GMA News Release | USDA BIO-PHARMA PERMIT CHANGES ONLY A FIRST STEP<br> GMA Says Changes Are Insufficient to Ensure Food Supply Safety 3/6/03:


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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 USDAs planned permit changes dont 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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The Grocery Manufacturers Association (GMA) represents the worlds leading food, beverage and consumer products companies. The Association promotes sound public policy, champions initiatives that increase productivity and growth and helps ensure the safety and security of consumer packaged goods through scientific excellence. The GMA board of directors is comprised of chief executive officers from the Associations member companies. The $2.1 trillion food, beverage and consumer packaged goods industry employs 14 million workers, and contributes over $1 trillion in added value to the nations economy. For more information, visit the GMA Web site at www.gmaonline.org

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