Washington, DC
May 3,  2001

A Food and Drug Administration (FDA) proposal for a mandatory review process prior to the marketing of new biotech foods will enhance public confidence in the safety and quality of products produced through biotechnology, say the American Crop Protection Association (ACPA) and American Seed Trade Association (ASTA).

Right now, biotech companies consult voluntarily with the FDA before going to market with new
products. In fact, industry has consistently and voluntarily consulted with FDA prior to the
introductions of the approximate 50 biotech food products now in the marketplace. The FDA
proposal would codify the practice. 

"In brief, although no new scientific information exists questioning the safety of [biotech] foods ...
support the development of the proposed mandatory FDA pre-market review process," wrote Jay
Vroom, ACPA president, and Dean Urmston, ASTA executive vice president, in comments filed
today ( http://www.amseed.org or  http://www.acpa.org/public/issues/biotech/testimony/premark.html) 

Although Vroom and Urmston said the voluntary process has worked successfully for years, they
added that the proposed procedures will "appropriately modify" the current voluntary consultation
and enhance the acceptability of biotech foods by improving the transparency of the regulatory
process for the public. In particular, they endorsed the requirement for submitting electronic copies of product review submissions because it would make information available for all stakeholders, including consumers. 

"We believe that providing electronic copies will not only enhance the FDA review process, but also will help make the regulatory process more transparent through availability of online versions in the electronic media, such as FDA’s web site," they said. 

Vroom and Urmston also wrote they endorse the requirement that biotech providers generally
describe the status of their biotech food application with other federal agencies and foreign
governments, but they acknowledged some concerns. 

"While we wholeheartedly continue to support the coordination of modern biotechnology regulation by the different federal departments and agencies, and among different governments, we believe that coordination within the U.S. should be achieved between the departments and agencies themselves, as has been done up until now," they said. "We do not believe, however, that … FDA approval or clearance of a product should be dependent upon the approval, clearance, or authorization by another U.S. or foreign governmental organization." 

FDA’s deadline for comments on mandatory pre-market review comes exactly one year after a May 3, 2000 White House announcement to strengthen science-based regulation and consumer access to information on biotech foods. In addition to mandatory consultations, the White House also encouraged the U.S. Department of Agriculture (USDA) to develop reliable testing procedures and quality assurance programs for differentiating non-biotech commodities. On April 16, 2001, ACPA and ASTA filed joint comments ( http://www.amseed.org or  http://www.acpa.org/public/issues/biotech/testimony/usdarole.html) on the possible development by USDA of marketing standards relating to grains, oilseeds, fruits, vegetables, and nuts produced with or without the use of modern biotechnology.

Organized in 1933, the American Crop Protection Association (ACPA) is the not-for-profit trade organization representing the major manufacturers, formulators and distributors of crop protection, pest control and biotechnology products. APCA member companies produce, sell and distribute virtually all the scientific technology products used in crop production by American farmers.

Founded in 1883, the American Seed Trade Association (ASTA) is one of the oldest trade organizations in the United States. Its membership consists of about 900 companies involved in seed production and distribution, plant breeding, and related industries in North America. As an authority on plant germplasm, ASTA advocates science and policy issues of industry importance. Its mission is to enhance the development and free movement of quality seed worldwide.

ASTA & ACPA news release
N3497