Consumer groups have won the latest round in their battle to keep a California biotechnology company from planting genetically engineered rice that would potentially produce human pharmaceuticals, as regulatory authorities sent the firm's proposal back to a committee for further review.

The California Department of Food and Agriculture (CDFA) on Friday (April 9) rejected Sacramento-based Ventria Biosciences' application to grow 120 acres of the genetically engineered rice in southern California because the firm had not received approval from federal regulators. The department sent the proposed regulation back to the California Rice Commission, which makes recommendations to CDFA, for further review.

The decision on whether the CDFA should permit the company to go ahead with its plans to plant the rice will likely face a 60- to 90-day public comment period. In addition to consumer and environmental groups, farmers and trade groups representing food processors are expected to weigh in on the issue.

A Ventria representative told The Scientist on Tuesday (April 13) that no one was available to comment. However, according to the Associated Press, the firm said that it would reapply to California authorities despite the recent setback.

CDFA's decision came less than 2 weeks after the commission approved by a 6-to-5 vote the firm's proposal to grow rice genetically engineered with human genes to produce lactoferrin and lysozyme. Both proteins are found in bodily secretions such as milk, tears, and saliva, and possess antibiotic, antifungal, and antiviral properties.

Although Ventria has touted the potential benefits of using rice to develop such drugs, consumer groups and environmental activists have raised concerns about the possible effects on the environment and human health. Michael Hansen, an ecologist and senior research associate at Consumers Union's Consumer Policy Institute in Yonkers, NY, cited concerns such as public exposure to drugs produced in the rice, the triggering of food allergies, and a potential negative impact on beneficial microbes in the environment.

“There are unanswered environmental and human health issues” regarding the two proteins, Hansen told The Scientist. While Ventria is taking steps to reduce the potential of other crops being contaminated by the genetically modified rice, he said, “errors are inevitable. The physical and biological mechanisms for containment are not 100%.”

Ventria had sought approval from CDFA via an emergency proposal, which would have enabled the firm to plant during this year's April to July season. But critics argued that no emergency existed and urged the department to reject the proposal.

Even without the concerns raised by critics, CDFA was unlikely to permit Ventria to begin planting this month after the US Department of Agriculture (USDA) pointed out that the firm lacked the necessary federal approval to expand its operations in southern California.

Rebecca Spector, of the environmental advocacy group the Center for Food Safety (CFS), said in an interview with The Scientist that CFS was “very pleased” with CDFA's decision. “We hope the California Rice Commission will really do due diligence and solicit comments from farmers, scientists, and the general public about the concerns about this particular pharmaceutical rice,” she said.

Spector noted that the five members of the commission that voted against Ventria's proposal were farmers. “Every farmer I've talked to is very concerned,” she said. “This has the potential to contaminate the commercial crop, and farmers are concerned about lost markets.”

In a second blow to Ventria, the USDA on Monday (April 12) decided not to renew the firm's permit to plant its genetically modified rice on a separate 120 acres in northern California, saying that it would be located too close to crops intended for human consumption. Officials from the USDA did not return calls to The Scientist seeking comment.

However, Spector noted that the USDA just closed a public comment period on their regulations for biopharmaceutical crops. “A lot of organizations are concerned about biopharmaceutical crops and are hoping that the USDA is going to establish more strict regulations,” she said.

Jeff Barach, vice president of special projects at the Washington, DC–based National Food Processors Association, said the group was concerned that there could be some loss of containment while the rice was being produced.

“There's a lot at stake. If plant-made pharmaceuticals, proteins, monoclonal antibodies, viruses, vaccines, whatever they are producing, wind up in the food supply, then that food is adulterated, and we'd have to go through recalls and there could be potential consumer harm, loss of brand name, and large amounts of dollars spent on recalling products,” Barach said. “So we are setting a high bar.”