oversight

Certification Requirements: New Guidance Should Encourage Transparency in Agency Decisionmaking

Published by the Government Accountability Office on 1999-09-24.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting Office

GAO              Report to the Chairman,
                 Committee on Small Business
                 House of Representatives


September 1999

                 CERTIFICATION
                 REQUIREMENTS
                 New Guidance Should
                 Encourage
                 Transparency in
                 Agency
                 Decisionmaking




GAO/GGD-99-170
United States General Accounting Office                                                           General Government Division
Washington, D.C. 20548




                                    B-281675
                                    September 24, 1999

                                    The Honorable James M. Talent
                                    Chairman, Committee on Small Business
                                    House of Representatives

                                    Dear Mr. Chairman:

                                    Federal agencies use many certification requirements to ensure quality in
                                    the goods and services they purchase. For example, before purchasing
                                    computer or electrical equipment, an agency may require that prospective
                                    sellers obtain a certification from Underwriters Laboratories or another
                                                                            1
                                    organization that the product is safe. An agency may also require that
                                    individuals in certain professions meet specific educational standards or
                                    be approved as competent by a particular organization before providing a
                                    service. There is no official definition of “certification” that is applicable to
                                    the activities of all federal agencies. However, the term generally refers to
                                    a process of providing written assurance that a product, process, service,
                                    organization, or individual conforms to specified requirements or
                                    standards for product quality, process reliability, or professional
                                    competence.

                                    Although certification requirements are intended to provide a measure of
                                    quality assurance, they can also engender concern on the part of affected
                                    parties. For example, businesses or individuals that wish to provide
                                    products or services to the government might need to obtain more than
                                    one certification to meet the requirements of different agencies. Also, an
                                    agency might select a particular certification organization while not
                                    accepting certifications in the same subject area from other organizations
                                    with similar qualifications.

                                    Because of these kinds of concerns regarding the potential effects of
                                    federal certification requirements on small businesses, you asked us 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

                                    1
                                     Underwriters Laboratories, Inc. (UL) is an independent, not-for-profit product safety testing and
                                    certification organization. A “UL” mark on a product indicates that UL found that samples of the
                                    product met UL’s safety requirements. The marks are commonly found on appliances, computer
                                    equipment, heaters, fuses, and other products.




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                   serve as an example or “best practice” for other agencies. We defined
                   certification broadly in this review to include those activities, methods,
                   and programs that agencies use to ensure conformance to standards, even
                   if the agencies did not use the term certification. Therefore, this report
                   also includes certification-related activities, such as accreditation,
                   recognition, and conformity assessment.

                   Federal agencies engage in a large number and wide variety of
Results in Brief   certification-related activities, which is at least partially because of the
                   number and diversity of the standards upon which they are based. The
                   National Institute of Standards and Technology (NIST) publishes
                   directories listing more than 200 federal government procurement and
                   regulatory programs in which agencies provide or require certification,
                                                           2
                   accreditation, listing, or registration. However, these directories provide
                   only a partial inventory of agencies’ activities because they focus primarily
                   on certifications of products and services; they do not cover individual
                   procurement actions in which agencies require vendors or contractors to
                   have particular certifications. Certification activities also vary across
                   multiple dimensions, including the origin 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.

                   Specific guidance regarding the selection of specific requirements or
                   certifying organizations is limited. Federal procurement law imposes some
                   limits on agencies’ use of certification requirements, restricting the use of
                   certification requirements in solicitations for government contracts to
                   instances in which the requirements are specifically imposed by law or the
                   agencies show a particular need and, if possible, allow for alternatives.
                   Some agencies have established certification procedures and criteria for
                   individual programs, and agency officials identified some related policies,
                   procedures, and guidance that can affect their certification activities.
                   However, there is currently no governmentwide guidance—or agencywide
                   guidance in the five agencies we reviewed—regarding all types of
                   certification requirements. NIST has prepared draft guidance for executive
                   branch agencies on conformity assessment activities, including
                   certification, which it plans to issue for public comment later this year.



                   2
                    Congress established NIST (formerly the National Bureau of Standards) in 1901 to support industry,
                   commerce, scientific institutions, and all branches of the government. It is an agency of the
                   Department of Commerce, and its primary mission is to promote economic growth in the United States
                   by working with industry to develop and apply technology, measurements, and standards.




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             One “best practice” that we have supported in the regulatory arena—
             transparency of agency decisionmaking—also appears applicable to
             certification requirements, particularly given the complexity and diversity
                                                                                3
             of certification activities and organizations in the United States. In the
             certification actions that we examined, the criteria that the agencies used
             to establish a particular requirement or select a particular certifying
             organization were very clear in some instances but not clear in others. For
             example, in implementing its mammography program, the Food and Drug
             Administration (FDA) published detailed procedures and criteria for
             certification of personnel and facilities providing mammography services,
             as well as the approval of accreditation bodies. Other agencies’
             certification actions were not as transparent, and certification bodies that
             were not selected raised questions about the criteria that the agencies
             used. However, in each of those cases, agency officials were able to
             provide us with the rationale for their actions.

             A fundamental difficulty in discussing federal agencies’ certification
Background   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
                                                                            4
             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



             3
             See, for example, Regulatory Reform: Changes Made to Agencies’ Rules Are Not Always Clearly
             Documented (GAO/GGD-98-31, Jan. 8, 1998); and Dietary Supplements: Uncertainties in Analyses
             Underlying FDA’s Proposed Rule on Ephedrine Alkaloids (GAO/HEHS/GGD-99-90, July 2, 1999).
             4
              Laboratory Accreditation: Requirements Vary Throughout the Federal Government (GAO/RCED-89-
             102, Mar. 28, 1989).




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                                                                      5
                          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.

Numerous Standards        There are a great many standards or criteria for product quality, process
                          reliability, or professional competence. NIST estimated that in the United
Underlie Certifications   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

                          5
                           ISO is an international organization that writes standards. Established in 1947, ISO is a
                          nongovernmental federation of national standards bodies from about 130 countries. Its work results in
                          international agreements that are published as International Standards.




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                         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 Reflect   Certifications of products, processes, and services provide information on
                         whether they can meet certain levels of quality, safety, or performance.
Diversity of Standards   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
                                                                       6
                         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.
                         6
                             NOCA is a private sector national umbrella organization in the area of certification.




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                         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
Objectives, Scope, and   certification activities in the federal government; (2) the extent to which
Methodology              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



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                        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
                                                 7
                        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
Agencies Engage in a    certification-related activities. The certifications differ across several
Wide Variety of         dimensions, including the origins of the requirements, their targets, which
Certification-Related   entity or entities do the certifying, whether the certifications are
                        mandatory or voluntary, and the extent to which there is reciprocity with
Activities              or recognition of other certifications or other organizations’ requirements.
                        The extent of agency involvement in the process can also vary, ranging
                        from instances in which an agency might simply apply a certification
                        requirement established by other entities to cases in which the agency is
                        actively involved in developing and enforcing a specific requirement.

                        7
                         See 41 U.S.C. 425(c) for limitations on the use of requirements for certification by offerors or
                        contractors in the Federal Acquisition Regulation.




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Federal Certification       We did not attempt to develop a compendium of every federal agency
                            certification or certification-related activity and requirement, and it would
Activities Are Numerous     be difficult to do so given the absence of a common understanding and
and Diverse                 definition of the term “certification requirement” in the federal
                            government. However, it is clear that federal agencies engage in a large
                            number of certification-related activities. For example, NIST publishes
                            directories that list more than 200 federal procurement and regulatory
                            programs in which agencies provide or require some form of certification.
                            The NIST directories provide only a partial inventory of agencies’
                            activities, though, because they primarily focus on certification of products
                            and services. Also, the directories do not cover individual procurement
                            opportunities in which agencies require a vendor or contractor to have a
                            particular certification, accreditation, or registration in order to
                            participate.

                            Agencies’ certification requirements also vary in a number of ways,
                            reflecting the variety of the underlying standards. One such dimension is
                            the scope of the certification programs and requirements. For example,
                            FAA’s comprehensive system of certifications for the civil aviation system
                            is quite broad, covering numerous categories of equipment, personnel, and
                            facilities. On the other hand, one of the Environmental Protection Agency’s
                            (EPA) requirements (pursuant to section 609 of the Clean Air Act) is very
                            specific, focused solely on operators who service motor vehicle air
                            conditioners and requiring them to be certified under an EPA-approved
                            program before offering their services. Another narrowly focused
                            certification requirement is in FDA regulations that are designed to
                            prevent botulism. The regulations require that a “processing authority”
                            must certify the competency of “low-acid canned food retort operators”
                            (i.e., the operators of heating and pressure cookers).

                            Federal agencies’ certification-related activities also vary with regard to
                            the extent of agency involvement in the certification process. For example,
                            an agency might be deeply involved in developing and/or enforcing a
                            specific certification requirement. On the other hand, the agency might
                            simply apply a requirement established by other entities, such as when an
                            agency incorporates technical or professional certification requirements
                            by reference in solicitations for specific products or services.

                            Other ways that certification requirements vary include the following.

                          • The target of certification.
                            • Product
                            • Profession



                            Page 8                                 GAO/GGD-99-170 Certification Requirements
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  • Process
  • Facility or organization

• Who does the certification.
  • Federal government
  • State or local governments
  • Joint commissions
  • Private sector, professional, or trade organizations
  • Self-certification

• The origin or basis of the certification requirement.
  • Statutory requirements
  • Agency regulatory actions
  • International agreements
  • Industry consensus or nonconsensus requirements
  • Procurement actions

• The degree of compulsion on those being certified.
  • Voluntary
  • Mandatory
  • Required for program participation

• Whether other certifications are accepted or recognized.
  • Only the specified certification is accepted
  • Other certifications accepted or recognized

  According to NIST officials, the risk associated with a particular regulatory
  action or procurement can be an important factor influencing choices
  within these various dimensions. If the perceived risk is low, for instance,
  an agency might determine that certification is voluntary and accept a
  manufacturer’s self-certification. However, if the risk associated with
  failure to meet standards is serious, the agency might choose to make
  certification mandatory and accept certification from only a federally
  recognized laboratory.

  Appendix I describes a number of specific agency certification programs
  and requirements that illustrate these kinds of differences. Some of the
  requirements differ on multiple dimensions. For example, the National
  Marine Fisheries Service within the Department of Commerce has a
  program for the inspection and certification of seafood products and
  processing operations. The Seafood Inspection Program is a voluntary
  program carried out pursuant to the Agricultural Marketing Act of 1946, as



  Page 9                                 GAO/GGD-99-170 Certification Requirements
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                             amended; involves inspection by licensed federal and state agents; and
                             provides certification recognized by other federal, state, and foreign
                             government agencies as well as some private and international
                             organizations. In contrast, a provision in an NIH procurement solicitation
                             stated that a prospective contractor’s supervisors responsible for
                             inspection of the agency’s biohazard cabinets “must be NSF accredited
                                                                 8
                             biohazard cabinet field certifiers.” This provision is based on an industry
                             consensus standard, targets professional competence, involves
                             accreditation by a private sector third party, represents a mandatory
                             requirement for prospective contractors, and recognizes only one source
                             for the certification.

                             Federal procurement law establishes some legal boundaries on the
Little Guidance Exists       certification requirements used in federal procurement. In addition, agency
on Agency                    officials pointed out that their general procedures and practices for
Certification                rulemaking and procurement can serve a useful role in notifying the public
                             and soliciting feedback on proposed certification requirements. However,
Requirements                 there is little in the way of general policies, procedures, or guidance
                             governing how agencies should establish certification requirements or
                             select certification bodies, except at the level of some individual agency
                             programs. Agency officials told us that they primarily viewed certification
                             as an industry or professional concern rather than as a federal issue, and
                             therefore they tended to rely on the “industry standard” or “nationally
                             recognized” requirements. NIST has prepared draft guidance for federal
                             agencies on conformity assessment activities, including certification. This
                             guidance is currently under review at OMB, and NIST expects to publish it
                             for public comment later this year.

Procurement Law Sets         The Competition in Contracting Act of 1984 provides that a solicitation for
                             a government contract may include a restrictive provision only to the
Some Boundaries on           extent that the provision is authorized by law or is necessary to satisfy the
Certification Requirements   agency’s needs. Some agency-specific acquisition regulations mirror the
                             Competition in Contracting Act’s limitations on the use of unnecessarily
                             restrictive certification requirements. For example, VA’s regulations allow
                             requirements that offerors conform to technical standards that are
                             generally recognized and accepted in the industry involved. However, if
                             there is a choice of laboratories available to certify the quality of the




                             8
                              NSF refers to NSF International, founded in 1944 as the National Sanitation Foundation. NSF is an
                             independent, not-for-profit organization active in standards development and certification programs
                             related to public health safety and protection of the environment.




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                            product involved, the regulations also say that the requirements must not
                                                                                               9
                            indicate that only one laboratory’s certificate will be acceptable.

                            In our bid protest decisions, we have generally not objected to a
                            requirement that an item conform to a set of standards adopted by a
                            nationally recognized organization in the field or a requirement for
                            independent laboratory certification that such standards are met.
                            However, we have found requirements unduly restrictive if they require
                            approval by specific organizations without recognition of equivalent
                                       10
                            approvals. The absence of an endorsement by a particular private
                            organization should not automatically exclude offers that would otherwise
                            meet a procuring agency’s needs.

Certification Guidance Is   These procurement provisions notwithstanding, there is little in the way of
                            general policies, procedures, or criteria governing how agencies should
Currently Limited to        proceed in establishing certification requirements or selecting certifying
Specific Programs           bodies. Neither the agency officials we interviewed nor agency documents
                            we reviewed identified any governmentwide guidance or, for the selected
                            agencies we reviewed, agencywide guidance focused specifically on
                            certification activities. The only specific certification guidance that we
                            could identify was limited to particular programs. In some of these
                            programs—such as FDA’s Mammography Program; the Coast Guard’s
                            requirements for vessel design, inspection, and certification; and OSHA’s
                            NRTL Program—the agencies have established detailed procedures and
                            criteria governing their certification requirements and/or the selection of
                            certifying bodies.

                            In general, however, officials in the five agencies that we contacted tended
                            to view certification as an industry or professional issue rather than a
                            federal one. Consequently, the agencies’ selection of specific certification
                            requirements or certifying organizations were driven more by the
                            particular profession, industry, or market sector involved than by federal
                            considerations. For example, officials from VA and NIH said that their
                            agencies commonly rely on national consensus bodies and their “nationally
                            recognized” or “industry standard” certifications for a given sector. NIST
                            officials said that a common finding from their meetings and workshops is
                            that people tend to use the certification or accreditation program with
                            which they are most familiar.


                            9
                                 48 C.F.R. 852.211-75.
                            10
                                 See, for example, Aegis Analytical Laboratories, Inc., B-252511, July 2, 1993.




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NIST Has Developed Draft       NIST has taken a first step toward developing governmentwide
Certification Guidance         certification guidance. In response to requirements in the National
                               Technology Transfer and Advancement Act of 1995 and OMB Circular A-
                               119, and with input from the Interagency Committee on Standards Policy
                               (ICSP), NIST has prepared draft guidance for issuance by the Secretary of
                                                                                                      11
                               Commerce on conformity assessment activities, including certification.
                               This draft guidance is currently under review at OMB, and NIST expects to
                               publish it in the Federal Register for public comment later this year.

                               NIST officials explained that the guidance would apply to all agencies that
                               set policy for, manage, operate, or use conformity assessment activities
                               and results, both domestic and international, except for activities carried
                               out pursuant to international treaties. In addition to suggesting common
                               terminology and definitions for agencies to use, NIST expects the guidance
                               to define agency responsibilities in a number of areas, including the
                               following:

                             • identifying private sector conformity assessment practices and programs
                               and considering use of the results of such practices or programs in new or
                               existing regulatory and procurement actions,
                             • using relevant guides or recommendations for conformity assessment
                               practices published by domestic and international standardizing bodies,
                               and
                             • working with other agencies to avoid unnecessary duplication and
                               complexity in federal conformity assessment activities.

                               However, NIST officials also pointed out that the guidance would not
                               preempt the agencies’ authority and responsibility to make regulatory or
                               procurement decisions authorized by statute or required to meet
                               programmatic objectives and requirements. They also said the guidance
                               would not suggest that agencies explain why they selected one
                               certification requirement or organization over other possible candidates.

Related Policies and           Although there is currently no governmentwide guidance specifically on
                               certification requirements, agency officials noted several related policies
Procedures Also Affect         and procedures that can affect those requirements. Those policies and
Certification Requirements     procedures include OMB Circular A-119, federal ethics and conflict-of-


                               11
                                ICSP consists of representatives from each federal executive agency and advises the Secretary of
                               Commerce and other executive branch agencies on standards policy matters. The committee reports to
                               the Secretary through the Director of NIST. The publication of the guidance is in response to
                               requirements in the National Technology Transfer and Advancement Act of 1995 as well as OMB
                               Circular A-119.




                               Page 12                                          GAO/GGD-99-170 Certification Requirements
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interest laws, and agencies’ rulemaking and procurement procedures and
regulations.

OMB Circular A-119 says that all federal agencies must use voluntary
consensus standards in lieu of government-unique standards in their
procurement and regulatory activities, except where inconsistent with law
                          12
or otherwise impractical. If an agency uses government-unique standards,
it must explain why it did so in a report to OMB through NIST. The circular
also says that agencies must consult with voluntary consensus standards
bodies, both domestic and international, and must participate with such
bodies in the development of voluntary consensus standards “when
consultation and participation is in the public interest and is compatible
with their missions, authorities, priorities, and budget resources.”

Agency officials from each of the selected agencies we reviewed noted that
employees of their agencies commonly participate in such consensus
bodies, including ones that help to establish certification requirements.
Agency employees who, at government expense, participate in such
activities on behalf of the agency must do so as specifically authorized
agency representatives and are subject to ethics laws regarding
participation by federal employees in activities of outside organizations.
However, according to the Office of Government Ethics, there is no
conflict of interest if an authorized agency representative participated in
developing a voluntary consensus standard and the agency subsequently
                                          13
selected that standard as a requirement. Circular A-119 does caution,
however, that agency participation in voluntary consensus bodies does not
necessarily connote agency agreement with, or endorsement of, decisions
reached by such organizations.

The circular does not apply to conformity assessment activities carried out
pursuant to treaties, which may impose their own obligations on federal
agencies. NIST officials pointed out that the World Trade Organization
(WTO) Agreement on Technical Barriers to Trade, in particular, includes
conformity assessment obligations that apply to federal agencies.
According to WTO, the intent of this agreement is to ensure that
regulations, standards, testing, and certification procedures do not create

12
   OMB revised the circular on February 10, 1998, in part to make the terminology consistent with the
National Technology Transfer and Advancement Act of 1995. That act codified existing policies in A-
119, established reporting requirements, and authorized NIST to coordinate conformity assessment
activities of agencies.
13
   The Office of Government Ethics is a small independent agency that has as its mission exercising
leadership in the executive branch to prevent conflicts of interest on the part of government employees
and to resolve those conflicts of interest that do occur.




Page 13                                             GAO/GGD-99-170 Certification Requirements
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unnecessary obstacles to trade. The agreement includes articles regarding
procedures for assessment of conformity and recognition of conformity
assessment by central government bodies. For example, the agreement
encourages countries to recognize each other’s testing procedures.
Members of WTO are also encouraged to permit conformity assessment
bodies located in the territories of other members to participate in their
conformity assessment procedures under conditions no less favorable than
those accorded to bodies within their own territories or the territories of
any other countries.

Agency officials also said that their general procedures and regulations
governing rulemaking and procurement play an important role in
certification activities. In particular, they noted that such procedures and
regulations provide valuable opportunities for an agency to inform the
public and solicit feedback on proposed certification requirements. FDA
officials said their agency’s procedural rules and regulations require them
to use rulemaking in order to establish an enforceable certification
requirement.

DOT and FDA used the rulemaking process in developing or implementing
several of the agencies’ certification requirements. Although DOT and FDA
officials acknowledged that rulemaking procedures take considerable time
and effort, they noted that those procedures could also help the agencies
obtain informed comments and document certification decisions. DOT
officials said the use of the rulemaking process was particularly valuable in
the establishment of certification requirements for subjects that are new to
the department or in which DOT has little expertise. For example,
proposed departmental regulations intended to reduce alcohol misuse by
employees in DOT-regulated transportation industries included important
roles for substance abuse professionals (SAPs). In response to public
comments on the proposed rule, DOT refined and expanded its definition
of SAPs in the final regulations and said alcohol and drug abuse counselors
certified by the National Association of Alcoholism and Drug Abuse
                                                                        14
Counselors (NAADAC) Certification Commission could serve as SAPs.

However, agency officials also emphasized that rulemaking may not
always be a necessary or appropriate procedure for making certification
decisions. In particular, NIH and CDC officials distinguished their
research-oriented agencies from regulatory agencies, noting that they tend

14
   Subsequently, DOT recognized another certifying organization that petitioned to be recognized and
asked for comment on a proposed requirement that certification organizations obtain NCCA
accreditation for inclusion in the SAP definition. See 64 FR 29831.




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                      to act through nonmandatory guidance or recommendations, not through
                      rulemaking. DOT officials said that they generally do not use rulemaking
                      procedures if certification requirements are part of a one-time
                      procurement or contract. However, they said rulemaking might be the
                      appropriate approach if the requirements are part of a recurring
                      procurement.

                      Agency officials also noted that procurement procedures can play a role in
                      their agencies’ choice of certification requirements and certifying
                      organizations. Contracting officials emphasized the opportunities provided
                      throughout the procurement process for prospective bidders to question
                      proposed certification requirements and to suggest changes or other
                      equivalent certifications that might meet the agency’s needs. NIH officials
                      noted that in addition to responding to the solicitation itself, bidders can
                      comment on the draft request for proposal (published to see if there are
                      enough sources) and the announcement of forthcoming solicitations to the
                      market that appears in the Commerce Business Daily. Officials from CDC,
                      FDA, and NIH pointed out that any solicitation could be the subject of bid
                      protests if their agencies used procurement provisions that some entities
                      believed were too restrictive.

                      As noted previously, agency certification actions are numerous and vary
Transparency of       substantially. Therefore, specification of a particular certification “best
Certification         practice” would likely depend on the context of the certifications. Rather
Decisionmaking Is a   than attempting to develop criteria for selecting among these procedures,
                      we focused on one practice that we have supported in the regulatory
“Best Practice”       arena—transparency, or clearly describing the basis for agency
                      decisionmaking. Transparency in certification decisionmaking is important
                      because those decisions can have significant implications for affected
                      parties, but they are sometimes made with little public explanation.

                      An agency’s certification decisions can be transparent either
                      retrospectively (explaining why a decision has been made) or
                      prospectively (explaining the criteria it will use in making future
                      decisions). As noted previously, OMB Circular A-119 requires agencies that
                      develop government-unique standards to explain why they did not use
                      voluntary consensus standards. However, we are not aware of any
                      statutory or regulatory provisions requiring agencies to disclose why they
                      selected one voluntary standard, certification, or certifying organization
                      over another, or to describe the criteria they will to use to make those
                      decisions in the future.




                      Page 15                               GAO/GGD-99-170 Certification Requirements
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Transparency of Agency       The transparency of the agency certification actions that we reviewed
                             varied dramatically. In some instances, the agencies clearly documented
Certification Requirements   the criteria that they used or planned to use to select particular
Varies                       requirements or certifying organizations. Other certification decisions
                             were not as transparent, with the criteria less clear or well documented.
                             However, agency officials were able to provide us with justifications for
                             their actions in these instances during our review.

                             FDA’s certification requirements in its previously mentioned
                             Mammography Program are very transparent. The program’s regulations
                             published in the Federal Register provide detailed procedures and criteria
                             for certification of personnel and facilities providing mammography
                             services, as well as the procedures and criteria that FDA uses to approve
                             accreditation bodies. FDA has developed and publicized the regulations
                             through a series of public rulemaking notices, building on procedures and
                             criteria promulgated in earlier regulations issued by the Department of
                             Education and the Health Care Financing Administration within the
                             Department of Health and Human Services. The agency also provides
                             ongoing guidance on the implementation of this program and its
                             requirements, notifying the public of any updates in the guidance through
                             quarterly Federal Register notices that announce the availability of and
                             changes in FDA guidance documents.

                             DOT has also clearly explained in several of its rulemaking documents
                             how it made or planned to make decisions on the selection of particular
                             certifying organizations. For example, in a 1997 final rule, the Coast Guard
                             allowed an alternative inspection compliance method to fulfill
                                                                                  15
                             requirements for vessel inspection and certification. Previously, these
                             inspections and certifications had to be performed by the Coast Guard.
                             Under the alternative, the Coast Guard can issue a certificate of inspection
                             based upon reports by a “recognized, authorized classification society”
                             that a vessel complies with United States and international safety rules,
                             conventions, or other specified requirements. In order to receive
                             recognition from the Coast Guard, the regulation requires a classification
                                                                  16
                             society to meet 23 specific criteria.



                             15
                                See 62 FR 67525 (Dec. 24, 1997). This change was made in response to concerns raised by the U.S.
                             maritime industry in comments on an earlier notice of proposed rulemaking regarding the cost
                             burden—and perceived competitive disadvantage to U.S. merchant vessels—of redundant inspection
                             requirements.
                             16
                              For example, one of the standards was that the classification society must maintain an internal quality
                             system based on ANSI standard ANSI/ASQC Q9001 or an equivalent quality standard.




                             Page 16                                             GAO/GGD-99-170 Certification Requirements
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In DOT’s previously mentioned substance abuse-prevention program, the
department’s rulemaking notices clearly documented the department’s
reasons for selecting or rejecting particular certifying bodies. Although
DOT did not describe the specific criteria it would use to accept or reject
professional certifications at the time it issued the proposed rule, the
department’s response to public comments in the final rule clearly
described why it accepted certification by NAADAC and rejected state
certifications. DOT noted that NAADAC was a national organization and
that commenters provided information showing that the training and
experience needed to meet NAADAC standards and certification
requirements were sufficient for participation as a SAP in DOT’s alcohol
misuse prevention programs. DOT said it rejected suggestions that the SAP
definition include state-certified counselors because qualification
standards varied dramatically by state and did not always result in state-
certified counselors having the experience or training DOT deemed
necessary to implement the objectives of its rules.

However, the reasoning behind some other agency certification
requirements that we examined was not as clearly documented or
otherwise explained. These specific cases involved the selection of
particular certification bodies, and organizations that were not selected
raised questions about the criteria that the agencies used. One such
example was VA’s implementation of new procedures, effective July 1,
1997, generally requiring that newly hired physicians be board-certified in
the clinical specialty in which they will practice. The VA Undersecretary
for Health later specified that the only certifying bodies recognized by VA
for this purpose would be the American Board of Medical Specialties
(ABMS) for allopathic physicians and the Bureau of Osteopathic
Specialists (BOS) for osteopathic specialists. Although the subsequent
announcement indicated that the two organizations were “umbrella
organizations for approving medical specialty boards in the United States”
and described the importance of board certification, the announcement
                                                          17
did not indicate why these organizations were selected. Another
certifying organization (the American Association of Physician Specialists,
Incorporated) and the House Committee on Veterans’ Affairs then
questioned why VA recognized only ABMS and BOS certifications. The
Committee requested that VA provide the criteria used to evaluate and
select those two organizations. In its response to the Committee, VA stated
that certifying groups vary widely in their requirements and that ABMS and
17
   VA noted that certification of physicians ensures that medical specialists have successfully completed
an approved educational program and an evaluation designed to assess their possession of knowledge,
experience, and skills needed to provide high quality patient care within the specialty. VA also said that
board certification is a widely accepted measure of physician qualifications.




Page 17                                               GAO/GGD-99-170 Certification Requirements
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BOS are “the standard certifying organizations recognized throughout
American medicine.” However, VA did not further describe why it selected
these two certifying organizations.

VA officials told us during this review that they rely on consensus
practices and standards of the health care profession in establishing
certification requirements. They said VA’s use of ABMS and BOS
certifications can be traced back to a 1980 decision by the Chief Medical
Director to accept ABMS and BOS physician board certifications for
Incentive Special Pay purposes. In 1997, VA extended those same
certifications that were required for special pay purposes to employment,
“grandfathering” currently employed physicians. VA officials also noted
that they had canvassed other federal agencies involved in health care
issues—including the Department of Defense, the Public Health Service,
NIH, CDC, and the Bureau of Prisons—and found that essentially all
recognized ABMS and BOS as the two accepted organizations for board
certification purposes. The officials also described to us some of their
expectations of a health professional certification program—in essence,
informal selection criteria. These included (1) accreditation for
educational requirements (undergraduate, medical school, and residency
program); (2) accreditation for post-residency experience; and (3)
certifying exams in the area of specialty. Finally, they pointed out that by
law, the Secretary for Veterans Affairs has special authority to make
personnel decisions. Although the description that VA officials provided
explains how ABMS and BOS were selected, it was not contained in any
published document and did not explain what criteria other organizations
would need to meet to be accepted by VA.

Another agency certification decision that was not transparent to affected
entities involved a 1996 NIH solicitation for the maintenance, certification,
and decontamination of certain types of facilities and equipment, including
biological safety cabinets. NIH implicitly designated NSF International as
the sole certifying organization by including a requirement in the
solicitation that the full-time on-site supervisor for specific locations be an
NSF-accredited biohazard cabinet field certifier. NIH did not explain why
only NSF accreditation was acceptable. As in the VA example, other
certifying organizations that were not designated raised questions about
the restriction to NSF’s program. NIH officials told us during our review
that NSF had the only accreditation program that was nationally
recognized. The officials also pointed out that they applied the restrictive
provision as narrowly as possible—requiring accreditation only for
supervisors—while still addressing the agency’s primary need to protect
the safety of NIH personnel.



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Common Criteria Used to         Agencies can make clear the criteria they used or plan to use to select a
                                particular certification requirement or certifying organization in any
Select Certifying               number of ways. However, those cases that we reviewed in which agencies
Organizations                   clearly documented the criteria they used to select certifying organizations
                                appeared to have certain common elements. For example, in most of these
                                cases the agencies included discussions of elements such as the following:

                              • the structure, purpose, and other characteristics of the organization (e.g.,
                                its legal status and composition of the governing board);
                              • the resources and qualifications of the organization (e.g., technical
                                competence of the staff, adequacy of management and quality control
                                systems, and appropriate experience);
                              • the certification procedures or mechanisms used by the organization (e.g.,
                                public documentation, use of valid test or evaluation methods,
                                enforcement of certification requirements, and appeals or due process
                                procedures regarding certification decisions); and
                              • other factors (e.g., compatibility with or recognition of related
                                certifications and the costs and fees associated with certification).

Transparency Is Not Free or     However, transparency is not free. The Director of CDC’s Procurement
                                and Grants Office told us that a governmentwide requirement for complete
a Panacea                       documentation of each agency certification action would carry with it
                                certain costs, including possible delays in procurement and the issuance of
                                agency rules. The Director pointed out that the relative infrequency of
                                concerns expressed about agency certification requirements could mean
                                that those costs could exceed the benefits derived from documentation
                                requirements. He also noted that mechanisms are already in place to
                                address concerns about restrictive solicitation provisions and said that
                                agencies will probably hear from affected entities if the requirements are
                                considered unreasonable and/or restrictive of competition. Finally, both he
                                and DOT officials emphasized that no one uniform approach is appropriate
                                in the varied conditions in which certifications are used.

                                Also, transparency in an agency’s certification requirements does not
                                guarantee that the process will result in the best (or even a good) decision.
                                Conversely, lack of transparency does not necessarily mean that an
                                agency’s certification decision will not be good or appropriate. At a
                                minimum, however, the opportunities for alternative certification
                                organizations or requirements to be put forward are improved if agencies
                                are transparent in establishing their requirements and vetting their
                                decisions with the public.




                                Page 19                                GAO/GGD-99-170 Certification Requirements
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              Federal agencies’ certification requirements are an invaluable tool in
Conclusions   helping to ensure product quality, process reliability, and professional
              competence in a variety of venues. Without those requirements, federal
              agencies would have to independently evaluate the safety of products,
              whether certain procedures will yield the desired results, and whether
              individual workers possess the skills required to perform a given task.

              Federal agencies have broad latitude in the selection of certification
              requirements and certifying organizations, which can result in what appear
              to be inconsistencies of application. For example, five agencies might each
              require a different certification for the same type of product or service.
              Businesses that want to provide that product or service to each of the
              agencies would therefore have to incur the expense associated with
              obtaining five certifications. Also, an agency can accept certifications from
              one certifying organization while not accepting certifications in the same
              subject area from other organizations with what appear to be similar
              qualifications. Organizations that are not selected would then have to forgo
              any income associated with providing certifications for that agency.

              These apparent inconsistencies are exacerbated when the reasons behind
              the agencies’ certification decisions are unclear. Transparency of these
              decisions could improve their perceived legitimacy, particularly when
              more than one certification option is available to an agency. The means by
              which agencies’ certification decisions can be made transparent will
              depend on the context in which the requirements are imposed. For
              example, if an agency’s certification requirement is part of a procurement
              action, the agency can make clear the basis of that requirement in the
              request for proposals. Some agencies have also used the rulemaking
              process to delineate the rationale behind their certification requirement
              decisions. However, although contracting and rulemaking processes are
              convenient mechanisms for certification transparency, they are not always
              available because some certification requirements do not arise in either
              environment.

              The extent to which agencies’ certification requirements need to be
              explained will also depend on the circumstances surrounding the
              certification requirement. For example, only a brief explanation should be
              necessary when an agency picks a certifying organization that is generally
              acknowledged to be the only such organization available. On the other
              hand, a more elaborate explanation may be necessary when an agency
              selects one organization over others with what appear to be similar
              qualifications. In that case, transparency can also help organizations not




              Page 20                                GAO/GGD-99-170 Certification Requirements
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                      selected to understand what they must do to meet the agency’s
                      requirements.

                      The forthcoming guidance being developed by NIST for the Secretary of
                      Commerce may help bring more uniformity to the certification process,
                      thereby making that process more intelligible to contractors, regulated
                      parties, and other entities affected by the requirements. However, NIST
                      officials said that the draft guidance does not directly address the issue of
                      certification transparency. Although it would probably be unwise to
                      recommend a single transparency approach, the guidance could generally
                      advocate the concept of transparency in agencies’ certification decisions
                      and suggest alternative mechanisms by which those decisions could be
                      explained to the public.

                      We recommend that the Secretary of Commerce include a section in the
Recommendation        conformity assessment guidance being developed that specifically
                      addresses the transparency of agencies’ certification decisionmaking.
                      Specifically, we believe that the guidance should encourage agencies to
                      publicly explain why particular certification decisions were made or how
                      certification decisions in the future will be made. The guidance should
                      present alternative approaches for the agencies to consider in making their
                      certification decisions more transparent, but it should not advocate that a
                      single approach be used in all circumstances.

                      We provided a draft of this report to the Secretaries of Commerce, Health
Agency Comments and   and Human Services, Transportation, and Veterans Affairs and the Director
Our Evaluation        of OMB for their review and comment. Officials from HHS, DOT, and OMB
                      informed us that their agencies did not have comments on our draft report.
                      VA did not provide comments. On September 13, 1999, the Secretary of
                      Commerce provided written comments on the draft report. The Secretary
                      said that the Department would address our recommendation on the issue
                      of transparency in agencies’ certification decisionmaking during the public
                      comment period for the conformity assessment guidance being prepared
                      by NIST. The Secretary noted that NIST would work with ICSP on the
                      most effective way to address the issues of transparency for both
                      regulatory and procurement agencies. The Department of Commerce also
                      provided some technical comments and suggestions, which we
                      incorporated as appropriate.

                      To ensure that we had accurately characterized the examples of agency
                      certification programs and requirements presented in an appendix to this
                      report, we also provided the relevant portions of our draft report to
                      officials in the Departments of Agriculture, Housing and Urban



                      Page 21                                GAO/GGD-99-170 Certification Requirements
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Development, and Labor and the Environmental Protection Agency. They
provided technical comments and suggestions, which we included in this
report as appropriate.

We are sending copies of this report to Representative Nydia M. Velazquez,
Ranking Minority Member of the House Committee on Small Business. We
are also sending copies to the Honorable William M. Daley, Secretary of
Commerce; the Honorable Donna E. Shalala, Secretary of Health and
Human Services; the Honorable Rodney E. Slater, Secretary of
Transportation; the Honorable Togo D. West, Jr., Secretary of Veterans
Affairs; and the Honorable Jacob Lew, Director of OMB. Copies will also
be made available to others on request. Major contributors to this report
are acknowledged in appendix II. If you have any questions about this
report or would like to discuss it further, please contact me on (202) 512-
8676.

Sincerely yours,




L. Nye Stevens
Director, Federal Management
   and Workforce Issues




Page 22                               GAO/GGD-99-170 Certification Requirements
Page 23   GAO/GGD-99-170 Certification Requirements
Contents



Letter                                                                                            1


Appendix I                                                                                       28
                          Department of Agriculture                                              28
Examples of Federal       Department of Commerce                                                 29
Agencies' Certification   Department of Health and Human Services                                30
                          Department of Housing and Urban Development                            32
Requirements              Department of Labor                                                    32
                          Department of Transportation                                           33
                          Department of Veterans Affairs                                         36
                          Environmental Protection Agency                                        36


Appendix II                                                                                      38

GAO Contacts and
Staff
Acknowledgments




                          Page 24                          GAO/GGD-99-170 Certification Requirements
Contents




Abbreviations

AAR         Association of American Railroads
ABMS        American Board of Medical Specialties
AHA         American Heart Association
AMS         Agricultural Marketing Service
ANSI        American National Standards Institute
APHIS       Animal and Plant Health Inspection Service
ASME        American Society of Mechanical Engineers
BOS         Bureau of Osteopathic Specialists
CAP         College of American Pathologists
CDC         Centers for Disease Control and Prevention
CLIA        Clinical Laboratory Improvement Amendments
CPR         Cardiopulmonary resuscitation
DOT         Department of Transportation
EPA         Environmental Protection Agency
FAA         Federal Aviation Administration
FDA         Food and Drug Administration
HCFA        Health Care Financing Administration
HUD         Department of Housing and Urban Development
ICSP        Interagency Committee on Standards Policy
ILO         International Labor Organization
ISO         International Organization for Standardization
NAADAC      National Association of Alcoholism and Drug Abuse Counselors
NCCA        National Commission for Certifying Agencies
NIH         National Institutes of Health
NIST        National Institute of Standards and Technology
NMFS        National Marine Fisheries Service
NOAA        National Oceanic and Atmospheric Administration
NOCA        National Organization for Competency Assurance
NRTL        Nationally Recognized Testing Laboratory
NSF         NSF International (formerly the National Sanitation Foundation)
NSSP        National Shellfish Sanitation Program
NVCASE      National Voluntary Conformity Assessment System Evaluation Program
NVLAP       National Voluntary Laboratory Accreditation Program
NWS         National Weather Service
OGE         Office of Government Ethics
OMB         Office of Management and Budget
OSHA        Occupational Safety and Health Administration
RSPA        Research and Special Programs Administration (Transportation)
SAP         Substance abuse professional
SSCA        Shellfish Sanitation Control Authority
UL          Underwriters Laboratories, Inc.

Page 25                               GAO/GGD-99-170 Certification Requirements
Contents




USDA       United States Department of Agriculture
VA         Department of Veterans Affairs
WTO        World Trade Organization




Page 26                               GAO/GGD-99-170 Certification Requirements
Page 27   GAO/GGD-99-170 Certification Requirements
Appendix I

Examples of Federal Agencies' Certification
Requirements

                  This appendix briefly describes selected certification or certification-
                  related programs and requirements. Although not intended to provide a
                  compendium of all such federal agency programs or requirements, the
                  appendix illustrates both the number of federal certification requirements
                  and the dimensions by which they vary. To compile this appendix, we
                  relied primarily on examples identified by officials within the agencies that
                  we contacted during this review and information provided in the National
                  Institute of Standards and Technology (NIST) Directory of Federal
                                                                    1
                  Government Certification and Related Programs.

                • The U.S. Department of Agriculture’s (USDA) Agricultural Marketing
Department of     Service (AMS) provides voluntary on-site grading and certification of
Agriculture       meats and meat products through physical examination of product
                  characteristics during the production process. The required tests are
                  performed in government labs by AMS personnel, and approved USDA
                  stamps and roller brands are applied to products that are considered in
                  compliance with applicable standards or specifications. The grading
                  system provides a common language to facilitate trading, and the
                  certification assists large-scale buyers by providing impartial evaluation
                  and certification that meat purchases meet their contract specifications.
                  An AMS official also pointed out two related services provided under the
                  agency’s regulations. The Contract Verification Service provides
                  wholesale buyers of noncertified commodity products a method of
                  determining whether procurements meet contractually specified
                  requirements. The Quality Systems Certification Program provides meat
                  packers, processors, producers, or other businesses in the livestock and
                  meat trade the ability to have special processes or documented quality
                  management systems verified.
                • USDA’s AMS also issues certificates regarding the quality of other
                  agricultural products, including fresh fruits, vegetables, nuts, and related
                  products. All of these certifications are voluntary, except for commodities
                  that are regulated for quality by a marketing order or marketing
                  agreement, or that are subject to import or export requirements. AMS also
                  issues grade certificates for raw cotton, which are mandatory for cotton
                  delivered on futures contracts.
                • To assist in the export of plants and unprocessed plant products, USDA’s
                  Animal and Plant Health Inspection Service (APHIS) issues phytosanitary
                  (plant health) certificates to exporters certifying conformity with the
                  receiving country’s plant quarantine import regulations. The inspections

                  1
                   NIST SP–739, 4th Edition (Office of Standards Services, July 1999). NIST also publishes a separate
                  directory on laboratory accreditation programs, Directory of Federal Government Laboratory
                  Accreditation/Designation Programs (NIST SP–808).




                  Page 28                                             GAO/GGD-99-170 Certification Requirements
                  Appendix I
                  Examples of Federal Agencies' Certification Requirements




                  are conducted by federal and state cooperators, and testing is done in
                  federal and recognized state and university labs. APHIS also provides
                  export certificates, stamp endorsements, or letterhead certification to
                  indicate the class, quality, and condition of animal by-products to assist
                  exporters in the United States to comply with import requirements in
                  foreign countries.

                • The National Marine Fisheries Service (NMFS) within the Department of
Department of     Commerce’s National Oceanic and Atmospheric Administration (NOAA)
Commerce          inspects seafood products and processing operations on a voluntary, fee-
                  for-service basis. The inspections are performed by licensed federal and
                  state agents and involve vessel and plant sanitation, product inspection,
                  grading, certification, label review, and laboratory analysis. Federal, state,
                  and federally recognized private laboratories perform testing and analysis,
                  and NMFS lists approved suppliers and graded/certified products. Other
                  federal and state agencies, private organizations, foreign government
                  agencies, and international organizations recognize the NMFS seafood
                  certifications.
                • The National Weather Service (NWS) within NOAA administers a
                  mandatory program to certify weather observers and approve weather
                  stations. NWS certifies weather observers by examination and experience
                  for acceptable vision, adequate training, and demonstrated ability to take
                  and record accurate and timely weather observations. The stations are
                  approved on the basis of appropriate instrumentation use, installation of
                  automated sensors, maintenance programs, and certification of the
                  observers. The program ensures consistent, minimum performance
                  expectations for manual weather observations used for the preparation of
                  forecasts and warnings and the support of aviation operations.
                • The National Institute of Standards and Technology (NIST) administers the
                  National Voluntary Laboratory Accreditation Program (NVLAP). NVLAP
                  accredits laboratories on the basis of an evaluation of their technical
                  qualifications and competence to carry out specific calibrations or tests.
                  NVLAP accreditation is available to commercial; manufacturers’ in-house;
                  university; and federal, state, and local government laboratories and is
                  formalized through issuance of a Certificate of Accreditation and Scope of
                  Accreditation.
                • NIST also administers the National Voluntary Conformity Assessment
                  System Evaluation (NVCASE) program. The program’s primary objectives
                  are to provide a basis for the United States government to assure foreign
                  governments that qualifying conformity assessment bodies in the United
                  States (e.g., accreditors of laboratories) are competent to satisfy their
                  regulatory requirements and to facilitate the acceptance of American
                  products in foreign markets. The NVCASE program can also be applied in



                  Page 29                                      GAO/GGD-99-170 Certification Requirements
                         Appendix I
                         Examples of Federal Agencies' Certification Requirements




                         support of domestic regulatory programs at the request of another federal
                         agency. The NVCASE program includes activities related to laboratory
                         testing, product certification, and quality system registration. After
                         NVCASE evaluation, NIST provides recognition to qualified organizations
                         in the United States that effectively demonstrate conformance with
                         established criteria. NIST maintains listings of all recognized bodies, as
                         well as listings of qualified bodies that are currently accredited by bodies
                         recognized by NIST.

                       • In various procurement documents prepared by the Centers for Disease
Department of Health     Control and Prevention (CDC), the agency included certification
and Human Services       requirements for persons providing specific services. For example, a
                         medical officer had to be board-certified in one relevant primary care area
                         (such as internal medicine or surgery) and licensed to practice in the
                         United States or be board-eligible in both occupational medicine and
                         internal medicine. A physician’s assistant had to be certified or licensed as
                         a physician assistant by the appropriate national or state recognized
                         organization. A chief nurse, in addition to being registered as a registered
                         nurse in the state of Georgia, had to have annual certification in basic
                         cardiac life support. CDC also required that cardiopulmonary
                         resuscitation (CPR) instructors have American Heart Association (AHA)
                         certification as providers of basic and advanced cardiac life support or
                         American Red Cross Association certification plus AHA certification as (1)
                         Instructor in Basic Cardiac Life Support, (2) Instructor-Trainer in Basic
                         Cardiac Life Support, and (3) Instructor in Advanced Cardiac Life Support.
                       • The National Shellfish Sanitation Program (NSSP) is a federal-state
                         cooperative program recognized by the Food and Drug Administration
                         (FDA) and the Interstate Shellfish Sanitation Conference for the sanitary
                         control of shellfish (oysters, clams, mussels, and scallops) produced and
                         sold for human consumption. Most of the regulation, inspection,
                         investigations, and control measures are done at the state level. However,
                         FDA conducts an annual review of each state shellfish control program to
                         determine its degree of conformity with the NSSP. Annually, the state
                         Shellfish Sanitation Control Authority (SSCA) issues number certificates to
                         shellfish dealers who comply with sanitary standards and forwards copies
                         of the interstate certificates to FDA. FDA publishes a monthly list of all
                         shellfish shippers that have been certified by states that maintained
                         satisfactory control programs. Shellfish plants certified by SSCA are
                         required to place their certificate numbers on each container or package of
                         shellfish shipped. Separate from NSSP, FDA also issues certificates for
                         other fish and fishery products, including Certificates of Free Sale,
                         Certificates of Export, Certificates to Foreign Governments, and European
                         Union Health Certificates for Fishery Products.



                         Page 30                                      GAO/GGD-99-170 Certification Requirements
  Appendix I
  Examples of Federal Agencies' Certification Requirements




• FDA also has a mandatory certification program that lists approved color
  additives and the conditions under which they may be safely used in foods,
  drugs, cosmetics, and medical devices. Each batch of color must be tested
  and certified in an FDA laboratory before it can be used, unless the color
  additive is specifically exempted by regulation. Other federal agencies,
  state agencies, and private sector organizations recognize FDA’s
  certifications. However, under the provisions of the Federal Food, Drug,
  and Cosmetic Act, FDA cannot accept certification of a color by a foreign
  country as a substitute for its own certification.
• FDA’s Center for Devices and Radiological Health is responsible for the
  setting and enforcement of performance standards to control radiation
  emissions from electronic products, such as television receivers,
  microwave ovens, X-ray equipment, and lasers. A manufacturer of an
  electronic product for which there is an applicable federal performance
  standard is required to affix a certification label stating that the product
  conforms to the standard. Certification is based on a test prescribed by
  the standard or a testing program that is in accord with good
  manufacturing practices as determined by the Center. Manufacturers’ or
  third-party laboratories perform the testing.
• Under the Mammography Quality Standards Act of 1992, FDA was
  authorized to implement the act’s requirements for the certification and
                                               2
  inspection of all mammography facilities. Only certified facilities that are
  in compliance with uniform federal standards for safe, high quality
  mammography services may lawfully operate. These requirements apply
  to all facilities producing, processing, or initially interpreting
  mammograms, whether for screening or diagnostic purposes, except for
  facilities of the Department of Veterans Affairs, which developed its own
  quality assurance program. To become certified, facilities must first be
  accredited by an FDA-approved accreditation body. FDA published
  regulations to establish the requirements and standards for accrediting
  bodies and application procedures for such bodies. The FDA regulations
  also established the quality standards for mammography facilities and
  procedures for facility certification. Accreditation and certification must
  be renewed every 3 years.
• The Health Care Financing Administration (HCFA) regulates all laboratory
  testing (except research) performed on humans in the United States
  through the Clinical Laboratory Improvement Amendments (CLIA)
  program. CLIA certification is mandatory for all facilities that perform
  laboratory testing on specimens derived from the human body for the
  purpose of providing information for the diagnosis, prevention, or

  2
   The Mammography Quality Standards Reauthorization Act of 1998 extended this program until
  October 2002.




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                        Appendix I
                        Examples of Federal Agencies' Certification Requirements




                        treatment of disease, or impairment of or assessment of health. CLIA
                        regulations are based on the complexity of the test method—the more
                        complicated the test, the more stringent the requirements. Upon
                        determining compliance with regulatory requirements, HCFA issues the
                        appropriate certificate(s) for the type(s) of testing the laboratory
                        performs. Those certificates are effective for a 2-year period. Those
                        laboratories that must be surveyed routinely (those performing moderate-
                        or high-complexity testing) can choose whether to be surveyed by HCFA
                        or by a private accrediting organization. Approved accrediting
                        organizations under CLIA include the American Association for Blood
                        Banks, the American Osteopathic Association, the American Society for
                        Histocompatibility and Immunogenetics, the College of American
                        Pathologists, the Commission of Laboratory Accreditation, and the Joint
                        Commission on Accreditation of Healthcare Organizations. In addition,
                        certain laboratories are licensed under CLIA-exempt state programs in
                        New York, Oregon, and Washington.
                      • HCFA also has a survey and certification program covering providers and
                        suppliers of health care services to Medicare and Medicaid beneficiaries.
                        The aim of HCFA’s program is to ensure that these providers (such as
                        participating hospitals, home health agencies, and nursing home
                        providers) meet federal health, safety, and program standards. Hospitals
                        accredited by the Joint Commission on Accreditation of Healthcare
                        Organizations or the American Osteopathic Association are deemed to
                        participate in the program and meet federal requirements.

                      • The Department of Housing and Urban Development (HUD) has a
Department of Housing   voluntary program for validation of private sector certifications of building
and Urban               products for construction (i.e., that building products comply with
Development             designated standards). After testing by government accredited, third-party
                        validating, state/local, or manufacturers’ laboratories and inspection by
                        third parties, products that meet standards must have an authorized mark
                        or label affixed by the manufacturer or a third-party administrator.
                        Currently, 33 third-party administrators participate in the HUD Building
                        Products Certification program for such products as solid fuel-type
                        heaters, fireplace stoves, plastic bathtub units, aluminum windows, storm
                        doors, wood window units, carpet, and lumber, among others.
                      • HUD also has a mandatory program requiring third-party certification of
                        manufactured housing designs and quality assurance manuals, as well as
                        in-plant inspection to ensure compliance with standards. HUD issues lists
                        of approved third-party agencies.

                      • The Occupational Safety and Health Administration (OSHA) implements
Department of Labor     the Nationally Recognized Testing Laboratory (NRTL) Program. This



                        Page 32                                      GAO/GGD-99-170 Certification Requirements
                   Appendix I
                   Examples of Federal Agencies' Certification Requirements




                   program recognizes private sector organizations (third-party laboratories)
                   that meet the necessary qualifications specified in program regulations as
                   NRTLs. An NRTL determines that specific equipment and materials meet
                   consensus-based standards of safety to provide the assurance, required by
                   OSHA, that these products are safe for use in United States workplaces.
                   To obtain initial NRTL recognition, an applicant must complete an
                   application and resolve any deficiencies found during an on-site
                   assessment. A preliminary notice is then published in the Federal Register
                   announcing the application for recognition, a 60-day comment period
                   ensues, and (absent compelling reasons to the contrary), a final notice is
                   published formally recognizing the applicant as an NRTL.
                 • In another program, OSHA also accredits independent third-party
                   certification agencies for the purpose of certifying maritime vessels’ cargo
                   gear lifting and handling gear and shore-based cargo handling equipment.
                   OSHA maintains a list of accredited certification agencies and surveyors.
                   The certifications are intended to ensure that all covered equipment is in a
                   safe material condition, properly tested, and in compliance with regulatory
                   requirements. Through this program, the United States fulfills its
                   responsibilities under International Labor Organization (ILO) Convention
                   No. 152.

                 • Regulations on substance abuse prevention that cover employees in
Department of      Department of Transportation (DOT)-regulated transportation industries
Transportation     (including aviation, highway, rail, and other transit industries, such as
                   pipelines) include provisions requiring face-to-face evaluation by
                   substance abuse professionals. DOT defines these professionals as
                   including, among others, a licensed or certified psychologist or an
                   addiction counselor certified by the National Association of Alcoholism
                   and Drug Abuse Counselors Certification Commission or by the
                   International Certification Reciprocity Consortium/Alcohol & Other Drug
                   Abuse.
                 • Testing and/or inspection by a Coast Guard accredited laboratory is
                   mandatory for some equipment required for use on recreational boats and
                   commercial vessels (e.g., equipment used for lifesaving, fire protection,
                   and pollution prevention, as well as other electrical and engineering
                   equipment). Manufacturer self-certification is allowed for selected items.
                 • The Coast Guard issues certificates of approval to certain providers of
                   merchant marine courses. Obtaining a certificate is mandatory where
                   required by regulations (in areas such as radar observation, fire fighting,
                   and first aid), but it is otherwise voluntary. Training organizations seeking
                   approval must submit course packages to the Coast Guard’s National
                   Maritime Center, the proposed training facility is inspected by a Coast




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  Appendix I
  Examples of Federal Agencies' Certification Requirements




  Guard Regional Examination Center, and instructor qualifications are
  reviewed.
• The Coast Guard issues certificates of inspection for certain vessels
  following satisfactory completion of an inspection by a government body
  or an organization recognized by the Coast Guard. A 1997 final rule
  provided for the alternative to Coast Guard inspection by permitting the
  Coast Guard to issue a certificate of inspection based upon reports by a
  “recognized, authorized classification society.” The Coast Guard generally
  establishes the procedures and standards used in inspections, but some
  are also established by statute or through international conventions and
  treaties for certain vessels. Other federal agencies, foreign government
  agencies, and international organizations recognize these certificates.
• The Coast Guard also enforces requirements to ensure the safety of
  shipping containers used for the international transport of cargo. A third
  party must certify these containers before they enter into international
  traffic. The certifications are mandatory under the International Safe
  Container Act and signify that the containers conform to the International
  Convention for Safe Containers. Foreign governments and international
  organizations recognize this certification. Containers must display a Safety
  Approval Plate from the approval authority in the country of registry.
• The Federal Aviation Administration (FAA) has a comprehensive system of
  certifications for the civil aviation system, with coverage ranging across
  equipment, personnel, and facilities. For example, FAA issues Type
  Certificates for makes and models of aircraft, aircraft engines, or
  propellers and grants Airworthiness Certificates for specific aircraft that
  meet approved type designs and are in condition for safe operation. FAA
  provides certification for pilots, flight instructors, crew members,
  mechanics, control tower operators, and other aviation-related personnel.
  FAA also provides for certification of repair stations, parachute lofts, and
  schools for pilots and mechanics. FAA operates an Airport Safety and
  Certification Program and an Airport Lighting Equipment Certification
  program. It issues certificates of designation and certificates of authority
  to, among others, aviation medical examiners, examiners of pilots and
  technical personnel, designated engineering representatives, and
  manufacturing inspection representatives. Compliance with the FAA
  certification system is mandatory for civil aviation, and the Department of
  Defense and the Coast Guard also require that some of their aircraft and
  equipment be FAA-certified. Most of the applicable design, performance,
  and quality requirements are specified in the Code of Federal Regulations.
  The International Civil Aviation Organization also sets general guidelines
  for airworthiness certification systems that FAA implements in the United
  States. In addition, FAA accepts some nongovernment standards, such as
  ones developed by the Society of Automotive Engineers, the Radio



  Page 34                                      GAO/GGD-99-170 Certification Requirements
    Appendix I
    Examples of Federal Agencies' Certification Requirements




    Technical Commission for Aeronautics, and the Aerospace Industries
    Association.
•   The Federal Railroad Administration has a number of safety-related
    certification programs. One mandatory program covers safety glazing of
    windows for locomotives, passenger cars, and cabooses. Testing of
    glazing materials to demonstrate compliance with regulatory requirements
    is done by either manufacturers in their labs or independent labs that meet
    specified qualifications. Each individual unit of glazing material is
    permanently marked to indicate certification.
•   A voluntary program administered by DOT’s Research and Special
    Programs Administration (RSPA) covers packaging of hazardous materials
    for export. Shippers and container manufacturers can demonstrate
    conformance of their packaging designs with United Nations’ standards
    through third-party testing agencies designated by RSPA’s Office of
    Hazardous Materials Technology. These third-party approval agencies
    evaluate and issue approval certificates for intermodal portable tanks and
    certificates of conformance for other types of packaging.
•   RSPA also has a mandatory requirement for third-party certification of
    railway tank cars used for the transport of hazardous materials. The third
    parties must be acceptable to the Association of American Railroads
    (AAR) and the Bureau of Explosives. AAR provides design approval of
    couplers, which is accepted by DOT. RSPA issues certificates of
    construction.
•   Another RSPA mandatory program requires registration of all persons or
    organizations engaged in the manufacture, assembly, inspection and
    testing, certification, or repair of cargo tanks or cargo tank motor vehicles.
    Manufacturers of special cargo tanks and cargo tank motor vehicles must
    also obtain an American Society of Mechanical Engineers (ASME)
    Certificate of Authorization for the use of the ASME “U” stamp. Repairs
    that are not verified to the ASME Code must have a National Board or
    ASME Certificate of Authorization. ASME or ASME-designated bodies
    perform the required testing or inspection. Other federal agencies, state
    agencies, private sector organizations, and the Canadian government
    recognize reciprocity with this registration.
•   RSPA requires third-party certification of welders and plastic pipe
    assemblers to ensure the safety of pipelines for gas and hazardous liquids.
    The agency also requires manufacturers’ self-certification for valves,
    pressure-limiting services, and overall installation to specified standards.
    Certification of welders is usually conducted by the American Welding
    Society, but a comparable program by the installing contractor may be
    acceptable to RSPA. The agency adopts the standards of national
    standards organizations.




    Page 35                                      GAO/GGD-99-170 Certification Requirements
                      Appendix I
                      Examples of Federal Agencies' Certification Requirements




                    • The Department of Veterans Affairs (VA) requires certification of
Department of         automotive driving aids and automatic wheelchair lifts for purchases
Veterans Affairs      funded by the Department. VA publishes a compliance list that delineates
                      certified suppliers of wheelchair lift systems and hand controls (driving
                      aids). Certification is by a VA-sponsored Automobile Adaptive Equipment
                      Committee. Government testing and inspection, third party government-
                      approved certification (Society of Automotive Engineers), and
                      manufacturers’ self-certification are used to ensure compliance with VA’s
                      standards. VA also accepts certification by other agencies when current
                      standards are applied.
                    • VA has similar mandatory requirements for self-propelled and motorized
                      wheelchair purchases funded by the department, again listing suppliers of
                      these products. Certification is by a VA-sponsored Prosthetic Technology
                      Equipment Committee. Government testing and inspection, third party
                      government-approved certification (Rehabilitation Engineering and
                      Assistive Technology Society of North America/ANSI), and manufacturers’
                      self-certification are used to ensure compliance with VA’s standards. VA
                      also accepts certification by other agencies when current standards are
                      applied.
                    • In order to ensure standardization and uniformity in laboratory test
                      performance throughout the VA system’s clinical, nuclear medicine, and
                      special purpose ancillary testing laboratories, the department requires
                      third-party certification by the College of American Pathologists (CAP) and
                      the Joint Commission on Accreditation of Healthcare Organizations. The
                      standards applied are those of the CAP Laboratory Accreditation Program,
                      but VA also recognizes certification by the Joint Council of American
                      Hospitals.
                    • VA established board certification requirements that, with some
                      exceptions, applied to physicians hired on or after July 1, 1997. Unless
                      they have written approval of the Chief Patient Care Services Officer prior
                      to appointment, these physicians must be board-certified in the clinical
                      specialty area in which they will practice. VA’s Undersecretary for Health
                      specified that the certifying bodies for these purposes are the American
                      Board of Medical Specialties (ABMS) for allopathic physicians and the
                      Bureau of Osteopathic Specialists (BOS) for osteopathic physicians.

                    • An Environmental Protection Agency (EPA)-accredited, third-party
Environmental         laboratory must conduct emissions testing for certification of new
Protection Agency     residential wood heaters and submit the results to EPA. EPA certifies a
                      representative wood heater from the model line, granting certificates valid
                      for 5 years.
                    • In another mandatory program, laboratories performing drinking water
                      analysis to demonstrate compliance with regulations must be certified as



                      Page 36                                      GAO/GGD-99-170 Certification Requirements
  Appendix I
  Examples of Federal Agencies' Certification Requirements




  capable of delivering acceptable performance. States seeking to operate a
  drinking water regulatory program must implement a laboratory
  certification program based on federal standards. EPA’s regional offices
  serve as the certifiers in situations where there is no approved state
  program. Certified laboratories are issued certificates identifying areas of
  competency.
• To ensure that pesticides posing relatively high risk, or that are difficult to
  use, are used only by or under the direct supervision of competent
  persons, EPA oversees state programs to certify applicators. EPA serves
  as the certifier of applicators in Colorado. An applicator may not apply
  restricted-use pesticides until he or she demonstrates competency and
  receives certification.
• Under section 609 of the Clean Air Act Amendments of 1990, operators
  who service motor vehicle air conditioners must be certified under an
  approved 609 program prior to offering services. EPA restricts the sale of
  small containers of Class I and Class II substances appropriate for use in
  motor vehicle air conditioners to certified personnel. Personnel testing is
  done by private industry programs approved by EPA. Also, recovery and
  recycling equipment must be approved by EPA and must meet the
  requirements of the SAE standards for approval. EPA maintains a list of
  technician certification programs and approved equipment.




  Page 37                                      GAO/GGD-99-170 Certification Requirements
Appendix II

GAO Contacts and Staff Acknowledgments


                  Curtis Copeland, (202) 512-8101
GAO Contacts      Tim Bober, (202) 512-4432



                  In addition to those named above, Alan Belkin, John Brosnan, and Victor
Acknowledgments   B. Goddard made key contributions to this report.




                  Page 38                              GAO/GGD-99-170 Certification Requirements
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