FDA Changes Course – Now Believes Bisphenol A (BPA) Poses Safety Concern

Well, after years of contending that bisphenol A (BPA) is perfectly safe, the Food and Drug Administration has reversed course. On Friday, the FDA announced that it now considers BPA to be of some concern for effects on the brain, behavior and prostrate glands of fetuses, infants and young children (consistent with the National Toxicology Program’s findings). 

But, even though the FDA now has some concern about BPA’s safety, it claims it can’t do anything. The Milwaukee Wisconsin Journal Sentinel reports that top FDA officials say that while BPA’s safety is uncertain, they are powerless to regulate it. Why? Because it is listed among some 3,000 chemicals that are “generally regarded as safe” and that designation exempts those chemicals from scrutiny.

As the FDA explains:

Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago.  This regulatory structure limits the oversight and flexibility of FDA.  Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation.  There is no requirement to notify FDA of that use. For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics.  As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations.  Furthermore, if FDA were to decide to revoke one or more approved uses, FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal.

So, FDA is going to study BPA some more. And it is looking for some legislative help so that it can regulate BPA, at least according to the officials quoted by the Milwaukee Sentinel. But that doesn’t help the rest of us very much if we are looking for ways to avoid BPA exposure, particularly if you are pregnant, or have young children.

And it isn’t very satisfying that at this late date, more than 10 years after leading scientists questioned BPA’s safety, that the FDA is reaching this decision but taking the position it can’t do anything. More stalling at the behest of the chemical industry?

The American Chemistry Council continues to proclaim that BPA is perfectly safe, because, as the ACC always says, BPA has not been proven harmful to children or adults. The FDA held a conference call on Friday for some media to discuss BPA. And while I was not invited, I avidly followed one of the journalists who was tweeting the call. And she kept tweeting statements of the ACC representative about how safe BPA was and how all the studies were flawed because they failed to account for human metabolization of BPA. When I tweeted at her to ask about the fact that infants under 3 months lack the full complement of enzymes necessary to metabolize BPA (and fetuses have none), the ACC representative completely dismissed the scientific studies. If you don’t know who the ACC is, it is an organization whose members include Monsanto, Bayer, Merck, DuPont and many others. And the FDA has been accused of being too cozy with the chemical industry lobbyists, including the chair of the FDA panel taking a $5 million donation.

And to be honest, the FDA’s reversal really annoys the heck out of me after FDA Acting Commissioner Andrew C. von Eschenbach, MD’s article, Andy’s Take on BPA from August of 2008. In his article, he stated that “with progress comes peril!” He then argued that “science creates these products and science must inform us of their risks.” So, he contended that until science showed us that BPA was unsafe, we should assume that it is safe. Which seemed like a bunch of bunk to me. If you believe that “with progress comes peril”, then it seems to me that you would take a cautious approach, and instead have science inform us that a chemical was safe before it was used.

So what can you do if you want to avoid BPA? Well, skip polycarbonate plastic and avoid canned foods and beverages. And you really might want to, particularly if you are pregnant. In a non-scientific CBS Early Show experiment, Kelly Wallace ate a sandwich made from canned tuna, and had her blood drawn. She then spent 2 days avoiding BPA, and had her blood drawn again. The first set of blood samples showed a BPA level five times higher than what is found in the average US woman. 

To avoid canned foods and beverages, go for fresh, frozen, dried or jarred in glass or a plastic other than polycarconate. Polycarbonate is in the #7 “other plastic” group. Not all #7 plastic is polycarbonate, however. If you need BPA free feeding gear for kids and babies, check out my dear friend’s website, The Soft Landing. If you need a guide, check out Z Recommends’ The ZRecs Guide for advice on BPA-free children’s products.

Health Canada Reports BPA Free Baby Bottles Leach Bisphenol A?

Last week, it was reported that Health Canada had found some allegedly bisphenol A (BPA) free baby bottles nonetheless leached BPA. Well, upon further digging, it appears that very low levels of BPA were found in fluid held in some BPA free baby bottles, but that the source may simply be BPA in “dust” from manufacturing or perhaps even the lab or some other problem. The report has numerous critics, and not just from industry. Truly, it appears that the study has significant flaws. In any event, I was going to prepare a long, detailed post but, thank god, Jennifer and Jeremy at Z Recommends already did it. So, I’m just going to link to their most awesome, detailed, incredible post digging into the story. Go read it.

And if you are tired of worrying about what is in your baby’s plastic bottles or sippy cups, you can try glass or stainless steel. Check out OrganicKidz stainless steel baby bottles, for example.

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FDA Subcommitee Harshly Critical of Draft Safety Report on Bisphenol A (BPA)

babyI recently expressed concern about whether the Food and Drug Administration’s (FDA) Subcommitee reviewing the FDA’s draft safety assessment of the use of bisphenol A (BPA) could provide a fair review.  I expressed concern because it had been revealed that Subcommittee Chairman Prof. Philbert had failed to disclose a significant donation from pro-plastics contributor Charles Gelman to the chairman’s research center at the Univ. of Michigan.  To resolve that question, the FDA Chair has issued a letter stating that he agrees with the findings of the review conducted by William McConagh a of FDA’s Office of Accountability and Integrity.  That review found that the $5,000,000 donation made by Charles Gelman and the unrestricted grant to the University of Michigan from Dow Chemical for a risk study of dioxin do not require Prof. Philbert to recuse himself but he nevertheless recommends that Prof. Philbert refrain from voting on the questions before the Board relating to BPA.


In any event, imagine my surprise to learn that the Subcommittee’s scientific peer-review report roundly criticizes the FDA’s draft BPA safety assessment.  So perhaps science isn’t for sale after all, at least with respect to the Subcommitee.


Okay, to catch you up, low level exposure to BPA has been linked to hormone disrupting effects in laboratory animals.  BPA is the key monomer of polycarbonate plastic, used for baby bottles.  BPA is also found in the epoxy resins used to line virtually all canned foods and beverages.  BPA can leach out of polycarbonate plastic and the epoxy resins and into your food.  Whether the effects seen in laboratory animals are likely to occur in humans based upon current levels of exposure is subject to much intense debate in the scientific community.  The National Toxicology Program (NTP) issued a report finding the risk a 3 on the NTP’s 5 point scale for 3 health endpoints.  The FDA has maintained that BPA is safe.


In August of this year, the FDA issued a draft report finding BPA safe.  Then, the FDA convenened a Subcommitee to review the draft report.  I thought that the Subcommitee would be, in essence a rubber stamp.


But surprise, surprise, the FDA’s Subcommitee does not agree with the draft safety assessment on BPA.  In fact, it is pretty critical of it.  It finds that the “draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment.  Specifically, the Subcommittee does not agree that the large number of non-GLP [good laboratory practice] studies should be excluded from use in the safety assessment.”  The report goes on to state “[c]oupling together the available qualitative and quantitative information (including the application of uncertainty factors) provides a sufficient scientific basis to conclude that the Margins of Sfatey defined by the FDA as ‘adequate’ are, in fact, inadequate.”


Okay, so what does that mean?


Well, what it means is that the peer reviewed assessment of the FDA’s draft report on BPA is telling the FDA that the draft report is inadequate.  The Subcommitee has particular criticisms – it finds that the FDA didn’t use enough infant formula samples and didn’t adequately account of variations among the samples.  It also finds that the FDA didn’t take into account multiple sources of BPA exposure.  But it also is particularly critical of the FDA’s wholesale discounting of studies found adequate by the NTP.  And, I think that this is most important.  The Subcommittee harshly criticizes the FDA for discounting or failing to consider scores of studies that have linked BPA to adverse health effects in animals.


Is the debate over?  No.  The Subcommitee’s report will be considered as part of a briefing on October 31, 2008.  What is likely is that more research will be approved.  And, in the interim, the FDA has issued a Statement on the release of the Subcommitee’s report, pointing out that “the present consensus among regulatory agenices in the United Sates, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”


In light of the animal studies and the conclusion from the NTP finding “some” concern for effects on the prostate, brain and behavior, you may not want to take that risk.  So, if you want to try to avoid BPA, skip polycarbonate plastic.  Lots of alternatives exist – and don’t cost any more than polycarbonate plastic.  So you can play it safe.  Also, instead of canned foods and beverages, go for jarred, fresh, frozen or dried.

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NTP Issues Final Report – Bisphenol A or BPA Exposures May Harm Babies and Kids

Finally, the US Department of Health and Human Services’ National Toxicology Program (“NTP”) has issued its final report on bisphenol A (BPA).  And the NTP expressed some concern about the potential health effects associated with BPA exposuers at the current levels to which we are exposed.

For background, tThe NTP uses a 5 point scale of concern – negligible, minimal, some, concern and serious.  The NTP’s final report on BPA found:

  • The NTP has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to BPA.

  • The NTP has minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants and children at current human exposures to BPA.

  • The NTP has negligible concern that exposure of pregnant women to BPA will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring.

  • The NTP has negligible concern that exposure to BPA will cause reproductive effects in non-occupationally exposed adults and minimal concern for workers exposed to higher levels in occupational settings.

In connection with the report, NTP Associate Director John Bucher, Ph.D., stated “There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects.  But we have concluded that the possibility that BPA may affect human development cannot be dismissed.” 


How should consumers react and what should they do?  Well, the NTP doesn’t provide much advice.  CERHR Director Michael Shelby, Ph.D., stated “if parents are concerned, they can make the personal choice to reduce exposures of their infants and children to BPA.”


Will this end the debate?  No.  In fact, I recently go into a debate on the subject after Mommy Myth Buster posted that BPA being harmful was a myth.  I happen to disagree that it is a myth.  I don’t think uncertainty makes something a myth.  That being said, I do think, however, that it is clear that the science on the issue is uncertain.  The low dose animal studies are just that, animal studies.  Making those studies relevant to humans involves analysis and assumptions.  And the animal studies are not necessarily relevant to humans – rodents, for example, process BPA differently so whether the adverse health effects seen in rodents apply to humans is not yet answered. 


But reports continue to document adverse health effects associated with BPA exposure.  Just this week, scientists at the Yale School of Medicine have found that “exposure to low-dose BPA may have widespread effects on brain structure and function.”  The study found that low dose BPA exposure may lead to disruption in memory and learning, and depression.  Or, as TreeHugger put it – “BPA may make you stupid and depressed.”  What is important about this study is that it involved monkeys – and monkeys process BPA more like humans, as opposed to rodents.  This is the first time BPA has been linked to health problems in primates. 


The study’s authors suggeste that the EPA should lower its current acceptable level for human exposure to BPA.


The FDA continues to maintain that BPA is safe.  The FDA recently issued its draft report declaring BPA to be safe.  Specifically, the FDA’s draft report states the “FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”  The draft report was issued in advanced of a meeting scheduled for September 16 – methinks the meeting will be very interesting . . .


And the industry?  The American Chemistry Council responded to the NTP’s report with the statement that “There is no direct evidence that exposure to bisphenol A adversely affects human reproduction or development.” 


So, what can a parent do if the experts can’t decide?  The health effects from very small dosages that only recently could be detected are just now being understood.  Recent research has shown harmful effects in animals at low levels (levels consistent with human exposure).  Emerging, substantial evidence indicates that BPA can harm laboratory animals at concentrations below the daily levels to which most of us are already exposed.  In fact, the Chapel Hill panel’s consensus statement evaluated the strength of data from more than 700 BPA studies and labeled as “confident” its assessment that BPA at low doses has had a negative effect on experimental animals.  The panel concluded that BPA exposure in the womb can permanently alter genes of animals, impair organ function in was that persist into adulthood, and trigger brain, behavioral and reproductive effects, including diminished sperm production. 


I think that with the NTP finding “some concern” – or a 3 on the NTP’s 5 point scale – caution is in order.  I think it is prudent to reduce exposure to BPA for pregnant women or women trying to get pregnant, babies and young children.  With so many alternatives on the market, why not minimize the risk?  As my mom use to safe, better safe than sorry.

 As Scott M. Belcher, PhD, Associate Professor and University of Cincinnati and lead researcher in BPA says, “You have to estimate the relative benefit and understand the possible risks, or the fact that the risk is unclear because the science is lacking.  There are many “maybes” in the equation.  But what is known is that BPA has estrogen-like activity.”  His conclusion?  “Based on my knowledge of the scientific data, there is a reason for caution.  I have made a decision for myself not to use polycarbonate plastic water bottles.” 

 


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PLASTICS/BPA: Safe to use? baby bottles, sippy cups, plastic wrap, Tupperware, melamine?

Updated May 13, 2008, Updated May 21, 2008, Update December 6, 2008


It seems like everybody is just confused about plastics for formula, breast milk, and food storage.  PVC, phthalates, BPA – what the heck should you use?  And how do you figure it out?  I’ve gotten tons of questions – is melamine safe to use?  Can you use cling type wraps?  What about Tupperware?  Which baby bottles are safe?  Can I use the Beaba Babycook?


You don’t want phthalates in your food.  Phthalates leach from polyvinyl chloride.  You don’t want bisphenol A in your food.  BPA leaches from polycarbonate plastic (and also the epoxy resins used to line virtually all canned food and beverages).  But what is safe to use? 


First – a plastic primer.  The resin identification codes are #1 through #7.  Not all products have the resin identification code (often referred to as the recycling symbol).  Why?  Because it is used primarily on disposable and single use items – those items intended to be recycled.  And, just keep in mind that it is an identification code to make sorting plastic easier – just because there is an identification code on your plastic does not mean that your jurisdiction actually will recycle it.


Recycling Logos


Okay, so the plastic resin identification codes are: 


#1 is polyethylene terephthalate.  Considered a safer plastic, although some reports of leaching antimony after long storage.  And, although the word “phthalate” appears in the name, this plastic is NOT know for leaching the phthalates used as plasticizers in PVC.


#2 is high density polyethylene.


#3 is Polyvinyl chloride (PVC).  Avoid.


#4 is low density polyethylene.


#5 is polypropylene.


#6 is polystyrene.  Avoid.


#7 is other (not one of #1 – #6).  Often polycarbonate, although also includes the new bioplastics.  Avoid polycarbonate.


 Here are Smart Mama’s Simple Steps for most common items.


For baby bottles, skip polycarbonate plastic to avoid leaching of bisphenol A (BPA).  Here are some options


For sippy cups, skip polycarbonate plastic to avoid leaching of bisphenol A (BPA).  Here are some options.


For pacifiers, use silicone or natural rubber.  Keep in mind that the guard may be made of polycarbonate plastic.  Exposure to BPA from the guard is probably a lower risk than exposure from food storage containers since the baby’s mouth may not touch it, or may not touch it that much.  However, there is probably some leaching from the guard through saliva contact.  There are options if you want to avoid BPA-containing plastic pacifier guards altogether.


For sandwich bags, most of them are low density polyethyelene (LDPE – #4) and considered to be made from a “safer” plastic.  However, they are not as eco-friendly as using a re-usable container (such as stainless steel) or using butcher paper.


For plastic wraps, some are made of PVC (#3).  If they are made of PVC, they may leach phthalates.  However, many plastic wraps intended for in home use on the market today are not made of PVC.  Glad Cling Wrap, Handi-Wrap and Saran Premium Wrap are not made of PVC but are made of low density polyethylene (LDPE).  It is my understanding that you are likely to find PVC containing plastic wraps in discount, no name wraps and commercial wraps. 


Tupperware, Rubbermaid and others have some products that are polycarbonate and many that are not.  Tupperware’s list of of its products and the plastics from which they are made can be found here.  Rubbermaid has a list of products that contain BPA and those that do not contain BPA with pictures so that it is easy to use.  However, for food storage, it would be best to switch to glass or ceramic.  If you use glass, keep in mind that some of the painted on decals can have lead, and if you use ceramic, make sure it is free of lead.


What about the so called safer plastic, polypropylene (#5)? Recent news reports stated that #5 plastic may leach potentially harmful chemicals.  A team of researchers found that quaternary ammonium biocides and oleamide were leaching for #5 plastic and interfering with their experiments.  The results are preliminary – the researchers weren’t studying leaching but discovered the leaching inadvertently.  Further testing will have to verify the results.


Is melamine safe?  It appears to be.  The melamine used in dinnerware is made from melamine being combined with formaldehyde to produce melamine resin.  It is a very durable thermoset plastic.  However, there are studies showing leaching of formaldehyde and melamine at extremely low levels.  However, if you are trying to exposure to chemicals, you may also want to skip melamine.  Also, some decals used have been found to have lead and cadmium present.  Also, keep in mind that the issue with melamine in milk products such as infant formula and pet food involved the ingestion of granular melamine.


What about the 5 gallon water bottles, such as for Arrowhead water?  They are typically polycarbonate plastic.  You might want to choose another option for water, such as glass.


What about the Beaba Babycook?  After many emails, we have confirmation from the manufacturer that the Beaba Babycook is NOT made of polycarbonate plastic.

Finally, a personal note, I’ve switched to undecorated glass and stainless steel as much as I can.  As I replace broken or lost items, I’m buying glass and stainless steel because I’m trying to reduce our plastic consumption and because, well, I’m not so sure there really is a “safer” plastic.

 

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BPA: What is Bisphenol A doing in baby bottles and why is it a problem?

You may have read news reports about the potential dangers of certain plastic baby bottles.  The concern stems from Bisphenol A, which is present in polycarbonate plastic.  Many baby bottles are made from polycarbonate plastic, as are countless other consumer items.  Polycarbonate plastic is widely used plastic.  It is clear, lightweight, heat resistant, and shatter resistant.  It is used in a wide variety of applications, many of them involving direct contact with foods and beverages, including baby bottles, reusable sports water bottles, food storage containers, and tableware.  


Plastics are like very long trains made up of identical railroad cars.  The technical explanation is that most plastics are polymers, or are long molecules (the very long train) made up of many repetitions of a basic molecule called the monomer (the railroad car).  Bisphenol A is the basic monomer of polycarbonate plastic.  Bisphenol A (BPA) is a synthetic chemical compound used in a wide range of consumer products.  It has found its way into the bodies of most of us.  A study in the US found that 95% of people tested had been exposed to BPA.


Bottle FeedingUnder certain conditions, BPA leaches out of the polycarbonate and into the food or drink.  What are those conditions?  Well, it is uncertain, but it appears that leaching occurs with everyday use, and is much higher when the bottles are scratched or worn.  It also appears that leaching is much worse when the bottles are heated.


Exposure to BPA may cause health effects.  The safety of BPA is being hotly debated right now.  The U.S. Food and Drug Administration and the plastic industry maintain the BPA is safe at the levels to which most consumers are exposed.


However, some research scientists have been increasingly warning consumers about potential dangers.  BPA has been shown to be an endocrine disruptor and to simulate the action of the human hormone estrogen.  Early life exposure may cause stimulate certain cancers and may cause genetic damage.


The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction convened an expert panel to evaluate BPA.  The Panel’s final report is scheduled to be published in Fall 2007, but the draft meeting summary identifies the following conclusions:


For pregnant women & fetuses:




  • Some concern the exposure to BPA in utero causes neural and behavioral effects


  • Minimal concern that exposure to BPA in utero causes effects on the prostrate and accelerations in puberty


  • Negligible concern that exposure to BPA in utero produces birth defects and malformations

For infants & children:



  • Some concern that exposure to BPA causes neural and behavioral effects

  • Minimal concern that exposure to BPA potentially causes accelerations in puberty

For adults:




  • Negligible concern for adverse reproductive effects following exposures in general population


  • Minimal concern for highly exposed subgroups (e.g., occupational exposures)

Concern is rated as follows:  negligible, minimal, some, concern and severe.

Part of the problem is that there have been no human studies of BPA exposure.  More than 150 studies have found health effects in animals exposed to low doses.  However, scientists have reached different conclusions about whether BPA is safe in part because of metabolic differences between mice and humans and uncertainty in the amounts to which people are actually exposed.  Japan and the European Union’s Food Safety Authority recently reaffirmed BPA’s safety, criticizing the methodology of rodent/BPA studies as unreliable.  That’s really the root of the difference – these scientists haven’t agreed on how to translate the animal studies into human effects.


The Panel’s conclusions have been criticized by other leading experts.  In a consensus statement published in Reproductive Toxicology, a group of 38 scientists, including 4 from federal health agencies, concluded that people are exposed to levels of BPA exceeding those levels that harm lab animals, and that infants and fetuses are the most vulnerable.  This group of scientists reached these conclusions after reviewing about 700 studies.  Jerrold Heindel, a scientist with the National Institute of Environmental Health Sciences who organized a meeting last fall to begin drafting the statement, said even though there have been no human studies of BPA, there is now so much animal data that the 38 experts believe that human damage is likely.  “We know what doses the animals were given, and when we look at humans, we see blood levels within that range or actually higher, which is a cause of concern and should stimulate more human research,” he said.


In the statement, the 38 scientists say they are confident that BPA, which mimics the female hormone estrogen, alters cells to switch genes on and off, programming a fetus or child for reproductive disorders later in life, and that the levels that harm lab animals “are well within the range of … BPA levels observed in human fetal blood.”


They concluded that “early life exposure … may result in persistent adverse effects in humans.”