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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 2 Relevance of the NIOSH PPT Program The committee began its assessment of the relevance of the Personal Protective 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 2001.1 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 programs 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. 1 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).
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 encompass 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). FIGURE 2-1 PPT Program funding by year and source (million dollars). SOURCE: NIOSH, 2007a.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health FIGURE 2-2 PPT Program budget FY 2001-2007. SOURCE: NIOSH, 2007a. To gain further insights into the allocation of the funding resources, the committee 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) activities2 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 equivalent (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 2 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 devies 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health nature 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 located 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-initiated 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
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health (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 reported 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), cooperative 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 congressionally 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 certification 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 appropriated 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 procedure 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 FIGURE 2-3 Funding sources for respirator certification by fiscal year. SOURCE: NIOSH, 2007b.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 respirators 0 $183,800 $104,450 $120,850 $140,000 $130,150 $280,990 CBRN respiratorsa 0 $7,000 $9,300 $53,200 $45,020 $196,842 $196,829 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 approximately $6.39 million (Table 2-2). Of that amount, only $477,819 (approximately 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
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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. Additionally, two contract employees and one NIOSH FTE provide administrative support. It should be noted that while the PPT Program has the personnel, facilities, equipment, 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 applications 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 federal 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 improved testing and certification methodologies. Current research efforts include the enhancement of existing technology to support respirator certification (total inward
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 implementation. 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 approach, 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 particularly if it is coupled with dermal permeation work performed in other NIOSH divisions, it will make a significant contribution toward improving chemical protective 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 protective 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 clothing 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health To determine the effectiveness of chemical protective clothing, field performance evaluations are needed and should be expanded. Although laboratory permeation 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 mixtures, decontamination, and cleaning. The only way to be sure that chemical protective 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 developing 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 efficacy 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 responders, 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 committee 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 reducing the burden of work-related diseases and injuries, and have served to identify problems that require additional research and prevention efforts. Such efforts are
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health likely to translate into successful interventions in the workplace. However, relatively 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 sponsored 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 focuses 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 respirator 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health In 2007, PPT researchers continued to mine the findings of this survey, publishing numerous articles and making presentations at professional conferences to disseminate results across a number of different industries, including agriculture, forestry and fishing, manufacturing, construction, transportation, demolition, 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 corresponding 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 conjunction 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 understand 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 possibility 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
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 examined 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 regulatory 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 testing 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 regulations are in use by other countries as a model or basis for their respirator certification 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, manufacturers, 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.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health Consensus standards-setting activities are another priority area for the PPT Program and one in which staff members have been active in the technical committees that are highly relevant to the program’s work. Participation in the development 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 stakeholders 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 public meetings, user notices, the Certified Equipment List, guidelines, and other key information. In the last few years, the PPT Program has become active in collaborations 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 pandemic influenza and others have focused on efforts to examine the as-yet largely unknown implications of exposure to the products and by-products of nanotechnology. 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 research 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 aspects 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
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health BOX 2-3 Scoring Criteria for Relevance 5 = The program’s work is in high-priority subject areas, and NIOSH is significantly engaged 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. Dieffenbach, D. Groce, R. A. Jajosky, and G. Spransy. 1998. Surveillance team report 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).
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 Academies 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 Committee 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).
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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/ (accessed 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 Academies 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 manufacturers, 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 Mining 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 Respiratory 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 responders. 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 respirators 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 respirators: Extended service life versus increased user burden. Journal of Public Health Management and Practice 14(2):E19-E26.
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The Personal Protective Technology Program at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 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 humidities. 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 removal. 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 current 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.