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100 Percent Containment Required for Biotech Pharmaceutical and Industrial Products

March 25, 2004

CONTACT: Jim Bair, NAMA Vice President
202.484.2200, ext.107
jbair@namamillers.org

WASHINGTON, D.C. – March 25, 2004 – In comments sent to the U.S. Department of Agriculture (USDA) on March 22, the North American Millers’ Association (NAMA) stressed the significant difference between biotech plant-made pharmaceuticals and industrials products and products intended and approved for food and feed use. Plant-made pharmaceuticals and industrial products are not intended for food and feed use, and are not required to seek food and feed approvals. Therefore, their presence at any level is currently not allowed in products meant for consumption by humans or animals.

“Based on the current tolerance level of zero for pharmaceutical crops, a system guaranteeing 100 percent containment is absolutely necessary. Our customers and consumers expect nothing less,” stated John Gillcrist, President of Bartlett Milling Company and NAMA Chairman.

Current confinement systems for controlling the seed, pollen and output of plant-made pharmaceuticals and industrial products cannot control 100 percent of the genetic material of the newly developed organism or prevent deliberate evasion of the security protocol.

The risk of adulteration from genetic material not approved for food and feed entering the food chain is unacceptable. Preventing such adulteration is the responsibility of the technology developer and the U.S. government because the prevention of such adulteration is totally within their control.

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 an effective regulatory system for plant-made pharmaceuticals. Any modifications would be contingent upon either the establishment of a reasonable Adventitious Presence (AP) policy or approval for food and feed use for each individual plant-made pharmaceutical and industrial product in the U.S. and its major markets.

NAMA has 46 member companies operating 170 wheat, corn, oat and rye mills in 38 states and 150 cities. The aggregate production capacity of NAMA’s membership is more than 160 million pounds of product daily, which is about 95% of the total U.S. capacity.

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NAMA’s comments and recommendations are at http://www.namamillers.org/oldsite/cs_biopharm_Comments_Mar04.html.

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