The FDA is on the move.  OnApril 20, 2012, it issued two draft guidances pertaining to the effects of nanotechnology on food and cosmetics.  In the cosmetics document, the FDA cautions safety and does little more.  But in the food safety document, the FDA moves in the directing of setting forth steps to be taken by food manufacturers to prove the safety of any food and food packaging using nanotechnology.  This heightened scrutiny for food products containing nanoparticles is an affirmative move on the part of the FDA to regulate nanotechnology.

 In the April 20 food safety guidance document, the FDA states:

 “The manufacturing process of a food substance is considered for the purposes of safety assessment only insofar as it may affect the properties and safety of the finished product.”

 The FDA goes on to say that “[t]he particle size distribution of a food substance may affect its ability to be absorbed by the body or to migrate from food packaging into food.”  The FDA explicitly states that manufacturing processes involving nanotechnology are included within the scope of the guidance document.

 The FDA states that it does not intend to judge any substances containing nanoparticles as being harmful – or not – but that use of nanotechnology in food may warrant certain assessments in determining the safety of the food.  The FDA states:

 “The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. . . . For example, so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”

In other words, safety assessments in this area should be based on criteria for food substances in the nanometer range, and that could require new and different assessment methodologies.  However, the FDA has said that it will continue to regulate nanotechnology products under its existing statutory authorities, e.g. regulations on food color, additives, and packaging.

So does the guidance represent a step forward?  I think it does, if for no other reason than it explicitly recognizes that there may be discrete safety issues raised by the use of nanotechnology in food.  The guidance is not self-executing; it is currently available for public comment.  It represents a step in the right direction.  Its recommendations are preliminary, it seems to me.  Going forward, further consideration needs to be given to the issues it raises to determine if regulation specific to products using nanotechnology is warranted.  This should be only the beginning.


The draft guidance is Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, available at



white-house-south-2007-djIn my most recent entry, I noted that the National Academies would be releasing a report by the end of January that focuses on researching the health and safety aspects of nanotechnology.  The report, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, was released January 25 in prepublication (i.e. uncorrected) copy.  A download, with significant restrictions, is available at

The study was initiated by EPA, which asked the National Research Council of the National Academies to conduct an independent study with the goal of developing a research strategy.  The report sets forth a conceptual framework for research on the environmental, health, and safety impacts of engineered nanomaterials (ENMs).

 The report explains why ENMs are difficult to place into a system of risk analysis.  In this blog, I’ve discussed the fact that the tiny size of nanomaterials gives them characteristics and risks different from the same materials in larger dimensions.  The report points out the vast diversity of characteristics of ENMs, as well as the fact that those characteristics may behave differently depending upon the environment in which the materials are located, including changing characteristics as the nanoparticles migrate.  Furthermore, the uncertainty about risks in all sectors – among developers, regulators, and consumers – demands a uniform strategy for assessing risks.  The report points out that little research has been done to date, notwithstanding the fact that even more complex ENMs will soon be available.

In other words, we needed a research protocol for identifying, analyzing, and managing the environmental, health, and safety hazards of ENMs yesterday.

One of the most significant points made in the report was the identification of “critical research gaps” that must be addressed.  Examples of some of the gaps:

More is known about inhalation risks than other routes of exposure because of earlier research on the effects of particle inhalation on the human body.

Basic information is lacking on the chemical and physical properties of the ENMs currently out there.

Gaps in knowledge exist regarding how ENMs move through and interact with the human body and in the environment.

How research is conducted in the laboratory must be modified to provide accurate information about the risks.  Standard testing protocols must be developed.

 The report goes on, and in the months to come I will look at various aspects of the report in individual posts on this blog. 

 Consistent with its findings, the report recommended changing the structure of the National Nanotechnology Initiative (NNI), which is too vast and fragmented to be effective in the ways that are critical.  The NNI’s authority covers essentially only coordination functions.  The report recommends that the entity that manages and implements the report’s strategy be one with “top-down” management and budget authority over the research.  This may not be the NNI at all.  The report notes that the NNI’s objective of promoting the development and uses of nanomaterials may conflict with its role in identifying and appropriately managing the risks of the technology.  Accordingly, the report recommends separating those objectives and restructuring the NNI.

It’s another beginning.  The follow-up report, in which the committee promised to assess progress toward the goals set forth in this report, isn’t due for a couple of years.  In the meantime, ENMs will continue to proliferate.  My recommendation is that all sectors exercise all due caution until more is known.

ref1394_x180-fThe National Academies have promised a report by the end of January 2012 on priorities (both short- and long-term) for studying the health, safety, and environmental effects of nanotechnology.  According to the National Academies, this report will address the following matters:  the properties of engineered nanomaterials; methods and technologies for “detecting, measuring, analyzing, and monitoring” engineered nanomaterials; what studies are needed; what testing methods need to be developed; the models for predicting impacts that should be developed; research priorities; and the criteria for evaluating research progress.  In its “Statement of Task,” the National Research Council has explained:

“The committee will take into consideration current and emerging uses of engineered nanomaterials and the scientific uncertainties related to physical and chemical properties, potential exposures, toxicity, toxicokinetics, and environmental fate of these materials.”

I will discuss the report when it is issued.  More information on the National Academies’ research strategy is available at

This is a promising developing to look forward to, but as with all things, the proof is in the, er, nanopudding (sorry, couldn’t resist).  Initiating a task such as this is daunting, with the result a framework for assessment, not the ultimate assessment.  But it is a necessary step in what is certain to be a long process.

In a separate project, the National Academies are considering more than the health, safety, and environmental effects of nanotechnology.  Pursuant to the Nanotechnology Research and Development Act (Pub. L. No. 108-153), Congress has mandated triennial reviews of the National Nanotechnology Initiative (NNI).  The National Academies’ National Research Council convened a committee to conduct the second such triennial review, and its report is due in 2013.  Much of the review will entail examining the economic impact of nanotechnology and ways to measure the value of nanotechnologies.

Information on the triennial review project is available at

The two projects discussed in this post demonstrate the efforts to address the two important aspects of progress in the uses of nanotechnology – understanding the health, safety, and environmental effects, and measuring the economic benefits of nanotechnology.

chip-makerAn interesting and potentially revolutionary development in magnetic storage of data was announced a couple of weeks ago.  Researchers at I.B.M. have reported the development of a new class of nanomaterials that could lead to the development of new, significantly smaller memory chips and disk drives that will both hold vast amounts of information and use less power than the current class of silicon chips.  The report (Loth, Baumann, Lutz, Eigler, and Heinrich, Bistability in Atomic-Scale Antiferromagnets) appears in the journal Science at Vol. 335, no. 6065, pp. 196-99 (Jan. 13, 2012), and has been widely reported in the news media.  There is much excitement over this development, both for its inherent promise for data storage and for its potential in other areas.  Analysts have suggested that other new nanomaterials may be forthcoming using some of the same general methodologies and approaches of these researchers.

 Among other media sources, this development has been reported in the New York Times:

John Markoff, “New Storage Device is Very Small, at 12 Atoms,” N.Y. Times, Jan. 12, 2012, available at

So while we are wowed by such progress, it only begs the same old question of what should be done to determine the hazards that the technology might pose to workers, the general public, and the environment.  As with so many of the technological developments using nanomaterials, there is little discussion of potential hazards at this juncture.  But when will we give some serious thought to them?  After the products are developed and marketed?  After adverse effects are manifested?  So maybe there won’t be any adverse effects.  But do we know that as we continue to be dazzled by the potential technological developments in the nanoworld?  At the risk of sounding very non-technological, maybe we need to refer back to that old adage – better to be safe than sorry.

prod liab imageIt had to happen sooner or later.  And it’s happening now.  A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA).  The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products.  The requested relief is detailed on pages 3-4 of the petition.  The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).

The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.

Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment.  This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure.  Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.

In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners.  There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.

The greatest significance of this lawsuit is that it puts nanotechnology into the courts.  This may be the first time, but it certainly won’t be the last time.

The 80-page petition is available at

The 2007 Nanotechnology Task Force report is available at

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.

ef_2009_345796_1 US CapitolFor those of you who are following this blog, I’ll apologize for letting nearly two months slip away since the previous post.  The reason has to do with my co-blogger, Eric Laury.  After passing both the Pennsylvania and New Jersey bar exams, Eric took a job in a law firm in Denver, which means he is now studying for the Colorado bar exam.  I have every reason to believe that Eric will resume writing for this blog after things settled down for him, but likely as an occasional blogger.  I congratulate him on his success and look forward to our continued collaboration.

Among this week’s news in the world of nanotechnology law is word that the U.S. government is in the grip of regulatory confusion.  If you’ve been reading this blog, that’s nothing new, but there now seems to be official consensus that there is no consensus.

This consensus on non-consensus was a major focus of a workshop in Washington on December 13 and 14 organized by the National Institute of Standards and Technology (NIST) and the American National Standards Institute (ANSI).  One of the themes of the workshop came from several participants, including EPA which noted that there is no agreement internationally on either toxicity testing protocols or the proper methodology for measuring release of nanoparticles into the environment.  A similar theme was pressed by the CPSC.  The chair of the Nanotechnology Panel of the American Chemistry Council echoed the concerns of the governmental agencies, emphasizing that industry needs to have clear rules to develop safe products.

Moreover, the participants expressed concern for the disconnect between the various sectors – government, business, and consumers – over the need for and type of regulation for the products of nanotechnology.

All well and good.  But this workshop has that déjà vu feeling.  Haven’t we been hearing this over and over for some time now?  It also has a certain circular logic to it, which goes something like this:  “Before we regulate, we need to know what the hazards are and what to regulate, but if we can’t agree on how to assess the hazards and what needs to be regulated, then we can’t regulate.”

 Think about it.

 The following article reported the events of the workshop:

Pat Rizzuto, Regulators Say They Lack Consensus-Based Standards for Key Aspects of Nanomaterials, 241 Daily Envt’l Rep. (BNA) A-8 (Dec. 15, 2011) (by subscription only)

nano 4It’s been a long time coming, but the European Commission published its definition of nanomaterials on October 18, 2011.  Though not binding on EU member countries, this is a major step toward the use of a uniform definition throughout the EU and – who knows? – elsewhere in the world.  The Commission adopted the following previously recommended definition of “nanomaterial”:

 “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm”

 The Recommendation containing the definition and further definitions of terms used within it are available at

Further review of the definition is to be conducted by December 2014 on the belief that nanotechnology will continue to develop and evolve, and the definition may require adjustment.  “Technological development and scientific progress continue with great speed,” the Commission stated.  (Recommendation, p. 4)

 This is good news.  It has important immediate ramifications for the EU’s REACH chemical regulation which currently does not regulate based on scale.  The Commission stated in its recommendation that “[t]he definition . . . should be used as a reference for determining whether a material should be considered as a ‘nanomaterial’ for legislative and policy purposes in the Union.”  (Recommendation, p. 2)

 In September, a joint report of the European Academies Science Advisory Council (EASAC) and the EU’s Joint Research Centre (JRC) of the Institute for Health and Consumer Protection (IHCP) was published.  The report was on the “Impact of Engineered Nanomaterials on Health:  Considerations for Benefit-Risk Assessment.”  Referring to “continuing scientific uncertainty” regarding the safety of nanomaterials, the Joint Report stressed the need for “timely policy development.”  (Joint Report, p. 5)  The Joint Report concluded that:

“A clear regulatory framework to address potential health and environmental impacts, within the wider context of evaluating and communicating the benefit-risk balance, must be a core part of Europe’s integrated efforts for nanotechnology innovation.

. . .

We conclude that it is essential to invest significantly in research for safety assessment while seeking to expedite regulatory review of the products emanating from that science.”

 (Joint Report, p. 5)

 The Joint Report is available at

 There is much to consider in the Joint Report, and I will address some of its observations and recommendations in future posts.  Suffice it to say, however, that the European Commission’s adoption of the nanomaterial definition comes at a particularly appropriate time, in light of the Joint Report.  We will continue to follow developments in the EU on this front.

asbestos-fibreI have written here about various ways in which nanomaterials may be comparable to asbestos – both in the ways nanoparticles may impact the human body and the ways the law may respond.  So it’s not surprising that one more comparison has emerged recently.

 Scientists from Brown University have studied the impact of carbon nanotubes on mouse cells.  Their study, published in the September 19, 2011 issue of Nature Nanotechnology, showed that certain types of multi-walled carbon nanotubes enter cells in a way that causes an immune response and cellular inflammation.  The physical properties of the nanotubes are responsible for this reaction.  As the researchers stated in their abstract, “cylindrical one-dimensional nanomaterials such as carbon nanotubes enter cells through the tip first.”  Certain nanotubes – those with end caps or carbon shells at their tips – seem to trigger the inflammatory reaction.  The researchers mention asbestos fibers in their abstract as being analogous (though they are clearly physically different) in this important aspect.

Does this mean that carbon nanotubes will create the same health problems that asbestos created?  Not necessarily.  Some might consider asbestos-related illness to be one of the major scourges of the last quarter of the 20th Century and well beyond.  Asbestos has shaped the law in relation to workplace safety and mass tort litigation, and has transformed industry.  Asbestos is a naturally occurring substance, and its use has been limited since the 1970s.  Its health effects, however, are ongoing because symptoms of asbestos-related disease typically occur after a latency period that may be quite long.

Nanomaterials, however, are engineered and represent new technology in a new technological world.  A new response is warranted.  What can be done going forward?  Scientists may be able to engineer carbon nanotubes in a way that will eliminate this particular inflammatory response.  But more research needs to be done before that.  For example, these same researchers intend to study whether nanotubes with others types of tips create the same or similar cellular response.

For now, we may be heading in the direction of “intelligent tip modification,” as the researchers refer to it.  Let’s hope we aren’t headed down the asbestos road again.


The abstract of the article may be accessed at


For a report on the Brown University study, see the following piece in the BNA subscription service:

Greg Hellman, Researchers Show How Carbon Nanotubes Pierce Cells, Leading to Inflammation, 18 Daily Env’t Rep. (BNA) A-12 (Sept. 20, 2011).

Wondering where we’ve been for the past month?

 My summer was spent thinking and writing about technology – all sorts of technology.  It got me thinking about how technology has changed our lives and how it is poised to change all aspects of the law.  Let me share with you my summer projects, which go well beyond nanotechnology issues.  I hope it will enable me to put the legal issues of nanotechnology in a broader context going forward.

 1.  Neuroscience and Tort Law.  I and my co-author (and co-blogger) Eric Laury embarked upon a project more than a year ago to examine how the so-called “new neuroscience” will impact tort law.  By “new neuroscience” we mean mostly functional neuroimaging (fMRI and SPECT), but also any other neuroscientific methods to examine the human brain, including brain wave technology.   Our approach to this extensive law review article was both doctrinal (i.e. how the new neuroscience will eventually change the rules of tort doctrine) and practical (i.e. the problems of incorporating it in tort litigation, particularly under the rules of evidence).  We spent a lot of time predicting the effect that the new neuroscience will eventually have in the courtroom.  Professor Stephen Morse at UPenn Law School has pointed out that much of what we currently know as legal doctrine is based upon “folk psychology” – that is, what we believe causes people to act the way they do.  The new neuroscience will eventually change the law by changing our understanding of human behavior.

 2.  Cell Phones.  I also found myself writing a piece on cell phones and product liability.  In particular, I looked at whether actions claiming the telecommunications industry should be marketing cell phones with headsets to protect against the hazards of radio frequency (“RF”) emissions should be allowed, or whether they are preempted by regulations granting the FCC the authority to set radiation standards for cell phones.  The question, it turns out, it much more complicated than one might think and involves several federal statutes and regulations, including the two major statutes governing the wireless networks in this country.  The Supreme Court will consider a petition for certiorari in Farina v. Nokia, 625 F.3d 97 (3d Cir. 2010), early in the new term.  Even if cert is not granted, this topic likely will continue to make waves in the courts.  My article appears on the BNA subscription service at 39 Prod. Safety & Liab. Rep. (BNA) 871 (Aug. 5, 2011) and 26 Toxics L. Rep. (BNA) 949 (Aug. 10, 2011).  It also appears in U.S. Law Week at 80 U.S.L.W. 321 (Sept. 13, 2011).

 3.  Nanotechnology and the Environment.   I also wrote a short article to be published in the “Insight” section of the upcoming Natural Resources & Environment journal, which is the journal of the ABA Environmental Law Section.  My goal was to alert attorneys to some of the regulatory initiatives either in the works or in the pipeline.  The piece focuses on TSCA, FIFRA, OSHA, and foreign initiatives (EU, Australia).  It was interesting to look at the impact of nanomaterials exclusively from the environmental (outdoors and indoors) perspective.

So while I may not have been spending a lot of time blogging about nanotechnology and the law, I was busy getting the bigger picture on technology.