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

2. 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. 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. 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. 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 m 2 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 PROCESS Primary Particles Aggregates & Agglomerates Droplets 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 Residue can have nanostructure And high surface area Deposition throughout the respiratory tract and gut Courtesy Andrew Maynard - NIOSH

7. 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. 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. 9 Integrated Safety Management

10. 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. 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. 12 Develop and Implement Hazard Controls Are facility, utility, and equipment codes and standards currently in use for materials science sufficient? 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. 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. 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. 15 Exposure Bands

16. 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. 17 Pharmaceutical Industry Specific Method Potency (mg/day)8-Hr TWA (mg/m 3 ) >100>1 10-1000.1-1 1-10 0.01-0.1 0.1-1 0.001-0.01 <0.01 <0.001 Unknown 0.01-0.1

18. 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. 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. 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.