Risk assessment science-policy

PMRA (2003). General Principles for Performing Aggregate Exposure and Risk Assessments, Science Policy Notice, SPN2003-04, Pest Management Regulatory Agency, Ottawa, ON, Canada (website http //www.hc-sc.gc.ca/pmra-arla). 

Schirmer, K., E.M. Joyce, D.G. Dixon, B.M. Greenberg and N.C. Bols. Ability of the quinones arising from the UV irradiation of anthracene to induce 7-ethoxyresorufin o-deethylase activity in a trout liver cell line, In Environmental Toxicology and Risk Assessment Science, Policy, and Standarization - Implications for Environmental Decisions, Vol. 10, West Conshohocken, PA, ASTM, 2001, pp. 16—26. 

CANCER RISK ASSESSMENT, SCIENCE POLICY, AND REGULATORY FRAMEWORKS... 

Sunahara GI et al., Laboratory and field approaches to characterize the soil ecotoxicol-ogy of polynitro explosives, in Environmental Toxicology and Risk Assessment Science, Policy and Standardization-Implications for Environmental Decisions Tenth Volume STP 140, Greenberg BM, Hull RN, Roberts Jr. MH, Gensemer RW, Eds., American Society for Testing and Materials, West Conshohocken, PA, 2001, 293. 

Can Science Effectively Predict Risks Through Quantitative Risk Assessments - A Policy Perspective. Over the years, scientists have gained a great deal of experience, through the conduct of risk assessments, in how to perform each step in the risk assessment more efficiently and accurately. Improvements to risk assessment have been identified, significantly advancing the usefulness of risk assessment. 

Science policy issues and controversies underlie almost every aspect of cancer risk assessment. These policy issues are primarily a function of the scientific uncertainties inherent in risk assessment. As new scientific methods and data begin to fill in some of the data gaps and uncertainties in risk assessment, the role of policy will gradually recede, although there is no prospect of policy issues being mooted entirely in the foreseeable future. Moreover, the extent to which we substitute novel scientific data and models for preexisting policy inferences is itself an ongoing policy debate, as is the appropriate role of precaution and conservatism in risk assessment. 

Postle, M., Vernon, J., Zarogiannis, R, and Salado, R. (2003). Assessment of die impact of die new chemicals policy on occupational health [final report] Rrepared for die European Commission— Environment Directorate—General, Risk and Rolicy Analysts Limited, Norfolk, U.K., pp. 1—96. Reynolds, S. H., Stowers, S. J., Ratterson, R. M., Maronpot, R. R., Aaronson, S. A., and Anderson, M. W. (1987). Activated oncogenes in B6C3F1 mouse liver tumors Implications for risk assessment. Science 231, 1309-1316. 

Henderson, R.F. 1992. Short-term exposure guidelines for emergency response The approach of the Committee on Toxicology. Pp. 89—92 in Conference on Chemical Risk Assessment in the Department of Defense (DoD) Science, Policy, and Practice, H.J.Clewell, III, ed. American Conference of Governmental Hygienists, Cincinnati, OH. 

The science policy components of risk assessment have led to what have come to be called default assumptions. A default is a specific, automatically applied choice, from among several that are available (in this case it might be, for example, a model for extrapolating animal dose-response data to humans), when such a choice is needed to complete some undertaking (e.g., a risk assessment). We turn in the next chapter to the conduct of risk assessment and the ways in which default assumptions are used under current regulatory guidelines. We might say we have arrived at the central subject of this book. 

This use of animal evidence is based, in part, upon its scientific standing, but it is also based upon a science policy decision - it is one of the defaults present in the risk assessment process. Even in the absence of specific knowledge that the response detected in a toxicology study is relevant to humans, it will be assumed to be so -unless other data arrive to demonstrate that it is not relevant to humans (see below what is meant by other data ). Regulators and public health policies generally call for action even when the evidence regarding adverse health effects does not rise to the level necessary to establish causation in humans. 

These are the most important types of problem that arise which must be dealt with if risk assessments are to be completed. Again, there may be data available for some chemicals that allow reasonably accurate scientific answers for some of these questions, but as we emphasized in Chapter 7, scientific answers will generally be found wanting. Hence invocation of science policies - defaults. In Table 8.2, we find the most important regulatory defaults for risk assessment. 

While these contending forces will no doubt continue to contend, and to confuse the public, we should hope that mainstream science and thoughtful risk management policies will prevail. The risk assessment framework is central in the continuing search for the right balance point in these debates. 

Calculated Risks demystifies the science and policies of risk assessment. It has become a staple in risk education, and is essential reading for students and professionals in public health, environmental protection, and public policy. Thomas A. Burke, Professor and Associate Chair, Bloomberg School of Public Health, Johns Hopkins University... 

Rodricks has made the difficult topic of risk assessment accessible to the regulatory, policy and scientific communities. Calculated Risks focuses on the science of assessing health risks and provides a framework for understanding this complex topic. It should be required reading for those concerned about environmental pollution and protection of health and environment. Carol J. Henry, Vice President Science and Research,... 

The Handbook emphasized that other aspects than science influence risk characterization, and that science policy choices must be made to deal with uncertainties. Many choices are usually made during the course of the risk assessment process, resulting in a particular outcome. Therefore, it is possible to perform parallel risk assessments of the same data, but reach different results. 

Legislators Risk communication may influence and facilitate the legislative process Recipients of communication with limited knowledge of risk assessment but need to understand the role of science in informing policy... 

Because of the prominence of policy judgments in the interpretations of risk assessments, it is more accurate to say only that risk assessment has some (limited) scientific component. To call it science-based is an overstatement because it differs radically from science. 

Improvement will not come from policies based on the precautionary principle or any similar principle, which ignores the specifics of different risks and the benefits that accompany the substance or process that is being examined. Good policy cannot be derived by skipping over the fact that we live in a world of trade-offs and that actions have consequences. A regulatory and policy system that produces greater value for society must have a foundation of credibility. Far better to emphasize science in the risk assessment process and to examine the process and evaluate how well it works than to chase after lofty aspirations embodied in a principle without definition. 

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