Decision Documents

Biosafety decisions typically are recorded in some form of decision document. The documents present key findings of the biosafety review committee and of other parties providing information and advice that collectively form the basis for a final decision to use, or not, a particular GMO in a specified way.

Decision documents prepared by biosafety committees serve to communicate their science-based findings to regulators, applicants, stakeholders, and interested parties. Such reports will:

• Summarize the application

• Note any information missing from the original application and steps taken to provide it to the committee's satisfaction

• Summarize the review process, discussions, and findings of the committee

• Detail the committee's recommendations in regard to their mandate

• Add additional comments (outside the immediate mandate of the committee and the scope of the present application) that regulators or the applicant may wish to consider in subsequent applications

• Outline the conditions under which an approved activity is to proceed, including required risk-management measures, reporting procedures in case of unexpected events, and record keeping

In contrast to the relatively simple safety assessments of field-test applications, requests for large-scale or commercial GMO production and/or marketing are subject to much more extensive review that includes factors such as long-term environmental effects, food-safety assessment, and nonsafety considerations. Accordingly, in addition to the findings and recommendations of the review committee, decision documents pertaining to commercial releases may incorporate:

• Findings and recommendations of the national food-safety committee

• Opinions given by ad hoc scientific experts as requested by the review committee (e.g., ecological studies)

• Findings of outside review teams charged with evaluating the social, economic, and trade impacts of the GMO

• A summary of input from the public

• Any combination of these depending on the structure of the advisory groups and their mandates

Decision documents serve to advise regulators and government officials and inform the public of how a decision was reached. As such, the language should be nontechnical — key words should be defined and all jargon eliminated. For transparency and accountability, documents should be signed by the review committee or competent authority.

Resource Requirements

Scientifically sound safety assessments and measures for handling GM crops, trees, and ornamental species and their products safely require human, financial, and information resources as well as an adequate infrastructure. Below we detail some of the specific resource needs.

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