Appendix G to Part 627 - Glossary

Abbreviations AIHA American Industrial Hygiene Association AMC United States Army Materiel Command ANSI American National Standards Institute AR Army Regulation ATCC American Type Culture Collection ASHRAE American Society of Heating, Refrigerating, and Air Condition Engineers, Inc. BDP Biological Defense Program BL biosafety level CDC Centers for Disease Control CFR Code of Federal Regulations DA PAM Department of Army Pamphlet DHEW Department of Health, Education, and Welfare DOD Department of Defense DOT Department of Transportation DNA deoxyribonucleic acid EPA Environmental Protection Agency EtO ethylene oxide FDA Food and Drug Administration fpm feet per minute HEPA high efficiency particulate air HHS Health and Human Services IATA International Air Transport Association IBC Institutional Biosafety Committee ICAO International Civil Aviation Organization lfpm linear feet per minute LS large-scale m meter min minute MSDS Material Safety Data Sheets MSHA Mine Safety and Health Administration NCCLS National Committee for Clinical Laboratory Standards NCI National Cancer Institute NEPA National Environmental Policy Act NFPA National Fire Protection Association NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health NRC Nuclear Regulatory Commission NSF National Sanitation Foundation OSHA Occupational Safety and Health Administration pH the negative logarithm of hydrogen ion concentration PHS Public Health Service PPE personal protective equipment ppm parts per million psi pounds per square inch RCRA-Listed Resource Conservation Recovery Act of 1976 Listed Hazardous Waste RDTE research, development, test, and evaluation RPO Radiation Protection Officer SALS Subcommittee on Arbovirus Laboratory Safety SAR supplied-air respirator SCBA self-contained breathing apparatus SOP Standing Operating Procedure TD to deliver TLV threshold limit value USDA United States Department of Agriculture UV ultraviolet Terms Approved respiratory protection

Equipment which is tested and listed as satisfactory according to standards established by a competent authority (such as NIOSH, Mine Safety and Health Administration (MSHA), or host country agency) to provide respiratory protection against the particular hazard for which it is designed. For military agent protection, DA and Department of Defense (DOD) are the approval authorities. (Approval authority may be specified by law.)

Biocontainment area

An area which meets the requirements for a BL-3 or BL-4 facility.

The area may be an entire building or a single room within a building. See subpart G for details. Biological Safety Cabinets

Engineering controls designed to enable laboratory workers to handle infectious etiologic agents and to provide primary containment of any resultant aerosol. There are three major classes of cabinets (I, II, and III) and several subclasses of class II cabinets. Each type of cabinet provides a different degree of protection to personnel and to the products handled inside them. The various classes of cabinets are described in detail in subpart H.

Biosafety Level 1

The facilities, equipment, and procedures suitable for work involving agents of no known or of minimal potential hazard to laboratory personnel and the environment.

Biosafety Level 2

The facilities, equipment, and procedures applicable to clinical, diagnostic, or teaching laboratories, and suitable for work involving indigenous agents of moderate potential hazard to personnel and the environment. It differs from BL-1 in that (1) laboratory personnel have specific training in handling pathogenic agents, (2) the laboratory is directed by scientists with experience in the handling of specific agents, (3) access to the laboratory is limited when work is being conducted, and (4) certain procedures in which infectious aerosols could be created are conducted in biological safety cabinets or other physical containment equipment.

Biosafety Level 3

The facilities, equipment, and procedures applicable to clinical, diagnostic, research, or production facilities in which work is performed with indigenous or exotic agents where potential exists for infection by aerosol, and the disease may have serious or lethal consequences. It differs from BL-2 in that (1) more extensive training in handling pathogenic and potentially lethal agents is necessary for laboratory personnel; (2) all procedures involving the manipulation of infectious material are conducted within biological safety cabinets, other physical containment devices, or by personnel wearing appropriate personal protective clothing and devices; (3) the laboratory has special engineering and design features, including access zones, sealed penetrations, and directional airflow; and (4) any modification of BL-3 recommendations must be made only by the commander.

Biosafety Level 4

The facilities, equipment, and procedures required for work with dangerous and exotic agents which pose a high individual risk of life-threatening disease. It differs from BL-3 in that (1) members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agents; (2) laboratory personnel understand the primary and secondary containment functions of the standard and special practices, containment equipment, and laboratory design characteristics; (3) access to the laboratory is strictly controlled by the institute director; (4) the facility is either in a separate building or in a controlled area within a building, completely isolated from all other areas of the building; (5) a specific facility operations manual is prepared or adopted; (6) within work areas of the facility, all activities are confined to Class III biological safety cabinets or Class I or Class II biological safety cabinets used in conjunction with one-piece positive pressure personnel suits ventilated by a life support system; and (7) the maximum containment laboratory has special engineering and design features to prevent microorganisms from being disseminated to the environment.

Building

A structure that contains the requisite components necessary to support a facility that is designed according to the required biosafety level. The building can contain one or more facilities conforming to one or more biosafety level.

Confirmed Exposure

Any mishap with a BDP agent in which there was direct evidence of an actual exposure such as a measurable rise in antibody titer to the agent or a confirmed diagnosis of intoxication or disease.

Etiologic Agents

Any viable microorganism, or its toxin which causes or may cause human disease, including those agents listed in 42 CFR 72.3 of the Department of Health and Human Services regulations, and any agent of biological origin that poses a degree of hazard similar to those agents.

Facility

An area within a building that provides appropriate protective barriers for persons working in the facility and the environment external to the facility, and outside of the building.

HEPA Filter

A filter which removes particulate matter down to submicron sized particles from the air passed through it with a minimum efficiency of 99.97 percent. While the filters remove particulate matter with great efficiency, vapors and gases (for example, from volatile chemicals) are passed through without restriction. HEPA filters are used as the primary means of removing infectious agents from air exhausted from engineering controls and facilities.

Human Lethal Dose

The estimated quantity of a toxin that is a minimum lethal dose for a 70 kilogram individual based upon published data or upon estimates extrapolated from animal toxicity data.

Commander or Institute Director

The commander or institute director of an Army activity conducting RDTE with BDP etiologic agents, or the equivalent, at a research organization under contract to the BDP.

Institution

An organization such as an Army RDTE activity (institute, agency, center, and so forth) or a contract organization such as a school of medicine, or research institute that conducts RDTE with BDP etiologic agents.

Laboratory

An individual room or rooms within a facility that provide space in which work with etiologic agents can be performed. It contains all of the appropriate engineering features and equipment required at a given biosafety level to protect personnel working in it and the environment external to the facility.

Large-Scale Operations

Research or production involving viable etiologic agents in quantities greater than 10 liters of culture.

Maximum Containment Area

An area which meets the requirements for a BL-4 facility. The area may be an entire building or a single room within the building. See chapter 7 for details.

Molded Masks

Formed masks that fit snugly around the mouth and nose and are designed to protect against a nontoxic nuisance level of dusts and powders. These do not require approval by NIOSH or MSHA. Masks made of gauze do not qualify.

Potential Accidental Exposure

Any accident in which there was reason to believe that anyone working with a BDP agent may have been exposed to that agent, yet no measurable rise in antibody titer or diagnosis of intoxication or disease was made. However, the high probability existed for introduction of an agent through mucous membranes, respiratory tract, broken skin, or the circulatory system as a direct result of the accident, injury, or incident.

Resource Conservation Recovery Act of 1976 Listed Hazardous Waste

The waste materials listed by the Environmental Protection Agency under authority of the RCRA for which the agency regulates disposal. A description and listing of these wastes is located in 40 CFR part 261.

Suite

An area consisting of more than one room, designed to be a functional unit in which entire operations can be facilitated. Suites may contain a combination of laboratories or animal holding rooms and associated support areas within a facility that are designed to conform to a particular biosafety level. There may be one or more suites within a facility.

Toxin

Toxic material of etiologic origin that has been isolated from the parent organism.1