Genetic engineering of animals used in agriculture has the potential to address some of our biggest challenges—from improving animal health and resiliency, to stopping the next zoonotic disease pandemic. But the current approach to regulating these animals is confusing and deters innovation. A new proposed framework for oversight could incentivize the development and use of this technology.
Currently, animals modified or developed through genetic engineering are regulated as “new animal drugs,”overseen by the U.S. Food and Drug Administration (FDA).
BIO has long expressed concern over this approach, which deters R&D and unnecessarily stigmatizes these animals and their progeny, significantly reducing the likelihood that such animals will be grown by producers or accepted by consumers. (More background here and here.)
The success of animal biotech is critically dependent on efficient and effective regulatory systems that ensure animal health and welfare, food safety, and protection of the environment—without disincentivizing development and commercialization of innovation.
The U.S. Department of Agriculture (USDA) proposed a new framework for oversight of these animals, under which genetically engineered animals intended for agricultural use would be administered jointly by USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety Inspection Service (FSIS).
BIO just submitted comments on the proposed framework, which is based on authorities more appropriate for overseeing animal health and creates a much clearer path to commercialization as well as greater transparency for consumers and stakeholders.
The bottom line: BIO remains committed to continuing to work collaboratively with USDA, FDA, and other agencies to urgently develop a regulatory system that continues to ensure the safety of animals, consumers, and the environment while fostering innovation and expedited commercialization of beneficial improvements to agricultural animals.
Read BIO’s full comments.
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