Agrochemicals registration faces regulatory challenges in Brazil

Date:10-10-2012

Considered a key factor to crop protection, regulation has a role to ensure investments for new technological solutions and shared responsibility, for both the market and producer. Today, there is an increasing degree of cooperation among regulatory authorities. As an example, the United States and the European Union make their instructions available to be shared and used by their entities. In relation to the Organization for Economic Cooperation and Development (OECD), of which Brazil will  be a member by 2014, country evaluations will be mostly carried out through a standard study. There will be an intense involvement of regulators in order to speed up the evaluation procedures, with a direct effect in providing to the farmer  faster and easier  access to innovations.

Different Markets demand adequate products, in terms of compliance with test requirements, such as the environmental fate of residues and human toxicological safety. In view of the diversity of regulations and the complexity of factors influencing product registration, CropLife International decided to develop the so called “regulatory principles” with the objective of promoting a more harmonized regulatory system on a  worldwide basis.

A good regulatory system should:

1. Provide a sound policy framework, aimed at ensuring high standards of use and protection for human health and the environment to improve public confidence in chemicals used in food production and in public health applications;
 
2. Be based on scientific principles and risk/benefit evaluation;
 
3. Promote international harmonization in the regulation of pesticides wherever possible, but always taking into account local conditions in defining appropriate risk management measures;

4. Promote data quality and transparency and allow access to useful information by third parties and the general public, whilst protecting confidential business information and intellectual property;

5. Reinforce the responsibilities of each party throughout the production and supply chains for compliance with regulations as well as commitments to responsible action;
 
6. Provide for compliance monitoring and an active response process to manage adverse incidents; 

7. Provide a process to ensure that modern standards are applied to all products in the market; 

8. Require major changes to/revisions of regulations to be preceded by an assessment of their impact.

With the enactment of Law No. 7.802 on July 01, 1989, regulated by Decree No. 4.074 of January 04, 2002, Brazil gave a solid step forward in the direction of establishing alignment with domestic and international agricultural product quality requirements. However, there are some variables to be improved and adjusted. There are three ministries involved in the regulatory area: Agriculture, Livestock and Supplies (MAPA), Environment (MMA), and Health (MS). Although the first one is the responsible for products  registrations, the three ministries have virtually the same power. With different views among them, the regulatory process remains slow and late, with unnecessary repeated work. There is no decision-making priority.

In addition to this lack of alignment an additional problem is the fact that the system is not computerized to enable clear visibility and transparency in the procedures. To fulfill their responsibilities, each agency seeks to obtain their own necessary data, required also by the other agencies, with the consequent multiplication of work among the three ministries. 

Sometimes, the risk mitigation is related to local conditions. This happens in locations with specific characteristics, such as sites where it is difficult to offer training to applicators, in order to prevent major risks when applying the product. We cannot compare the highly technified soybean cultivated in the Brazilian Cerrado with the small horticultural areas. The conditions are different.

In fact, the current Brazilian legislation, in force since 1989, needs to be updated and aligned, with changes and improvements, harmonizing with the regulations adopted by the United States, Europe and other countries all over the world. There is a huge deficiency related to human, technical and financial resources to meet such demand. The United States, for example with a crop protection market of similar size as Brazil’s, has ten times more people involved.

With the increasingly active participation of Non-Governmental Organizations (NGOs) in decisions and discussions about sustainability, the demands on crop protection will become increasingly stringent. The regulatory challenges will increase to meet social demands. The responsibility from private and governmental areas is huge.

According to their own competences, they must work in partnership, in order to  increase the quality and quantity, of food, fibers and energy production.