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Public Outcry Forces FDA to Reverse Position on BPA

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In a stunning reversal of its former position, the FDA seeks more reliable tests and possible reclassification of BPA in the US.


According to the Mother Nature Network, a report recently released by the nonprofit Environmental Working Group (EWG) and Rachel's Network concluded a two-year study of toxins in the umbilical cord blood of 10 American babies of African-American, Asian, and Hispanic heritage born between 2007 and 2008.

EWG's director of communications, Alex Formuzis revealed disturbing information in the study, "Among 232 toxic chemicals found in the umbilical cord blood, bisphenol A (BPA), an estrogen-like chemical found in many products that's linked to early puberty, childhood obesity, breast cancer, neurological and behavioral changes," Formuzis said, "was found in nine of the 10 babies."

In addition to BPA, chemical substances "newly" discovered in the umbilical cord blood study include; a flame retardant designed for computer circuit boards, tetrabromobisphenol A, fragrance chemicals commonly used in cosmetics and detergents, galaxolide and tonalide and one of the Teflon chemicals that make non-stick, grease, stain and water-resistant coatings for everyday consumer kitchen products, perfluorobutanoic acid.

The study conclusion ended with this statement. "The chemicals found in these children are some of the most problematic compounds ever put into commerce. Their presence in fetal cord blood represents a significant failure on the part of the Congress and government agencies charged with protecting human health."

In an October 2009 article, the Science News described how, while working for the Polaroid Corporation, organic chemist John C. Warner learned about some of the carbonless copy papers used for credit card receipts as well as the thermal imaging papers that are printed by the majority of the cash registers. BPA usage is prevalent in both with manufacturers coating a powder layer of BPA onto one side of the receipt together with invisible ink. When BPA became controversial while Warner was teaching green chemistry at the University of Massachusetts, the chemist did some tests of his own. Warner sent students to local stores to gather cash register receipts. In the lab, they dissolved the paper and ran it through a mass spectrometer to look for a spike in the readout that signaled the presence of BPA. The amounts of BPA the cash receipts carried were serious.

"When people talk about polycarbonate bottles, they talk about nanogram quantities of BPA leaching out," Warner said in the article. "The average cash register receipt that's out there and uses the BPA technology will have 60 to 100milligrams of free BPA."

When it comes to BPA, Warner asserted in the article, "The biggest exposures, in my opinion, will be these cash register receipts."

Once on the fingers, BPA can be transferred, Warner explains, just like estrogen in birth-control formulations are delivered through the skin by controlled-release patches. Warner believes that BPA might similarly enter the skin. Warner has since become concerned enough to co-found the Warner Babcock Institute for Green Chemistry, which works within industry developing safer products and production processes.

Meanwhile, in the Fall 2009 Oxford Journal, a study was published examining the effect of occupational exposure to BPA on the risk of male sexual dysfunction. The study was conducted in China on factory workers by several well-known health groups including Kaiser Foundation Research Institute of Northern California, the Department of Environmental Health at the University of Washington, Seattle and the China Epidemiology Department of Shanghai, China.

Workers from BPA-exposed as well as control factories were recruited. Workers were exposed to very high BPA levels in their workplace. A relationship was observed with an increasing and cumulative level of BPA exposure associated with a higher risk of sexual dysfunction. When compared to the unexposed workers, BPA-exposed workers reported significantly higher frequencies of reduced sexual function within one year of employment in the BPA-exposed factories. Their conclusions categorically provide the first evidence that exposure to BPA in the workplace could have an adverse effect on male sexual dysfunction.

Consumer Reports Magazine reported in a December 2009 article about the dangers of BPA in tin cans, finding BPA in close to all of the 19 brand name products tested. The highest levels were found in Del Monte Green Beans, Progresso Vegetable Soup and Campbell's Condensed Chicken Noodle Soup. One serving of the canned vegetable soup contained almost double the dose of BPA that the FDA considers typical daily exposure.

These four studies were found during a brief internet search. In reality, there are over 200 independent studies confirming the health concerns surrounding BPA including 92% of 163 government-funded studies finding "significant negative effects" from low-level exposure to BPA. Based on these studies alone, the average person might consider ways in which to lower their risk to BPA but it won't be easy. In a November 2009, New York Times article, author Nicholas Kristof claims that the "US now produces the equivalent of six pounds of BPA per person per year." In a nutshell, BPA is everywhere.

Since its development in 1891, BPA has been used in a wide array of plastic products which now include CDs, DVDs, eyeglass lenses, sunglasses, bike helmets, dental sealants and bulletproof materials, in addition to being used in the epoxy resin that lines nearly all food and beverage cans. In the U.S., more than 2.3 billion tons of BPA is manufactured annually by Bayer Material Science, Dow Chemical Company, SABIC Innovative Plastics, formerly GE Plastics, Hexion Specialty Chemicals, and Sunoco Chemicals. BPA is inexpensive to produce, efficient and durable for businesses and manufacturers. However its hazards have been suspected at least since the 1930s when E. C. Dodds and Wilfrid Lawson conducted experiments on BPA's health effects on rats.

Currently, the daily upper limit of safe exposure is set at 50 micrograms of BPA per kilogram of body weight. That level is based on experiments done in the 1980s not the hundreds of more recent animal and laboratory studies including the studies above that indicate serious health risks could result from much lower doses of BPA.

BPA's ability to mimic and disrupt hormones is what makes it so dangerous. Hormones can stimulate some cancers. BPA is associated with both breast and prostate cancer. A known endocrine inhibitor, BPA can interfere with metabolism, sex organs, neurological and reproductive development. BPA has been linked to diabetes, obesity, heart and liver disease, early puberty, learning and behavioral problems. It has been found in more than 90 percent of human urine samples with babies considered to be at highest risk. Exposure in the womb to BP A and phthalates are two of the most likely causes of genital abnormalities which are now the most common birth defects in male American babies.

In June 2009, the FDA's new chief, Margaret Hamburg made a public promise that the agency would reconsider its earlier conclusion that BPA is safe. Some months later, the FDA's Science Advisory Board held a public hearing during which the board received testimony from many groups calling on the FDA to ban BPA from food and beverage containers. Although the evidence given to ban BPA was substantial, the FDA still refused to take a negative stand on BPA.

Studies the FDA sited for evidence were funded by industrial giant, the American Plastics Council. A subcommittee memo from Henry Waxman and Bart Stupak, chairmen of the Subcommittee on Oversight and Investigations to Hamburg in that same month is telling. Although the subcommittee acknowledged the FDA's "lack of consideration of the totality of exposures from other sources severely limit the usefulness of the safety assessment with respect to food contact applications." The best was saved for last, because after siting a Harvard study of water bottle drinkers and indicating that Bush's study was perhaps just too narrow, from the last paragraph of the memo; "We also request that FDA examine its processes to determine whether its interaction with and reliance on industry groups was appropriate in this case, and whether changes are needed going forward."

On the FDA website under BPA is their current statement on BPA: "At this time, the FDA is not recommending that anyone discontinue using products that contain BPA while we continue our risk assessment process. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles."
Under their overview of BPA, the FDA declared: "Based on our ongoing review, we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. However, we will continue to consider new research and information as they become available.

From the Organic Authority Files

This position was consistent with two risk assessments for BPA conducted by the European Food Safety Authority (EFSA) Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food and the Japanese National Institute of Advanced Industrial Science and Technology. Each of these documents considered the question of a possible low-dose effect and concluded that no current health risk exists for BPA at the current exposure levels."

Regarding the FDA's sources sited, both results were from EU and Japanese risk assessments; in 2009, a scientific study in the journal Regulatory toxicology and pharmacology was released which criticized the European risk assessment processes of endocrine disruptors, including BPA. One month later on December 22, 2009, the EU Environment ministers released a response statement expressing concerns over recent studies showing adverse effects of exposure to endocrine disrupters and calling for new studies and risk assessment.

Regarding the FDA's inclusion of Japan's risk assessment, over 10 years ago, Japanese manufacturers voluntarily undertook measures to reduce BPA in canned food and beverages. Most major Japanese manufacturers changed their can linings in 1997 to cut or eliminate the use of BPA because of concerns about health effects. On a positive note, a 2003 Japanese study found that the levels of the chemical in subjects' urine dropped by 50 percent after the change in cans was made.

So while the FDA's stance relied heavily on the Japanese' risk assessment, the Japanese evidently don't put much credence in it. Some U.S. manufacturers aren't willing to wait on the FDA to respond to growing consumer concern either. Playtex is phasing out BPA in its products, while Walmart and Toys-R-Us have issued statements announcing they will no longer sell products containing BPA. The grocery store chains Safeway and Whole foods recently announced they would no longer be stocking baby bottles manufactured with BPA.
Thus the public outcry on BPA does seem to be making some headway.

The Environmental Working Group took its findings, mentioned previously in this article, to a full Senate Environmental and Public Works Committee and Subcommittee on Superfund, Toxics and Environmental Health to demand tougher oversight and regulations. Among its recommendations, EWG wants the Centers for Disease Control and Prevention to "initiate a comprehensive cord blood-testing program," with the costs of the program borne by the industry that made these chemicals in the first place."

Then in October 2009, the National Institute of Health earmarked $30,000,000.00 in stimulus grants to conduct new studies on the health effects of BPA.

Now in the week since I began writing this article, the FDA acknowledged to the New York Times that we need to know more about BPA. In fact, the group has done a 360 on BPA, as reported in the New York Times article published last week on January 15. According to the article, "The agency said Friday that it had "some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children," and would join other federal health agencies in studying the chemical in both animals and humans."

In the Times article, the FDA's principal deputy commissioner Dr. Joshua Sharfstein said, "We are for the first time saying we believe there is some concern about the substance's safety, and we've closed the gap between N.I.H. and F.D.A.

Although going into details on Sharfstein's former BPA comments detracts from this positive move, suffice to say the good doctor had taken the opposite view of his current one in every interview and statement prior to this one.

Also, in response to questions regarding the validity of the FDA's prior testing methods and modes, Dr. Sharfstein said the drug agency had become more receptive to new techniques of studying the safety of chemicals.

The New York Times additionally quoted Dr. Sharfstein's statement that "the drug agency was also re-evaluating the way it regulates BPA. The substance is now classified as a food additive, a category that requires a cumbersome and time-consuming process to make regulatory changes. Dr. Sharfstein said he hoped its status could be changed to "food contact substance," which would give the F.D.A. more regulatory power and let it act more quickly if it needed to do so."

These statements are more than just an agency's backpedaling. These statements represent complete reversals of the FDA's positions on BPA. This is fantastic news for consumers.

However, the best advice for consumers at this point, in addition to knowing the facts, is still to reduce exposure to BPA. According to Scientific American magazine, BPA leaches out of plastic 55 times faster when heated so never microwave plastic or use it to store hot liquids or foods and never wash it in hot water. Dispose of scratched or worn bottles and cups made using BPA as BPA can leech from scratches and worn spots on bottles.

Buying fresh or frozen food, instead of canned products is also advised. When choosing plastic, the No. 7 recycling symbol is the main one to avoid for BPA. Items bearing the 3 and 6 symbols are also often listed as plastics to avoid since they contain phthalates. also believed to have hormone-disrupting abilities. Items with the 1, 2, 4 and 5 symbols are generally considered safe plastics.

Perhaps through consumer awareness and pressure, the FDA will actually revise their statement. For now, The Center for Health, Environment and Justice's Mike Schade is optimistic, "We know there are companies that want to do the right thing. Wal-Mart, Target, Babies R Us, Nalgene, CamelBak and others. They've been working to provide their customers with safe, BPA-free products, the products consumers want. The time has come for the food industry to follow suit."

With their stunning new reversal on their former BPA position statement, at least, the FDA is keeping its word to continue studying BPA. As consumers, avoiding BPA until we have all the answers is the best action we can take.

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