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Obama Administration Tackles Biotechnology Regulatory Process

July 7, 2015

On Thursday, July 2, the Obama Administration released an executive memorandum requiring the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) to reconsider and update their regulatory process for biotechnology products.

The White House Office of Science and Technology Policy initially tasked these three federal agencies with oversight of the safety of biotechnology products through the 1986 Coordinated Framework for the Regulation of Biotechnology. There has only been one update to this initial framework since it was established, in 1992, and there is a growing need for transparency and new regulatory strategies to address the rapidly changing science associated with biotechnology products and processes.

The White House announcement stems from the confusion surrounding the nearly 30-year-old regulatory system, which is complicated by complex arrangements of agency review and oversight. The memo calls on USDA, FDA, and EPA to not only update the Coordinated Framework, but also develop a “long-term strategy to ensure that the system is prepared for the future products of biotechnology” and authorize an “expert analysis of the future landscape of biotechnology products to support this effort.”

The need to update the federal regulatory approach to biotechnology is not a new issue; many farmer, consumer, and environmental organizations have been pushing for stricter regulations and a more transparent regulatory system since commercialization began. But GE crop advocates, including the biotechnology industry, say that the existing regulations are too stringent and prevent innovation from researchers and smaller companies due to slow review periods and associated costs.

The Obama Administration’s memorandum does not specify any immediate changes to existing biotechnology regulations. Instead, it lays out three different components intended to improve the transparency, coordination, and effectiveness of the regulation system. For example, the memo establishes a Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee, with representatives from the Executive Office of the President, EPA, USDA, and FDA, will be created. Within a year, the Biotechnology Working Group is expected to:

  • Update the Coordinated Framework to clarify which biotechnology products fall under jurisdiction of the USDA, EPA, and FDA, and develop guidelines for agency cooperation to regulate products that fall under multiply agency authority;
  • Create a long-term strategy, following public input, to guarantee that the biotechnology regulatory system is capable of assessing risks associated with future biotechnology products. This will include directing support for research and science to inform these regulations, creating user-friendly tools for public awareness, and conducting periodic scans for new biotechnology products;
  • Authorize a third-party, independent analysis of the future landscape of biotechnology products that will identify new risks and frameworks for risk assessment to inform future policy making; and
  • Engage with the public to convey how the Federal government employs a scientifically sound, risk-based approach to regulating biotechnology products, and explaining which types of products are regulated, which types of products are not regulated, and why.

In addition to the above actions, for at least five years following the release of the long-term strategy described above, the Biotechnology Working Group will produce an annual report that will be made publicly available by the Executive Office of the President. It will lay out the various steps agencies are taking to implement the strategy and any other steps that the agencies are undergoing to improve the transparency, predictability, coordination, and effectiveness of the regulation of biotechnology products.

This memorandum comes at a time when public mistrust of biotechnology products and the process by which they enter commercialization is high, and when many are calling for the mandatory labeling of GE foods. Though the memo lacks any direct mention of GE food labeling, this issue has become a hot topic of interest in Congress recently, and would presumably be part of the multi-agency assessment of changes needed to enhance transparency.

NSAC continues to advocate for a comprehensive biotechnology regulation system where the economic, environmental, and social sustainability of our nation’s agriculture and rural communities are addressed and protected. It is unfortunate that this Presidential memorandum focuses solely on the economic burdens to small business attempting to navigate the regulatory process and fails to acknowledge the risks and concerns the technology poses for non-GE farmers and the environment.

The memo goes so far as to state that the current biotechnology regulatory system “effectively protects [public] health and the environment.” This ignores the very real and documented issues of contamination (from gene and pesticide drift) and subsequent economic losses to non-GE farmers; the lack of any mechanism to determine liability and provide compensation in such events; and the troubling growth of herbicide-resistant weeds around the country and resultant use of more potent herbicides to combat them. USDA has been soliciting comments on these topics; it seems incongruous that the Administration would not acknowledge the existence of these issues that result from failings in the current regulatory process.

We applaud the Obama administration for taking action to improve coordination across the agencies tasked with biotechnology regulation, and for its emphasis on transparency, public engagement, and independent science in the regulatory system.  However, we urge the Administration not to gloss over the social and environmental implications of biotechnology products and their regulation, and to ensure the multi-agency process includes a robust assessment of the changes needed to bring more fairness to the biotechnology regulatory process for all sectors of US agriculture.

You can read NSAC’s recent comments to the USDA on GE crop oversight here.

Categories: Conservation, Energy & Environment, General Interest, Organic

One response to “Obama Administration Tackles Biotechnology Regulatory Process”

  1. Leonard Hayflick says:


    Thanks for these blogs. The writing is excellent!

    Grand Dad