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September 19, 2008

Why the FDA's Notion of BPA "Safety" May Not Pass the Laugh Test

A Dow Jones story last week, titled “FDA To Face Public Upbraiding Over Ingredient In Plastic,” points to a longstanding contradiction between what federal regulators consider good science and what scientists consider to be good science.


This latest example revolves around Bisphenol A (BPA), the synthetic estrogen put into the polycarbonate plastic found in baby bottles, water bottles and the liners of some food and infant formula cans. BPA isn’t bound within the plastic, so with heating or normal wear it leaches out into the food, breast milk, formula or water in these containers.


The disagreement between the FDA and the scientific community seems to be about whether or not this is okay. The FDA claims there is no science indicating that BPA poses a risk to humans. That’s because the FDA only considers the science (i.e. toxicity studies) submitted to it by pharmaceutical companies or plastics manufacturers using something called Good Laboratory Practice (GLP). GLP criteria are those ensuring cleanliness and good hygiene in the industry-operated labs or the labs they have paid to conduct the studies.

GLP does not address at all whether the work actually done by the labs is well-designed, has answered the "right" questions from a public health standpoint, or even whether the study sent to the FDA accurately reports what happened in the lab - i.e. the experimental outcomes.

On the other hand, academic laboratories don’t go to the trouble or great expense of getting themselves certified as using GLP. The quality of their work is ensured by the fact that it’s peer-reviewed, submitted for publication and the results are made publicly available.


The not-so-funny result is that the FDA ignored hundreds of published scientific studies suggesting that BPA does pose a risk to humans, and relied instead on two industry-funded studies that were negative, but which did use Good Laboratory Practice.


What the industry studies didn’t use were the most up-to-date, sensitive techniques for measuring potential effects from exposure to BPA. This isn’t uncommon. In fact, it’s typical that the requirements codified into law that dictate which tests of chemical or product safety federal regulators require of manufacturers are scientifically out-of-date. The science of testing is ever-evolving; chemical regulations often aren’t revised for decades. In fact, the Toxic Substances Control Act, the chief law regulating industrial chemicals, hasn’t been revised since 1976.


Similarly, the EPA acknowledges there are some 140 approved pesticides that it now considers toxic to the brain and nervous system. Under the code of federal regulations, however, the EPA still doesn’t require that new pesticides be tested for neurotoxicity before being put on the market. The EPA doesn’t require that any chemical--industrial or pesticide--be tested for its potential to damage the young, developing brain before being put on the market.   


So, the next time you read a warning from scientists that some common chemical or pesticide may not be safe, followed by assurances from the industry that the FDA or EPA has called it “safe,” know this: both are right, depending on their view of what constitutes “safety” or good science.


Independent scientists are saying that the latest published science raises new concerns (or strengthens longstanding suspicions) about a chemical product already on the market. Industry, meanwhile, is saying that the chemical has been tested and passed the weak and often outdated testing standards that the FDA or EPA has set for them.


That’s why a regulator’s notion of “safe” may not pass a parent’s laugh test.


David Wallinga, M.D. is a physician and Director of the Food and Health Program at the Institute for Agriculture and Trade Policy in Minneapolis.

David Wallinga, MD

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