Generally speaking, credibility, as it relates to scientific data, can be established via independent replication of study results and ultimately leads to acceptance of the data by other scientific experts. In consideration of newly generated data or the absence of study replication, credibility can be obtained by evaluating and characterizing the data against sets of criteria presented in several excellent publications (Klimisch et al., 1997; Conrad and Becker, 2011; Henry and Conrad, 2008).
In the pesticide industry, data reliability is achieved through the conduct of toxicity studies compliant with testing guidelines and standards endorsed by regulatory agencies. All toxicity testing used to support Bayer CropScience products must adhere to standards of Good Laboratory Practice (GLP; U.S. EPA, 1989; OECD, 1998), as well as to EPA and OECD test guidelines that outline experimental design parameters. GLP regulations also require that regulatory authorities have access to complete study records and data sets, ensuring transparency regarding industry-sponsored testing. Consistently, studies adhering to internationally accepted test guidelines and GLP standards meet the criteria for a high degree of reliability, as defined by Klimisch et al. (1997).
At Bayer CropScience, we strive to rigorously, and with scientific integrity, evaluate the potential toxicity of all of our active ingredients, and isoxaflutole (IFT) is no exception. Although peer-reviewed publications replicating toxicity data on IFT are not available, the most recent human-health risk assessment for IFT by EPA (2011) concludes that the toxicology database is complete and adequate for hazard characterization and human-health risk assessment. All IFT studies considered for risk assessment are EPA and OECD guideline compliant and adhere to the principles of GLP, meeting the reliability criteria outlined by Klimisch et al. (1997). The IFT toxicology database has also undergone thorough review by regulatory agencies around the world and determined to be acceptable. Thus, the credibility and reliability of toxicity studies conducted on IFT are based on adherence to GLP standards and toxicity testing guidelines and documented by the review and acceptance of these studies by independent regulatory authorities.
Conrad, J.W., Jr., and Becker, R.A. (2011). Enhancing credibility of chemical safety studies: Emerging consensus on key assessment criteria. Environ Health Perspect 119:757-764.
Henry, C.J., and Conrad, J.W. Jr. (2008). Scientific and legal perspectives on science generated for regulatory activities. Environ Health Perspect 116:136-141.
Klimisch, H.-J., Andreae, M., and Tillmann, U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg Tox Pharmacol 25:1-5.
OECD (Organization for Economic Cooperation). 1998. OECD Principles of Good Laboratory Practice. Available: http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en.
U.S. EPA. (2011). Isoxaflutole. Section 3 registration for use on soybeans. Human-health risk assessment. Office of Chemical Safety and Pollution Prevention, DP No. D382796. 9 September 2011, 31 p.
U.S. EPA (U.S. Environmental Protection Agency). (1989). FIFRA Good Laboratory Practice Standards. 40 CFR 160. Available: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr160_main_02.tpl.
I’ll try to answer the first part of your question, but obviously, I can’t say anything directly about credibility. As you point out, both Bill Freese and Jack Heinemann are widely cited in anti-GM communications. They hold strongly to certain beliefs that a very large part of the scientific community does not share, but that do resonate within the anti-GM community. Two of these beliefs include that the process involved in modern biotechnology poses unique risks, and that the current regulatory processes used to evaluate risks are unsatisfactory.
The majority of the scientific community – including scientists at leading food safety organizations and regulatory agencies worldwide – disagree with them on both accounts. However, it is because they hold these beliefs and base their writings on them that they are widely cited by the anti-GM websites.
I’d also like to emphasize that safety is a key priority for all of us at Monsanto, and we are committed to hiring and working with world-class scientists and external consultants and cooperators to conduct state-of-the-art experiments that are the basis of the risk assessments in our regulatory submissions. These experiments are conducted using rigorous stewardship and quality control systems to ensure accuracy and reconstructability. Bill Freese does not conduct independent experimental work with GM crops. Rather, his work focuses on policy analysis and public criticism of GM crops. Similarly, while Jack Heinemann has written numerous publications covering a wide range of topics, his anti-GM articles are analyses or editorials that do not involve any original independent experimental data from GM plants.
We respect their right to express their beliefs. We will also continue to candidly answer questions, share information on the safety of our processes and our products and engage with qualified scientific experts around the world to ensure compliance with rigorous regulatory processes.
Moderator: To address the second part of your question, which is about Isoxaflutole and toxicity studies, we are contacting the appropriate expert for view. Thank you for your patience as the GMO Answers Team develops a separate response to address your second question.