|NTP Finalizes Report on Bisphenol A
Current human exposure to bisphenol A (BPA), a chemical used in
many polycarbonate plastics and epoxy resins, is of "some
concern" for effects on development of the prostate gland
and brain and for behavioral effects in fetuses, infants and children,
according to a final report released today by the National Toxicology
The report provides the NTP’s current opinion on BPA’s potential
to cause harm to human reproduction or development. The conclusions
are based primarily on a broad body of research involving numerous
laboratory animal studies. The report is part of a lengthy review
of the scientific literature on BPA and takes into consideration
public and peer review comments received on an earlier draft report.
The final report is available at http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf.
"There remains considerable uncertainty whether the changes seen
in the animal studies are directly applicable to humans, and whether
they would result in clear adverse health effects," said NTP
Associate Director John Bucher, Ph.D. "But we have concluded
that the possibility that BPA may affect human development cannot
About the impact that these findings may have on consumers, CERHR
Director Michael Shelby, Ph.D., said,"Unfortunately, it is
very difficult to offer advice on how the public should respond
to this information. More research is clearly needed to understand
exactly how these findings relate to human health and development,
but at this point we can’t dismiss the possibility that the effects
we’re seeing in animals may occur in humans. If parents are concerned,
they can make the personal choice to reduce exposures of their
infants and children to BPA."
The NTP, an interagency federal research program at the National
Institute of Environmental Health Sciences (NIEHS), part of the
National Institutes of Health, uses a five-level scale ranging
from negligible to serious, with "some concern" being
|NTP conclusions regarding the possibilities
that human development
or reproduction might be affected by exposure to bisphenol
"We are expressing this level of concern because we see developmental
changes occurring in some animal studies at BPA exposure levels
similar to those experienced by humans," Bucher said.
The report also expresses "minimal concern" that BPA
exposure will affect development of the mammary gland or accelerate
puberty in females. The NTP expressed "negligible concern" that
exposure of pregnant woman to BPA will result in fetal or neonatal
mortality, birth defects or reduced birth weight and growth in
The NTP also expressed "negligible concern" that exposure
to BPA causes reproductive effects in non-occupationally exposed
adults and "minimal concern" for workers exposed to higher
levels in occupational settings.
"The literature on experimental animal studies is large and
filled with many conflicting findings. There are a number of remaining
uncertainties in the scientific information on BPA," said
Bucher. The report discusses many of the uncertainties, including
the very limited data from studies in humans and the difficulty
in relating the often subtle developmental endpoints in animal
studies to human health risks.
The NTP Center for the Evaluation of Risks to Human Reproduction
(CERHR) conducted the BPA evaluation. The CERHR follows a formal
process for review and evaluation of nominated chemicals that includes
convening panels of scientific experts to review the world’s scientific
literature on the chemical being studied and a peer review process,
as well as numerous opportunities for public input. For a summary
of the NTP evaluation of BPA, please see http://www.niehs.nih.gov/news/media/questions/sya-bpa.cfm#4.
CERHR publishes monographs that assess the evidence that environmental
chemicals, physical substances, or mixtures cause adverse effects
on reproduction and development and provide opinion on whether
these substances are hazardous for humans. Other agencies, such
as the US Food and Drug Administration, apply this science in carrying
out their regulatory responsibilities and in accordance with their
Last month, FDA released a"Draft Assessment of Bisphenol
A for Use in Food Contact Applications” for peer review and public
comment, available at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-0038b1_01_02_FDA%20BPA%20Draft%20Assessment.pdf.
The FDA will hold a public meeting of its BPA subcommittee of the
FDA Science Board on September 16 to discuss this FDA draft assessment.
"We are pleased to see the finalization of the NTP report," noted
Frank Torti, M.D., M.P.H., Principal Deputy Commissioner and Chief
Scientist at the FDA."The FDA will consider this final report
in our role as a regulatory agency and joins NTP in the call for
additional research in this important area. "Reporters interested
in speaking to FDA about this issue, may contact the FDA press
office at 301-827-6242.
NIEHS supports research to understand the effects of the environment
on human health and is part of NIH. For more information on environmental
health topics, please visit our website at http://www.niehs.nih.gov.
The National Toxicology Program (NTP) is an interagency program
established in 1978. The program was created as a cooperative effort
to coordinate toxicology testing programs within the federal government,
strengthen the science base in toxicology, develop and validate
improved testing methods, and provide information about potentially
toxic chemicals to health, regulatory, and research agencies, scientific
and medical communities, and the public. The NTP is headquartered
at the NIEHS. For more information about the NTP, visit http://ntp.niehs.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit www.nih.gov.