October 6, 2015

Regulatory Reboot for Biotech?

Seller Beware: Consumer Protection Insights for Industry

The Obama administration has today solicited public input into its process of updating the nearly 30-year old regulatory "roadmap" that has been relied upon since the 1980s to guide the regulation of materials produced using genetic engineering techniques. Products that are subject to the various regulations concerning genetically-engineered organisms have utility in a number of markets in the United States; these include biotech crops and medicines, as well as certain plant-based materials that can be used to produce substitutes for petroleum-based fuels. Makers and users of such products may want to consider submitting comments or data for consideration in this process. Whether or not they submit comments, regulated entities will want to pay close attention as new developments begin to emerge from the White House's Office of Science and Technology Policy.

Current Context

In the absence of a single, unifying statute governing the products of biotechnology, regulation in the United States is guided by the Coordinated Framework for Regulation of Biotechnology -- published in 1986. In the more than 20 years since the policy's one and only update, we have seen widespread commercialization of genetically engineered crops as well as the development of biotechnology applications barely conceivable when the Coordinated Framework was drafted. Examples abound of the dramatic influence that genetic engineering is having on commerce. In agriculture, over 400 million acres of land worldwide have been planted with genetically engineered crops. In the United States -- which has approximately 40% of this global acreage -- 93% of soybean, 94% of upland cotton, and 88% of corn acres have been planted with genetically engineered seed varieties. Faster-growing Atlantic salmon have been developed, and the products of biotechnology have found applications including the recently-approved use of an anti-clotting protein derived from the milk of transgenic goats. In the coming years, the role of genetic engineering in the production of foods and medical treatments seems likely to grow exponentially.

White House Directive

The White House has assembled a Working Group to update the Coordinated Framework, including officials from the Executive Office of the President as well as representatives of the USDA, FDA, and EPA. The Working Group has been charged with accomplishing three goals by mid-summer 2016: First, revise the Coordinated Framework, addressing which regulatory tasks lie within each agency's purview and developing a standard mechanism for coordinating the agencies' functions. Second, develop a long-term strategy for assessing new biotechnology, the goals of which include ensuring assessments are based on science, streamlining the evaluation processes, adapting to ongoing innovations, and sharing information on the evaluation process with the public. And third, work with the National Academy of Sciences to arrange an independent assessment of the future landscape of biotechnology and the potential risks that may or may not be presented by novel biotechnologies. Interestingly, the White House directive states that the planned activities will not focus on "human drugs and medical devices"; the food industry, however, is likely to be a focus.

The White House has signaled that it would like to make the process of assessing biotechnology products more coordinated, efficient, and "transparent" (improving the flow of information to the public). It is as yet unclear, however, what path the Working Group will take in pursuit of these goals. It would not be surprising eventually to see significant regulatory amendments proposed -- perhaps to EPA, FDA, and USDA regulations. It is unlikely, however, that new regulations or amendments will be issued until the Working Group has accomplished its initial three goals.

Today's request for public input provides an opportunity for interested parties to influence the Working Group's strategy at a relatively early stage in the process of updating the Coordinated Framework. Although the public will have another opportunity to comment once a draft strategy has been developed, it might be easier to influence the regulatory process by providing input at an early stage. Comments may be submitted via the Federal eRulemaking Portal, for Docket No. FDA-2015-N-3403.

© Arnold & Porter Kaye Scholer LLP 2015 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

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