WASHINGTON (November 24, 2004) -- “Today the Food and Drug Administration (FDA) strengthened regulatory oversight of biotech crops with a policy change that benefits consumers, farmers, food processors and grain handlers,” said Dr. Michael Phillips, vice president for food and agriculture, science and regulatory policy for the Biotechnology Industry Organization (BIO). “The Early Food Safety Assessment review ensures that proteins from biotech crops are scrutinized for food safety earlier in the review process. This means consumers can be confident that any proteins from biotech crops appearing in foods, even before receiving final regulatory clearance, are safe.”
The FDA action is in response to a 2002 proposal from the White House Office of Science and Technology Policy (OSTP). At that time, OSTP anticipated that the rapid expansion and adoption of this new food technology, in conjunction with the realities of plant biology, could lead to a strain on seed production and commodity handling systems to meet food and feed safety standards. OSTP urged the federal agencies with biotech crop oversight to develop a science-based system to provide earlier safety reviews. By completing the safety assessment early in the regulatory review process, FDA can ensure that health questions are resolved long before new products enter the marketplace.
Under this new system, product developers will still be expected to complete their consultation with FDA prior to marketing the food or feed, consistent with existing practices. This early food safety assessment applies only to new proteins introduced to food and feed crops, and does not apply to biotech plants intended for pharmaceutical or industrial uses, unless deregulated for general commodity use in food and feed.
In April, BIO and the U.S. grain industry jointly urged the administration to expedite the implementation of an overarching, science-based policy governing incidental, trace amounts – or so-called “adventitious presence” – of biotechnology enhanced events in raw and processed grains and oilseeds, as well as food and feed. The new policy provides safety assurance while recognizing a biological system’s potential to appear in trace amounts at unexpected places through a variety of market realities: biological factors, mechanical mixing, pollen and seed movement, handling, and other transportation related activities.
Phillips hailed this action as crucial to achieving a global approach to agricultural regulatory policies. “Seven million farmers in 18 countries have adopted biotech-improved crops. In today’s global trading arena, there are no geographic borders so FDA’s adoption of this policy today is the essential first step in establishing harmonized international science-based systems to regulate modern agricultural products.”