Academic journal article Environmental Health Perspectives

Key Elements for Judging the Quality of a Risk Assessment

Academic journal article Environmental Health Perspectives

Key Elements for Judging the Quality of a Risk Assessment

Article excerpt

Introduction

A number of U.S. federal (as well as state and local) government agencies produce risk assessments on a continuing basis. In the years since the publication of the 1983 National Research Council (NRC) report, Risk Assessment in the Federal Government: Managing the Process (the "Red Book," NRC 1983), advances in risk assessment have occurred, but the need for further improvement continues to be recognized. Much attention has been focused on the risk assessment practices of the U.S. Environmental Protection Agency (U.S. EPA), although recommendations for improvement have also been directed toward other agencies. In our opinion, the problems ascribed by critics to these assessments generally do not lie in the lack of guidance on how to conduct an assessment but rather in the failure to implement internal guidance or externally generated recommendations in a consistent and transparent manner. The aim of this work was to extract from the accumulated recommendations of many expert panels a set of attributes that can serve as a guide for judging whether an assessment has incorporated consensus best practices that result in a scientifically credible, transparent, and useful product. By "best practices," we mean that an assessment possesses scientific accountability and integrity by employing a critical, open-minded approach in selecting reliable data and models fit for their intended use and in analyzing and integrating that information. The assessment should use defined methodologies for collecting and interpreting information and for minimizing any bias that might be introduced. Its development process embraces the necessary scoping and planning before the assessment is conducted. Here, best practices ensure that transparency exists throughout to enable others to judge the scientific robustness of the conclusions and to replicate the findings and that the uncertainties associated with the assessment are described. Finally, the assessment should be readily usable and provide value to its intended audiences.

The guide presented in Appendix 1 has been designed for use by decision makers to assist in their quest to have a high-quality assessment at hand when carrying out their responsibilities and for use by authors, sponsors, risk assessors, peer reviewers, and other interested stakeholders to determine if an assessment meets the current best scientific practices. The use of the guide is intended to promote transparency and consistency with regard to the conduct and quality of assessments.

Methods

A general consensus has been evolving over the past several years regarding the characteristics that high-quality assessments should possess. A review of a series of primarily government-funded expert panel reports was conducted to identify, assemble, and synthesize the key elements of a high-quality assessment for the purpose of creating a simple and useful quality assurance guide. These reports included those of the NRC, the Institute of Medicine (IOM), the Presidential/Congressional Commission on Risk Assessment and Risk Management, and a number of foreign governments and organizations [e.g., European Chemicals Agency (ECHA) 2011; European Food Safety Agency (EFSA) 2010, 2011, 2014a, 2014b; Health Canada 2000, 2015; IOM 2011; NRC 1983, 1994, 1996, 2007, 2009, 2011, 2013, 2014; Organisation of Economic Co-operation and Development (OECD) 2007, 2012].

Reports Relevant to the Development of the Guide for Judging the Quality of an Assessment

The processes by which risk assessments are developed as well as their substance and content have been the subject of deliberation by many parties over the last > 30 years. The U.S. Congress, the Executive Branch, various commissions, NRC and IOM committees, affected stakeholder communities, and even the general public and individuals have all weighed in. Over time, there has been a shift in, and an expansion of, the areas of focus on the elements of the risk-assessment process. …

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