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Biotech regulation falls short, says Pew report

(Thursday, April 1, 2004 -- CropChoice news) -- Justin Gillis, Washington Post: Federal regulation of the increasingly exotic products of the biotechnology industry may soon be inadequate to assure the public the products are safe, according to a new report.

Opinion in Washington is sharply divided on whether the 18-year-old biotech regulatory system can be fixed with administrative tweaking or whether Congress needs to pass new laws, said the report by the Pew Initiative on Food and Biotechnology, a think tank. But either way, the report cites numerous examples to make the case that action by the federal government is needed to ensure credible oversight of an industry that is tinkering with the very foundations of life.

"The regulatory system isn't broken, but it is showing signs of wear and tear," said Michael Rodemeyer, executive director of the Pew Initiative, which has taken a centrist position in weighing the risks and benefits of agricultural biotechnology.

The need for fixes is likely to grow pressing as the industry develops gene-altered fish and insects, farm animals that produce human drugs in their milk, and plants that make drugs or industrial compounds in their leaves and seeds, he added. A handful of these products are already in the late stages of development, but for many of them, federal agencies have produced no final guidance on how -- or even whether -- they will be regulated.

The Pew report, to be formally released today, is the most detailed analysis in years of a plan devised during the Reagan administration to oversee the new crops scientists were designing in their laboratories. The heart of that plan was to reinterpret existing laws, some of them passed decades earlier, to apply to the new technology. The result was a patchwork regulatory system that split jurisdiction among three agencies, all using different laws and standards.

The crops commercialized under that system have included corn, soybeans, cotton and other plants into which new genes have been inserted to confer better resistance to weeds and insects. Americans have been eating such foods for nearly a decade, but polls show most don't know it. Europeans have been more aware -- and more skeptical -- of the crops, with European politicians repeatedly citing the perception that the U.S. regulatory system is weak to oppose the technology in their own countries.

While maintaining that the current crops are safe to eat, biotechnology and food companies have feared a repeat of the controversy as new biotech animals near commercialization. That is one reason the industry is among those pressing for clearer regulations.

One proposal for tighter regulation of biotech crops was endorsed several years ago by virtually every group with a stake in the issue: the biotech industry, the food industry, environmentalists and consumer groups. The proposal was nearing approval as the Clinton administration left office, but the Bush administration has not acted on it.

Thomas Hoban, a sociologist and food scientist at North Carolina State University who has followed public opinion on biotech issues for years, said he visited the Food and Drug Administration last week to brief lower-level staff members. He described polls showing rising public unease with agricultural biotechnology. The staffers, mostly scientists, "were livid" that the Clinton-era proposal had languished, he said. "The scientists are saying, 'We need it,' " Hoban said.

Forthcoming products, ranging from a salmon designed to grow twice as quickly as normal to plants designed to act as medicines, are likely to pose tricky new issues of safety and public confidence, but the FDA has been slow to clarify how it will regulate some of these products, he said. "I want a much, much stronger FDA on this, as do most consumers," Hoban said.

Several people in Washington trade groups, speaking on condition that they not be identified because they need to maintain good relations with the FDA, said the process of creating new rules had been bogged down by disagreement between some of the scientists in the agency and the FDA's general counsel, Daniel E. Troy. Troy is said to be more cautious about expanding the FDA's authority to regulate various products.

Before joining the Bush administration, Troy was a lawyer who sometimes represented tobacco and pharmaceutical companies in disputes with the FDA. He declined requests for an interview through an agency spokesman. The spokesman, Brad Stone, issued a statement saying "the agency and the administration are carefully weighing the public health, scientific and legal ramifications of this technology." The statement said this review would necessarily take time, but it added that "the agency is prepared to take any appropriate measures necessary to protect the public health."

Indeed, it is clear that the Bush administration is well aware of many of the looming issues, and the White House science office is leading discussions aimed at clarifying government regulations.

Perhaps the biggest dispute now is how to regulate genetically engineered animals, such as fish meant for human consumption and farm animals genetically altered to produce human drugs in their milk.

Two plans have been widely discussed in Washington. One would create a system of voluntary consultations between the FDA and the biotech industry. That plan, similar to the approach the FDA takes now for biotech crops, enjoys little support among industry, consumer or environmental groups, but it is something the FDA clearly has legal authority to do. A stricter plan, favored by virtually all groups, would regulate the animals under a statute originally designed for new animal drugs, and would involve detailed, mandatory reviews of food safety. But it would also require a creative interpretation of the laws governing the FDA.

The Pew report said it's not clear that even the stricter approach would provide for an adequate review of environmental questions involving gene-altered animals, one reason some groups want Congress to pass a new biotech law.

Source: http://www.washingtonpost.com/wp-dyn/articles/A40595-2004Mar31.html