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How Do We Make Safety Claims About GMOs More Transparent?

in the quality and safety of the food supply has suffered repeated blows in recent years, most recently after food inspectors in Europe found horsemeat in beef products. Restoring public trust in the food supply depends on a transparent regulatory process, and especially on to the research that regulators rely on. But corporate claims of confidentiality often keep the that inform regulatory decisions hidden from public view-inevitably increasing consumer distrust.

A new ‘Perspective’ article published March 5 in the open access journal PLOS Biology argues that consumer confidence is undermined by conflicts of interest that arise at the intersection of environmental, health, and economic interest. These conflicts thrive on a lack of and openness, preventing any opportunities for independent verification and analysis.

Conflicts of interest frequently limit consumers’ ability to understand and verify the safety claims of food products. In the case of genetically modified organisms (GMOs), ‘confidential business information’ (CBI) labels are often placed on documentation regarding the safety of products intended for consumer and animal food markets. Companies often make CBI claims on the grounds that disclosing information could give their business competitors a commercial advantage. This practice not only prevents openness by limiting access to data, but also hinders public review-and scientific exploration-of biosafety issues and knowledge gaps.

In the new article, Prof. of the University of Tromsø in Norway challenges this current practice of restricted public access to safety data with the indiscriminate use of CBI claims. With no internationally agreed standards to determine what constitutes a legitimate CBI claim, the acceptance of such claims is determined by risk managers and lawyers.

“Together, a lack of stringent standards, international harmonization and transparency, along with claims of confidentiality on relevant biosafety data, all generate consumer distrust, hinder public peer review, obscure handling of conflicts of interests, and place additional burdens on regulatory agencies as they must serve as the sole peer reviewers of extensive applications/dossiers,” he writes.

From the lack of public peer review of CBI-protected or unpublished biosafety data, Nielsen observes that “CBI-protected studies fail to meet most established principles of knowledge production.” This observation is particularly troublesome because the safety studies are performed with market-oriented goals, creating various types of bias in the process.

“Consumer distrust is a natural outcome when independent analyses are absent,” says Nielsen. Restoring trust, he adds, requires increased transparency, and openness of documentation, so that we can better understand safety in our food chain.

The article provides a list of recommendations for how to improve data production for regulatory purposes. Nielsen concludes that “change is needed from a culture of secrecy, caused by CBI claims and limited disclosure of proprietary data, to transparency, openness, and adherence to standard principles of knowledge production.”

Making biological material accessible for independent research is essential for both advancing science and building public trust, Nielsen argues. The availability of peer-reviewed studies will help facilitate a more constructive and scholarly discussion of the extensive sets of data routinely collected, and the relevance to potential food safety issues that could arise.

Funding: Funded by the University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: KMN is a member of the GMO panels of the European Food Safety Authority and the Norwegian Scientific Committee for Food Safety. The perspective expressed in this publication is, however, strictly that of the author.


“Biosafety Data as Confidential Business Information”,
Nielsen KM (2013)
PLoS Biol 11(3): e1001499. doi:10.1371/journal.pbio.1001499