Nanotechnology Policy, Standards, and Guidance

1. Nanotechnology Policy, Standards, and Guidance Bill McArthur, PhD, CIH Director, Office of Worker Safety and Health Policy Office of Health and Safety

2. Standards and Guidance

3. Nanotechnology • New Nano Products • 3-4 per week • Economic Impact (with in next 10 years) • $1,000,000,000,000 - global economy • 2,000,000 - workers • 1,000,000 - U.S. workers

4. Nanoparticles • Engineered Nanoparticle • Purposely produced with one dimension between 1 and 100 nanometers • Unique physical and chemical properties • Characteristics include: • Size • Shape • Surface area • Charge • Chemical properties • Solubility

5. Health Effects • LITTLE is known about the effect of Nanoparticles on Human Health • Precautionary Measures Are Warranted

6. Health Effects • Respiratory system – greatest potential for exposure • Ingestion • Skin Contact • Nanoparticles can enter the blood stream and translocate to other organs (animal studies) • Lung Fn decrement, obstructive and fibrotic lung disease (worker studies) • Research is Needed

7. Exposures • Low Risk of Exposure • Composites • Surface coated • Integrated circuits • May be of Concern in some processes • Cutting • Grinding • Maintenance • Cleaning and disposal of materials

8. Exposures • Increased Risks of Exposures • Working with Liquids • Inadequate protection (i.e., gloves) • Mixing, Pouring, Agitation of materials • Handling/ Generation in non-enclosed systems • Weighing • Blending • Spraying

9. Exposures Measure • Uncertain what Measures should be used to Monitor exposures • Mass and bulk chemistry < important than size, shape, surface area and chemistry • Background measurements before production • Evaluation engineering controls and work practice

10. Controls • Limited Information on Health Risks • Education and Training • Establish criteria • Engineering controls i.e., ventilation • Selecting PPE • Evaluate Exposures • Use engineering controls similar to aerosols • HEPA should effectively remove nanomaterials • Good Work Practices • Respiratory Protection / PPE in general

11. Medical Surveillance • Health Surveillance Essential for Effective Occupational Safety and Health Program • No Clear Approach to Medical Surveillance for Nanoworkers • NIOSH • “… insufficient scientific and medical evidence now exist to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles. However, NIOSH did recommend that hazard surveillance be conducted as the basis for implementing control measures.

12. Medical Surveillance • ISO/TR 12885:2008(E) • It is recommended that a basic worker health monitoring program is established.72 Such a program should include at a minimum: 1. identifying staff (nanoparticles workers) exposed to engineered nanoparticles of unknown healtheffects; 2. conducting workplace characterization and worker exposure assessments; 3. providing nanoparticles workers with “baseline” medical evaluations and including them in anonspecific routine health monitoring program. It is recommended to ensure that engineered nanoparticle workers are offered periodic medical evaluationsthat might include routine tests such as pulmonary, renal, liver, and hematopoietic function testing.

13. Medical Surveillance • ASTM E 2535 – 07 • Medical Surveillance—For guidance on medical surveillance of UNP workers consult the NIOSH Nanotechnology homepage. • 9.4.5.1 Whether a medical surveillance program is warranted is a management decision to be made in consideration of a number of factors including; whether there is good reason to believe that adverse health effects may occur as a result of the contemplated exposure; the invasiveness of the surveillance procedures, the benefits, risks and costs of the surveillance method; and the utility of the information reasonably expected to be generated by the surveillance program. • 9.4.5.2 Any medical surveillance program should be developed and implemented only with medical, industrial hygiene and legal professional consultation, and under the direction of a physician experienced in medical surveillance programs with a high level understanding of the available information concerning the UNP and potential exposure circumstances.

14. Nanotechnology Policy at the Department of Energy

15. DOE Directives System • Departmental Expectations for Federal Staff Conveyed by Directives • Types of Directives • Policy – High Level • Notice – 1 year limit • Order – List Requirements • Guides andTechnical Standards • Guidance Only • Apply to Contractors Only if In Contract

16. Contract Mechanism • Department of Energy Accusation Regulations (DEAR) • List A – Required • Rules, State, and Local Requiremnts • List B – Negotiated • Rules • Follow Administrative Procedures Act

17. Worker Safety and HealthPolicy • DOE Order 440.1B ‘Worker Protection Management for DOE and NNSA Federal Employees’ • Applies Only to Federal Employees • 10 CFR 851 ‘Worker Safety and Health Program’ • Applies Only to Contractor Employees • 10 CFR 850 ‘Chronic Beryllium Disease Prevention Program’ • Applies to both Federal and Contractor Employees

18. Why DOE Needs Nanotech Policy • DOE has critical interests in this area, and a major role in the federal research and development initiative • FY 2007: $258M at DOE (nearly $100M in construction and operation of scientific user facilities, and over $150M in basic research) • DOE-supported research activities span a broad range of nanotechnologies • DOE user facilities provide state-of the-art resources to the science and technology community via peer-reviewed allocation of instrument time, staff support, and collaboration

19. Why DOE Needs Nanotech Policy

20. Nanotech “Policy” • Safety and Health Bulletin “Good Practices for Handling Nanomaterials” • DOE P 456.1 “Secretarial Policy Statement On Nanoscale Safety” • 10 CFR 851 Appendix A 11 “Nanotechnology Safety – Reserved • DOE N 456.1 “The Safe Handling of Unbound Engineered Nanoparticles”

21. Development of Nanotech Policy • Raise Management’s Level of Awareness • ‘Ensuring the Safety and Viability of Nanotechnology’ • Analogies of Other Technology i.e., Nuclear Power and Biotechnology • ‘Nanotechnology White Paper’ • Review of Potential Public and Health, Safety, and Environmental Concerns

22. Work with Stakeholders • Nanotechnology Notice Working Group • Office of Health, Safety and Security • Under Secretary for Science • National Nuclear Safety Administration • Under Secretary • National Laboratory Directors Council

23. Develop Directive • Leverage existing stake holders knowledge • Leverage Existing Standards and Drafts • NSRC - Approaches Document • ASTM – Terminology for Nanotechnology • ASTM – Guide for Handling Unbound Engineered Nanoparticles in Occupational Settings • NIOSH – Approaches to Safety Nanotechnology • Use existing knowledge of highly hazardous operations

24. Obtain Concurrences Publish Directive • Departmental Review • Review and Comment System – Rev-Com • All Essential Comments Must be Resolved • Notice published – Jan 05, 2009 • Requirements • Requirements for Federal Laboratories • Contractor Requirements Document (CRD) • Must be added to Contracts

25. References • Department of Energy Nanoscale Science Research Centers, Approach to Nanomaterial ES&H (5-12-08, Rev 3a). • ASTM E2535-2007, Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings. • ISO/TR 12885 (2008-10-01), Nanotechnologies- Health and Safety Practices in Occupational Settings Relevant to Nanotechnologies. • ASTM E2456-06, Terminology for Nanotechnology. • NIOSH, Approaches to Safety Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (3/2009). • 10 CFR 851, “Worker Safety and Health Program” • DOE O 440.1B, “Worker Protection Program for DOE (Including the National Nuclear Security Administration) Federal Employees” (5-17-07) • DOE P 456.1, “Policy on Nanoscale Materials (9-15-05.) • DOE N 456.1, “The Safe Handling of Unbound Engineered Nanoparticles” (1-5-09)