In an effort to reassure both businesses and a skeptical public, the federal government has released a coordinated framework for regulating biotechnology products that it says will be based on the best available science.
This represents the federal government's first comprehensive review and coordination of biotech regulations in 30 years — a period that has seen tremendous changes in the technology, marketplace and public opinion.
The framework outlines the roles and responsibilities that the three federal agencies charged with biotech oversight — EPA, USDA and FDA — will play in regulating products created through biotechnology. It is based on a 14-month analysis of the federal regulatory system that included the review of some 900 comments submitted by the public.
Both the coordinated framework and a new national strategy for modernizing the regulatory system are intended to “offer the public a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology... and protect[s] health and the environment,” according to an announcement from the White House.
The coordinated framework is also meant to address concerns expressed by biotech product developers who contend the government's slow, expensive regulatory process has hindered Amerian innovation and investment in the technology.
For example, it took AquaBounty 20 years and $80 million to secure federal approval of its fast-growing AquAdvantage® Salmon — the first genetically engineered animal approved for human consumption.
“The concern prior to our approval was that delays and the process were flawed, that the requirements were irrational, and they were being driven by organizations outside the regulatory process which had a vested interest in preventing new product introduction,” AquaBounty CEO Ron Stotish told the Alliance for Science.
The White House announcement assures product developers that the new framework will establish “transparent, coordinated, predictable and efficient regulatory practices” and will “help product developers and the public understand what the regulatory pathway for products might look like.” It includes tools for helping small companies navigate the process.
The framework also calls for improved interagency collaboration, clarifying how the federal government will regulate genetically engineered insects and products developed through gene-editing, facilitating better interaction among EPA experts responsible for regulating biopesticides and plant-incorporated protectants, and updating procedures for evaluating food derived from new plant varieties.
The new strategy, meanwhile, “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.”
The strategy is tied to an ongoing National Academy of Sciences study that seeks to identify the types of biotech products that may be developed over the next five to 10 years, the risks associated with these products, and the scientific tools and capabilities that could help agencies assess and regulate new products.