Chemical name: Benzene, 2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-(trifluoromethyl)- 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: Ban all formulation and for all uses. 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: Based on the decision N. 001/DNSA/2014 oxyfluorfen was banned by the National Directorate of Agrarian Services from further import and use in Mozambique. The ban of all uses and the cancellation of the products containing the oxyfluorfen in the country was decided due to the toxic nature and hazardous properties of this active substance, which combined with the local conditions of use can damage human and animal health and additionally cause potential damage to the environment The decision to cancel the registration of oxyfluorfen was taken as the last step of the project for Risk Reduction of Highly Hazardous Pesticides, which identified Highly Hazardous Pesticides that are registered in Mozambique. After consultations with different actors (public sector, private sector, civil society and others), cancelation of registrations and consequent non-approval for their use in Mozambique was approved. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: A project entitled Reducing Risks of Highly Hazardous Pesticides (HHPs) in Mozambique was initiated by the Government of Mozambique with the objective to reduce the risks associated with pesticide use in the country. The ultimate goal was to develop and implement an "HHP Risk Reduction Action Plan" for the most dangerous pesticides and use situations, resulting over time in the implementation of a variety of risk reduction measures based on a review of use conditions. In the first step of the project, a review of all pesticides registered in Mozambique was carried out and a shortlist of highly hazardous pesticides was identified. This shortlist was based on an assessment of the hazards of the pesticides, based on criteria established by the FAO/WHO Joint Meeting on Pesticide Management (JMPM) (FAO/WHO, 2008). Based on the hazard assessment in Step 1, a short list of HHPs, including "coming close" to HHPs, which were used in the country, was established. Oxyfluorfen was on the short list as a pesticide "coming close" to HHPs based on the below indicated criteria: -Pesticides for which carcinogenicity evaluations by different registration/assessment authorities did not lead to consistent classification as GHS Category 1A or 1B, but which were, based on the evidence of one of these authorities, considered of particular concern for use in Mozambique (Come A.M.& van der Valk H., 2014). -Oxyfluorfen was classified by the US EPA as YES/likely to be carcinogenic (2010). It was registered in the US. Due to the cancer risk of handlers' applicators/workers, double layer of Personal Protective Equipment (PPE) for all other mixers, loaders, and applicators was required. In addition, closed mixing/loading/ application systems were required for use in several major crops. Oxyfluorfen was registered in the EU. The EFSA conclusion from 2010, proposed oxyfluorfen in Category 3 of carcinogenicity classification with limited evidence of carcinogenic effect. The US proposed risk mitigation measures (double PPE and closed systems) posed significant concern for Mozambican use situation. The final conclusion for the HHP assessment in Mozambique identified oxyfluorfen as carcinogenic equivalent or similar to GHS Class 1A&1B, and therefore considered as "coming close" to HHPs. (Come A.M.& van der Valk H., 2014.) During the second step of the project, a pesticide use field surveys and exposure were carried out in selected regions and cropping systems in Mozambique. The main goal of the survey was to identify the conditions under which pesticides are being used in the country and their contribution to potential risks for human health and the environment. The surveys (325 subsistence farmers interviewed) revealed that most of the farmers applied pesticides (95%), and that the conditions of use were likely to result in undue (excessive) exposure. Half of the farmers interviewed never received any training on pesticides use, and even the other half that did, often lacked understanding of the risks involved. Farmers were spraying vegetable crops at least 14 times per growing season. One out of three applications was involving one of the HHP containing formulation (Farmers using HHPs includes almost 30% of the interviewed farmers). Also almost none of the farmers (93%) owned or wore adequate PPE having only one or no protective items at all. Only 2% of those applying HHPs wore adequate full body protection PPE. About half of the farmers had not received any training on the use of pesticides. The majority of pesticide applicators used manual sprayer (36%), followed by electric sprayer (with batteries); 33% and followed by inappropriate equipment such as watering can (13.5%) or other (unknown) means (12.5%). Approximately about half of the farmers surveyed reported that they noticed to receive pesticide on their clothes, bare skin or eyes when using pesticides. The main health symptoms associated with pesticide use by farmers noticing symptoms were headaches, skin rashes, burning eyes, vomiting, burning nose, blurred vision, dizziness and excessive sweating. Almost half of the farmers declared they did not read pesticide labels, including use instructions such as proper dosage and protective measures, the main reason being illiteracy. One out of four farmers poorly understood the hazard colour band on pesticide labels that indicates acute toxicity. The survey results showed that the use of pesticides in general, and of HHPs in particular, was likely to result in excessive exposure of farmers in Mozambique. Therefore enforcing risk mitigation measures depending solely on wearing the appropriate PPE under the local conditions of use to be difficult and unlikely to give results. The third step of the project consisted of a stakeholder consultation to further discuss the use and risks of highly hazardous pesticides in Mozambique and fine-tune the shortlist based on the survey results and the expertise and experience of stakeholders. During the fourth step of the project, the risk of occupational exposure was assessed for a subset of the shortlisted pesticides, including oxyfluorfen. The subset included nine pesticides in seven different cropping systems using 13 application scenarios, each with and without personal protective equipment (PPE). For the occupational risk assessment an estimate of operator exposure was made, which was then compared to a toxicologically acceptable level. The exposure assessment used the registered dose rates and other application parameters for each pesticide based on farming conditions in Mozambique, including application with backpack sprayers (used in vegetables, tobacco, cereals and several other crops), hand-held rotary atomisers (used in cotton), and tractor- mounted sprayers. The exposure of pesticide applicators wearing full PPE that is realistically available in Mozambique was compared to the exposure of applicators wearing shorts and a T-shirt, as is often the case for smallholder farmers. The toxicologically acceptable level of exposure applied in this study was the Acceptable Operator Exposure Level (AOEL), which is defined as the maximum amount of active substance to which the operator may be exposed without any adverse health effects (EC, 2006). The cropping systems that were evaluated are those for which the pesticide were registered. In some cases, crops were grouped together when the exposure to the pesticide were likely to be similar, based on height of the crop and the application method. The volume application rates used in the model were generally those recommended on the label of the registered pesticide in Mozambique. If a volume application rate was not indicated on the label, 200 litres of pesticide mixture per ha was used as a default for EC or SC formulations applied with hydraulic nozzles or by air-assisted sprayers (high volume application). In the case of cotton applications, a scenario where 10 litres of mixture per ha was applied using rotary atomisers (low volume application) was also evaluated. The dose rates used in the models were the highest rates recommended on the labels of the registered pesticide. In some cases where a wide range of dose rates was recommended, the lowest dose rate was also evaluated. The risk of occupational exposure to pesticides was assessed, in particular when spraying the products. The risk of worker exposure (e.g. during harvesting) or bystander exposure was not evaluated. For the occupational risk assessment an estimate of operator exposure was made, which was then compared to a toxicologically acceptable level. Exposure of pesticide applicators was estimated using occupational exposure models that are often applied in the European Union: the so-called "German model" and the "UK Predictive Operator Exposure Model" (UK-POEM) (Hamey et al. 2008; EFSA 2010). The models are different in their exposure calculations and also include different exposure scenarios. Therefore, both models are often used in parallel in the EU when assessing occupational exposure. Exposure scenarios and application parameters for the models were based on Mozambican pesticides application conditions. Table 1. Details on the pesticides and cropping systems used in the operator risk assessments PesticideConcentration & type of formulation 1Cropping systemsVolume application rate (L mixture/ha)Dose rate (L or kg formulation/haAOEL 2, 3 (mg a.i./kg bw/day) Oxyfluorfen240 g a.i./L ECVegetables, soybean35030.013 APine & eucalyptus trees, citrusCotton 1 a.i. = active ingredient; WP = wettable powder; SL = soluble concentrate; WG -= wettable granules 2 bw = bodyweight 3 Sources of AOELs: A = FootPrint - Pesticide Properties Database (undated); B = Rotterdam Convention (2011); C = ERMA (2010)- Expression of risk The risk for the pesticide operator has been expressed as a risk quotient, which is the ratio between the estimated exposure of the operator to the pesticide (in mg a.i./kg bw/day) and the AOEL (in mg a.i./kg bw/day). A risk quotient 1 implies that the risk is not acceptable; a risk quotient £ 1 implies an acceptable risk. For instance, a risk quotient of 100 means that the estimated exposure level of the operator, for the given pesticide application scenario, is a 100 times higher than the acceptable exposure level. - Outcome of the risk assessments The results of the pesticide operator risk assessments for oxyfluorfen are summarized in the table below. Risk quotients are given for the scenario when no PPE is worn during both mixing and spraying (worst case situation) and for the scenario with full PPE during both mixing and spraying (best practice situation). Table 2Outcome of the operator risk assessments for formulations containing Oxyfluorfen, a pesticide "coming close to a HHP". Pesticide formulationCropping systemApplication rateExposure modelUse of PPERisk quotient240 g/L ECVegetables, soybean720 g a.i./haUK - hand-held sprayer; low level targetMixing no; spraying no35Mixing yes; spraying yes5.6240 g/L ECCotton432 g a.i./haUK - hand-held sprayer; low level targetMixing no; spraying no33Mixing yes; spraying yes5.8240 g/L ECCitrus Pine trees Eucalyptus trees720 g a.i./haUK - hand-held sprayer; low level targetMixing no; spraying no30Table 2 shows the results for the application of the herbicide oxyfluorfen in vegetables, soybean, cotton and in citrus and forestry uses. In all cases was the AOEL exceeded, irrespective of the use of PPE. -Occupational risks The occupational risk assessments showed that the applications of six pesticides (among those oxyfluorfen) at registered dose rates would result in exceedance of acceptable operator exposure levels in all cropping systems that were assessed, both with and without PPE. (Table 3). The exceedance of the AOEL when applying oxyfluorfen with PPE was relatively limited (RQ = 2.3 - 5.8). Possibly the strict enforcement of using full PPE combined with engineering control such as low-drift nozzles could reduce the occupational risk to acceptable levels. The occupational risk assessments reported in this study largely confirm that the majority of pesticide products identified as highly hazardous pesticides on the basis of hazard criteria would also lead to unacceptable occupational exposure on the basis of risk assessment. Eight out of the nine pesticides showed exceedance of the acceptable operator exposure levels with or without the use of PPE. Only two of these seven (endosulfan and oxamyl) came closer to no exceedance of the AOEL at the lowest registered dose rates, with PPE and for specific application methods. All other, including oxyflorfen showed factors of exceeding the AOEL ranging from about 10x to more than 100000x. Table 3. Summary of the results of the operator risk assessments.Expected effect of the final regulatory action in relation to human health: Reducing the risks posed by the use of HHPs in Mozambique in the context of human health. All registration of oxyfluorfen were cancelled. Date of entry into force of the final regulatory action: 31/12/2014 |