GMA’s comments were filed in response to proposed guidelines published by the FDA that outline requirements for developing and manufacturing PMPs. In its comments, GMA addressed the need to include clear direction in the final guidelines for maintaining the purity of the U.S. food supply as well. GMA stressed its support for the potential benefits of the technology but said the FDA and U.S. Department of Agriculture must implement more stringent regulations before the technology is more widely used in new field trials approved by the USDA or in large-scale commercialization. GMA’s comments apply to plant-made industrial products as well as PMPs.

“Biotechnology has great potential to bring new benefits to consumers,” said GMA Senior Vice President of Government Affairs Mary Sophos. “However, now is the time to ensure that the appropriate and necessary regulations for PMPs are in place, and that safeguards for the U.S. food supply are implemented before this technology is more widely used.”

“Plant-made pharmaceuticals aren’t meant to make it to the dinner table,” added Sophos. “To minimize the possible risks, a clear system of regulatory enforcement and liability needs to be in place for the development, testing and eventual commercialization of PMPs – just as we require strict regulations for conventional drugs made in brick and mortar facilities. Until then, no permits for new field trials or for commercialization should be issued by USDA because there is no room for trial and error.”

GMA’s comments include recommendations for various procedures to reduce the risk of intentional or unintentional contamination of the food supply by PMPs, including:

• A presumption against the use of food/feed crops for pharmaceuticals unless the company developing the drug product clearly demonstrates that it is not feasible to use non-food crops.
• Additional biological and physical containment procedures such as “terminator gene” technology, the use of large-scale greenhouses and isolation distances need to be considered and utilized.
• Land, labor and equipment dedicated solely to growing PMPs. This extends to carefully selecting and training “pharmers” on the proper handling of PMPs.
• Communication plans and readily-available tests to detect the PMP should be required as part of field permits before allowing any open-air release of PMPs in the case of potential contamination.

GMA plans to work closely with the FDA and USDA as they implement improved regulations for PMPs. Additionally, GMA will maintain an open dialogue with the biotech industry and other stakeholders to ensure that the regulations meet the needs of the evolving technology as well as the needs of the food industry and consumers for absolute confidence in the U.S. food supply.

The comments submitted by GMA were also signed by the American Bakers Association, the Biscuit & Cracker Manufacturers Association, the Food Marketing Institute, the Institute of Shortening & Edible Oils, the International Dairy Foods Association, the National Confectioners Association, the National Council of Chain Restaurants, the National Restaurant Association, and the National Soft Drink Association.

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