Gene editing has enormous potential to improve health and food production, but innovation must be governed by well-rooted standards of safety and effectiveness, said FDA Commissioner Stephen Hahn. “The agency is a trusted global regulator and we are committed to overseeing this space in a manner that fosters innovation, protects consumer confidence and protects the public health.”
The remarks, apparently the first by the new FDA chief on the subject, were released over the weekend. The hog industry has campaigned since last June to transfer jurisdiction over genetically engineered animals to USDA, which handles GE plants. The FDA, with roles in food and medicine, is in charge of gene-altered animals. Groups such as the National Pork Producers Council say gene editing is a safe technology and the USDA would act more rapidly than FDA on GE animals.
While the USDA has approved hundreds of GE plants, the FDA spent years in review before approval in 2015 of a GMO salmon, the first GE animal allowed into the U.S. food supply.
On the same day that Hahn commented, the journal Nature Biotechnology published an FDA-authored analysis that described how FDA scientists found unintended alterations that were introduced into bulls by genome editing. “The bacterial bits included a few genes for antibiotic resistance commonly found in plasmids,” used in this instance to deliver the hornless gene into cattle cells, reported Wired last August. The discovery derailed a project by a Minnesota-based company to create a herd of genetically hornless dairy cattle in Brazil.
“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,” said Steven Solomon, director of FDA’s Center for Veterinary Medicine. “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.”
In a commentary in the journal, Solomon said, ‘We want to support the timely development of beneficial products but not at the expense of abdicating our critical role in protecting consumer and animal health.”
The FDA fielded a risk-based regulatory framework for plant and animal biotechnology in late 2018. Hahn urged researchers and companies to take part in the voluntary program so FDA could identify low-risk projects that would need little regulation.
“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,” said the FDA commissioner. He said FDA would soon begin a public education campaign on “the safety and benefits of agricultural biotechnology products.”
President Trump issued an executive order last fall that called for streamlining of federal regulation of ag biotech and, referring to gene-edited crops and animals, told regulators to used their power “to exempt low-first products of agriculture biotechnology from under regulation.”
The FDA homepage on “Animals with intentional genomic alterations” is available here.