Nanomaterials and Toxicology: Status and Strategies
Monday, May 14, 2007
Presented by the Predictive Toxicology Discussion Group
Organizers: Andrew Maynard, Woodrow Wilson International Center for Scholars; Donna Mendrick, Gene Logic Inc
Is Nanoparticle Toxicity Predictable?
Günter Oberdörster, PhD
University of Rochester
Engineered nanoparticles (NP) are increasingly used for diverse beneficial applications. Concerns about human and environmental exposures resulting in potential adverse effects have increased as well, yet the data to substantiate or refute those concerns are insufficient. Indeed, many of the same properties of nanomaterials that are exploited for useful applications—such as their large relative surface area, their propensity to enter cells and to translocate to remote target organs—may also contribute to an increased toxic potential. Examples of translocation and effects of nano-sized particles and presumed mechanisms will be highlighted. They reveal major challenges that lie ahead to answer key questions of nanotoxicology. Foremost is the development and validation of simple assays that will allow to predict the toxic potential—low or high—of NP. Such information, together with data of potential human or environmental exposure, is essential to determine as to whether NP pose a real or perceived risk.
Nanotechnology: Politics, Policy and the Public
Kristen Kulinowski, PhD
The trajectory of nanotechnology research and development is determined not only by the academic and industrial technical communities but also by politicians, policy makers and the public. One issue that is perceived to be a potential roadblock for commercialization of nanotech-enabled products is the concern over potential environmental and health impacts resulting from the production and use of nanomaterials. The political and regulatory landscape of nanotechnology is in constant flux as new information emerges. Can or should nanomaterials be treated any differently than other materials of the same or similar chemical composition? Are existing mechanisms equipped to handle this broad new class of materials? Is new regulation or legislation needed, if only to ensure the public that their concerns are being addressed? This talk will provide a review of the current regulatory framework for assessing materials and a discussion of the public perception of nanomaterials.
Nanotechnology and FDA: Challenges and Opportunities
Wendy R. Sanhai, PhD
Office of the Commissioner, U.S. Food and Drug Administration
As part of its mission, FDA is responsible for helping speed innovations to make medical products* more effective, safe, and affordable, which leads to better public health.
Nanotechnology holds huge promise for the design and manufacture of many types of novel medical products----from devices to therapeutics to combination products. There remain, however, a number of questions about the behavior of nanoparticles and the potential effects of products containing nanoparticles once they are introduced into complex human and animal physiology, and even into the environment. We need to better understand the physical and physiological characteristics of different nano-engineered materials. We also need to work with stakeholders to develop new test methods, characterization protocols, nomenclature and standards to efficiently translate potentially meaningful products from proof of concept studies to preclinical and clinical development, manufacture, FDA submission and commercialization. Post-market issues are also under FDA's jurisdiction and will be part of the agency's on-going activities in this area.
Dr. Sanhai will outline some of the challenges the agency is facing in this emerging field and ways FDA is working internally (under its Critical Path Initiative) and with stakeholders (through collaborations) to bri