Big Chem’s lock on FDA over darling hormone disruptor, BPA

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The FDA announced in December that bisphenol A (BPA), the chemical used to make plastics hard and to line cans, was safe for humans at current levels found in food. The safety assessment was based on the FDA’s four-year review of 300 BPA studies, including those done both by independent academic scientists and industry scientists.

End of story? No chance.

Answering the question of whether BPA is safe comes down to which scientific methods are assigned more weight, and that’s where the industry has the FDA locked up over BPA. Regardless of findings that BPA is linked to serious health effects by thousands of scientifically rigorous, reliable and valid independent studies, if those findings did not meet the guidelines for the FDA’s final safety assessment, they were not considered in the 2014 decision.

In the end, the FDA rejected almost all the independent academic studies because it favors Good Laboratory Practices (GLP), the methodology industry studies use to track its data, which differs from the system used by academic scientists.

Independent academic studies should not be ignored

“Using GLP in no way says that you asked the right questions,” Linda Birnbaum, director of the NIH’s National Toxicology Program and National Institute of Environmental Health Sciences told Mother Jones. “Academic research groups have their own quality controls, which tend to be very high level. From my point of view, that’s a lot better than GLP.”

Using GLP criteria, the FDA discounted non-industry and non-government studies for lack of sample size, issues around litter size used for testing, the range of doses administered, and issues related to scientific controls for BPA contamination.

“Although the FDA looked at all the BPA studies we consider significant, they rejected their relevance because they did not meet a ‘risk assessment’ threshold. As a result, the FDA discounted good science, and therefore did not find evidence that would change their current position that low-level exposure to BPA is safe,” said Sharima Rasanayagam, Ph.D, director of science for the Breast Cancer Fund.

Thousands of peer-reviewed studies have raised concerns about BPA’s safety, finding a host of negative health outcomes linked to low-level BPA exposure including breast cancer, birth defects, neurological problems, early puberty, obesity and cardiovascular issues.

Given that more than 90 percent of Americans are exposed to BPA and diet is considered a major route of that exposure, everyone is at risk. Research also shows BPA has been found in the blood and urine of pregnant women, in the umbilical cord blood of newborns, and in breast milk soon after women gave birth, indicating that pregnant women exposed to BPA can easily pass this chemical to their children during pregnancy and breastfeeding.

FDA’s CLARITY Study: Breakthrough or Bust?

The significant concerns about BPA’s negative impact on human health led the FDA to propose a study design that would breach the impasse over GLP industry studies versus academic studies by comparing the effectiveness of these different approaches to evaluating the safety of BPA exposure. In 2012, the CLARITY program was launched as a collaboration between the FDA, the National Institutes of Health (NIH) and a dozen academic scientists who study BPA. CLARITY – Consortium Linking Academic and Regulatory Insights on BPA Toxicity – is a $32 million project that could represent a breakthrough for the government to consider academic studies as the basis of rulemaking. “It presents a path forward for regulatory agencies to make use of data from academic scientists who have developed state of the art techniques,” said Thomas Zoeller, a CLARITY participant and professor of biology at the University of Massachusetts-Amherst.

But there are already signs the CLARITY process may lead to increased discord. Some of the scientists involved called foul on the FDA’s safety assessment announced in December– which is based on solely on the GLP standards – for undermining CLARITY studies currently in process.

Another issue is that the integrity of the CLARITY project is threatened by a contamination problem in the FDA lab where the animals were being housed. Somehow, despite all the FDA’s much vaunted contamination controls, all the animals – including the unexposed control group – have been exposed to BPA.

“The major concern for the CLARITY study is that all the controls are contaminated and therefore the study results will not be valid for low-dose BPA effects,” said Rasanayagam of the Breast Cancer Fund.

State and federal legislation to get BPA out of food and beverage containers

In the meantime, legislative proposals and market-based campaigns are underway with the goal of eliminating BPA from food products. The Breast Cancer Fund’s Cans Not Cancer campaign, launched in 2011, is generating public pressure on canned food manufacturers to stop lining cans with BPA and move toward safer alternatives. The Campaign collected 70,000 messages to canned food manufacturers, and helped secure a public commitment from Campbell Soup Company to phase out BPA.

After years of consumer uproar, 12 states passed laws banning BPA from infant products, with three of those states extending the ban on BPA to infant formula and baby food. Following the lead of these states and a long list of retailers and manufacturers that banned BPA in food containers for young children, including CVS, Gerber, Kroger, Safeway and Toys R Us, the FDA ended its authorization of BPA in baby bottles and sippy cups in July, 2012. A year later, in response to a petition from then Rep. Edward Markey, D-Mass., the FDA also banned the use of BPA in infant formula packaging.

Further Congressional action is possible, as Sen. Edward Markey, D-Mass., is likely to re-introduce the Ban Poisonous Additives Act, which would ban BPA in all food packaging.

BPA: Too valuable for the industry to lose?

The bottom line on BPA is the chemical industry is not going to give it up without a fight. BPA is one of the most common chemicals we’re exposed to every day, from food and beverage containers to dental fillings and register receipts. The ubiquity of BPA is the telltale sign of how significant it is to chemical industry giants, including ExxonMobil.

To put the BPA fight in perspective, consider another chemical, benzene. ExxonMobil also manufactures benzene, a well-established carcinogen that has sickened and killed workers, according to years of litigation. But, according to an important investigative piece by The Center for Public Integrity, the industry is more committed to downplaying the health effects of benzene and spending years in litigation, rather than give the stuff up. It’s just too valuable to the industry to lose.

The Breast Cancer Fund knows what we’re up against, but we’re not going to stop advocating, educating, organizing, and pressuring decision-makers to chart a new course to a toxic-free, cancer-free economy that will bring untold benefits to businesses, people and the planet.

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3 thoughts on “Big Chem’s lock on FDA over darling hormone disruptor, BPA

  1. Thanks for your article. I am concerned about the use of styrofoam trays in public school lunches. They are in direct contact with hot food. I have actually seen the styrofoam melted a little. Schools with Pre-K have 3 and 4 year olds eating off these every day.

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