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 May be of Concern in some processes
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.
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.
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 Health Policy
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 “Secretarial Policy Statement On Nanoscale Safety”
10 CFR 851 Appendix A 11 “Nanotechnology Safety – Reserved
DOE N “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 ( , Rev 3a).
ASTM E , Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings.
ISO/TR ( ), Nanotechnologies- Health and Safety Practices in Occupational Settings Relevant to Nanotechnologies.
ASTM E , 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” ( )
DOE P 456.1, “Policy on Nanoscale Materials ( )
DOE N 456.1, “The Safe Handling of Unbound Engineered Nanoparticles” (1-5-09)