References
BAuA (Federal Institute for Occupational Safety and Health as Dossier Submitter under the Regulation (EC) No 1272/2008) (2016) CLH report. Proposal for harmonised classification and labelling based on regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2. Substance Name: N-(phosphonomethyl)glycine; Glyphosate (ISO). EC Number: 213-997-4. CAS Number: 1071-83-6. Index Number: 607-315-00-8. Version: 2.0 (Post Accordance Check). Date: May 2016. https://echa.europa.eu/documents/10162/9fb5d873-2034-42d9-9e53-e09e479e2612
ECHA (European Chemicals Agency) (2015) Guidance on the application of the CLP Criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. Version 4.1. ECHA-15-G-05-EN. Helsinki
ECHA (European Chemicals Agency) (2017) Committee for risk assessment (RAC) opinion proposing harmonised classification and labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine. EC Number: 213-997-4, CAS Number: 1071-83-6, CLH-O-0000001412-86-149/F. Adopted 15 March 2017. https://echa.europa.eu/documents/10162/2d3a87cc-5ca1-31d6-8967-9f124f1ab7ae
EFSA (European Food Safety Authority) (2015a) Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate. EFSA J 13:4302, 107pp. doi:10.2903/j.efsa.2015.4302. http://www.efsa.europa.eu/en/efsajournal/pub/4302
EFSA (European Food Safety Authority), 2015b. Peer review report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance glyphosate. http://registerofquestions.efsa.europa.eu/roqFrontend/outputLoader?output=ON-4302
EFSA Scientific Committee (2011) Statistical Significance and Biological Relevance. EFSA J 9(9):2372. doi:10.2903/j.efsa.2011.2372
Germany (Rapporteur Member State under the Regulation (EC) No 1107/2009) (2015) Final addendum to the renewal assessment report on glyphosate. Available through EFSA Register of Questions http://registerofquestions.efsa.europa.eu/roqFrontend/outputLoader?output=ON-4302
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(3):185–208
IARC (International Agency for Research on Cancer) (1992) International classification of rodent tumours. Part 1: The rat. 2. Soft tissue and musculoskeletal system. Ed by Mohr, U. Corporate Body: International Agency for Research on Cancer -IARC-, Lyon. Imprint Lyon: IARC, 1992, 62 pp. IARC Scientific Publications, 122. ISBN: 92-832-0122-1
IARC (International Agency for Research on Cancer) (2006) Monographs on the evaluation of carcinogenic risks to human. Preamble.. IARC Working Group. Lyon, 2006
IARC (International Agency for Research on Cancer) (2017) Some organophosphate insecticides and herbicides/IARC Working Group on the evaluation of carcinogenic risks to humans (IARC monographs on the evaluation of carcinogenic risks to humans; volume 112). (2015: Lyon, France) ISBN 978-92-832-0178-6 ISSN 1017-1606
Liang CT, Shih A, Chang YH, Liu CW, Lee YT, Hsieh WC, Huang YL, Huang WT, Kuang CH, Lee KH, Zhuo YX, Ho SY, Liao SL, Chiu YY, Hsu CN, Liang SC, Yu CK (2009) Microbial contaminations of laboratory mice and rats in Taiwan from 2004 to 2007. J Am Assoc Lab Anim Sci 48(4):381–386
Manjunath S, Kulkarni PG, Nagavelu K, Samuel RJ, Srinivasan S et al (2015) Sero-prevalence of rodent pathogens in India. PLoS One 10(7):e0131706. doi:10.1371/journal.pone.0131706
Marx JO, Brice AK, Boston RC, Smith AL (2013) Incidence rates of spontaneous disease in laboratory mice used at a large biomedical research institution. J Am Assoc Lab Anim Sci 52(6):782–791
OECD (Organisation for Economic Co-operation and Development) (1998) OECD series on principles of good laboratory practice and compliance monitoring. Number 1. OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17
OECD (Organisation for Economic Co-operation and Development) (2012) Guidance document on the conduct and design of chronic toxicity and carcinogenicity studies, supporting test guidelines 451, 452 and 453. Environment, Health and Safety Publications, Series on Testing and Assessment No. 116. 2ND EDITION. Environment Directorate, ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, Paris 2012 1
Portier CJ, Clausing P (2017) Re: Tarazona et al. (2017): Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC. doi: 10.1007/s00204-017-1962-5. Arch Toxicol. doi:10.1007/s00204-017-2009-7
Pritchett-Corning KR, Cosentino J, Clifford CB (2009) Contemporary prevalence of infectious agents in laboratory mice and rats. Lab Anim 43(2):165–173. doi:10.1258/la.2008.008009
Tarazona JV, Court-Marques D, Tiramani M, Reich H, Pfeil R, Istace F, Crivellente F (2017) Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC. Arch Toxicol 91(8):2723–2743
USEPA (US Environmental Protection Agency) (2016) Glyphosate issue paper: evaluation of carcinogenic potential. EPA’s Office of Pesticide Programs. September 12, 2016. https://www.epa.gov/sites/production/files/2016-09/documents/glyphosate_issue_paper_evaluation_of_carcincogenic_potential.pdf
WHO (World Health Organisation) (2009) Handbook: good laboratory practice (GLP) quality practices for regulated non-clinical research and development, 2nd ed. ISBN 978 92 4 154755 0
Acknowledgements
The authors are staff personnel of the European Food Safety Authority. The authors declare no competing financial interests. The content of this paper is of the exclusive responsibility of the authors; the opinion of the Authority is that presented in the EFSA Conclusion and institutional documents. The authors want to thank the contributions from Dr Roland Solecki, Head of Department Chemicals Safety at the German Federal Institute for Risk Assessment (BfR) and from several colleagues at the European Food Safety Authority and the European Chemicals Agency.
Author information
Authors and Affiliations
Corresponding author
Additional information
This reply refers to the original article available at: 10.1007/s00204-017-1962-5.
Rights and permissions
About this article
Cite this article
Tarazona, J.V., Court-Marques, D., Tiramani, M. et al. Response to the reply by C. J. Portier and P. Clausing, concerning our review “Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC”. Arch Toxicol 91, 3199–3203 (2017). https://doi.org/10.1007/s00204-017-2032-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00204-017-2032-8