August 20, 2008
FDA Decision on BPA Outrages Health Advocates
Scientific studies ignored on bisphenol A evaluation
A broad spectrum of scientists, physicians, and children’s health advocates expressed outrage with the Food and Drug Administration’s (FDA) announcement that bisphenol A – the hormone disrupting chemical found in numerous consumer products including food can linings and plastic baby bottles – is “safe.” In laboratory studies, the pervasive chemical has been linked to obesity, developmental problems, diabetes, risk for heart attack, and several types of cancers including breast and prostate cancer.
“The FDA’s draft assessment relies on just two studies which were funded by the American Chemistry Council (ACC), Dow Chemical, Bayer and other plastics manufacturers. Not only does this assessment ignore the dozens of other studies done by independent scientists which have found evidence of harm, but FDA’s conclusions are in direct conflict with two National Institutes of Health reviews and the actions of its counterpart in Canada,” says Dr. Sarah Janssen, a physician and scientist with the Natural Resources Defense Council (NRDC).
“The chemical industry’s efforts to hide or misrepresent the hazards of their product have been so over the top that even Congress has felt the need to intervene,” said Dr. Jennifer Sass, a scientist with the NRDC. Congress is now scrutinizing the communications between the ACC and a PR firm called the Weinberg Group whose clients have included the alcohol and tobacco industries.
Laura N. Vandenberg, PhD of the Forsyth Center for Regenerative and Developmental Biology, The Forsyth Institute & Department of Developmental Biology, Harvard Medical School says, “ There is great concern in the scientific community over the FDA’s use of only two published studies, ignoring more than 100 that show effects of low dose exposure. While the FDA stated, “[W]e will continue to consider new research and information as they become available”, it is puzzling to observe this agency ignoring the wealth of studies already available.
The studies that the FDA are using for risk assessment purposes are industry-funded, use antiquated experimental techniques, and have significant scientific flaws. Meanwhile, the FDA has rejected the findings from government-funded researchers using state-of-the-art techniques and experimental designs that have been replicated in other labs, proving them to be valid. Scientists working on BPA are calling for an investigation into the decisions made by US and EU regulatory agencies, particularly because the Canadian Ministry of Health and Ministry of the Environment both recently declared BPA a toxic chemical and the US National Toxicology Program stated that exposure of human infants was in the range that caused harm in animal models.”
Earlier this year, Congressman John Dingell (D-MI) said, “There are serious health concerns about whether bisphenol A is safe, not only for adults, but for children and infants. The tactics apparently employed by the Weinberg Group raise serious questions about whether science is for sale at these consulting groups, and the effect this faulty science might have on the public health.”
Congressman Edward J. Markey (D-MA), senior member of the House Energy and Commerce Committee says, “The FDA assessment stands in stark contrast to dozens of peer-reviewed scientific papers that have found real health risks associated with exposure to BPA. On issue after issue, the Bush Administration casts aside concerns about public health and consumer protection in favor of commercial interests that benefit corporate America. Over the past eight years, the Bush Administration’s mantra has been “In industry we trust.” Since the regulators are asleep at the wheel, I’ve introduced legislation to ban BPA in all food and beverage containers, and will continue to work to ensure that it is enacted into law.”
Union of Concerned Scientists conducted a poll with FDA scientists that indicated, in general, broad industry interference within the agency, and documented intimidation of scientists who may not have agreed with industry promoted decisions at the agency.
“The FDA is bowing to the chemical industry’s influence, and trying to convince the American public that this chemical is OK. There is clear and credible evidence, and more scientific studies, showing links to the very health effects we see on the rise today,” says Christopher Gavigan, executive director of Healthy Child, Healthy World.
Many observers are seeing parallels between the tobacco industry’s use of PR firms and hired experts to deceive the American public about harm from smoking and what is going on with the chemical industry today.
“The profits keep growing for Dow Chemical, General Electric, and other chemical and petrochemical companies in the American Chemistry Council,” says Mia Davis with the Workgroup for Safe Markets. “Our public health is of greater importance than the wealth of these corporations, and the FDA needs to recognize that.”
“Scientists, parents and public health advocates agree,” said Janet Nudelman, Director of Program and Policy for the Breast Cancer Fund, “There is more than enough science to be concerned about exposure to even exquisitely small amounts of BPA.”
“It is unbelievable to me that thirty years after toxic contamination was causing harm to 900 families at Love Canal and both state and federal governments only acted after the community forced their hands, that we see today the same unacceptable inaction by our federal government. When will government learn to err on the side of caution instead of risk equations?” said Lois Gibbs, founder and executive director of the Center for Health, Environment and Justice.
"A baby bottle that contains chemicals which may cause obesity, developmental problems, diabetes or cancer is hardly 'safe,'" said Kristin Rowe-Finkbeiner, Executive Director of MomsRising.org. "When people buy products for their children, they expect those products to be free of cancer-causing agents and other toxins. For the FDA to undermine that belief by labeling as safe products containing chemicals that can cause serious damage to growing kids is unconscionable and a complete abdication of their responsibility to the American public."
“At the end of the day parents don’t want to have to do a research project to find safe products for their families,” states Lindsay Dahl from Minnesota based Healthy Legacy, “they expect and depend on government agencies like the FDA to err on the side of safety. For parents across the nation, this is truly disappointing.”
Available for Interviews
Sarah Janssen, MD, PhD, MPH is a science fellow in the Health and Environment program at Natural Resources Defense Council.
Jennifer Sass, PhD, senior scientist, Natural Resource Defense Council 202.289.6868 firstname.lastname@example.org
Laura N. Vandenberg, PhD, Postdoctoral Fellow, Levin Lab, Forsyth Center for Regenerative and Developmental Biology,
The Forsyth Institute & Department of Developmental Biology, Harvard Medical School Tel. (617) 892-8464
Anila Jacobs, MD, senior scientist with Environmental Working Group, to schedule an interview with Anila, contact Alex Formuzis (202) 939-9140
Janet Nudelman, Director of Program and Policy for the Breast Cancer Fund to schedule an interview with Janet Nudelman, please contact Shannon Coughlin, 415.336.2246, email@example.com
Mia Davis Co-Coordinator, Workgroup for Safe Markets 617.338.8131 ext 201 firstname.lastname@example.org
Kathleen A. Curtis, Policy Director, Clean New York, a project of Women's Voices for the Earth 518 6698282 (cell) 518 355.6202 (home office) http://www.clean-ny.org
Sarah Uhl, Coordinator of the Coalition for a Safe & Healthy Connecticut 860.232.6232 (office) / 860.882.9950 (cell) email@example.com
Jane Haley-Harris, Executive Director of the Oregon Center for Environmental Health; 503.233.1510; firstname.lastname@example.org
Lindsay Dahl, Healthy Legacy Minnesota, 612.870.3458 www.healthylegacy.org , email@example.com
Christopher Gavigan, CEO / Executive Director, Healthy Child Healthy World 310. 820. 2030 www.healthychild.org
Lois Gibbs, founder, Center for Health Environment and Justice. To schedule an interview with Lois, contact Dianna Wentz
703.237.2249, ext. 19 412.512.3208 (cell) firstname.lastname@example.org
Kristin Rowe-Finkbeiner, Executive Director, MomsRising.org. For interviews contact Gretchen Wright 202. 371.1999
Union of Concerned Scientists FDA Scientists Survey
House Committee on Energy and Commerce
Dingell, Stupak Investigate American Chemistry Council
House Committee on Government Oversight Letters Regarding BPA
Baby’s Toxic Bottle Report
(Including BPA fact sheet)
Center for Health, Environment and Justice