Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems

Abstract

The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. The lack of formal processes that ensure continuity in the application of state of the art scientific criteria, the high rotation in some cases or the lack of experienced professionals, in others, is a challenge to be addressed. Capacity building initiatives with different approaches and degrees of success have been implemented in many countries over the years, supported by diverse governmental and non-governmental organizations. This document summarizes some capacity building experiences in developing countries and concludes that risk assessors taking ownership and regulatory authorities fully committed to developing and retaining highly qualified bodies are a sine qua non to achieve sustainable systems. To this end, it is essential to implement “in-house” continuing education mechanisms supported by external experts and organizations, and inter-institutional cooperation. It has to be noted that these recommendations could only be realized if policy makers understand and appreciate the value of professional, independent regulatory bodies.

Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops

“…Through this partnership, ILSI developed a capacity building program for Paraguay, based on feedback received from Paraguayan government representatives and stakeholders in agricultural biotechnology. Suggestions and recommendations from participants were also incorporated along with the implementation phase of the program ( Fernández Ríos et al, 2018 ).…”

“…Regarding the activities, they “included building a knowledge base focused on developing effective skills on Problem Formulation for ERA of GE crops with a hands-on approach; analysis on key elements and procedures of a regulatory system for confined field trials for each stage in the development cycle of a GE crop; special considerations to the cases of non-target organisms and stacked event crops and safety assessment of foods derived from GE plants” ( Soerensen et al, 2014 ). Seminars and workshops on agricultural biotechnology aimed at a wider, interested audience, and specific working sessions for regulators, scientists and graduate students directly involved in risk assessment activities, with in-depth discussions of risk assessment concepts and tools, using a hands-on methodology were organized ( McLean and Roberts, 2015 ; Fernández Ríos et al, 2018 ).…”

Roads Forward for European GMO Policy—Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform

“…Both these assessment procedures have been scientifically supervised and evaluated. The procedure of environmental risk assessment has been criticized repeatedly for leading to results that are not comparable, as no common test protocol is implemented (e.g., Hilbeck and Otto, 2015; Priesnitz et al, 2016; Fernández Ríos et al, 2018). Moreover, it has recently been suggested to adapt the methods of risk assessment for new types of GMOs (Duensing et al, 2018).…”

Scientific Innovation for the Sustainable Development of African Agriculture

“…Ten countries (Algeria, Botswana, Madagascar, Mali, Namibia, Niger, Senegal, Togo, Tunisia, and Zambia) have a law in place that has not yet been applied through field trials or other activities (ISAAA, 2017). Several countries with a biosafety law in place need a capacity-building effort to strengthen the responsible governmental bodies for better implementation of biosafety programs (Adenle et al, 2018;Fernández Ríos et al, 2018). Indeed, the implementation of a functional biosafety system requires consultation with applicants, expertise to perform science-based risk assessment, risk management, and fast-tracking procedures.…”