Category: Chemicals

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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:

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.

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.

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.

On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation.”  Speakers came from all sectors, including private law firms and industry.

Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.

1.  Size.  It really is all about size.  Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation.  Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.

2.  Progress.  Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology.  There is a pervasive concern about the prevalence of these technologies and the paucity of studies.

3.  Fragmentation.  Attention to the potential issues raised by nanotechnology continues to be highly fragmented.  There has been intensely focused attention to some issues, but others remain to be addressed.

For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products.  Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.”  Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials.  Other applications are pending for registration of pesticides containing nanomaterials.  EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product.  Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide.  But risks assessment lags behind.  According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”

Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar).  But progress in one area does not necessarily mean progress elsewhere.  The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches.  And standardization remains a debatable issue in itself.

4.  Industry Uncertainty.  Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful.  The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.

5.  Bottom Line.  The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.

Other speakers at the webinar included representatives of:

Nanotechnologies Industries Association, Brussels, Belgium

Chemical Control Division, Office of Pollution Prevention and Toxics, EPA

U.S. Consumer Product Safety Commission

California Nanotechnology Initiative

California Department of Toxic Substances Control

Environmental Defense Fund, Inc.

. . . and several attorneys in private practice

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.