Update: Application of Update: Application of Cal/OSHA Aerosol Cal/OSHA Aerosol

Transmissible Disease Transmissible Disease Standards in LaboratoriesStandards in Laboratories

Deborah Gold, Deborah Gold, dgold@dir.ca.govdgold@dir.ca.gov Bob Nakamura, Bob Nakamura,

bnakamura@dir.ca.govbnakamura@dir.ca.govOctober 2, 2009October 2, 2009

“Every Employer shall furnish employment and a place of employment that is safe and healthful for the employees therein.”

California Labor Code Section 6400

Tuberculosis Cases in California, Tuberculosis Cases in California, 1980-20081980-2008

0

1000

2000

3000

4000

5000

6000

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

TB Incidence still well over national average; rate of decline has slowed.

CDPH

Counties in CA Counties in CA with increased TB with increased TB incidence 2007-incidence 2007-

20082008Contra Costa

San Joaquin

Tulare

San BernardinoVentura

Santa Barbara

Stanislaus

Kern

PasadenaLong Beach

Contra Costa

San Joaquin

Tulare

San BernardinoVentura

Santa Barbara

Stanislaus

Kern

PasadenaLong Beach

Source: CDPH

Why an ATD standardWhy an ATD standard

Existing aerosol transmissible diseases Existing aerosol transmissible diseases such as TB – health care workers still at such as TB – health care workers still at increased riskincreased risk

Experience of Canada and Asia with SARSExperience of Canada and Asia with SARS

Planning for pandemic flu and other surge Planning for pandemic flu and other surge eventsevents

Incidents of laboratory transmission and Incidents of laboratory transmission and near missesnear misses

Increased research on BSL 3 and aboveIncreased research on BSL 3 and above

Four Types of EmployersFour Types of Employers

A.A. Hospitals, other work settings which perform:Hospitals, other work settings which perform:– evaluation, diagnosis, treatment, transport, housing evaluation, diagnosis, treatment, transport, housing

or management of persons requiring airborne or management of persons requiring airborne infection isolation; infection isolation;

– high hazard procedures performed on suspect or high hazard procedures performed on suspect or confirmed cases; confirmed cases;

– decontamination or management of persons decontamination or management of persons contaminated as a result of a release of biological contaminated as a result of a release of biological agents; agents;

– autopsies or embalming procedures on human autopsies or embalming procedures on human cadavers potentially infected with aerosol cadavers potentially infected with aerosol transmissible pathogens. transmissible pathogens.

Four Types of Employers (cont)Four Types of Employers (cont)

B.B. Patients or clients are screened for Patients or clients are screened for airborneairborne infectious diseases and referred if indicated infectious diseases and referred if indicated (Referring Employers – subsection (c))(Referring Employers – subsection (c))

C.C. Laboratories Laboratories (subsection (f))(subsection (f))D.D. Conditionally Exempt Employers – medical Conditionally Exempt Employers – medical

specialty practices, dentists that don’t treat specialty practices, dentists that don’t treat ATDs, don’t perform high hazard procedures ATDs, don’t perform high hazard procedures on those patients, and have screening and on those patients, and have screening and referral procedures; referral procedures;

Separate subsections allow people to focus on Separate subsections allow people to focus on requirements that apply to themrequirements that apply to them

Laboratory SubsectionLaboratory Subsection

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

Some Recent Lab ExposuresSome Recent Lab Exposures

Brucellosis in clinical lab worker in Brucellosis in clinical lab worker in southern California southern California

Anthrax at research facilityAnthrax at research facility

TB conversions related to exposure TB conversions related to exposure chamber chamber

Inadvertent distribution of H2N2 influenza Inadvertent distribution of H2N2 influenza virusvirus

Tularemia Tularemia

Aerosol Transmissible Pathogens Aerosol Transmissible Pathogens LaboratoryLaboratory

Listed in Appendix DListed in Appendix D– List derived from BMBL and HICPAC List derived from BMBL and HICPAC

guidelines guidelines

BMBL recommends BSL 3 or aboveBMBL recommends BSL 3 or above

Biosafety Officer recommendsBiosafety Officer recommends

Novel or Unknown PathogenNovel or Unknown Pathogen

Novel or Unknown PathogenNovel or Unknown PathogenCauses serious human diseaseCauses serious human diseaseCredible evidence that the pathogen is Credible evidence that the pathogen is transmissible to humans by aerosolstransmissible to humans by aerosolsThe disease agent is:The disease agent is:– (a) A newly recognized pathogen, or(a) A newly recognized pathogen, or– (b) A newly recognized variant that differs significantly (b) A newly recognized variant that differs significantly

in virulence or transmissibility, or in virulence or transmissibility, or – (c) A recognized pathogen that has been recently (c) A recognized pathogen that has been recently

introduced into the human population, or introduced into the human population, or – (d) A not yet identified pathogen. (d) A not yet identified pathogen.

Pandemic flu strain is a novel pathogen, Pandemic flu strain is a novel pathogen, seasonal influenza is notseasonal influenza is not

Laboratories -- ApplicationLaboratories -- Application

Laboratories that perform procedures that Laboratories that perform procedures that aerosolize ATPs-Laerosolize ATPs-L

If employees have direct contact with If employees have direct contact with infectious people (cases or suspected infectious people (cases or suspected cases), other sections also apply.cases), other sections also apply.

The presence of ATPs-L requires the The presence of ATPs-L requires the development of a biosafety plan development of a biosafety plan (institutional risk assessment)(institutional risk assessment)

Risk AssessmentRisk Assessment

Done by a biosafety officerDone by a biosafety officer

Consistent with BMBL, Section IIConsistent with BMBL, Section II

For each agent and procedureFor each agent and procedure

Record safe handling practices in Record safe handling practices in biosafety plan biosafety plan

Trade secret info need not be recorded in Trade secret info need not be recorded in planplan

Control measures consistent with risk Control measures consistent with risk

Zoonotics – Section 5199.1Zoonotics – Section 5199.1

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

Risk Assessment – VivariumsRisk Assessment – VivariumsSection 5199.1Section 5199.1

Applies to all vertebrate animal research Applies to all vertebrate animal research facilitiesfacilities

Risk assessment and control consistent Risk assessment and control consistent with BMBLwith BMBL

BMBL references NIH and ILAR guidelines BMBL references NIH and ILAR guidelines for general conditions in anitmal facilitiesfor general conditions in anitmal facilities

Tissues and samples to comply with ATD Tissues and samples to comply with ATD standard, section 5199(f)standard, section 5199(f)

Hierarchy of ControlsHierarchy of Controls

EngineeringEngineering– Use alternative processesUse alternative processes– Primary and secondary containmentPrimary and secondary containment

Work PracticesWork Practices

Personal and Respiratory Protection, if Personal and Respiratory Protection, if necessarynecessary

Consistent with BMBLConsistent with BMBL

Biosafety Officers Are KeyBiosafety Officers Are Key

Assess risk and specify control measures Assess risk and specify control measures based on the specific pathogens and based on the specific pathogens and processes in the labprocesses in the labMust have necessary knowledge, authority Must have necessary knowledge, authority and responsibilityand responsibilityAudit and correct hazardsAudit and correct hazardsReview the planReview the planBe consulted regarding changes to facility Be consulted regarding changes to facility that would effect biosafetythat would effect biosafety

Elements of Biosafety Plan (1)Elements of Biosafety Plan (1)Lists of jobs, tasks, procedures, ATPs-LLists of jobs, tasks, procedures, ATPs-L

Requirement to treat Requirement to treat incomingincoming materials materials as containing virulent pathogen until verify as containing virulent pathogen until verify attenuatedattenuated

Engineering controls (e.g. laboratory Engineering controls (e.g. laboratory construction, biosafety cabinets)construction, biosafety cabinets)

Safe handling proceduresSafe handling procedures

Decontamination and disinfectionDecontamination and disinfection

PPE and Respirators if necessaryPPE and Respirators if necessary

Elements of Biosafety Plan (2)Elements of Biosafety Plan (2)Emergency procedures, including report to Emergency procedures, including report to local health officerlocal health officer

Medical services Medical services

TrainingTraining

Employee involvement in review of planEmployee involvement in review of plan

Inspection procedures and hazard Inspection procedures and hazard correctioncorrection

BSO to review design and construction BSO to review design and construction plans for review of ATPs-L control plans for review of ATPs-L control

Medical ServicesMedical Services

Vaccinations Vaccinations

Exposure incidents – notification and Exposure incidents – notification and medical follow-upmedical follow-up

LTBI surveillance – not required in LTBI surveillance – not required in research labs not working with materials research labs not working with materials reasonably anticipated to contain TBreasonably anticipated to contain TB

Respirator evaluations, if applicableRespirator evaluations, if applicable

Ensure confidentialityEnsure confidentiality

VaccinationsVaccinations

Health Care Workers – MMR, Tdap, Health Care Workers – MMR, Tdap, Varicella, influenza (HBV per 5193)Varicella, influenza (HBV per 5193)Laboratory workers – Laboratory workers – pathogen/material/risk-benefit based on pathogen/material/risk-benefit based on BMBL/ACIP recommendations BMBL/ACIP recommendations BMBL recommends medical consultation BMBL recommends medical consultation for employee’s at BSL 3 and abovefor employee’s at BSL 3 and aboveSeasonal flu effective nowSeasonal flu effective nowOther vaccination requirements effective Other vaccination requirements effective September 1, 2010September 1, 2010

RecordkeepingRecordkeeping

Medical records including vaccination, Medical records including vaccination, LTBI as applicableLTBI as applicable

TrainingTraining

Plan reviewPlan review

Inspection and testing of engineering Inspection and testing of engineering controls, such as ventilation systems and controls, such as ventilation systems and biosafety cabinetsbiosafety cabinets

Respiratory Protection per 5144Respiratory Protection per 5144

IIPPIIPP

Written health and safety programWritten health and safety programResponsible personResponsible personSystem of compliance with safety rulesSystem of compliance with safety rulesHazard Identification/Evaluation and Hazard Identification/Evaluation and CorrectionCorrectionCommunicationCommunicationAccident/illness investigationAccident/illness investigationTrainingTrainingRecordkeepingRecordkeeping

ZoonoticsZoonotics

Subsection (c) applies to animals under Subsection (c) applies to animals under quarantine order etc. from USDA, CDFAquarantine order etc. from USDA, CDFA

Requires use of respirators and change Requires use of respirators and change rooms when entering enclosed areas.rooms when entering enclosed areas.

Subsection (d) applies to eradication and Subsection (d) applies to eradication and clean up operations, disinfection of areas clean up operations, disinfection of areas containing wastes from animals infected containing wastes from animals infected with zoonotic ATPs. with zoonotic ATPs.

Vertebrate Animal Research Vertebrate Animal Research Facilities – ABSL 3 or aboveFacilities – ABSL 3 or above

MUST Comply with Subsection (dMUST Comply with Subsection (d))

Written work plan, assessment of all risks Written work plan, assessment of all risks (including chemical, physical and safety (including chemical, physical and safety hazards) and control measureshazards) and control measures

Restricted areasRestricted areas

Contaminant reduction zoneContaminant reduction zone

SupervisionSupervision

Recording of entryRecording of entry

Vertebrate Animal Research Vertebrate Animal Research Facilities – ABSL 3 or above (cont)Facilities – ABSL 3 or above (cont)

RespiratorsRespirators

Decontamination, disposalDecontamination, disposal

Change facilitiesChange facilities

Medical servicesMedical services

Procedures for access to drinking water Procedures for access to drinking water and sanitation facilitiesand sanitation facilities

TrainingTraining

Procedures for toxic or asphyxiant gases, Procedures for toxic or asphyxiant gases, if applicableif applicable

Why is Cal/OSHA in My Lab?Why is Cal/OSHA in My Lab?Cal/OSHA is the agency designated by law Cal/OSHA is the agency designated by law to protect employees at workto protect employees at workCal/OSHA provides a way for employees Cal/OSHA provides a way for employees to get an independent review of safety to get an independent review of safety issues at work, and to get hazards issues at work, and to get hazards corrected in a timely mannercorrected in a timely mannerCal/OSHA experience is that NIH Cal/OSHA experience is that NIH guidelines and other audit programs do not guidelines and other audit programs do not prevent significant failures in occupational prevent significant failures in occupational health and safety programs. health and safety programs. It’s our job. It’s our job.

H1N1H1N1

Laboratory capacity was overwhelmed in Laboratory capacity was overwhelmed in the first monththe first month

Reduction in testing recommendationsReduction in testing recommendations

Reduction in laboratory precautionsReduction in laboratory precautions

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

09091.1. Splash Protection for performing rapid Splash Protection for performing rapid

immunoassay tests immunoassay tests 2.2. Class II biosafety cabinet (BSC) in BSL-2 Class II biosafety cabinet (BSC) in BSL-2

lab for more complex procedures (e.g., lab for more complex procedures (e.g., direct or indirect fluorescent antibody tests direct or indirect fluorescent antibody tests [DFA, IFA], culture, molecular assays), a [DFA, IFA], culture, molecular assays), a Class II biosafety cabinet (BSC) in a Class II biosafety cabinet (BSC) in a biosafety level-2 (BSL-2) laboratory is biosafety level-2 (BSL-2) laboratory is required.  required. 

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

4.4. Personal Protective Equipment -- lab Personal Protective Equipment -- lab coats and glovescoats and gloves

Rapid Tests: lab or non-lab settingsRapid Tests: lab or non-lab settings

FDA-cleared rapid immunoassay tests FDA-cleared rapid immunoassay tests require assessment of risks for generation of require assessment of risks for generation of aerosols or contact with infectious material. aerosols or contact with infectious material.

If they do not generate aerosols, they require If they do not generate aerosols, they require splash protection: laboratory coat, gloves, splash protection: laboratory coat, gloves, eye protection, facemaskeye protection, facemask

Procedures done outside a Class II BSC Procedures done outside a Class II BSC should be performed to minimize creation of should be performed to minimize creation of splashes and/or aerosols.splashes and/or aerosols.

Aerosol generating tests: BSL-2Aerosol generating tests: BSL-2

Procedures Requiring BSL-2 Procedures Requiring BSL-2 Rapid tests involving steps that could generate Rapid tests involving steps that could generate aerosols (e.g. vortexing), aerosols (e.g. vortexing), Direct or indirect fluorescent antibody tests Direct or indirect fluorescent antibody tests (DFA, IFA) to detect viral antigens in clinical (DFA, IFA) to detect viral antigens in clinical specimens, specimens, Growth of virus in cell culture or embryonated Growth of virus in cell culture or embryonated eggs, eggs, Molecular-based assays, Molecular-based assays, General laboratory researchGeneral laboratory researchViral isolation and all sample manipulations with Viral isolation and all sample manipulations with the potential for creating an aerosol in Class II the potential for creating an aerosol in Class II BSCBSC

Occupational HealthOccupational Health

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

Benefits of Lab SectionBenefits of Lab SectionSupports the role of biosafety professionals in Supports the role of biosafety professionals in labs, including risk analysislabs, including risk analysis

Establishes a baseline level of safety and works Establishes a baseline level of safety and works against cutting safety to compete for contracts against cutting safety to compete for contracts etc.etc.

Is structured to incorporate existing biosafety Is structured to incorporate existing biosafety guidelines, procedures, plansguidelines, procedures, plans

Provides notice to employers and employees Provides notice to employers and employees regarding Cal/OSHA requirements – helps us all regarding Cal/OSHA requirements – helps us all be on the same pagebe on the same page

Find Cal/OSHA on the WebFind Cal/OSHA on the Web

Cal/OSHA regulations: Cal/OSHA regulations: – http://www.dir.ca.gov/samples/search/query.htmhttp://www.dir.ca.gov/samples/search/query.htm

Standards Board Proposed Regulations:Standards Board Proposed Regulations:

http://www.dir.ca.gov/oshsb/atdapprvdtxt.pdfhttp://www.dir.ca.gov/oshsb/atdapprvdtxt.pdf

Advisory committee webpage:Advisory committee webpage:– http://www.dir.ca.gov/dosh/DoshReg/http://www.dir.ca.gov/dosh/DoshReg/

advisory_committee.htmladvisory_committee.html