FDA: “Bisphenol A Is Safe”, (Cough-Cough-Gack, Chokes on Evidence)
What’s up with governmental agencies and their policy on Bisphenol A? At first glance, it doesn’t make any sense at all.
Here is a chemical with a long list of nasty effects on human health. It is used for baby bottles, pacifiers, as a lining in tin can food and in all kinds of plastic, including food containers. The FDA has set a limit of 5000 μg/kg bw/day which is 200,000 times higher than the level at which adverse effects are seen in studies.
Hundreds of studies document a scary array of toxic effects at very low doses, but the the regulatory agencies just say – “Naw, no problem, don’t worry”. Only they use more words. Here is an example of what they say:
Many of the FDA-regulated products — like the water and infant bottles containing BPA — have become an integral part of the busy lives that we all lead. The FDA of the 21st century continues to modernize to keep pace with advancements in science and technology and the availability of such new products — and as the science involved continues to be more complex, we continue to improve our process of making science-based regulatory decisions.
– Andy 1
Who is Andy? Andrew C. von Eschenbach, M.D., the former commissioner of the United States Food and Drug Administration
What is he saying?
[...] infant bottles containing BPA — have become an integral part of the busy lives that we all lead [...]
Is he trying to say that as a matter of convenience we want to give our infants high doses of potent toxic substance? There are no substitutes? Without BPA we cannot feed our newborn?
Ridiculous.
They specifically say that current levels are safe even for infants and children. So, obviously they must have spent a lot of time analyzing all available data to make sure they do not put children in harms way.
OK, let’s see where the FDA looked to find the data for their calculation of a realistic safety limit.
Did they have a comprehensive look at the large body of studies that document worrying effects on health at low doses of Bisphenol A?
They had a look — much in the same way as you might look at something that the cat brought in, then they raised irrelevant objections about route of exposure, claiming only oral exposure can be relied upon and used this an excuse to ignore a very large number of studies.
Of course they ignored the study that showed that actual serum levels of BPA is what is relevant, regardless if it is injected or ingested: 2
“…the large numbers of BPA studies that used non-oral administration at very low doses during the neonatal period should not be dismissed by scientists or the regulatory community based on route of administration.”
The FDA instead based their conclusion about the safe level on two rodent studies sponsored by the American Plastics Council! 3 4
That is, they have ignored over a hundred studies, including a large number of high quality academic studies, which means the limit is based entirely on industry “science”. One of the two industry studies has been widely criticized by (real) BPA experts for fatal design flaws and the other has not been published in a peer-reviewed journal.
Isn’t that a little odd? Mind you, the FDA is not the only government agency exhibiting odd behaviour.
MORE ODD BEHAVIOUR
The EPA has been dragging their feet faced with new information on Bisphenol A toxicity. The BPA manufacturing industry has been directly involved in a NIH led toxicity evaluation of BPA through a consulting firm named Sciences International. They were subsequently fired when the conflict of interest was widely reported and investigated but the material they produced was used as if it had come from a reliable source.
Academic research has faced a torrent of bad industry science. The history of Bisphenol A regulation and research is filled with controversy, lies and corruption. 5
Why? Business as usual? Yes and no. Bisphenol A is special. Read on to learn why the industry perceives new safety standards to be a serious threat.
So when the rest of the world are on track for phasing out bisphenol A – Canada, 10 US states, Wal-Mart, Toy’s-R-Us, baby bottle manufacturers – the FDA protects the chemical industry and the multibillion-dollar market for bisphenol A, and show very little concern for the mountain of evidence showing bisphenol A have a wide range of detrimental health effects, in particular for infants exposed during critical stages of development. Effects from bisphenol A induced during development will produce alterations that persist throughout life.
Bisphenol A is commonly used to make clear polycarbonate plastic for consumer products, such as baby bottles and linings in food containers, meaning most people are exposed to it in all stages of life. Not suprisingly, In 2007, a panel of experts on bisphenol A concluded that the average levels in people are higher than the levels causing damage to animals in studies. 6
The continued feet dragging by government agencies in the face of hard evidence may in part be explained by the fact that they know they stepped in a big pile of dirt and their footprints can be traced decades back in time, showing how they again and again ignored the evidence of harm.
What harm has been documented?
| Dose (µg/kg/day) | Effects | Study Year |
|---|---|---|
| 0.025 | Permanent changes to genital tract | 2005 |
| 0.025 | Persistent changes in breast tissue that predispose cells to hormones and carcinogens | 2005 |
| 0.2 | Decreased antioxidant enzymes | 2003 |
| 2 | Increased prostate weight 30% | 1997 |
| 2 | Increased aggression | 2003 |
| 2 | Lower bodyweight, signs of early puberty and longer estrus | 2002 |
| 2.4 | Decline in testicular testosterone | 2004 |
| 2.5 | Immune system impacts | 2003 |
| 2.5 | Breast cells predisposed to cancer | 2007 |
| 10 | Prostate cells more sensitive to hormones and cancer | 2006 |
| 10 | Insulin resistance, chronic hyperinsulinemia | 2006 |
| 10 | Decreased maternal behaviors | 2002 |
| 20 | Damage to eggs and chromosomes | 2002 |
| 20 | Disrupted neocortical development | 2006 |
| 30 | Reversed the normal sex differences in brain structure and behavior | 2003 |
| 30 | Hyperactivity | 2004 |
| 50 | EPA human exposure limit | 1998 |
Children can recieve up to 13 µg/kg/day of bisphenol A if they are fed canned formula using polycarbonate baby bottles. How does this dose compare to the most sensitive animal studies? Those studies show effects at 0.025 µg/kg/day. That means babies receive a dose that is 520 times higher!
INDUSTRY STRATEGY
As usual when industry are caught endangering lives, they follow the tried and tested approach of sponsoring studies that are designed to show no effect, similar to the strategy used by the tobacco industry, dental industry (mercury in amalgam) and vaccine industry (mercury in thimerosal). This way they can postpone regulation and compensation claims, saving tremendous expenses and prolonging the profit (and the harm) generated by the product.
WHY IS THE INDUSTRY SO WORRIED
Bisphenol A is particularly interesting because it is a endocrine disrupting chemical. It does not follow the normal dose-response curve. The chemical industry in general are scared to death that the bisphenol A debacle could force regulatory agencies to modernize the safe level calculations they use, causing all endocrine disrupting chemicals to get much lower safe levels. This would be catastrophic for manufacturers of pesticides and a vast range of other endocrine disrupting chemicals, so the whole chemical industry vehemently oppose any regulatory decisions that would reclassify bisphenol A toxicity.
When Fred vom Saal published his landmark studies on low-dose Bisphenol A toxicity, he immediately discovered he had awakened a sleeping dragon: 7
“The moment we published something on bisphenol A, the chemical industry went out and hired a number of corporate laboratories to replicate our research. What was stunning about what they did,” vom Saal says with a mix of outrage and bemused disbelief, “was they hired people who had no idea how to do the work.” 8
Shouldn’t we trust that the chemical industry are on a mission to find the truth? Are they really abusing science to protect themselves? Unfortunately, there is no doubt whatsoever that that is what is going on here.
DISINFORMATION
By the end of 2004, Fred Vom Saal and his team had identified 115 published studies on the effects of low doses of bisphenol A.
“They also found a troubling trend. Ninety percent of government studies found significant effects of bisphenol A at doses below the EPA’s lowest adverse effect level, but not a single industry study found any effect.” 9
Other research teams are also very well aware of the chemicals industry’s efforts to discredit the science around BPA low dose toxicity.
This strategy has been somewhat successful. It has enabled the industry-infested governmental agencies to cover their feet-dragging in a cloak of confusing science. It doesn’t confuse the scientific community, but by the time these issues has filtered down to the media, it is difficult for most people to tell what is up or down.
“Honesty in industry is not a requirement,” vom Saal says. “As a matter of fact, the willingness to be dishonest seems to be the criterion for these people being hired and representing the chemical industry. We’re playing on a very uneven playing field when we talk to them.” 10
A scientist with Dow Chemical, also a representative of the Chemical Manufacturers Association has been accused of trying to bribe Frederick vom Saal at a meeting attended by several other scientists. 11
INDUSTRY MISTAKES
But the chemical industry has not been very agile in their maneuvers. Their walrus-like efforts has created enough waves in the water to attract attention from Congress and the House of Representatives.
Congress is investigating the Weinberg Group, a chemical industry consulting firm, for its role in downplaying the health effects of bisphenol A and other chemicals. 12 The Weinberg Group is known for their work for the alcohol and tobacco industries.
“The chemical industry’s efforts to hide or misrepresent the hazards of its product have been so blatant that Congress has felt the need to intervene,”
— Dr. Jennifer Sass, a scientist with NRDC.
The Energy and Commerce Committee in the House of Representatives is investigating the FDA’s approval of BPA and legislation to ban BPA has been introduced by Congressman Edward J. Markey:
“Since the regulators are asleep at the wheel, I’ve introduced legislation to ban BPA in all food and beverage containers, and will continue to work to ensure that it is enacted into law.”
— Congressman Edward J. Markey (D-MA)
The FDA is plotting an increasingly lonely course over deep and icy waters. Other governmental agencies seem to take the mountain of evidence seriously, contradicting the FDA.
The National Institutes of Health in a report has raised concern about BPA’s effects on fetal and infant brain development and behavior. 13
Another report by the NIH and the U.S. National Toxicology Program (NTP) agrees and adds that there is concern for effects on the prostate gland, mammary gland, and an decrease in the age for puberty in females as well as birth defects and reduced birth weight and growth. 14
A torrent of recent studies reinforce the status of Bisphenol A as a incredibly broad-spectrum toxic agent in low doses. Examples include studies showing
- that BPA produces an error in cell division called aneuploidy that can cause spontaneous miscarriages, cancer, and birth defects in people, including Down Syndrome. 15
- that low doses of BPA may cause obesity in humans. 16
- a link between low doses of BPA and Type II diabetes. 17
- a link between BPA exposures and miscarriages in a group of Japanese women. 18
Exposure to BPA early in life can cause disease to emerge much later. The broad toxicity of BPA can be explained by the fact that BPA is capable of re-programming over 200 genes that control the growth and repair of almost every organ in the body. 19
CHRONIC DISEASE
A very disturbing question has been raised by some researchers. Is the amount of BPA we have been exposed to for decades significantly contributing to increased rates of the population-wide emerging diseases of recent years including breast and prostate cancer, cardiovascular disease, diabetes, obesity, infertility, and polycystic ovarian syndrome?
The results of the low-dose animal studies and the actual levels detected in the population directly imply this to be a possibility.
This is not just pure speculation. Just recently, a study was published in the Journal of the American Medical Association reporting that Americans with the highest levels of BPA in their urine are more likely to have cardiovascular disease, type 2 diabetes and liver enzyme abnormalities. 20
More studies is needed to see if BPA is directly causing human disease, or if the data simply is the result of an association between an unhealthy lifestyle and more frequent use of plastic food containers. The animal data from a large number of studies seem to imply there could be a causal relationship.
BETTER LIVING THROUGH CHEMISTRY
The extremely odd and untenable position the FDA have taken on this issue makes no sense. Who gains from having the FDA allowing high levels of BPA besides the plastic industry?
The pharmaceutical industry. They have a much stronger influence at the FDA and they will not have to take the blame for making a lot of money from diseases caused by BPA. Have they exerted any influence in the case of Bisphenol A? That remains to be seen.
It is very convenient for an industry that thrives on higher rates of disease to see a rise in chronic diseases for which there are no known cause and no known cure. It provides revenue for long periods of time. Also, when the number of environmental toxins we are exposed to increase, the complexities in finding the cause of chronic diseases grow.
For the pharmaceutical industry, bisphenol A is the best thing since sliced bread.
BPA seem to be able to be a factor in a very diverse range of diseases. It has been implicated even in schizophrenia 21 and learning and memory impairment. 22
There have been a tremendous increase in autism and attention-deficit hyperactivity disorder (ADHD). BPA has been suggested as a possible cause, as has mercury in vaccines. 23
Is this the tip of an iceberg?
The knuckles of the FDA helmsman’s hands are turning white as they are gripping the steering wheel with the force of billions of industry dollars. Where are they heading across the icy waters?
- 1 Andy’s Take – “BPA: The Science, Evaluation and Safety” (pdf) ¶
- 2 Taylor JA, Welshons WV, vom Saal FS. 2008. No effect of route of exposure (oral; subcutaneous injection) on plasma bisphenol A throughout 24 h after administration in neonatal female mouse. Reproductive Toxicology 25(2): 169-76. ¶
- 3 EWG: “FDA Cites Discredited Industry Science in Justifying High Levels of Contaminants in Infant Formula“ ¶
- 4 EWG: “FDA Is Challenged on Toxic Chemical in Baby Bottles” ¶
- 5 EWG: “Timeline: BPA from Invention to Phase-Out” ¶
- 6 vom Saal, Fred. Et al. (July 27, 2007). “Chapel Hill bisphenol A expert panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure”. Reprod Toxicol. 2007 Aug-Sep;24(2):131-8. Epub 2007 Jul 27. ¶
- 7 EWG, What the Chemical Industry Doesn’t Want You to Know, Elaine Shannon, Investigative Editor, September 2008. ¶
- 8 Liza Gross, “The Toxic Origins of Disease” PLoS Biology Vol. 5, No. 7, e193 doi:10.1371/journal.pbio.0050193 ¶
- 9 Liza Gross, “The Toxic Origins of Disease” PLoS Biology Vol. 5, No. 7, e193 doi:10.1371/journal.pbio.0050193 ¶
- 10 Nadia Pflaum, “Missouri biologist Frederick vom Saal and his team exposed the dangers of bisphenol A — and earned the wrath of the plastic industry.” Pitch Article, 2008-04-24. ¶
- 11 Nadia Pflaum, “Missouri biologist Frederick vom Saal and his team exposed the dangers of bisphenol A — and earned the wrath of the plastic industry.” Pitch Article, 2008-04-24. ¶
- 12 “Congressional Probe Targets Consulting Group”, Integrity in Science Watch, Center for Science in the Public Interest. ¶
- 13 National Toxicology Program, U.S. Department of Health and Human Services “CERHR Expert Panel Report for Bisphenol A” (pdf) ¶
- 14 Since you asked - Bisphenol A: Questions and Answers about the Draft National Toxicology Program Brief on Bisphenol A, National Institute of Environmental Health Sciences. ¶
- 15 Hunt PA et al., Bisphenol A causes meiotic aneuploidy in the female mouse. Current Biology. 2003;13:546-53. ¶
- 16 Masuno, H. et al. (2002), “Bisphenol A in combination with insulin can accelerate the conversion of 3T3-L1 fibroblasts to adipocytes.” J. Lipid Res. 43: 676-684. ¶
- 17 Alonso-Magdalena P et al. 2006, The estrogenic effect of bisphenol A disrupts pancreatic beta-cell function in vivo and induces insulin resistance. Environ Health Perspect 114(1): 106-12. ¶
- 18 Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino T, Suzumori K. 2005. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod 20(8): 2325-9. ¶
- 19 Myers JP. 2006. “Good genes gone bad.” American Prospect, April 2006. ¶
- 20 Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults, Iain A. Lang, PhD; Tamara S. Galloway, PhD; Alan Scarlett, PhD; William E. Henley, PhD; Michael Depledge, PhD, DSc; Robert B. Wallace, MD; David Melzer, MB, PhD
JAMA. 2008;300(11):1303-1310. Published online September 16, 2008, (doi:10.1001/jama.300.11.1303). ¶ - 21 James S. Brown, Jr, “Effects of Bisphenol-A and Other Endocrine Disruptors Compared With Abnormalities of Schizophrenia: An Endocrine-Disruption Theory of Schizophrenia”, Schizophrenia Bulletin Advance Access published online on January 31, 2008 Schizophrenia Bulletin, doi:10.1093/schbul/sbm147 ¶
- 22 Martin Mittelstaedt, Bisphenol A may impair learning and memory, Globe and Mail, September 4, 2008. ¶
- 23 Kimura-Kuroda J, Nagata I, Kuroda Y., “Disrupting effects of hydroxy-polychlorinated biphenyl (PCB) congeners on neuronal development of cerebellar Purkinje cells: a possible causal factor for developmental brain disorders?”, Chemosphere. 2007 Apr;67(9):S412-20. Epub 2007 Jan 16. ¶
Posted: November 10th, 2009 at 03:16 →
Evidence of a campaign to scare people into consuming more BPA has been unearthed by the Environmental Working Group, The Milwaukee Journal Sentinel and The Washington Post. Companies involved in the plot include Coca-Cola and Del Monte.
Short article at EWG
Leaked document
And the FDA apparently thinks Mercury and Bisphenol-A are OK. How is it possible to have an agency that goes out of its way to harm children? It’s completely controlled by the industry. The leaked document provide a rare glimpse into the dark waters where these monstrous corporate giants swim. Only the glowing lure is normally visible.