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Genetically modified organisms (GMOs) and their application in Brazilian agriculture and consumer products
Lefosse Advogados, São Paulo
Natássia Misae Ueno
Lefosse Advogados, São Paulo
In recent decades, genetically modified organisms (GMOs) have been a constant topic of discussion by civil society, scientists and international bodies. Despite their current large-scale use in agriculture and, consequently, in the production of food and food ingredients for both animal and human consumption, the use of GMOs in the food industry causes controversies about their safety to the environment and to human and animal health, as well as highlighting sensitive points regarding the duty of information to consumers and right to informed choice. In this regard, Brazilian law converges with the European Community legislation on the subject, prioritising the principles of precaution and information and the traceability of GMOs in food products.
Background of GMO regulation in Brazil
The first Brazilian legal standard on GMOs was enacted in 1995, just a year after the first genetic modified food was made available to the consumer market – the ‘Flavr Sarv tomato’, with greater durability, produced in California. Law No. 8,974/1995 created the National Technical Commission on Biosafety (CTNBio), a commission linked to the Ministry of Science and Technology, and provided for the procedures applicable to the approval of GMOs.
Despite the relevance of this regulation to the Brazilian industry, due to conflicts with environmental and biosafety standards arising from the Roundup Ready Soybean case in 1998, in late 2003, the Federal Government proposed a Bill of Law to Congress to replace it, which later became the new Brazilian legal standard on biosafety (Law No. 11,105/2005, regulated by Decree No. 5,591/2005). The new law restructured the CTNBio, created the National Council of Biosafety (CNBS) and implemented the National Policy of Biosafety (PNB).
In parallel, the Federal Government enacted Decree No. 4,680/2003, regulating the consumer right to information in Section 2. This provided that the consumer must be informed of the transgenic nature of food and food ingredients intended for human or animal consumption that contain, or are produced from, GMOs, with a presence of over one per cent of the product..
Twenty eight years after Law No. 8,974/1995 was enacted, Brazil has 112 genetic modified crops approved, among crops of bean, cotton, eucalyptus, maize, soybean, sugarcane and one crop of wheat, and the country has been considered one of the largest producers of genetic modified crops in the world.
Brazilian legal and regulatory framework regarding GMOs
In addition to the legal standards mentioned above (Law No. 11,105/2005 and Decrees No. 5,591/2005 and No. 4,680/2003), Brazilian regulation on GMOs is mainly based on the infra-legal rules issued by the CTNBio, especially Resolutions RN 37/2022, 32/2021, 35/2021, 18/2018, 6/2008, among others. Moreover, some international forums and agreements have direct influence on how the GMO issues are regulated domestically, such as Cartagena Protocol on Biosafety and the Codex Alimentarius standards.
These regulations created a robust system of biosafety and surveillance mechanisms that intend to: (i) protect human, animal and plant life and health; (ii) incentivise scientific advance; and (iii) protect the environment.
When it comes to GMOs in Brazil, CNBS and CTNBio are the two public bodies responsible for issuing regulation and approving new activities involving GMOs:
- CNBS is composed of eleven State Ministers and is linked to the presidency, playing the role of top advisor to the president for the development and implementation of the National Policy of Biosafety (PNB). In addition, the CNBS functions as a court of appeals for the authorisation of GMOs and their by-products for commercial use, deciding upon third party requests or ex officio.
- CTNBio is an advisory and deliberative multidisciplinary collegiate body, which provides technical support and advice to the federal government in the implementation of the PNB, as well as in the establishment of technical safety standards. Also, it is the body responsible for authorising activities involving research and commercial use of GMOs and their by-products, based on the assessment of their zoophytosanitary, human health and environmental risk.
In order to approve a new research with, or the commercial use of GMOs and their by-products, the applicant must hold a Biosafety Quality Assurance Certificate (CQB – certification granted by CTNBio for legal entities that intend to develop activities with GMOs and their by-products), set up an Internal Biosafety Commission (CIBio) which is responsible for assessing the biosafety of GMO- and monitoring-related activities and appoint a technical officer.
It should be noted that any legal entity, national or foreign, that finances activities or projects involving GMOs and their by-products shall require the presentation of the CQB, under the penalty of being considered jointly liable for damages arising from the non-compliance with applicable regulations.
Besides the general rules described above, there are specific procedures for approving research (in the field or in facilities) and commercial use of GMOs, which may differ depending on the risk class in which the GMO and/or its by-product are classified. The risk class shall be defined by CIBio prior to requesting authorisation before CTNBio.
Following authorisation by the CTNBio, or by the CNBS depending on the case, the Ministry of Agriculture, Livestock and Supply (MAPA), the National Health Surveillance Agency (ANVISA) and the Ministry of the Environment (MMA) will be responsible for registering and surveilling products manufactured using GMOs and their by-products and/or activities involving GMOs, within their respective fields of activity.
Most current legal discussions involving the use and application of GMOs
Even though GMOs have been used in agriculture for almost 30 years now, there is still some resistance and controversy from civil society. While the advances in biotechnology open up new perspectives for solving problems in areas such as agriculture, the release of transgenics in the environment brings new approaches to studies regarding possible problems of an ecological nature and for human and animal health. That is why they continue to divide opinions among experts all over the world, which is no different in Brazil.
- Discussions within the legislative and judiciary branches
In recent years, the House of Representatives intended to establish the obligation to inform the consumer about the presence of GMO components in the food products by proposing the Bill of Law No. 34/2015 (also called as PLC No. 4148/2008).
The Bill of Law intends to establish the need for information on the presence of GMOs in food (where it comprises over one per cent of the product) and to impose the criteria of detectability instead of traceability. The presence of GMOs in the food product shall only be considered if such presence is demonstrably detected in the final composition of the product.
Furthermore, the Bill of Law intends to exclude the following information from the label: (i) the gene donor species; (ii) the symbol indicating the presence of a GMO (a triangle with the letter ‘T’ in the middle); and (iii) the labelling of foods and ingredients produced from animals given feed containing transgenic ingredients.
Since December 2022, the Bill of Law had been shelved due to the end of the legislature, however its reopening was requested on March 2023 and it is pending inclusion on the Senate agenda (RQS 264/2003).
While the subject remains pending in the legislative branch, since then, several topics related to the approval and use of GMOs have been challenged within the judiciary, where numerous actions, measures and incidents are filed to discuss aspects related to the theme.
The Superior Court of Justice (STJ) are currently processing punctual actions, involving the most diverse subjects from the competence to rule out complaints against those accused of committing the crime of illegally releasing GMOs into the environment (State Justice v Federal Court) to the lack of documents for approval of research and activities involving GMOs.
At the scope of the Federal Supreme Court (STF), the most relevant discussions involve two main topics: (i) the competence of CTNBio to approve the release of GMOs; and (ii) the rules for labeling products that contain the presence of GMOs in their formulations (notably those related to the obligation of information to the consumer by the manufacturers linked to the limit of one per cent according to the Decree No. 4,680/2003).
These topics are not handled homogeneously by the court. Although the STF has already decided that there must be full disclosure of the presence of GMOs at any level, a variety of actions have been brought to challenge local state legislation that imposes the said full duty to inform. In many of these actions, the Plenary of the STF has been defending the constitutionality of the duty to inform the presence of GMOs in the product only if represents one per cent or more of its formulation, reinforcing the prevalence of the Decree No. 4,680/2003.
- Authorisation for cultivating and commercialising the Wheat HB4
A relevant and recent event in Brazil refers to the transgenic wheat. Until 2021, CTNBio had not authorised the commercial use of any species of transgenic wheat for any purpose. However, this scenario changed in November 2021, when CTNBio approved the commercialisation of drought resistant genetically modified wheat flour (event IND-ØØØ412-7 or ‘Wheat HB4’) for import and exclusive use in food, feed or derived products (for human and animal consumption) as requested by its Brazilian applicant.
Soon after the authorisation for import, the applicant requested and received authorisation for wide use (cultivation, production, manipulation, transport, transfer, commercialisation, import, export, storage, release and disposal) of the Wheat HB4.
Both events caused great controversy, including from civil society organisations who said that consumer rights are being disrespected and that OGM products may cause serious and unknown harm to human and animal health. It was widely publicised that such organisations plead for the CTNBio’s Wheat HB4 authorisation to be cancelled, under the argument that the approval process would not have observed the adequate technical safety studies and the necessary public discussions.
The topic remains controversial and creates different opinions among the industry sector and society, not only with regard to risks and issues, but also with regard to the consumer’s right to information. This is yet another chapter, which will now also have to be followed in the discussions on the future of GMOs in Brazil.
 Food and Agriculture Organization of the United Nations – FAO. Genetically modified organisms, consumers, food safety and the environment. FAO Ethics Series, vol. 2, Rome: 2001.
 Legal Framework on Genetic Modified Organisms / Ministry of Health, Pan-American Organization of Health – Brasília: 2010.
 According to International Service for the Acquisition of Agri-biotech Applications (ISAAA). Source: www.isaaa.org/gmapprovaldatabase/advsearch/default.asp?CropID=Any&TraitTypeID=Any&DeveloperID=Any&CountryID=BR&ApprovalTypeID=Any. Accessed 20 April 2023.
 According to the National Society of Agriculture (SNA), Brazil figured as the second largest transgenic-planted country in the world in 2019. Source: SNA, EUA e Brasil continuam a liderar a produção de transgênicos no mundo. 2020. www.sna.agr.br/eua-e-brasil-continuam-a-liderar-a-producao-de-transgenicos-no-mundo. Accessed 20 April 2023.
 Provides for the installation and operation of the Internal Biosafety Commissions (CIBios) and the criteria and procedures for requesting, issuing, revising, extending, suspending and cancelling the Biosafety Quality Assurance Certificate (CQB).
 Provides for rules for the commercial release and monitoring of genetically modified animals and plants and their derivatives of plant and animal origin.
 Provides for the granting of authorisation by CIBio for the planned release into the environment of GMO and its risk class one derivatives.
 Provides for the classification of risks of GMOs and the levels of biosafety to be applied in activities and projects with GMOs and their derivatives in containment.
 Provides for the rules for the planned release into the environment of plant-based GMOs and their derivatives.
 Commercial use encompasses the cultivation, production, handling, transport, transfer, commercialisation, import, export, storage, consumption, release and disposal of GMOs for commercial purposes.
 Resolutions RN 18/2018, 37/2022, 6/2008 and 35/2021.
 Resolution RN 32/2021.
 Resolution RN 18/2018.
 STF, Constitutional Complaint No. 14.873/BA within the Class Action No. 2001.34.00.022280-6/DF, Rapporteur minister Edson Fachin, judged in 05/05/2016.
 According to Technical Opinion 7795/2021 of 16 November 2021.
 Developed by Bioceres Crop Solutions.
 Tropical Melhoramento e Genética S.A.
 According to Technical Opinion 8407/2023 of 6 March 2023.