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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
Transparency at the Animal and Plant Health Inspection Service
USDA has successfully used electronically accessible databases to improve the transparency of its regulatory process and to keep the public and the regulated community informed about changes in regulation. The APHIS Biotechnology Index, on the USDA website (USDA 1999b), provides timely access to a number of databases and other information that assist researchers, companies, and the public in working with and understanding the USDA regulatory program. For example, the Biotechnology Permits Database (USDA 1999c) is updated daily and provides detail on and the current status of recent applications for movement permits, notifications of intended release, and release permits. Other accessible databases linked to the Biotechnology Index include historical environmental releases back to 1987, decision documents (environmental assessments and determinations on nonregulated status), public notices (proposed rules and links to the Federal Register), and summaries of field releases by type of crop, phenotype, and location. Other website resources listed in this index include guidance on applying for permits, making notifications, and petitioning for determination of nonregulated status and a variety of biosafety resource materials. The more traditional method of Federal Register notices to present regulations and convey regulatory decisions is also used. Those around the world who are interested in agricultural biotechnology use the databases maintained by USDA to track applications. Resource limitations, such as funding, can hamper the agency's ability to maintain the databases on those various aspects of the regulatory process. The committee finds the
USDA database on FPPA decisions to be particularly useful and user-friendly.It should serve as a model for the other agencies; the committeerecommends full funding for the maintenance of the existing USDAdatabases.
USDA has identified aspects of data submissions that applicants may declare as CBI. In the preamble to the initial regulations, the agency directed that applicants provide a detailed statement regarding why submitted information should be treated as confidential because of the competitive harm that might result from disclosure (USDA 1987). The agency requests two copies of applications and notifications, one with CBI deleted so that the document can be shared with state coregulators. State regulators have the opportunity to assess the plant-pest risk issues for their state for permits, notifications, and determinations for deregulated