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A variety of polycarbonate bottles, including the popular Nalgene shatter-free bottles contain the chemical bisphenol A. In sufficient quanitities the chemical is believed to disrupt hormones, but the FDA concludes in an early report that the levels in plastics are low enough not to be harmful.
Could a common chemical found in plastics be toxic? -- the FDA says no

There are plenty of health concerns to consider these days.  With some doctors worried about the possible effects of cell phones on the human body, components of our everyday lives that seem immovable have been called into question.

Another major health concern is possible toxins from plastics.  Some plastics contain chemicals that are carcinogenic and some have speculated that the minute traces of the chemical that leaches into the drinking water steadily with time could cause cancer.  Other chemicals are thought to be not primarily carcinogenic, but to disrupt hormones and wreak havoc upon the human body in other ways.

Among the plastics that fall into the latter category are those made by Nalgene.  Nalgene leaches a compound bisphenol A, which in animal tests has been shown to lead changes in behavior and the brain and possibly reduce the survival and birth rate of fetuses.  It is thought to have similar effects on the human body.  Bisphenol A is used in the plastic and in other applications as a hardening agent.

The debate is particularly fierce due to some of household products that contain the chemical -- Nalgene shatter-proof drinking bottles, Nalgene baby bottles, and canned food (bisphenol A is used to seal cans).  As these items are all ingested there is much concern that human health may be adversely affected.  It is also found in many other household products such as plastic sunglasses and CDs.

Not so, the Food and Drug Administration concluded last Friday.  While many are concerned, they say they have reviewed the research and believe the levels of the chemical found in household items to be tolerable by the human body and are not a threat to infants.  The conclusions were presented in a draft report on the topic.

The decision was lauded by the American Chemistry Council, a Political Action Committee (PAC) and public relations organization who seeks to improve the chemical industry's image.  Steve Henges, an executive director with the council, states, "FDA is the government agency we rely upon to assess food-contact products. They've assessed this issue in great detail and their conclusion is very reassuring."

Critics blasted the report, though; as they say it relied heavily on studies funded by the plastics industry and ignores studies by leading medical experts.  Pete Myers, chief scientist for Environmental Health Sciences complains, "It's ironic FDA would choose to ignore dozens of studies funded by [the National Institutes of Health] -- this country's best scientists -- and instead rely on flawed studies from industry."

The FDA decided to revisit the topic on the chemical, which has been used for decades, due to the federal National Toxicology Program decision that there was "some concern" that the chemical could be harmful to infants.

Sufficient levels of bisphenol A can cause negative physiological effects in humans, the FDA did conclude.  It also reported that 93 percent of American had traces of bisphenol in their urine, according to the Centers For Disease Control and Prevention.  However the FDA concluded that the amount of the chemical leaching from household products falls thousands of times short of harmful levels.

The FDA will continue its analysis of the chemical in September with outside advisers debating the compounds safety at a September meeting.  The final report is being anticipated by lawmakers as it may influence their legislation.  Canada is currently considering banning the compound in baby bottles and California, New Jersey and at least 10 other states are considering banning its use in children's products.

The outcome will have a significant effect on the chemical industry as 6 million pounds of bisphenol are produced yearly.  Dow Chemical, BASF, and Bayer AG are among the largest producers.  They and their representative, the American Chemistry Council, hope that the FDA will conclude in its final report that the chemical is not harmful.



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All Others Bring Data
By clovell on 8/18/2008 11:18:17 AM , Rating: 4
I have some experience working with the FDA, and I have to say they're generally a pretty tough crowd. Studies based on grants are generally not large-scale, well-designed studies. They certainly have their merits and there certainly are some good ones, but large, randomized, parallel studies cost a lot of money - often much more than a grant can provide. The FDA considers not only the design of a trial, but also the data and the statistical methodologies employed.

I really think it's time that people get over stigma that's given to large industries. Without these corporations there would be little innovation brought to the masses. It's time to accept the reality that science is not conducted in some ivory tower, and, as much as many scientist try to keep their work free of bias, sketchy data, and just plain bad luck, it hardly, if ever, happens.

It's entirely plausible that they are wrong on this, but it seems rather unlikely. Still, it's good to see that debate continues - at least this way, people who want to can decide for themselves.




RE: All Others Bring Data
By johnnyMon on 8/18/2008 12:37:04 PM , Rating: 2
Perhaps you are right, but I don't trust any federal agency under the Bush administration to do anything that benefits the citizenry when big business would pay a price.


RE: All Others Bring Data
By tmouse on 8/18/2008 1:28:37 PM , Rating: 3
So you do not trust the government and you do not trust corporations. You have a lot of work to do by your self. Seriously though I like the way people assume that corporate studies are never peer reviewed. Keep in mind all NIH studies are government funded. It seems to me the vast majority of this Bisphenol A stuff is total mouse milking. There are numerous studies showing that the amounts of transfer are 3-4 orders of magnitude less than the maximal recommended doses which have a reasonable safety margin already built in. Studies that have shown higher levels use extreme conditions generally above 50 degrees C and in the presence of 50% ethanol or pure oils. There are studies showing dust contains as much as some samples. The biological effects use 2-4 orders of magnitude higher doses to see the neurological or genotoxic effects and most use direct injection of the compounds. While I will not say this stuff is harmless I would not lose any sleep over it.


RE: All Others Bring Data
By BladeVenom on 8/18/2008 2:18:26 PM , Rating: 5
Even with these modern chemical concoctions. I'm switching back to good old fashioned lead. ;)


RE: All Others Bring Data
By Screwballl on 8/18/2008 1:35:51 PM , Rating: 4
quote:
I don't trust any federal agency under the Bush administration to do anything that benefits the citizenry when big business would pay a price.


really? Considering most of the department heads and officials have all had their positions at least since the Clinton days and many since Regan, Bush #1, Carter and so on. So lets blame the presidents of the past 3 decades for the allowance of dangerous chemicals in drinking bottles...


RE: All Others Bring Data
By shiner on 8/18/08, Rating: -1
RE: All Others Bring Data
By YoshoMasaki on 8/18/2008 12:44:13 PM , Rating: 1
Ignorance v. Knowledge, 10M B.C. Version

Ogg: Ooh! ooh! Me smell danger! Danger in rock! Ogg no drink from rock!

Ug: Ug mama also think danger, rock! Rock kill small Ug, no good!

Tarzan: Stop spreading FUD you morons, the wizards say its safe. And anecdotal evidence has proven worthless on everything from aspartame to silicone breast implants - when will you stop believing in the inflated importance of your samples of "1"?

Ogg + Ug: Haha Tarzan dumb Tarzan die by rock, Ogg and Ug smart!


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