Research, testing, production, packaging, labeling, transport, storage, marketing, commercial advertisement, use, import and export, final destination of waste and packaging, registration, classification , the control, inspection and inspection of agricultural pesticides are governed by Law 7.802 / 89. Currently this Law is regulated by Decree 4.074 / 02.
Law 7.802 / 89 established general rules on the prohibition of registration (and consequently the production, export, import, marketing and use) of agricultural pesticides. Briefly, agricultural pesticides that have teratogenic, carcinogenic or mutagenic characteristics and that cause hormonal disturbances, damage to the reproductive system, according to up-to-date procedures and experiments in the scientific community, are prohibited; that are more dangerous to man than animal laboratory tests have been able to demonstrate, according to up-to-date technical and scientific criteria; and whose characteristics cause damage to the environment.
Decree 4.074 / 02 specified the criteria to be used in the identification of these pesticides, bringing an important concept to be considered: risk assessment. In fact, Decree 4.074 / 02, when establishing the Technical Advisory Committee for Agrochemicals – CTA (composed of MAPA, IBAMA and ANVISA), established in its art. 95, as an attribution of this Committee, the important task of developing, until December 31, 2002, routines and procedures aimed at the implementation of the risk assessment of pesticides and the like.
Unfortunately, however, to date the routines and procedures for implementing the risk assessment have not been defined and published by the competent federal bodies.
Fifteen years after its implementation for the evaluation and reassessment of agricultural pesticides, in practice there are still discussions on the interpretation of the legislation put in place in relation to this determination and also the need to publish the publication of a new Law, or a new Decree or, still, of other infralegal norms in the area of health and the environment.
Risk assessment is a scientific tool for systematizing the information available for decision making. Its importance has been recognized internationally for many years and has been used since the 1970s as a tool for regulatory decision by major agencies such as EPA and FDA in the USA and EFSA in Europe.
Once the risk associated with a particular chemical has been assessed, this information should be used to determine how best to manage and regulate that substance. The risk assessment aims to identify the possible risks of substance use. It is on the basis of this identification that the Public Administration will be able to determine what is acceptable or not.
In this sense, the use of this tool (risk assessment) is indispensable, even for a real characterization of what will become a substance with characteristics of teratogenicity, carcinogenicity, mutagenicity or that cause hormonal disorders and damage to the reproductive system.
It is true that government has a duty to ensure the necessary and effective protection of citizens, but it is important to understand that one can not live in a society free of risks. It is the achievement of the balance and effective participation of all those involved in the process that guarantees the growth of society.
The determination for the implementation of the risk assessment, established by Decree 4.074 / 02, recognizes that the Government can not regulate with the objective of removing all risks (zero risk), but recommends that the regulatory decision, when taken, must be reasonable, proportional and based on risk weighting and management.
This is the biggest challenge in regulatory assessment: to have consistent data, and above all related to exposure levels under the proposed conditions of use.
To take up this challenge, the Public Administration does not have to wait for the publication of new standards that put a spade of lime in the interpretation of the legislation. The new rule may define the best procedure in its implementation, but this will not be enough if it is not accompanied by a full understanding of the concept of risk assessment and its scope.
Lidia Cristina Santos, financial director of the Sustainable Agricultural Scientific Council (CCAS), and associate lawyer at Figueiredo e Santos Law Firm