Appendix B to Part 626 - Glossary Abbreviations

AMC—United States Army Materiel Command AR—Army regulation ARSTAF—Army Staff ASA (IL&E)—Assistant Secretary of the Army (Installations, Logistics and Environment) ASA (RDA)—Assistant Secretary of the Army (Research, Development, and Acquisition) BDP—Biological Defense Program BL—Biosafety level CG—commanding general CSA—Chief of Staff, United States Army DA—Department of the Army DA Pam—Department of the Army Pamphlet DASAF—Director of Army Safety DCSOPS—Deputy Chief of Staff for Operations and Plans DOD—Department of Defense HEPA—high efficiency particulate air HQDA—Headquarters, Department of Army IPR—in process reviews MACOM—major Army command MCA—Military Construction, Army MCE—maximum credible event OCSA—Office of the Chief of Staff, United States Army R&D—research and development RDTE—research, development, test, and evaluation RCRA—Resource Conservation Recovery Act SOP—standing operating procedure TSG—The Surgeon General, Army USACE—United States Army Corps of Engineers USAMRDC—United States Army Medical, Research and Development Command Terms Biological Defense Mishap

An event in which the failure of laboratory facilities, equipment, or procedures appropriate to the level of potential pathogenicity or toxicity of a given etiologic agent (organism or toxin) may allow the unintentional, potential exposure of humans or the laboratory environment to that agent. Mishaps can be categorized into those resulting in confirmed exposures and those resulting in potential exposures. A confirmed accidental exposure is any mishap in which there was direct evidence of an exposure, such as a measurable rise in specific antibody titer to the etiologic agent in question, or a confirmed diagnosis of intoxication or disease. A potential exposure is any mishap in which there was reason to believe that anyone working with an etiologic agent may have been exposed to that agent, yet no measurable rise in specific antibody titer or diagnosis of illness or disease can be found. However, there is reason to believe in such a case that the possibility existed for introduction of an etiologic agent through mucous membranes, the respiratory tract, broken skin, or the circulatory system as a direct result of the incident or injury.

Biocontainment Area

An area which meets the requirements for a BL-3 or BL-4 facility. The area may be an entire building, a suite of rooms, a single room within a building, or a biological safety cabinet.

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 sub-classes of class II cabinets. Each type of cabinet provides a different degree of protection to personnel and to the products handled inside them.

Biosafety Level

A combination of facilities, equipment, and procedures used in handling etiologic agents to protect the worker, environment, and the community. This combination is proportional to the potential hazard of the etiologic agent in question.

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, 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. Personnel must be trained. Strict adherence to recommended practices is as important in attaining the maximum containment capability as is the mechanical performance of the equipment itself.

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 there is potential 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, or by other physical containment 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 commander, (4) the facility is either in a separate building or in a controlled area within a building, which is 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 levels.

Confirmed Exposure

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

Decontamination

The physical or chemical processes by which an object or area, contaminated with a harmful or potentially harmful etiologic agent, is made safe for handling or use. Such processes include physical removal of all contaminants, thermal destruction of biological activity (sterilization), chemical inactivation (biocidal process), or a combination of these methods.

Etiologic Agent

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

Exemption

A permanent written exemption approved by HQDA for a requirement imposed by this regulation. An exemption is based on a determination that conformity to the established standard is impossible, highly impracticable, unnecessary, or not in the best interest of the United States Government.

First Aid

Any one-time treatment, and any follow-up visit for the purpose of observation of minor scratches, cuts, burns, splinters, and so forth, which do not ordinarily require medical care. Such one-time treatment, and follow-up visit for observation, is considered first aid, even through provided by a physician or registered medical professional personnel.

High efficiency particulate air (HEPA) filter

A filter which removes particulate matter down to sub-micron sized particles from the air passed through it with a minimum efficiency of 99.97 percent. HEPA filters remove particulate matter with great efficiency while vapors and gases (for example from volatile chemicals) are not removed and pass through unrestricted. HEPA filters are used as the primary means of removing infectious agents from air exhausted from engineering controls and facilities.

Institute Director

The commander 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, or similar facility) 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 provides space in which work with etiologic agents may be performed. It contains all of the appropriate engineering features and equipment required at a given biosafety level to protect personnel working in the laboratory and the environment external to the facility.

Potential Accidental Exposure

Any mishap in which there was reason to believe that anyone working with a BDP material may have been exposed to that material, 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, ingestion, respiratory tract, broken skin, or circulatory system as a direct result of the accident, injury, or incident.

Resource Conservation Recovery Act (RCRA) Listed Hazardous Waste

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

Sterilization

The complete destruction of all forms of microbial life.

Suite

An area consisting of more than one room, and designed to be a functional unit in which laboratory operations can be conducted. Suites may contain a combination of laboratories and animal holding rooms or both 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 biologic origin that has been isolated from the parent organism. The toxic material of plants, animals, or microorganisms.

Waiver

A temporary (1 year or less) written relief from a requirement imposed by this regulation, pending accomplishment of actions or programs which will result in conformance to the required standards. Waivers will not be extended beyond 5 years.