Certifying Personal Protective Technologies Improving Worker Safety (2011) / Chapter Skim
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2 Role of Government Agencies in Conformity Assessment
2 Role of Government Agencies in Conformity Assessment
Pages 33-54
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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.
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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.
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Voluntary Consensus Standards Voluntary consensus standards for the manufacturing, performance, and testing of products are developed by national and international standards development organizations. These organizations work through expert committees consisting of representatives from government agencies, manufacturers, employers, academia, and end users.
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National Personal Protective Technology Laboratory (NPPTL) staff members actively participate in voluntary standards development by serving on a number of standards committees for ASTM, ANSI, ISO, and NFPA (Box 2-1)
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In general, the voluntary standards organization has no vested interest 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)
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The FDA's process for approving medical devices incorporates voluntary consensus standards into FDA guidance documents. Similarly, the National Institute of Justice (NIJ)
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The National Technology Transfer and Advancement Act (Public Law 104-113) encourages federal government agencies to be involved in relevant voluntary consensus standards development.
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Valid product testing follows specific testing methodologies outlined in the standards or in other approved documents. Independent testing laboratories can be private, public, nonprofit, or forprofit.
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. Committee Comments Independent testing by accredited third-party laboratories and certifying 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.
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The Consumer 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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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?
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. 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 products meet the requisite standards.
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For example, OSHA regulations for protective helmets used in the workplace require that the products meet a specific standard, but third-party certification is not required. Voluntary third-party certification is available from several private-sector testing and certifying organizations.
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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)
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Committee Comments Communication about certified products is a valuable role for government 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 nonrespirator PPT products that meet the required standards or other regulations.
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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 assessment processes to ensure that those standards are being met.
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and that collect data on emergency room visits in which consumer products are involved through the National Electronic Injury Surveillance System (CPSC, 2010c)
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. 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)
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In addition to strengthening the conformity assessment process, these types of research 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 materials.
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2010. Australian Wool Innovation Limited.
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2008. The Personal Protective Technology Program at NIOSH.
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2010. National Voluntary Laboratory Accreditation Program.
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