title: Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A.
abstract: BACKGROUND
  In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world.
  
  
  OBJECTIVE
  We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes.
  
  
  CONCLUSIONS
  Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., "good science"). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research.
  
  
  CONCLUSIONS
  Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals.
authors.affiliation: Environmental Health Sciences, Charlottesville, Virginia 22902, USA. jpmyers@ehsic.org
authors.forename: John Peterson
authors.initials: JP
authors.lastname: Myers
authors.forename: Frederick S
authors.initials: FS
authors.lastname: vom Saal
authors.forename: Benson T
authors.initials: BT
authors.lastname: Akingbemi
authors.forename: Koji
authors.initials: K
authors.lastname: Arizono
authors.forename: Scott
authors.initials: S
authors.lastname: Belcher
authors.forename: Theo
authors.initials: T
authors.lastname: Colborn
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Chahoud
authors.forename: D Andrew
authors.initials: DA
authors.lastname: Crain
authors.forename: Francesca
authors.initials: F
authors.lastname: Farabollini
authors.forename: Louis J
authors.initials: LJ
authors.lastname: Guillette
authors.forename: Terry
authors.initials: T
authors.lastname: Hassold
authors.forename: Shuk-mei
authors.initials: SM
authors.lastname: Ho
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Hunt
authors.forename: Taisen
authors.initials: T
authors.lastname: Iguchi
authors.forename: Susan
authors.initials: S
authors.lastname: Jobling
authors.forename: Jun
authors.initials: J
authors.lastname: Kanno
authors.forename: Hans
authors.initials: H
authors.lastname: Laufer
authors.forename: Michele
authors.initials: M
authors.lastname: Marcus
authors.forename: John A
authors.initials: JA
authors.lastname: McLachlan
authors.forename: Angel
authors.initials: A
authors.lastname: Nadal
authors.forename: Jörg
authors.initials: J
authors.lastname: Oehlmann
authors.forename: Nicolás
authors.initials: N
authors.lastname: Olea
authors.forename: Paola
authors.initials: P
authors.lastname: Palanza
authors.forename: Stefano
authors.initials: S
authors.lastname: Parmigiani
authors.forename: Beverly S
authors.initials: BS
authors.lastname: Rubin
authors.forename: Gilbert
authors.initials: G
authors.lastname: Schoenfelder
authors.forename: Carlos
authors.initials: C
authors.lastname: Sonnenschein
authors.forename: Ana M
authors.initials: AM
authors.lastname: Soto
authors.forename: Chris E
authors.initials: CE
authors.lastname: Talsness
authors.forename: Julia A
authors.initials: JA
authors.lastname: Taylor
authors.forename: Laura N
authors.initials: LN
authors.lastname: Vandenberg
authors.forename: John G
authors.initials: JG
authors.lastname: Vandenbergh
authors.forename: Sarah
authors.initials: S
authors.lastname: Vogel
authors.forename: Cheryl S
authors.initials: CS
authors.lastname: Watson
authors.forename: Wade V
authors.initials: WV
authors.lastname: Welshons
authors.forename: R Thomas
authors.initials: RT
authors.lastname: Zoeller