1. Roundup and birth defects: How the public is being kept in the dark Claire Robinson Earth Open Source www.earthopensource.orgwww.earthopensource.org December 2014

2. Background to our report In 2010 a study was published by Prof Andres Carrasco, which found that glyphosate, the active ingredient in Roundup herbicide, caused malformations (birth defects) in chicken and frog embryos Other studies by independent scientists also showed that Roundup caused malformations in newborn rats

3. This led us to ask… If studies by independent scientists showed a link between malformations and glyphosate/Roundup: What about the original industry studies on which the approval of glyphosate was based? Did they find the same thing?

4. What we did next We obtained the draft assessment report (DAR) on glyphosate from the German government We read those parts of the toxicology section which deal with teratogenicity (birth defects)

5. What we found Even the industry studies conducted in the 1980s and 1990s found that glyphosate causes birth defects, at lower and mid doses as well as high doses

6. Teratogenic effects dismissed by German government German government regulators dismissed these findings on grounds of Nonlinear dose-response (though endocrine effects are often nonlinear) 1 Comparisons with irrelevant “historical control data” Malformation redefined as “developmental variation”

7. “Safe” level of glyphosate may not be safe at all The “acceptable daily intake” (ADI) for glyphosate currently set in Europe is 0.3 mg/kg bw/d Based on the findings of these industry studies, we concluded it should have been set 3 times lower, at 0.1 mg/kg bw/d

8. According to independent studies, ADI should be even lower Based on two independent studies on rats, the ADI should be 12 times lower than the ADI currently in force – 0.025 mg/kg bw/d

9. Peer-reviewed version of our report published

10. We concluded: The current ADI for glyphosate was potentially unsafe New and transparent risk assessment must be conducted Must consider all independent literature

11. Independent studies must be considered by law According to 2009 pesticide regulation, independent studies from the peer- reviewed open literature MUST now be taken into consideration in risk assessment of pesticides That includes setting the ADI.

12. Independent studies ignored European Food Safety Authority (EFSA) issued guideline which allows independent studies to be dismissed as not relevant to the risk assessment, based on “Klimisch criteria”, devised by 3 employees of BASF. Klimisch defines only studies conducted according to OECD and Good Laboratory Practice (GLP) protocols as “reliable” for use in risk assessment Only industry studies are OECD/GLP!

13. “Regulatory toxicology” isolated from real science Industry studies are kept secret We can only see Germany’s summary/comments on the industry studies No independent re-analysis of industry data can be carried out

14. Regulatory toxicology = “virtual reality” Uses methodologies not accepted in mainstream science or out of date: – Compares treatment groups of animals with unpublished and invalid “historical control data” from experiments with different conditions – Assumes that toxic effects must always be linear to the dose – Tests unrealistically high doses (which humans would never be exposed to), enabling toxic effects to be dismissed as irrelevant “poisoning”

15. Industry studies you are not allowed to see Public and independent scientists not allowed to see the industry toxicology studies on glyphosate, BUT Scientists funded by the pesticide industry to rebut our report and other doubts about glyphosate safety were allowed full access.

17. Germany’s renewal assessment report for 2015 re-approval Dismisses independent studies as not relevant, based on Klimisch criteria One reason independent studies judged “irrelevant” is that they test complete formulations as sold and used, whereas industry only tests isolated “active principle”, glyphosate (virtual reality again) Germany proposes to raise the ADI to 0.5 mg/kg bw/!

18. Recommendations 1 I believe that pesticide regulatory approvals would not survive the cold light of day (open scrutiny) We need to force disclosure of secret industry toxicology studies for independent scientific review.

19. Recommendations 2 Complete herbicide formulations like Roundup never tested in animals for long-term safety Research shows Roundup is an endocrine disruptor. Such effects occur at very low doses far below the doses of glyphosate tested in industry studies Long-term animal feeding studies must be carried out using low, realistic doses – at the ADI and below – of the complete formulation, Roundup.

20. Thank you for listening earthopensource.org