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PubMed1990

Comprehensive waste regulation dumped. A limited demonstration project is all that remains.

When medical wastes started washing up along the Eastern Seaboard and the shores of the Great Lakes in 1988, healthcare providers became subject to close public scrutiny. Not only was the situation deplorable; the solution, they feared, would keep them entangled in red tape for years. Public outcry sent members of Congress scurrying to legislate medical waste regulation. But what many had predicted would be a comprehensive, nationwide regulation that tracked medical waste from cradle to grave turned out to be a demonstration project limited to Puerto Rico and four states in the Northeast. The Medical Waste Tracking Act of 1988 went into effect in June 1989. When it expires in June 1991, the Environmental Protection Agency (EPA) will report to Congress on the program's impact, presumably with an eye toward whether further legislation and continuing regulations are necessary. In the meantime, participating states must establish a system of tracking medical waste from its point of generation to its disposal by either incineration or burial in a landfill. Medical waste generators must separate it from other kinds of waste and place it in special labeled containers. They must also prepare a tracking form that accompanies the cargo and requires sign-off by generator, transporter, and disposal facility operator. The EPA has legal access to medical waste tracking forms and can inspect any site where medical wastes are located. Violators are subject to stiff civil and criminal penalties.

Facility Regulation and Control↗
PubMed2006

Animal carcinogenicity studies: implications for the REACH system.

The 2001 European Commission proposal for the Registration, Evaluation and Authorisation of Chemicals (REACH) aims to improve public and environmental health by assessing the toxicity of, and restricting exposure to, potentially toxic chemicals. The greatest benefits are expected to accrue from decreased cancer incidences. Hence the accurate identification of chemical carcinogens must be a top priority for the REACH system. Due to a paucity of human clinical data, the identification of potential human carcinogens has conventionally relied on animal tests. However, our survey of the US Environmental Protection Agency's (EPAs) toxic chemicals database revealed that, for a majority of the chemicals of greatest public health concern (93/160, i.e. 58.1%), the EPA found animal carcinogenicity data to be inadequate to support classifications of probable human carcinogen or non-carcinogen. A wide variety of species were used, with rodents predominating; a wide variety of routes of administration were used; and a particularly wide variety of organ systems were affected. These factors raise serious biological obstacles that render accurate extrapolation to humans profoundly difficult. Furthermore, significantly different International Agency for Research on Cancer assessments of identical chemicals, indicate that the true human predictivity of animal carcinogenicity data is even poorer than is indicated by the EPA figures alone. Consequently, we propose the replacement of animal carcinogenicity bioassays with a tiered combination of non-animal assays, which can be expected to yield a weight-of-evidence characterisation of carcinogenic risk with superior human predictivity. Additional advantages include substantial savings of financial, human and animal resources, and potentially greater insights into mechanisms of carcinogenicity.

Animals↗
PubMed2004

Accuracy and repeatability of commercial geocoding.

The authors estimated accuracy and repeatability of commercial geocoding to guide vendor selection in the Life Course Socioeconomic Status, Social Context and Cardiovascular Disease study (2001-2002). They submitted 1,032 participant addresses (97% in Maryland, Minnesota, Mississippi, or North Carolina) to vendor A twice over 9 months and measured repeatability as agreement between levels of address matching, discordance (%) between statistical tabulation areas, and median distance (d, in meters) and bearing (theta;, in degrees) between coordinates assigned on each occasion (H(o):Sigma(i)( = 1 -->) (n) [theta;(i) /n] = 180 degrees ). They also submitted 75 addresses of nearby air pollution monitors (77% urban/suburban; 69% residential/commercial) to vendors A and B and then measured accuracy by comparing vendor- and US Environmental Protection Agency (EPA)-assigned geocodes using the above measures. Repeatability of geocodes assigned by vendor A was high (kappa = 0.90; census block group discordance = 5%; d < 1 m; theta; = 177 degrees ). The match rate for EPA monitor addresses was higher for vendor B versus A (88% vs. 76%), but discordance at census block group, tract, and county levels also was, respectively, 1.4-, 1.9-, and 5.0-fold higher for vendor B. Moreover, coordinates assigned by vendor B were further from those assigned by the EPA (d = 212 m vs. 149 m; theta; = 131 degrees vs. 171 degrees ). These findings suggest that match rates, repeatability, and accuracy should be used to guide vendor selection.

Aged↗
PubMed2002

Comparing Clean Water Act Section 316(b) policy options.

This paper develops a comparative framework for policy proposals involving fish protection and Section 316(b) of the Clean Water Act (CWA). Section 316(b) addresses the impingement and entrainment of fish by cooling-water intake structures used principally by steam electric power plants. The framework is motivated by examining the role of adverse environmental impacts (AEIs) in the context of Section 316(b) decision making. AEI is mentioned in Section 316(b), but not defined. While various AEI options have been proposed over the years, none has been formalized through environmental regulations nor universally accepted. Using a multiple values approach from decision analysis, AEIs are characterized as measurement criteria for ecological impacts. Criteria for evaluating AEI options are identified, including modeling and assessment issues, the characterization of ecological value, regulatory implementation, and the treatment of uncertainty. Motivated by the difficulties in defining AEI once and for all, a framework is introduced to compare options for 316(b) decision making. Three simplified policy options are considered, each with a different implicit or explicit AEI approach: (1) a technology-driven rule based on a strict reading of the 316(b) regulatory text, and for which any impingement and entrainment count as AEI, (2) a complementary, open-ended risk-assessment process for estimating population effects with AEI characterized on a site-specific basis, and (3) an intermediate position based on proxy measures such as specially constructed definitions of littoral zone, sensitive habitat, or water body type. The first two proposals correspond roughly to responses provided, respectively, by the Riverkeeper environmental organization and the Utility Water Act Group to the U.S. Environmental Protection Agency (EPA)'s proposed 316(b) new facilities rule of August 2000; the third example is a simplified form of the EPA's proposed August 2000 new facilities rule itself. The simplified policy positions are compared using the three dimensions of the comparative policy framework: (1) the role of CWA philosophy or vision, such as the use of technology-forcing rules, (2) regulatory policy implementation, and (3) the role for scientific information and the knowledge base. Strengths and weaknesses of all three 316(b) policy approaches are identified. The U.S. EPA's final new facilities rule of November 2001 is briefly characterized using the comparative policy framework and used to further illustrate the approach.

Animals↗
PubMed1990

Failure of the STER-O-LIZER MD 200 to pass the EPA sporicidal test.

The U.S. Environmental Protection Agency (EPA) officially licenses and authorizes use of commercial gas and liquid sterilants. Products registered by the EPA include ethylene oxide gas, formalin-alcohol vapor, glutaraldehyde liquid, and chlorine dioxide liquid. One product that is exempted from EPA registration is the STER-O-LIZER MD 200, in which the active component is electropotentiated saline solution. The manufacturer of the STER-O-LIZER claims that the device sterilizes surgical instruments in 2 minutes. Sterilization claims for the product are based on a test selected by the manufacturer. The EPA, however, is not concerned about the use of the STER-O-LIZER because it is non-toxic to humans. This study tested the validity of the manufacturer's claim by using EPA standards.

Bacillus subtilis↗
PubMed1989

Overview of proposed revisions to the superfund hazard ranking system.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 required the federal government to establish criteria for setting priorities among releases of hazardous substances, pollutants, and contaminants. The U.S. Environmental Protection Agency responded by developing the Hazard Ranking System (HRS), which is a scoring system used to establish the National Priorities List (NPL). The Superfund Amendments and Reauthorization Act of 1986 required EPA to amend the HRS so it will more accurately assess relative risks and take into account certain specific elements of risk. On December 23, 1988, EPA published in the Federal Register the proposed rule to revise the HRS. EPA expects to issue the final rule in 1990 after reviewing public comments. This paper describes the proposed revisions and summarizes major technical findings that support the revisions. As a result of the HRS revisions, there may be some changes in the types of sites that score high enough to be placed on the NPL. A projection of those changes is discussed.

Environmental Pollutants↗
PubMedDate not supplied

Application of counterpropagation artificial neural network for modelling properties of fish antibiotics.

The present study focuses on fish antibiotics which are an important group of pharmaceuticals used in fish farming to treat infections and, until recently, most of them have been exposed to the environment with very little attention. Information about the environmental behaviour and the description of the environmental fate of medical substances are difficult or expensive to obtain. The experimental information in terms of properties is reported when available, in other cases, it is estimated by standard tools as those provided by the United States Environmental Protection Agency EPISuite software and by custom quantitative structure-activity relationship (QSAR) applications. In this study, a QSAR screening of 15 fish antibiotics and 132 xenobiotic molecules was performed with two aims: (i) to develop a model for the estimation of octanol--water partition coefficient (logP) and (ii) to estimate the relative binding affinity to oestrogen receptor (log RBA) using a model constructed on the activities of 132 xenobiotic compounds. The custom models are based on constitutional, topological, electrostatic and quantum chemical descriptors computed by the CODESSA software. Kohonen neural networks (self organising maps) were used to study similarity between the considered chemicals while counter-propagation artificial neural networks were used to estimate the properties.

Animals↗
PubMed2005

A novel approach for the determination of detection limits for metal analysis of environmental water samples.

Despite the widespread use of the USEPA method (U.S. Environmental Protection Agency, 40 CFR 136 Appendix B) for the determination of method detection limit (MDL), criticisms have been raised that the method does not account for measurement bias and outliers that subsequently lead to a common misunderstanding of the requirement for the determination of MDL. This paper demonstrates that it is difficult to follow the USEPA method for verifying the MDL for analysis involving multiple metals and proposes a precision and bias criterion for determining the MDL. A multiple-point fitted profile, based on the correlation between relative standard deviation (RSD) and concentration, is used to derive a robust MDL value. Representative examples of As, Ca, Cr, and Cu are used to illustrate this procedure. A procedure for identifying outliers is also discussed.

Arsenic↗
PubMed1994

An alternative approach to dietary exposure assessment.

The method of dietary exposure assessment currently used by the Environmental Protection Agency (EPA), the Dietary Residue Evaluation System (DRES), combines a consumption distribution derived from the United States Department of Agriculture (USDA) 1977-1978 Nationwide Food Consumption Survey (NFCS) with a single estimate of residue level. The National Academy of Sciences recommended that EPA incorporate both the distribution of residues and the distribution of consumption into their exposure assessment methodology and proposed using a Monte Carlo approach. This paper presents an alternative method, the Joint Distributional Analysis (JDA), that combines the consumption and residue distributions, without relying on random sampling or fitting theoretical distributions like the Monte Carlo method. This method permits simultaneous analysis of the entire diet, including assessing exposure from residues in different foods.

Aldicarb↗
PubMed2002

Assessing human health response in life cycle assessment using ED10s and DALYs: part 1--Cancer effects.

Life cycle assessment (LCA) is a framework for comparing products according to their total estimated environmental impact, summed over all chemical emissions and activities associated with a product at all stages in its life cycle (from raw material acquisition, manufacturing, use, to final disposal). For each chemical involved, the exposure associated with the mass released into the environment, integrated over time and space, is multiplied by a toxicological measure to estimate the likelihood of effects and their potential consequences. In this article, we explore the use of quantitative methods drawn from conventional single-chemical regulatory risk assessments to create a procedure for the estimation of the cancer effect measure in the impact phase of LCA. The approach is based on the maximum likelihood estimate of the effect dose inducing a 10% response over background, ED10, and default linear low-dose extrapolation using the slope betaED10 (0.1/ED10). The calculated effects may correspond to residual risks below current regulatory compliance requirements that occur over multiple generations and at multiple locations; but at the very least they represent a "using up" of some portion of the human population's ability to accommodate emissions. Preliminary comparisons are performed with existing measures, such as the U.S. Environmental Protection Agency's (U.S. EPA's) slope factor measure q1*. By analyzing bioassay data for 44 chemicals drawn from the EPA's Integrated Risk Information System (IRIS) database, we explore estimating ED10 from more readily available information such as the median tumor dose rate TD50 and the median single lethal dose LD50. Based on the TD50, we then estimate the ED10 for more than 600 chemicals. Differences in potential consequences, or severity, are addressed by combining betaED10 with the measure disability adjusted life years per affected person, DALYp. Most of the variation among chemicals for cancer effects is found to be due to differences in the slope factors (betaED10) ranging from 10(-4) up to 10(4) (risk of cancer/mg/kg-day).

Carcinogens, Environmental↗
PubMed2003

No evidence of dioxin cancer threshold.

The U.S. Environmental Protection Agency (EPA) has developed an estimate of the human cancer risk from dioxin, using the standard low-dose linear extrapolation approach. This estimate has been controversial because of concern that it may overestimate the cancer risk. An alternative approach has been published and was presented to the U.S. EPA Science Advisory Board's Dioxin Review Panel in November 2000. That approach suggests that dioxin is a threshold carcinogen and that the threshold is an order of magnitude above the exposure levels of the general population. We have reexamined the threshold analysis and found that the data have been incorrectly weighted by cohort size. In our reanalysis, without the incorrect weighting, the threshold effect disappears.

Carcinogens↗
PubMed1997

Variation of 222Rn in public drinking water supplies.

The U.S. Environmental Protection Agency has proposed regulating 222Rn in public drinking water. When implemented, the regulation will require periodic sampling to demonstrate compliance. The work reported in this paper was conducted to evaluate how reliably grab samples can be used to characterize the average 222Rn concentration in a groundwater source. Periodic samples were collected from 14 wells over sampling periods ranging from 2 to 26 mo. Samples were collected using a "slow-flow" collection method, and samples were analyzed using liquid scintillation techniques. The results reveal variation in 222Rn concentration over the study period; however, for the 1,468 samples collected from the 14 wells, approximately 97% of the measurement results were within 30% of the mean value for the well.

Geological Phenomena↗
PubMed2002

VOCs, pesticides, nitrate, and their mixtures in groundwater used for drinking water in the United States.

Samples of untreated groundwater from 1255 domestic drinking-water wells and 242 public supply wells were analyzed as part of the National Water-Quality Assessment Program of the U.S. Geological Survey between 1992 and 1999. Wells were sampled to define the regional quality of the groundwater resource and, thus, were distributed geographically across large aquifers, primarily in rural areas. For each sample, as many as 60 volatile organic compounds (VOCs), 83 pesticides, and nitrate were analyzed. On the basis of previous studies, nitrate concentrations as nitrogen > or = 3 mg/L were considered to have an anthropogenic origin. VOCs were detected more frequently (44%) than pesticides (38%) or anthropogenic nitrate (28%). Seventy percent of the samples contained at least one VOC, pesticide, or anthropogenic nitrate; 47% contained at least two compounds; and 33% contained at least three compounds. The combined concentrations of VOCs and pesticides ranged from about 0.001 to 100 microg/L, with a median of 0.02 microg/L. Water from about 12% of the wells contained one or more compounds that exceeded U.S. Environmental Protection Agency drinking-water standards or human health criteria, primarily because of nitrate concentrations exceeding the maximum contaminant level in domestic wells. A mixture is defined as a unique combination of two or more particular compounds, regardless of the presence of other compounds that may occur in the same sample. There were 100 mixtures (significantly associated with agricultural land use) that had a detection frequency between 2% and 19%. There were 302 mixtures (significantly associated with urban land use) that had a detection frequency between 1% and <2%. Only 14 compounds (seven VOCs, six pesticides, and nitrate) contributed over 95% of the detections in these 402 mixtures; however, most samples with these mixtures also contain a variety of other compounds.

Data Collection↗
PubMed2002

Evaluating quantitative formulas for dose-response assessment of chemical mixtures.

Risk assessment formulas are often distinguished from dose-response models by being rough but necessary. The evaluation of these rough formulas is described here, using the example of mixture risk assessment. Two conditions make the dose-response part of mixture risk assessment difficult, lack of data on mixture dose-response relationships, and the need to address risk from combinations of chemicals because of public demands and statutory requirements. Consequently, the U.S. Environmental Protection Agency has developed methods for carrying out quantitative dose-response assessment for chemical mixtures that require information only on the toxicity of single chemicals and of chemical pair interactions. These formulas are based on plausible ideas and default parameters but minimal supporting data on whole mixtures. Because of this lack of mixture data, the usual evaluation of accuracy (predicted vs. observed) cannot be performed. Two approaches to the evaluation of such formulas are to consider fundamental biological concepts that support the quantitative formulas (e.g., toxicologic similarity) and to determine how well the proposed method performs under simplifying constraints (e.g., as the toxicologic interactions disappear). These ideas are illustrated using dose addition and two weight-of-evidence formulas for incorporating toxicologic interactions.

Dose-Response Relationship, Drug↗
PubMedDate not supplied

Hazardous waste disposal and the clinical laboratory.

Negligent, unregulated hazardous waste management has resulted in real and potential threats to public health and safety. The federal government has responded with laws and regulations aimed at the producers of hazardous waste, including clinical laboratories. Clinical laboratory managers must understand how the requirements apply to their facilities and how to comply with them, or risk violating the law. The Resources Conservation and Recovery Act (RCRA) imposes controls on hazardous waste management through the Code of Federal Regulations (CFR). The Environmental Protection Agency (EPA) and the Department of Transportation (DOT) regulate these activities through 40 CFR and 49 CFR, respectively. 49 CFR specifies the characteristics of hazardous waste and lists more than 400 toxic chemicals, including several commonly used in clinical laboratories. Laboratories must conduct chemical inventories to determine if they should obtain an EPA identification number as a hazardous waste generator. Most clinical laboratories can operate satellite accumulation points and accumulate, store, transport, and dispose of waste in accordance with EPA and DOT regulations. Regulations pertaining to infectious waste, sure to affect many clinical laboratories, are being developed now by the EPA. The tracking system mandated by the federal government can be supplemented by state and local authorities and poses a significant regulatory challenge to clinical laboratory managers.

Facility Regulation and Control↗
PubMed1985

The control of organics in drinking water in Canada and the United States (standards, legislation and practice).

Both the United States and Canada have a federal form of government, but approaches used in the two countries to ensure the safety of drinking water supplies differ. The Environmental Protection Agency currently enforces regulations for 10 organic chemicals (including 6 pesticides) under the Safe Drinking Water Act and provides advice on others through its health advisory program. Canada, however, does not have similar legislation, but rather provides health-related guidelines for 21 organic chemicals (including 16 pesticides) which are used by the provincial agencies responsible for drinking water supplies. Both countries are in the process of revising their standards and will include a variety of additional synthetic organic chemicals. Where possible, standards are set using a calculated acceptable daily intake usually derived from animal feeding experiments. Procedures for setting standards for carcinogens involve a blend of risk estimation coupled with consideration of the feasibility of reducing the risk in light of socio-economic factors. Most drinking water treatment plans in North America utilize 'conventional' treatment. Some now employ modifications in order to minimize trihalomethane formation. A few use aeration or granular activated carbon to remove synthetic organic chemicals.

Canada↗
PubMed2001

Assessment of recent ozone short-term epidemiologic studies.

The U.S. Environmental Protection Agency (EPA) revised the National Ambient Air Quality Standards (NAAQS) for ozone in 1997 based largely on short-term ozone studies published up to 1995. The U.S. EPA's conclusions must now be updated because (1) the agency did not consider many new studies published since 1995 and (2) the agency did not critically review the studies published before 1995 (i.e., it accepted the stated conclusions). In this article, we examine many recently published short-term ozone studies including 17 hospital admissions studies, 10 mortality studies, and 6 summer-camp studies. Almost all of these studies reported a significant association between ambient levels of ozone and adverse health effects. However, on close examination, it is apparent that there are mixed findings from one study to another and even within the results of a single study. Moreover, questionable statistical analyses and failure to consider confounders make a number of the reported findings doubtful and even negative.

Acute Disease↗
PubMed1993

A survey of EPA/OPP and open literature data on selected pesticide chemicals tested for mutagenicity. I. Introduction and first ten chemicals.

Parties interested in registering a pesticide chemical with the U.S. Environmental Protection Agency's (USEPA's) Office of Pesticide Programs (OPP) must submit toxicity information to support the registration. Mutagenicity data are a part of the required information that must be submitted. This information is available to the public via Freedom of Information requests to the OPP. However, it is felt that this information would be more effectively and widely disseminated if presented in a published medium. Beginning with this publication, sets of mutagenicity data on pesticide chemicals will be periodically published in the Genetic Activity Profile (GAP) format. In addition, mutagenicity data extracted from the currently available open literature is also presented to provide a more complete database and to allow comparisons between the OPP-submitted data and other publicly available information.

Animals↗