Advanced biological information such as computational biology, in vitro transformation assays, genome pathway analysis, genotoxicity assays, proteomics, gene expression, cell signaling disruption and hormone receptors offer the poten- tial for significant improvements in the ability of regulatory agencies to consider the risks of the thousands of compounds—and mixtures of compounds—currently unexamined. While the science for performing the assays underlying such information is developing rapidly, there is significantly less understanding of the rationality of using these data in specific decision problems. This paper explores these issues of rationality, identifying the issues of rationality that remain to be developed for applications in regulatory risk assessment, and providing a draft decision framework for these applications. The conclusion is that these rapid, high throughput methods hold the potential to significantly improve the protection of public health through better understanding of risks from compounds and mixtures, but incorporating them into existing risk assessment methodologies requires improvements in understanding the reliability and rates of Type I and Type II errors for specific applications.
Cite this paper
D. Crawford-Brown, "The Role of Advanced Biological Data in the Rationality of Risk-Based Regulatory Decisions," Journal of Environmental Protection, Vol. 4 No. 3, 2013, pp. 238-249. doi: 10.4236/jep.2013.43028.
 National Research Council, “Science and Decisions: Advancing Risk Assessment,” National Academy Press, Washington DC, 2009.
 D. Crawford-Brown, “The Precautionary Principle in Environmental Regulations for Drinking Water,” Environ- mental Science and Policy, Vol. 14, No. 4, 2011, pp. 379- 387. doi:10.1016/j.envsci.2011.02.002
 European Commission, “Communication from the Commission on the Precautionary Principle,” COM(2000)1, Brussels, 2 February 2000.
 CFR, “Protection of Environment, CFR Parts 1-49, Code for Federal Regulations,” US Environmental Protection Agency, Washington DC, 2003.
 European Parliament, “Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),” 2006.
 US Senate, “Reauthorization of the Toxic Substances Control Act: Hearings before the Subcommittee on Toxic Substances, Research, and Development of the Commit- tee on Environment and Public Works,” United States Senate, One Hundred Third Congress, Second Session, May 1 2011.
 D. Crawford-Brown, “Risk-Based Environmental Decisions: Methods and Culture,” Kluwer Academic Publishers, Norwell, 1999. doi:10.1007/978-1-4615-5227-7
 M. Dourson, S. Felter and D. Robinson, “Evolution of Science-Based Uncertainty Factors in Noncancer Risk Assessment,” Regulatory Toxicology and Pharmacology, Vol. 24, No. 2, 1996, pp. 108-120.
 D. Crawford-Brown, “Mathematical Methods of Environmental Risk Modeling,” Kluwer Academic Publishers, Norwell, 2001. doi:10.1007/978-1-4757-3271-9
 S. Moolgavkar, “The Multistage Theory of Carcinogenesis and the Age Distribution of Cancer in Man,” Journal of the National Cancer Institute, Vol. 61, No. 1, 1978, pp. 49-52.
 D. Crawford-Brown, “Scientific Models of Human Health Risk Analysis in Legal and Policy Decisions,” Law and Contemporary Problems, Vol. 64, No. 4, 2001, pp. 63-81.
 M. Mebust, D. Crawford-Brown, W. Hofmann and H. Schoelnberger, “Testing of a Biologically-Based Exposure-Response Model from in vitro to in vivo Conditions,” Regulatory Toxicology and Pharmacology, Vol. 35, No. 1, 2002, pp. 72-79. doi:10.1006/rtph.2001.1516
 D. Crawford-Brown, “The Concept of Sound Science in Risk Management Decisions,” Risk Management: An International Journal, Vol. 7, No. 3, 2005, pp. 7-20.
 D. Crawford-Brown and K. Brown, “A Framework for Judging the Carcinogenicity of Risk Agents,” Risk: Health, Safety and Environment, Vol. 8, No. 2, 1997, p. 307.
 I. Cote, “Challenges for Use of New Science in Risk Assessment and Regulation,” Presentation to Standing Committee on Use of Emerging Science for Environmental Decision Making, Washington DC, 2010.
 M. Anderson and D. Krewski, “Toxicity Testing in the 21st Century: Bringing the Vision to Life,” Toxicological Sciences, Vol. 107, No. 2, 2009, pp. 324-330.
 T. K. Nayak and S. Kundu, “Calculating and Describing Uncertainty in Risk Assessment: The Bayesian Approach,” Human and Ecological Risk Assessment, Vol. 7, No. 2, 2001, pp. 307-328. doi:10.1080/20018091094385
 J. Wilson, “Advanced Methods for Dose-Response Assessment: Bayesian Approaches, Final Report,” Resource for the Future, Washington DC, 2001.
 K. Crump, C. Chen, W. Chiu, T. Louis, C. Portier, R. Subramaniam and P. White, “What Role for Biologically Based Dose-Response Models in Estimating Low-Dose Risk?” Environmental Health Perspectives, Vol. 118, No. 5, 2010, pp. 585-588.
 D. Krewski, V. Hogan, M. C. Turner, P. L. Zeman, I. Mc-Dowell, N. Edwards and J. Losos, “An Integrated Framework for Risk Management and Population Health,” Human and Ecological Risk Assessment, Vol. 13, No. 6, 2007, pp. 1288-1312. doi:10.1080/10807030701655798
 J. Lemons, K. Shrader-Frechette and C. Cranor, “The Precautionary Principle: Scientific Uncertainty and Type I and Type II Errors,” Foundations of Science, Vol. 2, No. 2, 1997, pp. 207-236. doi:10.1023/A:1009611419680
 R. Raucher, S. Rubin, D. Crawford-Brown and M. Lawson, “Benefit-Cost Analysis for Drinking Water Standards: Efficiency, Equity, and Affordability Considerations in Small Communities,” Journal of Benefit-Cost Analysis, Vol. 1, No. 1, 2011, pp. 1-22.
 D. E. Savitz, “Is Statistical Significance Testing Useful in Interpreting Data?” Reproductive Toxicology, Vol. 7, No. 2, 1993, pp. 95-100. doi:10.1016/0890-6238(93)90242-Y
 European Chemicals Agency, “Practical Guide 2: How to Report Weight of Evidence,” Helsinki, 2010.