MANAGING NANOTECHNOLOGY ES

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MANAGING NANOTECHNOLOGY ESH AT DOEDOE Notice
456.1

• John W. Peters, CIH, CSP
• Manager, Safety Health Services Division
• Brookhaven National Laboratory
• jpeters_at_bnl.gov

Joint EFCOG/DOE Chemical Safety and Lifecycle
Management Workshop March 11, 2009
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DOE N 456.1 Nanosafety Notice

• Collaborative effort - DDS/NLDC, labs, SC, HSS
• Approved 1-5-09 and expires 1-5-10
• Prior to cancellation ensure requirements are
  integrated into existing DOE directives
• Site required to written report of compliance
  within 60 days of incorporation of CRD in
  contract
• Site must maintain a listing of nanotechnology
  activities

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Definitions

• Engineered nanoparticle
• Intentionally created (in contrast with natural
  or incidentally formed) particle with one or more
  dimensions greater than 1 nanometer and less than
  100 nanometers
• Beyond the scope of this definition
• Biomolecules (proteins, nucleic acids, and
  carbohydrates)
• Materials that have occupational exposure limit
  (OEL) or national consensus or regulatory
  standards for the nanoscale particle
• UNPs incapable of becoming airborne or not
  expected to be generated or released
• Nanoscale forms of radiological materials
• Nanoparticles incidentally produced by
• human activities or natural processes

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Definitions

• Unbound Engineered Nanoparticle (UNP)
• Engineered nanoparticles that, under reasonably
  foreseeable conditions encountered in the work,
  are not contained within a matrix that would be
  expected to prevent the nanoparticles from being
  separately mobile and a potential source of
  exposure
• Bound
• Engineered nanoparticle dispersed and fixed
  within a polymer matrix, incapable, as a
  practical matter, of becoming airborne
• Unbound
• Engineered nanoparticle suspended as an aerosol
  or in a liquid
• Nanomaterial Worker
• Handles UNP and has the potential for inhalation
  or dermal exposure to UNP
• Routinely spends time in an area in which
  engineered UNP have the potential to become
  dispersed in the air
• Works on equipment that might contain or bear UNP
  and that could release UNP during servicing or
  maintenance

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Notice Requirements

• Contractor Process
• Coordinate with subcontractors to extent
  necessary to ensure we comply with the order
• Maintain registry of nanomaterial workers and
  provide Occ-Med with a copy
• Maintain electronic inventory of activities
  involving UNP
• Keep an inventory of all UNP waste that is
  shipped off site
• Provide BHSO an annual review of activities
  involving UNP

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Notice Requirements

• Contractor Process
• Provide BHSO a written statement of compliance to
  N 456.1 within 60 days of incorporation of CRD
  into contract
• Give the unions timely notice of the development
  and implementation of procedures under this CRD
• Include requirements in site safeguards and
  security plans, facility security plans, and
  emergency management programs
• Conduct an annual self-assessment of compliance
  with nanotechnology policies and procedures

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Notice Requirements

• Training
• Provide training to nanomaterial workers and
  their supervisors
• on initial assignment and when new information is
  available
• Exposure Assessment
• Conduct exposure assessment for all UNP work
  using best available hazard information
• Exposure assessment must assess the need for use
  of HEPA exhaust filtration
• Establish an air monitoring program for UNP based
  on preliminary exposure assessments and guidance
  provided in NSRC Approach to Nanomaterial ESH
  (5/12/08, Rev 3a)

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Notice Requirements

• Medical Surveillance
• Offer baseline medical exams to all nanoworkers
• Inform any guest worker of the requirements of
  the medical surveillance portion of this Notice
  but need not offer them baseline medical exams
• Baseline medical evaluation must include
• A general physical exam
• Pulmonary function test
• General blood work
• Other tests or exams as determined by Occ-Med

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Notice Requirements

• Controls
• Use a risk-based graded approach that considers
  the toxicological and environmental data for all
  UNP
• Conduct work that could generate airborne UNP in
  a ventilated full or partial enclosure i.e.
  exhaust ventilation hood, glove bag, or glove box
  
• If the operation cant be enclosed, use alternate
  controls such as local exhaust ventilation
  (snorkels) to capture fugitive UNP at the
  source
• Ventilation systems that can produce blow back
  such as laminar flow hoods are not acceptable
• Enclosed systems under positive pressure must be
  used in a negative pressure enclosure and
  exhausted prior to opening glove box ?
• Assure appropriate controls are in place to
  exclude UNP from any exhaust air entering the
  work space biological safety cabinet or vacuum
  and release indoors
• Regularly test and maintain all ventilation
  systems used to control exposure to UNP according
  to prescribed procedures or the manufacturers
  recommendations

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Notice Requirements

• Posting Labeling
• Post hazards, PPE requirements, and
  administrative control requirements at entry
  points into designated areas where UNP are
  handled
• Designated area may be an entire laboratory, an
  area of a laboratory or a containment device
  such as a laboratory hood or glove box
• Where appropriate, label storage and transfer
  containers to indicate the contents include UNP,
  e.g., nanoscale ZnO particles instead of just ZnO
• The label on UNP moved or transferred outside of
  the laboratory must indicate that the material
  may be unusually reactive and vary in toxic
  potential, quantitatively and qualitatively, from
  macro size forms of the same material

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Notice Requirements

• Transportation
• Properly package, label, and provide safety
  information for the transport of all UNP
• When multiple layers of packaging are used, label
  the innermost receptacle or container with a
  label that communicates an appropriate level of
  caution and description of the contents

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Notice Requirements

• Waste Management
• Must have a documented procedure for how UNP
  waste is handled
• Include the storage and tracking of the waste
• To the extent possible, UNP waste shall be
  segregated from other waste
• Keep an inventory of all UNP waste that is
  shipped off site
• Description of the waste, including quantity
• Means and location of final disposition
• Notification of any appropriate environmental
  regulatory agency
• Follow all federal, state, and local disposal
  regulations
• If information on UNP hazards suggests that
  additional protective measures should be taken,
  then those measures will be identified and put
  into place

Contains Nanomaterials
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Unanswered Questions

• The notice leaves assessments and
  interpretations to the reader. This most likely
  will result in confusion and a variety of
  applications at various laboratories.
• An overall document for guidance is the NSRC
  Approach to Nanomaterial ESH. However, this
  guidance document allows for interpretation and
  does not detail specific actions to follow.
• The following is a list of questions that I feel
  should be answered specifically to provide
  consistent application and reporting to DOE.

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Unanswered Questions

• Under definition of Engineered Nanoparticle, it
  is unclear if the definition includes chemical
  molecules such as ligands and polymers, which are
  not biological molecules.
• There is no clear description of what information
  the personnel registry is to contain.
• There is no frequency at which the contractor is
  to provide medical services with a copy of the
  registry.
• There is no clear description of what information
  is to be included in the inventory of activities
  involving UNP.

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Unanswered Questions

• There is no clear description of the information
  to be included in the annual review of activities
  involving UNP.
• There is a requirement for inclusion of
  safeguards, security, and emergency management
  personnel. These are not nanoworkers by
  definition in the notice. Do they require the
  same level of training as nanoworkers?
• There is a requirement for the exposure
  assessment to assess the need for use of HEPA
  exhaust filtration. Since under the exposure
  assessment section, is assessment only for worker
  protection and not environmental?

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Unanswered Questions

• The notice requires the contractor to establish
  an air monitoring program based on the
  preliminary exposure assessment. If preliminary
  exposure assessment is negative is a monitoring
  program required?
• There is no definition of guest worker in the
  document. Does this apply to any nanomaterial
  worker who is not a paid employee of the
  contractor?
• Under the controls section there is a requirement
  for enclosed systems under positive pressure to
  be used in a negative pressure enclosure. Is the
  intention to mean a small apparatus that can
  easily fit inside a normal chemical hood or glove
  box?

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Unanswered Questions

• Exclude UNP from exhaust air entering the
  workplace. Does this mean recirculation of
  filtered air is acceptable?
• Post signs with three criteria hazard, PPE,
  admin controls. This could be three pages and
  well above any OSHA requirement. Could we simply
  have the experimental review document which
  details the controls available at the designated
  area?
• Label storage areas and transfer containers where
  appropriate. Do we need to label containers that
  are filled and closed in a hood and then taken 10
  feet and inserted into experimental equipment?

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Unanswered Questions

• There is a requirement to label with excessive
  information when transferring outside the
  laboratory. What does outside the laboratory
  mean? Moving materials from one lab to another
  down the hall, or down one floor, or from
  building to building?
• Properly package, label and provide safety info
  for transport. Who decides what proper is? If one
  lab sends to another they may not follow the same
  packaging requirements.
• There is no definition of what UNP waste is.
• There is a requirement to inventory, track and
  document quantity of UNP waste. There is no unit
  definition of quantity of waste. Is this mass or
  volume? What units?

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Audience Questions ??