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Glyphosate assessment: BfR rejects plagiarism accusations

34/2017, 20.09.2017

The BfR reviewed independently all original studies of the applicants as well as publications from the scientific literature in the RAR and the corresponding addendum.

Individual reports in the media have accused the German Federal Institute for Risk Assessment (BfR) of copying significant portions of its assessment of glyphosate from the dossier of the applicants and including them in the German assessment report on the renewed approval of glyphosate as an active substance in plant protection products - and of doing so uncritically without any review for plausibility and scientific correctness. The BfR vigorously rejects these accusations. "This is yet another attempt to call into question the credibility of the scientific institutions who are tasked with assessing the health risks of active substances in plant protection products like glyphosate", says BfR President Professor Dr. Dr. Andreas Hensel. "The dossiers submitted in the statutory assessment procedure are compilations of existing studies and do not therefore constitute an original scientific work themselves."

Both in Europe and worldwide, it is a standard and recognised practice in assessment procedures not only in the area of plant protection products for assessment authorities to also integrate relevant passages from submitted documents in their assessment reports following critical review.. The subdocuments of the assessment report therefore also contain text passages of this kind from publicly available literature sources that were submitted by the applicants as part of the legally required literature research. This is also evident from the headings of the various chapters and sections. The overall assessment of the authorities contains not only the independent assessments but also always includes summaries of scientific insights obtained from original studies and literature publications. The latter are reviewed in depth by the experts of the BfR with regard to their quality and relevance as well as the recorded experimental findings in order to determine their possible significance for the issue of health. "These summaries of published studies are necessarily part of the submitted documents", adds BfR President Hensel.

The statutory procedure for the health assessment of plant protection products, biocide products, medicinal products and numerous other chemicals stipulates that a manufacturer must conduct a prescribed range of experimental tests at his own cost. In addition to conducting these studies, he must also submit a summarised dossier to the assessment authorities. This dossier must take account not only of testing regulations (e.g. those of the Organisation for Economic Co-operation and Development (OECD)) and quality assurance measures (e.g. Good Laboratory Practice (GLP)) but also of established, internationally recognised standard toxicological methods. In addition, freely accessible scientific publications must also be included in the assessment reports and outlined in excerpts. In line with the procedures stipulated by law, the assessment authorities do not conduct their own experiments.

The German Federal Institute for Risk Assessment (BfR) conducted its assessment of glyphosate in accordance with the statutory stipulations and the national, European and worldwide conventions. Based on these same conventions, the other German authorities - the Julius Kühn Institute (JKI), the Federal Environment Agency (UBA) and the Federal Office of Consumer Protection and Food Safety (BVL) as the coordinating agency - made their assessments available to EFSA based on the dossier of the applicants. This procedure was also followed everywhere in the EU in the same way for all of the other 450-plus active substances in pesticides that have been approved to date.

The German Renewal Assessment Report (RAR) on glyphosate was only a preparatory assessment for the European Food Safety Authority (EFSA) and reviewed all the submitted original studies. It constitutes a report by Germany as Rapporteur Member State and was incorporated into the Community assessment by the authorities of the EU member states who are responsible for risk assessment. This report was then further reviewed based on comments submitted in a public peer review process and then thoroughly reviewed, commented on and discussed in depth once again by EFSA and experts of the competent authorities of the member states.

After the International Agency for Research on Cancer (IARC) published its monograph in 2015, the BfR once again critically reviewed this assessment in an addendum as part of the RAR by once again examining the original studies.

It was not the RAR but the BfR addendum to the IARC report that then, as the German authority assessment, formed the central basis for the assessment of carcinogenicity and mutagenicity. This addendum was in turn discussed with all member states as well as with IARC, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), the Environmental Protection Agency in the United States (US-EPA) and the European Chemicals Agency (ECHA) in an expert meeting. The outcomes of these deliberations then formed the basis for the EFSA Conclusion.

Following completion of the risk assessment of glyphosate by EFSA in the procedure for the renewal of approval for the active substance, the BfR prepared a further assessment report for ECHA which used different templates than those used in the RAR and had to satisfy the assessment principles of hazard evaluation for classification and labelling. This report was also commented on by all member states and the public, explained in two hearings at ECHA and supplemented by additional statistical and epidemiological research of ECHA before finally being forwarded to the ECHA risk assessment committee (RAC) for deliberation.

In other words, the BfR in no way adopted the perspective of the applicants and their interpretation of the corresponding studies uncritically and without review, as claimed by various reports in the media. On the contrary, the BfR deleted numerous passages from the submitted documents where these passages contained statements that were not scientifically valid or false statements on the reviewed original studies. Statements and interpretations that were not accepted were then replaced or supplemented by the BfR with its own statements based on its own assessment. When the applicants cite studies correctly or interpret these studies correctly from a scientific and methodological perspective in their corresponding summaries, the European assessment authorities have in the past had no cause to rewrite these statements in the numerous authorisation and approval procedures for plant protection products, chemicals and medicines.

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.

These authorities include:

• The European Food Safety Authority (EFSA) as well as the experts and risk assessment authorities of the EU member states
• The Environmental Protection Agency (EPA) in the USA
• The Canadian Pest Management Regulatory Agency (PMRA)
• The Australian Pesticides and Veterinary Medicines Authority (APVMA)
• The Japanese Food Safety Commission
• The EPA in New Zealand
• 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.

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