More research has been released by the United States National Toxicology Program (NTP) as part of a landmark study on the safety of bisphenol A (BPA).
The Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) program is studying a range of potential health effects from exposure to the chemical.
It was initiated by NTP, the National Institute of Environmental Health Sciences (NIEHS) and the National Center for Toxicological Research (NCTR) of the Food and Drug Administration (FDA) to provide data for regulatory decisions.
The draft CLARITY-BPA core study research report was reviewed by an external expert panel in April 2018 and the final version was released last week along with data from academic studies. A report integrating findings from the core study and grantee studies is expected in fall 2019.
BPA is used in the production of polycarbonate plastics such as water and infant bottles and epoxy resins which coat some metal food cans and bottle tops.
The American Chemistry Council (ACC) said the results support the safety of BPA.
“The final report on the CLARITY Core Study strongly supports recent statements from the U.S. FDA that BPA is safe at the very low levels to which people are typically exposed. The scope and magnitude of this study are unprecedented for BPA, and the results clearly show that BPA has very little potential to cause health effects, even when people are exposed to it throughout their lives,” said Steven G. Hentges, Polycarbonate/BPA Global Group of the ACC.
CLARITY-BPA has two components: A “core” guideline-compliant chronic study conducted at NCTR according to FDA Good Laboratory Practice (GLP) regulations and studies of various endpoints, by NIEHS-funded researchers at academic institutions using animals born to the same exposed pregnant rats as the core GLP study.
In February this year when the pre-peer reviewed draft report was released, the FDA said an initial review supports its position that currently authorized uses of BPA continue to be safe for consumers.
At the time, the Endocrine Society expressed disappointment at the FDA’s statement saying it was “premature to draw conclusions” based on one component of a two-part report.
Results from the CLARITY-BPA studies will also be used as part of the European Food Safety Authority’s re-evaluation of the chemical’s toxicity with results expected in 2020.
Last month, new rules that tightened restrictions on the use of BPA in food contact materials in the European Union entered into force.
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