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Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA)
  1. Christopher J Portier1,
  2. Bruce K Armstrong2,
  3. Bruce C Baguley3,
  4. Xaver Baur4,
  5. Igor Belyaev5,
  6. Robert Bellé6,
  7. Fiorella Belpoggi7,
  8. Annibale Biggeri8,
  9. Maarten C Bosland9,
  10. Paolo Bruzzi10,
  11. Lygia Therese Budnik11,
  12. Merete D Bugge12,
  13. Kathleen Burns13,
  14. Gloria M Calaf14,
  15. David O Carpenter15,
  16. Hillary M Carpenter16,
  17. Lizbeth López-Carrillo17,
  18. Richard Clapp18,
  19. Pierluigi Cocco19,
  20. Dario Consonni20,
  21. Pietro Comba21,
  22. Elena Craft22,
  23. Mohamed Aqiel Dalvie23,
  24. Devra Davis24,
  25. Paul A Demers25,
  26. Anneclaire J De Roos26,
  27. Jamie DeWitt27,
  28. Francesco Forastiere28,
  29. Jonathan H Freedman29,
  30. Lin Fritschi30,
  31. Caroline Gaus31,
  32. Julia M Gohlke32,
  33. Marcel Goldberg33,
  34. Eberhard Greiser34,
  35. Johnni Hansen35,
  36. Lennart Hardell36,
  37. Michael Hauptmann37,
  38. Wei Huang38,
  39. James Huff39,
  40. Margaret O James40,
  41. C W Jameson41,
  42. Andreas Kortenkamp42,
  43. Annette Kopp-Schneider43,
  44. Hans Kromhout44,
  45. Marcelo L Larramendy45,
  46. Philip J Landrigan46,
  47. Lawrence H Lash47,
  48. Dariusz Leszczynski48,
  49. Charles F Lynch49,
  50. Corrado Magnani50,
  51. Daniele Mandrioli51,
  52. Francis L Martin52,
  53. Enzo Merler53,
  54. Paola Michelozzi54,
  55. Lucia Miligi55,
  56. Anthony B Miller56,
  57. Dario Mirabelli57,
  58. Franklin E Mirer58,
  59. Saloshni Naidoo59,
  60. Melissa J Perry60,
  61. Maria Grazia Petronio61,
  62. Roberta Pirastu62,
  63. Ralph J Portier63,
  64. Kenneth S Ramos64,
  65. Larry W Robertson65,
  66. Theresa Rodriguez66,
  67. Martin Röösli67,
  68. Matt K Ross68,
  69. Deodutta Roy69,
  70. Ivan Rusyn70,
  71. Paulo Saldiva71,
  72. Jennifer Sass72,
  73. Kai Savolainen73,
  74. Paul T J Scheepers74,
  75. Consolato Sergi75,
  76. Ellen K Silbergeld76,
  77. Martyn T Smith77,
  78. Bernard W Stewart78,
  79. Patrice Sutton79,
  80. Fabio Tateo80,
  81. Benedetto Terracini81,
  82. Heinz W Thielmann82,
  83. David B Thomas83,
  84. Harri Vainio84,
  85. John E Vena85,
  86. Paolo Vineis86,
  87. Elisabete Weiderpass87,
  88. Dennis D Weisenburger88,
  89. Tracey J Woodruff89,
  90. Takashi Yorifuji90,
  91. Il Je Yu91,
  92. Paola Zambon92,
  93. Hajo Zeeb93,
  94. Shu-Feng Zhou94
  1. 1Environmental Health Consultant, Thun, Switzerland
  2. 2The University of Sydney, Sydney, New South Wales, Australia
  3. 3The University of Auckland, Auckland, New Zealand
  4. 4Charité University Medicine Berlin, Berlin, Germany
  5. 5Cancer Research Institute, Bratislava, Slovak Republic
  6. 6Sorbonne Universités, UPMC Univ Paris 06, UMR8227, Roscoff, France
  7. 7CesareMaltoni Cancer Research Center, Bentivoglio (Bologna), Italy
  8. 8Institute for Cancer Prevention and Research, University of Florence, Italy
  9. 9University of Illinois at Chicago, Chicago, Illinois, USA
  10. 10National Cancer Research Institute, San Martino—IST Hospital, Genoa, Italy
  11. 11University of Hamburg, Hamburg, Germany
  12. 12STAMI, National Institute of Occupational Health, Oslo, Norway
  13. 13Sciencecorps, Lexington, Massachusetts, USA
  14. 14Instituto de Alta Investigación, Universidad de Tarapacá, Arica, Chile
  15. 15Institute for Health and the Environment, University at Albany, Rensselaer, New York, USA
  16. 16Toxicologist, Maplewood, Minnesota, USA
  17. 17National Institute of Public Health, Cuernavaca, Morelos, Mexico
  18. 18Boston University School of Public Health, Boston, Massachusetts, USA
  19. 19Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy
  20. 20Department of Preventive Medicine, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
  21. 21Department of Environment and Primary Prevention, IstitutoSuperiore di Sanità, Rome, Italy
  22. 22Environmental Defense Fund, Austin, Texas, USA
  23. 23Center for Environmental and Occupational Health, University of Cape Town, Cape Town, South Africa
  24. 24Environmental Health Trust, Jackson Hole, Wyoming, USA and The Hebrew University Hadassah School of Medicine, Jerusalem, Israel.
  25. 25Dalla Lana School of Public Health, University of Toronto, Canada
  26. 26Department of Environmental and Occupational Health, Drexel University, Philadelphia, Pennsylvania, USA
  27. 27Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA
  28. 28Department of Epidemiology, Lazio Regional Health Service, Rome, Italy
  29. 29University of Louisville School of Medicine, Louisville, Kentucky, USA
  30. 30School of Public Health, Curtin University, Perth, Western Australia, Australia
  31. 31Department of Environmental Toxicology, The University of Queensland, Brisbane, Australia
  32. 32Department of Population Health Sciences, Virginia Tech, Blacksburg, Virginia, USA
  33. 33Paris Descartes University, France
  34. 34Epi.Consult GmbH, Musweiler, Germany
  35. 35Danish Cancer Society Research Center, Copenhagen, Denmark
  36. 36University Hospital, Orebra, Sweden
  37. 37Biostatistics Branch, Netherlands Cancer Institute, Amsterdam, The Netherlands
  38. 38Faculty of Department of Occupational and Environmental Health, Peking Univ School of Public Health, Beijing, China
  39. 39National Institute for Environmental Health Sciences, Research Triangle Park, North Carolina, USA
  40. 40University of Florida, Gainesville, Florida, USA
  41. 41CWJ Consulting, LLC, Cape Coral, Florida, USA
  42. 42Institute of Environment, Health and Societies, Brunel University London, London, UK
  43. 43Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany
  44. 44Institute for Risk Assessment Sciences, Utrecht University, Utrecht, The Netherlands
  45. 45National Council of Scientific and Technological Research, National University of La Plata, Argentina
  46. 46Arnhold Institute for Global Health, Icahn School of Medicine at Mount Sinai, New York, USA
  47. 47Department of Pharmacology, Wayne State University School of Medicine, Detroit, Michigan, USA
  48. 48Department of Biosciences, University of Helsinki, Helsinki, Finland
  49. 49Department of Epidemiology, University of Iowa, Iowa City, Iowa, USA
  50. 50Cancer Epidemiology Unit, University of Eastern Piedmont, Novara, Italy
  51. 51Cesare Maltoni Cancer Research Center, Bentivoglio (Bologna), Italy
  52. 52Centre for Biophotonics, Lancaster University, UK
  53. 53Department of Prevention, Occupational Health Unit, National Health Service, Padua, Italy
  54. 54Department of Epidemiology Lazio Region, Rome, Italy
  55. 55Occupational and Environmental Epidemiology Unit, ISPO-Cancer Prevention and Research Institute, Florence, Italy
  56. 56Dalla Lana School of Public Health, University of Toronto, Canada
  57. 57Unit of Cancer Epidemiology, University of Turin and CPO-Piemonte, Torino, Italy
  58. 58Department of Environmental and Occupational Health Sciences, City University of New York School of Public Health, USA
  59. 59School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa
  60. 60Department of Environmental and Occupational Health, Milken Institute School of Public Health, The George Washington University, Washington DC, USA
  61. 61Health and Environment-Department of Prevention, Local Health Authority-Empoli, Florence, Italy
  62. 62Department of Biology and Biotechnology “Charles Darwin”, Sapienza Rome University, Italy
  63. 63Department of Environmental Sciences, School of the Coast & Environment, Louisiana State University, Baton Rouge, Los Angeles, USA
  64. 64Center for Applied Genetics and Genomic Medicine, University of Arizona Health Sciences, Tucson, Arizona, USA
  65. 65Iowa Superfund Research Program and the Interdisciplinary Graduate Program in Human Toxicology, University of Iowa, Iowa City, Iowa, USA
  66. 66Center for Research in Health, Work and Environment (CISTA), National Autonomous University of Nicaragua (UNAN-León), León, Nicaragua
  67. 67Swiss Tropical and Public Health Institute, Associated Institute of the University of Basel, Basel, Switzerland
  68. 68College of Veterinary Medicine, Mississippi State University, Mississippi State, USA
  69. 69Department of Environmental and Occupational Health, Florida International University, Miami, Florida, USA
  70. 70Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, Texas, USA
  71. 71Faculty of Medicine, University of São Paulo, São Paulo, Brazil
  72. 72Natural Resources Defense Council and George Washington University, Washington DC, USA
  73. 73Nanosafety Research Centre, Finnish Institute of Occupational Health, Helsinki, Finland
  74. 74Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
  75. 75Department of Pathology, University of Alberta, Edmonton, Alberta, Canada
  76. 76Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
  77. 77School of Public Health, University of California, Berkeley, California, USA
  78. 78Faculty of Medicine, University of New South Wales, Randwick, New South Wales Australia
  79. 79Program on Reproductive Health and the Environment, University of California, San Francisco, California, USA
  80. 80Istituto di Geosceinze e Georisorse (CNR), Padova, Italy
  81. 81University of Torino, Torino, Italy
  82. 82German Cancer Research Center, Heidelberg and Faculty of Pharmacy, Heidelberg University, Germany
  83. 83Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, USA
  84. 84Faculty of Public Health, Kuwait University, Kuwait City, Kuwait
  85. 85Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA
  86. 86Department of Environmental Epidemiology, Imperial College London, London, UK
  87. 87Department of Research, Cancer Registry of Norway, Institute of Population-Based Cancer Research, Oslo, Norway; Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, Tromsø, Norway; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; and Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland.
  88. 88Department of Pathology, City of Hope Medical Center, Duarte, California, USA
  89. 89Program on Reproductive Health and the Environment, University of California, San Francisco, USA
  90. 90Okayama University, Okayama, Japan
  91. 91Institute of Nanoproduct Safety Research, Hoseo University, Asan, The Republic of Korea
  92. 92University of Padua, Padova, Italy
  93. 93Department of Prevention and Evaluation, Leibniz-Institute for Prevention Research and Epidemiology, Bremen, Germany
  94. 94College of Pharmacy, University of South Florida, Tampa, Florida, USA
  1. Correspondence to Dr Christopher J Portier, Environmental Health Consultant, Thun, CH-3600, Switzerland; cportier{at}me.com

https://doi.org/10.1136/jech-2015-207005

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    The International Agency for Research on Cancer (IARC) Monographs Programme identifies chemicals, drugs, mixtures, occupational exposures, lifestyles and personal habits, and physical and biological agents that cause cancer in humans and has evaluated about 1000 agents since 1971. Monographs are written by ad hoc Working Groups (WGs) of international scientific experts over a period of about 12 months ending in an eight-day meeting. The WG evaluates all of the publicly available scientific information on each substance and, through a transparent and rigorous process,1 decides on the degree to which the scientific evidence supports that substance's potential to cause or not cause cancer in humans.

    For Monograph 112,2 17 expert scientists evaluated the carcinogenic hazard for four insecticides and the herbicide glyphosate.3 The WG concluded that the data for glyphosate meet the criteria for classification as a probable human carcinogen.

    The European Food Safety Authority (EFSA) is the primary agency of the European Union for risk assessments regarding food safety. In October 2015, EFSA reported4 on their evaluation of the Renewal Assessment Report5 (RAR) for glyphosate that was prepared by the Rapporteur Member State, the German Federal Institute for Risk Assessment (BfR). EFSA concluded that ‘glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential’. Addendum 1 (the BfR Addendum) of the RAR5 discusses the scientific rationale for differing from the IARC WG conclusion.

    Serious flaws in the scientific evaluation in the RAR incorrectly characterise the potential for a carcinogenic hazard from exposure to glyphosate. Since the RAR is the basis for the European Food Safety Agency (EFSA) conclusion,4 it is critical that these shortcomings are corrected.

    The human evidence

    EFSA concluded ‘that there is very limited evidence for an association between glyphosate-based formulations …

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