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Contents
-
FDA Approves First Use Of
Viruses As A 'Food Additive'
-
Nanotech Food Ten
TimesScarier Than GM Food
-
FDA Told To Watch Nanotech
Products For Risks
-
First Nano-Based Food
Industry Products Quietly Enters Market
-
Open Letter To FDA: Stop
Putting Nanoparticles In Food
-
FDA Is Non 'Nano-Ready'
-
Nanotechnology Risks Unknown
Agency Approves First Use of Viruses as a Food Additive
by THE ASSOCIATED PRESS
Published: August 19, 2006
WASHINGTON, Aug. 18 (AP) ? A mix of bacteria-killing viruses may be
sprayed on cold cuts, wieners and sausages to combat common microbes
that kill hundreds of people a year, federal health officials ruled
Friday.
The ruling, by the Food and Drug Administration, is the first
approval of viruses as a food additive, said Andrew Zajac of the
Office of Food Additive Safety at the agency.
Treatments that use bacteriophages to attack harmful bacteria have
been a part of folk medicine for hundreds of years in India and for
decades in the former Soviet Union.
The approved mix of six viruses is intended to be sprayed onto
ready-to-eat meat and poultry products, including sliced ham and
turkey, said John Vazzana, the president and chief executive of
Intralytix, which developed the additive.
The viruses, called bacteriophages, are meant to kill strains of the
Listeria monocytogenes bacterium, the food agency said.
The bacterium can cause a serious infection called listeriosis,
primarily in pregnant women, newborns and adults with weakened
immune systems. In the United States, an estimated 2,500 people
become seriously ill with listeriosis each year, according to the
federal Centers for Disease Control and Prevention. Of those, 500
die.
Luncheon meats are particularly vulnerable to Listeria because after
they are bought they are typically not cooked or reheated, which can
kill harmful bacteria like Listeria, Mr. Zajac said.
The preparation of bacteriophages - the name is from the Greek for
'bacteria eater' - attacks only strains of the Listeria bacterium
and not human or plant cells, the food agency said.
"As long as it used in accordance with the regulations, we have
concluded it's safe," Mr. Zajac said.
People normally come into contact with
bacteriophages through food,
water and the environment, and they are found in our digestive
tracts, the agency said.
Consumers will not be aware which meat and poultry products have
been treated with the spray, Mr. Zajac said. The Department of
Agriculture will regulate the actual use of the product.
The viruses are grown in a preparation of the very bacteria they
kill, and then purified. The food agency had concerns that the virus
preparation could contain toxic residues from the bacteria, but
testing did not reveal residues, which in small quantities are not
likely to cause health problems anyway, the agency said.
"The F.D.A. is applying one of the toughest food-safety standards
which they have to find this is safe," said Caroline Smith DeWaal,
director of food safety for the Center for Science in the Public
Interest, a consumer advocacy group. "They couldn't approve this
product if they had questions about its safety."
Intralytix, based in Baltimore, first petitioned the food agency in
2002 to allow the viruses to be used as an additive. It has since
licensed the product to a multinational company, which intends to
market it worldwide, Mr. Vazzana said.
Back to Contents
Nanotech Food is Ten Times
Scarier Than Genetically Engineered
Engineering Food at Level of Molecules
by Barnaby J. Feder
The New York Times, Oct 10, 2006
Straight to the Source
What if the candy maker Mars could come up with an additive to the
coating of its M&M's and Skittles that would keep them fresher
longer and inhibit melting? Or if scientists at Unilever could
shrink the fat particles (and thereby the calories) in premium ice
cream without sacrificing its taste and feel?
Tastes Like Nanotechnology
These ideas are still laboratory dreams. The common thread in these
research projects and in product development at many other food
companies is nanotechnology, the name for a growing number of
techniques for manipulating matter in dimensions as small as single
molecules.
Food companies remain wary of pushing the technology - which is
named for the nanometer, or a billionth of a meter - too far and too
fast for safety-conscious consumers. But they are tantalized by
nanotechnology's capacity to create valuable and sometimes novel
forms of everyday substances, like food ingredients and packaging
materials, simply by reducing them to sizes that once seemed
unimaginable.
Most of the hoopla and a lot of the promise for nanotechnology lies
in other industries, including electronics, energy and medicine. But
the first generation of nanotechnology-based food industry products,
including synthetic food colorings, frying oil preservatives and
packaging coated with antimicrobial agents, has quietly entered the
market.
The commercial uses of the technology now add up to a $410 million
sliver of the $3 trillion global food market, according to
Cientifica, a British market research firm that specializes in
nanotechnology coverage. Cientifica forecasts that nanotechnology's
share will grow to $5.8 billion by 2012, as other uses for it are
developed.
Mindful of the adverse reaction from some consumers over the
introduction of genetically engineered crops, the food industry
hopes regulators will come up with supportive guidelines that will
also allay consumers' fears. That has put a spotlight on the Food
and Drug Administration's first public hearing today on how it
should regulate nanotechnology, with a portion of the agenda
specifically about food and food additives. No policy changes are
expected this year.
"To their credit, the F.D.A. is trying to get a handle on what's out
there," said Michael K. Hansen, senior scientist at Consumers Union,
one of 30 groups that have signed up to speak at the meeting.
But coping with nanotechnology will be a daunting challenge for the
agency, according to a report last week by a former senior F.D.A.
official, whose analysis was sponsored by the Pew Charitable Trusts
and the Woodrow Wilson International Center for Scholars, a
Washington policy group. Michael R. Taylor, a former deputy
commissioner for policy at the agency, said the F.D.A. lacked the
resources and, in the case of cosmetics, dietary supplements and
food, the full legal authority needed to protect consumers and also
foster innovation.
Industry representatives and analysts are worried that
nanotechnology will suffer the same fate as genetic engineering,
which was quickly embraced as a breakthrough for drug makers but has
been fiercely opposed, especially in Europe, when used in crops,
fish and livestock.
Many of the same groups fighting genetic engineering in agriculture
have been arguing for regulators to clamp down on nanotechnology, in
general, and its use in food and cosmetics, in particular, until
more safety testing has been completed.
"I'm amazed at how far it's gone already," said
Ronnie Cummins,
director of the Organic Consumers [Association], an advocate for
organic products based in Finland, Minn. "Compared to
nanotechnology, I think the threat of genetic engineering is tame."
So far, there have been no confirmed reports of public health or
environmental problems related to nanotechnology. But troubling
laboratory tests suggest some nanoscale particles may pose novel
health risks by, for instance, slipping easily past barriers to the
brain that keep larger particles out. Thus, the same attributes that
could make the technology valuable for delivering drugs could also
make it hazardous.
More important, everyone agrees that there have been few rigorous
studies of the actual behavior of the newly engineered nanoscale
materials in humans and the environment. Those that have been
completed fall far short of duplicating the range of conditions the
nanoparticles would encounter in general commerce. And few
laboratory studies have focused on the fate of particles that are
eaten rather than inhaled or injected.
"Lack of evidence of harm should not be a proxy for reasonable
certainty of safety," the Consumers Union said in testimony
submitted to the F.D.A. for today's meeting. The language was
carefully chosen.
"Reasonable certainty of safety" is what food
companies must demonstrate to the F.D.A. before they can introduce a
new food additive.
The Consumers Union and some other groups are suggesting that the
agency automatically classify all new nanoscale food ingredients,
including those now classified as safe in larger sizes, as new
additives. And they want the same standards extended to cover food
supplement companies, some of which have been marketing traditional
herbal and mineral therapies in what they say are new nanoscale
forms that increase their effectiveness. Some are also calling for
mandatory labeling of products with synthetic nanoscale ingredients,
no matter how small the quantity.
F.D.A. officials said last week that treating every new
nanotechnology product that consumers swallow as a food additive
might compromise the agency's mandate to foster innovation and might
not be within its authority. Such a move would also be hobbled by
the lack of agreement on safety testing standards for the wide range
of nanoscale innovations in the pipeline. In addition, the agency
lacks the staff to handle that scale of oversight.
"That would be a sea change for us," said
Laura Tarantino, director
of the F.D.A.'s Office of Food Additive Safety.
Simply defining nanotechnology may also be a hurdle. BASF has been
widely considered a pioneer for products like its synthetic lycopene,
an additive that substitutes for the natural lycopene extracted from
tomatoes and other fruits. Lycopene, widely used as a food coloring,
is increasingly valued for its reported heart and anticancer
benefits. But BASF's particles average 200 to 400 nanometers in
diameter, about the same as the natural pigment, and well above the
100-nanometer threshold that many experts consider true
nanotechnology.
Unilever has never disclosed the dimensions of its shrunken fat
particles. Trevor Gorin, a Unilever spokesman in Britain, said in an
e-mail message that reports about the project have been misleading.
Given the uncertainty about the risks of consuming new nano
products, many analysts expect near-term investment to focus on
novel food processing and packaging technology. That is the niche
targeted by Sunny Oh, whose start-up company, OilFresh, based in
Sunnyvale, Calif., is marketing a novel device to keep frying oil
fresh. OilFresh grinds zeolite, a mineral, into tiny beads averaging
20 nanometers across and coats them with an undisclosed material.
Packed into a shelf inside the fryer, the beads interfere with
chemical processes that break down the oil or form hydrocarbon
clusters, Mr. Oh says. As a result, restaurants can use oil longer
and transfer heat to food at lower temperatures, although they still
need traditional filters to remove food waste from the oil.
Mr. Oh said OilFresh will move beyond restaurants into food
processing by the end of the month, when it delivers a 1,000-ton
version of the device to a "midsized potato chip company" that he
said did not want to be identified.
The desire to avoid controversy has made even the largest food
companies, like Kraft Foods, leery about discussing their interest
in nanotechnology. Kraft, the second-largest food processor after
Nestle, was considered the industry's nanotechnology pacesetter in
2000. That is when it announced the founding of an international
alliance of academic researchers and experts at government labs to
pursue basic research in nanotechnology sponsored by Kraft.
The Nanotek Consortium, as Kraft called the group, produced a number
of patents for the company, but Kraft pulled back from its
high-profile connection with nanotechnology two years ago. Manuel
Marquez, the research chemist Kraft appointed to organize the
consortium, moved to Philip Morris USA, a sister subsidiary of
Altria that now sponsors the consortium under a new name - the
Interdisciplinary Network of Emerging Science and Technologies.
Kraft still sends researchers to industry conferences to make what
it calls "generic" presentations about the potential uses of
nanotechnology in the food industry. But the company declines to
specify its use of or plans for the technology.
F.D.A. officials say companies like Kraft are voluntarily but
privately providing them with information about their activities.
But many independent analysts say the level of disclosure to date
falls far short of what will be needed to create public confidence.
"Most of the information is in companies and very little is
published," said Jennifer Kuzma, an associate director of the Center
for Science, Technology, and Public Policy at the University of
Minnesota, who has been tracking reports of nanotechnology use in
food and agriculture.
Back to Contents
U.S. FDA Told to Watch Nanotech Products for Risks
by Lisa Richwine
Reuters
October 11, 2006
BETHESDA, Md.
The growing number of cosmetics, drugs other
products made using nanotechnology need more attention from U.S.
regulators to make sure they are safe for humans and the planet,
consumer and environmental groups told a government hearing Tuesday.
Nanotechnology is the design and use of particles as small as
one-billionth of a meter. A human hair, by contrast, is about 80,000
nanometers across.
Materials at nano-size can have completely different properties from
larger versions, such as unusual strength or the ability to conduct
electricity.
Witnesses at a meeting called by the U.S. Food and Drug
Administration agreed nanotechnology holds promise for a vast range
of products, including new medicines to treat diseases or delivery
systems to get drugs to body parts now hard to reach.
But some complained that dozens of cosmetics and a handful of drugs
made with nanomaterials already have made it to the market while
regulators have done little to track their use or safety.
"Unfortunately, so far the U.S. government has acted as a
cheerleader, not a regulator, in addressing the nanotech revolution.
Health and environmental effects have taken a back seat," said Kathy
Jo Wetter of ETC Group, an organization that tracks the impact of
new technologies.
The FDA has treated products made with nanotechnology the same way
it handles others. For drugs with nanomaterials, that means
companies must provide evidence of safety and effectiveness before
they reach the market. But cosmetics, foods and dietary supplements
are not subject to FDA oversight before they are sold -- with or
without nanoparticles.
While no harm has been documented, concerns have arisen that the
tiny particles are unpredictable and could have unforeseen impacts
in the human body or in the environment.
As they called for close FDA oversight, many experts said they felt
the agency was ill-equipped to regulate the new technology in the
midst of other responsibilities.
"New nano-enabled drugs and medical devices ... place burdens on an
oversight agency that is already stretched extremely thin," said
David Rejeski, director of the Project on Emerging Nanotechnologies,
a group aimed at helping society anticipate and manage effects of
nanotechnology.
The FDA has created an internal task force on nanotechnology, and
officials said they called the meeting to learn what scientific
issues the agency should address.
The task force is due to report to the commissioner in nine months,
said Dr. Randall Lutter, FDA's associate commissioner for policy and
planning.
"It's not only the risks, it's also looking at the potential.
There's a lot of opportunity... to bring great things to patients,"
he said at the meeting.
Industry groups and some other experts urged the agency not to
overreact.
"The key is to manage the risk while achieving the maximum benefit
from these materials. It would be wrong for us to over-regulate,"
said Martin Philbert of the University of Michigan School of Public
Health.
Back to Contents
Engineering Food at Level of Molecules
The New York Times
October 10, 2006
At the BASF Beverage Lab in Ludwigshafen, Germany, Andreas Hasse,
left, and Clemes Sambale
assess drinks that were made with synthetic
beta-carotene, a nanoparticle used to add color and health benefits.
What if the candy maker Mars could come up with an additive to the
coating of its M&M’s and Skittles that would keep them fresher
longer and inhibit melting? Or if scientists at Unilever could
shrink the fat particles (and thereby the calories) in premium ice
cream without sacrificing its taste and feel?
These ideas are still laboratory dreams. The common thread in these
research projects and in product development at many other food
companies is nanotechnology, the name for a growing number of
techniques for manipulating matter in dimensions as small as single
molecules.
Food companies remain wary of pushing the technology — which is
named for the nanometer, or a billionth of a meter — too far and too
fast for safety-conscious consumers. But they are tantalized by
nanotechnology’s capacity to create valuable and sometimes novel
forms of everyday substances, like food ingredients and packaging
materials, simply by reducing them to sizes that once seemed
unimaginable.
Most of the hoopla and a lot of the promise for nanotechnology lies
in other industries, including electronics, energy and medicine. But
the first generation of nanotechnology-based food industry products,
including synthetic food colorings, frying oil preservatives and
packaging coated with antimicrobial agents, has quietly entered the
market.
The commercial uses of the technology now add up to a $410 million
sliver of the $3 trillion global food market, according to
Cientifica, a British market research firm that specializes in
nanotechnology coverage. Cientifica forecasts that nanotechnology’s
share will grow to $5.8 billion by 2012, as other uses for it are
developed.
Mindful of the adverse reaction from some consumers over the
introduction of genetically engineered crops, the food industry
hopes regulators will come up with supportive guidelines that will
also allay consumers’ fears. That has put a spotlight on the Food
and Drug Administration’s first public hearing today on how it
should regulate nanotechnology, with a portion of the agenda
specifically about food and food additives. No policy changes are
expected this year.
“To their credit, the F.D.A. is trying to get a handle on what’s out
there,” said Michael K. Hansen, senior scientist at Consumers Union,
one of 30 groups that have signed up to speak at the meeting.
But coping with nanotechnology will be a daunting challenge for the
agency, according to a report last week by a former senior F.D.A.
official, whose analysis was sponsored by the Pew Charitable Trusts
and the Woodrow Wilson International Center for Scholars, a
Washington policy group.
Michael R. Taylor, a former deputy
commissioner for policy at the agency, said the F.D.A. lacked the
resources and, in the case of cosmetics, dietary supplements and
food, the full legal authority needed to protect consumers and also
foster innovation.
Industry representatives and analysts are worried that
nanotechnology will suffer the same fate as genetic engineering,
which was quickly embraced as a breakthrough for drug makers but has
been fiercely opposed, especially in Europe, when used in crops,
fish and livestock.
Many of the same groups fighting genetic engineering in agriculture
have been arguing for regulators to clamp down on nanotechnology, in
general, and its use in food and cosmetics, in particular, until
more safety testing has been completed.
“I’m amazed at how far it’s gone already,” said Ronnie Cummins,
director of the Organic Consumers Group, an advocate for organic
products based in Finland, Minn. “Compared to nanotechnology, I
think the threat of genetic engineering is tame.”
So far, there have been no confirmed reports of public health or
environmental problems related to nanotechnology.
But troubling
laboratory tests suggest some nanoscale particles may pose novel
health risks by, for instance, slipping easily past barriers to the
brain that keep larger particles out. Thus, the same attributes that
could make the technology valuable for delivering drugs could also
make it hazardous.
More important, everyone agrees that there have been few rigorous
studies of the actual behavior of the newly engineered nanoscale
materials in humans and the environment. Those that have been
completed fall far short of duplicating the range of conditions the nanoparticles would encounter in general commerce. And few
laboratory studies have focused on the fate of particles that are
eaten rather than inhaled or injected.
“Lack of evidence of harm should not be a proxy for reasonable
certainty of safety,” the Consumers Union said in testimony
submitted to the F.D.A. for today’s meeting. The language was
carefully chosen.
“Reasonable certainty of safety” is what food
companies must demonstrate to the F.D.A. before they can introduce a
new food additive.
The Consumers Union and some other groups are suggesting that the
agency automatically classify all new nanoscale food ingredients,
including those now classified as safe in larger sizes, as new
additives.
And they want the same standards extended to cover food
supplement companies, some of which have been marketing traditional
herbal and mineral therapies in what they say are new nanoscale
forms that increase their effectiveness. Some are also calling for
mandatory labeling of products with synthetic nanoscale ingredients,
no matter how small the quantity.
F.D.A. officials said last week that treating every new
nanotechnology product that consumers swallow as a food additive
might compromise the agency’s mandate to foster innovation and might
not be within its authority. Such a move would also be hobbled by
the lack of agreement on safety testing standards for the wide range
of nanoscale innovations in the pipeline.
In addition, the agency
lacks the staff to handle that scale of oversight.
“That would be a sea change for us,” said
Laura Tarantino, director
of the F.D.A.’s Office of Food Additive Safety.
Simply defining nanotechnology may also be a hurdle.
BASF has been
widely considered a pioneer for products like its synthetic lycopene,
an additive that substitutes for the natural lycopene extracted from
tomatoes and other fruits. Lycopene, widely used as a food coloring,
is increasingly valued for its reported heart and anticancer
benefits. But BASF’s particles average 200 to 400 nanometers in
diameter, about the same as the natural pigment, and well above the
100-nanometer threshold that many experts consider true
nanotechnology.
Unilever has never disclosed the dimensions of its shrunken fat
particles. Trevor Gorin, a Unilever spokesman in Britain, said in an
e-mail message that reports about the project have been misleading.
Given the uncertainty about the risks of consuming new nano
products, many analysts expect near-term investment to focus on
novel food processing and packaging technology. That is the niche
targeted by Sunny Oh, whose start-up company, OilFresh, based in
Sunnyvale, Calif., is marketing a novel device to keep frying oil
fresh.
OilFresh grinds zeolite, a mineral, into tiny beads averaging
20 nanometers across and coats them with an undisclosed material.
Packed into a shelf inside the fryer, the beads interfere with
chemical processes that break down the oil or form hydrocarbon
clusters, Mr. Oh says. As a result, restaurants can use oil longer
and transfer heat to food at lower temperatures, although they still
need traditional filters to remove food waste from the oil.
Mr. Oh said OilFresh will move beyond restaurants into food
processing by the end of the month, when it delivers a 1,000-ton
version of the device to a “midsized potato chip company” that he
said did not want to be identified.
The desire to avoid controversy has made even the largest food
companies, like Kraft Foods, leery about discussing their interest
in nanotechnology. Kraft, the second-largest food processor after
Nestlé, was considered the industry’s nanotechnology pacesetter in
2000. That is when it announced the founding of an international
alliance of academic researchers and experts at government labs to
pursue basic research in nanotechnology sponsored by Kraft.
The Nanotek Consortium, as Kraft called the group, produced a number
of patents for the company, but Kraft pulled back from its
high-profile connection with nanotechnology two years ago. Manuel
Marquez, the research chemist Kraft appointed to organize the
consortium, moved to Philip Morris USA, a sister subsidiary of
Altria that now sponsors the consortium under a new name — the
Interdisciplinary Network of Emerging Science and Technologies.
Kraft still sends researchers to industry conferences to make what
it calls “generic” presentations about the potential uses of
nanotechnology in the food industry. But the company declines to
specify its use of or plans for the technology.
F.D.A. officials say companies like Kraft are voluntarily but
privately providing them with information about their activities.
But many independent analysts say the level of disclosure to date
falls far short of what will be needed to create public confidence.
“Most of the information is in companies and very little is
published,” said Jennifer Kuzma, an associate director of the Center
for Science, Technology, and Public Policy at the University of
Minnesota, who has been tracking reports of nanotechnology use in
food and agriculture.
Back to Contents
Open Letter to the FDA to Stop Corporations
...from Lacing Foods, Body
Care Products, & Supplements with Dangerous Nanoparticles
by Ronnie Cummins
National Director
Organic Consumers Association
Sept 23, 2006
Acting FDA Commissioner Andrew C. Von Eschenbach
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Commissioner Von Eschenbach,
I write to express my serious concerns about the FDA's regulatory
oversight of nanomaterials in consumer products. Many consumer
products containing engineered nanomaterials are already available
on U.S. market shelves, including food and food packaging products.
Millions of dollars are being spent by government and industry to
apply nanotechnology in areas of food processing, food packaging,
and agricultural production. Current nano-food products on the
market include a canola oil, a chocolate "slim" shake, a nano-bread,
and several nano-food additives and supplements used in soft drinks,
lemonades, fruit juices, and margarines. Many food packaging
products use nano-composites, nano-clays, and nano-coatings.
In
addition, if industry observers are correct, hundreds of more new
food and agriculture products are under development and many could
be on the market in as few as two years. By 2010 the nano-food
market will be $20 billion. Many of the world's leading food
companies - including H.J. Heinz, Nestle, Hershey, Unilever, and
Kraft - are investing heavily in nanotechnology applications.
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 create new risks, like enhanced
toxicity. Studies have raised numerous red flags, and many types of
nanoparticles have proven to be toxic to human tissue and cells.
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. The FDA's failure to undertake or review new
testing of these nanomaterials despite these known and foreseeable
dangers suggests the agency's review process is not acting to ensure
consumer health and safety.
For these reasons, I strongly request that FDA use its upcoming
Public Meeting and its new Nanotechnology Task Force to discuss the
human health and environmental risks presented by nanomaterials in
consumer products, including food and food packaging products. FDA
should act quickly to shore up its regulation of these substances to
account for their fundamentally different properties and their
associated dangers, including require new nano-specific testing and
the labeling of all nanomaterial products, including nano-food
products.
Currently, FDA's reliance on manufacturers' assurances of safety
make me and my family into guinea pigs. FDA must instead
independently review all testing and assess the safety of these
products as well as force manufacturers to label their nanomaterial
products. 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.
Ronnie Cummins
National Director
Organic Consumers Association
Finland, Minnesota 55603
Back to Contents
FDA not 'nano-ready', says report
by Clarisse Douaud
10/5/2006
A former FDA deputy commissioner for policy has
denounced the agency's capacity to properly regulate nanotechnology
products including supplements, a criticism that could inflame
debate leading up to the agency's first major public meeting on the
atomic technology.
In a report commissioned by the Woodrow Wilson Center's project on
emerging nanotechnologies, University of Maryland School of Medicine
professor Michael Taylor concluded the US Food & Drug
Administration's resource base is severely eroded. This is despite
what appears to be a recent nanotechnology policy kick-start at the
FDA.
The report reveals regulatory weaknesses affecting new products,
such as certain dietary supplements and cosmetics, using the
technology. Critics say questions over nanotechnology safety have
not been answered and the FDA is not in a position to effectively
police it.
"Unless the FDA addresses potential nanotechnology risks now, public
confidence in a host of valuable nanotechnology-based products could
be undermined," wrote Taylor, who was deputy commissioner for policy
at the Food and Drug Administration from 1991 to 1994 and currently
conducts research on policy, resource, and institutional issues
affecting public health agencies.
Nanotechnology is the ability to control things at an atomic and
molecular scale of between one and 100 nanometers and has been met
with enthusiasm across a variety of industries. Critics highlight
the murky area of how nanoparticles affect toxicity and say the
particles should be treated as new, potentially harmful materials
and tested for safety accordingly.
"There are important gaps in FDA's legal authority that hamper its
ability to understand and manage nanotechnology's potential risks,"
wrote Taylor. "This is particularly true in the area of cosmetics
and dietary supplements, and in the oversight of products after they
reach the marketplace."
Unlike pharmaceuticals, which must go through a series of pre-market
approvals, finished dietary supplements need no pre-market approval.
Under the Dietary Supplement Health and Education Act (DSHEA), which
is part of the Food and Cosmetics Act, only ingredients not marketed
in the US before October 1994 must be approved by FDA before use in
consumer products.
Thus, as it stands, pre-market regulation of nanotechnology in
dietary supplements does not fall under FDA's regulatory umbrella,
nor - according to Taylor - can it fit into the agency's budget.
But Taylor points out in the report that the FDA is restricted in
what it can do due to a dire lack of funding under the current
administration. In order to continue activities mandated in 1996,
FDA's 2006 budget would have to increase by 49 percent, according to
Taylor, and under President Bush's 2007 FDA budget this funding gap
will grow to 56 percent.
"But FDA's lack of 'nano-readiness' is about more than dollars,"
said Taylor.
"Business and health leaders alike should join in ensuring that FDA
has the scientific tools and knowledge it needs to say 'yes' to safe
and effective new products," said Taylor.
The market stands to benefit from nanotechnology and therefore also
stands to lose a lot, according to Taylor, if it is not thoroughly
regulated.
In 2005, nanotechnology was incorporated into more than $30bn in
manufactured goods, according to Lux Research, almost double the
previous year. The market analyst projects that by 2014, 15 percent
of all global manufactured goods will incorporate nanotechnology.
The Washington, DC-based Woodrow Wilson International Center for
Scholars initiated its project on emerging nanotechnologies in 2005
with the aim of helping business, government and the public manage
possible implications of the technology.
FDA's nanotechnology public meeting will take place October 10, 2006
in Bethesda, Maryland.
According to FDA, the purpose of the meeting is to help the agency
in its understanding of developments in nanotechnology materials
relating to FDA-regulated products.
"FDA is interested in learning about the kinds of new nanotechnology
material products under development in the areas of foods (including
dietary supplements), food and color additives, animal feeds,
cosmetics, drugs and biologics, and medical devices…" states an
online FDA notice for the upcoming meeting.
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Nanotechnology Risks Unknown
Insufficient Attention Paid to Potential Dangers, Report Says
by Rick Weiss
Washington Post Staff Writer
Tuesday, September 26, 2006; Page A12
The United States is the world leader in nanotechnology -- the newly
blossoming science of making incredibly small materials and devices
-- but is not paying enough attention to the environmental, health
and safety risks posed by nanoscale products, says a report released
yesterday by the independent National Research Council.
If federal officials, business leaders and others do not devise a
plan to fill the gaps in their knowledge of nanotech safety, the
report warns, the field's great promise could evaporate in a cloud
of public mistrust.
"There is some evidence that engineered nanoparticles can have
adverse effects on the health of laboratory animals," the
congressionally mandated report said, echoing concerns raised by
others at a House hearing last week. Until the risks are better
understood, "it is prudent to employ some precautionary measures to
protect the health and safety of workers, the public, and the
environment."
The 176-page report, "A Matter of Size," was prepared under the
auspices of the National Academies, chartered to advise Congress on
matters of science. It focuses on the National Nanotechnology
Initiative, which coordinates and prioritizes federal research in
nanotechnology -- the fledgling but potentially revolutionary
science that deals with materials as small as a billionth of a
meter.
At that size, even conventional substances behave in unconventional
ways. Some materials that do not conduct electricity or are fragile,
for example, are excellent conductors and are extremely strong when
made small enough. But nanoparticles can also enter human cells and
trigger chemical reactions in soil, interfering with biological and
ecological processes.
The report concludes that the U.S. research effort is vibrant and
almost certainly the strongest in the world, though a few other
countries are close behind. Among the more important unmet needs, it
says, is stronger collaboration with the departments of Education
and Labor to boost the supply of scientists and technicians with the
skills the sector needs.
The report's concerns about the lack of a federal focus on nanotech
health and safety were foreshadowed at a House Science Committee
hearing Thursday at which Republicans and Democrats alike took the
Bush administration to task over the lack of a plan to learn more
about nanotech's risks.
Committee Chairman Sherwood L. Boehlert (R-N.Y.) accused the
administration of "sauntering" toward solutions "at a time when a
sense of urgency is required."
Ranking Democrat Bart Gordon (Tenn.) went further, calling the
administration's latest summary of nanotech research needs, released
at the hearing, "a very juvenile piece of work."
Andrew Maynard, chief science adviser for the Project on Emerging
Nanotechnologies, funded in part by the Smithsonian Institution,
said the government is spending about $11 million a year on
nanotechnology's potential harms when industry and environmental
groups have jointly called for at least $50 million to $100 million
a year.
Equally important, Maynard said, is the need for a coordinated
strategy to spend that money wisely.
About 300 consumer products already contain nanoscale ingredients,
Maynard said, including several foods and many cosmetics, with
little or no research to document their safety.
The industry is expected to be worth about $2 trillion by 2014.
Norris Alderson, associate commissioner for science at the Food and
Drug Administration and chairman of the working group that created
the administration's summary research plan presented to Congress
last week, said the document -- which was supposed to be delivered
six months ago -- was meant as "a first step."
Asked by Boehlert if he understood that much more is expected of him
and his working group, Alderson responded:
"I think your message is
loud and clear."
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