Category: Research

Will Nanoparticles Be the New Asbestos?

Posted Oct.18, 2010 under Environment, Health, Litigation, Nanobiotechnology, Nanotoxicology, Nanotubes, Products Liability, Research, Safety, Toxic Torts
http://www.techwall.org

http://www.techwall.org

The course of asbestos litigation is well known, as is the fact that there appears to be no end in sight.  Is nanotechnology producing the next asbestos?  Some groups are working to prevent nanoparticle litigation from following in the steps of asbestos litigation.

In 2009, the United Kingdom’s Institute of Occupational Medicine (IOM) issued a report asking the question whether High Aspect Ratio Nanoparticles (HARN) – most notably, carbon nanotubes – create some of the same health risks as asbestos fibers.  The fiber-like features of HARN, although man-made rather than naturally occurring, may or may not interact with the human body in asbestos-like ways. The importance of determining whether HARN raise similar health risks cannot be overstated.  These issues have yet to be resolved, with potential health risks lurking in the interim.  As is often the case, development of new technology has flown past the scientific community’s ability to determine and assess the technology’s risks.

Looking back at the history of asbestos litigation, some burning questions need resolution sooner rather than later.  For example:

●  Do HARN fibers remain in vivo or do they degrade before disease processes are initiated?

●  If HARN are shown to persist in the body, what is the likely impact on workers?  In the asbestos context, the impact was seen in thousands of workers who developed debilitating progressive obstructive lung disease and/or malignant mesothelioma.  Do HARN have the capacity to produce similar health problems?

●  Even if HARN do not appear to behave directly like asbestos fibers, could HARN cause other, unknown, adverse health effects?

●  What broader impact might HARN have outside the workplace, including consumer and environmental exposures?

Are we headed down the same litigation road with HARN that we traveled with asbestos?

The asbestos litigation debacle in the United States began modestly enough with workers’ compensation claims, which were first denied and eventually routinely paid.  When asbestos insulation workers successfully brought actions against the manufacturers of the products they used in the workplace, the litigation expanded exponentially and has continued to challenge the court systems.

How can we avoid another asbestos?  The answer begins with research, knowledge, and awareness.

1 Comment

Nanolessons from the BPA Debate

Posted Sep.12, 2010 under Chemicals, Cosmetics, Drugs, Environment, EPA, Food, Health, Nanotoxicology, Pesticides, Research, Safety

Lab beakerThe New York Times recently published an article reviewing the state of research on the adverse health effects of the chemical bisphenol-A (known as BPA), which is found in plastic used for many consumer products.  BPA is a hot topic right now, both in the health and political arenas.  The reason is that BPA has been shown in some studies to mimic the hormone estrogen, which is considered an “endocrine disruptor” capable of causing harm to humans.  But whether BPA, in mimicking estrogen, actually causes harm has yet to be determined.

Some of the concerns about conducting and interpreting the health studies on BPA are instructive as we go forward with studies on the health effects of nanosubstances.

 Some particularly instructive observations in the article are:

 1.  Some scientists have noted the conflicting results in existing studies.  Some have suggested that the inconsistent results are, at least in part, a function of different laboratories studying the chemical in different ways:  “Animal strains, doses, methods of exposure and the results being measured – as crude as body weight or as delicate as gene expression in the brain – have all varied, making it difficult or impossible to reconcile the findings,” according to the article.

 2.  Even when experiments appear to be conducted identically, the interpretations may vary among scientists of different disciplines, using different standards.

 3.  In studying BPA and many other chemicals and substances (including nanosubstances), it is particularly important to be aware of the different ways the substance may act on adults, children, and fetuses exposed in utero.  Moreover, adverse impacts on fetuses include not just fetal development; a person born with fetal exposure could develop future exposure-related health problems during his or her lifetime.

 4.  Private laboratories tend to be the first to use new advances in research, while the government researchers tend to lag behind.  It is not clear which type is likely to yield the more accurate results – the new techniques or the tried-and-true techniques.

 In thinking about studying the health effects of nanotechnology-based substances, it is important to keep in mind these points.  Because nanosubstances are available for so many and varied uses, determining the actual health impacts will take time, money, and a coordinated effort among scientific disciplines.

Now is the time to move forward with just such a coordinated effort.

 The article on BPA is available at:

http://www.nytimes.com/2010/09/07/science/07bpa.html?th&emc=th

2 Comments

The Gulf Spill and 9/11: What These Disasters Can Teach Us About Studying the Health Impacts of Nanotechnology

Posted Sep.02, 2010 under Chemicals, Cosmetics, Drugs, Environment, EPA, Food, Governmental Interaction, Health, Nanomedicine, Nanotoxicology, Pesticides, Research, Safety
Wikimedia

Wikimedia

What do the Gulf oil spill, the attacks on the World Trade Center on September 11, 2001, and nanotechnology have in common?  On the surface, it would seem to be nothing.  But all three involve responses to potential health and environmental threats that are instructive about how we as a society respond to such threats.  Collectively, they raise some important issues regarding how our society views health and environmental risks in general.

 Don’t get me wrong.  In no way am I suggesting that nanotechnology is comparable to the disasters at Ground Zero or in the Gulf.  Rather, I am asking that you look at how government and funded research institutes manage long-term health and environmental effects that occur as a result of chronic low-dose exposures over time.  The potential health hazards of nanotechnology fall into the long-term category.  We don’t expect to see any acute health problems associated with nanotechnology, but we should be concerned about long-term exposures, and existing efforts to study the effects should be expanded.

 Let’s contrast what happens when there is a disaster.

 On August 19, 2010, administration officials reaffirmed their commitment to the recovery and restoration of the Gulf in the aftermath of the Deepwater Horizon oil rig explosion and the subsequent movement of oil into the waters and the ecosystems of the Gulf.  The media outlets have been full of video, photographs, and articles about the efforts of many organizations, companies, and governmental entities to clean up and minimize the potential harm to natural resources, the environment, and all forms of life.

 Not so long ago, something similar went on at Ground Zero in the aftermath of the collapse of the World Trade Center towers following the 9/11 terrorist attacks.  Early on, the focus of efforts at Ground Zero was on the search for survivors.  On September 29, the focus turned to recovery and cleanup, including removal of debris.  But even before that date, the federal, state, and local governments were engaged in managing the environmental disaster that resulted from the release of hazardous substances into the air, including asbestos, silica, lead, mercury, polycyclic aromatic hydrocarbons (PAHs), dioxin, polyvinyl chloride (PVC), Freon, and polychlorinated biphenyls (PCBs), to name a few.  Workers from FDNY, NYPD, Port Authority of New York and New Jersey, emergency medical personnel, and a host of volunteers worked at the site.

 It is easy to assign massive resources to the acute phase of a disaster, but much harder to sustain interest and funding as time goes on.  Eventually the media will move on to other stories now that the Macondo well is just about sealed, as it eventually did when the cleanup at Ground Zero was completed.  Funds have been established to make payments, lawsuits commenced.  But what lingers is the reality of long-term health effects that could emerge over time – ecosystem damage or cancer or other health risks.  Society has a certain myopia about such things.  Perhaps it is human nature to not want to think about the health problems that could arise years down the line.

 The protracted task of developing valid scientific studies on the health effects of any exposures, including nanoparticles, and interpreting the results is as essential as responding to the acute phase of a disaster.  Disasters like the Gulf spill and 9/11 suggest a kind of false dichotomy – that acute harms are more worthy of recognition in the law than chronic long-term harms.  The long-term harms may seem less urgent, but there is nevertheless an urgency about them as well.

 For example, following the Exxon Valdez oil spill in 1989, no concerted effort was made to assess the health effects of the cleanup on workers.  Years later, surveys told the story of respiratory and neurological illness.  This month, the National Institute of Environmental Health Sciences announced it would begin a study of the potential health effects of exposures of workers and residents as a result of the Gulf oil spill.  Even in the 9/11 context, where health screenings of Ground Zero responders have been ongoing since 2002, and a data base has been established, acceptable compensation has come nearly a decade after the disaster.  The law is slower to recognize the harms from chronic exposures, and slower to act to both compensate the injured and prevent further harm.  Clearly, some of this is a result of symptoms and other harms emerging over time.  But this is all the more reason to be vigilant and investigative from the start.

 Far from the spotlight of a high-profile disaster, and in the absence of a clearly exposed population to screen, studies on the health and environmental effects of exposures to substances about which we know little is essential.

 As mentioned, nanotechnology is not a disaster.  Far from it.  It is a means for creating better medical therapies, making some of our technology perform better, and offering consumers desirable features in everyday products such as textiles and cosmetics.  But this does not eliminate the need to make a concerted effort to study the long-term health and environmental effects of nanoparticles and nanomaterials.  No matter how long it takes; no matter how far out of the spotlight.

 For those interested in knowing more about the toxic aftermath of Ground Zero, see my article, Toxic Torts at Ground Zero, 39 ARIZ. ST. L.J. 383 (2007).

On the need for studies of the health impact of the Gulf spill, see

Gina M. Solomon & Sarah Janssen, Health Effects of the Gulf Oil Spill, J.A.M.A. (Aug. 16, 2010), available at http://jama.ama-assn.org/cgi/content/full/jama.2010.1254v1

1 Comment

Following the TSCA Bill

Posted Aug.01, 2010 under Chemicals, Environment, Governmental Interaction, Health, Nanotubes, Regulation, Research, Safety, Statutes
www.h20technologies.com

www.h20technologies.com

I previously commented on the House bill that would amend the Toxic Substances Control Act (TSCA) by updating it to include more substances, more disclosure, and expedited review by EPA.  On July 29, 2010, the House Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection held a hearing on the bill (H.R. 5820).  Certain themes emerged from this hearing.

 Theme 1:  The Economy.

 ●  Jobs.  All agreed that a major goal should be to avoid the loss of more jobs.  This may mean that legislation updating TSCA may proceed more slowly than the current bill would require.  This, in turn, would stall regulation of nanotechnology through TSCA.

 ●  Expense and difficulty of compliance.  Cal Dooley, President and CEO for the American Chemistry Council, representing the large chemical manufacturers in the industry, expressed concern that the increased burden and costs on manufacturers, and the longer time frame for EPA to review submissions, would result in a delay in bringing new chemicals to market and would force manufacturers to other countries.  He stated:  “We would export innovation and jobs instead of products.”

 ●  Foreign competition.  This theme was especially emphasized by Beth D. Bosley on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA), representing small chemical manufacturers.  She argued that H.R. 5820 “poses overwhelming challenges for the industry,” including the loss of innovation and chemical manufacturing to foreign markets.  She feared that the “substantive loss of high-paying manufacturing jobs will result.”

 Theme Two:  Defining a Scientific Standard

 ●  The Hearing indicated that this is certain to be a sticking point in the debate to come over H.R. 5820.

 ●  Cal Dooley of the American Chemistry Council stated:  “[T]he safety standard as established in this bill sets such an impossibly high hurdle for all chemicals in commerce that it would produce technical, bureaucratic, and commercial barriers so significant they would be the law’s undoing.”

 ●  In contrast, Richard Denison, a Senior Scientist of the Environmental Defense Fund, praised H.R. 5820 for assuring that “the best and latest science” be used for risk-based safety determinations.

 Theme Three:  Impact on Industry Innovation

 ●  Some witnesses presented testimony that H.R. 5820 would spur industry innovation by raising U.S. chemical standards to a level that would allow American companies to compete in a global economy where disclosure of information has become important.

 ●  In contrast, as the representatives of the chemical industry argued, concerns exist that innovation in the chemical industry will be exported abroad and that proprietary information will be compromised.

 What about nanotechnology?

 Though not a pervasive theme, the Hearing had some mention of nanotechnology.  Richard Denison, a Senior Scientist with the Environmental Defense Fund, said the following about the current state of nanotechnology regulation:

 “EPA has had little choice but to resort to pleading with the emerging nanotechnology industry to provide, through a voluntary program, the most basic information EPA feels it needs to decide how best to regulate these materials – only to see a level of participation best described as paltry.  Such materials can by no means be assumed to be benign; for example, one class of nanomaterials – multi-walled carbon nanotubes – behaves in a manner that is ominously similar to asbestos.”

 http://energycommerce.house.gov/documents/20100729/Denison.Testimony.07.29.2010.pdf

 Regulation of nanotechnology is coming, one way or another.  It is time to have a full discussion and debate on how best to achieve that, for the interests of the public, workers, and industry.  Currently, it appears that debate on the bill will resume in earnest when the next Congress convenes.  Let’s hope that the debate addresses these critical questions.

 Transcripts and video from the hearing may be accessed at

 http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2095:hearing-on-hr-5820-the-toxic-chemicals-safety-act-of-2010&catid=129:subcommittee-on-commerce-trade-and-consumer-protection&Itemid=70

2 Comments

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.

2 Comments

Remote Control Behavior: The Latest Development in Magnetic Nanoparticles

Posted Jul.15, 2010 under Artificial Molecular Machines, Bionanotechnology, Health, Nanobiotechnology, Nanomedicine, Research

nanotechnology-on-health-area-photoThe University of Buffalo recently unveiled a dramatic development in the nanotech realm. Through the use of magnetic nanoparticles it is possible for scientists to “remotely control ion channels, neurons and even animal behavior.” There are many possible real-world applications of this technology including targeted cancer, diabetes, and neurological disorder treatments.

The method utilized in the control of animal behavior involves the use of magnetic nanoparticles which have entered into the cell membrane of the nematode C. Elegans. The size of the particles, only six nanometers, is essential for the easy movement into the cell membrane. Once situated, the subject was exposed to a magnetic field (much like the intensity of an MRI) and the nanoparticles were heated to 34 degrees Celcius (93.2 degrees Fahrenheit). The worms, which had been moving in a forward direction, move in the opposite direction when the temperature rose.


Group of C. Elegans worms prepared by UB team with nanoparticles at their sensory neurons respond to the application of a magnetic field. To learn more, visit http://www.buffalo.edu/news/11518

“We targeted the [magnetic] nanoparticles near what is the ‘mouth’ of the worms, called the amphid,” explained Arnd Pralle, PhD, assistant professor of physics. “You can see in the video that the worms are crawling around; once we turn on the magnetic field, … most of the worms reverse course. We could use this method to make them go back and forth. Now we need to find out which other behaviors can be controlled this way.”

The implications of this breakthrough could just as easily be applied to humans. Already, there are groups utilizing magnetic nanoparticles to battle cancer cells in a very targeted manner. But, the net is cast wider with the application to remotely controlling animal and human behavior.

In the legal arena, one could pose the question “Is this discovery worthy of patent protection?” Post Bilski, 2010 WL 2555192, the question might easily be answered with regard to patentable subject matter and processes. Now that the machine or transformation test is not exclusively definitive, it is more likely than not the process of heating magnetic nanoparticles to cause a living organism to behave differently would clear the first hurdle on the path to a patent. Of course, the battle would continue in the ‘non-obvious’ and ‘prior publication’ stages, however, innovation is not stifled and the legal battles rage on.

Leave a Comment

Patentable Subject Matter Paradigm Evolves: Bilski’s Impact on Nanotechnology

Posted Jul.01, 2010 under Artificial Molecular Machines, Bionanotechnology, DNA Nanotechnology, Litigation, Nanobiotechnology, Nanomedicine, Research

supct

The paradigm to determine the patentability of inventions involving nanotechnology and biotechnology continues to evolve due to the Supreme Court deciding the case of Bilski v. Kappos, 2010 WL 2555192.  The Court heard oral arguments on November 9, 2009, and the opinion was issued on Monday, 28 June 2010.

The trouble for Bilski began when he and his business partner, Warsaw, applied for a patent on a computerized method for incorporating weather information into the speculation of future prices of commodities and energy costs (business method). The claim was denied by the Patent and Trademark Office (PTO) for lack of patentable subject matter (process), and the denial was affirmed in subsequent appeals to the PTO and the Federal Circuit. The Supreme Court decision affirmed the denial of the business method’s patentability, but it simultaneously held the test, utilized by the Federal Circuit, for determining if a process is proper patentable subject matter was not the exclusive and sole determining factor. Going forward, this decision will have a major impact on what constitutes patentable subject matter (the first hurdle on the road to a patent being issued), including those discoveries that have helped to fuel the explosion of cutting-edge bio/nanotechnology.

BACKGROUND OVERVIEW

Throughout the litigation history, the focus was squarely on the ‘machine or transformation’ requirements articulated by the PTO and further solidified by the Federal Circuit.  The court relied on the two prong test set forth in Gottschalk v. Benson to determine whether a process claim is tailored narrowly enough. “A claimed process is surely patent-eligible under § 101 if:  (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” The Federal Circuit outlined the task at hand, “It is undisputed that [Bilski’s] claims are not directed to a machine, manufacture, or composition of matter. . . . Thus, the issue before us involves what the term ‘process’ in [the law] means, and how to determine whether a given claim . . . is a ‘new and useful process.’”  Essentially, the legal issue generating all the consternation and strife is: “[W]hat test or set of criteria governs the determination by [PTO] or courts as to whether a process is patentable?”  The Federal Circuit opined that a process is not patentable subject matter unless it exactly conforms with the ‘machine or transformation’ test.

THE SUPREME COURT

The Supreme Court agreed to hear the case, but rarely hears a case from the Federal Circuit to explain that they reached the correct and appropriate conclusion. Quite to the contrary, the Supreme Court seems to take case after case in the patent area to fix a wrong perpetrated by the Federal Circuit. This tension has been in place for quite some time.

At oral arguments before the Supreme Court, Justice Sotomayor voiced concern over the harsh majority opinion of the Federal Circuit:

How about we say something as simple as patent law does not protect business matters instead of what the Federal Circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling will impose in the computer world, in the biomedical world, all of the amici who are talking about how it will destroy industries?

That sentiment reverberated in the unanimous majority opinion whereby the ‘machine or transformation’ test was relegated to the role of a helpful clue in determining whether or not a process is patentable subject matter. Essentially, the Court rejected the Federal Circuit’s exclusive reliance on the bright-line rule and threw the proverbial ball back into their court to develop an appropriate test. The bottom line, as it stands now, is that patentable subject matter is still quite broad, and the analysis to determine it includes the ‘machine or transformation’ test as one criterion with regard to processes, but it no longer is the sole deciding factor.

ONWARD

If the Supreme Court had required strict adherence to the machine or transformation test, it would have had seismic implications for patents already issued, and certainly would have caused trouble for pending applications relating to biotechnology and nanotechnology.  The trouble arises from the precarious position that biotech and nanotech patents are not theoretically involved with either a machine nor do they transform matter.  Generally speaking, they are processes involved with analysis, diagnosis, treatment or some type of function. Notable examples are those nanoparticles involved in drug delivery. Even though the particles behave differently at the nanoscale level, they essentially are not transformed or part of a machine and would thus fall outside patent protection under the rigid Federal Circuit test. Now, there is a least the possibility for these types of inventions to move forward in the process of patentability.

Ultimately, the parties in Bilski did not receive the patent on the specific business method that was applied for; however, the patent world at large was able to avoid the strictures of the rigid, bright-line ‘machine or transformation’ test utilized by the Federal Circuit .  In essence, the fields of nanotechnology and biotechnology research and development dodged a catastrophic bullet. In the coming weeks and months I plan to return to this discussion in relation to emerging technology, especially after the PTO, practitioners, judges, and legislators have had time to digest the nuances of this landmark decision.

2 Comments

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.

1 Comment

Nanobots, Patents, and Collaboration

Posted Jun.15, 2010 under Artificial Molecular Machines, Bionanotechnology, DNA Nanotechnology, Nanobiotechnology, Nanomedicine, Research
Wikimedia

Wikimedia

It is clear that the time has come to integrate cutting-edge science and the law.  In addition to the policy issues involving individuals, it is important to our nation because we must continue our leading role as the innovators of the world.  Furthermore, there is a tremendous amount of money at stake for our economy.  Historically, the method by which to protect the vast amount of money that is invested and earned from scientific research is patent protection.  That must continue.  However, a possible starting point for compromise is collaboration between scientists who invent a new and useful product, derived from biological material, and those who wish to utilize the technology to further the development of particular areas of science leading to additional inventions.

A prime example of a partnering between two groups of scientists in the realm of nanotechnology and biotechnology is that of the DNA robot.  Researchers from Columbia University, Arizona State University, and Caltech have created a Nanobot that follows a programmable path on a surface patterned with DNA (more commonly referred to as DNA origami). Simultaneously, researchers from New York University, led by Ned Seeman, have combined multiple DNA devices to make an assembly line. The DNA robot picks up gold nanoparticles while navigating along a DNA-labeled surface.  The details were released in the May 13th edition of Nature:  http://www.nature.com/nature/journal/v465/n7295/pdf/nature09012.pdf.

Essentially, scientists are at the beginning stages of creating test-tube factories that have the potential to create self-assembling computers, rare chemical compounds or autonomous medical robots able to embark on specialized missions in the human bloodstream. “[We’re] moving from individual entities that do something interesting to systems of entities working on something with a more complex behavior and function,” says Lloyd Smith, a chemistry professor at the University of Wisconsin-Madison.

The California Institute of Technology has applied for a patent on DNA origami, invented by Professor Rothemund.  NYU owns a patent on nano-robotics as a result of the pioneering research conducted by Professor Seeman.  The collaborative effort of these two groups reflects the benefits that are possible through non-enforcement of patents in the early stages of scientific development.  Furthermore, as a result of the partnering, it would be unnecessary for the government to get involved in the regulation of innovation.  A natural outflow of a collective approach would be the development of self-regulating industry standards to shape and guide the evolution of  the interaction between science and the law.

1 Comment

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

Leave a Comment