Regulatory Analysis and Development
4700 River Road Unit 118
Riverdale, MD 20737-1238
RE: Docket No. 04-041-1
The Organic Trade Association (OTA) is a membership-based organic business association with over 1400 members, representing all sectors of the organic industry throughout North America.
OTA strongly opposes the introduction into open-air planting systems of organisms altered through genetic engineering to produce pharmaceutical products. Furthermore, OTA strongly opposes the use of food species to carry such organisms altered through genetic engineering.
Allowing the open planting of agricultural organisms genetically engineered to produce pharmaceutical substances should be of grave concern not only for organic producers but for conventional agricultural producers as well. USDA is only beginning a process to produce an environmental impact statement for genetically engineered (GE) crops. Problems with contamination of neighboring crops have been widespread, both for wind-pollinated and self-pollinated plants. Gene transfer in open agricultural systems is still poorly understood, but it is clear that gene flow is common rather than rare.
OTA has not seen any evidence that either containment protocols or the enforcement of the implementation of such protocols are sufficient to prevent the spread of these organisms altered through genetic engineering to produce pharmaceutical products into conventional crops.
The potential for economic loss to both conventional and organic corn producers is great, as Japan and Europe both have strict requirements for food not to be contaminated with genetically engineered varieties.
OTA requests that APHIS only allow experimental trials of organisms altered through genetic engineering to produce pharmaceutical products to be conducted in closed systems, and to involve only plants that are not also consumed in any form by humans.