GENEWATCH
 
SCRAPPING THE COORDINATED FRAMEWORK
By Alison Peck
 

from GeneWatch 29-1 | Jan-May 2016

The contemporary movement to mandate labeling of foods containing genetically modified (GM) ingredients presents an opportunity to bring the issue of regulation of GM products into the public arena for debate. That debate is important because current federal regulation is based on statutes that pre-dated the technology and were a poor fit for the technology even in the beginning. As the technology has evolved, those statutes don't cover many of the new techniques at all, leaving wide gaps in federal oversight of genetic engineering. A process is now underway to plug those gaps, and citizens should get involved to ensure that the new approach is comprehensive, forward-looking, and responsive to public concerns.

The labeling movement arose out of public dissatisfaction with the stealthy entry of GM ingredients into the food supply. In the 1980s, the executive branch quickly put in place a regulatory framework to govern federal oversight of GM products based on old statutes. Only after GM seed varieties constituted the vast majority of soy, cotton, corn, and sugar beets grown in the United States (94 percent, 90 percent, 90 percent, and 95 percent respectively, according to 2013 estimates) did consumers become aware that nearly all processed foods they were consuming contained GM ingredients. While the labeling movement is useful to focus more public attention on an old problem, the greatest harm resulting from the historic lack of public awareness and discussion of genetic engineering is not to the consumer who wishes to avoid consuming GM foods. Those consumers may already do so by purchasing USDA Organic certified foods, which are not permitted to contain GM ingredients, and by purchasing nearly all varieties of fresh produce and fish, and all varieties of meat, poultry, and eggs, which (at least at present) are not genetically modified.

Instead, the greatest harm from the lack of public awareness of GM regulation is to the consumer who does want to purchase GM foods, but wants to know that they are safe, and to the citizen who wants assurance that GM products will not disrupt the environment. The quick-fix regulatory solution of the 1980s was so poorly suited to the technology that many new GM products using modern genetic engineering techniques now escape important aspects of federal oversight - oversight meant to ensure safety of GM products for health and the environment. To prevent the technology from continually outgrowing federal regulatory authority, the current framework should be scrapped and replaced with a new statute that directly addresses and regulates the unique risks of genetic engineering. 

Some history may help to understand the poor fit between federal regulatory authority and the current state of genetic engineering. When the biotechnology industry was nascent in the 1980s, the Reagan Administration charged its Office of Science and Technology Policy (OSTP) with developing a regulatory framework that would be operational immediately, allowing the industry to bring products to market without the delays associated with drafting, debating, passing and implementing new legislation. The deputy director of the OSTP at that time, Dr. Bernadine Healy, testified at a congressional hearing in 1984 that "one of our major concerns in designing [the regulatory regime] is something that we think would be operational almost immediately." To avoid delay, the Reagan Administration announced the regulatory structure that would govern federal oversight of biotechnology in 1986. The Coordinated Framework for Regulation of Biotechnology divided oversight between three agencies. The FDA's authority is based primarily on the Federal Food, Drug and Cosmetic Act, a 1938 act that authorizes FDA to regulate food additives and misbranding. The USDA's authority stems primarily from a law that dates back to the Federal Plant Pest Act of 1957, which gave the USDA jurisdiction over bacteria and viruses in plants. The EPA derives its authority from the relatively modern pesticide and toxics control laws of the 1970s, including the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act.

The trouble with these statutes is that they do not address the core concerns of genetic engineering: unintended and unidentified consequences to the DNA of the modified plant or animal; potential adverse effects of those unintended consequences on people or animals who consume them; environmental impacts of creating plants or animals that are hard to kill or have a genetic advantage over their wild cousins; and secondary effects on health or the environment from the overuse of pesticides that most GM seeds are designed to withstand. Instead, the regulatory hook for these statutes is, at best, a rough analogy to those core concerns. FDA's authority, for example, was based on its oversight of adulterated foods and food additives - substance (both natural and artificial) added to foods to improve their taste or appearance, such as colorings, emulsifiers, sweeteners and thickeners. Because addition of DNA to an organism didn't seem much like these past examples, it was easier for FDA to enact a presumption that these new components were subject to a statutory exemption for substances that are generally recognized as safe. Moreover, since genetic engineering increasingly involves editing or deleting genes rather than adding new ones, it is unclear that FDA has jurisdiction over these new types of products at all. Similarly, USDA's authority to oversee plant pests gave it jurisdiction over early genetic engineering techniques, which relied on viruses to insert new DNA into an organism. But the virus was never really the problem, and modern genetic engineering increasingly doesn't rely on viruses to do the job at all.

USDA has already announced that it has no jurisdiction over products created with new technologies. In July 2011, USDA informed Scotts Miracle-Gro Co. that USDA had no authority to regulate Scotts' new GM bluegrass. That product was created using biolistics, or a "gene gun," to insert genes, rather than the older method of using a viral vector. In May 2015, USDA acknowledged that it had no jurisdiction over five types of rice developed by researchers at Iowa State University using a new technology called TALEN, which allows developers to edit an organism's DNA rather than inserting anything at all. An even newer technology called CRISPR allows scientists to quickly and cheaply edit genomes, promising an explosion of new GM products in the near future that do not insert DNA, thus evading plant pest and food additive oversight authority by USDA and FDA.

The best way to ensure that federal agencies retain jurisdiction to regulate genetic engineering as the technology continues to evolve is to pass a new law that gives federal agencies jurisdiction to regulate genetic engineering. The decision to avoid a legislative solution in favor of a cobbled-together regulatory framework based on old statutes was not a foregone conclusion in the 1980s and need not be preserved out of lethargy or loyalty. Between 1983 and 1987, at least eight congressional hearings were held investigating the need for new legislation. The Biotechnology Science Coordination Act of 1986 would have amended the Toxic Substances Control Act to provide for a three-level regulatory review of field testing and commercial use of GM products by USDA and EPA. A companion bill was introduced in the Senate. The Omnibus Biotechnology Act of 1990 would have set aside the 1986 Coordinated Framework and given agencies authority to regulate genetic engineering specifically.

Despite the labeling movement, public awareness of GM foods remains low. A 2013 survey by researchers at Rutgers University showed that 54 percent said they know very little or nothing at all about GM foods, and 25 percent still say they have never heard of them. Because most consumers are not aware of GM foods, only seven percent mentioned genetic modification when asked what information they would like to see on food labels. Minimally-informed consumers, however, express concern about GM foods. When asked to rate how important it would be to them to have various kinds of information on food labels, 59 percent said that it was very or extremely important to have information about GM ingredients. Moreover, responses suggest that consumers would be unhappy if they understood their current lack of awareness: Only 26 percent of respondents believed that they had ever eaten any food containing GM ingredients, but 63 percent said they would be upset if they were served GM food in a restaurant without knowing it. Fifty-four percent said they would be willing to pay more for food that was not genetically modified.

Fortunately, and perhaps in part due to the GM labeling movement, the Obama Administration has begun an effort to reconsider the Coordinated Framework. On July 2, 2015, President Obama created an inter-agency task force among USDA, FDA, and EPA to update the Coordinated Framework and develop a strategy to prepare for changes in biotechnology. But tinkering with a framework based on statutes that didn't contemplate genetic engineering or its core concerns will inevitably be inefficient and off-target. Instead, the task force should request new legislative authority that authorizes agencies to regulate genetic engineering and the risks it presents, and concerned citizens should push Congress to enact such legislation.

 

Alison Peck, J.D., LL.M., is Professor of Law at West Virginia University College of Law.


 
 
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