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To some, it seemed inevitable. First, bioengineered corn unapproved for human consumption was discovered in taco shells in the United States. Then it showed up in U.S. corn shipments to Japan. And for more than a week, millions of bushels of high-tech corn went unaccounted for. Who’s at fault? No one — at least no one government agency. Regulation of biotech foods is spread among three federal agencies, leading to a system of oversight that critics say is too thin and disorganized to keep pace effectively with the rapidly changing field. “The regulatory system is so fragmented and full of holes and inconsistencies that it’s a stretch to call it a system,” says Jean Halloran, director of the Consumer Policy Institute at Consumers Union. “There is a lot of smoke and mirrors to suggest there is real review when there isn’t.” Some on Capitol Hill have taken notice. “It’s very clear that the emergence of biotechnology has brought about a whole new set of regulatory challenges which the current regulatory structure is not able to handle,” says Rep. Dennis Kucinich, D-Ohio. “In the next session of Congress, there is going to be a push for labeling, for safety testing, and potentially for some revision of the agencies’ responsibilities.” But the industry says that a full-scale revamping of the system is unnecessary. The StarLink corn mishap was not the result of a fragmented regulatory system, industry representatives say. Instead, they argue, the Environmental Protection Agency made a single regulatory error in ever allowing the tainted corn to be used for animal feed. It was thus almost inevitable that some of the StarLink corn would be inadvertently mixed in with corn meant for human consumption. “With today’s food supply, it’s unreasonable to think you can prevent co-mingling,” says Gene Grabowski, vice president of communications for the Grocery Manufacturers of America. “No more partial approvals. That was a mistake, and we’ve all learned from this particular case.” The industry finds the call for a major overhaul premature, given that its data show that no one has been harmed by consuming biotech foods. “I know some members of Congress want more regulation. But let’s try and keep things in perspective,” says Val Giddings of the Biotechnology Industry Organization (BIO). “Hundreds of millions of people around the world have been consuming foods engineered through biotechnology, and to date there hasn’t been a single cold or sniffle associated with that. These foods are safe.” A LEGISLATIVE HISTORY This is not a new debate. During the past two decades, some members of Congress have tried to resolve the issue of regulating the genetic engineering field. A young Rep. Albert Gore Jr., D-Tenn., made it one of his pet issues in Congress. But the wide-ranging biotech bills that were proposed never made it through Congress. While legislative efforts were failing, genetically modified products — including food, animals, and medicines — were being developed, and something had to be done. Under both the Reagan and the Bush administrations, three agencies — the EPA, the Department of Agriculture, and the Food and Drug Administration — developed their own internal policies and regulations to get biotech food through the federal government and onto the open market. Much of that involved fitting the genetically modified products under already existing laws and regulations. And that is why each agency looks at certain slices of the biotech market. The Department of Agriculture regulates the testing of new biotech plants. Before companies are able to commercially grow new genetically engineered soybeans or wheat, Agriculture has to review what the plant is and how its growth may potentially impact the environment. The EPA has oversight over all pesticides and, by extension, all of those genetically engineered plants that are cross-bred or created to produce pesticides. The agency has to sign off on the safety of the pesticide-producing plant for consumption. The FDA is in charge, generally, of all food products for human and animal consumption — except meat and poultry, which come under Agriculture’s purview. In 1992, while the Bush administration was in the throes of its regulatory rollback program, the agency concluded that genetically modified foods were substantially the same and as safe as any other food and would be regulated similarly. Exceptions were made for genetically modified foods that could trigger allergic reactions. And companies were strongly encouraged to go through a voluntary consultation process before putting genetically modified foods on the market. “The federal government has had an interlocking regulatory structure for food since 1910,” says former FDA chief counsel Peter Barton Hutt, a partner at D.C.’s Covington & Burling who represents many major food and drug interests. “The fact is that different agencies deal with different aspects. That is not a problem. You don’t want a czar of every issue.” Enter StarLink. Aventis CropScience put the genetically engineered corn, which internally produces a pesticide, through the Agriculture Department review process, which it passed. The company also put the product through the EPA pesticide review and consulted with the FDA about its safety. But because Starlink produces a pesticide, the FDA and the EPA split oversight of it. The EPA looked at the pesticide product it produced, and although it approved StarLink for animal feed, the agency had a few unresolved concerns about potential allergic reactions to the pesticide among humans. The EPA was still reviewing that issue when the contaminated taco shells were discovered. Although there has been no evidence that eating StarLink corn causes harm or allergic reaction, there just has not been enough evidence to satisfy the EPA that it would not. When the FDA reviewed StarLink during the voluntary consultation, it only looked at the corn part of the product, not at the pesticide that the corn produced. The FDA does not give a formal approval to products, but the review is listed on the agency’s Web site as having been completed in 1998. WHAT NOW? So the questions still remain in the StarLink case: What went wrong, and how can government overseers keep it from happening again? In the industry’s eyes, the furor over StarLink is corrective in itself: Neither the EPA nor any company will want to repeat the product recalls and plant closings that StarLink has caused. Although the EPA has not said anything about changing its policy, industry experts predict that the so-called partial approvals, which put into the marketplace products approved for animal use but not human use, are likely a thing of the past for genetically modified food. “Both the agency and Aventis erred in getting the partial approval,” says Giddings of BIO. “I promise you this — no one will ever again go through with a request for or acceptance of a split approval for grains or bulk commodities.” But the environmentalists and consumer groups say that in the StarLink case some of their warnings about genetically modified food have come true — and serious overhaul is needed to change the system. “This regulatory tangle is in no one’s interests,” says Andrew Kimbrell, executive director of the Center for Food Safety. “We are going to have to show the regulators that the system we have is broken and you can’t fix it. We are locked in until Congress comes up with some kind of inspirational leadership. I see no relief in this from an agency-by-agency battle of fixes.” Most of the environmental groups are pushing for a combination of labeling and regulation. In the past two years they have found some sympathetic lawmakers, including Kucinich and Sens. Barbara Boxer, D-Calif., Daniel Patrick Moynihan, D-N.Y., and Richard Durbin, D-Ill., among others, who have all put bills forward. Earlier this year, the Clinton administration said it was moving toward a regulation that would make FDA consultations for biotech foods mandatory and would allow voluntary labeling. The FDA is expected to put out a draft version of that proposal before the end of the year. But the Clinton administration proposal does not appear to go beyond what the industry supports. All of the genetically modified foods on the market have gone through the voluntary consultation, so making it mandatory is not likely to provide broader oversight. The environmental groups don’t think much of the proposal. And if the StarLink fallout lingers to next year, there may be a push to take a much more comprehensive look at how the regulatory structure works. “It just doesn’t make sense — the FDA is looking at food, and the EPA is looking at certain seeds, and the USDA is looking at other aspects of genetically modified food,” says a Durbin staffer. “Our long-term goal is that we will have one agency that will look at all of this. With a new administration, maybe we will be able to get somewhere on that.”

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