Regulations Update

By Renee Targos
Editor

Brazil’s big regulations news is the passing of Law 14.785 on 28 December 2023, replacing and repealing Law 7,802/1989. After 20 years of discussion in the National Congress, the new law will harmonize standards and improve processes for chemical pesticides.

Viviane Kunisawa, Partner with Daniel Law, a Brazilian intellectual property firm, says the new law makes it mandatory to include risk analysis in the registration process. In the past, technical staff would decide if the inclusion of risk analysis was necessary.

Viviane Kunisawa,  Daniel Law

“While regulatory agencies like the National Health Surveillance Agency (ANVISA) and the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) have already adopted risk analysis protocols, the inclusion of these measures in the law brings legal certainty to all users of the system,” says Kunisawa.

Javier Fernandez, Legal and Regulatory Affairs Director for CropLife Latin America, says, “It’s going to cement the very long debate on risk analysis and risk assessment, and what was being done by agencies at times with discretion. It really nails down the risk assessment process, which was very needed in Brazil.”

The law also is seeking to harmonize Brazil’s regulations with international standards established by Globally Harmonized System of Classification and Labeling of Chemicals (GHS), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Codex Alimentarius.

“This new law is a major overhaul of the Brazilian regulatory system,” says Fernandez. “It’s an omnibus. It regulates the whole life cycle of the of the products from research, testing, packaging, labeling, transportation storage, even illegal trade imports, exports, and whatnot. I think that’s it’s going to be a major breakthrough.”

Biological Disputes

As Brazilian growers increase their use of biologicals to combat disease, weeds, and pests, more products are needed for their toolbox. Brazil’s government is working to manage expectations of both growers and the industry, while working to improve the biologicals regulations process.

Gisele Perjessy, CropLife Brazil

“There is a Bill of Law in discussion in Brazil’s Congress to regulate all biological products for agriculture,” says Gisele Perjessy, Regulatory Affairs Coordinator of Biological Products with CropLife Brazil. “We expect that the Chamber of Deputies will continue this discussion in March. We are monitoring and working on positioning regarding the roles of ANVISA and IBAMA in the process of authorization of biological control products and biostimulants.”

Kunisawa adds, “The major issue of dispute between farmers and industry is how to regulate farm production of biological products. We expect new developments toward a new law for 2024.”

Brazil’s biologicals regulation process, a system that moves faster than most regions globally, continues to welcome new products. Currently, “marketing approval of biological products under the current regulations has been taking an average of six months to be granted, but may take up to two years, depending on the type of active biological, and its origin,” Kunisawa says.

South American Countries

CHILE

In Chile, the country’s regulatory system had been contemplating reevaluating registrations of up to 100 active ingredients with hazard-based guidelines, starting with a priority of 20 in 2023.

Javier Fernandez, CropLife Latin America

“Agriculture and Livestock Service (SAG), the Chilean regulatory agency, appointed Jose Guajardo Reyes as National Director. They quickly established a public-private round table on pesticide policy,” said Fernandez. “The idea of a list of compounds and evaluation guidelines was abandoned. Instead, SAG will review six molecules, but it remains to be seen under which criteria.”

There is also a draft regulation addressing pollinator health under consultation that could introduce restrictions including excessive buffer zones and require pictograms in labels that are not consistent with international accepted standards.

COLOMBIA

In 2023, the Colombian court system instructed authorities to address pollinator health concerns associated to use of fipronil. The authority was quick to ban all uses (even veterinary) of fipronil instead of working on risk mitigation through a public-private working group. A similar court decision inspired cancellation of chlorpyrifos registration.  Neonicotinoids continue to be the target of activists looking to protect bees.

“The court system is becoming a player in the pesticide policy world in Colombia, so that’s the new reality,” said Fernandez.

This may bode well for activists who stir up emotional responses from the public to advocate for politicians to make quick decisions.

ECUADOR

The country introduced a new regulation for re-entry interval last year. The new system was inspired by the U.S. Environmental Protection Agency, which also offered training.

“It’s a very healthy working system,” says Fernandez. “When regulators have a question, they go to the industry. Recently, a technical paper was discussed to move along with implementation of the guidelines. It is a great example of how collaboration between regulators and industry experts can work together in finding a solution.”  •

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JC_STOCKER – stock.adobe.com
Javier Fernandez photo courtesy of © Javier Fernandez 2024
Gisele Perjessy photo courtesy of © Gisele Perjessy 2024
Viviane Kunisawa – Daneil Law