New risk assessment principles will be implemented to protect bees. The initial implementation will use simple and practical methods and will be scaled up gradually to address the complexity and importance of this issue. The principles will then be expanded to include other organisms/ecosystems.
On Feb 10 2017, Brazilian IBAMA issued the “Normative Instruction 2” on Federal Official Gazette to establish the guideline and procedures for the environmental risk assessment of pesticides against pollinators.
Scope and Procedures
Risk assessment covers new active ingredients not yet registered in Brazil, registered active ingredients subject to revaluation and new applications of formulated product containing active ingredient subject to revaluation. The assessment classifies pesticide usages into two categories (foliar application and non-foliar application) and the assessment will be divided into 4 phases, starting from the simplest and most conservative phase and proceeding to more complex and realistic phases according to the necessities:
- Bee Rex: predictive model developed by the US EPA to calculate the risk of pesticides against bees during phase 1.
- RQ (Risk quotient): calculated on the Bee-REX, is obtained from the ratio between the Estimated Environmental Concentration (EEC) and the toxicity parameter (LD50, NOAEC, etc.).
- AGDrift: predictive model developed by the US-EPA to estimate spray drift.
The normative instruction supplements the item D4 of annex IV and V of the IBAMA Ordinance 84 on 15 10 1996 with more defined specification and test items required for environmental risk assessment on bees:
Technical product and formulated product
Acute oral toxicity to adult bees (adult LD50）
Technical product and formulated product
Acute contact toxicity to adult bees (adult LD50）
Chronic oral toxicity to adult bee(NOAEL)
Acute oral toxicity to larva(LD50)
Chronic oral toxicity to lava(NOAEL)
Residual foliar toxicity test: For spray applied products only, where the LD50 of contact is <11 pg of active ingredient / bee. For the residual toxicity test the study shall be conducted at the highest dose per formulation type.
The tests results of bees are granted a period for data protection and IBAMA will disclose the active ingredients that have completed dossiers and expiration of that data. If the test results of a technical product were accepted by IBAMA and the data is no longer protected, it will be utilized for the reevaluation of other registered products or application evaluation of other products containing the same active ingredient(s).
After the first phase of the assessment, the study will be made in accordance with the characteristic of active ingredient and usage of the pesticide. If it is necessary to generate residue data to refine the assessment, the test should be carried out in brazil and the tested crop is preferable covered by the product usage. The maximum residue value will be utilized for the calculation of acute risk, chronic risk and mean daily residue of stress agent (active ingredient, metabolite and degradation product which may potentially cause an adverse effect) by exposure model, crop and application method on a case-by-case basis.
The crop should also be selected taking into account grouping and priority order, which were also established in the Annex III of the normative document. If the product usage covers more than one crop of the same group in Annex III, the applicant/registrant should carry out the test with at least one crop of the group in accordance with crop priority. If the residue data of a formulated product was approved by IBAMA for the risk assessment then another product with the same active ingredient, crop and application method and equal or less dosage can be exempted from residue study using the same model. The residue data in a given exposure model may be extrapolated to other crops within the same group. IBAMA will disclose the availability of the residue data on the crops with information on the dosage and application method, including the residue level per each exposure model and the period of data protection.
GLP and GAP Condition
In principle, the study for the risk assessment should be conducted in GLP(Good Laboratory Practices) and GAP(Good Agricultural Practices) condition in accordance with the guidelines and test protocols recognized by IBAMA, Exceptionally, if there is no defined study protocol or the study was not conducted under GLP principles, the result may be accepted by IBAMA provided the raw data is provided and the traceable.
Although the normative instruction is specific to the risk assessment on bee, it provides the principle for the environmental risk assessment of pesticide registration, which will be extended to the evaluation of other organism and ecosystems.
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