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FDA Statement

FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

For Immediate Release:
Statement From:
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

“Genome editing is a groundbreaking technology used to introduce intentional genomic alterations in animals and has the potential to improve human and animal health, animal well-being and to enhance food production and quality. It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness.

“This is a tremendously exciting field. Because we’re committed to fostering advances in this space, we take a risk-based approach to oversight. We want to ensure that the intentional genomic alterations in animals are safe for the animal, safe for people eating food products from the animal and that the alteration does what it’s intended to do. That’s why we encourage sponsors to participate in our Veterinary Innovation Program, which facilitates advancements in the development of innovative animal products by providing greater clarity in the regulatory process, encouraging development and research and supporting an efficient and predictable pathway to approval.

“We are taking steps to help ensure confidence in products of biotechnology and will soon be undertaking a public education campaign to help consumers learn about the safety and benefits of agricultural biotechnology products. We are committed to partnering with America’s farmers, innovators, biotechnology companies and research universities who are at the forefront of this remarkable moment of scientific advance.

“The FDA is leveraging our scientific and technical expertise and regulatory experience to oversee intentional genomic alterations in animals developed using novel techniques, such as genome editing, through a timely and efficient process. The agency is a trusted global regulator and we are committed to overseeing this space in a manner that fosters innovation, promotes consumer confidence and protects the public health.”

The following statement is attributed to Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine.

“Today, the journal Nature Biotechnology published the FDA-authored analysis ‘Template plasmid integration in germline genome-edited cattle,’ which describes how a bioinformatics method developed by FDA scientists was able to detect previously unreported, unintended alterations in genome-edited bulls. The analysis emphasizes the FDA’s expertise and critical role in risk-based evaluation of intentional genomic alterations.

“Our analysis demonstrated that genome editing in animals can have unintended consequences, and in this case, it caused foreign DNA to be integrated into the animals’ genomes. While the existence of an unintended alteration does not necessarily mean that the genome edit is unsafe to animals or consumers, it does show that both scientists and regulators need to be alert to the potential for such unintended alterations to take place.

“A companion piece, ‘Genome editing in animals: Why FDA regulation matters,’ also published today explains the value of the agency’s oversight of intentional genomic alterations in animals to protect animal and human health, even when the intended modification seeks to replicate a naturally occurring mutation. The commentary further describes the FDA’s intent to support innovative scientific approaches, while balancing the agency’s role to protect public health through a risk-based approach.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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