Has the Food and Drug Administration failed the public  by making it far too difficult to bring genetically altered animals to the market? Lena Lewis, a Batten graduate student, shares co-author credit for a recent Public Comment on biotechnology regulation that says the FDA is stifling the innovation of genetically altered animals, effectively blocking  health improvements that could prevent the spread of disease like Lyme and schistosomiasis.

Earlier this month, the George Washington University Regulatory Studies Center posted on its website a Public Comment to the FDA written by Lewis and Randall Lutter, a Professor of Public Policy at Batten. Lewis is earning a master’s degree in public policy.

They argue that the FDA’s proposed process of getting genetically engineered and genome-edited animals to market will be so cumbersome that many potential innovators will not even bother to develop these animals.

Citing the FDA’s approval of genetically engineered plants, Lutter and Lewis “conclude that a regulatory approach less stringent than proposed by FDA would be more consistent with longstanding regulatory principles as well as other federal policies.”

Their summary of “How to Regulate Genome-Edited Animals? A Comment on FDA’s Proposed Guidance” is here, and their complete Public Comment is here.

“There are no a priori reasons that genome edited animals merit more stringent regulatory oversight than plants, other than concerns for animal welfare,” Lutter and Lewis write. “Both plants and animals can be consumed as food and cause allergic reactions and/or food-borne illnesses.”

They also write that “genome editing, like genetic engineering” can “substantially benefit animal welfare.”

And they cite the likely substantial “chilling effect of a complex and burdensome regulatory process.” Only one genetically engineered animal, AquaBounty’s fast-growing AquaAdvantage salmon, has been approved for food.

In a later, separate discussion of the Public Comment, Lewis said, “The FDA should at least do a benefit-cost analysis of their proposed regulation; they are not even allowing for the possibility that the benefits of genome-edited animals could be so great that they could outweigh the potential downsides.

“It’s also possible that all of the extra regulatory requirements for genome-edited animals do very little to reduce any risk associated with them — the risk in some cases may be extremely low to start with.”

Lewis explained that traditional “genetic engineering” practices are different from the new approaches of “genome editing.”

“Genome editing causes the organism to alter its own DNA, without inserting the DNA from a different organism. It is more precise and cheaper, and has the potential to make biotechnology accessible to many more people.” Their Public Comment points out that the FDA’s judgment is flawed because it plans to unnecessarily restrict “genome editing” by holding genome editing to a higher standard than other methods already used to create new traits in plants and animals.

Their Public Interest Comment was submitted to the Food and Drug Administration’s Draft Guidance for Industry #187, “Regulation of Intentionally Altered Genomic DNA in Animals.”