FDA: More data needed to assess safety of BPA in food packaging

The FDA denied a petition from the Natural Resources Defense Council on March 30, which called for a ban on the use of bisphenol A in human food and food packaging.

The FDA said further studies or data are needed to influence its assessment and future regulatory decisions on the safety of bisphenol A (BPA).

BPA is an endocrine-disrupting chemical (EDC), a substance in the environment that interferes with hormone action, resulting in adverse developmental, reproductive, neurological and immune effects in humans and wildlife, according to The Endocrine Society.

Andrea C. Gore, PhD, Gustavus and Louise Pfeiffer Professor of pharmacology and toxicology at the University of Texas at Austin, said the decision to deny the petition has important biological relevance.

Andrea C. Gore, PhD

Andrea C. Gore

“The petition was submitted to the FDA in 2008, but the FDA only responded to it in March, 2012 — over a 3-year gap. In its original submission, the [Natural Resources Defense Council] cited existing evidence for endocrine-disrupting effects of BPA (ie, interference with the body’s hormones). Since that time, the body of evidence is far stronger that nearly all humans are exposed to BPA and have measurable levels in their tissues; that BPA remains in the body longer than originally thought and that fetuses and infants are being exposed,” Gore said.

At the 2011 Pediatric Academic Societies’ Annual Meeting in Denver, Endocrine Today reported prenatal exposure to BPA, especially during the first trimester, increased the risk for transient wheeze in children, according to research presented by Adam J. Spanier, MD, PhD, MPH, assistant professor of pediatrics and public health sciences at Penn State College of Medicine.

By age 6 months, the odds of wheeze for the high BPA exposure group compared with the low exposure group was 2.2 (95% CI, 1.24-3.97), Spanier said. By age 3 years, there was no association between the exposure level and wheeze.

Additional studies have examined the relationship between BPA exposure and other risks.

“There are also epidemiological studies published recently that show correlations between BPA and adverse cardiovascular outcomes, neurobehavioral changes and serum hormone levels,” Gore said.

David H. Dorsey, acting FDA associate commissioner for policy and planning, wrote in a March 30 denial letter to the Natural Resources Defense Council that the information provided in the petition was not sufficient enough to persuade the FDA to establish such a rulemaking.

 “As a matter of science and regulatory policy, FDA has determined that its continued scientific study, including completion of studies in progress at FDA’s National Center for Toxicological Research (NCTR), and supported by the National Toxicology Program (NTP), and review of all new evidence as it becomes available is the most appropriate course of action at this time,” Dorsey wrote.

Sarah Janssen, MD, co-signer of the petition and senior scientist in the public health program at the Natural Resources Defense Council, released a statement after the denial.

“BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call. The agency has failed to protect our health and safety — in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children,” she said.

“The FDA is out-of-step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals,” Janssen said.

Elizabeth Pearce, MD, endocrinologist and associate professor of medicine at Boston University School of Medicine, said current data from animal and human studies have been inconsistent.

“Exposure to BPA at low levels is highly prevalent in the US, with exposure reported in at least 90% of the population. Because BPA has a good deal of adverse publicity in the past few years, many companies have started voluntarily limiting BPA in their products. Therefore, even though the FDA has not prohibited its use, exposures may start to decline,” Pearce said.

Additionally, she said more studies, especially human studies, “are clearly needed to better understand the endocrine-disrupting properties of BPA and other ubiquitous environmental contaminants.”

For more information:
  • Refer to FDA Docket: FDA-2008-P-0577 for all relevant documents pertaining to the petition and denial.
  • Spanier AJ. #2805.2. Presented at: Pediatric Academic Societies’ Annual Meeting 2011; April 30-May 3, 2011; Denver.
Disclosures: No relevant financial disclosures were reported.

The FDA denied a petition from the Natural Resources Defense Council on March 30, which called for a ban on the use of bisphenol A in human food and food packaging.

The FDA said further studies or data are needed to influence its assessment and future regulatory decisions on the safety of bisphenol A (BPA).

BPA is an endocrine-disrupting chemical (EDC), a substance in the environment that interferes with hormone action, resulting in adverse developmental, reproductive, neurological and immune effects in humans and wildlife, according to The Endocrine Society.

Andrea C. Gore, PhD, Gustavus and Louise Pfeiffer Professor of pharmacology and toxicology at the University of Texas at Austin, said the decision to deny the petition has important biological relevance.

Andrea C. Gore, PhD

Andrea C. Gore

“The petition was submitted to the FDA in 2008, but the FDA only responded to it in March, 2012 — over a 3-year gap. In its original submission, the [Natural Resources Defense Council] cited existing evidence for endocrine-disrupting effects of BPA (ie, interference with the body’s hormones). Since that time, the body of evidence is far stronger that nearly all humans are exposed to BPA and have measurable levels in their tissues; that BPA remains in the body longer than originally thought and that fetuses and infants are being exposed,” Gore said.

At the 2011 Pediatric Academic Societies’ Annual Meeting in Denver, Endocrine Today reported prenatal exposure to BPA, especially during the first trimester, increased the risk for transient wheeze in children, according to research presented by Adam J. Spanier, MD, PhD, MPH, assistant professor of pediatrics and public health sciences at Penn State College of Medicine.

By age 6 months, the odds of wheeze for the high BPA exposure group compared with the low exposure group was 2.2 (95% CI, 1.24-3.97), Spanier said. By age 3 years, there was no association between the exposure level and wheeze.

Additional studies have examined the relationship between BPA exposure and other risks.

“There are also epidemiological studies published recently that show correlations between BPA and adverse cardiovascular outcomes, neurobehavioral changes and serum hormone levels,” Gore said.

David H. Dorsey, acting FDA associate commissioner for policy and planning, wrote in a March 30 denial letter to the Natural Resources Defense Council that the information provided in the petition was not sufficient enough to persuade the FDA to establish such a rulemaking.

 “As a matter of science and regulatory policy, FDA has determined that its continued scientific study, including completion of studies in progress at FDA’s National Center for Toxicological Research (NCTR), and supported by the National Toxicology Program (NTP), and review of all new evidence as it becomes available is the most appropriate course of action at this time,” Dorsey wrote.

Sarah Janssen, MD, co-signer of the petition and senior scientist in the public health program at the Natural Resources Defense Council, released a statement after the denial.

“BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call. The agency has failed to protect our health and safety — in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children,” she said.

“The FDA is out-of-step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals,” Janssen said.

Elizabeth Pearce, MD, endocrinologist and associate professor of medicine at Boston University School of Medicine, said current data from animal and human studies have been inconsistent.

“Exposure to BPA at low levels is highly prevalent in the US, with exposure reported in at least 90% of the population. Because BPA has a good deal of adverse publicity in the past few years, many companies have started voluntarily limiting BPA in their products. Therefore, even though the FDA has not prohibited its use, exposures may start to decline,” Pearce said.

Additionally, she said more studies, especially human studies, “are clearly needed to better understand the endocrine-disrupting properties of BPA and other ubiquitous environmental contaminants.”

For more information:
  • Refer to FDA Docket: FDA-2008-P-0577 for all relevant documents pertaining to the petition and denial.
  • Spanier AJ. #2805.2. Presented at: Pediatric Academic Societies’ Annual Meeting 2011; April 30-May 3, 2011; Denver.
Disclosures: No relevant financial disclosures were reported.