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 Will they realize how out of date and trenchant they sound and change their tune?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)
