Society through its governmental institutions regulates individual and collective behavior. A current case is that of EPA's new standards for particulate matter and ozone. The history of the setting of these standards is a fascinating story of the interplay of science, policy and values in which statistics and statisticians have played an unusually large role. In this talk I want to give an overview and point to challenges and challengers. The challenges come up because largely statistical evidence convinced the regulators that there was a problem. Now the challengers are asking us to provide statistical approaches to verifying that the regulations are having the desired effect; in other words, provide accountability. The Health Effects Institute (itself a product of the interaction of regulators and those regulated) in its strategic plan for 2000-2005 raises three questions regarding accountability in the area of regulation of air quality:
1. What are the public health objectives, and anticipated benefits, of air quality regulation? What should be measured?
2. What evidence of protective effects in the US population will be required to justify air quality regulation in terms of public health protection, and how can the accuracy of this evidence be assessed?
3. What approaches can be used to estimate the public health benefits of air quality regulation?
These questions provide a reasonable framework for the statistical questions that are being generated.
