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Biosafety Data as Confidential Business Information

  • Kaare M. Nielsen mail

    kaare.nielsen@uit.no

    Affiliations: Department of Pharmacy, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway, Genøk-Center for Biosafety, Science Park, Tromsø, Norway

    X
  • Published: March 05, 2013
  • DOI: 10.1371/journal.pbio.1001499

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Biosafety Transparency Not Impacted by Confidential Information

Posted by ericsachs on 27 Mar 2013 at 20:49 GMT

Dear Professor Nielson,

In your recent PLOS Biology article published on March 5th, 2013, you assert that indiscriminant confidential business information claims in data submitted to regulatory authorities unnecessarily limits transparency and public peer review, prevents public disclosure of data needed to establish the safety of GM technologies and withholds biosafety data from public scrutiny and peer review. In addition, you state that government regulatory experts and public sector scientists participating on regulatory expert panels cannot provide adequate assessment of the study design, methods and results included in GM product data packages submitted by applicants and thereby make a quality determination of the food, feed and environmental safety of the GM product. As a remedy, you call for increased transparency, open access to safety-related data and assessments and limited use of CBI claims unless commercially justifiable. The facts do not support your claims and they unnecessarily raise alarm and fuel public fears about the functioning of robust biosafety regulatory systems globally.

Legitimate claims of confidentiality in practice do not apply to biosafety data submitted for review by regulatory authorities. Studies and data submitted to allow for a comprehensive food, feed and environmental safety assessment are fully accessible to competent authorities and non-confidential versions of product applications are available to the public through freedom of information access mechanisms established by applicable law. For example, when an application for GMO authorization is submitted to the European Food Safety Authority (EFSA) via a European Member State and the application is deemed complete, EFSA and the European Commission make non-confidential content available to the public on request, as required under the European legislation for public access (i.e., see Regulations EC No. 1829/2003 and No. 1049/2001). In general, provisions for confidentiality are interpreted by the European Commission in a very strict manner and apply to personal data of involved scientists; DNA sequence information (if not patented); and proprietary protocols which can be claimed confidential. The rest of the application is disclosed to the public. The information disclosed consists of studies developed by the applicants on the characterization of the GM product, on the method used for its development and on its safety towards humans, animals and the environment, as well as relevant publicly available scientific literature. Relevant biosafety data also are made assessable to the public through the public access procedure by regulatory agencies in other countries with established regulatory systems for the assessment of GM product applications. In addition to what is disclosed through the public access procedure, the biotechnology industry also disseminates additional information through publications in scientific journals, participation in conferences, organization of dedicated events, company websites, product guides, etc.

While biosafety information is available, there is a need to balance transparency with the protection of proprietary information and intellectual property. Protection of intellectual property rights as well as data protection is crucial to enable technological innovation intended to address challenges and for the economic growth necessary to meet increasing societal and environmental needs. Industry’s interest in protecting proprietary information is not to shield it from the public but instead to prevent unfair commercial use. Data protection laws recognize the substantial investment industry makes in generating regulatory data, and the inherent unfairness that would result if regulatory data were made freely available for use by competitors. Consequently, we disagree with the author that “most trait- and event-specific data on composition, environmental interactions, allergenicity, toxicity, and other safety aspects are of limited commercial utility.” This information is essential for gaining regulatory authorization of GM products and has enormous value to other commercial interests.

We agree that “making biological material largely inaccessible for independent research is counterproductive both to science and to building public trust as well as further GM market developments.” When the issue of academic research with GM crops was raised in the US in 2009, biotechnology developers came together with the American Seed Trade Association and the Biotechnology Industry Association to listen to public sector concerns and adopted principles and objectives to enable the public sector research community to independently conduct research studies on commercially available seed products (ASTA, 2009). In the spirit of transparency and research freedom, the biotechnology companies provided assurance that the public sector research community is free to design robust, scientifically sound experimental protocols and methodologies and to derive independent conclusions. Since the introduction of GM technologies in the mid-1990s there have been hundreds and hundreds of independently conducted scientific research studies published in the scientific literature, including independent risk assessment to expand the growing body of evidence supporting the safety of GM crops and validate the conclusions of regulatory authorities worldwide.

Academic research on genetically modified crops is beginning to document the beneficial impacts of this technology. In a thorough analysis of GM canola production in Western Canada, it has been concluded that GM canola is the most environmentally sustainable form of crop production currently being utilized, including organics (Smyth et al. 2011a, 2011b). The application of herbicide active ingredient is down by 1.3 million kg compared to what it would have been without the invention and commercialization of GM canola. Farmers, consumers and the environment are all better off from the adoption and substantial production of GM canola. Using the environmental impact quotient and comparing canola production in 1995 (pre-GM) and 2006 (GM), the environmental impact (EI) on farmers has declined by 56%, the EI on consumers has declined by 42% and the EI on the ecology by 54%.

The population of Canada and the US has averaged 300 million following the commercialization of GM crops in 1995. This represents 5.7 billion consumption years of GM foods or food products with GM ingredients, without a single medically document case of concern regarding the safety of GM foods. All of this has been achieved without abandoning the protection of confidential business information.

In the discipline of academic research, a hypothesis is normally proposed, research undertaken that either supports or rejects, said hypothesis. You have hypothesized that claims of CBI make GM crops and foods unsafe for the environment and human consumption, yet you did not provide scientific evidence that proves your hypothesis. While there is ample evidence to the contrary, we offer the environmental results of Hutchison et al. (2010), Kouser and Qaim (2011) and the human health results of Missmer et al. (2006) as examples.

In examining the impacts from the suppression of European corn borer in the US, Hutchinson et al. found that of the US$3.2 billion accrued benefits from Bt corn, 75% or US$2.4 billion have accrued to non-adopters. The adoption of Bt corn has suppressed corn borer populations to such an extent, that damage to neighbouring corn fields, many of which will not be Bt corn, is being strongly observed. Kouser and Qaim identify that the adoption of Bt cotton in India has resulted in a 50% reduction in the application of cotton pesticides. This has reduced the number of accidental pesticide poisonings by an estimated range of 2-9 million individuals. The authors go on to estimate that the savings for the Indian Ministry of Health from not having to treat these millions of cases results in an annual savings of between US$14 and US$51 million.

Missmer et al. identify a reduction in neural tube defects that is attributed to the reduction in the consumption of fumonisins via tortillas. Fumonisins are a form of mycotoxins that can have adverse human health effects (Wu and Munkvold 2008). Bt corn reduces the establishment of mycotoxins and when this corn is consumed as part of a corn-based diet, the health effects can be substantial.

There is overwhelming evidence of the environmental and human health benefits of GM crops. Similarly, the safety of commercialized GM crops has been well established. The European Commission (2010: 16) studied research on the biosafety of GMOs costing more than €300 million and stated, “The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies.”

Consequently, your allegation that CBI claims, limited disclosure of proprietary data and a general lack of transparency regarding biosafety data of GM crops creates a culture of secrecy that limits biosafety data from public scrutiny and peer review is neither true nor supported with evidence in your article. In fact and in practice, there is no relationship between claims of CBI and the environmental or food safety of GM crops.

Respectfully,

Stuart Smyth and Eric Sachs

Stuart Smyth
Research Scientist
Department of Bioresource Policy, Business and Economics
University of Saskatchewan
Canada

Eric S. Sachs
Regulatory Policy and Scientific Affairs
Monsanto Company
USA


References

American Seed Trade Association. 2009. Research with Commercially Available Seed Products. http://www.amseed.com/pdf....

European Commission. 2010. A Decade of EU Funded GMO Research. Brussels: European Commission.

Hutchison, W. D., E. C. Burkness, P. D. Mitchell, R. D. Moon, T. W. Leslie, S. J. Fleischer, M. Abrahamson, K. L. Hamilton, K. L. Steffey, M. E. Gray, R. L. Hellmich, L. V. Kaster, T. E. Hunt, R. J. Wright, K. Pecinovsky, T. L. Rabaey, B. R. Flood and E. S. Raun. 2010. Areawide suppression of European Corn Borer with Bt maize reaps savings to non-Bt maize growers. Science 330: 222-225.

Kouser, S. and M. Qaim. 2011. Impact of Bt cotton on pesticide poisoning in smallholder agriculture: A panel data analysis. Ecological Economics 70: 2105-2113.

Missmer, S. A., L. Suarez, M. Felkner, E. Wang, A. H. Merrill Jr., K. J. Rothman and K. A. Hendricks. 2006. Exposure to fumonisins and the occurrence of neural tube defects along the Texas-Mexico border. Environmental Health Perspectives 114: 2: 237-241.

Smyth, S. J., M. Gusta, K. Belcher, P. W. B. Phillips and D. Castle. 2011a. Changes in herbicide use following the adoption of HR canola in Western Canada. Weed Technology 25: 3: 492-500.

Smyth, S. J., M. Gusta, K. Belcher, P. W. B. Phillips and D. Castle. 2011b. Environmental impacts from herbicide tolerant canola production in Western Canada. Agricultural Systems 104: 403-410.

Wu, F. and G. P. Munkvold. 2008. Mycotoxins in ethanol co-products: Modeling economic impacts on the livestock industry and management strategies. Journal of Agricultural and Food Chemistry 56: 3900-3911.

No competing interests declared.