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Review Articles

A review of the carcinogenic potential of glyphosate by four independent expert panels and comparison to the IARC assessment

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Pages 3-20 | Received 08 Apr 2016, Accepted 15 Jul 2016, Published online: 28 Sep 2016

References

  • Acquavella JF, Alexander BH, Mandel JS, Gustin C, Baker B, Chapman P, Bleeke M. 2004. Glyphosate for farmers and their families: results from the Farm Family Exposure Study. Environ Health Perspect. 112:321–326.
  • Acquavella J, Garabrant D, Marsh G, Sorahan T, Weed DL. 2016. Glyphosate epidemiology expert panel review: a weight of evidence systematic review of the relationship between glyphosate exposure and non-Hodgkin?s lymphoma or multiple myeloma. Crit Rev Toxicol, in this issue. doi:10.1080/10408444.2016.1214681.
  • APVMA. 2013. A review of the Earth Open Source (EOS) report “Roundup and birth defects: is the public being kept in the dark?” Prepared by Canberra (Australia): Scitox Assessment Services for Canberra (Australia): Australian Pesticides and Veterinary Medicine Authority (APVMA). Available from: http://archive.apvma.gov.au/news_media/docs/glyphosate_scitox_review_july_2013.pdf.
  • Arysta Life Sciences. 1997. HR-001: 18-month oral oncogenicity study in mice. Tokyo (Japan): The Institute of Environmental Toxicology. Cited In: Greim et al. 2015 [As: Arysta Life Sciences 1997a].
  • Aschengrau A, Seage GR. III. 2003a. Bias. In: Essentials of epidemiology in public health. Sudbury (MA): Jones and Bartlett Publishers; p. 251–279.
  • Aschengrau A, Seage GR. III. 2003b. Guide to the critical review of epidemiologic studies. In: Essentials of epidemiology in public health. Sudbury (MA): Jones and Bartlett Publishers; p. 348–374.
  • Bannasch P, Haertel T, Su Q. 2003. Significance of hepatic preneoplasia in risk identification and early detection of neoplasia. Toxicol Pathol. 31:134–139.
  • Bolognesi C, Carrasquilla G, Volpi S, Solomon KR, Marshall EJP. 2009. Biomonitoring of genotoxic risk in agricultural workers from five Colombian regions: association to occupational exposure to glyphosate. J Toxicol Environ Health. A. 72:986–997. Cited In: IARC 2015.
  • Bolt HM, Foth H, Hengstler JG, Degen GH. 2004. Carcinogenicity categorization of chemicals-new aspects to be considered in a European perspective. Toxicol Lett. 151:29–41.
  • Brown LM, Burmeister GD, Everett GD, Blair A. 1993. Pesticide exposures and multiple myeloma in Iowa men. Cancer Causes Control. 4:153–156. Cited In: IARC 2015.
  • Brusick D, Aardema M, Kier L, Kirkland D, Williams G. 2016. Genotoxicity Expert Panel review. Weight-of-evidence evaluation of the genotoxicity of glyphosate, glyphosate-based formulations and aminomethylphosphonic acid. Crit Rev Toxicol, in this issue. doi:10.1080/10408444.2016.1214680.
  • Cantor KP, Blair A, Everett G, Gibson R, Burmeister LF, Brown LM, Schuman L, Dick FR. 1992. Pesticides and other agricultural risk factors for Non-Hodgkin’s Lymphoma among men in Iowa and Minnesota. Cancer Res. 52:2447–2455.
  • Carmichael N, Bausen M, Boobis AR, Cohen SM, Embry M, Fruijtier-Pölloth C, Greim H, Lewis R, Meek ME, Mellor H, et al. 2011. Using mode of action information to improve regulatory decision-making: an ECETOC/ILSI RF/HESI workshop overview. Crit Rev Toxicol. 41:175–186.
  • Chang FC, Simcik MF, Capel PD. 2011. Occurrence and fate of the herbicide glyphosate and itsdegradateaminomethylphosphonic acid in the atmosphere. Environ Toxicol Chem. 30:548–555.
  • Cheminova. 1993. 104 week combined chronic feeding/oncogenicity study in rats with 52 week interim kill (results after 104 weeks) [Unpublished Report] Tranent (Scotland): Inveresk Research International, Ltd. Submitted to WHO by Lemvig (Denmark): Cheminova A/S (Report No. 7867, IRI project No. 438623). Cited In: Greim et al. 2015 [As: Cheminova 1993a]. Cited In: JMPR 2006 [As: Atkinson et al. 1993b].
  • Chruscielska K, Brzezinski J, Kita K, Kalhorn D, Kita I, Graffstein B, Korzeniowski P. 2000. Glyphosate – evaluation of chronic activity and possible far-reaching effects. Part 1. Studies on chronic toxicity. Pestycydy (Warsaw) (3/4):11–20. Cited In: Greim et al. 2015 [As: Chruscielska et al. 2000a].
  • Cimino MC. 2006. Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes. Environ Mol Mutagen. 47:362–390.
  • Cocco P, Satta G, Dubois S, Pili C, Pilleri M, Zucca M, ‘t Mannetje AM, Becker N, Benavente Y, de Sanjosé S, et al. 2013. Lymphoma risk and occupational exposure to pesticides: results of the Epilymph study. Occup Environ Med. 70:91–98.
  • Curwin BD, Hein MJ, Sanderson WT, Striley C, Heederik D, Kromhout H, Reynolds SJ, Alavanja MC. 2007. Urinary pesticide concentrations among children, mothers and fathers living in farm and non-farm households in Iowa. Ann Occup Hyg. 51:53–65.
  • de Roos AJ, Zahm SH, Cantor KP, Weisenburger DD, Holmes FF, Burmeister LF, Blair A. 2003. Integrative assessment of multiple pesticides as risk factors for non-Hodgkin’s lymphoma among men. Occup Environ Med. 60:E11. doi:10.1136/oem.60.9.e11.
  • de Roos AJ, Blair A, Rusiecki JA, Hoppin JA, Svec M, Dosemeci M, Sandler DP, Alavanja MC. 2005. Cancer incidence among glyphosate-exposed pesticide applicators in the Agricultural Health Study. Environ Health Perspect. 113:49–54. Cited In: IARC 2015 [As de Roos et al. 2005a].
  • Dearfield KL, Thybaud V, Cimino MC, Custer L, Czich A, Harvey JS, Hester S, Kim JH, Kirkland D, Levy DD, et al. 2011. Follow-up actions from positive results of in vitro genetic toxicity testing. Environ Mol Mutagen. 52:177–204.
  • Eastmond DA, Hartwig A, Anderson D, Anwar WA, Cimino MC, Dobrev I, Douglas GR, Nohmi T, Phillips DH, Vickers C. 2009. Mutagenicity testing for chemical risk assessment: update of the WHO/IPCS Harmonized Scheme. Mutagenesis. 24:341–349.
  • ECHA. 2010. European Chemicals Agency. Practical Guide 2: How to Report Weight of Evidence. 24 March. ECHA-10-B-05-EN. Available from: http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf.
  • EFSA. 2011. Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment (EFSA Scientific Committee) (Question no EFSA-Q-2009-00782, adopted on 13 September 2011 by European Food Safety Authority, 3 October 2012, replaces the earlier version). EFSA J. 9:2379 [69 p.]. doi:10.2903/j.efsa.2011.2379. Available from: http://www.efsa.europa.eu/en/efsajournal/pub/2379.htm.
  • EFSA. 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (EFSA-Q-2014-00546, EFSA-Q-2015-00279, approved on 30 October 2015 by European Food Safety Authority). EFSA J. 13:4302. [107 p.]. doi:10.2903/j.efsa.2015.4302. Available from: http://www.efsa.europa.eu/en/efsajournal/pub/4302.
  • Eriksson M, Hardell L, Carlberg M, Akerman M. 2008. Pesticide exposure as risk factor for non-Hodgkin lymphoma including histopathological subgroup analysis. Int J Cancer. 123:1657–1663. Cited In: IARC 2015.
  • European Commission. 2002. Review report for the active substance glyphosate. Finalised in the Standing Committee on Plant Health at its meeting on 29 June 2001 in view of the inclusion of glyphosate in Annex I of Directive 91/414/EEC. Brussels (Belgium): European Commission (EC), Health and Consumer Protection Directorate General (6511/VI/99-Final). Available from: http://ec.europa.eu/food/fs/sfp/ph_ps/pro/eva/existing/list1_glyphosate_en.pdf.
  • Feinchemie Schwebda. 2001. Carcinogenicity study with glyphosate technical in Swiss Albino mice [Unpublished Report]. Bangalore (India): Rallis India, Ltd. Cited In: Greim et al. 2015.
  • Greim H, Saltmiras D, Mostert V, Strupp C. 2015. Evaluation of carcinogenic potential of the herbicide glyphosate, drawing on tumor incidence data from fourteen chronic/carcinogenicity rodent studies. Crit Rev Toxicol. 45:185–208.
  • Guyton KZ, Loomis D, Grosse Y, El Ghissassi F, Benbrahim-Tallaa L, Guha N, Scoccianti C, Mattock H, Straif K. 2015. Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate International Agency for Research on Cancer Monograph Working Group, IARC, Lyon, France. Lancet Oncol. 16:490–491.
  • Hardell L, Eriksson M. 1999. A case-control study of non-Hodgkin lymphoma and exposure to pesticides. Cancer. 85:1353–1360.
  • Hardell L, Eriksson M, Nordström M. 2002. Exposure to pesticides as risk factor for non-Hodgkin’s lymphoma and hairy cell leukemia: pooled analysis of two Swedish case-control studies. Leuk Lymphoma. 43:1043–1049. Cited In: IARC 2015.
  • Haseman JK. 1983. A reexamination of false-positive rates for carcinogenesis studies. Fundam Appl Toxicol. 3:334–339.
  • Health and Welfare Canada. 1991. Preharvest application of glyphosate (Roundup) herbicide. Ottawa (ON): Health and Welfare Canada, Pest Management Regulatory Agency (PMRA), Plant Industry Directorate. Pesticide Information Division (Pesticides Directorate Discussion Document, Vol. 91, Iss. 1, 92 p.
  • Health Canada. 2015. Proposed re-evaluation decision PRVD2015-01, glyphosate. Ottawa (ON): Health Canada, Pest Management Regulatory Agency (PMRA). Available from: http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_prvd2015-01/prvd2015-01-eng.php [Archived June 17, 2015].
  • Hill AB. 1965. The environment and disease: association or causation. J R Soc Med. 58:295–300.
  • Hill AB. 1971. Statistical evidence and inference. In: A short textbook of medical statistics. London: Hodder and Stoughton; p. 283–296.
  • Hohenadel K, Harris SA, McLaughlin JR, Spinelli JJ, Pahwa P, Dosman JA, Demers PA, Blair A. 2011. Exposure to multiple pesticides and risk of non-Hodgkin Lymphoma in men from six Canadian provinces. Int J Environ Res Public Health. 8:2320–2330.
  • Holsapple MP, Pitot HC, Cohen SM, Boobis AR, Klaunig JE, Pastoor T, Dellarco VL, Dragan YP. 2006. Mode of action in relevance of rodent liver tumors to human cancer risk. Toxicol Sci. 89:51–56.
  • Honeycutt Z, Rowlands H. 2014. Glyphosate testing report: findings in American mothers’ breast milk, urine and water. Moms Across America & Sustainable Pulse, 19 p. Available from: https://d3n8a8pro7vhmx.cloudfront.net/yesmaam/pages/774/attachments/original/1396803706/Glyphosate__Final__in_the_breast_milk_of_American_women_Draft6_.pdf?1396803706.
  • Hoppe H-W. 2013. Determination of glyphosate residue in human urine samples from 18 European countries. Bremen (Germany): Medical Laboratory Bremen (Report Glyphosate MLHB-2013-06-06), 18 p. Available from: https://www.bund.net/fileadmin/bundnet/pdfs/gentechnik/130612_gentechnik_bund_glyphosat_urin_analyse.pdf.
  • IARC. 2006. Data for the Monographs. Preamble to the IARC Monographs (amended January 2006). Lyon (France): World Health Organization (WHO), International Agency for Research on Cancer (IARC). Available from: http://monographs.iarc.fr/ENG/Preamble/index.php.
  • IARC. 2015. Glyphosate. In: Some organophosphate insecticides and herbicides: diazinon, glyphosate, malathion, parathion, tetrachlorvinphos. IARC Working Group, March 3–10, 2015, Lyon (France). Lyon (France): World Health Organization (WHO), International Agency for Research on Cancer (IARC) (IARC Monographs on the Evaluation of Carcinogen Risks to Humans, Vol. 112), p. 1–92. Available from: http://monographs.iarc.fr/ENG/Monographs/vol112/index.php.
  • ICH. 1997. Testing for carcinogenicity of pharmaceuticals: S1B. Geneva: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (ICH Harmonised Tripartite Guideline – Current Step 4 version dated 16 July 1997). Available from: http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html [Open S1B].
  • ICH. 2011. Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use: S2(R1). Geneva (Switzerland): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (ICH Harmonised Tripartite Guideline – Current Step 4 version [Combines S2A & S2B]). Available from: http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html.
  • James RC, Britt JK, Halmes NC, Guzelian PS. 2015. Evidence-based causation in toxicology: a 10-year retrospective. Hum Exp Tox. 34:1245–1252.
  • JMPR. 1987. Glyphosate. In: Pesticide residues in food – 1986: part II – toxicology. Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment (JMPR) and the WHO Expert Group on Pesticide Residues, September 29–October 8, 1986, Rome. Rome: Food and Agriculture Organization of the United Nations (FAO)/FAO Panel of Experts on Pesticide Residues in Food and the Environment/WHO Expert Group on Pesticide Residues Joint FAO/WHO Meeting on Pesticide Residues (JMPR) (FAO Plant Production and Protection Paper, Vol. 78), p. 63–76. Available from: http://www.inchem.org/documents/jmpr/jmpmono/v86pr08.htm.
  • JMPR. 2006. Glyphosate. In: Pesticides residues in food – 2004. Evaluations 2004 Part II–Toxicological. Joint Meeting of the FAO Panel of Experts on Pesticide residues in Food and the Environment and the WHO Core Assessment Group (JMPR), Sep 20–29, 2004, Rome. Rome: Food and Agriculture Organization of the United Nations (FAO)/Geneva: World Health Organization (WHO), International Programme on Chemical Safety (IPCS) (WHO/PCS/06.1), p. 95–169. Available from: http://www.inchem.org/documents/jmpr/jmpmono/v2004pr01.pdf.
  • JMPR. 2014. 5.21. Glyphosate (158) and metabolites. In: Pesticide residues in food 2013. Joint FAO/WHO Meeting on Pesticide Residues and the WHO Core Assessment Group on Pesticide Residues, Geneva,17 to 26 September 2013. Rome: Food and Agriculture Organization of the United Nations/Geneva, World Health Organization (WHO) (FAO Plant Production and Protection Paper No. 219), p. 225–228, 484–486. Available from: http://www.fao.org/publications/card/en/c/299ca869-ae51-5093-8407-9cb30782b9f5/.
  • JMPR. 2016. Glyphosate (158). In: Pesticide residues in food 2016. Special Session of the Joint FAO/WHO Meeting on Pesticide Residues, Geneva, 9 to 13 May 2016. Rome: Food and Agriculture Organization of the United Nations/Geneva, World Health Organization (WHO) (FAO Plant Production and Protection Paper No. 227), p. 19–28, 45, 72–82. Available from: http://www.fao.org/3/a-i5693e.pdf.
  • Jönsson J, Camm R, Hall T. 2013. Removal and degradation of glyphosate in water treatment: a review. Aqua. 62:395–408.
  • Kachuri L, Demers PA, Blair A, Spinelli JJ, Pahwa M, McLaughlin JR, Pahwa P, Dosman JA, Harris SA. 2013. Multiple pesticide exposures and the risk of multiple myeloma in Canadian men. Int J Cancer. 133:1846–1858. Cited In: IARC 2015.
  • Kier LD. 2015. Review of genotoxicity biomonitoring studies of glyphosate-based formulations. Crit Rev Toxicol. 45:209–918.
  • Kier LD, Kirkland DJ. 2013. Review of genotoxicity studies of glyphosate and glyphosate-based formulations. Crit Rev Toxicol. 43:283–315.
  • Kirkland D, Reeve L, Gatehouse D, Vanparys P. 2011. A core in vitro genotoxicity battery comprising the Ames test plus the in vitro micronucleus test is sufficient to detect rodent carcinogens and in vivo genotoxins. Mutat Res. 721:27–73.
  • Kirsch-Volders M, Bonassi S, Knasmueller S, Holland N, Bolognesi C, Fenech MF. 2014. Commentary: critical questions, misconceptions and a road map for improving the use of the lymphocyte cytokinesis-block micronucleus assay for in vivo biomonitoring of human exposure to genotoxic chemicals-a HUMN project perspective. Mutat Res Rev Mutat Res. 759:49–58.
  • Klimisch H-J, Andreae M, Tillmann U. 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol. 25:1–5. Cited In: Greim et al. 2015.
  • Krüger M, Schledorn P, Shrödl W, Wolfgang Hoppe H, Lutz W, Shehata AA. 2014. Detection of glyphosate residues in animals and humans. J Environ Anal Toxicol. 4:210. doi: 10.4172/2161-0525.1000210.
  • Landgren O, Kyle RA, Hoppin JA, Freeman LEB, Cerhan JR, Katzmann JA, Rajkumar SV, Alavanja MC. 2009. Pesticide exposure and risk of monoclonal gammopathy of undetermined significance in the Agricultural Health Study. Blood. 113:6386–6391.
  • Markard C. 2014. Ergebnisse der Vorstudie HBM von Glyphosat. Dessau-Roßlau (Germany): Federal Environmental Agency (UBA), Umweltprobenbank des Bundes [Unpublished Report provided to] Berlin (Germany): German Federal Institute for Risk Assessment (BfR).
  • Maronpot RR, Yoshizawa K, Nyska A, Harada T, Flake G, Mueller G, Singh B, Ward JM. 2010. Hepatic enzyme induction: histopathology. Toxicol Pathol. 38:776–795.
  • McDuffie HH, Pahwa P, McLaughlin JR, Spinelli JJ, Fincham S, Dosman JA, Robson D, Skinnider LF, Choi NW. 2001. Non-Hodgkin’s lymphoma and specific pesticide exposures in men: Cross-Canada study of pesticides and health. Cancer Epidemiol Biomarkers Prev. 10:1155–1163. Cited In: IARC 2015.
  • Mesnage R, Moesch C, Grand R, Lauthier G, Vendômois J, Gress S, Séralini G. 2012. Glyphosate exposure in a farmer’s family. J Environ Protect. 3:1001–1003.
  • Moher D, Liberati A, Tetzlaff J, Altman DG. 2009. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. Ann Intern Med. 151:264–269. W264.
  • Monsanto. 1983. A chronic feeding study of glyphosate (Roundup® technical) in mice [Unpublished Report]. East Millstone (NJ): Bio/dynamics Inc. (Project #77-2062, 1981). Cited In: Greim et al. 2015.
  • Niemann L, Sieke C, Pfeil R, Solecki R. 2015. A critical review of glyphosate findings in human urine samples and comparison with the exposure of operators and consumers. J Verbr Lebensm. 10:3–12.
  • Nordstrom M, Hardell L, Magnuson A, Hagberg H, Rask-Andersen A. 1998. Occupational exposures, animal exposure and smoking as risk factors for hairy cell leukaemia evaluated in a case-control study. Br J Cancer. 77:2048–2052.
  • Nufarm. 2009. Glyphosate technical: dietary carcinogenicity study in the mouse [Unpublished Report] Derbyshire (UK): Harlan Laboratories Ltd. Cited In: Greim et al. 2015 [As: Nufarm 2009a].
  • OECD. 2009. Combined chronic toxicity\carcinogenicity studies. In: OECD guidelines for the testing of chemicals. Paris (France): Organisation for Economic Co-operation and Development (OECD) (OECD Guideline No. 453) [Adopted: 7 September 2009]. Available from: http://www.oecd-ilibrary.org/environment/test-no-453-combined-chronic-toxicity-carcinogenicity-studies_9789264071223-en
  • OECD. 2014. Guidance document for describing non-guideline in vitro test methods. Paris, France: Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides, and Biotechnology. Paris (France): Organisation for Economic Co-operation and Development (OECD), Environment Directorate, Health and Safety Publications (Series on Testing and Assessment no 211; ENV/JM/MONO(2014)35). Available from: http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2014)35&doclanguage = en.
  • OECD. 2015. Overview of the set of OECD genetic toxicology test guidelines and updates performed in 2014-2015. Paris (France): Organisation for Economic Co-operation and Development (OECD), Environment Directorate, Health and Safety Publications. Available from: http://www.oecd.org/chemicalsafety/testing/Genetic%20Toxicology%20Guidance%20Document%20Aug%2031%202015.pdf.
  • Orsi L, Delabre L, Monnereau A, Delval P, Berthou C, Fenaux P, Marit G, Soubeyran P, Huguet F, Milpied N, et al. 2009. Occupational exposure to pesticides and lymphoid neoplasms among men: results of a French case-control study. Occup Environ Med. 66:291–298. Cited In: IARC 2015.
  • Pahwa P, Karunanayake CP, Dosman JA, Spinelli JJ, McDuffie HH, McLaughlin JR. 2012. Multiple myeloma and exposure to pesticides: a Canadian case-control study. J Agromedicine. 17:40–50.
  • Paz-y-Miño C, Muñoz MJ, Maldonado A, Valladares C, Cumbal N, Herrera C, Robles P, Sánchez ME, López-Cortés A. 2011. Baseline determination in social, health, and genetic areas in communities affected by glyphosate aerial spraying on the northeastern Ecuadorian border. Rev Environ Health. 26:45–51. Cited In: IARC 2015.
  • Paz-y-Miño C, Sánchez ME, ArévaloI M, Muñoz MJ, Wittel T, Oleas De-la-CarreraI G, Leonel PEII. 2007. Evaluation of DNA damage in an Ecuadorian population exposed to glyphosate. Genet Mol Biol. 30:456–460. Cited In: IARC 2015.
  • Petkov PI, Patlewicz G, Schultz TW, Honma M, Todorov M, Kotov S, Dimitrov SD, Donner EM, Mekenyan OG. 2015. A feasibility study: can information collected to classify for mutagenicity be informative in predicting carcinogenicity? Regul Toxicol Pharmacol. 72:17–25.
  • Pratt IS, Barron T. 2003. Regulatory recognition of indirect genotoxicity mechanisms in the European Union. Toxicol Lett. 140/141:53–62.
  • Sanderson S, Tatt LD, Higgins JPT. 2007. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol. 36:666–676.
  • Solomon K. 2016. Glyphosate in the general population and in applicators: a critical review of studies on exposures. Crit Rev Toxicol, in this issue. doi:10.1080/10408444.2016.1214678.
  • Sorahan T. 2015. Multiple myeloma and glyphosate use: a re-analysis of US agricultural health study (AHS) data. Int J Environ Res Public Health. 12:1548–1559.
  • Speit G. 2013. Does the recommended lymphocyte cytokinesis-block micronucleus assay for human biomonitoring actually detect DNA damage induced by occupational and environmental exposure to genotoxic chemicals? Mutagenesis. 28:375–380.
  • Stout LD, Ruecker FA. 1990. Chronic study of glyphosate administered in feed to Albino rats [Unpublished Report] St Louis (MO): Monsanto Agricultural Company (No. MSL-10495, job/project No. ML-87-148/EHL 87122). Cited In: JMPR 2006.
  • Suter GWII, Cormier SM. 2011. Why and how to combine evidence in environmental assessments: weighing evidence and building cases. Sci Total Environ. 409:1406–1417.
  • US EPA. 1985. Glyphosate; EPA Reg. #: 524-308; mouse oncogenicity study [memo]. Washington (DC): U.S. Environmental Protection Agency (US EPA) (Document No. 004370). Available from: http://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/html/103601.html.
  • US EPA. 1986a. Glyphosate; EPA Reg. #: 524-308; Roundup; additional histopathological evaluations of kidneys in the chronic feeding study of glyphosate in mice [memo]. Washington (DC): U.S. Environmental Protection Agency (US EPA) (Document No. 005590). Available from: http://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/html/103601.html.
  • US EPA. 1986b. Transmittal of the final FIFRA Scientific Advisory Panel reports on the February 11–12, 1986 Meeting. Washington (DC): Environmental Protection Agency (US EPA), Office of Pesticides and Toxic Substances. Available from: http://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/html/103601.html.
  • US EPA. 1986c. Guidelines for carcinogen risk assessment. Washington (DC): U.S. Environmental Protection Agency (US EPA) (EPA/630/P-03/001FMarch 2005). Available from: http://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf.
  • US EPA. 1990. Determination of glyphosate in drinking water by direct-aqueous-injection HPLC, post column derivatization, and fluorescence detection. In: Methods for the determination of organic compound in drinking water – supplement I. Washington (DC): U.S. Environmental Protection Agency (US EPA), Office of Research and Development (EPA/600/4-90/020). Available from: http://nepis.epa.gov/Exe/ZyPDF.cgi/30000UX8.PDF?Dockey =30000UX8.PDF.
  • US EPA. 1991a. Second peer review of glyphosate [memo]. Washington (DC): U.S. Environmental Protection Agency (US EPA). Available from: http://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/html/103601.html.
  • US EPA. 1991b. Glyphosate; 2-year combined chronic toxicity/carcinogenicity study in Sprague-Dawley rats – list a pesticide for reregistration [memo]. Washington (DC): U.S. Environmental Protection Agency (US EPA) (Document No. 008390). Available from: http://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/html/103601.html.
  • US EPA. 1991c. Peer review on glyphosate [Memo]. Washington (DC): U.S. Environmental Protection Agency (US EPA), Office of Pesticides, and Toxic Substances. Cited In: IARC 2015 [As: EPA 1991c].
  • US EPA. 1993. Reregistration Eligibility Decision (RED): glyphosate. Washington (DC): U.S. Environmental Protection Agency (US EPA), Office of Prevention, Pesticides, and Toxic Substances (EPA 738-R-93-014). Available from: http://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC-417300_1-Sep-93.pdf.
  • US EPA. 2005. Guidelines for Carcinogen Risk Assessment [EPA/630/P-03/001F]. Washington (DC): U.S. Environmental Protection Agency (U.S. EPA), Risk Assessment Forum, National Center for Environmental Assessment (NCEA). Available from: http://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
  • US EPA. 2009. Exposure factors handbook: review draft. Washington (DC): U.S. Environmental Protection Agency (US EPA), Office of Research and Development, National Center for Environmental Assessment (No. EPA/600/R-09/052A), 1265 p. Available from: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid =209866 [Archived].
  • US EPA. 2012. Glyphosate. section 3 registration concerning the application of glyphosate to carrots, sweet potato, teff, oilseeds (crop group (CG) 20) and to update the CG definitions for bulb vegetable (CG 3-07), fruiting vegetable (CG 8-10), citrus fruit (CG 10-10), porne fruit (CG 11-10), berry (CG 13-07), human health risk assessment. Washington (DC): U.S. Environmental Protection Agency (US EPA), Office of Chemical Safety and Pollution Prevention (Decision No.: 459870), 28 p.
  • US EPA. 2013. Glyphosate pesticide tolerances; Final rule (40 CFR Part 180) [EPA–HQ–OPP–2012–0132; FRL–9384–3]. Fed Regist (US). 78:25396–25401. Available from: http://www.regulations.gov/#%21documentDetail;D=EPA-HQ-OPP-2012-0132-0009.
  • US FDA. 2001. Draft guidance for industry on the statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals; Availability [Docket No. 01N–0006]. Fed Regist (US). 66:23266–23267.
  • US FDA. 2006. Guidance for industry and review staff: recommended approaches to integration of genetic toxicology study results. Rockville (MD): US Food and Drug Administration (US FDA), Center for Drug Evaluation and Research (CDER). Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079257.pdf.
  • USGS. 2015. NAWQA Database. Reston (VA): United States Geological Survey (USGS). Available from: http://cida.usgs.gov/nawqa_public/apex/f?p=136:1:0, Accessed September 2 2015.
  • Weed DL. 2005. Weight of evidence: a review of concept and methods. Risk Anal. 25:1545–1557.
  • WHO. 1994. Glyphosate. Geneva: World Health Organization (WHO)/International Programme on Chemical Safety (IPCS)/United Nations Environment Program (UNEP) (Environmental Health Criteria, no 159). Available from: http://www.inchem.org/documents/ehc/ehc/ehc159.htm.
  • Williams GM. 1980. Classification of genotoxic and epigenetic hepatocarcinogens using liver culture assays. Ann NY Acad Sci. 349:273–282.
  • Williams GM, Iatropoulos MJ. 2002. Alteration of liver cell function and proliferation: differentiation between adaptation and toxicity. Toxicol Pathol. 30:41–53.
  • Williams GM, Iatropoulos MJ, Enzmann HG, Deschl UF. 2014. Carcinogenicity of chemicals. In: Hayes AW, Kruger CL, editors. Hayes’ principles and methods of toxicology. Boca Raton (FL): CRC Press Taylor & Francis Group; p. 1251–1303.
  • Williams GM, Berry C, Burns M, de Camargo JLV, Greim H. 2016. Glyphosate rodent carcinogenicity bioassay expert panel review. Crit Rev Toxicol, in this issue. doi: 10.1080/10408444.2016.1214679.
  • Williams GM, Kroes R, Munro IC. 2000. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans. Regul Toxicol Pharmacol. 31:117–165.