BPA good news doesn’t end the story

March, 2015

Eric F. Greenberg | Attorney-at-Law

Publicity always trumps science, as I am fond of saying, so don’t get too excited that the Europeans have said current human exposure to Bisphenol A is safe. It’s not as if this is the first time anyone has said it’s safe. Fair’s fair, so safety studies will continue, but in the meantime, the experts are saying that current exposures are safe. The problem is, some people aren’t ever going to be convinced.

What the European Food Safety Authority said exactly is that “Exposure from the diet or from a combination of sources (diet, dust, cosmetics and thermal paper) is considerably under the safe level (the ‘tolerable daily intake’ or TDI).” Though they even reduced the level they consider safe to 4 micrograms per kilogram of body weight per day, they said the amount people are getting exposed to “from a combination of sources” is “three to five times lower than that.”

They worked from better data this time, they said, than they had available the last time they evaluated BPA’s safety, in 2006. One thing this new data told them was that a more accurate estimate of dietary exposure to BPA for all population groups puts the intake “four to fifteen times lower than previously estimated…, depending on the age group,” says Dr. Trine Husoy of EFSA. And they are still continuing to evaluate BPA’s safety, with an ongoing long-term study in rats.

BPA is used to make polycarbonate and is used in epoxy resins that are used to make linings to coat the insides of metal food and beverage cans. Questions have arisen about various health effects of the substance that have led to further studies as well as public concern apart from, and not necessarily guided by, the studies.

According to the North American Metal Packaging Alliance, which tracks BPA-related legal measures for its members, 13 states have banned BPA in some packaging products or in children’s products (such as baby bottles and sippy cups). Some county and municipal governments have also imposed similar bans, says the group. At least 20 countries plus those in the European Union have also imposed limits on BPA, most of the time in baby bottles but sometimes in other products as well. (With the emergence of the new EFSA conclusions, some are pushing France to repeal its BPA ban.)

The EFSA “CEF Panel” that deals with food contact materials did conclude that exposure to doses of BPA that are hundreds of times above the TDI “are likely to adversely affect the kidney and liver, and possibly also the mammary gland in animals.” But, they said, other effects were less certain based on available evidence. The CEF Panel also said the available data do not appear to show that there are “unexpected responses” to, for example, low doses of BPA.

As I am also fond of saying, if the Europeans think something’s safe, you can bet it’s probably safe. Philosophically guided by the “precautionary principle” and generally of a more regulatory bent than the U.S., European authorities are widely considered more conservative than their U.S. counterparts.

But even the U.S. Food and Drug Administration’s current safety assessment of BPA in food packaging is that “BPA is safe at the current levels occurring in foods”-that is, in the currently approved uses in food containers and packaging. BPA has been approved by FDA as a food additive for some uses since the 1960s.

FDA’s requirements provide for reexamination of the safety information about an additive when new information comes along, and FDA has been reexamining the question of BPA’s safety since at least 2008. In 2010, FDA concluded that “Although the reassessments indicated a need to further evaluate a number of endpoints or biological outcomes, the analyses did not recommend any adjustments to BPA levels reported in food at that time.”

They kept looking over the information, however, especially newly emerging studies “as they became available, including those addressing possible low-dose effects.”

In 2012, FDA took the rare step of repealing from its regulations the clearance of BPA for use in materials used to make baby bottles, sippy cups, and infant formula packaging based on petitions indicating that those uses “have been abandoned.”

The most recent culmination of FDA’s efforts was last fall’s completion of an examination of over 300 studies. The agency said, “The FDA review has not found any information in the evaluated studies to prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.”

And BPA is now on the radar screen over at the National Organics Program, of all things. Back in November, the USDA program asked its National Organic Standards Board to take a look at the use of BPA “and similar substances in the packaging of organic food,” presumably to check whether BPA might be considered a prohibited substance that compromises the organic integrity of organic foods. They asked their board to provide its recommendations on the use of these substances and to include consideration of BPA alternatives.

The scientific story of BPA, then, is still being written, and some chapters have certainly come out in favor of packaging. If only science were the whole story. PW

Eric Greenberg can be reached at [email protected]

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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