Writing in the Journal Frontiers in Bioengineering and Biotechnology, two Argentina-based ILSI researchers, alongside a scientist from the National University of Asuncion in Paraguay, outlined recommendations on how GM crop risk assessment can be improved in developing countries.
The assessment was based on findings from a World Bank-funded, three-year project led by the ILSI between 2011-2014 that looked into biosafety risk assessment and regulation in eight developing countries: Bangladesh, Vietnam, Kenya, Tanzania, Uganda, Colombia, Paraguay, and Uruguay.
Overall, the researchers said that in such countries, there was a “lack of formal process” and “lack of experienced professionals” when it came to monitoring the environmental and human health risks of GM crop production. Whilst a number of government-backed and non-governmental capacity building initiatives had been introduced across these countries, they said more needed to be done.
“A shortcoming of many of these capacity building programs (...) is that while they do help with the understanding of the basic scientific criteria and internationally accepted approaches to risk assessment, the analysis of reference documents and the practical use of these tools to case studies, they do not provide the continued support needed to establish, adopt and then implement these systems in country over time.”
Dedicated, trained risk assessors and independent regulators
The researchers said these capacity building programs had to be long-term and on-going to establish dedicated professionals who could work in the field, as well as tailored to specific country needs.
“Risk assessment is a dynamic, scientific exercise that requires significant technical capacity... Biosafety systems deal with evolving concepts and technologies and need to anticipate and adjust their procedures and requirements to these advances. Therefore, a periodical revision of regulations and operations is always necessary. These processes require to be accompanied by permanent training cycles for risk assessors, which consider state of the art criteria and methodologies.”
However, in most countries, they said there were no formal specialization options so professional risk assessors were formed simply through practice and experience which took time. This, combined with high job rotation and the lack of 'in-house' training proved challenging, particularly in developing countries.
Workshops, courses, conferences and symposia were one valuable way to “raise awareness” and “catalyze discussions” to improve programs, they said, but only continued engagement led to professional, expert bodies. Introduction of academic programs was another way industry could provide a formal context to develop capacities, they said, along with biosafety, risk science and regulatory sciences being taught at high-school.
All of this, though, needed the full support of regulatory authorities and governments and the biggest impact could be made by establishing and funding professional, independent regulatory bodies. This, the researchers said, would enable “self-sustaining systems” that didn't rely on sporadic funding and could be maintained long-term.
“It takes time to design regulatory frameworks and to develop expertise to put them into practice and conduct periodical updates. This is an everlasting process and as technologies and frameworks evolve, regulators need to be prepared to keep up with these changes in a dynamic and continuous cycle. As valuable as the efforts made by diverse organizations might be, these will fail to build sustainable systems without country policy decisions to support the development of dedicated, professional and transparent regulatory bodies that can focus on the high responsibility of protecting environmental and human health.”
Paraguay – a case study
Paraguay – one of the eight countries in the collaborative three-year project – first had its agricultural biotech regulated in 1997. It joined the project following a recommendation from the National Agricultural and Forestry Biosafety Commission (CONBIO), set up in 2012 to access, analyze and issue recommendations on all matters related to GM crops, that said Paraguay needed to update its existing framework around GM crops.
The purpose of being involved in the program, the researchers said, was for countries to improve technical capacities around biosafety risk assessment and regulation, further strengthening institutional governance of agriculture biotechnology through a science-based approach.
In Paraguay, seven seminars and workshops were conducted by 18 expert trainers during the project, both in the classroom and on the field, and online tools, documents and e-learning courses were made available through the projects website. The researchers said the e-learning aspect was extremely valuable and could be used on a global scale in other countries, delivering continuous or as-needed training at low cost to multiple audiences. “Once developed, such a curriculum can be released as a stand-alone program for the training of governmental risk assessors or used as accredited components in graduate degree programs in biosafety, at minimal cost to the government or university,” they said.
Since the completion of the project, CONBIO had issued science-based guidelines and application forms for the experimental release in confined field trials, currently being held on private land, and for the commercial authorization of GM crops, the researchers said. Program partners had also implemented periodical follow-up meetings and special sessions to discuss topics or update risk assessors on new information and developments.
“One of the factors that contributed to this program's success was the collective action, as researchers, regulators, professionals and technicians from the CONBIO, ILSI Research Foundation and ILSI Argentina worked closely and fruitfully in the implementation and follow-up of the program.” Universities and non-governmental organizations were also involved.
However, whilst the program in Paraguay was successful in many ways, the researchers said there remained “numerous difficulties”, including the fact members were not “fully dedicated to risk assessment”, with other responsibilities in their job roles.
Paraguay, they said, now needed the resources from relevant authorities to maintain staff, formal training, and inter-agency collaboration – the case for any developing country upscaling GM crop production.
Source: Frontiers in Bioengineering and Biotechnology
Published online: doi: 10.3389/fbioe.2018.00040
“Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems”
Authors: Fernández Ríos D, Rubinstein C and Vicién C (2018)