FOR IMMEDIATE RELEASE
USDA BIO-PHARMA PERMIT CHANGES ONLY A FIRST STEP
GMA Says Changes Are Insufficient to Ensure Food Supply Safety
Contact:
Scott Openshaw, Director, Communications, 202-295-3957
Brian Kennedy, Director, Communications, 202-639-5994
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.
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Based in Washington, D.C., the Grocery Manufacturers Association is the voice of more than 300 leading food, beverage and consumer product companies that sustain and enhance the quality of life for hundreds of millions of people in the United States and around the globe. Founded in 1908, GMA is an active, vocal advocate for its member companies and a trusted source of information about the industry and the products consumers rely on and enjoy every day. The association and its member companies are committed to meeting the needs of consumers through product innovation, responsible business practices and effective public policy solutions developed through a genuine partnership with policymakers and other stakeholders. In keeping with its founding principles, GMA helps its members produce safe products through a strong and ongoing commitment to scientific research, testing and evaluation and to providing consumers with the products, tools and information they need to achieve a healthy diet and an active lifestyle. The food, beverage and consumer packaged goods industry in the United States generates sales of $2.1 trillion annually, employs 14 million workers and contributes $1 trillion in added value to the economy every year.
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