Changes brought on by the dynamic nature of science, emerging technologies, and risk analysis keep scientists engaged. But sometimes they bring controversy. Case in point: Several papers published in Environmental Health Perspectives and Nature (Becker et al., 2009, 2010; Lorentzen and Hattan, 2010; Myers et al., 2009a,b; Tweedale, 2010; Tyl, 2010; and Vom Saal and Myers, 2010) by scientists in the research and regulatory communities contrasted Good Laboratory Practices (GLP, 21 CFR Part 58) guideline-based toxicological studies to hypothesis-based studies in the U.S. Food and Drug Administration’s (FDA) evaluation of the human health risk of bisphenol-A (BPA).
In 2009, the Bipartisan Policy Center (BPC—a nonprofit organization established in 2007 by former U.S. Senators) published “Improving the Use of Science in Regulatory Policy.” The report, produced by a diverse panel of scientists and policy experts, called for greater transparency in the evaluation of science (BPC, 2009). And last year, the FDA launched its Advancing Regulatory Science initiative (FDA, 2010), recognizing the importance of new scientific tools and technologies in advancing public health and the need for modern approaches for evaluating and approving them.
With these activities as a backdrop, the Pew Health Group of The Pew Charitable Trusts organized a workshop to bring together key stakeholders with diverse perspectives to discuss the issues raised in these publications and other hot topics. The workshop was not intended to achieve consensus on any matters, but to develop a more common understanding of the subjects and identify options for potentially enhancing assessment of the safety of chemicals added to food.
IFT is an advocate for food science and a catalyst for change around the world. We are committed to advancing the science pertaining to the safety and wholesomeness of the global food supply. Thus, we were pleased to join with Pew as a workshop cosponsor, along with the journal Nature, and to work with representatives of FDA and the National Institute of Environmental Health Sciences, to plan the workshop. Entitled “Enhancing FDA’s Evaluation of Science to Ensure Chemicals Added to Human Food are Safe,” the workshop took place April 5–6 at The Pew Charitable Trusts’ Conference Center in Washington, D.C.
Participants heard valuable insight and perspective from several speakers. Mitchell Cheeseman, Acting Director of the FDA’s Office of Food Additive Safety, reviewed the agency’s safety assessment process and use of computational toxicology. Jean-Lou Dorne of the European Food Safety Authority (EFSA) and Angelika Tritscher of the World Health Organization (WHO) provided brief remarks on the testing and risk assessment guidance and pertinent work of the EFSA, Joint Food and Agriculture Organization of the United Nations/WHO’s Expert Committee on Food Additives, and Organization for Economic Cooperation and Development. Rodger Curren of the Institute for In Vitro Sciences, Leon Bruner of the Grocery Manufacturers Assoc., Jennifer Sass of the Natural Resources Defense Council, and Raymond Tice of the National Toxicology Program/National Institute of Environmental Health Sciences spoke about alternative toxicology methods.
One area of deliberation focused on identifying and validating testing endpoints, including adverse effects and whether endpoints relating to endocrine disruption and adverse behavioral impacts could be measured in guideline-based toxicity studies. Another area of discussion focused on physical and chemical properties appropriate for nanomaterial characterization, and whether current methodologies are adequate for characterization. Other topics included the roles of the Tox21 in vitro hazard-screening studies and National Health and Nutrition Examination Survey biomonitoring exposure studies in safety assessments; the utility and updating of toxicological research guidelines; improving research reproducibility and transparency; and improving guideline- and hypothesis-based research to ultimately refine regulatory decision making processes.
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Through this workshop, we sought to move beyond specific controversies and to take a closer look at the entire food-related hazard characterization and safety assessment system. Furthermore, Pew’s Food Additives Project has several activities underway to comprehensively assess the existing U.S. regulatory system for determining that food additives are safe, as required by law. A summary of the recently concluded workshop is expected to be published in a peer-reviewed journal. So, please stay tuned for more on food additives.
Rosetta Newsome, Ph.D., is Director, Science and Policy Initiatives, Institute of Food Technologists ([email protected]).
Becker, R.A., Janus, E.R., White, R.D., Kruszewski, F.H., and Brackett, R.E. 2009. Good laboratory practices and safety assessments. Environ. Health Persp. 117(11): A482-483.
Becker, R.A., Janus E.R., White, R.D., Kruszewski, F.H., and Brackett, R.E. 2010. Good laboratory practices: Becker et al. Respond. Environ. Health Persp. 118(5):A 194-195.
BPC. 2009. Improving the Use of Science in Regulatory Policy. Science for Policy Project. Final Report. August, 5. Bipartisan Policy Center. Available at: http://www.bipartisanpolicy.org/sites/default/files/BPC%20Science%20Report%20fnl.pdf. Accessed on Mar. 4, 2011.
FDA. 2010. Advancing Regulatory Science for Public Health. A Framework for FDA’s Regulatory Science Initiative. October. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm. Accessed on Mar. 5, 2011.
Lorentzen, R.J. and Hattan, D.G. 2010. Response to Nature editorial. Available at: http://www.nature.com/nature/journal/v464/n7292/full/4641103b.html#comment-12729. Accessed on Mar. 8, 2011.
Myers, J.P., vom Saal, F.S., Akingbemi, B.T., Arizono, K., Belcher, S., Colborn, T., Chahoud, I., Crain, D.A., Farabollini, F., Guillette Jr., L.J., Hassold, T., Ho, S-M., Hunt, P.A., Iguchi, T., Jobling, S.,
Kanno, J., Laufer, H., Marcus, M., McLachlan, J.A., Nadal, A., Oehlmann, J., Olea, N., Palanza, P., Parmigiani, S., Rubin, B.S., Schoenfelder, G., Sonnenschein, C., Soto, A.M., Talsness, C.E.,
Taylor, J.A., Vandenberg, L.N., Vandenbergh, J.G., Vogel, S., Watson, C.S., Welshons, W.V., and Zoeller, R.T. 2009a. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environ. Health Persp. 117(3): 309-315.
Myers, J.P., vom Saal, F.S., Taylor, J.A., Akingbemi, B.T., Arizono, K., Belcher, s., Colborn, T., and Chahoud, I. 2009b. Good laboratory practices: Myers et al. respond. Environ. Health Persp. 117(11):A483-484.
Tweedale, T. 2010. Good laboratory practices and safety assessments: Another view. Environ. Health Persp. 118(5):A194.
Tyl, R.W. 2010. Good laboratory practices: Tyl responds. Environ. Health Persp. 118(2): A60-61.
vom Saal, F.S., Myers, P. 2010. Good laboratory practices are not synonymous with good scientific practices, accurate reporting, or valid data. Environ. Health Persp. 118(2): A60.