Patent Law

Scientists Say Seed Technology Agreements Stop Research

By Stephen Albainy-Jenei

Arguing that there are too many restrictions being placed on biotech crops, 26 leading corn insect scientists working at public research institutions located in 16 corn producing states submitted a statement to the EPA. All of the scientists have been active participants of the Regional Research Projects NCCC-46 “Development, Optimization, and Delivery of Management Strategies for Corn Rootworms and Other Below-ground Insect Pests of Maize” and/or related projects with corn insect pests.

The statement may be applicable to all EPA decisions on plant incorporated protectants (PIPs), not just for the current SAP. The names of the scientists were withheld from the public docket because virtually all of them rely on cooperation from industry at some level to conduct research and they fear retaliation.

The statement:

“Technology/stewardship agreements required for the purchase of genetically modified seed explicitly prohibit research. These agreements inhibit public scientists from pursuing their mandated role on behalf of the public good unless the research is approved by industry. As a result of restricted access, no truly independent research can be legally conducted on many critical questions regarding the technology, its performance, its management implications, IRM, and its interactions with insect biology. Consequently, data flowing to an EPA Scientific Advisory Panel from the public sector is unduly limited.”

The scientists say they are going public now because of building frustration with negotiating rights with seed companies.  The problem they see is that farmers and any other buyers of genetically engineered crop seeds have to sign a technology agreement covering patent rights, environmental regulations and uses of the seeds. However, the agreements also tend to prohibit growing the crops for research purposes.  Consequently, the university scientists cannot just buy seeds and grow them for research experiments.

While the researchers can ask for permission from the seed companies, permission is sometimes denied or the company insists on the right to have an advance review of the studies’ results before they can be published.

See an example of Monsanto’s Technology/Stewardship Agreement here. A copy of Monsanto’s 60 page Technology Use Guide (TUG) 2009 is here.

Plant-incorporated protectants are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. For example, scientists can take the gene for a specific Bt pesticidal protein, and introduce the gene into the plant’s genetic material. Then the plant manufactures the pesticidal protein that controls the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA; the plant itself is not regulated.

Regulation of genetically engineered foods is divided among three federal agencies.

• USDA oversees GM crop field trials and is responsible for deregulating (i.e., permitting the unregulated cultivation of) GM crops under the Plant Protection Act (PPA).
• The Environmental Protection Agency (EPA) has jurisdiction over the pesticides incorporated in GM insect-resistant plants under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FDCA); and
• FDA conducts voluntary consultations on other aspects of GM foods with those companies that choose to consult with it, under the FDCA.

Before the EPA can register a pesticide there must be sufficient data demonstrating that it will not pose unreasonable risks to human health or the environment when used according to label directions. When assessing the potential risks of genetically engineered plant-incorporated protectants, the EPA requires extensive studies examining numerous factors, such as risks to human health, nontarget organisms and the environment, potential for gene flow, and the need for insect resistance management plans.

See New York Times article:  Crop Scientists Say Biotechnology Seed Companies Are Thwarting Research

Full post as published by Patent Baristas on February 20, 2009 (boomark / email).