The surprise in the Obama administration’s disclosure it was directing government agencies to update the Coordinated Framework for the Regulation of Biotechnology is how long it has taken to launch this effort. The White House at last has directed the Environmental Protection Agency, the Food and Drug Administration and the U.S. Department of Agriculture to adapt regulations to changes in the biotechnology landscape occurring in the past quarter century. Further, the changes should be made anticipating “the future landscape of biotechnology products.”
For years, stakeholders have criticized a regulatory process put in place in the late 1980s that is expensive, discourages innovation and has not given consumers confidence in the safety of bioengineered crops. In testimony before a House committee four years ago, Roger N. Beachy, founding president of the Donald Danforth Plant Science Center in St. Louis, said the regulatory process had not adapted to the learnings of a quarter century of field experience, to safety enhancements or to market needs. Meanwhile, more than 2 billion acres of bioengineered crops have been planted safely by more than 15 million growers globally.
Dr. Beachy estimated the cost of regulatory approval for products with a new genetically engineered trait at $5 million to more than $25 million with time to market of as much as 10 years. In an environment in which anti-biotechnology activists have made headway in stirring up consumer fears about the technology, a thoughtful, thorough and streamlined regulatory process grounded in sound science is more important than ever.