Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

Throughout the report, the author addresses the unique, and in some cases, not so unique, concerns raised by using nanomaterials in food packaging, all through the use of hypothetical applications.  The purpose of the report is to "tee-up" the regulatory issues faced by the FDA, as the primary regulatory agency in charge of food packaging, and the EPA as a secondary regulating authority.  The report provided a broad based look at the issues raised by this specific nanomaterial application.

Like other areas of potential regulation, the use of nanomaterials in such close proximity to food raises its own concerns and potential.  Beyond the discussion raised by the paper itself, which are absolutely worth considering, it is encouraging to see the GMA involved in this study.  Because of the number of regulatory topics that are emerging, and each one seemingly unique to its own industry of application, it becomes critical for stakeholders to involve themselves in the debate. 

In the paper (find an abstract here), the authors focus on the potential shortcomings of federal regulation of nanomaterials, and ultimately, "suggest some ways government agencies can be better prepared to address nanotechnology risk knowledge gaps and risk management."  The primary thrust of the paper is that state and local government will likely have to address risks and concerns of nanomaterials in the absence of complete information.

State and local regulation of nanomaterials is quickly becoming a favorite topic, and one we've been discussion for a while now (see two of our more recent posts here and here).  And while it appears that Wisconsin may jump into the pond soon on nano regulation, nothing concrete has developed yet.

How states address the risks and concerns of nanomaterials, which at the same time addressing the existing data gap, will be just as important as federal action on the subject.  States are in the precarious position of not wanting to stifle an emerging, and potentially lucrative in terms of jobs and tax revenue, industry, but at the same time they have an obligation to keep their residents safe.  I look forward to reading the full paper and read the suggestions proposed by Maria Powell, Martin Griffin, and Stephanie Tai.

The author, Michael Berger, lists the following five problems with regards to a lack of consistent nanotechnology standardization:

• "no internationally agreed terminology/definitions for nanotechnology
• no internationally agreed protocols for toxicity testing of nanoparticles
• no standardized protocols for evaluating environmental impact of nanoparticles
• no standardized measurement techniques and instruments
• no standardized calibration procedures and certified references materials"

In addition, there are no fewer than seven organizations with competing nanotechnology standards statements, including ASTM, ANSI, IEEE, and ISO--all well respected organizations.  In addition, the nanotechnology standards debate has been going since at least December of 2003.

Well, this got me to thinking.  In an instance of life imitating life, the competing technical standards for nanotechnology closely resembles the diverging regulatory standards that are developing (oh, c'mon, you knew where I was going with this didn't you?).

For example, take a look at the three state statutes concerning the definition of "nanotechnology."  Each of Michigan, Arkansas, and Oklahoma have enacted binding, statewide laws concerning what defines nanotechnology:

• Arkansas, A.C.A. §15-4-2103(5): “Materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size;"
• Oklahoma, 74 Okl St. Ann. §5060.4(12): “‘Technology developed at the molecular range (1 nm to 100 nm) to create and use structures, devices, and systems that have novel properties because of their small size;"
• Michigan, M.C.L.A. 206.30 -125.2088a: “Materials, devices, or systems at the atomic, molecular, or macromolecular level with a scale measured in nanometers;"

Now, take a look at the bold sections.  All three of these statements concerning the size of nanotechnology have slightly different meanings.  In fact, only one, Oklahoma, actually defines nanotechnology as existing between 1-100 nanometers.  While this may not seem to be an overly important consideration now, imagine what these further regulations in these states will look like with diverging bases.  Add to these emerging state statutes the previously discussed Berkeley standards, and the forthcoming Cambridge standards, and a very murky picture begins to develop indeed. 

While I am not suggesting that there should be one, all-inclusive set of regulatory standards for nanotechnology, I am suggesting that we need to be mindful of these diverging paths and strive to reduce uncertainty and confusion by the regulated community as these standards develop.  Just like consistent technical standards will provide certainty to the scientific community, developing regulatory standards with an eye towards consistency will provide certainty for the regulated community.

The information is coming from EurActive (via Nanowerk because the EurActive website is down as of this posting), and it is citing a European Commission official who stated a document to be published this Spring will argue that current EU laws and regulation sufficiently cover nanotechnology and nanomaterials.

The European Food Safety Authority is expected to release a study  on risk assessment and nanotechnology issues, but there are no indications as to what that report may reveal at this stage.  It is also unclear if this is the report that EurActive is referring to.

I think its too early in the process to try and predict what the official recommendations to the Commission will be.  And, even then, the Commission will be free to take or leave the recommendation as it sees fit.  Just because the recommendation is to not enact new legislation or regulation, doesn't mean new legislation won't be forthcoming.  But, it looks like a report is imminent, which will shed some light on this rumor.  Stay tuned.

Among the items Maynard criticized is the practice of carbon nanotube manufacturers to submit MSDS sheets for SWNTs that effectively mirror those for regular graphite.  This is a practice I also identified as problematic in my remarks before the Nano App Summit in Cleveland on October 22nd.  However, in the absence of clearer safety data, I don't know that it's unreasonable to provide warnings to workers based on the source material and then to additionally warn workers of "potential" inhalation and other risks. 

In any event, among the six steps Maynard advocates are the following:

Create a new federal advisory committee to allow transparent input and review from industry, scientists, labor groups, nongovernmental organizations and other stakeholders; [and]

***

Appoint a top-level government leader responsible for the action needed to address the environmental, health and safety challenges of nanotechnology.

In his comments, Maynard criticizes what he terms as disconnects between administrative agencies and contends that NNI is not sufficiently well-funded and is not focused clearly enough on environmental, health and safety issues.  One example of the "disconnect" Maynard dislikes is the fact that NIOSH filed a public comment on EPA's TSCA paper from this past summer in which NIOSH disagreed with EPA's proposed regulatory framework for nanomaterials under TSCA.  Instead, Maynard believed that NIOSH should have been communicating with EPA through "back channels."  While I recognize Maynard's general point that the federal government needs to coordinate as well as it can, I actually don't mind the transparency that comes with agencies communicating through "front channels" rather than "back channels."  Say what you will, but the public disagreement between NIOSH and EPA on the TSCA regulatory issue certainly has drawn attention to the issue and enriched the public debate in a way that "back channel" lobbying would not have.

First, Johns Hopkins University recently announced that students will be able to minor in "nanotechnology risk assessment and public policy."  Faculty from the engineering and public health programs received a grant to offer the curriculum.

"The new minor will involve courses on topics such as risk science and public policy, ethics and law, environmental engineering, public health and toxicology. Faculty members who will develop or teach the courses are affiliated with the Institute for NanoBioTechnology, Whiting School of Engineering, Bloomberg School of Public Health and Krieger School of Arts and Sciences, as well as the Risk Sciences and Public Policy Institute, Berman Institute of Bioethics and Center for Law and the Public's Health."

Second, in Tempe, Arizona, three professors at the University of Arizona's Sandra Day O'Connor College of Law received a $314,000 grant from the US Department of Energy to "develop models for the international regulation of nanotechnology."  The grant will cover approximately 3 years worth of work, and will be used to:

• "create and maintain a public online database of proposed and enacted regulatory requirements and programs specific to nanotechnology at the international, national and local levels.
• analyze proposed and enacted national and local regulations for nanotechnology, including the consistencies and inconsistencies of requirements in different jurisdictions.
• prepare case studies of nine transnational models for the oversight of various technologies, with analysis of their strengths and weaknesses.
• propose and evaluate potential frameworks for the transnational regulation of nanotechnology and coordination of national regulatory strategies."

These two schools are essentially turning out the first generation of nanotechnology regulators.  While those of us in the system now are learning as we go, students in both programs will be taught nanotech regulatory issues from the beginning of their careers.  What's also interesting is that these programs are addressing the regulatory issues from different perspectives, which should lead to differing views and debates on laws and regulation. Perhaps even a cross-university conference is in the making here?

The article begins by setting forth the arguments that have been presented for stricter regulation of nanotechnology, as well as the context for why stricter regulation is being called for.  The Group then sets forth the arguments against stricter regulation, and an analysis of each objection.  Each analysis, while brief, is thoughtful and presented to provide a balanced look at both sides of the debate for stricter regulation.

However, what makes this article particularly noteworthy is that it presents a straightforward, and rather simple, alternative to stricter controls.  Noting that passing new laws and promulgating new regulations is not easy, the Group suggests "running faster to catch up."  That is to say, testing methods and regulatory planning should be accelerated in order to keep pace with nanotechnology development.  In that way, the data gap that everyone admits exists will begin to close, while contingency regulatory plans are put into place should testing data reveal a serious problem.  In this way, nanotechnology research and development, as well as testing and regulatory development can all proceed in concert.

This is a novel approach (novel in the sense that I haven't seen anyone suggest it), which deserves thought and consideration.  Like most other "hot topics," the solution to the question of regulation will need to consist of a compromise between all interested parties.  Those interested and involved in the debate should read this article and give some thought to the solution proposed.  The Group admits that there are questions present with its proposed compromise, and even then it is likely only a temporary measure while more is learned.  However, it strikes me as a reasonable step in the development and control of this technology.

Finally, the Group touches on a thought that I wanted to state more plainly here.  The article asks the question that assuming "current laws are inadequate, would new or stronger laws be enough to fill that gap?"  To me, that poses the next logical thought (well, logical to me anyway): perhaps then, the answer is not more or stronger laws and regulations, but rather, different laws and regulations.  Specifically, those that take into account this new area of science and technology that current laws were not designed to address.  Perhaps the long-term answer is a new set or series of laws and regulations that are developed and authored to directly address the development and control of nanotechnology.  Admittedly, we are not there yet, but, along with the other issued raised by the Group, something to consider.

About The Nano Ethics Group:

Founded in 2003, The Nanoethics Group is a research & education organization - not an advocacy, activist or watchdog group. What makes us different is that, where other organizations have already made up their minds either for or against nanotechnology, or are tied to certain interests, we have no agenda other than to keep an open mind and go where analysis & common sense lead us.  More information can be found here.

 These are NNCO's five proposed categories:

Instrumentation, Metrology, and Analytical Methods

The priority research needs for this category provide an integrated approach essential to understanding, predicting, and quantifying the chemical and physical properties and behavior of nanomaterials.  The priorities under this research category underpin, and are fundamental to, all five categories of EHS research and information needs.

Nanomaterials and Human Health

Research on human health often involves complex, interrelated scientific concepts that are investigated most efficiently by a parallel, rather than serial, research paradigm. This parallel structure permits the investigation of single or integrated research questions and the leveraging of progress in related areas. Evaluation of the human health research needs against this paradigm and the value-of-information principle led to identification of an overarching research priority. The task force identified five broad research needs that are critical to addressing this overarching priority and to establishing the fundamental principles for nanomaterial interactions with living systems. Overarching Research Priority: Understand generalizable characteristics of nanomaterials in relation to toxicity in biological systems.

Nanomaterials and the Environment

The priority research needs for this category represent those that were presented in the EHS Research Needs document, with revisions to ensure complete coverage of environmental issues.

Health and Environmental Exposure Assessment

Research in this category is aimed at assessing exposure to, rather than hazards of, nanomaterials * * *.  The priority research needs for this category identify work to enable the collection of exposure information. Data collection should group individuals into exposure categories and relate groups potentially exposed to nanomaterials, including workers, patients, consumers, and neighbors of production or utilization plants. * * * Information on the process, task, and location variables should be evaluated to understand how nanomaterials behave in workplace environments and what factors determine the exposures to nanomaterials in such environments.

Risk Management Methods

The many research needs for this category, as identified in the EHS Research Needs document, were grouped by the risk management methods task force into five broad research needs, which were then prioritized. The broad research needs are listed below, ranked from highest to lowest priority. The task force recognized one of the research needs identified in the EHS Research needs document as encompassing the overarching research priority for this category. Overarching Research Priority: Evaluate the appropriateness and effectiveness of current and emerging risk management approaches for identifying those nanomaterials with the greatest potential risks.

The Task Force, however, did recognize that the unique properties of nanomaterials could at some point create challenges with respect to product safety and effectiveness. To that end, the Task Force recommended the consideration of agency guidance that would clarify what information manufacturers should provide to the FDA about products utilizing nanotechnology and would clarify the circumstances under which the use of nanomaterials would change the regulatory status of particular products. The report also recommends that the FDA assess its data needs to better regulate nanotechnology products, develop in-house expertise on nanotechnology issues, and create mechanisms that will ensure the consideration of new nanotechnology information as it becomes available. Finally, the report encouraged the FDA to evaluate the adequacy of current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials.

The Task Force's report can be found here.

The Task Force was created in August 2006 to assess regulatory approaches that encourage the development of safe and effective FDA-regulated products that use nanomaterials, and the Task Force held a public meeting on these issues on October 10, 2006.

Similarly, Senator Mark Pryor's office indicated a report addressing nanotechnology research and regulatory efforts at FDA, EPA, OSHA, and the Consumer Product Safety Commission by the General Accounting Office (GAO) is due out in the Spring of 2008.

Check back for more information on both of these reports as they are released.

The White Paper, as expected, lays out the Agency's thoughts and ideas concerning nanotechnology and how EPA will treat it.  While the Paper begins with the Agency's role in the larger government plan concerning nanotechnology, it provides many EPA-specific items as they relate to research and regulation.

The Paper begins with EPA explaining EPA's role with regards to nanotechnology, as well as why nanotechnology is important to the Agency.  It then addresses issues such as risk assessment and development of nanotechnology from EPA's perspective.  Not surprisingly, EPA identifies several areas in which clear data gaps exist and must be filled in order to progress with nanotechnology.  However, of particular interest to those in the regulated community, the Paper provides some of EPA's thoughts on both potential regulation of nanotechnology, as well as its possible environmental benefits.

First, with regards to possible regulation by EPA, the Paper explains that the Agency maintains the position that current environmental statutes provide it with the authority to regulate nanomaterials.  This statement alone is not surprising as it is a generally accepted thought.  However, the Paper fails to discuss how some of these statutes contain trigger levels that may be inappropriate measures of nanomaterials.  For example, statutes such as the Clean Air Act and Resource Conservation Recovery Act contain measurable levels at which regulation begins, such a specific concentration or weight emitted or discharged.  Because nanomaterials may be a concern at vastly smaller measurements, many of these triggers that are measured in parts-per-million or pounds or tons emitted may be inapplicable; a point EPA does not fully develop.  Similarly, EPA spends significant space on potential environmental harms, but also explains that nanotechnology may also provide environmental benefits, especially in terms of ground water or Superfund site remediation projects.  It is important to remember that nanotechnology can be a positive in remediation efforts, not just something to regulate for protection.  EPA does a good job remember this point, and should be commended for taking a two-vision approach: understanding remediation possibilities and understanding risk possibilities.

Second, the Paper goes into great detail concerning risk assessment.  EPA believes it is very important to develop sound risk assessment concerning nanomaterials before moving to the next step.  The Agency then reiterates its desire to work with stakeholders to develop the necessary information to make educated decisions. 

Finally, the Paper concludes with a series of recommendations directed at EPA offices and staff.  If EPA holds to these recommendations, the Paper provides a good road map as to the Agency's priorities in the near future.  While EPA's work in nanotechnology will be largely driven by the research of research and risk assessment projects, its overall thoughts on nanotechnology provide a well-reasoned beginning its work in the field. 

MV: Why would Berkeley, specifically, make this a regulation? Is there a lot of handling of nano-materials there? Or would this set precedent for California state, and/or perhaps the rest of the country?

JCM: The short answer is Berkeley primarily wanted to be a trendsetter, and secondarily wanted a forward looking ordinance to prevent any potential future problems. Officials in Berkeley have openly criticized the federal government and the state of California for failing to enact nano-specific safety regulations. They have also openly said they enacted their own ordinance because state and federal governments failed to act first. Also, while the ordinance is not binding legal precedent, Berkeley has openly encouraged other governments -- city, state, and federal -- to follow their lead.

As for actual application, currently there are very few companies using engineered nanoscale materials in Berkeley. (In fact, several newspapers have reported there are "none," but I do not believe this is accurate.) So, I would not say the ordinance was enacted because of any impending current safety concern.

On the other hand, University of California Berkeley labs and Lawrence Berkeley National Laboratory are both in the city limits. Both are involved in nanomaterials research. Berkeley says the ordinance was initially prompted by a lack of nanomaterials handling procedures at these two labs. The city claims to have asked the labs what nano-specific safety procedures they had in place, and the answer was "none or very few." This prompted Berkeley's original concern and ultimately the ordinance. However, Berkeley has also now stated that the ordinance does not apply to either lab because they are federally funded. The labs, on the other hand, intend to voluntarily comply with the final ordinance.

MV: Why specifically is this legislation unnecessary? Is it because we don't yet know whether nanomaterials are actually a threat? Or because there is simply a lack of data proving either way - dangerous vs. safe?

JCM: I believe this specific legislation is unnecessary because (i) it is virtually impossible to comply with in its current form, (ii) the federal government should take the lead in labeling any material/chemical as "hazardous," not Berkeley (iii) all "manufactured nanoparticles" - whatever that broad definition used in the ordinance implies - have not been label as "hazardous," nor is there any current scientific consensus that they all should be.
There are data on both sides of the safety/hazard issue, but I do not believe any responsible scientist is dismissing the potentially negative data out of hand. It is a real concern. However, most scientists say more research is still needed and it will take several years. They also advocate the standardization of research techniques to make sure they are all talking about the same thing as they move forward with research.

MV: Who should be doing this research to determine whether nanomaterials are safe? Companies, etc.?

JCM: The federal government is funding nano-related environmental, health, and safety research - about $44 million is in the 2007 budget. However, there seems to be a consensus among scientists that federal funding should be increased to at least $100 million annually. On the other hand, the federal government takes the position that manufacturers are primarily responsible for the research necessary to ensure the safety of their nano-products. Ultimately, product liability law imposes this same burden on manufacturers. As they must ultimately bear the social and financial burden of any liability, I believe manufacturers should plan accordingly. However, my personal belief as a policy matter is that manufacturers and the federal government have equal responsibility.

MV: Now, regarding this regulation, who does the burden fall to to provide the required information? The companies? Will this cost companies time, money, manpower? Could you please provide more detail on how this legislation is a burden to industry?

JCM: The burden falls on the companies to provide the required toxicology information. There are a couple of ways to answer the question depending on what the city wants, which isn't crystal clear.
If the city says all that is required is a literature search (most likely), then my response is that reviewing the universe of existing toxicology studies and then reporting/summarizing them to the city is a very expensive prospect. You will have to ask a toxicologist for an estimate of the actual hours this research would take. There are over 1600 EHS studies in the best nano-database. A lot of them, of course, might not be applicable to any individual company or situation. But if you take the Cosmetics, Toiletry and Fragrance Association’s white paper on nanoparticles in personal care products to the FDA as an example of the type/level of analysis required, the required effort will be quite large and expensive indeed.

If new toxicology research is required (less likely), then that is a whole different (greater) level of expense.  There are also additional expenses associated with implementing the materials handling plan portion of the ordinance once the toxicology issue has been resolved. Of course, this is hard to estimate without having the toxicology part nailed down.

MV: Where else is this pre-emptive legislation surfacing?

JCM: This same type of current preemptive legislation is being considered in Cambridge, Massachusetts. I would look for similar efforts in nano-university communities across the country. Additionally, companies located in "top ten" states for nanotechnology development should be closely watching what's going on at the municipal level.

MV: Also, at what stage would it NOT be considered pre-emptive? Once safety data is in-hand?

JCM: City governments are not well-equipped to analyze these issues. Thus, I would always consider municipal regulations of this specific type to be "preemptive" and ill-advised. The federal government is looking very closely at nano-EHS issues, I would leave the decision to it as to whether or not to label a nanomaterial as "hazardous" and all the burdens that come with that label.

The draft agenda for Council's December 5 meeting includes, as "new business," a first reading of an ordinance entitled "Manufactured Nanoparticle Health and Safety Disclosure."  This ordinance is an amendment to Berkeley Municipal Code Sections 15.12.040 and 15.12.050, addressing disclosure requirements for hazardous materials and waste management.  Those immediately impacted include the University of California-Berkeley and the Lawrence Berkeley National Laboratory, both of which conduct nanotechnology research within Berkeley City Limits.  The San Francisco Chronicle reports that the amendment  is being urged by the Community Environmental Advisory Committee "because so little is understood about the possible impact of the materials on human health."

The draft ordinance is also asking that letters be sent to elected officials asking them to earmark a percentage of funds included in the National Nanotechnology Initiative's annual budget for health and safety research.

Updates on the progress of this ordinance will be posted as they become available.

As initially reported, the EPA's Office of Pollution Prevention reversed its course from earlier statements, and ultimately decided to regulate nanosilver under the FIFRA.  EPA reasoned that because manufacturers were producing products containing nanosilver as a method of killing bacteria, such uses were properly the province of the FIFRA as a pesticide.  Nanosilver is found in several products available today, including food containers, shoes, air fresheners, and bandages.  The concern is that the silver may pose a threat to aquatic systems as a bio-accumulative toxin.

Upon further research into EPA's announcement, it has been determined that EPA plans to issue a Federal Register notice that will explain the requirements for using nanosilver as an anti-bacterial agent.  Greenwire is reporting that the rule will be issued "within the next few months."  It is expected that those falling under this new rule will need to show that the nanosilver additive will not pose an environmental risk when placed into commerce.  However, as reported in the November 23, 2006 Washington Post article, EPA states that to be subject to FIFRA regulation, there has to be a claim that the product will "kill pests" in order for it to be a pesticide.  Consequently, products containing nanosilver may not be subject to FIFRA regulation absent a claim that the product kills bacteria, viruses, or the like.

The most important piece of information to come out of this subsequent research is the knowledge that EPA will indeed begin regulating nanomaterials, and plans to do so soon.  Silver is already regulated under the FIFRA in several products as a pesticide, so for EPA to regulate forms of nanosilver is potentially a new step.  The Federal Register notice should provide additional details as to how nanosilver will be regulated under the FIFRA and the procedures EPA will use in determining which uses are subject to regulation and which are not.  It is important to note that nanomaterials are not currently regulated, however it appears as though regulation is now imminent, starting with nanosilver in anti-bacterial uses.

The three panelists discussed their views on regulation of nanomaterials.  All agreed that more information is needed before firm policy can be developed and that additional funding, especially in the area of health and safety research, is also needed.  Of particular note, Mr. Alwood noted that the EPA is focusing nanomaterials regulation under the Toxic Substances Control Act (TSCA) when those materials exhibit "unique properties" from those chemicals already appearing on the TSCA Chemical Inventory.  Mr. Alwood explained that a difference in the sizes of chemicals is not new to TSCA, and that to track with the National Nanotechnology Initiative definition of "nanotechnology," nanomaterials will likely have to display unique behavioral characteristics to warrant a repeated entry on the TSCA Chemical Inventory.  Mr. Alwood also referenced the Stewardship Program that EPA is developing, and referred listeners to the letter that was released by EPA on October 18, 2006 requesting the voluntary submission of nanotechnology research data to supplement EPA's research efforts concerning TSCA regulation.  That letter is available at http://epa.gov/oppt/nano/nano-letter.pdf

Next, Dr. Sass addressed the health and safety concerns raised by the manufacture of nanomaterials.  She was particularly concerned with the toxicological impacts nanomaterials may have when introduced into biological systems.  She believes more information is needed to properly address the risks posed by nanomaterials, and that research budgets should be increased accordingly.  She is particularly concerned over the inhalation dangers posed by nanomaterials, and cited to several laboratory experiments providing epidemiological data on health impacts.

Finally, Mr. Gulledge presented the manufacturer's perspective on nanotechnology, and tended to agree with the other panelists concerning data gathering and funding issues.  Of note, Mr. Gulledge pointed to recently released survey results presented by the International Council of Nanotechnology at Rice University.  Those survey results, available at, icon.rice.edu/projects.cfm, outline the findi