Category: Environment

Regulatory Confusion and the Need for Consistency

Posted Dec.15, 2011 under Chemicals, Environment, EPA, Government Agencies, Governmental Interaction, Health, International Nanoregulation, Regulation, Safety

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)

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The Bigger Picture: Thinking About Technology, Nano and Otherwise

Posted Sep.25, 2011 under Environment, Evidence, Government Agencies, Litigation, Products Liability, Supreme Court, Toxic Torts
usalawyerstoday.com

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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.

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Proposed Disease Cluster Legislation: What’s Nanotechnology Got to Do With It?

Posted Jun.26, 2011 under Environment, EPA, Government Agencies, Governmental Interaction, Health, Regulation, Safety, Toxic Torts

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

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White House Takes a Science-Based Approach to the Study and Regulation of Nanotechnology

Posted Jun.15, 2011 under Cosmetics, Drugs, Environment, EPA, FDA, Food, Government Agencies, Governmental Interaction, Health, Pesticides, Regulation, Safety, Statutes, Workplace

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

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Dipping Into the Regulatory Alphabet Soup Once Again: A Dilemma

Posted Jun.07, 2011 under Chemicals, Cosmetics, Drugs, Environment, EPA, Health, International Nanoregulation, Pesticides, Regulation, Safety, Statutes, Workplace
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.

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What’s New in Nanogovernance? A Brief View from All Sectors

Posted May.29, 2011 under Chemicals, Cosmetics, Environment, EPA, European Union, Government Agencies, Governmental Interaction, Health, Nanosilver, Pesticides, Regulation, Safety
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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

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Thoughts on War Dust and Nanoparticles

Posted May.20, 2011 under Environment, Government Agencies, Health, Regulation, Research, Safety

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

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

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

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

 

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

http://www.usatoday.com/news/military/2011-05-11-Iraq-Afghanistan-dust-soldiers-illnesses_n.htm

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Balancing Innovation and Oversight – A Tall Order

Posted Apr.27, 2011 under Environment, EPA, Government Agencies, Governmental Interaction, Health, Regulation, Research, Safety

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

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

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

●  Scientific Integrity

            ○  Use of best available scientific evidence

            ○  New information should be developed and taken into account

●  Public Participation

            ○  Promoting accountability

●  Communication

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

●  Benefits and costs

●  Flexibility

○  To accommodate new information regarding the technologies and their applications

●  Risk assessment and risk management

            ○  Goal of consistency across agencies and across technologies

●  Coordination

            ○  Among agencies, with state authorities, and with stakeholders

●  International cooperation

●  Approach to Regulation

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

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

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

 

The memorandum is available at

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies.pdf

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Thinking Again about Nanoparticles and Asbestos

Posted Mar.29, 2011 under Asbestos, Environment, EPA, Governmental Interaction, Health, Litigation, Nanotubes, Products Liability, Regulation, Research, Safety, Toxic Torts, Workplace

asbestos-fibreEarlier, I wrote about some potential similarities between asbestos personal injury litigation and the litigation that is certain to come over nanoparticles and human health.  I will be writing on and off about this topic going forward as well.  I can’t emphasize enough the urgency of avoiding another disaster like asbestos litigation, which has clogged the courts since the 1970s.

For example, engineered nanomaterials are being placed into building materials.  In the first instance, these materials are being designed and manufactured in the primary workplace environment, thus potentially exposing workers to hazards about which little or nothing is known.  Another set of workers, those using the building materials in the secondary workplace, run the risk of exposure to potentially harmful substances.

The history of asbestos shows that the early studies were conducted on asbestos textile factory workers, but that meaningful studies on workers out in the field who were installing the materials lagged far behind.  Then, when the studies began to raise danger signals, the industry ignored those signals until the specter of mass litigation and government regulation forced recognition.  By then it was too late.

Nanomaterials present some of the same workplace issues, particularly when used in building materials.  The hazards of the primary workplace may be different from those in the secondary workplace.  Studies must be conducted on both types of environments.

Further, there is a third concern, which also mirrors the asbestos experience.  At some point down the line (years or decades), the anticipated life of the materials will expire, just as asbestos insulation materials have done.  At that point, degeneration of the materials could put nanomaterials into the environment to a degree that could endanger the safety of persons in the vicinity.

In the case of nanomaterials, do we know any of this for certain?  No.  But at the present time we know almost nothing about any of these safety issues.  In December, the National Institute for Occupational Safety and Health (NIOSH) proposed a workplace exposure limit for carbon nanotubes and nanofibers.  This is a start; but without hard data, it is really only a guess.  And it is not necessarily consistent with limits for other substances.

While the industries creating and using nanomaterials will likely take seriously the lessons of asbestos, more should be done up front to ascertain the seriousness and scope of the hazards that the materials may present.  Now is the time.  If the hazards outrun the studies, the finish line will be litigation.

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Daubertizing Nanolitigation – Part 3

Posted Mar.01, 2011 under Chemicals, Cosmetics, Environment, Evidence, Health, Litigation, Pesticides, Products Liability, Research, Safety, Toxic Torts

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).

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