Abstract
The need for nanomaterials biosafety and risk assessment is an offshoot of the widespread use of nanoscale particle (NP)-derived materials in over 300 nanotechnology-based products already in commerce, including over 70 healthcare-related products (WWICS, 2006). Rapid advances in material sciences research and the advent of new and highly sophisticated nanofabrication technologies have yielded a vast array of products with poorly established life-cycle risks to health and safety and with potential adverse impact on the environment. As a result, regulatory agencies in the United States and Europe have taken preliminary steps to regulate NP-based products, including pharmaceuticals and cosmetics, fine chemicals, DNA vaccine and gene therapy delivery systems, next generation antibiotics, and immune modulators, for associated potential health, safety, and environmental risks. However, much of the current literature on NP safety and risk assessment grapples with fundamental disagreements in the classification schema for nanomaterials; the lack of a common analytical framework to capture the physiochemical and biological properties constituting risk assessment parameters such as hazard, dose, exposure, and risk; and relatively poor data on occupational safety and health related to the process engineering and manufacture of NP-derived products. Most of all, conventional toxicological principles based on mass per unit volume of the test material to determine dose-response relationship for toxicity and safety assessment may not hold for nanotechnology-derived products. Based on the author's extensive support to U.S. regulatory agencies in the design and development of novel risk assessment paradigms for new chemical compounds with limited or no published toxicity literature, as well as combinatorial chemicals risk assessment strategies where conventional toxicological methods often yield unpredictable dose-response relationships, the author has developed a conceptual framework for an integrated life cycle analysis (LCA) to perform hazard/safety assessment for NP-based products similar to the Safety Data Sheet (SDS) development process. The proposed framework allows systematic capture of safety data unique across the product development life cycle to perform hazard and safety assessment. This approach is better suited to assist development of occupational safety and health guidelines during NP process engineering and manufacturing activities.