Lisa Dry, spokeswoman for the Biotechnology Industry Organization, said companies are working with regulators to do all they can to make sure biopharming remains safe. The new report, she said, ignores the potential benefits of biopharming and the reason why new techniques are needed to develop drugs. "The conventional methods just don't meet the demand," she said.
Jaffe's organizations has long pushed for more transparency in what it sees as an opaque process for approving permits. Yesterday, the USDA said it will announce revised rules later this month that will give the public greater access to information about exactly what crops biotechnology companies are planting and how great a risk they pose.
"We believe in being transparent, and that's why we are working on our rules," said Cindy Smith, the USDA administrator who oversees regulation of biopharming.
Smith said the USDA hopes to address one of Jaffe's central criticisms by working with the Food and Drug Administration to assess the effects on humans if a gene-altered plant were to slip into the food supply. That new policy has not been finalized, however, and she said it could take several years to implement.
Scientists believe that most pharmaceutical and industrial proteins are easily digestible and are not likely to harm people, even if they're eaten in large quantities. Still, because the exact impact of any individual protein is not known, if gene-altered plants were to become mingled with ordinary crops, it could spur a massive recall.
That possibility concerns the Grocery Manufacturers of America, which represents the food and beverage industry.
"We need a comprehensive regulatory system that ensures everyone knows who is responsible for what when the products are being developed. Right now we have a piecemeal system," said Stephanie Childs, a Grocery Manufacturers of America spokeswoman.
But ProdiGene chief executive John Reiher said the USDA has already enacted a robust set of rules that allow for no margin for error. The USDA tightened its rules in March 2003, just four months after ProdiGene's mishandling of its gene-altered corn became public.
Under the revised rules, the USDA mandated extended buffer zones between ordinary crops and their gene-altered cousins, more stringent harvesting procedures and better training for farmers and biotechnology company employees involved in growing the crops. The USDA also said that biopharm companies could expect seven times more inspections by federal regulators.
"USDA has expanded its regulatory requirements since the ProdiGene incident. . . . [The new rules] would prevent a similar situation from happening again," said Reiher, whose company has three applications pending to grow gene-altered corn in Texas.
Reiher said ProdiGene is in full compliance with the new regulations, and in some cases exceeds the requirements. For instance, the new rules dictate that gene-altered corn can't be grown within a mile of ordinary corn. Reiher said his company's corn is kept two or three miles away from any corn that winds up on consumers' plates.
Scott E. Deeter, president and chief executive of California-based Ventria Bioscience, said technology and economics often don't allow for the use of crops other than food when it comes to biopharming. His company, he said, has applied to use rice and barley to develop products that could improve human health.
"We wouldn't be able to bring these benefits to society if we were relegated to a non-food system," he said.
