Background: The most essential goal of medicine and public health is to prevent harm ( primum non nocere ). This goal is only fully achieved with primary prevention, which requires us to identify and prevent harms prior to human exposure through research and testing that does not involve human subjects. For that reason, public health policies place considerable reliance on nonhuman toxicological studies. However, toxicology as a field has often not produced efficient and timely evidence for decision making in public health. In response to this, the U.S. National Research Council called for the adoption of evidence-based methods and systematic reviews in regulatory decision making. The U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the European Food Safety Agency (EFSA) have recently endorsed these methods in their assessments of safety and risk.

Objectives: In this commentary we summarize challenges and problems in current practices in toxicology as applied to decision making. We compare these practices with the principles and methods utilized in evidence-based medicine and health care, with emphasis on the record of the Cochrane Collaboration.

Discussion: We propose a stepwise strategy to support the development, validation, and application of evidence-based toxicology (EBT). We discuss current progresses in this field produced by the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program and the Navigation Guide works. We propose that adherence to the Cochrane principles is a fundamental prerequisite for the development and implementation of EBT.

Conclusion: The adoption of evidence-based principles and methods will enhance the validity, transparency, efficiency, and acceptance of toxicological evidence, with benefits in terms of reducing delays and costs for all stakeholders (researchers, consumers, regulators, and industry).

Citation: Mandrioli D, Silbergeld EK. 2016. Evidence from toxicology: the most essential science for prevention. Environ Health Perspect 124:6–11; http://dx.doi.org/10.1289/ehp.1509880

Address correspondence to D. Mandrioli, Cesare Maltoni Cancer Research Center, Ramazzini Institute, Via Saliceto 3, Bentivoglio, Bologna, 40010, Italy. Telephone: 39 051 6640460. E-mail: mandriolid@ramazzini.it

We thank continuing conversations with principals in the Cochrane Collaboration, especially K. Dickersin and R. Scherer of the U.S. Cochrane Center; L. Bero, E. Waters, M. Ritskes-Hoitinga, and other members of the working group on animal testing and other attendees at a working group held during the 23rd Cochrane Colloquium. We also thank L. Rosman and A. Navas Acien (Johns Hopkins), F. Belpoggi (Cesare Maltoni Cancer Research Center, Ramazzini Institute), and our colleagues in the work of developing methods for evidence-based toxicology: T. Woodruff (University of California, San Francisco), K. Thayer (National Institute of Environmental Health Sciences), and V. Cogliano (U.S. Environmental Protection Agency.

The authors received no funds to support the writing or production of this paper.

The authors declare they have no actual or potential competing financial interests.

Received: 25 February 2015 Accepted: 12 June 2015 Advance Publication: 19 June 2015 Final Publication: 1 January 2016

Note to readers with disabilities: EHP strives to ensure that all journal content is accessible to all readers. However, some figures and Supplemental Material published in EHP articles may not conform to 508 standards due to the complexity of the information being presented. If you need assistance accessing journal content, please contact ehp508@niehs.nih.gov . Our staff will work with you to assess and meet your accessibility needs within 3 working days.