Environmental Effects Testing Research Articles

Chronic effects of 17α-ethinylestradiol, fluoxetine, and the mixture on individual and population-level end points in Daphnia magna.

Many pharmaceuticals and personal care products (PPCPs) enter the environment continuously. Because these chemicals are not intended for environmental applications, testing for environmental effects is not mandatory, and thus relatively little is known about their ecological effects, particularly on invertebrate species. To better understand the effects of PPCPs on freshwater invertebrates, we exposed the water flea Daphnia magna to environmentally relevant concentrations of the pharmaceuticals 17α-ethinylestradiol (EE2) and fluoxetine both individually and as a mixture for 40 days. Exposure to EE2 decreased the number of neonates produced per female at 0.1 and 1.0 µg/L EE2, whereas fluoxetine increased mortality and neonate production at 100 µg/L. Exposure to the mixture of EE2 + fluoxetine increased time to first reproduction in medium and high mixture treatments and decreased time to death and neonate production in the high mixture treatment. When these individual parameters were integrated into a demographic model, population growth rate decreased when D. magna were exposed to 0.1 and 1.0 µg/L EE2, 100 µg/L fluoxetine, and low and high mixture treatments. When we compared the results of our extended 40 day exposures with data from only the first 21 days, the standard duration of chronic toxicity tests with D. magna, the effects of pharmaceutical exposure were generally significant at lower chemical concentrations during the 21-day period compared with the 40-day exposures, which points to the importance of exposure duration in drawing inferences from toxicity studies.

Impact of lightning and high-intensity radiated fields on cables in aircraft

This article shows how electromagnetic simulation tools can be used early in the design stage to predict the impacts of lightning and high-intensity radiated fields on cable harnesses in aircraft. Furthermore, it shows how with such tools appropriate cable shielding can be devised that ensures the aircraft will pass the Electromagnetic Environmental Effects testing without adding unnecessary weight.

Electromagnetic Environmental Effects Testing of Medical Devices Including Those Used for the Treatment of Diabetes

Electromagnetic emissions from technologies that surround us can produce interference with implanted and externally worn medical devices. Electromagnetic environmental effects (E3) testing of medical devices at the Georgia Tech Research Institute (GTRI) began almost four decades ago and continues to incorporate new devices and new sources of electromagnetic emissions as they are developed and become available. The GTRI Medical Device Test Center provides real-world exposure fields to identify interactions and help manufacturers prevent disruptions from the environments in which their devices must function. Typically, the medical device is mounted in or on a torso simulator containing a saline solution that simulates the electrical characteristics of the body. The torso simulator and the device under test are then moved through the fields generated by production security and logistical system technologies using a computer-controlled positioning system. These tests are conducted with different orientations of the medical device to the electromagnetic source, simulating the way in which device wearers interact with these systems in representative situations. Particular E3 test results measured on specific devices in the GTRI Medical Device Test Center are proprietary; however, the results of tests to date with current medical devices used for the treatment of diabetes have been encouraging. These devices have included implantable and externally worn insulin infusion pumps and continuous glucose monitoring systems from different manufacturers. Since E3 tests of diabetes treatment devices to date in the test center have centered on devices from only a few of the many current manufacturers, further testing is warranted. In addition, increased functionality, which is being added to existing devices, will create new possibilities for interference in the future.

Recent advances in solar sail propulsion systems at NASA

Supporting NASA's Science Mission Directorate, the In-Space Propulsion Technology (ISPT) Program is developing solar sail propulsion (SSP) for use in robotic science and exploration of the solar system. SSP will provide longer on-station operation, increased scientific payload mass fraction, and access to previously inaccessible orbits for multiple potential science missions. Two different 20-m solar sail systems were produced and successfully completed functional vacuum testing last year in NASA Glenn's Space Power Facility at Plum Brook Station, Ohio. The sails were designed and developed by ATK Space Systems and L’Garde, respectively. These sail systems consist of a central structure with four deployable booms that support the sails. These sail designs are robust enough for deployments in a one atmosphere, one gravity environment, and are scalable to much larger solar sails—perhaps as much as 150 m on a side. In addition, computation modeling and analytical simulations have been performed to assess the scalability of the technology to the large sizes ( > 150 m) required for first generation solar sail missions. Life and space environmental effects testing of sail and component materials are also nearly complete. This paper will summarize recent technology advancements in solar sails and their successful ambient and vacuum testing.

The environmental risk assessment of human pharmaceuticals in the overall EU regulatory affairs process

The approval of new human pharmaceutical products in the EU requires an assessment of potential environmental risks related to the use by patients, besides the evaluation of the human safety, efficacy, and quality evaluation. The current guidance by the European Medicines Agency (EMEA), describing the process of the environmental risk assessment for human drugs, covers a two-tiered assessment programme with a modelling step for an environmental exposure scenario and a subsequent step of environmental fate and effects testing. The following paper describes ways how the requirements of the environmental risk assessment can be sensibly incorporated in the overall approval process of a pharmaceutical product including the risk/benefit analysis for the patient. The resources for environmental testing and assessment programmes can be employed economically, if the pharmacological, toxicological, and pharmacokinetic information obtained during the development programme of a human pharmaceutical is used to develop substance-specific test programmes and to evaluate the environmental risk assessment taking into account the pharmacodynamic properties and the use pattern by patients. Finally, we suggest that the environmental risk evaluation process as part of drug approvals should adhere to a focussed assessment strategy considering existing knowledge and the therapeutic needs.

Human pharmaceuticals in the aquatic environment a review.

There has been increasing concern in recent years about the occurrence, fate and toxicity of pharmaceutical products in the aquatic environment. Many of the more commonly used drug groups (for example antibiotics) are used in quantities similar to those of pesticides and other organic micropollutants, but they are not required to undergo the same level of testing for possible environmental effects. The full extent and consequences of the presence of these compounds in the environment are therefore largely unknown and the issue as a whole is ill-defined. Although these compounds have been detected in a wide variety of environmental samples including sewage effluent, surface waters, groundwater and drinking water, their concentrations generally range from the low ppt to ppb levels. It is therefore often thought to be unlikely that pharmaceuticals will have a detrimental effect on the environment. However, the lack of validated analytical methods, limited monitoring data and the lack of information about the fate and toxicity of these compounds and/or their metabolites in the aquatic environment makes accurate risk assessments difficult.

Human Pharmaceuticals in the Aquatic Environment a Review

There has been increasing concern in recent years about the occurrence, fate and toxicity of pharmaceutical products in the aquatic environment. Many of the more commonly used drug groups (for example antibiotics) are used in quantities similar to those of pesticides and other organic micropollutants, but they are not required to undergo the same level of testing for possible environmental effects. The full extent and consequences of the presence of these compounds in the environment are therefore largely unknown and the issue as a whole is ill-defined. Although these compounds have been detected in a wide variety of environmental samples including sewage effluent, surface waters, groundwater and drinking water, their concentrations generally range from the low ppt to ppb levels. It is therefore often thought to be unlikely that pharmaceuticals will have a detrimental effect on the environment. However, the lack of validated analytical methods, limited monitoring data and the lack of information about the fate and toxicity of these compounds and/or their metabolites in the aquatic environment makes accurate risk assessments very difficult.

Effect of two commercial formulations of Bacillusthuringiensis suhsp. kurstaki on the forest earthworm Dendrobaenaoctaedra

The effects of Dipel®8L and Dipel®8AF (two formulations of Bacillusthuringiensis subsp. kurstaki (B.t.k.)) on the survival, growth, and reproduction of the forest earthworm Dendrobaenaoctaedra (Sav.) were studied in the laboratory using simple soil–litter microcosms. Dendrobaenaoctaedra was not adversely affected by an unformulated preparation of B.t.k. or by the aqueous formulation (Dipel®8AF) even at doses representing 1000× the expected environmental concentration (EEC). However, survival, growth, and cocoon production were significantly reduced in the presence of Dipel®8L at 1000× EEC, which is the level recommended for Tier I testing for environmental effects according to the Canadian guidelines for registration of naturally occurring microbial pest control agents. Further tests indicated that the toxic component of the Dipel®8L was the oil-based formulation blank. No significant deleterious effects on survival, growth, or reproduction were observed in microcosms sprayed with Dipel®8L at the EEC, 10× EEC, or 100× EEC. There was no evidence of a synergistic reaction between oil-based formulation ingredients and B.t.k., which would act to increase the susceptibility of D. octaedra to the bacterium.

Existing chemical testing for environmental fate and effects under TSCA section 4: A case study with octamethylcyclotetrasiloxane (OMCTS)

AbstractOctamethylcyclotetrasiloxane (OMCTS, or D4) is a highly volatile, cyclic silicone that is an important intermediate in the synthesis of polydimethylsiloxanes and other higher‐molecular‐weight silicones. As a category of chemicals, silicones have generated substantial scientific and regulatory interest over the last few years. OMCTS, one of the first silicones considered for regulatory review, was recommended for testing in the 15th Report of the Interagency Testing Committee (ITC) in 1984 based on its high volume of production, alleged presence in aquatic environments, and the general lack of environmental fate and effects information for this type of compound. As a result, the environmental effects and fate of OMCTS have been extensively evaluated in a series of laboratory toxicity and environmental fate studies, fate modeling studies, and field monitoring studies. Most of these studies were conducted as part of a negotiated consent order (CO) under Section 4 of the Toxic Substances Control Act (TSCA). Applying the principles of ecological risk assessment (ERA) to the OMCTS program, the current paper presents the problem‐formulation phase of the ERA process including stressor characteristics, identification of the ecosystem potentially at risk, and development of a conceptual model. In addition, the planning phase with interactions among the industry representatives, the risk assessors, and the risk managers are discussed. OMCTS was one of the first chemicals to reach the RM1 (risk management) level of regulatory analysis under TSCA, which resulted in a determination that no additional data was needed. Application of ERA principles in this program were instrumental in this favorable determination.

Selection of field and laboratory studies for environmental assessment

Selection and conduct of the proper field and/or laboratory studies for inclusion in an Environmental Assessment of EPA and FDA regulated chemicals are often poorly understood or appreciated. This may lead to performance of inappropriate, invalid, or insufficient studies resulting in increased regulatory review time or rejection of submissions. The focus of this presentation is on studies listed in FDA and EPA guidelines. A rationale for environmental fate and effects testing is presented together with a tabulated summary of suggested tests by FDA and EPA for regulated chemicals. A description of studies, their significance, and a logical, efficient approach to selecting appropriate studies is also presented.

Modelling the Increase in Variance of Fish Weight

A simple model is described that is very effective in accounting for the variance in fish weights in groups of fish grown under controlled environmental conditions. The model explains the increase in variation over time in terms of final weight and the time required to reach this weight and is independent of initial weight and feeding rate. Results from experiments with rainbow trout (Oncorhynchus mykiss) and Arctic char (Salvelinus alpinus) were used to confirm the model's fit and to demonstrate how temperature effects can be incorporated. We discuss the use of the model for prediction and for testing for genetic or environmental effects on variation and for quantifying such effects on variance over time.

Chemical fate, bioconcentration, and environmental effects testing: Proposed testing and decision criteria

AbstractChemicals should have a minimum amount of available chemical fate, bioconcentration, and environmental effects data to identify those chemicals with potentially problematic environmental partitioning or persistence, or those with potential to bioconcentrate or cause adverse effects. Professional judgment, estimates of a chemical's mode(s) of action or mechanism of action, and its susceptibility to rapid transport or transformation should be utilized to determine the types of chemical fate, bioconcentration, and environmental effects data that should be available. Data‐supported decision criteria should be used to develop additional data to characterize the persistence, bioconcentration, and adverse effects of chemicals that have been identified as potentially problematic. To facilitate an understanding of minimum chemical fate and bioconcentration data that should be available, recommended chemical fate and bioconcentration data from previously published testing schemes or approaches were evaluated. For environmental effects data, the types of organisms recommended for developing aquatic toxicity data in previously published testing schemes or approaches were evaluated. To facilitate an understanding of available testing decision criteria, those criteria that were used (as of December 31, 1988) to propose or require chemical fate, bioconcentration, on aquatic toxicity tests under section 4 of the Toxic Substances Control Act and those criteria recommended in previously reported testing schemes were evaluated. Based on this comprehensive evaluation it was possible to propose (1) a base set of chemical fate and aquatic toxicity tests, (2) organisms for conducting aquatic toxicity tests, and (3) decision logic and testing scheme for developing chemical fate and aquatic toxicity test data.

Bioconcentration, chemical fate, and environmental effects testing under section 4 of the Toxic Substances Control Act

AbstractAs of December 31, 1988, the U.S. Environmental Protection Agency (EPA) had published 49 Federal Register (FR) notices acknowledging, proposing, or requiring development of bioconcentration, chemical fate, or environmental effects testing data under Section 4 of the Toxic Substances Control Act (TSCA). These FR notices included 5 Decisions Not to Test (DNTs) that acknowledged industry testing, 19 Notices of Proposed Rulemaking (NPRs) that proposed testing by industry, 9 Notices of Final Rulemaking (NFRs), and 2 Consent Orders (COs) that required industry testing as well as 7 proposed and 7 final Negotiated Testing Agreements (NTAs). Two bioconcentration, 12 chemical fate, and 28 environmental effects tests were submitted to the EPA by industry as a result of issuing DNTs. Industry completed 3 bioconcentration, 86 chemical fate, and 151 environmental effects tests after publication of NTAs. Two bioconcentration, 11 chemical fate, and 14 environmental effects tests were completed as a result of publishing NFRs; 1 chemical fate and 5 environmental effects tests were completed under a CO. As of December 31, 1988, a total of 7 bioconcentration, 110 chemical fate, and 234 environmental effects tests had been completed under TSCA Section 4.

Environmental effects testing with quantitative microbial analysis: Chemical signatures correlated with in situ biofilm analysis by FT/IR

AbstractChemical measures for the biomass, community structure, nutritional status, and metabolic activities of the microbiota have shown a remarkable responsiveness to changes in the bulk fluid physical and chemical properties, the chemistry, biodegradability, and microtopology of the surfaces, as well as biological factors such as predation. Chemical analysis of the microbiota (bacteria, algae, fungi, protozoa, and micrometazoa with their extracellular products <0.5mm in diameter) does not require quantitative release of the organisms from surfaces or that the organisms are able to form colonies in subcultures. The sensitivity of the microbiota to changes in their habitat suggests that these chemical measures could provide a quantitative method for environmental effects testing. Changes in the marine benthic microbiota exposure to xenobiotics at the ug/l level or oil and gas well‐drilling fluids demonstrate this sensitivity. These analyses do not destroy the vital interactions within microcolonies of mixed physiological types that characterize many environments. The chemical measures are destructive. Non‐destructive analysis of biofilms of areas in the size range of microcolonies by Fourier transforming infrared spectrometry may ultimately provide the most effective method for environmental effects testing.

Impact of Restrictions on Toxic Substances on the Production of Synthetic Materials

Abstract The Toxic Substances Control Act (TSCA) has started to have a significant impact on the chemical industry. This act gives the Environmental Protection Agency (EPA) far-reaching authority to regulate the manufacture, processing, use, and disposal of chemicals perceived to be dangerous to the health of mankind and/or to the environment. According to the current list of chemical substances for testing for health and environmental effects [15], benzene-based chemicals are exposed to intense scrutiny and decisions made regarding such chemicals would have serious effects on growth and development of certain sectors of the chemical industry.