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EWG Testifies in Pa. on BPA

EWG Testifies in Pa. on BPA

Wednesday, February 3, 2010

Testimony of EWG's Richard Wiles before the General Assembly of Pennsylvania regarding BPA in children's products.

January 14, 2010

Chairman Preston, Members of the Committee, thank you for the opportunity to testify today in support of House Bill 221, legislation to prohibit the manufacture, sale or distribution of certain child care articles containing bisphenol-A, or BPA, in Pennsylvania.

My name is Richard Wiles, and I am the Senior Vice President for Policy and Communications at the Environmental Working Group (EWG), a non-profit environmental research and advocacy organization that uses the power of information to protect public health and the environment. EWG has offices in Washington, DC, Oakland, California, and Ames, Iowa.

EWG produces original research and analyses to help educate the public about the hazards of toxic chemicals to human health and the environment. It is vitally important that we take steps to ensure that chemicals and the products in our stores and homes are safe for our children.

The federal Centers for Disease Control and Prevention (CDC) has detected BPA in 93 percent of people age 6 and older, confirming that there are daily, sustained exposures among the general public (Calafat et al. 2008). In December 2009, EWG published the results of its ground-breaking analysis that for the first time detected BPA in the umbilical cord blood of American children, in this case in ten minority babies.

There is little doubt that BPA contaminates nearly every newborn, toddler and young child in Pennsylvania at levels that very likely pose risks to their health and wellbeing.

Children ingest bisphenol-A when it leaches into drinks from the clear polycarbonate plastics used to make baby bottles, sippy cups, toys and other products. Infant formula and foods are also contaminated with BPA, which leaches from the plastic linings of metal food cans. Studies show that babies are exposed to BPA at levels above those that cause serious adverse effects in laboratory studies, including birth defects of the male and female reproductive systems (EWG 2007). BPA has been found in breast milk, amniotic fluid and cord blood, indicating exposure to the developing fetus and newborn (NTP 2008).

States Must Take The Lead:

States need to take action against BPA because the federal chemical regulatory process is broken. There are roughly 82,000 chemicals in EPA's chemical inventory. In the past 34 years under the federal Toxic Substances Control Act, the EPA has regulated just five of these chemicals.

This broken law has produced situations like that with BPA, where the preponderance of the evidence shows potential for serious harm to the most vulnerable members of society -- children and unborn babies -- yet the federal government remains paralyzed and unable to act.

For ten years, the National Institutes of Health (NIH), the National Institute of Environmental Health Sciences (NIEHS), the National Toxicology Program (NTP), the Center for the Evaluation of Risks to Human reproduction (CERHR), the EPA, the FDA and the CDC have funded studies, conducted analyzes, published papers, convened conferences, and issued press releases about the myriad hazards of Bisphenol-A.

They have spent millions of dollars and thousands of man-hours documenting the hazards of BPA, but one thing that they have not done is take any action to protect the public health.

Instead we have surrendered our public health protections to Walmart and a few other select retailers who have stood up to announce that they will not sell baby bottles made with BPA. We strongly support these actions by the nation's retailers, but Walmart is no substitute for a freely elected government or actions by the State of Pennsylvania to protect its citizens.

BPA - The Risk to Our Children:

There is a broad and growing consensus within the scientific and public health community that BPA presents a serious threat to our children's health and that exposures should be avoided whenever possible.

In over 600 peer-reviewed studies in animals, BPA has been shown to cause chromosomal and reproductive system abnormalities, impaired brain function, cancer, cardiovascular system damage, early puberty and obesity (NTP 2008).

The problem is that in the real world people have no way to understand the hazards presented by BPA or any other chemical. The average citizen doesn't follow decisions of the Endocrine Society, or the American Medical Association, or the Massachusetts Department of Public Health, the Canadian government or the National Institutes of Health.

If they did, they would know that all of these authoritative, independent organizations have expressed serious concerns about BPA or urged pregnant women, infants and children to limit contact with the chemical. Government, in this case state government, must respond to the resounding chorus of concern that BPA is a real threat to public health.

In 2007, an independent panel funded by the National Institutes of Health (NIH), made up of 38 BPA experts from around the world, expressed grave concerns that human exposures are already at or above the levels that cause harm in animal studies (vom Saal et al. 2007).

In April 2008, Canada banned BPA from baby bottles and sippy cups and pledged to develop restrictions on BPA's use in infant formula cans. In supporting the ban, Canadian health officials noted:

"There is evidence that low-level exposure to BPA, particularly at sensitive life cycle stages, may lead to permanent alterations in hormonal, developmental or reproductive capacity." [emphasis added]

In September 2008, a division of NIH, the National Toxicology Program (NTP), issued its final report officially expressing "some concern" about BPA's "effects on development of the prostate gland and brain and for behavioral effects in fetuses, infants and children" (NTP 2008). "Some concern" is the mid-point of five levels of concern. It is the same level of concern that the NTP determined was appropriate for fetal exposures to amphetamines.

If we had amphetamines leaching from sippy cups and baby bottles into infant formula, I'm sure we would have no trouble passing a bill to ban them.

In June 2009, the independent Endocrine Society, the largest, oldest, and most authoritative scientific and medical society on the human endocrine, or hormonal, system, issued a statement calling for "regulation seeking to decrease human exposure to the many endocrine-disrupting agents" and specifically cited BPA as one of the chemicals of concern (Diamanti-Kandarakis 2009).

According to the Endocrine Society, "even infinitesimally low levels of exposure - indeed, any level of exposure at all - may cause endocrine or reproductive abnormalities… particularly if exposure occurs during a critical developmental window. Surprisingly, low doses may even exert more potent effects than higher doses" (Diamanti-Kandarakis 2009).

In July 2009, the Massachusetts Department of Public Health took the extraordinary step of publishing an official guidance on how to avoid BPA, titled, "How to Protect Your Baby from BPA". According to the agency, "Possible health effects include, but are not limited to: changes in the infant's developing nervous system, such as thyroid function and brain growth; changes in behavioral development, such as hyperactivity; and changes in the normal development of the prostate gland. (MA DPH 2009).

In November 2009, the American Medical Association's Board of Delegates resolved to work with the federal government to minimize the public's exposure to BPA and other endocrine-disrupting chemicals.

And finally, legislation banning BPA from baby bottles, sippy cups, and other products intended for children have been passed in Minnesota and Connecticut.

FDA Re-review:

A major reason that BPA remains with us is the historic corruption of the science review process applied to the chemical.

For most of the past decade, industry influence has twisted decision-making on BPA at NIH and its relevant sub-agencies, as well as the FDA. While conflicts of interest at the NIEHS and NTP have been largely resolved, the FDA process remains in limbo and the outcome of current deliberations is uncertain. We hope that ongoing reevaluation eliminates clearly identified biases and ethically marginal practices, but the stakes are too high to rely on a battered FDA to completely reverse past decisions.

States need to act.

From 2001 trough 2008, Bush Administration bureaucrats oversaw a business-as-usual industry infiltration and corruption of the government science bureaucracy in regards to BPA, a situation that has only recently begun to be corrected.

Between 2003-2006, an industry consulting firm, Sciences International, managed and staffed the government health agency, the Center for Evaluation of Risks to Human Reproduction (CERHR) that conducted the first formal government BPA toxicity assessment.

In December, 2006, CERHR published its advisory panel report finding that BPA is safe.

In early 2007, EWG discovered that during the conduct of the BPA review, Sciences International simultaneously had done business with a number of chemical industry clients, including major manufacturers of BPA, Dow Chemical and BASF (Cone 2007).

On February 28, 2007, the House Oversight and Government Reform Committee launched an investigation of the conflict of interest policies of the National Institutes of Environmental Health Sciences (NIEHS), the NIH agency responsible for hiring SI to manage CERHR and conduct the BPA review. Rep. Henry Waxman and Senator Barbara Boxer requested that the Director of NIEHS, Dr. David Schwartz, provide information on potential conflicts of interest involving Sciences International.

On April 13, 2007, NIEHS fired Sciences International due to apparent conflicts of interest, but the NIEHS BPA advisory panel continued to rely upon the same draft expert panel report that was prepared by SI, despite concerns raised by many independent scientists. In June of 2007, CERHR published another draft BPA hazard assessment based on the flawed science review conducted by industry contractor SI. (Although the FDA has committed to a re-review, this 2007 science review remains the core government science base for BPA. It was only in December 2009 that the Obama FDA, under pressure from health advocates, took the steps needed to ensure that the complete science base will be considered in its reassessment of BPA toxicity.)

In February 2008, under pressure from yet another congressional committee, the House Energy and Commerce Committee, the FDA revealed that its claim that BPA exposures do not pose a health concern was based on two studies that were sponsored by the American Plastics Council, the same studies cited by SI and CERHR in their review. One of these studies has been widely criticized by BPA experts for its fatal design flaws. The other study has not been made available to the public and has not been published in a peer-reviewed journal to date.

In the fall of 2008, the FDA's independent Science Advisory Board slammed the FDA's assessment as "inadequate" for "failing to articulate reasonable and appropriate scientific support" for the data used in the assessment (FDA Science Advisory Board 2008).

The following are a few sample quotes from the Science Board review:

The draft FDA exposure assessment...lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples." (pg. 3) "[FDA] did not adequately account for variability in potential exposures, which the invited Panel noted could be very large." (pg. 5)

"The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment." (pg. 4)

"Coupling together the available qualitative and quantitative information...provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as "adequate" are, in fact, inadequate." (pg. 4)

This harsh rebuke, however, did not deter FDA bureaucrats from continuing to rely on the debunked review and to persist with their inappropriate conversations and meetings with industry BPA lobbyists.

A 2009 investigation by the Milwaukee Journal Sentinel uncovered highly inappropriate e-mail conversations between the lead FDA bureaucrat for BPA, Dr. Michael Cheeseman, and chemical industry lobbyist and architect of the BPA defense, Steven Hentges. During these exchanges Cheeseman asked for Hentges' advice on, among other things, how the FDA could debunk studies showing BPA causes miscarriages in workers who were exposed to it, even before the studies were published (Kissinger, Rust 2009).

The Obama administration has pledged to clean up this process, but Cheeseman remains in charge of the BPA assessment within the FDA. At this point,all the Obama FDA has managed to do is to delay the review. This may be a positive indication that the new FDA plans to take a careful look at all the science of BPA, but the final outcome remains to be seen.

In the meantime, our children remain the guinea pigs in a giant experiment with BPA.

Conclusion:

Studies consistently find BPA leaching from plastic bottles into liquids at levels ranging from below 1 part per billion for liquids at room temperature, up to nearly 8 parts per billion when the bottle is filled with liquid at boiling temperature (Hoa et al. 2008, EWG 2007). BPA wasdetected in 87 percent of samples of liquid formula at a range from 1 to 17 parts per billion (Cao 2008, Biles 1997, EWG 2007). At a typical level of about five parts per billion in formula, EWG analyses show that most infants fed ready-to-feed liquid formula would be exposed to approximately 1/5th the levels of BPA that have been linked to altered testosterone levels, neurodevelopmental problems, and other permanent damage to male and female reproductive systems (EWG 2007, Howdeshell et al. 1999, Honma et al. 2002). The combination of BPA contamination in liquid formula and baby bottles and its pervasiveness in biomonitoring puts our children at risk for reproductive and developmental damage (EWG 2007).

House Bill 221 is a commonsense, precautionary bill that would help fill the gaping holes in our federal health protection system. It would protect all of Pennsylvania's children from a chemical that is known to pose serious health risks. We urge you to swiftly pass and implement House Bill 221.

Thank you again for the opportunity to testify before this Committee.

References:

Biles JE, McNeal T.P., Begley T.H. 1997. FDA. Determination of bisphenol A migrating from epoxy can coatings to infant formula liquid concentrates. . J Agric Food Chem 45: 4697-700.

Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. 2008. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Environ Health Perspect. 2008 Jan;116(1):39-44.

Canada. 2008. Bisphenol Fact Sheet: Health Canada, Environment Canada. Available: http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/bisphenol-a_fs-fr_e.html [Accessed 2008].

Cao XL, Dufresne G, Belisle S, Clement G, Falicki M, Beraldin F, et al. 2008. Levels of bisphenol A in canned liquid infant formula products in Canada and dietary intake estimates. J Agric Food Chem 10(56(17)): 7919-24

Cone, Marla. 2007. The work of a Federal Risk-Assessment Center is Guided by a Company with Manufacturing Ties, Some Scientists See Bias. Los Angeles Times, Los Angeles. March 4, 2007.

Diamanti-Kandarakis E et al. 2009 Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocrine Reviews 30(4):293-342

EWG (Environmental Working Group). 2007. Toxic Plastics Chemical in Infant Formula. An analysis of bottle-fed infants' exposures to BPA. Available: http://www.ewg.org/reports/bpaformula. [Accessed 2009]

EWG (Environmental Working Group). 2008. BPA Timeline. Available: http://www.ewg.org/reports/bpatimeline [Accessed 2008]

FDA Science Board. 2008. Scientific Peer-Review of the Draft Assessment of Bisphenol A for use in Food Contact Applications: FDA Science Board, BPA subcommittee. Available: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-05.pdf [Accessed 2008].

Hoa HL, Carlson EM, Chua JP, Belcher SM. 2007. Bisphenol A is released from polycarbonate drinking bottles and mimics the neurotoxic actions of estrogen in developing cerebellar neurons. Toxicology Letters. doi:10.1016/j.toxlet.2007.11.001.

Honma S, Suzuki, A., Buchanan, D.L., Katsu, Y., Watanabe, H., Iguchi, T. 2002. Low dose effect of in utero exposure to bisphenol A and diethylstilbestrol on female mouse reproduction. Reprod Toxicol 16(2): 117-22.

Howdeshell KL, Hotchkiss AK, Thayer KA, Vandenbergh JG, vom Saal FS. 1999. Exposure to bisphenol A advances puberty. Nature 401(6755): 763-4.

Kissinger, M., Rust, S. 2009. Maker acknowledges BPA worries: Sunoco refusing to sell compound for kids' products. Milwaukee Journal Sentinel March 12,2009. Available: http://www.jsonline.com/watchdog/watchdogreports/41186522.html [Accessed2009].

Kissinger, M., Rust, S. 2009. BPA industry seeks to polish image. Milwaukee Journal Sentinel May 29, 2009. Available: http://www.jsonline.com/watchdog/watchdogreports/46510647.html [Accessed2009].

Lang IA, Galloway TS, Scarlett A, Henley WE, Depledge M, Wallace RB, et al. 2008. Association of Urinary Bisphenol A Concentration with medical disorders and laboratory abnormalities in adults. JAMA 300(11): 1303-10

Massachusetts Department of Public Health; Environmental Toxicology Program. 2009. How to Protect Your Baby for BPA (Bisphenol A). Boston, MA.Available: http://www.mass.gov/dph/environmental_health [Accessed 2009].

NTP (National Toxicology Program). 2008. The NTP-CERHR monograph on bisphenol A. Research Triangle Park, NC. Available:http://www.cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf [Accessed 2008].

vom Saal FS, Akingbemi BT, Belcher SM, Birnbaum LS, Crain DA, Eriksen M, Farabollini F, Guillette LJ Jr, Hauser R, Heindel JJ, Ho SM, Hunt PA, Iguchi T, Jobling S, Kanno J, Keri RA, Knudsen KE, Laufer H, LeBlanc GA, Marcus M, McLachlan JA, Myers JP, Nadal A, Newbold RR, Olea N, Prins GS, Richter CA, Rubin BS, Sonnenschein C, Soto AM, Talsness CE, Vandenbergh JG, Vandenberg LN, Walser-Kuntz DR, Watson CS, Welshons WV, Wetherill Y, Zoeller RT. 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.