Why BPA signs still point in different directions

November, 2010

Eric F. Greenberg | Attorney-at-Law

One was reminded of a sad fact by recent developments regarding Bisphenol A, or BPA, the plastics additive used in some metal can liners and hard plastics that has been the subject of controversy over its alleged health effects at common levels of exposure. That fact is, science often loses to perception.

During the last week of September, the European Food Safety Authority (EFSA) announced that it would reaffirm its position with respect to BPA exposure. It said in a statement, “following a detailed and comprehensive review of recent scientific literature and studies on the toxicity of bisphenol A at low doses, [scientists at EFSA] conclude they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake [TDI] for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion. The panel also states that the data currently available do not provide convincing evidence of neurobehavioral toxicity of BPA.”

The primary focus was endocrine activities in the body, and while EFSA said it also found studies that “suggest associations between exposure to BPA and coronary heart disease and reproductive disorders,” it said the design of those studies did not allow conclusions about causation.

One member of the EFSA review panel disagreed with its conclusions and issued a minority opinion “saying some recent studies point to uncertainties regarding adverse health effects below the level used to determine the current TDI.” That panel member would like to see the current TDI declared temporary, even though the member agrees “these studies could not be used to establish a lower TDI.”

At press time, EFSA’s report was set to be evaluated by the European Commission, and future action was reportedly still possible, especially regarding infant exposures.

While the money-shot of EFSA’s statement is they found no safety reason to set a lower recommended intake of BPA, don’t overlook what’s also embedded in the statement: This is EFSA’s third re-evaluation of the question in the last four years. And each time, they decided not to change their minds. There is significance in the fact that EFSA continually re-evaluates the same question of science. The secret could be that more than science is afoot.

As further evidence that disagreement remains among regulators, right after the EFSA decision was announced, officials in Denmark and France reaffirmed their preexisting bans on BPA. Denmark’s ban is on BPA in food contact materials for children up to age 3, and France bans its use in polycarbonate baby bottles. And in mid-October, Canada announced it was banning BPA as a “toxic substance.”

In the U.S., FDA’s most recent statement about the BPA came back in January. (See www.packworld.com/article-29126). FDA said the scientific evidence didn’t justify bans on its use, but that was tempered by FDA’s other statements that it would continue to study the safety of the substance, and supported industry efforts to find alternatives to BPA in can liners and stop using the substance in baby bottles.

That FDA set of mixed signals wasn’t even the only signpost about BPA regulatory attitudes within the U.S. The State of New York in August banned BPA in “child care products.” Meanwhile, Senator Diane Feinstein of California has suggested an amendment to the pending Food Safety Modernization Act in the Senate that would have the effect of banning BPA in baby bottles and infant formula containers. The suggested ban might hold up the whole food safety bill.

At Pira International’s Food Contact 2010 Conference in Washington, D.C. in late September, food contact experts from around the world, including some from industry, law and government, gathered to discuss a variety of issues. BPA was the elephant in that particular room, and it was a relevant coincidence that EFSA’s announcement emerged during the first day of the conference.

Dr. John Rost, who chairs the North American Metal Packaging Alliance, Inc., addressed BPA’s use in metal cans during the conference. He made a point that was echoed by multiple speakers during the rest of the two-day conference and associated workshop: That debates over the safety of materials are best guided by scientific considerations, but unfortunately, they often are not.

It is a fact of our modern marketplace that, once a consumer perception of a substance is created, it can be hard to shake, even with repeated reaffirmations from relevant scientists.

As a result, even if regulatory officials make decisions based only on science after careful and reasoned review by experts, their decision may only have the effect of avoiding a regulatory ban. If consumer acceptance does not also follow, a substance or material may still be considered unacceptable in the marketplace.

More than one speaker commented on the phenomenon that in the public mind, consumer product concerns about substances are driven by perceptions, or, even more unfortunately, misperceptions. By all means, revisit the scientific questions when the science warrants it, and take the actions indicated by the most solid conclusions reachable.

But to be guided by public opinion and outcry or even misperceptions is no way to run a modern society. PW

Eric can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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The Long Reach of FDA Accusations

The Long Reach of FDA Accusations

By Eric F. Greenberg, Attorney-at-law

The Long Reach of FDA Accusations

For those of you who think that regulators only pick on the small companies, have I got a story for you. And this story is also eye-opening if you have wondered who the government is most likely to go after when a problem arises, in a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market.

The short version of the story is that the Food and Drug Administration took action against Amazon for products sold on its website. Yes, that Amazon, the one with the big website where you can buy essentially everything for handy delivery. And this wasn’t the first time FDA has warned Amazon about products available on its popular website.

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