Laboratory-associated infections are extremely rare. Two have been documented. Both resulted from presumed exposure to high titered infectious aerosols, one generated in a vaccine production facility(65) and the other in a research facility.(66) Naturally or experimentally infected animals, their tissues, and their excretions are a potential source of exposure for laboratory and animal care personnel.

Laboratory Hazards: The agent may be present in all tissues of infected animals. Highest titers are present in CNS tissue, salivary glands, and saliva. Accidental parenteral inoculation, cuts, or sticks with contaminated laboratory equipment, bites by infected animals, and exposure of mucous membranes or broken skin to infectious tissue or fluids, are the most likely sources for exposure of laboratory and animal care personnel. Infectious aerosols have not been a demonstrated hazard to personnel working with clinical materials and conducting diagnostic examinations. Fixed and attenuated strains of virus are presumed to be less hazardous, but the only two recorded cases of laboratory associated rabies resulted from exposure to a fixed Challenge Virus Standard (CVS) and an attenuated strain derived from SAD (Street Alabama Dufferin) strain, respectively. (67)(68)

Recommended Precautions: Biosafety Level 2 practices and facilities are recommended for all activities utilizing known or potentially infectious materials. Immunization is recommended for all individuals prior to working with rabies virus or infected animals, or engaging in diagnostic, production, or research activities with rabies virus. Immunization is also recommended for all individuals entering or working in the same room where rabies virus or infected animals are used. While it is not always feasible to open the skull or remove the brain of an infected animal within a biological safety cabinet, it is pertinent to wear heavy protective gloves to avoid cuts or sticks from cutting instruments or bone fragments, and to wear a face shield to protect the mucous membranes of the eyes, nose, and mouth from exposure to infectious droplets or tissue fragments. If a Stryker saw is used to open the skull, avoid contacting the brain with the blade of the saw. Additional primary containment and personnel precautions, such as those described for Biosafety Level 3, may be indicated for activities with a high potential for droplet or aerosol production, and for activities involving production quantities or concentrations of infectious materials.

Transfer of Agent: For a permit to import thi agent, contact CDC.

Data on occupational HIV transmission in laboratory workers are collected through two CDC-supported national surveillance systems: surveillance for 1) AIDS and 2) HIV-infected persons who may have acquired their infection through occupational exposures. For surveillance purposes, laboratory workers are defined as those persons, including students and trainees, who have worked in a clinical or HIV laboratory setting anytime since 1978. Cases reported in these two systems are classified as either documented or possible occupational transmission. Those classified as documented occupational transmission had evidence of HIV seroconversion (a negative HIV-antibody test at the time of the exposure which converted to positive) following a discrete percutaneous or mucocutaneous occupational exposure to blood, body fluids, or other clinical or laboratory specimens. As of June 1998, CDC had reports of 16 laboratory workers (all clinical) in the United States with documented occupational transmission.(69)

In 1992, two workers in different laboratories were reported to have developed antibodies to simian immunodeficiency virus (SIV) following exposures. One was associated with a needle stick which occurred while the worker was manipulating a blood-contaminated needle after bleeding an SIV-infected macaque monkey.(70) The other involved a laboratory worker who handled macaque SIV-infected blood specimens without gloves. Though no specific incident was recalled, this worker had dermatitis on the forearms and hands while working with the infected blood specimens.(71) The first worker seroconverted and has no evidence of persistent SIV infection. The second worker has been seropositive for at least nine years with no evidence of illness or immunological incompetence.

Recent publications(72)(73) have identified the prevalence (4/231, 1.8%) of infection with simian foamy viruses (SFV) among humans occupationally exposed to nonhuman primates. Evidence of SFV infections included seropositivity, proviral DNA detection, and isolation of foamy virus. The infecting SFV originated from an African green monkey (one person) and baboons (three people). These infections have not as yet resulted in either disease or sexual transmission, and may represent benign endpoint infections.

Laboratory Hazards: HIV has been isolated from blood, semen, saliva, tears, urine, cerebrospinal fluid, amniotic fluid, breast milk, cervical secretion, and tissue of infected persons and experimentally infected nonhuman primates.(74) CDC has recommended that blood and body fluid precautions be used consistently when handling any blood-contaminated specimens.(75)(76) This approach, referred to as "universal precautions," precludes the need to identify clinical specimens obtained from HIV-positive patients or to speculate as to the HIV status of a specimen.

Although the risk of occupationally acquired HIV is primarily through exposure to infected blood, it is also prudent to wear gloves when manipulating other body fluids such as feces, saliva, urine, tears, sweat, vomitus, and human breast milk. This also reduces the potential for exposure to other microorganisms that may cause other types of infections.

In the laboratory, virus should be presumed to be present in all blood or clinical specimens contaminated with blood, in any unfixed tissue or organ (other than intact skin) from a human (living or dead), in HIV cultures, in all materials derived from HIV cultures, and in/on all equipment and devices coming into direct contact with any of these materials.

SIV has been isolated from blood, cerebrospinal fluid, and a variety of tissues of infected nonhuman primates. Limited data exist on the concentration of virus in semen, saliva, cervical secretions, urine, breast milk, and amniotic fluid. In the laboratory, virus should be presumed to be present in all SIV cultures, in animals experimentally infected or inoculated with SIV, in all materials derived from HIV or SIV cultures, and in/on all equipment and devices coming into direct contact with any of these materials.(77)

In the laboratory, the skin (especially when scratches, cuts, abrasions, dermatitis, or other lesions are present) and mucous membranes of the eye, nose, and mouth should be considered as potential pathways for entry of these retroviruses. Whether infection can occur via the respiratory tract is unknown. The need for using sharps in the laboratory should be evaluated. Needles, sharp instruments, broken glass, and other sharp objects must be carefully handled and properly discarded. Care must be taken to avoid spilling and splashing infected cell-culture liquid and other virus-containing or potentially infected materials.(78)

Recommended Precautions: In addition to the following recommended precautions, persons working with HIV, SIV, or other bloodborne pathogens should consult the OSHA Bloodborne Pathogen Standard.(79) Questions related to interpretation of this Standard should be directed to Federal, regional or state OSHA offices.

1. BSL-2 standard and special practices, containment equipment and facilities are recommended for activities involving all blood-contaminated clinical specimens, body fluids and tissues from all humans, or from HIV- or SIV-infected or inoculated laboratory animals.

2. Activities such as producing research-laboratory-scale quantities of HIV or SIV, manipulating concentrated virus preparations, and conducting procedures that may produce droplets or aerosols, are performed in a BSL-2 facility, but using the additional practices and containment equipment recommended for BSL-3.

3. Activities involving industrial-scale volumes or preparation of concentrated HIV or SIV are conducted in a BSL-3 facility, using BSL-3 practices and containment equipment.

4. Nonhuman primates or other animals infected with HIV or SIV are housed in ABSL-2 facilities using ABSL-2 special practices and containment equipment.

Additional Comments:

1. There is no evidence that laboratory clothing poses a risk for retrovirus transmission; however, clothing that becomes contaminated with HIV or SIV should be decontaminated before being laundered or discarded. Laboratory personnel must remove laboratory clothing before going to non-laboratory areas.

2. Work surfaces are decontaminated with an appropriate chemical germicide after procedures are completed, when surfaces are overtly contaminated, and at the end of each work day. Many commercially available chemical disinfectants (80)(81)(82)(83)(84) can be used for decontaminating laboratory work surfaces and some laboratory instruments, for spot cleaning of contaminated laboratory clothing, and for spills of infectious materials. Prompt decontamination of spills should be standard practice.

3. Human serum from any source that is used as a control or reagent in a test procedure should be handled at BSL-2.

4. It is recommended that all institutions establish written policies regarding the management of laboratory exposure to HIV and SIV in conjunction with applicable federal, state and local laws. Such policies should consider confidentiality, consent for testing, administration of appropriate prophylactic drug therapy,(85) counseling, and other related issues. If a laboratory worker has a parenteral or mucous-membrane exposure to blood, body fluid, or viral-culture material, the source material should be identified and, if possible, tested for the presence of virus. If the source material is positive for HIV antibody, virus, or antigen, or is not available for examination, the worker should be counseled regarding the risk of infection and should be evaluated clinically and serologically for evidence of HIV infection. Post-exposure prophylaxis should be offered according to the latest guidelines. The worker should be advised to report and seek medical evaluation of any acute febrile illness that occurs within 12 weeks after the exposure.(86) Such an illness ­ particularly one characterized by fever, rash, or lymphadenopathy ­ may indicate recent HIV infection. If the initial (at time of exposure) test is negative, the worker should be retested 6 weeks after the exposure and periodically thereafter (i.e., at 12 weeks and 6, 9 and 12 months after exposure). During this follow-up period exposed workers should be counseled to follow Public Health Service recommendations for preventing transmission of HIV. (87)(88)(89)(90)(91)

5. Other primary and opportunistic pathogenic agents may be present in the body fluids and tissues of persons infected with HIV. Laboratory workers should follow accepted biosafety practices to ensure maximum protection against inadvertent laboratory exposure to agents that may also be present in clinical specimens or in specimens obtained from nonhuman primates.(92)(93)(94)

Research involving other human (i.e., human T-lymphotrophic virus types I and II) and simian retroviruses occurs in many laboratories. Recently, surveillance for such infections revealed occupational exposure and infection by simian foamy virus among animal caretakers at laboratory research facilities.(95)(96) The precautions outlined above are sufficient while working with these agents.

Laboratory work with retroviral vectors, especially those containing full-length infectious molecular genomes (HIV-1), should be handled in BSL-2 facilities under BSL-2/3 practice. This includes infectious clones derived from nonhuman viruses, but possessing xenotropic (especially for human cells) host ranges.

Transfer of Agent: For a permit to import these agents, contact CDC.

Laboratory-associated infections with the transmissible spongiform encephalopathies (prion diseases) have not been documented. However, there is evidence that Creutzfeldt-Jakob disease (CJD) has been transmitted iatrogenically to patients by corneal transplants, dura mater grafts and growth hormone extracted from human pituitary glands, and by exposure to contaminated electroencephalographic electrodes.(97) Infection is always fatal. There is no known nonhuman reservoir for CJD or kuru. Nonhuman primates and other laboratory animals have been infected by inoculation, but there is no evidence of secondary transmission. Scrapie of sheep and goats, bovine spongiform encephalopathy and mink encephalopathy are transmissible spongiform encephalopathies of animals that are similar to the human transmissible diseases. However, there is no evidence that the animal diseases can be transmitted to man. (See also Section VII-D, Prions.)

Laboratory Hazards: High titers of a transmissible agent have been demonstrated in the brain and spinal cord of persons with kuru. In persons with Creutzfeldt-Jakob disease and its Gerstmann-Sträussler-Schenker Syndrome variants, a similar transmissible agent has been demonstrated in the brain, spleen, liver, lymph nodes, lungs, spinal cord, kidneys, cornea and lens, and in spinal fluid and blood. Accidental parenteral inoculation, especially of nerve tissues, including formalin-fixed specimens, is extremely hazardous. Although non-nerve tissues are less often infectious, all tissues of humans and animals infected with these agents should be considered potentially hazardous. The risk of infection from aerosols, droplets, and exposure to intact skin, gastric and mucous membranes is not known; however, there is no evidence of contact or aerosol transmission. These agents are characterized by extreme resistance to conventional inactivation procedures including irradiation, boiling, dry heat and chemicals (formalin, betapropiolactone, alcohols); however, they are inactivated by 1 N NaOH, sodium hypochlorite (2% free chlorine concentration) and steam autoclaving at 132^oC for 4.5 hours.

Recommended Precautions: Biosafety Level 2 practices and facilities are recommended for all activities utilizing known or potentially infectious tissues and fluids from naturally infected humans and from experimentally infected animals. Extreme care must be taken to avoid accidental autoinoculation or other traumatic parenteral inoculations of infectious tissues and fluids.(98) Although there is no evidence to suggest that aerosol transmission occurs in the natural disease, it is prudent to avoid the generation of aerosols or droplets during the manipulation of tissues or fluids, and during the necropsy of experimental animals. It is further strongly recommended that gloves be worn for activities that provide the opportunity for skin contact with infectious tissues and fluids. Formaldehyde-fixed and paraffin-embedded tissues, especially of the brain, remain infectious. It is recommended that formalin-fixed tissues from suspected cases of transmissible encephalopathy be immersed in 96% formic acid for 30 minutes before histopathologic processing.(99) Vaccines are not available for use in humans.(100)

Transfer of Agent: For a permit to import these agents, contact CDC. An importation or domestic transfer permit for Bovine spongiform encephalopathy can be obtained from USDA/APHIS/VS.

A number of laboratory-associated infections with indigenous strains of VSV have been reported.(101) Laboratory activities with such strains present two different levels of risk to laboratory personnel and are related, at least in part, to the passage history of the strains utilized. Activities utilizing infected livestock, their infected tissues, and virulent isolates from these sources are a demonstrated hazard to laboratory and animal care personnel.(102)(103) Rates of seroconversion and clinical illness in personnel working with these materials are high.(104) Similar risks may be associated with exotic strains such as Piry.(105)

In contrast, anecdotal information indicates that activities with less virulent laboratory-adapted strains (e.g., Indiana, San Juan and Glascow) are rarely associated with seroconversion or illness. Such strains are commonly used by molecular biologists, often in large volumes and high concentrations, under conditions of minimal or no primary containment. Some strains of VSV are considered restricted organisms by USDA regulations (9CFR 122.2). Experimentally infected mice have not been a documented source of human infection.

Laboratory Hazards: The agent may be present in vesicular fluid, tissues, and blood of infected animals and in blood and throat secretions of infected humans. Exposure to infectious aerosols, infected droplets, direct skin and mucous membrane contact with infectious tissues and fluids, and accidental autoinoculation, are the primary laboratory hazards associated with virulent isolates. Accidental parenteral inoculation and exposure to infectious aerosols represent potential risks to personnel working with less virulent laboratory-adapted strains.

Recommended Precautions: Biosafety Level 3 practices and facilities are recommended for activities involving the use or manipulation of infected tissues and virulent isolates from naturally or experimentally infected livestock. Gloves and respiratory protection are recommended for the necropsy and handling of infected animals. Biosafety Level 2 practices and facilities are recommended for act ivities utilizing laboratory-adapted strains of demonstrated low virulence. Vaccines are not available for use in humans.

Transfer of Agent: Contact the Department of Commerce for a permit to export this agent. An importation or domestic transfer permit for this agent can be obtained from USDA/APHIS/VS.

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