Recommendations from the workshop on Comparative Approaches to Safety Assessment of GM Plant Materials: A road toward harmonized criteria?

Abstract

An international meeting of genetically modified (GM) food safety assessors from the main importing and exporting countries from Asia and the Americas was held in Buenos Aires, Argentina, between June 26th and 28th, 2013. Participants shared their evaluation approaches, identified similarities and challenges, and used their experience to propose areas for future work. Recommendations for improving risk assessment procedures and avenues for future collaboration were also discussed. The deliberations of the meeting were also supported by a survey of participants which canvassed risk assessment approaches across the regions from which participants came. This project was initiated by Argentine Agri-Food Health and Quality National Service (SENASA, Ministry of Agriculture, Argentina), with the support of the International Life Sciences Institute (ILSI) and other partner institutions. The importance of making all possible efforts toward more integrated and harmonized regulatory oversight for GM organisms (GMOs) was strongly emphasized. This exercise showed that such harmonization is a feasible goal that would contribute to sustain a fluid trade of commodities and ultimately enhance food security. Before this can be achieved, key issues identified in this meeting will have to be addressed in the near future to enable regulatory collaboration or joint work. The authors propose that the recommendations coming out of the meeting should be used as a basis for continuing work, follow up discussions and concrete actions.

Development of a construct-based risk assessment framework for genetic engineered crops

“…vegetatively propagated crops), this framework can aid to perform RA for specialty or ornamental crops, tree species, etc., including the so called “orphan crops”, of regional or local interest (Falck Zepeda and Cohen 2006 ). In this sense, initiatives like inter-agency collaborations, joint reviews or mutual recognition of RA reviews could greatly facilitate the use of this approach, in particular in developing countries (Bartholomaeus et al 2015 ).…”

The Story Behind the Approval of the First Bt Maize Product

“…Currently there are 185 Codex Members and 1 member organization (EU). Most countries with official regulations on genetically modified organisms base their regulations on the Codex requirements (Codex Alimentarius 2003;Privalle et al 2012;Bartholomaeus et al 2015).…”

Use of designer nucleases for targeted gene and genome editing in plants

“…Whether other US federal regulatory agencies such as FDA (Food and Drug Administration) and EPA (Environmental Protection Agency) will rule in a similar fashion to APHIS is unknown, as are the responses of foreign countries. Initial thoughts and opinions in regard to these weighty matters have already surfaced (Nagamangala Kanchiswamy et al ., ; Ricroch and Henard‐Damave, ) and public dialogues (Bartholomaeus et al ., ; http://nabc.cals.cornell.edu/Publications/NewsArchive/NABC-26-Overview.pdf) are underway. If, in the future, the federal regulatory agencies (and perhaps similar agencies of foreign countries) decide to evaluate genetically enhanced plants based not on the process by which they are produced, but rather on whether or not they vary significantly in safety and nutrition from their conventional progenitors, it is possible that the distinction between standard GMOs and crops enhanced with designer nucleases will be of less consequence.…”