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Timothy Willard (202/637-8060), or
Libby Mikesell (202/639-5919)
No Use of Food or Feed Crops for Plant-Made Pharmaceutical Production Without A “100% Guarantee” Against Any Contamination , Says NFPA
(Washington, D.C.) – In comments filed today with the Food and Drug Administration, the National Food Processors Association (NFPA) strongly urged that there be no use of food or feed crops to produce plant-made pharmaceuticals (PMPs) or industrial chemicals “without a 100% guarantee against any contamination of the food or feed supply.”
“In the absence of demonstrated effective controls and procedures to ensure against any contamination of the food or feed supply, NFPA vigorously opposes the use of food or feed crops to produce PMPs ,” noted Dr. Rhona Applebaum, NFPA’s Executive Vice President and Chief Science Officer. “Without such proven and effective controls, applications for this technology should be applied only in non-food and feed crops that are segregated from the food supply.”
NFPA submitted comments in response to FDA’s and USDA’s Guidance for Industry on Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals, issued on September 12, 2002.
“NFPA acknowledges the current and potential benefits of this promising technology,” Dr. Applebaum said. “However, maintaining a safe, wholesome and unadulterated food supply must remain the government’s primary goal, as it is for the food industry.”
Dr. Applebaum stated “FDA has a zero tolerance for articles of food that are not approved for human consumption. Consequently, it is our position that if 100% prevention against adulteration is not achievable, food and feed crops must not be used in the production of PMPs.”
“The issues that should be addressed in both the Guidance and ultimately in regulations should include standard operating procedures (SOPs) for comprehensive treatment of biological containment, physical containment, training throughout the development, production, and processing system, identity preservation, security against intentional efforts to cause food adulteration, monitoring and auditing during field tests and commercialization, waste management and disposal, and accident detection and response including the availability of workable testing methods,” Dr. Applebaum said. “Licensing of individuals involved with various stages of PMP products should also be considered.”
Dr. Applebaum said “USDA must take full advantage of its strong regulatory authority under the Plant Pest Act and related laws to impose permit conditions that will assure containment of PMPs, including appropriate biological and physical containment measures and HACCP controls. USDA must also use its extensive inspection authority, and bolster the inspection resources dedicated to PMPs, to enable the Agency to closely monitor production of PMPs to assure that permit conditions are not violated. In addition, FDA, which has regulatory authority over PMPs as drugs, should make clear that inadequate containment measures will result in withholding approval of a New Drug Applications (NDA) or other sanctions under the Federal Food, Drug, and Cosmetics Act.”
NFPA made clear in its comments that “The food industry is clearly an affected stakeholder in this issue. In a perfect world and if the food industry had complete control of this promising technology from the beginning, we would never have supported the use of food or feed crops for the production of PMPs. The risk of contamination of the food or feed supply is just too great. Unfortunately, PMP technology already has been implemented in food and feed crops.”
Dr. Applebaum concluded “In view of the ‘hand we’ve been dealt,’ the food industry must have a ‘100% protection standard’ against any contamination of the food supply. If this standard cannot be met, we will vigorously oppose the use of food or feed crops as ‘factories’ for pharmaceutical and industrial chemical products. We can demand nothing less for our consumers.”