It's time to ‘dare to start again’ with bisphenol A (BPA) risk assessment as industry-sponsored research and peer-reviewed studies seem to "deviate strongly", according to the European Environment Agency (EEA).
“Numerous papers from different laboratories indicate risks at low doses, BPA industry-sponsored studies need doses orders of magnitude higher to produce any effects and if effects are detected they are not taken forward to the risk assessment,” write Andreas Gies and Ana Soto in a subsection of their paper, Bisphenol A: contested science, divergent safety evaluations.
The paper, published in the 2013 Late lessons from early warnings report produced by the EEA, is based on the scientific opinions of Gies, head of the Department of Environmental Hygiene at the Federal Environment Agency, Berlin and Soto, professor of Anatomy and Cellular Biology at Tufts University, USA.
The authors also raised questions over the studies relied upon at the time by the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) to form their assessments.
FDA and EFSA relied on a handful of Good Laboratory Practice (GLP) multi-generational studies done in contract laboratories that assessed only reproduction, body and organ weights, clinical chemistry and organ histopathology using hematoxylin and eosin (H&E) staining, they wrote.
“The same endpoints had been used for the past 50 years: before endocrine disruptors were known, before the developmental basis of disease and gene expression and epigenetics were known, and before low-dose and non‑monotonic dose responses were known.
“It is remarkable that the FDA and EFSA used guideline studies to indicate that BPA is safe while ignoring over 800 peer-reviewed studies that showed toxicity of BPA at exposure levels below the level of human exposure.
“Certainly there are data gaps, but the practice of regulatory agencies of disregarding, or worse, declaring unfit every peer-reviewed study that does not follow the guideline study design cannot be defensible.”
An EFSA spokesperson told FoodProductionDaily.com that experts considered hundreds of scientific publications in peer-reviewed scientific journals as well as reports from studies submitted by industry.
The body is in the process of delivering a risk assessment on BPA, which is primarily used to make polycarbonate plastics, due for May this year.
The spokesperson added that the quality criteria includes sufficient size sample, adequacy of control procedures, inclusion of positive controls when applicable; appropriate statistical methods and controls for environmental contamination.
"The inclusion criteria include full research papers published in peer-reviewed journals available in the public domain since the EFSA 2010 opinion (July 2010-December 2012); previous governmental risk assessments and reports using original data, human studies, animal toxicity studies and in vitro studies."
“Until final decisions are made, precautionary measures should be taken to lower human exposures to well below those that cause adverse effects in rodents and behavioural changes in humans in epidemiological studies,” said Gies and Soto.
“This would mean terminating those uses of BPA involving close contact with humans via food or the environment.”
Same old story
They described the ‘late lesson’ in respect to BPA as the same old story of putting a chemical into widespread use without understanding its health implications, and then trying to resolve public health questions while facing the intense pressure of serious economic consequences.
“The competing urgency of public health and economic stakes puts the scientific process under enormous pressure. In this perspective the story of BPA resembles those of asbestos, polychlorinated Biphenyls (PCB) and Diethylstilboestrol (DES).”