A fundamental difficulty in discussing federal agencies’ certification requirements is that there is no official definition of the term in the federal government. In fact, a NIST official told us that there are almost as many definitions of a federal certification program as there are federal agencies. Different organizations may also use other terms to refer to the concept of certification, such as accreditation, registration, approval, or listing. These terms have specific and different meanings in some contexts but are used interchangeably in others. In any case, the nomenclature can be confusing. For example, in 1989 we reviewed laboratory accreditation requirements for 20 different programs and found that these programs used 10 different terms for accreditation, with at least 18 different meanings. Certification, accreditation, recognition, conformity assessment, and related terms all refer to types of standards-related activities, so a definition of “standards” can serve as a useful starting place. The International Organization for Standardization (ISO) defines standards as documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics to ensure that materials, products, processes, and services are fit for their purpose. ISO defines certification as the procedure by which a third party gives written assurance that a product, process, or service conforms to specified requirements or standards. Accreditation, according to ISO, refers to the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. In the context of certification, an accreditation body might accredit a certification body, such as a testing laboratory, as competent to carry out certification activities—in a sense, certifying the certifiers. Recognition is a term that is relatively new to conformity assessment activities in the United States, and it refers to designation by a government entity that an accreditation program is competent. Conformity assessment is the broadest term for these types of activities. According to the National Academy of Sciences, conformity assessment is the determination of whether a product or process conforms to particular standards or specifications. It may include such activities as sampling, testing, inspection, certification, registration, accreditation, and recognition. There are a great many standards or criteria for product quality, process reliability, or professional competence. NIST estimated that in the United States alone, approximately 49,000 voluntary standards have been developed by more than 620 organizations. The agency said this estimate does not include “a much greater number of procurement specifications. . . as well as mandatory codes, rules, and regulations containing standards developed and adopted at federal, state, and local levels.” NIST also pointed out that numerous foreign, regional, and international organizations produce standards of interest and importance to American businesses. For example, ISO has issued more than 10,000 international standards. Agency officials told us that use of these and other international standards has become increasingly common in the United States. The standards underlying certifications cover a wide range of products, processes, and professions. Some are product quality or safety standards, such as the American National Standards Institute (ANSI) standard for manually operated gas valves or the UL standard for communications cables. There are also standards for the performance and reliability of particular processes, as in ISO standards for quality management systems. Professional standards, such as the American Medical Association’s standards in medical practice, research, and education, are used to assure the qualifications and competence of individuals in specific disciplines or fields. The preceding examples also illustrate that standards can come from many sources. They can be established by industry or professional consensus standard-setting bodies, by governments through statutes or regulations, or by international standard-setting bodies. Certifications of products, processes, and services provide information on whether they can meet certain levels of quality, safety, or performance. However, certifications of people or organizations focus on an evaluation and designation of competence and qualifications. In professional and technical fields, certifications confirm the skills and knowledge of individuals who meet specific requirements (e.g., a certified public accountant). The professional certification process typically involves passing examinations and meeting other educational and/or experiential requirements. The choice of standards, the type of certification program, and the certification methodology used to assess conformity all have a significant impact on the validity and value of the information provided by a given certification. The total number of certification programs in the United States is unknown, but NIST has identified at least 178 private sector organizations that have product certification programs. In addition, the National Organization for Competency Assurance (NOCA) has identified at least 1,700 organizations based in the United States with programs for the certification or accreditation of individuals. The National Academy of Sciences and NIST have each noted that there is no central coordination of conformity assessment and related activities in the United States. Perhaps as a result, certification requirements can be duplicative and costly for those who must be certified or accredited. The fees for each certification exam can range from a few hundred dollars to over a thousand dollars, and the associated costs for annual fees and recertification in future years may be substantial. NIST officials told us that some laboratories must obtain multiple different accreditations—which often evaluate many of the same common elements in their evaluation processes—in order to provide testing services. NIST had found that laboratories desiring to be accredited or designated nationwide to conduct electrical safety-related testing of construction materials had to gain the acceptance of at least 43 states, over 100 local jurisdictions, the International Conference of Building Officials, the Building Officials and Code Administrators, the Southern Building Code Congress International, a number of federal agencies, and several large corporations. Congress has attempted to address some of the concerns about redundant certification requirements. For example, the Technology Transfer and Advancement Act of 1995 requires greater coordination of conformity assessment activities and attempts to facilitate mutual recognition among conformity assessment programs. Also, in June 1999 Congress amended the Fastener Quality Act in part to address concerns about potentially burdensome, costly, and duplicative testing and certification procedures that would have been imposed on industry. The amended law no longer requires NIST to approve organizations that accredit fastener testing laboratories. The amendments also exempt those fasteners already subject to the Federal Aviation Administration’s (FAA) regulation. However, despite such concerns, it also should be recognized that some certification programs and requirements foster opportunities for small businesses. For example, the Nationally Recognized Testing Laboratory (NRTL) Program implemented by the Occupational Safety and Health Administration (OSHA) recognizes private sector laboratories that meet the necessary qualifications specified in program regulations. OSHA officials pointed out that this program has given a number of small testing laboratories in the United States the opportunity to provide types of services that only a few organizations provided before the program went into effect. Our objectives in this review were to describe (1) the extent and variety of certification activities in the federal government; (2) the extent to which there are policies, procedures, or guidance governing those activities, either governmentwide or within selected agencies; and (3) an agency certification procedure that could serve as an example or “best practice” for other agencies. To address these objectives, we interviewed officials and obtained documentation from five federal agencies in which the Committee had expressed an interest: the Departments of Transportation (DOT) and Veterans Affairs (VA); and, within the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), FDA, and the National Institutes of Health (NIH). We also contacted officials in the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs, NIST, and the Office of Government Ethics (OGE) because of their responsibilities related to the issue of certification. We also interviewed and obtained documents from officials of NOCA and its related accreditation body, the National Commission for Certifying Agencies (NCCA). There are some important scope limitations to our review. Although we defined the term certification broadly to include such issues as accreditation, recognition, and conformity assessment, the report does not cover those Federal Acquisition Regulation certifications (e.g., the Certification of Final Indirect Costs and the Certification of Nonsegregated Facilities) that might be included as standard solicitation provisions and contract clauses but are not related to conformity with technical or professional standards. The scope of our first objective was governmentwide. However, as agreed with the Committee, it was not our intention to develop a comprehensive listing of every possible certification-related activity and requirement of federal agencies. Our intent was to illustrate the extent and variety of such activities in the federal government. As agreed with the Committee, our review of agency- specific policies, procedures, or guidance under the second objective was limited to selected agencies, including CDC, DOT, FDA, NIH, and VA. To address our third objective, we again focused primarily on specific certification examples from the five selected agencies. The examples cited in agencies other than the five selected for more in-depth review were limited to ones cited in published reports or suggested by persons we interviewed. We obtained only limited information on the certification requirements in agency procurement actions. Our choices of examples to highlight as best practices represent subjective decisions based on our observations and work in the regulatory arena. We conducted this review between November 1998 and August 1999 at the headquarters offices of the above-mentioned agencies in the Washington, D.C., area in accordance with generally accepted government auditing standards. We provided a draft of this report to the Secretaries of Commerce, Health and Human Services, Transportation, and Veterans Affairs and the Director of OMB for their review and comment. Their responses are presented at the end of this letter, along with our evaluation. Federal agencies engage in both a large number and a wide variety of certification-related activities. The certifications differ across several dimensions, including the origins of the requirements, their targets, which entity or entities do the certifying, whether the certifications are mandatory or voluntary, and the extent to which there is reciprocity with or recognition of other certifications or other organizations’ requirements.