Testimony of a Consortium of 
11 Scientific Societies before the
House Committee on Appropriations Subcommittee on VA-HUD and 
Independent Agencies

April 21, 1998

Chairman Lewis, and Members of the Subcommittee, thank you for allowing me to present testimony today. I am Jerome B. Siebert, Ph.D., Extension Economist in the Department of Agricultural and Resource Economics at the University of California, Berkeley. I appear today on behalf of a scientific consortium made up of eleven scientific societies. A list of these scientific societies is attached to my testimony. The scientific consortium was formed to respond to a proposed rulemaking by the Environmental Protection Agency (EPA) that we found scientifically and economically unsound. This unprecedented coordination resulted in a report analyzing the EPA's proposed rule, and recommending scientifically and economically sound and responsible methods to oversee the use of biotechnology. The report is also attached to my testimony to be entered into the record.

EPA's proposed rule would assert jurisdiction under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) over all substances that plants produce to protect themselves against pests and diseases, as well as the genetic materials necessary to produce these substances. This vast declaration of jurisdiction is analogous to FDA asserting jurisdiction over the human immune system. EPA's proposed rule declares that the genes that protect plants are "pesticides" that require regulation under FIFRA. New plant materials developed through more "traditional" plant breeding practices would be exempted from registration requirements, but plant materials developed through biotechnology Generally would be subject to registration.

Declaring that all plant-defense systems are pesticides, and requiring the registration of the plant-resistant systems acquired through biotechnology, concerns the eleven scientific societies for a number of reasons. First, there are grave concerns that development of new plant varieties through biotechnology would be greatly discouraged. The registration requirements would create a major barrier to market entry. Such a barrier would be prohibitive to the entrepreneurs, college laboratories, and small businesses that have been instrumental in the advances made in this field. In addition, it would render uneconomical the promising efforts to develop resistance characteristics to address a variety of minor crop pest and disease problems. The end result is that farmers and ranchers who would be denied the benefits of new developments would see their costs increase and productivity slowed significantly, if not decreased. The ultimate loser would be the consumer, who would see higher prices, a possible decrease in quality, and a possible decrease in choice.

Second, this proposed rule would result in the continued use of and perhaps an even greater dependence on chemical pesticides. EPA, under the Food Quality Protection Act of 1996 (FQPA) will be undertaking the largest and most comprehensive regulatory review of pesticide tolerances ever undertaken. Reassessment of 9,728 existing tolerances is scheduled over the next several years. The outcome of this process could endanger the continued use of many minor crop pesticide products, especially important to California agriculture, the leading, agricultural state. The alternatives to many of these pesticides are the products of biotechnology. Plant resistance to pests and diseases offers the strongest potential to reduce the use of chemical pesticides. The National Academy of Sciences and the World Health Organization have endorsed the development of new plant varieties through biotechnology and have determined that there is no increased risks in the use of biotechnology as compared to conventional methods of breedina This determination goes hand in hand with a third concern-that the proposed rule is not based on demonstrated risks and toxicity of the genetic substances. Instead the proposed rule would classify all resistant substances as "plant-pesticides" regardless of how harmless or benign the substance is. Economic studies by David Zilberman and others at the University of California have demonstrated that regulations that impose complete vs. selective bans on chemicals, are inefficient in that they do not discriminate between major and minor crop cost increases compared to the benefit that they are attempting to achieve (The Economics of Pesticide Use and Regulation, Science, vol. 253, 2 August 1991, pp. 518-522). The proposed rule would also result in chemically identical plants being regulated differently, because a plant produced by conventional breeding would not be subject to registration while a plant produced by biotechnology would be subject to registration. This policy focuses on the process, and not the characteristics of the biotechnology product. Such a policy is incoherent and directly contrary to the risk-based, scientifically sound approach to oversight of biotechnology required of federal agencies by the Office of Science and Technology Policy, 57 Fed. Reg. 60753 (Feb. 27, 1992).

California has a special and particular problem with the respect to the proposed regulation. While California is the leading U.S. agricultural state, its agriculture is made up of over 250 different crops and commodities, many of which represent more than 90 percent of total U.S. production. It is a highly diversified, specialty, and high value agriculture that also contributes a significant share of the U.S. trade balance in food and agricultural products. It is facing the loss of the chemical based pest and disease control alternatives and is looking towards biotechnology to provide many of the future weapons in its arsenal. The addition of unnecessary costs, which the proposed regulation would impose, would greatly hinder the development of environmentally friendly products.

In addition to these economic impacts, an additional consideration should be noted. This consideration relates to the structure of the agricultural biotechnology industry. Recent mergers and acquisitions have resulted in agricultural biotechnology being placed in the hands of fewer firms. This event leads to lessened competition and control over the research and development agenda by a few firms. Smaller and medium sized firms may find it difficult to compete against the lower cost of capital, economies of scale and marketing expertise of larger firms. Smaller and medium sized firms are needed to fill the niche markets, particularly those characterized by the kinds of commodities produced in California. By EPA's estimate, the proposed regulations would impose substantial new costs on plant breeding ranging from $200,000 to $500,000 on average. This makes it difficult for many firms to justify the cost of developing and registering new plant varieties let alone raise the capital necessary to finance the development.

This situation was best expressed in a letter dated March 7, 1997 to EPA Administrator Carol M. Browner by California's seven-leading agricultural organizations, which states: "By adding substantial new costs to plant breeding, the proposed FIFRA regulations will discourage integration of effective new genetic methods into plant breeding programs. Added costs present potent disincentives to companies whose products target small acreage crops and low profit margins. At the same time, the new regulations would provide no new safeguards that are not already afforded by standard plant breeding practices." This point was also emphasized in an editorial by Len Richardson in the California Farmer Magazine (Mid-January 1997) in which he comments "This attempt to regulate plants as a pesticide will steal your future and push farmers ever closer to full dependence on the few companies that now control plant breeding,, the future applications of biotechnology, and two of your most important production inputs - seeds and crop production chemicals." And if costs of producing food increase due to this regulation, the ultimate payer will be the consumer.

Mr. Chairman, we commend you and your Committee for urging EPA to make special efforts to assure that this rulemaking result in a rule that is scientifically sound, and that the final rule on this subject should enjoy the full support of the scientific community. We ask the Committee to continue your insistence that EPA promulgate rules that make sense scientifically and that comply with federal policy on regulation of products developed throu2h biotechnology. We respectfully disagree with the EPA that FIFRA requires the designation of all plant resistant substances as "pesticides." We submit that EPA can and should work with the scientific community to prepare a final rule that is risk-based, that encourages the use of biotechnology as an alternative to chemical pesticides, and that allows the U.S. to remain the leader in the use of biotechnology in agriculture.

The Consortium

American Institute of Biological Sciences

American Phytopathological Society

American Society for Horticultural Science

American Society for Microbiology

American Society of Agronomy

American Society of Plant Physiologists

Crop Science Society of America

Entomological Society of America

Institute of Food Technologists

Society of Nematologists

Weed Science Society of America

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The American Phytopathological Society