Washington , D.C. – Congresswoman Rosa L. DeLauro (CT-3) pressed the Science Board of the Food and Drug Administration to expand its inquiry of bispenol A (BPA) beyond plastic baby bottles, food containers, and water bottles to also assess the safety of BPA in medical devices in a letter to Frank M. Torti, M.D., the Principal Deputy Commissioner and Chief Scientist at the agency. Additionally, because it is unclear which medical devices contain the chemical – outside of dialysis tubing, blood oxygenators, and dental sealants – DeLauro called on the Board to identify all medical devices that contain BPA, as FDA’s counterpart in Canada has done.

“As you well know, scientific studies have linked BPA to neurological and behavioral problems in youngsters as well as certain cancers, diabetes and obesity. If these conditions were caused by BPA leaching from containers and bottles into the body, the potential risks posed to patients by BPA leaching from medical devices, especially implantable ones, would be very significant,” DeLauro writes in the letter. “I strongly urge you to expand your request, and have the Science Board also assess the safety of BPA in medical devices.

The letter also notes that BPA appears to have an especially negative impact on the health of women, referencing a study by the National Institute of Environmental Health Sciences that determined that BPA can cause reproductive damage.

DeLauro concludes, “In order to fully understand the safety risks associated with products containing BPA and its possible link to medical problems, we must obtain all relevant information related to the chemical so that conclusions can be reached based on sound science.”

Below is the text of the letter.

June 16, 2008

Frank M. Torti, M.D.

Principal Deputy Commissioner and Chief Scientist

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Dear Dr. Torti:

I applaud your effort in urging the Science Board to establish a subcommittee to assess the safety of bisphenol A (BPA) in some plastic baby bottles, food containers, and water bottles. While this initial inquiry into BPA has been rightfully focused on its effect on children and infants, I believe that it is equally important that studies are conducted on the toxicity of this agent in medical devices, especially those targeted toward women.

As you well know, scientific studies have linked BPA to neurological and behavioral problems in youngsters as well as certain cancers, diabetes and obesity. If these conditions were caused by BPA leaching from containers and bottles into the body, the potential risks posed to patients by BPA leaching from medical devices, especially implantable ones, would be very significant.

Further compounding this problem is that it is unclear which medical devices contain BPA. While it is known that dialysis tubing, blood oxygenators, and dental sealants contain the chemical, it is believed that there are many more medical devices that have been manufactured with BPA. Unfortunately, since this information is not public, there is no way for patients to know the risks they are facing. Last month, FDA’s Canadian counterpart, Health Canada , issued a rule requiring all companies to identify which of their products include BPA. It would seem advisable for FDA to issue a similar requirement.

Based on some initial studies, BPA appears to have an especially negative impact on the health of women. The Journal of Cancer Research recently found that BPA causes normal, non-cancerous human breast cells to express gene characteristics of aggressive breast cancer cells. Another study by The National Institute of Environmental Health Sciences determined that BPA can cause reproductive damage similar to the anti-miscarriage drug diethylstilbestrol, which was given to pregnant women from the 1940s to the 1970s. As you may recall, diethylstilbestrol was later found to cause infertility and reproductive cancers among children born to women who took the drug.

Your request that the Science Board undertake an assessment of the safety of BPA in certain products was a wise course of action given the presence of BPA in our daily lives. In addition to the products mentioned above, BPA also is present in eyeglasses, common household goods, and even in thermal paper, which is used for printing receipts at gas stations.

However, I am concerned that your request for the Science Board to assess only the safety of baby bottles, food containers, and water bottles may not be adequate. I strongly urge you to expand your request, and have the Science Board also assess the safety of BPA in medical devices. I also would urge that you request the Board to identify all of the medical devices that contain BPA, similar to the recent action undertaken by Health Canada .

In order to fully understand the safety risks associated with products containing BPA and its possible link to medical problems, we must obtain all relevant information related to the chemical so that conclusions can be reached based on sound science.

Thank you very much for your attention to this issue, and I look forward to receiving a prompt reply.

Sincerely,

ROSA L. DeLAURO

Chairwoman

House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration,

and Related Agencies

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