ATD Biosafety and Exposure Control Plan / 8
Aerosol Transmissible Diseases
Biosafety and Exposure Control Plan
To comply with Cal-OSHA Title 8, Section 5199 and 5199.1
Environmental Health and Safety, University of California Santa Barbara
For EH&S Use OnlyPathogens:
Biological Use Authorization #
Animal Care and Use Protocol #
Lab Inspection Date
Biosafety Officer Date
1. Contact Information
Principal Investigator Department
Phone Office
Co-Principal Investigator Department
Phone Office
2. Principal Investigator’s Certification
By signing below, I certify that I have read the following statements and I will comply with the conditions outlined in this plan. As the Principal Investigator I will
1) Ensure that all personnel involved in this project are adequately trained in safe laboratory practices for this protocol before any work begins on this project.
2) Ensure personnel who work with aerosol transmissible pathogens will be trained annually.
3) Follow the health surveillance practices as approved for this plan and inform personnel working on this project about emergency information.
4) Report to Business Services and EH&S any research-related accident or illness as soon as possible and no later than 24 hours after the occurrence.
5) Submit in writing any significant modifications made to this plan or the facility.
6) Read and understand the responsibilities of the Principal Investigator as stated in Cal-OSHA Title 8, Section 5199 (https://www.dir.ca.gov/Title8/5199.html).
Principal Investigator signature ______Date ______
Department Chair signature ______Date ______
3. Research Documentation
Biological Use Authorization # ______
Animal Care and Use Protocol # ______
List any other ancillary written standard operating procedures or documents
The document(s) above summarize the following research information:
· Personnel and job titles
· Research facilities, field sites and storage locations
· Scope of work
· Animal species studied
· Other (specify):
4. Exposure Determination
4A. Risk Assessment Summary
List the aerosol transmissible pathogens from Appendix D of the Cal-OSHA Title 8 Standard 5199 (https://www.dir.ca.gov/Title8/5199.html) that are studied in the laboratory and/or are reasonably likely to be encountered during the course of field research. Specify the source (commercial, collaborator, environmental, etc.) of the infectious agents. Summarize the agent(s), host and procedural factors associated with risk for research personnel. Some aspects to consider include infectious dose, agent stability, communicability, route of entry, severity of infection.
4B. Project-Specific Procedures
Identify all aerosol and droplet generating procedures performed with aerosol transmissible pathogen(s) and the means of containment.
5. Engineering Controls
5A. Negative Pressure
Airflow is exhausted 100% from all laboratories at UCSB. Negative pressure airflow shall be visually demonstrated daily while a room is in use for work with aerosol transmissible pathogens. Methods to verify negative pressure:
5B. Biosafety Cabinets
All open work with infectious agents and materials is conducted in a properly certified Biological Safety Cabinet.
Biosafety Cabinet / Date of Certification / Room #Class / Type
5C. Other
Specify other physical containment devices in use:
6. Safe Work Practices
6A. Safe Work Practices in the Laboratory
Practices for handling samples and specimens in the laboratory will follow the standards described in the Biosafety in Microbiological and Biomedical Laboratories, current edition, and supplemented by other practices as appropriate.
· The laboratory door and all equipment and storage sites where infectious materials may be present must be posted with signs incorporating the universal biohazard symbol. The entryway sign must include the following information:
o Biosafety level of the laboratory
o Supervisor or responsible individual’s name and complete contact information
o Biohazardous agent(s) in use in the laboratory (except select agents)
o Required procedures for entering and exiting the laboratory
· Access to the laboratory is controlled by written institutional and investigator policy.
· Universal Precautions are used for handling human and nonhuman primate blood or other potentially infectious materials
· Persons must wash their hands after working with potentially hazardous materials, after removing gloves, and before leaving the laboratory
· All freezers and refrigerators in the laboratory must be labeled to prohibit food storage
· Mechanical pipetting devices are to be used at all times
· Sharps including razor blades, scalpels, and hypodermic needles and other sharp instruments are limited to use only when there is no alternative
· Disposable sharps must be placed in hard-walled sharps waste containers designed and approved specifically for that purpose
· Non-disposable sharps must be transported to the autoclave in a hard-walled container for decontamination before further processing
· Broken glass must be picked up with broom or brush and dustpan, tongs, or forceps and disposed to a container approved for that use
· Perform all procedures in a manner that minimizes splashes or aerosols
· Perform all aerosol-generating procedures in a containment device such as a biological safety cabinet or a centrifuge with sealed rotors
· Other safe work practices specific to the laboratory:
Prohibited practices in all laboratories:
· Eating, drinking, handling contact lenses, and applying cosmetics in any laboratory Food storage in any refrigerator or freezer within the laboratory
· Mouth pipetting
· Altering or removing hypodermic needles from disposable syringes
· Placing head within biosafety cabinet
· Sniffing cultures or samples
· Other prohibited work practices specific to the laboratory:
6B. Safe Work Practices in the Field
· Handling is minimized to avoid being bitten or scratched by wild animals.
· Special precautions are taken to ensure human safety when transporting taxa known or suspected of carrying potential zoonoses.
· Other safe work practices specific to this field work:
7. Personal Protective Equipment (PPE):
Check PPE to be used when working with and near potential aerosol transmissible pathogens.
Lab coat / Shoe coveringsClosed front gown/coverall / Other:
Single latex/nitrile gloves
Double latex/nitrile gloves / Respirator
Bite resistant gloves / Disposable N95 particulate respirator
Goggles / PAPR
Face shield
List operations or conditions that require use of respirators:
8. Disinfection and Sterilization
8A. Spill Response and Emergency Procedures for Uncontrolled Releases
Uncontrolled releases within the laboratory facility and untreated releases outside the laboratory facility shall be reported to the local health officer (§5199 f.4.J).
Describe the emergency response actions, including evacuation, follow up from outside the laboratory, and disinfection after the emergency is resolved.
Indicate the disinfectant to be used along with the contact time.
8B. Surface Decontamination
Work surfaces will be decontaminated with an approved disinfectant at least once per day, after work is completed for the day, and after any spill or splash of infectious material. Check the chemical disinfectants available in the laboratory and indicate which disinfectant(s) is used for general surface decontamination.
Describe decontamination procedures for lab equipment as applicable.
Equipment / Decontamination ProceduresBiosafety Cabinet
Centrifuge
Flow cytometer
Incubator
Other:
Other:
Other:
Other:
8C. Liquid Waste Disinfection and Disposal
All cultures, stocks, and other regulated liquid waste will be decontaminated before disposal by addition of bleach to a 10% final bleach concentration in the contaminated liquid and 30 minutes minimum contact time. The vacuum line(s) used for aspirating liquid waste is protected by a HEPA filter and a secondary flask. Decontaminated material may be disposed in the sink, followed by a water rinse sufficient to flush all of the decontaminated material down the drain.
Indicate the disinfectant(s) used for decontaminating liquid waste
0.5% Sodium hypochlorite (10% bleach) / OtherProvide a brief description of the disinfection procedure. Include the disinfectant concentration and contact time with liquid waste.
8D. Solid Waste Disinfection and Disposal
Solid biohazardous waste must be deactivated via steam sterilization at a minimum of 121˚C at 15 psi for 30 minutes. Alternatively, a commercial medical waste vendor may be designated to transport and deactivate waste.
Provide a brief description of the solid waste produced.
Indicate the methods(s) used to disinfect and dispose of solid waste.
Autoclave/Steam sterilizationCommercial medical waste service / Company Name:
9. Medical Surveillance and Post-Exposure Follow-up
All individuals who work with the covered aerosol transmissible agents must participate in a health surveillance program specific to the hazards of the agents and the research being conducted. Persons with special health concerns such as pregnant women or immunocompromised individuals are encouraged to self-identify to their healthcare provider or an occupational health physician and will receive special counseling on work.
Medical surveillance procedures:
Symptoms of infection:
Recommended vaccinations:
Brief description of medical follow-up for employees who experience exposure to ATP-L used in this laboratory:
1. Clean the affected area. Wash needlesticks and cuts with soap and water, flush splashes to the nose, mouth, or skin with water, and irrigate eyes with clean water, sterile saline. The laboratory sink, emergency shower and eye wash stations will be used as necessary to flush affected areas with water for several minutes.2. Report the incident. The exposure must be reported to the PI or Lab Safety Contact immediately. Employees and personnel on University pay status must call the UC Work Comp Injury Line at 1-877-682-7778 to report the incident and complete the Incident Report Form http://www.workcomp.ucsb.edu/Incident_Report_Form.pdf.
3. Seek treatment. Healthcare personnel treating exposed patients must be informed of the biological materials involved in the exposure. Students will be directed to seek treatment at UCSB Student Health Services, Building 588, at El Colegio and Ocean Road, Santa Barbara CA 93117. Employees and personnel on University pay status will fax the Incident Report Form to the UCSB Workers’ Compensation Office at x 8521, and the UCSB Workers’ Compensation Officer at x 8050 will arrange for treatment at Sansum Occupational Medicine Center, 101 South Patterson, Santa Barbara, CA 93111. Students and employees may seek treatment after hours at Sansum Urgent Care Center, 51 Hitchcock Way, Santa Barbara, CA 93105.
4. Document the incident. The post-exposure evaluation will include an explanation of the circumstances, route of exposure and type of inoculum. All percutaneous injuries from contaminated sharps will be recorded on the OSHA 300 Log and the Sharps Injury Log.
5. State other personnel decontamination procedures as appropriate:
10. Shipping and Receiving
All incoming packages containing ATP-L will be treated as though they contain virulent or wild-type pathogen until verified at the laboratory that a pathogen has been deactivated or attenuated. The unopened package exterior shall be inspected for integrity, and then wiped down or sprayed with 0.5% sodium hypochlorite (10% bleach). The package shall be opened inside a biosafety cabinet to ensure worker protection.
Other standard operating procedures for the receipt of packages containing ATP-L:
11. Recordkeeping
11A. Disease Control Plan Implementation
The Principal Investigator shall establish and maintain records of implementation of the exposure control plan and/or zoonotic disease control procedures in accordance with (§5199 e). This document may serve as a record of implementation of hazard identification, evaluation and control, and employee training (see below).
11B. Annual Training and Review
Annual training and review must be documented. Annual training to the exposure control procedures described herein and in your BUA and/or IACUC protocols is required of all personnel working with pathogens or wildlife potentially harboring aerosol transmissible zoonoses. Refresher training shall be conducted yearly. Training records shall be maintained for three (3) years from the date on which the training occurred (§5199 j.2.A).
The Principal Investigator (PI) is ultimately responsible for conducting the training and responding to questions. The PI may designate a laboratory manager or supervisor to conduct the training.
If someone other than the PI will conduct the training, specify the trainer’s name, job title, and qualifications.
Evaluation of this plan shall be performed annually and documented in writing (§5199 j.3.A).
Employees shall be involved in the evaluation of the effectiveness of this exposure control plan. Employees may evaluate this plan after their initial training.
Attach a roster or expand the table below as necessary to provide for the printed name, job title, signature and date of review for all personnel listed in your IACUC protocol.
Training and Review of the ATD Biosafety and Exposure Control Plan
Name / Job Title / Signature / Date of ReviewRevised August 2012