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Ag Biotech Advice Sends Mixed Signals to Regulatory Officials

The Clinton administration vowed to "secure the bright future" of agricultural biotechnology in May when it announced regulatory initiatives aimed at building consumer confidence in this sector while keeping federal biotechnology rules in line with scientific and market developments. However, in deciding not to introduce mandatory labeling—a change that many critics of the technology insist is needed—the administration has managed to please many scientists and representatives of the industry but may not have quelled the controversy (ASM News, June 2000, p. 333). Amid this continuing debate, yet another advisory body—the Standing Committee on Biotechnology, Food and Fiber Production, and the Environment, organized by the National Academy of Sciences (NAS) at the request of Secretary of Agriculture Dan Glickman—began rummaging through many of these same issues to determine what, if anything, might need fixing.

FDA Provides Forum for Biotech Food Policy Proponents, Critics 

The most controversial component of the administration’s initiative revolves around decisions by Commissioner Jane Henney and other officials of the Food and Drug Administration (FDA). Late in 1999, they held a series of three public meetings to learn more about public concerns over bioengineered food products. Although many who spoke at those meetings pleaded for mandatory labeling of biotechnology-derived foods, others did not (ASM News, February 2000, p. 62).

Now FDA officials have concluded that biotech foods do not require labels but that previously voluntary consultations between the agency and industry over new food products henceforth will be mandatory. To determine the appropriate messages to convey in those anticipated voluntary labels, agency officials are planning to use focus groups and to seek other input from consumers and industry.

The FDA decision immediately prompted both support and criticism. "The biotechnology industry supports the FDA decision to make the approval process for foods improved through biotechnology more transparent," says Carl Feldbaum, President of the Biotechnology Industry Organization (BIO) in Washington, D.C. "We did not think this step was necessary…But if the steps…serve to further strengthen public confidence in the United States’ already strict regulatory system and the safety of our food supply, then they must be considered appropriate and positive."

However, others are strongly criticizing the FDA decision to retain its voluntary labeling policy. "Labeling is absolutely essential for GE crops," says Katherine DiMatteo, executive director of the Organic Trade Association, also in Washington, D.C. "If the technology is legitimate and not to be feared, it needs to be labeled," she says about biotechnology.

Several members of Congress, particularly Senator Barbara Boxer (D-Calif.) and Representative Dennis Kucinich (D-Ohio), who submitted similar bills to make labeling of biotech foods mandatory, also fault the FDA decision to keep such labeling voluntary.

Meanwhile, the administration initiatives also call for other changes involving the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) as well as FDA. It recommends that USDA seek input from consumers, industry, and scientists on "how best to meet the needs of evolving markets." In addition, those three agencies plus the State Department are being asked to "enhance domestic and foreign public education and outreach activities" to improve understanding of the nature and strength of the U.S. regulatory process. In addition, there will be a six-month interagency review of the full array of federal regulations pertaining to agricultural biotechnology.

One issue certain to be raised during that review—how to regulate transgenic salmon or other fish that are engineered with growth hormone genes—came up during the NAS new standing committee’s first public meeting in May. Several federal agencies with seeming interest in such fish, including USDA, EPA, and FDA, have limited regulatory jurisdiction over them, particularly if they were to escape fish pens and threaten their wild relatives, whose survival already is in doubt in the case of several species of salmon. On this issue, at least, there are "cracks in our regulatory framework," says William Brown, science advisor to Bruce Babbitt, who heads the Department of Interior. Arguing that the Interior Department should be involved in such reviews, he says, "We may need new authorities from Congress."

Jeffrey L. Fox