Category: Nanotubes

Many of the posts on this blog have addressed the regulation dilemma of whether to incorporate nanomaterials into the existing regulatory framework or develop separate regulations to manage their potential hazards.  This same dilemma is playing out in a slightly different way through a public-private partnership on exposures to carbon nanotubes in consumer products.

The NanoRelease project is engaged in this effort, with the support of numerous organizations, including U.S. EPA, Environment Canada, HealthCanada, and the American Chemistry Council.  Undertaken by the Government of Canada, the project has selected multi-walled carbon nanotubes in polymer to begin its study of the nature of exposures to nanomaterials.  The study includes determining likely release scenarios, evaluating release measurements, and considering needs for laboratory testing.  The research foundation has stated:  “The NanoRelease project will foster the safe development of nanomaterials by supporting development of methods to understand the release of nanomaterials used in products.”  Among other things, the group pledges to develop a “state of the science” report.

A summary of the project is available at

Both the National Institute of Occupational Safety and Health (NIOSH) and the Consumer Product Safety Commission (CPSC) are very interested in the ongoing process.  But will the ultimate result be “consensus standards” for nanomaterials that are efficient and effective?  Will consensus standards be followed by industry without a direct mandate?

Bloomberg BNA’s Daily Environment Reporter quoted John Howard, the director of NIOSH, as saying:  “We want to make sure that if we are developing consensus standards . . . that people are reading them and that people are adhering to them.  Otherwise heavy-handed government regulation – that industry always objects to – will come into fore and then we’ll have a less effective control system, a less efficient risk management system.”  (quoted in Pat Rizzuto, Regulators, Industry Sorting Through Potential Exposures to Carbon Nanotubes, 122 Daily Env’t Rep. (BNA) A-9 (June 26, 2012) (by subscription))

Will industry and governments agree on standards?  If so, some measure of regulation will be necessary, but probably not the “heavy-handed” sort that concerned Dr. Howard.  Consensus standards can be incorporated into existing regulatory regimes, perhaps rendering unnecessary separate extensive regulation for nanomaterials.  But essentially we are circling the same issue over and over again:  Is it possible to avoid separate, independent, and perhaps “heavy-handed” regulation of nanomaterials in the interest of public health and safety?  No question that it is an important issue.  And it remains unanswered.

imagesThe National Institute of Standards and Technology (NIST) has issued what is being touted as the world’s first reference material for single-wall carbon nanotube soot.  In its statement, NIST calls single-wall carbon nanotubes (SWCNT) “perhaps the archetype of all nanoscale materials.”  The promise of SWCNT in industrial use is great (NIST chemical engineer Jeffrey Fagan stated that “full development of these materials should enable lighter, stronger materials, as well as improve many technologies from sensors to electronics and batteries”).  But as with most things, there’s a catch.

Production of SWCNT involves a complex process that is known for inconsistent quality, variability from batch to batch, and significant resulting impurities.  NIST has sought to provide the first standardized guidelines – both chemical and metric – to the production of nanotubes, through the publication of its Standard Reference Material SRM 2483 – Single-Wall Carbon Nanotubes (Raw Soot) on December 20, 2011.  The purpose of the SRM is to provide industrial developers and producers with a means to evaluate chemical and instrumental methods of analysis of carbon nanotubes with the goal of improving quality and consistency across the board.

Of special interest to me is the Material Safety Data Sheet (MSDS) for SWCNT raw soot, which was simultaneously issued by NIST.  The MSDS reveals that little is known about the potential hazards of this substance in the workplace setting.  The MSDS contains the following statement regarding single-wall carbon nanotubes raw soot:

“According to NIOSH, currently there are no studies reported in the literature of adverse health effects in workers producing or using carbon nanotubes or carbon nanofibers.  The concern about worker exposure to these materials arises from results of animal studies.  Several studies in rodents have shown an equal or greater potency of carbon nanotubes compared to other inhaled particles known to be hazardous to exposed workers (ultrafine carbon black, crystalline silica, and asbestos) in causing adverse lung effects including pulmonary inflammation and fibrosis.”

Did the word “asbestos” jump off the page?  And just because this substance is not listed as a potential carcinogen in the National Toxicology Program (NTP) Report on Carcinogens, the International Agency for Research on Cancer (IARC) Monographs, or by OSHA does not mean that it doesn’t pose a significant health risk to workers.  Pulmonary fibrosis, in the form of asbestosis and silicosis, has been a major public health problem for decades and a legal problem of immeasurable proportions.

Furthermore, the MSDS states, under Toxicology Information, that “[a]nimal in vitro cell studies have shown that SWCNT can cause genotoxicity and abnormal chromosome number due to interference with mitosis.”  But the research has not yet demonstrated any effects in the animals other than the observed impact, perhaps because the technology is so new and the research in its infancy.

Under Ecotoxicity Data, the MSDS states, “No data available.”

Clearly, there is an urgent need for more study of the potential health hazards of SWCNT, both acute and chronic.  So while the Standard Reference Material is a giant step toward consistency of standards, the MSDS reveals that it is only a baby step in the larger scheme of things.  Much research needs to be done on the impact of these new technologies on workers and ultimately on consumers and the environment.

The NIST statement, with image, is available at

The Standard Reference Material is available at

The MSDS, with sources, is available through a link from the Standard Reference Material page immediately above.

asbestos-fibreEarlier, I wrote about some potential similarities between asbestos personal injury litigation and the litigation that is certain to come over nanoparticles and human health.  I will be writing on and off about this topic going forward as well.  I can’t emphasize enough the urgency of avoiding another disaster like asbestos litigation, which has clogged the courts since the 1970s.

For example, engineered nanomaterials are being placed into building materials.  In the first instance, these materials are being designed and manufactured in the primary workplace environment, thus potentially exposing workers to hazards about which little or nothing is known.  Another set of workers, those using the building materials in the secondary workplace, run the risk of exposure to potentially harmful substances.

The history of asbestos shows that the early studies were conducted on asbestos textile factory workers, but that meaningful studies on workers out in the field who were installing the materials lagged far behind.  Then, when the studies began to raise danger signals, the industry ignored those signals until the specter of mass litigation and government regulation forced recognition.  By then it was too late.

Nanomaterials present some of the same workplace issues, particularly when used in building materials.  The hazards of the primary workplace may be different from those in the secondary workplace.  Studies must be conducted on both types of environments.

Further, there is a third concern, which also mirrors the asbestos experience.  At some point down the line (years or decades), the anticipated life of the materials will expire, just as asbestos insulation materials have done.  At that point, degeneration of the materials could put nanomaterials into the environment to a degree that could endanger the safety of persons in the vicinity.

In the case of nanomaterials, do we know any of this for certain?  No.  But at the present time we know almost nothing about any of these safety issues.  In December, the National Institute for Occupational Safety and Health (NIOSH) proposed a workplace exposure limit for carbon nanotubes and nanofibers.  This is a start; but without hard data, it is really only a guess.  And it is not necessarily consistent with limits for other substances.

While the industries creating and using nanomaterials will likely take seriously the lessons of asbestos, more should be done up front to ascertain the seriousness and scope of the hazards that the materials may present.  Now is the time.  If the hazards outrun the studies, the finish line will be litigation.

Lab beakerMy previous post began a conversation about applying the evidentiary rules for admissibility of scientific studies and expert testimony to the emerging studies on the health and environmental effects of nanomaterials, all in the context of the toxic tort litigation that is soon to come.  This post will continue that conversation by looking at the legal rules to determine the reliability and scientific validity of such studies.  In particular, this post will look at the Frye rule and its continuing viability in a significant minority of jurisdictions.

Under the older Frye rule, reliability was determined solely by whether the scientific technique has achieved “general acceptance in the particular field in which it belongs.”  Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).  States that have adopted and continue to apply the Frye test for admissibility of expert evidence have further clarified and refined the rule.  Thus, the Minnesota Supreme Court stated in Goeb v. Tharaldson, 615 N.W.2d 800, 810 (Minn. 2000), that a two-pronged test would apply:  “First, [the] technique must be generally accepted in the relevant scientific community, and second, the particular evidence derived from that test must have a foundation that is scientifically reliable.”  In Goeb, the plaintiffs alleged that their son had suffered permanent injuries from exposure to a pesticide that had been applied in their residence.  The court agreed that the trial court had properly excluded the plaintiffs’ expert scientific evidence of causation because the scientific methodology used was not generally accepted and because the expert’s analysis had no “independent validation.”

The Frye rule has frequently been criticized, however.  Thus, the Alaska Supreme Court (in a case adopting the Daubert rule and the federal evidentiary standard), has criticized Frye as incorrectly favoring the conclusions of scientists over courts in matters of a legal nature, arguing that it “ ‘abdicates’ judicial responsibility for determining admissibility to scientists uneducated in the law.” See State v. Coon, 974 P.2d 386, 392, 394-95 (Alaska 1999).  The Minnesota Supreme Court countered this argument by stating that “the Frye general acceptance standard ensures that the persons most qualified to assess scientific validity of a technique have the determinative voice.”  Goeb, at 813.  In Blackwell v. Wyeth, 971 A.2d 235 (Md. 2009), the Maryland Court of Appeals established a compromise rule.  In Blackwell, the plaintiffs alleged that their child’s autism was caused by thimerosal in childhood vaccines.  The court reaffirmed its adherence to the Frye doctrine, characterizing the doctrine in Maryland as requiring that “[g]enerally accepted methodology . . . must be coupled with generally accepted analysis” by the expert.  This approach thus assures that the trial judge has the final word on acceptance of the evidence.

The debate continues, however, over whether the Frye doctrine relies on excessive deference to the scientific community on matters of a legal nature.  This disagreement is not likely to be resolved soon and is reflected in the split in the states over the adoption of the Daubert rule, which, in contrast, is heavily dependent on judges to evaluate the scientific evidence.

What will happen to nanotechnology studies in a Frye jurisdiction?

The answer may depend on whether the studies are viewed as new and untested because they involve materials at a scale that has generally not been previously studied for health and environmental impacts.  Frye does not favor new technologies.  Frye admissibility is premised upon a history of the technologies that has evolved to the point of receiving general acceptance in the particular scientific community.

On the other hand, an argument could be made that such studies are simply versions of well-established and generally accepted scientific studies, whether of an epidemiological nature (statistical studies of human populations) or a toxicological nature (such as studies on mice conducted in a laboratory).  It is worth noting, too, that studies of human populations generally take much longer to develop, and nanomaterials measurable in consumer products and the environment are a relatively new occurrence in the scheme of things.  Thus, the studies on nanomaterials now emerging are laboratory experiments.  See, for example, the studies summarized in Powell & Kanarek, Nanomaterial Health Effects – Part 1:  Background and Current Knowledge, 105 Wisc. Med. J. 16 (2006).

In the next post, I will examine the Daubert reliability standard.

nano 3On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review.  The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.

 The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials.  This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology.  It is a critical step toward reducing risks to human health and the environment.  But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.

 In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”

 The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.

The European Union may be further ahead.  On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes.  Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years.  Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.

 Even so, why so slow?  Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.


Sources (all by BNA subscription):

225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)

The course of asbestos litigation is well known, as is the fact that there appears to be no end in sight.  Is nanotechnology producing the next asbestos?  Some groups are working to prevent nanoparticle litigation from following in the steps of asbestos litigation.

In 2009, the United Kingdom’s Institute of Occupational Medicine (IOM) issued a report asking the question whether High Aspect Ratio Nanoparticles (HARN) – most notably, carbon nanotubes – create some of the same health risks as asbestos fibers.  The fiber-like features of HARN, although man-made rather than naturally occurring, may or may not interact with the human body in asbestos-like ways. The importance of determining whether HARN raise similar health risks cannot be overstated.  These issues have yet to be resolved, with potential health risks lurking in the interim.  As is often the case, development of new technology has flown past the scientific community’s ability to determine and assess the technology’s risks.

Looking back at the history of asbestos litigation, some burning questions need resolution sooner rather than later.  For example:

●  Do HARN fibers remain in vivo or do they degrade before disease processes are initiated?

●  If HARN are shown to persist in the body, what is the likely impact on workers?  In the asbestos context, the impact was seen in thousands of workers who developed debilitating progressive obstructive lung disease and/or malignant mesothelioma.  Do HARN have the capacity to produce similar health problems?

●  Even if HARN do not appear to behave directly like asbestos fibers, could HARN cause other, unknown, adverse health effects?

●  What broader impact might HARN have outside the workplace, including consumer and environmental exposures?

Are we headed down the same litigation road with HARN that we traveled with asbestos?

The asbestos litigation debacle in the United States began modestly enough with workers’ compensation claims, which were first denied and eventually routinely paid.  When asbestos insulation workers successfully brought actions against the manufacturers of the products they used in the workplace, the litigation expanded exponentially and has continued to challenge the court systems.

How can we avoid another asbestos?  The answer begins with research, knowledge, and awareness.

I previously commented on the House bill that would amend the Toxic Substances Control Act (TSCA) by updating it to include more substances, more disclosure, and expedited review by EPA.  On July 29, 2010, the House Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection held a hearing on the bill (H.R. 5820).  Certain themes emerged from this hearing.

 Theme 1:  The Economy.

 ●  Jobs.  All agreed that a major goal should be to avoid the loss of more jobs.  This may mean that legislation updating TSCA may proceed more slowly than the current bill would require.  This, in turn, would stall regulation of nanotechnology through TSCA.

 ●  Expense and difficulty of compliance.  Cal Dooley, President and CEO for the American Chemistry Council, representing the large chemical manufacturers in the industry, expressed concern that the increased burden and costs on manufacturers, and the longer time frame for EPA to review submissions, would result in a delay in bringing new chemicals to market and would force manufacturers to other countries.  He stated:  “We would export innovation and jobs instead of products.”

 ●  Foreign competition.  This theme was especially emphasized by Beth D. Bosley on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA), representing small chemical manufacturers.  She argued that H.R. 5820 “poses overwhelming challenges for the industry,” including the loss of innovation and chemical manufacturing to foreign markets.  She feared that the “substantive loss of high-paying manufacturing jobs will result.”

 Theme Two:  Defining a Scientific Standard

 ●  The Hearing indicated that this is certain to be a sticking point in the debate to come over H.R. 5820.

 ●  Cal Dooley of the American Chemistry Council stated:  “[T]he safety standard as established in this bill sets such an impossibly high hurdle for all chemicals in commerce that it would produce technical, bureaucratic, and commercial barriers so significant they would be the law’s undoing.”

 ●  In contrast, Richard Denison, a Senior Scientist of the Environmental Defense Fund, praised H.R. 5820 for assuring that “the best and latest science” be used for risk-based safety determinations.

 Theme Three:  Impact on Industry Innovation

 ●  Some witnesses presented testimony that H.R. 5820 would spur industry innovation by raising U.S. chemical standards to a level that would allow American companies to compete in a global economy where disclosure of information has become important.

 ●  In contrast, as the representatives of the chemical industry argued, concerns exist that innovation in the chemical industry will be exported abroad and that proprietary information will be compromised.

 What about nanotechnology?

 Though not a pervasive theme, the Hearing had some mention of nanotechnology.  Richard Denison, a Senior Scientist with the Environmental Defense Fund, said the following about the current state of nanotechnology regulation:

 “EPA has had little choice but to resort to pleading with the emerging nanotechnology industry to provide, through a voluntary program, the most basic information EPA feels it needs to decide how best to regulate these materials – only to see a level of participation best described as paltry.  Such materials can by no means be assumed to be benign; for example, one class of nanomaterials – multi-walled carbon nanotubes – behaves in a manner that is ominously similar to asbestos.”

 Regulation of nanotechnology is coming, one way or another.  It is time to have a full discussion and debate on how best to achieve that, for the interests of the public, workers, and industry.  Currently, it appears that debate on the bill will resume in earnest when the next Congress convenes.  Let’s hope that the debate addresses these critical questions.

 Transcripts and video from the hearing may be accessed at