Chemical name: 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: At the end of the phase-out described below, all formulations containing endosulfan and all uses of theses formulations will be prohibited: 1) 31 July 2010 to 31 July 2011 - production, formulation and imports of technical and formulated product can not exceed 14 million litres of formulated product in total; 2) 31 July 201 1 to 31 July 2012 - production, formulation and imports of technical and formulated product can not exceed 8 million litres of formulated product in total; 3) 31 July 2011 - imports of technical and formulated endosulfan products forbidden, only the national production remain allowed; 4) 31 July 2012 - production of all technical and formulated endosulfan products forbidden in Brazil; 5) 31 July 2013 - trade of all formulated products based on endosulfan forbidden, and toxicological evaluation reports of technical and formulated products with the active ingredient endosulfan cancelled; 6) 31 July 2014 - monograph of the active ingredient cancelled, the monograph will be maintained until this date solely for purposes of wastes monitoring. 7) From 16 August 2010 (date of the publication of the decision): - The use of endosulfan was banned in crops of cocoa, keeping only the crops of soybean, coffee, sugar cane and cotton. - The aerial application and manual/cage application for all crops was banned. - The use to control ants was banned. - The use as wood preservative was banned. Pesticide use or uses that remain allowed: None. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: The Committee on Pesticide Reassessment, composed by the National Health Surveillance Agency (ANVISA), the Ministry of Agriculture, Livestock and Food Supply (MAPA), and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA), determined the scheduled withdrawal of the endosulfan active ingredient from the Brazilian market within three years, counted from July 31, 2010. The National Health Surveillance Agency (ANVISA) published resolution, based on the Recommendation of the Committee establishing measures and gradual deadlines over these three next years, culminating with the banning of the substance. After this Resolution, the Ministry of Agriculture, Livestock and Food Supply published Act, cancelling the registers of some products based on endosulfan and of the new registering processes. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Endosulfan, its isomers and metabolites cause serious negative effects on human health and environment, especially for the neurological, reproductive, endocrine and immune human systems, according to scientific evidences. Subchronic and chronic studies suggest that the liver, kidneys and immune system are the main target organs. Populations which are notoriously susceptible to endosulfan are the unborn, newborns, children (mainly male, as the endosulfan has estrogenic properties and endocrine desegulation) and also the elderly and people with liver-leaf, kidney, immunological, haematological, or neurological impairments. Exposure to endosulfan has been linked to congenital physical disorders, mental retardations and deaths. The exposure of children may differ from adults since the physiology and unique child behaviours may influence the extent of exposure. Children are particularly sensitive to endosulfan due to the high intestinal permeability and immature detoxification system. The population with potentially high exposure to endosulfan or endosulfan sulfate includes people living near contaminated sites with these compounds. Agricultural work is one of the most dangerous occupations nowadays. The agricultural workers are susceptible to serious occupational risks due the exposure to pesticides, for example, acute poisoning, chronic diseases and reproductive problems. In the occupational setting, the exposure to endosulfan occurs predominantly via inhalation or ingestion. The workers may be exposed during mixing, loading or applying the compound, in cases of lack of protective equipment. Endosulfan is easily absorbed when in contact with the skin. Reference: Technical Note of the Toxicological Reassessment on Endosulfan - ANVISA (National Health Surveillance Agency)/Brazil Link: http://portal.anvisa.gov.br/wps/wcm/connect/39683b804745869d8fecdf3fbc4c6735/Nota+t%C3%A9cnica+final+do+endossulfam%2C+ap%C3%B3s+a+Consulta+P%C3%BAblica.pdf?MOD=AJPERES Expected effect of the final regulatory action in relation to human health: Do not use, trade nor import the product. Summary of known hazards and risks to the environment: Endosulfan is highly toxic for humans and for most animal groups, showing both acute and chronic effects at relatively low exposure levels. Endosulfan sulfate, the main metabolite of endosulfan. shows an acute toxicity, accumulating in fatty tissues of animals. It is the main residue found in animal tissue after exposure. Recent studies indicate that endosulfan has the potential to cause endocrine disruption both in terrestrial and aquatic species. The main adverse effects shown on terrestrial organisms are disturbs on growth of amphibians, reduced cortisol secretion in fishes, hormonal disturbs levels in birds, testicular atrophy and reduced sperm production in mammals. For these reasons, endosulfan was included in the list OSPAR (International Cooperation on Protection of the Marine Environment of the North) of potential endocrine disrupters (GERMAN FEDERAL ENVIRONMENT AGENCY, 2007). Marine animals also accumulate considerable amounts of this substance. The toxicity of endosulfan generally increases when the temperature increases. Therefore the marine organisms are usually more sensitive to endosulfan than freshwater organisms. Endosulfan is toxic to fish in low amounts, causing 50% mortality of most species in 24 hours under laboratory conditions. Various studies have reported the acute toxicity of endosulfan to fish and aquatic invertebrates. Because they are extremely sensitive to the insecticide, the death of fish has been reported on several occasions as a result of entrainment of endosulfan to rivers. Applying endosulfan in flooded areas, even at recommended levels, may also result in fish mortality. Among the effects in animals there are reproductive problems and declining population; abnormal functioning of thyroid and other hormonal disorders; feminization of males and masculinization of females; compromised immune system, tumours and cancers; behavioural abnormalities and increased incidence of foetal malformation (teratogenesis). On November 2008, Paraiba do Sul River (Rio de Janeiro) has been affected by the spill of 8000 litres of endosulfan, from the company Solvay. The extent of contamination caused by that leakage covered more than 400 km along the river, leading, throughout its length, huge mortality of various fish species. This disaster brought enormous consequences for ecosystems and coastal populations, and economic losses. References : - Technical Note of the Toxicological Reassessment on Endosulfan - ANVISA (National Health Surveillance Agency) / Brazil: http://portal.anvisa.gov.br/wps/wcm/connect/39683b804745869d8fecdf3fbc4c6735/Nota+t%C3%A9cnica+final+do+endossulfam%2C+ap%C3%B3s+a+Consulta+P%C3%BAblica.pdf?MOD=AJPERES - IBAMA Technical Staff Expected effect of the final regulatory action in relation to the environment: Do not use, trade nor import the product. Date of entry into force of the final regulatory action: 31/07/2010 |