Biosafety Manual - University Of Notre Dame
BiosafetyManualMay 2010
UNIVERSITY OF NOTRE DAME BIOSAFETY MANUALTABLE OF CONTENTS1.02.03.04.0PurposeScopeAcronyms and DefinitionsResponsibilities41Institutional Biosafety Committee (IBC)4.2Risk Management and Safety (RM&S)4.3Office of Research (OR)4.4Institutional Animal Care and Use Committee (IACUC)4.5Principal Investigator (PI)4.6Laboratory Worker5.0Regulatory Compliance6.0Summary of Biosafety Levels7.0Protocol Submission and Review8.0Training9.0Containment10.0Recombinant DNA11.0Use of Animals12.0. Laboratory Biosafety Manual - CDC BMBL and NIH Guidelines13.0BL 3 Facility - Tests and Certifications14.0Biosafety Cabinets14.1Certification of Cabinets14.2General Guidelines14.3Electricity Failure During Use14.4Laminar Flow Hoods15.0Incubators16.0Disposal of Infectious Materials17.0Reporting of Exposure Incidents and Spills18.0Packaging & Shipment of Biological Materials19.0Maintenance/Repair & Disposition of EquipmentAPPENDIX A ReferencesAPPENDIX B Blood Borne Pathogens ProgramAPPENDIX C Infectious Waste Disposal GuideAPPENDIX D Guidelines for the Use of DisinfectantsAPPENDIX E Laboratory Biosafety Level Critera per CDC/NIH BMBLSOPsBL3-101 General BSL-3 Laboratory PracticesBL3-102 Shipping and Receiving for BSL3BL3-103 Spill Response in the BSL-3BL3-104 Decontamination and Maintenance Procedures for BSL3BL3-105 Medical and Facility emergencies in BSL3BL3-106 Training and Certification of Operators in BSL3BL3-107 Equipment operationBL3-108 MDR TBBL3-109 RadioactivityLAB SPECIFIC SOPSPage Number1113334445566891014141515151616161717171718
1.0PURPOSETo ensure a safe working environment for all University activities and for compliance with all applicablefederal, state, and local regulations concerning the use of biological agents, biological toxins, selectagents, and recombinant DNA in the laboratory The precautions and guidelines in this Biosafety Plan arecompatible with current knowledge and regulations.2.0SCOPEThis Biosafety Manual applies to all laboratory employees working in laboratories that use biologicalagents, biological toxins and recombinant DNA.3.0ACRONYMS AND DEFINITIONSABSL -Animal Biological Safety LevelBL - Biological Safety LevelCDC - Center for Disease ControlESPM - Equipment Surplus Property ManagementHEPA - High-Efficiency Particulate AirIACUC - Institutional Animal Care and Use CommitteeIBC - Institutional Biosafety CommitteeMSDS - Material Safety Data SheetNIH - National Institutes of HealthNSF - National Sanitation FoundationNRC - National Research CouncilORDA - Office of Recombinant DNA Activities (NIH)OSHA - Occupational Safety and Health AdministrationPI - Principal InvestigatorRAC - Recombinant DNA Advisory Committee (NIH)rDNA - Recombinant DNARM&S - Risk Management and SafetyOR - Office of ResearchBiological Toxin - A colloidal proteinaceous poisonous substance that is a specific product of themetabolic activities of a living organism and is usually very unstable, notably toxic whenintroduced into the tissue, and typically capable of inducing antibody formation.Biosafety Level 3 Facility - A facility specifically designed for the use of Class 3 organisms.Formerly referred to as a P3 facility.Blood-Borne Pathogens - Pathogenic microorganisms that are present in human blood that cancause disease in humans. These pathogens include, but are not limited to HBV and HIV.Baseline Serum - A blood sample drawn from a human for archiving for future reference by aphysician.University of Notre DameBiosafety ManualMay 2010Page 1
Class I Biosafety Cabinet - An enclosure with an inward airflow through the front opening.Provides protection for the worker and the laboratory environment but not to product beingutilized in the cabinet.Class II Biosafety Cabinet An enclosure with an inward airflow through the front opening.Provides protection to the worker, the environment, and the product being utilized in the cabinet.Class 1 Organisms - Oganisms not known to cause disease in healthy adults.Class 2 Organisms - Organisms associated with human disease, infectious throughinoculation ingestion, mucous membrane exposure.auto-Class 3 Organisms - Indigenous or exotic agents with potential for aerosol transmission; diseasemay have serious or lethal consequences.Containment - Used to describe safe methods for managing infectious agents in the laboratoryenvironment where they are being handled and maintained. The purpose of containment is toreduce or eliminate exposure of laboratory workers, other persons, and the outside environmentto potentially hazardous agents.Host - Organism in which the rDNA replicates.Negative Airflow - Directional airflow from areas exterior to a laboratory into the laboratory.Primary (p) Containment - methods to protect the internal laboratory environment.rDNA - DNA prepared by breaking up and splicing together DNA from several different speciesof organisms.rDNA Insert - That (those) strand(s) of foreign DNA being inserted into the host/vector.Secondary (s) Containment - methods to protect the environment external to the laboratory.Select Agent - is defined by CDC and USDA as biological agents or toxins deemed as a threat tothe public, animal or plant health, or to animal or plant products.Sharps - Any object that can penetrate the skin, e.g., needle, scalpel, knife, etc.Vector - Carrier used to introduce rDNA into the host system and that facilitates replication.University of Notre DameBiosafety ManualMay 2010Page 2
4.0RESPONSIBILITIES4.1Institutional Biosafety Committee - The Institutional Biosafety Committee (IBC),a University Committee appointed by the President, has the ultimateresponsibility for biosafety and shall establish regulations and guidelines, asdefined in this Biosafety Manual, for the safe use of biohazardous materials at theUniversity of Notre Dame. The duties of the IBC are:1.2.3.4.5.6.4.2Oversee all research and teaching activities involving biohazardous agentsincluding review and approval prior to initiation, annual reviews andupdates, reviews of laboratory safety equipment and procedures, andcertification of compliance with all applicable rules and regulationsgoverning the use of biohazardous materials.Advise University faculty, staff and students in matters related tobiohazards and biosafety with their respective areas of responsibility.Develop, recommend, and implement policies and procedures forbiological risk assessment and biological risk reduction throughout theUniversity.Develop emergency plans for the containment and resolution of accidentalspills and other related emergencies with an emphasis on risk reduction,personnel protection, and environmental protection.As an agent of the Institution, ensure that all principal investigators aresufficiently trained in appropriate containment practices, secondarycontainment procedures, accidental spill containment, and theirresponsibilities as principal investigators.Conduct investigation of serious violations or problems and to makerecommendations to the Faculty member, Department Chair, Dean and/orProvost.Risk Management and Safety Department (RM&S)1.2.3.4.5.6.Provide industrial hygiene and safety support for all laboratory operations.Transport and dispose of all infectious waste in compliance with allapplicable federal, state, and local ordinances.Assist, as necessary, in the emergency response, cleanup, anddecontamination of biological spills and accidents.Shut down research or teaching activities in laboratories that do not meetthe necessary standards for the biosafety level required for the agentsbeing used.Maintain compliance with all shipping requirements for biological agentsand toxins including certifying individuals to ship specific HazardousMaterials or Dangerous Goods.Provide assistance in determining shipping requirements for all biologicalsamples and be responsible for shipment if the sample falls under thedangerous goods classification.University of Notre DameBiosafety ManualMay 2010Page 3
7.8.4.3Office of Research (OR)1.2.3.4.4Provide the necessary liaison between Principal Investigators, theInstitutional Biosafety Committee, granting agencies, and regulatoryagencies.Serve as the Office of Record for documentation involving theInstitutional Biosafety Committee.Provide all necessary documentation, forms, regulatory guidelines andregulations, etc. for Principal Investigators.Institutional Animal Care and Use Committee (IACUC)1.2.3.4.5.4.5Provide initial and annual retraining on biosafety level criteria, biosafetypractices, and biohazardous waste.Conduct annual laboratory inspections to ensure compliance withappropriate regulations and biosafety guidelines.Provide appropriate animal care that meets or exceeds federal, state, andlocal requirements and specifications.Ensure that animal housing systems are designed and utilized in a mannerthat will minimize the potential exposure of other animals or personnel topotentially biohazardous agents.In cooperation with the investigator and the Institutional BiosafetyCommittee, develop and implement specific standard operationalprocedures, in adherence to the ABSL classification of the agent beingused addressing animal care, research procedures, and procedures in caseof accident or equipment failure.Ensure that all animal care personnel are adequately trained and aware ofthe potential risk associated with each agent.Develop emergency plans for handling accidental spills, personnelexposures, unintentional animal exposure, equipment failure, etc.Principal Investigator (PI)1.2.3.4.Ensure compliance with appropriate National Institute of Healthguidelines and allconditions stated in the protocol approved by theInstitutional Biosafety Committee.Submit protocol applications for all activities or modifications of activitiesinvolving biohazardous materials and obtain approval by the InstitutionalBiosafety Committee prior to initiation of the activities or modifications.Ensure that all laboratory staff, including students, are trained in theaccepted procedures in laboratory practices, containment methods,disinfectant and disposal practices, and required actions in the event of anaccidental spill.Develop a Laboratory Safety Plan, including an emergency action plan foraccidents and spills, as an addendum to this manual, when required.University of Notre DameBiosafety ManualMay 2010Page 4
5.6.7.8.4.6Laboratory Worker1.2.3.4.5.6.5.0Ensure proper handling and disposal of all infectious wastes as outlined inthe Infectious Waste Guide (see Appendix C).Request immunizations for laboratory personnel when working withbiological agents for which there is an effective vaccine available.Maintain all biosafety equipment in appropriate operating condition.Decontaminate laboratory equipment prior to maintenance or disposal.Maintain records of microorganisms and toxins used in the laboratory andbiosafety cabinets.Conduct no activities under the research protocol until the protocol isapproved by the IBC and appropriate training is completed.Follow all procedures and containment methods established for activitiesconducted.Properly utilize all laboratory protective equipment including properclothing, personal protective equipment, and containment devices.Report all accidents and spills to the Principal Investigator or RM&S assoon as possible.Report unsafe conditions to the Principal Investigator, RM&S, or theInstitutional Biosafety Committee.Notify RM&S of any biological sample needing to be shipped (whether inthe United States or internationally) at least 48 business hours prior to thedesired shipping date.REGULATORY COMPLIANCERecombinant DNA activities - The NIH Guidelines for Research Involving RecombinantDNA Molecules governs all rDNA activities including those exempt by the guidelines.Non-rDNA activities involving microorganism and exempt rDNA microorganism - Activitiesinvolving these agents are not federally regulated but it is the position of the IBC and RM&S thatthe procedures and containment levels outlined in CDC publication Biosafety in Microbiologicaland Biomedical Laboratories (BMBL) will govern such activities at the University.Biological Toxins - These agents are not governed by NIH or CDC regulations or guidelines.Although Material Safety Data Sheets (MSDS) are available for most of these agents, specificexposure levels, to our knowledge, have not been established. RM&S will work with the PI tointerpret the MSDS and to establish work and disposal procedures which will protect the users ofthe materials and the environment outside the laboratory.Blood and Other Body Fluids - OSHA's standard on bloodborne pathogens will govern anyactivity involving human blood or other potentially infected body fluids. Compliance withthis standard is administered by RM&S. Information on the university's blood-borne pathogenprogram can be found in the Blood-Borne Pathogens Policy.University of Notre DameBiosafety ManualMay 2010Page 5
Tuberculosis - OSHA has published guidelines for activities which potentially expose peopleto tuberculosis pending publication of an OSHA Standard regulating such exposures in theclinical setting. Compliance with the current guideline and the future standard is administered byRM&S. Research activities involving Mycobacterium tuberculosis will be governed accordinglyby NIH or CDC guidelines. Should the OSHA standard apply to the research environment in thefuture, those requirements will be made available to the PI's.Chemicals - Chemical usage in educational and research laboratories are governed by OSHAStandard 1910.1450, Occupational Exposures to Hazardous Chemicals in Laboratories, and isadministered by RM&S.Radioactive Materials and Radiation-Producing Devices - Regulated by the Nuclear RegulatoryCommission and the Indiana State Department of Health-Radiological Health Section. Theradiation safety program is administered by the Radiation Control Committee and enforced bythe Radiation Safety Officer. The Radiation Safety Manual contains university procedures forusing radioactive materials and radiation-producing devices.6.0SUMMARY OF BIOSAFETY LEVELSAssignment of Biosafety Levels (BL) - It is the responsibility of the PI to initially assign the BLto his/her protocol. This level may be changed either upward or downward during review by theIBC. All parties involved in assigning BLs will follow the standard levels of 1, 2 or 3 as outlinedin either NIH’s Guidelines for Research Involving Recombinant DNA Molecules or CDC’sBiosafety in Microbiological and Biomedical Laboratories. The BLs correspond directly to theclass of organism to be used in a protocol. The classes are defined as follows:Class 1Class 2Organisms not known to cause disease in healthy adults.Associated with human disease, infection transmitted through autoinoculation,ingestion, and mucous membrane exposure.Indigenous or exotic agents with potential for aerosol transmission; disease mayhave serious or lethal consequences.Dangerous/exotic agents which pose high risk of life-threatening disease, aerosoltransmitted lab infections; or related agents with unknown risk of transmission.Class 3Class 47.0PROTOCOL SUBMISSION AND REVIEWMandatory Submission of Protocol Application - PI's proposing research/academic activitiesinvolving microorganisms (including exempt and non-exempt rDNA activities) and biologicaltoxins must complete the university's Biosafety Protocol Application form and submit it toOffice of Research, for review and approval action prior to initiation of the activity.Voluntary Submission of Protocol Application - Researchers working with blood or otherpotentially infectious body fluids, carcinogens, mutagens or teratogens in the absence ofmicroorganisms are requested to complete the university's Biosafety Protocol Application formand forward to IBC/RM&S to assistant in the administration of the OSHA programs governingUniversity of Notre DameBiosafety ManualMay 2010Page 6
occupational exposures to these agents. The review of these protocol applications will beundertaken by IBC in cooperation with RM&S. There will be no assignment of a biosafety levelfor these protocols.7.1Protocol Review and Approval1.rDNA Activities - All protocols involving rDNA activities must follow therequirement of the National Institutes of Health as presented in the latestedition of theNIH Guidelines for Research Involving Recombinant DNAMolecules and all supplements published thereafter in the FederalRegister. In the case of gene therapy protocols, transferring drug resistenceto organisms not known to acquire the trait naturally, and the cloning ofhighly potent toxins, it is the responsibility of the PI and the IBC to ensurereview by the NIH as required under current government guidelines. Nonexempt BL 1 and 2 and exempt rDNA protocols not requiring review byfederal agencies can be approved by the IBC. Areas to address whenrDNA protocols are being prepared for submittal to OR are:a.rDNA Insert(1)Synthetic and associated sequence(s)(2)Potential protein productb.Vector(1)Carrier used to introduce rDNA into the host system thatfacilitates replication(2)Plasmids, organelles, virusesc.Host(1)Organism in which the rDNA replicates(2)Bacteria, yeast, plant, animal cellsd.Containment - Several containment methods are described below:(1)Biological Containment:(a)Limit infectivity of vector or vehicle for specifichosts(b)Limit dissemination and survivability of host and/orvector in the environment(2)Physical Containment:(a)Specifically designed equipment and facilities usedto physically contain microbes(a)Limit access to facilitiese.Good Laboratory Practices:(a)Specifically designed practices and procedures usedto physically contain microbes(b)Mechanisms for inactivation and disposal ofmicrobesUniversity of Notre DameBiosafety ManualMay 2010Page 7
2.8.0Non-rDNA Protocols Involving Microorganisms or Toxins - IBC approvalis required for all protocols involving microorganisms. Protocolsinvolving biological toxins in the absence of microorganisms will be underthe review authority of the IBC, but will not be assigned a biosafety level.TRAINING8.1.All IBC members, PI's, and laboratory staff members conducting activitiesinvolving microorganisms or biotoxins, are required to receive training inbiosafety, regardless of the level of activity they propose to use (BL1, BL2, orBL3). This commitment can be met by attending the training sessions given bythe IBC and/or RM&S or viewing the video training film approved by the IBC.Record of attendance will be maintained by RM&S. Additionally, the PI isresponsible for the development and administering of training to their Laboratorystaff members and students.This training shall address biosafety and laboratory safety relative to the activitieson-going in the laboratory. Training should include, but not necessarily be limitedto, procedures and techniques, laboratory safety rules, emergency response, spillcontainment and cleanup, and instructions on the operating parameters andprocedures for use of laboratory equipment (chemical fume hood, biosafetycabinets, autoclaves, centrifuge, etc.). Some equipment, when used improperly,can give less than desired results and may even result in accidents withsevere injury to the user.PIs must provide training to lab personnel regarding lab specific SOPs. Recordsof training must be maintained by PI and a copy sent to RM&S.8.2.Training must be given to all new laboratory employees or students and allmembers of the laboratory staff should receive annual refresher training providedby Risk Management. Record of attendance and the training provided should bemaintained by the RM&S. Records are to be kept for a minimum of three (3)years. Biosafety references are available through RM&S which can assist the PIin meeting training requirements. PI's will also ensure that everyone involved intheir laboratory operations also participate in other training requirements relativeto health and safety as administered by RM&S. Examples of this training wou
Biosafety Manual May 2010 Page 2 Class I Biosafety Cabinet - An enclosure with an inward airflow through the front opening. Provides protection for the worker and the laboratory environment but not to product being utilized in the cabinet. Class II Biosafety Cabinet An enclosure with an inward airflow through the front opening.
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