Nanotechnology Initiative

1. Nanotechnology Initiative 2006 National Response Team Worker Safety and Health Technical Conference May 31 – June 1, 2006 Paul F. Wambach, CIHIndustrial Hygienist Office of Epidemiology and Health Surveillance

2. National Nanotechnology Initiative (NNI) • The National Nanotechnology Initiative first funded National Science Foundation in FY-01 to coordinate Federal R&D • 21st Century Nanotechnology Research and Development Act, December 2003 • For FY 2006, estimated R&D funding totals over $1 billion across 11 agencies; 11 additional participating agencies • For more information see the NNI strategic plan at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf

3. 21st Century Nanotechnology Research and Development Act • National Science Foundation • Funds basic research and has a coordination role • National Institute for Science and Technology • Methods for characterizing and naming new materials • Environmental Protection Agency • Funds health protection research • National Toxicology Program • NIOSH http://www.cdc.gov/niosh/topics/nanotech/

4. DOE NNI Mission • Provide the physics, chemistry, and computational tools needed to make nanotechnology possible. • $1.5 billion appropriated over 4 years for building and operating 5 Nanoscale Science Research Centers • Center for Functional Nanomaterials at Brookhaven National Laboratory • Center for Integrated Nanotechnologies at Sandia and Los Alamos National Laboratories • Center for Nanophase Materials Sciences at Oak Ridge National Laboratory • Center for Nanoscale Materials at Argonne National Laboratory • Molecular Foundry at Lawrence Berkeley National Laboratory

5. ES&H Risks of Nanoscale Materials • Chemical reactivity of nanoscale materials different from more macroscopic form, e.g., gold • Vastly increased surface area per unit mass, e.g., upwards of 100 m2 per gram • New physical forms of common chemical elements change properties, e.g. proteins • Do these properties lead to new and unique health risks …?

6. Airborne Nanomaterials Courtesy Andrew Maynard - NIOSH PROCESS Primary Particles Aggregates & Agglomerates Droplets Residue can have nanostructure And high surface area Deposition throughout the respiratory tract and gut Small diameter (~5 - 30 nm) High surface area Deposition throughout the respiratory tract and rapid uptake High surface area Typically ~ 100 - 1000 nm in diameter Deposition in the lung uptake by immune system cells

7. ES&H Challenges • No standard nomenclature or material specifications • Hazard testing not keeping pace with materials development • No exposure limits • Hype – research and materials called nano to gain support • Dread – exotic, unfamiliar hazard

8. Risk Management Initiatives • DOE P 456.1 SECRETARIAL POLICY STATEMENT ON NANOSCALE SAFETY • DOE and its contractors will identify and manage potential health and safety hazards and potential environmental impacts at sites . . . • Nanoscale Science Research Centers Group • NIOSH and ANSI • EFCOG Occupational Safety and Health Group • Nano material: Hazard Assessment, Health Risks, and Safety Analysis Process project was approved at the joint EFCOG/DOE Chemical Management Workshop, March 14-16 • 29 individuals have volunteered to participate.

9. Integrated Safety Management

10. Define Scope of Work • What distinguishes nanotechnology from other material science projects? • Nanoscale Science Research Centers will characterize and test samples of nanoscale engineered materials. • Application of nanotechnology to energy and defense research and development. • Pilot plant scale production operations?

11. Analyze Hazards • Are there equipment and process materials that are unique to nanotechnology? • What assumptions should be made on the hazards of untested materials? • How do we interpret exposure monitoring results without exposure limits? • What medical tests and examinations should be used to monitor nanotechnology workers?

12. Develop and Implement Hazard Controls • Are facility, utility, and equipment codes and standards currently in use for materials sciencesufficient? • Are UK Control Banding or ILO Toolkit strategies useful for health risk management? • Are existing procedures sufficient for assuring visiting scientists know how to protect themselves?

13. Control Banding • Qualitative Job Hazard Analysis • Exposure Bands Instead of OELs • Control Bands • Two flavors • UK HSE COSSH Essentials (and very similar ILO Occupational Risk Management Toolkit) • Pharmaceutical and other industry specific methods

14. Risk Assessment • What is the Health Hazard (Exposure Band) • R phrases from Globally Harmonized MSDS • How much is being used • Low – grams or milliliters • Medium – kilograms or liters • High – Tons or cubic meters • Exposure Pontential • Boiling Point/Operating Temperature • Pellets – Granules - Powder

15. Exposure Bands

16. Control Bands • A – Use Good Industrial Hygiene Practice • B – Use local exhaust ventilation • C – Enclose process • D – Seek specialist advice • Pharmaceutical: No open handling (closed systems required) • E – Seek specialist advice • Pharmaceutical: No manual operations/human intervention (robotics or remote operations required)

17. Pharmaceutical Industry Specific Method • Potency (mg/day) 8-Hr TWA (mg/m3) • >100 >1 • 10-100 0.1-1 • 1-10 0.01-0.1 • 0.1-1 0.001-0.01 • <0.01 <0.001 • Unknown 0.01-0.1

18. Pharmaceutical Industry Specific Method • Uses a more sophisticated health hazard rating method. • MSDSs with R phrases aren’t available • Toxicity data generated during the research and development process • Doesn’t include qualitative exposure assessment • Relatively small number of typical operations

19. Feedback and Improvement • Occurrence Investigation and Reporting • Definition of a nanotechnology occurrence • Health Surveillance • Medical Surveillance – sentinel health event or unusual pattern of injury, illness, or clinical finding • Exposure Surveillance – unusual events or higher than expected exposures • Health and exposure data linked to individual identifier • Routine collection, analysis and dissemination of information to those who need to know

20. Conclusions • NNI legislation has established public policy • Secure the benefits of nanotechnology • Manage the risks • Ready, shoot, aim – Feedback is important • Passive surveillance – injury, illness, and occurrence reporting – has limited ability to answer questions • Active surveillance – worker registries – needed to identify potential health effects as early as possible.