The inside story on Monsanto and the glyphosate birth defect data
13th June 2011
The pesticide industry and regulators have repeatedly misled the public with claims that glyphosate is safe, says Claire Robinson. As a result, Monsanto's Roundup is used by gardeners and local authorities, in school grounds, and in farmers' fields
Industry and EU regulators knew as long ago as the 1980s-1990s that Roundup, the world's best selling herbicide, causes birth defects but they failed to inform the public. This is the conclusion of our new report, 'Roundup and birth defects: Is the public being kept in the dark?', authored by a group of international scientists and researchers.
The report reveals that industry's own studies (including one commissioned by Monsanto itself) showed as long ago as the 1980s that Roundup's active ingredient glyphosate causes birth defects in laboratory animals. Industry submitted these studies to the European Commission in support of its application for glyphosate's approval for use in Europe. As the 'rapporteur' member state for glyphosate, liaising between industry and the Commission, Germany took an active role in minimising the problems with glyphosate and must shoulder a chunk of the responsibility for allowing it onto the market.
The facts are these:
*Industry (including Monsanto) has known from its own studies since the 1980s that glyphosate causes malformations in experimental animals at high doses
*Industry has known since 1993 that these effects also occur at lower and mid doses
*The German government has known since at least 1998 that glyphosate causes malformations
*The EU Commission's expert scientific review panel knew in 1999 that glyphosate causes malformations
*The EU Commission has known since 2002 that glyphosate causes malformations. This was the year it signed off on the current approval of glyphosate
But this information was not made public. On the contrary, the pesticide industry and Europe's regulators have jointly misled the public with claims that glyphosate is safe. As a result, Roundup is liberally used by home gardeners and local authorities on roadsides, in school grounds, and other public areas, as well as in farmers' fields.
The latest whitewash attempt by regulators came in the wake of an independent scientific study published last year by Argentine scientists. The study showed that Roundup and glyphosate cause birth defects in frogs and chickens at concentrations much lower than those used in agricultural spraying. The research was prompted by reports of escalating levels of birth defects and cancers in areas of South America where glyphosate is heavily sprayed on genetically modified glyphosate-tolerant crops.
After members of the European Parliament and NGOs raised concerns about the study, the German Federal Office for Consumer Protection and Food Safety, BVL, dismissed it with a claim that the 'huge' database of studies on glyphosate showed 'no evidence of teratogenicity' (ability to cause birth defects). Interestingly, BVL cited as proof of glyphosate's safety the very same industry studies that our report reveals as showing evidence of teratogenicity.
Our report shows how during the EU approval of glyphosate, the rapporteur Germany explained away the birth defects in the industry studies with bizarre excuses. For example, Germany creatively redefined a recognised skeletal malformation found in glyphosate-exposed animals as merely a 'variation'. It repeatedly 'disappeared' findings of birth defects in glyphosate-exposed groups of animals by using historical control data which have a wide variability because the experiments were performed under different conditions instead of the valid control data from the experiment in hand.
Welcome to the Alice-in-Wonderland world of pesticide regulation, where pesticide-induced birth defects are 'variations' and if you don't like the findings of one experiment, you can borrow data from another to make them go away.
The EU Commission's expert review panel followed Germany in dismissing the birth defects, and the Commission signed off on the final approval of glyphosate in 2002.
In response to our report, Monsanto published a statement on its website, claiming, 'Regulatory authorities and independent experts around the world agree that glyphosate does not cause adverse reproductive effects”¦or birth defects.' But this is the nub of the problem. Regulators are 'agreeing' that glyphosate is safe in clear contradiction of the scientific evidence before them.
Monsanto also repeats the usual industry claim that the studies that show problems with glyphosate are 'flawed'. But as our report proves, studies that show glyphosate causes birth defects include industry's own, Monsanto's among them. Is Monsanto saying its own studies are flawed? If so, we have all the more reason to worry, as these are the studies on which the current approval of glyphosate rests.
Commission delays review of glyphosate
A new pesticide regulation comes into force this June. It's more stringent than the existing rules and an objective review of glyphosate under this new regulation may have resulted in a ban. This is partly because under the new regulation, independent (non-industry) studies have to be taken into consideration. Many independent studies, summarised in our report, show that glyphosate and Roundup cause birth defects, cancer, genetic damage, endocrine disruption, and other serious effects, often at low, realistic doses.
Glyphosate was due to be reviewed in 2012. But late last year, after the Argentine study was presented to the EU Commission, the Commission quietly passed a directive delaying the review of glyphosate and 38 other pesticides until 2015.
In 2015, glyphosate will be reviewed under lax, outdated standards. This is because the Commission has failed to complete the data requirements (the tests that industry has to do) for the new regulation in time for industry to do the new tests. Glyphosate will likely sail through its 2015 review and may not be reviewed under up-to-date, more stringent data requirements for another 15 years.
So glyphosate could get a free regulatory ride until 2030, at a time when companies are applying to the EU for permission to cultivate genetically modified glyphosate-tolerant seeds in Europe. This would lead to a huge increase in the use of glyphosate, as has happened in North and South America. The beneficiary of the Commission's delay will be the pesticide industry; the victim will be public health.
We are asking the Commission to cancel the delay and conduct an immediate objective review of glyphosate and Roundup. In the meantime, it must use its powers to withdraw the herbicide from use in Europe.