3
Impact of the NIOSH PPT Program

Assessing the impact of public health efforts is always challenging. Trying to gauge to what extent disease or injury is prevented or is minimized usually involves assessing multiple potential causes and an array of individual and environmental influences. For most public health concerns, multiple preventive measures contribute to protection against injury or disease, and determining the extent of attribution of any one preventive measure or action is complex.

Quantitatively determining the extent to which personal protective technologies (PPT) contribute to worker well-being is a difficult matter. Engineering and administrative controls play a significant role in preventing hazardous exposures. Additionally, because the use of PPT is an individual-based measure, with effectiveness determined in large part by user decisions and quality of the fit, there can be wide variation in the apparent effectiveness of PPT products in preventing illness or injury. The many types of PPT products (e.g., respirators, protective clothing, hearing protection, eye protection, gloves, shoes, helmets, fall protection) and the fact that PPT is used in numerous occupational settings, each with its unique exposures and workplace demands, create a further challenge in attributing the impact of the National Institute for Occupational Safety and Health (NIOSH) PPT Program’s efforts on improvements in worker safety and health.

This chapter begins with an appraisal of some of the external factors that affect the environment in which outcomes are attained. Several end outcomes are discussed in the chapter, with the focus of the text on the more tangible and identifiable



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3 Impact of the NIOSH PPT Program A ssessing the impact of public health efforts is always challenging. Trying to gauge to what extent disease or injury is prevented or is minimized usually involves assessing multiple potential causes and an array of individual and environmental influences. For most public health concerns, multiple preventive measures contribute to protection against injury or disease, and determining the extent of attribution of any one preventive measure or action is complex. Quantitatively determining the extent to which personal protective technolo- gies (PPT) contribute to worker well-being is a difficult matter. Engineering and administrative controls play a significant role in preventing hazardous exposures. Additionally, because the use of PPT is an individual-based measure, with effective- ness determined in large part by user decisions and quality of the fit, there can be wide variation in the apparent effectiveness of PPT products in preventing illness or injury. The many types of PPT products (e.g., respirators, protective clothing, hearing protection, eye protection, gloves, shoes, helmets, fall protection) and the fact that PPT is used in numerous occupational settings, each with its unique exposures and workplace demands, create a further challenge in attributing the impact of the National Institute for Occupational Safety and Health (NIOSH) PPT Program’s efforts on improvements in worker safety and health. This chapter begins with an appraisal of some of the external factors that affect the environment in which outcomes are attained. Several end outcomes are discussed in the chapter, with the focus of the text on the more tangible and identifiable 

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the peRsonal pRotectIve technology pRogRam nIosh at  intermediate outcomes of the PPT Program relevant to each of the major objec- tives. The chapter concludes with an overall assessment and scoring of the impact of the PPT Program. EXTERNAL FACTORS Determining the impact of the PPT Program1 is affected by a number of exter- nal and underlying factors. A prime underlying factor is the congressional mandate stipulating NIOSH’s responsibility to certify respirators. This chapter provides a more detailed discussion of the potential impacts of the certification mandate in providing the PPT Program with key oversight of the quality of respirators used in many U.S. worksites. The accompanying challenge, however, has been that respira- tor certification constitutes a significant percentage of the PPT Program’s budget. Further, the congressional requirements for respirator certification place this func- tion within the federal regulatory framework, which involves extensive procedures. Therefore, all changes to respirator certification regulations must go through a long process of federal rule making including publication, comment, and revision. This process ensures transparency to the general public but is time-intensive, particu- larly for dealing with products where the technology is evolving rapidly. The short duration of time since the inception of the PPT Program is a key external factor. Respirator certification has been conducted at NIOSH since 1972, and research and standards-setting efforts were occurring in other NIOSH divisions before being transferred to the National Personal Protective Technology Labora- tory (NPPTL). However, NPPTL was not founded until 2001, and therefore at the time of the writing of this report, barely seven years have elapsed. Given that the initial budgets in the early years of the laboratory were needed, to a large extent, for renovating the facilities, there have been only a few years on which to base an evaluation of the impact of the PPT Program. Further, NIOSH initiated the cross-sector PPT Program (NPPTL plus other PPT-relevant efforts) in 2005; this happened so recently that the PPT Program is just now having the opportunity to move beyond the initial organizational stages. Also important to recognize is the impact and relevance of global events to the use of PPT. The terrorist attacks of 2001, the mine disasters of 2006, severe acute respiratory syndrome (SARS), and the widespread concern about the potential for an influenza pandemic have all contributed to heightening the public’s awareness of PPT issues. These issues have all arisen amid the formative years of the PPT Program. 1As defined in Chapter 1, this report uses the term PPT Program to refer to the efforts from 2001 to the present that have been conducted by NIOSH relevant to the 12 PPT-relevant objectives that focus primarily on protection against respiratory and dermal hazards (Box 1-1).

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I m pac t nIosh ppt pRogRam of the  END OUTCOMES The majority of this chapter focuses on intermediate outcomes of the NIOSH PPT Program, because it is the intermediate outcomes that are more tangible and easier to quantify. However, the committee explored what could be said about the role of the PPT Program in impacting end outcomes, defined as reducing hazard- ous exposures and decreasing worker morbidity and mortality. PPT products are used extensively in the U.S. workplace, and many PPT prod- ucts have been found to be effective to varying degrees in reducing illness, injury, and death. As discussed in Chapter 1, estimates indicate that approximately 5 mil- lion U.S. workers are required to wear respirators in 1.3 million U.S. workplaces (OSHA, 2007). In situations, such as firefighting, where conditions can be of immediate danger to life, PPT effectiveness can be seen every day in the survival and lack of harm experienced by most firefighters throughout the nation. In 2006, firefighters re- sponded to 1,642,500 fire-related calls and suffered 44,210 injuries and 38 deaths due to operations at the fire site (NFPA, 2008a,b). A limited number of field studies of PPT have been conducted and provide evidence of the effectiveness of PPT products in the workplace. For example, a cohort of active firefighters in Boston followed for six years found that their longitudinal changes in pulmonary function were not correlated with a measure of firefighting exposure (Musk et al., 1982). Decrements in forced expiratory volume (FEV1) and forced vital capacity (FVC) were similar to levels in healthy nonsmoking adults. The authors attribute the lack of impact of long-term smoke exposure to increased use of PPT and to personnel selection factors. In a study of New York firefighters, researchers found that individuals who did not wear protective respiratory equipment had statisti- cally significant decrements in acute pulmonary function (Brandt-Rauf et al., 1989). Similar results were found in a study of the effectiveness of respiratory protection for coal miners in West Virginia (Li et al., 2002). The researchers found a significant protective association between self-reported use of respirators and pulmonary function (FEV1). Recently, Banauch and colleagues (2006) studied more than 12,000 New York City firefighters and found that decline in respiratory functions (FVC and FEV1) between 1996 and 2001 were no different than in the general male population (annual decrease of 31 mL per year). Protective clothing and hoods have also been found to reduce the incidence and severity of injuries due to burns experienced by firefighters. Rabbitts and col- leagues (2005) found a reduction in hospitalizations of firefighters due to burn injuries from 53 patients per year to 15 patients per year during a 10-year time frame. Because the incidence of structural fires did not decline during that period, improvements in protective clothing were suggested as a plausible explanation for the decline. Prezant and colleagues (1999) found an 85 percent reduction in

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the peRsonal pRotectIve technology pRogRam nIosh at 4 lower-extremity burn injuries, a 65 percent reduction in upper-extremity burn injuries, and a significant reduction in head burn injuries in New York City fire- fighters with the use of more protective uniforms and hoods. In January 2006, miners in the Aracoma Alma Mine in West Virginia used NIOSH/MSHA-certified self-contained self-rescuer (SCSR) respirators, which chemically generate breathable oxygen, in their successful escape from a hazard- ous mixture of dense smoke and deadly concentrations of carbon monoxide after a mine fire (MSHA, 2006). This successful effort was presumably due in part to proper training as well as to the availability and maintenance of effective escape respirators. MSHA and the PPT Program worked closely in the Aracoma investiga- tion to examine whether the escape respirators had been properly maintained and operable at the time of the fire. Contributing to these positive end outcomes are manufacturers, work site man- agers, individual workers, federal and state agencies, research programs, organizations and associations that set product standards and certify product effectiveness, and many others. The NIOSH PPT Program is a critical component of this effort. INTERMEDIATE OUTCOMES Goal 1: Reduce Exposures to Inhalation Hazards Although quantifying the impact of effective PPT on worker morbidity and mortality is challenging, a number of intermediate outcomes resulting from the work of the PPT Program point to progress. The major intermediate outcomes of the PPT Program are increases in the number of certified respirators, development and implementation of federal regulations and consensus standards, steps forward in increasing scientific knowledge regarding protection from inhalation hazards, and collaborations with other organizations and agencies. Respirator Certification Certified products The most significant outcome of the respirator certification program is an increase in the inventory of efficacious and reliable respirators for protection of workers from inhalation hazards. Since 2001, NIOSH has issued more than 1,600 respirator certifications (NIOSH, 2007a). NIOSH certification is the well- respected standard for asserting the efficacy of respirators. Both the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Admin- istration (MSHA) mandate that employers that have workers who may be exposed to respiratory hazards must use NIOSH-certified respirators (29 CFR 1910.34, 30 CFR 56.5005). Food and Drug Administration (FDA) approval of respirators for use

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I m pac t nIosh ppt pRogRam of the 5 in healthcare workplaces stipulates that the respirators must be certified by NIOSH (FDA, 2006). The Department of Homeland Security’s (DHS) Authorized Equip- ment List also stipulates the use of NIOSH-certified respirators. Federal grants used to enhance the capacity of state and local jurisdictions to prevent or respond to crises require that respirators purchased under such grants be NIOSH CBRN (chemical, biological, radiological, and nuclear)-certified (DHS, 2008). NIOSH certification is also a requirement for respirators used in Quebec, Canada (NIOSH, 2007a), and the British Standards Institute has adopted requirements specified in the CBRN respirator test methods and other parts of the CBRN standard. The actual inventory of NIOSH-certified respirators and respirator compo- nents in the United States is unknown to the committee. However, it is estimated that more than 5 million workers use respirators in the workplace. PPT Program staff members have reported a recent increase in applications for certification of N95 filtering facepiece respirators due to anticipated demand during an influenza pandemic (NIOSH, 2007a). The PPT Program is working to continue to improve its turnaround time in respirator certification with the goal of ensuring that the latest technology will be available for workers in the shortest reasonable time frame. Dissemination of information Communication of information is critical to the impact of the PPT Program, which places great emphasis on disseminating infor- mation related to the respirator certification program via public meetings, user notices and concept papers posted online, or publication of guidance documents and fact sheets for users and manufacturers (see Chapter 2). The dissemination of user notices of respirator certification recissions, recalls, or retrofits is particularly critical to ensuring that workers have effective equipment. The PPT Program has developed an extensive capacity to reach stakeholders through its listserv with up- dates on relevant research, policy and standards, and respirator certification activi- ties (NIOSH, 2008b). There are more than 2,500 listserv subscribers representing users, manufacturers, and stakeholders from 30 countries. Efforts have also been made by the PPT Program to provide a central online information resource site to respirator manufacturers with links to the certification application procedures, standard test procedures, Certified Equipment List, archives of letters to manufac- turers, and respirator user notices (NIOSH, 2008c). Other organizations are also disseminating information on NIOSH certifica- tion to the user community. For example, the Responder Knowledge Base (RKB) provides information to first responders (RKB, 2008). Sponsored by DHS, and in conjunction with the InterAgency Board for Equipment Standardization and Interoperability (IAB) and many partner organizations and agencies including NIOSH, the RKB is an online database of products that are in compliance with existing standards. The goal is an authoritative resource for equipment selection.

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the peRsonal pRotectIve technology pRogRam nIosh at  Products in the RKB are closely related to the DHS Authorized Equipment List (DHS, 2008) and the IAB’s Selected Equipment List, both of which specify NIOSH- certified CBRN respirators and compliance with NIOSH CBRN standards. Federal Regulations Respirators are the only type of PPT that is federally certified (42 CFR 84). Fed- eral regulations stipulate the specific test procedures and performance criteria for certification. Although updating the regulations through the federal rule-making process is a lengthy undertaking (see Chapter 2), once they have been finalized the PPT Program can implement the changes rapidly and use the revisions to further refine subsequent respirator certifications. The PPT Program’s work in the promulgation of CBRN regulations for respi- rator certification has had considerable impact on ensuring that these highly spe- cialized respirators meet specific criteria to offer effective protection to emergency workers and others with the potential for exposure. The Department of Homeland Security and the IAB have adopted the NIOSH CBRN respirator standards (IAB, 2007). National Fire Protection Association (NFPA) standards (NFPA 1500, 1991, and 1994) require NIOSH CBRN certification for self-contained breathing appa- ratus and air-purifying respirators. Internationally, the NIOSH CBRN respirator standards performance requirement and test methods have been incorporated by the British Standards Institute (NIOSH, 2007a). These achievements have been the result of activities that cut across the PPT Program. For example, as a result of the anthropometric research program, head and neck circumference data were used as a basis for the new NIOSH standard for CBRN escape respirators or hoods. Other federal regulatory standards are in various stages of development (see Chapter 2), and their implementation needs to be accelerated to the extent feasible under federal rule making. Proposed changes to the federal regulations, including tests of total inward leakage, could yield improved testing procedures and improved respirator performance if implemented. Consensus Standards The committee draft of the new International Organization for Standardiza- tion (ISO) specification standard (ISO 16976-2 Respiratory Protective Devices: Human Factors, Part : Anthropometrics) incorporates the findings of the initial PPT Program studies. PPT Program findings are also being used to establish the parameters for standardized headforms for respirator testing. The work that went into preparation of the Approaches to Safe Nanotechnology document (NIOSH, 2007c) by NIOSH has been incorporated into draft ISO and

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I m pac t nIosh ppt pRogRam of the  ASTM International standards that are working their way through those organiza- tions. The PPT Program has also proposed a new work item to the ASTM F23.40 Subcommittee based on the work done on viral decontamination (Test Method for Evaluation of the Effectiveness of Biological Decontamination Procedures on Viral Contaminated Air Permeable Material). Scientific Knowledge and Technology Transfer The various and disparate activities bundled together under the PPT respira- tory protection research program have, individually and collectively, resulted in significant advances in protection against respiratory hazards and exposures. The science that drives those advances is associated largely with the amount of resources devoted to the enterprise as well as the amount of time in which the PPT Program has been able to focus on the topic. For example, the contributions to scientific knowledge of the high-priority, decade-old program to develop CBRN respirator standards has clearly placed the PPT Program in a leadership role, and this leader- ship has played out in leading-edge contributions to national and international standards-development organizations. On the other hand, more recent—and less generously funded—projects to quantify the impact of PPE on viral transmis- sion and to evaluate respiratory protection against nanoparticles are in the early phases of research, and the scope of the PPT Program’s role in this area is still being explored. Projects to ensure the availability of improved mine emergency respirators, improve the reliability and level of protection of PPT by designs that better fit the users, and develop end-of-service-life indicator (ESLI) technologies have produced important, identifiable scientific advances although their promise still lies in the future. The PPT Program’s work on improving mine escape respirators is being ac- complished through efforts to explore new technologies, revise federal regulatory standards, and learn from field evaluations. This is a priority area for the PPT Program, but one in which resources are fairly limited (see Chapter 2). As noted above, NIOSH-certified SCSR respirators were instrumental in the safe rescue of miners in a West Virginia mine fire in 2006. Efforts to improve SCSR respirators are ongoing with a focus on developing technologies to provide an increased supply of breathable air that is accessible through multiple points along an escape route. The PPT Program is in the midst of expanding its Long-Term Field Evaluation of the emergency respirators to ensure a large enough sample for achieving statistical significance and to document corrective actions needed (NIOSH, 2007b). The PPT Program is working with a private-sector contractor to develop and test a prototype for a new dockable SCSR with the goal of extending the protection offered by these devices in the event of a disaster. The PPT Program has worked with MSHA to

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the peRsonal pRotectIve technology pRogRam nIosh at  refine training materials for SCSRs that include video- and computer-based train- ing focused on improving the efforts of mine workers in inspecting, maintaining, and using the respirators; the training modules have been distributed to more than 1,800 mines (NIOSH, 2007a). Studies in the laboratory have demonstrated the efficacy of respirators (for example, Coffey and colleagues, 1998a,b). The PPT Program’s research on im- proving respirator fit by beginning to examine total inward leakage (TIL) and utilizing anthropometric data will contribute significantly to scientific knowledge in this field through the development of new technologies and enhanced analytic methods. As recommended in the Institute of Medicine report on this research area (IOM, 2007) and further developed in the PPT Program’s action plan on an- thropometric research (NIOSH, 2008a), there are a number of ways to continue to refine research in this area. Also, as described in Chapter 4, the PPT Program has some initial plans to explore advances in materials sciences and other disciplines that may eventually lead to a respirator that fits all face shapes and sizes without the need for fit testing. The PPT Program’s research on viral transmission and protection in the event of pandemic influenza is still in the early phases but is pursuing answers to im- portant questions. PPT Program research in this area has resulted in further understanding of respirator decontamination, and efforts are under way to learn more about the viability of the influenza virus on PPT equipment. PPT Program scientists have provided their expertise to relevant national and international efforts on PPT and pandemic influenza, including a review of the U.S. national implementation plan at the request of the Homeland Security Council and input to the World Health Organization regarding the revision of its recommendations for respiratory protection during a pandemic (NIOSH, 2007a). The work on nanotechnology has had some early impact that sets the stage for further advances in the science. NIOSH and the DuPont Occupational Safety and Health Consortium have a memorandum of understanding (MOU) focused on work to examine test methods regarding the performance of protective cloth- ing and respirators exposed to nanoparticles. Ongoing work with the Center for Filtration Research at the University of Minnesota is also focused on respirator filtration efficiency against nanoparticles. The ESLI research program has made important contributions to worker safety by developing software models (distributed through OSHA’s website) that are used by employers to predict the service life of respirator cartridges. Previously, odor detection of gases or vapors by workers had been one of the methods used for de- termining service life. The OSHA requirement for a more accurate method (OSHA, 2008) and the PPT Program’s development of the MultiVapor and Breakthrough software (see Chapter 2) have improved the ability of employers to better protect

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I m pac t nIosh ppt pRogRam of the  workers from exposures to hazardous chemicals. The recent release of revised soft- ware allows temperature and humidity to be factored into the model and allows for consideration of chemical mixtures. The PPT Program needs to continue to make the models as user-friendly as possible and to continue to work with OSHA and employers to publicize the availability of the model. The ESLI sensor project to develop technology for incorporating sensors into respirator cartridges to determine their lifetime has a significant potential impact for all industries. This sensor technology measures the capacity of the cartridge or canister during use and alerts the user when the cartridge needs to be changed. The indicator can be an audio or a visual display and has numerous potential ap- plications in many industries because the technology is not contaminant-specific. The PPT Program is currently working with a group of manufacturers to test the sensor technology in a variety of simulated workplaces. Collaborations The PPT Program’s work on expediting the development of standards specific to CBRN respirators was based on extensive collaborations. Efforts began in 1999 with discussions at a workshop sponsored by NIOSH, the Department of Defense, and OSHA (NIOSH, 2007a). Early on, it was determined that the CBRN respirator standards development effort would also involve NFPA and the National Institute of Standards and Technology (NIST). Memoranda of understanding were put in place that defined each agency’s role, and the PPT Program worked extensively with these agencies as well as many others (including respirator manufacturers) to specify the hazards, define the operational requirements, and determine the protection requirements and standards. The PPT Program provided technical assistance to the Food and Drug Admin- istration in efforts to develop the new classification for respirators for the general public in the event of pandemic influenza (FDA, 2007). Further, the PPT Program has actively sponsored and participated in workshops on the topic of PPT for an influenza pandemic. These efforts include a January 2006 NIOSH conference Public Use of Respiratory Protection and a joint U.S. Department of Agriculture (USDA)- FDA-NIOSH interagency workgroup on PPT and other issues relevant to avian influenza in the workplace (NIOSH, 2007a). Research efforts to examine biocidal technologies and their use in respirators have involved developing MOUs with six respirator manufacturers. Collaborations with the Department of Veterans Affairs are focused on examining issues of comfort and wearability (NIOSH, 2007a). The PPT Program’s research into developing software models to predict the end of service life for respirator cartridges has involved multiple partners including the American Chemistry Council, the International Safety Equipment Association,

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the peRsonal pRotectIve technology pRogRam nIosh at 0 Los Alamos National Laboratory, the National Paint and Coatings Association, and others. More recent research efforts focused on the development of sensor-based approaches (to be embedded in the cartridge) are part of an active collaboration with the Microelectrical Systems Laboratory of Carnegie Mellon University and the U.S. Air Force. The current prototype system has been refined through five iterations of sensor design. Based on this collaborative research, the PPT Program has moved from basic research, to development of the sensor system, to actively working with manufacturers on testing these devices integrated into commercial respirators. As a part of the recent nanotechnology efforts, the PPT Program has collabo- rated extensively with other NIOSH colleagues in efforts to develop and implement the NIOSH strategic plan. Finally, the PPT Program works with MSHA to update the materials used to train miners in donning SCSR respirators. Committee’s Comments on Impact on Occupational Safety and Health As noted above, the NIOSH respirator certification program impacts worker safety by ensuring a reliable inventory of respirators for protection against re- spiratory hazards. Respirator manufacturers depend on NIOSH certification to independently evaluate the performance and quality of the products that they sell to employers. Further, the PPT Program’s efforts to reduce illnesses or injuries due to inhala- tion hazards can be seen through contributions to the development of standards, regulations, and research. However, the program’s impact could be even greater. Areas in which the impact of the respirator certification program could be im- proved include the following: • Registration of devices: The respirator certification and respirator pur- chasing processes do not currently have provisions for registering the purchase of respirators. As a result, neither NIOSH nor manufacturers have a direct method for contacting employers who purchased respi- rators with notices indicating that a problem or recall has occurred. MSHA has recently begun requiring registration of SCSRs by mine operators. • Field testing of certified respirators: Field tests of certified respirators are needed to ensure that these products perform effectively in the workplace. • Comparability of certification test results: Increasing the amount of certi- fication testing data provided online will allow purchasers, particularly employers, to learn more about these results and to compare products.

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I m pac t nIosh ppt pRogRam of the  • Expedited revisions of certification regulations: As detailed in Chapter 2, much needs to be done to ensure that federal regulations are updated to incorporate state-of-the-art technologies into the respirator certifi- cation process. The inhalation research program has begun to make significant contributions to worker protection from inhalation hazards in that it informs the certification program, provides information to manufacturers and employers that can assist in development of better protective equipment, and enables formulation of standards, both in the United States and abroad, that underpin inhalation PPT programs. In selecting the objectives for research programs to reduce exposure to inhalation hazards, NIOSH has appropriately focused on key issues of interest to the com- munity, such as pandemic influenza, as well as more specific projects to improve equipment (mine emergency respirators), add reliability (anthropometric fit), and ensure the continued effectiveness of equipment in the hands of users (end-of- service-life indicators). As these research programs move from basic to applied sciences, new questions have arisen and new avenues of investigation have opened. For example, the work on influenza virus protection has shown that the N95 disposable protective masks can prevent inhalation of the virus, but new questions about the ability of other types of equipment to protect against influenza have now been raised. In addition, there are questions related to reusability that require answers as to whether respi- rators once exposed to influenza can become infectious fomites for contagion. If so, reusability could not occur without an effective decontamination protocol. If not, reusability and a shift toward personal nondisposable respirators would make economic sense during a pandemic. Goal 2: Reduce Exposures to Dermal Hazards Although the NIOSH PPT Program does not certify PPT related to dermal ex- posures, intermediate outcomes of relevance include increases in scientific knowl- edge, technology transfer, and development of consensus standards. Scientific Knowledge and Technology Transfer The dermal component of PPT research at NIOSH is a relatively new addition to the portfolio and one that receives limited amounts of funding (approximately $765,000 in FY 2007; NIOSH, 2007a). However, even within these constraints, the PPT Program has advanced the scientific methodology and knowledge base on dermal protection. One of the important outcomes of PPT Program research in this

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the peRsonal pRotectIve technology pRogRam nIosh at  area has been the development of novel test protocols. As discussed below the re- search protocol developed by PPT Program staff in their work on testing firefighter ensembles is becoming a standard test method and can bring some consistency and comparability to PPE ensemble testing. Similarly, the stored thermal energy test apparatus, developed through research funded by the PPT Program, is being used for the interlaboratory testing conducted under the auspices of the NFPA Research Foundation through grants from DHS. The PPT Program’s work on cumulative permeation dermal risk assessment is a major step forward in addressing the many unknowns in this understudied area. Currently this research is largely confined to chemical warfare agents. However, it has potential for much broader impact when resources become available to expand the research focus to include protection against the many, and much more com- mon, toxic industrial chemicals found in the workplace. The establishment of physiological assessment facilities increases the national capacity for assessing these important performance attributes. Although the physi- ology laboratory is relatively new (established in 2005), this research facility offers the potential for significant contributions to the development of effective PPT that is less physiologically stressful and therefore easier for workers to tolerate. Physiologic and ergonomic studies conducted by the PPT Program have been an important part of Project HEROES® (Homeland Emergency Response Opera- tional and Equipment Systems), an effort designed to advance the technology of CBRN structural firefighting ensembles (IAFF, 2008). Researchers evaluated the effects of incorporated designs on the physiological burden of the turn-out gear developed by Project HEROES. Some of these advances included expansion of protective capabilities (CBRN), an innovative moisture barrier and gasket tech- nologies, advanced outer materials, and cooling systems for the upper torso. Although it is typically difficult to document the impact of forward strides in a rapidly evolving area of scientific knowledge, research conducted by the PPT Program often has applicability to the testing and development of protec- tive gear. These efforts have provided inputs to product specifications and ASTM International and NFPA standards revisions. Field assessments of chemical pro- tective clothing, gloves, and other types of dermal and injury-related PPT would be particularly helpful in broadening our understanding of these important and understudied areas (see further discussion in Chapters 4 and 5). Consensus Standards The PPT Program has made significant contributions to furthering standards relevant to protective clothing and other dermal protection. Through staff participa- tion in ASTM and NFPA technical committees and the supporting research efforts necessary to inform these efforts, the PPT Program has provided the information

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I m pac t nIosh ppt pRogRam of the  and expertise necessary to move forward on a number of new test methods and per- formance standards for PPT relevant to protective clothing and equipment (Table 3-1). Of particular note are NFPA 1971 and NFPA 1999. PPT Program personnel played key roles in the 2007 edition of NFPA 1971, Standard on Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting. Their efforts greatly assisted the development of the optional CBRN requirements. Additionally, the PPT Pro- gram has worked on the test methodology as well as the product evaluations for the revision of NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations. Further, the PPT Program sought input from a number of focus groups on this topic (NIOSH, 2007a). Overall, recent efforts by the PPT Program have contributed significantly to seven NFPA and two ASTM standards. TABLE 3-1 Recent Consensus Standards with PPT Program Involvement Date Standard 2005 NFPA 1991, Standard on Vapor-Protective Ensembles for Hazardous Materials Emergencies (2005 Edition) 2005 NFPA 1992, Standard on Liquid Splash-Protective Ensembles and Clothing for Hazardous Materials Emergencies (2005 Edition) 2007 PPT Program Physiological Protocol approved as an ASTM International standard practice for physiological evaluation of protective ensembles based on research conducted in the PPT Program laboratory 2007 ASTM F2588-06 Standard Test Method for Man-in-Simulant Test for Protective Ensembles 2007 NFPA 1951, Standard on Protective Ensemble for Technical Rescue Operations (2007 Edition) 2007 NFPA 1971, Standard on Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting (2007 Edition) 2007 NFPA 1994, Standard on Protective Ensembles for First Responders to CBRN Terrorism Incidents (2007 Edition) 2008 NFPA 1851, Standard on Selection, Care and Maintenance of Structural Fire Fighting Protective Ensembles (2007 Edition) 2008 NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations (2008 Edition) NOTE: ASTM = ASTM International (formerly, the American Society for Testing and Materials); NFPA = National Fire Protection Association.

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the peRsonal pRotectIve technology pRogRam nIosh at 4 The permeation calculator, developed through PPT Program research and analysis, is in the process of being incorporated into at least two ASTM standards as a tool for the calculation of permeation parameters from laboratory-based perme- ation test results. The calculated parameters are used to select appropriate chemi- cal protective clothing based on permeation resistance. As mentioned above, the protocol developed by the PPT Program for testing prototype firefighter ensembles through Project HEROES has recently been approved as Standard Physiology Test Practice (ASTM 23.60). This protocol sets the stage for further work on improving the ensembles by providing a consistent approach to testing and thus constitutes an important intermediate outcome that will require manufacturers to provide ensembles of equal protection. A valid and consistent testing method will enhance the reliability of the research-to-practice and technology transfer efforts. A number of stakeholders who spoke to the committee at its December 2007 workshop emphasized the valued contributions of PPT Program staff in providing leadership and expertise to a number of standards-development committees. One person noted that what previously had been a fairly passive level of involvement by PPT Program staff has now changed into an active contributory role. As seen in Table 3-1, PPT ensembles are a focus of efforts in standards setting. The committee strongly urges continued efforts to expand work on developing integrated PPT components. In the committee’s view, one of the efforts most needed in this field is progress toward protective equipment that is interchange- able, provides full coverage, and is consistent with ergonomics and human factors principles related to usability (see Chapters 4 and 5). PPT Program efforts also contribute to resources used by employers and employees. One of the outcomes of the PPT Program’s decontamination research is a contribution to the content of the American Industrial Hygiene Association (AIHA) guideline Decontamination of Chemical Protective Clothing and Equipment (AIHA, 2005). A PPT Program staff member, at the request of AIHA, served as the lead facilitator of the guideline development effort. The PPT Program also worked with AIHA to support research-to-practice activities by developing recommenda- tions for user practice. Committee’s Comments on Impact on Occupational Safety and Health Given the limited resources available for work on dermal PPT, the PPT Program has had, and continues to have, considerable impact. Foremost among the inter- mediate outcomes are the consensus standards that are developed and approved with substantive input from PPT Program staff and, in many cases, through research conducted or funded by the PPT Program. These standards provide the criteria for producing and testing high-quality and effective PPT. Recent efforts have focused

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I m pac t nIosh ppt pRogRam of the 5 on emergency responders, but with increased resources, similar steps forward could be taken on PPT for agricultural workers, healthcare workers, construction workers, and those in other occupations where the prevalence of toxic exposures and the large number of workplaces make this an important public health consideration. Goal 3: Reduce Exposures to Injury Hazards As discussed in Chapter 2, the committee was asked to look at only one PPT objective relevant to injury—the personal alert safety system (PASS) alarms that identify the location of a worker in distress. Work is in progress at NIOSH on PPT relevant to other injury hazards, particularly hearing loss, fall protection, and vibration protection. Those issues do not fall under the purview of this report but should be incorporated into the overall efforts of the expanded PPT Program discussed in Chapter 5. Work by the PPT Program and other NIOSH divisions through the investiga- tion of firefighter fatalities contributed to an alert published by NFPA focused on the potential failure of PASS alarm signals to operate at high temperatures (NFPA, 2007). PPT Program staff participated on the NFPA technical committee that re- vised the performance requirements. The resulting 2007 revised NFPA standard increased the temperatures and water immersion criteria used for testing these devices. Although this is currently a focused and limited area of ongoing effort in the PPT Program, there is great potential for further work on protective sensor technology (see Chapter 4). Surveillance The PPT Program’s surveillance efforts to date have focused on the use and dissemination of results of the 2001 NIOSH-Bureau of Labor Statistics (BLS) survey of respirator usage. The survey results were published in Respirator Usage in Private Sector Firms (BLS and NIOSH, 2003) and represent an advance in the nation’s understanding of employer practices with regard to respirator use as of 2001 (NRC, 2007). The survey’s findings were used extensively for the analysis of the regulatory impact of the proposed assigned protection factor (APF) rule of the OSHA 1910.134 respiratory protection standard (Steelnack, 2007). Also, as noted in the PPT Program’s evidence package, the survey enabled NIOSH, OSHA, and MSHA to better target workplace educational and information programs (NIOSH, 2007a). One key finding that a large number of establishments had airline respi- rator hose couplings compatible with other air or gas supply lines led OSHA to issue the Safety and Health Information Bulletin Deaths Involving the Inadvertent Connection of Air-line Respirators to Inert Gas Supplies (OSHA, 2004).

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the peRsonal pRotectIve technology pRogRam nIosh at  Several issues that limited the usefulness of the survey were reported in the NIOSH-sponsored National Research Council (NRC) report Measuring Respira- tor Use in the Workplace (NRC, 2007). The NRC report contained a number of recommendations for future survey and other surveillance activities and has had the positive impact of assisting in the development of a PPT Surveillance Program Action Plan (NIOSH, 2008d). This plan, available to the committee in draft form, specifies a number of short- and long-range activities for PPT surveillance to sys- tematically use data as an input to program decisions. In its draft form, the plan calls for the following: • A management framework that will closely align program mission, goals, and objectives with surveillance activities • A focus on PPT use and nonuse; defects, recalls, claims, and com- plaints; and information about injuries, illnesses, and deaths related to improper PPT design or use • An ongoing nationwide PPT survey conducted in each of the eight National Occupational Research Agenda (NORA) industry sectors,2 with one to three sectors (depending on size) surveyed each year • Special surveys conducted either as a supplement to the ongoing survey or independent from the ongoing survey to gather information on emerging issues, special needs, and specific study questions • Other data collection and analysis activities that will be based on secondary data sources, other databases, literature searches, and such activities as focus groups, panels, and field observations—these activi- ties would include developing an ongoing Demonstration and Sentinel Surveillance System for monitoring PPT-related efforts in five major hospitals; integration of the Long-Term Field Evaluation program of self-contained self-rescuers for miners into the surveillance program; and examination of other data sources, such as the Fire Fighter Fatality Investigation and Prevention Program, the National Electronic Injury Surveillance System, and the Sentinel Event Notification System for Occupational Risks • A research-to-practice plan to support these collection and analysis activities The draft timeline for implementing this plan envisions an ongoing exami- nation of secondary data sources, the conduct of special studies beginning in FY 2 The NORA industry sectors are Agriculture, Forestry, and Fishing; Construction; Healthcare and Social Assistance; Manufacturing; Mining; Services; Transportation, Warehousing and Utilities; and Wholesale and Retail Trade.

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I m pac t nIosh ppt pRogRam of the  2008, and a several-year buildup to the collection of the first sectoral surveillance surveys in FY 2011. The committee applauds the efforts of the PPT Program to bring scientific rigor to PPT surveillance, but remains concerned about acquisition of the resources required for such an undertaking. Further, the committee urges PPT surveillance efforts to focus on all types of PPT. OVERALL ASSESSMENT OF IMPACT NIOSH is nationally and internationally recognized for its respirator cer- tification program. OSHA and MSHA require that the respirators used in U.S. workplaces be NIOSH-certified. The PPT Program also took a leadership role in developing and expediting federal regulatory standards for CBRN respirators. This effort involved extensive collaboration with multiple federal agencies, manu- facturers, and professional associations (see Chapter 2). For example, OSHA and NIOSH collaboratively developed a CBRN PPT Selection Matrix for Emergency Responders (OSHA, 2005). Impacts on reducing hazardous exposures or preventing illness or injury are difficult to attribute directly to the work of a single federal agency. However be- cause the PPT Program certifies that respirators meet a number of rigorous, pre- specified performance criteria, the committee felt justified in acknowledging that positive end outcomes have occurred that are attributable to the PPT Program’s role in respirator certification. For workers who have few other protections from hazardous workplace exposures, such as firefighters, the value of effective PPT is a daily reality. As noted above, successful mine escapes have occurred because miners had access to effective respirators that prevented exposure to lethal levels of carbon monoxide. Having such equipment in place involves the collaborative efforts of manufacturers, professional associations, employers, employees, unions, state and federal agencies, and many others. However, the committee recognizes the central and vital role that the PPT Program plays in this effort. Important intermediate outcomes also appear to be the result of active partici- pation by PPT Program staff members in consensus standards-development efforts. The PPT Program has leveraged its limited resources well in its participation in na- tional and international consensus standards organizations. Several recent ISO and ASTM International standards have incorporated test methods developed through PPT Program research. The PPT Program staff has also led or been instrumental in research on a number of key issues, although, as in several other important areas, budget restraints substantially limit the extent of research efforts. Work on protec- tion against viral transmission (particularly related to pandemic influenza) and on nanotechnology is in the early phases and has not yet received the resources or had the opportunity to produce intermediate outcomes.

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the peRsonal pRotectIve technology pRogRam nIosh at  The committee believes that although great strides have been made in improv- ing respirators, much could be done to address other types of PPT (e.g., protective clothing, protective eyewear, gloves, hearing protection, hard hats, fall harnesses) with additional resources. Additionally, the successful focus on improving PPT for emergency responders now needs to be expanded to other occupations, including agricultural workers, construction workers, healthcare workers, and industrial workers, where the public health impact is likely to be far more substantial. Work on protective ensembles also holds great promise, and innovative approaches need to be developed to provide seamless interfaces among different types and compo- nents of PPT. As discussed in Chapter 2, the committee urges expedited efforts to revise federal certification regulations, so that new technologies and testing methodolo- gies can be utilized to improve the efficacy of respirators and allow for innovation in the design and function of this equipment. Similarly, there is much that should be done to improve protective clothing, eyewear, gloves, and other types of PPT, contingent upon additional resources. On the basis of its review of the PPT Program’s work in research, respirator certification, and policy and standards setting, the committee has assigned the NIOSH Personal Protective Technology Program a score of 4 for impact. This score, according to the scoring criteria outlined by the framework committee, reflects the judgment that the PPT Program has made probable contributions to end outcomes in addition to well-accepted intermediate outcomes (see Box 3-1 and Appendix A). In the judgment of the committee, the program could further improve its impact score by applying the lessons learned in the development of CBRN respirator stan- dards to other types of PPT (e.g., protective clothing, protective eyewear, gloves) BOX 3-1 Scoring Criteria for Impact 5 = The program has made major contribution(s) to worker health and safety on the basis of end outcomes or well-accepted intermediate outcomes. 4 = The program has made some contributions to end outcomes or well-accepted inter- mediate outcomes. 3 = The program’s activities are ongoing, and outputs are produced that are likely to result in improvements in worker health and safety (with explanation of why not rated higher). Well-accepted outcomes have not been recorded. 2 = The program’s activities are ongoing, and outputs are produced that may result in new knowledge or technology, but only limited application is expected. Well-accepted outcomes have not been recorded. 1 = Activities and outputs do not result in or are NOT likely to have any application.

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