Scientific and Legal Perspectives on Science Generated for Regulatory Activities

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information

The Boundaries of Justice: The Challenges of Environmental Justice Assessments for Transportation Projects

Over recent decades, federal guidelines for transportation projects have required increasing attention to impacts on communities. Executive Order 12898 requires federal agencies to conduct environmental justice (EJ) assessments to determine if negative effects from projects will fall disproportionately on minority or low-income populations. Yet transportation agencies have not given specific guidance on the method for conducting such assessments. Therefore practitioners and researchers apply a variety of analytical techniques. This paper uses a case study of a planned road widening project in Daytona Beach, Florida, to compare the various methods currently used in EJ assessments. The choice of reference area and of method for determining the decision threshold for a finding of disproportionality are shown to have important implications for the outcome of an assessment. Because the spatial distribution of racial/ethnic and low-income groups will vary widely from place to place, practitioners and transportation agencies should not decide on the precise method, but carefully consider the characteristics and distribution of the data being used and select the method that most fairly represents the data distribution. Conducting genuine EJ assessments is not only required by federal regulations, but can head off conflicts, better reveal the true costs of projects, and allow for more equitable distribution of costs and benefits by better targeting mitigation efforts. Thus rather than shying away from EJ assessments, transportation agencies and practitioners should continue to explore methods and approaches.Master of City and Regional Plannin

The potential of social indicators: Minimum conditions for impact at the national level as suggested by a study of the use of ‘social indicators’ 73

Empirical evidence is presented which suggests that the use of social indicators among upper level government officials in the United States is minimal at present. Further, the level of use is not likely to be increased by improved measurement procedures, aesthetically improved packaging, or more widespread dissemination of such information among persons who influence policy decisions. The power of such information can be expected to be no greater than that of ‘mere’ statistics unless deliberate effort is made to institutionalize the importance of social indicators into government operations in conjunction with policy planning, goal setting, and commitment to the use of indicators as a system of national evaluation of progress toward the achievement of societal objectives. Several recommendations are made to develop the potential of social indicators and to increase their creative and useful application in matters of public policy at the national level.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/43692/1/11205_2004_Article_BF00352942.pd

Responses of Massachusetts hospitals to a state mandate to collect race, ethnicity and language data from patients: a qualitative study

<p>Abstract</p> <p>Background</p> <p>A Massachusetts regulation implemented in 2007 has required all acute care hospitals to report patients' race, ethnicity and preferred language using standardized methodology based on self-reported information from patients. This study assessed implementation of the regulation and its impact on the use of race and ethnicity data in performance monitoring and quality improvement within hospitals.</p> <p>Methods</p> <p>Thematic analysis of semi-structured interviews with executives from a representative sample of 28 Massachusetts hospitals in 2009.</p> <p>Results</p> <p>The number of hospitals using race, ethnicity and language data internally beyond refining interpreter services increased substantially from 11 to 21 after the regulation. Thirteen of these hospitals were utilizing patient race and ethnicity data to identify disparities in quality performance measures for a variety of clinical processes and outcomes, while 16 had developed patient services and community outreach programs based on findings from these data. Commonly reported barriers to data utilization include small numbers within categories, insufficient resources, information system requirements, and lack of direction from the state.</p> <p>Conclusions</p> <p>The responses of Massachusetts hospitals to this new state regulation indicate that requiring the collection of race, ethnicity and language data can be an effective method to promote performance monitoring and quality improvement, thereby setting the stage for federal standards and incentive programs to eliminate racial and ethnic disparities in the quality of health care.</p

A cross-sectional study of US rural adults’ consumption of fruits and vegetables: do they consume at least five servings daily?

<p>Abstract</p> <p>Background</p> <p>Rural residents are increasingly identified as being at greater risk for health disparities. These inequities may be related to health behaviors such as adequate fruits and vegetable consumption. There is little national-level population-based research about the prevalence of fruit and vegetable consumption by US rural population adults. The objective of this study was to examine the prevalence differences between US rural and non-rural adults in consuming at least five daily servings of combined fruits and vegetables.</p> <p>Methods</p> <p>Cross-sectional analysis of weighted 2009 Behavioral Risk Factor Surveillance Survey (BRFSS) data using bivariate and multivariate techniques. 52,259,789 US adults were identified as consuming at least five daily servings of fruits and vegetables of which 8,983,840 were identified as living in rural locales.</p> <p>Results</p> <p>Bivariate analysis revealed that in comparison to non-rural US adults, rural adults were less likely to consume five or more daily servings of fruits and vegetables (OR = 1.161, 95% CI 1.160-1.162). Logistic regression analysis revealed that US rural adults consuming at least five daily servings of fruits and vegetables were more likely to be female, non-Caucasian, married or living with a partner, living in a household without children, living in a household whose annual income was > $35,000, and getting at least moderate physical activity. They were also more likely to have a BMI of <30, have a personal physician, have had a routine medical exam in the past 12 months, self-defined their health as good to excellent and to have deferred medical care because of cost. When comparing the prevalence differences between rural and non-rural US adults within a state, 37 States had a lower prevalence of rural adults consuming at least five daily servings of fruits and vegetables and 11 States a higher prevalence of the same.</p> <p>Conclusions</p> <p>This enhanced understanding of fruit and vegetable consumption should prove useful to those seeking to lessen the disparity or inequity between rural and non-rural adults. Additionally, those responsible for health-related planning could benefit from the knowledge of how their state ranks in comparison to others vis-à-vis the consumption of fruits and vegetables by rural adults---a population increasingly being identified as one at risk for health disparities.</p