Grand Opportunity Grant Program in Engineered Nanomaterial Environmental Health and Safety (RC2)

Recovery Act Limited Competition for NIH Grants: Research and Research Infrastructure "Grand Opportunities" (RC2)

Engineered nanomaterials (ENM) represent a significant breakthrough in material design and development for medicine, industry, and consumer products. Global demand for nanomaterials and nano-enabled devices is expected to exceed $1 trillion by 2015. This increased production provides increased opportunities for unanticipated exposures with unknown health consequences. The unique physicochemical properties that make engineered nanomaterials so useful also make their interactions with biological systems difficult to anticipate and critically important to explore. Recent studies have shown conflicting results from the traditional assays, methods, and models that are used to assess interaction with biological systems. This inconsistency in findings between different laboratories significantly impedes the integration of research data for risk assessment and public health protection.

The goal of this initiative is to develop reliable and reproducible methods and models to assess exposure, exposure metrics, and biological response to nanomaterials. The coordinated research effort will include diverse routes of exposure to nanomaterials and in vitro and in vivo models of exposure and response. This research is essential for the harmonization of research results, a scientifically sound basis for hazard assessment, and the safe design and development of ENM. This initiative supports the goals identified by the National Nanotechnology Initiative, Strategy for Nanotechnology-related Environment, Health, and Safety Research.

Under this initiative, researchers will leverage existing methods or develop new methods to assess exposure and health effects associated with the unique characteristics of ENMs. Where possible, applications will include methods or approaches to maximize predictive power of their test methods for other ENMs. Research proposals should include the use of appropriate animal models, routes of exposure, and choice of target tissues to identify and characterize the methods being evaluated. Although the environmental exposure levels have not been identified to date, researchers should not propose studies using unreasonably high doses. Appropriate routes of exposure include dermal, oral, and inhalation. All researchers funded under this initiative will utilize the same, agreed upon set of well-characterized ENMs.

Once awards are made, the grantees will participate in a consortium which will meet regularly, either by conference call or face-to-face. The purposes of these meetings will be to determine the specific set of standardized nanomaterials to be used and to finalize the technical details of the exposure and biological methods to be studied. Through ongoing dialogue, the researchers will evaluate the results from the different labs to determine next steps, such as cross-laboratory evaluations of reproducibility and robustness of the new methods.

Applicants must demonstrate their knowledge of engineered nanomaterials and of the fields of exposure assessment and/or safety assessment, and an appreciation of the unique challenges of studying ENMs. Although applications will be reviewed based on the scientific merit of their proposed methodologies, it should be understood that in some cases, the consortium may recommend that awardees use different types of nanomaterials or modify the exposure assessment or biological assays originally proposed.

Examples of research that would be responsive to this FOA include, but are not limited to the following:

• reengineer existing tools or develop new tools to address current limitations in assessing exposure to ENMs in the environment with a high level of temporal resolution
• adapt or develop methods to measure the exposure in ambient air, drinking water, or skin contact and uptake by inhalational, oral, dermal, or gastric routes
• adapt or develop methods to understand systemic, biochemical, pathological, immunologic, genotoxic, and mutagenic potential of ENMs based on cellular, biochemical, molecular, and histological methods to characterize pathobiological endpoints from both in vitro and in vivo exposure scenarios
• establish reproducibility and reliability of test methods or methods developed during this project period using multiple cell culture systems and tissues from multiple laboratory species. The in vitro systems should utilize primary cell cultures and/or co-culture systems and translate these findings to in vivo models
• study the adaptability of test methods under different exposure conditions, including single and repetitive exposures, with biological assessment at multiple time points in order to improve the predictive power and robustness of the methods
• develop methods to predict ENMs toxicity in acute versus sub-chronic exposure study designs as permitted within the two-year period
• develop integrated experimental approach to identify the appropriate dose metric and biological response metric for different classes of ENM for in vitro assays and dose metric, dose rate, and biological response metric for in vivo models

In the applications, applicants should propose a set of well-characterized and available nanomaterials to which humans may be exposed which could be used by the consortium in this program. In addition, applicants should propose to use state-of-the-art methods that are targeted to the specific, unique challenges related to the study of nanomaterials. For instance, while investigators may be guided by past research on other particulate materials, priority will be given to applications that propose innovative methods and study designs that move beyond previous studies and focus on the specific and unique research issues related to nanomaterials.

The NIEHS proposes a commitment of $5 million per year for this initiative to fund 7-8 RC2 applications with a total cost per RC2 not to exceed $600,000/year. Applicants should request funds for two face-to-face meetings per year.

Contact

Sri Nadadur, Ph.D.
Scientific Program Administrator

Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Tel (919) 541-5327
nadadurs@niehs.nih.gov

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