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The US Food Quality Protection Act--policy implications of variability and consumer risk.

The passage of the Food Quality Protection Act (FQPA) in August of 1996 increased the role of risk assessment in the decision-making process of the US Environmental Protection Agency (EPA). Although the law and guidance issued by the EPA provide for more sophisticated risk assessments, the databases for many chemicals may not be robust enough for such data-sensitive analyses. FQPA mandated a major change in how the EPA evaluates the safety of pesticides. This change was immediate, without provision for a phase-in period. Consequently, the EPA is still in the process of learning how to evaluate pesticides under the new paradigm. The EPA's task was further compounded by the lack of scientifically tested methodologies for evaluating aggregate and cumulative risk, as required under the new law. Clearly, the EPA is still in a state of transition between evaluating aggregate and cumulative risks to pesticides and evaluating them one chemical and one exposure route at a time. In all likelihood, the transition period will continue as the discipline of risk assessment develops the mental constructs and computational methodologies to fulfil the requirements of the law. In this interim period, therefore, policies are needed so the regulators and the regulated industry know what is currently acceptable, and how the EPA's thinking is evolving.

Consumer Product Safety↗

Joint occupational and environmental pollution prevention strategies: a model for primary prevention.

Occupational and environmental health issues are not always considered simultaneously when attempting to reduce or eliminate hazardous materials from our environment. Methods used to decrease exposure to hazardous chemicals in the workplace often lead to increased exposure in the environment and to the community outside the workplace. Conversely, efforts to control emissions of hazardous chemicals into the environment often lead to increased exposure to the workers inside the plant. There are government regulations in place that ensure a safe work environment or a safe outside environment; however, there is little integration of both approaches when considering the public's health as a whole. This article examines some of the reasons behind this dichotomy, focusing on the regulatory and policy frameworks with respect to workplace and environment that have resulted in the inability of the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) to coordinate their efforts to protect public health. The components of the Pollution Prevention Act and its potential to serve as a model for integrating occupational and environmental health are discussed. Limitations regarding enforcement of pollution prevention, as well as its disconnection from the work environment are equally highlighted. The article finishes by examining the barriers to integrating the occupational and environmental health paradigms and the promotion of primary prevention in public health.

Journal Article↗

[Experimental animal research in the EU legislation].

The legislation of the European Union captures experimental animal research only in part. Binding standards can be found in various legal records of the community-legislation, and in particular in the so-called guideline for animal experimentation 86/609/EWG. But these guidelines do not represent an actual animal protection measure but rather one of harmonisation with the primary goal of unification of the regulations of the participating states in order to prevent distortions of competition and trade barriers which could harm the common market. Although the guideline contains some practicable approaches in the direction of an up-to-date animal experimentation law, it only defines general goals which allows for considerable leeway in national implementation within the individual EU countries, and it has only a limited area of legal operation. On the one hand, only vertebrae are being included, and on the other, the law is only being applied in the area of applied research and protects only animals used in product- and substance-development or test procedures as well as those used in the framework of environmental protection. Various important fields of research are thus not subject to a common regulation and are assigned to national regulation. This concerns animal experimentation in education and training or for military or so-called defence-relevant medical purposes and, in particular, the whole area of basic research including the field of genetic engineering in animals with it's growing significance. The guideline is in need of widening it's scope of application as well as of various adjustments to recent scientific findings and developments in order to become suitable as a more restrictive animal protection law on the community level. It could also be desirable to include animal protection into the catalogue of community-goals in order to make it an independent component of the politics of the Union and to establish the groundwork for a decree of comprehensive and efficient regulations.

Animal Rights↗

Protective headgear for midwestern agriculture: a limited wear study.

Baseball caps are popular with farm workers, but have been criticized because they do not sufficiently shade the face, neck, and ears. U.S. Environmental Protection Agency standards require workers to wear chemical-resistant hoods or chemical-resistant hats with wide brims during the application of pesticides whose labels call for head protection. In this study, four farm workers wore baseball caps and two alternative types of headgear with wide brims for 20 to 36 hours during planting of corn and soybeans to compare performance features and practicality. Afterwards, researchers analyzed the headgear fabrics by gas chromatography or high-performance liquid chromatography to determine the levels at which five herbicides were deposited on the headgear: 2,4-D, metolachlor, acetochlor, ethalfluralin, and glyphosate. Chemical analysis revealed that 12 percent of specimens had detectable residue: levels of glyphosate in the nanograms-per-square-centimeter (ng/cm2) range and levels of 2,4-D in the micrograms-per-square-centimeter (microgram/cm2) range. Workers, however, preferred the baseball caps because of problems with the wind and feelings of embarrassment about wearing other types of headgear. An acceptable, protective substitute for the baseball cap has yet to be designed.

Adult↗

Control strategy optimization for attainment and exposure mitigation: case study for ozone in Macon, Georgia.

Implementation of more stringent 8-hour ozone standards has led the U.S. Environmental Protection Agency to designate nonattainment status to 474 counties nationwide, many of which had never previously violated air quality standards. As states select emission control measures to achieve attainment in these regions, their choices pose significant implications to local economies and the health of their citizens. Considering a case study of one such nonattainment region, Macon, Georgia, we develop a menu of potential controls that could be implemented locally or in neighboring parts of the state. The control menu offers the potential to control about 20-35% of ozone precursor emissions in most Georgia regions, but marginal costs increase rapidly beyond 15-20%. We link high-order ozone sensitivities with the control menu to identify cost-optimized strategies for achieving attainment and for alternative goals such as reducing spatially averaged or population-weighted ozone concentrations. Strategies targeted toward attainment of Macon ozone would prioritize local reductions of nitrogen oxides, whereas controls in the more densely populated Atlanta region are shown to be more effective for reducing statewide potential population exposure to ozone. A U.S. EPA-sanctioned approach for demonstrating ozone attainment with photochemical models is shown to be highly dependent on the choice of a baseline period and may not foster optimal strategies for assuring attainment and protecting human health.

Air Pollution↗

Environmental monitoring of remedial dredging at the New Bedford Harbor, MA, Superfund site.

New Bedford Harbor (NBH), MA, is a Superfund site because of high polychlorinated biphenyl (PCB) concentrations in the sediment. From April 1994 to September 1995, a remedial dredging operation (termed the "Hot Spot") removed the most contaminated sediments (PCB concentrations greater than 4000 microg/g) from the upper harbor. During remediation, a monitoring program assessed the potential environmental impacts to NBH and adjacent Buzzards Bay. The monitoring program was developed with input from federal, state, and local authorities. Site-specific decision criteria were established to assess net PCB transport, water column toxicity, and PCB bioaccumulation in blue and ribbed mussels (Mytilus edulis and Geukensia demissa, respectively). The remediation was completed without exceeding PCB net transport or acute toxicity effects specified in the decision criteria. In addition, PCB bioaccumulation in mussels during this time period was not significantly greater than pre- or post-operational measurements. The results indicated that approximately 14000 cubic yards of highly PCB contaminated sediment were permanently removed with minimal environmental effects. The lessons learned during this operation, as well as previous pilot studies at the site, will be used to make full-scale remedial efforts in NBH more efficient and environmentally protective.

Animals↗

Ecotoxicological evaluation of cork-boiling wastewaters.

Toxicity tests with Vibrio fischeri, Daphnia magna, and Lemna minor were used to evaluate acute and chronic toxicity of cork-boiling wastewaters and correlation analysis was performed with physicochemical parameters. Acute toxicity values (EC(50)) ranged from 2.3% to 24.2% in the Microtox test and from 4.4% to 29.5% in the Daphnia test. According to these values, 78% of the samples were classified as acutely toxic to the most sensitive species (V. fischeri). Significant correlation was obtained between EC(50) and chemical oxygen demand, biochemical oxygen demand after 5 days, total organic carbon, tannin and lignin and total solids. No significant correlation was found between the two acute tests. The D. magna chronic test showed significant differences between all tested concentrations and the control, with an EC(50) of 0.32%. An EC(50) value of 26.0% was calculated for L. minor. For the analysis of cork-boiling wastewater toxicity and routine biomonitoring, the use of the Microtox test is suggested, to afford greater environmental protection.

Aliivibrio fischeri↗

Environmental policy in economies in transition.

Considerable improvement in environmental pollution has been achieved, primarily due to targeted environmental policies rather than general economic developments. Some countries in central and eastern Europe have managed to reduce emissions even after the gross domestic product once again began to increase. Everywhere in the region, however, the cost-effectiveness of environmental spending is questionable. Most countries have established systems of earmarked resource and pollution taxes, which provide a sizable share in financing environmental investment. With stationary sources of pollution brought under increasingly effective control, the environmental problems in central and eastern Europe, and eventually in the newly independent states, will start to resemble those of developed market economies. As more activities become affected by environmental protection measures, cost-effectiveness considerations deserve increased attention.

Cost-Benefit Analysis↗

A survey of lead-based paint abatement projects performed in public buildings in Erie and Crawford Counties, Pennsylvania, during the time period 1995-1997.

A survey of lead-based paint abatement projects in public buildings of Crawford and Erie Counties, Pennsylvania, was conducted during the time period January 1995 to March 1997. These survey results suggest that few lead abatement projects were performed during this time period. Projects that were performed commonly did not employ proper lead abatement practices as described by the U.S. Occupational Safety and Health Administration, U.S. Environmental Protection Agency, and U.S. Department of Housing and Urban Development. These data suggest that most contractors and public officials have misunderstandings of both environmental regulations and required procedures for safe and effective lead-based paint abatement.

Air Pollution, Indoor↗

Radiobiology and gray science: flaws in landmark new radiation protections.

The International Commission on Radiological Protection--whose regularly updated recommendations are routinely adopted as law throughout the globe--recently issued the first-ever ICRP protections for the environment. These draft 2005 proposals are significant both because they offer the commission's first radiation protections for any non-human parts of the planet and because they will influence both the quality of radiation risk assessment and environmental protection, as well as the global costs of nuclear-weapons cleanup, reactor decommissioning and radioactive waste management. This piece argues that the 2005 recommendations are scientifically and ethically flawed, or gray, in at least three respects: first, in largely ignoring scientific journals while employing mainly "gray literature;" second, in relying on non-transparent dose estimates and models, rather than on actual radiation measurements; and third, in ignoring classical ethical constraints on acceptable radiation risk.

Dose-Response Relationship, Radiation↗

Epigenetic processes and cancer risk assessment.

The U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment encourages the use of mechanistic data in the assessment of human cancer risk at low (environmental) exposure levels. The key events that define a particular mode of action for tumor formation have been concentrated to date more on mutational responses that are broadly the result of induced DNA damage and enhanced cell proliferation. While it is clear that these processes are important in terms of tumor induction, other modes that fall under the umbrella of epigenetic responses are increasingly being considered to play an important role in susceptibility to tumor induction by environmental chemicals and as significant modifiers of tumor responses. Alterations in gene expression, DNA repair, cell cycle control, genome stability and genome reprogramming could be the result of modification of DNA methylation and chromatin remodeling patterns as a consequence of exposure to environmental chemicals. These concepts are described and discussed.

Animals↗

A process for evaluating adverse environmental impacts by cooling-water system entrainment at a California power plant.

A study to determine the effects of entrainment by the Diablo Canyon Power Plant (DCPP) was conducted between 1996 and 1999 as required under Section 316(b) of the Clean Water Act. The goal of this study was to present the U.S. Environmental Protection Agency (EPA) and Central Coast Regional Water Quality Control Board (CCRWQCB) with results that could be used to determine if any adverse environmental impacts (AEIs) were caused by the operation of the plant's cooling-water intake structure (CWIS). To this end we chose, under guidance of the CCRWQCB and their entrainment technical working group, a unique approach combining three different models for estimating power plant effects: fecundity hindcasting (FH), adult equivalent loss (AEL), and the empirical transport model (ETM). Comparisons of the results from these three approaches provided us a relative measure of confidence in our estimates of effects. A total of 14 target larval fish taxa were assessed as part of the DCPP 316(b). Example results are presented here for the kelp, gopher, and black-and-yellow (KGB) rockfish complex and clinid kelpfish. Estimates of larval entrainment losses for KGB rockfish were in close agreement (FH is approximately equals to 550 adult females per year, AEL is approximately equals to 1,000 adults [male and female] per year, and ETM = larval mortality as high as 5% which could be interpreted as ca. 2,600 1 kg adult fish). The similar results from the three models provided confidence in the estimated effects for this group. Due to lack of life history information needed to parameterize the FH and AEL models, effects on clinid kelpfish could only be assessed using the ETM model. Results from this model plus ancillary information about local populations of adult kelpfish suggest that the CWIS might be causing an AEI in the vicinity of DCPP.

Animals↗

Using human data to protect the public's health.

The value of using human data in the assessment and management of risk is evaluated. Although the use of such data has a long and successful history with environmental contaminants and the development of drugs and commercial chemicals, recent deliberations within the Environmental Protection Agency (EPA) have questioned this practice in part. Specifically, we evaluate the degree to which reference doses (RfDs) and reference concentrations (RfCs) derived from human data on EPA's Integrated Risk Information System (IRIS) differ with RfDs and RfCs that we estimate from experimental animal data. We also use several minimal risk levels of the Agency for Toxic Substances and Disease Registry (ATSDR) and tolerable intakes of Health Canada in this comparison. Human-based RfDs are more than threefold lower than the corresponding animal-based RfDs for 23% of the comparisons. Human- based RfDs or RfCs are lower than corresponding animal-based RfDs or RfCs for 36% of the comparisons. Furthermore, for 10 of 43 possible comparisons, insufficient experimental animal data are readily available or data are inappropriate to estimate either RfDs or RfCs. We also discuss human pharmacokinetic data from volunteer studies and mechanistic studies with human tissues in vitro and demonstrate through a series of case discussions that utilization of such data is important when making decisions to protect exposed individuals. Moreover, physiologically based pharmacokinetic (PBPK) modeling evaluates critical information in assessing interindividual variability and identifying at-risk populations. Within the limits of our analysis, we conclude that the direct use and interpretation of human data, in conjunction with data gathered from experimental animals, are public health protective policies that should be encouraged.

Animals↗

Determinants of the willingness-to-participate in an environmental intervention in a beirut neighborhood.

Participatory environmental management can empower communities and enhance the sustainability of environmental interventions. However, existing power structures and inequalities along class, gender, or ethnic lines could prevent part of the community from accessing the full benefits of the intervention. An analysis of determinants of the willingness-to-participate in an environmental intervention in a Beirut neighborhood is conducted. Socioeconomic, health-risk distribution, and perception of community efficacy are used as predictors. A randomly selected sample of residents was surveyed. Respondents were asked to specify the frequency with which they were willing to be involved in an intervention to address priority environmental problems in the neighborhood. Bivariate and multivariate ordinal regression analyses were conducted. Tests of significance were based on the 95% confidence intervals (CI) of the odds ratio (OR). Males versus females (OR = 4.89, P < 0.001), respiratory patients versus nonsufferers (OR = 5.65, P < 0.001), tenants versus house owners (OR = 2.98, P < 0.01), and the less educated versus the more educated (OR = 2.42, P < 0.05) were significantly more likely to be willing to participate. The reluctance of female community members to participate might be a major hindrance to community-based environmental protection and special strategies must be devised to overcome it. On the other hand, respondents suffering from an illness perceived to be related to environmental toxins are likely to be strong participants in environmental conservation efforts. Finally, the study yielded no evidence that belief or lack of it in the efficacy of community action is a good predictor of the willingness-to-participate in such action.

Adolescent↗

Performance of poly(vinyl alcohol) gel columns on the ion chromatographic determination of perchlorate in fertilizers.

Interest in possible sources of perchlorate (ClO4) that could lead to environmental release has been heightened since the Environmental Protection Agency placed this anion on its Contaminant Candidate List for drinking water. Although recent investigations have suggested that fertilizers are minor contributors to environmental perchlorate contamination overall, there is still interest in screening commercial products for possible contamination and quantitating perchlorate when it is found. Ion chromatography (IC) has been used for this application owing to its speed, low detection limits, widespread availability, and moderate ruggedness relative to other techniques. However, fertilizer matrixes complicate the IC analysis relative to potable water matrixes. In this study, the performance of poly(vinyl alcohol) gel resin IC columns (100 mm and 150 mm) was evaluated for fertilizer matrixes using method EPA/600/R-01/026. The NaOH eluent included an organic salt, sodium 4-cyanophenoxide. Detection was by suppressed conductivity. A set of 55 different field samples representing 48 products and previously used by the EPA to assess occurrence of perchlorate in fertilizers (EPA/600/R-01/049) was reanalyzed on the 150 mm column. The 100 mm column was used to further investigate the positive hits. Both columns gave satisfactory performance in fertilizer matrixes, with spike recoveries (+/- 15%), assured reporting levels (0.5-225 microg g(-1) except for one at 1,000 microg g(-1)), accuracy (relative error < 30% always and most < 15%), and precision [injection-to-injection reproducibility < 3% relative standard deviation (RSD)] comparable to those reported in other studies. Performance did not vary substantially between column lengths. Lastly, the results of this investigation provided further evidence in support of the conclusions that had been reached previously by the EPA on the occurrence of perchlorate in fertilizers.

Chromatography, Ion Exchange↗

The carcinogenicity of WHO fibers of silicon carbide: SiC whiskers compared to cleavage fragments of granular SiC.

A steep dose-response relationship for tumors was reported after application of 0.05 to 25 mg of whiskers of SiC in 1991 in a chronic intraperitoneal injection study in rats. In contrast, doses of 250 and 1000 mg of granular SiC did not cause tumors. The whiskers contained 107,000,000 fibers longer than 5 mum, per milligram while the granular sample was assumed to be free of such fibers. However, it has since been realized that even granular SiC may contain fibrous fragments that fulfill the definition of WHO fibers. It was the objective of our study to reanalyze the quantity of WHO fibers that were administered with the granular SiC. In addition, we examined whether the potency per WHO fiber was different for the SiC fragments and the SiC whiskers. Samples of the original granular and fibrous SiC were suspended in water and filtered. One half of each filter was analyzed by scanning electron microscopy (SEM, magnification x 2500), and transmission electron microscopy (TEM, x 10,000) was also performed for the SiC whiskers. The concentration of WHO fibers was 58,000 fibers/mg for the granular sample compared to 48,000,000 (SEM) and 42,000,000 (TEM) fibers/mg for the whiskers. The aspect ratio of the WHO fibers exceeded 10/1 for only 3.3% of the fragments but in each analysis for 96% of the whiskers. In addition, 0% of the fragments compared to 44% and 30% of the whiskers were more than 10 mum long. In total, 15 and 58 x 106 WHO fibers were injected with the granular SiC even though only 0.8% and 0% tumors were recorded. However, 20.1% and 43.3% tumors would have been expected if the carcinogenic potency were the same for the fragments and for the whiskers. We therefore conclude that carcinogenic potency is a function of the shapes of the WHO fibers and is much lower for SiC fragments than for whiskers. Hence carcinogenicity mainly is restricted to a subgroup of WHO fibers longer than about 10 and thinner than about 1 mum. This conclusion is in line with the optimal exposure index, which recently has been proposed by the U.S. Environmental Protection Agency (EPA) for asbestos.

Air Pollutants↗

A preliminary study on zero solid waste generation from pulverised coal combustion (PCC).

How to completely utilise the solid residues from pulverised coal combustion (PCC) has been a hard problem so far. On the basis of a first feasibility analysis and a preliminary experimental research, this study creates an innovative idea how to realise zero generation of solid waste from PCC. By adding some quick lime as well as some other mineralisers to the coal and grinding together before combustion, the mineral composition and property of ashes could be changed significantly. The formation of some cement minerals, such as Belite, would convert the ashes from solid waste into a kind of product that is similar to cement clinker. And this technology would have great effect on energy utilisation as well as environmental protection.

Coal↗

The integrated exposure uptake biokinetic model for lead in children: independent validation and verification.

The U.S. Environmental Protection Agency employs a model, the integrated exposure biokinetic (IEUBK) model for lead in children, for the assessment of risks to children posed by environmental lead at hazardous waste sites. This paper describes results of an effort to verify the consistency of the documentation with the computer model and to test the computer code using a group that is independent from those involved in the model development. This review concluded that the IEUBK model correctly calculates the equations specified in the IEUBK model theory documentation. However, several issues were identified on model documentation, model performance, and the C++ programming language code (i.e., IEUBK model source code) documentation. These issues affect the ability of an independent reviewer to understand the workings of the IEUBK model but not the model's reliability. As a result of these findings, recommendations have been provided for updating documentation to the model as well as associated adjustments to the model documentation.

Child↗