Glyphosate Task Force Technical Statement on IARC Monograph
Since the publication of the IARC preliminary classification of glyphosate in The Lancet in March 2015, IARC has taken steps to clarify its scope and purpose. IARC has specified that it “evaluates cancer hazards but not risks associated with exposure.” Unlike regulatory agencies globally, which conduct thorough risk assessments on pesticide active ingredients based on the totality of relevant available data, IARC conducted a limited hazard identification based on a subset of the literature on glyphosate.
© Glyphosate Task Force The GTF reaffirms that it is the role of regulatory agencies around the world to conduct thorough risk assessments and evaluate the safety of pesticide active ingredients. The regulatory risk-assessment approach is built off of sound scientific procedures during which (1) all available relevant information is considered; (2) general principles of toxicology evaluation are honored (e.g. acceptance of historical control data, critical assessment of relevance, reliability, repeatability and experimental design of experiments, etc); and (3) the weight of evidence is valued and considered in the context of toxicology classification.
The ongoing European regulatory evaluation of glyphosate has reviewed all available, relevant information on glyphosate, including the data considered by IARC. As part of this review, regulatory evaluators have explicitly stated that they found no grounds to classify glyphosate for carcinogenicity.
In addition, GTF has conducted a preliminary review of the IARC monograph. This preliminary review has identified multiple shortcomings in IARC’s assessment. Specifically, GTF points out the following shortcomings and flaws in the IARC monograph:
• IARC’s monograph does not present new research data. It does not consider new or original data on hazard, exposure or risk of glyphosate. All the key studies considered by IARC in the monograph have been previously reviewed and considered by regulatory agencies, most recently in the context of a comprehensive toxicology assessment conducted on behalf of the EU’s ongoing regulatory review. No regulatory agency in the world considers glyphosate to be a carcinogen.
• Unlike regulatory agencies, IARC did not consider the total weight of evidence available for glyphosate. It is clear from the limited references listed in the monograph that the information actually selected for consideration by the IARC panel represents only a subset of the vast dataset available on glyphosate. Consideration of the complete dataset, as done by regulators globally, overwhelmingly supports the conclusions of safety and lack of carcinogenic potential of glyphosate.
• IARC selected data points and made very basic errors in data interpretation within each of the four areas of evidence they considered (animal carcinogenicity, exposure, genotox and epidemiology). These errors included reinterpreting or misinterpreting the findings of studies; citing old references and considering an incomplete review of the literature; relying on non-standard studies which used methods that have not been validated and /or not conducted according to international guidelines; and ignoring the findings of the largest and single most important study into the health of pesticide applicators in the United States.
GTF and its member companies will continue to review the IARC monograph in more detail. We encourage regulators to continue to follow thorough and science-based methods of risk assessment in reviewing all crop protection products.
Last update: 18 August 2015