Brazil has one of the most effective regulatory frameworks for GMO risk assessment and GMO commercial release. Responsibilities and the pipeline from risk assessment to commercial release are clearly defined, as follows:
a) The technical decision on biological risk is taken by CTNBio, the Brazilian National Biosafety Commission, as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision, based on social-economical reasons and not on biosafety reasons.
b) Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market.
c) In a few cases there are restrictions on areas or regions where the GMO can be used (as for GM cotton) or rules on how to ensure the coexistence of GM and non GM technologies side by side.
d) Every institution) dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO.
The entire system may be accessed at CTNBio internet site (http://www.ctnbio.gov.br/index.php/content/view/12840.html). We suggest a careful analysis of the law and of normative resolution 5. The inspection of Figure 1 below may help understanding the Brazilian biosafety framework.
Figure 1: The Brazilian National biosafety framework. CTNBio – the National Biosafety Commission - has the exclusive role of doing GMO risk assessment, while CNBS – the National Biosafety Council – does the other evaluations needed for risk analysis (social economic issues). The CIBios – Internal Biosafety Commissions supervise every activity dealing with GMOs at the institutional level and the Enforcement and registration agencies (belonging to four different ministries) have the duties to register the new GMO product and supervise their use. The technical decision on biological risks is, therefore, the sole responsibility of CTNBio.
In spite of being a robust system and in the absence of any evidence of negative impacts on environment or on human or animal health derived from any GMO approved by CTNBio and in current use in Brazil, a group of critics still accuse CTNBio of not doing their job right. Irrespective of its motivation, the group concentrates on different issues, depending on the emergence of new publications that would point to “new” risks or support pleas of importance of previously discarded dangers. Such issues keep coming to the media, even if they have been completely surpassed by evidences from good science, as it is the case of Séralini´s paper in rats developing tumors due to the ingestion of transgenic corn (http://genpeace.blogspot.com.br/2012/10/brazil-officially-rejects-seralinis.html). Other issues, like the absurd hypothesis that small RNAs ingested in our food would damage our cells, have also been brought to light recently (http://genpeace.blogspot.com.br/2013/08/basics-on-small-rnas-transgenic-beans.html). Following this trend, and based of very controversial papers, the critics also accuse CTNBio of not using every relevant data (as well as not asking for it during risk assessment appraisal) as, for example, data derived from the “omics”. In spite of being very useful for many science and technology purposes, omics have up to date no use at all in risk assessment (http://genpeace.blogspot.com.br/2013/04/on-omics-for-risk-assessment.html).
A clear statement from CTNBio ensuring people that its work is indeed performed taking into account the internationally established GMO risk assessment procedures and the requirements of the Cartagena Protocol was missing until recently. In the last week an official document from CTNBio´s president Dr. Flávio Finardi was posted in Portuguese and English at CTNBio´s homepage (http://www.ctnbio.gov.br/index.php/content/view/18374.html). It clearly states that CTNBio does it job in strict observance to science and to internationally agreed rules and protocols. We post the whole document, in its version, below, for evaluations by readers.
CTNBio: rigor and transparency on GMO biosafety assessment in Brazil
Flavio Finardi Filho*
Science applied to agriculture has been increasing the food offer for many years, thus reducing the need to find new farming areas. In Brazil, the truth of such statement is proven by the fact that in the past 20 years the production volume increased by over 100%, while the total growing area increased only by 25%. In the period, the Brazilian primary sector became one of the most competitive, innovative agriculture in the world. Together with other methods, biotechnology made management easier and increased productivity. Most Brazilian cotton, maize and soy is genetically modified (GM) and helps the country to strengthen its farming industry.
The transgenic safety assessments follow international standards defined by the World Health Organization (WHO) and by the Food and Agriculture Organization of the United Nations (FAO/UN), institutions that already support GM food, as many others, such as the Pontifical Academy of Sciences. In Brazil, GMOs approved are submitted to toxicological, allergenic, nutritional and environmental testing that go through the National Technical Biosafety Committee (CTNBio), group connected to the Science, Technology and Innovation Ministry (MCTI).
Since 2005, the Biosafety legislation (11.105/05) clearly defines CTNBio is liable for the GMO biosafety technical analysis, under the perspective of the human, vegetable and environmental health. Members from other regulatory agencies, such as the Ministry of Agriculture, Livestock and Supplies (MAPA), the Environmental Ministry (MMA) and the Ministry of Health (MS), participate in the committee, whose decisions are made in a democratic, clear manner, as the meetings are public and the minutes of the meetings are disclosed to the society as a whole. CTNBio’s legitimacy to perform the analyses is based on its members’ scientific excellence. There are 27 full members and 27 deputies, all with doctorate in areas connected to biotechnology. It is essential that any decisions made on the subject are grounded by experts’ analyses, who deeply know how the genes work, the synthesis of proteins codified by such genes and other technical and scientific aspects. The process involves high levels of sophistication and detailing, and the reports issued are not influenced by politics or corporations. It is because of all of these aspects that the Brazilian regulatory system is internationally acknowledged as one of the most stable and rigorous.
The ongoing and precise work performed by the commission enables the country to be the second in the world ranking of the adoption of farming biotechnology and have 37 agronomy transgenic crops approved for consumption and growing. In addition, to cotton, maize and soy, the transgenic beans also stand out, engineered to fend off the golden mosaic virus, the only GM product in the world solely developed by a public research institution – Embrapa. It is also worth mentioning the 17 animal use vaccines and the two yeasts for the production of biofuels. Both have also been assessed and approved.
CTNBio’s greatest challenge is to remain as reference in the quality of the transgenic-related
So that Brazil can still be seen internationally as an important player in the farming segment, as well as farming and livestock research, internal acknowledgement of the importance of the service and the academic community have provided to the country is a must. It is necessary to value the Brazilian research centers, where most scientists, who are part of CTNBio, study, so that the institutions they take part in are still strong, legitimate and, above all, are supported by the society they represent. After all, the crops based on scientific knowledge are essential to the development of sustainable, innovative economy.
*Head of the National Technical Biosafety Committee (CTNBio), PhD in Food Science, professor and researcher at the Food and Experimental Nutrition Department at the São Paulo University (USP) and expert in Food Safety.