Nanotortlaw Blog

Do Burning Nanomaterials Spell Danger For Firefighters?

Sat, 28 Apr 2012 12:53:53 GMT

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.

Capt. Peter McBride Ottawa (Canada) Fire Services spoke of the dangers of nanotechnologies, which can contain some toxic materials, at a recent Fire Department Instructors Conference (FDIC) in Indianapolis. He is a safety officer responsible for the health and safety of the firefighters in his department. McBride says he became acutely interested in nanotechnologies when a huge downtown sporting goods store burned and belched acrid black smoke for blocks. Carbon fiber sporting goods, including thousands of skis, burned and emitted microscopic particles that coated everything, particularly his white department-issued SUV. He noticed stubborn black deposits on the SUV that just wouldn’t come off. “After three washings and two applications of lacquer thinner, it still wouldn’t come off,” McBride said.

As the safety officer, he became concerned about what kind of damage that material would do to his firefighters, their gear and perhaps their families. “It’s not all black and white being a safety officer,” he said. “There’s a lot of gray... I am OK with unsafe, but I am not OK with dangerous.” And he believes that when material with nanotechnology burns, it emits dangerous particulates. “I am not against nanotechnologies,” McBride said. “I am against us not doing anything to protect ourselves from the known dangers.”

The basic components of smoke are well known aerosols, gases and particulates, McBride said, but the new component is nanotechnology. And those new consumer products using nanotechnologies, like flat screen televisions and many items that have been powder coated, release compounds with unknown and not well understood health risks when burned.

That’s why he requires firefighters to wear SCBAs all the time, even during overhaul. It’s also because of those risks that McBride said he has his firefighters hose off their gear at the scene and then put them all in plastic bags, as if they were hazardous material, before they return to the station. Firefighters are also encouraged to clean as much of the material off their skin at the scene as possible and then bathe immediately after the fire.

Source: Firehouse

Titanium Dioxide Nanoparticles Becoming Ubiquitous in Consumer Products: What Does That Exposure Mean?

Sat, 25 Feb 2012 15:09:28 GMT

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.

NanoTiO2 Exposure is Becoming Ubiquitous

For a modern consumer it is hard to avoid titanium dioxide (TiO2) – a widely used additive in food, cosmetics, personal care products, paint, and other household products. Approximately 7 million tons of bulk TiO2 are produced annually and used as white pigment in order to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, pills, as well as most toothpastes. In cosmetic and personal care products, it is used as a pigment, sunscreen and a thickener. TiO2 also is a photocatalyst; can oxidize oxygen or organic materials directly; and is superhydrophilic. You can therefore expect to see it increasingly used in paints, glass coatings, cement, tiles and ceramics, catalysts for air and water purification.

Once ingested, the body releases the nanoparticles in feces and urine, sending them to wastewater treatment plants, which cannot prevent the smallest particles from entering lakes and rivers.

Children Likely Have Highest Ingestion Exposure

The study suggests that children may be receiving the highest exposure to TiO2 nanoparticles because sweets like candies, marshmallows and icing are among the products with the highest levels.

Study Design and Findings

According to the new study there is only one previous study, done a decade ago, reporting on titanium dioxide content in a few commercial products. To fill the knowledge gap about the sources of humans’ exposures, the researchers bought and tested food, personal care products, paints and adhesives and measured how much titanium dioxide they contain.
The study lists the names of the products tested and their titanium dioxide content. Westerhoff recommends that regulators shift their focus from the type of titanium dioxide used in paints and industrial processes to food-grade particles, because those are much more likely to enter the environment and pose a potential risk to humans and animals.

Specifically, the team analyzed titanium dioxide in foods and from food suppliers using advanced instrumentation to assess what fraction of the materials was less than 100 nm in size (whether it was aggregated or individual nanoparticles).

Distribution of primary particle size of food grade titanium dioxide (E171). Analysis indicates that 36% of the particles were less than 100 nm in at least one dimension. (Source: American Chemical Society)

For their experiments, the researchers selected a wide range of white foods from grocery stores in the U.S. Some of the foods were labeled as containing TiO2, and others were not but the primary product or surface coatings (e.g., icings) had a white color. All 89 foods were digested using microwave methods (in a beaker with hydrogen peroxide and hydrofluoric acid), and their titanium concentration was determined.

They found that roughly 36% of food-grade TiO2 (E171) consists of particles which are less than 100 nm in at least one dimension and that it readily disperses in water as fairly stable colloids.

Normalized titanium concentration in food products (top 20 products). (Source: American Chemical Society)

"Of course, exposure to titanium dioxide depends largely on dietary habits, and in special cases the exposure could be several hundreds of milligrams per day," says Westerhoff. "Because our measurements showed that roughly 36% of the particles in E171 may be in the nano range, we can presume a large exposure to nano-TiO2."

The researchers' conclusion is that it appears that pigment TiO2 represents an enormous source of nanoscale TiO2 entering sewage systems, rivers, landfills, and other sensitive environmental compartments.

"It also appears that through surface modifications food-grade TiO2 (E171) is more readily dispersed into water than other TiO2 nanomaterials – such as P25, which has been used in many environmental and toxicity studies – which potentially influences TiO2 fate, transport, and toxicity," Westerhoff notes. "Therefore, more environmental ecotoxicology and fate studies should use the fraction of smaller sized TiO2 in pigments because exposure to these materials is likely to be much higher and more representative than exposure to P25."

The research team suggests that future work should investigate other nanoscale food and personal care additives and that the research community should work towards understanding their surface chemistry and behavior in the environment.

Sources: Environmental Science & Technology and Nanowerk.com

Nanotorts Article: "Mitigating Risk In Mass Nano Torts"

Mon, 20 Feb 2012 12:42:41 GMT

You may be interested in a recent article in Product Liability Law360, February 2, 2012: "Mitigating Risk in Mass Nano Torts."

The article by attorneys Michael Lisak and James Mizgala (Sidley Austin LLP) suggests that consumer fraud (no-injury) class action claims are likely to be some of the first nanotechnology-related lawsuit faced by comapnaies making or selling nanomaterial-containing products. They suggest that the BPA plastic products liability class-action litigation can provide a useful framework for how similar nanoparticle claims may be pursued and defended.

Some excerpts are provided below, so you can decide whether to obtain the full article.

# # # #

The specter of substantial product liability exposure for companies that manufacture and employ nanomaterials demands that these companies understand the types of claims that they may face when plaintiffs begin bringing “nanotorts.” These cases may sound in traditional tort law as well as in consumer fraud, contract and medical monitoring theories of recovery.

This article examines In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation, MDL No. 1967, a putative consumer fraud class action, as a possible blueprint for the first wave of nanotechnology claims, and considers how manufacturers might defend against these actions.

Nanotorts: What Types of Claims Will Manufacturers Face?

Imagine an individual is concerned about the safety of the food stored at home in plastic containers. He or she sees a commercial touting the antimicrobial safety of a certain brand of plastic containers due to its use of a nanosilver lining. After buying and using these nanosilver containers without encountering any food safety issues for months, that person later watches a television talk show where a “B-list” celebrity claims nanosilver is associated with health and environmental hazards. After doing some internet research, this consumer is now concerned about nanosilver’s safety. What type of claim, if any, might that individual bring?

Companies that make and use nanotechnology should first be prepared to face consumer fraud class actions. The fact that some states’ consumer fraud statutes often contain provisions for the awarding of significant damages as well as attorneys’ fees will only further encourage this avenue as the likely first wave of nanotorts.

The Bisphenol-A MDL: A Blueprint for Nano-Related Litigation?

A recent putative class action involving bisphenol-A may serve as a blueprint for plaintiffs eager to assert claims in connection with nanotechnology.

In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation, MDL No. 1967, is a multidistrict litigation that includes cases involving allegations that BPA, a synthetic estrogen used to make polycarbonate plastics that comprise baby bottles, is toxic and may lead to cancer. Plaintiffs further allege that BPA is ingested when a bottle’s contents are consumed. Plaintiffs asserted claims against manufacturers of bottles and baby formula for violations of state consumer protection statutes, fraud, breach of warranty, unjust enrichment, strict product liability, breach of contract and negligence.

Thus far, the defendants have unsuccessfully argued that plaintiffs’ claims should be dismissed because plaintiffs did not sufficiently allege that they suffered damage, characterizing plaintiffs’ case as a “no-injury” products liability case. In declining to adopt defendants’ characterization of the case the court concluded that plaintiffs in this category suffered damage because they could not obtain the intended bargain or benefit from the goods. Specifically, the plaintiffs purchased a product that they allege they would not have purchased had they known the true facts. The key, according to the court, was “not that someone was injured, but that consumers were not told of BPA’s presence and the corresponding health risks. Perhaps no physical injuries resulted — but a fraud claim does not depend on a showing of physical injury.” According to the court, plaintiffs’ claims did not depend on proving the products were defective, but merely that they did not receive the benefit of the bargain.

Like the plaintiffs in the BPA MDL, our hypothetical consumer who bought plastic food containers with nanosilver could attempt to frame a claim rooted in contract law. That is, based on the BPA MDL, the consumer might allege that he or she would not have bought the product had he or she known its true nature; namely, that nanomaterials were contained within it just as BPA was a part of purchased bottles. In essence, this consumer, like the BPA MDL plaintiffs, would allege that he or she had not received the benefit of the bargain.

Framing Plaintiffs’ Claim: The Nanotechnology Manufacturer’s Strategy

Although the BPA MDL gives plaintiffs a potential roadmap to follow when initiating claims based on use of nanomaterials, it does not foreclose manufacturers from successfully framing plaintiffs’ claims as to what they really are — no-injury product liability claims. That type of claim has not tended to fare well.

For example, in Koronthaly v. L’Oreal USA Inc., 374 F. App’x 257 (3d Cir. 2010), the U.S. Court of Appeals for the Third Circuit affirmed the district court’s finding that plaintiff, a purchaser of lipstick who alleged that she was misled into purchasing unsafe, lead-laden lipstick, lacked standing to bring her claims for violation of New Jersey’s Consumer Fraud Act, breach of implied warranty, strict liability, negligence per se, unjust enrichment and injunctive relief.

The Third Circuit pointed to plaintiff’s mistaken reliance on contract law, noting that her “lipstick purchases were not made pursuant to a contract, and therefore she could not have been denied the benefit of any bargain.” Koronthaly failed to demonstrate a concrete injury-in-fact absent allegations that she received a product that failed to work as intended or was worth objectively less than could be reasonably expected.

The manufacturer of the plastic containers containing nanosilver could point to the distinction between product liability and contract claims to argue that the consumer does not have a cognizable injury and therefore does not have standing to bring a claim. The consumer has not sustained a physical injury. In fact, the storage containers are performing as advertised. The success of this argument will rise and fall, however, on the particular facts alleged in each case, as well as the analytical framework employed and facts deemed critical by the court.

Because much of manufacturers’ early litigation strategy may be driven by how artful plaintiffs craft their allegations, manufacturers should take care now to evaluate and manage risks to prevent litigation in the first place.

Conclusion: Preventing Little Things from Becoming Big Problems

As potential risks associated with nanotechnology and nanomaterials become more visible, plaintiffs’ lawyers eager for the next mass tort litigation are more than likely to turn their sights to this rapidly expanding universe of targets. In the context of potential consumer fraud actions, companies should evaluate the marketing claims and labeling associated with their products.

The increasing scrutiny of nanotechnology by regulators and media demands that companies take steps now to prepare against future liability.

Source: Law360 (www.law360.com), Michael Lisak (mlisak@sidley.com)

New Study Raises Questions About Ingested Nanoparticle Health Impacts

Tue, 14 Feb 2012 13:21:24 GMT

The use of engineered nanoparticles in food processing and pharmaceuticals is increasing, but the impact of chronic oral exposure to nanoparticles on human health remains unknown.

It has been estimated that the average person in a developed country consumes over a trillion man-made fine to ultrafine particles every day. Some features of nanoparticles may lead to harmful interactions with cellular material but few if any studies have yet addressed the chronic effects of nanoparticle exposure on the normal function of the intestinal lining, known as the epithelium.

"Oral exposure to polystyrene nanoparticles affects iron absorption", published on February 12, 2012, in the journal Nature Nanotechnology, addresses that issue.

Researchers from Cornell University found that chronic and acute oral exposure to polystyrene nanoparticles can affect iron uptake and transport in a model of human intestinal lining cells cultured in the laboratory and in a live chicken intestinal model. The study exposed chickens to high oral doses of polystyrene nanoparticles and found that those chickens absorbed less iron in their diet. The same birds also had a “remodeling” of their intestinal villi, the microscopic projections that play an important role in absorbing nutrients. The chickens were given about the same dose, weight for weight, as an adult human in a developed country would receive.

According to the paper: "The intestinal epithelial layer represents the initial gate that ingested nanoparticles must pass to reach the body. The polystyrene particles used in these experiments are generally considered non-toxic, but their interaction with a normal physiological process suggests a potential mechanism for a chronic, harmful, but subtle response."

The authors note that many of the consequences of oral nanoparticle exposure remain unknown. The results of this study suggest that intestinal uptake of calcium, copper, zinc and vitamins A, D, E and K may also be affected by high exposure to nanoparticles, although further research is needed to investigate the effects of nanoparticles on various other nutrient absorption.

The paper also notes that previous research has suggested micron- and nano-sized particles could play a role in the painful inflammatory gut disorder called Crohn's disease.

The takeaway is that there is some evidence that ingestion of some engineered nanoparticles may have negative impacts. We'll stay tuned for more research.

New Report: REACH Fails to Control Nanomaterials

Tue, 07 Feb 2012 09:42:16 GMT

REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a report published February 6, 2012, by the nonprofit Center for International Environmental Law (CIEL).

According to CIEL's David Azoulay, principal author of the report, "Three years ago, the Commission declared that REACH theoretically covered nanomaterials; but they continue to enter the EU market with little or no information on their potential risks, violating REACH's 'no data, no market' principle. The problem is that the regulation contains legal gaps and shortcomings that render it completely ineffective for nanomaterials."

Gaps in REACH for Nanomaterials?

The CIEL study identifies what it believes are four key gaps for nanomaterials in the registration phase of REACH, an essential step that requires chemical manufacturers and importers to provide key health and safety information.

1. REACH does not define nanomaterials, and contains no nano-specific provisions;
2. Most nanomaterials evade registration until 2018, yet they can still enter the EU market;
3. REACH's schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
4. REACH test guidelines fail to consider the special properties of nanomaterials.

Solutions to Close the Gaps?

The CIEL report explores possible remedies to the perceived loopholes. Some have suggested renegotiating REACH to add specific provisions on nanotechnology. But CIEL suggests that is politically impossible and could invite further weakening of the current regulation. Others have suggested changes to the technical guidance, but CIEL believes that any such proposals so far fall short of bridging the existing legal gaps.

Rather than re-opening REACH, the report proposes developing a stand-alone regulation, carefully aligned with the chemical rules, but specifically tailored to nanomaterials. According to Azoulay, "REACH could prove a useful instrument to better understand and regulate nanomaterials, provided it is coupled with a nano 'patch' that closes these inherent loopholes." Such a regulation would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.

CIEL believes this solution should be flexible and allow for future adjustments as nanomaterials are better understood, without requiring additional changes to REACH. "Flexibility must be a critical characteristic of any effort to regulate nanomaterials," says Azoulay. "Our understanding is still very limited; it will evolve, and our legal responses must be ready to do so as well. A "nano-patch" for REACH would provide that added flexibility."

For companies doing business in the EU and subject to REACH, this is an area worth watching.

About Center for International Environmental Law (CIEL)
CIEL was founded in 1989, and has offices in Washington, DC and Geneva, Switzerland. It describes itself as having a staff of international attorneys working to strengthen and use international law and institutions to protect the environment, promote human health, and ensure a just and sustainable society. For more information, see http://www.ciel.org/

Source: CIEL

EPA Extends Comment Period on Nanotube New Use Rule at Request of Unions & Other Concerned Groups

Thu, 02 Feb 2012 08:26:54 GMT

As discussed in a previous post, on December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

These new chemicals have already been allowed to go into production, but with protective measures outlined in consent orders or premanufacture notices filed by specific companies. The proposed rules adopt those conditions so they would apply to other manufacturers who want to make the substances.

The SNURs would require manufacturers to notify the EPA 90 days prior to beginning production of the intended new use, in order to give the agency time to determine if the way the manufacturers wanted to make or use the chemicals poses an unreasonable risk to people or the environment.

The new rules identify the concerns the EPA has with each of the chemicals, and the specific worker protection or protective actions required, if any. The absence of such protective measures, under the SNURs, would result in a significant new use designation.

Parties originally had until January 27, 2012, to submit comments on the proposed rules. But the EPA has indicated that it will extend the comment period, probably to March 2012, following concerns voiced by unions and other groups.

The proposed rule is the first that would require worker protection for a variety of carbon nanotubes and, says Jaydee Hanson, the policy director for the International Center for Technology Assessment, “If it's going to be the first, it's got to be right.” Groups that include the AFL-CIO, United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), International Center for Technology Assessment (ICTA), and Food & Water Watch, all wrote EPA and requested an extension to the comment period. According to the AFL-CIO, the proposed significant new use rule (SNUR), “selected personal protective equipment as the first and only means of protecting workers against exposure to carbon nanotubes [and] EPA has selected the least effective and last line of defense for worker protection.” Instead, the union argued, personal protective equipment should be the last line of defense, and used only when more effective exposure control methods are being used but have not sufficiently reduced exposures.

The subject of occupational exposure to nanoparticles has been the subject of substantial work in the past several years, and is the subject of a number of prior posts. Check them out at the Occupational Health and Safety Topic Page.

Control of Nanoscale Materials under the Toxic Substances Control Act
Many nanoscale materials are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. This four-pronged approach includes: Premanufacture notifications; a Significant New Use Rule; an information gathering rule; and a test rule.

TSCA Section 5 Significant New Use Rules
Section 5(a) of the Toxic Substances Control Act (TSCA) authorizes EPA to determine if a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2):

-The projected volume of manufacturing and processing of a chemical substance.

-The extent to which a use changes the type or form of exposure of humans or the environment to a chemical substance.

-The extent to which a use increases the magnitude and duration of exposure of humans or the environment to a chemical substance.

-The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use.

This provides EPA with an opportunity to review and evaluate the data before the submitter begins manufacturing, importing, or processing for the significant new use. EPA may then regulate the manufacture, import, or processing of that chemical substance before the initiation of the significant new use, if regulation is warranted.

NanoRelease Project – Measuring Nanoparticle Release from Products and Exposure to Workers, Consumers & Environment

Wed, 01 Feb 2012 08:19:48 GMT

A coalition of government officials, chemical manufacturers, and representatives of labor and consumer advocacy groups are working together to come up with an agreement on ways to measure whether and how multiwalled carbon nanotubes are released from products embedded or coated with MWCNTs, potentially exposing workers, consumers or the environment.

The NanoRelease project is managed by the ILSI Research Foundation Center for Risk Science Innovation and Application (RSIA) and receives funding and technical support from U.S. and Canadian agencies, as well as industry associations.

It is acknowledged that major data gaps exist on the potential for nanoparticle release from products where nanomaterials have been embedded or coated onto a solid product. But that type of information is critical for conducting real-world assessments of risk.

Some early research has suggested that multiwalled carbon nanotubes may behave like asbestos fibers if inhaled, yet the promising new material has many potential applications. Cathy Fehrenbacher, chief of the exposure assessment branch within the U.S. Environmental Protections Agency's Office of Pollution Prevention and Toxics, said, “we are very interested in the development of methods to assist us in understanding the potential for release and exposure.” Darrell Boverhof, a toxicologist with the Dow Chemical Co., and a co-chair of the group’s steering committee, said chemical manufacturers are responsible for the safety of their products, and that manufacturers hope this process will help confer confidence in the safety tests they conduct.

NanoRelease Project Objectives (from NanoRelease website):
•Provide focus to broad policy debates by working through scenarios under which specific engineered nanomaterials might be released from products;
•Examine the full life cycle of products that might act to release nanomaterials;
•Catalogue and disseminate published and unpublished data and methods (that meet minimum criteria) used to evaluate release scenarios;
•Develop “state of the science” reports about release measurement for the specific material types chosen that describe what is known and what research gaps exist; and
•Enable improvements, standardization, and widespread use of methods by carrying out tests using reference nanomaterial-matrix and positive controls in a “round robin” or similar approach.

The NanoRelease project consists of three phases:
•Phase 1: Nanomaterial Selection (COMPLETED)
•Phase 2: Methods Evaluation (IN PROGRESS)
•Phase 3: Interlaboratory Studies (BEGIN LATE 2012/EARLY 2013)

The results of the project could affect regulatory oversight, risk estimates, worker protections, and the design of multiwalled carbon nanotubes, as well as the materials that contain them.

The project is important for the nanorisk community, and worth watching closely.

Nanotorts: "A Litigator's Guide to Health and Environmental Issues"

Tue, 31 Jan 2012 09:56:23 GMT

The January 2012 issue of the Defense Research Institute’s For The Defense magazine features the nanotechnology article "A Litigator's Guide to Health and Environmental Issues," by attorney John Delany, a member of Delany & O'Brien, in Philadelphia.

Delany describes the potential for what is now a limited series of commercial, patent, and regulatory legal battles to become full-blown personal injury tort litigation in the near future. Here is an excerpt:

The factors that could create a toxic, nanolitigation storm are (1) ubiquitous exposure; (2) sympathetic plaintiffs; (3) sensational press (4) reactive politicians; (5) product identification capability pointing to a specific product or a specific defendant; (5) biomarker and causation evidence; (6) corporate culpability; (7) state-of-the art medical and liability; (8) the serious, objective, potentially permanent nature of a potential injury due to nanomaterial exposure compared with potentially subjective transitory injury; (9) deep pockets of recovery; (10) product benefit-cost utility; and (11) warnings and personal choices involved with exposure.

In addition, judicial and legislative factors may affect the liability picture, including potential immunities, economic caps, limitations on punitive damages, joint and several liability, the collateral source rule, venue shopping, removal to a federal court, preemption, and the framework that the judiciary uses to manage and adjudicate claims, such as multi-district litigation processes.

So, What Is The Latest About Nanotort Litigation Risk?

Reading Delany's January 2012 article shows that not much has yet changed – in the litigation threat arena – since I published a seminal article on the subject over three years ago: "Nanotorts: The Legal Risks of Nanotechnologies," For The Defense, November 2008.

In the ensuing 3+ years, I have provided some additional legal analyses of litigation risk for some specific product types (e.g., medical device, pharma, automotive), e.g., "Automotive Nanotechnology: Big Rewards and Big Risks from the Inconceivably Small," Westlaw Automotive Journal, November 9, 2010; "Nanotechnology: Risks & Benefits in Medical Applications," Medical Malpractice Law & Strategy, September 2009 & October 2009

I have also written about nanorisk for some specific types of claims (mass-tort claims, no-injury class action claims), e.g., "Nanoparticles: The New Frontier For Product Liability Mass Tort and Class Action Claims," published in Product Safety & Liability Reporter, December 13, 2010; Class Action Litigation Report, November 26, 2010; Toxics Law Reporter, November 11, 2010.

And I have written with some specific suggestions for nanotort risk mitigation approaches for any type of claims. E.g., "Reducing the Risk of Nanotechnology Personal Injury," ABA-TIPS General Liability and Consumer Law Committee Newsletter, Summer 2010; "8 Steps To Reducing Nanotorts In Your Nanofuture," Product Liability Law360.com, July 2010.

These articles, and others, are available at the "Articles and Presentations" page of Nanotort Law Blog. You may find something of interest there.

National Research Council Report: U.S. Nanomaterial Risk-Assessment Needs Much Improvement (01/25/12)

Mon, 30 Jan 2012 18:26:26 GMT

The federal government needs a better plan and additional funding to assess the environmental and health risks posed by nanomaterials, a National Research Council panel said in a report released on January 25, 2012.

The report, "A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials", was authored by the ad hoc NRC Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials.

The report of the 19-scientist Committee presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies – which does not currently exist.

The report warns that despite the growing prevalence of nanomaterials in consumer goods, relatively little is known about their health effects: "Despite the promise of nanotechnology, without strategic research into emergent risks associated with it -- and a clear understanding of how to manage and avoid potential risks -- the future of safe and sustainable nanotechnology-based materials, products, and processes is uncertain."

The NRC Committee found that over the last seven years there has been considerable effort internationally to identify research needs for the development and safe use of nanotechnology, including those of the National Nanotechnology Initiative (NNI), which coordinates U.S. federal investments in nanoscale research and development. But the Report concludes that "[t]here has not been sufficient linkage between research and research findings and the creation of strategies to prevent and manage any risks. Little progress has been made on the effects of ingested nanomaterials on human health and other potential health and environmental effects of complex nanomaterials that are expected to enter the market over the next decade."

Because the number of products containing nanoscale materials is expected to explode, and future exposure scenarios may not resemble those of today, selecting target materials to study on the basis of existing market size -- as is the practice now -- is problematic. To help guide research, the committee noted the following four research categories, which should be addressed within five years:

    •identify and quantify the nanomaterials being released and the populations and environments being exposed;
    •understand processes that affect both potential hazards and exposure;
    •examine nanomaterial interactions in complex systems ranging from subcellular to ecosystems; and
    •support an adaptive research and knowledge infrastructure for accelerating progress and providing rapid feedback to advance research.

A New Coordinating/Oversight Body for Federal Safety Research

The Report also calls for replacing the National Nanotechnology Initiative, which coordinates federal agencies' investments in sector research and development, with a new oversight body that has the authority to direct federal safety research. The new body should ensure that federal research is meshed with that from private business, universities and international organizations. The committee said that the current structure of the NNI -- which has only coordinating functions across federal agencies and no top-down budgetary or management authority to direct nanotechnology-related environmental, health, and safety research -- hinders its accountability for effective implementation. In addition, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. To carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential.

About the National Research Council:
The NRC study was sponsored by the U.S. Environmental Protection Agency. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are independent, nonprofit institutions that provide science, technology, and health policy advice under an 1863 congressional charter. Panel members, who serve pro bono as volunteers, are chosen by the Academies for each study based on their expertise and experience and must satisfy the Academies' conflict-of-interest standards. The resulting consensus reports undergo external peer review before completion. For more information, visit http://national-academies.org/studycommitteprocess.pdf.

Source: National Research Council

Anti-Nano Group Sues EPA To Stop Approval of Nanosilver Pesticide

Fri, 27 Jan 2012 08:33:17 GMT

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.

Nanosilver

Silver is a well-recognized antimicrobial, and being re-engineered in nanoform boosts its ability to kill bacteria. Consequently, companies have sought to use nanosilver in products as varied as workout gear (to stop odor), toothpaste (to kill bad-breath-causing bacteria) and humidifiders (to prevent mold growth). While the silver industry maintains that it’s been used safely for centuries, advocates like the NRDC are concerned about engineered nanosilver particles its uncertain impact on people and the environment. Other advocacy groups have also raised questions about nanosilver, and some academics are now making careers out of exploring the implications of the material, as I have discussed in a number of posts about the nanosilver debate over trhge past two years.

Last December, EPA granted "conditional registration" to HeiQ Materials' AGS-20 product, to be incorporated into fabrics, meaning the textiles could go on the market while the company conducts health and safety tests over the next four years. The AGS-20 product is essentially a composite of nanosilver and nanoscale silica. Part of the conditional approval was an EPA requirement for more testing on what the pesticide might mean for people, animals and the environment. But the NRDC suit, filed in federal court in California, says that’s not enough, and calls for testing before AGS-20 is sold.

The NRDC's Antipathy for Nanosilver

NRDC's press release announcing the federal suit was inflammatory: "EPA gave this company a four-year free pass to sell an inadequately tested product. EPA's approval of nanosilver is just the most recent example in a long line of decisions that treats humans and our environment as guinea pigs for these untested pesticides."

NRDC has long been part of the anti-nanotechnology crowd, publishing position papers and articles with such titles such as "Nanotechnology’s Invisible Threat: Small Science, Big Consequences," "The Promises and Pitfalls of Nanotech," and "Nanotechnologies and the Precautionary Principle."

With respect to nanosilver, the NRDC has been especially strident, stating in its blog
yesterday:

"Silver, a well-recognized antimicrobial, is highly toxic and kills both harmful and beneficial bacteria. Nanosilver is engineered from silver and marketed as an even stronger antimicrobial than silver. Because of its smaller size, nanosilver penetrates organs and tissues in the body that larger forms of silver cannot reach, like the brain, lung, and testes. That can't be good!"

Suit Timing is Interesting

The NRDC lawsuit unites two frequent advocacy-group criticisms of EPA: The agency's conditional approval program and the federal approach to nanomaterials. The suits comes on the heels of recent reports by both the EPA's inspector general and a National Academy of Sciences panel that said more attention needs to be paid to assessing the health risks posed by nanomaterials, and more funding and research needs to be devoted to it.

Coming on the heels of the recent EPA inspector general and NAS reports, and with other regulatory moves on nanomaterials percolating , the NRDC’s suit bears watching.

A New Nanomaterial Risk Assessment Tool: NanoRiskCat (NRC)

Wed, 25 Jan 2012 14:14:01 GMT

A project funded by the Danish Environmental Protection Agency (EPA), has resulted in the development of a new nanomaterial risk assessment tool called NanoRiskCat (NRC). The project's aim was to identify, categorize, and rank exposures and effects of nanomaterials used in consumer and industrial products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers, as well as nanomaterials released into the environment. The tool is a valuable step but needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept.

The project report, NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials, is 268-pages long. I've provided what I hope is a succinct, but still sufficiently robust, summary of the NRC project and report below, from the report's Executive Summary.

A New Nanomaterial Risk Assessment Tool: NanoRiskCat (NRC)

Nanomaterials are being used in a rapidly increasing number of products available for industries and private consumers. The number of nanomaterials that can be manufactured using nanotechnologies is immense and the improved material properties enable use in multiple different products. During the last decade more and more evidence has emerged in the scientific literature suggesting that some nanomaterials may have hazardous properties.

The wider goal of NanoRiskCat is to help manufacturers, down-stream endusers, regulators and other stakeholders to evaluate, rank and communicate the potential for exposure and effects through a tiered approach in which the specific applications of a given nanomaterial are evaluated. This is done by providing detailed guidance on mapping and reporting of the:

    1. Exposure potential for professional end-users
    2. Exposure potential for consumers
    3. Exposure potential for the environment
    4. A preliminary hazard evaluation for humans
    5. A preliminary hazard evaluation for the environment

A generic template for mapping and reporting these five aspects for a specific application of a given nanomaterial has been developed and is found in Appendix 1 of the report.

An assessment of the exposure potential of the use of a given nanomaterial used in a specific process or product follows a framework based on categorizing nanomaterials according to location of the material (see Figure 1 below) and grouping applications into four exposure categories:

    1. Expected to cause exposure
    2. May cause exposure
    3. No expected exposure
    4. Unclassifiable due to lack of information

NIST's announcement is available at http://www.nist.gov/mm/polymers/cnt-122011.cfm.

Material Safety Data Sheet
Manufacturers have been unsure what information to include on their MSDSs for carbon nanotubes, in light of many unknowns about the environmental, health, and safety characteristics of their materials. The NIST MSDS is illustrative only, and is not a generic document that can be used as-is to absolve companies of appropriate analysis and disclosure. NIST's illustrative MSDS does not include product-specific detail, such as safe handling procedures and personal protective equipment appropriate for a particular manufacturing process, but the NIST document can serve as the basis for manufacturers to prepare their own product-specific data sheets.

NIST's MSDS is available at https://www-s.nist.gov/srmors/view_msds.cfm?srm=2483.

About NIST: The NIST is an agency of the U.S. Department of Commerce, and SRM's are among the among the most widely distributed and used products from NIST. The agency prepares, analyzes and distributes more than a thousand different materials that are used throughout the world to check the accuracy of instruments and test procedures used in manufacturing, clinical chemistry, environmental monitoring, electronics, criminal forensics and dozen of other fields.

The Latest on Nanoparticles in Food and Food Packaging Products

Wed, 11 Jan 2012 16:07:43 GMT

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."

Food Safety News has recently suggested that the highly competitive food industry is disinclined to talk too much about its interest in using nanomaterials. But the companies are hiring scientists and engineers to craft the manmade nanoparticles to make food more flavorful, longer lasting on store shelves, bacteria resistant and easier to track, trace and monitor for spoilage.

The new Report said that because of their small size, the "intentionally engineered" nanomaterials are able to go places in the body that larger particles cannot, and it warned:
    • New "nanofood" products should only be used if safety testing ensures that there are no negative impacts on human health or the environment.
    • Current regulatory controls are inadequate to assess or ensure safety.
    • The scientific consensus is that there is a lack of knowledge regarding how nanomaterials interact at the molecular or physiological levels and their potential impacts on health and the environment.

Is FDA doing enough?

Michael Passoff, a co-author of the study, said the uncertainty and lack of transparency on the application of nanomaterial poses unnecessary risks for consumers, workers, companies, and investors.  "The FDA is not doing nearly enough," Passoff told Food Safety News, and added that federal regulators have so far ignored nano-food despite calls for reform by the Government Accountability Office.

The agency allows food producers "to determine what safety testing they should be conducting and how transparent they should be in disclosing the results of safety tests, and if they should inform consumers that they are eating these products," according to Passoff. FDA has long permitted the food industry, based solely on its own testing, to declare a food additive as GRAS, or "generally regarded as safe.''   The GRAS designation has been controversial. Nano-foods take that worry to a new level, food safety advocates said.

"FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge," the report's authors said. "Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances," according to Passoff.   "In contrast to FDA's approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed."

The report suggests that new “nanofood” products should be used only if safety testing shows they are safe for humans and the environment.

Many in the industry express frustration at FDA's failure to even establish an official regulatory definition of "nanotechnology," "nanoscale," "nanoparticles," or other related terms. FDA also has not yet weighed in on the other parameters that health experts believe can affect the toxicity of nanoparticles. They include shape, electrical charge, the ratio of surface area to volume, or other physical or chemical properties.

Sources: Food Safety News, As You Sow

Free Webinar: "Managing Nano Risk – Implementation of a Risk Management System for Nanomaterials" on 2/23/12

Fri, 06 Jan 2012 08:43:31 GMT

The Innovation Society and Marsh Risk Consulting will be holding a free webinar (English language), “Managing Nano Risk – Implementation of a Risk Management System for Nanomaterials,” on February 23, 2012.

For a company with a connection to nanomaterials, and its insurers, it is difficult to judge whether there are hidden risks to workers or customers due to uncertainty in health, safety and environmental (HSE) data. Furthermore it is difficult for a company to anticipate the future development in nanomaterials regulation globally. The webinar aims to provide useful information about those issues.

Topics
First, the webinar will provide a short overview of the present risk profile of nanotechnology and synthetic nanomaterials. Second, an enterprise-wide risk management system approach is presented, which includes the tools of "360°-risk-monitoring" and "InRiNa" (Innovation and Risk-Navigator). The system and monitoring tools are designed to provide a useful “Early-Warning-System” based on the state of science and technology.

Who should attend?
The webinar’s target audience includes:
- Producers and distributers of nanomaterials (suppliers)
- Manufacturers of nanomaterials and other products that use nanotechnology (down-stream-user)
- Retail-companies, insurance companies, investors

Speakers
- Marc Heitmann, Marsh GmbH
- Dr. Christoph Meili, Die Innovationsgesellschaft St.Gallen
- Christine Fingerhut, Marsh Risk Consulting

Registration
More information is available on the Innovation Society’s website or at
http://www.otseinladung.de/event/c4b223f185

About the Organizers

The Innovation Society Ltd., St.Gallen (Switzerland), is an international management and technology consulting company. It provides professional consulting in the area of safe and sustainable use of new technologies, risk management, strategy development and communication.

Marsh Risk Consulting is a global firm that offers customized solutions across a comprehensive range of insurable and non-insurable risks.

Source: The Innovation Society

Carbon Nanotubes & Fullerenes among Chemicals Covered by EPA Proposed New Use Rules, 12/28/11

Wed, 04 Jan 2012 10:36:18 GMT

On December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

These new chemicals have already been allowed to go into production, but with protective measures outlined in consent orders or premanufacture notices filed by specific companies. The proposed rules adopt those conditions so they would apply to other manufacturers who want to make the substances.

The SNURs would require manufacturers to notify the EPA 90 days prior to beginning production of the intended new use, in order to give the agency time to determine if the way the manufacturers wanted to make or use the chemicals poses an unreasonable risk to people or the environment.

The new rules identify the concerns the EPA has with each of the chemicals, and the specific worker protection or protective actions required, if any. The absence of such protective measures, under the SNURs, would result in a significant new use designation.

Parties have until January 27, 2012, to submit comments on the proposed rules.

First Lawsuit on Risks of Nanotechnology in Consumer Products is Filed

Fri, 23 Dec 2011 13:24:00 GMT

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.

An ICTA press release issued concurrently with filing suit on December 21, 2011, offered more of the Plaintiffs' positions concerning nanomaterial safety and their perceived failure of the FDA to act prudently in this field. Some of those comments are recounted below:

ICTA: "Nano means more than tiny; it means materials that have the capacity to be fundamentally different. Yet more and more novel nanomaterials are being sold infused into new consumer products every day, while FDA sits idly by," said George Kimbrell, ICTA Attorney. "The agency's unlawful delay unnecessarily places consumers and the environment at risk."

FOE: Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action. The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.

"Year after year goes by but we have yet to see the FDA do the bare minimum and require nanosunscreens to be labeled as such. This is a basic consumer right," said Ian Illuminato of Friends of the Earth. "We're well past the 1800s -- nobody likes or should be forced to use mystery chemicals anymore."

Since 2006, numerous studies and reports, including agency publications by the Environmental Protection Agency, the Office of the Inspector General, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials' potential effects on human health and the environment. Most troubling are studies using mice that show that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring. One study found titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain.

FWW: "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."

IATP: "The scientific consensus is that nanomaterials require specific testing to account for their novel capacities and potential risks. The FDA must do such testing as part of a pre-market safety assessment in a broader regulatory initiative to protect public health," said Steve Suppan of the Institute for Agriculture and Trade Policy.

To see the ICTA press release and a copy of the Complaint, got to
http://www.icta.org/

EU's SAFENANO and ObservatoryNANO publish new “Nanotechnology EHS Landscape” report in November 2011

Thu, 15 Dec 2011 12:39:09 GMT

On November 24, 2011, the EU's SAFENANO and ObservatoryNANO published an excellent new resource, the “Nanotechnology EHS Landscape” report. I recommend a review by anyone with an interest in nanosafety and risk issues.

SAFENANO continues to offer great up-to-date information on nano safety issues and is one of my "must-read" sites on a regular basis.

The new report provides a map and concise overview of key organizations and their activities in nanotechnology Environment, Health and Safety (EHS) issues. Activity in this sector has been growing for a decade, with multiple position papers, roadmaps, standardization committees, research groups, and significant research conducted. The literature has grown exponentially in the past 3 years in particular.

The current document is a continuation from SAFENANO and ObservatoryNANO’s earlier EHS work, and is intended to support communication of these efforts, and outline key initiatives, activities and projects within the field. The report identifies key organizations and projects, and groups them into seven major areas: research; knowledge transfer and review; standardization; guidance; regulation; public engagement; and professional bodies.

About SAFENANO
SAFENANO is Europe's Center of Excellence on Nanotechnology Hazard and Risk, based at the UK's Institute of Occupational Medicine (IOM).

About ObservatoryNANO
The ObservatoryNANO project is funded by the EC, and supports European policy makers through the provision of wide-ranging scientific and economic analysis of nanoscience and nanotechnology developments. That includes assessment of ethical and societal aspects, impacts on environment, health and safety, as well as developments in regulation and standardization. The ObservatoryNano analysis is available through three main forms of output;
• Concise "Factsheets" outlining the most exciting nanotechnology developments.
• Four page "Briefings" providing wide ranging scientific, economic, societal and risk analysis on topics of particular interest.
• "General Sector Reports" which provide more detailed scientific and technological analysis for each of the ten technology sectors.

Article: "Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It"

Fri, 09 Dec 2011 10:11:03 GMT

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.

Introduction

A key issue for risk managers to consider is how to proactively asses the use of product-related collateral material-safety data sheets, product inserts on product labels, and warnings-to inform consumers of potential health risks concerning nanomaterials in products.

As with any product, the parties in the chain of distribution of nanomaterials are deemed to possess expertise concerning the safety of their products and the component materials they contain. The law also imposes a duty upon parties in the chain of distribution to provide adequate instructions or warnings.

The creation of a proper product label, warning and/or instruction is a multi-faceted process, which requires expert consideration of material toxicity data, produce use information, the law, and human behavior.

I. Nanotechnology Product Applications and Growth

As the safety of nanomaterials and nanoenhanced products increasingly are being questioned by federal, state, and local governments, researchers, and the public, the nanotechnology industry will be facing increasing scrutiny. Most products containing nanotechnology that are currently on the market are likely to be in applications resulting in some form of human contact.

This section of the article discusses a number of subjects:
    A. Knowledge on Health Risk of Engineered Nanomaterials in Consumer Products
    B. Potential for Exposure
    C. Available Toxicity Information
    D. Potential for Health Risk

II. Legal Implications for Product Liability

All parties in the chain of manufacture, importation, distribution, and sale of nanomaterial-containing products in the United States are under duties imposed by law to produce and sell products that are free of defects in design and manufacture, and which are reasonably safe for the ordinary purposes for which the products are used. Legally adequate instructions and/or warnings are often an important part of that determination.

A. Restatement of the Law-Torts, Product Liability: Duty to Warn Generally
B. Key State Law Nuances on Duty to Warn for Nanotechnology

The article briefly discusses the law of three representative nanotechnology jurisdictions across the United States: California, Massachusetts, and New York.
    1. Massachusetts: Negligence and Breach of Implied Warranty of Merchantability
    2. California: Strict Product Liability, Negligence, and Breach of Implied Warranty of Merchantability
    3. New York: Strict Product Liability, Negligence, and Breach of Implied Warranty of Merchantability

III. Key State Law Nuances for Nanotechnology on Daubert Evidentiary Admissibility Standard

Just as with variations in the legal elements of failure to warn claims between states, not all states have followed the Daubert standard. The article briefly discusses the standard in the sample nanotechnology jurisdictions of CA, MA, and NY.

IV. Imposition of Duty to Label or Warn By Statue, Regulation or Industry Standard

The debate over international labeling guidance for manufactured nan-objects, and products containing manufactured nano-objects, has been in development for the last few years. In 2010, a draft technical standard (DTS) which would offer "guidance" for labeling of manufactured nano-objects was published. In early 2011 it was put up for a vote among member bodies of nanotechnology committees of both the European Committee for Standardization(CEN), CEN TC-352, and the International Organization for Standardization (ISO, ISO TC-229. The draft labeling guidance document was defeated by the vote.

Most recently, ISO released a new Technical Report (TR) publication "Nanotechnologies: Nanotechnology Risk Evaluation," ISO/TR 13121:2011. It sets forth a procedure "for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment." The TR is not an ISO Standard representing International consensus, or even a Technical Specification (TS), which represents a particular technical committee's consensus. A TR is an informative document as opposed to a normative one, but it may be an important due diligence reference for all manufacturers of nanomaterial-enabled products or nanomaterials.

V. Warnings Development Process

The article discusses the general principles of good warning and instruction design practice, recognizing that there are important differences depending on the classification of products into either consumer or industrial uses.

    A. Consumer Products
    B. General ANSI Standards Related to Warning and Labeling: American Standards
    C. General International Standards Related to Warning and Labeling: ISO Standards
    D. General Industrial or Occupational Warning Compliance and Assessment

VII. Conclusion

Regardless of the nature of the nanomaterials to be considered, prudence dictates that while the development of nanomaterial toxicity data concerning human health and the environment is an on-going and a dynamic process, all parties in the chain of nanomaterial product and nanomaterial distribution should undertake serial risk analysis, and cradle-to-grave product risk assessment, in order to decide whether the unique circumstances surrounding their products at any given time, compel the development of safety instructions, labels or product warnings as a means of promoting both consumer safety and risk management. The development of proper warnings and/or labeling is a multidisciplinary process that should include careful input from risk managers, engineers, industrial hygienists, toxicologists and qualified legal counsel.

For more information, authors Rogers and Clark can be contacted at wsrogers@daypitney.com and jclark@daypitney.com, and authors Tsuji, Dahlstrom, and Arndt can be contacted at tsujij@exponent.com, ddahlstrom@exponent.com, and sarndt@exponent.com.

Source: BNA Product Safety & Liability Reporter

New research suggests potential link between cancer and nano-sized zinc oxide, a nanomaterial widely used in consumer products

Thu, 01 Dec 2011 08:42:20 GMT

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.

The research findings were published in this month’s edition of Biomaterials, a leading journal in the field of biomaterials research.

The study is led by Assistant Professor Joachim Loo, 34, and Assistant Professor Ng Kee Woei, 37, from NTU’s School of Materials Science and Engineering. They worked with Assistant Professor David Leong, 38, from the Department of Chemical and Biomolecular Engineering, National University of Singapore, a joint senior author of this research paper.

The findings suggest that companies may need to reassess the health impact of ZO nanoparticles used in consumer products. More studies are also needed on the issue of exposure, i.e., the concentration levels of ZO nanomaterials in consumer products and frequency of use.

“Currently there is a lack of information about the risks of the nanomaterials used in consumer products and what they can pose to the human body. This study points to the need for further research in this area and we hope to work with the relevant authorities on this,” said Asst Prof Loo. Asst Prof Ng said the team will carry out further research as the DNA damage brought about by nano-sized Zinc Oxide particles is currently a result of an unknown mechanism. But what is clear is that besides causing DNA damage, nanoparticles can also cause other harmful effects when used in high doses.

“From our studies, we found that nanoparticles can also increase stress levels in cells, cause inflammation or simply kill cells,” said Asst Prof Ng who added that apart from finding out the cellular mechanism, more focused research is also expected to ascertain the physiological effects and damage that nano-sized ZO particles can cause.

About Nanyang Technological University:
NTU is the main science and technology university in Singapore and is a research-intensive university with globally acknowledged strengths in science and engineering.

New Study Shows Nanoparticles Being Used as Additives in Diesel Fuels Can Travel from Lungs to Liver and Could Cause Liver Damage

Mon, 21 Nov 2011 13:03:16 GMT

Researchers at Marshall University's Center for Diagnostic Nanosystems have demonstrated that nanoparticles of cerium oxide (CeO2), a common diesel fuel additive used to increase fuel economy, can travel to the lungs and from the lungs to the liver, potentially causing liver damage.

The data in the study by Dr. Eric R. Blough and his colleagues indicate there is a dose-dependent increase in the concentration of cerium in the liver of animals that had been exposed to the nanoparticles. These increases in cerium were associated with elevations of liver enzymes in the blood and histological evidence consistent with liver damage. The research was published in the October 13, 2011, issue of the peer-reviewed research journal International Journal of Nanomedicine.

Cerium oxide is widely used as a polishing agent for glass mirrors, television tubes and ophthalmic lenses. Cerium oxide nanoparticles are used in the automobile industry to increase fuel efficiency and reduce particulate emissions. Some studies have found that cerium oxide nanoparticles may also be capable of acting as antioxidants, leading researchers to suggest these particles may also be useful for the treatment of cardiovascular disease, neurodegenerative disease and radiation-induced tissue damage.

Dr. Blough, the Center’s director and an associate professor in the university’s Department of Biological Sciences, said, "The interesting thing is that it appears that these particles, if they are inhaled, can travel outside of the lung and to other organs," Blough said. "This is an animal study, so we still have a long way to go, but it appears that inhaled cerium oxide nanoparticles could lead to liver damage. What we found was histological evidence of changes at the cellular level and in changes of some of the enzymes in the blood that are predictive of liver damage."

Blough said he and the other research attempted to mimic the potential effects of exposure over decades. "The reason that we did that was that it's possible that these particles could accumulate over time," he said.

"Given the ever-increasing use of nanomaterials in industry and in the products we buy, it is becoming increasingly important to understand if these substances may be harmful," Blough said. "To our knowledge, this is the first report to evaluate if inhaled cerium oxide nanoparticles exhibit toxic effects in the liver."

Dr. Siva K. Nalabotu, the study’s lead author and a Ph.D. student in Blough’s lab, said, “The potential effects of nanomaterials on the environment and cellular function is not yet well understood. Our studies show that cerium oxide nanoparticles are capable of entering the liver from lungs through the circulation, where they show dose-dependent toxic effects on the liver. Our next step is to determine the mechanism of the toxicity.”

The research was supported with funding from the U.S. Department of Energy.

Sources: Marshall University Research Corporation and International Journal of Nanomedicine

New EC project to develop reference methods for managing risks of engineered nanomaterials

Thu, 10 Nov 2011 08:03:35 GMT

SAFENANO, Europe's Centre of Excellence on Nanotechnology Hazard and Risk, along with the Institute of Occupational Medicine (IOM), have announced the official launch of the European Research project MARINA (MAnaging RIsks of NAnoparticles).

While there are standard procedures for product life cycle analysis, exposure, hazard, and risk assessment for traditional chemicals, it is not yet clear how these procedures need to be modified to address all the novel properties of nanomaterials. There is still an acute need to develop specific reference methods for all the main steps in managing the potential risk of ENM. The aim of MARINA is to develop such methods.

MARINA will address the four central themes in the risk management paradigm for ENM:
1. Materials;
2. Exposure;
3. Hazard; and
4. Risk

The methods developed by MARINA will be (i) based on beyond-state-of-the-art understanding of the properties, interaction and fate of ENM in relation to human health and the quality of the environment and will either (ii) be newly developed or adapted from existing ones but ultimately, they will be compared/validated and harmonized/standardized as reference methods for managing the risk of ENM.

MARINA will develop a strategy for Risk Management including monitoring systems as well as measures for minimizing massive exposure via explosion or environmental spillage.

The 4 year FP7 project is led by Dr Lang Tran of the Institute of Occupational Medicine in Edinburgh, and involves collaboration by 47 different scientific and industrial partners.
The MARINA project officially began on November 1, 2011, although the project's formal launch meeting will take place in Rome November 16-18, 2011.

Source: SAFENANO

2011 U.S. Gov't Nanomaterial EHS research strategy to focus on complete Life-Cycle Assessment

Tue, 01 Nov 2011 11:53:03 GMT

The National Nanotechnology Initiative (NNI)'s latest environmental, health, and safety research strategy, published in October 2011, highlights what has become a risk assessment focus within the world of nano safety: The need to look at the entire impact of an application or product, from the workers who manufacture it to how the consumer uses it to the way it’s disposed of.

With this latest plan for tracking environmental health and safety issues in the burgeoning nanotechnology field, the NNI is stepping up the call for more research, better data and more pointed efforts to educate the public. The plan focuses on human exposure, human health and the environment, incorporating risk assessment and management, the development of predictive models and the measurement of nanomaterials into that matrix. It calls for better ways to characterize the super-small materials that are increasingly found in consumer products, as well as testing them to identify potential hazards. (Read the administration’s blog post about the report here.)

“We have focused on a life-cycle assessment,” said Treye Thomas of the Consumer Product Safety Commission, who co-chaired the committee that helped put the new NNI research strategy together. Thomas spoke, with other federal officials and some industry representatives, during an NNI-hosted webinar on October 20 unveiling the document. Note: See my October 20 blog post on the subject.

Looking at “life cycles” is something nano-safety advocates have been urging. Thus far, toxicological research on nanomaterials has tended to focus on a single substance (e.g., nanosilver particles) with a specific exposure and at a particular point in time/product use. For example, some testing of consumer products is being done—like setting a nano-flame retardant on fire and seeing what’s released—but there’s very little information about what happens if you incinerate a smartphone that has carbon nanotubes incorporated into its circuits.

“We need to recognize that this is going to be a big hill to climb,” Shaun Clancy of the Evonik Degussa Corp. said of the effort to understand life-cycle issues. Clancy spoke at the webinar as a general representative of the industry perspective.

Lynn Bergeson, a lawyer who works on nano regulatory issues (and authors a well-read blog on the subject) called the life-cycle emphasis “extremely important” and said it “enhances the document and makes it even more relevant to the public and to public health.”

Sources: NNI, New Haven Independent

Federal Government Releases Environmental, Health, & Safety Research Strategy for Nanotechnology

Thu, 20 Oct 2011 08:12:26 GMT

The United States National Nanotechnology Initiative (NNI) this week released its 2011 NNI Environmental, Health and Safety (EHS) Research Strategy, which provides an integrated research framework meant to guide all federal agencies participating in NNI.

Six core categories of research were identified:

1. Nanomaterial Measurement Infrastructure
2. Human Exposure Assessment
3. Human Health
4. Environment
5. Risk Assessment and Risk Management
6. Informatics and Modeling.

The strategy also aims to address the various ethical, legal, and societal implications of this emerging technology.

The strategy is grounded in the principles of risk assessment and product life cycle analysis, so as to measure risk at every stage of a product’s development, from preliminary handling of raw materials to final disposal of finished products.

According to Dr. Sally Tinkle, NNI EHS Coordinator and Deputy Director of the National Nanotechnology Coordination Office (NNCO), “The EHS Research Strategy provides guidance to all the Federal agencies that have been producing gold-standard scientific data for risk assessment and management, regulatory decision making, product use, research planning, and public outreach. This continues a trend in this Administration of increasing support for nanotechnology-related EHS research, as exemplified by new funding in 2011 from the Food and Drug Administration and the Consumer Product Safety Commission and increased funding from both the Environmental Protection Agency and the National Institute of Occupational Safety and Health within the Centers for Disease Control and Prevention.”

To review the strategy and to see a video webinar that was held on October 20 in conjunction with the release of the strategy, go to http://www.nano.gov/node/695

Carbon Nanotubes: New Study Suggests They Pose Occupational Health Risk

Thu, 16 Jun 2011 08:32:27 GMT

A new study published in the June 2011 issue of The American Journal of Pathology, "Length-Dependent Retention of Carbon Nanotubes in the Pleural Space of Mice Initiates Sustained Inflammation and Progressive Fibrosis on the Parietal Pleura", shows that carbon nanotubes could pose risks in the occupational setting. The study was conducted by the University of Edinburgh, United Kingdom, and follows previous research in mice looking at the effect of carbon nanotubes on the stomach cavity.

Similarities with asbestos
Most CNTs have extremely high aspect ratios (length-to-diameter), some in excess of 10,000 (imagine an ordinary needle, but that is the length of a 40 story building). Research in mice found that short nanotubes appeared to be relatively harmless if they entered the lung cavity. But longer carbon nanotubes caused a reaction in the lung lining similar to that of asbestos. Longer nanotubes were more likely to get stuck in the lungs, leading to the conclusion that they could ultimately cause diseases including mesotheliom, a cancer form that previously has been associated only with asbestos.

Finding safest kind of nanotube
Carbon nanotube use is growing rapidly in the materials science field because of their superpowers. CNTs have 100 times the strengh of steel, conduct heat better than a diamond, and carry electricity better than copper. But early studies of carbon nanomaterial toxocity have produced apparently conflicting results and have raised more questions than they answered. As a result, there is near-universal consensus amongst scientists that significantly more work is needed to adequately assess the toxicity and hgelath risks of new carbon nanomaterials, including CNTs. The most recent study demonstrates the need for industry to design safe nanofibers that are long enough to be useful but short enough to avoid causing disease.

Need for further risk assessment
"The industrial-scale manufacture of carbon nanotubes is increasing, with a global market in excess of £1 billion. This research shows that there is a potential hazard in the manufacture of certain types of carbon nanotubes" says Ken Donaldson, Professor of Respiratory Toxicology. Researchers are looking at assessing the level of risk involved, for instance examining how many of the long fibres are present in the air at workplaces.

Source: University of Edinburgh

New EPA Policy on Regulating Pesticides that Use Nanotechnology - June 2011

Wed, 15 Jun 2011 12:27:28 GMT

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: Given the potential for nanoscale materials to pose different risks than their larger-sized counterparts, the EPA intends to gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

A number of organizations, as well as government, academic and private sector scientists, have considered whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment.

EPA also recognizes that nanoscale materials have a range of potentially beneficial public and commercial applications, including pest control products. The agency will continue to encourage responsible and innovative development of products containing nanoscale materials to realize these benefits while also addressing health or environmental concerns.

The new proposed policy options will be published in the Federal Register shortly. The notice will also propose a new approach for how EPA will determine whether a nanoscale ingredient is a “new” active or inert ingredient for purposes of scientific evaluation under the pesticide laws, when an identical, non-nanoscale form of the nanoscale ingredient is already registered under FIFRA. This approach will help ensure that EPA is informed about the presence of nanoscale ingredients in pesticide products and allows a more thorough review of the potential risks.

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197.

Source: EPA

Nanofoods Update – June 2011

Mon, 13 Jun 2011 09:33:38 GMT

Nanotechnologies are being applied rapidly in food industries worldwide. A fresh review article of that growth is available in the article "Nanotech: Propensity in Foods and Bioactives," published in Critical Reviews in Food Science and Nutrition in June 2011.

Applications in food industries include molecular synthesis of new functional food compounds, innovative food packaging, food safety and security monitoring. This review article covers the use of biopolymers in the production of nanomaterials and the propensity of nanotechnology in food and bioactives.

The extensive use of nanotechnology has led to the need for paralleled safety assessment and regulations to protect public health and environmental adverse effects. The exposure routes of nanoparticles, safety challenges and measures undertaken to ensure optimal benefits that outweigh detriments are also discussed.

The article observes that new nanomaterials are constantly being developed from both (1) natural biodegradable polymers of plant and animal origins (such as polysaccharides and derivatives, peptides and proteins, lipids and fats), and from (2) biocompatible synthetic biopolyester polymers (such as polylactic acid (PLA), polyhydroxyalkonoates (PHA) and polycaprolactone (PCL)).

Bioactives relevance includes targeted delivery systems with improved bioavailability using nanostructure vehicles such as association colloids, lipid based nanoencapsulator, nanoemulsions, biopolymeric nanoparticles, nanolaminates and nanofibers.

Note: Critical Reviews in Food Science and Nutrition is a highly respected journal, published since 1970, that presents critical viewpoints and scientific discoveries related to nutrition, food safety, and food science and technology.

FDA Finally Takes First Step Toward Regulating Nanotechnology

Fri, 10 Jun 2011 15:23:08 GMT

On June 9, 2011, the U.S. Food and Drug Administration announced a draft Guidance for Industry about the use of nanotechnology by industries the agency regulates, calling it the “first step” in determining whether products contain the emerging technology.

The draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.

FDA is releasing its document in coordination with the "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials" issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

The guidance is intended for manufacturers, suppliers, importers and other stakeholders. The guidance describes FDA’s current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

This guidance document does not establish any regulatory definitions. Nor does this guidance document address the regulatory status of products that contain nanomaterials or otherwise involve the application of nanotechnology, which are currently addressed on a case-by-case basis using FDA’s existing review processes.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

FDA will develop additional guidance documents related to specific products or product categories in the future, as needed and consistent with the "Principles for Regulation and Oversight of Emerging Technologies" released March 11, 2011.

While the guidance does not create a regulatory definition for nanotechnology, it intends to give industry stakeholders an idea of the FDA's thinking as it identifies whether regulated products contain this technology. “With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, the FDA commissioner. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

The FDA says the draft guidance, currently open to public comment, lists certain characteristics and properties of nanomaterials that can be considered when identifying the use of the technology in regulated products. Nanotechnology can be used in cosmetics, drugs to increase a type of absorption into the body and improving food packaging, according to the FDA.

“It is critical for FDA to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, effectiveness, performance or quality of a product that contains such materials,” the FDA said in its announcement.

These characteristics include the size of the nanomaterials used, whether the material is natural or engineered into the product and whether the exhibited properties of the material are attributable to its small size.

The FDA said that, once the guidelines are finalized, it will apply them to regulated products during premarket review to better understand the materials' properties and behavior.

For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in a product's development process “so questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed,” the agency said in its announcement.

The FDA drafted the guidance following a 2007 task force report that recommended the agency address potential risks and benefits of regulated products that use nanotechnology.

For more information:

Questions and Answers:
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm258391.htm

FDA's Nanotechnology Web Page:
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm

Source: FDA

New Technique Could Improve Nanoparticle Safety Assessment

Thu, 09 Jun 2011 09:21:47 GMT

Depending on whom you ask, nanoparticles are, potentially, either one of the most promising or the most perilous creations of science. Studying potential nanotoxicity presents significant challenges, in part due to the lack of accepted study techniques. Scientists at the National Institute of Standards and Technology (NIST) appear to have found a way to manipulate nanoparticles so that questions like this can be answered. (D.R. Reyes, G.I. Mijares, B. Nablo, K.A. Briggman and M. Gaitan. "Trapping and release of citrate-capped gold nanoparticles," Applied Surface Science, May 27, 2011.)

The NIST team has developed a method of attracting and capturing metal-based nanoparticles on a surface and releasing them at the desired moment. The method, which uses a mild electric current to influence the particles' behavior, could allow scientists to expose cell cultures to nanoparticles so that any lurking hazards they might cause to living cells can be assessed effectively.

The method also has the advantage of collecting the particles in a layer only one particle thick, which allows them to be evenly dispersed into a fluid sample, thereby reducing clumping—a common problem that can mask the properties they exhibit when they encounter living tissue. According to NIST physicist Darwin Reyes, these combined advantages should make the new method especially useful in toxicology studies.

"Many other methods of trapping require that you modify the surface of the nanoparticles in some way so that you can control them more easily," Reyes says. "We take nanoparticles as they are, so that you can explore what you've actually got. Using this method, you can release them into a cell culture and watch how the cells react, which can give you a better idea of how cells in the body will respond."

Other means of studying nanoparticle toxicity do not enable such precise delivery of the particles to the cells. In the NIST method, the particles can be released in a controlled fashion into a fluid stream that flows over a colony of cells, mimicking the way the particles would encounter cells inside the body—allowing scientists to monitor how cells react over time, for example, or whether responses vary with changes in particle concentration.

For this particular study, the team used a gold surface covered by long, positively charged molecules, which stretch up from the gold like wheat in a field. The nanoparticles, which are also made of gold, are coated with citrate molecules that have a slight negative charge, which draws them to the surface covering, an attraction that can be broken with a slight electric current. Reyes says that because the surface covering can be designed to attract different materials, a variety of nanoparticles could be captured and released with the technique.

Progress.

Source: National Institute of Standards and Technology (NIST), an agency of the U.S. Department of Commerce.

Current Developments/Activities on the Safety of Manufactured Nanomaterials

Tue, 07 Jun 2011 09:53:37 GMT

A recent document from the Organization for Economic Co-operation and Development (OECD), “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” provides an update on current developments and activities regarding the safety of manufactured nanomaterials in OECD member countries, and other delegations that attended the 8th meeting of the OECD’s Working Party on Manufactured Nanomaterials, held in Paris, France from March 16 to 18, 2011.

The document includes written reports on current activities related to nanotechnologies and nanomaterials in other international organizations, such as the International Organization for Standardization, the Food and Agriculture Organization of the United Nations, and the World Health Organization. This resource is intended to provide delegations and other stakeholders with a “snapshot” (current to March 2011) of information on activities related to manufactured nanomaterials, as well as other nanotechnology activities, at the national and international level.

OECD member countries have been very active in the nanomaterial safety field and this report is an excellent summary report that will get a reader up to speed on issues including discussion of the current nanoparticle risk assessment status.

ABOUT THE OECD

The Organization for Economic Co-operation and Development (OECD) is an intergovernmental organization in which representatives of 34 industrialized countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonize

policies, discuss issues of mutual concern, and work together to respond to international problems. The Environment, Health and Safety Division publishes documents in several different series, including Safety of Manufactured Nanomaterials. More information about the Environment, Health and Safety Programme and EHS publications is available on the OECD’s web site (www.oecd.org/ehs/).

Source: OECD

Progress on Defining “Nanomaterial” for Regulatory Purposes

Mon, 06 Jun 2011 16:06:35 GMT

The recent EU Cosmetic Products Regulation includes a labeling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice. Similar provisions are now being considered for other regulations/ directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials.

The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term ‘nanomaterial’. This need is also acknowledged by a European Parliament resolution from 20090 which has called for a comprehensive science-based definition in Community legislation.

An excellent discussion of the subject, and real progress on the issue, is reflected in a new European Commission Reference Report, “Considerations on a Definition of Nanomaterial for Regulatory Purposes.”

The Report -- from the EC’s Joint Research Centre (JRC), Institute for Health and Consumer Protection -- reviews and discusses issues related to a definition of the term ‘nanomaterial’. It gives a short overview about what may be considered as nanomaterials, their novel properties and applications. The important need for a definition of nanomaterial is discussed, and the question of what should be achieved by a definition is addressed.

The Report provides a very good overview of definitions by international, national and European institutions, and lists approaches used in European legislation. It summarizes the advantages and shortcomings of different elements typically used in available definitions, regarding their applicability in a regulatory context.

The Report concludes that a definition of the term ‘nanomaterial’ for regulatory purposes, only should concern ‘particulate nanomaterials’. The definition should ideally be broadly applicable in EU legislation and in line with other approaches worldwide.

The following three key elements are identified as being crucial: (i) the term ‘material’, (ii) the nanoscale, and (iii) specific nanoscale properties. ‘Material’ and ‘nanoscale’ should both preferably be defined precisely in order to ease enforceability. This implies the introduction of precise nanoscale limits and instructions on how such limits can be applied to nanoscale materials with size distributions. For a basic and clear definition, which is broadly applicable and enforceable, it is recommended not to include properties other than size in a general definition. Shape and state of agglomeration/aggregation must be adequately dealt with either in the definition or in subsequent legislation. Other issues may need to be considered in specific regulations such as origin of the nanomaterial, properties other than size, and specific inclusion or exclusion of certain nanomaterials.

About the JRC-IHCP: The Institute for Health and Consumer Protection (IHCP) is one of the seven scientific institutes of the Joint Research Centre (JRC) of the European Commission. The mission of the JRC-IHCP is to protect the interests and health of the consumer in the framework of EU legislation on chemicals, food, and consumer products by providing scientific and technical support, including risk-benefit assessment and analysis of traceability.

Source: European Commission

Safety of Nanoparticles in Food Crops Is Still Unclear

Fri, 03 Jun 2011 10:18:57 GMT

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.

Turning to NMs specifically, the uptake of carbon-based (CB) and metal-based (MB) NMs by plants is a very recent field of study and the article observes that very few NMs and plant species have been studied, mainly at the very early growth stages of the plants. Very few references describe the biotransformation of NMs in food crops, and the possible transmission of the NMs to the next generation of plants exposed to NMs is unknown. The possible biomagnification of NPs in the food chain is also unknown. Among CB NMs, the most studied materials are the carbon nanotunbes and the C70 fullerene. The most studied MB NMs are TiO2, CeO2, Fe3O4, and ZnO NPs. All of these CB and MB NMs are in commercial use already.

This literature review is interesting and helpful. It confirms that knowledge on plant toxicity of ENMs is at the basic foundation stage. Practically, there are no conclusive studies on the nanotoxicity. The article concludes by noting that the new field of nanoecotoxicology has emerged to address the effects of ENMs on the living components of ecosystems, which includes nanoagriculture.

Source: The American Chemical Society

New ISO Guidance for Nanomaterial Risk Evaluation

Wed, 18 May 2011 15:19:10 GMT

The International Organization for Standardization (ISO) has released a new publication, "Nanotechnologies: Nanotechnology Risk Evaluation," ISO/TR 13121:2011, which describes a process for “for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.”

The publication also offers guidance about making sound risk evaluations and risk management decisions, and information on how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices.

Also included are methods to update assumptions, decisions and practices as new information becomes available – which is almost continuously in the nanomaterial EHS field. Additionally, the document describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials, for transparency and accountability.

Source: International Organization for Standardization

Nanofood Safety – European Food Safety Authority publishes first practical guidance for assessing nano-applications in food & feed

Mon, 16 May 2011 15:50:58 GMT

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. Importantly, the ENM guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorisation in food and feed. It stipulates the additional data needed for the physical and chemical characterisation of ENM in comparison with conventional applications and outlines different toxicity testing approaches to be followed by applicants.

Commenting on the publication of the EFSA guidance, Professor Vittorio Silano, Chair of EFSA’s Scientific Committee explained, “A thorough characterisation of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications. Yet we recognise uncertainties related to the suitability of certain existing test methodologies and the availability of data for ENM applications in food and feed. The guidance makes recommendations about how risk assessments should reflect these uncertainties for food and feed applications.”

To assist with the practical use of the guidance, six scenarios are presented which outline different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required.

EFSA conducted a public consultation on its preparatory work, acknowledging the importance of developing risk assessment methodologies in this field to support innovation whilst ensuring the safety of food and feed. In total 256 comments were received from 36 organizations spanning from academia, NGOs, industry to Member State and international authorities. All of these contributions were considered and incorporated into the guidance document.

Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.

About EFSA: The European Food Safety Authority (EFSA) was set up in January 2002, following a series of food crises in the late 1990s, as an independent source of scientific advice and communication on risks associated with the food chain. EFSA’s independent scientific advice underpins the European food safety system.

Source: EFSA

New Study Raises More Concerns About Ecotoxicity of TiO2 and ZnO Nanoparticles – Negative Effects on Food Crop Growth?

Thu, 12 May 2011 17:19:21 GMT

A new study of popular nano-metal oxides was just published in the April 2011 issue of the Journal of Environmental Monitoring, a publication of the highly-respected Royal Society of Chemistry. The RSC is the largest organization in Europe for advancing the chemical sciences.

The article, “TiO2 and ZnO nanoparticles negatively affect wheat growth and soil enzyme activities in agricultural soil”, summarizes findings on the effects of titanium dioxide and zinc oxide nanoparticles on wheat growth and soil enzyme activities under actual field conditions. According to the authors, the increased use of nanoparticles has raised concerns about their possible harmful effects within the environment, but most studies have been in aqueous systems – not actual field conditions.

This new study found that both of the nanoparticles reduced the biomass of wheat. The TiO2 nanoparticles stayed in the soil for long periods and primarily adhered to the cell walls of wheat. The ZnO nanoparticles dissolved in the soil, enhancing the uptake of the nanoparticles by the wheat. Significant changes were also induced in soil enzyme activities. These enzymes are bioindicators of soil quality and health, and soil protease, catalase, and peroxidase activities were all inhibited in the presence of nanoparticles, although urease activity was unaffected.

The authors conclusion: “The nanoparticles themselves or their dissolved ions were clearly toxic for the soil ecosystem.”

Source: RSC Publishing

NIOSH: Nano-Titanium Dioxide “A Potential Occupational Carcinogen”

Tue, 10 May 2011 09:54:58 GMT

In a set of recommendations that could have far-reaching implications, the National Institute for Occupational Safety and Health has concluded that airborne super-small particles of titanium dioxide “should be considered a potential occupational carcinogen.”

A recently released NIOSH guidance document (NIOSH, 2011) on handling titanium dioxide (TiO2) powders in the workplace has generated a high level of interest as it puts forward an innovative approach that might have implications beyond TiO2.

The new document outlines the agency’s suggestions for exposure levels that will avoid long-term problems. The bulletin is discussed in some detail at the CDC/NIOSH Science Blog.

What is the Significance? Size Really Does Matter
For the first time, the NIOSH recommendations make a specific distinction between inhaling very small particles of titanium dioxide—the agency refers to them as “ultrafine”—and larger particles. After reviewing numerous studies about titanium dioxide, NIOSH scientists concluded that the ultrafine particles are more worrisome. This document could also be proactively be used for how other poorly soluble, low toxicity (PSLT) particles are controlled in the workplace.

The bulletin is emphatic that the “conclusions derived here should not be inferred to pertain to nonoccupational exposures,” and that the recommendations involve only airborne particles, which can be inhaled into the lungs. Titanium dioxide is widely used in commercial products, including paint, toothpaste and sunscreen, although generally in formulations that would make it very difficult to inhale the material.

NIOSH’s approach—seeing size, and surface area, as the prime driver for whether a material is hazardous—is “I think more clearly stated and defended and justified here than I’ve seen before,” said Richard Denison, a senior scientist at the Environmental Defense Fund who closely follows regulatory policy involving nanomaterials.

NIOSH, a division of the Centers for Disease Control, has been in the forefront of nano-related policy, at least where workplace safety is concerned. The new guidelines on titanium dioxide have been in the works since 2005. Late last year, the agency released a draft version of a similar document on occupational exposure and carbon nanotubes; a final version is expected soon.

For airborne titanium dioxide, NIOSH’s recommendation is a limit of 2.4 milligrams per cubic meter of air for larger particles, and .3 milligrams per cubic meter for air for “ultrafine” or nano-sized particles, defined as under 100 nanometers in size (that figure is the traditional threshold for a substance to be considered a nanoparticle). Those exposures are predicated on a 10-hour day during a 40-hour workweek, according to the recommendations.

Charles Geraci, coordinator of NIOSH’s Nanotechnology Research Center, said the agency’s recommendations are focused on the safety of those who are exposed to titanium dioxide during manufacturing, not while using consumer products. Geraci said that while NIOSH is targeting manufacturers and workers with these guidelines, the agency can and does “collaborate and cooperate” with regulators that have jurisdiction over everyday products. “We have been in discussions with other government agencies who do have broader consumer or public health responsibility,” he said.

The International Agency for Research on Cancer, an arm of the World Health Organization, classifies titanium dioxide as a possible human carcinogen. NIOSH reached its own conclusion separately, Geraci said. He said that while the agency has made research on nanoparticles a priority, scientists weren’t necessarily expecting to find the distinctions among different sizes of titanium dioxide particles. “You do see a difference and there is a different correlation,” Geraci said.

Philip Lippel, a member of the advisory board for the NanoBusiness Commercialization Association, an industry group, said the NIOSH recommendations should come as a relief to manufacturers. The report says that the hazards of exposure can be controlled through conditions that are “relatively readily obtained,” he said. Those methods are probably already in place in most, if not all, manufacturing plants, he said. “This thing makes pretty clear that there’s no toxicity in any method except inhalation,” Lippel said.

The regulation of nanomaterials is almost nonexistent. According to critics, that’s mostly because the laws are aimed at evaluating chemicals, not different forms of a substance. If size determines what a substance does inside the body of people or animals, or in the air, soil, or water, then their logic is that a regular-sized particle may be fine, but a nano-sized one is not. The NIOSH recommendations reflect that thinking, Denison said. “This is reinforcing that actually risks that fall along a continuum but are greatly exacerbated as you get to smaller and smaller particle sizes are relevant and do require a different approach,” he said.

What will be the impact of the NIOSH document?
The NIOSH Current Intelligence Bulletin on TiO2 reflects increasing attention to evaluating and mitigating risks of emerging hazards in the workplace before adverse health effects occur in workers. This change could be considered as a transition from a reactive to proactive paradigm in occupational risk management.

Source: CDC/NIOSH

Nano Governance: The Current State of Federal, State, and International Regulation – May 19, 2011

Fri, 06 May 2011 16:46:00 GMT

Two Sections of the American Bar Association are presenting a half-day program that may be of interest to you. “Nano Governance: The Current State of Federal, State, and International Regulation,” is being presented as a webinar and for attendance at several host sites on Thursday, May 19, 2011, at 1:00 p.m. – 5:30 p.m. Eastern Time.

A number of knowledgeable experts have been lined up to speak by the co-sponsoring Section of Science and Technology Law: Nanotechnology Committee (of which this blogger is a member) , and Section of Environment, Energy, and Resources: Pesticides, Chemical Regulation and Right-to-Know Committee.

The program brochure is available here. A program overview and educational objectives are shown below.

Program Overview:

States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. At the same time companies globally continue to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. The program is open to attorneys and other professionals with chemical regulatory compliance practices. Participants may join the program by webinar or attend host sites, free of charge, in Washington, DC, San Francisco, CA, and Durham, NC.

Educational Objectives:

• Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies;

• Understand potential public health and environmental impacts and the approaches various government agencies are pursuing to promote nanotechnology while also addressing potential public health and environmental risks; and

• Appreciate complexities of addressing potential risks with existing governance tools and strategies while also embracing new approaches to accommodate evolving technologies.

For online registration and more information, go to:
http://www2.americanbar.org/calendar/nr1105-nano-governance/Pages/default.aspx

Source: American Bar Association

Article: "Nanotechnology Manufacturers' Duty to Warn and Potential Affirmative Defenses"

Sat, 30 Apr 2011 09:57:06 GMT

You may be interested in an article published by BNA's Product Safety & Liability Reporter in April 2011: "Nanotechnology Manufacturers' Duty to Warn and Potential Affirmative Defenses."

The well-written article, by attorneys James W. Mizgala and Michael L. Lisak (Sidley Austin LLP in Chicago), assesses a manufacturer's duty to warn of potential dangers posed by nanomaterials, and then offers suggestions for defenses that could be raised by nanomaterial defendants facing failure to warn claims.

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

Duty to Warn

Future plaintiffs will almost certainly argue that manufacturers of nanomaterials knew, or should have known, of the potential risks of their products, triggering a duty to warn adequately unsuspecting end-users of those risks.

What a future jury may find as an adequate warning is particularly challenging to predict within the nanotechnology context given that “nanotechnology” encompasses scores of different materials used in a myriad of different products. Thus, manufacturers will not be able to rely on a blanket warning for all products containing nanomaterials.

As the “state of the art” of nanotechnology evolves over time, so does our understanding of its corresponding risks and benefits. Thus, manufacturers must stay abreast of the latest research and regulatory requirements in order to ensure that their warnings are adequate. Manufacturers who also perform and/or fund state-of-the-art research will be better able to eventually defend the adequacy of their warnings.

Potential Defenses

Company A manufacturers a nanomaterial and sells it in bulk to Company B, which uses the material in producing a widget that is then sold to the public. Can Company A be held liable if the widget allegedly injures a purchaser of Company B’s product? Defendants faced with such liability claims may turn to several related affirmative defenses designed to insulate component manufacturers from liability where their product passes through the hands of intermediaries before reaching the public.

These defenses may relieve manufacturers of any obligation to warn the ultimate consumer of their product in cases where the manufacturers relied on a knowledgeable intermediary to warn the end user. This common-sense approach is recognized, with some variation, in almost all jurisdictions.

Bulk Supplier Doctrine

The bulk supplier doctrine allows a supplier of raw materials to satisfy its duty to warn where the supplier has reasonably relied on an intermediary to transmit warnings to the end user.
It applies in instances where the manufacturer delivers its product, in bulk, to a second company, that may use those raw materials in a variety of ways before packaging the end product for sale.

There are, however, limitations to the applicability of the bulk supplier doctrine. It cannot be invoked when the manufacturer of the raw material voluntarily assist the intermediary in crafting warnings for the end user.

Learned Intermediary Doctrine

The learned intermediary doctrine is often at issue in cases where plaintiffs allege a drug or medical device has injured them. This defense protects manufacturers from liability where the intermediary is “learned” – for instances, a physician – so long as the intermediary has been adequately warned of the product’s risks.

Just what these warnings for prescription mediations and medical devices containing nanomaterials ought to look like very much remains an open question. Under the current regime, the FDA has provided no guidance to nanomaterial manufacturers or pharmaceutical / medical device companies on whether and how to include any information about nanomaterials on labels.

Nanomaterial manufacturers should engage in and maintain their own databases of toxicology studies, clinical trials, and adverse event reports, as well as staying current with the applicable scientific literature to ensure that unreliable science is excluded from the data set used to formulate regulations.

Courts have applied the learned intermediary doctrine even where the drug is still in clinical trial or under investigation by the FDA. This is particularly relevant to manufacturers of nano-products, many of which are currently at an experimental stage.

Sophisticated User Doctrine

The sophisticated user doctrine obviates the need for warning where the intermediary or end-user possesses knowledge “equal” to that of the manufacturer. Just how courts measure “knowledge equal to the manufacturer” varies from jurisdiction to jurisdiction. Some courts apply an objective “knew or should have known” test. Other jurisdictions employ a subjective test, and ask whether the intermediary or end user actually possessed the requisite knowledge.

An intermediary which customarily handles nanomaterials and has developed internal policies for their use might qualify as a sophisticated user.

Conclusion

Because nanomaterials are typically a component part of another product, nanomaterial manufacturers frequently do not sell directly to the end-user or consumer, but rather pass their products through an intermediary who processes, reformulates and/or repackages the nano-product for the market. This significant variation from the typical products liability lawsuit could provide nanomaterial manufacturers with potentially powerful additional defenses against failure-to-warn claims.

Authors Mizgala and Lisak can be contacted at jmizgala@sidley.com and mlisak@sidley.com, respectively, for more information.

Source: BNA Product Safety & Liability Reporter

Nanodermatology Society Releases 2011 Position Statement on the Safety of Nanotechnology in Sunscreens

Fri, 22 Apr 2011 08:20:18 GMT

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."

"For a physician-led group to make available to the public information on why these nano-ingredients are used in sunscreens along with the latest material safety data is extremely important. Nanotechnology, like any new technology, has risks and benefits," explains Dr. Friedman. "Studies of newer sunscreens show that they are either coated to minimize reactivity, clump in aggregates, or do not penetrate the skin. Furthermore, the benefits of sunscreen in reducing the risk of skin cancer including melanoma, which can be deadly, and photodamage are well known."

"As the first of its kind to be released by a scientific society, the position statement will hopefully spur further advances in research in order to maximize the benefits of nanotechnology for the consumer while minimizing its risks," says Dr. Friedman.

The NDS 2011 Position Statement certainly adds something of real value to the ongoing debate about the safety of nano-based sunscreens.

Sources: Nanodermatology Society, Nanotechnology Now.

Potential Human Health Risks of Nanomaterials

Sat, 02 Apr 2011 19:15:34 GMT

"Potential Human Health Risks of Nanomaterials" was published in the March issue of the International Risk Management Institute (IRMI) newsletter.

The article, authored by Gradient Corp.’s Dr. Marc Nascarella and Dr. Barbara Beck, along with Attorney Joseph Clark of Day Pitney LLP, focuses on the potential human health hazards, risks, and liability issues associated with nanomaterial exposure.

The full article is available here, and is excerpted below.

Human Exposure

Nanomaterials are becoming ubiquitous in medicine (e.g., molecular targeted therapies, diagnostic imaging), consumer goods (e.g., cosmetics, electronics, baby products), and building materials (e.g., concrete, steel, windows). However, the potential human health risks following long-term exposure to some products are not certain, as there is generally a lack of exposure data to evaluate if these products are safely performing their intended purpose.

Currently, there are no universally accepted measurement procedures—analytical methods—established for measuring human exposure to nanomaterials precisely. This may be ascribed to the unique physicochemical properties of nanomaterials as compared to bulk materials, such as soil or dust, or volatile chemicals, such as benzene, PAHs, and TCE. The currently employed analytical methods are dynamic, mostly involving a modification of conventional methods for quantifying micro-sized materials.

Human Health Hazards and Risk

Compared to the chemical risk assessment process, where hazards are generally identified as a function of an organism's adverse response to a particular mass of a chemical agent (a dose), characterizing the hazards of nanomaterials has been problematic. This is largely due to the many features that may contribute to the toxicity of nanomaterials.

Currently, there is no consensus within the scientific community on what characteristic may be the most important in elucidating this dose-response relationship for each type of nanomaterial. This lack of agreement is understandable, given that studies evaluating the health effects of nanomaterials show a range of findings (i.e., dose-response relationships) and underscore the inappropriate generalization of responses across all types of nanomaterials.

Government/NGO Recommendations

Most governmental agencies and nongovernmental organizations involved in standardization have been relatively slow in promulgating regulations and standards relating to nanotechnology.

However, in November 2010 the National Institute of Occupational Safety and Health (NIOSH), the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology, issued, for public comment by February 18, 2011, a bulletin addressing exposure to carbon nanotubes in the workplace. Of paramount importance is NIOSH's recommended exposure limit (REL); this represents the first time NIOSH has provided a hard number relating to nanoparticles exposure.

On the environmental front, the U.S. Environmental Protection Agency (EPA) has not only classified certain nanomaterials as "emerging contaminants" but has also issued Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA)7 for single and multi-walled carbon nanotubes.

In addition to government agencies, consensus standards organizations, such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the American National Standards Institute (ANSI) (in conjunction with ISO) are formulating guidelines for the safe handling, use, and disposal of nanomaterials by workers and consumers.

Potential Liability

Whenever there is risk, there is always a potential for liability; in the case of nanotechnology, it is not a case of whether liability will arise, but when.

Recommendations

There are many existing risk management practices that would be prudent to employ based on the current state of knowledge of the potential risks of nanomaterials. Simple good work practices (exposure controls, proper worker education, personal protective equipment, record keeping) are highly advised when manufacturers or industries are working with nanomaterials.

Since the regulatory landscape for this burgeoning new material is dynamic, it is advisable to implement adequate cleanup and disposal protocols when dealing with nanomaterials with uncharacterized hazards. For example, use stringent Food and Drug Administration (FDA) guidance when faced with a material with no existing standards. All risk management practices should be verified and documented using standard health and safety audits (e.g., internal record audits, along with consultant verified records).

Finally, select individuals in each organization ("compliance officers") that are tasked to stay abreast of the developing science and its impact on contemporary workplace practices for your insureds.

About IRMI: International Risk Management Institute, Inc. (IRMI), was founded in 1978 to provide important risk and insurance information to business, legal, risk management, and insurance professionals. In the years since it was founded, IRMI has published a vast and comprehensive library (45,000+ pages) of practical manuals, books, and newsletters. IRMI also sponsors seminars and conferences. To maintain objectivity and avoid conflicts of interest in its research, IRMI does not offer insurance sales, consulting, expert witness, underwriting, or similar services.

Sources: International Risk Management, Inc. online (www.irmi.com) and Gradient Corporation (www.gradientcorp.com)

Nanomaterials Safety along their Life Cycle

Wed, 23 Mar 2011 08:32:58 GMT

SAFETY ISSUES OF NANOMATERIALS ALONG THEIR LIFE CYCLE is a two day Symposium that will be held on May 4-5, 2011, at LEITAT Technological Center, Barcelona (Spain). It is jointly organized by the coordinators of three European Community nanotechnology safety research projects: NANOPOLYTOX, NEPHH and HINAMOX.

The aim of the Symposium is to discuss the human and environmental impacts of nanomaterials along their life cycle from their production through their processing, use, and end of life (recycling and/or disposal). Therefore, the tools and methodologies proposed for the risk assessment (RA) and Life Cycle Assessment (LCA) of nanomaterials will be one of the main topics of discussion in this symposium.

A panel of international experts have been invited as speakers and the lectures will be organized into six different sessions:

Session 1. International, national and regional initiatives on Nanotechnology / Nanosafety
Session 2. Nanomaterials: Synthesis, characterization and applications
Session 3. Human health impact of Nanomaterials
Session 4. Environmental impact of Nanomaterials
Session 5. Risk assessment of Nanomaterials
Session 6. Life cycle assessment of Nanomaterials

The program and registration information can be viewed online at this link:
http://www.leitat.org/nanoLCA/

A brochure with program details, including speakers, is available at:
http://www.leitat.org/nanoLCA/nanoLCA/nanoLCA.pdf

Understanding nanoparticles at large

Wed, 16 Mar 2011 09:06:14 GMT

At the core of research efforts to determine the impact of synthetic nanoparticles on the environment and living systems is a fundamental understanding of the interactions between man-made nanoparticles and natural living systems that have evolved over millions of years.

A March 2011 article in Physical Chemistry Chemical Physics,

"A biophysical perspective of understanding nanoparticles at large"

presents an interesting discussion from a biophysical perspective that describes the fate of nanoparticles in both the aqueous phase and in living systems.

Authors Pu-Chun Ke, Associate Professor of Physics at Clemson University, and Monica H. Lamm, an Associate Professor at Iowa State University, suggest that to better describe nanoparticles at large it is necessary to acknowledge that: 1) the behavior of nanoparticles in biological systems and in the ecosystem are intertwined and often correlated; and 2) collaborations are essential for such interdisciplinary research.

Specifically, the suggested interdisciplinary approach requires:

– the knowledge of material science, chemical engineering, and condensed and soft-condensed matter, which facilitates our understanding of the synthesis and physical properties of engineered nanoparticles;

– the knowledge of organic and biochemistry, which enables our description of the composition, reaction, kinetics, and functionalization of engineered nanoparticles in ambient, aqueous solution, and living systems;

– the knowledge of biophysics and physical chemistry, which underlines the energetics, assembly, and interaction between nanoparticles and solvent molecules, biomolecules, organelles, cells, and organisms, and which are complementary to the information offered by molecular cell biology, microbiology, plant science, toxicology, immunology, physiology, and genetics.

Other fields such as soil science, horticulture, and environmental science and engineering, are also relevant disciplines for examining nanoparticles at large.

Ke's previous work in the nanoscience field is also interesting, for instance in describing the challenge of designing nanomaterials with reduced toxicity or the exploration of nanotechnology's impact on major food crops.

Sources: Nanowerk Nanotechnology Spotlight; Royal Society of Chemistry

Conference - Regulation and Risk Management of Nanotechnology

Fri, 11 Mar 2011 07:54:47 GMT

This conference on Monday, March 21, 2011, in Phoenix, promises to be interesting.

After several years of studying the risks of nanotechnologies, federal agencies such as EPA, FDA and NIOSH are now moving forward with more aggressive regulation, and a variety of other non-regulatory risk management and safety initiatives have been proposed or implemented.

The 2011 conference will examine recent trends and challenges in regulation and risk management of nanotechnology. Top national and international nanotechnology experts from government, industry, non-governmental organizations, the insurance industry, and academia will be featured.

For federal and state regulatory agency perspectives, tentative speakers include:

• Jeff Morris, National Program Director for Nanotechnology, U.S. Environmental Protection Agency (EPA)
• Charles Geraci, Coordinator, Nanotechnology Research Center, National Institute of Occupational Safety & Health (NIOSH)
• Ritu Nalubola, Policy Analyst, U.S. Food and Drug Administration (FDA)
• Jeff Wong, Chief Scientist, California Department of Toxic Substances Control, California Environmental Protection Agency

On the subject of non-regulatory risk management approaches, tentative speakers include:

• EDF-Dupont NanoRisk Framework - Terry Medley, Global Director of Corporate Regulatory Affairs, Dupont
• Responsible NanoCode - Steffi Friedrichs, Director, Nanotechnology Industries Association
• Kristen Kulinowski, Director, International Council on Nanotechnology (ICON) at Rice University

A draft Program of subjects and speakers is available at
http://lsi.law.asu.edu/nanoregulation/docs/nanoregulation_2011_draft3.pdf

For more information visit http://lsi.law.asu.edu/nanoregulation/

* New * : Nano Environmental Health & Safety Podcast

Wed, 09 Mar 2011 08:09:12 GMT

The American Society of Mechanical Engineers (ASME) Nanotechnology Institute has published a new podcast as part of its educational outreach initiative on all aspects of nanotechnology developed by society.

The podcast, "Nano Environmental Health & Safety", with Dr. Andrew Maynard, Chair of the University of Michigan Risk Science Center, deals with environmental, health and safety aspects of nanotechnology.

Maynard, of course, is one of the most prolific nanorisk speakers and writers, and this latest ASME-sponsored discussion is worthwhile.

The podcast is available via download on a complimentary basis at http://nano.asme.org/, where you can also sign up to be added to the Nanotechnology Institute mailing list to get announcements and information on ASME's Nanotechnology Institute endeavors.

Source: ASME Nanotechnology Institute

Bridging US and EU NanoEHS Research Efforts in 2011

Mon, 21 Feb 2011 08:24:28 GMT

A joint workshop between the United States and the European Union will be held from March 10-11, 2011 in Washington, DC, in an effort to promote more effective collaboration between the two entities.

The purpose of the workshop, "The US and EU: Bridging NanoEHS Research Efforts", is to: Engage in an active discussion about Environmental Health and Safety questions for nano-enabled products; Encourage joint programs of work that would leverage resources; and, Establish communities of practice, including identification of key points of contact/interest groups/themes between key U.S. and EU researchers and key U.S. and EU funding sources for near-term and future collaborations.

Sponsors include the U.S. National Nanotechnology Initiative (NNI), the European Commission, the American Association for the Advancement of Science, and the U.S. Environmental Protection Agency.

The full program can be viewed online at the link below.
http://www.nano.gov/html/meetings/us-eu/index.html

Source:National Nanotechnology Initiative

Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims - PART 2

Sun, 21 Nov 2010 10:52:38 GMT

In an article published in the November 11, 2010, issue of Toxics Law Reporter -- Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims --I discuss the prospect of nanoparticle mass tort/class action litigation, the likely claims and defenses, and offer a preview of potential Daubert-style challenges to exposure, dose, and causation experts given the state of science and the law in late 2010.

In a two-part blog article, I have excerpted and condensed that article. In Part 1, on November 14, I discussed the likely mass tort/class action claims. In Part 2 below I discuss the tactics for defeating early mass nanotort claims.

* * * *

Tactics for Defeating Early Mass Nanotort Claims

For most nanomaterials, there is not yet a comprehensive understanding of their toxicological properties, how they can enter the human body, how the body might react to them, their interactions with other materials in the environment, or how they might age in the body or in the environment. The sophisticated toxic tort/mass tort bar understands that the current high level of scientific uncertainty about nanoparticle risk makes it near-impossible to meet the burden of proof of causation – general and specific – recognized in both federal and state courts in the context of toxic exposure personal injury and wrongful death claims. The science needed to assess hazards of nanomaterials in the fields of toxicology, epidemiology, and industrial hygiene, let alone meeting the standards for admissibility of such scientific evidence under Daubert, is likely to be many years in the making.

Product Identification and Substantial Factor Proof Hurdles

The legal principles and defenses developed in the context of other toxic exposure litigation, e.g., asbestos and benzene, should apply with equal force in the context of nanoparticle exposure claims – requiring product identification, proof of substantial factor in causation, etc. In this regard, nanomaterial detection is a significant practical obstacle to claims. Due to their size and ‘‘invisibility’’ except using sophisticated and expen-mere detection of nanomaterials remains difficult. Thus, it is unclear how any examining physician could even identify the presence of any nanoparticles, much less then reliably attribute a health problem to a particular nanomaterial.

In many jurisdictions, the absence of an as-yet undiscovered signature disease connected to nanoparticle exposure means that the substantial factor doctrine will apply, as it does in cases where plaintiff’s injury could have resulted from multiple exposures or underlying conditions. Under the substantial factor test, a ‘‘[d]efendant’s conduct in an action for personal injuries is considered a cause of the event if it was a material and substantial factor in bringing it about.’’ The necessity of plaintiff providing admissible (Daubert-proof) expert testimony concerning differential etiology in order to meet the substantial factor requirement is an extremely high hurdle given the relatively nascent state of nanotoxicity science now in 2010 and for the foreseeable future.

Even supposing that a claimant could succeed in proving exposure to a particular type of nanoparticle, and that such exposure was a causative substantial factor in connection with an injury, the problem then is traceability to a specific defendant. Nanoparticle product identification is a major practical obstacle. Current technology does not allow uniquely identifying nanomaterials with reliability. With the number of nanomaterials under research and in production multiplying rapidly each year, it is virtually impossible to trace a particular offending nanomaterial back to its manufacturer. The lack of reliable traceability is normally a significant impediment to tort litigation, although the use of legal concepts like alternative liability and marketshare liability will likely be argued in the nanoparticle context when certain nanomaterials are commoditized and the law searches for a basis to attach liability.

In light of the novel nature of the science underlying potential nanotechnology-related claims, and the difficulty of product and defendant identification, there are several powerful weapons that defendants should be developing to use from the outset of any nanoparticle mass tort claims.

"Lone Pine" Orders

One approach is the use of a so-called "Lone Pine" order in jurisdictions where that is viable. The term is derived from Lore v. Lone Pine Corp., a toxic exposure case where, shortly after the case was filed, the court required the plaintiffs’ counsel to detail the facts of each plaintiff’s claims, including exposure to alleged toxic substances and reports of treating physicians and medical or other experts supporting causation. The order was designed to require plaintiffs to make an objective showing – early in the litigation – that there was sufficient evidentiary basis to warrant continued litigation The Lone Pine order has been widely accepted andused in federal and state courts throughout the nation.

"Twiqbal" Motions to Dismiss

Defendants in any mass nanotort litigation will also likely pursue so-called "Twiqbal" motions to dismiss at the initial pleadings stage. Under the Iqbal/Twombley plausibility standard, it would seem that federal courts should require toxic tort plaintiffs to present scientifically plausible bases for their claims at the outset in initial complaints.

Daubert Gatekeeping at Class Certification Stage

Until recently, many federal judges had held that they must not evaluate the admissibility of scientific evidence in ruling on motions for class certification, because that ‘‘gatekeeping’’ function somehow overlaps with ‘‘merits’’ issues to be decided later in the case by the factfinder. But the tide has turned. The past few years have seen a line of emerging authority clarifying and expanding on the ‘‘rigorous analysis’’ district courts must apply to each class-certification factor under Rule 23. A district court must resolve factual disputes relevant to each class action prong, including those disputes inter-twined with the merits.

That means a rigorous analysis, at the early class certification stage, of the factual bases of plaintiffs’ nanoparticle exposure claims. And that means a Daubert-style analysis of plaintiffs’ proposed exposure, dose, and causation expert opinions. Indeed, recent federal courts of appeal have held that ‘weighing conflicting expert testimony at the certification stage is not only permissible, it is integral to the rigorous analysis Rule 23 demands. There is now a clear and strong trend in the federal courts requiring close scrutiny of expert testimony at the certification stage in federal class actions to make certain that class certification decisions are based only on evidence that is admissible under the Federal Rules of Evidence and Daubert. That should present an almost insurmountable obstacle for any early nanoparticle class action claims, given the dearth of science that plaintiffs would need to meet their difficult burdens.

The federal trend is being followed at the state level, where a number of state courts have also opined during the past two years that rigorous analyses of facts at the class certification stage should include resolution of fact disputes regarding the propriety of certification, including evaluating the weight of expert opinions and resolving relevant expert disputes.

Conclusion

In the absence of legislative or regulatory action not yet contemplated, the revolutionary changes expected to be brought about by nanotechnology will play out within the established framework of American tort liability law that has accommodated and addressed every emerging technology of the past. Mass tort and class-action toxic exposure lawyers have important roles to play in determining the degree to which the fantastic economic and societal benefits of nanotechnologies are realized.

Carbon Nanotube Toxicity: New study examines effects on plant cells

Tue, 16 Nov 2010 17:39:35 GMT

Single-walled carbon nanotubes (SWCNTs) have many unique structural and mechanical properties. As a result, their potential applications -- especially in materials science and mechanical engineering, biomedical engineering and medical chemistry -- have been increasing. Results of studies in animals have raised concerns about the potential toxicity of some shapes and sizes of carbon nanotubes but the toxicological impact of nanoparticles has rarely been studied in plants.

Recent research by a team of scientists from China, led by Dr. Nan Yao, explored the effects of nanoparticles on plant cells. Their assessment of SWCNT cytotoxicity is published in the October 2010 issue of the American Journal of Botany.

Dr. Yao and his team of researchers isolated cells from rice as well as from the model plant species Arabidopsis. The researchers treated these cells with carbon nanotubes, and then assessed the cells for viability, damage to DNA, and the presence of reactive oxygen species.

The researchers found an increase in levels of the reactive oxygen species hydrogen peroxide. Reactive oxygen species cause oxidative stress to cells, and this stress can result in programmed cell death. Dr. Yao and his colleagues discovered that the effect of carbon nanotubes on cells was dosage dependent — the greater the dose, the greater the likelihood of cell death. In contrast, cells exposed to carbon particles that were not nanotubes did not suffer any ill effects, demonstrating that the size of the nanotubes is a factor in their toxicity.
“Nanotechnology has a large scope of potential applications in the agriculture industry, however, the impact of nanoparticles have rarely been studied in plants,” Dr. Yao said. “We found that nanomaterials could induce programmed cell death in plant cells.”

Despite the scientists’ observations that carbon nanotubes had toxic effects on plant cells, the use of nanotechnology in the agriculture industry still has great promise. The scientists only observed programmed cell death as a temporary response following the injection of the nanotubes and did not observe further changes a day-and-a-half after the nanotube treatments. Also, the researchers did not observe death at the tissue level, which indicates that injecting cells with carbon nanotubes caused only limited injury.

“The current study has provided evidence that certain carbon nanoparticles are not 100% safe and have side effects on plants, suggesting that potential risks of nanotoxicity on plants need to be assessed,” Dr. Yao stated. In the future, Dr. Yao and colleagues are interested in investigating whether other types of nanoparticles may also have toxic effects on plant cells. “We would like to create a predictive toxicology model to track nanoparticles.”

And so this add to the knowledge base concerning potential toxicity of SWCNTs.

CITATION: Cong-Xiang Shen, Quan-Fang Zhang, Jian Li, Fang-Cheng Bi, and Nan Yao (2010). Induction of programmed cell death in Arabidopsis and rice by single-wall carbon nanotubes. American Journal of Botany 97(10): 1602-1609. DOI: 10.3732/ajb.1000073

Source: Botanical Society of America Inc.

Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims - PART 1

Sun, 14 Nov 2010 13:11:35 GMT

The existence of a large, well-financed mass tort infrastructure makes it likely that plaintiffs’ attorneys will try to exploit the Age of Nanotechnology through mass tort and class actions. Plaintiffs who already have a disease will assert that their diseases were caused by or exacerbated by their exposures to anoparticles. Those without disease will assert a need for medical monitoring.

In a two-part blog article, I have excerpted and condensed the article. Here is Part 1.

* * * *

Is Mass Nanotort and Class Action Litigation Drawing Nigh?

‘‘The Rise of Nanotech Litigation.’’ So reads the cover of the Winter 2010 issue of Litigation News, the magazine of the ABA Section of Litigation.

‘‘Nanotechnology: Brave New World for Civil Tort Plaintiffs.’’ So reads the title of a recent article in The SciTech Lawyer, the magazine of the ABA Section of Science & Technology Law.

It is not just lawyers who foresee a potential flood of new tort claims.
– ‘‘EU Ministers Call for Nanomaterial Ban,’’ Chemistry World, June 2010
– ‘‘Nanosilver has No Place in Food, Textiles, or Cosmetics,’’ German Federal Institute for Risk Assessment, June 2010.
– ‘‘A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.’’ AOL News Special Report series, The Nanotech Gamble: Bold Science, Big Money, Growing Risks, March 2010
– ‘‘Nanoparticles – one word: A multiplicity of different hazards,’’ Nanotoxicology, December 2009
– ‘‘Nanotechnology could possibly translate into mega risks.’’ Tiny Objects, Big Concerns: Managing Nanotechnology Risks, Claims Magazine, December 2009

How Concerned Should We Be?

Although only tentative, some early studies suggest that some specific nanoparticles already in widespread use may have health and environmental consequences.

For instance, certain carbon nanotubes (CNTs) – the most commonly used nanomaterial in industrial applications – resemble asbestos fibers in some respects and some researchers have reported that CNTs, injected into mice, caused the type of lesions and inflammation that develop from asbestos exposure.

Some early studies have suggested that nano-titanium dioxide (TiO2) – a commonly used nanomaterial in consumer products today – can damage or destroy DNA and chromosomes, potentially leading to cancer, heart disease and brain injury.

And research concerning nano-silver (Au) – currently used in more consumer products than any other nano-material – has found probable ecotoxicity and biotoxicity for aquatic and plant species in the food chain.

Not If, but When, the Claims Will Be Made

As nanotechnology has proliferated, many interest groups and even governmental entities have sounded alarms about the potential risks it poses. These groups have already accused the industry of failing to do due care testing and failing to ensure the safety of those who may become exposed to engineered nanomaterials. Experience teaches that when there are concerns about possible health and safety hazards, litigation – feeding upon public and political risk perception – is never far behind.

Vast amounts of ‘‘nanorisk’’ information is available on the Internet, creating a network of information for potential plaintiffs and their counsel. Despite the uncertainties of health and environmental hazards, nanotorts are a virtual certainty. Why? Because a large, well-financed mass tort infrastructure is in place. The question is not so much if, but when, nanotort claims and litigation will arise.

Traditional Toxic Exposure Class Action Claims

Over the past 30 years, the clear trend has been to deny certification of classes in actions alleging toxic torts, including those seeking classwide medical monitoring, because the individual issues have predominated over the common issues. Establishing that common issues of fact and law predominate over individual issues of fact and law will be near impossible for nanomaterial exposure claims because the highly individualized issues of exposure, dose-response, medical history, causation (including the requirement that courts examine alternate causes on an individualized basis), and damages will predominate.

Despite the difficulty of class action certification in the toxic tort area, plaintiffs have had some pockets of success that may apply to the nanotechnology context. For example, class certification may be achieved if an action can successfully be divided into phases that allow for class-based litigation of some issues involving issues of common proof (e.g., negligence, whether product was unreasonably dangerous, failure to warn, entitlement to punitive damages), while providing for determination of individual liability and compensatory damages in separate phases.

Class certification has also recently been affirmed in the context of medical monitoring laims, in those jurisdictions recognizing such claims in the absence of a present physical injury. In such cases, because individual class members need not prove an actual injury, the courts have been more inclined to find that the key issues are matters of common proof. These are narrow exceptions to the trend against class certification in cases alleging personal injury or some adverse health impact.

Medical Monitoring Claims

Medical monitoring claims represent an area of possible early nanoparticle exposure mass tort/class action activity, because they have the potential in some jurisdictions to avoid some of the stringent individualized exposure and causation problems described above. Medical monitoring claims – recognized in some, but not all, jurisdictions – are further divided into two types: jurisdictions requiring present physical harm and those with no present physical harm requirement.

For those jurisdictions with a present physical injury requirement, the burdens described above for nanoexposure claims are essentially the same, making it very difficult for plaintiffs to succeed in exposure cases. Nanoparticle class action plaintiffs will attempt to overcome or sidestep some of the current hurdles by making novel arguments about what constitutes a ‘‘physical injury’’ where there has been nanomaterial exposure. Nanotort claimants will argue that exposure to a hazardous substance has indeed caused them such an injury, in the form of cellular and sub-cellular changes that occur when the molecules of the hazardous substance entered their body. Arguments will be made that exposure to novel man-made nanomaterials requires fashioning of new law based on the unique biological issues presented by nanomaterials that have no precise legal analog.

Existing case law appears to erect an effective defense for nanomaterial product manufacturers whose products contain particles arguably capable of causing cellular or sub-cellular level changes. I n states that have considered the issue thus far - in the context of exposure to substances such as beryllium, cesium, and uranium - plaintiffs have een required to prove the existence of a patent physical injury to successfully bring a cause of action. Asymptomatic cellular or sub-cellular changes have not been compensable - yet.

If claimant class counsel pursuing a nanoparticle case cannot base ‘‘injury’’ claims on subclinical, cellular, and/or subcellular changes without any diagnosed disease process, where will they go next? Nanoparticle exposure is almost certain to be a target of practitioners in fields such as ‘‘environmental medicine’’ and so-called ‘‘complementary and alternative medicine.’’ Many of those practitioners staunchly advance an agenda that exposures to many common substances are toxic, and various nonspecific ailments and negative health conditions are caused by exposures, such as multiple chemical sensitivity, chronic fatigue syndrome, attention deficit disorder, muscle and joint pain, cardiovascular disease, hormone imbalance, and a variety of other syndromes and ‘‘ailments of unknown etiology.’’

In sum, existing case law is certainly helpful to potential nanomaterial-producing defendants and erects difficult barriers to a successful nanoparticle-based toxic exposure class action claim. But the law is certainly not static. The advent of tort litigation concerning nanomaterials that have no precedential risk assessment in science or the law creates the opportunity for claimant attorneys to press for new ways of assessing what constitutes ‘‘injury,’’ harm, and relevant risk.

‘No Injury’ Consumer Class Action Claims

Another probable form of nanotort litigation is pursuit of so-called ‘‘no injury’’ or ‘‘fraud light’’ claims. Pursued primarily as class actions, these cases have sprung up in the past decade in direct response to the increasing difficulty with proving personal injury in the mass tort and exposure context and the problems of obtaining class certification.

Typically brought pursuant to state consumer protection statutes, these claims do not allege any personal injury at all; rather, they seek only economic damages in the form of a refund of the product purchase price. Seeking only an economic remedy avoids almost all of the difficult causation issues.

The nanotechnology industry can learn from recent ‘‘lead in lipstick’’ litigation. The litigation was precipitated by an October 2007 special-interest group (Campaign for Safe Cosmetics (CFS)) ‘‘study’’ claiming that certain lipsticks contained dangerous amounts of lead and posed a danger to consumers. Within a few months class action plaintiffs’ counsel had filed suits against lipstick manufacturers parroting the CFS’s claims. Plaintiffs argued that they would not have purchased the lipstick had they known of its lead content and pursued causes of action like breach of implied warranty, unjust enrichment, and statutory consumer fraud. They sought narrow economic damages, including the return of the purchase price and the costs of diagnostic testing and medical monitoring. Although the individual claims were small, once aggregated they represented very significant liability.

The lesson for nanotechnology? First, the highly competitive plaintiffs’ class action bar is always ready to pounce on a perceived opportunity and multiple class-action lawsuits can quickly spring up across the country after the publication of a nonconclusive, but headline-catching, study or report. Second, there are already many Internet-available special interest group ‘‘studies’’ and ‘‘reports’’ targeting nanomaterials for their alleged environmental, health, and safety dangers. Many could easily form a cut-and-paste basis for a ‘‘no injury’’ class action lawsuit. Manufacturers utilizing nanotechnology should prepare for such actions.

For example, such a claim may be made on behalf of all purchasers of an existing nanoconsumer product – such as a cosmetic or sunscreen using nano-titanium dioxide or nano-zinc oxide particles – claiming that the manufacturer failed to label the product as containing nanoparticles, failed to warn about possible adverse latent health risks of nanoparticles, and thus misrepresented the risk of injury from use of the product. Some courts may allow such a claim to proceed if claimants’ attorney is armed with an expert witness and a study or two that suggests an increased risk from exposure to relevant nanoparticles – including those that may be prepared more or less specifically to support litigation. The economic risk to the defendant manufacturer of potentially refunding the purchase price for thousands or tens of thousands of claimants may be unacceptable high, depending on the parameters of the scenario, and a large class settlement may be extracted.

* * * *

In Part 2, I will discuss the tactics for defeating early mass nanotort claims.

Nanomedicine – Amazing Benefits Tempered by Unknown Risks

Mon, 08 Nov 2010 18:35:02 GMT

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.

Oberdorster pointed out that many studies that are being done to evaluate nanomaterials, but most are using extremely high doses of the material, which calls their relevance into question. Risk, he reminded the audience, is a combination of the hazard posed by a material and the amount of exposure. “If a particle is low hazard, it doesn’t matter what the exposure is. It will still be low-risk,” Oberdorster said. And the converse is also true.

Howard said his agency’s biggest problem is the difficulty of detecting problematic materials, since many traditional testing methods are inconsistent or completely unreliable when nanomaterials are involved. That’s caused some hesitancy in the regulatory field, as researchers struggle to find a standardized test in order to set benchmarks for drug developers.

There have been successes, he said. For example, FDA researchers found that nano-sized titanium dioxide particles used in sunscreens didn’t penetrate much beyond the surface of the skin of pigs used in the testing. Fear of the nanoparticles accumulating inside the human body has been a top criticism of nano sunscreens, and there is still much to learn. On this subject, see my posts:

1. Zinc Oxide Nanoparticles - Recent Studies Raise More Questions about Safety

2. Are Nanoparticles in Sunscreens Safe? Friends of the Earth says "Nano should be a no-no"

Many medical researchers working in the nano field tout the biodegradable nature of their materials, but Oberdorster said it’s important to know what happens to nanoparticles when they break down, accumulate in the body, or otherwise change. Scientists also need to find out what happens to the materials after they come out of the body, and if they could accumulate in wastewater like traces of prescription drugs. "The question I would ask is, where does it go? How is it metabolized?" Oberdorster said. "That's the key issue, to follow the life cycle of a nanomaterial, from cradle to grave."

Both researchers concurred that a lot more investigation is needed to understand what's dangerous, and what's not, when it comes to nanomedicine.

I have written on this subject if you are interested in reading more:

Nanomedicine Risks and Benefits – Part 1

Nanomedicine Risks and Benefits – Part 2

Nanotechnology in Medical Applications: Hippocratic Oath and Hegelian Recursion

Sources: Meridian Nanotechnology and Development News, New Haven Independent

Zinc Oxide Nanoparticles - Recent Studies Raise More Questions About Safety

Fri, 05 Nov 2010 16:50:47 GMT

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.

1. Research Suggests that Zinc Oxide Nanoparticles are Bioavailable and Toxic after Dietary Exposures

Research conducted by the United States Geological Survey, the John Muir Institute of the Environment, University of California, both in the U.S., and the Natural History Museum, United Kingdom, found that zinc oxide (ZnO) nanoparticles were bioavailable and toxic after dietary exposure. The research was predicated on the theory that if engineered nanomaterials are released into the environment, some are likely to end up as food of animals due to aggregation and absorption processes. The team was able to show that zinc from isotopically modified ZnO particles is efficiently assimilated by freshwater snails when ingested with food. The ZnO nanoparticles were found to damage digestion of the snails - they ate less, defecated less, and inefficiently processed the ingested food - due to the exposure to high concentrations of ZnO. The team was unable to determine whether the toxicity was due to the high Zn dose achieved with nanoparticles or to the ZnO nanoparticles themselves, but concluded that "[F]urther study of exposure from nanoparticles in food would greatly benefit assessment of ecological and human health risks."

2. Research Suggests that Zinc Oxide Particles in Sunscreens Applied Outdoors Are Absorbed through Human Skin

Although some previous research has concluded that topically applied nanoparticles do not penetrate healthy skin, it remains contentious whether this conclusion holds under normal conditions of sunscreen use. Recent research conducted by a group of Australian scientists, and published in the November 2010 issue of Toxicological Sciences, provided some additonal data on that question. Humans (n = 20) were exposed to sunscreens containing zinc oxide (ZnO) particles to determine if Zn from the particles was absorbed through skin over five consecutive days under outdoor conditions. Two sunscreens were tested—“nano sunscreen” containing 19-nm nanoparticles and “bulk sunscreen” containing > 100-nm particles. Venous blood and urine samples were collected 8 days before exposure, twice daily during the trial, and 6 days post-exposure. The overwhelming majority of applied Zn was not absorbed, although blood and urine samples from all subjects exhibited small increases in levels of tracer Zn. Tracer levels in blood continued to increase beyond the 5-day application phase in contrast to those in urine. Interestingly, levels of Zn in blood and urine from females receiving the nano sunscreen appeared to be higher than males receiving the same treatment and higher than all subjects receiving the bulk sunscreen.

3. Research Suggests that Long-Term Exposure to ZnO and TiO2 Nanoparticles has Advserse Effects on Skin Cells

Researchers at the University of Ljubljana, Slovenia, reported in the September 6, 2010, issue of the journal Small, that long-term exposure to zinc oxide (ZnO) and titanium dioxide (TiO2) nanoparticles has adverse effects on human keratinocytes – the primary cell type found in the epidermis – in vitro, indicating that these nanoparticles are a potential health risk. Sunscreens containing ZnO and TiO2 nanoparticles (NPs) are increasingly being applied to skin over long time periods to reduce the risk of skin cancer, but long-term toxicological studies of those NPs are sparse. The team of researchers studied the intracellular formation of radicals, alterations in cell morphology, mitochondrial activity, and cell-cycle distribution of ZnO and TiO2 NPs over short- and long-term applications. Zinc oxide NPs were found to have more pronounced adverse effects on keratinocytes than titanium dioxide NPs.

The new research certainly does not support the danger conclusions advanced by Friends of the Earth, but it does suggest that there is a basis for much more research into the potential ecological and human health risks of metal oxide nanoparticles like ZnO.

Sources: Informa Health Care, Toxicological Sciences, Small

New Daubert Blog : Highly Recommended Resource

Mon, 01 Nov 2010 17:13:18 GMT

I recommend that you add to your "links" or "favorites" for regular consultation a new blog on on the Daubert standard, "Daubert Uncensored." The Daubert Uncensored blog is a free resource offering a unique and in-depth perspective that provides the claims industry and in-house counsel with up-to-date news and commentary on important Daubert cases and evolving trends across the country.

The lead writer of Daubert Uncensored is John Sear, a Partner in the Minneapolis office of the national product liability defense firm Bowman and Brooke. Sear has unique gravitas to command respect on this subject, having successfully tried or litigated a wide variety of cases involving medical devices and institutional chemical products. Sear has briefed and argued Daubert motions in such far-ranging fields as orthopedics, chemistry, human factors, obstetrics, mechanical engineering, toxicology, epidemiology, biostatistics, immunology, and veterinary medicine, and defended his favorable rulings on appeal. He frequently lectures and publishes on civil litigation practice and procedure, with an emphasis on Daubert and summary judgment issues. Now we can all benefit from his experience and commentary - at no cost!

Daubert Uncensored promises to highlight significant Daubert cases and provide insight on critical information such as who was challenged, the corresponding disciplines and areas of expertise, and whether or not testimony was admitted or excluded. According to Sear, “it is vital for those involved to know every facet of how best to approach the Daubert process. That is the goal of the Daubert Uncensored blog – to peel away the layers of some of the more complex Daubert cases and provide a fresh look at what tactics are most effective in today’s legal landscape.”

With the permission of the Daubert Uncensored Blog I have below reproduced one of its recent posts, a discussion about the important Daubert factor dealing with whether an expert's proposed opinion has been subject to peer review and publication, or whether it is simply "made for litigation."

Peer Review and Publication: A Powerful Weapon in the Daubert Arsenal

October 19, 2010 | Posted by John Sear

Daubert recognizes that peer review and publication are factors courts may consider in determining the reliability and, hence, admissibility, of expert testimony:

Another pertinent consideration is whether the theory or technique has been subjected to peer review and publication. Publication (which is but one element of peer review) is not a sine qua non of admissibility; it does not necessarily correlate with reliability, and in some instances well-grounded but innovative theories will not have been published. Some propositions, moreover, are too particular, too new, or of too limited interest to be published. But submission to the scrutiny of the scientific community is a component of “good science,” in part because it increases the likelihood that substantive flaws in methodology will be detected. The fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.

But how do these considerations affect the admissibility analysis? Significantly. Experts testifying in large-scale litigation are usually leaders in their field—when the outcome depends upon compelling expert testimony, parties ordinarily retain first-string experts. Challenging the experts’ qualifications will almost always be futile, so focusing on peer review and publication will strengthen any challenge to the testimony.

Ask what literature the expert HAS published.

Scientific literature published by the experts themselves will illuminate their opinions and methodologies and offer powerful ammunition for a successful Daubert attack. “The ultimate test of a scientific expert’s integrity is her readiness to publish and be damned.” Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1318 (9th Cir. 1995) (quoting Peter W. Huber, GALILEO’S REVENGE: JUNK SCIENCE IN THE COURTROOM at 209 (1991)). When experts publish opinions in peer-reviewed journals, they must adhere to rigorous standards of scientific integrity that prohibit sweeping, scientifically unfounded conclusions—their litigation opinions should be held to the same standards. E.g., Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999) (holding that Rule 702 imposes a gatekeeping duty “to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practices of an expert in the relevant field”). For example, in Kilpatrick v. Breg, Inc. (discussed elsewhere on this blog), the plaintiff’s expert was an editor of a leading peer-reviewed journal in the field of orthopedics. In an editorial in that journal, he cautioned readers that “further research is required to determine the cause, and proper prevention, of shoulder chondrolysis,” an orthopedic condition affecting articular cartilage of joints following arthroscopic surgery. When the expert donned his litigation hat, however, he professed to know to a reasonable degree of medical probability that intra-articular use of the defendant’s infusion pump could and in fact did cause Plaintiff’s chondrolysis and that “[t]here is no other, reasonable explanation or potential cause in this case.” The district court excluded the expert’s testimony, and the Eleventh Circuit affirmed that ruling.

Daubert does not condone such inexplicable flip-flopping by expert witnesses, as the Middle District of Florida recently explained:

At the Daubert hearing, Dr. Tulloch characterized this remarkable evolution in his opinions as mere “fine-tun[ing]” and asserted that his most recent opinions were “pretty well similar.” This is simply wishful thinking on Dr. Tulloch’s part; such characterizations grossly understate the significant changes associated with his expert opinions over the course of this case. This is not the relatively unremarkable situation where an expert witness merely tweaks an opinion in response to new considerations. At the very least, the drastic changes in Dr. Tulloch’s opinions illustrate that he reached his initial conclusions prematurely and based on incomplete data, then later gathered what additional information he could to shore up his initial opinions. This approach smacks of post-hoc rationalization and is devoid of the intellectual rigor that Daubert demands. Put bluntly, this is not how good science is done.

Haller v. AstraZeneca Pharm. LP, 598 F.Supp.2d 1271, 1296-97 (M.D. Fla. 2009). See generally Kumho Tire, 526 U.S. at 152 (holding that Daubert standards are intended “to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field”).

Ask what literature the expert has NOT published.

Expert witnesses are quick to spew litigation opinions as clear, compelling, beyond doubt, and a no-brainer, when they would never dare to submit those same opinions to the scrutiny of their peers. The experts’ unwillingness to subject opinions to peer review and publication speaks volumes about the scientific reliability of the analyses and conclusions.

In mass tort litigation, often “the only review the plaintiffs’ experts’ work has received has been by judges . . ., and the only place their theories and studies have been published is in the pages of federal . . . reporters.” Id. Despite the length of time the pain pump controversy has brewed, none of Plaintiffs’ experts have deemed their causation conclusion “worthy of verification, refutation or even comment.” While the attorneys offering the experts’ testimony, of course, wholeheartedly endorse their experts opinions, “examination of a scientific study by a cadre of lawyers is not the same as its examination by others trained in the field of science or medicine.” Id. (quoting Perry v. United States, 755 F.2d 888, 892 (11th Cir. 1985)). The experts’ unwillingness or inability to publish their theories suggests “a tacit understanding within the scientific community that what’s going on here is not science at all, but litigation.” Id.

After all, if anyone could be expected to publish about the issue at the center of mass tort litigation, it is the first-string experts named by the parties, many of whom profess to be leaders in their respective fields and many of whom already have published extensively. Often, the experts on both sides of the “v.” have published on multiple occasions in papers, books, and articles, and rarely shy away from the peer review and publication process. Their failure or refusal to publish the theories they espouse compels the conclusion that the theories do not meet even the minimal criteria of good science:

None of the plaintiffs’ experts has published his work on Bendectin in a scientific journal or solicited formal review by his colleagues. Despite the many years the controversy has been brewing, no one in the scientific community—except defendant’s experts—has deemed these studies worthy of verification, refutation or even comment. It’s as if there were a tacit understanding within the scientific community that what’s going on here is not science at all, but litigation.

* * *

There may well be good reasons why a scientific study has not been published. For example, it may be too recent or of insufficiently broad interest. These reasons do not apply here. Except with respect to the views expressed in this litigation, plaintiffs’ experts have been well-published, and the opinions they proffer, if supported by sound methodology, would doubtless be greedily devoured by the machinery of peer review. A conclusion that Bendectin causes birth defects would be of significant public interest both in this country (where millions of women have taken Bendectin and the FDA continues to approve its use) and abroad (where Bendectin is still widely used). That plaintiffs’ experts have been unable or unwilling to publish their work undermines plaintiffs’ claim that the findings these experts proffer are ‘ground[ed] in the methods and procedures of science’ and ‘derived by the scientific method.’

Daubert, 43 F.3d at 1318, 1318 n.9 (quotations and citations omitted).

Clearly, the “peer review and publication” factor has teeth, and can significantly and powerfully buttress any challenge to testimony under Daubert. The factor affects admissibility both when the expert has published on the subject of their testimony and, often more so, when they have not.

Visit www.daubertuncensored.com for more information and to keep abreast of new case law and other key developments that will be of great interest to all of us on the defense side in the emerging field of Nanotechnology litigation.

Nanoparticles in consumer products “a game of health and safety roulette” according to EU Consumers Organizations

Thu, 28 Oct 2010 07:15:52 GMT

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.

Health and Safety Roulette?
"In the absence of independent safety assessment, and given the unconfirmed nature of the claims, we believe action needs to be taken urgently," according to Stephen Russell, ANEC Secretary-General. "Legislation relevant to nanotechnologies must be adapted to safeguard consumer health and safety. Public awareness must be raised through the creation of a public inventory where it would be mandatory for manufacturers to register products on the European market claiming to contain nanomaterials. We also want to see a legal requirement introduced for the labelling of some nano-products."

Monique Goyens, BEUC Director-General, added: "Our inventory shows that hundreds of products are on sale today to European consumers without assessment of their claims or the risks these nanomaterials may pose to public health. This game of health and safety roulette must end. That is why we support the Belgian Presidency's initiative on mandatory traceability of nanomaterials and presented our inventory to the European Commissioner for Health & Consumer Policy, John Dalli."

The Belgian initiative Goyens references was the subject of my September 17, 2010 post, “EU Nano-Regulation: Specific Nanomaterial register under REACH and Mandatory Labeling for Consumer Products.”

The new press release and accompanying consumer product inventory and commentary are consistent with the BEUC/ANEC cautionary position on nanotechnology published in November 2009, entitled “Nanotechnology: Small is beautiful but is it safe?”

The BEUC and ANEC
The BEUC (Bureau Européen des Unions de Consommateurs), aka the European Consumers’ Organization, has a membership of 43 independent national consumer organizations from 31 European countries (EU, EEA and applicant countries). BEUC acts as the umbrella group in Brussels for those groups and its primary self-described function is to represent its members “and defend the interests of all Europe’s consumers.”

ANEC is a sister organization to the BEUC. Self-described as “the European consumer voice in standardization,” ANEC represents consumers from EU Member States and 3 EFTA countries (Iceland, Norway and Switzerland) in the creation of technical standards, especially those developed to support the implementation of European laws and public policies. ANEC participates principally through its voluntary experts in the standards development work of the three European Standards Organizations (ESOs) recognized by the European Union and EFTA.

Sources: Nanowerk News and The European Consumers' Organisation (BEUC)

Risk uncertainty leads to Australia’s new nanomaterial regulations, effective January 1, 2011

Wed, 20 Oct 2010 09:14:13 GMT

The accelerating trend of nanomaterial government regulation continues, this time in Australia. These are significant because Australia is the world's 13th largest economy and a major export destination for the products of United States manufacturing companies.

The new regulatory processes, enacted under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), will take effect on January 1, 2011, and will apply to any new material/chemical that falls under the following working definition of an "industrial nanomaterial":

...industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)"

Notes to the working definition:

 “intentionally produced, manufactured or engineered” materials are distinct from accidentally produced materials

 “unique properties” refers to chemical and/or physical properties that are different because of its nanoscale features as compared to the same material without nanoscale features, and result in unique phenomena (e.g. increased strength, chemical reactivity or conductivity) that enable novel applications.

 aggregates and agglomerates are considered to be nanostructured substances

 where size distribution shows 10% or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.

Any substances meeting the definition will require a NICNAS permit or certificate if introduction is to continue after that date. The new administrative regulations are available here: http://www.nicnas.gov.au/Publications/Chemical_Gazette/pdf/2010oct_whole.pdf#page=14

Stated Reasons for the New Nanomaterial Regulations: Environmental, Health and Safety Risk

These administrative amendments to the new chemicals notification and assessment framework are components of the NICNAS strategy for regulating industrial nanomaterials. According to the Australian government, these are necessary to "address the uncertainty surrounding the risks posed by industrial nanomaterials and the appropriateness of current risk assessment protocols and practices." These regulations also are needed "to maintain or enhance existing levels of public health, worker safety and environmental protection in relation to industrial nanomaterials."

The new regulations have been developed in consultation with the NICNAS Nanotechnology Advisory Group, comprising industry, community, government and scientific experts.

Changes to the new chemicals framework for nanomaterials included in NICNAS’s Proposal for Regulatory Reform of Industrial Nanomaterials, was strongly supported by stakeholders.

These administrative arrangements will be reviewed following a reasonable period of implementation. Experience gained through administrative amendments will inform any future legislative amendments.

Source: Australian Government - Department of Health and Ageing

Re-Inventing the Wheel : Automotive Nanotechnology – Big Rewards . . . Big Risks [Part 2 of 2]

Tue, 12 Oct 2010 05:58:40 GMT

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.

The State of Nano-Regulations

As vehicle manufacturers start to realize the utility of incorporating parts and components using nanotechnology to improve their performance, regulators in the U.S. and the E.U. are developing nanotechnology regulations that will have implications for their current and planned passenger vehicle applications. Sally Tinkle, senior science advisor to the National Institute of Environmental Health Sciences, acknowledged that "[t]he technology is new enough that we are not yet looking at tires or car bumpers that have nano-elements and which have reached the end of their lives. But we understand the immediacy of these questions and the need to protect public health and the environment."

Regulators say they’re working to understand a complex subject. “There will be some new studies coming out that could tend to increase people’s concern about nanotech,” said Jim Hurd, director of the Green Science Exchange. “But the main thing is that nobody has been able to come up with intelligently designed commercial regulation that protects consumers. One problem is that nanotechnology is not well understood. We’ve had senators ask to see the effects of nanotech, and we’ve had to say, ‘No, no, you can’t see it; a nanoparticle is a billionth of a meter.’ They tend to struggle with understanding it.”

The nanotechnology regulatory environment is both evolving and expanding at all levels of government: federal, state, and even local. At the U.S. federal level alone, a virtual alphabet soup of agencies and departments have jurisdiction over aspects of nanomaterials. To name just a few: EPA, FDA, OSHA, NIOSH and CPSC. And aspects of a number of important statutes apply to nanomaterials. To name just a few: Toxic Substances Control Act, Federal Hazardous Substances Act, Occupational Safety and Health Act, National Environmental Protection Act, Federal Insecticide, Fungicide and Rodenticide Act, and Food, Drug and Cosmetic Act.

The vehicle manufacturing business is, of course, a global business and that makes the regulatory challenges much more complicated. For example, the provisions of European chemicals legislation Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) apply to nanoscale substances, requiring the full range of REACH registration and risk assessment. In addition, concerns about nanomaterial safety have led to the development of larger international frameworks, such as the recent focus on the risks of nanomaterials by the Strategic Approach to International Chemicals Management (SAICM), under the auspices of the World Health Organization, United Nations Environment Programme and others.

The earliest and most extensive exposures to manufactured nanoparticles are likely to occur in the workplace. Vehicle manufacturer and supplier employees, contractors, and others may be exposed to nanomaterials during the manufacturing, maintenance and repair, end use, disposal, or recycling of nanomaterial-containing automotive products. The National Institute of Occupational Safety and Health is significantly involved in studying the potential health and safety impacts of nanotechnology in the workplace (as are similar workplace safety agencies in the EU countries and Australasia). For example, see posts in the "Occupational Health and Safety" topic area of this blog.

Despite the previously slow pace of nanotechnology regulatory action, regulatory movement has started that impacts nanomaterials already used in the motor vehicle industry. See my Sept 22, 2010, post “Nanotechnology Regulation: EPA Issues “Significant new Use Rules (SNURs) for Carbon Nanotubes."

Regulatory action is gaining both traction and speed. For good reason, as outlined below.

Nanomaterial Health, Environment and Safety Risk

The use of engineered nanomaterials (ENMs) is a potential double-edged sword. It is already well-understood that nanoparticles can behave in unexpected ways as a byproduct of their size and their unique properties. And there are good reasons for concern.

First, nanomaterial size and shape facilitates biological and environmental mobility, allowing the movement of nanoscale substances through organisms and the ecological system that would be prohibited to their macro-sized counterparts. Nanoscale devices and particles are hundreds or thousands of times smaller than human cells and many can easily enter most cells and migrate out of blood vessels as they circulate through the body. The limited research so far indicates that some nanoparticles can bypass the human body’s natural defenses against larger particle substances. For example, inhaled nanoparticles can move from the lungs into the blood and then to other organs and ingested nanoparticles also reach the organs much more readily than larger particles. In addition, it has already been observed that some nanoparticles can bypass the blood-brain barrier by entering the nasal passages and traveling along the odor-detecting nerve cells directly into the brain.

Second, aside from size alone, the same characteristics that make nanoscale materials exciting and useful—creation of matter with novel and unique physicochemical properties—may also increase their biological and environmental risk. At the nanoscale materials are not simply miniature versions of macro materials. At particle sizes below 50 nm the laws of classical Newtonian physics give way to quantum effects and altered material properties. What this means is that materials at the nanoscale, relative to the same materials at a macro size, have significantly different chemical reactivity, electrical conductivity, strength, mobility, solubility, and magnetic and optical characteristics.

How do engineered nano-structures, with molecular structures and physical properties heretofore unknown, react in living organisms, including humans? How do ENMs behave in the environment, including air, water, and soil? The answer is that we do not yet know what potential damage, if any, may be caused by the absorption of various type of ENMs into the human body or by their release into the environment. Very little is yet known about the acute or chronic toxicity of ENMs in general or the effects of the various nanoparticle-specific characteristics noted above.

How concerned should we be?

Little is yet known about the acute or chronic toxicity of nanoparticles in general or the effects of various particle-specific characteristics. Although tentative, some early studies suggest that some specific nanoparticles already in use (e.g., carbon nanotubes, nanosilver, nanoclays, nanoTiO2, nanoZnO, other nanometals) may have the potential to cause negative health and environmental consequences. A number of my prior posts specifically discuss these risks in much greater detail.

It is not yet known whether some engineered nanoparticles are simply toxicants under some dose/exposure circumstances, or whether they may also be carcinogens, teratogens, or mutagens. The enabling science and the commercialization of nanotechnology has rapidly outpaced the research to address possible environmental, health, and safety (EHS) hazards and it will take many years for studies about exposure routes, the effects on human health, and effects on the environment to reach what may be viewed as conclusive results. Meanwhile, nanoparticle-containing automotive products are already being manufactured, sold, and disposed of at both the industrial and consumer levels, with dramatic growth.

Big Rewards . . . and Big Risks to the Automotive Industry

The threat of legislation, “over-regulation,” and product liability litigation is unlikely to slow the use of nanotechnology-enabled products on tomorrow’s automobiles. The apparent benefits are too great to slow the trend. And with important applications for EV batteries and other green technologies, it is certain that nanomaterial vehicle content will increase, even while the health, environmental, and safety risks associated with ENMs remains largely unknown.

A recent search of federal and state court dockets and opinion databases found no pending lawsuits alleging nanotechnology exposure. But legal experts agree that nanotechnology tort litigation is not far off.

It has been a fact of American law that new technology breeds new litigation. Experience also teaches that when there are concerns about possible health and safety hazards, tort litigation is not far behind. The question is not so much if, but when, nanotort claims and litigation will arise.

When nanotort claims are made, they can be expected to cover the full range of tort litigation: product liability, both individual and efforts at mass tort/class action; medical monitoring; workers’ compensation; environmental contamination/cleanup; and property damage.

Tort law requires product manufacturers to be knowledgeable experts about the hazards and risks of their products and to test and warn in a manner commensurate with the product use and the known or knowable environmental, health, and safety (EHS) information. For that reason, automotive manufacturers and suppliers must remain continuously aware of ongoing developments in nanomaterial hazard and risk assessment as well as nanomaterial EHS information.

Nanotechnologies are diverse and complex. Nano-related hazards and nano-related risks will be diverse and complex. Vehicle manufacturers/suppliers and their attorneys in this area must understand the fast-moving nanoscience, the large volume and fast pace of ongoing EHS research being conducted worldwide, and the rapidly evolving governmental regulations, industry standards and accepted best practices associated with the specific nanomaterials.

That is a daunting task. Nanotechnology risk assessment and litigation are not areas for dabbling. More than any other existing area of tort and environmental law, knowledge of continuous, real-time developments in nanoscience, EHS research, and government regulations will be needed to provide competent legal and risk assessments, and to defend against inevitable product liability and toxic exposure claims.

Manufacturers that are vigilant and proactive will thrive in spite of the risk.

Nanotechnology Risk and Continuing Insurance Concerns

Fri, 08 Oct 2010 10:31:56 GMT

Nanotechnology is transforming product design and innovation among manufacturers of electronics goods, textiles, cosmetics and foodstuffs as well as in other fields of materials science. However, for insurers, uncertainty still surrounds the increasing use of nanotechnology in products and how safe they are.

An October 6, 2010, article by Lloyd's of London, one of the world's largest insurance markets, discusses the concerns.

An article in the October 7 on-line edition of Insurance Journal also discusses the Lloyd’s article.

Excerpts from the Lloyd's on-line article, “Regulators get to grips with nanotechnology,” are reproduced below.

Regulatory abyss
Despite the increasing use of nano-materials in consumer products and the fact that no one really understands their long-term effects on people and the environment, little specific regulation exists on the use of nanotechnology.

CNTs (carbon nano tubes) for example are one of the most commonly used nano-materials and are now produced on an industrial scale. The market is growing fast and primary production alone is projected to be worth $460m in 2011. By the year 2014 it is estimated that 15% (by value) of all products will contain nanotechnology.

CNTs are microscopic cylinders or needles and in bulk are like fibrous dust. Some fear that they may have similar toxic properties to asbestos if inhaled by workers (or anyone else that comes into contact with them) during production, shipping or use.

Similar forms of nano-materials are used in films and coatings to produce self-cleaning equipment and appliances, for example. Cosmetics firms use nano-materials in skincare products. Yet, the effect of these products on human DNA – or the environment – is still not clear.

Health impact not clear
Lack of understanding of the risks around nanotechnology has led to a regulatory gap with “nanospecific” regulation still lacking in most countries.

Some progress has been made. In Europe, the European Commission’s chemicals registration legislation, REACH, was adopted to address the specific risks of carbon nanotubes in 2008. In March 2009, the EU legislation on cosmetics was adopted for nano-materials, requiring labelling, definition and safety assessment. Additionally, the next European Environment and Health Action Plan is expected to address the challenge of nano-materials among its priority areas.

In 2011, the Commission will also have to respond to the European Parliament Resolution adopted in April 2009, on the regulatory aspects of nano-materials. According to the resolution, various ambitious measures will be taken in order to ensure safety with regard to nano-materials and nanotechnology.

For its part, the Belgian Presidency of the EU has sent out a signal to European and national authorities and scientific and regulatory bodies, so that they take the necessary measures leading to the required regulatory provisions. Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development and Consumer Protection, has put forward five proposals to respond to consumer needs whilst ensuring their safety:
• Define the obligation to inform the consumer of the presence of nano-materials in consumer products.
• Ensure the traceability of the chain so as to be able to return to the source, if necessary. It should be obligatory to maintain a register of nanomaterials.
• Identify the most appropriate regulatory path at the EU level for risk evaluation and management.
• Encourage Member States, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favour of risk management, information and monitoring, and
• Regulate the claims made on labels of products containing nanomaterials.

Federal and state authorities in the U.S. are behind Europe in coordinating their moves to regulate the use of nano-materials. But the EPA recently proposed two new rules for multi-walled and single-walled carbon nanotubes which have yet to be transformed into law. The rules, which may be brought in by the end of the year, will oblige companies to notify the agency at least 90 days prior to the manufacture, importing or processing of CNTs.

In Asian countries, existing regulation has not yet been modified specifically for nano-materials.

How insurance industry can cope
How can the insurance industry best cope with the continuing uncertainty around nanotechnology, the risks and regulation? The CRO Forum, a grouping of chief risk officers in European insurance companies, suggests these preemptive risk mitigation strategies:
• raise clients’ awareness;
• map risk exposure (e.g. improve understanding of how individual clients deal with nanotechnology);
• consider whole life cycle of CNTs and their impacts on traditional lines of business; and
• develop appropriate underwriting measures - on a company by company basis - and adapt them to the facts and circumstances of the individual risks being underwritten.

I also suggest that insurers, risk managers, and others responsible for nanotechnology risk mitigation take the steps outlined in a number of my recent posts:

Reducing Nanotorts in your Company’s Nanofuture: Part 1 of 2

Reducing Nanotorts in your Company’s Nanofuture: Part 2 of 2

I also suggest taking a look at a presentation I made to the Erie Insurance Company, entitled “Nanotechnology: Insurers Guide to Risk Mitigation in 2009.”
as well as my more recent presentation made at the 22nd Annual Product Liability Conference on September 30, 2010, entitled "Nanotechnology Risk Mitigation in 2010."

Source: Lloyd’s of London

Re-Inventing the Wheel : Automotive Nanotechnology – Big Rewards . . . Big Risks [Part 1 of 2]

Thu, 07 Oct 2010 18:34:00 GMT

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:

1. Nano-structured materials/ Nanocomposites/ Nanoparticles
   A. Light weight structure materials
   B. Fire-resistent and thermal protection materials
   C. Strength, hardness and duration improvement
   D. Functional paint and coating/ Smart skins
       a. Self-cleaning
       b. Scratch-resistant
       c. Anti-corrosion
       d. Color effects
       e. Optical performance
   E.Programmable materials
   F.Other functional materials

2. Nanotech based energy generation and storage
   A. Fuel cells
   B. Solar cells
   C. Gasoline catalyst
   D. Energy storage

3.  Ultrafine sensing and monitoring
   A. Motion monitoring
   B. Pressure monitoring
   C. Inclination monitoring
   D. Biometric systems
   E. Climate sensing

4. Nanoelectronics
   A. Smart engine management
   B. Displays and lighting
   C. High temperature electronics
   D. Security controlling
   E. Long-lasting batteries

5. Data processing and communication
   A. Image processing
   B. In-vehicle telematics
   C. Multimedia architecture
   D. Artificial intelligence

I've described a handful of specific examples currently in use in more detail below:

Adhesives: Nanoparticle-enhanced adhesives are already being used in some areas of car assembly. Experts say that in the near future most automobiles will be almost entire held together with glues strengthened by nanoparticles, replacing traditional welding and other joining techniques.

Trim Components: Lightweight, high performance nanocomposite materials using carbon nanotubes have been developed for applications in exterior claddings, interior parts, and in non-support trim. GM introduced the first commercial automotive exterior application of nanocomposite material on the step assist of the 2002 GMC Safari and Chevrolet Astro vans. In January 2004, GM expanded its use of nanocomposite material, introducing it on the body side moulding for the ’04 Chevrolet Impala. Its use has expanded to other components and other vehicles since then. There is lots to like from an engineering standpoint about carbon nanotube structures 100X stronger than steel at lower mass.

Tires: LANXESS, one of the world’s leading manufacturers of synthetic rubber, is using nano-sized particles made from polymerized styrene and butadiene, the traditional tire rubber raw materials, to manufacture tires that are longer-lasting and grip the road better than existing tire rubber formulations. “Our Nanoprene rubber is being tested by a lot of companies worldwide for different types of tires,” according to Werner Obrecht, rubber expert at the Technical Rubber Products business unit of Lanxess. “The additive prolongs the mileage of the tires by 15%, enhances grip by the same amount, and also reduces rolling resistance.”

Tire-maker Yokohama's S.Drive tires use a breakthrough micro-flexible compound developed using nanotechnology for exceptional traction. Using nanomaterials the silica-based compound conforms to surface irregularities, maximizing road contact for better road adhesion in wet & dry conditions.

InMat Inc., a New Jersey-based company, has developed a coating for tires that mixes nanoparticles of clay with plastics and conventional synthetic rubber. The smaller nano-clay particles dramatically reduce the rate at which oxygen can escape, which means the tires decay much more slowly.

Paint: Automotive paints are already coming into commercial production that use nanotechnology to migrate silicon particles to the outer surface of the coating, creating an extremely thin, hard, glass-like surface three times more scratch-resistant than conventional non-metallic or metallic paints. U.S.-based PPG Industries Inc. has produced a nano-based scratch-free paint, CeramiClear, in collaboration with Mercedes-Benz.

Filters: Under the hood of BMW’s models is a catalytic particulate filter coated with carbon nanotube membranes that break up hydrocarbon deposits created by burnt fuel re-entering the combustion chamber. The nano-enabled filters can remove up to 99% of particulates with diameters of less than a micrometer. That is a dramatic improvement over filters without nanomaterials.

Catalytic converters: Nanotechnology promises better and cheaper catalytic converters, important to further green vehicle technology. The toxic byproducts made when a car’s engine burns fuel are funneled into the catalytic converter, where chemical reactions turn them into much less toxic substances like water and carbon dioxide. A problem is that the catalyst that lowers the activation energy of these chemical reactions so that they can take place at reasonable temperatures and speeds is usually platinum, one of the world’s rarest and most precious metals. Because platinum is so expensive, automakers want to use as little as possible, and to use it as effectively as possible. To maximize its specific surface area (surface area per unit mass) and therefore its chemical reactivity, manufacturers coat a ceramic support with small particles of platinum. But when the converter gets hot, the platinum aggregates, forming large clumps that cannot carry out the detoxification reactions as effectively. To compensate for the loss of efficiency, converters must contain more platinum, a scarce metal badly needed for other clean-energy applications, such as fuel cells.

A new nano-material enabled catalytic system, described online in the September 27, 2010, German Chemical Society's Journal Angewantde Chemie International Edition, prevents the platinum from aggregating, so that less is needed for each converter. The key development is the use of new materials -- platinum nanoparticles and titanium dioxide nanofibers.

The use of nanomaterials will allow the use of much less platinum by volume while achieving even greater catalysis, so cars cost less, more of the scarce metal is available for other uses, and emissions are further reduced.

Batteries: Perhaps the most revolutionary and beneficial use of nanotechnology is coming in the form of advanced battery technology. Manufacturers are constantly striving for better batteries that offer improved conductivity, longer charge life and shorter recharge time. These elements are all critical to the evolution of li-ion batteries. Nanotechnology has shown to improve upon these features, enabling battery manufacturers to offer a better battery to OEMs. EV battery suppliers such as A123Systems, Panasonic, and Samsung are using nanomaterials to make significant improvements in lithium-ion battery performance that will, within a short time, allow for all-electric vehicles with significantly greater battery capacity, range, and lifespan, all critical to continued growth of the EV market.

In the second half of this blog article, I will outline the likely risks of the nano-boom to automotive manufacturers and suppliers.

Nano-Pesticide Environmental, Health and Safety Risk

Tue, 05 Oct 2010 09:13:41 GMT

One of the most exciting new developments in pesticides is the prospect of nanopesticides. Nanotechnology is being used to develop pesticides with new or enhanced activity, or more targeted application (such as through microencapsulation or affinity for specific target pests).

Pesticides are regulated under several laws, primarily the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) which authorizes EPA to oversee the registration, distribution, sale, and use of pesticides. The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. The EPA’s Office of Pesticide Programs has already formed a Nanotechnology Work Group to develop a regulatory framework for nanopesticides. Two recent OPP presentations are instructive.

“Nanotechnology and Pesticides” presentation was made in April 2010, at the EPA Pesticide Program Dialogue Committee (PPDC) meeting. The April 2010 OPP presentation included the following:

“Why is OPP Concerned?

Potential Human Health Concerns:
- Dermal absorption (so small they may pass through cell membranes)
- Inhalation (go to the deep lung and may translocateto the brain i.e, could cross the blood brain barrier)

Potential Environmental Concerns:
- High durability or reactivity of some nanomaterials raises issues on the fate in environment
- Lack of information to assess environmental exposure to engineered nanomaterials.”

For a good summary of the nanotechnology pesticide issues discussed at the PPDC meeting, see http://nanotech.lawbc.com/2010/05/articles/united-states/federal/ppdc-discusses-nanotechnology-and-pesticides/

“EPA Regulation of Pesticides Containing Nanoscale Materials” presentation was made in September 2010, at the meeting of the State Federal Insecticide, Fungicide, and Rodenticide Act Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee. The September 2010 OPP presentation included an indication that EPA intends to require that nanoproducts be labeled in some fashion under FIFRA.

The EPA is of course not the only organization working on this issue. In a study published on October 4, 2010, in the International Journal of Occupational and Environmental Health, scientists from Oregon State University and the European Union outline six regulatory and educational issues that should be considered whenever nanoparticles are going to be used in pesticides.

Acknowledging that nanotechnology is about to emerge in the world of pesticides and pest control, the researchers observe that a range of new approaches are needed to understand the environmental, health, and safety implications for public health, in order to ensure that this is done safely, to maximize the potential benefits, and to minimize possible risks.

"The emergence of nanotechnology in the pesticide industry has already begun, this isn't just theoretical," said David Stone, an assistant professor in the OSU Department of Environmental and Molecular Toxicology. "But pesticides are already one of the most rigorously tested and regulated class of compounds, so we should be able to modify the existing infrastructure."

"If we do it right, it should be possible to design nanoparticles with safety as a primary consideration, so they can help create pesticides that work better or are actually safer," said Stacey Harper, an assistant professor of nanotoxicology at Oregon State University. Harper is a national leader in the safety and environmental impacts of this science that deals with particles so extraordinarily small they can have novel and useful characteristics.

"Unlike some other applications of nanotechnology, which are further along in development, applications for pesticides are in their infancy," Harper said. "There are risks and a lot of uncertainties, however, so we need to understand exactly what's going on, what a particular nanoparticle might do, and work to eliminate use of any that do pose dangers." A program is already addressing that at OSU, as part of the Oregon Nanoscience and Microtechnologies Institute.

The positive aspect of nanotechnology use with pesticides, researchers say, is that it might allow better control and delivery of active ingredients, less environmental drift, formulations that will most effectively reach the desired pest, and perhaps better protection for agricultural workers. "If you could use less pesticide and still accomplish the same goal, that's a concept worth pursuing," Harper said.

But researchers need to be equally realistic about the dangers, she said. OSU labs have tested more than 200 nanomaterials, and very few posed any toxic concerns – but a few did. In one biomedical application, where nanoparticles were being studied as a better way to deliver a cancer drug, six out of 40 evoked a toxic response, most of which was linked to a specific surface chemistry that scientists now know to avoid.

One important concern, the researchers said, will be for manufacturers to disclose exactly what nanoparticles are involved in their products and what their characteristics are. Another issue is to ensure that compounds are tested in the same way humans would be exposed in the real world. "You can't use oral ingestion of a pesticide by a laboratory rat and assume that will tell you what happens when a human inhales the same substance," Stone said. "Exposure of the respiratory tract to nanoparticles is one of our key concerns, and we have to test compounds that way."

Future regulations also need to acknowledge the additional level of uncertainty that will exist for nano-based pesticides with inadequate data, the scientists said in their report. Tests should be done using the commercial form of the pesticides, a health surveillance program should be initiated, and other public educational programs developed.

Special assessments may also need to be developed for nanoparticle exposure to sensitive populations, such as infants, the elderly, or fetal exposure. And new methodologies may be required to understand nanoparticle effects, which are different from most traditional chemical tests. "These measures will require a coordinated effort between governmental, industry, academic and public entities to effectively deal with a revolutionary class of novel pesticides," the researchers concluded in their report.

Sources: EPA, Oregon State University

Nanotechnology Standards: New ASTM subcommittee on "Nano-Enabled Consumer Products"

Mon, 04 Oct 2010 08:11:52 GMT

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:

- Standards for measurement of silver in textiles and liquids (including atomic spectroscopy to assess mass);

- Standards for evaluating the form of silver in textiles and liquids (including: electron microscopy to evaluate size, shape and chemical composition; ultraviolet-visible spectrophotometry to evaluate size using surface plasmon resonance absorbance); and

- Standards for assessment of nanosilver exposure potential from use of textile and liquid consumer products (including: release from consumer products in biological fluids [skin surface, lung, gastrointestinal tract]; release from consumer products in environmental matrices [air, water, soil] throughout a product lifecycle).

Although just the start of a lengthy standards development process, this is a significant development that will eventually impact nanoparticle exposure litigation, as I described in a number of my earlier posts concerning the important role of nanotechnology standards in future nanotort litigation.

About ASTM Committee E56

ASTM Committee E56 on Nanotechnology was formed in 2005. E56 meets once a year in May and as needed in the fall. This Committee addresses issues related to standards and guidance materials for nanotechnology & nanomaterials, as well as the coordination of existing ASTM standardization related to nanotechnology needs. The Committee, with a membership of approximately 225 representing 22 different countries, currently has its standards published in the Annual Book of ASTM Standards, Volume 14.02. E56 has 4 technical subcommittees that maintain jurisdiction over these standards, including subcommittee E56.03, Environment, Health, and Safety.

For more information visit the ASTM Committee E56 Webpage at www.astm.org/COMMIT/E56

Source: ASTM International

Nanotechnology and Food Safety – New Report September 2010

Tue, 28 Sep 2010 13:34:35 GMT

In late September 2010, The Centre for Food Safety (CFS), an arm of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China, published a risk assessment study “Nanotechnology and Food Safety.”

The aims of the study were:

- to identify applications of nanotechnology in the food sector
- to identify the potential health and safety implications of nanotechnology in the food sector; and
- to review existing strategies for the risk assessment of engineered nanomaterials in food.

Some key excerpts from the CFS Study are included below.

APPLICATIONS OF NANOTECHOLOGY IN THE FOOD SECTOR

Application of nanotechnology in the production of food contact materials
Food packaging makes up the largest share of current and short-term predicted markets of the use of nanotechnology in the food sector. The addition of nanoparticles into shaped objects and films has been shown to improve properties of the packaging materials with regard to durability, temperature resistance, flame resistance, barrier properties, optical properties and recycling properties.

Examples of food contact materials currently available in the market include PET (polyethyleneterephthalate) beer bottles with nano-clay gas-barrier, polypropylene food containers with nano-silver for antimicrobial action, nano-zinc oxide containing film for food wrapping, and biosensors for monitoring condition of food during storage and transportation

Nanoencapsulation of food ingredients and additives
Nanoencapsulation is currently the second largest area of nanotechnology application in the food sector. It is used as a strategy to harness a controlled delivery system for food ingredients and additives in processed food. Nanoencapsulation is the technological extension of microencapsulation. Compared to microencapsulation, which has been used by the industry for many years, nanoencapsulation is a new emergent. Nanocarrier systems can be used to mask the unpleasant tastes and flavours of ingredients and additives such as fish oils, to protect the encapsulated ingredients from degradation during processing and storage, as well as to improve dispersion of water-insoluble food ingredients. However, current studies on the application of nanoencapsulation mainly address its potential for target delivery of active ingredients of functional food and nutraceuticals.

A schematic diagram of nanoencapsulation is shown:

By controlling the surface properties of the nanoparticles, they can be used to encapsulate the bioactive compounds in food. The release of the encapsulating active ingredients from the nanostructure can be triggered by exposure to appropriate environmental conditions (e.g. pH and salt concentration) or through interaction with selected proteins and cells in the body, thus providing a means to deliver the active compounds to the target site. It is projected that the addition of nanocapsules to processed foods will improve both the availability and delivery of nutrients, thereby enhancing the nutritional status of food

While the concept of nanodelivery systems can enhance the absorption, uptake and bioavailability of nutrients and supplements, it also has the potential to alter the distribution of the substances in the body. That leads to health and safety concerns.

Nanostructured food ingredients and additives
A major focus of current nanotechnology application in food is the processing and formulation of food ingredients to form nanostructures. Nanostructured food ingredients are already available in some health foods, supplements and nutraceutical products. The mechanisms commonly used for producing nanostructured food products include nano-emulsions, emulsion bilayers and reverse micelles.

Examples of nanotextured food products include spreads, ice-creams, yogurts, mayonnaise, etc. This category of nanofood is being developed with claims that they offer improved taste, texture and consistency, enhanced bioavailability and allow mixing of “incompatible” ingredients in food matrix. It can also be used to produce low-fat nanotextured food products that are as “creamy” as the conventional full-fat equivalent, and hence offers a “healthy” option to the consumer.

BEHAVIOR AND FATE OF NANOMATERIALS IN THE GASTROINTESTINAL (GI) TRACT

Absorption
Nanomaterials present in food may be readily absorbed from the GI tract. Translocation of nanomaterials through the epithelium of the intestinal wall depends on their physiochemical properties, for example, size, surface charge, lipophilicity/hydrophilicity, presence/absence of a ligand, and physiology of the intestinal tract>

It is also possible that the ingested nanomaterials may not remain in a free form in the lumen due to transformations such as agglomeration, aggregation, adsorption or binding with other food components, and hence are not readily available for translocation through the intestinal wall. Currently only limited information is available on the absorption of nanomaterials after ingestion.

Distribution
Upon contact with the intestinal sub-mucosal tissue, the ingested nanomaterials can enter the capillaries, which will carry them through the portal circulation to the liver, or they enter the lymphatic system via the thoracic ducts. Experimental data demonstrated that the distribution of nanoparticles after oral administration is dependent upon particle size. Smaller-sized nanoparticles have a more widespread tissue distribution to organs like kidney, liver, lungs and brain while the bigger particles (28 nm and 58 nm) remain almost solely inside the GI tract. Studies have been performed on the ability of nanoparticles to penetrate the placental barrier. There is also information that certain nanomaterial (C60 fullerene) can pass across the placenta. However, due to the inconsistent results of some in vitro and animal studies, no general conclusion on the penetration power of nanoparticles across the placental barrier can be made. There is currently no information on whether nanomaterials are transferred into milk.

Excretion/elimination
There is very limited information on the excretion of absorbed nanomaterials.

CONCERNS AND HEALTH IMPLICATIONS FOR APPLICATION OF NANOTECHNOLOGY IN FOOD

Nanoparticles as indirect sources of food contaminants
The growing use of materials, products and applications of nanotechnology may pose new indirect sources of food contamination with nanoparticles. Such risk of exposure may arise from the use of nano-sized pesticides and veterinary medicines, contact of food with nanoparticulate-based coatings during preparation or processing, or potential migration of nanoparticles from food packaging. Because of the small sizes, these nanoparticles may enter the food chain undetected, accumulate within tissues and organs, and can be taken up by individual cells. There is also concern that the introduction into food of nanoparticles designed to carry dietary supplements could also lead to introduction of foreign substances into the bloodstream.

Alter the absorption profile and metabolism in the body
The processing of food ingredients into nano-size may make them different from those that exist naturally. This change in properties of the nano-scale processed foods may also alter how the food ingredients behave upon breakdown with the gut and, as a consequence, how they are treated in the GI tract.

It is not only the nanomaterials that may trigger biological effects. Nano-sized materials may interact with proteins and other compounds and act as carriers of these substances into different biological tissues. It has been suggested that the carrier potential of nanomaterials might impact the absorption of molecules, for example by introducing unintended molecules across the GI tract, leading to unintended effects.

It has been evidenced that the consumption of nano-sized food ingredients has the potential to alter body metabolism of experimental animals. At present, there is currently not much information regarding metabolism/biotransformation of nanomaterials after oral administration in the human model.

The changed absorption profile and possible metabolism effects creates complications for the exposure assessments of these novel materials within the body.

Unknown toxicity of food-chain nanoparticles

Oral exposure studies
Most research on the toxicology of nanomaterials addresses inhalation exposure and occupational hazards associated with the manufacture and handling of nanostructured materials. Oral studies have so far been limited to acute dosing and no long-term studies have yet been conducted. The 2009 "FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors: Potential Food Safety Implications" has pointed out that the quality of many of the published oral toxicity studies is questionable, severely limiting the use of the information.

The current state of knowledge does not permit reliable prediction of the toxicological characteristics of any given nanomaterials from data on other nanomaterials or from a consideration of the characteristics of the nanomaterials itself. No data on genotoxicity, or on possible carcinogenesis and teratogenicity, is available for nanoparticles yet.

In vitro studies
There is a wealth of in vitro studies of nanomaterials in human or animal cells and a range of nanomaterials, concentrations and exposure times have been studied, and show the following:.
- Potential to cross cellular barriers and cause oxidative damage
- Potential for brain-cell damage
- Potential to cause impairment of DNA replication and transcription

Although potential toxicity of certain nanomaterials has been demonstrated in a number of in vitro studies, there are limitations of such studies that do not reflect the toxicity of the nanomaterials in food. Typical problems have been administration of physiologically non-relevant doses, aggregation of particles, direct exposure of the cells to nanomaterials. and the uncertainty in the interaction between nanomaterials and other food components.

Lack of analytical method/predictive model to evaluate safety of nanoparticles
In face of the novelty of the nanoparticles, our conventional knowledge about health effects of chemical and materials, which is based on their chemical and physical properties, may not be applicable when dealing with nanoproducts. Because the methods for identifying and establishing the relevant hazards of different chemicals were developed for molecular form of materials, and nanoscale materials may behave differently, the available analytical methods may not be sufficient to support decisions about the biological effects of nano-sized particles. In summary, there are methods available to detect and analyze nanomaterials under certain conditions, but there are no routine methods available for analyzing food-product nanomaterials.

RISK ASSESSMENT OF NANOMATERIALS IN FOOD

A number of national and international advisory committees have recommended strategies for the risk assessment of nanomaterials. However, there is currently no comprehensive guidance developed particularly for the safety assessment of nanomaterials in food. A difficulty in giving detailed specific risk assessment guidance in the area is the lack of sufficient data and information which would allow for a comprehensive understanding of potential hazards of nanomaterials.

World Health Organization (WHO) and Food and Agricultural Organization of the United Nations (FAO)
Given the increased global interest in the use of nanotechnology and concerns about the potential food safety implications, in 2009 the FAO and WHO convened the “FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors: Potential Food Safety Implications” to provide information on what was currently known about potential food safety risks, identify potential food safety implications associated with applications of nanotechnologies in the food sector, as well as to review current risk assessment methodologies to evaluate the safety of nanomaterials in the food-chain.

European Food Safety Authority (EFSA)
On the request of the European Commission, EFSA provided a scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety in February 2009. The EFSA Scientific Opinion, The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, recognized that the formulation at the nanosize may change the physiochemical characteristics of materials as compared to the dissolved and micro/macro forms of the same substance. The small size, high surface-to-mass ratio and surface reactivity of the nanomaterials are important properties, both for new applications and in terms of the associated potential health and environmental risks.

Health Canada
In Canada, any new additive and food products which fall under the definition of “novel food” are subject to pre-market safety assessments before being introduced to the food supply. The use of nanomaterials as a component of food or used to produce food products are currently subject to the same health and safety regulations that apply to conventional materials. Health Canada considers the Food Additive Regulations, Novel Food Regulations, and Food and Packaging Materials Regulations to be relevant for food products that use or are derived from nanomaterials.

CONCLUSIONS AND RECOMMENDATIONS

The CFS Report reached several conclusions:

1. There is currently no internationally agreed definition for “nanotechnology.” A clear and internationally harmonized description of the technology would help to define the scope for safety assessment and regulation of the application of nanotechnology in food.

2. As methods for detection and characterization of nanomaterials in food were not readily available, in many instances the claimed nanoscale character of the applications could not be verified. Knowledge regarding the presence of nanomaterials in food products relies on information provided by the industry, producers and marketing organizations.

3. At present, there is no tenable evidence that food or food contact materials derived from nanotechnology is any safer or more dangerous than their conventional counterparts. No general conclusions can yet be made on the safety of nanofood and food contact materials incorporated with nanomaterials. Most scientific committees that have reviewed the applications of nanotechnology concluded that while consumers are likely to benefit from this technology, new data and new measurement approaches may be needed to ensure that the safety of products using nanotechnology are properly assessed.

4. Many regulatory authorities have evaluated their framework of regulation and approval of food ingredients to ensure the currently adopted systems can fully encompasses the use of nanotechnology in food and food-contact materials. The approaches for safety evaluation of nanomaterials vary from country to country but presumably follow similar pathways to those used for other materials proposed for use in food and food contact materials.

Details of the CFS risk assessment study are available on the CFS website at http://www.cfs.gov.hk/english/programme/programme_rafs/programme_rafs_ft_01_04.html

To see the CFS Report and PowerPoint , click on either one below:

Nanotechnology and Food Safety Report

Nanotechnology and Food Safety PowerPoint

Nanotechnology in the Food Chain – Opportunities & Risks

Sun, 26 Sep 2010 15:20:56 GMT

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/

Of particular interest for those of us in the food safety and nanorisk fields will be the following agenda subjects:

Theme 3: Toxicological aspects of nanotechnology in the food chain
Items to be addressed:
- Toxicological properties (acute/chronic toxicity, genotoxicity, …)
- Toxicokinetics & toxicodynamics
- Toxicity at the level of cells, animal tissue, etc. (in silico - in vitro - in vivo)
- Toxicodynamic aspects of nanoparticles in food: interactions with the intestinal barrier
Main questions to be answered:
- How to determine the toxicity of nanoparticles?
- What are the uncertainties regarding the toxicity of nanoparticles (e.g. metric dose)?
- What is known about the oral toxicity of nanoparticles (absorption, bio-availability, intestinal toxicity, ...)?
- What are the health & safety issues of nanoparticles in food?

Theme 4: Risk assessment - EFSA's point of view
Item to be addressed:
- Risk assessment of the use of nanotechnology in the food chain.
Main questions to be answered:
- What are the health & safety issues of nanoparticles in food?
- Which risk assessment issues need to be addressed for nanotechnology in food?
- Is there a prioritization with respect to research needs?

Theme 6: Regulatory aspects
Items to be addressed:
- International – European – national level
- Legislation regarding the food chain (REACH, labelling, etc.)
- Regulatory challenges of nanotechnologies
- International standards
Main questions to be answered:
- Are nano-applications in the food chain covered by the current legislation?
- How to control nano-applications in the food chain?
- Is there a need for a specific “nano-legislation”?

I expect that the U.S. FDA and U.S. Dept. of Agriculture will be watching the EFSA Symposium closely to help inform their respective assessments of the agriculture and food safety aspects of nanotechnology.

Nanotort Law Blog Going Strong at One-Year Anniversary!

Thu, 23 Sep 2010 09:42:22 GMT

We are pleased to see our nanotechnology law blog going strong after one year! The Nanotort Law Blog, which launched last September to provide a valuable information resource aimed at informing lawyers, claims handlers, risk managers, and media on issues not readily available elsewhere on emerging risks associated with new technologies.

Led by Bowman and Brooke Partner Ron Wernette, the Nanotort Law Blog offers readers up-to-date information about litigation risks and risk management in the fast-developing field of nanotechnology.

Click here to read more on www.bowmanandbrooke.com.

Now you can follow the Nanotort Law Blog on Twitter! Follow Ron @nanotortlaw or click here: http://www.twitter.com/nanotortlaw.

Nanotechnology Regulation: EPA Issues “Significant New Use Rules” (SNURs) for Carbon Nanotubes

Wed, 22 Sep 2010 16:20:00 GMT

The EPA on September 17, 2010, published final Significant New Use Rules (SNURs) for both single-walled and multi-walled carbon nanotubes. Those types of carbon nanotubes are the most commonly used nanomaterial in industrial applications and are gaining increasingly widespread use in a variety of consumer products.

Many nanoscale materials – including nanotubes – are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. This four-pronged approach includes: Premanufacture notifications; Significant New Use Rules; an information gathering rule; and a test rule.

The new SNURs are the first to deal specifically with engineered nanomaterials and are very important because they demonstrate the EPA's clear understanding that it can and will regulate intentionally manufactured nanomaterials.

The SNURs will require companies to provide the EPA with 90 days notice if they intend to manufacture or import the SWNTs or MWNTs, allowing the agency time to review the safety of their intended use and to determine if additional data or restrictions are warranted. The company making or importing the two types of carbon nanotubes will also have to comply with the restrictions EPA has already imposed upon their original manufacturer.

In addition, the new carbon nanotube SNURs would also:

1. Require any new manufacturer of these nanotubes to protect its workers.

2. Ban releases of the nanotubes into water.

The SNURs are effective on 10/18/2010. To read the comments submitted and supporting materials, go here.

For more information about EPA’s nanoscale material SNUR process, see http://www.epa.gov/oppt/nano/#snur, as well as http://www.epa.gov/opptintr/newchems/pubs/cnosnurs.htm

Source: EPA, The Bureau of National Affairs' Daily Environment Report

EU Nano-Regulation: Specific Nanomaterial Register under REACH and Mandatory Labeling for Consumer Products?

Fri, 17 Sep 2010 07:33:56 GMT

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".

Magnette seemed to strike a balance between calls for a moratorium on nanomaterials based on the precautionary principle and arguments from industry groups, which say their potential risks to human health are have not been proven. The so-called "no data, no market" principle, which would establish a de facto moratorium, would be too restrictive, Magnette said. But he also criticized a posture where only the merits of nanomaterials are currently being put forward by industry.

This week’s remarks follow a report a few months ago from the French Agency for Environmental and Occupational Health Safety (AFSSET), which called for the REACH legislation to be rewritten to specifically address manufactured nanomaterials. AFSSET's report, "Evaluation of Risks Linked to Nanomaterials for the General Population and for the Environment", recommended acting immediately to require all nanomaterials to be traceable, to require labeling of products containing nanomaterials, and to ban nanomaterials for uses in which their utility is outweighed by potential risks.

The AFSSET report identifies several hundred consumer products containing nanomaterials and says that "[N]ew studies suggest possible risks for health and the environment linked to certain of these products," particularly antibacterial socks containing nanosilver, quick dry cement and sunscreen containing titanium dioxide, and nanometric silica used in food products.

EU to Complete Regulatory Review of Nanomaterials by end 2011 ?

After a first review in June 2008, the EU Commission is committed to completing its second regulatory review of nanomaterials by the end of 2011.

The European Commission's department for enterprise and industry has stated that the 2011 review will focus on the specific inclusion of nanomaterials under the REACH regulations, and that all aspects related to exisiting environmental legislation on water, waste, and air - as well as worker safety - will be addressed.

If you do business in the EU, or have clients that do, it is critical that you watch these moves closely.

Nanotech Health and Safety Program at NanoBusiness 2010, September 27- 28

Wed, 15 Sep 2010 10:23:08 GMT

The NanoBusiness Alliance, the world's leading nanotechnology trade association, will hold the 9th annual NanoBusiness 2010 conference and exhibition, at McCormick Place in Chicago on September 27-28. For event details, including the conference schedule and registration information, visit http://www.nanobusiness2010.com.

This year’s conference focuses on the issues that are of top-line importance to the NanoBusiness Alliance’s constituents, and includes sessions on:

- Innovations In Nanotechnology

- Creating an Ecosystem for Nanotechnology Commercialization

- Environmental, Health and Safety

- Nanomedicine

The event will also address nanotechtology from a government perspective, including a National Nanotechnology Initiative (NNI) legislative update, and a look at the current regulatory environment.

Speakers during the Environmental, Health and Safety program are scheduled to include:

Philip Lippel, PH.D., Consultant Nanoscience & Emerging Technologies

Rosalind Volpe, PhD, Executive Director, Silver Nanotechnology Working Group, A Program of Silver Research Consortium LLC

Shaun F. Clancy, Ph.D., Director, Product Regulatory Services, Evonik Industries

Kenneth T. Moss, Leader, Notice and Regulations Team #2, U.S. Environmental Protection Agency, New Chemicals Management Branch, Office of Pollution Prevention and Toxics

Nina Horne, M.P.P., University of California-Berkeley, City Commissioner

“In the year since our last NanoBusiness Conference, our industry has been faced with both new opportunities and challenges, and it’s at our annual gatherings that leaders from the worlds of nanotechnology, finance and government come together to address these issues, and set the course for the year ahead,” said Vincent Caprio, Executive Director, NanoBusiness Alliance and Event Director. “It’s for this very reason that our NanoBusiness Conferences have become the industry’s premiere events, and we look forward to welcoming our esteemed group of participants back to Chicago this month.”

About The NanoBusiness Alliance:
The NanoBusiness Alliance is the industry association for the emerging nanotechnology industry. Through its extensive network of leading startups, Fortune 500 companies, research institutions, non-governmental organizations and public-private partnerships, the Alliance shapes nanotechnology policy and helps accelerate the commercialization of nanotechnology innovations. The NanoBusiness Alliance has offices in Chicago, New York, Connecticut and Washington, DC. For more information, visit http://www.nanobusiness.org.

Nanotechnology VI Symposium: “Progress in Protection” in October 2010

Sun, 12 Sep 2010 10:12:15 GMT

Nanotechnology VI Symposium: “Progress in Protection” is co-sponsored by the California Department of Toxic Substances Control (DTSC) and the University of California Los Angeles’ Center for the Environmental Implications of Nanotechnology (UC-CEIN). The symposium will build on topics discussed at DTSC’s previous nanotechnology symposiums. It also emphasizes occupational safety and health concepts, which are keys to reducing potential risks to workers and the environment from engineered nanomaterials (ENMs).

Discussion topics will include:

- Collaboration between DTSC’s Office of the Chief Scientist, the National Institute for Occupational Safety and Health (NIOSH) and California’s leading universities to fill data gaps via the development of ENM risk-based guidelines.

-Practical insights from current nanomaterial manufacturers regarding health and safety.

More specifically, the current agenda includes the following topics/speakers:

NIOSH Nanotechnology Efforts, Paul Schulte, Ph.D. – NIOSH

NIOSH Nano Field Research Team, Mark Methner, Ph.D., CIH – NIOSH

Nanotechnology Industry Survey Overview: Nanomaterial Eco-Toxicology Impacts, Trish Holden, Ph.D. – UC Santa Barbara

Nano EH&S Experience of BASF, Raymond David, Ph.D. – BASF Corp.

Nano EH&S Experience of Quantumsphere, Brendan McKenny, Quantumsphere

Nano EH&S Research Challenges and Opportunities, Hilary Godwin, Ph.D. – UCLA CEIN

Legal, Environmental, & Financial Implications of Failing to Address Nano EH&S, Professor Tim Malloy – UCLA

The program has high credibility, and professional certification maintenance points have been authorized by the American Board of Industrial Hygiene, the Board of Certified Safety Professionals and the Registered Environmental Health Specialist Program.

Date/Time: Wednesday, October 13, 2010, 9:00am – 4:30pm
Location: California NanoSystems Institute (CNSI)
University of California, Los Angeles
570 Westwood Plaza,Building 114
Los Angeles, CA 90095

The event will also be webcast. Registration will accommodate either preference by attendees.

Nanotechnology Risk – New Study from German Federal Institute for Risk Assessment (BfR)

Sun, 05 Sep 2010 09:09:21 GMT

In Germany the early detection of health risks in consumer-related areas is the responsibility of the Federal Institute for Risk Assessment (BfR). In this context it has developed, together with the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Environmental Agency (UBA), a research strategy to identify the potential risks of nanotechnology. The goal of this research strategy is to structure this research area, to develop methods for the measurement and characterization of nanoparticles, to collect information on exposure, toxicological and eco-toxicological effects, and to promote the development of a risk–based test and evaluation strategy.

When questions about the safety and the potential risks of nanotechnology were becoming increasingly pressing, the BfR in 2006 began to carry out the interdisciplinary research project “Delphi Study on Nanotechnology - Expert Survey of the Use of Nanomaterials in Food and Consumer Products.” Parts of the study were undertaken in cooperation with the Centre for Interdisciplinary Risk Research and Sustainable Technology Development (ZIRN) of Stuttgart University. The goal of this project was to lay the foundations for future BfR risk assessments of nanotechnology applications.

In September 2010 the results of the BfR Nano Delphi study were published, offering a detailed discussion of each of the basic nanostructured substances currently on the market, as well as across a variety of product uses. This work is very helpful for those currently tasked with assessing and managing the likely future risks associated with nanomaterial usage.

The “Delphi method” as an instrument of early risk assessment

The Delphi method was adopted in this work. This methodology is frequently used for the purposes of technology forecasting but also for the early detection of unclear risks of new technologies. It is based on structured group surveys and draws on both the participants’ knowledge and intuitive information. The Delphi method is founded on the assumption that experts assess risks on the basis of information which may be of differing quality (own research, primary and secondary literature,media reports, experience etc) and which comes from different assessment contexts (scientific discipline, interests, values, attitudes, etc). The exchange of knowledge over several Rounds has the advantage that feedback processes are possible which encourage participants to re-examine their own evaluation. As a rule, the spectrum of assessments is reduced, trends become clearer.

The Nano Delphi Study

In the Nano Delphi, a total of 100 experts were asked to identify and assess the potential risks of nanotechnology applications in the areas food, cosmetics, surface coatings and textiles. One-third of the participants came from industry (basic substance manufacturers, users from the food, cosmetics, textile and surface industry, associations), one-third from scientific institutions (basic and application-oriented research) and one-third from institutions which deal rather with the risks of nanotechnologies (public authorities, environmental organizations, consumer protection associations, trade unions, technology impact assessment institutions/networks, insurance companies).

Study Conclusions on the Risks of Nanomaterials

Hazard
• The assessment by the experts of the toxicity of nanomaterials did not supply a clear picture. At the current time no meaningful risk assessment is possible on the basis of critical, easily identifiable factors like for instance size, shape or solubility.
• For each application context a specific database must be established before a coherent description of toxicity potentials and mechanisms of action can be given. To this end 18 factors were elaborated which must be used to assess nanomaterials in the concrete application context.
• Based on the results there is a clear tendency for airborne nanomaterials to be assigned high toxic potential far more frequently than in all other aggregate states.
• Oxidative stress, inflammation processes and genotoxic effects were described as the most important mechanisms of action for the toxic effects of nanomaterials.
• The possible carcinogenicity of nanomaterials is linked above all to surface reactivity, the type of nanosubstance, its potential to produce free radicals and the persistence of nanomaterials.

Exposure
• Experts expect to see a moderate to major increase in the consumption of nanomaterials and resultant increases in employee and consumer exposures to nanomaterials. The market for carbon-based nanomaterials and nanocomposites is seen as being particularly dynamic.
• In the opinion of experts the inhalational exposure pathway is the most critical one. This is where negative health effects resulting from exposure to nanomaterials are most likely. However, employees are the most probable group who will be affected by inhalational exposure. Here corresponding health and safety measures need to be taken.
• In the case of the oral intake of nanoparticles the theory that metal nanoparticles can be ingested by the organisation is not rejected and it is assumed that no specific receptors were necessary in order for nanoparticles to be ingested via the gastrointestinal tract.
• The protective function of healthy skin against exposure to nanoparticles is confirmed by the majority. A majority of the experts likewise believe that injured skin has an impaired protective function. If nanomaterials are embedded in a solid matrix, most of the experts expect low dermal absorption exposure.
• Overall the experts warn against general statements and advocate case-by-case consideration

Additional risk assessment criteria
• Bioavailability of nanomaterials, their persistence, and a generally inadequate knowledge base for these materials are the most important criteria which should be included in future extended risk assessments.
• The importance of the inclusion of additional assessment criteria for nanoproducts increases from surface coatings over textiles, cosmetics down to food.
• The closer the nanoproducts come in their intended use to the human body (surface coatings, textiles, cosmetics, food), the more important it is to include the criterion of “mobilization potential of the public at large”, in the opinion of the experts, in risk assessment.

Source: The German Federal Institute for Risk Assessment (BfR)

New ISO Methodology for the Classification and Categorization of Nanomaterials

Wed, 01 Sep 2010 21:09:02 GMT

Nanomaterials currently in existence exhibit various physical, chemical, mechanical, optical, magnetic and biological properties, as well as different internal/external structures. Because scientists and researchers in this new field have very diverse backgrounds, and are working on different applications, there are now many divergent understandings and assumptions associated with emerging scientific concepts in this area. That not only hampers development but also impedes the type of useful environmental, health, and safety (EHS) research that is necessary.

A clear understanding and a logical classification of nanomaterials is necessary, not only for this technology to develop further, faster and better, but in order to effectively use valid scientific methods to study the toxicity and related safety of the multitude of nanomaterials in use and under development. The lack of uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has important implications for those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk. Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

A further important step towards uniformity is the new ISO technical report, ISO/TR 11360:2010, Nanotechnologies – Methodology for the classification and categorization of nanomaterials, developed by ISO Technical Committee 229 on nanotechnologies. The Technical Report offers a comprehensive, globally harmonized methodology for classifying nanomaterials.

ISO/TR 11360 describes a classifying system, termed a “nano-tree”, which places nanotechnology concepts into a logical context by indicating relationships among them as a branching out tree. The most basic and common elements are defined as the main trunk of the tree, and nanomaterials are then differentiated in terms of structure and different physical, chemical, magnetic and biological properties.

“The document provides users with a structured view of nanotechnology, and facilitates a common understanding of its concepts,” says Peter Hatto, Chair of the committee that developed the standard (ISO/TC 229). “It offers a systematic approach and a commonsensical hierarchy.” Dr. Hatto adds, “The benefits for this emerging field are enormous. Most importantly, ISO/TR 11360 will promote clear and useful communication amongst industry consumers, governments and regulatory bodies”.

The document will be useful to a wide range of scientific and engineering disciplines engaged in research, industry and government.

ISO/TR 11360:2010 is available from ISO national member institutes (ANSI in the United States), or directly from the ISO Central Secretariat through the ISO Store.

Source: ISO

Medical Devices and Nanotechnology -- FDA Public Workshop to Explore Safety and Effectiveness of Medical Devices Utilizing Nanotechnology, September 23, 2010

Wed, 25 Aug 2010 07:31:07 GMT

The FDA Center for Devices and Radiological Health (CDRH) is organizing a public workshop titled "Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations" to be held on September 23, 2010, in Gaithersburg, MD.

There is no registration fee for the public workshop. All parties who are interested in the application of nanotechnology in medical devices are encouraged to register and actively participate in this workshop. Registration and detailed event information relating to this day-long workshop can be found at the following location: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm222591.htm

The FDA’s stated purpose of this workshop is “to obtain information on the safety and effectiveness of medical devices utilizing nanotechnology.” More specifically, FDA “would like public input on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.”

There are two planned sessions for the workshop:

Session I: Manufacturing/characterization of medical devices containing or utilizing nanomaterials or nanostructures
Session II: Biocompatibility/biodistribution/toxicity evaluation for medical devices containing or utilizing nanomaterials or nanostructures

Each session provides three types of participation – expert presentations, an industry/public comments period, and then a round-table discussion. The FDA will select participants for roundtable discussions based on their relevant experience with nanotechnology, and will attempt to have a range of constituencies represented.

For anyone following nanomedicine and related risks and regulatory issues, in particular for devices and products that fall under the auspices of the CDRH, this promises to be an informative event.

Source: FDA

Nanotechnology Safety: Massachusetts OTA Issues Guidance Document for Safe Handling, Use, Disposal of Engineered Nanoparticles

Tue, 24 Aug 2010 09:55:09 GMT

The Massachusetts Office of Technical Assistance & Technology (OTA) recently prepared a Technology Guidance Document, “Nanotechnology – Considerations for Safe Development”

The OTA is a department of the state’s Executive Office of Energy and Environmental Affairs, and is responsible for helping entities in the state achieve superior environmental, health and safety performance while also improving economic sustainability.

According to the Guidance, “there are indications of potential harm from certain exposures and releases of engineered nanoparticles (ENPs), and it is essential to recognize, reduce and control these risks when they are present.” The Guidance was prepared for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment—it will also impede the common interest in realizing the benefits that nanotechnology can provide.”

The Guidance recommends that facilities handling engineered nanoparticles develop a risk-reduction program with the goal of preventing exposure and releases that may cause harm. Topics include (i) “good management practices”; (ii) “preventive materials selection and process design”; (iii) “containment”; (iv) “proper personal protective equipment”; (v) “preventing facility releases”; (vi) “cleanup, storage, transfer”; (vii) “impacts of use and postuse dispositions”; (viii) “labeling”; (ix) “proactive compliance”; and (x) “transparency.” It also contains references to a number of the studies, early standards, and other governmental publication on the potential risks associated with engineered nanoparticles.

Potential tort liability is explicitly recognized by the Guidance:
“Evaluate impacts of use and post-use disposition in order to protect consumers and others, and your organization from potential product, contract, tort, or other liability. Will the use of the product, or its disposal, result in the release of ENPs? Consider that products end up in landfills, incinerators, compacters, can become degraded through exposure to the elements, and can potentially reach all environmental media. Those facing such possible exposures, or faced with cleanup costs, may argue that they had a right to know about the presence of ENPs. Liability is most likely to apply in civil litigation to risks that are reasonably foreseeable. Thinking through the life cycle of the product, and who faces risks of exposure down the line, is a starting point for assessing where disclosure may be advisable. Place yourself in the context of the product recipient and ask, “would I wish to be informed of the presence of this material?” Keeping up to date on the information about potential risks is key to making this judgment. Consider that it is not always information that you know about, but information that you should have known about, that determines the standard to which you may be held.”

This tort-risk admonition tracks the discussion and suggestions made in several of my previous posts. For example, “Reducing Nanotorts in Your Company’s Nanofuture,” Parts 1 and 2.

Nanosilver Safety Debate Continues -- EPA May Give First Approval for Fabrics

Mon, 23 Aug 2010 09:04:53 GMT

"EPA May Give 1st Approval of Nanosilver for Fabrics" is the latest installment in the ongoing AOL News Special Report series about nanotechnology risk. The story addresses news that the EPA may soon issue "conditional approval" to Swiss chemical company HeiQ Materials AG, a producer of nanosized additives, for the use of a nanosilver pesticide as a new active ingredient in fabrics.

The public has been given 45 days (until September 11, 2010) to comment on the EPA's proposal.

The tentative U.S. government approval is new, but the use of a nanosilver in fabrics to make clothing smell better, stay cleaner and destroy germs is not new. Over the past decade clothing manufacturers, mostly from Asia, have been marketing clothing permeated with antimicrobial nanosilver. The AOL News series has reported that socks, underwear, jogging outfits, camping clothing and a long list of other consumer products were being touted as "odor-free" or "germ-proof" because of the use of "the almost magical properties of nanosilver," according to some ads.

But several recent studies show the pass-through of nanosilver in fabrics into the wastewater stream and negative effects on plant and aquatic species. For that reason some health scientists suggest that the nanosilver could cause unknown problems downstream because the safety and health effects of exposure to the antimicrobial nanosilver has yet to be thoroughly tested by anyone, nor blessed by the EPA or the Consumer Product Safety Commission.

The EPA insists that HeiQ Materials AG will be required to conduct a litany of studies before permanent approval is granted. "This conditional registration will allow the manufacturer to produce, market and sell its nanosilver product in the United States under the condition that the manufacturer provide the agency more extensive product chemistry, toxicology, exposure and environmental data," an EPA spokesman told AOL News. The EPA spokesman said the approval in this case, should it be granted, has a four-year expiration date and it is legally binding, which means that if the company doesn't produce the mandated test results, the approval can be pulled. The EPA says it will set a schedule for study submission and will maintain contact with the company to ensure that schedule is met.

But many in the public health community, including some within the EPA itself, do not agree with the use of such conditional approvals, according to the AOL News report. For example, the AOL News report contains the following comments attributed to an “unnamed” EPA toxoicologist/risk assessor: "The granting of conditional approval to these pesticides is the same as giving these chemical companies a 'get out of jail' card. In almost all cases the pending information never shows up, so the potential environmental and health ramifications are really never known. It's the consumer and the workers using these chemicals that face the greatest risk, but the industry pressure on this agency for these approvals is enormous."

A major critic of the EPA's handling of nanosilver to date, The International Center for Technology Assessment (ICTA), was understandably unhappy with the new development. According to The Bureau of National Affairs' Daily Environment Report, Jaydee Hanson, ICTA policy director, denounced the news, arguing that the EPA should have actually pulled existing products made with nanoscale silver off the market and withdrawn their registrations, and sought the data EPA needs to assess their safety from all would-be registrants. "This would be the first product that EPA has approved as a nanoscale silver pesticide. I would have hoped they [EPA] would have tried to get the process as well as the science right," she said, adding that the decision "says because we have so many horses outside the barn already, we might as well let another one out. EPA is not supposed to be the one opening the door."

And the vigorous debate about nanosilver safety continues.

Sources: AOL News, BNA Daily Environment Report

Nanotechnology Risk – Free Webinar “Health and Environmental Challenges and Opportunities,” September 9, 2010

Thu, 19 Aug 2010 10:40:34 GMT

Cantox, an Intertek Company, is hosting a FREE 1 hour webinar on September 9, 2010 at 2 pm EDT, providing an overview of the health and environmental challenges and opportunities of nanotechnology and nanomaterials. This webinar will be followed by a 10 minute interactive Q&A session, allowing registrants to get answers to their concerns.

For those of you hungry for an opportunity to learn more about the current state of nanomaterial risk, in 1 hour at no cost, this looks like a great opportunity.

DATE: Thursday, September 8, 2010
TIME: 2:00 PM EDT / 1:00 PM CDT / 11:00 AM PDT
DURATION: 1 hour
PRESENTER: Bernadene Magnuson, Ph.D.
Senior Scientific & Regulatory Consultant
TO REGISTER: Click Here

Topics to be addressed:
- Fundamental concepts of science, engineering and technology at the nanoscale level
- How to define and describe nanoscale science and nanotechnology
- Current uses of nanomaterials in consumer products
- Factors and properties of nanomaterials that play a role in potential health effects and environmental impact
- Critical factors to consider in assessing safety of nanomaterials
- Solutions to address challenges and be positioned to capitalize on opportunities

Presenter:
Dr. Bernadene Magnuson
Senior Scientific & Regulatory Consultant
Cantox Health Sciences International, an Intertek Company

Dr. Magnuson is a specialist in the developing field of food nanoscience, and has received international recognition for her research on diet and cancer and her work in food toxicology and food safety. Her academic career in food and nutritional science and technology has included teaching and research appointments at the University of Maryland, the University of Idaho, the University of Saskatchewan, and the University of Manitoba. She also has had private-sector experience in Australia, Canada, and the United States.

Dr. Magnuson has been elected to numerous leadership positions of the Institute of Food Technologists – most recently as a member of the Nanotechnology Working Group – and the Society of Toxicology, and she has been the recipient of outstanding service awards from the FDA and IFT. Her research has been published in over 40 peer-reviewed journal articles and book chapters, and had led to several patents. She is a member of the editorial board of the Journal of Food Protection and an associate editor of Food Analytical Methods.

Nanosilver Toxicity: Does it Increase During Product Storage?

Wed, 18 Aug 2010 09:07:54 GMT

The latest development in the ongoing research into toxicity of nanosilver -- already being widely used as a bactericide and antimicrobial in a broad range of consumer and industrial products – will fuel the debate about the safety of nanosilver products. Although scientists have worked to reduce the toxicity of antimicrobial nanosilver in products (Chemists manage to reduce the toxicity of antimicrobial nanosilver in products, 2/24/10), nanosilver safety concerns remain strong, as discussed in a number of my previous Nanotortlaw.com posts.

Not helping to put these concerns to rest is a new study from a group of German researchers that suggests the toxicity of silver nanoparticles increases during storage because of slow dissolution under release of silver ions. The report, “Toxicity of Silver Nanoparticles Increases during Storage Because of Slow Dissolution under Release of Silver Ions,” is published in the American Chemical Society journal Chemistry of Materials, Vol 22, Issue 16 (Aug 24, 2010).

The researchers note that very little is known about the rate of dissolution of silver nanoparticles. "As this rate directly determines the concentration of silver ions in the vicinity of a nanoparticle, it is highly important for any antimicrobial application of silver nanoparticles, and also for assessment of the toxicity of silver nanoparticles in humans," they say. "In addition, the final fate of silver nanoparticles that are released into the environment (e.g., from silver-containing clothes into sewage plants) depends on these data."

The new research suggests that it is likely that the rate of dissolution depends not only on the chemical species (i.e., 'metallic silver in nanoparticulate form') but also on the particle size, the surface functionalization, and the particle crystallinity. In addition, the temperature and the nature of the immersion medium (e.g., the presence of salts or other biomolecules) will be major factors in determning the dissolution rate.

With regard to the toxicity of nanoparticles in the body and in the environment, the biological action of freshly prepared vs. aged nanoparticles is significantly different due to the different amounts of released ions. Unfortunately, the dissolution in a biological medium is much more complicated to measure and describe because of the presence of various compounds in the medium, and the fate of the released silver ions is also unclear. Therefore, the dissolution in pure water, as was done in the experiments of the German research team, gives only some first indications on the fate of immersed silver nanoparticles in biological environments.

What does this mean? This new research suggests that early studies regarding nanosilver may not accurately reflect the ultimate toxicity under real-world conditions where nanosilver-containing products may be stored for some time after manufacture, or for nanosilver products that are intended to have lengthy product lives in use. The study may also provide additional evidence that relying on historical studies related to the health, environmental, and safety of antimicrobial silver is unsound because nanosilver as currently being produced does indeed have unique nanotoxicological characteristics that are still largely unknown.

Sources: Nanowerk Nanotechnology Spotlight, ACS Chemistry of Materials Journal

Nanotoxicity: A Method for Predicting How Nanoparticles Will React in the Human Body?

Tue, 17 Aug 2010 09:40:48 GMT

A team of researchers at North Carolina State University have developed a method for predicting the ways nanoparticles will interact with biological systems, including the human body. Their work could have implications for understanding the potential human and environmental risks associated with nanomaterials, as well as applications for drug delivery.

The study results appear in the Aug. 23 online edition of Nature Nanotechnology, "An index for characterization of nanomaterials in biological systems."

NC State researchers Dr. Jim Riviere, Burroughs Wellcome Distinguished Professor of Pharmacology and director of the university's Center for Chemical Toxicology Research and Pharmacokinetics, Dr. Nancy Monteiro-Riviere, professor of investigative dermatology and toxicology, and Dr. Xin-Rui Xia, research assistant professor of pharmacology, wanted to create a method for the biological characterization of nanoparticles - a screening tool that would allow other scientists to see how various nanoparticles might react when inside the body.

"We wanted to find a good, biologically relevant way to determine how nanomaterials react with cells," Riviere says. "When a nanomaterial enters the human body, it immediately binds to various proteins and amino acids. The molecules a particle binds with will determine where it will go."

This binding process also affects the particle's behavior inside the body. According to Monteiro-Riviere, the amino acids and proteins that coat a nanoparticle change its shape and surface properties, potentially enhancing or reducing characteristics like toxicity or, in medical applications, the particle's ability to deliver drugs to targeted cells.

To create their screening tool, the team utilized a series of chemicals to probe the surfaces of various nanoparticles, using techniques previously developed by Xia. A nanoparticle's size and surface characteristics determine the kinds of materials with which it will bond. Once the size and surface characteristics are known, the researchers can then create "fingerprints" that identify the ways that a particular particle will interact with biological molecules. These fingerprints allow them to predict how that nanoparticle might behave once inside the body.

"This information will allow us to predict where a particular nanomaterial will end up in the human body, and whether or not it will be taken up by certain cells," Riviere adds. "That in turn will give us a better idea of which nanoparticles may be useful for drug delivery, and which ones may be hazardous to humans or the environment."

The Center for Chemical Toxicology Research and Pharmacokinetics is part of NC State's College of Veterinary Medicine. The research was funded by the Environmental Protection Agency and the U.S. Air Force Office of Scientific Research.

Sources: Nanotechnology Now, North Carolina State University

Nano2010 : 5th Annual International Conference on Environmental Effects of Nanoparticles and Nanomaterials to be held at Clemson University, August 22-26, 2010

Fri, 13 Aug 2010 13:10:42 GMT

Clemson University (Clemson, South Carolina) is hosting Nano2010, an international conference of scientists whose research is aimed at understanding how nanotechnology will affect the natural environment. This is the fifth annual international meeting on this topic following the success of previous meetings in the United Kingdom and, most recently, Nano 2009 held in Vienna, Austria.

Nano2010 coordinator Stephen Klaine is a Clemson University professor and Interim Director of the University’s Institute of Environmental Toxicology. As Professor Klaine observed, “[e]ngineered nanoparticles and nanomaterials offer many potential. socioeconomic, health and environmental benefits as a result of novel properties and behavior that materials can exhibit when manufactured at the nanoscale. While the production of nanomaterials is undergoing exponential growth, their biological effects and environmental fate and behavior are relatively unknown.”

Nano 2010 provide a venue for presentation and discussion of the most current research on these issues. The conference brings together an interdisciplinary mix of environmental scientists, toxicologists, material scientists and engineers from five continents, and invited speakers will provide global perspectives on environmental research with nanomaterials.

Sessions will focus on nanoparticle accumulation in the food chain, the impact on microbes, and their fate and behavior in aquatic and terrestrial environments. There also will be poster presentations and discussions.

A special feature of Nano2010 will be a pre-conference short course: Nanomaterials in the Environment, on Aug. 21 and 22. The course is designed to introduce students and faculty members to nanomaterials, review nanoparticle environmental fate and effects, and provide hands-on experience in nanoparticle interaction with life in water environments.

Source: Clemson University, Meridian Nanotechnology & Development News

Reducing Nanotorts in your Company’s Nanofuture : Part 2 of 2

Fri, 16 Jul 2010 10:50:40 GMT

This is the second in a two-part blog article that provides some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

In Part 1, I outlined some of the basic challenges. Here, I outline some specific action plans.

Eight steps for Nanorisk Management right now

1. Carefully audit your insurance portfolio. The potential claim scenarios involving nanotechnology are limitless, but experts expect claims coming in Product Liability, Environmental Liability, Automobile Liability, Workers’ Compensation, and Medical Malpractice insurance products. Review your organization’s existing insurance policy portfolio with insurance coverage counsel to determine whether, and to what extent, nanotechnology-related risks are covered. Standard form commercial general liability (CGL) coverage may not provide coverage for some significant nano-related risks, such as product recalls or mass tort litigation for example. Consider new policies if appropriate. Insurance industry responses to nanotechnology perils range from excluding coverage for nano-risks to developing products tailored specifically to nanotechnology risk. An example is the LexNanoShield insurance product introduced in March 2010, aimed at firms manufacturing nanoparticles or nanomaterials or using such substances in their own products or processes. Nano-facturers should also carefully assess whether their insurance protections fully cover their contractual indemnification obligations or additional insured obligations undertaken in contracts.

2. Audit and inventory your organization's nanotechnology use and content, to identify potential hazards. While the terms “hazard” and “risk” are often used interchangeably, they are not the same. A “hazard” is a property of a product or material that can cause harm. A “risk” is a possibility of harm created by a “hazard,” and is a function of the likelihood of a hazard occurring and the severity of its consequences if it occurs. Because risks are determined by assessment of the likely consequences of identified hazards, thorough hazard identification is the key to the effective management of risk. In the nanotechnology context, comprehensively audit your organization’s use of manufactured nanomaterials – both current and projected. The audit should include all materials and products throughout the supply, manufacturing, distribution, and disposal chain. Nanotechnology is incredibly diverse, and effective EHS hazard and risk assessments cannot take place until you know specifically what nanomaterials are at issue within your organization.

3. Audit and monitor for applicable nanoproduct-related government regulations. The nanotechnology regulatory environment is both evolving and expanding at all levels of government, federal, state, and even local. At the U.S. federal level alone, a virtual alphabet soup of agencies and departments have jurisdiction over aspects of nanomaterials. To name just a few: EPA, FDA, OSHA, NIOSH, and CPSC. And aspects of a number of important statutes apply to nanomaterials. To name just a few: TSCA (Toxic Substances Control Act), FHSA (Federal Hazardous Substances Act), OSHA (Occupational Safety and Health Act), NEPA (National Environmental Protection Act), FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act), and FDCA (Food, Drug and Cosmetic Act). For organizations doing business internationally the task is substantially more complex. For example, the provisions of European chemicals legislation REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) apply to nanoscale substances, requiring the full range of REACH registration and risk assessment. Finally, larger international frameworks concerning nanomaterial EHS are also under development and should be closely watched, such as the recent focus on the risks of nanomaterials by the Strategic Approach to International Chemicals Management (SAICM), under the auspices of the World Health Organization (WHO), United Nations Environment Programme (UNEP), and others. Perform a thorough search for the universe of regulations applicable to your organization’s nanotechnology and monitor rulemaking in progress; there are new regulatory and rulemaking developments almost monthly in this nascent field.

4. Audit and monitor for applicable workplace and employee health and safety regulations and best practices. Carefully audit the applicability of federal OSHA, state OSHA, and local workplace safety regulations. The National Institute of Occupational Safety and Health (NIOSH) is significantly involved in studying the potential health and safety impacts of nanotechnology in the workplace (as are similar workplace safety agencies in the EU countries and Australasia). The earliest and most extensive exposures to manufactured nanoparticles are likely to occur in the workplace. Your employees, contractors, and others may be exposed to nanomaterials during the manufacturing, end use, disposal, or recycling of nanomaterial-containing products. Regulations and industry best practices concerning hazardous materials handling, hazard communications (including labels and MSDSs), and personal protective equipment will apply. Workplace nano-safety best practices are available from several sources, including the “GoodNanoGuide,” sponsored by NIOSH, Industry Canada, and the International Council on Nanotechnology (ICON).

5. Assess your organization's compliance with design, testing, manufacturing, and warning industry standards and best practices. Compliance with government regulations is not the end of the legal obligation for organizations seeking to manage nanotechnology legal risk. They are simply the “end of the beginning.” In the tort litigation context, industry standards and best practices are the minimum standard of care to which your organization is likely to be held. It is imperative that you stay up to date on the state-of-the-art concerning EHS research and best practices within your organization’s industry or field. Existing industry standards may also be inadequate given the unique physical and chemical properties of nanomaterials. Nano-facturers will need to be proactive, vigilant and flexible in tracking, assessing and implementing best practices that affect nanomaterial risks. Early nanomaterial stewardship and risk mitigation best practices are available from several sources, including the “Nano Risk Framework,” created by DuPont and the Environmental Defense Fund.

6. Review and modify supplier (upstream) and customer (downstream) contracts to deal with nanotechnology risk. Many purchase orders and other contracts governing your organization’s liabilities vis-à-vis others in the chain of manufacturing, distribution, and handling of nanomaterials may need to be modified and updated. Appropriate indemnification and risk sharing provisions are important. Additional insurance endorsements and additional insured requirements may be warranted. Instructions on methods of safe handling and disposal may be worthwhile to consider. As noted above, be sure your insurance coverage extends to any contractual provisions such as indemnity and additional insured obligations that are undertaken.

7. Identify and address post-manufacturing issues. Liability can arise from packaging, including labeling, as well as transportation, shipping and handling. Special packaging, special handling instructions, and even new warnings and hazard symbols may be necessary. What about the security, maintenance or repair of nanomaterial-containing products? Special training and education of those who may secure, maintain, or repair those products, and an evaluation of the potential health risks to those persons, will be required. Safe disposal is also a concern. Instructions on safe disposal, assessment of potential environmental risks, and evaluation of potential EHS risks of product waste transport are all necessary.

8. Put together your nanorisk team, now. Nanotechnologies are diverse and complex. Nano-related hazards and nano-related risks will be diverse and complex. Assessing the legal risk associated with your organization’s nanotech footprint and compliance is a specialized field, both legally and scientifically. Your attorneys in this area must understand the fast-moving science, the ongoing EHS research being conducted worldwide, and the evolving governmental regulations, industry standards and accepted best practices associated with the specific nanomaterials at issue within your organization.

Nano-specific technical expertise that will be needed includes experts in fields such as nanotoxicology, biostatistics and epidemiology, industrial hygiene, human health risk assessment, and ecological risk assessment.

The time to cultivate these relationships is now, before the first summons and complaint is served on your organization. Waiting until nanotechnology-related lawsuits are already filed to start the search for expert nanotort litigation counsel and technical experts is probably too late.

Vigilance = Nanorisk Reduction

Legal and insurance professionals whose clients are manufacturing, importing, selling, or disposing of nanomaterials – at any stage of the lifecycle – face a daunting task. Nanotechnology risk assessment and litigation are not areas for dabbling. Perhaps more than any other existing area of tort and environmental law, knowledge of continuous, real-time developments in science, HES research, and government regulations will be needed to provide competent legal and risk assessments, and to defend against inevitable claims. But Nano-facturers that are vigilant and proactive will thrive in spite of the risk.

Reducing Nanotorts in your Company’s Nanofuture : Part 1 of 2

Mon, 12 Jul 2010 13:26:01 GMT

Over the past two years I have written extensively about some of the potential litigation risks posed by exposure to nanoparticles, and on the evolving response of U.S. government agencies to regulation of nanotechnologies.

This two-part blog article takes the next step and aims to provide some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

Nanotort litigation is drawing nigh

“The Rise of Nanotech Litigation.” So reads the cover of the Winter 2010 issue of Litigation News, the magazine of the ABA Section of Litigation.

“Nanotechnology: Brave New World for Civil Tort Plaintiffs.” So reads the title of a recent article in The SciTech Lawyer, the magazine of the ABA Section of Science & Technology Law.

It is not just lawyers who foresee a potential flood of new tort claims.
- “EU Ministers Call for Nanomaterial Ban,” Chemistry World, June 2010
- “Nanosilver has No Place in Food, Textiles, or Cosmetics,” German Federal Institute for Risk Assessment, June 2010.
- “A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.” AOL News Special Report series, The Nanotech Gamble: Bold Science, Big Money, Growing Risks, March 2010
- “Nanoparticles – one word: A multiplicity of different hazards,” Nanotoxicology, December 2009
- “Nanotechnology: The Next Battleground for Mass Torts,” BNA Toxics Law Reporter, December 2009
- “Nanotechnology could possibly translate into mega risks.” Tiny Objects, Big Concerns: Managing Nanotechnology Risks, Claims Magazine, December 2009

How concerned should you be?

Little is yet known about the acute or chronic toxicity of nanoparticles in general or the effects of various particle-specific characteristics. Although tentative, some early studies suggest that some specific nanoparticles already in widespread use (e.g., carbon nanotubes, nanosilver, nanoTiO2, and nanoZnO) may have the potential to cause negative health and environmental consequences. It is unknown whether some engineered nanoparticles are simply toxicants under some dose/exposure circumstances, or whether they may also be carcinogens, teratogens, or mutagens. It will take many years for studies about exposure routes, the effects on human health, and effects on the environment to reach what may be viewed as conclusive results. Meanwhile, nanoparticle-containing products are already being manufactured, sold, and disposed of at both the industrial and consumer levels, with dramatic growth.

In addition to toxic exposure and environmental hazards, nanoparticles can present a fire and explosion hazard. Explosive dust clouds can be generated from a wide range of organic, inorganic, and metallic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust cloud is the particle size or specific surface area, which means that, generally, the violence of the dust explosion and the ease of ignition will increase as particle size decreases. An increasing range of materials that are capable of producing explosive dust clouds are being produced as nanopowders. Those risks need to be evaluated throughout the manufacturing and distribution processes. A presentation at the American Society of Safety Engineers annual conference in June 2010, “Nanotechnolog-E: Explosivity and Environmental Risks,” observed that there is still virtually no existing data relating to fire and explosion hazards of nanoparticles.

Looking into the nanotorts litigation crystal ball

My most recent search of federal and state court dockets and opinion databases found no pending lawsuits alleging nanotechnology exposure. But legal experts agree that nanotechnology tort litigation is not far off. It has been a fact of American law that new technology breeds new litigation. Experience also teaches that when there are concerns about possible health and safety hazards, tort litigation is not far behind. The question is not so much if, but when, nanotort claims and litigation will arise. When nanotort claims are made, they can be expected to cover the full range of tort litigation: product liability, both individual and efforts at mass tort/class action; medical monitoring; workers’ compensation; environmental contamination/cleanup; and property damage.

The common law of torts requires product manufacturers, chemical manufacturers, and commercial users [collectively “Nano-facturers”], to be knowledgeable experts about the hazards and risks of their products and to test and warn in a manner commensurate with the product use and the known or knowable environmental, health, and safety (EHS) information. For that reason, Nano-facturers must remain continuously aware of ongoing developments in nanomaterial hazard and risk assessment as well as nanomaterial EHS information.

Are you and your company or clients adequately prepared?

Action to recognize, mitigate, and manage risk from nanotechnologies is clearly warranted. But what concrete steps should you be taking? In the second half of this blog article, I will briefly outline 8 steps for nanorisk management right now.

NanoBusiness Alliance issues commitment to managing the environmental, health, and safety (EHS) implications of nanotechnology

Fri, 02 Jul 2010 10:01:04 GMT

On July 1, 2010, the NanoBusiness Alliance issued a “Position Statement on Nanomaterials Product Sustainability,” which reflects NanoBusiness Alliance members’ commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.

“The NanoBusiness Alliance is committed to being the leader in the sustainable development of nanomaterials around the world," said Vincent Caprio, President of the NanoBusiness Alliance. "We are committed to working with governments and nanomaterials stakeholders to manage the sustainable development and use of nanomaterials in a responsible way."

The NanoBusiness Alliance has long advocated on a wide variety of business issues pertinent to the development and commercialization of nanomaterials and nano-enabled products, including securing funding for nano enterprises, the elimination of trade barriers, and encouraging and supporting nano innovations and their successful transition from research into sustainable commercial enterprises that create jobs and revitalize the U.S. economy. Recognizing that successfully managing EHS issues is an essential component of the commercialization of nano innovations, the NanoBusiness Alliance has redoubled its commitment to and its focus on these EHS issues.

“The NanoBusiness Alliance has consistently supported its members’ commitment to EHS excellence and our Position Statement embodies this long-standing commitment. The NanoBusiness Alliance will continue its leadership in this essential area.”

Position Statement on Nanomaterial Product Sustainability
As an enabling technology applicable to diverse fields, including alternative energy, medicine, and electronics, among many others, nanotechnology offers tremendous value to society. As with any emerging technology, nanotechnology and nanoscale materials must be managed in a responsible way to identify and minimize any potential adverse effect on human health or the environment. The Alliance is committed to fostering the responsible and sustainable development of nanotechnology, to working with governmental and related nanotechnology stakeholders to develop appropriate scientific testing tools, methodologies and data to characterize nanoscale materials, and to developing informed, science-based governance policies, laws, standards, practices, and regulations pertinent to nanoscale materials.

About the NanoBusiness Alliance
The NanoBusiness Alliance is the industry association for the emerging nanotechnology industry. Through its extensive network of leading startups, Fortune 500 companies, research institutes, non-governmental organizations, and public-private partnerships, the NanoBusiness Alliance aims to shape nanotechnology policy and help accelerate the commercialization of nanotechnology innovations. The NanoBusiness Alliance has offices in New York, Chicago, Washington, D.C., and Connecticut. For more information, visit http://www.nanobusiness.org.

Diesel exhaust nanoparticulates: what do DEP human clinical studies tell us about potential human health hazards of engineered nanoparticles?

Thu, 01 Jul 2010 16:14:06 GMT

Engineered nanoparticles (ENPs) are increasingly being tested in cellular and laboratory-animal experiments for hazard potential, but there is a lack of health effects data for humans exposed to ENPs. However, human data for another source of nanoparticle (NP) exposure are readily available, notably for the NPs contained in diesel exhaust particulate (DEP).

Researchers in the United States recently conducted a review of human data from clinical trials using Diesel Exhaust Particles (DEP) in an attempt to draw conclusions for the potential health hazards that could arise from exposure to ENPs.

The research findings show that in recent human diesel exhaust (DE) exposure studies, elevated DE exposures from pre-2007 engines can trigger short-term changes in lung and systemic inflammation, thrombogenesis, vascular function, and brain activity. Considerable uncertainty remains as to which DE constituents underlie the observed responses (i.e., DEP NPs, DEP mass, DE gases) , and the DE human clinical data do not give evidence of a unique toxicity for NPs as compared to other small particles. Of course, physicochemical properties of toxicological relevance may differ between DEP NPs and other NPs, in particular ENPs already in widespread use, such as various high-aspect ratio nanoparticles (e.g., carbon nanotubes) and metal oxide nanoparticles (e.g., zinc oxide, titanium oxide).

Overall, the study authors concluded that "the DE human clinical data do not support the idea that elevated levels of NPs per se (at least in the DEP context) must be acutely toxic by virtue of their nano-sized nature alone."

The study is published in the July 2010 issue of the journal Inhalation Toxicology (Vol. 22, No. 8, Pages 679-694), “Diesel exhaust particulate (DEP) and nanoparticle exposures: What do DEP human clinical studies tell us about potential human health hazards of nanoparticles?”

Authors include:
Thomas W. Hesterberg 1, Christopher M. Long 2, Charles A. Lapin 3, Ali K. Hamade 2, Peter A. Valberg 2
1Navistar, Inc., Chicago, Illinois, USA
2Gradient, Cambridge, Massachusetts, USA
3Lapin & Associates, Glendale, California, USA

The abstract, and a link to the full article, can be viewed online at the link below.
http://informahealthcare.com/doi/abs/10.3109/08958371003758823?journalCode=iht

Sources: Informa Health Care, Inhalation Toxicology, Meridian Nanotechnology & Development News

New GAO Report urges EPA to speed up efforts to research and effectively regulate nanomaterial risk

Wed, 30 Jun 2010 08:32:57 GMT

The call for a greater sense of urgency by government was reiterated again on June 25, 2010. A new report issued that date by the United States Government Accountability Office (GAO), "Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk," says that the U.S. Environmental Protection Agency (EPA) needs to expand its efforts to obtain health, environmental, and safety information about nanomaterials and effectively regulate them. The GAO report was requested by the Senate Committee on Environment and Public Works.

This is a familiar refrain, not only from special interest groups that have been pressing EPA for several years on this issue, but also from within various quarters of the government. In March 2010 the President's Council of Advisors on Science and Technology (PCAST) – the top U.S. science advisors – issued a report that urged EPA and other agencies to significantly increase and improve their research and inter-agency collaboration on environmental, health, and safety questions arising from various applications of nanotechnologies.

The GAO said, in the recent report, that "the use of nanomaterials in products is growing faster than our understanding of the risks these materials pose to human health and the environment. While EPA has taken steps to improve our understanding of these risks, such as by asking companies to voluntarily provide information on the nanomaterials they produce, the information gathered through these efforts has been limited and does not provide a strong foundation for understanding the increasing potential for exposure to these materials as they become more prevalent."

The GAO report called on the EPA to proceed with previously announced plans to increase the information the agency has on nanomaterials and expand its oversight of them, and said the EPA should update the Federal Insecticide, Fungicide, and Rodenticide Act regulations to require the identification of nanomaterial ingredients in pesticides. The EPA should also make greater use of other regulatory authorities, such as the Clean Water Act, to collect more information about nanomaterials.

The EPA, in response, said it agreed and concurred with the GAO recommendations.

Now what? I expect that we will see a number of initiatives and announcements from the EPA over the next several months, in particular on the FIFRA/regulations front, where concerns about nanosilver in particular have been ongoing. Stay tuned.

Sources: The Bureau of National Affairs' Daily Environment Report, Meridian Nanotechnology & Development News

Nanotechnology Safety @ American Society of Safety Engineers “Safety 2010”

Fri, 25 Jun 2010 14:15:17 GMT

The ASSE’s annual conference, “Safety 2010,” held on June 13-16 in Baltimore, included two presentations about aspects of nanotechnology risk and safety.

1. Nanomaterials: The Good, The Bad and The Ugly
(Leslie C. Caskey, Christopher W. Kolbash)

2. Nanotechnolog-E: Explosivity and Environmental Risks
(Louise E. Vallee, Julia C. Bradley, Erik G. Olsen)

If you are interested, these presentations are available for purchase from the ASSE website. http://www.asse.org/education/pdc10/

I briefly summarize the first presentation below.

Nanomaterials: The Good, the Bad and the Ugly

In this presentation, Celeste Caskey, CSP, and Christopher Kolbash, CIH, AOEE, of the Center for Nanotechnology and Molecular Materials, Wake Forest University, repeated the conventional wisdom and projections that nanotechnology will likely be in full swing by 2015 and generate $1 trillion in global commerce.

The Good
“The good news about the nanotechnology revolution is that nanomaterial usage is broad in range,” said Caskey. Nanomaterials are being used in molecular switches, solar cells, textiles, electronics, appliances, sporting goods, automobiles, sunscreens, cosmetics, food/beverages and much more.

Biomedical applications include drug carriers, tumor imaging, cell-targeted therapy, wound dressing, cell sensors/microchips, implants and other devices, cell and tissue scaffolds, among others.

But the small size and surface area that make nanomaterials so useful also makes them more reactive and possibly more toxic.

The Bad
Kolbash pointed out that nanomaterials may be able to penetrate cellular membranes. They are respirable, so they can be inhaled deep into the lungs and then likely pass into the bloodstream. Some nanomaterials also seem to be able to migrate through the skin.

Typical approaches to protect workers and the environment from hazardous substances includes using PPE, regulations, engineering controls, toxicological data and administrative controls. The dilemma with nanomaterials, Kolbash said, is the uncertainty surrounding them: Which PPE should researchers use? Will there be specific regulations for nanomaterials in the future? Can fume hoods sufficiently contain nanomaterials? What toxicological data should be used? “It’s ever-changing,” Kolbash said. “You find new information out all the time.”

The University’s chemical safety committee released a nonmaterial protocol in the fall of 2008, but many committee members and environment, health and safety staff lacked the expertise to review the protocol. So they created a subcommittee to develop guidelines. The resulting charter set out to “use the best available science to make interim recommendations for workplace safety, health and environmental practices during the use, handling and disposal of nanomaterials.”

Wake Forest researchers developed a color-coded risk communication system that grouped nanomaterials in the following 4 risk categories:
Level 1 – These nanomaterials have been determined to present little or no hazard
Level 2 – For nanomaterials suspended in liquid or matrix. This requires a base level of PPE and work must be done in a fume hood or biosafety cabinet, not on a bench top.
Level 3 – For dry nanomaterial use or when limited hazard information is known. Researchers must use a hard-ducted biosafety cabinet, double nitrile gloves and, for dry nanomaterials, non-woven lab coats.
Level 4 – Nanomaterials at this level are suspected to present a substantial personal or environmental hazard. PPE would include an N95 or N91 respirator.

The Ugly
“The ugly is really the unknown,” Kolbash said. “There’s a lot of other questions we haven’t gotten to addressing yet.”

Lots of partially answered and lots of unanswered questions is right. Let's hope that more concrete EHS information and related risk management guidance can be offered at "Safety 2011" in Chicago. ASSE will commemorate its 100-year anniversary in 2011 and the Society’s 100th year theme is “Your Safety Is Our Business. Your Future Our Mission.” An even broader discussion of nanotechnology-related safety would certainly fit that theme.

Sources: The American Society of Safety Engineers, EHS Today (the magazine for environmental, health, and safety leaders, available at http://ehstoday.com/)

Are Nanoparticles in Sunscreens Safe? Friends of the Earth says “Nano should be a no-no”

Fri, 18 Jun 2010 10:37:08 GMT

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.

FoE claims that scientific research already completed indicates that nanomaterials used in sunscreens (such as zinc oxide and titanium 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.

FoE is calling on sunscreen manufacturers to avoid using manufactured nanoparticles in sunscreens, and is calling on U.S. federal officials to require that sunscreens containing manufactured nanoparticles be labeled as such.

Consumers do have the option of avoiding nanoparticles in their suncreens.
FoE Australia publishes a “Safe Sunscreen Guide,” recently updated for 2010.

The Environmental Working Group (EWG), an environmental health non-profit, also has prepared a list of recommended sunscreens, available at the EWG website, at www.ewg.org/cosmetics/report/sunscreen09/Beach-Sunscreens.

In 2006, Friends of the Earth released its initial report, “Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks.”

Since then FoE has released updated reports every year, sharing more and more about what FoE describes as “alarming risks, which could affect consumers, workers, and the environment.”

These include:
“Manufactured Nanomaterials and Sunscreens: Top Reasons for Precaution”

and

“Nanotechnology and Sunscreens”

What to make of this?
There clearly is a vigorous, and genuine, debate about whether the widespread use of nanomaterials in sunscreens and other cosmetics is safe for humans and the enviroment. In 2006 a citizen’s petition was made to the FDA to take a greater role in regulating the use of nanoparticles in sunscreens. In general, the FDA does not regulate skin care products because they are topical and systemic effects are determined to be low. In response, the FDA convened a Nanotechnology task force that recommended the FDA work with other federal agencies and private groups to increase general scientific knowledge and facilitate assessment of information to set safety standards for sunscreens. An additional plan to provide more specific labeling for sunscreens has not yet been carried out by the FDA.

Who is FoE?
Friends of the Earth U.S. is a part of Friends of the Earth International, which bills itself as the world's largest grassroots environmental network. Friends of the Earth International unites 77 national member groups and some 5,000 local activist groups on every continent. To learn more, click here. http://foe.org/who-we-are

Sources: Friends of the Earth, Meridian Nanotechnology & Development News

Nanofood II : If you are really interested in food safety and related risk . . .

Thu, 17 Jun 2010 17:42:41 GMT

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:

1. Nanotechnologies in Food (RSC Nanoscience and Nanotechnology)
Qasim Chaudhry, Laurence Castle, Richard Watkins (Editors)
Publisher: Royal Society of Chemistry; (May 6, 2010), Hardcover: 300 pages

This book provides a source of much needed and up-to-date information on the products and applications of nanotechnology for the food sector - for scientists, regulators, and consumers alike. It also gives an independent, balanced, and impartial view of the potential benefits as well as risks that nanotechnology applications may bring to the food sector.

Despite the rapid developments in nanotechnology applications for the food sector, prior to this book only a few reports and articles were available that provide an account of the new developments and the current size of market for nanotechnology products and applications. These do not provide a critical evaluation of the broader aspects of the technology, such as issues around safety of the products to consumers and the environment, and adequacy of the existing regulatory controls.

About the Authors
Dr. Chaudhry is a Principal Research Scientist at the Food and Environment Research Agency (Fera) of the UK's Department for Environment, Food and Rural Affairs. He is also a member of the European Commission's Scientific Committee on Consumer Safety (SCCS), and a Visiting Professor at the University of Chester. Dr. Chaudhry is a Chemist and Biochemical Toxicologist by training. He currently leads a team of scientists at Fera who are undertaking research into the safety of nanomaterials to human health and the environment in a variety of products and applications, including food and food packaging. Dr. Chaudhry has published a number of research papers, review articles, and study reports on a range of safety and regulatory aspects of nanotechnologies.

Dr. Castle is a Principal Scientist in the Contaminants and Authenticity group at Fera. He and his co-workers have published more than 150 refereed journal papers dealing with chemical analysis of food additives and contaminants. Dr. Castle is an independent member of the CEF panel (contact materials, enzymes and flavourings) of the European Food Safety Authority and he was a member of the predecessor panel and working groups since 1996. He also has extensive experience working in other national and international risk assessment and standardization groups including JECFA, WHO, DG-SANCO, CEN. CoE etc.

Dr. Watkins is Head of Environmental Risk Programme at the Food and Environment Research Agency (Fera). He leads a number of scientific teams that provide research and consultancy in risk management systems to assess and mitigate against the risks posed by conventional and emergent environmental contaminants (including nanomaterials). Dr. Watkins is author of over 40 peer-reviewed articles including two recent book chapters on food contaminants and the regulation for nanomaterials.

2. Nanotechnology in Food Products: Workshop Summary
Food Forum (Author), Institute of Medicine (Author), Leslie Pray (Editor), Ann Yaktine (Editor)
Publisher: National Academies Press (October 21, 2009), Paperback: 146 pages

The National Academy of Science’s Institute of Medicine held a one-day workshop, summarized in this volume, to further explore the use of nanotechnology in food. Ten world-renowned authorities on food nanotechnology gave presentations, after which participants discussed three primary topics: (1) the application of nanotechnology to food products; (2) the safety and efficacy of nanomaterials in food products; and (3) educating and informing consumers about the applications of nanotechnology to food products.

The IOM notes that nanotechnologies provide scientists with the ability to enhance food safety and make foods more nutritious and satisfying by enhancing their nutrition content and other characteristics. However, researchers still have much to learn about the result of using nanotechnology to create food packaging or to modify a food, including both benefits and unanticipated adverse effects.

Sources: Royal Society of Chemistry, Institute of Medicine, National Academy of Sciences

NSTI Nanotech 2010 : Nanotechnology, Health and the Environment

Mon, 14 Jun 2010 12:07:38 GMT

A report titled "Nanotechnology, Health and the Environment" will be presented at the Nano Science and Technology Institute's (NSTI) “Nanotech Conference & Expo 2010” in Anaheim, CA, June 21-24, 2010.

The report is available for download at Nanotechnology - Greenberg Traurig, LLP.

The report is authored by Chinh H. Pham, Chair of law firm Greenberg Traurig's Nanotechnology Practice; Reed D. Rubinstein, Shareholder in the Environmental and Administrative Law Practice at Greenberg Traurig in Washington, D.C.; Dr. Richard C. Pleus, Managing Director of Intertox; and Lynn Foster, CEO of BPT Pharmaceuticals, who was previously at Greenberg Traurig. The report acknowledges that EHS risks of nanotechnology require additional study but suggests that initial indications are that these risks are generally remote, speculative, and manageable.

About Intertox, Inc.
Intertox is a scientific consulting and research firm passionate about achieving long-term solutions that protect public health. Headquartered in Seattle, WA, Intertox has been working in the nanomaterial industry to develop global health-protective standards and implementation practices. Intertox and Intertox's sister company, Intertox Decision Sciences, provide analytical services and business risk assessments that both characterize and minimize nanomaterial risks. For additional information, visit the firm's website at http://www.intertox.com.

Source: NSTI and Nanotechnology Now

NIOSH Conference July 2010: Nanomaterials and Worker Health

Thu, 10 Jun 2010 17:40:17 GMT

The National Institute for Occupational Safety and Health (NIOSH) and the Mountain and Plains Education and Research Center will hold a conference on "Nanomaterials and Worker Health: Medical Surveillance, Exposure Registries, and Epidemiologic Research."

The conference will be held on July 21–23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado.

NIOSH, part of CDC, is the federal agency legislatively established under the Occupational Safety and Health Act of 1970 that conducts research to prevent work-related injury, illness, and death. NIOSH has been perhaps more active than any other U.S. federal agency so far in nanoparticle EHS research and I discuss the body of information available from NIOSH concerning whether nanomaterials pose risks for occupational illness at my earlier post, NIOSH Nanotechnology Health & Safety Update: Updated, Enhanced Web Resources Posted 12/8/09.

The aim of the conference is to identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers. In each of these areas, the conference promises to:
- Share existing knowledge
- Identify major issues
- Examine successful approaches
- Explore new approaches, techniques, and models.

NIOSH says the conference will enable members of the occupational safety and health community concerned with nanomaterials and the health of workers exposed to these materials to address fundamental questions and seek practical solutions for carrying out occupational health surveillance, developing exposure registries, and conducting epidemiological research.

The conference will include invited and submitted papers, breakout sessions to allow for small group discussions, and poster presentation.

I expect that some worthwhile information and written materials will become publicly available following the conference. Stay tuned.

New “NanoSafety Consortium for Carbon” formed to address nanoscale carbon EHS issues

Wed, 09 Jun 2010 11:32:13 GMT

Carbon nanotubes and other carbon nanomaterials are now, and are expected to remain, the most commonly used nanomaterial in industrial applications. They are also used in a wide variety of consumer products and that trend is expected to continue. Early research has already raised questions, if not concerns, about the environmental, health, and safety risks of some carbon nanomaterials, such as single-and multi-walled carbon nanotubes.

Twelve (12) leading companies involved in the commercialization of carbon nanomaterials and products recently formed the NanoSafety Consortium for Carbon ("NCC") to address nanoscale carbon environmental, health, and safety issues related to the responsible commercialization of their products.

The NCC website is designed to inform the public about its activities.

For example:

NCC Purpose: To address global legal, regulatory, environmental, health, and safety (“EHS”) issues related to the responsible commercialization of its members’ nano-related products. NCC may conduct or sponsor such EHS research projects as approved by NCC's Management Committee, and may also take all steps necessary to advance NCC's positions on EHS issues related to carbon nanomaterials.

NCC Objectives:

- Pursue the potential development of a mutually agreeable testing regime between NCC and US EPA for a suite of representative carbon nanomaterials to fulfill the toxicity testing requirements of any TSCA consent order applicable to NCC's members' existing carbon nanomaterials.

- As part of any overall representative testing regime, develop a mutually agreeable approach between NCC and US EPA which allows a reasonable range of modification to members’ products without requiring renewed comprehensive toxicity testing.

- Provide EPA with NCC's perspective on the scope of any data-call-ins or testing rules which might be issued for carbon nanomaterials under Sections 4 or 8 of TSCA.

NCC Advisory Board
The impressive NCC Scientific Advisory Board consists of a number of well-respected scientists in the field of nanotechnology risk assessment, including Dr. Vince Castranova, Chief of the Pathology and Physiology Research Branch, NIOSH Health Effects Laboratory Division; Dr. Charles Geraci, Coordinator of the NIOSH Nanotechnology Research Center (responsible for the development of workplace guidelines, including the NIOSH document “Approaches to Safe Nanotechnology”); Dr. Bettye L. (Smith) Maddux, a U.S. Delegate on the American National Standards Institute (ANSI) US Technical Advisory Group (TAG) to the International Organization on Standardization’s (ISO) Technical Committee (TC) on Nanotechnologies 229; Jeff Morse, Managing Director of the National Nanomanufacturing Network and previously a Senior Scientist in the Center for Micro and Nano Technology at Lawrence Livermore National Laboratory; and Dr. Günter Oberdörster, Professor of Environmental Medicine at the University of Rochester and a well-known and influential nanoparticle research scientist.

Membership: Membership in NCC is open to any business entity actively pursuing the commercialization of carbon nanomaterials or products.

For non-members, a resource at the NCC site is its up-to-date In Vivo Toxicology Bibliography for Nanoscale Carbon, containing references and abstracts to relevant research from 1990 to the present.

Check it out.

Nanofood & Agriculture : If You Are Really Interested in Food Safety and Related Risk . . .

Thu, 03 Jun 2010 10:02:30 GMT

. . . then you simply must start becoming knowledgeable, if not expert, on the uses of nanotechnology in agriculture and food production, food products, food processing, and food packaging. It is going to be a significant growth area and an expected litigation field within the food safety/toxic exposure arena.

I'd suggest you might do a couple things to get started:

1. Check out the Food Processing magazine article, "Nanotechnology Coming to Your Store," available on-line at http://www.foodprocessing.com/articles/2009/066.html(written by yours truly).

2. Check out the recent New Scientist magazine article, "The Taste of Tiny: Putting Nanofoods on the Menu," available on-line at http://www.newscientist.com/article/mg20627611.100-the-taste-of-tiny-putting-nanofoods-on-the-menu.html?full=true#bx276111B1

3. Check out a recent survey at the IFIC (Int'l Food Information Council) site, and sign up for the free on-line monthly IFIC newsletter while you are there.
http://www.foodinsight.org/Press-Release/Detail.aspx?topic=Interest_in_Environment_Sustainability_Prevails_in_Food_Technology_Survey

4. Check out the recent United States Government Accountability Office (GAO) report, "Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS)", where the GAO finds that the U.S. Food and Drug Administration (FDA) does not exercise adequate oversight over nanomaterials entering the food supply. In contrast to FDA's approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed. The report is found at http://www.gao.gov/products/GAO-10-246

5. Check out the recent European Union (EU) Parliament's Environment Committee decision that food produced using nanotechnology should be excluded from the EU's list of novel foods - foods not on the market before May 1997 - thereby prohibiting foods containing nanomaterials from being sold on the EU market. And that foods produced using nanotechnology should undergo specific risk assessment, with possible health effects determined, before being put on the European market. See that at
http://www.europarl.europa.eu/news/public/story_page/067-74271-127-05-19-911-20100507STO74257-2010-07-05-2010/default_en.htm

6. For a thorough exposition of the "anti-nanotechnology in food" position, warning of nanofood dangers, see a lengthy position paper by Friends of the Earth, "Out of the Laboratory and On To Our Plates," (see report cover page above) available on-line at http://www.foe.org.au/nano-tech/media/news-items/front-page-news-feed-1/no-labels-no-safety-testing-2013-our-new-report-reveals-high-tech-nanofoods-pose-toxic-risks-97-friends-of-the-earth-australia/?searchterm=nano

A few other interesting nanofood tidbits . . .

Nanotoxicology 2010 - June 2-4, 2010 (Edinburgh, Scotland)

Tue, 01 Jun 2010 14:16:39 GMT

“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).

Each section will include talks spanning disciplines including exposure assessment, characterization, human toxicology, ecotoxicology and risk assessment.

The titles of a few of the presentations are shown below, to give you an idea of the breadth and depth of the conference and its leading-edge subjects:

Session 1: Setting the scene
Keynote: Nano-Particles and Mega-Doses: Relevant for Identifying Adverse Effects

The European Commission’s Strategy for Nanotechnology Human and Environmental Safety Research

Session 2: Metals
Keynote: Characterization of Inorganic Nanoparticles for Environmental Fate and Effects Studies

Definition, identification and biophysical interactions of nanomaterials

Session 3: High aspect ratio nanoparticles [e.g., carbon nanotubes]
Keynote: Asbestos-like effects of HARN (high aspect ratio nanomaterials) in the pleural cavity: approaching an understanding

Biodegradation of carbon nanotubes in the environment and in vivo

Session 4: Metal Oxides
Keynote: Metal Oxide Nanoparticles: Lessons from the Past and Questions for the Future

Nanomaterial Exposure Measurements and Monitoring for Risk Assessment

Session 5: Fate
Keynote: Particle metrics and health - results from an epidemiological study in London

Accumulation and translocation of nanomaterials across the human placenta

The biodistribution, persistence, and toxicity of nanoscale ceria

Toxicity of carbon nanotubes to the lung: from mechanisms to regulatory consequences

Session 6: New and Emerging Topics
Keynote: Nanotoxicology? You ain't seen nothing yet! The challenges of developing emerging technologies responsibly

Regulating uncertainty – Performance based benchmark limits for nanoparticles in view of current measurement results at the work place

Session 8 : Environmental Issues
The ecotoxicity of four nanomaterials – The ENRHES review [ENRHES is the Engineered Nanoparticles - Review of Health & Environmental Safety project of the European Commission]

OECD test guidelines and regulatory testing of nanomaterials

Session 9 : Mixed Session
Nanotechnology environmental health and safety research at NIEHS

Occupational risk assessment of multi walled carbon nanotubes

Toxic effects of nanoparticles and nanoparticle-containing paint dust on the cardiovascular system

Stay tuned. This is an exciting and important conference and for those of us who cannot travel to Edinburgh, there will no doubt be follow-up information and copies of some of the presentations that become publicly available.

Report: "Canadian Media admits to nanotechnology risks"

Mon, 31 May 2010 07:39:49 GMT

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.”

Despite the relative lack of research, the report recognizes the reality that there are already hundreds of nanoparticle-enhanced products already on the market and it is only a matter of time before nanotechnology is an inescapable part of everyday life. The Consumer’s Council of Canada suggests that consumers minimize the unknown risks of nanoparticles by at least staying away from nanotechnology products aimed at children, such as anti-bacterial baby bottles and stain-resistant plush toys.

The report concludes: “There are some concerns about toxicity. We don’t know what happens to these particles once they make their way into the body. There are possibilities that they can make their way into the brain, also into the filtering organs like the liver and the kidneys. In fact they could collect there and maybe form tumors, we don’t know.”

Of course, that sort of ominous speculation is unhelpful to a fact-based, scientific approach to nanotechnology risk. Unfortunately, for the vast majority of the general population, who are unlikely to read the actual results of ongoing nanorisk-related research published in science-focused publications, this type of YouTube report is far more likely to be reviewed and relied upon as “fact.”

Source: Nanotechnology.org

Silver Nanoparticle Beneficial Use: New Study Shows that Ag Nanoparticles Mitigate the Cell Damage Caused by Alcohol

Thu, 27 May 2010 13:05:56 GMT

Much has been published in the past two years about the potential health and environmental hazards posed by silver nanoparticles used in a number of consumer products. This post concerns a positive story about nanosilver.

The cover story of the May 26, 2010, edition of the Journal of the American Chemical Society (JACS) describes how nanoparticles formed by very small numbers of silver atoms can protect against the cell damage caused by ethanol.

The study combines analysis of the electrocatalytic properties of silver nanoparticles with examination of their potential biological applications, and was led by researchers from the University of Barcelona in conjunction with the Magnetism and Nanotechnology laboratory of the University of Santiago de Compostela.

Gustavo Egea, a professor with the Department of Cell Biology, Immunology and Neurosciences of the Faculty of Medicine at the UB, explains "[T]he results of the study show that these clusters of small numbers of silver atoms catalyze ethanol oxidation at similar concentrations to those found in the blood of alcoholics and at values of membrane potential and pH that are compatible with those exhibited by mammalian cells."

Researchers applied the silver nanoparticles to a type of nerve cell (astrocytes) that were exposed to ethanol. These types of cells accompany neurons and are widely used as models for studying the physiopathological mechanisms of alcohol in fetal alcohol syndrome. Alcohol has particularly harmful effects on nerve cells, and in the specific case of astrocytes it induces programmed cell-death and an alteration of the actin cytoskeleton.

Following application of the silver nanoparticles to ethanol-exposed cells, the actin cytoskeleton shows marked improvements and cell-death does not occur. "So, the harmful effect of ethanol on astrocytes is mitigated by the silver nanoparticles, which act as a cytoprotective agent", explained Javier Selva, a lecturer with the Department of Cell Biology, Immunology and Neurosciences and first author of the paper.

The study also found that the nanoparticles prevent alterations induced by other primary alcohols such as methanol and butanol, although not those induced by other toxins such as hydrogen peroxide.

See the article at
Silver sub-nanoclusters electrocatalyze ethanol oxidation and provide protection against ethanol toxicity in cultured mammalian cells. Javier Selva, Susana E. Martínez, David Buceta, María Rodríguez-Vázquez, M. Carmen Blanco, M. Arturo López-Quintela and Gustavo Egea.

Sources: University of Barcelona, Journal of the American Chemical Society, Meridian Nanotechnology and Development News

Canada : Interim Policy Statement on Health Canada's Working Definition for Nanomaterials

Mon, 24 May 2010 13:39:07 GMT

Currently, the Acts and Regulations administered by Health Canada have no explicit reference to nanomaterial. In recognition of the need to keep pace with advances in this area and to collect information on risks associated with nanomaterials, Health Canada has adopted the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (IPS)

The IPS “will be applied in specific regulatory contexts across the Department to support the assessment of nanomaterials and to provide assistance to manufacturers and other stakeholders in meeting their respective statutory obligations.”

More specifically, the IPS will be applied under Acts and Regulations which are relevant to nanomaterials at Health Canada, which include but are not limited to:

(1) Food and Drugs Act
    - Cosmetic Regulations
    - Food Additive Regulations
    - Food and Drug Regulations
    - Medical Devices Regulations
    - Natural Health Products Regulations
    - Novel Food Regulation
    - Safety of Human Cells, Tissues and Organs for Transplantation Regulations

(2) Canadian Environmental Protection Act 1999
- New Substances Notification Regulations (Chemicals and Polymers)
- New Substances Notification Regulations (Organisms)

(3) Hazardous Products Act

(4) Pest Control Products Act
- List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern
- Pest Control Products Regulations

Next Steps
Health Canada recognizes that the state of nanomaterials science is evolving and that a flexible approach is warranted to capture important changes as our knowledge about real and perceived risks and benefits related to nanomaterials continues to develop. As a result, Health Canada says that comments on the IPS will be accepted until August 31, 2010, and the IPS will be updated as comments are received, as the body of scientific evidence increases, and as international norms progress.

Source: Health Canada

Big Risks Posed by Nanomaterial Regulators' Lack of Uniform Definitions

Wed, 19 May 2010 05:48:27 GMT

Prudent manufacturers, sellers, and employers in the nanotechnology community must maintain knowledge of all relevant standards, whether governmental, NGO, or industry-developed. But there is frustration with the uncertainties about the regulatory definitions of chemicals, materials, and products made with nanotechnologies.

This is an area worth watching closely. The current confusion and likely permanent lack of complete uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has tremendous implications those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk. Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

An article in the BNA Daily Environment Report explores the differing regulations and standard definitions coming out of various United States agencies – even different definitions from offices within the same agency. For example, the EPA’s Office of Pesticide Programs (OPP) uses this definition of a "nanoscale material": "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers," along with a new policy stating that an active or inert ingredient will be considered new if it is nanoscale. But the size-based focus of that definition is different from the one used by the EPA's Office of Pollution Prevention and Toxics (OPPT), which says size alone does not determine whether or not a chemical is new, and therefore subject to review under the Toxic Substances Control Act (TSCA).

The confusion – and the obvious implications for compliance costs and downstream risk borne by organizations producing or using nanomaterials – is enough for some U.S. companies to openly question whether they should keep its operations in the U.S. or move them offshore, perhaps to China. That includes QD Vision Inc., a company making quantum dots for lead- and cadmium-free lighting and display products. These are precisely the type of new technologies and related-manufacturing that the United States economy badly needs to nurture and expand, not drive away.

Dozens of countries are working to develop standard definitions of terms that scientists, manufacturers and regulators could use to refer to nanoengineered chemicals, materials and products. The International Organization for Standardization's (ISO) Technical Committee 229 on nanotechnologies will meet later this month (May 2010) to discuss a set of "core terms" and definitions it hopes to publish by the end of 2010.

Corporate officials and compliance lawyers hope the definitions from the ISO will help. Terry Medley, global director for corporate regulatory affairs at DuPont, says "[T]o have an effective global discussion on these questions, it is critical to have a clear and consistent definition of the term 'nanomaterial.' This global industry coalition is working to develop consensus on such a definition."

The BNA article can be viewed online at the link below.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=17181750&vname=dennotallissues&fn=17181750&jd=a0c3d2z0z9&split=0

Sources: The Bureau of National Affairs' Daily Environment Report; Meridian Nanotechnology and Development News

nanoTox™, Inc. COO Advises Nanotechnology Companies to View Safety Concerns as an Opportunity to Gain Trust

Sun, 16 May 2010 10:00:35 GMT

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.

“Schneider’s articles expresses quite well the public’s concern about nanomaterials.” King added. “No new technology gains wide consumer acceptance until potential safety concerns are addressed and resolved.

“Companies wanting to successfully commercialize products that contain nanomaterials will need to address those safety concerns. This is especially true for nanoproducts that have direct human contact, such as textiles, foods, medicines, cosmetics, personal care products. The companies that can demonstrate that their products are safe will have a competitive advantage.”

“The nanotech revolution is one of the best opportunities for cosmetic, food, and other companies incorporating nanoparticles to build new trust with their existing and future customers,” said King. “By showing that they are ahead of the game, they can inoculate themselves against negative perceptions and even champion themselves as leaders in product safety.”

About nanoTox™, Inc.
King is the author of several articles on nanotechnology risk management and nanotechnology regulation. nanoTox™ helps companies commercialize their products by helping address safety issues and responding to regulatory requirements. nanoTox™ offers to determine the toxicity of its clients’ nanoproducts and offers strategies for managing, reducing or eliminating risk to meet state and federal safety guidelines and shorten time to market. Because nanoTox™ uses methodologies that are performed under recognized international data quality standards (GLP, ISO, etc.) in its laboratories, the results and associated assessments are suitable for use to support regulatory decisions, product registrations, litigation and for acceptance by the insurance industry.

Source: Nanowerk News, nanoTox™, Inc.

AOL News Special Report Series on Nanotechnology Safety: Misleading Portrait or Fair Picture?

Wed, 12 May 2010 09:31:11 GMT

“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.

In a recent opinion piece, Clayton Teague, the director of the United States National Nanotechnology Coordination Office, responds to the AOL News Special Report. Teague argues that the series "failed readers by ignoring the federal government's evidence-based, multipronged strategy for ensuring the safety of new products produced by nanotechnology." The United States is, says Teague, the global leader in nanotechnology-related environmental, health and safety (EHS) research and development, investing US$254 million from 2005 to 2009, more than all other countries in the world combined.

Teague takes issue with Schneider's depiction of the federal regulatory regime with regard to nanotechnology, and details what relevant agencies are doing to ensure that nanoengineered particles are adequately regulated. He concludes by saying that the National Nanotechnology Initiative (NNI) members welcome new data and critical analysis from all sources, but adds that "in order to provide balance to the series on nanotechnology, your readers need to know the federal EHS research effort is vigorous and well funded, and that the government is regulating nanomaterials and nanoparticles."

The Teague opinion article can be viewed online at the link below.
http://www.aolnews.com/nanotech/article/opinion-aol-news-paints-a-misleading-portrait-of-nanotechnology/19446823

Evidence that ZnO Nanoparticles in Sunscreens Could Be Toxic if Accidentally Eaten

Mon, 10 May 2010 08:39:18 GMT

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?

In a study published in the American Chemical Society monthly journal Chemical Research in Toxicology, scientists from the University of Utah are reporting that particle size affects the toxicity of ZnO, a common ingredient in sunscreens. Some suncreens already contain ZnO nanoparticles and the research found that particles less than 100 nm in size were more toxic to colon cells than conventional ZnO. The scientists compared the effects of zinc oxide nanoparticles versus the effect of zinc oxide on cell cultures of colon cells and found the nanoparticles to be twice as toxic to the cells as the larger particles. Solid ZnO was more toxic than equivalent amounts of soluble zinc, and direct particle to cell contact was required to cause cell death.

According to the scientists, "[U]nintended exposure to nano-sized zinc oxide from children accidentally eating sunscreen products is a typical public concern, motivating the study of the effects of nanomaterials in the colon." The concentration of zinc oxide nanoparticles that was toxic to the colon cells was equivalent to eating two grams of sunscreen, or about 0.1 ounce.

This study used isolated cells to study biochemical effects and did not consider the changes to particles during passage through the digestive tract. The scientists say that further research should be done to determine whether zinc nanoparticle toxicity occurs in laboratory animals and people.

See the study in ACS’ Chemical Research in Toxicology, "ZnO Particulate Matter Requires Cell Contact for Toxicity in Human Colon Cancer Cells".

Sources: American Chemical Society, Nanowerk, Meridian Nanotechnology and Development News

Nanotechnology Risk -- Online Web Seminar: "Understanding Nanotechnology Safety" 5/27/10

Thu, 06 May 2010 18:00:19 GMT

Friends,

An online seminar, "Understanding Nanotechnology Safety", will be webcast on May 27, 2010, at 1:00 U.S. EDT and is intended for anyone concerned about the potential health hazards of exposure to nanoengineered materials.

The seminar, sponsored by Small Times (note: Small Times is a leading source of business information and analysis about nanotechnology), will educate about:

- trends in nanotechnology and how it is used in manufacturing;

- risks of nanotechnology;

- what can happen to the body when exposed to hazardous nanomaterials;

- how to minimize the risk of exposure; and

- government safety regulation.

Presenters include: Mark Bünger Research Director, Lux Research; Walt Trybula, Director of the Nanomaterials Application Center, Texas State University-San Marcos; Dr. Kristen Kulinowski, Department of Chemistry, Rice University; Nina Horne, Invited Expert; and, Dr. Antonietta M. Gatti Ph.D., Experimental Physics University of Bologna, Italy.

Cost is $129.00 ($99.00 for registration by May 10, 2010). Seminar length is 2 hours.

Registration information can be viewed online at the link below.
http://downloads.pennnet.com/digitalmedia/st/stwebcast2.html

For those of you hungry for an opportunity to learn more about the current state of nanotechnology risk, in a compact 2 hours for a modest fee, this looks like a great opportunity.

Johns Hopkins to hold 4th Annual Symposium on Environmental and Health Impacts of Engineered Nanomaterials

Fri, 09 Apr 2010 09:28:22 GMT

The Johns Hopkins Institute for NanoBioTechnology will hold its fourth annual symposium, “Environmental and Health Impacts of Engineered Nanomaterials,” on Thursday, April 29, at the Johns Hopkins Bloomberg School of Public Health.

This year’s symposium brings together faculty experts engaged in various aspects of nanotechnology risk assessment and management research.
Jonathan Links, an INBT-affiliated professor in the Department of Environmental Health Sciences, assembled the slate of speakers from across four divisions of the university. Links said that this diversity reflects the multidisciplinary approach needed to effectively address questions of how nanomaterials move through and interact with the environment, and how they may impact biological organisms, including humans.

Despite some concerted efforts to assess risk, many questions remain unanswered about how engineered nanomaterials and nanoparticles impact human health and the environment. “Without these data, we are flying blind. But when risk assessment is performed in tandem with research into beneficial applications, it helps researchers make better decisions about how nanotechnology is used in the future,” Links said.

As examples, Links pointed to historical cases where research and development have failed to recognize risks to health and the environment until after a beneficial advancement was already in widespread use. The fibrous substance asbestos, he said, made construction materials flame retardant but is now linked to lung diseases; chlorofluorocarbons made effective air conditioning coolants but are now associated with the depletion of the ozone.

“Studying potential risks to human health and the environment hand in hand with benefit-driven research and development gives us the best chance to reduce risk proactively while maintaining the benefits,” Links said.

Along with Links, scheduled speakers at the symposium will include: Ellen Silbergeld of Environmental Health Sciences; Patrick Breysse of Environmental Health Engineering and Environmental Health Sciences; William P. Ball, a professor in the Whiting School of Engineering’s Department of Geography and Environmental Engineering; Justin Hanes, a professor in the School of Medicine’s Department of Ophthalmology, with joint appointments in the Whiting School’s Department of Chemical and Biomolecular Engineering and the Bloomberg School’s Department of Environmental Health Sciences. Howard Fairbrother, a professor in the Krieger School of Arts and Sciences’ Department of Chemistry, will talk about the transport of nanomaterials through environmental and biological systems, as well as the unusual properties of manufactured nanomaterials.
Tomas Guilarte, recently appointed chair of the Department of Environmental Health Sciences at Columbia University’s Mailman School of Public Health and a former professor at the Bloomberg School, will provide a presentation on neurotoxicity of nanoparticles. Ronald White, an associate scientist and deputy director of the Bloomberg School’s Risk Sciences and Public Policy Institute, will discuss policy implications based on risk assessment.

Symposium talks will be from 8:30 a.m. until noon in Sheldon Hall (W1214), and a poster session, with prizes for top presenters, will be held from 1:30 to 3 p.m. in Feinstone Hall (E2030).

To register for the symposium or to display a poster, go to http://inbt.jhu.edu/
symposium/registration. Specific symposium questions may be addressed to Mary Spiro at mspiro@jhu.edu.

First Nano-Specific Liability Insurance: Lexington Insurance Company Introduces "LexNanoShield"

Tue, 06 Apr 2010 09:32:11 GMT

On March 30, 2010, the Lexington Insurance Company, Boston, MA, introduced LexNanoShield, an insurance product aimed at those firms whose principal business is manufacturing nanoparticles or nanomaterials, or using such substances in their processes.

Tom McLaughlin, Lexington's Senior Vice President of Specialty Casualty, says "[T]he enhanced reactivity of materials on the nanoscale has led to sunscreens you can't see, clothes that don't wrinkle, and paint coatings that don't scratch. Because many of these products and others like them are relatively new, they require unique coverage and service. LexNanoShield can help insureds assess and manage these new nanotechnology exposures."

In response to the loss exposure concerns expressed about nanotechnology, Lexington Insurance provides integrated liability coverage and an array of risk management services to help those insureds manufacturing, distributing, or using nanoparticles or nanomaterials assess and manage their products liability exposures.

Target Classes
Medium to small manufacturers or distributors of nanoparticles and/or nanomaterials domiciled in the United States

Coverage Highlights
LexNanoShield includes an integrated liability insurance product that extends explicit coverage for nanotechnology exposures arising out of:
– General liability
– Products liability
– Products pollution legal liability
– Product recall liability
In addition, LexNanoshield reimburses first party product recall expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons.

Risk Management Services
LexNanoShield provides a broad array of services including:

– Up to two hours of confidential consultation with a national law firm with
expertise in nanotechnology to assist with appropriate risk allocating contract
language, product labeling, product warranties, development and/or review of
a nanotechnology risk management program, and/or participation in the EPA
Nanoscale Materials Stewardship Program under the Toxic Substances Control Act (TSCA) of 1976

– Up to two-hours of outside technical consulting services in the areas of
toxicology or environmental health and safety to help with developing,
implementing, or assessing a nanotechnology risk management program

– On-site loss control consultations specific to mitigating hazards of
nanomaterials used in the manufacturing process or included in the product

For more information regarding LexNanoShield, contact Bob Nevin, Product Line Manager, at 617-772-4546 or robert.nevin@chartisinsurance.com, or Tom McLaughlin, Senior Vice President of Lexington’s Specialty Casualty unit, at 617-330-8555 or thomas.mclaughlin@chartisinsurance.com. You can also visit www.lexingtoninsurance.com.

According to the Nanotechnology Law Report, which covers legal issues surrounding nanotechnology, this is the first nano-specific liability coverage available in the United States. John C. Monica, JR., who covered the story for the Nanotechnology Law Report, writes that "[M]any nano-related businesses have been waiting a long time for a product like this. It will be interesting to see industry reaction."

Sources: Nanotechnology Law Report, Lexington Insurance Company

Top U.S. Science Advisers Call for More and Better Research on Nanotech Environmental, Health and Safety Concerns

Tue, 16 Mar 2010 12:01:24 GMT

The President's Council of Advisors on Science and Technology (PCAST) last week approved a report that urges "federal agencies to increase their collaboration on environmental, health, and safety questions arising from various applications of nanotechnologies."

The PCAST, which meets only once every two years, reviews the federal National Nanotechnology Initiative (NNI). The Council's last report evaluating the multi-agency NNI was criticized by some for not paying sufficient attention to environmental, health and safety concerns. But the spokesman for the White House Office of Science and Technology Policy (OSTP), the office that manages PCAST, said the new report will include a substantial chapter on environmental, health and safety issues.

Ed Penhoet, a director of Alta Partners and the co-chair of the PCAST subcommittee developing the report, added that the report will recommend that the federal government develop a "cross-agency strategy plan that links environmental, health, and safety research with knowledge gaps and decision-makers' needs."

The PCAST report comes short on the heels of, and is consistent with, the President’s recent FY 2011 Budget Request for the NNI. In that proposed budget, participating NNI agencies would provide $119 million for nanotech EHS research, about a 22% increase compared with the FY 2010 level. Importantly, the FDA and the CPSC are each included for the first time. For more detail, see my 2/19/10 blog post, U.S. Government Nanotechnology Safety Research To Get Serious.

An article about the PCAST report is available from BNA’s Daily Environment Report.

Source: The Bureau of National Affairs Daily Environment Report and Meridian Nanotechnology and Development News

Atmospheric Nanoparticles: Do They Affect Weather and Human Health?

Wed, 10 Mar 2010 09:12:01 GMT

Atmospheric nanoparticles can’t be seen with the naked eye, but they can very visibly affect both weather patterns and human health all over the world – and not in a good way, according to a study by a team of researchers at Texas A&M University.

The study was published in the current issue of Nature Geoscience and was funded in part by the National Science Foundation. The research team from the Texas A&M Departments of Atmospheric Sciences and Chemistry examined how atmospheric nanoparticles are formed as well as their relationship and interaction with certain organic vapors in the air. Atmospheric nanoparticles may form either naturally or through man-made processes, such as traffic emissions, manufacturing processes, and now through the rapidly growing use of engineered nanoparticles.

"This is one of the most poorly understood of all atmospheric processes," says Renyi Zhang, one of the study's researchers. “These nanoparticles are very small – about one million times smaller than a typical raindrop,” Zhang says. “But what they do can have a huge effect on our weather. We found that certain types of organics tend to grow very rapidly. When this happens, they scatter light back into space, and that definitely has a cooling effect – sort of a reverse 'greenhouse effect.' It can alter Earth's weather patterns and it also tends to have a negative effect on human health." These nanoparticles can also form the basis for cloud droplets and lead to cloud formations and global weather affects.

TheTexas A&M News article and an informative video can be viewed online at the link below.
http://tamunews.tamu.edu/2010/02/28/atmospheric-nanoparticles-impact-health-weather-prof-says/

Sources:Texas A&M University, Meridian Nanotechnology & Development News.

Nano-Risk Books of Interest

Tue, 09 Mar 2010 14:46:57 GMT

I want to let you know about two books (both available in paperback) that have some good information about nanotechnology risks to health and the environment. These would be especially helpful for a non-scientist that wants to get a good sense of the general range of risk issues.

1. Nanotechnology: Consequences for Human Health & the Environment

Ronald E. Hester (Editor), Roy M. Harrison (Editor)

This book is Volume 24 in the "Issues in Environmental Science and Technology" series of books from the Royal Society of Chemistry (RSC Publishing). It is a very good introduction to most of the important nano-risk issues, although it is not "leading edge" anymore:

- Current and Future Applications of Nanotechnology (pp 1-18), Barry Park

- Nanoparticles in Acquatic and Terrestrial Environments (pp 19-34), Jamie Lead

- Nanoparticles in the Atmosphere (pp 35-49), Roy Harrison

- Occupational Exposure to Nanoparticles and Nanotubes (pp 50-80), David Mark

- Toxicological Properties of Nanoparticles and Nanotubes (pp 81-101), Ken Donaldson and Vicki Stone

- Human Effects of Nanoparticle Exposure (pp 102-117), Lang Tran, Rob Aitken, Jon Ayres, Ken Donaldson, and Fintan Hurley

- Nanoparticle Safety – A Perspective from the United States (pp 118-132), Andrew Maynard

2. What Is Nanotechnology and Why Does It Matter?: From Science to Ethics

F. Allhoff, P. Lin, and D. Moore

Allhoff and Lin are co-founders of The Nanoethics Group and co-editors of two anthologies in nanoethics, and Moore is an advisory board member of the same organization.

The book is divided into three units:

Unit 1—What is Nanotechnology—covers the basics of nanotechnology, tools of the trade, different types of nanomaterials, and current and future applications of nanotechnology.

Unit 2—Risk, Regulation, and Fairness—discusses risk, precaution, regulation, equity, and access.

Unit 3—Ethical and Social Implications—focuses on some of the most urgent issues: environment, military, privacy, medicine, and enhancement.

Dr. Eric Drexler, considered by some to be a "father of nanotechnology" with his seminal book Engines of Creation (1986), called the new book "a broad and balanced examination of the nature of nanotechnology, how it is unfolding, and how these developments will affect issues of global concern."

Nanotech Environmental Health and Safety (EHS): SAFENANO's Review of 2009 and Look Ahead at 2010

Mon, 08 Mar 2010 13:19:01 GMT

SAFENANO recently prepared an article -- SAFENANO Review of 2009 -- detailing some of the key developments in nanotechnology environmental health and safety (EHS) from 2009, and reflecting on what's in store for 2010.

The SAFENANO Report observes that while there has been an enormous increase in research carried out, with interesting studies beginning to emerge, few of the key issues relating to exposure and toxicology and risk of nanoparticles and nanotubes have been answered in a satisfactory way.

The Report details, among other things: 2009 articles of importance from various sectors, including academia, nongovernmental organizations, and government; guidance documents; resources and tools; government directives, activities, and regulation; and, databases.

The Report concludes that there is no sign of a let up in activity underway in this field, but identifies several specific areas for substantial new research to be undertaken: in vivo data; exposure to workers; consumer exposure to nanomaterials and the the possibility of dermal absorption and toxicity; and, responsible reporting of nanotechnology EHS findings.

About SAFENANO: SAFENANO is a highly respected venture by the UK's Institute of Occupational Medicine (IOM), to help industrial and academic communities quantify and control the risks of nanotechnology to their workforces, as well as to consumers and the general population. The IOM advises UK government agencies on the potential risks of nanotechnology to health, and management of these risks. SAFENANO is a credible source for nanotechnology risk information, and that is why its website enjoys statut as one of the "Links" to this blawg that I recommend to all those who want to maintain a working knowledge of nanotechnology risk.

Sources: SAFENANO; Meridian Nanotechnology & Development News

Nanotoxicity : A Methodology for Measuring Uptake and Effects of Nanomaterials in the Blood Stream?

Fri, 05 Mar 2010 17:37:47 GMT

A team of University of Calgary, Alberta, researchers are a step closer to helping solve a complex problem in the developing field of nanotoxicology: how to relate the physical properties of nanomaterials to potential risk when organisms are exposed to those materials. To study the physicochemical nature of nanoparticle accumulation in blood vessels or tissue, one needs to measure the nanoparticle properties in situ, because these properties could be significantly dependent on environment. But how to make such measurements?

Chemistry professor David Cramb, director of the Faculty of Science's nanoscience program, and his researchers have developed a methodology to measure various aspects of nanoparticles in the blood stream of chicken embryos. Their discovery is published in the March 2010 online edition of Chemical Physics Letters.

"With the boom in nanomaterials production there is an increasing possibility of environmental and/or human exposure. Thus there is a need to investigate their potential detrimental effects," says Cramb. "We have developed very specialized tools to begin measuring such impacts."

Cramb is looking for ways to help answer questions including: If embryos are exposed to nanoparticles, where will the nanoparticles go? How will the embryo respond? What regulatory approaches can be recommended to mitigate accidental exposure? How can nanotechnology be made green and sustainable?

"Bioaccumulation studies involving embryos are being conducted in our laboratory," says Cramb. "These studies are important since chronic nanotoxicity in an adult organism could be related to exposure during the development process. Additionally, acute exposure may affect embryonic viability."

The new methodology is based on studying motion and light induced changes in nanoparticles by focusing a laser beam into a blood vessel containing nanoparticles and measuring fluorescence. The measurements provide a determination of nanoparticles aggregation in the vessel) This is unique because it has never been done in a live embryo. The results will now allow measurement and understanding of uptake into embryonic tissues.

Sources: University of Calgary, Chemical Physics Letters

“Safe By Design” : Is The Holy Grail of Nanotechnology Plausible?

Thu, 04 Mar 2010 18:19:38 GMT

Dr. Sally Tinkle, senior science advisor at the United States National Institute of Environmental Health Science, part of the National Institutes of Health, wrote an intriguing article recently, Examining the Holy Grail of Nanotechnology: Safe By Design.

Dr. Tinkle discusses the idea that nanomaterials can be engineered to be Safe by Design (SxD), meaning that they are designed to "maximize their benefit in problem solving and product development while posing minimal risk to human health and the environment."

Dr. Tinkle says there are many assumptions that underlie this idea, as well as consequences that might be engendered by it, and she briefly discusses a number of them. The most important assumption of SxD – as yet unproven – is that the adverse effects of an engineered nanomaterial (ENM) could be engineered out through the manipulation of physical and chemical properties, while the beneficial properties are maintained. But lots of research is needed before it is established that modifications to an ENM that "tweak" a product to decrease risk of an adverse effect can be made without significantly changing the benefit the ENM confers on a product.

Underlying the SxD principle is the also as-yet-unproven assumption that researchers will be able to identify the specific physical and chemical properties that produce the distinct sets of beneficial or adverse effects.

Dr. Tinkle concludes by suggesting that SxD is likely to be possible, but cautions that it is "an intriguing concept with the potential to guide ENM product design and development to maximize benefit and minimize risk to humans and their environment. Broad principles that relate physical and chemical properties to behavior could be determined from careful selection and testing of ENM and microenvironments, however one should consider the cost benefit ratio that would underlie this extensive investigation of design principles in contrast to the perhaps less expensive product-specific analysis of risk and benefit."

Nanotech watchers like me are aware of some early research supportive of the SxD concept with some types of nanoparticles, but it is far too early to declare that we've actually seen a glimpse of the Grail.

Sources: AZoNano.com, Dr. Sally Tinkle (National Institute of Environmental Health Science, National Institutes of Health)

New Australian Study Finds Common Nanoscale Sunscreen Ingredient (zinc oxide) is Absorbed Into Bloodstream

Wed, 03 Mar 2010 07:38:07 GMT

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.

The study, by Geochemist Brian Gulson of Sydney's Macquarie University, provides the first conclusive evidence that zinc oxide nanoparticles - which appear in many translucent sunscreens - can be absorbed by the body and remain there for extended periods of time.

Although Professor Gulson’s study did not address the potential effects zinc nanoparticles have on the body's cells or immune system, previous research has established that long-term exposure to high levels of zinc can cause copper deficiency, which slows the body's vital enzyme processes.

Gulson’s study applied specially formulated sunscreen with "traceable" zinc oxide isotopes to 20 people of various ages, skin types and races over five days and took blood and urine samples from each. All participants subsequently experienced elevated levels of zinc in their blood and urine, which remained there for some time.

It was previously thought substances rubbed on the skin could not permeate its upper layers. Professor Gulson said his findings were "significant" and urged cosmetic companies to "slow down" on the number of consumer products that contained nanoparticles.

Almost 400 sunscreen products sold in Australia contain nanoparticles in amounts ranging from 4 per cent to 30 per cent, Australia's Therapeutic Goods Administration says.

Source: The Australian

Nanomaterial Waste : African Fear of “Dumping” Leads to Resolution to Ensure Safe Handling

Mon, 01 Mar 2010 07:11:03 GMT

Although it has received very little notice, the governments of all 53 African countries adopted a resolution concerning nanotechnology safety during the Strategic Approach to International Chemicals Management (SAICM) regional meeting in Abidjan, Cote D’Ivoire, on January 28, 2010.

The non-binding resolution calls on countries creating nanomterials and nanomterial-containing products -- like the United States -- to ban shipments of nanomaterial-containing wastes to countries that lack the capacity to properly and safely manage the materials.

The resolution stems from African countries’ fears about the unknown environmental and health effects of nanoengineered materials and waste containing nanomaterials, which are being shipped to Africa by developing countries. The African countries do not want decisions about the shipping of these materials to be made without them "at the table" and their resolution calls for legal principles to ensure the safe production, use, transport, and disposal of these materials. Additionally, the resolution calls for a "no data, no market" principle, which would require, prior to commercialization, the submission of comprehensive hazard assessment information.

The African countries are obviously trying to avoid some of the painful lessons they know only too well from past dumping of toxic materials that later were found to have caused environmental and human damage.

It will be interesting to see to what the extent the resolution leads to actual policy and action.

Sources: The Bureau of National Affairs, Inc.; Meridian Nanotechnology & Development News

Sweat The Small Stuff : An Introduction to Nanotechnology and Products Liability: Part 4 of 4

Tue, 23 Feb 2010 18:10:49 GMT

This is part four of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Generally speaking, nanomaterials pose the same problems to products liability lawyers that macro products do. Manufacturing defect, defective design, and failure to warn are not going away. But nanomaterials do pose some unique problems within each cause of action. Part 4 is an overview of those various problems.

General Causation
The size and soon-to-be prevalence of nanomaterials will make proving causation in a court room problematic. For instance, if John develops a respiratory problem, he will first have to undergo expensive and high-tech medical diagnostics to even know that nanotechnology was the cause. He will have to hire a convincing medical expert to show a jury that nanotech, and not something else like smoking, occupational hazards, asbestos, or naturally occurring nanoparticles is the culprit. Then, he will need to hire an expert to determine where the nanoparticle came from. If John’s pants, household electronics, paint, and automobile all contain similar nanoparticles, it may be impossible to isolate the source. Traditionally, only once the product is actually isolated, could John even begin to make a claim. In other words, being a nano-plaintiff is an expensive proposition.

In response, sympathetic courts could develop new doctrines to help plaintiffs cope with the increased difficulty of nano-litigation. Perhaps the Res Ipsa Loquitur doctrine will make a pronounced comeback. Or plaintiffs may engage in industry wide and cross-industry suits. Enterprise liability would be another way of sorting through the muck.

Enterprise Liability
Sindell v. Abbott Laboratories, 607 P.2d 924 (1980), provides an instructive model of how enterprise liability might work for nanotechnology. Essentially the burden of proof is shifted to defendants to prove that their product did not cause the disease. The manufacturers are in the best position to know that information. If an individual defendant can prove that it is not liable, it pays no damages. Otherwise, it pays damages at a rate equivalent to its market share. Six states (California, New York, Washington, Florida, Wisconsin, and Michigan) have adopted enterprise liability standards similar to Sindell for specialized circumstances.

Warning Labels
Nanotech also poses unique issues regarding warning labels. Currently, manufacturers do not have to inform consumers of the presence of nanomaterials. Many companies use the effects of nanotechnology as a selling point, without overtly identifying the nanotechnological component. I have been unable to locate a single warning label that warns about potential dangers from nanomaterial inhalation or absorption.

It is unclear how companies would warn against nanoparticles anyway. The medical risks and issues surrounding the technology are complicated. The difficulty in designing a graphic depiction of nanotechnology inspires laughter.

But, companies could warn against behaviors that may tend to lead to nanomaterial exposure. For example applying sunscreen containing nanotech to an open wound could result in unsafe absorption levels. Another example would be a general warning about the use of respirators when using paint infused with nanotech. It is very difficult to imagine how companies would warn against certain potentially (and unwittingly) dangerous activities. For instance, wearing clothing made with nanotech stain fighters could be very dangerous if the nanotubes begin to break away from the larger structure and form particulate matter. Companies would essentially have to warn not to wear a “worn-out” shirt in that case. It is unlikely that type of warning would even be effective.

Reasonable Alternative Design
Nanotech also turns the table on Reasonable Alternative Design. Often, plaintiffs are forced to find an engineering expert to design them a newer and safer alternative. Generally, the Reasonable Alternative Design is futuristic. But in the case of nanotechnology, often the Reasonable Alternative Design will be something everyone is already used to seeing, using, and wearing. Imagine for a moment that Dockers is sued in a mass tort action because its stain-defender pants have allegedly caused respiratory problems and heart attacks. The Reasonable Alternative Design that plaintiffs will be championing is the OLD Dockers pants.
That will not be the case in every instance, because nanotech will not only change current products, but create new ones that would previously have been unimaginable. Those cases will be challenging and expensive for the plaintiffs. Plaintiffs will have to hire an expert in nano-engineering who is also capable of explaining to the average juror why NanoTech, Inc. is wrong. Will juries really be able to tell the difference between competing forms of carbon nanotubes?

Learned Intermediary
In the pharmaceutical arena, the defense of learned intermediary may need significant alteration. Doctors are specialists at understanding biological processes and chemical interactions. But they are not engineers. The health problems associated with nanotech are equal parts engineering, physics, biology, and chemistry. Doctors are at a decided disadvantage in half of those areas. Either medical schools will begin to offer advanced specialties in nanomedicine or specialized technicians will develop to work with doctors. Either way, it is possible that “learned intermediary” becomes a relic.

Conclusion
Nanotech offers wondrous opportunities. If the technology ever reaches its true potential, it offers the ability to solve any problems it could create. If nanotech causes cancer, scientists can develop cancer fighting nanobots to treat the disease. If nanotech hurts the environment, scientists could create nanomaterials to attack the ecological destruction. But first, the nanotech industry has to survive to reach its potential. Right now, people are skeptical and are unlikely to see benefits on the horizon. In the status quo, nanotech represents stain resistant pants, not cures for diseases.

Encouraging the industry to manage risk through the creation of a hybrid liability-regulatory framework is important. The industry needs the flexibility of the market and also the rigidity and trustworthiness of the government. Products liability lawyers need to advocate the hybrid framework in the public sphere and in the board room. In the court room, products liability lawyers will face increasingly difficult questions that strain current legal norms.

-Nick Dudley

Sources:
-Quinley, Kevin, A Risk Manager’s Approach to Nanotechnology, http://www.nanowerk.com/spotlight/spotid=14021.php
-Hall v. Dupont, 345 F.Supp. 353 (E.D.N.Y. 1972)
-Sindell v. Abbott Laboratories, 607 P.2d 924 (1980)

U.S. Government Nanotechnology Safety Research To Get Serious

Fri, 19 Feb 2010 17:10:38 GMT

The Obama Administration’s just-released National Nanotechnology Initiative’s (NNI) Supplement to the President’s 2011 budget indicates that the United States is doing some catch-up with Europe in addressing the safe development and use of nanotechnology-enabled materials, products and processes.

The best discussion and commentary I have seen on the issue is from Andrew Maynard in his blog 2020 Science. Here is some of what Maynard views as noteworthy:

Food and Drug Administration (FDA): The FDA is requesting $15 million in 2011 to address nanotechnology environment, safety and health issues. This is the first time that the agency has been listed in the NNI budget supplement as requesting nanotechnology-specific funding. Previously hobbled in its approach to supporting the responsible development of nanotechnology because of a lack of funding, this should go a long way to help the agency get on top of critical oversight-related questions. The requested funds will support laboratory and product testing capacity, scientific staff development and training, and collaborative and interdisciplinary research to address product characterization and safety.

Consumer Products Safety Commission (CPSC): The CPSC joins the FDA in being part of the NNI budget cross-cut for the first time since the NNI was formed. For 2011, the CPSC is requesting a much-needed $2.2 million to allow it to participate with other agencies in researching safety aspects of nanomaterials use in consumer products. Planned work includes developing protocols to assess the potential release of airborne nanoparticles from various consumer products and to determine their contributions to human exposure; determining whether nanomaterials can be used for performance improvement in sports safety equipment such as helmets and kneepads without creating other health hazards; and expanding consumer product testing using scientifically credible protocols to evaluate the exposure potential from nanosilver in consumer products, with special emphasis on exposures to young children.

National Institute for Occupational Safety and Health (NIOSH): The NIOSH is requesting $16.5 million for nanotechnology safety research in 2011; over 5 times more than the agency’s 2006 nanotech budget, and $7 million above the estimated 2010 budget. NIOSH has been leading the charge on developing safe workplace practices for handling engineered nanomaterials in recent years – and all on a shoestring budget. This significant increase in funding should help the agency address critical research needs it been struggling to cover adequately, including much needed work on exposure measurement and characterization.

National Institute for Standards and Technology (NIST): The NIST budget for nanotechnology safety research is set to double, going from an estimated $3.6 million in 2010 to a requested $7.3 million in 2011. The agency will target its nanotechnology safety program to measuring the dynamic physico-chemical and toxicological properties of key nanomaterials and the release of these nanomaterials during manufacturing processes and from products throughout full product life cycles.

When requests from other agencies are included, the 2011 budget request for targeted nanotechnology safety research across the federal government for 2011 comes to $116.9 million – three times the amount invested in 2006.

The United States has consistently lagged behind other regions of the world, in particular the EU, in devoting resources ($$) to nanotechnology environmental, health and safety (EHS) research. The most recent proposed NNI funding concretely demonstrates that the US government is committed to investing in EHS research that will underpin the development of responsible nanotechnology.

For more discussion and commentary, I encourage you to visit 2020 Science.

New U.S. Gov't Study Finds Common Nanoscale Sunscreen Ingredient (titanium dioxide) Does Not Penetrate Healthy Skin

Thu, 18 Feb 2010 11:22:56 GMT

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.

In the study, researchers tested three different preparations of titanium dioxide particles by spreading them on the skin of minipigs for 22 days. The study’s authors wrote that, "This study supports the conclusion that nano-sized TiO2 included in a formulation similar to currently marketed sunscreens does not significantly penetrate intact normal pig skin to any significant degree, and therefore is unlikely to significantly penetrate human skin."

Caution: the authors noted that the study did not rule out the possibility of adverse effects on damaged skin.

Source: The Bureau of National Affairs, Inc., Toxicological Sciences

Sweat The Small Stuff: An Introduction to Nanotechnology and Products Liability: Part 3 of 4

Wed, 17 Feb 2010 09:04:35 GMT

This is part three of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Products liability attorneys will face unique challenges from the nanotechnology industry. Part 3 suggests a broader coping strategy. Attorneys and insiders must find a balance between industry-wide security that some regulation would provide, while avoiding the choking effects of over-regulation.

Where Do We Stand?
Products liability lawyers are probably asking themselves: haven’t we done this before? Biotechnology, CFC’s, Asbestos, Nuclear Power – the list goes on and on. New technologies promising significant benefits have in many cases been crippled because of industry failures. In order for nanotechnology to avoid the same fate, the industry must be pushed in the right direction.

There is barely a regulatory framework of any kind in place to watch nanotechnology. In fact, the very nature of the technology itself is in such dispute, that attempts to define it for regulatory purposes have proven cumbersome. Products liability lawyers working for nanotech companies would be wise to lobby for increased regulation. No regulation leaves companies vulnerable to the courts like asbestos companies were. Overregulation may neuter the benefits of the technology. Nanotechnology needs a hybrid regulatory-liability framework to succeed.

In the status quo, the population at large (and thus the jury pool), is skeptical of nanotechnology companies. There is a definite “anti-hype” movement surrounding nanotechnology. Some are even wondering aloud if nanotech is the new asbestos. That skepticism could play out as an anti-nanotech bias in the deliberation room. Before a Senate committee, J. Clarence Davies declared, "The greatest threat to the future of nanotechnology and nanotechnology-based businesses is not regulation but a collapse in public confidence."

As discussed previously, nanotechnology means many things. The industry is wide and expansive. If one nanotech product turns out to be incredibly dangerous, it may result in a backlash against all or most nanotech products, even if those products are safe. Regulation provides symbolic value to help ease fears as well as the potential to cap liability. It is useful to compare nanotechnology to the asbestos and nuclear power industries.

The Asbestos and Nuclear Lessons
The asbestos companies died a death by a thousand cuts. The asbestos scare coupled with liability payments simply made it impossible for the industry to secure insurance and the companies simply closed down. The nuclear power industry’s challenge was different. The catastrophes at Chernobyl and Three Mile Island were jolts to the public. Public perception turned against the companies and Not In My Back Yard sentiments prevailed. But the industry managed to survive largely because liability was capped by the Price-Anderson Act.

Liability Plus Regime
There is a middle ground between over-regulation and over-exposed liability for nanotechnology. David Berube suggests a “liability plus regime.” His plan consists of three parts: voluntary data aggregation and collection, limited regulation by OSHA and the FDA, and some degree of liability caps.

The primary problem with any liability based regulation scheme is that a tremendous burden falls on insurance (and reinsurance) companies. This is troublesome for nanotechnology because the insurance companies have virtually none of the data needed for appropriate risk management. As a result, the industry is underinsured. When more data becomes available, insurance companies will be able to make better decisions. While the insurance companies do not have better data than the regulators at present, they do have the luxury of overcharging. Insurance companies are in a very powerful position right now in the nanotech industry. A voluntary data reporting program would definitely serve their interests. Insurance companies could effectively make reporting a de facto requirement for affordable insurance rates. The aggregated data would also allow manufacturers to better structure contracts. Downstream manufacturers could demand contractual agreements with nanomaterial suppliers that include penalties for late or non-disclosure of toxicology data.

Berube also recommends that OSHA continue to develop best practices, and that the FDA regulate nanotechnology in the area of drug and medical devices. That is probably easier said than done, but FDA and OSHA regulation are necessary to ensuring public confidence and safety.

Finally, Berube suggests capping liability or mandating insurance coverage. The government could step in for the nanotech industry like it did after the September 11, 2001 terrorist attacks. The Terrorism Risk and Insurance Act, passed in 2002, promised that the government would step in and cover 90% of insurance losses above a certain level. That would have the effect of ending any asbestos like insolvency problems due to liability. Or, nanotech advocates could follow the nuclear model instead, and ask for liability caps.

The nuclear and nanotech industries shared almost identical problems in risk management. Since data concerning the predictability and severity of accidents is sparse, insurers are likely to price companies out of the game, or not charge enough, leaving the insurers unable to make payouts in the case of disaster. As a result, nuclear style liability caps may be appropriate in the short term. At present nanotech is still its own industry. However, it is likely that nanotech firms will be absorbed into the larger economy by conglomerates and other businesses. Once nanotech is integrated, risk can much more easily be apportioned because the industry will have a kind of natural diversification. But until then, the industry is one health scare away from the brink.

Nanotechnology needs advocates in the broader arenas of public policy and public opinion, not just advocates in the court room.

-Nick Dudley

Part 4 will focus on specific legal challenges and strategies.

Sources:
-Berube, David, Regulating Nanoscience: A Proposal and Response to J. Clarence Davis, 3 Nanotechnology Law & Business 485 (2006)
-Clay Risen, Why We Need New Regulations of Nanotechnology, NEW REPUBLIC, Jan. 16, 2006
-J. Clarence Davies, Developments in Nanotechnology, Hearing Before the S. Comm. on Commerce, Sci. & Tech., 109th Cong. 2 (Feb. 15, 2006)

Article: "Nanotechnology: The Next Battleground for Mass Torts?"

Wed, 10 Feb 2010 18:49:02 GMT

You may be interested in an article published by BNA's Toxics Law Reporter in December 2009: "Nanotechnology: The Next Battleground for Mass Torts?"

The article by Scott DeVries and Sarah Jehl, attorneys experienced with environmental mass torts and insurance coverage, offers some potentially useful procedural suggestions for defense attorneys faced with nanotech-focused mass torts.

In particular, the authors tout the possible benefit of so-called "Lone Pine" orders to test the viability of novel nanotechnology-based toxic exposure claims. "Lone Pine" orders are derived from the case of Lore v. Lone Pine Corp., 1986 N.J. Super. LEXIS 1626 (N.J. Super. Law. Div. Nov. 18, 1986). Such orders, designed to require plaintiffs to make an objective showing early in litigation that there is sufficient evidentiary basis to warrant continued litigation, have been widely accepted and used in other federal and state courts throughout the country. To learn more, see Attorney DeVries' article on the subject: S. DeVries, et al., Use of Lone Pine Orders in Cost Effective Management of Mass Tort and Class Actions, 23 Toxics Law Reporter 1003 (Nov. 2008).

Devries can be contacted at SDeVries@winston.com for more information or a copy of his prior article above.

Source: BNA Toxics Law Reporter

Sweat The Small Stuff: An Introduction to Nanotechnology and Products Liability: Part 2 of 4

Tue, 09 Feb 2010 16:34:55 GMT

This is part two of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Nanotechnology promises to enhance existing technology in useful ways, and to make science fiction a reality. But, nanotech’s value must be weighed the consequences. Part 2 of this series explores the potential dangers of nanotech.

How Nanotechnology is Different than Naturally-Occurring Nanoparticles
Exposure to naturally occurring nanoparticles is not rare. Combustion typically produces some inhalable nanoparticles. Even most man-made nanoparticles, like those given off during industrial pollution, are not particularly dangerous in small doses. But, there is growing evidence that engineered nanoparticles are entirely different.

Naturally occurring nanoparticles and even anthropogenic nanoparticles that are byproducts of chemical processes are water soluble. The particles tend to agglomerate, naturally collecting and forming bigger substances. The human body is naturally prepared to deal with and filter out those particles. Because the particles are water soluble, they tend to dissipate quickly and are ultimately removed from the body.

In sharp contrast, Albert Lin notes “engineered nanomaterials tend to persist for longer periods as nanoparticles, thanks to special coatings designed to prevent agglomeration and to preserve the particles’ unique properties.” Engineered nanomaterials are designed to stay in their configuration which nullifies the body’s defenses. Additionally, virtually all the properties that make nanomaterials useful, also make them dangerous. Nanomaterials’ high surface area ratio and small size make them toxic because a high surface area corresponds to a greater number of “reactive groups” at the surface. Lin describes the impact - surface reactive groups “play an important role in toxic reactions by generating reactive oxygen species that may damage DNA, proteins, and cell membranes.” The size of nanomaterials allows them virtually unlimited access to the body’s systems and passageways, since natural filters are avoided. In fact, engineered nanomaterials can even penetrate the blood-brain barrier, meaning that the toxic materials could land themselves in the most sensitive area of the human body.

Studies of ambient ultrafine particles have shown that they are capable of causing serious health problems ranging from inflammation to heart attacks. It is unclear whether nanomaterials would cause the same problems, but it seems likely. The dangerousness of these small particles isn’t related to what they are made of or their mass, as much as the surface areas they present. At least one study concludes that nanomaterials may be worse. The study, published in Nanotechnology and the Environment, compared the effects of quartz dust, a serious occupational hazard, to carbon nanotubes. At least in mice, the study concluded that carbon nanotubes produce greater inflammation and more serious lesions.

Recent Study Links Nanotechnology to the Deaths of Two Factory Workers
Recently, nanomaterials were linked to the deaths of two Chinese factory workers and the severe injuries of several others. The women worked in a facility spraying a polyacrylic paste onto a polystyrene substrate. It appears that their ventilation equipment was damaged. The Chinese women have the dubious honor of being the first publicized deaths attributable to nanotechnology.

No scientists working with nanomaterials have yet manifested symptoms of disease related to nanoparticles. But there are problems with tracking illnesses that result from nanomaterials. Unfortunately, it is likely that negative effects are the result of cumulative exposure. Additionally, many people who work with nanomaterials probably are not aware of it. Finally, workers, consumers, and doctors likely have no idea what to look for since companies are not required to disclose the existence of nanomaterials and they are generally not discernible absent the aid of the most sophisticated tools.

Environmental Impacts
Nanotechnology could also have a dramatic effect on the environment at large. Nanomaterials are probably dangerous to other organisms for the reason they are dangerous to humans. One study (conducted by Eva Oberdorster) has linked nanomaterials to brain damage in bass. Microorganisms are particularly at risk, which is troubling because microorganisms are at the very bottom of the food chain.

Overall, the point is that while nanotechnology is very promising, it comes with risks. Unfortunately, the specific risks have not been readily identified. It is hard to say with any certainty which types of nanomaterials will cause problems or how the problems will manifest. Society at large is not in a particularly good position to monitor the effects, and we are all left waiting on underfunded and less than glamorous research to fill a serious void in our collective knowledge on the subject. At this point objective risk-assessment is difficult if not impossible. The question for products liability attorneys and risk managers is what to do in the mean time.

- Nick Dudley

Part 3 will suggest a strategy for products liability attorneys and nanotechnology insiders.

Sources:
-Swiss Re, Nanotechnology: Small Matters, Many Unknowns 13 (2004)
-The Royal Society & The Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties 5 (2004)
-Lin, Albert, Size Matters: Regulating Nanotechnology. Harvard Environmental Law Review, Vol. 31, 2007. UC Davis Legal Studies Research Paper No. 90. Available at SSRN: http://ssrn.com/abstract=934635
-Gunter Oberdorster et al., Nanotoxicology: An Emerging Discipline Evolving from Studies of Ultrafine Particles, 113 ENVTL. HEALTH PERSP. 832-3, 835 (2005)
-Andrew D. Maynard & Eileen D. Kuempel, Airborne Nanostructured Particles and Occupational Health, 7 J. NANOPARTICLE RESEARCH 587, 592-93 (2005)
-Chiu-Wing Lam et al., Toxicity of Single-Wall Carbon Nanotubes in the Lungs of Mice Exposed by Intratracheal Instillation, in NANOTECHNOLOGY AND THE ENVIRONMENT at 60-5.
-Berube, David, NanoHype: Nanotechnology Implications and Interactions http://nanohype.blogspot.com/2009/08/nanoparticles-responsible-for-deaths-of.html.
-Mark R. Wiesner & Vicki L. Colvin, Environmental Implications of Emerging Nanotechnologies, in ENVIRONMENTALISM & THE TECHNOLOGIES OF TOMORROW: SHAPING THE NEXT INDUSTRIAL REVOLUTION 41, 48-49 (Robert Olson & David Rejeski eds., 2005).
-Eva Oberdorster, Manufactured Nanomaterials (Fullerenes, C60) Induce Oxidative Stress in the Brain of Juvenile Largemouth Bass, 112 ENVTL. HEALTH PERSPECTIVES 1058, 1058-62 (2004)
-Gunter Oberdorster et al., Nanotoxicology: An Emerging Discipline Evolving from Studies of Ultrafine Particles, 113 ENVTL. HEALTH PERSP. 827 (2005).

The Rise of Nanotech Litigation

Wed, 03 Feb 2010 13:13:02 GMT

You may be interested in the cover article from the Winter 2010 Issue of the ABA Section of Litigation magazine, Litigation News – “The Rise of Nanotech Litigation.”

The article by Litigation News Associate Editor Kristine Roberts is, in my view, a substantially scaled down summary of a number of my previous articles on the subject, including "The Dawn of the Age of Nanotorts", published last year by BNA in three of its subject-matter reporters - Class Action Litigation, Toxics Law, and Product Safety & Liability.

I’m glad to see someone out there is reading.

Roberts also includes a few comments from Section of Litigation members on likely nanotech-related product liability and exposure litigation. Below are a few excerpts from the Roberts article.

Concern about potential risks has lawyers gearing up for nanotech suits
While no lawsuits have yet been filed, the government’s ongoing focus upon this emerging scientific area signals the potential for a flood of new tort claims.

The risks are unknown
The EPA’s new research strategy is indicative of the federal government’s increased attention to nanotechnology risks. The government’s focus on risk assessment also comes amidst criticism from advocacy groups, such as the International Center for Technology Assessment (ICTA). Just like product liability claims based upon exposure to asbestos or other chemicals, manufacturers and their counsel involved in nanotechnology need to “learn the science” underlying the specific “nano” molecules involved. Because engineered nano molecules have different properties than do “macro” molecules of the same substances, it is not clear whether the nano molecules would react differently in living things than do products made with macro molecules.

Concern rises even though risks are not quantified
Public opinion on nanotechnology reflects concern about possible risks. A survey conducted in September 2009 shows that many Americans are worried about the potential risks of nanotechnology and whether those risks will outweigh the benefits. A majority of those surveyed believe that there should be more federal oversight and regulation.
Product liability lawsuits asserting injury or harm from nanomaterials are likely to pose difficulties for companies that are unprepared because of the huge number of potential claimants and the long latency period between exposure to a nanomaterial and the onset of a disease allegedly related to such exposure.

Nanotechnology litigation may not be far off

Product liability and toxic exposure attorneys suggest that the first civil tort suits will be filed within the next five years. They anticipate a variety of claims, including consumer claims based on the fear of future physical harm. At issue could be whether manufacturers of consumer products appropriately tested nanomaterials, whether the government approved the product, and whether the potential harms were adequately disclosed. The attorney experts agree that employees of nanomaterial manufacturers are likely to bring exposure claims, and that theories applied to nanotechnology claims will include defective design, defective manufacturing, and failure to warn claims.

What can litigators do to stay on the forefront of this trend?
[Of course, they should be regular readers of www.nanotortlaw.com.]
Experts agree that whether you represent plaintiffs or defendants, it is critical to understand the science. Lawyers practicing in this area need to refresh their knowledge of physics and chemistry [assuming they ever had it to begin with, which excludes a large percentage of the practicing bar].

Carbon Nanotube Risk Questions Stir EPA Proposed Significant New Use Rule for Certain Multi-Walled Carbon Nanotubes

Wed, 03 Feb 2010 10:00:00 GMT

On February 3, 2010, the United States Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for certain multi-walled carbon nanotubes (MWCTs) for which it has already received a premanufacture notice. Manufacturers and importers of MWCTs would now have to notify the EPA if they plan to use the substance differently than outlined in their premanufacture submission.

The new proposed rule indicates the EPA’s belief that different uses than those described in the premanufacture notice could result in increased exposures, thereby constituting a new use. The EPA would want to assess and potentially regulate any such new use, prior to the proposed use occurring.

According to an article in today’s BNA Daily Environment Report, the EPA "has decided that use of the nanotubes without gloves and protective clothing, thereby creating the potential for exposure through the skin or by inhalation, may cause serious health effects. Serious health effects also could occur if the nanotubes are used without a National Institute for Occupational Safety and Health-approved full-face respirator with an N100 cartridge or if it is used in ways other than as described in the premanufacture notice."

The EPA is accepting comments on the proposed rule through March 5, 2010.

Sources: The Bureau of National Affairs' Daily Environment Report; Meridian Nanotechnology and Development News

Slack Nano Research Safety?

Tue, 02 Feb 2010 07:13:11 GMT

Many researchers working with nanomaterials use inadequate protection, if any at all, and most don't use special disposal methods for nanomaterials, claims a new study published January 2010 in Nature Nanotechnology. The study is discussed in a January 31, 2010, post by Kate McAlpine, at Britain's highly regarded Royal Society of Chemistry, Chemistry World website. www.rsc.org/chemistryworld/News/2010/January/31011001.asp

As most nations don't have specific regulations for nanomaterials, rules to protect researchers fall to individual institutions. Nearly half of the 240 respondents to a survey analysed by a team at the Nanoscience Institute of Aragon at the University of Zaragoza in Spain reported that no regulations were enforced by their institutions, and another 27 per cent were not sure.

Assessing risks posed by nanomaterials is a complicated matter, as the study authors themselves point out, because potential dangers depend on several factors including size, shape, chemical composition, and solubility. So far, most studies have focused on toxicity and mortality rather than the chronic exposure experienced by scientists in labs. Standard, acceptable levels of exposure have not yet been determined.

'We are nanotechnology researchers ourselves, and many times we are faced with the problem of how to handle our materials, how to avoid contamination, how to dispose of them, and so on,' says co-author Jesus Santamaria.

Among other questions, their survey asked a semi-random selection of nanomaterial scientists whether nanomaterials could become airborne during their laboratory's synthesis process. A little over half of the researchers said no, a quarter weren't sure, and 22 per cent responded that particles could become airborne.

Santamaria's team then asked about protective equipment - lab equipment such as local extraction or fume hoods, and personal protective wear, particularly face masks. Curiously, when it comes to laboratory safety, those who responded that particles could become airborne were similarly equipped to those who said no, with nearly 40 per cent using inadequate protection or none at all. Only about 10 per cent of the respondents who were aware of some risk of airborne particles used special filters in their fume hoods.

On the other hand, those who said particles may become airborne were twice as likely to wear a face mask, although two thirds of them wore either no mask at all or a mask with no filters. And while 81 per cent of the respondents believe that nanomaterial waste should be treated as hazardous unless proven otherwise, 85 per cent reported that they treat the disposal of these wastes as they would chemical waste, or they employ no special procedures.

'Even without knowing the nanospecific risks of airborne particles it should be clear to anyone that our lungs should be protected from the inhalation of any sort of particles,' says Samuel Halim, CEO of Swiss startup company Nanograde. In his experience, researchers are more cautious than the report suggests, though he also notes that risk awareness has increased significantly over the last decade.

Santamaria recognises that we inhale millions of naturally produced nanoparticles just by breathing ordinary air, and most nanomaterials are no more dangerous than other chemicals already in use. However, new materials with the ability to infiltrate cell membranes and even cell nuclei are currently under study, and he believes that now is the time to give precautions greater consideration.

Regulation
Governments are still wrestling with the regulation of nanomaterials. The UK and US have established voluntary systems to gather data from manufacturers - what materials they make, how much, and for what purpose - but the participation rate has been low.

Last year, Canada passed legislation to implement mandatory reporting, and earlier this month, US senators submitted a bill for the Nanotechnology Safety Act of 2010, which would provide $25 million (£15.5 million) per year for the assessment of health and safety of nanotechnology in everyday products and development guidelines for companies that use nanomaterials.

'As the scientific community investigates questions concerning toxicity, exposure, risk assessment, and medical health effects related to nanomaterials, the role of the Federal and State governments will become clearer,' says Sara Brenner, assistant vice president for nanohealth initiatives at the State University of New York State, US.

Sources: Royal Society of Chemistry; F Balas et al, Nature Nano, 2010 DOI: 10.1038/ nnano.2010.1

Sweat The Small Stuff: An Introduction to Nanotechnology and Products Liability: Part 1 of 4

Mon, 01 Feb 2010 16:10:30 GMT

Nick Dudley, a third-year law student at the University of Minnesota Law School, has prepared an interesting primer on nanotechnology and the likely effects on products liability litigation and risk management. This is Part 1 of 4.

What is Nanotech?
Nanotechnology refers to the science of manipulating particles at the nano scale. In other words nanotech is smaller than 100 nanometers, and a nanometer is one billionth of a meter. A nanometer is five times the size of a typical atom. Nanotechnology refers to a wide range of processes, manufacturing techniques, and potential applications; each of which is promoted by various government laboratories and corporate entities. So, defining nanotech is a bit like defining religion. No one organization has hegemony over the field. No one process defines the essence of the field.

How is Nanotech Different than Traditional Technology?
Nanotech can resemble traditional top-down engineering. Top-down engineering requires that the builder take something large and refine it into something small. Trees are turned into desks or pencils. Likewise, relatively large particles are pared down into nano-filaments. But nanotech can also be produced using bottom-up engineering. A bottom-up process can take something incredibly small (namely individual atoms) and make something much larger (but still imperceptibly small). It is like using atoms as Lego building blocks. Bottom-up engineering can be self replicating and is much more efficient.

Scientists and engineers make nanomaterials out of common chemical substances. However, these “everyday” substances behave remarkably different at nanosizes. Thus, carbon, an abundant and common element (indeed a building block of life itself) may be unremarkable when it is the size of a plant, or a single ash, or even in a molecule of carbon dioxide. But, at nanoscales, carbon can be engineered into a tube that is stronger for its size than any other substance humanity has discovered. Properties of materials are altered in strange and useful ways at the nanolevel because of a high surface area to mass ratio. According to Albert Lin, the “mechanical, electrical, optical, catalytic, and/or biological activity of a substance” is significantly enhanced.

Most nanotechnology can fit into one of three classifications: nanoscale engineering, productive nanosystems, and self-replicating nanotech. Nanoscale engineering is the most basic of the three types. It is used to create very small nanoparticles that can be free floating to create lubrication (think miniature ball bearings) or integral structures (carbon nanotubes). Productive nanosystems can be used as delivery mechanisms for pharmaceuticals or to make other nanostructures. That technology is in a developmental stage and in limited commercial application. Finally, replicating systems, which represent miniature versions of lathes and mills, could be used to self-replicate nanosystems and structures as needed. Replicating systems are still more theoretical than practical.

What will be the Economic Impact of Nanotechnology?
Nanotech is already on the market in a number of items including, stain resistant pants, sunscreen, pharmaceuticals, paints, electronics, tires, foods, and cosmetics. The technology is already fairly pervasive, but frankly the world has not seen anything yet. It is not hyperbole to call nanotechnology the foundation of the next industrial revolution. The United States government alone has spent roughly $1 billion on nanotechnology research and development, with private U.S. companies spending another $2 billion. The rest of the world has spent $9 billion. That may seem like a lofty investment, but it pales in comparison to the conservative projected return of $1 trillion. At least one firm has projected that by 2014, nanotech will account for $2.4 trillion in sales. As overwhelming as the projections seem at first blush, it is relatively easy to see how nanotech could account for such lofty numbers. Few technologies have the ability to touch every sector of an economy; but nanotech truly does, because it is a process as much as a product. Unfortunately, the potentially overwhelming benefits and pervasiveness of nanotechnology has led to a boom mentality among researchers. Very few people or institutions have been willing to pay the necessary cost of researching negative effects. Only 4% of the U.S. budget on nano research is directed towards potential health and environmental concerns. That has set the stage for a potential calamity.

- Nick Dudley

Part 2 will examine some of the real and potential dangers of nanotechnology.

Sources:
-The Royal Society & The Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties 5 (2004)
-Karluss Thomas & Philip Sayre, Research Strategies for Safety Evaluation of Nanomaterials, Part I: Evaluating the Human Health Implications of Exposure to Nanoscale Materials, 87 TOXICOLOGICAL SCI. 316, 316 (2005).
-The Royal Society & The Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties 5 (2004)
-Lin, Albert, Size Matters: Regulating Nanotechnology. Harvard Environmental Law Review, Vol. 31, 2007; at 5. UC Davis Legal Studies Research Paper No. 90. Available at SSRN: http://ssrn.com/abstract=934635
-President’s Council of Advisors on Science and Technology, The National Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National Nanotechnology Advisory Panel 1(2005)
-WASHINGTON POST, July 30, 2004, at A2
-Susan R. Morrisey, Nanotech’s Safety Risks, CHEM. & ENG’G NEWS, Dec. 5, 2005, at 46-48

The Nanotechnology Safety Act of 2010

Thu, 28 Jan 2010 18:01:44 GMT

On January 21, 2010, U.S. Senators Mark Pryor (D-AR) and Benjamin L. Cardin (D-MD) introduced The Nanotechnology Safety Act of 2010. The legislation aims to address potential health and safety risks about products that contain nanotechnology materials by establishing a program within the FDA to assess the health and safety implications of nanotechnology in everyday products.

The Nanotechnology Safety Act of 2010 also would support the development of best practices for companies who employ nanotechnology. To support these goals, the legislation authorizes $25 million each year from 2011 through 2015.

"Nanotechnology is one of the most important and enabling technologies being developed right now, and it has hundreds of promising applications - from new cancer treatments to improved military machinery to stain-resistant pants," Pryor said. "As these products are developed and used, we must understand any potential risks to human health, safety or the environment. My legislation will help ensure public safety and confidence in the marketplace, and it will support companies that employ nanotechnology materials."

"Nanotechnology touches so many facets of our lives today and will play a greater role in the future, but the benefits to industry and consumers come with unknown risks that must be identified and managed appropriately," said Cardin.

A statement concerning the legislation can be viewed at Sen. Pryor's website at the link below:

http://pryor.senate.gov/public/index.cfm?p=PressReleases&ContentRecord_id=92f252e2-7d7c-453d-8be8-f80c3f764ec8

Nano-Risks: A Big Need for a Little Testing

Fri, 08 Jan 2010 07:08:05 GMT

The editors of Scientific American write that the United States Environmental Protection Agency (EPA) must act swiftly to evaluate the possible health risks of nanotechnology.

Nanotechnology, they say, could emerge as an important tool to fight the threats of global warming and disease, but nanomaterials carry with them the potential for both good and harm. The editors applaud the EPA's recent announcement of a grand research strategy to study the health and environmental effects of nanomaterials, but add that speed is paramount. They cite the EPA's slow response to its directive to conduct a screening program for endocrine disruptors in the environment - 13 years from the directive to the commencement of research - as a farce that cannot be repeated. The editors say: "With so many nanomaterials already on the market and such little public awareness of nanotechnology, one safety scare might convince consumers that all nanotechnology is dangerous....In addition, without clear scientific and regulatory guidance, many companies are hesitant to invest in nanotechnology R&D, fearing the exposure to legal action that could result if one day a technology is deemed dangerous....This uncertainty is putting people's health at risk and choking innovation. And with all the threats the planet faces, we need all the little bits of innovation we can get."

The article can be viewed online at the link below.
http://www.scientificamerican.com/article.cfm?id=big-need-for-a-little-testing

Source: Meridian Nanotechnology and Development News

Tiny Objects, Big Concerns: A Risk Manager's Approach to Nanotechnology

Thu, 24 Dec 2009 08:33:09 GMT

"Tiny Objects, Big Concerns: Managing Nanotechnology Risks” , from the Claims Magazine, December 2009 issue, is wonderful reading to close out 2009.

Author Kevin Quinley has gravitas: over 30 years of experience in claims and a recognized insurance claim expert, trainer, author, and consultant. Quinley holds the CPCU designation as well as four specialty designations from the Insurance Institute of America: Claims (AIC), Risk Management (ARM), Management (AIM), and Reinsurance (ARe). He also serves on the Advisory Board of the Council of Litigation Management and the Insurance Institute’s Board of Ethical Inquiry.

To read the full article, see the link above.   But here is some of what Quinley has to say that this toxic exposure and nanotort lawyer/blawger finds to be great advice for risk managers, liability insurance professionals (both underwriting and claims), and their outside legal counsel.

“Nanotechnology could possibly translate into mega risks”

Occupational Hazards
One of the biggest areas of nanotechnology risk management concerns lies in workers’ compensation. Worries abound that employees working in manufacturing and industrial areas containing nanoparticles may inhale or absorb these particles and suffer adverse health effects. If this occurs, then serious workers’ compensation claims could follow. Experiments have shown that nanoparticles impact human tissue and cross the blood-brain barrier.
Workers’ compensation policies are statutory; that is, they cannot exclude benefits for claims arising out of exposure to nanotechnology or tiny particles. Certainly companies that manufacture nanotechnology or companies working with nano-tech materials may face heightened workers’ compensation risks, ratings, and costs.

In addition, the tiny nature of nanoparticles renders them highly reactive. This increases the potential for explosion, fire, and ignition. This can also create new workers’ compensation and environmental hygiene challenges.

Product Liability Perils
In addition to workers’ compensation exposures, product liability exposures loom. Thus far, companies have used nanoparticles in products such as solar panels, sunscreen, long-lasting cosmetics, and self-cleaning food containers. The use of nanoparticles in these and other products will likely increase over the next decade. One can readily imagine an influx of claims and lawsuits from plaintiffs alleging injury due to a supposed malfunction or defect in a nanotechnology product. Plaintiffs can assert defective design, defective manufacture, failure to provide adequate instructions or warnings, breach of implied or express warranty, and negligent marketing, among others. These are the same kinds of allegations that companies face in “macro” product liability claims. In other words, they are not unique to nanotechnology except insofar as the potential from loss because of inhalation or absorption of tiny particles that are later alleged to be harmful to public health.

Insurance Industry Responses
Insurance industry responses to nanotechnology perils are still embryonic. One reason is that many insurance companies have yet to assess the exposure. Loss data is either scarce or nonexistent. Thus, most of the insurance industry is in a study and analysis phase. Primary insurance carriers may insert exclusions in their general liability policies, precluding coverage for claims arising out of nanotechnology. Other potential insurance approaches would include deductibles for claims arising from nanotechnology or sub-limits applying to such claims. While primary insurance carriers formulate their own strategies, reinsurance companies are aware of nanotechnology risk. Some reinsurers may insert treaty exclusions precluding reinsurance coverage for nanotechnology claims.

From a risk management standpoint, risk managers must closely read their general liability policies to see if the latter contain exclusions that might render a nanotechnology claim uncovered.

Risk Management Strategies
Companies may apply a classic risk-management template to the perils arising from nanotechnology. This would include avoidance, retention, contractual transfer, and loss control.

    Avoidance - As the name implies, this would involve a company consciously deciding not to manufacture or use nanotechnology products. However, one need not be a manufacturer to face nanotechnology risks. Employees exposed to nanoparticles on-the-job may suffer health ills even if the employer is not a manufacturer.

    Retention - This occurs when companies enter nanotechnology and decide to self-fund for financial loss because of liabilities. Since quantifying such liabilities is challenging, because of the nascent nature of the risk, however, companies cannot credibly establish appropriate funding levels. The danger here is that ultimate liabilities might exceed retained funds and threaten an organization’s financial solvency.

    Contractual transfer – This arises when firms use insurance and noninsurance ways to cushion the financial risks and liabilities from nanotechnology. Insurance is a classic contractual transfer technique. Insurance does not transfer legal liability. Rather, it shifts the financial repercussions of nanotechnology liabilities to a professional risk-bearer. Non-insurance contractual transfer might include indemnification and hold-harmless agreements with business partners or component suppliers who are involved in nanotechnology.

    Loss control – It is essential to institute safety measures to minimize the frequency and severity of claims arising from nanotechnology. In a workers’ compensation and occupational health context, this could prompt firms to provide adequate breathing apparatus to employees to filter out the inhalation of nanotechnology particles. From a manufacturing perspective, it might involve a company fine-tuning its quality control and manufacturing process to ensure that any nanotechnology products pass all relevant governmental, regulatory, and safety standards.

Risk managers in a range of industries must stay attuned to the growth of nanotechnology and its attendant risks. The proverbial jury is out as to whether good things really do come in small (nano-sized) packages. Whether nanotech represents a scourge or a promising new business opportunity, risk managers must nevertheless anticipate both outcomes and prepare to use a variety of tools to keep nano-tech from becoming a mega-hazard to their organizations.

Source: Claims Magazine

A Skunk In The Box : Nanoparticle Toxicity

Tue, 22 Dec 2009 07:30:48 GMT

"Nanoparticles – one word: A multiplicity of different hazards"

That is the title of an Editorial written by twelve (12) leading nano-scientists from around the world and published in the December 2009 issue of the journal Nanotoxicology (December 2009, Vol. 3, No. 4, Pages 263-264). The Editorial was written to draw the attention of the nanotoxicology community to how the term "nanoparticles" is being used indiscriminately and misleadingly, particularly in the titles of scientific papers and statements to the general media. The authors are disturbed and concerned that the lack of precision can, and in fact already has, created dangerously misleading and unscientifically supportable overgeneralizations about nanoparticle hazards.

The nano-scientists’ concern, recast by me in terms lawyers well understand – is that of “putting a skunk in the jury box.” Once tainted or false information is publicized and has been consumed, especially if it is some of the first information received on a subject, it is very difficult to get people to forget the misleading or false information.

They cite, as a recent example, a paper that linked nanoparticles to seven very serious cases of occupational lung and pleural injury, two of which resulted in death, in China. (Song et al., 2009. Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma. Eur Resp J 34:559–567.) The research and related article received significant attention in scientific and even general media earlier this year, no doubt in part due to its title: "Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma."  The Editorial says that the title is dangerously misleading, and draws a link between generic nanoparticles and the observed effects. The title indicates that a new, causative link between nanoparticles and severe, even fatal, lung condition, has been identified. In fact, the nano-scientists argue, this conclusion is not scientifically supportable at all, is grossly premature, and will require significantly more study and concurring data to support such a link, if it exists at all.

After discussing the scientifically questionable aspects of the Song research and related published paper in more detail, the Editorial makes the following important observation:

"The scientific community is still learning how to best approach an understanding of the potential risks associated with new and emerging nanomaterials. Yet there is growing consensus that generic nanoparticles are not a toxicologically unique class of material, and that there is a danger of ill-informed studies slowing down scientific progress, while encouraging misinformed dialogue and decision-making."

The Editorial authors conclude by imploring that researchers in the nanotoxicology scientific community who publish and review papers on the human health impacts of engineered nanomaterials bear in mind the dangers described above and to:

    1.   Ensure that all descriptions of nanoparticle hazards recognize the intrinsic heterogeneity of the nanoparticle hazard and discuss the uncertainty of alleged causality;

    2.   Ensure that there is a convincing and scientifically sustainable link between any nanoparticle exposure and any pathological outcomes putatively associated with that exposure; and

    3.   Ensure that sufficient physical and chemical characterization data are provided on the nanoparticles in question to support valid data interpretation and comparison.

The Editorial authors, in alphabetical order:

Dr Rob Aitken
SAFENANO, Institute of Occupational Medicine, Edinburgh, UK

Professor Paul Borm
Hogeschool Zuyd, Heerlen, The Netherlands

Professor Ken Donaldson*
University of Edinburgh, Edinburgh, UK

Professor Gaku Ichihara
Nagoya University, Nagoya, Japan

Professor Steffen Loft
University of Copenhagen, Copenhagen, Denmark

Professor Francelyne Marano
Université Paris Diderot-Paris 7, Paris, France

Dr Andrew Maynard
Woodrow Wilson Centre, Washington DC, USA

Professor Günter Oberdörster
University of Rochester, Rochester, NY, USA

Dr Herman Stamm
European Commission Joint Research Centre, Ispra, Italy

Professor Vicki Stone
Edinburgh Napier University, Edinburgh, UK

Dr Lang Tran
Institute of Occupational Medicine, Edinburgh, UK

Professor Hakan Wallin
National Research Centre for the Working Environment, Copenhagen, Denmark

*Corresponding author

The Editorial can be viewed online at the link below:
http://informahealthcare.com/doi/pdf/10.3109/17435390903337701

Sources: Nanotoxicology, informahealthcare.com, Meridian Nanotechnology and Development News

Nanoparticles or No-No particles?

Wed, 16 Dec 2009 09:30:41 GMT

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.

Below are excerpts of the article, along with some additional relevant material.

Nanoparticles, hailed as the solution for everything from the next generation of micro-electronic gadgets to curing cancer, are poorly understood. When scientists first mastered the technology for creating and manipulating microscopic balls and tubes, toxicologists speculated that the tiny particles would have properties similar to the same chemicals on an every-day scale. Industry argued that nothing changed: For example, silver ions (the negatively charged silver atom, which is normally part of a silver salt) have been used for antibacterial purposes for years without major fish kills, so nanosilver should be fine, maybe even an improvement.

Tiny particles of silver – potent anti-microbial agents that can kill bacteria on contact – are becoming increasingly popular in consumer goods, including washing machines, refrigerators, clothing and toys. But as use of these microscopic silver particles grows, some scientists now are raising concerns about potential effects on the environment and human health.

Most of the silver nanoparticles used in applications like sunscreens, anti-odor treatments and filters are discharged into the environment as the product incorporating the nanosilver is used. The nanosilver cannot be treated by current wastewater handling systems, nor can it be detected by traditional analytical methods. Because nanosilver particles are not removed by current sewage treatment processes, they are discharged into lakes and rivers, where fish and other aquatic life are exposed. Research into the environmental implications of these silver nanoparticles has begun, but there are no answers yet about what happens when they enter ecosystems.

"'I think we jumped the gun' by creating such large volumes of nanoparticles," researcher Darin Furgeson, of the Nano Institute at the University of Utah, told Scientific American, in a November 2009 article “Fish Kill: Nanosilver Mutates Fish Embryos.” In one new experiment, Furgeson, a professor of pharmaceutical sciences, exposed zebrafish embryos to silver nanoparticles in a laboratory, and found that some died and others were left with dramatic mutations. "Some of the fish became extremely distorted, almost making a number nine or a comma instead of a linear fish," he said.

Is it the Nano or the Silver Causing the Damage?
That silver nanoparticles may be bad actors is not a big surprise to toxicologists. Silver has long been known to be one of the most toxic heavy metals in the aquatic environment. But, the mechanism of toxicity of silver ions, which disrupt the normal use of sodium and potassium ions for regulating biological functions, would not be expected from nanosilver, which is metallic and not ionic. Instead, nanoparticles seem to behave in new, unexpected ways: An earlier study conducted at the University of Singapore also found that silver nanoparticles disrupt the embryonic formation of the zebrafish, but that silver ions did not cause similar deformation.

The toxicity of silver nanoparticles is not due to the particle size alone though. The Nano Institute of Utah study found that silver nanoparticles disrupt embryo development but that gold nanoparticles do not. Conclusion: the problem is that nanosilver is both silver and nano. It is not enough to know how nanoparticles behave and how silver behaves to deduce the effects of nanosilver. Corollary: all new nanoparticles need a whole new set of research in order to understand potential new risks and new safety measures.

So Silver Nanoparticles are Regulated, Right?
Governments around the globe are juggling the questions of how to effective regulate potential nanoparticle risks without throwing up obstacles that could hurt their national competitiveness in this rapidly growing field. One major problem: most developed countries require industry to register any new "substances" before they start large scale production or sales. But many nanoparticles are just a different form of "existing substances" -- and therefore are not covered by existing laws.

This leads to the strange irony that new molecules such as carbon nanotubes or carbon fullerenes -- which have a chemical structure distinct from that of carbon in well-known substances such as coal or diamonds -- are regulated as "new substances." Their safety must be proven before they can be produced in industrial volumes. But under these laws, silver nanoparticles are treated like any other form of silver.

Consequently, industries using silver nanoparticles are invited by the U.S. EPA to participate in a voluntary Nanotechnology Stewardship program but have not yet been required to prove the safety of silver nanoparticles. In the meantime, EPA is using laws regulating pesticides to control consumer uses of the the antibacterial properties of nanosilver.

The challenge now is to gain the tremendous potential benefits of nanotechnology without entering a whole new era of environmental risks.

More on Nanosilver:

"More Nanosilver Cautions: British report Released October 26, 2009, Urges Government to Obtain Nanosilver Hazard Exposure Data"

"Demands for Ultra-Regulation of Nano-Silver : The First Battle for the Nanotechnology Industry's Future?"

"Nanosilver in consumer products: No silver lining for fish"

"Nano Silver in Your Underwear? 600 Products With Nanoparticles Are Barely Regulated"

"Silver Nanotechnologies and the Environment: Old Problems or New Challenges"

"New Biocide Research Pits Stinky Feet Against Fish"

"Beware The Silver Lining: A Risk Management Review Of Commercial Nanotechnology"

Sources: Discovery Communications, Scientific American

New Book: Environmental and Human Health Impacts of Nanotechnology

Tue, 15 Dec 2009 08:31:49 GMT

Need a holiday gift for your favorite Nanotechnophile?

Environmental and Human Health Impacts of Nanotechnology (J. Lead & E. Smith, eds., published by Wiley-Blackwell, October 19, 2009, 456 pp.) looks like a valuable resource for anyone keenly interested in nanotech environmental, health, and safety (EHS), whether academic researchers, scientists in industry, regulators, risk managers, or toxic exposure lawyers.

The book, available at Amazon.com, collects some of the latest information on environmental and health aspects of nanomaterials, discussing recent advances in the field and integrating knowledge from many different scientific disciplines. The introductory chapter provides an overview of the area and general context, ensuring the text is accessible for scientists and others who are not experts on in this area.

This book addresses the generic chemical aspects of nanoparticle properties, behavior, life-cycle analysis, ecotoxicity and modelling as these relate to their effects in the environment – aquatic, terrestrial and atmospheric - and humans. This information is critical for the development of appropriate evidence-based policy and guidelines for risk assessment of nanotechnology.

Topics covered include:

• The properties, preparation and applications of nanomaterials
• Characterization and analysis of manufactured nanoparticles
• The fate and behavior of nanomaterials in aquatic, terrestrial and atmospheric environments
• Ecotoxicology and human toxicology of manufactured nanoparticles
• Occupational health and exposure of nanomaterials
• Risk assessment and global regulatory and policy responses

The book concludes with a discussion on the worldwide regulatory and policy responses to nanomaterials. That is the least valuable discussion simply because changes in this area are occurring so frequently that the information will rapidly be obsolete.

From the Back Cover
Nanotechnology is a rapidly expanding field receiving extensive funding and development worldwide. A large number of novel processes occur on the nanoscale, and the unique properties of nanoparticles offer potential benefits in a range of applications, from consumer products to medicine and environmental protection. However, there remains considerable uncertainty with regard to the hazards and risks associated with nanoscience. An increased understanding of the environmental and human health impacts of engineered nanoparticles is essential for the responsible development of nanotechnology and appropriate evidence-based policy and guidelines for risk assessment.

Presenting the latest advances in the field from a variety of scientific disciplines, this book offers a comprehensive overview of this challenging, inter-disciplinary research area.

Understanding the behavior and impacts of nanotechnology in the environment and in human health is a daunting task and many questions remain to be answered.

Sources: Nanowerk.com, Amazon.com

EPA May Propose Two New Nanomaterial Rules in 2010

Fri, 11 Dec 2009 14:32:33 GMT

The United States Environmental Protection Agency’s (EPA) Regulatory Plan and Semiannual Regulatory Agenda, released on December 7, includes two potential new regulations aimed at gathering data on nanoscale chemicals.

New Reporting Requirement to Facilitate TSCA Application to Nanomaterials

The first possible regulation is a reporting requirement for certain nanoscale materials - that are unspecified - by June 2010. According to the agency, "[T]his rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume; methods of manufacture and processing; exposure and release information; and available health and safety studies. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA [Toxic Substances Control Act] to reduce any risk to human health or the environment."

Many nanomaterials are regarded as “chemical substances” under the TSCA. “Nanotechnology under the TSCA” describes the current approach to regulation of nanoscale materials under the Act. One of the key questions for manufacturers and importers is determining whether a given nanoscale material is already listed on the TSCA Inventory or if it is a new chemical requiring premanufacture notification to the Agency. EPA's TSCA Inventory Status of Nanoscale Substances – General Approach, describes the current thinking regarding whether a nanoscale material is a "new" or "existing" chemical substance under TSCA.

To complement and support EPA's new and existing chemical programs under TSCA, the Agency developed a Nanoscale Materials Stewardship Program (NMSP). The NMSP is intended to help provide a firmer scientific foundation for regulatory decisions by encouraging the development of key scientific information and to contribute to an improved understanding of risk management practices for nanoscale materials.

New Testing of Some Widely Used Nanomaterials

The second possible regulation would be a test rule for certain multi-wall carbon nanotubes (MWCNTs), along with nanoscale clay and alumina, by November 2010. EPA said that the results of such tests "would assist EPA in understanding the health effects of the substance to manage/minimize any potential risk and exposure. Results could also help with establishing a correlation bettering the chemical/physical properties and health effects needed to protect workers handling the substance."

Sources: EPA, Meridian Institute's Nanotechnology and Development News

Excellent Resource: First Global Nanotech Regulation Database Launched

Wed, 09 Dec 2009 12:44:29 GMT

The Center for the Study of Law, Science, & Technology (LST) at the Sandra Day O'Connor College of Law at Arizona State University, along with colleagues in Australia and Belgium, have launched the first global database of government documents on nanotechnology.

The web-based “Nanotech Regulatory Document Archive” is a natural fit for LST, which is housed in the first U.S. law school to offer a regular course in nanotechnology, has several faculty members who actively publish in the area, and has a cluster of law student researchers in the emerging technology. LST was assisted by the Centre of Regulatory Studies at Monash University Law School in Australia and the Institute of Environmental and Energy Law at K.U. Leuven in Belgium.

The LST Archive is a free resource that will enable government regulators, industry officials, lawyers, public-interest groups, and the public, to search for a variety of documents from every country in the world, and from every level of government. Its creation comes at a time when the worldwide regulation of nanotechnology is expected to ramp up considerably, in an attempt to keep pace with the science. According to Gary Marchant, LST's executive director, "[T]here's going to be a lot of activity in this area, and it's very important for people to be able to keep up. Every country is in the same place, going through the same steps, starting to put into place regulatory programs. We need to promote harmonization among these countries, and one way to do that is to have access in other jurisdictions, and to see what other people are doing."

The LST Archive is very user-friendly and intuitive. Documents for a specific jurisdiction can be accessed by clicking on a map or on a region, nation or entity. Withn the Archive, each entry provides a direct link and/or an attached copy of a specific document, an abstract of that document prepared for the database, and a listing of other pertinent information including author, date and document type.

The LST Archive website is also designed to operate as an edited Wiki, and users are urged to edit, add, delete and comment on the Web site.

If well-maintained, I expect the LST Archive will become an essential resource for the latest news on nanotechnology regulation and a great tool for researching and comparing regulatory approaches around the world.

The article, and a link to the database, can be viewed online at the link below.
http://www.law.asu.edu/?id=2122

Source:Arizona State University

NIOSH Nanotechnology Health & Safety Update: Updated, Enhanced Web Resources Posted 12/8/09

Tue, 08 Dec 2009 09:05:06 GMT

On December 8, 2009, the National Institute for Occupational Safety and Health (NIOSH) has updated and enhanced several web resources containing NIOSH’s research results and recommendations on the work-related health and safety implications of nanotechnology. NIOSH is the federal agency that conducts research and makes recommendations for preventing work-related injuries and illnesses.

The updated resources describe the latest scientific information available from NIOSH in its studies to help determine whether nanomaterials pose risks for occupational illness or injury. The enhancements are intended to help partners and stakeholders find information more easily and quickly.

“The body of scientific information on the health and safety implications of nanotechnology has grown substantially in the past five years, and continues to do so,” said NIOSH Director John Howard, M.D. “We are pleased to reflect this ongoing evolution of the science by regularly updating and augmenting the widely used and widely cited resources on our web page.”

The new web resources include these:

"Progress Toward Safe Nanotechnology in the Workplace," Publication No. 2010-104, is the latest updated edition of the cornerstone "Progress" document, first issued in 2007. The revised edition describes accomplishments in NIOSH’s research in the two years since the earlier version appeared. It includes updates on 43 projects by NIOSH scientists that address key areas of information needed for risk assessment, as well as updates on extramural research supported by NIOSH. In addition, it describes advances made under partnerships with 12 companies to assess potential exposures and control technologies in current work operations. The updated edition also discusses progress under NIOSH’s collaborations with other agencies and with standards-setting organizations in the U.S. and abroad.

"Strategic Plan for NIOSH Nanotechnology Research and Guidance," Publication No. 2010-105, similarly updates NIOSH’s roadmap for advancing knowledge about the implications and applications of nanotechnology. The Strategic Plan, developed with input from a broad range of stakeholders, was first issued in 2005. The new update discusses research planned by NIOSH for the period 2009-2012 in critical areas for filling current gaps in knowledge. A key feature of the plan is the alignment of critical research areas with the four strategic goals of the NIOSH NanoTechnology Research Center and the National Nanotechnology Initiative’s priority environmental health and safety (EHS) areas. The document accounts for key stakeholder input, partner involvement, and interagency collaboration.

NIOSH redesigned and reformatted its web topic page on nanotechnology to highlight links for specific audiences -- occupational safety and health practitioners, researchers, employers and workers, and policymakers and media. While users will continue to have access to all of NIOSH’s reports, publications, and recommendations that are posted on the web page, the links are designed to help different audiences more quickly and easily find the information likely to be of greatest immediate interest to them.

NIOSH provides a web link to the Nanoparticle Information Library, which is currently hosted, maintained, and administered by Oregon State University. Originally developed by NIOSH in prototype form, the Library is designed to meet global needs of researchers and others to find published studies and data, share knowledge, and make new professional contacts.

The new resources reflect NIOSH’s commitment to reviewing and revising its strategic planning, recommendations, and documents on an ongoing basis, to reflect advances in the science. Another cornerstone NIOSH document, "Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials," originally issued in 2006, was updated earlier this year.

Source: NIOSH

New Research: Widely Used TiO2 Nanoparticles Cause Systemic Genetic Damage in Mice

Thu, 03 Dec 2009 13:47:54 GMT

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.

Titanium dioxide (TiO2) Is Big Nanobusiness

The manufacture of Titanium dioxide nanoparticles is a huge industry and TiO2 nanoparticles can already be found in numerous consumer products in widespread use. In addition to paint, cosmetics, sunscreen and vitamins, the nanoparticles can be found in toothpaste, food colorants, nutritional supplements and hundreds of other personal care products. These nanoparticles have previously been considered to be safe and non-toxic because titanium is chemically inert and does not incite a chemical reaction.

Surprising Mechanism of Toxicity

But the UCLA study found that, once in the system, the TiO2 nanoparticles accumulate in different organs because the body has no way to eliminate them. And because they are so small, they can go everywhere in the body, even through cells, and may interfere with sub-cellular mechanisms. In the simplest terms, the TiO2 particles wander throughout the body causing oxidative stress, which can lead to cell death. Specifically, the UCLA study found that TiO2 nanoparticles induced single- and double-strand DNA breaks and also caused chromosomal damage as well as inflammation, all of which increase the risk for cancer.

According to study leader Professor Schiestl, it is a novel mechanism of toxicity – a physicochemical reaction – that the TiO2 particles caused in comparison to regular chemical toxins, which are the usual subjects of toxicological research. According to Professor Schiestl, "[T]he novel principle is that titanium by itself is chemically inert. However, when the particles become progressively smaller, their surface, in turn, becomes progressively bigger and in the interaction of this surface with the environment oxidative stress is induced. This is the first comprehensive study of titanium dioxide nanoparticle-induced genotoxicity, possibly caused by a secondary mechanism associated with inflammation and/or oxidative stress. Given the growing use of these nanoparticles, these findings raise concern about potential health hazards associated with exposure."

Real-world Implications?

The mice were exposed to the TiO2 nanoparticles in their drinking water and began showing genetic damage on the fifth day. The human equivalent is about 1.6 years of exposure to the nanoparticles in a manufacturing environment. "These data suggest that we should be concerned about a potential risk of cancer or genetic disorders especially for people occupationally exposed to high concentrations of titanium dioxide nanoparticles, and that it might be prudent to limit their ingestion through non-essential drug additives, food colors, etc.," the study states.

Sources: AZoNano.com

New Research: Nanomaterials Can Pass through Placenta

Tue, 01 Dec 2009 13:39:20 GMT

A new research paper, "Barrier Capacity of Human Placenta for Nanosized Materials," published November 12 in peer-reviewed journal Environmental Health Perspectives, establishes that some nanomaterials may pass through the transplacental barrier, raising the specter of risk from nanoparticle exposure in-utero.

Background
Humans have been exposed to fine and ultra fine particles throughout history, primarily as byproducts of natural phenomenon or combustion processes. But only recently has there been exposure to engineered nanoparticles with novel physical and chemical properties. In recent years there has been a growing concern about the possible health influence of exposure to air pollutants during pregnancy, hence an implicit concern about potential risk for nanoparticle exposure in-utero. The team of 10 Swiss researchers decided to investigate whether engineered nanoparticles could pass through the placenta for several reasons:
    1. airborne ultrafine particles are similar in size to some engineered nanoparticles and have been shown to affect the fetus;
    2. people are expected to have engineered nanoparticles injected into them for medical purposes, such as vaccinations and other nanoceuticals; and
    3. previous research has not addressed the question of whether engineered nanoparticles can cross the placenta.

The Study
The research team used the ex-vivo human placental perfusion model to investigate if certain engineered nanoparticles can cross this barrier and if this process is particle-size dependent. Fluorescently labeled polystyrene beads with a diameter of 50, 80, 240 and 500 nm were chosen as model particles. The results: polystyrene particles up to a diameter of 240 nm were taken up and were able to cross the placental barrier.

Conclusion
Some nanomaterials have the potential for transplacental transfer, underscoring the need for further nanotoxicological studies on this important organ system.

The article, and a link to the journal, can be found online at the link below.
http://ehp.niehs.nih.gov/docs/2009/0901200/abstract.html

Future Nanotorts Litigation : Part 3

Wed, 25 Nov 2009 16:11:48 GMT

Part 1 of the discussion examined the structural and systemic forces in the American tort system that will lead to the reality of nanotechnology-focused tort claims in the near future. In Part 2, I began to discuss some specific claims that are likely in early nanotort litigation, including medical monitoring claims. Here, in Part 3, I continue that claim-specific discussion, with a focus on possible class action claims.

Traditional Toxic Exposure Class Action Claims
For those hoping to pursue mass tort class action claims in the nanotechnology realm, the challenge is extremely steep. Class certification requires the showing that common issues of fact and law predominate over individual issues of fact and law. Such a showing will be almost impossible for nanomaterial exposure claims because issues of individual plaintiff exposure, dose, medical history, causation, and damages will predominate. Despite the difficulty of class action certification in the mass tort/toxic exposure area, plaintiffs have had some pockets of success that may apply to the nanotechnology context.

For example, class certification may be achieved if an action is divided into phases that allow for class-based litigation of some issues involving issues of common proof (e.g., negligence, whether product was unreasonably dangerous, failure to warn, entitlement to punitive damages), while providing for determination of individual liability and compensatory damages in separate phases. Class certification has also recently been affirmed in the context of medical monitoring claims, in those jurisdictions recognizing such claims in the absence of a present physical injury. In such cases, because individual class members need not prove an actual injury, the courts have been more inclined to find that the key issues are matters of common proof. These are narrow exceptions to the trend against class certification in cases alleging personal injury or some adverse health impact.

“No Injury” Consumer Class Action Claims
For the reasons already described, although more aggressive claimant counsel can be expected to try and push the legal envelope with novel legal arguments where nanomaterial exposure is alleged, it is unlikely that nanotort cases alleging traditional toxic exposure personal injury, especially class action suits, will be successful unless and until a signature illness or condition is discovered. Meanwhile, more probable nanotort litigation is pursuit of so-called “no injury” or “fraud light” claims. Pursued primarily as class actions, these cases have sprung up in the past decade in direct response to the increasing difficulty with proving personal injury in the mass tort and exposure context and the problems of obtaining class certification. Typically brought pursuant to state consumer protection statutes, these claims do not allege any personal injury at all; rather, they seek only economic damages in the form of a refund of the product purchase price. Seeking only an economic remedy avoids almost all of the difficult causation issues. In addition, the state consumer law statutes at issue typically do not require all the elements of common law fraud, e.g., proof of actual reliance by a particular plaintiff. The elimination of that individual issue of fact, combined with the elimination of difficult-to-prove individual personal injury causation, makes class certification and summary judgment survival more plausible.

For example, such a claim may be made on behalf of all purchasers of an existing nanoconsumer product – such as a cosmetic or sunscreen using nanoparticles – claiming that the manufacturer failed to label the product as containing nanoparticles, failed to warn about possible adverse latent health risks of nanoparticles, and thus misrepresented the risk of injury from use of the product. Some courts may allow such a claim to proceed if claimants’ attorney is armed with an expert witness and a study or two that suggests an increased risk from exposure to relevant nanoparticles – including those that may be prepared more or less specifically to support litigation. The economic risk to the defendant manufacturer of potentially refunding the purchase price for thousands or tens of thousands of claimants may be unacceptable high, depending on the parameters of the scenario, and a large class settlement may be extracted.

Conclusion
Nanomaterials have special properties and present the promise of untold benefits to mankind, but with resultant risks that are still largely unknown and, in all likelihood, unknowable until time passes and doors unknown in 2009 are opened as part of the inevitable scientific recursive. In the absence of legislative or regulatory action not yet contemplated, the revolutionary changes expected to be brought about by nanotechnology will play out within the established framework of American tort liability law that has accommodated and addressed every emerging technology of the past.

Litigating nanotechnology-related claims will require that judges and lawyers become much more sophisticated con¬sumers of science. The important role played by mass tort and toxic exposure lawyers in the realms of nano-risk perception and in nanotort litigation will significantly impact the degree to which the fantastic economic and societal benefits of nanotechnologies are realized.

NIEHS Awards Recovery Act Funds to Focus More Research on Health and Safety of Nanomaterials

Fri, 20 Nov 2009 08:13:01 GMT

On November 19, 2009, the United States National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, announced that it is increasing its investment in understanding the potential health, safety and environmental issues of the nanoparticles used in everyday products. The NIEHS press release can be viewed online at this link: http://www.niehs.nih.gov/news/releases/2009/nanotech.cfm

The NIEHS awarded 13 new two-year grants, through the American Recovery and Reinvestment Act, to bolster the NIEHS’s ongoing research portfolio in the area of engineered nanomaterials (ENMs). All 13 grants are aimed at developing reliable tools and approaches to determine the impact on biological systems and health outcomes of engineered materials.

"We currently know very little about nanoscale materials' effect on human health and the environment," said Linda Birnbaum, Ph.D., director of the NIEHS and the National Toxicology Program (NTP). "Nanomaterials come in so many shapes and sizes, with each one having different chemical properties and physical and surface characteristics. They are tricky materials to get a handle on. The same properties that make nanomaterials so potentially beneficial in drug delivery and product development are some of the same reasons we need to be cautious about their presence in the environment."

"There are inconsistencies in the biological effects of ENMs reported in the scientific literature, and a major reason for this is lack of detailed characterization of the physical and chemical properties of the ENMs used in these studies," said Sri Nadadur, Ph.D., program administrator at the NIEHS. "One of our goals is to identify three or four reliable and reproducible test methods using the same ENMs by investigators across different labs." To accomplish this, the NIEHS brought 36 investigators together on Oct. 20, 2009 in North Carolina, where the NIEHS is headquartered, to identify ENMs, assays and test systems to be utilized in these investigations in a more coordinated and integrated effort.

The NIEHS is establishing an integrated program that will narrow its focus to identify the best methods to evaluate the health effects of nanomaterials through use of cell cultures and animal systems. After the initial meeting, grantees will meet face-to-face twice a year to share information, evaluate progress and determine next steps.

In addition to Recovery Act funding, the NIEHS supports grantees across the country working on issues related to nanotechnology. The NIEHS extramural activities are focused on three main areas:

• The application of nanotechnologies in environmental health research through use of nanomaterials to improve measurements of exposure to other environmental factors, enabling research into the biological effects of exposures and improving therapeutic strategies to reverse the harmful effects of environmental exposures.

• Understanding the risks associated with accidental or intentional exposure to nanomaterials.

• Through the Superfund Research Program which authorizes NIH to fund university-based research to conduct the science needed for human health risk assessment and decision-making for remediation of hazardous waste sites, researchers across the country are looking at both the application of nanomaterials for environmental monitoring and remediation, and the health implications associated with their application.

On November 4, 2009, the NIEHS also announced a new funding opportunity to address the potential health implications of ENMs. The "Request for Applications entitled Engineered Nanomaterials: Linking Physical and Chemical Properties to Biology" can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-09-011.html

Are Early Nanotoxicity Tests Valid? Researcher Suggests Any Desired Result Can Be Produced About Nanomaterial Toxicity

Wed, 18 Nov 2009 07:30:36 GMT

A speaker at the workshop "Nanomaterials and Human Health & Instrumentation, Metrology, and Analytical Methods," being held this week as part of the White House's National Science and Technology Council, said, in a talk he meant to be provocative, that researchers can use cellular tests to obtain any result they want concerning the toxicity of a nanomaterial.

The speaker, David Grainger, chairman of the department of pharmaceutics and pharmaceutical chemistry at the University of Utah, in referring to in vitro toxicity tests, said "[Y]ou can find any answer you want. Is a carbon nanotube toxic? Yes. Is a carbon nanotube non-toxic? Yes." In vitro toxicity tests have been used as the standard test for nanomaterial toxicity due to animal welfare concerns. Grainger said that the ability of in vitro tests to predict nanotoxicity is really unkown, because so little is known about the way nanomaterials interact with cell culture and about what a particular test can predict.

Wow. But not really surprising if you understand the true infancy of nanotoxicity and accept that old methodologies and measurement techniques may need to be revised when studying the new classes of materials at issue - the likes of which have never before been encountered in the macromaterial world we have lived in to date. The takeaway? Neither insurers, risk managers, nor lawyers should make too much of any of the early in vitro, cellular impact studies done for various nanomaterials. They are certainly worth watching, but their value is very limited given the infancy of the field.

Future Nanotorts Litigation : Part 2

Mon, 16 Nov 2009 11:03:37 GMT

The sophisticated toxic tort/mass tort bar understands that the current high level of scientific uncertainty about nanoparticle risk makes it near-impossible to meet the burden of proof of causation – general and specific – recognized in both federal and state courts in the context of toxic exposure personal injury and wrongful death claims. The science needed to assess hazards of nanomaterials in the fields of toxicology, epidemiology, and industrial hygiene, let alone meeting the standards for admissibility of such scientific evidence under Daubert, is likely to be many years in the making. But there are still some early nanotort options.

Medical Monitoring Claims
One area of possible early nanotort activity, because it has the potential to avoid some of the stringent causation problems described above in some jurisdictions, concerns medical monitoring claims. Medical monitoring claims – recognized in some, but not all, jurisdictions – are divided into two types: jurisdictions requiring present physical harm and those with no present physical harm requirement. For those jurisdictions with a present physical injury requirement, the burdens described above for nanoexposure claims are essentially the same, making it very difficult for plaintiffs to succeed in exposure cases.

One expects that good lawyers representing claimants will attempt to overcome or sidestep some of the current hurdles by making novel arguments about what constitutes a “physical injury,” especially in cases alleging nanomaterial exposure. Arguments will be made that exposure to novel man-made nanomaterials requires fashioning of new law based on the unique biological issues presented by nanomaterials that have no precise legal analog. For example, will unwanted nanomaterial exposure be sufficient to prove an injury where it can be shown to have created subclinical, cellular, and/or subcellular changes, but without any diagnosed disease process? Will proof of bioaccumulation of nanomaterials in specific organs be sufficient?

The recent toxic exposure case of Parker v. Wellman, 230 F. App’x 878 (11th Cir. 2007), gives a glimpse of how such novel arguments may be pursued. Parker also previews the difficulty that will be presented by novel nanotort litigation when legal line drawing must take place where the line between science and the law is blurry. The Parker plaintiffs made a claim for medical monitoring due to alleged beryllium exposure. Parker applied Georgia law holding that proof of a present physical injury is required for such a claim. Plaintiffs argued that subclinical, cellular, and subcellular damage existed and could satisfy the physical injury requirement. The Eleventh Circuit used science as a tool but ultimately was required to make a non-scientific judgment because “present physical injury” is a term of legal, not scientific, art in the context of tort litigation. So, while it may be scientifically true that exposure to a substance has in fact caused some biological change or damage, e.g., cellular damage or immune system response, the legal question is more ambiguous: is that level of harm or damage sufficient to constitute a present physical injury as that legal term of art is defined by evolving common law. The difficulty of such science/law decisions is reflected in the Parker case holding: the plaintiffs’ subclinical damage claims did not meet the present physical injury requirement, however the court remanded the case for a further determination whether plaintiffs’ claim of “beryllium sensitization” might be considered a present physical impairment.

A discussion of novel and controversial injury theories advanced by some alternative medicine practitioners is beyond the scope of this discussion, but the complexities, unknowns, and fear perception raised by nanotechnologies makes nanoparticle exposure almost certain to be a target of practitioners in fields such as “environmental medicine” and so-called “complementary and alternative medicine.” Many of those practitioners staunchly advance an agenda that exposures to many common substances are toxic, and various nonspecific ailments and negative health conditions are caused by such exposures, such as multiple chemical sensitivity, chronic fatigue syndrome, attention deficit disorder, muscle and joint pain, cardiovascular disease, hormone imbalance, and a variety of other syndromes and “ailments of unknown etiology.” Arguments that exposure to new man-made nanoparticles triggers such disorders and ailments can be expected, which will focus much more attention on the scientific validity of those unconventional medical fields and controversial ailments than they have received so far.

For those jurisdictions that do not require proof of a present physical harm, an increased risk of harm is sufficient to justify a medical monitoring claim. Courts are further divided as to the extent of the increased risk necessary to support a claim for medical monitoring. It is on this last point that the lack of hard science establishing a link between exposure to a specific nanomaterial and increased risk of any particular illness or disease process can prove legally fatal, even for a medical monitoring case in a “no present injury” jurisdiction. Nevertheless, the advent of tort litigation concerning nanomaterials that have no precedential risk assessment in science or the law creates the opportunity for claimant attorneys to press for new ways of assessing what constitutes harm and relevant risk. That legal ground is still unplowed.

In Part 3, I will continue the discussion of specific types of claims that are most likely to be at the leading edge of nanotorts litigation.

EU Launches New Nanotechnology Consumer Product Inventory

Fri, 13 Nov 2009 08:37:57 GMT

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. The organizations published a joint position paper in June 2009, voicing concerns about the safe development of nanotechnology-enabled consumer products: Nanotechnology: Small is beautiful but is it safe?. It is worth a read.

The inventory when launched contained only 151 products, but the organizations caution that the list is not exhaustive and should only be considered an overview of what consumers can find in the EU. The inventory covers categories including computers, flooring, household appliances, garden products, children's products, and healthcare. The organizations say they plan to regularly update the inventory, which is available free of charge on their respective websites.

The two organizations, in conjunction with the launch of the inventory, also made a series of demands for the regulation of nanotechnology:

• Clear definitions of nanomaterials and nanotechnologies to guarantee legal certainties and allow the development of regulatory requirements;

• The application of the precautionary principle in the field of nanotechnologies;

• The assessment of the safety of nanomaterials by independent scientific bodies before they can be used in consumer products with which consumers come in direct, close or frequent contact (including cosmetics, food and clothing) or in products that could potentially harm the environment;

• Adequate safety and risk assessment methodologies taking account of all characteristics of nanomaterials;

• The adaptation of existing European legislation relevant to nanomaterials or the development of new legislation in order to safeguard consumer health and safety, and the environment;

• The establishment or adaptation of legal requirements related to health and safety (e.g. limit values for certain nanomaterials in products);

• The establishment of a public inventory of products that contain nanomaterials to ensure transparency about the use of nanomaterials;

• The labeling of consumer products containing nanomaterials, in particular products with which consumers come in direct, close or frequent contact such as cosmetics, food products and clothing;

• Effective participatory processes in order to allow citizens to fully engage in technological developments which will have an impact on their everyday lives.

Sources: BEUC and Nanowerk

New UK Nanoparticle Risk Study Center Opens

Thu, 12 Nov 2009 07:49:20 GMT

A new UK-based nanoparticle risk research center was launched this week.

Edinburgh (Scotland) Napier University's new Centre for Nano Safety has been set up to identify whether a variety of nanoparticles can enter the human body – as well as other species such as bacteria, insects and plants – and cause harm. The Centre's mission is to study the possible toxicity of nanoparticles, both biotoxocity and ecotoxicity.

Professor Anne Glover, chief scientific adviser for Scotland, said: "Given the widespread use of nanomaterials, it is essential for us to fully understand them and their potential impacts."

Information that the Centre develops will be used by industry and by British government agencies to develop appropriate regulations. Parliament may also use the Centre's research as a basis for legislation affecting nanotechnology research and nanoindustries.

Source: Edinburgh Evening News, November 11, 2009
Location: Edinburgh, Scotland

Future Nanotorts Litigation : Part 1

Mon, 09 Nov 2009 07:50:33 GMT

No one knows yet whether nanotechnologies will be shown to have harmful consequences or whether they present only phantom risk. Although only tentative, some early studies suggest that some nanoparticles may have negative health and environmental consequences. Experience teaches that when there are concerns about possible health and safety hazards, litigation – feeding on public and political risk perception – is never far behind.

Nanotorts are a virtual certainty, despite the current uncertainties of nano-related health and environmental hazards. History teaches that new technology breeds new litigation. The life of tort law in the United States over the past century demonstrates a repeating pattern which will be applied in the future to the various industries incorporating nanotechnologies. The pattern: (1) “old technologies” are phased out of common use and concomitant litigation targets no longer yield claims; (2) “new technologies” arise and the tort bar demonstrates adaptability in identifying new, replacement litigation targets; and (3) repeat steps 1 and 2. And it has been the case that tort lawsuits in toxicity and biological areas in particular have tended to get ahead of the science or proceed in the face of it, especially where sufficient political and public risk perception exists.

The question is not if, but when, nanotort claims and litigation will arise. Why? Because a large, well-financed mass tort infrastructure is in place. That mechanism, financed initially by tobacco and asbestos litigation, has been used with some success for other target substances such as lead, benzene, silica, welding fumes, medical devices, and pharmaceuticals. This mass tort infrastructure consists of two equally important and sophisticated parts: (1) the creation and management of public and political risk perception, and (2) the pursuit of litigation. Well-honed on other substances, both aspects are well suited to exploit the Age of Nanotechnology.

When nanotort claims are made, they can be expected to cover the full range of tort litigation: both individual and mass tort/class action personal injury; workers’ compensation; environmental contamination/cleanup; consumer protection; and property damage.

In Part 2, I will discuss some specific types of claims that I believe are most likely to be at the leading edge of the nanotorts litigation wave when it arrives.

Can Medical-Device Nanoparticles Inflict Harm Across Cell Barriers?

Fri, 06 Nov 2009 09:30:02 GMT

A new study was published on-line November 5, 2009, in Nature Nanotechnology with a provocative title: Nanoparticles can cause DNA damage across a cellular barrier.

The study was led by a team from the Bristol Implant Research Centre, UK, and raises some concern over the safe medical use of nanoparticles. The nanoparticles studied were cobalt/chromium alloy nanoparticles – because these are created in small amounts when artificial joints wear during use. The research shows – in a lab situation not designed to accurately replicate conditions in the body – that high doses of the CoCr nanoparticles can cause measurable damage to the DNA in human fibroblast cells (cells important in wound healing) across an intact cellular barrier without actually crossing the cellular barrier.

So how was the DNA in the fibroblast cells damaged without any direct exposure to the nanoparticles? This is the part that is likely to whet the appetites of other scientists and lead to more research. The study found that while the nanoparticles did not pass through the cell walls, they generated novel signalling molecules that were then transmitted to the fibroplast cells on the other side. As the study team reported: “The outcome, which includes DNA damage without significant cell death, is different from that observed in cells subjected to direct exposure to nanoparticles. Our results suggest the importance of indirect effects when evaluating the safety of nanoparticles. The potential damage to tissues located behind cellular barriers needs to be considered when using nanoparticles for targeting diseased states.”

The authors of the paper conclude: “We suggest that an evaluation of nanoparticle safety should not rely on whether they fail to gain access to privileged sites. Instead there should also be an evaluation of their genotoxic potential for both direct and indirect effects to avoid any potential risks to targets on the distal [far] side of cellular barriers.”

So what does this study mean? According to Andrew Maynard, a Nanotechnology risk expert from the Woodrow Wilson International Center for Scholars in Washington, DC: “It's an important study as it raises possible new ways in which harm could occur following exposure. But while it raises new questions, it is far from conclusive on whether this is a relevant or significant way in which specific types of nanoparticles can cause harm. More research is needed.” I couldn't have said it any better myself.

More details on the study's relevance can be found at http://2020science.org/2009/11/05/could-nanoparticles-inflict-harm-across-tight-cellular-barriers/

This post is based, in part, on information from a post by Katharine Sanderson at the Nature science blog, The Great Beyond

More Nanosilver Cautions: British Report Released October 26, 2009, Urges Government to Obtain Nanosilver Hazard and Exposure Data

Tue, 03 Nov 2009 12:29:46 GMT

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.

Nanosilver Widely Used in Consumer Products

A bit more on the Report but first a digression. Silver nanoparticles are already used in more consumer products than any other nano-material, primarily because nano-silver is a highly effective bactericide and anti-microbial. For example, nano-silver is already in use in home appliances, infant cups and utensils, food packaging, water filters, socks, bedding materials, undergarments, and other products. In particular, clothing that stays odor-free thanks to antimicrobial nanosilver is becoming more abundant. But what happens to the silver when the clothing is washed? Research into the behavior of commercially available nano-silver textiles under real-world washing conditions shows that nanosilver particles leach from clothes during washing, and into wastewater streams. L. Geranio, et al., "The Behavior of Silver Nanotextiles During Washing," Environ. Sci. Technol., 43 (21) (September 2009) and "Toxic Socks: Silver nanoparticles intended to control odor release in the wash," Chemical & Engineering News, (April 14, 2008).

Nanosilver Risk Evidence

Without question, some early studies have found likely nanosilver ecotoxicity as well as biotoxicity to some fish and acquatic non-vertebrates. Concerns also appear founded that ever-expanding use of nano-silver in consumer products will cause increased silver wastewater discharges, leading to the potential for adverse environmental and biological impacts as yet unknown. For a more robust background, which also calls for urgent research, read S. Luoma, "Silver Nanotechnologies and the Environment: Old Problems or New Challenges," PEN 15, Sept. 2008. In my Post on October 20, 2009, I discussed the alarmist view of nano-silver voiced by some special interest groups, Demands for Ultra-Regulation of Nano-Silver – The First Battle for the Nanotechnology Industry’s Future?

"Report on Nanosilver"

Back to the Defra Advisory Committee on Hazardous Substances “Report on Nanosilver.” The Report observes that nanosilver is already widely used in common consumer products such as cosmetics, fabrics, toothpaste, toothbrushes, kitchen surfaces, bandages, medical equipment and other products, and recognizes research showing that nanosilver particles are released from commercially available products.

"The likely wide use of consumer products using nanosilver as an antibacterial agent suggests wide environmental exposure" and "[e]xposure to humans is likely to be high in certain groups, due to their use in a wide range of products." The Report finds that "the nature of the environmental risk associated with the widespread use of nanosilver products is poorly characterised due to lack of knowledge." And regarding human health effects, the Report suggests that silver resistance by bacteria and possible increased antibiotic resistance due to nanosilver "has the potential to be deleterious to human health and should be investigated."

The Report concludes by recognizing that "[f]urther knowledge on both hazard and exposure is urgently required" and identifies as "immediate priorities" the need to develop methods to measure nanosilver in the environment, understand how it is transported through the environment and whether it persists, and to determine its biological effects (bioaccumulation, toxicty) under real-world conditions.

The drumbeat concerning nanosilver risk continues.

This Post is based, in part, on information from The Bureau of National Affairs' Daily Environment Report and Meridian Institute's Nanotechnology and Development News service. To learn more about Meridian Institute's nanotechnology projects, visit http://www.merid.org/nano.

Rapid Nanotechnology U.S. Patent Growth Portends Future Risk Management Challenges

Mon, 02 Nov 2009 08:23:37 GMT

Don’t look now, but the U.S. is on pace to grant more than 4400 patents related to nanotechnology in 2009, an almost 50% jump from 2008, itself a record year. U.S. nano patent facts evidencing the rapid acceleration in commercialized nanotechnologies:

• In 2009, through November 1, 3735 nano related U.S. patents have been granted, an average of more than 370 per month (12 per day)

• Through November 1, 2009, a cumulative total of 20,459 nano related U.S. patents have been granted; almost half of which have been granted just in 2007-2009

• There are more than 39,000 nano related patent applications pending.

Source: Alton Parrish. Parrish is a senior Analyst for Innovative Research and Products and maintains a blog on nanotechnology at http://nanopatentsandinnovations.blogspot.com/

A Global Perspective on Safe Nanotechnology: The XVIII World Congress on Safety and Health at Work

Wed, 28 Oct 2009 14:11:30 GMT

A symposium, “Approaches to Safe Nanotechnology: A Global Perspective,” was held at the XVIII World Congress on Safety and Health at Work in Seoul, Korea. That brought together speakers/scientists from seven countries to discuss the topic, including those from the United States, Japan, Korea, Australia, Germany, France, and Italy. The lessons learned and the importance of global collaboration on nanotechnology safety and health research were discussed. A report of the symposium proceedings was recently published by the United States participant, the National Institute for Occupational Safety and Health (NIOSH), “A Global Perspective on Safe Nanotechnology,” NIOSH Publication No. 2009-130.

The occupational health risks associated with engineered nanoparticles (i.e. produced intentionally with specific properties) are not yet clearly understood. The studies published to date challenge conventional workplace exposure and risk assessment approaches. Therefore, addressing the risks of engineered nanostructured particles will be among the major ongoing global occupational safety and health concerns in coming years.

In late 2009 there is still a huge gap between technological progress and research into the health and safety aspects of nanomaterials. Since the turn of this century, nanotechnology has grown exponentially, as confirmed by the number of products on the global market and the rapidly increasing funds dedicated to global research and development in this sector. Achieving the goal of keeping workers safe from potential harm of this new technology will require the international scientific and regulatory community to collaborate on research concerning the risks of exposure to nanomaterials in the workplace. Through continued coordination amongst governments, industry, and other stakeholders, the occupational safety and health community hopes to remain a leader in the responsible development of nanotechnology.

Workplace Nanotechnology Safety in the United States

The National Institute for Occupational Safety and Health (NIOSH) is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. This research focuses NIOSH’s scientific expertise, and its efforts, on answering the questions that are essential to understanding these implications and applications:

How might workers be exposed to nano-sized particles in the manufacturing or industrial use of nanomaterials?
How do nanoparticles interact with the body’s systems?
What effects might nanoparticles have on the body's systems?

NIOSH’s Nanotechnology Research Center has published two excellent reports: Progress Toward Safe Nanotechnology in the Workplace (June 2007), and Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (March 2009). The 2009 Report describes the current NIOSH strategy for addressing priority research on the occupational safety and health aspects of nanomaterials to understand the potential risks that nanotechnology may have to workers. I discussed this in more detail in my 9/22/09 post, "Nanotechnology Risk in the Workplace."

Nanotechnology Safety in Japan

Japan is among the top 3 global nanotechnology players and the Japanese government has recognized the need for safe nanotechnology. In 2007, the Council for Science and Technology Policy issued a set of policies, entitled “Promotion of Novel Interdisciplinary Fields Based on Nanotechnology and Materials, Research & Development”. The government has also guided efforts by administrative organs to conduct research for safe nanotechnology in the workplace. In February 2008, the Ministry of Health, Labour, and Welfare introduced a guideline for Japanese workers producing or handling nanomaterials. As a result of these efforts, it is expected that the progression of nanotechnology health and safety research in Japan will be accelerating in 2009 and into 2010.

Nanotechnology Safety in Korea

Korea is one of the world’s top 5 developers of nanotechnology. The Korean government is well aware of nano safety and the Korean Occupational Safety and Health Agency (KOSHA) held its first international symposium on nano safety titled “The Health Risks Associated with Nanotechnology” in 2005. That triggered concerns especially with the protection of workers from exposure to the unknown hazards of nanoparticles. KOSHA has been active in such research, having completed studies on cytotoxicity in vitro with numerous types of commercial nanoparticles such as Ag, Cu, Fe, Ni, magnetic nanoparticles, single-walled carbon nanotubes (SWCNTs), and multi-walled carbon nanotubes (MWCNTs), and a great deal of additional research is under way. A draft of guidelines for safe handling of nanomaterials in the workplace was submitted to the KOSHA in 2008.

Meanwhile, outside the occupational field, the Ministry of Environment (MOE) implemented a nano safety project, Ecotechnomia21, to support the establishment of an infrastructure necessary to minimize potential environmental risks from the manufacture, distribution, and disposal of nanomaterials and nanomaterial-containing products. And the Korean Food and Drug Administration’s (KFDA) has in place research projects on the toxicity of nanomaterials in food, drug, and cosmetics uses.

Nanotechnology Safety in Australian Workplaces

In May 2007, the Australian Government announced support for implementation of the National Nanotechnology Strategy. Under the Strategy there is a particular focus on the environment, public and occupational health, and safety issues. The Australian Government has funded the Office of the Australian Safety and Compensation Council (ASCC) to establish a nanotechnology occupational health and safety research and development program (OHS Program) to address potential OHS issues related to nanomaterials.

New Evidence for Toxic Effects of Inhaled Nanotubes

Tue, 27 Oct 2009 12:51:14 GMT

A new study published October 25, 2009, in Nature Nanotechnology online -- "Inhaled Carbon Nanotubes Reach the Subpleural Tissue in Mice" -- provides further evidence for the asbestos-like effects of certain types of carbon nanotubes.

The study, by researchers at North Carolina State University, The Hamner Institutes for Health Sciences, and the National Institute of Environmental Health Sciences (all in the United States), found for the first time that multi-walled carbon nanotubes (MWCNTs) reach the outer lining of the lung when inhaled - as asbestos does. The findings raise concerns that inhaled nanotubes may cause pleural fibrosis and/or mesothelioma.

Carbon nanotubes, like asbestos, have high aspect ratios; in other words, they are long and thin, meaning they have the potential to get stuck when trying to cross the two layered membrane - the pleura - separating the lung from the chest wall. In the case of asbestos, fibers can dwell in this area, causing lung disease and mesothelioma, a type of slow-growing cancer.

But the authors of the study say the results should be interpreted with caution. “We're not saying that carbon nanotubes are going to be like asbestos. We don't know yet,” says James Bonner, a lead researcher. “There's no evidence of cancer. The major finding is that we're saying that nanotubes get to the site where mesothelioma would occur, but we don't have the information to say that it does occur.”

The study authors also agree that the study does not have generic significance for other types of nanotubes, which come in many different lengths, compositions and contaminants. Further studies comparing the effects of nanotubes from different sources, of different sizes and at lower doses are required to draw any broader conclusions.

The Study Design & Findings

In the study, mice were exposed to MWCNTs at two different doses and lung tissue was collected and examined at set periods over the following 14 weeks. Effects were seen within one day for the mice inhaling the larger dose of MWCNTs, with no effects seen in the mice that inhaled the lower doses of nanotubes. According to the article, "[T]he development of subpleural fibrosis in mice suggests that MWCNTs could behave like asbestos in that they (1) are deposited at the alveolar level, (2) reach the subpleura after inhalation, and (3) remain in the subpleura intact for weeks to stimulate fibrosis.” The study also showed that the immune response and fibrosis disappeared 14 weeks after exposure, although this study was based on a single exposure and did not address the health effects of long-term, chronic exposure. The authors suggest that minimizing inhalation of nanotubes during handling is ". . . prudent until further long-term assessments are conducted."

The timescale (14 weeks) of the experiment was not long enough to test whether inhaled nanotubes cause mesothelioma, but the research team did see damage in the form of fibrosis - scarring of the pleura - which is also seen with asbestos. Mice that inhaled multi-walled carbon nanotubes developed fibrosis after around two weeks, with the nanotubes accumulating in immune cells in the region just below the pleura. By comparison, mice inhaling carbon black nanoparticles, which do not have the crucial high aspect ratio, did not develop fibrosis.

The Significance of “Inhaled Carbon Nanotubes Reach the Subpleural Tissue in Mice”

The new research contributes to the emerging evidence base on the inhalation toxicology of high aspect ratio nanoparticles. Last year, concerns were raised for the safety of those working with nanotubes when a paper published in Nature Nanotechnology concluded that nanotubes could damage lung tissue if injected into the abdomen of mice. That study, commonly known as the “Poland Study” (C. Poland, et al., Carbon Nanotubes Introduced Into The Abdominal Cavity of Mice Show Asbestos-Like Pathogenicity In a Pilot Study, Nature Nanotechnology, May 20, 2008), sparked a rash of popular media coverage and fears that exposure to carbon nanotubes may, like asbestos, cause mesothelioma. Critics of the Poland Study suggested that popular media coverage was hyperbolic and that the study itself was flawed in a number of respects, including for the reason that the MWCNTs in that study were not inhaled into the lung, but were injected into the abdominal cavity of the mice studied. See, for example, Monica & Monica, A Nano-Mesothelioma False Alarm, Nanotechnology Law & Bus., Fall 2008, and A. Kane, et al., The Asbestos Analogy Revisited, Nature Nanotechnology, July 2008.

The recent study by Bonner and colleagues, while it has acknowledged limitations, goes beyond the methodology of the Poland Study and now provides an insight into potential effects of exposure in the “real world” by examining what happens when high aspect ratio MWCNTs are inhaled.

The study also illustrates a fundamental principle of toxicology in the nanotoxicoloy context: the risk posed by any substance is related to dose and exposure, that is, without a sufficient dose/exposure, the risk is minimized or eliminated.

Nano and the Top 10 Pharmaceutical Companies – A Cautious Involvement?

Mon, 26 Oct 2009 13:26:51 GMT

The top 10 Pharma companies (alphabetically Abbott, AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis) all have significant nanotechnology-related programs. Three 3 facts of interest:

     - Most of these companies only applied for a small number of nanotech-related patents so far ; but overall, the yearly volume of new “nano & pharma” patents has increased almost every year since 2000.

     - Big pharmas seemingly do not have a lot of in-house expertise in nanotech (or do not communicate about such expertise) and those who involve themselves in the nano field have been doing so primarily by partnering with small, specialized companies (maybe also to limit the risks).

     - Several big pharmas released rather cautious general statements summarizing their stand about nanotech ; for example GSK, who “is actively investigating a number of opportunities that utilize nanomaterials” in its R&D programs, insists on risk assessment and risk management in its April 2009 statement.

Medical and pharma applications of nanotech are one of the key editorial lines of the Nanocolors blog. Here is a recap of the 10 medical/pharma-related trend charts already released on the blog in 2009, ranked by number of visits.

1. Nano patents & the top 10 big pharmaceutical companies
2. Nanoparticles in clinical trial phases
3. Nanoparticles in clinical trials since 2000
4. Nano & drug delivery patents since 2000
5. Nano & pharma patents since 2000
6. Nanoparticles & cancer therapy in biomedical publications since 2000
7. Nanoparticles in clinical trials – status regarding participant recruitment
8. Nano & vaccines in patents since 2000
9. Nanomedicine in biomedical publications since 2000
10. Nanosurgery in biomedical publications since 2000

These 10 charts and related commentary are available at:
http://nanocolors.wordpress.com/2009/10/24/focus-on-medicalpharma-related-nano-trends/

Is Nanotechnology Dangerous? Germany's View

Fri, 23 Oct 2009 15:25:04 GMT

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.

The maelstrom began when UBA posted the 28-page paper about nanotechnology on their Web site. But UBA officials feel they have been misunderstood, and that the paper is neither a warning nor a new study -- it's just a background paper. "We haven't done any of our own research," UBA scientist/spokesperson Wolfgang Dubbert told SPIEGEL ONLINE. Dubbert is one of the authors of the paper, an updated version of a document published in 2006.

UBA’s Cautious Criticism of Nanotechnology

Germany is one of the European leaders in commercialization of nanotechnologies. "We do not know how many products there are on the market that contain nano-particles," Dubbert told German press agency DPA on Wednesday. And consumers can't really avoid them either. Apart from sunscreen, "the products on the shelves are not labeled" as containing nano-particles.

"Through the increasing use of synthetic nanomaterials, one must assume their increased entry into the environmental media, including the soil, water and air," the experts write in the UBA paper. "Up to now there has been a partial lack of testing methods appropriate for determining the risks of nanomaterials and for ensuring monitoring."

In the press release accompanying the paper the UBA said, "although nanotechnology offers significant potential for ecological product innovation, there is also risk for the environment and to human health. There are still some serious gaps in knowledge. This suggests that there are plenty of possibilities for research and regulation."

There are several programs in Germany seeking to determine the safety of nanotechnologies, including the Nanocare program funded by the Federal Education and Research Ministry, which produced data for 11 different nanomaterials over the summer. A second phase of the project just began. There are also programs like Nanonature, which is studying the ecotoxicological effects of nanotechnology.

UBA’s Call for Mandatory Nanotech Labeling

But it could be years before these major research projects provide answers. For that reason, UBA's paper calls for a mandatory registration of products that contain nanotechnologies in order to "increase transparence." New EU directives require the registration of chemicals in products (REACH), and the same ought to be applied to nanoproducts, the UBA suggests. And "[s]o that people have the freedom of choice we need to strive for a suitable labeling system that informs without suggesting a danger."

Dangers But Too Early to Reach Conclusions

Some studies have emerged that do appear to show some specific types of nanomaterials may be harmful. Generally, however, the feeling of most researchers has more to do with concern about lack of information on the subject, rather than well-established danger. A balanced approach is required. Says UBA's Dubbert, "you can't just talk about the risks -- you also have to look at the opportunities."

For a good, balanced discussion of the recent events, read Christoph Seidler’s SPEIGEL ONLINE INTERNATIONAL article, published 10/23/09, at the link below.
http://www.spiegel.de/international/germany/0,1518,656482,00.html

Demands for Ultra-Regulation of Nano-Silver – The First Battle for the Nanotechnology Industry’s Future?

Tue, 20 Oct 2009 14:20:23 GMT

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.

The EPA published notice of the ICTA Petition in the Federal Register for public comment (see 73 Fed. Reg. 69644 and 74 Fed. Reg. 2072) and received over 1,000 comments before the comment period closed. EPA is currently reviewing the comments and formulating its response to the ICTA Petition.

Why is the Attack on Nano-Silver Significant?
Rubinstein accurately assesses the ICTA Petition as having fired a significant “initial shot over the bow” of the nanotechnology industry. Silver nanoparticles are already used in more consumer products than any other nano-material, primarily because nano-silver is a highly effective bactericide and anti-microbial. For example, nano-silver is already in use in home appliances, infant cups and utensils, food packaging, water filters, socks, bedding materials, undergarments, and other products.

Rubinstein points out that the ICTA attack on nano-silver seems scientifically misplaced inasmuch as the data uniformly suggest that it is non-toxic and non-carcinogenic in humans. However, it must be conceded that there have been some recent studies finding potential environmental toxicity/significance as well as toxicity to some fish and acquatic non-vertebrates. In theory, expanding use of nano-silver in consumer products could cause silver wastewater discharges to increase, leading to the potential for problematic impacts as yet unknown.

Who is the ICTA and Why Should You Care?
The ICTA IRS Form 990 tax return and its website states that the organization’s purposes include, “Halt the commercialization of nanotechnology until products containing nanoparticles have been proven safe." The funding of ICTA is unclear but it seems apparent, from a fair reading of its publicly-available materials concerning nanotechnology and the contents of its Petition to the EPA, that ICTA is not so much interested in science as it is in waging a raw propaganda war, using politically charged language and making claims that are empirically unsupportable. The intended effect is to negatively impact the perception of nanotechnologies held by politicians, regulators, and the public, and not to earnestly discuss the science of nanoparticles.

What is at Stake?
Rubinstein, rightly in my view, concludes that “[t]he ICTA Petition is but the first step in what will likely be a long and bitter war,” and he urges the nanotechnology industry to learn from the mistakes of other industries, to take effective steps to preserve consumer faith and confidence, and not to shrink from engaging in the coming war worth fighting.

That war will include battles in a number of theatres. As I have suggested in a number of articles – including The Dawn of the Age of Nanotorts, available by clicking on “Articles and Presentations” on the Home Page for this site – one significant theatre of the war will be the courtrooms of America through the tort litigation process.

Occupational Exposures to Nanomaterials: Current Safety Equipment May Not Be Adequate to Protect Workers from Adverse Health Effects

Thu, 15 Oct 2009 18:06:12 GMT

Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposures to engineered nanoparticles is quite small, and uncertainty means risk.

A new Canadian study to appear in a forthcoming issue of the International Journal of Nanotechnology suggests that current protective equipment used for existing chemicals may not offer adequate protection for workers handling nanomaterials. The study, by engineers in the Department of Mechanical Engineering at Montreal’s School of Higher Technology, suggests that urgent research is necessary into the risks associated with the growing field of nanotechnology manufacture so that appropriate protective equipment can be developed. Prevention of harmful exposures from ingestion, inhalation, and dermal absorption are the reason that protective clothing and gloves, in addition to respirators, are often an essential and common sight in the chemical industry. However, the Canadian researchers wonder if standard protection against chemical risks is enough for workers who are handling nanomaterials.

Why is This a Big Deal?
According to the most recent estimates from the U.S. National Science Foundation, the nanotechnology market could reach as much as $1 trillion by 2011. This corresponds to about 2 million workers involved in nano-related activities. As this area of manufacturing grows it would be prudent to develop adequate workplace protection sooner, rather than later. Indeed, those workers most likely to be exposed to nanomaterials will be working in cleaning, bagging and formulation activities as well as surface functionalization of nanoparticles.

The anticipated workplace hazards associated with the diverse range of substances falling under the general and broad tag of "nanomaterials" remains largely unknown. Although it has already been shown that nanoparticles may affect biological activity through oxidative stress at the cellular and molecular levels, those effects are yet to be manifest as health problems among workers.

What About Existing Workplace Safety Standards and Equipment?
Existing regulations and standards testing for protective clothing and equipment are almost devoid of references to nanomaterials specifically. Moreover, although some researchers have concluded that certified respirators offer an appropriate level of protection against nanoparticles, there remain large uncertainties, for example due to the increased potential of leaks at face seals because of the very small size of nanoparticles, a few billionths of a meter in diameter.

Recent Reports of Interest to Advancing Nano-Workplace Safety

1. Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (March 2009)
This document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops.

2. Current Intelligence Bulletin 60: Interim Guidance for the Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles (February 2009)
NIOSH offers guidance in response to ongoing interest by employers and other stakeholders in having authoritative occupational safety and health guidance in the manufacturing and industrial use of engineered nanomaterials.

3. The international Organization for Economic Cooperation and Development (OECD) also released three new reports in a series of papers and studies on the safety of engineered nanomaterials. The new reports include significant NIOSH leadership in the OECD committees and working groups that developed and sponsored the reports. The reports are:

"Report of an OECD Workshop on Exposure Assessment and Exposure Mitigation: Manufactured Nanomaterials"

"Comparison of Guidance on Selection of Skin Protective Equipment and Respirators for Use in the Workplace: Manufactured Nanomaterials"

"Emission Assessment for Identification of Sources and Release of Airborne Manufactured Nanomaterials in the Workplace: Compilation of Existing Guidance"

About the OECD
The Organization for Economic Co-operation and Development (OECD) is an intergovernmental organization in which representatives of 30 industrialized countries in North America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonize policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD's work is carried out by more than 200 specialized committees and working groups composed of member country delegates.

The Environment, Health and Safety Division of the OECD publishes free-of-charge documents in ten different series, including a Series on Safety of Manufactured Nanomaterials. More information about the Environment, Health and Safety Program and EHS publications is available on the OECD's World Wide Website (http://www.oecd.org/ehs).

Nanotechnologies Roundtable with Dr. Andrew Maynard

Wed, 14 Oct 2009 08:44:36 GMT

On October 5, 2009, the Wisconsin Department of Natural Resources hosted a roundtable discussion with Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, D.C.

Discussion topics include nanotechnology basics and definitions, manufacturing process and opportunities, regulatory status, and potential environmental and health concerns.

Video of the interesting 90 minute discussion is available here.

Dr. Andrew Maynard is perhaps the most well-known and sought after speaker on the subject of developing nanotechnologies safely. Dr. Maynard has testified before the U.S. Congress on nanotechnology policy on numerous occasions and has previously served on the Nanotechnology Technical Advisory Group of the U.S. President’s Council of Advisors on Science and Technology (PCAST). He has been a member of panels convened by the National Academies of Science and The Council of Canadian Academies, and is an executive committee member of the International Council on Nanotechnology (ICON). Andrew was previously a member of the federal government Nanoscale Science, Engineering and Technology (NSET) subcommittee of the US National Science and Technology Council, and was co-chair of the Nanotechnology Health and Environment Implications (NEHI) working group of NSET.

Dr. Maynard writes regularly for a broad audience on science and society at 2020science.org. I recommend checking his site regularly for useful nanotechnology risk and safety information and commentary.

Nanotech and the Environment – Miracle or Menace?

Mon, 12 Oct 2009 11:30:47 GMT

In a 10/12/09 post with the above-title, GreenFudge.org poses the important question, which has no clear answer: "So what’s so scary about nanotechnology?"

With technological progress comes the increased potential for misuse and harm. The post suggests that fears about nanotechnology include those imagined (for example, tiny machines let loose into the environment; self-replicating nanobots that could conceivably become corrupt or out of control and act in a similar way that cancer cells – biological cells gone awry – do in organic bodies) and perhaps more realistic (imagine powerful nanotech in the wrong hands; dangerous nanoparticles being released into food and water sources by terrorists). And the fact that we simply still don’t know what nanotech is capable of, just as we used to be unaware that certain chemicals are poisonous or harmful to the environment or that CFCs were cutting a hole in the ozone layer.

Of course it is the latter type of fear that is of greatest practical significance to those companies involved with the manufacture and disrtibution of nanotechnology-enabled products, along with those in the risk management chain and their counsel.

The post also links to several other European-perspective nanotechnology risk items of interest, including:

- European Commission – Nanotech: Panacea or Pandora’s Box?

- BBC Blog: The Impact of Nanotechnology

Note: Greenfudge.org is a non-profit, privately funded organization. Its stated objective is "to present the latest and most accurate information on global environmental issues" and "to stimulate discussions regarding issues that affect everyone."

“Environmentally Responsible Development of Nanotechnology” Event Hosted by The Research Triangle Environmental Health Collaborative

Thu, 08 Oct 2009 16:45:22 GMT

The Research Triangle Environmental Health Collaborative (The Collaborative) will gather 150 experts from around the nation at its second annual environmental health summit on October 8-9, 2009. The 2009 summit, “Environmentally Responsible Development of Nanotechnology,” is being held at the North Carolina Biotechnology Center in North Carolina’s Research Triangle Park.

This year’s summit features a broad and experienced group of participants representing wide areas of expertise and diverse views from Federal, State, and local governments; academia, industry, and public interest organizations. Speakers include Mark Wiesner, of Duke University’s Center for the Environmental Implications of NanoTechnology (CEINT), and Chad Holliday, Chairman of the Board and former CEO of DuPont, Inc.

Says Collaborative chairman Ken Olden, former director of the National Institute of Environmental Health Sciences: “There are still many unknowns about the environmental impact of nanotechnology locally, as well as around the world, and we have many experts in our region focused on various solutions.”

This is the second summit presented by The Collaborative, and will identify critical issues in nanotechnology-enabled product development and manufacturing with the aim of allowing nano-business to overcome barriers to success related to environmental and occupational health concerns.

Guidance Document to be Produced

The outcome of this meeting is expected to include a guidance document to highlight these critical issues and provide business and policymakers with recommendations about how to successfully address them. Stay tuned for a future post on that subject.

Research Triangle Park and Nanotechnology

Research Triangle Park, N.C. was recently ranked as the No. 4 “Nano Metro” in the United States by the Project on Emerging Nanotechnologies (trailing only Boston, San Francisco and San Jose).

The Research Triangle Environmental Health Collaborative

The Collaborative is a non-profit organization supporting a united environmental health resource that connects organizations and institutions; links research and policy; and joins government, academia, industry, and public interest groups to mutually consider, discuss and debate the future of environmental health on a regional, national and international level. It provides a neutral forum to host candid discussions and to provide advice on the most significant issues facing environmental health and related public policy. www.EnvironmentalHealthCollaborative.org

Nanomedicine and the FDA – Part 2

Wed, 07 Oct 2009 08:50:03 GMT

Part 1 discussed the mission of the U.S. Food and Drug Administration, in part, in connection with drugs, drug delivery systems, medical devices, vaccines, and other biologic products, and how the FDA has thus far addressed the assimilation of nanotechnology into those products.

The FDA has thus far been relatively unconcerned about any unique safety issues of nanoscale products under its auspices, and believes that existing standards for safety and efficacy will be adequate for most nanotechnology medical products. See, e.g., FDA and Nanotechnology Products, FAQs.

The FDA Nanotechnology Task Force Report

The FDA’s Nanotechnology Task Force published its Report in July 2007 and in 2008 held a Public Meeting intended "to gather information that will assist the Agency in implementing the recommendations of the Nanotechnology Task Force Report." The Task Force Report did not suggest the need for any immediate nano-specific regulatory action, but did recognize that obvious knowledge gaps exist concerning new risks presented by nanomaterials. In light of the limits of current science, however, the Task Force specifically declined to recommend adoption of any new labeling rules requiring identification of the presence of nanoscale materials.

The Report’s authors also noted that the nature of nanoscale materials permits the development of highly integrated combinations of drugs, biological products, and/or devices, having multiple types of uses, such as combined diagnostic and therapeutic intended uses. As a consequence, the FDA recognized that many anticipated nanomedical products will be difficult to categorize as drugs, devices, or biologics, and many will be considered combination products. Because combination products involve components that are normally regulated under different types of regulatory authorities, and frequently by different FDA centers, they raise challenging regulatory and review issues. See, e.g., Sadrieh and Espandiari, Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?, 3 Nanotechnology L. & Bus. 339, Sept. 2006. It seems that the current paradigm for selecting regulatory pathways for such combination products may need to be assessed to ensure predictable determinations of the most appropriate pathway for highly integrated nanomedical combination products. Let's see if that happens in the near future.

Critics of FDA’s Current Position on Nanotechnology

Critics of the FDA's position have urged the FDA both formally and informally to move more quickly to specifically address nanomaterial risks. For example, in May 2006, the International Center for Technology Assessment (ICTA) and a coalition of consumer, health, and environmental groups filed a formal legal petition with the FDA, calling on the agency to address the risks of nanomaterials through enactment of comprehensive nano-product regulations, including treating nanomaterials as new substances, using nanomaterial-specific toxicity testing paradigms, and requiring nano-product labeling. (Petition available at www.icta.org/doc/nano%20FDA%20petition%20final.pdf.) The ICTA petition, which is still pending, "raises complex issues requiring extensive review and analysis by agency officials, and in relation to which the agency is seeking public input." FDA, Nanotechnology Task Force Report.

Experts have also offered recommendations for more science-based FDA regulations to address the wide range of nanomedical products (nanopharmaceuticals, nanomedical devices, nanobiologics); such as by the creation of a multidisciplinary expert panel to identify unique safety issues associated with nanoscale products; development of a new paradigm for evaluating data pertaining to safety and efficacy of nanoscale products by a team of experienced regulators from the drug (CDER), biologic (CBER), and device (CDRH) areas of the FDA; and developing unique tools and techniques to better characterize nanoscale materials used in medical applications. See, e.g., Bawa, et al., Nanopharmaceuticals: Patenting Issues and FDA Regulatory Challenges, 5 The SciTech Lawyer No. 2, Fall 2008.

While the FDA seems intent on handling the new generation of nanotechnology-based medical products with the traditional product-by-product regulatory model, some experts also question the wisdom of that approach. For example, it is feared that attempts to classify nanobiotechnological products into the traditional categories of medical products — drug, device, biological or combination product — is clumsy and will result in inconsistent regulatory treatment. One reason is that nanotechnology applications can produce indistinct effects no longer easily classified as mechanical, chemical or biological, thereby creating problems in categorizing the nanomedical products into one of the available traditional classifications. The legal classification of nanomedical products is of basic importance because the widely divergent FDA market-approval processes and the applicable standards of safety and effectiveness depend on how they are regulated. See Miller, Beyond Biotechnology: FDA Regulation of Nanomedicine, 4 Colum. Sci. & Tech. L. Rev. 5 (2002); Foote and Berlin, Can Regulation Be As Innovative As Science and Technology? The FDA’s Regulation of Combination Products, 6 Minn. J.L., Sci. & Tech. 619 (2005).

Where From Here?

It remains to be seen what additional internal processes or regulatory actions, if any, the FDA will pursue to address nanospecific product and safety issues. This is an evolving area of regulatory law and all pharmaceutical, medical device, and health care risk managers and their attorneys must stay closely attuned. In the meantime, with the many unknowns that nanotechnology and its application to medical purposes present, it appears highly likely that many of the questions posed by this new technology will be answered first in the courtroom. That’s why medical care providers and their legal representatives need to start looking at the issues raised by nanomedicine; by doing so, they will put themselves in a better position to assess the values and reduce the risks of employing these new technologies for improving patient health outcomes.

Nanomedicine and the FDA - Part 1

Thu, 01 Oct 2009 14:57:28 GMT

FDA Mission

The mission of the U.S. Food and Drug Administration is, in part, to ensure that the drugs, drug delivery systems, medical devices, vaccines, and other biologic products reaching the marketplace are safe and effective. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicine more effective and more affordable. The oncoming "Age of Nanotechnology" brings into sharp focus the tension between assuring that regulated products are safe and effective while at the same time ensuring that new and potentially life-saving treatments are made available to the public as quickly as possible.

FDA Regulates Products, Not Technology

The role of the FDA as gatekeeper for the application of nanotechnologies to medicine is governed by a basic principle: The FDA regulates products, not technology. The FDA, for example, does not regulate materials or manufacturing processes, per se, but instead regulates the end products. This principle affects the stage at which the FDA becomes engaged in the regulation of nanotechnology and when, in the process, any regulation takes effect. Under the FDA’s category-based system, a drug, biologic, or device would be assigned for evaluation respectively to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH). Recognizing that certain therapeutics are "combination products," which consist of two or more regulated components (drug, biologic, or device) that are physically, chemically, or otherwise combined or mixed to produce a single entity, the FDA established the Office of Combination Products (OCP) in 2002 to address these challenges.

FDA Regulates Claims Made By Product Sponsor

Also important, the FDA regulates only to the "claims" made by the product sponsor. If the manufacturer makes no nanotechnology claims regarding the manufacture or performance of the product, the FDA may be unaware at the time the product is being review and approved that nanotechnology is being employed.

Existing Nanomaterial Products Approved by FDA

A handful of existing products regulated by the FDA contain nanomaterials — including several drugs processed through the CDER and several medical devices processed through CDRH — and each was approved by the FDA using existing pathways and without any special testing. (There is not yet any systematic way to identify nanotechnology products using the FDA’s Web site, but several commentators have gleaned the information from a number of reliable sources. See Cindy Strickland, Nano-Based Drugs and Medical Devices: FDA’s Track Record, 4 Nanotechnology L. & Bus. 179, June 2007 (identifying seven specific drugs and three medical devices that have been approved); Bawa, Melethil, Simmons and Harris, Nanopharmaceuticals: Patenting Issues and FDA Regulatory Challenges, 5 The SciTech Lawyer No. 2, Fall 2008; Bawa, Nanoparticle-based Therapeutics in Humans: A Survey, 5 Nanotechnology L. & Bus. 135, Summer 2008 (identifying seven nanopharmaceuticals currently on the market).

FDA Nanotechnology Task Force and NanoTechnology Interest Group (NTIG)

The FDA has recognized that existing regulatory processes and pathways should be assessed and, where necessary, modified to accommodate nanotechnology. In response to the rapid emergence of nanoscience-based medical applications and concerns about possible health and safety risks, the FDA formed an internal FDA Nanotechnology Task Force and a NanoTechnology Interest Group (NTIG) in 2006. (The NTIG has participation from all FDA Centers (e.g., CDER, CBER, CDRH) and all FDA Offices that report directly to the Office of the Commissioner (e.g., OCP). Each Center has established a multidisciplinary nanotechnology-focused working group. These working groups are charged with identifying and defining the regulatory challenges in each discipline and proposing solutions to overcome these challenges. See FDA and Nanotechnology Products, FAQs,

Part 2 will discuss the FDA Nanotechnology Task Force Report and the current thinking about FDA regulation of products incorporating nanomaterials.

Nanotechnology Standards: ASTM International

Wed, 30 Sep 2009 09:30:55 GMT

Prudent manufacturers, sellers, and employers in the Nanotechnology community must maintain knowledge of all relevant standards, whether governmental or voluntary. Although standards developed by organizations like ASTM International are not government-issued mandatory standards with the force of law, they can be extremely important. In some cases, governments will adopt such voluntary standards, thus giving them legal effect. Even if not, evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

ASTM International, originally known as the American Society for Testing and Materials (ASTM), is one of the largest voluntary standards development organizations in the world. Standards developed at ASTM are the work of over 30,000 ASTM members. These technical experts represent producers, users, consumers, government and academia from over 120 countries.

In order to make the consensus standards being developed by ASTM more visible to the Nanotechnology community, ASTM now has a new Nanotechnology-focused page on its website. ASTM standards for nanotechnology provide guidance for nanotechnology and nanomaterials, as well as nanotechnology terminology, property testing, and issues of health and safety.

ASTM has thus far issued one standard concerning Nanotechnology health and safety, the Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings, published October 2007. That Guide “describes actions that could be taken by the user to minimize human exposures to unbound engineered nanoscale particles (UNP) in research, manufacturing, laboratory and other occupational settings where UNP may reasonably be expected to be present.” Of special importance with respect to its intended scope of application: “It is intended to provide guidance for controlling such exposures as a cautionary measure where neither relevant exposure standards nor definitive hazard and exposure information exist.”

Because there are not yet any accepted “relevant exposure standards” nor any “definitive hazard and exposure information” concerning occupational exposure to any nanomaterials, by its own terms the Standard Guide would currently apply to virtually every occupational context where unbound engineered nanoscale particles are present.

Do you and your organization, or your clients, understand and apply the Guide?

If not, are you willing to accept the potential risk of noncompliance with an ASTM standard?

Other Nanotechnology standards developed by ASTM are listed below. All are available for purchase and download from the ASTM:

Informatics and Terminology
- Standard Terminology Relating to Nanotechnology, E2456 - 06

Characterization: Physical, Chemical, and Toxicological Properties
- Standard Guide for Measurement of Particle Size Distribution of Nanoparticles in Suspension by Photon Correlation Spectroscopy (PCS), E2490 - 09

- Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles, E2524 - 08

- Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies, E2525 - 08

- Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells, E2526 - 08

- Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions, E2578 - 07

Nanotechnology Exposure Assessment: Call For Papers

Tue, 29 Sep 2009 06:53:09 GMT

The critical importance of exposure assessment as an integral component of risk assessment and risk management of nanomaterials is widely recognized. Significant effort is now focused on development of methods for characterizing, measuring, and modeling occupational and environmental exposure levels throughout nanomaterial product life cycles.

The International Journal of Occupational and Environmental Health (IJOEH) is seeking submissions for a special issue provisionally titled, “Human and Environmental Exposure Assessment for Nanomaterials,” to be guest edited by Vladimir Murashov, PhD, Special Assistant to the Director, National Institute for Occupational Safety and Health.

The special Nanomaterials issue of the IJOEH originates from presentations and discussions at the U.S. National Nanotechnology Initiative workshop on Human and Environmental Exposure Assessment (http://www.nano.gov/html/meetings/exposure/index.html) held on February 24-25, 2009 in Bethesda, MD. According to the IJOEH, "The special is issue seeks to make a substantial contribution to the responsible introduction of nanomaterials into commerce by presenting critical data for risk management through state-of-the-science assessments, by identifying critical research gaps, and by facilitating coordinated efforts to address the gaps."

Submit manuscripts at www.ijoeh.com. For information on the special issue, contact Vladimir Murashov at vladimir.murashov@cdc.hhs.gov.

Submissions must be received by January 15, 2010

Nanotechnology Risks: Insurance Implications

Mon, 28 Sep 2009 09:07:59 GMT

The core business of the insurance industry is the transfer of risk. Thus the insurance business identifies, evaluates and diversifies risk in order to minimize the total capital cost of carrying it. However, the traditional means of diversification reach their limits when:
– it is no longer possible to assess the probability and severity of risks
– many companies, industry sectors and geographical regions are affected simultaneously
– the magnitude of a possible event exceeds the capacities of the private insurance industry

Nanotechnology, as an emerging risk, challenges the insurance industry because of the high level of uncertainty in terms of potential nanotoxicity or nanopollution, the ubiquitous presence of nano-products in the near future (across industry sectors, companies and countries) and the possibility of long latent, unforeseen claims.

Nanotechnology risks implicate many lines of business:
– General liability
– Products liability
– Products recall
– Environmental liability
– Hazardous material transportation
– Property damage
– Workers’ compensation

It is too early to quantify potential losses related to nanotech risks; because risk is incalculable, insurers must develop loss scenarios and loss-limiting measures. There are no specific policy exclusions or terms in regular use tailored to address nanotech risks. There is a likely “stacking of limits” problem due to long-term loss accumulation caused by long latency periods for human and environmental impacts.

What about a general policy exclusion for nanotechnologies? Although it was tried briefly and abandoned in late 2008 by Continental Western Group (see its initial attempt at http://cwgins.com/mike/documents/CW33690608NanotubesExclusion.pdf and http://cwgins.com/mike/documents/PN61610708.pdf) that is not really feasible for a number of reasons:

- nanotechnologies cover a very broad field with far from uniform risk characteristics
- no uniform language or set of definitions exist
- variety of nanotechnologies and applications across broad industry segments means positive insurance portfolio diversification possible
- exposure of general population to nanotechnologies is still comparatively low

Solving the “Stacking of Limits” problem?
Today most nanotechnology risks are written on occurrence policies. Various triggers of coverage – exposure, manifestation, injury-in-fact, continuous – lead to multiple liability policies in different policy periods potentially responsible for providing coverage for a single claim or group of claims against policyholder. The "stacking of limits" problem encountered with other exposure and environmental claims can be reduced by:

– “Claims made” coverage for nanotechnology risks
– More precise descriptions under which a loss is said to have “occurred”
– Prior Insurance and Non-Cumulation of Liability Condition

High priorities for insurers in 2009:
• Bringing the discussion of nanotechnology to the forefront of insurance

• Focusing attention of underwriters and risk managers on critical nanotechnology risk issues

• Awareness of independent research into the risk of nanoparticles, exposure routes and their effect on humans and the environment

• Strengthening of the evidence base regarding the safe handling of nanoparticles and implementation of risk management best practices

• Development of comparative risk classification schemes and databases

Nanotechnology Risks: Initial U.S. Government Regulatory Response?

Fri, 25 Sep 2009 07:34:54 GMT

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.

Nanotechnology Risk in the Workplace

Tue, 22 Sep 2009 05:00:00 GMT

As with any new technology, the earliest and most extensive exposures to engineered nanoparticles are likely to occur in the workplace. Workers may be exposed to nanomaterials during the manufacturing, end use, or during the disposal or recycling of nanomaterial-containing products and workplace exposure levels and frequencies are likely to be higher than that seen in the general environment.

The National Institute for Occupational Safety and Health (NIOSH) is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. This research focuses NIOSH’s scientific expertise, and its efforts, on answering the questions that are essential to understanding these implications and applications:

How might workers be exposed to nano-sized particles in the manufacturing or industrial use of nanomaterials?
How do nanoparticles interact with the body’s systems?
What effects might nanoparticles have on the body's systems?

NIOSH’s Nanotechnology Research Center has published two excellent reports: Progress Toward Safe Nanotechnology in the Workplace (June 2007), at http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf, and Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (March 2009), at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf. The latest information is available at the NIOSH Nanotechnology topic web page at http://www.cdc.gov/niosh/topics/nanotech.

Workplace exposure risks associated with the manufacturing of nanomaterials come within the auspices of the Occupational Safety and Health Act, 29 U.S.C. §651 et seq., and the regulations promulgated under the Act. That includes the need to assess and, where necessary, address and mitigate the risks. See 29 U.S.C. §654 and 29 C.F.R. Part 1910. OSHA requirements directly applicable to the manufacturing, processing, distribution and disposal of nanomaterials include the Act’s general and special duty clauses, as well as specific regulations dealing with: hazardous materials handling, hazard communications (including labels and MSDSs), engineering controls, administrative controls, and personal protective equipment.

Maintaining current knowledge of the state-of the art in nanomaterial safety research is imperative for risk managers, insurance professionals, and their attorneys because the Act’s general duty clause requires that an employer must provide each employee with “a place of employment . . . free from recognized hazards that are likely to cause death or serious physical harm.” 29 U.S.C. §654(a)(1). What is a “recognized” hazard? That language has been held to comprise a standard by which an employer is judged by its own actual knowledge of any workplace hazards as well as the knowledge of the employer’s industry with respect to those hazards. That means that an employer is required to assess and stay abreast of the general knowledge of any nanomaterial hazards that are likely to cause death or serious physical harm to its employees, and to take action to mitigate those hazards. Given the undeveloped state of nanomaterial hazard scientific research, it is currently difficult for most employers to determine whether nanomaterials in use at their facilities constitute a hazardous substance under OSHA and its regulations. This is an especially important subject for guidance from legal counsel with current nanomaterial hazard expertise.

Despite the lack of regulatory guidance, private industry and NGO’s have forged ahead in developing risk reduction frameworks and best practices to protect workers and others. A good example of successful industry-NGO collaboration is the Nano Risk Framework, developed jointly by DuPont Company and Environmental Defense and introduced in June 2007, at http://www.nanoriskframework.com. A valuable resource for anyone developing strategies to keep nanotechnology-related workplace risks low, in order to ensure workplace safety and prevent or limit liability, is ASTM International’s “Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings,” E2535, published in October 2007, at http://www.astm.org/Standards/E2535.htm. The E2535 Handling Guide proceeds from the precautionary principle and provides comprehensive recommendations for a risk assessment and minimization program using standard industrial hygiene principles and applying hazard communication concepts. Another valuable recent contribution is the British Standards Institution’s “Guide to Safe Handling and Disposal of Manufactured Nanomaterials,” PD 6699-2:2007. Available for download at http://community.safenano.org/blogs/andrew_maynard/ archive/2008/01/18/safe-nanotechnology-in-the-workplace-a-practical-guide.aspx, the BSI Guide was published in January 2008 and is helpful for anyone currently developing, producing, handling, or otherwise working with engineered nanomaterials

Nanotechnology Risk Perception: Why it is Critical

Mon, 21 Sep 2009 09:00:00 GMT

The scientific assessment and measurement of risk is critically important in the mass tort field, i.e., determining actual risk to health based on chemistry, toxicology, epidemiology, and the like. But hard science is not the only variable in the multivariate mass tort litigation problem. Another significant factor that impacts mass tort and exposure litigation is perceived risk. That term is distinguished from “actual risk,” i.e., risk level determined by relevant scientists using the scientific method.

Greek philosopher Epictetus observed: "People are disturbed, not by things, but by the view they take of them." Risk perception research offers insights into likely public reaction to nanoscience and nanotechnologies, which has implications for nanomaterial litigation trends. Researchers have found that risks have certain shared characteristics that play a key role in shaping risk perception, aside from scientific facts and statistical probabilities of actual risk. These affective/emotional characteristics form the subconscious backdrop by which we decide what to be afraid of and how afraid to be. If the promise of nanotechnologies is to be fully realized, consideration of the way the public feels about and reacts to nanotechnology – risk perception – will be as important as the results of the actual scientific research into health and environmental safety.

In recognition that the future of nanotechnology will be determined in large measure by the public’s perception of risks and benefits, the National Science Foundation and the Project on Emerging Technologies at the Woodrow Wilson International Center for Scholars are supporting a series of research studies to determine how the public’s perceptions of potential nanotechnology benefits and risks are likely to evolve. The first two studies in the series have been completed. See Kahan, et al., Biased Assimilation, Polarization, and Cultural Credibility: An Experimental Study of Nanotechnology Risk Perceptions, Woodrow Wilson International Center Project on Emerging Nanotechnologies Research Brief No. 3, Feb 2008, at http://www.nanotechproject.org/process/assets/files/5960/brief2kahan_final.pdf; and Kahan, et al., Nanotechnology Risk Perceptions: The Influence of Affect and Values, Cultural Cognition Project at Yale Law School, March 2007, at http://www.nanotechproject.org/process/assets/files/2710/164_nanotechriskperceptions_dankahan.pdf.

These studies are not aimed at promoting any particular view, but are motivated by a desire to identify concrete steps that scientists, regulators, and others – such as those in the nanotechnology industry – can take to assure that the public’s assessment of nanotechnology’s risks and benefits accurately reflects the best scientific information currently available and that will become available as the evaluation of nanotechnology continues. Likewise, risk perception will play a significant role in the development of initial governmental regulatory schemes that will impact the nanotort litigation playing field. If public and governmental apprehension about nanotechnology risk builds, the likelihood of mass tort and other nano-exposure litigation increases.

Risk perception influences litigation, especially in the areas of mass torts and toxic exposure litigation, and a product manufacturer’s most responsible risk management and product safety systems will not always ensure avoidance of litigation and even liability. Manufacturers have been, and no doubt will continue to be, confronted with irrational triggers to risk. Societal fear of "phantom" risk – where no scientifically demonstrable cause-effect relationship can yet be established – can drive regulatory and liability conditions. One need look no further than the silicone gel mania even though the related breast implants were ultimately determined to be essentially harmless. The experience with the synthetic pesticide DDT (Dichloro-Diphenyl-Trichloroethane) is also instructive. Swiss scientist Paul Hermann Müller was awarded the 1948 Nobel Prize in Physiology and Medicine for his efforts in developing the insecticidal properties of DDT. DDT was used with great effect to control mosquitoes spreading malaria, typhus, and other insect-borne diseases and is largely credited with eradicating malaria from Europe and North America. DDT was also made available for use as an agricultural insecticide, and soon its production and use skyrocketed around the world. In 1962, Silent Spring by American biologist Rachel Carson was published. The book argued that pesticides, and especially DDT, were poisoning wildlife and endangering human health, and questioned the wisdom of releasing large amounts of chemicals into the environment without fully understanding their effects on ecology or human health. Although Silent Spring received little support from the mainstream scientific community at the time, DDT became a prime target of the growing anti-chemical and anti-pesticide movements, resulting in perceived risk overwhelming the science. The resulting political pressure led to most uses of DDT being banned in the U.S. in 1972.

The risk perception concern is especially valid in connection with emerging nanotechnologies because they bear the hallmarks of the risks that make us most afraid: it is a man-made risk rather than a naturally occurring risk; nanotechnologies are hard to comprehend because they are scientifically complex, invisible, and not yet completely studied and understood; there will be limited ability to control exposure to nanomaterials; and it is new technology rather than something we have experience with. Fear is driven by these risk perception factors, which can be perpetuated and magnified by media sensationalism, anti-chemical and anti-technology Internet bloggers, special interest group agendas, and political forces, even in the face of the developing science and facts concerning actual risk.

The prospect is real that various nano-scares could emerge in the future – fueled by message boards, blogs, interest group web sites and the traditional media. Therein lies the heightened danger of perceived risk in the Age of Nanotechnology. Risk perception, even when not supported by science, can lead to political pressure, government action, and can sow seeds of potential personal injury litigation. For nanotechnologies, these psychological and sociological phenomena will be powerful forces to be monitored by mass tort lawyers just as with the hard risk assessment science. Rational discourse will be important. To that end, mass tort and toxic tort lawyers will be important players in ensuring that irrational risk perception and the impact of nanotort litigation does not stifle otherwise beneficial technology.

NanoTorts: The Next Big Thing

Sun, 20 Sep 2009 12:00:00 GMT

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

The societal benefits from nanotechnologies are expected to be greater than the combined effects of microelectronics, medical imaging, computer-aided engineering, and man-made polymers developed in the 20th century. Within a few short decades, nanotechnology has the potential to deliver revolutionary advances – amazing, economy-disrupting, life-changing advances – in almost every facet of our lives. Yet few lawyers and risk managers understand what nanotechnology is and even fewer have a grasp of how the nanotechnology revolution will take place and the potential influence of tort litigation. Daubert v. Merrell Dow Pharmaceuticals hastened the assimilation of scientific understanding into the law, requiring that lawyers have sufficient expertise to understand, assess, and explain science. In the coming Age, litigating nanotechnology-related claims will require that judges and lawyers become even more sophisticated con¬sumers of science. The revolutionary changes expected to be brought about by nanotechnology will play out within the established framework of American tort liability law that has accommodated and addressed every emerging technology of the past. Risk managers, the insurance industry, and mass tort and toxic exposure lawyers have important roles to play in the realm of nano-risk perception as well as in nanotort litigation; roles that could significantly impact the degree to which the fantastic economic and societal benefits of nanotechnologies are realized.

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.