Chemical name: O,O-Dimethyl O-4-nitrophenyl phosphorothioate

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: All uses.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action: Prohibition of all technical and formulated products based on Methyl Parathion active ingredient. So, the production, use, trade, import and export of Methyl Parathion had been banned.

The reasons for the final regulatory action were relevant to: Human health

Summary of known hazards and risks to human health:

In 2008, the Brazilian Health Regulatory Agency (Anvisa) initiated the toxicological reassessment of Methyl Parathion due to evidences of high acute toxicity, neurotoxicity, endocrine disruption, mutagenicity and carcinogenicity of this active ingredient of pesticides.

Brazilian law predicts that pesticides may have their registrations cancelled in the country when they fall under the following conditions related to human health: when they have no antidote or effective treatment in Brazil; if found teratogenic, mutagenic or carcinogenic; if they cause hormonal disturbances and damage to the reproductive system or if they are more dangerous to humans than demonstrated in tests with laboratory animals.

Methyl Parathion is classified by the World Health Organization as extremely neurotoxic, causing behavioral changes, respiratory depression, respiratory paralysis, coma, death, intermediate syndrome and delayed polyneuropathy (WHO, 1992).

Considering the technical note of Fiocruz, the contributions from the registrant in the public consultation, the international regulatory situation and the scientific literature, Anvisa concluded Methyl Parathion is extremely neurotoxic, with evidence of compromising neurobehavioral development, proving to be more dangerous to man than laboratory tests on animals have been able to demonstrate (Crowder et al., 1980; Gupta et al., 1985; Kumar e Devi, 1992; Kumar and Devi, 1996; Ruckart et al., 2004; Slotkin et al., 2008; Eells e Brown, 2009; Johnson et al., 2009; Slotkin et al., 2009; Levin et al., 2010; Adigun et al., 2010a; Adigun et al., 2010b; Lassiter et al., 2010). Potential mutagenesis (Mahli and Grover, 1987; Mathew et al., 1990; Vijayaraghava and Nagarajan, 1994; Nehez et al., 1994) and reproductive toxicity (Ogi e Hamada, 1965; Bell et al., 2001; Kumar, 2004; Woodruff et al., 2008; Yucra et al., 2008) were also confirmed.

In addition to the hazard assessment, the characterization of the exposure in Brazil shows potential risks to the population. According to data from the Brazilian Program on Pesticide Residue Analysis in Food, between 2009 and 2013 Methyl Parathion residues were observed in unauthorized cultures (kale, apple, orange, and strawberry) or above the maximum allowed limits.

Therefore, from the revaluation of the health effects of Methyl Parathion, completed in 2015, ANVISA concluded this active ingredient of pesticides is mutagenic, causes damage to the reproductive system and is more toxic to humans than demonstrated in tests with laboratory animals, which are prohibitive criteria for registration of pesticides in Brazil. Therefore, Methyl Parathion was completely banned in Brazil in 2016.

Expected effect of the final regulatory action in relation to human health: Eliminate health risks posed by Methyl Parathion.

Date of entry into force of the final regulatory action: 14/12/2015