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Weight-of-Evidence Assessment Concludes Bisphenol A is Not a Carcinogenic Risk

August 21, 2002

Summary

The International Agency for Research on Cancer and the United States Environmental Protection Agency have well-established guidelines and criteria for the assessment of carcinogenic potential. As described in a recent peer-reviewed publication, a panel of experts has applied these guidelines and criteria to the assessment of a large body of scientific evidence that is relevant to the potential for Bisphenol A (BPA) to cause cancer. The conclusion of this assessment is, “BPA is not a carcinogenic risk to humans.” This clear conclusion provides strong support for the safety of BPA and reassurance that there is no basis for human health concerns from exposure to BPA.

Extensive Scientific Evidence Available to Assess Potential Carcinogenicity of BPA

The potential for chemicals to cause cancer is typically assessed with a weight-of-evidence approach that considers a wide range of relevant toxicological and exposure information. International bodies, such as the International Agency for Research on Cancer (IARC), or national regulatory bodies, such as the United States Environmental Protection Agency (US EPA), commonly conduct such assessments using well-established guidelines and criteria. Although extensive relevant information does exist for BPA, a comprehensive evaluation of its potential carcinogenicity had not previously been conducted.

For the first time, a weight-of-evidence assessment of the potential for BPA to cause cancer has now been conducted using the guidelines and criteria established by IARC and the US EPA. This assessment was carried out by a distinguished panel of US, Canadian and European experts and recently published in the peer-reviewed journal Regulatory Toxicology and Pharmacology.¹

Bisphenol A Is Not a Carcinogenic Risk to Humans

A large body of scientific data was evaluated to reach the overall weight-of-evidence conclusion, “BPA is not a carcinogenic risk to humans.” The key data that supports this conclusion includes:

• The results of lifetime studies in rats and mice conducted by the US National Toxicology Program, which indicate that BPA lacks carcinogenic potential;
   
• A variety of standardized and validated in vivo assays of genetic toxicity, which demonstrate that BPA is without mutagenic or genotoxic activity;
   
• Metabolic data that demonstrates rapid metabolism and excretion of BPA without the formation of potentially reactive intermediates; and
   
• A minimal level of exposure of the average consumer to BPA.

These results are consistent with the conclusions of a comprehensive European Union risk assessment on BPA that has recently been completed.² The EU Risk Assessment concludes, “the evidence suggests that bisphenol-A does not have carcinogenic potential” and “it does not appear that bisphenol-A has significant mutagenic potential in vivo.”

Safety of Bisphenol A Reaffirmed by Findings

The weight of scientific evidence evaluated in this study clearly supports the safety of BPA and provides strong reassurance that there is no basis for human health concerns from exposure to BPA.

References

¹“An Evaluation of the Possible Carcinogenicity of Bisphenol A to Humans”, L. A. Haighton, J. J. Hlywka, J. Doull, R. Kroes, B. S. Lynch, and I. C. Munro, Regulatory Toxicology and Pharmacology (2002) 35: 238-254.

² The final EU Risk Assessment Report, 2003 is available on the Internet at http://ecb.jrc.it/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/bisphenolareport325.pdf