Using environmental concentration exposure datasets in environmental assessments: The development of Criteria for Reporting and Evaluating Exposure Datasets (CREED)

Key Points

- Frameworks for the evaluation reliability (quality) and relevance (fitness for purpose) of exposure data are not as well developed as frameworks for evaluating reliability and relevance.

- Not all exposure data are fit for all purposes, including secondary applications beyond the original intent.

- CREED provide a consistent, transparent, and practical approach for ensuring exposure data quality and fitness for purpose.

- CREED serve as guidance for data users, data generators, and database owners.

Key Points

- As part of “Criteria for Reporting and Evaluating Exposure Datasets,” we present specific criteria to systematically evaluate the reliability (data quality) of environmental exposure datasets for use in risk assessment.

- Criteria for Reporting and Evaluating Exposure Datasets is a systematic, transparent procedure that can help risk assessors understand and characterize uncertainties in existing datasets and serves as guidance on best practice for the reporting of data for data generators to maximize utility of their datasets.

- Reliability criteria address the identification of analytes, study sites, environmental matrices, sampling dates, sample collection methods, analytical method performance, data handling, treatment of censored data, and generation of summary statistics.

- Criteria for Reporting and Evaluating Exposure Datasets reliability evaluation includes the identification of data limitations that may affect data usability, and when paired with relevance evaluation (assessed separately), can be used to determine the extent to which environmental monitoring datasets are “fit for purpose.”

Key Points

- This article provides an overview and guidance on the relevance assessment in the context of the Criteria for the Reporting and Evaluation of Exposure Data approach for evaluating exposure monitoring data sets.

- Relevance is defined here as the degree of suitability or appropriateness of a data set to address a specific purpose that has been defined by the assessor, or for those generating exposure data.

- A clear purpose definition is the foundation for the relevance assessment, to clarify how the assessor should rate the assessment criteria (fully met, partly met, not met/inappropriate, not reported, not applicable).

- This approach provides transparency for anyone reviewing the outcomes, and an explicit gap analysis (i.e., an articulation of the data set limitations for the stated purpose) is an important outcome of the relevance assessment.

Key Points

- We present a synthesis of the “Criteria for Reporting and Evaluating Exposure Datasets” (CREED) approach for evaluating the reliability and relevance of exposure data for use in environmental assessment.

- We present methods for summarizing and interpreting the outcomes of the data usability evaluation in support of decision-making and communication.

- We developed a scoring system and report card to communicate the outcome of the CREED data usability evaluation and summarize important dataset attributes and limitations.

- We describe key findings of a beta test that tested the utility of the CREED approach and present three case studies that illustrate its application.