Biosafety Data as Confidential Business Information


Kaare Magne Nielsen has published a new article. (Open access)


How do we make safety claims about GMOs more transparent?

Public trust in the food chain relies on transparent regulatory processes, and on independent review of the safety research that regulators rely on. However, confidential business information claims and other limitations to data access keep parts of safety studies informing regulatory decisions hidden from public scrutiny.

A new ‘Perspective’ article published March 5 in the open access journal PLOS Biology by Kaare Magne Nielsen 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 transparency and openness.

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 the food chain. Such CBI claims hinder public review—and scientific exploration—of biosafety issues and knowledge gaps.

In the new article, Prof. Nielsen of the University of Tromsø and Genøk, Tromsø, Norway challenges this current practice of restricted public access to safety data. From the lack of public peer review of CBI-protected or unpublished biosafety data, Nielsen observes that “CBI-protected studies fail to meet most established principles of knowledge production.”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, with several recognized sources of bias.

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 limited disclosure of safety data, to transparency, openness, and adherence to standard principles of knowledge production.”

You can read the entire article here.