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Assessing nanoparticle risk poses prodigious challenges
MacPhail, R., E. Grulke, AND R. Yorkel. Assessing nanoparticle risk poses prodigious challenges. WIREs Nanomedicine and Nanobiotechnology. Wiley InterScience, Silver Spring, MD, 5:374-387, (2013).
Risk assessment is used both formally and informally to estimate the likelihood of an adverse event occurring, for example, as a consequence of exposure to a hazardous chemical, drug or other agent. Formal risk assessments in government regulatory agencies have a long history of practice. The precision with which risk can be estimated is inevitably constrained, however, by uncertainties arising from the lack of pertinent data. Developing accurate risk assessments for nanoparticles and nanoparticlecontaining products may present further challenges because of the unique properties of the particles, uncertainties about their composition and the ppulations exposed to them, and how these may change throughout the particle’s life cycle. This review irtroduces the evolving practice of risk assessment followed by some of the uncertainties that need to be addressed to improve our understanding of nanoparticle risks. Given the clarion call for life-cycle assessments of nanoparticles, an unprecedented degree of national and international coordination between scientific organizations, regulatory agencies and stakeholders will be required to achieve thisgoal.
There is growing concern over the potential adverse effects of nanoparticles on the health of exposed humans and the environment. Numerous articles have been written about nanoparticle risk, but most focus on either exposure assessment (and methods) or on testing schemes (including tiered testing). This invited article provides background information on the NRC (1983) risk assessment paradigm, and more recent developments. The article also describes the numerous sources of uncertainty encountered in a risk assessment, using the EPA RfD process as a template, and the extent of knowledge regarding those sources as they pertain to nanoparticles. Virtually all expert committees have advocated a lifecycle approach to assessing nanoparticle risks, which suggests that coordination among all pertinent regulatory agencies and stakeholders will be imperative.
Record Details:Record Type: DOCUMENT (JOURNAL/PEER REVIEWED JOURNAL)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB
TOXICOLOGY ASSESSMENT DIVISION