Reginaldo Minaré is the executive director of the Brazilian Bioinputs Association – ABBINS, a lawyer with a bachelor’s degree in Legal and Social Sciences and a M.Sc. in Law from the Methodist University of Piracicaba.
Minaré served as legal adviser to the Brazilian National Technical Commission on Biosafety, as legal adviser in the Federal Senate offices of Senators Kátia Abreu and Álvaro Dias and as deputy technical director of the Brazilian Confederation of Agriculture and Livestock.
AgriBrasilis – How could the Bioinputs Law reshape the Brazilian market?
Reginaldo Minaré – It depends on the implementing decree that the Executive Branch drafts for the Bioinputs Law. The government could establish rules that keep the market open to competition or burden it with bureaucracy, creating artificial barriers and handing the bioinputs market over to large multinational companies.
What is best for Brazilian agriculture is a dynamic market without artificial barriers or privileges.
However, we feel the government lacks the courage to confront large agricultural input corporations and some Embrapa researchers who dream of doing business with multinational companies. Embrapa’s microbial culture collection, which was built with public funds, could be used to benefit large multinational companies instead of Brazilian agriculture directly.
The Bioinputs Law is the beginning of a new regulatory framework, but its implementing regulations could undermine the very objective the Law sought to achieve.
AgriBrasilis – What are the consequences of delays in regulation for farmers, manufacturers and investors?
Reginaldo Minaré – The consequences can be positive or negative, depending on the economic interests involved. For the pesticide market, delays in regulation are excellent because they reduce investment in bioinputs that could replace pesticides to a significant extent.
We believe the delay in regulating the Bioinputs Law is another example of Brazil wasting opportunities.
The bioinputs market has grown by an average of 15% per year in recent years. With well-designed regulation, we could grow between 30% and 35% per year.
AgriBrasilis – What are the main disagreements over regulation of the Law?
Reginaldo Minaré – We argue that the registration, production and use of bioinputs should be governed by their own regulatory framework, as established by the Bioinputs Law. Bioinputs are not pesticides.
However, representatives of the pesticide industry are lobbying the government to apply the regulatory logic of pesticides to bioinputs. That would be a setback that would only benefit shareholders of large pesticide companies.
Representatives of large pesticide companies and some bioinput companies want a bureaucratic regulatory framework with a lengthy and costly registration process that makes it difficult for new small companies to enter the market. They also want an implementing decree containing some regulatory workaround that would restrict access to microorganisms for small and medium-sized companies and farmers. Our Patent Law wisely does not allow naturally occurring microorganisms to be patented because they are not inventions.
The fact that naturally occurring microorganisms cannot be patented is keeping many people awake at night because they wanted to make a fortune from an asset that is available for common use.
AgriBrasilis – What criteria should determine when a new strain or formulation constitutes a new product?
Reginaldo Minaré – We argue that a new product is one containing a strain of a species for which no strain has yet been registered for agricultural use. As a new product, it would undergo evaluation by all three agencies: the Ministry of Agriculture and Livestock, Anvisa and Ibama.
A product based on an already known species would go through the Ministry of Agriculture and Livestock, which could request an opinion from other government agencies or universities if it considers this necessary for a specific aspect.
It is also worth emphasizing that this distinction for new products, which applies specifically to products intended for phytosanitary purposes, is the result of lobbying by the chemical industry. The distinction makes no sense because the same microorganism may be used for both fertilization and phytosanitary control. It is in the Law precisely to allow barriers to be created through regulation because bioinputs for phytosanitary purposes are the products that will replace pesticides wherever replacement is possible. By creating barriers to these bioinputs, the market for chemical pesticides can be prolonged.
AgriBrasilis – What are the costs and time required to register a bioinput? What is expected under the new Law?
Reginaldo Minaré – The Bioinputs Law has an annex establishing registration fees ranging from R$ 350 to R$ 3,500, approximately US$ 68 to US$ 681. The largest cost will be the studies required for registration and this will depend largely on the quality of the implementing regulations for the Bioinputs Law.
AgriBrasilis – How can the quality of bioinputs produced on-farm be ensured without making on-farm biofactories unviable?
Reginaldo Minaré – All that is needed is for the greed of some companies and researchers not to get in the way of Brazilian farmers.
Brazilian farmers have been producing their own bioinputs on-farm safely and with adequate quality for 15 years. Hundreds of fruit farmers use bioinputs produced on-farm, supply the domestic market and export to dozens of countries without problems.
In 2009, President Luiz Inácio Lula da Silva issued a decree that exempted phytosanitary products approved for organic agriculture and produced exclusively for on-farm use from registration. Farmers adopted the practice.
In 2009, no Embrapa or university researcher criticized the decree. Now that on-farm bioinput production has taken market share away from multinational companies, some researchers have begun seeing enormous dangers where, until recently, they saw no risk at all.
This could be the easiest part of implementing the Bioinputs Law if there were no commercial dispute over market share.
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