UK's The Guardian: "Less Than 2%" Of Nanotechnology Research Is Devoted To Risk Analysis

Posted by Jeff Klein on June 11, 2012

The UK’s The Guardian broadly reviews the on-going debate surrounding nanotechnology—namely, whether the benefits offered by nanotech materials outweigh the risks to the environment and to humans.  The article juxtaposes the uncertainty surrounding the risks of nanotech materials with its positive potential.  For instance,“[i]n the medical arena, nano-robots could be programmed to repair damaged cells and mimic our own natural healing processes,” or for the environment, “the effects of man on the environment could be halted and reversed through nano filters designed to remove carbon dioxide from the atmosphere.”

As The Guardian notes, the properties that make nanotechnology beneficial may be the exact properties that create the risk: "[a]s chemical substances get smaller, their behaviours and characteristics may change, with certain nanomaterials possessing properties not found in their bulk counterparts… the novel properties that nanomaterials can possess give rise to new forms of risk."  It is the uncertainty that makes the nanotechology debate important at this time, particularly since there are already "1000 nanotechnology enhanced products on the market" currently:

Potential risks from nano are both unknown and unknowable.  Unknown because little risk assessment has take place to date (less than 2% of the money being poured into nano research is devoted to risk analysis) and unknowable because scientific expertise in chemical assessment has not kept pace with scientific expertise in nanotechnology. Put simply, we are not currently capable of testing all of the inherent properties of all nanomaterials.

For this reason, comparisons between asbestos and nanotechnology run rampant.  According to the article, the first asbestos mines opened in Quebec in 1874.  Asbestos was widely used by various industries by the 1950’s.  While some concerns about the safety of asbestos were first noted as early as 1900, it was not for many years until asbestos came under any real scrutiny for being connected to any health concerns.  The uncertainty of the risks surrounding nanotechnology will most likely lead to increased government regulation in the very near future—particularly, if the government does not believe that the nanotech industry is proactively assessing the risk of its own products.

The article ends with an open question to consumers:

Simply ask yourself this question: when was the last time you ever picked up your body wash in the shower and scrutinised the ingredients list? And, even if you did notice "(nano)" next to an ingredient, what would that mean to you: a warning as to possible side effects? A selling point as to unique properties? Something else?

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

FDA Issues Industry Draft Guidance On The Use Of Nanotechnology In Food and Cosmetics

Posted by Jeff Klein on April 30, 2012

In April of 2012, FDA issued a draft guidance for the use of nanotechnology in both food and cosmetics.  While a draft guidance does not technically establish “legally enforceable responsibilities,” its purpose is to provde an agency's thinking on a particular issue in the form of tentative guidelines—here being the use of nanotechnology in food.  The draft guidance opens a period for comment from industry participants as to their opinion of the effect if the draft guidance were to be implemented as a regulatory standard.

In this particular draft guidance, FDA has opined that the use of nanotechnology in food may require additional "scrutiny" and, thus, it is best practice for industry participants using nanotechnology in food substances to consult FDA prior to marketing such products:

As with all food substances, this guidance also is intended to recommend that you consult with us regarding a significant change in manufacturing process for a food substance already in the market, irrespective of your conclusion about whether that change affects the safety or regulatory status of the food substance. It is prudent practice for you to do so, particularly when the change in manufacturing process involves emerging technology. Food substances may be used in a wide array of products manufactured, distributed and sold at retail by a large number of firms. The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant.

If implemented, the draft guidance may have significant impact on both the manufacturers using nanotechnology in their food substances and the nanotechnology firms developing and marketing nanotech applications for food substances as the use of nanotechnology in food will almost certainly increase in cost for all.  Requiring FDA consultation prior to taking a nanotech food application to market, including the necessary research and/or studies substantiating the safety of the intended nanotech food use to FDA, will create regulatory hurdles, lengthening the time and increasing the expense of developing and marketing nanotech food products and applications. 

Moreover, food substance manufacturers will likely require a more thoroughly reviewed safety profile of the intended use from nanotech firms both to convince the FDA as to the safety of its application and as "insurance" against future product liability claims.  In light of the FDA draft guidance, failure to properly investigate the safety risks of a nanotech application in food prior to marketing by either the nanotech firm marketing the nanotech application or the food manufacturer using the nanotech application in its food substances could expose both entities to liability from future product liability claims as the draft guidance will certainly be used as a standard for reasonable industry conduct.  Notably, even if the draft guidance is not implemented by FDA for some years to come, its issuance in itself can arguably be an informal standard of the "reasonableness” of a company’s actions and practices in the context of a product liability lawsuit.  Thus, any deviation from the draft guidance can be fodder for product liability lawsuits.

The Boulder business lawyers at Laszlo & Associates, LLC provide legal counsel to businesses on a variety of business needs including products liability, risk management, corporate protection and legal compliance.

FDA Takes An Interest In Nanotechnology

Posted by Jeff Klein on June 27, 2011

On June 9, 2011, the FDA issued a draft guidance on the applications of nanotechnology in FDA regulated products.  Particularly, the draft guidance is intended for public comment by manufacturers, suppliers, importers and stakeholders as to “whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.”  As the draft makes clear, while the FDA’s guidance documents do not establish “legally enforceable responsibilities,” they do describe the FDA’s "thinking" on a particular topic and should be viewed as recommendations for an industry.

In its draft guidance, the FDA listed two primary “Points to Consider” for public comment regarding whether a product contains nanomaterials:

  1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
  2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

The FDA’s draft guidance should be viewed in conjunction with the "Memorandum for the Heads of Executive Departments and Agencies, Re: Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” issued on June 9, 2011 and applicable to various Executive agencies.  Thus, the FDA's underlying focus, in light of the Memo on Policy Principles, is whether the particular “properties or phenomema” of nanomaterials pose certain public safety and health risks: 

In sum, agencies will continue their science-based approaches subject to the particular rules governing each area of regulatory oversight and their existing statutory authorities. Federal agencies that have regulatory responsibilities must continue to implement sound policies to protect public health, safety, and the environment…

Nanomaterials should not be deemed or identified as intrinsically benign or harmful in the absence of supporting scientific evidence, and regulatory action should be based on such scientific evidence. Where there is evidence of either safety or likely harm, the corresponding regulatory actions are usually clear. For some statutes, the mere existence of a hazard, regardless of the probability of it causing harm, may trigger some form of regulatory action. In general, however, and to the extent consistent with law, regulation should be based on risk, not merely hazard, and in all cases the identification of hazard, risk or harm must be evidence-based. In applying these principles, regulators should use flexible, adaptive, and evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling the Federal Government's responsibility to protect public health and the environment.

Along with the possible public health and safety implications of the FDA's interest in nanotechnology, some commentators also are viewing the increased government regulation in nanotechnology as a "glass-half-full," allowing for an increase in approved uses of nanotechnology--particularly, in an area such as medicine where there have been innovative uses of nanomaterials, such as carbon nanotubes, for cancer treatment (here and here) and treatment after a heart attack (here).  However, it will remain to be seen whether Washington’s interest in the field of nanotechnology will encourage its development and expand nanotech applications, or ultimately bog down and stifle the field with excessive regulation. 

Nanotechnology Makes It Possible For A Heartbeat To Power iPod

Posted by Jeff Klein on March 29, 2011

The news on the nanotechnology front evolves daily.  The Telegraph reported today that a team of scientists have developed a tiny microchip comprised of nanotechnology that could use movement to power portable electronic devices.  According to the article, "the technology works using zinc oxide nanowires, which generate electricity when strained or flexed."  Thus, simple body movements or even a heartbeat could create sufficient power to run iPods or cellular phones. 

Dr. Zhong Lin Wang, of the Georgia Institute of Technology, stated:

This development represents a milestone toward producing portable electronics that can be powered by body movements without the use of batteries or electrical outlets....Our nanogenerators are poised to change lives in the future. Their potential is only limited by one's imagination.

No doubt Dr. Wang's sentiment can be applied to nanotechnology as a whole: its application is potentially life-changing and limitless.

German Authorities Determine Insufficient Information Exists Linking Nanotechnology to Cancer -- However, The Available Findings "Should Be Taken Seriously."

Posted by Jeff Klein on March 28, 2011

As an update to our last post on nanotechnology ("Only Time Will Tell If Nanotechnology Will Be The 'New Asbestos'"), German authorities, comprised of the Federal Institute of Risk Assessment (BfR, the scientific body of Germany that prepares expert reports and opinions on questions of food safety and consumer health protection on the basis of internationally recognised scientific assessment criteria) and the Federal Environment Agency (UBA, the German central federal advisory authority on environmental protection), stated that despite various animal studies linking nanomaterials to cancer, there is insufficient information to label them as being “potentially carcinogenic to humans” at this time. Despite this pronouncement, German authorities did however state that sufficient concern remains to monitor nanomaterials and their effect on humans. 

The German authorities reviewed animal research studies in which nanomaterials, such as carbon nanotubes and titanium dioxide, were found to be carcinogenic in animals.  The authorities could not determine whether this causality necessarily translates to humans:

…the extent to which data from animal testing applies to humans and whether these effects are specific to the nanoscale or are rather due to other properties inherent to these substances is uncertain. 

Further, in conjunction with a dearth of research on the subject, the authorities stated that review of the effects of nanomaterials on humans is further complicated as there is “no reliable measurement technology to detect nanomaterials in different media.”  Thus, according to the German authorities, no reliable conclusions could be drawn from the animal research studies regarding the potential effects of human exposure to nanomaterials.  However, German authorities caution that the findings of the animal research studies linking nanomaterials to cancer  “…should be taken seriously.” 

Only Time Will Tell If Nanotechnology Will Be The "New Asbestos."

Posted by Jeff Klein on March 25, 2011

Nanotechnology litigation is not an “if,” but a “when”—so go the prognostications.  And for good reason: scant research by manufacturers, public uncertainty and fear, diverse and multiplying product use, and the “deep pockets” of the industry—all signs point to nanotech litigation in our near future.  However, the basis of these lawsuits, whether product liability, consumer protection, or environmental, remains to be seen.

The definition of nanotechnology is not entirely agreed upon.  The U.S. National Nanotechnology Initiative defines nanotechnology as “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers….involv[ing] imaging, measuring, modeling, and manipulating matter at this length scale.” (www.nano.gov/html/ facts/whatIsNano.html accessed on 03/25/2011.)  Other definitions tend to be a bit more simple: “nanotechnology is technology dealing with applications and products with engineered structures smaller than 100 nanometers.”  (Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies: Managing the Effects of Nanotechnology, J. Clarence Davies, p.7).  As a frame of reference, a nanometer is 1/800th the width of a human hair.

The nanotechnology field, while only approximately 10 years old, is a rapidly developing and expanding field—cars, airplanes, sunscreens, glasses, medicines, detergents, clothing, cosmetics, fertilizers, etc.  The use of nanostructured materials is seemingly endless.  Experts on emerging technologies predict over $1 trillion in sales of products using nanotechnology by 2014.  Further, it is estimated that by 2014, almost 15% of all manufactured products may rely on nanotechnology. 

However, the properties and behavior of nanotechnology cannot be predicted and thus are not fully understood.   Additionally, the very small size of nanotechnology poses a unique potential for exposure whether inhaled through the lung or absorbed through the skin.  Once within the body, nanotechnology may circulate through the bloodstream, affecting any part of the body.  Thus, while it is an exciting time for researchers, manufacturers, and even consumers, this excitement does not come without trepidation.  Few research studies have been conducted as to the potential adverse health or environmental effects of nanotechnology, thus it is uncertain if, when, or what these effects may be.  This is especially of concern for the many companies who have already brought nanostructured materials and products to market.  Their potential exposure to liability is immense, considering the public is already interacting daily with products using nanotechnology.

Take for instance, carbon nanotubes.  The use of carbon nanotubes is diverse and expanding daily: airplanes, semiconductors, fuel cells, electrical wiring, water desalination, sporting goods equipment, reinforced plastics, body armor, cancer therapy, to name just a very few.Carbon nanotube  Despite the seemingly endless application of carbon nanotubes, there has been some negative “press” that carbon nanotubes not only physically resembles asbestos fibers, but may cause lung inflammation and granuloma development, potentially leading to mesothelioma.  (Friends of the Earth Executive Summary: “Mounting Evidence that Carbon Nanotubes may be the New Asbestos.”)  Two studies have suggested that carbon nanotubes may cause asbestos-like pathogenicity or mesothelioma. (Poland et al., Nature Nanotechnology, “Carbon Nanotubes introduced into the body cavity of mice show asbestos like pathogenicity in a pilot study.” 20 May 2008; Takagi et al., “Induction of mesothelioma in p53+/- mouse by intraperitoneal application of multi-wall carbon nanotube.” J Toxicol Sci 33:105-116, 2008).  This is just one of the concerns of the adverse health effects of carbon nanotubes.  Not only have consumer rights groups turned their purview to carbon nanotubes, the U.S. government has also.  In 2010, the EPA began to enforce notice requirements when a company plans to manufacture or import products using carbon nanotubes.

Nanotechnology has the potential to offer immediate, wide-ranging benefits to our lives; whether those benefits outweigh their risks….only time will tell.