7
Designing a Beryllium Exposure-and Disease-Management Program for Workers in the Air Force

Beryllium sensitization (BeS), chronic beryllium disease (CBD), and lung cancer are the principal health concerns related to exposure to beryllium. Because of a lack of quantitative risk information on low exposure and uncertainties associated with factors that contribute to the development of CBD (see Chapter 3), the committee was unable to identify a chronic inhalation exposure level that is unlikely to produce BeS or CBD. Therefore, the committee recommended, in Chapter 3, that an exposure- and disease-management program be implemented to manage potential health risks posed by exposure to beryllium. This chapter provides some general guidelines for designing a preventive program.

EXISTING MEDICAL SCREENING OR SURVEILLANCE PRACTICES

Published beryllium exposure-management programs are summarized in Table 7-1. Deubner and Kent (2007) describe Brush Wellman’s extensive beryllium-management program. The goals of the program are to keep beryllium work areas clean; to keep beryllium out of the lungs, off the skin, and off clothing in the work process, in the work area, and on the plant site; and to keep workers prepared to work safely. On the basis of surveillance data, the program reduced BeS from 18% (before program implementation) to 1.1% in 24 months. Cummings et al. (2007) present an analysis of sensitization rates before and after the implementation of Brush Wellman’s enhanced beryllium-management program. They also document a BeS reduction associated with the program. The postimplementation sensitization rate was 1%, similar to that in the study by



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7 Designing a Beryllium Exposure- and Disease-Management Program for Workers in the Air Force Beryllium sensitization (BeS), chronic beryllium disease (CBD), and lung cancer are the principal health concerns related to exposure to beryllium. Because of a lack of quantitative risk information on low exposure and uncertainties asso- ciated with factors that contribute to the development of CBD (see Chapter 3), the committee was unable to identify a chronic inhalation exposure level that is unlikely to produce BeS or CBD. Therefore, the committee recommended, in Chapter 3, that an exposure- and disease-management program be implemented to manage potential health risks posed by exposure to beryllium. This chapter pro- vides some general guidelines for designing a preventive program. EXISTING MEDICAL SCREENING OR SURVEILLANCE PRACTICES Published beryllium exposure-management programs are summarized in Table 7-1. Deubner and Kent (2007) describe Brush Wellman’s extensive beryl- lium-management program. The goals of the program are to keep beryllium work areas clean; to keep beryllium out of the lungs, off the skin, and off cloth- ing in the work process, in the work area, and on the plant site; and to keep workers prepared to work safely. On the basis of surveillance data, the program reduced BeS from 18% (before program implementation) to 1.1% in 24 months. Cummings et al. (2007) present an analysis of sensitization rates before and after the implementation of Brush Wellman’s enhanced beryllium-management pro- gram. They also document a BeS reduction associated with the program. The postimplementation sensitization rate was 1%, similar to that in the study by 127

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TABLE 7-1 Summary of Published Beryllium Exposure-Management Programs 128 Workers Program Components Comments Reference Brush Wellman Respiratory protection Program implementation Deubner and workers Dermal protection reduced BeS to Kent 2007 Work-area and plant hygiene practices 1.1% in new Worker training workers Atomic-weapons Engineering controls Program generally keeps Johnson et workers in United Respiratory protection exposures below 2 µg/m3 al. 2001 Kingdom Work-area hygiene practices Only one case of CBD in Medical surveillance for CBD 400 workers Beryllium workers For workers: NIOSH 2008 Understand risks Avoid inhalation and skin contact Avoid dust-suspending activities Participate in medical surveillance For employers: Knowing beryllium content of all materials Substitution of less hazardous materials, if feasible Minimizing number of workers exposed Engineering controls Keeping airborne concentrations as low as possible Exposure monitoring Risk communication Confining beryllium contamination to work area Respiratory protection Dermal protection Medical surveillance

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DOE and DOE Baseline inventory to identify operations and locations of potential 10 CFR 850 contractor workers beryllium contamination with potential Hazard assessment beryllium Initial exposure monitoring exposure Limitation of access to areas containing beryllium Reduction and minimization of exposures through engineering and work- practice controls Keeping exposures below PEL of 2.0 µg/m3 Provision of respirators when requested by workers Setting of action level at 0.2 µg/m3 (8-h TWA) Maintaining removable surface contamination below 3 µg/100 cm2 in designated beryllium-handling areas and below 0.2 µg/100 cm2 when released to the public or for nonberyllium use For all areas exceeding action level, provision of protective respiratory, clothing, and other equipment; periodic monitoring; regulation of access to that area; installation of hygiene facilities and institution of hygiene practices; posting of warning signs Medical surveillance of all beryllium-associated workers Training of workers who could potentially be exposed Counseling of workers who have diagnosis of BeS or CBD Offer of medical-removal protection to sick or sensitized workers Accurate records of all information gathered Monitoring of the effectiveness of the program and provision of performance feedback 129

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130 Managing Health Effects of Beryllium Exposure Deubner and Kent. The sensitization rate in preimplementation workers was 8%. Johnson et al. (2001) described a beryllium-management program for atomic- weapons establishments in the United Kingdom. That program is similar to the Brush Wellman program. Its adoption reduced exposures to less than 2 µg/m3. The facility has documented only one case of CBD, which was detected by us- ing a medical monitoring program that did not include the beryllium lymphocyte proliferation test (BeLPT). That CBD case is considered unique in that it proba- bly occurred as a result of a systemic reaction to beryllium oxide contamination of a cut. This facility does not routinely evaluate BeS with the BeLPT, so the effect of the program on sensitization and early-stage CBD is unknown. Several approaches for screening or surveillance of beryllium workers can be found in the scientific literature (see Table 7-2 for some examples). Most of the studies have focused on evaluating the performance of the BeLPT, and were not designed to determine the appropriate selection of tests and the optimal fre- quency of testing for medical surveillance and screening. As indicated in the table, a questionnaire has been used in most of the studies to include occupa- tional history, occupational exposure, and medical information (such as smoking history, previous respiratory disease, respiratory and dermatologic symptoms, fatigue, weight loss, and medication use). Use of the BeLPT has been included in most surveillance and screening programs since the test has been available; an exception is the UK atomic weapons facility, where the BeLPT was used until the middle 1980s and is now only used on request (Johnson et al. 2001). CONSIDERATIONS FOR THE AIR FORCE The committee had little information on current or former workers and the extent or structure of the workforce with potential beryllium exposure, such as enlisted personnel, civilian employees, and subcontractors. The prevalence of BeS or CBD (if any) in Air Force personnel is not known, inasmuch as the ser- vice has not performed any systematic surveillance of its workers for BeS or CBD. Thus, the proposed beryllium exposure- and disease-management pro- gram described below is a general outline of a program that should be tailored to the Air Force’s needs as more information becomes available. Figure 7-1 shows a framework for minimizing personnel exposure and risks posed by exposure to aerosolized beryllium in the Air Force. Key aspects of the framework are discussed below, and general recommendations for moni- toring and testing are provided. The first years in which the management pro- gram is in place will include a period of information-gathering, when more is learned about the type of workplace settings with beryllium exposure in the Air Force and about the prevalence of BeS and CBD, if any, in the settings. With time, the initial testing and monitoring practices should be refined as more in- formation is gathered on the specific risks of BeS and CBD in the Air Force and as any new research findings appear in the scientific literature. In addition, the

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131 Designing a Beryllium Exposure- and Disease-Management Program TABLE 7-2 Medical Screening Tests Used in Beryllium-Exposed Populations Cross-Sectional or Repeated Test Workers Intervals Tests Reference Aluminum smelter Annual Qx, spirometry, Taiwo et al. 2008 BeLPT Beryllium-material At hire; 3, 6, 12, 24 BeLPT Deubner and Kent 2007 production mon Brush Wellman At hire; 3, 6, 12, 24, BeLPT Donovan et al. 2007 plants 48 mon Ceramic At hire; 3, 6, 12, 24, BeLPT Cumming et al. 2007 48 mon Copper-beryllium CS Qx, BeLPT Stanton et al. 2006 alloy distribution Copper-beryllium CS Qx, BeLPT Schuler et al. 2005 alloy Nuclear facility CS Qx, spirometry, CXR, Sackett et al. 2004 BeLPT DOE nuclear facility CS Qx, CXR, BeLPT Welch et al. 2004 Machining Every 2 y (new and Qx, BeLPT Newman et al. 2001 rehired within 3 mon of starting) UK atomic-weapons Monthly spirometry, Clinical and physical Johnson et al. 2001 facility annual CXR examinations, spirometry, CXR (BeLPT used until middle 1980s, then only if requested) Mining and milling Quarterly or annual PFT, CXR, later Deubner et al. 2001a PFT, including BeLPT, Qx DLCO and CXR since 1969, then 1996-1997 Qx and BeLPT Ceramic Annual Qx, PFT, Qx, CXR, PFT, Henneberger et al. 2001 CXR; CS BeLPT in BeLPT 1992, 1998 Metal alloy and oxide CS Qx, BeLPT Kreiss et al. 1997 Ceramic CS Qx, BeLPT, CXR Kreiss et al. 1996 Nuclear Two tests at 3-y Qx, CXR, BeLPT Stange et al. 1996b intervals Ceramic CS Qx, BeLPT, CXR Kreiss et al. 1993a (Continued)

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132 Managing Health Effects of Beryllium Exposure TABLE 7-2 Continued Cross-Sectional or Repeated Test Workers Intervals Tests Reference Nuclear CS Qx, BeLPT, CXR, Kreiss et al. 1993b spirometry Nuclear machining CS Qx, BeLPT, CXR, Kreiss et al. 1989 spirometry Beryllium factory Every 3 y since 1977 Qx, spirometry, CXR, Kriebel et al. 1988 blood gases Mine and mill Twice at 3-y Spirometry, BeLPT Rom et al. 1983 intervals Abbreviations: BeLPT, beryllium lymphocyte proliferation test; CS, cross-sectional; CXR, chest x ray; DLCO, carbon monoxide diffusing capacity; DOE, Department of Energy; PFT, pulmonary-function test; Qx, questionnaire. findings from the management program should be used to consider whether it would be prudent to evaluate beryllium exposures and potential risks to former Air Force workers. Identify Jobs and Tasks with Potential Exposure to Beryllium Particles Assess Beryllium Exposures Identify Workers with Potential Exposure to Implement Exposure Reduction Plan Beryllium Particles (see Figure 7-2) Enroll Workers in Medical Surveillance & Conduct Exposure Monitoring Management Program Centralized Surveillance Data Base Evaluate effectiveness of industrial hygiene and surveillance program FIGURE 7-1 Beryllium exposure- and disease-management program.

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133 Designing a Beryllium Exposure- and Disease-Management Program Exposure Assessment A detailed exposure assessment is a key element of a beryllium- management program. The exposure-assessment strategy should be modeled after the recommendations contained in the American Industrial Hygiene Asso- ciation’s manual for assessing and managing occupational exposures (Ignacio and Bullock 2006). Briefly, the strategy should begin with an initial job or task characterization. The purpose of the initial characterization is to identify all jobs and tasks that have a potential for skin or respiratory beryllium exposure. Beryl- lium-containing materials should be characterized as to where they are used or were used in the past, their alloy content, their potential for contact that could lead to dermal or inhalation exposure, and the presence of any exposure con- trols. After the basic characterization, exposures should be assessed with air and surface sampling. As noted in Chapter 2, there are several analytic approaches for detecting airborne beryllium. Air samples are typically measured by either flame atomic absorption spectroscopy or inductively-coupled plasma atomic emission spectrometry, but other methods are available (see Chapter 2). Given the available Air Force sampling data, a method should be chosen that maxi- mizes analytical sensitivity. For jobs or tasks identified as having detectable airborne beryllium, consideration should be given to determining the beryllium particle size distribution by using stationary or personal cascade impactors. De- termining the particle size distribution may require pooling samples related to a given job or task to provide detectable quantities of beryllium. Beryllium surface sampling should conform with standard practices (such as the Department of Energy’s Chronic Beryllium Disease Prevention Program, 64 Fed. Reg. 68854 [1999]). Samples with surface beryllium exceeding background levels of remov- able contamination on equipment surfaces should be investigated for the source of contamination. The goal of sampling is to identify jobs that entail detectable airborne or dermal exposure. Workers in those jobs should be targeted for expo- sure reduction and medical monitoring. Exposure Reduction and Prevention Measures should be taken to prevent skin and respiratory exposure to be- ryllium to the greatest extent possible. The control measures detailed in the Na- tional Institute for Occupational Safety and Health (NIOSH 2008) draft docu- ment on Preventing Chronic Beryllium Disease and Beryllium Sensitization and similar resources from DOE (10 CFR 850) and Brush Wellman (Deubner and Kent 2007). The measures include the following: • Know the beryllium content of all materials in the workplace. The manufacturers or suppliers of materials containing more than 0.1% beryllium are required to provide this information on material-safety data sheets. Upstream-

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134 Managing Health Effects of Beryllium Exposure production information might be needed to assemble a comprehensive list of materials used by the Air Force and its subcontractors. • Substitute less hazardous materials for those containing beryllium whenever feasible. • Keep airborne concentrations of beryllium as low as possible because no safe exposure limit for beryllium is known. • Minimize the number of workers exposed to beryllium dusts, fumes, and contaminated surfaces. • Install, use, and maintain effective engineering controls for processes that create beryllium dusts and fumes. • Monitor airborne beryllium concentrations to document the effective- ness of efforts to reduce airborne exposure. • Inform workers about the risks of BeS, CBD, and lung cancer and the proper procedures for working with beryllium-containing materials. • Keep beryllium dusts and fumes confined to the immediate work area. • Avoid the use of cleaning methods that may cause dust to become re- suspended in air (for example, dry sweeping, use of compressed air, and other dust-generating methods). • Prevent beryllium dusts and other contamination from leaving beryl- lium work areas on equipment or workers’ skin, clothing, shoes, and tools. • Identify and clean areas in and outside the beryllium work zone that may have become contaminated before these recommendations were implemented. • Establish and maintain an appropriate respiratory-protection program. • Establish and maintain a skin-protection program to protect workers’ skin from contamination with beryllium dusts and solutions by keeping work surfaces and work areas clean; providing work gloves, long-sleeved shirts, long pants, and shoes that remain at the workplace; and providing showering and changing facilities. Worker Education and Training Programs Worker education and training programs should be in place and should in- clude education of all new and current workers with potential for beryllium ex- posure as to health risks of beryllium, appropriate exposure reduction, and use of skin and respiratory protective equipment. Such programs have been imple- mented in a beryllium-products manufacturing plant (Deubner and Kent 2007) and in the Department of Energy’s CBD-prevention program (DOE 2001). A similar program should be tailored to the Air Force’s work settings and work- force. Such a program could be coordinated with informing workers about the surveillance and medical-management program. The information provided should include the role of various screening and surveillance tests, risks related to the tests, and the health and occupational implications of positive test results. Education and training materials should developed to include information about

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135 Designing a Beryllium Exposure- and Disease-Management Program the medical and employment implications of the results of the BeLPT test and about potential long-term health risks after exposure ends. Identifying Workers Who Have Beryllium Sensitization or Chronic Beryllium Disease On the basis of the initial exposure evaluation, Air Force workers with ex- posure to beryllium—including civilian employees, onsite subcontractors, and workers who may be exposed incidentally—should be evaluated for possible BeS, and those with confirmed BeS should be further evaluated for CBD (see Figure 7-2). The medical screening program, including the BeLPT and diagnosis and management of workers with BeS and CBD, is described in greater detail below. Data from the screening program should be entered into the centralized database to facilitate evaluation of the effectiveness of the program and guide modifications (see discussion below). Workers with Exposure to Beryllium Particles Minimize exposure Worker education program Baseline questionnaire, Initial CXR, spirometry, BeLPT Sensitized or other Not sensitized abnormalities Periodic BeLPT, Clinical evaluation questionnaire, PFTs, DLCO, HRCT questionnaire, Consider pulmonary exercise testing and spirometry bronchoscopy, (Bx, BAL BeLPT) No CBD CBD Counsel about risk Counsel on medical and career implications Offer option to change job Advise removal from exposure No further beryllium Continued beryllium If worker elects to Remove from exposure, exposure, periodic exposure, periodic medical continue exposure, regular medical follow-up medical monitoring monitoring continue regular medical follow-up Centralized Surveillance Data Base (Figure 7-1) FIGURE 7-2 Medical monitoring approach.

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136 Managing Health Effects of Beryllium Exposure Limiting the Number of Beryllium Workers Limiting the number of workers exposed to beryllium in the Air Force is consistent with the industrial-hygiene hierarchy of controls. The workers should not only be skilled in operations involving beryllium but be trained in and committed to the safe use of beryllium and control of beryllium exposure as part of the overall beryllium-management plan. Medical screening and surveillance can then be targeted to the workers. Some aspects of this approach have been described in a report of an enhanced preventive model in a large beryllium- products manufacturing plant (Deubner and Kent 2007). The authors described limiting the number of workers exposed to beryllium and reducing worker turnover in areas of beryllium exposure, and they described a wall-enclosed, restricted access zone. They reported that those measures were implemented until engineering control changes could be completed at the plant. They also described enhanced worker preparation through training, education, and motivation. Centralized Surveillance Database Data obtained from the beryllium exposure-assessment and worker- surveillance programs at each Air Force site should be entered into a centralized surveillance database (Figure 7-1). Data should include airborne and surface beryllium-sampling data, job and task information, use of personal protective equipment, and clinical information, such as demographics, smoking, job his- tory, results of the BeLPT, spirometry, and additional testing (for example, high- resolution computed tomography and bronchoscopy). The prevalence of BeS and CBD should be determined, and assessments made of possible associations between prevalence and jobs and tasks or exposure. That information should then be used to refine and modify the program. For example, specific sites or job tasks with a higher prevalence of BeS might require greater attention to expo- sure control or more frequent medical monitoring. The effectiveness of the ex- posure-reduction plan on quantitative airborne and surface beryllium-sampling data should also be evaluated. In addition to facilitating assessment of the preva- lence of BeS and CBD in Air Force workers and the effectiveness of the pro- gram, the database could be used as a resource by investigators. The database should include followup clinical data on all workers identified with BeS and CBD so that questions regarding natural history and risk factors for progression can be addressed. SPECIFICS OF THE MEDICAL SCREENING PROGRAM Initial Medical Screening The committee advises that after workers have undergone education and training, including education as to the potential risks and benefits associated

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137 Designing a Beryllium Exposure- and Disease-Management Program with the screening procedures, there be initial screening of all workers with po- tential for beryllium exposure, including new hires before placement and current employees, and continuing screening of new hires and workers who might be moved from areas of no exposure to areas with potential exposure to beryllium. Each entering and current worker with potential beryllium exposure should re- ceive baseline medical screening that includes a questionnaire, chest radiogra- phy, spirometry, and the BeLPT. The questionnaire should include at least demographic information, lifetime workplace exposure history, smoking history, and history of respiratory and dermal disease and symptoms. The BeLPT test should be performed in accordance with the testing algorithm in Appendix B. BeLPT results from initial testing and any necessary retesting should be evalu- ated and recorded before a worker is allowed to begin work with potential expo- sure to beryllium. Outcome of Initial Medical Screening Initial findings of the questionnaire, chest radiography, and spirometry should be reviewed by an appropriately trained medical provider to determine appropriate job placement and medical followup. Results of the BeLPT test (ac- cording to the algorithm in Appendix B) will determine whether the worker is sensitized to beryllium. Those who are not sensitized and have no other findings of concern should be monitored regularly. The frequency of all screening meas- ures cannot be advised with confidence, because no studies have evaluated the optimal interval between screenings. Table 7-2 illustrates the measures that have been used for screening and the intervals used. For examples, the questionnaire has been administered at intervals of 3-12 months, and chest radiography at in- tervals of 1-3 years at different facilities. Similarly, the frequency of the BeLPT cannot be advised with confidence, because no published studies have addressed it. Some studies have identified development of BeS within 4-8 months of first beryllium exposure in new hires in some work settings, but the clinical impor- tance of detection at 4 months rather than at 1 year has not been determined. In the absence of a clear current estimate of risk in the Air Force, it is suggested that there be initial screening and that the frequency of repeat screening be guided in part by the extent of abnormalities detected. The frequency and extent of monitoring will probably depend on several factors, including information on exposure and the risk of BeS and CBD identified on initial screening. Initially, when there may be some uncertainty as to the risk to the workforce, it would be reasonable to consider annual medical monitoring for those with potential beryl- lium exposure. The data obtained from exposure assessment and medical moni- toring should be collected centrally and reviewed regularly to allow determina- tion of work areas and types of jobs carrying exposure risks and to allow some determination as to the degree of risks of BeS and CBD in exposed workers. Such knowledge should lead to better exposure controls and may allow modifi- cation of the program to optimize the frequency of medical monitoring and to

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138 Managing Health Effects of Beryllium Exposure determine the relative effectiveness of modes of screening. Others have sug- gested that the optimal frequency of medical monitoring may be between 1 and 5 years after the initial assessment (Maier 2001; Judd et al. 2003). BeLPT results that are not reported as normal should be addressed as out- lined in Appendix B. An abnormal BeLPT result, unexplained abnormalities seen in chest radiography or spirometry, unexplained respiratory symptoms, or other symptoms should lead to further medical assessment. Potentially, there can be an adverse effect on workers of almost any medical investigation, including emotional stress during a wait for test results. Identification of radiographic ab- normalities that may not have true clinical significance can lead to more inva- sive tests (such as bronchoscopy or open lung biopsy), which have associated risks. If a worker with evidence of BeS is undergoing further evaluation for pos- sible CBD, investigations would probably include full pulmonary-function tests and high-resolution computed tomography (HRCT) scans of the chest, which pose minimal risk. Bronchoscopy with bronchoalveolar lavage and biopsies poses greater risk and, although generally a sensitive method of diagnosing CBD, may not be appropriate or necessary for all workers with BeS. For exam- ple, a worker with an abnormal HRCT scan showing diffuse opacities or pulmo- nary-function abnormalities might, after evaluation of the risks and benefits re- lated to bronchoscopy, obtain a presumptive diagnosis without undergoing bronchoscopy. A worker with BeS who is asymptomatic and has normal pulmo- nary-function test results, carbon monoxide diffusing capacity, and HRCT may not want to undergo bronchoscopy, unless abnormalities are found in a regular followup. A worker with BeS or other medical screening results that suggest CBD should be offered removal from beryllium exposure (discussed further below). Outcome of Further Clinical Evaluation After the clinical evaluation, there are three possible outcomes: • No CBD and no BeS. These workers will be advised that they can con- tinue their previous jobs and have routine periodic medical screening. Other medical conditions (not related to beryllium) identified in the clinical evaluation should be managed as they would be for non–beryllium-exposed workers. • BeS but no CBD. There is insufficient evidence to determine clearly the effect of continuation of work in an area with potential beryllium exposure for those with BeS. Although BeS is a predictor of CBD, it is not known whether (and by how much) additional beryllium exposure increases the risk of progres- sion to CBD. That uncertainty should be communicated to a sensitized worker, who should be given the opportunity to work in areas without further beryllium exposure with medical removal protection. Workers with BeS who wish to con-

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139 Designing a Beryllium Exposure- and Disease-Management Program tinue to work in an area with potential beryllium exposure should be closely monitored to detect CBD. • CBD. Workers with CBD should discontinue work in areas that have beryllium exposure because of concern about worsening the disease. Although the effect of continuing exposure to beryllium at relatively low concentrations has not been clearly shown, the potential for CBD to become serious suggests that, given the current state of knowledge, it is prudent to avoid further beryl- lium exposure. Workers with CBD should continue to receive regular medical followup. Workers with CBD who discontinue work with beryllium should re- ceive medical removal protection. If workers understand the risk and elect to continue exposure, their exposure should be kept as low as feasible, and they should have regular medical followup and regular advice about the risk of dis- ease progression.