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New Bisphenol A Study Is of Very Limited Relevance to Human Health

ARLINGTON, Va., June 17 /PRNewswire-USNewswire/ -- The following statement can be attributed to Steven G. Hentges, Ph.D. of the American Chemistry Council's (ACC) Polycarbonate/BPA Global Group. Dr. Hentges' comments are in regard to a study from researchers at North Carolina State University (NCSU) and the National Institute of Environmental Health Sciences (NIEHS). The study, "Neonatal bisphenol A exposure alters rat reproductive development and ovarian morphology without impairing activation of gonadotropin releasing hormone neurons," was funded by NIEHS and published online June 17 by the journal Biology of Reproduction. The study was co-authored by Heather B. Patisaul and Heather B. Adewale of NCSU and Wendy N. Jefferson and Retha R. Newbold of NIEHS.

"The American Chemistry Council (ACC) and its member companies have long-supported research to advance scientific understanding about chemicals and promote public health. To achieve these goals with limited resources, including limited use of laboratory animals, study designs should be based on sound scientific principles and data so as to be directly relevant to human health. This new study fails to meet these basic study design principles and practices.

"It is a continuing disappointment to see that researchers -- including scientists from National Institute of Environmental Health Sciences (NIEHS) -- conduct studies that involve injection of laboratory animals with bisphenol A (BPA). This experimental technique has recently been acknowledged by the NIEHS to have very limited value for assessing human health effects since people are orally exposed to BPA, not by injection. It is well-known that BPA is efficiently metabolized and rapidly eliminated from the body after oral exposure.

"The researchers also state, incorrectly, that their study is significant because it used a dose equal to the EPA reference dose for BPA, which is a science-based lifetime daily intake level determined to be safe by EPA. However, the EPA reference dose is specifically applicable only to oral exposure, not to injection exposure. Consequently, this study does not call into question the validity of the EPA reference dose.

"Although the researchers correctly note that 'the research was done on rats, making it difficult to determine its applicability to humans...', the study is of very limited relevance to human health, according to the NIEHS guidelines, due to these inherent study design flaws.

"Eleven regulatory bodies around the world have recently assessed the science on bisphenol A (BPA) and uniformly determined that BPA is safe for use in food contact products. In February, the U.S. Food and Drug Administration (FDA), in regard to their ongoing review, stated: 'With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.'"

The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care(R), common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $689 billion enterprise and a key element of the nation's economy. It is one of the nation's largest exporters, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure.

SOURCE American Chemistry Council
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