This group concluded that a consensus would be required on these terms as important tools with harmonization potential for regulatory criteria ( ILSI Brasil, 2018). In September 2018, a workshop facilitated by the International Life Sciences Institutes in Argentina and Brazil discussed the practice of the risk assessment of GMOs in Latin America and identified that the terms “familiarity” and “HOSU” were not clearly defined or were not consolidated as a concept in the literature or guidelines. The concept of familiarity involves knowledge and experience that can be used for risk analysis and helps to identify if and what additional knowledge is really needed therefore, it is not equivalent to safety ( Constable et al., 2007). Regarding the food and feed safety assessment of GMOs, the Codex Alimentarius issued specific principles a decade later that constitute the global standard reference ( Codex Alimentarius, 2003). The Organisation for Economic Co-operation and Development (OECD) was among the first to articulate some of the core principles of familiarity for environmental risk assessment of genetic modified organisms (GMOs) in the Blue Book, back in 1986 ( OECD, 1986) and later ( OECD, 1993), the basic principles for environmental risk assessment were consolidated and globally accepted to this day. The concepts of familiarity and history of safe use (HOSU) are an integral part of problem formulation, as the availability of existing information is a critical element that adds to the weight of evidence. It presumes the formulation of risk hypotheses, which in turn are shaped by previous experience and knowledge and will be tested against available data ( Wolt et al., 2010). Problem formulation determines the risk assessment purpose and scope, guiding the gathering of information and data. It was originally described in the Environmental Protection Agency’s Framework Report ( Norton et al., 1992 EPA, 2014) as a conceptual model that considers the values to be protected, the data needed, and the analyses to be used. Problem formulation has been defined as the “formal, structured, opening stage” of the risk assessment ( Patton, 1998).
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However, as science moves forward, new developments and knowledge make it necessary to periodically update and/or adjust these criteria ( Borges et al., 2018). 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. 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. 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. The session held at ISBR 15th elaborated on the familiarity concept and derived tools and their role in the evolution of risk evaluation criteria. 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.
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 concepts of familiarity and history of safe use are an integral part of problem formulation.
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. 5University of Buenos Aires and International Life Sciences Institute, Buenos Aires, Argentina.4Bayer Crop Science and International Life Sciences Institute, Buenos Aires, Argentina.3Federal University of Espírito Santo, Vitoria, Brazil.2Canadian Food Inspection Agency, Ottawa, ON, Canada.1Embrapa Environment and International Life Sciences Institute, São Paulo, Brazil.Capalbo 1, Phil Macdonald 2, Patricia Machado Bueno Fernandes 3, Clara Rubinstein 4 and Carmen Vicién 5*