The EPA Health Risk Assessment of Methylcyclopentadienyl Manganese Tricarbonyl (MMT)

This paper describes the U.S. Environmental Protection Agency's assessment of potential health risks associated with the possible widespread use of a manganese (Mn)-based fuel additive, methylcyclopentadienyl manganese tricarbonyl (MMT). This assessment was significant in several respects and may be instructive in identifying certain methodological issues of general relevance to risk assessment. A major feature of the inhalation health risk assessment was the derivation of Mn inhalation reference concentration (RfC) estimates using various statistical approaches, including benchmark dose and Bayesian analyses. The exposure assessment component used data from the Particle Total Exposure Assessment Methodology (PTEAM) study and other sources to estimate personal exposure levels of particulate Mn attributable to the permitted use of MMT in leaded gasoline in Riverside, CA, at the time of the PTEAM study; on this basis it was then possible to predict a distribution of possible future exposure levels associated with the use of MMT in all unleaded gasoline. Qualitative as well as quantitative aspects of the risk characterization are summarized, along with inherent uncertainties due to data limitations.     

Topics in Microbial Risk Assessment: Dynamic Flow Tree Process

Microbial risk assessment is emerging as a new discipline in risk assessment. A systematic approach to microbial risk assessment is presented that employs data analysis for developing parsimonious models and accounts formally for the variability and uncertainty of model inputs using analysis of variance and Monte Carlo simulation. The purpose of the paper is to raise and examine issues in conducting microbial risk assessments. The enteric pathogen Escherichia coli O157:H7 was selected as an example for this study due to its significance to public health. The framework for our work is consistent with the risk assessment components described by the National Research Council in 1983 (hazard identification; exposure assessment; dose-response assessment; and risk characterization). Exposure assessment focuses on hamburgers, cooked a range of temperatures from rare to well done, the latter typical for fast food restaurants. Features of the model include predictive microbiology components that account for random stochastic growth and death of organisms in hamburger. For dose-response modeling, Shigella data from human feeding studies were used as a surrogate for E. coli O157:H7. Risks were calculated using a threshold model and an alternative nonthreshold model. The 95% probability intervals for risk of illness for product cooked to a given internal temperature spanned five orders of magnitude for these models. The existence of even a small threshold has a dramatic impact on the estimated risk.     

Principles for Conduct of Pest Risk Analyses: Report of an Expert Workshop

The North American Free Trade Agreement (NAFTA) and the General Agreement on Tariffs and Trade (GATT) have focused attention on risk assessment of potential insect, weed, and animal pests and diseases of livestock. These risks have traditionally been addressed through quarantine protocols ranging from limits on the geographical areas from which a product may originate, postharvest disinfestation procedures like fumigation, and inspections at points of export and import, to outright bans. To ensure that plant and animal protection measures are not used as nontariff trade barriers, GATT and NAFTA require pest risk analysis (PRA) to support quarantine decisions. The increased emphasis on PRA has spurred multiple efforts at the national and international level to design frameworks for the conduct of these analyses. As approaches to pest risk analysis proliferate, and the importance of the analyses grows, concerns have arisen about the scientific and technical conduct of pest risk analysis. In January of 1997, the Harvard Center for Risk Analysis (HCRA) held an invitation-only workshop in Washington, D.C. to bring experts in risk analysis and pest characterization together to develop general principles for pest risk analysis. Workshop participants examined current frameworks for PRA, discussed strengths and weaknesses of the approaches, and formulated principles, based on years of experience with risk analysis in other setting and knowledge of the issues specific to analysis of pests. The principles developed highlight the both the similarities of pest risk analysis to other forms of risk analysis, and its unique attributes.     

Environmental regulatory influence and product innovation: the contingency effects of organizational characteristics

This paper examines the relationship between environmental regulatory influence and product innovation in a multi-industry sample of manufacturing organizations. Our theory argues that the influence of environmental regulation on the level of product innovation in a manufacturing organization is at least partially contingent on the organization's internal characteristics—in particular, its structural flexibility and production process flexibility. Hypotheses are derived from our theory and tested, and the results are consistent with the conclusion that structural flexibility and production process flexibility moderate the environmental regulatory influence–product innovation relationship. Whether environmental regulation inhibits or promotes product innovation seems to depend at least in part on certain internal features of an organization. We discuss implications of our results for future organization studies research on environmental regulation, and for research on other types of external constraints on organizational performance.     

A Trivariate Distribution for the Height,Weight, and Fat of Adult Men*

Using exploratory data analysis, probability plots, scatterplots, and computer animations to rotate and visualize the data, we fit a trivariate Normal distribution to data for the height, the natural logarithm of body weight, and the body fat for 646 men between the ages of 50 and 80 years as reported by the medical staff of the U.S. Veterans Administration's “Normative Aging Study” in Boston, MA. Although these data do not include any children, women, or young men, the measurements represent the best data that we could find through a 4-year search. We believe that these data are well measured and reliable for men in the specified age range and that these data reveal an interesting statistical pattern for use in probabilistic PBPK models.     

Reconfiguring the Supply Network Using Current Performance Data

Reconfiguration of the supply chain network from time to time is essential for businesses to retain their competitive edge. This paper presents a methodology for reconfiguration of an existing supply chain network. The methodology is characterized by two decision levels. In the first level, the current network performance is evaluated and efficient practices are identified. In the next level, a model that incorporates efficient practices is developed to reconfigure the network. This integrated methodology allows for decision maker (DM) input throughout the process. The methodology has been implemented and tested in the reconfiguration of an outbound petroleum supply chain network for CountryMark Cooperative, Inc. In this case study, Data Envelopment Analysis (DEA) is used to analyze current operations and an integer programming (IP) model that incorporates efficiency metrics is developed for selection of distribution facilities and allocation of resources to the facilities. Use of this methodology can lead to improved operations and reduced operating expenses.     

Physician/hospital business relationships. Sorting through the options

Providers recognize the critical role of physician/hospital partnerships in the newly emerging health care delivery system. However, the possibilities available for establishing such partnerships can be overwhelming. The authors provide a critical review of the options for physician/hospital business relationships. They emphasize the need to match physician/hospital strategies to local market characteristics, develop market-based business objectives, and structure physician/hospital relationships to support the achievement of business objectives.     

Saturated main-effect designs for factorial experiments

The results of a computer search for saturated designs for 2ⁿ factorial experiments with n runs is reported, (where n = 2 mod 4). A complete search of the design space is avoided by focussing on designs constructed from cyclic generators. A method of searching quickly for the best generators is given. The resulting designs are as good as, and sometimes better than, designs obtained via search algorithms reported in the literature. The addition of a further factor having three levels is also considered. Here, too, a complete search is avoided by restricting attention to the most efficient part of the design space under p-efficiency.     

On perfect simulation for some mixtures of distributions

This paper studies the implementation of the coupling from the past (CFTP) method of Propp and Wilson (1996) in the set-up of two and three component mixtures with known components and unknown weights. We show that monotonicity structures can be exhibited in both cases, but that CFTP can still be costly for three component mixtures. We conclude with a simulation experiment exhibiting an almost perfect sampling scheme where we only consider a subset of the exhaustive set of starting values.