Schaden, Helmut Burtscher, Clausing, Peter, & Van Scharen, Hans. “Factsheet: Dangerous Confidence in ‘Good Laboratory Practices,'” February 11, 2020, Corporate Europe Observatory and PAN Germany.

SUMMARY:

Our authorisation system for chemicals is based on the principle that manufacturers must prove, by means of scientifc studies, that their products do not pose unacceptable risks to public health and the environment. It is therefore also the responsibility of manufacturers to commission certifed contract laboratories to carry out the toxicological studies necessary for the approval procedure. As a guarantee against manipulation and falsifcation of these “regulatory” studies, regulatory authorities worldwide rely on the certifed standard of “Good Laboratory Practice” (GLP). This standard provides for strict documentation requirements and regular internal and external controls. However, the current fraud scandal involving a German contract laboratory certifed according to GLP, shows that this trust is unlikely to be justifed. According to reports, GLP studies have been manipulated and falsifed there since 2005.

  • Recent research now shows that LPT has also produced studies that were part of the study package for the EU-wide approval of glyphosate in December 2017: One in seven studies in this package, which was the basis to grant re-approval for glyphosate, came from LPT. These fndings are worrying in two ways: – On the one hand, there is the fundamental question of whether the risk assessments for medicines, pesticides and chemicals based on LPT studies can be trusted.
  •  Even more worrying is the general realisation that laboratories, despite the supposedly “tamper-proof” GLP standard, are apparently able to falsify studies over years and decades without being noticed by the control authorities.

The classifcation of glyphosate as “non-carcinogenic” and “not genotoxic“o is based, among other things, on the European authorities’ full confdence in the GLP system. In the EU assessment proces GLP studies were automatically classifed as reliable; This in stark contrast with the numerous “non-GLP studies” from university research, peer reviewed and published, most of which reported evidence of a genotoxic effect and an increased risk of lymphatic cancer in users of glyphosate, were disqualifed by the authorities as “unreliable“.

The LPT counterfeiting scandal reveals the failure of a regulatory system, that places the commissioning and preparation of studies in the hands of industry. At the same time, it confrms the urgency of a fundamental reform of this system for identifying the risks of chemicals, as called for by the European coalition “Citizens for Science in Pesticide Regulation” in October 2018. FULL TEXT