2
Role of Government Agencies in Conformity Assessment

1852

Congress passed a law requiring all commercial steamboats to carry a personal flotation device for every passenger on board and to set up a Board of Supervising Inspectors (Steamboat Act of 1852)

1906

Meat Inspection Act

U.S. Department of Agriculture became responsible for domestic meat inspection

1910

Bureau of Mines was established; developed a program of respirator research, performance testing, and analysis (Public Law 61-179)

1938

Federal Food, Drug, and Cosmetic Act (Public Law 75-717)

Act required new drugs to be shown safe before marketing—starting a new system of drug regulation

Many U.S. government agencies have been and continue to be active in ensuring the consistency and safety of products and services through a wide range of activities. This chapter explores the range of possible roles for federal agencies, provides examples of how these roles are implemented both for personal protective technologies (PPT) and for other consumer and industrial products, and highlights the committee’s thoughts on the strengths and limitations of these roles as specifically related to improving non-respirator PPT for worker safety and health.

For many products there is no federal role, or only a limited role, in conformity assessment. Many products go directly into the marketplace, where consumer preferences, pricing, product recalls, market compliance



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2 Role of Government Agencies in Conformity Assessment 1852 Congress passed a law requiring all commercial steamboats to carry a personal flotation device for every passenger on board and to set up a Board of Supervising Inspectors (Steamboat Act of 1852) 1906 Meat Inspection Act U.S. Department of Agriculture became responsible for domestic meat inspection 1910 Bureau of Mines was established; developed a program of respirator research, performance testing, and analysis (Pub- lic Law 61-179) 1938 Federal Food, Drug, and Cosmetic Act (Public Law 75- 717) Act required new drugs to be shown safe before marketing— starting a new system of drug regulation Many U.S. government agencies have been and continue to be active in ensuring the consistency and safety of products and services through a wide range of activities. This chapter explores the range of possible roles for federal agencies, provides examples of how these roles are imple- mented both for personal protective technologies (PPT) and for other con- sumer and industrial products, and highlights the committee’s thoughts on the strengths and limitations of these roles as specifically related to im- proving non-respirator PPT for worker safety and health. For many products there is no federal role, or only a limited role, in conformity assessment. Many products go directly into the marketplace, where consumer preferences, pricing, product recalls, market compliance 33

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34 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES surveys, and other market forces (e.g., liability, manufacturer reputation) help sort out the effective or consumer-preferred products. Products may be designed to meet specific voluntary consensus standards, but with li- mited or no testing to see if the product meets the standard. Other prod- ucts may have little or no production testing or inspection to ensure that they continue to meet their design parameters. Products that have exten- sive conformity assessment processes often are those whose failure could significantly impact health or safety. In keeping with the study task, this report focuses on the role of agencies at the federal level. However, it is important to note that state and local government agencies also often play a critical role in standards development and conformity assessment. For example, water quality testing is largely under state and local jurisdiction (Breitenburg, 1997b; EPA, 2010). This chapter discusses each of the following conformity assessment functions (Figure 2-1) and potential roles for government agencies with the committee’s appraisal of the strengths and challenges of those roles as it relates to conformity assessment efforts for non-respirator PPT: • Standards development, a precursor to conformity assessment; • Product testing; • Accreditation of laboratories and certifying organizations; • Declaration of conformity and product certification; • Communication; • Incentives and enforcement; • Surveillance and post-marketing testing and evaluation; and • Other roles, including conducting research to inform standards and develop test methods, convening of stakeholders, and training. STANDARDS DEVELOPMENT The antecedent to a strong conformity assessment process is having rigorous standards in place. Once standards are available that set the cri- teria for product performance, testing, and test methods, then a conformi- ty assessment process can be developed to assess the product’s ability to meet those criteria. Where possible, standards specify performance crite- ria rather than design criteria to allow for greater flexibility in developing

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35 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT Accreditation of testing laboratories and certifying organizations Testing the Standards for Follow-up efforts Declaration of product to product including communication, conformity meet the performance surveillance and assessment standards enforcement Voluntary consensus First Party standards First Party (manufacturer) Second Party Government Second Party (user, supplier) standards Codified Third Party Third Party in CFR (independent) (certification) Guidance documents or other documents FIGURE 2-1 Overview of conformity assessment options. NOTE: CFR = Code of Federal Regulations. innovative products. In addition to setting the specifications for mini- mum requirements for acceptable products, standards also can provide a basis for comparing products, as well as outlining preferred approaches for selection, use, care, and maintenance. Testing methods are either re- ferenced or included in the standards along with pass–fail criteria so that conformance can be assessed consistently among testing entities and determinations can be made regarding the product’s ability to meet the re- quired specifications. Standards development organizations and government agencies are the two sources for PPT product standards. Voluntary Consensus Standards Voluntary consensus standards for the manufacturing, performance, and testing of products are developed by national and international stan- dards development organizations. These organizations work through ex- pert committees consisting of representatives from government agencies, manufacturers, employers, academia, and end users. In the United States,

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36 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES standards for PPT are developed by ASTM International (formerly American Society for Testing and Materials), the Association for the Advancement of Medical Instrumentation, and the National Fire Protec- tion Association (NFPA), as well as by many organizations under the auspices of the American National Standards Institute (ANSI), which sets the requirements for consensus and balance, oversees the standards development process, and approves standards that bear the ANSI name. 1 Among the organizations developing ANSI standards for PPT are the American Industrial Hygiene Association, American Society of Safety Engineers, American Welding Society, and the International Safety Equipment Association. In Canada, PPT standards are developed by the Canadian Standards Association (CSA), which is also a third-party certi- fication body. European standards for PPT are set by the European Committee for Standardization (CEN). For some types of PPT, efforts are underway to develop international standards through the International Organization for Standardization (ISO). Each standards development organization has its own set of rules (e.g., frequency of updating standards, membership requirements), with a number of the standards organizations receiving ANSI accreditation. Some organizations develop test specifications while others develop standards that include a set of requirements for conformity assessment (e.g., NFPA’s PPT standards specify a requirement for third-party certi- fication; see Chapter 3). Voluntary consensus standards can be used as the basis for govern- ment conformity assessment programs, such as the Food and Drug Ad- ministration’s (FDA’s) use of ASTM and other voluntary consensus standards for medical devices. Additionally, voluntary consensus stan- dards may be specified in government regulations, such as Occupational Safety and Health Administration (OSHA) requirements for protective helmets to meet ANSI Z89.1 standards (29 CFR §1910.135). Govern- ment agency staff members often participate in the development of vo- luntary consensus standards, and in some cases take leadership roles in moving these standards through the consensus process. National Personal Protective Technology Laboratory (NPPTL) staff members actively par- ticipate in voluntary standards development by serving on a number of standards committees for ASTM, ANSI, ISO, and NFPA (Box 2-1). 1 Although it does not develop standards itself, ANSI is recognized as the national stan- dards body of the United States and administers the U.S. participation in international standards bodies, such as the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC), where membership is by country.

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37 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT BOX 2-1 Examples of NPPTL Participation in Voluntary Standards and Guidelines Development AIHA committees on respiratory protection and protective clothing and equipment ANSI committee on eye and face protection ANSI Z88 committees on respiratory protection ASTM E54 committees on homeland security applications ASTM E56 committee on nanotechnology ASTM F23 committees on personal protective clothing and equipment IAB committees on equipment standardization for homeland security ISO committees on respiratory protection, human factors, and eye and face protection NFPA technical committees on fire-protective clothing, respiratory protection, and safety equipment NIJ Special Technical Committee on law enforcement CBRN protective ensem- bles NOTES: AIHA = American Industrial Hygiene Association; ANSI = American National Standards Institute; ASTM = ASTM International (formerly the Ameri- can Society for Testing and Materials); IAB = InterAgency Board for Equipment Standardization and Interoperability; ISO = International Organization for Stan- dardization; NFPA = National Fire Protection Association; NIJ = National Insti- tute of Justice. In general, the voluntary standards organization has no vested inter- est or specific role to play in the testing of PPT. Some certified products will have the name of the standards organization on its label (e.g., NFPA), while others will use the certifying organization’s or accredited testing laboratory’s mark on their product label (e.g., the “UL” mark from Underwriters Laboratories). Government Standards For some products, state or federal government agencies have the re- sponsibility for developing and revising design, performance, and testing standards. These are often the result of long-standing legislatively man- dated commitments (e.g., personal flotation devices regulations, respira- tor regulations, hearing protection ratings) or are in areas where federal agencies have specific responsibilities often not filled by other organizations.

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38 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES As will be discussed in Chapter 3, testing and certification require- ments for respirators are detailed in the Code of Federal Regulations (CFR) in 42 CFR Part 84. The National Institute for Occupational Safety and Health’s (NIOSH’s) NPPTL is responsible for drafting and submit- ting changes to the regulations through the federal rulemaking processes. Respirator regulations are often specific for each class of respirators (e.g., air-purifying, self-contained breathing apparatus). NIOSH has adopted a modular approach to updating the respirator regulations and is involved in various stages of the rulemaking process on changes to spe- cific sections. Other standards developed by government agencies in- clude the military specifications and military standards developed and used by the U.S. Department of Defense (DoD); DoD continues to move toward increased use of voluntary consensus standards and commercial specifications where available (GAO, 1994). Government’s involvement in conformity assessment often involves a combination of federal requirements and voluntary consensus stan- dards. Environmental Protection Agency (EPA) regulations require that hearing protective devices be tested according to an ANSI standard, while the requirements regarding noise reduction ratings for hearing pro- tective devices are detailed in federal regulations found in 40 CFR Part 211. The FDA’s process for approving medical devices incorporates vo- luntary consensus standards into FDA guidance documents. Similarly, the National Institute of Justice (NIJ) standards for ballistic-resistant body armor are detailed in NIJ standards documents. Committee Comments One of the challenges of using codified government standards or regulations is the amount of time and effort required to propose and im- plement changes. Changes to the CFR go through multiple cycles of comment, revision, and changes. The slow process can stifle innovation. Barriers to frequent revisions may also have an impact on available re- sources. For example, the CFR schedule that details financial fees charged to manufacturers for respirator testing has not changed since 1972 and is inadequate for meeting current costs of respirator testing and certification (IOM and NRC, 2008). Other parts of the NIOSH budget are therefore being used to address those costs. Innovative technologies and products that are developed to mitigate new hazards or the same hazard in a different environment are often the

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39 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT genesis of new voluntary consensus standards, which can provide per- formance criteria in a timely manner. For non-respirator PPT standards, development of voluntary consensus standards is the preferred avenue. Although these standards can also take time to develop and revise (e.g., NFPA standards are normally on a 5-year rotating revision plan), new standards can be added or revisions made to adapt to innovations in the marketplace. The National Technology Transfer and Advancement Act (Public Law 104-113) encourages federal government agencies to be in- volved in relevant voluntary consensus standards development. NPPTL is active in this area, and efforts to continue this involvement are encour- aged. The committee emphasizes the need for standards to be performance- based, to the extent possible, to allow for greater innovation than design- based requirements. Pass–fail criteria and detailed test methods are keys to ensuring consistent testing and reporting. Increased attention is being paid to issues of integrating the various types of PPT into wearable and effective PPT ensembles, as will be further discussed in Chapter 4. The development of valid standards that have relevant application to PPT use in the workplace requires input from a wide range of stakehold- ers. Often voluntary standards organizations have difficulty achieving proper balance in their standards committees as parties other than manu- facturers, particularly end users, may have financial constraints that do not allow them to attend meetings. ANSI accreditation of standards de- velopment organizations includes the requirement for balanced commit- tees and stipulates that it is incumbent upon the standards development organizations to maintain this balance. Innovative methods need to be used that allow other groups such as end users to participate in standards development in order to achieve meaningful results. The committee is optimistic that, with new communication tools (e.g., remote/virtual meet- ings), voluntary standards will achieve such balance. Where NPPTL or other government agencies choose to directly participate in voluntary standards committees, committee balance and underrepresentation of key interest groups needs careful consideration. PRODUCT TESTING Testing to meet product standards is conducted either in-house, by the manufacturer or purchaser, or by an independent third-party laborato- ry, each of which may be an accredited laboratory. Some certifying or-

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40 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES ganizations (e.g., UL) have accredited in-house testing facilities and oth- ers (e.g., Safety Equipment Institute [SEI]) use outside accredited third- party laboratories. Valid product testing follows specific testing metho- dologies outlined in the standards or in other approved documents. Inde- pendent testing laboratories can be private, public, nonprofit, or for- profit. First-party testing is conducted by the product manufacturer. Many manufacturing companies have extensive testing facilities and test their own products and those of their competitors. In many cases, when prod- uct testing is performed through a first-party laboratory paradigm, it is done in situations where low risk is associated with noncompliance. If users are dissatisfied with the product, they can purchase another product or brand in the marketplace. Generally, the government is not involved in this type of testing or assessment. For example, a consumer product, such as cell phone batteries, may undergo internal testing only, or the manu- facturer may decide to get input from an independent third-party testing and certification process to determine if the batteries conform to Institute of Electrical and Electronics Engineers (IEEE) standards (UL, 2010). The batteries pose low hazardous risk to the consumers and, if dissatis- fied with the product, consumers can purchase other brands. Second-party testing is conducted by the retailer or the purchaser. Although not as common as first- or third-party testing, some retailers put considerable resources into verifying that the product meets the re- quirements (e.g., lead levels in children’s toys) through second-party testing. Third-party testing is conducted by an independent laboratory or cer- tifying organization. In many cases third-party testing is done by private- sector laboratories, although this work is also conducted by government laboratories. For example, UL and SEI conduct or oversee third-party testing and offer voluntary third-party certification programs for protec- tive helmets and eyewear (testing to meet ANSI and ASTM standards). For body armor, private-sector laboratories are approved by the National Law Enforcement and Corrections Technology Center to conduct testing. Government laboratory testing includes respirator testing at NPPTL. For some non-PPT products and marketable goods, federal and state government agencies are also involved in inspections that involve as- sessments of product characteristics that do not need laboratory testing or are not easily tested in the lab (Gillerman, 2004). Federal responsibilities can involve both laboratory testing and onsite inspections. For example, federal and state meat inspection procedures involve on-site inspections

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41 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT of slaughtering or processing facilities and live animal and carcass in- spections as well as laboratory tests of tissue samples (USDA, 2008). Committee Comments Independent testing by accredited third-party laboratories and certi- fying organizations provides greater and more transparent assurance that the product meets the required criteria; this is especially important for PPT used to reduce moderate to high risk of worker injury or illness. One major reason for government agencies to do the testing is to provide an independent assessment of the product. However, for most products this role can also be filled by accredited third-party private-sector laborato- ries and certifying organizations. Issues such as fees for product testing are more easily handled and updated in private-sector organizations. NPPTL devotes a significant portion of its resources to do rigorous testing and the associated conformity assessment efforts for respirators. As noted above, challenges in this process include updating the manufac- turer fee schedules because the schedules are part of federal regulations. From the committee’s perspective, NPPTL can use its extensive exper- tise in PPT to effectively provide input on product testing processes in- cluding research on test methods. ACCREDITATION OF LABORATORIES AND CERTIFYING ORGANIZATIONS Accreditation organizations verify whether the testing laboratory or certifying organization is equipped and capable of performing the re- quired test methods and evaluations and whether it meets other opera- tional requirements that include independence, staff qualifications, strong quality assurance programs, and acceptable recordkeeping requirements (Breitenberg, 1991; Gillerman, 2004). International standards for accre- ditation are detailed in ISO standards, e.g., ISO 17025:2005 and ISO Guide 65 (ISO/IEC, 1996, 2005). In addition to laboratory accreditation, which is done by federal, state, local, and private-sector programs, there are also organizations that accredit the accrediting bodies and ensure a further level of adherence to quality testing and certification processes. NFPA standards require that the certifying organizations and the accre- diting bodies be accredited to meet ISO standards, but do not specify

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42 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES which organization is used to conduct the accreditations. NFPA stan- dards state that the certifying organization shall be “accredited for per- sonal protective equipment in accordance with ISO Guide 65, General Requirements for Bodies Operating Certification Systems. The accredita- tion shall be issued by an accreditation body operating in accordance with ISO 17011, General Requirements for Accreditation Bodies Accre- diting Conformity Assessment Bodies” (NFPA 1994). In the private sec- tor there are accreditation bodies, such as ANSI and the American Association for Laboratory Accreditation (A2LA), that accredit testing laboratories and certification bodies to ISO 17025 and ISO 65. Several laboratory accreditation programs are operated by federal agencies (Breitenberg, 1991). OSHA’s Nationally Recognized Testing Laboratories (NRTL) program accredits third-party, private-sector labor- atories that test (and often certify) electrical equipment and other workplace materials (OSHA, 2010b). Under this voluntary program, each NRTL-accredited laboratory must be reviewed at least once every 5 years. The NRTL program specifies the product standards used in testing and requires that the laboratories be independent of the product’s manu- facturer, supplier, and vendor. Laboratories accredited in the NRTL pro- gram are required to perform inspections of factory production runs and conduct field inspections to ensure that the certifier’s identifying mark or label is present on the product. The NRTL program is available for la- boratories in the United States as well as internationally if that foreign country accepts U.S. certification. The National Institute of Standards and Technology (NIST) conducts the National Voluntary Laboratory Accreditation Program (NVLAP). This program accredits laboratories to conduct one or more of a wide range of testing or calibration protocols. Accreditation programs under NVLAP include those for chemical calibration, information technology security testing, personal body armor, energy-efficient light products, thermal insulation materials, and a wide variety of commercial products (NIST, 2010). The NVLAP accreditation program is available for partici- pation by commercial laboratories, manufacturer’s in-house laboratories, university laboratories, and government laboratories. Each laboratory must renew its accreditation annually. In addition to federal programs, there are a number of private-sector for-profit and not-for-profit laboratory accreditation programs. The Con- sumer Product Safety Commission (CPSC), for example, mandates that third-party testing laboratories must be accredited by an International Laboratory Accreditation Cooperation–Mutual Recognition Arrangement

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43 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT signatory accrediting body and the accreditation must be registered with and accepted by the CPSC (CPSC, 2010a). Committee Comments The committee identified a number of organizations that accredit laboratories and certifying organizations to test and certify non-respirator PPT. For future new conformity assessment processes for these products, the committee believes the primary stipulation could be that accrediting laboratories and certifying organizations meet ANSI/ISO standards for quality assurance. DECLARATION OF CONFORMITY AND CERTIFICATION Who declares or attests that the product meets the requirements and standards? What data are used to attest to the conformity? These ques- tions have many varied answers. Certain products pose little risk to the end user, and in those cases the consumer and the marketplace sort out the high-quality products from those of low quality. For some products it is easy for the consumer to determine if the product works consistently over time, but for other products the only way to know if a product will be effective is to test it. Consumers need verification that tests have been conducted, and that the product has met the expected criteria. The attes- tation or declaration of conformity can be done by the manufacturer (first party), by the purchaser (second party), or by an independent third party. First-Party Declaration of Conformity For many products sold in the United States, the manufacturer dec- lares that the product conforms to relevant requirements and meets the industry standards. This declaration is based in some cases on data gen- erated in the manufacturer’s laboratory and in other cases on data gener- ated by a third-party testing laboratory. For example, manufacturers of hearing protective devices attest to the noise reduction level. Although a manufacturer’s declaration is often termed self-certification, as noted below, the term certification is more narrowly defined.

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44 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Second-Party Declaration of Conformity Purchasers become involved in conformity assessment, particularly when they serve as a link between the manufacturer and the general pub- lic or end-user consumer. Wholesalers or retailers may verify that a product meets standards before putting the merchandise on store shelves. Second-party declarations may also be made by manufacturers who veri- fy and attest that the component parts from other manufacturers meet the requisite standards and can thus enter the assembly process. Third-Party Declaration of Conformity Although the term certification is often used interchangeably and colloquially to encompass all forms of conformity assessment, the term has a much more specific definition that requires independent third-party involvement. ISO defines certification as “third-party attestation related to product, processes, systems, or persons,” with attestation defined as the “issue of a statement, based on a decision following review that ful- fillment of specified requirements has been demonstrated” (ISO/IEC, 2004). Certification encompasses both a verification of testing data and follow-up product and manufacturing audits. Third-party attestation of conformity provides the verification by an organization that is not the seller or buyer and thus offers a more independent appraisal. Third-party declaration is based in some cases on testing or inspection data from the manufacturer, and in other cases on data generated by a third-party test- ing laboratory. Examples of the range of approaches include the FDA’s drug ap- proval process, which provides an assessment by FDA reviewers of data supplied by the pharmaceutical or medical device manufacturers or re- lated entities (see Chapter 3). The NIOSH respirator certification process conducted by NPPTL follows a different model in which the testing is done by the government laboratory charged with verifying that the prod- ucts meet the requisite standards. In both processes there are post- marketing testing and evaluation components, including product audits and manufacturing site audits. Requirements and timelines for recertifi- cation vary.

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45 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT Committee Comments The committee believes each conformity declaration approach has value. Each serves a purpose, depending on the type of product and the nature of the marketplace. Given that most PPT products are designed specifically to prevent worker illness, injury, or death, third-party certifi- cation (declaration of conformity) would be the preferred approach. In- dependent verification and attestation that the product meets the requisite standards gives increased assurance to the worker of product effective- ness. Currently, many approaches to conformity assessment for non- respirator PPT require only first-party declaration of conformity. For ex- ample, OSHA regulations for protective helmets used in the workplace require that the products meet a specific standard, but third-party certifi- cation is not required. Voluntary third-party certification is available from several private-sector testing and certifying organizations. For ex- ample, SEI and UL offer certification programs for protective helmets and fall protection harnesses. Manufacturers can have their products cer- tified and thus meet employer and worker demands for certified fall pre- vention equipment. Further efforts are needed to explore whether third- party certification should be federally mandated for some non-respirator PPT products or what incentives could be put in place to encourage third- party testing and certification. COMMUNICATION: CERTIFICATION MARKS AND LABELS Because the entire conformity assessment process is focused on get- ting safe and effective products to the end users and consumers, informed purchasing decisions need to be made—and communication is critical. Purchasers need to know what products have been deemed to meet the relevant standards and what products have not. Communicating confor- mity assessment generally takes the form of either a certification mark or the inclusion of the product on a list of certified or approved products. Additionally, certificates of conformity are used to indicate that all es- sential characteristics of the product have been assessed and have met certain standards. The owner of the certification mark is responsible for the certification, including determining the requirements for certification. Certification marks are often, but not always, registered marks with the U.S. Patent and Trademark Office (Breitenberg, 1997a; USPTO, 2010).

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46 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Many private-sector organizations have a specific logo or mark; for ex- ample, the Woolmark issued by Australian Wool Innovation Limited attests to wool quality and performance criteria (AWI, 2010). Private- sector PPT-related certification marks include the UL, SEI, and CSA designations. According to the U.S. Patent and Trademark Office, three types of cer- tification marks are used: (1) those that certify goods or services originate from a certain region (e.g., Florida orange juice); (2) those that certify goods or services that meet certain quality, material, safety, or manufactur- ing standards; and (3) those that certify the maker of the product or service (e.g., work or labor performed by a member of a union) (USPTO, 2010). The certification mark does not need specific wording—in fact, a design can be used. The accompanying proof of conformity, however, should in- dicate: “the identity of the certification body (and any other testing body if applicable) and any relationship that the body(s) may have to the manufac- turer; the lot, batch, or other production information to allow traceability to the production source and time of production; the date when the certif- icate was issued; and the officer of the company responsible for its is- suance” (Breitenberg, 1997a). In addition, the supplier, type or model number, and all important safety and maintenance instructions should be included. Government agencies can issue certification marks; for example, the Federal Communications Commission uses a mark for computers and other electronics (FCC, 2010). Detailed certification labels are used by NIJ and NIOSH to denote certified products. These agencies also use online lists of certified products as another way to communicate which products have met testing criteria. The NIOSH Certified Equipment List provides details on certified respirators, including the related components (NIOSH, 2010d); NIJ’s Body Armor Compliant Products List also pro- vides product information (NIJ, 2010). The InterAgency Board for Equipment Standardization and Interoperability (IAB) 2 provides a Stan- dardized Equipment List through the Responder Knowledge Base on its website as a guideline for local, state, and federal responder units in- volved in preparing for and responding to hazardous events (IAB, 2010). Private-sector third-party certifying organizations, such as SEI, UL, and CSA, also maintain online certified product lists. Public listing is re- 2 Founded by the DoD and the Department of Justice in 1998, the IAB brings together local, state, and federal agencies and organizations to prepare for and respond to emer- gencies and disasters. The IAB focuses on issues relevant to interoperability, compatibili- ty, and standardization of response equipment and processes.

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47 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT quired as part of meeting the ISO requirements to receive accreditation as a certifying entity. A major challenge in conformity assessment is enforcing the certifi- cation mark and identifying and policing fraudulent use. NIOSH has had several occasions in recent years in which respirators with labels that indicated NIOSH certification were determined not to be NIOSH- certified products. In those cases, NIOSH has contacted the manufactur- ers of mislabeled products and requested that the product be relabeled or recalled. NPPTL staff have also sent out user notices and posted the in- formation identifying the fraudulent respirators on the NIOSH website (NIOSH, 2010c). Manufacturers of certified products are often vigilant in identifying non-certified products offered by their competitors. Committee Comments Communication about certified products is a valuable role for gov- ernment agencies to fulfill because the agencies can provide websites or other tools that offer lists of certified products from multiple certifying organizations. No comprehensive list is currently available of non- respirator PPT products that meet the required standards or other regula- tions. In December 2009, NPPTL released its Respirator Trusted Source Information Page (NIOSH, 2010a). A similar effort with a central data- base website for other types of PPT would be a valuable resource. An information source would be especially important for small and large employers that may not be affiliated with a consolidated purchasing ar- rangement, for self-employed individuals, and for low-wage temporary workers so they can make informed decisions about quality PPT. Manu- facturers also have responsibilities to provide product use instructions that can be readily understood. INCENTIVES AND ENFORCEMENT Investing in and adhering to conformity assessment processes can be driven by positive incentives or by legal mandates or penalties. Worker, union, and employer demand for certified products is one of the positive driving forces for fire protection PPT. Local fire departments often stipu- late that contracts be awarded for PPT products that meet NFPA stan- dards as evidenced by third-party testing and certification. Similarly,

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48 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES financial incentives can include stipulations in federal contracts that only certified products can be purchased using federal grant funds (see Chap- ter 4). This is demonstrated by the success of the Bulletproof Vest Part- nership Program with the Department of Justice (DOJ, 2010). Since 1999, more than 13,000 jurisdictions have participated in the Bulletproof Vest Partnership Program, which provides matching funds to law en- forcement agencies if they purchase body armor from the NIJ Compliant Product List (NIJ, 2010). The Department of Homeland Security (DHS) also requires that all emergency response equipment purchased with grant funds must be on the IAB’s Authorized Equipment List. Some government agencies have the jurisdiction to issue regulatory requirements, issue stop use alerts, or impose penalties for the use of noncompliant products. For example, OSHA requires workplaces to use NIOSH-certified respirators and U.S. Coast Guard-approved personal flotation devices, and can issue citations and penalties for noncom- pliance. Both the CPSC and the EPA have the authority to impose fines for noncompliance with safety standards. Committee Comments NIOSH does not have regulatory authority for nonrespirator PPT and cannot require or enforce requirements for conformity assessment processes. Current OSHA regulations specify the voluntary consensus standards that should be met for various types of non-respirator PPT (see, e.g., Table 3-8), but do not specify a requirement for conformity assess- ment processes to ensure that those standards are being met. If deemed appropriate for other types of PPT (particularly PPT used in medium- and high-risk work environments), OSHA and the Mine Safety and Health Administration could establish regulations requiring third-party declaration of conformity (certification). SURVEILLANCE AND POST-MARKETING TESTING AND EVALUATION Monitoring to ensure ongoing compliance is an integral part of third- party certification and is also built into other conformity assessment sys- tems. Pre- and post-marketing testing and evaluation efforts include the manufacturing and product audits conducted on the products and manu-

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49 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT facturing sites (Gillerman, 2004). Product assessments may include test- ing of products selected at random from retailers or from the production line. These ongoing efforts help ensure consistency in product quality and aim to avoid selection bias, that is, having manufacturers choose a “golden sample” for analysis. In addition, health surveillance efforts are needed to assess the im- pact on the health and safety of the worker. Occupational health surveil- lance is defined as the systematic collection and analysis of occupational injuries, illnesses, hazards, and exposures (NIOSH, 2010e). The FDA, for example, has several communication avenues for the reporting and communication of adverse events and conducts manufac- turing and import inspections. The NIOSH respirator certification pro- gram involves both site and product audits in addition to several specific follow-up programs (see Chapter 3). New initiatives for body armor are requiring further efforts in post-market testing and evaluation. As dis- cussed in Box 2-2, the CPSC is tasked with oversight of the safety of thousands of consumer products, including PPT for the general public. To conduct surveillance and post-marketing follow-up, CPSC has several data collection systems in place that allow consumers to report problems with unsafe products directly through an online reporting system (CPSC, 2010b) and that collect data on emergency room visits in which consum- er products are involved through the National Electronic Injury Surveil- lance System (CPSC, 2010c). These systems serve as examples of the potential for comparable efforts in occupational health surveillance and/or may be areas of collaboration in collecting worker safety informa- tion relevant to PPT. Committee Comments Only limited data exist on the performance of PPT in the workplace. Data are needed so that problems with PPT performance or use can be identified and resolved. The committee believes that stronger and more comprehensive efforts to collect and analyze health surveillance data are needed, particularly on PPT use in the workplace and adverse outcomes associated with the non-use of PPT, defective PPT, whether the PPT was certified or not, any issues with PPT misbranding or adulteration, and/or end-user issues with PPT.

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50 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES BOX 2-2 CPSC Product Safety Surveillance With an annual average of 23,000 deaths and more than 32.7 million injuries as- sociated with consumer products, the Consumer Product Safety Commission (CPSC) is responsible for regulating 15,000 consumer products to protect Ameri- cans from unreasonable risk of injury (CPSC, 2003). The CPSC is tasked with identifying hazards; developing and monitoring safety standards; compliance and enforcement; public outreach; and intergovernmental coordination (CPSC, 2009). In late 2007, toy manufacturers were required to recall millions of toys due to hazardous lead levels and unsafe toy components (Merle, 2007). The extensive toy recalls and increasing public concern surrounding toy safety led Congress to pass the Consumer Product Safety Improvement Act (Public Law 110-314) in August 2008. It included a mandate for third-party testing for certain children’s products. The wide scope of products under the purview of the CPSC has necessitated the development of a number of surveillance mechanisms, including the National Electronic Injury Surveillance System, which is in place in many hospital emer- gency rooms to transmit incident information regarding product-related events. Incident information can be transmitted electronically, in some cases within 24 hours after an occurrence. The CPSC also reviews mortality data in the form of approximately 8,700 death certificates annually covering unintentional product- related deaths. Consumers, manufacturers, healthcare professionals, and others can also report product problems directly through the CPSC website (CPSC, 2010b). NPPTL is currently exploring health surveillance opportunities rele- vant to PPT use. Several ongoing surveillance or data collection efforts could possibly be expanded to allow for collection of information on PPT and PPT use in the workplace, including NIOSH surveillance activi- ties such as the Fatality Assessment and Control Evaluation (FACE) pro- gram, health hazard evaluations, and the Sentinel Event Notification System for Occupational Risk (SENSOR). Health hazard evaluations conducted by NIOSH offer another opportunity for information on PPT use. For example, in 2008 a health hazard evaluation was conducted to evaluate potential hazards associated with repackaging of reflective glass beads; safety glasses were recommended to prevent eye injury (NIOSH, 2008). NIOSH also conducts follow-up investigations, including a recent evaluation of healthcare respirators in California (NIOSH, 2010b). More information on the extent and nature of PPT use in the workplace would inform improvements in both PPT products and their use.

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51 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT Workplace injury and illness reporting systems may be another po- tential source of information. Currently, the OSHA Injury and Illness Recordkeeping Standard (29 CFR §1904) mandates that injuries and ill- nesses are recorded on the OSHA 300 form, which gathers one to two lines of information on the injury. The OSHA forms are employer-based systems, which could be modified to collect data about PPT use, misuse, or failure. Additionally, the Bureau of Labor Statistics conducts an an- nual Survey of Occupational Injuries and Illnesses that requests informa- tion from a stratified sample of employers on injuries and illnesses listed on the OSHA 300 log. This survey could be another source for PPT in- formation if that data were required. OTHER GOVERNMENT ROLES Federal agencies are active in a number of other roles that facilitate and provide the foundation for conformity assessment efforts, including research, training, and convening roles. Additionally, as mentioned above, serving as an information clearinghouse to provide a reliable source of information on PPT selection, use, care, and maintenance is a critically important role. Research Federal agencies often play a vital role in conducting or funding re- search efforts that provide the foundation for test methodologies or that illuminate the criteria needed to assess a product’s effectiveness in real- world use. In part this may be research that is not of high interest to indi- vidual manufacturers, or the market niche may be so narrow for some types of PPT that federal agencies are best suited as funders. In addition to strengthening the conformity assessment process, these types of re- search are vital to protecting worker safety and health and are needed for reducing liability risk for purchasers and manufacturers. NPPTL has been active in research on test methods in a number of areas, including chemical permeation through protective clothing mate- rials. A partnership involving NPPTL, NIST, and North Carolina State University conducted interlaboratory testing and validation of the stored- energy test method; stored-energy testing is needed to avoid skin burns when wearing firefighter turnout gear. This ASTM standard will be con-

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52 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES sidered for incorporation into the next edition of NFPA 1971, Standard on Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting. As discussed in Chapter 4, research is needed on testing methods and standards criteria for protective ensembles and the interface among mul- tiple types of PPT (e.g., respirator, hearing protection, eye protection, protective helmet). Convening Role Another role for federal agencies is in convening the range of stake- holders involved in specific issues and promoting discussion among the groups. Currently, NPPTL holds an annual stakeholder meeting as well as a number of other public meetings to receive input on specific issues. Discussions with stakeholders, including end users, regarding conformity assessment for non-respirator PPT would be valuable. Training PPT effectiveness is highly dependent on the consistent provision of PPT by the employer and the correct use of PPT; therefore end-user edu- cation and training is critical. Consistent and performance-based training can have a large impact on the selection, use, care, and maintenance of PPT. OSHA has extensive requirements for the training of employees who use respirator protection (29 CFR §1910.134); similar efforts for non-respirator PPT training and certification of training personnel could be explored. REFERENCES AWI (Australian Wool Innovation Limited). 2010. Australian Wool Innovation Limited. http://www.wool.com (accessed August 10, 2010). Breitenberg, M. A. 1991. Laboratory accreditation activities in the United States, NISTIR 91-4576. http://gsi.nist.gov/global/docs/pubs/NISTIR_4576. 4576.pdf (accessed October 7, 2010). Breitenberg, M. A. 1997a. The ABCs of the U.S. conformity assessment system. NISTIR 6014. http://ts.nist.gov/Standards/Conformity/primer.cfm (accessed September 27, 2010).

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53 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT Breitenburg, M. A. 1997b. The U.S. certification system from a governmental perspective. NISTIR 6077. Gaithersburg, MD: National Institute of Stan- dards and Technology. CPSC (Consumer Product Safety Commission). 2003. CPSC strategic plan. http://www.cpsc.gov/cpscpub/pubs/reports/2003strategic.pdf (accessed May 14, 2010). CPSC. 2009. CPSC 2009 annual report. http://www.cpsc.gov/cpscpub/pubs/ reports/2009rpt.pdf (accessed May 17, 2010). CPSC. 2010a. CPSC registration for third-party testing laboratories user’s guide. http://www.cpsc.gov/about/cpsia/labreguserguide.pdf (accessed Sep- tember 28, 2010). CPSC. 2010b. Report unsafe products. http://www.cpsc.gov/talk.html (accessed October 1, 2010). CPSC. 2010c. National Electronic Injury Surveillance System. http://www.cpsc. gov/library/neiss.html (accessed October 1, 2010). DOJ (U.S. Department of Justice). 2010. Bulletproof vest partnership. http://www.ojp.usdoj.gov/bvpbasi/ (accessed May 4, 2010). EPA (Environmental Protection Agency). 2010. Clean Water Act enforcement. http://www.epa.gov/oecaerth/civil/cwa/index.html (accessed September 28, 2010). FCC (Federal Communications Commission). 2010. Equipment authorization. http://www.fcc.gov/oet/ea/procedures.html#sec2 (accessed October 4, 2010). GAO (U.S. General Accounting Office). 1994. Acquisition reform: DoD begins program to reform specifications and standards. GAO/NSIAD-95-14. Washington, DC: GAO. Gillerman, G. 2004. Making the confidence connection. ASTM International Standardization News. December. http://www.astm.org/SNEWS/DECEMBER _2004/gillerman_dec04.html (accessed August 9, 2010). IAB (InterAgency Board for Equipment Standardization and Interoperability). 2010. Standardized equipment list. https://iab.gov/SEL.aspx (accessed July 30, 2010). IOM and NRC (Institute of Medicine and National Research Council). 2008. The Personal Protective Technology Program at NIOSH. Washington, DC: The National Academies Press. ISO/IEC (International Organization for Standardization/International Electrotechnical Commission). 1996. General requirements for bodies operating product cer- tification systems. ISO/IEC Guide 65. ISO/IEC. 2004. Conformity assessment: Vocabulary and general principles. ISO/IEC 17000:2004. ISO/IEC. 2005. General requirements for the competence of testing and calibra- tion laboratories. ISO/IEC 17025. Merle, R. 2007. Mattel recalls more Chinese-made toys. The Washington Post, August 15.

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54 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES NIJ (National Institute of Justice). 2010. Models that comply with the NIJ standard-0101.06 for ballistic-resistance of body armor. http://www. justnet.org/pages/BallisticCPL.aspx (accessed May 19, 2010). NIOSH (National Institute for Occupational Safety and Health). 2008. Evalua- tion of employees’ chemical exposures while blending and repackaging glass beads for road markings. HETA 2008-0017-3095. http://www.cdc.gov/ niosh/hhe/reports/pdfs/2008-0017-3095.pdf (accessed August 9, 2010). NIOSH. 2010a. Respirator trusted-source information page. http://www.cdc. gov/niosh/npptl/topics/respirators/disp_part/RespSource.html (accessed July 30, 2010). 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 July 30, 2010). NIOSH. 2010c. NIOSH respirator user notices. http://www.cdc.gov/niosh/npptl/ usernotices (accessed August 17, 2010). NIOSH. 2010d. Certified equipment list. http://www.cdc.gov/niosh/npptl/topics/ respirator (accessed August 9, 2010). NIOSH. 2010e. Surveillance. http://www.cdc.gov/niosh/topics/surveillance (ac- cessed October 5, 2010). NIST (National Institute of Standards and Technology). 2010. National Voluntary Laboratory Accreditation Program. http://ts.nist.gov/standards/accreditation/ index.cfm (accessed September 28, 2010). OSHA (Occupational Safety and Health Administration). 2010a. OSHA forms for recording work-related injuries and illnesses. http://www.osha.gov/ recordkeeping/new-osha300form1-1-04.pdf (accessed September 28, 2010). OSHA. 2010b. Nationally recognized testing laboratories. http://www.osha. gov/dts/otpca/nrtl/index.html (accessed September 28, 2010). UL (Underwriters Laboratories). 2010. CTIA Battery Certification Program. http://www.ul.com/global/eng/pages/offerings/industries/hightech/batteries/ program/ (accessed August 4, 2010). USDA (U.S. Department of Agriculture). 2008. http://www.fsis.usda.gov/ Fact_Sheets/Slaughter_Inspection_101/index.asp (accessed August 10, 2010). USPTO (U.S. Patent and Trademark Office). 2010. Trademark manual of ex- amining procedure—6th ed., rev. 2: Service marks, collective marks, and certification marks. Washington, DC: USPTO. http://tess2.uspto.gov/tmdb/ tmep/1300.htm (accessed August 17, 2010).