The Hawaiian Islands were less than a paradise for two Midwestern seed companies this summer. Following a routine EPA inspection in March, Pioneer Hi-Bred International, Inc., and Mycogen Seeds, a unit of Dow AgroSciences, LLC, had to explain why test plots for their experimental Bt corn products didn't match their Experimental Use Permits (EUPs).
In both cases, the companies alleged errors were technical oversights. Unlike the ProdiGene problem last fall, there was no contamination of commercial crops. And, while both companies paid fines, the assessments were less than $10,000 in each case.
The ProdiGene case involved biotech corn designed to produce plant-made pharmaceuticals (PMPs), a class of products that will never be labeled for food and feed use.
On the other hand, Pioneer and Dow AgroSciences were both testing a Bt event for rootworm resistance. The plant-incorporated protectant (PIP) crops, like Bt, did not have feed and food approval for the experimental plots but will before they receive registration for commercial use.
According to EPA, Dow AgroSciences didn't have the appropriate tree buffer around its experimental field and failed to use hybrid corn varieties as a buffer crop to ensure pollen containment. In Pioneer's case, EPA ruled that the company planted its experimental corn in an unapproved location that was within 1,260' of other Pioneer seed production corn.
“These are the first two cases we've had concerning biotech EUPs. The EUPs had very stringent requirements that were very specific to assure containment,” says Amy Miller, EPA Enforcement Team leader for Region 9, which includes the Hawaiian Islands. Only three EUPs for biotech corn were issued for 2002. Pioneer, Mycogen and Monsanto applied for and received permits for those EUPs.
In both the Pioneer and Mycogen cases, the companies maintain that the alleged violations occurred due to misunderstandings rather than deliberate disregard for their EUPs.
“In our case, it was a difference of opinion on the interpretation of the EUP. We believe we followed the regulations,” says Courtney Chabot-Dreyer, Pioneer public relations manager. “We support a rigorous regulatory system. In the future we'll spend much more time discussing key terms and the supporting information required with EPA.”
Says Garry Hamlin, Dow AgroSciences spokesperson: “It's appropriate for us to step forward and say we didn't do what we said we would. We thought the deviation we made actually improved pollen containment. It's an important message. A permit is exactly what it says it is and you need to adhere to the constraints.”
He adds, “We've done a root cause investigation to find out why these events occurred. We've added to our program to clarify responsibilities and the documenting process.”
The Biotechnology Industry Organization (BIO) takes a clear stand on compliance with biotech products. “There is no excuse for infractions. Compliance has to be a high priority,” says Lisa Dry, BIO communications manager. “We can't make apologies. Compliance is part of our obligation to maintain access to the technology.”
That access is being challenged by groups that oppose genetically modified crops in general. Following the ProdiGene debacle last fall, a group named the Genetically Engineered Food Alert called for an indefinite moratorium on “biopharm” crops.
“We have to maintain the confidence of our end users. And every time there's an incident, it makes the public that much more sensitive to the issue,” says Leon Corzine, chairman of the NCGA Biotechnology Working Group. “We need to work to make sure there is a distinction made among corn products. And we must be sure the integrity of commodity corn and its markets is protected. The good news is it shows that the regulatory system works.”