Questionable Biosafety of GMOs, Double Standards and, Once Again, a "Shooting-the-Messenger" Style Debate

European Network of Scientists for Social and Environmental Responsibility (ENSSER)

Summary and Main Issues

The European Network of Scientists for Social and Environmental Responsibility (ENSSER) welcomes the study "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" of a group of research scientists of the French Committee for Research and Independent Information on Genetic Engineering (CRIIGEN), an institutional member of ENSSER. Séralini et al. (2012) report on a two-year, full life-cycle study with rats testing Monsanto's NK603 glyphosate-tolerant GM maize (single trait glyphosate tolerance) and its Roundup co-technology in the journal Food and Chemical Toxicology.

The group of researchers led by Prof. Séralini has published previous toxicology studies on Roundup and its active ingredient glyphosate (Gasnier et al. 2009; Benachour et al. 2007; Benachour & Séralini 2009). The scientists also evaluated industry data submitted in support of the company’s dossiers seeking approval for food/feed import. When re-analysing the developer’s raw data, they found signs for toxicological effects on rat liver and kidneys after 90 days of feeding with GM maize, including the GM maize NK603 tested in this new study (de Vendômois et al. 2009; Séralini et al. 2007; Séralini et al. 2011).

Repeated calls that regulators should require more rigorous, long-term follow-up studies by the developers have consistently been ignored or rejected. Until 2011, the European Food Safety Authority (EFSA) rejected mandatory 90-day feeding studies as a requirement for applications for GM food and feed (European Food Safety Authority 2011). The few studies that were carried out by developers were voluntary and applied protocols of their choosing.

Main issues

1. CRIIGEN's research^[2] was crucial in finally eliciting a policy response by the European competent authority, the European Commission’s Directorate-General SANCO (Health and Consumer Safety) in 2012. In its draft Implementing Regulation on applications for authorisation of genetically modified food and feed (European Commission 2012), the European Commission stated: "toxicological studies with the whole genetically modified food and feed shall be carried out." If adopted, applicants "shall include a 90-day feeding study with whole food and feed in rodents for the assessment of food and feed containing, consisting of or produced from genetically modified plants [...].."

2. After a comparative analysis of both published industry data and the data of CRIIGEN, ENSSER concludes that many arguments which attempt to invalidate the Séralini et al. study cannot hold up to closer scrutiny. Raised criticisms are to a large extent either wrong or apply double standards. The weak point of the pilot study by Séralini et al. is the number of animals used, which does not allow a statistical analysis of the raw data regarding one parameter measured out of over 30 - mortality. This has been acknowledged by the authors and needs to be considered/remediated in follow-up studies.
   

3. The controversy and vitriolic attacks evoked by the study reveal one underlying aspect: The lack of appropriate and agreed methodologies for long-term studies to scientifically assess the effects of life-time consumption of GM foods.
   

4. The development of such methodology and tests, which have been demanded by concerned scientists ever since GM food was announced to be introduced into international markets, has systematically been blocked by lobby groups of industry and associated scientists. International bodies such as the Codex Alimentarius and national governments - including most EU governments and their authorities - accepted instead the concept of substantial equivalence and the concept of familiarity to evade any scientific mandatory testing of GM food for human health safety. These concepts enable authorities to easily and declare significant differences found between GMOs and their unmodified parents as ‘biologically irrelevant’ in an assumption-based approach without agreed methodology and thresholds.
   

5. The acceptance of these industry-led, constructed models providing the conceptual justification for evading testing of food-related risks associated with the introduction of this new technology and neglecting the clearly formulated demands of European citizens led to the crisis of trust in science and regulations that now come to light with full force.
   

6. Due to the proven close links between industry and EU risk assessors and the documented disproportional influence on regulations by developers and owners of the technology, it is predictable and expected that these authorities, including EFSA, will not be able to substantially revise their original assessment of GM maize NK603 (and any other application) as their credibility is at stake. These on-going conflicts of interests within EFSA have led to the European Parliament (2012) refusing the discharge of the EFSA 2010 budget as long as there is no fundamental change in policy, leadership and guidance.