Abstract

Introduction

The registration of pesticides that allows their use and consumption, commercialization, and production, import and export in Brazil is granted by the Ministry of the Environment and the Ministry of Agriculture, Livestock and Supply of Brazil after the authorization of three regulatory bodies: the Brazilian Health Regulatory Agency (Anvisa), of the Brazilian Ministry of Health; the Brazilian Institute of Environment and Renewable Natural Resources (Ibama); and Ministry of Agriculture, Livestock and Supply, which are the bodies that assess the potential impacts on health, the environment and agronomic efficiency, respectively ¹1. Brasil. Lei nº 7.802, de 11 de julho de 1989. Dispõe sobre a pesquisa, a experimentação, a produção, a embalagem e rotulagem, o transporte, o armazenamento, a comercialização, a propaganda comercial, a utilização, a importação, a exportação, o destino final dos resíduos e embalagens, o registro, a classificação, o controle, a inspeção e a fiscalização de agrotóxicos, seus componentes e afins, e dá outras providências Diário Oficial da União 1989; 12 jul.^,22. Brasil. Decreto nº 4.074, de 4 de janeiro de 2002. Regulamenta a Lei nº 7.802, de 11 de julho de 1989, que dispõe sobre a pesquisa, a experimentação, a produção, a embalagem e rotulagem, o transporte, o armazenamento, a comercialização, a propaganda comercial, a utilização, a importação, a exportação, o destino final dos resíduos e embalagens, o registro, a classificação, o controle, a inspeção e a fiscalização de agrotóxicos, seus componentes e afins, e dá outras providências. Diário Oficial da União 2002; 8 jan..

In this context, some effects on human health, such as genetic mutation, effects on the reproductive system, teratogenicity, hormonal disorders, and cancer, are considered prohibitive for the purposes of registration, as provided for in the letters “c” and “d”, §6, Art. 3, of Law n. 7,082/1989¹1. Brasil. Lei nº 7.802, de 11 de julho de 1989. Dispõe sobre a pesquisa, a experimentação, a produção, a embalagem e rotulagem, o transporte, o armazenamento, a comercialização, a propaganda comercial, a utilização, a importação, a exportação, o destino final dos resíduos e embalagens, o registro, a classificação, o controle, a inspeção e a fiscalização de agrotóxicos, seus componentes e afins, e dá outras providências Diário Oficial da União 1989; 12 jul.. The observation of these effects leads to the ban of such pesticides in the process of registration review and the dismissal of new active substances.

Nevertheless, there is no legal provision in Brazil for a minimum periodicity for the reevaluation of registration. According to Decree n. 4,074/2002, theoretically, this review could occur at any time, guided by international warnings, new scientific studies or complaints made by reference institutions, under the terms of item VI, art. 2. Within the scope of Anvisa, the toxicological reassessment is carried out according to criteria established in the Resolution of the Collegiate Board - RDC n. 221 of March 28, 2018³3. Ministério da Saúde; Agência Nacional de Vigilância Sanitária. RDC nº 221, de 28 de março de 2018. Diário Oficial da União 2018; 29 mar.; however, the norm does not provide for minimum periodicity or the deadline for its conclusion as well.

Nevertheless, it is clear that, even in cases of international warnings, the limitation of resources available in the agencies or the legal actions carried out by corporations linked to agribusiness often hinder and delay such reviews, aggravating the situation of population’s exposure to these dangerous products ⁴4. Franco CR, Pelaez V. Constructing the political agenda of control over pesticides in Brazil. Ambiente & Sociedade 2016; 1:215-32..

In addition to the fragility of the current Brazilian regulatory context, recent proposals to change the legislation ⁵5. Câmara dos Deputados. Projeto de Lei nº 6.299/2002. Altera os arts 3º e 9º da Lei no 7.802, de 11 de julho de 1989, que dispõe sobre a pesquisa, a experimentação, a produção, a embalagem e rotulagem, o transporte, o armazenamento, a comercialização, a propaganda comercial, a utilização, a importação, a exportação, o destino final dos resíduos e embalagens, o registro, a classificação, o controle, a inspeção e a fiscalização de agrotóxicos, seus componentes e afins, e dá outras providências. https://www.camara.leg.br/proposicoesWeb/fichadetramitacao?idProposicao=46249 (acessado em 04/Jun/2020).
https://www.camara.leg.br/proposicoesWeb... point to flexibility, a fact that has been worrying research institutions, legal entities, democratic interests, and social organizations, especially with the national expansion of commercialization products that are not used in other countries ⁶6. Carneiro FF, Rigotto RM, Augusto LGS, Friedrich K, Burigo AC. Dossiê Abrasco: um alerta sobre os impactos dos agrotóxicos na saúde. Rio de Janeiro: Escola Politécnica em Saúde Joaquim Venâncio, Fundação Oswaldo Cruz/São Paulo: Expressão Popular; 2015.. Within this context, Brazil may consolidate itself as a large market for obsolete products, which can cause damage to the exposed population and biodiversity ⁷7. Porto MFS. O trágico Pacote do Veneno: lições para a sociedade e a Saúde Coletiva. Cad Saúde Pública 2018; 34:e00110118..

Taking this into consideration, the objective of this study was to identify and analyze the profile of the active substances of pesticides registered in Brazil and their international regulatory status in member countries of the Organisation for Economic Co-operation and Development (OECD), the European Community, India, and China, identifying the associated potential damages to health and the environment.

Methodology

This study is a documentary research. The pesticide active substances authorized in Brazil were identified based on the consultation of the list of authorized monographs, available on the Anvisa website. Of these, microbiological products and biological control agents were excluded from the study.

Based on the Anvisa monographs, pesticide active substances were identified in terms of the following aspects: chemical group, acute toxicity classification, indication of use, and approval status for other uses (nonagricultural, over-the-counter or specialized sale of household cleaning products; use in public health campaigns, use in amateur gardening, and application as a wood preservative). Those exclusively intended for nonagricultural uses were excluded from the study.

To identify the carcinogenicity of pesticide active substances authorized in Brazil, the classification lists of the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) ⁸8. International Agency for Research on Cancer. Pentachlorophenol and some related compounds. (IARC Monographs on the Identification of Carcinogenic Hazards to Humans 2019; 117). https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Pentachlorophenol-And-Some-Related-Compounds-2019.(acessado em 11/Jun/2020).
https://publications.iarc.fr/Book-And-Re... and of the US Environmental Protection Agency (USEPA) ⁹9. United States Environmental Protection Agency. Chemicals evaluated for carcinogenic potential annual cancer report. http://npic.orst.edu/chemicals_evaluated.pdf (acessado em 11/Jun/2020).
http://npic.orst.edu/chemicals_evaluated... were consulted. Lists of the European Community were also searched for pesticide candidates for substitution ¹⁰10. Directorate General for Health and Consumers, European Commission. Ad-hoc study to support the initial establishment of the list of candidates for substitution as required in Article 80 (7) of Regulation (EC) n 1107/2009. Final report. https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_cfs_report-201307.pdf (acessado em 11/Jun/2020).
https://ec.europa.eu/food/sites/food/fil... and those potentially endocrine disruptors ¹¹11. European Commission. Which substances are of concern? https://ec.europa.eu/environment/chemicals/endocrine/strategy/substances_en.htm#sub1 (acessado em 12/Jun/2020).
https://ec.europa.eu/environment/chemica... .

For the research, pesticides with the highest volume of commercialization in Brazil in 2017 were highlighted, based on the commercialization report available on the IBAMA website (https://www.ibama.gov.br/index.php).

Registration information was collected for 35 of the 36 OECD member countries (Australia, Canada, Chile, United States, Iceland, Israel, Japan, Mexico, New Zealand, Norway, Switzerland, Turkey, United Kingdom, and the European Community bloc, which includes 22 OECD member countries), and two countries of the BRICS bloc, India and China, whose databases were available in English. The United Kingdom ceased to be part of the European Community during the course of this study, but health and safety information remains unchanged until December 31, 2020. Although South Korea is an OECD member country, its data were not included due to the difficulty in accessing the active substances of authorized pesticides on the country’s official website.

Information regarding the registration situation in Brazil and in other countries was collected on the websites of the respective official bodies, from May 15, 2017 to August 31, 2019: Australian Pesticides and Veterinary Medicines Authority (https://portal.apvma.gov.au/pubcris;jsessionid=3WzzhEaPP5w4Pd19oL+xuTkv); Anvisa (http://portal.anvisa.gov.br/registros-e-autorizacoes/agrotoxicos/produtos/monografia-de-agrotoxicos/autorizadas); Health Canada (http://pr-rp.hc-sc.gc.ca/pi-ip/index-eng.php); Agricultural and Livestock Service, Chile (Servicio Agrícola y Ganadero - http://www.sag.cl/ambitos-de-accion/evaluacion-y-autorizacion-de-plaguicidas/1367/registros); Food Safety-Plants-Pesticides-Pesticides Database, European Community (http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=homepage&language=EN); The Environmental Agency of Iceland (https://www.ust.is/english/chemicals/biocides/active-substances/); Ministry of Agriculture & Farmers Welfare, India (http://ppqs.gov.in/sites/default/files/registeried_formulation_29.02.2020.pdf); Ministry of Agriculture and Rural Development, Israel (http://www.hadbara.moag.gov.il/hadbara/english/search/NoKotelForm.asp); Food and Agricultural Materials Inspection Center, Japan (http://www.acis.famic.go.jp/eng/ailist/index.htm); Federal Commission for the Protection against Sanitary Risks, Mexico (Comisión Federal para la Protección contra Riesgos Sanitarios - http://siipris03.cofepris.gob.mx/Resoluciones/Consultas/ConWebRegPlaguicida.asp); Norwegian Food Safety Authority (https://www.mattilsynet.no/plantevernmidler/godk.asp?sortering=virkestoff&preparat=Alle&sprak=In%20English); Ministry for Primary Industries - Manatu Ahu Matua - New Zealand government (https://eatsafe.nzfsa.govt.nz/web/public/acvm-register); Federal Office for Agriculture, Switzerland (Bundesamt fur Landwirtschaft - Pflanzenschutzmittelverzeichnis, https://www.psm.admin.ch/de/wirkstoffe); Ministry of Food, Agriculture and Livestock, Turkey (https://bku.tarim.gov.tr/BKURuhsat/Index).

Information on the registration situation in the United States was obtained from the Pesticide Database available from the Pesticide Action Network (PAN) (http://www.pesticideinfo.org/Search_Chemicals.jsp#ChemSearch); as for China, information was obtained from a document published by the Food and Agriculture Organization (FAO) ¹²12. Food and Agriculture Organization of the United Nations. Progress in pesticide risk assessment and phasing-out of highly hazardous pesticides in Asia (2015). http://www.fao.org/3/a-i4362e.pdf (acessado em 12/Jun/2020).
http://www.fao.org/3/a-i4362e.pdf... .

In all databases, the registration status of each pesticide active substances authorized in Brazil was researched. Those that were unauthorized in the European Community and/or in at least 3 OECD member countries were highlighted. This prominence is based on one of the proposed amendments to Law n. 7,802/1989, which authorizes the granting of temporary pesticides active substances registration in Brazil approved in at least three OECD member countries, in case the regulatory bodies do not evaluate registration dossiers in 24 months ⁵5. Câmara dos Deputados. Projeto de Lei nº 6.299/2002. Altera os arts 3º e 9º da Lei no 7.802, de 11 de julho de 1989, que dispõe sobre a pesquisa, a experimentação, a produção, a embalagem e rotulagem, o transporte, o armazenamento, a comercialização, a propaganda comercial, a utilização, a importação, a exportação, o destino final dos resíduos e embalagens, o registro, a classificação, o controle, a inspeção e a fiscalização de agrotóxicos, seus componentes e afins, e dá outras providências. https://www.camara.leg.br/proposicoesWeb/fichadetramitacao?idProposicao=46249 (acessado em 04/Jun/2020).
https://www.camara.leg.br/proposicoesWeb... .

The survey also sought to identify the technical reasons for ban in Europe for pesticide active substances whose commercialization data for the year 2017 were made available and published through reports on the Ibama website, deepening the qualitative aspect of the study.

Results

General profile of pesticides active substances authorized in Brazil

On the Anvisa website, we found 450 authorized monographs of chemical, biochemical, semi-chemical, microbiological pesticide active substances and biological control agents authorized in Brazil.

For this study, we only considered pesticide active substances classified as chemical and semi-chemical, totaling 401 pesticide active substances, including paraquat in this list, which was banned in Brazil on September 22, 2020.

We identified metabolites in some monographs, which are recognized as active ingredients in products commercialized in Brazil or in other countries and, therefore, were individually treated, totaling 458 pesticide active substances. Of these, we observed that 318 are exclusively used for agricultural purposes; 59, for nonagricultural purposes; 78, for both agricultural and nonagricultural purposes; and three (3) are exclusively authorized for export (the herbicides aclonifen, bromoxynil, and diflufenicam). Considering that the surveyed international databases refer to products authorized for agriculture use, those for exclusive nonagricultural use were excluded, totaling 399 pesticide active substances surveyed.

Among the 78 pesticide active substances that are permitted for agricultural and nonagricultural use, 54 are permitted for household use, 24 of which are authorized for over-the-counter sale and 13 for specialized restricted sale. Use in public health campaigns is permitted for 27 pesticide active substances. A total of 25 pesticide active substances are authorized for amateur gardening, and eight (8), for use as wood preservatives in addition to the permission for agricultural use.

Chronic health effects and environmental impacts

Of the total 399 active substances considered in this study, 116 were directly related to chronic effects on human health or the environment. According to the list of carcinogenic potential assessment of USEPA ⁷7. Porto MFS. O trágico Pacote do Veneno: lições para a sociedade e a Saúde Coletiva. Cad Saúde Pública 2018; 34:e00110118., 52 pesticide active substances were classified as “probable” or “possible” carcinogens for humans, of which four (4) had reservations about the level of exposure or the type of effect. A total of 16 pesticide active substances had evidence suggestive of the carcinogenic potential for humans, whereas another 8 had evidence suggestive of carcinogenicity, but without enough information to assess the carcinogenic potential for humans (Box 1). The nomenclature of the different classes of carcinogenic potential of USEPA has been updated, in such a way there are pesticides with similar potentials to cause cancer, but allocated in different classes.

The IARC analyzed 36 pesticide active substances and, of this total, 15 pesticide active substances are authorized for use in Brazil, with diazinon, glyphosate, and malathion being classified as probable carcinogens (group 2A), and chlorotanolil and 2,4-D as possible carcinogens (group 2B) (Box 1).

Among the pesticide active substances classified according to endocrine disruption, 17 were classified as potential for humans or wildlife, namely: category 1 - evidence of endocrine disruption in in vivo studies; category 2 - evidence of endocrine disruption in in vitro studies; category 3 - without evidence of endocrine disruption or without available data (Box 1). It is noteworthy that some pesticide active substances were simultaneously classified in more than one category (alachlor, atrazine, 2,4-D, and malathion), in such a way that 5 were classified in category 1 (4 for humans and 1 for wildlife) and 15, in category 2 (9 for humans and 6 for wildlife) (Box 1). In the list of 77 pesticide candidates for substitution of the European Community, 68% are authorized in Brazil.

Pesticide active substances authorized in Brazil and unauthorized in other countries

Of the total active substances studied and authorized in Brazil, 3.5% (n = 14) (abamectin, clethodim, dicamba, dimethomorph, glyphosate, imidacloprid, lambda-cyhalothrin, MCPA, metribuzin, metalaxyl-M, propamocarb, tebuconazole, thiaclopride, and thiophanate-methyl) are approved in all OECD member countries. When including the studied BRICS countries, this number decreases to 12, as we observed that clethodim and dicamba are unauthorized for use in India.

A total of 17 pesticide active substances are unauthorized in all OECD member countries, and 16 pesticide active substances are unauthorized in China and India as well. We observed that 81% of pesticides authorized in Brazil have no use permit in at least three OECD countries, and 31% are not approved in China and India.

The percentage of unauthorized pesticide active substances or those that were not found in the countries’ databases for product authorization was: 85.7% in Iceland; 84.7% in Norway; 54.5% in Switzerland; 52.6% in India; 45.6% in Turkey; 44.4% in Israel; 43.4% in New Zealand; 42.4% in Japan; 41.5% in the European Community; 39.6% in Canada; 38.6% in China; 35.8% in Chile; 31.6% in Mexico; 28.6% in Australia; and 25.6% in the United States (Figure 1). Among the pesticides with commercialization data available in Brazil, the percentage of non-authorizations was: 77% in Norway; 75% in Iceland; 44% in Switzerland; 38% in Turkey; and 35% in the European Community.

International authorization of the most commercialized pesticide active substances in Brazil and association with chronic health and environmental effects

In terms of total commercialization volumes of pesticide active substances in Brazil, 539,944.95 tons were sold in 2017. Of these, 9.7% were not specified for substances that do not have at least three companies with the registration to preserve commercial confidentiality.

Among the 79 pesticide active substances mentioned in the 2017 commercialization report, 14 had a decrease in sales in the aforementioned period. Considering the 20 pesticide active substances with the highest volume of commercialization, 18 accounted for an increase in the period, especially tetraconazole, which increased more than 22 times (Table 1).

Considering all pesticide active substances with commercialization data released by Ibama, about 67.2% of the volume traded in 2017 presents at least one criterion related to damage to human health and the environment, which is included in lists that identify effects on human health or wildlife, i.e., a list of potential carcinogens according to IARC (possible or probable carcinogen) or USEPA (recognized, possible and probable carcinogen), endocrine disruptors, and candidates for substitution in Europe (Box 1). In Table 1 we present data for the 20 pesticide active substances with the highest volume of commercialization, excluding mineral and vegetable oils, representing 75% of the total volume sold in 2017, in which 11% of them meet at least one criterion that shows potential chronic damage according to the consulted lists.

Still in relation to pesticide active substances with commercialization data, 54% are unauthorized in at least three OECD countries, and 34% are unauthorized in the European Community. As for the BRICS countries surveyed in this study, 15 pesticide active substances are unauthorized for use in India (clethodim, fluazinam, flumetralin, imazalil, imazaquin, lactofen, mesotrione, MSMA, nicosulfuron, picloram, procymidone, simazine, sulfluramid, tebuthiuron, and triclopyr-butotyl) and 5 pesticide active substances cannot be used in China (cyproconazole, flumetralin, MSMA, sulfentrazone, and tebuthiuron). Among the 20 most traded pesticide active substances, 11 (55%) are unauthorized in at least three OECD countries and 5 (25%), in the European Community (Table 2).

Among pesticides active substances without authorization in at least three OECD countries and/or in the European Community, the total traded volume was 129,727.67 tons, corresponding to 24% of the total pesticide active substances sold in 2017. In Brazil, 16.4% of the total sales volume correspond to products unauthorized in the European Community (Tables 1 and 2).

Criteria for non-authorization of pesticide active substances in the European Community

In Box 2 we present data concerning effects on health and the environment for 19 out of 27 pesticide active substances with commercialization data in Brazil and unauthorized in the European Community. We did not include in the Box 2: 4 pesticide active substances without information (chlorimuron-ethyl, sulfentrazone, sulfluramid, and triclopyr-butotyl); 2 pesticide active substances (diafenthiuron and MSMA) were banned according to Regulation n. 2,076/2002 of the European Community for not complying with the current regulations (Directive n. 91/414), including the need for proving the absence of less harmful alternatives or the need for further studies; and for 2 pesticide active substances (imazetapir and novaluron), other regulations on the approval of specific pesticide active substances were mentioned. It is worth mentioning sulfluramid, whose degradation products are perfluorooctane sulfonate (PFOS), included in Annex B (restriction) of the Stockholm Convention ¹³13. Convention Stockholm. All POPs listed in the Stockholm Convention. http://www.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx (acessado em 12/Jun/2020).
http://www.pops.int/TheConvention/ThePOP... .

The completion reports of the European Community registration assessment processes of 11 active substances mentioned harmful effects on humans and the environment. 15 active substances were associated with critical toxic effects, according to European Directive n. 1,272/2008, which implemented the Globally Harmonized System (GHS) criteria. We also observed that 12 pesticide active substances had indications of damage to human health or the environment in the consulted lists of chronic effects (USEPA, IARC, candidate for substitution Europe, and potentially endocrine disruptors).

Discussion

The present study shows, in an unprecedented way, that approximately 80% of pesticides authorized for use in Brazil have no use permit in at least three OECD countries, including those that have an important economic activity in agriculture. In Australia, which has 40% of its territory under similar agricultural conditions, 114 pesticide active substances permitted in the Brazilian territory were not found in the records of this country. Although Brazil and India have relatively similar edaphoclimatic conditions, more than 50% of pesticides registered in Brazil do not have use permit in India. We also verified that the list of pesticide active substances authorized in Brazil includes examples with recognized toxicity on human health and the environment.

It is worth emphasizing that even for products authorized in Brazil and other countries, the conditions of use and preventive measures can be more rigid in these places, reducing the damage caused ¹⁴14. Bozzini E. Pesticide policy and politics in the European Union: regulatory assessment, implementation and enforcement. Cham: Palgrave Macmillan; 2017.^,1515. Paula AGO. O regime de regulação de riscos para o controle dos agrotóxicos no Brasil: comparação com os regimes da França e da Califórnia/EUA [Dissertação de Mestrado]. Brasília: Fundação Jorge Duprat Figueiredo de Segurança e Medicina do Trabalho; 2002.. Among them, we can mention the permitted use for few cultures and the restriction of use to trained workers such as the case of glyphosate in Europe ¹⁶16. European Parliament. Renewing the approval of the active substance glyphosate European. https://www.europarl.europa.eu/doceo/document/TA-8-2017-0395_EN.pdf (acessado em 11/Jun/2020).
https://www.europarl.europa.eu/doceo/doc... . In addition, measures that condition the safety of pesticide use in Brazil have not been effective for several reasons such as distances between properties and places of sale or disposal of packaging and access to information on use and potential damage ¹⁷17. Abreu PHB, Alonzo HGA. O agricultor familiar e o uso (in)seguro de agrotóxicos no município de Lavras/MG. Rev Bras Saúde Ocup 2016; 41:e18..

Brazilian agriculture, in addition to the use of large volumes of pesticides, extensively cultivates transgenic crops resistant to herbicides, such as glyphosate, 2,4-D, and dicamba, resulting in greater demand for the application of these substances and, consequently, in greater damage to ecosystems ¹⁸18. Almeida VES, Friedrich K, Tygel AF, Melgarejo L, Carneiro FF. Use of genetically modified crops and pesticides in Brazil: growing hazards. Ciênc Saúde Colet 2017; 22:3333-9..

Considering pesticide active substances with commercialization data in Brazil, for 41 of them, including the pesticides glyphosate, 2,4-D, acephate, and atrazine, there were already records of authorization for use in the country in 1985, through Ordinance n. 10 of the National Health Surveillance System, from the Brazilian Ministry of Health ¹⁹19. Ministério da Saúde. Portaria nº 10/SNVS, de 8 de março de 1985. Diário Oficial da União 1985; 14 mar.. Other 34 pesticide active substances, among the 79 listed in the 2017 commercialization report, were included in Resolution n. 165 of August 29, 2003 of Anvisa ²⁰20. Ministério da Saúde. Resolução DC/ANVISA nº 165, de 29 de agosto de 2003. Publica o "Índice das monografias dos ingredientes ativos de agrotóxicos, domissanitários e preservantes de madeira". Diário Oficial da União 2003; 2 set..

Still on the difference between Brazil and other analyzed countries and economic blocks, in the European Community, malathion had its use restricted to closed environments due to the serious acute and chronic effects on birds ²¹21. European Commission. Final review report for the active substance malathion finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 27 November 2009 in view of the inclusion of malathion in Annex I of Directive 91/414/EEC. https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=273 (acessado em 27/Jun/2020).
https://ec.europa.eu/food/plant/pesticid... , but it is widely used in Brazil for ultra-low volume dispersion (popularly known as fumigation) for vector control in public health initiatives. Aggravating this scenario, the application of pesticides, such as malathion, in densely populated areas by agricultural aircraft was authorized in Brazil according to Federal Law n. 13,301, of 2016 ²²22. Brasil. Lei nº 13.301, de 27 de junho de 2016. Dispõe sobre a adoção de medidas de vigilância em saúde quando verificada situação de iminente perigo à saúde pública pela presença do mosquito transmissor do vírus da dengue, do vírus chikungunya e do vírus da zika; e altera a Lei nº 6.437, de 20 de agosto de 1977. Diário Oficial da União 2016; 28 jun., even with experts’ warning about the inefficiency and insecurity of this method ²³23. Nota contra pulverização aérea de inseticidas para controle de vetores. Abrasco 2016; 29 abr. https://www.abrasco.org.br/site/noticias/saude-da-populacao/nota-contra-pulverizacao-aerea-de-inseticidas-para-controle-de-vetores-de-doencas/17430/ (acessado em 27/Jun/2020).
https://www.abrasco.org.br/site/noticias... .

The findings of the present study reiterate the losses resulting from increased contamination, evidenced in national surveys ⁶6. Carneiro FF, Rigotto RM, Augusto LGS, Friedrich K, Burigo AC. Dossiê Abrasco: um alerta sobre os impactos dos agrotóxicos na saúde. Rio de Janeiro: Escola Politécnica em Saúde Joaquim Venâncio, Fundação Oswaldo Cruz/São Paulo: Expressão Popular; 2015., including the presence of pesticides in food. Data from the Pesticide Residue Analysis in Food (PARA), of Anvisa, show that, among the 20 pesticide active substances most found in the surveyed foods, 7 (representing 40% of the total findings) are banned in at least three OECD countries. Mixtures of pesticides are also frequent, as 35% of the surveyed food samples contained from 2 to 21 residues ²⁴24. Agência Nacional de Vigilância Sanitária. Programa de Análise de Resíduos de Agrotóxicos em Alimentos. Relatório das amostras analisadas no período de 2017-2018. https://www.gov.br/anvisa/pt-br/assuntos/agrotoxicos/programa-de-analise-de-residuos-em-alimentos (acessado em 28/Jun/2020).
https://www.gov.br/anvisa/pt-br/assuntos... .

Recent studies show the contamination of rivers, soil, flora, and fauna with products extremely harmful to life and not permitted in other countries, such as endosulfan (banned in Brazil in 2013), cypermethrin, and ametryn ²⁵25. Pignati MT, Costa LS, Mendes RA, Lima MO, Pignati WA, Pezzuti CBJ. Levels of organochlorine pesticides in Amazon turtle (Podocnemis unifilis) in the Xingu River, Brazil. J Environ Sci Health B 2018; 53:810-6.^,2626. Guida YS, Meire RO, Torres JPM, Malm O. Air contamination by legacy and current-use pesticides in Brazilian mountains: an overview of national regulations by monitoring pollutant presence in pristine areas. Environ Pollut 2018; 242:19-30., the latter with potential toxicity to aquatic life (Box 2).

The existence of damage to the environment and evidence indicating serious and potentially irreversible effects on humans, such as endocrine disruption and carcinogenicity, should be sufficient for the adoption of precautionary measures, provided for in the Brazilian legislation. The importance of this study is reinforced by the recent approval of RDC n. 294 of July 29, 2019, which provides for the criteria for toxicological assessment and classification without indicating the mandatory toxicological studies for registration and reevaluation procedures ²⁷27. Ministério da Saúde; Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada nº 294, de 29 de julho de 2019. Dispõe sobre os critérios para avaliação e classificação toxicológica, priorização da análise e comparação da ação toxicológica de agrotóxicos, componentes, afins e preservativos de madeira, e dá outras providências. Diário Oficial da União 2019; 31 jul..

In Brazil, pressure from economic sectors on legislators seeks to make Law n. 7,802/1989 more flexible, which regulates the registration, evaluation, and use of pesticides in the country. Among the proposed changes is the removal of the registration prohibition criteria for potentially carcinogenic agents, toxic to the reproductive system, endocrine disruptors, and teratogens, which are currently similar to the criteria adopted in Europe. With the changes, the use of substances associated with these effects may be permitted through risk assessment. In Europe there is also pressure on this prospect, but studies have shown that the supposed economic losses would not be higher than health costs, loss of individual quality of life, deaths, reduced productivity due to absenteeism, among others ²⁸28. Policy Department Economic and Scientific Policy, European Parliament. The benefits of strict cut-off criteria on human health in relation to the proposal for a Regulation concerning plant protection products. https://www.europarl.europa.eu/RegData/etudes/etudes/join/2008/408559/IPOL-JOIN_ET(2008)408559_EN.pdf (acessado em 03/Jul/2020).
https://www.europarl.europa.eu/RegData/e... .

In addition to other effects, endocrine disruption has a ban indication in the European Community ²⁹29. União Europeia. Regulamento (CE) nº 1.107/2009 do Parlamento Europeu e do Conselho de 21 de Outubro de 2009 relativo à colocação dos produtos fitofarmacêuticos no mercado e que revoga as Diretivas 79/117/CEE e 91/414/CEE do Conselho. Jornal Oficial da União Europeia 2009; 24 nov.. However, the implementation of this measure encounters resistance to be fully effective, due to controversies and doubts raised by economic sectors to define the necessary criteria for this classification, common strategies regarding the regulation, and use of toxic substances ³⁰30. Michaels D. Doubt is their product: how industry's assault on science threatens your health. New York: Oxford University Press; 2008..

The European legislation also provides for the definition of pesticide candidates for substitution, which may have their use authorization canceled ¹⁰10. Directorate General for Health and Consumers, European Commission. Ad-hoc study to support the initial establishment of the list of candidates for substitution as required in Article 80 (7) of Regulation (EC) n 1107/2009. Final report. https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_cfs_report-201307.pdf (acessado em 11/Jun/2020).
https://ec.europa.eu/food/sites/food/fil... . For inclusion in the list, the pesticide active substances must meet at least one of the following criteria: (a) values of acceptable daily intake (ADI), acute reference dose (ARfD), or Acceptable Operator Exposure Level (AOEL) lower than most substances approved in the same category; (b) to meet two criteria, including persistence, bioaccumulation, or toxicity; (c) association with effects considered critical (for example, neurotoxicity or immunotoxicity) in contexts where exposure control measures are not effective, such as the potential for groundwater contamination, the use of personal protective equipment (PPE), or long distances from application; (d) a significant proportion of non-active isomers; (e) classification as a carcinogen, toxic to the reproductive system or endocrine disruptor, but which has not been banned for reasons established in regulations. This list, composed of 77 pesticide active substances, contains 52 pesticides authorized in Brazil, including carbendazim, epoxiconazole, chlorpyrifos, and linuron which, together with thiophanate methyl, procymidone and chlorothalonil, are scheduled be reassessed by Anvisa based on RDC n. 221/2018³¹31. Agência Nacional de Vigilância Sanitária; Ministério da Saúde. Nova metodologia define reavaliação de agrotóxicos. http://antigo.anvisa.gov.br/resultado-de-busca?p_p_id=101&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&p_p_col_id=column-1&p_p_col_count=1&_101_struts_action=%2Fasset_publisher%2Fview_content&_101_assetEntryId=5610165&_101_type=content&_101_groupId=219201&_101_urlTitle=nova-metodologia-define-reavaliacao-de-agrotoxicos&inheritRedirect=true (acessado em 03/Jul/2020).
http://antigo.anvisa.gov.br/resultado-de... .

In 2002, in Brazil, the registration review for 18 pesticide active substances started due to effects on human health. The following pesticide active substances monocrotophos, pentachlorophenol, and lindane were banned in 2006; cyhexatin, in 2009; endosulfan and trichlorfon, in 2010; methamidophos, in 2011; methyl parathion and phorate, in 2015; prochloraz, in 2016; and carbofuran, in 2017. Prochloraz is authorized in 77% of the studied countries; phorate, in 31%; carbofuran, endosulfan and pentachlorophenol, in 23%; monocrotophos and cyhexatin, in 15%; metamidophos and methyl parathion, in 8%; and lindane, in none of them. This finding demonstrates that these bans imposed by Brazil are in line with other countries.

Paraquat, in 2017, was indicated for ban, but it had use permit in the country until September 22, 2020. The records of acephate, phosmet, lactofen, and 2,4-D were kept, and until May 2020 the processes of toxicological reevaluation of glyphosate and abamectin were inconclusive. For comparison purposes, China banned 50 pesticides in 2014 alone, started the banning process of another 30 pesticides, and announced the ban of another 12 pesticide active substances in 2022 ¹²12. Food and Agriculture Organization of the United Nations. Progress in pesticide risk assessment and phasing-out of highly hazardous pesticides in Asia (2015). http://www.fao.org/3/a-i4362e.pdf (acessado em 12/Jun/2020).
http://www.fao.org/3/a-i4362e.pdf... .

For reevaluations that had not been concluded six years after they started, a deadline for finalization was judicially determined by a Public Civil Suit of the Federal Attorney General’s Office (ACP n. 21371-49.2014.4.01.3400 - 7th Federal Court-District Federal, Brazil), considering the possibility of effects on exposed populations. In the case of thiram and lactofen, whose reevaluations started in 2008, the technical opinion of Anvisa indicated the maintenance of the record, even without the assessment of important aspects of its toxicity: “due to the short time granted by the courts, it was not possible to analyze all available studies” ³²32. Agência Nacional de Vigilância Sanitária. Parecer Técnico de Reavaliação nº 05, de 2015/GGTOX/ANVISA. Parecer Técnico de Reavaliação nº 06, de 2015/GGTOX/ANVISA. Reavalia o ingrediente ativo Tiram em relação à mutagenicidade, toxicidade reprodutiva, desregulação endócrina e neurotoxidade. http://antigo.anvisa.gov.br/documents/10181/2858811/Anexo+1+-+Parecer+5+de+2015+-+Muta_tox_reprodutiva__desr_endocrina_neurotoxicidade.pdf/57d073df-9007-4820-8fec-2424943c78d7 (acessado em 03/Jul/2020).
http://antigo.anvisa.gov.br/documents/10... (p. 29). In both thiram and lactofen reevaluation opinions, studies on toxicokinetics (metabolism) and acute, subchronic, and chronic toxicity have not been presented, although they are crucial for the assessment of danger, risk, and the calculation of safety limits such as ARfD and ADI ³³33. Agência Nacional de Vigilância Sanitária. Reavalia o ingrediente ativo Lactofem com relação aos aspectos de mutagenicidade, carcinogenicidade e efeitos reprodutivos. http://antigo.anvisa.gov.br/documents/33880/2541537/Parecer%2BT%25C3%25A9cnico%2Bde%2BReavalia%25C3%25A7%25C3%25A3o%2BLactofem%2B-%2BCP.pdf/98f129e9-af25-4fbd-94c3-98694a56ece5 (acessado em 03/Jul/2020).
http://antigo.anvisa.gov.br/documents/33... . In this study, we observed that thiram is listed as unauthorized in Japan, Norway, and Iceland, whereas lactofen is unauthorized in almost all surveyed countries, except the United States and China.

Acephate and 2,4-D, which underwent toxicological reevaluation in Brazil, but had their records maintained, are unauthorized in several countries, as shown in Table 2. The remaining reevaluated products maintained or with a still unfinished process have no use permit in the following countries: (i) phosmet - India, Japan, New Zealand, Switzerland, Norway, and Iceland; (ii) lactofen - Australia, Canada, Chile, India, Israel, Japan, Mexico, New Zealand, Switzerland, Turkey, European Community, Norway, and Iceland; (iii) 2,4-D - Norway and Iceland; and (iv) thiram - Japan, Norway and Iceland. During the course of this study, thiram was indicated for ban by the European Community due to acute effects on workers and consumers, damage to birds and mammals, incomplete information for one of the metabolites, and formation of N,N-dimethylnitrous amide (NDMA) in drinking water ³⁴34. European Commission. Non-legislative Acts. Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018, concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram. Official Journal of the European Union 2018; (254)..

In 2012, Ibama indicated the suspension of dispersion by aircraft of four insecticides due to damage to bees: imidacloprid, thiamethoxam, clothianidin, and fipronil. This decision was immediately suspended due to economic reasons ³⁵35. Ministério da Agricultura Pecuária e Abastecimento. Ato nº 1, de 2 de outubro de 2012. Dispõe sobre a aplicação aérea dos ingredientes ativos imidacloprido, clotianidina, fipronil e tiametoxam. Diário Oficial da União 2012; 3 out.. The European regulatory body banned fipronil in 2010, adopted severe restrictions in 2013 for imidacloprid, thiamethoxam, and clothianidin ³⁶36. European Commission. Bee health: EU takes additional measures on pesticides to better protect Europe's bees. Brussels: European Commission; 2013. and, in May 2018, announced a ban on the use of these three active substances in open areas due to damage to bees ³⁷37. European Commission. Neonicotinoids. https://ec.europa.eu/food/plant/pesticides/approval_active_substances/approval_renewal/neonicotinoids_en (acessado em 03/Jul/2020).
https://ec.europa.eu/food/plant/pesticid... .

The reduction of impacts of pesticides on human health and the environment is indicated in Europe through measures, such as those of Directive n. 128/2009³⁸38. European Parliament. Directive 2009/128/EC of the European Parliament and the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. Official Journal of the European Union 2009; (309)., aimed at promoting integrated pest management and the adoption of methods without using chemical substances, in addition to other sustainable approaches. Guidelines from organizations, such as FAO, Pan American Health Organization (PAHO), and WHO, also provide guidance on the importance in promoting other models of agriculture, whether by reducing the use of pesticides or even transitioning to organic and agroecological production modes ³⁹39. Committee on World Food Security. High level panel of experts. Report on agroecological and other innovative approaches for sustainable agriculture and food systems than enhance food security and nutrition. Rome: Food and Agriculture Organization of the United Nations; 2019.. In Brazil, governmental initiatives, such as the National Policy on Agroecology and Organic Production, instituted by Decree n. 7,794 of August 2012, encouraged the elaboration of a National Program for the Reduction of Pesticides, which was never implemented ⁴⁰40. Comissão Nacional de Agroecologia e Produção Orgânica. Proposta do Programa Nacional de Redução de Agrotóxicos. https://www.icict.fiocruz.br/sites/www.icict.fiocruz.br/files/pronara-programa-nacional-de-reducao-de-agrotoxicos-aprovado-por-merito-na-cnapo-em-agosto-de-2014.pdf (acessado em 03/Jul/2020).
https://www.icict.fiocruz.br/sites/www.i... , but goes through legislative proceedings in the National Congress, via Bill n. 6,670/2016 that intends to institute it as a public policy.

One of the study limitations was the difficulty in comparing the volumes of pesticide active substances commercialized in Brazil and in Europe, considering that in the researched databased data are presented by groups, according to indication of use and chemical group ⁴¹41. Eurostat. Pesticide sales statistics. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Archive:Pesticide_sales_statistics (acessado em 03/Jul/2020).
https://ec.europa.eu/eurostat/statistics... . Another noteworthy issue was the difficulty in accessing information related to the authorization of pesticides on the official databases of the United States and China. Therefore, information about registration in the United States should be considered with reservations. Information on registration in China was obtained from a FAO document published in 2015 and may have been updated in that period. Moreover, we could not identify the reasons for the non-authorization of pesticide active substances, which overall are not presented in a clear and systematic way by the regulatory agencies.

Hence, the classifications of these pesticides for serious chronic effects have also been researched on official databases. The list of authorized monographs of Anvisa included pesticide active substances for agricultural use with the potential for serious damage, included in the list of candidates for substitution, endocrine disruptors, and probable or possible carcinogens, effects which are indicative of ban under the current legislation. It should be noted, however, that the ban of a pesticide active substances in Brazil can also occur due to other effects that were not investigated in this study (such as teratogenesis and reproductive toxicity), but also others that are equally serious (neurotoxicity, immunotoxicity, etc.) depending on the dose-effect relationship applied to the intended use. Deepening the investigation, including other toxic effects, may increase the number of authorized pesticides in Brazil with the potential for serious damage to health.

Three central issues stand out from this study. First, Brazil, a large global consumer market for pesticides, uses products that are not permitted in other countries, almost all of which have been available in the national market for more than four decades, which may not attract the attention of industries that may choose to launch more modern products in locations that review environmental, health, and agronomic issues more frequently.

Second, the need for adopting more protective criteria with regard to the registration of pesticides in the country. In this sense, the study is relevant in highlighting the importance of reviewing the registration of unauthorized products in at least three OECD member countries or in the European Community. In cases where the non-authorization of use has occurred due to damage to the environment or human health, the registration should be immediately canceled in Brazil.

Finally, the study points to the need for greater transparency by international regulatory agencies regarding the reasons for authorizing or not the pesticide active substances, in order to subsidize protection actions and encourage the global market to develop less harmful and more sustainable technologies. Greater transparency is essential to support actions to protect biodiversity and human populations, especially the most vulnerable ones such as traditional communities and peoples in periphery countries. In addition, it would also promote the development of less harmful technologies and sustainable agricultural production methods, such as Agroecology, considered by FAO ³⁹39. Committee on World Food Security. High level panel of experts. Report on agroecological and other innovative approaches for sustainable agriculture and food systems than enhance food security and nutrition. Rome: Food and Agriculture Organization of the United Nations; 2019. as a way to achieve the Sustainable Development Goals of the 2030 Agenda.

Acknowledgments

We would like to thank the Brazilian National Cancer Institute José Alencar Gomes da Silva (INCA) for providing the translation of the English version.

References

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