The governmental response to genetically-edited animals is and will continue to be a key consideration. This post explores existing and proposed regulations and laws affecting genetically-edited animals. First and foremost, I think it is important to have science-based laws. The terminology, reasoning, and application of these laws should be grounded in science rather than loud interest groups, fear mongering, or an incomplete understanding of complex ideas. Researchers, scientists, farmers, packagers, marketers, and consumers should all participate in educating the legislators who will pass the laws that affect this industry.
Genetically-engineered animals are often defined in current laws as those in which the genetic material was altered in a way that does not occur naturally. Genetically edited animals may not fit in this simplistic definition. As explained in my last post on genetic editing, most gene editing is based on natural mutations in the animals that could have been accomplished through selective breeding over many generations. Pigs resistant to PRRS, for example, could occur naturally. Cattle without horns occurs naturally through selective breeding.
Federal Government: The U.S. government does not have any federal legislation that is specific to genetically modified foods. Instead, they are regulated pursuant to health, safety, and environmental legislation governing conventional products. The FDA regulates genetically modified foods as part of a coordinated framework of federal agencies, including the EPA and USDA. The framework focuses on the nature of the products rather than the process in which they are produced.
The FDA regulates traditional genetically engineered animals as veterinary drugs, arguing the gene inserted into the animal meets the definition of a drug. Usually the FDA requires a genetically engineered animal to be the subject of an approved new animal drug application based on a demonstration that it is safe and effective for its intended use. A new animal drug application for a genetically engineered animal must include information on the animal’s identification, chemistry, clinical purpose, labeling, composition, manufacturing methods, safety, effectiveness, environmental impact, and other information.
There is no federal law requiring that genetically engineered foods be labeled as such. Proposed federal legislation that would mandate labeling of any genetically engineered food has been introduced several times, but has never advanced beyond the committee stage. This past summer, the House of Representatives passed bipartisan legislation that would keep states from issuing mandatory labeling laws for foods that contain genetically modified organisms. The Safe and Accurate Food Labeling Act of 2015 (HR 1599), which passed the House 275-150 in July 2015, would instead create a federal standard for the voluntary labeling of foods with genetically modified ingredients. The bill languished in the Senate and was not brought up for a vote.
I think regulating genetically engineered animals as “animal drugs” is a stretch. The nearly 30-year-old framework used by the FDA, EPA, and USDA is outdated. New genetic technology should not be jammed into old veterinary drug regulations that were never intended to apply to genetically edited animals. Perhaps recognizing this problem, on July 2, 2015, the White House announced it was reviewing the framework for regulating genetically engineered products. It directed the FDA, EPA, and USDA to develop a long-term strategy to ensure the federal system was prepared for the future of biotechnology.
State Government: An Indiana state senator recently proposed a bill in the Indiana Senate for the state to regulate the labeling of genetically-engineered food. Senate Bill 60 would require genetically-engineered food to be labeled subject to several exceptions. The bill defines genetically-engineered food to include food produced from an organism in which: the genetic material has been changed through the application of: (1) in vitro nucleic acid techniques, including DNA techniques and the direct injection of nucleic acid into cells or organelles; or (2) the fusion of cells or hybridization techniques that overcome natural barriers, where the donor cells do not fall within the same taxonomic family, in a way that does not occur naturally. The bill would prohibit genetically-defined food and processed food from being labeled “natural.” Like other bills like it, this proposal suffers from the problem of what "occurs naturally" and what doesn't. As I mentioned, much of what gene editing does could occur naturally. We’ll see where the bill goes from here. Some states, like Maine, Vermont, and Connecticut, have passed mandatory GMO labeling laws. Similar bills were rejected in California and Oregon.
What's Next: I think the federal government needs to change the way it regulates genetically engineered animals. Advances in science have made the 30-year old federal framework seem archaic and obsolete. If an engineered animal does not contain foreign genetic material, it should not be regulated or categorized differently than other animals. Animals that contain foreign genetic material, once deemed safe and effective through a predictable, efficient, analysis should be welcomed into the food stream. Similarly, the federal Safe and Accurate Food Labeling Act should be passed to prevent states from creating a patchwork of differing standards for genetically edited animals. Having to meet one standard in Vermont and a different one in Oregon creates added costs for food growers and packagers. Uniform science-based labeling requirements make more sense. Science allows us to produce more food with less of an impact on the environment—our government should enable, rather than discourage, such advances.