FDA likely to delay ruling on BPA
Agency may say it needs more time to analyze hundreds of new studies
Despite months of additional study and a self-imposed timetable, the U.S. Food and Drug Administration likely will not release its ruling Monday on the safety of bisphenol A, a chemical used in thousands of household products that has been linked to developmental and behavioral problems.
Sources told the Journal Sentinel the agency instead is likely to ask for more time as its scientists consider hundreds of new studies on the chemical's effects.
Last year, relying on two studies paid for by BPA-makers, the FDA held the chemical was safe for all uses. But the FDA's own science board recommended that the agency had not considered enough of the other studies on the chemical. Earlier this year, the FDA said it would review its findings and set the Nov. 30 deadline.
Advocates for a ban on BPA viewed the prospect of a delay as a good sign, figuring if the FDA plans to maintain its earlier ruling the agency would not need more time.
Additionally, environmentalists were pleased at the recent appointment of Lynn Goldman, a pioneer in research on endocrine-disrupting chemicals and a leading voice for strong environmental health policy, to act as a part-time consultant to the FDA on the chemical.
Advocates of a ban, and packaging company executives who maintain BPA is safe, have anxiously awaited the new FDA ruling.
Even if a new ruling does not come Monday, environmental groups - including the Breast Cancer Fund, Environmental Working Group and the National Resource Defense Council - say they will ask the FDA to immediately impose a public health warning, mandatory labeling of food cans, and an outright interim ban on polycarbonate plastic in food containers.
The FDA regulates food packaging. And because BPA is found in the lining of most food and beverage cans, the agency is charged with the task of saying whether BPA is safe for that use.
The FDA's previous ruling relied on two studies, both of which were paid for by BPA-makers.
E-mails obtained by the Journal Sentinel showed that the FDA's ruling was written in part by lobbyists for the BPA-makers. The e-mails also showed how agency scientists relied on chemical industry lobbyists to examine the chemical's risks, track legislation to ban it and even monitor press coverage.
Last year, more than seven billion pounds of BPA were produced in the United States, bringing in more than $6 billion in sales. BPA, developed as an estrogen replacement and used to make hard, clear plastic, has been found in the urine of 93% of Americans tested.
A decade of concern
Scientists began becoming concerned about BPA about 10 years ago when researchers noticed that lab animals stored in polycarbonate cages were getting much fatter and were more likely to develop breast cancer.
Since then, more than 600 studies have looked at the effects of the chemical.
BPA has been linked in studies on lab animals to breast and prostate cancers, diabetes, heart disease and behavioral disorders.
In 2007, the Journal Sentinel analyzed 258 BPA studies and discovered that more than 80% of the studies that found harm were funded by independent scientists. Nearly all of the studies that found no harm were paid for by industry.
Last year, bowing to consumer demand, several baby bottle manufacturers announced they would stop making products with BPA.
Sunoco, one of six companies to manufacture BPA in the U.S., said it would not sell the chemical to companies without a guarantee that it would not be used to make baby bottles.
Canada declared BPA to be a toxin and outlawed its use in baby bottles.
Similar measures followed in New York's Suffolk and Schenectady counties and the city of Chicago, as well as Minnesota and Connecticut. Massachusetts has issued a health advisory for pregnant woman and babies to avoid products containing BPA.
A federal ban of BPA has been proposed in all food contact items and could be attached to legislation late this year or early next year.
Worries about BPA continue to mount.
A study released this month by Kaiser Permanente found that Chinese factory workers exposed to huge amounts of the chemical were four times more likely to experience erectile dysfunction and seven times more likely have trouble ejaculating.
And a Consumer Reports study released in October and fashioned after tests performed by the Journal Sentinel, found traces of BPA in nearly all food cans, including those marked "BPA Free."
Also see: FDA relied heavily on BPA lobby