would be misleading, suggesting to consumers that the product was less nutritious or more harmful than its conventional counterpart. Others thought that a label which stated "This food contains rDNA modified ingredients" was no more misleading than other labels currently allowed, and believed that both overcoming public distrust and expressing appropriate sensitivity to people's ethical and religious objections to rDNA food products required the broader labeling requirement.

Many other aspects of this two issues were debates. For more extensive notes, check my web site at http://philosophy.wisc.edu/streiffer Those interested in having their comments recorded in the federal docket can do so at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

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Writer: Robert Streiffer (608) 262-7490 ; rstreiffer@facstaff.wisc.edu