The U.S. federal government has established a coordinated, science-based system to ensure that products resulting from biotechnology are safe for the environment and human and animal health. The new "United States Regulatory Agencies Unified Biotechnology Web Site" < http://usbiotechreg.nbii.gov> provides information on the U.S. regulatory process for biotechnology products and access to a database of completed regulatory reviews.
The partnership-driven site, developed with guidance from the U.S. State Department and hosted by the NBII, brings together information from the three federal agencies that share responsibility for regulating agricultural biotechnology in the United States: the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, the U.S. Department of Health and Human Service's Food and Drug Administration, and the Environmental Protection Agency. Depending on its characteristics, a biotechnology product may be subject to review by one or more of these agencies.
The heart of the new Web site is a searchable database, updated regularly, that covers crop plants developed through the use of modern biotechnology that have completed the recommended or required reviews for planting, food, or feed use in the United States. This database lists only products that have completed evaluations by all relevant federal agencies for a particular use. The database may be searched by common or scientific name, trait (insect resistance, herbicide tolerance, etc.), applicant, event, or keyword, including trade name. Each record has product information, including reviewed uses within the United States, and regulatory agency review summaries. Regulatory information for each product, hosted by the agencies themselves, can be accessed through links in the database.
Information on the U.S. site concerning living modified organisms (LMOs) is reported to the Biosafety Clearing-House (BCH). The BCH is an international information exchange mechanism established by the Cartagena Protocol on Biosafety to assist parties in the implementation of the provisions of the Protocol and to facilitate sharing of information on, and experience with, LMOs.
The United States will provide capacity-building support to countries wishing to use the U.S.-developed database and Web site templates to provide access to their own biosafety information. The United States will cosponsor training workshops in conjunction with the United Nations Environment Program?Global Environment Fund Biosafety Clearing-House Project, as well as offer phone and e-mail technical support.
For more information on the U.S. templates and/or capacity-building assistance, e-mail the NBII's Donna Roy at <droy@usgs.gov> or phone 703-648-4209.