Dear Madam Commissioner,

The Food and Drug Administration (FDA) has yet to issue its final decision on whether bisphenol A (BPA), an industrial chemical and synthetic estrogen, should be used in food packaging. As even the chemical industry has acknowledged, BPA leaches into foods and beverages from polycarbonate plastic containers and epoxy-based metal food can linings.

As authoritative studies by U.S. Centers for Disease Control and Prevention (CDC) have demonstrated, nearly all Americans test positive for traces of BPA. Environmental Working Group’s most recent study of cord blood found BPA in 9 of 10 samples taken from children born in 2007 and 2008.

Dozens of animal studies suggest that very low doses of BPA disrupt the endocrine system, undermine normal neurological and reproductive development and trigger a variety of chronic and serious disorders such as cancer, diminished brain function and intellectual capacity, asthma, obesity and diabetes.

Important new research demonstrates that BPA harms not only laboratory animals but also humans. It is significant and troubling that physical changes are being detected even at the very low levels to which people are routinely exposed because of BPA contamination in food and other products.

A British study published January 13 adds to this growing body of science by reporting that Americans with high concentrations of BPA in their urine were more likely to report having heart disease or diabetes than people with lower BPA measurements.

Tens of millions of children undergoing crucial windows of development are being exposed daily to this dangerous chemical via plastic baby bottles and sippy cups, canned infant formula and popular foods such as canned soup. Ubiquitous BPA contamination of our food is believed to have a subtle but lasting impact on Americans’ health.

We cannot quantify the cost to our society, in terms of medical bills, lost productivity and troubled lives. But we are sure of this: the price, whatever it is, is too high, and it is unnecessary.

Other federal agencies have singled out BPA as a major focus of research and potential regulation. In December, the National Institutes for Environmental Health Sciences (NIEHS) launched a $14 million research initiative in hopes of determining the human health risk of BPA. The Environmental Protection Agency (EPA) has identified BPA as a possible human health threat and priority for risk assessment.

Yet the FDA has remained silent. How much more does the FDA need to know to be convinced it must protect the national food supply from further contamination? We urge you to act now to prohibit the use of BPA in food and food containers.

Thank you for your attention.

Sincerely,

Kenneth Cook
President, Environmental Working Group

Copies: The Honorable Lisa Jackson, Administrator, U.S. EPA
Dr. Linda Birnbaum, Director, NIEHS

On January 22, the FDA announced they would support a shift in the food industry away from packaging that uses BPA.  Additionally, the FDA would support changes in the regulatory framework for oversight of BPA.

Other great news is that Linda Birnbaum, director of the NIEHS (National Institute of Environmental Health Services), has devoted $14 million from the Obama emergency stimulus package to investigate BPA and human health.  Lisa Jackson, EPA administrator, has also ordered a fast-track risk assesment of BPA and five other high-profile chemicals.  It looks as if the EPA is planning to step-up regulation on these chemicals.

Happy 2010!!!

For more, see the Kid Safe Chemical Act blog post on this.

• Atrazine — most commonly sprayed agricultural pesticide/herbicide, commonly found in ground and stream water.
• Phthalates — a group of chemicals that make plastics like PVC flexible, also found in personal care products, detergents, soaps, food packaging, building materials, inflatable toys, and medical equipment like IV tubing.
• Polybrominated diphenyl ethers (PBDEs) — a family of flame retardants used since the 1970s that are chemically very similar to the now banned PCBs, found in upholstered furniture, mattresses, carpet padding, vehicle upholstery, and electronics.
• Bisphenol A (BPA) — a chemical building block for polycarbonate plastic and epoxy resins, found in canned foods, food and beverage containers, PC (usually #7 plastic), and even some dental sealants/composites.
• Perflourinated chemicals — chemicals that resist water, grease, and stains, found in products with names like Teflon, Scotchgard, Stainmaster, and GORE-TEX, and also found in nonstick cookware, stain resistance clothing/shoes/furniture, waterproof outerwear, some dental floss, microwave popcorn bags, and fast-food packaging.

I love how Nena Baker dives deeply into a handful of the most toxic chemicals and really gives her readers the low-down on how long the chemical has been around, where it is found, its half-life, what researchers have found out about its effect on humans and the environment, the politics surrounding it, etc.  Her focus is one I’ve not seen before in other similar books–she clearly thinks policy change is in order.  The Toxic Substances Control Act (TSCA) of 1976 is horribly ineffective and Baker shows us how strikingly different the EU’s REACH policy is.  While I want to know what I can do now to reduce my family’s exposure to these substances, Baker convincingly argues that what’s really needed is new legislation to regulate the chemicals that are widely produced.  More than 30 years after the TCSA was enacted, the EPA has used its authority to test fewer than 200 of the 62,000 chemicals grandfathered in by the TCSA and presumed safe.  The TCSA is toothless.  She does include a brief section in the appendix about what to do to reduce exposure, but this is not the focus of her book.

I know that many of you are interested in the book, but do not have the time or will to read the whole thing.  So as usual, I’m including some of my favorite excerpts and facts so that you can get a taste of what the book covers:

• Number of full-time FDA positions in 1980: 978.  Number in 2008: 400.
• Existing chemicals are considered safe until proven guilty.
• The EPA cannot take any regulatory action regarding a suspected harmful substance until it has evidence that is poses an “unreasonable” risk of injury to human health or the environment.  The barriers to action are so high that, according to a 2005 report by the Government Accountability Office, the EPA has given up trying to regulate chemicals and instead relies on the chemical industry to act voluntarily when concerns arise.
• Since the implementation of TSCA, the EPA has attempted outright bans on only two chemicals.  The EPA has not attempted to ban a toxic chemical is 1989.
• The TSCA gave blanket approval to 62,000 chemicals in commerce prior to the legislation’s implementation in 1976.  No questions were asked.  No hazard data was required.  Therefore, 99% (by volume) of chemicals used today are older substances that were grandfathered in under the toxics act.  Chemical manufacturers are responsible for reporting any potential problems they discover about these products.  This makes EPA chemical risk management dependent on information volunteered by industry, and industry has little incentive to look for damning problems or to disclose all it knows.
• Dr. Lynn Goldman, a pediatrician and professor, and an assistant administrator of the EPA’s Office of Prevention, Pesticides and Toxic Substances from 1993 to 1998 has said:  “As soon as chemical manufacturers identify a new problem with a chemical, then that chemical becomes vulnerable to regulation.  And so if you were sitting there worried about protecting shareholder value, would the first thing on your mind be to go out and find more problems with your product that will then be subject to more regulation?  It would not, because the more regulations, the less likely your customers are to want to purchase the chemical from you.  And so in the way the laws are structured, there’s a perverse incentive not to look.  The financial incentive is that as long as you don’t look, if you have no data about hazards, no data about exposures, then there is no risk assessment and then there is no risk, which is, of course, not actually true.  But that is, in effect, how it works.”
• It’s not that chemicals are bad per se…. it’s that costly societal problems often arise because we know so little about so many chemicals.  And in the time it takes to learn what harm a substance is doing–to people, to animals, to places–the genie is long out of the bottle.  (Examples:  DDT, PCBs).
• Margot Wallstrom, European Commission vice president, has said “We need to shift the responsibility for chemical safety to the chemicals industry itself.  Taking responsibility for your own products is standard practice everywhere…  Why should the chemicals industry industry be treated in a different way?”
• The EU has passed a policy, known as REACH (Registration, Evaluation, Authorization, and Restriction of Chemical Substances) which will require manufacturers to produce risk and exposure information on about 30,000 chemicals.  REACH promises to close the knowledge gap on chemicals, reverse the burden of proof so that manufacturers must demonstrate a product is safe before it gets to market, and make more information available to consumers.
• About 10,500 ingredients are used in the product category of cosmetics…. yet the FDA has banned or restricted only 9 ingredients in the seven decades it has monitored cosmetics safety.  By contrast, the European Union explicitly prohibits the use of more than 1000 ingredients in beauty-care products.
• In 2008, the Washington Toxics Coalition released a report showing that playthings the group purchased from Toys “R” Us, Walmart, and Target contained phthalates at levels ranging from 28% to 47.5%.
• At least five different phthalates are present in cosmetics and personal-care products, according to the FDA, and scores of products that do not list phthalates as a separate ingredient contain them anyway.  That’s because fragrance formulations, which are heavily dependent on phthalates, are listed simply as “fragrance” on ingredient labels.  And any ingredient claimed as a trade secret is also exempt from labeling.
• Research by the University of Washington, published in Pediatrics in February of 2008, found that infants under the age of eight months, who are the most vulnerable to potential adverse effects because of their still-developing endocrine and reproductive systems, are the most highly exposed to phthalates.
• Polybrominated diphynyl ethers (PBDEs) act as flame retardants when blended into products like car trim, carpet pads, mattresses and televisions.  High heat or flames trigger these PBDEs to release bromines that rob the air of the oxygen that fires need to stay alive.
• In the three decades since manufactureres began adding PBDEs to plastics and foam, these chemicals have contimanted people, animals, and places all over the world.
• Levels of PBDEs in human fat, blood, and breast milke in North America–the largest user of these flame retardants–are 10-100 times higher than those reported for Europe and Asia.  Levels are continuing to increase.  “We have now seen PBDE concentrations in some people higher than where we have seen effects in experimental animals,” said Linda Birnbaum, director of the EPA’s Experimental Toxicology Division.
• Infants receive the largest exposure to PBDEs through breast milk, but toddlers, children, teens, and adults get their biggest doses of PBDEs through inadverant ingestion of house dust.  A 2004 study anazlyed floor dust and dryer lint and found PBDEs in every sample at concentrations ranging from 700 to 30,100 nanograms per gram.
• Swedish researchers discovered by accideant that PBDE levels were increasing in breast milk by a jaw-dropping sixty-fold increase between 1972 and 1997 (with concentrations doubling every five years).  In 1999, the government submitted a proposal to prohibit the use of PBDEs.  Immediately after Sweden discontinued using PBDEs, total levels in breast milk began falling, dropping 30% between 1997 and 2000.
• Canadian researchers found PBDE levels in breast milk were doubling every 2.6 years, compared to five years in Sweden.  In the U.S., a 2003 study of nursing mothers in Texas, found that levels of flame retardants in breast milk were as much as 100 times higher than levels seen in Europe.
• Penta and Octa PBDEs are no longer produced (the company disconinued the two substances in 2005 after the EU and California instituted bans), but Deca is.  At first, Deca was not suspected of building up in human tissues as it was thought that the larger molecules were to stable to be a toxic threat.  But PBDE exposures are rising so rapidly that researchers began to wonder if Deca was somehow contributing to the problem.  Now, a growing stack of scientific studies suggests that Deca can break down, or degrade, into more toxic and bioaccumulative forms of PBDEs like the ones no longer in production.  About 80% of all Deca is used in housings for televisions sets and computers.
• Penta and Octa are in products that people keep around for a long time (sofas, mixers, TVs, cars).  Penta can account for as much as 30% of a product by wieght and Octa by as much as 18%.  And because of the way they were blended in during the manufacturing process, they leach our during a product’s entire life cycle–from manufacturing, through the years spent in a home or car, and finally, when the poor old thing is put to rest in a landfill or incincerated.
• Companies like Dell, IKEA, Apple, Sony, and Hewlett-Packard have for years demonstrated their ability to meet fire safety standards without the use of Deca.  However, the move away from Deca hasn’t been quite as thorought for televisions (exceptions include Sony and Panasonic).
• 95% of humans have blood levels of bisphenol A (BPA) within a range that is predicted to be biologically active, based on animal studies conducted with low doses of the chemical.  There is essentially no difference in the way that mouse and rats cells respond to BPA and the way human cells respond to it.  The adverse effects include breast and prostate cancer, increases in urogenital abnormalities  in male babies, a decline in semen quality in men, early onset of puberty in girls, metabolic disorders including Type 2 diabetes and obesity, and ADHD.
• Since 1997, industry has sponsed 13 large-scale studies on low-does effects of BPA.  None found problems.  By comparison, out of 163 low-dose studies funded by government and principally carried out at universities, 93% found evidence of harm.
• BPA does not produce a linear dose-response curve (with higher doses causing more harm than lower doses).  Instead, BPA, like other endocrine-disrupting compounds, produces a strange appearing dose-response curve, shaped much like an inverted U.  This curve shows that medium doses of BPA–though still trace amounts–produce effects not predicted by the toxicology models relied on by regulators.
• There are studies of BPA that show effects in animals at 200 times below the levels found in humans.
• Even paper towels and food take-out containers contain BPA.  Studies show recycled paper product contains higher levels of BPA than that made with virgin material because of how the chemical is used in paper production.
• Research at Washington State University discovered that exposure to BPA while pregnant can affect future grandchildren.  Because females form their eggs with still in their mother’s womb, not only is the fetus exposed to BPA but also the eggs that will produce the next generation.  And eggs exposed to BPA in utero are found to have greater chromosomal abnormalities–ones that are the leading causes of miscarriage, congenital defets, and mental retardation in humans.
• The fetus is protected from the high levels of estrogen in the mother during pregnancy with the help of a sex-hormone-binding globulin.  This globulin blocks natural estrogen from entering cells.  However, the great majority of man-made estrogen-mimicing chemicals are not inhibited from entering cells.  They go right past this barrier system, and the receptor in the cell that causes changes when estrogen binds to it is, unfortunately, very responsive to BPA.
• Effects of BPA have been noted at levels as small as 2 parts per billion.
• A 2008 study found that low levels of BPA caused normal, noncancerous human breast cells to express genes characteristic of aggressive breast cancer cells.
• For decades, scientists and regulators assumed perflourinated chemicals were not toxic and, because they were incorporated into polymers, biologically inert.  This was incorrect.  Instead, the substances represent a new type of persistent organic pollutant that, well, redefines persistence.  PFOA, PFOS, and closely related substances are virtually indestructible.  They owe their muscle to a carbon-flourine bond that is among the strongest in organic chemistry.  A chemistry professor at the University of Toronto who is one of the world’s leading researchers on these chemicals, Scott Mabury, said “You take DDT, the thing that Rachel Carson was concerned about, and PFOA makes it look ephemeral.  DDT has a half-life in soil of ten years.  Put these in soil and you will never see them degrade under any conditions.  You simply can’t predict what the half-life would be.”
• Unlike most persistant organic pollutants, perflourinated chemicals bind to blood proteins and blood-rich areas such as the liver.  Traditional risk assessment models are not sufficient in characterizing these chemicals, which makes the work of EPA scientists very slow going.  To understand the properties, sources, and pathways of exposure requires new research that can take years to complete.
• Companies that use PFOA in their products include Rug Doctor, Stanley Steamer, McDonald’s, Taco Bell, Papa John’s, Pizza Hut, KFC, California Pizza Kitchen, Levi Strauss, ConAgra Foods, Gap, Eddie Bauer, J. Crew, W.L. Gore & Associates, Walmart, Sears, Norstrom, and Dillard’s.
• The biological half-life for PFOA is 3.8 years.  For PFOS, it’s 5.4 years.  98% of the population has perflourinated chemicals in their blood, averaging 5 parts per billion per kg of body weight.

Sites worth visiting:

• Kid Safe Chemicals
• Campaign for Safe Cosmetics
• Making Our Milk Safe (MOMS)

One of those books that I recently read is The Toxic Sandbox (2007).  It is a quick read at only 175 pages.  The format of the book is ideal for parents–highly organized with subject matter separated into chapters and sections and often easily ID’d by bold questions.  The book is also based on solid research and written by a mom who has personal experience with toxins affecting her child (in her case, lead).  You can skip to exactly what interests you and get the basic information you need to know about the dangers and how to protect your children.  This book could easily be read or skimmed by a busy parent in a day or two.

The author, Libby McDonald, covers six toxins in six chapters:  lead, mercury, plastics (including BPA and phthalates), PCBs and flame retardants (PBDE’s), air pollution, and pesticides.  I found the PCB/PBDE chapter especially interesting, as it’s something I’m not as familiar with.  Here are some of my favorite excerpts and facts from the book:

• Lead is so dangerous because it masquerades as calcium, allowing it to cross the blood brain barrier.  Because babies’ and toddlers’ brains crave calcium in their effort to develop, until children are around six years old they can absorb three to four times more lead than an adult.
• Rats exposed to phthalates in EPA studies have contracted liver cancer and developed damaged kidneys.  In addition, male rat pups exposed to the chemical in utero experience dramatic reproductive mutation, including smaller scrotums, undescended testicles, hypospadias (urethra opening is not on tip of penis), and reduced penis size.  This cluster of abnormalities frequently results in lower sperm counts, infertility, reduced testosterone, and testicular cancer.
• The three most potent phthalates (there are 8 total) are diethyl phthalate (DEHP), dibutyl phthalate (DBP–found in nail polish, cosmetics, and insecticides), and benzylbutyl phthalates (BBP–found in adhesives, paints, sealants, car-care products, vinyl flooring, and some personal care products).  Not only do they adversely affect healthy by themselves, but even in small doses they interact with one another in ways we don’t understand.  The dominant phthalate, DEHP (found in shower curtains, cable sheathing, garden hoses, medical devices, vinyl products, floor tiles, rain-wear, some food containers, and some toys), has been used so widely that it can now be found literally all over the world: in subsurface snow in Antarctica and in jellyfish more than 300 feet below the surface of the Atlantic.
• Although the EPA banned the production of polychlorinated biphenyls (PCBs) in 1977, they persist in the environment and in our food chain.  They are not only persistent but also fat soluble, which means they can linger for decades in the fatty tissue of virtually every living organism on the planet.
• Because PCBs accumulate in our bodies more quickly than they are excreted, the older we are when we have children, the more PCBs we expose are babies to.  Part of this is through breastfeeding, as PCB levels in breast milk are found to decrease as we nurse our babies (meaning we are passing the PCBs onto our children).
• Flame retardants, PBDEs, are structurally and toxicologically like their chemical-cousin PCBs.  They are also persistent and bioaccumulative.  Scientists believe they harm children much as PCBs do, by affecting learning, memory, attention, and behavior.
• PBDE concentrations in North American women’s breast milk has been measured at 75 times higher than levels in the breast milk of European women.
• In animal studies, PCBs and PBDEs are linked to low birth weight, decreased intelligence, problems with short-term memory, attention deficit disorders, impaired immune function, hypothyroidism, various cancers, and disruption of sex hormones.
• Ninety percent of a child’s PCB intake is through food (especially fish).  You can greatly reduce the amount of PCBs and PBDEs your children consumer by serving low or fat free dairy products, low fat meats, or by avoiding animal products all together.  Avoid farmed salmon and fish.  Wild Pacific slamon have much less PCBs than farmed, because they eat lower on the food chain and are more active so they have less fat that stores PCBs.
• The Swedes were the first to detect PBDE in mothers’ breast milk by analyzing stored suplies from 1972 to 1997.  They found that PBDEs were doubling in breast milk every five years and banned some PBDEs in 2003.  Since then, PBDE levels in Swedish mothers’ breast milk have decreased significantly.   US levels are far higher than those that warranted banning the use of PBDEs in products in Sweden.
• PBDE levels in breast milk in 2002 found that they were 10-100 times higher in the U.S. than in Europe.  Median blood levels in the US population show an exposure of PBDEs similar to that of Swedish laboreres who actually worked in factories that manufactured PBDE-treated rubber.
• The half life of PCBs and PBDEs (also known as persistent organic pollutants or POPs)  in your body is ten years!
• Levels of PBDEs are 2-15 times higher for children than adults.  The levels found in children are uncomforatably close to those associated with advers effects on reproduction and neurodevelopment in laboratory animals.  Children may be exposed to more PBDEs through household dust that contains PBDEs (the EPA estimates that children from age 1-4 ingest 100 mg of household dust each day compared to 15 mg for adults).  Babies also get PBDEs from breast milk.
• Grass-fed animals have fewer PCBs and PBDEs than factory farm-raised animals.
• From 1980 to 2003, the prevelance of asthma in American children rose from 3.6% to 5.8%, or about a 60% increase.
• Children riding to and from school in school buses manufactured between 1985 and 2002 inhaled 34-79% more air pollution than the average weekday commuter did on the same day.
• The EPA estimates that about 80% of our total pesticide exposure comes through the food we eat.  The remaining 20% comes from drinking water and pesticide use in the home to control insects and rodents.
• Americans have more perflourochemicals (PFCs–chemicals used in nonstick cookware, clothing stain repellents, fast-food wrappers) than any other population on earth.  PFCs remain in our bodies and in the environment for a years.

The author maintains a nice website with additional information about toxins in our environment.

Also see:

• http://www.ewg.org/sites/humantoxome/
• http://www.ewg.org/reports/bodyburden2/execsumm.php
• http://healthtakenseriously.com/2008/09/08/new-research-shows-bpa-damages-monkey-brain-synapses/
• http://healthtakenseriously.com/2008/05/08/the-latest-in-the-world-of-bpa/

This was their response:

More than three years later, I am now learning that SIGG’s aluminum water bottles do in fact contain BPA in the lining.  The company asserts that tests show that no BPA leaches from that lining.  I personally don’t care what their tests show.  I bought that water bottle in an attempt to avoid plastics, whether or not their maker believes they leach into the liquids they contain.  Please see the Zrecs summary of the story.

Now….. what to do with my five SIGG water bottles?

For those of you not up to speed on BPA, here’s a quick recap.  In the U.S., 7 billion pounds of BPA are produced annually.  Since 2004, we have known that detectable levels of BPA are found in the blood of 93% of Americans over age 6.  In April of this year, the National Toxicology Program (NTP) said their was “some concern” over the chemical’s safety, especially in children and infants.  Last month, the FDA declared that BPA was “safe.”  Last week, California voted against a ban on BPA in children’s bottles and sippy cups, while the NTP concluded after months of examination that indeed there remains “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A.”

Then, a few days ago, research out of the Yale School of Medicine reported that BPA exposure, at the upper limits of the levels the U.S. EPA says is safe, had “a devastating affect on the synapses in the monkey brain,” according to Yale researcher Tibor Hajszan.  Previously, most BPA research had been in rodents.  But this study wanted to examine BPA in a species more closely related to humans and in a manner more similar to human exposure–slowly and continuously.  Researchers found that BPA damages synapses, the spaces between neurons that are crucial to brain communication.  Most of the damage was in areas of the brain involved in memory, learning, and mood. (For more on this, see this article on washingtonpost.com.)

On September 16, the FDA science advisory pannel will hear arguments on whether or not to restrict BPA in can linings, water bottles, baby bottles, and other food packaging.  “Unfortunately the regulatory agency charged with protecting the public health continues to rely on industry-based research to arrive at its conclusions, rather than examining the totality of scientific evidence,” says representative John Dingell (D-Mich), chairman of the House Energy and Commerce Committe, which is currently looking into the FDA’s handling of this BPA issue.  “The FDA’s assurances of BPA’s safety are out of step with mounting scientific evidence to the contrary,” says representative Edward Markey (D-Mass). “For the sake of the health of every man, woman and child in America, we should ban BPA in food and beverage containers, especially because there are alternatives already available.”

I’m anxiously waiting to see how this drama ends up playing out.

Just this week, the FDA declared that BPA is safe.  However, there are some concerns that the studies used to come to that conclusion may have been mostly industry studies and not independent ones.  What concerns me, in addition to that, is that the American Chemistry Council is praising the FDA’s statement, while watchdog groups like the EWG are not.  I was all prepared to write a bit of a rant on this, when I stumbled across several other bloggers who already have.  So please take a look at these:

• safemama.com
• amomsblog.wordpress.com
• tryingtobegreener.wordpress.com
• zrecs.blogspot.com

You probably already know where I stand on the issue, but I’ll state it again.  I don’t care who says it’s safe, I’m going to continue avoiding BPA and phthalates and any other even remotely questionably safe chemical as much as I can.  My pediatrician told me he’d never even heard of phthalates in 2005 and not to worry about them, and just three years later, the U.S. has passed a bill banning six of them from children’s products.  I don’t want the same to be true of BPA.  Better safe than sorry…. or as is the case for a mom, better safe than feeling guilty.