The 8th Food Packaging Forum (FPF) workshop on “Improving the chemical safety of food contact articles: Linking policy-making with scientific research” took place on October 21-23, 2020. This year the FPF workshop was a web-based event only, which nevertheless provided a good opportunity for networking and discussions among the more than 200 registered participants.

On October 22, 2020, Laura Vandenberg, Associate Professor at University of Massachusetts Amherst, US, analyzed and interpreted data generated within the Consortium Linking Academic and Regulatory Insights on bisphenol A Toxicity (CLARITY-BPA) (FPF reported).

After introducing the different applications of bisphenol A (BPA, CAS 80-05-7) that may lead to human exposure, Vandenberg emphasized that more than 100 scientific studies show associations between BPA exposure and human diseases. Then she gave a short crash-course in chemical safety testing that traditionally measures visible and obvious effects in many animals at rather high doses (e.g., changes in organ and body weight, clinical signs, histopathological differences).

Prior to CLARITY-BPA, guideline studies reported that high doses of BPA (up to 50 mg per kg bodyweight (bw) per day) altered the health of the kidneys and livers of test animals, Vandenberg noted. In contrast, hundreds of animal studies done in academic labs described adverse effects of BPA related to reproduction, health and disease of the mammary gland, the immune system, metabolic endpoints, brain structure, and neurobehavior. Vandenberg explained that the different results between guideline and academic studies could be based on differences in sample sizes, sensitivity, relevance to disease, and study reliability.

CLARITY-BPA was initiated to bridge these gaps by looking at the same questions with different hypotheses and by integrating the results of guideline and academic studies. By summarizing the results of the guideline studies, Vandenberg showed adverse effects in the lowest dose group (2.5 µg BPA/kg bw/day), including an increased rate of mammary cancer cases and prostate inflammation. To Vandenberg’s surprise, prior guideline studies did not see these effects. In addition, the US Food and Drug Administration (FDA) considered these low-dose effects not as concern and adverse outcomes were only included in the risk assessment if they increased with dose. In the academic studies, the same animals were examined by sending samples to 13 different laboratories. Again, diverse effects of BPA were found in all dose groups. According to Vandenberg, CLARITY-BPA was still an imperfect study due to problems with gavaging animals, BPA contamination, the use of historical controls, difficulties in reproducibility, and underpowered academic studies (FPF reported).

In her final remarks, Vandenberg said that we need to back-away from the single data sets to recognize patterns in the whole picture. She referred to a study by Heindel and colleagues stating that the lowest doses that were administered in the CLARITY-BPA study have consistently elicited effects across organs (FPF reported).

Read more

Laura Vandenberg (October 22,2020). “Lessons learned from Clarity-BPA.” (YouTube; pdf)