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FDA sued over lack of Nanotech oversight, labels - first ever lawsuit re nanotech risks

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  • Kathy Ging
    _Based on the scientific literature so far, several hundred products should be recalled due to their toxicity to lab animals and bacteria._
    Message 1 of 2 , Feb 1, 2013
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      _Based on the scientific literature so far, several hundred products should be recalled due to their toxicity to lab animals and bacteria._


      FDA sued over lack of Nanotech oversight, labels


      By radyananda

      By Rady Ananda
Activist Post

      The first ever lawsuit concerning risks of nanotechnology was filed in federal court last month when several groups jointly sued the US Food and Drug Administration for its lack of response to a 2006 petition demanding that products with nanomaterials be labeled and their effects tested for safety. [Image]

      Led by the International Center for Technology Assessment (ICTA), plaintiffs also include Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy (IATP).

      “It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,” said Wenonah Hauter, executive director of Food & Water Watch.  “It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.”

      Based on the scientific literature so far, several hundred products should be recalled due to their toxicity to lab animals and bacteria.

      Much of the 2011 complaint argues that because nanomaterials are patented, and exhibit novel characteristics unique to their size, they clearly represent new substances requiring regulation and safety tests.  Plaintiffs demand a recall on all such products until their safety is proven.

      Consumer groups including some of the same plaintiffs in the current lawsuit also filed petitions urging nanotech regulation with the Environmental Protection Agency back in 2006 and 2008, reports the Chemical Regulation Reporter.

      Nanotechnology is the science of manipulating materials on an atomic or molecular scale, measured in billionths of a meter.  Nanotech-engineered materials (NEMs) are used in food, cosmetics (including toothpaste and sunscreen), drugs, fertilizers, and home cleaning products with little regulation in the U.S.  They are found in ice cream and the coating sprayed on fruits and vegetables, and even line bottles and cans, reported Andrew Schneider in his 2010 exposé on the subject.

      NEMs are also used in industry processes and military applications including drones, combat gear and miniature devices.  The Dept. of Defense has spent billions on nanotech R&D.  Per its 2007 report, nanotech is used in “chemical and biological warfare defense; high performance materials for platforms and weapons; unprecedented information technology [like smart clothes]; revolutionary energy and energetic materials; and uninhabited vehicles and miniature satellites.”  (Also see the 2011 National Nanotechnology Initiative Strategic Plan.)

      In June 2011, both the FDA and the EPA issued draft guidelines on NEMs.  Though nano-pesticides are already on the market, the EPA made its first approval last month.  The Swiss firm, HeiQ, now sells its composite nanosilver and nano-silica for use in clothing (to reduce microbial odor) with EPA approval.

      Upon publication of the FDA’s voluntary guidlines, the Alliance for Natural Health immediately demanded that nanomaterials be banned from organic certification, as they are in Canada.

      The FDA has done nothing on NEM regulation since last June.  Prior to that, the FDA absurdly denied that any nanofoods were being sold in the U.S.

      “Not true, say some of the agency’s own safety experts, pointing to scientific studies published in food science journals, reports from foreign safety agencies and discussions in gatherings like the Institute of Food Technologists conference,” reports Schneider.

      Several of the plaintiffs have issued public reports on nanotech, including IATP.  In Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, IATP notes that as of March 2011, there were over 1,300 products known to contain NEMs.  That’s up from 200 in 2006, but the number is conservatively expected to rise to 3,400 by 2020.  The ETC Group estimates well over 1,600 products in its 2010 report, The Big Downturn? Nanogeopolitics.

      The Project on Emerging Nanotechnologies (PEN), a partnership of the Pew Charitable Trusts and the Woodrow Wilson International Center for Scholars, a U.S. government research center, notes that there is no registry of nano-scale ingredients and materials used in products or industrial processes.

      “Establishing such a registry, as well as consumer products registry,” advises IATP, “would be necessary components of the eventual regulation of nanotechnology.”


    • Mark Robinowitz
      ... Pew is the philanthropic arm of Sunoco (Sun Oil Company). They are a primary funder of the forest protection division of the foundation funded
      Message 2 of 2 , Feb 3, 2013
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        On Feb 1, 2013, at 2:01 AM Feb 1, Kathy Ging wrote:

        > The Project on Emerging Nanotechnologies (PEN), a partnership of the Pew Charitable Trusts and the Woodrow Wilson International Center for Scholars, a U.S. government research center, notes that there is no registry of nano-scale ingredients and materials used in products or industrial processes.

        Pew is the philanthropic arm of Sunoco (Sun Oil Company). They are a primary funder of the "forest protection" division of the foundation funded environmental movement. They're part of the alleged environmental representation on Dr. Kitzhaber's consensus panel about privatizing the US BLM federal forests in western Oregon (to give to timber barons for liquidation via clearcuts and herbicides).

        Wired 8.04: Why the future doesn't need us.
        By Bill Joy

        Probably the single best article on the hazards of nanotechnology (especially its confluence with robotics, genetic engineering and computation).

        Center for Responsible Nanotechnology

        Privacy Implications of Nanotechnology

        Grey goo, a term coined by nanotechnology pioneer Eric Drexler, refers to a hypothetical end-of-the-world event involving nanotechnology in which out-of-control self-replicating robots consume all life on Earth while building more of themselves (a scenario known as ecophagy). It is usually used in a science fictional context. In a worst-case scenario, all of the matter in the universe could be turned into goo (with "goo" meaning a large mass of replicating nanomachines lacking large-scale structure, which may or may not actually appear goo-like), killing the universe's residents. The disaster could result from an accidental mutation in a self-replicating nanomachine used for other purposes, or possibly from a deliberate doomsday device.
        It is unclear whether nanotechnology is capable of creating grey goo at all. Among other common refutations, theorists suggest that the very size of nanoparticles inhibits them from moving very quickly. While the biological matter that composes life releases significant amounts of energy when oxidised, and other sources of energy such as sunlight are available, this energy might not be sufficient for the robots to out-compete existing organic life that already uses those resources, especially considering how much energy they will use for locomotion. If the nanomachine is itself composed of organic molecules, then it might even find itself being preyed upon by preexisting bacteria and other natural life forms. One convenient analogy for the grey goo problem is to consider viruses as the most perfect example of nanotechnology; as they have not reduced the world to grey goo in 4 billion years of evolution, it is unlikely that some artificial construct will manage to do so.
        If they are built of inorganic compounds or make much use of elements that are not generally found in living matter, then they will need to use much of their metabolic output for fighting entropy as they purify (reduce sand to silicon, for instance) and synthesize the necessary building blocks. There would be little chemical energy available from inorganic matter such as rocks because, aside from a few exceptions (coal, for example) it's mostly well-oxidized and sitting in a free-energy minimum. Drexler has made a somewhat public effort to retract his hypothesis, in an effort to focus the debate on more realistic threats and misuses associated with knowledge-enabled nanoterrorism and other misuses.
        Because of these limitations grey goo may only be possible in an environment which lacks indigenous life to compete with it for resources. However, some proponents of nanotechnology argue that artificial nanomachines might be able to outcompete natural life because they could have irreducibly complex designs that life could not have developed via natural evolution.
        Recently, new analysis has shown that the danger of grey goo is far less likely than originally thought. However, other long-term major risks to society and the environment from nanotechnology have been identified.

        Nanotechnology has a dark side: nanoparticles shown to cause brain damage
        Monday, Jun 14, 2004
        Nanotechnology, it turns out, has a dark side that no one in the industry wants to talk about. New research suggests that nanoparticles could be harmful: fish exposed to nanoparticles duffered brain damage. Within 48 hours after being exposed to a very low concentration of nanoparticles, the fish produced brain damage that resembles Alzheimer's disease. But you won't hear that from the people involved in nanotech -- which seems to be anybody who wants a grant these days -- because they only want you to hear about the good news, not the bad.
        There's not much good news, though: nanotechnology has so far been little more than hype. In fact, nobody can even agree on what nanotech really is. As the saying goes in the industry, "Nano is anything that I'm working on, but nothing that you're working on." Frankly, just about anything can be called nano, and if you scan the nanotech headlines these days, you'll see what I'm talking about.

        Original News Summary
        Big Concern for Very Small Things
        Click to read the full story at www.wired.com

        - The nascent nanotechnology industry collectively cringed last week after a study showed that fish exposed to nanoparticles suffered brain damage.
        - Critics say the much-hyped multibillion-dollar nano industry has a dark side few want to talk about.
        - Nano products are not subject to any special regulations, in part because little is known about the environmental and health implications of nanotechnology, says Kevin Ausman, executive director of the Center for Biological and Environmental Nanotechnology at Rice University in Houston.
        - To see what might happen if buckyballs got into the environment, Eva Oberd-rster, an aquatic scientist at Southern Methodist University, put some into a fish tank at a concentration of 0.5 parts per million, along with nine largemouth bass.

        Nanotechnology in food - links to several articles

        Nanotech battle suit under development
        Posted by: admin
        The quest to create a futuristic battle suit, one micron at a time
        New institute in Boston, which develops defense technologies, reflects shift in the region's economy.
        By Abraham McLaughlin | Staff writer of The Christian Science Monitor

        Deep inside the labyrinthine hallways of the world-renowned Massachusetts Institute of Technology, in a quiet laboratory with pristine linoleum floors, two students are hunched over a compressing machine the size of a small refrigerator.
        Suddenly a loud pop pierces the air. Lauren Frick, an MIT senior, yelps, as small white shards spatter across her hand.
        But it's hardly cause for concern. She and fellow researcher Benjamin Bruet are testing the strength of seashells. Their aim: to help create a futuristic "battle suit" for America's soldiers that's as thin as a scuba diver's wet suit - but fit for a superhero. Among other things, it would be bulletproof and help soldiers leap 20-foot walls.
        Their work is part of a unique new venture called the Institute for Soldier Nanotechnology (ISN). It's a collaboration between the US Army, MIT, defense contractors, and the medical industry.
        The institute represents a fusion of realms in a city that's a national hub for big ideas in a growing number of fields. And it reflects tectonic shifts in the region's economic character.
        Amid growing military spending - especially on futuristic weapons - the center of gravity for the region's defense industry is shifting from building behemoths, like ships, to high-tech research. Meanwhile, the region's biotech sector is expanding. And medical complexes dominate the Northeast landscape more than ever.
        The ISN is "a very different kind of collaboration," says Andre Mayer, president of the New England Economic Project. "It isn't entirely new for some of these players. But it's a new wave and a new kind of focus."
        Collaboration between the military and Boston's mega-watt academic minds is nothing new. Researchers at MIT perfected radar for military use during World War II.
        But nano-technology is a whole new world. It's the science of objects far smaller than the width of a human hair.
        For instance, when Ms. Frick and Mr. Bruet use scanning-electron microscopes or atomic-force microscopes to look at the seashells, they see what looks like a wall of bricks. The "bricks" are five microns long and one micron tall. (A human hair is 80 microns wide.)
        Nature, they explain, has taken relatively weak materials and created a structure - the brick wall - that is impressively tough. Using nano-construction techniques, the ISN will eventually try to mimic that structure with super-strong materials, thus creating a lightweight - and bulletproof - substance.
        But first ISN researchers are testing the toughness of many natural materials - everything from antlers to armadillo shells to horse hoofs.
        They even tried to get dinosaur plates from Norway - but couldn't get export permits. And Bruet convinced a paleontologist in Paris to give him a prehistoric armored fish from Senegal. Bruet hand-carried it back to Boston for testing.
        "We're going to try to find nature's toughest material," says Frick, a material-science major.
        And these researchers are not the only ones looking. When ISN is fully staffed, it will have some 35 faculty members; 80 graduate students; and specialists from Raytheon, the DuPont chemical company, two Boston hospitals, and others.
        Together, they're working on a range of projects. One would create "exo-muscles" embedded in the battle suit. These would give soldiers Spider-Man-like strength. But ISN Director Ned Thomas admits it's probably years from reality.
        He tells of a recent show-and-tell session with an Army general. A nano-model - shaped like a human hand - was expanding and retracting. Scientists saw it as an impressive display of nano-mechanics. But, recalls Dr. Thomas, "The general said, 'Call me when it can crush rocks.' "
        Even if scientists can create a nano-muscle, they will have to figure out how to enable it to work alongside real muscles.
        Another project - which involves medical researchers - would include nano-sized bioweapons sensors. When the battle suit detected chemical weapons it would close up a system of "pores" that would keep toxins away from the soldier.
        Indeed, the beauty of nano-tech, Thomas explains, is that it can include multiple functions all woven into a fabric as thin as a wet suit.
        But, for now the ISN has more realistic aims. When Thomas interviewed soldiers at an Army training facility, he asked what improvements they most wanted. "They told us they wanted to waterproof everything - everything," he says.
        They already lug up to 140 pounds of gear around the battlefield, he explains. When it gets wet, it's even heavier. So, one of ISN's short-term projects is a waterproof microcoating that could be applied to any material.
        from the June 10, 2003 edition - http://www.csmonitor.com/2003/0610/p02s01-usgn.html

        April 28, 2005
        Published May 5, 2005
        Nanotechnology and the Precautionary Principle
        By Peter Montague
        Nanotechnology -- or nanotech, for short -- is a new approach
        to industrial production, based on the manipulation of things
        so small that they are invisible to the naked eye and even to
        most microscopes.
        Nanotech is named for the nanometer, a unit of measure, a
        billionth of a meter, one one-thousandth of a micrometer. The
        Oxford English Dictionary defines nanotechnology as "the branch
        of technology that deals with dimensions and tolerances of less
        than 100 nanometers, especially the manipulation of individual
        atoms and molecules." Nanotech deals in the realm where a
        typical grain of sand is huge (a million nanometers in
        diameter). A human hair is 200,000 nanometers thick. A red
        blood cell spans 10,000 nanometers. A virus measures 100
        nanometers across, and the smallest atom (hydrogen) spans 0.1
        In the realm below 50 nanometers, the normal laws of physics no
        longer apply, quantum physics kicks in and materials take on
        surprising new properties. Something that was red may now be
        green; metals may become translucent and thus invisible;
        something that could not conduct electricity may now pass a
        current; nonmagnetic materials may become magnetized; insoluble
        substances may dissolve. Knowing the properties of a substance
        in bulk tells you nothing about its properties at the nano
        scale, so all nano materials' characteristics -- including
        hazardous traits -- must be learned anew by direct experiment.
        Nanotechnologists foresee a second industrial revolution
        sweeping the world during our lifetimes as individual atoms are
        assembled together into thousands of useful new products. Few
        deny that new products may entail new hazards, but most
        nanotechnologists say existing regulations are adequate for
        controlling any hazards that may arise. In the United States,
        nanotech is not now subject to any special regulations and nano
        products need not even be labeled. Furthermore, no one has
        developed a consistent nomenclature for nano materials, so
        rigorous discussion of nanotech among regulators and
        policymakers is not yet possible. Without consistent
        nomenclature, standardized safety testing lies in the future.
        No one denies that nanotech will produce real benefits, but,
        based on the history of nuclear power, biotechnology and the
        chemical industry, skeptics are calling for a precautionary
        approach. The resulting clash of philosophies -- "Better safe
        than sorry" versus "Nothing ventured, nothing gained" or even
        in some cases "Damn the torpedoes, full speed ahead!" -- may
        offer a major test of the Precautionary Principle as a new way
        of managing innovation.
        The pressure for rapid development of nanotech is enormous. The
        surprising properties of materials at the nano scale have
        opened up a new universe of industrial applications and
        entrepreneurial dreams. Largely unnoticed, hundreds of products
        containing nano-sized particles have already reached the market
        -- metal surfaces and paints so slick they clean themselves
        when it rains; organic light-emitting diodes for computer
        screens, digital cameras and cell phones; sub- miniature data
        storage devices (aiming to hold the Library of Congress in a
        computer the size of a sugar cube); specialty lubricants; long-
        mileage vehicle tires; nano-reinforced plastics for stronger
        automobile fenders; light-weight military armor;
        anti-reflective and scratch-resistant sun glasses;
        super-slippery ski wax; powerful tennis rackets and
        long-lasting tennis balls; inkjet photographic paper intended
        to hold an image for 100 years; high-contrast MRI scanners for
        medical diagnosis; efficient drug and vaccine delivery systems;
        vitamins in a spray; invisible sunscreen ointments containing
        nano particles of titanium or zinc; anti-wrinkle cosmetic
        creams; and so on.
        And this is just the beginning. Nanotech wasn't possible until
        the invention in the 1980s and early 1990s of ways to arrange
        individual atoms under software control. Nano particles,
        nanotubes and carbon nano crystals called Bucky Balls (after
        Buckminster Fuller) are now being manufactured in ton
        quantities for industrial use. Currently technologists are
        working feverishly to coax nature's most successful nano
        factory, the living cell, to grow useful new nano assemblies.
        It is no exaggeration to say that the field of nanotech is
        gripped by something approaching a gold rush mentality.
        Worldwide, governments are spending an estimated $3 billion per
        year on nanotech research, and the private sector is thought to
        be spending at least that much. The U.S. government alone will
        spend at least $3.7 billion on nano R&D during the next four
        years. The global market for nano products is expected to reach
        $1 trillion in 10 years or less. Any day of the week you can
        check in at http://nanotech-now.com and catch a glimpse of the
        gold rush in action.
        But for some prominent proponents of nanotech, this is about
        more than money -- it is about reinventing the entire world,
        including humans, as they now exist. According to the U.S.
        National Science Foundation, nanotechnology is the foundation
        stone of NBIC -- a revolutionary convergence of nanotech,
        biotech (manipulation of genes), info tech (computers), and
        cogno tech (brain function). In a report sponsored by the
        National Science Foundation and the Department of Commerce, the
        technologists and politicians who are promoting this revolution
        say it is "essential to the future of humanity" because it
        holds the promise of "world peace, universal prosperity, and
        evolution to a higher level of compassion and accomplishment."
        They say it may be "a watershed in history to rank with the
        invention of agriculture and the Industrial Revolution." The
        ultimate aim of this revolution has been an explicit human goal
        for at least 400 years -- the "conquest of nature" and the
        enhancement of human capabilities.
        Whatever else it may offer, the nanotech revolution entails a
        radical new approach to industrial production with the
        potential to change every existing industry, plus create new
        ones. Typical manufacturing today -- even construction of the
        tiniest computer circuit -- relies on "top-down" techniques,
        machining or etching products out of blocks of raw material.
        For example, a common technique for making a transistor begins
        with a chunk of silicon, which is etched to remove unwanted
        material, leaving behind a sculpted circuit. This "top-down"
        method of construction creates the desired product plus waste
        In contrast, nanotech makes possible "bottom-up" construction
        in which atoms are arranged under software control -- or in
        ideal cases they will self-assemble, just as living cells
        self-assemble -- into the desired configuration with nothing
        left over, no waste. Instead of cutting trees into lumber to
        make a table, why not just "grow" a table? Thus nanotech seems
        to offer the possibility of waste-free manufacturing and
        therefore a cleaner environment. Furthermore, nanotech may help
        remediate past pollution. U.S. Environmental Protection Agency
        (EPA) is funding research on releasing nano particles into the
        environment to detoxify mountains of toxic waste remaining from
        the 20th century's experiment with petroleum-based chemistry.
        Nevertheless, without denying plausible benefits, critics want
        nanotech's potential problems brought into the open:
        ** Unless nanotechnology is shared generously, it may create a
        "nano divide" similar to the "digital divide" that exists now
        between those with ready access to computers and those without.
        ** Humans given enhanced mental or physical capabilities may
        gain great advantage over normal people. On the other hand,
        some people may be coerced to accept dubious or unwanted
        ** Inequalities within and between nations may be exacerbated
        if individuals and corporations gain monopoly control of
        nanotech by patenting the building blocks of the universe -- a
        precedent set in 1964 when Glenn T. Seaborg was issued a patent
        on an element he discovered and named Americium.
        In the longer term, some leading technologists like Ray
        Kurzweil, inventor of the first reading machine for the blind,
        and Bill Joy, one of the founders of Sun Microsystems, fear
        that nanotech will give individuals -- inadvertently or
        intentionally -- destructive potential greater than the power
        of atomic weapons. As Joy wrote in 2000, "I think it is no
        exaggeration to say we are on the cusp of the further
        perfection of extreme evil, an evil whose possibility spreads
        well beyond that which weapons of mass destruction bequeathed
        to the nation-states, on to a surprising and terrible
        empowerment of extreme individuals."
        Others, such as the insurance industry, have more mundane
        concerns about nanotech -- chiefly, the potential health and
        environmental hazards of tiny particles. In May of 2004, Swiss
        Re, the world's second-largest reinsurance firm, issued a
        report calling for the Precautionary Principle to guide
        nanotech development. Swiss Re itemized a host of potential
        problems that it says need to be resolved before nanotech
        products are fully deployed, including these:
        ** One of the new properties of nano-sized particles is their
        extreme mobility. They have "almost unrestricted access to the
        human body," Swiss Re points out, because they can enter the
        blood stream through the lungs and possibly through the skin,
        and seem to enter the brain directly via olfactory nerves. Once
        in the blood stream, nano particles can "move practically
        unhindered through the entire body," unlike larger particles
        that are trapped and removed by various protective mechanisms.
        ** If they become airborne, nano particles can float for very
        long periods because -- unlike larger particles -- they do not
        readily settle onto surfaces. In water, nano particles spread
        unhindered and pass through most available filters. So, for
        example, current drinking water filters will not effectively
        remove nano particles. Even in soil, nano particles may move in
        unexpected ways, perhaps penetrating the roots of plants and
        thus entering the food chains of humans and animals.
        ** One of the most useful features of nano particles is their
        huge surface area. The smaller the particle, the larger its
        surface in relation to its mass. A gram of nano particles has a
        surface area of a thousand square meters. Their large surfaces
        give nano particles some of their most desirable
        characteristics. For example, drug-coated nano particles may
        one day transport pharmaceuticals directly to specific sites
        within the human body. Unfortunately, their large surface also
        means that nano particles may collect and transport pollutants.
        Furthermore, their large surface means nano particles are
        highly reactive in a chemical sense. As Swiss Re noted, "As
        size decreases and reactivity increases, harmful effects may be
        intensified, and normally harmless substances may assume
        hazardous characteristics." Nano particles may harm living
        tissue, such as lungs, in at least two ways -- through normal
        effects of chemical reactivity, or by damaging phagocytes,
        which are scavenger cells that normally remove foreign
        substances. Phagocytes can become "overloaded" by nano
        particles and cease functioning. Worse, overloaded phagocytes
        retreat into deeper layers and so become unavailable to protect
        against foreign invaders. Successive particles are then able to
        do their full reactive damage, and other invaders, such as
        bacteria, may penetrate unhindered. The surface reactivity of
        nano particles gives rise to "free radicals," which are atoms
        containing an "unsatisfactory" number of electrons (either too
        few or too many for stability). Free radicals swap electrons
        with nearby atoms, creating further instabilities and setting
        off a cascade of effects. Free radicals give rise to
        inflammation and tissue damage, and may initiate serious harm,
        such as growth of tumors. On the other hand, some free radicals
        are beneficial, destroying invaders. So the role of nano
        particles in producing free radicals remains to be clarified.
        ** Nano particles would normally tend to clump together,
        forming larger, less dangerous particles -- but
        nanotechnologists take pains to prevent clumping by adding
        special coatings. As a result, nano particles in many
        commercial products, sprays and powders remain reactive and
        highly mobile.
        ** Whether nano particles can pass through the skin into the
        blood stream is the subject of intense debate. Different
        experiments have yielded conflicting results, presumably
        because test protocols have not been standardized. Some believe
        that nano particles may slip between the layers of outer skin
        and penetrate through to the blood below. Others believe that
        hair follicles offer a direct route for nano particles to
        penetrate from skin to blood. No one knows for sure. Despite
        this knowledge gap, sun screens, skin lotions and baby products
        containing nano particles are already on the market. Clearly
        this is a problem for insurance firms providing liability
        coverage. Swiss Re says, "Considering the wide variety of
        products already on the market, the need for a solution is
        ** Ingested nano particles can be absorbed through "Peyer's
        plaques," part of the immune system lining the intestines. From
        there, nano particles can enter the blood stream, be
        transported throughout the body, "and behave in ways that may
        be detrimental to the organism," Swiss Re notes. While in the
        blood stream, nano particles have been observed entering the
        blood cells themselves.
        ** Once in the body, nano particles can enter the heart, bone
        marrow, ovaries, muscles, brain, liver, spleen and lymph nodes.
        During pregnancy, nano particles would likely cross the
        placenta and enter the fetus. The specific effects in any given
        organ would depend upon the surface chemistry of particular
        particles, which in turn would be determined by their size and
        surface coating. "It is likely that in the course of its entire
        evolution, humankind has never been exposed to such a wide
        variety of substances that can penetrate the human body
        apparently unhindered," Swiss Re says.
        ** The brain is one of the best-protected of all human organs.
        A guardian "blood-brain barrier" prevents most substances in
        the blood from entering the brain (alcohol and caffeine being
        two well-known exceptions). However, nano particles have
        repeatedly been shown to pass into the brain, where their
        effects are unknown. Will they accumulate and, if so, to what
        ** Nano particles may disrupt the immune system, cause allergic
        reactions, interfere with essential signals sent between
        neighboring cells, or disrupt exchanges between enzymes, Swiss
        Re says. Some of these characteristics may be harnessed for
        benefit -- for example, in experiments a carbon nano crystal
        has been able to disrupt one of the processes that allows the
        AIDS virus to multiply.
        ** Nano particles in disposable products will eventually enter
        the environment. In the environment, nano particles represent
        an entirely new class of pollutants with which scientists (and
        nature) have no experience. Swiss Re speculates that, "Via the
        water cycle, nano particles could spread rapidly all over the
        globe, possibly also promoting the transport of pollutants."
        Swiss Re asks, "What would happen if certain nanoparticles did
        exert a harmful influence on the environment? Would it be
        possible to withdraw them from circulation? Would there be any
        way of removing nanoparticles from the water, earth, or air?"
        ** Turning to workplace hazards, Swiss Re asks whether nano
        particles will become the next asbestos. To protect workers,
        effective face masks are "not a very realistic prospect at
        present, since the requisite design would render normal
        breathing impossible." New designs may be possible but remain
        Swiss Re notes that, in the past, the drive toward rapid
        technological innovation has "prevented the introduction of the
        Precautionary Principle in relation to new technologies for
        more than 20 years." But now, "in view of the dangers to
        society that could arise out of the establishment of
        nanotechnology, and given the uncertainty currently prevailing
        in scientific circles, the Precautionary Principle should be
        applied whatever the difficulties," Swiss Re asserts. "The
        Precautionary Principle demands the proactive introduction of
        protective measures in the face of possible risks, which
        science at present -- in the absence of knowledge -- can
        neither confirm nor reject."
        What would precaution look like in a rapidly developing field
        like nanotech? The British Royal Society and the Royal Academy
        of Engineering issued a nanotech report in July 2004
        recommending a series of precautionary actions, with the
        following chain of reasoning:
        ** "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."
        These recommendations reverse the traditional approach to
        industrial materials, which have historically been assumed
        benign until shown otherwise.
        The Royal Society puts the burden of producing information
        about safety on industry, not on the public: "A wide range of
        uses for nanotubes and nanoparticles is envisaged that will fix
        them within products.... We believe that the onus should be on
        industry to assess ... releases [of nano particles from
        products] throughout a product's lifetime (including at the
        end-of-life) and to make that information available to the
        regulator." From such a recommendation, it is a very short step
        to the European Union's precautionary proposal for industrial
        chemicals, called REACH (Registration, Evaluation and
        Authorization of Chemicals), which is often summarized as, "No
        data, no market."
        The Royal Society recommended that the use of zinc oxide nano
        particles and iron oxide nano particles in cosmetics should
        "await a safety assessment" -- in other words a moratorium on
        these products is recommended. Likewise, "the release of free
        manufactured nanoparticles into the environment for [pollution]
        remediation (which has been piloted in the USA) should be
        prohibited until there is sufficient information to allow the
        potential risks to be evaluated as well as the benefits."
        The Precautionary Principle is sometimes called the foresight
        principle. Importantly, the Royal Society's report fully
        embraces foresight for nanotechnology (and all other new
        technologies): "Our study has identified important issues that
        need to be addressed with some urgency" and so it is
        "essential" for government to "establish a group that brings
        together representatives of a wide range of stakeholders to
        look at new and emerging technologies and identify at the
        earliest possible stage areas where potential health, safety,
        environmental, social, ethical and regulatory issues may arise
        and advise about how these might be addressed." The group must
        provide "an early warning of areas where regulation may be
        inadequate for specific applications of these technologies."
        And, finally, "The work of this group should be made public so
        that all stakeholders can be encouraged to engage with the
        emerging issues."
        Thus nanotech is sparking not only a new industrial revolution
        but demands for a reversal of traditional approaches to
        managing innovation and a turn toward precautionary action.
        Whether the momentum gathering behind the precautionary
        approach can redirect the charge behind nanotech -- a
        confluence of government and technophile advocates in alliance
        with an emerging industrial lobby -- remains uncertain.
        This article originally appeared in The Multinational Monitor
        Vol. 25, No. 9 (September, 2004), pgs. 16-19, under the title,
        "Welcome to NanoWorld: Nanotechnology and the Precautionary
        Principle Imperative."
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