Hi folks,

I received the following from Faith Gagne...

Mike D.

------- Forwarded message follows -------
From:           "Faith Gagne" <[email protected]>
Subject:        Re: FDA to Look at Nano-products...Again
Date sent:      Tue, 02 Sep 2008 21:52:40 -5

Hi Mike,

I am on the mailing list of the Center for Food Safety.  They email me
from time to time when they want support for the issues on food safety
they are pushing with government agencies and the like.  They have my
name, address and email address and they send me form letters already
signed by me (so to speak)  so that all I have to do is "Okay" it by
clicking a submit button.

Usually I am very willing to support the issues they bring up, but I
did
not do that this time.  I do not like their premise that nano-products
like nanosilver MAY be dangerous, MAY cause cell death, MAY have a risk
of increased toxicity, MAY be potentially hazardous to human health,
etc., etc..   They are raising a lot of red flags with absolutely no
proof whatsoever.

It seems a little ironic that the FDA is supporting some nanotech
products now when they are the ones who took CS off the market years
ago.

Anyway,  I emailed the Center for Food Safety,  refusing to sign their
letter, and telling them why.  They and their scientists must first
come
up with some proof of all these allegations before they will get my
approval.

I wondered if the letter they wanted me to sign would be of interest to
the group, and if you would be interested in posting it.  I just
thought
people should know about this and maybe even write the CFA themselves.


Please let me know. thanks.

Best Wishes, Faith




----- Original Message -----
From: Center for Food Safety
To: Faith Gagne
Sent: Tuesday, September 02, 2008 12:36 PM
Subject: FDA to Look at Nano-products...Again



     FDA to Look at Nano-products...Again

     Dear Faith,


     The Food and Drug Administration is once
     again holding an "information gathering"
     public meeting on nanotechnology, a
     powerful new technology for taking apart
     and reconstructing nature at the atomic
     and molecular level.  Like Yogi Berra
     said, "it's déjà vu all over again."

     FDA held the same meeting two years ago,
     in autumn 2006.  Even then, the agency
     was behind the curve: Many products that
     contain unlabeled nanomaterials,
     including food and food packaging
     products, were already on market
     shelves.  Now, two years have passed
     since that meeting and the agency's
     continuing stance can be aptly
     summarized as "all talk, no action."

     Many new nano-products continue to come
     to market, at an average of four to five
     a week.  Unfortunately nano-products are
     still treated by FDA like any other
     products or product ingredients; yet
     scientists agree that nanomaterials are
     fundamentally different substances that
     create new and unique risks to human
     health and the environment and need new
     forms of safety testing.

     A public comment period is open now
     through October 24, 2008 - Take action
     now!



     Send a letter to the following decision
     maker(s): Docket No. 2008-N-0416 c/o The
     Center for Food Safety


     Below is the sample letter:

     Subject: Docket No. 2008-N-0416 and
     Docket No. 2006P-0210

     Dear [decision maker name automatically
     inserted here],

     Division of Dockets Management (HFA-305)
     Food and Drug Administration 5630
     Fishers Lane, Room 1061 Rockville, MD
     20852

     Comments on Docket No. 2008-N-0416 and
     Docket No. 2006P-0210(FDA regulation of
     nanotechnology materials; public
     meeting)

     I write to express my serious concerns
     about the FDA's regulatory oversight of
     nanomaterials in consumer products.

     Hundreds of consumer products containing
     manufactured nanomaterials are already
     available on U.S. market shelves,
     including food and food packaging
     products. New nanomaterial products are
     coming out at a rate of four to five a
     week.

     In the absence of labeling, public
     debate or laws to ensure safety,
     products created using nanotechnology
     have entered the food chain. Millions of
     dollars are being spent by government
     and industry to apply nanotechnology in
     areas of food processing, food
     packaging, and agricultural production.

     Industry analysts estimate that there
     are between 150-600 nano-foods and
     400-500 nano-food packaging products
     already on market shelves worldwide.

     Scientists have found that the
     fundamental properties of matter can
     change at the nano-scale, creating
     physical and chemical properties
     distinct from those of the same material
     in bulk form. We know that the new
     properties of nanomaterials also create
     new risks, like enhanced toxicity, and
     there is a growing library of scientific
     studies demonstrating that some of the
     nanomaterials now being used in foods
     and agricultural products introduce new
     risks to human health and the
     environment.

     Nanoparticles can gain assess to the
     blood stream following ingestion. Once
     inside the body, the super-tiny size of
     these materials gives them unprecedented
     mobility and access to the human body;
     they can access cells, tissues, and
     organs that larger particles cannot. The
     length of time that nanoparticles remain
     in organs and what dose may cause
     harmful effects remains unknown.

     It does not appear that FDA is ready for
     this wave of nano-food products. I am
     very concerned about the rapid
     introduction of these potentially
     hazardous nanomaterials into our bodies
     and into our environment without
     adequate scientific study to ensure that
     we understand their risks and can
     prevent harm occurring to people and the
     environment.

     For these reasons, I strongly request
     that FDA act urgently to shore up its
     regulation of these substances to
     account for their fundamentally
     different properties and their
     associated dangers, including requiring
     new nano-specific testing and the
     labeling of all nanomaterial products,
     including nano-food products.

     Because there are no regulations to
     require labeling of nano-ingredients and
     additives in food and packaging there is
     no way for anyone to choose to eat
     nano-free. Only with labeling can I make
     educated decisions about what I buy and
     put in and on my body. Until such
     actions are taken, I fully support a
     moratorium on the manufacture of
     nanomaterial consumer products and the
     recall of products currently on the
     market.


     Sincerely,

     [member "signature" goes here]




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     What's At Stake:


     Nanotechnology is a powerful platform
     technology to take apart and reconstruct
     nature  at the atomic and molecular
     level.
     It involves the manipulation of matter
     at the nanometer (nm) scale, one-billionth
     of a meter.  The nano-scale is
     exceedingly tiny: A human hair is huge
     by comparison, about 50,000 nm thick;
     the head of a pin is about 1 million nm
     across.

     Scientists have found that the
     fundamental properties of matter can
     change at the nano-scale, creating
     physical and chemical properties
     distinct from those of the same material
     in bulk form. Nanoparticles have
     unprecedented mobility, and readily
     enter the human body and gain access to
     the blood stream via inhalation and
     ingestion. In addition, the jury is
     still out on the ease of nanoparticles'
     ability to penetrate the skin. Studies
     have raised numerous red flags, with
     some showing that certain nanoparticles
     can be toxic to human tissue and cells.
     Once inside the body, nanoparticles can
     cross biological membranes, cells,
     tissues, and organs more efficiently
     than larger particles. Once in the blood
     stream, nanomaterials can circulate
     throughout the body and can be taken up
     by the organs and tissues including the
     brain, liver, heart, kidneys, spleen,
     bone marrow, and nervous system.  In
     addition, unlike larger particles,
     nanoparticles are transported within
     cells and taken up by cell mitochondria
     and the cell nucleus, where they may
     interfere with normal cellular function,
     cause oxidative damage and even cell
     death.  The length of time that
     nanoparticles remain in organs and the
     dosage that may cause harmful effects
     remains unknown. Scientists agree that
     because of their new properties and
     seemingly limitless mobility,
     nanoparticles can create new and unique
     risks to human health and the
     environment, notably enhanced toxicity.
     These risks require new forms of safety
     testing.  Existing studies have raised
     red flags demonstrating that current
     nanomaterials already in commerce may be
     extremely damaging to living organisms
     and systems.

     By 2010 the nano-food market could be
     worth $6 billion.  Many of the world's
     leading food companies - including H.J.
     Heinz, Nestle, Hershey, Campbell,
     General Mills, PepsiCo, Sara Lee,
     Unilever, and Kraft - are investing
     heavily in nanotechnology applications.
     Nanoparticles of silver, titanium
     dioxide, and zinc oxide, materials now
     used in dietary supplements and food
     packaging, have been found to be highly
     toxic to cells in studies.  Nano-silver,
     the most common commercialized
     nanomaterial, is being used in numerous
     food packaging items, cutlery, baby
     bottles, and kitchen appliances and
     cleaners for its "germ-killing" power.
     This same powerful strength can destroy
     important beneficial microorganisms in
     nature as well.

     Moreover, the unregulated
     commercialization of these products
     poses unknown dangers to the environment
     once they are released into the waste
     stream. The same unique mobility and
     toxicity concerns that apply to human
     health apply to the environment.  Even
     simply detecting these engineered
     substances in the environment is a new
     challenge.

     Thus far, nanotechnology-laced products
     are treated by the Food and Drug
     Administration (FDA) like any other
     products or product ingredients.  In
     2006 CTA, joined by other consumer
     health and environmental groups,
     petitioned FDA to stop ignoring the new
     dangers presented by these nanomaterials
     and force manufacturers to label these
     new nanoproducts, including
     nano-sunscreens (Docket No. 2006P-2010).
      In 2008 CTA filed a similar legal
     action with the Environmental Protection
     Agency (EPA) on the unregulated
     potential environmental and health
     dangers of nano-silver consumer
     products.

     Further Resources:

     International Center for Technology
     Assessment 2008 Legal Petition to EPA on
     Regulation of Nano-silver Products,
     http://www.nanoaction.org/nanoaction/pag
     e. cfm?id=244

     Friends of the Earth, Report, Out Of The
     Laboratory And Onto Our Plate:
     Nanotechnology in Food & Agriculture
     (2008),
     http://action.foe.org/content.jsp?conten
     t_ KEY=3965&t=2007_Healthy-People.dwt,
     and http://www.foe.org/pdf/nano_food.pdf


     International Center for Technology
     Assessment 2006 Legal Petition to FDA on
     Regulation of Nanotechnology and
     Nano-Sunscreens:
     http://www.icta.org/doc/Nano%20FDA%20pet
     it ion%20final.pdf

     Petition Executive Summary:
     http://www.icta.org/doc/Nano%20petition%
     20 ex%20summary.pdf

     Friends of the Earth Report: A Consumer
     Guide for Avoiding Nano-Sunscreens
     (2007)
     http://www.foe.org/nano_sunscreens_guide
     /N ano_Sunscreens.pdf

     Friends of the Earth Report:
     Nanomaterials, Sunscreens, and
     Cosmetics: Small Ingredients Big Risks
     (2006):
     http://www.foe.org/camps/comm/nanotech/n
     an ocosmetics.pdf

     Principles for the Oversight of
     Nanotechnologies and Nanomaterials:
     http://www.icta.org/doc/Principles%20for
     %2
     0the%20Oversight%20of%20Nanotechnologies
     %2 0and%20Nanomaterials_final.pdf

     Executive Summary/Press Release of
     Principles:
     http://www.icta.org/press/release.cfm?ne
     ws _id=26

     Consumer Reports:
     http://www.consumerreports.org/cro/healt
     h-fitness/beauty-personal-care/sunscreen-7
     -0 7/overview/0707_sunscreen.htm

     Woodrow Wilson International Center for
     Scholars Project on Emerging
     Nanotechnologies - Consumer Product
     Database:
     http://www.nanotechproject.org/44



     Campaign Expiration Date:
     October 20, 2008


------ End of forwarded message -------[Mike Devour, Citizen, Patriot,
Libertarian]
[[email protected]                        ]
[Speaking only for myself...               ]


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