The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed at (...) emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

The article focuses on issues relating to occupational exposures of researchers and lab workers, and exposures of bystanders such as health care workers and family members during HSR using nanomaterials. Such third-party exposures give rise to unique challenges relating to oversight as well as exposures to worker groups not previously studied. Given the current state of knowledge regarding health risks from such exposures, a more precautionary approach to oversight seems advisable.

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...) The European Medicines Agency reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. (shrink)

Quasi-probability distribution functions fj WW, fj MM for quantum spin-j systems are derived based on the Wigner-Weyl, Margenau-Hill approaches. A probability distribution fj sph which is nonzero only on the surface of the sphere of radius √j(j+1) is obtained by expressing the characteristic function in terms of the spherical moments. It is shown that the Wigner-Weyl distribution function turns out to be a distribution over the sphere in the classical limit.

The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for (...) data on health and safety of their products. These factors have a strong influence on public confidence and health and safety. The oversight system also scored low on attributes such as public input, transparency, empirical basis, conflict of interest, and informed consent. The experts in our sample tend to believe that the current oversight system for chemicals in the workplace is neither adequate nor effective. It is very likely that the performance of the OSHA oversight system for nanomaterials will be equally inadequate. (shrink)

Nanotechnology is a collection of different technologies and approaches dealing with manipulating matter with dimensions on the nanometer scale. The growth of nanotechnology has been rapid in recent years and encompasses a range of industries including pharmaceuticals, chemicals, robotics, medicine, agriculture, electronics, national defense, fiber optics, and energy. Nanoparticles with shapes, morphologies, and chemical compositions engineered for specific functions and applications are now common. While estimates of the numbers of new types of nanoparticles being produced in academic and industrial labs (...) that combine these different characteristics are uncertain, it is likely that they run into the hundreds. (shrink)