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Evaluation of the Respiratory Diseases Research Program

The committee was charged with reviewing the Respiratory Diseases Research Program (RDRP) of the National Institute for Occupational Safety and Health (NIOSH) to evaluate the relevance and impact of its work to reduce workplace illnesses and injuries. The committee’s review focused primarily on 1996 to the present. This time period encompasses not only the current RDRP as it was established under the second National Occupation Research Agenda (NORA2) in 2005 but also occupational respiratory disease research as it was configured under the original NORA in 1996. The committee also notes selected activities related to respiratory disease research that occurred before 1996. As stated previously, the committee’s use of the term RDRP also indicates NIOSH activities and programs related to occupational respiratory diseases that predate formal creation of the RDRP under NORA2.

The committee evaluation followed the framework document, presented in Appendix A, developed by the Committee to Review NIOSH Research Programs and referred to as the framework committee. The framework document directs individual evaluation committees to evaluate program relevance in terms of the degree to which the research is connected to improvements in workplace protection. It identifies factors to be considered, including the frequency and severity of adverse health outcomes, the number of people at risk, the structure of the program, and the degree of consideration of stakeholder inputs. The framework document directs the evaluation committee to evaluate research impact in terms of the program’s contributions to improvement in worker health and safety to the



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2 Evaluation of the Respiratory Diseases Research Program The committee was charged with reviewing the Respiratory Diseases Research Program (RDRP) of the National Institute for Occupational Safety and Health (NIOSH) to evaluate the relevance and impact of its work to reduce workplace illnesses and injuries. The committee’s review focused primarily on 1996 to the present. This time period encompasses not only the current RDRP as it was estab- lished under the second National Occupation Research Agenda (NORA2) in 2005 but also occupational respiratory disease research as it was configured under the original NORA in 1996. The committee also notes selected activities related to respiratory disease research that occurred before 1996. As stated previously, the committee’s use of the term RDRP also indicates NIOSH activities and programs related to occupational respiratory diseases that predate formal creation of the RDRP under NORA2. The committee evaluation followed the framework document, presented in Appendix A, developed by the Committee to Review NIOSH Research Programs and referred to as the framework committee. The framework document directs individual evaluation committees to evaluate program relevance in terms of the degree to which the research is connected to improvements in workplace protec- tion. It identifies factors to be considered, including the frequency and severity of adverse health outcomes, the number of people at risk, the structure of the program, and the degree of consideration of stakeholder inputs. The framework document directs the evaluation committee to evaluate research impact in terms of the program’s contributions to improvement in worker health and safety to the 4

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 5 extent that it can be known or surmised in terms of quantifiable outcomes. This chapter presents the results of the committee’s review. RDRP GOALS, SUBGOALS, AND RESOURCES Since 2006, the RDRP has pursued the five strategic goals discussed in Chapter 1 with activities of different breadth. These goals are further subdivided into the subgoals shown in Table 2-1. NIOSH used these five strategic goals and their related subgoals to organize the primary evidence package and presentations provided to the committee. In turn, the committee used the five goals to organize its evaluation of the RDRP. While recognizing that the program did not directly use these goals during most of the period covered by the committee’s assessment, the goals are nonetheless consistent with priorities adopted by NIOSH throughout its history. These goals are also relevant for work related to the NORA priority areas of control technology and personal protective equipment, exposure assessment methods, and intervention effectiveness research. The following sections present the committee’s findings addressing both the overall program and matters concerning individual goals and their related subgoals. Funding for the program goals has varied over the past 10 years. Table 2-2 provides the budget for the RDRP classified by program goal. The largest frac- tion of the RDRP budget goes to airway diseases, followed closely by research budgeted for interstitial lung diseases. Table 2-2 also shows that malignancies and nanotechnologies are the smallest components, although spending on nanotech- nology research is rapidly increasing. Figure 2-1 shows a trend toward research in airway and interstitial disease and away from the study of occupational respiratory malignancies. ExTERNAL FACTORS AFFECTING THE RDRP The RDRP operates in an environment shaped by many factors that the pro- gram cannot control. Some factors are so fundamental to the nature of the program that the committee found it essential to keep them in mind for all aspects of its review. For example, NIOSH is primarily a research entity. Thus, although NIOSH can issue recommendations, it cannot mandate that such recommendations be implemented in the workplace. Regulatory implementation of NIOSH’s recom- mendations is left to the Occupational Safety and Health Administration (OSHA) or the Mine Safety and Health Administration (MSHA). Another important consideration is that the RDRP comprises a collection of activities that take place within the 11 organizational units of NIOSH shown in Table 2-3. The program is based on a matrix approach and does not reside within a

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at  TABLE 2-1 Strategic Goals and Subgoals of the NIOSH RDRP, as of February 2007 Strategic Goal : Prevent and reduce work-related airway diseases • Prevent and reduce asthma and allergy due to natural rubber latex among health care workers • Prevent and reduce WRA in the isocyanate production industrya • Prevent and reduce WRA related to nonindustrial indoor environmental quality • Improve detection of WRA and relevant exposures • Establish the work-relatedness of COPD • Develop tools and identify at-risk workers in industries and occupations to assess the extent, severity, and burden of work-related COPD • Develop, test, and disseminate recommendations for preventing COPD in the workplace. • Prevent and reduce flavoring related bronchiolitis obliterans Strategic Goal : Prevent and reduce work-related interstitial lung diseases • Prevent and reduce respiratory diseases induced by coal mine dust • Prevent and reduce silica-induced respiratory diseases • Prevent and reduce fiber-induced diseases • Prevent and reduce chronic beryllium disease Strategic Goal : Prevent and reduce work-related infectious respiratory diseases • Maintain reductions in the incidence of occupational tuberculosis in high-risk work settings • Protect workers from bioterrorism agents • Protect workers from occupational acquisition of emerging diseases (including severe acute respiratory syndrome, avian and pandemic flu) • Protect workers from occupational exposures that make them susceptible to respiratory infections • Prevent outbreaks of occupational histoplasmosis by maintaining worker and employer awareness Strategic Goal 4: Prevent and reduce work-related respiratory malignancies • Determine occupation etiologies of lung cancer • Reduce metal-induced lung cancer (hexavalent chromium) • Prevent and reduce silica-induced lung cancer • Prevent and reduce lung cancer induced by diesel engine exhaust • Produce lung cancer diagnostic tools Strategic Goal 5: Prevent respiratory and other diseases potentially resulting from occupational exposures to nanomaterials • Determine the relative toxicity of nanomaterials • Conduct exposure assessment and engineering control evaluations in 10 nanomaterial production or use facilities by 2008 • Produce dose-response data for carbon nanotubes sufficient to conduct a quantitative risk assessment by 2008 Abbreviation: WRA, work-related asthma. aBecause workers are exposed to isocyanates in a variety of industries besides isocyanate production, the goal should probably be worded “Preventing and reducing WRA associated with isocyanate exposure.” However, to be consistent with the NIOSH terminology, NIOSH’s original wording is used in this report.

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TABLE 2-2 NIOSH Respiratory Diseases Research Program Budget and Staffing by Research Goals (in Millions of Dollars) Total FY1996 FY1997 FY1998 FY1999 FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 Intramural 7.35 7.09 10.90 13.20 15.50 16.20 16.06 16.39 16.31 17.17 Extramural 2.31 3.08 4.51 7.31 7.29 8.61 10.08 10.30 8.64 11.40 14.50 Strategic Goal : Prevent and reduce work-related airway diseases Intramural 1.66 1.56 2.07 4.35 6.38 5.90 5.64 5.97 7.31 5.80 Extramural 0.62 1.51 2.37 3.13 3.72 3.42 3.10 2.83 2.52 2.74 2.94 Strategic Goal : Prevent and reduce work-related interstitial lung diseases Intramural 1.73 3.56 4.60 5.61 6.82 6.14 6.25 6.60 5.61 6.64 Extramural 0.08 0.08 0.35 0.70 0.65 1.48 0.92 1.09 0.38 0.68 0.38 Strategic Goal : Prevent and reduce work-related infectious respiratory diseases Intramural 2.89 1.74 3.57 1.89 1.40 3.10 3.63 3.05 2.45 2.70 Extramural 0.30 0.50 0.65 0.65 0.29 0.26 0.25 0.00 0.08 0.08 0.75 Strategic Goal 4: Prevent and reduce work-related respiratory malignancies Intramural 1.08 0.23 0.66 1.34 0.90 1.06 0.54 0.76 0.74 0.76 Extramural .043 0.19 0.09 1.68 1.68 1.19 1.25 1.91 1.78 1.40 1.35 Strategic Goal 5: Prevent respiratory and other diseases potentially resulting from occupational exposures to nanomaterials Intramural 0 0 0 0 0 0 0 0 0.67 1.27 3.31 Extramural 0.10 0.38 0.38 0.29 0.10 0.66 0.82 Abbreviations: FY, fiscal year; FTE, full-time equivalent. Source: R. Sinclair, NIOSH, unpublished material, April 7, 2007. 7

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at  Percent Total Intramural Fiscal Year 2-1.eps FIGURE 2-1 Proportional allocation of RDRP intramural funds by goal by fiscal year (FY). Source: R. Sinclair, NIOSH, unpublished material, April 7, 2007. bitmap w/ vector axis headers type is ~6 pt. specific division or laboratory on the NIOSH organizational chart (see Chapter 1). Although there is a Division of Respiratory Disease Studies, it is only one part of the RDRP, albeit the leading one. As with all 15 cross-sector programs under NORA2, a program manager and coordinator(s) are expected to monitor and guide the overall program effort. However, as described in Chapter 1, the organizational structure of NIOSH means that the program manager of the RDRP does not control the budget or the entire program portfolio. The program’s funding level is the sum of the financial resources that individual NIOSH organizational units apply to work on activities to monitor and prevent respiratory disease. The activities of the intra- mural program are distributed across units located in Morgantown, West Virginia; Pittsburgh, Pennsylvania; Cincinnati, Ohio; and Spokane, Washington. The selec- tion and management of extramural projects are based in Atlanta, Georgia. The portfolio, staffing, and funding levels for the RDRP also are shaped by congressional direction as to the amount of the NIOSH budget to be applied to pri- ority areas (e.g., mining safety and health). Although the NIOSH mining program no longer carries a separate line item in the federal budget, Congress has directed

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the  TABLE 2-3 NIOSH Divisions, Laboratories, and Offices Involved in the RDRP • Division of Respiratory Disease Studies • Health Effects Laboratory Division • Division of Surveillance Hazard Evaluation and Field Studies • Division of Applied Research and Technology • Education and Information Division • Pittsburgh Research Laboratory • Spokane Research Laboratory • National Personal Protective Technology Laboratory • Office of Extramural Programs • Office of Health Communications • Office of Research and Technology Transfer NIOSH to maintain its current level of research effort in this area. In practical terms, this means that, although the RDRP receives a percentage of its budget from the mining sector program, it does not have discretion to redirect these funds to any of the program’s other activities, which may need funding, unless there is a nexus with mine safety and health. SURVEILLANCE, HEALTH HAzARD EVALUATION AND TECHNICAL ASSISTANCE PROGRAM, AND OTHER INPUT ACTIVITIES There are several NIOSH programs that support all NIOSH activities, including those of the RDRP. These programs include surveillance activities, the health hazard evaluation and technical assistance (HHE/TA) program, emergency response and disaster preparedness tasks, and the respirator program. These elements serve as critical inputs into and support for the RDRP. Because they serve many different NIOSH activities, they are not evaluated under the program goals of the RDRP. However, it is important to note how these activities help serve the RDRP. Surveillance WoRLD Reports The information gathered through surveillance helps to identify and track occupational health and exposure. This information also can provide research directions and allow for assessment of trends and impacts. One prominent sur- veillance activity is the summary of occupation respiratory disease and associated exposure data in the series of Work-Related Lung Disease (WoRLD) Surveillance Reports and the web-based eWoRLD Surveillance System. The WoRLD Surveillance

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at 40 Report provides information on the frequency and trends in respiratory diseases, the industry and geographic distribution, and demographic information on those affected. Six of these reports have been released since 1991. As noted by NIOSH (2006a), the continuing challenge of such an undertaking not only is to maintain and update existing content but also to present the content in a meaningful way and to add new sources. This activity has also helped spur work in developing a standardized approach to mortality data on occupational lung disease. It has also helped give rise to NIOSH’s Worker Health Chartbook (NIOSH 2004). SENSOR Programs The SENSOR program attempts to integrate occupation health surveillance into public health activities at the state level. Using a consensus case definition of occupational asthma, SENSOR began as a sentinel event system based solely on vol- untary physician reports. It has evolved into efforts at the state level to enhance the population aspects of work-related asthma (WRA) surveillance including examina- tion of hospital discharge data and use of capture-recapture methodology. The state surveillance programs were intended to be targeted programs. At its inception in 10 states in 1987, 6 states identified WRA and 4 identified silicosis for surveillance. Currently, only 4 states continue WRA surveillance (Massachusetts, Washington, Michigan, and California) and 2 continue silicosis surveillance (Michigan and New Jersey). The need for appropriate surveillance data for WRA is critical. Without such data, the appropriate targeting of limited resources for exposure and medical moni- toring and interventions to prevent and control disease is difficult, if not impos- sible. The SENSOR program now has a presence in only four states. Expanding the program to include additional geographic areas, and thus the broader occupational mix, would provide a larger basis to track trends and to highlight geographic varia- tion. It is difficult to confirm from external material the NIOSH conclusion that the RDRP “indirectly supports 33 states, one city, and one territory to conduct surveil- lance for WRA.” While the National Center for Environmental Health supported state asthma plans and encouraged recipient state health departments to develop methods for WRA surveillance, a nationwide standard was not implemented and data formats and quality vary. Health Hazard Evaluation and Technical Assistance Program Under its “right of entry” authority, NIOSH investigates suspected hazardous exposures in the workplace. Such investigations, known as health hazard evalua- tions, take place under the HHE/TA program. These investigations are initiated by

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 4 requests from workers, from their representatives, or from an employer. Because of the importance and unique character of the HHE/TA program, it will be the subject of a separate National Research Council evaluation. This section focuses on the role of the HHE/TA program insofar as it interfaces with the goals of the RDRP. As noted later in this chapter, particularly with regard to activities related to airways and infectious diseases, the RDRP appears to have effectively used the HHE/TA program to inform and extend the research program on workplace envi- ronmental quality. For example, the HHE of the Missouri microwave popcorn plant, which investigated flavoring-induced bronchiolitis obliterans, gave rise to a coordinated research program on flavoring-related obstructive airway disease. The response to that specific HHE request can be considered a model of how the surveillance and initial data-gathering activities related to an HHE can be used as a key production input for setting priorities and planning research objectives. A more systematic approach to the review of all investigations in the HHE/TA program related to respiratory diseases might prove useful. For example, when the outbreak of flavoring-related bronchiolitis obliterans was followed up it was learned that an HHE a decade before had examined a similar work risk. No systematic assess- ment of HHE findings appears to be in place to identify other new occupational respiratory disease risks worthy of investigation. Similarly, the committee did not learn of any general review of reports in the HHE/TA program for WRA due to low-molecular-weight (LMW) or high-molecular-weight (HMW) sensitizers and irritants that induce new-onset asthma or for the discovery of agents that may cause work-related interstitial or airway disease, although NIOSH did undertake such a summary report with regard to isocyanates (Donovan Reh 2004). Dissemination of particularly relevant outbreak investigations pertinent to WRA or fixed-airway obstruction through mechanisms such as the Morbidity and Mortality Weekly Report (MMWR) or brief case reports in the peer-reviewed literature also could be carried out more effectively (e.g., glutaraldehyde in heart-valve manufac- turing workers, chlorine/sulfur dioxide/ozone in paper and pulp mill workers). A successful example of such dissemination by NIOSH was a report of a cluster of cases of new-onset asthma associated with exposure to 3-amino-5-mercapto-1,2,4-triazole identified through SENSOR (Hnizdo et al. 2004a) surveillance. Emergency Response As described in the evidence package, NIOSH participates in agency-wide responses to emergencies and catastrophes. These events include the World Trade Center disaster and anthrax attacks, responses to hurricanes Katrina and Rita, and responses to outbreaks of severe acute respiratory syndrome (SARS) and avian

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at 4 influenza in 2005. Activities related to emergency responses include immediate activities related to specific incidents and follow-up activities to further assess the impacts of these incidents and to help improve preparedness. Such activities are incorporated into RDRP program goals to varying degrees. For example, activities related to the goal of preventing and reducing work-related infectious respiratory diseases have been informed by the anthrax attacks of 2001 and outbreaks of SARS and avian influenza. However, no research activities related to emergency response and either WRA or chronic obstructive pulmonary disease (COPD) were reported in the airways disease section of the evidence package. Interestingly, the evidence package did not cite the ongoing medical monitoring of the World Trade Center disaster rescue and recovery workers as an example. This may reflect the somewhat compartmentalized organizational structure of NIOSH. It is unclear whether the RDRP plans to incorporate such research questions into future efforts, but such events could lead to coordinated activities between intramurally and extramurally funded NIOSH research programs. Respiratory Program Another critical element of NIOSH activities relevant to respiratory diseases is work related to respirators, including respirator policy. The evidence package provided by NIOSH (NIOSH 2006b) provides an overview of these activities, including the role NIOSH plays in having the lead responsibility for directing and carrying out the NIOSH respirator certification program and related laboratory, field, quality, and research activities. However, the integration of this activity with the program goals of the RDRP was unclear. For example, there was no discus- sion of airway-disease-specific respirator policy in the evidence package. However, NIOSH respirator development, testing, and certification efforts continue to play a crucial role in preventing both WRA and work-related COPD. The agency could better highlight the need for the respirator program by using the recent NIOSH peer-reviewed report supporting the use of respirators in emergency response situ- ations that involve exposures to irritant dust (Feldman et al. 2004). INTRODUCTION TO RELEVANCE AND IMPACTS ASSESMENT The following sections review the five NIOSH RDRP strategic goals and pres- ent the committee’s assessments with regard to the relevance and impacts of the research completed or in progress. The committee’s evaluation of NIOSH’s target- ing of new research is discussed in Chapter 3. At the end of the review of the five strategic goals, the committee provides a quantitative and qualitative evaluation of the relevance and impacts of the RDRP. In its evaluation of the relevance of

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 4 the work of the NIOSH RDRP, the committee has assessed the degree to which the program has led and carried out research in aspects of occupationally related respiratory disease most relevant to improvements in workplace protection. As discussed in Chapter 1, the committee evaluated the RDRP by using the evidence presented by NIOSH and other stakeholders, a review of the literature, and com- mittee members’ knowledge and experience in respiratory diseases. The committee developed a consensus through deliberations at meetings and discussions of written materials, including a lengthy scoring discussion. STRATEGIC GOAL 1: PREVENT AND REDUCE WORk-RELATED AIRWAY DISEASES Introduction Obstructive airway diseases as a group comprise the most prevalent type of occupationally related chronic respiratory disease. Moreover, the contribution of occupational factors to the incidence of obstructive airway diseases is well docu- mented. Thus, the overall goal of the RDRP airway diseases component to prevent and reduce work-related airway diseases is extremely important. The supporting materials the RDRP submitted to the committee underscore the importance of this goal to NIOSH. Our assessment focuses on the ways program development and associated resource allocation can optimize the efforts being expended to achieve this goal given its relative importance to the overall NIOSH agenda. The materials devoted to airway diseases submitted by NIOSH were organized into two major disease categories: WRA and fixed obstructive airway diseases (COPD and bronchiolitis obliterans). Four specific objectives were listed by NIOSH for each of these two categories. To facilitate review, the evaluation of the relevance and impact of the RDRP airway diseases component activities follows the same organizational scheme and addresses separately the subgoals for WRA and fixed airway obstruction as formulated by NIOSH. Nonetheless, it is recognized that no rigid boundary demarcates these two broad categories of obstructive airway disease and substantial overlap can occur. Work-Related Asthma NIOSH formulated the following four subgoals for WRA: • Prevent and reduce asthma and allergy due to natural rubber latex among health care workers. • Prevent and reduce WRA in the isocyanate production industry.

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at 44 • Prevent and reduce WRA related to nonindustrial indoor environmental quality. • Improve detection of WRA and relevant exposures. Ample rationale exists for including such specific objectives in an overall WRA program. The prevalence of sensitization to natural rubber latex among health care workers increased dramatically between 1987 and 1996 because of a huge increase in the use of latex gloves as part of the universal precautions for preventing exposure to blood-borne pathogens. Diisocyanates are one of the most common specific chemical causes of WRA and are used in a variety of settings and formulations. Indoor environmental quality complaints in general, and complaints specifically related to respiratory health (which include exacerbation of preexisting asthma), have led to multiple NIOSH HHEs. In response, NIOSH has developed considerable expertise related to WRA exacerbation in the context of indoor air, largely in the managerial and service sector, which is a dominant employment sector in postindustrial economies. The fourth, more general objective recognizes that improved surveillance for WRA is critical for identifying emergent problems, setting priorities, and tracking the effectiveness of interventions. The objectives as formulated have certain limitations. The objective related to latex asthma and allergy largely has been achieved. NIOSH deserves much credit for the documented reduction in WRA due to natural rubber latex, an end outcome among health care workers in the United States. The case for continuing this narrowly cast objective as a priority could have been more clearly elucidated. Latex is still used widely in applications far beyond the health care industry, such as day care and other service industries. Programmatic work on latex, a proto- typical HMW antigen, naturally extends to a variety of other important causes of WRA, such as enzyme and nonenzyme plant and animal proteins. This work also is relevant to work-related rhinitis, an airway disease apparently overlooked in the description of NIOSH goals. Similarly, the importance of diisocyanate-related asthma, a key prototype for asthma induced by LMW chemicals, goes well beyond the manufacture of this chemical (the focus of the NIOSH goal). In particular, diisocyanates are relevant to end-user sectors, especially in the construction industry. The mechanisms of immune response to these chemicals appear to differ in key ways from classic HMW sensitization, such as sensitization to latex, so the diisocyanate-specific goal may also be generalized to a far wider array of workplace LMW chemical hazards. For example, the challenges of elucidating mechanisms of disease in isocyanate- induced asthma may apply to other LMW chemicals. The NIOSH supporting materials only minimally addressed this subject.

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 0 effective in addressing complex issues related to methods to permit field assessment of low-level exposure to hexavalent chromium and relatively low-level exposure to diesel exhaust particulate matter. While the RDRP work on silica and respiratory malignancies has not penetrated as well into affecting agency rules and stakeholder practices, the reasons for this are beyond NIOSH’s control. Ongoing research continues to address some of the challenging problems related to occupational lung cancer risk. The RDRP has effectively engaged with stakeholders from both the workforce and the industry. This appears to be impor- tant in gaining acceptance of the research findings as well as adopting the methods and technology that were the subject of the research. It is important to note the unusual and successful efforts the RDRP has directed at informing, individually, all subjects of cohort studies about the findings from these studies and what meaning it could have to each worker. This attention to communicating to occupationally exposed populations is a model for investigators both within and outside government. The impact of the respiratory malignancies program is particularly strong in those specific areas where NIOSH applies its special expertise and mandate, comprehensively addressing specific carcinogenic exposures in the workplace. This strength is well demonstrated in the case of silica and chromium VI exposures. The work in diesel exposures has been completed, and it is expected to be integrated into this highly relevant exposure and risk assessment. The program components that address the contribution of occupational exposures to the burden of cancer in general are very significant. However, this contribution is not particular to respiratory cancers and it is unclear that the program is well served by separat- ing these particular outcomes from other important occupational cancer risks. Finally, the committee questions the specific relevance to the NIOSH mission of the research directed at diagnostic tools for early detection of lung cancer. While this area of investigation is relevant to lung cancer in general, there is little advantage of having this work located at NIOSH. Focusing the early detection biomarkers on workplace-specific prevention efforts would make these efforts more relevant to NIOSH’s mission and would increase the likelihood of the program’s having a significant impact. STRATEGIC GOAL 5: PREVENT RESPIRATORY AND OTHER DISEASES POTENTIALLY RESULTING FROM OCCUPATIONAL ExPOSURES TO NANOMATERIALS Introduction The overarching theme for the NIOSH Nanotechnology Research Program is to understand and prevent injuries and illnesses due to occupational exposure to

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at 0 nanomaterials in the workplace environment. This is a relatively new program that was implemented before any relationship was observed between nanotechnology and occupational lung disease. Thus, it is a proactive program rather than one that attempts to resolve problems after they have occurred. It includes specific concern with potential risks to the respiratory system as a natural extension of the previous research by NIOSH on the occupational hazards associated with inhaled dusts. NIOSH has indicated the following specific goals for the program: • To conduct research aimed at understanding and preventing work-related injuries and illnesses due to the use of nanotechnology products. This involves determining the toxicity of nanomaterials, identifying potential health outcomes from the use of these materials, and monitoring the health of individuals who work with these materials. NIOSH will also serve a major role in disseminating guidance information related to engineered nanomaterials. • To conduct research to prevent work-related injuries and illnesses due to the application of nanotechnology products. Nanotechnology-based sensors and communication devices may help in handling emergencies and in empowering workers to take preventive steps for reducing the risk of injury. Nanotechnology- based fuel cells, lab-on-chip analyzers, and optoelectronic devices have the potential to be useful in making the workplace safe and healthful. • To promote healthful workplaces through intervention, recommenda- tion, and capacity building. This involves developing and evaluating engineer- ing controls, personal protective equipment, and guidance on safe handling of nanomaterials. • To enhance global workplace health and safety through national and inter- national collaborations. This involves growing existing partnerships and developing new ones to identify research needs, approaches, and results to ensure worker health and safety. • Within the context of this program, the potential for disease and injury evaluated by NIOSH goes beyond just consideration of the respiratory tract. How- ever, because respiratory issues are highly integrated within the program as a whole, this section provides an assessment of the entire program and is not limited to respiratory outcomes. Planning and Production Inputs To help to achieve its goals, NIOSH has developed a strategic plan to guide the program. NIOSH is also working to coordinate its goals with other research groups, government agencies, and industries. To coordinate nanotechnology research within the Institute, the virtual Nanotechnology Research Center (NTRC) was established

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the  in 2004. The NTRC and its steering committee is composed of NIOSH scientists from various disciplines. The role of this committee is to develop and guide the Institute’s plan for health research related to nanomaterials in the workplace as well as to guide research on the application and utilization of nanomaterials in occu- pational safety and health. The project activities managed and coordinated by the NTRC contribute to several sector, cross-sector, and coordinated emphasis areas, including respiratory disease, manufacturing, exposure assessment, personal pro- tective technology, and engineering controls. In keeping with the NORA approach, the nanotechnology research program is managed across the Institute in a matrix fashion through NTRC. Various members of the nanotechnology research program meet annually to update strategic planning and to review the critical occupational safety and health issues arising from nanotechnology. The latter is a list developed by the NTRC to identify critical issues that may arise from nanotechnology in various areas, includ- ing exposure, toxicity, measurement, and control. NIOSH is a member of the Nanoscale Science, Engineering and Technology Subcommittee (NSET) of the National Science and Technology Council (NSTC) and participates in the National Nanotechnology Initiative (NNI) strategic and budget- planning processes. Through the NSET Nanotechnology Environmental and Health Implications Working Group, NIOSH coordinates research related to the occupa- tional health and safety of nanotechnology with other federal agencies. Activity, Outputs, and Outcomes As part of its nanomaterial research effort, in 2004, NIOSH funded the Nano- technology Safety and Health Research Program, which consisted initially of six research projects aimed at issues of exposure measurement, nanoparticle charac- terization, and biological effects of exposure in the pulmonary and cardiovascular systems. An additional four projects, aimed at issues related to exposure surveillance, exposure control, risk assessment, and risk dissemination, were added in 2005, and it is anticipated that a further increase in the research portfolio will be forthcoming to address issues of safe handling of nanomaterials, exposure mitigation, and toxicity to workers that may go beyond the respiratory tract as a target organ. Since this review began, an NTRC progress report for the years 2004-2006 has been released (NIOSH 2007e). The report lists 10 topic research areas that are the core of the NTRC research program to address occupational safety and health issues: toxicity and internal dose, risk assessment, epidemiology and surveillance, engineering controls and personal protective equipment, measurement methods, exposure assessment, fire and explosion safety, recommendations and guidance, communication and education, and applications.

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at  The NIOSH research program related to nanomaterials consists of intramural and extramural activities. Extramural funding for nanomaterial research began in FY2000, and these projects accounted for 3.1% of total extramural funding from that time to FY2006. Funding for extramural projects in FY2007 is lower than that in FY2006, at about $700,000. On the other hand, intramural funding has been increasing rapidly since 2003, and FY2007 funding is $4.6 million. Activities: Intramural Research Program The intramural program is concerned with determining nanomaterial expo- sure concentrations in occupational environments and potential adverse health outcomes from exposure as well as assessing appropriate engineering controls. These activities are reviewed and prioritized by the NTRC Steering Committee and are funded through various sources, including the NORA program, NTRC projects, and supplemental NORA funding. Several projects are listed in the “Strategic Plan for NIOSH Nanotechnology Research” (NIOSH 2005b) and in the recently released progress report (NIOSH 2007e). Funded projects include those on gen- eration and characterization of occupationally relevant airborne nanoparticles, pulmonary toxicity of carbon nanotube particles, the role of carbon nanotubes in cardiopulmonary inflammation and COPD-related diseases, particle surface area as a dose metric, ultrafine aerosols from diesel-powered equipment, nanotech- nology safety and health research coordination, nanoparticle dosimetry and risk assessment, nanoparticles in the workplace, web-based nanoinformation library implementation, an ultrafine particle intervention study in automotive production plants, and the filter efficiency of typical respirator filters for nanoscale particles. Given the diversity of types of nanoparticles that may be encountered in occupa- tional settings, it is likely that there will be quantitative and qualitative differences in the manner by which they may affect human health. Furthermore, a wide range of organizations are conducting research on the toxicity of various nanoparticles. Thus, it will be critical for NIOSH to prioritize the areas of research that are most important for its specific consideration. Activities: Extramural Research Program Extramural activities are aimed at supporting the strategic plan through research, education, and training. Some of these activities involve collaborating with other agencies, including the National Center for Environmental Research of the EPA, the National Science Foundation, and the National Institute of Environ- mental Health Sciences of the National Institutes of Health (NIH). As of FY2006, the extramural research project had funded seven projects. Some are joint solicita-

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the  tions from NIOSH and other funding agencies. The proposals are treated as NIH R01 or small business innovation research (SBIR) applications and are reviewed by the NIOSH study section. Research (R01) studies include assessment methods for nanoparticles in the workplace, monitoring and characterizing airborne carbon nanotube particles, lung oxidative stress/inflammation by carbon nanotubes, and the role of surface chemistry in the toxicologic properties of manufactured nanoparticles. Two SBIR studies were funded on new nanostructured sensor arrays for hydride detection and using nanoparticles in lightweight permeable textiles to improve the ability of protective garments to protect against toxic gases. There are also a number of cross-cutting projects that have some utility for evaluating risks from exposure to nanosized particles, although they may not be specifically engineered materials. Other Activities A number of activities serve to disseminate information about nanotechnology. They have often been produced in collaboration with NIOSH partners in nano- technology health and safety research. • NNI: NIOSH is a member of the NSET of NSTC and participates in the NNI strategic and budget-planning processes. Through the NSET Nanotech- nology Environmental and Health Implications Working Group, NIOSH coordi- nates research related to the occupational health and safety of nanotechnology with other federal agencies. • NIOSH cosponsored the International Conference on Nanotechnology Occupational and Environmental Health and Safety: Research to Practice in December 2006. This conference addressed the impact of nanotechnology on occupational and environmental health and safety from two perspectives: the promotion and protection of individual heath and safety along the life cycle of nanobased products, and the use of emerging technology in preventing, detecting, and treating occupational and environmental diseases related to nanomaterials. • NIOSH cosponsored an international symposium, Nano-Toxicology: Bio- medical Aspects, in January and February 2006. • NIOSH cosponsored the Second International Symposium on Nanotech- nology and Occupational Health in October 2005. • NIOSH cosponsored the First International Symposium on Nanotechnol- ogy and Occupational Health in October 2004. • NIOSH published the document “Approaches to Safe Nanotechnology” in 2005 with an update in 2006 (NIOSH 2006f) as an informational exchange to discuss health and safety concerns from exposure to nanomaterials.

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at 4 Outputs Safety Document NIOSH has published a highly requested document on “Approaches to Safe Nanotechnology: An Information Exchange with NIOSH” (NIOSH 2006f), which provides practical advice on the safe handling of nanomaterials by anyone working with the substances. NIOSH has a website to answer frequently asked questions. Research Publications NIOSH is just getting started in publishing in this emerging, fast-moving field. Three peer-reviewed articles were mentioned in the evidence package (Maynard and Kuempel 2005; Shvedova et al. 2005; Oberdorster et al. 2005). There were also six abstracts and six proceedings documents relating to manufactured nano- particles. The agency indicated a much higher number of publications, but they appear to be based on work with diesel particles, and not specifically with manu- factured nanoparticles. The recently released progress report of the NTRC indicates that the number of peer-reviewed publications has increased, with more abstracts and proceedings documents. Sponsored Conferences NIOSH has sponsored or cosponsored at least five nanotechnology conferences at the national and international levels. Invited Talks NIOSH staff have given about 50 invited talks on nanotechnology at national and international conferences. Outcomes This is a fairly new program for NIOSH so outcomes are limited. On an inter- mediate outcome level, an ISO Technical Committee on Nanotechnology that was established in 2005 has the United States as the leader in the committee’s Working Group on Health, Safety and the Environment.

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 5 Assessment of Relevance The nanomaterial research program, as outlined in the “Strategic Plan for NIOSH Nanotechnology Research-Filling the Knowledge Gaps” (NIOSH 2005b), is a highly relevant component of their overall research efforts. The research addresses an important and pressing need to determine the potential toxicity of and methods to monitor and control a newly discovered, highly useful material at the onset of its extensive use in industry. NIOSH has taken the initiative to develop a strategic plan to guide efforts and to allow more effective collaborations with other agencies both nationally and internationally. The focus of the NIOSH nanotechnology program is engineered nanoparticles, but the NTRC supports work within the Institute that can contribute to a better understanding of the behavior, measurement, toxicity, and control of other types of ultrafine particles such as those generated from occu- pational activities such as welding, diesel engines, and fires. Thus, the work in the nanotechnology program has implications for utility in other aspects of NIOSH. Assessment of Impacts This program is dealing with materials having a potential health effect, so measures of any reduction in health effects are not yet determinable. The expected impact is to prevent future health effects that might occur if this research were not done. The committee agrees that NIOSH is very proactive in this area of occupational health, helping to anticipate the need to protect occupationally exposed individuals. This proactivity is manifested both in the development of their research program on nanomaterials as well as in significant outreach as exemplified by publication of the “Approaches to Safe Nanotechnology” document (NIOSH 2006f). Successful development and implementation of this program will provide NIOSH with the opportunity to develop a paradigm to prevent occupa- tionally related illness due to exposure to nanomaterials before their widespread use in industry. This provides NIOSH with a unique opportunity to prevent dis- ease before it occurs rather than to control it after workers develop occupationally related pathology. Intermediate Impacts The NIOSH program should ultimately have an impact on setting federal regu- lations as well as voluntary and professional standards for handling nanomaterials. NIOSH is also having an impact on the education and training for monitoring and controlling nanomaterials in occupational settings. A major contribution of NIOSH to the latter was the timely publication of the document, “Approaches to Safe Nanotechnology: An Information Exchange with

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at  NIOSH” (NIOSH 2006f), a valuable guide for anyone working with nanomaterials. The leadership of NIOSH in developing this safety manual strongly influenced the appointment of the United States as chair of the Working Group on Safety and Health Standards of the International Standards Organization Technical Commit- tee on Nanotechnologies. NIOSH staff also have helped the EPA to develop a pilot program on the toxicity of nanomaterials and work with the National Institute of Standards and Technology to set standards for nanomaterials. NIOSH is a leader in providing forums for discussion of the potential health problems associated with the use of nanomaterials and has set up several confer- ences on the topic. The conference proceedings have been published and the impact of these conferences has been to stimulate further research in the field. NIOSH has interacted well with various stakeholders, including other government agencies and industry, to explore problems associated with nanotechnology. The output of the NIOSH basic research program on the toxicity of nano- particles in biological systems is less impressive in that only a few open literature publications have been completed. This probably reflects the newness of the field and the fact that NIOSH, with limited funds, has placed higher priority in areas where NIOSH is particularly well suited to have an impact—that is, in continuing successful research into methods to monitor exposures to nanomaterials and to develop appropriate engineering controls to prevent such exposures. The com- mittee thinks this is appropriate because many other agencies, particularly NIH, are conducting basic research on the health effects of engineered nanomaterials. Nevertheless, the committee encourages continued research efforts on the toxicity of nanomaterials in biological systems as a part of the RDRP program (see emerg- ing issues section). One listed goal is to explore how various applications of nano- materials might improve workplace safety. This is a limited program confined to a few SBIR extramural projects. The committee agrees that this area should not have a high priority for the RDRP. End Impacts It is not possible at this time to assess end outcomes since nanotechnology is a fairly new field and occupational disease has not yet been attributed to exposure to nanomaterials. However, the use of manufactured nanomaterials is expected to grow, and the available database from toxicology studies suggests that nanoparticles may be a potential occupational health hazard. Since there is a potential impact on thousands of workers, it is admirable that NIOSH has taken the lead before development of disease in the workplace; by continuing a leadership role, NIOSH has had and will have a major influence on policy setting.

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the 7 OVERALL ASSESSMENT OF THE RDRP RELEVANCE AND IMPACTS A central part of the charge to the committee is to provide a quantitative assessment of the overall relevance and impacts of the RDRP’s activities. Using scoring criteria the National Research Council framework committee developed, the committee was tasked with rating the relevance of the RDRP’s activities for improving occupational health on a scale of 1 (lowest) to 5 (highest) and rating the impacts of the program’s research for reducing work-related hazardous exposures and illnesses on a similar scale. Box 2-1 shows the scoring criteria for relevance and impacts, which was also shown in Chapter 1. To develop scores for the program as a whole, the committee considered its assessment of the relevance and impacts of NIOSH activities directed at the indi- vidual program subgoals described previously. It then weighted these qualitatively to arrive at an overall program assessment. The framework committee recognized the substantial differences among the types of research programs that will be reviewed by the various evaluation committees. It thus declined to provide an explicit instruction on how an evaluation committee should implement the scoring system and weigh the various programs and instead called for individual commit- tees to use their expert judgment to develop its scores. Relevance Score As noted earlier, the RDRP is a large program, using nearly $30 million in 2005 in pursuit of its program goals and subgoals. Not surprisingly, the committee found variability in the degree to which individual activities might be relevant to the overall program goals of the RDRP. For example, although the individual activi- ties related to indoor air quality likely contribute to better overall understanding of this issue, their relationship to occupational asthma is not necessarily straight- forward. However, there are clearly a large number of programs that are directly relevant to the individual goals. It also is important to note how some activities, especially those that occur outside the Division of Respiratory Disease Studies, may have other NIOSH goals as their primary motivators. For example, RDRP-related activities that occur at the Pittsburgh Research Laboratory must also be relevant to NIOSH’s goal of improving mine safety and health. The committee has assigned a score of 5 in its rating of relevance. This reflects the judgment of the committee that the activities related to most of the subgoals are in the highest-priority subject areas and highly relevant to improvements in workplace protection and that the RDRP is engaged in transfer activities at a sig- nificant level. This is particularly true for its activities related to interstitial lung disease as well as many parts of the activities related to airways and infectious

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r e s P i r ato ry d i s e a s e s r e s e a r c h niosh at  BOX 2-1 Scoring Criteria for NIOSH Program Reviews from Framework Document Rating of Impact 5 = Research program has made a major contribution to worker health and safety on the basis of end outcomes or well-accepted intermediate outcomes. 4 = Research program has made a moderate contribution on the basis of end outcomes or well-accepted intermediate outcomes; research program generated important new knowledge and is engaged in transfer activities, but well-accepted intermediate out- comes or end outcomes have not been documented. 3 = Research program activities or outputs are going on and are likely to produce improve- ments in worker health and safety (with explanation of why not rated higher). 2 = Research program activities or outputs are going on and may result in new knowledge or technology, but only limited application is expected. 1 = Research activities and outputs are NOT likely to have any application. NA = Impact cannot be assessed; program not mature enough. Rating of Relevance 5 = Research is in highest-priority subject areas and highly relevant to improvements in workplace protection; research results in, and NIOSH is engaged in, transfer activities at a significant level (highest rating). 4 = Research is in high-priority subject area and adequately connected to improvements in workplace protection; research results in, and NIOSH is engaged in, transfer activities. 3 = Research focuses on lesser priorities and is loosely or only indirectly connected to workplace protection; NIOSH is not significantly involved in transfer activities. 2 = Research program is not well integrated or well focused on priorities and is not clearly connected to workplace protection and is inadequately connected to transfer activities. 1 = Research in the research program is an ad hoc collection of projects, is not integrated into a program, and is not likely to improve workplace safety or health. diseases and malignancies. The committee also noted that the activities related to nanotechnology were highly relevant, even though this emerging area has yet to see any impacts related to intermediate or end outcomes. Activities related to parts of some subprograms, including some of the activities related to malignancies and infectious diseases, do not reach this highest level of relevance as reflected in the assessment of the subprograms earlier in this chapter. But those NIOSH activities

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e va l u at i o n r e s P i r ato ry d i s e a s e s r e s e a r c h P r o g r a m of the  were still in important research areas with some connection to improvements in workplace protection. Impact Score There is variability in the impacts of RDRP activities on end outcomes or well-accepted intermediate outcomes. Some activities may have large and well- documented impacts, whereas others are smaller and less easily discernable. Again, given the size of the RDRP and the notion that some elements of the RDRP have objectives besides respiratory diseases, the outcome is not surprising. For example, the committee notes that activities related to the development of diagnostic tools for early detection of lung cancer, while relevant to lung cancer in general, have no effect on the program goal associated with work-related respiratory malignan- cies. The committee recognized that, in terms of assessing measurable impacts, any programmatic efforts of only 10 years’ duration could not be expected to be reflected in changing incidence data for respiratory tract diseases with long latency, most notably respiratory tract malignancies. Thus the absence of data for indicating such impacts was not weighted as a “negative” finding. Where appropriate, however, exposure or other risk factor reductions for disease processes with long latencies were considered. Further, there is no way for NIOSH to quantify specifically the impacts that work on personal respirators and environmental controls have had on reductions in the occurrence of TB and other respiratory infections. However, the activities of the RDRP have clearly played major roles in reducing the occurrence of and mortality from CWP. It also played a major role in reducing the prevalence of latex sensitization as a result of the intervention effort that began with the 1996 NIOSH Alert. The committee has assigned a score of 4 in its rating of impact, reflecting the committee’s judgment that most of the subprograms within the RDRP have made major contributions to worker health and safety on the basis of end and well- accepted intermediate outcomes. It represents the consensus of the committee on the degree to which the overall program, which is still in its infancy, meets the goals and has had the impacts set out by NIOSH. After much deliberation on how to weigh the assessments of different subprograms, the committee assigned a score of 4 for the program as a whole. Had the committee been given the option of provid- ing non-integer scores, the score for program impact would have been between 4 and 5, based on consensus that the program was clearly better than that called for in a score of 4 but not in sum what the committee would rate a 5.