6
Findings and Recommendations

A COMPREHENSIVE RISK-BASED FRAMEWORK FOR PPT CONFORMITY ASSESSMENT

In considering conformity assessment for personal protective technologies (PPT) used in the workplace, the committee recognized the broad array of PPT products and the wide range of job tasks that people perform while using this equipment. Within the same basic type of PPT, for example gloves, there are wide variations in requirements that must be met to protect workers—protecting construction workers from lacerations when handling sheet metal, healthcare workers handling chemotherapy agents, firefighters facing flames and hot surfaces, and agricultural workers applying pesticides. The lives or health of many members of the U.S. workforce depend on the proper selection and reliable performance of various types of PPT. Reliable conformance of these products to appropriate performance standards is critical.

Current U.S. approaches to occupational PPT are fragmented, often by job sector. Little has been done to classify PPT products based on a comprehensive risk-based framework, which can then be used to identify gaps, prioritize resources, determine and direct conformity assessment efforts, and ensure consistent conformity assessment approaches for comparable products, with the goal of improving worker safety and health. In Chapter 5, the committee began the process toward a comprehensive framework by outlining the guiding principles and a risk-based approach that is needed to categorize PPT, and then outlining options for conformity assessment that could be associated with each category of PPT. Data on the occupational health risks of a specific job due to haz-



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6 Findings and Recommendations A COMPREHENSIVE RISK-BASED FRAMEWORK FOR PPT CONFORMITY ASSESSMENT In considering conformity assessment for personal protective tech- nologies (PPT) used in the workplace, the committee recognized the broad array of PPT products and the wide range of job tasks that people perform while using this equipment. Within the same basic type of PPT, for example gloves, there are wide variations in requirements that must be met to protect workers—protecting construction workers from lacera- tions when handling sheet metal, healthcare workers handling chemothe- rapy agents, firefighters facing flames and hot surfaces, and agricultural workers applying pesticides. The lives or health of many members of the U.S. workforce depend on the proper selection and reliable performance of various types of PPT. Reliable conformance of these products to ap- propriate performance standards is critical. Current U.S. approaches to occupational PPT are fragmented, often by job sector. Little has been done to classify PPT products based on a comprehensive risk-based framework, which can then be used to identify gaps, prioritize resources, determine and direct conformity assessment efforts, and ensure consistent conformity assessment approaches for comparable products, with the goal of improving worker safety and health. In Chapter 5, the committee began the process toward a compre- hensive framework by outlining the guiding principles and a risk-based approach that is needed to categorize PPT, and then outlining options for conformity assessment that could be associated with each category of PPT. Data on the occupational health risks of a specific job due to haz- 115

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116 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES ardous exposures in the workplace can be estimated based on knowledge about the exposure; this information can be used to categorize PPT. Throughout the report the committee documents a wide range of ap- proaches to PPT conformity assessment and the varied nature of gov- ernment agency involvement in these processes. The role of federal agencies ranged from an all-encompassing role in each phase of confor- mity assessment (e.g., respirators) to more specific roles such as standar- dized labeling (e.g., Noise Reduction Rating labels for hearing protection devices). Other roles for federal agencies include accrediting testing la- boratories or specifying accreditation organizations. For some products, the government agency acts as the certifying organization. A unique government role in a voluntary third-party conformity assessment pro- gram is evidenced by the Bulletproof Vest Partnership Program, through which the Department of Justice provides a financial incentive through matching grants to law enforcement agencies to purchase compliant body armor. Government agencies also play key roles in the research needed to support standards development and conformity assessment processes, in- cluding the development and assessment of potential test methods. Health surveillance also can be facilitated through the work of federal, state, or local agencies. The committee emphasizes that consistency in the level of rigor re- quired for conformity assessment of PPT products used for tasks with comparable risks is a priority. Therefore, the first step is to establish a framework that will categorize similar products based on the level of risk (low, medium, or high) to the health or safety of the worker that could result from failure of the product (equivalent to not using PPT), while also considering feasibility, cost, and other pragmatic factors described in Chapter 5 (e.g., cost of conformance, impediments to innovation, competition, comfort, durability, globalization, risk to manufacturer’s reputation due to poor product quality and/or product failure). Conformi- ty assessment requirements would be detailed for each category of prod- ucts in the framework. Efforts will be needed to identify the gaps and inconsistencies in current approaches for specific types of PPT, particu- larly for those in the medium- and high-risk categories. Regulations mandating that PPT products used in the workplace adhere to conformity assessment and certification processes will be critical to ensuring that more rigorous product testing and audit requirements are met. An in- creased role for third-party testing and conformity assessment is recom- mended for many types of PPT because of the value of independent assessments in increasing the rigor of the process. As noted throughout

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117 FINDINGS AND RECOMMENDATIONS this report, third-party testing and declaration of conformity assessment can and are being done largely by third-party private-sector organiza- tions, which is consistent with the approach of the National Technology Transfer and Advancement Act (Public Law 104-113). The recommendations provided in this chapter are focused on the role of the National Institute for Occupational Safety and Health (NIOSH), and specifically the National Personal Protective Technology Laboratory (NPPTL), as it is the only federal organization that is focused solely on PPT and therefore has a leadership role in addressing PPT is- sues. However, the actions that are recommended require coordination and cooperation with multiple federal agencies, private-sector corporations and organizations, workers, and other stakeholders. Box 6-1 summarizes the findings of the committee regarding non-respirator conformity assess- ment efforts. BOX 6-1 Findings on Conformity Assessment Range of Conformity Assessment Efforts • Currently, conformity assessment efforts for non-respirator personal pro- tective technologies (PPT) products involve a wide range of processes, some of which rely on manufacturers’ attestation that the product meets the relevant voluntary consensus standards and others that require third- party independent testing and/or certifying that the product’s performance meets the required criteria. Several approaches to third-party conformity assessment processes using either mandatory or voluntary consensus standards appear to be successful in assessing the effectiveness of PPT. • The Food and Drug Administration and European Union use tiered, risk- based approaches to conformity assessment of PPT; opportunities exist to enhance these processes. • Several mechanisms exist for accrediting private-sector laboratories and certifying organizations to conduct testing of PPT products. The accredita- tion process based on American National Standards Institute/International Organization for Standardization requirements is commonly used for ac- crediting these organizations. • Product specifications and procurement practices that reference standards and conformity assessment mechanisms provide the basis for client- and customer-driven systems. Product Standards • Product standards that require validated test methods and include ade- quate pass/fail requirements are the basis for rigorous and thorough confor- mity assessment processes. End-user input is critical to the development of valid and useful standards. continued

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118 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES BOX 6-1 CONTINUED Role of Government Agencies • Involvement of federal government agencies in the conformity assess- ment process for PPT has been shown to be beneficial for worker health and safety, as evidenced by certification of respirators and body armor. The role of federal agencies varies considerably among conformity as- sessment processes. Although there are models of collaboration among government agencies (e.g., National Institute for Occupational Safety and Health, Environmental Protection Agency, and Department of Homeland Security), opportunities to improve these relationships exist. • Government acquisition of products, structures, and services can demon- strate leadership and better serve the public by specifying PPT that meet performance standards through procurement procedures. Recommendation 1: Develop and Implement Risk-Based Conformity Assessment Processes for Non-Respirator PPT The National Institute for Occupational Safety and Health (NIOSH) should work with other relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop, implement, and support conformity assessment processes for non-respirator PPT. These conformity assessment processes should be commensurate with the level of risk of in- jury, illness, or death that could result from failure of the PPT to protect the user from workplace hazards. NIOSH’s National Personal Protective Technology Labora- tory (NPPTL) should serve in a leadership role and convene oth- er relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop and im- plement a comprehensive, tiered risk-based framework for the classification and conformity assessment of PPT products for specific applications. This framework should be based on the de- gree of risk to the safety and health of the user and other factors affecting the feasibility of implementing the proposed conformity assessment processes. To develop this framework and implement the conformity assessment processes, the committee recommends that • Components of the tiered PPT conformity assessment framework include the following categories and actions:

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119 FINDINGS AND RECOMMENDATIONS Low risk—manufacturer’s attestation to meet relevant o standards, o Medium risk—third-party testing and certification, and o High risk—third-party testing and certification with government involvement to provide oversight and to as- sist in enforcement; • Current processes and innovative models (e.g., probabilistic models) should be explored, where adequate data exist, for assessing the level of risk and incorporating other feasibility factors into categorizing PPT; • NIOSH NPPTL should work with other relevant federal agencies, manufacturers, organizations, and end users to identify current gaps and priorities in conformity assessment for medium- and high-risk PPT use, and to subsequently en- gage in developing and implementing the appropriate con- formity assessment processes; • NPPTL and other government agencies should have the ap- propriate level of engagement in the conformity assessment processes for non-respirator PPT depending on the risk lev- el; and • Government contracts should specify that PPT used in work to fulfill those contracts must meet the requisite level of con- formity assessment based on the comprehensive risk-based PPT framework. RESEARCH, SURVEILLANCE, AND COMMUNICATION As outlined in its vision statement, NPPTL aims to be the leading provider of quality and timely PPT research, training, and evaluation. NPPTL is already substantively involved in many aspects of conformity assessment for non-respirator PPT, particularly through active involve- ment in voluntary standards development and development of test me- thods. Continued efforts in standards setting would be enhanced with NPPTL working with stakeholder organizations and other government agencies to encourage and promote end-user involvement in the devel- opment of voluntary consensus standards. As a research agency, NPPTL is well suited to furthering its ongoing efforts to develop test methods and conduct research that contributes to the development of voluntary consensus standards and other conformity

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120 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES assessment efforts for improving PPT. In particular, the committee em- phasizes protective ensembles and believes that NPPTL should focus efforts on PPT interface and related issues that are important in ensuring the effective use of multiple types of PPT or integrated ensembles. A new area for exploration could be the development and evaluation of the effectiveness of integrated ensembles for healthcare worker infection control precautions. Increased post-marketing testing, evaluation, and surveillance are key factors in enhancing PPT products for worker use. The limited avail- ability of data on product effectiveness across the life cycle of PPT, and in particular on PPT use in the workplace (including use of PPT in emer- gency conditions), is currently hindering improvements in PPT and PPT conformity assessment processes. A surveillance network that draws on and expands current surveillance systems already in place (see Chapter 2) could provide information needed to identify workplace tasks where inju- ries, illnesses, or deaths are occurring because of noncompliant and/or poorly manufactured PPT, inadequately or incorrectly labeled PPT, the PPT not being provided by the employer, and/or any end-user perfor- mance issues associated with PPT (e.g., the incorrect use of PPT due to inadequate or improper training that could shed light on PPT training needs). This type of information will also support the development of an effective PPT recall system to prevent additional worker injury or illness when PPT performance problems are identified. The fragmented nature of current PPT conformity assessment has re- sulted in multiple and diverse sources of information that employers, workers, and others need to consult in order to identify certified equip- ment or find independent information on non-respirator PPT. NPPTL currently administers its Certified Equipment List, which details the res- pirators and respirator components that meet certification criteria. This has been found to be valuable to end users and administrators responsible for selecting and providing respirator protection for workers. Similarly, the Responder Knowledge Base is a comprehensive resource for select- ing emergency responder PPT. A single reputable source of information on all certified PPT is needed to provide end users, employers, and pur- chasers the ability to make informed PPT selections for a wide range of jobs and job tasks. This listing (available through a website and/or other sources) should include data on the product, relevant standards, the certi- fication mark, date of certification, training requirements for safe use, and any product recalls and safety alerts about PPT. This expanded list of certified equipment could link to lists of certified equipment from accre-

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121 FINDINGS AND RECOMMENDATIONS dited third-party certifying organizations. Integrating information into this resource from the proposed surveillance system could provide addi- tional information on PPT products. Box 6-2 summarizes the commit- tee’s findings on research, surveillance, and communication issues. BOX 6-2 Findings on Research, Surveillance, and Communication NPPTL Expertise • The National Personal Protective Technology Laboratory (NPPTL) has unique expertise in personal protective technologies (PPT). There are opportunities for NPPTL to play an expanded role in standards setting and conformity assessment for non-respirator PPT, including research, surveillance, and communication. PPT for Healthcare Workers in an Influenza Pandemic • The unique strengths and expertise of the NPPTL, part of the National Institute for Occupational Safety and Health, could be better used to en- hance PPT for healthcare workers through increased collaborations with the Food and Drug Administration. Limits on Current Data and Need for Enhanced Surveillance and Post- Marketing Evaluation Data • Assessing the impact of conformity assessment processes for specific PPT on worker safety and health is a challenge because of limited data collection systems and the difficulty in collecting data, especially in oc- cupations where: (1) multiple safety measures are implemented; (2) ex- posures are intermittent or variable; or (3) risks are poorly characterized. Surveillance systems and follow-up data on field use of PPT are needed to determine where improvements are needed in standards and confor- mity assessment processes. Communication of PPT Conformity Assessment • Currently there is no comprehensive repository or database with govern- ment oversight that provides information to end users on certified non- respirator PPT. This information is needed so that end users can select PPT to meet the required standards for a specific work task.

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122 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Recommendation 2: Enhance Research, Standards Development, and Communication NIOSH NPPTL should continue and expand its role in PPT conformity assessment. Specifically, NPPTL should • Continue its involvement in standards-setting processes and committees and facilitate end-user participation in voluntary consensus performance-based standards; • Expand research efforts on non-respirator PPT (based on risk assessment and opportunities) to include further efforts to establish standards and to develop test methods; • Develop and maintain an online resource (available through a website and other sources) that provides access to listings of all non-respirator PPT products that meet third-party conformity assessment requirements; • Expand its role and become the primary clearinghouse for reliable information on non-respirator PPT; • Fund research and support standards development necessary to test and certify protective ensembles, develop criteria for standardized interfaces, and flag non-conforming ensemble components; and • Expand its efforts in influenza pandemic-related research and conformity assessment for infection control ensembles. Recommendation 3: Establish a PPT and Occupational Safety and Health Surveillance System NIOSH should work with the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA), Oc- cupational Safety and Health Administration (OSHA), third- party certifying organizations, and other relevant organizations to establish an electronic PPT and Occupational Safety and Health Surveillance System that includes data on PPT product effectiveness in the workplace. This system would involve the col- lection and analysis of data across the life cycle of PPT products (from design and production to worker use and maintenance) on the use of PPT, the failure of PPT, and adverse outcomes (injury, illness, fatality) that occur while wearing PPT in the workplace,

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123 FINDINGS AND RECOMMENDATIONS including information on the performance standards assessed and adherence to labeling requirements. These efforts should collect and analyze data on PPT product effectiveness in the field by collaborating with existing surveillance programs and ex- panding where needed to incorporate data collection on PPT use across industries including product recall information. The sur- veillance system should link to the expanded Certified Equip- ment List. Potential sources of collaboration include • Other NIOSH surveillance and data collection systems, in- cluding the Fatality Assessment and Control Evaluation pro- gram, health hazard evaluations, and the Sentinel Event Notification System for Occupational Risk (SENSOR); • CPSC’s recall database, unsafe product reporting system, and the National Electronic Injury Surveillance System (NEISS); • The FDA’s surveillance and adverse event reporting databas- es, such as the Medical Product Safety Network (MedSun), the FDA Safety Information and Adverse Event Reporting Pro- gram (MedWatch), and the Manufacturer and User Facility Device Experience (MAUDE) database; and • OSHA’s injury and fatality investigations and surveys to col- lect information about injuries or illnesses potentially due to the failure of PPT.

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