Susan E. Dudley

Improving Weight of Evidence Approaches to Chemical Evaluations

Federal and other regulatory agencies often use or claim to use a weight of evidence (WoE) approach in chemical evaluation. Their approaches to the use of WoE, however, differ significantly, rely heavily on subjective professional judgment, and merit improvement. We review uses of WoE approaches in key articles in the peer-reviewed scientific literature, and find significant variations. We find that a hypothesis-based WoE approach, developed by Lorenz Rhomberg et al., can provide a stronger scientific basis for chemical assessment while improving transparency and preserving the appropriate scope of professional judgment. Their approach, while still evolving, relies on the explicit specification of the hypothesized basis for using the information at hand to infer the ability of an agent to cause human health impacts or, more broadly, affect other endpoints of concern. We describe and endorse such a hypothesis-based WoE approach to chemical evaluation.

Social cost of carbon: Domestic duty

![Figure][1] Cost-effective emissions controls depend on calculating the domestic and global social costs of carbon. PHOTO:

The role of transparency in regulatory governance: comparing US and EU regulatory systems

The United States and European Union have focused on improving the practices used to develop and implement legal requirements as a way to improve the quality of regulations themselves. Transparency in the regulatory process, from determining regulatory goals, to evaluating alternative means to achieve those goals, to enforcing regulatory requirements, features high on the agenda of cross-cutting government reform programs that address the issue of ‘regulatory quality.’ This article examines the transparency of procedures in the US and the EU related to impact analysis and public comment. It examines the importance of transparency for ensuring the effectiveness of these two regulatory practices, summarizes regulatory procedures in the US and the EU, compares the different approaches, and highlights the relative merits of each.

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Will the Occupational Safety and Health Administration's Proposed Standards for Occupational Exposure to Respirable Crystalline Silica Reduce Workplace Risk?

The Occupational Safety and Health Administration (OSHA) is developing regulations to amend existing standards for occupational exposure to respirable crystalline silica by establishing a new permissible exposure limit as well as a series of ancillary provisions for controlling exposure. This article briefly reviews OSHAs proposed regulatory approach and the statutory authority on which it is based. It then evaluates OSHAs preliminary determination of significant risk and its analysis of the risk reduction achievable by its proposed controls. It recognizes that OSHA faces multiple challenges in devising a regulatory approach that reduces exposures and health risks and meets its statutory goal. However, the greatest challenge to reducing risks associated with silica exposure is not the lack of incentives (for either employers or employees) but rather lack of information, particularly information on the relative toxicity of different forms of silica. The article finds that OSHAs proposed rule would contribute little in the way of new information, particularly since it is largely based on information that is at least a decade old--a significant deficiency, given the rapidly changing conditions observed over the last 45 years. The article concludes with recommendations for alternative approaches that would be more likely to generate information needed to improve worker health outcomes.

Comment on Löfstedt's 'The substitution principle in chemical regulation: a constructive critique'

This commentary on Ragnar Löfstedt’s constructive critique of the substitution principle observes that while the principle is intuitively appealing, it begins to unravel on closer examination. When considering government intervention to effect societal improvements, it is important to be aware of two problems. First, predicting the actual outcome of an intervention is very difficult, and second, people disagree about what constitutes ‘societal improvements’. This commentary examines the substitution principle in light of those problems and offers a set of guiding principles for evaluating and developing alternative policy frameworks that will improve public health and welfare.

The Effect of Regulation on Innovation

Clear rules of the game (e.g., established property rights and institutions of exchange) are important for innovation and entrepreneurship to flourish, but how those rules are defined is important. The scope and reach of federal regulation in the United States has been increasing over the last 30 years, and while federal agencies often try to quantify the benefits and costs of their regulations before they are issued, those measures are necessarily static, and bounded by data available to, and assumptions made by, the analyst. These analyses cannot capture the organic, dynamic nature of innovation nor anticipate how participants in a market might respond to incentives created by the regulation. Arguments that support “technology forcing” regulations often neglect the opportunities foregone when resources are devoted in a particular direction. Further, because regulations can confer competitive advantage on certain market participants at the expense of others, they provide incentives to focus innovative energy on influencing the rules, rather than innovating along more productive dimensions. Scholarship of the 1960s and 1970s showed that price and entry regulation tended to benefit organized interests at the expense of the broader public interest, and led to the economic deregulation movement that served to increase competition in several previously-regulated industries, with resulting improvements in innovation and consumer welfare. I hope to generate discussion of the effects of regulatory practices on innovation using current examples.