Presentations

Introduction: “Nanomaterials: Definitions and Challenges”

Mark Wiesner, Duke University Center for the Environmental Implications of NanoTechnology, Director

Presentation

“Industry Perspective: Where are we and how did we get here?”

Chad Holliday, DuPont, Chairman of Board and former CEO

“Nanomaterials: Bench to Market. Using the Fabrication Technologies from the Microelectronics Industry to Make Highly Uniform, Shape-Specific Carriers for Drug Delivery and Vaccines”

Joe DeSimone, University of North Carolina Chancellor’s Eminent Professor of Chemistry and North Carolina State University William R. Kenan, Jr. Distinguished Professor of Chemical Engineering

A culture of entrepreneurship and its concomitant means for translating discoveries into the marketplace in order to make a difference to society is essential at research universities today. Faculty members who are also entrepreneurs bring a depth of understanding and experience to the classroom that has an unparalleled effect in inspiring and educating the next generation of students.

This presentation will focus on the technology and the people behind our recent research efforts to translate promising drug delivery discoveries into benefits for patients. We are taking a pharmaco-engineering systems approach to develop the next generation of delivery systems with programmable multi-functional capability. Our laboratory has pioneered the development of a technique called PRINT (Particle Replication in Non-wetting Templates) which is a remarkable top-down particle fabrication method that extends the nano-fabrication techniques from the semiconductor industry to a high throughput, continuous roll-to-roll process. PRINT employs master templates, made using state-of-the-art lithographic techniques, to pattern a silicon wafer, to make polymeric “Teflon-like” molds from a unique class of photochemically curable fluoropolymers called perfluoropolyethers (PFPEs). PRINT enables the fabrication of precisely defined micro- and nano-particles with control over particle size (20 nm to >20 micron), shape, chemical composition, cargo (therapeutics, proteins, oligonucleotides, siRNA imaging agents), modulus (stiff, deformable) and surface chemistries (antibodies, PEG chains, metal chelators), including the spatial distribution of ligands on the particle. In the history of drug delivery, particles have never had the uniformity, precision and chemical and shape control afforded by PRINT. This discussion will include the use of PRINT to design vaccines, targeted cancer therapeutics, delivery vehicles for siRNA and inhalation products.

Presentation available upon request by emailing martinarmes AT nc.rr.com.

“Life Cycle Approaches to Risk Analysis: Maximizing Benefits”

Jo Anne Shatkin, CLF Ventures, Inc., Managing Director

Emerging technologies offer the promise of health, environmental and economic benefits. Early evaluations of potential adverse impacts associated with new technologies allow the opportunity to develop sustainable technologies that maximize benefits and minimize risks. Approaches using life cycle analysis, risk assessment, and screening level assessments inform sound decision making and identify “hot spots” or areas for reconfiguration in early stages of technology development.

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WORK GROUP 1: NANOMATERIALS FABRICATION

“Nanomaterials Production: Addressing EH&S Uncertainty”

Brad Brooks, IBM, Corporate Environmental Affairs & Product Safety

For companies engaged in nanomaterials research or production, the promise of nanotechnology and its potential technical, economic and social benefits has never been closer to realization. Yet, there remain environmental, health and safety information gaps due to the complexity and diversity of nanomaterials under study. How can companies proceed with research, development and production in the face of this uncertainty? A vignette of what IBM has done to address responsibly and ethically the uncertainty in this space will be presented as a short case history. Best practices, benchmarking strategies and chemical management programs will also be discussed.

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“Source of Environmental and Health Concerns in the Fabrication of Nanomaterials”

Jie Liu, Duke University Department of Chemistry

The environmental and health impact from nanomaterials is becoming a major concern as the applications that could benefit from these materials moving closer to market. The impact from the fabrication and application of these materials is multifaceted, not limited to the effect from the materials themselves but also to the process of the synthesis and fabrication. Taking carbon nanotube synthesis as an example, the use of light catalyst powder, strong acid for purification, high pressure gas for precursor etc. all could cause environmental and health concerns if not handled carefully. The society need to be aware of these potential impacts and develop protocols for safety procedures to protect the workers as well as the general public from potential harm.

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“Nano-films and Nano-particles Preparation and Challenges”

Gregory Parsons, North Carolina State University Director of Nanotechnology Initiative and Department of Chemical and Biomolecular Engineering

Humans have been exposed to naturally occurring nanoscale objects, including nanoscale dust and sand, and bacteria and viruses, for thousands of years, and most are not noticed and do not cause ill effects. However, there is growing concern that newly engineered nanoscale particles and structures with chemical formulation and composition not found in nature could lead to adverse biological responses in humans and other living organisms. Nanoscale wires, tubes, particles and films are now showing up in high brightness, low power lighting, sunscreens and cosmetics, and are being explored for biological imaging, as well as disease diagnosis and treatment. As new applications begin to move out of the laboratory setting and into large-scale manufacturing, new questions arise regarding suitability of the materials in the environment, in our bodies, or in contact with people on an every-day basis. This presentation will review important questions related to safe and responsible management of nanomaterials fabrication as we develop new nano-engineered materials, devices and systems.

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“Emerging Nanotechnology: A New Risk Factor for Occupational Lung Disease?”

James Bonner, North Carolina State University Environmental and Molecular Toxicology

Nanotechnology holds the promise of revolutionizing our society, bringing numerous beneficial innovations to improve structural materials, electronics, energy, medical imaging, and drug delivery, amongst other applications. However, nanomaterials present potential safety concerns, and there is accumulating evidence to suggest that nanoparticles may exert adverse effects on the lung and other organ systems. This presentation will overview of the potential risks of engineered nanoparticles and nanotechnology on the respiratory system and highlight recent findings related to pulmonary and systemic effects of inhaled nanoparticles. Special emphasis will be given to carbon nanotubes and the possibility that these nanoparticles could represent an emerging risk for environmental and occupational lung disease, especially in individuals with pre-existing respiratory diseases such as asthma.

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WORK GROUP 2: NANOMATERIALS INTEGRATION INTO PRODUCTS

“Nano-enabled Products Manufacturing: Workplace Risks”

Jurron Bradley, Lux Research

Products touched by nanotech stand to generate $254 billion in 2009 and $2.5 trillion in 2015, fueled by a strong 54% CAGR. Growing along with the market forecast are questions about manufacturing risks to workers. Because of this, this presentation will focus on four points: 1) The nanotechnology value chain – nanomaterials, nanointermediates, and nanoenabled products – with a focus on the later stages of nanointermediates and nano-enabled products; 2) The most prevalent nanomaterials and nano-enabled products and their exposure risks; 3) The status of EHS research; 4) A starter list of questions that need to be answered regarding worker safety.

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“Environmental, Safety, and Health Implications for Airborne Nanomaterials”

Michele Ostraat, RTI International, Director of Center for Aerosol Technology

This presentation highlights many of the broad implications of airborne nanomaterials for occupational and environmental safety and health. Until risks and hazards from airborne nanomaterials are established, appropriate work place controls and best practices must be used to minimize occupational exposure of engineered nanomaterials during synthesis, handling, and processing. In addition to occupational safety and health, this talk will highlight some environmental implications of nanomaterials, including how nanomaterials can become airborne through proper as well as unintended use of nanomaterial-containing products. A background on inhalation toxicology of nanomaterials will highlight best practices while identifying areas that require additional investigation.

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“Evaluating Dermal Hazards Associated with Nanomaterials”

Nancy A. Monteiro-Riviere, North Carolina State University Center for Chemical Toxicology Research and Pharmacokinetics

Exposure of skin to nanomaterials may occur in environmental and occupational settings as well as after topical dosing with cosmetic or pharmaceutical formulations. There are two phases to assessing hazard and risk after such exposure: penetration and toxicity to cellular elements of the skin. The focus of this presentation is to review studies on skin penetration of topically applied nanomaterials (fullerenes, quantum dots, titanium, silver and aluminum nanoparticles) and their subsequent effects on human keratinocytes. Penetration and absorption was assessed by confocal microscopy, transmission electron microscopy as well as chemical analysis. The common results of these studies are that dermal absorption with subsequent systemic exposure is minimal to nonexistent although material penetration into the stratum corneum occurs. Formulation, surface chemical alterations, mechanical stressing of skin and species used can modulate the results. However, should particles penetrate the viable epidermis, keratinocytes are capable of taking up all types of particles with resultant biological effects including cytotoxicity and pro-inflammatory cytokine release. Keratinocyte cellular uptake pathways have been defined for quantum dots. These studies begin to define the hazard from cutaneous nanomaterial exposure and underline common issues that must be considered for proper conduction and interpretation of such studies.

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“Managing Potential Risks and Liabilities from Nanomaterials”

Lynn L. Bergeson, Bergeson & Campbell, PC

The inclusion of nanomaterials in products offers tremendous commercial value and poses challenging risk management dilemmas. Because nanoscale materials are imperfectly understood, marching bravely forward into this new commercial frontier requires thoughtful risk management skills. Evolving legal requirements can be difficult to discern, let alone follow. Hazard communication and risk mitigation are conceptually easier to outline than they are to implement in real time. Anticipating and managing potential end-of-life liabilities similarly are difficult to define with precision and thus hard to insure and protect against. This presentation outlines the evolving legal standards that apply when nanoscale materials are used in the workplace and embedded in products that travel through the value chain through to the end of their useful life, and considers the legal utility of a growing body of emerging best practice standards and their legal implications.

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WORK GROUP 3: NANOMATERIALS DISPOSAL AND END OF LIFE ISSUES

“Risk and Regulatory Issues Associated with the Disposal of Nanomaterials”

Steve Beaulieu, RTI International, Manager, Health and Ecological Risk Assessment Program

The EPA’s Office of Resource Conservation and Recovery (ORCR) has been successfully managing wastes under RCRA for more than two decades, and has made significant progress in the safe management of industrial wastes. Recently, ORCR has begun to focus on alternative strategies for the safe management of industrial material, including beneficial reuse to replace virgin materials. Health and environmental risk assessment has been a critical component of EPA’s decision-making process, providing important insight into safe management and reuse options. However, with the rapidly increasing production of nanotechnology-based materials, ORCR has become concerned with the health and ecological implications of these materials entering municipal and industrial waste streams and/or the beneficial reuse of nanomaterial-containing materials. With the fate and transport properties and toxicology of nanomaterials just beginning to be understood, ORCR is starting to develop a strategy for safe management under RCRA. This presentation will provide an overview of management options and beneficial use scenarios for nanomaterials, and discuss the challenges associated with developing an effective risk assessment strategy given significant uncertainties.

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“Current Knowledge on Nanomaterial Toxicity: Implications for assessing product safety at the end of the life-cycle”

*Nigel Walker, NIEHS NTP Nanotechnology Safety Initiative *

Nanoscale materials (nanomaterials, nanoparticles), are a broadly defined set of substances that have at least one critical dimension less than 100 nanometers and possess unique optical, magnetic, or electrical properties. While nanomaterials are already appearing in commerce there has been only limited research on their potential toxicity in mammalian systems. The unique and diverse physicochemical properties of nanoscale materials suggest that toxicological properties may differ from materials of similar composition but different size. Ongoing research is showing that decreasing particle size below barrier cutoffs for portals of entry can lead to new unintended routes of exposures. In addition, once internalized, surface-based interactions can have profound impacts on the kinetics and bio-distribution of materials of similar size and shape leading to large differences in target organ dosimetry. Finally, for some nanomaterials, “dose” for certain responses can scale with a size-dependent property such as surface area, thus assessments of relative risk based on mass-based dose may lead to erroneous assertions of relative risk. Research is also showing that because of issues such as agglomeration, depending on the experimental conditions used to evaluate toxicity, what was “tested” will often bear little resemblance to that material initially under evaluation. These issues have big implications for assessing the risks of nanomaterials near the end of their life cycle since safety assessments of nanomaterials that go into consumer products may not necessarily be appropriate for those materials as they may be encountered during disposal of that same product.

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“Ecotoxicological Considerations for Nanomaterials Disposal and End-Of-Life Issues”

Stephen Klaine, Clemson University Institute of Environmental Toxicology

Nanomaterial production, use, and disposal have the potential for inadvertent releases into the ecosystem. Understanding the toxicological consequences of these releases provides the basis for developing quantitative ecological risk assessments necessary for prudent management of these materials. Toxicological impacts may occur at several levels of organization from molecular to individual to ecosystem and these impacts may be influenced by their physical and chemical characteristics. This presentation will review our present understanding of the ecotoxicology of nanomaterials and discuss research needs necessary for their management.

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“Communicating About Nanoscience Risks and Benefits”

David Berube, North Carolina State University Director of Public Communication of Science and Technology Project

The presentation examines data from an expert survey on the characteristics, categories, and applications of nanoparticles. Risks are unpacked by experts much differently than by less expert audiences. This research is the first in a set generated by PCOST at NC State examining the public proclivity to intuit their way through complex toxicological data sets. Further complicating this effort has been the demise of traditional reporting of science and technology information of all sorts and the ascendency of social media reporting. The data from the expert survey is being matched with a public survey currently underway. These projects are supported by the National Science Foundation (Grant No. 0809470).

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WORK GROUP DRAFT RECOMMENDATIONS

The following are draft recommendations from each of the three work groups generated at the October 8-9 Summit. Members of the event’s planning committee along with other speakers and participants will further develop and refine these recommendations over the coming months. Please check back for updates or contact Collaborative executive director Martin Armes for more details (martinarmes AT nc.rr.com).

Nanomaterials Fabrication Draft Recommendations

Nanomaterials Integration into Products Draft Recommendations

Nanomaterials Disposal and End of Life Issues Draft Recommendations