Approval procedure for active substances in plant protection products - doubts of scientific certainty as a source of controversy. Analysis of systemic imperfections on the example of glyphosate

Authors

  • Anna Gembicka University of Białystok, Poland
  • Jakub Ali Farhan University of Białystok, Poland

DOI:

https://doi.org/10.15290/eejtr.2022.06.01.04

Keywords:

active substance approval, pesticides, glyphosate

Abstract

The purpose of this article is to examine the causes of recurring doubts regarding the safety of plant protection products used in the European Union. Plant protection products are a particular subject of regulation. All standards concerning them require prior in-depth scientific research in the field of exact sciences. Achieving adequate safety of humans, animals and the environment in connection to the use of plant protection products requires not only good law, but a law based on representative research and scientific certainty. Bearing in mind the above, the authors undertook an analysis of what seems to be the cause of significant social doubts as to the actual achievement of the purposes of Regulation 1107/2009, i.e. inclusion of scientific research in the procedure of approval of active substances in plant protection products. First, the approval procedure for the active substance of the plant protection product was presented, and then the main shortcoming of the procedure was analyzed on the example of the approval of glyphosate. In the authors' opinion, guidance documents on literature review should be revised to reflect the best scientific practice, and their standards should be enforced, in particular, to ensure that there is no doubt about the objectivity of the literature review.

Downloads

Download data is not yet available.

Author Biographies

References

Antoniou, M., Habib, M. E. E. M., Howard, C. V., Jennings, R. C., Leifert, C., Nodari, R. O., Robinson, C., & Fagan, J. (2011). Roundup and Birth Defects: Is the Public Being Kept in the Dark?. Earth Open Source. http://earthopensource.org/earth-open-source-reports/roundup-and-birth-defects-is-the-public-being-kept-in-the-dark/.

Bellanger, M., Demeneix, B., Grandjean, P., Zoeller, R. T., & Trasande, L. (2015). Neurobehavioral Deficits, Diseases, and Associated Costs of Exposure to Endocrine-Disrupting Chemicals in the European Union. The Journal of Clinical Endocrinology & Metabolism, 100(4), 1256–1266. https://doi.org/10.1210/jc.2014-4323.

Buonsante, V.A., Muilerman, H., Santos, T., Robinson, C., & Tweedale, A. C. (2014). Risk Assessment’s Insensitive Toxicity Testing May Cause It to Fail. Environmental Research, 135, 139-47. https://doi:10.1016/j.envres.2014.07.016.

Clausing, P. (2017). Glyphosate and Cancer: Authorities Systematically Breach Regulations. GLOBAL 2000. Available at: http://www.gmwatch.org/files/GLO_02_Glyphosat_EN.pdf.

De Roos, A.J. et al. (2003). Integrative assessment of multiple pesticides as risk factors for non-Hodgkin’s lymphoma among men. Occupational and Environmental Medicine, 60(9), 11e–111. https://doi.org/10.1136/oem.60.9.e11.

de Sadeleer, N. (2006). The Precautionary Principle in EC Health and Environmental Law. European Law Journal 12(2), 139-172. https://doi.org/10.1111/j.1468-0386.2006.00313.x.

European Chemicals Agency (ECHA). (2017). Opinion of the Committee for Risk Assessment proposing harmonised classification and labelling of glyphosate (ISO); N-(phosphonomethyl)glycine. (EC Number: 213-997-4; CAS Number: 1071-83-6). Available at: https://echa.europa.eu/documents/10162/2f8b5c7f-030f-5d3a-e87e-0262fb392f38.

European Citizens’ Initiative (n.d.). Ban Glyphosate and Protect People and the Environment from Toxic Pesticides. Available at: http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2017/000002.

European Commission. (2000). Communication from the Commission on the Precautionary Principle, COM/2000/0001 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52000DC0001&from=EN.

European Commission. (2017). Communication from the Commission on the European Citi-zens' Initiative, Ban glyphosate and protect people and the environment from toxic pesticides, C(2017) 8414 final, Strasbourg, available at: https://ec.europa.eu/food/system/files/2017-12/pesticides_glyphosate_eci_final.pdf.

European Food Safety Authority (EFSA). (2011). Submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal, 9(2). https://doi.org/10.2903/j.efsa.2011.2092.

European Food Safety Authority (EFSA). (2015). Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate. EFSA Journal, 13(11). https://doi.org/10.2903/j.efsa.2015.4302.

European Food Safety Authority (EFSA). (2017). Pesticide Residues in Food: Risk to Consumers Remains Low. Available at: http://www.efsa.europa.eu/en/press/news/170411.

European Parliament. (2017). Renewing the Approval of the Active Substance Glyphosate, European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D053565-01 – 2017/2904(RSP)), P8_TA(2017)0395. Available at: https://www.europarl.europa.eu/doceo/document/TA-8-2017-0395_EN.html.

European Parliament. (2017). Sustainable Use of Pesticides, European Parliament resolution of 12 February 2019 on the implementation of Directive 2009/128/EC on the sustainable use of pesticides. (2017/2284(INI)), P8_TA-PROV(2019)0082. Available at: https://www.europarl.europa.eu/doceo/document/TA-8-2019-0082_EN.html.

Gee, D. (2006). Late Lessons from Early Warnings: Toward Realism and Precaution with Endocrine-Disrupting Substances. Environmental Health Perspectives, 114(Suppl 1), 152–160. https://doi.org/10.1289/ehp.8134.

George, J., Prasad, S., Mahmood, Z., & Shukla, Y. (2010). Studies on glyphosate-induced carcinogenicity in mouse skin: A proteomic approach. Journal of Proteomics, 73(5), 951–964. https://doi.org/10.1016/j.jprot.2009.12.008.

Hallmann, C.A., Sorg, M., Jongejans, E., Siepel, H., Hofland, N., Schwan, H., Stenmans, W., Müller, A., Sumser, H., Hörren, T., Goulson, D., & de Kroon, H. (2017). More than 75 percent decline over 27 years in total flying insect biomass in protected areas. PLOS ONE, 12(10), e0185809. https://doi.org/10.1371/journal.pone.0185809.

Ingre-Khans, E., Ågerstrand, M., Beronius, A., & Rudén, C. (2019). Reliability and relevance evaluations of REACH data. Toxicology Research, 8(1), 46–56. https://doi.org/10.1039/c8tx00216a.

International Agency for Research on Cancer. (2015). IARC Monographs Volume 112: Evaluation of Five Organophosphate Insecticides and Herbicides. World Health Organization. Available at: https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-4/.

Kaltenhäuser, J., Kneuer, C., Marx-Stoelting, P., Niemann, L., Schubert, J., Stein, B., & Solecki, R. (2017). Relevance and reliability of experimental data in human health risk assessment of pesticides. Regulatory Toxicology and Pharmacology, 88, 227–237. https://doi.org/10.1016/j.yrtph.2017.06.010.

Kase, R., Korkaric, M., Werner, I., & Ågerstrand, M. (2016). Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies. Environmental Sciences Europe, 28(1). https://doi.org/10.1186/s12302-016-0073-x.

Krauth, D., Woodruff, T. J., & Bero, L. (2013e). Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review. Environmental Health Perspectives, 121(9), 985–992. https://doi.org/10.1289/ehp.1206389.

MarketsandMarkets. (2020). Glyphosate Market – Global Forecast to 2022. Available at: https://www.marketsandmarkets.com/Market-Reports/glyphosate-market-8522593.html.

Mostafalou, S., & Abdollahi, M. (2016). Pesticides: an update of human exposure and toxicity. Archives of Toxicology, 91(2), 549–599. https://doi.org/10.1007/s00204-016-1849-x.

Myers, J.P., 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(3), 309–315. https://doi.org/10.1289/ehp.0800173.

Navarrete-Meneses, M.D.P., & Pérez-Vera, P. (2019). Pyrethroid pesticide exposure and hematological cancer: epidemiological, biological and molecular evidence. Reviews on Environmental Health, 34(2), 197–210. https://doi.org/10.1515/reveh-2018-0070.

Organisation for Economic Cooperation and Development (OECD). (2015). General Questions and Answers Concerning OECD Principles of Good Laboratory Practice (GLP) and Mutual Acceptance of Data (MAD). Available at: https://tinyurl.com/yy8czckz.

Pesticide Action Network Europe and Générations Futures. (2014). Missed and Dismissed. Available at: http://www.pan-europe.info/old/Resources/Reports/PANE%20-%202014%20-%20Missed%20and%20dismissed.pdf.

Pesticide Action Network Europe. (2017). How Many Pesticides Did You Eat Today? Plenty According to European Food Safety Authority. Available at: https://www.pan-europe.info/press-releases/2017/04/how-many-pesticides-did-you-eat-today-plenty-according-european-food-safety.

Pesticide Action Network Germany and Testbiotech. (2015). Does Glyphosate Cause Cancer? Important Gap in German Risk Assessment. Available at: https://tinyurl.com/y4wxl6dd.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

RMS Germany (German Federal Institute for Risk Assessment, BfR). (2015). Renewal Assessment Report: Glyphosate Addendum 1 to RAR: Assessment of IARC Monographs Volume 112 (2015): Glyphosate. Available at: http://www.gmwatch.org/files/Renewal_Assessment_Report_Glyphosate_Addendum1_RAR.pdf.

Stehle, S. & Schulz, R. (2015). Pesticide Authorisation in the EU – environment unprotected? Environmental Science and Pollution Research International, (22)24, 19632-47. https://doi.org/10.1007/s11356-015-5148-5.

Weber, S., & Burtscher-Schaden, H. (2019). Detailed Expert Report on Plagiarism and Superordinated Copy Paste in the Renewal Assessment Report (RAR) on Glyphosat. Available at: https://left.eu/content/uploads/2019/01/Expertise-RAR-Glyphosat-2018-01-11-1.pdf.

Woodcock, B.A., Isaac, N.J.B., Bullock, J.M., Roy, D.B., Garthwaite, D.G., Crowe, A., & Pywell, R.F. (2016). Impacts of neonicotinoid use on long-term population changes in wild bees in England. Nature Communications, 7(1). https://doi.org/10.1038/ncomms12459.

Woodruff, T.J., & Sutton, P. (2014). The Navigation Guide Systematic Review Methodology: A Rigorous and Transparent Method for Translating Environmental Health Science into Better Health Outcomes. Environmental Health Perspectives, 122(10), 1007–1014. https://doi.org/10.1289/ehp.1307175.

Downloads

Published

2023-04-23

Issue

Section

Articles

How to Cite

Approval procedure for active substances in plant protection products - doubts of scientific certainty as a source of controversy. Analysis of systemic imperfections on the example of glyphosate. (2023). Eastern European Journal of Transnational Relations, 6(1), 49-57. https://doi.org/10.15290/eejtr.2022.06.01.04