Category: Health

We would like to thank those of you out in cyberland who have found our blog – now only 9 months old – and have been interested in what we have to say about the emerging issues in nanotechnology and the law.  We hope that you continue to follow us in the coming months.

Writing a legal analysis blog has been a challenge.  Because of our interests in cutting-edge legal issues, in particular toxic torts and biotechnology, we have especially enjoyed the challenge of relating nanotechnology to existing and evolving legal doctrines.

Our promise for 2011 is to step up the pace of our posts while still maintaining our commitment to accurate and high-quality legal analysis.  As always, we welcome your comments on the blog.

Nanotechnology is a new frontier in the law, and we look forward to being able to offer readers our thoughts and insights on how the law will meet the challenges it presents.

 Best wishes for the new year.

nano 3On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review.  The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.

 The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials.  This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology.  It is a critical step toward reducing risks to human health and the environment.  But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.

 In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”

 The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.

The European Union may be further ahead.  On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes.  Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years.  Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.

 Even so, why so slow?  Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.


Sources (all by BNA subscription):

225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)

nano 5

In an earlier post, I wrote about the consternation surrounding patents on genes and the potential implications to the developing realm of nanotechnology.  Recently, an amicus brief was filed with the Federal Circuit by the Department of Justice (DOJ) opposing the patents that were issued to Myriad regrding the testing for breast and ovarian cancer.  Interestingly, the United States Patent and Trademark Office (USPTO) did not join the DOJ, which indicates an idealogical rift in the Obama administration.  It was reported that Mr. Kappos, current director of the USPTO, ”seemed chagrined that the Department of Justice was taking a viewpoint very different from the patent office.”

The following is an excerpt from the amicus brief Table of Contents which is rather revealing and informative regarding the government’s opinion on the matter:

A. Section 101 Embraces Only “Human-Made Inventions”
B. Engineered DNA Molecules, Including cDNAs, are Human-Made Inventions Eligible For Patent Protection
C. Isolated But Otherwise Unmodified Genomic DNA Is Not A Human-Made Invention
1. Unmodified Genomic DNA Is A Product Of Nature
2. “Isolation” Does Not Transform A Product Of Nature Into A Man-Made Invention
3. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is A Literal Composition Of Matter
4. Isolated Genomic DNA Is Not Rendered Patentable On The Theory That It Is “Pure”
5. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify

It is important to note that the DOJ is not advocating an all-out ban on patents on genes, just those that are ‘unmodified.’  Initially, this will allow for further development of the information contained in the genomic code.  It seems as though the big argument revolves around the pieces of the code that are isolated, but not changed in any way.  Proponents assert that there should not be the reward of patent protection based solely on finding that which already naturally occurs.  Opponents argue that invention and development of specified uses for these segments of DNA would be stiffled, and the United States’ position as a global leader in the life sciences would be severely compromised.

It will be interesting to watch the development of the subject matter as it works its way through the Federal Circuit, and presumably the Supreme Court.  Not only for the impact it will have on the biotechnology arena, but also on nanotech.  As mentioned before, many argue that the majority of inventions involving nanotechnology do not qualify for patent protection because they are not far enough removed from the naturally occurring material they are comprised of.  We shall see.

Link to the DOJ brief:

The U.S. National Nanotechnology Initiative (NNI) Strategic Plan Draft was posted at for public comment on November 1, 2010.  The NNI was launched in 2001 with 8 agencies and now consists of the nanotechnology-related activities of 25 agencies.  Fifteen of these agencies have R&D budgets related to nanotechnology.

In reflecting on the 10-year history of U.S. nanotechnology research and development, the NNI Draft highlights its work as having “established a thriving nanotechnology R&D environment, laid the crucial groundwork for developing commercial applications and scaling up production, and created demand for many new nanotechnology and manufacturing jobs in the near-term.”  (Draft, p. 1)  Looking to the future, the NNI notes that nanotechnology R&D is “far from full realization.”  (Draft, p. 2)  The goals of the NNI continue to be broad:  continued development of R&D; developing the technologies into products for commercial and consumer use; and developing the physical and human resources to achieve these goals.

Goal 4 of the Draft Strategic Plan is “Support responsible development of nanotechnology,” including the twin goals of understanding and managing the risks of the technologies.  Among the NNI participating agencies in 2010 are EPA, FDA, National Institutes of Health (NIH), and National Institute for Occupational Safety and Health (NIOSH).

The NNI Draft Strategic Plan focuses directly on the benefits of nanotechnology, rather than the risks.  But many of the participating agencies – and many more – need to be involved on the risk side of the proverbial risk-benefit analysis.  This is happening, as reported previously in posts on this blog ranging from FIFRA to TSCA to the FDCA.

 But equally important is the need for communication and coordination on both the benefits and risks of nanotechnology.  And that extends beyond governmental regulation to businesses and nongovernmental organizations (NGOs).

Aside from governmental action, various voluntary initiatives and partnerships have emerged.  A report out of the Woodrow Wilson  International Center for Scholars, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight:  Charting a Path,” gives an overview of the initiatives – some publicly sponsored, some developed by business, and some representing joint business-NGO partnerships.  These initiatives have the common, though separate, goal of developing a strategy to oversee environmental, health, and safety risks raised by nanomaterials.  The report is available at

Three initiatives discussed in some detail in the report are:

 ●  “Nano Risk Framework,” jointly developed by duPont and the Environmental Defense Fund (EDF)

 ●  “Responsible Nano Code,” sponsored by stakeholders from the United Kingdom

 ●  “Nanoscale Materials Stewardship Program,” developed by EPA

 The report critically analyzes these specific initiatives – as well as others more generally – and concludes that they have a welcome role in the future of nanotechnology safety and health efforts.

The ideal world does not exist, of course.  But in this world, a strategy that incorporates the risks and benefits of these developing technologies and brings together as many varied interests as possible representing all affected parties, including the environment, is warranted.  It can provide needed checks and balances along the way.

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.



The nexus of a large number of nanotech inventions, specifically related to personalized medicine, is biological material and other naturally occurring materials.  In order to obtain a patent, the inventor is essentially required to create a new composition of matter from that which occurs naturally.  Until recently, scientists and inventors alike have been able to satisfy this requirement, but change might be on its way.

In May 2009, the American Civil Liberties Union and the Association for Molecular Pathology filed suit, in the United States District Court for the Southern District of New York, against the United States Patent and Trademark Office and Myriad Genetics. The complaint pertained to patents that were granted on the BRCA1 and BRCA2 human genes that are mutations correlated to the increased risk of breast or ovarian cancer.  Myriad Genetics designed a procedure to test for these mutations to indicate the likelihood of a woman developing either or both of the diseases.  The complaint asserted that patents on genes should not be allowed because they are violative of § 101, patentable subject matter, of the Patent Act, namely all three of the judicially recognized exceptions to patentability:  natural phenomena, laws of nature, and abstract ideas. Subsequently, the American Civil Liberties Union and the Public Patent Foundation filed a motion for summary judgment, in August 2009.  On March 29, 2010, the District Court found that the isolated segments of DNA utilized for the diagnostic tests were “not markedly different from native DNA as it exists in nature” and held the patents granted to Myriad were not valid.  Ass’n. for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010) available at

This particular case involved the nature of medical tests utilized to screen women for the specific types of cancer.   Myriad holds (held) patents on the two genes that indicate the likelihood of the woman developing cancer.  Two main issues precipitated the litigation.  First was the fact that Myriad charges more than three thousand dollars for its exclusive Comprehensive BRACAnalysis test.  This exorbitant cost prohibited many women from being able to have the test, placing them at an increased risk of developing cancer.  It was asserted that if Myriad would license the test, the cost would become more reasonable and allow for more women to benefit from the technology.  This is the specific goal of personalized medicine; however that goal is more often thwarted by the exclusionary nature of patents (absent licensing and/or collaboration).

The second concern arose from those women who actually undergo testing and are delivered a positive diagnosis for possible development of cancer.  Because Myriad held the patent on the test, the women were prevented from obtaining a second opinion to confirm the results prior to deciding to undergo preventative surgery. Examples of such prevention include radical mastectomies and ovarian removal surgery.  The combination of these concerns cuts directly to the heart of the ongoing debate:

Should patents on biological material be allowed, and if so, what does that mean for the future of scientific research and the development of personalized medicine?

The precursor to this debate harkens back to the California Supreme Court case of Moore v. Regents of the Univ. of Calif., 793 P.2d 479 (1990), where the court was asked to decide if a cancer patient had any property rights in a commercially viable invention created from his particular cancer cells.  The court ultimately decided that the plaintiff did not have any property rights in his biological materials because they considered the material discarded.  The same debate takes place today with regard to human DNA, but no specific human has a specific property right to a specific segment of the human genome.  As a result, scientists are able to use raw DNA and patents on genes are issued if the inventor/scientist has isolated a particular gene from its naturally occurring form, essentially creating a new composition of matter.  However, in light of the decision in Myriad, the fate of thousands of patents (issued and pending) might be uncertain.

Of course, I will bring the focus back to the challenges awaiting nanotechnology in the fields of personalized medicine, molecular biology, etc.  As I stated in the beginning of this post, the nexus of a large number of nanotech inventions is biological material and other naturally occurring materials.  We know from the patentable subject matter paradigm, now including Bilski, that there still exists a broad spectrum of possibilities of what is considered a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof . . . .”  35 U.S.C. § 101.  But, is there restriction on the horizon as a result of the Myriad decision?  Only time will tell.    

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:



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



I recently came across a very interesting article that was written in the Summer of 2008, Nanoparticle-based Therapies in Humans: A Survey, available at The subject matter deals with medical therapies for humans that contain nanoparticles. The author explores the emerging area of medicine that incorporates nanotechnology to fill the gaps of traditional delivery systems (i.e. poor water solubility and lack of target specificity). In addition to gap filling, the therapies stand poised to take the medical field to a whole new level, and will pose a myriad of challenges for the FDA, the U.S. Patent and Trademark Office (PTO), and patent attorneys worldwide.

Some Broad Background:

It is important to understand why nanoparticles are responsible for the proliferation of a new way to deliver medicine to the ailing human body. Traditional delivery systems lack the specificity element and the medicine tends to be delivered in higher than necessary doses that could lead to possible toxic exposure to the patient. Also, the human body is a hostile environment which reduces the effectiveness of traditional drugs.

The author of the article pointed out the following benefits with regard to the developments in nanomedicine:

Nanoparticles are selected for properties such as biodegradability, biocompatibility, conjugation, complexation or encapsulation and their ability to be functionalized. There are two types of nanoparticle-based therapeutic formulation: (1) those where the therapeutic molecules are the nanoparticles (therapeutic functions as its own carrier); and (2) those where the therapeutic molecules are directly coupled (functionalized, entrapped or coated) to a carrier.

Another important and desirable property of nanoparticles is the “surface area effect” that occurs. As a particle’s size decreases, the number of atoms on its surface increases relative to those at the core. This results in an exponential increase in reactivity which equates to increased efficiency and effectiveness over larger molecule delivery systems.

Patents and Commercialization:

It is critical for a company to obtain valid patents if they have any hope to profit from the research and development efforts of producing a new drug delivery system. According to the author of the article I read, the current state of nanoparticle patents is confusing at best. He states, “the proliferation of nanoparticle patent applications filed at the PTO, coupled with the continued issuance of surprisingly broad patents by the PTO, is creating a chaotic, tangled patent landscape where competing players are unsure as to the validity and enforceability of numerous issued patents.”

In an earlier post, Nanobots, Patents, and Collaboration, I proposed that innovation through collaboration is likely the most ideal way to navigate in this emerging area of technology. It seems as though there is no clear guidance in light of the Bilski decision, other than the probability is high that broad patents will continue to issue (not a bad thing, but not helpful to those involved in developing the multilayered drug delivery systems). I find myself a bit conflicted because I am a proponent of patent protection, but I am a realist and understand that the smaller the technology goes, the more overlap that occurs between competing patents. Again, I assert that collaboration is key and I look forward to participating in the process.

I previously discussed the recent efforts to expand and revise the interpretations of the Toxic Substances Control Act (TSCA) and the Food, Drug and Cosmetic Act (FDCA) to reach nanotechnology.  Simultaneously, efforts have been ongoing to expand and revise the interpretation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – the federal pesticide statute – to similarly encompass nanotechnology.  In particular, the proposed interpretation would require any nanoscale material used in a pesticide to be considered a new substance, and subject to adverse effects determinations in place for new substances, even if a non-nanoscale form of the same material has already been in a product registered under the act.

 This proposed FIFRA interpretation is clearly part of the trend to bring nanotechnology under existing regulations and confirm the authority of existing agencies to make determinations about the safety of nanomaterials.  But is this a good idea?

 One bone of contention in the proposed FIFRA interpretation is the proposed application of Section 6(a)(2) to require pesticide manufacturers to report the deliberate inclusion of intentionally produced nanomaterials in their products.  Section 6(a)(2) is often referred to as the “adverse effects” section of FIFRA.  The implication, therefore, would be that nanomaterials would be presumed to have adverse effects.  EPA says otherwise, however, stating that the proposed interpretation would emphasize data collection, while also including adverse effects.  EPA also says that the proposed interpretation would reach substances other than nanomaterials.

 The nanotechnology-related industries have reacted with sharp criticism of the proposed interpretation, though they continue to recognize that regulation is inevitable.  Several industry groups, most notably the American Chemistry Council, have expressed concern that the proposed interpretation would “stigmatize” all uses of nanotechnology in pesticides, especially because it would use the “adverse effects” section of FIFRA as the primary means of regulation.  They say other sections of FIFRA would be more neutral and less stigmatizing.  This may be the case and deserves further consideration.  On the other hand, if those other sections do not permit EPA to conduct the kind of safety analyses permitted under Section 6(a)(2), there would be no advantage to the public in applying the other sections instead.

 Furthermore, industry groups have rallied around the general debate over the health and safety of nanomaterials.  FIFRA officials have cited existing studies tending to show risks to human health and the environment from nanomaterials.  An industry group, the Silver Nanotechnology Working Group, has claimed that concerns for health and the environment are overstated, insisting that long-term data show nanomaterials to be safe.  This debate seems to be premature.  It makes little sense at such an early juncture – when some data exists, but more is clearly warranted – to argue that minimal regulation is the best way to go.

 Another major concern of industry has been the costs of preparing and producing the data that would be required under the proposed interpretation.

 (The reactions of government officials and industry mentioned above were reported in:  Pat Rizzuto, EPA Developing New Interpretation, Policy on Pesticide Law for Nanoscale Ingredients, 121 Daily Env’t Rpt. (BNA) B-1 (June 25, 2010).)

 As I’ve said before, there are positives and negatives to the trend of broadening the interpretation of existing federal statutes to include nanotechnology.  Some may be:


●  No need to wait for Congress to act

●  Officials are already familiar with the statutes, so start-up would be minimal

●  Health and environmental concerns would start to be addressed without substantial delay

●  Nanotechnology’s discrete uses may best be regulated within statutes and by agencies that are more specialized, each dealing with different uses


●  Is piecemeal regulation the best way to go, or is wholesale regulation a better approach?

●  Industry’s concerns may be ignored as the existing agencies go forward with the new interpretations

●  Potential conflicting decisions and interpretations among the various federal statutes

●  It is not at all clear that existing regulation, even if reinterpreted, reaches all of the unique issues presented by nanotechnology

 ***These concerns, and others, should be weighed in determining the best way to regulate nanotechnology.***