Misunderstanding Models in Environmental and Public Health Regulation

Computational models are fundamental to environmental regulation, yet their capabilities tend to be misunderstood by policymakers. Rather than rely on models to illuminate dynamic and uncertain relationships in natural settings, policymakers too often use models as “answer machines.” This fundamental misperception that models can generate decisive facts leads to a perverse negative feedback loop that begins with policymaking itself and radiates into the science of modeling and into regulatory deliberations where participants can exploit the misunderstanding in strategic ways. This paper documents the pervasive misperception of models as truth machines in U.S. regulation and the multi-layered problems that result from this misunderstanding. The paper concludes with a series of proposals for making better use of models in environmental policy analysis.The Kay Bailey Hutchison Center for Energy, Law, and Busines

Making Method Visible: Improving the Quality of Science-Based Regulation

Scientific inferences are theories about how the world works that scientists formulate based on their observations. One of the most difficult issues at the intersection of law and science is to determine whether the weight of evidence supports one scientific inference versus other competing interpretations of the observations. In administrative law, this difficulty is exacerbated by the behavior of both the courts and regulatory agencies. Agencies seldom achieve the requisite visibility that explains the analytical methods they use to reach their scientific inferences. Courts—because they appreciate neither the variety of inferential methods nor their epistemic foundations—do not demand this level of visibility from the agencies. We argue that much progress can be made toward visible, coherent, sciencebased regulations if courts ask two deceptively simple questions: (1) have the agency’s inferential methods been identified? and (2) does the agency explain how its methods are appropriate to the information on hand and how the methods support the agency’s inferences

Uncertainties Using Genomic Information for Evidence-Based Decisions

Part 1: UQ Need: Risk, Policy, and Decision MakingInternational audienceFor the first time, technology exists to monitor the biological state of an organism at multiple levels. It is now possible to detect which genes are activated or deactivated when exposed to a chemical compound; to measure how these changes in gene expression cause the concentrations of cell metabolites to increase or decrease; to record whether these changes influence the over-all health of the organism. By integrating all this information, it may be possible not only to explain how a person’s genetic make-up might enhance her susceptibility to disease, but also to anticipate how drug therapy might affect that individual in a particularized manner.But two related uncertainties obscure the path forward in using these advances to make regulatory decisions. These uncertainties relate to the unsettled notion of the term “evidence” — both from a scientific and legal perspective. From a scientific perspective, as models based on genomic information are developed using multiple datasets and multiple studies, the weight of scientific evidence will need to be established not only on long established protocols involving p-values, but will increasingly depend on still evolving Bayesian measures of evidentiary value. From a legal perspective, new legislation for the Food and Drug Administration has only recently made it possible to consider information beyond randomized, clinical trials when evaluating drug safety. More generally, regulatory agencies are mandated to issue laws based on a “rational basis,” which courts have construed to mean that a rule must be based, at least partially, on the scientific evidence. It is far from certain how judges will evaluate the use of genomic information if and when these rules are challenged in court

Rethinking Judicial Review of Expert Agencies

The role of generalist courts in reviewing the work of expert agencies is generally portrayed as either an institutional necessity on the one hand or a Pandora’s Box on the other. Courts are expected to ensure the accountability of agency actions through their legal oversight role, yet on matters of science policy they do not have the expertise of the agencies nor can they allow themselves to become amateur policymakers in the course of their review. Given these challenges, we set out to better understand what courts are doing in their review of agency science. We conducted a qualitative examination of the courts’ review of challenges to agency scientific choices in the entire set of the Environmental Protection Agency’s (EPA’s) National Ambient Air Quality Standards (NAAQS). Our study revealed an increasingly rigorous and substantive engagement in the courts’ review of scientific challenges to the EPA’s NAAQS over time that tracked the Agency’s own progress in developing rigorous analytical approaches. Our findings, albeit preliminary, suggest the emergence of a constructive partnership between the courts and agencies in science policy in NAAQS cases. In overseeing scientific challenges, the courts appear to serve as a necessary irritant, encouraging the agency to develop much stronger administrative governance and deliberative decisions on complex science-policy issues. Conversely, in developing stronger decisionmaking processes, the resulting agency efforts have a reciprocal, positive impact on the courts’ own standards for review. The courts and agencies thus appear to work symbiotically through their mutual efforts on the establishment of rigorous analytical yardsticks to guide the decision process. While our findings may be limited to the NAAQS, which likely present a best case in administrative process, the findings may still offer a grounded, normative model for imagining a constructive and even vital role for generalist courts in technically complex areas of social decision making.The Kay Bailey Hutchison Center for Energy, Law, and Busines

Understanding Environmental Models in Their Legal and Regulatory Context

Environmental models are playing an increasingly important role in most jurisdictions and giving rise to disputes. Despite this fact, lawyers and policy-makers have overlooked models and not engaged critically with them. This is a problematic state of affairs. Modelling is a semi-autonomous, interdisciplinary activity concerned with developing representations of systems and is used to evaluate regulatory behaviour to ensure it is legitimate. Models are thus relevant to lawyers and policy-makers but need to be engaged with critically due to technical, institutional, interdisciplinary and evaluative complexities in their operation. Lawyers and policy-makers must thus think more carefully about models and in doing so reflect on the nature of their own disciplines and fields. © The Author [2010]. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]