How is NIEHS/NTP Researching the Health Effects of BPA?

The National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP) have developed an integrated, multipronged, consortium-based approach to optimize BPA-focused research investments to more effectively address data gaps and inform decision making.

NIEHS/NTP BPA research investments made over the past four years include extramural research grants, establishment of a BPA Grantee Consortium, intramural research activities on BPA's mechanisms of action, launch of two clinical studies and an occupational study, development of a round robin experiment to validate BPA measurements in human serum, and, in collaboration with the Food and Drug Administration (FDA), formation of a consortium to design and execute a chronic toxicity study of BPA in rats.

NIEHS's new consortium-based approach has led to more integrated, collaborative efforts and should improve our ability to resolve controversies over the potential human health effects of exposures to low levels of endocrine active agents.

Read more about this Consortium-Based Science: The NIEHS's Multipronged, Collaborative Approach to Assessing the Health Effects of Bisphenol A.

CLARITY-BPA

The Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) was developed by NIEHS, NTP, and the U.S. Food and Drug Administration (FDA). CLARITY-BPA is studying a full range of potential health effects from exposure to BPA to provide data that can be used for regulatory decisions.

CLARITY-BPA aims to create a mutually beneficial partnership that unites standard research practices used by regulators with innovative studies conducted at universities.

CLARITY-BPA has two components:

• Core Study: A two-year guideline-compliant study of potential BPA toxicity in rats, which was conducted according to federal regulatory and statutory guidelines for toxicity testing.
• Grantee Studies: Studies conducted by university researchers but testing a broader range of health endpoints, including genetic impacts, cardiovascular disease, obesity, and behavior. The Grantee Studies used animals raised in the same conditions and exposed to the same doses of BPA as the Core Study.

Final CLARITY-BPA conclusions, expected from NTP in 2019, will be drawn from the integration of the Core Study and Grantee Studies.

Read more about CLARITY-BPA

• NIEHS/FDA CLARITY-BPA research program update(Reproductive Toxicology, December 2015)
• A new approach to synergize academic and guideline-compliant research: the CLARITY-BPA research program(Reproductive Toxicology, September 2013)
• Working Together: Research - and Science-Based Regulation of BPA(Environmental Health Perspectives, July 2013)
• Consortium-based science: the NIEHS’s Multi-pronged Collaborative Approach to Addressing the Health Effects of BPA(Environmental Health Perspectives, Dec 2012)

Environmental Factor Stories

• Expert panel reviews CLARITY-BPA Core Study (May 2018)
• BPA grantees share findings(March 2013)
• NIEHS grantees collaborate with NTP, FDA on BPA studies(November 2011)

NIEHS Awarded Recovery Act Funds to Address Bisphenol A Research Gaps

NIEHS invested approximately $30 million on BPA-related research. This includes existing grants, the Recovery Act grants and supplements, in-house research and National Toxicology Program (NTP) projects. The NTP effort is part of a larger five-year commitment to collaborate with the U.S. Food and Drug Administration’s National Center for Toxicological Research to examine long-term health outcomes resulting from developmental exposures.

Researchers studying the health effects of the chemical bisphenol A (BPA) gathered in North Carolina in 2009 to launch an integrated research initiative to produce data that will allow for a comprehensive assessment of its possible human health effects.

Researchers who received funds from the American Recovery and Reinvestment Act to study BPA were brought together to meet with scientists from academia and government already working on the compound. The meeting was held Oct. 6, 2009 at the National Institute of Environmental Health Sciences (NIEHS).

Why did NIEHS use Recovery funds to support BPA research?

There is much uncertainty regarding the chemical BPA. BPA is used in certain food contact materials and was first approved by the FDA in the early 1960s. While recent assessments by authorities in the United States, Canada, Europe, and Japan agree that current food contact uses of BPA are safe, these assessments have identified the need to address data gaps. NIEHS wants to fill many of the research gaps in this area so informed personal and public health decisions can be made. For these reasons, NIEHS prioritized BPA research as a Signature initiative in the grants program undertaken with stimulus funds from the American Recovery and Reinvestment Act (ARRA). Some of the disease endpoints that Recovery Act-funded researchers will be investigating include behavior, obesity, diabetes, reproductive disorders, development of prostate, breast and uterine cancer, asthma, cardiovascular diseases and transgenerational or epigenetic effects.

What impact will the Recovery funding focused on BPA have?

The Recovery Act money will support the development of new data in a limited number of strategic areas where there is very little data. It will also help stimulate the replication and expansion of published studies that have been deemed by NTP/CERHR to have specific deficiencies. The goal of these ARRA funded grants is to produce both the animal and human data necessary to allow for a comprehensive assessment of the human health effects of BPA. Collectively, the results of these new ARRA funded studies and ongoing studies should begin to chip away at the uncertainties and research gaps and provide a better perspective of the potential threat that exposure to bisphenol A poses to public health.

What did NTP conclude in its 2008 monograph?

The NTP reached the following conclusions on the possible effects of current exposures to bisphenol A on human development and reproduction. Note that the possible levels of concern, from lowest to highest, are negligible concern, minimal concern, some concern, concern, and serious concern.

In September 2008, the National Toxicology Program (NTP) completed a review of available research on the chemical bisphenol A (BPA) and concluded that there was "some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures."

Note that the possible levels of concern, from lowest to highest, are negligible concern, minimal concern, some concern, concern, and serious concern.

• The NTP has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A.
• The NTP has minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to bisphenol A.
• The NTP has negligible concern that exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects, or reduced birth weight and growth in their offspring.
• The NTP has negligible concern that exposure to bisphenol A will cause reproductive effects in non-occupationally exposed adults and minimal concern for workers exposed to higher levels in occupational settings.

Read the report: The National Toxicology Program (NTP) Brief On Bisphenol A (BPA).

For basic information on bisphenol A, please see our health topic webpage on BPA.