DZ's testimony for posting

[Guest guest]

Awesome !

Now, I have a question, since there is

epoxy adn epoxy resin used in breast

implants, doesnt that mean there is

BPA in breast implants that have the

epoxy and epoxy resin ? If so, it would

be so nice if she included breast implants

in her reports and testimonies .....

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[Guest guest]

Statement of

Zuckerman, Ph.D.

President, National Research

Center for Women &

Families

At the FDA Public Meeting on its Draft Assessment of

Bisphenol A for Use in Food Contact Applications

September

16, 2008

I

am pleased to have the opportunity to testify as president of the National Research Center

for Women & Families. Our nonprofit

research and education center does not accept contributions from companies that

make medical products that we evaluate, or competing companies, and so I have

no conflicts of interest.

Our

Center is dedicated to improving the health and safety of adults and children,

and we do that by scrutinizing medical and scientific research to determine

what is known and not known about specific treatments and prevention

strategies, and to compare their safety and effectiveness.

In

addition, I am a fellow at the University of Pennsylvania Center for Bioethics,

and a board member for two nonprofit organizations that work to improve

resources for the FDA: the Alliance

for a Stronger FDA, and the Reagan Udall Foundation.

I

was trained in epidemiology at Yale

Medical School;

I have worked on federal health policy issues in Congress, the White House, the

Institute of Medicine, and for nonprofit

organizations for 25 years; and I have reviewed FDA safety issues for almost 20

years.

Bisphenol A (BPA)

BPA is used in a variety of products

including reusable water bottles, baby bottles, and plastic tableware. Epoxy resins made with BPA are used to coat

the insides of canned foods and beverages.

There is no debate that BPA leaches out of plastic into liquids

and foods. The Centers for Disease

Control and Prevention (CDC) found measurable amounts of BPA in the bodies of

more than 90 percent of the U.S.

population studied. [1]

FDA Draft Assessment Conclusion

The FDA

Draft Assessment concluded “that an adequate margin of safety exists for BPA at

current levels of exposure from food contact uses.”

The

FDA’s conclusions are primarily drawn from two-industry funded studies, one of

which was sponsored by the American Plastics Council and the other by the

Society of Plastics Industry.[2]

In

contrast to the industry-funded studies, more than 150 government-funded BPA

experiments on lab animals and tissues reported adverse effects, while only 14

did not. These statistics were compiled

by the journal published by the American Chemical Society, the professional

association for chemists.

However,

13 out of 13 industry-funded studies found no adverse effects.[3] It seems that “He who pays the piper calls

the tune.”

In

addition, the FDA’s estimates of exposure are based on questionable data. On

page 7, the FDA draft report explains that the studies by FDA laboratories were

done in the early 1990’s—more than 12 years ago. The study was based on only 14 samples of

infant formula representing 5 brands purchased in Washington, DC

supermarkets. Is that representative of

all infant formula cans in the early 1990s or today? No. In

an update from this past June, an FDA official pointed out that studies of more

recent samples of infant formula have found a more dramatic range of BPA levels. The FDA has stuck with their old estimate of

6.6 ppb as the maximum level, but it is not the maximum level, as the FDA well

knows. In fact, 6.6 ppb is lower than

the level found in several other studies.[4]

What does “some concern” mean?

The FDA Draft

Assessment focuses on cancer and reproductive and developmental toxicity of

BPA. They quote the National Toxicology

Program’s report, which concluded that “some concern” exists for developmental

toxicity, and less concern for other risks.

Unfortunately,

the terminology used is misleading. The

National Toxicology Program is judging their “concerns” on the basis of how conclusive the research evidence is. The research on rats and mice and tissue

can’t be considered conclusive regarding human health. But, this does not mean there is conclusive

evidence that there is no need for concern.

The lack of conclusive evidence is not the same thing as the evidence of

safety.

On the

contrary, the weight of the evidence, especially the unbiased evidence of

government-funded research, is that we should be concerned.

The FDA relies

on industry for research everyday, but in this case there is an abundance of

well-designed studies that are being discounted for inappropriate reasons, such

as the lack of good laboratory practices (GLP).

GLP are industry standards – they have nothing to do with whether the

study is well designed or not. A poorly

designed study using GLP will not provide accurate safety information, and that

is exactly the problem we have with the industry studies FDA relied on. In academia, science is built on replication

by different scientists in different labs.

Most Independent Studies Show Risks

of BPA

Well-respected

scientists from across the country have found that BPA is potentially dangerous

for humans. Many of these scientists worked

together on the Chapel Hill Consensus Statement on BPA, which expressed strong

concerns about the impact of BPA on human health.

The

Statement also noted increases in neurobehavioral problems, such as attention

deficit hyperactivity disorder and autism, increases in childhood and adult

obesity and Type II diabetes, decrease in sperm count, and increases in

hormonally mediated cancers, such as prostate cancer.[5]

Several

newly published studies support the concerns of the Chapel Hill Consensus

Statement. Several of these studies were

not published in time to be considered by the National Toxiciology Program or

the FDA.

Researchers

at Yale just published the first study of the effect of BPA on primates, which

demonstrated “an adverse effect of BPA on the brain…and further amplifies

concerns about the widespread use of BPA…in food preparation and storage.”[6]

A study that

is published online in Environmental

Health Perspectives and will soon be in print concluded that low doses of

BPA could inhibit the release of a key hormone (adiponectin) that protects

humans from the metabolic syndrome, thereby linking BPA to an increase in heart

attacks and Type II diabetes.

In addition,

a study in this month's issue of Endocrinology

found that young female mice exposed to BPA showed brain and behavior traits

more typical of male mice.

A study in

the June issue of Cancer Research

showed a correlation between rats that had early BPA exposure and those that

developed prostate cancer in later life. The study was done by Shuk-mei Ho,

head of environmental health at the University

of Cincinnati, and Gail Prins,

physiology professor at the University

of Illinois in Chicago.

Risks vs. Benefits

Companies

that make plastics and plastic food and beverage containers have said that BPA

has been used for years and therefore it is safe. We’d like to believe it, but wishing doesn’t

make it so. There are several disturbing

disease trends that coincide with the increased use of BPA, such as Type II

diabetes, learning disabilities, and breast cancer. And, of course, the lag time between exposure

to a carcinogen and developing cancer is usually 15-20 years or more. If it weren’t so long, we’d have a lot of

Americans dying of lung cancer in their 20’s and 30s.

What Should The FDA Do?

The most

disturbing aspect of the FDA report is the conclusion that BPA at current

levels is safe when the FDA does not know what current levels are and doesn’t

have well-designed research to conclude that they are safe.

The FDA

estimates of BPA are based on studies of 14 samples sold more than 12 years

ago, in supermarkets in Washington,

D.C. We need more recent measurements in a larger

number of products sampled from stores across the country.

The

draft assessment states: “FDA does not

have a specific list of BPA-containing end products as provided to

consumers.” Why not? Without it, we don’t really know what the

exposure is, and consumers can’t avoid BPA-tainted products.

The FDA

should not draw conclusions that are biased and premature.

While

the FDA is deciding what to do about BPA in food containers, they should at the

very least empower consumers by requiring that food and beverage containers

list whether or not they contain BPA.

But

ultimately, it is not fair to consumers to give them information (this

container has BPA!) without explaining the implications. For that reason, the FDA should ban the use

of BPA or at the very least require reduced levels of BPA until more conclusive

studies can be performed to assure the American public that the chemical is

safe. I think we can all agree that

there is no clear evidence that the products are safe, the only question is

whether they are unsafe.

Alternatives to BPA Available

Alternatives

include oleoresinous, vinyl, or PET film lamination to line cans, and glass

bottles, polypropylene bottles and bottles with polymeric liners for baby

bottles.

Other Countries Are Reducing BPA

Exposure—But Not The U.S.

Japan has taken measures to reduce BPA

in consumer products, such as canned beverages and plastic tableware. They are

using different linings for beverage cans, which either contain no BPA or leach

only a small amount of BPA, and plastic tableware that had BPA has been

replaced with tableware that does not.[7]

In the United States, the NTP points out

that “exposure to bisphenol A may be increasing” and the median levels of BPA

in human urine doubled from 1988 to 2004.[8]

Responsible retailers are not

waiting for the FDA to act. Wal-Mart and

Toys-R-Us have pledged to remove products containing BPA from their shelves at

the end of 2008.[9] Bottle

manufacturers such as Playtex and Nalgene are using non-BPA materials for their

products.

Keeping Consumers Safe

It is

your job and the job of the FDA to make sure that food and beverage containers

don’t increase the risks of food and beverages.

The bottom line is we just don’t know if BPA in infant formula cans and

other food containers is safe.

More

than 100 studies have raised doubts about the safety of BPA, and alternatives

to BPA are available. If the FDA is to

err, it should be on the side of consumer safety, not corporate profits, by

banning BPA in baby bottles, plastic tableware, foods and beverages, and other

products.

Footnotes

[1] Hileman, B., (2007, April). Bisphenol A on Trial, Chemical

& Engineering News Government & Policy, Vol. 85, Number 16. http://pubs.acs.org/cen/government/85/8516gov2.html

[2] Ibid.

[3] Hileman B., (2007, April). Ibid.

[4] ,

A, June 2, 2008 Update on Cumulative Exposure to BPA, Memorandum to the File,

Division of Food Contacts Notification, http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-0038b1_01_07_FDA%20Reference%20Material-FDA%20Memo%20Cumulative.pdf

[5] vom

Saal, F., (2007). Chapel

Hill Bisphenol A Expert Panel Consensus Statement: Integration of Mechanism, Effects in Animals

and Potential to Impact Human Health at Current Levels of Exposure, Reproductive Toxicology.

[6] Leranth,

C., et.al., (2008). Bisphenol A prevents the synaptogenic

response to estradiol in hippocampus and prefrontal cortex of ovariectomized

nonhuman primates, Yale University School of Medicine, The National Academy of

Sciences. http://www.pnas.org/content/early/2008/09/02/0806139105.abstract?sid=a6820950-175f-4d84-86b1-035e4b42213b

[7] Advanced

Industrial Science and Technology.

2007. Risk Assessment Document:

Bisphenol A.

[8] National

Toxicology Program, U.S. Department of Health and Human

Services, Center for the Evaluation of Risks to Human Reproduction, (September

2008). NTP-CERHR Monograph on the

Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08-5994.

[9] -Pope, T., (2008, April 22). A Hard Plastic is

Raising Hard Questions, The New York Times.