THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
A recent article published in PLOS Biology Journal examines the problems with the current practices and the indiscriminate uses of confidential business information (CBI) claims in biosafety assessments.
CBI was a contentious issue during the Cartagena Protocol negotiations and the Protocol specifies that an applicant may claim some information confidential, with justification, and it is for the Party to decide which information should remain confidential vis a vis the public. Importantly, the Protocol does not specify which information should be kept confidential, rather it specifies which information should never be kept confidential, leaving the scope of and decision on confidential information to national laws and regulations.
This article reaffirms the need for national regulations to not classify information needed for biosafety assessment and public accountability. Such information is needed to enable independent research and monitoring, public peer review, improvement of the risk assessment process and avoid conflicts of interests, among other reasons.
The author notes that “although some regulatory systems explicitly prohibit CBI claims on biosafety studies, company practices may still make such studies unavailable to the wider public. In summary, he concludes that “Data production for regulatory purposes remains stuck in a closed frame, against the trend of openness in data access and sharing emerging in other scientific fields. 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.”
We reproduce the abstract below. The full article is available at
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Biosafety Data as Confidential Business Information
Kaare M. Nielsen
Citation: Nielsen KM (2013) Biosafety Data as Confidential Business Information. PLoS Biol 11(3): e1001499. doi:10.1371/journal.pbio.1001499
Confidential business information (CBI) is a necessary tool to protect commercial interests in the rapidly developing field of gene technology. CBI is also often claimed for documentation and materials supporting the biosafety assessments of genetically modified organisms (GMOs) intended for environmental release, food, and feed use. However, such claims oftentimes marginally serve their legitimate purpose to protect commercial interests and unnecessarily limit transparency and public peer review of data submitted to regulatory authorities. CBI and proprietary claims also restrict access to transgene sequence data, transgenic seeds, and other GMO materials, which precludes the development of independent research and monitoring strategies. In the long run, such claims are counterproductive to the safe and responsible commercial development of GM technology as they hinder the accumulation of biosafety data in the open, peer-reviewed literature, which is needed for both public and scientific consensus-building on safety issues and for improvements to the risk-assessment procedure itself. The increasing recognition of conflicts of interest as an invariable part of market-oriented safety-data production, interpretation, and risk communication also calls for transparency and open access to safety-related data and assessments.