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In Argentina and Brazil, existing and planned approvals of GM seeds are under legal challenge.

In Argentina, the legality of the authorisation of Monsanto's new RR2 Intacta soybean has been challenged in court amid reports of a "dodgy dossier" with illegible signatures on approval documents, no independent studies (the latter is usual in the EU and USA but appears not to be so in Argentina), and a missing public consultation and environmental impact assessment.

And in Brazil, the public prosecutor has asked the regulator CTNBio not to approve any new GMOs, including 2,4-D-tolerant corn, until in-depth studies on environmental and health risks have been done. He also wants a broad public discussion with different sectors of society regarding this issue.

1. An environmental NGO objects to a new seed
2. GM: Public prosecutor asks CTNBio to suspend releases
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1. An environmental NGO objects to a new seed
Dario Aranda
Pagina12 (Argentina), 5 Sept 2013
http://www.pagina12.com.ar/diario/sociedad/3-228335-2013-09-05.html
GMWatch/Google translation of Spanish original

The Center for Environmental Legal Studies (Celma) has filed a complaint to the Supreme Court about the "irregular" way in which the new star of agriculture, Monsanto's Roundup Ready 2 Intacta soybean, was approved. Celma argued that there was no approval via public consultation, as is required by Argentine law, and that an environmental impact study had not been performed. The organization questioned the actions of state agencies and said that a large amount of scientific literature on the negative health and environmental effects on health and environment of GMOs had been ignored. The lawsuit seeks annulment of the approval of the soybean and a suspension in the marketing of the seed. The legal complaint explained, as background, how GMOs and pesticides are approved in Argentina. Monsanto defended the approval of the new soybeans.

On August 10 2012, the Ministry of Agriculture signed the resolution 446/12, approving the new generation of soy, called Intacta RR2 Pro. The company advertised it as higher-performing and has already secured the collection of royalties.

On March 19, Celma filed an action before the judge in the Ernesto Marinelli Administrative Court and requested that commercialisation of the soybean be stopped.

Among the first steps, the judge allowed the complainant (Celma) access to the administrative record of the authorisation of the soybean. It consists of almost three thousand pages, with much technical language. After reading the law, the organization concluded that there was no notice of a public hearing (Laws 24,375 and 25,675) for the various sectors of society to learn about the application and express their views, "which nullifies the administrative procedure" that the necessary environmental impact statement had not been carried out by the Conabia (Agricultural Biotechnology Commission) and that the approval "is based on studies only Monsanto". Celma argues that the state has not carried out its own studies.

According to the Center's complaint, on page 2 the studies carried out were detailed. Among others, under the subtitle "Molecular" there were four studies listed, all conducted by Monsanto. On "biological activity" three are listed, also all from the same applicant. The organization believes that the situation is repeated in "nutritional suitability" (one study) and "chronic toxicity" (two studies by Monsanto).

Fernando Cabaleiro, [attorney for] Celma, questioned the role of Conabia and Senasa (Office for Health and Food Quality). "They are based solely and exclusively on studies conducted by the applicant itself, Monsanto. There are no comments or questions about the papers presented by the company," the lawyer said. He noted that on page 37, the decision document in which Conabia approved the new soybean, there were visible "eleven scrawled signatures, without clarifying names, speciality, or position of responsibility. It could be anyone. This is unusual impunity [lack of accountability] with which to give the green light to a seed covering millions of hectares," he said.

Monsanto said in a statement that Intacta RR2 was approved in a manner that "fulfilled every one of the requirements of Resolution 763/11 of the Ministry of Agriculture," which provides for authorization of GMOs. The company supported Conabia and Senasa's action. Monsanto's statement argues that "the rules governing the approval process do not provide for a public hearing" and asserts that "Argentina has a regulatory system consistent with international standards; the underlying principle of the Argentine rules is safety and for such purposes the assessments only allow solid and strict scientific arguments."

GM soya in Argentina covers 20 million hectares (half the cultivated area). It was approved in 1996 by the then Agriculture Secretary Felipe Sola and the authorization dossier was secret until April 2009. Seventeen years after the first GM soy was approved, Cabaleiro commented, "History seems to repeat itself, in that the way this new soybean was approved is very similar to what happened in 1996." He said it is necessary to re-examine all transgenic seeds released in Argentina and demanded that "authorisations must not be kept secret. The process must be transparent and must meet the requirement of citizen participation in order to enable objections to be made, which government agencies today are openly ignoring."
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2. GM: Public prosecutor asks CTNBio to suspend releases
Institution wants conclusive studies on impacts on human health
Estadão Conteúdo
revistagloborural (Brazil), 2 Oct 2013
http://revistagloborural.globo.com/Revista/Common/0,,EMI343414-18078,00-TRANSGENICOS+MINISTERIO+PUBLICO+PEDE+A+CTNBIO+QUE+SUSPENDA+LIBERACOES.html
[GMWatch/Google translation (summarised) of Spanish original]

The office of the public prosecutor has asked the National Technical Commission on Biosafety (CTNBio) to suspend deliberations on the release of transgenic crops resistant to pesticides "until ​​public hearings are held and conclusive studies on the impacts on the environment and human health have been carried out".

The office of the public prosecutor, to justify the initiative, cites information from the Agrobiodiversity Study Group of the Ministry of Agrarian Development, according to which "the release of genetically modified organisms (GMOs) resistant to pesticides will escalate the use of pesticides in Brazil". The argument is that the competitive advantages of transgenic seeds over natural seeds, because of the increased tolerance to herbicides, make them more profitable and preferred by large producers.

The prosecutor Anselmo Henrique Cordeiro Lopes says the issue is complex and the risks need to be discussed with society and academia. In the evaluation of the prosecutor, "The commercial release of these GMOs is acceptable only after a thorough assessment of the direct and indirect impacts that the accumulation of pesticides may cause in the environment and in human consumption."

On the initiative of the prosecutor, the prosecutor's office has launched a civil inquiry into possible illegalities in CTNBio's commercial release of soybeans and corn genetically modified to tolerate the pesticides 2,4-D, glyphosate, glufosinate ammonium DAS-68416-4, glufosinate ammonium DAS-44406-6 and other herbicides. "The files relating to these potential releases were on CTNBio's agenda for September 19, 2013 and have as beneficiaries companies linked to large multinational agrochemical companies, such as Dow AgroSciences, Biotechnology Brazil Ltda., Du Pont Brazil and Monsanto Brazil," says the prosecutor's office.

The prosecutor also requested from CTNBio information about in-depth technical studies "on the cumulative and synergistic effects that the release of these seeds can generate through the escalation in the use of pesticides in monocultures of soybeans and corn in Brazil." The aim of the measure "is to have a more accurate assessment of the possible damage to public health, the quality of Brazilian food, the biodiversity of affected biomes and a balanced and healthy environment."