National Academies Press: OpenBook

Certifying Personal Protective Technologies: Improving Worker Safety (2011)

Chapter: 3 Current PPT Conformity Assessment Processes

« Previous: 2 Role of Government Agencies in Conformity Assessment
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

relate to conformity assessment for non-respirator PPT. The chapter also briefly discusses the conformity assessment approach used in the European 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 conducted 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 audits, 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 respiratory 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 explosions 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 occupations. 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 regulations 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

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

(MSHA), focused on products and issues specific to mining applications. In the early 1980s, NIOSH, MSHA, and the respirator stakeholder community 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 evaluations 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 performed 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 manufacturing site undergoes a site audit at least every 2 years. Additionally, NIOSH has a product auditing program where a limited number of respirators 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

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

respirators that are alleged to be defective by wearers or others (e.g., a recent study examined N95 respirators submitted by the state of California [NIOSH, 2010b]), and runs a Certified Product Investigation Process. Once a respirator is certified, the manufacturer is not required to resubmit the device for further testing unless modifications are made. Manufacturers 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) requires 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 employers, 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 disseminate revocation notifications need to be expanded.

Committee Comments

NPPTL conducts rigorous testing of respirators and is actively involved in updates to respirator standards. The respirator conformity assessment process (summarized in Table 3-1) involves an active role for NPPTL in all phases of the process, including post-marketing testing and

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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 evaluation

NIOSH NPPTL conducts manufacturing and product audits, respirator equipment investigations, the Long-Term Field Evaluation Program for mine escape respirators, and the Firefighter Fatality Investigation and Prevention Program

Incentives/enforcement

OSHA requires NIOSH-certified respirators 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 days1 (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). Regarding 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.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

HEALTHCARE WORKER PPT

The Food and Drug Administration (FDA) has federal regulatory authority to ensure the safety and effectiveness of medications and medical devices brought to market in the United States. PPT for healthcare workers are considered medical devices and are subject to FDA evaluation and oversight.

Standards

The standards for healthcare PPT include those issued by ASTM International, the American National Standards Institute (ANSI), the Association 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 tongue 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

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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) application prior to bringing product to market. Manufacturers must be in compliance with general controls and Good Manufacturing Practices for medical glove manufacture. Broadly, this includes quality management and organization, 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 appropriate and conclusions” (FDA, 2008). Third-party testing is not required.

devices are subject to a range of general controls, which include predefined 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, production 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 devices, 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 “substantial 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 substantially from previously marketed products, particularly in a way that

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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 adverse event reports, the Manufacturer and User Facility Device Experience 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

Class

Risk to Patient or Device Wearer

Requirements

Healthcare PPT and Related Devicesa

I

Low

General standards for good manufacturing processes; most Class I devices are exempt from 510(k) submissions

  • Surgeons’ gloves (510[k] required)

  • Examination gloves (510[k] required)

  • Other surgical apparel (isolation gowns, shoe covers, caps, hoods, operating room shoes) (510[k] exempt)

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

Class

Risk to Patient or Device Wearer

Requirements

Healthcare PPT and Related Devicesa

II

Intermediate

510(k) submission

  • Surgical gowns

  • Surgical masks

  • Surgical respirators

III

High

Subject to pre-market approvals; must submit clinical evidence of safety and effectiveness

None

NOTE: The FDA uses the terms surgical gowns, isolation gowns, surgical masks, and surgical respirators and defines each in guidance documents.

aProtective 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 manufacturers, 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 appropriate 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 specifically 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 facilities seeking accreditation by the Joint Commission are the Joint Commission’s standards regarding infection control, which include expectations that respirator fit testing is conducted and updated.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

Committee Comments

The FDA conformity assessment process used for healthcare PPT (summarized in Table 3-3) is based on conformity to a “predicate,” already approved for market. Voluntary consensus standards, recognized by the FDA, are incorporated into guideline documents to assist manufacturers to demonstrate substantial equivalence to the predicate. Because these standards are not codified in federal regulations, they can potentially be amended more rapidly than federal regulations. The standards 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 development 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 require 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 assessment requirements are needed. Recent studies by the Government Accountability 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 address 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 incorporated into FDA guidance documents

Testing

First party: Manufacturers submit required information to FDA

Attestation of conformity assessment

Third party: FDA reviews product data for Class II and Class III products

Laboratory accreditation

Not applicable

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

Surveillance and post-market testing and evaluations

FDA

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, chemotherapy gloves are a subcategory of patient examination gloves, both categorized 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 categorized 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 surveillance 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-

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

cluding standards for protective ensembles for technical rescue incidents, ensembles for hazardous materials response, and PPT for emergency medical operations. NFPA standards are voluntary consensus standards, and the organization does not evaluate, test, or approve any product or PPT system. NFPA standards for fire and emergency services PPT do require that the products be certified by third-party, private-sector certifying organizations if the manufacturer chooses to assert that the product meets applicable NFPA standards.

Standards

The NFPA employs a structured process to develop standards for firefighter and emergency responder PPT. This process is designed to maximize opportunity for public and stakeholder input, with emphasis on participation from firefighters and the emergency responder community. Standards technical committees are constituted to address standards development for specific categories of PPT. The technical committees are balanced to include participation by manufacturers, fire service and emergency responders, government agency staff, and general interest members, including those from certifying organizations. NFPA standards are frequently updated and revised, typically on a 5-year schedule. Standards are developed in scheduled phases, proceeding from public announcement to development of a first draft of the standard by the technical committee. The draft standard is made available as a proposal for public comment. The technical committee then produces a report requiring that each public comment be addressed with respect to incorporation into the standard. Each technical committee that is responsible for specific categories of PPT operates with oversight from a technical correlating committee. The NFPA Standards Council is responsible for final approval of the PPT standard.

Conformity Assessment

Each NFPA PPT standard document contains a full chapter describing the requirements for certification to that standard. All products that are labeled as being compliant to the NFPA standard must meet or exceed all applicable requirements of the standard. The testing, certification, and labeling of the product is done by an accredited certifying or-

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

ganization. NFPA standards require that the certifying organization be an independent third-party organization accredited to ISO 65, General Requirements for Bodies Operating Product Certification Systems. The certifying organization is responsible for inspection, evaluation, and testing to NFPA standards to determine product compliance. The certifying organization’s laboratories must be accredited to ISO 17025 requirements for testing and calibration laboratories. Furthermore, NFPA requires that the organization that accredits the certification organizations must meet ISO 17011 requirements for accrediting conformity assessment bodies. NFPA standards do not specify which organization is used to conduct the accreditations.

NFPA standards require that for conforming products, the certifying organization’s label, symbol, or identifying mark be permanently attached to the product label or be part of the product label. It further requires that the certifying organization perform quality assurance audits and requires annual verification of product compliance by the certifying organization. NFPA PPT standards specify that manufacturers provide a quality assurance program that meets requirements specified in the standard. The certifying organization is required to establish procedures to be followed when situations are reported in which a compliant product is subsequently found to be hazardous. The certifying organization must require manufacturers to investigate complaints and returns in accordance with ISO 9001 requirements for investigating written complaints and returned products. Furthermore, the certification program requires that the manufacturer investigate product hazards and have programs for safety alerts and product recall.

Requirements and Incentives

NFPA standards and the accompanying certification are not federally mandated, but there is strong demand by workers, unions, and fire and emergency response departments for certified products. The U.S. Department of Homeland Security specifies in its grants that include purchase of PPT, that NFPA standards and third-party certification requirements must be met to use grant funds (see also Chapter 4).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

Committee Comments

The NFPA standards and their detailed requirements for conformity assessment provide a strong example of effective voluntary consensus standards coupled with a rigorous third-party certification system (Table 3-4). NFPA standards are true performance standards with pass–fail criteria developed with significant input from the stakeholder community. The standards approval process is organized and systematic, with regularly scheduled revisions. Each of the NFPA standards committees relies on substantial involvement by firefighters and emergency response personnel. The NFPA process benefits from participation and support of worker unions and associations, including the International Association of Firefighters and the National Volunteer Fire Council. While applauding the current level of involvement, the committee believes that any mechanisms that will facilitate increased end-user participation in the NFPA standards development process would contribute to further improving the standards.

It is important to recognize that the NFPA does not certify PPT; rather, the NFPA standards call for certification by private-sector certifying

TABLE 3-4 Overview of the Conformity Assessment Process for Firefighter and Emergency Responder PPT (Excluding Respirators)

Standards

Voluntary consensus standards: NFPA

Testing

To state that the product conforms to NFPA standards requires third-party testing

Attestation of conformity assessment

To state that the product conforms to NFPA standards requires third-party certification

Laboratory accreditation

NFPA details the criteria for accreditation, including meeting the relevant ISO standards

Surveillance and post-market testing and evaluation

Conducted by the certifying organization

Incentives/enforcement

Worker and employer demand, grant requirements

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

organizations and specify requirements for certification and quality assurance. The NFPA standards are thorough in stipulating that the third-party certifying organization needs to establish procedures to be followed if a compliant product is subsequently found to be hazardous, and the standards require a program of corrective action in the case of complaints, including safety alerts and product recall. One issue that was raised at the committee’s workshop was that the NFPA does not actively pursue false or fraudulent uses of assertions on product labels that the product meets NFPA standards. The committee notes that any mechanism that could potentially strengthen the enforcement aspects of compliance to NFPA standards would be worthy of consideration, including strengthening the enforcement of the incorrect use of the term “NFPA approved” on product labeling to ensure that only certified products make this assertion.

BALLISTIC-RESISTANT BODY ARMOR

Law enforcement officers wear multiple types of PPT depending on the circumstances of their work. This section focuses on the conformity assessment processes specific to ballistic-resistant body armor. From 1966 to 1971, the number of law enforcement officers killed in the line of duty each year more than doubled from 57 to 129 (NIJ, 2001). Shortly thereafter, efforts began at the U.S. Department of Justice to explore the development of lightweight, ballistic-resistant body armor and the establishment of performance standards. In 1972, the National Institute of Justice (NIJ) released the first draft standards for performance of ballistic-resistant body armor used by law enforcement personnel.2 Current efforts to certify the effectiveness of these products involve NIJ, the National Institute of Standards and Technology (NIST), and NIJ-funded centers collectively known as the National Law Enforcement and Corrections Technology Center (NLECTC). An estimated 3,000 lives have been saved by protection from effective body armor (NIJ, 2008b).

2

A similar course of events also led to the 2000 NIJ performance standards for stab-and puncture-resistant body armor in response to requests from the correctional officers’ community (NIJ, 2001).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

Standards

The original NIJ set of standards for body armor focused on penetration of the vest by a bullet (NIJ, 2001); subsequent iterations examined the effects of blunt trauma, the degradation of the armor when wet, and the effects of angled shots and multishot assaults. The most recent edition was developed through a collaboration between NIJ and the NIST Office of Law Enforcement Standards and was released in 2008 (NIJ, 2008a). The impetus for many of the recent changes was serious injury to a law enforcement agent in 2003 from bullet penetration of a certified vest (Miller, 2010). Analysis of the failed vest determined that its service life was significantly shorter than originally believed due to premature degrading of the protective fibers. The 2008 standard requires more rigorous testing, including the determination of service life by artificial aging as well as the stipulation that an increased number of vests undergo testing and further post-market assessments.

Conformity Assessment

Since 1985, NIJ has administered a voluntary compliance testing program for ballistic-resistant body armor involving pre- and post-market testing carried out by accredited independent laboratories. This effort is coordinated primarily through the NLECTC.3 More than 5,000 models have been tested since 1987, and approximately half have met the requirements for certification (Miller, 2010). Five independent private-sector laboratories are currently accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) to conduct ballistic-resistant body armor testing in accordance with the 2008 NIJ standard. In addition to NVLAP accreditation, NIJ specifies that laboratories be within the United States and be fully independent from armor manufacturers. Testing costs are paid by the manufacturers, with cost structures determined by each laboratory.

The current program requires that manufacturers submit armor models and an application package to the NLECTC National Center for ini-

3

Five NLECTC centers are funded by NIJ to work with federal, state, local, and tribal law enforcement agencies as well as corrections and criminal justice agencies on issues related to technology needs and challenges. The NLECTC National Center has responsibility for managing the Compliance Testing Program and maintaining the Compliant Products List.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

tial review. Upon acceptance, the manufacturer submits samples to one of the independent laboratories for testing. Tested samples are maintained by the NLECTC for potential future comparison and analysis. Products that meet the standard are provided an NIJ Notice of Compliance and manufacturers are authorized to use the NIJ compliance label. The label also provides information on the date of manufacture and issue. Certified products are listed on the NIJ Compliant Products List, available online (NIJ, 2010). The list provides information on the threat-level protection of the body armor, manufacturer contact, and warranty information. Renewal of compliance is required after 5 years (NIJ, 2009). The compliance-testing program includes an appeals process. Efforts are under way by NIJ and the NLECTC to implement a new post-market testing program. The follow-up program will monitor ongoing performance by randomly selecting subsequent production samples and submitting them for a subset of the original certification tests (NIJ, 2009).

Requirements and Incentives

Many law enforcement agencies base their purchasing decisions for body armor on the NIJ Compliant Products List. Additionally, the Department of Justice’s Bulletproof Vest Partnership Program, which provides matching funds to law enforcement agencies for the purchase of vests, requires that those vests be on the NIJ Compliant Products List. Since 1999, more than 13,000 jurisdictions have participated in the program and an estimated 800,000 vests have been purchased with $277 million in federal funds (DOJ, 2010).

Committee Comments

The standards and conformity assessment processes for body armor (summarized in Table 3-5) have evolved over the past 30 years. The NIJ standards (developed in conjunction with NIST) are performance based, with a clear testing protocol and well-defined pass–fail criteria. Law enforcement officers are significantly involved in the development of the standards.

The conformity assessment process for body armor is an example of third-party certification with critical involvement and oversight provided

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

by a federal agency. This level of conformity assessment is appropriate given the high degree of risk posed to law enforcement and military personnel if the product fails to provide protection. Since 2008, safety alerts about any noncompliant product have been posted on the NIJ website to inform consumers, and a well-organized list of compliant products is available online. Surveillance efforts include data collected by the Federal Bureau of Investigation on deaths of law enforcement officers that occur in the line of duty (FBI, 2008).

The Bulletproof Vest Partnership Program is an innovative example of government involvement in providing funds so that law enforcement agencies can afford to buy compliant products. These types of creative solutions are needed to promote and maintain worker safety and could be used for other types of PPT.

Although this is a voluntary conformity assessment process, factors such as worker and employer demand, purchasing requirements, potential product liability, and manufacturer reputation positively influence body armor manufacturers to obtain certification. As with respirators, issues regarding training and use of equipment also need to be addressed.

TABLE 3-5 Overview of the Conformity Assessment Process for Ballistic-Resistant Body Armor

Standards

Standards developed by NIJ and NIST

Testing

Third-party testing

Attestation of conformity assessment

Third-party certification by NIJ through NLECTC

Laboratory accreditation

NVLAP accreditation; laboratories are also required to be independent of the manufacturer and be located in the United States

Surveillance and post-market testing and evaluation

NLECTC

Incentives/enforcement

Bulletproof Vest Partnership Program, worker and employer demand

NOTE: NIJ = National Institute of Justice; NIST = National Institute of Standards and Technology; NLECTC = National Law Enforcement and Corrections Technology Center; NVLAP = National Voluntary Laboratory Accreditation Program.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

HEARING PROTECTION DEVICES

Approximately 30 million people in the United States are occupationally exposed to hazardous noise levels (OSHA, 2010). The Noise Control Act of 1972 (Public Law 92-574) vested the U.S. Environmental Protection Agency (EPA) with authority to regulate and enforce product noise emission standards and the labeling of products entering U.S. commerce regarding noise emissions and noise-reducing properties. The primary responsibilities for noise control are under the purview of state and local governments (EPA, 2010).

Standards

Since 1979, the EPA has required (40 CFR Part 211) that manufacturers of hearing protection devices provide a noise reduction rating (NRR) on the packaging. The NRR was designed to provide information to prospective purchasers and users regarding the amount of protection provided by a given device. When the labeling requirement was first proposed, the most frequent method used to characterize sound attenuation was the real ear attenuation at threshold method (described in ANSI S3.19-1974) (NIOSH, 1998).

Conformity Assessment

Manufacturers are responsible for attesting to the conformity of their products to meet the NRR designated on the product label. Hearing protection devices are tested either by the manufacturer themselves or by an independent laboratory, which then provides the testing results to the manufacturer. At the committee workshop, participants noted that EPA does not require accreditation of manufacturers’ laboratories or independent testing laboratories because the industry is composed of mostly small companies and limited product lines. Initial and recurring costs of laboratory accreditation or other third-party certification processes would increase costs of compliance with the regulation without quantifiable benefits to the public (Feith, 2010).

EPA, through an interagency agreement with the Centers for Disease Control and Prevention and NIOSH, conducts spot checks of products in the marketplace. Penalties for manufacturers who falsify certification information include product recall; a $25,000 fine for each initial product

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

violation; and a $50,000 fine for each subsequent product violation or up to a year in jail (Feith, 2010).

OSHA mandates that employers select hearing protection devices based on their NRR values when employees are exposed to noise at or above the Permissible Noise Exposure (90 decibels averaged over 8 hours and measured on the A scale) and requires employees who have a permanent threshold shift (hearing loss) to wear protective devices at 85 decibels averaged over 8 hours (29 CFR §1910.95). OSHA currently requires that the NRR value be reduced by 7 decibels to account for the fact that NRR testing is done on a different sound scale than the one used by OSHA.

The EPA is currently revising its 1979 regulations regarding hearing protection devices, and final regulations have not been published. Proposed revisions to the current regulations would require periodic testing and renewals in attesting to product conformance. The proposed changes will also address the following issues:

  • Stating a range of NRR values rather than one numerical value to provide users with information on the least and greatest levels of protection that can be achieved when used according to manufacturer instructions and product fit;

  • Revising the product label to be more user-friendly and to provide information needed to make informed decisions about the product’s level of protection (NRR values) and suggested use environment;

  • Requiring recurrent testing during the life of a product;

  • Relabeling when modifications and retesting of a product’s NRR values differ by a minimum of 3 decibels as compared to previous labeled NRR values; and

  • Introducing adjustments for “A”-weighted noise exposure and noise spectra to eliminate arbitrary product derating (EPA, 2009).

Committee Comments

An advantage of the conformity assessment process used for hearing protection devices (summarized in Table 3-6) is that it minimizes the cost to the manufacturers by requiring only first-party conformity assessment.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

TABLE 3-6 Overview of the Conformity Assessment Process for Hearing Protection Devices

Standards

EPA

Testing

First party: Manufacturers

Attestation of conformity assessment

First party: Manufacturers

Laboratory accreditation

Not required

Surveillance and post-market testing and evaluation

EPA and NIOSH

Incentives/enforcement

EPA

This can allow product innovation to easily be introduced. Current issues with this approach are focused on the test standard and testing methodology and on the length of time that has elapsed between revisions of the standard. The EPA’s proposed change to provide a range rather than a single NRR value may help to address this issue. As with respirators, fitting the hearing protection devices is also emphasized as a critically important component of the effectiveness of hearing protection devices (Neitzel et al., 2006).

The approach used by the EPA also works well because of specific regulatory authority granted through legislation that allows the EPA to impose penalties that are sufficient to discourage manufacturers from falsifying data. Whether such an approach can prohibit unscrupulous distributors from importing hearing protection devices and falsifying the NRR values is not clear. Such distributors and offshore manufacturers may not have assets that the EPA can access. Similar regulatory authority to impose significant penalties for noncompliance or fraudulent claims is not in place for other types of PPT.

PERSONAL FLOTATION DEVICES

Personal flotation devices (PFDs) are used in both occupational and recreational settings. Federal government involvement in conformity assessment for PFDs began in the mid-1800s after the loss of lives from explosions of ship boilers. The Steamboat Act of 1852 prescribed, among other measures, that passenger-carrying steamboats have on board life preservers made of suitable floating materials for all passengers. To

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

oversee compliance with this and other safety laws, nine supervisory inspectors were appointed and in the late 1800s the Steamboat Inspection Service (a forerunner of the U.S. Coast Guard) was established. A 1904 disaster on a New York City excursion vessel, the General Slocum, prompted the further development of a set of federal regulations. Of the ship’s 1,358 passengers, at least 955 died; few life preservers were used, and of those that were used, a number of safety violations were found. The most egregious was the concealment of 8-ounce bars of iron within the cork blocks that were fraudulently put in the life preservers to bring them up to the required weight (U.S. Commission, 1904). The regulations that resulted included the standardization of factory testing procedures and the use of an inspection mark.

Currently, four types of PFDs are specified for commercial or recreational selection depending on the intended use and time to rescue.4

  • Type I PFDs/Off-shore life jackets: Best for all waters where rescue may be slow coming.

  • Type II PFDs/Near-shore buoyant vests: Good for calm, inland waters, or where there is a good chance for fast rescue.

  • Type III PFDs/Flotation aids: For general boating or the specialized activity that is marked on the device such as water skiing, hunting, fishing, canoeing, kayaking, and others.

  • Type V PFDS/Special use devices: Only for special uses or conditions (e.g., boardsailing vests, commercial whitewater vests) (USCG, 2010c).

Standards

The U.S. Coast Guard (USCG) is responsible for the conformity assessment processes for PFDs under its jurisdiction. Buoyancy, strength, and design standards that PFDs are required to meet are outlined both in the CFR (46 CFR Part 160) and in voluntary consensus standards developed by ANSI/Underwriters Laboratories (UL). The CFR also outlines the requirements for acceptance of testing laboratories and the conformity assessment processes described below. USCG has examined the feasibility of probabilistic risk-based compliance standards and risk-based quality assurance processes for PFDs (Box 3-2).

4

Type IV PFDs are throwable devices including ring buoys and seat cushions (USCG, 2010c).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

BOX 3-2

Risk-Based Standards and Quality Assurance Processes

The U.S. Coast Guard has provided grant funds for, and the personal flotation device (PFD) industry has supported, development of probabilistic risk-based compliance standards (Ayyub, 2008) and risk-based quality assurance processes for PFDs (Ayyub, 2002). The risk-based compliance standards are intended to quantify the probability of a PFD saving the life of a user from drowning as a result of a marine event. For this task, risk-based models have been developed for various buoyancy methods and use environments that account for all the major scenarios leading to drowning or surviving an accidental immersion. The risk-based quality assurance for PFDs is designed to provide for varying levels or frequencies of sampling, testing, and inspections based on trends in product compliance resulting from the manufacturers’ quality assurance program and its implementation. These approaches to standards and conformance assessment could be applied to the evaluation and design of conformance assessment programs for various kinds of personal protective technologies (see Chapter 4).

Conformity Assessment

USCG is responsible for the issuance of a certificate of approval for PFDs that meet carriage requirements for a specific vessel. States generally rely on USCG approval to regulate PFDs that are used to meet their carriage and use requirements; however, for activities on private waters or where use is not regulated, non-approved PFDs can be used. For example, a number of manufacturers have been producing competition vests that have no standards or regulations other than the various rules for water skiing and wakeboarding competition.

USCG conducts a preapproval review of any new concept or design before the product is submitted for testing (46 CFR Part 160). Once a manufacturer receives Coast Guard Type Approval, a Certificate of Approval is issued for 5 years and remains valid if product sample and quality control requirements are met (USCG, 2010b). Oversight for the subsequent conformity assessment processes is conducted by a USCG-recognized laboratory. Currently, UL is the only testing and certifying organization authorized by USCG. Production testing of PFDs to meet the required standards is conducted by the manufacturer under the oversight of UL. After testing requirements have been met, the product is given USCG approval and a UL listing. UL releases labels to the manufacturer that have the required text, including specification that the prod-

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

uct was “Inspected and tested in accordance with U.S. Coast Guard regulations” 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 manufacturing 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 evaluation efforts, manufacturers are required to send samples of wearable recreational PFDs to UL testing facilities once a year for inspection and testing.

Requirements and Incentives

Incentives for PFD conformity assessment include demand for certified 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 authority, but changes to the standards require more lengthy processes. For example, 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 probabilistic 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.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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 assessment

Third party

Laboratory accreditation

Approved by USCG

Surveillance and post-market testing and evaluation

Conducted by third-party certifying organization

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 implications of having only one testing and certifying organization, but acknowledges that the system has been working for many years.

PROTECTIVE CLOTHING FOR PESTICIDE OPERATORS

In the United States, protective clothing required for pesticide operators is under the jurisdiction of the EPA. The requirements are mandated through CFR 40 with details provided as part of 40 CFR Part 170, Worker 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 Specification for Protective Clothing Worn by Operators Applying Pesticides, was approved as a performance specification for protective clothing for pesticide operators. An equivalent ISO standard draft is now under review.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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 requirements 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 declaration of conformity for Class 1 products (low potential risk) and third-party certification required for Classes 2 and 3 (medium and high potential 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 regulations, 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 manufacturer chooses to certify the performance of its PPT products (other than respirators), third-party certifying organizations can test the product to determine 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

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

programs by testing and certifying a broad range of safety and protective products used occupationally and recreationally. Third-party organizations generally undergo accreditation processes to affirm that the specific certification program meets ISO Guide 65 and other required standards. As noted in Table 3-8, voluntary third-party certification programs are available for a number of types of PPT. Some certifying 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 certification 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 Standard(s)a

Examples of Certifying Organizations

Head protection, hard hats

ANSI Z89.1-2003, 1997, 1986b

SEI, UL, CSA International

Protective footwear

ASTM F2412-2005; ANSI Z41-1999, 1991c

SEI, CSA International

Eye and face protection

ANSI Z87.1-2003, 1989d

SEI, UL, CSA International

NOTE: SEI = Safety Equipment Institute; UL = Underwriters Laboratories.

aAs specified in OSHA regulations (29 CFR §1910). Third-party certification programs are also available to certify firefighter protective equipment to meet NFPA standards.

b29 CFR §1910.135.

c29 CFR §1910.136.

d29 CFR §1910.133.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

PPE CONFORMITY ASSESSMENT IN THE EUROPEAN UNION5

The countries of the European Union (EU) work through the European Commission and other organizations to ensure the safety and effectiveness of personal protective products. European standards and technical 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 extent 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 essential requirements as well as additional requirements based on the relevant category specific to that product (Box 3-3). The health and safety essential requirements directive details basic requirements related to ergonomics, 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 notified bodies—laboratories accredited by various organizations in accordance 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 driver of conformity assessment efforts, and similar mandates are not available 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).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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 design and with minimal risk, where the user can assess the level of protection 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 complies 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. Examples include sports helmets, eye protection (except swimming goggles or eye protection against high temperatures, electrical risks, or ionizing radiation). 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 “protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time” (EC, 2010b). Examples include fall protection, respiratory protective equipment, and clothing designed for high- or low-temperature environments. Products in this category 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 Category 3 products includes the assigned number of the notified body responsible 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 viral 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).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

SUMMARY

As evidenced by the descriptions throughout this chapter and summarized in Table 3-9, conformity assessment is conducted in a number of different ways, even within the field of PPT. Moving toward a more systematic 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/ucm073359.pdf (accessed August 24, 2010).

FDA. 2010. Device classification. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm#introduction (accessed August 20, 2010).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

TABLE 3-9 Summary of Standards and Conformity Assessment Approaches for Selected Examples of Personal Protective Technologies (PPT)

 

Respirators

Healthcare Worker PPT

Body Armor

Firefighter PPT

Hearing Protection Devices

Personal Flotation Devices

Standards

Voluntary consensus

 

 

 

Government standards

 

 

a

Testing

First party

 

 

 

f

Third party

 

b

 

 

Declaration of Conformity Assessment

First party—Manufacturer’s declaration

 

 

 

 

 

Third-party certification—Optionalc

 

 

e

b

 

 

Third-party Certification—Mandated

d

 

 

 

NOTE: Second-party processes were not used in the examples described in this report.

aEnvironmental Protection Agency standards for noise reduction ratings.

bNot federally mandated, but required to meet NFPA criteria.

cOptional is used to denote that third-party certification is not mandated by OSHA or other federal regulatory agencies.

dFood and Drug Administration clearance or approval.

eNot federally mandated, but required for inclusion on the NIJ Compliant Products List.

fThird-party oversight of testing.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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).

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

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://marinecasualty.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 August 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.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×

This page intentionally left blank.

Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 55
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 56
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 57
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 58
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 59
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 60
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 61
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 62
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 63
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 64
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 65
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 66
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 67
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 68
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 69
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 70
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 71
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 72
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 73
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 74
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 75
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 76
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 77
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 78
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 79
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 80
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 81
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 82
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 83
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 84
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 85
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 86
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 87
Suggested Citation:"3 Current PPT Conformity Assessment Processes." Institute of Medicine. 2011. Certifying Personal Protective Technologies: Improving Worker Safety. Washington, DC: The National Academies Press. doi: 10.17226/12962.
×
Page 88
Next: 4 Impact and Issues in Conformity Assessment for PPT »
Certifying Personal Protective Technologies: Improving Worker Safety Get This Book
×
Buy Paperback | $59.00 Buy Ebook | $47.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

When you purchase a product, you expect it to work. Construction workers on high-rise buildings need to be confident that their safety harnesses will arrest a fall. Firefighters need to know that their gloves and other protective equipment can withstand high temperatures. Healthcare workers administering highly toxic chemotherapy agents need to know that their gloves will withstand penetration. For personal protective technologies (PPT)—where the major purpose of the product is to protect the wearer against a hazard—a deficit in product effectiveness can mean injury, illness, or death. Examining the extent to which products meet specific performance or design criteria is the focus of conformity assessment efforts. For PPT conformity assessment, the ultimate goal is preventing worker illness, injury, or death from hazardous working conditions.

Certifying Personal Protective Technologies focuses on conformity assessment for occupational PPT—ensuring that PPT are effective in preventing or reducing hazardous exposures or situations that workers face in their jobs. Because respirators already have an extensive testing and conformity assessment process in place, this book specifically addresses conformity assessment processes for other types of PPT, including eye and face protection, gloves, hearing protectors, and protective clothing.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!