Debora Leite Debora Leite

Biotech Division Manager at Vigna Brasil – Consultancy in Strategic and Regulatory Affairs
    There is no doubt South America is an agricultural continent: accounting with more than 30% of the agriculture harvested area in the world, this region is responsible for over 12% of all the food exports. With a promise to boost this market and bring greater facilities to farmers, biotech-derived genetically modified (GM) crops were introduced into South America and their adoption is rapidly increasing since they were first approved for cultivation in Argentina in 1996. In recent years, Brazil and Argentina have sustained their position among the world’s top five countries growing biotech crops, while Paraguay and Uruguay are among the top 10 (Table 1).

    Table 1: Area planted with biotech crops in 2015*
    Country
    Area (million hectares)
    Brazil
    44.2
    Argentina
    24.5
    Paraguay
    3.6
    Uruguay
    1.4
    Bolivia
    1.1
    Colombia
    0.1
    Chile
    <0.1
    TOTAL
    74.9
    (*Source: ISAAA)

    In order to have GM events authorized for cultivation and/or use as food or feed in countries with established regulatory framework, the applicant company should present a risk assessment to national authorities, who will issue a decision on that. The standard requirements for the risk assessment are defined by the country’s biosafety legislation, but they are supported by principles stated in the Cartagena Protocol on Biosafety (CPB - Box). Nevertheless, GMO regulation and approval in South America is quite diverse, and so is the regulatory framework in each country, reflecting the cultural and political background.

    According to Biosafety Scanner, Argentina, Brazil, French Guyana, Paraguay and Uruguay have implemented a complete regulatory framework in accordance with the objectives set in CPB, that is, adequate regulations to ensure protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology. Despite having a complete regulatory framework, French Guyana does not produce or consume GMOs. Furthermore, Bolivia, Chile and Colombia have an incomplete regulatory framework, with only some provisions adopted, but risk assessments and activities with GMOs do take place in these countries, even though Chilean authorizations are exclusive for cultivation followed by re-export purposes. Ecuador, Guyana, Peru and Venezuela have signed and ratified the CPB, but they have either no GMOs authorized or decided to ban them. Finally, in Suriname, a biosafety law has been drafted and it is going to be revised as the country plans to conduct safety assessments in the near future.

    Among the 252 GM crop events approved in South America, 227 are from the main agricultural commodities – maize, soybean and cotton, and most of the traits inserted in those are for herbicide tolerance or insect resistance, either single or stacked (Table 2). The economic benefits of agricultural biotechnology are substantial: from its introduction in 1996 until 2013, the earnings related to this technology have reached almost US$ 25 billion in Brazil and close to US$ 20 billion in Argentina.

    But slowly, new and innovative traits and plants are being developed and are emerging in the biotech scenario in South America. Colombia has approvals for greenhouse cultivation of carnation and rose flowers genetically modified for altered color, exclusive for export purposes. Rice, wheat, sugar beet and flax herbicide tolerant events are also authorized in Colombia for food or feed. The Brazilian research entity Embrapa has developed a viral disease resistant bean with RNA interference (RNAi) mode of action. In this, the plant does not produce a new protein (as in traditional insect resistance or herbicide tolerance traits), but it hinders specific viral infection by activating a defense mechanism from the plant. The same rational was used to develop the genetically modified potato for virus Y resistance in Argentina. And more recently, in 2015, a eucalyptus event with increased wood productivity was approved in Brazil, one great achievement for the continent, as it is the first of its kind and one of the few GM trees approved for cultivation in the world.

    Table 2: Number of biotech events approved (until Dec/2016)**
    Crop
    Brazil
    Argentina
    Paraguay
    Uruguay
    Bolivia
    Colombia
    Chile
    Maize
    38
    42
    14
    10
     
    45
    1
    Soybean
    12
    8
    3
    8
    1
    12
    1
    Cotton
    13
    4
    3
     
     
    12
     
    Bean
    1
     
     
     
     
     
     
    Eucalyptus
    1
     
     
     
     
     
     
    Potato
     
    1
     
     
     
     
     
    Carnation
     
     
     
     
     
    14
     
    Rose
     
     
     
     
     
    2
     
    Rice
     
     
     
     
     
    2
     
    Wheat
     
     
     
     
     
    1
     
    Sugar beet
     
     
     
     
     
    1
     
    Flax
     
     
     
     
     
    1
     
    Canola
     
     
     
     
     
     
    1
    TOTAL
    65
    55
    20
    18
    1
    90
    3
    (**Source: Compilation of approved events made available in databases from ISAAA, BCH, CTNBio and Conabia)

    GMO regulation in Brazil

    Brazil is the second largest biotech crop producer in the world after USA and the first amongst developing countries, presenting a strong, world reference regulatory framework. In Brazil, GMO biosafety is regulated under a specific law (No. 11,105/2005) and several other particular rules, in an attempt to follow up on the incoming necessities as biotechnology researches evolve.

    The National Biosafety Technical Commission (CTNBio, in Portuguese), composed of PhDs in different relevant areas, is responsible to advise the Federal Government in National Biosafety Policy affairs and to provide technical opinion on activities related to all kinds of GMOs, from microorganisms to plants and animals.

    In 2016 alone, CTNBio received 1006 proceedings from applicants – requests for biosafety quality certificates (mandatory for working with GMOs in Brazil), approvals for confined field trials, petitions for the commercial release of new events and other activities. Among them, 740 were granted and others are either in diligence or waiting for CTNBio’s opinion. Also in the last year, 18 GMOs obtained a commercialization approval. Interestingly, only half are crop events; the others are vaccines or microorganisms for industrial enzyme production, a testimony to the valuable potential biotechnology has to different areas, other than agriculture. Among the crops, five maize, one cotton and two soybean events were approved for cultivation and use as food and feed and, for the first time in Brazil, two maize events were approved exclusively for importation and consumption as food and feed, an emergency measure to supply a maize shortage in the country.

    Once an event is commercialized, it may undergo a monitoring period to obtain information on possible unexpected adverse effects resulting from its large-scale use. Firstly, CTNBio must approve the applicant’s post-release monitoring plan, where monitoring length and report periodicity are proposed. The event is monitored until it can be concluded that it poses no greater risks than its conventional counterpart. Alternatively, applicants may request for exemption from monitoring under substantiated grounds. Last year, CTNBio received 24 post-release monitoring reports and 24 new monitoring plans.

    Regardless of the extent of the use of biotechnology in each country, it is fundamental to recognize the importance of GMO regulation to ensure its safety for human and animal health and to the environment, but at the same time, making the best use of this technology for the sustainable development of agriculture, food production and the use of natural resources, as well as for the development of new solutions for health care, pest control, biofuels and industry in general.

    Box – Cartagena Protocol on Biosafety

    The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement that provides an international regulatory framework for the safe application of biotechnology, aiming at extracting the best benefits and reducing any possible risk to the environment and to human health. According to ISAAA (Pocket K No. 8), “when a country signs the Protocol, it signifies its general support for the principles in the Protocol and commits to take the steps necessary to consider and pursue its ratification”. It enters into force only when the country ratifies its signature.

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