Agrochemical industry giants routinely conceal the toxicity of pesticides–to public health, animals and the environment–from the authorities called upon to assess their risks, with a view to authorizing their use.
A scientific study in the EU (Mie et al., 2023) and an investigation in the U.S. by Carey Gillam (author of the ‘Monsanto papers‘ investigation), in demonstrating this, highlight the ineffectiveness of procedures and the impunity of violators of established rules (1,2).
1) Pesticide toxicity and licensing procedures.
Toxicity to living organisms is a distinguishing characteristic of most active substances intended for use in agriculture as pesticides (a category that includes herbicides, fungicides, insecticides, rodenticides, fungicides, nematicides, acaricides, and phytoregulators).
Approval procedures for the use of such substances are therefore based, in the EU as in the U.S., on a safety assessment that includes toxicity and ecotoxicity analyses of pesticides. Analyses mostly performed or commissioned, it should be noted, by the producers themselves.
Producers in any case-at the time of application for authorization or its renewal-must submit to the authorities a dossier that includes all studies so far carried out by anyone on the toxicity of an active substance (pesticides, herbicides, etc.).
2) Concealed pesticide toxicity studies, the Swedish scientific study
Swedish researchers (Mie et al., 2023) focused on one type of pesticide toxicity, neurotoxicity in the developmental stage of nervous system structures and functions. To check whether the developmental neurotoxicity (DNT) studies of active substances-submitted by the agrochemical industry to the U.S. Environmental Protection Agency (EPA)-have also been disclosed to the European Food Safety Authority (EFSA).
Thirty-five studies on the neurotoxicity of certain active substances at the developmental stage of neurons have been submitted to the US authorities, but 9 of them–that is 26%, more than one in four–have not been forwarded by the agrochemical giants themselves to the EU authorities. Who thus concealed the toxicity of pesticides that would have had regulatory impact (authorization, conditions and limits of use) in at least 7 of the 9 cases identified.
2.1) Neurotoxicity testing in the developmental stage.
Developmental neurotoxicity (DNT) testing follows special technical guidelines, developed in the OECD to assess the toxicity of chemicals, including pesticides. (3) In vivo tests involve daily exposure of female rats to an active substance, at different doses, during pregnancy and lactation. Offspring are evaluated for neuropathological and behavioral changes.
Neurological disorders induced by pesticide toxicity are measured on:
- brain structure. Quantitative examination (size of different brain layers, morphometry) and qualitative examination (lesion analysis, histopathology),
- behavioral functions. Motor activity and its habituation, auditory startle reflex, learning and memory, ontogeny of at least two behaviors.
2.2) Developmental neurotoxicity, the limitations of in vivo tests in rodents
The limitations of in vivo rodent tests with regard to developmental neurotoxicity are related to the small number of behavioral functions evaluated. Significant toxic effects may therefore remain unnoticed.
The sensitivity of humans is in some cases greater, even substantially greater, than the doses administered to rodents. The assessment based on rodent tests may therefore underestimate the risk to humans. (4)
Developmental neurotoxicity (DNT) studies are in any case useful in demonstrating that a compound can disrupt neurodevelopment and should therefore always be considered in the evaluation of pesticide toxicity.
2.3) Information duties on pesticide toxicity.
European legislation-Regulation (EU) No 1107/2009 (concerning the placing of plant protection products on the market), Directive 91/414/EEC (concerning the placing of plant protection products on the market) -requires agrochemical industry operators to:
– Provide all pesticide toxicity studies, including DNTs (where available) and those that, considered in isolation, do not indicate significant or notable adverse effects,
To the submission of the application for authorization (or renewal) of the active substance,
– immediately inform member states where ‘plant protection products‘ (PPPs) are marketed, after their marketing authorization, whenever new information suggests that the approval criteria may no longer be met.
2.4) Pesticide toxicity concealment and scientific fraud
Bayer-Monsanto and Syngenta-two of the Big 4, the global monopolists in the agrochemical industry (5)-are the first to have concealed toxicity studies of their pesticides in the EU. This was followed by Nissan Chemicals and Ishihara Sangyo Kaisha (ISK) and others, including Italy’s Finchimica S.p.A.
The 9 active substances whose developmental neurotoxicity (DNT) studies hidden from EFSA(European Food Safety Authority) are abamectin, buprofezin, ethoprophos, fenamidone, fenamiphos, fluazinam, glyphosate (trimesium salt), pymetrozine, pyridaben.
2.5) Hidden toxicities, the case of apples in the Vinschgau Valley.
‘The following example illustrates how nondisclosure prevents authorities from protecting a vulnerable population group: the fungicide fluazinam is among the most widely used pesticides in intensive apple production in South Tyrol, northern Italy. (6) Fluazinam was also among the most frequently detected pesticides in grass samples from children’s playgrounds located in the vicinity of apple orchards and vineyards examined in this area in 2017 and 2018, apparently due to spray drift, volatilization, and/or through contaminated dust. (7)
At the 24 sites surveyed, the compound was detected at seven locations during spring sampling, 12 locations in summer, and none in fall and winter. These data suggestdirect (unintentional)exposure of residents in an intensive-use area. By not disclosing the DNT study, since 2005 the companies [ISK,Finchimica, ADAMA Makhteshim, ed.] have deprived EU authorities and, in this case, Italy, of the opportunity to assess whether such exposure is safe for the brain development of resident children ‘ (Mie et al., 2023). (8)
3) Scientific fraud and omissions
The ‘Monsanto papers‘ published by Carey Gillam revealed how the agrochemical giant – despite having exact knowledge of the serious public health risks related to glyphosate exposure for decades – had deliberately concealed them from authorities and farmers. (9) The Bayer-Monsanto group has therefore suffered some convictions, in the U.S., and is still grappling with a number of class actions. (10) The falsified studies produced by Bayer for the renewal of glyphosate authorization in the EU, conversely, still go unpunished. (11)
The scientific omissions and frauds about pesticide toxicity that have emerged so far, however, are most likely only the tip of the iceberg of the planet’s poisons. Given that the Swedish study is the first to systematically examine studies related to only one type of toxicity (DNT), and other scientific frauds have already emerged. These include testing for glyphosate toxicity at use doses at least half as low as current agricultural practices. (12) Not to mention viral deception strategies to conceal the genocide of bees and pollinators caused by neonicotinoids. (13)
3.1) Rules and regulatory gaps.
Transparency Regulation
(EU) No 2019/1381 introduced an obligation for economic operators, laboratories and other test facilities to notify EFSA of all studies to be carried out – as of March 27, 2021 – in preparation for an application or notification in relation to which EU law provides for a scientific opinion from the Authority (e.g., “The EFSA’s scientific opinion is required by EU law. pesticide toxicity, GMOs, but also food additives, novel foods).
The new demands of authorizations (or notifications for placing products on the EU market) are not considered valid or admissible if the studies supporting them have not been previously notified to EFSA, unless the applicant or notifier provides a valid justification for not notifying such studies (reg. EC 178/02, new Article 32b).
3.2) Hidden toxicities and renewals without risk assessment.
The reporting requirement for pesticide toxicity studies introduced in the
‘Transparency Regulation,’ it should be noted, has no retroactive effect. Therefore, this rule is not able to correct any bias in the evaluations performed by EFSA on the basis of incomplete dossiers when the concealed studies were initiated before March 27, 2021.
Among the 318 active substances approved in the EU today-microorganisms, commodities, and low-risk substances excluded-only 4 have been approved for the first time in the past 5 years. And therefore:
– at least 98.3 percent of dossiers may be flawed by omission of data on the toxicity of already authorized pesticides. Also,
– 33 percent of active substance approval renewals are not preceded by risk reassessment. Glyphosate is only one of 135 cases. (15)
3.3) Verification studies, the exception rather than the rule
The European legislature-regardless of the scientific frauds that have already widely emerged to conceal the toxicities of pesticides (see para. 3 above)-has limited itself to requiring that studies to be attached to permit applications be carried out in accordance with GLP(Good Laboratory Practices). And since such studies may be performed in the applicants’ own laboratories or in other private laboratories written by them, the risk of their distortion ‘to serve the outcome‘ is self-evident.
The scientific study under review (Mie et al., 2023) reports some examples, including misleading reporting of results on neurotoxicity of chlorpyrifos. (16) But the ‘Transparency Regulation‘ merely provides that the Commission, only ‘in exceptional circumstances of serious controversy or conflicting results, may ask the Authority to commission scientific studies with the aim of verifying the evidence used in its risk assessment process‘(Verification studies. New Article 32.d to reg. EC 178/02).
3.4) Reform needs
The research under review (Mie et al., 2023) therefore proposes a reform of the current rules so that pesticide toxicity studies are performed and/or commissioned to
– Public facilities (e.g., reference laboratories, universities),
or to
– private testing laboratories (in which case, upon demonstration of no conflict of interest, it is worth adding),
– By regulators rather than economic operators. With cost recovery from companies seeking approval.
Only ‘this approach can prevent the sponsor’s interest from influencing the outcome of toxicity studies and the challenges associated with pesticide safety assessment and public health (…). Similar solutions have been proposed for drug safety and efficacy testing‘. (17)
4) Paraquat and Parkinson’s disease, the correlations concealed by Syngenta
Big Ag ‘s crimes in the systematic concealment of studies and data on the toxicity of pesticides, herbicides and other agrotoxics find further confirmation in the strategies adopted by Syngenta to hide correlations between exposure to the weed-killer paraquat and the onset of Parkinson’s disease. (18) A series of internal documents-revealed in 2022 by The Guardian and New Lede-demonstrate that Imperial Chemical Industries (UK), then Chevron Chemical (US) and Syngenta (CH), had evidence as early as 1975 that paraquat could accumulate in the human brain. (19)
However, the agrochemical giants have implemented the strategy ‘Freedom to sell‘ – integrating scientific fraud, opaque relations with regulatory authorities, legal interventions, viral deception, on a planetary level – for continue sales of the deadly herbicide and Challenge the evidence on its severe toxicity, which led to its ban Both in the producing country (Switzerland) and in the EU. And restrictions on its professional use only in the US have not been enough to mitigate theepidemic of Parkinson’s disease, the prevalence of which more than doubled between 1990 and 2015. And it is now the fastest growing neurological disease globally, while paraquat continues to be used on several continents (1,19).
5) Interim Conclusions
Farmers e their families are the first victims of the toxicity-often concealed, as it turns out-of pesticides, herbicides and fungicides that pollute soils, waters (surface and underground) and the atmosphere, with ‘drift effect’ (pesticides drift) over long distances, as also demonstrated in apple crops in Trentino Alto Adige (Favaro et al., 2019). (20)
Those who are supposed to represent farmers, however, continue to favor the conflicting interests of pesticide and seed monopolists, perhaps partly because the resale of these inputs by agricultural consortiums registered with agricultural confederations is far more profitable than farming operations. (21) Ettore Prandini – president of Coldiretti, in Copa-Cogeca – went so far as to comment on the ‘Sustainable Use and Reduction of Pesticides Regulation‘ (SUR) and ‘Nature Restoration Law‘ (NRL) proposals as ‘ideological regulations with no scientific basis‘ (22,23,24). Any further comment is superfluous.
#CleanSpades
Dario Dongo
Notes
(1) Axel Mie, Christina Rudén (2023). Non-disclosure of developmental neurotoxicity studies obstructs the safety assessment of pesticides in the European Union. Environ Health 22, 44. https://doi.org/10.1186/s12940-023-00994-9
(2) Carey Gillam. Revealed: The secret push to bury a weedkiller’s link to Parkinson’s disease. https://www.theguardian.com/us-news/2023/jun/02/paraquat-parkinsons-disease-research-syngenta-weedkiller The Guardian. 2.6.23
(3) EFSA. Developmental neurotoxicity: in vivo testing and interpretation. https://www.efsa.europa.eu/en/events/developmental-neurotoxicity-vivo-testing-and-interpretation
(4) Martin Paparella, Susanne Hougaard Bennekou, Anna Bal-Price (2020). An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative approaches.
Reproductive Toxicology, 96, 2020, 327-336. https://doi.org/10.1016/j.reprotox.2020.08.002
(5) Dario Dongo. Seeds, the 4 masters of the world. GIFT (Great Italian Food Trade). 15.1.19
(6) Bayerischer Rundfunk: Apfelanbau: 38 Mal Pestizide in einer Saison. 2023. https://interaktiv.br.de/pestizide-im-apfel-anbau/
(7) Linhart, C., Panzacchi, S., Belpoggi, F. et al. Year-round pesticide contamination of public sites near intensively managed agricultural areas in South Tyrol. Environ Sci Eur 33, 1 (2021). https://doi.org/10.1186/s12302-020-00446-y
(8) Alessandra Mei. Apples to pesticides, the Val Venosta case. https://www.greatitalianfoodtrade.it/sicurezza/mele-ai-pesticidi-il-caso-val-venosta/ GIFT (Great Italian Food Trade). 21.3.23
(9) Dario Dongo. Glyphosate, European Chemical Agency Echa report overlooks the falsity of data produced by Monsanto. Corporation now on trial in U.S.. GIFT (Great Italian Food Trade). 17.3.17
(10) Dario Dongo. Glyphosate, Bayer allocates $16 billion but convictions are upheld on appeal. GIFT (Great Italian Food Trade). 11.8.21
(11) Dario Dongo, Fabrizio Adorni. Glyphosate, the fake studies used by Bayer for authorization renewal. GIFT (Great Italian Food Trade). 8.12.19
(12) Dario Dongo. Glyphosate and GMO soybeans, the big scam. Scientific study. GIFT (Great Italian Food Trade). 6.1.20
(13) Marina De Nobili, Dario Dongo. Neonicotinoids, investigation of pesticide lobbies. GIFT (Great Italian Food Trade). 7.7.20
(14) Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC https://eur-lex.europa.eu/eli/reg/2019/1381/oj.
(15) Marta Strinati. Not just glyphosate. 33% of pesticides used in EU lack risk assessment. GIFT (Great Italian Food Trade). 26.11.22
(16) Dario Dongo, Marta Strinati. Chlorpyrifos, the pesticide that damages children’s brains. Class action in the US, waivers in Italy. GIFT (Great Italian Food Trade). 26.7.21
(17) Marc A. Rodwin (2015). Independent drug testing to ensure drug safety and efficacy. https://digitalcommons.law.umaryland.edu/cgi/viewcontent.cgi?article=1327&context=jhclp J Health Care Law & Policy. 2015;18:45
(18) Dario Dongo. Paraquat, the agrotoxic Made in Europe. GIFT (Great Italian Food Trade). 26.8.17
(19) Carey Gillam, Aliya Uteuova. Secret files suggest chemical giant feared weedkiller’s link to Parkinson’s disease. https://www.theguardian.com/us-news/2022/oct/20/syngenta-weedkiller-pesticide-parkinsons-disease-paraquat-documents The Guardian. 20.10.22
(20) Dario Dongo. The drift effect of pesticides on bees, trees and plants away from cropland. GIFT (Great Italian Food Trade). 21.12.20
(21) Dario Dongo, Marta Strinati. Post-2020 CAP, environment and health at risk. Appeal to the EU Parliament. GIFT (Great Italian Food Trade). 16.10.20
(22) TEA: Prandini (Coldiretti), Brussels speed up presentation of new regulation. https://www.agrapress.it/2023/06/tea-prandini-coldiretti-bruxelles-acceleri-presentazione-nuovo-regolamento Agrapress. 6.6.23
(23) Alessandra Mei. Regulation on the sustainable use of pesticides, SUR. The travails of EU reform. GIFT (Great Italian Food Trade). 20.12.22
(24) Dario Dongo. Nature Restoration Law, European Parliament boycotts biodiversity restoration. GIFT (Great Italian Food Trade). 3.6.23
(25) Dario Dongo, Donato Ferrucci. Pesticides, acute toxicity in the US agricultural system. Scientific study. GIFT (Great Italian Food Trade). 25.8.19
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
