The California Environmental Protection Agency’s Developmental and Reproductive Toxicant Identification Committee (DART-IC) today voted unanimously to list the controversial chemical compound Bisphenol A as a female reproductive toxicant under Proposition 65.The DART-IC is one of two scientific expert panels of the state’s Office of Environmental Health Hazard Assessment (OEHHA).
The expert panel voted 7-0 to add BPA to the Proposition 65 list, contradicting recent pronouncements from the U.S. Food and Drug Administration and the European Food Safety Administration (EFSA).
“We strongly disagree with the DART-IC decision to list BPA under Proposition 65 as a female reproductive toxicant,” said Steven Hentges of the Polycarbonate/BPA Global Group of the American Chemistry Council in a press release.
“The decision is not supported by the extensive scientific record presented to the committee and is completely contrary to explicit input provided by the U.S. Food and Drug Administration. In April, FDA’s acting chief scientist submitted a letter to the DART-IC stating that the results of FDA’s own comprehensive research ‘do not support BPA as a reproductive toxicant.'”
BPA is a key component of polycarbonate and certain epoxy resins widely used in a number plastic and food contact products, such as can liners.
In 2009, the DART-IC considered listing BPA as a reproductive toxicant, unanimously voting against listing the chemical. In its decision, the committee stated the scientific literature did not clearly show BPA causes reproductive toxicity, although the findings from a 2008 report by the National Toxicology Program (NTP) characterized BPA as a chemical of some concern to humans.
Following the DART-IC’s 2009 decision, the Natural Resources Defense Council filed a petition with OEHHA to list BPA based on its–status with NTP.
After three years of deliberation OEHHA filed a notice of its intent to list BPA in February 2013, however, the American Chemistry Council filed a lawsuit to block the listing in March. OEHHA proceeded to listed the chemical in April 2013, but Sacramento Superior Court Judge Raymond Cadai issued a temporary injunction, reversing the listing pending the outcome of the litigation. BPA was listed as a Proposition 65 reproductive toxicant for approximately one week.
On December 18, 2014, Sacramento Superior Court Judge Timothy Frawley ruled that OEHHA did not abuse its discretion when it listed BPA as a reproductive toxicant in April 2013. Judge Frawley refused to grant ACC’s request for a stay pending its appeal of the ruling, but agreed to keep the preliminary injunction in place until the deadline for filing an appeal had passed.
The DART-IC’s reversal from the committee’s previous unanimous vote against listing BPA to a unanimous vote in favor of listing begs the question of what has happened in the past six years to cause such a dramatic shift in the opinions of committee members.
One reason cited for the change in opinion is that there is significantly more independent valid scientific literature to draw from than when the DART-IC considered BPA in 2009. Panelists cited the strong body of evidence that the chemical is toxic to the female reproductive system in both humans and laboratory animals.
Another major difference is that, after an extensive review of the “science on BPA,” the U.S. Food and Drug Administration declared unequivocally in 2014 that exposure to BPA is safe for humans. FDA sent a letter to that effect to the DART Committee panel, urging the committee not to list BPA.
However, this “extensive review” was released with major flaws that rendered the FDA pronouncement of BPA’s safety far from convincing.
A dozen leading scientists who had been working with the FDA on a related project were fuming over the study’s release because they believed the agency had botched the experiment.
On a conference call the previous summer, officials from the FDA and the National Institutes of Health (NIH) had informed these researchers that the lab where the study was housed was contaminated. As a result, all of the animals– including the supposedly unexposed control group—had been exposed to BPA. The FDA made the case that this didn’t affect the outcome, but their academic counterparts believe it casts serious doubt on the study’s findings. “It’s basic science,” says Gail S. Prins, a professor of physiology at the University of Illinois at Chicago, who was on the call. “If your controls are contaminated, you’ve got a failed experiment and the data should be discarded. I’m baffled that any journal would even publish this,” Prins said.
Yet the FDA study glossed over this detail, which was buried in a footnote near the end of the paper. Prins and her colleagues also claim that the paper omitted key information—including the fact that some of the scientists had found dramatic effects in the same group of animals. “The way the FDA presented its findings is so disingenuous,” says one scientist, who works closely with the agency. “It borders on scientific misconduct.”
Although the DART committee members did not publicly acknowledge the study debacle, it had to raise doubts about the FDA’s conclusions.
The committee members after evaluating the available scientific literature unanimously determined that there is sufficient evidence in the studies conducted using generally accepted scientific principles to show that BPA causes female reproductive toxicity.
The listing of BPA as a female reproductive toxicant took effect on May 15.