Washington Editor

WASHINGTON - After two years of debating the merits of the agricultural biotechnology regulatory system, a group of industry sympathizers and their opponents were unable to decide whether future changes should be handled by Congress or the FDA.

Nevertheless, representatives from the Pew Initiative on Food and Biotechnology, a Washington-based research and education organization that facilitated the discussions, believe the talks were successful in bringing adversaries to the same table for civil discussions.

"Even though we didn't reach a complete consensus on this full range of issues, which is a very ambitious goal, we have been successful in helping to reduce polarization," Mike Rodemeyer, executive director of the Pew Initiative, told BioWorld Today.

The 18 participants, known as "stakeholders," represented the biotechnology industry; environmental and consumer groups; the farming and ranching communities; food processing and marketing companies; and academia.

Roger West, a stakeholder for the beef association, told BioWorld Today the group had "quite a bit of agreement on certain things," but was unable to decide the best way to move forward. "We couldn't get a consensus on whether to go through current regulations to get things done or through new legislation. Without that consensus, it didn't look like we had a future," he said.

West, a cattleman from Gainesville, Fla., said the beef association has an interest in the subject because "at some point in time, there will be some transgenic animals coming through the market and we want to be sure when that happens that consumers are ready to accept it."

The issue surrounding how to regulate agricultural (plant and animal) biotechnology has been controversial since the Reagan administration implemented the current policy some 20 years ago, Rodemeyer said. In part, the stakeholders were considering ways to modernize the FDA system.

"The group was looking ahead at products that are coming down the pipeline and whether there are going to be challenges and difficulties with the regulatory system in dealing with these new products with the [current] regulatory approach," he said.

For example, the FDA has a voluntary process in which food manufacturers can submit safety data and other information about a product. "Except for a food additive, a company can go to market without the FDA looking at anything ahead of time," Rodemeyer said. "Certainly, consumer groups and others have raised questions about the adequacy of that system. I'm not saying the group made judgments, but those are the kinds of issues that have made this whole area contentious."

In another example, Rodemeyer raised the issue of transgenic fish, which have been modified so they grow more quickly. "Right now the FDA has indicated that it intends to look at the environmental effects of these fish under the statute they use to approve new animal drugs," he said. "A number of people have expressed questions about the FDA's authority under that act."

So, despite its failure to get a consensus opinion, Pew did collect materials and information throughout the two-year process to use for educational purposes and conferences and other events.

The Pew Initiative is not a lobbying organization. It was established in 2001 through a grant from the Pew Charitable Trusts to the University of Richmond.