Abstract
Problem formulation is the formal opening stage of a risk assessment that determines its purpose and scope and hence guides the gathering of information data. The concepts of familiarity and history of safe use are an integral part of problem formulation. These concepts do not replace the case-by-case approach and are not taken as safety standards but are valuable components of the process that shape the generation of plausible, testable risk hypotheses. The International Life Sciences Institutes in Brazil and Argentina have facilitated numerous discussions on the scientific principles for risk assessment of transgenic crops in the Latin American region in the past 5–6 years. The session held at ISBR 15th elaborated on the familiarity concept and derived tools and their role in the evolution of risk evaluation criteria. Examples of how different countries in the Americas interpret and apply these conceptual tools show that familiarity is a valuable concept, although terms are very often confused and vaguely defined. Formalizing these terms with clear definitions and scope of application in guidelines and regulatory documents would reduce ambiguity, enhance predictability, and add transparency to the evaluation processes.
Highlights
Risk assessment criteria for transgenic organisms have been set decades ago and are still current, built on the following: case-by-case, comparative assessment, tiered approach, and consideration of the weight of evidence
Even though neither the Biosafety Law and Decree nor CTNBio’s Normative Resolutions mention the terms “familiarity” or “history of safe use (HOSU)” in the context of risk assessment of genetic modified organisms (GMOs) and their by-products, these concepts are implicit in the assessments performed by its members
CTNBio Technical Decisions have consistently reflected the application of conceptual tools based on familiarity, as data for human and animal health risk assessment performed in other parts of the world are considered
Summary
Risk assessment criteria for transgenic organisms have been set decades ago and are still current, built on the following: case-by-case, comparative assessment, tiered approach, and consideration of the weight of evidence. Familiarity, on the other hand, refers to the body of knowledge (evidence/data) and experience (of use, and with risk assessment) with technologies and products that have undergone a risk assessment process or for which substantial data are available (Figure 1).
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