Policy No. 706
4/13/07
NCI-FREDERICK RESEARCH MATERIAL HANDLING AND USE POLICY
POLICY
This policy establishes requirements for all laboratories handling non-clinical and clinical ?research scale? work at the National Cancer Institute at Frederick (NCI-F) with known or suspected pathogens, toxins, recombinant DNA, Select Agents and other biological materials, and other potentially infectious material (OPIM). All work meeting one or more of these categories will be conducted at an appropriately assigned biocontainment level laboratory in accordance with Centers for Disease Control and Prevention (CDC) guidelines and recommendations, and the guidelines issued by the Environment, Health and Safety Program (EHS) office. The Biological Safety Officer has the authority to determine and mandate the minimum required laboratory biosafety level, according to the information obtained from the registration form, with concurrence from the NCI-F Institutional Biosafety Committee (IBC).
DEFINITIONS
Biosafety Level (BSL) - designates a combination of laboratory practices and techniques, safety equipment and laboratory facilities designed to minimize the potential for exposure to pathogens and/or other biohazards.
Biosafety Level 2 (BSL-2) - Biosafety Level 2 practices, equipment, and facilities are applicable to clinical, diagnostic, teaching, and other facilities in which work is done with the broad spectrum of indigenous moderate-risk agents present in the community and associated with human disease of varying severity. With good microbiological techniques, these agents can be used safely in activities conducted on the open bench, provided the potential for producing aerosols is low.
Biosafety Level 2* (BSL-2*) - indicates the use of BSL-3 practices and procedures in a laboratory that meets the BSL-2 facility requirements specified in CDC/NIH Biosafety in the Microbiological and Biomedical Laboratories , 4 th edition.
Biosafety Level 3 (BSL-3) - Biosafety Level 3 practices, safety equipment, and facilities are applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents where the potential for infection by aerosols is real and the disease may have serious or lethal consequences.
Concentrated virus - viral cultures containing >10 8 TCID 50 /ml.
HIV Genome - is the entire genetic complement of HIV.
Inactivated virus - a virus that has been rendered entirely non-infectious by chemical or physical treatment or genetic transformation.
Other Potentially Infectious Material (OPIM) ?
- The following human body fluids:
- Semen
- Vaginal secretions
- Cerebrospinal fluid (fluid surrounding the brain and spinal cord)
- Synovial fluid (fluid surrounding bone joints)
- Pleural fluids
- Pericardial fluid
- Peritoneal fluids
- Amniotic fluids
- Saliva in dental procedures
- Any body fluid that is visibly contaminated with blood
- All body fluids in situations where it is difficult or impossible to differentiate between body fluids
- Any unfixed tissue or organ (other than intact skin) from a human, or non-human primate (living or dead)
- HIV-containing cell or tissue cultures, organ 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.
- Any pathogenic microorganism
- Human cell lines
Production Facility - a facility engaged in industrial-scale, large-volume or high-concentration production of virus.
PROCEDURE
The following procedures outline responsibilities for investigators and their research personnel, when acquiring and/or manipulating the following types of research materials:
Work with pathogenic virus, attenuated strains, and human tissues and cell line materials containing infectious virus
- Recent patient viral isolates and human tissues known to contain infectious virus: All handling of this material and any experiments involving this material or the viruses derived from it in which the virus has not been specifically inactivated will be conducted at the BSL-2* level. Because such samples are known to be contaminated with other human pathogens, anyone handling such material should take measures appropriate to avoiding exposure with (and/or inactivate) all of the potential pathogens.
- Well-characterized lab strains and complemented vector systems in which there is a reasonable expectation that recombination can give rise to replication-competent virus will be used at BSL-2*. This includes all complemented systems in which all of the components used to propagate the vector are derived from infectious material. Experiments involving such viruses and/or vectors will normally be conducted at the BSL-2* level.
- Virus-derived vector systems in which there is no reasonable expectation that recombination can generate a replication competent virus. Examples of such systems include viral vectors in which an essential gene has been irreversibly disrupted and the complementing genes provide no reasonable possibility of recombination to produce a replication-competent virus. Such experiments can be conducted at the BSL-2 level.
Large scale work with viruses
- This portion of the policy is for work involving the production of virus at levels above that required for routine research activities. Virus being propagated at industrial-scale, large-volume, or high concentration will require as a minimum BSL-2* containment augmented by special engineering controls designed to compensate for increased volumes and viral titers.
Work with recombinant DNA
- Experiments in which part or all of the viral genome is synthesized in vitro or propagated as a plasmid in E. coli or some other prokaryotic or lower eukaryotic (e.g. yeast) host do not require BSL-2 containment . However, viral DNA that contains a complete, non-permuted genome has the potential to cause infection under certain circumstances, such as by ingestion or wound contamination. Therefore, r esearchers are strongly cautioned about work with such reagents, both in the prokaryotic and lower eukaryotic (e.g. yeast) hosts and particularly when DNAs containing a complete non-permuted viral genome are prepared in a pure, concentrated state. Every effort should be made to work with DNAs that contain either partial copies of the viral genome or permuted viral genomes whenever it is experimentally feasible.
RESPONSIBILITIES
Principal Investigators and/or Supervisors
- Register all work with human pathogens, human blood or other potentially infectious materials, to include human cell lines and recombinant DNA with the Biosafety office (x1451).
- Renew registrations every 3 years. Modifications to previously approved registrations shall be submitted to and approved by the IBC prior to commencement of modified activities or conditions.
- Acquire the information needed to recognize and control infectious agents in the laboratory. Attend required training as needed. EHS can facilitate in assessing the requirements. Tables at the following Web sites indicate in-house training assistance:
http://home.ncifcrf.gov/ehs/ehs.asp?id-105
http://home.ncifcrf.gov/ehs/ehs.asp?id-34
- Verify that all regulatory requirements for material acquisition, transfer, and use are completed and approved by the appropriate regulating entity.
- Provide EHS with a proposed detailed standard operating procedure (SOP) to include laboratory practices and engineering controls that prevent or limit occupational exposure to infectious agents.
- Inform supervised employees listed on the principal investigator?s registration forms of the potential hazards associated with the use of infectious agents in the laboratory.
- Provide to EHS signed copies of the approved SOP for all personnel, the safe work practices and procedures for all employees in their labs, informing EHS of any changes in personnel status and/or protocols, and notifying OHS of employee eligibility for medical surveillance.
- Instruct employees in safe laboratory practices and the use of protective equipment, and in the procedures for dealing with accidents involving infectious agents.
- Notify the Biological Safety Office of any procedural changes in laboratories working with material covered under this policy.
- Ensure the implementation of the Bloodborne Pathogen Exposure Control Plan.
Institutional Biosafety Committee (IBC)
Review and approve all work with materials as defined in this policy.
EHS
- Maintain a registry of all laboratories working with potentially hazardous biological materials.
- Review all SOPs involving safety procedures.
- Keep copies of SOPs signed by each employee.
- Maintain records of additional initial training provided by supervisors.
- Inspect all laboratories at least annually, for compliance with this and other applicable policies. Inspect Biosafety Level 3 facilities at least every 6 months.
- Add employees to the appropriate medical surveillance programs through IBC registrations or request by the PI or supervisor.
- Conduct training programs to educate and implement methods for the safe handling of infectious agents.
- Assist the investigator in the design of the laboratory and the selection of laboratory practices and engineering controls that ensure a safe working environment.
- Provide technical guidance to any person responsible for matters pertaining to laboratory safety
OHS
- Manage surveillance programs
- Provide first aid kits and supplies.
- Manage any potential laboratory exposures.
- In conjunction with EHS, train affected individuals and groups on specific medical monitoring programs.
Employees
- Comply with the policies and procedures established by the NCI-F Institutional Biosafety Committee.
- Read and comply with the SOPs associated with their work.
REFERENCES
CDC/NIH Biosafety in the Microbiological and Biomedical Laboratories , HHS Publication No. (CDC) 93-8395, 4th edition.
Cello J, Paul AV, Wimmer E. Chemical synthesis of poliovirus cDNA: generation of infectious virus in the absence of natural template. Science . Aug 9; 297(5583):1016-1018, 2002.
Fleming D. et al., Lab Safety: Principles and Practices , 1995, pp.42.
NCI-Frederick Exposure Control Manual .
NIH Guidelines for Research Involving Recombinant DNA Molecules .
OSHA 29 CFR 1910.1030 Occupational Exposure to Blood Borne Pathogens; Final Rule , Dec. 6, 1991.
Stedman's Medical Dictionary , 26th edition.
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