3
Current PPT Conformity Assessment Processes

The employer shall select and provide an appropriate respirator based on the respiratory hazard(s) to which the worker is exposed and workplace and user factors that affect respirator performance and reliability. The employer shall select a NIOSH-certified respirator. The respirator shall be used in compliance with the conditions of its certification.

29 CFR §1910.134(d)

All compliant product that are labeled as being compliant with this standard shall meet or exceed all applicable requirements specified in this standard and shall be certified.

NFPA 1971, Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting

Because workers face a wide range of hazards in the workplace, the types of personal protective technologies (PPT) used to prevent or reduce exposures, injuries, or fatalities differ widely among occupations. Requirements for thermal and respiratory protection needed by firefighters differ from fall protection needed on high-rise construction sites, which differ from the dermal and respiratory protection needed by agricultural pesticide operators.

The committee was charged with examining a variety of approaches used to conduct conformity assessment efforts. This chapter provides overviews of several approaches to conformity assessment, specifically those for respirators, healthcare worker PPT, firefighter and emergency responder PPT, ballistic-resistant body armor, hearing protection devices, personal flotation devices, and PPT for pesticide operators. For each, the process is described briefly, and the committee’s assessment is provided on the strengths and weaknesses of these approaches particularly as they



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3 Current PPT Conformity Assessment Processes The employer shall select and provide an appropriate respirator based on the respiratory hazard(s) to which the worker is exposed and workplace and user factors that affect respirator performance and reliability. The employer shall select a NIOSH-certified respira- tor. The respirator shall be used in compliance with the conditions of its certification. 29 CFR §1910.134(d) All compliant product that are labeled as being compliant with this standard shall meet or exceed all applicable requirements specified in this standard and shall be certified. NFPA 1971, Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting Because workers face a wide range of hazards in the workplace, the types of personal protective technologies (PPT) used to prevent or reduce exposures, injuries, or fatalities differ widely among occupations. Re- quirements for thermal and respiratory protection needed by firefighters differ from fall protection needed on high-rise construction sites, which differ from the dermal and respiratory protection needed by agricultural pesticide operators. The committee was charged with examining a variety of approaches used to conduct conformity assessment efforts. This chapter provides overviews of several approaches to conformity assessment, specifically those for respirators, healthcare worker PPT, firefighter and emergency responder PPT, ballistic-resistant body armor, hearing protection devices, personal flotation devices, and PPT for pesticide operators. For each, the process is described briefly, and the committee’s assessment is provided on the strengths and weaknesses of these approaches particularly as they 55

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56 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES relate to conformity assessment for non-respirator PPT. The chapter also briefly discusses the conformity assessment approach used in the Euro- pean Union for PPT products. These examples provide the details for the steps in the conformity assessment process described in Chapter 2 and throughout the remainder of the report. RESPIRATOR CERTIFICATION The National Institute for Occupational Safety and Health (NIOSH) is the principal governmental agency with responsibility for testing and certifying respirators. Certification testing and related research is con- ducted at NIOSH’s National Personal Protective Technology Laboratory (NPPTL) in Pittsburgh, Pennsylvania. NIOSH’s work in post-marketing testing and evaluation efforts, including product and manufacturing au- dits, is also conducted by NPPTL. Testing and certification requirements are detailed in federal regulations (42 CFR Part 84). The U.S. federal government has been involved in evaluating respi- ratory protection since the early 1900s. With the Organic Act of 1910 (Public Law 61-179), the U.S. Bureau of Mines (USBM) was founded to deal with a wave of catastrophic mine disasters. Early goals of the USBM were aimed at determining whether fatalities from coal mine ex- plosions were caused by injury or suffocation. The mission of USBM expanded over the years to testing and certifying respirators. The USBM was solely responsible for testing and certifying respirators until NIOSH was established in 1971 with a broader health and safety focus on all oc- cupations. In 2001, NIOSH received a congressional mandate to expand occupational safety and health research. As part of this direction, NIOSH established NPPTL as a new laboratory focused on PPT and responsible for respirator certification. Standards Standards for respirator testing and certification are set in federal regulations as part of the Code of Federal Regulations (CFR). In 1972, NIOSH and USBM jointly published updated respirator certification reg- ulations as 30 CFR Part 11. NIOSH undertook primary responsibility for performance testing of respirators in 1973. Respirator responsibilities for USBM, and subsequently the Mine Safety and Health Administration

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57 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES (MSHA), focused on products and issues specific to mining applications. In the early 1980s, NIOSH, MSHA, and the respirator stakeholder com- munity revised the regulations to meet changing needs in the workplace. The resulting new regulations, 42 CFR Part 84, were first published for public comment in August 1987 and finalized in 1995. Efforts to change the regulations involve a complex and lengthy federal rule-making process often taking at least 2 to 3 years and often much longer, from development of the performance criteria and background documents, through the comment period and revisions, to enactment of the Final Rule (IOM and NRC, 2008). NPPTL is currently revising the regulations by using a modular approach that addresses changes to specific sections, with the goal of completing two regulatory modules per year (IOM and NRC, 2008). Conformity Assessment The conformity assessment process for respirators is a third-party certification effort, with all phases conducted by NIOSH. Respirator manufacturers register with NIOSH to obtain a manufacturer’s code, which allows for quality assurance evaluations. Samples are sent by the manufacturers to NPPTL and undergo a series of test procedures that vary depending on the category of respirator. Tests include evaluations of filter efficiency, determination of exhalation valve leakage, and evalu- ations of breathing resistance (NIOSH, 2010a). The goal for turnaround time for testing is no more than 90 days (IOM and NRC, 2008). NPPTL is currently undergoing International Organization for Standardization (ISO) accreditation as a testing laboratory. Manufacturers may also send prototypes of upcoming products and receive results on how they per- formed in testing. Respirators and respirator components that meet the testing criteria are listed on the NIOSH Certified Equipment List, and manufacturers are given approval to affix the NIOSH certified label to their products. NIOSH conducts site and product audits, although program resources for these purposes are limited (IOM and NRC, 2008). Each manufactur- ing site undergoes a site audit at least every 2 years. Additionally, NIOSH has a product auditing program where a limited number of respi- rators are purchased commercially and then tested. Self-contained, self- rescuer respirators used in mining environments are routinely pulled from the workplace and tested by NIOSH. The agency also tests certain

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58 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES respirators that are alleged to be defective by wearers or others (e.g., a recent study examined N95 respirators submitted by the state of Califor- nia [NIOSH, 2010b]), and runs a Certified Product Investigation Process. Once a respirator is certified, the manufacturer is not required to resub- mit the device for further testing unless modifications are made. Manu- facturers are charged a fee for testing and certification; however, fees are based on 1972 fee schedules and do not reflect NIOSH’s total costs for performing this work (IOM and NRC, 2008). Requirements and Incentives The Occupational Safety and Health Administration (OSHA) re- quires that all respirators used in workplaces be NIOSH certified. OSHA also requires a complete respiratory protection program at the worksite, including fit testing of respirators where relevant (29 CFR §1910.134). OSHA’s penalties for infractions—in addition to the demand by employ- ers, workers, and unions for certified respirators—work to ensure that the products purchased for employee use are NIOSH certified. Responsible manufacturers also make efforts to ensure that their products meet the testing criteria and are certified. Although funds for post-market evaluations are limited, NIOSH has recently identified several respirators for which the manufacturer made fraudulent claims of NIOSH certification (NIOSH, 2010c). NIOSH NPPTL can revoke certification and, to the extent possible, actively pursues these cases to make sure that the labeling is changed or that the devices are removed from the marketplace. This action is limited to NIOSH approval holders. As noted in the 2008 Institute of Medicine (IOM) and National Research Council (NRC) report that assessed the NIOSH PPT Program, post-marketing evaluation and efforts to dissemi- nate revocation notifications need to be expanded. Committee Comments NPPTL conducts rigorous testing of respirators and is actively in- volved in updates to respirator standards. The respirator conformity as- sessment process (summarized in Table 3-1) involves an active role for NPPTL in all phases of the process, including post-marketing testing and

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59 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES TABLE 3-1 Overview of the Conformity Assessment Process for Respirators Standards Government regulations (42 CFR Part 84) Testing Third party: NIOSH Attestation of conformity assessment Third party: NIOSH certification Laboratory accreditation ISO 17025 accreditation of NPPTL in progress Surveillance and post-market testing and NIOSH NPPTL conducts manufacturing evaluation and product audits, respirator equipment investigations, the Long-Term Field Eval- uation Program for mine escape respira- tors, and the Firefighter Fatality Investiga- tion and Prevention Program Incentives/enforcement OSHA requires NIOSH-certified respira- tors in the workplace evaluation of respirators (albeit with limited funds for this purpose), with extensive stakeholder input into all phases of the conformity assessment efforts (IOM and NRC, 2008). In 2007, 81 percent of applications for air-purifying and air-supplied respirator certification were processed within 90 days 1 (IOM and NRC, 2008). However, this federally intensive process presents challenges. NIOSH testing standards are slow to change due to tedious legal requirements, and as a result, the overall process can tend to stifle innovation. Furthermore, this extensive certification process is resource intensive. Given that the costs are not covered by the fees charged to manufacturers, it is unlikely that future NIOSH budgets will have enough funding to extend the current testing and certification model used for respirators to other types of PPT (e.g., protective clothing). Re- garding the shortfall in respirator certification fees, a recent IOM/NRC committee concluded, “NIOSH should revise the respirator certification fee schedules so that certification fees paid by respirator manufacturers fully cover the cost of certification. NIOSH’s research budget for PPT research should not be eroded by the costs of certification” (IOM and NRC, 2008, p. 15). 1 The committee did not have comparison data on the average length of time required for other (nonrespirator) certification processes.

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60 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES HEALTHCARE WORKER PPT The Food and Drug Administration (FDA) has federal regulatory au- thority to ensure the safety and effectiveness of medications and medical devices brought to market in the United States. PPT for healthcare work- ers are considered medical devices and are subject to FDA evaluation and oversight. Standards The standards for healthcare PPT include those issued by ASTM In- ternational, the American National Standards Institute (ANSI), the Asso- ciation for the Advancement of Medical Instrumentation, and others. The FDA recognizes voluntary consensus standards and incorporates them into its guidance documents for manufacturers of medical devices. The standards are not codified in federal regulations. Federal regulations for healthcare PPT provide a broad description of the product and identify the medical device class (e.g., 21 CFR §880.6265, examination glove). Conformity Assessment The FDA categorizes medical devices into three classes associated with low, intermediate, and high risk to patients or users of the device; specific approval processes are defined for each class (FDA, 2010). Class I devices are considered low risk. This category includes items such as ton- gue blades, shoe covers, caps, and patient examination and surgery gloves (Box 3-1). Class II devices are deemed intermediate risk. PPT in this category include surgical gowns, surgical masks, and respirators. Class III devices are deemed high risk and include those devices that are “life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury” (21 CFR §860.3). Implantable cardiac pacemakers, breast implants, and cochlear implants are among these devices. The class to which a medical device is assigned determines the process by which the FDA evaluates safety and effectiveness. All medical

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61 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES BOX 3-1 Medical Gloves Medical gloves, including those used for surgery and medical examination, are Class I medical devices, but manufacturers are required to submit a 510(k) ap- plication prior to bringing product to market. Manufacturers must be in com- pliance with general controls and Good Manufacturing Practices for medical glove manufacture. Broadly, this includes quality management and organiza- tion, device design, production and process controls, packaging and labeling controls, device evaluation, distribution, complaint handling, servicing, and records. FDA requires that manufacturers of surgeon and medical examination gloves demonstrate substantial equivalence to gloves already approved for market. Voluntary consensus standards are recognized by the FDA, and manufacturer compliance with the recognized standards serves to demonstrate substantial equivalence. This includes, for example, ASTM standards for detection of holes and tests for residual powder (FDA, 2008). Recommendations for gloves with special attributes are also included in the FDA guidance. For chemotherapy gloves, for example, in addition to conformance with the recognized standards (or equivalent) for medical gloves, the FDA application stipulates inclusion of: “(1) the product labeling that specifies the chemical(s) that the glove provides protection against; (2) the results of a controlled scientific study to substantiate the claim; (3) a comprehensive description of the test method used; (4) the complete test protocol; (5) an analysis of test results; (6) a discussion as appro- priate and conclusions” (FDA, 2008). Third-party testing is not required. devices are subject to a range of general controls, which include prede- fined Good Manufacturing Practices. This umbrella Quality System Regulation, defined in 21 CFR Part 820, provides a framework that all device manufacturers must follow with regard to device design, produc- tion and packaging controls, evaluation, servicing, recordkeeping, and other factors. These controls are deemed sufficient to ensure the safety and effectiveness of Class I devices, so these devices can be registered and listed without further rigorous premarket evaluation. Class II devic- es, because they are intermediate risk, are expected to meet or exceed defined controls or standards in addition to adherence to general controls. Class II devices are most often approved by demonstration of “sub- stantial equivalence” to a previously approved product already on the market, known as the “predicate.” This process is known as approval via a 510(k) application, as defined by Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Public Law 75-717). If a device differs substan- tially from previously marketed products, particularly in a way that

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62 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES brings its safety and effectiveness into question, then a full Premarket Approval (PMA) process is required. The reporting requirements of a PMA are more rigorous and far more substantive than that required by the 510(k) application and subsequently increase processing time and cost. The FDA identifies the devices that are determined to be high risk and therefore require the PMA process, including most Class III devices. PPT used by healthcare workers are currently categorized as Class I and II devices (Table 3-2); no PPT are categorized Class III devices. Some Class I devices, such as medical examination gloves, are also required to comply with the 510(k) process. The FDA also oversees post-market evaluation, surveillance, and enforcement processes, including both voluntary and mandatory adverse event reporting systems that rely on manufacturers, hospitals, long-term care facilities, and individual practitioners and patients to report device- related adverse outcomes (FDA Medical Product Safety Network [MedSun] and FDA Safety Information and Adverse Event Reporting Program [MedWatch]). The FDA manages a publicly available database of ad- verse event reports, the Manufacturer and User Facility Device Expe- rience Database (MAUDE). The FDA augments this passive surveillance for some devices with post-approval review of literature or clinical trials, establishment and maintenance of mandated registries, and routine and targeted field inspections. When problems are identified, the FDA may conduct a more intensive investigation. TABLE 3-2 FDA Classification of PPT-Related Equipment Risk to Patient or Healthcare PPT and Related Devicesa Class Device Wearer Requirements • I Low General standards Surgeons’ gloves for good manufacturing (510[k] required) processes; most Class I • Examination gloves devices are exempt from (510[k] required) 510(k) submissions • Other surgical ap- parel (isolation gowns, shoe covers, caps, hoods, operat- ing room shoes) (510[k] exempt)

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63 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES TABLE 3-2 Continued Risk to Patient or Healthcare PPT and Related Devicesa Class Device Wearer Requirements • Surgical gowns II Intermediate 510(k) submission • Surgical masks • Surgical respirators III High Subject to pre-market None approvals; must submit clinical evidence of safety and effectiveness NOTE: The FDA uses the terms surgical gowns, isolation gowns, surgical masks, and surgical respirators and defines each in guidance documents. a Protective eyewear used as PPT is not regulated by the FDA as a medical device. SOURCE: IOM (2008). Requirements and Incentives For healthcare PPT, the FDA has the authority to promulgate public health advisories and safety alerts, issue warning letters to manufactur- ers, recall or seize products, suspend or revoke device approval, and recommend criminal prosecution. FDA regulations are focused on the manufacturer. OSHA regulations address whether employers are providing appro- priate PPT and training. When the potential exists for healthcare workers to be exposed to blood-borne pathogens, OSHA requires use of PPT that “does not permit blood or other potentially infectious materials to pass through to or reach the employee’s work clothes, street clothes, under- garments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used” (29 CFR §1910.1030). OSHA does not specifi- cally require that PPT used by healthcare workers be FDA approved or cleared, but OSHA does require many of the same standards that form the basis for FDA clearance and approval decisions. In addition to OSHA regulations, a further incentive to healthcare fa- cilities seeking accreditation by the Joint Commission are the Joint Commission’s standards regarding infection control, which include ex- pectations that respirator fit testing is conducted and updated.

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64 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Committee Comments The FDA conformity assessment process used for healthcare PPT (summarized in Table 3-3) is based on conformity to a “predicate,” al- ready approved for market. Voluntary consensus standards, recognized by the FDA, are incorporated into guideline documents to assist manu- facturers to demonstrate substantial equivalence to the predicate. Be- cause these standards are not codified in federal regulations, they can potentially be amended more rapidly than federal regulations. The stan- dards currently recognized by the FDA for PPT establish the required physical attributes but not necessarily its performance in the healthcare setting. The committee emphasizes the need for conformity assessment processes that examine performance of the PPT against workplace hazards and exposures. Increased input from healthcare workers on standards de- velopment committees is important in improving these processes. The FDA’s conformity assessment processes for PPT products are dependent on testing data submitted by the manufacturers and do not re- quire third-party testing (except for respirators). For some types of PPT used by healthcare workers for which failure of the PPT product could result in injury or illness of workers, more rigorous conformity assess- ment requirements are needed. Recent studies by the Government Ac- countability Office (GAO) report that the FDA medical device approval system is facing large volumes of applications for increasingly complex devices from U.S. and international manufacturers. The GAO reports noted concerns about the lack of adequate resources at the FDA to ad- dress the demand, a reduced emphasis on the PMA process, and fewer inspections of manufacturing facilities (GAO, 2008, 2009). The 510(k) process is currently being reviewed by the Institute of Medicine (IOM, 2010). TABLE 3-3 Overview of the Conformity Assessment Process for Healthcare Worker PPT (Non-Respirator) Standards Voluntary consensus standards incor- porated into FDA guidance documents Testing First party: Manufacturers submit re- quired information to FDA Attestation of conformity assessment Third party: FDA reviews product data for Class II and Class III products Laboratory accreditation Not applicable

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65 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES TABLE 3-3 Continued Surveillance and post-market testing and FDA evaluations Incentives/enforcement FDA and OSHA regulations, Joint Commission standards The FDA’s medical device approval process relies on determining equivalence to predicate devices. The requirements for FDA clearance or approval are determined by an initial categorization of the type of device as to the level of risk that could be posed to the patient or user. Products used in work tasks with widely differing potential risk may be classified in the same risk category. For example, as noted in Box 3-1, chemothe- rapy gloves are a subcategory of patient examination gloves, both cate- gorized as Class I products, even though failure of a chemotherapy glove likely presents much more risk to the wearer given skin exposure to toxic and often carcinogenic drugs. The FDA is currently requiring additional data for clearance of chemotherapy gloves even though they are still ca- tegorized as a Class I device. The FDA’s regulatory authority for enforcing compliance is a strength of the medical device approval process, although a concern is whether resources are adequate to conduct site inspections and surveil- lance efforts. The requirements that manufacturers meet Quality System Management regulations specified by the FDA could be bolstered by specifying that relevant ANSI/ISO standards (e.g., ISO 9000 standards for quality management systems) need to be met. FIREFIGHTER AND EMERGENCY RESPONDER PPT Conformity assessment for most firefighter and emergency responder PPT (excluding respirators) follows a voluntary third-party certification process. The National Fire Protection Association (NFPA) is recognized as the primary national source of standards for firefighter and emergency responder protective clothing and equipment. NFPA committees have developed standards for a wide variety of PPT, including standards for protective ensembles for structural, proximity, and wild land firefighting as well as standards for garments for protection of industrial personnel against flash fire. Additionally, NFPA standards cover a broad range of emergency response applications beyond firefighting applications, in-

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78 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES uct was “Inspected and tested in accordance with U.S. Coast Guard regu- lations” and stating the manufacturer’s or distributor’s name and address as well as the lot number (46 CFR Subpart 160.002). UL is also tasked with ensuring that manufacturers maintain quality control programs as detailed in USCG regulations. The extent of manu- facturing site inspections is determined in a product sampling plan based on the number of devices produced and the nature of the quality controls used (USCG, 2010a). As part of the post-marketing testing and evalua- tion efforts, manufacturers are required to send samples of wearable recrea- tional PFDs to UL testing facilities once a year for inspection and testing. Requirements and Incentives Incentives for PFD conformity assessment include demand for certi- fied products from workers, employers, passengers, recreational boaters, and other individuals involved in water activities. In the United States, commercial passenger watercraft and recreational watercraft are required to have USCG-approved PFDs for each passenger on board (with some exceptions). USCG has the authority to enforce requirements for use of PFDs within its jurisdiction. Committee Comments The conformity assessment processes for PFDs are summarized in Table 3-7. As noted above, codifying standards in federal regulations has pros and cons. The regulations provide USCG with enforcement authori- ty, but changes to the standards require more lengthy processes. For ex- ample, standards for inflatable PFDs were specified for adults, but at the time these standards were developed it was unknown whether children or youth could cope with the backup inflation needed in case of automatic inflation system failure. Experience and study have shown that children at least 12 years and older can handle inflatable PFDs (Young et al., 2009), and the need for more comfortable PFDs makes it desirable for the USCG to approve inflatable PFDs for this group. Regarding probabil- istic models for risk-based standards (Box 3-2), the development of these models requires extensive resources and should likely be considered only for PPT where failure of the products could result in death or serious injury.

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79 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES TABLE 3-7 Overview of the Conformity Assessment Process for Personal Flotation Devices Standards USCG and voluntary consensus standards Testing First party, with third-party oversight Attestation of conformity as- Third party sessment Laboratory accreditation Approved by USCG Surveillance and post-market Conducted by third-party certifying organization testing and evaluation Incentives/enforcement USCG penalties NOTE: USCG = U.S. Coast Guard. Longstanding third-party testing and certification processes have been refined by the USCG. The committee did not examine the implica- tions of having only one testing and certifying organization, but ac- knowledges that the system has been working for many years. PROTECTIVE CLOTHING FOR PESTICIDE OPERATORS In the United States, protective clothing required for pesticide opera- tors is under the jurisdiction of the EPA. The requirements are mandated through CFR 40 with details provided as part of 40 CFR Part 170, Work- er Protection Standard, and 40 CFR Part 171, Certification of Pesticide Applicators. A conformity assessment process does not currently exist, however, for assessing the protective performance of these garments. Therefore, inclusion of performance-based criteria is being proposed as part of the two CFR sections that are currently undergoing revision. Standards In 2009, ASTM Standard F2669, Standard Performance Specifica- tion for Protective Clothing Worn by Operators Applying Pesticides, was approved as a performance specification for protective clothing for pesti- cide operators. An equivalent ISO standard draft is now under review.

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80 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES The technical requirements of the two standards are similar, with input provided by individuals representing relevant federal agencies, the crop protection industry, garment manufacturers, researchers, and users. The performance specification standards categorize the protective clothing into low, medium, and high levels of protection. Testing and other re- quirements in ASTM F2669 reflect the level of protection provided by the garment, with more stringent requirements for higher levels of protection. Conformity Assessment A risk-based conformity assessment process based on use of the three levels of protection specified in ASTM F2669 is being explored by the EPA, NPPTL, and other agencies and organizations. An approach being considered is the use of potential risk to the operator (calculated as part of the risk assessment for pesticide registration) being the basis for determining protective clothing requirements. The conformity assessment details are still being developed, with a proposal to require first-party dec- laration of conformity for Class 1 products (low potential risk) and third- party certification required for Classes 2 and 3 (medium and high poten- tial risks). Committee Comments The proposed process provides an opportunity for EPA and NPPTL to work together to address the health and safety of pesticide operators using a performance-based conformity assessment process. EPA, with jurisdiction over pesticide registration and enforcement of the regula- tions, could draw on the PPT expertise provided by NPPTL. OTHER PPT In the United States, the certification of PPT other than respirators is not federally mandated in OSHA or MSHA regulations. If a manufactur- er chooses to certify the performance of its PPT products (other than res- pirators), third-party certifying organizations can test the product to de- termine if specific ASTM, ANSI, or other standards have been met. For example, Safety Equipment Institute (SEI), UL, and CSA International are private-sector organizations that administer third-party certification

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81 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES programs by testing and certifying a broad range of safety and protec- tive products used occupationally and recreationally. Third-party or- ganizations generally undergo accreditation processes to affirm that the specific certification program meets ISO Guide 65 and other re- quired standards. As noted in Table 3-8, voluntary third-party certifi- cation programs are available for a number of types of PPT. Some cer- tifying organizations have the testing conducted by a set of accredited third-party laboratories, while others use internal testing facilities and capacity. Committee Comments Although OSHA regulations specify voluntary consensus standards that need to be met for non-respirator PPT, third-party testing or certifi- cation of these products (including head, foot, and fall protection) is not mandated. Where the use of these products is required because of high-risk worksites, third-party testing and, in many cases, third-party certification could be a mechanism for reducing the risk to workers and enhancing the certainty that the PPT products meet performance requirements. TABLE 3-8 Examples of Voluntary Consensus Standards and Certifying Organizations Examples of Relevant Examples of Certifying Standard(s)a Organizations Head protection, hard hats ANSI Z89.1-2003, 1997, SEI, UL, CSA 1986b International Protective footwear ASTM F2412-2005; SEI, CSA International ANSI Z41-1999, 1991c ANSI Z87.1-2003, 1989d Eye and face protection SEI, UL, CSA International NOTE: SEI = Safety Equipment Institute; UL = Underwriters Laboratories. a As specified in OSHA regulations (29 CFR §1910). Third-party certification programs are also available to certify firefighter protective equipment to meet NFPA standards. b 29 CFR §1910.135. c 29 CFR §1910.136. d 29 CFR §1910.133.

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82 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES PPE CONFORMITY ASSESSMENT IN THE EUROPEAN UNION 5 The countries of the European Union (EU) work through the Euro- pean Commission and other organizations to ensure the safety and effec- tiveness of personal protective products. European standards and tech- nical specifications for product performance, testing, and certification are developed by the European Committee for Standardization, which works in many cases with ISO to harmonize international standards, to the ex- tent possible. Two EU directives are focused on personal protective equipment (PPE). Directive 89/656/EEC is a social directive and discusses the health and safety of individuals. Directive 89/686/EEC is a commercial directive and focuses on issues related to conformity assessment and sale of PPE products in the member countries. The directives are applicable to all uses of PPE, including, but not limited to, occupational uses. The PPE directives in the EU stipulate that products meet both a set of essen- tial requirements as well as additional requirements based on the relevant category specific to that product (Box 3-3). The health and safety essen- tial requirements directive details basic requirements related to ergonom- ics, comfort, sizing, and compatibility of different types of PPE designed for simultaneous use. To be sold in EU countries, all PPE must have the EU’s conformance mark, the CE marking (conformité européenne), with appropriate information as specified by the product category. In cases where third-party testing is required, testing must be conducted by noti- fied bodies—laboratories accredited by various organizations in accor- dance with ISO 17025. Committee Comments The committee did not identify any available data that compared worker safety before and after the conformity assessment requirements were implemented in the EU. U.S. efforts relevant to categorizing PPT will need to closely examine data that become available. The mandate that all PPT products sold in the EU have the CE mark is the major driv- er of conformity assessment efforts, and similar mandates are not availa- ble for non-respirator PPT in the United States. Issues facing the EU 5 The European Union’s documents use the term personal protective equipment (PPE).

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83 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES process include ensuring adequate participation by all the stakeholders, including worker-related organizations. BOX 3-3 European Union Certification Categories for PPE • Category 1: Includes personal protective equipment (PPE) of simple de- sign and with minimal risk, where the user can assess the level of protec- tion provided. Examples include gardening gloves, swimming goggles, and sunglasses. Manufacturers of PPE in this category submit the European Commission (EC) declaration of conformity stating that the product com- plies with all relevant provisions of the directive. Signing the declaration authorizes the manufacturer to affix the CE marking to each product. • Category 2: Includes any PPE that does not fit in Categories 1 or 3. Exam- ples include sports helmets, eye protection (except swimming goggles or eye protection against high temperatures, electrical risks, or ionizing radia- tion). Products in Category 2 are required to undergo third-party testing with a notified body and to carry a CE marking after the EC declaration of conformity is issued by the notified body. • Category 3: Includes PPE of complex design and PPE designed to “pro- tect against mortal danger or against dangers that may seriously and irre- versibly harm the health, the immediate effects of which the designer as- sumes the user cannot identify in sufficient time” (EC, 2010b). Examples include fall protection, respiratory protective equipment, and clothing de- signed for high- or low-temperature environments. Products in this catego- ry are required to undergo third-party testing by a notified body and also undergo one of two product monitoring procedures: (1) checks on the final product—the notified body carries out random production quality checks at least annually and selects an adequate sample of products for testing, or (2) monitoring of production with supervision—meeting ISO quality control systems with random audits by the notified body. The CE marking for Cat- egory 3 products includes the assigned number of the notified body re- sponsible for the production control phase. The term Category 0 has also been used to include equipment excluded from the scope of the PPE directive. Surgical masks are in this category as they are covered in another directive. However, in cases where surgical masks are intended to be used to protect the wearer against microbial or vir- al infections, they are specified as Category 3 PPE. PPE products designed and manufactured specifically for the armed forces are not covered by this directive. SOURCES: EC (2010a, 2010b).

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84 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES SUMMARY As evidenced by the descriptions throughout this chapter and sum- marized in Table 3-9, conformity assessment is conducted in a number of different ways, even within the field of PPT. Moving toward a more sys- tematic and consistent approach to PPT conformity assessment is the topic of the following chapters. REFERENCES Ayyub, B. 2002. Quality assurance for manufacturing personal flotation devices. Potomac, MD: BMA Engineering, Inc. Ayyub, B. 2008. Reclassification and risk-based compliance: Personal flotation device risk and reclassification analysis. Potomac, MD: BMA Engineering, Inc. DOJ (Department of Justice). 2010. Bulletproof vest partnership. http://www. ojp.usdoj.gov/bvpbasi/ (accessed May 4, 2010). EC (European Commission). 2010a. Guidelines on the application of Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the member states relating to personal protective equipment. http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/ppe_guidelines _en.pdf (accessed August 18, 2010). EC. 2010b. Guide to application of the directive 89/686/EEC on personal protective equipment—appendix. http://ec.europa.eu/enterprise/sectors/ mechanical/documents/guidance/personal-protective-equipment/appendix/ index_en.htm (accessed August 18, 2010). EPA (Environmental Protection Agency). 2009. Proposed revisions to the product noise labeling regulation for hearing protection devices: Fact sheet. http://www.epa.gov/air/pdfs/HPDFactSheetAugust32009.pdf (accessed August 19, 2010). EPA. 2010. Summary of the Noise Control Act. http://www.epa.gov/lawsregs/ laws/nca.html (accessed August 19, 2010). FBI (Federal Bureau of Investigation). 2008. Law enforcement officers killed and assaulted. http://www.fbi.gov/ucr/ucr.htm#leoka (accessed August 20, 2010). FDA (Food and Drug Administration). 2008. Guidance for industry and FDA staff: Medical glove guidance manual. http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm 073359.pdf (accessed August 24, 2010). FDA. 2010. Device classification. http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/Overview/ClassifyYourDevice/default.htm#introduction (accessed August 20, 2010).

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TABLE 3-9 Summary of Standards and Conformity Assessment Approaches for Selected Examples of Personal Protective Technologies (PPT) Hearing Personal Healthcare Body Firefighter Protection Flotation Respirators Respirators Worker PPT Armor PPT Devices Devices Devices Standards Voluntary consensus a Government standards Testing f First party b Third party Declaration of Conformity Assessment First party—Manufacturer’s declaration e b Third-party certification—Optionalc d Third-party Certification—Mandated NOTE: Second-party processes were not used in the examples described in this report. a Environmental Protection Agency standards for noise reduction ratings. b Not federally mandated, but required to meet NFPA criteria. c Optional is used to denote that third-party certification is not mandated by OSHA or other federal regulatory agencies. d Food and Drug Administration clearance or approval. e Not federally mandated, but required for inclusion on the NIJ Compliant Products List. 85 f Third-party oversight of testing.

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86 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Feith, K. 2010. Labeling of hearing protection devices. Presentation to the Institute of Medicine Committee on the Certification of Personal Protective Technologies, Washington, DC, April 13. GAO (Government Accountability Office). 2008. Medical devices: Challenges for FDA in conducting manufacturer inspections. GAO-08-428T. Washington, DC: GAO. GAO. 2009. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. GAO-00- 190. Washington, DC: GAO. IOM (Institute of Medicine). 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers. Washington, DC: The National Academies Press. IOM. 2010. Public health effectiveness of the FDA 510(k) clearance process: Balancing patient safety and innovation. Workshop report. Washington, DC: The National Academies Press. IOM and NRC (Institute of Medicine and National Research Council). 2008. The Personal Protective Technology Program at NIOSH. Washington, DC: The National Academies Press. Miller, L. 2010. NIJ’s Body Armor Safety Initiative and Revised Body Armor Compliance Testing Program. Presentation to the Institute of Medicine Committee on the Certification of Personal Protective Technologies, Washington, DC, April 13. Neitzel, R., S. Somers, and N. Seixas. 2006. Variability of real-world hearing protection attenuation measurements. Annals of Occupational Hygiene 50(7): 679–691. NIJ (National Institute of Justice). 2001. Selection and application guide to personal body armor: NIJ guide 100–01. http://www.ncjrs.gov/pdffiles1/nij/189633.pdf (accessed August 23, 2010). NIJ. 2008a. Ballistic-resistance of body armor, NIJ standard-0101.06. http://www. ojp.usdoj.gov/nij/pubs-sum/223054.htm (accessed August 23, 2010). NIJ. 2008b. Body armor. http://www.ojp.usdoj.gov/nij/topics/technology/body- armor/welcome.htm (accessed August 23, 2010). NIJ. 2009. National Institute of Justice Body Armor Compliance Testing Program: Administrative manual. http://www.justnet.org/Documents/Body %20Armor%20Documents/NIJ_BA_CTP_Administrative_Manual_August _5.pdf (accessed August 23, 2010). NIJ. 2010. Models that comply with the NIJ standard-0101.06 for ballistic- resistance of body armor. http://www.justnet.org/pages/BallisticCPL.aspx (accessed August 23, 2010). NIOSH (National Institute for Occupational Safety and Health). 1998. Occupational noise exposure: Criteria for a recommended standard. NIOSH 98-126. http://www.cdc.gov/niosh/docs/98-126/default.html (accessed August 23, 2010). NIOSH. 2010a. Respirator testing. http://www.cdc.gov/niosh/npptl/stps/respirator_ testing.htm (accessed July 30, 2010).

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87 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES NIOSH. 2010b. NIOSH investigation of 3M model 8000 filtering facepiece respirators as requested by the California Occupational Safety and Health Administration, Division of Occupational Safety and Health. HETA 2010- 0044-3109. http://www.cdc.gov/niosh/hhe/reports/pdfs/2010-0044-3109.pdf (accessed August 18, 2010). NIOSH. 2010c. NIOSH respirator user notices. http://www.cdc.gov/niosh/npptl/ usernotices (accessed August 18, 2010). OSHA (Occupational Safety and Health Administration). 2010. Noise and hearing conservation. http://www.osha.gov/SLTC/noisehearingconservation/ index.html (accessed July 26, 2010). U.S. Commission of Investigation Upon the Disaster to the Steamer “General Slocum.” 1904. Report of the United States Commission of Investigation Upon the Disaster to the Steamer “General Slocum,” October 8, 1904. Washington, DC: U.S. Government Printing Office. http://marine casualty.com/documents/Slocum.pdf (accessed October 5, 2010). USCG (U.S. Coast Guard). 2010a. Approval guidance for recreational PFDs/ life jackets. http://www.uscg.mil/hq/cg5/cg5214/recpfd.asp (accessed Au- gust 23, 2010). USCG. 2010b. Approval guidance for commercial PFDs/life jackets. http:// www.uscg.mil/hq/cg5/cg5214/commpfd.asp (accessed August 23, 2010). USCG. 2010c. PFD selection, use, wear, and care. http://www.uscg.mil/hq/cg5/ cg5214/pfdselection.asp (accessed August 23, 2010). Young, S. L., J. J. Isaacson, and E. C. Wisniewski. 2009. Inflatable lifejacket testing for children 15 years and under, and adult non/weak swimmers. Ann Arbor, MI: Applied Safety and Ergonomics.

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