The Natural Resources Defense Council (NRDC) is suing the Food and Drug Administration with the hopes of forcing the agency to regulate bisphenol-A (BPA), a chemical commonly found in hard plastics (like reusable water and baby bottles), the lining of food and beverage containers, and other everyday products. Exposure to BPA has been linked to developmental disorder, cancer, heart diseases, and other health problems.

In October 2008, NRDC petitioned the FDA to set safety standards for bisphenol-A in food. “In light of the data suggesting that BPA is harmful to human health, and in response to the well-founded concerns of experts in the field, FDA must prohibit BPA from use in human food and food packaging, including in can linings and in beverage containers like baby bottles,” the petition says. Under the Federal Food, Drug, and Cosmetic Act, FDA had 90 days to grant the petition and begin a rulemaking, deny the petition, or ask for an extension of the 90-day time limit.

Instead, FDA did nothing. Nil, nada, squadoosh. So, on June 29, NRDC filed suit in the D.C. Circuit Court of Appeals asking the court to order FDA to respond to the petition.

“Our patience has run out,” NRDC scientist Sarah Jannsen wrote on the group’s website. “Most people assume that the government wouldn’t allow Americans to be exposed to BPA if it wasn’t safe, but while the FDA has been reviewing the science, as of yet, no action has been taken.”

Meanwhile, states continue to act in the absence of federal regulation. California’s state assembly moved the nation’s largest state one step closer to banning BPA in baby bottles and other products intended for infants and small children when it passed on July 1 the Toxics-Free Babies and Toddlers Act. The bill now moves to the state senate, where similar legislation has already passed.

“If passed, [the bill] would require the manufacturers of baby bottles, cups and jars to discontinue use of BPA by January 2012,” according to the Los Angeles Times. “Makers of infant formula would need to comply by July 2012.”

In January, FDA announced the results of a scientific evaluation of BPA and declared that it has “some concern” about the chemical’s health effects. However, the agency stopped short of outlining a regulatory path to limit consumer exposure to BPA.

On Friday, the Food and Drug Administration made its long-awaited announcement on the safety of bisphenol-A, a chemical ingredient in hard plastics, food can liners, and other common products. The verdict? “[R]ecent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure.”

While it’s good to hear FDA finally admit that BPA could be a health threat, its plan going forward lacks the aggressiveness many were expecting. Instead of announcing a regulatory path to limit consumer exposure to BPA, FDA reiterated warnings that parents throw away their children’s hard plastic baby bottles or cups if they are scratched and that that consumers avoid putting hot liquids in BPA containers.

Urvashi Rangan of Consumers Union hit the nail on the head when he called FDA’s message “confusing.” How can the agency say that something as seemingly-benign as a scratched bottle poses a potential threat, but not take precautionary steps? Food Safety News reports:

Dr. Rangan believes there is ample evidence for the government to regulate the chemical in food containers. "FDA's admission of concern with BPA is an encouraging change in its position and we hope it will lead to concrete protection for consumers. However, we are concerned that the new advice on reducing exposure puts the onus on consumers to protect themselves until such a ban is put in place." 

Consumers have lived too long under a cloud of uncertainty: while the federal government has sat on the sidelines, state and local governments have taken action, and manufacturers and retailers have taken BPA-laden products off store shelves.

At the same time, the Milwaukee Journal Sentinel has an interesting story that evokes some sympathy for the FDA. Apparently, officials at the agency feel hamstrung by their own regulatory framework:

FDA officials - including Sharfstein; Lynn Goldmann, a consultant to the FDA; and Jesse Goodman, the FDA's acting chief scientist - told the Journal Sentinel they were frustrated by the antiquated framework of the FDA's regulatory process.

Officials say they would like chemical manufacturers to report information about the chemical to them, including how much BPA they produce and where and how it is used.

But because BPA was classified years ago as an indirect food additive, it is not subject to the kind of scrutiny that other chemicals are. Without critical data about BPA, it is impossible to regulate the chemical, officials said. 

Sharfstein told the paper, "We may have to go after legislation to change it.”

The Food and Drug Administration (FDA) missed a self-imposed deadline to make a determination about the safety of bisphenol-A (BPA), a chemical ingredient in hard plastics, food can liners, and other common products. Studies have linked BPA exposure to heart disease, developmental disorders, and other health problems.

A draft assessment on BPA released by FDA last year was widely criticized. In the draft assessment, FDA identified "margins of safety" for both infants and adults and contended, at levels most humans are exposed to, the margins are adequate. But the FDA’s own scientific advisory board later said the available evidence "provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as 'adequate' are, in fact, inadequate."

In August, FDA said it would complete a review of the scientific information on BPA by the end of November. FDA now hopes to make a determination in the coming weeks. Meg Kissinger from the Milwaukee Journal Sentinel reports:

Michael Herndon, the FDA spokesman, urged patience.

"We are pushing hard for some decision soon," he said. "Too soon for anyone to be frustrated." 

However, with state and local governments taking regulatory action on BPA and some manufacturers limiting it in their products, consumers will continue to be frustrated until the federal government takes a definitive stance on BPA’s health effects.

Photo by Flickr user davidfntau. Used under a Creative Commons license.

Researchers spent years studying the effects of bisphenol-A (BPA) exposure on factory workers in China, and the news isn't good. The key findings of the study, which was funded by the U.S. National Institute of Occupational Safety and Health, are more or less summed up in these two passages:

• "After adjustment for potential confounders including age, education, marital status, current smoking status, a history of chronic diseases and
  exposure to other chemicals, and employment history, the BPA-exposed workers had a significantly higher risk of sexual dysfunction."
• "When employment in a BPA-exposed factory lasted 1 year or less, BPA-exposed workers already experienced a significantly higher frequency of reduced sexual function compared with unexposed workers during the same period of employment."

For more on the study, see this article from the Milwaukee Journal Sentinel.

BPA is an ingredient in hard, polycarbonate plastics. No. 7 plastics, like those used for reusable water bottles, are usually polycarbonate. Bisphenol-A is also an ingredient in certain resins used to line food cans.

Scads of studies have linked bisphenol-A exposure to heart disease, developmental disorders, and other health problems. But most of those studies used rodents to study the effects of BPA. The study of the Chinese workers is the first major study to look at human exposure.

BPA is ubiquitous, and as a result the exposure pathways are numerous. Environmental and occupational exposure in addition to food container and consumer product exposure put at least four federal regulatory agencies on the hook: the Environmental Protection Agency, Occupational Safety and Health Administration, Food and Drug Administration (FDA), and Consumer Product Safety Commission, respectively.

The study has this to say:

[T]he question of the adverse effect of exposure to BPA on human health has raised substantial concern among the public because of widespread presence of BPA in the environment and in consumer products such as baby bottles and food and water containers. Therefore, studies of the effect of BPA on humans are critically needed to help establish prevention strategies and regulatory policies.

The FDA has promised to update its opinion on BPA safety by the end of the month. Although we anxiously await that announcement, food and drink containers aren't the only means of BPA exposure. The Obama administration should begin, if it hasn't already, to contemplate a broader, inter-agency strategy to monitor and take action on BPA exposure.