Chapter 26

BIOSAFETY

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26.6 Definitions

Term

Definition

Adeno-associated virus (AAV)

A virus that infects humans and some other primate species. AAV is a very attractive candidate for creating viral vectors because it is not known to cause disease in humans, can infect both dividing and nondividing cells, and may incorporate its genome into that of the host cell.

American Biological Safety Association (ABSA

A professional association that promotes biosafety as a scientific discipline and serves the growing needs of biosafety professionals throughout the world

Animal and Plant Health Inspection Service (APHIS

An agency of the USDA responsible for protecting and promoting U.S. agricultural health, administering the Animal Welfare Act, and carrying out wildlife damage management activities

Animal Biosafety Level (BL-N)

A standard containment and confinement practice for research involving whole animals when (1) recombinant research involves larger animals (e.g., nonhuman primates), (2) animals are infected with human pathogens, or (3) animals may harbor zoonotic agents (see this manual for details)

Animal Welfare and Research Committee (AWRC

A Berkeley Lab committee that reviews and approves proposed Berkeley Lab research for animal welfare concerns. Federal law uses the term Institutional Animal Care and Use Committee (IACUC).

Antimicrobial 

A chemical or physical agent used in the decontamination process to prevent microbial growth

Antisepsis 

The application of a liquid antimicrobial chemical to human or animal living tissue to prevent sepsis

Antiseptic 

A disinfecting chemical agent applied to living tissue and used to prevent sepsis

Australia Group (AG) 

An informal forum of countries that, through the harmonization of export controls, seeks to ensure that exports do not contribute to the development of chemical or biological weapons

Autoclave

A piece of equipment with a chamber that is 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

Biohazard

A biological material or condition that presents potential detrimental risk to the health of humans or other organisms, either directly through infection or indirectly through damage to the environment

Biohazard label 

A sign that is predominantly fluorescent orange or orange-red and contains a biohazard symbol and the word “Biohazard” in a contrasting color

Biohazardous

An adjective used to describe biological materials that present potential detrimental risk to the health of humans or other organisms, either directly through infection or indirectly through damage to the environment

Biohazardous waste

Waste that requires inactivation (i.e., decontamination) in an approved manner prior to disposal, but is not regulated by the California Department of Health Services as regulated medical waste. See PUB-3095Medical and Biohazardous Waste Generator Guidelines, for additional information.

Biological agent or agent

A very specific biological organism or material often directly responsible for producing an effect (e.g., disease). Agent examples include a microorganism (e.g., bacterium, fungus, or parasite), virus, prion, or biological toxin.

Biological etiologic agent

An agent of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that causes disease in humans (i.e., is pathogenic to humans)

Biological materials 

A broad range of organisms, cells, viruses, and other materials of biological origin that pose differing levels of risks to plants, animals, or humans

Biological products 

Materials regulated by the Department of Transportation (DOT) and the International Air Transport Association (IATA) for shipping that are derived from living organisms and manufactured for use in the prevention, diagnosis, treatment, or cure of disease in humans or animals and are certified by the USDA, Food and Drug Administration (FDA), or other national authority. Examples of biological products include certain viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, and blood products.

Biological toxin, biotoxin, or toxin.

See toxin.

Biological Use Application 

The form completed by a prinicipal investigator (PI) or supervisor and submitted to the EHS biosafety office for review, approval, and authorization by a Biosafety Officer, the IBC, or line management. Authorized applications result in a BUA, BUR, or BUN.

Biological Use Authorization (BUA) 

A type of Berkeley Lab formal biosafety authorization for work involving Risk Group (RG) 2 or higher biological materials, Biosafety Level (BL) 2 used for safety, or a regulatory permit or registration

Biological Use Notification (BUN) 

A type of Berkeley Lab biosafety authorization for work involving RG1 biological materials, including work with NIH-exempt recombinant DNA molecules

Biological Use Registration (BUR) 

A type of Berkeley Lab biosafety authorization for work involving RG1 work with recombinant DNA molecules and organisms or viruses containing recombinant DNA molecules

Biological Weapons Convention (BWC)

A multilateral disarmament treaty that prohibits the development, production, acquisition, transfer, retention, stockpiling, and use of biological and toxin weapons and is a key element in the international community’s efforts to address the proliferation of weapons of mass destruction

Biosafety or biological safety 

The general administrative and physical safety measures and efforts employed in a certain environment (e.g., Berkeley Lab) to protect workers, the public, agriculture, and the environment from exposure to biological agents or materials that may cause disease or other detrimental effects in humans, plants, or animals

Biosafety Authorization System (BAS

The Berkeley Lab online system used to manage and provide BUNs, BURs, BUAs, and related information

Biosafety cabinet or biological safety cabinet (BSC) 

A hood with high-efficiency particulate air (HEPA) filters that is designed to provide personnel, environmental, and/or product protection when appropriate practices and procedures are followed

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

The title of an NIH-CDC national code of practice and Berkeley Lab standard for biosafety that outlines and defines biosafety risk assessment and control

Biosafety Level (BL) 

A standard combination of practices and techniques, safety equipment, and facilities to safely contain biohazardous materials or agents to be used in work, as specified by BMBL and the NIH Guidelines. The NIH Guidelines uses the acronym BL, and BMBL uses the acronym BSL. The term biosafety level and acronym BL may be used generally to apply to any work with biological materials, but the acronym BL when used without additional letters or words technically applies only to laboratory BLs. When other letters or words are added to the BL acronym, other containment categories are indicated (e.g., BL-Large Scale, BL-P for plants, and BL-N for animals).

Biosafety Officer 

A person in the EHS Division who oversees the development and maintenance of the primary structure and function of the Biosafety Program in accordance with the biosafety standards

Biosafety Program

ES&H Manual Biosafety Program (Chapter 26). A comprehensive Berkeley Lab program document that covers fundamental principles of biosafety, integrates requirements from the biosafety standards, and provides direction on identifying biological risks and required controls

Biosafety Work Authorization 

A BUA, BUR, BUN, or ECP

Biosecurity 

The administrative and physical security measures used to protect higher-consequence microbial agents or toxins and related information from loss, theft, diversion, or intentional misuse

Biotechnology Regulatory Services (BRS)

A branch of APHIS that regulates the introduction (importation, interstate movement, or environmental release) of certain genetically engineered organisms that may pose a plant pest risk, including organisms that are plants, insects, or microbes

Blood 

As used in the OSHA Bloodborne Pathogens Standard, means human blood, human blood components, and products made from human blood

Bloodborne pathogen (BBP) material

A term used at Berkeley Lab to describe biological agents or materials that are covered by the OSHA Bloodborne Pathogens Standard including, for example, bloodborne pathogens, human blood, human blood components, products made from human blood, and other potentially infectious materials (OPIM)

Bloodborne pathogens (BBPs) 

Infectious agents such as the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV) that are capable of causing human disease and are transmitted through human blood

Bovine spongiform encephalopathy (BSE) 

A fatal neurodegenerative disease in cattle caused by a prion infection. BSE causes the animal’s brain and spinal cord to degenerate, and is characterized by the spongy appearance of infected brain tissue. BSE — also known as mad cow disease — is a type of transmissible spongiform encephalopathy. Humans who ingest brain or spinal cord tissue from infected cattle carcasses may develop a TSE known as new variant or variant Creutzfeldt-Jakob disease (nvCJD or vCJD).

Bureau of Industry and Security (BIS)

An agency of the U.S. Department of Commerce that deals with issues involving national security and high technology. The BIS is responsible for implementing and enforcing the Export Administration Regulations (EAR) and has a principal goal of stopping proliferation of weapons of mass destruction, while furthering the growth of U.S. exports.

California Department of Food and Agriculture (CDFA) 

An agency in the California state government responsible for ensuring the state’s food safety, the protection of the state’s agriculture from invasive species, and promoting the state’s agricultural industry

Category A Infectious Substances 

See Infectious Substances, Category A.

Category B Infectious Substances 

See Infectious Substances, Category B.

Center for Veterinary Biologics (CVB

A group within APHIS Veterinary Services (VS) that regulates veterinary biologics including vaccines, antibodies, diagnostic kits, and certain immunomodulators, including those developed using genetically engineered organisms 

Centers for Disease Control and Prevention (CDC

One of the 13 major operating components of the U.S. Department of Health and Human Services

Chemical Safety Hygiene Plan (CHSP)

A comprehensive Berkeley Lab policy and tool that provides requirements and guidance to employees on the safe handling, use, and storage of hazardous materials such as chemicals and engineered nanomaterials in laboratory, shop, and office settings

Commerce Control List (CCL

A section of the EAR that lists specific goods, technologies, and software and the countries to which those items may or may not be exported, along with any special restrictions or exceptions that may apply

Common carrier 

A person or company that transports goods or people for any person or company and that is responsible for any possible loss of the goods during transport (e.g., FedEx or UPS)

Containment 

A set of controls including the safe methods, equipment, and facilities needed to protect workers and the environment from biohazardous materials or agents

Contaminated 

The potential presence of biohazardous material on an item or surface. The OSHA Bloodborne Pathogens Standard defines contaminated as the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

Corrective Action Tracking System (CATS

An online Berkeley Lab database tool used to identify, track, and resolve issues and their associated corrective actions as well as determine the effectiveness of those corrective actions

Creutzfeldt-Jakob disease (CJD) 

An incurable neurodegenerative and fatal human disease caused by a prion infection. CJD causes brain nerve cells to degenerate and is characterized by the spongy appearance of infected brain tissue. Although CJD is rare, it is the most common type of transmissible spongiform encephalopathy in humans. Three major categories of CJD are sporadic CJD, hereditary CJD, and acquired CJD.

Customs and Border Protection (CBP)

A federal law-enforcement agency of the U.S. Department of Homeland Security charged with regulating and facilitating international trade, collecting import duties, and enforcing U.S. regulations including trade (e.g., import and export), drugs, and immigration

Dangerous Goods Regulations (DGR)

A manual published by IATA to provide procedures for shippers and operators by which articles and substances with hazardous properties can be safely and efficiently transported by air on all commercial air transport. The manual provides lists and classifications of articles and substances (e.g., infectious substances) and requirements for training, packing, labeling, documentation, handling, and reporting.

Decontamination

The process of reducing or inactivating biological contaminants or components to an acceptable level to reduce or eliminate the possibility of transmission of pathogens to undesired hosts such as laboratory workers, the general public, and other organisms in the environment

Deoxyribonucleic acid (DNA)

A nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms and some viruses.

Department of Energy (DOE)

A Cabinet-level department of the U.S. government concerned with the U.S. policies regarding energy and safety in handling nuclear material. DOE also sponsors basic and applied scientific research mostly through its system of U.S. DOE national laboratories such as Berkeley Lab.

Department of Transportation (DOT)

A federal Cabinet-level department of the U.S. government concerned with interstate transportation and keeping the traveling public safe and secure, increasing their mobility, and having a transportation system that contributes to the nation's economic growth

Detergent

A synthetic surfactant

Disease

Any deviation from or interruption of the normal structure or function of any body part, organ, or system that is manifested by a characteristic set of symptoms and signs and whose etiology, pathology, and prognosis may be known or unknown

Disinfectant

A chemical germicide or physical agent applied to inanimate objects to kill microbes, but that is not capable of killing endospores, some viruses, or mycobacterium. Disinfectants are typically chemical germicides.

Disinfection

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. Common laboratory disinfectants include diluted household bleach or 70% isopropanol.

Dust mask

A common but inaccurate name for a filtering facepiece respirator

Emergency eyewash

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, so as to prevent injury to the eye and exposed body surfaces or penetration of an agent into the body

Emergency eyewash and shower

A combined plumbing unit(s) designed to properly flush chemical, biological, or other hazardous agents off of the skin or the face, and out of mucous membranes such as the eyes, so as to prevent injury to the exposed body surfaces or penetration of an agent into the body

Emergency Guide

An online Berkeley Lab guide and wall-mountable flip chart that covers worker instructions and telephone numbers for reporting incidents and general emergency response for a variety of common emergencies including biological spills and personal injury

Environment/Health/Safety (EHS) Division at Berkeley Lab

Manages environment, safety, and health programs to ensure Berkeley Lab fulfills its requirements

Environment, Safety, and Health (ES&H) 

A term used to describe subjects (e.g., policies, responsibilities, and functions) related to protecting the safety and health of workers, the public, and the environment

Environmental Protection Agency (EPA)

An agency of the U.S. government charged to protect human health and the environment that has primary responsibility for setting and enforcing national standards under a variety of environmental laws. The EPA also conducts environmental assessment, research, and education and works with industry and government in voluntary pollution-prevention and energy-conservation efforts.

Etiologic

An adjective that means disease-causing

Export Administration Regulations (EAR)

Regulations that contain the CCL and are issued by the U.S. Department of Commerce BIS under laws relating to the control of certain exports, re-exports, and activities

Exposure Control Plan (ECP) 

A Berkeley Lab authorization document that defines work, hazards, and controls in accordance with the requirements of the OSHA Bloodborne Pathogens Standard for work with or potential exposure to BBP materials. The BUA is the ECP for work that pertains to research.

Eye protection

A safety device such as safety glasses or goggles worn over the eyes to prevent injury to the eye or exposure to biological agents

Face mask

A loose-fitting, disposable device that covers the worker’s nose and mouth and is not a respirator (e.g., products labeled as surgical, medical, dental, or isolation masks)

Face protection

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

Filtering facepiece respirator

A negative-pressure, air-purifying respirator with a particulate filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium. A filtering facepiece respirator is sometimes poorly referred to as a “dust mask” or improperly called an “N95 respirator.”

Fixed

A biological material that has been treated so that it has been stabilized and preserved in place. Fixing cells with some fixatives (e.g., paraformaldehyde or glutaraldehyde) kills the cells and most potential pathogens.

Food and Drug Administration (FDA

An agency of the U.S. Health and Human Services Department responsible for protecting and promoting public health through the regulation of food safety, tobacco products, dietary supplements, medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products, cosmetics, and other concerns

Foot protection 

An enclosed shoe or safety shoe worn on the foot to protect the foot from injury or exposure to biological agents

Genetic material 

Material found in the nucleus, mitochondria, and cytoplasm of a cell or organism. It plays a fundamental role in determining the structure and nature of cell substances and is capable of self-propagating and variation. The genetic material of a cell can be a gene, a part of a gene, a group of genes, a DNA molecule, a fragment of DNA, a group of DNA molecules, or the entire genome of an organism.

Genetic recombination 

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

Genetically modified organisms (GMOs) or microorganisms (GMMOs) 

Organisms and microorganisms, regulated by DOT and IATA for shipping, in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally

Germicide 

An antimicrobial substance or physical agent that kills microbes

Good microbiological practice (GMP) 

Aseptic techniques and other GMPs necessary to prevent contamination of the laboratory with agents being handled and to prevent contamination of the work with agents from the environment

Greenhouse

A structure with walls, a roof, and a floor designed and used principally for growing plants in a controlled and protected environment

Greenhouse facility

The actual greenhouse rooms or compartments for growing plants and all immediately contiguous hallways and head-house (i.e., work) areas, considered part of the confinement area

Guidelines

A set of nonmandatory but desirable criteria, conditions, or best management practices that should typically be considered when determining controls needed to mitigate risk

Hand protection

A glove or other safety device used on the hand to prevent injury to the hand or direct skin contact with biological materials

Handwashing facility

A facility that is required when work is conducted with BBP materials. It has an adequate supply of running potable water, soap, and single-use towels or hot-air drying machines.

Handwashing sink

A basin with running water and a drain, designed for washing hands. It should be provided with a soap dispenser and paper towel dispenser as a best management practice.

Hazardous Material Regulations (HMR)

DOT regulations that govern the movement of hazardous materials (e.g., infectious substances) in vehicles, airplanes, railcars, or vessels via public right-of-ways such as roadways, airways, railways, and sea lanes that are accessible to the public

Health and Human Services (HHS)

A Cabinet department of the U.S. government that contains the U.S. Public Health Service and has the goal of protecting the health of all Americans and providing essential human services

Hepatitis B virus (HBV)

A pathogen that causes contagious liver disease (i.e., hepatitis B) in humans. HBV is a common BBP.

Hepatitis C virus (HCV)

A pathogen that causes contagious liver disease (i.e., hepatitis C) in humans. HCV is a common BBP.

High-efficiency particulate air (HEPA) filter

A device composed of fibrous materials capable of trapping and retaining at least 99.97% of airborne monodispersed particles 0.3 micrometers (µm) in diameter

Hood

An enclosure or shaped inlet designed to conduct contaminated air into an exhaust duct system, or a filter that safely captures the contaminant

Household bleach

A water-based solution of sodium hypochlorite with a typical concentration of 5.25% by weight of the active sodium hypochlorite ingredient

Human immunodeficiency virus (HIV)

A lentivirus (a member of the retrovirus family) that causes acquired immunodeficiency syndrome (AIDS), a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections. HIV is a common BBP.

Human pathogen

(or infectious agent)

An infectious microbe (e.g., bacterium, protozoon, fungus, virus, etc.) or other agent (e.g., prion) that causes disease in healthy humans

Human Subjects Committee (HSC)

A Berkeley Lab committee that reviews proposed research projects involving human subjects, human-derived data, or human-derived tissues for ethical concerns in accordance with HHS regulations and DOE orders

Inactive

A biological material incapable of acting or reacting normally

Infectious agent

(or human pathogen)

An infectious microbial (e.g., bacterium, protozoon, fungus, virus, etc.) or other agent (e.g., prion) that causes disease in healthy humans

Infectious substances

Materials regulated by DOT and IATA for shipping that are known to be, or are reasonably suspected to contain, an animal or human pathogen. A pathogen is a virus, microorganism (including bacteria, plasmids, or other genetic elements), proteinaceous infectious particle (prions), or recombinant microorganism (hybrid or mutant) known or reasonably expected to cause disease in humans or animals.

Infectious substances, Category A

Materials regulated for shipping by DOT and IATA that are capable of causing permanent disability, or life threatening or fatal disease in humans or animals, when exposure to them occurs

Infectious substances, Category B

Materials regulated for shipping by DOT and IATA that are infectious, but do not meet the standard for inclusion in Category A

Institutional Biosafety Committee (IBC)

A Berkeley Lab committee that provides oversight, administration, and review of Laboratory policies and projects involving research with biological materials that may pose safety, health, or environmental risks

Institutional Review Board (IRB)

An HHS-mandated committee that requires the use of established principles and requirements during the ethical review of proposed research projects involving human subjects, human-derived data, or human-derived tissues. The IRB for Berkeley Lab is the HSC.

Integrated Pest Management (IPM)

A term used in the BMBL and Berkeley Lab biosafety policy to describe a comprehensive program approach that integrates housekeeping, maintenance, and pest-control services to prevent pest problems by managing the facility environment to make it less conducive to pest infestation

Integrated Safety Management (ISM

The safety management system used by Berkeley Lab and DOE to systematically integrate safety into management and work practices at all levels so that missions are accomplished while protecting the public, the worker, and the environment

International Air Transport Association (IATA)

An international industry trade group of airlines that represents, leads, and serves the airline industry and publishes the DGR used for airlines’ shipping of articles and substances with hazardous properties including infectious substances.

International Traffic in Arms Regulations (ITAR)

A set of U.S. Department of State regulations that control the export and import of defense-related articles and services on the U.S. Munitions List (USML).

Iodophor 

A preparation containing iodine complexed with a solubilizing agent, such as a surfactant or povidone (a type of water-soluble polyvinyl polymer)

Ionizing radiation 

Radiation of sufficiently high energy to cause ionization in the medium through which it passes

Job Hazards Analysis (JHA)

The Berkeley Lab process that results in a worker hazard and control description (Hazards Profile) and Work Authorization prepared for a specific worker according to the requirements of the ES&H Manual Job Hazards Analysis program.

Laboratory acquired infections (LAIs)

All infections acquired through laboratory or laboratory-related activities regardless of whether they are symptomatic or asymptomatic in nature

Laboratory Biosafety Level (BL)

A standard combination of practices and techniques, safety equipment, and facilities to safely contain biohazardous materials or agents used in laboratory work

Large Scale (BL–Large Scale)

A term used in the NIH Guidelines and Berkeley Lab biosafety policy to describe uses of and containment levels for organisms containing recombinant DNA molecules involving a quantity of culture greater than 10 liters

Lawrence Berkeley National Laboratory (LBNL)

Also called Berkeley Lab. A DOE national laboratory that conducts unclassified, interdisciplinary scientific research.

Medical waste

Waste generated or produced as a result of the following: diagnosis, treatment, or immunization of human beings or animals; research pertaining to the diagnosis, treatment, or immunization of human beings or animals; or the production or testing of biologicals. See PUB-3095, Medical and Biohazardous Waste Generator’s Guide, for additional information.

Medical/biohazardous waste 

Wastes that are biological materials or contaminated with biological materials and that require inactivation (i.e., decontamination) in an approved manner prior to final disposal

Must

The condition is required.

N95 respirator 

A term sometimes improperly used to describe a filtering facepiece respirator that has a 95% efficient filter built into the facepiece

National Center for Import Export (NCIE

A group within APHIS VS that regulates the import, export, and interstate movement of all animals and animal products (e.g., tissues, blood, and semen), including those that are genetically engineered

National Institutes of Health (NIH)

One of eight health agencies that are components of the Public Health Service (PHS)

National Select Agent Registry (NSAR) 

A cooperative program between the USDA-APHIS Agricultural Select Agent Program and the CDC Division of Select Agents and Toxins to oversee activities involving the possession of biological agents and toxins that have the potential to pose a severe threat to public health, animal or plant health, or to animal or plant products

Negative-pressure air-purifying cartridge respirator 

A respirator that uses a filter, sorbent, or catalyst housed inside a cartridge to remove contaminants from the air (e.g., respirators using an N95 or P100 cartridge particulate filter that is 95% or 100% efficient, respectively)

Negative-pressure air-purifying respirator 

A tight-fitting respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator and an air-purifying filter or cartridge removes specific air contaminants (e.g., filtering facepiece and some cartridge respirators)

NIH Guidelines 

An abbreviated title used by NIH for the document titled  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules .

Nonviable 

A biological material or agent incapable of living or developing under favorable conditions

Nucleic acid

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 RNA.

Occupational Safety and Health Administration (OSHA)

An agency of the U.S. government that ensures the safety and health of U.S. workers (e.g., by setting and enforcing standards)

Occurrence Reporting and Processing System (ORPS) 

A Berkeley Lab system that is used to notify and keep Laboratory management and applicable elements of DOE informed of abnormal occurrences that could adversely affect (1) the health and safety of employees, guests, visitors, and the general public; (2) the environment; (3) the intended purpose of Berkeley Lab facilities; or (4) the credibility of DOE and/or Berkeley Lab

Office of Laboratory Animal Welfare (OLAW)

An office of NIH that oversees compliance with the PHS Policy on Humane Care and Use of Laboratory Animals

Organism 

Any living system (such as animal, plant, fungus, or microorganism). In at least some form, all organisms are capable of response to stimuli, reproduction, growth and development, and maintenance of homeostasis as a stable whole. An organism may either be unicellular (single-celled) or composed of, as in humans, many billions of cells grouped into specialized tissues and organs. The term “multicellular” (many-celled) describes any organism made up of more than one cell.

Other Potentially Infectious Materials (OPIM) 

Materials other than blood and bloodborne pathogens that are regulated by the OSHA Bloodborne Pathogens Standard based on their potential to contain BBPs. See Table 5 of this manual and definitions for blood and bloodborne pathogens.

Parenteral 

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

Pathogen 

An infectious microbe (e.g., bacterium, protozoon, fungus, virus, etc.) or other agent that causes disease in healthy host organisms such as humans, animals, or plants

Patient specimens or diagnostic specimens 

Any human or animal materials including but not limited to excreta, secreta, blood, blood components, tissue, and tissue fluids being shipped for the purpose of diagnosis and regulated by DOT and IATA

Personal protective equipment (PPE)

Clothing or equipment worn by workers to protect the body from injury by hazardous agents or materials. Examples of PPE include foot, hand, eye, face, body, and respiratory protection. PPE is one element of biosafety containment.

Plant Biosafety Level (BL-P) 

Standard physical and biological containment conditions and practices suitable to greenhouse operations that conduct experiments involving plants, plant-associated microorganisms, and small animals (e.g., arthropods or nematodes)

Plant Protection and Quarantine (PPQ)

 A branch of APHIS that safeguards agriculture and natural resources from the risks associated with the entry, establishment, or spread of animal and plant pests and noxious weeds to ensure an abundant, high-quality, and varied food supply

Plasmids 

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.

Positive-pressure respirator 

A respirator designed to maintain positive pressure inside the facepiece during exhalation and inhalation (e.g., a powered air-purifying respirator or PAPR)

Potable water or drinking water 

Water that is satisfactory for drinking, culinary, and domestic purposes and meets the requirements of the regulatory health authority having jurisdiction. In laboratory and other industrial water uses, the building’s water supply is separated through backflow prevention devices in the building’s plumbing system into potable and industrial water systems or sources.

Povidone-iodine (PVP-I) 

An iodophor antimicrobial composed of a stable chemical complex of polyvinylpyrrolidone (povidone or PVP) and elemental iodine (ranging from 9.0% to 12.0% available iodine, calculated on a dry basis)

Principal investigator (PI)

The individual assigned authority and responsibility to direct a research experiment, project, or program that is typically funded by a grant

Prion 

An infectious agent composed of protein that typically propagates by transmitting a misfolded protein state

Program self-assessment

One component of the Berkeley Lab Self-Assessment Program that is managed by the EHS Division. The ES&H biosafety self-assessment program reviews biosafety programs and processes Laboratory-wide to ensure they comply with guiding regulations, are effective, and are properly implemented by Laboratory divisions.

Protective laboratory clothing 

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

PUB-3000 

The Berkeley Lab ES&H Manual

Public Health Service (PHS)

An umbrella organization in the U.S. federal government consisting of eight HHS health agencies, the Office of Public Health and Science, and the Commissioned Corps (a uniformed service of health professionals). NIH and CDC are agencies within the PHS.

Quaternary ammonium compound (quat) 

A cationic detergent compound derived from ammonia by replacing the hydrogen atoms with organic radicals. It is especially important for use in surface-active agents, disinfectants, or drugs.

Recombinant or synthetic nucleic acid molecules 

Defined by the NIH Guidelines 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

Recombinant genetic (or genomic) materials 

Genetic materials that have undergone genetic recombination. See definitions for genetic materials and genetic recombination.

Respirator 

A device such as a filtering facepiece or negative-pressure cartridge respirator designed and certified to protect the wearer from the inhalation of harmful atmospheres

Respiratory protection

A control such as a biosafety cabinet, enclosed containment system, or respirator that prevents worker inhalation of an agent to harmful levels

Responsible official (RO)

A Berkeley Lab person who has the authority and responsibility to ensure compliance with CDC and USDA regulations for possession, use, or transfer of select agents and toxins, as specified in the regulations and on behalf of Berkeley Lab

Ribonucleic acid (RNA)

A biologically important type of molecule that consists of a long chain of nucleotide units. Each nucleotide consists of a nitrogenous base, a ribose sugar, and a phosphate. RNA is very similar to DNA, but differs in a few important structural details. For example, in the cell, RNA is usually single-stranded, while DNA is usually double-stranded.

Risk group (RG)

A system adopted by the CDC and NIH for classifying biological agents by the degree of human hazard. There are four risk groups, and a higher RG number indicates a higher level of hazard.

Safety-engineered sharps or safety-engineered needles

Sharp tools with a built-in safety feature or mechanism that effectively reduces the risk of accidental skin penetration and biological exposure incident. Examples include devices that blunt, sheath, or withdraw the sharp when the sharp edge or point has been used or is not in use. Also see below Sharps with ESIP.

Sanitization

The process of generally reducing, but not necessarily eliminating, microbes from the inanimate environment to levels considered safe by public health standards

Select agents and toxins 

(1) Specific pathogenic agents and toxins listed and strictly regulated by the CDC and USDA (i.e., under 7 CFR 331, 9 CFR 121, and 42 CFR 73) because they may be used as agents of mass destruction or pose a severe threat to human, animal, and plant health; and (2) specific genetic elements, recombinant nucleic acids, and recombinant organisms related to the list of select agents and toxins as described in the regulations

Sepsis 

The presence of infectious organisms in the blood or other tissue of the body

Sharp

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.

Sharps with engineered sharps injury protection (ESIP)

Defined in the OSHA Bloodborne Pathogen Standard as a non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident

Should 

An expectation that the condition will be met unless there is a compelling and countervailing reason for not meeting the condition and the alternative provides a sufficient level of safety that does not conflict with other requirements. When the term “should” is used in a section identified as a guideline, the condition is desirable or is a best management practice, and the condition or other alternatives should be implemented when needed to control apparent risk.

Soap 

Sodium or potassium salt of fatty acids

Soil

As defined by the USDA PPQ, a mixture of inorganic and organic materials, in which the organic materials are unidentifiable plant and/or animal parts. The PPQ Soil Circular defines what is and is not soil.

Standard facilities 

Design features, materials, and equipment incorporated into the laboratory or facility in accordance with BL containment criteria stated in BMBL and the NIH Guidelines

Standard microbiological practices and special practices 

Administrative controls listed as BL containment criteria in BMBL and the NIH Guidelines to protect workers and the environment

Standard safety equipment and PPE 

Equipment controls listed as BL containment criteria in BMBL and the NIH Guidelines that provide primary barriers to prevent worker exposure to infectious agents

Standards

The external rules established by government, contract, and funding regulations and nonregulatory standards that form the requirements of the Berkeley Lab Biosafety Program

Sterilant 

An antimicrobial chemical or physical agent capable of killing all microbes, including their spores. It fulfills the sterility assurance level.

Sterile 

Completely free of all living microorganisms and viruses

Sterility assurance level

The degree of killing efficacy in a sterilization process equal to the probability of a microorganism or virus surviving on the item of less than 1 in 1 million

Sterilization 

The process of completely destroying or eliminating all living microorganisms and viruses on an object. Common sterilization methods include autoclaving and incineration.

Sterilization procedure

A treatment process to which an item is subjected after which the probability of a microorganism or virus (including a high number of bacterial endospores) surviving on the item is less than 1 in 1 million. This level of killing efficacy is referred to as the sterility assurance level.

Subcontractor Job Hazards Analysis and Work Authorization (SJHAWA)

The Berkeley Lab work authorization document that identifies work hazards and controls for subcontractors, vendors, and guests

Supervisor Accident Analysis Report (SAAR)

The Berkeley Lab report that a supervisor must complete to document the nature, cause, and necessary actions related to an employee injury

Surfactant 

surface active agent that is usually an organic compound possessing both hydrophilic (water-loving) and lipophilic (fat-loving) properties that make the compound soluble in water and lipids

 

 

Toxin, biological toxin, or biotoxin

 A poisonous substance produced by a living organism. The term “toxin” is used in this manual.

Transgenic organism 

An organism whose genome has been altered by the transfer of a gene or genes from another species or breed

Transmissible spongiform encephalopathies (TSEs)

Neurodegenerative diseases such as Creutzfeldt-Jakob disease (CJD) in humans and bovine spongiform encephalopathy (BSE or "mad cow disease") that affect humans and a variety of domestic and wild animal species

Transportation Authorization Form (TAF) 

A Berkeley Lab form that is (1) generated when Berkeley Lab Transportation is asked via the Facilities Division Work Request Center to move an item, and then (2) completed by the requester and affixed to the item prior to movement to indicate that the item is safe and ready for movement

Ultraviolet (UV) radiation or UV light

Electromagnetic radiation with a wavelength shorter than that of visible light, but longer than X-rays, in the range of 10 nanometers (nm) to 400 nm, and energies from 3 electron volts (eV) to 124 eV

United States Department of Agriculture (USDA)

An agency of the U.S. government with the following types of mission areas: farm and foreign agriculture, food, food safety, nutrition, natural resources, environment, research, education, economics, and rural development

United States Munitions List (USML)

A list of articles, services, and related technology designated as defense-related that are defined in ITAR and fall under the export and temporary import jurisdiction of the Department of State

Veterinary Services (VS)

A branch of APHIS that protects and improves the health, quality, and marketability of the nation's animals, animal products, and veterinary biologics by preventing, controlling and/or eliminating animal diseases, and monitoring and promoting animal health and productivity

Viral vector

A viral tool commonly used to deliver genetic material into cells

Virus

A small infectious agent that can only replicate inside the cells of another organism

Worker Safety and Health Program (WSHP)

A DOE rule (10 CFR 851) that establishes the framework for DOE’s nonradiological worker safety and health programs just as OSHA does for private industry

World Health Organization (WHO)

An agency of the United Nations that specializes in the attainment by all peoples of the highest possible level of health

Zoonosis or zoonose

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). Zoonotic is an adjective that pertains to zoonosis.

 

 

 

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