STATS ARTICLES 2009

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Consumer Reports BPA study filled with factual errors
Trevor Butterworth, Nov 2, 2009
Consumer Reports made so many factual errors in presenting its data on BPA in canned goods that no-one could have possibly read the actual research. Call for ban on chemical puts public at risk from deadly food borne pathogens.

Consumer Reports have come out with a purported investigation into the chemical Bisphenol A that shows scant familiarity with any of the risk assessments of the chemical. Given that BPA is used to prevent food spoilage in cans, and given that food spoilage can lead to bacterial infection putting people at risk from botulism, and given that there is no safe and effective alternative as yet for BPA, these errors and exaggerations and omissions are not trivial. Consumer Reports seems to be oblivious to the extensive research on BPA carried out by the European Union, the Environmental Protection Agency, and others, all of which refutes the magazine’s claims about the chemical.

1. CR Claims:
For Some People, Dietary Exposure Could Approach Levels Shown to Cause Harm in Animal Studie…

False:
The lowest oral exposures to BPA in animals that were associated with adverse effects were 500,000 times higher than oral exposures in humans based on the latest biomonitoring studies (Dekant, W. and W. Volkel 2008. Human exposure to bisphenol A by biomonitoring: Methods, results and assessment of environmental exposures, Toxicology and Applied Pharmacology Volume 228, pages 114-134).

2. CR Claims:
FDA's Safety Standards for BPA Inadequate and Out of Date

False:
The FDA’s position on BPA does not differ in conclusion from the findings expressed in any of the following, which is that BPA is safe:

The European Union’s risk assessment in 2006; a review by Japan’s National Institute of Advanced Industrial Science and Technology (2007); an examination of claims of neurotoxicity by the Norwegian Scientific Committee for Food Safety (2008);  an update to the European Union’s risk assessment  (2008); an evaluation by the French Food Safety Agency (2008); a risk assessment by NSF International, a World Health Organization collaborative center (2008); a review of new data by the German Federal Institute for Risk Assessment (2008); a survey by Health Canada (2009); a risk assessment by Food Standards Australia/New Zealand (2009); two more surveys by Health Canada, one on canned powdered infant formula, the second on bottled water products (2009); a hazard assessment by California’s Environmental Protection Agency (2009); and a modeling study of BPA in humans by the German Federal Institute for Risk Assessment (2009).

3. CR Claims:
"The findings are noteworthy because they indicate the extent of potential exposure," said Dr. Urvashi Rangan, Director of Technical Policy, at Consumers Union, nonprofit publisher of Consumer Reports. "Children eating multiple servings per day of canned foods with BPA levels comparable to the ones we found in some tested products could get a dose of BPA near levels that have caused adverse effects in several animal studies. The lack of any safety margin between the levels that cause harm in animals and those that people could potentially ingest from canned foods has been inadequately addressed by the FDA to date."

Misleading/False:
Children who are of an age to eat out of cans metabolize BPA exactly the same way as adults do. When BPA is ingested, it is rapidly detoxified, first in the gastrointestinal tract (GI) and then in the liver by enzymes, which add a sugar molecule to BPA, transforming it into a water soluble BPA-glucuronide. The sugar conjugate is easily and quickly excreted in urine. The half life of BPA-glucuronide is six hours. There is a minor metabolic pathway in which some BPA is converted to a sulfate, but this is also water soluble and quickly excreted from the body (Tsukioka et al.,2004; Völkel et al., 2002, 2005).

In both of these pathways, BPA is deactivated, meaning it loses its capacity to act like an estrogen (Matthews et al., 2001; Shimizu et al., 2002; Snyder et al., 2000). This is important to note as BPA is considered to have a weak estrogenic capacity (approximately 15,000 times weaker than the strongest naturally-occurring estrogen in humans) – one of the reasons it has been dubbed an “endocrine disruptor” by environmental activists. The way orally ingested BPA is metabolized removes that capacity.

Dr. Urvashi Rangan is comparing apples with oranges. He relies on studies where animals have had BPA directly injected into their blood which means that the chemical is and not deactivated. And then he claims the same thing could happen through exposure to BPA from oral exposure. There is no evidence that this is biologically possible.

4. CR Claims:
The lack of any safety margin between the levels that cause harm in animals and those that people could potentially ingest from canned foods has been inadequately addressed by the FDA to date."

False:
There is a safety margin. The FDA has followed research conducted by the European Union, which, through a requirement to use the precautionary principle, has extremely stringent regulations on chemicals. Wolfgang Dekant, professor of toxicology at the University of Würzburg and one of the lead authors of the European Food Safety Authority risk assessment (as well as a co-author of the BPA biomonitoring study) has told STATS this year that,

“The exposure of babies to BPA is well below the tolerable levels based on the most sensitive toxicity endpoint seen in reliable animal studies [with the] inclusion of an additional safety factor of 100. Moreover, babies are exposed to a variety of other compounds with weak estrogenicity such as isoflavones from diet (higher exposures and more potent hormones compared to BPA."

Recent  research by the EPA – A.M. Calafat et al. (2009) Exposure to bisphenol A and other phensols in neonatal intensive care unit premature infants. Environmental Health Perspectives Volume 117, pages 639-644 – demonstrates that even premature babies are capable of metabolizing BPA in the same way as adults.

5. CR Claims:
BPA, which has been used for years in clear plastic bottles and food-can liners, has been restricted in Canada and some U.S. states and municipalities because of potential health effects. 

Misleading:
Here’s what Health Canada said: “The current research tells us the general public need not be concerned. In general, most Canadians are exposed to very low levels of bisphenol A, therefore, it does not pose a health risk.” Out of concern for infants, Canada labeled “toxic” under Section 64 of the Canadian Environmental Protection Act when used in food containers.

France’s health minister, Roselyne Bachelot,described the decision as irrational: “Reliable studies have concluded that baby bottles containing bisphenol-A are innocuous,” she told the National Assembly after being urged to follow Canada’s lead.

Subsequently, two studies by Health Canada showed no risk to infants from either bottles or jars. You would have to drink 1000 liters of bottled water a day to approach Canada’s provisional tolerable daily intake for the chemical.

In the U.S., a panel of physicians and medical experts in California refused to ban BPA after reviewing all the available evidence.

6. CR Claims:
Federal guidelines currently put the daily upper limit of safe exposure at 50 micrograms of BPA per kilogram of body weight. But that level is based on experiments done in the 1980s rather than hundreds of more recent animal and laboratory studies indicating that serious health risks could result from much lower doses of BPA.

False:
Based on the latest research, the European Union’s risk assessment reaffirmed the 50 micrograms of BPA per kilogram of body weight tolerable daily intake in 2006 and again in 2008. The FDA followed the EU in its recent assessment. The studies cited by Consumer Reports have been repeatedly rejected by international risk assessments for being methodologically or experimentally flawed or irrelevant. The National Institute of Environmental Health Sciences, which funded many of these studies, recently noted these failings and tightened the methodological criteria for new grant proposals.

7. CR Claims:
Several animal studies show adverse effects, such as abnormal reproductive development, at exposures of 2.4 micrograms of BPA per kilogram of body weight per day, a dose that could be reached from a person eating one or a few servings daily or an adult daily diet that includes multiple servings of canned foods containing BPA levels comparable to some of the foods Consumer Reports tested. 

False:
a) The most comprehensive study of oral ingestion using the latest biomonitoring techniques concluded that our daily exposure to BPA works out at less than one-tenth of a microgram per kilogram of body weight (Dekant, W. and W. Volkel 2008. Human exposure to bisphenol A by biomonitoring: Methods, results and assessment of environmental exposures, Toxicology and Applied Pharmacology Volume 228, pages 114-134):

“The average daily doses of bisphenol A in adults delineated by biomonitoring and supported by the exposure assessment based on concentrations of bisphenol A in the diet are more than 500-fold below the TDI set by EFSA and the US EPA reference dose (both 50 μg/kg bw/ day) suggesting that the exposure to bisphenol A does not result in a health risk to the general population. In addition, the bisphenol A exposures of the general population are also well below the daily doses of bisphenol A that sometimes have been reported to cause responses of unknown toxicological relevance in highly sensitive animal systems (20 μg/kg bw/day) (Timms et al., 2005) giving Margins-of-Exposure of 200 or more. For a comparison with human intake of other weakly estrogenic compounds, bisphenol A intake is at least 30 fold lower than that of phytoestrogens, which are more potent estrogens as compared to bisphenol A (Moors et al., 2007, Safe, 2004, Valentin-Blasini et al., 2005).”

False:
b) Once again, studies that showed adverse effects relied on the injection of BPA directly into the bloodstream. The National Toxicology Program, along with every regulator and risk assessment in the world has rejected injection-studies as a relevant method for assessing human risk from BPA as our exposure is through ingestion. :Large, statistically rigorous, multi-generational reproductive toxicity studies have failed to reproduce these effects. The latest, by the EPA, was published last week.


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