A battle is brewing between university researchers and the biotech seed industry over the development of genetically modified (GM) crops. In a letter to the U.S. Environmental Protection Agency (EPA) earlier this year, 26 public sector entomologists complained that crop developers are curbing their rights to study commercial biotech crops. At a July meeting organized by the American Seed Trade Association in Alexandria, VA, representatives from leading seed companies met with the entomologists and developed a set of principles to conduct such research. However, the seed companies are not obligated to follow the guidelines, and the industry’s reluctance to share its products with scientists is fueling the view that companies have something to hide.
Commercial entities have developed nearly all of the GM crops on the U.S. market, and their ownership of the proprietary technology allows them to decide who studies the crops and how. “Industry is completely driving the bus,” says Christian Krupke, an entomologist at Purdue University. Company control starts with a simple grower’s contract. Anyone who buys transgenic seeds must sign a technology stewardship agreement that prevents the buyer from conducting research on the seed or supplying it to a researcher. Thus, scientists can’t simply buy seeds for their studies, and farmers can’t slip them some on the side. “You need permission from industry, and you have to specify what you want to do with the plants,” says Bruce Tabashnik, an entomologist at the University of Arizona in Tucson. Seed companies can refuse a research request for any reason. Some may be isolated instances; others result from company policies. Even the notion of seeking permission from companies to conduct studies is a deterrent. “There are three strategies that [scientists] take,” says Elson Shields, an entomologist at Cornell University. “Some are just not doing the research. Some are changing their experimental protocols so that they are acceptable to industry, which may or may not be a good thing. And some are just going out and buying the seeds and doing the research in violation of the technology agreements.”
When requesting permission, scientists usually must describe in detail the design of their experiment, which provides companies with a head start in preparing a rebuttal. Once a company and scientist agree on the study design, they still must negotiate the terms of the research agreement. Negotiations often break down because companies want to limit or control publication of the study. “When you are funded by state and federal dollars, you have an obligation that the research you conduct is public and published,” says Beverly Durgan, dean of extension services at the University of Minnesota. “Signing research secrecy agreements is something we really can’t do.” Several major seed companies say they have negotiated multiyear agreements with major universities that give scientists the freedom to conduct and publish most agronomic research without requesting permission for every study. In fact, seed companies frequently pay academics to study precommercial products, similar to consulting arrangements or discovery work carried out for big pharmas. The companies say they have to keep tabs on public sector research to ensure the studies are done with good stewardship practices and in accordance with regulations, since they could be liable if an adverse event occurred with a precommercial product — even under the watch of a public sector scientist. Companies also say they must ensure that products that haven’t received approval for export to certain countries aren’t shipped there. And, since they want to protect their IP, they’re particularly averse to allowing the public sector to breed crops or to characterize the genetic composition of a GM plant, which can cost up to $100 million to develop.
In some instances, university scientists have raised concerns about data submitted to regulatory agencies, but they’ve had no recourse once the crops were commercialized. In 2001, for example, Johnston, IA-based Pioneer HiBred was developing a transgenic corn variety that contained a binary toxin to fend off rootworms. The company asked some university laboratories to test for unintended effects on a lady beetle. The laboratories found that nearly 100% of lady beetles that had been fed the crop died after the eighth day in the life cycle. When the researchers presented their results to Pioneer, the company forbade them to publicize the data. Two years later, Pioneer received regulatory approval for an anti-rootworm corn variety with the same toxin, but the data submitted to the EPA indicated no sign of potential harm to lady beetles. “If there’s a sense that a problem is being swept under the carpet, that only fuels the fear,” Tabashnik says. “It’s better to be open about it. It’s not as if one problem with one variety means the whole technology isn’t useful.”
Source: PuppetGov