Statement on the Use of
Food and Feed Crops for the Production of
Plant-made Pharmaceuticals and Industrial Products

The members of the North American Millers’ Association (NAMA) recognize the potential humanitarian and consumer benefits of using biotechnology to create industrial, medical or scientifically useful proteins and enzymes in crops, rather than for traditional uses of food, feed or fiber.

NAMA also continues to support the use of biotechnology in agricultural products intended and approved for food and feed use. These products can improve food product quality, safety and sanitation; increase production efficiency; allow more judicious use of agricultural chemicals and help meet growing domestic and world food demand.

NAMA believes it is important to note that plant-made pharmaceuticals and industrial products have significant differences from genetically engineered agricultural products that are intended and approved for food and feed use. Plant-made pharmaceuticals and industrial products are not intended to be cultivated 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.

A positive detection of plant-made pharmaceuticals and industrial products in food or feed at any level, therefore, would require the immediate recall and destruction of all products manufactured from that grain. Under current regulatory standards, this zero tolerance creates an intolerable risk for U.S. food processors.

Current government and industry regulations, procedures and guidelines pertaining to the confinement and stewardship of plant-made pharmaceuticals and industrial products are important in the protection of public health, the environment and food and feed crops. However, NAMA has significant concern that 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.

NAMA believes the risk of adulteration from genetic material not approved for food and feed entering the food chain is unacceptable. NAMA believes that 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.

Recognizing the issues surrounding plant-made pharmaceutical and industrial products and acknowledging that such products are not agricultural crops, NAMA recommends:

• An expansion of current physical confinement system procedures to include a physical separation from all like-commodities or containment under monitored greenhouse conditions, sufficient to guarantee a 100 percent effective isolation from like commodities used in food and feed.

• A temporal separation at pollination based on growing and planting periods. While we have less confidence in the scientific validity of temporal separation, we advocate the redundancy of a separation that assures zero tolerance by taking into account different planting and growing conditions.

• Security procedures that prevent deliberate contamination.

• Mandatory liability insurance coverage to indemnify all downstream traders, handlers, processors and food manufacturers for the full cost of recall, destruction and brand degradation as a result of gene flow or other release of genetic material into the food or feed industries.

• The use of dedicated equipment in all steps of the plant-made pharmaceutical and industrial product manufacturing process including seed production, seed distribution, planting, harvesting, conveyance and storage.

• The creation of USDA/GIPSA validated test methods for the presence of the specific plant-made pharmaceutical and industrial products before approval of field test permits.

• Compliance and enforcement procedures that guarantee a zero level of contamination including the creation of a third party auditing system of compliance.

NAMA believes a procedure for plant-made pharmaceutical and industrial product confinement must include these suggestions to be complete under current regulations. Any modifications to these conditions 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.

Toward this end, NAMA supports the inclusion of all approved plant-made pharmaceutical and industrial products in the U.S. government’s proposal on screening regulations for toxicity and allergenicity for genetically modified material. This would permit AP in trace amounts of initially screened material in the normal commodity stream.

NAMA offers these views in continued support of a strong agricultural system.

Prepared by Jim Bair

Last updated October 2002

– More Information –

• Feb 2003 News Release: North American Millers’ Association Calls for Tight Regulation of Plant-Made Pharmaceuticals
• Feb 2003 Comments to FDA regarding regulatory framework for biopharmaceuticals