Category: Research

nano 6Last week, the news media reported the results of a study conducted by Navy Capt. Mark Lyles, the chair of medical sciences and biotechnology at the Center for Naval Warfare Studies at the Naval War College, which purported to explain the cause of a wide range of symptoms and illnesses experienced by current and former U.S. troops in Iraq, Afghanistan, and Kuwait.  Minute dust particles containing toxic metals, bacteria, and other substances may be responsible for such health problems as cancers, respiratory ailments, heart disease, and neurological conditions in vets.  The key to the particular toxicity of the substances, as contained in the dust, is thought to be the tiny size of the particles.  For various reasons, the dust in that region of the world is much finer than ordinary dust, and the tiny particles are easily inhaled deep into the lungs, where disease processes can begin.

Although these dust particles are not the same as nanoparticles, this study raises a red flag about the need for caution about exposures to nanoparticles, whether in the workplace or the environment.  As repeatedly noted in this blog, the size of nanoparticles is key to their behavior, and some early studies have indicated that toxicity may increase as the size of particles decreases.  As the President’s Cancer Panel stated in its 2008-2009 Annual Report, the small size of nanoparticles means that “they can be inhaled, ingested, and absorbed through the skin, entering the blood stream, penetrating cells throughout the body (including the brain), and perhaps interfering with DNA processes.” (p. 40)  In the environment, the particles could potentially wreak ecological havoc.  Several studies have shown that some kinds of nanoparticles have leached into the environment, thus red-flagging the need for determining exactly how they affect the environment.

It is a fact of contemporary life that devastating results could come from exposure to engineered particles just as much as from biological organisms or a toxic soup of substances in the soil-dust of the planet.  With engineered nanomaterials, it is currently anyone’s guess as to when, how, or if such devastating results could occur.

At best, this new study of war dust is a reminder of the present, urgent need to conduct health and safety studies on nanomaterials.  At worst, it is a portent of things to come.


For a news report on the Navy researcher’s results, see

white-house-south-2007-djWhen it comes to new technologies, government goals are to both encourage innovation and assure the safety of the public.  Achieving the right balance between these goals is often a challenge.

In March 2011, the heads of executive departments and agencies in the federal government received a memo from the Office of Science Technology and Policy, the Office of Information and Regulatory Affairs, and the U.S. Trade Representative elucidating these goals.  Nanotechnology was in the forefront of their thoughts and was mentioned specifically in the first sentence of the memo.  The memo announced the development of broad principles by the White House Emerging Technologies Interagency Policy Coordinating Committee (ETIPC), emphasizing the need for “not only coordinated research and development but also appropriate and balanced oversight.”

The list of broad factors in pursuit of these goals, in the order presented in the memo, is:

●  Scientific Integrity

            ○  Use of best available scientific evidence

            ○  New information should be developed and taken into account

●  Public Participation

            ○  Promoting accountability

●  Communication

            ○  Communicate potential risks and benefits of the technologies to the public

●  Benefits and costs

●  Flexibility

○  To accommodate new information regarding the technologies and their applications

●  Risk assessment and risk management

            ○  Goal of consistency across agencies and across technologies

●  Coordination

            ○  Among agencies, with state authorities, and with stakeholders

●  International cooperation

●  Approach to Regulation

On the subject of regulation, decisions should be based on “the best reasonably obtainable scientific, technical, economic, and other information.”  The memo recommends a risk-utility balancing approach to regulation, and expressly states that sometimes the option will be simply not to regulate.  There is mention of protection of health and the environment, but always as part of a balanced equation with innovation.

These are all appropriate goals.  For each one, however, achieving an appropriate and effective balance will be difficult and time consuming.  In the aggregate, it will mean some considerations will likely be placed on the back burner while others are advanced.  Agencies should be careful not to leave the health and safety concerns behind in the interests of supporting technological innovation.  Regulators should not allow the technology to get too far ahead of risk assessment.  Accordingly, promoting risk assessment should be a major priority.

Perhaps the most important principle is this:  Proceed in such a manner so that there will be no regrets.


The memorandum is available at

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.

nano 6In my previous post, I indicated that I would be moving on to discuss the relevancy arm of the Daubert admissibility test.  It turns out I have a few more thoughts about the reliability arm.

 What does it mean for admissibility purposes when the expert testimony sought to be introduced in litigation is based on an established methodology used in a new context?  This is likely to be an issue when parties seek to introduce studies of the health and safety effects of nanomaterials.    Does such a new subject of a study transform an established methodology into a new and untested methodology?  If so, the evidence would face a much more rigorous level of scrutiny.

 Researchers acknowledge that the state of research on the health and safety aspects of nanomaterials is in its infancy.  Some have noted that due to the costs of obtaining necessary quantities of nanomaterials for animal testing, that type of toxicological testing has given way to the use of more efficient in vitro laboratory tests.  While both animal testing and in vitro tests have been used to test toxicity for a very long time, their reliability in testing chemicals at the nanoscale has yet to be fully assessed.  This could lead to exclusion of the evidence under either the Frye or Daubert analysis, at least until such the use of the studies gains greater reliability.  In other words, courts could view this as a new and untested methodology.

 A related issue is the value of in vitro tests generally in litigation to show a connection between exposures and injuries.  Studies conducted in laboratory containers do not receive high marks from courts generally when introduced to demonstrate causation between an exposure and a person’s injuries.  Courts prefer both epidemiological studies – which determine statistical risks in human populations – and animal bioassays over in vitro studies.

 All of this adds up to some thorny questions that will have to be resolved.

supctThis post continues the discussions in earlier posts about evidentiary standards for admissibility of health and safety studies on nanomaterials under both the Frye standard and the Daubert standard.  I will resume the reliability discussion here, this time focusing on the reliability standards applied in the federal courts and other Daubert jurisdictions.

Under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), reliability of expert scientific evidence is determined in relation to four factors.  These four “general observations” set forth in the Daubert decision were intended to provide guidance to the trial court making a decision about admissibility of expert scientific evidence.  All four need not be favorable to the party seeking admission of the evidence for the evidence to be ruled admissible.  The Supreme Court has said that when it comes to scientific studies, evidentiary reliability is the equivalent of scientific validity.  What makes a scientific study (and the expert testimony relying on it) valid?  The Supreme Court set forth these “general observations”:

 (1)  Whether the scientific theory or technique on which the evidence is based has been tested (presumably by the scientific method);

(2)  Whether the study has been published or has undergone another form of peer review;

(3)  The known or potential rate of scientific error associated with the methodology;

(4)  Whether the methodology has achieved general acceptance in its field.

Although these factors reduce the weight of general acceptance (the sole Frye criterion) in the admissibility analysis, the reality is that the Daubert test has raised the bar in litigation for plaintiffs seeking to have their scientific proof admitted.  These factors are often applied strictly.

Will scientific studies on the health and safety effects of nanomaterials be treated differently under the Daubert reliability analysis than under the Frye general acceptance test?  The primary difficulty under Daubert, as under Frye, is the newness of the studies.

Although the Supreme Court in Daubert said that the focus of the reliability analysis should be on the scientific methodology or technique – and not on the conclusions reached – the Court subsequently modified that statement.  In General Electric Co. v. Joiner, 522 U.S. 136 (1997), the Supreme Court said that “conclusions and methodology are not entirely separate from one another,” thus inviting the trial court to consider the conclusion and whether it constitutes the kind of novel theory that may not be admissible.

It may be true generally that newer methodologies may not have been sufficiently tested, peer reviewed, or accepted in the relevant scientific community, and that they could have a potentially high (or unknown) rate of error.  But one issue that will need to be sorted out in the era of nanostudies will be whether the methodologies for these studies consist of tried-and-true testing methods or, in contrast, will be viewed as novel because of their focus on materials at the nanoscale.  This distinction could make a critical difference in whether such studies will be admitted in litigation in a Daubert jurisdiction.  Tried-and-true carries more admissibility weight.

Perhaps one way to look at this issue – and one that is relevant to the emerging studies of nanomaterials – is the way that a federal district court analyzed the problem in Smith v. General Electric Co., 2004 WL 870832 (D. Mass. 2004).  When confronted with novel and admittedly “controversial” studies, the court concluded that the experts were “serious scientists with controversial views that are in many respects on the periphery of the mainstream, but views that are not so divorced from a scientific method of investigation that they can be dismissed as quackery or armchair conjecture.”  While the district court was likely correct in observing that Daubert did not require or perhaps even empower a court to “determine which of several competing scientific theories has the best provenance,” many would reject the flexible view of Daubert applied in Smith.

Reliability is only part of the admissibility analysis for scientific studies articulated by the Supreme Court in Daubert.  Relevance of the evidence is equally important, and my next post on the subject will look at the relevance of scientific evidence as it has been explained by the Supreme Court in Daubert and Joiner (mentioned above).

Lab beakerA couple of weeks ago, the International Organization for Standardization (ISO) announced the adoption of standards for some testing of nanoparticles.  Specifically the organization, based in Geneva, set standards for studying the inhalation toxicity of these substances.  The United States is a member of the ISO, through the American National Standards Institute (ANSI).  Of course, the new standard has no binding effect on governments and their regulatory agencies, unless it is adopted.

According to the ISO web site, Dr. Peter Hatto, who chairs the ISO technical committee that developed the new standard, explained the need for it:

 “With the rapid expansion of nanotechnology applications comes a growing risk of exposure to potentially toxic substances, especially for workers in nanotechnology-based industries.  Moreover, if airborne nanoparticles were liberated from products, the general public could also be affected.”

Call it an advisory standard.  What is its value then?

●  It’s a start.  And coming from the international community, it will reach across national boundaries, with the possibility that it will generate not just regulations, but a measure of consistency and uniformity from country to country.

●  The statement of Dr. Hatto expressly recognizes the potential hazards for both workers in the nanotechnology industries and for consumers.

●  The standard recognizes that nanoparticles may behave differently from non-nanoscale particles.  Thus, Dr. Hatto said:  “Traditional methods used in other areas are considered insufficient for testing nanoparticles since parameters specific to them like particle surface area or number, might be crucial determinants of toxicity.”  Accordingly, the ISO developed specific methodologies to address these differences and the unique characteristics of nanoparticles.

●  The ISO effort highlights the fact that knowledge of the health and safety risks of nanoparticles is still in its infancy.  As ISO states, “scientists still have a lot to learn about nanoparticles.”

Will the standard be adopted or just be one more effort that is interesting and useful but doesn’t propel the safety efforts forward?

For information on the ISO and the inhalation toxicity standard, ISO 10808:2010, see

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.

NASA stock photos

NASA stock photos

Earlier in this blog I wrote about the need for standardized definitions of nanomaterials so that all enterprises, government agencies, and international organizations can be on the same page when considering the need for regulation or compliance.  The need for consistency and conformity surfaces elsewhere, too, such as in communicating hazards in the workplace.

For some time, the U.S. Occupational Safety and Health Administration (OSHA) has been pondering these issues.  In 2009, OSHA proposed a rule to align the Hazard Communication Standard (which, among other things, classifies hazards and establishes appropriate means of communicating the hazards to workers, such as via Material Safety Data Sheets (MSDSs)) with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  The problem is that not enough is known about the health and safety risks of nanomaterials at the present time, and this lack of knowledge has delayed accurate and appropriate hazard communication.

One issue is the absence of information about nanomaterial hazards on the MSDSs that must accompany chemicals from the manufacturer/importer to the workplaces where the chemicals will be used.  Currently, the U.S. Hazard Communication Standard is silent on this. 29 C.F.R. § 1910.1200. 

The lack of sufficient data has not deterred initiatives in other countries, however.  It has been reported that France has filed a document with the U.N. surveying research on the hazards of nanomaterials that has been carried out by the EU and elsewhere.  China has put into place some compulsory standards implementing the GHS.  And other countries on several continents are in the process of working on the GHS initiative.

In the most recent example, Switzerland issued guidelines in December 2010 to assist industry in providing important information to workers on safety data sheets (SDSs) about the safe handling of synthetic nanomaterials.  State Secretariat for Economic Affairs, Safety Data Sheet (SDS):  Guidelines for Synthetic Nanomaterials (Dec. 21, 2010), available at

The basis for the Swiss action is summarized in its report as follows:

“A conclusive assessment of the risks caused by nano-sized materials is not currently possible, for two reasons.  On the one hand, no conclusive tests have been carried out on a wide variety of nano-objects and micro-sized particles can rarely be transferred onto corresponding nano-objects.  On the other hand, the toxicological test processes which are carried out nowadays can only be applied in a limited scope to nano-sized materials.

 Based on the results of animal experiments, potential damage to health cannot currently be ruled out for certain nano-sized materials.  Nano-particles in certain materials (e.g. flammable or catalytic substances) also conceivably represent a potential risk due to fire, explosions or unexpected chemical reactions.”  (Guidelines, p. 8 )

 Accordingly, the Swiss Guidelines recommend that:

“ •  existing SDSs should be supplemented by nano-specific data as set out in the information on the present document or

•  a separate SDS be drawn up for the nano-objects in question.” (Guidelines, p. 4)

 In the United States, the MSDS is the current gold standard for communicating hazard information to those who handle substances in the workplace.  Because of the possibility that substances at the nano-level may behave differently, it is best to err on the side of safety for workers and the environment.  Although it may not be possible to get every agency and country on the same page immediately, they should all make it a priority to get on page one.  The rest will follow.


Some material for this post was found in

Greg Hellman, Nanotechnology:  Lack of Data may Impede OSHA Plan to Create Hazard Class Aligned with GHS, 40 Occup. Safety & Health Rptr. (BNA) 444 (May 27, 2010) (subscription site)

nano 3On November 30, 2010, the American Industrial Hygiene Association (AIHA), in commenting on the draft 2010 strategic plan of the National Nanotechnology Initiative (NNI), recommended that nanomaterial safety be incorporated in graduate curricula.  AIHA lamented that many recent American graduate school degree recipients are ill-equipped to effectively assess the industrial health and safety risks of nanomaterials in industrial settings.  And, as AIHA pointed out, many recent grads have already had significant exposures to nanomaterials.

 The beginnings of a solution are relatively simple.  AIHA has recommended that the consortium of federal agencies involved in implementing the NNI strategic plan develop guidelines for graduate research programs.  The draft plan itself contains suggestions for actions by the National Institute for Occupational Safety and Health (NIOSH), such as investigation of a broad spectrum of nanomaterials and recommendation of safe exposure limits.

 The full solution may be much more complex, however.

 This issue reminds me of a broader concern that receives news coverage from time to time.  Maybe not often enough.  We frequently hear that the United States continues to lag behind the rest of the developed world in student science performance.  The Organization for Economic Cooperation and Development (OECD), of which the United States is a member, keeps track of such things.  In the most recent rankings of science performance among OECD nations (updated rankings due soon), the United States continued to be below average and ranked 22.

 The bar is being set a little higher for science performance in the schools with the proliferation of nanotechnologies and their highly sophisticated use in many products and medical procedures.  AIHA has said that many newly minted scientists “are unaware of the fundamentals of nanomaterial safety.”  Beyond assuring that nanomaterial safety fundamentals are taught and implemented in graduate programs, nanotechnology and nanomaterial safety should become a part of the basic science curriculum at every relevant level of American education.


Greg Hellman, Industrical Hygienists Say Nanomaterial Safety Should be Part of Graduate Curriculums, BNA Chemical Regulation Rptr, Nov. 30, 2010

 Some information on OECD rankings is available at

The U.S. National Nanotechnology Initiative (NNI) Strategic Plan Draft was posted at for public comment on November 1, 2010.  The NNI was launched in 2001 with 8 agencies and now consists of the nanotechnology-related activities of 25 agencies.  Fifteen of these agencies have R&D budgets related to nanotechnology.

In reflecting on the 10-year history of U.S. nanotechnology research and development, the NNI Draft highlights its work as having “established a thriving nanotechnology R&D environment, laid the crucial groundwork for developing commercial applications and scaling up production, and created demand for many new nanotechnology and manufacturing jobs in the near-term.”  (Draft, p. 1)  Looking to the future, the NNI notes that nanotechnology R&D is “far from full realization.”  (Draft, p. 2)  The goals of the NNI continue to be broad:  continued development of R&D; developing the technologies into products for commercial and consumer use; and developing the physical and human resources to achieve these goals.

Goal 4 of the Draft Strategic Plan is “Support responsible development of nanotechnology,” including the twin goals of understanding and managing the risks of the technologies.  Among the NNI participating agencies in 2010 are EPA, FDA, National Institutes of Health (NIH), and National Institute for Occupational Safety and Health (NIOSH).

The NNI Draft Strategic Plan focuses directly on the benefits of nanotechnology, rather than the risks.  But many of the participating agencies – and many more – need to be involved on the risk side of the proverbial risk-benefit analysis.  This is happening, as reported previously in posts on this blog ranging from FIFRA to TSCA to the FDCA.

 But equally important is the need for communication and coordination on both the benefits and risks of nanotechnology.  And that extends beyond governmental regulation to businesses and nongovernmental organizations (NGOs).

Aside from governmental action, various voluntary initiatives and partnerships have emerged.  A report out of the Woodrow Wilson  International Center for Scholars, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight:  Charting a Path,” gives an overview of the initiatives – some publicly sponsored, some developed by business, and some representing joint business-NGO partnerships.  These initiatives have the common, though separate, goal of developing a strategy to oversee environmental, health, and safety risks raised by nanomaterials.  The report is available at

Three initiatives discussed in some detail in the report are:

 ●  “Nano Risk Framework,” jointly developed by duPont and the Environmental Defense Fund (EDF)

 ●  “Responsible Nano Code,” sponsored by stakeholders from the United Kingdom

 ●  “Nanoscale Materials Stewardship Program,” developed by EPA

 The report critically analyzes these specific initiatives – as well as others more generally – and concludes that they have a welcome role in the future of nanotechnology safety and health efforts.

The ideal world does not exist, of course.  But in this world, a strategy that incorporates the risks and benefits of these developing technologies and brings together as many varied interests as possible representing all affected parties, including the environment, is warranted.  It can provide needed checks and balances along the way.