6.1 – Registration of Materials Potentially Infectious for Humans

The Environmental Health and Radiation Safety Department (EHRS) maintains a registry of all Temple University research laboratories and personnel working with human pathogens or human blood, tissues, and body fluids.  In addition, there are specific licensing requirements for individuals who possess, use, handle, store, and transfer SBAs that have the potential to pose a severe threat to both human and animal health, as well as plant and livestock health.. 

EHRS will complete the Human Pathogen Registration Document (HPRD form EHS 6.1F-001) after the IBC registration form is approved.  The Human Pathogen Registration Document must be completed by individuals for any research with any organism known or suspected to cause infections in humans.  All these research protocols require Institutional Biosafety Committee approval prior to initiation of research.

Internet Link to Centers for Disease Control & Prevention Select Agent Program: https://www.selectagents.gov/

6.2 – Biosafety Audit Program

In order to assure that operations dealing with microorganisms are conducted safely and in accordance with federal and Pennsylvania regulations, policies must be available that define criteria for inspections.  The Temple University policy on biosafety inspections is based on biosafety levels (BSL 1, BSL 2, BSL 3 and BSL 4) of facilities and organisms as defined in Biosafety in Microbiological and Biomedical Laboratories (CDC·NIH)

• Biological Materials
• Authorized Biological Agent Users
• Special Biological Agent Users
• Special Biological Agent & Toxin Audit Program

Internet Link to Centers for Disease Control & Prevention Select Agent Program: https://www.selectagents.gov/

6.3 – Good Laboratory Practices

Regulations of the Food and Drug Administration dealing with Good Laboratory Practices are prerequisites for acceptability of the results of certain studies.  These regulations (21 CFR 58) contain detailed descriptions of personnel, facilities, equipment, operation, quality assurance and a number of other areas.  As a matter of policy, Temple University complies with Good Laboratory Practices regulations and the Environmental Health and Safety Department provides services required by the Good Laboratory Practice.

6.4 – Biosafety Universal/Standard Precautions

Federal and Pennsylvania regulations require the development and implementa­tion of precautions to avoid infection of those who may be in contact with potentially contaminated biological materials.  Because a microbiological analysis of every biological sample is impractical, as a matter of policy and consistent with federal and Pennsylvania regulations, it is assumed that blood and certain other body fluids are contaminated with infectious agents.  In addition, tissues; various body fluids; materials derived from cultures containing infectious materials notably HIV or HBV; and equipment that has been in direct contact with infectious materials are considered to be contaminated.

Both federal and Pennsylvania regulations specify universal/standard precautions, engineering controls and personal protective equipment that can be applied for protection of those who may be in contact with potentially contaminated materials.

Specific safety requirement is as identified in BMBL.

6.5 – Exposure Control Plan

Federal and Pennsylvania regulations on bloodborne pathogens describe certain requirements to control the exposure to bloodborne pathogens.

The policy of Temple University for control of hazardous materials, including bloodborne pathogens, relies upon the following principles:

• The concept of keeping exposure to hazardous materials as low as reasonably achievable (ALARA) must be applied to the design and performance of all activities.
• Laboratory principal investigators or supervisors must assure that all activities in their respective areas are conducted safely (Policy No. 1.4).
• The severity of response to a problem will be consistent with its potential impact.
• Each individual is fundamentally responsible for his/her actions.
• Employees must be provided with the appropriate personal protec­tive equipment and training.
• Engineering controls must be in place.

Consistent with these principles, the Temple University Exposure Control Plan consists of the following policies:

Exposure Determination

Policy No. 6.8 provides criteria for exposure determination.  Each administra­tive unit (department, division, etc.) is responsible for identifying those employees that have an exposure potential to bloodborne pathogens.

Annual Review

The Exposure Control Plan will be reviewed and updated annually to reflect changes in technology that eliminates or reduces exposure to bloodborne pathogens. 

Temple University Health System: Consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure is the responsibility of the Temple University Health System Sharp Object Prevention Task Force Committee (TUHS SOIP TFC).  A copy of the minutes from these meetings will be forwarded to EHS by the Infection Control Department of Temple University Hospital on a quarterly basis and attached to the Exposure Control Plan as evidence of compliance with the Bloodborne Pathogens Standard, effective April 18, 2001.

Evaluation and Selection of Effective Engineering and Work Practice Controls

Temple University Health System: The Administration of all Temple University Health System entities will solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice controls.  The documentation of this solicitation and feedback will be a part of the minutes of the TUHS SOIP TFC and forwarded to EHS for attachment to the Exposure Control Plan as referenced above.  A copy of the evaluation tool completed when evaluating new safety devices will be maintained by the Infection Control Department of each TUHS institution and are available for inspection at any time upon request.

Training

All employees with exposure potential to bloodborne pathogens will receive an initial training and an annual retraining.  The core of Temple University training is the initial training provided for Level III employees (Policy No. 3.2).  However, members of the faculty and those with previous training may receive an abbreviat­ed training.

Universal/Standard Precautions

The Temple University Laboratory BioSafety Guide contains essential ele­ments of universal/standard precautions, engineering controls, and personnel protec­tive equipment.  Policy No. 6.4 incorporates relevant sections of that guide by reference.

HBV Vaccination

It is the Temple University policy to offer Hepatitis B virus (HBV) vaccina­tion to all that potentially are exposed to bloodborne pathogens.  Policy No. 6.7 describes the details of the Temple University approach.

HIV Research Laboratories

Certain laboratories engaged in research in HIV must undertake additional actions beyond those required for other facilities.  Policy No. 6.10 describes these requirements.

Sharps Injury Log

A sharps injury log will be maintained by Occupational/Employee Health for recording of percutaneous injuries from contaminated sharps.  The information in the sharps injury log shall be recorded and maintained in such a manner as to protect the confidentiality of the injured healthcare worker.  The sharps injury log shall contain, at a minimum, the following:

• The type and brand of the devices involved in the incident
• The department or work area where the exposure incident occurred
• Explanation of how the incident occurred.

This sharps injury log will be maintained for 5 years after the date of the incident.

Post-Exposure Follow-up

Despite best efforts to avoid exposure to bloodborne pathogens, provisions must be made to treat those who may have been exposed to these pathogens. See Temple Universitry Hospital (TUH ) policy 950.130, 950.130 (A) and 950.130 (B) or department specific policy on Post Exposure follow-up.

Recordkeeping

Temple University adheres to all regulations published in OSHA’s Recordkeeping Rule (29 CFR 1904).  All sharps injuries involving contaminated objects are reported on the OSHA 300 Log of Work-Related Injuries and Illnesses and the OSHA 301 Injury and Illness Incident Report by the Temple University Worker’s Compensation manager or his designee.  This new rule will become effective January 1, 2002.  Until then, a sharps injury log must be maintained at all times as set forth by the new Bloodborne Pathogens Standard.

Infectious or Biological Waste

Temple University's management of infectious or biological waste is described in Policy Nos. 2.3, 2.4, 2.5 and 2.6.

All policies in the Environmental Health and Radiation Safety Handbook, including those related to biosafety, are periodically reviewed and revised, if necessary.

6.6 – Management of Spills of Biological Materials

Temple University has a policy for responding to uncontrolled releases or accidental spills of biological materials.  (Internet Link: Centers for Disease Control Special Biological Agents)

In case of a spill of blood or other biological liquids in laboratories, principal investigators or supervisors are responsible for responding to any release of biological material and must assure that the cleanup occurs as quickly as possible.  They must also assure that no unauthorized person enters the laboratory before the cleanup is completed. 

PI/supervisors must assure the area, equipment, and/or plumbing are disinfected prior to any maintenance or repair. 

6.7 – Hepatitis B Vaccination

In compliance with federal and Pennsylvania regulations, Temple University offers Hepatitis B vaccine to all that are potentially exposed to bloodborne pathogens (See Policy No. 6.5).  The vaccination is available through employee health departments.  Employees whose previously administered antibody testing indicates immunity, or those who may not be vaccinated for medical reasons, are exempted from the HBV vaccination

Employees have the right to refuse the vaccination.  Those who decline the HBV vaccination must fill out Environmental Health and Radiation Safety form 6.7F-001.  Those who decline the HBV vaccination initially may opt to receive the vaccine at any time.

6.7F – Hepatitis B Vaccine Declination

Declination form can be found here.

6.8 – Exposure Determination

In order to assure that individuals who have an exposure potential to bloodborne pathogens receive appropriate training, information and support, it must be determined who is covered by the Temple University policy.  Due to the diversity of activities at Temple University, it is impractical to identify job categories that are exposed to bloodborne pathogens.  Instead, broad categories of jobs are identified realizing that not all employees in those categories have exposure potential to human blood or other potentially infectious material. The following criteria are used to determine the exposure potential to bloodborne pathogens:

• All who in the course of their employment come in contact with patients (health care workers).
• All who in the course of their employment come in contact with developmentally disabled persons.
• All who work or come in contact with blood or other potentially infectious materials.
• Safety and emergency response personnel.

The following individuals are not covered by this policy because they are not considered to be potentially exposed to bloodborne pathogens:

• Medical and nursing faculty and staff who do not come in contact with patients.
• Employees of Facilities Management including personnel involved in plumbing and in heating, ventilation and air conditioning (see Policy No. 6.6).

Individuals, who are employed by Temple University and have an exposure potential in other institutions, must inform the Environmental Health and Radiation Safety Department so that appropriate arrangements are made to assure consistency in compliance with federal and Pennsylvania regulations.

The following contains a listing of selected job categories.  All administrative units will be asked to identify employees in those job categories with an exposure potential based on criteria identified in this policy.

A. Employees having the following job classifications have occupational exposure to blood or other potentially infectious materials:

• Physicians
• Dentists, Dental Laboratory Technicians, Dental Assistants
• Nurses (Registered nurses, licensed practicing nurses)
• Nurses' Aides
• Clinical Laboratory Technologists, Technicians, and Aides
• Clinical Dental Hygienists
• Physical Therapists
• Occupational Therapists
• Sports Trainers
• Housekeeping Staff responsible for patient areas and laboratories at Temple University Health System
• Housekeeping staff responsible for laboratories where infectious materials/blood are handled
• Student Health Staff
• Occupational Health Staff
• Pathologists
• Phlebotomists
• Paramedics
• Researchers
• Blood Bank Technicians
• Security Personnel

B. Certain employees in the following job classification may have exposure to blood or other potentially infectious materials:

• Faculty in the School of Medicine, Podiatry, Dentistry, and Biology
• Staff of Environmental Health and Safety
• Housekeeping staff responsible for areas related to athletes, dormitories, or where research with blood or infectious material is performed.
• Dialysis Personnel
• Facilities Management Personnel
• Biomedical Engineering
• Patient transportation personnel

List of tasks and procedures in which those listed in B. have occupational exposure:

• Contact with blood or other potentially infectious materials
• Performing patient care

6.9 – Inspection and Monitoring of Sterilizer Facilities

Steam sterilization of infectious material utilizes saturated steam within a pressure vessel (known as a steam sterilizer) at temperatures sufficient to kill infectious agents present.  Various government agencies and consensus organizations have recommended periodic inspection of steam sterilizers.  Accordingly, this policy requires an annual inspection of steam sterilizers, as well weekly efficacy validation tests, to ensure effective treatment.

The principal investigators or supervisors of steam sterilizers are required to ensure that steam sterilizers are inspected at least annually.  The inspection should consist of a calibration for temperature and pressure, using an instrument approved by the National Institute of Standards and Technology.  In addition, the steam sterilization process must be monitored on a weekly basis or 40 hours of operation, which ever is sooner, with a biological indicator (Bacillus stearothermophilus).

The principal investigators or supervisors are required to maintain records on the annual inspection and weekly efficacy validation.  These records must be produced upon demand.

6.10 – HIV, SIV, HBV, and HCV Research Laboratories

Consistent with federal and Pennsylvania regulation, it is Temple University policy that research laboratories that use Human Immunodeficiency Virus (HIV), Simian Immunodeficiency Virus (SIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) must take additional precautions to assure a safe operation.

For the purposes of this policy, an HIV, SIV, HBV or HCV laboratory is defined as a facility engaged in the culture, production, concentration, experimentation with or manipulation of either one of these viruses.  However, clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, organs or body fluids are not included in this policy.

Standard microbiological practices and special practices (EHRS Laboratory Biosafety Guide, NIH Guidelines for Research Involving Recombinant DNA Molecules and Biosafety in Microbiological and Biomedical Laboratories) must be used when working with HIV, SIV, HBV, HCV or other potentially infectious materials.  In addition, these laboratories must follow legal requirements promulgated by the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standards-29 CFR 1910.1030(e).  These research activities must be conducted in a Biosafety Level 2 (BSL-2) facility using BSL-3 practices unless only research is involved blood, body fluid or tissue contaminated or potentially infected can be performed with BSL-2 practices. 

Activities involving large-scale volumes or preparation of concentrated HIV, SIV, HBV or HCV must be conducted at BSL-3 facility and practices.  Animal studies involving non-human primates (NHP) and other animals infected with HIV, SIV, HBV or HCV must be performed in Animal BSL-2.

The facilities, practices and responsibilities are indicated below.

• BSL-2 Facilities:
• Laboratory doors should be self-closing and have locks in accordance with Temple policies;
• Laboratories must have a sink for hand washing.  The sink may be manually, hands-free, or automatically operated.  It should be located near the exit door;
• The laboratory should be designed so that it can be easily cleaned and decontaminated;
• Laboratory furniture must be capable of supporting anticipated loads and uses.  Spaces between benches, cabinets, and equipment should be accessible for cleaning;
• Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals;
• Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant;
•  Laboratory windows that open to the exterior are not recommended.  However, if a laboratory does have windows that open to the exterior, they must be fitted with screens;
• A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present.  Posted information must include the laboratory’s biosafety level, the supervisor’s name or other responsible personnel), telephone number, and required procedures for entering and exiting the laboratory;
• Biosafety cabinets (BSCs) must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations.  BSCs should be located away from doors, windows that are opened, heavily traveled laboratory areas, and other possible airflow disruptions;
• Vacuum lines should be protected with High Efficiency Particulate Air (HEPA) filters, or their equivalent.  Filters must be replaced as needed.  Liquid disinfectant traps may be required;
• An eyewash station must be readily available;
• For new facilities consider mechanical ventilation systems that provide an inward flow of air without recirculation to spaces outside of the laboratory;
• HEPA filtered exhaust air from a Class II BSC can be safety re-circulated back into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations.  BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection.  Provisions to assure proper safety cabinet performance and air system operation must be verified; and
• A method for decontaminating all laboratory wastes should be available in the facility (e.g. autoclave, chemical disinfection, incineration, or other validated decontamination method).

• BSL-3 Facilities:
• • Laboratory doors must be self-closing and have locks in accordance with Temple policies;
  • The laboratory must be separated from areas that are open to unrestricted traffic flow within the building;
  • Access to the laboratory is restricted to entry by a series of two self-closing doors;
  • A clothing changing room (anteroom) may be included in the passageway between the two self-closing doors;
  • Laboratories must have a sink for hand washing.  The sink must be hands-free or automatically operated. It should be located near the exit door;
  • If the laboratory is segregated into different laboratories, a sink must also be available for hand washing in each zone;
  • Additional sinks may be required as determined by the risk assessment;
  • The laboratory must be designed so that it can be easily cleaned and decontaminated.  Carpets and rugs are not permitted. Seams, floors, walls, and ceiling surfaces should be sealed.  Spaces around doors and ventilation openings should be capable of being sealed to facilitate space decontamination;
  • Floors must be slip resistant, impervious to liquids, and resistant to chemicals. Consideration should be given to the installation of seamless, sealed, resilient or poured floors, with integral cove bases;
  • Walls should be constructed to produce a sealed smooth finish that can be easily cleaned and decontaminated;
  • Ceilings should be constructed, sealed, and finished in the same general manner as walls;
  • Decontamination of the entire laboratory should be considered when there has been gross contamination of the space, significant changes in laboratory usage, for major renovations, or maintenance shut downs.  Selection of the appropriate materials and methods used to decontaminate the laboratory must be based on the risk assessment of the biological agents in use;
  • Laboratory furniture must be capable of supporting anticipated loads and uses;
  • Spaces between benches, cabinets, and equipment must be accessible for cleaning;
  • Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals;
  • Chairs used in laboratory work must be covered with a nonporous material that can be easily cleaned and decontaminated with appropriate disinfectant;
  • All windows in the laboratory must be sealed;
  • BSCs must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations.  BSCs should be located away from doors, heavily traveled laboratory areas, and other possible airflow disruptions;
  • Vacuum lines must be protected with HEPA filters, or their equivalent.  Filters must be replaced as needed. Liquid disinfectant traps may be required;
  • An eyewash station must be readily available in the laboratory;
  • A ducted air ventilation system is required.  This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas.  The laboratory shall be designed such that under failure conditions the airflow will not be reversed;
  • Laboratory personnel must be able to verify directional air flow.  A visual monitoring device which confirms directional air flow must be provided at the laboratory entry.  Audible alarms should be considered to notify personnel of air flow disruption;
  • Laboratory exhaust air must not re-circulate to any other area of the building.
  • The laboratory building exhaust air should be dispersed away from occupied areas and from building air intake locations or the exhaust air must be HEPA filtered;
  • HEPA filtered exhaust air from a Class II BSC can be safely re-circulated into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations.  BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection.  Provisions to assure proper safety cabinet performance and air system operation must be verified.  BSCs should be certified at least annually to assure correct performance.  Class III BSCs must be directly (hard) connected up through the second exhaust HEPA filter of the cabinet. Supply air must be provided in such a manner that prevents positive pressurization of the cabinet;
  • A method for decontaminating all laboratory wastes should be available in the facility, preferably within the laboratory (e.g., autoclave, chemical disinfection, incineration, or other validated  decontamination method);
  • Equipment that may produce infectious aerosols must be contained in devices that exhaust air through HEPA filtration or other equivalent technology before being discharged into the laboratory. These HEPA filters should be tested and/or replaced at least annually;
  • Facility design consideration should be given to means of decontaminating large pieces of equipment before removal from the laboratory. Final HEPA filtration of the laboratory exhaust air; laboratory effluent decontamination; and advanced access control devices such as biometrics;
  • HEPA filter housings should have gas-tight isolation. The HEPA filter housing should allow for leak testing of each filter and assembly. The filters and the housing should be certified at least annually; and
  • The BSL-3 facility design, operational parameters, and procedures must be verified and documented prior to operation. Facilities must be re-verified and documented at least annually.

• Institutional Biosafety Committee (IBC):
• • Review and approve all protocols submitted by Principal Investigators involving the use of HIV, SIV, HBV, or HCV;
  • Evaluate and approve BL-3 facilities prior to conducting any experiments;
  • Review and approve policies and procedures describing the collection and storage of serum samples from at-risk personnel;
  • Review and investigate all violations involving non-compliance with this policy and recommend corrective actions; and
  • Review, investigate and maintain records of all incidents involving release, loss, exposure to HIV, SIV, HBV, or HCV and recommend corrective actions.

D. Environmental Health and Radiation Safety (EHRS):

• Policy implementation;
• Periodically audit laboratories and report the results of these audits to IBC;
• Perform additional audits as requested by IBC to evaluate compliance with Temple policy, as well as federal and state regulations;
• Provide training as requested by IBC or Principal Investigator;
• Respond, evaluate and make recommendations regarding  to incidents of exposure of individuals to HIV, SIV, HBV, or HCV to IBC and, if applicable, to regulatory agencies;
• Respond, evaluate and make recommendations regarding to incidents involving release of HIV, SIV, HBV, or HCV to IBC and if applicable to regulatory agencies;
• Evaluate policies and procedures for safe use, disposal and handling; and
• Post the appropriate hazards warning signs.

E.   Principal Investigators, Supervisors, and Managers:

• Submit the protocol prior to use to IBC for review and approval;
• Establish written policies and procedures that allow only persons who have been advised of the potential biohazard(s), who meet any specific entry requirements, and who comply with all entry and exit procedures will be allowed to enter the work area and animal rooms;
• Ensure that laboratory workers and animal care providers receive initial and annual training appropriate with their duties, as well as illustrating necessary precautions to prevent exposure, and exposure evaluation procedures;
• Ensure that laboratory workers are trained and competent in Standard Operating Procedures (SOP) and Temple policy prior to working with infectious substances and that they are trained in any SOP and/or policy changes;
• Inform lab workers of the potential health impact of materials, as well as immunization availability and/or prophylactic administration;
• Provide information regarding immune competence and conditions that may predispose them to infection, particularly in regards to women of child-bearing age.
• Encourage lab workers to raise their health concerns with Temple University Employee Health Physicians;
• Assess their site and operations to determine safety of facility and operation;
• Ensure that a copy of this policy is distributed to all staff involved in HIV, SIV, HBC, or HCV research and that a copy is kept in the investigator’s laboratory at all times for reference or that the staff is trained to access the electronic copy of this policy through the EHRS website at www.temple.edu/ehrs;
• Limit laboratory access to only authorized persons;
• Provide appropriate Personal Protective Equipment (PPE) without charge to Lab workers;
• Ensure that all Class II Biosafety Cabinets (BSCs) are working properly and are certified at least annually by a qualified vendor and operated according to manufacturer’s recommendations;
• Ensure that all procedures involving the manipulation of infectious materials are conducted within a BSC or other appropriate physical containment devices and not on open benches;
• Maintain an inventory of HIV, SIV, HBV, or HCV-infected stock solutions, cell lines, and animal subjects;
• Ensure that all containers containing HIV, SIV, HBV, or HCV-infected materials are properly stored, labeled, transported, and disposed;
• Contact EHRS for guidance in the transportation of HIV, SIV, HBV, or HCV-infected materials;
• Ensure that anyone exposed to HIV, SIV, HBV, or HCV should be directed to Occupational Health during work hours or Temple University Emergency Department (TUED) after work hours for immediate medical evaluation and treatment and that exposure is reported to IBC and EHRS;
• Ensure vacuum lines are protected with liquid disinfectant traps and HEPA filters or filters of equal or superior efficiency and these devices are routinely checked and maintained;
• Adopt an improved engineering and work practice controls that reduce risk of sharps injuries;
• Implement an effective integrated pest management program;
• Ensure that all pieces of equipment are decontaminated before removal or transfer from the laboratory for disposal, repair, or maintenance; and
• Ensure that animals and plants that are not associated with the work being performed are not permitted in the laboratory

F. Laboratory Workers:

• Must be aware of the potential hazards in the use of HIV, SIV, HBV, and HCV in their research studies;
• Must perform their work in accordance with written SOP;
• Must comply with specific entry and exit requirements to HIV/SIV/HBV/HCV facility;
• Must demonstrate proficiency in standard and special microbiological practices as well as the laboratory SOP prior to working with infectious agents;
• Must complete all required EHRS training;
• Must be informed of all pertinent regulations and policies regarding the safe use of infectious agents;
• Must wear protective laboratory clothing with a solid-front (such as tie-back or wraparound gowns), scrub suits, or coveralls when working inside the laboratory;
• Must keep the laboratory doors closed while working with infectious agents;
• Must remove all protective clothing and dispose in the laboratory before leaving the laboratory;
• Must decontaminate reusable clothing before laundered;
• Must change clothing when contaminated;
• Must wear all appropriate personal protection equipment (PPE) such as eye, face shield, mask, gloves, etc.; and
• Must immediately seek medical attention from Occupational Health during work hours or TUED after work hours when exposed to infectious agents.

G. Definitions:

• Class II Biosafety Cabinet (BSC): The Class II (Types A1, A2, B1 and B2) BSCs provide personnel, environmental and product protection. Airflow is drawn into the front grille of the cabinet, providing personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination across the work surface of the cabinet. Because cabinet exhaust air is passed through a certified HEPA filter, it is particulate-free (environmental protection), and may be recirculated to the laboratory (Type A1 and A2 BSCs) or discharged from the building via a canopy connection. Exhaust air from Types B1 and B2 BSCs must be discharged to the outdoors via a hard connection.  All Class II cabinets are designed for work involving microorganisms assigned to biosafety levels 1, 2 and 3.
• Class III BSC: The Class III BSC (Figure 8) was designed for work with highly infectious microbiological agents and for the conduct of hazardous operations and provides maximum protection for the environment and the worker. It is a gas-tight (no leak greater than1x10-7 cc/sec of SF6 at 3 inches pressure Water Gauge) enclosure with a non-opening view window. Access for passage of materials into the cabinet is through a dunk tank, that is accessible through the cabinet floor, or double-door pass-through box (e.g., an autoclave) that can be decontaminated between uses. Reversing that process allows materials to be removed from the Class III BSC safely. Both supply and exhaust air are HEPA filtered on a Class III cabinet. Exhaust air must pass through two HEPA filters, or a HEPA filter and an air incinerator, before discharge to the outdoors. Airflow is maintained by a dedicated, independent exhaust system exterior to the cabinet, which keeps the cabinet under negative pressure (minimum of 0.5 inches of pressure Water Gauge).

6.11 – Shipment and Importation/Exportation of Biological and Infectious Materials

The U.S. Department of Transportation (DOT), the US Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC), the U.S. Postal Service (USPS) and the International Air Transport Association (IATA) all have requirements that influence the shipping of dangerous goods from Temple University and Temple University Health System.  Infectious substances are one of several types of dangerous goods that may be offered for shipment.

Any person wishing to submit a dangerous good for shipment must first receive training to do so from Environmental Health and Radiation Safety.  The purpose of this policy is not to substitute for training, but to provide an overview of the regulations that pertain to the shipment of biological and infectious substances, as well as to the governmental agencies regulating the permitting processes.

Infectious Substances are substances known to contain, or reasonably expected to contain pathogens.  Pathogens are microorganisms (including bacteria, viruses, rickettsia, parasites, and fungi) or recombinant microorganisms (hybrid or mutant) that are known or reasonably expected to cause infectious disease in humans or animals.

Infectious substances include;

• • all cultures containing or suspected of containing an agent that may cause infection.
  • human or animal samples that contain such an agent in quantities sufficient to cause infection, should an exposure to them occur due to a transport mishap
  • sample(s) from a patient with a serious disease of unknown cause
  • other specimens not included above and designated as infectious by a qualified person, e.g., a physician, scientist, nurse, etc.

Diagnostic Specimens are any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected animals. Diagnostic specimens resulting from medical practice and research are not considered a threat to public health.

However, if during transport exposure to a specimen could result in an infection, the specimen must be packaged, labeled and transported as an infectious substance.

Diagnostic specimens meeting the definition of the World Health Organization (WHO) Risk Group 4 (biological agents with high risk to the individual and to the community) must be classed and transported as Infectious Substances.

Biological Products are those products derived from living organisms that are manufactured and distributed in accordance with the requirements of national governmental authorities that may have special licensing requirements.  They are used for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto.  They include, but are not limited to, finished or unfinished products such as       vaccines and diagnostic products.

Training: All persons wishing to submit packages containing dangerous goods, including infectious substances, must become certified to ship dangerous goods by attending training.  Certification must be renewed every two years.  Contact EHRS to arrange for training.

Training will include;

• Classification and Identification of the material
• Packaging Requirements
• Marking and Labeling the Package
• Preparing the Shipping Papers

Record Keeping: All records must be retained for three (3) years from the date of shipment.

6.12 – Select Biological Agents

To comply with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Act of 2002, Temple University prepared this guide for the possession, use, handling, storage, and transfer of select biological agents and toxins (SBA) that have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal plant products.  The current list of these agents is available directly from the Centers for Disease Control and Prevention web site: https://www.selectagents.gov/

The laboratory practice, technique, safety equipment and facility design should be in accordance with the current U.S. Department of Health & Human Services Centers for Disease Control and Prevention and National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories guidance (BMBL). 

6.13 – Importation/Exportation of Infectious Agents

Importation of infectious materials, etiologic agents and vectors that may contain them is governed by federal regulation.  An import permit is required for any infectious agent known to cause disease in humans, animals and plants.  This includes but is not limited to bacteria, viruses, rickettsia, parasites, yeasts and molds.  In some instances, an agent that is suspected of causing human disease also requires a permit.

Any person wishing to offer an infectious agent for shipment (export or import) must first receive training to do so from Environmental Health and Radiation Safety. 

All records must be retained for three (3) years from the date of importation or exportation.

6.14 – Using Biological Toxins (Including Exempt Quantity Biological Select Agents and Toxins)

Purpose
Biological Toxins are toxic substances that can be produced by bacteria, fungi, protozoa, insects, animals, or plants and are classified separately from chemical toxins. They are non-replicative, noninfectious materials but can be extremely hazardous, causing death or severe incapacitation at relatively low exposure levels.

Biological Select Agents and Toxins (BSAT) are materials that have been identified by the United States Government as agents with potential for use in biological terrorism or warfare. The Federal Select Agent Program (FSAP) regulates the possession, use, and transfer of select agents and toxins (see Temple Policy 6.14 – “Using Biological Select Agents and Toxins”) that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant programs. The FSAP is managed jointly by:

• The Division of Select Agents and Toxins (DSAT) at the Centers for Disease Control and Prevention (CDC) which is part of the U.S. Department of Health and Human Services (HHS).
• The Agriculture Select Agent Services (AgSAS) at the Animal and Plant Health Inspection Service (APHIS), which is part of the U.S. Department of Agriculture (USDA). 

Certain toxins included in the FSAP are exempt from CDC and/or APHIS requirements if possessed in small quantities, so called Exempt Quantity Select Biological Toxins. A list of the exempt toxins and threshold quantity limits can be found in Table 2, on page 4 of this policy.

This document outlines the Temple University requirements for receipt, possession, use, and transfer of Biological Toxins and Exempt Quantity Select Biological Toxins.

Biological Safety Program Roles and Responsibilities for Work with Biological Toxins

• The Vice President for Research
  • Is the Responsible Official (RO) for the Temple University.
  • Delegates some of the responsibilities through the Director of Environmental Health and Radiation Safety Department (EHRS) to the Biological Safety Officer (BSO).  
  • Has also charged the Institutional Biosafety Committee (IBC) to oversee the Biological Select Agents and Toxins biosafety program.
• The Principal Investigator (PI)
  • Must register the use of Biological Toxins and Exempt Quantity Biological Select Agents and Toxins (including work with animals) with the Institutional Biosafety Committee (IBC) by submission of the Biosafety Registration Form (BRF) to IBC Office. Work involving recombinant or synthetic DNA encoding the active subunit(s) of biological toxins in cells, organisms, or viruses must also be registered and approved by the IBC.
  • Must store all Biological Toxins and Exempt Quantity Biological Select Agents and Toxins in secondary containment.
  • Is responsible for preparing a written Standard Operating Procedure (SOP) for the safe handling of each Biological Toxins and Exempt Quantity Biological Select Agents and Toxins being used in the laboratory including the following:
  • • Lethal Dose 50% (LD50), along with the route of administration and the model used,
    • Symptoms of acute intoxication,
    • Availability of vaccine or antitoxin,
    • Inventory and record keeping,
    • Personal Protective Equipment (PPE) for research personnel,             
    • Engineering controls (biological safety cabinets, animal caging systems, centrifuge safety containers),
    • Precautions when working with animals,
    • Safe handling, storage, and use of toxins in the laboratory,
    • Decontamination/inactivation and disposal procedures,
    • Spill cleanup procedures
    • Before submission of SOP to IBC for review please contact EHRS with any questions or concerns.
  • Is responsible for providing initial lab-specific Biological Toxins and Exempt Quantity Select Biological Toxins safety training to lab workers.  Training must include all elements included in the SOP.
  • Is responsible for providing proper PPE when using Biological Agents and Toxins (gloves, safety goggles, face shield, lab coat or disposable lab coat).
  • Is responsible for providing proper engineering controls for using Biological Agents and Toxins (fume hood, biosafety cabinet, or glove box with toxin-associated procedures).
  • Must complete EHRS’s online training course “Biological Agent and Toxin Safety Training”.

PIs are subject to federal regulations for “Due Diligence” when transferring any amount of Biological Toxin to another investigator or individual. PI has to submit the "Request to Transfer Exempt Amounts of a Biological Select Agent and Toxin" form to Biosafety Officer, who will verify as part of the registration process, that the recipient PI has a legitimate need to possess the material. In addition, recipient PI has to be approved by IBC to use the particular Biological Select Agent and Toxin in his laboratory.

• Laboratory Employees who work with Biological Toxins and Exempt Quantity Select Biological Agents and Toxins
  • Must complete EHRS’s online training course “Biological Agent and Toxin Safety Training”.
  • Must follow SOP to handle biological toxins safely, secure them properly when they are not in use, update inventories regularly and dispose of materials appropriately when work is completed.
  • Must promptly report to PI, BSO, RO and IBC any unsafe or unhealthful conditions.
  • Should be familiar with the signs and symptoms of toxin exposure and should be vaccinated if a vaccine is available for the biological toxin.
• Environmental Health & Radiation Safety (EHRS)
  • Is responsible for the policy implementation
  • Will provide online course “Biological Agent and Toxin Safety Training” to PIs and lab workers.
  • Will provide technical assistance and support, as needed.

Terms specific to this Policy

• Select Biological Agents – Select Agents are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". These bio-agents are divided into three broad categories: (1) HHS select agents and toxins (affecting humans); (2) USDA select agents and toxins (affecting agriculture); and (3) Overlap select agents and toxins (affecting both).
• Biological Toxins - a biological toxin is a poisonous substance produced within living cells or organisms. Toxins can be small molecules, peptides, or proteins that are capable of causing disease.
• Responsible Official (RO) is the individual designated by the entity to act on its behalf. This individual must have the authority and control to ensure compliance with the regulations. For purposes of this policy, the RO is the Vice President for Research, the alternate RO is the Institutional Biosafety Officer (BSO).

Training

• Biological Agent and Toxin Safety Training, provided by EHRS either online or in person, is required for PI and authorized persons who are registered by IBC to work with Biological Toxins and Exempt Quantity Biological Select Agents and Toxins.

Recordkeeping

• Principal investigators must maintain a current and accurate Biological toxins inventory.

References

Table 1. Biological Toxins

*based on the information provided by Dr. X. Qin, formerly of the Department of Neuroscience, LKSOM, Temple University, Philadelphia, PA

Table 2. Exempt Quantity Biological Toxins

*for the most recent changes in the Federal Select Agent Program please go to:https://www.selectagents.gov/sat/permissible.htm?CDC_AA_refVal=https%3A%2F%2Fwww.selectagents.gov%2FPermissibleToxinAmounts.html