U.S. FDA to reconsider BPA safety issue

WASHINGTON (Aug. 20, 3 p.m. ET) — The change in leadership at the Food and Drug Administration has prompted a review of whether to change its long-held stance that there is not enough data to support a ban on the use of bisphenol A in food packaging — in particular, baby bottles.

An FDA spokesman said commissioner Margaret Hamburg, who moved into the top slot three months ago, will make a decision by Nov. 30 on “how to proceed” after receiving a draft report and recommendations from the agency’s Center for Food Safety and Applied Nutrition.

A number of laboratory studies have linked BPA to birth defects, low birth weights, cancer, early puberty and other health problems in rats, triggering some states and cities to take legislative action.

Earlier this year, Connecticut, Minnesota, Chicago and Suffolk County, N.Y., banned the sale of polycarbonate baby bottles, food containers and cups that contain BPA.

The Suffolk County ban went into effect in July. The Minnesota ban goes into effect Jan. 1, 2010; the Chicago ban on Jan. 31, 2010; and the Connecticut ban on Oct. 1, 2011. The Connecticut ban also applies to infant formula cans and all reusable food and beverage containers.

A proposed ban on BPA is still pending in the California legislature.

The six major baby bottle manufacturers in the U.S earlier this year agreed not to use BPA in polycarbonate baby bottles, making BPA bans largely symbolic for plastic bottles. But an FDA decision could have a huge impact on manufacturers of canned foods that use containers lined with BPA.

The willingness to look at additional scientific data is a 180-degree shift from eight months ago, when FDA reiterated its long-held stance that there was not enough data to support a ban on BPA in food packaging.

At that time, FDA said it would conduct “a large research effort” that could last several years in order to assess the effect on BPA on laboratory animals and to examine the cumulative exposure a person faces from a variety of items that contain BPA, including food and beverage containers, coatings on gel tablets and plastic medical devices such as tubing.

FDA said CFSAN was currently reviewing more than 100 studies, many of which evaluate the potential risk for low-dose exposure to BPA. One of the recommendations of the FDA Science Board subcommittee last October had been to review such studies.

An FDA spokesman said the review will focus on the potential adverse human health effects that were considered to be of some concern in the National Toxicology Program report in September 2008.

That NTP report was dismissed by previous leadership at FDA. Among other things, NTP had suggested that parents might want to reduce the exposure of infants to products that contain BPA.

The agency had received stinging criticism in October for rejecting a report by an FDA Science Board subcommittee which said that FDA’s position that BPA is not harmful ignores critical studies and that the margins of safety the agency defines as adequate “are, in fact, inadequate.”

Eleven safety agencies around the world have said that BPA is safe for use in food contact applications.

There's something unclear. Your words support the misconception that BPA is an INGREDIENT in PC products, when it is really just a BUILDING BLOCK for the PC molecule. The public image sees it as an ingredient, hence necessary, and thus all PC bottles are suspect.

Do you mean that the makers will not use PC made with BPA (using another intermediate instead, hence no BPA residual content)?

Or have they agreed to keep the residual level below some critical point in resin made as usual with BPA? (We've been there before with vinyl chloride in the 70s.)

This is a separate issue from whether BPA is or is not harmful. The differences are critical, and if indeed no BPA is used to make the polymer (and the alternate is not equally suspect) this should be widely and proactively publicized.

Allan Griff, Consulting Engineer and proactive defender of plastics as ENVIRONMENTALLY beneficial.

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