Industry reports are routinely part of assessment reports
“It is the remit of politics, NGOs and the media to make inquiries about the work undertaken by authorities,” says Professor Dr. Dr. Andreas Hensel. “However, we often see that the complexity of the conventional procedure for the re-approval of the pesticidal active substances is not understood properly. If people are of the opinion that doubt should be cast on the conclusions reached by the European assessment authorities and European Food Safety Authority concerning the carcinogenic potential of glyphosate, so-called plagiarism checks should be carried out on the deciding document in question. The final document for the European risk assessment is the EFSA Conclusion of 2015. Moreover, the term ‘plagiarism’ is not relevant in this context.”
In Europe, it was customary and recognized in evaluation procedures for plant protection products that, following critical evaluation, assessment authorities would also integrate relevant passages of documents submitted by applicants into their assessment reports as long as these were up to standard. For the overall assessment of the scientific work of the authorities, quantitative percentages of the share of the official work are not relevant. Decisive is the quality of the critical review by the authorities of the applicant’s dossier and scientific literature. The BfR did not in any way adopt the applicant’s conclusions without first assessing their validity. In accordance with its statutory mandate, the BfR reviews the originals of all reported studies. Critical remarks from the BfR are contained within the RAR. The sole criterion for the consideration of study results is the scientific quality and evidence of the studies themselves. Possible interests of the applicants, politics or other interest groups cannot and must not play any role in a scientific assessment. The BfR rejects all accusations of deliberate deception.
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The BfR is currently in possession of a report with the title Detailed Expert Report on Plagiarism and superordinated Copy Paste in the RAR on Glyphosate. The RAR is an in-house draft in administrative proceedings which has been subjected to several peer reviews and public consultation. The same applies throughout the EU to all procedures for the approval of the active substances contained in plant protection products. The final document used for the European risk assessment is the EFSA Conclusion of 2015.
The report is based principally on Chapter B6 of Volume 3 of the RAR.
Among other details in Volume 3, the BfR gives details of the applicant’s descriptions and assessments of the studies. The BfR’s critique and comments are added in cursive. Thus, it can easily be seen whether the BfR and applicant agreed or not on the findings of each individual study. This procedure, as adopted by the BfR was made public and explained in the introduction to Chapter B6. Independent assessments concerning study relevance, scientific quality and validity were made by the BfR for all of these studies and publications in compliance with legal requirements.
The BfR´s independent health assessment of all of the studies submitted by the applicants and the researched literature is to be found in Volume 1 and not in Volume 3, which was the focus of the new report. This report concludes here that the BfR independently formulated approximately 90% of the decisive chapter in the glyphosate draft. Due to the peculiarities of the procedure, the BfR made a supplementary and independent re-assessment of the genotoxicity and carcinogenicity of the active substance glyphosate (Addendum 1) on behalf of the EU Commission. This addendum was the decisive basis of the EFSA Conclusion in 2015 and subsequent decision of the EU Commission in favour of re-approval.
In order to avoid misunderstandings in the perception of the general public, the BfR, as a leading scientific institution among the assessment authorities, proposed the optimisation of the presentation of the work of the authorities. The current procedural method was therefore changed in order to further increase the transparency of reporting. The fundamental modus operandi of the BfR, i.e. critical review of all of the original data and studies, remains unaffected by this. It constitutes an optimisation of the presentation for the interest of the general public. This new procedure is mandatory for the BfR.
After making their own assessments by means of established, internationally recognised, standard toxicological procedures, the following assessment authorities in Europe and throughout the world concluded that according to the latest available knowledge, glyphosate is not carcinogenic and genotoxic with regard to its effects on humans:
- – The European Food Safety Authority (EFSA) and experts of the risk assessment authorities of the EU member states
– The American Environmental Protection Agency (US-EPA)
– The Canadian Pest Management Regulatory Agency (PMRA)
– The Australian Pesticides and Veterinary Medicines Authority (APVMA)
– The Japanese Food Safety Commission
– New Zealand’s EPA environmental authority
– The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and
– The European Chemicals Agency (ECHA)
The absolute impartiality and independence of the BfR have been established by legal statue. The BfR was founded on 1 November 2002 in order to make independent, scientific, non-partisan risk estimations and strengthen consumer health protection.
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Study:
Weber, S., Burtscher-Schaden, H., 2019, Detailed Expert Report on Plagiarism and superordinated Copy Paste in the Renewal Assessment Report (RAR) on Glyphosate
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.
This text version is a translation of the original German text which is the only legally binding version.
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