Improving biotech transparencyImproving biotech transparency
Regulatory policy for ensuring safety of biotech products to be updated.
July 17, 2015
THE White House has directed the three U.S. agencies that oversee biotech crop products to improve and modernize their regulatory framework to boost confidence in the system that regulates and oversees new biotechnology.
The order, announced in a statement by the White House Office of Science & Technology Policy, followed demands by consumers, food-related organizations and businesses for tighter regulation of genetically modified crops amid a nationwide debate over whether they should be labeled.
The first framework was issued in 1986 and updated in 1992. In order to address the advances made in science and technology since 1992, the three federal agencies with jurisdiction over biotech regulations and guidance documents have been called upon to revisit the Coordinated Framework.
"The complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies," the White House memorandum said.
The memo directs the three oversight agencies — the Environmental Protection Agency, the Food & Drug Administration and the U.S. Department of Agriculture — to update the Coordinated Framework, develop a long-term strategy to ensure that the system is prepared for future biotech products and commission an expert analysis of the future landscape of biotech products to support this effort.
The memo calls for a Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee that will include representatives from the executive office of the President as well as from EPA, FDA and USDA. Within one year, the working group shall take steps to increase the transparency, coordination, predictability and efficiency of the regulatory system for biotech products.
Matt O'Mara, acting vice president of the Biotechnology Industry Organization's (BIO) food and agriculture section, emphasized that "coordination between the agencies must be a priority to encourage innovation by improving transparency, timeliness and predictability of the regulatory system."
The Coordinated Framework has come under criticism in recent years for impeding the timely approval of much-needed and long-reviewed biotech products. USDA, however, has since implemented new processes to address the issue; similar efforts across all three agencies would prove increasingly beneficial, BIO said.
"BIO supports a regulatory system that is timely, predictable and based upon the best available science and incorporates 20-plus years of experience with the technology," O'Mara noted. "We look forward to reviewing the proposal in more detail and working with the Administration on this moving forward."
The Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of EPA, USDA and FDA in the regulatory process. This update will help clarify which biotech product areas are under the authority and responsibility of each agency and outline how the agencies should work together to regulate products that may fall under the authorities of multiple agencies.
Second, the Administration will develop a long-term strategy, after public input, to ensure that the federal regulatory system is well equipped to efficiently assess any risks associated with future biotech products. This includes performing periodic horizon scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system and creating user-friendly digital tools for presenting the agencies' authorities, practices and bases for decision-making.
Third, the Administration will commission an outside, independent analysis of the future landscape of biotech products. The Administration has already asked the National Academies of sciences, engineering and medicine to conduct such an analysis.
The Administration also plans to hold public engagement sessions in different regions of the country. The first will be this fall in Washington, D.C.
The update to the Coordinated Framework will undergo public notice and comment before it is finalized.
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