Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories

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Update Application of Cal/OSHA Aerosol
Transmissible Disease Standards in Laboratories

• Deborah Gold, dgold_at_dir.ca.gov
• Bob Nakamura, bnakamura_at_dir.ca.gov
• October 2, 2009

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Every Employer shall furnish employment and a
place of employment that is safe and healthful
for the employees therein. California Labor Code
Section 6400
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Tuberculosis Cases in California, 1980-2008
TB Incidence still well over national average
rate of decline has slowed.
CDPH
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Counties in CA with increased TB incidence
2007-2008
Source CDPH
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Why an ATD standard

• Existing aerosol transmissible diseases such as
  TB health care workers still at increased risk
• Experience of Canada and Asia with SARS
• Planning for pandemic flu and other surge events
• Incidents of laboratory transmission and near
  misses
• Increased research on BSL 3 and above

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Four Types of Employers

• Hospitals, other work settings which perform
• evaluation, diagnosis, treatment, transport,
  housing or management of persons requiring
  airborne infection isolation
• high hazard procedures performed on suspect or
  confirmed cases
• decontamination or management of persons
  contaminated as a result of a release of
  biological agents
• autopsies or embalming procedures on human
  cadavers potentially infected with aerosol
  transmissible pathogens.

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Four Types of Employers (cont)

• Patients or clients are screened for airborne
  infectious diseases and referred if indicated
  (Referring Employers subsection (c))
• Laboratories (subsection (f))
• Conditionally Exempt Employers medical
  specialty practices, dentists that dont treat
  ATDs, dont perform high hazard procedures on
  those patients, and have screening and referral
  procedures
• Separate subsections allow people to focus on
  requirements that apply to them

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Laboratory Subsection

• Control of person to person transmission is
  different than laboratory aerosols.
• Infectious organisms may become airborne in labs
  that are not naturally transmitted by that route.
• Biosafety professionals have already established
  consensus guidelines, e.g. BMBL
• We want to prevent an increase in laboratory
  risks due to increasing research on emerging
  pathogens and homeland security issues.

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Some Recent Lab Exposures

• Brucellosis in clinical lab worker in southern
  California
• Anthrax at research facility
• TB conversions related to exposure chamber
• Inadvertent distribution of H2N2 influenza virus
• Tularemia

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Aerosol Transmissible Pathogens Laboratory

• Listed in Appendix D
• List derived from BMBL and HICPAC guidelines
• BMBL recommends BSL 3 or above
• Biosafety Officer recommends
• Novel or Unknown Pathogen

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Novel or Unknown Pathogen

• Causes serious human disease
• Credible evidence that the pathogen is
  transmissible to humans by aerosols
• The disease agent is
• (a) A newly recognized pathogen, or
• (b) A newly recognized variant that differs
  significantly in virulence or transmissibility,
  or
• (c) A recognized pathogen that has been recently
  introduced into the human population, or
• (d) A not yet identified pathogen.
• Pandemic flu strain is a novel pathogen, seasonal
  influenza is not

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Laboratories -- Application

• Laboratories that perform procedures that
  aerosolize ATPs-L
• If employees have direct contact with infectious
  people (cases or suspected cases), other sections
  also apply.
• The presence of ATPs-L requires the development
  of a biosafety plan (institutional risk
  assessment)

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Risk Assessment

• Done by a biosafety officer
• Consistent with BMBL, Section II
• For each agent and procedure
• Record safe handling practices in biosafety plan
• Trade secret info need not be recorded in plan
• Control measures consistent with risk

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Zoonotics Section 5199.1

• Applies to any place where employees are exposed
  to animals, or their products or wastes
• Under normal circumstances address under IIPP
  (Section 3203)
• Existing BBP regulation applies to animals
  infected with BBP
• Existing respiratory protection standard (5144)
  applies to exposures to infectious aerosols.

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Risk Assessment VivariumsSection 5199.1

• Applies to all vertebrate animal research
  facilities
• Risk assessment and control consistent with BMBL
• BMBL references NIH and ILAR guidelines for
  general conditions in anitmal facilities
• Tissues and samples to comply with ATD standard,
  section 5199(f)

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Hierarchy of Controls

• Engineering
• Use alternative processes
• Primary and secondary containment
• Work Practices
• Personal and Respiratory Protection, if necessary
• Consistent with BMBL

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Biosafety Officers Are Key

• Assess risk and specify control measures based on
  the specific pathogens and processes in the lab
• Must have necessary knowledge, authority and
  responsibility
• Audit and correct hazards
• Review the plan
• Be consulted regarding changes to facility that
  would effect biosafety

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Elements of Biosafety Plan (1)

• Lists of jobs, tasks, procedures, ATPs-L
• Requirement to treat incoming materials as
  containing virulent pathogen until verify
  attenuated
• Engineering controls (e.g. laboratory
  construction, biosafety cabinets)
• Safe handling procedures
• Decontamination and disinfection
• PPE and Respirators if necessary

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Elements of Biosafety Plan (2)

• Emergency procedures, including report to local
  health officer
• Medical services
• Training
• Employee involvement in review of plan
• Inspection procedures and hazard correction
• BSO to review design and construction plans for
  review of ATPs-L control

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Medical Services

• Vaccinations
• Exposure incidents notification and medical
  follow-up
• LTBI surveillance not required in research labs
  not working with materials reasonably anticipated
  to contain TB
• Respirator evaluations, if applicable
• Ensure confidentiality

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Vaccinations

• Health Care Workers MMR, Tdap, Varicella,
  influenza (HBV per 5193)
• Laboratory workers pathogen/material/risk-benefi
  t based on BMBL/ACIP recommendations
• BMBL recommends medical consultation for
  employees at BSL 3 and above
• Seasonal flu effective now
• Other vaccination requirements effective
  September 1, 2010

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Recordkeeping

• Medical records including vaccination, LTBI as
  applicable
• Training
• Plan review
• Inspection and testing of engineering controls,
  such as ventilation systems and biosafety
  cabinets
• Respiratory Protection per 5144

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IIPP

• Written health and safety program
• Responsible person
• System of compliance with safety rules
• Hazard Identification/Evaluation and Correction
• Communication
• Accident/illness investigation
• Training
• Recordkeeping

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Zoonotics

• Subsection (c) applies to animals under
  quarantine order etc. from USDA, CDFA
• Requires use of respirators and change rooms when
  entering enclosed areas.
• Subsection (d) applies to eradication and clean
  up operations, disinfection of areas containing
  wastes from animals infected with zoonotic ATPs.

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Vertebrate Animal Research Facilities ABSL 3 or
above

• MUST Comply with Subsection (d)
• Written work plan, assessment of all risks
  (including chemical, physical and safety hazards)
  and control measures
• Restricted areas
• Contaminant reduction zone
• Supervision
• Recording of entry

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Vertebrate Animal Research Facilities ABSL 3 or
above (cont)

• Respirators
• Decontamination, disposal
• Change facilities
• Medical services
• Procedures for access to drinking water and
  sanitation facilities
• Training
• Procedures for toxic or asphyxiant gases, if
  applicable

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Why is Cal/OSHA in My Lab?

• Cal/OSHA is the agency designated by law to
  protect employees at work
• Cal/OSHA provides a way for employees to get an
  independent review of safety issues at work, and
  to get hazards corrected in a timely manner
• Cal/OSHA experience is that NIH guidelines and
  other audit programs do not prevent significant
  failures in occupational health and safety
  programs.
• Its our job.

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H1N1

• Laboratory capacity was overwhelmed in the first
  month
• Reduction in testing recommendations
• Reduction in laboratory precautions

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Interim Biosafety Guidance 2009-H1N1 Influenza A
Virus CDC 8-15-09

1. Splash Protection for performing rapid
   immunoassay tests
2. Class II biosafety cabinet (BSC) in BSL-2 lab for
   more complex procedures (e.g., direct or indirect
   fluorescent antibody tests DFA, IFA, culture,
   molecular assays), a Class II biosafety cabinet
   (BSC) in a biosafety level-2 (BSL-2) laboratory
   is required. 
3. BSL-3 practices are no longer required for viral
   isolation. 
4. Personal Protective Equipment -- lab coats and
   gloves

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Rapid Tests lab or non-lab settings

• FDA-cleared rapid immunoassay tests require
  assessment of risks for generation of aerosols or
  contact with infectious material.
• If they do not generate aerosols, they require
  splash protection laboratory coat, gloves, eye
  protection, facemask
• Procedures done outside a Class II BSC should be
  performed to minimize creation of splashes and/or
  aerosols.
• Aerosol generating tests BSL-2

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Procedures Requiring BSL-2

• Rapid tests involving steps that could generate
  aerosols (e.g. vortexing),
• Direct or indirect fluorescent antibody tests
  (DFA, IFA) to detect viral antigens in clinical
  specimens,
• Growth of virus in cell culture or embryonated
  eggs,
• Molecular-based assays,
• General laboratory research
• Viral isolation and all sample manipulations with
  the potential for creating an aerosol in Class II
  BSC

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Occupational Health

• Personnel who have had an occupational exposure
  to any infectious agent, including 2009-H1N1
  influenza A (novel H1N1), should immediately
  inform their supervisor or manager.  Antiviral
  chemoprophylaxis is available and should be
  considered.  For additional information on
  antiviral treatment visit Interim Guidance on
  Antiviral Recommendations for Patients with
  Confirmed or Suspected Swine Influenza A (H1N1)
  Virus Infection and Close Contacts

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Benefits of Lab Section

• Supports the role of biosafety professionals in
  labs, including risk analysis
• Establishes a baseline level of safety and works
  against cutting safety to compete for contracts
  etc.
• Is structured to incorporate existing biosafety
  guidelines, procedures, plans
• Provides notice to employers and employees
  regarding Cal/OSHA requirements helps us all be
  on the same page

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Find Cal/OSHA on the Web

• Cal/OSHA regulations
• http//www.dir.ca.gov/samples/search/query.htm
• Standards Board Proposed Regulations
• http//www.dir.ca.gov/oshsb/atdapprvdtxt.pdf
• Advisory committee webpage
• http//www.dir.ca.gov/dosh/DoshReg/advisory_commit
  tee.html