What Brazil’s Approval of Emamectin Benzoate Really Means

“It is vital to note that the regulatory approval of emamectin benzoate is not for emergency registration, but for emergency authorization of import and use.” -Flavio Hirata

“It is vital to note that the regulatory approval of emamectin benzoate is not for emergency registration, but for emergency authorization of import and use.” -Flavio Hirata

The caterpillar Helicoverpa armigera, an exotic species in Brazil, has had a devastating effect on primarily cotton, maize and soybean crops – some of the most important agricultural commodities in Brazil. First observed in the Cerrado region of Brazil in February 2012 at population levels never seen before, infestations have since been reported in dry beans, cowpea, millet, sorghum, tomato, pepper, coffee and citrus throughout the country. Cumulative losses already total $5 billion.

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The caterpillar has raised enormous concern because of its high capacity to feed on several plant species, its high reproductive capacity, resistance to insecticides and quick adaptation to different environments.

Brazilian authorities, research institutions, pesticide companies, as well as farmers and their associations joined efforts in order to find more efficient ways of managing the caterpillar population. Several measures are recommended for monitoring and subsequent control. Among them, biological and chemical control agents are recommended such as Trichogramma pretiosum; Baculovirus Helicoverpa zea NPV; Baculovirus H. armigera NPV; Bacillus thuringiensis; virus VPN HzSNPV; Trichogramma spp.; pheromones and baits.

 

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Besides the chemical control methods shown in the table, there was significant pressure by agricultural groups to approve emergency registration of emamectin benzoate. It is worth noting that emamectin benzoate’s registration request was rejected in 2007 by ANVISA due to toxicological concerns.

Actions by the interested parties resulted in many regulation approvals and changes – including the recent presidential decree to authorize the import and use of the product, under the condition that the application is approved in the state where the product is to be applied.

It is vital to note that the regulatory approval of emamectin benzoate is not for emergency registration, but for emergency authorization of import and use. This distinction is important because it conflicts with some state regulations that require product registration to apply pesticides. If the product doesn’t have registration approved at the federal level, it can’t receive the appropriate regulatory clearance for registration at the state level.

Different from any other permit in Brazil, the emergency registration or registration for pesticide sales/applications process initiates from the end-user, as described below, in such a way that in order to import the product, it must be revealed where it will be applied.

Steps for the import and application of emamectin benzoate:

–       The State should declare a phytosanitary risk of an outbreak of Helicoverpa armigera

–       Ministry of Agriculture declares for this specific State or area in this State as a state of emergency

–       Authorization for application issued by State Department of Agriculture (*)

–       Approval of the import license by Ministry of Agriculture at state level

–       Additional documentation, label and booklet approved by Ministry of Agriculture at federal level

–       Import product

–       Imported product should be applied under control of the State Department of Agriculture

(*) Required information for authorization for application issued by State Department of Agriculture:

–       Technical responsible for the farm informs State Department of Agriculture concerning the Helicoverpa infestation

–       Detailed location of the farm

–       Crop to be applied

–       Application area (ha)

–       Product amount

Considering the peculiarities of this case, it is virtually impossible for foreign players to directly access this market without local partners. Forging strong partnerships between foreign and local companies is crucial for success in Brazil.

In addition of all these complex proceedings, there are lawsuits against the use of non-registered products. In the state of Bahia, which is No. 1 in cotton production, for example, even with all approvals for application, it is not possible because of an injunction that does not authorize it. To date, no company has obtained a permit to apply emamectin benzoate in Brazil.

Once again, partnerships between foreign and local companies have been increasingly critical for success in agribusiness.

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