Packaging Digest is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

FDA does about-face on exposure to BPA Agency says it will expand regulation but doesn't ban chemical

Article-FDA does about-face on exposure to BPA Agency says it will expand regulation but doesn't ban chemical



MEG KISSINGER, Staff, Milwaukee Journal Sentinel

The U.S. Food and Drug Administration on Friday reversed its much-criticized position on BPA safety, saying it was concerned about the chemical's effects on fetuses, infants and children.

The agency said it would work to reduce exposure to the chemical, which is found in the urine of 93% of Americans tested. But it stopped short of a ban, saying more studies are needed to better know the chemical's effects.

The agency also said it will move to expand its regulation of the chemical by trying to get manufacturers to report how much BPA they produce, where it is being made and how it is being used.

"We'd like a more nimble position to regulate this chemical," said FDA Commissioner Margaret Hamburg.

The agency's action, which was hailed by health and environmental groups, follows three years of investigative reports by the Journal Sentinel into the government's failure to limit the chemical's exposure, despite hundreds of studies that found BPA to cause harm.

In 2008, the FDA declared that BPA was safe for all uses based on two studies, both of which were paid for by the chemical industry.

The Journal Sentinel found that lobbyists for the chemical industry wrote entire sections of that decision.

The newspaper later obtained other e-mails that showed the FDA relied on chemical industry lobbyists to examine the chemical's risks, track legislation to ban it and even monitor news coverage.

More than 6 billion pounds of the chemical are manufactured each year, accounting for nearly $7 billion in sales.

The chemical is used to line nearly all food and beverage cans. It is used to make hard clear plastic for baby bottles, tableware, eyeglasses, dental sealants, DVDs and hundreds of other household objects.

BPA, which leaches into food and drink when it is heated, has been linked to prostate and breast cancer, reproductive failure, obesity, heart disease, diabetes and behavioral problems.

BPA manufacturers, however, have maintained it is safe - and they did so again Friday. Lobbyists for the chemical-makers have regularly pointed to the FDA's earlier ruling as proof for their stance.

The American Chemistry Council, the primary lobbying group for the industry, characterized the FDA's statement Friday as attempting to address "public confusion" on BPA, not valid safety concerns.

The group said it was "disappointed that some of the recommendations are likely to worry consumers and are not well-founded."

The chemical has been banned for use in baby bottles in Canada, Minnesota, Connecticut, the city of Chicago and two counties in New York. Similar bills are being considered in Wisconsin, Pennsylvania and Washington. A federal ban for all food contact items has been proposed in Congress.

Some seek more action

U.S. Rep. Edward Markey (D-Mass.), who introduced a federal bill to ban BPA from all food contact items, praised the FDA's move.

"It is clear that BPA poses serious health risks, and this finding is a major step toward eliminating exposure to this toxic substance," he said.

Environmental and health groups also praised the announcement, though some said it did not go far enough.

The Environmental Working Group, which has been working to ban BPA from baby bottles and the lining of infant formula cans, said Friday's announcement was a "Waterloo" for the chemical.

Others were more measured.

"This is a dramatic and overdue about-face for the FDA," said Diana Zuckerman, president of the National Research Center for Women & Families. "They have finally admitted concern. They are moving cautiously, which is appropriate because you don't want to substitute a new chemical that is equally dangerous. But it is essential that they not move too slowly.

"There is growing and disturbing research evidence that the health of children and adults is at stake."

Recent studies showed 90% of U.S. newborns tested had BPA present in umbilical cord blood and that Chinese factory workers exposed to huge amounts of the chemical experienced sexual dysfunction.

Groups including the Breast Cancer Fund and the Consumers Union said they were disappointed the FDA did not take stricter action.

Science, less politics

With its statement Friday, the FDA says it agrees with the National Toxicology Program that BPA poses some concern for its effects on the brain, behavior and prostate gland of fetuses, infants and children. That decision was released in 2008 and considered more than 700 studies.

Lynn Goldman, who was appointed by the Obama administration to serve as adviser to the FDA on the chemical, said Friday's announcement was an acknowledgment that the agency must focus more on the science of the chemical and not much on the politics.

In October, the Obama administration committed $30 million to studying BPA's effects. Those studies are being overseen by the National Institute of Environmental Health Sciences.

FDA is not recommending that families change the use of infant formula or foods.

But the agency urged consumers to follow the advice of the Department of Health and Human Services, saying the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.

"At this interim stage, FDA supports reasonable steps to reduce exposure of infants to BPA in the food supply," the agency said. "In addition, the FDA will work with industry to support and evaluate manufacturing practices and alternative substances that could reduce exposure to other populations."

In a conference call with the media Friday, Joshua Sharfstein, the FDA's principal deputy commissioner, added confusion to the announcement by saying that the FDA supported the use of BPA in baby bottles. Industry executives were quick to quote him.

But Sharfstein later called the newspaper to clarify.

"We do not support BPA in baby bottles," he said. "We support companies that remove BPA from baby bottles. I apologize for the confusion."

The agency announced steps to reduce BPA in the food supply and posted them on its Web site. They include:

* Supporting the industry's actions to stop producing BPA-containing baby bottles and infant feeding cups for the U.S. market;

* Facilitating the development of alternatives to BPA for the linings of infant formula cans; and

* Supporting efforts to replace BPA or minimize BPA levels in other food can linings.

Friday's statement came only after the FDA missed three self-imposed deadlines - notably one set for Nov. 30 - to issue a new determination on safety.

In December, Linda Birnbaum, the head of the primary federal agency studying the safety of BPA, told the Journal Sentinel that people should avoid ingesting the chemical, especially pregnant women, infants and children.

"There are plenty of reasonable alternatives," Birnbaum said.

She reiterated those comments Friday.

"This is why we are acting today," she said.

Read the full series To read the full Journal Sentinel "Chemical Fallout" series, which began in 2007, go to

Copyright 2010, Journal Sentinel Inc. All rights reserved. (Note: This notice does not apply to those news items already copyrighted and received through wire services or other media.)  

Copyright © 2010 LexisNexis, a division of Reed Elsevier Inc. All rights reserved.


Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Multigenerational Workforce

In today’s workplace, five generations are actively employed. In this free ebook, learn how to leverage the strengths of each generation in your packaging department.