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North American Millers' Association Calls for Tight Regulation of Plant-Made Pharmaceuticals

February 7, 2003

Washington, DC – In comments sent to the Food and Drug Administration (FDA) on February 7, the North American Millers’ Association (NAMA) stressed the need for tight regulation of plant-made pharmaceuticals to assure 100% containment from the food and feed supply. NAMA commended the FDA and USDA for issuing the guidance on plant-made pharmaceutical production thereby beginning the process of looking at the system and controls necessary to govern a new technology that promises major benefits and at the same time creates new risks for domestic agriculture.

“It is important to realize that there is a difference between plant-made pharmaceutical crops and other biotech crops tested and approved for food and feed use by the FDA and USDA,” according to John Gillcrist, President of Bartlett Milling Company and NAMA Chairman. “Based on the current tolerance level of zero for pharmaceutical crops, a system guaranteeing 100% containment is absolutely necessary. Our customers and consumers expect nothing less.

NAMA contends that an overall regulatory framework needs to be established with FDA and USDA collaboration that would include mandatory rules, strict compliance and enforcement monitoring, and penalties. NAMA provided several recommendations that it believes should be the basic framework for any effective regulatory system for plant-made pharmaceuticals.

“NAMA’s primary concern is the safety of the food supply,” said Mr. Gillcrist. “NAMA will continue to insist on a system that meets a zero tolerance level. We will continue to work with the FDA and USDA to create a regulatory system that will accomplish this goal.”

NAMA has 45 member companies operating 170 wheat, corn, oat and rye mills in 38 states and 150 cities. Its membership represents about 90% of the total U.S. capacity.


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