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St. Joseph teams up wih EPA for big energy savings.

U.S government to the rescue? An energy savings program with the U.S Environmental Protection Agency is saving big bucks for plenty of health care facilities around the country. A good example is St. Joseph Hospital in Lancaster, PA, which is saving an estimated $175,000 each year from new lighting fixtures alone. And that's just the beginning. Here's the story, plus details on how you can tap into this voluntary program.

Conservation of Energy Resources↗

A review and critique of the EPA's rationale for a fine particle standard.

I review the rationale for the Environmental Protection Agency's 1996 fine particle standard, which was based almost entirely on the epidemiological data with neither support from Toxicology nor understanding of mechanism. While many epidemiological papers available in 1996 reported associations between ambient particles and adverse effects on human health, many others did not and the evidence fell far short of supporting a causal association between particle mass concentration and human health. The literature appearing after 1996 further complicates the picture. The large studies that have appeared after 1996, such as National Mortality Morbidity and Air Pollution Study, and the reanalyses of the American Cancer Society II study, report risks that are substantially smaller than the risks reported in the 1996 Criteria Document and Staff Paper. Moreover, concerns about confounding by weather, temporal trends and co-pollutants remain unresolved. Other issues having to do with model choice have resurfaced as a result of reanalyses of critical data to address a glitch in a widely used software package for time-series epidemiology studies of air pollution. Finally, contemporary examples show that the results of observational epidemiology studies can be seriously biased, particularly when estimated risks are small, as is the case with studies of air pollution. The Agency has largely ignored these issues. I conclude that a particle mass standard is not defensible on the basis of a causal association between ambient particle mass and adverse effects on human health. Such a standard may be justifiable on the basis of the precautionary principle, however. The Agency could argue that the Science raises concerns about current levels of air pollution, and that reduction of ambient fine particulate matter mass, if it could be achieved without an increase in the level of the ultrafines, could have positive effects on human health. If the Agency justifies a particulate matter mass standard on these grounds then the debate over the form and level of the standard will, for all practical purposes, belong strictly in the Policy arena.

Air Pollution↗

From health-based to technology-based standards for hazardous air pollutants.

The Clean Air Act Amendments of 1990 represent a major shift in regulatory emphasis for toxic air pollutants. Recognizing the immediate public health benefits that can be gained from the application of currently available and affordable control technologies, Congress has abandoned its insistence that health risks should be the only consideration in establishing emissions standards. Previously excluded concerns about economic costs and technological feasibility will now determine the initial level of pollution control required of toxic air pollution sources. In exchange for reducing the stringency of emissions limits, the newly amended act extends the scope of regulation by listing 189 toxic substances that must be controlled over the next decade. This exchange of regulatory depth for breadth occurs against a history of reluctance by the Environmental Protection Agency to implement the original health-protective language of the Clean Air Act. It mirrors earlier compromises under the Clean Water Act and the Occupational Safety and Health Act.

Air Pollutants↗

Regulation of priority carcinogens and reproductive or developmental toxicants.

In California, 370 carcinogens and 112 reproductive/developmental toxicants have been identified as a result of the State's Safe Drinking Water and Toxic Enforcement Act of 1986. They include pesticides, solvents, metals, industrial intermediates, environmental mixtures, and reactive agents. Occupational, environmental, and consumer product exposures that involve these agents are regulated under the Act. At levels of concern, businesses must provide warnings for and limit discharges of those chemicals. The lists of chemicals were compiled following systematic review of published data, including technical reports from the U.S. Public Health Service--National Toxicology Program (NTP), and evaluation of recommendations from authoritative bodies such as the International Agency for Research on Cancer (IARC) and the U.S. Environmental Protection Agency (USEPA). Given the large number of chemicals that are carcinogens or reproductive/developmental toxicants, regulatory concerns should focus on those that have high potential for human exposure, e.g., widely distributed or easily absorbed solvents, metals, environmental mixtures, or reactive agents. In this paper, we present a list of 33 potential priority carcinogens and reproductive/developmental toxicants, including alcoholic beverages, asbestos, benzene, chlorinated solvents, formaldehyde, glycol ethers, lead, tobacco smoke, and toluene.

Animals↗

What to do at low doses: a bounding approach for economic analysis.

To quantify the health benefits of environmental policies, economists generally require estimates of the reduced probability of illness or death. For policies that reduce exposure to carcinogenic substances, these estimates traditionally have been obtained through the linear extrapolation of experimental dose-response data to low-exposure scenarios as described in the U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment (1986). In response to evolving scientific knowledge, EPA proposed revisions to the guidelines in 1996. Under the proposed revisions, dose-response relationships would not be estimated for carcinogens thought to exhibit nonlinear modes of action. Such a change in cancer-risk assessment methods and outputs will likely have serious consequences for how benefit-cost analyses of policies aimed at reducing cancer risks are conducted. Any tendency for reduced quantification of effects in environmental risk assessments, such as those contemplated in the revisions to EPA's cancer-risk assessment guidelines, impedes the ability of economic analysts to respond to increasing calls for benefit-cost analysis. This article examines the implications for benefit-cost analysis of carcinogenic exposures of the proposed changes to the 1986 Guidelines and proposes an approach for bounding dose-response relationships when no biologically based models are available. In spite of the more limited quantitative information provided in a carcinogen risk assessment under the proposed revisions to the guidelines, we argue that reasonable bounds on dose-response relationships can be estimated for low-level exposures to nonlinear carcinogens. This approach yields estimates of reduced illness for use in a benefit-cost analysis while incorporating evidence of nonlinearities in the dose-response relationship. As an illustration, the bounding approach is applied to the case of chloroform exposure.

Carcinogens↗

Safety guidelines for copper in water.

It is important for public health authorities to set a scientifically sound guideline value for the safe ingestion of copper in drinking water. To date, the principal health-based guideline values have been set by the US Environmental Protection Agency (1.3 mg Cu/L) and the World Health Organization (2.0 mg Cu/L). However, close examination of the data and assumptions used in the derivation of these values reveals a paucity of scientifically defensible information. Several international groups are now reviewing this issue, and others have begun epidemiologic studies that may provide useful copper exposure and toxicity data. Investigations of acute copper toxicity in human populations are most likely to affect future revisions of the guideline value for copper in drinking water.

Copper↗

Incorporating the 3Rs into regulatory scientific practices.

The Office of Prevention, Pesticides, and Toxic Substances (OPPTS) of the US Environmental Protection Agency (EPA) grapples with testing issues on a daily basis. In this discussion, the current practices within OPPTS that relate to refining, reducing, and replacing (the 3Rs of) animal use are explained, based on the authors' experience. Pertinent background about EPA and OPPTS is first described, and then some broad opportunities for implementing the 3Rs are reviewed. Finally, information about how the programs in OPPTS are making progress with regard to the 3Rs is presented.

Animal Testing Alternatives↗

[The evaluation of occupational exposure to carcinogenic substances: limit values and risk assessments].

Considering that nowadays there is no unanimity about the possibility of adopting environmental and/or biological limit values in occupational exposure to carcinogens, some aspects are discussed about the mechanism of action of carcinogens, their metabolism and problems deriving from the possible multiple exposures, interactions and speciation of the different compounds. After the analysis of the results obtained by means of two different approaches by the American Conference of Governmental Industrial Hygienist and the Environmental Protection Agency of the United States, the authors examine some aspects of the qualitative and as far as possible quantitative comparison for the 16 substances included in both lists and they discuss how the mathematical models are used in the process of carcinogenic risk evaluation. Finally, it is considered the possible application even in occupational carcinogenesis of a model such as the one of the EPA.

Carcinogens↗

Vinyl chloride: a case study of data suppression and misrepresentation.

When the U.S. Environmental Protection Agency (EPA) finalized its 2000 update of the toxicological effects of vinyl chloride (VC), it was concerned with two issues: the classification of VC as a carcinogen and the numerical estimate of its potency. In this commentary we describe how the U.S. EPA review of VC toxicology, which was drafted with substantial input from the chemical industry, weakened safeguards on both points. First, the assessment down-plays risks from all cancer sites other than the liver. Second, the estimate of cancer potency was reduced 10-fold from values previously used for environmental decision making, a finding that reduces the cost and extent of pollution reduction and cleanup measures. We suggest that this assessment reflects discredited scientific practices and recommend that the U.S. EPA reverse its trend toward ever-increasing collaborations with the regulated industries when generating scientific reviews and risk assessments.

Animals↗

A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studies.

In the early 1980's both the Environmental Protection Agency and the Food and Drug Administration were receiving studies on the products that they regulate that were unscientifically sound, some even being fraudulent. Studies were being submitted that had not been done under sound scientific practice; data were missing; necessary documentation to reconstruct the study, also known as an audit trail, was not in place, it was this evidence that lead to the Good Laboratory Practice Standards (GLPs) being codified and becoming regulation. The GLPs were meant to assure that studies submitted to the agencies for the registration of products for which they were responsible would protect the environment, and, the safety and health of the public.

Animals↗

Communicating air quality information: experimental evaluation of alternative formats.

A long-running effort in environmental communication is daily publication of a report on local air pollution in many American newspapers based on the Pollutant Standards Index (PSI). A 1998 proposal by the U.S. Environmental Protection Agency (U.S. EPA) to change the PSI prompted a survey experiment with 1,100 adults in Philadelphia, evaluating the proposed change's ability to better inform the populace. The effects of exposure to the old and new versions of the PSI, as well as health cautions and information about groups sensitive to air pollution, were compared with evaluation criteria suggested by Weinstein and Sandman (1993). Sample respondents had strong baseline concerns about air pollution. Descriptors of air quality (e.g., "good; " "unhealthy") were difficult to discriminate, particularly in the New format. Concern rose as hypothetical air pollution levels rose, but the New format (as well as PSI versions without health cautions or sensitive-group information) evoked a sharp discontinuity in concern between below- and above-standard pollution levels. Both Old and New formats reduced concern relative to no provision of PSI information at all, but the New format reduced concern significantly more than the Old version. No PSI format did particularly well at increasing knowledge of air pollution or decreasing intentions to be active outdoors during high pollution, contrary to the agency's aim. Although U.S. EPA has since adopted the new proposal as a national "Air Quality Index" requirement, the experiment's results illuminate the strengths and limitations of the new PSI as a means of informing citizens and motivating them to protect themselves.

Air Pollution↗

Performance of on-line chemical property estimation methods with TSCA premanufacture notice chemicals.

CHEMEST is an interactive on-line system for estimating chemical properties important in environmental fate assessment. In 1988 we described an extensive validation study of CHEMEST. That study showed that for existing chemicals, most properties could be estimated with accuracy sufficient for screening-level assessment. Reported here are the results of a study of system performance with "new" chemicals, for which Premanufacture Notices (PMNs) must be submitted under the Toxic Substances Control Act. Measured values of key properties were retrieved for more than 300 PMN chemicals having discrete structures, which represented the majority of notices with submitted data that were received by the U.S. Environmental Protection Agency during the period 1979-1990. The measured values were compared to estimates from AUTOCHEM, an automated version of CHEMEST. Errors were generally greater than those for existing chemicals, as expected. Water solubility and the octanol/water partition coefficient (Kow) were estimated with acceptable accuracy, but the results for melting point and boiling point indicate that additional effort is needed to improve the estimation methods.

Chemical Industry↗

Endocrine disrupters. Panel cautiously confirms low-dose effects.

Faced with conflicting results from studies of the effects of small amounts of hormonelike chemicals in the environment, the Environmental Protection Agency enlisted the help of an expert panel, which met earlier this month to conduct an extensive review of the data. The panel concluded that estrogenic chemicals can cause biological effects in lab animals at levels below those normally found to be safe--which runs counter to the conventional wisdom in toxicology. But the implications for human health are unclear.

Animals↗

The role of mode of action studies in extrapolating to human risks in toxicology.

The US Environmental Protection Agency (EPA) in 1999 issued draft guidelines on carcinogen risk assessment, which included the use mode of action information in the risk assessment process. We have used the five stages of induction of toxicity as described by Aldridge to illustrate in the case of two drugs, tamoxifen and NTBC, how mode of action information played a key role in assessing the risk of cancer and target organ toxicity, respectively.

Animals↗

Method for estimating the human and environmental exposure potential of chemicals having designated uses.

This paper describes a methodology that was designed to assist the Environmental Protection Agency in setting priorities for regulating chemicals in accordance with requirements of the Toxic Substances Control Act by indicating the extent of exposure potentially associated with a particular use of a chemical. Development and application of the methodology to actual chemical uses proceeded in four stages: (1) development of an exposure classification scheme, (2) development of a chemical use list, (3) assignment of exposure category scores to chemical uses, and (4) merging of exposure scores into ranked groups, creating the Index of Exposure. The purpose of the Index was to identify those chemical uses having the greatest potential for human and environmental exposure. Theoretically, the objectivity of the scoring methodology is such that, given the same data for a chemical use, different scorers will be able to arrive at the same exposure score for that use.

Environmental Exposure↗

Development of an eight-hour occupational exposure limit for beryllium.

This article recommends an 8-hour occupational exposure limit (OEL) for beryllium. It responds to growing concerns about the continuing incidence of chronic beryllium disease despite the long-standing OEL for beryllium: 2 micrograms of beryllium per cubic meter of air (microgram/m3), 8-hour time-weighted average (TWA). Current 8-hour TWA beryllium OELs are not based on chronic beryllium disease toxicology and an increasing number of studies report incidence of chronic beryllium disease at exposure levels apparently below 2 micrograms/m3. The experience of the beryllium-exposed population of Lorain, Ohio, in the late 1940s, and the ambient air regulatory standards derived from that event provide evidence that establishing a protective level is possible. These levels are used as the basis for a new recommended beryllium exposure standard. A correspondingly protective 8-hour TWA level of 0.1 microgram/m3 has been derived, which, for commonly encountered workplace conditions (in terms of geometric standard deviation and percent-compliance), should provide long-term mean exposure protection comparable to that received by the unaffected Lorain subpopulation and provided by the Environmental Protection Agency (EPA) ambient standard. It is concluded that an exposure limit of 0.1 microgram/m3 combined with exposure monitoring to assure a high rate of day-to-day compliance would provide better control of both long-term mean exposure levels and short-term levels than do current occupational exposure limits. The health data available, while certainly not conclusive, support further reductions in exposure levels to help minimize the incidence of chronic beryllium disease.

Air Pollutants, Occupational↗

Long-term relationships between SO2 and NOx emissions and SO4(2-) and NO3- concentration in bulk deposition at the Hubbard Brook Experimental Forest, NH.

A highly significant second-order polynomial relation between SO(2) emissions and SO(4)(2-) concentrations during 1970-2000 (r(2)= 0.80, p= <0.001), and a linear relation between NO(x) and NO(3)(-) concentrations during 1991-2000 (r(2)= 0.67, p= 0.004) in bulk precipitation were found for the Hubbard Brook Experimental Forest, NH based on emissions from a 24 h, back-trajectory determined source area. Earlier periods (1965-1980) for SO(2)ratio SO(4)(2-) and longer periods (1965-2000) for NO(x)ratio NO(3)(-) had poorer linear relations, r(2)= 0.03, p= 0.51 and r(2)= 0.22, p= 0.004, respectively. Methodology by the US Environmental Protection Agency for calculating emissions data during this period has changed significantly and frequently, making trend analysis difficult. Given the large potential for errors in estimating emissions and to a lesser extent, deposition, the robust relations between SO(2) emissions and SO(4)(2-) concentrations in bulk precipitation at the Hubbard Brook Experimental Forest show that careful, long-term measurements from a single monitoring site can provide sound and reasonable data on trends in air pollution.

Acid Rain↗

Separation and detection of three aryltins by capillary electrophoresis-UV/VIS diode array.

The trialkyltins and triphenyltins have widespread application as fungicides, antifouling coatings for porous surfaces, herbicides, insecticides, and generic biocides. Due to the varied toxicity of each species of organotins, it is important that methods address the speciation of the organotins. Traditional methods call for the hydrolysis and subsequent derivatization of the organotins before analysis. These methods can be time consuming, derivatization can be incomplete, and high levels of background interference produce difficulties in identification and quantitation. The U.S. Environmental Protection Agency's (U.S. EPA) current methods do not address the speciation of organotins; instead they only analyze for total tin. It is important, because of the differing levels of toxicity of the various congeners of organotins, to speciate them from each other and inorganic tin. The research reported in this paper addresses the use of CE with UV/VIS diode-array detection to separate and detect three phenyltins (i.e., tri-, di-, and mono-), without the need to either derivatize or complex them.

Electrophoresis, Capillary↗