The professional organization for scientists and physicians in the sector expressed ‘disappointment’ with the US Food and Drug Administration’s (FDA) position that results support previous determinations the chemical is not harmful.
The National Toxicology Program (NTP) released a pre-peer review draft report on results of the two-year rodent study examining potential effects of BPA on health.
Call to reserve judgement
The work, by scientists at the FDA’s National Center for Toxicological Research (NCTR) and the National Institute of Environmental Health Sciences (NIEHS), is part of the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).
CLARITY-BPA conclusions are expected next year.
The Endocrine Society said policymakers and regulators should reserve judgment until the full report is released.
It added the NCTR study did not examine BPA’s impact on brain development but focused on affects on growth, weight and tumour development.
Laura N. Vandenberg, Endocrine Society spokesperson, said the draft report included results of one government study with a partial data set and has yet to undergo peer review.
“It is premature to draw conclusions based on the release of one component of a two-part report,” she said.
“The endpoints studied here do not encompass the full effects of endocrine-disrupting chemicals, especially because the whole point of this study was to compare the NCTR’s endpoints with more sensitive effects evaluated by endocrinologists.
“Furthermore, the NCTR’s data does not provide assurance of BPA’s safety. They found certain BPA doses are linked to a higher rate of mammary gland tumours, which is concerning.”
FDA, ACC and PlasticsEurope responses
FDA said the review supports its position that authorized uses of BPA in food containers and packaging continue to be safe for consumers.
“Overall, the study found “minimal effects” for the BPA-dosed groups of rodents,” said Stephen Ostroff, deputy commissioner for foods and veterinary medicine at FDA.
“The report did identify some areas that may merit further research, such as the increase in occurrence of mammary gland tumours at one of the five doses, in one of the groups. But the significance of these findings will be assessed through the peer review process.”
The American Chemistry Council (ACC) and PlasticsEurope said results supported the safety of BPA.
“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,” said Steven G. Hentges, Polycarbonate/BPA Global Group of the ACC.
“This study is the largest study ever conducted on BPA, and the results indicate that BPA has very little potential to cause health effects even when people are exposed to it throughout their lives.”
The European Food Safety Authority (EFSA) is to re-evaluate BPA later this year with results expected in 2019.
The European Commission recently set regulation, which applies from September, to tighten restrictions on BPA in food contact materials (FCMs).
Migration limit has been strengthened 12-fold from 0.6 mg/kg to 0.05 mg/kg in food contact plastics and it will be prohibited in food contact varnished or coated materials for infants and young children.