I explained to Lars that this all started in 1986 when the White House published a white paper, The Coordinated Framework for Regulation of Biotechnology, which got the science right—regulation should be risk-based, not dictated by the method used to develop an organism. But, the USDA and EPA weren’t interested in science-based regulation. For almost 40 years, they got it wrong. Then, in 2020, the USDA finally made a long-overdue correction, recognizing that if a genetic change could have been achieved through conventional breeding, it shouldn’t be treated as posing unique risks simply because modern molecular tools were used. Environmental groups challenged that decision, and Judge Donato—a federal judge in California—wasn’t convinced by the USDA’s defense of its policy, thereby returning agriculture to an outdated, arbitrary regulatory framework.
Lars and I then shifted gears to avian flu and free-range chickens. While free-range flocks are more vulnerable to infection spread by migrating wild birds, the lack of surveillance in the poultry industry, worsened by regulatory capture, is a more significant long-term concern.
Here is our entire conversation.
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Henry I. Miller, MS, MD
Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.
