New research published in the journal Nanotoxicology, suggests that gold nanoparticles found in a number of current products (personal care products, drug delivery, MRI contrast agents, solar cells) can affect adult stem cell functions, with potential impacts including inhibited fat storage, accelerated aging and wrinkling, slowed wound healing, and the onset of diabetes.  The work is “Gold nanoparticles cellular toxicity and recovery: Adipose Derived Stromal cells.”

The research team was led by Tatsiana Mironava, a visiting assistant professor in the Department of Chemical and Molecular Engineering at Stony Brook University. They tested the impact of nanoparticles in vitro on multiple types of cells, including adipose (fat) tissue, to determine whether their basic functions were disrupted when exposed to very low doses of nanoparticles. Subcutaneous adipose tissue acts as insulation from heat and cold, functions as a reserve of nutrients, and is found around internal organs for padding, in yellow bone marrow and in breast tissue.

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A consortium of scientists has found that breathing ultrafine particles from a large family of engineered nanomaterials (ENMs) that increasingly are found in a host of household and commercial products can cause lung inflammation and damage. The researchers examined responses of the lungs to nanomaterials made from three forms of titanium dioxide and three forms of multi-walled carbon nanotubes in a mouse model. The primary concern for exposure to most ENMs is by inhalation, although dermal, eye and ingestion exposures also may occur during the manufacture and commercial application of these materials in a wide variety of products.

The research on two of the most common types of ENMs already in widespread use was published online May 6, 2013, in Environmental Health Perspectives, the journal of the National Institute of Environmental Health Sciences (NIEHS). It is the first multi-institutional study examining the health effects of engineering nanomaterials to replicate and compare findings from different labs across the country.

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Another "good news, bad news" post about nanosilver. Nanosilver is increasingly used in consumer goods, as well as medical and environmental applications, on account of its effective antimicrobial properties against certain pathogens. But a new study conducted by researchers at the University of New South Wales (UNSW), Australia, shows that overexposure to silver nanoparticles could cause other potentially harmful organisms to rapidly adapt and flourish.

The new research cautions that more work is needed to understand how micro-organisms respond to the disinfecting properties of silver nano-particles.

This result, published in the journal Small, could have wide-reaching implications for the future use of nanosilver as an antimicrobial agent with biomedical and environmental applications.  “We found an important natural ability of a widely occurring bacteria to adapt quite rapidly to the antimicrobial action of nanosilver. This is the first unambiguous evidence of this induced adaptation,” says co-author Dr Cindy Gunawan, from the UNSW School of Chemical Engineering.

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Research by scientists at the University of Bath (UK) is challenging claims that nanoparticles in medicated and cosmetic creams are able to transport and deliver active ingredients deep inside the skin.

The Bath study, published in the August 20, 2012, issue of the Journal of Controlled Release, found that even the smallest of nanoparticles tested did not penetrate the skin’s surface.

These findings have implications for pharmaceutical researchers and cosmetic companies that design skin creams with nanoparticles that are supposed to transport ingredients to the deeper layers of the skin.  The efficacy of those products may have to be reconsidered. 

From a safety and risk standpoint the findings are significant because they allay concerns that potentially harmful nanoparticles such as those used in sunscreens (e.g. titanium dioxide) can actually be absorbed into the body through dermal exposure.

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The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.

"[Draft] Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives," covers the use of nanotechnology in the manufacture of food ingredients, including color additives, and food contact substances, e.g., packaging.

“[Draft] Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” covers the use of nanotechnology in cosmetics.

These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012, "Tightening FDA Nanotech Regs on Food, Cosmetics."

According to Tyler: "The message of the two guidance documents is similar: Manufacturers in these industries who incorporate nanoscale ingredients into their products should be prepared to prove that the resulting products are safe and that appropriate tests were used to validate their safety."

Excerpts of the article are provided below.

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The first lawsuit over regulation of the health and environmental risks of nanotechnology and nanomaterials has been voluntariliy dismissed.  That suit was the subject of my post, First Lawsuit on Risks of Nanotechnology in Consumer Products is Filed.

The Lawsuit's Origin

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The Lawsuit's Conclusion

The Plaintiff groups agreed to drop the lawsuit because the FDA has now formally responded to their petition, though the agency rejected some of their key proposals.  The groups had also requested that the agency subject its nanotechnology program to a comprehensive environmental review under the National Environmental Policy Act.

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According to a recent article in the firefighting community publication "Firehouse," the proliferation of nanomaterials in consumer products is making the microscopic materials that become airborne during fires even more deadly than realized

Firefighters and responders have known for decades the dangers of smoke to their health, but the increasing use of nanotechnology in products that burn is adding a different dimension to the danger. 

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A new study published in the February 21, 2012, issue of American Chemical Society journal Environmental Science & Technology ("Titanium Dioxide Nanoparticles in Food and Personal Care Products"), provides the first broadly based information on amounts of the nanomaterial – a source of concern with regard to its potential health and environmental effects – in a wide range of consumer goods.

The study attempts to quantify the amount of nanoparticle TiO2 in common food products, derive estimates of human exposure to dietary nano-TiO2, and discuss the impact of the nanoscale TiO2 entering the environment.

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The Natural Resources Defense Council (NRDC) filed a federal suit against the U.S. Environmental Protection Agency on January 26, 2012, seeking to overturn EPA's decision to conditionally approve nanosilver under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It marks the first time ever that EPA's approval of a nanoscale chemical has been challenged in court. The NRDC petition was filed with the 9th U.S. Circuit Court of Appeals, headquartered in San Francisco, Calif.

The NRDC petition claims that sales of the nanosilver-based pesticide should be halted because the health risks of the substance are unknown. The environmental advocacy group, which has been highlighting potential safety concerns about the use of ultra-tiny silver particles as an antimicrobial agent for several years, accused the EPA of giving the manufacturer a “four-year free pass” by allowing the pesticide to come to market before health and safety testing has been completed.

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In a new report, “The Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials”, by the United States-based non-profit organization, As You Sow, sxperts in environmental health issues teamed with major companies to advise food industries to exercise caution when using nano-sized, manmade creations as nutritional additives, flavorings, colorings, or anti-bacterial coatings for packaging.

As You Sow teamed up with several major food companies, including Kraft, McDonald’s, Whole Foods, Yum! Brands, and Pepsi, to create the Framework. According to the study, as "food and food packaging companies explore the use of nanomaterials to enhance products, they need also attend to potential risks introduced."

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The legal battle has finally been joined.  The first lawsuit over the health and environmental risks of nanotechnology and nanomaterials has been filed.

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The eighty-page 2006 Petition documents the groups' claimed scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency. The FDA had yet to act on the 2006 petition, prompting the suit.

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You may be interested in an article published by BNA's Product Safety & Liability Reporter in November 2011: "Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It"

The article is a very good collaboration by attorneys William Rogers and Joseph Clark (Day Pitney LLP) and scientists Joyce Tsuji, David Dahlstrom, and Steven Arndt (Exponent), and provides guidance about how to approach the new world of labeling, warning, and instruction creation for products containing nanomaterials.

A few excerpts are provided below, to help you decide whether you want to get the full article.

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A new study led by a group of Nanyang Technological University (NTU) researchers suggests that one of the most commonly used nanomaterials for consumer products can potentially cause cancer.

The chemical, Zinc Oxide (ZO), is used to absorb harmful ultra violet light. But when it is turned into nano-sized particles, they are able to enter human cells and may damage DNA, according to the new research findings. This in turn activates a protein called p53, whose duty is to prevent damaged cells from multiplying and becoming cancerous. However, cells that lack p53 or do not produce enough functional p53 may instead develop into cancerous cells when they come into contact with ZO nanoparticles.

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The U.S. Environmental Protection Agency announced on June 9, 2011, that it plans to obtain information on nanoscale materials in pesticide products.

Pesticidal Applications of Nanotechnology:  The use of nanoscale materials in pesticide products and treated articles may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of spray-applied surface disinfection. These could contribute to improved human and environmental safety and could lower pest control costs. For example, as a materials preservative, nanosilver should maintain its ability to reduce the number of odor causing bacteria longer and require smaller quantities than other silver preservatives due to an expected gradual and controlled release of silver ions from nanosilver as opposed to the rapid release of for example, silver ions from a zeolite structure or the immediate dissolution of a silver salt. 

Regulation of Nanotechnology in Pesticides:  FIFRA and EPA’s implementing regulations provide an effective framework for regulating pesticide products that contain a nanoscale material. Currently, the Office of Pesticide Programs (OPP) describes a nanoscale material as an active or inert ingredient of a pesticide and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

The OPP recognizes that special properties that make nanoscale materials of potentially great benefit also can present new challenges for risk assessment and decision-making.  For instance, their small size may allow them to pass through cell membranes or the blood-brain barrier, possibly resulting in unintended effects.  The EPA recognizes that government, academic, and private sector scientists in multiple countries are performing research into the human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence.

New Policy for Nanotechnology in Pesticides:

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It has long been understood that environmental conditions may influence plant ion concentrations in crop plants. Under specific growing environments, plants absorb essential and nonessential elements, which above certain concentrations may cause toxicity. In addition, toxic elements with no known function in biological systems are found to be accumulated in plant tissues, with potentially lethal effects for nontolerant species (for example, livestock or humans). Once stored within plants, beneficial or toxic elements can be transferred from producers (plants) to consumers.

A recent article in the Journal of Agricultural and Food Chemistry notes that the uptake, bioaccumulation, biotransformation, and risks of nanomaterials (NMs) for food crops are still not well understood.  "Interaction of Nanoparticles with Edible Plants and Their Possible Implications in the Food Chain," prepared by researchers at the University of Texas at El Paso, concerns a review of nearly 100 scientific articles on the effects of different types of nanoparticles on edible plants.

According to the article, the curtain is about to rise on a “much-anticipated new era of ‘nanoagriculture’ – using nanotechnology to boost the productivity of plants for food, fuel and other uses.” There remains, however, a huge gap in knowledge about the effects of nanoparticles on corn, tomatoes, rice and other food crops. Some plants can take-up and accumulate nanoparticles, but it is unclear if this process hurts the plants, or the animals that eat them. The researchers found the uptake and build-up of nanoparticles varies, with the factors depending largely on the type of plant and the size and chemical composition of the nanoparticles.

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed  in response to a request from the European Commission,

 

“Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” is the work of the EFSA’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives and pesticides.

 

The EFSA guidance sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties.

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Nanodermatology Society  

Where NANOTECHNOLOGY and DERMATOLOGY Meet

A number of posts in the past year have concerned updates about the potential risks of nanoparticles that are now in common use in sunscreen products – namely Zinc Oxide (ZnO) and Titanium Dioxide (TiO2). Some groups, such as Friends of the Earth, claim that nano-based sunscreens are actually hazardous to human health.

To address concerns, the Nanodermatology Society (NDS) was formed in 2010.
The NDS is a non-profit organization charged with monitoring nanotechnology as it relates to the diagnosis, prevention, and treatment of skin disease and evaluating their potential benefits and risks. The Society is composed of physicians, dermatologists, physicists, chemists, policy makers, regulators, nanotechnology scientists, and students involved in nanotechnology specifically related to dermatology from teaching, to education, to scientific research. For more information, see the NDS web site at www.nanodermsociety.org.

NDS has conducted what it considers a rigorous review of the scientific literature regarding the use and safety of nano-sized ultraviolet blocking ingredients. The result is issuance of The 2011 Nanodermatology Society Position Statement on Sunscreens.

"The picture is clear from all the available data," explains Dr. Adam Friedman Vice-President of the Nanodermatology Society and senior author of the Position Statement. "To date, the data show that the nanotechnology used in sunscreens is safe."

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The American Society for Nanomedicine wrapped up its second annual conference in October 2010 with a presentation by two toxicology experts.  The meeting focused on mind-blowing nanomedicine research, but was tempered by a sobering message: "a new frontier comes with new, and often unknown, risks."

Gunter Oberdorster, a professor of environmental medicine at the University of Rochester, and Paul Howard, an official with the Food and Drug Administration's National Center for Toxicology Research, each said there are reasons to be concerned about the human and environmental impact of nanomedicine, particularly since there is a simple lack of knowledge about exactly what these new materials do.

According to Oberdorster, who is well-known and highly regarded in the nanotoxicology field, the common thinking about all nanomaterials is that they’re small and move freely around the body, and that humans have few defenses against them. Oberdorster suggested that it now seems clear that some nanoparticles, such as carbon nanotubes, can do harm to the body. But it is still unknown how other engineered nanosubstances, especially those being used in medical applications, will fare.

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Zinc, one of the most abundant metals in biological systems, is essential to life.  Zinc plays an important role in the brain; pancreas; intestine; and in the salivary, pituitary, and prostate glands.  Excess zinc, however, is toxic and can suppress absorption of other life-critical metals.  The question is, what are the likely health impacts of zinc oxide nanoparticles?  

Zinc oxide (ZnO) nanoparticles are already commonly used in personal-care product formulations (sunscreens and cosmetics) as a protective agent against UV radiation.  A number of groups have raised questions whether zinc oxide nanoparticles are safe.  For example, in my post, Are Nanoparticles in Sunscreens Safe?  Friends of the Earth says "Nano should be a no-no," I point out that FoE claims that scientific research already completed indicates that metal oxide nanomaterials used in sunscreens (such as zinc oxide) can:

• Damage human colon cells.
• Damage brain stem cells in mice.
• Penetrate healthy adult skin.
• Travel up the food chain from smaller to larger organisms.
• Damage important microbes in the environment.
• Travel from mothers to unborn fetuses.

The existing research does not, in my view, support the FoE's strong and unqualified conclusions that nanoparticles like ZnO are dangerous to humans when used in topically applied suncreens and cosmetics.  

Meanwhile, new research in the past few months sheds additional light but also raises questions for further study.

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An October 25, 2010, joint press release from Europe’s two largest consumers umbrella groups, BEUC and ANEC, is entitled “ANEC/BEUC inventory exposes a game of roulette.”

"Nano whitening"

"Using the newest Nanotechnological ingredients"

"Uses the Nano Silver technology which protects the baby's skin"

Consumer products containing a number of nanomaterials are already widely available on the European market and these are just some of the come-ons used in stores or online.

In 2009 the European Consumers' Organization (BEUC) and its sister organization, ANEC, started to monitor the availability of consumer products containing nanomaterials. The initial 2009 inventory listed 151 products, while in 2010 the number rose to 475. The BEUC inventory has product categories representing those most often consumed in everyday life such as child products, food & drink, cosmetics, products for cars and electronic devices.

The inventory and explanatory leaflet can be found on the BEUC website.

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This is the second in a two-part blog article that discusses nanotechnologies in the vehicle manufacturing business. In Part 1 I identified many of the current and near-future applications of nanomaterials in vehicle manufacturing and the big rewards that can be expected in performance, cost, and safety.  

In this post I outline the environmental, health, and safety risks that loom large as nanotechnologies are rolled out in the vehicle segment.

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Nanotechnology is already quietly being used in vehicle manufacturing but engineered nanomaterials are about to hit the automobile world full-force, and with dramatic impact. They allow plastics, textiles, alloys and coatings to have new and highly advantageous and marketable properties. They allow for improvements in electronics that were unthinkable just 10 years ago.  And the results could be both good and bad.

This two-part blog article discusses both the tremendous opportunities and the potentially huge risks that are coming with the integration of numerous nanomaterials into the automotive sector.   First, the big rewards. 

Current Automotive Nanotechnology Applications 

This short video describes just a few of the many current and near-future uses of nanoparticles in vehicle manufacturing.  http://www.youtube.com/watch?v=p2l-pr--qCU

The list of specific automotive nanotechnology applications includes at least the following: 

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ASTM International Committee E56 on Nanotechnology has created a new subcommittee, E56.06 Nano-Enabled Consumer Products.

The scope of E56.06 is to develop scientifically credible standards for identification, evaluation and assessment of engineered nanomaterials in consumer products.

Members of E56.06 will develop standards for determining the presence of engineered nanomaterials in consumer products and understanding the potential for exposure from the use of ENM in consumer products.

Early focus on nanosilver:  Initial subcommittee projects under consideration include several focused on the increasingly widespread use of nanosilver (as an antimicrobial) in a wide array of consumer products:

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The European Food Safety Authority (EFSA) and Belgian Federal Agency for the Safety of the Food Chain are hosting an International Symposium on Nanotechnology in the Food Chain, to be held in Brussels, Belgium on November 24, 2010.

Nanotechnology has many promising applications emerging for the areas of agriculture and food (smart packaging, agrochemicals, etc.). It has the potential to bring significant benefits to the agriculture and food industries and to consumers, but may also introduce potential risks for human health and the environment.

The Symposium will present the current knowledge regarding the applications, opportunities and risks of nanotechnology in the food chain.  It will also consider the gaps in knowledge, legislation and control methods, in order to inform an international audience of policy makers, consumers, researchers, industrial representatives, etc.

Complete information on the Symposium and the program may be found on this site:
http://www.favv-afsca.fgov.be/nanotechnology/information/

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Ahead of the EU Commission’s nanotechnology regulatory review next year, several EU members are advocating the creation of a specific register for nanomaterials under the EU’s REACH (Registration, Evaluation, and Authorization of Chemicals) chemicals regulation. There are also calls for mandatory labeling of the presence of nanomaterials in consumer products sold in the EU.

Most recently, on September 14, 2010, the Belgian EU Presidency proposed those nanotechnology regulatory measures at the opening of an EU workshop on the traceability of nanomaterials. "Nanomaterials are increasingly present in consumer products and everyday items we use, and yet we don't know a lot about them," said Paul Magnette, the Belgian minister in charge of consumer protection and environment. He also argued that "the current development approach for nanomaterials without prior notification of their presence or labelling of their characteristics or potential toxicity is not acceptable".

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Environmental group Friends of the Earth (FoE) this week launched a summer advertising and public education campaign asserting that sunscreens containing manufactured nanoparticles could threaten human and environmental health.  See the link below:
http://foe.org/public-warned-about-nanosunscreen-risks

“What many beachgoers and others enjoying the summer sun don’t know is that the sunscreens they’re using contain manufactured nanoparticles that pose health risks,” said Friends of the Earth’s health and environment campaigner, Ian Illuminato. “What more and more studies are showing is that manufactured nanoparticles may be able to damage cells and have harmful health repurcussions. They also pose risks to workers and the environment, and there’s no evidence that they make sunscreens more effective at blocking the sun’s harmful rays.”

Friends of the Earth has placed an overview of what it says is the latest research related to nanosunscreens and human health at http://foe.org/healthy-people/nanosunscreens, and is advertising the web page via ads on several websites.

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Nanotechnology can enhance the flavor and other sensory characteristics of foods, introduce antibacterial nanostructures into food packaging, and encapsulate and deliver nutrients directly into targeted tissues, among other applications. However, as with any new technology, along with the benefits, there is the potential for unanticipated adverse effects.

There is still a great deal to learn about any health outcomes related to introducing nanosized materials into foods and food packaging materials. Developing nanotechnology into a safe, effective tool for use in food science and technology will require addressing these and other questions.

There is a robust debate about the appropriate use of nanotechnologies in the food/agriculture industry when open questions remain about consumer safety, as I observed in Part I of this series of posts on June 3, 2010.

I suggest two additional sources of information for folks interested in the nanotechnology food safety issue:

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“Nanotoxicology 2010” will be held from June 2nd – June 4th 2010, at Edinburgh Napier University, Edinburgh, Scotland.

Speakers presenting at Nanotoxicology 2010 are an esteemed international group of highly respected nanotechnology experts from industry, government, and academia in the United States, Canada, Europe, and Asia.

The conference will take place over 3 days, and will be divided into sections that allow focus on specific types of nanomaterials including carbon nanotubes (the most commonly used nanomaterial in industrial applications), nanometals (such as nanosilver, increasingly common in consumer products), and nanometal oxides (such as nano-titanium dioxide and nano-zinc oxide, the nanomaterials most widely used in consumer products currently).

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Citing both Canadian and U.S. sources, a recent YouTube-hosted video with the above title was recently posted at the Nanotechnology.org website.

The brief audio/video report (1:17 in length) runs through a number of general media headlines in the past year — such as “U.S. nanotechnology safeguards inadequate” and “Health Canada yet to respond to expert calls for better nanotechnology regulations” — pointing out that “critics warn that not nearly enough is known about how these altered materials might affect the human body and the environment.”

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Responding to a recent series of AOL News articles questioning the oversight of nanotechnology product safety, nanoTox™, Inc. COO Greg King said that nano-product companies will need to confront possible negative perceptions directly to avoid the kinds of public outcry experienced by bioengineered food companies in the past.

“It’s in people’s nature to fear the unknown,” said King. “And while companies may not be able to educate everyone in the complexities of nanotechnology, they can turn safety concerns to their advantage by being transparent about its use in their products, documenting their careful research and emphasizing concern over human and environment health.”

King was responding to the recent AOL News Special Report series entitled “The Nanotech Gamble” which explored possible risks that may accompany nanotechnology research and product development.   The series was greeted with concern by most in the U.S. nanoproduct industry.  See my May 12, 2010 post for more about the series. 
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“A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.”

Strong words.  They are the opening sentence in Part 1 of a recent Special Report series of articles by Andrew Schneider, an investigative reporter, two-time Pulitzer winner, and Senior Public Health Correspondent for AOL News.  In his series, "The Nanotech Gamble: Bold Science, Big Money, Growing Risks,” which ran in AOL News beginning March 24, 2010, Schneider is harshly critical of federal government’s nanotech safety research efforts so far, asserting that federal funding actually “skimps on safety.”

The AOL Special Report series is a "must read" for anyone keeping abreast of the ongoing debate and discussion of nanotechnology safety. 

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Because nanoscale sunscreen and cosmetics ingredients currently are in relatively widespread consumer use – both zinc oxide and titanium dioxide – there has been an early focus on the health and safety of those specific nanoparticles. I have written about that research in several posts in the past few months (March 3, February 18). That research focused on whether dermal absorption of either TiO2 or ZnO resulted in the nanoparticles entering the bloodstream. It looks like that can happen. But what happens then?
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Just one week after publication of a study (see my Feb 18 post) by scientists at FDA and National Cancer Institute suggesting that one of the common nanoscale sunscreen ingredients – Titanium Dioxide (TtiO2) – is unlikely to penetrate healthy human skin and enter the bloodstream, research presented last week at the International Conference on Nanoscience and Nanotechnology in Sydney, Australia, shows that the skin can absorb and retain zinc oxide (ZO) nanoparticles, which are another nanoscale ingredient found commonly in many sunscreens and some makeup.
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Scientists from the FDA and the National Cancer Institute have found that nanoscale titanium dioxide used in sunscreen is unlikely to penetrate healthy human skin. The study, "Lack of Significant Dermal Penetration of Titanium Dioxide (TiO2) from Sunscreen Formulations Containing Nano- and Sub-micron-sized TiO2 Particles," published February 15, 2010, in Toxicological Sciences, addresses concerns that the commonly used sunscreen nanoscale ingredient could cause harm to people if capable of entering the bloodstream through dermal absorption. read more

Could Nanoparticles Cause "Dramatic Mutations?"

A 12/13/09 web-based article on Discovery Communications' treehugger.com site poses the above question with the accompanying image.  The overly dramatic choice of words notwithstanding, the substance of the article is another interesting discussion of the on-going debate and emerging science about the safety of nanosilver particles, which are finding their way into more and more consumer products every month.  

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Research funded by the National Institutes of Health, and published in the journal Cancer Research in November 2009, shows that titanium dioxide (TiO2) nanoparticles cause systemic genetic damage in mice. The research, completed at UCLA's Jonsson Comprehensive Cancer Center, is the first to show that the widely-used nanoparticles had such an effect, said Robert Schiestl, the study's senior author and a Professor of pathology, radiation oncology and environmental health sciences. read more

Two European consumer organizations – the European Consumers' Organisation (BEUC) and the European Consumer Voice in Standardisation (ANEC) – have jointly launched an on-line nanotechnology inventory intended to inform the public of products offered in the EU market that contain nanomaterials.  Both the ANEC and the BEUC are concerned that products containing nanomaterials are being offered for sale in the EU market without having been subject to a proper safety assessment. read more

On October 26, 2009, The Advisory Committee on Hazardous Substances to the United Kingdom's Department of Environment, Food and Rural Affairs (Defra), issued a "Report on Nanosilver.”  The Report warns that more information on both the hazards of and exposure to nanosilver is urgently required, and recommended to British agencies that they gather information about products containing nanosilver. read more

An October 21, 2009, paper by Germany's Federal Environment Agency (Umweltbundesamt, UBA) triggered fearful headlines in some of the country's biggest newspapers and in the blogosphere:

"German Environment Agency: Don’t use nano-materials!”

“Nanotechnology can make you sick”

“The German Environment Agency warns against nanotechnology”

The paper, "Nanotechnology for Humans and the Environment: Increasing Chances, Minimizing Risks," certainly expresses reservations about nanotechnology. For example, the UBA calls for a register of nanotechnology products and consumer product labeling indicating that a product contains nano-particles. But the paper is cautious in its criticism and certainly not anything close to the near hysteria expressed by some respectable German newspapers and others that have picked up those stories.

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An article by Reed D. Rubinstein of Greenberg Traurig LLP, in the new issue of Nanotechnology Law & Business (Fall 2009), discusses a “petition” filed with the United States Environmental Protection Agency (EPA) by the International Center for Technology Assessment (ICTA) and other special interest groups. The Petition claims that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” As a result, the Petition demands (among other things) that the EPA regulate all nano-silver products as pesticides, and stop the use or sale of all consumer products using nano-silver under the authority of FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act. read more

Regulation and Standards Development is Active . . .

- Government
- Quasi-Government
- Industry/Private Sector

. . . but still in early stages. No current health or environmental regulatory program squarely addresses nanotechnology or its applications.   EPA, FDA, OSHA, CPSC and USDA all claim statutes and regulations that could pertain to nanomaterials, as do federal research agencies such as CDC-NIOSH, NIH, and NIEHS (all agencies of the Dept. of HHS).  Each is currently evaluating to address novel risks of nanotechnologies and nanoparticlesgermane to their respective regulatory missions, and several now have stand-alone nanotechnology-focused working groups and have published initial reports of interest.  For example:

Environmental Protection Agency (EPA)

-   EPA, Nanotechnology White Paper (2007) http://epa.gov/ncer/nano/publications/whitepaper12022005.pdf 

For current information see the EPA's nanotechnology web page.

Food and Drug Administration (FDA)

 -  FDA, Nanotechnology Task Force Report (2007)http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

For current information see the FDA's nanotechnology web page.

Centers for Disease Control and Prevention / National Institute for Occupation al Safety and Health (CDC-NIOSH)

-  CDC-NIOSH, Progress Toward Safe Nanotechnology in the Workplace (2007) http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf

For current information see the CDC-NIOSH nanotechnology web page.

Consumer Product Safety Commission (CPSC)

    Although the CPSC has no similar agency-level nanotechnology report, a good discussion of relevant consumer product nanotechnology issues was published by the Project on Emerging Nanotechnologies:

-  The CPSC and Nanotechnology (2008)
http://www.nanotechproject.org/process/assets/files/7033/pen14.pdf

 The CPSC recognizes that nanotechnology will be a continuously increasing concern, and nanotechnology was a focal point of the CPSC's August 25, 2009, hearing on its 2010-2011 agenda, priorities, and strategic plan.  Panelists at the hearing urged the CPSC to increase oversight of products manufactured with nanomaterials and to establish relevant safety guidelines for their use.    To read the panelists full testimony, see the CPSC web page.

 

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The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.

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