Nanotechnology Policy, Standards, and Guidance

Bill McArthur, PhD, CIH

Director, Office of Worker Safety and Health Policy

Office of Health and Safety

Standards and Guidance

Nanotechnology

New Nano Products3-4 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

Nanoparticles

Engineered NanoparticlePurposely produced with one dimension between 1 and 100 nanometers

Unique physical and chemical properties

Characteristics include:Size

Shape

Surface area

Charge

Chemical properties

Solubility

Health Effects

LITTLE is known about the effect of Nanoparticles on Human Health

Precautionary Measures Are Warranted

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

Exposures

Low Risk of ExposureComposites

Surface coated

Integrated circuits

May be of Concern in some processes

Cutting

Grinding

MaintenanceCleaning and disposal of materials

Exposures

Increased Risks of ExposuresWorking with Liquids

Inadequate protection (i.e., gloves)

Mixing, Pouring, Agitation of materials

Handling/ Generation in non-enclosed systems

Weighing

Blending

Spraying

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

Controls

Limited Information on Health RisksEducation and Training

Establish criteria Engineering controls i.e., ventilation

Selecting PPE

Evaluate Exposures

Use engineering controls similar to aerosolsHEPA should effectively remove nanomaterials

Good Work Practices

Respiratory Protection / PPE in general

Medical Surveillance

Health Surveillance Essential for Effective Occupational Safety and Health ProgramNo Clear Approach to Medical Surveillance for NanoworkersNIOSH

“… 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.

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.

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.

Nanotechnology Policy at the Department of Energy

DOE Directives System

Departmental Expectations for Federal Staff Conveyed by DirectivesTypes of Directives

Policy – High Level

Notice – 1 year limit

Order – List Requirements

Guides andTechnical StandardsGuidance Only

Apply to Contractors Only if In Contract

Contract Mechanism

Department of Energy Accusation Regulations (DEAR)

List A – RequiredRules, State, and Local Requiremnts

List B – Negotiated

RulesFollow Administrative Procedures Act

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

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 FY 2007: $258M at DOE (nearly $100M in construction and operation of scientific user facilities, and over and operation of scientific user facilities, and over $150M in basic research)$150M in basic research)DOE-supported research activities span a broad range of DOE-supported research activities span a broad range of nanotechnologies nanotechnologies DOE user facilities provide state-of the-art resources to DOE user facilities provide state-of the-art resources to the science and technology community via peer-the science and technology community via peer-reviewed allocation of instrument time, staff support, reviewed allocation of instrument time, staff support, and collaborationand collaboration

Why DOE Needs Nanotech Policy

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 – ReservedDOE N 456.1 “The Safe Handling of Unbound Engineered Nanoparticles”

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

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

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

Obtain Concurrences

Publish DirectiveDepartmental Review

Review and Comment System – Rev-ComAll Essential Comments Must be Resolved

Notice published – Jan 05, 2009Requirements

Requirements for Federal Laboratories

Contractor Requirements Document (CRD)Must be added to Contracts

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)