IBAMA fined 69 agrochemical companies for failure to submit mandatory data on the volume of pesticide imported, exported, produced or marketed. 17 repeat offenders were also made public by IBAMA

On 3 Nov 2016, Brazil ANVISA hosted a public hearing regarding three daft rules on toxicological evaluation, labeling and toxicological ratings of pesticides and components (adjuvants). Currently, the evaluation and classification are made under ANVISA Ordinance 3 of 1992, which is now incompatible with the technical and scientific developments made over the last 3 decades since its implementation. The proposed replacement of Ordinance 3 and the release of the latest draft rules reflect the desire of Brazilian authorities to align its national standards with global best practices and the current state of the art. In addition to the new data requirements and criterion, the adoption of GHS is one of the major innovations in the new drafts. Data Waiving and Prioritization The drafts emphasize administrative and data requirements for toxicological evaluation of technical product, formulated products and components and offer clear criteria for data waiving and prioritization of certain products: The toxicological study report of biological products can be replaced by relevant scientific literature or studies conducted by public or private research institutions demonstrating adequate safety If the technical product or component has been evaluated/registered with another Brazilian authority which has similar measures and criterion on toxicological evaluation, the results can be used during ANVISA’s evaluation The analysis of low toxicity products (non-skin sensitization, non-skin/eye corrosive/irritating, non-carcinogenicity, non-mutagenicity, non-teratogenic and non-endocrine disruption) will be expedited and prioritized by ANVISA and biological agent, semi -chemicals and microbiological products will be generally considered as low toxicity products. Applicants may apply for the prioritization exclusively through electronic submission; Negative List of Pesticide Components A list of components subject to toxicological evaluation will

On 29 Aug 2016, Brazil ANVISA published Resolution 2297 on the Official Gazette to cancel the approval of methyl parathion pesticides from the 1st of Sep 2016.

On 17 Aug 2016, the SDA/MAPA (Secretary of Defense Agricultural, MAPA) published a departmental ordinance on administrative procedure for the agronomic revaluation of 117 pesticides registered for soybean rust (Phakopsora pachyrhizi), most of which are bestselling triazoles and strobilurins. Affected companies will have 60 days to submit the scientific evidence to confirm the efficacy of their products against biological targets, otherwise pesticide approvals will be suspended within 30 days.

On 18 Jul 2016, the IBAMA released a normative instruction (IN No.3 on 15/07/2016) concerning the emergency registration of two active ingredients to combat invasive species in reserved land. Glyphosate and triclopyr herbicides which meet specific criteria for a designated use site, dosage and application method could be granted with a 2 year extendable emergency registration.

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.

On 11 May 2016, Brazil National Health Surveillance Agency (ANVISA) published a technical note to specify two exemption conditions for acute inhalation toxicity test for pesticide formulation and the applicable result for toxicological classification of pesticide. In Brazil, the inhalation toxicity data are mandatorily required for pesticide registration and the study should be performed under internationally recognized methods and the OECD test protocols most often accepted. The latest OECD Test Guideline 403-Acute Inhalation Toxicity has been appended with new procedures and parameters for lethal concentration inhalation study. ANVISA deems it is necessary to consolidate the technical reference with the requirement, acceptability and interpretation of study result to determine the endpoint.

On 2 May 2016，the Brazil Secretariat of Agriculture Defense of MAPA(Ministry of Agriculture, Livestock and Supply) issued a consultation notice on a draft normative instruction for pesticide labeling and collecting concerning information into the Plant Protect Product System-the Agrofit System.

On 22 April 2016, the Brazil ANVISA published the “Application Form for the Inclusion or Alteration of Referenced Technical Product” to concerning registrant who wishes to include or modify product into/in the “Positive List of Technical Product for Equivalent Reference”. The list contains the active ingredient, trade name, registration number of the technical products can be appointed as reference product by other applicant who proposed for pesticide registration under equivalence category.