1 Exposure Control Plan Brown University’s Institutional Biosafety Committee, along with the Office of Environmental Health and Safety, has developed a template Exposure Control Plan (ECP) for all Biological Research Authorizations and Biological Safety Manuals. The Laboratory Supervisor must read the ECP template and carefully fill out key components specific to the protocol in which it belongs. In some cases one ECP may be thorough enough to be used for more than one protocol however, ALL ECP’s must be reviewed and updated annually and when necessary (i.e., a change of agent, procedure, location, or staff). Please contact Brown University’s Biological Safety Officer for assistance at 401-863-3353. Created: November 2011 Reviewed: June 2012 2 Exposure Control Plan (ECP) POLICY Brown University is committed to providing a safe and healthful work environment for faculty, students, and staff. In pursuit of this goal, the following Exposure Control Plan (ECP) is provided to assist researchers in developing procedures to eliminate or minimize occupational exposure to biological hazards and bloodborne pathogens in accordance with the Institutional Biosafety Committee (IBC) and OSHA standards. This ECP includes: Determination of researcher exposure Implementation of various methods of exposure control, including: Universal precautions Engineering and administrative controls Personal protective equipment Hepatitis B vaccination Disinfection/sterilization Housekeeping Post-exposure evaluation and follow-up Recordkeeping Communication of hazards to visitors/contractors and training Implementation methods for these elements of the standard are discussed in the subsequent pages of this ECP. Please Note: Where biological research is conducted with hazardous chemicals, the Chemical Hygiene Plan and Lab Safety Manual shall be used according to the policies discussed in Laboratory Safety Training. PROGRAM ADMINISTRATION The Laboratory Supervisor (listed below) is responsible for implementation of the ECP in location(s) covered by the plan, will maintain, review and update the ECP at least annually, and whenever necessary to include new or modified tasks and procedures. Laboratory Supervisor Name/Research Location: Title of the protocol covered by this ECP: Authorization number of the protocol covered by this ECP: Contact Number (include area code): Created: November 2011 Reviewed: June 2012 3 24-Hour Contact Number (mobile/home): IMPORTANT! All procedures associated with the specific Biological Research Authorization for which this ECP has been created must be attached along with the ECP (i.e., cell culture procedures, injection procedures, etc.) RESEARCER EXPOSURE DETERMINATION The following is a list of all laboratory personnel who perform tasks and procedures in which occupational exposure may occur and who must comply with all provisions outlined in this Exposure Control Plan. Name/Job Title (example: John Smith, Research Asst.) Department/Laboratory Location (example: MCB/BMC 864) Task/Procedure where occupational exposure may occur (example: Cell injection in live mice) METHODS OF IMPLEMENTATION AND CONTROL Universal Precautions Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Even when working with biological substances believed not to be infectious, researchers shall use universal precautions. Exposure Control Plan Training Created: November 2011 Reviewed: June 2012 4 In addition to completion of Brown University EHS Biological Safety Training and Bloodborne Pathogen (BBP) Training, researchers shall read and understand the specific ECP for the protocol on which they are assigned. Engineering Controls and Administrative Controls Engineering controls and administrative controls will be used to prevent or minimize exposure to biological materials and bloodborne pathogens. Whenever possible, select and utilize engineering controls and administrative controls that mitigate exposure such as, but not limited to: Appropriate Biosafety Cabinets Non-glass capillary tubes Sharps with Engineered Sharps Injury Protections (SESIP’s) Needleless systems Personal protective equipment Administrative controls are defined as: controlling workplace hazards through methods such as training, written operating procedures, work permits, safe work practices, exposure time limitations, alarms, signs, and warnings. The specific engineering controls and administrative controls used as part of this research protocol are listed below: Engineering Controls Administrative Controls Created: November 2011 Reviewed: June 2012 5 Sharps containers shall be replaced before they become overfilled to prevent needle sticks. Sharps must fit completely into the selected sharps container (i.e., not to exceed the manufacturers marked "full" line). Do not bend, break, re-cap, or re-sheath any needle. Do not force or push any item into a sharps container. When the fill line is reached, sharps containers must be closed and locked (all sharps containers come with a locking mechanism). Requests for full sharp container pick-up and replacement containers supplied by Environmental Health and Safety can be made through the Container Request form located at the following URL: http://brown.edu/Administration/EHS/container_disposal/ Personal Protective Equipment (PPE) Describe below, the appropriate PPE that will be used for specific tasks or procedures. (Examples: Nitrile gloves shall be used for handling specimens preserved in formaldehyde, splash goggles will be worn while performing blood draws on mice etc.) Remember, a minimum level of PPE must be worn in the lab at all times i.e., safety glasses and appropriate clothing. PPE Task/Procedure Created: November 2011 Reviewed: June 2012 6 All researchers using PPE must observe the following precautions: Remove gloves carefully to avoid spraying or spatter Wash hands immediately or as soon as feasible after removing gloves or other PPE. Remove PPE after it becomes contaminated and before leaving the work area For proper disposal of PPE please refer to the Brown University Biological Waste Program found at the following URL: http://brown.edu/Administration/EHS/policies/biological_waste_program.pdf Wear appropriate gloves when it is reasonably anticipated that there may be hand contact with blood or OPIM, and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured or contaminated, or if their ability to function as a barrier is compromised Never wash or decontaminate disposable gloves for reuse. Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets of blood or OPIM pose a hazard to the eye, nose, or mouth Remove immediately or as soon as feasible any garment contaminated by blood or OPIM, in such a way as to avoid contact with the outer surface If utility gloves are being used, dispose if contaminated Vaccination/Screening Program Are there any non-routine measures such as special vaccinations or additional health screening techniques that would potentially benefit research staff participating in or supporting this project? ___ No. ___ Yes. If yes, describe___________________________________________________________________________ _______________________________________________________________________________________________. Disinfection and Sterilization Disinfection and sterilization is important for any Biological Research or Biological Waste Disposal. To choose an appropriate disinfectant, the identity of the micro-organisms, their concentration and the degree of inactivation desired should be considered. Physical factors such as whether a space or surface is to be decontaminated, the type of surface, and any interaction between the material and potential disinfectants should also be factored in the selection. Time available for disinfection and the time required for particular disinfectants to be effective need to be considered. For Created: November 2011 Reviewed: June 2012 7 clarification, “disinfection” is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3-12 hours) and are called “chemical sterilants.” Factors that may affect the efficacy of chemical disinfectants include the following: Organic and inorganic load present Type and level of microbial contamination Concentration of and exposure time to the germicide Physical nature of the object (e.g., crevices, hinges etc.) Presence of biofilms Temperature and pH of the disinfection process In some cases, relative humidity of the sterilization process Most disinfectant solutions need to be regularly prepared as fresh solutions to avoid growth of micro-organisms in the solution and to ensure optimum activity of the disinfectant chemical. Remember to don proper PPE including chemically resistant gloves while performing disinfection. If using commercial disinfectants, Federal law requires all applicable label instructions on EPA-registered products to be followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use, and disposal). If the user selects exposure conditions (e.g., exposure time) that differ from those on the EPA-registered products label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 65. Disinfection Tool (Table 1): In order to ensure proper on-site disinfection techniques, the office of Environmental Health and Safety (EHS) has created a disinfection tool which is included in every Exposure Control Plan specific to the agent/space for which it is developed. All University researchers, staff and students involved in biological research or with occupational exposure to bloodborne pathogens must reference this chart before engaging in a protocol, disposing of, storing, or transporting within a building biological materials or bloodborne pathogens. http://www.brown.edu/Administration/EHS/restricted/disinfection_tool.docx Using the Disinfection Tool (Table 1): For all biological materials, wastes, and bloodborne pathogens encountered, the users of an Exposure Control Plan must indicate which disinfectant or sterilant they intend to use along with the recommended dilution, contact time, pH and temperature. A reference in which this disinfectant was recommended must be included in the column labeled “REFERENCE.” If using an EPA-registered or commercial product for disinfection/sterilization please also indicate the name of this product along with its recommended dilution, contact time, pH and temperature (in the disinfection table provided). If utilizing steam sterilization, indicate the settings used i.e., time, temperature and pressure. A good resource for this information is the “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” from the Centers for Disease Control (CDC). To obtain a list of Selected EPA-registered Disinfectants visit: http://www.epa.gov/oppad001/chemregindex.htm Attachments to this table may be included. Created: November 2011 Reviewed: June 2012 8 Spaces within the table that are shaded and marked “NR” refer to disinfectants that were specifically Not Recommended for certain biological materials/wastes by either the CDC, World Health Organization (WHO) and/or the Brown University Institutional Biosafety Committee. For example, the prions category marked with many “NR’s” were shown to have a high innate resistance to many chemical germicides. In fact, proper chemical decontamination for prions as recommended by the WHO include a combination heat and NaOH or for surfaces, by flooding for one hour, with NaOH or sodium hypochlorite, followed by water rinses. If in the course of your research you find conflicting support for disinfectants/sterilants that have been automatically labeled as “NR” in the Disinfection Tool, please contact EHS at 401-863-3353 as it is possible that a product listed as “NR” might be sufficient for the type of disinfection/sterilization you require. Additionally, when using this tool please consider the exceptions and restrictions listed below. Exceptions and Restrictions: Ethanol is not recommended for surface contamination due to the low contact time before evaporation Bleach dilutions made be made fresh daily as the efficacy only last 24 hours Formaldehyde is not a recommended disinfectant due to its carcinogenic properties and its Short Term Exposure Limit (STEL) of 2ppm as set by OSHA. Hydrogen peroxide can cause cosmetic and functional changes in equipment UV radiation has several potential applications, but unfortunately its germicidal effectiveness and use is influenced by organic matter; wavelength; type of suspension; temperature; type of microorganism; and UV intensity, which is affected by distance. UV radiation is not recommended to disinfect surfaces because of lack of penetration The level of biocidal activity of Ortho-phthalaladehyde(OPA) was directly related to the temperature. 0.5% OPA was not sporicidal with 270 minutes of exposure Paracetic Acid and Hydrogen Peroxide can cause cosmetic and functional changes in equipment Table 1 (SEE ATTACHMENT) Housekeeping An organized, clean laboratory is imperative for safety and good research. Maintenance of safety equipment (i.e., emergency eyewashes) is also an important factor in keeping a safe laboratory environment. Routine cleaning and disinfection of all surfaces must be employed. Ensure that only cleanable, non-porous surfaces are used (i.e., fabric chairs shall not be used in the lab). Below, is a list of the routine cleaning/disinfection/maintenance procedures the lab will follow and their frequency: (Example: 10% Bleach dilution, contact time 15 minutes, sprayed on bench tops, nightly) Cleaning/Disinfection/Maintenance Task/Procedure Frequency Created: November 2011 Reviewed: June 2012 9 For a full description of disposal requirements for Biological Waste refer to: http://brown.edu/Administration/EHS/policies/biological_waste_program.pdf Laundry Laboratory coats must be kept in the laboratory when not in use and should never be brought home for laundering. Laboratory coats that have been heavily contaminated with biological agents, infectious substances, or hazardous chemicals shall be replaced. Routine laundering of laboratory coats may be conducted in-house (if available) or by a professional laundering service and approved vendor. Contact the Purchasing Department at 863-2206 for a list of approved vendors. List the types of items specific to this lab or this protocol that may require laundering or replacement when contaminated: Example: (Disposable lab coats, replaced after contamination) Item Replacement/Disposal/Laundering Frequency (if Created: November 2011 Reviewed: June 2012 10 laundering, please specify where and how) In addition, the following general laundering requirements must be met: Handle potentially contaminated laundry as little as possible, with minimal agitation Place wet laundry in leak-proof and appropriately labeled containers before transport Wear appropriate PPE when handling and/or sorting laundry Labels and Door Signs Any equipment or container contaminated with biological materials, bloodborne pathogens or OPIM must display the universal Biohazard symbol i.e., biological sharps containers, vacuum flasks etc. To be NIH compliant, this symbol must also appear on any door where Biosafety Level 1 or 2 (BSL 1 or 2) work occurs or biological waste is held. Also required for a BSL-1 sign: Biosafety Level Name of agent(s) in use Name and phone number of lab supervisor Required for a BSL-2 sign: Biosafety level Laboratory supervisor’s name and telephone number required procedures for entering and exiting the laboratory Created: November 2011 Reviewed: June 2012 11 The standard CEMS emergency contact door sign posted on every laboratory door should reflect this information. If your current sign does not, contact EHS at 401-863-3353. EMERGENCIES In general, Brown University employees and students must not engage in spill response for hazardous substances such as chemical, biological, and radioactive materials. However, in some situations, such as clean up of incidental spills (i.e., a few drops), it is appropriate for the person who caused the incidental spill to clean up the material but only if they have been properly trained and have the appropriate equipment. All other spills must be reported to Brown University Public Safety at 863-4111 so that the Environmental Health & Safety Emergency Response Team may be activated. In the event of a hazardous substance emergency or spill, the following action should be taken: Immediately alert all personnel to evacuate the room. Once everyone is out, close the door behind you. Find a nearby phone and contact Brown University Public Safety at 863-4111. Tend to injured or contaminated personnel. Stay in the general area, at a safe distance away, and wait for emergency responders. Introduce yourself to emergency responders as they arrive. Emergency responders want to ensure that the information they have is accurate and that conditions have not changed since the initial phone call was made. POST-EXPOSURE EVALUATION AND FOLLOW-UP There are several types of exposure that could lead to injury or illness in faculty, staff and students: Parenteral-puncture from a sharp, animal bites Mucous Membrane- contact through eyes, nose, mouth, inhalation Non-intact Skin-cut/scrape, rash, cold sore, acne, hang nail Should an exposure incident occur: • • • • Immediately wash area with soap and water, or in case of an eye exposure flush with copious amounts of water use an emergency eyewash if available Notify your supervisor Contact public safety at 401-863-4111 -if minor/low risk exposure, report to EHS as an alternative to calling public safety Seek first aid/medical treatment and always consult with a physician i.e., health services, your doctor etc. For proper reporting use the forms found here: http://www.brown.edu/Administration/EHS/lab/PDFs/accident_form.pdf http://www.brown.edu/Administration/Office_of_Insurance_and_Risk/documents/Injury%20AR%20Form%20Rev.6%27 06.doc.pdf Created: November 2011 Reviewed: June 2012 12 RESEARCHER TRAINING All researchers who have reasonably anticipated occupational exposure to biological materials, bloodborne pathogens, or OPIM, or potentially dangerous equipment, shall receive task-specific/equipment-specific training conducted by the Laboratory Supervisor or designee. The Laboratory Supervisor shall also ensure that task-specific/equipment-specific training is appropriately documented. Provide below tasks/procedures for which laboratory researchers will receive task-specific/equipment-specific training: (Example: Cardiac puncture blood-draw on mouse, centrifuge training) RECORDKEEPING Training Records Training for task-specific/equipment-specific training shall be documented. These documents will be kept (Insert location of records here____________) for the duration of the Biological Research Authorization and any associated Renewals/Amendments. Created: November 2011 Reviewed: June 2012 13 The following training form template shall be used to document laboratory/equipment specific training: http://www.brown.edu/Administration/EHS/restricted/supervisors_training_template.pdf The training records include: Dates of the training sessions Contents or a summary of the training sessions Names and qualifications of persons conducting the training Names and job titles of all persons attending the training sessions Communication of Hazards Informing Other Employers/Contractors It is the responsibility of the Laboratory Supervisor to provide other employees and contractors with information about hazardous chemicals, biological materials, bloodborne pathogens, and OPIM that employees maybe exposed to on a job site along with suggested precautions and PPE. Before scheduling service with an outside contractor, the equipment to be serviced must be decontaminated unless that piece of equipment is being decontaminated by said outside contractor. In all events contractors or employees should use Universal Precaution while servicing equipment in a Brown University Laboratory. Laboratory Moving/Closeout Policy The purpose of the Brown University Closeout Policy is to ensure that all Research Laboratories and Research Support Areas are properly cleaned and decontaminated prior to decommissioning. Decommissioning of a laboratory or research support area may be necessary when a Laboratory Supervisor leaves the University, transfers to another space, or when a laboratory is prepared for demolition/renovation. There are several resources available to assist Laboratory Supervisors and Departments with tasks related to the proper decommissioning of research space. Some of these resources include, but are not limited to, the following: • Office of Environmental Health & Safety at 863-3353 • Purchasing Department at 863-2206 • Facilities Management at 863-7800 More information on this policy can be located at the following URL: http://www.brown.edu/Administration/EHS/restricted/lab_closeout.pdf Created: November 2011 Reviewed: June 2012