CLINTON ADMINISTRATION
AGENCIES ANNOUNCE FOOD AND AGRICULTURAL BIOTECHNOLOGY INITIATIVES:
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.
Office of
Science and Technology Policy
1600 Pennsylvania Ave,
N.W
Washington, DC 20502
202.395.7347
Information@ostp.eop.gov
| 
