On July 20, 2018, the news and opinion website HuffPost published an article discussing the ongoing safety assessment of bisphenol A (BPA, CAS 80-05-7). The six-year project, called Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA; FPF reported), was initiated by the National Institute of Environmental Health Sciences (NIEHS) and the U.S. Food and Drug Administration (FDA) in 2012. CLARITY-BPA “was designed to be a two-armed study: One would . . . us[e] the traditional guidelines to look for overt changes in things like body weight, and the other would test more subtle endpoints chosen by academic scientists,” journalist Lindsey Konkel explains.
The study was “meant to clear up confusion over BPA’s potential health harms.” However, it could also “have major consequences for the way the FDA assesses the safety of BPA and many other chemicals used in food packaging and processing.” The approaches used by regulatory and academic scientists for toxicity testing differ fundamentally, as detailed by the independent consultant Maricel Maffini: “Academics go where the data takes them, whereas regulatory science is more prescribed.” Regulatory guidelines that are currently used to assess food additives and food-packaging related chemicals were devised in the 1970s and “have fallen behind the scientific knowledge,” Maffini adds. For example, the guidelines lack tests investigating a chemical’s potential to interact with the endocrine system and often overlook more subtle effects, such as neurological deficits that could manufest as autistic or attention deficity hyperactivity disorder (ADHD)-like behaviors.
Although it makes sense for government agencies to resist “any hastily made changes” to remain “less susceptible to undue influence from politicians, industry and special interest groups,” this approach means that the results of academic studies are often not considered during risk assessments. The article provides two examples of BPA assessments from 2008 and 2014 that have drawn their conclusions mainly from a few industry-based studies and neglected most of the peer-reviewed, federally funded research (FPF reported).
The release of a draft report of the CLARITY-BPA study by the FDA in February 2018 (FPF reported) is criticized in Konkel’s article since the published results were not rigorously peer-reviewed and academic scientists have yet to publish their results to obtain a comprehensive picture. In addition, FDA’s conclusion “that BPA is safe for the currently authorized uses in food containers and packaging” has been challenged: The interpretation of the results by FDA is questioned by academics, professional organizations and a foreign health agency in public comments because the underlying data indicated slightly increased rates of mammary tumors, kidney cysts and changes to the cells of the prostate and vagina when rats were exposed to low levels of BPA – which is in agreement with data from academic studies. Another point of criticism is the inappropriate comparison of animals from the lowest BPA-dose group from the CLARITY-BPA study with a control group from a previous experiment.
The academic researchers have scheduled the release of their CLARITY-BPA results for August 2018. Subsequently, the National Toxicology Program will review and integrate the two sets of data and publish a recommendation, which could not only affect the future use of BPA, but also introduce more sensitive toxicity tests for risk assessments.
Lindsey Konkel (July 20, 2018). “Is BPA making us fat, anxious and sick? A new effort to find the answer may be falling apart.” HuffPost