Category: Safety

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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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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Nanotechnology, Biotech Patents, and Personalized Medicine

Posted Apr.08, 2010 under Bionanotechnology, DNA Nanotechnology, Health, Nanobiotechnology, Nanomedicine, Safety, Statutes
http://www.techwall.org

http://www.techwall.org

As technology in the bioscientific realm advances, there is an emerging body of law pertaining to patents on biological material, which focuses squarely on the hotly contested areas of personalized medicine and nanotechnology.  Personalized medicine is the practice of creating therapies for the specific genetic profiles of patients and their diseased cells.  Examples of the nanotechnology involved include cancer treatment, bio sensors, bio markers, bio imaging, and drug delivery systems.  The controversies are beginning to form and the potential for litigation is building.  Are these inventions worthy of patent protection?  What happens to these particles after they perform the specific task they were designed to carry out?  Is it a health issue, environmental issue, both?  These are the types of inquiries I am interested in exploring.  By no means do I purport to have expertise in ANY of the myriad fields I plan to touch on, but I am curious, though, and look forward to initiating a robust dialogue with those who are experts or those who are passionate about the direction of the law in these areas.

With that being said, I would like to begin with a broad and general overview of the current patentability issues.  The first hurdle in the patent process is actually having something that is patentable subject matter.  The nexus of the debate is 35 U.S.C. § 101 which provides:  “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.”  The statute is inherently ambiguous and has enjoyed broad interpretation, when applied by the courts, to determine if something is actually patentable subject matter.  See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (statutory subject matter “include[s] anything under the sun that is made by man.”).  However, the statute does not afford limitless possibilities and probabilities to the inventors of the world.

There are three specific categories that are off limits to the powers afforded by obtaining a patent:  the laws of nature, physical phenomena, and abstract ideas.  Diamond v. Diehr, 450 U.S. 175, 185 (1981).   The primary reasoning for unpatentability was articulated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), whereby the Court reasoned that, although these three categories could be discovered, they ultimately “are the basic tools of scientific and technological work.”  The rationale is simple, if these basic building blocks of nature were allowed the protective rights of a patent, specifically the right to exclude others from practicing the inventions or discoveries, the world of research would be drastically encumbered and hindered.  These excluded categories, the basic building blocks, are utilized by scientists, inventors, and theorists to create patentable subject matter.

While the discovery of any of the three excluded categories does not qualify for patentability, the application of them that leads to a new and useful process, machine, manufacture, or composition of matter, may very well lead to a patent, including those that have helped to fuel the explosion of scientific research in biotechnology.  Diehr, 450 U.S. at 187.  Those developments have spawned the creation of personalized medicine.  Science is moving forward and is forcing the law to keep pace.

The paradigm to determine the patentability of nanotechnology related to biological material might be altered in the near future due to the Supreme Court hearing the case of In re Bilski (the discussion of this case and the implications of the opinion has the potential to occupy many future posts).  The Court heard oral arguments on In re Bilski on November 9, 2009, and the forthcoming opinion in that matter will have an impact on the patentability of processes, including those that have helped to fuel the explosion of scientific research in biotechnology.  As a result, the development of personalized medicine hangs in the balance.

In addition to the legal, scientific, and ethical debates, there are the personal policy concerns.  A few worth mentioning are those relating to autonomy, freedom to make decisions about resolving/preventing health issues, the right to feel safe about the treatments we receive, and the list goes on.  The point I am trying to make is that we are on the precipice of a new era with the interaction of nanotechnology, personalized medicine, and the law, and we stand to gain more than we could ever have imagined or we stand to lose more than we ever bargained for.

Personalized Medicine Coalition,

www.personalizedmedicinecoalition.org/communications/TheCaseforPersonalizedMedicine _5_5_09.pdf

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