Dear
readers.
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.
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