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Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories. Deborah Gold, [email protected] Bob Nakamura, [email protected] October 2, 2009.

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Update application of cal osha aerosol transmissible disease standards in laboratories l.jpg

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

Deborah Gold, [email protected]

Bob Nakamura, [email protected]

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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6000 employment that is safe and healthful for the employees therein.”

5000

4000

3000

2000

1000

0

1980

1982

1984

1986

1988

1990

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1996

1998

2000

2002

2004

2006

2008

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 employment that is safe and healthful for the employees therein.”

Source: CDPH


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Why an ATD standard employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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) employment that is safe and healthful for the employees therein.”

  • 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 don’t treat ATDs, don’t 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 – Vivariums employment that is safe and healthful for the employees therein.”Section 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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) employment that is safe and healthful for the employees therein.”

  • 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) employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • Health Care Workers – MMR, Tdap, Varicella, influenza (HBV per 5193)

  • Laboratory workers – pathogen/material/risk-benefit based on BMBL/ACIP recommendations

  • BMBL recommends medical consultation for employee’s at BSL 3 and above

  • Seasonal flu effective now

  • Other vaccination requirements effective September 1, 2010


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Recordkeeping employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

  • 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 employment that is safe and healthful for the employees therein.”

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? (cont)

  • 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.

  • It’s our job.


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H1N1 (cont)

  • 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

Splash Protection for performing rapid immunoassay tests

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. 

BSL-3 practices are no longer required for viral isolation. 

Personal Protective Equipment -- lab coats and gloves


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Rapid Tests: lab or non-lab settings 8-15-09

  • 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 8-15-09

  • 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 8-15-09

  • 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 8-15-09

  • 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 8-15-09

  • 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_committee.html


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