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美国政府科技报告
>Public Research and the Regulatory Review of Small-Market (Specialty) Biotechnology-Derived Crops Workshop. Proceedings. Held in Riverdale, Maryland on November 8-9, 2004.
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Public Research and the Regulatory Review of Small-Market (Specialty) Biotechnology-Derived Crops Workshop. Proceedings. Held in Riverdale, Maryland on November 8-9, 2004.
Specialty crops, which include vegetables, fruits, nuts, flowering plants, nursery stock and other horticultural products, produce approximately 50% of US agricultural crop value (approx $45 billion/annum). A decade after the introduction of genetic engineering (GE) into U.S. agriculture, however, it is clear that the biotechnology revolution is bypassing specialty crops. Relatively few GE specialty crop varieties have been submitted to regulatory agencies for clearance, and most of those that have been approved are not available in the marketplace today. Only one - a disease-resistant papaya - is a commercial success, and it was developed not by the private sector, but by public researchers. The number of products in development has declined rapidly over the last five years, and is approaching zero. Thus the outlook for change is bleak, unless those factors suppressing interest in GE specialty crops are identified and reversed. It is widely understood that large investments of capital in small-market crops may be unprofitable, because of limited sales. A substantial fraction of development costs of GE crops goes to meeting the requirements of the U.S. regulatory agencies to demonstrate safety. Can the regulatory requirements be met by some different approaches that reduce costs but maintain safe products and effective regulation. This two-day workshop was convened to discuss how the public research sector, the regulatory agencies, and the private sector can work together to facilitate the regulatory review of specialty GE crops. The workshop's objectives were (1) to identify major sources of cost and uncertainty in the development of GE specialty crops and submission for approval; (2) to identify research that can help meet these requirements effectively and at minimal cost, without compromising the integrity of the regulatory process; and (3) to learn about existing programs that facilitate commercialization of other regulated small-market products and recommend a model that would be useful for GE specialty crops.
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