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.
· USDA will provide farmers with reliable information on markets to inform their planting decisions and with best farming practices for new crop varieties.
 
These Initiatives Reaffirm our Science–Based Regulatory Approach and Improve Public Access to Information.  These initiatives reaffirm the federal government’s confidence in its independent, science-based regulatory approach to agricultural biotechnology.  They also reflect that, as science and industry advance and consumer interest grows, it is appropriate to maintain the strength of our regulatory framework and ensure that information available to the public about the technology and to consumers about food products is balanced and accurate.  In so doing, Americans will be in a better position to realize fully the enormous promise of this technology.

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 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.

· 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.

The U.S. Department of Agriculture (USDA), FDA, and the Environmental Protection Agency (EPA) will support an expanded program of competitively awarded, peer-reviewed research focusing on current and future safety issues to expand the existing body of independent science on biotechnology derived foods.

· 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 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.

· 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.

USDA will work closely with the State Department to ensure collection of timely information on overseas markets, and will provide farmers with reliable information on markets to inform their planting decisions and with best farming practices for new crop varieties.

· 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.

2000 OSTP New Releases

Global Science and Technology Week - May 7-13, 2000

Interagency Report on the Federal Investment In Microbial Genomics

Wellspring of Prosperity: Table of Contents

Pcast Letter on Critical Infastructure Protection

Closing remarks by ROSINA BIERBAUM at the VILLAGE POWER 2000 EVENT

Report Analysis of Facilities and Administrative Costs at Universities

Cuts in Specific Priority Programs

Dr. Neal Lane Releases Mid-Summer Status Report on R&D Appropriations - August 3, 2000

Dr. Lane Awards the 1999 Presidential Early Career Awards for Scientists and Engineers - April 12, 2000

Letter by Dr. Lane to America's S&T Leaders

Food and Agricultural Biotechnology Initiatives: Strengthening Science-Based Regulation

Analysis of Facilities and Administrative Costs at Universities

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