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NanoSafe Tested Third Party Verification Process for Characterizing Exposures to Products Containing Engineered Nanomaterials

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44ES030650-02
Agency Tracking Number: R44ES030650
Amount: $1,047,575.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-17
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Blacksburg, VA 24060-6370
United States
DUNS: 809745354
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (540) 443-9287
Business Contact
Phone: (540) 231-5812
Research Institution

Project Summary
Consumer products increasingly contain engineered nanomaterials (ENMs) or generate respirable
particulate matter (PM) at levels known to introduce negative health effects. While ENMs can improve
product capabilities, consumers (and even manufacturers) are often unaware of the dangers presented by
use of some products. Crucially, federal oversight and regulatory measures cannot keep pace with the rate
at which new products are released which contain new ENMs or release large amounts of undetected PM.
Numerous tools and assays already exist which can accurately characterize the size, concentration,
composition, and other properties of ENMs and PM. While additional improvements to characterization
equipment is certainly valuable- especially with regard to the discernment of carbonaceous ENMs from
PM- the greatest impact on human health can be realized through the development of an agile exposure
assessment service using available cutting-edge characterization equipment and broad mass communication
avenues to support safety-conscious manufacturers and protect consumers.
NanoSafe proposes to develop a systematic procedure for rapidly producing robust evaluation protocols for
the independent assessment of exposure risk to airborne ENMs and PM released by consumer products- the
NanoSafe TestedTM program. Exposure evaluations will occur in NanoSafe’s Class 1000 cleanroom, where
ENM and PM concentration and size distribution will be measured alongside sampling for detailed
characterization. In Phase II, developed test protocols for additive manufacturing products and cosmetics
will continue to be refined, with new protocols for other products presenting high ENM/PM exposure risk
to be added, including filtration appliances and masks (Specific Aim #1); this includes evaluation of popular
makeshift personal protective equipment (PPE) designs currently under use by healthcare professionals due
to diminished supplies of PPE during the COVID-19 crisis. Avenues and methods for effectively translating
and communicating technical measurements to a broad consumer base will be developed (Specific Aim
#2), and data management systems toward ISO certification will be constructed along with customer
engagement to refine communication metrics (Specific Aim #3).
In the ultimate commercial vision, NanoSafe will evaluate, classify, and publish the exposure risk presented
to users of ENM-containing and PM-generating consumer products to inform purchasing decisions.
Products demonstrating low ENM exposure risk by NanoSafe TestedTM protocols may earn use of a
NanoSafe TestedTM label or similar classification of merit for purchase by manufacturers, and watchdog
testing performed by NanoSafe will inform the public about products of especially high risk. These efforts
will encourage consumer purchase of safer ENM-containing and PM-generating products, and in turn,
inspire manufacturers to develop consumer products that present lessened ENM and PM exposure risk.

* Information listed above is at the time of submission. *

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