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GUIDELINES FOR ACTIVITIES INVOLVING RECOMBINANT DNA
AND/OR MICROBIOLOGICAL BIOHAZARDS

 These guidelines describe the responsibilities of and procedures for University of Mississippi Medical Center (UMC) personnel engaged in activities using recombinant DNA and/or microbiological agents that pose a potential health risk to humans. 

Responsibilities
Recombinant DNA Biohazards
Microbiological Biohazards
Registration Exceptions

Bloodborne Pathogens
Clinical Laboratories
University Hospitals and Clinics

Activity Registration see Checklists
Laboratory Certification
Standardized Plans [Waste Disposal, Training and Emergency]

Solid medical/infectious waste
Liquid medical/infectious waste
Hazardous-appearing non-hazardous waste

Training Plan

BSL-1
BSL-2
BSL-3
BSL-4

Emergency Plan
Animals
Inspection
Addition of Personnel
Shipment of biological materials and dry ice
Additional Resources
Forms

RESPONSIBILITIES

Supervisors of such activities (i.e., principal investigator, course instructor, and laboratory director) are responsible for the following. (1) Determining whether or not activities under their direction involve recombinant DNA or microbiological biohazards. (2) Classifying the biohazard risk group and determining the biosafety level at which the activity should be conducted. (3) Registering the activity with and seeking approval from the UMC Institutional Biosafety Committee (IBC). (4) Complying with federal and institutional guidelines for safe handling of biohazard materials. (5) Informing personnel of risk potential and providing them with adequate training to minimize their exposure.

The IBC is responsible for the following. (1) Verifying the risk group classification and biosafety level required for activities involving biohazards. (2) Assuring that all supervisors are aware of and comply with laboratory safety practices commensurate with the prescribed level of biosafety, have adequate containment equipment and facilities, and train their personnel.

The UMC Environmental Health and Safety Department (EHS) responsible for student, employee, patient and visitor health and safety and 2) supports the IBC through a Biosafety Officer who provides training, certification and facility inspections designed to prevent exposure incidents and injury, identify and eliminate hazards and establish safe work practices and procedures. EHS staff provides assistance in areas besides biosafety.

Biohazards are divided into two broad categories; recombinant DNA and other microbiological biohazards.  Microbiological biohazards include (1) activities that involve propagation or manipulation of microorganisms that are pathogenic in humans, as well as (2) activities that involve handling of tissues or cells that may harbor pathogenic microorganisms.

RECOMBINANT DNA BIOHAZARDS

Manipulation or propagation of recombinant DNA must be done in accordance with the current National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules(“NIH guidelines”)

Supervisors must consult the NIH guidelines to determine whether or not their activities are covered by the guidelines and, if so, what biosafety level is required for either in vitro manipulation of recombinant DNA or its in vivo propagation in living cells and organisms, including transgenic animals. UMC requires IBC registration of all exempt and covered activities involving recombinant DNA to confirm proper classification of the activity and assure compliance with prescribed laboratory safety practices and use of containment barriers. When applicable, the IBC will assist in acquiring approval from higher authorities such as the NIH Office of Recombinant DNA Activities.

MICROBIOLOGICAL BIOHAZARDS

Manipulation or propagation of microbiological organisms (parasitic, fungal, bacterial, rickettsial and viral agents) that pose a potential health risk to humans must be done in accordance with current Centers for Disease Control (CDC) Biosafety in Microbiological and Biomedical Laboratories (“CDC guidelines”)
Supervisors must consult the CDC guidelines to determine the risk group and biosafety level required for handling either infectious agents or vertebrate animals infected with such agents.  The CDC guidelines cover a limited number of agents; a more extensive list can be found in NIH guidelines (above), Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard.  Supervisors must register activities involving covered agents with the IBC to assure those applicable laboratory safety practices and recommended containment equipment and facilities are in place and to obtain the proper level of approval prior to initiation of the experiments. 

REGISTRATION EXCEPTIONS

Bloodborne Pathogens
Activities whose hazard potential is limited to handling clinical specimens (unfixed human tissue, body fluids, etc.) DO NOT require IBC registration. However, personnel engaged in such activities must be registered with the Bloodborne Pathogens Coordinator in Student/Employee Health (extension 41191) and comply with the UMC’s Occupational Bloodborne Pathogens Control Plan. CDC guidelines specify that clinical specimens should be handled under Biosafety Level 2 (BSL-2) containment.

Clinical Laboratories
Activities in clinical laboratories (such as specimen handling and testing) DO NOT require IBC registration. Personnel must adhere to practices and procedures requisite for certification by the College of American Pathologists.  

University Hospitals and Clinics
Activities generally associated with diagnosis and treatment of patients DO NOT require IBC registration. The Infection Control Committee is charged with surveillance of inadvertent hospital infection potentials, the analysis of actual infections, the promotion of a preventative and corrective program designed to minimize infection hazards, and the supervision of infection control in all phases of the hospital’s activities.
 
ACTIVITY REGISTRATION

 

If the activity requires institutional approval (Vice Chancellor for Health Affairs’ signature for grant application, contract, material transfer agreement, etc.), submit IBC-required documents concurrently with a UMC Transmittal Form to the Office of Research (telephone 55000). 

If the activity DOES NOT require institutional approval (for example, use of pathogenic microorganisms in a teaching laboratory), submit the required documents directly to the IBC Chair.

The IBC meets once each month, typically on the last Friday of the month. To be listed on a meeting’s agenda, registration documents must reach the IBC Chair before the 15th day of that month.

If the IBC approves the registration, the supervisor will receive a signed copy of either the Registration Form or Update & Modification Form. If the registration is disapproved, the supervisor will receive a memo detailing deficiencies and outlining what steps must be taken to acquire approval. Registration approval DOES NOT automatically grant permission for work to commence (see Laboratory Certification).

Animals naturally containing or artificially infected with either recombinant DNA or microbiological biohazards must be housed in UMC’s Laboratory Animal Facilities (41385). 

LABORATORY CERTIFICATION

For activities that are either exempt from federal guidelines or require BSL-1 containment, work may commence as soon the supervisor acquires IBC approval of activity registration.

For activities that require containment at BSL-2 or higher, work may NOT commence until the IBC conducts a laboratory certification inspection. The purpose of this inspection is to ensure that practices, procedures and barriers are in place for compliance with CDC/NIH guidelines for the requisite biosafety level. The IBC Chair will provide a memo explaining how to schedule the inspection and other supplemental information. 

STANDARDIZED PLANS for [Waste Disposal, Training and Emergency]

Below are minimal acceptable standards for waste disposal, training, and emergency plans for activities involving biohazards. Supervisors of such activities (i.e., the principal investigator, course instructor, or laboratory director) are responsible for determining whether or not these are sufficient for their work and ensuring that personnel are adequately informed and trained. With IBC approval, these plans may be modified to suit specific project needs.

Waste Disposal Plan

UMC has a written waste management plan; Management of Medical/Infectious Waste; a copy can be obtained by calling Environmental Health and Safety (41980).

The waste management plan includes the following elements: (1) designation of medical/infectious waste; (2) handling (segregation, packing and storage) of medical/infectious waste; (3) destruction (transport, treatment and disposal) of medical/infectious waste; and 4) related matters such as staff training. 

Chemical waste, regardless of whether or not deemed a biohazard must be disposed of through the Chemical Safety Office (call 41981). All radioactive waste must be disposed of through the Radiation Safety Office regardless of whether or not deemed a biohazard (41078).

All glass slides, slide covers, and test tubes that appear to be medical/infectious waste must be disposed of in sharp containers. All chemical or radioactive sharps must be collected in puncture proof sharp containers and disposed of through the Chemical Safety Office or the Radiation Safety Office.

Waste disposal options include:

Solid medical/infectious waste and anything that appears to be medical/infectious waste can be disposed of without treatment in approved red Medical Waste containers (supplied with the universal biohazard emblem, lined with 1.5 mil red plastic bags that have the biohazard emblem). These containers can be acquired from Environmental Services (extension 55239) which, upon notification, will provide waste pick-up and container replacement. Investigators are responsible for on-site container management such as ensuring that normal trash is not put therein and calling for pick-up service. Pick-up should be requested whenever one of the following occurs: (1) the container is full; (2) waste has been stored in the container for 7 days above 6oC; or (3) waste has been stored for 90 days at 0oC or below.  

Liquid medical/infectious waste, such as biological stocks and used culture media, must be decontaminated before disposal using an approved process. Two options are available: (1) Autoclaving at 121oC and 15 psi for either 50 minutes if waste containers are on metal trays/pans or 75 minutes if on plastic pans. (2) Chemical disinfecting by adding 1 part household bleach to 9 parts liquid waste (final concentration 10% by volume), mix and let stand at least 15 minutes. Other acceptable chemical disinfectants are listed in Management of Medical/Infectious Waste. Decontaminated liquids may then be disposed of through the sanitary sewer system, followed by copious amounts of water unless they contain hazardous chemicals such as ethanol, methanol, bleach, etc.

Hazardous-appearing non-hazardous waste (i.e., petri dishes with agar, agar on which non-pathogenic organisms have been grown, tissue culture flasks, etc.) may be disposed of without treatment in approved red Medical Waste containers (see Solid Medical/Infectious Waste, above). Alternatively, this waste may disposed of as general solid waste only if rendered unrecognizable, for example, by autoclaving plasticware and defacing all biohazard emblems on containers and bags.

Training Plan

Supervisors are responsible for instructing and training all personnel involved in any activity that includes biohazards. Training must include, but need not be limited to, standard and special microbiological practices and procedures, and proper use of safety equipment (primary barriers) and laboratory facilities (secondary barriers) to ensure safety of personnel, and containment of the biohazard during routine work or if accidents occur. Practices, techniques and barriers for each biosafety level (BSL-1, BSL-2, BSL-3 and BSL-4) are detailed in:

Biosafety in Microbiological and Biomedical Laboratories (“CDC guidelines”) and
 
NIH Guidelines for Research Involving Recombinant DNA Molecules (“NIH guidelines”)

These guidelines also give recommendations of when health surveillance of project personnel is advised.

Project personnel must read pertinent sections of applicable guidelines. In addition to training outlined therein, the IBC requires the following:

BSL-1 Initial personnel training should be reinforced by retraining and updates whenever necessary. This could be accomplished during annual employee evaluations.

BSL-2 Initial personnel training must include familiarization with practices, procedures and barriers described for BSL-2 in the guidelines. Employees should be able to clearly state the nature of the risk, explain how to avoid exposure, and know what to do in case of accidental exposure. Employees must complete and sign a Statement of Informed Consent; copies should be (1) sent to the IBC, (2) maintained by the supervisor and (3) placed in the laboratory’s Biosafety Manual before work with biohazards begins. 

Annual retraining is required; the content and format may vary to suit each lab. For example: (1) attend continuing education seminars periodically sponsored by the IBC; (2) view training videos available from the IBC on topics such the design and proper use of biosafety cabinets and (3) participate in supervisor-conducted hands-on retraining or review of literature pertinent to their activity. The IBC will distribute an Annual Biosafety Update Form to document who was retrained and how this was accomplished.

BSL-3 All BSL-2 Requirements must be met; however, initial personnel training should be rigorous and routinely subject to examination. Annual retraining by the supervisor is required and must include a demonstration of personnel proficiency in the use of standard and special microbiological practices and procedures, proper use of primary and secondary barriers and knowledge of emergency procedures. The IBC will distribute an Annual Biosafety Update Form to document who was retrained and how this was accomplished.
 

BSL-4 Contact the IBC Chair.

Emergency Plan

Any group working with a known or potential biohazard shall have an emergency plan that describes procedures to be followed upon accidental contamination of personnel or the environment.  For activities requiring containment at BSL-2 or higher, a written emergency plan must be on file with the IBC and one copy maintained in the laboratory’s Biosafety Manual. Exceptions and modifications requisite for specific types of activities must be approved by the IBC. Supervisors are responsible for ensuring personnel are knowledgeable of and trained in all emergency procedures, including the requirement to file an incident report.

  • Any overt or suspected contamination of personnel or environment must be reported to the project supervisor or other emergency contact person listed on the laboratory biohazard sign.
  • In the event of personnel exposure, immediately decontaminate exposed skin by vigorously washing with iodine or antimicrobial soap for 15 minutes. If eyes are contaminated, flush them with clean water, preferably at an emergency eye wash station for at least 15 minutes. Immediately following decontamination, report the exposure incident to Student/Employee Health (Room N-128, Monday-Friday, 7:30 AM - 4:00 PM, extension 41185) which will provide examination, treatment and record keeping of the incident. That office will also determine if follow-up treatment or additional consultation (in-house or external) is required. The UMC Emergency Room can provide after-hours examination and treatment; however, personnel must still notify Student/Employee Health of the incident as soon as possible.
  • Minor spills on equipment or work surfaces should be picked up with absorbent material (paper towel) and the surface decontaminated with disinfectant (i.e., fresh 10% bleach, 70% ethanol). For larger spills, add concentrated disinfectant to the spill (i.e., 1 part bleach for 9 parts spilled liquid), wait 1 hour then pick up and dispose of liquid/solid waste as specified in the Waste Disposal Plan. This waste may now contain chemical reagents that must be disposed of through the Chemical Safety Office (41981).
  • Accidents resulting in aerosols require immediate evacuation of the room for a period of one hour before lab personnel re-enter the lab to clean up and decontaminate the exposed area. In the event of the release of an appreciable amount of aerosol outside the biosafety cabinet, contact Physical Plant (extension 41420) and request airflow to and from that room be restricted until decontamination and clean-up have been completed. DO NOT request airflow restriction in BSL-3 rooms designed to operate under negative pressure with HEPA-filtered exhaust.
  • Space decontamination can be achieved with ultraviolet lights in rooms so equipped. The IBC can assist in arranging special space decontamination needs.

ANIMALS

When vertebrate animals are involved, UMC’s Occupational Health and Safety Program for Animal Handlers must be on file with the IBC and maintained in the laboratory’s Biosafety Manual. If non-human primates are involved, UMC’s Biosafety Level Containment Requirements for Procedures Working with Macaques must also be included.

 

INSPECTIONS

Laboratories and other facilities in which biohazards are used or stored are subject to random inspection by members of the IBC. After an inspection, the supervisor will be notified as to whether or not violations were observed.  Failure to correct violations expeditiously will result in withdrawal of IBC approval.

 

ADDITION OF PERSONNEL

Personnel who join an activity subsequent to IBC registration must be adequately trained by their supervisor and file a Statement of Informed Consent BEFORE they commence work with biohazards.

SHIPMENT OF BIOLOGICAL MATERIALS AND DRY ICE

Federal regulations (49 CFR Parts 171-180) outline shipping requirements for hazardous materials including biological, radioactive and corrosive materials, dry ice, compressed gasses, flammable liquids and solids, oxidizers, and poisons. Please visit the GPO Access website and select Title 49 and under Hazardous materials regulations, select the appropriate number 171-180 to get information.
 
If transported by commercial carriers (FedEx, DHL, UPS), shipments are regulated by the Department of Transportation’s (DOT’s) Office of Hazardous Materials Safety  and/or the International Air Transport Authority (IATA). When materials are shipped out of the country, items that may not be considered hazardous in the United States may be classified as hazardous in other countries. To comply with international shipping regulations, these materials must be properly classified, documented, packaged, and handled. For shipments of biological and radioactive materials, transport or export permits and/or authorization may be required in advance of shipment.
 
Federal law requires that anyone who is involved in or responsible for preparing or transporting a hazardous material must have DOT training and certification. No one is exempt from these federal transportation requirements. Failure to comply can result in imprisonment of the individual responsible for shipment and substantial fines to both that individual and the institution. Compliance monitoring has significantly increased in response to threats of bioterrorism.
 
Supervisors of projects using either recombinant DNA or microbiological biohazards are the individuals responsible for shipping regulations compliance. The UMC Shipment of Biological Materials Manual provides guidance for shipment of biological/hazardous materials. Environmental Health and Safety can provide training and on-line certification of individuals responsible for shipment of biological/hazardous materials. State and federal laws limit shipping services to activities that are considered official UMC business.

Contact the Biological Safety Officer Yolanda Griffin at (5-5074) for more information regarding training, certification and services.

ADDITIONAL RESOURCES

The following are linked to web sites that contain useful information.
American Biological Safety Association
CDC Office of Health and Safety
CDC Select Agent Program
Institute for Laboratory Animal Research
NIH Office of Biotechnology Activities
Occupational Exposure to HIV
Occupational Health and Safety Administration

The IBC Chair can provide access to:
Issues of the Journal of the American Biological Safety Association
Eagelson Institute Training Videos
·Introduction to Biological Safety Cabinets
Part I.  What They Are & How They Work
Part II. The Different types
·Safe Use of Biological Safety Cabinets
·Safe Use of Chemical Fume Hoods
Training videos for working with macaques.
           
FORMS

Requirements for IBC Registration