Glyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies

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1 Glyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies David A. Eastmond Environmental Toxicology Graduate Program University of California, Riverside

2 Glyphosate Introduction! The most widely used pesticide in the world 826 million kg in 2014! It can be used as an acid or as various salts, in a range of formulation products. It is present in ~750 products in the United States and has been registered for use since 1974.! It targets a enzymatic pathway specific to plants and some bacteria and has historically been considered extremely safe.! It has been caught up in the controversy over genetically modified crops as a common genetic modification is to make the crops resistant to glyphosate. This allows glyphosate to be used to kill many types of weeds without affecting the crop.

3 Glyphosate Introduction (cont.)! In 2015, WHO s International Agency for Research on Cancer conducted a hazard assessment for glyphosate and concluded that it was a probable human carcinogen (Group 2A). Its conclusion was based on limited evidence of cancer in humans (NHL), sufficient evidence in animals, and evidence of genotoxicity and oxidative stress.

4 Photo credit: Global Justice Now

5 Glyphosate Introduction (cont.)! In May 2016, the WHO s Joint Meeting on Pesticide Residues performed a risk assessment on glyphosate and concluded that through the dietary route of exposure, the genotoxic and carcinogenic risks of glyphosate were minimal.! The goal of this presentation is to explain why these two groups could result in seemingly different conclusions.

6 Glyphosate structure Glycine

7 Definitions! Hazard Identification - A determination of the ability of a agent to cause an adverse effect.! Risk Assessment - A characterization of the likelihood or probability that a risk will occur under specific exposure conditions.

8 A Key Aspect of the JMPR Risk Assessment Determine whether glyphosate residues present in the diet pose a genotoxic and/or carcinogenic risk

9 Key Acceptability & Weighting Considerations for Genotoxicity Data! JMPR accepted both published and unpublished (primarily guideline) studies. [IARC only accepted publicly available and published studies.]! JMPR considerations for study weighting - More weight given to higher quality studies & those in validated or well established models - More weight given to in vivo studies than in vitro studies - More weight given to studies in phylogenetically close species (mammals) than in distant species (earthworms, Drosophila, frogs, fish, caiman, etc.)

10 Key Acceptability & Weighting Considerations! JMPR weighting considerations (continued) - More weight given to endpoints considered to be more serious (mutation, chromosome alterations) than to less serious and transient endpoints (DNA strand breaks, SCEs, etc.) - More weight given to studies conducted by more relevant, physiological routes of exposure (e.g. oral) than by non-physiological routes (e.g. intraperitoneal injection).

11 Summary of Genotoxicity Studies Evaluated JMPR IARC Primary Studies Evaluated Human biomonitoring 6 5 In vivo mammals In vitro mammalian cells Bacteria 40 6 Phylogenetically distant in vivo Phylogenetically distant in vitro 12 1 Metabolites in vivo (mammals) 5 1 Metabolites in vitro 16 3

12 Summary of Genotoxicity Studies Evaluated JMPR % Positive IARC Primary Studies Evaluated % Positive Human biomonitoring In vivo mammals In vitro mammalian cells Bacteria Phylogenetically distant in vivo Phylogenetically distant in vitro Metabolites in vivo (mammals) Metabolites in vitro

13 Bacterial Studies JMPR # Positive IARC # Positive Total Bacterial Studies Non standard, coexposures, etc Standard - Ames test or rec test Conclusion: Glyphosate is non-mutagenic and non-genotoxic in standard bacterial mutagenicity tests

14 In Vivo Studies in Mammals JMPR # Positive IARC # Positive Total Mammalian Studies Intraperitoneal administration Oral administration Conclusion: Glyphosate is inactive in vivo in standard mammalian genotoxicity tests when administered by the oral route

15 Human Biomonitoring Studies! Key Study by Bolognesi et al. (2009): Frequency of micronuclei in blood lymphocytes was measured in 3 communities in Columbia before, several days after, and 4 months after glyphosate spraying occurred.! Significant increases in MN were reported in the samples collected shortly after spraying as compared with the pre-spraying samples. - MN frequency issues reference/control frequencies were unusually low and frequencies among the exposed fell at the middle of the normal range. - Methodological concerns repeated measures? - Increases did not correlate with application rates

16 Human Biomonitoring Studies (cont.) - Those reporting exposure did not differ from those reporting no exposure - Authors stated that damage was small and transient, not possible to assign causality to the increases, of low biological relevance, and suggested exposure to other genotoxic agents. - JMPR considered these results to be equivocal whereas IARC considered them to be highly significant.

17 JMPR Genotoxicity Summary Studies Evaluated Human biomonitoring In vivo mammals In vitro mammalian cells Bacteria Phylogenetically distant in vivo Phylogenetically distant in vitro Result Equivocal Mixed, largely negative Mixed, many positive Negative Mixed, largely positive Mixed, largely positive

18 After Applying Weighting Criteria Studies Evaluated Result Quality Human biomonitoring Equivocal Medium In vivo mammals (oral route) Negative High to medium In vitro mammalian cells Mixed, many positive Medium to poor Bacteria Negative High to medium Phylogenetically distant in vivo Mixed, largely positive Medium to poor Phylogenetically distant in vitro Mixed, largely positive Medium to poor

19 Other Mechanistic Considerations! Negative for structural alerts for chromosomal damage, genotoxicity, mutagenicity and carcinogenicity using Derek computer program (Kier and Kirkland, 2013).! Only positive in 21 of 620 screening assays for biological activity in PubChem database. Positive responses were primarily related to its mechanism of action in plants and bacteria. At the concentrations tested, it had few off target cellular and molecular effects.! There is little evidence that glyphosate significantly affects the immune system, a key characteristic of agents that cause NHL in humans.

20 JMPR Genotoxicity Conclusions JMPR: The overall weight of evidence indicates that administration of glyphosate and its formulation products at doses as high as 2000 mg/kg body weight by the oral route, the route most relevant to human dietary exposure, was not associated with genotoxic effects in an overwhelming majority of studies conducted in mammals, a model considered to be appropriate for assessing genotoxic risks to humans.

21 IARC Genotoxicity Conclusions IARC concluded that There is strong evidence that exposure to glyphosate or glyphosate-based formulations is genotoxic based on studies in humans in vitro and studies in experimental animals. One study in several communities in individuals exposed to glyphosate-based formulations also found chromosomal damage in blood cells; in this study, markers of chromosomal damage (micronucleus formation) were significantly greater after exposure than before exposure in the same individuals.

22 Cancer Epidemiology! JMPR: Overall, there is some evidence of a positive association between glyphosate exposure and risk of NHL from the case control studies and the overall meta-analysis. However, it is notable that the AHS, which is the only cohort study and is large and of high quality, found no evidence of association at any exposure level.! The conclusions by JMPR and IARC were similar.

23 Animal Cancer Bioassays The original studies for 20 chronic rodent bioassays were available to the JMPR. 3 were considered inadequate for further evaluation. Consequently,10 rat studies and 7 mouse studies were reviewed. IARC evaluated 5 rat studies and 2 mouse studies. For most, it did not have access to the original reports but based its conclusions on a re-evaluation of data presented in earlier JMPR and EPA reports. It concluded that glyphosate was carcinogenic largely based on an increase in rare kidney tumors in 1 mouse study and an increase in pancreatic tumors in 2 rat studies.

24 Statistical Considerations Multiple Comparisons! In a single sex and species combination of a standard rodent cancer bioassay, histopathology may be performed on 40 individual tissues.! Assuming that a control and 3 treatment doses were administered and the statistical analyses consisted of a trend test and pair-wise comparisons between the control and each dose for each tissue, a total of 160 separate statistical tests would be performed.! Using a p 0.05, one can estimate that 8 of these would be positive by random chance alone.

25 Sensitivity of the Trend Test Number of Number of Dose (ppm) animals tumors , , Trend test: p = (1-tailed)

26 Biological Significance Considerations! Dose response (trend test)! Significant increase of individual treatments (pairwise comparison)! Historical control frequencies! Magnitude of increase! Consistency/reproducibility! Other information relevance of doses and target site, preneoplastic lesions, decreased latency, etc.! Biological plausibility - Genotoxicity, SAR, structural alerts, PubChem results

27 Rat Chronic Bioassay Results! An increased incidence in tumors was observed in one or, in one case, two of the 10 studies in rats. Increases were seen in: - interstitial cell tumors of the testes (1 study) - pancreatic islet cell adenoma (1 study) - thyroid C-cell tumors (1 study) - skin keratoma (2 studies, males only)! The Group concluded that these findings were incidental, in part, because studies that used appreciably higher doses did not find any excess. For the skin keratomas, for one study there was no dose response relationship; and in the other study, only the test for trend was statistically significant, not the pairwise test at any dose.

28 Mouse Chronic Bioassay Results! Suggestive increases in tumor incidences were observed in some of the mouse studies. Two tumor types of particular note were: - Lymphomas (positive trend in 3 studies; negative trend in 1 (NS); and possible increase in another)! The increased trends were significant (p 0.05) by the trend test but not in pairwise comparisons. In one case, the trend test appeared to be driven by unusually low control incidence. The incidences in the high dose animals were typically well within the normal control range for lymphomas. Control frequencies for this type of tumor show considerable variability.

29 Mouse Chronic Bioassay Results! Suggestive increases in tumor incidences were observed in mouse kidney adenomas, an uncommon tumor in mice. - Kidney adenomas (positive trend in 4 studies)! Again, the increases were significant by the trend test but not in pairwise comparisons. For the adenomas, it was noted that the increases were marginal and the significance was driven by the highest dose, which for most studies was well above the currently recommended limit dose. Follow-up evaluations of two studies by two expert pathology groups previously had concluded that the increases were not glyphosate-related. Note: The tumor increases decreased in magnitude with the rescoring of the slides.

30 JMPR Chronic Bioassay Conclusions! The Meeting concluded that glyphosate is not carcinogenic in rats but could not exclude the possibility that it is carcinogenic in mice at very high doses. The doses administered to the mice were up to 50,000 ppm in the diet (approx mg/kg in males and 8700 mg/kg in females).

31 JMPR Cancer Conclusions In view of the absence of carcinogenic potential in rodents at human-relevant doses and the absence of genotoxicity by the oral route in mammals, and considering the epidemiological evidence from occupational exposures, the Meeting concluded that glyphosate is unlikely to pose a carcinogenic risk to humans from exposure through the diet.

32 JMPR Overall Conclusions! The Meeting reaffirmed the group ADI for the sum of glyphosate, AMPA, N-acetyl-glyphosate and N- acetyl-ampa of 0 1 mg/kg bw on the basis of the NOAEL of 100 mg/kg bw per day for effects on the salivary gland in a long-term study of toxicity and carcinogenicity in rats and application of a safety factor of 100.

33 Overall Conclusions! In summary, the glyphosate toxicology and epidemiology data set is a complex one that required considerable expertise and scientific judgment to evaluate.! Decisions about whether glyphosate is genotoxic or carcinogenic were heavily dependent upon the information available, the evaluation criteria used, and the weights given to various types of evidence.

34 Overall Conclusions! The conclusions reached by IARC are reflective of the data to which it had access, and are generally consistent with its criteria for classifying carcinogens.! The JMPR had access to a larger data set. Its conclusions were also reflective of the data to which it had access, and were consistent with its specific emphasis on dietary exposure to pesticide residues. Its results indicate that the genotoxic and carcinogenic risks from glyphosate residues in the diet are very low.

35 Acknowledgments! JMPR Expert Group - Boobis, Busschers, Cerniglia, Cordier, Eastmond, Hartwig, Jacobs, Lenters, MacLachlan, Moretto, O Mullane, Piersma, Shah, Smith, Tice, Toledano, Yoshida and Zarn Foyer of WHO building in Geneva! JMPR Secretariat - Philippe Verger - Angelika Tritscher

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