Genetically Modified Pest-Protected Plants: Science and Regulation - National Academy of Sciences
Appraisal of EPAs Assessment of the Benefits of Bt Crops - by Dr. Charles M. Benbrook for the Union of Concerned Scientists
Regulatory Process for Transgenic Crops in the US
EPA Advisors Assess Risks, Benefits of Bt Crops
Its been six years since the first biotech crops that produce their own pesticides were approved by the U.S. Environmental Protection Agency. Those crops are now set to be reapproved in September.
As this ScienCentral News video reports, while theyve yielded their share of controversy, most biotech crops are here to stay.
Genetically modified regulations
Plant-pesticides (or "plant-incorporated protectants," as they are now euphemistically called) have not only altered the way many growers protect their crops against insect pests. They have also broken new regulatory ground. Because they are crops, their field-testing is regulated by the US Department of Agriculture (USDA). Because they are pesticides, approval, or registration, for marketing them is the domain of the Environmental Protection Agency (EPA). And when they are also food crops, the Food and Drug Administration (FDA) regulates their safety.
When EPA began registering plants engineered to make the "Bt" toxin in 1995, it was already very familiar with Bt. Sprayed formulations of the Bt protein, naturally produced by the bacteria Bacillus thuringiensis had already been widely and safely used by organic growers for decades.
But Bt crops are different from crops sprayed with Bt. The toxin is inside the plant, so safety risks might differ. And the crops produce it all the time, whether the pests are present or not, raising the risk of insects becoming resistant to it. The initial registrations included rules for growers using the crops to prevent or slow resistance. Those rules require that growers plant areas of non-Bt crops around their Bt fields to serve as "refuges" for nonresistant pests.
The agency set an expiration date on the registrations for Bt cotton and Bt corn so that they can be updated using the latest scientific information on both their risks and their benefits. The original expiration date of April 2001 has already been extended once, to September 2001, to give EPA more time to revise its rules. While EPA is likely to renew the registrations, it must also decide under what conditions, and for how long. Environmental groups and others who felt that EPA made too many favorable assumptions about the safety of these crops the first time around, want to be assured the risks are thoroughly addressed now.
The main contentions are shaping up to be:
The Monarch butterfly. At press time, this issue had a possibility of delaying the entire process. Five new studies by academic scientists on the effect of bt corn pollen on Monarch butterfly caterpillars in the field are set to be published by the National Academy of Sciences. EPA has considered the new data, but it has not been made public, the agency says, because NAS has not finished peer-reviewing them. The Union of Concerned Scientists and other watchdog groups are demanding access to the studies in time to make public comments on them (the public comment period officially ends on August 30, 2001).
Resistance Management. Planting non-Bt refuges takes a bite out of growers profits, but environmental groups say they need to be bigger.
Allergenicity. Friends of the Earth says the StarLink corn problem highlights the need for more allergenicity testing of all Bt plants.