Context for Biosafety Review and Decision Making

Biosafety review — the scientific evaluation of a GMO's potential effects on the environment and human and animal health — is often seen as the single factor that determines whether or not a GMO or product is approved for testing or use. However, safety assessments are conducted within a larger context for decision making that includes national policies for agriculture, biotechnology, and biosafety (or lack thereof), international agreements, stakeholder interests, and public attitudes (see Figure 1).

Factors Affecting Decision Making

Countries individually decide whether to develop, deploy, or use genetically modified organisms and the products made from them. Such decisions take into account national policies for agricultural research and development and the potential role of biotechnology in meeting national goals and objectives in food production, food security, trade, and related areas. Decisions regarding the use of this technology and its products are based, in part, on a determination that they do not pose an unacceptable risk to the environment or to human health.

With the pending entry into force of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol)1 — a legally binding international protocol for the safe transfer, handling, and use of living modified organisms — such biosafety assessments soon will become part of international trade agreements. Other factors not related to environmental or health safety are typically considered in national decisions regarding the use of GM crops, organisms, and the products derived from them. Among these are social and economic considerations, requirements under national law and international agreements, stakeholder input, ethical issues, and impacts on trade. These nonsafety factors, significant in terms of public acceptance, are rightfully considered in decision making by competent authorities. However, this workbook is focused more on the technical aspects of scientific biosafety review; we do not attempt to address nonsafety factors fully here.

Figure 1. Factors governing decisions about the release and use of GMOs. Factors in decisions about the release of a GMO are based in part on safety assessment and necessarily include other considerations as well. Nonsafety issues such as effects on society, economic consequences, and effects on trade are also keys in decision making. Typically, decision making incorporates, whether formally or informally, stakeholder input, public concerns and opinions, existing policies in agriculture, the environment, and food safety and responsibilities under international agreements.

National policies

Stakeholder input

Nonsafety issues

National policies

Stakeholder input

Nonsafety issues

Public opinion

International agreements

National decision making

Public opinion

International agreements

* The focus of this training workbook

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