There is no statutory requirement that the FDA regulate gene editing in food producing animals, much less that they do so as an “animal drug”. The FDA’s proposed regulatory framework is the result of a decades-old administrative decision, based on older transgenic biotechnology. This regulatory path will result in a lengthy and expensive approval process, and functionally make any gene edited animal a living animal drug—and every farm raising them a drug manufacturing facility. It does not allow for a risk-based approach that takes into consideration the familiarity or complexity of the genetic changes, and the fact that they could be achieved through conventional breeding
techniques (though at the expense of time and genetic improvement from decades of animal breeding). The FDA approach is also out of step with the regulatory pathways under development in the rest of the world. APHIS already regulates gene editing in plants under the Plant Protection Act. They have a proven track record in risk-based, pro-science regulation of biotechnology. This regulatory framework can be readily adopted to animals under the Animal Health Protection Act. NPPC does acknowledge that some products of gene edited animals may
be appropriately regulated by the FDA as human or animal drugs or devices—but not the animals themselves.
NPPC strongly supports moving regulatory oversight of gene editing in animals from the FDA to the USDA’s Animal and Plant Health Inspection Service (APHIS). APHIS, which already regulates gene editing in plants, can ensure proper and risk-based regulatory review under the Animal Health Protection Act. Regulation of gene editing in animals by the FDA as an “animal drug” is not appropriate or practicable.
- Gene editing is making simple changes or deletions within the pig’s
- Gene editing offers pork producers remarkable promise to improve the
health and welfare of their pigs, and the safety of the pork they produce.
- A sound, risk based, and pro-innovation regulatory review process is
essential for producers to have this opportunity.
- The FDA, currently, is seeking to regulate gene editing as an animal
drug – this is not a good fit for this technology.
- Regulating gene editing as an animal drug will make this scientific
breakthrough unavailable to livestock farmers.