FDA Must Curb BPA

While other federal public health and environmental agencies have
targeted the plastics ingredient bisphenol A (BPA) as a chemical of
concern to human health, the Food and Drug Administration has remained
silent.

In a letter to FDA Commissioner Margaret Hamburg, Environmental Working Group President Ken Cook asked why. Cook wrote:

"Other federal agencies have singled out BPA as a major focus of
research and potential regulation. In December, the National Institutes
for Environmental Health Sciences launched a $14 million research
initiative in hopes of filling in the research gaps about the human
health risk of BPA. The Environmental Protection Agency has identified
BPA as a possible human health threat and priority for risk assessment.

Yet the FDA has remained silent. How much more does the FDA need to
know to be convinced it must protect the national food supply from
further contamination? We urge you to act now to prohibit the use of
BPA in food and food containers."

Cook's letter to Hamburg came only days after British scientists
reported finding that Americans with high concentrations of BPA in
their urine were more likely to report having heart disease or diabetes
than people with lower BPA measurements.

Authoritative studies by U.S. Centers for Disease Control and
Prevention (CDC) found that nearly all Americans test positive for
traces of BPA. An EWG study released late last year detected BPA in the
umbilical cord blood of 9 of 10 infants born in 2007 and 2008.

Cook wrote to Hamburg:

"We cannot quantify the cost to our society, in terms of medical
bills, lost productivity and troubled lives. But we are sure of this:
the price, whatever it is, is too high, and it is unnecessary."

The text of Mr. Cook's letter is below:

January 14, 2010

The Honorable Margaret A. Hamburg
Commissioner U.S. Food and Drug Administration
10903 New Hampshire Ave.
Building 1 Room 2217
Silver Spring, MD 20993-0002

Subject: FDA must act to reduce the human health burden of bisphenol A

Dear Madam Commissioner,
The Food and Drug Administration (FDA) has yet to issue its final
decision on whether bisphenol A (BPA), an industrial chemical and
synthetic estrogen, should be used in food packaging. As even the
chemical industry has acknowledged, BPA leaches into foods and
beverages from polycarbonate plastic containers and epoxy-based metal
food can linings.

As authoritative studies by U.S. Centers for Disease Control and
Prevention (CDC) have demonstrated, nearly all Americans test positive
for traces of BPA. Environmental Working Group's most recent study of
cord blood found BPA in 9 of 10 samples taken from children born in
2007 and 2008.

Dozens of animal studies suggest that very low doses of BPA disrupt
the endocrine system, undermine normal neurological and reproductive
development and trigger a variety of chronic and serious disorders such
as cancer, diminished brain function and intellectual capacity, asthma,
obesity and diabetes.

Important new research demonstrates that BPA harms not only
laboratory animals but also humans. It is significant and troubling
that physical changes are being detected even at the very low levels to
which people are routinely exposed because of BPA contamination in food
and other products.

A British study published January 13 adds to this growing body of
science by reporting that Americans with high concentrations of BPA in
their urine were more likely to report having heart disease or diabetes
than people with lower BPA measurements.

Tens of millions of children undergoing crucial windows of
development are being exposed daily to this dangerous chemical via
plastic baby bottles and sippy cups, canned infant formula and popular
foods such as canned soup. Ubiquitous BPA contamination of our food is
believed to have a subtle but lasting impact on Americans' health.

We cannot quantify the cost to our society, in terms of medical
bills, lost productivity and troubled lives. But we are sure of this:
the price, whatever it is, is too high, and it is unnecessary.

Other federal agencies have singled out BPA as a major focus of
research and potential regulation. In December, the National Institutes
for Environmental Health Sciences (NIEHS) launched a $14 million
research initiative in hopes of determining the human health risk of
BPA. The Environmental Protection Agency (EPA) has identified BPA as a
possible human health threat and priority for risk assessment.

Yet the FDA has remained silent. How much more does the FDA need to
know to be convinced it must protect the national food supply from
further contamination? We urge you to act now to prohibit the use of
BPA in food and food containers.

Thank you for your attention.

Sincerely,

Kenneth Cook
President

Copies: The Honorable Lisa Jackson, Administrator, U.S.
Environmental Protection Agency Dr. Linda Birnbaum, Director, National
Institute of Environmental Health Sciences

ATTACHMENT

Studies demonstrating BPA toxicity to humans at current levels of
exposure Health problems associated with BPA exposures in people
include the following:

• Cardiovascular disease - A study published in January 2010 links
  BPA exposures in Americans to heart disease (Melzer 2010). The work, by
  a team from the Peninsula Medical School and the University of Exeter,
  includes 1,493 American adults enrolled in the Centers for Disease
  Control and Prevention's (CDC's) National Health and Nutrition
  Examination Study (NHANES). The researchers examined the newest NHANES
  data from 2005-06 and also pooled it with 2003-04 NHANES data. They
  confirm their previous findings in 2008 that associated BPA exposures
  and heart disease from participants in the 2003-04 study (Lang 2008).
• Aggression - In a study of 249 children, researchers at the
  University of North Carolina found an association between prenatal BPA
  exposure and aggressive behavior in 2-year-olds, especially among girls
  (Braun 2009).
• Polycystic ovarian syndrome (PCOS) - Scientists at the University
  of Tokyo studied 47 women with reproductive disorders and 26 healthy
  women and found that those with polycystic ovarian syndrome (PCOS) had
  higher serum levels of BPA relative to women with normal ovarian
  function, and that there were positive correlations between BPA
  concentrations and sex hormones (testosterone and androgen) (Takeuchi
  2004). This confirmed their earlier study of 16 women with PCOS
  (Takeuchi 2002).
• Recurrent miscarriages - Researchers found higher serum BPA levels
  among 45 women with a history of recurrent miscarriages than among
  women with normal pregnancies (Sugiura- Ogasawara 2005).
• Damage to male reproductive system - Two studies of workers with
  BPA exposures similar to those measured in Americans (Calafat 2008)
  find associations with damage to the male reproductive system. A study
  of 42 men with occupational exposure to epoxy resins found that they
  had decreased secretion of follicle stimulating hormone when compared
  with men without occupational exposure to epoxy resins (Hanaoka et al.
  2002). Another study of 25 Japanese shipyard workers found BPA-exposed
  painters had lower testosterone concentrations and higher luteinizing
  hormone (Cha 2008).
• Diabetes - In 2008, scientists from the Peninsula Medical School
  and the University of Exeter examined BPA levels measured more than
  14,000 adults participating in the CDC NHANES study from 2003-04. They
  found that people with higher BPA levels were more than twice as likely
  to report a diagnosis of type 2 diabetes than individuals with the
  lowest 25% of BPA exposure (Lang 2008).

References

Braun JM, Yolton K, Dietrich KN, Hornung R, Ye X, Calafat AM,
Lanphear BP. 2009. Prenatal Bisphenol A Exposure and Early Childhood
Behavior. Environ Health Perspect. 117(12): 1945-1952. (doi:
10.1289/ehp.0900979)

Calafat AM, Ye XY, Wong LY, Reidy JA, Needham LL. 2008. Exposure of
the US population to bisphenol A and 4-tertiary-octylphenol: 2003-2004.
Environ Health Perspect. 116(1): 39-44.

Cha BS, Koh SB, Park JH, Eom A, Lee KM, Choi HS. 2008. Influence of
occupational exposure to bisphenol A on the sex hormones of male epoxy
resin painters. Molec Cell Toxicol. 4(3): 230-234.

Hanaoka T, Kawamura N, et al. 2002. Urinary bisphenol A and plasma
hormone concentrations in male workers exposed to bisphenol A
diglycidyl ether and mixed organic solvents. Occup Environ Med. 59(9):
625-8.

Lang IA, Galloway TS, Scarlett A, Henley WE, Depledge M, Wallace R,
Melzer D. 2008. Association of Urinary Bisphenol A Concentration With
Medical Disorders and Laboratory Abnormalities in Adults. JAMA.
300(11): 1303-1310. (doi:10.1001/jama.300.11.1303).

Melzer D, Rice NE, Lewis C, Henley WE, Gallowa TS. 2010. Association
of Urinary Bisphenol A Concentration with Heart Disease: Evidence from
NHANES 2003/06. PLoS 5(1): e8673. https://www.plosone.org/article/info:doi/10.1371/journal.pone.0008673

Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino T, Suzumori K. 2005.
Exposure to bisphenol A is associated with recurrent miscarriage. Hum
Reprod. 20(8): 2325-9.

Takeuchi T, Tsutsumi O. 2002. Serum bisphenol a concentrations
showed gender differences, possibly linked to androgen levels. Biochem
Biophys Res Commun. 291(1): 76-8.

Takeuchi T, Tsutsumi O, Ikezuki Y, Takai Y, Taketani Y. 2004.
Positive relationship between androgen and the endocrine disruptor,
bisphenol A, in normal women and women with ovarian dysfunction. Endocr
J 51(2): 165-9.

EWG's Letter to the FDA