Pew Initiative Report Examines Regulatory Review Process for Future Ag Biotech Products

A range of options exists to enhance the regulatory review process to address new challenges future products of agricultural biotechnology are likely to present, although opinions vary about the need for change, according to Issues in the Regulation of Genetically Engineered Plants and Animals, a new report released today by the Pew Initiative on Food and Biotechnology.

The report notes that current agricultural biotechnology products have been widely adopted without evidence of food safety or environmental problems, but the potential complexity of future products may challenge the ability of the existing Coordinated Framework for Regulation of Biotechnology (administered by the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)) to continue to protect public health and the environment and maintain public trust. The report also examines the extent to which agency regulatory practices are transparent, clear, and open to public participation--all procedural elements that will help build confidence in the integrity of the regulatory system. 

"The ability of the current regulatory review system to keep pace with technology and manage the environmental and food safety issues raised by future products has emerged as an important part of the debate over agricultural biotechnology," noted Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology. "By analyzing the strengths and weaknesses of the Coordinated Framework's ability to address future products and identifying a range of options to enhance the Framework, we hope to provide policymakers and interested parties with a unique and valuable resource." 

While the report does not contain recommendations, each chapter analyzes the current legal authorities used by agencies to oversee a particular product, examines the issues future products may raise for that review process, discusses differing policy perspectives and outlines policy options to address those issues. The report finds that: 

• Both the EPA and USDA's Animal and Plant Health Inspection Service (APHIS) face challenges with respect to their ability to manage possible environmental risks raised by genetically engineered (GE) plants APHIS may not have the necessary regulations in place to: (1) comprehensively oversee GE plants that cannot easily be defined as "plant pests"; (2) consider broad environmental risks that may be posed by a GE plant; or (3) quickly and fully manage environmental issues that arise once the plant has been "deregulated" and entered the marketplace. Similarly, current EPA regulations limit the ability of the agency to enforce on-farm planting restrictions developed to reduce the creation of insect resistance to pesticides produced by some GE plants and to protect non-target species. Finally, it appears that both APHIS and EPA have legal authorities that could be used to regulate GE plants used to produce industrial chemicals, but the agencies have not clearly spelled out how or whether such authorities would be coordinated. The report notes a number of options could be used to address these issues, including clarifying the legal authorities and policies of APHIS and EPA through administrative rulings or legislation. 
• FDA lacks the legal authority to require developers to prove the safety of all foods derived from GE plants--including imported foods--before they go to market, which some believe is necessary. Others believe that FDA's current voluntary pre-market consultation program is sufficient to ensure food safety. Additionally, it is unclear how agencies would conduct an early food safety review to assess the potential food safety risks if GE crops grown in experimental field trials were to accidentally mix at low levels with crops intended for the food supply. Options for addressing these issues include using administrative rules to make pre-market notification mandatory; requiring companies to obtain an affirmative finding of safety from FDA before bringing a product to market; and coordinating agency regulation to achieve mandatory food safety review before a GE crop goes on the market. Additional options, each involving various ranges of administrative action and/or legislation, are also discussed. 
• Federal agencies have not addressed how, or if, they intend to regulate GE animals. The report states that should FDA and/or USDA opt to exercise regulatory oversight of GE animals, there are strengths and weakness associated with the legal authorities the agencies are likely to invoke. If FDA were to use the new animal drug provisions under the Food Drug and Cosmetic Act (FDCA) to regulate GE animals, the agency would have a significant level of pre- and post- market authority to deal with food safety, animal health, and some environmental issues related to GE animals, including a mandatory pre market review process that is currently absent for most GE plants. However, the application of new animal drug approval provisions to GE animals raises a number of issues, including a lack of transparency and a question about FDA's legal authority to address the full range of environmental concerns associated with GE animals. Alternatively, FDA could choose to regulate only the food safety aspects of food derived from GE animals. While there are a number of laws that USDA could use to regulate GE animals, none appear to give USDA clear authority to address all of the food safety, environmental and animal safety issues raised by GE animals. Options noted in the report for dealing with these issues include coordinating with other agencies to provide environmental review or using legislation to clarify the authorities of USDA or FDA to conduct more comprehensive reviews of GE animals.

"There is no evidence that products now on the market pose any food safety or environmental problems," concluded Rodemeyer. "But this report identifies areas where regulators may not have adequate legal authority and the full range of tools they need to address the complexities posed by the next generation of products from agricultural biotechnology. Going forward, policymakers will have to consider those issues as well as the options available to improve the system." 

Biotechnology products have been regulated since 1986 according to the Coordinated Framework for Regulation of Biotechnology, a federal policy that directs FDA, USDA and EPA to coordinate the evaluation of biotech products using existing laws including the Food, Drug and Cosmetic Act (FDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). The central premise of the Coordinated Framework is that the process of biotechnology itself poses no unique risks and that products engineered by biotechnology should therefore be regulated under the same laws as other products with similar compositions and intended uses. In January 2004 the Animal Plant Health Inspection Service at USDA announced it would prepare a programmatic environmental impact statement for possible new regulations derived from the Plant Protection Act, which was signed into law in 2000 and could be a first significant step toward overhauling the regulations APHIS uses to govern GE plants. 

ASSOCIATED REPORT: 
Issues in the Regulation of Genetically Engineered Plants and Animals