CERTIFICATION

REQUIREMENTS

New Guidance Should

Encourage

Transparency in

Agency

Decisionmaking

United States General Accounting Office

GAO Report to the Chairman,

Committee on Small Business

House of Representatives

September 1999

GAO/GGD-99-170

United States General Accounting Office General Government Division

Washington, D.C. 20548

Page 1 GAO/GGD-99-170 Certification Requirements

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

 

1

Underwriters Laboratories, Inc. (UL) is an independent, not-for-profit product safety testing and

certification organization. A “UL” mark on a product indicates that UL found that samples of the

product met UL’s safety requirements. The marks are commonly found on appliances, computer

equipment, heaters, fuses, and other products.
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Page 2 GAO/GGD-99-170 Certification Requirements

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

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.

 

2

Congress established NIST (formerly the National Bureau of Standards) in 1901 to support industry,

commerce, scientific institutions, and all branches of the government. It is an agency of the

Department of Commerce, and its primary mission is to promote economic growth in the United States

by working with industry to develop and apply technology, measurements, and standards.

Results in Brief
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One “best practice” that we have supported in the regulatory arena—

transparency of agency decisionmaking—also appears applicable to

certification requirements, particularly given the complexity and diversity

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

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

 

3

See, for example, Regulatory Reform: Changes Made to Agencies’ Rules Are Not Always Clearly

Documented (GAO/GGD-98-31, Jan. 8, 1998); and Dietary Supplements: Uncertainties in Analyses

Underlying FDA’s Proposed Rule on Ephedrine Alkaloids (GAO/HEHS/GGD-99-90, July 2, 1999).

4

Laboratory Accreditation: Requirements Vary Throughout the Federal Government (GAO/RCED-89-

102, Mar. 28, 1989).

Background
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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

reliability, or professional competence. NIST estimated that in the United

States alone, approximately 49,000 voluntary standards have been

developed by more than 620 organizations. The agency said this estimate

does not include “a much greater number of procurement specifications. . .

as well as mandatory codes, rules, and regulations containing standards

developed and adopted at federal, state, and local levels.” NIST also

pointed out that numerous foreign, regional, and international

organizations produce standards of interest and importance to American

businesses. For example, ISO has issued more than 10,000 international

standards. Agency officials told us that use of these and other international

standards has become increasingly common in the United States.

The standards underlying certifications cover a wide range of products,

processes, and professions. Some are product quality or safety standards,

such as the American National Standards Institute (ANSI) standard for

manually operated gas valves or the UL standard for communications

cables. There are also standards for the performance and reliability of

particular processes, as in ISO standards for quality management systems.

Professional standards, such as the American Medical Association’s

standards in medical practice, research, and education, are used to assure

 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.

Numerous Standards

Underlie Certifications
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the qualifications and competence of individuals in specific disciplines or

fields. The preceding examples also illustrate that standards can come

from many sources. They can be established by industry or professional

consensus standard-setting bodies, by governments through statutes or

regulations, or by international standard-setting bodies.

Certifications of products, processes, and services provide information on

whether they can meet certain levels of quality, safety, or performance.

However, certifications of people or organizations focus on an evaluation

and designation of competence and qualifications. In professional and

technical fields, certifications confirm the skills and knowledge of

individuals who meet specific requirements (e.g., a certified public

accountant). The professional certification process typically involves

passing examinations and meeting other educational and/or experiential

requirements. The choice of standards, the type of certification program,

and the certification methodology used to assess conformity all have a

significant impact on the validity and value of the information provided by

a given certification.

The total number of certification programs in the United States is

unknown, but NIST has identified at least 178 private sector organizations

that have product certification programs. In addition, the National

Organization for Competency Assurance (NOCA) has identified at least

1,700 organizations based in the United States with programs for the

certification or accreditation of individuals.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.

 

6

NOCA is a private sector national umbrella organization in the area of certification.

Certifications Reflect

Diversity of Standards
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Congress has attempted to address some of the concerns about redundant

certification requirements. For example, the Technology Transfer and

Advancement Act of 1995 requires greater coordination of conformity

assessment activities and attempts to facilitate mutual recognition among

conformity assessment programs. Also, in June 1999 Congress amended

the Fastener Quality Act in part to address concerns about potentially

burdensome, costly, and duplicative testing and certification procedures

that would have been imposed on industry. The amended law no longer

requires NIST to approve organizations that accredit fastener testing

laboratories. The amendments also exempt those fasteners already subject

to the Federal Aviation Administration’s (FAA) regulation.

However, despite such concerns, it also should be recognized that some

certification programs and requirements foster opportunities for small

businesses. For example, the Nationally Recognized Testing Laboratory

(NRTL) Program implemented by the Occupational Safety and Health

Administration (OSHA) recognizes private sector laboratories that meet

the necessary qualifications specified in program regulations. OSHA

officials pointed out that this program has given a number of small testing

laboratories in the United States the opportunity to provide types of

services that only a few organizations provided before the program went

into effect.

Our objectives in this review were to describe (1) the extent and variety of

certification activities in the federal government; (2) the extent to which

there are policies, procedures, or guidance governing those activities,

either governmentwide or within selected agencies; and (3) an agency

certification procedure that could serve as an example or “best practice”

for other agencies. To address these objectives, we interviewed officials

and obtained documentation from five federal agencies in which the

Committee had expressed an interest: the Departments of Transportation

(DOT) and Veterans Affairs (VA); and, within the Department of Health

and Human Services, the Centers for Disease Control and Prevention

(CDC), FDA, and the National Institutes of Health (NIH). We also

contacted officials in the Office of Management and Budget’s (OMB) Office

of Information and Regulatory Affairs, NIST, and the Office of Government

Ethics (OGE) because of their responsibilities related to the issue of

certification. We also interviewed and obtained documents from officials

of NOCA and its related accreditation body, the National Commission for

Certifying Agencies (NCCA).

There are some important scope limitations to our review. Although we

defined the term certification broadly to include such issues as

Objectives, Scope, and

Methodology
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Page 7 GAO/GGD-99-170 Certification Requirements

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 agencyspecific policies, procedures, or guidance under the second objective was

limited to selected agencies, including CDC, DOT, FDA, NIH, and VA. To

address our third objective, we again focused primarily on specific

certification examples from the five selected agencies. The examples cited

in agencies other than the five selected for more in-depth review were

limited to ones cited in published reports or suggested by persons we

interviewed. We obtained only limited information on the certification

requirements in agency procurement actions. Our choices of examples to

highlight as best practices represent subjective decisions based on our

observations and work in the regulatory arena.

We conducted this review between November 1998 and August 1999 at the

headquarters offices of the above-mentioned agencies in the Washington,

D.C., area in accordance with generally accepted government auditing

standards. We provided a draft of this report to the Secretaries of

Commerce, Health and Human Services, Transportation, and Veterans

Affairs and the Director of OMB for their review and comment. Their

responses are presented at the end of this letter, along with our evaluation.

Federal agencies engage in both a large number and a wide variety of

certification-related activities. The certifications differ across several

dimensions, including the origins of the requirements, their targets, which

entity or entities do the certifying, whether the certifications are

mandatory or voluntary, and the extent to which there is reciprocity with

or recognition of other certifications or other organizations’ requirements.

The extent of agency involvement in the process can also vary, ranging

from instances in which an agency might simply apply a certification

requirement established by other entities to cases in which the agency is

actively involved in developing and enforcing a specific requirement.

 

7

See 41 U.S.C. 425(c) for limitations on the use of requirements for certification by offerors or

contractors in the Federal Acquisition Regulation.

Agencies Engage in a

Wide Variety of

Certification-Related

Activities
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Page 8 GAO/GGD-99-170 Certification Requirements

We did not attempt to develop a compendium of every federal agency

certification or certification-related activity and requirement, and it would

be difficult to do so given the absence of a common understanding and

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

Federal Certification

Activities Are Numerous

and Diverse
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Page 9 GAO/GGD-99-170 Certification Requirements

• 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
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Page 10 GAO/GGD-99-170 Certification Requirements

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

certification requirements used in federal procurement. In addition, agency

officials pointed out that their general procedures and practices for

rulemaking and procurement can serve a useful role in notifying the public

and soliciting feedback on proposed certification requirements. However,

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

a government contract may include a restrictive provision only to the

extent that the provision is authorized by law or is necessary to satisfy the

agency’s needs. Some agency-specific acquisition regulations mirror the

Competition in Contracting Act’s limitations on the use of unnecessarily

restrictive certification requirements. For example, VA’s regulations allow

requirements that offerors conform to technical standards that are

generally recognized and accepted in the industry involved. However, if

there is a choice of laboratories available to certify the quality of the

 8

NSF refers to NSF International, founded in 1944 as the National Sanitation Foundation. NSF is an

independent, not-for-profit organization active in standards development and certification programs

related to public health safety and protection of the environment.

Little Guidance Exists

on Agency

Certification

Requirements

Procurement Law Sets

Some Boundaries on

Certification Requirements
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Page 11 GAO/GGD-99-170 Certification Requirements

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

general policies, procedures, or criteria governing how agencies should

proceed in establishing certification requirements or selecting certifying

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.

Certification Guidance Is

Currently Limited to

Specific Programs
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NIST has taken a first step toward developing governmentwide

certification guidance. In response to requirements in the National

Technology Transfer and Advancement Act of 1995 and OMB Circular A119, 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

certification requirements, agency officials noted several related policies

and procedures that can affect those requirements. Those policies and

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.

NIST Has Developed Draft

Certification Guidance

Related Policies and

Procedures Also Affect

Certification Requirements
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interest laws, and agencies’ rulemaking and procurement procedures and

regulations.

OMB Circular A-119 says that all federal agencies must use voluntary

consensus standards in lieu of government-unique standards in their

procurement and regulatory activities, except where inconsistent with law

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 A119, 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.
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unnecessary obstacles to trade. The agreement includes articles regarding

procedures for assessment of conformity and recognition of conformity

assessment by central government bodies. For example, the agreement

encourages countries to recognize each other’s testing procedures.

Members of WTO are also encouraged to permit conformity assessment

bodies located in the territories of other members to participate in their

conformity assessment procedures under conditions no less favorable than

those accorded to bodies within their own territories or the territories of

any other countries.

Agency officials also said that their general procedures and regulations

governing rulemaking and procurement play an important role in

certification activities. In particular, they noted that such procedures and

regulations provide valuable opportunities for an agency to inform the

public and solicit feedback on proposed certification requirements. FDA

officials said their agency’s procedural rules and regulations require them

to use rulemaking in order to establish an enforceable certification

requirement.

DOT and FDA used the rulemaking process in developing or implementing

several of the agencies’ certification requirements. Although DOT and FDA

officials acknowledged that rulemaking procedures take considerable time

and effort, they noted that those procedures could also help the agencies

obtain informed comments and document certification decisions. DOT

officials said the use of the rulemaking process was particularly valuable in

the establishment of certification requirements for subjects that are new to

the department or in which DOT has little expertise. For example,

proposed departmental regulations intended to reduce alcohol misuse by

employees in DOT-regulated transportation industries included important

roles for substance abuse professionals (SAPs). In response to public

comments on the proposed rule, DOT refined and expanded its definition

of SAPs in the final regulations and said alcohol and drug abuse counselors

certified by the National Association of Alcoholism and Drug Abuse

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.
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to act through nonmandatory guidance or recommendations, not through

rulemaking. DOT officials said that they generally do not use rulemaking

procedures if certification requirements are part of a one-time

procurement or contract. However, they said rulemaking might be the

appropriate approach if the requirements are part of a recurring

procurement.

Agency officials also noted that procurement procedures can play a role in

their agencies’ choice of certification requirements and certifying

organizations. Contracting officials emphasized the opportunities provided

throughout the procurement process for prospective bidders to question

proposed certification requirements and to suggest changes or other

equivalent certifications that might meet the agency’s needs. NIH officials

noted that in addition to responding to the solicitation itself, bidders can

comment on the draft request for proposal (published to see if there are

enough sources) and the announcement of forthcoming solicitations to the

market that appears in the Commerce Business Daily. Officials from CDC,

FDA, and NIH pointed out that any solicitation could be the subject of bid

protests if their agencies used procurement provisions that some entities

believed were too restrictive.

As noted previously, agency certification actions are numerous and vary

substantially. Therefore, specification of a particular certification “best

practice” would likely depend on the context of the certifications. Rather

than attempting to develop criteria for selecting among these procedures,

we focused on one practice that we have supported in the regulatory

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.

Transparency of

Certification

Decisionmaking Is a

“Best Practice”
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The transparency of the agency certification actions that we reviewed

varied dramatically. In some instances, the agencies clearly documented

the criteria that they used or planned to use to select particular

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.

Transparency of Agency

Certification Requirements

Varies
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In DOT’s previously mentioned substance abuse-prevention program, the

department’s rulemaking notices clearly documented the department’s

reasons for selecting or rejecting particular certifying bodies. Although

DOT did not describe the specific criteria it would use to accept or reject

professional certifications at the time it issued the proposed rule, the

department’s response to public comments in the final rule clearly

described why it accepted certification by NAADAC and rejected state

certifications. DOT noted that NAADAC was a national organization and

that commenters provided information showing that the training and

experience needed to meet NAADAC standards and certification

requirements were sufficient for participation as a SAP in DOT’s alcohol

misuse prevention programs. DOT said it rejected suggestions that the SAP

definition include state-certified counselors because qualification

standards varied dramatically by state and did not always result in statecertified 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.
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BOS are “the standard certifying organizations recognized throughout

American medicine.” However, VA did not further describe why it selected

these two certifying organizations.

VA officials told us during this review that they rely on consensus

practices and standards of the health care profession in establishing

certification requirements. They said VA’s use of ABMS and BOS

certifications can be traced back to a 1980 decision by the Chief Medical

Director to accept ABMS and BOS physician board certifications for

Incentive Special Pay purposes. In 1997, VA extended those same

certifications that were required for special pay purposes to employment,

“grandfathering” currently employed physicians. VA officials also noted

that they had canvassed other federal agencies involved in health care

issues—including the Department of Defense, the Public Health Service,

NIH, CDC, and the Bureau of Prisons—and found that essentially all

recognized ABMS and BOS as the two accepted organizations for board

certification purposes. The officials also described to us some of their

expectations of a health professional certification program—in essence,

informal selection criteria. These included (1) accreditation for

educational requirements (undergraduate, medical school, and residency

program); (2) accreditation for post-residency experience; and (3)

certifying exams in the area of specialty. Finally, they pointed out that by

law, the Secretary for Veterans Affairs has special authority to make

personnel decisions. Although the description that VA officials provided

explains how ABMS and BOS were selected, it was not contained in any

published document and did not explain what criteria other organizations

would need to meet to be accepted by VA.

Another agency certification decision that was not transparent to affected

entities involved a 1996 NIH solicitation for the maintenance, certification,

and decontamination of certain types of facilities and equipment, including

biological safety cabinets. NIH implicitly designated NSF International as

the sole certifying organization by including a requirement in the

solicitation that the full-time on-site supervisor for specific locations be an

NSF-accredited biohazard cabinet field certifier. NIH did not explain why

only NSF accreditation was acceptable. As in the VA example, other

certifying organizations that were not designated raised questions about

the restriction to NSF’s program. NIH officials told us during our review

that NSF had the only accreditation program that was nationally

recognized. The officials also pointed out that they applied the restrictive

provision as narrowly as possible—requiring accreditation only for

supervisors—while still addressing the agency’s primary need to protect

the safety of NIH personnel.
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Agencies can make clear the criteria they used or plan to use to select a

particular certification requirement or certifying organization in any

number of ways. However, those cases that we reviewed in which agencies

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

and Grants Office told us that a governmentwide requirement for complete

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.

Common Criteria Used to

Select Certifying

Organizations

Transparency Is Not Free or

a Panacea
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Page 20 GAO/GGD-99-170 Certification Requirements

Federal agencies’ certification requirements are an invaluable tool in

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

Conclusions
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Page 21 GAO/GGD-99-170 Certification Requirements

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

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

and Human Services, Transportation, and Veterans Affairs and the Director

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

Recommendation

Agency Comments and

Our Evaluation
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Page 22 GAO/GGD-99-170 Certification Requirements

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

Contents

1 Letter

28

Department of Agriculture 28

Department of Commerce 29

Department of Health and Human Services 30

Department of Housing and Urban Development 32

Department of Labor 32

Department of Transportation 33

Department of Veterans Affairs 36

Environmental Protection Agency 36

Appendix I

Examples of Federal

Agencies' Certification

Requirements

Appendix II 38

GAO Contacts and

Staff

Acknowledgments
Contents

Page 25 GAO/GGD-99-170 Certification Requirements

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.
Contents

Page 26 GAO/GGD-99-170 Certification Requirements

USDA United States Department of Agriculture

VA Department of Veterans Affairs

WTO World Trade Organization
Page 27 GAO/GGD-99-170 Certification Requirements
Appendix I

Examples of Federal Agencies' Certification

Requirements

Page 28 GAO/GGD-99-170 Certification Requirements

This appendix briefly describes selected certification or certificationrelated 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

Service (AMS) provides voluntary on-site grading and certification of

meats and meat products through physical examination of product

characteristics during the production process. The required tests are

performed in government labs by AMS personnel, and approved USDA

stamps and roller brands are applied to products that are considered in

compliance with applicable standards or specifications. The grading

system provides a common language to facilitate trading, and the

certification assists large-scale buyers by providing impartial evaluation

and certification that meat purchases meet their contract specifications.

An AMS official also pointed out two related services provided under the

agency’s regulations. The Contract Verification Service provides

wholesale buyers of noncertified commodity products a method of

determining whether procurements meet contractually specified

requirements. The Quality Systems Certification Program provides meat

packers, processors, producers, or other businesses in the livestock and

meat trade the ability to have special processes or documented quality

management systems verified.

• USDA’s AMS also issues certificates regarding the quality of other

agricultural products, including fresh fruits, vegetables, nuts, and related

products. All of these certifications are voluntary, except for commodities

that are regulated for quality by a marketing order or marketing

agreement, or that are subject to import or export requirements. AMS also

issues grade certificates for raw cotton, which are mandatory for cotton

delivered on futures contracts.

• To assist in the export of plants and unprocessed plant products, USDA’s

Animal and Plant Health Inspection Service (APHIS) issues phytosanitary

(plant health) certificates to exporters certifying conformity with the

receiving country’s plant quarantine import regulations. The inspections

 1

 NIST SP–739, 4th Edition (Office of Standards Services, July 1999). NIST also publishes a separate

directory on laboratory accreditation programs, Directory of Federal Government Laboratory

Accreditation/Designation Programs (NIST SP–808).

Department of

Agriculture
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 29 GAO/GGD-99-170 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

Commerce’s National Oceanic and Atmospheric Administration (NOAA)

inspects seafood products and processing operations on a voluntary, feefor-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

Department of

Commerce
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 30 GAO/GGD-99-170 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

Control and Prevention (CDC), the agency included certification

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.

Department of Health

and Human Services
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 31 GAO/GGD-99-170 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.
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 32 GAO/GGD-99-170 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 moderateor 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

voluntary program for validation of private sector certifications of building

products for construction (i.e., that building products comply with

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

the Nationally Recognized Testing Laboratory (NRTL) Program. This

Department of Housing

and Urban

Development

Department of Labor
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 33 GAO/GGD-99-170 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 Transportation (DOT)-regulated transportation industries

(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

Department of

Transportation
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 34 GAO/GGD-99-170 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
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 35 GAO/GGD-99-170 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.
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 36 GAO/GGD-99-170 Certification Requirements

• The Department of Veterans Affairs (VA) requires certification of

automotive driving aids and automatic wheelchair lifts for purchases

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 governmentapproved 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

laboratory must conduct emissions testing for certification of new

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

Department of

Veterans Affairs

Environmental

Protection Agency
Appendix I

Examples of Federal Agencies' Certification Requirements

Page 37 GAO/GGD-99-170 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.
Appendix II

GAO Contacts and Staff Acknowledgments

Page 38 GAO/GGD-99-170 Certification Requirements

Curtis Copeland, (202) 512-8101

Tim Bober, (202) 512-4432

In addition to those named above, Alan Belkin, John Brosnan, and Victor

B. Goddard made key contributions to this report.

GAO Contacts

Acknowledgments
Page 39 GAO/GGD-99-170 Certification Requirements
Page 40 GAO/GGD-99-170 Certification Requirements
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