White House orders updated biotech regulatory process
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WASHINGTON, July 2, 2015-- The White House issued an executive memorandum today requiring the USDA, EPA and Food and Drug Administration (FDA) to update their strategy for regulating biotechnology products.
The memo “initiates the process” for these three federal agencies--which have oversight responsibilities for products developed through genetic engineering--to modernize the regulatory system and establish periodic updates of the system. The stated objectives are to ensure public confidence in the regulatory process and prevent “unnecessary barriers” to future innovation.
The Office of Science and Technology Policy first issued in 1986 the Coordinated Framework for the Regulation of Biotechnology (CF), which describes the federal regulatory policy for ensuring the safety of biotechnology products. The framework was last updated in 1992, but the memo notes that advances in technology have “dramatically altered the biotechnology landscape” since then and that the CF needs to be updated.
The White House states that although it views the current regulatory system as successful in protecting health and the environment, “in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes have arisen.”
According to the memo, these costs and burdens are limiting the ability of small and mid-sized companies to navigate the regulatory process, as well as making it more difficult for the public to understand how the government evaluates the safety of biotech products.
Marshall Matz, a principal with OFW Law who specializes in food, nutrition, and agriculture, said the White House initiative “is important to maintain U.S. leadership and will be very well received by the smaller biotechnology companies trying to enter the market.”
The White House is requiring the formation of a new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC) that will include representatives from the Executive Office of the President, as well as EPA, FDA and USDA.
Within one year, the working group will clarify the responsibilities for biotech regulation of each agency, as well as develop a long-term strategy “to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.”
Additionally, the three agencies must commission an external, independent analysis every five years of the future landscape of biotechnology products that will identify potential new risks and frameworks for risk assessment.
The working group is also expected to produce an annual report on specific steps the agencies are taking to implement the new strategy.
The Biotechnology Industry Organization (BIO) welcomed the announcement, noting that the CF has come under criticism in recent years for long delays in the biotech approval process. USDA implemented a new process to address the issue, but “similar efforts across all three agencies would prove increasingly beneficial,” BIO said.
Matt O'Mara, acting vice president of BIO's Food and Agriculture Section, said the organization supports a regulatory system that is timely, predictable, based upon the best available science, and incorporates 20 plus years of experience with the technology.”
The Environmental Working Group used the announcement to repeat its call for mandatory labeling of food products made with genetically modified organisms (GMOs).
The announcement “further confirms the need for more transparency in our food system and only further illustrates why mandatory GMO labeling is so necessary.” Scott Faber, EWG's senior vice president, said in a statement.
EWG is against a proposed bill in the House that would establish a voluntary, national system for labeling genetically engineered foods and would pre-empt state laws to mandate labels on foods made with GE ingredients
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