Report Criticizes FDA for Ignoring Risks of Widely Used Chemical

By Christine Cupaiuolo — October 30, 2008

A new report criticizes the FDA for ignoring studies questioning the safety of bisphenol A, a chemical found in many household products. From the Washington Post:

The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found.

In a highly critical report to be released today, the panel of scientists from government and academia said the FDA did not take into consideration scores of studies that have linked bisphenol A (BPA) to prostate cancer, diabetes and other health problems in animals when it completed a draft risk assessment of the chemical last month. The panel said the FDA didn’t use enough infant formula samples and didn’t adequately account for variations among the samples.

Taking those studies into consideration, the panel concluded, the FDA’s margin of safety is “inadequate”. The panel is part of the Science Board, a committee of advisers to the FDA commissioner, and was set up to review the FDA’s risk assessment of BPA.

The FDA’s findings were at odds with a report released in September by The National Toxicology Program, which found that there is “some concern” that BPA can affect neural and behavioral development in fetuses, infants and children. Another study found an association between BPA and cardiovascular disease, Type 2 diabetes and liver-enzyme abnormalities in adults.

The possible connection between chemicals such as BPA and cancer was the focus of a Boston Globe op-ed this week. Rita Arditti, one of the founders of the Cambridge, Mass.-based Women’s Community Cancer Project, writes that “because we still do not know what the causes of breast cancer are, primary prevention remains an elusive goal while mammography and early detection are the focus of attention.”

Here’s what we do know:

Since World War II, the proliferation of synthetic chemicals has gone hand-in-hand with the increased incidence of breast cancer. About 80,000 synthetic chemicals are used today in the United States, and their number increases by about 1,000 each year. Only about 7 percent of them have been screened for their health effects. These chemicals can persist in the environment and accumulate in our bodies. According to a recent review by the Silent Spring Institute in Newton, 216 chemicals and radiation sources cause breast cancer in animals.

Nearly all of the chemicals cause mutations, and most cause tumors in multiple organs and animal species, findings that are generally believed to indicate they likely cause cancer in humans. Yet few have been closely studied by regulatory bodies. There is concern about benzene, which is in gasoline; polycyclic aromatic hydrocarbons, which are in air pollution from vehicle exhaust, tobacco smoke, and charred foods; ethylene oxide, which is widely used in medical settings; and methylene chloride, a common solvent in paint strippers and glues.

There is also broad agreement that exposure over time to natural estrogens in the body increases the risk of breast cancer, so it is important to consider the role of synthetic estrogens in breast cancer development. Many other chemicals, especially endocrine-disrupting compounds – chemicals that affect hormones, such as the ubiquitous bisphenol A, which is found in plastic bottles and cans – are also thought to raise breast cancer risk. Endocrine-disrupting compounds are present in many pesticides, fuels, plastics, air pollution, detergents, industrial solvents, tobacco smoke, prescription drugs, food additives, metals, and personal-care products including sunscreens.

There’s no definitive evidence that these substances cause cancer, but all the information acquired so far makes a strong case for more research and precautionary measures as this research develops. The Massachusetts state Senate this year passed the Safer Alternatives Bill, which would create a program to replace toxic chemicals with safer alternatives when feasible. The bill was not taken up by the House. Advocates for the bill, under the umbrella group Alliance for a Healthy Tomorrow, continue to work on its passage.

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