September 16, 2015

Regulatory Reboot for Biotech?

Arnold & Porter Advisory

The Obama administration has made a public commitment to rethinking the nearly 30-year old regulatory "roadmap" that has been relied upon since the 1980s by the developers and users of the materials produced using genetic engineering techniques. As a result, the regulated community will want to pay close attention as new developments begin to emerge from the White House's Office of Science and Technology Policy (OTSP) and the key regulatory agencies with oversight of biotechnology products. Whether meaningful changes in existing policy will be formulated, publically vetted, and implemented before there is a change in administrations remains to be seen.

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, initially 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. In this time, the policy has drawn criticism from many quarters-from industry, opponents of biotechnology, and even certain government offices. It is perhaps not surprising, then, that the White House-through OTSP-has announced an effort to update the Coordinated Framework over the next year. Where this effort will lead remains unclear. Given that the Framework's critics and the regulated community are far from unanimous in their opinions, the interagency Working Group leading the reform effort is likely to receive a great deal of conflicting advice at the public meetings that are scheduled to begin this fall. 

Current Context

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. Technology is emerging that may lead to heavy reliance on genetically engineered products outside the crop context. Faster-growing Atlantic salmon have been developed using genetic components from the ocean eelpout and the Chinook salmon. In the field of medicine, the products of biotechnology have found applications including the recently approved use of an anti-clotting protein derived from the milk of transgenic goats. Biotechnology products have potential uses in not only fuel spill clean-up, but also development of bio-based fuels. In the coming years, the role of genetic engineering in the production of foods, medical treatments, and industrial applications seems likely to grow exponentially.

Under the 1986 Coordinated Framework, three agencies are responsible for regulating commercial uses of genetically engineered products in the United States-the USDA, FDA, and EPA. (The National Institutes of Health (NIH) also has a role in the context of established Guidelines governing research using certain products of genetic engineering that is funded by NIH.) The division of labor among these agencies and their respective responsibilities have remained largely unchanged since the Coordinated Framework was first developed. However, each agency has promulgated its own statute-specific implementing regulations and has adapted its respective program to the increasing complexity of addressing biotechnology in the context of its unique authorities. The result is a somewhat convoluted network of regulations, which the White House acknowledges can be confusing for the general public. The framework has been known to confuse professionals as well. The regulatory complexity has the potential to deter innovation and to harm the competitive position of US companies-especially smaller ones. 

White House Directive

The White House has assembled a Working Group to tackle this issue, made up of 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. With a mind toward keeping its regulations up to date, the White House has provided, going forward, for the Coordinated Framework to be updated regularly and for the independent expert assessment to be repeated every five years. Meetings with the public to discuss the current reform effort are scheduled to begin this fall.1

Significantly, the White House directive reaffirms a risk-based approach to evaluating biotechnology, in which regulators' focus is on the regulated product, rather than on the processes used to create it. This approach has been a defining feature of US biotechnology regulation since the 1992 update to the Coordinated Framework, and distinguishes the United States from other nations that have singled out products for regulation based on the genetic engineering used in their development. Indeed, several European nations have taken the opposite approach, restricting or banning genetically engineered products across the board. The White House seems to be conscious of the role that the risk-based approach has played in making the United States a leader in the biotechnological realm, and seems committed to preserving this approach-even when contemplating a large-scale reassessment of US biotechnology regulation.

Road Ahead

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. A signal that regulatory reform will need to await completion of the first part of the Working Group's mission came when the USDA's Animal Plant Health Inspection Service (APHIS) withdrew in March of this year its long-debated 2008 proposal to modify its own biotechnology-related regulations. It seems possible that the proposed changes were tabled so that they could be wrapped into a broader package of regulatory reforms. 

Given the slow pace of regulatory rulemaking and the foreseeability of a change of administrations, the impact of the current reform effort may not be evident for years to come-but it could significantly influence US biotechnology. In light of the importance of the Working Group's responsibilities, parties with a stake in biotechnology regulation will want to monitor and potentially assert themselves in both the Working Group and any future rulemaking processes, potentially beginning as early as this fall's public meetings.

  1. Those interested in receiving updates on the Working Group's progress or in participating in the public meetings can sign up here:


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