FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
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.
“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 cattleExternal Link Disclaimer,’ 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 mattersExternal Link Disclaimer,’ 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.”