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44. BVL, Germany. 2010. Glyphosate – Comments from Germany on the paper by Paganelli, A. et al. (2010): “Glyphosate-based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling”. October 19. http://www.powerbase.info/ index.php/File:BVL2010.comments.Paganelli.pdf
45. BVL, Germany. 2010. Glyphosate – Comments from Germany on the paper by Paganelli, A. et al. (2010): “Glyphosate-based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling”. October 19: 2. http://www.powerbase. info/index.php/File:BVL2010.comments.Paganelli.pdf
46. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 12. http://www.egeis. org/home/glyph_info/list1_glyphosate_en.pdf
47. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607–608.
48. Carrasco, A. E. 2011. Reply to the letter to the editor regarding our article (Paganelli et al., 2010). Chem Res Toxicol 24(5): 610–613.
49. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607.
50. European Commission. 1998. Glyphosate. Reasoned statement of the overall conclusions drawn by the rapporteur member state. In: Glyphosate DAR, released by German government agency BVL on CD, Volume1_Glyphosat_02.pdf: p. 9 of the pdf.
51. European Commission. 1998. Glyphosate. Reasoned statement of the overall conclusions drawn by the rapporteur member state. In: Glyphosate DAR, released by German government agency BVL on CD, Volume1_Glyphosat_02.pdf: p. 9 of the pdf.
52. Paumgartten, F. J. 2010. Influence of maternal toxicity on the outcome of developmental toxicity studies. J Toxicol Environ Health A 73(13-14): 944-951.
53. Beyer, B. K. et al. 2011. ILSI/HESI maternal toxicity workshop summary: Maternal toxicity and its impact on study design and data interpretation. Birth Defects Research Part B: Developmental and Reproductive Toxicology 92: 36–51. February. http:// onlinelibrary.wiley.com/doi/10.1002/bdrb.20281/abstract#fn1
54. There is pressure on regulators from industry and the animal rights movement to reduce animal testing in general and to reduce the number of animals. However, if society wishes to use toxics
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in food production, animal toxicological testing appears to be indispensable for the foreseeable future. And if animals are to
be used in toxicological testing, it is vital that their lives are not wasted – in other words, that the results are as reliable as possible.
55. This is one of the major failures of existing risk assessment:
it does not test the toxicity of real-life human exposures. Epidemiological studies do, but they are often dismissed by regulators because they can only show an association between exposure to a chemical and an effect, not a definite cause and effect relationship – so there is always the possibility that an agent other than the suspect chemical was the culprit.
56. Dallegrave, E., Mantese, F. D. et al. 2007. Pre- and postnatal toxicity of the commercial glyphosate formulation in Wistar rats. Arch Toxicol 81: 665–673.
57. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
58. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
59. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 25 of the pdf.
60. Myers, P., Hessler, W. 2007. Does the dose make the poison? Extensive results challenge a core assumption in toxicology. OurStolenFuture.org, May 25.
61. Welshons, W. V., Thayer, K. A. et al. 2003. Large effects from small exposures. I. Mechanisms for endocrine-disrupting chemicals with estrogenic activity. Environ Health Perspect 111(8): 994-1006.
62. Wetherill, Y. B., Petre, C. E. et al. 2002. The xenoestrogen bisphenol A induces inappropriate androgen receptor activation and mitogenesis in prostatic adenocarcinoma cells. Mol Cancer Ther 1(7): 515-524.
63. Gierthy, J. F. 2002. Testing for endocrine disruption: how much is enough? Toxicol Sci 68(1): 1-3.
64. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
65. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
66. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 18 of the pdf.
67. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 25 of the pdf.
68. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
69. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 19 of the pdf.
70. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for
Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
71. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
72. Maltoni, C., Soffritti, M. et al. 1999. The scientific and methodological bases of experimental studies for detecting and quantifying carcinogenic risks. Ann N Y Acad Sci 895: 10-26.
73. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
74. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 19 of the pdf.
75. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 10 of the pdf.
76. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
77. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
78. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
79. Krieger, R. I. (ed.). 2001. Handbook of Pesticide Toxicology: Principles. Elsevier Inc.: 1185.
80. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf. Emphasis ours.
81. EU Commission. 1999. ECCO Peer Review Meetings: Full Report on Glyphosate. Appendix 1: ECCO 78 reporting table 4, Mammalian toxicity. March 8. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_03. pdf: p. 30 of the pdf.
82. Yoshimura, I., Matsumoto, K. 1994. Notes on the use of historical controls. Environ Health Perspect 102 Suppl 1: 19-23.
83. Cuffe, R. L. 2011. The inclusion of historical control data may reduce the power of a confirmatory study. Stat Med. March 22.
84. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 12. http://www.egeis. org/home/glyph_info/list1_glyphosate_en.pdf
85. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 41 of the pdf.
86. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
87. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 13. http://www.egeis. org/home/glyph_info/list1_glyphosate_en.pdf
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88. While this may be common practice in setting ADIs, we would argue that it is without scientific justification and is grounds for reviewing glyphosate on a more scientifically rigorous basis.
89. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
90. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf. Note: Germany identifies this Monsanto-sponsored study by Lankas with the words, “highest dose”, suggesting that it is the study it used to set the ADI. This is confirmed in its further comment on this study
(see Glyphosate DAR, Volume 3-1_Glyphosate_04.pdf, pp. 28–29 of the pdf). Confusingly, however, Germany goes on to insist that its suggested ADI was not based “on one single study only” but on an assessment of all the long-term studies on rats (see Glyphosate DAR, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf).
91. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
92. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
93. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 44 of the pdf.
94. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
95. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
96. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
97. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
Assault on Science Threatens Your Health. Oxford University Press.
105. Lexchin, J., Bero, L. A. et al. 2003. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. British Medical Journal 326: 1167.
106. Baker, C. B., Johnsrud, M. T. et al. 2003. Quantitative analysis of sponsorship bias in economic studies of antidepressants. British Journal of Psychiatry 183: 498–506.
107. Huss, A., Egger, M. et al. 2007. Source of funding and results of studies of health effects of mobile phone use: Systematic review of experimental studies. Environmental Health Perspectives 115: 1–4.
108. Diels, J., M. Cunha, et al. 2011. Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products. Food Policy 36: 197–203.
109. Bekelman, J. E., Li, Y. et al. 2003. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289(4): 454-465.
110. Swaen, G. M., Meijers, J. M. 1988. Influence of design characteristics on the outcome of retrospective cohort studies. Br J Ind Med 45(9): 624-629.
111. Fagin, D., Lavelle, M. 1999. Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law and Endangers Your Health. Monroe, ME, USA. Common Courage Press.
112. Vom Saal, F. S., Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for
a new risk assessment. Environmental Health Perspectives 113: 926–933.
113. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607.
114. World Health Organisation (WHO). 1994. Glyphosate. Environmental Health Criteria 159. The International Programme on Chemical Safety (IPCS). WHO. Geneva.
115. Carrasco, A. E. 2011. Reply to the letter to the editor regarding our article (Paganelli et al., 2010). Chem Res Toxicol 24(5): 610–613.
116. Williams, G. M., Kroes, R., Munro, I.C. 2000. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans. Regul Toxicol Pharmacol 31(2 Pt 1): 117-165.
117. Cantox. 2011. Our Senior Management Team. http://www. cantox.com/staff.aspx#ian-munro
118. Cantox. 2011. Home page. http://www.cantox.com/
119. Michaels, D. Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health. Oxford University Press, 2008.
120. Layton, L. 2008. Studies on chemical in plastics questioned. Washington Post. April 27, 2008. http://www.washingtonpost. com/wp-dyn/content/article/2008/04/26/AR2008042602126. html?sid=ST2008042602242
121. Dingell, Rep. J. D. (D-Mich.). 2008. Letter to Jack N. Gerard, president and CEO, American Chemistry Council, April 2. http:// www.ewg.org/release/congress-chemical-industry-you-re-under- investigation
122. UNDP/World Bank/World Health Organisation (WHO). 2001. Good Laboratory Practice (GLP). Geneva, Switzerland.
123. Novak, R. A. 2001. The long arm of the lab laws. Today’s Chemist at Work 10(11): 45–46.
124. Novak, R. A. 2001. The long arm of the lab laws. Today’s Chemist at Work 10(11): 45–46.
125. Myers, J. P., Vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315.
126. Novak, R. A. 2001. The long arm of the lab laws. Today’s
98. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
on
99. Romano, R. M., Romano, M. A. et al. 2010. Prepubertal exposure to commercial formulation of the herbicide Glyphosate alters testosterone levels and testicular morphology. Archives of Toxicology 84(4): 309–317.
100. Benedetti, A. L., Vituri, C. d. L. et al. 2004. The effects of sub-chronic exposure of Wistar rats to the herbicide Glyphosate- Biocarb. Toxicol Lett 153(2): 227–232.
101. Huff, J., Jacobson, M. F. et al. 2008. The limits of two-year bioassay exposure regimens for identifying chemical carcinogens. Environ Health Perspect 116(11): 1439–1442.
102. BASF. 2008. Minimise risk – maximise benefits. 15. http://bit. ly/l07Upp
103. BfR. 2011. Regulatory definition of an endocrine disruptor in relation to potential threat to human health. May 16. http://bit.ly/ iFO1hL
104. Michaels, D. 2008. Doubt is Their Product: How Industry’s
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Chemist at Work 10(11): 45–46.
127. Monsanto. 2005. Backgrounder: Testing Fraud: IBT and Craven Labs, Monsanto background paper on Roundup. June.
128. Novak, R. A. 2001. The long arm of the lab laws. Today’s Chemist at Work 10(11): 45–46.
129. OECD Environment Directorate. 1998. OECD Principles on Good Laboratory Practice (as revised in 1997). OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1. ENV/MC/CHEM(98)17. January: 7.
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131. OECD Environment Directorate. 2005. OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substances (Dossier Guidance). Revision 2, May. http:// www.oecd.org/dataoecd/43/26/34870180.pdf
132. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
133. Myers, J. P., Vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315.
134. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
135. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607–608.
136. Myers, J. P., Vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315.
137. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
138. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
139. Sheehan, D. M. 2006. No-threshold dose-response curves for nongenotoxic chemicals: findings and applications for risk assessment. Environ Res 100(1): 93–99.
140. Personal email communication, December 2010.
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147. The non-GLP status of these studies is shown in: Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Volume 2, Part A, Annex A: List of Tests and Studies. In: Glyphosate DAR, released by German government agency BVL on CD.
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153. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092: 16.
154. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092: 16.
155. vom Saal, F. S. and Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
156. vom Saal, F. S. and Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
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157. Myers, J. P., vom Saal, agencies cannot depend on for selecting data: The case Perspectives 117: 309–315
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162. vom Saal, F. S. and C. Hughes. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
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SW: →Impact on Animals and Humans: add info
:* "The EU Commission's expert scientific review panel knew in 1999 that glyphosate causes malformations
:* "The EU Commission has known since 2002 that glyphosate causes malformations."
=== Impact on Non-Target Plants ===
