On Monday, June 27, the National Academies of Science, Engineering, Medicine hosted their Third Public Meeting concerning their Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System study. This meeting featured investors, entrepreneurs, academics, and consumer advocacy groups sharing their experiences with regulatory groups concerning genetically modified organisms and their products.
The speakers attempting to get products of genetic modification into the public marketplace regularly expressed a desire for a clearly defined regulatory process . They relayed concerns that the current state of regulations around genetically modified organisms is inadequate to deal with products derived from more advanced modification methods like CRISPR. There were repeated calls for a regulatory process that focuses on the safety of the end products, whether organisms, foodstuffs, or chemicals, instead of the methods by which the genes are modified.
The current uncertainty in the regulatory process lends an incredible amount of risk to any venture that relies on the genetic modification of an organism. Every entrepreneur fears that their product will end up like the AquAdvantage salmon, which still is not available for sale in the United States despite being described by the FDA as “...as safe as food from other Atlantic salmon...” almost six years ago.
Entrepreneurs looking to navigate this regulatory maze would do well to commit a significant amount of time and resources to understanding the regulations relevant to their product. Since, currently, regulations around genetic modification include the methods by which the modifications occur, entrepreneurs should pursue this understanding as early as possible into their process. In doing so they can avoid paths to market that would incur additional regulatory hurdles.
In addition to avoiding governmental regulatory hurdles, entrepreneurs should be aware of how they can make their product more palatable to the general public. They can assuage concerns that the introduced genes are harmful by avoiding introducing new genes as much as possible, or by sticking to genes from closely related organisms. Environmental groups, often concerned with the prospect of genetically modified invasive species can be appeased by making sure that your organism is at a competitive disadvantage to wild-type organisms or that there are systems like suicide switches included in the genetic modifications that limit the spread of the organisms upon escape from containment.
Unlike therapeutic biotechnology, the uncertain regulatory environment and public perception of genetically modified organisms presents significant risks for entrepreneurs and their investors. Until regulations are more concrete, founders should be keeping an eye on and keeping in constant communication with groups like the National Academies, the FDA, the USDA, and the EPA in order to ensure that their products are as acceptable as possible. Spending time on the front end for proper planning will be more than worth it in terms of achieving regulatory compliance once the work is completed. In addition, those who wish to lend their voice to improving the regulatory process can get in touch with those running the National Academies study at biotech@nas.edu.