Summary

ABSTRACT Protecting millions of workers from occupational hazards frequently involves the use of respirators, protective clothing, gloves, or other personal protective technologies (PPT). For some occupations, such as firefighting, the worker’s protective equipment is the only form of protection against life-threatening hazards, while for others, such as healthcare workers, PPT is one component in a series of protective controls.

In conjunction with a series of planned reviews of National Institute for Occupational Safety and Health (NIOSH) research programs, the Institute of Medicine (IOM) and the National Research Council (NRC) convened a committee of experts to review the NIOSH Personal Protective Technology Program (PPT Program) to evaluate the relevance of its work to improvements in occupational safety and health and the impact of its work in reducing workplace illnesses and injuries. Relevance was evaluated based on the priority of work carried out and the strength and plausibility of its association with improvements in workplace protection. Impact was evaluated based on contributions to intermediate and end outcomes linked to worker health and safety. The committee was also asked to assess the program’s targeting of new research areas, identify emerging issues in PPT, and provide recommendations for strengthening the program. In addition to reviewing the PPT research efforts, the committee’s task included evaluating the respirator certification program and appraising the policy and standards development efforts of the PPT Program.



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Summary ABSTRACT Protecting millions of workers from occupational hazards fre- quently involves the use of respirators, protective clothing, gloves, or other per- sonal protective technologies (PPT). For some occupations, such as firefighting, the worker’s protective equipment is the only form of protection against life- threatening hazards, while for others, such as healthcare workers, PPT is one component in a series of protective controls. In conjunction with a series of planned reviews of National Institute for Occupational Safety and Health (NIOSH) research programs, the Institute of Medicine (IOM) and the National Research Council (NRC) convened a committee of experts to review the NIOSH Personal Protective Technology Program (PPT Program) to evaluate the relevance of its work to improve- ments in occupational safety and health and the impact of its work in reduc- ing workplace illnesses and injuries. Relevance was evaluated based on the priority of work carried out and the strength and plausibility of its association with improvements in workplace protection. Impact was evaluated based on contributions to intermediate and end outcomes linked to worker health and safety. The committee was also asked to assess the program’s targeting of new research areas, identify emerging issues in PPT, and provide recommendations for strengthening the program. In addition to reviewing the PPT research efforts, the committee’s task included evaluating the respirator certification program and appraising the policy and standards development efforts of the PPT Program. 

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the peRsonal pRotectIve technology pRogRam nIosh at  Taking into account several important factors beyond the program’s con- trol, the committee found that since 00 (the period covered by this review), the PPT Program has made meaningful contributions to improving worker health and safety. Using a five-point scoring scale (where 5 is highest), the committee assigned the NIOSH PPT 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 transferring its research to improved products and processes. The committee also assigned the PPT Program a score of 4 for impact, indi- cating that the program has made probable contributions to end outcomes (improvements in worker health or safety) in addition to well-accepted inter- mediate outcomes. To enhance the relevance and impact of its work, the committee recom- mends the development of a National PPT Program consistent with the origi- nal congressional mandate that would foster the development of improved protection for all workers through coordinated oversight of all PPT. The committee also recommends that the PPT Program establish research centers of excellence, enhance the respirator certification process, increase research on the use and usability of PPT, and assess PPT use and effectiveness in the workplace using a life-cycle approach. OVERVIEW M aintaining 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 technolo- gies (PPT) include respirators worn by construction workers and miners to protect against exposure to silica, dust, and hazardous gases; protective clothing, respirators, and gloves worn by firefighters and mine rescue workers to avoid burns and smoke inhalation; and respirators and protective clothing worn by healthcare workers to prevent acquiring an infectious disease. 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, 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 report 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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summaRy  STUDY PROCESS In September 2004, NIOSH requested that the National Academies conduct evaluation reviews of specific NIOSH programs to assess the relevance and the im- pact of the work of NIOSH in reducing workplace injury and illness. For consistency across the set of evaluations, each evaluation review is using a methodology and framework developed by the National Academies’ Committee to Review NIOSH Research Programs. In July 2007 the Institute of Medicine and the Division on Earth and Life Studies of the National Research Council formed the Committee to Review the NIOSH Personal Protective Technology Program. The committee included members with expertise in occupational health, emergency response, health care, personal protective equipment manufacturing, employee organizations, respiratory protection, dermal protection, injury protection, and program evaluation. The committee was tasked with reviewing the NIOSH PPT Program and evalu- ating the program’s relevance to and impact on occupational health and safety. In addition to reviewing PPT-related research programs, the committee’s task included evaluating the certification and the standards development efforts of the PPT Program. Further, the committee was tasked with focusing its efforts on PPT relevant to respiratory and dermal hazards (Box S-1) as NIOSH efforts relevant to other types of PPT (e.g., hearing loss, fall prevention) are being addressed in other National Academies’ reviews. The study committee was given the discretion to determine the time period to be covered by the review and chose to focus its evaluation from the inception of the NIOSH National Personal Protective Technol- ogy Laboratory (NPPTL) in 2001 through 2007. THE NIOSH PPT PROGRAM Personal protective technologies are defined as the specialized clothing or equipment worn by individuals for protection against health and safety hazards, as well as the technical methods, processes, techniques, tools, and materials that support their development, evaluation, and use. PPT encompasses personal pro- tective equipment products such as respirators, gloves, protective eyewear, hearing protection, and protective clothing but also includes facepieces, filters, guidance documents, standards, and test procedures. NIOSH’s PPT Program works to fulfill its mission through three major areas of endeavor: (1) respirator certification as mandated in federal regulations; (2) re- search focused on protection from respiratory, dermal, and injury hazards; and (3) participation in standards setting and policy making. Workplaces regulated by the Occupational Safety and Health Administration (OSHA) or the Mine Safety and Health Administration (MSHA) in the United States with hazardous respiratory

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the peRsonal pRotectIve technology pRogRam nIosh at 4 BOX S-1 PPT Program Strategic Goals and Objectives Strategic Goal 1: Reduce Exposure to Inhalation Hazards Objective 1. Ensure the integrity of the national inventory of respirators through the implementation of a just-in-time respirator certification process. Objective 2. Develop CBRN respirator standards to reduce exposure to CBRN threats. Objective 3. Ensure the availability of mine emergency respirators for escape from mines. Objective 4. 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. Objective 5. Quantify the impacts of various personal protective equipment on viral transmission. Objective 6. Evaluate the nanofiber-based fabrics and NIOSH-certified respirators for respiratory protection against nanoparticles. Objective 7. Develop and make available end-of-service-life indicator (ESLI) technologies that reliably sense or model performance to ensure respirator users receive effective respiratory protection. Objective 8. Gather information on the use of respirators in the workplace to identify research, intervention, and outreach needs. Strategic Goal 2: Reduce Exposure to Dermal Hazards Objective 1. Improve chemical-barrier protective clothing testing and use practices to reduce worker exposure to chemical dermal hazards. Objective 2. Improve emergency responder protective clothing to reduce exposure to thermal, biological, and chemical dermal hazards. Objective 3. Investigate physiological and ergonomic impact of protective ensembles on individual wearers in affecting worker exposure to dermal hazards. Strategic Goal 3: Reduce Exposure to Injury Hazards* Objective 1. Develop and evaluate warning devices for fire services. NOTE: CBRN = chemical, biological, radiological, and nuclear. *The PPT Program has additional objectives under this strategic goal that are related to hearing protection, protection from falls, and antivibration technologies. These objectives are not the focus of this review; some aspects of these objectives have been discussed in other National Academies’ reviews.

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summaRy 5 exposures must meet federal requirements to provide their workers with NIOSH- certified respirators.1 To achieve NIOSH certification, manufacturers submit respi- rator products to NPPTL, where the products undergo a series of certification tests depending on the type of respirator and its intended use. Products that successfully meet the design, quality, and performance certification criteria are designated and approved as NIOSH-certified respirators. Intramural research is conducted primar- ily in the more than 20 laboratory facilities located in Bruceton, Pennsylvania, near Pittsburgh. In addition, research is conducted through contracts with universities and other partners. The NIOSH extramural research program is administered through the NIOSH Office of Extramural Programs and is largely separate from the intramural program. The PPT Program’s research portfolio is focused on respira- tory research relevant to PPT, with a smaller but growing component of research on protective clothing and other types of PPT. NIOSH’s work in PPT also involves participating in the development of relevant regulatory standards and consensus standards. Consensus standards for the manufacturing, performance, and testing of PPT products are developed by national and international standards development organizations. These organizations work through expert committees consisting of representatives from government agencies, manufacturers, employers, academia, and end users. 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. Approximately one-third of the PPT Program’s budget is designated for federally mandated respirator certification testing. 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 Pro- gram. Since 2001, more than 1,600 respirators have been certified and substantive progress is being made in meeting the congressional mandate of completing cer- tification within 90 days. However, having a long-standing spotlight on respira- tors, compounded by budget limitations, constrains efforts to address other types 1The Mine Safety and Health Administration (MSHA) is also involved in certifying certain mine escape equipment, and the Department of Defense has criteria specific to PPT for the military workforce.

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the peRsonal pRotectIve technology pRogRam nIosh at  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 onsite 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 chemical, biological, radiological, and nuclear (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 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. Consensus standards-setting activities are another priority area for the PPT Program and one in which it has been active through the technical committees that are highly relevant to the program’s work. Participation in the development of ASTM (formerly, American Society for Testing and Materials) International, NFPA (National Fire Protection Association), and ISO (International Organization for Standardization) standards and test methods has been the primary mechanism for the PPT Program’s productive engagement in standards designed to reduce hazard- ous 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 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,

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summaRy  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 the 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 oppor- tunities driven by external factors and funding, while 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., agri- culture, industry, construction, health care). While research has focused on engi- neering 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 increas- ing 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, certifica- tion, and policy and standards setting, the committee has assigned the NIOSH Personal Protective Technology Program a score of 4 for relevance (Box S-2). This BOX S-2 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.

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the peRsonal pRotectIve technology pRogRam nIosh at  score reflects the judgment that the PPT Program is working in priority areas and is engaged in transferring its research into improved products and processes. 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. ASSESSMENT OF IMPACT NIOSH is nationally and internationally recognized for its respirator cer- tification program. OSHA and MSHA require that the respirators used in U.S. workplaces be NIOSH-certified. The PPT Program also took a leadership role in developing and expediting federal regulatory standards for CBRN respirators. This effort involved extensive collaboration with multiple federal agencies, manufactur- ers, and professional associations. For example, OSHA and NIOSH collaboratively developed a CBRN PPT Selection Matrix for Emergency Responders. Impacts on reducing hazardous exposures or preventing illness or injury are difficult to attribute directly to the work of a single federal agency. However, be- cause the PPT Program certifies that respirators meet a number of rigorous, pre- specified performance criteria, the committee felt justified in acknowledging that positive end outcomes have occurred that are attributable to the PPT Program’s role in respirator certification. For workers who have few other protections from hazardous workplace exposures, such as firefighters, the value of effective PPT is a daily reality. As noted above, successful mine escapes have occurred because the miners had access to effective respirators that prevented exposure to lethal levels of carbon monoxide. Having such equipment in place involves the collaborative efforts of manufacturers, professional associations, employers, employees, unions, state and federal agencies, and many others. However, the committee recognizes the central and vital role that the PPT Program plays in this effort. Important intermediate outcomes also appear to be the result of active partici- pation by PPT Program staff members in consensus standards-development efforts. The PPT Program has leveraged its limited resources well in its participation in na- tional and international consensus standards organizations. Several recent ISO and ASTM International standards have incorporated test methods developed through PPT Program research. The PPT Program staff has also led or been instrumental in research on a number of key issues, although, as in several other important areas, budget restraints substantially limit the extent of research efforts. Work on protection against viral transmission (particularly related to pandemic influenza)

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

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the peRsonal pRotectIve technology pRogRam nIosh at 0 by applying the lessons learned in the development of CBRN respirator standards to other types of PPT (e.g., protective clothing, protective eyewear, gloves) and emphasizing development and testing of protective ensembles and other integrated approaches to PPT. EMERGING AREAS In addition to examining the relevance and impact of the work of the NIOSH PPT Program, the committee was asked to examine the process by which the pro- gram identifies new research areas and to provide ideas on additional topics. The committee recognizes the many inputs to the PPT Program’s process for establish- ing research priorities. The PPT Program sets its research and other institutional priorities through an ongoing strategic planning process that culminates in an annual planning summit attended by the governance team comprised of key PPT Program managers. Inputs to the planning process include the many public and manufacturers’ meetings sponsored by the PPT Program that have recently been expanded to focus on a broader range of PPT efforts including hearing loss and fall prevention. The PPT Program has been very successful in engaging specific and familiar stakeholder groups, including respirator manufacturers and the emergency response community, and recognizes the need to expand into other work sec- tors. The PPT Program has demonstrated its engagement in PPT policy develop- ment through participation in consensus standards development committees and through its interactions with other federal agencies. The PPT Program’s process for identifying and addressing emerging areas seems quite open and transparent, and the committee urges the program to con- tinue in this manner as it reaches out to other workplace sectors. The PPT Program would also benefit from further expertise in behavioral sciences and interdisciplin- ary specialties, aimed principally at human factors. Given the ongoing challenges of workers’ noncompliance with PPT use, it is paramount that NIOSH recognize psychosocial, usability, comfort, and behavioral issues that profoundly modify the relationship between PPT design and user compliance. The committee was not given the task of conducting a comprehensive assess- ment of all emerging issues in PPT, but it did identify several overarching consid- erations pertinent to all types of PPT: new materials technologies, usability and human factors, PPT ensembles and systems integration, enhancing a culture of workplace safety, and training and professional education. RECOMMENDATIONS The NIOSH PPT Program has made effective use of its limited resources and has moved the research, standards-setting, and certification agendas forward,

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summaRy  largely with a focus on respirators. However, much still has not been done due to serious budgetary constraints. The committee offers the following recommenda- tions (Box S-4) with the goal of improving the ability of the NIOSH PPT Program to broaden its scope and depth of responsibility in order to protect workers more effectively from hazardous workplace exposures, illness, injuries, and disease. BOX S-4 Summary of Report Recommendations Recommendation 1: Implement and Sustain a Comprehensive National Personal Protective Technology Program NIOSH should work to ensure the implementation of the 2001 congressional mandate for a comprehensive state-of-the-art federal program focused on personal protective technology. A comprehensive program would build on the current NIOSH PPT Program and would bring unified responsibility and oversight to all PPT-related activity at NIOSH. Recommendation 2: Establish PPT Research Centers of Excellence and Increase Extramural PPT Research The PPT Program should establish and sustain extramural PPT centers of excellence and work to increase other extramural research opportunities. Recommendation 3: Enhance the Respirator Certification Process The PPT Program should continue to improve the respirator certification process. The program should expedite the revision of the respirator certification regulations, develop a mechanism for registering the purchase of NIOSH-certified respirators, expand the product audit program, monitor the site audit program, and disseminate respirator certification test result data. Recommendation 4: Increase Research on the Use and Usability of PPT The PPT Program should intensify its research directed at barriers to and facilitators of PPT use by workers. Such research should examine human factors and ergonomics, as well as individual behaviors and organizational behaviors, particularly workplace safety culture. Recommendation 5: Assess PPT Use and Effectiveness in the Workplace Using a Life-Cycle Approach The PPT Program, in collaboration with relevant NIOSH divisions and other partners, should oversee an ongoing surveillance and field testing program to assess PPT use and effective- ness in the workplace. These efforts should emphasize a life-cycle approach by including both pre-market and interval post-market testing of PPT and include data collection on issues ranging from training to decontamination.

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the peRsonal pRotectIve technology pRogRam nIosh at  Recommendation 1: Implement and Sustain a Comprehensive National Personal Protective Technology Program NIOSH should work to ensure the implementation of the 2001 congressional mandate for a comprehensive state-of-the-art federal program focused on personal protective technology. A comprehensive program would build on the current NIOSH PPT Program and would bring unified responsibility and oversight to all PPT-related activity at NIOSH. The National Personal Protective Technology Program should • Oversee, coordinate, and where appropriate, conduct research across all types of occupational PPT and across all relevant occupations and workplaces; • Participate in policy development and standards setting across all types of occupational PPT; • Oversee all PPT certification in order to ensure a minimum uni- form standard of protection and wearability. The National Program should collaborate with other relevant government agencies, private- sector organizations, and not-for-profit organizations to conduct an assessment of the certification mechanisms needed to ensure the efficacy of all types of PPT; and • Promote the development, standards setting, and certification of effectively integrated PPT components and ensembles in which mul- tiple types of PPT (e.g., eye protection, hearing protection, respira- tors) can be effectively and seamlessly worn together. The committee was struck by the discordance between the congressional man- date2 to establish the National Personal Protective Technology Laboratory (NPPTL) in 2001 and the challenges faced by the current PPT Program, which focuses almost solely on respiratory PPT because of limited resources. If NIOSH is to respond fully to its 2001 congressional directive to develop and test state-of-the-art national PPT needs (respirators, protective clothing, gloves, hearing protection, eye protection, and other types of PPT) across all relevant work sectors, then a more comprehen- sive approach is needed. 2Senate Report 106-293 stated “It has been brought to the Committee’s attention the need for design, testing and state-of-the-art equipment for this nation’s 50 million miners, firefighters, health- care, agricultural and industrial workers. . . . The Committee encourages NIOSH to carry out re- search, testing and related activities aimed at protecting workers, who respond to public health needs in the event of a terrorist incident. The Committee encourages CDC [the Centers for Disease Control and Prevention] to organize and implement a national personal protective equipment laboratory.”

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summaRy  As PPT becomes increasingly complex, integration of its many components re- quires scrupulously coordinated development of interfaces and ensembles that are designed, standardized, and certified under the oversight of a single entity within NIOSH, dedicated solely to PPT in the workplace. To promote worker safety by in- tegrating various types of protective equipment requires placing the responsibility for all PPT efforts at NIOSH under a single entity that has the responsibility and the requisite resources to oversee the broad array of PPT and to lead the efforts to provide workers with improved and innovative protective equipment. In 2005, NIOSH took a significant first step toward coordinating PPT-related efforts across the institute by establishing the PPT Program and developing a matrix approach to management. However, the committee is concerned that the current matrix structure of PPT efforts at NIOSH is too ambiguously configured to serve the long-term needs and flexible goals of a comprehensive, coordinated national PPT endeavor. Although designated as a program in name, the directors of the current PPT Program have limited budgetary authority and management responsibility for PPT research and other efforts outside of NPPTL. As a result of the lack of a single authority there are major gaps in integration, coordination, and consolidation of many types of PPT. The current matrix approach, while a good first step, does not bring the full depth and range of NIOSH expertise to bear on moving forward in improving and coordinating PPT at the national level. The committee believes that a meaningfully integrated approach to improving all types of occupational PPT would logically require consolidation of the oversight responsibilities for PPT efforts at NIOSH. The committee’s emphasis in response to its charge was on proposing a general strategy intended to optimize the wealth of relevant expertise at NIOSH in order to meet the new challenges of develop- ing fully integrated and coordinated protective ensembles and technologies for worker protection. Approaches could range from maintaining current laboratory and research facilities with changes in reporting and budgetary authority to more major organizational changes. Carrying out the original congressional intent of an effort focused on “the design, testing, and state-of-the-art [personal protective] equipment for this nation’s . . . workers” (Senate Report 106-293) will necessitate a commitment to a broad scope of work and collaborative efforts. Recommendation 2: Establish PPT Research Centers of Excellence and Increase Extramural PPT Research The PPT Program should establish and sustain extramural PPT centers of excellence and work to increase other extramural research opportunities. The PPT Program should

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the peRsonal pRotectIve technology pRogRam nIosh at 4 Develop and support research centers of excellence that work closely • with the NIOSH intramural research program to improve PPT, in- crease field research, and explore and implement research to practice interventions; and • Work with the NIOSH Office of Extramural Programs to increase other research opportunities and enhance collaboration and aware- ness of relevant PPT research efforts among intramural and extra- mural researchers. The community of extramural scientists is a highly valuable resource for improving PPT. It is critical that this breadth and depth of expertise is focused on important PPT research questions relevant to improving PPT and to transfer- ring PPT research into workplace practice. Successful efforts to address critical issues in many other fields of scientific inquiry have been the result of investing in extramural research centers of excellence. Research centers of excellence allow for interdisciplinary expertise and improved ability to evaluate interventions such as new technologies, while facilitating strong collaborations. Increased intramural research resources and personnel, extramural grants, cooperative agreements, and direct contracts should be balanced to leverage PPT capabilities. Where fea- sible, the PPT Program should take advantage of existing expertise, laboratory infrastructure, and outreach networks, which may be costly to duplicate in the intramural PPT Program. In addition to expanding the resources dedicated to PPT research and development, a strong extramural community provides the opportunity to extend scientific inquiry into the behavioral sciences and other types of expertise that might not be available within the NIOSH PPT Program. PPT centers of excellence should be aligned with one or more of the scientific focus areas of the PPT Program. The centers could be developed to be topic- specific (e.g., heat stress, dermal permeation) or to be sector-specific to explore the unique PPT needs of a particular occupation or set of workers. Several types of centers would be optimal. University-based research centers could establish collaborative networks with other universities and with nonprofit organiza- tions and federal agencies focused on research and development of innovative approaches to PPT. Complementary centers of excellence would be those that are centered in nonprofit organizations, state departments of health or labor, or agen- cies with capabilities and expertise in post-market or field research. These centers, in conjunction with partner organizations and universities, could increase field research, and explore and implement research to practice interventions. Multi- year funding and evaluation are critical to build a strong and ever-improving research base.

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summaRy 5 Recommendation 3: Enhance the Respirator Certification Process The PPT Program should continue to improve the respirator certification process. The program should • Expedite the revision of the respirator certification regulations. As a part of that effort, NIOSH should revise the respirator certification fee schedules so that certification fees paid by respirator manufac- turers fully cover the cost of certification. NIOSH’s research budget for PPT research should not be eroded by the costs of certification. Develop a mechanism for registering the purchase of NIOSH- • certified respirators so that post-marketing notifications and recalls can be accomplished expeditiously and effectively. Expand the audit programs to ensure that results of the product • audit program are methodologically and statistically sound and that the site audit program ensures standardized quality of audits whether performed by NIOSH staff or contractors. Disseminate respirator certification test result data (e.g., breathing • resistance). Respirator certification has been a significant part of the work of the PPT Pro- gram. In FY 2007, almost half (approximately 48 percent) of the PPT Program’s $13.1 million budget was designated for the certification program (in prior years, certification generally constituted about a third of the program’s total budget). In FY 2007, certification occupied about half of the PPT Program’s full-time equiva- lent workforce. The NIOSH respirator certification process is highly respected and provides a major contribution to worker safety. The committee believes that although the enhancements to the certification program recommended above will require additional resources, the dividends that will accrue to workers from improved standards, audits, and information dissemination will make such an investment sustainable and well worth the start-up costs. 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 tests are specified through federal regulations, many of which have not been changed significantly in more than 35 years. The PPT Program through NPPTL has developed a modular approach to updating federal regulations. The committee sees these revisions and additions to the regulatory standards as a major opportunity for the PPT Program to improve respirators through updated tests that address current and evolving technologies. An issue of

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the peRsonal pRotectIve technology pRogRam nIosh at  concern to the committee was the extent of federal resources devoted to the costs of respirator certification, costs that would more appropriately be borne by respirator manufacturers as is done for other types of product certification. Recommendation 4: Increase Research on the Use and Usability of PPT The PPT Program should intensify its research directed at barriers to and facilitators of PPT use by workers. Such research should examine human factors and ergonomics, as well as individual behaviors and organizational behaviors, particularly workplace safety culture. One of the greatest challenges to PPT effectiveness is ensuring that the worker is wearing the equipment and is wearing it correctly. Understanding that comfort is fundamentally a safety issue is a necessary prerequisite to improvement of the materials, design, and engineering of PPT in such a way that critically important human factors are taken into account. Improving usability will require research that focuses on task- and worker-centered design and a more in-depth knowledge of physiologic burdens (often heat stress) resulting from wearing PPT in the work environment. The PPT Program is moving forward in its work with the National Fire Protection Association and other partners in addressing these issues, particu- larly as they relate to physiologic burdens for emergency responders and firefight- ers. However, similar efforts are needed to assess usability issues for the majority of the workforce employed in other occupations. Recommendation 5: Assess PPT Use and Effectiveness in the Workplace Using a Life-Cycle Approach The PPT Program, in collaboration with relevant NIOSH divisions and other partners, should oversee an ongoing surveillance and field testing program to assess PPT use and effectiveness in the workplace. These efforts should emphasize a life-cycle approach by including both pre-market and interval post-market testing of PPT and include data collection on issues ranging from training to decontamination. Enhanced efforts would Assess and critically appraise PPT use and effectiveness across all • types of PPT (e.g., gloves, eye protection, respirators) and across relevant industry sectors and workplace environments; Require random periodic field testing of an adequately sized sample • of PPT to assess effectiveness, usability, and durability with reason- able accuracy and precision; and

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summaRy  Build on existing government and private-sector surveys and sur- • veillance activities that collect PPT-relevant data and facilitate link- ages to other datasets. Improvements in PPT will be driven both by efficacy data generated in the laboratory and effectiveness data gathered with equal scientific rigor in the workplace. Research priorities for PPT should be based on the prevalence and degree of exposure, modified by the strength of the observed association between these attributes of exposure and long- and short-term outcomes of illness and injury. The committee urges the NIOSH PPT Program to assess the effectiveness and use of PPT in the workplace across all phases of the lifetime of the products. This type of evaluation and surveillance construct could involve an array of approaches and methodologies, including pre- and post-market field testing of PPT products, surveys, on-site observations, focus groups and other end user inputs, as well as outcome and impact evaluations and formal cost-benefit analysis. Obtaining input from the end user of PPT products is particularly important. In considering how best to plan and learn from a life-cycle approach to data collection that will involve field testing and ongoing surveillance, it will be impor- tant to keep in mind that the immediate goals will differ with pre- and post-market field testing focused on the effectiveness of a specific product and surveillance focused on an ongoing assessment of PPT use. The committee believes these efforts are a necessary and vital investment for improving PPT and protecting workers from hazardous exposures. By choosing the appropriate methodologies and by building on current data collection efforts, sound investments can be made in obtaining data that are representative of workplace use and useful in improving PPT products and training. CONCLUDING REMARKS The committee urges NIOSH to reexamine its commitment to PPT with a focus that is directly proportional to its importance to the safety and health of millions of workers in the many workplaces where administrative and engineering controls are inadequate, impractical, or simply nonexistent. NIOSH’s Personal Protective Technology Program has made significant strides in improving PPT available to workers, especially respiratory PPT. It is the committee’s hope that the recommendations in this report will provide the neces- sary impetus for the development of a National Personal Protective Technology Program that conducts, coordinates, and provides national oversight of research, standards setting, and certification for all components of PPT and the interface

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the peRsonal pRotectIve technology pRogRam nIosh at  between and among those components. The committee concludes, on the basis of all available evidence, that increasing the protection of workers from hazard- ous workplace exposures through the development and deployment of improved personal protective technologies is not only a critically important and worthwhile goal for workers in the United States and around the world but, with additional resources and thoughtful reorganization, is by no means out of reach.