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

1. Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories Deborah Gold, dgold@dir.ca.gov Bob Nakamura, bnakamura@dir.ca.gov October 2, 2009

2. “Every Employer shall furnish employment and a place of employment that is safe and healthful for the employees therein.” California Labor Code Section 6400

3. 6000 5000 4000 3000 2000 1000 0 1980 1982 1984 1986 1988 1990 1992 1994 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

4. Counties in CA with increased TB incidence 2007-2008 Source: CDPH

5. 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

7. 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.

8. 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 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

10. 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.

11. 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

12. 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

13. 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

14. 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)

15. 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

16. 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.

17. 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)

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

19. 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

20. 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

21. 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

22. 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

23. Vaccinations • 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

24. 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

25. 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

26. 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.

27. 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

28. 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

29. 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. • It’s our job.

30. H1N1 • Laboratory capacity was overwhelmed in the first month • Reduction in testing recommendations • Reduction in laboratory precautions

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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_committee.html