Approvals violate the precautionary principle, says prosecutor

Brazil's federal public prosecutor has filed a public civil action requiring the suspension of commercial release of three GM maize seed varieties: Monsanto's MON87411 and MON87460; and Syngenta's 3272.

The lawsuit cites several problems with the authorisations, including the lack of studies showing that these GMOs are safe to eat and for the environment. According to the four prosecutors who signed the document, the commercial release of the three GM seed varieties, put into effect by the Brazilian GMO regulator, the National Technical Biosafety Commission (CTNBio), “directly violates the principles of prevention and precaution, exposing the environment and public health to serious risks”.

The lawsuit also demands a ban on the import of seeds of these GM maize varieties from countries that are not signatories to the Convention on Biological Diversity's Cartagena Protocol, which aims to ensure the safe transport and use of GMOs. Brazil is a signatory, whereas the US, which grows all these maize varities, is not.

One of the maize varieties named by the public prosecutor is authorized for food and feed use in Europe and a second has received a positive opinion from EFSA, which generally paves the way to an authorization by the European Commission.

The objective of the Brazilian judicial process is that CTNBio is ordered to annul the commercial releases of these products and to cease authorising the import of the seeds.

The lawsuit points to shortcomings in the administrative processes that authorised the commercialisation of the GM seeds and adds that those shortcomings render the authorisations void. All three GM maize varieties were processed on an emergency basis on the request of the Brazilian Animal Protein Association, based on the claimed risk of a shortage of maize for animal feed in the domestic market. This argument was used repeatedly in the discussions of the CTNBio meetings in September and October 2016, when the three maize varieties were released for commercialisation, despite news reports of an excellent maize harvest in Brazil.

Precautionary principle violated

The public prosecutor’s lawsuit raises several points that demonstrate the shortcomings of the authorisation processes: the lack of specific studies on Brazilian biomes, as required by national law; methodological deficiencies in the technical opinions of CTNBio and in the studies that supported them, which were financed by the private companies with an interest in commercialisation; unproven seed productivity advantage; failures in studies relating to the proteins in the plants and consumer safety; lack of bibliographic references and methodology to identify adverse effects on human and animal health; and lack of toxicity and immunological studies, among other issues.

In case of non-compliance with the preliminary injunction or any final court ruling, the lawsuit requires the payment of a daily fine to the amount of 5,000 Brazilian Real (1,239 USD).

Where are these GM maize varieties used?

The three GM maize varieties were approved in Brazil in 2016 and have since been used in animal feed and human food. Europeans are eating meat from animals fed with these GMOs.

MON87460 is authorised for food and feed in the EU and Brazil, and for those uses plus cultivation in the US and Canada. MON87411 is authorised for food, feed, and cultivation in Brazil, the US, and Canada. In Europe EFSA has given a positive opinion for import for food and feed uses but the maize has not been approved for cultivation. 3272 is authorised for food and feed in Brazil, and for those uses plus cultivation in the US and Canada. It is not authorised for food and feed (or cultivation) in Europe as EFSA refused to give a positive opinion on it due to a lack of data. 

MON87460: CTNBio member warns on safety, allergenicity

Regarding MON87460, Dr Karen Friedrich, a member of CTNBio, raised a number of objections. She stated that the studies presented to the Brazilian regulator showed a change in the nutritional composition of MON87460 when compared to conventional maize; that little information was given by the applicant on the safety of this GMO; that the required studies on the teratogenic potential and immunological and histological analyses were not presented; and that subacute (28 days) and subchronic (90 days) toxicity studies were not presented.

Dr Friedrich stated that there was a potential for allergenicity, based on recent studies. She added that some aspects of Brazilian law were not complied with in the application dossier.

EU member states warn on antibiotic marker genes

Problems were found with MON87460 not just by CTNBio members, but also by European member states during the EU authorisation process. MON87460 contains the aadA gene, which contains genes for resistance to the antibiotics spectinomycin and streptomycin. EU law dating back to 2001 has required that these genes be phased out of GMO crop development as a precautionary measure, in case they contribute to the huge problem of antibiotic resistance. Austria stated, "The decision of the notifier to avoid the removal of the antibiotic resistance marker gene from the adult plant genome is disconcerting." Denmark expressed the same concern.

France said that one of the newly expressed proteins was fed to rats in too low a dose to give meaningful information on the food safety of the maize and that a new study with a higher dose should be submitted. France added that its food safety agency "is unable to reach a decision on the safety of... MON87460, of its grain and of products derived from it".

Austria commented that the safety for consumption of the newly expressed proteins in MON87460 is not demonstrated in the industry application dossier. Notably, there were marked differences in body weight between mice fed the GM maize and controls, albeit they were not statistically significant. The German research NGO Testbiotech remarked on the "high level of uncertainty" in the dossier and found EFSA's risk assessment inadequate.

Shambolic GMO regulation

The public prosecutor’s lawsuit exposes the shambolic state of GMO regulations and their implementation, not only in Brazil, but in Europe and worldwide. Required biosafety data are missing, unexpected changes in composition in the GMO are glossed over, and worrying health impacts in animal feeding studies are ignored. In the EU, legislation specifically requiring antibiotic marker genes to be phased out is cast aside. It is no surprise that public confidence in the safety and desirability of the GM food venture remains low.

Report: Claire Robinson