A
few weeks ago the U.S. National Toxicology Program (NTP) released the results
of the largest study ever conducted on bisphenol A (BPA). The CLARITY Core study was conducted by
senior scientists with the U.S. Food and Drug Administration (FDA) in their own
laboratory in Arkansas known as the National Center for Toxicological Research
(NCTR).
More
important than size is the unprecedented scope of the study for this substance. The laboratory animals were exposed to BPA
from the beginning of pregnancy through the full lifetime of the offspring. A wide range of BPA doses was tested, ranging
from a low dose near actual human exposure levels to a high dose approximately
250,000 times above typical human exposure.
The world has never seen a study on BPA of this scope and magnitude.
The
results indicate that BPA has very little potential to cause health effects
even when we are exposed to it throughout our lives. As stated in the conclusion of the study
report, “BPA produced
minimal effects that were distinguishable above background.”
Considering
that BPA has been a controversial topic for many years, including public
concerns about the safety of food that contains traces of BPA, it would be
inexcusable if FDA did not communicate with the public on what the study
means. As part of its mission,
FDA is “responsible for protecting the
public health by … ensuring the safety of our nation's food supply.”
And,
very appropriately, FDA did communicate to the public. In conjunction with release of the NTP
report, FDA released a statement
that provided its current perspective on the safety of BPA. With the new information from the CLARITY Core
study in hand, FDA stated: “our initial
review supports our determination that currently authorized uses of BPA
continue to be safe for consumers.”
Importantly,
the statement also included additional context on the CLARITY study and a short
summary of FDA’s extensive activity related to BPA over many years, including
both scientific review and research. Nevertheless,
some have criticized
FDA as having spoken prematurely, saying that FDA should have waited for the
results of additional studies.
Taken
out of context, FDA’s statement could seem premature. But there is context, quite a bit of it in
fact, that gives FDA a clear basis to make a timely statement now. Not only does FDA have a strong scientific basis
to support its statement, its mission gives it a mandate to inform its
stakeholders – the U.S. public – on matters related to food safety.
The
recent FDA statement also included the context that this was the agency’s initial
review of the CLARITY Core study and that FDA would fully participate in the
upcoming peer review of the study. And,
as noted on its website, “FDA continues to review the available information and studies on BPA,
including the newly released draft NTP report (CLARITY-BPA), and will update
its assessment of BPA and take additional action if warranted.” As it should be, FDA’s actions now and in the
future are based on science, not speculation.
What Data Was FDA’s
Statement Based On?
As
noted at the very beginning of FDA’s recent statement, “FDA looks at all available scientific evidence when reviewing the
safety of foods and food packaging” and “[w]e
base our regulatory decisions on robust science.” That’s not just empty talk since there is
ample documentation of FDA’s intensive review over many years of the safety of
BPA.
Its
previous updated safety assessment from June 2014 is readily available on the
FDA website
along with a series of lengthy reports that document FDA’s detailed review of
numerous studies that are potentially relevant for its assessment. Rather than being premature, FDA’s recent statement
builds on its previous reviews to incorporate significant new information from
the CLARITY Core study.
And
FDA has done far more than just review scientific evidence. As further noted in FDA’s statement, “we not only continue to evaluate available
data – but also conduct FDA research on the safety of the use of BPA for food
packaging.”
Over
the last 5+ years, FDA scientists have generated some of the most important scientific
data on BPA, with the CLARITY Core study being only the most recent of a series
of in-depth studies. For example, from studies
in rodents and non-human primates, we know that BPA is deactivated and quickly
eliminated from the body after exposure.
From this data it can be predicted that BPA is not likely to be harmful,
which was resoundingly confirmed in the CLARITY Core study.
Along
with these important contributions from FDA, scientists from NTP and the U.S.
Centers for Disease Control and Prevention (CDC) have also conducted studies
that provide critical support for FDA’s safety assessment. In particular, NTP’s study on human
volunteers confirmed the rapid elimination of BPA from the human body. A series of six biennial studies (so far)
from CDC confirm that human exposure to BPA in the U.S. population is extremely
low.
What Data Is Yet To Come?
The
CLARITY
program (Consortium
Linking Academic and Regulatory Insights on BPA Toxicity) was designed
by a consortium that consists of FDA, NTP, the National Institute of
Environmental Health Sciences (NIEHS) and thirteen academic scientists. The CLARITY Core study, which is the
principal part of the program, was funded by NTP and conducted by FDA
scientists at NCTR. The academic
scientists not only participated in the study design, but each received funding
from NIEHS to conduct additional measurements on animals or biological samples
that were taken from the Core study. The
funding for the academic studies has all been provided and the animals or
biological samples were all provided 4-5 years ago.
As
noted
by Dr. John Bucher of NTP: “It would have been nice if we would have been
able to have all of the grantee information available at the same time as the
core study information, to be evaluated together. The process wasn’t optimal.” That begs the question why the grantee
information is not available.
Up
to the present time, only four of the thirteen academic scientists have
published their results in the scientific literature, with the first paper
published in 2015. Similar to the
results of the CLARITY Core study itself, the published results collectively
show minimal effects above background.
The
other nine academic scientists have not yet published their results, even
though they have received their funding and all animals or biological samples
for their research were provided 4-5 years ago.
This does not seem to be matter of a suboptimal process.
Ironically,
some of the scientists who have not published their results are ones who have
criticized FDA for a premature statement.
Regardless of whether the academic scientists publish their results or
not, all raw data from their research is now scheduled to become publicly
available in August 2018, at which time it can be evaluated by others.
The
bottom line is that FDA’s recent statement on BPA is neither premature nor
unfounded. It was simply transparent and
responsible. The research and analysis
conducted by FDA scientists, along with supporting data generated by other
federal government scientists, is truly monumental and fully supports FDA’s
perspective on the safety of BPA.
Furthermore, the recent statement is timely and fully within FDA’s
public health mission regarding the safety of our food supply.
