Rachel's Democracy & Health News #855  [Printer-friendly version]
May 18, 2006


[Rachel's introduction: Eight public interest groups are forcing the
Food and Drug Administration (FDA) to confront the reality that
nanotechnology creates products that may be useful but may also be
quite dangerous. Up to now, the FDA has kept its head in the sand on
this issue, pretending there's no problem. Time for a major showdown.]

By Tim Montague

Just in time for summer, a group of eight environmental and public
interest groups have petitioned the U.S. Food and Drug Administration
(FDA) to recall nanotech sunscreens from supermarket shelves. This
will force FDA to finally decide whether nano particles are something
radically new or not.

Nano particles are named for their small size (a nanometer is a
billionth of a meter), and nano particles are smaller than anything
humans have ever put into commercial products before. Their tiny size
changes their characteristics completely. If they didn't represent
something new, they wouldn't have the commercial world excited. At
present something like a goldrush mentality surrounds nanotech.

Friends of the Earth, Greenpeace and the International Center for
Technology Assessment on May 17 demanded of FDA "that nanoparticles be
treated as new substances; nanomaterials be subjected to nano-specific
paradigms of health and safety testing; and that nanomaterial products
be labeled to delineate all nanoparticle ingredients." In other words,
they are asking the FDA to wake up to the consensus of respected
scientific bodies like the British Royal Society who concluded in
their 2004 report that nano particles are different from anything
humans have ever created before and that we need to take a
precautionary approach.

The petition to FDA says, "Engineered nanoparticles have fundamentally
different properties from their bulk material counterparts --
properties that also create unique human health and environmental
risks -- which necessitate new health and safety testing paradigms."
And this is confirmed by scientists like Gunter Oberdorster who has
written text books on the subject and a recent review of
'nanotoxicology'. Until now, FDA (like U.S. Environmental Protection
Agency and the Occupational Safety and Health Administration) have
remained oblivious to all nanotech health risks. Their position is
that carbon is carbon regardless of the size of its particles, zinc is
zinc, and titanium is titanium. Size does not matter, says FDA.

But every physicist knows that size matters a great deal. The smaller
an object is, the larger its surface is in relation to its volume.
Thus nano particles have an enormous surface to volume ratio, which
renders them biologically active. Oberdorster says, "This increased
biologic activity can be either positive and desirable (e.g.,
antioxidant activity, carrier capacity for therapeutics, penetration
of cellular barriers for drug delivery) or negative and undesirable
(e.g., toxicity, induction of oxidative stress or of cellular
dysfunction), or a mix of both."

Now public interest organizations are asking the FDA to "Declare all
currently available sunscreen drug products containing engineered
nanoparticles of zinc oxide and titanium dioxide as an imminent hazard
to public health." The petition (2.8 MB) and a related report (4
MB) by Friends of the Earth (FOE) expose the dark underbelly of the
health and beauty industry that has joined the nanotech gold rush
without much thought for the short or long term consequences to nature
or human health. But how could they? The structure of the modern
corporation doesn't allow for ethical perspectives or precautionary
action if they might significantly limit the bottom line.

Next time you (or your kids) want to slather up with your favorite
sunblock, remember that the active ingredient in the sunscreen --
typically zinc oxide and/or titanium dioxide -- could very well be a
nanomaterial. There are now hundreds of sunscreens, moisturizers,
cosmetics and other personal care products containing sub-microscopic
materials that we simply don't understand. And because the FDA doesn't
require labeling, consumers are left in the dark -- a vast experiment
with only one winner, and that isn't you or me.

We aren't talking about the same zinc oxide that you knew as a youth
on lifeguard's noses. Nanoscale engineered materials (smaller than 100
nanometers in diameter -- iron, aluminum, zinc, carbon, and many
others) are measured in billionths of a meter. A human hair is 80,000
nanometers wide. A strand of DNA is 3.5 nm across. The nanoworld is
quite a different place -- a world where particles can pass directly
from the environment into your bloodstream, tissues, cells and
organelles. The nano revolution has burst upon us for just that reason
-- nanomaterials take on new and unique properties that make them
attractive as drug delivery vehicles, chemical sponges and nano-robot
("nanobot") building blocks.

There are three typical ways in which nanomaterials get into our
bodies -- we breath them, ingest them or absorb them through our skin.
And despite the evidence that nanomaterials cause lung, liver and
brain damage in animals, our Food and Drug Administration (FDA) is
treating nanomaterials like their standard or bulk sized counterparts
of yesteryear.

In March, 2006, Jennifer Sass of the Natural Resources Defense Council
(NRDC) summarized the state of regulatory affairs for nanotechnology
thus: "The Toxic Substances Control Act is the most obvious law for
regulating nanomaterials. But the law does not require manufacturers
to provide safety data before registering a chemical, instead placing
the burden on the government to demonstrate that a substance is
harmful. If the government does not follow up on potential risks with
a new product application within several months, the company can
proceed to sell its product. Other laws on the books also are
inadequate. The Food, Drug and Cosmetic Act [giving FDA regulatory
power] includes only feeble safeguards for cosmetics, which already
promise to be a major use of nanomaterials. Likewise, the poorly
enforced Occupational Safety and Health Act fails to address nano-
specific worker protections."

As we reported in Rachel's #816, the British Royal Society
(approximately the equivalent of our National Academy of Sciences)
issued a report in July 2004 recommending a series of precautionary
actions based on their review of the scientific literature on the
possible health effects of nanomaterials:

** "The evidence we have reviewed suggests that some manufactured
nanoparticles and nanotubes are likely to be more toxic per unit mass
than particles of the same chemicals at larger size and will therefore
present a greater hazard."

** "There is virtually no evidence available to allow the potential
environmental impacts of nanoparticles and nanotubes to be evaluated."

** Therefore, "the release of nanoparticles to the environment [should
be] minimized until these uncertainties are reduced."

** And, "until there is evidence to the contrary, factories and
research laboratories should treat manufactured nanoparticles and
nanotubes as if they were hazardous and seek to reduce them as far as
possible from waste streams."

At the heart of the health and safety concerns is the tendency for
nanoparticles like fullerenes, nanotubes, and nanoparticle metal
oxides to produce free radicals -- charged atoms that are highly
reactive and which can cause oxidative stress, inflammation, and
subsequent damage to cells and tissue. A recent study by Duke
University found that fullerenes (Buckyballs) cause brain damage in
large mouth bass.

The FOE report says "Because of their size, nanoparticles are more
readily taken up by the human body than larger sized particles and are
able to cross biological membranes and access cells, tissues and
organs that larger sized particles normally cannot." Once in the blood
stream, nanomaterials can affect all of the organs and tissues of the
body including the bone marrow, heart, lungs, brain, liver, spleen and
kidneys. But little is known about what dose may cause harmful effects
or how long different nanomaterials remain in various tissues.

It is known that nanoparticles can inhibit the growth of and kill
kidney cells. At the cellular level, unlike larger particles,
nanomaterials can pass into organelles like the mitochondria -- the
power plant of the cell -- and cell nucleus where they can cause DNA
mutation and cell death.[1 p. 7]

Nanoparticles of titanium dioxide and zinc oxide -- widely used in
sunscreens and cosmetics -- are photo active, "producing free radicals
and causing DNA damage to human skin cells when exposed to UV
light."[1 p.7] Although there is conflicting data on just how much
nanoparticles can actually penetrate human skin and enter our blood,
there is no doubt that what we put on our skin will end up in our air,
food, and water. A recent report in Environmental Science &
Technology found fish throughout Europe are contaminated with UV-
filter-chemicals -- from sunscreen -- (4-methylbenzylidene camphor or
4-MBC; and octocrylene or OC) which are known hormone disruptors. What
we rub on our bodies washes into the lakes and rivers, and then gets
into the food chain.

Even nanotech industry professionals themselves are skeptical about
the safety of these materials. Speaking about the incorporation of
fullerenes into skin-care products, Professor Robert Curl Jr. -- who
shared the 1996 Nobel Prize in Chemistry for his co-discovery of
fullerenes -- expressed concern: "I would take the conservative path
of avoiding using such cosmetics while withholding judgment on the
actual merits or demerits of their use."

And when a scientist at an international nanotoxicology meeting asked
200 of her colleagues whether they would feel comfortable using face
cream that contained fullerenes, fewer than ten indicated that they
would.[1 p.8]

The scientists who specialize in nano materials don't trust the stuff,
yet thousands of workers and consumers are being exposed every day in
the manufacture, transport and application of skin care and many other
products from tires to computer hard drives and skis.

There is very little known about current levels of workplace exposure.
The US National Science Foundation estimates that by 2015 2 million
workers worldwide will be directly employed in nanotechnology
industries. This means the total number of exposed workers will
certainly be much larger.[1 p. 10]

While the evidence continues to pile up that nanomaterials pose
significant health risks to consumers and workers, the federal
bureaucracy turns a blind eye concerned mostly with fostering economic
growth at all cost. Of the "$1.3 billion budget for the US National
Nanotechnology Initiative, only $38.5 million (less than 4%) was
earmarked for the study of the health, safety and environmental
impacts of nanotechnology. Conversely, the US Department of Defense
received $436 million (33.5% of the nanotechnology budget)." We are
spending more than ten times as much on nanotech warfare technology as
we are investing on basic health and safety research.

By their nature, corporations cannot regulate themselves -- by law
they are only allowed to do one thing: return a decent profit to
investors using every legal means available. But judging from the
chemical, nuclear and biotechnology industries, government is not up
to the task of regulating corporations to protect human health. So,
while our tax dollars are doing relatively little to bring health and
safety research into the public domain, corporations are ploughing
forward, constrained only by consumer tastes and trends. We don't want
a visible white paste on our bodies (nanomaterials help the sunscreen
disappear fast), therefore we must want nanotech.

Now public health advocates are calling for a "moratorium on the
commercialization of nanoproducts until the necessary safety research
has been conducted." And they specifically call on a precautionary
approach which shifts the burden of proof onto industry to demonstrate
product safety, calls for product labeling and transparent peer-
reviewed health and safety studies that become part of the public

In March 2006 the EPA issued 'voluntary' reporting guidelines (you've
heard this one before) which give no incentive to industry to invest
in product safety research much less reveal what little they may
actually know about the health effects of their nano-products. Time
and time again -- remember tobacco, asbestos, and lead? -- the profit
motive will always drive corporations to release products into the
market (our air, food, water and soil) even if they know the product
is dangerous to human health and the environment.

As reported in Rachel's #816, the insurance industry is deeply
concerned about the environmental and health effects of these largely
untested technologies. They understand that nanomaterials could be the
next asbestos liability debacle. It would be interesting to see a full
cost accounting (see Rachel's #765) of the potential benefits and
costs not only to industry but to the public that currently shoulders
the burden of proof with their tax dollars, endangered health and
degraded environment.

As the pharmaceutical industry has demonstrated -- operating within a
precautionary framework -- a better safe than sorry approach can work
for investors and consumers alike. Big pharma has been hugely
succesful under a system that demands precautionary pre-market testing
-- so successful that it's now under constant attack for using its
financial influence to corrupt the regulatory system. When industry
and the current regulatory agencies tell us they fear a precautionary
approach will 'stifle innovation', they really don't have a leg to
stand on.

In the meantime, I'll be heading for the fantasy nano-free section of
my supermarket for some non-nano sunscreen.

[1] Nanomaterials, sunscreens and cosmetics: small ingredients big
risks. Friends of the Earth, Washington, D.C. May 17, 2006 available
here and at www.foe.org