The U.S. Department of Agriculture plans to start outsourcing research used in the review of new plant seeds to outside consultants and biotech companies seeking government approval.
The pilot program comes as the seed industry complains the agency is taking too long to approve new products it says are needed at a time of surging crop prices and growing world food demand. Opponents of genetically modified crops, however, contend the USDA shouldn't be looking to streamline a process that already isn't doing enough to detect possible dangers.
Under the two-year pilot, companies would agree to pay for a third-party contractor, chosen by the USDA's Animal and Plant Health Inspection Service, to conduct an environmental assessment of new products they want to commercialize. Companies also have the option of submitting their own research, which the USDA would use in developing its own assessment.
"This is very similar to what is done in a number of other agencies that have regulatory responsibility," said U.S. Agriculture Secretary Tom Vilsack in a recent interview.
Biotech companies spend heavily on developing new seeds that can yield larger crops by making a plant resistant to a specific pest or tolerant of a certain herbicide. Before going to market, the USDA reviews a product to ensure it won't itself become a problem that potentially contaminates other fields or causes additional environmental problems. The U.S. Food and Drug Administration and U.S. Environmental Protection Agency also look at issues surrounding new seed proposals.
The USDA pilot program could speed up the review of genetically modified crops. It now takes seeds nearly seven times as long to win federal approval than it did when the first product was introduced in 1996, said Karen Batra, spokeswoman for the Biotechnology Industry Organization, a trade group that includes companies such as DuPont Co. (DD), Syngenta AG (SYT) and Monsanto Co. ( MON), as well as academic institutions.
"Right now we've got 20-some products that are in the queue, waiting to be looked at," she said. "Some of these have been there for years."
Yet opponents of genetically modified crops feel not enough work is being done to protect the public. The issue for the USDA should not be the time it takes to assess a proposed new crop, but the quality of that review, said Bill Freese, science-policy analyst for The Center For Food Safety, a nonprofit environmental group critical of genetically modified products.
A large biotech company, which has already spent many millions of dollars to develop a genetically modified seed, isn't likely to provide environmental information that threatens its chance for commercialization, Freese said.
"It's another sign that (USDA) views this whole process as a rubber stamp," he added.
But the pilot program does not change USDA's role in final the assessment, Vilsack said, as every product will continue to be subject to USDA review and public comment.
Vilsack emphasized that the key shift in the program is to allow private consultants to conduct environmental assessments. That step will save the USDA money and speed up the regulatory process without reducing accountability or rigor. The FDA and EPA have similar programs, he said.
The program is in part a response President Obama's request to cut 5% from the USDA's budget, he added.
Opponents of biotech seeds have gone to court where they have won rulings that temporarily barred the planting of genetically modified alfalfa and sugar beets and ordered the USDA to conduct a more thorough assessment. Freese said the agency has never rejected the proposed commercialization of a biotech seed.
Vilsack said seed companies aren't going to put all the time and money into developing a product if they don't see a strong chance for approval.
"They're only going to go through the process if they think they have a legitimate reason for asking for (the agency) to regulate," Vilsack said.
Biotech companies already spend significant time and money reviewing their products, and it makes more sense for the USDA to use that information through the pilot program rather than starting from square one, said Batra, of the industry trade group.
"What we might actually see is a little bit more of a scrupulous look by USDA because they do in fact have more manpower and more time to really do the review," she said.
Batra added the program could make USDA approvals more "legally defensible" in the event of court challenges by anti-biotech groups.
