[Pharmwaste] F.D.A. Concerned About Substance in Food Packaging

[DeBiasi, Deborah (DEQ)]

http://www.nytimes.com/2010/01/16/health/16plastic.html?th&emc=th


January 16, 2010

F.D.A. Concerned About Substance in Food Packaging 

By DENISE GRADY

In a shift of position, the Food and Drug Administration is expressing
concerns about possible health risks from bisphenol-A, or BPA, a widely
used component of plastic bottles and food packaging that it declared
safe in 2008. 

The agency said Friday that it had "some concern about the potential
effects of BPA on the brain, behavior and prostate gland of fetuses,
infants and children," and would join other federal health agencies in
studying the chemical in both animals and humans. 

The action is another example of the drug agency under the Obama
administration becoming far more aggressive in taking hard looks at what
it sees as threats to public health. In recent months, the agency has
stepped up its oversight of food safety and has promised to tighten
approval standards for medical devices.

Concerns about BPA are based on studies that have found harmful effects
in animals, and on the recognition that the chemical seeps into food and
baby formula, and that nearly everyone is exposed to it, starting in the
womb.

But health officials said there was no proof that BPA was dangerous to
humans. 

"If we thought it was unsafe, we would be taking strong regulatory
action," said Dr. Joshua Sharfstein, the principal deputy commissioner
of the drug agency, at a news briefing. 

Nonetheless, health officials suggested a number of things people could
do to limit their exposure to BPA, like throwing away scratched or worn
bottles or cups made with BPA (it can leak from the scratches), not
putting very hot liquids into cups or bottles with BPA and checking the
labels on containers to make sure they are microwave safe. The drug
agency also recommended that mothers breastfeed their infants for at
least 12 months; liquid formula contains traces of BPA. 

BPA has been used since the 1960s to make hard plastic bottles, sippy
cups for toddlers and the linings of food and beverage cans, including
the cans used to hold infant formula and soda. Until recently, it was
used in baby bottles, but major manufacturers are now making bottles
without it. Plastic items containing BPA are generally marked with a 7
on the bottom for recycling purposes.

The chemical can leach into food, and a study of more than 2,000 people
found that more than 90 percent of them had BPA in their urine. Traces
have also been found in breast milk, the blood of pregnant women and
umbilical cord blood.

Reports of potential health effects have made BPA notorious, especially
among parents, and led to widespread shunning of products thought to
contain the chemical. Canada, Chicago and Suffolk County, N.Y., have
banned BPA from children's products. 

The government will spend $30 million on BPA research in humans and
animals, to take place over 18 to 24 months, health officials said at a
news briefing on Friday. 

Dr. Linda Birnbaum, director of the National Institute of Environmental
Health Sciences, said the research would involve potential effects on
behavior, obesity, diabetes, reproductive disorders, cancer, asthma,
heart disease and effects that could be carried from one generation to
the next. 

Activists on both sides of the passionately debated issue said they were
disappointed in the government's action. The American Chemical Council,
which represents companies that make and use BPA, issued a statement
saying BPA was safe, praising the health agencies as confirming that
there was no proof of harm to people by it, but also saying, "We are
disappointed that some of the recommendations are likely to worry
consumers and are not well founded." 

Diana Zuckerman, president of the National Research Center for Women and
Families, said the F.D.A. had not gone far enough, because its
recommendations put the responsibility on families and not on companies
making products containing BPA. In addition, Ms. Zuckerman said, the
focus on safety should not be limited to children, because studies have
linked the chemicals to heart and liver disease and other problems in
adults. 

Government evaluations of BPA have had a contentious history. The drug
agency wrote a draft report calling it safe in 2008. But shortly after
that, the National Toxicology Program, part of the National Institutes
of Health, said BPA was cause for "some concern," citing the same issues
that the drug agency is now agreeing to: potential effects on the brain,
behavior and prostate in fetuses, infants and children. 

Then the drug agency asked an independent panel of scientific advisers
to review its draft report, and the panel gave it a scathing review. It
accused the F.D.A. of ignoring important evidence and giving consumers a
false sense of security about the chemical. The drug agency promised to
reconsider BPA, and the announcement on Friday fulfilled that pledge.

"We are for the first time saying we believe there is some concern about
the substance's safety, and we've closed the gap between N.I.H. and
F.D.A.," Dr. Sharfstein of the F.D.A. said in an interview. 

Dr. Sharfstein said the drug agency had become more receptive to new
techniques of studying the safety of chemicals. Old methods involved
giving test animals large doses and looking for clear evidence of
effects like illness, tumors or organ damage. Newer methods involve
studying small doses - similar to human exposures - and looking for more
subtle effects, like changes in behavior or biochemistry. Results can be
harder to interpret and may demand more study. 

Dr. Sharfstein said the drug agency was also re-evaluating the way it
regulates BPA. The substance is now classified as a food additive, a
category that requires a cumbersome and time-consuming process to make
regulatory changes. Dr. Sharfstein said he hoped its status could be
changed to "food contact substance," which would give the F.D.A. more
regulatory power and let it act more quickly if it needed to do so. 

Gardiner Harris contributed reporting from Washington.

Correction: January 17, 2010




Deborah L. DeBiasi 
Email:   Deborah.DeBiasi at deq.virginia.gov (NEW!)
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Virginia Department of Environmental Quality 
Office of Water Permit Programs 
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PPCPs, EDCs, and Microconstituents
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