         | 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.
- 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.
DETAILS OF ADMINISTRATION INITIATIVES
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.
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