FDA Rejects Call to Ban BPA from Food Packaging

In a resounding defeat, health advocates and environmentalists in the United States lost the fight to take the chemical bisphenol-A out of food packaging. On March 30, the Food and Drug Administration rejected their petition to ban the industrial chemical from all food and drink packaging, including plastic bottles and canned food.

But the FDA stressed its latest ruling on the petition brought by the Natural Resources Defense Council (NRDC) wasn’t the final word. “The FDA denied the NRDC petition because it didn’t have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging,” FDA spokesman Doug Karas said a media statement.

“While evidence from some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact of BPA,” Karas told the Agence France Presse. But he also said, “I cannot stress enough that this is not a final safety determination on BPA.”

The NRDC petitioned the FDA in 2008 to ban BPA as a food additive — including all uses in food or beverage packaging. It was a routine petition, similar to those filed on various safety issues by advocacy groups, companies and individuals.

But when the FDA failed to respond within the timeframe required by law, the environmental group sued the agency. It pointed out that the FDA is legally mandated to respond to written petitions within 180 days. And in December, a federal judge ruled that the agency had to respond by the end of March.

Commonly used in food packaging, BPA has been found canned foods since the 1950s — and the practice is approved by the FDA. Because the chemical industry says BPA is the safest, most effective sealant, it’s so ubiquitous today that scientists have found it in the urine of 93 percent of Americans.

But it’s dangerous because it mimics the female hormone estrogen and is associated with health risks, including endocrine-related cancers.

‘No compelling scientific evidence’ — FDA

In seeking a ban on BPA in food packaging, food containers, and other materials likely to come into contact with food, the NRDC cited studies on animals that showed the hormone-disrupting chemical was linked to brain changes, chromosomal abnormalities and some cancers.

The NRDC has also cited some “emerging human research” that suggests a possible link between BPA exposure and cardiovascular disease, diabetes, miscarriage, erectile dysfunction and altered behavior in toddlers.

But the FDA told the Associated Press that the petitioners didn’t present compelling scientific evidence to justify new restrictions on the much-debated chemical. Still, it assured the public that federal scientists continue to study the issue. In its response, the FDA reiterated that:
• Findings in animal studies can’t be applied to humans.
• Some of the studies cited by NRDC were often too small to be conclusive.
• In some studies, researchers injecting BPA into animals, but in real life, people ingest the chemical through their diet over longer periods of time.
• Humans metabolize and eliminate BPA much more quickly than rats and other lab animals.

Responding in particular to studies that showed pregnant women exposed to BPA gave birth to infants with high BPA levels that affected their nervous systems and behavior, Karas told AFP that research done by the agency itself has shown that actual BPA exposure to human infants is 84-92 percent less than previously estimated.

“Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure,” Karas claimed.

Further animal studies done by the agency have also shown that BPA doesn’t pass easily from pregnant rodents to their offspring. BPA levels were “so low it could not be measured,” he claimed.

The FDA spokesman also said animal studies tend to be flawed because they often involve injections of BPA that boosts doses — when in fact, ingesting BPA orally through food results in the faster metabolism of the chemical to an inactive form.

Meanwhile, FDA officials also stress that their assessment of BPA is ongoing, and they expect to issue another update later this year based on their most recent findings.

The agency’s last official statement was that there’s “some concern” about BPA’s effects on infants and young children.

The U.S. government is also spending US$30 million to conduct even more studies on the chemical’s impact on humans. Several federal studies published in the last two years suggest that even human embryos retain far less BPA than other animals.

Long struggle over BPA
Human exposure to the industrial chemical was first assessed by the FDA in 1996, and it became a concern following evidence in lab animals of a toxic effect on the brain and nervous system.

Reacting to the FDA’s decision, environmentalists and public health advocates insist that the FDA is out of touch with reality. They cite the fact that health authorities in other countries across the world have declared BPA toxic and a growing number have banned it in some food packaging. Many more have banned its use specifically in the manufacture of baby bottles after studies showed that these bottles warmed in microwaves released BPA into infants’ milk.

A check by Health Care Zone shows that:
• Canada banned the chemical’s use in baby bottles since 2007.
• Canada then declared BPA a toxic substance in 2010.
• The European Union banned the use of BPA in the production of baby bottles since 2008.
• Turkey banned the use of BPA in baby bottles since 2008.
• Denmark banned the toxic chemical in all baby food product packaging.
• In Japan, the entire canning industry has since replaced its BPA resin can liners.

“Canada, the European Union, China, and at least five other countries as well as 11 U.S. states, all have prohibited the use of BPA in children’s products,” the NRDC said in a statement released to the media after the FDA made its decision.

While the FDA still allows BPA in baby bottles, several states have enacted state-level regulations against it: New York, Washington, Connecticut, Maryland, Minnesota, Vermont and Wisconsin. Colorado is also working on it, according to the World Health Organization.

And, in an act Forbes magazine hailed as a “gutsy move that put the health of Europeans ahead of big-business interests,” French lawmakers voted in February to ban the use of BPA in all food packaging.

The financial magazine also said it believes the new French law — set to take effect on Jan. 1, 2014 — will likely to lead to a EU-wide ban that would make it financially difficult for U.S. food manufacturers that sell into Europe to continue using BPA.

“We believe (the) FDA made the wrong call,” said Dr. Sarah Janssen, NRDC’s senior scientist for public health. “BPA is a toxic chemical that has no place in our food supply,” she said in a statement released to the media after the FDA decision was announced.

“The agency has failed to protect our health and safety — in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.”

“The FDA is out-of-step with scientific and medical research,” she also said. “This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”

But the FDA’s latest decision is only in line with the position it has maintained for a long time: that BPA doesn’t pose a health threat because it’s found in low levels in canned and packaged foods.

Many public health advocates have since argued that because canned goods are popular, the average person ends up consuming a total BPA load that is higher than the tolerance levels set for any single product.

Some scientists have argued that the plastic-hardening chemical has negative effects even at very low levels and the FDA’s average daily exposure estimates are really way off. According to independent studies conducted by Consumer Reports in 2009, “consumers eating just one serving of canned vegetable soup we tested would get about double what the FDA now considers typical average dietary daily exposure.”

Companies outpace the FDA

Interestingly, the FDA’s position is even less progressive than that of various industries that use BPA in their products or packaging. Responding to concerns raised over BPA use, many companies are moving quickly to take BPA out of their packaging and products. Even Wal-Mart Stores Inc. — not known for its being a health advocate — said way back in 2008 that it would remove BPA from its bottles, sippy cups and other children’s items. Toys “R” Us also made the same announcement. By the end of 2009, the six leading makers of baby bottles in the U.S. went BPA-free.

And at a shareholders meeting in February, Campbell’s Chief Financial Officer Craig Owens said his company had begun the shift to BPA-free cans — but he didn’t announce a specific timeline or any further details of its BPA-free commitment.

Cambell’s Soup was shown to have one of the highest BPA levels among a group of canned foods tested by the advocacy group Breast Cancer Fund last year. Particularly worrisome for American parents was the fact that the products that were most appealing to children — soups and Spaghetti-O’s with fun shapes in them — were also those that showed the highest BPA levels.

Some manufacturers have also begun switching to alternatives: ConAgra and General Mills say they have switched to alternative sealants for their canned tomato products and Heinz reportedly uses BPA-free coatings for its Nurture baby formula cans.

Still, producers of canned food have been wary of taking BPA out of linings in cans because the chemical effectively helps the can withstand high heat during sterilization, prevents corrosion and increases the shelf life of the food product. Available alternatives are either less effective, more expensive, or both.
So the vast majority of canned goods in the U.S. are still sealed with resin that contains BPA.

Aside from reproductive problems that are only expected since BPA mimics the female hormone estrogen, the chemical has also been linked by many studies to problems in fetal brain development, prostate and other cancers, as well as heart disease.

The evidence against the safety of BPA has been growing for more than four years.

A groundbreaking study by the Environmental Working Group in 2007 showed that BPA leached from epoxy linings of cans into surrounding food and drink. Canned soup, pasta and infant formula had the highest BPA concentrations, the EWG tests showed.

In a second study that year, the EWG also showed that one in 16 formula-fed babies were exposed to BPA levels that previous research showed was toxic to animals.

Because of these findings, the EWG has repeatedly called on the FDA to ban the use of BPA from food and beverage packaging — starting with infant formula.

In 2009, tests commissioned by EWG and Rachel’s Network detected, for the first time, BPA in the umbilical cord blood of nine out of 10 American newborns — highlighting the sheer prevalence of BPA in the environment and in people in the U.S.

In October 2011, a study from the Harvard School of Public Health published in the journal Pediatrics, found a link between exposure to BPA during pregnancy and hyperactivity, depression, anxiety and other behavioral problem in preschool-age girls. The study showed that the higher the mothers’ BPA levels, the worse their daughters rated on standard behavior tests and the more likely the girls were to exhibit behavior problems as toddlers.

Early this month (March 2012), British researchers found that people exposed to high levels of bisphenol-A have a slightly higher risk of heart disease.

It was the third study from the same team that found a link. Compared to people without heart disease, people with heart disease were more likely to also have higher levels of BPA in their urine, lead researcher Dr. David Melzer of the Peninsula Medical College in Exeter and his colleagues reported — first in 2008, then again in 2010, and then yet again in this 2012 research.

“We’ve now shown this association in two quite separate ways, in completely different people… and at very different exposure levels,” Dr. Melzer told Reuters Health.

But the researchers admit the link between BPA and heart disease was no longer statistically reliable after they accounted for factors like blood pressure, weight, exercise and social class. Still, the research shows that there’s some relationship between BPA and heart disease, Dr. Melzer says, suggesting that future studies should either add or subtract BPA from people’s diets to see how it affects their health.

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