Posted: Wednesday, October 24, 2012 9:37 AM
The USDA has told several biotech developers in the past year that their genetically engineered crops are not subject to the agency's regulatory authority.
Regulated biotech crops are overseen by the agency's Animal and Plant Health Inspection Service, which can deregulate them after conducting an environmental review.
However, some universities, private companies and USDA researchers have requested clarification from the agency whether their crops should be subject to this regime.
The agency's responses indicate that APHIS generally doesn't think the genetically engineered organisms in question fall under its jurisdiction as long as they're not plant pests.
However, the agency has said they may still be subject to the authority of the U.S. Environmental Protection Agency or the Food and Drug Administration.
* In September, the agency responded to a letter from BioGlow LLC determining that the company's crop was not a plant pest and wasn't regulated. Information about the plant and trait was redacted.
* In June, the agency informed the University of Nebraska that a sorghum altered with a transgene that is subsequently removed through breeding wouldn't be regulated.
* In May, APHIS told the Scotts Co. that a variety of St. Augustine grass wouldn't be a regulated article because it included genetic material from plant species, not plant pests.
In a separate letter that month, the agency issued the same determination for a Kentucky bluegrass variety that included genetic material from various other plants.
* In April, APHIS said that a transgenic switchgrass variety developed by Ceres, Inc. for higher yields wasn't a regulated article because the organisms used to create it weren't plant pests.
* That same month, the agency told the University of Florida its genetically engineered grapevine -- which uses genes from other grapevines -- would not be subject to regulation.
* In March, APHIS confirmed that Dow AgroScience's "zinc-finger" technology, which can delete genes, doesn't come from a plant pest and thus wouldn't be regulated.
Last year, the agency issued similar guidance to several companies. In some responses, APHIS said the technology would be regulated or would have to be evaluated on a case-by-case basis.
The Center for Food Safety, a non-profit group that is critical of APHIS, believes the determinations are typical of the agency's "seat of the pants" regulation of biotech crops, said Andrew Kimbrell, its executive director.
"They are a rogue agency at this point," said Kimbrell. "We don't have enough transparency to know what is slipping through the cracks."
Kimbrell said the agency's position in its responses seems in line with its approach to regulated crops -- APHIS doesn't think it can regulate any crops that aren't plant pest risks.
That stance will soon be legally tested before the 9th U.S. Circuit Court of Appeals, which is reviewing a lawsuit that hinges on that question, he said. "We'll see how far that authority extends."