U.S. Federal Agency Use of Accredited Laboratories
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.
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.
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."
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."
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."
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."
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.
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).
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
These U.S. government agencies are benefiting from the use of internationally recognized accreditation under the ILAC MRA as it:
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.
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.