November 2007 Archives

If you hear that dangerous levels of lead in lipstick, you might think, "well, good, I'm off the hook, I don't wear whatever it's called - Merry Berry Cherry Blush lipstick", say. But consumers can worry about more that certain brands of shiny red lip gloss containing high levels of lead. The US government doesn't tightly oversee chemicals in any "cosmetics". This means products we all use every day: soap, shampoo, mouthwash, suntan lotion, wart remover, towelettes, tooth whitening strips, baby oil, etc., as well as eyeshadow and nail polish. As Proctor & Gamble likes to brag: "Three billion times a day P&G brands touch the lives of people around the world".

Cosmetics are minimally regulated by the FDA. The FDA prohibits "misbranded" or "adulterated" products in "interstate commerce". This amounts to either exceedingly mundane, or exceedingly basic oversight. The containers, for instance, cannot be "so made, formed, or filled as to be misleading". Cosmetics themselves cannot "consist in whole or in part of any filthy putrid, or decomposed substance". Granted, it's comforting to know that in America, you'll probably be spared the 6:30AM surprise of patting shaving cream with lumps of decomposed rat tails onto your cheeks. But clearly with the federal bar low, industry gets a lot of latitude for formulating its products as it sees fit. While the average hand soap fails to impress us as potentially dangerous, there are quite a few products marketed in the US that contain disturbing levels of carcinogens or reproductive hazards that are banned in Japan, Australia and the EU.

There are regulations in place in the US, but people who assume that the regulatory environment of the 1970's and 1980's is still keeping unsafe chemicals off the market be surprised at the current state of affairs. For instance in the EPA's Toxic Substances Control Act (TSCA), provides regulations for chemicals in the environment. Apparently TSCA is weak enough that some people deride it as the "Toxic Substances Conversation Act". 60,000 chemicals were grandfathered in when the act was first put in place. At the 25th anniversary of the organization, Lynn Goldman, a professor at John's Hopkins University, said she realized just how flawed regulation might be when, "someone from the chemical industry got up to salute TSCA and said ""This is the perfect stature. I wish every law could be like TSCA"".

In Europe, cosmetics are regulated by the European Commission/ Directorate General Enterprise and Industry, which oversees both the competitiveness and safety of EU products. The fact that both goals, competitiveness and safety, are combined in the same organization, underlines the idea that one does not cancel the other out. As well, the EU Health and Consumer Protection Directorate regulates chemicals in cosmetics. To date, about over 1000 chemicals, carcinogens, mutagens, and reproductive toxins (CMRs), which are prohibited in European cosmetics. The Health and Consumer Protection Directorate also removes imported products containing banned chemicals or chemicals in excess of allowable levels. It recently pulled several brands of nail polish with dibutyl-phthalate, and body-care products with hydroquinone and N-Nitrosodiethanolamine.

The changes in European regulatory climate relative to the US can be seen in recent actions on cosmetics, as well as plastics, persistent organic pollutants (POPS), and in the the REACH (Registration, Evaluation,Authorization and restriction of CHemical substances) directive on chemical reporting. The general difference between the EU approach and the American approach is that in the US companies tend to reason that exposures to toxins are small, therefore harmless.The EU looks at the inherent hazardous properties of the chemical. Considering that these chemicals interact with humans and the environment from the time they're manufactured to the time they're disposed of, taking steps to understand how citizens are exposed to what chemicals and to regulate or even ban toxic chemicals seems important.

Because of the different regulations in the EU, many cosmetics are formulated differently for European and American markets. This doesn't necessarily alarm US citizens, who no doubt believe that because the US is a "litigous society", companies are motivated to keep products safe. Shapiro says this is as misguided as the notion that the federal government oversees products and therefore insures our safety. P&G, for instance, says it abides by the EU guidelines, submitting required toxicity data, and formulating its European products according to European market standards. But at the same time P&G spent $600K lobbying against the very same rules, proposed by the Safe Cosmetics Act in California, protesting that the act would create "an unreasonable and unnecessary burden". P&G is also a significant corporate sponsor of tort reform efforts in the US, including campaign donations Republican judges attentive to "business-friendly" legal reform.

In his book, "Exposed, The Toxic Chemistry of Everyday Products and What's at Stake for American Power", Mark Shapiro describes how chemical regulation in the United States has lagged since it's heyday in the 1970's and 1980's, especially in past decade. By contrast, he says, the EU is increasing it's chemical regulation, and in fact setting safety standards for products. Shapiro notes that US opposition to chemical regulation emphasizes the economic cost necessary to comply with the rules, and that US lobbyists even accuse the EU of welfare economics. However European agencies stress they're not sacrificing profit at the alter of environmental socialism, not even close. Instead, Shapiro argues that the EU, which currently manufactures more chemicals for the world market than the U.S., is taking a proactive stance on manufacturing standards that's threatening to leave the U.S. in the dust, even as the U.S. loses deals insisting that business profits trump consumer safety.

Shapiro's book covers accounts of cosmetic regulation, as well as endocrine disruptors - especially phthalates, as well as GMO's, persistant organic pollutants (POPs) (like DDT, Aldrin, Dieldrin, Endrin, Chlordane, Heptachlor, Hexachlorobenzene, Mirex, Toxaphene, Polychlorinated Biphenyls, Dioxins, and Furans), and the EU Restriction of Hazardous Substances Directive (RoHS) that regulates substances in electronic equipment (like lead, Mercury, Cadmium, Hexavalent chromium, Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE)). The U.S. consistently undermines efforts to regulate the chemicals and his telling of these events is interesting.

Shapiro's point that European leadership is leading environmental considerations across the globe might seem optimistic. A couple of years ago Acronym Required wrote about an incident involving the inclusion of an Ampicillin gene in genetically modified seeds that were sold and planted for four years in the EU and the US. Both European and US regulatory agencies failed to respond to the error (Transgenic Crops - Strife Across the Pond). It seems that government agencies, business interests, and the complicated endeavor of judging chemical toxicity would be the same on both sides of the Atlantic. However, you can certainly see the trend Shapiro describes, even in recent legislation in San Francisco and California concerning phthalates in children's toys. One reason consistently given by both state and city legislators for enacting the legislation was that Europe had already banned phthalates. And although the San Francisco law originally sought to ban bisphenol-A, this chemical was subsequently dropped from the law. Again, on bisphenol-A, the city and state seemed to be influenced by lobbyists who pointed out that bisphenol-A regulation in Europe is limited.

Shapiro makes a convincing case in an interesting book, that the EU's more aggressive stance on chemicals will benefit its economy, as well as citizens within and outside the EU.

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Acronym Required wrote about REACH, and Mark Shapiro's article in Harpers a couple months ago . We also wrote about REACH back in 2005. We've written frequently on bisphenol-A and phthalates, the environment, and government regulation.

The Environmental Working Group has a database of 25,000 health care products available in the US with estimates of potential risks. Many health care products, whether high end, organic, or cheap drugstore brands, contain chemicals known to cause cancer or reproductive health toxins. The database compares ingredient lists on the labels to databases of chemical toxins, then rates the products on a 1-10 score. Imperfect, but interesting.

States Sue EPA over Reporting

Eleven states sued the EPA yesterday for loosening the reporting standards of companies who release chemicals into neighborhoods. The suit is led by Attorney General Cuomo of New York, and joined by the states of New Jersey, Connecticut, Arizona, California, Illinois, Maine, Massachusetts, Minnesota, Vermont, New Hampshire, and Pennsylvania. The states challenge the legality of the laxer rules that allow companies to release up to 5,000 pounds of toxic chemicals without extensive reporting. This overrides the old rule, enacted in 1986 during the Reagan administration, in the wake of India's Bhopal accident, which required extensive reporting for any amount above 500 pounds.

According to the New York Times, the EPA claims that their "making a good program better". However many observers say the opposite. The complaint, filed in the Southern District Court of New York represents labor organizations, environmental and public health groups, and scientists, who all use the information to monitor and study chemical releases in the environment. As well,communities and individuals use the information to advocate for safe neighborhoods.

Thanksgiving - All Things Ottoman

As most people know, the domesticated turkey that Americans eat for Thanksgiving descends from the wild turkey, Meleagris gallopavo, native to America. The Spaniards fancied the turkey when they invaded Mexico where turkey was indigenous, and then introduced the bird to Europe when they returned in the early 1500's. However, during the expansion of the Ottoman Empire, turkeys were thought by northern Europeans to be a product of Turkey.

Europeans also for a time called turkeys "India fowl", then confused the turkey with "Guinea fowl" and gave turkeys the same Latin genus name: "Maleagris". The species name that they settled on, "gallopavo" combines the Latin for rooster and for peacock. From these confusing origins turkeys have long struggled with their identity. First they were put in their own family, Meleagrididae; but now scientists consider turkeys to be part of the pheasant family, Phasianidae, in the subfamily Mealeagidinae.

In 1934, Dr. Frank Thone, a botanist and journalist for Science News Letter, wrote that other native American plants, tobacco, corn, and pumpkin, were also assumed by Europeans to be products of Turkey. 1

The 1542 botany text by Leonard Fuchs, De historia stirpium commentarri insines, described corn and pumpkin as Turkish. The Yale medical library has scanned the plates of the wood cuts from Fuch's 1543 German translation of De historia stirpium, called New Kreuterbuch. As Thone describes, the plates for pumpkin and corn, refer to the vegetables as "Turkish cucumber", and and "Turkish corn".

Thone translated Fuchs explanation of "Turkish corn" history: "The plant here considered has been brought to us only recently from Turkey, Asia and Greece... thus far it has no Latin name other than Turcico frumentum. Corn now, is of course known as Zea mays. Thone wrote in 1934 that turkey still retained its "red fez" misnomer, while corn, tobacco, and pumpkin had been popularly reconnected to their proper American origins.

Digesting that, you can sit back in your stretchy pants and put your feet up on the ottoman...

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1Frank Thone wrote "thousands" (according to his obituary) of articles for Science News Letters, now Science News, which was started in 1921 as a part of the Science Service. He was one of the reporters who covered the Scopes trial in 1925 and sought to use the trial to educate the public about evolution.

(corrected link 11/24/07)

Wiring the Orwellian World

Yahoo In China

This week, Yahoo settled a lawsuit brought against the company by two Chinese citizens and their families. The lawsuit accused Yahoo of aiding and abetting torture under the Alien Tort Claims Act and the Torture Victims Protection Act. Yahoo had been giving Chinese authorities the names of dissidents who were then arrested, tried, and imprisoned -- guilty of using Yahoo services for pro-democracy activity. Two of these citizens, now in prison with ten year sentences, attracted the attention of the global community. In September, 2002, Yahoo turned over account information of Wang Xiaoning, who was charged by China of "inciting subversion" (creating a publication that advocated "a multiparty political system, separation of powers, and general elections"). Later Yahoo turned over information for Shi Tao, who China accused of transmitting "state secrets" (information about China's plans for handling the anniversary of Tiannamen square).

Yahoo defended its actions, saying it was bound to Chinese law. Furthermore, the questions had no place in American courts, they said, since Yahoo had: "no control over the sovereign Government of the People's Republic of China, the laws it passes and the manner in which it enforces its laws."

Yahoo In France

This is very different from what Yahoo said in a case in the French courts in 2000, when they claimed that they were an American company not subject to the laws of France. In that case Mark Knobel, a Paris resident, had found a cache of Nazi mementos being sold on Yahoo auction sites. Knobel asked Yahoo to remove the merchandise, a request that AOL had honored in a similar situation two years earlier. The company founders, Jerry Yang and David Filo were busy celebrating the dot com era. Their company namesake, "Yahoo", is one is who is "rude unsophisticated and brash", and the stock price was close to $500 a share.1 Yahoo refused to remove the Nazi items.

"'It is very difficult to do business if you have to wake up every day and say 'OK, whose laws do I follow?', said Heather Killen, a Yahoo vice president, "We have many countries and many laws and just one Internet"'

While different than their China claim, their train of thought was apt. The Internet in 1990 was a new place, a proper noun -- like Atlantis or Shamhala. Internet businesses were much closer to the manifesto issuing 1990's, when some of the Internet's first users fostered ideas about Cyberspace, the democratic, borderless social space over which sovereign governments could not lord. In the midst of e-commerce proliferation, many inside and outside of the technology grappled with the question of whether nation-states would take a lesser role.

However, French lawyers in 2000 didn't buy Yahoo's argument. French laws applied to radio and television, why would they not apply to the internet? Judge Jean-Jacques Gomez ordered Yahoo to make the Nazi paraphernalia inaccessible via the French internet. Yahoo then tried to argue that they couldn't technologically remove Nazi merchandise on sites hosted in the United States for the sake of the French. It was impossible -- how could you tell where the user was geographically located?

The court drew in expert witnesses who demonstrated that this assertion was false. Yahoo at the time was serving up French ads to French users from sites the company had mirrored in Switzerland. Yahoo's actions weren't protected under the laws of a sovereign US. In 2001 after more protracted dispute and non-compliance with the court requests, Yahoo removed Nazi merchandise.

In the Chinese case, as in the French case, Yahoo was cagey. They first testified to Congress that they had no idea of the fates that befell the Chinese whose names the company had turned over to the government. But a translated copy of the Chinese authority's warrant turned up on the internet. Congress held another hearing, and the committee's title indicated the tone the meeting would take: "Yahoo! Inc.'s Provision of False Information to Congress.". House Foreign Affairs Committee Chairman Tom Lantos (D-CA) (very active himself fighting crimes against humanity), subjected Yahoo's CEO and council to scathing rebuke, and demanded that Yang apologize to the families of imprisoned men. Shortly thereafter, a cowed Yahoo settled with the families.

Yahoo et al: Stateless to Stateful to....?

In 1990 when international discourse circled the question of whether states were relevant, Yahoo based its defense in France on the sentiment they weren't. In July, 2002, Yahoo entered China's business world with stock trading at $9.71, humbler than the 2000 highs. Yahoo was one of 300 companies to sign a document issued by the Chinese government, "Public Pledge on Self-Discipline for the Chinese Internet Industry". The companies agreed to follow various Chinese dictates aimed at cracking down on the internet's potential to democratically inform and enlighten, to question the government. The Chinese surveillance and censorship society blossomed. Few people in the business hungry US found these companies' stances disagreeable. Human Rights Watch was one who did fear the worst, warning in August 2002, that Yahoo "risks complicity in rights abuses". "If it implements the pledge, Yahoo! will become an agent of Chinese law enforcement."

Today, the US dithers about whether waterboarding is torture or not, revels in its own abundant state secrets, and wiretaps to its heart's content, covering its actions with the sinister haze of terroristic threats and legal immunity. Contractors in Iraq have upon occasion raped, killed and pillaged -- but there's always profit. The US leaps to do business with countries led by borderline or full-fledged tyrants who spout various "nationalist" ideas. Despite the current milieu, taking the moral high ground is worthwhile every now and again. Talking about "spread of democracy" serves certain ends. There are instances when the chimes of a declarative moral stance resonate with a public eager for seemingly anachronistic sentimentalities, like when a Senate committee member lambasted Yahoo during the hearings: "morally you are pygmies".

In the article "Yahoo Isn't the Only Villain", the Los Angeles Times points out that the entire Chinese national firewall, espionage program and internet surveillance system is built and supported with U.S. technology. Cisco built the firewall and supplies other technology. Skype (Ebay) scans instant messages,Google's search filters offensive ideas, and Microsoft, Dell and H.P. also participate. Many of these companies aren't new to the game, IBM supplied the technology for the efficient Nazi state too.

The head of the Chinese company, China Security and Surveillance, who also serves as the technology director of the ministry of public security that runs Project Golden Shield. The company recently incorporated as a US publicly traded company to encourage western investment. China Security and Surveillance financed itself with loans and private placements with 17 US institutional investors. China Public Security Technology and other companies have done the same thing.

The New York Times reported that the Chinese security industry was valued at $500 million in 2003 and is predicted to be 43 $billion by 2010. Finance message boards such as Yahoo's buzz with anticipation. Tom Lantos is leading the charge to set up guidelines for US companies working in China. If accomplished, it will be a feat -- businesses busily hack away at the effort.

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1In the book, "Who Controls the Internet, Illusions of a Borderless World," Jack Goldsmith and Tim Wu describe Yahoo's challenge to France's control of the internet back in 2000. They trace the history that led to the French legal battle and the position that Yahoo subsequently took with China.

Technology, Back in The Day

The site Collegehumor.com does a skit of the un-aired pilot for the Fox Show 24, back in 1994.

When Fear of the Internet Manifests as a Desire to Throw Cheerios?

In Time magazine's "When the Patient is a Googler", Dr. Scott Haig constructs a straw lady for our entertainment. His female patient "brandish[es]" information during an office visit and her unruly child spews chocolate milk and Cheerios about his office. Haig holds up his caricature of a harried mom and compares her to his ideal patient, the engineer who is "accustomed to the concept of consultation". The engineer's kids are no doubt being cared for somewhere else, and his Mr. or Ms. "Logical" probably sports a pocket protector to prevent ink from the Pilot Extra Fine Point permanent marker from accidentally marring the doctor's fine upholstery. Kudos to engineers for knowing their rightful place.

To be fair, Haig likes nurses too. They're his "favorites", because "they know our language and they're used to putting their trust in doctors. And they laugh at my jokes."

The doctor holds a seemingly exalted position in New York's medical circles. He teaches, runs a private practice, and "punts" his undesirable patient, her "mispronounced words and half-baked ideas", after only one short visit. Such skill! Such fortune! Hospitalists, emergency docs, managed care docs, brilliant and dedicated private practice doctors, nurses, lab techs, physical therapists, administrators and medical workers are often stuck with their clients -- even when said individuals taunt outrageous anti-medical ideas like "yin-yang", or "nutrition"! But imagine Haig's scenario. Imagine if after a mere twenty minutes of your insufferable patient, co-worker, doctor, or boss, you could simply opt out? You could just bid that arrogant pill adieu and never have to endure whatever blah, blah, blah, blah...again? Without sacrificing your (let's say) $500,000K+ salary? Oh, should such a world be mine! To hell with compassion.

For a man of his stature, Haig's stereotyped "brainsucker" female protagonist with her wayward toddler provokes a strong reaction -- "I soon felt like throwing Cheerios at her too", "I couldn't dance with this one". Why such indignation? In Haig's telling she knows his address, but it's hard to imagine any real rage or paranoia built around that. It's easy enough to keep an address private, and she's obviously harmless.

Haig did not write 'Googler Patient' for Acronym Required's rhetorical amusement. If we were to hazard a guess, we'd suspect there's something more, and the doctor didn't diagnose his problem correctly. We'd suggest that it's psychological. That he's upset, unsettled perhaps, thinking about how the internet might further disrupt the cozy information asymmetry implicit in doctor patient relationships. Does Google masquerade in Haig's tale as some pushy female, "rude" and "too personal"? Does "she" jostle the power structure? Does "she" psychophysiologically unnerve the doctor?

An Apple a Day....More Pablum For Busy, Distracted Minds

When patients visit the doctor they generally get one 10-30 minute office visit with the "expert". Doctors are pricey, even if insurance buffers the $200-$500 bill. "Personalized" medicine? Patients are often lucky if the doctor gets their name and age right. Stressed by whatever ails them, patients don't see doctors for a living, as doctors do patients, so they could be forgiven their unpracticed manner. Think of your dear grandmother, born in a time not too long after the town doctor made patient rounds with his horse-drawn carriage. Does she have to ape the behavior of a dispassionate engineer in order to avoid the scorn?

Many doctors agree that patients should be as informed as possible for their own health. We all acknowledge that American medicine is often a broken system. Sure "experts" abound, but complacent doctors are easy to find too. Medical errors occur in "44,000 to 98,000" patients a year according to the FDA (via Google). Patients, being human, aren't all equally subtle or adept at integrating their new found internet information with the doctor's expertise. But doctors should be able to adjust to this. They should be able to relate to inevitable unevenness in "bedside manners", and the variable ability of patients to see the body in the same way that the well-trained and indoctrinated doctor does.

There's a phenomenon at work here concerning the internet, medical information, and doctor/patient relationships. Unfortunately this Time column doesn't get around to exploring the more subtle and interesting aspects of the story.

'Fessing Up For Health

In a related piece, Tom Delbanco, M.D., and Sigall K. Bell, M.D write in "Guilty, Afraid, and Alone - Struggling with Medical Error", (New England Journal of Medicine NEJM Volume 357:1682-1683, October 25, 2007), about mutual fear on the part of patients and doctors that exacerbates suffering due to medical mistakes. They note that "because of the power dynamics between physicians and patients, questioning the expertise or skill of an authority figure is particularly fraught for the least empowered members of society". The authors have made a film for third year medical students and suggest that in the case of medical errors, there should be a forum for some sort of reconciliation: "patients and families will bring ideas to the table that expand the horizons of health care professionals".

Proust As Muse

I've just finished reading a fun book that I got at a book swap called How Proust Can Change Your Life, by Alain de Bottom. I liked it of course, although other reviewers who are more opinionated about incorporating Proust in a book title found it alternatively "clever"- "witty..funny..tonic" or "superficial..contrived..patronising".

Happily, I can stay in theme by reading a couple of new releases that not only include Proust but science too. In Proust Was a Neuroscientist, Jonah Lehrer writes about artists who, ensconced in their writing or cooking or painting, conceived of some aspect of sensory science ahead of the scientists. In Proust and The Squid, Maryanne Wolf writes about human development and reading.

On Proust's place in neuroscience, I didn't bring Proust along to fill in the empty moments between my neurobiology experiments as Lehrer did, and have yet to finish "In Search of Lost Time" -- I may not be the best judge. While Proust inspired books divert my attention, Proust stares down from the spines of seven unfinished volumes shelved up by the ceiling, mocking my frenzied schedule. Although some reviewers make it seem unique or iconically 21st century to mix literature and science, I contend that the pairing is natural. Scientists have always been a cultured lot to my mind, especially neuroscientists, and artists forever inquisitive about the natural world. Whatever the circumstances or pretenses Proust so often finds himself as muse, these two new books promise interesting reading.

Appendix: Fake News Dispersed

When a story about the human appendix not being "useless after all" hit the press and blogosphere a month ago, quite a few science blogs explained that this "new" functionality idea was flawed and carefully pointed out the problems with the research, in the midst of what was largely unabashedly uncritical enthusiasm. The writers noted that this was not new research, just a review of the literature. More importantly, the Duke authors' proposal in the Journal of Theoretical Biology that the appendix was not vestigial but served to house beneficial gut bacterial was unproven (though some deemed it interesting).

Despite the effort, I noticed that Answers.com featured the appendix story in "Today's Highlights", and alas it wasn't listed as "fake news".

Summary:

Just a thought: If bisphenol A were a therapeutic drug going to market, instead of a chemical with an established global market, and there were 700 studies (LA Times) showing hormone effector effects in animals, but also "two dozen" human studies showing the same responses in humans-- therefore if bisphenol A, the hypothetical drug, had passed through the equivalent of Phase I safety, Phase II efficacy and was well into Phase III trials-- the stock of a certain pharmaceutical company would be skyrocketing based on the evidence. Financial analysts would be jumping up and down in their Aeron chairs predicting sales of the next blockbuster drug... But bisphenol-A is not a drug. It's a chemical used in mostly polycarbonate products such as baby bottles and sport's drink bottles, but ubiquitously in toys, dental epoxies, food cans... 2.8 million tons of bisphenol A were produced in 2002. So manufacturers, politicians and organizations like the American Dental Association deny that the animal studies mean anything. They insist that bisphenol A is safe. Is it? If not why did city legislators in San Francisco decide not to restrict its use in products?

Plastic People

Chemical & Engineering News published an article August 6, 2007, titled "More Concerns Over Bisphenol A: Human Exposures are Usually as High as Those Causing Profound Effects in Rodents". The article presented evidence from four toxicology studies that "bolstered" the link between "bisphenol A (BPA) and adverse health affects". Bisphenol A is used extensively in producing certain hard plastics used for various products. It is an endocrine disruptor that in mice causes a myriad of deleterious physiological effects, and when scientists do corresponding studies in humans, they produce the same results as in mice.

Makers of bisphenol A and the chemical industry label anyone who questions the safety of chemicals a "green activist" with "anti-chemical agenda". But the American Chemical Society hardly fits into this category. When the American Chemical Society notes the "profound effect" of bisphenol A, won't industry lobbyists and Fox news temper their caustic comments towards anyone who dares questions the safety of a chemical? Will they realize how out of date and trenchant they sound and change their tune? Doubtful. As the American Chemical Society also notes, "despite growing evidence of toxic effects in lab animals, manufacturers of BPA insist that their product is safe."

It's curious that the chemical industry has manage to conceive and manufacture hundreds of thousands of chemicals for millions of "better living through chemistry" applications, but seems hamstrung by the challenge to create less toxic options. Instead, they vehemently oppose the idea of taking a toxic product like bisphenol A off the market. Once production is in place and market share is established, removing a product from the market is as much an anathema to industry as it is to the politicians and media who represent industry. Of course there are "economic repercussions" to such a move. But industries remove consumers favorite products all the time when it benefits their bottom line. In fact isn't "planned obsolescence" a foundation of capitalism? But rather than focusing on the potential profit that would come from a new, less toxic product, these industries cling like traumatized children to their old business.

Chemical & Engineering News doesn't need to tell us that the Chemical, Plastics and Toy Manufacturing industries might not be the most reliable source of information for toxicity of chemicals. This is not strange or unprecedented business practice, rather a predictable one. The car industry bucked seatbelts for years, the tobacco industry denied that dragging on cigarettes caused cancer, and the oil industry launched/launches vigorous attacks against all science and scientists who observed and predicted climate change and global warming. We've come to expect this of industries. They bombard the market with new and exciting products on the their own terms. They find infinite new uses for chemicals; for phthalates and bisphenol A that make plastic products pliable or rigid or just plastic-y so. They create and manufacture plastic products en force, to strong demand, with impressive budgets that buy marketing, press releases, opinion pieces, disclaimers, liability notices, and a bevy of braying lobbyists and complicit politicians.

When it comes to our health, consumers are learning not to depend on industry information. Since Acronym Required first started reporting on bisphenol A and phthalates a couple of years ago, public awareness of the potential dangers and the lack of industry transparency about them has grown tremendously. Despite this self-determination, however, consumers remain dependent on the media to inform us, and the legislature to protect us. We're the largest constituency of politicians, and the largest consumer group of newspapers, and TV networks. However to the media and politicians, citizens are just one of many constituencies -- not necessarily the loudest, the most consistent, or the most generous. Politicians and the media are also indebted to their own bottom line; to donors, partner businesses, trade groups, and advertisers, not only readers and voters. Health and environmentally conscious citizens sometimes discover that their influence is relatively small, just one line on a whole balance sheet of competing interests.

The Press and Poison, The Press and Pills

Media coverage on potential toxins can be good, as in a USA Today article on October 30th about bisphenol A, but it can also be confusing if not downright bad. Consider the editorial decisions that Los Angeles Times made last month, in publishing an article titled: "Some Chemicals May Affect the Reproductive System, Growing Research Suggests. But as Consumers seek Alternatives, Scientists Point out that Human Studies are Few."

Discussing the bisphenol A, the article relayed the warning of a panel of 38 scientists working for a EPA and NIH panel on bisphenol A, who surveyed "700 studies of bisphenol A". The scientists concluded:

"human exposure to BPA is within the range that is predicted to be biologically active in over 95% of people sampled. The wide range of adverse effects of low doses of BPA in laboratory animals exposed both during development and in adulthood is a great cause for concern with regard to the potential for similar adverse effects in humans."1 [emphasis ours]

Said the Los Angeles Times "the vast majority of studies" looked at BPA effects in animals, but "only two dozen studies measured levels of the chemical in people, and three have examined the health effects of everyday exposure to the chemical". "Hundreds of studies" in lab animals, the article notes, found that "bisphenol A damages the reproductive system by interfering with the effects of reproductive hormones. Male rats have reduced sperm counts and enlarged reproductive glands; female rodents have altered mammary glands, hit puberty faster than normal and have trouble getting pregnant."

If bisphenol A were a therapeutic drug going to market, and there were 700 studies, many in animals, but "two dozen" human studies showing the same responses in humans as mice, and if therefore the hypothetical drug had passed through the equivalent of Phase I safety, Phase II efficacy and was well into Phase III trials, the stock of pharmaceutical company would be skyrocketing. Financial analysts would be jumping up and down in their Aeron chairs predicting the company's astronomical growth based on the "exciting" news. They would be exclaiming about "surpassed expectations" of a "new blockbuster drug", and headlines would be shouting about the "cure" for diabetes, cancer, heart disease, or arthritis in very very large font.

For an extreme example of this see the Times Online article this week titled "'Magic Bullet' Devised to Beat Cancer", a piece optimistic about a strategy to cure cancer based on an experiment that "eliminated ovarian cancers in five out of six mice, and greatly reduced the tumour's size in the sixth mouse." Six mice. Yet when it comes to evidence that points to the deleterious effects of bisphenol A based on hundreds of studies in mice, the Los Angeles Times chooses a presentation that intermingles hair raising evidence with reminders of how meaningless this all is; the studies are "small and few", "few", "nonexistent", "paltry", "little", and "we mostly don't know" -- their list of belittling adjectives is impressive.

"Paltry" Proof of Phthalates

There is even stronger data on phthalates than there is on bisphenol A. The LA Times acknowledges that "phthalates and other chemicals" are toxic to animals, but emphasizes that "in humans, the data are still inconclusive". Combining a couple of different ideas the writer says:

...In fact, when it comes to humans, the data are nearly nonexistent. Very little research has examined the health risks associated with consumer use of plastics. And because of suggestive evidence from studies of lab animals, much of that research has focused largely on chemicals in two types of plastics: those marked with recycling No. 3 and No. 7.

No. 3 is polyvinyls that contain phthalates. Despite the paper's assurances, here is what the article actually says about phthalates in animals:

"...high doses of phthalates cause a conglomeration of health effects that suggest the chemical may either block the activity of male sex hormones (such as testosterone) or hamper their synthesis in the developing embryo...[and]...lowered testosterone levels; a shortened distance between the anus and scrotum; testes that fail to descend; reduced sperm counts; and defects in the urethra, prostate and seminal vesicles."

As for humans, the author notes that the National Toxicology Program issued a report about DEHP (a particularly worrying phthalate)1 expressing "'serious concern' that critically ill male infants exposed to the plasticizer could suffer damage to their developing reproductive systems". In 2002 the FDA notified healthcare providers that they shouldn't use tubes, bags or equipment containing DEHP "when treating premature babies, adults undergoing dialysis, heart transplant recipients and women pregnant with male fetuses", because the DEHP leaches out. (Many hospitals are currently phasing out DEHP.) The LA Times also lists the following research results for phthalates in humans:

  • A study showing elevated mono-(2-ethylhexyl) phthalate in men corresponded with "50% more sperm DNA damage ."
  • A study showing that men with elevated monobutyl phthalate "were more than three times as likely to have a low sperm count than men with the lowest levels of the phthalate"
  • A study of "85 mother-and-son pairs, showing that, as in rats", higher levels of phthalates were associated with "shorter ano-genital" distance in infants, as well as "undescended testes, smaller scrota and smaller penises". The level of phthalates associated with these reproductive effects was lower than what was considered acceptable by the EPA.
  • Another study showing that the longer newborns spent in intensive care the higher their levels of phthalates.
  • Another study showed that high levels of phthalates correspond to "decreased levels of thyroid hormones".
  • Studies showing increased levels of phthalates in dust corresponded to "decreased lung function" in men and asthma in children.
  • A study showing that increased levels of phthalates was also linked to "insulin resistance" and larger waist size in men.

None of this seems particularly healthful. The European Union, Mexico, Japan, Fiji and Argentina have banned phthalates. But the LA Times, either in a desperate attempt to balance competing interests or because they have phthalate syndrome, has a higher bar of proof than Fiji. The paper reminds us once again that phthalates data is in its "infancy", and bisphenol A data "in the womb".

In light of what scientists tend to consider proof, if this were a drug going to market, wouldn't such evidence be trumpeted, as proof of efficacy? Indeed, drugs for breast cancer, leukemia, Huntington's Disease, brain tumors, Down's Syndrome, MS, various tumors, Alzheimer's, Gleevec resistance, diabetes, H5N1 infection, lupus, and hundreds more -- are touted as showing "promise" based on far less "data in mice". If this were a potential drug wouldn't the money be pouring into determining the proper dosage? Instead, any testing of these hazardous chemicals is incumbent largely on government and occurs, slowly, slowly, and only as "time and resources allow", as San Francisco recently put it in legislation on phthalates.

Precautionary Principle

When public concern is high enough, as it is for bisphenol A and phthalates, a toxin might catch the attention of politicians. But even then, when push comes to shove, politics can water down the most well intended legislation. Take, for example the short sequence of events in San Francisco's recent legislation effort on bisphenol A and phthalates.

  • On June 6, 2006, the San Francisco supervisors passed a ban on phthalates and bisphenol A .
  • On October 25, 2006, bisphenol A manufacturers, the American Chemistry Council, California Retailers Association, California Grocers Association and Juvenile Products Manufacturers Association and a local store called CitiKids sued the city.
  • On November 16, 2006 manufacturers of phthalates, the California Chamber of Commerce, the Toy Industry Association and Ambassador Toys, a local store, filed another lawsuit against the city (notice, always a local merchant as a plaintiff?).
  • November 19, 2006, the San Francisco Chronicle published an article showing that the chemicals showed up in plastic toys, despite the fact that they were labeled free from chemicals. The story alarmed parents. It also gave support for the supervisors' subsequent changes to their ban based on the fact that plastic products lacked any labeling and enforcement of the ban would be too difficult.
  • November- January, 2006: The Chronicle published a couple of opinion pieces that opposed the ban, including ones from the American Council on Science and Health (ACSH - an industries lobby group), and the American Plastics Council. The Chronicle also ran its own editorial, writing that however "well-intended", the ban lacked the "appropriate planning and consultation with public health authorities, retailers and toy manufacturers."
  • On December 1, 2006, the ban was slated to go into effect, but it was postponed by city officials, who told businesses the city would wait until after the holidays to begin enforcement.
  • On January 23, 2007, Supervisor Angela Aliota-Pier proposed changes to the ban which were approved by the Board of Supervisors in April, 2007. All bisphenol A legislation was removed. Instead of banning certain phthalates, under the changed legislation labs would be hired to test specific products over the next couple of years (as resources permitted, the legislation noted). The products were only those that were specifically meant to be put in the mouths of children under three. If these products had certain levels of phthalates sale of those specific toys could be punishable. The fine for the first offense would be $100.
  • In response to the amended legislation Bisphenol A manufacturers and parties of that lawsuit dropped their case against the city.

The ordinance that was eventually passed seemed to take in mind "retailers and toy manufacturers", as the of the San Francisco Chronicle had suggested. The city understandably pushed some of the work up to the state and federal levels. The supervisors say they intend to remain abreast of developments in bisphenol A research. But if San Francisco's citizens were looking for guidance from the city on which plastic toys they should allow their children to teethe on, at what age, or whether using bisphenol A containing Nalgene bottles for water might cause breast cancer, they are still left to their own devices.

The state has also passed a phthalates bill (not bisphenol A) sponsored by Fiona Ma. Governer Schwarzenegger commented upon signing, "I do not believe that addressing this type of concern in the legislature on a chemical by chemical, product by product basis is the best or most effective way to make chemical policy in California". It remains to be seen how California will enforce the legislation.

The San Francisco supervisors invoked the "precautionary principle" when they proposed their first ban in June of 2006. There is a huge body of literature and argumentation about the precautionary principle which we're going to skip over here, but basically it says "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically".

Specific to the examples of phthalates and bisphenol A, what really does it really mean to say that "cause-and-effect relationships are not fully established scientifically"? What about the standards we use for drug development? Wouldn't all these results in BPA and pthalates "establish" the science if this were a drug? If this were drug development with a potential market similar to the size of the population effected by BPA and phthalates use, the pharmaceutical company would be pouring money into further testing. Despite this reasonable sounding premise, the precautionary principle consistently fails to gain traction with city, state and federal politicians, who are realistic to all interests.

If the city is "precautionary", it's NOT on the side of health or the environment, but (if inadvertently), on the side of industry. While San Francisco has made a admirable public statement about these chemicals its hard to see how this is going to diminish the threats to kids. Since plastic toys aren't labeled, is the city going to go into the plastics product testing business? What city can afford to regulate products? I'm not criticizing politicians -- this is the system we have -- but let's be realistic about implementing the "precautionary principle". Does it even make sense for politicians to invoke the phrase? Perhaps at the federal level or state levels we could be precautionary. But on the local level, so far it looks more like the "pragmatic principle": all interests considered.

Perhaps the precautionary principle is only personal ideal for individuals to follow. Fortunately, to be optimistic, individual families can decide to make product choices (basically by finding plastic alternatives like glass and wood) despite inevitably slow legislative efforts and still conflicting -- though on the whole increasingly good -- coverage in the media.

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1 A second study released by the National Toxicology Program concluded that bisphenol A raised "some concern" about "neurological and behavioral effects in developing fetuses, infants and young children." This study was controversial, as it was conducted after the original contractor, Sciences International, was fired by NIH under a cloud of conflict of interest concerns. Acronym Required documented the conflict of interest issues.

Acronym Required also wrote about bisphenol A in the following articles:

Plastic Bottles- Protecting Your Baby, by the ACC (July, 2005)

Bisphenol-A and Phthalates Bill in California (January, 2006)

San Francisco Bans Bisphenol A, Phthalates (July, 2006)

San Francisco phthalates & Bisphenol A Ban (November, 2006)