Unfounded allegations against scientific assessment authorities
In the European procedure for the approval of glyphosate, Germany as the rapporteur member state carefully reviewed and assessed in its report the legally prescribed studies of the applicants, along with all other available and relevant studies in accordance with the legally established methods. It is customary and recognised here that, after critical evaluation of the original studies, the assessment authorities also integrate passages from submitted documents into their assessment reports. This is the reason why parts of Germany's assessment report also contain text passages from study reports andsummaries of publicly available literature, all of which had to be submitted by the applicants as part of the legally required dossier. This general procedure, which is acknowledged as standard both nationally and internationally and which has been established not only for plant protection products but also for pharmaceuticals, biocides and chemicals has met with criticism in the case of glyphosate. "We respect and appreciate the role of associations, organisations and the media to critically appraise the work of scientific authorities. It is an important element in a democratic system," remarks BfR President Professor Dr. Dr. Andreas Hensel. "It is of no benefit to the public discourse, however, if science is discredited on the basis of a lack of knowledge of national and international legal procedures. Nowadays, scientific assessments are only accepted in various circles if the findings support their own agenda. This is precisely the reason why the BfR was founded as an independent and impartial institution for scientific political consultancy." The repeated demand that assessment authorities should conduct their own experiments is not provided for either in the legally prescribed processes.
The BfR made its assessment of glyphosate according to legal provisions. Other German authorities - the Julius-Kühn Institute (JKI), Federal Environment Agency (UBA) and Federal Office of Consumer Protection and Food Safety (BVL) - also prepared their input for the Renewal Assessment Report (RAR) on the basis of the applicants’ dossier. This RAR was submitted to the European Food Safety Authority (EFSA) as the coordinating authority for the subsequent procedural steps. The EU active substances approval procedure stipulates that the RAR is revised after public consultation and scientific evaluation by experts of all EU member states before being adopted and published by EFSA. The more than 450 other plant protection product active substances approved to date in the EU were also subject to this procedure.
The sole criterion for the consideration of study results is the scientific quality and evidence of the studies. Possible interests of the commissioning party, politics or other interest groups can and may not play a role in a scientific assessment. This means that an expert review with sources submitted by applicants from industry (Glyphosate Task Force) is part of the legally binding assessment procedure.
In the legal procedure for the human health assessment of plant protection products, biocide products, pharmaceuticals and numerous other chemicals, it is prescribed that manufacturers must conduct a defined spectrum of experimental tests at their own expense. In conjunction with these studies, a summary dossier must also be submitted to the assessment authorities. Here, test guidlines (e.g. those of the Organisation for Economic Cooperation and Development, OECD), quality assurance measures (e.g. good laboratory practice, GLP) and internationally recognised standard toxicological methods must be taken into account. In addition, publicly available scientific literature must also be included and reported in the authorities’ assessment reports. The legally prescribed processes stipulate that assessment authorities are not to conduct any experiments of their own. The BfR did not in any way subscribe to the point of view of the applicant’s and their interpretation of the corresponding studies without criticism and verification, as has been claimed by certain parties with regards to glyphosate.
Following their own assessments using established, internationally recognised, standard toxicological methods, all assessment authorities in Europe and worldwide who had access to these original data have also reached the conclusion that glyphosate should not be classified as carcinogenic based on current knowledge.
- The European Food Safety Authority (EFSA) as well as experts from the risk assessment authorities of the EU member states
- The United States Environmental Protection Agency (EPA)
- The Canadian Pest Management Regulatory Agency (PMRA)
- The Australian Pesticides and Veterinary Medicines Authority (APVMA)
- The Japanese Food Safety Commission
- The New Zealand Environmental Protection Authority
- The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
- The European Chemicals Agency (ECHA)
About the BfR
The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.
The BfR is celebrating its 15th anniversary this year. To mark the occasion, the institute has published a jubilee brochure (in German) which can be downloaded or ordered free of charge at http://www.bfr.bund.de/en/publication/brochures-61045.html.
This text version is a translation of the original German text which is the only legally binding version.