Global Harmonization of Safety Standards Examining the European Influence on the Practice of Safety by Fred A
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Manuele Feature Nov 2005.qxd 10/14/2005 8:21 AM Page 41 StandardsStandards Global Harmonization of Safety Standards Examining the European influence on the practice of safety By Fred A. Manuele “ALMOST 99 PERCENT OF dards regulation will come from the impacts AEuropean Union over time.” Those are the U.S.-based organ- words of Jeffrey Immelt, CEO of General Electric, izations and extends the as quoted in the April 23, 2002, issue of the Wall Street knowledge needs of SH&E professionals. Journal (Mitchener). A safety director of a Fortune 100 Based on the author’s evaluations and the com- entity recently said that his company had more lobby- mittee work now in progress related to European ists in Brussels, Belgium, than it did in Washington. safety standards and guidelines, the following pre- According to Michael Taubitz, whose safety re- dictions are offered. sponsibilities at General Motors are global, on 1) The concept of safety through design will be policy-level issues, the Europeans have the organiza- moved forward by the adoption of ANSI standards tions in place to bring together all stakeholders—gov- containing provisions which will require equipment ernment, employers, labor, suppliers, consumers and manufacturers to document that hazards other interest groups. They also have developed have been identified and analyzed, and Fred A. Manuele, P.E., CSP, is processes through which these stakeholders can reach that risks have been reduced to an accept- president of Hazards Limited, agreement on and issue standards and guidelines. able level. which he formed after retiring These statements prompted an inquiry to deter- 2) It will become commonplace for from Marsh & McLennan, where mine the extent to which standards and guidelines equipment purchasers to develop de- he was managing director and developed in Europe have affected the practice of tailed specifications for inherently safer manager of M&M Protection safety and quality management in the U.S. and designs to be implemented by design and Consultants. Manuele is an ASSE throughout the world, and how they may have an engineering personnel in organizations Fellow, an inductee into the additional influence in the future. that supply machinery and equipment. Safety and Health Hall of Fame 3) Provisions requiring hazard identifi- International and a recipient of The Path of Globalization cation and analysis, risk assessment and National Safety Council’s (NSC) Global harmonization of safety, quality and envi- risk reduction will be included in stan- Distinguished Service to Safety ronmental standards has progressed considerably. dards pertaining to occupational safety Award. He is also a former board Prudent SH&E professionals must be aware of and health management systems, and member of ASSE, Board of Certified developments with respect to those standards and SH&E professionals will become skilled Safety Professionals and NSC, and a guidelines as they influence the expanding knowl- in those fields. former member of ASSE’s Editorial edge needs in the practice of safety. Several exam- 4) The value of including management Review Board. Manuele is a ples are cited here to illustrate how European of change (as now contained in OSHA’s professional member of ASSE’s activity on safety, quality and environmental stan- Process Safety Management standard) as Northeastern Illinois Chapter. www.asse.org NOVEMBER 2005 PROFESSIONAL SAFETY 41 Manuele Feature Nov 2005.qxd 10/14/2005 8:21 AM Page 42 an element in all safety and health management sys- passing standard with broad application. ISO 14121 tems will be recognized. provides guidance with respect to the risk assess- 5) As is the case in quality and environmental man- ment provisions in ISO 12100-1. These excerpts are agement, certified personnel independent of the em- from the scope of ISO 14121. ployer will make accreditation audits of occupational This international standard gives guidance on safety and health management systems. the information required to allow risk assess- Safety in the Design Process ments to be carried out. Procedures are de- The central secretariat for the European Committee scribed for identifying hazards and estimating for Standardization is based in Brussels. It has attained and evaluating risk. The purpose of the inter- consensus on many standards that member countries national standard is to provide advice for deci- in the European Union (EU) are to apply. Three of sions to be made on the safety of machinery those standards related to occupational safety and and the type of documentation required to health have had considerable impact on manufactur- verify the risk assessment carried out. ers worldwide: Under the heading “Strategy for Risk Reduction,” •European standard EN 292-1, Safety of ISO 12100-1 states that the designer shall take the fol- Machinery—Basic Concepts, General Principles for lowing actions—in this order: Design. Part 1: Basic Terminology, Methodology. (EN •specify the machine’s limits; stands for European Norm.) •identify the hazards and associated hazardous •EN 292-2, Technical Principles. situations; These standards were issued in 1991. EN 292-1 •estimate the risk for each identified hazard and required that designers of workplace machinery and hazardous situation; equipment perform risk assessments and reduce the •evaluate the risk and make decisions about the risks to tolerable levels. Since guidance was needed need for risk reduction; concerning what was expected in risk assessment, a •eliminate the hazard or reduce the risk associat- third standard was issued in 1997—EN 1050, Safety ed with the hazards by protective measures. of Machinery: Principles of Risk Assessment. Under the same heading, one finds extensive pro- These three standards have been adopted—with visions for hazard identification, risk estimation and some modifications—as international standards by the risk evaluation; hazard elimination or reduction via International Organization for Standardization (ISO). protective measures; and achievement of risk reduc- EN 1050 was adopted as ISO 14121 in 1999. EN 292 tion objectives. ISO 14121 (Safety of Machinery: Prin- parts 1 and 2 became ISO 12100-1 and ISO 12100-2 ciples of Risk Assessment) sets forth a hazard in 2003. Titles of the standards remained the same. identification and risk assessment methodology. ISO is the world’s largest nongovernmental devel- All machinery and equipment that meets the defi- oper of standards, working with a network of the nition of a machine in ISO 12100-1 which is exported national standards institutes of 148 countries. The U.S. to EU countries by American companies must meet is represented at ISO by ANSI. A central secretariat the requirements of these standards. That trade based in Geneva, Switzerland, coordinates the system. encompasses many billions of dollars. To illustrate the An early stated purpose of ISO was “to facilitate extent of the impact of those standards, following is a the international coordination and unification of review of actions taken by the ANSI committees industrial standards.” Since its formation in 1947, responsible for standards pertaining to machine tools. ISO has issued more than 13,700 international stan- dards. Although ISO standards are voluntary, coun- tries have adopted them as part of their regulatory B11.TR3 and administrative framework—particularly quali- ANSI’s B11 Accredited Standards Committee ty, safety and health, and environmental standards. (ASC) on Machine Tool Safety Standards formed a As of 1997, most of the machinery and equipment subcommittee to develop a technical report (TR) to to be used in workplaces throughout the EU must provide guidance on the application of risk assess- bear a Compliance European (CE) mark. To obtain ment principles for machine tool manufacturers and this mark, a “responsible person” (most often the users. The committee’s report (B11.TR3) is titled manufacturer) must ensure that certain documenta- “Risk Assessment and Reduction: A Guideline to tion concerning the product’s safety is available for Estimate, Evaluate and Reduce Risks Associated inspection by enforcement authorities. By affixing with Machine Tools.” TR3 became a registered ANSI the CE mark, a manufacturer indicates that the prod- document in November 2000. One guiding principle uct complies with all applicable directives in adopted by the committee was to produce a techni- force—including the risk assessment and risk reduc- cal report that to the extent possible was harmonized tion provisions initially stated in EN 292-1 and with European standards. included (with revisions) in ISO 12100-1. The CE B11.TR3 is a guideline for the committees respon- mark is the passport for goods entering EU countries. sible for the 24 machine tool standards administered The provisions stated in ISO 12100-1 are intended by the B11 ASC. To date, revisions made in about 75 for the designer. The standard defines the basic ter- percent of those standards incorporate the risk minology and methodology designers are to use to assessment concepts set forth in TR3. Similar revi- achieve safety of machinery. It is a generic, all-encom- sions are in progress for the remaining 25 percent. 42 PROFESSIONAL SAFETY NOVEMBER 2005 www.asse.org Manuele Feature Nov 2005.qxd 10/14/2005 8:21 AM Page 43 Current Activity in the U.S. duced as the principal methods to be used to achieve Related to European Standards acceptable risk levels for personnel. Minutes of the January 2005 meeting of the B11 Another significant standard that will have ASC include this paragraph. impact on the content of the practice of safety is ANSI The B11 ASC reiterates its intent to pursue Z10, Occupational Health and Safety Management adoption of the ISO standards 12100-1 and -2 Systems. Approved in late July 2005, this standard (concerning general requirements for safety of was also influenced by European standards. The machinery, including risk reduction) and scope of Z10 is to develop a standard of management 14121 (concerning risk assessment).