Certification Requirements: New Guidance Should Encourage Transparency in
Agency Decisionmaking (Letter Report, 09/24/1999, GAO/GGD-99-170).
Pursuant to a congressional request, GAO reviewed federal agencies'
certification requirements for goods and services, focusing on: (1) the
extent and variety of certification activities in the federal
government; (2) the extent to which there are policies, procedures, or
guidance governing those activities, either governmentwide or within
selected agencies; and (3) an agency certification procedure that could
serve as an example or best practice for other agencies.
GAO noted that: (1) federal agencies engage in a large number and wide
variety of certification-related activities; (2) 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, accreditation, listing, or
registration; (3) these directories provide only a partial inventory of
agencies' activities because they focus primarily on certifications of
products and services and they do not cover individual procurement
actions in which agencies require particular certifications; (4)
certification activities also vary across multiple dimensions, including
the origin of the requirements, their targets, which 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 requirements; (5) specific guidance regarding the
selection of specific requirements or certifying organizations is
limited; (6) federal procurement law imposes some limits on agencies'
use of certification requirements, restricting the use of certification
requirements to instances in which the requirements are specifically
imposed by law or the agencies show a particular need and, if possible,
allow for alternatives; (7) 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; (8) there is no governmentwide
guidance, or agencywide guidance in the five agencies that GAO reviewed,
regarding all types of certification requirements; (9) NIST has prepared
draft guidance on conformity assessment activities, including
certification, which it plans to issue for public comment; (10) one best
practice that GAO has supported in the regulatory arena, transparency of
decisionmaking, also appears applicable to certification requirements,
particularly given the complexity and diversity of certification
activities and organizations; (11) in the certification actions that GAO
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; (12) other agencies'
certification actions were not as transparent and certification bodies
that were not selected raised questions about the criteria that agencies
used; and (13) in each of those cases, agency officials were able to
provide the rationale for their actions.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: GGD-99-170
TITLE: Certification Requirements: New Guidance Should Encourage
Transparency in Agency Decisionmaking
DATE: 09/24/1999
SUBJECT: Procurement
Product evaluation
Reporting requirements
Private sector practices
Institution accreditation
Standards and standardization
Federal procurement
IDENTIFIER: OSHA Nationally Recognized Testing Laboratory Program
NMFS Voluntary Seafood Inspection Program
FDA Mammography Certification Program
******************************************************************
** This file contains an ASCII representation of the text of a **
** GAO report. This text was extracted from a PDF file. **
** Delineations within the text indicating chapter titles, **
** headings, and bullets have not been preserved, and in some **
** cases heading text has been incorrectly merged into **
** body text in the adjacent column. Graphic images have **
** not been reproduced, but figure captions are included. **
** Tables are included, but column deliniations have not been **
** preserved. **
** **
** Please see the PDF (Portable Document Format) file, when **
** available, for a complete electronic file of the printed **
** document's contents. **
** **
** A printed copy of this report may be obtained from the GAO **
** Document Distribution Center. For further details, please **
** send an e-mail message to: **
** **
** **
** **
** with the message 'info' in the body. **
******************************************************************
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 organization that the
product is safe.1 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 1Underwriters
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. Page 1
GAO/GGD-99-170 Certification Requirements B-281675 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, accreditation, listing, or registration.2 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. 2Congress 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. Page 2
GAO/GGD-99-170 Certification Requirements B-281675 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 of certification activities and organizations in the
United States.3 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 terms for
accreditation, with at least 18 different meanings. 4
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
3See, 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). 4Laboratory Accreditation:
Requirements Vary Throughout the Federal Government (GAO/RCED-89-
102, Mar. 28, 1989). Page 3
GAO/GGD-99-170 Certification Requirements B-281675 services are
fit for their purpose.5 ISO defines certification as the procedure
by which a third party gives written assurance that a product,
process, or service conforms to specified requirements or
standards. Accreditation, according to ISO, refers to the
procedure by which an authoritative body gives formal recognition
that a body or person is competent to carry out specific tasks. In
the context of certification, an accreditation body might accredit
a certification body, such as a testing laboratory, as competent
to carry out certification activities-in a sense, certifying the
certifiers. Recognition is a term that is relatively new to
conformity assessment activities in the United States, and it
refers to designation by a government entity that an accreditation
program is competent. Conformity assessment is the broadest term
for these types of activities. According to the National Academy
of Sciences, conformity assessment is the determination of whether
a product or process conforms to particular standards or
specifications. It may include such activities as sampling,
testing, inspection, certification, registration, accreditation,
and recognition. There are a great many standards or criteria for
product quality, process Numerous Standards 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. Page 4
GAO/GGD-99-170 Certification Requirements B-281675 the
qualifications and competence of individuals in specific
disciplines or fields. The preceding examples also illustrate that
standards can come from many sources. They can be established by
industry or professional consensus standard-setting bodies, by
governments through statutes or regulations, or by international
standard-setting bodies. Certifications of products, processes,
and services provide information on Certifications Reflect
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 certification or accreditation of individuals.6 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. 6NOCA is a private sector national umbrella
organization in the area of certification. Page 5
GAO/GGD-99-170 Certification Requirements B-281675 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 Page 6
GAO/GGD-99-170 Certification Requirements B-281675 accreditation,
recognition, and conformity assessment, the report does not cover
those Federal Acquisition Regulation certifications (e.g., the
Certification of Final Indirect Costs and the Certification of
Nonsegregated Facilities) that might be included as standard
solicitation provisions and contract clauses but are not related
to conformity with technical or professional standards.7 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 entity or entities do the certifying, whether
the certifications are Certification-Related 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. 7See 41 U.S.C. 425(c) for limitations on the use of
requirements for certification by offerors or contractors in the
Federal Acquisition Regulation. Page 7
GAO/GGD-99-170 Certification Requirements B-281675 We did not
attempt to develop a compendium of every federal agency Federal
Certification 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 B-281675 * 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 B-281675 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 biohazard cabinet field
certifiers."8 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 rulemaking and procurement
can serve a useful role in notifying the public Certification
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. The Competition in Contracting Act
of 1984 provides that a solicitation for Procurement Law Sets
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 8NSF 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. Page 10
GAO/GGD-99-170 Certification Requirements B-281675 product
involved, the regulations also say that the requirements must not
indicate that only one laboratory's certificate will be
acceptable.9 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 approvals.10 The
absence of an endorsement by a particular private organization
should not automatically exclude offers that would otherwise meet
a procuring agency's needs. These procurement provisions
notwithstanding, there is little in the way of Certification
Guidance Is 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. Page 11
GAO/GGD-99-170 Certification Requirements B-281675 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 Commerce on conformity assessment
activities, including certification.11 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.
Although there is currently no governmentwide guidance
specifically on Related Policies and 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- 11ICSP 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 B-281675 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 or otherwise impractical. 12 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 selected that standard as a
requirement.13 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 12OMB 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 B-281675 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 Counselors (NAADAC) Certification
Commission could serve as SAPs.14 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
14Subsequently, 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. Page 14
GAO/GGD-99-170 Certification Requirements B-281675 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 than attempting to develop criteria for
selecting among these procedures, Decisionmaking Is a 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 B-281675 The transparency of the agency
certification actions that we reviewed Transparency of Agency
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 requirements for vessel
inspection and certification.15 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 society to meet 23
specific criteria.16 15See 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. 16For 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 B-281675 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
did not indicate why these organizations were selected.17 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 17VA 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 B-281675 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. Page 18 GAO/GGD-99-170
Certification Requirements B-281675 Agencies can make clear the
criteria they used or plan to use to select a Common Criteria Used
to 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). However, transparency is not free.
The Director of CDC's Procurement Transparency Is Not Free or 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 B-281675 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 B-281675 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 B-281675 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 1 Letter 28 Appendix I
Department of Agriculture
28 Examples of Federal Department of Commerce
29 Department of Health and Human Services
30 Agencies' Certification 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 38 Appendix II 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 Government
Certification and Related Programs.1 * 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 SP739, 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 SP808). 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 inspection of all mammography facilities.2
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. Page 31
GAO/GGD-99-170 Certification Requirements 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 Page 33
GAO/GGD-99-170 Certification Requirements 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 Page 39 GAO/GGD-99-
170 Certification Requirements Page 40 GAO/GGD-99-170
Certification Requirements Ordering Information The first copy of
each GAO report and testimony is free. Additional copies are $2
each. Orders should be sent to the following address, accompanied
by a check or money order made out to the Superintendent of
Documents, when necessary. VISA and MasterCard credit cards are
accepted, also. Orders for 100 or more copies to be mailed to a
single address are discounted 25 percent. Order by mail: U.S.
General Accounting Office P.O. Box 37050 Washington, DC 20013 or
visit: Room 1100 700 4th St. NW (corner of 4th and G Sts. NW) U.S.
General Accounting Office Washington, DC Orders may also be placed
by calling (202) 512-6000 or by using fax number (202) 512-6061,
or TDD (202) 512-2537. Each day, GAO issues a list of newly
available reports and testimony. To receive facsimile copies of
the daily list or any list from the past 30 days, please call
(202) 512-6000 using a touch- tone phone. A recorded menu will
provide information on how to obtain these lists. For information
on how to access GAO reports on the INTERNET, send e-mail message
with "info" in the body to: [email protected] or visit GAO's World
Wide Web Home Page at: http://www.gao.gov United States General
Accounting Office Bulk Rate Washington, D.C. 20548-0001
Postage & Fees Paid GAO Permit No. G100 Official Business Penalty
for Private Use $300 Address Correction Requested (410364)
*** End of document. ***