The non-binding statement presents several principles that each country agrees to follow in order to create an international system that is harmonized on how to regulate products of precision biotechnology, including gene editing.
The statement is in response to frequent regulatory roadblocks that companies can face when developing agricultural applications of precision biotechnology – whether for plants or animals.
Gene editing can create highly beneficial products to more quickly meet consumer and societal needs by using the natural potential within an organism, without introducing any foreign DNA. Examples include healthier cooking oils from gene edited crops and disease resistant, enhanced welfare animals. In many instances, identical products could be achieved using traditional breeding and brought straight to market, but if the same product was made through a gene edit it may be met with increased regulatory process simply because of the difference in method to achieve the same result.
By aligning regulatory approaches across the globe, the U.S. hopes to create an international regulatory environment that does not hinder agricultural products just because they were developed through gene editing as opposed to conventional breeding.
Here in the U.S., USDA has taken a science-based regulatory approach to gene edited plants because the agency understands that many of these products are the same as those developed through conventionally breeding – just using a modern and more precise method.
In a statement published in March, USDA stated with respect to pre-market regulatory approval processes “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional [conventional] breeding techniques…”. USDA still retains the authority to regulate many of these products once in the market if any problems should arise.
But USDA isn’t the only U.S. agency with some oversight of products of agricultural innovation. The Environmental Protection Agency and the Food and Drug Administration may have a role to play, too, and the picture at USDA’s sister agencies isn’t very clear.
The Environmental Protection Agency takes responsibility in regulating plants that have been developed to carry pesticide-like traits (plant incorporated protectants) – but not if achieved through conventional breeding.
Recently, EPA noted they are evaluating gene editing technology and whether such products should fall within their oversight. So, the question becomes: Will they regulate gene edited plants that are identical to those made through conventional breeding? We don’t know, but if they do it would conflict with the international statement that the U.S. has signed on to.
As the International Statement states, “In either case [whether through conventional breeding, transgenic mutation or gene editing], the food, animal, and environmental safety of such products can be adequately addressed by existing regulatory frameworks for agricultural products and existing safety standards based on the characteristics of the product or organism.”
Translation: plants with pesticide-like characteristics developed through gene editing should be judged on what they are as a product and not on the method to achieve them. And since the product in many cases will be the same as ones that already exist or that could be created through traditional methods, they should be treated the same way from a regulatory perspective.
Therefore, EPA should not be regulating plants just because they were made through gene editing. If they were to follow the international statement, they would be more aligned with USDA’s approach: they would not require a pre-market approval process for products identical to those that could be created through traditional methods but would retain the authority to regulate if a problem arose.
The U.S. Food and Drug Administration may also have role to play in oversight of products of agricultural innovation. For plants, FDA has not yet publicly stated how it intends to oversee products developed using gene editing. Regarding gene edited animals, the FDA has carved out a regulatory position that treats these products as “new animal drugs,” a stance that is arguably inconsistent with the recent international statement.
However, the FDA recently announced a “Plant and Animal Biotechnology Innovation Action Plan,” which the agency says, “aims to implement and clarify risk-based policies with the goals of ensuring that developers know what they need to do to efficiently bring a product to market.” Through this program, BIO hopes the agency will establish a right-sized regulatory approach for gene editing, similar to that of USDA and consistent with the broader international statement
The international statement was drafted because gene editing is so new, and the international community has yet to get on the same page as to how to establish appropriate oversight. BIO strongly supports the principles articulated in the international statement and encourages the adoption of these principles by governments around the world—including our own.