Understanding, Assessing, and Communicating Topics Related to Risk in Biomedical Research Facilities

Barbara Johnson, PhD, RBP

This paper appears in the ABSA publication,
Anthology of Biosafety IV - Issues in Public Health


Due to the timely nature of its content, ABSA, the editor, and the authors have agreed to release it to the public.

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Introduction
This chapter will discuss and review a spectrum of topics related to risk assessment which include: factors considered in determining biosafety levels (BSL) or risk groups of biological agents, objective and subjective considerations related to risk, and risk communication at the worker, institute, and community level. The first portion of the chapter is dedicated primarily to the assessment of risk as it applies to the laboratorian. As the chapter progresses the emphasis shifts to understanding the components of risk assessment and communication from the perspective of concerned community members. Determining the acceptability of risk involves personal, societal, economic, and scientific values and information (Songer, 1986). General subjective factors to be considered include determining to what extent exposure is viewed as acceptable (ethical, political, legal), and objective factors include evaluating existing data regarding infection (prospective exposure history, infectious dose, severity of disease, and treatment). Additional considerations which are not obvious when assessing and preparing to communicate risk include identifying whether the acceptance of risk is viewed as being a voluntary or involuntary (imposed) action, and recognizing that certain factors contribute to the impression of the lack of risk (lack of knowledge of the organism, long latency period, lack of models to obtain data) (Rayburn, 1990). Ultimately, the careful assessment and communication of risk is one of the underpinnings of a successful biosafety program and a safe and efficient research environment.

Risk Assessment and Communication Responsibilities
At the programmatic level it is the role of the senior management (i.e., Director) to ensure that risk is appropriately and effectively assessed and communicated. The communication effort may extend beyond the worker, the institute, the campus, and to the community. Providing current and relevant information to these individuals is vitally important in planning the construction of a new facility, conducting extensive renovations, or changing the mission and research programs in an existing facility.

Parts of this role may, and often are, delegated to the Biosafety Officer (BSO). It is the role of the BSO to thoroughly identify and communicate elements of risk posed by the research project. Optimally this assessment is conducted in consultation with the senior scientist and technicians proposing and performing the work. This type of proactive approach is usually well received by researchers, as it identifies potential riskspotential risks and provides mitigative procedures and equipment options before the work has begun. In addition to providing detailed technical information to the BSO, and playing an interactive role in the development of the risk assessment, the senior scientist (as well as the BSO) is responsible for ensuring the workforce understands the risks associated with the tasks and methods for mitigating the risks.

This is one model in the delegation of responsibility for assessing and communicating risk. Different organizations will have variations on its implementation. What is important and should be incorporated into all models is the need for interactive relationships and overlap in responsibility among the principal players. The Principles are the Director or Program Manager, the BSO, and the senior scientist. Depending on the nature of the risk, available professional assets, and Institute policy, team, team members may be expanded to include the occupational health staff, industrial hygienist, radiological safety officer, veterinarian, public affairs officer, etc. Some members of the team will play a predominantly technical role in the assessment process, while others will have an overarching role in the process, which may include risk communication. The team which is developed will vary depending on the situation, but the core team should be fairly consistent at the programmatic level to maintain continuity.

Definitions
Risk has been defined as "a probability "(Songer, 1986) or "a chance occurrence"(Rayburn, 1990). Risk is typically associated with connotations of hazard and adverse outcome.

Biological Risk associated with laboratory, chemical, and epidemiologic fieldwork can be defined as the probability of exposure occurring and resulting in an adverse effect. Adverse effects are associated with personnel exposure and events which may affect the activities of a program. Occupational exposure often results in an investigation to determine the cause of the exposure and identify mitigative processes to prevent future exposure and improve worker safety. During the investigative period there may be some disruption of the normal work routine.

Risk-Benefit Analysis is the consideration and weighing of the objective and subjective risks, and the ability to mitigate those risks against the benefit derived from conducting work in lieu of the remaining risk. Simply phrased, this analysis is a determination of whether the benefit outweighs the potential risk. During this analysis process individual and group tolerances, or acceptability levels, begin to influence what would otherwise be a primarily objective or scientific assessment process.

Overview
On the surface, risk assessment can appear to be fairly simple and based solely on measurable, scientific parameters. There are three basic components in the biological risk assessment triad: biological agent, host, and environment (Figure 1). Upon closer consideration of these components it becomes apparent that the model must be expanded to better identify objective as well as subjective influences (Figure 2) (Johnson, 1996; Johnson, 2000). These subjective factors include but are not limited to community, societal and political perception, environmental concern, personal stress, and feelings of vulnerability or impending personal risk. More and more the subjective factors are playing an increased role in successful risk assessment, mitigation, and communication. Community individuals, government officials, and various activists are increasingly aware of and vocal regarding issues related to scientific research and biosafety. They base their premises and understanding of issues on scientific, global, political, and pseudoscientific information, as well as pure propaganda. Where scientists, biosafety officers, and Institute officials often "miss the boat" is in communicating proactively with the public, or those who feel they will be put at risk by some activity associated with the institute or its work. Proactive communication must be done not onltonly before a concern becomes a heated issue, but in a credible manner which can be comprehended by the target audience.

Figure 1. Basic Risk Assessment Triad - Biological Agent/Host/Environment

Examples of elements that influence objectives and subjective elements of risk assessment are listed in Table 1 (Mackel & Forney, 1986). To differing degrees characteristics of these factors can repeatedly demonstrate cause-effect, be experimentally reproduced, and be quantitatively or qualitatively measured or described. The information in Table 1 and the following tables are not all-inclusive, but serve as a general guideline for the basis of factors to include in the assessment process. In addition to this chapter, several comprehensive guidelines have been written that consider factors such as route of infection, severity of disease, communicability, prophylaxis and treatment, facility design and mitigative practices when developing risk group definitions or when assigning organisms to risk groups (Biological Defense Safety Program, 1993a, 1993b; Collins, 1993; Kennedy, 1996; Richmond & Mckinney, 1999; Dept of Defense, 1993; Russian State Committee, 1994; Sanitary Regulations, 1994). Each of these guidelines has been compiled and revised over time by biosafety and research experts, and can serve as excellent references for the Risk Management Team. Each guideline shares areas of commonality and espouses some divergent views, increasing their collective value as teaching tools and providing the reader options that may best fit their facility mission and operations. The following is a brief discussion of how factors in Table 1 affect assigning risk.

Figure 2. Expanded Risk Assessment Factors

Table 1. Objective Factors in Risk Assessment
Method of Transmission:
Direct versus indirect contact
Airborne versus vehicle
Vectors
Route of Infection:
Inhalation
Ingestion
Inoculation
Penetration of abraded skin or mucous
Bites (animals or insect)
Biological Agent:
Pathogenicity (severity) or ability to intoxicate
Infectious or intoxicating dose
Effect of route of exposure (infectious dose and intoxicating dose vary with route of exposure
Virulence (primary or secondary communicability)
Host susceptibility or resistance (genetic composition, age, gender, race)
Biological modifiers to resistance (preexisting condition, secondary infection, pregnancy, stress, immunosuppression, vaccination)
Sensitization reactions (allergen, acute hypersensitivity)
Incidence of laboratory infections
Treatment (success rate considering various routes of exposure and doses, antibiotic resistance and susceptibility)
Environmental impact (survival and dissemination in the environment, remediation, public health concerns, impact on humans, flora and fauna)
Unique animal hazards:
Species ectoparasite vectors (fleas, ticks, lice)
Species specific inapparent infections (SIV, monkey B virus, TB, Hepatitis)
Agent excretion in urine, feces, saliva, blood (offspring) transmission
Escape
Environmental factors:
Ventilation and laboratory design (directional air, pressure gradients, airbreaks, separation of laboratories from offices, interlocking autoclave and airlock doors)
Laboratory procedures (recapping needles, use of sharps, mouth pipetting, minimization of creating aerosols)
Containment equipment (Class II and III biosafety cabinets, sealed centrifuges cups and rotors, gasket seals and unbreakable tubes)
PPE (gloves, goggles, respirators, aprons, gowns)
Training (handling, containment, destruction and transporting pathogens, emergency evacuation, spill procedures)
Laboratory sanitation (decontamination, housekeeping disinfection, routine cleaning, pest and rodent control)


Objective Components
In considering modes of transmission, a higher level of risk is associated with agents transmitted via aerosol route or by indirect contact (via fomites), as opposed to those requiring direct contact, a vehicle or vector. Aerosols are relatively easy to generate, difficult to contain/control, and need not be of a respirable size to cause infection (e.g., larger particles may cause infection through contact via the ocular route). Similarly, it may be difficult to identify and control the movement of carrier materials (fomites) when preventing the spread of infection. Organisms that can be spread by fomites are generally more environmentally stable than those requiring direct contact. When organisms require a vehicle (i.e., sharps) or vector (i.e., insect), transmission becomes a more complex event and may also provide additional steps where mitigative procedures can reduce potential infection. A notable exception is when there is a reasonable potential for the escape of infected vectors, resulting in an increase in the risk associated with a process. In these examples factors which increase uncertainty by reducing our ability to control, contain, and prevent transmission of the organism are contributory for assigning increased risk.

The route of infection, which is related to but different from transmission, also plays a strong role in the assessment process. Work with agents that cause infection via inhalation exposure is considered inherently to be more hazardous than work with agents that cause infection by percutaneous or oral exposure. Inhalation exposure is difficult to prevent because aerosols can be so easily produced. Many common laboratory, clinical, and medical procedures are associated with the inadvertent production of aerosols (e.g., opening "pop-cap" tubes, removing a syringe from a stoppered pressurized bottle, centrifugation, homogenization or vortexing, shaker operations, flame sterilizing inoculation loops, performing bronchoscopies, surgical procedures, etc.). Because aerosol production may be difficult to attribute to a given activity, individuals may not be using the appropriate personal protective equipment (PPE) or using other mitigative measures. Retrospectively, many laboratory-acquired infections not associated with an accident/incident are believed to result from inadvertent aerosol exposures (Gaidamorich, Butenko & Leshinskaya, 2000; Pike, 1976).

Pathogenicity, virulence, available treatment and prophylaxis, and infectious dose are among the most heavily weighed factors when evaluating hazards associated with microorganisms and their products. The guidelines are fairly uniform in their assessments that exotic agents capable of causing severe disease or death are assigned to the highest risk group. While some factors related to agents could be measured, the pathogen host interaction is highly complex and varied, due in part to human individual differences and factors that modify host response. The effect of many of the modifiers and the interactions between modifiers can not be statistically or quantitatively measured, leaving some degree of uncertainty or risk (i.e., age, genetic composition, immune responsiveness, pregnancy, stress, preexisting conditions, indigenous microflora, etc.) (Smith & Huggins, 1976). An individual need not have a clinical history of immunosuppression to experience transient periods of decreased immunoresponiveness due to stress, medication, convalescence period from a secondary infection, or other factors. Conversely, some individuals may maintain a slightly heightened state of immunoresponsiveness due to the colonization of beneficial commensal microflora (Stiehm et al, 1984). These indigenous organisms not only act to maintain a low level priming effect for the immune system via displays of MHC II and produce bacteriocins, but also compete with pathogens for receptor binding sites and nutrients. Finally, as alluded to earlier, a group of individuals can be immunized and display varied levels of responsiveness to the vaccine and subsequent challenge. These individual host effects, coupled with the organism's viability, route of infection, and successful interaction with a permissive host cell, make it impossible to predict the exact dose required to cause infection.

Animal- and vector-related hazards have become increasingly recognized for their role in hazard assessment. In addition to understanding the physical risks associated with animal and vector work it is also helpful to understand the elements associated with the transmission and infection process (DeRoos, 1985). Table 2 outlines six basic links required for transmission of disease from vectors to humans. In risk mitigation, breaking one or more of these links will prevent the transmission of disease. When thinking of animal-associated risk, in the past, physical trauma in the form of bites, scratches, and kicks were among the predominant factors discussed with regards to occupational hazard. Over time with the recognition of inapparent, latent, and recrudescent infections (i.e., Marburg virus, monkey B virus [a.k.a. Herpesvirus simiae or Cercopithecine herpesvirus], and others), as well as slow pathologies (prion agents, retroviruses) which have severe outcomes in man, hazard assessment has broadened its scope (Weigler, 1992; Will et al, 1996). Assessing the threat of developing animal allergies, while not commonly life-threatening, should be a consideration in a complete risk assessment. As new technologies and interfaces between humans and animals are developed, like xenogenic transplantation, there will be new risks to assess. Thought also must be given to the "reverse view of risk assessment" pertaining to work with animals, in particular in the prevention of humans spreading infection to animals (i.e., TB).

Table 2. Elements of Disease Transmission
Animal and Vector Transmission Factors:
Presence of etiologic agent
Presence of reservoir or source of the agent
Mode of escape from the reservoir
Mode of transmission from the reservoir to the new host
Entry into the new host
Host susceptibility


Risk assessment considers not only host-pathogen-vector relationships. There are two previously unmentioned classes of objective factors that have profound influence on the mitigation of risk when applied properly; these are good microbiological practice and engineering applications. For the purpose of this chapter engineering applications encompass primary and secondary containment devices, as well as personal protective equipment (PPE). Articles, chapters, and books have been written describing the role of good microbiological procedures, and procedures which can result in exposure to microorganisms, as well as facility design, containment equipment, and PPE (ASHRAE, 1999; Kennedy, 1986; Natl Research Council, 1989; Richmond, 1996a, 1996b, 1997, 1998, 1999).

The factors that contribute to uncertainty in the assessment process make it nearly impossible to treat biological risk assessment (qualitative) in the same way as many chemical assessments (quantitative). While qualitative models do not provide exact risk indices, they have the advantage of visually demonstrating what aspect of work is associated with the greatest or least degree of risk (Knudsen, 1998). Numerous formulas have been generated to assist in assessing risk. Often in the context of chemical hygiene, components of risk include the probability of an accident, probable exposure of a person or the environment resulting from the accident, and the effect of exposure (Nicas, 1994). Risk models with probabilities and quantitative values can be developed for exposure to formaldehyde (i.e., following decontamination of a laboratory), as formaldehyde gas concentrations are measurable and their effects on tissue and the respiratory tract are well documented. The same applies to numerous industrial chemicals commonly used in the lab (e.g., acids, ethylene oxide, caustic materials, etc.). The ability to quantitate exposure and correlate it to levels of harm has led to the development of threshold levels and permissible exposure levels (PELs). Material Safety Data Sheets (MSDS) have been developed which describe the properties and hazards associated with chemicals, as well as mitigation to exposure, treatment, and emergency procedures. While threshold levels and PELs may not formally exist for biological materials, several organizations and some vendors have developed biological agent summary sheets (BASS), which are analogous to MSDS. (Johnson, 1994; Personal Communication, 1999, 2000). It is a strong recommendation that each Institute develops or obtains BASS for use in risk assessment, communication and training.

Models for specific types of biological exposure have been developed (Nicas, 1994). A subject of intense study has been developing a quantitative model for the transmission of Mycobacterium tuberculosis. Over the years the cumulative risk of infection with TB has been estimated using Poisson probability models (Nardell et al, 1991; Riley et al, 1962; Wells, 1995). The models are detailed with regards to volume of room air, respiration rate and volume, time spent in the room, air exchange rate, and the number of infectious doses emitted into the room. There are several problems with the model, one of the most serious being that the number of organisms required to infect a human was derived from experimental data demonstrating that one viable, infectious organism when delivered to the appropriate site in the lung of a rabbit could cause infection. If we accept this model we must assume that all aerosolized particles are viable, the correct size, will deposit in appropriate tissues in the lung, and that human susceptibility is equivalent to that of a rabbit. This example was provided to demonstrate the following points:

  1. exact human epidemiologic data may be lacking in many risk assessments,
  2. caution must be exercised in extrapolating laboratory generated data to "real life" situations; and
  3. parameters generated for use in a model can serve as valuable guidelines, but often not as absolute values used to calculate a quantitative assessment of risk.

Subjective Components
Identifying, assessing, and addressing the subjective and often emotional factors associated with risk usually prove to be far more difficult than addressing objective factors. These factors generally do not play a role regarding worker safety in the laboratory, but rather they can play a role in whether the mission, project, or facility operations are preformed. Table 3 lists some subjective factors frequently encountered. Each element merits an explanation.



Table 3. Subjective Factors Influencing Risk Assessment
Ethical and legal
Voluntary vs. involuntary
Societal acceptance and trust
Perceived harm or hazard
Political considerations / politicization


Ethical and legal factors were most commonly encountered in association with medical studies, medical procedures, vaccine and therapeutic challenge studies, and the administration of investigational new drugs. New and increasingly publicized topics include:

While these topics do not appear to be "risk factors." an Institute or granting organization's Review Board, Bioethical, or Animal Care and Use Committee could determine that the risk posed to the subjects involved in the study outweighs the benefits of the information. These and the other subjective factors, when not adequately addressed, put not only the subjects at risk but also thealso the project/program at risk of cancellation.

The concept "voluntary vs. involuntary" exposure to risk is an increasingly prevalent community concern. Even if the fact that the fears and concerns expressed are largely unfounded and improbable can be effectively communicated, it may be impossible to gain community support if members of the community must involuntarily accept your proposal. The "NIMBY Syndrome" (Not In My Back Yard) was responsible for preventing a state-of-the-art laboratory containment facility from conducting its intended research in Canada (Toronto). The community was not involved early in the decision-making process during the planning and construction of the facility, and felt they were being put at risk by the new laboratory. They successfully lobbied to prevent facility operations. Examples of a proactive approaches that include strong community outreach have been demonstrated by the Centers for Disease Control snf and Prevention (Atlanta, GA) and Health and Welfare Canada/ Agriculture Canada (Winnipeg, Canada) when each has proposed the construction of new maximum containment facilities. They were able to immediately dispel misconceptions before they became issues and gain community support bysupport by making the community part of the project from the beginning.

Societal acceptance and trust are perhaps one of the most difficult perceptions to change once a negative opinion has been developed. This topic is more complex than the concept of people not trusting what they do not understand, which is attributed to many of the current problems with genetically modified crops, milk from recombinant somatotropin treated cows, and other scientifically modified products. Part of the problem is with the societal perception that scientists are daring-risk takers, and the community is their laboratory. To change this misperception scientists will have to embark upon a serious and dedicated public outreach and educational program. Societal acceptance or lack thereof is not restricted to scientific products it extends to industries and organizations. A review of popular press articles over any given year will reveal public outrage or mistrust of laboratories associated with many government organizations to include but not be limited to the Department of Energy, Department of Agriculture, and Department of Defense. Unfounded as many of these articles may be, they are effective in disrupting research programs, funding, and long-range organizational planning. Organizations must weigh the risk of not making every effort to promote acceptance and trust against the risk of potential lost mission, time, and money if community relations are poor. It has been the experience of the author that the effort is not only worthwhile, but essential. While you may never be able to reason with and gain the trust or acceptance of everyone in the community, oftentimes the majority of a community will accept a program following full, open, and honest disclosure regarding mission, most probable risk, and safety measures.

Societal acceptance also changes over time due to new circumstances even though a particular level of risk does not change. An example is reflected in society's willingness to vaccinate children. Until the administration of the DPT vaccine in the 1950s, whooping cough was a major lethal disease of children. Mild side effects were not uncommon (20% of children experienced local pain and general malaise), less than 0.1% of immunized children had more severe side effects, and instances of irreversible neurologic damage were extremely rare. Since whooping cough was a serious and common disease at the time, parents assessed the low risk of serious side effects to be acceptable when weighed against the probability of contracting the disease. As routine vaccination has almost eliminated the disease, parents have reassessed the risk of serious side effects to be unacceptable. The level of risk posed by the vaccine had not changed, but the vaccine risk was elevated in the face of the reduced threat of disease.

Perceived harm or hazard can take any form from the fear of an aerosol release, infected animal/vector escape, or an exposed laboratorian infecting the community, to the fear that property values will decrease if a laboratory is built or becomes operational nearby, or it will attract a terrorist incident in the neighborhood. Perception, like acceptance or trust, has a lot to do with communicating with the public. Many perceptions are based on urban legends and recounts of incidents that are sufficiently altered from the original incident that it bares little resemblance to the original account.

Political motivations and the subsequent politicization of risk are another subjective factors. Suffice it to say, in the face of a large voting constituent opposed to a project, an objective assessment and rational decision may not always be proffered by local officials. In these instances the construction of a maximum containment facility may be denied at the local level despite its necessity, planned location in a remote or otherwise appropriate area, design that incorporates state-of-the-art safety engineering systems, and its ability to stimulate the local economy with employment and support services.

While not a subjective factor per se, recent popular press accounts and best sellers have glorified maximum containment, work with the most highly dangerous pathogens, and the heroic if not macho/"macha" nature of scientists who work in space suits. Several colleagues have mentioned recent similar experiences at their facility that may be a result of this recent media hype. The experience they each share is one where a laboratorian suddenly states that the work he/she conducts with a particular organism poses a significantly higher risk than previously assessed, and they must now conduct their work in a high containment lab (i.e., work in BL-3 as opposed to BL-2). Close reevaluation of the risks do not support the move to high containment and the required practices however, even following a thorough and interactive discussion and evaluation of the risks, the individual believes the work must be done in higher containment. In discussion with my colleagues, it is believed that certain individuals have a character trait, which requires they be equated with the workers who are the subject of the media attention. Their approach to attain this notoriety is to be able to say, "I work in high containment too". While it is not the objective of this chapter to engage in a discussion of character traits or their implications, the effect of placating the desire to work (unnecessarily) at higher containment levels is discussed below.

Subjective factors and other non-objectively based influences are most often responsible for driving the perception of risk to an increased level. If the scientific community does not promote a more active risk communication and community outreach program, one that includes media participation and education, there could be long-range impact on how we currently conduct research. The author speculates misperception could lead to the beginning of a new phenomena to drive requirements for providing higher containment capabilities and more stringent requirements when conducting what would be considered otherwise routine work with BL-2 and BL-3 organisms. The result will be manifested financially in higher cost of construction, operation, and product development, and may adversely impact safety by unnecessarily increasing worker fatigue with added procedures and equipment requirements. Imagine the impact on a research, clinical, or reference lab that routinely works with diagnostic samples believed to contain enterohemorrhagic strains of E. coli, should it become expected to implement recommended BL-3 practices, equipment, and facility engineering. While this example and the one in the paragraph above may appear extreme, they contribute to the potential for "containment creep."

Risk Communication
The requirement and some approaches for communicating work-related risk with employees has been discussed earlier in this chapter. The need and benefits associated with communicating risk at the broad programmatic level have become more obvious in recent years. How risk is communicated, who communicates it, and the various options for communication will be addressed below. Before risk can be communicated it must be identified, and identified in a context. It also is helpful to know the target audience so the information can be tailored to their technical level of understanding and thus address their concerns adequately. Methods for presentation and dissemination can then be chosen which best communicate the information and reach the largest segment of the audience.

The context in which risk is described should depend on the needs of the organization and may be associated with the most probable event, the maximum credible event, or the worst case scenario or catastrophic event. It is a good idea to develop scenarios and explanations for each of these types of events, though hopefully the target audience is most interested in what risks are the most realistic and probable.

The most probable event includes common and likely accidents and incidents with a reasonable probability of occurring, such as needle sticks, sharps accidents, spills or splashes, leakage within the centrifuge bucket, dropping culture plates while transporting them form the incubator to the BSC, etc. These incidents may involve infectious material or potentially infectious samples. They will generally involve one or possibly two people. Most probable events are the easiest to control by developing a risk matrix, identifying where accidents can occur, and providing procedures or protective/containment devices to prevent and mitigate the risk.

The maximum credible event is one that we plan for, but has an unlikely, even rare probability of occurring. These events include a worker unknowingly infecting herself or himself (and having normal community interactions until diagnosed), exhaust fan failure, escape of infected animals or vectors from their cages, and discarding an incompletely sterilized waste. Generally, we have all heard or read of these types of incidents, but few of us have experienced them at our facilities. Preventing many of these events requires considerable preplanning and will employ administrative, procedural, and engineering solutions. Generally, when discussing the most probable and maximum credible events, the emphasis of the communication is on what you could have done to prevent this from happening and, secondarily, what you will do to mitigate the threat to the community in the event that it does happen.

Finally, the worst case scenario or catastrophic event is one that has a remote probability of occurring, and in truth may not be preventable. The first objective in communicating risk in this category is to be able to provide data and comparative information regarding the probability of the event. If the probability of the occurrence is on the order of magnitude of one in a million or a billion, it is useful to demonstrate this and put it in the context of more common risks to the audience (i.e., car accidents, being hit by lightning, etc.). The second objective is to be able to discuss how the mitigative procedures at the facility will prevent the release of hazardous material which would then threaten the community, or why the release of the quantity of material available will not pose a hazard to the community. These scenarios often involve extraordinary acts of nature such as huge coastal surges (i.e., 40-foot surge), 7+ Richter scale earthquakes, and meteorites or stray aircraft falling on the maximum containment lab. In these cases the fact that materials are double contained when work is not in progress, secured during the threat of inclement conditions, only worked with in small quantities, and are labile in the environment, are all valid reasons as to why there is a minimal threat of exposure to the community.

A decision must be made regarding who will be the spokesperson for the facility or program. This person will be the primary liaison between the community, media, and program or facility director. While the BSO and senior scientist had been designated as communicators of risk at the worker level, they may not be the principle spokesperson for the program (rather they may be called upon periodically as technical experts for highly defined topics). Typically, in large programs the institute Director will designate a public affairs officer (PAO) as the spokesperson. In programs that lack a PAO the Director may act as the spokesperson. In either case, information is developed by a team of specialists in support of the spokesperson. Depending on the risks assessed the team may comprise the BSO and other safety elements, Occupational Health, Environmental Safety, Industrial Hygiene, Veterinary Support, Facilities Engineering, Legal Council, etc. Generally all the information will be provided to a focal point and incorporated into a comprehensive document that addresses each element of risk. The spokesperson will use this information, often verbatim as the team represents the program. It is vital for this reason to provide accurate, current, and concise information.

There are a variety of forums the spokesperson may engage in the communication. Depending on the forum, the spokesperson may be supported by other team members. Some committees, while predominantly staffed by institute personnel, include local public representatives and in that capacity serve as conduits for communication. Examples include the Institution Biological Safety Committee, Animal Care and Use Committee, Employee Union Representatives, and Institution Review Board. More public-oriented forums include specially called Civic or Town Meetings, Meetings of the Local Health Department, and Physician Group Meetings. Finally, information can be communicated in the form of National Environmental Protection Agency documentation and a Programmatic Environmental Impact Statement. This level of rigor is very costly, and requires considerable time in development and approval. They include thorough environmental impact information, risk-benefit analysis, hazard analysis and mitigation information, past history and projected mission objective, and other topics. These documents are open to public comment and must address public comments before they can be considered complete and further action can be taken. Often, changes to mission, program, biosafety operational level, types of organisms or animals involved with the work, new construction or renovation, and other parameters will draw attention to the program and/or require public disclosure. Plan ahead and determine whether there are sensitivities, and what it will require to address them. A proactive approach can prevent mission delay and is essential in fostering trust and confidence within the community and workforce.

Conclusion
The ability to accurately and successfully understand, assess, mitigate, and communicate risk, both in the workplace and in the broader community setting, is essential for maintaining and expanding established programs, and for initiating new programs and construction projects associated with high and maximum containment operations. Assessments that are technical in nature are based largely on objective factors, and are often directed at the actual day-to-day work in the laboratory. Subjective factors in the programmatic world begin to increase in the assessment process and this endeavor increasingly requires a multidisciplinary, coordinated team approach to provide and adequately communicate a thorough and valid assessment. A significant deciding aspect in the well-being of an existing or future program or facility is dependent on a plan which addresses risk assessment and communication, regardless of whether it is developed for the laboratorian or the local community.

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Citation:
Barbara Johnson, PhD, RBP - Understanding, Assessing, and Communicating Topics Related to Risk in Biomedical Research Facilities, ABSA Anthology of Biosafety IV - Issues in Public Health, Chapter 10 (2001),
http://www.absa.org/0100johnson.html.

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