title: Upholding science in health, safety and environmental risk assessments and regulations.
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.1The 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.
authors.affiliation: Professor, Molecular Pharmacology, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461, United States. Electronic address: Michael.Aschner@einstein.yu.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Aschner
authors.affiliation: Emeritus Professor, Institute of Public Health, University of Aarhus, Aarhus, Denmark. Electronic address: ha@ph.au.dk.
authors.forename: Herman N
authors.initials: HN
authors.lastname: Autrup
authors.affiliation: Professor Emeritus of Pathology, Queen Mary, London, UK. Electronic address: colin@sircolinberry.co.uk.
authors.forename: Sir Colin L
authors.initials: SC
authors.lastname: Berry
authors.affiliation: Professor of Biochemical Pharmacology,Department of Medicine, Imperial College, London, UK. Electronic address: a.boobis@imperial.ac.uk.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Boobis
authors.affiliation: Professor, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: scohen@unmc.edu.
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Cohen
authors.affiliation: Head of Toxicology Department, Faculty of Pharmaceutical Sciences, Université Bordeaux Segalen, Bordeaux, France. Electronic address: edmond.creppy@u-bordeaux.fr.
authors.forename: Edmond E
authors.initials: EE
authors.lastname: Creppy
authors.affiliation: Professor of Toxicology, Department of Toxicology, University of Wuerzburg, Wuerzburg, Germany. Electronic address: dekant@toxi.uni-wuerzburg.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Dekant
authors.affiliation: Emeritus Professor, Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: jdoull@kumc.edu.
authors.forename: John
authors.initials: J
authors.lastname: Doull
authors.affiliation: Professor, Toxicology and Risk Assessment, Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy. Electronic address: corrado.galli@unimi.it.
authors.forename: Corrado L
authors.initials: CL
authors.lastname: Galli
authors.affiliation: Professor of Pharmacology and Toxicology, Michigan State University, East Lansing, USA. Electronic address: goodman3@msu.edu.
authors.forename: Jay I
authors.initials: JI
authors.lastname: Goodman
authors.affiliation: Emeritus, The Health Policy Center, Editor, Regulatory Toxicology and Pharmacology, Bethesda, MD, USA. Electronic address: gorigb@msn.com.
authors.forename: Gio B
authors.initials: GB
authors.lastname: Gori
authors.affiliation: Emeritus Professor, Technical University of Munich, Munich, Germany. Electronic address: helmut.greim@lrz.tum.de.
authors.forename: Helmut A
authors.initials: HA
authors.lastname: Greim
authors.affiliation: Emeritus Director of Research INRA, Montpellier, France. Electronic address: philippe.joudrier@neuf.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Joudrier
authors.affiliation: Professor, Pharmacology & Toxicology, Director, Institute for Integrative Toxicology, Michigan State University, East Lansing, MI, USA. Electronic address: kamins11@msu.edu.
authors.forename: Norbert E
authors.initials: NE
authors.lastname: Kaminski
authors.affiliation: Affiliate Professor, Dept. of Environmental and Occupational Health, University of Washington, Seattle, WA, USA. Electronic address: curtisklaassenphd@gmail.com.
authors.forename: Curtis D
authors.initials: CD
authors.lastname: Klaassen
authors.affiliation: Professor, Department of Environmental Health, University of Indiana, Ellettsville, IN, USA. Electronic address: jklauni@indiana.edu.
authors.forename: James E
authors.initials: JE
authors.lastname: Klaunig
authors.affiliation: Professor, Department of Cardiology, Thoracic and Vascular Sciences, School of Medicine, University of Padua, Padua, Italy. Electronic address: marcello.lotti@unipd.it.
authors.forename: Marcello
authors.initials: M
authors.lastname: Lotti
authors.affiliation: Professor Emeritus, Experimental and Clinical Toxicology, University of Hamburg Medical School, Hambug, Germany. Electronic address: marquardt@uke.uni-hamburg.de.
authors.forename: Hans W J
authors.initials: HW
authors.lastname: Marquardt
authors.affiliation: Professor and Chair Emeritus, Department of Pharmacology and Toxicology, Faculty of Medicine, University of Oulu, Oulu, Finland. Electronic address: olavi.pelkonen@oulu.fi.
authors.forename: Olavi
authors.initials: O
authors.lastname: Pelkonen
authors.affiliation: Professor Emeritus, University of Arizona, Tucson, AZ, USA. Electronic address: Sipes@email.arizona.edu.
authors.forename: I Glenn
authors.initials: IG
authors.lastname: Sipes
authors.affiliation: Professor & Associate Dean for Faculty Affairs, University of Minnesota Medical School Duluth, Duluth, MN, USA. Electronic address: kwallace@d.umn.edu.
authors.forename: Kendall B
authors.initials: KB
authors.lastname: Wallace
authors.affiliation: Dean of Graduate School & Professor, Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Machida, Tokyo, Japan. Electronic address: hyamazak@ac.shoyaku.ac.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamazaki
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D006262:Health / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D007878:Legislation as Topic / Q000592:standards*; D018570:Risk Assessment / Q000331:legislation & jurisprudence* / Q000592:standards*; D012449:Safety / Q000331:legislation & jurisprudence* / Q000592:standards*; D012586:Science / Q000331:legislation & jurisprudence* / Q000592:standards*; D014116:Toxicology / Q000331:legislation & jurisprudence* / Q000592:standards*
keywords: Animal bioassays; Hazard assessment; Regulation; Regulatory ethics; Regulatory policy; Risk assessment; Scientific evidence