Acceptable Cancer Risks: Probabilities and Beyond

The acceptability of cancer risk requires consideration of factors that extend beyond mere numerical representations, such as either individual lifetime risk in excess of background and excess incidence. Recently, use of these numbers has been tempered by the addition of qualitative weights-of-evidence that describe the degree of support provided by animal and epidemiologic results. Nevertheless, many other factors, most of which are not quantitative, require incorporation but remain neglected by the analyst eager to use quantitative results.

In this paper we show that simple risk measures are often fraught with problems. Moreover, these measures do not incorporate the very essence of acceptability, which includes notions of responsibility, accountability, equity, and procedural legitimacy, among others. We link the process of risk assessment to those legal and regulatory standards that shape it. These standards are among the principal means to resolve risk-related disputes and to enhance the balancing of competing interests when science and law meet on uncertain and often conjectural ground.

We conclude the paper with a proposal for the portfolio approach to manage cancer risks and to deal with uncertain scientific information. This approach leads to the concept of "provisional acceptability," which reflects the choices available to the decisionmaker, and the trade-offs inherent to such choices.     

Sample Design Considerations for Indoor Air Exposure Surveys

Concern about the potential for indoor air pollution has prompted recent surveys of radon and NO₂ concentrations In homes and personal exposure studies of volatile organics, carbon monoxide and pesticides, to name a few. The statistical problems in designing sample surveys that measure the physical environment are diverse and more complicated than those encountered in traditional surveys of human attitudes and attributes. This paper addresses issues encountered when designing indoor air quality (IAQ) studies. General statistical concepts related to target population definition, frame creation, and sample selection for area household surveys and telephone surveys are presented. The implications of different measurement approaches are discussed, and response rate considerations are described.     

Back to Basics

ABSTRACT

Tests of the compatibility of geomembrane (GM) samples with waste were conducted using U.S. Environmental Protection Agency (EPA) Method 9090 and the Comprehensive Testing System (CTS). The CTS is a multi-axial performance test capable of simultaneous cyclic mechanical loads and chemical exposure. The test chemicals consisted of solvents, transportation-related compounds, and synthesized landfill leachate. Method 9090 testing was unable to distinguish between the effects of individual chemicals to which the GM was subjected, while the CTS was able to provide statistically-significant differences that were also traceable to chemical properties of the solvent and the GM liner. Further, the time required for changes in mechanical properties of the GM was significantly shorter than would be expected based upon diffusion of the solvent into the GM alone. The combination of chemical attack with mechanical load was found to enhance both reduction in mechanical properties and the ability of the solvent to diffuse into the GM. The CTS is a more realistic test than the existing standard test methods because of its ability to provide multi-axial loads and chemical exposure simultaneously.     

Revised Air Quality Surveillance Requirements for State Implementation Plans

The National Ambient Air Quality Monitoring Program is carried out by state and local air pollution control agencies in support of their State Implementation Plans (SIP’s). The current EPA regulations which specify the characteristics of these state monitoring programs are undergoing change as a result of a comprehensive review by an independent work group. These revised regulations, which are described in the paper, are intended to improve the quality, timeliness, and usability of the data generated by the states for all data users. In addition, the revised regulations seek to bring about; (a) national consistency in monitoring site locations through standardized siting procedures; (b) improved network operations by means of a minimum quality assurance program; (c) reduced network inflexibility through an annual network review process; and (d) reduced data reporting through changed data reporting procedures.     

Ambient Ozone Concentration Patterns among Eastern U.S. Urban Areas Using Factor Analysis

Data on dally maximum ozone concentrations measured at ambient air monitoring stations operated by state and local air pollution control agencies in the Eastern United States were analyzed using principal factor analysis. Four orthogonal factors representing O₃ formation potentials were derived using the statistical package SPSS; these factors accounted for over two-thirds of the variations in 1978 summer O₃ levels at 21 urban-oriented stations. The analysis confirmed that O₃ variations are similar among stations within defined geographical areas; this confirmation supports the widely held theory that ambient O₃ formations are reglonwlde. The analysis suggested that trends analysis for determining general progress in improving O₃ air quality should be based on aggregate statistics from clusters of monitors rather than from a single monitoring station within areas associated with the derived factors.     

Managing Baltic Sea fisheries under contrasting production and predation regimes: ecosystem model analyses

Based on an earlier published ecosystem model, we have explored possible effects of different management scenarios for the Baltic Sea. The scenarios include an oligotrophication of the system, a drastic increase in the number of seals, and changes in the fishery management. From these simulations we conclude that fisheries, seals, and eutrophication all have strong and interacting impacts on the ecosystem. These interactions call for integrated management. The modeling highlights the potential for conflicts among management mandates such as flourishing fisheries, rebuilt seal populations, and substantially reduced eutrophication. The results also suggest that fisheries management reference points have to be adjusted in response to changes in the presence of natural predators or ecosystem productivity.     

Potential human health benefits of antibiotics used in food animals: a case study of virginiamycin

Risk management of food-animal antibiotics has reached a crucial juncture for public health officials worldwide. While withdrawals of animal antibiotics previously used to control animal bacterial illnesses are being encouraged in many countries, the human health impacts of such withdrawals are only starting to be understood. Increases in animal and human bacterial illness rates and antibiotic resistance levels in humans in Europe despite bans on animal antibiotics there have raised questions about how animal antibiotic use affects human health. This paper presents a quantitative human health risk and benefits assessment for virginiamycin (VM), a streptogramin antibiotic recommended for withdrawal from use in food animals in several countries. It applies a new quantitative Rapid Risk Rating Technique (RRRT) that estimates and multiplies data-driven exposure, dose-response, and consequence factors, as suggested by WHO (2003) to estimate human health impacts from withdrawing virginiamycin. Increased human health risks from more pathogens reaching consumers if VM use is terminated (6660 estimated excess campylobacteriosis cases per year in the base case) are predicted to far outweigh benefits from reduced streptogramin-resistant vancomycin-resistant Enterococcus faecium (VREF) infections in human patients (0.27 estimated excess cases per year in the base case). While lack of information about impacts of VM withdrawal on average human illnesses-per-serving of food animal meat precludes a deterministic conclusion, it appears very probable that such a withdrawal would cause many times more human illnesses than it would prevent. This qualitative conclusion appears to be robust to several scientific and modeling uncertainties.     

Heavy metal distribution and controlling factors within coastal plain sediments, Bells Creek catchment, southeast Queensland, Australia

Bells Creek catchment in southeast Queensland (Australia) is a non-industrialised coastal plain limited to small settlements and agricultural land. A study was initiated to examine elevated metal concentrations and to assess horizontal and vertical distribution of those elements. Ninety-nine samples were analysed for Cr, V, Ni, Cu, Zn, Pb, As, Fe, Mn and Al. Total organic carbon, sulfur content and mineralogy of samples along with land-use practices across the catchment were used to identify processes which influence metal distribution. A comparison between metal concentration within the study area and mean heavy metal content of standard sandstone showed that except for Mn, all other metals showed elevated levels throughout the catchment. When metal concentrations were compared to parent bedrock, however, it was concluded that elevated levels are likely to be natural. A normalisation procedure was applied to the data set and this analysis validated that elevated trace metal concentrations in most samples are not due to artificial contamination. While surficial estuarine sediments were only enriched in V, soils were dominantly enriched in Cr, Zn and V. Overall, geochemistry and mineralogy of the samples show the effect of both natural and anthropogenic inputs to the catchment, however, natural processes are more dominant than anthropogenic inputs in concentrating metals.