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Executive Summary

CELL LINE IMPORTATION STREAMLINED PROCEDURES cut the time for testing and approval of such products in half, the Association of Biotechnology Companies (ABC) asserted in a recent press release. ABC said the policy changes' issued June 26 by the Agriculture Dept.'s Animal and Plant Health Inspection Service, will enable firms wishing to about half of what it can now take, required to get such products tested and approved." ABC explained that the changes in cell importation procedures evolved out of negotiations between the Agriculture agency and ABC. The talks were initiated in response to a report from an ABC-sponsored panel of experts selected from the biotech industry. "That report recommended that steps be taken to eliminate testing and paperwork backlogs at USDA's Plum Island. . .testing facility and that cells covered by the law be classified for required testing-according to intended use and degree of potential disease risk to U.S. agriculture," ABC stated. The report was presented to USDA in February. Under the streamlined procedures, ABC said, import applicants "who submit a completed Form 16-3 and technical information questionnaire will be immediately issued a permit for shipment of the foreign biological to the Foreign Animal Disease Diagnostic Laboratory" in Plum Island. Upon receipt of the requisite funds (approximately $2,000 to $3,000 per test) "in vivo and in vitro safety testing will begin immediately," ABC said. "If the biologicals test results are found to be negative, an already prepared importation permit will be immediately mailed from the Plum Island facility to the shipper. The importation application, testing and permit issuance period should not exceed two months." In a June 25 notice to veterinary services, USDA described two classes of cell cultures. Class I cultures are "to be used for the production of products such as vaccines, hormones or other biologicals to be used in livestock, poultry or for commercial distribution," USDA said. They must be safety tested at the Plum Island lab "using susceptible host animals, approved in vitro tests, and/or laboratory animals." Class II cell cultures, USDA noted, are "to be used only for in vitro studies and not to be used in animals other than primates" and may not require safety testing. If no safety testing is required the material may be sent directly to the importer. In ABC's release, assn."General Counsel Bruce Mackler commented that the biotechnology industry "has experienced excessive delays and costs, ranging from 6-18 months and $100,000 per cell line, in importing hybridomas (monoclonal antibody producing cell lines and recombinant DNA modified cells . . . considered candidates for production of important biologicals or drugs." He said "delays in their importation have been very costly and have actually cancelled many important development biotechnology projects."

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