Washington, DC
March 6, 2003

Expected changes to the oversight of plant-made pharmaceutical (PMPs) field trials by the U.S. Department of Agriculture represent a small first step in addressing food industry concerns, the Grocery Manufacturers of America said today. But much more needs to be done to ensure the safety and purity of the food supply, according to GMA.

"The USDA's planned permit changes don't go far enough to alleviate the concerns of the food
industry," said GMA Senior Vice President of Government Affairs Mary Sophos. "Regulatory changes should be implemented before new permits are issued. There is no room for trial and error in PMP regulations."

In comments submitted to the FDA earlier this month regarding PMP regulations, GMA said:

• No new field trial permits should be issued until the regulatory structure is completed.
   
• There should be 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.
   
• A clear system of enforcement needs to be established for field trials already underway and for the future commercialization of PMPs.

"GMA recognizes that additional regulatory changes will be made in the coming months. However, to move forward with new PMP field trials without a comprehensive regulatory structure in place is inappropriate and risky," Sophos continued. "GMA will continue to work with all appropriate policy makers to ensure that the right regulatory system for PMPs is implemented."

USDA regulates PMP field trials, and issues permits detailing the conditions under which the experimental crops can be grown. Under its existing regulatory authority, USDA will enforce new field trial permit conditions for the 2003 planting season. Expected changes include: increased frequency of field inspections; mandatory record keeping of how all permit conditions are met; increased distances for buffer zones around PMP field trials; dedicated land and equipment; and, mandatory training of all individuals involved in the field trial on meeting the permit conditions. USDA will announce changes to the permit conditions on Friday; notice of the changes will be published in The Federal Register on March 10.

GMA will submit comment to the USDA regarding the permit conditions, as requested by the USDA. Additionally, GMA and the food industry will continue to work with the appropriate agencies and the biotech industry to develop and implement regulatory changes for PMPs.

GMA is the world's largest association of food, beverage and consumer product companies. With U.S. sales of more than $460 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry. Led by a board of 42 Chief Executive Officers, GMA speaks for food and consumer product manufacturers and sales agencies at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry.