On February 23, 2018, the U.S. National Toxicology Program (NTP) published the draft research report on the CLARITY-BPA core study (FPF reported). The CLARITY-BPA research program addresses “the potential toxicity resulting from chronic exposure to BPA [(bisphenol A, CAS 80-05-7)] as an indirect food additive.” The draft report only covers the results from the core study which examined health effects from chronic exposure to BPA in rats according to Good Laboratory Practice (GLP) as set out by the U.S. Food and Drug Administration (FDA). The second component of CLARITY-BPA is a set of “studies of various health endpoints, conducted by . . . researchers at academic institutions using animals born to the same exposed pregnant rats as the core GLP study.” The final CLARITY-BPA conclusions, expected in 2019, will integrate the findings of both the GLP study and academic studies.
In the core GLP study, Sprague-Dawley rats were exposed to different doses of BPA prenatally and later directly by oral gavage for a maximum duration of two years. Overall, “BPA produced minimal effects that were distinguishable from background in this study, particularly below [the highest dose of] 25,000 µg BPA/kg bw/day,” the report concluded. In particular, “many of the statistically significant BPA effects were not dose-responsive or occurred in only one dose group,” and “there was not a clear pattern of consistent responses in the stop-dose and continuous-dose study arms.” Some of the significant effects observed include increases in body weight, incidence of mammary gland adenocarcinoma or combination of adenoma and adenocarcinoma, uterine stromal polyps, and follicular cysts in the ovary in females. In males, increases in exfoliated germ cells, lymphocyte infiltration in the epididymis, and hyperplasia of the pars distalis of the pituitary were observed.
In a commentary by the industry group American Chemistry Council (ACC), Steven G. Hentges of the ACC’s Polycarbonate/BPA Global Group stated: “The results of the CLARITY Core study once again demonstrate that BPA is safe at the very low levels to which people are typically exposed.” The ACC highlighted a statement on the draft CLARITY-BPA report released by the FDA noting that “our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers.”
Read more
ACC (February 23, 2018). “New U.S. government research strongly supports BPA safety.”
FDA (February 23, 2018). “Statement from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary Medicine, on National Toxicology Program draft report on Bisphenol A.”
Jon Hamilton (February 23, 2018). “Plastic additive BPA not much of a threat, government study finds.” NPR
Joseph James Whitworth (February 26, 2018). “BPA review supports FDA position on safety.” Beverage Daily
Steve Toloken (February 26, 2018). “Major U.S. study gives ‘currently authorized’ BPA uses clean bill of health.” Plastics News
Reference
NTP (February 2018). “Draft NTP research report on the CLARITY-BPA core study: A perinatal and chronic extended-dose-range study of bisphenol A in rats.” NTP Research Report 9 (9):1-249. (pdf)
