Category: Regulation

Judicial Nano Standards?

Posted May.27, 2010 under Environment, Governmental Interaction, Litigation, Nanotoxicology, Regulation, Safety, Statutes
usalawyerstoday.com

usalawyerstoday.com

It is safe to say that the current state of nanotech litigation is embryonic.  There are only a handful of cases dealing with the validity of rules governing nanomaterials, and the results are
resoundingly similar – deference to the rule maker.  In Kennecott Greens Creek Mining Co. v. Mine Safety and Health Admin., 476 F.3d 94, 946 (D.C. Cir. 2007) (a three year old case that accurately represents the issue in the few cases brought before the courts), judicial review was sought regarding three regulations promulgated by MSHA. Specifically, the rules were implemented to require mining operations to utilize new engines that reduced the emission of diesel particulate matter, but it was argued that those same engines produced high levels of nanoparticle emissions  in the process.  On appeal, the court disagreed with the mine owners and took a complete deferential approach because the risks associated with nanoparticles, at this point, are speculative at best until further developments.

We should expect to see similar types of cases with the same results for some time or until there is solid proof of a substantial problem.

In June 2009, the EPA Nanomaterial Research Strategy released a list of eight questions that need to be considered to determine the risks involved with nanotechnology and quite possibly could become the nexus for non-deferential judicial opinions in the future.  Kristine L. Roberts, Nanotechnology and the Future of Litigation, LITIGATION NEWS,
Winter 2010, at 6, 8.  The list on page eight includes the following inquiries:

1) What advances in technology must occur to detect and quantify nanomaterials in the environment and biological material?
2) What are the major environmental impacts?
3) What are the exposure risks?
4) What are the effects on our health?
5) What are the ecological effects?
6) How many risk assessment approaches need to be amended/created?
7) Which nanomaterials have a high potential for release?
8)Can manufactured nanomaterials be utilized in a sustainable manner?

This list, at first glance, seems like a blunt tool when compared to the enormity of what it is attempting to procure.  However, this is one of the first proactive steps with regard to whom is going to be accountable for what in future ligation involving nanotechnology – litigation that should include more applicable standards based on
concrete information instead of automatic deference due to lack of knowledge.

1 Comment

Report of the President’s Cancer Panel – What’s Nano Got To Do With It?

Posted May.07, 2010 under Environment, Governmental Interaction, Health, Regulation, Research, Safety

prod liab imageRecently, the President’s Cancer Panel released its report, “Reducing Environmental Cancer Risk: What We Can Do Now,” which made the bold and distressing statement that “the true burden of environmentally induced cancer has been grossly underestimated.”  Currently, there are approximately 80,000 chemicals on the market in the United States many of which are likely carcinogens that are used by most Americans on a regular basis in their daily lives.  The risks of these carcinogenic substances have a significantly greater impact on children than adults.  The Panel observed that most of these chemicals are “un- or understudied and largely unregulated.”  Among other things, the Panel concluded that research on the environmental causes of cancer has taken a back seat to research on the genetic and molecular mechanisms that cause cancer.  Research into the environmental causes of cancer has been given low priority and insufficient funding, they say.

 What does this report on chemicals and cancer have to do with nanotechnology?  The long-term health risks of nanotechnology are currently unknown.  If, as the Panel states, only a few hundred of those existing 80,000 chemicals have been tested for safety to date, where does that put emerging technologies such as nanotechnology?  Right now, at the bottom of the list.  And if the Panel’s recommendations are implemented, it is likely that available resources will be consumed by studying a fraction of those 80,000 chemicals.

 The Panel identified the following barriers to effective regulation of environmental contaminants:

 “(1) inadequate funding and insufficient staffing,

(2)   fragmented and overlapping authorities coupled with uneven and decentralized enforcement,

(3)   excessive regulatory complexity,

(4)   weak laws and regulations, and

(5)   undue industry influence.”

 It is worth considering the degree to which each one of these barriers to effective regulation may apply to nanotechnology, either now or in the coming months and years.

 Given this state of affairs, what is to be done?  One might reasonably ask:  Why should the public bear the burden of proving that an environmental exposure is harmful?  Would it make more sense to have industry – those developing the substances and placing them on the market – conduct the studies on the human environmental impacts in the first instance?  When it comes to consumer products, it seems that it is only after the fact – after harm has come to persons exposed – that the requisite depth of study is conducted.

 This is an ongoing discussion.  I will be examining other aspects of the Panel’s report in relation to nanotechnology in future posts.

 The report may be found at

 http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_08-09_508.pdf

1 Comment

Nanotechnology and Government Alphabet Soup

Posted May.01, 2010 under Environment, Governmental Interaction, Health, Regulation, Safety, Statutes
www.inoxpa.com

www.inoxpa.com

As I’m reading some material on the federal National Nanotechnology Initiative (NNI) web site, I am struck by the breathtakingly broad scope of nanotechnology and its incorporation into useful products that reach into every facet of life.  The NNI coordinates funding for nanotechnology R & D across 25 federal departments and agencies.  NNI promotes the development and use of the technologies through NNCO (the National Nanotechnology Coordination Office) and the NSET Subcommittee (the Nanoscale Science, Engineering, and Technology Subcommittee), and of course those 25 federal departments and agencies.  NNI also is involved in coordinating research strategies for studying the effects of nanotechnology on the environment and on the public’s health and safety.  But so far it has not taken any specific position on regulation.

 

To demonstrate what regulation could look like, it’s useful to think about the many departments, agencies, and federal acts or regulatory measures that could come within the jurisdictional scope of nanotechnology and nanosubstances.  To name just a few:

 

Department of Agriculture

Department of Labor

Department of Homeland Security

Department of the Interior

Health and Human Services

Department of Energy

Etc.

 

FDA (Food and Drug Administration)

FDCA (Food, Drug, and Cosmetic Act)

EPA (Environmental Protection Agency)

CWA (Clean Water Act)

CAA (Clean Air Act)

OSHA (Occupational Safety and Health Administration)

PEL (Permissible Exposure Limits)

NIOSH (National Institute of Occupational Safety and Health)

NSF (National Science Foundation)

FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act)

NEPA (National Environmental Protection Act)

TSCA  (Toxic Substances Control Act)

CPSC (Consumer Product Safety Commission)

FHSA (Federal Hazardous Substances Act)

SDWA (Safe Drinking Water Act)

To name only a few . . .

 

The point of this alphabet soup exercise is that nanotechnology impacts so many facets of society that developing an approach to regulation will be difficult at best.  Leaving regulation to individual agencies will by its nature be narrow, thereby missing many issues.  But broad regulation – such as a new department along the lines of Homeland Security – may lack coherence and control.  As nanoproducts proliferate and nanotechnology becomes more pervasive, regulation will come, and it must strike a balance between these two poles.

1 Comment

What Do the Studies Mean?

Posted Apr.22, 2010 under Cosmetics, Health, Litigation, Nanotoxicology, Products Liability, Regulation, Research, Toxic Torts
www.h20technologies.com

www.h20technologies.com

In the call for studies on the health and safety of nanoparticles in various uses, it is easy to overlook important questions about what the studies mean.  Does a study demonstrating what may be considered an adverse outcome provide a basis for legal action?  The complex answer is, “Sometimes yes and sometimes no,” or in the words of every law professor, “It depends.”

Let’s take a look a highly publicized study published in late 2009.  See Trouiller et al., Titanium Dioxide Nanoparticles Induce DNA Damage and Genetic Instability In vivo in Mice, CANCER RES. 2009; 69: (22), Nov. 15, 2009.  Researchers from UCLA conducted a study in vivo on mice to test the effects of the titanium dioxide nanoparticles, regularly used in many consumer products, including cosmetics (especially sunblocks), food coloring, toothpaste, and paint.  The researchers herald their study as the first in vivo study to demonstrate a connection between the particular substance and genetic harm.  Previous in vitro studies, they say, produced mixed results and by their very nature did not involve living tissue.

First, a word about how the law views in vitro and in vivo studies.  In vitro studies, such as the Ames test, test the effects of chemicals on bacteria or other cells in a laboratory dish, looking for genetic mutations.  These studies are sometimes offered in a legal setting to suggest that exposure to the substance is carcinogenic in human, on the theory that somatic cell mutations lead to uncontrolled cell reproduction and, ultimately, cancer.  In vivo studies compare laboratory animals exposed to a particular substance to a control group that was not exposed, looking for differences in outcomes between the two groups.  What both types of studies have in common is that they do not involve humans.  As a result, they also have in common the need to extrapolate from the test data to predictable results in humans, a process that is speculative.  In other words, both studies fall short of demonstrating exactly what will happen when humans are exposed to the substance.  But both are relatively fast, inexpensive, and do not involve the ethical dilemmas of testing on humans.

Courts bristle when plaintiffs seek to introduce this kind of evidence, without anything else, in personal injury litigation as proof that exposure to a particular substance caused their illnesses.  The role of courts in determining what evidence is admissible under the rules of evidence is designed to keep frivolous suits from consuming resources and from reaching juries, which might be more impressionable than the court.  Regulators are less constrained than courts, however.  The role of government regulators is circumscribed by the legislation giving them authority.

In the scheme of things, the law prefers in vivo studies to in vitro studies because in vivo studies demonstrate some action of the substance on mammalian living tissue.  But both types of studies are a distant second to epidemiological studies on human populations.  Such statistical studies of risk factors examine groups of humans to determine the strength of relationships between exposures and outcomes.  But even they do not examine the direct impact of the substance on human tissues.

All scientific and statistical studies used to demonstrate carcinogenicity serve to demonstrate the difficulty the law has with understanding and using the studies to make legal decisions.  In the important U.S. Supreme Court case of Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), in which the Court provided guidance on determining the reliability of scientific studies in the federal courts (in the context of a toxic torts case involving the prescription drug Bendectin), the Court had the following to say about the distinctions between science and litigation:

[T]here are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly. The scientific project is advanced by broad and wide-ranging consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably wrong are of little use, however, in the project of reaching a quick, final, and binding legal judgment – often of great consequence – about a particular set of events in the past.

Id. at 596-97.

There is strength in numbers, however.  The more reliable studies that are conducted showing similar results, the more likely the substance will be regulated effectively.  And the more likely litigants will be able to assemble a package of expert scientific evidence that will support their positions.

 

An abstract of the article may be found at http://cancerres.aacrjournals.org/cgi/content/abstract/69/22/8784

4 Comments

Nanotechnology in Our Food

Posted Apr.18, 2010 under Artificial Molecular Machines, Governmental Interaction, Health, Litigation, Nanotoxicology, Products Liability, Regulation, Toxic Torts
www.inoxpa.com

www.inoxpa.com

According to a recent report from the United States Government Accountability Office (GAO), the FDA is currently taking a hands-off approach to food additives that contain engineered nanoparticles.  In fact, the FDA does not require food manufacturers to report additives that are deemed generally regarded as safe (GRAS).  Who determines the GRAS status?  The food manufacturers, without oversight or approval from the FDA!  The following excerpt from the GAO report, United States Government Accountability Office, Report to Congressional Requesters, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS) (2010), provides a realistic and chilling view at the current intersection of the American food supply and nanotechnology:

FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. While some uses of engineered nanomaterials have the potential to help ensure food safety, uncertainties remain about how to determine their safety in food. After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

Id. at Highlights page (emphasis added).

The application of nanotechnology to food is potentially very beneficial. Two specific examples are 1) nanotags to “improve the traceability of food products (the ability to track these products from point of origin to retail sale)” and 2) the most prolific “usage appears to be in food packaging, where applications such as antimicrobial nanofilms—thin layers of substances meant to hamper the growth of bacteria and fungi—may help bolster food safety.” Notwithstanding the current and obvious benefits, the FDA, and its foreign counterparts, realized that the potential for hidden challenges does exist.  As a result, the FDA created a taskforce in 2007 to identify some of the potential pitfalls, and to recommend possible solutions. The taskforce identified several challenges posed by utilizing nanotechnology, specifically “ensuring the adequacy of methods for evaluating the safety of these engineered nanomaterials in food.” It also made mention of how little the FDA actually knows about nanotechnology and as a result, declined to include a definition of it in its report. (GAO Report 26-27).

At this point in time, even if something were to go awry as a result of nanomaterials being utilized in the food supply, where does the blame fall? According to current administrative law, the courts take an extremely deferential stance in favor of agency decisions when it comes to science. In Baltimore Gas & Elec. Co. v. Natural Res. Def. Counsel, 462 U.S. 87, 103 (1983), the Court stated, “[a] reviewing court must remember that the [agency] is making predictions, within its area of special expertise, at the frontiers of science. When examining this kind of scientific determination, . . . , a reviewing court must generally be at its most deferential.” This case dealt with a rule adopted by the Nuclear Regulatory Commission (NRC) based on findings “that permanent storage of nuclear waste would have no significant environmental impact.” Michael Asimov & Ronald M. Levin, State and Federal Administrative Law 595 (3d ed. 2009). This leads one to believe that if the NRC received this level of deference in the early stages of nuclear energy proliferation, the courts would almost certainly provide the same to the FDA’s lackadaisical decision-making approach to nanotech and the food we eat.

I certainly do not wish to suggest that the use of nanomaterials in our food supply is going to lead us down the long road of massive tort litigation, but I do wish to assert that if we are not vigilant from the very beginning, it is anyone’s guess where it could lead.

www.gao.gov/new.items/d10246.pdf

www.foodsafetynews.com/2010/03/gao-fda-does-not-ensure-safety-of-food-additives/

1 Comment

Initial Thoughts on Regulation

Posted Apr.09, 2010 under Environment, Governmental Interaction, Health, Regulation, Toxic Torts
www.h20technologies.com

www.h20technologies.com

We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks.  The law has yet to develop in this field.  I am pleased to start the conversation in this blog on the legal issues that are beginning to emerge about nanotechnology.  My entries will focus on efforts to determine what risks the new technologies may pose to consumers and the population in general.  My expertise in the area of toxic tort law is uniquely suited to examining the emerging health concerns from the viewpoint of anticipated litigation.  My co-blogger, Eric Laury, Widener Law ’11, will focus on the legal issues involving the development and use of the technologies, including intellectual property matters.  This blog is not intended to be a news source, though it will provide some links to stories in the news that bear upon our commentary.  Rather, we intend to analyze and question the developments as they emerge, and to place them in a legal context that will be useful for attorneys, regulators, and other legal observers.  We hope that our observations will begin the discussion and debate over the legal ramifications of nanotechnology.

Every week, numerous developments are reported in the media, but I will give my attention here to just one of them.  On March 25, 2010, the President’s Council of Advisors on Science and Technology (P-CAST) issued its report on the Third Assessment of the National Nanotechnology Initiative.  Among many other things, P-CAST calls for “clear principles” for identifying the environmental, health, and safety risks of nanotechnology.  To implement this, the report recommends further development of the existing cross-agency strategic plan to link research activities and information sharing and suggests that “member agencies increase coordinated efforts to overcome barriers to effective, sustainable, and responsible commercialization of nanotechnology.”

This is vague, suitably so for the first steps toward regulation.  One might question, however, the laissez-faire approach that it supports.  To start the discussion on examining the risks of nanotechnology, it is worthwhile to consider how the Government might regulate the products of these technologies.  What would regulation of the health and environmental impacts of nanotechnology look like?  One possibility is the current P-CAST proposal – interagency exchange of information with an individual directing interagency coordination efforts.  Another model would be the creation of an umbrella agency to manage nanotechnology, including the health, environmental, and safety risks of products using the technology.  This concept would take all nanotechnology-related matters away from other agencies – which, presumably, have at least some experience with handling new technologies – and place them within the authority of the new agency.  Another model might be creating a Department of Science and Technology along the lines of the Department of Homeland Security, though determining which agencies – or which parts of which agencies – would fall within the authority of a new Department would be problematic.  Finally, we could leave well enough alone and let existing agencies regulate individual uses of nanotechnology as they arise.  Under this incremental approach, for example, the FDA could regulate medical uses of nanotechnology on a use-by-use basis.

We need to think now about regulating nanotechnology and about what structure that regulation should take.  The history of toxic tort litigation is strewn with products that were allowed on the market with little or no health and safety regulation.  The result was massive health risks, seemingly endless litigation, and studies done too long after the fact.  Just consider the course of asbestos litigation.

www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf

2 Comments