Chemical name: Phosphorothioic acid, O,O-dimethyl O-(3-methyl-4-nitrophenyl) ester 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 the applications as a plant protection product. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing fenitrothion. Fenitrothion is not included in the list of authorised active ingredients in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing fenitrothion had to be withdrawn by 25 November 2007. From 2 June 2007 no authorizations for plant protection products containing fenitrothion can be granted or renewed. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Operators and Workers Exposure of operators and workers is unacceptable in most outdoor scenarios. For dermal exposure (using dermal absorption values of 3.9% for the concentrate and 20.9% for the dilution), the estimated operator exposure in the outdoor treatment of grapes (using both the German and UK POEM models) exceeds the AOEL by at least 238% using the German model (and greater using UK POEM). This exceedance is also true for re-entry exposure estimates for workers not wearing PPE. For outdoor use on tomatoes, the estimated operator exposure is below the AOEL only for field crop spraying with the use of PPE; re-entry estimates for workers not wearing PPE exceed the AOEL. Exposure estimates for general re-entry activities exceed the AOEL for workers not wearing PPE. Consumers Acute and chronic risk assessments have been carried out taking into account fenitrothion residues only. Using International (National) Estimated Daily Intakes to estimate the actual exposure to residues in tomatoes, table and wine grapes, it was concluded that chronic exposure was well below the Acceptable Daily Intake (ADI). However, assessing acute exposure to residues of fenitrothion according to the WHO model for estimates of short-term intakes, and using large portion consumption data for UK adults and children, exposure was in excess of the Acute Reference Dose (ARfD; 300% and 1300% for adults and children, respectively) for table grapes. These assessments demonstrated a potential acute risk from the consumption of table grapes. Expected effect of the final regulatory action in relation to human health: Reduction of risk to operators, workers and consumers from the use of plant protection products. Summary of known hazards and risks to the environment: Environmental risk evaluations were carried out by estimation of potential outdoor exposure for the use of fenitrothion on tomato and grapevine, and comparison with the most sensitive acute and chronic ecotoxicological endpoints for different organisms in the environment. If the resultant Toxicity/Exposure Ratio (TER) was below the Annex VI Trigger value then exposure of fenitrothion was considered to be an unacceptable risk to that organism. Using this evaluation, the acute, short-term risk to birds and the long-term risk to mammals from uptake of contaminated food items were assessed as high from the representative outdoor uses (tomato and grapevine). A high long-term risk to birds and mammals was identified from the uptake of contaminated earthworms. The risk to earthworms from chronic exposure to fenitrothion was also assessed as high. Daphnia magna was the most sensitive tested aquatic species. Predicted environmental concentrations (PECs) were derived from spray drift applications for outdoor use and compared with the most sensitive ecotoxicity endpoints. The resulting TERs were well below the relevant Annex VI Trigger values indicating high acute and chronic risks from representative outdoor uses. A high risk to aquatic organisms from greenhouse use cannot be excluded in the event of exposure. The environmental risk of exposure of bees to fenitrothion was carried out by comparison of the potential exposure from use on tomatoes with the experimental oral and contact toxicity to give a Hazard Quotient (HQ) with a value above the Annex VI Trigger value indicating a potential risk to bees. A high risk to bees was shown from oral and contact exposure to fenitrothion (technical) and for contact toxicity of the formulation IPM 400 CS and a high risk from outdoor uses cannot be excluded. Expected effect of the final regulatory action in relation to the environment: Reduction of risk to the environment (e.g. birds, mammals, aquatic organisms, bees and earthworms) from the use of plant protection products. Date of entry into force of the final regulatory action: 25/11/2010 Complete entry into force of all provisions of Commission Decision 2007/379/EC of 25 May 2007 was 25 November 2008 since all uses of plant protection products containing fenitrothion were prohibited as from that date at the latest. |