9 - BIOSAFETY

 

Section Contents

9.1	INTRODUCTION
9.2	BLOODBORNE PATHOGEN EXPOSURE CONTROL
9.3	GENERAL BIOHAZARDOUS MATERIALS PROCEDURES
9.4	PERSONAL PROTECTIVE EQUIPMENT USE IN BIOHAZARDOUS MATERIAL AREAS
9.5	BIOLOGICAL SAFETY CABINETS
9.6	OTHER EQUIPMENT USED IN THE BIOHAZARDOUS MATERIALS LABORATORY
9.7	DISINFECTION AND STERILIZATION PROCEDURES
9.8	BIOHAZARDOUS WASTE DISPOSAL
9.9	EXPERIMENTAL ANIMALS
9.10	SHIPPING PATHOGENIC MATERIALS
9.11	BIOSAFETY CONTAINMENT AND BIOSAFETY LEVELS
9.12	RECOMBINANT DNA RESEARCH
9.13	PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT

 

9.1

INTRODUCTION

This section provides information and guidance on safe laboratory practices involving biological hazards.  It contains University policies and procedures which have been adopted to promote laboratory safety and ensure compliance with regulatory requirements.  This section also contains the University's Bloodborne Pathogen Exposure Control Plan.

Principal Investigators and supervisors must supplement this information with instruction and guidance on specific practices and procedures unique to the work being done in their laboratories.

9.2

BLOODBORNE PATHOGEN EXPOSURE CONTROL

The Catholic University of America's Bloodborne Pathogen Exposure Control Plan has been developed in accordance with OSHA's Bloodborne Pathogen Standard (BPS), 29 CFR 1910.1030 and OSHA's Access to Employee Exposure and Medical Records 29 CFR 1910.1020. The BPS applies to all University employees who have occupational exposure through skin, eye, mucosal, or parenteral contact with blood or other potentially infectious materials (OPIM).  The documented occupational routes of transmission of bloodborne pathogens are by (1) needlestick or cut from a contaminated sharp object; (2) splash to the eyes, nose, or mouth; and (3) contact with broken skin.

All employees included in the University bloodborne pathogen (BBP) program are required to receive initial and annual refresher BBP training. University employees who currently work in laboratory settings and are potentially impacted by the BBP program include, but are not limited to, Nursing, Biology, and Biomedical Engineering. Non-laboratory employees who are potentially covered by the BBP program include, but are not limited to, Custodial Services, Public Safety, and Athletics.

The plan complements University's Institutional Biosafety Committee (IBC) registration programs for human pathogens, blood and body fluids, and recombinant DNA. The Environmental Health and Safety Department (EHS) is responsible for maintaining, approving, and incorporating revisions to this plan. All proposed revisions to this plan must be submitted to EHS for review.

Availability: EHS will ensure that the Bloodborne Pathogen Exposure Control Plan is made readily available to all University employees at any time via the web or through EHS at (202) 319-4461.  The Exposure Control Plan will also be made available to OSHA's Assistant Secretary and Director upon request for examination and copying.  The OSHA BPS can be found on the OSHA website.

Annual Review: EHS reviews the Bloodborne Pathogen Exposure Control Plan on an annual basis. The review includes the analysis of new or modified job tasks, procedures, employee positions involving occupational exposure, and any new technology that has been deemed to eliminate or reduce BBP exposure. Student Health Services (SHS) shall be notified as relevant revisions occur to the University BBP Exposure Control Plan. 

Contract Services: Companies that contract services to the University which might involve potential employee exposure to bloodborne pathogens must have their own exposure control plan.

9.2.1

Definitions

Biohazard: An infectious agent or hazardous biological material that presents a risk or potential risk to the health of humans, animals or the environment. The risk can be direct through infection or indirect through damage to the environment.

Biohazardous Materials: Includes certain types of recombinant DNA; organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia); and biologically active agents (i.e. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community.

Blood: Human blood, blood components, and products made from human blood.

Bloodborne Pathogens: Pathogenic microorganisms that may be present in human blood that can cause disease in humans, such as Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV).

Contaminated: The presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

Contaminated Sharps: Objects that can penetrate the skin (needles, scalpels, broken glass, broken capillary tubes, etc.) and have or may have blood or other potentially infectious material on their surfaces.

Decontamination: The use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface to the point where they are no longer capable of transmitting infection and the surface is rendered safe for handling, use, or disposal.

EHS: Department of Environmental Health and Safety.

Engineering Controls: Controls that isolate or remove the bloodborne pathogens hazard from the workplace. (e.g. safer medical devices, such as sharps with engineered sharps injury protections and needleless systems, sharps disposal containers, self-sheathing needles).

Exposure Incident: A specific mucous membrane, broken skin, or puncture contact with blood or OPIM that results from the performance of an employee's duties.

Occupational Exposure: Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.

Other Potentially Infectious Materials (OPIM): (1) the following body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with blood; (2) any unfixed tissue or organ (other than intact skin) from a human (living or dead); (3) HIV-containing cell or tissue cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs or other tissues from experimental animals infected with HIV or HBV.

Parenteral: Introduced into the body by piercing mucous membrane or skin through events such as a needlestick, human bite, cut, or abrasion.

Personal Protective Equipment (PPE): Specialized clothing or devices worn by an employee for protection against a hazard (ex. gloves, splash goggles, apron, respirator).

Physician or Other Licensed Health Care Professional (PLHCP): An individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows him or her to independently provide, or be delegated the responsibility to provide, some or all of the health care services required.

Primary Containment: Protection of personnel and the immediate laboratory environment through good microbial technique (laboratory practice) and the use of appropriate safety equipment (primary barriers).

Regulated Biological Waste: Waste that consists of: liquid or semi-liquid blood; other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; pathological and microbiological wastes containing blood or other potentially infectious materials.

Secondary Containment: Protection of the environment external to the laboratory from exposure to infectious materials through a combination of facility design and operational practices.

Sharps: Objects that can pierce the skin such as needles, scalpels, syringes, razor blades, etc.

Standard Precautions: Infection control philosophy that expands the coverage of Universal Precautions by recognizing that any body fluid may contain infectious microorganisms.

Sterilize: The use of a physical or chemical procedure to destroy all microbial life.

Universal Precautions: An approach to infection control whereby all human blood and other potentially infectious materials are treated as if known to be infected with HIV, HBV, and other bloodborne pathogens.

Work Practice Controls: Methods that reduce the likelihood of exposure by altering the manner in which a task is performed.

9.2.2

Exposure Determination

The University shall perform an exposure determination through evaluation of job descriptions and interviews with employees, to identify employee classifications that may entail occupational exposure to blood or OPIM.  This exposure determination shall be made without consideration of the use of personal protective equipment (PPE). The exposure determination is to be updated annually or as required based on information received from all affected departments.

Below are the current job classifications in which some employees may have occupational exposure through routine and non-routine job tasks.

Job Classification	Tasks/Procedures
Athletic Coach	Providing first aid/CPR
Athletic Trainer	Providing first aid/CPR
Biomedical Engineering Faculty & Research Staff	Conducting research involving blood and OPIM
Biology Faculty & Research Staff	Teaching clinical laboratory science courses; conducting research involving blood and OPIM
Facilities Maintenance: Custodial Services	Handling and disposing of blood and OPIM
Nursing Faculty	Teaching undergraduate clinical sequence, graduate nurse practitioner sequence
Pool Lifeguard	Providing first aid/CPR
Public Safety	Providing first aid/CPR, emergency situations handling and disposing of blood and OPIM

If a supervisor or department manager has an employee with a reasonably anticipated risk of BBP or OPIM exposure, they should contact EHS at (202) 319-4461 for further assistance.

Note: The OSHA Bloodborne Pathogen standard only covers employees, including paid students. EHS recommends that each department head include volunteers and unpaid students into the program. If students, volunteers, etc. have reasonably anticipated contact with blood or OPIM, then they should be included into the program; OR the Department should choose to have these individuals perform other work that does not involve potential exposure.

 

9.2.3

HIV and HBV Research Laboratories and Production Facilities

The BPS has specific requirements for HIV and HBV research laboratories and production facilities (i.e., labs that are engaged in the culture, production, concentration, experimentation, and manipulation of HIV or HBV; it does not include clinical or diagnostic labs engaged solely in the analysis of blood, tissue, or organs). There are no such labs currently or proposed at the University. Nevertheless, since it is prudent for the protection of the health & safety of University employees, sections of this plan were written such that the plan can address the requirements of HIV and HBV research laboratories and production facilities. Additional training is required for laboratory employees who work with HBV or HIV. The Exposure Control Plan will be modified to meet these requirements if the research status changes. Work may not begin until the IBC reviews and approves all proposed experiments involving HIV or HBV research.

9.2.4

Universal Precautions/Risk Assessment

Universal precautions must be observed by University employees in order to prevent occupational exposure or contact with blood or OPIM.  Such materials are to be considered infectious regardless of the perceived status of the source individual. All employees involved in teaching or research activities that require the handling of blood or OPIM shall take precautions to prevent contact with these materials.

In the athletics environment, universal precautions should be utilized during the immediate control of bleeding and when handling bloody dressings, mouth guards, bandages, etc. It is required that appropriate gloves be used for the examination, cleaning and dressing of wounds. It is also noted that athletes may not compete or train at any level of competition if wounds have not been treated and covered.

9.2.5

Risk Assessment

The factors of interest in a risk assessment include:

• The pathogenicity of the infectious or suspected infectious agent, including disease incidence and severity.
• The route of transmission of newly isolated agents may not be definitively established.
• Agent stability is a consideration that involves not only aerosol infectivity but also the agent's ability to survive over time in the environment.
• The infectious dose of the agent.
• The concentration or number of infectious organisms per unit volume should be considered.
• The origin of the potentially infectious material is also critical in doing a risk assessment.
• The availability of data from animal studies.
• The established availability of an effective prophylaxis or therapeutic intervention should an infection take place.
• Medical surveillance that includes employee monitoring.
• An evaluation of the experience and skill level of those individuals who will be handling and will be in direct contact with the agents.

EHS is available to assist in this process and should be contacted for questions concerning radiation, chemical and biological safety and waste disposal.  Once a risk assessment is completed, the results should be communicated to everyone involved in the process.

9.2.6

Engineering and Work Practice Controls

Use engineering and work practice controls to eliminate or minimize exposures. Engineering controls will be examined, maintained or replaced on a regular schedule to ensure that they are working optimally.  Where occupational exposures remain after institution of these controls, personnel must additionally wear PPE.  The following engineering controls should be used when appropriate and where feasible:

• Approved sharps containers
• Biological safety cabinets (located in Hannan Hall, Nursing Biology, McCort-Ward Hall)
• Handwashing facilities/antiseptic hand cleaner and towels
• ANSI approved eyewash stations
• Emergency showers
• Automatic pipettes
• Autoclaves

Biological safety cabinets serve as primary barriers and are required for all work with blood or OPIM.  The units must be certified when installed, when moved, and at least annually thereafter. Preventative maintenance and examination should be implemented to these control items on a regular basis. Laboratory renovations and construction plans are reviewed by EHS to ensure appropriate design, placement of biological safety cabinets, containment, and foot traffic patterns.

The selection of primary and secondary barriers is based upon the pathogenicity of the agent, planned laboratory manipulations, and the potential for aerosolization. Corroboration is provided by representatives of the Academic Safety Committee and/or the Institutional Biosafety Committee. Whenever possible and practicable, use new safety technology, such as shielded needles, self-sheathing needles, retracting needles or needleless systems.

The following work practice controls should be implemented throughout the campus:

• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses in work areas where occupational exposures may occur.
• Do not store food or drink in refrigerators, freezers, etc., where blood and OPIM are present.
• Do not pipette by mouth.
• Place all specimens of blood or OPIM in an appropriately labeled container that will not leak during collection, handling, processing, storage, transport and shipping.
• If the primary container is punctured or should leak, place the primary container within a secondary container that is puncture resistant.
• Wash hands immediately after removing gloves and other types of PPE.
• Take precautions to prevent injuries caused by needles, scalpels, and other sharp instruments or devices during procedures; when cleaning used instruments; during disposal of used needles; and when handling sharp instruments after procedures.
• Report any injuries as soon as practical to management or supervisory personnel.
• To prevent needlestick injuries, do not re-cap needles, purposely bend or break them by hand, remove them from disposable syringes, or otherwise manipulate them by hand.
• Perform all procedures involving blood or OPIM in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances.
• Examine equipment which may become contaminated with blood or OPIM, prior to servicing or shipping and decontaminate as necessary.
• Cover specimens placed in a centrifuge with a sealed cap to prevent spillage and aerosol droplet formation.
• Use plastic tubes and pipettes (instead of glass), along with knives with retractable blades.
• Employees with pre-existing skin lacerations or medical conditions that exhibit open wounds or sores should consult with management and EHS before working in an area with potential BBP issues.

Employee Supervisors and Department Managers must develop additional proper work practice controls relevant to their specific laboratory.

9.2.7

Labels and Signs

Labels

Biohazard labels must have a red or fluorescent orange colored background with the traditional biohazard symbol in a contrasting color. Affix labels as close as possible to the container by either string, wire, adhesive, or similar method that prevents the loss or removal of the label. Mark secondary containers (used for leaking primary containers) with the biohazard label when biohazards are present.

Signs

Post biohazard signs, consisting of a red or fluorescent orange colored background with the traditional biohazard symbol in a contrasting color, at each entrance to all laboratories deemed to contain Biosafety Levels 2 or above. Include the following information on the sign: the containment level, the principal investigator, the supervisor, their phone numbers, and the required PPE.

9.2.8

Personal Protective Equipment

The type of personal protective clothing or equipment used in a specific instance will depend on the job being performed.  Each department is responsible for purchasing the proper PPE for their area.  It should not cost the employee at all to obtain, clean, launder, replace, repair or dispose of his or her PPE.

Appropriate PPE (such as lab coats, face shields/masks, eye protection, CPR mouthpieces, pocket masks, etc.) must be provided to potentially exposed CUA employees and must be readily accessible at the work area.  Supervisors, department managers, or designated personnel must ensure that employees have access to PPE in the correct size and that it is in good working order when provided to the employee.

All PPE must be visually inspected by the wearer prior to use to verify that it is in good condition. Hypoallergenic gloves, powderless gloves, or other alternatives shall be readily accessible to any employee deemed to be allergic to the gloves normally provided. All authorized visitors must wear the protective clothing prescribed for the area(s) in which they work or visit.

PPE will only be considered appropriate if it does not permit blood or OPIM to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time in which the PPE will be used.

Face Protection

Safety glasses or safety goggles with solid side shields in combination with masks, or chin length face shields or other splatter guards are required for anticipated splashes, sprays, or splatters of blood or OPIM to the face or eyes.  The eyes, nose and mouth should always be protected.

Laboratory Clothing

This group includes laboratory coats, smocks, scrubs and gowns. The use of long sleeved apparel is recommended to reduce potential exposure of skin or street clothes.  The garment should be resistant to liquid penetration and must be capable of being either disposed of or withstanding sterilization, in the event that it becomes contaminated.  Wear lab coats in all laboratories when working at BSL-2 levels or above.  Remove protective clothing and other personal protective equipment before exiting the immediate laboratory where the work is being performed.  Provide disposables to visitors, maintenance workers or other persons in the event that it may be required.  Do not take any laboratory clothing or equipment home for washing purposes.

Gloves

Select gloves based on the hazards involved in the research that is being conducted.  Wear latex or nitrile gloves:

• when blood or OPIM are handled in tubes, flasks, bottles, pipettes or plates.  
• when agents are centrifuged, fractionated, lyophilized, etc.  
• for operations that involve delicate operations.  

Polyvinyl chloride gloves (PVC) are not recommended for work with blood or OPIM, as they do not always provide a leak-proof barrier.  Rubber, neoprene, or other thick reusable gloves are more durable and are generally used for more strenuous activities, such as cleaning up blood spills. Wear temperature resistant gloves when handling or autoclaving hot material or dry ice.  Replace gloves if torn, punctured, or any time that the barrier is broken. Never reuse or rewash disposable gloves.  Personnel who have dermatitis or other lesions on the hands and who may have indirect contact with blood or OPIM must also wear protective gloves.  For assistance in glove selection, contact EHS at (202) 319-4461.

Respirators

For certain protocols and research projects, respirators may be required to increase worker protection. This selection process is based on the hazard and the amount of protection required for the workers. EHS must be contacted prior to the start of any projects that require respirator use to assist in the selection of the appropriate equipment, medical surveillance, fit testing, and the associated required training.

Resuscitation Masks

Although saliva has not been implicated in HIV transmission, to minimize the need for emergency mouth-to-mouth resuscitation, mouthpieces, resuscitation bags, or other ventilation devices should be readily available for use in areas in which the need for resuscitation is predictable. Personnel who perform cardiopulmonary resuscitation (CPR) should have resuscitation masks on hand for use in case of an emergency. Most resuscitation masks are disposable and should be handled as contaminated waste following use. The resuscitation mask allows for effective CPR without mouth-to-mouth contact. Most masks can also be fitted with a one-way valve, which prevents the flow of materials from the victim to the rescuer.

9.2.9

Housekeeping Techniques

Use the following housekeeping techniques:

• Clean and decontaminate all equipment and work areas as soon as possible after contact with blood or OPIM.
• Isolate the area to be cleaned and disinfected by placing a tape barrier or other barrier around the site and by posting warning signs. Remove the barrier and signs when the area is completely dry.
• First clean/remove gross contamination to ensure the disinfectant is completely effective.
• Wash the floor and other contaminated surfaces with soap and water followed by an EPA-registered disinfectant.
• For laboratory settings, the Principal Investigator (PI) shall determine and implement an appropriate written schedule for cleaning and decontamination, taking into consideration the location within the facility, the type of surface to be cleaned, and any tasks and procedures being executed within the area.
• The level of PPE should be appropriate for the anticipated exposure.
• Use disinfectants made for cleaning bathroom surfaces for this purpose only. They should also be used according to the manufacturer's directions. Consult Safety Data Sheets (SDSs) to determine the types of necessary PPE.
• BSL-2 laboratories at the University are maintained and cleaned by Custodial Services personnel on a "request only" basis.
• Remember that most disinfectants are corrosive and can cause irritation if they come into contact with a person's skin.

Please refer the list of EPA registered disinfectants.  Diluted bleach (1:10 part solution) must be made up daily. Do not use bleach that is older than 24 hours for disinfection or decontamination purposes.

9.2.10

Contaminated Laundry

Bed linens, clothing, or towels are not treated as medical/biological waste, unless there is visible contamination with blood or OPIM.  Handle laundry as little as possible and place it in a bag or container. The laundering is at no cost to employees, and each department is responsible for establishing laundering procedures for contaminated clothing.  Anyone having contact with the contaminated material should wear appropriate PPE and observe Universal Precautions.

9.2.11

Sharps Use

Syringes and needles are extremely dangerous objects that need to be handled with caution to avoid any accidental injections, injuries and or aerosol generation. Restrict the use of syringes and needles to procedures for which there is no alternative.  Never substitute a syringe or needle in place of a pipette.  Use needle locking syringes or disposable units in which the needle is an integral part of the syringe.  Do not purchase "needle-cutter" devices, which may produce aerosols when used.  Follow these recommendations when working with sharps:

• Work in a biosafety cabinet whenever possible.
• Wear gloves at all times.
• Minimize air bubbles.
• Expel air, liquid and bubbles into a cotton pad moistened with disinfectant.
• If the outside of the primary container becomes contaminated, place the primary container within a secondary container (same container characteristics as listed above) that will prevent further leakage during handling, storage, or transport. Label the secondary container with the biohazard label.
• Have sharps containers easily accessible to personnel for use and located within immediate working area.
• Maintain the sharps container upright throughout use.
• Replace the sharps container routinely and do not allow it to become more than 3/4 full or to the indicated line on the container. Adding syringes and needles into a sharps container that is nearly filled may cause accidental exposure.
• Never bend, shear, or remove needles from a syringe or cap them after use. If a needle must be capped after use, use a mechanical device or the one-handed method.

Always dispose of needles and syringes into an approved sharps container.  Approved sharps containers are available in various sizes and must be:

• Able to be securely closed
• Puncture resistant
• Leak proof on both sides and bottom
• Labeled or color-coded (contaminated container should be labeled with biohazard sign)

Departments are responsible for the purchase of approved sharps containers. Do not use food containers such as coffee cans to dispose of contaminated sharp objects.  Reusable sharps containers must meet the same requirements as containers for disposable sharps, with the exception that they are not required to be closable.  Never reach into a sharps container, as this increases the likelihood of an accidental needle stick or cut.

To dispose a full sharps container, immediately close it prior to removal, place it in a secondary container (if leaks occur), and label or color-code it. Contact EHS at (202) 299-2698 for the waste to be collected and disposed of properly.

Residence Hall Sharps Container Disposal: Residence hall residents that use needles for medical reasons will have access to biohazard approved sharps containers from SHS at no cost to the resident. Once the approved sharps container is full (or when the student relocates), the resident should return the closed box to SHS for proper disposal.

9.2.12

Regulated Waste Disposal

Mixed Waste: Sharps that are contaminated with radioactive materials or hazardous chemicals should be discarded into separate sharps containers labeled with the name of the isotope or chemical.  When discarding waste containing an infectious agent and radioactive material, inactivate the infectious agent first, and then dispose of the waste as radioactive waste.  The same inactivation method applies when the mixed waste contains infectious agents and chemical waste.  The infectious waste should be inactivated first. Please contact (202) 299-2698 for further disposal information.

Animal Tissues, Carcasses and Bedding: Place animal carcasses/tissues into a plastic bag. Double-bag the carcass when it contains infectious agents. Place the bag in a labeled refrigerator unit until pick-up can occur. Please contact EHS (202) 299-2698 to arrange disposal.

Broken Glass: Broken glass is not considered medical/biological waste unless it is visibly contaminated with blood or OPIM but still needs to be handled with extreme care.  Use mechanical means such as pliers, tongs, forceps, or a broom, brush and dustpan to pick up broken glass or metal scraps and place them into an appropriate sharps container.  Never pick broken glass up with your hands, even if you are wearing gloves.

Regulated Waste: For the disposal of solid waste such as rags, bandages, gauze, gloves, etc., place items in designated waste cartons and/or red plastic bags labeled "infectious waste" or "biohazardous waste". It is the supervisor's responsibility to designate appropriate central storage locations for the regulated waste containers. If the outside of an infectious waste bag becomes contaminated or torn, the first bag must be placed inside a second infectious waste bag before transport. EHS should be contacted at (202) 299-2698 for disposal.  In limited cases where Custodial Services personnel accumulate regulated waste as a result of accident remediation activities, the waste bags may also be delivered to SHS for disposal if advance notice is provided to SHS personnel at extension 5744.

Note that the cost of disposing waste is by weight. To avoid excessive disposal fees, please be sure that waste placed within the red/orange biological bag waste stream does in fact contain biological/medical waste.

Biohazard disposal bags are used for the transport and disposal of contaminated items that are not sharp in nature. Bags should be changed when approximately half full and securely sealed to prevent leakage. To avoid airborne release, do not try to squeeze the air from the biohazard disposal bags to reduce its size prior to disposal.

Autoclave use: There are currently two freestanding autoclaves located in McCort-Ward Hall. They are to be used to decontaminate solid biohazardous waste. The biohazard autoclave bags can be purchased from various laboratory product distributors, such as Fisher Scientific, VWR, and Baxter.  Select polypropylene bags that are able to withstand autoclaving. The bags should be placed inside of a rigid container with a lid, while the waste is being collected before being autoclaved.  The University currently has a contract with Consolidated Stills & Sterilizers (CSS) to perform preventative maintenance on the autoclave units. The company can be reached at 1-877-250-7500 or 617-899-1392.  It is the responsibility of each principal investigator (PI) to train their staff on the use of the autoclaves and what is/is not permitted to be placed in them.  There are several smaller benchtop autoclaves within certain laboratories in both McCort-Ward and Nursing-Biology. It is the responsibility of the laboratory personnel to ensure that proper preventative maintenance is occurring on the autoclaves, including an annual maintenance check. All personnel that use the autoclaves should monitor the equipment to assure that proper sterilization occurs. Proper instrumentation should be used to verify that the time, temperature, and steam are adequate.  Use Steristrips, autoclave tape, or some other form of verification routinely to ensure that the autoclave is working properly.

Waste Boxes: Infectious waste boxes are cardboard boxes with red plastic liners and biohazard labels that are used for the disposal of research materials that have been contaminated with hazardous biological agents.  The following are some examples of materials that would be placed in these waste boxes: tissue samples, slides, broken lab glassware, pipettes, and absorbent pads.  Do not pour liquids into the waste boxes.  Collect needles and syringes in the red puncture resistant approved sharps containers. Please contact EHS at (202) 299-2698 for further information.

9.2.13

Biohazard Spill Cleanup Procedures

Since spills of biological materials (unplanned release of potentially infectious material into the work environment) can occur, it is important to be prepared prior to dealing with the problem.  Proper response to these particular incidents can ensure personnel and community safety while eliminating environmental contamination.  Ensure that the response is conducted effectively and safely by: (1) implementing a spill response procedure for the working environment, (2) assuring that spill cleanup materials are available for use, and (3) assuring that all personnel are trained in the provisions of the spill response procedure. Laboratories working with biohazards should have a basic biological spill kit ready for use at all times. For most instances, the basic kit can be assembled with materials already used in the working area. Although it is preferable to have the contents of the spill kit in one location, as long as the materials are easily accessible to everyone in a laboratory, prior assembly might not be necessary. Replenish items within the Biological Spill Kit as they are used, so they will be available for the next use.  Include the following items in the spill kit:

• Disinfectant (Hydroxy-Pro, Clorox bleach, etc.)
• Absorbent material and towels
• Waste container and biohazard bags
• Personal protective equipment (gloves, respirator, splash goggles etc.)
• Mechanical tools (forceps, broom and dustpan, tongs etc.)

Pre-packaged spill kits designed for cleaning up small (less than 10 milliliters) potentially infectious spills are available through most laboratory supply catalogs.

In some situations, it may not be appropriate for personnel to clean up a biohazardous spill. This may be the case if:

• An employee has not received training in biohazardous spill cleanup.
• Appropriate spill materials are not available.
• The spill is a combined hazard spill (radiation and biohazard, chemical and biohazard).
• The spill is too large to be handled by University personnel (generally greater than 1 liter).

In this type of situation, personnel must:

• Notify others in the work area of the spill.
• Close off and isolate the area where the spill has occurred.
• Contact Public Safety at (202) 319-5111, and they will in turn notify EHS personnel.
• Keep others out of the spill area until responders arrive and the spill hazard is cleaned up.

Any department that has a potential for a spill of blood or OPIM should have a written spill response procedure and materials readily available.  Each situation should be evaluated on a case-by-case basis. Factors to be considered in determining in-house spill response versus outside assistance would include: the amount of surface area contaminated, type of surface, volume of material, and the source.

9.2.14

Hepatitis B Vaccine

Employees identified in the Exposure Determination to have reasonably anticipated occupational exposure to blood or OPIM are to be offered the Hepatitis B vaccine series. The Hepatitis B vaccine series is available at no cost to the employee through SHS. The Hepatitis B vaccine should be made available after the employee has received the initial BBP training and within 10 working days of initial assignment with the potential infectious materials.

The Hepatitis B vaccine program consists of a series of three intradeltoid inoculations over a six-month period. The first does is administered at the time of enrollment into the program. The second dose is usually administered one month after the initial dose, with the third dose occurring 6 months after the initial. The titer may be completed approximately 2 weeks to 1 month after the completion of the three inoculations and vaccination series. It is the responsibility of the employees to make their own appointment with SHS to receive the vaccine. After participants in the BBP program have received their initial training, all employees who wish to receive the vaccine should contact SHS within one month from the training date.

Employees have the prerogative to decline the Hepatitis B vaccine. Those who decline must sign a waiver that uses the exact wording in Appendix A of the OSHA standard. Employees who initially decline the vaccine but later wish to receive it, are still able to obtain the vaccine provided that they are still performing the same job task that has the associated risk exposure.

It is the responsibility of EHS to assure that (1) the appropriate employees are informed that they are eligible to receive HBV immunization, and (2) either the vaccine series is received or waivers are signed. Copies of applicable documents are maintained by EHS.

9.2.15

Post-Exposure Evaluation and Follow-Up

Any employee incurring an exposure incident must be offered post-exposure evaluation and follow-up in accordance with the OSHA standard.  If you encounter an exposure incident, report it immediately to your supervisor. The supervisor must ensure that the employee is offered the opportunity for an immediate medical evaluation.

Contact Public Safety (202) 319-5111 to arrange transportation to Providence Hospital Emergency Room for initial evaluation and treatment.

Nursing Students/Faculty: Should the exposure incident involve a nursing student on a clinical rotation or nursing faculty at a clinical facility, they should report the incident immediately to their on-site clinical instructor or appropriate nursing staff and report to the emergency department of the clinical site immediately for lab work, counseling and evaluation for possible need for post-exposure prophylaxis. The affected student or faculty member must also report to SHS within one week of the incident.

For incidents occurring on-campus, EHS, those persons involved in the incident and their supervisors will document the route of exposure and the circumstances related to the incident. This follow-up is to include the following elements:

• Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred.
• If applicable, the identification of the source individual will be determined, and consent will be obtained to draw a sample of blood to test for HIV, HBV and HCV infectivity. Permission to disclose any results (postivie or negative) to the person exposed will also be sought at the same time.  If consent and permission to disclose is obtained, the blood sample is drawn.
• Results of serologic testing of the source individual will be made available to the exposed employee and the exposed employee is to be informed about the applicable laws and regulations concerning disclosure of the identity and infectivity of the source individual.
• Exposed employees will be offered the option of having blood collected by a medical facility or the nearest open clinic for testing of HIV/HBV serological status. The blood sample will be preserved for up to 90 days to allow the employee to decide if the blood should be tested for HIV serological status. However, if the employee decides prior to that time that testing will or will not be conducted, and then the selected action will be taken and the blood sample appropriately discarded.
• The employee will be given appropriate counseling by the referred infectious disease physician concerning precautions to take during the period after the exposure incident. The employee will also be given information on potential illnesses for which to be alert and to report any related experiences to appropriate personnel.

Employees, students or volunteer workers who have rendered assistance in any situation involving the presence of blood or OPIM (regardless of whether an actual exposure incident, as defined by OSHA, occurred) must do the following:

• Report all first aid incidents involving the presence of blood or OPIM to their supervisor as soon as possible.
• Include the names of all first aid providers who rendered assistance in the report and fully describe the incident including time and date.

The Supervisor must provide the report as soon as possible to EHS to determine whether or not an exposure incident actually occurred.  In cases where EHS determines that exposure did occur, the affected individual is to immediately comply with the Post-Exposure Evaluation and Follow-Up requirements of this Plan.

Any unvaccinated employee, student or volunteer worker who rendered assistance is then eligible to receive within 24 hours, and at no cost, the hepatitis B vaccination series.

EHS will maintain a record of all such first aid incidents and, upon request, make this available to employees with reason to know and OSHA.

9.2.16

Training

Training for employees must be conducted prior to initial assignment to tasks where reasonably anticipated occupational exposure may occur. Retraining must occur on an annual basis thereafter. The training will not incur a cost for the employee and will be conducted during normal business hours. The content must explain each of the following elements:

• The OSHA standard for bloodborne pathogens.
• Epidemiology and symptomatology of bloodborne diseases.
• Modes of transmission of bloodborne pathogens.
• This Exposure Control Plan, i.e., points of the plan, lines of responsibility, how the plan is to be implemented, etc.; an employee may also obtain a copy of the written plan.
• Procedures that might cause exposure to blood or OPIM at the University.
• Methods to control exposure to blood or OPIM.
• Available PPE and who should be contacted concerning selection and use.
• Signs and labels.
• Hepatitis B vaccine program.
• Information on emergency procedures following exposure incidents, including incident reporting and post-exposure medical evaluation and follow-up, and an opportunity to ask questions regarding protection from bloodborne pathogens.

Additional training is required when changes occur, such as modification of tasks or procedures and new tasks or procedures that affect the employee's occupational exposure.

9.2.17

Recordkeeping

All records required by the OSHA BBP standard are kept and maintained by either SHS or by EHS.

Medical records shall be maintained for each employee with occupational exposure in accordance with 29 CFR 1910.1020, Access to Employee Medical Records and Information, and must include the following:

• The employee’s name and University issued employee number
   
• A copy of the employee’s Hepatitis B vaccination status, including dates of all vaccinations and any medical records relative to the employee’s ability to receive vaccination.
   
• Copies of medical examinations, tests, and follow-up procedures.
   
• The healthcare professional’s written opinion.
   
• A copy of the information provided to the healthcare professional. 

A written report or opinion will be obtained from the health care professional who evaluates or treats employees in the two following instances:

• Prophylactic Vaccination: A written report from SHS or other appropriate health care provider will be obtained when an employee is sent to obtain the Hepatitis B vaccine. In this case, the written report will indicate that the employee has completed the vaccination series. SHS will provide EHS with a final written statement once the vaccination has been completed.
• Post-exposure Evaluation and Follow-up: A written opinion will be provided by the PHLCP whenever an employee is sent to a health care professional following an exposure incident. The written opinion will be limited to whether the employee was informed of the results of the evaluation and any medical conditions resulting from exposure to blood or OPIM which require further evaluation and treatment. All other medical findings or diagnoses not relevant to the exposure incident will remain confidential and will not be included in the written report. A written opinion shall be provided to the employee within 15 days of the completion of the evaluation. The written report should include:

o        Whether the Hepatitis B vaccination was indicated for the employee.

o        If the employee has received the vaccination.

o        The results of the employee evaluation.

o        That the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment.

All other findings or diagnoses will remain confidential and will not be included in the written report.

Medical records must be kept confidential and must not be disclosed or reported, without the employee's explicit written consent, to any person within or outside the workplace except as may be required by law. SHS must maintain medical records relative to bloodborne pathogen exposure incidents for at least the duration of employment plus 30 years.

Sharps Injury Log: A sharps injury log is established and maintained by EHS. The sharps injury log is a record of all reported percutaneous injuries from contaminated sharps. The information within the sharps injury log is recorded and maintained in a way to protect the confidentiality of the injured employee. Per 29 CFR 1904.6, Recording and Reporting Occupational Injuries and Illness, this log will be maintained for 5 years following the end of the year at which the incident occurred. The following elements are required to be documented:

• Type and brand of device involved in the accident. 
   
• Department where the accident occurred.

Training Records must be maintained for 3 years from the date on which the training occurred. EHS must provide these training records upon request for examination and copying to employees, to employee representatives, and to OSHA.  The training documentation should include, but is not limited to the following:

• Contents of the training session.
   
• Names and qualifications of persons conducting the training.
   
• Names and job titles of persons attending training

9.2.18

References

• 29 CFR 1910.1030, Bloodborne Pathogens Standard 
   
• 29 CFR 1910.1020, Access to Employee Exposure and Medical Records 
   
• 29 CFR 1904.6, Recording and Reporting Occupational Injuries and Illness

 

9.3

GENERAL PROCEDURES FOR BIOLOGICAL AGENTS

9.3.1

Biohazard Sign and Biohazard Labeling

• Display the Universal Biohazard Symbol on a sign at the entrance to all areas where these materials are used, on applicable storage cabinets, and as a label on individual containers. 
   
• Affix Universal Biohazard Labels to containers by adhesive, wire, or other method that prevents unintentional removal of a label.
   
• Red bags or red containers may be substituted for labels on waste containers.

9.3.2

Start of New Programs

• For all major and/or unique programs using infectious or potentially infectious materials, recombinant DNA, animals, select agents/biological toxins, and/or human products such as blood, cells, etc.: hold a preliminary planning session with a representative of the Institutional Biosafety Committee (IBC) to discuss the possible impact of the anticipated program on the Health & Safety of the employees who may be involved, and to evaluate if the laboratory facility is adequate to safely conduct the research.  
  Any recommended improvements will be dictated by applicable regulations and guidelines, along with standard industry protocols and best practices.
   
• Submit appropriate Research Registration Forms to the IBC prior to the start of research activities involving: recombinant DNA; agents that are infectious to humans, animals and plants; other potentially infectious materials; select agents and biological toxins; or human materials including blood, cells, unfixed human tissues and other body fluids.
   
• Upon review of the Research Registration Forms, the IBC will determine if the project requires full committee approval prior to the start of work in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules.
   
• The Principal Investigator is responsible for ensuring that necessary precautions are clearly understood by the technical personnel before the start of the program and/or research activity and that the required safety practices and procedures are observed throughout the course of the program and/or research activity.

9.3.3

Biohazardous Materials Laboratory Access

• Display the Universal Biohazard Symbol at the entrance to all laboratories in which biohazard research is in progress. List on the warning sign: the name of the infectious agent; special requirements for entry (gloves, face protection, respirators, etc.); and, the name and telephone numbers of the principal investigator or other appropriate supervisor.
   
• Unauthorized individuals must not enter laboratories where potentially hazardous biological, chemical, or radioactive materials are being used.
   
• Neither visitors nor family members are allowed to move about unaccompanied in a biohazardous materials laboratory.

9.3.4

Food, Drink, and Cosmetics in the Biohazardous Materials Areas

• Do not eat, drink, smoke, apply cosmetics or lip balm, shave, or handle contact lenses in any University laboratory or in any other area where there is a reasonable potential for pathogen or body fluid exposure.
   
• Do not store food or drink, even temporarily, in refrigerators, freezers, shelves, cabinets, or upon counter tops or benches where biohazardous materials or body fluids are present.

9.3.5

Spill/Accident Reporting

• Immediately report all spills or accidents that result in eye, mouth, mucosal, non-intact skin or peritoneal contact with potentially infectious materials, including human blood and body fluids to your supervisor and EHS.
   
• Housekeeping staff, since they are not trained on biohazards, must not clean-up a biohazard spill. If a spill is too large to handle, presents a threat to personnel or the public, or you are unsure how to proceed with clean-up, call Public Safety at (202) 319-5111. There is a dispatcher on duty 24-hours at this extension who will inform the appropriate emergency response personnel.
   
• All injuries, whether they involve biohazardous materials or not, must be reported to one's supervisor as soon as possible.

9.3.6

Sanitation/Housekeeping

• Ensure that your laboratory work site is maintained in a clean and sanitary (decontaminated) condition. 
   
• The laboratory supervisor must develop and implement an appropriate written schedule for cleaning and a method of decontamination. Sanitation in laboratories is the responsibility of laboratory staff and not that of the housekeeping staff. 
   
• Collect all biohazardous waste only in orange/red bags specially labeled for such use or in metal covered containers specially designed for autoclaving. The biohazard waste bags must incorporate sterilization indicators and meet the standards for both ASTM D 1922-67 for tear resistance (>480 g) and ASTM D 1709-85 for impact resistance (>165 g). If metal reusable containers are used, they must be labeled as containing biohazardous waste and have an autoclave-sensitive sterilization indicator.
   
• Sterilize all biohazardous waste by autoclaving prior to disposal. Autoclave waste contained in metal autoclavable containers on the same day that the waste is collected. Store biohazardous waste contained in biohazard bags in the room of generation until the autoclave is available for sterilization, and then immediately sterilize it. Do not allow non-sterilized biohazardous waste to accumulate in the autoclave room.
   
• Biohazardous waste can be legally disposed of only after sterilization. The investigator or a trained student/technician is to place waste from sterilized reusable containers directly into opaque bags and dispose of the waste through Custodial Services. Similarly, waste in sterilized biohazard bags or disposable biohazards sharps containers must be placed into opaque bags for disposal through Custodial Services. 
   
• Place only biohazardous waste into biohazard or any orange/red bags. All wastes in these bags will be assumed to be biohazardous and must be sterilized before disposal.

9.4

PERSONAL PROTECTIVE EQUIPMENT USE IN BIOHAZARDOUS MATERIAL AREAS 

Refer to section 18 for requirements of the University's personal protective equipment (PPE) program. Appropriate PPE (such as, lab coats, face shields/masks, eye protection, CPR mouthpieces, resuscitation bags, pocket masks, etc.) must be provided to potentially exposed employees at no cost and must be readily accessible at the work area. Supervisors must ensure that employees use PPE  whenever warranted.

9.4.1

Protective Clothing and Gloves

• All employees and authorized visitors must wear the protective clothing prescribed for the area(s) in which they work or visit.
   
• Wear disposable plastic or rubber gloves whenever biohazardous materials are handled (be it in tubes, pipettes, flasks, bottles, or plates), centrifuged, fractionated, lyophilized, etc. Glove use is mandatory whenever hand contact is possible with potentially infectious human tissues including all blood, mucus membranes, and non-intact skin.
   
• Completely change clothing and wear gloves, head covers, shoe covers, and filter masks whenever working in rooms that house animals inoculated with or exposed to biohazardous materials classified as BSL3. (See the following appendices in the NIH Guidelines for a discussion of physical containment for biological agents, Biosafety Level 1 (BSL1) through Biosafety Level 4 (BSL4):
  
  
  • Appendix G: physical containment for standard laboratory experiments, and
  • Appendix K: physical containment guidelines for large scale (greater than 10 liters of culture) research or production involving viable organisms containing recombinant DNA molecules.
• Wear surgical caps/hoods and shoe covers in addition to other required protective equipment when working in areas where gross contamination can reasonably be anticipated (e.g., autopsies, orthopedic surgery). 
   
• Do not wear laboratory clothing and other personal protective equipment outside the immediate work areas.
   
• If any garment is contaminated by infectious materials including blood, immediately remove the garment and store it in a red bag. 
   
• Autoclave contaminated clothing prior to laundering it. Handle contaminated laundry as little as possible, and place it in a labeled container or red-bag it for transportation. Wear protective gloves and other PPE as necessary when handling contaminated laundry. 
   
• Replace disposable gloves when the gloves become contaminated, torn, or otherwise compromised. Discard them into a red bag.

9.4.2

Eye and Face Protection

• Wear safety goggles or face shields in those areas and/or during activities that constitute an eye or face hazard. Contact lenses provide no protection, and wearers must follow all requirements for eye protection (safety glasses, goggles, face shields, etc., as appropriate). 
   
• Wear masks in combination with eye protection devices whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may pose eye, nose, or mouth contamination hazards.

9.4.3

Eye Wash Station

• Equip each area using biohazardous materials with a readily available eye wash station. 
   
• Following contact of eyes or other mucus membranes with potentially infectious materials, flush affected areas with water immediately or as soon as feasible.

9.4.4

Handwashing

• Equip each area using biohazardous materials with a readily accessible handwashing facility. Wash hands immediately after removal of gloves or other personal protective equipment. 
   
• Following contact of hands or other skin surfaces with potentially infectious materials, wash affected body areas with soap and water immediately or as soon as feasible.

9.4.5

Respirators

• Certain experiments may require the use of respiratory protection to prevent exposure to biohazardous dust or other hazardous aerosols. Contact EHS prior to using respirators and for questions relating to the selection of respiratory protective equipment.

 

9.5

BIOLOGICAL SAFETY CABINETS

9.5.1

General Criteria for the Use of Biological Safety Cabinets (BSCs)

• Perform work involving biohazardous agents in laminar flow BSCs. Do not conduct work with potentially infectious materials on an open bench.
   
• Confine the inoculation and necropsy of infected experimental animals to a primary barrier such as a Class I or Class II ventilated cabinet.
   
• Confine all work with Class 4 agents to an absolute primary barrier system, i.e., Class III cabinets.
   
• Annually test and certify all BSCs for adequate air flow and/or containment using a qualified testing laboratory. (EHS will secure the services of a qualified contractor to annually certify the cabinets.) 
   
• Do not use volatile toxic compounds, flammable solvents, or radioisotopes in laminar flow safety cabinets, unless the appropriate exhaust and/or filter systems are installed.
   
• Take adequate precautions, with consideration for both equipment and operating practices, to reduce the potential hazards of aerosol generating processes such as centrifugation, sonication, grinding, fractionation, etc. Operate smaller laboratory equipment, that may generate aerosols, in the appropriate BSC, as determined by risk.

9.5.2

Effectively Using BSCs

Use BSCs effectively by following these procedures:

• Keep the laboratory meticulously clean. Minimize the storage of unnecessary materials such as boxes and supplies, particularly near the BSC.
   
• Wash hands thoroughly before and after working in the BSC. Wearing a clean lab coat and gloves while working in a BSC increases personal safety and helps reduce contamination of research materials.
   
• The effectiveness of a BSC is a function of directional airflow, inward and downward, through a high efficiency particulate air (HEPA) filter. Anything that disrupts the airflow pattern reduces cabinet effectiveness. Examples include: rapidly moving one's arms in and out of the BSC, allowing people to walk rapidly behind you, drafts from ventilation systems, and drafts from open laboratory doors.
   
• Understand how the cabinet works. Plan your work. Protect yourself, your research, and your co-workers.

9.5.3

Recommended Protocol for the Operation of BSCs

• Put on a clean lab coat. Thoroughly wash your hands. Put on gloves, if appropriate.
   
• Turn on the BSC. Wipe the work surface with 70% ethanol. Allow the cabinet to run at least five minutes before beginning work. 
   
• Wipe off each item needed for the procedure and place it in the cabinet. 
   
• Do not place objects over the front air intake grille; do not block the rear exhaust grille. Perform work at least six inches back from the front air intake grille.
   
• Segregate contaminated and clean items. Minimize movement of contaminated items over clean ones. Remember . . . "work from clean to dirty." 
   
• Follow good microbiological techniques, such as holding open tubes and bottles as horizontal as possible. 
   
• Always use pipetting aids. Never use a mouth pipette. 
   
• When working in a BSC, use horizontal pipette discard pans containing appropriate disinfectant. Do not use vertical pipette discard canisters on the floor outside cabinet.
   
• It is inadvisable to flame items. The flame creates thermal turbulence in airflow which may compromise sterility and safety; excessive heat buildup may damage the filters.
   
• If you need to remove or introduce items within the BSC, move your arms slowly in and out of the BSC to minimize disruption of the airflow.
   
• If you use equipment that creates air turbulence in the BSC (such as a centrifuge, blender, sonicator, etc.), place the equipment in the back 1/3 of the cabinet. Stop other work while equipment is operating.
   
• Protect all vacuum systems from biohazard contamination by placing a liquid disinfectant trap and a HEPA cartridge filter between the vacuum trap and the vacuum source in the cabinet.
   
• Clean all spills in the cabinet immediately. Wait 3-5 minutes before resuming work if procedures allow. 
   
• Remove all materials and wipe all interior surfaces with 70% alcohol when you are finished working. Let the cabinet fan run 10 minutes before turning it off. Examine the tray under the work surface, disinfecting and cleaning as necessary.
   
• Discard waste materials appropriately (autoclave, etc.).
   
• Remove lab coat and wash hands thoroughly before leaving biohazardous materials area.

 

9.6

OTHER EQUIPMENT USED IN THE BIOHAZARDOUS MATERIALS LABORATORY

9.6.1

Pipettes

• Do not pipette by mouth.
   
• Do not blow air out of pipettes, as this can generate a hazardous aerosol. 
   
• Completely immerse contaminated reusable pipettes in an appropriate disinfectant bath. When BL3 agents are used, employ a horizontal bath containing disinfectant in a hood. Autoclave the covered container of pipettes as a unit before cleaning. (If sodium hypochlorite has been used as the disinfectant, use sodium thiosulfate to neutralize the chlorine before autoclaving.) 
   
• When plastic or discardable glass pipettes are used, place them in a horizontal autoclave bag that is sealed prior to removal. In the case of disposable Pasteur pipettes or broken pipettes, carefully place material in a sharps container to decrease the risk of cuts or punctures. 
   
• Dispose of pipettes 1 ml and smaller as sharps.

9.6.2

Syringes and Needles

• Do not bend, recap, or remove contaminated needles, syringes, and other sharps. Such activities are notorious for causing needle-stick injuries and are specifically forbidden by OSHA regulation. 
   
• Never shear or break a contaminated needle. This could easily generate dangerous aerosols and is a specific violation of OSHA regulation. 
   
• After use, immediately place contaminated needles and other sharps in sharps containers for disposal or processing as necessary. A safe sharps container is puncture resistant, leak-proof, labeled with the biohazard symbol, and readily accessible. Replace the sharps container regularly; do not overfill the container. 
   
• If leakage of the primary sharps container is suspected or likely to occur when moving the container from the area of use, place the primary container in a closable, leak-proof, labeled, secondary container.
   
• For reusable glass syringes, use only the Luer-Lock type. 
   
• Decontaminate all syringes and needles by total submersion in a disinfectant before autoclaving. Do not remove needles or otherwise manipulate them before autoclaving. Alternatively, use special sharps containers designed for syringe disposal. Never overfill such containers. 
   
• Do not withdraw needles from a vial or ampule without first surrounding the point of removal with a cotton pledget moistened with a suitable disinfectant.
   
• Do not expel the contents of a syringe into an open room. Expel into a cotton pledget moistened with disinfectant.

9.6.3

Centrifuges

• Operate a centrifuge only if you know how to properly do so. Consult your supervisor for guidance. 
   
• Before centrifuging, inspect glass tubes for chips or cracks. Since cracked or chipped glass compromises the strength of a tube, it is more liable to shatter under centrifugal force. To eliminate shattering, use plastic centrifuge tubes when appropriate. 
   
• Use centrifuge trunnion cups with screw caps or an equivalent safety seal. Inspect the trunnion cups for obvious wear and for the presence of adhering material that may result in cap leaks. Carefully remove any bits of glass from under the rubber cushion. Periodically pressure-check trunnion cups for leaks.
   
• Use only tightly sealed tubes. Fill tubes (be careful not to overfill) and cap them in a laminar flow cabinet or other biohazard cabinet as required. After tubes are filled and sealed, wipe the surface with a disinfectant.
   
• In the case of highly infectious or toxic materials, a germicidal solution or inactivating liquid may be added between the trunnion cup and centrifuge tube to inactivate the material if the tube should break. After centrifugation of hazardous material, open the cups in the safety cabinet.
   
• Avoid pouring (decanting) from centrifuge tubes, since this usually leads to surface contamination and aerosol generation. Use a pipette to transfer contents. 
   
• Immerse contaminated cups and tubes in a disinfectant immediately after use.

9.6.4

Vacuum Systems

• Protect all vacuum systems from biohazard and chemical contamination. In the case of vacuum systems involving microbiological samples, install a liquid trap of concentrated disinfectant and an absolute biological filter (HEPA) in the vacuum system between the collecting flask or the point of application and vacuum source. If a collecting flask is used, autoclave and replace it daily or when full. 
   
• For non-microbial samples, install a chilled vapor trap before the vacuum source to prevent contamination of the vacuum source and the environment. 
   
• To avoid vessel implosion, flasks used as collecting reservoirs or as traps are to be made of plastic or heavy-duty glass specifically made for use in vacuum systems. Use only side-arm flasks designed for use under vacuum. 
   
• For lyophilizers, decontaminate both the condenser and vacuum trap after each use. Allow for controlled re-equilibration in vacuum manifolds or lyophilizers.

9.6.5

Roller and Shaker Equipment 

• Place shaker flasks or bottles containing biohazardous agents in unbreakable pans deep enough to hold the contents of the flasks should breakage occur. To reduce aerosol spread from broken flasks, cover the pans with a top having an absolute filter. 
   
• Hold flasks or bottles securely in place to prevent breakage.
   
• Manipulate cultures in such a manner as to prevent wetting of the plugs or caps.

9.6.6

Blenders, Homogenizers, Grinders, Sonicators, and Lyophilizers

• Blenders, homogenizers, grinders, sonicators, and lyophilizers create considerable amounts of aerosols when processing materials. Therefore, always operate and open this equipment in a safety cabinet when working with biohazardous agents. To reduce the amount of aerosol generated, wait 30 seconds or more after the equipment has been turned off before opening and removing the processed material. 
   
• The preparation, handling, and use of lyophilized microorganisms presents a potentially severe hazard, since the accidental release of such powders can result in aerosols of very high concentration. Cross contamination can readily occur, therefore, handle the powders in a ventilated cabinet. Heavy contamination also can occur at the air exhaust port or manifold outlets of a lyophilizer. Always wear appropriate protective equipment when removing materials from the lyophilizer.

9.6.7

Water Baths

• All apparatus containing water baths used to inactivate, incubate, or test infectious substances must contain a disinfectant. For cold water baths, 70% propylene glycol is recommended. Renew the disinfectant regularly.

9.6.8

Refrigerators, Freezers, and Dry Ice Chests

• Periodically check, clean, and defrost refrigerators, freezers, and dry ice chests to remove any containers of infectious or toxic materials that may have leaked or become broken during storage. Wear a lab coat, rubber gloves and respiratory protection while cleaning. Store breakable containers containing infectious material in leak-proof trays. 
   
• Clearly label all materials stored in refrigerators or freezers with the names of the materials, dates of storage, and the names or initials of the individuals storing the material. Secure labels with permanent transparent tape.
   
• With regard to refrigerators, attach a BIOHAZARD sign for pathogenic agents until the unit is decontaminated.
   
• Do not store food in refrigerators or freezers containing biohazardous materials.

9.6.9

Incubators

• For reasons of safety and quality control, decontaminate incubators on a routine basis. Also, store breakable containers containing infectious material in leak-proof trays when placing them into an incubator.

9.6.10

Storage of Pathogenic Specimens

• Store potentially infectious materials, including blood and other body fluids, in a leak- proof container that is identified with the biohazard term and symbol (red bags or red containers may be substituted for the label). 
   
• If outside contamination of the primary container is suspected or likely to occur, place the primary container in a leak-proof, labeled, secondary container.
   
• If the specimen could puncture the primary container, place it into a puncture-resistant, leak-proof, labeled, secondary container.

 

9.7

DISINFECTION AND STERILIZATION PROCEDURES

9.7.1

Scope and Responsibility

Decontaminate all apparatus, equipment, or waste contaminated with biohazardous materials before washing, reuse, servicing, shipping, or disposal. Each individual working with such material is responsible for proper decontamination.

9.7.2

Disinfectant Efficacy

Place all laboratory ware, and similar items such as pipettes, syringes, vials, serum bottles, centrifuge tubes, etc., contaminated with biohazardous agents, in covered containers and autoclave them prior to disposal. Wipe contaminated items too large for immersion in a liquid disinfectant with a disinfectant-saturated towelette before transporting for sterilization.

9.7.3

Autoclaves

• The NAS/NRC Committee on Hazardous Biological Substances in the Laboratory recommends that since infectious wastes have high levels of organic matter, sterilization of such wastes in gravity displacement autoclaves be performed at 121°C for a minimum of 60 minutes. 
   
• All autoclaves must bear a sign indicating the maximum working pressure.
   
• All double door autoclaves must have automatic door interlocks or indicator lights to prevent accidental removal of material from an autoclave before it has been sterilized.
   
• Do not leave material in an autoclave overnight without sterilizing it.
   
• Periodically remove and clean the screen in the autoclave drain line. 
   
• Place waste material containing infectious agents in autoclavable containers, clearly labeled with the universal biohazard symbol, or in a red or orange/red bag.
   
• Maintain a record of autoclave function. Use commercial ampules, which test autoclave function, to verify effectiveness every week. Run ampules with other material as directed by standard operating procedures. 
   
• Do not overfill autoclaves.

9.7.4

Disinfection of Work Surfaces in Biohazardous Materials Areas

• Disinfect work surfaces before and after each major operation.
   
• Disinfect work surfaces as soon as feasible when work surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials. Housekeeping staff are expressly prohibited from cleaning such spills or work surfaces.
   
• Remove and replace protective coverings, such as biosafety cabinet disposable liners, as soon as feasible when they become overtly contaminated.

9.7.5

Disinfection of Floors in Biohazardous Materials Areas

Damp mop floors in biohazardous materials areas periodically with a disinfectant and always after spills with infectious agents. Do not dry sweep, vacuum, or dry mop since such operations generate airborne dusts, which may be contaminated with biohazardous materials. Housekeeping staff are expressly prohibited from cleaning such spills.

9.7.6

Disinfection of Drains in Biohazardous Materials Areas 

Periodically flush all drains in biohazardous materials laboratories with disinfectant.

 

9.8

BIOHAZARDOUS WASTE DISPOSAL

9.8.1

Definition of Biohazardous Waste

Laboratory waste consists of combustible and non-combustible materials that are either:

• Non-contaminated and present no biological hazard, or,
   
• Contaminated with biohazardous materials, such as virus suspensions, cell extracts, radioactive material, inoculated animals, bedding, disposable supplies, etc., and represent varying degrees of hazard. OSHA specifically includes: contaminated sharps (items that can pierce skin); pathological and microbiological wastes containing human blood or other infectious materials; items that could release human blood or other infectious materials in a liquid state if compressed; and items that are caked with dried blood or other infectious materials and are capable of releasing airborne pathogens when handled. Note that some non-laboratory operations can generate contaminated waste, e.g., medical procedures, first aid, and others.

9.8.2

Contaminated Waste Handling

• Place waste comprised of or contaminated with potentially infectious materials in appropriate containers for disposal or processing as necessary. A biohazardous waste container is safe if it is: closable, puncture resistant, leak-proof, labeled with the biohazard symbol or red-bagged, and readily accessible. 
   
• If leakage of the primary container is suspected or likely to occur when moving the container of waste from the area of generation, or if outside contamination of the primary container occurs, place the primary container in a closed, leak-proof, labeled, secondary container. 
   
• Sterilize contaminated, noncombustible refuse such as broken glassware, empty bottles, disposable metal trash, etc., by autoclaving or with sterilizing gas before disposal. 
   
• Collect sharps including broken glass, hypodermic syringes and needles (disposable or non-disposable) that are being discarded in a rigid plastic or puncture proof sharps container for autoclaving and subsequent disposal. Use a separate, properly labeled sharps container for sharps contaminated with radioactive material. Do not pick up broken glass and similar sharps with your hands; use mechanical means such as tongs, forceps, dust pan, etc.
   
• Inspect and decontaminate trash receptacles intended for reuse which have a reasonable likelihood for becoming contaminated on a regularly scheduled basis. Decontaminate them as soon as feasible when they become contaminated.

9.8.3

Non-contaminated Waste Handling

• When size permits, non-contaminated dry combustible refuse such as writing paper, paper towels, cardboard cartons, etc., may be placed in plastic lined waste baskets for removal by the housekeeping staff.
   
• Sharps that are not contaminated with biohazardous materials (e.g., broken glassware) can still pose laceration/puncture hazards to persons handling the waste. To prevent such injuries, place all non-contaminated glass waste (broken or intact) into a closable, puncture-resistant container labeled uncontaminated sharps only. Biohazard labeling or red bagging is not necessary. Uncontaminated needles and syringes may also be disposed via these containers.

9.8.4

Aerosol Containers

Pressurized aerosol containers present a potential hazard and must not be placed in an autoclave or incinerator, since they may explode on heating. Discard aerosol containers with other non-burnable trash. Be certain that potentially contaminated cans are immersed or wiped down with an appropriate disinfectant before discarding.

9.8.5

Solvents and Flammable Liquids

Collect flammable liquids contaminated with infectious agents in safety containers and dispose of them via EHS. Small amounts of contaminated water-miscible flammables may be poured into a flammable waste can after suitable decontamination with a disinfectant.

9.8.6

Bulk Chemicals and Radioactive Wastes

See the Chemical Safety section of this manual and the Radiation Safety Manual for specific instructions.

9.8.7

Sewage

• Do not allow biohazardous substances under investigation to pass into the sewage system without prior sterilization. 
   
• Disposal of radioactive biohazardous material is very complicated. When isotopes are used with biohazardous materials or in animals, their disposal must be reviewed and approved by the Radiation Safety Officer.

9.8.8

Contaminated Air

• Filter air from safety cabinets before being exhausting to the atmosphere. HEPA filters are used for particulate matter and adsorbent filters for gases.
   
• Keep doors and windows of biohazardous materials laboratory rooms closed when an infectious agent is used.

9.8.9

Dead Animals

Place small dead animals previously inoculated with infectious agents in non-permeable containers marked "dead animals" and autoclave before disposal in properly marked containers. Store the animals in the cold until they are picked up.

9.9

EXPERIMENTAL ANIMALS

9.9.1

Identification of Experimental Animals

Mark and identify all animals and/or caging to be used in an experiment as one of the three following:

• Un-inoculated 
   
• Inoculated with non-hazardous materials 
   
• Inoculated with infectious or hazardous agents (identify the agent on the tag or label).

9.9.2

Cages

• Carefully handle cages housing animals to minimize the dispersion of dust from animal or cage refuse. Sterilize cages before reuse.
   
• Examine individual cages each morning, evening and at feeding times, so dead animals may be removed immediately and moribund animals treated appropriately.
   
• As in other areas of the biological laboratory, limit access to animal rooms to specifically authorized persons only.

9.9.3

Care and Handling of Experimental Animals

• Use protective clothing, gloves and a respirator or mask when feeding, watering, removing or otherwise handling live or dead animals. Under no circumstances should you place your bare hand into a cage containing animals.
   
• When animals are being dosed with biological agents, both the animal handler and technician administering the material must wear protective clothing, including a mask or respirator, unless the agent is being administered in a biosafety cabinet.
   
• Minimize movement of animals inoculated with biological agents. When it is necessary to move animals from the animal holding room to a laboratory, or from one laboratory to another, place the animals in a closed container, the external surface of which has been decontaminated.
   
• Segregate sick and infected animals as soon as possible to prevent the spread of infection. Ideally, each animal room should have a small isolated enclosure or isolation chamber in which to house sick animals.

9.9.4

Handling and Necropsy of Potentially Infectious Animals

• Only a qualified veterinary pathologist or experienced prosector must perform necropsies.
   
• Always wear rubber gloves, face protection, and a gown or apron as protection against skin contact.
   
• Immobilize animals adequately before the necropsy is begun, and wet the fur with a suitable disinfectant to reduce surface spread of viable organisms.
   
• Take care take not to contaminate specimen jars. Disinfect them before leaving the laboratory.
   
• At completion of the necropsy, place carcasses and all potentially contaminated material, instruments, etc., in suitable containers and disinfect them immediately with an acceptable germicide or by autoclaving.
   
• Do not remove papers or records from the necropsy area when the animals have been infected with Class 3 or 4 agents. Voice record findings and transcribe them later.

9.9.5

Animal Waste and Bedding

• Autoclave animal waste and cage bedding from animals that have been inoculated with biohazardous agents before disposal. Dispose of waste which is known or suspected to be contaminated with radioactive material in accordance with requirements established by the Radiation Safety Officer. 
   
• For transfer of potentially contaminated waste outside the animal laboratory, including disposable cages, place in a double-lined, leak-proof, sealable, red plastic bag. Depending on the degree of hazard, "dip sterilize" bags prior to placing them in covered metal containers for transfer.
   
• Place all dead animals in leak-proof, sealable bags for disposal. Autoclave animals inoculated with infectious agents in a red bag before removal from the building. 
   
• Treat all animal waste and bedding from experimentally inoculated animals as potentially containing microorganisms capable of causing subclinical or overt cross-infection in the same species, or one or more different species. Therefore, remove such animal wastes and bedding from cages or enclosures in a manner which minimizes the production of aerosols or distribution of such materials.

9.9.6

Animal Facility Housekeeping

• Immediately clean spilled animal waste and bedding, since waste litter can attract vermin, such as roaches, flies and stray rodents, which may spread disease.
   
• Frequently disinfect floors, walls, and cage racks, since they may become contaminated with animal excreta. Equip each common-activity area with its own set of housekeeping equipment, and disinfect it frequently. General housekeeping staff are expressly prohibited from cleaning animal facilities. 
   
• Do not allow buckets with waste water and mops to stand overnight. They can become a reservoir for organisms as the strength of disinfectant weakens. Never wring out mops with bare hands, since mops frequently harbor bits of broken glass or splinters.
   
• Keep hallways and aisles clear of clutter. Immediately remove disposable containers, shipping cartons, etc., and place them in proper waste receptacles.
   
• Disinfect gloves and boots after each use.

9.10

SHIPPING PATHOGENIC MATERIALS

9.10.1

General

There are special requirements for shipping biohazardous materials. These may include packaging, registration, labeling, identification on shipping papers, etc. Additional requirements may apply to imports/exports and to radioactive materials. Contact EHS for assistance.

9.10.2

Interstate Shipment of Etiologic Agents
The agents listed in 42 CFR Part 73.3 are regulated as part of the Anti-Terrorism and Effective Death Penalty Act of 1996. As spelled out in 42 CFR Parts 72 and 73, Catholic must register with an entity authorized by the Secretary of the Department of Health & Human Services to receive or ship these agents.

Registration - Request an Application 

The registration process includes:

• Sufficient information to show that the facility is capable of handling the agents at Biosafety Levels (BSL) 2, 3, or 4, depending upon the agent and work being done;
   
• Inspection of the facility;
   
• Issuance of a unique registration;
   
• Payment of fees; 
   
• Follow-up inspections to ensure the facility meets standards and recordkeeping requirements.

The requirements for BSL-2, 3, and 4 operations are contained in the CDC/NIH publication, " Biosafety in Microbiological and Biomedical Laboratories." 

CDC Form EA-101

Before the transferring any of these agents, complete CDC Form EA-101. The information required is:
 

• Name of the requestor and requesting facility;
   
• Names of the transferor and transferring facility;
   
• Names of the responsible facility officials for both the transferor and requestor;
   
• Requesting facility's registration number;
   
• Transferring facility's registration number;
   
• Name of the agent(s) being shipped;
   
• Use of the agent(s); and 
   
• Quantity of the agent(s) being shipped (number of containers and amount per container).

The form must be signed by the transferor and requestor, and the responsible facility officials representing both the transferring and requesting facilities.

Verification of Registration

Before transferring any of these agents, verify that: 
 

• The requesting facility has a valid, current registration;
   
• The requestor is an employee of the requesting facility; and
   
• The use of the agent by the requestor is correctly indicated on CDC Form EA-101.

If the information cannot be verified or there is suspicion that the agent may not be used for the requested purpose, immediately notify CDC.

Shipping/Receiving

Comply with any packaging and shipping requirements of all applicable regulations.

The requesting facility must acknowledge receipt of the agent by notifying the transferring facility by phone or electronic message within 36 hours of receipt, and provide a paper copy or facsimile transmission of receipt to the transferor within 3 business days of the receipt.

After acknowledgment of receipt, the transferor must provide a completed paper copy or facsimile transmission of CDC Form EA-101 within 24 hours to the registering entity.

Recordkeeping

A copy of CDC Form EA-101s must be retained by both transferring and requesting facilities for a period of five years after the date of shipment or for five years after the agents are consumed or properly disposed, whichever is longer.

Disposal

When an agent is no longer needed:
 

• Store it in accordance with prudent laboratory practices,
   
• Transfer it to another registered facility, or
   
• Destroy it on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.

When a transferred agent is consumed or destroyed, the facility must formally notify the registering entity. The formal notification must be noted on CDC Form EA-101 and a copy kept on record for five years.

9.11

BIO-SAFETY CONTAINMENT AND BIO-SAFETY LEVELS

9.11.1

Containment

The purpose of containment is to minimize or eliminate exposure of laboratory workers and the outside environment to potentially hazardous agents. The three elements of containment include laboratory practice and technique, safety equipment, and facility design. A risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.

The most important element of containment is strict adherence to safe practices and techniques. The Principal Investigator or other person in charge must train or arrange for training of individuals working in the lab on the hazards that will be encountered and on practices and techniques required to handle materials safely.

Each laboratory should develop biosafety operating procedures that identify hazards that will or may be encountered, and that specify practices and procedures that will minimize or eliminate exposures to these hazards.

9.11.2

Bio-Safety Levels

The Centers for Disease Control and Prevention (CDC) specifies four biosafety levels of laboratory operation in its publication Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, Feb 2007. The levels are combinations of practices, laboratory facilities, and safety equipment to be used to protect researchers, the public, and the environment. These four biosafety levels are summarized in the table below.   Additional standards for animal facilities may apply. Refer to the document above for more information on Animal Biosafety Level 1 through 4 (ABSL-1 through ABSL-4) requirements.   

Summary of Recommended Biosafety Levels for Infectious Agents

BSL	Agents	Practices	Safety Equipment (Primary Barriers)	Facilities  (Secondary Barriers)
1	Not known to consistently cause disease in healthy adults	Standard Microbiological Practices	None required	Open bench top sink required
2	Associated with human disease, hazard = percutaneous injury, ingestion, mucous membrane exposure	BSL-1 practice plus: • Limited access  • Biohazard warning signs  • "Sharps" precautions  • Biosafety manual defining any needed waste decontamination or medical surveillance policies	Primary barriers = Class I or II BSCs or other physical containment devices used for all manipulations of agents that cause splashes or aerosols of infectious materials; PPEs: laboratory coats; gloves; face protection as needed	BSL-1 plus: Autoclave available
3	Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences	BSL-2 practice plus:  • Controlled access • Decontamination of all waste  • Decontamination of lab clothing before laundering  • Baseline serum	Primary barriers = Class I or II BCSs or other physical containment devices used for all open manipulations of agents; PPEs: protective lab clothing; gloves; respiratory protection as needed	BSL-2 plus:  • Physical separation from access corridors  • Self-closing, double-door access  • Exhausted air not recirculated  • Negative airflow into laboratory
4	Dangerous/exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission	BSL-3 practices plus:  • Clothing change before entering  • Shower on exit  • All material decontaminated on exit from facility	Primary barriers = All procedures conducted in Class III BSCs or Class I or II BSCs in combination with full-body, air-supplied, positive pressure personnel suit	BSL-3 plus:  • Separate building or isolated zone  • Dedicated supply and exhaust, vacuum, and decon systems  • Other requirements outlined in the text

9.12

RECOMBINANT DNA RESEARCH

9.12.1

General

The National Institutes of Health (NIH) has developed guidelines that specify practices for construction and handling of recombinant deoxyribonucleic acid (DNA) molecules, and organisms containing recombinant DNA molecules. The Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) apply to all recombinant DNA research that is conducted at or sponsored by an institution that receives any support for recombinant DNA research from the NIH. It is the policy of CUA to comply with NIH guidelines.

9.12.2

Risk Groups

Biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans are classified under the following Risk Groups (RGs):

Risk Group 1 (RG1)	Agents that are not associated with disease in healthy adult humans
Risk Group 2 (RG2)	Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
Risk Group 3 (RG3)	Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)
Risk Group 4 (RG4)	Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)

A listing of agents under the various RGs may be found in the NIH Guidelines under Appendix B. 

9.12.3

Reviewing Bodies

Recombinant DNA Advisory Committee (RAC): A public advisory committee that advises the Department of Health and Human Services (DHHS) Secretary, the DHHS Assistant Secretary for Health, and the NIH Director concerning recombinant DNA research. The RAC consists of 25 members appointed by the DHHS Secretary or the secretary's designee.

The Office of Biotechnology Activities (OBA): The office within the NIH that is responsible for reviewing and coordinating all activities relating to the NIH Guidelines. 

Institutional Biosafety Committee (IBC): A committee established by CUA to review recombinant DNA work. The IBC must consist of at least five members that collectively have experience and expertise in recombinant DNA technology, the capability to assess the safety of recombinant DNA research, and the ability to identify any potential risk to public health or the environment. At least two members are to represent the interest of the surrounding community and must not be affiliated with CUA. A Biological Safety Officer (BSO) is mandatory when the institution is conducting high containment recombinant DNA research (Biosafety Level 3 or 4) or large scale research above 10 liters. The IBC meets on an as-needed basis.

9.12.4

Experiments Requiring Review and Approval

Experiments that require approval are divided into four categories:

1. Experiments that require Institutional Biosafety Committee Approval, Recombinant DNA Advisory Committee (RAC) Review, and NIH director approval before start-up.
   
   
   • Major actions under the NIH Guidelines
     
     The deliberate transfer of a drug resistant trait to microorganisms that are not known to acquire that trait naturally.
      
   • Human gene transfer experiments.
      
2. Experiments that require NIH/OBA and IBC approval before start-up
   
   
   • Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram of body weight.
      
3. Experiments that require IBC approval before start-up
   
   
   • Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or restricted agents as host-vector systems 
      
   • Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or restricted agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems
      
   • Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems
      
   • Experiments involving whole animals
      
   • Experiments involving whole plants
      
   • Experiments involving more than 10 liters of culture.
4. Experiments that require IBC notice simultaneous with initiation
   
   
   • Experiments involving the formation of recombinant DNA molecules containing no more than two-thirds of the genome of any eukaryotic virus
      
   • Experiments involving whole plants.
      

9.12.5

Exempt Experiments

1. Those that are not in organisms or viruses
    
2. Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent
    
3. Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means
    
4. Those that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species)
    
5. Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent
    
6. Those that do not present a significant risk to health or the environment as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment.

 

9.13

PUBLIC HEALTH SECURITY AND BIOTERR0RISM PREPAREDNESS AND RESPONSE ACT

Under this new law, all colleges and universities that possess select agents, which are certain biological agents and toxins (see 42 CFR Part 72 Appendix A for the current list) need to register with the Secretary of the U.S. Department of Health and Human Services. The law requires Health and Human Services and the Department of Agriculture to develop new lists of biological agents and toxins that have the potential to pose a severe threat to the public's health and safety. The lists are to be reviewed at least biennially. The Secretary of HHS will by regulation establish standards and procedures governing the possession and use of the agents and toxins. This will include standards for transfer of the agents, training in handling the agents and toxins, and assurance that proper laboratory facilities exist to store the agents. Safeguards to prevent unauthorized access will be established. The Secretary of HHS will maintain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons possess, use, or transfer, and information characterizing the agents and toxins. The new law also requires prompt notification of the release of a select agent outside of the biocontainment area, or of theft or loss of a select agent. Thus universities must keep comprehensive inventories of select agents if they do not already do so. The university will be required to submit the names and other identifying information for individuals who the university determines have a legitimate need to handle or use the toxins. The university must also deny access to the agents/toxins by restricted persons. The definition of restricted includes a person who: 

• Is under indictment for a crime punishable by imprisonment for a term exceeding 1 year; 
   
• Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
   
• Is a fugitive from justice;
   
• Is an unlawful user of any controlled substance;
   
• Is an alien illegally or unlawfully in the United States;
   
• Has been adjudicated as a mental defective or has been committed to any mental institution; 
   
• Is an alien who is a national of a country that has repeatedly provided support for acts of international terrorism. The countries currently on the list are Cuba, Libya, Iran, Iraq, North Korea, Sudan, and Syria or 
   
• Has been dishonorably discharged from the Armed Services.