May 3, 2000

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

                    THE WHITE HOUSE
 
               Office of the Press Secretary
 
___________________________________________________________________________
 
For Immediate Release                                         May 3, 2000
 
 
      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.
 
?  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.
 
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This is a mirror of the White House press release, May 3, 2000, from the White House Briefing Room