White House aims to modernize biotechnology regulatory process

By Erin Voegele | July 06, 2015

On July 2, the White House issued a memo on modernizing the regulatory system for biotechnology products to heads of the U.S. EPA, USDA and U.S. Food and Drug Administration.

The memo defines “biotechnology products” as those developed through engineering of the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes, or their derived products. The memo does not target products such as human drugs and medical devices.

The memo explains that in 1986, the Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology (CF), which describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products. An update of the CF was issued in 1992 that sets forth a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment. According to the memo, the update affirmed that federal oversight would focus on the characteristics of the product and the environment into which it is being introduced, rather than the process by which the product is created.

The memo notes that each federal regulatory agency with jurisdiction over the products of biotechnology has developed regulations and guidance documents to implement its authority under existing laws. This has resulted in a complex system for assessing and managing health and environmental risks of the products of biotechnology. “While the current regulatory system for the products of biotechnology effectively protects 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,” said the White House in the memo. “These costs and burdens have limited the ability of small and mid-sized companies to navigate the regulatory process and of the public to understand easily how the safety of these products is assured; and, accordingly, they have the potential to reduce economic growth, innovation, and competitiveness.”  

According to the memo, advances in technology have also dramatically altered the biotechnology landscape since the CF update was released in 1992. “A further update of the CF is needed to facilitate the appropriate federal oversight by the regulatory system and increase transparency, while continuing to provide a framework for advancing innovation,” said White House in the memo.

The document outlines several one-year objectives, including the development of an updated CF to clarify the roles and responsibilities of the agencies that regulate the products of biotechnology. The memo also calls for the formulation of a long-term strategy to ensure that the federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In addition, the memo call for commissioning an external, independent analysis of the future landscape of biotechnology products.

To support those objectives, the memo establishes a new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee. Within one year, the working group is tasked with updating the CF and developing a long-term strategy to ensure that the federal regulatory system is equipped to efficiently assess any risks 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. For at least five years after the release of the long-term strategy, the working group is directed to produce an annual report on specific steps that agencies are taking to implement the strategy and any other steps the agencies are taking to improve the transparency, coordination, predictability and efficiency of the regulation of biotechnology products. The memo also directs the EPA, FDA and USDA to commission an external, independent analysis of the future landscape of biotechnology products and directs the three agencies to work with the OSTM and Office of Management and Budget to develop a plan for supporting the implementation of the memo in agency fiscal year 2017 budget requests and in future budget submissions, as appropriate.

The Biotechnology Industry Organization has spoken out in support of the memo. “BIO commends the White House for recognizing that coordination between the agencies that oversee the approval of biotech products – the U.S. Departments of Agriculture, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency – 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 & Agriculture Section. 

“BIO supports a regulatory system that is timely, predictable, based upon the best available science, and incorporates 20+ years of experience with the technology,” O’Mara continued. “We look forward to reviewing the proposal in more detail and working with the administration on this moving forward.”

A full copy of the memo can be downloaded from the White House website.