Standards, Conformity Assessment, and Trade Into the 21st Century (1995) / Chapter Skim
Currently Skimming:
2 Standards Development
2 Standards Development
Pages 23-64
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 23... ...
The efforts of many U.S. voluntary consensus standards organizations, however, are coordinated by the private, nonprofit American National Standards Institute (ANSI)
|
From page 24... ...
Voluntary standards developed for private use often become mandatory when referenced within government regulation or procurement. Example: automobile crash protection-air bag and/or passive seat restraint mandated by National Highway and Traffic Safety Administration FIGURE 2-1 Types of standards.
|
From page 25... ...
Mandatory standards may cite voluntary standards in whole or in part, with or without additional criteria beyond those set in the referenced standard. For example, many of the regulations applied in state and local building codes require that electrical materials, such as wiring, meet portions of the National Electrical Code, a consensus standard developed by the private, nonprofit.National Fire Prevention Association.3 In addition, procurement specifications set by major manufacturers are, from the perspective of their suppliers, mandatory for doing business in the same way that government procurement standards are mandatory.
|
From page 26... ...
Remaining federal procurement and regulatory standards bring the total of U.S. government standards to 52,000.7 The number of private-sector, voluntary consensus standards in the United States is 41,500.8 Table 2-2 lists the 10 leading standards-developing organizations (SDOs)
|
From page 27... ...
14,500 Standards-Developing Membership Organizations Examples: American Society for Testing and Materials (ASTM) , National Fire Protection Association (NFPA)
|
From page 28... ...
Third, not all published standards have equal influence in the economy. Some voluntary standards fail to achieve widespread acceptance or use in the marketplace.
|
From page 29... ...
The absence of a formal, institutional process for designating de facto standards compounds the difficulty of identifying, much less quantifying, the output of de facto standards development efforts. These factors, among others, make it clear that neither a determination of the economic impact of standards activities in the United States nor an overall assessment of the U.S.
|
From page 30... ...
{7 Economic Rationale for Consensus Standardization These examples from the history of standardization illustrate one of the most important economic aspects of standards. Uncoordinated market mechanisms alone do not ensure that necessary standards are set.
|
From page 31... ...
A detailed body of recent economics literature examines the incentives facing firms to establish compatibility standards, such as telecommunication system interfaces and computer operating systems.22 These standards have unique economic properties, because they exhibit unusually strong returns to scale. Specifically, the more widespread a given network standard becomes, the greater does the incentive become for additional users to adopt that standard rather than be left as "orphans," incompatible with other systems.
|
From page 32... ...
In most cases, as noted above, uncoordinated market competition among firms promoting their own, proprietary solutions to particular market needs will not lead to as much standardization as is theoretically desirable for the economy as a whole. Voluntary consensus standards are an effective, rational response to this economic dilemma of standardization in the free market.
|
From page 33... ...
Prohibitively high payments to the owner of technology in a given standard, however, will deter its spread and motivate other parties to develop an alternative standard.27 In most consensus standards organizations, owners of intellectual property incorporated into a formal standard agree to license proprietary technology at reasonable terms.28 Voluntary Consensus Standardization Processes In comparison to most foreign systems, the institutional structure of the U.S. voluntary consensus standards system is highly decentralized.
|
From page 34... ...
There is ample opportunity for U.S. industry to participate in voluntary consensus standards development and ensure that it meets U.S.
|
From page 35... ...
Hydrolevel Corporation, a 1982 case in which a standards developer, ASME, was defeated in an antitrust suit. It was the actions of a committee interpreting product compliance with the ASME Boiler Code that was found to be anticompetitive not the code itself or the process by which it was written.37 The principles underlying consensus standards development evolved over a period of many years, within many different SDOs.
|
From page 36... ...
They represent a specialized category of organization responsible both for developing standards in certain sectors typically related to health and safety and for providing associated testing and certification ser vices.39 Professional Societies Professional societies are individual membership organizations that support the practice and advancement of a particular profession. Several such societies, particularly in the engineering disciplines, develop technical standards.
|
From page 37... ...
ASME is well known for its Boiler Code first published in 1914, and most recently revised and published as the Boiler and Pressure Vessel Code in 1992.42 Industry Associations Industry associations, also known as trade associations, are organizations of manufacturers, suppliers, customers, service providers, and other firms active in a given industry sector. Their mission is to further the interests of their industry sector, including the development of technical standards.
|
From page 38... ...
Established in 1898, ASTM is one of the world's largest voluntary consensus SDOs. It has an international membership of more than 35,000 and maintains 132 technical standards-writing committees.
|
From page 39... ...
voluntary consensus standards development system; to promote awareness and use of voluntary standards; and to represent U.S. interests in international standardization bodies.50 ANSI is a nonprofit organization with annual revenues in 1993 of $16.7 million.5i ANSI membership includes approximately 1,300 companies; 35 government agencies; and more than 260 technical, trade,- labor and consumer groups.52 ANSI's organizational structure is decentralized (see Figure 2-2~.
|
From page 40... ...
For example, more than half of the standards listed in the IEEE Standards Catalog are indicated, by footnote, as "recognized by the American National Standards Institute."55 The National Electrical Code, published by NFPA, is approved and identified by ANSI with the designation ANSI/NFPA 70; NFPA's own publications, however, refer to it simply as NFPA 70.56 Although ANSI is not a standards developer, as noted above, it publishes American National Standards developed by some of the groups it accredits. This activity has been a source of conflict between ANSI and some of the larger SDOs.
|
From page 41... ...
Of IEC Construc tion Standards Board Nuclear Standards Board Board of Standards Review Electrical and Electronic Standards Board Safety and Health Standards Board Accredit ation Comm. Image Techno logy Standards Board SOURCE: American National Standards Institute.
|
From page 44... ...
These are standards that describe technologies and products not yet completely developed. Recent economics research, moreover, suggests that setting compatibility standards for rapidly evolving information and telecommunications technologies presents a unique challenge to consensus standards developers.
|
From page 45... ...
The limited due process, consensus, and open participation requirements of these organizations enable them to develop standards rapidly in many instances. Their procedures and restricted membership, however, may limit the acceptability of these standards outside the consortia that develop them.64 Consensus standards developers are responding to this challenge with such measures as streamlined due process and a tighter focus on customer needs in setting the scope for standards writing.
|
From page 46... ...
private SDOs in many respects.69 ISO and IEC prepare standards within a decentralized technical committee structure, drawing on volunteer technical experts from various member countries. Administrative support for technical committees is provided by a secretariat, from one of the participating countries.
|
From page 47... ...
In addition, standards produced by some U.S. standards developers take on the authority of international standards without going through a process of consensus building at ISO and IEC.
|
From page 48... ...
Although these standards are developed outside the ANSI-coordinated voluntary consensus system, the mandatory and voluntary standards categories overlap. Many government standards
|
From page 49... ...
Examples include regulations set by the Food and Drug Administration, Occupational Safety and Health Administration (OSHA) , Consumer Product Safety Commission (CPSC)
|
From page 50... ...
Patent and Trademark Office Assistant Commissioner for Information Systems Assistant Commissioner for Patents International Patent Documentation Trademark Examining Operation Consumer Product Safety Commission Directorate for Engineering Sciences Directorate for Health Sciences Defense, Department of Office of the Assistant Secretary of Defense, Acquisition Defense Industrial Supply Center Energy, Department of Assistant Secretary for Defense Programs Building Technologies Building Systems and Materials Division Building Equipment Division Energy Information Administration Statistical Standards Environment, Safety, and Health Safety and Quality Assurance Environmental Protection Agency Federal Communications Commission Office of Engineering and Technology General Services Administration Information Resources Management Federal Supply Service Commodity Management Public Building Service Health and Human Services, Department of Centers for Disease Control National Institute for Occupational Safety and Health Food and Drug Administration Regulatory Affairs Health Care Financing Administration Housing and Urban Development, Department of Assistant Secretary for Housing - Federal Housing Commissioner Manufactured Housing and Construction Standards Division Interior, Department of the Minerals Management Service Rules, Orders, and Standards U.S. Geological Survey Information Systems Division National Mapping Division Water Resources Division Labor, Department of Mine Safety and Health Administration Standards, Regulations and Variances Occupational Safety and Health Administration Directorate of Safety Standards Programs National Aeronautics and Space Administration Occupational Health Safety, Reliability, Maintainability, and Quality Assurance Division National Archives and Records Administration Archival Research and Evaluation Staff Nuclear Regulatory Commission Nuclear Regulatory Research
|
From page 51... ...
These levels of government are very active in the areas of product certification and laboratory accreditation. Such programs, however, largely make assessments against standards originally written by other authorities for example, private building codes organizations for construction standards and the NFPA's ANSI-approved National Electrical Code.78 (The automobile emissions standards written by the State of California are a well-known exception.)
|
From page 52... ...
Appropriations for intramural programs, consisting primarily of the eight NIST laboratories, grew from $226.2 million to $316.0 million. The Office of Standards Services which leads NIST's interactions with the voluntary consensus standards community and other federal agencies with standards activities- is part of NIST's Technology Assistance activity.
|
From page 53... ...
Department of Commerce, 1 994. 53 participation in domestic and international standards committees, at a total cost of more than $1 million.85 Compilation of data on NIST staff's participation in consensus standards setting is one among several functions of the Office of Standards Services.
|
From page 54... ...
Federal Use of Voluntary Consensus Standards Many federal agencies besides NIST are active in developing and using standards. Procurement standards set by the DoD and the GSA together represent the majority of federal standards.
|
From page 55... ...
Increasingly, however, government agencies are meeting their statutory obligations not by developing government-unique standards but, rather, by participating in and adopting the end products of voluntary consensus standards development. In 1982, the Office of Management and Budget (OMB)
|
From page 56... ...
With the exception of especially hazardous product sectors such as drugs, moreover, agencies have generally been far more effective at influencing corporate design and production of safe products through public information campaigns, including product advisories, and product recalls than through the writing of mandatory standards.96 Second, voluntary consensus standards are often equally as stringent in the level of protection they require as mandatory standards would be.97 It might seem reasonable to expect that private standards developers- industry associations, especially would seek to set standards at the lowest common denominator of safety. Such standards might allow manufacturers to cut costs, for example.
|
From page 57... ...
has a mandate to coordinate policy throughout the federal government on using voluntary consensus standards. In 1987, because of a lack of commitment on the part of regulatory agencies, ICSP was virtually disbanded.99 The OMB's 1993 revision of the circular required each agency to appoint an senior Standard Executive to serve on the ICSP, and it raised the frequency of required reports on agency activities in voluntary standardization from triennial to annual.~°° The ICSP was rechartered in June 1991 and has begun meeting approximately annually.
|
From page 58... ...
Chief Financial Officer Director, Office of Nuclear Safety Policy and Standards Deputy Director, Office of Modeling, Monitoring Systems and Quality Assurance Chief Engineer Deputy Associate Director, Operations Support Directorate Associate Director for the Bureau of Consumer Protection Deputy Assistant Commissioner, Office of Commodity Management, Federal Supply Service Manager, Quality Control and Technical Department Director, Office of Standards and Regulations, Center for Devices and Radiological Health Senior Advisor for Science, Technology and Urban Policy Director, Office of Acquisition and Property Management Director, Office of Administration Director, Office of Policy Development Assistant Secretary for Administration and Management Associate Administrator for Safety and Mission Assurance Preservation Officer Consumer Affairs, Office of Consumer Product Safety Commission Defense, Department of Education, Department of Energy, Department of Environmental Protection Agency Federal Communications Commission Federal Emergency Management Agency Federal Trade Commission General Services Administration Government Printing Office, U.S. Health and Human Services, Department of - Food and Drug Administration Housing and Urban Development, Department of Interior, Department of the International Trade Commission Justice, Department of Labor, Department of National Aeronautics and Space Administration National Archives and Records Administration
|
From page 59... ...
An MOU would, however, facilitate understanding throughout the government of the potential uses of voluntary standardization in meeting public objectives. It would recognize the system of voluntary consensus standardization, conducted by SDOs with coordination and accreditation by ANSI, as a valuable source of standards for public use.
|
From page 60... ...
positions for international standards activities.~°5 An MOU would also be an appropriate vehicle for addressing a frequent source of tension in public-private standards cooperation. This source is the low level of government financial support for voluntary standards organizations, including ANSI.
|
From page 61... ...
Government agencies set mandatory standards, both to meet regulatory needs in areas such as health and safety and to support public-sector procurement of products and services. Voluntary standards developed in the private sector may become mandatory through adoption as government standards.
|
From page 62... ...
39. Cheit, Setting Safety Standards, 23-25; and OTA, Global Standards, 49-51.
|
From page 63... ...
ANSI, The U.S. Voluntary Standardization System, 30; and Michael Miller, President, Association for the Advancement of Medical Instrumentation, presentation to the Conference on New Developments in International Standards and Global Trade.
|
From page 64... ...
expenses, primarily administration of U.S. consensus standards development.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.