Table N-1



Biosafety Standards Comparison

LBNL, May 2008

This reference document was complied by Lawrence Berkeley National Laboratory (LBNL) as a resource to compare select biosafety requirements and guidelines by topic from the following biosafety standards:

• Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control (CDC) and National Institutes of Health (NIH), fourth (1999) and fifth (2007) editions

• Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), National Institutes of Health (NIH), Effective January 2002, Federal Register, November 19, 2001 (66FR57970)

• Laboratory Biosafety Manual, World Health Organization (WHO), Geneva, third edition (2004)

• 29 CFR 1910.1030, Bloodborne Pathogens, OSHA (as of 2008)

Topics are generally organized according to standard and special Biosafety Level 1 (BL1) and Biosafety Level 2 (BL2) laboratory practices, safety equipment, personal protective equipment, and facilities as outlined in the BMBL and NIH Guidelines.

Consult the LBNL Biosafety Manual for biosafety requirements at LBNL. This document is only a resource.

Laboratory Biosafety Level 1

|Topic |BMBL 4th Edition |BMBL 5th Edition |NIH Guidelines 2002 |WHO Laboratory Biosafety Manual 3rd |

| |1999 |2007 | |Ed |

|A. BL1 Standard Microbiological Practices | | |

|Access Control |Access to the laboratory is limited |The laboratory supervisor must enforce |Access to the |Only authorized persons should be |

| |or restricted at the discretion of |the institutional policies that control|laboratory is limited |allowed to enter the laboratory |

| |the laboratory director when |access to the laboratory. |or restricted at the |working areas. Children should not be|

| |experiments or work with cultures and| |discretion of the |authorized or allowed to enter |

| |specimens are in progress. | |Principal Investigator |laboratory working areas. Laboratory |

| | | |when experiments are in|doors should be kept closed. |

| | | |progress. | |

|Decontamination|All cultures, stocks, and other |Decontaminate all cultures, stocks, and|Work surfaces are |Contaminated liquids must be |

| |regulated wastes are decontaminated |other potentially infectious materials |decontaminated once a |decontaminated (chemically or |

| |before disposal by an approved |before disposal using an effective |day and after any spill|physically) before discharge to the |

| |decontamination method such as |method. |of viable material. |sanitary sewer. An effluent treatment|

| |autoclaving. | |All contaminated liquid|system may be required, depending on |

| | | |or solid wastes are |the risk assessment for the agent(s) |

| |Work surfaces are decontaminated at | |decontaminated before |being handled. |

| |least once a day and after any sp ill| |disposal. | |

| |of viable material. | | | |

|Eating, |Eating, drinking, smoking, handling |Eating, drinking, smoking, handling |Eating, drinking, |Eating, drinking, smoking, applying |

|drinking, |contact lenses, |contact lenses, applying cosmetics must|smoking, and applying |cosmetics and handling contact lenses|

|smoking, |applying cosmetics are not permitted |not be permitted in the laboratory. |cosmetics are not |is prohibited in the laboratory |

|handling of |in the work areas | |permitted in the work |working areas. |

|contact lenses,| | |area. | |

|applying | | | | |

|cosmetics. | | | | |

|Food Storage |Storing food for human use is not |Storing food for human consumption must|Food may be stored in |Storing human foods or drinks |

| |permitted in the work areas. |not be permitted in laboratory areas. |cabinets or |anywhere in the laboratory working |

| | |Food must be stored outside the |refrigerators |areas is prohibited. |

| |Food is stored outside the work area |laboratory area in cabinets or |designated and used for| |

| |in cabinets or refrigerators |refrigerators designated and used for |this purpose only. | |

| |designated and used for this purpose |this purpose. | | |

| |only. | | | |

|Hand-washing |Persons wash their hands after they |Hand washing protocols must be |Persons wash their |Personnel must wash their hands after|

| |handle viable materials, after |rigorously followed. |hands: (i) after they |handling infectious materials and |

| |removing gloves, and before leaving | |handle materials |animals, and before they leave the |

| |the laboratory. |Persons must wash their hands after |involving organisms |laboratory working areas. |

| | |working with potentially hazardous |containing recombinant | |

| | |materials and before leaving the |DNA molecules and | |

| | |laboratory. |animals, and (ii) | |

| | | |before exiting the | |

| | | |laboratory. | |

|Hygiene | | |In the interest of good| |

| | | |personal hygiene, | |

| | | |facilities (e.g., hand | |

| | | |washing sink, shower, | |

| | | |changing room) and | |

| | | |protective clothing | |

| | | |(e.g., uniforms, lab | |

| | | |coats) shall be | |

| | | |provided that are | |

| | | |appropriate for the | |

| | | |risk of exposure to | |

| | | |viable organisms | |

| | | |containing recombinant | |

| | | |DNA molecules. | |

|Insect & Rodent|An insect and rodent control program |An effective integrated pest management|See Special Practices |None |

|Control |is in effect. |program is required | | |

|Mouth Pipeting |Mouth pipetting is prohibited; |Mouth pipetting is prohibited; |Mechanical pipetting |Pipetting by mouth must be strictly |

| |mechanical pipetting devices are |mechanical pipetting devices must be |devices are used; mouth|forbidden. |

| |used. |used. |pipetting is | |

| | | |prohibited. | |

|Sharps |Policies for the safe handling of |Policies for the safe handling of | |The use of hypodermic needles and |

| |sharps are instituted. |sharps, such as needles, scalpels, | |syringes should be limited. They must|

| | |pipettes, and broken glassware must be | |not be used as substitutes for |

| | |developed and implemented. Whenever | |pipetting devices or for any purpose |

| | |practical, laboratory supervisors | |other than parenteral injection or |

| | |should adopt improved engineering and | |aspiration of fluids from laboratory |

| | |work practice controls that reduce risk| |animals. |

| | |of sharps injuries. | | |

|Sharps | |Precautions, including those listed | | |

| | |below, must always be taken with sharp | | |

| | |items. These include: | | |

| | |a. Careful management of needles and | | |

| | |other sharps are of primary importance.| | |

| | |Needles must not be bent, sheared, | | |

| | |broken, recapped, removed from | | |

| | |disposable syringes, or otherwise | | |

| | |manipulated by hand before disposal. | | |

| | |b. Used disposable needles and syringes| | |

| | |must be carefully placed in | | |

| | |conveniently located puncture-resistant| | |

| | |containers used for sharps disposal. | | |

| | |c. Non disposable sharps must be placed| | |

| | |in a hard walled container for | | |

| | |transport to a processing area for | | |

| | |decontamination, preferably by | | |

| | |autoclaving. | | |

| | |d. Broken glassware must not be handled| | |

| | |directly. Instead, it must be removed | | |

| | |using a brush and dustpan, tongs, or | | |

| | |forceps. Plasticware should be | | |

| | |substituted for glassware whenever | | |

| | |possible. | | |

|Shoes |None |None |None |Open-toed footwear must not be worn |

| | | | |in laboratories. |

|Splashes and |All procedures are performed |Perform all procedures to minimize the |All procedures are |All technical procedures should be |

|Aerosols |carefully to minimize the creation of|creation of splashes and/or aerosols. |performed carefully to |performed in a way that minimizes the|

| |splashes or aerosols. | |minimize the creation |formation of aerosols and droplets. |

| | | |of aerosols | |

|Signs |A biohazard sign may be posted at the|A sign incorporating the universal |None |None |

| |entrance to the laboratory whenever |biohazard symbol must be posted at the | | |

| |infectious agents are present. The |entrance to the laboratory when | | |

| |sign may include the name of the |infectious agents are present. The sign| | |

| |agent(s) in use and the name an d |may include the name of the agent(s) in| | |

| |phone number of the investigator. |use, and the name and phone number of | | |

| | |the laboratory supervisor or other | | |

| | |responsible personnel. Agent | | |

| | |information should be posted in | | |

| | |accordance with the institutional | | |

| | |policy. | | |

|Spills |None |None |None- |All spills, accidents and overt or |

| | | | |potential exposures to infectious |

| | | | |materials must be reported to the |

| | | | |laboratory supervisor. A written |

| | | | |record of such accidents and |

| | | | |incidents should be maintained. |

|Training |None |The laboratory supervisor must ensure |None |Continuous in-service training in |

| | |that laboratory personnel receive | |safety measures is essential. |

| | |appropriate training regarding their | | |

| | |duties, the necessary precautions to | | |

| | |prevent exposures, and exposure | | |

| | |evaluation procedures. Personnel must | | |

| | |receive annual updates or additional | | |

| | |training when procedural or policy | | |

| | |changes occur. | | |

|Work Surfaces |Work surfaces are decontaminated at |Decontaminate work surfaces after |Work surfaces are |Work surfaces must be decontaminated |

| |least once a day and after any spill |completion of work and after any spill |decontaminated once a |after any spill of potentially |

| |of viable material. |or splash of potentially infectious |day and after any spill|dangerous material and at the end of |

| | |material with appropriate disinfectant.|of viable material. |the working day. |

|Transport of |Materials to be decontaminated |Materials to be removed from the |See Special Practices |To avoid accidental leakage or |

|contamin-ated |outside of the immediate laboratory |facility for decontamination must be |below |spillage, secondary containers, such |

|materials |are packaged in accordance with |packed in accordance with applicable | |as boxes, should be used, fitted with|

| |applicable local, state, and federal |local, state, and federal regulations. | |racks so that the specimen containers|

| |regulations before removal from the |Depending on where the decontamination | |remain upright. The secondary |

| |facility. |will be performed, the following | |containers may be of metal or |

| | |methods should be used prior to | |plastic, should be auto-clavable or |

| |Materials to be decontaminated |transport: Materials to be | |resistant to the action of chemical |

| |outside of the immediate laboratory |decontaminated outside of the immediate| |disinfectants, and the seal should |

| |are to be placed in a durable, |laboratory must be placed in a durable,| |preferably have a gasket. They should|

| |leak-proof container and closed for |leak proof container and secured for | |be regularly decontaminated. |

| |transport from the laboratory. |transport. | | |

| | | | |Packing and transportation must |

| | | | |follow applicable national and/or |

| | | | |international regulations. |

|B. BL1 Special Practices | | | |

| |None |None |Contaminated materials |None |

| | | |that are to be | |

| | | |decontaminated at a | |

| | | |site away from the | |

| | | |laboratory are placed | |

| | | |in a durable leak-proof| |

| | | |container which is | |

| | | |closed before being | |

| | | |removed from the lab. | |

| | | | | |

| | | |An insect and rodent | |

| | | |control program is in | |

| | | |effect. | |

|C. BL1 Safety Equipment (Primary Barriers and PPE) | | |

|Biosafety |Special containment devices or |Special containment devices or |Special containment |None |

|Cabinets |equipment such as biological safety |equipment, such as BSCs, are not |equipment is generally | |

| |cabinets are generally not required |generally required. |not required for | |

| |for manipulations of agents assigned | |manipulations of agents| |

| |to BSL 1. | | | |

|Lab Coats, |It is recommended that lab coats, |Protective laboratory coats, gowns, or |None |Laboratory coveralls, gowns or |

|Gowns, or |gowns, or uniforms be worn to prevent|uniforms are recommended to prevent | |uniforms must be worn at all times |

|Uniforms. |contamination or soiling of street |contamination of personal clothing. | |for work in the laboratory. |

| |clothes. | | | |

|Eye wash |None |None |None |Safety systems should cover fire, |

| | | | |electrical emergencies, emergency |

| | | | |shower and eyewash facilities. |

|Eye Wear |Persons who wear contact lenses in |Wear protective eyewear when conducting|None |Safety glasses, face shields (visors)|

| |laboratories should also wear goggles|procedures that have the potential to | |or other protective devices must be |

| |or a face shield. |create splashes of microorganisms or | |worn when it is necessary to protect |

| | |other hazardous materials. Persons who | |the eyes and face from splashes, |

| | |wear contact lenses in laboratories | |impacting objects and sources of |

| | |should also wear eye protection. | |artificial ultraviolet radiation |

|Protective |Protective eyewear should be worn for|Protective laboratory coats, gowns, or |None |.None |

|Laboratory |conduct of procedures in which |uniforms are recommended to prevent | | |

|Coats, Gowns, |splashes of micro-organisms or other |contamination of personal clothing. | | |

|or uniforms. |hazardous materials is anticipated. | | | |

|Gloves |Gloves should be worn if the skin on |Gloves must be worn to protect hands |None |Appropriate gloves must be worn for |

| |the hands is broken or if a rash is |from exposure to hazardous materials. | |all procedures that may involve |

| |present. Alternatives to powdered |Glove selection should be based on an | |direct or accidental contact with |

| |latex gloves should be available. |appropriate risk assessment. | |blood, body fluids and other |

| | |Alternatives to latex gloves should be | |potentially infectious materials or |

| | |available. Wash hands prior to leaving | |infected animals. After use, gloves |

| | |the laboratory. In addition, BSL-1 | |should be removed aseptically and |

| | |workers should: | |hands must then be washed. |

| | |Change gloves when contaminated, | | |

| | |integrity has been compromised, or when| | |

| | |otherwise necessary. | | |

| | |b. Remove gloves and wash hands when | | |

| | |work with hazardous materials has been | | |

| | |completed and before leaving the | | |

| | |laboratory. | | |

| | |Do not wash or reuse disposable gloves.| | |

| | |Dispose of used gloves with other | | |

| | |contaminated laboratory waste. | | |

| | | |

|Backflow |None |None |None |A dependable supply of good quality |

| | | | |water is essential. There should be |

| | | | |no cross-connections between sources |

| | | | |of laboratory and drinking-water |

| | | | |supplies. An anti-backflow device |

| | | | |should be fitted to protect the |

| | | | |public water system. |

|Bench Tops |Bench tops are impervious to water |Bench tops must be impervious to water |Bench tops are |Bench tops should be impervious to |

| |and are resistant to moderate heat |and resistant to heat, organic |impervious to water and|water and resistant to disinfectants,|

| |and the organic solvents, acids, |solvents, acids, alkalis, and other |resistant to acids, |acids, alkalis, organic solvents and |

| |alkalis, and chemicals used to |chemicals. |alkalis, organic |moderate heat. |

| |decontaminate the work surface and | |solvents, and moderate | |

| |equipment. | |heat. | |

|Carpets and |Carpets and rugs in laboratories are |Carpets and rugs in laboratories are |None |None |

|Rugs |not appropriate. |not appropriate. | | |

|Cleanliness |The laboratory is designed so that it|The laboratory should be designed so |The laboratory is |The laboratory should be kept neat, |

| |can be easily cleaned. |that it can be easily cleaned. Spaces |designed so that it can|clean and free of materials that are |

| | |between benches, cabinets, and |be easily cleaned. |not pertinent to the work. Open |

| | |equipment should be accessible for | |spaces between and under benches, |

| | |cleaning | |cabinets and equipment should be |

| | | | |accessible for cleaning. |

|Chairs |None |Chairs used in laboratory work must be |None |Constructed of materials that are |

| | |covered with a non-porous material that| |impermeable to liquids, resistant to |

| | |can be easily cleaned and | |corrosion and meet structural |

| | |decontaminated with appropriate | |requirements |

| | |disinfectant. | | |

|Doors |Laboratories should have doors for |Laboratories should have doors for |None |Doors should have vision panels, |

| |access control. |access control. | |appropriate fire ratings, and |

| | | | |preferably be self-closing. |

|Eating |None |None |None |Facilities for eating and drinking |

| | | | |and for rest should be provided |

| | | | |outside the laboratory working areas.|

|Electrical |None |None |None |There should be a reliable and |

| | | | |adequate electricity supply and |

| | | | |emergency lighting to permit safe |

| | | | |exit. A stand-by generator is |

| | | | |desirable for the support of |

| | | | |essential equipment, such as |

| | | | |incubators, biological safety |

| | | | |cabinets, freezers, etc., and for the|

| | | | |ventilation of animal cages. |

|Gas |None |None |None |There should be a reliable and |

| | | | |adequate supply of gas. Good |

| | | | |maintenance of the installation is |

| | | | |mandatory. |

|Laboratory |Laboratory furniture is capable of |Laboratory furniture must be capable of|Laboratory furniture is|Laboratory furniture should be |

|Furniture |supporting anticipated loading and |supporting anticipated loads and uses. |sturdy. |sturdy. |

| |uses. | | | |

|Lighting |None |None |None |Illumination should be adequate for |

| | | | |all activities. Undesirable |

| | | | |reflections and glare should be |

| | | | |avoided. |

|Security |None |None |None |Laboratories and animal houses are |

| | | | |occasionally the targets of vandals. |

| | | | |Physical and fire security must be |

| | | | |considered. Strong doors, screened |

| | | | |windows and restricted issue of keys |

| | | | |are compulsory. Other measures should|

| | | | |be considered and applied, as |

| | | | |appropriate, to augment security |

|Sink |Each laboratory contains a sink for |Laboratories must have a sink for hand |Each laboratory |Hand-washing basins, with running |

| |hand-washing. |washing. |contains a sink for |water if possible, should be provided|

| | | |hand washing. |in each laboratory room, preferably |

| | | | |near the exit door. |

|Spaces |Spaces between benches, cabinets, and|None |Spaces between benches,|Storage space must be adequate to |

| |equipment are accessible for | |cabinets, and equipment|hold supplies for immediate use and |

| |cleaning. | |are accessible for |thus prevent clutter on bench tops |

| | | |cleaning. |and in aisles. Additional long-term |

| | | | |storage space, conveniently located |

| | | | |outside the laboratory working areas,|

| | | | |should also be provided. |

|Storage |None |None |None |Space and facilities should be |

| | | | |provided for the safe handling and |

| | | | |storage of solvents, radioactive |

| | | | |materials, and compressed and |

| | | | |liquefied gases |

|Ventilation |None |None |None |In the planning of new facilities, |

| | | | |consideration should be given to the |

| | | | |provision of mechanical ventilation |

| | | | |systems that provide an inward flow |

| | | | |of air without re-circulation. |

|Windows |If the laboratory has windows that |Laboratories windows that open to the |If the laboratory has |When windows can be opened, they |

| |open to the exterior, they are fitted|exterior should be fitted with screens.|windows that open, they|should be fitted with arthropod-proof|

| |with fly screens. | |are fitted with fly |screens. |

| | | |screens. | |

|Walls |None |None |None |Walls, ceilings and floors should be |

| | | | |smooth, easy to clean, impermeable to|

| | | | |liquids and resistant to the |

| | | | |chemicals and disinfectants normally |

| | | | |used in the laboratory. Floors should|

| | | | |be slip-resistant. |

Laboratory Biosafety Level 2

|Topic |CDC BMBL 4th Edition 1999 |CDC BMBL 5th Edition 2007 |NIH Guidelines 2002 |

|Access Control |Access to the laboratory is limited or |The laboratory supervisor must enforce |Access to the laboratory |HIV and HBV Research Laboratories and |Only authorized persons |

| |restricted at the discretion of the |the institutional policies that control|is limited or restricted |Production Facilities: |should be allowed to enter |

| |laboratory director when experiments |access to the laboratory. |by the Principal |Laboratory doors shall be kept closed when |the laboratory working areas.|

| |are in progress. | |Investigator when work |work involving HIV or HBV is in progress. |Laboratory doors should be |

| | | |with organisms containing |Access to the work area shall be limited to |kept closed. |

| |The laboratory director has the final | |recombinant DNA molecules |authorized persons. |Children should not be |

| |responsibility for assessing each | |is in progress. | |authorized or allowed to |

| |circumstance and determining who may | | | |enter laboratory working |

| |enter or work in the laboratory or | |The Principal Investigator| |areas. |

| |animal room. | |limits access to the | | |

| | | |laboratory. The Principal | |Access to animal houses |

| | | |Investigator has the final| |should be specially |

| | | |responsibility for | |authorized. |

| | | |assessing each | | |

| | | |circumstance and | | |

| | | |determining who may enter | | |

| | | |or work in the laboratory.| | |

|Decontamination |All cultures, stocks, and other |Decontaminate all cultures, stocks, and|Work surfaces are |HIV and HBV Research Laboratories and |Contaminated liquids must be |

| |regulated wastes are decontaminated |other potentially infectious materials |decontaminated at least |Production Facilities: |decontaminated (chemically or|

| |before disposal by an approved |before disposal using an effective |once a day and after any |Before disposal all waste from work areas and|physically) before discharge |

| |decontamination method such as |method. Depending on where the |spill of viable material. |from animal rooms shall either be incinerated|to the sanitary sewer. An |

| |autoclaving. |decontamination will be performed, the |All contaminated liquid or|or decontaminated by a method such as |effluent treatment system may|

| | |following methods should be used prior |solid wastes are |autoclaving known to effectively destroy |be required, depending on the|

| |Work surfaces are decontaminated on |to transport: Decontaminate work |decontaminated before |bloodborne pathogens. |risk assessment for the |

| |completion of work or at the end of the|surfaces after completion of work and |disposal. | |agent(s) being handled. |

| |day and after any spill or splash of |after any spill or splash of | | | |

| |viable material with disinfectants that|potentially infectious material with | | |Written documents that are |

| |are effective against the agents of |appropriate disinfectant. | | |expected to be removed from |

| |concern. | | | |the laboratory need to be |

| | |Laboratory equipment should be | | |protected from contamination |

| | |routinely decontaminated, as well as, | | |while in the laboratory. |

| | |after spills, splashes, or other | | | |

| | |potential contamination. | | | |

| | | | | | |

| | |Decontaminate work surfaces after | | | |

| | |completion of work and after any spill | | | |

| | |or splash of potentially infectious | | | |

| | |material with appropriate disinfectant.| | | |

|Disposal |None |Eye and face protection must be |None |Disposal of all regulated waste shall be in |All contaminated materials, |

| | |disposed of with other contaminated | |accordance with applicable regulations of the|specimens and cultures must |

| | |laboratory waste or decontaminated | |United States, States and Territories, and |be decontaminated before |

| | |before reuse. Persons who wear contact | |political subdivisions of States and |disposal or cleaning for |

| | |lenses in laboratories should also wear| |Territories. |reuse. |

| | |eye protection. | | | |

| | | | |Regulated waste shall be placed in containers|Waste is anything that is to |

| | | | |which are: Closable; |be discarded. In |

| | | | |Constructed to contain all contents and |laboratories,decontamination |

| | | | |prevent leakage of fluids during handling, |of wastes and their ultimate |

| | | | |storage, transport or shipping; |disposal are closely |

| | | | |Labeled or color-coded in accordance with |interrelated. In terms of |

| | | | |paragraph (g)(1)(i) this standard; and closed|daily use, few if any |

| | | | |prior to removal to prevent spillage or |contaminated materials will |

| | | | |protrusion of contents during handling, |require actual removal from |

| | | | |storage, transport, or shipping. |the laboratory or |

| | | | | |destruction. Most glassware, |

| | | | |All personal protective equipment shall be |instruments and laboratory |

| | | | |removed prior to leaving the work area. When |clothing will be reused or |

| | | | |personal protective equipment is removed it |recycled. The overriding |

| | | | |shall be placed in an appropriately |principle is that all |

| | | | |designated area or container for storage, |infectious materials should |

| | | | |washing, decontamination or disposal. |be decontaminated, autoclaved|

| | | | | |or incinerated within the lab|

| | | | |Regulated waste that has been decontaminated | |

| | | | |need not be labeled or color-coded. | |

|Eating, drinking, |Eating, drinking, smoking, handling |Eating, drinking, smoking, handling |Eating, drinking, smoking,|Eating, drinking, smoking, applying cosmetics|Eating, drinking, smoking, |

|smoking, handling of |contact lenses, and applying cosmetics |contact lenses, applying cosmetics must|and applying cosmetics are|or lip balm, and handling contact lenses are |applying cosmetics and |

|contact lenses, |are not permitted in the work areas. |not be permitted in laboratory areas. |not permitted in the work |prohibited in work areas where there is a |handling contact lenses is |

|applying cosmetics | | |area. |reasonable likelihood of occupational |prohibited in the laboratory |

| | | | |exposure. |working areas. |

|Food Storage |Food is stored outside the work area in|Storing food for human consumption must|Food may be stored in |Food and drink shall not be kept in |Storing human foods or drinks|

| |cabinets or refrigerators designated |not be permitted in laboratory areas. |cabinets or refrigerators |refrigerators, freezers, shelves, cabinets or|anywhere in the laboratory |

| |for this purpose only. | |designated and used for |on countertops or benchtops where blood or |working areas is prohibited. |

| | |Food must be stored outside the |this purpose only. |other potentially infectious materials are | |

| | |laboratory area in cabinets or | |present. | |

| | |refrigerators designated and used for | | | |

| | |this purpose. | | | |

|Handwashing |Persons wash their hands after they |Persons must wash their hands after |Persons wash their hands: |When provision of handwashing facilities is |Personnel must wash their |

| |handle viable materials, after removing|working with potentially hazardous |(i) after handling |not feasible, the employer shall provide |hands after handling |

| |gloves, and before leaving the |materials and before leaving the |materials involving |either an appropriate antiseptic hand |infectious materials and |

| |laboratory. |laboratory. |organisms containing |cleanser in conjunction with clean |animals, and before they |

| | | |recombinant DNA molecules |cloth/paper towels or antiseptic towelettes. |leave the laboratory working |

| | | |and animals, and (ii) when|When antiseptic hand cleansers or towelettes |areas. |

| | | |exiting the laboratory. |are used, hands shall be washed with soap and| |

| | | | |running water as soon as feasible. |After use, gloves should be |

| | | | | |removed aseptically and hands|

| | | | |Employers shall ensure that employees wash |must then be washed. |

| | | | |their hands immediately or as soon as | |

| | | | |feasible after removal of gloves or other | |

| | | | |personal protective equipment. | |

|Insect & Rodent |An insect and rodent control program is|An effective integrated pest management|An insect and rodent | |There should be an arthropod |

|Control |in effect. |program is required. |control program is in | |and rodent control programme.|

| | | |effect. | | |

|Mouth Pipetting |Mouth pipetting is prohibited; |Mouth pipetting is prohibited; |Mechanical pipetting |Mouth pipetting/ suctioning of blood or other|Pipetting by mouth must be |

| |mechanical pipetting devices are used. |mechanical pipetting devices must be |devices are used; mouth |potentially infectious materials is |strictly forbidden. |

| | |used. |pipetting is prohibited. |prohibited. |Pipetting aids – to avoid |

| | | | | |mouth pipetting. Many |

| | | | | |different designs are |

| | | | | |available. |

| | | | | |Materials must not be placed |

| | | | | |in the mouth. Labels must not|

| | | | | |be licked. |

|Sharps |Policies for the safe handling of |Policies for the safe handling of |Hypodermic needles and |Contaminated needles and other contaminated |The use of hypodermic needles|

| |sharps are instituted. Plasticware |sharps, such as needles, scalpels, |syringes are used only for|sharps shall not be bent, recapped, or |and syringes should be |

| |should be substituted for glassware |pipettes, and broken glassware must be |parenteral injection and |removed except as noted in paragraphs |limited. They must not be |

| |whenever possible. |developed and implemented. Whenever |aspiration of fluids from |(d)(2)(vii)(A) and (d)(2)(vii)(B) below. |used as substitutes for |

| | |practical, laboratory supervisors |laboratory animals and |Shearing or breaking of contaminated needles |pipetting devices or for any |

| | |should adopt improved engineering and |diaphragm bottles. |is prohibited. |purpose other than parenteral|

| | |work practice controls that reduce risk| | |injection or aspiration of |

| | |of sharps injuries. | | |fluids from laboratory |

| | | | | |animals. |

|Sharps |Syringes which re-sheathe the needle, |Careful management of needles and other|Only needle-locking |Contaminated needles and other contaminated |After use, hypodermic needles|

| |needleless systems, and other safety |sharps are of primary importance. |syringes or disposable |sharps shall not be bent, recapped or removed|should not be recapped, |

| |devices are used when appropriate. |Needles must not be bent, sheared, |syringe needle units |unless the employer can demonstrate that no |clipped or removed from |

| | |broken, recapped, removed from |(i.e., needle is integral |alternative is feasible or that such action |disposable syringes. The |

| | |disposable syringes, or otherwise |to the syringe) are used |is required by a specific medical or dental |complete assembly should be |

| | |manipulated by hand before disposal. |for the injection or |procedure. |placed in a sharps disposal |

| | | |aspiration of fluids | |container. Disposable |

| | | |containing organisms that | |syringes, used alone or with |

| | | |contain recombinant DNA | |needles, should be placed in |

| | | |molecules. Extreme caution| |sharps disposal containers |

| | | |should be used when | |and incinerated, with prior |

| | | |handling needles and | |autoclaving if required. |

| | | |syringes to avoid | | |

| | | |auto-inoculation and the | | |

| | | |generation of aerosols | | |

| | | |during use and disposal. | | |

| | | |Needles should not be | | |

| | | |bent, sheared, replaced in| | |

| | | |the needle sheath or | | |

| | | |guard, or removed from the| | |

| | | |syringe following use. The| | |

| | | |needle and syringe should | | |

| | | |be promptly placed in a | | |

| | | |puncture-resistant | | |

| | | |container and | | |

| | | |decontaminated, preferably| | |

| | | |autoclaved, before discard| | |

| | | |or reused. | | |

|Sharps | |Used disposable needles and syringes | |Immediately or as soon as possible after use,|Sharps disposal containers |

| | |must be carefully placed in | |contaminated reusable sharps shall be placed |must be |

| | |conveniently located puncture-resistant| |in appropriate containers until properly |puncture-proof/-resistant and|

| | |containers used for sharps disposal. | |reprocessed. These containers shall be: |must not be filled to |

| | | | |Puncture resistant; Labeled or color-coded in|capacity. When they are |

| | | | |accordance with this standard; Leakproof on |three-quarters full they |

| | | | |the sides and bottom. |should be placed in |

| | | | | |“infectious waste” containers|

| | | | |Reusable sharps that are contaminated with |and incinerated, with prior |

| | | | |blood or other potentially infectious |autoclaving if laboratory |

| | | | |materials shall not be stored or processed in|practice requires it. Sharps |

| | | | |a manner that requires employees to reach by |disposal containers must not |

| | | | |hand into the containers where these sharps |be discarded in landfills. |

| | | | |have been placed. | |

|Sharps | |Non-disposable sharps must be placed in| |Such bending, recapping or needle removal | |

| | |a hard walled container for transport | |must be accomplished through the use of a | |

| | |to a processing area for | |mechanical device or a one-handed technique. | |

| | |decontamination, preferably by | | | |

| | |autoclaving. | | | |

|Sharps | |Broken glassware must not be handled |. |HIV and HBV Research Laboratories and | |

| | |directly. Instead, it must be removed | |Production Facilities: | |

| | |using a brush and dustpan, tongs, or | |Hypodermic needles and syringes shall be used| |

| | |forceps. Plasticware should be | |only for parenteral injection and aspiration | |

| | |substituted for glassware whenever | |of fluids from laboratory animals and | |

| | |possible. | |diaphragm bottles. Only needle-locking | |

| | | | |syringes or disposable syringe-needle units | |

| | | | |(i.e., the needle is integral to the syringe)| |

| | | | |shall be used for the injection or aspiration| |

| | | | |of other potentially infectious materials. | |

| | | | |Extreme caution shall be used when handling | |

| | | | |needles and syringes. A needle shall not be | |

| | | | |bent, sheared, replaced in the sheath or | |

| | | | |guard, or removed from the syringe following | |

| | | | |use. The needle and syringe shall be promptly| |

| | | | |placed in a puncture-resistant container and | |

| | | | |autoclaved or decontaminated before reuse or | |

| | | | |disposal. | |

|Shoes |None |None |None |Surgical caps or hoods and/or shoe covers or |Open-toed footwear must not |

| | | | |boots shall be worn in instances when gross |be worn in laboratories. |

| | | | |contamination can reasonably be anticipated | |

| | | | |(e.g., autopsies, orthopaedic surgery). | |

|Signs |A biohazard sign must be posted on the |A sign incorporating the universal |When the organisms |HIV and HBV Research Laboratories and |The international biohazard |

| |entrance to the laboratory when |biohazard symbol must be posted at the |containing recombinant DNA|Production Facilities: When other potentially|warning symbol and sign |

| |etiologic agents are in use. |entrance to the laboratory when |molecules in use in the |infectious materials or infected animals are |(Figure 1) must be displayed |

| |Appropriate information to be posted |infectious agents are present. Posted |laboratory require special|present in the work area or containment |on the doors of the rooms |

| |includes the agent(s) in use, the |information must include: the |provisions for entry |module, a hazard warning sign incorporating |where microorganisms of Risk |

| |biosafety level, the required |laboratory’s biosafety level, the |(e.g., vaccination), a |the universal biohazard symbol shall be |Group 2 or higher risk groups|

| |immunizations, the investigator’s name |supervisor’s name (or other responsible|hazard warning sign |posted on all access doors. The hazard |are handled. |

| |and telephone number, any personal |personnel), telephone number, and |incorporating the |warning sign shall comply with paragraph | |

| |protective equipment that must be worn |required procedures for entering and |universal biosafety symbol|(g)(1)(ii) of this standard. | |

| |in the laboratory, and any procedures |exiting the laboratory. Agent |is posted on the access | | |

| |required for exiting the laboratory. |information should be posted in |door to the laboratory |These signs shall be fluorescent orange-red | |

| | |accordance with the institutional |work area. The hazard |or predominantly so, with lettering and | |

| | |policy. |warning sign identifies |symbols in a contrasting color. | |

| | | |the agent, lists the name | | |

| | | |and telephone number of |The employer shall post signs at the entrance| |

| | | |the Principal Investigator|to work areas which shall bear the following | |

| | | |or other responsible |legend: (Name of the Infectious Agent) | |

| | | |person(s), and indicates |(Special requirements for entering the area) | |

| | | |the special requirement(s)|(Name, telephone number of the laboratory | |

| | | |for entering the |director or other responsible person.) | |

| | | |laboratory. | | |

|Space/Storage |None |None |Experiments of lesser |None |Facilities for storing outer |

| | | |biohazard potential can be| |garments and personal items |

| | | |conducted concurrently in | |should be provided outside |

| | | |carefully demarcated areas| |the laboratory working areas.|

| | | |of the same laboratory. | |Space and facilities should |

| | | | | |be provided for the safe |

| | | | | |handling and storage of |

| | | | | |solvents, radioactive |

| | | | | |materials, and compressed and|

| | | | | |liquefied gases. |

|Splashes and Aerosols |All procedures are performed carefully |Perform all procedures to minimize the |All procedures are |All procedures involving blood or other |All technical procedures |

| |to minimize the creation of splashes or|creation of splashes and/or aerosols. |performed carefully to |potentially infectious materials shall be |should be performed in a way |

| |aerosols. | |minimize the creation of |performed in such a manner as to minimize |that minimizes the formation |

| | | |aerosols |splashing, spraying, spattering, and |of aerosols and droplets. |

| | | | |generation of droplets of these substances. | |

|Training |The laboratory director ensures that |The laboratory supervisor must ensure | |Employers shall ensure that all employees |Staff training should always |

| |laboratory and support personnel |that laboratory personnel receive | |with occupational exposure participate in a |include information on safe |

| |receive appropriate training on the |appropriate training regarding their | |training program which must be provided at no|methods for highly |

| |potential hazards associated with the |duties, the necessary precautions to | |cost to the employee and during working |hazardous procedures that are|

| |work involved, the necessary |prevent exposures, and exposure | |hours. |commonly encountered by all |

| |precautions to prevent exposures, and |evaluation procedures. Personnel must | | |laboratory personnel |

| |the exposure evaluation procedures. |receive annual updates or additional | |Training shall be provided as follows: |and which involve: |

| |Personnel receive annual updates or |training when procedural or policy | |At the time of initial assignment to tasks |1. Inhalation risks (i.e. |

| |additional training as necessary for |changes occur | |where occupational exposure may take place; |aerosol production) when |

| |procedural or policy changes. | | |At least annually thereafter. |using loops, streaking agar |

| | |The laboratory supervisor must ensure | |Employers shall provide additional training |plates, |

| | |that laboratory personnel receive | |when changes such as modification of tasks or|pipetting, making smears, |

| | |appropriate training regarding their | |procedures or institution of new tasks or |opening cultures, taking |

| | |duties, the necessary precautions to | |procedures affect the employee's occupational|blood/serum samples, |

| | |prevent exposures, and exposure | |exposure. The additional training may be |centrifuging, etc. |

| | |evaluation procedures. Personnel must | |limited to addressing the new exposures |2. Ingestion risks when |

| | |receive annual updates or additional | |created. |handling specimens, smears |

| | |training when procedural or policy | | |and cultures |

| | |changes occur. Personal health status | |Material appropriate in content and |3. Risks of percutaneous |

| | |may impact an individual’s | |vocabulary to educational level, literacy, |exposures when using syringes|

| | |susceptibility to infection, ability to| |and language of employees shall be used. |and needles |

| | |receive immunizations or prophylactic | | |4. Bites and scratches when |

| | |interventions. Therefore, all | | |handling animals |

| | |laboratory personnel and particularly | | |5. Handling of blood and |

| | |women of child-bearing age should be | | |other potentially hazardous |

| | |provided with information regarding | | |pathological materials |

| | |immune competence and conditions that | | |6. Decontamination and |

| | |may predispose them to infection. | | |disposal of infectious |

| | |Individuals having these conditions | | |material. |

| | |should be encouraged to self-identify | | | |

| | |to the institution’s healthcare | | | |

| | |provider for appropriate counseling and| | | |

| | |guidance. | | | |

|Training | |The laboratory supervisor must ensure | |HIV and HBV Research Laboratories and |The laboratory supervisor |

| | |that laboratory personnel demonstrate | |Production Facilities: Additional training |(reporting to the laboratory |

| | |proficiency in standard and special | |requirements for employees in HIV and HBV |director) should ensure that |

| | |microbiological practices before | |research laboratories and HIV and HBV |regular training in |

| | |working with BSL-2 agents. | |production facilities are specified in |laboratory safety is |

| | | | |paragraph (g)(2)(ix). |provided. |

|Transportation |Materials to be decontaminated outside |Potentially infectious materials must | |Specimens of blood or other potentially |Packing and transportation |

| |of the immediate laboratory are placed |be placed in a durable, leak proof | |infectious materials shall be placed in a |must follow applicable |

| |in a durable, leak-proof container and |container during collection, handling, | |container which prevents leakage during |national and/or international|

| |closed for transport from the |processing, storage, or transport | |collection, handling, processing, storage, |regulations. |

| |laboratory. |within a facility. | |transport, or shipping. | |

| | | | | | |

| | |Potentially infectious materials must | | | |

| |Materials to be decontaminated off-site|be placed in a durable, leak proof | |HIV and HBV Research Laboratories and | |

| |from the facility are packaged in |container during collection, handling, | |Production Facilities: | |

| |accordance with applicable local, |processing, storage, or transport | |Contaminated materials that are to be | |

| |state, and federal regulations, before |within a facility. | |decontaminated at a site away from the work | |

| |removal from the facility. | | |area shall be placed in a durable, leakproof,| |

| | |Materials to be decontaminated outside | |labeled or color-coded container that is | |

| | |of the immediate laboratory are placed | |closed before being removed from the work | |

| | |in a durable, leak-proof container and | |area. | |

| | |secured for transport from the | | | |

| | |laboratory. | | | |

|Transportation |Cultures, tissues, specimens of body | | |The container for storage, transport, or | |

| |fluids, or potentially | | |shipping shall be labeled or color-coded | |

| |infectious wastes are placed in a | | |according to paragraph (g)(1)(i) and closed | |

| |container with a cover that prevents | | |prior to being stored, transported, or | |

| |leakage during collection, handling, | | |shipped. When a facility utilizes Universal | |

| |processing, storage, transport, or | | |Precautions in the handling of all specimens,| |

| |shipping. | | |the labeling/color-coding of specimens is not| |

| | | | |necessary provided containers are | |

| | | | |recognizable as containing specimens. This | |

| | | | |exemption only applies while such | |

| | | | |specimens/containers remain within the | |

| | | | |facility. Labeling or color-coding in | |

| | | | |accordance with paragraph (g)(1)(i) is | |

| | | | |required when such specimens/ containers | |

| | | | |leave the facility. | |

|Transportation | | | |If outside contamination of the primary | |

| | | | |container occurs, the primary container shall| |

| | | | |be placed within a second container which | |

| | | | |prevents leakage during handling, processing,| |

| | | | |storage, transport, or shipping and is | |

| | | | |labeled or color-coded according to the | |

| | | | |requirements of this standard. | |

|Transportation | | | |If the specimen could puncture the primary | |

| | | | |container, the primary container shall be | |

| | | | |placed within a secondary container which is | |

| | | | |puncture-resistant in addition to the above | |

| | | | |characteristics. | |

|B. BL2 Special Practices | | | |

|Access Control |The laboratory director establishes |The Principal Investigator establishes |The Principal Investigator|Written policies and procedures shall be | |

|(Immunization) |policies and procedures whereby only |policies and procedures whereby only |establishes policies and |established whereby only persons who have | |

| |persons who have been advised of the |persons who have been advised of the |procedures whereby only |been advised of the potential biohazard, who | |

| |potential hazards and meet specific |potential hazard and meet any specific |persons who have been |meet any specific entry requirements, and who| |

| |entry requirements |entry requirements (e.g., immunization)|advised of the potential |comply with all entry and exit procedures | |

| |(e .g., immunization) may enter the |may enter the laboratory or animal |hazard and meet any |shall be allowed to enter the work areas and | |

| |laboratory. |rooms. |specific entry |animal rooms. | |

| | | |requirements (e.g., | | |

| | | |immunization) may enter | | |

| | | |the lab or animal rooms | | |

|Access Warning |In general, persons who are at |All persons entering the laboratory |.None |Universal precautions shall be observed to |Personnel should be advised |

| |increased risk of acquiring infection, |must be advised of the potential | |prevent contact with blood or other |of special hazards, and |

| |or for whom infection may have serious |hazards and meet specific entry/exit | |potentially infectious materials. Under |required to read the safety |

| |consequences, are not allowed in the |requirements. | |circumstances in which differentiation |or operations manual and |

| |laboratory or animal room s. For | | |between body fluid types is difficult or |follow standard practices and|

| |example, persons who are immunocomprom | | |impossible, all body fluids shall be |procedures. The lab |

| |ised or immunosuppressed m ay be at | | |considered potentially infectious materials. |supervisor should make sure |

| |increased risk of acquiring infections.| | | |that all personnel understand|

| | | | |The employer shall ensure that this |these. A copy of the safety |

| | | | |information is conveyed to all affected |or operations manual should |

| | | | |employees, the servicing representative, |be available in the |

| | | | |and/or the manufacturer, as appropriate, |laboratory. |

| | | | |prior to handling, servicing, or shipping so | |

| | | | |that appropriate precautions will be taken.. | |

|Animals |Animals not involved in the work being |Animals and plants not associated with |Animals not involved in | |No animals should be admitted|

| |performed are not permitted in the lab.|the work being performed must not be |the work being performed | |other than those involved in |

| | |permitted in the laboratory. |are not permitted in the | |the work of the laboratory. |

| | | |laboratory. | | |

|Aerosol Generation |Aerosol generation processes may |All procedures involving the |All procedures are |HIV and HBV Research Laboratories and |These may include |

| |include centrifuging, grinding, |manipulation of infectious materials |performed carefully to |Production Facilities: All activities |centrifugation, grinding, |

| |blending, vigorous shaking or mixing, |that may generate an aerosol should be |minimize the creation of |involving other potentially infectious |blending, vigorous shaking or|

| |sonic disruption, opening containers of|conducted within a BSC or other |aerosols. |materials shall be conducted in biological |mixing, sonic disruption, |

| |infectious materials whose internal |physical | |safety cabinets or other physical-containment|opening of containers of |

| |pressures may be different from ambient|containment devices. |Procedures with a high |devices within the containment module. No |infectious materials whose |

| |pressures, inoculating animals | |potential for creating |work with these other potentially infectious |internal pressure may be |

| |intranasally, and harvesting infected |Procedures with a potential for |aerosols are conducted |materials shall be conducted on the open |different from the ambient |

| |tissues |creating infectious aerosols or |(see Appendix G-III-O, |bench. |pressure, intranasal |

| |from animals or embryonate eggs. |splashes are conducted in BSC. These |Footnotes and References | |inoculation of animals, and |

| | |may include pipetting, centrifuging, |of Appendix G). These may | |harvesting of infectious |

| | |grinding, blending, shaking, mixing, |include centrifuging, | |tissues from animals and |

| | |sonicating, opening containers of |grinding, blending, | |eggs. |

| | |infectious |vigorous shaking or | | |

| | |materials, inoculating animals |mixing, sonic disruption, | |Plastic disposable transfer |

| | |intranasally, and harvesting infected |opening containers of | |loops. Alternatively, |

| | |tissues from animals or eggs. |materials whose internal | |electric transfer loop |

| | | |pressures may be different| |incinerators |

| | |High concentrations or large volumes of|from ambient pressures, | |may be used inside the |

| | |infectious agents are used. |intranasal inoculation of | |biological safety cabinet to |

| | | |animals, and harvesting | |reduce aerosol production. |

| | | |infected tissues from | | |

| | | |animals or eggs. | | |

|Biosafety Manual |Biosafety procedures are incorporated |A laboratory-specific biosafety manual |A biosafety manual is |Each employer having an employee(s) with |It is the responsibility of |

| |into standard operating procedures or |must be prepared and adopted as policy.|prepared or adopted. |occupational exposure as defined by paragraph|the laboratory director (the |

| |in a biosafety manual adopted or |The biosafety manual must be available |Personnel are advised of |(b) of this section shall establish a written|person who has immediate |

| |prepared specifically for the |and accessible. |special hazards and are |Exposure Control Plan designed to eliminate |responsibility for the |

| |laboratory by the laboratory director. | |required to read and |or minimize employee exposure. |laboratory) to ensure the |

| |Personnel are advised of special | |follow instructions on | |development and adoption of a|

| |hazards and are required to read and | |practices and procedures. |HIV and HBV Research Laboratories and |biosafety management plan and|

| |follow instructions on practices and | | |Production Facilities: A biosafety manual |a safety or operations |

| |procedures. | | |shall be prepared or adopted and periodically|manual. |

| | | | |reviewed and updated at least annually or | |

| | | | |more often if necessary. Personnel shall be |Each laboratory should adopt |

| | | | |advised of potential hazards, shall be |a safety or operations manual|

| | | | |required to read instructions on practices |that identifies known |

| | | | |and procedures, and shall be required to |and potential hazards, and |

| | | | |follow them. |specifies practices and |

| | | | | |procedures to eliminate or |

| | | | | |minimize such hazards |

|Decontamination |Laboratory equipment and work surfaces |Equipment must be decontaminated before|All wastes from |Cleaning, Laundering, and Disposal. The | |

| |should be decontaminated with an |repair, maintenance, or removal from |laboratories and animal |employer shall clean, launder, and dispose of| |

| |effective disinfectant on a routine |the laboratory. |rooms are appropriately |personal protective equipment required by | |

| |basis, after work with infectious | |decontaminated before |paragraphs (d) and (e) of this standard, at | |

| |materials is finished, and especially |Laboratory equipment should be |disposal. |no cost to the employee. | |

| |after overt spills, splashes, or other |routinely decontaminated, as well as, | | | |

| |contamination by infectious materials. |after spills, splashes, or oth*er | | | |

| |Contaminated equipment must be |potential contamination. | | | |

| |decontaminated according to any local, | | | | |

| |state, or federal regulations before it|Equipment must be decontamin- | | | |

| |is sent for repair or maintenance or |ated before repair, maintenance, or | | | |

| |pack aged for transport in accordance |removal from the laboratory | | | |

| |with applicable local, state, or | | | | |

| |federal regulations, before removal | | | | |

| |from the facility. | | | | |

|Exposure Incidents |None |Incidents that may result in exposure |None |Following a report of an exposure incident, | |

| | |to infectious materials must be | |the employer shall make immediately available| |

| | |immediately evaluated and treated | |to the exposed employee a confidential | |

| | |according to procedures described in | |medical evaluation and follow-up, | |

| | |the laboratory biosafety safety manual.| |HIV and HBV Research Laboratories and | |

| | |All such incidents must be reported to | |Production Facilities: A spill or accident | |

| | |the laboratory supervisor. Medical | |that results in an exposure incident shall be| |

| | |evaluation, surveillance, and treatment| |immediately reported to the laboratory | |

| | |should be provided and appropriate | |director or other responsible person. | |

| | |records maintained. | | | |

|Gloves |None |None |Special care is taken to |Gloves shall be worn when it can be | |

| | | |avoid skin contamination |reasonably anticipated that the employee may | |

| | | |with organisms containing |have hand contact with blood, other | |

| | | |recombinant DNA molecules;|potentially infectious materials, mucous | |

| | | |gloves should be worn when|membranes, and non-intact skin; when | |

| | | |handling experimental |performing vascular access procedures except | |

| | | |animals and when skin |as specified in paragraph (d)(3)(ix)(D); and | |

| | | |contact with the agent is |when handling or touching contaminated items | |

| | | |unavoidable. |or surfaces. | |

| | | | | | |

| | | | |Disposable (single use) gloves such as | |

| | | | |surgical or examination gloves, shall be | |

| | | | |replaced as soon as practical when | |

| | | | |contaminated or as soon as feasible if they | |

| | | | |are torn, punctured, or when their ability to| |

| | | | |function as a barrier is compromised. | |

| | | | | | |

| | | | |Disposable (single use) gloves shall not be | |

| | | | |washed or decontaminated for re-use. | |

|Immunization and |Laboratory personnel receive |Laboratory personnel must be provided |None |The employer shall make available the |Appropriate medical |

|Medical Surveillance |appropriate immunizations |medical surveillance and offered | |hepatitis B vaccine and vaccination series to|evaluation, surveillance and |

| |or tests for the agents handled or |appropriate immunizations for agents | |all employees who have occupational exposure,|treatment should be provided |

| |potentially present in the laboratory |handled or potentially present in the | |and post-exposure evaluation and follow-up to|for all personnel in case of |

| |(e.g., hepatitis B vaccine or TB skin |laboratory. | |all employees who have had an exposure |need, and adequate medical |

| |testing). | | |incident. |records should be maintained.|

| | |Personal health status may impact an | | | |

| |Laboratory personnel receive |individual’s susceptibility to | | | |

| |appropriate immunizations or tests for |infection, ability to receive | | | |

| |the agents ha ndled or potentially |immunizations or prophylactic | | | |

| |present in the laboratory (e.g., |interventions. Therefore, all | | | |

| |hepatitis B vaccine or TB skin tes |laboratory personnel and particularly | | | |

| |ting). |women of child-bearing age should be | | | |

| | |provided with information regarding | | | |

| | |immune competence and conditions that | | | |

| | |may predispose them to infection. | | | |

| | |Individuals having these conditions | | | |

| | |should be encouraged to self-identify | | | |

| | |to the institution’s healthcare | | | |

| | |provider for appropriate counseling and| | | |

| | |guidance. | | | |

|Laundry |None |None |None |Contaminated laundry shall be handled as | |

| | | | |little as possible with a minimum of | |

| | | | |agitation. | |

| | | | |Contaminated laundry shall be bagged or | |

| | | | |containerized at the location where it was | |

| | | | |used and shall not be sorted or rinsed in the| |

| | | | |location of use. | |

| | | | |Contaminated laundry shall be placed and | |

| | | | |transported in bags or containers labeled or | |

| | | | |color-coded in accordance with paragraph | |

| | | | |(g)(1)(i) of this standard. When a facility | |

| | | | |utilizes Universal Precautions in the | |

| | | | |handling of all soiled laundry, alternative | |

| | | | |labeling or color-coding is sufficient if it | |

| | | | |permits all employees to recognize the | |

| | | | |containers as requiring compliance with | |

| | | | |Universal Precautions. | |

| | | | | | |

| | | | |Whenever contaminated laundry is wet and | |

| | | | |presents a reasonable likelihood of | |

| | | | |soak-through of or leakage from the bag or | |

| | | | |container, the laundry shall be placed and | |

| | | | |transported in bags or containers which | |

| | | | |prevent soak-through and/or leakage of fluids| |

| | | | |to the exterior. | |

| | | | |The employer shall ensure that employees who | |

| | | | |have contact with contaminated laundry wear | |

| | | | |protective gloves and other appropriate | |

| | | | |personal protective equipment. contaminated | |

| | | | |laundry off-site to a second facility which | |

| | | | |does not utilize Universal Precautions in the| |

| | | | |handling of all laundry, the facility | |

| | | | |generating the contaminated laundry must | |

| | | | |place such laundry in bags or containers | |

| | | | |which are labeled or color-coded in | |

| | | | |accordance with paragraph (g)(1)(i). | |

|Record-Keeping |None |None |None |Training records shall include the following |none |

| | | | |information: | |

| | | | |The dates of the training sessions; The | |

| | | | |contents or a summary of the training | |

| | | | |sessions; The names and qualifications of | |

| | | | |persons conducting the training; and The | |

| | | | |names and job titles of all persons attending| |

| | | | |the training sessions. Training records shall| |

| | | | |be maintained for 3 years from the date on | |

| | | | |which the training occurred | |

|Serum Collection and |When appropriate, considering the |Each institution must establish |When appropriate, | | |

|Storage |agent(s) handled, baseline serum |policies and procedures describing the |considering the agent(s) | | |

| |samples for laboratory and other |collection and storage of serum samples|handled, baseline serum | | |

| |at-risk personnel are collected and |from at-risk personnel. |samples for laboratory and| | |

| |stored. Additional serum specimens may | |other at-risk personnel | | |

| |be collected periodically, depending on| |are collected and stored. | | |

| |the agents handled or the function o f | |Additional serum specimens| | |

| |the facility. | |may be collected | | |

| | | |periodically depending on | | |

| | | |the agents handled or the | | |

| | | |function of the facility. | | |

| | | | | | |

|Sharps |Needles and syringes or other sharp | | | | |

| |instruments should be restricted in the| | | | |

| |laboratory for use only when there is | | | | |

| |no alternative, such as parenteral | | | | |

| |injection, phlebotomy, or aspiration of| | | | |

| |fluids from lab animals and diaphragm | | | | |

| |bottles. Plasticware should be | | | | |

| |substituted for glassware whenever | | | | |

| |possible. | | | | |

|Sharps |Only needle-locking syringes or | | | | |

| |disposable syringe needle units (i.e., | | | | |

| |needle is integral to the syringe) are | | | | |

| |used for injection or aspiration of | | | | |

| |infectious materials. | | | | |

| |Used disposa ble need les mu st not be | | | | |

| |bent, sheared, broken, recapped, | | | | |

| |removed from disposable syringes, or | | | | |

| |otherwise manipulated by hand before | | | | |

| |disposal; rather, they must be | | | | |

| |carefully place in conveniently located| | | | |

| |puncture-resistant containers used for | | | | |

| |sharps disposal. Non-disposable sharps | | | | |

| |must be placed in a hard-walled | | | | |

| |container for transport to a processing| | | | |

| |area for decontamination, preferably by| | | | |

| |autoclaving. | | | | |

|Sharps |Syringes which re-sheathe the needle, | | | | |

| |needleless systems, and other safety | | | | |

| |devices are used when appropriate. | | | | |

|Sharps |Broken glassware must not be handled | | | | |

| |directly by hand, but must be removed | | | | |

| |by mechanical means such as a brush and| | | | |

| |dustpan, tongs, or forceps. Containers | | | | |

| |of contaminated needles, sharp | | | | |

| |equipment, and brok en glass are | | | | |

| |decontaminated before disposal, | | | | |

| |according to any local, state, or | | | | |

| |federal regulations. | | | | |

|Sharps Injury Log |NA |NA |NA |The employer shall establish and maintain a |NA |

| | | | |sharps injury log for the recording of | |

| | | | |percutaneous injuries from contaminated | |

| | | | |sharps. The information in the sharps injury | |

| | | | |log shall be recorded and maintained in such | |

| | | | |manner as to protect the confidentiality of | |

| | | | |the injured employee. The sharps injury log | |

| | | | |shall contain, at a minimum: The type and | |

| | | | |brand of device involved in the incident, The| |

| | | | |department or work area where the exposure | |

| | | | |incident occurred, and an explanation of how | |

| | | | |the incident occurred. | |

|Spills |Spills and accidents that result in |Spills involving infectious materials |Spills and accidents which|HIV and HBV Research Laboratories and |A written procedure for the |

| |overt exposures to infectious materials|must be contained, decontaminated and |result in overt exposures |Production Facilities: All spills shall be |clean-up of all spills must |

| |are immediately reported to the |cleaned up by staff properly trained |to organisms containing |immediately contained and cleaned up by |be developed and followed. |

| |laboratory director. Medical |and equipped to work with infectious |recombinant |appropriate professional staff or others | |

| |evaluation, surveillance, and treatment|material. |DNA molecules are |properly trained and equipped to work with |All spills, accidents and |

| |are provided as appropriate and written| |immediately reported to |potentially concentrated infectious |overt or potential exposures |

| |records are maintained. |Spills involving infectious materials |the Institutional |materials. |to infectious materials must |

| | |must be contained, decontaminated, and |Biosafety Committee and | |be reported to the laboratory|

| | |cleaned up by staff properly trained |NIH/ORDA. | |supervisor. A written record |

| | |and equipped to work with infectious |Reports to NIH/ORDA shall | |of such accidents and |

| | |material. |be sent to the Office of | |incidents should be |

| | | |Recombinant DNA | |maintained. |

| | | |Activities, National | | |

| | | |Institutes of Health/ | | |

| | | |MSC 7010, 6000 Executive | | |

| | | |Boulevard, Suite 302, | | |

| | | |Bethesda, Maryland | | |

| | | |20892-7010, (301) | | |

| | | |496-9838. Medical | | |

| | | |evaluation, surveillance, | | |

| | | |and treatment are provided| | |

| | | |as appropriate and written| | |

| | | |records are maintained. | | |

|Training |The laboratory director ensures that |The laboratory supervisor must ensure | | | |

| |laboratory and support personnel |that laboratory personnel demonstrate | | | |

| |receive appropriate training on the |proficiency in standard and special | | | |

| |potential hazards associated with the |microbiological practices before | | | |

| |work involved, the necessary |working with BSL-2 agents. | | | |

| |precautions to prevent exposures, and |Spills involving infectious materials | | | |

| |the exposure evaluation procedures. |must be contained, decontaminated, and | | | |

| |Personnel receive annual updates or |cleaned up by staff properly trained | | | |

| |additional training as necessary for |and equipped to work with infectious | | | |

| |procedural or policy changes. |material. | | | |

|Transport of |Cultures, tissues, specimens of body | |Contaminated materials | | |

|contaminated materials|fluid s, or potentially infectious |Materials to be removed from the |that are to be | | |

| |wastes are placed in a container with a|facility for decontamination must be |decontaminated at a site | | |

| |cover that prevents leakage during |packed in accordance with applicable |away from the laboratory | | |

| |collection, handling, processing, |local, state, and federal regulations. |are placed in a durable | | |

| |storage, transport, or shipping. |Potentially infectious materials must |leak-proof container which| | |

| | |be placed in a durable, leak proof |is closed before being | | |

| | |container during collection, handling, |removed from the | | |

| | |processing, storage, or transport |laboratory. | | |

| | |within a facility. | | | |

|C. BL2 Safety Equipment (Primary Barriers) | | | |

|Biosafety |Properly maintained biological safety |All procedures involving the |Biological safety cabinets|Biological safety cabinets shall be certified|Biological safety cabinets, |

|Cabinets |cabinets, preferably Class II, or other |manipulation of infectious materials |(Class I or II) (see |when installed, whenever they are moved and |to be used whenever there is |

| |appropriate personal protective equipment or |that may generate an aerosol should be |Appendix G-III-L, |at least annually. |an increased risk of airborne|

| |physical containment devices are used. |conducted within a BSC or other |Footnotes and References | |infection, and procedures |

| | |physical containment devices |of Appendix G) or other | |with a high potential for |

| | | |appropriate personal | |producing aerosols are used. |

| | | |protective or physical | | |

| | | |containment devices are | | |

| | | |used. | | |

|Centrifuges |High concentrations or large volumes of |High concentrations or large volumes of|High concentrations or | | |

| |infectious agents are used. Such materials |infectious agents are used. Such |large volumes of organisms| | |

| |may be centrifuged in the open laboratory if |materials may be centrifuged in the |containing recombinant DNA| | |

| |sealed rotor heads or centrifuge safety cups |open laboratory using sealed rotor |molecules are used. Such | | |

| |are used, and if these rotors or safety cu ps|heads or centrifuge safety cups. |materials may be | | |

| |are opened only in a biological safety | |centrifuged in the open | | |

| |cabinet. | |laboratory if sealed beads| | |

| | | |or centrifuge safety cups | | |

| | | |are used and if they are | | |

| | | |opened only in a | | |

| | | |biological safety cabinet.| | |

|Coats, Gowns, or |It is recommended that laboratory coats, |Protective laboratory coats, gowns, |Laboratory coats, gowns, |All personal protective equipment shall be |Laboratory coveralls, gowns |

|Uniforms. |gowns, or uniforms be worn to prevent |smocks, or uniforms designated for |smocks, or uniforms are |removed prior to leaving the work area. |or uniforms must be worn at |

| |contamination or soiling of street clothes. |laboratory use must be worn while |worn while in the | |all times for work in the |

| | |working with hazardous materials. |laboratory. Before exiting|Laboratory coats, gowns, smocks, uniforms, or|lab. |

| |Protective laboratory coats, gowns, smock s, |Remove protective clothing before |the laboratory for |other appropriate protective clothing shall | |

| |or uniforms designated for lab use are worn |leaving for non-laboratory areas (e.g.,|non-laboratory areas |be used in the work area and animal rooms. |It is prohibited to wear |

| |while in the laboratory. This protective |cafeteria, library, administrative |(e.g., cafeteria, library,|Protective clothing shall not be worn outside|protective laboratory |

| |clothing is removed and left in the |offices). Dispose of protective |administrative offices), |of the work area and shall be decontaminated |clothing outside the |

| |laboratory before leaving for non-laboratory |clothing appropriately, or deposit it |this protective clothing |before being laundered. |laboratory, e.g. |

| |areas (e.g., cafeteria, library, |for laundering by the institution. It |is removed and left in the| |in canteens, coffee rooms, |

| |administrative offices). All protective |is recommended that laboratory clothing|laboratory or covered with|When there is occupational exposure, the |offices, libraries, staff |

| |clothing is either disposed of in the |not be taken home. |a clean coat not used in |employer shall provide, at no cost to the |rooms and toilets. |

| |laboratory or laundered by the institution; | |the laboratory. |employee, appropriate personal protective | |

| |it should never be taken home by personnel. | | |equipment such as, but not limited to, |Protective lab clothing that |

| | | | |gloves, gowns, laboratory coats, face shields|has been used in the lab must|

| | | | |or masks and eye protection, and mouthpieces,|not be stored in the same |

| | | | |resuscitation bags, pocket masks, or other |lockers or cupboards as |

| | | | |ventilation devices. Personal protective |street clothing. |

| | | | |equipment will be considered "appropriate" | |

| | | | |only if it does not permit blood or other | |

| | | | |potentially infectious materials 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 which the protective equipment will | |

| | | | |be used. | |

|Equipment & |None |Laboratory equipment should be |None |Engineering and work practice controls shall |Equipment such as autoclaves |

|Preventative | |routinely decontaminated, as well as, | |be used to eliminate or minimize employee |and biological safety |

|Maintenance | |after spills, splashes, or other | |exposure. Where occupational exposure remains|cabinets must be validated |

| | |potential contamination. | |after institution of these controls, personal|with appropriate methods |

| | | | |protective equipment shall also be used. |before being taken into use. |

| | | | | |Recertification should take |

| | | | |Engineering controls shall be examined and |place at regular intervals, |

| | | | |maintained or replaced on a regular schedule |according to the |

| | | | |to ensure their effectiveness. |manufacturer’s instructions |

| | | | | | |

| | | | |Equipment which may become contaminated with | |

| | | | |blood or other potentially infectious | |

| | | | |materials shall be examined prior to | |

| | | | |servicing or shipping and shall be | |

| | | | |decontaminated as necessary, unless the | |

| | | | |employer can demonstrate that decontamination| |

| | | | |of such equipment or portions of such | |

| | | | |equipment is not feasible. | |

|Eye wash |An eyewash station is readily available. |An eyewash station must be readily | |HIV and HBV Research Laboratories and | |

| | |available. | |Production Facilities: Each laboratory shall | |

| | | | |contain a facility for hand washing and an | |

| | | | |eye wash facility which is readily available | |

| | | | |within the work area. | |

|Eye Wear |Face protection (goggles, mask, face shield |Eye and face protection (goggles, mask,| |Masks, Eye Protection, and Face Shields. |Safety glasses, face shields |

| |or other splatter guard) is use d for |face shield or other splatter guard) is| |Masks in combination with eye protection |(visors) or other protective |

| |anticipate d splashes or sprays of infectious|used for anticipated splashes or sprays| |devices, such as goggles or glasses with |devices must be worn when |

| |or other hazardous materials to the face when|of infectious or other hazardous | |solid side shields, or chin-length face |it is necessary to protect |

| |the microorganisms must be manipulated |materials when the microorganisms must | |shields, shall be worn whenever splashes, |the eyes and face from |

| |outside the BSC. |be handled outside the BSC or | |spray, spatter, or droplets of blood or other|splashes, impacting objects |

| | |containment device. | |potentially infectious materials may be |and sources of artificial |

| |Protective eyewear should be worn for conduct| | |generated and eye, nose, or mouth |ultraviolet radiation. |

| |of procedures in which splashes of |Eye, face and respiratory protection | |contamination can be reasonably anticipated. | |

| |microorganisms or other hazardous materials |should be used in rooms containing | | | |

| |is anticipated. |infected animals as determined by the | | | |

| | |risk assessment. | | | |

|Gloves |Gloves should be worn if the skin on the |Gloves must be worn to protect hands | |HIV and HBV Research Laboratories and |Appropriate gloves must be |

| |hands is broken or if a rash is present. |from exposure to hazardous materials. | |Production Facilities: Special care shall be |worn for all procedures that |

| |Alternatives to powdered latex gloves should |Glove selection should be based on an | |taken to avoid skin contact with other |may involve direct or |

| |be available. |appropriate risk assessment. | |potentially infectious materials. Gloves |accidental contact with |

| | | | |shall be worn when handling infected animals |blood, body fluids and other |

| |Gloves are worn when hands may contact |Alternatives to latex gloves should be | |and when making hand contact with other |potentially infectious |

| |potentially infectious materials, |available. Gloves must not be worn | |potentially infectious materials is |material or infected animals.|

| |contaminated surfaces or equipment. |outside the laboratory. In addition, | |unavoidable. | |

| |Wearing two pairs of gloves may be |BSL-2 laboratory workers should: | | | |

| |appropriate. Gloves are disposed of when | | | | |

| |overtly contaminated, and removed when work |a. Change gloves when contaminated, | | | |

| |with infectious materials is completed or |integrity has been compromised, | | | |

| |when the integrity of the glove is |or when otherwise necessary. Wear two | | | |

| |compromised. |pairs of gloves when appropriate. | | | |

| |Disposable gloves are not washed, reused, or | | | | |

| |used for touching “clean” surfaces (keyboard |b. Remove gloves and wash hands when | | | |

| |s, telephones, etc.), and they should not be |work with hazardous materials has been | | | |

| |worn outside the lab. Alternatives to |completed and before leaving the | | | |

| |powdered latex gloves should be available. |laboratory. | | | |

| |Hands are washed following removal of gloves.| | | | |

| | |c. Do not wash or reuse disposable | | | |

| | |gloves. Dispose of used gloves with | | | |

| | |other contaminated laboratory waste. | | | |

| | |Hand washing protocols must be | | | |

| | |rigorously followed. | | | |

|Warning Labels |None |None |None |A readily observable label in accordance with| |

| | | | |paragraph (g)(1)(i)(H) shall be attached to | |

| | | | |the equipment stating which portions remain | |

| | | | |contaminated. | |

| | | | | | |

| | | | |Warning labels shall be affixed to containers| |

| | | | |of regulated waste, refrigerators and | |

| | | | |freezers containing blood or other | |

| | | | |potentially infectious material; and other | |

| | | | |containers used to store, transport or ship | |

| | | | |blood or other potentially infectious | |

| | | | |materials | |

| | | | | | |

| | | | |These labels shall be fluorescent orange or | |

| | | | |orange-red or predominantly so, with | |

| | | | |lettering and symbols in a contrasting color.| |

| | | | | | |

| | | | |Labels shall be affixed as close as feasible | |

| | | | |to the container by string, wire, adhesive, | |

| | | | |or other method that prevents their loss or | |

| | | | |unintentional removal. | |

|D. BL2 Facility Design (Secondary Barriers) | | | |

|Autoclave | | |An autoclave for |HIV and HBV Research Laboratories and |At Biosafety Level 2, an |

| | | |decontaminating laboratory|Production Facilities: An autoclave for |autoclave or other means of |

| | | |wastes is available. |decontamination of regulated waste shall be |decontamination should be |

| | | | |available within or as near as possible to |available in appropriate |

| | | | |the work area. |proximity to the laboratory. |

|Backflow |None |None |None | |A dependable supply of good |

| | | | | |quality water is essential. |

| | | | | |There should be no |

| | | | | |cross-connections between |

| | | | | |sources of laboratory and |

| | | | | |drinking-water supplies. An |

| | | | | |anti-backflow device should |

| | | | | |be fitted to protect the |

| | | | | |public water system. |

|Bench Tops |Bench tops are impervious to water and are |Bench tops must be impervious to water |Bench tops are impervious | |Bench tops should be |

| |resistant to moderate heat and the organic |and resistant to heat, organic |to water and resistant to | |impervious to water and |

| |solvents, acids, alkalis, and chemicals used |solvents, acids, alkalis, and other |acids, alkalis, organic | |resistant to disinfectants, |

| |to decontaminate the work surface and |chemicals. |solvents, and moderate | |acids, alkalis, organic |

| |equipment. | |heat. | |solvents & moderate heat. |

|Biological Safety|Install biological safety cabinets in such a |BSCs must be installed so that | |HIV and HBV Research Laboratories and | |

|Cabinet |manner that fluctuations of the room supply |fluctuations of the room air supply and| |Production Facilities:Biological safety | |

| |and exhaust air do not cause the biological |exhaust do not interfere with proper | |cabinets shall be certified when installed, | |

| |safety cabinets to operate outside their |operations. BSCs should be located away| |whenever they are moved and at least | |

| |parameters for containment. Locate biological|from doors, windows that can be opened,| |annually. | |

| |safety cabinets away from doors, from windows|heavily traveled laboratory areas, and | | | |

| |that can be opened, from heavily traveled |other possible airflow disruptions. | | | |

| |laboratory areas, and from other potentially | | | | |

| |disruptive equipment so as to maintain the |HEPA filtered exhaust air from a Class | | | |

| |biological safety cabinets’ air flow |II BSC can be safely re-circulated back| | | |

| |parameters for containment. |into the laboratory environment if the | | | |

| | |cabinet is tested and certified at | | | |

| | |least annually and operated according | | | |

| | |to manufacturer’s recommendations. BSCs| | | |

| | |can also be connected to the laboratory| | | |

| | |exhaust system by either a thimble | | | |

| | |(canopy) connection or a direct (hard) | | | |

| | |connection. Provisions to assure proper| | | |

| | |safety cabinet performance and air | | | |

| | |system operation must be verified. | | | |

|Carpets and Rugs |Carpets and rugs in laboratories are not |Carpets and rugs in laboratories are | | | |

| |appropriate. |not permitted. | | | |

|Cleanliness |The laboratory is designed so that it can be |The laboratory should be designed so |The laboratory is designed|Employers shall ensure that the worksite is |The laboratory should be kept|

| |easily cleaned. |that it can be easily cleaned and |so that it can be easily |maintained in a clean and sanitary condition.|neat, clean and free of |

| | |decontaminated. |cleaned. |The employer shall determine and implement an|materials that are not |

| | | | |appropriate written schedule for cleaning and|pertinent to the work. |

| | | | |method of decontamination based upon the | |

| | | | |location within the facility, type of surface| |

| | | | |to be cleaned, type of soil present, and | |

| | | | |tasks or procedures being performed in the | |

| | | | |area. | |

|Chairs |Chairs and other furniture used in laboratory|Chairs used in laboratory work must be | | | |

| |work should be covered with a non-fabric |covered with a non-porous material that| | | |

| |material that can be easily decontaminated. |can be easily cleaned and | | | |

| | |decontaminated with appropriate | | | |

| | |disinfectant. | | | |

|Decontamination | |A method for decontaminating all | | | |

| | |laboratory wastes should be available | | | |

| | |in the facility (e.g., autoclave, | | | |

| | |chemical disinfection, incineration, or| | | |

| | |other validated | | | |

| | |decontamination methods). | | | |

|Doors |Laboratories should have doors for access |Laboratory doors should be self-closing| |HIV and HBV Research Laboratories and |Doors should have vision |

| |control. |and have locks in accordance with the | |Production Facilities: Access doors to the |panels, appropriate fire |

| | |institutional policies. | |work area or containment module shall be |ratings, and preferably be |

| |Provide lockable doors for facilities that | | |self-closing. |self-closing. |

| |house restricted agents (as defined in 42 CFR| | | | |

| |72.6). | | | | |

|Emergency Back-Up|None |None |None | |There should be a reliable |

|Generators | | | | |and adequate electricity |

| | | | | |supply and emergency lighting|

| | | | | |to permit safe exit. A |

| | | | | |stand-by generator is |

| | | | | |desirable for the support of |

| | | | | |essential equipment, such as |

| | | | | |incubators, biological safety|

| | | | | |cabinets, freezers, etc., and|

| | | | | |for the ventilation of animal|

| | | | | |cages. |

|Eyewash |An eyewash station is readily available |An eyewash station must be readily | | | |

| | |available. | | | |

|First Aid Rooms | | | | |First-aid areas or rooms |

| | | | | |suitably equipped and readily|

| | | | | |accessible should be |

| | | | | |available |

|Laboratory |Laboratory furniture is capable of supporting|Laboratory furniture must be capable of|Laboratory furniture is | |Laboratory furniture should |

|Furniture |anticipated loading and uses. |supporting anticipated loads and uses. |sturdy. | |be sturdy. |

|Lighting |Illumination is adequate for all activities, | | | |Illumination should be |

| |avoiding reflections and glare that could | | | |adequate for all activities. |

| |impede vision. | | | |Undesirable reflections and |

| | | | | |glare should be avoided. |

|Security |None |None |None | |Laboratories and animal |

| | | | | |houses are occasionally the |

| | | | | |targets of vandals. Physical |

| | | | | |and fire security must be |

| | | | | |considered. Strong doors, |

| | | | | |screened windows and |

| | | | | |restricted issue of keys are |

| | | | | |compulsory. Other measures |

| | | | | |should be considered and |

| | | | | |applied,as appropriate, to |

| | | | | |augment Security Safety |

| | | | | |systems should cover fire, |

| | | | | |electrical emergencies, |

| | | | | |emergency shower and eyewash |

| | | | | |facilities. |

|Spaces |Spaces between benches, cabinets, and |Spaces between benches, cabinets, and |Spaces between benches, | |Facilities for eating and |

| |equipment are accessible for cleaning. |equipment should be accessible for |cabinets, and equipment | |drinking and for rest should |

| | |cleaning |are accessible for | |be provided outside the lab |

| |Consider locating new laboratories away from | |cleaning. | |working areas. |

| |public areas. | | | | |

| | | | | |Ample space must be provided |

| | | | | |for the safe conduct of |

| | | | | |laboratory work and for |

| | | | | |cleaning and maintenance. |

| | | | | | |

| | | | | |Open spaces between and under|

| | | | | |benches, cabinets and |

| | | | | |equipment should be |

| | | | | |accessible for cleaning. |

|Sink |Each laboratory contains a sink for |Laboratories must have a sink for hand |Each laboratory contains a|Employers shall provide hand washing |Hand-washing basins, with |

| |handwashing. |washing. The sink may be manually, |sink for hand washing. |facilities which are readily accessible to |running water if possible, |

| | |hands-free, or automatically operated. | |employees |should be provided in each |

| | |It should be located near the exit | | |laboratory room, preferably |

| | |door. | |HIV and HBV Research Laboratories and |near the exit door. |

| | | | |Production Facilities: Each work area shall | |

| | | | |contain a sink for washing hands and a | |

| | | | |readily available eye wash facility. The sink| |

| | | | |shall be foot, elbow, or automatically | |

| | | | |operated and shall be located near the exit | |

| | | | |door of the work area. | |

|Storage |None |None |None | |Storage space must be |

| | | | | |adequate to hold supplies for|

| | | | | |immediate use and thus |

| | | | | |prevent clutter on bench tops|

| | | | | |and in aisles. Additional |

| | | | | |long-term storage space, |

| | | | | |conveniently located outside |

| | | | | |the laboratory working areas,|

| | | | | |should also be provided. |

|Vacuum Lines |None |Vacuum lines should be protected with |None |HIV and HBV Research Laboratories and | |

| | |High Efficiency Particilate Air | |Production Facilities: Vacuum lines shall be | |

| | |filters, or their equivalent. Filters | |protected with liquid disinfectant traps and | |

| | |must be replaced as needed. Liquid | |high-efficiency particulate air (HEPA) | |

| | |disinfectant traps may be required. | |filters or filters of equivalent or superior | |

| | | | |efficiency and which are checked routinely | |

| | | | |and maintained or replaced as necessary. | |

|Ventilation |There are no specific ventilation |There are no specific requirements on |None |HIV and HBV Research Laboratories and |In the planning of new |

| |requirements. However, planning of new |ventilation systems. However, planning | |Production Facilities: A ducted exhaust-air |facilities, consideration |

| |facilities should consider mechanical |of new facilities should consider | |ventilation system shall be provided. This |should be given to the |

| |ventilation systems that provide an inward |mechanical ventilation systems that | |system shall create directional airflow that |provision of mechanical |

| |flow of air without recirculation to s paces |provide an inward flow of air without | |draws air into the work area through the |ventilation systems that |

| |outside of the laboratory. If the laboratory |recirculation to spaces outside of the | |entry area. The exhaust air shall not be |provide an inward flow of air|

| |has windows that open to the exterior, they |laboratory. | |recirculated to any other area of the |without recirculation. |

| |are fitted with fly screens. | | |building, shall be discharged to the outside,| |

| | | | |and shall be dispersed away from occupied | |

| | | | |areas and air intakes. The proper direction | |

| | | | |of the airflow shall be verified (i.e., into | |

| | | | |the work area). | |

|Windows |If the laboratory has windows that open to |Laboratory windows that open to the |If the laboratory has | |If there is no mechanical |

| |the exterior, they are fitted with fly |exterior are not recommended. However, |windows that open, they | |ventilation, windows should |

| |screens. |if a laboratory does have windows that |are fitted with fly | |be able to be opened and |

| | |open to the exterior, they must be |screens. | |should be fitted with |

| | |fitted with screens. | | |arthropod-proof screens. |

|Work Surfaces |Laboratory equipment and work surfaces should|None |None |HIV and HBV Research Laboratories and |Work surfaces must be |

| |be decontaminated with an effective | | |Production Facilities: The surfaces of doors,|decontaminated after any |

| |disinfectant on a routine basis, after work | | |walls, floors and ceilings in the work area |spill of potentially |

| |with infectious materials is finished, and | | |shall be water resistant so that they can be |dangerous material and at the|

| |especially after overt spills, splashes, or | | |easily cleaned. Penetrations in these |end of the working day. |

| |other contamination by infectious materials. | | |surfaces shall be sealed or capable of being | |

| |Contaminated equipment must be decontaminated| | |sealed to facilitate decontamination. | |

| |according to any local, state, or federal | | | | |

| |regulations before it is sent for repair or | | | | |

| |maintenance or pack aged for transport in | | | | |

| |accordance with applicable local, state, or | | | | |

| |federal regulations, before removal from the | | | | |

| |facility. | | | | |

|Walls |None |None |None | |Walls, ceilings and floors |

| | | | | |should be smooth, easy to |

| | | | | |clean, impermeable to liquids|

| | | | | |and resistant to the |

| | | | | |chemicals and disinfectants |

| | | | | |normally used in the |

| | | | | |laboratory. |

| | | | | |Floors should be |

| | | | | |slip-resistant. |

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