Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

Environmental Health Sciences, Charlottesville, Virginia 22902, USA.
Environmental Health Perspectives (Impact Factor: 7.98). 04/2009; 117(3):309-15. DOI: 10.1289/ehp.0800173
Source: PubMed


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.
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.
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.
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.

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Available from: Scott M Belcher, Oct 05, 2015
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    • "Such outcomes transpire when most published studies do not meet specific criteria, even when the inclusion of this data would result in different conclusions. Although the criteria are meant to establish that the data quality is sufficient for regulation and minimizes ambiguities in cause–effect relationships, which are important for regulation and potential litigation, strict criteria can result in basing regulatory decisions on only a handful of studies (as with the assessment of bisphenol-A; Myers et al. 2009). In the 2007 and 2012 USEPA assessments on the effects of atrazine on amphibians (USEPA 2007, 2012), only one of 75 published laboratory studies (Kloas et al. 2009; field studies were evaluated but excluded from consideration) met the USEPA's criteria for quantitative assessment (i.e., useful for risk assessment; the test criteria are detailed in USEPA 2012). "
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    • "). (4) Positive controls (when feasible) limit false negative results (Myers et al., 2009), but are never mentioned in the TGs or in guidance. (5) Toxicity is almost always detected with the light microscope and a few gross biochemistry measures, rather than also employing academia's advanced imaging and biochemistry methods (Koshland Jr., 1998). "
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    • "However, decisions must be made in a timely manner to protect vulnerable populations from adverse health effects. The debate on the nature of scientific evidence on toxicity risk and regulatory response to the presence of bisphenol‐A (BPA) in consumer products mirrors the scenario presented above (Myers et al. 2009). Bisphenol‐A has long been an ingredient of numerous consumer products characterized as hard and clear plastics used as containers for both infant and adult foods and drinks. "
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