Chapter 26

BIOSAFETY

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Work Process D. Specific Biosafety Controls

This section further describes biosafety controls, including safe methods, equipment, and facilities that were generally introduced in Work Process C, Biosafety Principles and Levels.

1.   Work Authorizations

Berkeley Lab Job Hazards Analyses (JHAs), Subcontractor Job Hazards Analysis and Work Authorizations (SJHAWAs), and Biosafety Work Authorizations document the definition of work, identification of hazards, risk assessments, and controls. Biosafety Work Authorizations include:

PIs, work leads, workers, division safety coordinators, and EHS Division Biosafety Program personnel have access to their BUAs, BURs, and BUNs through the Biosafety Authorization System (BAS) so that controls may be implemented and authorizations updated. Documentation, review, and authorization of new work should be initiated by filling out the Biological Use Application form. See Work Process A, Starting and Conducting Work Safely, for additional information on these work authorizations.

These work authorizations consolidate and document a wide variety of biosafety requirements and controls to meet various biosafety standards. For example, the BUA is also regarded as:

a.   Institutional Biosafety Committee Review and Research Biosafety Authorization

In addition to worker-specific JHAs, work leads and principal investigators (PIs) must define their research projects or operations with biological materials, evaluate the biological hazards, implement biosafety containment controls, and ensure their work is documented and authorized as a BUN, BUR, or BUA. These authorizations are maintained in and accessible through the Berkeley Lab Biosafety Authorization System (BAS). See Table 10 for a summary of Institutional Biosafety Committee (IBC) review, documentation, and authorization requirements for research work with biological materials. The sections below provide additional explanation.

                                         i.    General Review and Authorization Process

The work lead and PI must ensure that research with biological materials and any regulatory permits are documented, reviewed by the IBC, and authorized under a Biosafety Work Authorization when and as required. Submission of a Biological Use Authorization Application form by the work lead or PI and approval by the IBC and line management results in a Biosafety Work Authorization (e.g., BUN, BUR, or BUA), as detailed in Table 10. EHS Division Biosafety Program personnel assist the work lead or PI in screening the work documentation, determining the applicable requirements and documentation, and coordinating the IBC review process.

Additionally, the work lead and PI must keep the work authorization documentation updated. This includes:

If a research project does not have funding that designates a PI, a project work lead will authorize or approve the authorization document. In addition, if the PI is not managing the work activities or safety, the PI may designate a project work lead to authorize or approve the work.

                                        ii.    Biological Use Notification

An approved BUN is required for work that involves only RG1 biological material or recombinant material exempted by NIH Guidelines and does not involve other conditions that require review (see Table 10). The PI-authorized BUN must be submitted to the IBC prior to or simultaneously with experiment initiation, and must receive concurrence by the Biosafety Officer or IBC Chair. This notification process at the start of a project defines and assesses the work, establishes containment levels, and ensures that the requirements and hazards for the project are correctly identified and addressed.

                                      iii.    Biological Use Registration

An approved BUR is required for work with RG1 recombinant biological materials that are covered by NIH Guidelines (i.e., recombinant DNA molecules or RG1 organisms and viruses containing recombinant DNA molecules). The PI-authorized BUR must be submitted to the IBC prior to or simultaneously with experiment initiation. The BUR must be reviewed and approved by the IBC.

                                      iv.    Biological Use Authorization

An approved BUA is required for research with biological materials that involve biohazardous materials (i.e., RG2 or higher materials, biological etiologic agents, select agents or toxins, or the use of BL2 containment for safety).

A BUA is a type of the Berkeley Lab “Formal Authorization” as defined in the ES&H Health & Safety Manual’s Safe Work Authorizations Program. The BUA meets ECP requirements and is also considered the OSHA-required ECP for the use of BBP materials and the BMBL-required laboratory-specific biosafety manual when work is performed with RG2 agents or materials at BL2. The PI-approved BUA requires full IBC review and approval, and authorization by the PI’s supervisor prior to commencing work.

Table 10. Berkeley Lab Review, Documentation, and Authorization for
Work with Biological Materials in Research

To determine work-review requirements for any given project with biological materials, classify the work types in accordance with the first column, and then select the highest-level authorization type indicated in the second column. Generally, work that involves recombinant DNA, RG2 agents, BL2, or BBP material has more stringent requirements. Further conditions that determine the level of review include requirements for specific regulatory permits, regulatory registrations, or funding agency assurance.

 

Biological Work Type

Berkeley Lab Authorization Type1

Required Biosafety Work Documentation (approximate renewal cycle)

Berkeley Lab Approval Process
IBC = Institutional Biosafety Committee
PI = principal investigator
BSO = Biosafety Officer

Risk Group 1

Work with RG1 biological material, including work with NIH-exempt2 recombinant DNA molecules

Line management
authorization

BUN
(3 years)

BUN process:

  • BSO reviews document for high-level administrative needs and work categorization.
  • PI and PI’s supervisor reviews and approves.
  • BSO notifies PI, supervisor, and EHS Div. Liaison.

RG1 work
with recombinant DNA molecules and organisms or viruses containing recombinant DNA molecules2

Registration

BUR
(2 years)

BUR process:

  • IBC reviews and approves. IBC Chair provides final IBC approval  on behalf of the IBC.
  • PI reviews and approves.
  • BSO notifies PI, supervisor, and EHS Div. Liaison.

Risk Group 2

RG22 or higher work, BL22 used for safety, or work with BBP materials as defined in Work Process B.3.f3

Formal authorization

BUA
(1 year)

BUA process:

  • IBC reviews and approves non-exempt recombinant work and work with RG2 agents. IBC Chair provides final IBC approval on behalf of the IBC.
  • BSO reviews work with RG2 or BBP materials or concerns and concurs.
  • PI and PI’s supervisor reviews and approves.
  • BSO notifies IBC Chair, PI, PI’s supervisor, Div. Safety Coordinator, and EHS Div. Liaison.

References
1. Authorization principles and types are specified in the ES&H Health & Safety Manual, Chapter 6 (Safe Work Authorizations), and the Integrated Environment, Safety & Health Management Plan: Integrated Safety Management (ISM) System (PUB-3140).
2. NIH Guidelines, the most recent version.
3. OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030.
4. In general, the renewal date of the authorization should also not extend beyond the expiration date of any regulatory permit covered by the authorization.

                                       v.    Exposure Control Plan

Work with or worker exposure to bloodborne pathogen materials defined in Work Process B.3.f, Bloodborne Pathogens and Human Materials  requires an Exposure Control Plan (ECP). The ECP must meet the requirements of the OSHA Bloodborne Pathogens Standard and must be authorized before work or designated job duties are initiated. If the work pertains to research, a BUA meets ECP requirements and is considered the OSHA-required ECP. If the work does not pertain to research, an ECP must be developed, authorized, and maintained by the supervisor or program manager and division line management.

                                      vi.    Human Subjects and Animal Use Approvals

Review and authorization of work that may have biosafety concerns related to use of humans, human-derived tissues, or animals must be conducted as described in the previous sections. General biosafety concerns include worker safety, public health, agricultural protection, and environmental protection (e.g., waste). Research involving human subjects or animals may also require review and approval by other processes and committees as summarized below.

Research involving human subjects, human-derived data, or human-derived tissues must be evaluated through ethical review using established principles and requirements. These requirements are based on U.S. Department of Health and Human Services (HHS) regulations and DOE orders. These standards require that an Institutional Review Board (IRB) review and approve any proposed research project involving human subjects before research begins. The IRB for Berkeley Lab is the Human Subjects Committee (HSC). See the HSC Web site and the ES&H Health & Safety Manual Research with Human and Animal Subjects program for additional information.

In addition, research involving vertebrate animals must comply with established standards and requirements for the care, treatment, and use of animals. These requirements are based on USDA animal welfare regulations and the U.S. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. Compliance with the PHS policy is overseen by the NIH Office of Laboratory Animal Welfare (OLAW). These standards require that the Berkeley Lab Animal Welfare and Research Committee (AWRC) review and approve proposed research that involves vertebrate animals and is performed at or funded through the Berkeley Lab before research begins. See the AWRC Web site and EHS Program, Research with Human and Animal Subjects for additional information.

While the HSC, AWRC, and IBC conduct separate review processes, they all request that researchers document in each application form that the appropriate committee has reviewed their research. See the HSC Web site, AWRC Web site and Chapter 22 of ESH Manual for additional information and requirements.

2.   Training, Instruction, and Qualification

This section describes the requirements and administrative systems for institutional and operation-specific training, information, and instruction based on the biosafety-related standards and Berkeley Lab policies.

Work leads, supervisors, and PIs must ensure their workers have sufficient skills, knowledge, and ability to perform their work safely. This includes understanding of the work, hazards, and controls through technical competence, training, instruction, and a commitment to safety in Integrated Safety Management (ISM) terms. Each worker’s competence must be commensurate with his or her responsibilities. This competence is a major component of biosafety containment and includes both required Berkeley Lab courses and sufficient operation-specific information and instruction. These courses, information, and instruction provide workers with awareness of the potential hazards, required training, and proficiency in the practices and techniques required for handling biological materials safely and in accordance with laboratory standard microbiological practices and special practices discussed in Work Process C.1, Laboratory Practices.

Work leads must provide or arrange for appropriate training and instruction for each person, including but not limited to the:

a.   Job Hazards Analysis

Supervisors, work leads, and staff must use the JHA or SJHA to define work with biological materials, determine the potential for exposure to biological hazards, and establish biosafety controls for each worker or subcontractor. The Laboratory-wide JHA identifies workers who work with or have potential exposure to biological materials (e.g., BBP materials). The JHA process is based on each individual’s work and activities. It also lists general controls including any required EHS courses and Biosafety Work Authorizations for work or activities in which the worker participates.

b.   Training Courses and Tracking

Specific biosafety, biohazardous waste, and occupational health courses are developed and maintained by the EHS Division to meet requirements that can be fulfilled at an institutional level. Berkeley Lab course requirements are presented below and summarized in Table 11. See the EHS Training Web site for additional course information, to register for a course, or to take an online course.

Table 11. Biosafety-Related Training Courses

Work Exposure or Role

EHS0739 Biosafety  Training for Researchers

EHS0730 Medical/ Biohazardous Waste Training

EHS0735 Bloodborne Pathogen Training for Researchers

EHS0738 Bloodborne Pathogen Training Refresher

EHS0745 Hepatitis B Medical Surveillance

EHS0749

PI rDNA Responsibilities

Researchers who use biological materials of any risk level, generate medical/biohazardous waste, or are PIs or leaders of the work activity

X

X

 

 

 

 

Researchers who use or are exposed to BBP materials

X

X

X

X

X

 

Nonresearchers who use or are exposured to BBP materials

 

 

 

X

X

 

PIs of non-exempt recombinant research

X

X

 

 

 

X

Biosafety training course requirements for each worker are identified through each worker’s JHA, and inclusion in the Personnel and Training sections of the Biosafety Work Authorization in the BAS. Each worker’s course requirements and training status are then displayed in the worker’s Training Profile, JHA Profile, and the Biosafety Work Authorization.

c.   Job-Specific Instruction, Information, and Practices

As discussed in Work Process D.2, Training, Instruction, and Qualification, supervisors and work leads must ensure that workers receive job- and operation-specific instructions. These instructions should include:

Additional instruction or demonstration of proficiency may be needed for work that involves higher hazards. For example, workers must demonstrate proficiency in standard microbiological practices and special practices before working with RG2 agents (for more information, see Work Process C.1, Laboratory Practices).

Labels and signs must also be used to advise workers of hazards and controls (see Work Process D.5, Labels and Signs).

3.   Occupational Health and Immunization

Text Box:  
Employee consultation with
Health Services. 
Source: Berkeley Lab EHS.
Employee consultation with Health Services. Source: Berkeley Lab EHS.

Berkeley Lab occupational health and immunization policies, programs, and services are provided by the Health Services Group of the EHS Division under the direction of the Site Occupational Medical Director (SOMD). These policies, programs, and services are described in the Health Services Web site, policies (e.g., immunization and serum banking), and the ES&H Manual Health Services program. The occupational health program related to biosafety is designed to proactively identify and prepare workers who may be exposed to certain biological materials or agents, and provide procedures for the treatment and management of workers who have been injured or may have been exposed. Employees who are aware of personal illnesses that may affect their ability to combat infection or receive medications or vaccines should visit Health Services for an evaluation of how this may affect their individual risk for work with biological agents.

Potential exposures to biological agents or materials that generate health concerns or may cause disease are assessed as part of the work review and authorization process discussed above in Work Process B, Work and Risk Assessment, and Work Process D.2, Training, Instruction, and Qualification. This assessment includes an evaluation and determination of the need for employee medical evaluations, immunizations, serum banking, or other occupational health controls. For research projects, this assessment is conducted by IBC members including the Biosafety Officer and the SOMD. The IBC review includes SOMD recommendations and is the basis of required or recommended occupational health controls for potentially exposed employees. These controls are then documented in the Biosafety Work Authorization.

Requirements or recommendations for occupational health controls (e.g., vaccinations) for specific agents or materials are discussed in BMBL, Section VIII (Agent Summary Statements). Requirements for BBP materials are provided by the OSHA Bloodborne Pathogens Standard. OSHA requirements and Berkeley Lab programmatic policies and systems for implementing these requirements are summarized below:

Text Box:  
Hepatitis B vaccine.
Source Berkeley Lab EHS.
Hepatitis B vaccine. Source Berkeley Lab EHS.

a.     Hepatitis B vaccination. The OSHA Bloodborne Pathogens Standard requires that the hepatitis B vaccination series be made available and offered to all Berkeley Lab employees who have occupational exposure to BBPs or materials that are regulated based on their potential to contain BBPs (e.g., human blood, tissues, and cells). This requirement is managed at Berkeley Lab by ensuring that workers who are potentially exposed to BBP materials are identified in their BUA or ECP and are required to complete EHS0745 (Hepatitis B Medical Surveillance). Each worker fulfills his or her hepatitis B surveillance requirement by: (1) completing the online EHS0745 course; (2) indicating on the course’s integral surveillance form that he or she has been previously immunized, wishes to be vaccinated, or wishes to decline the vaccination; and (3) competing any required follow-up process (e.g., getting vaccinated or documenting previous vaccination). When a worker indicates previous immunization, Health Services will work with him or her to document vaccination and document the results of such efforts.

b.      Post-exposure evaluation and follow-up. The OSHA Bloodborne Pathogens Standard requires that postexposure evaluations and follow-ups be made available to all employees who have had an exposure incident. Employees who have had an exposure incident must report their exposure to their supervisors and Health Services in accordance with Berkeley Lab’s Injury Response and Review program.

c.     Sharps injury log. The OSHA Reporting and Recording Occupational Injuries and Illnesses Standard requires a Sharps Injury Log for the recording of percutaneous injuries from sharps contaminated with BBP material (see 29 CFR 1904.8). The information in the Sharps Injury Log must be recorded and maintained in such a manner as to protect the confidentiality of the injured employee. The Sharps Injury Log must contain 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. This log may be maintained on the OSHA 300 Form, provided that the type and brand of the device causing the sharps injury is recorded, and sharps injury records may be easily separated from other types of work-related injuries and illnesses. Berkeley Lab maintains sharps injury information on the OSHA 300 Form in accordance with OSHA regulations. In addition, the Berkeley Lab Health Services Group maintains a separate, confidential log containing sharps injury information required by OSHA.

Consult the Berkeley Lab Health Services Group ([510] 486-6266), Health Services Web site, and ES&H Manual Health Services Program) for additional information. See Work Process D.10, Incident, Accident, and Emergency Response, for additional information on worker exposure, injury, and illness reporting.

4. Personal Protective Clothing and Equipment  

Use of safety equipment including personal protective equipment (PPE) is another element of BL1 and BL2 containment. PPE is clothing or equipment worn by workers to protect the body from injury by hazardous agents or materials. PPE may include foot, hand, eye, face, body, and respiratory protection.

PPE must be used, maintained, and disposed of in accordance with federal regulations, biosafety standards, and Berkeley Lab-specific PPE policies to prevent the spread of contamination and accidental infection. Berkeley Lab policies related to PPE when working with biological materials are described in this section and the following documents:

Text Box:  

  
Minimum area PPE: Safety glasses, long pants, and closed-toe shoes. Source: Berkeley Lab EHS.
Minimum area PPE: Safety glasses, long pants, and closed-toe shoes. Source: Berkeley Lab EHS.

The following PPE requirements are related to biosafety:

General requirements and conditions for use of PPE related to biosafety include:

a.   Body Protection

Text Box:  
Lab coat worn when working with biological materials. Source: Berkeley Lab EHS.
Lab coat worn when working with biological materials. Source: Berkeley Lab EHS.

Protective laboratory clothing is a garment such as a lab coat, gown, smock, or uniform designed to keep personal clothing, forearms, or other exposed bodily surfaces protected from contamination by biological materials or exposure to other hazards. The term "protective laboratory clothing” typically applies to garments worn in the laboratory, but may also apply to garments worn in nonlaboratory work (e.g., health care).

The following biosafety criteria are applicable to wearing protective laboratory clothing:

Protective laboratory clothing removed after use at BL2 or with biohazardous materials must be handled in one of the following ways:

    
Lab coats hung on separate hooks, placed in laundry bag at BL1, placed in laundry bag
that is red or marked with biohazard label at BL2 (i.e., RG2 and BBP materials), and
disposed as biohazardous waste. Source: Berkeley Lab EHS. 

Protective laboratory clothing and other laundry contaminated with RG2 materials should be handled as noted below, and laundry contaminated with BBP materials must be handled as follows:

b.   Eye and Face Protection

Text Box:  
Eye protection using 
safety glasses. 

 
Face splatter protection using face mask and shield. Source: Berkeley Lab EHS.
Eye protection using safety glasses.

Text Box:  
Eye protection using 
safety glasses. 

 
Face splatter protection using face mask and shield. Source: Berkeley Lab EHS.
Face splatter protection using face mask and shield. Source: Berkeley Lab EHS.

Eye protection is a safety device such as safety glasses with side shields or goggles worn over the eyes to prevent injury to the eye or exposure to biological agents. Face protection is a safety device such as a face mask, face shield, or other splatter guard worn over all or part of the face to protect the face from injury or exposure to biological agents. Face masks or respirators that are occasionally used for face protection are discussed in Work Process D.4.e, Respiratory Protection, Respiratory, and Face Masks.

Eye and face protection are used by laboratory and other workers to protect the eyes and face from splashes, splatters, or flying debris and hand-eye contact with biological materials. Contact by these means may result in injuries to the eyes and face or accidental inoculation via the eyes, nose, or mouth and subsequent infection and disease.

The risks noted above are prevented by using eye and face protection in accordance with the following requirements:

 

Text Box:  
Prescription safety glasses at Health Services. Source: Berkeley Lab EHS.
Prescription safety glasses at Health
Services. Source: Berkeley Lab EHS
.

Berkeley Lab provides prescription safety glasses when needed via the EHS Health Services Group and a staff optometrist. Personnel who need consultation or require prescription safety glasses should schedule an appointment with the optometrist by calling the Health Services Group at (510) 486-6266.

 

c.   Hand Protection

Hand protection is a glove or other safety device used on the hand to prevent injury to the hand or direct skin contact with biological materials. Hand protection is used by laboratory and other workers to protect the hands from harmful physical, chemical, biological, radiological, or other agents or hazards. These agents or hazards may cut, lacerate, abrade, or burn the skin; absorb through the skin; pass through breaks in the skin; or be spread as contamination. Although relatively few microbes can penetrate unbroken skin, many circumstances can cause a break in the skin, such as a cut or puncture from a sharp (see Work Process D.6.f.i, Sharps). In the case of biological materials, gloves prevent the worker’s hands, fingers, and nails from being contaminated. Spread of biological contamination from the worker’s exposed hands or contaminated gloves to the worker’s mucous membranes or other surfaces may also cause infection and disease in the worker or other people.

Gloves should be selected based on the hazards involved; they may need to serve multiple purposes. For example, gloves used for handling chemical and biological materials may need to be resistant to the chemicals being handled, liquid permeation, and physical damage. The remainder of this section is focused only on glove criteria that are important for biosafety and gloves that provide protection from biological materials or liquids.

    

From left: White latex gloves are worn to protect hands from exposure to biological materials,
organisms, patient mucous membranes, and blood. Purple nitrile gloves are used for the same
purposes and provide an alternative to latex. Double gloves are worn for extra protection.
Source: Berkeley Lab EHS.

The following criteria apply to glove selection, use, and disposal:

Text Box:  
See NIOSH Latex Allergy Prevention Guide. Source: NIOSH Web site 2013.
See NIOSH Latex Allergy Prevention Guide. Source: NIOSH Web site 2013.

d.   Foot Protection

Text Box:  
Closed-toe shoes. Source: Berkeley Lab EHS.
Closed-toe shoes. Source: Berkeley Lab EHS.

Footwear appropriate to the worker’s work activities and conditions must be worn at all times. In a Technical Area such as a laboratory, or areas where chemical or biological materials are stored or handled, closed-toe shoes must be worn at all times; open-toe shoes and sandals are not permitted. In some cases, Berkeley Lab requires workers to wear safety shoes for other hazards such as falling heavy objects. See Work Process B.2.b, Foot Protection, of the ES&H Manual Personal Protective Equipment (PPE) program, for additional information.

e.   Respiratory Protection, Respirators, and Face Masks

Workers who conduct procedures that may generate aerosols containing harmful levels of infectious agents must use controls such as biosafety cabinets (BSCs), enclosed containment systems, or respirators to avoid inhaling the agents. In general, a BSC should be used as the principal device in laboratories to contain infectious splashes or aerosols generated by numerous microbiological procedures (see Work Process D.6.d.ii, Hoods and Biosafety Cabinets, and Appendix E, Biosafety Cabinets, of this program for additional BSC information). Other engineered containment devices such as safety centrifuge cups should also be used. When engineering controls are not feasible or appropriate for the work, respirators may be needed to provide respiratory protection (e.g., potential exposure to airborne transmissible disease agents during patient care).

Text Box:  
A BSC is the principal laboratory device used to contain splashes or aerosols. Source: Berkeley Lab EHS.
A BSC is the principal laboratory device used to contain splashes or aerosols. Source: Berkeley Lab EHS.

Respirators or face masks are occasionally worn by workers while conducting work with biological materials. There are important differences in design, purpose, and requirements among types of respirators and face masks that may be used for biological materials:

The following requirements are applicable to respirator uses, regardless of why the respirator is worn:

5.   Labels and Signs

Text Box:  
Biohazard label. Source: 29 CFR 1910.1030(g)(1)
Biohazard label. Source: 29 CFR 1910.1030(g)(1)

Biological materials, agents, waste, potentially contaminated items, and laboratory rooms must be properly identified with labels, signs, or colors. Identification is needed so that responsibilities, material identities, hazards, or controls are communicated to workers, visitors, and others. These labels, signs, and colors must be displayed in accordance with Berkeley Lab policies and applicable requirements in the biosafety standards as summarized in this section.

A biohazard label or red color is typically required to provide warning when a biohazardous condition may be present. A biohazard label is a sign that is predominantly fluorescent orange or orange-red. It also contains a biohazard symbol and the word “Biohazard” in a contrasting color. The label shown here displays the required biohazard legend.

The following are biosafety criteria for labels, signs, and colors:

The following criteria must be implemented when posting an entrance to BL1 or BL2 laboratory area:

Caution placard at laboratory entrance with minimum area PPE requirements
and biohazard label indicating BL2 work area. Source: Berkeley Lab EHS.

6.   Facilities, Laboratory Equipment, and Related Practices

This section describes in a topical manner biosafety engineering and work practice controls related to standard facility design and laboratory equipment. Properly designed and used facilities, facility equipment, laboratory equipment, and lab tools provide protection for laboratory workers, persons outside the laboratory, the public, and the environment.

See Work Process C.1, Laboratory Practices; Work Process C.2, Safety and Personal Protective Equipment; and Work Process C.3, Facility Design and Construction, for a general discussion of the principles of standard laboratory practices, equipment, and facilities. See Appendix C, Laboratory Biosafety Level 1 and Biosafety Level 2 Criteria, of this program for a summary of standard laboratory practices, equipment, and facilities categorized as BL1 and BL2. See Work Process C.3 for a discussion of the facility design process at Berkeley Lab related to biosafety.

a.   Cleanable Surfaces and Furnishings

Text Box:  
Cleanable surfaces and furnishings. Source: Berkeley Lab EHS.
Cleanable surfaces and furnishings. Source: Berkeley Lab EHS.

In general, laboratory facilities and furnishings should be designed and maintained so that they are durable, will not trap contamination, and can be easily cleaned. The following BL1 and BL2 laboratory criteria specified by BMBL and apply to this objective:

b.   Doors and Windows

Laboratory doors and windows provide a means to control personnel access to the laboratory, control vectors such as insects and rodents, and maintain laboratory air-flow balance. These controls are elements of standard BL1 or BL2 laboratory practices or facilities.

The following biosafety criteria from BMBL and Appendix C are applicable to laboratory doors and windows:

    

Laboratory doors that are needed to control access, ventilation, vectors, or fire are kept
closed. BL2 doors are self-closing and have locks. Source: Berkeley Lab EHS.

c.   Plumbing Systems and Equipment

Plumbing-related systems and equipment that have requirements related to biosafety include handwashing sinks, sanitary sewer drains, water systems and backflow protection, emergency eyewash and shower units, and pipes. These systems provide needed utilities and containment when used properly. When used incorrectly, these systems may provide a route of exposure to personnel or the environment.

                                         i.    Text Box:  



Sinks and Hand-washing

BL1 and BL2 laboratories must have a sink with running water for hand-washing. In BL2 laboratories, the sink should be located near the exit door and may be manually, hands-free, or automatically operated. Hand-washing sinks should be provided with a soap dispenser and paper towel dispenser as a best management practice. When working with BBP materials, the sink facility is called a hand-washing facility. A hand-washing facility must have an adequate supply of potable running water, soap, and single-use towels or hot-air drying machines.

Text Box:  
Handwashing sink and facility. Source: Berkeley Lab EHS.
Handwashing sink and facility. Source: Berkeley Lab EHS.

Personnel working at BL1 or BL2 laboratories must wash their hands (a) after working with potentially hazardous materials, recombinant materials, and animals; (b) after removing gloves; and (c) before leaving the laboratory.

When work involves potential exposure to BBP materials outside of the laboratory (e.g., health care) and hand-washing facilities (e.g., potable water and a sink) are not feasible, an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes may be provided. When antiseptic hand cleansers or towelettes are used, hands must be washed with soap and running water as soon as possible.

                                      ii.    Drains and Disposal

Laboratory sinks must typically be drained into the sanitary sewer system. In general and as a best-management practice, liquids that contain biological material that is potentially viable or biologically active and not contaminated with other hazardous or radioactive material should be properly decontaminated with a disinfectant before disposal into the sanitary sewer system (see Work Process D.7, Decontamination, Waste, and Decommissioning) below. All biological liquid material considered medical/biohazardous waste must be decontaminated before disposal (see the Medical and Biohazardous Waste Generator’s Guide [PUB-3095]).

                                    iii.    Water Systems and Backflow Prevention

Text Box:  
Laboratory faucet with backflow-prevention device. Source: Berkeley Lab EHS.
Laboratory faucet with backflow-prevention device. Source: Berkeley Lab EHS.

Backflow-prevention devices are required in building water systems or connection points to prevent contaminated liquid or water from being inadvertently sucked into the potable-water system of the building. For example, a backflow-prevention device called a vacuum breaker is often integrated into the gooseneck of the laboratory sink faucet. This device prevents liquids from being drawn up into the faucet’s water system in case a laboratory worker connects tubing to the faucet’s serrated hose end.

Potable water is typically supplied to each laboratory building. This water supply is separated through backflow-prevention devices in the building’s plumbing system into potable- and industrial-water systems or sources. Plumbing fixtures that must be supplied with potable water include emergency eyewashes and showers and fixtures used in restrooms, in kitchens, or as drinking sources (e.g., toilets, sinks, or drinking faucets). Water connected to other fixtures or equipment in the laboratory or building must be separated from the fixtures that require potable water by proper backflow-prevention devices. When the water system is correctly designed and labeled, water pipes labeled as industrial water are separated from the potable-water system by a backflow-prevention device(s) in the building’s water system. Connection of laboratory sinks, laboratory equipment, or industrial equipment to pipes that also provide water to potable fixtures requires proper installation of a backflow-prevention device. Contact your building’s facilities service provider (e.g., Berkeley Lab Facilities) for proper plumbing advice and hardware.

                                    iv.    Emergency Eyewashes and Showers

Text Box:  
Using eyewash to flush face and eyes. Source: Berkeley Lab EHS.
Using eyewash to flush face and eyes. Source: Berkeley Lab EHS.

An emergency eyewash is a plumbing unit designed to properly flush chemical, biological, or other hazardous agents off the face and out of mucous membranes such as the eyes. Use of an eyewash prevents injury to the eye or exposed body surfaces. It also prevents an agent from penetrating into the body. An emergency eyewash must be readily available to BL2 work areas.

Ready access to a sink and emergency eyewash without strict distance-to-use requirements is normally sufficient for washing biological contamination from the body, because:

However, in areas where there is also a splash hazard to certain chemicals (e.g., corrosives, eye irritants, chemicals that are toxic via skin or eye contact), the CHSP specifies that a combination emergency eyewash and shower unit must be reachable within 10 seconds via an unobstructed path. When combination eyewash and shower units are provided for potential chemical exposures, the number and placement of units is often sufficient to also meet the biosafety requirement for an emergency eyewash being readily available in BL2 work areas. Installation, maintenance, and use of all emergency eyewash and shower units must comply with the eyewash and shower requirements in the CHSP.

d.   Ventilation and Hoods

Room ventilation and hoods provide for control of potential biological aerosols, other harmful atmospheres, odors, and smoke caused by fires by providing general room air dilution, directional air flow, and enclosure to contain and exhaust airborne agents. Room ventilation and hoods must be designed and maintained to established standards, guidelines, and Berkeley Lab policies.

                                        i.    Room Ventilation

The volume and balance of laboratory room ventilation are important safety controls. There may be specific ventilation requirements for specific laboratory uses, but the following design requirements generally apply to laboratory rooms that use biological and hazardous materials:

                                      ii.    Hoods and Biosafety Cabinets

Hoods are enclosures or shaped inlets designed to conduct contaminated air into an exhaust duct system, or a filter that safely captures the contaminant. This section discusses hoods designed to provide for the safety of the worker or the environment such as biosafety cabinets, laboratory fume hoods, exhausted equipment enclosures, gloveboxes, and other local exhaust points. This section does not cover ventilated enclosures such as laminar flow clean benches that are not designed to protect the worker or the environment from contaminated air.

Hoods used for safety must be designed, installed, tested, and surveyed in accordance with Berkeley Lab ES&H standards and policies for all hoods and high-efficiency particulate air (HEPA) filters (ES&H Manual Ventilation, Hoods, and HEPA Filters program). The EHS Industrial Hygiene Group manages the ventilation safety program and records hood locations, surveys, and testing in the Ventilation Database. Supervisors or work leads should ensure that hood safety survey stickers or labels indicate that the hood has been surveyed or tested and determined to be safe for use.

Berkeley Lab hood survey label indicating EHS checked biosafety cabinet status; Label indicating annual biosafety cabinet certfication

Biosafety cabinet survey and certification labels. Source: Berkeley Lab EHS.

1.   Biological Safety Cabinets and Other HEPA-filtered Containment

Text Box:  Biological safety cabinets or biosafety cabinets (BSCs) are hoods with HEPA filters that are designed to provide personnel, environmental, and product protection when appropriate practices and procedures are followed. Appendix E of this program summarizes BSC types and provides additional BSC information. Various types of BSCs and similar hoods are used at Berkeley Lab. Listed below are more common types:

BSCs or other safety equipment, PPE, or other physical containment devices (e.g., safety centrifuge cups) must be used whenever procedures with a potential to create infectious aerosols or splashes are conducted, or whenever high concentrations or large volumes of infectious agents are used. Examples of such procedures include pipetting, centrifuging, grinding, blending, shaking, mixing, vortexing, sonicating, opening containers with pressure differentials, or harvesting infected tissues. The BSC is the principal BL2 device used to provide containment of infectious splashes or aerosols generated by many microbiological procedures.

Text Box:  
Biosafety cabinet. Source: Berkeley Lab EHS.

Text Box:    
Aerosols and aerosol generation. Source: unidentified.

Biosafety cabinet. Source: Berkeley Lab EHS. Aerosols and aerosol generation. Source:
unidentified.

BSCs must be:

When a new BSC is needed or a BSC needs to be moved, contact the EHS Industrial Hygiene Group or Biosafety Office for assistance with selecting, testing, and decontaminating BSCs.

2.   Laboratory and Other Hoods

Other hoods that are not exhausted through HEPA filters are typically used for most nonbiological laboratory airborne hazards or concerns. These hoods are generally used for control of chemical hazards, gas hazards, process emissions, odors, and heat. Examples of such hoods include laboratory-type (“fume”) hoods, gas chromatograph local exhaust points, and autoclave canopy hoods. These hoods can be used for chemicals including biological toxins, but are not adequate for control of potential infectious biological aerosols or toxic particulate.

e.   Food Facilities and Eating

Text Box:  
Eating, drinking, and food storage outside the laboratory. Source: Berkeley Lab EHS.
Eating, drinking, and food storage outside the laboratory. Source: Berkeley Lab EHS.

Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption are not permitted in BL1 and BL2 laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.

 

f.     Laboratory Tools and Equipment

                                    i.    Sharps

This section describes types and hazards of sharps, states requirements from biosafety standards, and outlines Berkeley Lab’s policies on sharps related to biosafety. A sharp is an object that can penetrate the skin. A sharp is often a tool, device, or material that typically has a sharp edge or point such as a needle, scalpel, razor, blade, broken glass piece, broken capillary tube, or an exposed wire end.

Text Box:  
Sharps examples.
Source: Berkeley Lab EHS.
Sharps examples. Source: Berkeley Lab EHS.

Sharps may cause cut or puncture wounds. In addition, sharps contaminated with a biological material may result in the parenteral inoculation of a worker with an infectious or recombinant agent that may cause a laboratory-acquired infection or another disease. Parenteral is an adjective that refers to a route of administration that involves piercing the mucous membranes or skin barrier through events such as punctures, lacerations, abrasions, and bites.

Sharp tools are often designed with a built-in safety feature or mechanism that effectively reduces the risk of accidental skin penetration and a biological exposure incident. These tools are called safety-engineered sharps or safety-engineered needles. Examples include devices that blunt, sheathe, or withdraw the sharp when the sharp edge or point has been used or is not in use. The OSHA Bloodborne Pathogens Standard has specific definitions and requirements for the use of safety-engineered sharps that are discussed in the next section.

1.   Sharps Risk Assessment and Documentation

Use of sharps should be assessed as part of the risk assessment for work with biological materials. The following general process should be followed:

Text Box:  


Microtome enclosure, guarding, and blade. Source: Berkeley Lab EHS.
Text Box:  
Safety-engineered medical needles (sharps with ESIP). Source: Berkeley Lab EHS.
Microtome enclosure, guarding, and blade. Source: Berkeley Lab EHS. Safety-engineered medical needles (sharps with ESIP). Source: Berkeley
Lab EHS.

 

Use of sharps with RG2 materials should be documented in the BUA. In addition, use of sharps with BBP materials must be documented in the BUA or ECP, and the annual review and update of these plans must reflect changes in technology that eliminate or reduce exposure to BBPs (e.g., newly available devices designed to reduce exposure).

In addition, when the BUA or ECP covers medical procedures or devices that involve exposure to BBP material:

2.    Sharps Use and Disposal

Sharps must be used and disposed of in accordance with the Laboratory BL1 and BL2 criteria listed below and the Medical and Biohazardous Waste Generator’s Guide (PUB-3095).

    

Needles are not recapped. Used needles are placed directly in a sharps container. Sharps
containers are closed when two-thirds full. Broken glassware is removed using a broom
and dust pan. Source: Berkeley Lab EHS.


3.   Sharps Injury Reporting and Log

See Work Process D.10, Incident, Accident, and Emergency Response, for requirements and procedures related to injury and accident reporting, and Work Process D.3.C, Sharps Injury Log, for requirements and responsibilities related to logging sharps injuries.

                      ii.     Centrifuges

Rotational energies involved with most centrifuges can generate two serious hazards: mechanical failure, and dispersion of aerosols or droplets. This section describes general classes of centrifuges, and general operation and maintenance guidelines to minimize centrifuge hazards. Elements of these guidelines may or may not be applicable to specific centrifuge operations. Information in this section was adapted from the University of Minnesota’s Bio Basics Fact Sheet: Centrifuge Safety.

There are three general classes of centrifuges:

Centrifuges. Source: Berkeley Lab EHS.


1.   Centrifugation Operation Guidelines

Before centrifugation:

Text Box:        
Large and small centrifuge rotors, bottles, and tubes. Bottles and tubes with caps and seals. Source: Berkeley Lab EHS.

Large and small centrifuge rotors, bottles, and tubes. Bottles and tubes with caps and seals. Source: Berkeley Lab EHS.


During centrifugation:

After centrifugation:

Centrifuging RG2 materials:
imageFollow the safety procedures noted above plus:

2.   Centrifuge Maintenance Guidelines

Text Box:  
Centrifuge operation and maintenance manual. Source: Berkeley Lab EHS.
Centrifuge operation and maintenance manual. Source: Berkeley Lab EHS.

Moisture, chemicals, strong cleaning agents, and other substances can promote corrosion of centrifuge parts and cause centrifuge failure. Long-term centrifuge use may also cause centrifuge failure. The following are general maintenance recommendations:

                         iii.    Waste Containers

Containers used to hold medical/biohazardous waste, sharps waste, or pathological waste must be placed in biohazardous waste containers and bags in accordance with the Medical and Biohazardous Waste Generator’s Guide (PUB-3095).

                         iv.    Equipment Connected to Building Vacuum Systems

Text Box:  
Flask disinfectant trap with inline HEPA filter to protect the house vacuum system. Source: Berkeley Lab EHS.
Flask disinfectant trap with inline HEPA filter to protect the house vacuum system. Source: Berkeley Lab EHS.

House vacuum systems used to evacuate air from containers, enclosures, or lines that contain biological materials should be equipped with a HEPA filter (or equivalent filter) to prevent biological materials or aerosols from being sucked inadvertently into the vacuum line. This is a general guideline for all biological materials, but the BMBL criteria for BL2 laboratory facilities specifically states that vacuum lines should be protected with a HEPA filter or equivalent, the filter must be replaced as needed, and liquid disinfectant traps may be required. Liquid disinfectant traps and filters typically used in conjunction with tissue culture work inside a BSC are further detailed in Appendix E, Section E.3.3, of this Biosafety Program.

7.   Decontamination, Waste, and Decommissioning

Work surfaces, work areas, furniture, equipment, materials, and wastes involved in most work with biological materials must be routinely decontaminated during the work, and prior to transfer or disposal. This section (1) discusses principles of decontamination; (2) provides examples of antimicrobials used to decontaminate; and (3) summarizes or references requirements from the standards related to antimicrobials and decontamination of surfaces, equipment, and wastes. See the following policy sections and standards for additional information:

a.   Text Box:  Decontamination Processes and Antimicrobials

Decontamination is a process that uses an antimicrobial to reduce or inactivate biological contaminants or components to an acceptable level so as to reduce or eliminate the possibility of transmitting pathogens to undesired hosts. An antimicrobial is a chemical or physical agent that is used in a decontamination process to prevent microbial growth. Prevention of microbial growth and pathogen transmission is needed to control contamination of the work, and to prevent disease in hosts such as laboratory workers, the general public, and other organisms in the environment. The decontamination process, level, antimicrobial, frequency, and specific method should be based on the work activity, agents that need inactivation, and decontamination objectives or requirements. Decontamination and waste disposal must be conducted in accordance with the following standards and requirements:

Text Box:  
Antimicrobial information. Source: Berkeley Lab EHS.
Antimicrobial information. Source: Berkeley Lab EHS.

Definitions of decontamination processes and levels, along with common examples of antimicrobials and processes, are listed in Table 12 below. Refer to Appendix F of this manual for additional information on decontamination and antimicrobials.

When using a chemical or physical antimicrobial to ensure decontamination is accomplished for biosafety purposes (i.e., protection of workers, public, agriculture, or environment):

Antimicrobial information in Appendix F of this manual, information provided by manufacturers (e.g., labels or technical specifications), and other information may be used for selecting and using the appropriate antimicrobial. Effective decontamination can also be ensured by using an Environmental Protection Agency (EPA)-registered or Food and Drug Administration (FDA)-cleared antimicrobial product within its manufacturer-specified limits. See Appendix F, Section F.2.3, of this manual for additional information on commercial disinfectants and sterilants registered or cleared by the EPA and FDA.

Table 12. Decontamination Processes, Levels, and Antimicrobial Examples*

General Decontamination Process and Level

Antimicrobial
Example

Example Decontamination Process

Sterilization is the process of completely destroying or eliminating all living microorganisms and viruses.

Wet heat-steam

Autoclave at 121°C (250°F) for 15 minutes or more.

Dry heat

Bake at 171°C for at least 1 hour, or Incinerate.

Wet or dry heat

Place solid waste in a biohazardous-waste container for autoclaving or incineration by a licensed Berkeley Lab subcontractor.

Disinfection is the process of generally destroying or irreversibly inactivating nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate surfaces or objects.

Chlorine in sodium hypochlorite

Wipe clean hard work surfaces and equipment with a 1% solution of fresh household bleach, and allow to air dry for intermediate-level disinfection.

Add household bleach to liquid biohazardous spills or liquid waste until a 10% concentration of household bleach is achieved for 20 minutes for high-level disinfection.

Ethyl or isopropyl alcohol

Wipe clean hard work surfaces with a 70% solution of alcohol for low-level disinfection.

Submerge precleaned items in 70% alcohol for 10 minutes for intermediate-level disinfection.

Iodine

Wipe clean hard work surfaces with an idophor such as Wescodyne® for intermediate-level disinfection.

Formaldehyde

Use formaldehyde in water (i.e., formalin) or in alcohol at 1% to 8% for low- to high-level disinfection, respectively.

Ultraviolet (UV) light

UV light inside biosafety cabinet. Not recom-mended as a biosafety control because disinfection is limited, and light damages human tissue.

Sanitization is the process of generally reducing, but not necessarily eliminating, microbes from the inanimate environment to levels that are considered safe by public health standards.

Sanitizer products designed for food or nonfood contact

Using a sanitizer in a toilet bowl tank, laundry-service clothes washer for laboratory coats, laboratory dishwasher for laboratory glassware, kitchen dishwasher for food dishes, cage washer for animal cages, or clean-in-place process units for large-scale fermenters

Antisepsis is the application of a liquid antimicrobial chemical to human or animal living tissue.

Iodine

Wash hands with Betadine® skin cleanser containing povidone-iodine (PVP-I), or apply 10% PVP-I solution in water to the injection site on a research animal.


* See Appendix F of this manual for additional information and specific conditions.

  

Decontamination processes and antimicrobials: autoclave sterilization with wet
heat-steam, low-level surface disinfection with alcohol, glassware sanitization by
washing with cleaners. Source: Berkeley Lab EHS.


Steam heat used in autoclaves is also a common laboratory antimicrobial. An autoclave is a piece of equipment with a chamber used to sterilize items by applying wet heat (i.e., high-pressure steam) at temperatures above the normal boiling point of water and pressures above normal atmospheric pressure. Autoclaves are used to sterilize laboratory equipment or materials such as glassware, media, reagents, or waste. See Appendix F, Section F.5, of this manual for general information and guidelines on autoclave principles, operation, and maintenance typically needed to sterilize equipment and ensure operator safety.

The OSHA Bloodborne Pathogens Standard requires that work surfaces contaminated with BBP material (as defined in Work Process B.3.f) must be cleaned with an “appropriate disinfectant.” Appropriate disinfectants include household bleach diluted to concentrations ranging from 1% (i.e., 1:100) to 10% (i.e., 1:10) in water and certain disinfectants registered by the EPA or FDA. Household bleach at these concentrations is one of the most common and effective disinfectants used in the laboratory. Household bleach is a water-based solution of sodium hypochlorite (NaOCl) with a typical concentration of 5.25% by weight of the active sodium hypochlorite ingredient. In the U.S., Clorox® bleach is the best-known brand. See Appendix F, Section F.3.2.1, of this program for additional details on the properties and use of bleach.

 

How to mix, use, and store bleach so that it is effective

 

Wipe hard work surfaces and equipment with 1% solution of fresh household bleach and allow to air dry

 

Add household bleach to liquid biohazardous spills or liquid waste until a 10% concentration of bleach is achieved for 20 minutes.

Household bleach is a water-based solution of sodium hypochlorite (NaOCl) with a typical concentration of 5.25% by weight of the NaOCl active ingredient. Manage bleach’s decay in antimicrobial activity by:

  • Mixing fresh, daily solutions of diluted bleach
  • Storing bleach under favorable conditions, dating bottles, rotating stock, and disposing of older bleach (e.g., greater than 6 to 12 months) 
Source: Berkeley Lab EHS

b.   Surface and Equipment Decontamination

In general, surface and equipment decontamination guidelines for BL1 and BL2 areas include:

 

Work areas cleaned and maintained in a sanitary condition. Surfaces
are routinely decontaminated. Source: Berkeley Lab EHS.

Text Box:  
Work surfaces are decontaminated after completion of work or potential contamination. Source: Berkeley Lab EHS.
Work surfaces are decontaminated after completion of work or potential contamination. Source: Berkeley Lab EHS.

Laboratory standard microbiological practices from BMBL and NIH Guidelines (see Appendix C of this manual) specifically require the following surface and equipment decontamination practices:

c.   Waste Decontamination and Disposal

Laboratory standard microbiological practices and special practices from BMBL and NIH Guidelines (see Appendix C of this manual) for BL1 and BL2 specifically require that all cultures, stocks, and other potentially infectious or viable recombinant materials must be decontaminated before disposal using an effective method. Effective decontamination methods are covered in Work Process D.7, Decontamination, Waste, and Decommissioning; and Appendix F, Decontamination and Antimicrobials, of this manual. Responsibility for decontamination starts with the waste generator. In some cases, the waste generator performs the actual decontamination. In other cases, the generator selects the decontamination system and then prepares the waste materials for treatment by others.

Text Box:  
Contaminated items considered medical/biohazardous waste. Michigan State University, Office of Radiation, Chemical, and Biological Safety (May 2010).
Contaminated items considered medical/ biohazardous waste. Michigan State University, Office of Radiation, Chemical, and Biological Safety (May 2010).

Berkeley Lab uses the term “medical/biohazardous waste” to describe wastes that are biological materials or that may be contaminated with biological materials and requires inactivation (i.e., decontamination) in an approved manner prior to final disposal. See the Medical and Biohazardous Waste Generator’s Guide (PUB-3095) for Berkeley Lab definitions and requirements for disposal of medical/biohazardous waste. Decontamination, collection, and disposal of medical/biohazardous waste will be conducted in accordance with PUB-3095, methods approved or known to inactivate the materials, and any requirements specified in regulatory permits (e.g., USDA) issued to individuals

The EHS Division Waste Management Group manages the disposal of Berkeley Lab medical/biohazardous waste. It also manages the contract with a licensed subcontractor that transports, treats, and disposes of Berkeley Lab’s solid waste as regulated medical waste. Examples of such solid waste include materials that are placed in lined and labeled biohazardous waste containers, biologically contaminated sharps in sharps containers, and pathological materials such as carcasses.

Although the Waste Management Group manages the waste component of the Biosafety Program, it is the responsibility of the waste generator to ensure that medical/biohazardous waste is properly:

 

Sharps Container Drop Needle Syringe3Sharps container

Biohazardous waste container with clear biohazard bag

Decon Waste Bio Container Bag BarrelBiohazardous waste container, red biohazard bags, and gray pickup container


Labeled and color-coded biohazardous sharps container, waste containers, and autoclave bags. Source: Berkeley Lab EHS. Consult the Medical and Biohazardous Waste Generator’s Guide (PUB-3095) for details on labels and colors for sharps containers, waste containers, and waste bags in designated red-bag or clear-bag areas. A determination must be made in the Biosafety Work Authorization as to whether the work will generate either regulated medical waste (i.e., red-bag waste that is regulated by the California Department of Health Services) or nonregulated biohazardous waste not (i.e., clear-bag waste).

The Joint Genome Institute (JGI) is the only Berkeley Lab site that does not use a licensed subcontractor to dispose of solid biological waste as regulated medical waste. Instead, JGI uses autoclaves to sterilize solid, recombinant, biohazardous waste prior to disposal as detailed in PUB-3095.

d.   Laboratory and Equipment Decommissioning and Moves

All surfaces and equipment should be cleaned and put into a safe condition prior to vacating laboratory spaces or relocating equipment. The Laboratory’s Space Management Policy in the Requirements and Policies Manual requires that laboratory and shop spaces be cleared of debris and contamination prior to transfer of ownership. The decommissioning section of the CHSP provides a good general description of requirements and resources for decommissioning laboratories and equipment.

Decommissioning should include decontamination and waste-disposal methods appropriate for the biological materials that may be present and the materials or equipment to be decontaminated. Decommissioning may include requirements that:

Custodians of equipment that will be moved by the Berkeley Lab Transportation Department must verify that the equipment is free of biological, chemical, and radiological hazards. This verification is accomplished when the equipment custodian places a completed Berkeley Lab Transportation Authorization Form on each piece of equipment to be transported (see ES&H Manual Hazardous Materials Transportation Program). Transportation Authorization Forms are issued to equipment custodians when they request an equipment move through the Work Request Center.


 

8.   Access and Security

Laboratory supervisors and work leads conducting work at BL1 or BL2 must enforce Berkeley Lab institutional policies that control access to the site and to laboratory facilities as described in the Berkeley Lab Site Security Plan. Policies and practices include, for example, the hosting of visitors and the issuance of gate passes, badges, and/or keys to control access to the site, building, and/or room based on each individual’s business needs. In addition, laboratory areas should have doors for access control. Consult the Integrated Safeguards and Security Management Web site for security policies and additional information.

  

Laboratory supervisors and leaders control access to the laboratory and advise
entering persons of the hazards and entry requirements. Source: Berkeley Lab EHS.

In addition to the above access requirements, the following additional controls are applicable when working at BL2:

http://www.lbl.gov/ehs/biosafety/manual/assets/img/5.0_image066.jpgAdditional security assessments and security measures should be considered when select agents, other agents of high public health or agricultural concern, or agents of high commercial value are introduced into the laboratory. In this case, advisory recommendations of Section VI (Principles of Laboratory Biosecurity) of BMBL should be considered. In addition, when a security risk assessment has determined that additional physical security measures are needed to mitigate specific vulnerabilities, the laboratory or facility may be designated a property protection area. Lastly, when the agents are select agents or toxins (see Work Process B.3.d, Pathogenic Agents and Toxins), then the security requirements of the select agent regulations must be implemented as outlined in a specific security plan for the laboratory or building. The term “biosecurity” is often used to describe the administrative and physical security measures used to protect higher-consequence microbial agents or toxins from loss, theft, diversion, or intentional misuse.

9.   Pest ManagementText Box:

Biosafety level (e.g., BL1 and BL2) criteria in BMBL and the NIH Guidelines require a program to control pests such as insects and rodents. Pests such as flies, cockroaches, ants, or mice can mechanically transmit biological materials and pathogens.

Text Box:  
Fly paper in greenhouse. Source: Berkeley Lab EHS.
Fly paper in greenhouse. Source: Berkeley Lab EHS.

Text Box:  Appendix G of BMBL provides guidance and requirements for Integrated Pest Management (IPM). IPM is a comprehensive program approach that integrates housekeeping, maintenance, and pest control services. The primary goal of IPM is to prevent pest problems by managing the facility environment to make it less conducive to pest infestation. Along with limited applications of pesticides, pest control is achieved through proactive operational and administrative intervention strategies to correct conditions that foster pest problems. Research supervisors, work leads, and Berkeley Lab Facilities are each responsible for elements of IPM for each operation.

The Berkeley Lab Facilities Division is responsible for the general construction and maintenance of facilities including the design of laboratory buildings, periodic floor cleaning, disposal of general trash, and pest management. Pest management includes maintenance of a contract with a licensed California state/county applicator to provide insect and rodent control services. The licensed applicator conducts preventative services (e.g., periodically spraying the foundation of a building) and controls reported infestations. The Facilities Division also maintains the Facilities Work Request Center (510-486-6274) to track and respond to requests to repair and clean facilities and control infestations.

Text Box:  
 
Facilities pest control services. Source: Berkeley Lab EHS.
Facilities pest control services. Source: Berkeley Lab EHS.

Research supervisors and work leads must ensure implementation of the following IPM elements:

The following general guidelines may be used to prevent or control rodent infestations:

See Appendix G, Biological Spills and Cleanup, of this manual for guidelines on the cleanup of small dead animals, nests, or droppings.

10.       Incident, Accident, and Emergency Response

This section outlines policy-related incident response and reporting. Biosafety-related incidents may include worker exposure to biological material, injuries or illnesses involving or resulting from exposure to biological material, spillage of biological material, or release of biological material outside of biosafety secondary containment. Such incidents may require reporting, medical evaluation and treatment, emergency response, incident review and documentation, and/or corrective actions.

Response to biosafety-related incidents will be managed in accordance with this section and the following guidelines, policies, and authorizations:

Text Box:  a.   General Incident Response and Reporting

ES&H Manual Injury Response and Review program also provides general requirements for incident reviewing and reporting such as responding to emergencies and reporting and reviewing incidents and occupational injuries or illnesses.

Worker instructions for reporting incidents and general emergency response are covered in the Berkeley Lab Emergency Guide. This guide provides response guidelines for a variety of common emergencies, including biological spills and personal injury. It also provides both emergency and nonemergency telephone numbers. The guide is available on the Emergency Services Web site and as a wall-mountable flip chart. The Emergency Guide must be posted in areas wherever work with biological materials is conducted, and emergency response guidelines should be employed when responding to incidents.

Text Box:ES&H Manual Injury Response and Review program also provides general requirements for incident reviewing and reporting such as responding to emergencies and reporting and reviewing incidents and occupational injuries or illnesses.

Division directors and their designees are also responsible for reporting certain adverse or abnormal occurrences in accordance with ORPS polices and system. In addition to ORPS reporting, incidents of security concern must be reported to Berkeley Lab Security.

b.   Worker Exposure, Injury, or Illness

Text Box:  
Puncture wound and potential exposure to biological materials. Source: Berkeley Lab EHS.
Puncture wound and potential exposure to biological materials. Source: Berkeley Lab EHS.

Workers are responsible for immediately reporting all occupational injuries, illnesses, and exposures to biological materials of concern to their supervisor and Health Services. The Biosafety Officer must also be notified of exposures to biological materials of concern or any related illness. Health Services will manage the occupational health case and initiate a Supervisor Accident Analysis Report (SAAR). In addition, an incident review team will be assigned to review the case and determine the causes and any needed actions. See ES&H Manual Injury Response and Review program for additional information.

Biological materials of concern related to exposures include materials or animals that may contain agents or properties that have known, potential, or unknown health risks. Examples of materials include all recombinant genomic materials, viable biological microbes in research, or RG2 or higher agents or materials. Examples of worker exposures to such biological materials of concern include:

Additional information on biosafety-related accidents, response, and reporting is contained in the applicable BUA or ECP (see Work Process D.1, Work Authorizations)

c.   imageimageBiological Spills and Cleanup

Supervisors, work leads, and PIs must ensure that spill-response procedures and materials needed to safely respond to biological spills are maintained in operations where biological materials are used.

Text Box:  
Biological spill. Source: Berkeley Lab EHS.
Biological spill. Source: Berkeley Lab EHS.

The Emergency Guide, which must be posted in work areas, provides guidance and materials needed to safely respond to and clean up most biological spills at Berkeley Lab. Additional guidance regarding a variety of biohazardous spills inside and outside of biosafety cabinets is provided in Appendix G. Any additional guidance or materials needed to safely respond to or clean up biological spills must be included in the operation’s Biosafety Work Authorization (see Work Process D.2).

Response to biological spills should be conducted in accordance with applicable guidelines or requirements contained in the Biological Incidents section of the Emergency Guide, Appendix G of this manual, and the operation’s Biosafety Work Authorization.

d.   Additional Biosafety Incident Reporting

Line management, the Biosafety Officer, the Responsible Official, Waste Management, the IBC, and other Berkeley Lab employees have various internal and regulatory responsibilities for reporting biosafety-related incidents. The following incidents must be reported to the Biosafety Officer in the EHS Division:

Release outside of secondary containment includes, for example:

11.               Procurement, Transportation, and Transfer

a.   Procurement

Procurement of biological agents, biological toxins, and other selected laboratory equipment or supplies are controlled at Berkeley Lab using a graded approach through the procurement process. These controls are designed to screen for biosafety and other hazards. They also provide a means for EHS to assist requestors in implementing biosafety controls or complying with regulations. The following Berkeley Lab procurement controls are related to biosafety:

bus

b.   Transportation and Shipping

Employees who wish to transport or ship a biological material must ensure the material is moved safely and in accordance with Berkeley Lab biosafety transportation and shipping policy detailed in Appendix H of this manual. Appendix H should be used to assess whether the material is a regulated biological material and how it should be moved. Berkeley Lab’s policy for workers handling materials at the Laboratory is based on biosafety requirements and U.S. and international transportation and shipping regulations. A number of biological materials may be transported directly by Berkeley Lab researchers in accordance with Laboratory requirements, but all biological materials shipped by a contracted shipping company (e.g., a common carrier such as FedEx or UPS)  must be moved through Berkeley Lab Receiving, Transportation, and Shipping. See Appendix H for additional information.

Borders

c.   Import, Export, and Transfer Restrictions

Materials being transferred (i.e., imported, exported, or transferred) from one location or person to another may be subject to regulatory restrictions or permit requirements. U.S., state, and foreign government agencies restrict and permit the movement of certain biological materials across borders to prevent threats to public health, agriculture, environment, and national security.

The supervisor, work lead, person transferring the biological material, person requesting transfer of the biological material, and permit holder all have Berkeley Lab or legal responsibilities for complying with transfer requirements, obtaining any required permits, and following the conditions of the permit. Regulatory requirements, permits, and permit conditions related to the transfer of biological materials should also be included in the Biosafety Work Authorization. The Berkeley Lab Biosafety Office and IBC will review the researcher’s assessment and documentation of transfer requirements during the work-authorization review process.

Appendix I of this manual provides an outline of U.S.-based regulatory restrictions, permits, and lists related to the transfer (i.e., import, export, or transfer) of biological and related materials. Appendix I may be used by Berkeley Lab personnel as a starting point for determining whether biological materials are potentially regulated by U.S. agencies. It may also be used to determine whether there are restrictions or permits applicable to transfer of the material. Contact the Berkeley Lab Biosafety Office for additional advice.

General controls for exporting from Berkeley Lab are outlined in the Berkeley Lab Export Control Program. Export controls are based on government rules and regulations that govern the transfer of the following items to non-U.S. entities or individuals, regardless of where or how the transfer takes place:

 

 

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