title: NIEHS/FDA CLARITY-BPA research program update.
abstract: Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program.
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of Extramural Research and Training, Research Triangle Park, NC 27709, United States. Electronic address: heindelj@niehs.nih.gov.
authors.forename: Jerrold J
authors.initials: JJ
authors.lastname: Heindel
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of the National Toxicology Program, Research Triangle Park, NC 27709, United States.
authors.forename: Retha R
authors.initials: RR
authors.lastname: Newbold
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of the National Toxicology Program, Research Triangle Park, NC 27709, United States.
authors.forename: John R
authors.initials: JR
authors.lastname: Bucher
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Luísa
authors.initials: L
authors.lastname: Camacho
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: K Barry
authors.initials: KB
authors.lastname: Delclos
authors.affiliation: Office of Scientific Coordination, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Sherry M
authors.initials: SM
authors.lastname: Lewis
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Michelle
authors.initials: M
authors.lastname: Vanlandingham
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Mona I
authors.initials: MI
authors.lastname: Churchwell
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Nathan C
authors.initials: NC
authors.lastname: Twaddle
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Michelle
authors.initials: M
authors.lastname: McLellen
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Mani
authors.initials: M
authors.lastname: Chidambaram
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bryant
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Kellie
authors.initials: K
authors.lastname: Woodling
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Gonçalo
authors.initials: G
authors.lastname: Gamboa da Costa
authors.affiliation: Division of Neurotoxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Sherry A
authors.initials: SA
authors.lastname: Ferguson
authors.affiliation: Department of Comparative Biosciences, University of Illinois, Urbana, IL 61802, United States.
authors.forename: Jodi
authors.initials: J
authors.lastname: Flaws
authors.affiliation: Office of Scientific Coordination, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, United States.
authors.forename: Paul C
authors.initials: PC
authors.lastname: Howard
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of the National Toxicology Program, Research Triangle Park, NC 27709, United States.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Walker
authors.affiliation: Biology Department, University of Massachusetts, Amherst, MA 01003, United States.
authors.forename: R Thomas
authors.initials: RT
authors.lastname: Zoeller
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of the National Toxicology Program, Research Triangle Park, NC 27709, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Fostel
authors.affiliation: Team Vistronix, NTP Computer and User Support, National Institute of Environmental Health Sciences/National Institutes of Health, Division of the National Toxicology Program, Research Triangle Park, NC 27709, United States.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Favaro
authors.affiliation: National Institute of Environmental Health Sciences/National Institutes of Health, Division of Extramural Research and Training, Research Triangle Park, NC 27709, United States.
authors.forename: Thaddeus T
authors.initials: TT
authors.lastname: Schug
mesh_terms: D000818:Animals; D001559:Benzhydryl Compounds / Q000009:adverse effects*; D035843:Biomedical Research / Q000379:methods* / Q000458:organization & administration; D003299:Cooperative Behavior; D004305:Dose-Response Relationship, Drug; D004781:Environmental Exposure / Q000009:adverse effects; D004785:Environmental Pollutants / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007373:Interinstitutional Relations; D008297:Male; D023421:Models, Animal; D010636:Phenols / Q000009:adverse effects*; D016730:Program Development; D015397:Program Evaluation; D018570:Risk Assessment; D014116:Toxicology / Q000379:methods* / Q000458:organization & administration; D000098826:Bisphenol A Compounds
chemical_list: D001559:Benzhydryl Compounds; D004785:Environmental Pollutants; D010636:Phenols; C006780:bisphenol A; D000098826:Bisphenol A Compounds
keywords: Bisphenol A; CLARITY-BPA; Consortium; Endocrine disruptors; FDA; NIEHS; NTP