Category: Environment

NASA stock photos

NASA stock photos

It’s a busy time for potential regulators of nanomaterials.  This post will point to some of the recent activities, in the United States and abroad.

 The Organization for Economic Cooperation and Development’s (OECD) Cooperative Chemical Assessment Program (CoCAP) has long been working to assess the hazards of chemicals across international lines.  OECD has now decided that CoCAP has served its purpose and must be replaced by a different organization at the end of 2014.  One reason for the change is that the activities of the EU’s REACH program and research in the United States have become the primary assessment mechanisms, rendering CoCAP’s current activities unnecessary.  The new program is still in the planning stages, but will involve the development and implementation of new methodologies.

This sounds like progress.  As this blog often has noted, nanotechnology assessment has received more attention in the international arena than in the United States, and this is another example of an international organization moving forward.

A summary of CoCAP may be accessed at:

 A report of the announcement to replace CoCAP appeared in

Rick Mitchell, Multi-Nation Group to Replace Program That Weighs High-Volume Chemical Hazards, 28 Toxics L. Rep. (BNA) 707 (June 27, 2013) (by subscription)

Speaking of the EU, the European Commission is seeking suggestions on better applying the REACH assessment to nanomaterials.  The official document seeking comments states:

“Specifically, the policy initiative shall provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with the aims of REACH Article 1(1) ‘to ensure a high level of protection of   human health and the environment, including the promotion of alternative methods for assessment of hazards of substance, as well as the free circulation of substances on theinternal market while enhancing competitiveness and innovation’.”

The Commission is reaching out to all interested stakeholders to provide “the best possible evidence base for its work.”

The official announcement, with information on submitting comments, is available at:

In another demonstration of international cooperation, the United States and Canada have developed a uniform classification system for industrial nanomaterials.  The U.S.-Canada Regulatory Cooperation Council’s (RCC) working group has been involved in this process since 2011 as part of a broader initiative to bring about uniformity in addressing nanotechnology.  This latest step is part of a continuing process.  This blog has previously discussed the work of the RCC here.

Here in the United States, EPA has issued its final significant new use rules (SNURs) for 17 substances, mostly constituting substances at the nanoscale, which will go into effect on August 26, 2013.  Fifteen of the seventeen SNURs are based upon TSCA section 5(e) consent orders issued by EPA and reflect the substance of the orders.  With regard to the other two SNURs, “EPA determined that one or more of the criteria of concern . . . were met.”  (Final Rule, p. 6)  In the Final Rule, EPA responded to various comments, including those directed at workplace safety.  This blog will address those comments at a later date.

The Final Rule is available at:

nano 3The National Nanotechnology Initiative (NNI) recently held a Stakeholder Workshop for the purpose of assessing and strategizing in anticipation of the next version of the NNI Strategic Plan, a draft of which is due in late 2013 or early 2014.  Stakeholders from industry, government, and academia attended the workshop.  Participants considered questions related to technical challenges; commercial nanotechnology; environmental, health, and safety considerations; infrastructure needs; and ethical, legal, and societal implications of nanotechnology.

On the subject of environmental, health, and safety considerations, one report from the workshop indicated that NIOSH officials have recommended folding these matters into the other goals, rather than maintaining a separate approach.  The officials noted that of the $1.65 billion in federal funding allocated in FY2013 for nanotechnology research and development, environmental, health, and safety initiatives constituted only 7.6% of those funds.

Some of the other issues addressed, according to the report were:

1.  Improving communication among researchers.

2.  Balancing availability of research with confidentiality of proprietary information.

3.  Developing a common dose metric for research.

This news report may be found by subscription at:

Robert Iafolla, Include Safety, Environmental Concerns in Strategic Plan, Nano Researcher Say, 115 BNA Daily Env’t Rep. A-8 (June 14, 2013), available at


Whatever steps may be necessary to ensure that environmental, health, and safety concerns are at the forefront of the discussion about nanotechnology should be made a priority.


A detailed presentation of the Questions for Stakeholders for discussion at the 2013 NNI Strategic Planning Stakeholder Workshop, with further links, may be found at:

Lab beakerOne of the hallmarks of scientific knowledge is the ability of researchers to replicate results.  This has eluded scientists studying the health effects of exposure to nanomaterials for a variety of reasons.  Among the factors are:  the unavailability of standardized engineered nanomaterials for testing; differences among the many manufacturers of nanomaterials; lack of standard protocols; and variations in toxicity among particles due to the way the particles behave in certain situations. 

To attempt to resolve these problems, dozens of researchers from universities and NIOSH participated in what has been called the NanGo Consortium to conduct health studies on engineered nanomaterials using the same materials and developing standard protocols.  The program was developed by the National Institute of Environmental Health Sciences (NIEHS).

The inter-laboratory, multi-investigator Consortium defined some of the challenges it faced as follows:

“In addition to dose, there are multiple factors that influence the toxicity of ENMs, including surface characteristics, charge, and shape. Size alone is a major determinant as many bulk materials that are relatively inert become toxic when produced at the nanoscale. . . . Determination of which ENMs will present the greatest potential threat to human health depends on relative toxicity, and on the potential for exposure.”  (pp. 5-6)

The Consortium conducted two broad sets of studies.  The first involved rats and mice exposed to carbon nanotubes and titanium dioxide, and measured pulmonary inflammation.  The Consortium concluded:  “The results presented and discussed herein demonstrate that a standard protocol can be used across multiple laboratories to yield similar results in the pulmonary inflammatory response.” (pp. 6-7)  The researchers are optimistic that with this start, there will be opportunities to determine the impact that exposure to nanomaterials may have on human at the preventive stage.

The second study examined the effects of carbon nanotubes, titanium dioxide, and zinc oxide in vitro in laboratory container studies.  The Consortium noted:  “A significant finding of this study was that the development of harmonized in vitro assay protocols made it possible to achieve reproducible results among different laboratories.” (p. 16)  This study, the Consortium concluded, “provides new information on the relative in vitro bioactivity of a large group of diverse ENM that can be used to inform future strategies for in vitro testing and predicting in vivo outcomes.” (p. 6)

These studies move researchers in the direction of being able to replicate results and ultimately draw reliable conclusions about the potential health hazards of exposure to nanomaterials, leading to effective regulation.

The NIEHS NanoGo Consortium reports are available at


The Canada-U.S. Regulatory Cooperation Council (RCC) has announced a pilot program to examine the differences between risk assessment practices for nanomaterials in both countries with the goal of identifying and sharing the best practices.  The RCC was initiated in 2011 by President Obama and Prime Minister Harper to coordinate the risk assessment practices of the two countries on a scale broader than nanotechnology.  Within the RCC, the Nanotechnology Working Group has focused specifically on looking into the potential risks of nanomaterials.

The Nanotechnology Work Plan generated by the RCC Nanotechnology Working Group states the following as the desirable outcome of the Group’s efforts:

“Share information and develop common approaches [between the two countries], to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc.  Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.”

The stated purpose of the common approaches would be to “help ensure consistency for industry and consumers in both countries.”

The Working Group sees its ultimate task as the development of “a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture.”

All quite worthy goals.  But as with so many efforts to understand the potential health and environmental risks of nanomaterials, this effort has its pluses and minuses.

The best features of the RCC initiative are international governmental cooperation and sharing of expertise and experience.  But some of the same frustrations evident in the nanotechnology risk assessment and regulatory arena still exist.  For example, we are still looking at a protracted process of risk assessment, followed by a protracted process of developing regulations.  As part of that, the group must still agree upon a taxonomy and risk assessment goals and specific procedures.  And most certainly there will be fragmentation and duplication of efforts between North America and the rest of the world.

It’s still a good idea.  But let’s not expect too much too soon.

The Nanotechnology Work Plan is available at

Sometimes the Government  just might work as it was intended.

In an earlier post, I reported on a lawsuit brought by a coalition of environmental and consumer safety groups requesting declaratory and injunctive relief under the Administrative Procedure Act to force the FDA to respond to a 2006 petition seeking action by the agency to assure the safety of members of the public exposed to nanomaterials, particularly nanoparticles in sunscreens.  On May 14, 2012, the coalition voluntarily dismissed its action, International Center for Technology Assessment v. Hamburg, a case that had been brought in federal court for the Northern District of California (No. 11-6592).

In other posts on this blog, I have reported on the draft guidances recently issued by the FDA on the safety of nanomaterials in food, food packaging, and cosmetics, as well as the upcoming International Cooperation on Cosmetics Regulation (ICCR), to be hosted by the FDA.  The coalition has withdrawn its lawsuit because the FDA has in fact finally responded to the earlier petition by issuing the draft guidances.  Although attorneys for the coalition have emphasized that the FDA’s response does not propose all the relief the coalition sought in its lawsuit, at the present time the FDA is showing interest in the safety of engineered nanomaterials in products within the agency’s jurisdiction.  The lawsuit had sought, among other things, regulation of these nanomaterials.  But the FDA guidance documents made recommendations for voluntary measures by industry, not new regulation.  This, of course, leaves open the possibility of a future lawsuit challenging the steps taken – or not taken – by the FDA in furtherance of the safety initiatives.

Our high school civics classes teach us that the tripartite structure of the federal Government is intended to allow the various parts of the Government to act as a check on the actions or inactions of the other parts.  In recent years, the judicial system has been much maligned.  In the matter of nanomaterials and the FDA, the threat of judicial intervention – being told by the courts what it should do – was likely one (and only one) motivation for the FDA to pursue a safety agenda for nanomaterials.  Instead of needlessly consuming resources at this stage, the coalition withdrew its lawsuit when the FDA moved forward on this subject.  So let’s give a hand all around for the Government working as it was intended.

The withdrawal of the coalition’s lawsuit was reported by

Pat Rizzuto, Coalition Withdraws Lawsuit Against FDA Following Agency’s Release of Guidance, 100 Daily Env’t Rep. (BNA) A-15 (May 24, 2012) (by subscription)

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.