The White House Office of Science and Technology Policy (O.S.T.P.) on July 2 announced the Obama administration will modernize the nation’s system for regulating bioengineered crops and other products of biotechnology. The O.S.T.P. said the administration also will establish mechanisms for periodic updates of that system.
In a memo to the heads of the U.S. Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency, the three federal agencies with regulatory responsibilities with regard to biotechnology, the O.S.T.P. said, “The objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.”
In 1986, the O.S.T.P. issued the Coordinated Framework for the Regulation of Biotechnology, which outlined federal regulatory policy for ensuring the safety of biotechnology products. The framework was updated in 1992.
“While the current regulatory system for biotechnology products effectively protects health and the environment, advances in science and technology since 1992 have been altering the product landscape,” the O.S.T.P. noted. “In addition, 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 pro-ducts can be unduly challenging,
especially for small companies.”
The O.S.T.P. said the administration’s first step in updating the Coordinated Framework will be clarifying the current roles and responsibilities of the three agencies in the regulatory process.
“This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies,” the O.S.T.P. said.
The administration then will develop a long-term strategy to ensure that the federal regulatory system is well-equipped to assess any risks associated with the future products of biotechnology, the O.S.T.P. continued. This will include 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 basis for decision-making.
The administration also will commission an outside, independent analysis of the future landscape of the products of biotechnology. The O.S.T.P. said it already has asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.
“The Biotechnology Industry Organization (BIO) commends the White House for recognizing that coordination between the agencies that oversee the approval of biotech products must be a priority to encourage innovation by improving transparency, timeliness and predictability of the regulatory system,” said Matt O’Mara, acting vice-president of BIO’s food and agriculture section.
Mr. O’Mara noted the Coordinated Framework has come under criticism in recent years for impeding the timely approval of much-needed and long-reviewed biotech products. At the same time, the U.S.D.A. has implemented new processes to address the issue, and similar efforts across all three agencies would prove beneficial, Mr. O’Mara observed.
The Center for Science in the Public Interest said it welcomed the White House announcement.
The consumer group said the F.D.A. in the future must play a more substantial role than it does in the current process, and the U.S.D.A.’s oversight needs to cover all bioengineered crops, not just those that are designed with “plant pest components.” The C.S.P.I. said the U.S.D.A. should consider other risks, including development of resistant weeds and insects.
The C.S.P.I. said the call to engage experts who can analyze the potential products from future biotechnologies was late in coming but necessary to ensure food and environment safety.
“It is essential that federal regulators keep up with scientific research and product development and adapt their oversight to address any potential risks that might arise,” the C.S.P.I. said.
