What Approaches Should be Used to Prioritize Pharmaceuticals and Personal Care Products for Research on Environmental and Human Health Exposure and Effects?

Pharmaceuticals and personal care products (PPCPs) are released from multiple anthropogenic sources and thus have a ubiquitous presence in the environment. The environmental exposure and potential effects of PPCPs on biota and humans has aroused concern within the scientific community and the public. Risk assessments are commonly conducted to evaluate the likelihood of chemicals including PPCPs that pose health threats to organisms inhabiting various environmental compartments and humans.

Comparison of false-positive rates of 2 hypothesis-test approaches in relation to laboratory toxicity test performance.

We compared 2 statistical hypothesis-test approaches (no-observed-effect concentration [NOEC] and test of significant toxicity [TST]) to determine the influence of laboratory test performance on the false-positive error rate using the US Environmental Protection Agency's Ceriodaphnia dubia reproduction whole-effluent toxicity (WET) test endpoint. Simulation and power calculations were used to determine error rates based on observed control coefficients of variation (CV) for 8 laboratories over a range of effect levels. Average C.

A framework for screening sites at risk from contaminants of emerging concern.

Trace levels of a variety of currently unregulated organic chemicals have been detected in treated wastewater effluents and surface waters that receive treated effluents. Many of these chemicals of emerging concern (CECs) originate from pharmaceuticals and personal care products that are used widely and that frequently are transported "down the drain" to a wastewater treatment plant (WWTP). Actual effects of CECs on aquatic life have been difficult to document, although biological effects consistent with effects of some CECs have been noted.

Predicted no effect concentration derivation as a significant source of variability in environmental hazard assessments of chemicals in aquatic systems: an international analysis.

Environmental hazard assessments for chemicals are carried out to define an environmentally "safe" level at which, theoretically, the chemical will not negatively affect any exposed biota. Despite this common goal, the methodologies in use are very diverse across different countries and jurisdictions. This becomes particularly obvious when international scientists work together on documents with global scope, e.

Evaluation of the test of significant toxicity for determining the toxicity of effluents and ambient water samples.

The test of significant toxicity (TST) is a hypothesis-testing approach based on bioequivalence developed by the U.S. Environmental Protection Agency (U.

Evaluation of whole effluent toxicity data characteristics and use of Welch's T-test in the test of significant toxicity analysis.

The U.S. Environmental Protection Agency (U.

It is time for changes in the analysis of whole effluent toxicity data.

The whole effluent toxicity (WET) program in the United States, Canada, and other countries typically requires multi concentration testing of effluents. While multiconcentration testing of chemicals is desirable for regulatory and scientific reasons, we believe this requirement is not as efficient for evaluating effluent compliance in a WET program. The key regulatory question of concern is whether an effluent is toxic or not, which is best answered statistically using a hypothesis approach, not a point estimate approach.

An approach for determining bioassessment performance and comparability.

Many organizations in the USA collect aquatic bioassessment data using different sampling and analysis methods, most of which have unknown performance in terms of data quality produced. Thus, the comparability of bioassessments produced by different organizations is often unknown, ultimately affecting our ability to make comprehensive assessments on large spatial scales. We evaluated a pilot approach for determining bioassessment performance using macroinvertebrate data obtained from several states in the Southeastern USA.

Test of significant toxicity: a statistical application for assessing whether an effluent or site water is truly toxic.

The U.S. Environmental Protection Agency (U.

Evaluation of effluent toxicity as an indicator of aquatic life condition in effluent-dominated streams: a pilot study.

The types and quality of data needed to determine relationships between chronic whole effluent toxicity (WET) test results and in-stream biological condition were evaluated using information collected over a 1.5-y period from 6 different sites across the United States. A data-quality-objectives approach was used that included several proposed measurement quality objectives (MQOs) that specified desired precision, bias, and sensitivity of methods used.

Toxicity models of pulsed copper exposure to Pimephales promelas and Daphnia magna.

Semiempirical models are useful for interpreting the response of aquatic organisms to toxicants as a function of exposure concentration and duration. Most applications predict cumulative mortality at the end of the test for constant exposure concentrations. Summary measures, such as the median lethal concentration, are then estimated as a function of concentration.

Effects of pulsed copper exposures on early life-stage Pimephales promelas.

Effects of pulsed copper exposures were investigated using Pimephales promelas aged less than 24 h in short-term chronic testing (7 or 14 d) with moderately hard synthetic water. Concentrations tested were between the species mean chronic value (22 microg/L at a hardness of 100 mg/L as CaCO3) and the 7-d continuous exposure EC50 for survival (40 microg/L) to examine exposures that were not acutely toxic and representative of actual wastewater discharge permit exceedences. Factors tested included pulse duration, recovery time between pulses, and pulse frequency.