Fourteen months ago, the Obama administration launched the first comprehensive review in 30 years of the roles of the USDA, the EPA and the FDA in regulating biotechnology. In a follow-up, the White House released a proposed update to the Coordinated Framework for the Regulation of Biotechnology — the division of labor among regulators, first issued in 1986 — and a national strategy for modernizing biotechnology regulations.
The three-prong regulatory system “contributed to the growth of a large and competitive biotechnology sector in the United States and abroad,” wrote five administration officials in a White House blog. An update was needed, they said, because of advances in science and because of the overlapping jurisdiction over biotech products. “Navigating the regulatory process for these products can be challenging, especially for small companies”
In the proposed update of the Coordinated Framework, the administration offers graphics that illustrate each agency’s duties and a table that summarizes FDA, EPA and USDA responsibilities. Public comment will be accepted for 40 days on the update once it appears in the Federal Register. In the national strategy, the three regulators say they are committed to making a timely decision on questions of jurisdiction. They also will clarify regulation of genetically engineered insects. The National Academy of Sciences is expected to report soon on ways to improve the regulatory system for biotechnology.