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The work scope must be defined and hazards and risks must be assessed before work begins. These work-planning processes are the first two core ISM functions and required by biosafety standards. Biological work and risks at Berkeley Lab are defined using established institutional assessment and authorization processes, a structured approach as required by DOE, and the standard biosafety risk assessment process defined by the CDC and NIH. It is a primary responsibility of workers, work leads, and supervisors to ensure these processes are implemented before work begins.
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1. Berkeley Lab Assessment and Authorization Processes. Berkeley Lab uses the following institutional assessment and authorization processes and documents to define work, identify biological hazards and potential exposures, assess biological risks, and establish biosafety controls:
a. Work Planning and Control (WPC) document is prepared for each worker (see the ES&H Manual Work Planning and Control program)
b. A Subcontractor Job Hazards Analysis (sJHA) and Work Authorization is prepared for each subcontractor, vendor, or affiliate (see the ES&H Manual sJHA Process – Subcontractor Job Hazards Analysis program).
c. WPC Activities are prepared for work with biological materials in specific operations or projects. In the case of research involving biological materials, the Institutional Biosafety Committee (IBC) reviews and approves the definition of work, risk assessment, and controls as part of the authorization process. See Work Process B.2 below for details.
2. Biosafety Risk Assessment Process
a. The institutional assessment and authorization processes and documents noted in Work Process B.1 above incorporate the standard biosafety risk-assessment process defined and required by the CDC, NIH, and DOE in the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), and the Worker Safety and Health Program (WSHP).
b. The standard biosafety risk-assessment process starts with considering three primary factors: (1) the inherent work hazard posed by the biological material or agent, (2) the susceptible hosts (i.e., receptors) that may be affected by the material or agent, and (3) the exposure pathways between the threat hazard and the susceptible host.
c. In addition, BMBL outlines the following five-step approach for laboratory supervisors and work leads to assess biological risk and to select controls for laboratory work:
d. The remaining sections of Work
Process B present in greater detail the key factors underlined above that must
be considered when conducting risk assessments and selecting controls. Primary
factors include material or agent hazards (perceived or real) and procedure
hazards. Secondary factors include staff proficiencies and other personal
factors. See
Section II of BMBL for more information on biological risk assessment.
3. Material or Agent
Hazards and Requirements
a. Biological Materials and Agents. The material or agent hazard(s) and associated requirements must be considered at the start of the risk assessment. Terms used to describe biological materials must also be defined and understood before a risk assessment takes place. This is because these terms often have specific meanings, associated requirements, and associated lists:
b. Material Viability. In addition, the risk assessment should consider the state or treatment of the biological material that may change or eliminate the hazardous characteristics of the material, and this information should be included in the Biosafety Work Authorization when the information significantly describes the safety aspects of the work. For example, biohazardous characteristics of a biological material may not be present if the material is in a nonviable, fixed, inactive, or decontaminated state. These terms are listed below along with simplified definitions and examples:
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Plate A shows microbial growth |
Plate B shows no visible colonies |
The above pictures show sterility certification of a genomic DNA preparation from a sewage-derived culture. Sample viability is determined by plating, incubating, and comparing the culture before gDNA extraction on plate A (positive control) with the gDNA prepared sample on Plate B. Following incubation: (a) Plate A shows a lawn of microbial growth, and (b) plate B shows no visible colonies and confirms sterility of the prepared sample. Source: Harry Beller, LBNL, JBEI (April 2011). Assessment of viability is often a component of the risk assessment and work process and determines biosafety containment level. |
c. Risk Group Classification
Table 2. Risk Group Classification
Risk Group (RG) Level |
Risk Group Definition |
1 |
Agents that are not associated with disease in healthy adult humans |
2 |
Agents that are associated with human disease that is rarely serious, and for which preventive or therapeutic interventions are often available |
3 |
Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) |
4 |
Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) |
Source: Adapted from the NIH Guidelines, Appendix B, Table 1. |
d. Pathogenic Agents and Toxins
Table 3. Pathogenic Agent and Toxin Categories
i. Pathogen and Toxin Information and Guidance
1. Documentation of the hazardous characteristics and controls for well-known pathogens and toxins is usually readily available and should be considered in the risk assessment. This section lists agencies and organizations that provide such information, along with links to the information sources.
2. Because it may be difficult to find information on lesser-known pathogens or toxins, variants of pathogens, or opportunistic pathogens, their use may require additional risk assessments. For example, special technical information might be needed for avirulent or attenuated agents that have been physiologically modified or genetically altered and therefore several-orders-of-magnitude less likely to produce disease in a healthy host organism. In addition, “opportunistic pathogens” may not be listed as pathogens because they may only infect immunocompromised hosts.
a. BMBL Agent Summary Statements. Section III of the BMBL provides summary statements for many agents associated with laboratory-acquired infections or increased public health concern. Risk assessments must consider any information from these agent summary statements that apply to specific Berkeley Lab work activities. Categories included in the agent summary statements are listed below:
b. Pathogen Safety Data Sheets for Infectious Substances. The Public Health Agency of Canada produces and provides pathogen safety data sheets for infectious substances as a safety resource for Canadian laboratory workers who may be exposed to these agents in research, public health, teaching, and other laboratories.
c. CDC Health Information. The CDC A-Z Index provides information on topics with relevance to a broad cross section of CDC audiences. The items are representative of popular topics and frequent inquiries, or have critical importance to the CDC’s public health mission. Topics such as diseases and vaccinations are covered.
1. Human Etiologic Agents (NIH Guidelines). The NIH Guidelines provide a list of human pathogens and their RG2, RG3, and RG4 designations in Appendix B (Classification of Human Etiologic Agents on the Basis of Hazard) of the NIH Guidelines (also see Appendix B of this manual). Work with human pathogens at Berkeley Lab will be conducted in accordance with the agent-specific RG designations in Appendix B of the NIH Guidelines and this Biosafety Program.
2. BMBL Human Pathogens. BMBL agent summary statements contain BL-specific containment guidance for specific human pathogens (see Work Process B.3.i, Pathogen and Toxin Information and Guidance, of this program). Work with human pathogens at Berkeley Lab will be conducted in accordance with the IBC. The IBC will determine the proper containment level for pathogenic work, and use the recommended BL guidance presented in BMBL agent summary statements when available and applicable to the work activity. See Work Process C.4.a of this manual for additional information on BLs.
3. DOE WSHP Biological Etiologic Agents. The DOE WSHP regulation (10 CFR 851, Appendix A, Section 7) has specific requirements for “biological etiologic agents.” Berkeley Lab’s program to comply with 10 CFR 851 defines a biological etiologic agent as an agent of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that causes disease in humans (i.e., is pathogenic to humans). See Appendix B of this manual for the NIH list of human etiologic agents. Work with biological etiologic agents must be documented, reviewed, and authorized as discussed in Work Process D.1.a.ii, WPC Activities, of this program. During and following the review and authorization process, the IBC and EHS Division ensure the implementation of oversight and reporting responsibilities for biological etiologic agents. See Appendix A for specific Berkeley Lab requirements related to biological etiologic agents under 10 CFR 851.
4. Bloodborne Pathogens. See Work Process B.3.f, Bloodborne Pathogens and Human Material, and Appendix C for requirements related to human pathogens that are considered bloodborne pathogens (BBPs) under the Cal/OSHA Bloodborne Pathogens Standard.
5. CDC Select Agents. The Health and Human Services (HHS) CDC regulation on select agents and toxins lists agents that are both select agents and human pathogens. See Work Process B.3.d, Pathogenic Agents and Toxins, for more information.
6. Aerosol Transmissible Pathogens. The Cal/OSHA Aerosol Transmissible Diseases Standard provides a list of Aerosol Transmissible Pathogens/Diseases including pathogens requiring airborne infection isolation and pathogens requiring droplet precautions in Appendix A. See Work Process B.3.i Aerosol Transmissible Pathogens for requirements pertained to non-laboratory work.
7. Aerosol Transmissible Pathogens (Laboratory). The Cal/OSHA Aerosol Transmissible Diseases Standard provides a list of agents that, when reasonably anticipated to be present, require compliance with Section 5199 for laboratory operations in Appendix D. See Work Process B.3.j Aerosol Transmissible Pathogens - Laboratory for requirements for laboratories working with these pathogens.
1. Typical laboratory work with very small quantities of most toxins can be performed with minimal risk to the worker. Toxins do not replicate, are not infectious, and are difficult to transmit mechanically or manually from person to person. Other characteristics that further limit the spread of toxins include the fact that many commonly employed toxins are relatively unstable in the environment (especially in the case of protein toxins) and have very low volatility.
2. Toxins must be handled using the general and “particularly hazardous substance” sections of the Berkeley Lab Chemical Hygiene and Safety Plan (CHSP). In addition, safety and security controls (presented below) based on a risk assessment must be used for each specific laboratory operation. The main laboratory risks are accidental exposure by direct contamination of the mouth, eyes, or other mucous membranes; inadvertent aerosol generation; and needlestick or other accidents that may compromise the normal barrier of the skin.
3. Requirements and guidelines for storage and work with toxins in the laboratory are covered and summarized below. See Work Process B.3.d.v.3, Select Agents and Toxins, for additional information on toxins listed in the National Select Agent Registry.
a. BMBL Guidelines for Work with Toxins. According to Appendix I of BMBL, toxins of biological origin must be reviewed and should be incorporated into work with toxins based on a risk assessment approved by the IBC. Key criteria in the guidelines and Berkeley Lab policies:
b. BMBL Toxin Agent Summary Statements. Section VIII-G of BMBL contains information and guidance on specific toxins. When specific toxins listed in this section of the BMBL are used, this guidance must be reviewed and should be incorporated into the work in accordance with the IBC-approved risk assessment.
1. Select agents and
toxins are specific pathogenic agents and toxins regulated by the HHS-CDC and the
USDA-APHIS due to their potential threat (e.g., as biological weapons) to
human, animal, and plant health. Specific genetic elements, recombinant
nucleic acids, and recombinant organisms that may pose a similar threat are
also regulated. Appendix B, Section B.2, of this manual provides the list of
select agents and toxins and additional toxin information.
2. Possession, use, storage, or transfer of select agents and toxins must be conducted in compliance with the HHS-CDC and USDA-APHIS regulations related to human, plant, and animal select agents and toxins. Specific controls for select agents must be detailed in a Biosafety, Security, and Incident Response Plan for Select Agents. In addition, select agent registrations, transfers, and destructions will be reported to the DOE Berkeley Site Office when and as described in Appendix A. Contact the EHS Biosafety Officer for guidance and assistance. Controls for select agents have also been integrated into the overall Biosafety Program.
3. See the National
Select Agent Registry (NSAR) Program Web site for additional information on select agents provided
by HHS-CDC and USDA-APHIS. The NSAR Program oversees possession of select
agents and toxins for the HHS-CDC Division of Select Agents and Toxins and the
USDA-APHIS Agricultural Select Agent Program.
Normal and diseased (misfolded) prions. Source: ScienceBlogs, Basic Concepts: Prions, by Shelley Batts (February 11, 2007).
1. A prion is an infectious agent composed of protein. All such agents discovered to date propagate by transmitting a misfolded protein; the protein does not itself self-replicate and the process is dependent on the presence of the polypeptide in the host organism. The misfolded form of the prion protein has been implicated in prion diseases known as transmissible spongiform encephalopathies (TSEs). TSEs are neurodegenerative diseases that affect humans and a variety of domestic and wild animal species. Examples are Creutzfeldt-Jakob disease (CJD) in humans and bovine spongiform encephalopathy (BSE), also known as mad cow disease, in cattle. All known prion diseases affect the structure of the brain or other neural tissue, are currently untreatable, and are always fatal.
2. Prion diseases are transmissible by inoculation or ingestion of infected tissue or homogenates. Prion infections usually occur in brain or other central nervous system tissues, and to a lesser extent in lymphoid tissues including spleen, lymph nodes, gut, bone marrow, and blood.
3. Section VIII-H of BMBL provides an agent
summary statement that includes guidelines for prion diseases. When applicable,
this guidance must be used to incorporate controls based on a risk assessment
into the Biosafety Work Authorization.
e. USDA-Regulated Materials, Organisms, and Agents
APHIS |
Examples of USDA-APHIS-Regulated Materials, Organisms, and Agents |
Plant Protection and Quarantine (PPQ) |
Plant pests such as soil, plant pathogens, plants, plant products, weeds, insects, mollusks, and nematodes |
Veterinary Services (VS) |
Material, organisms, vectors, animal pathogens, animal products, cell cultures and their products, live animals, semen, embryos, and veterinary biologics (e.g., vaccines, antibodies, and diagnostic kits) that may harm animal health |
Biotechnology Regulatory Services (BRS) |
Certain genetically engineered organisms that may pose a plant pest risk, including organisms that are plants, insects, or microbes |
Agricultural Select Agent Program |
Animal and plant pathogens that are select agents |
f. Bloodborne Pathogens and Human Materials
BBP materials, including human blood, human tissue, and human cells. Source: Berkeley Lab.
Table 5. Materials Covered by the Cal/OSHA Bloodborne Pathogens Standard*
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* |
Text taken from Cal/OSHA § 5193. Bloodborne Pathogens Standard and the OSHA Standard Interpretation on Applicability of 1910.1030 to Establish Human Cell Lines. |
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** |
Most primary human cell strains and established human cell lines at Berkeley Lab (e.g., American Type Culture Collection cell lines) are OPIM as required by the OSHA Standard Interpretation on such cells. If the researcher does not want to consider the cells OPIM, the cells must be “characterized.” Characterization must include documented screening of the cell lines or strains for viruses specified as BBPs in the OSHA standard, including human immunodeficiency viruses, hepatitis viruses, and herpes viruses (e.g., Epstein-Barr virus) if the cells are capable of propagating such viruses. Documentation that the cell line in culture is free of BBPs must be reviewed and approved by the Biosafety Officer and the Institutional Biosafety Committee. |
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g. Recombinant
Materials, Organisms, and Agents
i. Recombinant Terms, Processes, and Risks
1. Genetic material plays a fundamental role in determining the structure and nature of cell substances. It exists in the nucleus, mitochondria, and cytoplasm of a cell or organism, and is capable of self-propagation and genetic variation. The genetic material of a cell can be a gene, a part of a gene, a group of genes, a deoxyribonucleic acid (DNA) molecule, a fragment of DNA, a group of DNA molecules, or the entire genome of an organism. A nucleic acid is a macromolecule composed of chains of monomeric nucleotides. In biochemistry, nucleic acids carry genetic information or form structures within cells. The most common nucleic acids are DNA and ribonucleic acid (RNA). Nucleic acids are universal in living things, as they are found in all cells and viruses. The term “genetic recombination” is used to describe the process by which the strand of genetic material (usually DNA, but can also be RNA) is broken and then joined to a different DNA molecule to create recombinant genetic material. The NIH Guidelines defines recombinant and synthetic nucleic acid molecules as molecules constructed outside living cells by joining natural or synthetic nucleic acid segments to nucleic acid molecules that can replicate in a living cell or molecules that result from the replication of such molecules.
2. Vectors are commonly used in genetic engineering to create recombinant materials, organisms, agents, or cells. In molecular biology, a vector is a DNA molecule used as a vehicle to transfer foreign genetic material into another cell. Such a vector usually does not cause disease itself, but may change the properties and risks associated with the host cell. The four major types of vectors are plasmids, bacteriophages and other viruses, cosmids, and artificial chromosomes. Two common vectors are plasmids and viral vectors.
a. Plasmid vectors are commonly used to multiply or express particular genes. Many plasmids are commercially available for such uses. Plasmids are DNA segments that are separate from chromosomal DNA and are capable of replicating independently of the chromosomal DNA. In many cases, a plasmid is circular and double-stranded. Plasmids usually occur naturally in bacteria, but are sometimes found in eukaryotic organisms. Plasmids are considered transferable genetic elements, capable of autonomous replication within a suitable host. Plasmid host-to-host transfer requires direct, mechanical transfer by "conjugation" or changes in host gene expression, allowing the intentional uptake of the genetic element by "transformation." Plasmids provide a mechanism for horizontal gene transfer within a population of microbes and typically provide a selective advantage under a given environmental state. For example, plasmids may carry genes that provide resistance to naturally occurring antibiotics in a competitive environmental niche, or alternatively the proteins produced may act as toxins under similar circumstances. If these plasmids are inserted into a different host bacterium, the new host may acquire antibiotic resistance or produce toxic protein.
b. Viral vectors are a viral tool commonly used to deliver genetic material into cells. This process can be performed inside a living organism (in vivo) or in cell culture (in vitro). Viruses have evolved specialized molecular mechanisms to efficiently transport their genomes inside the cells they infect. Delivery of genes by a virus is termed transduction, and the infected cells are described as transduced. Although viral vectors are occasionally created from pathogenic viruses, they are modified in such a way as to minimize the risk of handling them. This usually involves the deletion of a part of the viral genome critical for viral replication. Such a virus can efficiently infect cells, but once the infection has taken place, it requires a helper virus to produce new virions. Examples of recombinant viral vectors include:
c. Transgenic organisms may also be used or created in genetic engineering. A transgenic organism is an organism whose genome has been altered by the transfer of a gene or genes from another species or breed. Examples of transgenic organisms include vertebrates such as mice, plants, and microbes.
d. Recombinant Risks. Work with or the creation of recombinant organisms or specific recombinant genomic materials and nucleic acids may create new risks to humans, animals, plants, or the environment. These potential recombinant risks must be identified and evaluated during the risk-assessment process. Examples of genetic modifications that may increase risk Untitled event include modifications that increase an agent’s pathogenicity or susceptibility to effective treatments (e.g., antibiotics), or increase an organism’s ability to compete in the natural environment.
ii. Recombinant Requirements
1. NIH Requirements. Requirements and specific practices for constructing and handling recombinant DNA molecules, and organisms and viruses containing recombinant DNA molecules, are specified in the NIH Guidelines. The NIH Guidelines have broad requirements for biosafety risk assessment and control similar to BMBL requirements. In addition, the NIH Guidelines have special institutional and line-management requirements such as an Institutional Biosafety Committee (IBC) review process and responsibilities specifically defined for principal investigators (PIs). Institutions such as Berkeley Lab that receive NIH funding are required to comply with the NIH Guidelines. As a condition for NIH funding, Berkeley Lab and lead investigators (e.g., PIs) must ensure that all nonexempt recombinant DNA research experiments conducted at or sponsored by the Berkeley Lab, regardless of the source of funding, comply with the NIH Guidelines. The work review and authorization processes and documents detailed in Work Process D.1.a.i, General Review and Authorization Process, are key tools that assist researchers to comply with the NIH Guidelines.
2. APHIS Requirements. APHIS permits may also be required for the importation, interstate movement, or environmental release of certain genetically engineered organisms that may be plant pests (see Appendix I of this manual).
3. Recombinant
research requires a risk assessment, establishment of containment levels and
controls, and a Biosafety Work Authorization (for more information, see Work
Processes A through E of this manual).
1. Working with
animals in research, caring for animals in animal care facilities, or coming in
contact with animals or vectors in the field may cause zoonotic or other
diseases. A zoonosis or zoonose is an infectious disease that can be
transmitted (in some instances, by a vector) from nonhuman animals, both wild
and domestic, to humans, or from humans to nonhuman animals (the latter is
sometimes called reverse zoonosis). Human diseases caused by a noninfectious,
etiological agent derived from animals or their vectors are not considered a
zoonosis (e.g., allergic reactions to animal products such as dander or urine).
Work involving animals may expose workers to etiologic agents in a variety of
ways such as wound infections, inhalation of aerosols (e.g., dust from animal
bedding), and animal bites or scratches. See Table 6 for examples of zoonotic
diseases and other diseases related to animals.
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Mice, bedding, and allergies. Source: Berkeley Lab EHS. | Aquarium fish and skin infections or gastroenteritis. Source: Wikipedia unrestricted distribution. | Dirt or compost containing feces and tetanus. | Ticks and Lyme disease. Source: Calif. Dept. of Public Health Web site, 2012. |
2. Worker safety, agricultural, and recombinant risks related to working with animals must be evaluated during the risk assessment, and proper containment measures must be employed. See the following sections and standards for additional information:
Table
6. Examples of Zoonotic and Other Diseases Related to Animals
Disease |
Reservoir Vectors |
Causative Agent |
Exposure Routes |
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Inhalation |
Ingestion |
Skin Contact |
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Allergies |
Vertebrate animals |
Animal allergens |
Dander, urine, or saliva in dust or bedding |
— |
— |
Anthrax |
Animals |
Bacillus anthracis |
Contaminated dust with spores |
Contaminated with spores |
Contaminated materials with spores |
Hantavirus pulmonary syndrome |
Rodents/deer mice |
Sin nombre virus |
Contaminated dust from dried urine, saliva, droppings |
— |
— |
Herpes B virus infection |
Nonhuman primates, particularly endemic in rhesus and cynomolgus members of the Macaque genus |
Herpesvirus simiae or |
Aerosolized macaque saliva |
Mucosal splashes (e.g., monkey fluids contact the worker’s eyes or mouth) |
Monkey bites, monkey scratches, or cage scratches; direct contamination of a preexisting wound with macaque saliva; needle-stick injuries following needle use in macaques |
Lyme disease |
Rodents/deer |
Borrelia burgdorferi |
— |
— |
Ixodid tick bite |
Plague |
Rodents/fleas |
Yersinia pestis |
— |
— |
Flea (Xenopsylla cheopis, Pulex irritans) bite |
Q fever |
Sheep, goats, cattle |
Coxiella buretii |
Barnyard dust contaminated by birth material and excreta |
Milk ingestion, regurgitation, and perspiration |
— |
Rabies |
Rabid animals |
Rabies virus |
— |
— |
Bites and saliva from an infected animal |
Rocky Mountain spotted fever |
Ticks |
Rickettsia rickettsii |
— |
— |
Tick bites or skin contact with contaminated materials |
Tetanus |
Animals |
Clostridium tetani |
— |
— |
Wounds contaminated with dirt or objects containing animal or human feces or saliva |
Various diseases such as skin infections or gastro-enteritis |
Fish aquarium water |
Mycobacterium marinum, |
— |
— |
Skin contact with aquarium water, especially if skin has cuts or abrasions |
i. Aerosol Transmissible Pathogens (Non-Laboratory work)
J. Aerosol Transmissible Pathogens - Laboratory (ATP-L)
Berkeley Lab work that involves ATP-L materials will be performed in compliance with the Cal/OSHA Aerosol Transmissible Diseases Standard. Berkeley Lab’s program for compliance with this standard is integrated into the larger Berkeley Lab Biosafety Program that is described in this manual.
4. Laboratory Procedure Hazards
a. The BMBL five-step approach to assessing biological risk and selecting controls for laboratory work was initially presented in Work Process B.2.c of this program. Step 2 (identifying laboratory procedure hazards) of this approach is discussed in this section.
b. Historical data on laboratory acquired infections (LAIs) are an indicator of laboratory procedure hazards that have resulted in disease. As discussed in the BMBL, historical data show that past LAIs have occurred from:
c. See Section II of BMBL for more information
regarding LAIs. Prevention of LAIs depends on the conscientious and proficient
use of standard microbiological practices and special practices (see Work Process C.1) and the correct
use of laboratory equipment. Table 7 below lists examples of hazards that may
be found in laboratories using biological materials.
Table 7. Equipment Hazard Examples
Equipment Type |
Hazards |
Examples |
Aerosol generating |
The diameter of aerosols generated from certain types of equipment will vary from 0.1 to 100 microns.
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Cryogenic temperatures |
Cryogenic temperatures of -80°C are used to remove moisture from materials and contain low-temperature refrigerants. If protective equipment is not used, exposure to low temperature may cause cryogenic burns and frostbite. |
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High temperatures |
The use of heat to decontaminate or sterilize materials is widely used in the biological research laboratory. Physical injury from burns may occur from sudden accidental releases of heat sources or from the handling of hot items. |
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High pressure |
Compressed gas cylinders and pressurized equipment are commonly used in the laboratory. Injury may occur from ruptured high-pressure lines. |
Autoclaves operate at high pressures of 1,000 kilo Pascal (145 psig). |
Oxygen deficiencies |
Low-temperature freezers may include a backup system involving the use of a cryogenic liquid. Backup systems may consist of 50–200 liters of liquid nitrogen or liquid carbon dioxide under pressure. Liquid helium is also used in nuclear magnetic resonance (NMR) laboratories. |
Oxygen deficiency environment may result from:
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Rotational energies |
Sudden release of such rotational energies can cause serious physical injury from unbalanced equipment or flying shrapnel. |
Tabletop and floor-mounted low, high, and ultracentrifuges rotate at speeds ranging from less than 5,000 to more than 100,000 rpm with rotor masses up to several kilograms. |
Sharps |
Any device having corners, edges, or projections capable of cutting or piercing the skin. Berkeley Lab's definition of sharps includes regulated sharps (medical waste), unregulated biohazardous sharps, and unregulated uncontaminated sharps that pose a safety hazard to custodians and other personnel. |
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Ultraviolet (UV) C radiation |
UVC radiation is used for inactivating microorganisms. Its usefulness, however, is limited by a variety of factors (e.g., low penetrating power). The eyes and skin can be damaged by exposure to direct or strongly reflected UV radiation. |
UV lights must be evaluated to determine whether the benefits outweigh the potential hazards. UV radiation is sometimes used in conjunction with:
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5. Worker Competence and Health
a. General. The BMBL five-step approach to assessing biological risk and selecting controls for laboratory work was initially presented in Work Process B.2.c of this program. Step 4 of this approach (i.e., the evaluation of a worker’s proficiencies or competence) and the evaluation of a worker’s health are discussed in this section. Step 4 is an ongoing process in which the supervisor or work lead evaluates a worker’s training, instructions, qualifications, behavior, and health. Worker training and health requirements are also a component of the Biosafety Work Authorization.
b. Workers are the first line of defense for protecting themselves, others in the laboratory, and the public from exposure to biohazardous agents. Laboratory staff must therefore be properly trained, instructed, and qualified before conducting work. Supervisors and work leads should train and evaluate staff to the point where knowledge of the agent and procedure hazards, aseptic techniques, safety practices, use of safety equipment, caution, and attentiveness become second nature. Knowledge and experience prior to job assignment may also be necessary qualifications. See Work Process D.2, Training, Instruction, and Qualification, for more information on training, instruction, and qualification.
c. In addition, a worker’s health status may affect his or her susceptibility to an infection or ability to receive immunizations or prophylactic intervention. Workers who know they have an illness or medical condition that affects their immune system or their ability to receive vaccines or medications should seek an evaluation by Health Services in Building 26. See Work Process D.3, Occupational Health and Immunization, for additional information regarding worker health and immunization.
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