Category: Governmental Interaction

A Tale of Two Bills – Nudging Toward Nanoregulation

Posted Jul.27, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Products Liability, Regulation, Research, Safety, Statutes

prod liab imageIt’s fair to say that the United States has not yet tiptoed into the waters of regulating nanotechnology directly.  Rather, new efforts at regulation of chemicals and consumer products tend toward indirect regulation.  That is, these efforts would strengthen and expand existing federal regulation.  Two examples are recent bills introduced in the House of Representatives that would amend the Toxic Substances Control Act (TSCA) and the Food Drug and Cosmetic Act (FDCA) for substances and products that may or may not contain nanomaterials.  As discussed in a previous entry in this blog, placing nanomaterials under the same regulatory standards as non-nano substances is a subject that requires discussion on its own.

 Is the current trend toward indirect regulation a good idea?  It’s certainly easier and more efficient in the short run to promulgate broad regulations that encompass a variety of substances and uses, and to amend existing statutes.  And there is no doubt that these statutes needed updating to reflect scientific advancement and new risks.  But there is a danger that regulators – and the public – would be left with the impression that once these statutes have been updated, all substances are sufficiently regulated.  With the products of nanotechnology being so diverse, it is likely that many substances would slip through the cracks of the new legislation.

 Let’s look at the two recently introduced bills.  The Toxic Chemicals Safety Act of 2010 (H.R. 5820) would amend TSCA by requiring the chemical industry to provide EPA with minimum essential data on chemical characteristics, toxicity, exposure, and use, whereupon EPA would undertake an expedited process to reduce exposures to toxic substances in the population.  An important feature of the bill provides for public disclosure of non-confidential and otherwise non-exempt information.  The text of the bill may be found at

http://energycommerce.house.gov/documents/20100722/HR5820.pdf

The current text of TSCA is at 15 U.S.C. §§ 2601 et seq.

The other recently introduced bill is the Safe Cosmetics Act of 2010 (H.R. 5786), which contains provisions for protecting consumers from carcinogenic and other toxic ingredients in certain previously unregulated household products, such as perfumes, shaving creams, shampoos, and deodorants.  Like the proposed TSCA amendment, a major purpose of this bill is to update the existing FDCA and its regulations and to disclose the information regarding hazards to the public, in this case primarily through product labels.  Currently, the cosmetics industry is mostly self-regulated, and members of the industry have complained that this new bill lacks appropriate standards and would place an undue burden on the FDA.  Instead, the industry has proposed its own new requirements.

 H.R. 5786 also references nanoparticles, clearly indicating that nanotechnology was intended to be part of the amendment.  For example, Sec. 618(a)(5) requires that cosmetic manufacturers submit various information to the FDA, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.”  Sec. 618(e) goes on to authorize the Secretary of Health and Human Services to require that

 “(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.”

 The text of this bill may be found at

http://www.govtrack.us/congress/billtext.xpd?bill=h111-5786

 Both bills seem to be a step in the right direction.  But in the context of nanotechnology, complicated questions persist.  For example:

●  Would these updated statutes reach the products of nanotechnology as effectively as they would reach substances and products that have no nano-contents?

 ●  Because benign substances may behave differently at the nanolevel, would such regulation miss potential toxic effects?

●  What science would be behind the decisions to disclose toxicity?

●  Should nanotechnology be regulated separate from chemicals and consumer products?

● Which alternative makes the most sense?

 These and others are the questions that Congress and regulators – and all those who may be potentially exposed – need fully discussed in the coming months and years.

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Standardizing Nanodefinitions

Posted Jul.07, 2010 under Governmental Interaction, Nanobiotechnology, Nanotoxicology, Regulation, Safety, Statutes
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Wikimedia

Let’s face it:  Industry would just as soon be left alone.  But in this modern society, that’s simply not possible.  Government regulation is necessary to advance policy goals, which include the safety and health of the general public.  Industry recognizes this, of course, and wants to be able to undertake its activities knowing what the government requires (mandatory) and expects (voluntary) of it.  This is even more critical in the world of global commerce, where an industry may be subject to varying – and sometimes even contradictory – standards in different countries.  In the United States alone, separate state regulation of nanotechnology could lead to confusing and incompatible standards.

 Isn’t the nanotechnology industry entitled to a uniform set of definitions to be able to interpret and apply regulatory standards?

 This is the gist of an article that appeared recently in the BNA Daily Environment Report at

Pat Rizzuto & Bill Pritchard, Industry Developing Nanoengineered Goods Frustrated by Regulators’ Lack of Definitions, 93 Daily Envt. Rpt. (BNA) B-1 (May 17, 2010) (available by subscription)

In recent months, various bodies have been attempting to address this issue, but it is likely that nothing representing a consensus may emerge soon.  Yet, there may be some urgency to the task.  As reported in the article, one industry executive in a company developing electronics using nanomaterials said that regulatory certainty is necessary in determining whether to move its operations from the United States to China.  The article went on to discuss the efforts that many countries are making to develop standard definitions for nanomaterials.  This, of course, is only a precursor to regulation.  There is currently no agreement as to what the size of a particle means in the regulatory world and whether a workable definition should be based solely on size.

The International Organization for Standardization (ISO) hopes to have a set of definitions by the end of the year.  The article goes on to indicate that a coalition of businesses may become involved in developing standardized definitions.

 The European Commission’s Joint Research Commission (JRC) released a report July 2, 2010, emphasizing the need for a uniform definition of the term “nanomaterial” and providing “practical guidance for a definition for regulatory purposes.”  The report recommends the following criteria, suggesting that a definition:

  •  only concern particulate nanomaterials,
  •  be broadly applicable in EU legislation, and in line with other approaches worldwide,
  • use size as the only defining property.

European Commission, Joint Research Centre, Considerations on a Definition of Nanomaterial for Regulatory Purposes 5 (2010).

 The JRC report may be accessed at

 http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf

 Clearly, we have not yet arrived at the point of being able to speak the same nanolanguage around the world.  Every nanostep helps, however.  But time is of the essence.  And consensus is crucial.

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Should Nanotechnology Be Regulated by Chemical Regulations?

Posted Jun.30, 2010 under Governmental Interaction, Health, Nanotoxicology, Regulation, Research, Safety, Statutes
www.h20technologies.com

www.h20technologies.com

In the ongoing effort to determine how best to regulate nanotechnology, the first and easiest suggestion is to use existing laws and regulations that were developed for chemicals.  Some observers believe that the labyrinth of existing regulations (through FDA, EPA, OSHA, and other agencies) is sufficient to regulate nanotechnologies and nanomaterials that may pose hazards to workers or the public.  In a recent report issued by the Government Accountability Office (GAO), the GAO noted that the “use of nanomaterials in products is growing faster than our understanding of the risks these materials pose to human health and the environment” (p. 49)

 U.S. Gov’t Accountability Office, Nanotechnology:  Nanomaterials are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk (2010) (report to the Chair, Senate Committee on Env’t and Public Works), available at

http://www.gao.gov/new.items/d10549.pdf

 The GAO report indicated that EPA believes it has the authority and ability to regulate manufactured nanomaterials through existing federal statutes, i.e. Clean Air Act, Clean Water Act, RCRA, TSCA, and FIFRA, and that it has the authority to manage cleanups of releases of nanomaterials that may be endangering human health or the environment, pursuant to CERCLA.  EPA is currently attempting to work within the structure of these laws to address the potential hazards of nanomaterials, but the GAO report observes that there are significantly greater difficulties in addressing the potential hazards of nanotechnology than in addressing the hazards of conventional chemicals:

 ●  The hazards of nanomaterials vary with the size and shape of the particle.

 ●  Nanomaterials may be more reactive with other chemicals.

 ●  EPA officials say that “it is difficult to assess the risk of nanomaterials that are released into the environment because these materials are so varied and it is difficult to make generalizations about how they will behave once they are released.”  (p. 28)

 ●  Only a limited number of studies have been conducted to date on the hazards of nanomaterials, and existing studies on a nanomaterial constructed in one manner may not be relevant to the same nanomaterial constructed in a different manner.  In other words, “studies of similar nanomaterials may not be comparable.”  (p. 29)

 ●  Many nanomaterials have not yet been studied.

 ●  The scientific community does not currently possess all of the necessary tools, “such as models or measurement technologies” (p. 30), to even characterize or describe the nanomaterials properly, let alone fully understand how the nanoparticles behave.

 ●  Some federal environmental statutes are better suited than others to address the potential hazards of nanomaterials.

 This brief summary of the obstacles to effective analysis of the hazards of nanomaterials – and, accordingly, to effective regulation of nanomaterials – raises an important threshold question for the legal, scientific, and regulatory communities:

 Will effective regulation come from addressing nanomaterials within the existing statutory framework, which was designed for chemicals and other conventional materials?

 This question must be raised, addressed, and vigorously debated.  Right now, there is no clear answer to that important question.  If a new approach, separate from the approaches used for conventional chemicals, is more likely to result in effective regulation sooner, rather than later, then common sense may dictate going that route.  The debate should begin now, not after another decade has passed.

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Nanosteps

Posted Jun.13, 2010 under Governmental Interaction, Health, Nanotoxicology, Regulation, Research, Safety
www.singularityhub.com

www.singularityhub.com

Last week, the Organisation for Economic Co-operation and Development (OECD) issued its updated manual to support the safety testing of manufactured nanomaterials.  The OECD describes itself as follows:

 “ The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organization in which representatives of 31 industrialised countries in North America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonise policies, discuss issues of mutual concern, and work together to respond to international problems.”

 The United States is a member country of OECD.

 The Guidance Manual for the Testing of Manufactured Nanomaterials:  OECD’s Sponsorship Programme is a product of the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology of the OECD.

 One goal of the projects contributing to the manual was to determine whether test guidelines for the safety of traditional chemicals may be suitable for testing the safety of manufactured nanomaterials.  Researchers are particularly interested in the role that particle size and specific area may play in the resulting toxicity of the nanomaterials.

What strikes me here – and when reading other sources on the safety of nanomaterials – is the need to focus on particle size as a factor in determining the health and safety risks.  In some respects, this is reminiscent of asbestos research, in which the size, shape, and characteristics of the asbestos fibers, as well as the manner in which they are bonded to or contained in the product, define the health risks associated with asbestos exposure.  It took a half century of asbestos research to arrive at an understanding of the mechanisms by which the fibers cause illness, including malignancies, and other physiological changes that may not result in illness.

The hope for nanotechnology is that this discussion and investigation are taking place sooner, rather than later, and that there is a concerted effort internationally to coordinate and share research.  Although unregulated nanomaterials are in extensive use already, and many more uses of nanotechnology become available each day, it is worth recognizing the efforts being made to identify the risks at an early stage.

Perhaps the asbestos example taught us something after all.

The manual may be accessed at:

http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html

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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.

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The Exposure Chain

Posted May.19, 2010 under Environment, Governmental Interaction, Health, Nanobiotechnology, Research, Safety
www.singularityhub.com

www.singularityhub.com

 

 

 

The President’s Cancer Panel’s Report, referenced in my previous post, makes many important statements about cancer.  One summary statement stands out.  The PCP states:

“Single-gene inherited cancer syndromes are believed to account for less than 5 percent of malignancies in the United States.  An unknown percentage of cancers develop due to normal endogenous [internal] processes [such as aging]. . . . Other cancers develop as a result of exogenous [outside of the body] factors, some of which are controllable.”

Report, Sec. 1, at 1.  The PCP then goes on to point out that the existing studies of the relationship of environmental exposures to cancer are out of date, but that even newer studies cannot take into account the many synergistic effects of multiple exposures in the environment that could lead to cancer.

Part of this problem is due to the complex chain of exposures.  The PCP summarizes the chain as follows:

Use of chemicals or other substances in industry and agriculture:  exposure of workers

Dispersal of  contaminants through:

Soil

Air

Water

Consumer products

Entry of the contaminants into the human body through various routes, which may impact both somatic cells and germ cells (egg and sperm)

Occurrence of higher levels of toxic and hormone-disrupting substances in women, including maternal blood, placental tissue, and breast milk

Transference of the substances from the mother to the next generation can occur to the fetus in utero or to a breast-feeding infant

Because the substances may interfere with the genes of the parents, without directly causing disease in the parents, these genes may predispose future generations to cancer.  This transference of the propensity to cause cancer may go from the parents’ genes to the next generation and beyond.

 In one of only a few references to nanotechnology in the Report, the PCP said:  “Limited research to date on unintended health effects of nanomarterials, for example, suggests that unanticipated environmental hazards may emerge from the push for progress.”  Report, Exec. Summary, at iii.

Where does nanotechnology fit into the chain?  At least theoretically, at every stage.  But nanotechnology is a complicating factor in an already complex scientific task.  As a kind of facilitating system – or delivery system, for lack of a more accurate description – nanotechnology may change the characteristics of the substances the technology interfaces with.  This may occur at the earliest stages of developing a use for nanomaterials, but its ultimate impact may not be seen or even measurable for years or generations.  Very little is known about this process.  At the nanolevel, some substances may be absorbed into the human body in unanticipated ways.  Now place this into the exposure chain, and the problems of characterizing and measuring risk increase exponentially.

 I will continue to sort through the Report and its relevance to nanotechnology in future posts.

http://www.cdc.gov/exposurereport/pdf/FourthReport.pdf

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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

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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.

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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/

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Risk and State of the Art

Posted Apr.13, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Litigation, Products Liability, Safety, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

In product liability litigation, product sellers often rely on the so-called state-of-the-art defense.  By raising this defense, the seller – usually the product manufacturer – argues  that the risks or hazards of the product complained of in the current litigation were not known to it at the time the product was designed, marketed, and sold to the user or consumer.  As with everything in the law, arguments abound as to how to define the state of the art.  For example, manufacturers have argued that the state of the art should be defined as the industry standard at the time.  This was essentially the argument made by asbestos insulation products manufacturers in the seminal case of Borel v. Fibreboard  Paper Products Corp., 493 F.2d 1076 (5th Cir. 1973).  The court had a very different view, however.   Reflecting concerns that using the industry standard to define the state of the art at any point in time would encourage entire industries to be lax in conducting research on the hazards of their products and/or disseminating information about known hazards to the public, the court held the manufacturers to the standards of experts in the industry.  The court defined this as follows:

The manufacturer’s status as an expert means that at a minimum he must keep abreast of scientific knowledge, discoveries, and advances and is presumed to know what is imparted thereby.  But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.

Id. at 1089-90.

Plaintiffs, on the other hand, prefer to define the state of the art to reflect technology on the cutting edge of scientific knowledge at the relevant time.  This concept would limit use of the state-of-the-art defense to a much smaller group of cases and result in broad liability for product sellers.  This view completely ignores whether making the product safer was feasible at the time or whether the utility of the product was greater than the possibility of any dangers it might create.  At the extreme, sellers could be absolutely liable for any and all injuries from their products.  Thus, in Beshada v. Johns-Manville Products Corp., 447 A.2d 539 (N.J. 1982) – another asbestos failure-to-warn case – the court refused to recognize the state-of-the-art defense on policy grounds because the manufacturers were in a better position to bear the losses associated with their products, and spread those costs, than the injured victims.

But the prevailing view allows product sellers to rely on state of the art as a defense to claims for defective products.  The Third Restatement of Torts:  Products Liability (1998) refers to “the foreseeable risks of harm” as a basis of liability for defective design and failure to warn of the hazards of a product.  But what is foreseeable?  All lawyers know the answer to that question is unclear and very fact specific.

Which brings us to the risks of nanotechnology.  What should we demand of sellers of nanotechnology and the products making use of the technologies?   Should the burdens of research into the risks be greater or less because the technology is developing?  Whether or not regulation occurs, personal injury litigation will arise at some point.  It seems inevitable, given the course of other consumer and workplace products.

One thing is clear:  It will not suffice for defendants to argue that they were not aware of the potential hazards of their products if they did not conduct research into the health and safety impacts and apprise themselves of all other available and pertinent research results.  If concerns arise from initial research (as they have in some studies of nanoparticles), their obligation is to conduct further research and to use the information in product design decisions or to provide sufficient warnings.  The words of the Court of Appeals in Borel resonate here:  “But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.”

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