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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 40
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 49
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 50
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 51
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 52
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 53
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 56
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 57
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 58
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 59
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 60
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 61
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 62
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 63
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 64
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 65
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 66
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 67
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 68
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 69
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 70
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Page 71
Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Suggested Citation:"2 Relevance of the NIOSH PPT Program." Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. doi: 10.17226/12203.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

2 Relevance of the NIOSH PPT Program T he committee began its assessment of the relevance of the Personal Protec- tive Technology (PPT) Program of the National Institute for Occupational Safety and Health (NIOSH) by looking at the resources available to the program, the decisions and priorities set by the program, and the products and other outputs and transfer activities that have resulted from the efforts of the PPT Program since 2001. This chapter begins with an overview of the program’s current resources and interactions, followed by a detailed analysis of the relevance of the PPT Program’s efforts in addressing its goals of reducing exposures to inhalation, dermal, and injury hazards through PPT. The chapter concludes with a summary assessment of the relevance of the PPT Program. As discussed in Chapter 1, the committee was asked to assess the work of the NIOSH PPT Program relevant to 12 objectives. Other National Academies’ reports (IOM and NRC, 2006; NRC and IOM, 2007, 2008a,b) have examined NIOSH pro- grams on hearing loss, mining, and respiratory disease, which encompass related PPT elements. Additional National Academies’ reports on NIOSH’s construction, traumatic injury, and health hazard evaluation programs will also be relevant.   As 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). 34

R e l e va n c e of the N I OSH PPT P r o g r a m 35 OVERVIEW OF PPT PROGRAM RESOURCES Funding and Staffing Since its initial funding in FY 2001, the PPT Program’s annual budget has ranged from $8.6 million to $12.2 million with additional funding sources adding between $1.3 million and $8.8 million (Figure 2-1). These figures do not encom- pass PPT-relevant work on hearing loss, fall protection, and antivibration gloves. Extramural research funding is provided through the NIOSH Office of Extramural Programs (see below). The PPT Program’s funding from external sources, which totaled $1.3 million in FY 2007 but was as high as $8.8 million in FY 2003, has been largely targeted at PPT for first responders in the event of a terrorist attack. These activities also included the development and implementation of federal regulations to certify respirators designed to reduce exposures to chemical, biological, radiological, and nuclear (CBRN) hazards. Sources of external funding for this project included the National Institute of Standards and Technology (NIST), the Department of Homeland Security, and the U.S. Department of the Navy. In recent years, both external funding and the PPT Program’s budget have simultaneously declined (Figure 2-1; Table 2-1). $20.00 $18.00 $16.00 $1.32 $3.93 $2.83 $14.00 $3.62 $8.85 $5.58 $1.85 $12.00 $ Millions $10.00 $8.00 $12.26 $12.20 $11.79 $11.25 $6.00 $9.12 $8.59 $8.62 $4.00 $2.00 $0.00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 Fiscal Year Direct Base Allocation Outside Funding Sources FIGURE 2-1  PPT Program funding by year and source (million dollars). SOURCE: NIOSH, 2007a. Figure 2-1.eps Type is < 7-point

36 TABLE 2-1  PPT Overall Budget Summary FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 Total Direct budget allocation $8,616,297 $9,116,297 $8,593,373 $11,248,770 $12,200,070 $12,259,922 $11,787,202 $11,779,970 $85,601,901 External funding $1,847,519 $5,576,000 $8,850,760 $3,616,139 $3,933,314 $2,826,992 $1,317,002 $148,094 $28,115,820 Total $10,463,816 $14,692,297 $17,444,133 $14,864,909 $16,133,384 $15,086,914 $13,104,204 $11,928,064 $113,717,721

R e l e va n c e of the N I OSH PPT P r o g r a m 37 $8.00 $7.00 $6.00 $5.00 $ Millions $4.00 $3.00 $2.00 $1.00 $0.00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 Fiscal Year Respirator Policy and Research Physical Outreach Evaluations Certification Standards Infrastructure Development FIGURE 2-2  PPT Program budget FY 2001-2007. SOURCE: NIOSH, 2007a. Figure 2-2.eps To gain further insights into the allocation of the funding resources, the com- mittee also examined annual funding levels by objective and by use (Table 2-2 and Figure 2-2). In the first three years of the National Personal Protective Technology Laboratory (NPPTL) (FY 2001 to FY 2003), significant resources were needed to renovate the laboratory and office space. Recent changes have allocated increased resources for outreach and for evaluation. Several segments of the PPT Program budget are dedicated to specific activities (NIOSH, 2007a). Evaluation efforts (e.g., National Academies’ evaluations, peer reviews, customer satisfaction surveys) are protected activities addressing issues relevant to all areas of the research, standards-setting, and certification efforts. Similarly, the PPT Program dedicates resources to its research-to-practice (r2p) activities to ensure that the results of its scientific activities in the laboratory can be translated into efforts to improve workplace safety. Initial staffing in the first year NPPTL was created included 19 full-time equiva- lent (FTE) personnel from existing NIOSH divisions and 11 competitive hires from other government agencies, academia, and private industry. By FY 2007, PPT Program staffing stood at 61 FTE federal employees (Table 2-3). The distribution of the expertise of the FTE positions at NIOSH emphasizes the applied science   A NIOSH initiative focused on the transfer and translation of research findings, technologies, and information into effective prevention practices and products that can be adopted in the workplace.

38 TABLE 2-2  Breakdown of the PPT Program Budget by Objective PPT Program Objective FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 Total Percentage Dermal Objectives Protective clothing tests $778,074 $747,360 $493,294 $688,051 $746,998 $638,186 $198,683 $153,852 $4,444,498 3.9 Emergency responders $0 $0 $0 $0 $290,950 $182,584 $203,225 $96,828 $773,587 0.7 Physiological impact $0 $496,403 $1,273,489 $600,373 $683,919 $992,351 $740,412 $947,738 $5,734,685 5.0 Injury Objective PASS warning devices $720,987 $318,529 $503,517 $324,497 $546,519 $113,243 $176,453 $69,681 $2,773,426 2.4 Inhalation Objectives Certification $3,095,419 $3,797,557 $2,316,706 $5,186,286 $4,340,557 $4,570,614 $6,392,211 $5,845,022 $35,544,372 31.3 CBRN $2,873,300 $6,084,128 $10,401,677 $5,282,899 $6,411,547 $4,411,428 $1,258,337 $1,612,456 $38,335,772 33.7 Mining $1,464,746 $1,007,911 $697,199 $949,245 $447,403 $235,194 $1,681,040 $602,256 $7,084,994 6.2 Anthropometrics and TIL $1,012,158 $676,597 $513,880 $381,632 $1,277,875 $600,014 $291,964 $781,938 $5,536,058 4.9 Viral transmission $0 $0 $0 $0 $0 $1,463,738 $777,552 $481,139 $2,722,429 2.4 Nanotechnology $0 $0 $0 $0 $0 $310,175 $325,351 $319,111 $954,637 0.8 ESLI $0 $1,323,477 $931,980 $1,131,645 $1,120,658 $1,294,696 $688,003 $620,891 $7,111,350 6.3 Surveillance $519,131 $240,335 $312,390 $320,283 $266,959 $274,690 $370,974 $397,154 $2,701,916 2.4 Total $10,463,815 $14,692,297 $17,444,132 $14,864,911 $16,133,385 $15,086,913 $13,104,205 $11,928,066 $113,717,724 100.0 NOTE: ESLI = end-of-service-life indicator; PASS = personal alert safety system; TIL = total inward leakage. This table breaks down the PPT Program’s annual budget by program objective. Overarching costs are spread across all goals by percentage. Overarching costs include funding for the Office of the Director; personnel, services and benefits; Quality of Science initiatives (National Academies reviews, IOM standing committee); APEX (Achieving Performance Excellence) activities; and outreach activities. For example, in this table the 31.3 percent of the budget allocated for certification activities includes 31.3 percent of the overarching costs described above. SOURCE: NIOSH, 2008d.

TABLE 2-3  Staff Allocations (FTE) by PPT Program Objectives Objectives FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 Total Dermal Objectives Protective clothing tests 3.20 4.19 3.24 3.21 2.52 1.52 1.10 0.85 19.83 Emergency responders 0.00 0.00 0.00 0.00 0.30 0.56 1.85 0.45 3.16 Physiological impact 0.00 0.36 1.14 1.75 3.45 2.51 1.04 3.26 13.51 Total 3.20 4.55 4.38 4.96 6.27 4.59 3.99 4.56 36.50     Injury Objective   PASS warning devices 0.09 0.67 0.75 1.22 1.32 0.75 0.86 0.61 6.27     Inhalation Objectives Certification 14.48 24.35 21.56 26.46 31.49 29.33 33.13 38.03 218.83 CBRN 13.32 15.03 16.59 13.70 18.81 13.90 7.84 11.54 110.73 Mining 4.54 6.52 4.35 4.64 1.88 1.50 4.23 3.61 31.27 Anthropometrics and TIL 1.46 3.90 3.80 2.26 3.57 3.99 1.75 3.41 24.14 Viral transmission 0.00 0.00 0.00 0.00 0.00 1.20 4.32 3.42 8.94 Nanotechnology 0.00 0.00 0.00 0.00 0.00 1.23 1.19 1.02 3.44 ESLI 0.00 1.18 1.46 1.75 2.45 1.78 2.04 2.00 12.66 Surveillance 0.97 1.27 2.06 2.19 1.63 1.72 2.07 2.13 14.04 Total 34.77 52.25 49.82 51.00 59.83 54.65 56.57 65.16 424.05 PPT Program Total 38.06 57.47 54.95 57.18 67.42 59.99 61.42 70.33 466.82 NOTE: ESLI = end-of-service-life indicator; PASS = personal alert safety system; TIL = total inward leakage. SOURCE: NIOSH, 2008e. 39

40 The Personal Protective Technology Program at N I OSH n ­ ature of the work. In FY 2007, the FTE positions were primarily in the engineering, physical sciences, and quality assurance fields. The PPT Program has one full-time epidemiologist on staff. NIOSH staff members in other offices and divisions can collaborate on PPT Program projects. Facilities The PPT Program is administered through NPPTL, with the main campus lo- cated outside of Pittsburgh, Pennsylvania, at the Bruceton Research Facility. At the Bruceton location, the PPT Program’s work is spread throughout 26 laboratories and testing facilities. These facilities include climatic chambers, flammability and vibration testing machines, an anthropometrics research laboratory, and a recently added human research physiology laboratory. A recent renovation expanded the fit test laboratory to allow for total inward leakage (TIL) assessment as a part of quantitative fit testing. The current laboratories are housed in renovated buildings. In 2002, soon after NPPTL was established, a development study was undertaken to explore the needs and costs of developing the laboratory and administrative space needed to fulfill the congressional mandate for the PPT Program. The goals of the consolidation effort were to “improve communication among researchers, centralize related projects, and thus improve program efficiency” (Jacobs Facilities, 2002). The development study explored program and space requirements. In 2002, the total costs of building and implementing an approximately 122,700 square foot facility were estimated at $91 million (Jacobs Facilities, 2002). An update of the development plan was conducted in 2006. Unfortunately, the original concept of a unified laboratory with modern space has not been realized, and the current configuration of the disparate laboratories largely isolates researchers from each other and is counterproductive to collaborative research efforts. The facilities that house the work of some of the other PPT components in NIOSH include auditory research laboratories in Pittsburgh and in Cincinnati, Ohio; an anthropometry laboratory that examines the ergonomic performance of safety equipment and industrial tools in Morgantown, West Virginia; and a human performance research laboratory at Pittsburgh Research Laboratory. Extramural Research The NIOSH Office of Extramural Programs administers the investigator- i ­ nitiated extramural program. Grant applications are reviewed through scientific review groups (study sections) managed by scientific review administrators at NIOSH or in the Center for Scientific Review at the National Institutes of Health

R e l e va n c e of the N I OSH PPT P r o g r a m 41 (NIOSH, 2008l). Of the nine identified extramural projects with ongoing work relevant to PPT, two grants support work in agricultural safety and health centers and one supports work on construction safety (Table 2-4). PPT Program staff re- ported that they are working to develop an improved strategy for using the output of the extramural research program as input to the planning and priority-setting processes of the relevant components of the PPT Program (NIOSH, 2007a). Efforts to more fully engage the extramural research community are needed. A variety of options exist including research centers of excellence (Chapter 5), coop- erative agreements, small business innovation research (SBIR) programs, and small business technology transfer (STTR) programs. The PPT Program should take as active role a role as possible in developing extramural research and encouraging these researchers to explore innovative approaches to improving PPT. GOAL 1: REDUCE EXPOSURES TO INHALATION HAZARDS Respirator Certification A major factor in reducing worker exposure to inhalation hazards is ensuring that respirators effectively protect the user. Respirator certification is a congres- sionally mandated activity requiring NIOSH to certify respirators in accordance with 42 CFR Part 84. Under this regulation, NIOSH is responsible for directing and conducting laboratory, field, quality, and research functions related to respirator certification. Specifically, the PPT Program, through NPPTL, establishes certifica- tion testing criteria, conducts product testing, reviews the technical specifications for the product, and examines the manufacturer’s quality assurance program. The PPT Program also performs product and site audits and evaluates product TABLE 2-4  Ongoing NIOSH Extramural Grants with a PPT Component Start and End Dates Grant Title 9/2006 to 9/2011 Pacific Northwest Agricultural Safety and Health Center 9/2006 to 8/2011 Northeast Center for Agricultural Health 8/2006 to 7/2011 Active hearing protectors and audibility of critical communications 7/2005 to 7/2010 Respirator effects in impaired workers 8/2006 to 7/2009 Enclosing hood effectiveness 9/2004 to 6/2009 Centers for Construction Safety and Health 8/2006 to 7/2008 Measuring human fatigue with the BLT prototype 7/2005 to 6/2008 Assessment methods for nanoparticles in the workplace 4/2005 to 3/2008 Multipurpose protective clothing for emergency responders SOURCE: NIOSH, 2007a.

42 The Personal Protective Technology Program at N I OSH complaints as a part of the certification process. In addition, the PPT Program conducts research focused on improving testing and evaluation methods. NIOSH has been responsible for administering the respirator certification program since 1972. NIOSH and the Mine Safety and Health Administration (MSHA) jointly certify mine emergency devices. Planning and Production Inputs Budgets  Approximately 30 percent of the PPT Program’s budget from 2001 through 2007 was allocated to the respirator certification program (Table 2-2). Funding for the certification program comes from two sources: federally ap- propriated funds and certification fees charged to manufacturers submitting a certification application. Since 2001, overall funding for the respirator certification program has ranged from approximately $2.3 million to $6.4 million (Table 2-2). More than 90 percent of the funding for respirator certification is provided through federal funding (Figure 2-3; Table 2-5). The certification fee schedules for traditional respirators were set in 1972 and have not been revised since. Fees range from $750 for supplied-air respirators to $4,100 for gas masks and filtering self-rescuer respirators and from $100 to $900 for subcomponents (42 CFR Part 84). Additional fees can be levied if an examination, inspection, or testing proce- dure exceeds the normal level of effort; however, the additional fees are limited to a maximum of $100 “per man day expended.” In 2002, NIOSH was authorized to $7.00 $6.00 $5.00 $ Millions $4.00 Manufacturer Fees $3.00 Federal Funds $2.00 $1.00 $0.00 FY02 FY03 FY04 FY05 FY06 FY07 Fiscal Year FIGURE 2-3  Funding sources for respirator certification by fiscal year. SOURCE: NIOSH, 2007b. Figure 2-3.eps

R e l e va n c e of the N I OSH PPT P r o g r a m 43 TABLE 2-5  Manufacturers’ Respirator Certification Fees Retained by NIOSH Fees Retained by NIOSH FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 Non-CBRN 0 $183,800 $104,450 $120,850 $140,000 $130,150 $280,990 respirators CBRN 0 $7,000 $9,300 $53,200 $45,020 $196,842 $196,829 respiratorsa Total 0 $190,800 $113,750 $174,050 $185,020 $326,992 $477,819 aFunding of CBRN live agent testing is paid through NIOSH to the U.S. Army Research, Development, and Engineering Command. These funds are not included in the table. SOURCE: NIOSH, 2007b. retain the fees charged to manufacturers; prior to that time the fees were deposited in the general fund of the U.S. Treasury. In FY 2007, the certification program’s budget (including overhead) was ap- proximately $6.39 million (Table 2-2). Of that amount, only $477,819 (approxi- mately 8 percent) was covered by certification fees received from manufacturers (Table 2-5) (NIOSH, 2007b). To recover the actual costs of respirator certification efforts in FY 2007, NIOSH would have needed to increase its certification fees by 13 to 15 times the current amount. When the new CBRN regulations were developed (discussed below), the fee structure for CBRN certification stipulated significantly higher certification fees due to the high costs of live agent testing. Fees for CBRN respirator certification range from $175 to $21,735 (NPPTL, 2007). Although the costs for the live agent testing are covered by these higher fees, the remainder of the costs for certification testing and processing by NIOSH are not fully covered by manufacturers. The committee believes that the costs of certification testing should be borne by respirator manufacturers and that the fee structure for traditional respirators is in immediate need of revision. The fees have not been revised for more than 30 years while certification costs have increased steadily. The U.S. market for respiratory protection in 2003 was estimated at approximately $2 billion (Frost and Sullivan, 2005). An increase in fees could fully fund certification activities and allow the use of federal resources to increase research efforts to improve PPT and better protect the nation’s workers (Chapter 5). Staffing  Implementing the respirator certification process is the responsibility of NPPTL’s Technology Evaluation Branch, which in FY 2007 had 26 full-time employees. In FY 2007, management personnel consisted of a branch chief, two team leaders, and two technical analysts. Application processing requires two FTEs

44 The Personal Protective Technology Program at N I OSH to conduct an initial review, two FTEs to review quality assurance, two FTEs to function as team leaders, and analysts to conduct the final review phase. Respirator testing is conducted by eight NIOSH FTEs and four contract employees. Addition- ally, two contract employees and one NIOSH FTE provide administrative support. It should be noted that while the PPT Program has the personnel, facilities, equip- ment, and procedures to perform this work with a high degree of quality, it does not have significant redundancy in either testing personnel or facilities, so that any temporary reduction in personnel or any equipment malfunction could delay certification work. Activities The PPT Program has a robust process for carrying out its federal mandate to test, evaluate, and certify respirators. The process involves application processing, respirator testing, and quality assurance plan evaluation; product and site audits; and respirator equipment evaluation. Processing and respirator testing  Respirator manufacturers submitting applica- tions for certification must be registered with NIOSH and obtain a manufacturer’s code to allow for evaluation of the manufacturer’s quality assurance program. The NIOSH certification program currently has approximately 90 active approval holders with 100 manufacturing sites worldwide (NIOSH, 2007a). In the past five years, the certification program has processed approximately 1,900 applications (of which more than 1,400 were granted certification after testing and approximately 500 were rejected). Since 2001, over 1,600 respirator certification requests have been granted. In addition to submitting sample respirator units for testing, applications for respirator certification include results of pre-testing of the proposed design. Sample respirators undergo a series of test procedures (depending on the category of respirator) that have been developed by NIOSH and specified in fed- eral regulations. Tests conducted at the PPT Program’s facilities include detailed evaluations of the efficacy of the filters, determination of exhalation valve leakage, and evaluations of breathing resistance as well as many other specific tests. Air- purifying elastomeric facepiece respirators are tested for facepiece fit by human test subjects. The test procedures are available online for use by manufacturers prior to certification submission (NIOSH, 2008m). In addition to laboratory tests of sample respirators, the PPT Program also evaluates the manufacturer’s quality assurance program. As part of its certification efforts, the PPT Program conducts research on im- proved testing and certification methodologies. Current research efforts ­include the enhancement of existing technology to support respirator certification ­(total ­inward

R e l e va n c e of the N I OSH PPT P r o g r a m 45 leakage tests and a quality assurance module) and enhancements to standard test procedures. New standard test procedures are being developed to deal with innova- tive or novel technologies such as antimicrobial and adhesive technologies. The goal for completion of the certification process is 90 days as stipulated by Congress (Senate Report 104-368). The PPT Program has made significant efforts to meet the 90-day goal. In 2007, 81 percent of applications for air-purifying and air-supplied respirator certification were processed within 90 days compared to 75 percent in 2003 (NIOSH, 2007c; Figure 2-4). Data for the total number of air- purifying and air-supplied respirators from 2003 to 2007 show that 76 percent of applications were processed by the PPT Program in 90 days or less. Product and site audits  Audits are conducted to verify implementation and ef- ficacy of quality control plans, which are evaluated as part of the certification re- quirements. Quality assurance evaluations are conducted via product and site audits. Issuance of respirator certification requires that manufacturers maintain quality facilities, processes, and products. Each manufacturing location undergoes a site audit every two years. Mine escape respirator manufacturers undergo yearly audits. 100% Percent Processed Within 90 Days 90% 80% 70% 60% Air-Purifying Respirators 50% Air-Supplied 40% Respirators 30% 20% 10% 0% 2003 2004 2005 2006 2007 Fiscal Year Figure 2-4.eps FIGURE 2-4  Percentage of respirator certification applications processed within 90 days. SOURCE: NIOSH, 2007c.  Percentage of applications processed within 90 days is based on the PPT Program turnaround days, which refers to the total number of days the application is available for processing within the PPT Program.

46 The Personal Protective Technology Program at N I OSH Since 2001, site audits have been conducted in 16 to 43 sites annually (NIOSH, 2007b). Contractors approved and hired by the PPT Program can conduct routine initial and follow-up site audits; non-routine audits, depending on their nature, may require direct involvement of NIOSH staff members. Information provided by the PPT Program detailed the costs of facility audits as $6,000 for U.S. manufacturing facilities and $12,000 for audits conducted outside the United States. The PPT Program also conducts 40 to 60 product audits per year by selecting respirators from normal sales and distribution outlets and testing them to deter- mine product quality (NIOSH, 2007a). The PPT Program realizes that this is not a statistically significant sample and, although constrained by limited resources, is working to expand its program. One specialized type of product audit conducted by the PPT Program is the Long-Term Field Evaluation (LTFE) program, which examines the performance of mine escape respirators using a sample of respirators collected from working mines. Deployed self-contained self-rescuers (SCSRs) are compared to new SCSRs using a series of selected tests that follow the certification test standards. The most recent phase of the evaluation program found that all deployed SCSRs show some evidence of performance degradation (NIOSH, 2006). The PPT Program is working to revise the LTFE program to enhance the statistical integrity of the sampling strategy (NIOSH, 2007f). Resources are fairly limited, with approximately $570,000 devoted to this effort in FY 2007 and about half of that in FY 2006 and FY 2005 (approximately $200,000 and $240,000, respectively) (NIOSH, 2008a). The committee strongly supports expanded activities in product and field testing to provide much-needed information on the life cycle of PPT equipment and the realities of work site performance (see Chapter 5). Respirator equipment investigations  The PPT Program investigates reports of problems with all NIOSH-certified respirators through its Certified Product Investigation Process (CPIP). These investigations can be prompted by user com- plaints, product evaluations, or the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP). For product inquiries, the PPT Program’s role is to validate the report through testing and to monitor corrective actions by the manufacturer (if needed). The PPT Program also provides technical assistance to the manufacturer as needed. If a problem is not addressed, NIOSH has the author- ity to require a manufacturer to recall or retrofit a product or to revoke certifica- tion. Since 2001, product investigations (not including FFFIPP investigations) have been opened on 220 products (Table 2-6). Information about the product investigation program and the mechanism for requesting an investigation are not  The PPT Program is part of the NIOSH FFFIPP, which investigates deaths of firefighters in the line of duty with the goal of preventing future deaths and injuries (NIOSH, 2008p). The PPT Program is involved in tests of respirators and other protective equipment.

R e l e va n c e of the N I OSH PPT P r o g r a m 47 TABLE 2-6  Product Investigations, Including FFFIPP Investigationsa Product Investigations FFFIPP Opened (not including Investigations Total Fiscal Year FFFIPP) Opened Closed 2007 9 3 10 2006 26 6 37 2005 36 2 65 2004 33 4 23 2003 31 8 31 2002 46 5 39 2001 39 5 43 Total 220 33 248 NOTE: FFFIPP = Fire Fighter Fatality Investigation and Prevention Program. aThrough August 17, 2007. SOURCE: NIOSH, 2007a. readily apparent on the NIOSH website. The committee urges efforts to provide additional web-based information including a contact point, as well as other efforts to inform employers and respirator users regarding how to submit issues needing investigation. Outputs The most significant output of the respirator certification program is the num- ber of respirator certifications issued, thereby increasing the potential inventory of certified respirators available to workers. Since 2001 the PPT Program has issued more than 1,600 respirator certifications (Table 2-7). Overall, more than 8,000 res- pirator certifications have been issued since 1972. At the same time, approximately 35 percent of the applications received were denied approval or withdrawn. The PPT Program maintains the Certified Equipment List on the NIOSH website (NIOSH, 2008j). This searchable database allows employers and other respirator purchasers and users to determine if the respirator-related products they are considering have received NIOSH certification. The Certified Equipment List is also used internationally by countries that require or recommend NIOSH- certified respirators. Another PPT Program output that is used widely by the user community is the NIOSH Respirator Selection Logic (NIOSH, 2004b), which provides respirator program administrators with a process for respirator selection to protect workers in specific workplaces based on the properties of contaminants, limitations of the equipment, and assigned protection factors. Selection criteria for infectious disease

48 The Personal Protective Technology Program at N I OSH TABLE 2-7  Number of Respirator Certifications (2001-2007) by Category and Calendar Year Total Gas Supplied Chemical Particulate per Year SCBA Masks Air Particulate Cartridge Filter Year 2001 5 3 2 6 58 362 436 2002 25 3 0 4 33 181 246 2003 34 0 1 7 33 114 189 2004 22 2 9 4 16 137 190 2005 6 9 13 8 48 82 166 2006 4 4 5 12 14 99 138 2007 41 10 2 7 20 165 245 Total 137 31 32 48 222 1,140 1,610 NOTE: SCBA = self-contained breathing apparatus. SOURCE: NIOSH, 2007a, 2008p. hazards are not included in the respirator selection logic due to the lack of data. Research to correct these deficiencies is continuing. The outputs resulting from the certified product investigation process include product recalls, product retrofits, and certification rescissions. In FY 2006, 32 inves- tigations were open and a total of 37 were completed (NIOSH, 2007a). User notices are distributed through email and posted on the NIOSH website (previously notices were sent via mass mailings) to inform users of corrective actions that need to be taken to resolve performance problems with NIOSH-certified respirators. Since 2001, 32 user notices have been issued by the PPT Program, the affected respirator manufacturer, the component manufacturer, or a combination of the three. User notices are posted online through the NIOSH website, but there is no requirement that the respirator manufacturer (or distributor) maintain a formal documented listing of employers who have purchased certified equipment. As a result, there is no direct mechanism for employers who purchase respirators to learn about devices that have been recalled or require service, and workers may be put at risk because of this important gap in the process. MSHA has recently recognized this need and has implemented such a program (30 CFR 75.1714-8). In addition to user notices, the PPT Program also posts concept papers on its website. These concept papers detail certification criteria or other issues under consideration. Stakeholders are asked to provide comments, thereby increasing the transparency of the process and opening opportunities for a wider breadth of expertise to be brought to bear on the issue. Current concept papers include one on powered air-purifying respirator performance criteria (NIOSH, 2008n).

R e l e va n c e of the N I OSH PPT P r o g r a m 49 Committee Comments on Relevance to Occupational Safety and Health The PPT Program’s extensive work on respirator certification is highly relevant to occupational safety and health because it provides workers with respirators that have been rigorously tested to meet performance criteria for protection against haz- ardous respiratory exposures. NIOSH certification is well respected as a thorough assessment of the capabilities of respirator equipment and is the accepted standard in the United States as well as in other countries. The PPT Program continues to work to meet the goal of a 90-day certification process. The major opportunities to improve the certification process focus on expedit- ing updates to the certification regulations (discussed below), including revisions of outdated certification fee schedules. The committee urges accelerated efforts to significantly revise the fee structure while working to ensure that the current level of funding is retained by the PPT Program and used to expand much-needed research and standards activities (see Chapter 5). Strengthening the product and site audit program is also key. Federal Regulations and Consensus Standards Setting Improving respirators, and thereby reducing exposures to respiratory hazards, is in large part an effort focused on updating, refining, and developing the tests and performance criteria that respirators must meet to provide effective protec- tion in the workplace. These effectiveness criteria are implemented through federal regulations and consensus standards. Federal regulations for respirator certification are detailed in 42 CFR Part 84 and aim to assess the efficacy of respirators used in U.S. workplaces as mandated by Occupational Safety and Health Administration (OSHA) workplace regulations. Efforts to change the regulations involve a complex and lengthy federal rule-making process (described below). In addition to federal regulations, criteria for respirator performance are implemented through consen- sus standards organizations such as the International Organization for Standardiza- tion (ISO) and the National Fire Protection Association (NFPA). Planning and Production Inputs The PPT Program’s efforts in standards and regulations (as applied in this report to the 12 objectives) are focused in NPPTL’s Policy and Standard Develop- ment Branch. These efforts are informed by ongoing work throughout all aspects of the PPT Program. The budget for policy and standards development activities in the PPT Pro- gram was $1.84 million in FY 2007, the lowest annual total for the years exam- ined by the committee (Table 2-8). Increased funding totals in FY 2002 through

50 The Personal Protective Technology Program at N I OSH TABLE 2-8  Funding for NIOSH PPT Policy and Standards Development FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 Funds expended (million dollars) 2.25 4.34 7.59 4.35 6.69 3.78 1.84 SOURCE: NIOSH, 2007a. FY 2005 reflect additional resources for the development of CBRN regulations made available through the Department of Homeland Security. The PPT Program obtains input from manufacturers, employers, employees, and other stakeholders through several venues. This input is used not only in revis- ing federal regulations and consensus standards but also in planning for research priorities, considering changes in certification, and strategic planning. Thus, the following overview of the public input to the PPT Program applies to all PPT Program efforts. The PPT Program has been active in organizing public meetings (Box 2-1). The work on establishing CBRN respirator standards involved one to two public meetings annually for several years in addition to widespread input from profes- sional organizations and federal agencies. In the early phases of its initiative on total inward leakage (TIL), the PPT Program held a public meeting in July 2004 to gain stakeholder feedback on the concept and testing plan. In addition, input was requested through a Federal Register notice. Similarly in June 2007, after complet- ing testing on half-facepiece respirators, the PPT Program held a public meeting to receive further feedback on the TIL efforts. In November 2004, the PPT Program organized the workshop Respiratory Protection for Infectious Agents to explore research gaps. The PPT Program’s listserv is used to disseminate information to more than 2,500 subscribers. Peer review panels are another mechanism for receiving input to the PPT Pro- gram. In addition to the Institute of Medicine panels described throughout this chapter, the PPT Program has convened peer review teams to assess various parts of its research program. For example, in 2004, a peer review team evaluated the total inward leakage research protocol (NIOSH, 2007a). The PPT Program’s work on end-of-service-life (ESLI) indicators for respirator cartridges also benefited from assessment through a formal peer review held in the spring of 2005. Recently, the PPT Program has begun to solicit the input of the user com- munity through customer surveys. The first survey of manufacturers and users was conducted in 2005. Survey results are posted on the NIOSH website (NIOSH, 2007g). The next survey was in the process of being conducted during the course of this study.

R e l e va n c e of the N I OSH PPT P r o g r a m 51 BOX 2-1 NIOSH-Sponsored PPT Meetings Public Meetings Date Major Topic March 6, 2008 PPT Program March 22, 2007 LTFE Program Concept October 12-13, 2006 New program ideas including total inward leakage September 28, 2006 Closed-circuit escape respirators September 19, 2006 Closed-circuit escape respirators April 27, 2006 Expediting the respirator certification process December 13, 2005 CBRN respirator standards July 19-20, 2005 CBRN respirator standards December 15, 2004 CBRN respirator standards August 24, 2004 Total inward leakage requirements May 4, 2004 CBRN respirator standards October 16, 2003 CBRN respirator standards June 25, 2003 CBRN respirator standards April 29, 2003 CBRN respirator standards April 10, 2003 Standards for respiratory devices June 18-19, 2002 CBRN respirator standards April 4-5, 2001 Research directions for NPPTL Manufacturer Meetings April 10-12, 2007; October 11, 2006; July 21, 2005; April 13, 2005 NOTE: CBRN = chemical, biological, radiological, and nuclear; LTFE = Long-Term Field Evalu- ation; NPPTL = National Personal Protective Technology Laboratory. Activities and Outputs The PPT Program’s efforts in policy making and standards setting occur through two major avenues: the federal rule-making process and consensus stan- dards organizations. Federal regulations  Since the certification program is conducted under the auspices of 42 CFR Part 84, it operates with the force of law under the authority of the federal regulatory enforcement statutes and is supported by the federal rule- making process. The federal rule-making process, as outlined in the Administrative Procedure Act (5 USC 5 [511-599]) ensures that the rule is carefully constructed,

52 The Personal Protective Technology Program at N I OSH that the public has full knowledge of the force of the rule, and that there is ample opportunity for those who will be affected by the rule to comment on it in a manner that ensures that the agency will take those comments into account. All of this takes time. Rough estimates are that this is at least a 2- to 3-year process from develop- ment of the performance criteria and background documents to enactment of the final rule. The steps in the rule-making process are summarized in Table 2-9. The PPT Program through NPPTL has developed a modular approach to updating federal regulations. Instead of updating the entire set of respirator certi- fication regulations, the PPT Program is updating sections of the regulations. The overview of the PPT Program’s activities and outputs in this area begins with a description of the CBRN standards and then focuses on other regulations that are in the process of being updated. CBRN respirator certification standards  The many-faceted efforts to develop and implement standards for the certification of CBRN respirators have been a TABLE 2-9  Steps in the Federal Rule-Making Process for Changes to 42 CFR 84 Estimated Time to Completion Step (months) 1. Preparation of the proposed rule 12-24 (these activities take place • Develop conceptual requirements before the involvement of higher • Finalize technical criteria and standard test procedures agencies and the OMB) • Finalize the preamble 2. Conduct higher agency reviews by NIOSH, CDC, and 6a DHHS 3. OMB reviews proposed rule 3 4. Submit proposed rule for publication in Federal Register; 3 open comment period; receive comments regarding the proposed rule in a docket 5. Address comments received in the docket; conduct 3 information exchange public meetings if necessary 6. Prepare final rule and conduct higher agency review 6 7. OMB review of final rule 3 8. Publish final rule in Federal Register NOTE: CDC = Centers for Disease Control and Prevention; DHHS = Department of Health and Human Services; OMB = Office of Management and Budget. aEstimated based on 60 days with each agency. SOURCE: NIOSH, 2008i.

R e l e va n c e of the N I OSH PPT P r o g r a m 53 major focus of the PPT Program since the inception of NPPTL in 2001. After the terrorist attacks on the United States in 2001, efforts were expedited to certify res- pirators that could provide protection against CBRN threats. As described through- out this report, the CBRN effort involved extensive collaborations with numerous partners and many public meetings. PPT Program staff worked with partner organizations and contractors to collect and evaluate more than 340 standards for respiratory protection equipment from 32 countries and standards organizations (NIOSH, 2007a). Relevant and applicable standards that met the performance requirements were adopted. Further, the toxic industrial chemicals and toxic indus- trial materials requirements were researched and developed by the PPT Program. A number of public meetings were held to focus on CBRN regulations and obtain stakeholder input. As a part of the efforts to establish CBRN standards for respira- tors, the PPT Program fast-tracked the development of an exploratory benchmark test to assess the performance of commercially available self-contained breathing apparatus (SCBA) respirators against chemical warfare agents. Existing U.S. Army chemical warfare agent test methods were adapted, and benchmark testing was ini- tially conducted on SCBA respirators that were available to emergency ­responders in the United States. Testing of CBRN respirators using live agents is conducted by the U.S. Army under an interagency agreement between NIOSH and the U.S. Army Research, Development, and Engineering Command. Separate CBRN regulatory standards are needed for each of the relevant classes of respirators; part of that process is still under way. The initial regula- tion, completed in January 2002, was for the certification of SCBA respirators for CBRN exposures; updates to the SCBA regulations were completed in March 2003 (NIOSH, 2008k). Subsequently, the regulations were completed for CBRN gas masks (March 2003), CBRN escape sets (October 2003), and powered air- purifying respirators (PAPRs) (October 2006). The remaining CBRN respirator regulatory standards (for supplied-air respirators, closed-circuit SCBAs, and combination sets) will be completed through the standard (not expedited) rule- making process. The primary output of these efforts has been the certification of CBRN res- pirators. From FY 2002 through FY 2007, 45 respirators received CBRN certifica- tion and there were 20 certified retrofits (NIOSH, 2008o). The PPT Program has produced a number of guidance documents and fact sheets that are highly relevant to the use of CBRN respirators (e.g., NIOSH, 2004c, 2005c), and PPT Program staff have disseminated information on the CBRN standards through professional conferences (e.g., Boord and Dower, 2002). Additionally, as a result of contracts with Pennsylvania State University and RAND, reports on PPT guidelines for emergency responders were published and distributed (LaTourrette et al., 2003; Ramani et al., 2003).

54 The Personal Protective Technology Program at N I OSH The PPT Program responded quickly to the challenges of developing and implementing CBRN certification regulations—an effort that involved coordinat- ing with multiple agencies and organizations and was accomplished through a well-organized and open process. Respirator regulatory changes  At the time this report was being prepared, five other modules of the respirator regulations were in various stages of development (Table 2-10). The PPT Program is in the process of developing a draft standard for powered air-purifying respirators that would allow application-specific requirements for PAPRs designed for specific uses, such as hospitals. These respirators are effective against airborne contaminants in an industrial setting, but their high flow rates are impediments to their use in other occupations, such as health care, where the noise level needs to be reduced. The concept paper for the PAPR standard was published on the NIOSH website in January 2008 (NIOSH, 2008n), and the plan is for sub- mission for review in December 2008. Public meetings regarding the updated mine escape respirator (closed-circuit escape SCBA) were held in 2003, the concept paper was published in 2004, and the regulatory revision was submitted for review in July 2007. Regulatory revisions regarding closed-circuit self-breathing apparatus respira- tors and supplied-air respirators are in development and anticipated to be submitted for review by December 2009. Another of the anticipated regulatory changes focuses on total inward leakage. This regulation will provide improved procedures in the cer- tification process for examining the fit of respirators. Air-purifying respirators have not been required to be evaluated for fit since the revision of 42 CFR Part 84 in 1995. The concept paper regarding total inward leakage was published in 2004 (NIOSH, 2008q), and current plans are to submit it for review in the summer of 2008. One of the significant sections needing expedited revision is the certifica- tion fee schedule. As discussed in the earlier section on the budget for respirator TABLE 2-10  Status of Federal Regulatory Changes (as of March 2008) Closed-circuit escape respirator Submitted for higher agency review in July 2007 Quality assurance module Submitted for higher agency review in October 2007 Total inward leakage (half-masks and full In development; to be submitted for higher agency facepiece respirators) review in July-August 2008 Powered air-purifying respirators In development; to be submitted for higher agency review in December 2008 Closed-circuit self-contained breathing In development; to be submitted for higher agency apparatus and supplied-air respirators review by December 2009 SOURCE: NIOSH, 2008i.

R e l e va n c e of the N I OSH PPT P r o g r a m 55 certification, only a fraction of the costs of respirator certification are borne by the certification fees paid by manufacturers. Because the CBRN regulations have recently been revised, they include the cost of the specialized testing that is done for those respirators, although total costs are still not fully recovered by the PPT Program. Further, product and facility auditing costs are paid with federal funds and should be included as part of the certification fee. The PPT Program has a goal of completing two regulatory modules per year. This is a reasonable goal and one that the committee believes the PPT Program should be able to meet. The committee sees these revisions and additions to the regulatory standards as a major opportunity for the PPT Program to improve respirator performance through updated tests that address current and evolving technologies (see further discussion below and in Chapter 5). Consensus standards  The PPT Program staff is actively involved in work on developing consensus standards relevant to respirators. Regarding CBRN issues, PPT Program staff work on the relevant NFPA technical committees and assisted in the 2007 revision of NFPA 1981, the NFPA Standard on Open-Circuit SCBA for Emergency Services. Work is also ongoing with the ISO Human Factors Committee regarding standards for CBRN respirators. PPT Program staff members participate on the ASTM committee focused on nanotechnology issues for PPT, as well as on the ISO technical committee that is working on developing standards and guidance documents (NIOSH, 2007a). Simi- larly, PPT Program staff members are active in efforts to incorporate the results of anthropometric research into ISO consensus standards. The PPT Program is also involved in ongoing efforts with the ASTM technical committee working to develop test methods for biological decontamination procedures for PPT as well as ANSI (American National Standards Institute) Z88 standards for respiratory protection. Committee Comments on Relevance to Occupational Safety and Health Federal rule-making and consensus standards are highly relevant to improving the criteria by which respirators are evaluated. Both of these mechanisms offer the opportunity to apply research results directly to product improvement. The federal regulatory work on CBRN standards has been, in many ways, a breakthrough ef- fort by the PPT Program. It has shown the value of a collaborative approach with multiple partnerships, the use of applicable industrial and military technologies, and the value of innovation in expediting the development and publication of new testing and respirator certification standards. The process was open and transparent with significant input from stakeholders. The PPT Program has also been active in a number of highly relevant efforts to improve consensus standards for respirators.

56 The Personal Protective Technology Program at N I OSH The expedited nature of the changes in CBRN regulations, however, stands in contrast to the lengthy processes for other changes in respirator certification regulations. Most regulations have not been changed significantly in more than 35 years (Federal Register, 1972). For some other regulations the changes have been discussed and in process for five years or more. In 1995, regulations on particulate filters were completed as part of the changes from MSHA regulations (30 CFR Part 11) to public health regulations under the responsibility of NIOSH (42 CFR Part 84). The significant backlog in rule making is delaying the use of new technolo- gies and tools for respirator certification. The PPT Program’s recent move toward a modular approach to rule making is a step in the right direction. Updates to the respirator certification process are constrained by the require- ments of federal rule making, which is a time-intensive process. Although a number of external factors play a significant role in the speed of the rule-making process, the committee believes that with increased resources and focused attention, the pro- posed changes and additions to the regulations could be moved more expeditiously through the rule-making pipeline (see Chapter 5). Many important improvements to respirators are currently being explored by the PPT Program and require the supporting regulatory framework. An important part of that effort will be accelerating changes to the regulations that set the certification fee structure. As noted above, federal funding is being used to cover more than 90 percent of the costs of the certification process. Because of the robustness of the respirator market, the committee believes that certification costs should be covered by respirator manufacturers, just as PPT manufacturers cover third-party certification costs for other types of PPT. The certification cost is a one-time cost for each type of respirator submitted for testing. After receiving certification, the manufacturer can produce hundreds to millions of that type of product and therefore the certification costs are spread out over many items. The revised fee structure should include all costs of certification, including costs in- curred in post-certification auditing. Further, the fee structure needs to incorporate the capacity for an annual adjustment tied to the rising costs of certification based on an audit of certification costs. It is critically important that the federal funds now used to cover certification costs be directed to fund much-needed research for all types of PPT (e.g., protective clothing, respirators, eye protection) across all relevant occupational sectors. Research NIOSH has a considerable research portfolio focused on addressing hazardous exposures and respiratory disease. The NIOSH Respiratory Disease Research Program, the topic of another National Academies’ review (NRC and IOM, 2008b), addresses the

R e l e va n c e of the N I OSH PPT P r o g r a m 57 reduction of respiratory disease through the broad hierarchy of occupational health controls (as described in Chapter 1). The focus of the PPT Program’s research and of this review is on one aspect of the controls—the personal protective technologies. The PPT Program’s evidence package (NIOSH, 2007a) outlined the following five objectives related to research on reducing exposure to inhalation hazards. Some of these objectives also include components related to the certification process or to federal regulatory or consensus standards. 1. ���������������������������������������������������������������������������� Ensure the availability of mine emergency respirators for escape from mines. 2. ������������������������������������������������������������������������������ Improve reliability and level of protection by developing criteria that influ- ence personal protective equipment designs to better fit the range of facial dimensions of respirator users in the U.S. workforce. 3. ����������������������������������������������������������������������� Quantify the impacts of various personal protective equipment on viral transmission. 4. ��������������������������������������������������������������������� Evaluate nanofiber-based fabrics and NIOSH-certified respirators for r ­ espiratory protection against nanoparticles. 5. ��������������������������������������������������������������������������� Develop and make available end-of-service-life indicator technologies that reliably sense or model performance to ensure respirator users receive e ­ ffective respiratory protection. Planning and Production Inputs Most of the research conducted through the PPT Program is focused on respiratory-related PPT. In FY 2007, spending for research on protection against respiratory hazards totaled $3.7 million (not including overhead), about 77 percent of the total research budget for the PPT Program or about 28 percent of the PPT Program’s total budget (NIOSH, 2007a). As noted above, the PPT Program has held many public meetings, manufacturers’ meetings, and conferences to obtain input on its research efforts. This deliberate process of planning and consultation has extended to the development of new capacities for conducting laboratory research. For example, peer reviews and public meetings preceded the decision to establish a fit test and TIL test facility to conduct benchmark testing for respirators. The laboratory has been equipped with aerosol measurement instruments, as well as with equipment that allows PPT Program researchers to examine the impact of respirators on communications and speech transmission. Activities and Outputs The PPT Program has conducted a broad array of research efforts that are sum- marized only briefly in the text below. As with other parts of this report, the analysis

58 The Personal Protective Technology Program at N I OSH is focused on NIOSH’s PPT efforts related to protection against inhalation and dermal hazards. Research and other efforts on additional types of PPT (e.g., hearing protection, fall harnesses) are also underway at NIOSH and, as discussed in Chapter 5, should be part of an expanded effort to integrate all PPT work at NIOSH. Mine escape respirators  More than 32,000 coal miners who work underground are required to have access to an employer-supplied self-contained self-rescuer respirator that can be used to escape from a mine fire or other situation resulting in a hazardous atmosphere (NIOSH, 2007a). New requirements from the federal Mine Improvement and New Emergency Response Act of 2006 (MINER Act) include expanded training and improved access to these respirators. The PPT Program works with MSHA on investigations of issues related to SCSRs and participates in investigations of respira- tors recovered from mine disasters. The PPT Program has identified improvements in mine escape respirators as a priority area and, as mentioned above, has sought public input on design issues. The research portion of the PPT Program’s work on mine escape respirators is focused on the development of the next generation of self- contained self-rescuers. Resources for this effort have been limited ($200,000 in FY 2004, $84,483 in FY 2005, and $614,482 in FY 2007; NIOSH, 2008a). Workshops sponsored by the PPT Program and the National Technology Transfer Center discussed the requirements for the next generation of mine escape respirators and identified a need for dockable and hybrid equipment that combines a lightweight, easy-to-use, self-contained filtering unit with the ability to connect the respirator to additional units of breathable air (without having to remove the respirator). Efforts to develop the performance requirements and certification standards for these new types of respirators are continuing. In 2007, the PPT Program contracted with a p ­ rivate-sector company to design and produce an escape respirator with dockable and hybrid features. A prototype has been developed and is in the testing phase. The PPT Program began a new research project in FY 2008 that is examining the physi- ologic burden of mine escape devices, but the funding is quite limited. The PPT Program has also conducted research on training methods and on technologies that may aid in mine escape and has worked with MSHA to develop training modules that were distributed to 1,850 mines in 2006 (NIOSH, 2007a). Surveillance efforts through the long-term field evaluation of SCSRs are an im- portant part of the effort to improve mine safety, and as noted in Chapter 5, the committee urges increased field testing efforts in mines and in other types of work sites that use PPT. Fit and anthropometrics  Research on improving the effectiveness of respira- tors has focused on the two main areas of concern—the fit and the filter. NIOSH

R e l e va n c e of the N I OSH PPT P r o g r a m 59 has a long history of research and working with manufacturers and others to improve both the filtration and the fit of a range of respirator types (for ex- ample, Coffey et al., 1998a,b). In 2003, the PPT Program began research on the total inward leakage of respirators with the goal of further improving the fit of respirators by quantifying the extent of leakage particularly around the face seal of the respirator. Research by the PPT Program has focused on developing TIL performance characteristics and laboratory tests (NIOSH, 2004a). Extensive test- ing and research are going into this effort. For example, in 2006, a panel of test subjects participated in tests of 101 models of half-facepiece respirators to assist in refining performance criteria; the results of this study should be published. The proposed criteria for use in the respirator certification process were the topic of a June 2007 public meeting. The PPT Program has recently begun work on studies assessing changes in respirator fit and the effect of weight change on respirator fit. Another related area of PPT research aims to improve respirator fit by identify- ing a panel of facial anthropometric characteristics that are representative of the U.S. worker population. Individuals with characteristics that fit the parameters in the panel are recruited to test respirators. The panel characteristics are also used to develop manikin-type head forms for testing. The PPT Program’s most recent focus in this area has been on updating the test panel that was developed in the 1970s. The PPT Program developed and implemented (through the work of a contractor) the measurement of approximately 4,000 individuals using traditional measurement tools and/or a three-dimensional scanning system (for a subset of the group) to characterize face and head shapes (Anthrotech, 2004). The results were analyzed by PPT Program researchers and used to develop suggested panels for evaluating half- and full-face respirator fit testing. Publications and presenta- tions on the anthropometric research include work by Zhuang and Bradtmiller (2005) and Zhuang and colleagues (2004, 2005, 2006, 2007). The PPT Program contracted with the Institute of Medicine to examine the anthropometric survey and related research issues, and the resulting Institute of Medicine report (IOM, 2007) provided a number of recommendations for improvements. As a follow-up, the PPT Program developed a detailed response in moving forward in these areas of research (NIOSH, 2008f). Software developed for the principal component analysis of the anthropomet- ric data is being tested by NIOSH and other partners. The panel developed through the anthropometric research is also being used in work on the total-inward leakage certification requirements, and the head circumference and neck circumference data have been used as part of the new CBRN standard for escape respirators and hoods (NIOSH, 2007a).

60 The Personal Protective Technology Program at N I OSH New areas of research—pandemic influenza and nanotechnology  Recent ad- ditions to the intramural research portfolio focus on preparation for pandemic influenza and on nanotechnology. The growing recognition of the vulnerability of the United States and other countries to the potential for an influenza pandemic and the 2003-2004 outbreaks of severe acute respiratory syndrome (SARS) have focused attention on the avail- ability and use of PPT in the event of a pandemic, particularly for healthcare workers involved in the front line of defense against infectious disease. The PPT Program’s research on pandemic influenza began in FY 2006. PPT Program re- searchers are conducting projects focused on the efficacy of decontamination methods for filtering facepiece respirators, the duration of the viability of the influenza virus on PPT, and the effectiveness of respirators or respirator-surgical mask combinations (NIOSH, 2007a). Other research efforts are focused on exam- ining biocidal technologies and their use in respirators. Research being conducted in collaboration with West Virginia University is focused on understanding the production of aerosols by human coughs. The focus of recent research has been guided in part by the issues identified by two IOM reports (IOM, 2006, 2008). The PPT Program contracted with the IOM for a study specifically on the PPT needs of healthcare workers in the event of pandemic influenza (IOM, 2008). Recently the PPT Program released its response to the report and its action plan for following up on the report’s recommendations (NIOSH, 2008g). The resources devoted by the PPT Program to pandemic influenza research have declined from an initial budget of nearly $1.5 million in FY 2006 to approxi- mately $780,000 in FY 2007 and $480,000 in FY 2008 (Table 2-2). Despite the im- portance of the research on PPT for pandemic influenza hazards and its relevance to protecting workers, there is concern that the priority may be shifting away from this issue even though much important work remains undone. Although there is evidence that the PPT Program has leveraged its minimal resources effectively in this area by sponsoring conferences and reports that have served to identify criti- cal issues, the resources for a comprehensive research program to deal with those issues are lacking. The PPT Program’s outputs regarding pandemic influenza preparedness in- clude interagency efforts and workshops (see above), in addition to publications (Roberge, 2008a,b) and presentations (e.g., Gardner et al., 2006). The 2004 work- shop Respiratory Protection for Infectious Agents was organized by the PPT Program to identify research gaps. Information from this workshop has been incorporated into NIOSH research proposals (NIOSH, 2007a). The PPT Program began its work in nanotechnology in FY 2005 by examining the efficiency of NIOSH-approved respirator filter materials in protecting against aerosol particles of 20 to 100 nm. The PPT Program has also funded research in

R e l e va n c e of the N I OSH PPT P r o g r a m 61 a collaborative effort with the Center for Filtration Research at the University of Minnesota to examine the filtration of nanoparticles between 3 and 20 nm (Kim et al., 2007). The PPT Program is part of the efforts of the NIOSH-wide Nanotech- nology Research Center, and PPT Program staff members have participated with other NIOSH colleagues in developing the NIOSH strategic plan on nanotechnol- ogy (NIOSH, 2005a). The PPT Program is also involved in research on the use of nanotechnology as applied to PPT. In particular, PPT Program staff conducted a set of studies on the use of respirator filter media that incorporated nanofiber materials. The studies were appropriately terminated due to challenges in develop- ing adequate samples. The investment in nanotechnology-related research has averaged approxi- mately $315,000 annually from FY 2006 to FY 2008 (Table 2-2), and the committee believes that the PPT Program has made appropriately focused decisions given its limited resources. The more important issue of respirator face seal leakage is in the early phases of research. Leakage is an important question since it is known that leakage around the face seal is the weakest part of a negative-pressure respira- tor, and nanoparticles are more likely to penetrate leaks than are larger particles. Manikin-based tests are likely to raise more questions than answers. Therefore, fieldwork will likely be necessary to determine the impact of ultrafine particles on leakage and exposure and the impact of this program on worker health. The PPT Program evidence package also indicated that research is being considered regarding the role of nanotechnology-based sensors, which may hold promise for future PPT efforts. Although, its work on nanotechnology is in its early phases, contributions have been made by the PPT Program including input into the NIOSH strategic plan on nanotechnology (NIOSH, 2005a) and a focused look by NIOSH at nanotechnology issues in the workplace, Approaches to Safe Nanotechnology (NIOSH, 2007d). PPT Program staff members have made a number of conference presentations in this area, and the PPT Program has been involved in peer-reviewed publications on respirators and nanoparticles (Kim et al., 2007; Rengasamy et al., 2007). End-of-service-life indicators  An ongoing issue in respirator use has been iden- tifying accurate methods of determining the end of the service life of the ­carbon- based materials used in air-purifying respirators. OSHA regulations (29 CFR 1910.134) mandate that employers use a formal change schedule or an end-of- service-life indicator. The PPT Program’s research in this area began with a focus on the development of software models to provide users with a method for predicting the cartridge service life. The Breakthrough software was released in 2004 (NIOSH, 2005b). The newer MultiVapor software, designed to assess breakthrough times and service lives for air-purifying respirator cartridges for multiple organic vapors,

62 The Personal Protective Technology Program at N I OSH was released in May 2007 (NIOSH, 2007e). Both are available on CD-ROM; the MultiVapor software is also available on the OSHA website with more than 4,500 downloads (NIOSH, 2007a,e); several published peer-reviewed journal articles have provided more detailed information (Wood, 2004, 2005). Recent work by the PPT Program, in collaboration with Carnegie Mellon University, several manufactur- ers, and others, focuses on sensor systems to detect gases and vapors and provide a signal indicating breakthrough (see Chapter 3). The second phase of the ESLI research program focuses on the development of a sensor that can be embedded in the cartridge and detect vapor breakthrough (King et al., 2007; see further details below and in Chapter 3). Committee Comments on Relevance to Occupational Safety and Health The PPT Program’s research relevant to respiratory exposures encompasses a wide range of efforts to improve respirators and respirator-related technolo- gies. The PPT Program has moved the research agenda forward in many impor- tant directions and has become involved in a number of cutting-edge issues and technologies. The PPT Program has sponsored timely conferences and developed relevant research initiatives regarding respiratory protection in an influenza pan- demic. However, many research questions remain, and additional resources would allow the PPT Program to develop wide-ranging partnerships with industry and academia to address additional high-priority areas of research. The committee believes that NIOSH has made important strides in forwarding the knowledge base on facial anthropometrics and on respirator fit and total inward leakage. The significance of a user seal check to determine or confirm individual respirator fit requires additional investigation by the PPT Program. At the same time, the committee urges a strong and sustained focus on exploring materials sci- ences and other technologies that may obviate the need for fit testing and improve the individualized fit of PPT. Given the challenges in the workplace of fit testing workers and ensuring that they have proper equipment, the greatest need is for simplifying or eliminating the fitting process. The PPT Program is sponsoring an upcoming workshop to explore new technologies that could provide “fits-all” or “universal-fit” respirators that could easily and effectively conform to fit all face types; further efforts on this topic are needed. The PPT Program has provided extensive outreach opportunities for input from the general public, manufacturers, employers, and state and federal agencies. The PPT Program is also engaged in a number of partnerships that are effective in leveraging available resources. More should be done to further training efforts on PPT use and to provide data to employers and employees on the effectiveness of PPT in the workplace.

R e l e va n c e of the N I OSH PPT P r o g r a m 63 GOALS 2 AND 3: REDUCE EXPOSURES TO DERMAL AND INJURY HAZARDS In addition to respiratory hazards, many U.S. workers face daily exposures to hazardous chemicals or other toxicants that could potentially be absorbed through the skin; other workers deal with the potential for injury from heat, falls, noise, heavy or sharp objects, and a range of other hazards. NIOSH is currently working through several of its divisions to address relevant PPT aimed at mitigating these occupational hazards. NIOSH’s efforts that are reviewed in this report focus on the 12 objectives the committee was asked to examine, of which 4 objectives are related to dermal and injury hazards. The PPT Program’s work on reducing exposures to dermal and injury hazards is accomplished through research and participation in standards-setting efforts. The PPT Program does not have certification responsibilities for protective cloth- ing, gloves, or any other type of dermal or injury PPT. Some of those products are certified by third-party organizations (e.g., Safety Equipment Institute, Underwrit- ers Laboratory) or are manufactured to meet specific consensus standards. The relevant dermal and injury objectives for this review as identified by the PPT Program follow: • Improve chemical-barrier protective clothing testing and use practices to reduce worker exposure to chemical dermal hazards. • Improve emergency responder protective clothing to reduce exposure to thermal, biological, and chemical dermal hazards. • Investigate physiological and ergonomic impact of protective ensem- bles on individual wearers in affecting worker exposure to dermal hazards. • Develop and evaluate warning devices for fire services. In contrast to exposures to hazards via the respiratory route, which usually have well-characterized guidelines and standards for safe occupational exposure levels, dermal hazards and safe occupational exposure levels are poorly defined. Thus, the primary challenges for dermal PPT are to understand the level of protec- tion needed for different sectors (i.e., industrial, pharmaceutical, healthcare, and agricultural workers) and then utilize the tactical approaches identified above to systematically address the health and safety of workers in these various sectors. In addition to evaluating the protection offered by protective clothing and gloves, a wearer’s ability to carry out his or her job efficiently and effectively while wearing the PPT must be addressed. Thus, issues regarding dermal PPT include dermal hazard assessment, permeation of hazards through the skin and through protective

64 The Personal Protective Technology Program at N I OSH clothing or other PPT, physiological and ergonomic impact of the PPT, durability, and decontamination and reuse. Planning and Production Inputs Only a small percentage (10 percent in FY 2007) of the PPT Program’s total budget is allocated for dermal and injury-related efforts (Table 2-2). In large part this is due to NIOSH’s historical focus and congressional mandate on respirator certification and on improving the quality and effectiveness of respirators. In FY 2007, $1,142,320 was designated in the PPT Program’s budget for work on reducing hazardous dermal exposures and $176,453 for work on the one objective related to reducing exposure to injury hazards (data include overhead costs; Table 2-2). Other efforts at NIOSH are focused on PPT for injury prevention but are not included in these budget figures. Similarly, only a small number of staff members are involved in work on reducing dermal exposures. In FY 2008, out of a total of slightly more than 70 total FTEs in the PPT Program, 4.6 worked on projects related to dermal exposures, and the staff allocation for work on the sensor system for reduction of injury hazards was 0.6 FTE (Table 2-3). The laboratory facilities for the PPT Program’s intramural dermal research program have expanded in recent years with the addition of the aerosol laboratory and human research physiology laboratory in 2005. The committee regards this as a step in the right direction. The committee compiled a rough timeline specific to the PPT Program’s inputs, activities, and outputs related to dermal exposures (Box 2-2). Of note in the planning inputs is the 1998 NORA (National Occupational Research Agenda) conference Setting the Research Agenda for Control of Workplace Hazards for the 21st Century, which identified some of NIOSH’s research priorities in this area. The PPT Program has heightened the relevance of its work in dermal and in- jury PPT by seeking input from workers, manufacturers, professional associations, employers, and many others through a variety of different venues. At a Centers for Disease Control and Prevention (CDC) stakeholders meeting in April 2001, 16 emergency responders met and developed a 5-year concept research plan relevant to protective clothing (CDC, 2001). As part of its response to the terrorist events of September 2001, the PPT Program organized a conference in December 2001 to hear from emergency responders, firefighters, and others on what needed to be done to improve PPT for responding to such events. As noted above in the dis- cussion on respirator-related standards, the PPT Program holds frequent public meetings and provides multiple avenues for stakeholder input. Most of the public meetings have focused on respirator-related issues, but recent meetings, particu- larly the March 2008 public meeting, have had a broader focus that included mul- tiple types of PPT.

R e l e va n c e of the N I OSH PPT P r o g r a m 65 BOX 2-2 Timeline of Key Events for the Dermal PPT Program— Inputs, Activities, and Outputs 1998 • NORA workshop, Setting the Research Agenda 2001 • CDC-sponsored emergency responder stakeholder meeting • Research studies initiated on decontamination methods • Conference focusing on PPT for emergency workers 2003 • Protective clothing lab established at NPPTL 2004 • MOU established between NIOSH and TSWG to evaluate next-generation structural firefighting PPT with chemical or biological protection 2005 • Intramural research begun on Project HEROES® • MOUs established between NIOSH and ASTM and between NIOSH and NFPA • Decontamination work used to develop AIHA guideline • Aerosol laboratory and physiology laboratory established • Conference on protecting first responders • EMS protective clothing project begun 2007 • Permeation calculator released • MOU established between TSWG and NIOSH to collaborate on permeation criteria initiatives NOTE: AIHA = American Industrial Hygiene Association; EMS = Emergency Medical Services; HEROES = Homeland Emergency Response Operational and Equipment Systems; MOU = memorandum of understanding; TSWG = Technical Support Working Group. Activities and Outputs Intramural research on dermal protection began in NIOSH before the PPT Program was established; several of the projects were transferred in 2001 when NPPTL was created. Other projects, particularly on dermal hazard assessment, remain in the NIOSH divisions working in those areas.

66 The Personal Protective Technology Program at N I OSH A series of intramural NIOSH studies in the late 1990s and early 2000s (trans- ferred to NPPTL after 2001) focused on the development of colorimetric or sorbent indicators for assessing chemical permeation through gloves. NIOSH researchers worked on indicators that could be incorporated into the inside of gloves so that they would change color when exposed to specific hazardous chemicals (i.e., after permeation through the glove). After a number of NIOSH studies and publications (e.g., Vo, 2004), further work in this area was deemed to be most appropriate for the private sector. Permeation and Decontamination Decontamination of chemical protective clothing was identified as a priority research area in the 1998 workshop Control of Workplace Hazards (NIOSH, 2007a), with goals of developing suitable methods and procedures for effectively decon- taminating and extending the useful life of chemical protective clothing. The PPT Program’s research has involved intramural tests on the degradation of materials in chemical protective clothing as a result of decontamination processes and the effectiveness of a variety of decontamination approaches. The PPT Program has contracted with a private-sector lab to conduct permeation testing and also has had a contract with the University of California, Davis, to explore the concept of developing self-decontaminating functional textiles and polymers for protective clothing. This research has contributed to the knowledge base on decontamination and reuse. However, much remains to be learned on efficient and effective decon- tamination methods. PPT Program staff members have been active in working with the American Industrial Hygiene Association (AIHA) in the development of the AIHA guideline on the decontamination of chemical protective clothing and equipment (see Chapter 3). The PPT Program’s research on dermal protection has resulted in the devel- opment of a permeation calculator that utilizes the results of chemical protective clothing permeation experiments (e.g., using ASTM test methods) to derive pa- rameters such as steady-state permeation rate and breakthrough detection time (Gao et al., 2005; NIOSH, 2008b). The permeation calculator is available on the NIOSH website or on CD. More recently, the PPT Program is exploring decontamination issues relevant to protective clothing used by emergency responders to better understand how the wear-and-tear that these products undergo on a daily basis impacts cleaning and decontamination. Work on this project is being done in concert with a private- s ­ ector firm and through interactions with NFPA and ASTM International technical committees.

R e l e va n c e of the N I OSH PPT P r o g r a m 67 One of the critical needs for improving protective clothing relates to the de- termination of parameters that may better reflect actual skin exposure as a result of permeation through the protective clothing. To this end, efforts are focused on assessing cumulative permeation of chemical warfare agents and toxic industrial chemicals and linking the results of these assessments to the development of der- mal exposure limits for those chemicals. A recent memorandum of understanding (MOU) between NIOSH and the Technical Support Working Group (TSWG) of the Department of Defense establishes collaborative efforts focused on understanding and defining risk-based permeation criteria. The InterAgency Board for Equip- ment Standardization and Interoperability (IAB) identified this topic as a priority for first responders. The PPT Program’s role in this partnership includes provid- ing input in the development of the permeation model, development and review of the skin permeation test plan, and the review of model predictions (NIOSH, 2007h). Other partners in the effort to develop permeation criteria include NFPA, ASTM International, the Canadian Royal Military College, and two private-sector companies. The development of standards and testing methods for a wider array of chemicals is needed and would offer a significant contribution to the goal of utiliz- ing quantitative risk assessment as input to developing and selecting appropriate chemical protective clothing. Relevant to the work on cumulative permeation for dermal risk assessment are the skin notation efforts under way in other divisions at NIOSH. While the work of the PPT Program will help determine the exposure variable of the risk equation, information on the hazard variable is also seriously lacking. To perform adequate quantitative risk assessments both exposure and hazard data are needed. The committee hopes that the skin notation work can be expanded to include more quantifiable characterization of dermal hazards. New initiatives are focused on examining the penetration of nanoparticles through protective clothing and on developing new approaches for measuring aero- sol particle penetration through protective clothing. The PPT Program is working with the Nanotech Consortium on this effort, and partners include private- and public-sector agencies and organizations. Emergency Response—PPT Needs and Physiologic Burden The PPT Program contracted with the International Association of Fire Fight- ers for a report that provided a detailed description of the PPT needs of firefight- ers and provided recommendations on research priorities for moving forward in addressing these evolving needs (IAFF, 2003). This report was used by the PPT Program and extramural researchers in developing research priorities and planning

68 The Personal Protective Technology Program at N I OSH research initiatives. Another report focused on reviewing gaps and limitations in test methods for firefighters and emergency responders (Barker, 2005). This report provided a basis for the PPT Program and extramural efforts to develop new test methods, including a test to evaluate stored energy effects in materials used in the construction of firefighter suits, and protocols for assessing physiological issues as- sociated with the performance of protective ensembles. The challenge with limited resources is to transfer these technologies and advances from firefighting to other work sectors (e.g., agricultural workers, welders, abrasive blasting). Physiological effects related to ergonomic factors are widely recognized as highly relevant in determining the performance of PPT used by emergency re- sponders. Research on the physiologic burdens of protective clothing has been a focus of research in the PPT Program, particularly related to firefighter ensembles and the work of the International Association of Fire Fighters’ collaborative effort Project HEROES® (Homeland Emergency Response Operational and Equipment Systems), in conjunction with TSWG, the Department of Homeland Security, the International Association of Fire Chiefs, the University of Massachusetts, the University of Arkansas, and a private-sector manufacturing company. The PPT Program’s research and testing efforts related to this project focus on assessing the physiologic burdens of firefighter ensembles. In 2005, the physiology laboratory was established by the PPT Program. The lab is used for this project as well as other measures of the physiologic burden of PPT. Recent research has focused on testing a number of cooling devices incorporated in protective clothing. Additional focus on the ergonomic aspects of protective clothing ensembles is key to future efforts. Research, conducted through collaboration with North Carolina State Univer- sity, has focused on the firefighter protective ensemble and the impact of stored thermal energy. This research is developing testing protocols designed to evaluate the effects of firefighter turn-out materials on skin burn injuries associated with exposure to certain thermal environments in structural firefighting operations. This research is relevant to addressing that hazard in the firefighting community. Results of the project will be used to implement this laboratory testing method in the NFPA 1971 Standard on Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting. The knowledge base is limited regarding the physiological burdens of PPT relevant to industry sectors beyond emergency responders; fur- ther efforts are needed to improve the PPT needs of other work sectors including agricultural and construction workers. Warning Devices As a part of its role in the NIOSH Fire Fighter Fatality Investigation and Pre- vention Program, the PPT Program has been involved in examining personal alert

R e l e va n c e of the N I OSH PPT P r o g r a m 69 safety system (PASS) equipment. PASS devices are important safety equipment for firefighters, sounding an audible alarm when firefighters are motionless or when activated by firefighters in trouble. This audible alarm helps other firefighters locate those in trouble. In 2005, NIOSH notified NFPA of several fatal firefighter incidents investigated by NIOSH in which the PASS device would have been expected to function, but was not heard or was barely audible. Reasons the PASS device may not have per- formed as designed were examined by NIOSH and by NIST. PPT Program staff participated in the NFPA Technical Committee on Electronic Safety Equipment to revise the relevant standards. The PPT Program continues to be involved, although with limited resources, in efforts to improve and enhance the reliability of PASS devices. Since NIOSH does not certify these devices it does not have the authority to recall older models of the device. New performance requirements in the revised NFPA standard only address the equipment certified to the new standard. Devices similar to PASS should be evaluated for use by the increasing number of workers who work alone, in confined spaces, or with limited communication options. Collaborations As evidenced by all of the above, the PPT Program works with numerous private- and public-sector partners to carry out its work on dermal PPT. Efforts to establish MOUs are activities that require time and resources and yield multiple benefits through the partnerships established. NIOSH has established a memoran- dum of understanding with ASTM and with NFPA and has several MOUs with the Technical Support Working Group including one to evaluate structural firefight- ing PPT with chemical or biological protection. In addition to partnerships with other agencies and organizations, another major way in which the PPT Program has made the most of its limited resources is through participation in consensus standards development efforts. PPT Program staff actively participate in ASTM, AIHA, and NFPA committees, and as described in Chapter 3, much of this par- ticipation has resulted in the development and refinement of consensus standards that improve the testing and certification of PPT. PPT Program staff have also been active in the work of the IAB, an organization focused on the equipment needs of first responders with an emphasis on chemical, biological, radiological, nuclear, or explosive issues. PPT Program staff members have served in leadership roles in the Interagency Board’s Federal Coordinating Committee and Personal Protective and Operational Equipment Subgroup. In 2005, the PPT Program, in collaboration with the Department of Industrial and Systems Engineering at Virginia Tech, sponsored the conference Advanced Per- sonal Protective Equipment: Challenges in Protecting First Responders, which brought

70 The Personal Protective Technology Program at N I OSH together more than 150 emergency responders to learn about new initiatives and to share ideas on next steps for PPT in this field (Virginia Tech, 2005). Committee Comments on Relevance to Occupational Safety and Health The PPT Program has effectively leveraged it minimal resources in the area of reducing exposure to dermal hazards, in terms of both planning and imple- mentation. By employing various worker and stakeholder forums to obtain input on the needs of the fire service and emergency responder communities, the PPT Program has refined the research agenda to focus on issues relevant to these worker communities. Further, the PPT Program has not only utilized its own intramural laboratory but also worked collaboratively with others in industry, academia, and professional associations to move forward in improving dermal PPT, particularly for the firefighter and emergency response communities. The PPT Program has developed a wide range of partnerships but might benefit from collaborations or consultations with the Human Factors and Ergonomics Society as well as others with expertise in human factors issues. The committee finds the PPT Program’s work on physiological challenges, ensemble testing, decontamination, and chemical permeation testing to be relevant to making progress in improving dermal protection. Research projects undertaken during the initial years of the PPT Program were fairly limited in scope and ap- proach, but recent efforts have made substantive progress in partnering with other agencies and organizations to conduct research that is more focused on improving worker safety and health. The risk assessment work based on cumulative permeation is a good start in a high-priority area. If this work is expanded to a wide variety of chemicals, and par- ticularly if it is coupled with dermal permeation work performed in other NIOSH divisions, it will make a significant contribution toward improving chemical pro- tective clothing. Because of limited information on the actual hazard that many chemicals pose to the skin and the lack of developed and standardized methods for assessing actual skin exposure, both with and without the use of chemical protec- tive clothing, most selection decisions have one of two outcomes: select the best chemical protective clothing based solely or mostly on permeation performance, or select the cheapest products that will not degrade when exposed. The former tends to ignore other selection factors such as dexterity, tactility, and puncture resistance. The latter ignores the fact that although degradation of chemical protective cloth- ing may not occur in use, permeation may lead to unacceptable skin exposures. Thus, better risk assessment data are needed both to improve the rationale for the selection of chemical protective clothing and to confirm that chosen products are indeed providing the anticipated protection.

R e l e va n c e of the N I OSH PPT P r o g r a m 71 To determine the effectiveness of chemical protective clothing, field perfor- mance evaluations are needed and should be expanded. Although laboratory per- meation tests are relative indicators of protection, in actual field use many other factors may modify the effectiveness of these products. Such factors include the construction of the protective clothing, temperature, exposures to chemical mix- tures, decontamination, and cleaning. The only way to be sure that chemical pro- tective clothing is working is to evaluate it in the field. Thus, techniques that are standardized, valid, reliable, and relatively easy to apply are needed. The PPT Program is helping to lead efforts to address the critical areas of ensemble testing and physiological effects of PPT. One of the challenges in de- veloping PPT is to address relevant gender and anthropometric differences that may affect the fit, wear, and use of the equipment. A recent PPT Program research study evaluated the physiological impact of the weight of firefighter footwear and included female test subjects. As the research on dermal PPT moves beyond effi- cacy and toward effectiveness, it will be critical to address a broad range of human factors (Chapter 4). Much of the work in dermal PPT has revolved around PPT for emergency re- sponders, with only minimal work done to address the needs of workers in other sectors. In large part, this has been the result of the PPT Program’s making best use of limited resources and connecting with partners in the emergency response community that have a heightened interest in PPT issues. However, the commit- tee recognizes that PPT needs vary widely among occupations—the needs of a pesticide applicator are quite different from those of a firefighter, as are the PPT needs of a nurse or of a pharmaceutical manufacturing worker. The committee urges wider efforts targeted at dermal PPT, with increased resources enabling the PPT Program to address the needs of a wide range of occupations across the broad spectrum of PPT. SURVEILLANCE A cornerstone program of PPT research, certification, and standards should be an active program of surveillance that produces information on occupational hazards and exposures, employer practices, and the use of PPT in the workplace. This strategy would be consistent with the overall emphasis that NIOSH places on surveillance as a foundation for its programs. Since its creation by the Occupational Safety and Health Act of 1970, NIOSH has emphasized a program of surveillance to track occupational injuries, illnesses, and hazards. Surveillance activities have often documented U.S. progress in reduc- ing the burden of work-related diseases and injuries, and have served to identify problems that require additional research and prevention efforts. Such efforts are

72 The Personal Protective Technology Program at N I OSH likely to translate into successful interventions in the workplace. However, rela- tively little attention has been paid to understanding the interaction between the particular exposures, hazards, and practices in the workplace that are relevant to optimizing personal protective technology. In the 1970s and 1980s, NIOSH spon- sored a national hazard survey and database. Then, in the late 1990s, the agency again considered options for producing information on hazards and exposures. The study of options by a multidisciplinary team of NIOSH staff representing various NIOSH organizations (the Respirator Surveillance Team) led to a decision to sponsor a national survey of respirator use in the workplace (Campbell et al., 1998). Thus, planning for the survey that would be conducted by the Bureau of Labor Statistics for NIOSH was well under way when NPPTL was founded. Planning and Production Inputs On an ongoing basis, the surveillance component is a small part of the PPT Program, accounting for about 3 percent of the overall PPT budget in FY 2007 and about the same in FY 2008. These funds support a small program that f ­ ocuses on analysis and dissemination of the 7-year-old findings of the national survey of respirator use in the workforce, developing an action plan to address the recommendations of a report provided by the National Academies (NRC, 2007), and respirator interventions at construction work sites in collaboration with industry groups. Activities and Outputs NIOSH surveillance and tracking data for the PPT Program have been funneled largely through one data source: the Bureau of Labor Statistics (BLS)-NIOSH 2001 nationwide respirator survey, Survey of Respirator Use and Practices (SRUP). The purpose of the survey was to help NIOSH better understand respirator and other PPT use and practices, with the ultimate goal of using interventions to improve respirator programs. The target population for the survey was private-sector res- pirator users with unemployment insurance programs who were included in the 1999 Survey of Occupational Injuries and Illnesses. The results of the survey were used to identify industries that have a high rate of respiratory protection use. The survey results also led to the conclusion that until adequate engineering controls are available and widely implemented, it is likely that respirators will continue to be used—especially in the construction sector. A survey report entitled Respirator Usage in Private Sector Firms (BLS and NIOSH, 2003) described the findings of the NIOSH-BLS survey.

R e l e va n c e of the N I OSH PPT P r o g r a m 73 In 2007, PPT researchers continued to mine the findings of this survey, pub- lishing numerous articles and making presentations at professional conferences to disseminate results across a number of different industries, including agricul- ture, forestry and fishing, manufacturing, construction, transportation, demoli- tion, and mining (NIOSH, 2007a). Findings were also specifically described with respect to existing employer programs and other aspects of optimizing respirator fit among workers. Overall, the survey report and subsequent publications and presentations provide a limited description of the state of respirator use and cor- responding programs in the workplace, as well as recommendations for future improvement. In the years since the SRUP survey, PPT Program researchers have also focused on developing a research protocol and follow-up research study as a next step toward gathering additional PPE surveillance data. Follow-up activities involved conducting focus groups and other work with the construction industry to identify intervention strategies. The PPT Program has concentrated on collaboration with industry groups to develop successful respirator program concepts that could be considered for application in the construction sector. Recently the PPT Program developed an action plan and framework for future surveillance work in conjunc- tion with other divisions at NIOSH (NIOSH, 2008h). Proposed efforts include building on existing surveys and potentially conducting a pilot study focused on PPT use in the healthcare and social assistance work sector. The efforts of the PPT Program to expand surveillance in order to better under- stand the interplay between hazards, exposure, and respirator use in the workplace are under the auspices of, and must be generally consistent with, the surveillance objectives of NIOSH. These objectives are outlined in the NIOSH Surveillance Strategic Plan (NIOSH, 2001), which calls for better coordination of surveillance activities between all federal and state agencies responsible for worker protection. The strategic plan also calls for a series of NIOSH-wide initiatives, such as the development of a comprehensive, nationally representative exposure survey and a national occupational exposure surveillance database. The plan affords the possibil- ity of leveraging the surveillance initiatives of NIOSH to inform the development of improved protective equipment. Committee Comments on Relevance to Occupational Safety and Health The committee believes that surveillance and dissemination efforts within the PPT Program have a high level of relevance. Further, the committee concludes that the results of the 2001 survey of respirator use in industry, while subject to some limitations outlined in a previous NRC report (NRC, 2007), nonetheless could

74 The Personal Protective Technology Program at N I OSH serve as a prototype for going forward as NIOSH structures the dissemination of new information about respirator use across industries and users. OVERALL ASSESSMENT OF RELEVANCE In considering the relevance of the PPT Program’s efforts, the committee exam- ined 12 of the program’s objectives across the three principal domains of research, respirator certification, and policy and standards setting. The committee took into account the major external factors, particularly the limited budget and the regula- tory mandate for respirator certification. The PPT Program operates in a set of multiple, small, partly refurbished laboratories dispersed over several acres. These facilities are inadequate for the challenges of overseeing the development of state- of-the-art PPT that must protect the health and safety of the nation’s workers. The respirator certification program is a premier function of the PPT Program. Since 2001, more than 1,600 respirators have been certified, and substantive progress is being made in meeting the congressional mandate of completing certification within 90 days. However, having a long-standing spotlight on respirators, compounded by budget limitations, constrains efforts to address other types of PPT (e.g., protective clothing, eye protection). Recent efforts, particularly in consensus standards setting, seem to be appropriately broadening the scope of the PPT Program. NIOSH is one of only a few federal agencies that has on-site certification test- ing responsibilities and facilities. Because OSHA and MSHA require employers to purchase only NIOSH-certified respirators, NIOSH certification is viewed by manufacturers and employers as a business necessity. NIOSH certification regula- tions are in use by other countries as a model or basis for their respirator certifica- tion efforts. The PPT Program conducts a limited number of product audits and conducts manufacturer site audits using both staff and external consultants. Efforts to ensure the effectiveness of respirators would be strengthened through increased resources that could be directed toward field testing and expedited revision of the federal certification regulations. The PPT Program has had well-documented success in its quick turnaround in developing the CBRN federal respirator standards. This effort involved extensive collaborative efforts with other federal agencies, nonprofit organizations, manu- facturers, and others. The PPT Program is in the midst of updating the regulations regarding the certification of mine self-rescue respirators. The PPT Program has conducted relevant research on total inward leakage, which is a major concern in respiratory protection, and on issues focused on criteria for powered air-purifying respirator regulations. However, the regulatory standards related to these issues are still in the initial stages of the rule-making process and expedited efforts are needed to move the process forward.

R e l e va n c e of the N I OSH PPT P r o g r a m 75 Consensus standards-setting activities are another priority area for the PPT Program and one in which staff members have been active in the technical com- mittees that are highly relevant to the program’s work. Participation in the devel- opment of ASTM, ANSI, NFPA, and ISO standards and test methods has been the primary mechanism for the PPT Program’s productive engagement in standards designed to reduce hazardous dermal exposures. PPT Program research has also contributed to test methods and performance standards for protective gear. The PPT Program is proactive in obtaining input from a range of stakehold- ers through a series of public meetings and manufacturers’ meetings focused on specific topics or proposed changes to the certification regulations. Website and listserv capabilities are utilized for dissemination of invitations to upcoming pub- lic meetings, user notices, the Certified Equipment List, guidelines, and other key information. In the last few years, the PPT Program has become active in collabo- rations with various federal agencies and other partners and has begun to explore links with extramural researchers. As discussed in its recommendations (Chapter 5), the committee urges a concentrated effort to bring the breadth of expertise in the extramural research community to bear on intramural and other pertinent PPT research questions. The time frame for the committee’s review began with the inception of NPPTL in 2001. In this relatively short period of time, the program has initiated a range of relevant research projects. Some of the projects are the result of opportunities driven by external factors and funding, whereas others have been initiated by PPT Program investigators. Recent research initiatives have focused on PPT for pan- demic influenza and others have focused on efforts to examine the as-yet largely unknown implications of exposure to the products and by-products of nanotech- nology. In addition to research to support and improve the respirator certification program (e.g., total inward leakage, anthropometrics), the committee suggests that the PPT Program address research in priority areas, particularly those for mining emergencies, dermal protection, and heat-related hazards. Limitations in the re- search budget are a major impediment to further improvements in PPT ensembles and in work that is needed across a range of occupations (e.g., agriculture, industry, construction, health care). While research has focused largely on engineering as- pects of PPT, one of the challenges to be addressed in the near future is improving and ensuring usability. This will require particular emphasis on increasing safety by improving the comfort, wearability, and individual and organizational incentives needed to ensure that workers do in fact wear PPT. On the basis of its review of the PPT Program’s work in research, certification, and policy and standards setting, the committee has assigned the NIOSH Personal Protective Technology Program a score of 4 for relevance. This score reflects the judgment that the PPT Program is working in priority areas and is engaged in

76 The Personal Protective Technology Program at N I OSH BOX 2-3 Scoring Criteria for Relevance 5 = The program’s work is in high-priority subject areas, and NIOSH is significantly en- gaged in appropriate transfer activities for completed projects or reported results. 4= The program’s work is in priority subject areas, and NIOSH is engaged in appropriate transfer activities for completed projects or reported results. 3= The program’s work is in high-priority or priority subject areas, but NIOSH is not engaged in appropriate transfer activities; or the focus is on lesser priorities, but NIOSH is engaged in appropriate transfer activities. 2= The program is focused on lesser priorities, and NIOSH is not engaged in or planning some appropriate transfer activities. 1= The program is not focused on priorities, and NIOSH is not engaged in transfer activities. transferring its research into improved products and processes (see Box 2-3 and Appendix A). In the judgment of the committee, the program, with additional resources and an expanded focus, could further improve its relevance score by strengthening the product and site audit programs; expediting revisions to the federal regulatory standards; better harnessing the capabilities of the extramural research community; and placing a stronger emphasis on comfort, wearability, and other human factors that affect workers’ use of PPT. REFERENCES Anthrotech. 2004. A head-and-face anthropometric survey of U.S. respirator users: Final report. Prepared by B. Bradtmiller and M. Friess for NIOSH/NPPTL. Barker, R. 2005. A review of gaps and limitations in test methods for first responder protective clothing. http://www.cdc.gov/niosh/npptl/pdfs/ProtClothEquipReview.pdf (accessed January 22, 2008). BLS (Bureau of Labor Statistics) and NIOSH (National Institute for Occupational Safety and Health). 2003. Respirator usage in private sector firms, 2001. http://www.cdc.gov/niosh/docs/respsurv/ (accessed January 22, 2008). Boord, L., and J. Dower. 2002. NIOSH CBRN respiratory protection standards update. International Society for Respiratory Protection, September 29-October 3, Edinburgh, Scotland. Campbell, D., A. ������������������������������������������������������������ Surveillance team report Dieffenbach, D. Groce, R. A. Jajosky, and G. Spransy. 1998. ������������������������������� to DRDS lead team. NIOSH. September 15. CDC (Centers for Disease Control and Prevention). 2001. 2nd National Stakeholders’ Meeting Report, April 10-11. http://www.cdc.gov /nedss/Archive/Stakeholder2/stakeholder_mtg_2.htm (accessed April 9, 2008).

R e l e va n c e of the N I OSH PPT P r o g r a m 77 Coffey, C. C., D. L. Campbell, W. R. Myers, Z. Zhuang, and S. Das. 1998a. Comparison of six respirator fit test methods with an actual measurement of exposure in a simulated health-care environment: Part I—Protocol development. American Industrial Hygiene Association Journal 59:852-861. Coffey, C. C., D. L. Campbell, W. R. Myers, Z. Zhuang, and S. Das. 1998b. Comparison of six respirator fit test methods with an actual measurement of exposure in a simulated health-care environment: Part II—Method comparison testing. American Industrial Hygiene Association Journal 59:862-870. Federal Register. 1972. 30 CFR Part 11, 12, 13, 14 and 14a. Federal Register 37(59). Frost and Sullivan Research Service. 2005. U.S. markets for respiratory protection equipment—Analyst presentation. http://www.frost.com/prod/servlet/report-brochure.pag?id=F160-01-00-00-00 (ac- cessed March 26, 2008). Gao, P., N. El-Ayouby, and J. T. Wassell. 2005. Change in permeation parameters and the decontamina- tion efficacy of three chemical protective gloves after repeated exposures to solvents and thermal decontaminations. American Journal of Industrial Medicine 47:131-143. Gardner, P., A. Richardson, K. Hofacre, and A. Rengasamy. 2006. Efficiency of respirator filters against a viral aerosol. Conference of the International Society for Respiratory Protection, August 28-31, Toronto, Canada. IAFF (International Association of Fire Fighters). 2003. PROJECT HEROES Homeland Emergency Response Operational and Equipment Systems, Task 1: A review of modern fire services hazards and protection needs. Presentation to the National Personal Protective Technology Laboratory. http://www.cdc.gov/niosh/npptl/pdfs/ProjectHEROES.pdf (accessed March 17, 2008). IOM (Institute of Medicine). 2006. Reusability of facemasks during an influenza pandemic. Washington, DC: The National Academies Press. IOM. 2007. Assessment of the NIOSH head-and-face anthropometric survey of U.S. respiratory users. Washington, DC: The National Academies Press. IOM. 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers. Washington, DC: The National Academies Press. IOM and NRC (National Research Council). 2006. Hearing loss research at NIOSH. Committee to Review the NIOSH Hearing Loss Research Program. Rpt. No. 1, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. Jacobs Facilities, Inc. 2002. Project development study for the National Personal Protective Technology Laboratory. Final Document, April 2002. Kim, S. C., M. S. Harrington, and D. Y. H. Pui. 2007. Experimental study of nanoparticles penetration through commercial filter media. Journal of Nanoparticle Research 9:117-125. King, B. H., A. M. Ruminski, J. L. Snyder, and M. J. Sailor. 2007. Optical-fiber-mounted porous sili- con photonic crystals for sensing organic vapor breakthrough in activated carbon. Advanced Materials 19(24):4530-4534. LaTourrette, T., D. J. Peterson, J. T. Bartis, B. A. Jackson, and A. Houser. 2003. Protecting emergency responders, Volume 2, Community views of safety and health risks and personal protection needs. http://rand.org/pubs/monograph_reports/2005/MR1646.pdf (accessed March 17, 2008). NIOSH. 2001. Tracking occupational injuries, illnesses, and hazards: The NIOSH surveillance strategic plan. http://www.cdc.gov/niosh/pdfs/2001-118.pdf (accessed March 19, 2008). NIOSH. 2004a. Program concept for total inward leakage (TIL) performance requirements and test methods. http://www.cdc.gov/niosh/npptl/standardsdev/til/ (accessed March 5, 2008). NIOSH. 2004b. NIOSH respirator selection logic 2004. http://www.cdc.gov/niosh/docs/2005-100/ ( ­ accessed March, 16, 2008).

78 The Personal Protective Technology Program at N I OSH NIOSH. 2004c. Air-purifying escape hood respirators (escape hoods): Interim findings and guidance for models put into use prior to NIOSH CBRN Certification Standards. http://www.cdc.gov/niosh/ npptl/guidancedocs/interesc0404.html (accessed March 18, 2008). NIOSH. 2005a. Strategic plan for NIOSH nanotechnology research: Filling the knowledge gaps. http:// www.cdc.gov/niosh/topics/nanotech/strat_plan.html (accessed March 3, 2008). NIOSH. 2005b. Breakthrough 2004. http://www.cdc.gov/niosh/docs/2005-125/ (accessed March 17, 2008). NIOSH. 2005c. CBRN APR interim guidance. http://www.cdc.gov/niosh/npptl/guidancedocs/ interesc0404.html (accessed March 18, 2008). NIOSH. 2006. Self-contained self-rescuer long term field evaluation: Combined eighth and ninth phase results. http://www.cdc.gov/niosh/mining/pubs/pubreference/outputid2120.htm (accessed March 16, 2008). NIOSH. 2007a. NIOSH personal protective technology program: Evidence for the National Acad- emies committee to review the NIOSH personal protective technology program. Pittsburgh, PA: NIOSH. NIOSH. 2007b. PPT Program response to questions to NIOSH: Working Group 1. Distributed to the Committee to Review the NIOSH Personal Protective Technology Program, November 14, 2007 (available through the National Academies Public Access File). NIOSH. 2007c. Certification application processing history, FY 2003-2007. NIOSH response to inquiry regarding respirator certification numbers, December 13, 2007 (available through the National Academies Public Access File). NIOSH. 2007d. Approaches to safe nanotechnology. http://www.cdc.gov/niosh/topics/nanotech/ safenano/control.html (accessed March 4, 2008). NIOSH. 2007e. MultiVapor. http://www.cdc.gov/niosh/npptl/multivapor/multivapor.html (accessed March 17, 2008). NIOSH. 2007f. Long-term field evaluation concept. http://www.cdc.gov/niosh/review/public/NPPTL- LTFE/ (accessed March 17, 2008). NIOSH. 2007g. Final manufacturer/customer survey results. http://www.cdc.gov/niosh/npptl/default. html (accessed March 18, 2008). NIOSH. 2007h. PPT Program response to questions to NIOSH: Working Group 3. Distributed to the Committee to Review the NIOSH Personal Protective Technology Program, December 5, 2007 (available through the National Academies Public Access File). NIOSH. 2008a. Budget information on mining projects. NIOSH response to committee questions, November 14, 2007 (available through the National Academies Public Access File). NIOSH. 2008b. Permeation calculator. http://www.cdc.gov/niosh/npptl/PermeationCalculator/ permeationcalc.html (accessed January 17, 2008). NIOSH. 2008c. Skin exposures and effects. www.cdc.gov/niosh/topics/skin/ (accessed January 22, 2008). NIOSH. 2008d. PPT Program response to January 4, 2008 IOM request. Distributed to the Commit- tee to Review the NIOSH Personal Protective Technology Program, January 30, 2008 (available through the National Academies Public Access File). NIOSH. 2008e. PPT Program FTE summary. Submitted by Maryann D’Alessandro via e-mail February 2, 2008. (available through the National Academies Public Access File). NIOSH. 2008f. NPPTL facial anthropometrics research roadmap. http://www.cdc.gov/niosh/review/ public/111/ (accessed March 4, 2008). NIOSH. 2008g. Personal protective equipment (PPE) for healthcare workers action plan. http://www. cdc.gov/niosh/review/public/129/ (accessed March 5, 2008).

R e l e va n c e of the N I OSH PPT P r o g r a m 79 NIOSH. 2008h. PPT surveillance program action plan. Draft, March 5, 2008 (available through the National Academies Public Access File). NIOSH. 2008i. Estimated timeline for 42 CFR Part 84 rulemaking, March 11, 2008 (available through the National Academies Public Access File). NIOSH. 2008j. Certified equipment list. http://www.cdc.gov/niosh/npptl/topics/respirators/cel/ (ac- cessed March 16, 2008). NIOSH. 2008k. CBRN respirator standards development. http://www.cdc.gov/niosh/npptl/standardsdev/ cbrn/default.html (accessed March, 17, 2008). NIOSH. 2008l. Office of Extramural Programs, grants process. http://www.cdc.gov/niosh/oep/grants. html (accessed March 18, 2008). NIOSH. 2008m. Respirator testing. http://www.cdc.gov/niosh/npptl/stps/Respirator_Testinghtm#STP_ APR (accessed March 18, 2008). NIOSH. 2008n. Powered air-purifying respirator concept paper. http://www.cdc.gov/niosh/npptl/ resources/pressrel/letters/lttr-010308.html (accessed March 19, 2008). NIOSH. 2008o. Email from Maryann D’Alessandro, March 26 (available through the National Acad- emies Public Access File). NIOSH. 2008p. Fire Fighter Fatality Investigation and Prevention Program. http://www.cdc.gov/niosh/ fire/implweb.html (accessed April 7, 2008). NIOSH. 2008q. Program concept for total inward leakage (TIL) performance requirements and test methods. http://www.cdc.gov/niosh/npptl/standardsdev/til/ (accessed March 19, 2008). NPPTL (National Personal Protective Technology Laboratory). 2007. Letter to all respirator manufac- turers, Subject: Revised fees for CBRN respirator approvals, effective April 1, 2007. http://www.cdc. gov/niosh/npptl/resources/pressrel/letters/lttr-031103b.html (accessed March 25, 2008). NRC. 2007. Measuring respirator use in the workplace. Washington, DC: The National Academies Press. NRC and IOM. 2007. Mining safety and health research at NIOSH. Committee to Review the NIOSH Min- ing Safety and Health Research Program. Rpt. No. 2, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. NRC and IOM. 2008a. Agriculture, forestry, and fishing research at NIOSH. Committee to Review the NIOSH Agriculture, Forestry, and Fishing Research Program. Rpt. No. 3, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. NRC and IOM. 2008b. Respiratory disease research at NIOSH. Committee to Review the NIOSH Re- spiratory Disease Research Program. Rpt. No. 4, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press. Ramani, R., et al. 2003. A compilation of personal protective equipment guidelines for emergency r ­ esponders. Pittsburgh, PA: NIOSH. Rengasamy, S., R. Verbofsky, W. P. King, and R. Shaffer. 2007. Nanoparticle penetration through NIOSH-approved N95 filtering facepiece respirators. Journal of the International Society for Respiratory Protection 24:49-54. Roberge, R. J. 2008a. Evaluation of the rationale for concurrent use of N95 filtering facepiece respi- rators with loose-fitting powered air-purifying respirators during aerosol-generating medical procedures. American Journal of Infection Control 36(2):135-141. Roberge, R. J. 2008b. Effect of surgical masks worn concurrently over N95 filtering facepiece respira- tors: Extended service life versus increased user burden. Journal of Public Health Management and Practice 14(2):E19-E26.

80 The Personal Protective Technology Program at N I OSH Virginia Tech. 2005 Advanced personal protective equipment: Challenges in protecting first responders. http://www.cpe.vt.edu/appe/program.html (accessed January 22, 2008). Vo, E. 2004. Application of colorimetric indicators and thermo-hand method to determine base permeation through chemical protective gloves. Journal of Occupational and Environmental Hygiene 1(12):799-805. Wood, G. O. 2004. Estimating service lives of organic vapor respirator cartridges at all relative humidi- ties. Journal of Occupational and Environmental Hygiene 1(7):472-492. Wood, G. O. 2005. Estimating service lives of air-purifying respirator cartridges for reactive gas re- moval. Journal of Occupational and Environmental Hygiene 2(8):414-423. Zhuang, Z., and B. Bradtmiller. 2005. Head-and-face anthropometric survey of U.S. respirator users. Journal of Occupational and Environmental Hygiene 2(11):567-576. Zhuang, Z., B. Bradtmiller, and R. E. Shaffer. 2004. New respirator fit test panels representing the cur- rent U.S. civilian workforce. International Society for Respiratory Protection, November 9-12, Yokohama, Japan. Zhuang, Z., L. M. Williams, D. J. Viscusi, and R. E. Shaffer. 2005. Facial anthropometric differences among race/age groups. American Industrial Hygiene Conference, May 23-26, Anaheim, CA. Zhuang, Z., D. J. Viscusi, and A. Reddington. 2006. Anthropometrics for developing headforms for testing respiratory and eye protective devices. International Society for Respiratory Protection, August 27-September 1, Toronto, Canada. Zhuang, Z., B. Bradtmiller, and R. Shaffer. 2007. New respirator fit test panels representing the current U.S. civilian workforce. Journal of Occupational and Environmental Hygiene 4:647-659.

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Maintaining the health and safety of workers in the United States and globally is accomplished in part by reducing hazardous exposures through the use of personal protective equipment. Personal protective technologies (PPT) include respirators worn by construction workers and miners; protective clothing, respirators, and gloves worn by firefighters and mine rescue workers; and respirators and protective clothing worn by healthcare workers. An estimated 5 million workers are required to wear respirators in 1.3 million U.S. workplaces. For some occupations, such as firefighting, the worker's protective equipment is the only form of protection against life-threatening hazards; for other workers, the PPT is a supplement to ventilation and other environmental, engineering, or administrative hazard controls.

In the United States, federal responsibility for civilian worker PPT is integral to the mission of the National Institute for Occupational Safety and Health (NIOSH). This book examines the NIOSH Personal Protective Technology Program (PPT Program) and specifically focuses on the relevance and impact of this program in reducing hazardous exposures and improving worker health and safety.

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