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EWG testimony to the FDA's Science Board

EWG testimony to the FDA's Science Board

Monday, November 3, 2008

October 31, 2008

Testimony by Olga V. Naidenko, Ph.D.

Hello, I'm Olga Naidenko, Senior Scientist at Environmental Working Group. I am grateful for this opportunity to present EWG position regarding the FDA's draft risk assessment for BPA in food packaging.

We are pleased with the rigor and quality of the subcommittee report, and we fully support its determination that FDA cannot substantiate the safety of current BPA uses. FDA's estimates of BPA intake for infants and adults are unacceptably close to the concentrations that show health effects in low dose toxicity studies. This seriously undermines FDA's claims about the safety of current BPA exposures, including exposure via canned liquid infant formula, canned foods and polycarbonate food containers and bottles. As demonstrated by the findings from hundreds of scientific studies in the peer-reviewed literature, the margin of safety is simply not there.

Adopting the subcommittee's recommendations as written will address most of the concerns EWG raised in written comments to the Science Board on October 24, 2008 about the short-comings in the draft assessment.

We concur with the subcommittee that using the low dose toxicity studies deemed "adequate" by the National Toxicology Program for the risk assessment will call into question the safety of adult, child and infant exposures to BPA from food packaging. Therefore we call on FDA to complete and finalize their assessment as quickly as possible.

FDA has failed to meaningfully assess BPA exposures to infants, and as noted by the subcommittee, FDA relied on decades old tests of just 14 liquid baby formula samples to calculate risks to infants. Meanwhile, there are significant differences in BPA levels by brand, as demonstrated by independent studies.

FDA's only response to the subcommittee report has been to re-state their position that BPA-laden products are not an "immediate health risk" and to chide Canada for expressing an "abundance of caution" in their recent actions to reduce infants' exposures. In fact FDA, along with allies in entrenched industries, and industry-funded scientists are the only remaining groups who feel entirely comfortable with the fact that:

  • 93% of American children and adults have daily exposures to BPA,
  • Adult exposures have been recently linked to increased risk of diabetes and heart disease. BPA also appears to interfere with cancer treatment, and
  • Formula-fed infants are indisputably the most exposed sub-group. Their health is especially at risk since they are unable to efficiently metabolize and excrete the chemical.

Canadian health authorities recently evaluated the same data available to FDA scientists and came to a markedly different conclusion. This month they announced immediate action to reduce BPA exposures for infants by banning polycarbonate baby bottles and reducing BPA levels in formula.

This is the type of bold action that is needed to protect American infants. And given that the same four formula companies sell products in the United States, U.S. infants may get roundabout protections via the action of the Canadian Government.

EWG's canned food testing found BPA in 20 brands of canned food, and BPA has been found in every major brand of liquid formula. Today we are writing these producers to ask that they voluntarily repackage their foods and eliminate BPA contamination. Formula makers can and should reduce BPA levels while safer packaging is investigated. Parents, pediatricians and the federal WIC program should be informed of the need to limit infants' BPA exposure by using non-polycarbonate bottles and BPA-free powdered formula wherever possible. These dramatic measures are needed to assure that infants are not exposed to harmful amounts of BPA while a health-protective safety assessment is being drafted.

In conclusion, FDA defines safety as "reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use." In contrast to this public health mandate, FDA's draft standard for BPA fails to protect infants and potentially adults from harmful exposures. An estimated four million babies will be born in the United States next year, and given the fact that early life exposures to BPA may permanently alter their developing brains, nervous and reproductive systems, we only have one chance to get it right and protect them from this entirely avoidable contaminant. Thus, we urge the Science Board to impress upon FDA the need for immediate actions to reduce BPA levels in food and formula.