GAITHERSBURG, Md., Oct. 31 -- The FDA erred when it determined that
the use of the common chemical bisphenol A is
safe, particularly for infants, the agency's full science board concluded
The full board, made up of independent
advisers to the FDA, unanimously endorsed a highly critical report by a
special board subcommittee on BPA. The subcommittee concluded that the
agency employed faulty science when it determined the BPA is safe as
currently used. (See: FDA
Advisers Denounce Agency's Decision on BPA Safety)
The chemical is used in packaging of infant
formula, and in molded plastic bottles and sippy
cups. The current margin of safety is 5 mg/kg, but the subcommittee
recommended lowering that level by one order of magnitude.
The full board, chaired by Barbara McNeil,
M.D., Ph.D., of Harvard, accepted the subcommittee's report after inserting
language to state that enough evidence exists to support a more
conservative margin of safety for BPA exposure among infants.
In September, the FDA issued a draft
assessment of BPA that said there was insufficient evidence to connect
commonly used levels of BPA to some health issues, including those in
meanwhile, recently banned the use of BPA in baby bottles. (See: DA
Gives Preliminary Okay to Bisphenol A in Food
Some scientists and consumer groups have
warned that the chemical might contribute to some cancers, early puberty,
alterations of the prostate and urinary tracts, and behavioral problems.
The subcommittee released its assessment of
the FDA's report earlier this week, which charged that the FDA was wrong to
dismiss a number of government and academic studies in its assessment for
not meeting the standard of "good laboratory practices."
Toxicologist Martin Philbert,
Ph.D., of the University of Michigan School of Public Health, chairman of
the science subcommittee, said he understands why the FDA assessment relied
so heavily on two studies from a field of many BPA studies, because
"good laboratory practice" studies tend to use more animals and
readily submit raw data for independent analysis.
But he said the subcommittee disagrees that
those two studies were the only "acceptable" studies to be used,
and said more recent research must be considered, including a study
published recently in the Journal of the American Medical Assocation that connected BPA to a number of
health problems including cardiovascular disease. (See: Common
Chemical Linked to Metabolic and Cardiovascular Disorders)
At today's science board meeting, Dr. Philbert reiterated the criticisms outlined in the
subcommittee's report and criticized the limited scope of the FDA's
assessment on the impact of BPA, because it examined the use of the
chemical only in food applications.
He also criticized the FDA for not including
demographic information to determine the likely number of people exposed at
each BPA concentration and for relying on too few formula samples -- which
were from the early 1990s and all from one city -- in making a
determination about BPA in baby formula.
The board called for future, large-scale
studies examining BPA exposure from a wider range of applications.
The report now goes to the FDA, which will
likely respond in the next few months, said Stephen F. Sundlof,
D.V.M., Ph.D., director of the agency's Center for Food Safety and Applied
If the FDA accepts the subcommittee's
findings, such as a lower margin of safety for exposure for infants, the
agency would likely issue new regulations. But, said Dr. Sundlof, the agency would not issue a public notice out
of fear that mothers may stop buying infant formula and attempt to make
their own, BPA-free, but less nutritious, formula.
According to Dr. Sundlof,
the FDA is already working with manufacturing companies that use BPA in
their products to develop alternatives or to figure out how to effectively
lower levels of the chemical.