MODERN DISEASE PREVENTION
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A consensus means that everyone agrees to say collectively what no one believes individually. 
— Aubrey Solomon Meir "Abba" Eban (1915-2002)

A CRITIQUE OF THE CONSENSUS PROCESS IN STANDARD DEVELOPMENT
“As long as the little light on top is green, the water meets ASTM Type I standards...”
     In the mid seventeenth century, Galileo was struggling with a consensus standard when he said, “In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual.” Galileo’s words transcend the centuries – the consensus process will always be fundamentally political, not scientific.
     An unscientific or technically unsound standard does not get better as it gains wider acceptance, it simply becomes more destructive. American Society for Testing and Materials (ASTM) International’s D1193 – Standard Specification for Reagent Water is a classic example of just such a situation. ASTM D1193 appears to be a surprisingly vague, poorly edited, error-filled, and internally inconsistent process specification (not a reagent water product specification), which does not require any monitoring or maintenance of the specified purification systems.
     This critique of ASTM D1193 has been evolving with input from many interested parties since January of 1998 and its purpose is to serve as a banner around which the loyal opposition to D1193 can rally their forces in order to bring about a change. This... places D1193 in perspective, explains why it is so important for anyone who uses reagent-grade water to become familiar with the issues, and suggests how a scientifically and technically sound alternative standard might be developed.
     The significance of reagent-grade water — Reagent-grade water is absolutely essential to laboratories engaged in researching and testing biological systems (this includes medical laboratories), which represent the large majority of laboratories in general. Of all the purified chemicals used by laboratories, reagent-grade water is among the most difficult to purify and the most likely to be used in concentrated form (as a solvent).
     Traces of contamination in reagent-grade water are a much greater problem than traces of contamination in a reagent-grade salt, which would typically be diluted many times. Much of what laboratories study and measure can be significantly affected by trace levels of contaminants in reagent-grade water. And if laboratories cannot trust the consistency and purity of their reagent-grade water, can they trust their results.
     How pure is reagent-grade water? — Potable tap water is pretreated to make it acceptable for human consumption. But compared to reagent-grade water, tap water remains a veritable soup of contaminants. The purity of reagent-grade water will depend heavily on the efficiency of subsequent stages of purification. Salts are the easy part. Purification systems must also cope with microorganisms and an inconceivable array of organics, produced naturally and as the result of human activity (including pharmaceuticals).
     The challenge for laboratories is to select effective systems, or components, and apply them to their best advantage with effective monitoring. But standards impact the choices laboratories make, directly and indirectly. Standards affect the availability and market share of commercial water purification systems and components. Standards influence what laboratories are told and learn about water purification technologies. And standards dictate how laboratories report reagent-grade water purity.
     So how pure is reagent-grade water? The honest answer is that poor standards have made it impossible to even guess. All that can be said with certainty is that reagent-grade water is not nearly as pure as it could be with greater awareness and very little effort.
     In perspective — D1193 has been ASTM International’s only reagent water specification for nearly 50 years, and it is the most widely cited specification for reagent water in the world. Informal surveys suggest that a majority of scientists believe Type I water, a term coined by D1193, to be the accepted standard of water purity for nearly every discipline. Most laboratory water purification systems have probably been purchased on the basis of Type I claims. However, as this critique will make clear, there is a gulf between the perception of D1193 and its reality.
Erich L. Gibbs, PhD. A Critique of ASTM Standard D1193, 1999, Specification for Reagent Water, American Society for Testing and Materials. International 2001 Annual Book of Standards – Volume 11.01, Edition 2.6. Nov 2003. http://www.high-q.com/pdf/astm_d1193_critique.pdf
DECISION-MAKING: CONSENSUS vs. GROUPTHINK
     Teams seek consensus in decisions. However, this does not mean that the decision is the first choice of all members. Rather, the decision is acceptable enough to all members that they can support it and the decision is not opposed by any member.
     Groupthink occurs when strong influences are at work to conform to the group and suppress individual views. Consensus is not the same as groupthink.
Daut, Kathryn. Groupthink--The Dark Side of Teaming and How to Counteract It! U.S. Air Force, Air War College, Leadership, Ethics, & Command Central, Communication Skills, Mediation and Facilitation.
CONSENSUS, OPENNESS AND TRANSPARENCY
     The American National Standards Institute (ANSI) is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. Comprised of nearly 1,000 businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations, ANSI represents the diverse interests of more than 120,000 entities and 3.2 million professionals worldwide.
     The United States Standards Strategy (USSS) was published by ANSI in December 2005. It establishes a framework that can be used by all interested parties to further advance trade issues in the global marketplace, enhance consumer health and safety, meet stakeholder needs and, as appropriate, advance U.S. viewpoints in the regional and international arena. The USSS is a revision of the National Standards Strategy for the United States (NSS) that was approved in August 2000.
     The first NSS reaffirmed that the U.S. is committed to a sector-based approach to voluntary standardization activities, both domestically and globally. It established a standardization framework that was built upon the traditional strengths of the U.S. system — such as consensus, openness and transparency — while giving additional emphasis to speed, relevance, and meeting the needs of public interest constituencies. Strategic and tactical initiatives contained within this framework were developed so that they could then be used by diverse interests to meet their own national and individual organizational objectives.
     As called for in the first NSS, ANSI tracked implementation efforts and provided a mechanism for coordinating, integrating, and reporting progress. In early 2004, the Institute convened the United States Standards Strategy Committee to determine whether the NSS needed to be revised to reflect current issues and anticipated trends; several subgroups were created for the purpose of advancing particular aspects of the project. Participation in the subgroups was open to all interested parties from the United States.
     The ANSI Federation is made up of nearly 1,000 U.S. businesses, professional societies and trade associations, standards developers, government agencies, institutes and consumer and labor interests, all working together to develop voluntary national consensus standards.
     Since it was founded in 1918, ANSI’s strength has been in the diversity and expertise of its membership, which includes representation from almost every U.S. industry sector. ANSI coordinates the U.S. voluntary consensus standards system, providing a neutral forum for the development of policies on standards issues and serves as a watchdog for standards development and conformity assessment programs and processes.
     Approval of the National Technology Transfer and Advancement Act (P.L. 104-113) in the mid-1990’s also helped to encourage federal agencies to rely upon and participate in the voluntary standards and conformity assessment systems. Congress’s 1996 passage of the National Technology Transfer and Advancement Act requires federal agencies to increase their reliance upon—and participation in—the voluntary consensus standards and conformity assessment systems.
     In addition, the National Institute for Standards and Technology (NIST), an agency of the U.S. Department of Commerce, has officially recognized ANSI’s role as the official U.S. representative to the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) via the U.S. National Committee (USNC), and many regional standards organizations.
UNITED STATES STANDARDS STRATEGY. American National Standards Institute.
http://www.ansi.org/standards_activities/nss/usss.aspx
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