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PubMed1991

Disinfectant testing in the USA.

The federally mandated registration of disinfectants with the United States Environmental Protection Agency (EPA) requires the submission of efficacy test data obtained with the accepted methods of the Association of Official Analytical Chemists (AOAC). These include qualitative suspension tests for bacteria and fungi and carrier tests with use-dilutions for bactericidal, mycobactericidal and sporicidal activity. There is no AOAC method for virucides, and the present methods set forth by the American Society for Testing and Materials (ASTM) and the EPA are under scrutiny by the scientific community. The AOAC use-dilution test was challenged by the users, and two collaborative studies by the EPA and the AOAC did not resolve all questions. A new, quantitative supension test was proposed. The AOAC mycobactericial carrier test was found to be deficient for testing glutaraldehydes; an updated version and a new quantitative suspension test have been accepted by the EPA for registration. As a result, different glutaraldehyde preparations carry different label claims which are confusing to the consumer. National and international standardization of testing is desirable.

Chemistry Techniques, Analytical↗
PubMed2006

Analysis of physical and chemical parameters of bottled drinking water.

Seventeen different brands of bottled drinking water, collected from different retail shops in Amritsar, were analyzed for different physical and chemical parameters to ascertain their compliability with the prescribed/recommended limits of the World Heath Organization (WHO) and the United States Environmental Protection Agency (USEPA). It was found that the majority of the brands tested were over-treated. Lower values of hardness, total dissolved solids (TDS) and conductance than the prescribed limits of WHO showed that water was deficient in essential minerals. Minerals like magnesium, potassium, calcium and fluoride were present in some cases in such a low concentration that water seemed to be as good as distilled water. Samples showing fluoride lesser than 0.5 mg/l warranted additional sources of fluoride for the people consuming only bottled water for drinking purposes. Zero values for chlorine demand as shown by all the bottled water samples showed that water samples were safe from micro-organisms. In case of heavy metals, only lead had been found to be greater than the limit of 0.015 mg/l as prescribed by WHO and USEPA, in seven out of 17 samples. Lead even at such a low concentration can pose a great health hazard.

Calcium↗
PubMed1985

Products liability issues in school asbestos litigation.

The hazards posed by deteriorating friable asbestos in the nation's schools are causing serious concerns for public health officials, school boards, parents and school employees. Reports by both the Environmental Protection Agency and the U.S. Attorney General's Office agree that both school children and school employees stand a substantially increased risk of contracting some form of asbestos-related disease as a result of exposure to deteriorating asbestos materials in school buildings. School systems plagued by the asbestos hazards are now filing suits against asbestos manufacturers alleging causes of action in breach of warranty, negligence and strict products liability in tort. Some plaintiffs in school asbestos litigation seek to recover the costs of EPA-mandated asbestos inspection and abatement programs which have already been completed. Still others request injunctions to compel the manufacturers themselves to conduct inspections and finance abatement. This Note examines the school asbestos situation from a legal perspective and focuses primarily on whether the schools' claims should be considered as economic losses or as property damage. It examines the impact of statutes of limitations on these cases under both contract and tort theories. The Note argues that school asbestos claims should be decided under a strict products liability standard.

Adult↗
PubMedDate not supplied

FIFRA-88, GLP, and QA: pesticide registration.

The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has decreased the number of pesticide registrations in the United States. Subsequent implementation of the U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased costs of maintaining these registrations. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) maintains approximately 30 Section 3 (federal) or Section 24c (state) vertebrate pesticide registrations for the Wildlife Services (WS) program to control wild mammals and birds that damage crops, impact endangered species, or pose human health risks. Under FIFRA-88, APHIS summarized, performed, and submitted or gained waivers for > 500 studies requested by the U.S. EPA to assess potential hazards/effects of these pesticides. A summary of FIFRA-88 milestones for registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient (AI) in a "low-volume, minor-use" avicide (DRC-1339, Starlicide), is used to illustrate GLP/QA/animal welfare issues involved in this process. Trends in the development of new pesticides and veterinary drugs are compared to provide some perspectives on future career paths for QA professionals.

Animal Welfare↗
PubMed1994

QAU verification: Ricerca's approach to EPA requirements for specimen disposition.

The U.S. Environmental Protection Agency (EPA) Federal Insecticide. Fungicide and Rodenticide Act and Toxic Substance Control Act Standards issued in 1989 presented a new task for the Quality Assurance Unit (QAU). Sections .190 and .195 of these Good Laboratory Practice (GLP) Standards require "quality assurance verification" prior to the disposal of certain specimens. These include "specimens from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids." QAU involvement in the specimen disposition process was a new concept. Other GLP Standards required specimen retention only as long as the quality of the preparation afforded evaluation: the QAU was not included in the procedure. The QAU verification step was included by the EPA to ensure that disposal of the prescribed specimens would not compromise the integrity of the study. A procedure to address verification of specimen disposition as required by the EPA GLP Standards has been implemented by Ricerca's QAU. This presentation provides a description of this approach to QAU verification.

Documentation↗
PubMed2005

Potential interference bias in ozone standard compliance monitoring.

The U.S. Environmental Protection Agency has established a federal reference method (FRM) for ozone (O3) and allowed for designation of federal equivalent methods (FEMs). However, the ethylene-chemiluminescence FRM for O3 has been replaced by the UV photometric FEM by most state and local monitoring agencies because of its relative ease of operation. Accumulating evidence indicates that the FEM is prone to bias under the hot, humid, and stagnant conditions conducive to high O3 formation. This bias may lead to overreporting hourly O3 concentrations by as much as 20-40 ppb. Measurement bias is caused by contamination of the O3 scrubber, a problem that is not detected by dry air calibration. An adequate wet test has not been codified, although a procedure has been proposed for agency consideration. This paper includes documentation of laboratory tests quantifying specific interferant responses, collocated ambient FRM/FEM monitoring results, and smog chamber comparisons of the FRM and FEMs with alternative scrubber designs. As the numbers of reports on monitor interferences have grown, interested parties have called for agency recognition and correction of these biases.

Air Pollutants, Occupational↗
PubMed2004

Commentary: setting aside tradition when dealing with endocrine disruptors.

In 1996, the US Congress directed the Environmental Protection Agency to produce screens and assays to detect estrogenic and other endocrine-disrupting chemicals in food and water. To date, there are none. Years have been wasted in attempts to utilize traditional toxicological approaches to solve the problem, when in retrospect, it is now apparent that the delay in part stems from the reluctance to attack the problem with entirely new approaches. To develop new testing protocols, it is necessary to set aside much of the dogma of toxicology and to begin again with open minds. A few pertinent examples are provided concerning what has been overlooked and what needs to be done. In particular, it is necessary to give close attention to the selection of animal strain and diet, factors that were only loosely controlled historically when one takes into consideration what has been learned in the last decade. Vast numbers of animals have been sacrificed, and more will be sacrificed, in futile attempts to validate assays and to develop safety standards unless knowledge gained over the past decade concerning the sensitivity and complexity of the endocrine system is taken into consideration.

Animal Testing Alternatives↗
PubMed2006

Effect of soil depth and texture on fecal bacteria removal from septic effluents.

This study evaluated the effectiveness of soils with different texture and depth to treat fecal bacteria eluted from a house-hold septic effluent. The assessments were accomplished by leaching undisturbed soil monoliths of 30, 45, and 60cm thickness and 25cm in diameter, representing the four different textural groups and hydraulic loadings recommended by the Kentucky Health Department, with domestic wastewater effluent collected regularly from a house-hold septic system. Eluent concentrations were monitored daily over a 15 day period for fecal coliform and fecal streptococci concentrations. The results of the study indicate an alarming frequency of failure to comply with United States Environmental Protection Agency (USEPA) criteria for depth to groundwater, when using a 30 cm vertical separation distance between the bottom of the drain-field and a limiting soil interface. The treatment performance was especially poor in coarse-textured soils. Although biomat development over time is expected to improve treatment, the high influent levels of fecal bacteria pose great concerns for surface and groundwater contamination. Fine-textured soils generally provided better treatment efficiency and more consistent compliance with EPA standards. Treatment efficiency and compliance usually improved with increasing soil depth, with the 60cm thickness providing the most consistent performance and compliance with maximum discharge limit (MDL) requirements. The findings of this study document a general inadequacy of the 30cm vertical separation distance to provide effective treatment of septic effluents in Kentucky soils, particularly in coarse-textured soils. Considering that increasing the soil depth thickness may be impractical in many marginal soils, complementary or alternative treatment technologies should be adopted to improve treatment efficiency and prevent further deterioration of the quality of water resources.

Bacteria↗
PubMed1993

Acid Rain Program: general provisions and permits, allowance system, continuous emissions monitoring, excess emissions and administrative appeals--EPA. Final rule.

Title IV of the Clean Air Act (the Act), as amended November 15, 1990, requires the Environmental Protection Agency (EPA or Agency) to establish an Acid Rain Program to reduce the adverse effects of acidic deposition. To implement this statutory mandate, the Acid Rain Program requirements will be codified in seven regulations. This action delineates all or portions of five final regulations that were initially proposed December 3, 1991: General Provisions and Permits; the Allowance System; Continuous Emissions Monitoring; Excess Emissions Penalties; and Administrative Appeals. (The administrative appeals procedures were originally proposed as a subpart of the permits rule; EPA has decided to remove it from part 72 and place it in a separate part 78.) In addition to the final rules, this action includes a brief overview of the acid rain problem, summaries of major provisions of the proposed rules, the public's comments on these proposals, and summaries of the major changes that have been made in this final rule. DATES: These rules become effective February 10, 1993. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 10, 1993.

Acid Rain↗
PubMed1990

Airborne asbestos in public buildings.

The U.S. Environmental Protection Agency sampled air in 49 government-owned buildings (six buildings with no asbestos-containing material, six buildings with asbestos-containing material in generally good condition, and 37 buildings with damaged asbestos-containing material). This is the most comprehensive study to date of airborne asbestos levels in U.S. public buildings during normal building activities. The air outside each building was also sampled. Air samples were analyzed by transmission electron microscopy using a direct transfer preparation technique. The results show an increasing trend in average airborne asbestos levels; outdoor levels are lowest and levels in buildings with damaged asbestos-containing material are highest. However, the measured levels and the differences between indoors and outdoors and between building categories are small in absolute magnitude. Comparable studies from Canada and the UK, although differing in their estimated concentrations, also conclude that while airborne asbestos levels may be elevated in buildings that contain asbestos, levels are generally low. This conclusion does not eliminate the possibility of higher airborne asbestos levels during maintenance or renovation that disturbs the asbestos-containing material.

Air Pollutants↗
PubMed2002

Sampling frequency guidance for ambient air toxics monitoring.

The U.S. Environmental Protection Agency (EPA) is in the process of designing a national network to monitor hazardous air pollutants (HAPs), also known as air toxics. The purposes of the expanded monitoring are to (1) characterize ambient concentrations in representative areas; (2) provide data to support and evaluate dispersion and receptor models; and (3) establish trends and evaluate the effectiveness of HAP emission reduction strategies. Existing air toxics data, in the form of an archive compiled by EPA's Office of Air Quality Planning and Standards (OAQPS), are used in this paper to examine the relationship between estimated annual average (AA) HAP concentrations and their associated variability. The goal is to assess the accuracy, or bias and precision, with which the AA can be estimated as a function of ambient concentration levels and sampling frequency. The results suggest that, for several air toxics, a sampling schedule of 1 in 3 days (1:3) or 1:6 days maybe appropriate for meeting some of the general objectives of the national network, with the more intense sampling rate being recommended for areas expected to exhibit relatively high ambient levels.

Air Pollutants↗
PubMedDate not supplied

Enumeration procedure for monitoring test microbe populations on inoculated carriers in AOAC use-dilution methods.

The AOAC Use-Dilution methods do not provide procedures to enumerate the test microbe on stainless steel carriers (penicylinders) or guidance on the expected target populations of the test microbe (i.e., a performance standard). This report describes the procedures used by the U.S. Environmental Protection Agency to enumerate the test microbe (carrier counts) associated with conducting the Use-Dilution method with Staphylococcus aureus (Method 955.15) and Pseudomonas aeruginosa (Method 964.02) and the examination of historical data. The carrier count procedure involves the random selection of carriers, shearing bacterial cells from the carrier surface through sonication, and plating of serially diluted inoculum on trypticase soy agar. For each Use-Dilution test conducted, the official AOAC method was strictly followed for carrier preparation, culture initiation, test culture preparation, and carrier inoculation steps. Carrier count data from 78 Use-Dilution tests conducted over a 6-year period were compiled and analyzed. A mean carrier count of 6.6 logs (approximately 4.0 x 10(6) colony-forming units/carrier) was calculated for both S. aureus and P. aeruginosa. Of the mean values, 95% fell within +/- 2 repeatability standard deviations. The enumeration procedure and target carrier counts are desirable for standardizing the Use-Dilution methods, increasing their reproducibility, and ensuring the quality of the data.

Colony Count, Microbial↗
PubMed2006

Evaluation and recommendation of sensitivity analysis methods for application to Stochastic Human Exposure and Dose Simulation models.

Sensitivity analyses of exposure or risk models can help identify the most significant factors to aid in risk management or to prioritize additional research to reduce uncertainty in the estimates. However, sensitivity analysis is challenged by non-linearity, interactions between inputs, and multiple days or time scales. Selected sensitivity analysis methods are evaluated with respect to their applicability to human exposure models with such features using a testbed. The testbed is a simplified version of a US Environmental Protection Agency's Stochastic Human Exposure and Dose Simulation (SHEDS) model. The methods evaluated include the Pearson and Spearman correlation, sample and rank regression, analysis of variance, Fourier amplitude sensitivity test (FAST), and Sobol's method. The first five methods are known as "sampling-based" techniques, wheras the latter two methods are known as "variance-based" techniques. The main objective of the test cases was to identify the main and total contributions of individual inputs to the output variance. Sobol's method and FAST directly quantified these measures of sensitivity. Results show that sensitivity of an input typically changed when evaluated under different time scales (e.g., daily versus monthly). All methods provided similar insights regarding less important inputs; however, Sobol's method and FAST provided more robust insights with respect to sensitivity of important inputs compared to the sampling-based techniques. Thus, the sampling-based methods can be used in a screening step to identify unimportant inputs, followed by application of more computationally intensive refined methods to a smaller set of inputs. The implications of time variation in sensitivity results for risk management are briefly discussed.

Analysis of Variance↗
PubMed1997

Multimedia benchmarking analysis for three risk assessment models: RESRAD, MMSOILS, and MEPAS.

This paper is one in a series that describes results of a benchmarking analysis initiated by the Department of Energy (DOE) and the United States Environmental Protection Agency (EPA). An overview of the study is provided in a companion paper by Laniak et al. presented in this journal issue. The three models used in the study--RESRAD (DOE), MMSOILS (EPA), and MEPAS (DOE)--represent analytically-based tools that are used by the respective agencies for performing human exposure and health risk assessments. Both single media and multimedia benchmarking scenarios were developed and executed. In this paper, the multimedia scenario is examined. That scenario consists of a hypothetical landfill that initially contained uranium-238 and methylene chloride. The multimedia models predict the fate of these contaminants, plus the progeny of uranium-238, through the unsaturated zone, saturated zone, surface water, and atmosphere. Carcinogenic risks are calculated from exposure to the contaminants via multiple pathways. Results of the tests show that differences in model endpoint estimates arise from both differences in the models' mathematical formulations and assumptions related to the implementation of the scenarios.

Air Pollutants, Radioactive↗
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↗
PubMed1997

Risk assessment as a management tool used to assess the effect of pesticide use in an irrigation system, situated in a semi-desert region.

A preliminary study undertaken by the CSIR in July 1993 on the health effects of aerial crop spraying of pesticides in the Vaalharts irrigation area in South Africa indicated that potential health risks could exist for the inhabitants of this area. An extensive scientific health risk assessment and epidemiological study to determine the actual health risks, is very expensive and requires medical and financial justification. The aim of this study was to develop a theoretical health risk model, which could be used as a predictive tool to determine as accurately as possible from the data available if a complete scientific health risk assessment study is justified. The actual amounts of pesticides sold in the Vaalharts area by two major pesticide manufacturers were used to perform a theoretical health risk assessment. The risks were assessed by making use of RISK*ASSISTANT, a computer modeling system and chemical database. The United States Environmental Protection Agency's (EPA) health risk model was applied to the data to identify the hazards, assess the exposures and dose response, and characterize the risks. Three exposure scenarios, namely, the ingestion of food and water and the inhalation of air were evaluated. The method used to calculate the risks varied according to the type of health hazard and the results were characterized accordingly. The acute health effects due to exposure to pesticides are well known and the risks are easy to determine. However, the risks associated with chronic health hazards were more difficult to calculate. For this reason a ranking model was developed which made use ofa point scoring system. This model highlights those pesticides which have the greatest possibility of causing chronic health effects. From the results it can be concluded that very large amounts of pesticides are used in the Vaalharts area and that the community might be at risk to chronic health effects. Although the theoretical health risk assessment model was successfully used in this study, its effectiveness as a predictive tool still has to be proven by a complete scientific study.

Air Pollution↗
PubMed2002

Runoff of trifluralin, metolachlor, and metribuzin from a clay loam soil of Louisiana.

Trifluralin[2,6-dinitro-N,N-dipropyl-4-(trifluormethyl)benzenamine], metolachlor[2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl) acetamide] and metribuzin[4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)one] were applied as pre-emergent herbicides to soybean plots in Louisiana (LA) at the rate of 1683 g/ha, 2759 g/ha and 609 g/ha, respectively. The concentrations of trifluralin in the runoff water ranged between 0.09 ng/mL and 0.02 ng/mL, which is lower than the 2 ng/mL US Environmental Protection Agency (EPA) advisory level for trifuralin in drinking water. Metolachlor concentrations in the runoff water ranged from 9.0 ng/mL to 221.5 ng/mL, which is both lower and higher than the 175 ng/mL EPA advisory level for metolachlor. Similarly, metribuzin concentrations in the runoff water ranged between 1.5 ng/mL and 56.2 ng/mL, which is also lower and higher than the 10 ng/mL EPA advisory level for metribuzin. Accordingly, from the field plots located on a Commerce clay loam soil in LA, although the concentration of trifluralin in runoff water were substantially lower than the EPA advisory level, metolachlor and metribuzin concentrations are likely to exceed the EPA advisory levels early on in the application season with a subsequent rapid decrease to safe levels. The total loss of trifluralin in runoff water was 0.005% of the applied amount over an 89 day period after application. The total loss of metolachlor and metribuzin in the runoff water was 4.67% and 5.36% of the applied amount, respectively, over a 22 day period after application. As such, there was almost no movement of trifluralin in the runoff water, whereas metolachlor and metribuzin were much more easily moved.

Acetamides↗
PubMed2002

Starlink corn: a risk analysis.

Modern biotechnology has dramatically increased our ability to alter the agronomic traits of plants. Among the novel traits that biotechnology has made available, an important group includes Bacillus thuringiensis-derived insect resistance. This technology has been applied to potatoes, cotton, and corn. Benefits of Bt crops, and biotechnology generally, can be realized only if risks are assessed and managed properly. The case of Starlink corn, a plant modified with a gene that encodes the Bt protein Cry9c, was a severe test of U.S. regulatory agencies. The U.S. Environmental Protection Agency had restricted its use to animal feed due to concern about the potential for allergenicity. However, Starlink corn was later found throughout the human food supply, resulting in food recalls by the Food and Drug Administration and significant disruption of the food supply. Here we examine the regulatory history of Starlink, the assessment framework employed by the U.S. government, assumptions and information gaps, and the key elements of government efforts to manage the product. We explore the impacts on regulations, science, and society and conclude that only significant advances in our understanding of food allergies and improvements in monitoring and enforcement will avoid similar events in the future. Specifically, we need to develop a stronger fundamental basis for predicting allergic sensitization and reactions if novel proteins are to be introduced in this fashion. Mechanisms are needed to assure that worker and community aeroallergen risks are considered. Requirements are needed for the development of valid assays so that enforcement and post market surveillance activities can be conducted.

Bacillus thuringiensis↗