Friday, January 15, 2010

Major Shift In DHHS & FDA Advice On Bisphenol A (BPA)

Jan 15: In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, the Environmental Working Group (EWG) President Ken Cook questions why FDA has remained silent when other Federal public health and environmental agencies have targeted the plastics ingredient bisphenol A (BPA) as a chemical of concern to human health [See WIMS 6/10/08].

Cook wrote, “Other federal agencies have singled out BPA as a major focus of research and potential regulation. In December, the National Institutes for Environmental Health Sciences launched a $14 million research initiative in hopes of filling in the research gaps about the human health risk of BPA. The Environmental Protection Agency has identified BPA as a possible human health threat and priority for risk assessment. Yet the FDA has remained silent. How much more does the FDA need to know to be convinced it must protect the national food supply from further contamination? We urge you to act now to prohibit the use of BPA in food and food containers.”

In a release, EWG notes that Cook’s letter to Hamburg came only days after British scientists reported finding that Americans with high concentrations of BPA in their urine were more likely to report having heart disease or diabetes than people with lower BPA measurements. EWG indicates that authoritative studies by U.S. Centers for Disease Control and Prevention (CDC) found that nearly all Americans test positive for traces of BPA. An EWG study released late last year detected BPA in the umbilical cord blood of 9 of 10 infants born in 2007 and 2008. Cook wrote to Hamburg, “We cannot quantify the cost to our society, in terms of medical bills, lost productivity and troubled lives. But we are sure of this: the price, whatever it is, is too high, and it is unnecessary.”

In major breaking news the Department of Health and Human Services (DHHS) and FDA announced today (January 15) that it has "some concern" about BPA and will undertake new research. In a posting entitled, "Bisphenol A (BPA) Information for Parents" on the DHHS website it was indicated, ". . .recent studies have reported subtle effects of low doses of BPA in laboratory animals. While BPA is not proven to harm children or adults, these newer studies have led federal health officials to express some concern about the safety of BPA. It is clear that the government and scientists and doctors need more research to better understand the potential human health effects of exposure to BPA, especially when it comes to the impact of BPA exposure on young children.

"The Department of Health and Human Services -- through its Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) -- is investing in important new health studies in both animals and humans to better determine and evaluate the potential health effects of BPA exposure, including $30 million in studies at NIH. We expect to have the results of this scientific research in approximately 18 to 24 months. While we learn more, the Food and Drug Administration is supporting current efforts by industry to stop the manufacture of infant bottles and feeding cups made with BPA from the U.S. market. The FDA is also seeking to strengthen its oversight of BPA so the agency can respond quickly, if necessary, when more scientific evidence becomes available."

Representative Henry Waxman (D-CA), Chair of the House Energy & Commerce Committee, issued a brief statement saying, "The announcement today by the Obama Administration regarding BPA is a very positive step that sets us back on a path of science-based decision-making. I am pleased that the Administration is taking the steps necessary to ensure that the public health is protected. We need to do a more effective job of preventing harmful chemicals from entering the marketplace, and for this reason, I look forward to considering reforms of the Toxic Substances Control Act in the coming months."

Environmental Health News (EHN) reported that, "FDA Commissioner Margaret Hamburg said that her agency has embraced the conclusion of the National Toxicology Program, which announced two years ago after a review of the science that there is “some concern” about developmental and reproductive problems in children exposed to BPA." EHN said the announcement is "a major shift for the agency because two years ago it concluded that BPA was safe. The FDA at that time agreed with the plastics industry, which maintained that the animal studies were flawed and that there was no evidence that human babies were in danger."

The American Chemistry Council (ACC) issued a statement in reaction to the Health and Human Services (HHS) and Food and Drug Administration (FDA) announcement on BPA and said, “The HHS statement today confirms that exposure to BPA in food contact products has not been proven harmful to children or adults. However, the agency suggests that more research needs to be done and provided guidance on how parents can choose to limit infant exposures. . .

“ACC and our members are committed to the safety of our products, and we will continue to support laws and regulations that protect consumer safety. While ACC recognizes that HHS and FDA are attempting to address public confusion about BPA, we are disappointed that some of the recommendations are likely to worry consumers and are not well-founded. Plastics made with BPA contribute safety and convenience to our daily lives because of their durability, clarity and shatter-resistance. Can liners and food-storage containers made with BPA are essential components to helping protect the safety of packaged foods and preserving products from spoilage and contamination. ACC remains committed to consumer safety, and will continue to review new scientific studies concerning the safety of BPA.”

Access a release from EWG including the complete letter and an attachment with further details (click here). Access the posting from DHHS with links to additional information (click here). Access the FDA website on BPA research and today's update (click here). Access the statement from Rep. Waxman (click here). Access the article from Environmental Health News (click here). Access the statement and links to more information from ACC (click here).