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Viewpoint: FDA plan to treat gene-edited animals like ‘walking drugs’ will stifle agricultural innovation

| | November 8, 2018
Screen Shot at PM
Hornless heifer calf #1 of gene-edited bull alongside horned Hereford control calf on right (Image source: Alison Van Eenennaam/Twitter)
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Nov. 3 marked One Health Day ( – an international campaign to recognize the importance of a broad, trans-disciplinary approach to solving global health challenges. The One Health idea recognizes the inextricable interconnections among all people, animals, plants and their shared environment.

As a veterinarian and pork producer, I see these links in many ways, especially in efforts to prevent and treat disease and in work to ensure a safe, stable, efficient and affordable food supply. I also see an obstacle to achieving goals in these areas. Namely, I am concerned by the U.S. Food and Drug Administration (FDA) attempts to claim regulatory oversight of gene edited livestock rather than cede that oversight to the appropriate authorities from the U.S. Department of Agriculture (USDA).

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Unfortunately, the FDA is stretching a decades-old administrative framework designed for transgenic biotechnology to lay oversight claim to gene editing in livestock. The FDA approach would regulate the edited animal’s DNA, thereby turning the animal itself and its progeny in perpetuity into the regulated product – a walking “animal drug” and the farm, a drug producing facility. Farmers and producers would face costly and lengthy FDA approval, effectively rendering this technology unavailable to them. This is not appropriate or practicable and will stifle innovation.

Read full, original article: Only the USDA can unlock gene editing’s potential

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