Archive for December, 2010
Posted on December 23rd, 2010 in Uncategorized | No Comments »
Posted on December 21st, 2010 in Uncategorized | No Comments »
This is a continuation of the program summary from Friday, December 10th at the Nanotechnology Innovation Summit http://www.nsti.org/events/NNI/
The keynote session featured two distinguished speakers, Representative Bart Gordon and Ambassador Richard Russell. Representative Gordon, as most of you know, has been a tireless advocate for in Congress for science, technology, and STEM education generally, and for the NNI in particular. He reminded us that the House of Representatives has passed the NNI Amendments Act twice – as a standalone bill and as part of the America COMPETES Act – but that so far the Senate has failed to follow suit on either lead. Rep. Gordon does feel there is still an outside chance for action this year, with his fellow Tennessean Senator Lamar Alexander championing the effort. Ambassador Russell, formerly Deputy Director of Technology at OSTP and now CEO of VIAforward, reminded us how unusual it is to have a coordinated multiagency initiative, with a growing budget across three administrations and substantial achievements toward stated goals. He attributed the success of the NNI to three factors: nanotechnology is relevant, receives bipartisan support, and has been championed in both the legislative and administrative branches. In reviewing the historical NNI budgets overall and by agency, Ambassador Russell pointed out that EHS research, NIH funding, and DOE funding have grown particularly rapidly.
Three more high-ranking Agency officials addressed Friday’s audience: Dr. Francis Collins, Director of the National Institutes of Health; Dr. Patrick Gallagher, Director of the National Institute of Standards and Technology; and Dr. Subra Suresh, Director of the National Science Foundation. Dr. Collins began his remarks with a return to the topic of international competitiveness, noting that a recent comment in Nature (Follow the money, Wang and Shapira) ranked NIH a gratifying fifth among all nanotechnology research funders internationally – four places behind the National Natural Science Foundation of China. Dr. Collins went on to describe discovery, diagnostic, and therapeutic nanotechnology research sponsored by the various Institutes which make up NIH. While the National Cancer Institute provides about 40% of the NIH total nanotech funding, he also reminded us of the significant research efforts at several other Institutes including the National Institute of Biomedical Imaging and Bioengineering, the National Institute of General Medical Sciences, the National Center for Research Resources, the National Heart Lung and Blood Institute, and his own previous home, the National Human Genome Research Institute. One of the newer therapeutic approaches he discussed was the use of nanoparticles to deliver siRNA, which has proved difficult to administer using conventional methods. Dr. Collins gave an example of new approaches the Institutes are taking to support researchers. By limiting eligibility for the Director’s New Innovator Awards to researchers who have not previously been NIH Principal Investigators, and through an application and review process that emphasizes creativity over detailed budgeting, NIH is trying to make it easier for young researchers to establish independent careers. Fifty-two researchers were funded in the first year of the New Innovator program. Eight of them – 15% of all those selected through a very competitive process – are working in nanotechnology.
Dr. Gallagher gave a very comprehensive presentation of NIST’s role in supporting technology development and advanced manufacturing. NIST’s participation in the NNI covers a range of activities within the agency’s broad mission, such as providing researchers (many of them from industry) access to state-of-the-art nanofabrication and characterization tools, producing standard reference materials, advancing and disseminating nanoscale measurement tools and techniques, and generating data and procedures to support the work of voluntary consensus standards groups. Dr. Gallagher noted that many of these can be loosely categorized as R&D infrastructure, for which he offered the definition “an underlying set of capabilities enabling research to move into practice.” One thing that kind of infrastructure does – with NIST’s EHS-related work being the big example in nano – is allow us to get risk management right. He also touted the Technology Innovation Program’s (TIP) extensive funding for nanomanufacturing R&D and for work on advanced nanomaterials. Dr. Gallagher’s talk was perhaps more focused on the second word in the Summit’s title – Innovation – than any other speaker’s. He singled out the Nanoelectronics Research Initiative as a spectacularly successful example of public-private partnership in innovation. He calculates the NRI leveraging of public funds to date as 73:1, and noted that the initiative, while maintaining its precompetitive nature, is moving on to a new phase. In the NRI’s first five years, a thousand ideas flowered. Now they are starting to select the most promising of those ideas for further development. Finally, he pointed out that three of the four goals in the NNI Strategic plan are squarely in the infrastructure space he described. While these goals are unchanged from 2004 and 2007 Plans, the draft 2010 Plan couples them more deeply into program planning, including calls for deeper international engagement and a full life cycle approach to EHS issues and responsible development. This should improve the community’s ability to manage and compensate risk and allow us to move forward in areas like sustainability and environmental stewardship, which Dr. Gallagher believes to be fundamental strengths of nanotechnology.
Dr. Suresh, who was confirmed as NSF Director less than two months ago, used the “Nano2″ report we recently pointed our readers to as the basis for his presentation. If you haven’t read Nanotechnology Research Directions for Societal Needs in 2020 yet, I suggest you download a copy from the web. Dr. Suresh comes to NSF from MIT, where he led a group researching the mechanical properties of both biological and man-made materials at the nanoscale. He sprinkled insights from his own research throughout his talk. For example he said that the ability to pull individual molecules with calibrated force is now routinely available in commercial instruments. Among the key Nano2 findings Dr. Suresh presented are these:
- The U.S. Federal investment exceeds $12B
- There are >50 nanotechnology-based drugs in clinical trial
- The U.S. market for nanotechnology-enabled products is estimated at $91B for 2009
- 60 countries now sponsor nanotechnology research programs
Looking forward, Dr. Suresh said NSF will continue to sponsor curiosity-based nanoscale science and engineering research while placing additional emphasis on commercialization of nanotechnology and measures to protect the public from any potential hazards.
The Friday company presentations covered nanotechnology innovations in the life sciences and in advanced materials. The life sciences session included Liquidia Technologies’ Joseph Desimone, Omid Farokhzad of BIND Biosciences and Selecta Biosciences, Cerulean Pharma’s Alexandra Glucksmann, and William Moffitt of Nanosphere.
Dr. Desimone holds the position of Science Advisor at Liquidia while continuing to head a major research group at the University of North Carolina, where Liquidia’s PRINT technology was originally developed. PRINT allows Liquidia to create nanoparticles with controlled size, shape, and surface properties. It is being explored for inhaled therapeutics, delivery of a wide variety of drugs, and even some non-medical applications. Liquidia’s leading vaccine candidate is an enhanced flu vaccine, which just entered Phase I clinical trials.
Dr. Farokhzad also has one foot in academia and one in industry. He is a founder of both BIND Biosciences and Selecta Biosciences. BIND is working on targeted delivery of nanoparticles containing anticancer drugs, cardiovascular drugs, or anti-inflammatories. Selecta, like Liquidia, is pursuing novel vaccine strategies, using the separately timed release of antigens, adjuvants, and T-cell memory antigens from engineered nanoparticles. They call these concoctions targeted Synthetic Vaccine Particles, or tSVPs. Dr. Farkhzad said people have been asking why Werner Cautreels would follow up a position as Global Head of R&D at Solvay, which was sold to Abbott earlier this year for $6.6B, with the CEO job at such an early-stage firm. The answer, obviously, is that billion dollar firms start small, and with “top quality investors” and a technical team including MIT’s Robert Langer plus Ulrich von Andrian and Dr. Farokhzad from Harvard Medical School, he thinks this is an interesting one.
Alexandra Glucksmann described two different technologies Cerulean uses to develop nanopharmaceuticals. Cyclodextrin Nanoparticle Technology (CDP), which Cerulean licensed out of Cal Tech, is furthest along. Early studies showed promising clinical activity against difficult-to-treat diseases like non-small-cell lung cancer and pancreatic cancer. Phase 2a clinical trials have just begun recruiting patients with advanced solid tumors. The second technology, Polymeric Nanoparticle Technology (PNP) was developed in-house based on an earlier technology licensed from MIT. Unlike most nanomedicine formulations (including CDP), PNP does not attach a separate targeting entity to the nanoparticle. Instead the particle’s design is optimized to directly target the organ or tumor type of interest. Both technologies feature sophisticated chemistry which gives designers the ability to control the release of drugs conjugated to a polymer backbone. Pharmacokinetics can thus be adjusted to deliver high doses while minimizing side effects. The techniques can be applied to many different types of drugs, including both small molecules and more challenging peptides or si-RNAs. Preliminary studies suggest that docetaxel, a very commonly used chemotherapy, accumulates in tumors at 20x the conventional rate when delivered via PNP.
Nanosphere CEO William Moffitt was the diagnostician in the life sciences session. Nanosphere’s detection products stem from Chad Mirkin’s work at Northwestern University. The company has raised over $200M in public and private funds, including early support from both NIH and NSF, and went public in 2007. Their technologies can be applied for direct genomic detection or ultrasensitive detection of proteins. It is being developed for point-of-use diagnostics, in hospitals, doctors’ offices, etc. Current technology for genomic detection, based on the polymerase chain reaction (PCR) is too sophisticated and expensive for many potential sites. It is only available in about 10% of U.S. hospitals. Nanosphere believes their tools can be used much more widely. Currently the most expensive consumable part of their Verigene system is the plastic test cartridge. That cost will go down to less than the price of a latte once production quantities are scaled up. Two application examples Mr. Moffitt discussed are testing a patient’s ability to metabolize the anticlotting drug Plavix (which is ineffective for 30% of patients) and early detection of bloodstream infections. Nanosphere’s instruments cut test time from 3 days to a few hours, and they can pinpoint the specific agent of infection. This could significantly reduce sepsis and death due to hospital-acquired infections. Mr. Moffitt considers PCR and ELISA (Enzyme-linked immunosorbent assay) to be the two most important medical diagnostic developments of the last half-century. Nanosphere’s products and similar technologies can improve on both of these workhorses, with better performance, higher speed, and ultimately lower cost.
The advance nanomaterials session included Professor Zhong Lin Wang of Georgia Institute of Technology; Dr. VJ Sahi, Vice President of Government Affairs for Nanosys; XinRay Systems CEO Dr. Moritz Beckmann; and our good friend Terry Medley, Global Director of Corporate Regulatory Affairs for Dupont. Most of you have probably seen beautiful pictures of zinc oxide nanoflowers, springs, and ribbons from Z.L. Wang’s group. On Friday, Dr. Wang emphasized his group’s work on exploiting the piezoelectric properties of zinc oxide to convert nanoscale motion into useable energy. This work complements the better-known efforts to address our energy problems with nano-enhanced photovoltaic or thermoelectric devices. They have learned to transfer arrays of nanogenerators onto cheap, flexible substrates, and can power a 20 mW LED lamp with a 1 square centimeter array. The ultimate goal is to self-power small networked sensors or similar devices by scavenging mechanical energy from the environment.
Dr. Sahi told us how Nanosys, one of the earliest companies formed to commercialize nanotechnology, has evolved during the first decade of the NNI. Founder Larry Bock’s original vision was to consolidate intellectual property rights related to nanotechnology for electronics and energy applications, and incubate good product ideas. Until 2007, the company looked at platform approaches and considered a wide variety of applications, based on a portfolio of issued or applied-for patents that now exceeds 750. They have since narrowed their focus somewhat. Now they are working in four areas: LED lighting, Lithium ion batteries, solar energy, and flash memory. Nanosys’ lighting technologies include QuantumRail, which uses quantum dots as downconverters to generate a full range of colors from conventional gallium nitride LEDs. LG had a cellphone using this technology for display backlighting at the last Consumer Electronics Show, and will show an expanded range of products at January’s CES. Samsung is also licensing Nanosys technology for lighting. In the battery space, they are trying to find a way to really accelerate the yearly improvement in storage capacity. The battery industry has been delivering 3-5% more capacity a year, but that won’t get us where we need to be for large-scale grid storage or long-range electric vehicles any time soon. So they are working on a composite anode which combines the high capacity of silicon with graphite’s ability to expand and contract without damage during charge/discharge cycles. Some competitors’ anodes lose half their capacity in the first cycle. Preliminary results for the composite anodes are promising, with 7% loss on the first cycle and less than 20% after 1000 cycles in a half-cell.
Dr. Beckmann described XinRay’s use of carbon nanotubes as cold cathode electron sources in a new generation of imaging devices, with applications in both medicine and homeland security. XinRay uses carbon-nanotube-based electron sources to stimulate x-ray production in systems for tomosynthesis, which he called “a poor man’s computed tomography.” Current tomosynthesis systems move a localized source of x-rays to assemble multiple, high-resolution image slices into a composite image with limited 3-D information. By replacing the localized source with a distributed source which can be electrically steered, XinRay can cut the scan time by a factor of 5-10 while reducing image blur. Applications include image guidance for radiation therapy and baggage screening, where XinRay’s system could greatly reduce the need for manual inspection.
Terry Medley closed the materials session with an overview of Dupont’s interests in nanotechnology. As you know, Dupont was an early entrant to the field both in the R&D lab and as a leader in occupational health and safety. Mr. Medley broke down the company’s interest in nanotechnology into 4 areas – nanoscale science and engineering research, nanostructured materials, coatings, and nanoparticles. He described his company’s attitude towards NNI Goal 4 (Responsible Development) as basically unchanged since 2005. That’s when Chad Halliday, who was then CEO, wrote and op-ed for the Wall Street Journal entitled “Let’s get nanotech right.” Of course Terry himself has contributed greatly to that goal, through his work at Dupont, their partnership with Environmental Defense in developing a framework for evaluating the risk profile of a nanomaterial, and his role in the OECD Working Party on Manufactured Nanomaterials’ ongoing work program.
While it was both enjoyable and gratifying to hear all these speakers describe the NNI’s successes to date and how it has nurtured the nanotechnology industry through its infancy, for sheer excitement nothing could compete with the closing, forward-looking session. The four speakers each built a visionary presentation around serious nanoscience. Professor Nathan (Nate) Lewis of Cal Tech started the “Future of Nanotechnology Innovation” session with a talk on energy. Professor Andre Nel of UCLA followed with thoughts on high throughput methods for the toxicology measurements central to EHS studies. Dr. Stan Williams of Hewlett-Packard speculated about fundamentally new electronic devices and computer technology. Finally, Rutledge Ellis-Behnke (MIT and the University of Heidelberg) showed some of the exciting frontiers in nanomedicine.
Professor Nel led off, telling how he is constructing a toolbox to speed the discovery of better, safer engineered nanomaterials. To set the stage for this effort, he reminded us that nanotechnology is not currently known to be responsible for any human disease or serious environmental impact. But… there is definitive evidence of hazard – i.e., the ability to cause harm – for some particular nanomaterials. And the real problem is that for nanomaterials overall we have very incomplete knowledge of hazard. Since the characterization of hazard is essential to robust risk management, it is important to find efficient ways to add make that knowledge more complete. Dr. Nel and his colleagues think they can do this by using the nano-bio interface as a discovery tool. They can perform up to 10,000 observations per day. It is an approach that is similar to how the pharmaceutical industry uses in vitro methods to discover candidate therapeutic agents. If you are interested in more details, Dr. Nel reviewed the subject for the Nano2 report.
Professor Lewis’ talk covered the prospects for various types of solar energy. Energy absorption and conversion processes occur at the nanoscale, so using nanotechnology to manipulate them is a natural. By “fooling” nanoparticle assemblages into behaving like single crystals, for example, companies like Solexant and NanoSolar are already printing thin film photovoltaics. And in the laboratory, multi-junction nanodevices have exceeded the maximum efficiency thermodynamics allows for single-junction cells without concentrators. But those achievements are not enough. Photovoltaics presently only provide 1/1000th of a Terawatt of power to the electricity grid worldwide. On the average, oil, coal, and gas-driven plants generate 1500 times as much, or 1.5 Terawatts. Expanding beyond the electricity sector, biomass (which is solar-fed fuel) supplies 1.4TW of power. Meanwhile fossil fuels supply an average of 11 Terawatts. Even with vast scaleup, PV solar will never become a primary energy source without massive storage capacity – but all the batteries that have ever been made would only store enough energy to absorb the grid’s full output for 10 minutes. These kind of general arguments led Dr. Lewis to look for a different way to use the sun’s light to satisfy our energy needs. The idea, which he is pursuing as the director of the Fuels from Sunlight Innovation Hub which Secretary Chu spoke of earlier, is to borrow from and improve on photosynthesis, which is the way nature captures solar energy. But instead of converting light to carbohydrates, as plants do, the Hub researchers want to convert light directly in to hydrocarbon fuels. Dr. Lewis guaranteed us that they will deliver a working prototype of such an artificial photosynthesis system within 5 years.
Before laying out his vision for the future of computation, Dr. Williams, who is now a Senior Fellow at Hewlett-Packard Laboratories, gave some personal reflections on the beginnings of the NNI. Physical science funding was moribund, he said, in 1998. Grants for nanoscale science had less than a 10% chance of being accepted, and the community was getting desperate. This was the backdrop against which Mike Roco sketched his idea of a national initiative in the nanosciences. Dr. Williams joined Dr. Roco and Dr. Paul Alivisatos in putting together the 1999 report, “Nanotechnology Research Directions”, with significant contributions from Professor George Whitesides. Tom Kalil liked the idea and became its champion within the Clinton Whitehouse, leading to the proposal that nanotech funding should be doubled immediately, and then doubled again, and again over the next decade. Dr. Williams thinks the original “Research Directions” was an accurate, if very optimistic, reflection of the ideas then in the community. And he thinks we have delivered well on these ideas, though perhaps less so in theoretical advances than in experiments, building great facilities, and stimulating an influx of engaged students. At HP Laboratories, Dr. Williams’ Quantum Science Research group represented one half of one percent of the total effort in 2000. Its successor, the Quantum Systems Lab, now represents 18%, and his personal ambition is for it to contribute directly to 20% of HP’s revenue. More than 70 scientists who received their Ph.D.s for NNI-supported research have come to work at QSL as postdocs or staff members. They collaborate with 20+ universities and with NNI centers funded by NIST, DOE, NSF, and others. QSL’s work is divided into three major initiatives, one of which has already developed products. These are sensing solutions, optical switching, and memristor-based electronics. Memristors are a fundamentally new electronic circuit element which can be used for both digital memory and logic devices. Or, they can be operated as analog devices that mimic the behavior of synapses in the brain. HP is making 300 mm wafers covered with memristors now, and interfacing them to conventional CMOS electronics. Since memristors lend themselves to a layered, 3D construction, very dense, fast, low-power computing devices seem within reach. If the scaling goes as planned, the ever-optimistic Dr. Williams predicts that we will have exaflop computers (10^18 floating point operations per second) by 2020, along with networks of a billion sensors. Yet another decade down the line, with memristors operating in analog synaptic mode, he is predicting 10^21 FLOPs and trillion-sensor networks.
The last speaker of the Summit, Dr. Ellis-Behnke looked back well beyond the start of the NNI to set the context for his own predictions of the future. Today, three things you never want to hear from your doctor are:
1. you’re going blind,
2. you’re losing your mind, or
3. you have cancer.
One hundred years ago, it would have been just as devastating to hear that
4. you had an infection.
Can nanotechnology do for the first three list items what antibiotics did for #4? Dr. Ellis-Behnke thinks so. As an example of how, he showed some spectacular work with self-assembled peptide (SAP) materials. In one set of experiments which he calls NanoNeuroKnitting, Dr. Behnke showed a few years ago that surgically blinded hamsters can regenerate the optic nerve connections necessary for sight, if SAP is inserted into the damaged area to form a scaffolding for the nerves along which to grow. In an update to that work, he showed us that by adding another material that disassembles the scaffolding at the right time in the healing process, the results improve dramatically. This same SAP material can be used to quickly stop blood flow from a traumatic injury or an incision. He even showed videos of brain surgery performed through a transparent SAP layer. Since this material works by containing blood but does not cause it to clot, they have found that a very small amount added to banked blood preserves it for 28 days at room temperature. To further demonstrate the versatility of these materials, he showed that they can be used to form an isolation barrier around cancer cells which prevents them from dividing and so halts tumor growth. Dr. Ellis-Behnke noted that manufacturing, and distributing, and regulating medical products which are so radical will be fraught with bottlenecks. If we work through them, items 1, 2, and 3 may soon disappear from the list.
I hope you have enjoyed the summary.
Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
Posted on December 17th, 2010 in Uncategorized | No Comments »
I enjoyed my time in DC at the National Nanotechnology at Ten: Nanotechnology Innovation Summit last week. I am very excited in regard to the next 10 years of Nanotechnology. Great to see our Nanotechnology Community friends such as:
Dr. Mike Roco, NSF; Doug Jamison, H&H; Peter Antoinette, Nanocomp; Piotr Grodzinski, NCI; Angela Belcher, MIT; Jeff Morse, National Nanomanufacturing Network; Kitu Bindra, Envia Systems; Alexei Andreev, H&H; George Allen, Former Senator of VA; Jim Mason, The ONI; Lynn Bergeson, B&C; Seth Coe-Sullivan, QD Vision; Travis Earles, White House OSTP; Charles Geraci, NIOSH; Bart Gordon, US House of Representatives, TN; Tom Kalil, White House OSTP; Terry Medley, Dupont; William Moffitt, Nanosphere; Matthew Nordan, Venrock; Mark Ratner, Northwestern University; Misti Ushio, H&H; Brent Segal, Lockheed Martin; Lloyd Whitman, NIST; Dave Arthur, SWeNT; Anita Balachandra, TechVision21; Craig Bandes, Pixelligent; Keith Blakely, NanoMech; Harry Bushong, nanoTox; Charlie Gause, Luna; Jim Hussey, NanoInk; Leonard Poveromo, Northrop Grumman; Chuck Van Fleet, Swan Chemical and Marlowe Epstein, NNCO
Here is a summary of the Nanotechnology Innovation Summit.
Last Thursday and Friday, December 9th & 10th, we attended the Nanotechnology Innovation Summit organized by our friends at NSTI on behalf of the agencies participating in the National Nanotechnology Initiative. The event, marking the 10th anniversary of the interagency Federal initiative, took place in National Harbor just south of Washington, DC. Attendees at a preliminary workshop held on Wednesday heard directly from program managers at numerous funding agencies, who described their research priorities in the context of the NNI Strategic Plan. As regular readers of this newsletter are aware a draft of the updated plan was posted on strategy.nano.gov for public comment throughout November. Since that plan calls for increased emphasis on goal-oriented research driven by national priorities, technology transfer, and support for commercialization activities, it is appropriate that “innovation” served as the theme for the anniversary workshop.
Travis Earles, Assistant Director of Nanotechnology in the White House Office of Science and Technology Policy, served as Master of Ceremonies for the Summit. You can read Travis’ own take on the proceedings (co-written with OSTP Deputy Director for Policy Tom Kalil) at the OSTP blog. Thursday opened with a keynote panel featuring a rare confluence of Presidential Science Advisors – Neil Lane (Clinton), John Marburger (Bush) and John Holdren (Obama) – giving a high-level Administration perspective. The Congressional point of view was presented by Bart Gordon, soon to retire as Representative from Tennessee and Chair of the House Science Committee, in Friday’s keynote address.
With Tom Kalil moderating, the Science Advisors (who also serve as OSTP Directors) each gave their perspective on the origins of the NNI and its course so far. Lane noted that what President Clinton liked to refer to as “my tiny little initiative” started in a time of budget surpluses and garnered rare bipartisan support. He is optimistic about the future of the initiative and remains convinced, as he told the House Science Committee when he was Director of the National Science Foundation, that nanoscale science and engineering is a key field for the future, but noted that we are headed for some tough budget years. Nevertheless the NNI’s budget growth from $495M in 2001 to an estimated $1.6B in 2011 is remarkable. Marburger noted that OSTP is lucky to have critical personnel just below the political appointee level who provide continuity across administrations. The success of the NNI through two presidential transitions is a testament to their value. He pointed out that we have known that interesting things happen at the nanoscale for a long time – that’s nature – but that the National Nanotechnology Initiative was founded to take advantage of emerging abilities to do something about it. The tools that enable this are high tech, but not particularly expensive, so the rise of nanotechnology programs around the world is not at all surprising. Marburger also noted that the planners of the NNI had paid attention to health, safety, and environmental issues from the very beginning, but that this has not been enough to satisfy the critics. He advocated for continued attention to the EHS issue, international competitiveness, and the difficulty of training skilled researchers and workers in a highly interdisciplinary field. Holdren expressed strong appreciation for his predecessor’s work in putting the NNI on solid footings, and listed five points that summarize the Obama Administration’s emphasis for the Initiative:
1. The NNI should continue to be a high priority for R&D agencies, as reflected in the annual Budget Memo he co-authors with the Director of the Office of Management and Budget, since nanotechnology is expected to play a vital role in economic growth and job creation.
2. Agencies should continue to support nanoscale science, engineering, and technology broadly but should increase activities supporting the NNI Signature Initiatives (to date, Nanotechnology for Solar Energy Collection and Conversion; Sustainable Nanomanufacturing – Creating the Industries of the Future; and Nanoelectronics for 2020 and Beyond, with the identification of new Signature Initiatives and establishment of supporting public-private partnerships called for in the draft Strategic Plan).
3. Nanotechnology research should support existing grand challenges in the research community, for example in sustainable energy or cancer therapeutics.
4. The emphasis on responsible development, as reflected by the growing funding for EHS research, will continue.
5. Concrete recommendations from PCAST for greater emphasis on innovation should be heeded through increased use of public-private partnerships and stronger technology transfer and commercialization efforts.
Following a break to explore the accompanying Innovation Showcase, leading figures from the business world discussed national and global issues driving the need for nanotechnology innovation. Norm Augustine, former Chairman and CEO of Lockheed Martin, noted that the “Gathering Storm” of international competitors identified in 2007 by a committee he chaired for the National Academies has not dissipated. In fact, a recent update to that report suggests we are losing ground. He noted that innovators do not respect boundaries, and that we continue to have a lot of good innovators in the United States, but fears that we are benefiting from our prior investments in educating scientists and engineers while falling behind in new investments. He urged us all to pay attention to how Congress treats the COMPETES Act in the next few years, closing with a quote from Winston Churchill: “You can always depend on Americans to do the right thing. After they’ve done everything else.” Jim Rudd of GE Global Research, while noting the many technological innovations GE has made based on discoveries here in the U.S., pointed out that the company now has 6 global centers in the research division, four of which are overseas (in China, Germany, India, and Brazil). GE does have over 100 research employees investing in nanoparticles, nanostructured materials, and coatings for applications like shedding ice from aircraft engines, improving heat transfer in steam turbines, and developing enhanced contrast agents for magnetic resonance imaging. Former Intel CEI Craig Barrett spoke about three main issues. He discussed the Nanoelectronics Research Initiative, perhaps the premiere example of an NNI-affiliated public private partnership, at some length. While recent generations of semiconductor electronics, from Intel and its competitors, include substantial amounts of evolutionary nanotechnology, the NRI is focused on revolutionary electronic devices and architectures to take the industry beyond the predicted end-of-life for CMOS technology, which he said is now expected to provide perhaps 12-15 more years of Moore’s Law improvements. On the policy side of things, Barrett echoed previous speakers concerns regarding education – he is now spearheading an effort called Change the Equation which is getting corporate America involved in STEM education. He pointed out that Intel’s venture capital arm, which he called the world’s biggest high tech VC supplier, used to make 90% of its investments in the U.S. That number is now down to about 50%, with the rest going to Asia. He also can’t imagine that the wafer fabs for future generations of semiconductors will be built in the U.S. much longer, given the substantial disincentives in tax and immigration policy relative to other countries.
The morning session closed with reports from three leaders of the nanotechnology investment community who are well known to NanoBusiness Alliance members – Harris and Harris’ Doug Jamison, Venrock’s Matthew Nordan, and Aymeric Sallin of NanoDimension. Doug outlined H&H’s long-term commitment to nano and microsystems technology, and discussed the firm’s pipeline of companies at various stages of maturity. He pointed out that the successes so far have come in extremely difficult times, with opportunities for exits all but non-existent for about five years. Doug noted the importance of partnerships for early-stage firms, both with larger, established companies and with research agencies. H&H has invested about $125M in their portfolio companies, which have attracted about $1.5 B in venture capital overall. While the $80M these companies have received in federal funds seems small in comparison, it is an important leveraging tool. Matt discussed investment in nanotechnology from his current perspective and in terms of his prior role as a founder of Lux Research. He pointed out the loss of 5.5 million U.S. manufacturing jobs over the last decade, and called science and technology innovation the only tool left in the U.S. competitiveness toolkit. While Venrock has a much broader focus than Lux – only Nanosys is an “obvious” nanocompany – other portfolio companies, for example several in the energy space, rely on nanomaterials and technology. Aymeric’s company invests exclusively in nano, and covers the field broadly. He claimed they screened 1700 companies in the past year, and took a more serious look at 173. Virtually all of their companies received NNI support in one form or another. Like H&H, their portfolio includes a mix of company maturities. As an example of a later stage company, he noted that Soladigm (which manufactures green building materials like switchable clear/tinted glass) is now hiring 300-400 people to ramp up their manufacturing.
Thursday afternoon featured two more technical sessions and another chance to visit companies displaying their wares at the Showcase. We heard from Northwestern University Professor and molecular electronics pioneer Mark Ratner, from IBM’s Tom Theis, and from Dawn Bonnell, Director of the Nano/Bio Interface Center at the University of Pennsylvania. Dr. Ratner pointed that nature’s solar energy conversion process, photosynthesis, utilizes aligned nanostructures and discussed synthetic analogues. He also discussed application in health care, especially diagnostics, and security. A long-time advocate for education and the development of young researchers, Mark pointed out that nanotech is still a young field, so it is especially important that we don’t just look to financials as a measure of success. We have real companies doing real things, and real students speaking the language. Quoting Thoreau, he concluded, “There is more day to dawn. The sun is but a morning star.” Dr. Theis discussed some of IBM’s most recent lab accomplishments in the realm of devices and systems for future generations of computers, including optical devices fabricated out of silicon and fully integrated with CMOS processing techniques and small, fast transistors made with carbon nanotubes or graphene. He noted that, despite their world-class research strengths, IBM can’t go it alone and relies on partnerships like the NRI to overcome the full set of barriers which must be overcome to deploy new technologies in the semiconductor industry. In addition to discussing why the “next switch” must not just be small but must be able to switch at lower voltages than scaled CMOS, he made an interesting remark about NSF’s new solicitation for proposals as part of the Nanoelectronics for 2020 and Beyond Signature Initiative. There are three eligible topics – new materials, new state variables, and new architectures or computing paradigms. Dr. Theis noted that by requiring proposals to address not just one of these topics but at least two, NSF was stimulating the kind of cross-disciplinary partnerships that are needed to identify manufacturable solutions from among the many things that physics allows. Dr. Bonnell was a participant in the “Nano2″ study which we wrote about a few weeks ago, a broad survey of nano research in the U.S. and internationally. She noted that, while there is a lot of continuity in topics and programs since the start of the NNI, there are several current hot topics that were not foreseen. Two examples are graphene and nanoplasmonics. From her own Center’s work, she highlighted carbon nanotube-based sensors and cancer biomarkers. Finally, Dr. Bonnell noted that we must continue to evolve versions of our nano instruments that are capable of making measurements in manufacturing environments, as opposed to the research environments from which they generally come.
There were two more presentations from high-ranking Federal officials Thursday afternoon – Secretary of Energy Steven Chu, and Leo Christodoulou, Director of the Defense Sciences Office of DARPA. Secretary Chu summarized DOE’s plans to “Transform the Energy Landscape” before giving numerous examples of DOE-funded research into basic phenomena of importance for solar energy conversion, energy storage, efficient separation and capture of carbon dioxide or other greenhouse gases, and improved building technologies such as LED lighting. He discussed the Energy Innovation Hub program, sometimes called “Bell Lab-lets”, using the example of the Fuels from Sunlight Hub (Caltech/Lawrence Berkeley National Laboratory) with its ambitious goal of finding an artificial way to efficiently convert light and water to oxygen and hydrogen and then catalyze the production of a hydrocarbon fuel, mimicking photosynthesis but with much higher efficiency and an end product tailored to our fuel delivery systems. Dr. Chu concluded by saying that we have a lot of technologies in place as a result of research to date, but need new breakthroughs to meet our goals. Dr. Christodoulou spoke mostly about DARPA’s general approach to innovation – DARPA is not afraid to fail – although he noted that in briefing Deputy Director Ken Gabriel (who was originally scheduled to speak) for this meeting, he came up with plenty of impressive DARPA-funded “topdown’ nanotechnology. Examples include a tour-de-force maskless nanowriter, tip-based nanofabrication work, and functional interfaces. In contrast, he noted that the agency’s Blue Angel vaccine program is producing 16 million doses of vaccine per month, using tobacco as the bottom-up biofactory (a sort of surrogate nanowriter). He believes that if the 21st century is, as some have suggested, going to be the age of the control and manipulation of matter, more of our research will have to take high throughput bottom-up approaches.
Nanobusiness leaders rounded out the day in sessions devoted to innovations in energy technology, electronics, and manufacturing. A123 co-founder and MIT Professor Yet-Ming Chiang pointed out that batteries were probably not a significant factor in the initial NNI plans, but are now a big feature of the nano landscape. Transportation, storage of energy on the electrical grid, and consumer or industrial uses are all major application drivers of continued R&D. Dr. Chiang noted that his company initially intended to focus on another technology, but changed its course after observing fast full discharge behavior in some research cells. They’ve now built a business on the excellent discharge characteristics and cycle lifetimes of materials similar to those research cells, and continuing fundamental research promises further improvements. The company has some offshore manufacturing, but has invested heavily (with federal support) in new domestic facilities for production of both cells and battery packs. They now have over 700,000 square feet of factory space in Michigan. Four electric cars are using A123 batteries (the Fisker Karma, Hymotion plug-in converted Prius, and two vehicles built by Shanghai Automotive Industry Corp. for the domestic Chinese market). Navistar will soon deliver an all-electric delivery van for FedEx using their batteries, and A123-powered hybrid buses have already accumulated over 60,000 road miles. On the storage front, Southern California Edison will use A123 product in the world’s largest Lithium-Ion battery installation, at the Tehachapi Wind Project. Federal support has been very significant for the company, from its first DOE-SBIR grant through $100M of Automotive Battery Consortium funding and $240M of American Recovery and Reinvestment Act funds.
Seth Coe-Sullivan of QD Vision described his company’s two quantum-dot-based product lines: microdisplays, and LED lighting. Both were available for inspection at the Product Showcase, although the displays haven’t yet been released commercially. Since 22% of our nation’s electricity is used for lighting, and another 3% for displays, QD Vision’s approach has set out to decrease energy usage while improving performance. Their microdisplays are low power yet display a larger gamut of color than conventional phosphors, while their lighting products allow LED manufacturers to efficiently shift the spectrum of their emitters to provide perceived color quality comparable to traditional incandescent lamps. The Nexxus R30 LED lamp, which uses QD Vision’s technology, has a color temperature of 2700K and and outputs over 60 lumens per watt. The next-best available lamp with comparable color quality only put out about 40 lumens per watt. Seth discussed the importance of collaborating with established partners in your target industry. He also pointed out that his company is very committed to delivering nanotechnology safely throughout their products lifecycle, including disposal. They have worked with NIOSH, and are focusing research on lead- and cadmium-free quantum dots. As far as funding goes, QD Vision has received about two dollars in venture capital for every dollar of federal funding.
Damoder Reddy discussed Solexant and its ultrathin, roll-to-roll printed photovoltaic cells. The company, founded in 2006, has a small plant operating in the Bay Area and is constructing a 100MW capacity line in Oregon. Their work spun out of Dr. Paul Alivisatos’ group at Berkeley. While the current cells use Cadmium Telluride-bearing inks, they are developing a Cadmium-free version and hope to transition to that technology in about three years.
Brent Segal of Lockheed Martin Nanosystems described the fast, large, non-volatile memory technology originally developed at Nantero. Lockheed Martin bought the government systems division of Nantero a few years ago, with the original company focusing on commercial uses. Brent described the company’s “$31.5 Million journey” from an idea to a test board which flew on the Space Shuttle’s Hubble Repair Mission. Nantero’s success had an element of serendipity in it, since radiation hardness – considered a key feature for NASA and military applications – was not one of their original design goals. They continue to scale their chips, with a 64Mb generation coming soon and a 2Gb chip on the drawing boards. Brent is also an active participant in several nanotechnology standards development efforts, and he made a pitch for further participation in both standards development and public-private partnerships.
Peter Antoinette of Nanocomp Technologies says his company is delivering on the promise of scale. They are making carbon-nanotube-based yarns and sheets at a rate of several kilometers per week, while building next-generation facilities to further increase their output. The company has important partnerships with Rochester Institute of Technology and UMass-Lowell, and has worked closely with NIOSH and the EPA. Their CNT yarns have been incorporated into lightweight coaxial cables that are fully qualified for spaceflight, and their sheets have been used for EMI shielding on planes and satellites. One potential commercial application is in the entertainment wiring on the Boeing 7×7. Since this is a non-critical system, the qualification process is a relatively short 18 months or so. Peter noted that his is an intensely competitive field, with significant foreign competitors. So far, inflows of capital and talent have been sufficient to keep Nanocomp ahead.
S.V. Sreenivasan, Chief Technical Officer of Molecular Imprints and Professor at the University of Texas at Austin, described his company’s work in the memory and magnetic storage arenas. Beginning with DARPA funding in the mid-90s, they have developed lithographic processes with 1.5 nanometer critical dimension uniformity and 2.0 nanometer roughness control. A major application is in hard disk drives, where manufacturers will need patterned media within 18 months to stay on their continually improving capacity curve. MI’s 3rd generation of tools have the required specs, with the ability to create 15 nanometer pillars over large disks at a cost of ~ 35 cents per disk. They have also shipped a tool to an Asian NRAM manufacturer which can process ten 300 millimeter wafers per hour, for use in memory chips with feature sizes < 25 nanometers.
Dr. Angela Belcher was the final speaker on Thursday. As many of you know, in addition to serving as Germehausen Professor of Materials Science and Engineering and Biological Engineering at MIT, Angie is a co-founder of not one but two nanotech companies – Cambrios Technologies and Siluria. Dr. Belcher discussed these companies’ work to commercialize her research on biomaterials, virus-guided self-assembly, etc, but her most telling remark may have been this: the beginning of NNI coincides pretty directly with the beginning of her research career. She never knew a research landscape without an NNI, and finds it difficult to imagine. Dr. Belcher is truly one of the first of those new-generation innovative interdisciplinary thinkers that earlier speakers pointed to as among the most valuable products of the Initiative. With that thought, we’ll close for today. A discussion of the Friday activities at the Nanotechnology Innovation Summit will be forthcoming. In ten years, there has truly been a lot of progress to cover!
Last week’s conference was fabulous. If you have any additional questions, please feel free to contact me at firstname.lastname@example.org.
Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
Posted on December 13th, 2010 in Uncategorized | 1 Comment »
The NanoBusiness Alliance is very committed to providing relevant Environmental, Health and Safety information to our Nanotechnology Community. Today, we continue our interview series with Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C. (B&C). Lynn is one of America’s top EH&S practitioners and is the Chairman of the NanoBusiness Alliance’s EHS Committee. B&C is a Washington, D.C. law firm concentrating on conventional and engineered nanoscale chemical, pesticide, and other specialty chemical product approval, regulation, litigation, and associated business issues. Ms. Bergeson is also Principal of The Acta Group, L.L.C. and The Acta Group EU, Ltd, B&C’s consulting affiliates, with offices in Washington, D.C. and Manchester, U.K., respectively. Ms. Bergeson counsels clients on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, and related legal and regulatory aspects of conventional and nanoscale chemical regulatory programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, and on issues pertinent to nanotechnology and other emerging transformative technologies.
Ms. Bergeson lectures and writes frequently on a wide range of chemical regulatory matters. She serves on the Editorial Board of Nanotechnology Law and Business, 2008–; Press Advisory Board of Environmental Law Institute’s (ELI) Environmental Law Reporter, 2007–; Editorial Board of ELI’s The Environmental Forum, 2004–; Pesticide & Toxic Chemical News, 2002–; EPA Administrative Law Reporter, 1996–; Environmental Quality Management, 2002–; Chemical Processing Magazine, 2002–; and Pollution Engineering, 1990–, among other publications. Ms. Bergeson is a member of The District of Columbia Bar; Bar Association of the District of Columbia; American Bar Association (Section of Environment, Energy, and Resources); Women’s Bar Association of the District of Columbia; and the Women’s Council on Energy and the Environment. Ms. Bergeson is a graduate of Michigan State University (B.A., magna cum laude), and the Columbus School of Law, Catholic University of America, where she was a member of the Law Review. She is admitted to the bar of the District of Columbia and several federal circuit courts.
In this interview, we speak with Lynn about a wide range of issues related to nanotech Environmental, Health and Safety (EHS). We hope you enjoy the interview. – Steve Waite
SW: It is a pleasure speaking with you today, Lynn. There has been a lot of work in nanotech EHS over the past decade. What are the major things we have learned?
LB: Steve, thank you for speaking with me. We have learned quite a lot. First, we know that nanotechnology covers a dazzling array of technologies that are applicable to a similarly broad range of industry sectors. We know these applications are beneficial, and require nurturing. We know also that much work remains to be done to ensure consumer confidence and demonstrate effective regulatory and governance oversight.
SW: What are the hot nano EHS topics today?
LB: There are several big issues. The most global, and vexing, has to do with defining terms. Establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes is a priority. This is especially true given the growing number of regulatory initiatives that are emerging in the U.S., European Union (EU), and elsewhere. Here in the U.S., the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) is working on three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of nanoscale materials. These are a Section 4 request for testing, a Section 5 categorical significant new use rule (SNUR), and a Section 8 request for information. EPA’s Office of Pesticide Programs (OPP) is also working on a policy under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will apply to nanopesticides. If issued, it too will have a significant impact on nanoscale materials used in pesticide products.
SW: EHS testing has become more difficult over the years with greater restrictions on using animals and humans for tests. How are companies coping with these restrictions?
LB: Companies with which I work appreciate the limitations on animal testing and the growing restrictions on testing involving humans. That said, in vivo testing will continue to be necessary if we are to develop credible scientific evidence that helps identify with precision the circumstances and types of materials that might pose risks. While there are a growing number of alternative testing methodologies and strategies that nanomaterial manufacturers and related others may use to demonstrate the safety and efficacy of their nano innovations, these alternatives are in their infancy. For example, in vitro tests are used with bulk materials to predict toxicity to humans. Such tests must be carefully calibrated to be useful, and the utility and limitations of such testing must be known to ensure test results are meaningful.
SW: Let’s talk about the various regulatory agencies for a moment. What are the major EHS initiatives at the EPA currently?
LB: As noted, EPA is most active in regulating new nanoscale chemical substances under TSCA. EPA has reviewed over 100 nanoscale substances and has obtained a solid and growing knowledge of a range of nanoscale materials. EPA is now working on TSCA Sections 4, 5, and 8 rulemakings. EPA’s pesticide office is less far along, and is focusing on nanoscale materials used in biocide applications. EPA is developing an “interpretation” of FIFRA Section 6(a)(2) (adverse effects) reporting pertinent to nanoscale materials known to be included in pesticide products, and reportedly working on FIFRA Section 3 data call-ins for certain substances. All of these initiatives are important.
At the state level, all eyes are on California. The Department of Toxic Substances Control’s (DTSC) data call-ins on nanoscale materials are important developments as are the Office of Environmental Health Hazard Assessment (OEHHA) Green Chemistry Hazard Traits Endpoints and DTSC’s implementation of the Green Chemistry Initiative as these developments relate to nanoscale materials.
SW: What are the significant EHS initiatives at the FDA today?
LB: The U.S. Food and Drug Administration (FDA) seem to be moving very deliberately. The Task Force it set up made a number of recommendations in 2007 that the Agency is still discussing in various public venues and fora such as the public meeting it held on September 23, 2010, to obtain information and opinions on characterization, manufacturing, and biocompatibility of nanomaterials. FDA is using such information, and the results of testing it conducts in Arkansas and that the Nanotechnology Characterization Laboratory of the National Cancer Institute (NCI) conducts in Maryland in large part to answer the basic regulatory question it must first address: When is a nanomaterial the “same” as its macro-particle counterpart? The answer to that question will have a big impact on the classification of products and will determine the standards a manufacturer must meet to obtain approval or clearance, as well as the data to support submissions for that purpose, for types of products, including generic drugs, indirect food additives, food contact substances, dietary new ingredients, and substantially equivalent medical devices. Where the issue is not a claim that the material is the “same” as in a predicate product, FDA will have to decide the proof needed to meet the applicable regulatory standard for that class of product, and it is doing so, to date, on an ad hoc basis, rather than by regulation or guidance.
SW: What are the major nanotech EHS initiatives we are seeing currently in the EU?
LB: In the EU, the European Chemicals Agency’s (ECHA) ongoing work under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), in particular the REACH Implementation Projects (RIP) on nanomaterials, is important in the regulation of nanoscale materials, as is developing guidance under the Classification, Labeling, and Packaging regulation, EC No. 1272/2008. Finally, the EU implementation of the food and cosmetics labeling regulation is important, and will have precedent setting implications.
SW: Are we seeing greater collaboration among the various regulatory authorities inside and outside the U.S. with respect to nanotech EHS?
LB: Yes. Domestically, federal agencies coordinate through the National Nanotechnology Initiative (NNI) under the management framework of the National Science and Technology Council (NSTC). The Nanoscale Science Engineering and Technology (NSET) Subcommittee of the NSTC coordinates planning, budgeting, and program implementation. In addition, the White House Policy Coordination Group is a policy committee that was formed to address “emergent technologies,” including nanotechnology. This group also coordinates across federal agencies. Finally, there are agency-specific groups embedded in specific federal agencies, including EPA and FDA, focused on ensuring consistency within federal agencies.
Internationally, the Organization for Economic Cooperation and Development (OECD) has been devoted to fostering harmony on multiple issues pertinent to nanotechnology. The Working Party on Manufactured Nanomaterials and Working Party on Nanotechnology were created several years ago and are devoted to developing a shared view on technical and policy issues, and leveraging internal resources in a way that maximizes OECD member countries’ and others’ investments in nanotechnology.
SW: What are the typical kinds of mistakes companies make with regard to nanotech EHS?
LB: Nano companies are in many respects no different than other more traditional businesses. Prudent business planning and effective product stewardship goes a long way. A commitment to be responsible and compliant with all applicable laws and regulations is also a must. Importantly, however, nano businesses must grow and flourish in a fluid regulatory context where standards and courses of business conduct are evolving. This definitional and regulatory fluidity invites uncertainty that is typically unnerving to management, investors, insurers, and business owners. As a business owner, I can relate and sympathize. It is all the more reason companies need to plan smart, get really good legal counsel, and monitor evolving domestic and international regulations and business standards carefully.
One of the benefits of NanoBusiness Alliance membership is being kept aware of these evolving standards and practices, and being offered an opportunity to discuss the cutting edge business issues that are of concern and interest to the nano industry, and the business strategies most likely to be successful in a challenging economy.
SW: What companies are at the forefront of nanotech EHS today?
LB: That is a hard question to answer as there are many companies contributing greatly to nano EHS excellence today. Certainly, DuPont is to be commended for its collaboration with the Environmental Defense Fund in creating the Nano Risk Framework, http://www.nanoriskframework.com, which is the premier framework for ensuring the responsible development of nanotechnology. I reference DuPont by name as its development of this useful business tool has helped immeasurably in promoting nano EHS. There are many, many other companies, large and small, as well as entities, public and private, that have contributed greatly, too numerous to note by name. Government entities are also to be commended. In particular, EPA’s New Chemicals Division staff and leadership, Jim Willis, Jim Alwood, and Kristan Markey, to name a few; NNI leadership, Clayton Teague; and National Institute for Occupational Safety and Health (NIOSH), Chuck Gerasi, have all made valuable contributions to promoting the responsible development of nanotechnology.
SW: What can the nanotech community learn from other industries’ experience with EHS?
LB: Perhaps the most important lesson is to innovate with a view toward considering the life cycle consequences of product design and to communicate regularly and often with all stakeholders. Nanotechnology offers tremendous promise as a pollution prevention tool. Its benefits must be advocated relentlessly. All too often the areas of uncertainty regarding potential risk posed by unbound nanoscale materials eclipses other aspects of nano innovations. Nano stakeholders and business people need to be able to make the case that nano innovations are designed and engineered to be better, more efficient, and more benign than their macro counterparts, and to be able to demonstrate these features at all stages of the product’s life cycle. Nano stakeholders must also commit to a higher level of transparency in their business dealings, and more robust outreach and education to ensure the public is aware of the promise of nanotechnology, and embraces it, and understands the benefits and manageable risks of nanotechnology as any other emerging technology. To the extent the genetically modified organisms (GMO) experience has taught us anything, it is that public confidence is an essential element in the calculus of achieving success. That a company, or an industry for that matter, is selling a shiny new widget that is the next “it” means nothing if the public does not buy it. I have faith in human nature and believe fundamentally that people “get” nano, but industry must accept its role as an advocate for the technology and relentlessly educate and steward the technology properly to ensure its growth, and redouble efforts to ensure the highest standards of EHS excellence.
SW: For companies that need assistance with EHS issues, what kinds of services does your firm provide to the nanotech community?
LB: We offer a wide variety of services to the nanotech community, and are uniquely qualified to do so. B&C professionals have long worked with EPA’s OPPT staff on TSCA Inventory and nomenclature issues. We work with clients on precisely these matters and on EPA’s evolving TSCA regulatory framework, as it relates to nanomaterials and nanostructures that consist of chemical substances.
Importantly, and as innovators know, new chemical substances, including those manufactured at the nanoscale, must be reviewed by EPA. An important part of our practice is assisting innovators wishing to commercialize their nano innovations by working with EPA scientists and regulators in meeting their compliance obligations under TSCA. Similarly, nanopesticides and inerts must be reviewed by EPA’s OPP under FIFRA. We assist clients in preparing for this review, and in compiling FIFRA registration applications.
We have also actively participated in the initial efforts of several offices within FDA to assess the effect nanotechnologies may have on the data requirements for different FDA approvals and clearances. B&C co-hosted with the Office of Food Additive Safety (OFAS) a meeting to discuss whether and how nanotechnologies might impact guidances issued by OFAS regarding the chemical and toxicological data needed to support a food contact notification. We also monitor how the use of nanotechnologies in drug delivery systems may affect the already complicated jurisdictional issues faced when a product contains both a drug and device component. The Office of Combination Products within FDA must sort out these issues, as well as determine the extent to which different components of FDA become involved in the review of drug delivery systems. We will seek to ensure that issues of nanotechnologies are considered in their proper context by FDA, as it develops a comprehensive policy on the regulation of products produced employing nanotechnologies.
Similarly, B&C has significant experience in counseling clients and conducting advocacy initiatives with the National Toxicology Program (NTP) and has worked for years with scientists inside and outside of NTP on science policy issues involving testing protocols, the development of analytical methods, and related topics. B&C represents many companies and trade organizations that have disputed, or are in the process of disputing, the findings of an NTP study. Our assistance in this regard has consisted of marshaling the technical resources necessary to launch a comprehensive review of the findings, drafting the advocacy documents necessary to support such an effort, and representing our clients in discussions with NTP staff. Given NTP’s current research initiatives involving nanoscale materials, this experience is invaluable.
We also work closely with companies and chemical testing consortia to ensure that NTP’s selection of chemicals, protocols used once a chemical has been nominated for chemical testing, and the technical conclusions and inferences drawn from the test results are presented in a fair and technically defensible way. B&C offers clients an NTP tracking system that advises clients of the status of NTP’s chemical testing initiatives with respect to particular chemical compounds. This tracking system allows companies an opportunity proactively to participate in the chemical testing process. Doing so helps blunt the possibility for erroneous test results, and hence minimizes the possibility that ill-conceived conclusions will be drawn with respect to test chemicals.
B&C routinely counsels clients on a wide variety of matters under the Occupational Safety and Health Act. B&C professionals have also long worked with NIOSH on a wide range of issues addressing workplace safety. We assist clients in developing compliance plans and business protocols that successfully meet their obligations under occupational safety and health laws, and related employee-protection standards.
Finally, we assist clients with a variety of business needs – supply agreements, insurance coverage issues, hazard communication and labeling needs, and a whole range of other business needs.
SW: Thanks again for your time, Lynn. We appreciate your insights on nanotech EHS and wish your firm all the best.
Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
Posted on December 8th, 2010 in Uncategorized | No Comments »
Posted on December 6th, 2010 in Uncategorized | No Comments »
Our good friend, Dr. Mike Roco http://wtec.org/nano2/#Coordinator would like to share with you “Nanotechnology Research Directions for Societal Needs in 2020.” Report Nano2 http://wtec.org/nano2/, which was placed for comments on Sept. 30 and posted in October 2010 is the international long-term view, with retrospective for the last ten years (2000-2010) and vision for the next ten years (2011-2020), prepared with input from leading experts from 35 countries (representing broader community for academic, industry and government stakeholders, including NNI). The full report, full set of slides and webcast are available on wtec.org/nano2/.
The next step is the preparation of the NNI three (2011-2013) year plan with what the US government agencies should do in regard to the bigger picture. This report has used the Nano2 report as input. The following step is the FY 2012 Annual Plan following the two reports: “Nano2 ten year Vision Long by 2020″ report (Sept. 2010) and the 3-year Strategic Plan (Dec. 2010) as reference.
We encourage all members of the Nanotechnology Community to review the original report Nano2 http://wtec.org/nano2/.
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Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”