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Member of Brazil's GMO regulator CTNBio criticizes his own agency for unscientific practices

Below is the second and final part of an interview with the Brazilian agronomist Leonardo Melgarejo, who represents the Ministry of Agrarian Development at the country's GMO scientific advisory agency, CTNBio. Melgarejo looks at several aspects of GMOs and concludes they have changed Brazilian agriculture for the worse.

Melgarejo welcomes the Brazilian government's policy to support agroecological and organic agriculture in response to strong social movements and says it gives reason for optimism for the future. He explains why CTNBio's approach to GMO approvals and monitoring is unscientific. He notes that as more research emerges on the harmful effects of GMOs, GM companies and regulators are heading in the direction of more secrecy. He strongly criticises CTNBio's official dismissal of the Seralini study on GM maize, which over-rode objections from some scientist members of CTNBio.

Part 1 of the interview is here:
http://www.gmwatch.org/index.php?option=com_content&view=article&id=14971
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Transgenics are changing for the worse the Brazilian agricultural reality
Special interview with Leonardo Melgarejo (part 2)
Instituto Humanitas Unisinos (Brazil), Jun 3 2013
Portuguese original: http://www.ihu.unisinos.br/entrevistas/520591-a-transgenia-esta-mudando-para-pior-a-realidade-agricola-brasileira-entrevista-especial-com-leonardo-melgarejo
Google translation into English: http://bit.ly/15HNY1q
GMWatch edit of Google translation below

IHU On-Line - How do you see the National Policy for Agroecology and Organic Production - PNAPO? What limitations will it bring to the expansion of transgenics in the country? How should we understand that, one one hand, the Brazilian State supports such initiatives, but, on the other hand, invests massively in agrotoxics and transgenics?

Leonardo Melgarejo - This is the result of the demands of society, linked to the maturation of perceptions of government. It is true that it is also about something directly associated with the profile of this government, which appears sensitive to social issues, albeit it is heavily influenced by interests that contradict them…

More incisive government action in support of agroecology is an old agenda of civil society and has its root in numerous experiences developed over at least three decades in all regions the country. In fact the government was slow to understand the importance of this demand. And maybe it has only understood it by having been pressured into it, when the subject was marked as non-negotiable priority by the March of Daisies [a march of around 70,000 rural women in support of sustainable development and social justice, which took place in 2011], and by [farmers' union] CONTAG. The entire Brazilian society owes thanks to this action by rural women...

National plan for agroecology and organic production

…The National Plan for agroecology and organic production, which soon will be officially announced, brings good prospects for Brazilian development. It can be stated with emphasis, that the advance is positive, a first step was taken, and it's going in the right direction. In the future, there will be adjustments and the next versions of the plan will surely propose actions more carefully articulated… In order for its actions to actually promote change, the government should be prepared to make space for ongoing dialogue with civil society in all these steps. Observing the results that emerged naturally even in the absence of policies to support agroecology and organic production across the country, I believe we have grounds for a position of optimism about PNAPO.

IHU On-Line - Which GMOs are most challenged in this country?

Leonardo Melgarejo - I believe that the most important cases, in terms of [food] insecurity, at present, concern the fragility of research that sustains information about harmlessness to health and environment. The major problem is the gap between what science allows us to be certain of, and what technology places in the marketplace. There is a big gap between the little that science can say with any certainty and the large amount of products that technology has derived from that science, which are put on the market. The process is almost entirely fuelled by a method of trial and error… and most of the errors are not being questioned.

There are many examples. Consider, as an illustration, that most of the pesticides used on transgenic crops have neurological and hormonal effects. Therefore, CTNBio foresees the need for nutritional studies involving pregnant animals, animals in puberty, menopause, the andropause [hormonal changes in ageing males], animal studies for two generations, to cover these risks and others associated with reduced fertility and emergence of congenital deformations. However, these studies were not presented for any of the GMOs cultivated in the country. Assume further that there is an obvious relationship between the genome and the environment, preventing you from planting apple trees in the Amazon or cupuaçu [rainforest tree] in the Serra Gaucha. So CTNBio requires that studies be undertaken in all national biomes. However, until now such studies were not provided for any of the GMOs released for commercial cultivation in Brazil.

Unforeseen

Consider that, under stress conditions, living beings react in unexpected ways and for the same reason transgenic plants can express unforeseen characteristics under conditions of climate change and biotic and abiotic stress, under conditions to be expected in the real world. However, in applications for commercial release all studies are conducted only under controlled conditions, so that the true test will only occur after commercial cultivation has been permitted. But these facts, which at least indicate the need for periodic re-evaluations, are considered irrelevant. Re-evaluation for GM products does not exist. A product once released is released forever, or - theoretically - until CTNBio decides otherwise.

However, a change in the position of CTNBio does not seem to be something that we can hope for. Consider for example the fact that after publication of a study stating that corn NK603 causes cancer in rats, with or without the application of the herbicide, 14 members and former members of CTNBio requested that attention be given to the problem and recommended re-evaluations of that product. At the same time, five active members of CTNBio requested reconsideration of the decision authorizing its planting under the assumption of no risk, though - at the time of approval - there were contradictory opinions from representatives of the Ministry of Environment, Land Development, and if I am not mistaken, also the Ministry of Health.

More than that, the main social organizations representing consumers and family farmers in Brazil, presented the same request. To all these requests CTNBio said no. Its decision was that corn NK603 does not deserve re-evaluation and that the study of the French scientists, pointing to cancer risks to consumers, should be disregarded. Brazilian scientists who voted for this decision even recommended that the study of the French scientists should be redone. They do not have doubts, they do not question the possibility of progress in the knowledge that supported the previous decisions; they claim that this evidence should be disregarded.

Perhaps this is the most alarming concrete example of the moment. But is not the only one. Another example that causes great concern is the prospect of planting corn and soybean varieties tolerant to the herbicide 2,4-D, under evaluation by CTNBio, which will certainly be released for commercial cultivation as soon as the Commission evaluates them[?]. The decision by a majority of votes can be taken for granted. Another cause for concern is the case of transgenic mosquitoes, which are currently undergoing field testing in some neighborhoods of northeastern towns. Information about GM trees is scarce and there are doubts about the validity of decisions reached concerning stacked-trait products (involving various transgenes). These decisions are made based on studies performed mostly with single-trait GMOs, assuming that the crossings will result only additive effects, yet in nature the whole is greater than the sum of the parts.

IHU On-Line - You attended CTNBio meetings in the past week. Which topics were on the agenda?

Leonardo Melgarejo - In the last meetings several polemical decisions were taken. For example, we discussed the issue of the confidentiality of information that does not relate to genetic constructs, but the agronomic performance of transgenic crops. There is an understanding among most members that even the information about GM crop yields should be kept confidential. Moreover, the understanding is that all information obtained in the tests should be secret. Two years ago this was not so. Between then and now, in the opinion of the minority, the evidence of side effects has grown, and, the same time, the fears of companies have grown over the disclosure of these effects.

Possibly, the marketing campaigns would be harmed by field evidence if it became public knowledge. Thus, some companies ask for secrecy on all or almost all the results of their studies. They claim that the registration of new cultivars will only be possible insofar that all information about these cultivars are secret, unknown, completely unpublished. There are cases where even for studies on GM products already released commercially, there are presented - and approved by the majority - requests for secrecy of items that for a few years were accepted as trivial and did not have any restriction on access. It is surprising that today, with the transparency law in full force, the same type of information receives different treatment.

The theme of monitoring was also discussed. It is known that studies prior to commercial release are carried out in beds and greenhouses under controlled conditions. Thus it is obvious that commercial release brings new risks, associated with planting on a large scale. In this sense, there is a clear need for monitoring. So that monitoring is efficient, the minority understands that simple hypotheses should be evaluated: what kind of problem may occur from planting on a large scale? Under what conditions would it be more likely? In which locations would it be more likely to occur? How would it be perceived? Would it be in its early stages? Who could collect this information and which analyses should be performed?

Monitoring

Basically, the minority want the monitoring to answer simple questions like, "What?" "Where?", "How?", "When?". They aim also to establish a network of observers attentive to these aspects. Now, the majority believes that the proposed monitoring submitted by companies, which is limited to evaluating fluctuations in the effectiveness of the technology, suffice. They essentially propose to put an answering service to clients for collection - by phone - of complaints, to follow technical events, specialized literature and systems for [reporting] health problems, among other things of similarly nonspecific nature. Incidentally, they also propose that questionnaires are sent to a very limited number of farmers, but they do not specify which questions will be asked, how the answers will be analyzed, how the farmers will be selected, how representative the sample will be, etc.

To make the situation even more complex, companies are asking for - and are getting the support of most members of CTNBio - authorization to suspend the monitoring of simple pyramided GMOs containing the same transgene. At the last meeting they approved the replacement of monitoring for maize MIR162 corn with the monitoring of BT11xMIR162xGA21 maize. The dissenting votes argued that "by failing to monitor the single event, the opportunity to identify its specific impact is lost. Eventual identification of problems associated with the pyramided variety will require later studies, to isolate the associated protein damage. This means, from the point of view of MIR162, we will be faced with delaying the identification of causes, as later studies will have to seek information that would be available a priori, by monitoring the MIR162. By accepting replacement, CTNBio is waiving relevant information. The delay in identifying emerging problems may have implications relevant to producers and consumers. The Helicoverpa crisis, with losses that exceed 2 billion Brazilian Real could have been avoided if an effective monitoring program had identified its emergence in the early period."

These arguments were overcome - in the vote - by another, which basically stated the following: the transgene contained in the MIR 162 is also contained in pyramided variety, so just monitor the latter. The obvious fact that the identification of problems in the pyramided variety will require later studies, implying the postponement of corrective measures and losses that monitoring should avoid, was despised.

There is another agenda being crafted by firms with respect to the introduction of new transgenic crops in the market, such as sugarcane, sorghum, orange, and eucalyptus. Currently rules are being created for field testing of these crops, which are necessary steps to commercialization. If we take as examples soybean, corn, and cotton, experience shows that these thousands of experiments performed, especially in the center-south of the country, generated very few data on the potential impacts on the environment and health of these modified plants. Up to now there is no indication that the framework will change for these new species. We regret that the trend will be repeated of generating data of agronomic interest of companies, which however is of little or no use for the analysis of biosafety, which - after all - is the reason for CTNBio's very existence.

IHU On-Line - GMOs are being discussed around the world. How does Brazil fit into this discussion?

Leonardo Melgarejo - There are contradictory approaches. On one side there is unanimity on the importance of scientific and potential of genetic engineering for the future of humanity. On the other hand, there is a great divide on the results obtained to date. Regarding the facts that 99.9% of transgenic products grown worldwide were genetically modified to survive being doused with herbicide, or to produce a toxic protein that is present in all the plant's cells, a division of opinion is justified. It shows that the genetic transformations so far available are not associated with productivity gains, the expansion in the ability to withstand water stress, or modified protein and vitamin content. They are simply about expanding the market and maximizing gains in the disputes of companies that control the market in agrochemicals.

Furthermore, there is a great divide in the world, with regard to the potential risks of this technology. That's because the scientific advances underpinning GM products transgenics are slower than their effective dispersion. Little is known about the risks. There is no monitoring, or at least there is no information about any monitoring of these products, even after fifteen years of commercial release in various locations of the planet. Studies attesting to safety are conducted by the companies or associates. Independent studies which indicate problems are rejected and disqualified and are not repeated by public institutions.

The EU avoids the commercial planting of GM crops, but allows their import. It does this because the main exporters do not have sufficient supply of non-GM grains. Why not? Because the same companies that control the pesticides control the seeds, while small distributors and alternative seeds are disappearing from the market. In addition, throughout the whole world, the seed that is controlled by farmers is being contaminated. The lack of independent supply chains segregating GM crops from non-GM crops makes this inevitable. Huge oligopolies and links that are not well explained between regulatory bodies and the streamlining of decisions for commercial release, coupled with policies that facilitate the expansion of transgenics and restrict alternative possibilities, are the foundation of this reality. This is evidence that although this issue is treated as a technical one, it is essentially economic and responds only to political decisions...

There is still another perspective, which is discussed on a global scale. That is, what is at stake is life itself. It is from this perspective that the seeds are the patrimony of humanity; they cannot be patented because this requires accepting that life can be treated as a commodity. There are also other issues and focuses in the discussion. For example, the question of the fragility of the evaluation procedures, the need for labelling, traceability and monitoring of consumption. There are also difficulties relating to the liability and indemnification for losses, and the measuring of impacts on the environment and health, among others. How does Brazil fit into these issues? As a subordinate. One of the arguments most often presented by the majority in CTNBio is: this product has already been released in the US, or Argentina, or Canada, or in all of them.

IHU On-Line - Do you want to add anything?

Leonardo Melgarejo - On the subject of GMOs, I can only reiterate what has been said in the minority CTNBio: that the evidence is contrary to the optimistic expectations associated with the expansion of transgenic products. But even so, we hope, in the interests of all, that the majority, who fear nothing, and who completely trust this technology, are right. It is in the very great interest of the majority, considering the mechanisms in operation, that we, the minority who insist on the precautionary principle, are wrong. Therefore, in this dispute and in these circumstances, we root for them, we cheer for our opponents.

I want to add other information. Last week I was at the 6th State Seminar on Agroecology, which gathered over 2.5 thousand people in Pinhalzinho, in the far west of Santa Catarina. People from more than 220 municipalities in various regions of Santa Catarina and other states, traveled at their own expense to discuss agroecology. That alone reveals the importance of the event, which at its conclusion reaffirmed a common goal: "to build and foster a system of sustainable agriculture for the whole human community based on the principles of agroecology." This is not a small thing: conferences about transgenics are subsidized, participants receive daily freebies and mostly, participation is restricted.

At the seminar in Santa Catarina, participants wrote a document conclusive which points out the importance of public subsidies for expansion of agroecological production, directed to farmers in transition, where the goal would be to move away from agrochemical production. They also denounced the use of science and politics in the service of private interests that undermine biodiversity on the planet, noting that the standards and practices of CTNBio are vulnerable to commercial interests, threatening biosecurity and the precautionary principle.

Finally, on the issue of inclusion of genetically modified seeds in the Troca-Troca program [a seed exchange program], they say: "We reject the subsidy for the purchase of GM seeds through public programs such as the Troca-Troca program of the government of the state of Santa Catarina" and ask for "incorporation of agroecological and native seedlings and seeds into the seed exchange programs and the distribution of seeds". I agree with farmers of Santa Catarina. I realise that they are more advanced that we are, in this dispute which is in everyone's interest. In fact, we have much to learn from them.