New Food and Agricultural Biotechnology Initatives Anounced

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CLINTON ADMINISTRATION AGENCIES ANNOUNCE FOOD AND AGRICULTURAL BIOTECHNOLOGY INITATIVES:
STRENGTHENING SCIENCE-BASED REGULATION AND CONSUMER ACCESS TO INFORMATION
May 3, 2000

Agricultural biotechnology holds enormous promise for improving the productivity and environmental sustainability of food and fiber production. In order to secure that bright future, the Clinton Administration is taking steps today to further our long-standing goal of sound science regulation and improved access to information. These steps are intended to build consumer confidence, ensure that regulations keep pace with the latest scientific and market developments and provide that voluntary product claims, such as labels, relating to biotechnology are truthful and not misleading.

The Federal Government Has a Strong Regulatory System for Agricultural Biotechnology, a Sector That Holds Enormous Economic and Environmental Promise. The U.S. regulatory approach to agricultural biotechnology applies principles of sound science to ensure that there are no unacceptable human health and environmental risks associated with the use of these crops and that they are safe to enter into commerce. This system, encompassing the food safety and environmental regulations of the Department of Agriculture, Food and Drug Administration, and Environmental Protection Agency, has resulted in rigorous scientific review of products, while providing a predictable regulatory environment that fosters scientific advancement and product innovation.

The Administration's Actions Today Will Strengthen our Science-Based Regulatory System and Facilitate Reliable, Voluntary Labeling Practices. The Administration's actions today will ensure that science remains the cornerstone of our nation's regulatory system --- keeping up with recent advances in genetics, ecology, and health --- and that federal oversight of these products remains strong. In addition, they will facilitate voluntary efforts by producers to differentiate non-bioengineered commodities through the development of accurate and reliable testing and quality assurance procedures and through guidance for the content of product labels.

THE CLINTON ADMINISTRATION ANNOUNCES STEPS TO:

Reinforce the Strength & Transparency of Science-Based Regulation

The Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) will conduct a 6 month interagency assessment of Federal environmental regulations pertaining to agricultural biotechnology and, if appropriate, make recommendations to improve them.

The Food and Drug Administration (FDA) will take steps to ensure that it is informed at least 120 days before new agricultural biotechnology crops or products are introduced into the food supply and will propose that submitted information and the agency's conclusion be made available to the public.

The U.S. Dept. of Agriculture (USDA), FDA, and the Environmental Protection Agency (EPA) will support an expanded program of competitively awarded, peer-reviewed research focusing on current & future safety issues.

Enhance Information for Consumers and Farmers

FDA will develop guidelines for voluntary efforts to label food products under their authority as containing or not containing bioengineered ingredients in a truthful and straightforward manner, consistent with the requirements of the Federal Food, Drug, and Cosmetic Act.

USDA will work with farmers and industry to facilitate the creation of reliable testing procedures and quality assurance programs for differentiating non-bioengineered commodities to better meet the needs of the market.

USDA, FDA, EPA, and the State Department will enhance domestic and foreign public education and outreach activities to improve understanding of the nature and strength of our regulatory process.

Reinforcing the Strength of Science-Based Regulation

The Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) will conduct a 6 month interagency assessment of Federal environmental regulations pertaining to agricultural biotechnology and, where appropriate, make recommendations to improve them.

CEQ and OSTP will conduct an interagency assessment of environmental biotechnology regulations by preparing case studies to identify strengths and potential areas for improvement in the existing regulatory structure. The following agencies will participate in the assessment: Food and Drug Administration (FDA), Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and the Department of the Interior as well as other agencies as appropriate. The focus of this study will be on domestic environmental issues.

The FDA will develop a proposed rule to require companies to notify FDA of their intent to market a new food derived from biotechnology. This new rule would replace the current voluntary, but widely adhered to, practice of consultations with the agency. After reviewing the company's submission, FDA will issue a letter to the firm describing its conclusion about the safety and regulatory status of the food or animal feed.

These three agencies will coordinate their research programs related to risk assessment of agricultural biotechnology and expand these programs, consistent with available resources, in a way that maintains a strong science-based regulatory program. In particular, USDA's research, funded under the Initiative for Future Agriculture and Food Systems, should provide a strong core of competitively funded risk assessment research.

Enhancing Information for Consumers and Farmers

FDA will develop guidelines to help ensure product label claims concerning the biotechnology status of foods are truthful and not misleading. The guidelines will help manufacturers design labeling that is truthful and informative, rather than confusing. The agency will develop draft labeling guidelines with the use of focus groups, and will publish them for comment so as to receive maximum consumer input.

USDA will work with farmers and industry to facilitate the creation of reliable testing procedures and quality assurance programs for differentiating non-bioengineered commodities to better meet the needs of the market.

USDA will develop an Advanced Notice of Proposed Rulemaking (ANPR) to seek input from consumers, industry, and scientists on how best to meet the needs of evolving markets. The ANPR will seek input on current market practice. In addition, it will seek input on the feasibility and desirability of quality assurance programs.

USDA, FDA, EPA, and the State Department will enhance domestic and foreign public education and outreach activities to improve understanding of the nature and strength of our regulatory process.

Using a variety of outreach mechanisms at their disposal, agencies will proactively engage the public on how their foods are regulated and why these regulations protect the environment and human health. This is important both domestically and internationally where U.S. agricultural products are now facing increasing restrictions in some markets, in part due to the lack of shared understanding and information.

One of the most difficult choices a farmer faces each year is what to plant-what type of crops and what specific varieties. Farmers need better market data to better inform their choices. In some cases the current uncertainty in overseas markets concerning biotech corps has made their selections even more difficult. USDA will provide farmers with better information on changes in market access.