More Clarity that BPA is Safe
The WasteWatcher
The long-awaited final core study on Bisphenol A (BPA), a compound used to produce strong plastic products and epoxy resins, has been released. On September 28, the National Toxicology Program (NTP) announced that the CLARITY-BPA Core Study and Primary Data from the CLARITY-BPA Grantee Studies were available. The core study confirms what has been known for years: BPA is safe.
The Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity, or CLARITY, is composed of the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH), NTP, and the National Center for Toxicological Research (NCTR) at the Food and Drug Administration (FDA). It was created in 2012 to settle once and for all if there are any potential health effects from exposure to BPA.
The core study was conducted by NCTR scientists and consistent with federal regulatory and statutory guidelines for toxicity, and the grantee studies were led by university researchers. The grantees tested a wider range of health endpoints, such as genetic impacts, cardiovascular disease, and behavior. The grantees, some of which are strong opponents of BPA, were unaware, or blinded, on the animals’ level and route of exposure to BPA, as well as the animal tissues provided for additional study. All the animals in the core and grantee studies were raised in the same conditions and exposed to the same doses of BPA.
In other words, this was a highly controlled study.
CAGW’s March blog discussed a draft core study report on BPA, which showed that the compound, which is used to produce strong plastic products and epoxy resins, is safe. At that time, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., said that the report “supports our determination that currently authorized uses of BPA continue to be safe for consumers. The report also builds upon the already extensive data collected in the FDA's 2014 assessment of the safety of BPA.”
CAGW’s May blog discussed an April 2018 external peer review of the draft core study by a panel of scientific experts. If there was a serious problem with how the core study was conducted and proof that BPA was harmful, there would have been headlines. There weren’t any.
Environmental extremists have successfully whipped up an outlandish fear of BPA, convincing millions of people across the globe it was one of the most dangerous compounds on Earth. Yet the release of the core study, which shows BPA is safe, and any negative results about the grantee studies have hardly made any news. Not only were these groups silent about the core study’s results and the available primary grantee data, the Endocrine Society also had nothing to say after it warned the FDA in February that it was “premature to draw conclusions based on the release of one component of a two-part report.”
The only news organization that reported on the final study (as of the publication of this blog), was NPR, through a September 13 on-line preliminary presentation by the NCTR. The bottom line in the story was that low doses of BPA given to hundreds of rats "did not elicit clear, biologically plausible adverse effects” and rats given BPA at exposures meant to replicate human exposure showed “no pattern indicating any health or behavior problems.” Only rats “that got at least a thousand times more BPA than consumers are exposed to showed effects similar to those produced by the hormone estrogen. These included changes to the reproductive system and a greater risk of reproductive tumors.”
By the fall of 2019, the CLARITY core and the finalized grantee studies will be integrated into one final document. Meanwhile, spending millions of tax dollars more on BPA research is a complete waste of money. These NIH grant dollars could be better spent on any other useful research.
The NIEHS has been in a sibling fight with the FDA for years over BPA’s safety, as CAGW laid out in a 2014 Waste Watcher, “Dueling Agencies.” The FDA continues to be perfectly capable of monitoring the use of BPA without being undermined by the NIH and its grantees.