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PubMed1999

Assessment of the U.S. Environmental Protection Agency methods for identification of hazards to developing organisms, Part II: The developmental toxicity testing guideline.

BACKGROUND: The effects of toxins on developing animals depend not only on the nature of the chemical but also on the timing of exposure and assessment of outcomes. This complicates the task of regulatory agencies such as the U.S. Environmental Protection Agency (EPA), which must comply with the 1996 Food Quality Protection Act to ensure that their standards and policies protect infants and children from environmental toxins. For this task, the Agency relies heavily on scientific data obtained by manufacturers of industrial chemicals and pesticides following protocols collected under EPA's Health Effects Test Guidelines. METHODS AND RESULTS: This article reviews the protocols included in the EPA guidelines to assess developmental toxicity, which are required for food-use pesticides under the core testing battery. We reviewed these protocols on the basis of their adequacy for identifying hazards to infants and children. Our analysis found limitations in the protocols that hinder their potential for identifying developmental hazards. CONCLUSIONS: Methods that the EPA currently depends upon to identify developmental toxicity of chemicals have limitations that impede obtaining complete and reliable data on which to base regulatory decisions that protect children. Other methodological approaches need to be explored as alternatives or supplements to the current protocols. Until more accurate testing protocols become available, it may well be necessary under existing laws to employ safety factors that are more protective of the health of children at all stages of development.

Animals↗
PubMed1989

Environmental protection and its trends in developing countries.

On instances of some worldwide problems of environmental protection, the authors refer to the fact, that a target of industrial countries is to help to the developing countries. Mainly it means an aim in such sense, that the dangerous failures and faults which happened in the past, should not be repeated as a consequence of temporaneous economical problems in the Third World. In the long run it is a common interest of all and certainly a sufficient motivation of a commonly coordinated effort in this field. It is at most desirable, that all developing projects, from a simple water supply to the integrated developing concepts, for example eco-agriculture projects, correspond with the national interests as well as with the specific requirements of environmental control.

Developing Countries↗
PubMed2002

US Environmental Protection Agency Method 326.0, a new method for monitoring inorganic oxyhalides and optimization of the postcolumn derivatization for the selective determination of trace levels of bromate.

The development of US Environmental Protection Agency (EPA) Method 317.0 provided a more sensitive, acceptable alternative to EPA Method 300.1 to be proposed as one of the recommended compliance monitoring methods for Stage II of the Disinfectants/Disinfection By-Products (DBP) Rule. This work was initiated to evaluate other postcolumn reagents (PCRs) that might be utilized to provide an additional, alternative method in order to augment compliance monitoring flexibility for inorganic oxyhalide DBP anions. Modifications of the method reported by Salhi and von Gunten, which included adjustment and optimization of flow-rates, reaction temperature, and delivery of the PCR, improved the method performance. Method 326.0 incorporates an acidic solution of potassium iodide containing catalytic amounts of molybdenum(VI) as the PCR and provides acceptable precision and accuracy for all analytes and a postcolumn bromate detection limit in reagent water of 0.17 microg/l.

Bromates↗
PubMed2001

Review of the methods of the US Environmental Protection Agency for bromate determination and validation of method 317.0 for disinfection by-product anions and low-level bromate.

In recent years several methods have been published by the United States Environmental Protection Agency (EPA) which specify bromate as a target analyte. The first of these was EPA Method 300.0. As technological improvements in ion chromatographic hardware have evolved and new detection techniques have been designed, method detection limits for bromate have been reduced and additional procedures have been written, including EPA Method 300.1, 321.8 and, most recently, EPA Method 317.0. An overview of the evolution of these bromate methods since 1989 is presented. The focus is specific to each of these respective procedures, highlighting method strengths, weaknesses, and addressing how these methods fit into EPA's regulatory agenda. In addition, performance data are presented detailing the joint EPA/American Society for Testing and Materials multilaboratory validation of EPA Method 317.0 for disinfection by-product anions and low-level bromate.

Anions↗
PubMed1989

U.S. Environmental Protection Agency procedures and policies to estimate risk of injury to the male reproductive system.

Risk assessment, as defined by the National Academy of Sciences in 1983, is comprised by the following components: hazard identification, dose-response assessment, exposure assessment, and risk characterization. The U.S. Environmental Protection Agency (EPA) has developed risk assessment guidelines which follow the NAS format for Program Offices to follow in evaluating the potential adverse effects of environmental agents on humans. Guidelines have been published in the Federal Register on cancer, mutagenicity, developmental toxicity, chemical mixtures, and exposure. Proposed guidelines are expected to be published shortly on female and male reproductive toxicity.

Animals↗
PubMed1996

Comparison of the recoveries of Escherichia coli and total coliforms from drinking water by the MI agar method and the U.S. Environmental Protection Agency-approved membrane filter method.

Drinking water regulations under the Final Coliform Rule require that total coliform-positive drinking water samples be examined for the presence of Escherichia coli or fecal coliforms. The current U.S. Environmental Protection Agency-approved membrane filter (MF) method for E. coli requires two media, an MF transfer, and a total incubation time of 28 h. A newly developed MF method, the MI agar method, containing indoxyl-beta-D-glucuronide and 4-methylumbelliferyl-beta-D-galactopyranoside for the simultaneous detection of E. coli and total coliforms, respectively, by means of their specific enzyme reactions, was compared with the approved method by the use of wastewater-spiked tap water samples. Overall, weighted analysis of variance (significance level, 0.05) showed that the new medium recoveries of total coliforms and E. coli were significantly higher than those of mEndo agar and nutrient agar plus MUG (4-methylumbelliferyl-beta-D-glucuronide), respectively, and the background counts were significantly lower than those of mEndo agar (< 5%). Generally, the tap water source, overall chlorine level, wastewater source, granular activated carbon treatment of the tap water, and method of grouping data by E. coli count for statistical analysis did not affect the performance of the new medium.

Agar↗
PubMed2000

Highly selective and efficient determination of US Environmental Protection Agency priority phenols employing solid-phase extraction and non-aqueous capillary electrophoresis.

Non-aqueous capillary electrophoresis has been used in the separation of a complete list of 26 priority phenols included in the 8041 US Environmental Protection Agency method and the 76/464/EEC European Union directive. A highly selective and efficient separation was obtained when the background electrolyte used was 150 mM ammonium acetate dissolved in N-methylformamide-acetonitrile (75:25). Solid-phase extraction was successfully assayed as an enrichment strategy for the analysis of low-concentration samples. A styrene-divinylbenzene functionalized cartridge provided excellent recoveries of phenols from water samples at neutral pH. The limits of quantification obtained permit the application of the proposed method to the determination of priority phenols in wastewater samples.

Electrophoresis, Capillary↗
PubMedDate not supplied

Environmental Protection Agency risk assessment--process and toxicologic pathology.

Risk assessment of a pesticide includes the identification of hazard, dose-response, exposure assessment, and risk characterization. Toxicology study reports undergo several levels of scientific and regulatory review in the Environmental Protection Agency's (EPA's) Office of Pesticide Programs. A Health Effects Division (HED) scientist reviews the reports. The resulting Data Evaluation Records are presented to several internal HED Peer Review committees to ensure consistency across chemicals in establishing which hazard end points to use when determining the reference dose and carcinogenicity potential for use in dietary and nondietary risk assessments. There may also be external reviews. The toxicologic pathologist can impact many steps in this process. The noncancer end points are just as important as the cancer end points when evaluating the hazard component of a pesticide. The toxicologic pathologist can assist in the hazard and risk characterization by being clear and concise, carefully defining terms and relating individual lesions to the animal, study, and database as a whole. The preceding will assist the HED in fulfilling EPA Administrator Carol Browner's guidance for risk characterizations that are transparent, clear, concise, and reasonable.

Animals↗
PubMed1981

Interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Interim final rule and interim final amendments to rules and request for comments.

The Environmental Protection Agency [EPA] has issued standards applicable to owners and operators of hazardous waste management facilities as required by the Resource Conservation and Recovery Act [RCRA]. One of these standards bans the disposal of most containerized liquid hazardous waste in landfills, effective November 19, 1981. As a result of reconsideration of this restriction, EPA is today promulgating an interim final rule to allow the disposal of small containers of liquid and solid hazardous waste in landfills provided that the wastes are placed in overpacked drums [lab packs] in the manner specified in today's rule. The purpose of today's rule is to provide an environmental sound disposal option for generators of small containers of hazardous wastes, such as laboratories.

Hospitals↗
PubMed2001

Environmental protection and economization of resources by electroorganic and electroenzymatic syntheses.

The electrochemical methodology is an intrinsically environmentally friendly technique. It is especially excellently suited for preventive environmental protection because the practically mass-free electrons are used as reagents. Therefore, it allows the production of organic compounds without the formation of ecologically critical waste which has to be disposed. In addition, toxic waste formation can be prevented by continuous in situ or two-step electrochemical regeneration of heavy metal redox reagents. By using solid polymer electrolytes (ion-exchange membranes), even the use of a supporting electrolyte can be avoided. Thus, product formation can take place in pure methanol without any other chemical present. The consumption of resources can be economized by generating high-value products on both electrodes, anode and cathode (paired electrosynthesis). In certain cases, the same product may be formed on the anode and the cathode (200%-cell). Finally, in electroenzymatic syntheses, two environmentally friendly methods can be combined for the regeneration of the cofactors or the prosthetic groups of redox enzymes.

Chemical Industry↗
PubMed2000

Health, safety and environmental protection in a biological research laboratory.

This manuscript summarizes the mandatory regulations for Health, safety and environmental protection (HSE) at the Novartis Forschungsinstitut-Vienna to ensure the safe and contained biological laboratory work especially with class II agents in the specialized biosafety level 2 (BL2) facilities available at this institute. These regulations apply to work practices conducted within these facilities; to special safe-containment features of these BL2 facilities; to containment and decontamination of biohazardous or potentially biohazardous materials of risk class II; and to the procedures in place to guarantee that these regulations are strictly carried out, and that only individuals with the appropriate training and approval have access to these facilities. The regulations governing BL2 facilities summarized here have been taken directly from CDC and NIH public documents; any special adaptations or additions to these regulations have been stated as such, in order to make these guidelines as transparent and nonredundant as possible.

Austria↗
PubMed2000

U.S. Environmental Protection Agency's revised guidelines for carcinogen risk assessment: evaluating a postulated mode of carcinogenic action in guiding dose-response extrapolation.

There are new opportunities to using data from molecular and cellular studies in order to bring together a fuller biological understanding of how chemicals induce neoplasia. In 1996, the Environmental Protection Agency (EPA) published a proposal to replace its 1986 Guidelines for Carcinogen Risk Assessment to take advantage of these new scientific advances in cancer biology. The analytical framework within the new guidelines focuses on an understanding of the mode of carcinogenic action. Mode of action data come into play in a couple of ways in these new guidelines. For example, such information can inform the dose-response relationship below the experimental observable range of tumours. Thus, mode of action data can be useful in establishing more appropriate guidance levels for environmental contaminants. It is the understanding of the biological processes that lead to tumour development along with the response data derived from experimental studies that can help discern the shape of the dose-response at low doses (linear vs. nonlinear). Because it is experimentally difficult to establish "true thresholds" from others with a nonlinear dose-response relationship, the proposed guidelines take a practical approach to depart from low-dose linear extrapolation procedures when there is sufficient experimental support for a mode of action consistent with nonlinear biological processes (e.g., tumours resulting from the disruption of normal physiological processes).

Animals↗
PubMed2003

Modifications to United States Environmental Protection Agency methods 1622 and 1623 for detection of Cryptosporidium oocysts and Giardia cysts in water.

Collaborative and in-house laboratory trials were conducted to evaluate Cryptosporidium oocyst and Giardia cyst recoveries from source and finished-water samples by utilizing the Filta-Max system and U.S. Environmental Protection Agency (EPA) methods 1622 and 1623. Collaborative trials with the Filta-Max system were conducted in accordance with manufacturer protocols for sample collection and processing. The mean oocyst recovery from seeded, filtered tap water was 48.4% +/- 11.8%, while the mean cyst recovery was 57.1% +/- 10.9%. Recovery percentages from raw source water samples ranged from 19.5 to 54.5% for oocysts and from 46.7 to 70.0% for cysts. When modifications were made in the elution and concentration steps to streamline the Filta-Max procedure, the mean percentages of recovery from filtered tap water were 40.2% +/- 16.3% for oocysts and 49.4% +/- 12.3% for cysts by the modified procedures, while matrix spike oocyst recovery percentages ranged from 2.1 to 36.5% and cyst recovery percentages ranged from 22.7 to 68.3%. Blinded matrix spike samples were analyzed quarterly as part of voluntary participation in the U.S. EPA protozoan performance evaluation program. A total of 15 blind samples were analyzed by using the Filta-Max system. The mean oocyst recovery percentages was 50.2% +/- 13.8%, while the mean cyst recovery percentages was 41.2% +/- 9.9%. As part of the quality assurance objectives of methods 1622 and 1623, reagent water samples were seeded with a predetermined number of Cryptosporidium oocysts and Giardia cysts. Mean recovery percentages of 45.4% +/- 11.1% and 61.3% +/- 3.8% were obtained for Cryptosporidium oocysts and Giardia cysts, respectively. These studies demonstrated that the Filta-Max system meets the acceptance criteria described in U.S. EPA methods 1622 and 1623.

Animals↗
PubMed2002

Universal screening method for the determination of US Environmental Protection Agency phenols at the lower ng l(-1) level in water samples by on-line solid-phase extraction-high-performance liquid chromatography-atmospheric pressure chemical ionization mass spectrometry within a single run.

The applicability of a previously optimized method for the analysis of the US Environmental Protection Agency (EPA) regulations phenols, based on on-line solid-phase extraction coupled to liquid chromatography with mass spectrometric (MS) detection in different matrix loaded water samples is demonstrated. The comprehensive optimization of the mobile phase conditions and their influence on the ionization process in atmospheric pressure ionization is described in detail. In particular, MS detection of the weakly acidic phenols such as phenol, monochlorinated phenols and methylated phenols requires the absence of acidic mobile phase modifiers and buffers. Thus lower retention times and slight peak broadening of the more acidic dinitrophenols are obtained if the entire range of EPA phenols is analyzed within a single chromatographic run. The figures of merit for the method were determined and the applicability to real water samples was investigated. Limits of detection for phenols ranging from 40 to 280 ng l(-1) and relative standard deviations below 8% in SCAN mode are obtained for all phenols if only 10-ml river water samples with low dissolved organic carbon (DOC 5 mg C l(-1) concentrations are preconcentrated. The method was used to detect 2-nitrophenol and 4-nitrophenol in river water samples in the lower ng l(-1) range. The analysis of highly matrix-loaded samples (DOC 210 mg C l(-1)) requires a reduced enrichment volume resulting in decreased sensitivity. Still the method is capable of reaching excellent detection limits which demonstrates its excellent suitability for screening analysis.

Atmospheric Pressure↗
PubMed1996

Culture variability associated with the U.S. Environmental Protection Agency Tuberculocidal Activity Test Method.

Tuberculosis continues to be a major world health threat. The etiologic agent is among the vegetative organisms most resistant to chemical disinfection. Tuberculocidal efficacy testing for regulatory approval of chemical germicides has evolved considerably over the past decade. A method currently in use is the Environmental Protection Agency Tuberculocidal Activity Test Method, a suspension test using a Mycobacterium bovis culture grown under specific conditions and stored frozen until used. Differing tuberculocidal label claims on products with similar formulations have raised questions concerning the equivalence of test suspensions prepared by different laboratories. Five M. bovis suspensions from laboratories currently performing this test were compared against a battery of three disinfectants at a single test site. A significant difference between test cultures was found, with two of the five exhibiting a significant difference from the other three and also from each other. There was a significant culture-by-disinfectant interaction, indicating that the five cultures did not respond in a consistent manner across the different disinfectants used. However, these differences were due to cultures that were not prepared in accordance with the standard procedure or otherwise did not meet the test suspension criteria. In addition, a 0.55% sodium hypochlorite solution was found to be a sensitive indicator of culture variability. These data reinforce the need to adhere to published procedures and guidelines when growing and preparing a tuberculocidal test suspension and shed light on the variables associated with this type of testing.

Base Sequence↗
PubMed2000

Eliminating the chlorite interference in US Environmental Protection Agency Method 317.0 permits analysis of trace bromate levels in all drinking water matrices.

A post-column reagent (PCR) method for bromate analysis in drinking water with a method detection limit (MDL) and method reporting limit (MRL) of 0.1 and 0.5 microg/l, respectively, has been developed by the United States Environmental Protection Agency (EPA) for future publication as EPA Method 317.0. The PCR method provides comparable results to the EPA's Selective Anion Concentration (SAC) method used to support the laboratory analysis of Information Collection Rule (ICR) low-level bromate samples and offers a simple, rugged, direct injection method with potential to be utilized as a compliance monitoring technique for all inorganic Disinfectants/Disinfection By-Products (D/DBPs). It has superior sensitivity for bromate compared to EPA Method 300.1, which was promulgated as the compliance monitoring method for bromate under Stage 1 of the D/DBP rule. This paper addresses elimination of the chlorite interference that was previously reported in finished waters from public water systems (PWSs) that employ chlorine dioxide as the disinfectant. An evaluation of Method 317.0 for the analysis of bromate in commercial bottled waters is also reported.

Bromates↗
PubMed2001

Indirect exposure assessment at the United States Environmental Protection Agency.

In the early 1980s, exposures and subsequent health impact assessments from contaminants emitted into the air from stationary sources focused on the inhalation pathway. This 'direct' pathway of exposure was thought to be the most critical pathway, as it is for many contaminants. However, by the latter 1980s, the focus at the Environmental Protection Agency (EPA) shifted to contaminants that would persist in the environment and could bioaccumulate up the food chain. Consumption of impacted food products, and other 'indirect' pathways of exposure, such as soil-related exposures, were shown to result in exposures that exceeded inhalation exposures by two to up to four orders of magnitude. A historical background of indirect exposure assessment at EPA is provided in this paper, followed by an overview of modeling methodologies commonly used in indirect exposure assessments. These methodologies are demonstrated on a contaminant of primary focus for indirect exposure impact, dioxins. Two examples are provided. In the first, an air-to-beef model validation exercise is described. In the second, an indirect exposure assessment on a municipal solid waste incinerator in Ohio conducted by the EPA is summarized. This incinerator emitted very large amounts of dioxin, more than any single source known to EPA. Models were used to predict the movement of dioxins from the stack to a nearby hypothetical farm, where individuals in the farm family were exposed to dioxins from consumption of home-produced beef and milk. The predicted lifetime cancer risk of 2.8 x 10(-4) based on these food pathways was used by EPA's Region 5 to initiate regulatory activity on this incinerator.

Agriculture↗