Nanotechnology: A New Force For Human Betterment - Part II

Monday, April 5, 2010 - 01:00

The Editor interviews John R. Bashaw, Partner in the New Haven office, William S. Rogers, Jr., Partner in the Boston office and Joseph Clark, Counsel in the Florham Park, New Jersey office of Day Pitney LLP.

Editor: Please discuss the recently published EPA Significant New Use Rule (SNUR) under the Toxic Substances Control Act for multi-walled carbon nanotubes.

Rogers: Before the EPA announcement in January, 2010 concerning the proposed SNUR, a series of studies was done beginning in the United Kingdom with a study led by Poland, et al. (2008). That study involved the injection of multi-walled nanotubes into the abdomen of mice, the mucosal lining of which is identical to the mesothelium of the pleura or chest. The injection directly into the abdomen was intended to simulate exposure of the mesothelium in the chest due to inhalation exposure. Approximately 90 days later they examined the biological changes who had taken place as a result of exposure of the abdominal mesolthelial lining to the carbon nanotubes. They reportedly found evidence of inflammation that was consistent with the type of inflammation that had traditionally been recognized in people who had inhalation exposure to asbestos fibers and who later developed mesothelioma. They did not find actual mesothelioma in the mice, but rather what were thought to be precursors to such cancers. The result of publication of these findings was an alarmist reaction that carbon nanotubes posed a danger to humans analogous to that of asbestos fibers. This became headline news.

The problem with the study was that the mice were exposed to massive doses of nanotubes by injection, which is not a natural or likely cause of human exposure. The test methodologies were a poor analog for what likely human exposure would be in any setting. Many commentators criticized the study's findings and suggested that its conclusions about a potential relationship between carbon nanotubes and asbestos fibers was flawed because it rested largely on their shape similarity (long and thin); however, for the last two years there has been talk in the popular media about whether the risks associated with all nanomaterials are akin to those associated with asbestos fibers. The only similarities between carbon nanotubes and asbestos fibers is their long aspect ratio, unlike other nanomaterials. There has been more focus on carbon nanotube toxicity than on other nanomaterial substances, which has percolated up to the EPA. EPA has now decided to treat carbon nanotubes separately from other nano-objects.

Bashaw: The proposed SNUR you mentioned is one that EPA has been toying with for over a year under the Toxic Substances Control Act (TSCA). This is currently one of the primary federal regulatory and statutory schemes for regulating nanoparticles. Under TSCA, people who want to manufacture or import a new chemical substance have to go through a pre-manufacturing notice process. If chemical substances that are already in the market can be identified as having a significant new use, EPA can impose certain restrictions on how they are used. EPA has proposed a new rule for multi-walled carbon nanotubes. Companies that require workers to wear gloves and wear National Institute of Occupational Safety and Health (NIOSH)-approved respirators while handling certain multi-walled carbon nanotubes will not be required to receive pre-approval from EPA for the use of these materials. This proposed SNUR is focused on only one particular form of a multi-walled carbon nanotube. The importance of this regulation is that it is the first one of major significance that EPA has promulgated for a nanomaterial. It gives a signal to the regulated community of the direction that the agency intends to take. EPA is soliciting input from users of these new materials on their toxicity and health effects so that they can better formulate regulations targeted to these materials.

Editor: What new regulations governing the introduction of nano-products can we expect and from which government agencies?

Bashaw: EPA is one of a number of agencies that are beginning to take the lead, primarily under TSCA. I expect to see very soon a change in EPA in terms of its "general approach" to determine if a nanoparticle is a new or existing chemical substance. In 2008, EPA took the position that if the macro form of a nanoparticle is already on the TSCA chemical substances inventory, then the nano form of that material does not require separate listing, pre-manufacture notice or health and safety studies.

We have learned much since 2008. One thing that we have learned is that the nano form of a particular compound may act in a manner 180 degrees different from its macro form. Because of that, there have been hints that EPA may announce that there is going to be a change in EPA's general approach. I think that you are going to start seeing more of these proposed SNURs and regulations being adopted under other sections of TSCA to require the submission of toxicology data on many of these compounds.

There are other federal regulatory programs that have some impact on nanomaterials: for example, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that regulates pesticides; the FDA regulates the use of nanomaterials in cosmetics, sunscreens - things that you would put on your body or ingest; OSHA obviously regulates workplace safety. While none of those current regulatory programs is targeted to nanomaterials, I think that you are going to start seeing that happening in the very near future under all of these programs.

Rogers: Another agency is the Consumer Product Safety Commission (CPSC) which has new authority and supposedly new funding under the Consumer Product Safety Improvement Act of 2008. They are supposedly going to get a stepped-up regulatory enforcement staff and with that the resources to examine new products under a host of federal consumer and environmental health and safety schemes. There has been a lot in the news lately about lead in children's products and the presence of substances called phthalates, which is a substance used to soften plastics. The CPSC banned three of the six commercially available phthalates. Now we are seeing talk about cadmium, a toxic substance, which is being used now in lieu of lead by some manufacturers in China, primarily in children's jewelry. Ultimately the CPSC will devote some energy in looking at the use of nanomaterials, initially, nanotubes used in carbon fiber products like those used in sporting goods, or consumer products. Tennis rackets, golf clubs and some vehicles, like bikes and personal watercraft, already include nanomaterial components. They will likely receive scrutiny not so much at the point of sale but as they are exposed to wear and tear during use. For example, what is happening in terms of dermal exposure to the nanomaterials as they are coming off on people's fingers or skin during use?

Editor: What prospective governmental regulation should be adopted to provide against toxicity and injury to humans but at the same time not impede the growth of this new science?

Bashaw: Senator Lautenberg of New Jersey is proposing some far-reaching amendments to TSCA. The EPA has already signaled its intention to propose rules under TSCA that will seek out new toxicology data on existing nanoparticles that are chemical substances. Before the agencies jump to prescriptive regulations which could stymie the industry, we have to keep in mind that this is truly a global marketplace when it comes to nanotechnology. If regulatory efforts are undertaken that stem its growth in the United States, other countries are going to move forward and leave us behind. The first step is to collect as much information as possible on the toxicology of these materials and try to assess, based upon that information, what type of regulation we need for these particular compounds. It appears that that is where the agencies are heading right now.

Rogers: There needs to be a peer governance over the scientific community so that studies that are undertaken to assess nanomaterial safety are done using appropriate and accepted scientific methodologies. What is not needed are the hasty conclusions from short-term studies that lead to hysterical findings that will be published in the popular media (as was true in the case of the multi-walled carbon nanotubes). We need people who are making appropriately designed studies using proven methodologies to come up with relevant data that will bear on human health and environmental safety.

Clark: Rather than wait for the government to intervene and propound regulations, interested stakeholders can and should participate in standardization efforts that are currently underway. For example, the American National Standards Institute ("ANSI") (www.ansi.org), has an accredited Technical Advisory Group to the International Organization for Standardization's technical committee on nanotechnologies ("ISO") (www.iso.org), and both ASTM International (www.astm.org) and IEEE (www.ieee.org), as well as many other organizations, have active panels dedicated to standardizing various areas of nanotechnology. My personal experience is primarily confined to the ANSI Technical Advisory Group, and ASTM efforts, and both groups are involved in creating global standards in a variety of areas including environmental health and safety, metrology and characterization, nomenclature, and material safety data sheets. Participation in any of these efforts is really a great way to become involved in building a foundation upon which the industry can grow and flourish.

Editor: Since this is a global industry, I assume other countries are handling this burgeoning data in different ways. Is there something to be learned from them?

Rogers: We are learning from them as the ISO organization has member bodies all across the globe of which the United States is one. It is a democratic process where people postulate potential approaches, all the member bodies comment on those - back and forth - and these things get revised over time until ultimately they are in a form where the member bodies can pass on them by way of a vote and they become an international standard principle. Actually Joe and I are involved in the ANSI-Technical Advisory Group which, among many other things, is looking at safety and labeling concerning nanomaterials; we expect that standards will be created in the not-too-distant future. The European Union uses the precautionary principle regarding nanomaterial regulation, which most people in the U.S. would prefer not to adopt. Different people have different approaches, but there needs to be compromise so that we come to a more global, standardized approach. As Americans we want our country to benefit and prosper from the opportunities that this innovative area offers us. The potential for nanoscience and nanomaterial engineering to give Americans and people around the world a better quality of life is at our doorstep. We just need to make sure that it is developed in an appropriate manner so that the benefits far outweigh the costs at every point along the spectrum.

Editor: What would you suggest to an owner of a factory as a website that he could review? Are there individual websites relating to different products?

Rogers: There is no one website that will necessarily offer you the guidance that you need to address a specific problem. If you want to begin the process on your own, and do some due diligence in assessing the risks and hazards associated with your manufacturing processes, you should probably go to a couple of different resources. The first that I would recommend is the website of the National Institute of Occupational Safety and Health. NIOSH has published a couple of nanotechnology-based best practices guidelines.

As John mentioned last month, there also is the "GoodNanoGuide" (http://www. goodnanoguide.org) which is maintained by ICON - the International Council on Nanotechnology - a consortium of stakeholders, governmental agencies, NGOs and Rice University, among others. Readers who are interested in seeing what their peers are doing should visit the site and can also reach out to the GoodNanoGuide's Dr. Kristen Kulinowski from Rice University, who will introduce you to that resource, which is an interactive database for sharing best practices.

Lastly, there are a couple of pilot projects of major corporations who are partnering with non-governmental safety organizations, such as DuPont's partnership with the Environmental Defense Council, which is considered leading edge.

Bashaw: Readers can also pursue links from our own blog site at www. thenanonewswire.com.

Part I of this article can be viewed at http://www.metrocorpcounsel.com/articles/12275/nanotechnology-new-force-human-betterment-part-i.

Please email the interviewees at jrbashaw@daypitney.com or wsrogers@daypitney.com or jclark@daypitney.com with questions about this interview.