USDA plans to outsource biotech studies

The USDA plans to experiment with a new way of evaluating biotech crops for potential commercialization.

Under the agency's new two-year pilot project, biotech developers would conduct their own environmental assessment of transgenic crops or pay contractors to perform the analysis.

Currently, officials at USDA's Animal and Plant Health Inspection Service are responsible for the studies.

Federal environmental law requires the agency to complete such reviews before deregulating biotech crops.

The goal of the new pilot program is to make the process more timely and efficient, according to APHIS.

The approach has met with support from the biotech industry, which wants to reduce delays in the approval of transgenic crops.

Critics of genetic engineering, on the other hand, worry the program will result in biased and inaccurate environmental reviews.

Officials from APHIS can ask for the studies to be revised and will still be in charge of deciding whether to deregulate a crop, said David Reinhold, the agency's assistant director for environmental risk analysis programs.

"We're going to do that no matter who develops the document," he said.

Because agency employees won't have to write the actual studies, they'll be able to spend more time and energy reviewing them, Reinhold said.
For biotech developers that prefer to hire a contractor to conduct a study, APHIS would choose the environmental consultant from a government-approved list.

"It's going to be a specialized company that can do agriculture and (genetic engineering) issues," he said.

Currently, the agency has a backlog of more than 20 crops awaiting a decision on deregulation, said Karen Batra of the Biotechnology Industry Organization.

The pilot program will not only help move crops through the process more quickly, but the added resources will also help the documents hold up in court, she said.

"A big deterrent to future lawsuits would be if USDA were to win some of them," Batra said. "The more information the department has, the better case they can make."

In recent years, biotech opponents have won lawsuits claiming the agency violated environmental law by inadequately supporting its decision to deregulate transgenic alfalfa and sugar beets.

"The bottom line is we're looking for an approach that makes the USDA more timely in its decision making and improve their legal defensibility," Batra said.

By allowing biotech developers to conduct their own environmental assessments, the process becomes subject to conflicts of interest, said Bill Freese, science policy analyst for the Center For Food Safety and a biotech opponent.

"It's like asking BP to write an assessment of an offshore drilling operation," he said.

The pilot program basically treats the environmental review process as a "rubber stamp" for getting biotech crops to market more quickly, Freese said.

Thoroughness should be a higher priority than timeliness, he said. "Our emphasis is on quality."

As for the prospect of contractors writing the documents, the arrangement would reduce the ability of Center for Food Safety and other groups to weigh in on the process, Freese said.

"It's one step removed from public feedback," he said.