3Nanotechnology New Nano Products 3-4 per weekEconomic Impact (with in next 10 years)$1,000,000,000,000 - global economy2,000,000 - workers1,000,000 - U.S. workers
4Nanoparticles Engineered Nanoparticle Purposely produced with one dimension between 1 and 100 nanometersUnique physical and chemical propertiesCharacteristics include:SizeShapeSurface areaChargeChemical propertiesSolubility
5Health EffectsLITTLE is known about the effect of Nanoparticles on Human HealthPrecautionary Measures Are Warranted
6Health Effects Respiratory system – greatest potential for exposure IngestionSkin ContactNanoparticles 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
7Exposures Low Risk of Exposure May be of Concern in some processes CompositesSurface coatedIntegrated circuitsMay be of Concern in some processesCuttingGrindingMaintenanceCleaning and disposal of materials
8Exposures Increased Risks of Exposures Working with Liquids Inadequate protection (i.e., gloves)Mixing, Pouring, Agitation of materialsHandling/ Generation in non-enclosed systemsWeighingBlendingSpraying
9Exposures MeasureUncertain what Measures should be used to Monitor exposuresMass and bulk chemistry < important than size, shape, surface area and chemistryBackground measurements before productionEvaluation engineering controls and work practice
10Controls Limited Information on Health Risks Education and Training Establish criteriaEngineering controls i.e., ventilationSelecting PPEEvaluate ExposuresUse engineering controls similar to aerosolsHEPA should effectively remove nanomaterialsGood Work PracticesRespiratory Protection / PPE in general
11Medical SurveillanceHealth 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.
12Medical 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.
13Medical 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.
14Nanotechnology Policy at the Department of Energy
15DOE Directives SystemDepartmental Expectations for Federal Staff Conveyed by DirectivesTypes of DirectivesPolicy – High LevelNotice – 1 year limitOrder – List RequirementsGuides andTechnical StandardsGuidance OnlyApply to Contractors Only if In Contract
16Contract Mechanism Department of Energy Accusation Regulations (DEAR) List A – RequiredRules, State, and Local RequiremntsList B – NegotiatedRulesFollow Administrative Procedures Act
17Worker Safety and Health Policy DOE Order 440.1B ‘Worker Protection Management for DOE and NNSA Federal Employees’Applies Only to Federal Employees10 CFR 851 ‘Worker Safety and Health Program’Applies Only to Contractor Employees10 CFR 850 ‘Chronic Beryllium Disease Prevention Program’Applies to both Federal and Contractor Employees
18Why DOE Needs Nanotech Policy DOE has critical interests in this area, and a major role in the federal research and development initiativeFY 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 nanotechnologiesDOE 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
20Nanotech “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 – ReservedDOE N “The Safe Handling of Unbound Engineered Nanoparticles”
21Development 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
22Work with Stakeholders Nanotechnology Notice Working GroupOffice of Health, Safety and SecurityUnder Secretary for ScienceNational Nuclear Safety AdministrationUnder SecretaryNational Laboratory Directors Council
23Develop Directive Leverage existing stake holders knowledge Leverage Existing Standards and DraftsNSRC - Approaches DocumentASTM – Terminology for NanotechnologyASTM – Guide for Handling Unbound Engineered Nanoparticles in Occupational SettingsNIOSH – Approaches to Safety NanotechnologyUse existing knowledge of highly hazardous operations
24Obtain Concurrences Publish Directive Departmental ReviewReview and Comment System – Rev-ComAll Essential Comments Must be ResolvedNotice published – Jan 05, 2009RequirementsRequirements for Federal LaboratoriesContractor Requirements Document (CRD)Must be added to Contracts
25ReferencesDepartment 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)