Category: Safety

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 http://www.nas.edu/catalog.php?record_id=13347

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

http://dels.nas.edu/Study-In-Progress/Research-Strategy-Environmental-Health/BEST-K-08-01-A#

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

http://www8.nationalacademies.org/cp/projectview.aspx?key=49409

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

www.nytimes.com/2012/01/13/science/smaller-magnetic-materials-push-boundaries-of-nanotechnology.html?_r=1&scp=1&sq=nanomaterials&st=c

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

http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf

The 2007 Nanotechnology Task Force report is available at

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

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

http://www.nist.gov/mml/polymers/cnt-122011.cfm

The Standard Reference Material is available at

https://www-s.nist.gov/srmors/view_detail.cfm?srm=2483

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

ec.europa.eu/environment/chemicals/nanotech/pdf.commission_recommendation.pdf

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

ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-EASAC-report.pdf

 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.

capitol_building_

In January, a bill was introduced in Congress proposing an act to assist governments on all levels to investigate disease clusters.  The short title is the “Strengthening Protections for Children and Communities From Disease Clusters Act,” and is referred to as the Disease Clusters Act.  Disease clusters are generally defined as “the occurrence of a greater-than-expected number of cases of a particular disease within a group of individuals, a geographical area, or a period of time.”  Sec. 5(4)(A).  Because children are more susceptible than adults to the risks of environmental pollutants and toxic substances – due to a variety of developmental and environmental factors – the act proposes to facilitate investigation of disease clusters and the potential hazardous substances that may cause those diseases.  The act would grant authority to EPA to develop regulations and to coordinate efforts and funding with states and communities.  Sec. 3 & 4.

Disease clusters are well known in toxic torts.  The existence of a disease cluster does not necessarily mean that a causal connection can be drawn between the disease and substances to which the population was exposed.  Recent examples have been breast cancer clusters in Long Island and autism clusters in New Jersey or among children who have received certain vaccines.  While it is possible that environmental or product-related connections could yet be discovered, to date reliable science has not been able to make those connections.  In contrast, in Woburn, Massachusetts, in the 1980s, citizens discovered a cluster of childhood leukemia.  Grass roots investigation, followed by an epidemiological study performed by Harvard University, demonstrated a connection between chemicals in the drinking water supply of two of the wells that supplied the part of town where the ill children lived.  The story of this community and the subsequent litigation have been described in Jonathan Harr’s book, “A Civil Action,” and the movie adaptation.

As the Woburn example demonstrates, it is important to investigate disease clusters.  But it is equally important to recognize that sometimes a disease cluster is coincidental.  The proposed legislation would treat all disease clusters alike in the initial phases of investigation, using the best available science.  And some might criticize an outlay of resources for an uncertain enterprise.

Where does nanotechnology enter this picture?  The act makes no mention of any specific potential hazards, though it does reference environmental pollutants and toxic substances and indicates that the substances may be present in the air, water, ground, drinking water supply, waste sites, and any other place, whether or not already regulated by another statute.  Sec. 5(7).  Nanomaterials in the environment would fall within the definitions in the act.  The act would be a way to examine the health and environmental effects of nanotechnology that may not be captured – or yet captured – under existing regulatory schemes.

The down side, however, is that citizens shouldn’t have to wait until disease clusters manifest for potential hazards to be studied.  Diseases such as cancer caused by exposures to toxic substances generally manifest symptoms after a latency period that could be as long as several years.  The same is true of developmental delays in children.  It is always preferable to prevent the problem in the first instance.  But the law recognizes that that is not always possible.  This disease cluster act would be a post hoc solution, after some people have already become ill.  But it could prevent others from suffering the same fate.

The bill is sponsored by Senators Barbara Boxer and Mike Crapo.  It was referred to the Committee on the Environment and Public Works, which favorably and without amendment reported it to Congress on June 9, 2011.

 The bill may be read in its entirety at

http://www.govtrack.us/congress/billtext.xpd?bill=s112-76

white-house-south-2007-djIn a June 9, 2011, memorandum to the heads of U.S. executive departments and agencies, entitled Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, the White House confirmed its commitment to a “science-based” approach to health and safety matters related to nanotechnology.  The memorandum issued from the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the U.S. Trade Representative. The memorandum described its approach as

“generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation.”

The memorandum went on to explain that the approach it establishes is inherent in the risk-based approach commonly used by federal agencies such as the FDA, but is grounded in best available, and evolving, science.

 This is a tall order.  It is important that the White House explicitly addressed nanotechnology and nanomaterials, rather than using the vague term “emerging technologies,” as it has done in the past.  But perhaps the most significant part of the memorandum is in its elevation of the science-based approach over other possible approaches (technology-based, economics-based, etc.) to the study and regulation of nanomaterials.

 Intending to provide guidance to existing federal agencies, the memorandum stated:  “Federal agencies should avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.”  Consumer trust, the memorandum went on to say, is important in encouraging technological innovation.

 On the one hand, the memorandum eased industry concerns that nanotechnology will be viewed as “bad” and all nanomaterials as “hazardous” because of the flurry of attention focused on the technologies and the concerns voiced by various groups.  But on the other hand, the message is clear that science will govern the study of nanomaterials and any decisions about whether or how to regulate.  And that is also a message to industry to come forward with the science that the agencies need.

 The memorandum also announced the creation of an interagency working group to coordinate this basic framework across agency lines, promote coordination of regulatory activities, and share information.

 How is this policy likely to play out in the relevant departments and agencies?  Here are a couple of recent steps that illustrate the initial approach:

 ●  On June 10, 2011, the FDA issued a Draft Guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, to provide manufacturers, suppliers, importers, and other stakeholders with the FDA’s “current thinking” on the subject.  The Draft Guidance was issued in conjunction with the White House memorandum.  The document provided no definitions, nor did it provide any information on the regulatory status of any products.  Rather, the document stated that its purpose is “to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nano-technology in FDA-regulated products.”

 The FDA Draft Guidance is available at

http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

 ●  A similar document was issued by EPA setting forth its proposed policy for obtaining data on nanoscale materials in pesticides, pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Another important aspect of what EPA is considering is a case-by-case analysis of whether a nanoscale ingredient in a pesticide is considered “new” for the purpose of study and regulation.  This is a sharp departure from EPA’s earlier stance that it would consider all nanoscale ingredients as “new,” whether or not a non-nanoscale form of the ingredient was already registered under FIFRA.  The new approach is consistent with the urging of the White House memorandum that agencies avoid generalizations about nanomaterials and based all decision on the scientific evidence.

 The prepublication version of this notice is available at

http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf

 

The White House memo is available at

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

prod liab imageListening to the speakers at the American Bar Association section webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation,” discussed in a recent blog post, I was struck by the proliferation of “alphabet soup” agencies and programs involved in deciding whether and how to regulate nanomaterials in the workplace, consumer products, and the environment.  The short list includes such well-known acronyms as FDA, EPA, OSHA, NIOSH, CPSC, NNI, TSCA, FIFRA, FHSA, REACH, and ISO (International Organization for Standardization), as well as many lesser known acronyms, such as SNUR (Significant New Use Rule), PPPA (Poison Prevention Packaging Act of 1970), CPSIA (Consumer Product Safety Improvement Act), OCSPP (EPA’s Office of Chemical Safety and Pollution Prevention), NMSP (Nanoscale Materials Stewardship Program), NICNAS (Australian National Industrial Chemicals Notification and Assessment Scheme), WPMN (international Working Party on Manufactured Nanomaterials), and many similar legislation and agencies on the state level.

The good news is that nanotechnology is receiving much attention across the board from regulatory agencies.  The less good news is that the work of determining the health and safety effects of nanomaterials on humans and the environment, including ecological systems, is fragmented and slow.

The U.S. federal government, by necessity, is comprised of a web of agencies and programs, each with many jobs.  With so much work to be done, smaller and smaller groups are focusing on specific research and problem solving initiatives.  As the federal government is accustomed to doing in many areas of concern, efforts to coordinate agencies and programs devoting a fraction of their time to nanotechnology health and safety issues are being utilized.  One clearinghouse for the efforts across the government is the National Nanotechnology Initiative (NNI).  Is that enough to prevent duplication of effort and resources and to encourage communication and progress?

The dilemma is not new.  It is at the foundation of all complex systems.  To get something done, the groundwork must be laid by a highly focused group.  As recommendations move along the regulatory channels, eventually (maybe) the work results in action by way of regulations or new/amended statutes.  Greater oversight and decision making at the top of the regulatory pyramid may sound more efficient, but the careful groundwork could be lost and the democratic principles on which our regulatory system is based (including publication and public comment) could be diminished.