| BISPHENOL-A CONSUMER HEALTH & SAFETY INFORMATION |
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I. OVERVIEW
Products made with polycarbonate plastic or epoxy resins,
both manufactured from Bisphenol-A (BPA), are widely
used by consumers because they make our lives safer
and easier. In the forty plus years since its first
commercial use, BPA's safety has been confirmed by numerous
tests designed to evaluate potential health effects
and by government assessments of those tests.
Use of polycarbonate plastics and epoxy resins in food
and beverage containers is authorized by the U.S. Food
and Drug Administration (FDA), and the European Commission's
Scientific Committee on Food has recently confirmed
that food contact products made with BPA are safe for
their intended uses.
In the April 2003 edition of Current Biology,
Dr. Patricia Hunt and colleagues reported finding a
chromosomal abnormality in mouse eggs after exposure
to BPA. The research did not examine any potential effects
on reproduction or development in mice, and Dr. Hunt
has acknowledged that the connection between her results
and human health has not been established (Ref. 19,
22). Moreover, as Dr. Hunt stated in a recent interview,
"I think in the case of my study, no regulatory
agency is going to change their guidelines based on
the results of one study, so obviously the way science
is done is we report a finding and someone else repeats
it. So we're waiting for that replication." (Ref.
42) Significantly, the study's findings are contradicted
by numerous studies that are used by governments to
assess safety, all of which found no evidence of health
effects at levels even remotely close to what consumers
may encounter through normal use of polycarbonate and
epoxy products, including no reproductive or developmental
effects.
The FDA has reviewed the Current Biology article and
has not altered any of its safe use determinations,
nor has it indicated any intention to do so. Following
publication of the study, George Pauli, Associate Director
for Science and Policy in the FDA's Office of Food Additive
Safety, commented, "We don't have any reason to
believe that there's any effect." (Ref. 41)
Click on the links in the text for detailed information
on each of the following points.
Polycarbonate plastic and epoxy resins - safely
used for more than 40 years
Polycarbonate plastic and epoxy resins, made from
BPA, have been safely used in consumer products for
more than forty years. Polycarbonate is often used
in place of glass because it is clear, lightweight,
heat-resistant, and shatter-resistant, a significant
safety advantage. Polycarbonate is so tough it is
also used as bullet-resistant glass and is used to
make bicycle helmets and other safety equipment to
protect people from injuries. Epoxy resins are inert
materials used as linings in metal cans to protect
foods and beverages from spoilage and other contamination.
Click here for more information.
Extensive testing demonstrates safety of polycarbonate
plastic and epoxy resins
BPA has been extensively researched and tested. Government
agencies in the U.S., Europe and elsewhere have reviewed
the research data and confirm that polycarbonate plastic
and epoxy resins may be safely used in contact with
food (Ref. 14, 56). The research demonstrating the
safety of BPA includes internationally accepted tests
designed to examine potential reproductive and developmental
effects, upon which governments rely to assess safety.
These tests, examining laboratory animals over multiple
generations and conducted according to internationally
recognized standards, coupled with the assessment
of those tests by government agencies in the U.S.,
Europe, and Japan, clearly support the safety of polycarbonate
plastics and epoxy resins. Click
here for more information.
Consumer exposure to BPA is extremely low
Typical levels of human exposure to BPA are about
1 million times below levels that have been demonstrated
not to cause adverse effects in the internationally
recognized multi-generation reproductive toxicity
studies. Numerous recent studies that directly measure
human exposure to BPA have demonstrated that exposure
to adults and children is many times lower than the
levels tested in the Current Biology study
(Ref. 1, 6, 18, 31, 44, 53, 61, 65). Click
here for more information.
The body rapidly removes BPA
BPA does not accumulate in the body. The very small
amounts of BPA that may be taken into the body are
rapidly excreted. The result is that reproductive
organs would have no significant exposure to BPA and,
thus, essentially no opportunity for BPA to cause
the effects reported in the Current Biology
study. Click here for more information.
Governments have not accepted the "low-dose
hypothesis"
Governments and independent scientific bodies worldwide
have reviewed the scientific evidence on the potential
for BPA to cause health effects at very low doses.
No government body has accepted the so-called "low-dose
hypothesis." Furthermore, no study purporting
to show low-dose effects has been replicated in a
second lab, despite repeated efforts to do so. Before
a reported finding can be accepted as scientifically
valid, it is essential to ensure the results can be
reproduced, especially in a separate laboratory. Click
here for more information.
The Current Biology study's authors speculate
about effects they did not examine
Claims of potential human effects go so far
beyond the actual findings of the study that they
are scientifically dubious. The study's authors have
speculated about miscarriage and birth defects in
humans based on findings of their preliminary research
in mouse eggs. The authors' speculations are contradicted
by numerous internationally accepted studies that
specifically looked for and found no evidence of such
effects at any level remotely close to levels consumers
might encounter (Ref. 12, 39, 54). In fact, Dr. Hunt
herself has acknowledged that, scientifically, a connection
between her results and human health has not been
established (Ref. 19, 22). Click
here for more information.
The safety of polycarbonate plastic and epoxy resins,
made from BPA, is supported by extensive tests used
to evaluate potential health effects from BPA. These
studies, along with the fact that the FDA continues
to believe polycarbonate plastic and epoxy resins are
safe when used as intended, provide strong reassurance
of the safety of these products. Based on the totality
of the research, governments around the world continue
to permit the use of polycarbonate and epoxy resins
in food containers.
II. DETAILED INFORMATION ON THE SAFETY
OF BPA
Polycarbonate plastic
and epoxy resins - safely used for more than 40 years
Polycarbonate plastic and epoxy resins, made from BPA,
have been safely used in consumer products for more
than forty years.
In addition to being clear and tough, polycarbonate
has high heat and electrical resistance. It is used
in a variety of everyday products, including:
- eyeglass lenses
- bicycle helmets
- reusable food and drink containers
- construction helmets
- consumer electronics
- safety goggles
- household appliances
- medical equipment
- cell phones
- computers
Epoxy resins have an exceptional combination of toughness,
adhesion, and chemical resistance. Epoxy resins are
used in:
- linings of food and beverage cans
- electrical equipment
- adhesives
- flooring
Back
Extensive testing confirms
safety of polycarbonate plastic and epoxy resins
Reproductive and developmental testing:
Numerous studies conducted according to internationally
recognized standards and relied upon by governments
have looked specifically for reproductive and developmental
health effects. These studies have consistently found
no such effects below, at, and as much as 4,000 times
above the exposure levels in the Current Biology
study.
The key studies on which experts, government officials
and industry rely for the conclusion that there are
no reproductive or developmental risks from exposure
to BPA at levels anywhere near levels a consumer might
encounter include:
- A continuous breeding study in mice, conducted by
the U.S. government's National Toxicology Program,
showed no effects on reproduction at a dose approximately
4000 times higher than the highest dose tested in
the Current Biology study (Ref. 39).
- A study conducted at the Research Triangle Institute
examined parents and three offspring generations of
rats exposed to BPA. No evidence of developmental
or reproductive effects was found at doses anywhere
near levels to which consumers might be exposed (Ref.
54).
- A similar two-generation study sponsored by the
Japanese Ministry of Health and Welfare found no developmental
or reproductive effects at any dose tested. This study
also included two behavioral tests of offspring, including
a learning test, and found no effect of BPA at any
dose (Ref. 12).
Genetic testing:
BPA has been studied using a standard internationally
recognized test for determining genetic effects - the
mouse micronucleus assay. No such effects were found,
even at a dose 20,000 to 100,000 times higher than the
doses tested in the Current Biology study (Ref.
5).
In summary, many of the studies that ordinarily might
be conducted in response to the Current Biology
findings had previously been conducted and do not indicate
a reproductive, developmental or genetic risk.
Back
Consumer exposure to BPA is
extremely low
A person would have to consume more than 1,300 pounds
of food and beverages in contact with polycarbonate
plastic or more than 500 pounds of food and beverages
from cans lined with epoxy resins, every day for a lifetime,
to exceed the safe level of BPA set by the U.S. Environmental
Protection Agency (EPA).
Migration of BPA from polycarbonate plastic and epoxy
resins in food and beverage containers has been shown
to be extremely low. Actual human dietary concentrations
are infinitesimal. Studies of polycarbonate and epoxy
resins by government agencies, academia, and industry
have examined the typical ways consumers use polycarbonate
products, including microwaving, washing in a dishwasher,
sterilizing, and long-term storage at a variety of temperatures,
and have found that migration from these uses is generally
less than five parts per billion. Even under conditions
that go far beyond normal use, migration of BPA is well
below safe levels. For canned foods, migration is typically
less than 37 parts per billion and is so low as to be
virtually undetectable in canned beverages (Refs. 4,
9, 16, 20, 21, 25, 30, 36, 55).
Back
The body rapidly removes BPA
Studies demonstrate that the very small amounts of BPA
that may be taken into the body do not accumulate and
are rapidly excreted. The metabolism of BPA in humans
has been reported in the scientific literature in two
studies that involve human volunteers (Ref. 53, 58).
The results of both studies show that BPA is rapidly
converted to a glucuronide metabolite that is then excreted
in urine within hours after the initial exposure. These
results are consistent with the results of multiple
animal studies that also demonstrate that BPA is rapidly
metabolized (Ref. 43, 46, 48, 57). The glucuronide metabolite
of BPA does not have estrogenic activity (Ref. 32).
The scientific evidence shows that humans very efficiently
metabolize and excrete BPA, resulting in no significant
exposure of the reproductive organs to BPA.
Back
Governments have not accepted
the "low-dose hypothesis"
Various government and independent scientific bodies
worldwide have reviewed the studies that claim BPA has
the potential to cause health effects at very low doses.
No government body has accepted the so-called "low-dose
hypothesis" in general or specifically for BPA.
Notable examples include the U.S. EPA (Ref. 13), Japanese
Ministry of Economy, Trade and Industry (Ref. 23), Japanese
Ministry of Health, Labor and Welfare (Ref. 24), European
Commission Scientific Committee on Food (Ref. 14), and
European Commission Scientific Committee on Toxicity,
Ecotoxicity and the Environment (Ref. 15).
In 2000, the U.S. government's National Toxicology
Program's (NTP) Low Dose Peer Review BPA Subpanel reviewed
the available scientific data to evaluate the likelihood
of low dose effects and found that the data did not
prove the low-dose hypothesis for BPA. In its review
of studies led by low dose theorist Dr. Frederick vom
Saal, the Subpanel found a variety of problems, including
lack of proper documentation and, for one study, use
of a methodology the panel characterized as "prone
to false positive outcomes." Despite a request
from the NTP, no raw data were submitted to support
five of Dr. vom Saal's studies, so those studies could
not be evaluated at all by the NTP expert review group
(Ref. 40). In contrast, the Subpanel determined that
a number of large, statistically powerful studies in
rats and mice found no evidence for a low-dose effect
of BPA. (The Tyl study, which demonstrated no low-dose
effect after examination of over one million data points
in four generations of laboratory animals across a wide
range of doses, was considered by the NTP Statistics
Subpanel as "arguably the most comprehensive of
the studies we evaluated.") A number of these statistically
powerful studies were designed to replicate in other
laboratories the "low-dose" studies, but no
low-dose effects were found (Ref. 40). As the NTP Panel
noted, "Reproducibility of experimental results
is an important and necessary feature of any scientific
finding before it can be generally accepted as valid.
Perhaps the most important kind of replication
is reproducibility among different laboratories trying
to confirm the findings of another laboratory."
Both before and subsequent to the NTP BPA Subpanel's
review, academic, government and industry researchers
have published studies that report no effects from low
doses of BPA (Ref. 7, 8, 12, 54, 2, 3, 10, 11, 17, 26,
27, 28, 29, 33, 34, 35, 37, 38, 45, 47, 49, 50, 51,
52, 59, 60, 62, 63, 64, 66). These include studies in
separate laboratories specifically designed to replicate
reported low-dose results (Ref. 3, 7, 8, 52).
In sum, the studies purporting to show low-dose effects
were limited studies on a few laboratory animals, did
not use internationally accepted research protocols
and have not been replicated in independent laboratories.
As many governments and scientific bodies have concluded,
the weight of scientific evidence does not support the
validity of the low-dose hypothesis for BPA.
Back
The Current Biology
study's authors speculate about effects they did not
examine
The authors of the Current Biology study have
speculated about miscarriage and birth defects, effects
that could not be examined in their research on an early
phase of mouse eggs prior to cell division. The authors
did not look for actual effects after cell division.
Authoritative studies, using internationally accepted
protocols that have been validated for the evaluation
of potential health effects, have looked for evidence
of effects on fertility (the equivalent of miscarriage
in mice) and increased incidence of birth defects. These
studies found BPA to have no such effects at any level
remotely close to levels consumers might encounter (Ref.
12, 39, 54).
Back
III. SOURCES
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