Novel Approaches for Characterizing Exposure and Response to Engineered Nanomaterials (R43 Clinical Trials Not Allowed)

Background

Over the past decade the nanotechnology industry has expanded from a clean room technology to small scale industry generating thousands of ENMs now being used in everyday products ranging from personal care products to packaging, construction, water filtration, and children's clothes and toys. This widespread production and use of ENMs present opportunities for unintended human exposures either at occupational settings or from day to day use of nano-enabled products or from environmental sources, while the impact of ENMs on biological systems is not clearly understood.

Through the manufacture and use of ENM-containing products, individuals may be exposed to a diverse set of ENMs of varying size, shape, and composition.  However, the levels of exposures and the biological consequences of those exposures are not known, and ongoing research efforts are addressing these questions.  Our ability to evaluate the potential health risks of ENMs relies not only on understanding how ENMs interact with biological systems, but also on assessing how and to what extent people are exposed to them.

To address those uncertainties, the US Environmental Protection Agency asked the National Research Council (NRC) to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of ENMs. The NRC developed a conceptual framework, Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, and identified critical research gaps and tools needed to address them. These included addressing the critical gaps in knowledge focusing on ENMs that may pose unanticipated risks and on the properties of ENMs and their influence on hazards and exposure. They also identified the need for improved tools including materials, methods, models, and informatics needed to address these gaps. In addition, the committee identified high priority research that needs to be undertaken in the short and long term and the resources needed (https://www.nap.edu/catalog/13347/a-research-strategy-for-environmental-health-and-safety-aspects-of-engineered-nanomaterialshttps://www.nap.edu/catalog/13347/a-research-strategy-for-environmental-health-and-safety-aspects-of-engineered-nanomaterials ).

A workshop co-hosted by CPSC and NNI entitled "Quantifying exposure to engineered nanomaterials (QEEN)' in 2015 assessed the current state of the science and the tools and methods available to characterize and quantify exposure to ENMs from consumer products (https://www.nano.gov/node/1327) also identified the critical need for the development and validation of tools to assess occupational/consumer/environmental exposure to ENMs.

This FOA supports the development of technologies by small business concerns (SBCs) to better characterize exposure to ENMs in occupational, workplace, and home settings, and to expand the capability of screening the range of commonly used ENMs for effects in biological systems.

Objectives

This FOA supports the development of new technologies and approaches that include, but are not limited to:

Sensors and other technologies to monitor exposures to engineered nanomaterials in air, water, and consumer products. Examples include adapting current sensing technologies for ultrafine particles to ENM detection, with the capability of discriminating between ENMs and other ultrafine particles (e.g., anthropogenic black carbon particles).

Tools to characterize composition, surface coating, concentration, size, and size distribution in diverse sources- aerosol, water, biological fluids, food packaging materials

Particle samplers, with time and location data, that can collect ENMs for laboratory analysis, together with scanning technology (light scattering, Raman spectrophotometry) for real-time elemental analysis of carbonaceous ENMs.

High- to mid-throughput assays or high-content assays for characterizing the effects of specific nanomaterials on biological pathways, including cytotoxicity, cellular uptake, inflammatory pathways, and oxidative stress in target tissues (e.g., lung, skin, or GI tract.)

Technologies or approaches that can model persistence and or transformation of ENMs in different environmental media (marine, soil, air, biological fluids)

Applicants should provide a rationale for the choice of ENMs used to develop these approaches and to demonstrate the feasibility of the technology to characterize the exposure to the ENMs or the impact of that exposure on biological pathways. For example, applicants may choose well-characterized ENMs to distinguish between effects of metal-NPs themselves from the associated metal ions. Priorities for choosing test ENMs should be based on high volume production and wide consumer use. Applicants should provide information in the Authentication of Key Biological and/or Chemical Resources section on protocols for verifying the identity, including characterization of the physicochemical properties, of ENMs that will be used as test compounds.

Applicants should provide clear, quantifiable milestones for the Phase I research.

Information on the Nano EHS program can be found at http://www.niehs.nih.gov/research/supported/exposure/nanohealth/index.cfm   

See Section VIII. Other Information for award authorities and regulations.