Public researchers’ experiences with GMO regulations

Building on the preceding presentations, Dr. Morandini underlined that genetic modification in plants is a tool with the same goal as conventional breeding: to develop better varieties for farmers, the environment and consumers. As many other tools, genetic modification is neither inherently risky nor safe. GM crops approved to date are as safe as, or safer than, conventional crops and have demonstrated environmental and other benefits. PRRI supports biosafety regulations that allow authorities to make informed and balanced decisions in order to maximize the benefits of biotechnology and minimize risks. Biosafety regulations must therefore be transparent, science based, proportionate and predictable. A PRRI survey shows that public researchers in many EU countries experience that the current regulatory situation often unduly hinders research. This is particularly felt in field research. Field trials are an essential stage in the development of new varieties. Problems are experienced with the EU regulatory system, the way in which the EU system is transposed into national regulations and the way in which EU and national rules are executed in practice. Examples of problems are: Regulations that stay too long in draft form; provisions that are inconsistent with the EU system; restrictions or bans that lack scientific basis; fees that are prohibitive for public research; undifferentiated information requirements; requirements to publish locations of field trials that result in destruction of research; no mechanism for exemptions on EU level; conflicting interpretations and policies between different bodies; requests for additional data that have no basis in risk assessment; ignoring the advice of the scientific bodies such as EFSA; decisions not taken within the legal time frames; disproportionate or unworkable conditions in permits; mandatory insurance, ineffective government action against destruction of field trials. The consequences of these challenges is that research is becoming increasingly expensive due to costs for additional requests for data and for security measures, important research does not get beyond the greenhouse stage, and important research and safety data are often lost because of the destruction of field trials. Consequently, as was illustrated by a number of examples, much needed public research is increasingly and unnecessarily delayed, ended, moved abroad or not started at all. PRRI offers the following recommendations: - EU Member States should adhere to the rules they themselves created, e.g. decisions within the time frames, and based on scientifically sound risk assessment. Scientifically sound means looking at the whole of the scientific data available, not only at hand picked cases. - Additional data should only be requested if they are pertinent to the risk assessment. - Remove unqualified bans from regulations. - Permit conditions should be proportionate to risk. - Environmental benefits should be taken into account. - Establish differentiated procedures. - React effectively to destruction of field trials - When amending the EU regulatory system: Re-introduce mechanisms for simplified procedures and introduce a mechanism for exemption of categories of GMOs that are not likely to have adverse impacts, such as certain pest resistant crops.