NAMA
Comments submitted March, 2004
March 22, 2004
Docket No. 03-031-2
Regulatory Analysis and Development
PPD, APHIS, Station 3C71
4700 River Road Unit 118
Riverdale, MD 20737-1238
Re: Docket No. 03-031-2
Dear Madam/Sir:
These comments are submitted in response to the January 23, 2004 Federal Register notice of intent to prepare an environmental impact statement (EIS) and proposed scope of study published by the U.S. Department of Agriculture (USDA)'s Animal and Plant Health Inspection Service (APHIS).
The North American Millers' Association (NAMA) has 45 member companies operating 169 wheat, corn, oat and rye mills in 38 states and 150 cities. NAMA members produce more than 160 million pounds of products each day, or more than 95% of the total U.S. capacity.
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:
• 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.
• Consideration be given to prohibiting the use of food crops, especially corn, to produce plant-made pharmaceuticals. The reasons given for using corn to produce pharmaceuticals include the fact that, relative to other plant options, corn produces a larger quantity of product per acre, corn grain can be stored for long periods of time, and corn's cost of production is lower. As these are economic, not scientific, considerations they are of no relevance in assessing risk or creating regulatory policy.
• 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.
• 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 food production system, and appreciates any consideration that you may give them.
Sincerely,
James A. Bair
Vice President
Read more:
NAMA statement on the Use of Food and Feed Crops for the Production of Plant-made Pharmaceuticals and Industrial Products
News Release - NAMA Calls for Tight Regulation of Plant-Made Pharmaceuticals
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