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5. Risk Assessment: Evaluating Risks to Human Health and Safety
Pages 68-82

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From page 68...
... Risk assessments typically require that attention be given first to the most important hazards, that is, the ones that can result in the worst health-related outcomes. Successful risk assessment offers many advantages.
From page 69...
... THE PROCESS OF RISK ASSESSMENT The process of risk assessment, as used by US regulatory agencies charged with protecting workers and the general public, involves four sequential steps (NRC 1983; Samet and Burke 1998~: hazard identification, dose-response assessment, exposure assessment, and risk estimation and characterization. Multiple sources of data may be used to complete each step, including on-site review and investigation, epidemiologic investigation, surveillance, laboratory animal studies, and computer modeling (see Table 5-1~.
From page 70...
... 70 OCCUPATIONAL HEALTH AND SAFETY OF NONHUMAN PRIMATES TABLE 5-1 Assessment of Risk Associated with Animal-Related Research Possible Criterion Classifications Information Sources Exposure intensity High Job profile, environmental Medium health and safety Low assessment, employee history Absent Exposure frequency 8 h/wk or more Job profile, environmental Less than 8 h/wk health and safety No direct contact assessment, employee history Hazards posed by Severe illness Institutional veterinarian, animals Moderate illness physician Mild illness Illness unlikely Hazards posed by Severe illness Material-safety data sheets; materials used in Moderate illness CDC-NIH agent summary or with animals Mild illness statements; radiation-, Illness unlikely chemical-, and biological safety committees; environmental health and safety staff; direct observation, principal investigator Susceptibility of employee Direct threats Permanent increase Temporary increase Medical evaluation, review of personal medical records Expected incidence High Published reports, industry Medium experience Low History of occupational Common Worker-compensation reports, illness or injury in the Uncommon OSHA 200 log position or workplace Rare /exceptional Regulatory requirements Required Environmental health and safety Professional office, consultants, risk judgment permitted managers aReasonable probability of substantial harm. Americans with Disabilities Act of 1990 (PL 101-336)
From page 71...
... . This report will identify common research themes in contemporary neuroscience and behavioral research based on input from neuroscience and behavioral researchers most familiar with current standards of practice and veterinarian specialists in laboratory animal medicine; provide collective, professional judgment in applying current animal care and best use practices to procedures in these areas of research; provide information about new scientific and responsible use developments used to maintain animals during these experiments; and serve as an informational resource to assist researchers, laboratory animal medicine veterinarians and IACUC members in the interpretation and implementation of current standards of practice and promote the training of animal care specialists in this area.
From page 72...
... If the existence of a hazard cannot be definitively shown in the first step in the risk assessment process, the subsequent steps generally are not warranted. A review of worker exposure and injury reports suggests that most workplace hazards found in nonhuman-primate research facilities are similar to those found in other laboratory animal research environments (bin Zakaria and others 1996; Poole and others 1998, 1999~.
From page 73...
... This step estimates the exposure or contact between a hazard and a person (NRC 1983~. Exposure assessment must take into account numerous modes of possible contact, such as splashes, bites, aerosols, and needle sticks.
From page 74...
... General principles of safety as they pertain to each hazard should be understood, including essential aspects of the laboratory, husbandry, and veterinary equipment in use; facility design elements, such as the systems for air handling and waste decontamination and disposal; systems of employee hygiene and medical surveillance; and how all these are integrated into the OHSP. Persons responsible for risk assessment must also have an appreciation of the flow of the typical workday activities of animal care, facility maintenance, and research as performed by the different members of the staff (and, if applicable, students and visitors)
From page 75...
... Incidence rate = average number of people at risk for event For example, the incidence of needle stick accidents among veterinary staff involved in the care of nonhuman primates should use as the denominator the size of the veterinary workforce involved in venipuncture tasks in nonhuman primates at the institution. Incidence rates are useful whether the purpose is to compare trends as new safety-related equipment and policies are established in an institution or to compare the experience of different sites or institutions.
From page 76...
... The following elements may be evaluated when assessing the risk of infectious hazards in the conduct of laboratory animal work: animal contact, exposure intensity, exposure frequency, physical and biologic hazards present by the animals, hazardous properties of agents used in research protocols, susceptibility of employees, and occupational-health history of employees doing similar work (NRC 1997~. Exposure intensity measures the estimated dose received among those exposed over some arbitrarily defined unit of time, whereas exposure frequency concerns the number of opportunities for any degree of exposure during the same period.
From page 77...
... · Route of transmission · Availability of data from animal studies · Availability of effective prophylaxis or therapy · Experience and skill of personnel at risk Selection of the appropriate ABSL for activities involving infectious material in nonhuman-primate research should be based on evaluation of these criteria, with modifications as needed in light of current scientific information. Answers to questions about the characteristics listed above often are not definitive, especially for newly described infectious agents and materials that contain recombinant DNA; in such cases, the riskassessment process should include an institutional biosafety committee (NIH 1998~.
From page 80...
... In all research involving the use of nonhuman primates, the study director or principal investigator must work with the IACUC, the biosafety officer, and the primate center director to assess risks and set ABSLs in the context of the institutional administrative structure; ultimate authority rests with the senior institutional official (CDC-NIH 1999~. RISK OF OCCUPATIONAL INJURIES AND EXPOSURES AT NATIONAL PRIMATE RESEARCH CENTERS Physical Hazard Risk Assessment An epidemiologic investigation of work-related injuries and exposures among animal care, veterinary, and scientific staff at a US regional primate research center provided yearly estimates of incidence rates ranging from 44 to 65 animal-associated injuries per 100,000 pwd during the 5year period of observation (bin Zakaria and others 1996~.
From page 81...
... In a study involving a questionnaire-based survey of 550 persons working at 13 North American research institutions (Sotir and others 1997) , a high frequency of needle sticks and mucocutaneous exposures
From page 82...
... Over onethird of study participants were reported to have experienced needle sticks or mucocutaneous exposures while working with nonhuman primates, predominantly macaques but including at least six other genera. The study included serial serologic testing for SIV antibodies among study participants and considered whether there was exposure to SIV in the laboratory or to SIV-infected animals.


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