Lesson 7: If It S Harmful, Why Do We Use It?

What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? BPA and health On Friday, the U.S. Food and Drug Administration rejected a petition from the Natural Resources Defense Council asking for a ban on the chemical bisphenol-A, or BPA, saying that scientific studies cited in the group’s petition “failed to provide sufficient data … to revoke regulations permitting the use of BPA in food contact materials.” BPA is a chemical that mimics estrogen in the body. It is often used to make and line food containers and can leach into food and, subsequently, be ingested into the body. BPA is also present on many types of cash register receipts, where it rubs off onto people’s hands. Scientists are still working to ascertain exactly what effect BPA has on human health once ingested. They know that it is metabolized quickly and that it has been shown to have negative effects in mice, including developmental and reproductive abnormalities, precancerous changes in the prostate and breast, and other health problems. In epidemiological studies, researchers also have reported correlations between BPA levels in people and higher risk of ailments including cardiovascular disease, diabetes and liver problems. For consumer advocates, concerns like these are enough to justify banning BPA. But the findings don’t meet the scientific threshold that many regulatory bodies — including the FDA — require to remove the substance from use. Certain details of experiment design, as well as other factors, give regulators pause. In a letter written to the Natural Resources Defense Council, acting FDA associate commissioner for policy and planning David H. Dorsey explained that the agency looks for studies to satisfy several scientific principles. For example, the FDA wants studies’ dosing to reflect the amount of BPA a person might get through food and sample sizes to be large enough to provide confidence in results, he wrote. The studies cited by the council’s petition, he added, didn’t make the cut. One study cited was a review of previous studies written by urologists at the University of Illinois at Chicago in 2008. The paper argued that low-dose exposures to “environmental oestrogens” promoted prostate disease with aging. But the FDA noted that one of the experiments cited in the letter administered too high a dose of BPA to its rats to be relevant to human health. The FDA letter rejected another cited paper, published by Japanese biologists in 2008, because the research it described was conducted on bullfrog cells in a laboratory dish. Friday’s decision was not a final safety determination from the FDA, said spokesperson Douglas Karas, who added that the agency was working on a new, updated safety review that would “include all relevant studies and publications.” Linda S. Birnbaum, director of the National Institute of Environmental Health Sciences of the National Institutes of Health, said that her agency was funding experiments to directly address questions people are raising, including: How much of a problem is it? and At what level? “Our grantees have published nearly 100 papers since January 2010," she said. "Nothing has been published that says there isn’t any problem here. On the other hand, there are still a lot of outstanding questions." For instance, she said, “we want to have some surety that if BPA is removed from products, that what is put in its place is not a problem as well.”

Article from Brown, Eryn. (2012, March 30). BPA and Health: What the science does and doesn’t yet say. Los Angeles Times. Retrieved from http://articles.latimes.com/

1 What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? BPA in dental fillings The fillings and sealants that many dentists use can expose children to the controversial chemical bisphenol A (BPA), a new analysis indicates, but such exposure is short-lived and it remains unclear whether or not it poses a long-term health risk. Although these products do not contain pure BPA, saliva can cause the fillings and sealants to leach. This releases the chemical into the mouth and breaks it down to its pure form, the researchers explained. While the study authors do not recommend a ban of these dental products with pediatric patients, they caution parents and dentists to take steps that could minimize any potential risks associated with exposure to the ubiquitous chemical, which is found in many plastic products and has been linked to health issues such as male impotence, infant behavioral problems and birth defects. "The research that exists shows that upon contact with enzymes in the saliva some, but not all, BPA derivatives break down to pure BPA, and that BPA is said to be in saliva for a short time period of up to three hours," explained study author Dr. Abby F. Fleisch, a pediatrician in the department of medicine at Children's Hospital Boston, which is part of Harvard Medical School. "However, much of the risk that might be associated with this exposure is theoretical," she noted. "So, there's still a need for additional research looking at both systemic absorption -- as a result of this BPA exposure—into the blood and the urine, and whether there is a more chronic low-level leaching of BPA underway." Fleisch and her colleagues report their findings in the October issue of Pediatrics. Strong, easy-to-use and translucent, dental resins and sealant composites that contain BPA are a popular tool used to protect teeth from decay and to repair decayed, broken, or malformed teeth. According to the U.S. Food and Drug Administration, BPA has been used in the manufacturing of hard plastic bottles and metal cans since the 1960s. The agency notes that toxicity testing has indicated that human exposure to small amounts of the chemical is not problematic. However, some recent research with laboratory animals has linked BPA exposure to heart health issues, an increased risk for cancer and diabetes, and some degree of sexual dysfunction and hyperactivity. In addition, particular concerns have also been raised about the potential risk to the brain, prostate and behavioral health of young children, infants and fetuses. In light of that concern, the FDA in January took "reasonable steps to reduce human exposure to BPA in the food supply" by funding additional BPA research to the tune of $30 million. At the same time, the agency has been working with manufacturers to move away from products that contain the compound. Fleisch and her team noted, however, that the agency has not banned BPA from the market. The authors focused their analysis on the use of BPA-laced materials in dental products by reviewing what they characterized as "sparse" and "mixed" findings dating back about 15 years. Based on their review, they found there is exposure to pure BPA following dental procedures, but it appears to be short-lived. They added that some products contained different variations and concentrations of BPA. So, while noting that resin-based sealants are a critical tool for maintaining good oral health in children, the study authors called for manufacturers to label their sealant products to help dentists distinguish which formulations are more or less risky. The research team also stressed that steps should be taken to minimize exposure to children and pregnant women "to the greatest extent possible." "There are simple precautionary application techniques that can be used to dramatically reduce BPA exposure for people getting these sealants or white fillings," Fleisch noted. Gargling for about 30 seconds following application of a dental sealant will remove any excess BPA derivatives, she explained, and dentists can also clean off the sealant's surface once it has hardened.

2 What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? BPA expert Scott Belcher, an associate professor of pharmacology at the University of Cincinnati, said the research team's recommendation "is probably the most reasonable choice right now in terms of the tack to be taken." "Given all the things we don't understand right now about BPA's possible effects, these are common-sense conclusions and recommendations," he said. Article from Mozes, Alan. (2010, September 7). Fillings, sealants may leach BPA into kids’ mouths. US News Health. Retrieved from http://health.usnews.com/

3 What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? FDA Considers Banning BPA An unusual tactic embraced by one House lawmaker to keep bisphenol A out of food packaging met with limited success this month after federal regulators agreed to initiate a ban of the chemical in infant formula containers. In March, Rep. Edward J. Markey (D-Mass.) asked the Food and Drug Administration to ban the chemical’s use in the formula containers. In two other petitions, Markey also asked the agency to stop the use of BPA in small reusable food containers as well as in packaging for canned foods and beverages — requests the agency rejected this month. BPA has been used for more than four decades to harden plastics. It is also used in the protective linings of metal food and beverage cans. For years, consumer advocates have pushed to eliminate the chemical from food packaging, citing potential health risks should BPA leach into food at dangerous levels. But Markey took a different tack. He used a provision that allows people to petition for changes to food additive rules if they can demonstrate that a particular use of the additive has been abandoned. His office polled the industry to determine BPA’s prevalence in packaging. Using the “abandonment” clause enables the government to sidestep the debate over BPA’s safety and still eliminate its use. While Markey argued that major manufacturers no longer use the chemical, his goal was to make sure that they never can. The FDA accepted the petition on infant formula, suggesting that it is seriously considering it. It plans to collect comment from the public before making a final decision. In a letter to Markey this month, the FDA said it would try to complete a scientific review of his request within 90 days. “New parents should be worried about bibs and bottles, not BPA when feeding their babies,” Markey said in a statement Tuesday. But the FDA said the evidence presented on canned foods and beverages as well as small reusable containers failed to demonstrate that a significant percentage of the industry has abandoned BPA in those packages. “You did not provide a rationale [on] how these manufacturers were identified and whether they represent a complete survey of all manufacturers,” the agency said. The government has long maintained that BPA is safe in low doses. But a growing body of research suggests that exposure to this chemical could contribute to cancer, sexual dysfunction, behavioral problems in children and heart disease. The government started studying the issue more closely two years ago as new research emerged about the subtle effects of low doses of BPA in laboratory animals. The American Chemistry Council, which represents the chemical industry, has said that several regulatory bodies worldwide have determined that BPA is safe. But consumer preferences forced manufacturers to abandon its use in several products, including baby bottles and sippy cups. Even so, many health advocates have been pressing the government to adopt a formal ban. The Natural Resources Defense Council sued the FDA after the agency failed to respond to its 2008 request to bar the chemical from use in food and drink containers. In March, after a federal judge demanded that the FDA respond, the agency said it would allow BPA to remain in those types of packages.

Article from ElBoghdady, Dina. (2012, June 12). FDA considers banning BPA in infant formula containers in response to lawmaker’s stratagem. The Washington Post. Retrieved from http://www.washingtonpost.com/

4 What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? BPA in canned foods An advocacy group committed to exposing and eliminating environmental risks for breast cancer has taken aim at canned foods popular among kids, reheating the debate on bisphenol A. A new report from the Breast Cancer Fund reveals 12 canned soups and pastas found to contain BPA -- an estrogen-like chemical raising concern among experts for its potential health effects in children, infants and fetuses. Topping the list was Campbell's Disney Princess Cool Shapes with 148 parts per billion. The average level across all 12 cans was 49 parts per billion. "The findings of this report outline the urgent need to remove BPA from food packaging -- a major source of exposure to this toxic hormone disruptor -- especially in foods marketed to children," the report states. BPA, a key ingredient in hard plastics and resins used to coat metal cans, made headlines in 2008 when it was shown to leach out of plastic when heated. The Canadian government responded by banning the chemical from baby bottles. In the United States, the federal government has not followed suit, but several local governments have and leading U.S. baby bottle manufacturers went BPA-free voluntarily. But the chemical continues to line the country's cans. "I think they're definitely right in trying to get this chemical out of canned foods," said Dr. John Spangler, professor of family and community medicine at Wake Forest School of Medicine. "We can't do anything about past exposures but we can do something about current exposures." When it comes to the health effects of BPA, the jury's still out, according to the World Health Organization. Laboratory studies in cells and animals have linked the chemical to cancer, infertility, diabetes and obesity. But the consequences of chronic exposure in humans remain unclear. Nevertheless, many experts and parents err on the side of caution. "There are things we can do to minimize our exposure to BPA," Spangler said. "We can use fresh or dried pasta and sauce in jars. We can eat more fresh fruits and vegetables and fewer canned foods." Spangler said he hopes the Breast Cancer Fund report persuades canned food manufacturers to look for alternatives to BPA. But Campbell Soup Company spokesman Anthony Sanzio said the company is confident in the safety of its products. "The overwhelming weight of scientific evidence shows that the use of BPA in can lining poses no threat to human health," he said. "That being said, we understand that consumers may have concerns about it. We're very aware of the debate and we're watching it intently." In 2009 the National Institute of Environmental Health Sciences allotted $30 million in funding to study the health effects of BPA -- a splurge expected to yield results next fall. In the meantime, the Food and Drug Administration is "facilitating the development of alternatives to BPA," according to its website. A spokesman for the FDA did not respond to ABC News requests for a comment on the Breast Cancer Fund report or the status of BPA research. In a campaign called "Cans Not Cancer," the Breast Cancer Fund urges canned food manufacturers to substitute BPA with something safer -- a feat Campbell's Sanzio said is easier said than done. "I think statements such as this, that there all alternatives and companies can just flip a switch, it's just not accurate," said Sanzio. "At this point the industry has not identified a reliable alternative to BPA for large scale production." Though the FDA has opted to wait for more evidence before taking action on BPA, several states including Connecticut and Minnesota have enacted their own laws banning the sale of baby bottles, sippy cups and other reusable food and drink containers that contain it. And Pennsylvania might be next. Rep. Lawrence Curry is holding a public hearing today on BPA in baby products. Rebecca Roberts, a scientist and mother of three, is testifying in support of a ban.

5 What changes our minds? Toxicants, exposure, and the environment August 2012 Lesson 7: If it’s harmful, why do we use it? "BPA needs to be regulated so that those products are no longer used in this country," said Roberts, an assistant professor of biology at Ursinus College in Collegeville, Pa. "There are alternatives; we just need to do it." In 2007, Roberts published a first-person editorial in PLoS Biology on her experience with BPA as a scientist and a mother. "The mother in me still waits anxiously for the regulatory agencies and the legislature to catch up with the research on BPA that the scientist in me appreciates," Roberts wrote. "I have switched my brand of sippy cups to one that doesn't contain BPA (a quick Internet search will yield many sites describing these and other BPA-free baby products). "Nevertheless, while I feel proactive as I watch my daughter happily drink her water, I still cringe a little bit when she drops the sippy cup, toddles over to her toy bin, and starts to gnaw on her plastic turtle instead." Article from Moisse, Katie. (2011, September 21). BPA in canned foods: Should you worry? ABC News. Retrieved from http://abcnews.go.com/