Callum Little examines the on-going BPA debate. With a report landing from the National Toxicology Program, he asks when will we see the end of the BPA debate?
The safety of bisphenol A (BPA) has been a contentious topic in recent years with numerous studies and research projects taking place to try and definitively answer whether there is a health risk to humans associated with the chemical.
BPA is used in the production of certain plastics such as polycarbonates and epoxy resins, which are often used to make food packaging. It is also used in the production of polymers for medical devices such as catheters and implants, and some dental devices.
There was hope of a definitive answer to the safety of BPA after the establishment of the Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity (CLARITY-BPA) – a research collaboration established by the National Institute of Environmental Health Sciences (NIEHS) and the Federal Drug Administration (FDA).
CLARITY-BPA had two components: A Core Study that was conducted in-house by the FDA, would test the potential of BPA toxicity in pregnant rats. There was a second component of Grantee Studies that would be conducted by researchers at academic institutions, to carry out testing using animals raised in the same conditions and exposed to the same doses of BPA as the Core Study.
Despite the recent publication of the results from the Core Study suggesting that there were a number of statistically significant endpoints, the NIEHS released a statement that played down the results on a basis that the BPA doses some rats were administered were overtly-high. The Institute said: “These exposure levels were many times higher than people typically receive” and that when rats had health effects at lower doses, the authority was, “uncertain whether the changes were related to BPA exposures.”
John Butcher, NTP senior scientist said: “To fully understand the Core Study results, we need to compare these traditional guideline studies with results from the Grantee Studies, which looked at a broader range of health conditions. This will be done in the final integrated report next year.”
The results of the CLARITY-BPA guideline study, conducted by the FDA were published in a draft report by the National Toxicology Program (NTP)in February 2018. Dr. Stephen Ostroff, deputy commissioner for foods and medicine, FDA, proclaimed: “Our initial review supports our determination that currently authorised 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.”
The FDA was criticised by some CLARITY grantees and scientific groups such as the Endocrine Society, after issuing this statement regarding the pre-peer reviewed results from the Core Study. The agency originally promised to refrain from drawing any conclusions until the full results of the CLARITY-BPA study were published. The agency stated after reading the report that BPA posed no adverse health risk to humans.
Now that the peer-reviewed study report has been released, some research institutes are stating that the FDA’s continued assertion that BPA is safe for human consumption is now contrary to the evidence available to agency.
In a webinar organised by Carnegie Mellon University’s Institute for Green Science (IGS) and Environmental Health Sciences (EHS), a group of leading BPA researchers disagreed with the FDA’s dismissal of research findings that showed low levels of BPA exposure resulted in ill-health effects.
BPA in medical devices
The safety of using BPA in medical devices was raised by the European Commission, and subsequently referred to the European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in 2015.
Comprised of independent scientists and experts who serve as members of a working group, SCENHIR issued the following statement in the committee’s report on ‘The safety of the use of BPA in medical devices’: “Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials.”
The CLARITY-BPA study is ongoing and a report integrating findings from the Core Study and Grantee Studies is expected in Autumn 2019.