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ONAMI’s - Safer Nanomaterials and Nanomanufacturing Initiative

The ONAMI Safer Nanomaterials and Nanomanufacturing Initiative presents crucial recommendations for the FDA's Nanotechnology Task Force. With the nanotechnology industry projected to be worth a trillion dollars by 2015, there are growing concerns over ecotoxicity, human health risks, and safety. This initiative emphasizes the redesign and safe manufacturing of nanoparticles to enhance performance while ensuring minimal environmental impact. It proposes a structured assessment framework for understanding biological impacts and toxicity testing, crucial for public acceptance and commercialization.

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ONAMI’s - Safer Nanomaterials and Nanomanufacturing Initiative

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  1. ONAMI’s - Safer Nanomaterials and Nanomanufacturing Initiative Recommendations for the FDA Nanotechnology Task Force Stacey Harper

  2. Issues for Nanotechnology Potentially large-scale application (and thus large-scale impact) • Trillion dollar industry by 2015 (NSF Report Societal Implications of • Nanoscience and Nanotechnology, 2001) Growing concerns about ecotoxicity, human health effects and safety • Chemistry and physics different at nanoscale size • Biological interactions largely unstudied • Lack of data: Impossible to assess risk without data Importance of public acceptance • Perceptual risks may be a barrier to commercialization • Activists already making the case that untested nanomaterials are being • forced on the public

  3. Safer Nanomaterials and Nanomanufacturing Initiative (SNNI) Less wasteful nanomanufacturing Better, safer nanoparticles High performance nanodevices http://www.greennano.org/

  4. Nanomaterialsynthesis TestProperties RedesignMaterial Structure/Property Relationships: Physicochemical properties and hazards Designing safer nanoparticles Nanoparticles have widely tunable properties - the key is to enhance performance and safety at the same time

  5. Nanomaterial Effects Database Feed data back into design scheme Testing the biological impacts of engineered nanoparticles Tier 1: Toxicity Screening • Toxicity testing in cells, tissues and whole organisms • In vitro (human cells, tissue cultures) • In vivo (vertebrate models) Tier 2: Cellular Targets and Distribution • Defined in vivo • Fluorescent nanomaterials • Targeted assays Tier 3: Molecular Expression • Molecular (genetic) response • Whole animal gene expression profiles • Vertebrates eye heart

  6. R = -CH2COO-Na+ -(CH2)2COOH -(CH2)11COOH -(CH2)2OH -(CH2)2PO(OH)2 -[(CH2)2O]2(CH2)2OH -(CH2)2O(CH2)2OH -[(CH2)2O]2CH2COOH -(CH2)2COGlyGlyOH -(CH2)2CONH(CH2)14CH3 -(CH2)17CH3 -(CH2)15CH3 -(CH2)11CH3 -(CH2)9CH3 -(CH2)8CH3 -(CH2)7CH3 -(CH2)5CH3 -(CH2)2CH3 -(CH2)2Si(OMe)3 • -(CH2)2SO3-Na+ • -(CH2)3SO3-Na+ • -(CH2)2N+HMe2Cl- • -(CH2)2N+Me3Cl- • (CH2)2O(CH2)2N+Me3-OTs • (CH2)2O(CH2) 2O(CH2)2 N+Me3-OTs • (CH2)2O(CH2) 2O(CH2)2 N+Et3-OTs Nanomaterialsynthesis RedesignMaterial TestProperties A diverse family of functionalized nanoparticles has been prepared for 1.5-nm and 0.8-nm core sizes

  7. Negative Charge (2-mercaptoethanesulfonate) 0.8 nm Example: Toxicity affected by size and surface functionalization Positive Charge (N,N,N-trimethylammoniumethanethiol) 1.5 nm

  8. Recommendations • Characterization and purification done carefully • Identify biological impacts • Identify environmental impacts • Incorporate toxicological evaluations into research and development schemes

  9. Contact Information Jim Hutchison, PhD Director ONAMI Safer Nanomaterials and Nanomanufacturing Initiative hutch@uoregon.edu 541.346.4228 http://greenchem.uoregon.edu Bettye LS Maddux, PhD Assistant Director ONAMI Safer Nanomaterials and Nanomanufacturing Initiative bettye@greennano.org 541.713.1330 http://greennano.org/ Robert Tanguay, PhD Associate Professor Environmental and Molecular Toxicology Oregon State University robert.tanguay@oregonstate.edu 541.737.6514 http://emt.oregonstate.edu/faculty/tanguay.htm Stacey Lynn Harper, PhD NIEHS Research Fellow Environmental Health Sciences Center Oregon State University harpers@science.oregonstate.edu 541.737.2791 http://www.onami.us/NanoNet/researchers

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