As one of the authorities involved in pesticide registration in Brazil, ANVISA is also responsible for the toxicological reevaluation of previously registered pesticide. Current administrative procedures for pesticide reevaluation due not have a referenceable timeline or standard schedule. ANVISA approved a regulatory initiative to propose a new rule on the procedures of pesticide reevaluation which will offer greater transparency and predictability
On 14 Jun 2016, Brazil ANVISA approved a regulatory initiative to amend the procedure for pesticide reevaluation, aim at bringing more transparent and predictability during reevaluation process of pesticide with evidence of altered risk to human health.
Currently, pesticide reevaluation is defined by ANVISA’s Collegiate Directorate Resolution (RDC) 48 of 2008, which provide the administrative procedures for the toxicological re-evaluation of technical products and formulated products containing active ingredient with health concern:
The GGTOX (General Executive of Toxicology under ANVISA) should proceed with toxicological reevaluation when new data is presented related to pesticide risk to human health or new information is presented by international organizations of health, food or environment;
ANVISA will publish the Collegiate Directorate Resolution on the concerned active ingredient and affected registrants will have 30 days to submit all toxicological studies and decide if they have interest in supporting the toxicological dossier on the active ingredient, otherwise the registration would be cancelled;
GGTOX / ANVISA will analyze the data contributed by the registrant and published scientific studies and publish technical note on toxicological and regulatory aspects of the reevaluated active ingredient, which will be subject to public consultation for 30 days;
The reevaluation result and public opinion will be further discussed by a reevaluation commission summoned up by GGTOX / ANVISA, which comprised of representatives from the ANVISA, MAPA and IBAMA. The conclusion will be forwarded to the Collegiate Directorate/ANVISA for final decision. The ANVISA, MAPA and IBAMA delegates may monitor all steps of the reevaluation and have access to all the information;
The procedures do not address any complexity and provide timeline for the revaluation. As a part of pesticide evaluation modernization, ANVISA approve the regulatory initiative. A proposed rule on pesticide toxicological reevaluation will be drafted and submitted for public consultation.
