Congressional Panel Investigating Bisphenol A in Infant Formula Investigates the Sale of Science

There have been some very interesting developments in connection with the Congressional investigation into the use of bisphenol A (“BPA”) in infant and baby products.  I’ve been paying attention to the investigation to see what information is developed.  But the investigation seems to have morphed since its initial launch.  I don’t know if anything will come of it, but it seems like that at least somebody is interested in determining whether science has been for sale in connection with assessing the safety of chemicals.  The panel started its inquiry into the use of BPA-containing epoxy resin in infant formula containers.  But the most recent letters issued by the Congressional panel are broader in scope.  The Committee on Energy and Commerce issued letters to the U.S. Environmental Protection Agency (“EPA”), a law firm and a scientific consulting firm inquiriing into whether, basically, science has been for sale.

The letter to the consulting firm, the Weinberg Group, is most entertaining.  It uses the publicity on the Weinberg Group’s website and asks for the information to support the assertions.  The very first question asks for the information associated with the Weinberg Group’s assertion that it worked to delay the cancellation of a new drug allowing for “10 additional years of sales prior to the ultimate cancellation of the drug.”

The letter to the EPA is also entertaining.  It questions the EPA’s recent dismissal of Dr. Deborah Rice from the external peer review panel reviewing the draft health risk assessment for decabromobipheny ether (deca PBDE) for an apparent conflict of interest and an “appearance of a lack of impartiality.”  It notes that the American Chemistry Council objected to Dr. Rice after she testified to th Main legislature on the human health risks associated with deca PBDE as a scientist employed by the Maine Department of Health and Human Services.  It points out that the ACC’s objection to Dr. Rice seems to suggest that scientific expertise with regard to a particular chemical and its human health effects is the basis for the disqualification, a conclusion that the Congressional committee says “does not seem sensible on its face.”  The letter then goes on to ask about nine different individuals who are sitting or sat on various panels while being in more compromising positions. 

The responses of the Weinberg Group and the EPA should be quite entertaining. 

But I think what is most frightening is the U.S. Food and Drug Administration’s response to the Congressional inquiry.  The panel had asked the FDA about certain information regarind the use of BPA in epoxy-based enamels used to line infant formula metal cans.   Why are metal cans lined?  Metal cans require a lining to prevent interaction between the food and the metal can, especially those metal cans that undergo heat treatment to ensure commercial sterility. 

For some background, the Environmental Working Group (“EWG”) investigated the potential leaching of BPA into infant formula, and found BPA present in formula.  Liquid formulas in metal cans had higher concentrations of BPA present than powdered formula.  In fact, the EWG concluded that liquid formulas have the potential to leach at a rate 8 to 20 times higher than powdered formula in metal cans.

The EWG’s study tested 6 liquid formulas.  The FDA has also tested liquid formulas.  Both studies found an average of 5 parts per billion BPA, with four samples above 10 ppb.  The FDA has approved the use of epoxy resins containing BPA in food contact items such as formula.  The FDA maintains that the use of BPA-containing enamels for infant formula containers is safe.  In its response, the FDA stated “FDA has compared the ‘no observed effect’ levels of the data reviewed to the estimated daily intake values and considers that an adequate margin of exposure exists for the conclusion of reasonable certainty of no harm under the intended conditions of use.”  But, the response to the Congressional inquiry stated that FDA’s determination is based on two studies, both of which were reportedly funded by the American Plastics Council, and both of which have been criticized.  The studies have been criticized because one was never published in a peer reviewed journal and the other study used Charles River Sprague-Dawley rats, which some studies have shown only respond to estrogen at high doses.  This study did not use any positive control, which means that it cannot be determined whether the study was capable of finding any health effects from BPA.  The FDA’s letter relies on the conclusion that 7 ug/infant/day is safe.  But, according to the EWG “a baby of average size would exceed FDA’s worst-case dose if he or she drank more than 2.5 bottles (20 ounces) contaminated with BPA at the maximum levels measured in the 20 total samples tested to date in FDA and EWG testing programs.”  The EWG also criticized the BPA migration study cited by the FDA.  The BPA migration study used a level of detection of 100 ppb, a level of detection too high to detect the low levels of BPA leaching, and also well above the level of detection used by the FDA in other migration studies.

It is clear that infant formula containers can leach BPA into infant formula, with liquid formulas having a higher rate of leaching than powdered formulas.  Whether the rate of leaching of BPA results in a risk of harm is subject to debate.  Over a 100 published animal studies indicate adverse health effects at low levels, especially in infants.  Many BPA experts believe that the adverse health effects in animals at low doses of BPA, and that there is no reason to think that such effects would not also occur in humans. 

So what’s a concerned parent to do?  Choose glass over metal contains for infant formula and, if using formula (breast milk is best) powdered infant formula over liquid infant formula.

Getting lead out – safe lead levels in children’s toys & the dirty history of lead in paint

Is there a safe level of lead in children’s toys?  Perhaps not.  Recent studies suggest that the current standard for blood lead levels of 10 micrograms per deciliter of blood is too high.  The CDC and the EPA have both issue statements that no level of lead in the blood is safe, although the standard has not yet been lowered. 

Dr. Bruce Lanphear, Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center said in an interview reported in the Baltimore Sun that a study he published last year showed that children older than 4 with lead levels as low as 2 micrograms per deciliter had a four fold risk of having attention-deficit hyperactivity disorder as compared to children older than 4 with lead levels less than 1 microgram per deciliter.  Other studies have shown similar results.  For example, one study reported in the New England Journal of Medicine showed a significant drop in IQ at levels below 10 ug/dL. 

Blood lead levels correspond with the levels of lead in the individual’s environment.  If no blood lead level is safe, then lead should be eliminated as much as possible from all sources.  Lead in children’s toys isn’t the only source of lead.  Lead in our houses is probably the biggest source of exposure.  The U.S. Department of Housing and Urban Development estimates that 25% of our nation’s housing contains significant lead based paint hazards. 

What is alarming is that the US didn’t regulate lead in paint until 1978 but the hazards of lead in paint were known much earlier.  In 1904, J. Lockhart Gibson was one of the first English-speaking authors to link directly lead based paint to childhood lead poisoning.  In 1905, he wrote, “The use of lead paint within the reach of children should be prohibited by law.”  Others made similar links in published literature, including 2 Americans in 1914.  Kenneth Blackfan and Henry Thomas reported a boy who died of lead poisoning after ingesting leaded paint on his crib railing.  With this information, other countries banned or restricted lead in residential paints beginning in 1909 with France, Belgium and Austria to Great Britain, Sweden and Belgium in 1926, among many others. 

The US didn’t act, even in the face of mounting evidence, because of the strength of lobbying by the lead paint industry.  In fact, the lead paint industry’s advertising in the first half of the 20th century aggressively promoted lead paint for interior use, and focused on children.  Some of the advertising pictures are just frightening – several children’s items and the slogan “lead takes part in many games.”  The lead paint industry aggressively challenged the scientific reports, and dismissed the scientific evidence.  So we are left with a toxic legacy. 

Okay, so this isn’t information you can use to reduce exposure.  And that is what this website is supposed to be about.  But I’ve been following the progress of AB 1108, a bill in California that would ban/limit phthalates in products intended for use by children under the age of 3 years.  The bill has been passed out of the California Legislature and is awaiting the Governor’s signature, but he has threatened to veto it.  The lobby against the bill cites scientific surveys that show how safe phthalates are . . .and I keep thinking of the history about lead in paint.

BPA: What are simple steps to reduce my baby’s exposure to BPA?

Updated May 9, 2008 

Simple Step #1:  Switch to a BPA-free bottle.  You are looking for a bottle that does not have any components that are made of polycarbonate plastic.  Try the list here

Simple Step #2:  Minimize leaching from polycarbonate plastic bottles.  If you can’t switch to BPA free bottles, then minimize leaching of BPA from polycarbonate baby bottles: 

  • Discard old, worn or scratched polycarbonate baby bottles or sippy cups.  Leaching occurs more readily from worn plastic.
  • Heat food and drinks outside of the plastic and transfer when cool enough to eat or drink.  Heat appears to increase the rate of leaching.
  • Wash bottles and sippy cups by hand with a mild dishwashing soap, such as castile soap, instead of a harsh detergent or placing them in the dishwasher

Simple Step #3Check your infant formula.  The packaging for infant formulas contains BPA, and the BPA leaches into the formula.  Canned prepared liquid infant formulas have the highest rate of leaching.  If you are using prepared liquid infant formula, choose the ready-to-feed formula from Similac in quart-size plastic containers.  These are free of BPA.  If you are using powdered infant formula, the single serving powder packets by Enfamil and Similac are BPA-free.  This option can get expensive, however.  So, choose an infant formula with the smallest amount of surface area coated with BPA on the interior of the can.  According to information retrieved from the manufacturers’ websites, calls to customer service, and the letters submitted to the Congressional Committee investigating BPA in infant formula, Nature’s One infant powdered formula, Baby’s Only organic, only has the easy open metal top coated with a resin containing BPA.  The Earth’s Best also only has the top lined with BPA (although Earth’s Best apparently gave the EWG different information). 

Simple Step #4:  Choose sippy cups and other food storage and serving pieces that are not made of polycarbonate plastic. 

Simple Step #5:  Choose soups, milk and soy milk packaged in cardboard “brick” cartons (BPA is used in a resin to line cans) 

Simple Step #6:  Choose fresh, frozen, dried or glass jarred over canned foods.  Canned food may be the major source of exposure for most people.  The Environmental Working Group released a report in March 2007 that reported results of its testing of certain canned foods.  The study found that: 

  • Cans of chicken soup, infant formula, and ravioli had the highest BPA levels.
  • 1 in 3 cans of infant formula had BPA levels “200 times the government’s traditional safe level of exposure for industrial chemicals.”
  • Overall, 1 in 10 cans tested had high levels of BPA.

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.”