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 Severely Restricted Use or uses prohibited by the final regulatory action: Banned in horticulture and fruit crops and in aerial applications Pesticide use or uses that remain allowed: Allowed on extensive crops, soybeans and grain cereals The final regulatory action was based on a risk or hazard evaluation: No Summary of the final regulatory action: TO ESTABLISH, that SENAVE will authorize specific cases for the acquisition of analytical standards, only for laboratory use purposes. SUSPEND, granting new registrations, issuing Prior Authorization for Import (APIM) and import in the country, and technical grade products formulated with Endosulfan in all concentrations. DISPOSE, banning the use of Endosulfan formulations on horticulture and fruit crops, in all concentrations and formulations. ESTABLISH, that all products with Endosulfan, active ingredient shall include into the container the label "PROHIBITED ON HORTICULTURE AND FRUIT CROPS ", been responsibility of the registrants to include this recommendation for marketing and use of the products. DISPOSE, the gradual disposal of Endosulfan in extensive crops, within two (02) years from the entry into force of the present resolution. ESTABLISH, the ban of aerial applications with Endosulfan formulations and shall include into the container the label "AERIAL APPLICATION PROHIBITED", been responsibility of the registrants to include this legend for marketing and use of the products. DETERMINE that the use of formulations based on Endosulfan, will be severely restricted, and the use will be authorized only with ground application equipments in extensive crops. Products severely restricted are banned almost entirely, in order to protect the human health or the environment, and only certain specific uses remain allowed. ALLOW, exportation, marketing and use of products formulated with Endosulfan, in all concentrations, until the completion of the period for the entry into force. To this end, registrants of these products shall submit to SENAVE, an affidavit made by notary, regarding stocking and projection of sale and / or use of this pesticide, within 45 days from the date of entry into force of this Order. ALLOW, importation and entry of the products if import authorizations (APIM) were issued before the entry into force of this resolution. KEEP record of all existing products, with obligation of maintenance, with no obligation to submit the studies required as confidential information, from the entry into force of this resolution and for a period of two (02) years. ESTABLISH, that once granted the maximum period specified on previous article, all products formulated with Endosulfan should be withdraw, disabled or destroyed, and the cost should be covered by the registrant and /or the importer. "THUS, ISSUING OF NEW RECORDS AND IMPORTING IN THE COUNTRY OF TECHNICAL GRADE ENDOSULFAN PRODUCTS OR FORMULATIONS IN ANY CONCENTRATION, IS SUSPENDED" The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: It is characterized as extremely dangerous and there are concerns of adverse effects to human and animal health, to the flora and the environment, according to the conditions of use and handling of these products in the country, it is commonly used by farmers and has a high dose per surface unit. The lack of habit in the use of Personal Protective Equipment (PPE) increases the risk of poisoning to applicators. Also withholding periods are not usually respected by farmers, which increase the risk of poisoning in consumers. Expected effect of the final regulatory action in relation to human health: Obtain fruits and vegetables free of contaminating residues. Reduce the risk of poisoning for operators /handlers, and the environment. Increase protection to the environment and to the human health with focus on rural and indigenous communities. Summary of known hazards and risks to the environment: As this product is not selective, it is moderately toxic to bees, (Harmless in concentrations up to 1.5%). Moderately toxic to birds. Extremely toxic to fish. Expected effect of the final regulatory action in relation to the environment: It is scheduled commercialization, with present restraints, for products formulated with Endosulfan until existing stocking will last, for a period of two years. Date of entry into force of the final regulatory action: 03/11/2010 |