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FDA Denies Petition to Ban BPA in Food and Beverage Containers

The U.S. Food and Drug Administration on Friday denied a petition seeking to ban bisphenol-A, commonly known as BPA, from food and beverage packaging, but the agency said it continues to support research examining the safety of the chemical.

BPA has been used for decades in a broad range of food and beverage containers, including sippy cups, cans and baby bottles. Though standardized toxicology tests have indicated that the chemical is safe, a growing body of research looking at subtle effects at low levels of exposure to the endocrine disruptor has led the Natonal Toxicology Program at the National Institutes of Health and FDA to conclude that they have “some concern” about the potential effects “on the brain, behavior, and prostate gland in fetuses, infants and young children.”

FDA said that while it was denying a petition by the Natural Resources Defense Council (NRDC) to ban BPA, on the basis that it did not provide sufficient scientific evidence, the agency is continuing to study the issue with the National Institute of Environmental Health Sciences.

“I cannot stress enough that this is not a final safety determination on BPA,” said FDA spokesman Douglas Karas. “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”

NRDC scientist Sara Janssen expressed disappointment in the agency’s decision: “BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call,” she said. “The agency has failed to protect our health and safety ­- in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.”

FDA and NIEHS are in the middle of a $30 million research initiative attempting to shed light on BPA safety. The agency said it was working on finishing another updated safety review based on the new studies. So far, FDA’s research has found that human infants’ exposure to BPA is between 84 and 92 percent less than previously estimated and that the level of BPA from food that could be passed on by pregnant rodents to their unborn offspring is “so low it could not be measured.”

“Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure,” said FDA in a brief overview of the latest research. “People of all ages process and rid their bodies of BPA faster than the rodents used as test animals do.”

The FDA had until Saturday to respond to a petition filed by NRDC, according to a court order issued in December 2011. The group petitioned FDA three years ago, requesting that BPA be prohibited in food packaging. The NRDC cited human health concerns, and eventually filed suit to force the agency to respond.

Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, a conservative think tank, said he believes FDA did the right thing by denying the petition.

“The risk-averse FDA would not have left a product on the market if it were dangerous, as NRDC has been claiming,” said Stier in a statement. “At this point, this issue should be laid to rest.  The federal government has spent tens of millions of dollars investing in research on BPA, already one of the most well-studied chemicals on earth, and the FDA has squandered its limited resources on multiple safety assessments, including the one litigated by NRDC.”

The packaging industry response was divided along unsurprising lines.

The North American Metal Packaging Alliance (NAMPA), which represents canned food makers, welcomed the news, while the glass industry expressed disappointment.

NAMPA said that FDA’s decision reiterated that BPA, “at current levels of exposure, is safe for use in food contact applications for people of all ages, including infants and children.”

Lynn Bragg, president of the Glass Packing Institute, pointed out that glass is the only widely used packaging designated “generally recognized as safe, or GRAS, and can help consumers reduce their toxic health concerns.”

In its letter to NRDC, FDA said it appreciated the group’s concern about BPA and added that it takes that concern seriously.

“FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA,” read the letter. “FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA’s assessment and future regulatory decisions about BPA.”

Many companies, including the Campbell Soup Company, have already discontinued or begun phasing out the use of BPA in their packaging and products.

 

© Food Safety News
  • Steve

    “The dose makes the poison” the toxic-chemicals-apologists love to say — and they’ve put in place “safety thresholds” that allow deadly materials into everyday commerce.
    Except the industry science (rubber -stamped by our “watchdog” agencies) that is used to justify same is often suspect. The result is tens of thousands of these toxic substances have been allowed into our food, household cleansers, flame retardants, cosmetics, toothpaste, etc, etc — as well as huge amounts of BPA in can liners and kid’s sippy cups…
    And while industry promoters such as the Risk Analysis Division at the National Center for Public Policy Research (a conservative think tank) makes sure FDA stays in a constant study mode without a ban in sight, along comes definitive research that blows the safe threshold limits that were established for hormone disrupters like BPA out of the water…
    Campbell’s soup got the message from consumers. Maybe now the packaging industry will have to call in Rick Perry and some other Governors to try and convince the public otherwise…

  • Alexis

    Science and common sense prevail at FDA once again. Now we will have to listen to the whining and whimpering of the Chicken Little crowd who didn’t get their way.

  • Sara

    Sure that makes sense. Let’s keep using something questionable while spending millions of dollars on biased research instead of just using a safer solution. Sounds like the best use of our government resources and the best care for the American public. As always, thanks FDA.
    I’m equally impressed how perpetuating a potentially dangerous public health risk is cast in such a positive light by the author of this article. The phrase “what you do speaks so loudly I can’t hear what you say” should apply equally to people as well as government agencies. Either we care about the health concerns, so we stop using something we “don’t know enough about to know whether it’s safe” until we DO know, or we admit we really don’t care and we continue using it. Let’s not portray that the FDA really cares when they clearly don’t. This facade of grey area and a pensive FDA is a joke.

  • Dorv562

    Steve unfortunately represents the thousands of scientifically ignorant citizens that regulators and environmentalist groups depend upon to regurgitate their anti-business propaganda. Like so many others, Steve lacks mathematical understanding, business acumen and just plain common sense. When one does not understand science, even at a high school level, he should not editorialize against it and show the world how stupid he really is.

  • Steve

    RE: my post on the effects of low-dose hormone disrupters in BPA — the URL reference I submitted to back up my post got scrubbed, somehow…
    See:
    Current Chemical Testing Missing Low-Dosage Effects of Endocrine-Disrupting Chemicals
    ScienceDaily (Mar. 29, 2012) —
    Here’s a few quotes from the article:
    “Endocrine-disrupting chemicals (EDCs) — such as BPA — can show tangible effects on health endpoints at high dosage levels, yet those effects do not predict how EDCs will affect the endocrine system at low doses, according to a recent study accepted for publication in The Endocrine Society’s Endocrine Reviews. Study authors say current definitions of low-dosage as used by the U.S. Environmental Protection Agency (EPA) do not fully take into account the unique influence that low doses of EDCs have on disease development in humans.”
    Endocrine-disrupting chemicals are substances in the environment that interfere with hormone biosynthesis, metabolism or action resulting in adverse developmental, reproductive, neurological and immune effects in both humans and wildlife. The current report found that low doses of EDCs, which are comparable to the average person’s environmental exposure to these chemicals, can result in significant health effects.
    “Whether low doses of EDCs influence disorders in humans is no longer conjecture as epidemiological studies show that environmental exposures to EDCs are associated with human diseases and disabilities,” said Laura Vandenberg of Tufts University in Medford, Mass. and lead author of the study. “Current testing paradigms are missing important, sensitive endpoints and fundamental changes in chemical testing and safety determination are needed to protect human health.”
    …The report provides a detailed discussion on the mechanisms responsible for generating this phenomenon, plus hundreds of examples from the cell culture, animal and epidemiology literature.
    “Low-dose effects are remarkably common in studies of natural hormones and EDCs,” said Vandenberg. “We recommend greatly expanded and generalized safety testing and surveillance to detect potential adverse effects of this broad class of chemicals. Before new chemicals are developed, a wider range of doses, extending into the low-dose range, should be fully tested.”
    Journal Reference:
    Laura N. Vandenberg, Theo Colborn, Tyrone B. Hayes, Jerrold J. Heindel, David R. Jacobs, Jr., Duk-Hee Lee, Toshi Shioda, Ana M. Soto, Frederick S. vom Saal, Wade V. Welshons, R. Thomas Zoeller, and John Peterson Myers. Hormones and Endocrine-Disrupting Chemicals: Low-Dose Effects and Nonmonotonic Dose Responses. Endocrine Reviews, 2012 DOI: 10.1210/er.2011-1050″