Chemical name: 2,4(1H,3H)-Pyrimidinedione, 5-bromo-6-methyl-3-(1-methylpropyl)-

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 formulations containing Bromacil active ingredient, as well as all uses in Costa Rica, are 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:

Water analysis were carried out in two aquifers located in the Atlantic area of ??the country where the presence of bromacil was determined, and since 12 September 2014 the contamination of the waters of 3 aqueducts located in this same area was confirmed.

The National Service of Groundwater, Irrigation and Drainage (SENARA) prepared the Matrix of criteria for agricultural land use, according to the vulnerability to contamination of aquifers for the protection of the water resource, in addition the AYA, in 2009, contracted a hydrogeological vulnerability study in two basins in which the water intakes of the aqueducts takes place, where the contamination of the waters was confirmed, concluding that they are of high and extreme hydrogeological vulnerability.

In 2011, SENARA contracted a second hydrogeological vulnerability study in the same basins, observing that the study area is highly vulnerable, from the hydrogeological point of view; to a lesser extent in the Destierro river basin there are areas with medium vulnerability.

In September 2015, the National Environmental Council agreed to commission the Ministers of Health, Environment and Energy and Agriculture and Livestock to present a proposal and a roadmap to address the contamination of aquifers and water bodies problem by agrochemicals used in the cultivation of pineapple in that region.

The Inter-Institutional Commission, coordinated by the Ministry of Health, for the elaboration of a single Plan to address the water contamination by pesticides issue in Desierro and Peje river basins, called for an institutional sub-commission to prepare proposals for the management of the aforementioned basins, in November 2015, and constituted by the Ministry of Health (as coordinator), the Ministry of Agriculture through the SFE, the Ministry of the Environment through DIGECA and SENARA and Aqueducts and Sewers (AYA) who issued sanitary orders, carried out hydrogeological studies, control of wastewater reuse to avoid dumping in medium and high risk areas, monitoring of water and surface sources, and also coordinated the work with the National Chamber of Producers and Exporters of Pineapple (CANAPEP) so that elimination of Bromacil was done gradually to do not affect producers.

The single Action plan is then created and approved, the most important steps are: prohibit the import of Bromacil at the national level, continue with the inspections of the warehouses and farms in the area, continue with the sampling plan of the aqueduct water, continue to follow up on the sanitary order issued in 2008 that prohibits the use of Bromacil on farms in the affected area and continue to inform the Environmental Administrative Tribunal on the actions taken to provide feedback on the 3 files opened to this respect.

On May 10, 2016, representatives of the Ministry of Agriculture - SFE presented information and graphs pointing to the levels of persistence allowed at the international level of Bromacil in the water, so it was agreed for the next session that the Minister of Health, in his quality of rector of water, will make a report on the status of the Bromacil situation and present the scientific comparison with respect to the observations made by the MAG-SFE.

On 5 July 2016, the Minister of Health exposed the problem, in the Atlantic Zone since 2002, regarding the persistence of Bromacil since the current drinking water regulation was ignored in terms of maximum levels, for which article 273 and 277 of the General Health Law was applied, where it is stated that it is prohibited to contaminate water supplies and that natural or legal persons must use water that meets the qualities required by the Ministry, and for this reason, from 2008 and 2009 the populations of the area have been supplied by drinking water tanks. The Director of DIGECA explained that the Unique Plan of the Pineapple presented in 2015 was elaborated together and approved by the ministers, it was a more comprehensive plan, not limited to the prohibition of the Bromacil but urging that it should be prohibited, in addition the Minister of Agriculture clarified that in the visit of the European Union, the Costa Rican pineapple sector affirmed that Bromacil is no longer used; and in this ordinary session of the National Environmental Council was discussed that the most convenient thing is to unregister Bromacil from the pesticides registry.

As an agreement of this session, it was decided to proceed with the corresponding steps to eliminate Bromacil from the pesticides registry, or, otherwise opting for banning Bromacil in specific areas with there water vulnerability based on SENARA studies and hydrogeological maps.

On 4 July 2016, in the ordinary session, the progress of the fulfilment of the Single Action Plan was presented, and can be found in Annex II.

On October 25, 2016, the Vice Minister of the Ministry of Agriculture and Livestock requested to designate representatives of MINAE, MTSS and Health to form up the National Monitoring Committee for the pineapple sustainability initiative, where the two strategic ways are the use and conservation of soils. In addition, priority actions were identified to adopt the best practices for the use and conservation of soils, management and handling of pineapple stubble, management and control of phytosanitary problems, measures to mitigate the impacts of climate change, differentiation of pineapple in national and International markets and to stimulate the production of organic pineapple; in this ordinary session the progress report of the sustainable pineapple project presented by the Vice Minister is considered received.

On 15 May 2017, the head of the MAG's Legal Department indicates to the Executive Director of the State Phytosanitary Service - MAG, that by request of the Minister of Agriculture and Livestock, will draw up the Executive Decree to prohibit the use of Bromacil in the national territory, on the grounds that using this pesticide many pineapple-producing farms have a high risk of contaminating groundwater, aquifers and humans, in addition requesting the technical justification draft for the elaboration of this decree; the Executive Director of the SFE-MAG answered on May 26 indicating that for registration and prohibition of a pesticide three institutions are necessary: the Ministry of Environment and Energy (MINAE), the Ministry of Health (MS), and SFE-MAG, where each one of them carries out an evaluation in the scope of its competence; SFE-MAG has to evaluate the agronomic information of the pesticide and, from the agronomic point of view, the biological efficacy and the phytotoxicity of Bromacil, which does not present problems that justify its prohibition since said pesticide meets all the requirements for its use in the crops for which is registered, therefore there is no scientific foundation. In addition, the Director indicates that from the toxicological and ecotoxicological point of view the Ministries of Health and Environment and Energy must issue the technical criteria within the scope of their competence and therefore the SFE-MAG does not have the technical competence to issue a justification that allows the prohibition of Bromacil for presenting a high risk of contaminating groundwater, aquifers and affecting human health, so the technical justification to draw up the prohibition decree must be requested from MINAE and MS.

The reasons for the final regulatory action were relevant to: Environment

Summary of known hazards and risks to human health:

Although a health risk assessment was not performed, the levels of Bromacil in drinking water raised a health concern.

Expected effect of the final regulatory action in relation to human health:

Reduce potential exposure to Bromacil from the consumption of drinking water with this pesticide, in compliance with Executive Decree 38924-S Regulation for the Quality of Drinking Water and its reforms.

Summary of known hazards and risks to the environment:

In Costa Rica, before Executive Decree 40423-MAG-MINAE-S entered into force, four technical grade active ingredients (IAGT) and six formulated products were registered whose IAGT was Bromacil and whose use was for the cultivation of pineapple and citrus, these pesticides are currently cancelled. Annex II shows the summary table of the formulated products mentioned above, where their formulation, toxicity, band colour, uses, dose and application interval and harvest interval are detailed.

Within the hazard identification of Bromacil, the value of toxicity for fish, toxicity for daphnia, toxicity for algae, persistence in soil, water-sediment, mobility, bioaccumulation and solubility is determined, these are shown below:

Toxicity to fish, LC₅₀ 36Daphnia toxicity, EC₅₀ 119Toxicity to algae, LC₅₀ 0.013Persistence in soil (Laboratory at 20°C) DT₅₀ 60Persistence in soil (Laboratory at 20°C) DT₅₀ 60Persistence in water-sediment (DT₅₀ water) DT₅₀ NDMobility, K_oc or K_foc32Bioaccumulation BCF (l/kg) 2,8Solubility, mg/L815GUS index¹LC50: Medium Lethal Concentration; EC50: Average Effective Concentration; DT50: Koc/Kfoc Half Life: adsorption coefficient or soil-water partition coefficient

From the above information, the hazards were characterized with the GUS1 index, which is reported higher than 2.8, therefore, it has a high contaminant potential in the aquifers.

In 2014, water contamination of in the Atlantic Zone of the country was confirmed, especially the pesticide Bromacil, in the aqueducts Milano, Louisiana, France and Cairo de Siquirres, by different water analysis that were carried out, and the identified levels are presented listed as 17/24, 18/24 in Annex I.

Additionally, two vulnerability studies were carried out in Peje river and Destierro river basins, in which the water intakes of Cairo, France, Louisiana and Milan in Siquirres and Gucimo aqueducts are located, in the first study, carried out in In 2009, it was determined, according to the GOD2 index, that Peje and Destierro river basins are of high and extreme hydrogeological vulnerability, the above is reflected in the following map:

In the second vulnerability study, carried out in 2011 and using DRASTIC3 methodology, with a greater level of detail, it was determined that the study area is highly vulnerable, from the hydrogeological point of view, to a lesser extent, in the basin of Rio Destierro there are areas with medium vulnerability (the map obtained from this study can be viewed in Annex I page 6/24). The experts who carried out this study determined that in the lower middle basin of Destierro and Peje rivers, the vast majority of the pineapple cultivation areas were located in areas of high vulnerability, in addition pineapple crops can be found into the immediate recharge zones of the Milano river's source and in the closest area to the sources of Cairo river.

Additionally, concentrations of Bromacil were identified in the water samples analysed in the aqueducts of Cairo, France, Luisana and Milano that exceeded what established in Executive Decree 38924-S Regulation for the Quality of Drinking Water and its reforms; which establishes that the Maximum Allowable Value (VMA) of Bromacil, Diuron and Triadimefon in groundwater is ND (Not Detectable).Taking into account the potential risk for the human health, actions were generated by the different State institutions, such as, for example, the suspension of water consumption from the aforementioned aqueducts for the preparation of food or direct intake; the supply of drinking water in these areas was carried out by cisterns.

Taking into account this risk assessment for the contamination of aquifers that are used for human consumption, it became necessary to prohibit the use of Bromacil and its lithium salt.

Expected effect of the final regulatory action in relation to the environment:

Eliminate contamination of aquifers with bromacil

Date of entry into force of the final regulatory action: 05/06/2017