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A01 STEEL, STAINLESS STEEL AND RELATED ALLOYS A04 IRON CASTINGS A05 METALLIC-COATED IRON AND STEEL PRODUCTS B01 ELECTRICAL CONDUCTORS B05 COPPER AND COPPER ALLOYS B07 LIGHT METALS AND ALLOYS C01 CEMENT C04 VITRIFIED CLAY PIPE C07 LIME AND LIMESTONE C09 CONCRETE AND CONCRETE AGGREGATES C11 GYPSUM AND RELATED BUILDING MATERIALS AND SYSTEMS C12 MORTARS AND GROUTS FOR UNIT MASONRY C13 CONCRETE PIPE C14 GLASS AND GLASS PRODUCTS C15 MANUFACTURED MASONRY UNITS C16 THERMAL INSULATION C17 FIBER-REINFORCED CEMENT PRODUCTS C18 DIMENSION STONE C21 CERAMIC WHITEWARES AND RELATED PRODUCTS C24 BUILDING SEALS AND SEALANTS C27 PRECAST CONCRETE PRODUCTS D01 PAINT AND RELATED COATINGS, MATERIALS, AND APPLICATIONS D04 ROAD AND PAVING MATERIALS D07 WOOD D08 ROOFING AND WATERPROOFING D09 ELECTRICAL AND ELECTRONIC INSULATING MATERIALS D11 RUBBER D14 ADHESIVES D18 SOIL AND ROCK D20 PLASTICS D35 GEOSYNTHETICS E05 FIRE STANDARDS E06 PERFORMANCE OF BUILDINGS E33 BUILDING AND ENVIRONMENTAL ACOUSTICS E36 ACCREDITATION & CERTIFICATION E57 3D IMAGING SYSTEMS E60 SUSTAINABILITY F01 ELECTRONICS F06 RESILIENT FLOOR COVERINGS F13 PEDESTRIAN/WALKWAY SAFETY AND FOOTWEAR F16 FASTENERS F17 PLASTIC PIPING SYSTEMS F33 DETENTION AND CORRECTIONAL FACILITIES F36 TECHNOLOGY AND UNDERGROUND UTILITIES G03 WEATHERING AND DURABILITY C14 GLASS AND GLASS PRODUCTS C21 CERAMIC WHITEWARES AND RELATED PRODUCTS D01 PAINT AND RELATED COATINGS, MATERIALS, AND APPLICATIONS D06 D09 ELECTRICAL AND ELECTRONIC INSULATING MATERIALS D10 PACKAGING D11 RUBBER D12 SOAPS AND OTHER DETERGENTS D13 TEXTILES D14 ADHESIVES D15 ENGINE COOLANTS AND RELATED FLUIDS D20 PLASTICS D21 POLISHES D31 LEATHER E12 COLOR AND APPEARANCE E18 SENSORY EVALUATION E20 TEMPERATURE MEASUREMENT E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E41 LABORATORY APPARATUS E53 ASSET MANAGEMENT E57 3D IMAGING SYSTEMS F02 FLEXIBLE BARRIER PACKAGING F05 BUSINESS IMAGING PRODUCTS F06 RESILIENT FLOOR COVERINGS F08 SPORTS EQUIPMENT, PLAYING SURFACES, AND FACILITIES F09 TIRES F10 LIVESTOCK, MEAT, AND POULTRY EVALUATION SYSTEMS F11 VACUUM CLEANERS F13 PEDESTRIAN/WALKWAY SAFETY AND FOOTWEAR F14 FENCES F15 CONSUMER PRODUCTS F16 FASTENERS F24 AMUSEMENT RIDES AND DEVICES F26 FOOD SERVICE EQUIPMENT F27 SNOW SKIING F37 LIGHT SPORT AIRCRAFT F43 LANGUAGE SERVICES AND PRODUCTS F44 GENERAL AVIATION AIRCRAFT A01 STEEL, STAINLESS STEEL AND RELATED ALLOYS A04 IRON CASTINGS A05 METALLIC-COATED IRON AND STEEL PRODUCTS A06 MAGNETIC PROPERTIES B01 ELECTRICAL CONDUCTORS B02 NONFERROUS METALS AND ALLOYS B05 COPPER AND COPPER ALLOYS B07 LIGHT METALS AND ALLOYS B08 METALLIC AND INORGANIC COATINGS B09 METAL POWDERS AND METAL POWDER PRODUCTS B10 REACTIVE AND REFRACTORY METALS AND ALLOYS C03 CHEMICAL-RESISTANT NONMETALLIC MATERIALS C08 REFRACTORIES C28 ADVANCED CERAMICS D01 PAINT AND RELATED COATINGS, MATERIALS, AND APPLICATIONS D20 PLASTICS D30 COMPOSITE MATERIALS E01 ANALYTICAL CHEMISTRY FOR METALS, ORES, AND RELATED MATERIALS E04 METALLOGRAPHY E07 NONDESTRUCTIVE TESTING E08 FATIGUE AND FRACTURE E12 COLOR AND APPEARANCE E13 MOLECULAR SPECTROSCOPY AND SEPARATION SCIENCE E28 MECHANICAL TESTING E29 PARTICLE AND SPRAY CHARACTERIZATION E37 THERMAL MEASUREMENTS E42 SURFACE ANALYSIS F01 ELECTRONICS F34 ROLLING ELEMENT BEARINGS F40 DECLARABLE SUBSTANCES IN MATERIALS F42 ADDITIVE MANUFACTURING TECHNOLOGIES G01 CORROSION OF METALS G03 WEATHERING AND DURABILITY D21 POLISHES D26 HALOGENATED ORGANIC SOLVENTS AND FIRE EXTINGUISHING AGENTS D33 PROTECTIVE COATING AND LINING WORK FOR POWER GENERATION FACILITIES E05 FIRE STANDARDS E27 HAZARD POTENTIAL OF CHEMICALS E30 FORENSIC SCIENCES E34 OCCUPATIONAL HEALTH AND SAFETY E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E52 FORENSIC PSYCHOPHYSIOLOGY E54 HOMELAND SECURITY APPLICATIONS E58 FORENSIC ENGINEERING F06 RESILIENT FLOOR COVERINGS F08 SPORTS EQUIPMENT, PLAYING SURFACES, AND FACILITIES F10 LIVESTOCK, MEAT, AND POULTRY EVALUATION SYSTEMS F12 SECURITY SYSTEMS AND EQUIPMENT F13 PEDESTRIAN/WALKWAY SAFETY AND FOOTWEAR F15 CONSUMER PRODUCTS F18 ELECTRICAL PROTECTIVE EQUIPMENT FOR WORKERS F23 PERSONAL PROTECTIVE CLOTHING AND EQUIPMENT F26 FOOD SERVICE EQUIPMENT F32 SEARCH AND RESCUE F33 DETENTION AND CORRECTIONAL FACILITIES G04 COMPATIBILITY AND SENSITIVITY OF MATERIALS IN OXYGEN ENRICHED ATMOSPHERES D08 ROOFING AND WATERPROOFING D18 SOIL AND ROCK D19 WATER D20 PLASTICS D22 AIR QUALITY D34 WASTE MANAGEMENT D35 GEOSYNTHETICS E06 PERFORMANCE OF BUILDINGS E44 SOLAR, GEOTHERMAL AND OTHER ALTERNATIVE ENERGY SOURCES E47 E48 BIOENERGY AND INDUSTRIAL CHEMICALS FROM BIOMASS E50 ENVIRONMENTAL ASSESSMENT, RISK MANAGEMENT AND CORRECTIVE ACTION E60 SUSTAINABILITY F20 HAZARDOUS SUBSTANCES AND OIL SPILL RESPONSE F40 DECLARABLE SUBSTANCES IN MATERIALS G02 WEAR AND EROSION B01 ELECTRICAL CONDUCTORS C26 NUCLEAR FUEL CYCLE D02 PETROLEUM PRODUCTS, LIQUID FUELS, AND LUBRICANTS D03 GASEOUS FUELS D05 COAL AND COKE D19 WATER D27 ELECTRICAL INSULATING LIQUIDS AND GASES D33 PROTECTIVE COATING AND LINING WORK FOR POWER GENERATION FACILITIES E10 NUCLEAR TECHNOLOGY AND APPLICATIONS E44 SOLAR, GEOTHERMAL AND OTHER ALTERNATIVE ENERGY SOURCES E48 BIOENERGY AND INDUSTRIAL CHEMICALS FROM BIOMASS A01 STEEL, STAINLESS STEEL AND RELATED ALLOYS C01 CEMENT C09 CONCRETE AND CONCRETE AGGREGATES D02 PETROLEUM PRODUCTS, LIQUID FUELS, AND LUBRICANTS D03 GASEOUS FUELS D04 ROAD AND PAVING MATERIALS D15 ENGINE COOLANTS AND RELATED FLUIDS D18 SOIL AND ROCK D24 CARBON BLACK D35 GEOSYNTHETICS E12 COLOR AND APPEARANCE E17 VEHICLE - PAVEMENT SYSTEMS E21 SPACE SIMULATION AND APPLICATIONS OF SPACE TECHNOLOGY E36 ACCREDITATION & CERTIFICATION E57 3D IMAGING SYSTEMS F03 GASKETS F07 AEROSPACE AND AIRCRAFT F09 TIRES F16 FASTENERS F25 SHIPS AND MARINE TECHNOLOGY F37 LIGHT SPORT AIRCRAFT F38 UNMANNED AIRCRAFT SYSTEMS F39 AIRCRAFT SYSTEMS F41 UNMANNED MARITIME VEHICLE SYSTEMS (UMVS) F44 GENERAL AVIATION AIRCRAFT F45 DRIVERLESS AUTOMATIC GUIDED INDUSTRIAL VEHICLES D10 PACKAGING D11 RUBBER E31 HEALTHCARE INFORMATICS E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E54 HOMELAND SECURITY APPLICATIONS E55 MANUFACTURE OF PHARMACEUTICAL PRODUCTS E56 NANOTECHNOLOGY F02 FLEXIBLE BARRIER PACKAGING F04 MEDICAL AND SURGICAL MATERIALS AND DEVICES F29 ANESTHETIC AND RESPIRATORY EQUIPMENT F30 EMERGENCY MEDICAL SERVICES G04 COMPATIBILITY AND SENSITIVITY OF MATERIALS IN OXYGEN ENRICHED ATMOSPHERES C07 LIME AND LIMESTONE D14 ADHESIVES D16 AROMATIC HYDROCARBONS AND RELATED CHEMICALS D20 PLASTICS D26 HALOGENATED ORGANIC SOLVENTS AND FIRE EXTINGUISHING AGENTS D28 ACTIVATED CARBON D32 CATALYSTS E13 MOLECULAR SPECTROSCOPY AND SEPARATION SCIENCE E15 INDUSTRIAL AND SPECIALTY CHEMICALS E27 HAZARD POTENTIAL OF CHEMICALS E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS F40 DECLARABLE SUBSTANCES IN MATERIALS E11 QUALITY AND STATISTICS E36 ACCREDITATION & CERTIFICATION E43 SI PRACTICE E55 MANUFACTURE OF PHARMACEUTICAL PRODUCTS E56 NANOTECHNOLOGY F42 ADDITIVE MANUFACTURING TECHNOLOGIES
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Features

Features

The Accreditation Advantage

U.S. Federal Agencies Benefit from Accredited Laboratories

Accreditation is the independent evaluation of conformity assessment bodies against recognized standards to carry out specific activities to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in calibration and test results, and inspection reports provided.

The International Laboratory Accreditation Cooperation is a network of laboratory and inspection accreditation bodies. Created in 1978, its purpose is to help remove technical barriers to trade caused by redundant testing requirements at the point of import.

Accreditation bodies, which have been evaluated and recognized by their peers as competent and reliable organizations, sign the ILAC Mutual Recognition Arrangement to facilitate the acceptance of products and services across national borders. The goal is to create a framework to support international trade through the removal of technical barriers. The ILAC MRA covers the fields of laboratory and inspection body accreditation.

As of Dec. 1, 2012, there were 78 MRA signatory accreditation bodies from 65 economies covering more than 90 percent of the world’s gross domestic product. Coverage remains to be achieved in much of Africa, Eurasia and the Middle East, but significant progress is being made in those areas with the recent establishment of the African Accreditation Cooperation and the Arab Accreditation Cooperation.

The TBT Agreement

Article 9 of the World Trade Organization’s Agreement on Technical Barriers to Trade — the TBT Agreement — requires that members, wherever practicable, formulate and adopt international systems of conformity assessment where a positive assurance of conformity with a technical regulation or standard is required. Article 6 of the agreement specifically recognizes accreditation as a means for realizing positive assurance:

6.1.1 adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence.1

The TBT Committee has recognized that the ILAC MRA is designed to facilitate acceptance of test results across economies and that acceptance of these results facilitates trade.

The experiences of six U.S. government agencies with the ILAC MRA described below have been presented to the WTO TBT Committee for the Sixth Triennial Review of the TBT Agreement.2 In addition, the United States has provided an example of recent guidance to U.S. agencies to promote the choice of trade facilitative conformity assessment procedures. The United States provides conclusions and recommendations for consideration under the Sixth Triennial Review.

Environmental Protection Agency

The ENERGY STAR and WaterSense programs include requirements that test data from third-party laboratories come from labs accredited by signatories to the ILAC MRA. Both programs are administered by the U.S. Environmental Protection Agency, but participation is voluntary rather than mandatory. EPA cites these international arrangements to provide greater assurance to consumers that products carrying the ENERGY STAR and WaterSense labels meet strict program requirements.

Participation in the ILAC MRA benefits the EPA in number of ways.

“We didn’t have to develop and implement our own set of rules,” says Eamon Monahan, program integrity lead, ENERGY STAR, Washington D.C. “Any kind of agency-specific rule creates costs or hassles for industry, and that was something we really wanted to avoid. We currently certify products in 65 categories, many of which are manufactured and tested overseas. Referencing the ILAC MRA took the EPA off the hook for developing a lot of criteria for labs or for conducting our own lab oversight. And, by working only with ILAC signatories, we have confidence that the labs have been appropriately assessed. We’ve now recognized 27 ILAC-signatory accreditation bodies from all over the world.”

Monahan believes that MRA participation provides a financial benefit to the EPA. “I can’t offer a dollar amount on how much money was saved due to the EPA’s reference of the ILAC MRA in our lab requirements,” he says. “I can say that the EPA being solely responsible for lab oversight or creating duplicative lab requirements would have cost the agency and industry very considerable resources.”

Consumer Product Safety Commission

The Consumer Product Safety Improvement Act, adopted into law in August 2008, requires certification, based on testing by a third-party conformity assessment body, of certain children’s products. The CPSIA required the U.S. Consumer Product Safety Commission to establish its own accreditation program or to designate an independent accreditation. After careful consideration of the considerable resources and time necessary to set up its own system, CPSC decided to rely on existing international arrangements.

In 2008, the CPSC issued regulations to recognize test data associated with children’s products coming from laboratories accredited by an ILAC MRA signatory accreditation body. CPSC registers laboratories that can perform compliance testing based on a simple application process identifying the relevant scope of accreditation from an ILAC MRA signatory accreditation body.

This move enabled CPSC to leverage its limited resources, yet provide for the acceptance of test data originating from the countries of export and reducing the need for redundant testing upon import.

“The MRA has had a tremendous impact on our group,” says Scott Heh, program manager in the CPSC Office of Hazard Identification and Reduction, Bethesda, Md. “With all of the products we see from manufacturers around the world — cribs and bunk beds from China and the United Kingdom, bike helmets and baby walkers from Taiwan and Italy — knowing that they have all been through an accepted standard of testing from an accredited lab gives us a greater level of confidence in those products. It provides a sense of consistency in quality.”

Federal Highway Administration

In September 2007, the Federal Highway Administration revised its regulation on the general requirements for quality assurance procedures for construction on all federal aid highway projects that are part of the National Highway System. After two years of implementation, FHWA requires the accreditation of laboratories that conduct crash tests on roadside hardware by an accrediting body that is a signatory to the ILAC MRA or the National Cooperation for Laboratory Accreditation. The FHWA determined that using accredited laboratories will improve the agency’s ability to trust that crash test laboratories are qualified to conduct and evaluate tests intended to determine the crashworthiness of roadside safety features. FHWA also determined that laboratory accreditation is widely recognized as a reliable indicator of technical competence.

Nicholas Artimovich, an FHWA highway engineer, Washington, D.C., agrees. “Even though being a part of the MRA has had no direct impact on the work of the agency,” he says, “the overall requirement for crash tests to be conducted by accredited laboratories has improved our confidence in the results received.”

Coast Guard

The U.S. Coast Guard accepts test results for lifesaving and fire safety equipment and materials from independent laboratories that are accredited via the International Organization for Standardization/International Electrotechnical Commission standard 17025, General Requirements for the Competence of Testing and Calibration Laboratories, and are signatories to the ILAC MRA. In October 2011, the USCG issued an interim rule to harmonize the USCG accepted independent laboratories program with the International Maritime Organization’s new guidelines on lifesaving equipment.

The new rule cited scheduling delays and increased expenses as a reason for using laboratories accredited through the ILAC process versus the use of Coast Guard-employed inspectors. Additionally, the USCG called out the modern trading system where many manufacturers produce lifesaving equipment for multiple-flag vessels, and must have their equipment approved by each nation. Using third-party accredited testing laboratories would allow manufacturers to satisfy requirements from multiple nations, which avoids the need for duplicative tests.

“Obviously, avoiding duplicative tests saves a lot of time,” says Kurt Heinz, chief, life saving and fire safety, U.S. Coast Guard, Washington, D.C. “A lot of the safety materials we use in ship construction, like the fire-resistant coatings on bulkheads and other areas, are manufactured in Europe and Asia, so being able to accept and depend on test results from labs in those countries makes sense,” he says. “And, less time spent doing routine approval work translates into more time spent on policy and standards development — which is a good thing.”

General Services Administration

The U.S. General Services Administration requires star of life ambulances procured by the U.S. government to be tested by an independent laboratory accredited in accordance with ISO/IEC 17025 by an accreditation body that is a signatory to the ILAC MRA.

All of the GSA’s ambulance standards are used to validate that their contractors are producing a quality product, and the MRA is one tool among many in their assessment of quality. They accept accreditation from MRA signatories but still perform source inspections on each ambulance ordered and procured for federal agencies under a GSA contract.

Food and Drug Administration

Over 10 years ago, the U.S. Food and Drug Administration pursued and obtained accreditation of its food testing laboratories. In January 2009, FDA issued a draft guidance document on data packages that addressed its preference to have food tested by laboratories accredited by an ILAC MRA signatory accreditation body to assure data credibility.

The Food Safety Modernization Act, enacted on Jan. 4, 2011, gives a statutory mandate to the FDA for recognition of laboratory accreditation associated with the testing of food. FDA is developing regulations to implement this provision. Information on implementation of FSMA is available on the FDA website, including information about the various FSMA regulations (when published).

Government Guidance on Federal Engagement in Standardization

On Jan. 17, 2012, three White House agencies — the Office of Management and Budget, the Office of Science and Technology Policy, and the Office of the U.S. Trade Representative — issued a memorandum for the heads of executive departments and agencies entitled “Principles for Federal Engagement in Standards Activities to Address National Priorities.” The goal of the memorandum was to clarify principles for engagement in those limited instances in which the federal government takes on a convening or active engagement role together with private sector standardization organizations to address a national priority. It is notable, however, that the memorandum also contains guidance aimed to strengthen implementation of Article 9 of the TBT Agreement. The federal memorandum notes:

Agencies should explicitly include consideration of conformity assessment approaches that take account of elements from international systems, to encourage private sector support and minimize duplicative testing. Agencies should evaluate whether their objectives necessitate creating government-unique conformity assessment schemes, which may be expensive to develop and maintain, may impose additional costs on the private sector and may not be recognized beyond national boundaries. In doing so, agencies should use existing best practices and leverage available resources in the private sector as well as within the Federal Government.3

Conclusion

These U.S. government agencies are benefiting from the use of internationally recognized accreditation under the ILAC MRA as it:

  • Eliminates the expense of government-administered programs;
  • Increases the confidence in results used to determine compliance with regulations;
  • Eliminates duplication in conformity assessment by reliance on recognized accreditation bodies;
  • Reduces costs of trade;
  • Encourages conformity assessment at the sources of supply; and
  • Upholds commitments of the WTO TBT treaty.

Even greater regulatory use of internationally recognized accreditation is likely once awareness of these benefits is more fully realized by the U.S. Congress and the executive branch of the U.S. government.

The United States has found that the ILAC MRA can help domestic regulators and other authorities in achieving their agency objectives and priorities. The ILAC MRA is cost effective and provides a robust way to ensure that products meet the requirements set out in technical regulations and standards. The United States has found, to date, that reliance on the ILAC MRA can help build a globally robust and trade-facilitative scheme that enables U.S. agencies to fulfill their mission. This, in turn, facilitates confidence that products comply.

References

1. World Trade Organization, Agreement on Technical Barriers to Trade, Article 6: Recognition of Conformity Assessment by Central Government Bodies.

2. Parts of this article are based on “The Use of the ILAC MRA and the IAF LA by Central Government Bodies: The Experience of the United States,” the U.S. Trade Representative submission to the WTO TBT Committee for the Sixth Triennial Review of the TBT Agreement, March 15, 2012.

3. Whie House Memorandum for the Heads of Executive Departments and Agencies, “Principles for Federal Engagement in Standards Activities to Address National Priorities,” Jan. 17, 2012.

Peter Unger is the president and CEO of the American Association for Laboratory Accreditation, Frederick, Md., a position he has held since 1996. He has been involved with national laboratory accreditation since 1978, and he currently serves as chairman of the International Laboratory Accreditation Cooperation.

Kessel Nelson is a freelance writer whose work has appeared in national and international publications, and he has covered diverse subjects, including art, energy, crime, science and health issues. He has a B.A. in history from the University of Pennsylvania and spends his time between Philadelphia and New York City.

This article appears in the issue of Standardization News.