Bisphenol A (BPA) in Plastics and Possible Human Health Effects

^Pr^ep^ar^{ed f}^o^r^M^e^m^b^ers^an^d^Com^mⁱ^t^t^ees^of^C^ong^r^e^ss

Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics
may expose people to small amounts of BPA in food and water. Some animal experiments have
found that fetal and infant development may be harmed by small amounts of BPA, but scientists
disagree about the value of the animal studies for predicting harmful effects in people. At least
one regulatory decision in the face of the scientific disagreement has led to a congressional
inquiry into the extent to which the decision was based on good science. Legislation proposed in
April 2008, S. 2928, would prohibit use of BPA in some products intended for use by children.
Legislation proposed in June 2008, H.R. 6228, would prohibit the use of BPA in food and
beverage containers regulated by the Food and Drug Administration (FDA).

Introduc tion ..................................................................................................................................... 1
Health Effects..................................................................................................................................1
Human Exposure.............................................................................................................................2
Current Federal BPA Regulation.....................................................................................................2
Events Surrounding the Current Controversy.................................................................................3
Congressional Activity....................................................................................................................5
Conclusion ....................................................................................................................................... 5
Author Contact Information............................................................................................................6

Bisphenol A (BPA)¹ is a synthetic chemical compound produced in the United States in large ²
quantities, approximately 2.3 billion pounds annually. The dominant use is in manufacturing
certain forms of plastic: relatively hard, clear polycarbonate (PC), and epoxy resins that are used
to line food cans. Under certain conditions, BPA may migrate (i.e., be released) from PC
containers and plastic-lined cans into the food or liquids they contain.
The widespread use of BPA and the potential for human exposure, together with accumulating
scientific evidence about possible BPA toxicity, led the National Toxicology Program (NTP) at
the National Institutes of Health (NIH) to select BPA for a comprehensive review. NTP released a ³
draft “brief” on BPA on April 14, 2008. Its conclusions prompted some to call for federal
restrictions on certain BPA uses, and sparked congressional and media interest in the past and
current positions of the Food and Drug Administration (FDA). FDA regulates BPA and other
chemicals used in food containers and maintains that current uses of BPA are safe. A final NTP ⁴
monograph on BPA was released September 3, 2008.

Exposure to large amounts of BPA is acutely toxic to humans and animals, but levels of BPA
exposure from plastics are low. The possibility of human health effects from exposure to low
doses of BPA is controversial, although animal evidence of possible harmful effects has been
mounting for about 10 years. It is clear that BPA is capable of interfering with the action of
estrogen, an important regulator of reproduction and development. (Interference with hormonal
action is often referred to as endocrine disruption.) Therefore, many recent studies have focused
on the potential effects of low levels of BPA exposure on fetal or newborn rats or mice. Some of
the developmental effects seen among rodents exposed to low doses of BPA include changes in
brains and behaviors; precancerous lesions in the prostate and mammary glands; altered prostate ⁵
and urinary tract development; and early onset of puberty.
These low-dose experiments are difficult to conduct, in part because BPA is ubiquitous in the
environment. Thus, different studies have produced different results. Scientists employed by BPA
manufacturers and some independent contractors argue that the hundreds of studies conducted so
far have produced inconsistent results and are insufficient justification for more stringent BPA
regulation. Other scientists maintain that well-designed and executed studies of sufficient
statistical power on sensitive strains of laboratory rodents have clearly demonstrated the toxicity

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⁽^poly^m^e^r^iz^e^d⁾^{to f}^o^r^m^pol^y^c^a^r^bona^te^.
²^U^.^{S. D}^e^pa^r^t^m^e^{nt of}^H^e^a^{lth a}^nd^H^u^m^a^{n Se}^r^v^ic^es⁽^H^H^S⁾^,^N^a^tiona^l^T^o^xⁱ^c^o^logy^P^r^og^r^a^m^,^“^D^r^a^f^t^N^T^{P B}^r^ie^f^on
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³^Ibid^.
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^c^h^e^mⁱ^c^a^l^s^/^bis^p^he^no^l/^bis^pheⁿ^o^l.^pd^f^.
⁵^N^T^P^M^oⁿ^o^g^r^a^ph^{on B}ⁱ^s^pheⁿ^o^{l A}^,^p.^7-^8.

of low doses of BPA in mammals, and justify actions to reduce exposure for potentially
vulnerable human populations.
Some researchers have proposed that BPA may interfere with hormones that regulate functions
other than reproduction. A recently released study found that low-level exposure to BPA inhibits
the release of adiponectin from human adipose (fat) tissue. Adiponectin increases insulin ⁶
sensitivity and helps regulate glucose metabolism. The researchers hypothesize that
environmental BPA exposure may increase susceptibility to obesity and diabetes. The body of
research in this area is less extensive than that into BPA’s potential effects on reproductive
hormones.

Bisphenol A exposure in the general population comes primarily from consumption of food and ⁷
beverages. The latest national survey by the Centers for Disease Control and Prevention (CDC)
found BPA in the urine of more than 92% of the people studied, which included children six years ⁸
of age and older and adults. Among these people, the highest average concentrations were found ⁹
in children. The NTP monograph estimates that the highest daily intakes of BPA occur in infants ¹⁰
and children. BPA has been found in human breast milk, but the NTP report estimates that ¹¹
infants who are formula-fed have higher daily BPA intake levels than those who are breast-fed,
because there is more BPA in infant formula than in breast milk, and because BPA may increase
when PC baby bottles are used for formula feeding, especially if the bottles are heated. These
BPA exposure levels in humans “are similar to levels of [BPA] associated with several ‘low’ dose
laboratory animal findings of effects on the brain and behavior, prostate and mammary gland ¹²
development, and early onset of puberty in females,” according to the final NTP monograph.

Depending on its use, BPA is potentially regulated by various regulatory agencies, including the
Consumer Product Safety Commission, the Environmental Protection Agency, and the
Occupational Safety and Health Administration. BPA-containing PC polymers and epoxy resins
used in food containers—such as baby bottles and infant formula cans, respectively—are ¹³
regulated by FDA as food contact substances. FDA conducts research into the possible

⁶^H^u^g^o^{, Eric}^R^{., Bra}ⁿ^de^b^ourg^,^T^e^rry^D^{., W}^{oo, J}^e^s^sⁱ^c^a^G^{., e}^t^a^l^{., “}^B^is^pheⁿ^o^{l A}^a^t^Envⁱ^ronm^eⁿ^ta^lly^Re^le^v^a^{nt D}^o^s^e^s
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⁷^N^T^P^M^oⁿ^o^g^r^a^ph^{on B}ⁱ^s^pheⁿ^o^{l A}^,^p.^1.
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⁹^Ibid^.
¹⁰^C^e^r^t^aⁱ^{n oc}^c^u^pa^tio^na^{l g}^r^ou^ps^a^r^e^e^s^ti^m^a^te^{d to ha}^v^e^the^hig^h^e^s^{t h}^u^m^a^{n e}^x^pos^ur^e^le^v^e^ls^{. N}^T^P^M^oⁿ^o^g^r^a^{ph o}ⁿ^Bⁱ^s^pheⁿ^o^l
^A^,^{p. 2.}
¹¹^Ibid^{., p. 3.}
¹²^I^b^id^{., p. 7-}^8.
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endocrine disrupting effects of BPA. Agency regulations and guidance for industry include
recommendations and guidelines for studies of potential reproductive, developmental, and ¹⁴
neurological toxicity that may result from exposure to food contact substances. These sources
do not suggest that there is a systematic review process to study such effects that may result from
exposure to previously approved products. Some consumer groups have sought for more than 10
years to have FDA declare uses of BPA-containing food contact substances unsafe, especially in
packaging for infant formula.

In early 2007, NTP convened an expert panel to conduct a comprehensive review of the scientific ¹⁵
literature on BPA. The panel met during 2007 and issued its report on November 26, 2007. It
concluded that animal studies were sufficient to elicit “some concern” about possible effects of
BPA exposure on the neurological development of human fetuses and newborns, but “minimal
concern” about effects on the early onset of puberty or development of mammary or prostate
cancer. (The expression of “some concern” is midway in a qualitative scale used by NTP. In
order, from greatest to least, the levels of concern are serious concern, concern, some concern,
minimal concern, and negligible concern.) Some scientists disagreed with these conclusions.
NTP’s own scientists reviewed the panel report, as well as numerous studies that were not
considered by the panel, many that were completed or published in late 2007 and early 2008.
NTP then issued its draft BPA “brief” on April 14, 2008, which largely agreed with the panel
report, but expressed a higher level of concern with respect to early puberty and effects on the
mammary and prostate glands. The draft report concluded, “... the possibility that [BPA] may ¹⁶
alter human development cannot be dismissed.” Specifically, the NTP report concluded that
there is “some concern” for neural and behavioral effects in fetuses, infants, and children at
current levels of human exposure, and “some concern” in those same groups for effects on the
prostate gland, mammary gland, and on earlier age of puberty in females. Public comment on the ¹⁷
draft brief was invited through May 23, 2008.
On June 11, 2008, the NTP Board of Scientific Counselors met to review the draft report and
public comments. The Board voted to lower the level of concern for BPA’s effects on the ¹⁸
mammary gland and on the onset of puberty in females. This vote is reflected in the final
version of the NTP brief, which was included in the NTP monograph and issued September 3, ¹⁹
2008. Thus, the official NTP view is that current levels of human exposure to BPA warrant

^(...c^on^tin^ue^d)
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“some concern” for possible effects on the brain, behavior, and prostate gland in fetuses, infants,
and children; “minimal concern” for effects on the mammary gland and an earlier age for puberty
in female fetuses, infants, and children, and for workers exposed occupationally; and “negligible
concern” for all other current exposures and reproductive or developmental effects.
Canada published its risk assessment of BPA in April 2008, finding that “... the main source of
exposure [to BPA] for newborns and infants is through the use of polycarbonate baby bottles
when they are exposed to high temperatures and the migration of [BPA] from cans into infant
formula. The scientists concluded in this assessment that bisphenol A exposure to newborns and
infants is below levels that may pose a risk, however, the gap between exposure and effect is not ²⁰
large enough.” The Canadian government has said that although exposure levels are below those
that could cause health effects, they are close to those levels, and the government wants to be
prudent and reduce exposures further. It announced its intention to reduce BPA exposure in
infants and newborns by (1) banning PC baby bottles, (2) developing stringent migration targets
for BPA in infant formula cans, and (3) working with industry to develop alternative food
packaging and a code of practice.
Also in April 2008, the American Chemistry Council, which represents chemical manufacturing
companies, called on FDA to update its review of the safety of BPA in food contact applications,
saying, “The extensive body of scientific study regarding [BPA] is well documented and well
reviewed. Nevertheless, recent media reports have raised concerns about the safety and use of ²¹
polycarbonate plastic and epoxy resins, unnecessarily confusing and frightening the public.”
Shortly thereafter, FDA formed an agency-wide task force to review current information
regarding BPA in all FDA-regulated products. In June 2008, FDA asked its Science Board, the
advisory board to the FDA Commissioner, to establish a subcommittee to review research on BPA
and exposures from food containers, and deliver its findings to the Board’s annual meeting in the ²²
fall. Subsequently, Rosa DeLauro, Chairwoman of the House Appropriations Subcommittee on
Agriculture (which funds FDA), wrote to FDA urging that the Science Board review BPA ²³
exposures from medical devices as well. In August 2008, FDA published a draft risk assessment
of BPA in food contact applications, saying, “FDA has concluded that an adequate margin of
safety exists for BPA at current levels of exposure from food contact uses. At a later date, FDA
will publish a separate document that provides a safety assessment of BPA exposure from other ²⁴
FDA-regulated products.” The BPA Subcommittee of the FDA Science Board is due to meet on
September 16, 2008, to review the draft risk assessment, the NTP Brief, and other information
regarding the safety of current food-contact uses of BPA.

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Various states have enacted, or are considering, legislation to restrict use of BPA in products
intended for use by infants and children. Also, concerns about the effects of BPA are affecting
decisions in the marketplace, such as those by Wal-Mart, Playtex Infant Care, and Nalgene to stop ²⁵
allowing BPA in the bottles they produce or sell.

On January 17, 2008, John D. Dingell, chairman of the House Committee on Energy and
Commerce, and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations,
announced an investigation into the use of BPA in products intended for use by infants and
children, and FDA’s determination of the safety of current uses of BPA in FDA-regulated ²⁶
products.
On April 29, 2008, legislation (S. 2928) was introduced that would prohibit the use of BPA in
some products intended for use by a child seven years old or younger. On June 10, 2008,
legislation (H.R. 6228) was introduced that would amend FDA’s authority such that food or
beverage containers composed of BPA, or that could leach BPA into food or beverages, would be
considered adulterated and could not be marketed. The latter bill was introduced during a hearing
of the House Energy and Commerce Subcommittee on Commerce, Trade, and Consumer ²⁷
Protection on the safety of BPA and phthalates.

There is scientific consensus that exposure to high levels of BPA can cause adverse reproductive
effects in mammals. It is less clear that low-dose exposures are harmful. There is, however,
growing concern about low-dose exposures among the public, and among many scientists,
sharpened by the fact that BPA exposures within the general population are, without question,
highest in infants. The scientific debate about the safety of BPA is likely to continue, and further
reaction in the policy, regulatory, and commercial arenas is expected.

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^Com^m^e^rc^e^w^e^bs^ite^{, a}^t^http://e^ne^rgy^c^o^m^m^e^rc^e^.^hous^e^.^g^o^v^/^Inv^e^s^tig^ations^/^B^is^pheⁿ^o^l.s^h^tm^l.
²⁷^Ho^u^s^{e E}ⁿ^erg^y^an^d^Co^mm^erc^e^Co^mmⁱ^t^t^ee,^S^u^b^c^o^m^mⁱ^t^t^{ee o}ⁿ^Co^m^m^erce,^T^r^ad^e,^an^d^Con^s^u^m^{er P}^r^o^t^ectⁱ^oⁿ^,^h^eariⁿ^g
^{on “}^S^a^f^e^t^y^of^P^h^t^h^a^l^a^t^e^s^a^{nd B}ⁱ^s^p^he^nol-^Aⁱⁿ^Ev^e^r^y^d^ay^C^ons^um^e^r^P^r^od^uc^ts^,”^J^une^10,²⁰⁰⁸^,¹¹⁰^th^Cong^{., 2}^nd^Se^s^s^.,
^W^a^shⁱⁿ^gt^oⁿ^,^D.^C.^P^h^t^h^al^at^{es are a cl}^{ass o}^f^ch^e^mⁱ^c^al^{s t}^h^at^{are u}^s^ed^t^o^so^f^t^en^pl^astⁱ^c^s,^an^d^t^h^at^{are f}^o^un^dⁱⁿ^{a vari}^et^y^o^f
^c^ons^um^e^r^pr^od^uc^ts^{. F}^o^r^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^p^o^r^t^R^L³⁴⁵⁷^2,^P^h^th^ala^t^e^sⁱⁿ^Plastic^s^an^{d Poss}^ible^Humaⁿ
^He^{alth Ef}^fe^c^t^s^{, by}^Lⁱ^nda^-^J^{o Sc}^hie^r^ow^a^{nd Ma}^r^g^a^r^e^t^Miky^ung^L^e^e^.

^Li^nd^a^-^J^o^Sc^hi^e^r^o^w ^Sar^a^{h A}^.^Lⁱ^ster
^Sp^{ecialist i}ⁿ^En^vⁱ^r^oⁿ^m^eⁿ^{tal P}^o^lic^y^Sp^{ecialist i}ⁿ^P^u^b^{lic Healt}^h^an^d^Ep^id^em^io^lo^g^y
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