Upholding science in health, safety and environmental risk assessments and regulations

Michael Aschner; Herman N Autrup; Sir Colin L Berry; Alan R Boobis; Samuel M Cohen; Edmond E Creppy; Wolfgang Dekant; John Doull; Corrado L Galli; Jay I Goodman; Gio B Gori; Helmut A Greim; Philippe Joudrier; Norbert E Kaminski; Curtis D Klaassen; James E Klaunig; Marcello Lotti; Hans W J Marquardt; Olavi Pelkonen; I Glenn Sipes; Kendall B Wallace; Hiroshi Yamazaki

doi:10.1016/j.tox.2016.09.005

Upholding science in health, safety and environmental risk assessments and regulations

Toxicology. 2016 Sep 14:371:12-16. doi: 10.1016/j.tox.2016.09.005. Epub 2016 Sep 14.

Authors

Michael Aschner¹, Herman N Autrup², Sir Colin L Berry³, Alan R Boobis⁴, Samuel M Cohen⁵, Edmond E Creppy⁶, Wolfgang Dekant⁷, John Doull⁸, Corrado L Galli⁹, Jay I Goodman¹⁰, Gio B Gori¹¹, Helmut A Greim¹², Philippe Joudrier¹³, Norbert E Kaminski¹⁴, Curtis D Klaassen¹⁵, James E Klaunig¹⁶, Marcello Lotti¹⁷, Hans W J Marquardt¹⁸, Olavi Pelkonen¹⁹, I Glenn Sipes²⁰, Kendall B Wallace²¹, Hiroshi Yamazaki²²

Affiliations

¹ Professor, Molecular Pharmacology, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461, United States. Electronic address: Michael.Aschner@einstein.yu.edu.
² Emeritus Professor, Institute of Public Health, University of Aarhus, Aarhus, Denmark. Electronic address: ha@ph.au.dk.
³ Professor Emeritus of Pathology, Queen Mary, London, UK. Electronic address: colin@sircolinberry.co.uk.
⁴ Professor of Biochemical Pharmacology,Department of Medicine, Imperial College, London, UK. Electronic address: a.boobis@imperial.ac.uk.
⁵ Professor, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: scohen@unmc.edu.
⁶ Head of Toxicology Department, Faculty of Pharmaceutical Sciences, Université Bordeaux Segalen, Bordeaux, France. Electronic address: edmond.creppy@u-bordeaux.fr.
⁷ Professor of Toxicology, Department of Toxicology, University of Wuerzburg, Wuerzburg, Germany. Electronic address: dekant@toxi.uni-wuerzburg.de.
⁸ Emeritus Professor, Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: jdoull@kumc.edu.
⁹ Professor, Toxicology and Risk Assessment, Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy. Electronic address: corrado.galli@unimi.it.
¹⁰ Professor of Pharmacology and Toxicology, Michigan State University, East Lansing, USA. Electronic address: goodman3@msu.edu.
¹¹ Emeritus, The Health Policy Center, Editor, Regulatory Toxicology and Pharmacology, Bethesda, MD, USA. Electronic address: gorigb@msn.com.
¹² Emeritus Professor, Technical University of Munich, Munich, Germany. Electronic address: helmut.greim@lrz.tum.de.
¹³ Emeritus Director of Research INRA, Montpellier, France. Electronic address: philippe.joudrier@neuf.fr.
¹⁴ Professor, Pharmacology & Toxicology, Director, Institute for Integrative Toxicology, Michigan State University, East Lansing, MI, USA. Electronic address: kamins11@msu.edu.
¹⁵ Affiliate Professor, Dept. of Environmental and Occupational Health, University of Washington, Seattle, WA, USA. Electronic address: curtisklaassenphd@gmail.com.
¹⁶ Professor, Department of Environmental Health, University of Indiana, Ellettsville, IN, USA. Electronic address: jklauni@indiana.edu.
¹⁷ Professor, Department of Cardiology, Thoracic and Vascular Sciences, School of Medicine, University of Padua, Padua, Italy. Electronic address: marcello.lotti@unipd.it.
¹⁸ Professor Emeritus, Experimental and Clinical Toxicology, University of Hamburg Medical School, Hambug, Germany. Electronic address: marquardt@uke.uni-hamburg.de.
¹⁹ Professor and Chair Emeritus, Department of Pharmacology and Toxicology, Faculty of Medicine, University of Oulu, Oulu, Finland. Electronic address: olavi.pelkonen@oulu.fi.
²⁰ Professor Emeritus, University of Arizona, Tucson, AZ, USA. Electronic address: Sipes@email.arizona.edu.
²¹ Professor & Associate Dean for Faculty Affairs, University of Minnesota Medical School Duluth, Duluth, MN, USA. Electronic address: kwallace@d.umn.edu.
²² Dean of Graduate School & Professor, Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Machida, Tokyo, Japan. Electronic address: hyamazak@ac.shoyaku.ac.jp.

PMID: 27639665
DOI: 10.1016/j.tox.2016.09.005

Abstract

A public appeal has been advanced by a large group of scientists, concerned that science has been misused in attempting to quantify and regulate unmeasurable hazards and risks.¹ The appeal recalls that science is unable to evaluate hazards that cannot be measured, and that science in such cases should not be invoked to justify risk assessments in health, safety and environmental regulations. The appeal also notes that most national and international statutes delineating the discretion of regulators are ambiguous about what rules of evidence ought to apply. Those statutes should be revised to ensure that the evidence for regulatory action is grounded on the standards of the scientific method, whenever feasible. When independent scientific evidence is not possible, policies and regulations should be informed by publicly debated trade-offs between socially desirable uses and social perceptions of affordable precaution. This article explores the premises, implications and actions supporting the appeal and its objectives.

Keywords: Animal bioassays; Hazard assessment; Regulation; Regulatory ethics; Regulatory policy; Risk assessment; Scientific evidence.

MeSH terms

Animals
Disease Models, Animal
Health / legislation & jurisprudence*
Health / standards*
Humans
Legislation as Topic / standards*
Risk Assessment / legislation & jurisprudence*
Risk Assessment / standards*
Safety / legislation & jurisprudence*
Safety / standards*
Science / legislation & jurisprudence*
Science / standards*
Toxicology / legislation & jurisprudence*
Toxicology / standards*