[Federal Register Volume 65, Number 155 (Thursday, August 10, 2000)]
[Rules and Regulations]
[Pages 48894-48902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-20262]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 287

[Docket No. 981222315-0219-02]
RIN 0693-AB49


Guidance on Federal Conformity Assessment Activities

AGENCY: National Institute of Standards and Technology (NIST), 
Commerce.

ACTION: Final policy guidance.

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SUMMARY: This document contains final policy guidance on Federal agency 
use of conformity assessment activities. The provisions are solely 
intended to be used as guidance for agencies in their conformity 
assessment activities and do not preempt the agencies' authority and 
responsibility to make regulatory

[[Page 48895]]

procurement decisions authorized by statute or required to meet 
programmatic objectives and requirements.

DATES: This guidance becomes effective August 10, 2000.

FOR FURTHER INFORMATION CONTACT: Dr. Belinda Collins, Director, Office 
of Standards Services, National Institute of Standards and Technology, 
Building 820, MS 2100, Room 282, Gaithersburg, MD 20899. Phone: (301) 
975-4000.

SUPPLEMENTARY INFORMATION:

Background

    This guidance outlines Federal agencies' responsibility for 
evaluating the efficacy and efficiency of their conformity assessment 
activities. Each agency is responsible for coordinating its conformity 
assessment activities with those of other appropriate government 
agencies and with those of the private sector to make more productive 
use of the increasingly limited Federal resources available for the 
conduct of conformity assessment activities and to reduce unnecessary 
duplication.
    This guidance applies to all agencies, which set policy for, 
manage, operate, or use conformity assessment activities and results, 
both domestic and international, except for activities carried out 
pursuant to treaties. ``Agency'' means any Executive Branch Department, 
independent commission, board, bureau, office, agency, government-owned 
or controlled corporation, or other establishment of the Federal 
government. It also includes any regulatory commission or board, except 
for independent regulatory commissions subject to separate statutory 
requirements regarding policy setting, management, operation, and use 
of conformity assessment activities. It does not include the 
legislative or judicial branches of the Federal government.

History of the Guidance

    In February 1996, The National Technology Transfer and Advancement 
Act (NTAA) of 1995 was enacted by Congress. Section 12 of the Act 
directed NIST to coordinate conformity assessment activities of 
Federal, state and local entities with private sector technical 
standards activities and conformity assessment activities with the goal 
of eliminating any unnecessary duplication of conformity assessment 
activities. The Office of Management and Budget (OMB) Circular A-119, 
revised February 19, 1998 directed the Secretary of Commerce to issue 
guidance to the agencies to ensure effective coordination of Federal 
conformity assessment activities. The Director of the National 
Institute of Standards and Technology (NIST), United States Department 
of Commerce, published proposed guidance in the Federal Register on 
Federal conformity assessment activities on November 3, 1999 (64 FR 
59691 (1999)). Closing date for comments was January 18, 2000.

Summary of Public Comments Received by the Agency in Response to 
the November 3, 1999 Request for Public Comments, and the Agency's 
Response to the Comments

    NIST received comments from nine commentors, including: one 
national standards coordinating and conformity assessment accreditation 
body, one government agency, one international company, one laboratory 
accreditation body, one certification body, one consulting 
organization, and three trade associations in response to its request. 
In addition, in September 1999, the U.S. General Accounting Office 
(GAO) published a report, entitled ``GAO/GGD-99-170--Certification 
Requirements: New Guidance Should Encourage Transparency in Agency 
Decisionmaking,'' which contained a recommendation for including a 
section in the guidance on the issue of transparency in agency 
certification decisionmaking. The 51 comments as well as the GAO 
recommendation were considered in finalizing the guidance. The 
following summarizes the comments received and the agency's response to 
the comments.

General Comments

    One national standards coordinating and conformity assessment 
accreditation body commented that the guidance should task only NIST 
with substantive objectives and identify the approach and procedures 
for accomplishing them.
    Response: In OMB Circular A-119, OMB stated that ``(t)o ensure 
effective coordination, the Secretary of Commerce must issue guidance 
to the agencies.'' This guidance is a response to that mandate. The 
suggested approach would not be consistent with OMB's mandate.
    One laboratory accreditation body commented the proposed rule 
should be withdrawn and that the guidance be issued as an annex to OMB 
Circular A-119.
    Response: This document is intended to serve as guidance for 
Federal agencies in implementing their responsibilities under the 
NTTAA, and is not a rule. The guidance was issued at the direction of 
OMB, which chose not to include conformity assessment in OMB Circular 
A-119. This comment has been forwarded to OMB for consideration during 
the next revision of the Circular.
    One government agency commented that while the examples in the 
guidance were helpful in describing how the guidance may be 
implemented, they should remain examples in the final version of the 
guidance.
    Response: NIST agrees with this comment.
    One government agency commented that Federal regulatory programs 
that engage in conformity assessment must apply a high degree of 
scrutiny to ensure that requirements are met. Therefore, it may be very 
difficult to rely on the work of private sector organizations, which 
understandably perform their activities for other motives and perhaps 
to a lesser degree of scrutiny. The guidance should present the option 
that private sector organizations rely on the conformity assessment 
activities of a Federal agency. This option would also promote the 
objectives under the proposed Section 287.1.
    Response: Elimination of unnecessary duplication and complexity in 
conformity assessment activities can be accomplished by relying on 
private sector conformity assessment programs and activities. However, 
reduction in duplication and complexity can also be accomplished by 
Federal agency reliance on other governmental conformity assessment 
activities, by reliance on supplier's declaration of conformity, or by 
encouraging the private sector to rely on governmental activities. The 
NTTAA does not indicate a preference for any specific approach. The 
determination of which approach best meets agency objectives is the 
responsibility of the agency.

Comments on Section 287.1

    One national standards coordinating and conformity assessment 
accreditation body commented that Section 287.1 should provide more 
information on the evaluation procedures to be used to evaluate the 
efficacy and efficiency of Federal conformity assessment activities.
    Response: The variety of conformity assessment activities conducted 
by different Federal agencies precludes development of specific 
evaluation techniques that would apply to all agencies. Guidance on how 
to measure certain aspects of performance (regulatory burden, cost-
benefit issues, etc.,) is available from the Office of Management and 
Budget (OMB) and from other sources within the Federal government, but 
this guidance must usually be tailored to reflect the type of

[[Page 48896]]

activities a given agency undertakes. NIST believes that evaluations of 
only one aspect of program performance can be misleading. Evaluations 
of program performance/effectiveness should consider all programmatic 
aspects, including an agency's legislative mandates, program objectives 
and resource availability.
    One laboratory accreditation body commented that the second and 
third sentences of Section 287.1 should be replaced by: ``Each agency 
should seek ways in which it can use existing conformity assessment 
activities of the private sector instead of creating or maintaining 
their own activities.''
    Response: The purpose and scope, as currently written in Section 
287.1, best reflects the intent stated in the Act, which is to 
eliminate ``unnecessary duplication and complexity in the development 
and promulgation of conformity assessment requirements and measures.'' 
This can be accomplished in a number of ways. Using the results of 
private sector conformity assessment activities is only one method.
    One laboratory accreditation body commented that the last sentence 
of Section 287.1 should be revised to cite the role of the U.S. Trade 
Representative (USTR) in overseeing the implementation of the U.S. 
trade obligations including commitments under the World Trade 
Organization (WTO) Agreement on Technical Barriers to Trade (TBT).
    Response: The guidance is not intended to address U.S. obligations 
or the USTR's role in implementing the WTO Agreement or in other trade 
agreements. This guidance addresses only matters covered in the NTTAA. 
The Federal government's obligations under the World Trade Organization 
Agreement and other trade agreements are addressed elsewhere.
    One consulting organization commented that NIST should state its 
position on who is responsible for accreditation in the United States.
    Response: Accreditation activities can be conducted by either the 
public and/or the private sector. The appropriate sector to be assigned 
responsibility for accreditation should be determined on a case-by-case 
basis. The need for accreditation also needs to be determined on a 
case-by-case basis. There is no one-size-fits-all solution to this 
issue.
    One certification body commented that the Interagency Committee on 
Standards Policy (ICSP) should be opened to regular participation and 
attendance by private sector standards developers and organizations 
providing conformity assessment services to facilitate cooperation and 
confidence between the government and private sector conformity 
assessment organizations.
    Response: The ICSP has invited a number of standards developers and 
conformity assessment organizations to present information and 
viewpoints on topics of interest to the ICSP. However, the ICSP is an 
interagency committee. Membership is restricted to the Federal 
departments and agencies listed in its charter.
    One certification body commented that the promotion of 
accreditation and/or recognition organizations that have not 
demonstrated added value to the marketplace should be discouraged.
    Response: NIST agrees with this comment. Agencies are responsible 
for meeting programmatic objectives in a cost-effective manner. 
However, it is the responsibility of each agency to determine which 
approach best meets its needs.
    One certification body commented that no single mechanism can meet 
the needs of all suppliers or acceptance authorities around the globe. 
New mechanisms that facilitate trade, provide regulatory confidence and 
protect public safety should be considered as they are developed and 
proven effective to meet the needs of supplier and acceptance 
authorities.
    Response: NIST agrees with this comment. However, it remains the 
responsibility of each agency to determine which mechanisms are 
appropriate for application within its programs.
    One trade association commented that the following objectives 
should be included in the proposed guidance:
     Eliminate the cost to government of conducting 
(developing) its own conformity assessment activities and thereby 
decrease the cost of goods procured and the burden of complying with 
agency regulation;
     Provide incentives and opportunities (to whom) to 
establish conformity assessment programs that serve national needs;
     Encourage long term growth of U.S. enterprises and promote 
efficiency and economic competition through harmonization of conformity 
assessment activities; and
     Further the policy of reliance upon the private sector to 
supply the government need for goods and services.
    Response: While the statements listed above are a partial list of 
potential benefits from implementation of the guidance, the objective 
of the guidance was clearly and succinctly defined in the NTAAA--to 
eliminate ``unnecessary duplication and complexity in the development 
and promulgation of conformity assessment requirements and measures.''

Comments on Section 287.2

    One national standards coordinating and conformity assessment 
accreditation body commented that the definition of recognition is too 
narrow in section 287.2 and is inconsistent with the way it is used in 
the example in section 287.4.
    Response: While the definition for the term ``recognition'' in 
Section 287.2 is appropriate; the term has been changed in the example.
    One national standards coordinating and conformity assessment 
accreditation body and one trade association commented that the 
definitions in the International Organization for Standardization/
International Electrotechnical Commission (ISO/IEC) Guide 2 should be 
cited without modification.
    Response: The definitions in section 287.2 were based on ISO/IEC 
Guide 2, but the definitions have been modified to better address the 
nature of Federal government conformity assessment activities. 
Definitions were considered necessary because agencies do not use 
consistent terminology in their regulatory and procurement conformity 
assessment programs. This inconsistent use of terminology could create 
potential confusion for agencies reading the guidance. NIST decided to 
define only those terms which were considered to be necessary to 
understand the guidance.
    One laboratory accreditation body commented that the World Trade 
Organization (WTO) Agreement on Technical Barriers to Trade (TBT) 
definition of conformity assessment should be referenced and 
``mandatory administrative procedures'' should not be excluded from the 
definition.
    Response: ISO/IEC Guide definitions have been used in accordance 
with the NTTAA's requirements that preference be given to the use of 
voluntary consensus standards. There is also no evidence in the Act or 
legislative history that Congress intended to include mandatory 
administrative procedures.
    The Occupational Safety and Health Administration (OSHA) commented 
that some of the key definitions in the notice do not correctly depict 
the Occupational Safety and Health Administration's (OSHA's) National 
Recognized Testing Laboratory (NRTL) Program. OSHA recognizes a 
testing/certification body under the NRTL Program, not an accreditation 
body. In addition, the agency commented that OSHA's

[[Page 48897]]

recognition does not mean that an organization is ``competent'' in 
testing or in certification to the extent that ``competent'' means 
adept, proficient or a similar term. To obtain recognition, an 
organization must demonstrate that it meets the requirements in 29 CFR 
1910.7, but this regulation does not include requirements for 
proficiency or other criteria to judge ``competence.''
    Response: NIST agrees that agencies do not use standardized 
terminology in their conformity assessment activities. In defining key 
terms, NIST intended to let the reader know what is meant by that term 
within the context of the guidance. NIST recognizes that the same term 
may be used by different agencies to mean very different types of 
activities. A footnote will be added to the definition for 
``accreditation'' to accommodate OSHA's activities.
    OSHA also commented that the definition of conformity assessment 
describes requirements as being applicable to ``products, services, and 
systems,'' but not to ``organizations'' and requested that the word 
``organizations'' be added.
    Response: The word ``organizations'' has been added.
    One international company, one laboratory accreditation body, and 
one trade association commented that the guidance should identify 
supplier's declaration as an appropriate option for agencies to 
consider in their conformity assessment policies, taking into account 
the appropriate balance of risks and benefits of first party 
(supplier), second party, and third party conformity assessment for 
specific products and services. The same trade association recommended 
that NIST amend the definition in the proposed Section 287.2 as 
follows: In the definition of conformity assessment, add ``suppliers 
declaration of conformity'' after ``inspection'' and add a definition 
for ``supplier's declaration of conformity.''
    Response: The guidance now includes reference to first, second and 
third party conformity assessment activities and procedures. The 
definition of conformity assessment has been amended to include 
``supplier's declaration of conformity.'' A definition of ``supplier's 
declaration of conformity'' has also been included. However, the 
guidance does not intend to suggest that any one method or activity is 
preferable. It is the responsibility of each agency to select the 
conformity assessment activities and procedures, which will best meet 
its legislative mandates and programmatic objectives in the most cost-
effective and efficient manner.

Comments on Section 287.3

    One national standards coordinating and conformity assessment 
accreditation body commented that NIST should be charged in section 
287.3 with ensuring that other agencies are aware of their obligation 
to adopt policies needed to accomplish the purpose of this guidance.
    Response: While NIST is charged with coordinating conformity 
assessment activities, agencies remain responsible for their own 
conformity assessment activities, including the adoption of any 
policies that agencies feel are needed to operate in accordance with 
their statutory mandates. NIST is available and willing to assist 
agencies in carrying out this responsibility and to provide guidance as 
needed.
    One national standards coordinating and conformity assessment 
accreditation body and one trade association commented that some 
attention should be given in section 287.3 to NIST's obligations beyond 
the Federal level, especially to its obligations at the state level.
    Response: NIST partially agrees with this comment. The language in 
the Act is unclear as to what Congress intended NIST to do with regard 
to state conformity assessment activities. However, in the 
Congressional House Record of 2/27/96 for The National Technology 
Transfer and Advancement Act (NTTAA), Representative Morella stated 
that: ``Section 12 Standards Conformity. Restates existing authorities 
for the National Institute of Standards and Technology (NIST) 
activities in standards and conformity assessment. Requires NIST to 
coordinate among Federal agencies, survey existing state and Federal 
practices, and report back to Congress on recommendations for 
improvements in these activities.'' NIST is undertaking studies of 
existing state conformity assessment practices, subject to resource 
limitations. NIST also plans to undertake additional activities with 
the states as resources become available. Any activities undertaken by 
NIST will be conducted in a manner that respects state sovereignty 
issues. NIST has added the following statement to the guidance: ``To 
the extent that resources are available, NIST will develop information 
on existing state conformity assessment practices; and, upon request by 
a state government agency, will work with that agency to reduce 
duplication and complexity in state conformity assessment activities.''
    One laboratory accreditation body commented that a new clause 
should be added to section 287.3 so that NIST would also ``encourage 
government participation and use of private sector, conformity 
assessment activities to the maximum extent practical.''
    Response: NIST disagrees. NIST is obligated to assist other Federal 
agencies in reducing duplication and complexity in their conformity 
assessment activities. The use of private sector conformity assessment 
activities is only one of a number of methods that can be used by an 
agency to accomplish this goal. It remains the responsibility of the 
agency to determine which method is most appropriate for its specific 
applications.

Comments on Section 287.4

    One national standards coordinating and conformity assessment 
accreditation body commented that the example in section 287.4, which 
uses the term ``recognition,'' does not support the use of the 
qualifier ``mutual.''
    Response: The agency agrees with this comment. The qualifier 
``mutual'' has been removed and the term ``recognition'' has been 
replaced.
    One national standards coordinating and conformity assessment 
accreditation body and one laboratory accreditation body commented that 
a list of references, containing the documents of the organizations 
cited in section 287.4 should be inserted in this section or that NIST 
should provide a list of specific conformity assessment guides and 
standards, perhaps as a separate document.
    Response: NIST believes that a better solution is to address an 
agency's need for a list of applicable standards on a case-by-case 
basis. NIST's National Center for Standards and Certification 
Information (NCSCI) assists agencies to identify possible conformity 
assessment standards/guides, which may be of interest for a specific 
application. The organizations listed in the guidance are examples, and 
are not intended to represent a comprehensive list of organizations 
that develop standards and guidance in the conformity assessment area. 
A specific list could omit standards of potential interest to agencies 
in conformity assessment related areas or from other organizations not 
included as examples. In addition, such a list would rapidly become 
outdated as ISO guides and standards in the conformity assessment area 
are revised, reissued, or removed. Lastly, standards that appear on 
such a list might be presumed by some to have a ``special blessing'' by 
NIST, which could create misunderstanding. Agencies can contact NCSCI 
for a list of standards in their area of interest.

[[Page 48898]]

    One national standards coordinating and conformity assessment 
accreditation body commented that section 287.4 should be rewritten to 
address the policies and procedures that should be adopted by agencies 
through the mechanism of the Interagency Committee on Standards Policy 
(ICSP). The development of a policy on conformity assessment might be 
stipulated that would address the roles of supplier's declaration, 
third parties, and accreditors.
    Response: As noted in section 287.3(a), NIST will assist ``the ICSP 
in developing policies and guidance on conformity assessment issues.'' 
Agency Standards Executives serving on the ICSP are responsible for 
determining which policies and procedures the ICSP should develop, 
which might be useful for consideration within their agencies. However, 
the individual agency is responsible for the final selection and 
implementation of the policies and procedures needed by the agency to 
implement the goals of the NTTAA.
    One national standards coordinating and conformity assessment 
accreditation body commented that the ICSP Agency Standards Executives' 
suitability for serving as change agents with respect to the conformity 
assessment activities of the Federal government should be reconsidered.
    Response: The selection of the ICSP Agency Standards Executives is 
the responsibility of the Agency, as noted in section 287.4(n). The 
agency is responsible for selecting an individual who is capable of 
carrying out the guidance in OMB Circular A-119 as well as the guidance 
in this document. If needed, the Agency is free to assign additional 
personnel to assist the Agency Standards Executive in carrying out 
these responsibilities.
    One international company commented that the examples listed in 
section 287.4(g) are limited to laboratory issues and organizations 
that are close to the Federal process. It would be appropriate to list 
some other organizations such as the American National Standards 
Institute (ANSI) or the International Organization for 
Standardization's (ISO) Committee on Conformity Assessment (CASCO) to 
indicate the broader direction that is intended.
    Response: The examples cited have been included in the guidance.
    One international company commented that organizations, such as the 
American National Standards Institute (ANSI) or the International 
Organization for Standardization's (ISO) Committee on Conformity 
Assessment (CASCO) be listed in section 287.4(j) to indicate the 
broader direction that is intended.
    Response: Section 287.4(j) does not list examples. Participation in 
the development of any private sector conformity assessment standards 
(consistent with the mission and objectives of the agency) would be 
included in this section. ANSI does not develop standards, so it would 
not be included in this section. ISO is a private sector organization, 
which develops conformity assessment standards, so participation in ISO 
CASCO is included in this section.
    One laboratory accreditation body commented that in section 
287.4(c), agencies need to consider ways to use not only conformity 
assessment results of others (both domestic and foreign), but the 
conformity assessment activities themselves as a replacement for their 
own activities.
    Response: This comment addresses matters beyond the scope of this 
guidance. Regulatory and procurement obligations of Federal agencies 
have been authorized by Congress, and such activities/systems cannot be 
replaced by private sector activities/systems without congressional 
approval or legislative change.
    One laboratory accreditation body commented that the examples in 
sections 287.4(e) and (h) are weak as they only suggest an agency might 
supplement (not replace) its own activities with outside conformity 
assessment activities mainly administered by other government agencies.
    Response: In section 287.4(e), NIST will include the example of the 
Federal Communications Commission's FCC Telecommunications 
Certification Body (TCB) program, which allows designated private 
entities to issue telecommunications equipment approvals for specified 
regulatory requirements in essentially the same manner as the FCC. FCC 
has also replaced requirements for premarketing approval with 
supplier's declaration of conformity for certain types of equipment.
    One laboratory accreditation body commented that in section 
287.4(f), it is not clear why ``mutual recognition'' is necessary or 
desirable between agencies when one-way recognition may also be 
appropriate.
    Response: This section has been reworded.
    One laboratory accreditation body commented that section 287.4(g) 
should delete any reference to the National Environmental Laboratory 
Accreditation Conference (NELAC) because NELAC specifically prohibits 
private sector laboratory accreditation bodies from being part of NELAC 
by suggesting that accreditation is an inherent government function. 
This is contrary to the intent of the NTTAA, which encourages use of 
private sector conformity assessment activities.
    Response: The purpose of the NTTAA is to eliminate unnecessary 
duplication and complexity in conformity assessment activities. While 
this can be done by relying on private sector conformity assessment 
programs and activities, it can also be accomplished by relying on 
other governmental activities, by relying on a supplier's declaration 
of conformity, or by encouraging the private sector to rely on 
governmental activities. While agencies should consider alternative 
approaches in their rulemaking and procurement activities, the 
determination of which approach best meets agency objectives is the 
responsibility of the agency.
    One laboratory accreditation body and one trade association 
commented that sections 287.4(i) should cite the USTR's role in trade 
policy. The same trade association commented that sections 287.4(j) 
should also cite the USTR's role.
    Response: While NIST recognizes the important role that the USTR 
has in developing trade related policies, as well as the 
responsibilities placed on Federal agencies as a result of trade 
agreements, such as the WTO Agreement, these roles and responsibilities 
are defined in other legislation and related documents. This guidance 
addresses only matters covered in the NTTAA.
    One laboratory accreditation body commented that there is no need 
for separate government recognition systems if equivalent systems exist 
in the private sector that provide equivalent recognition. Government 
recognition systems would add cost without adding value and would 
create unnecessary duplication and complexity, the opposite intent of 
the NTTAA.
    Response: In trade agreements, the need for government recognition 
of conformity assessment bodies is determined not only by the U.S. 
Government, but also by the other countries signatory to such an 
agreement. Since some governments do not deem the use of private sector 
systems to be adequate proof of competence in the absence of 
governmental recognition, such recognition becomes a requirement under 
the terms of the specific agreement. For domestic regulatory and 
procurement issues, it is the responsibility of each Federal agency to

[[Page 48899]]

determine whether use of a private sector system can adequately address 
all of its programmatic objectives and any relevant legislative 
mandates in a cost-effective manner.
    One trade association commented that while the reference to the 
National Cooperation for Laboratory Accreditation (NACLA) and the 
National Environmental Laboratory Accreditation Conference (NELAC) in 
section 287.4(g) begins to address the issue of duplication of 
accreditations for testing programs, the proposed guidance should also 
provide direction related to other forms of conformity assessment, such 
as certification and registration.
    Response: The organizations listed in section 287.4(g) are intended 
to serve only as examples of activities in which agencies should 
consider participation. The activities of ANSI have been added to the 
list of examples to better illustrate the broad range of activities 
where Federal participation is encouraged.
    One trade association commented that the wording in section 
287.4(c) should strongly encourage the use of private sector conformity 
assessment programs in lieu of the development of government programs. 
The same trade association commented that Section 287.4(e) include a 
requirement that NIST provide a centralized coordinating function in 
the determination of acceptable private sector conformity assessment 
practices. To allocate the responsibility to each agency only continues 
the duplication of accreditation and approval processes. NIST should 
advocate the use of private sector accreditation bodies that comply 
with national and international criteria as the tool to be used for 
determination of acceptance. The same trade association also commented 
that in section 287.4(f), mutual recognition of private sector 
procedures should be recommended for all agencies.
    Response: The purpose of the NTTAA is to eliminate unnecessary 
duplication and complexity in conformity assessment activities. While 
this can be done by relying on private sector conformity assessment 
programs and activities, it can also be accomplished by relying on 
other governmental activities, by relying on a supplier's declaration 
of conformity, or by encouraging the private sector to rely on 
governmental activities. While agencies should consider alternative 
approaches in their rulemaking and procurement activities, the 
determination of which approach best meets agency objectives is the 
responsibility of the agency.
    One trade association commented that in section 287.4(j), agencies 
should be encouraged to participate in the development of private 
sector conformity assessment procedures and programs as well as the 
development of standards. RESPONSE: NIST partially agrees with this 
comment. The responsibility for participation in conformity assessment 
programs and activities, as distinct from standards development, is 
covered in section 287.4(g). The examples in this section will be 
expanded to include participation in ANSI's conformity assessment 
related activities to better illustrate the intention of this section.
    GAO Recommendation: GAO recommended that the guidance include a 
section that ``specifically addresses the transparency of agencies' 
certification decisionmaking.'' GAO recommended 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.''
    Response: A new item has been added to section 287.4 of the 
guidance to address this issue.

Comments on Section 287.5

    One national standards coordinating and conformity assessment 
accreditation body commented that section 287.5 places responsibility 
for both standards and conformity assessment with one representative 
from each agency and noted that a significant majority of persons with 
major responsibilities for standards have no responsibility or 
knowledge of conformity assessment.
    Response: NIST partially disagrees with this comment. The Office of 
Management and Budget (OMB) A-119 indicates that more than one 
Standards Executive was not contemplated by OMB. That is, the Circular 
speaks of ``a'' Standards Executive (14(c)) and ``the'' Standards 
Executive (14(d)), etc. NIST and OMB believe that having only one 
Standards Executive would facilitate better coordination and 
communication for both standards and their related conformity 
assessment activities. However, both also recognize that because 
responsibility for an agency's conformity assessment activities may cut 
across organizational boundaries, it may be necessary to assign 
additional agency personnel to carry out these new responsibilities. 
The agency must ensure that these responsibilities are coordinated and 
should carefully define each staff member's responsibilities to ensure 
that the duties defined under this guidance and under OMB Circular A-
119 are effectively carried out.
    One laboratory accreditation body commented that section 287.5 
should contain reporting requirements for the annual agency reports to 
NIST and OMB, including whether each agency gave consideration to the 
use of relevant private sector, conformity assessment activities and 
the reason for not using them--similar to agencies' reporting under OMB 
Circular A-119. NIST itself should be required to make similar reports 
justifying it own conformity assessment activities.
    Response: Mandatory agency reporting requirements regarding 
conformity assessment activities were not specified in the NTTAA. 
Conformity assessment reporting requirements for all agencies, 
including NIST, remain voluntary.
    One government agency commented that the guidance states that each 
agency ``should coordinate its * * * activities'' to make ``more 
productive use of * * * limited Federal resources * * *.'' However, the 
``responsibilities'' under the proposed Section 2987.5 and the actual 
coordination could demand resources that may more than offset any gains 
expected from the coordination.
    Response: The guidance does not recommend that agencies undertake 
activities where the costs involved are likely to exceed the benefits 
realized. While coordination is often beneficial and should always be 
considered, the agencies themselves are responsible for the final 
decision as to the appropriate level of coordination and commitment of 
resources to the agency's conformity assessment activities.
    One trade association commented that a new responsibility should be 
added to this section-- ``To use private sector conformity assessment 
program results in all agency assessment programs.''
    Response: The goal of the guidance, which is spelled out in the 
NTTAA, can be accomplished in a number of ways. It is the 
responsibility of each agency to determine which option or set of 
procedures is most appropriate for its application.

Purpose of This Guidance

    This guidance outlines Federal agencies' responsibility for 
evaluation the efficacy and efficiency of their conformity assessment 
activities. Each agency is responsible for coordinating its conformity 
assessment activities with those of other appropriate government 
agencies and with those of private sector to make more productive use 
of the increasingly limited Federal resources available for the conduct 
of conformity assessment activities and to reduce unnecessary 
duplication.

Applicability of This Guidance

    This guidance applies to all agencies, which set policy for, 
manage, operate, or

[[Page 48900]]

use conformity assessment activities and results, both domestic and 
international, except for activities carried out pursuant to treaties. 
``Agency'' means any Executive Branch Department, independent 
commission, board, bureau, office, agency, government-owned or 
controlled corporation, or other establishment of the Federal 
government. It also includes any regulatory commission or board, except 
for independent regulatory commissions subject to separate statutory 
requirements regarding policy setting, management, operation, and use 
of conformity assessment activities. It does not include the 
legislative or judicial branches of the Federal government.

Rulemaking Requirements

    Under 5 U.S.C. 553(b)(A), this guidance is not subject to the 
notice and comment requirements of the Administrative Procedure Act. 
Furthermore, pursuant to 5 U.S.C. 553(d)(2), this guidance is not 
subject to the delayed effective date requirement of the Act. The 
Director has chosen to publish this document for comment only to obtain 
input from persons who may be affected by the guidance.

PRA Clearance

    This policy statement does not contain a collection of information 
for purposes of the Paperwork Reduction Act.

Executive Order 12866

    It has been determined that this action is significant for purposes 
of Executive Order 12866.

Regulatory Flexibility Act

    This action is exempt from the analytical requirements of the 
Regulatory Flexibility Act because notice and comment are not required 
for this action by section 553 of the Administrative Procedure Act or 
any other law.

List of Subjects in 15 CFR Part 287

    Conformity assessment, Procurement, Reporting and recordkeeping 
requirements.

    Dated: August 4, 2000.
Karen H. Brown,
Deputy Director.

    For the reasons set forth in the preamble, Part 287 is added to 
subchapter J of chapter II in Title 15 of the Code of Federal 
Regulations (CFR) to read as follows:

PART 287--GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT

Sec.
287.1   Purpose and scope of this guidance.
287.2   Definitions.
287.3   Responsibilities of the National Institute of Standards and 
Technology.
287.4   Responsibilities of Federal agencies.
287.5   Responsibilities of an Agency Standards Executive.

    Authority: Sec. 12, Pub. L. 104-113, 110 Stat. 782 (15 U.S.C. 
272).


Sec. 287.1  Purpose and scope of this guidance.

    (a) This part provides guidance for each Federal agency to use in 
evaluating the efficacy and efficiency of its conformity assessment 
activities. Each agency should coordinate its conformity assessment 
activities with those of other appropriate government agencies and with 
those of the private sector to reduce unnecessary duplication. This 
guidance is intended to help Federal agencies improve the management 
and coordination of their own conformity assessment activities with 
respect to other government entities and the private sector. This will 
help ensure more productive use of the increasingly limited Federal 
resources available to conduct conformity assessment activities. This 
will also support the role of the U.S. Government in pursuing 
international trade and other related negotiations and agreements with 
foreign countries and U.S. industry in pursuing agreements with foreign 
national and international private sector organizations.
    (b) This guidance applies to all agencies, which set policy for, 
manage, operate, or use conformity assessment activities and results, 
both domestic and international, except for activities carried out 
pursuant to treaties.
    (c) This guidance does not preempt the agencies' authority and 
responsibility to make regulatory or procurement decisions authorized 
by statute or required to meet programmatic objectives and 
requirements. These decision-making activities include: determining the 
level of acceptable regulatory or procurement risk; setting the level 
of protection; balancing risk, cost and availability of technology 
(where statutes permit) in establishing regulatory and procurement 
objectives; and determining or implementing procurement or regulatory 
requirements necessary to meet programmatic or regulatory objectives. 
Each agency retains broad discretion in its selection and use of 
regulatory and procurement conformity assessment practices and may 
elect not to use or recognize alternative conformity assessment 
practices if the agency deems them to be inappropriate, inadequate, or 
inconsistent with statutory criteria or programmatic objectives and 
requirements. Nothing contained herein shall give any party any claim 
or cause of action against the Federal government or any agency 
thereof. Each agency remains responsible for representation of the 
agency's views on conformity assessment in matters under its 
jurisdiction. Each agency also remains the primary point of contact for 
information on the agency's regulatory and procurement conformity 
assessment actions.


Sec. 287.2  Definitions.\1\
---------------------------------------------------------------------------

    \1\ Definitions of accreditation, certification, conformity 
assessment, inspection, supplier's declaration of conformity, 
registration and testing are based on the International Organization 
for Standardization (ISO)/International Electrotechnical Commission 
(IEC), Guide 2 (1996). In certain industrial sectors, it is 
recognized that organizations other than ISO or IEC may issue 
definitions relevant to conformity assessment, such as the Codex 
Alimentarius Commission with respect to the food industry sector.
---------------------------------------------------------------------------

    Accreditation means a procedure used to provide formal notice that 
a body or person is competent to carry out specific tasks. These tasks 
include: sampling and testing; inspection; certification; and 
registration.\2\
---------------------------------------------------------------------------

    \2\ For some agencies, accreditation may mean that a body or 
person meets requirements defined in a specific section(s) of the 
CFR. The referenced section(s) may include only limited requirements 
for demonstration of technical competency.
---------------------------------------------------------------------------

    Agency means any Executive Branch Department, independent 
commission, board, bureau, office, agency, government-owned or 
controlled corporation, or other establishment of the Federal 
government. It also includes any regulatory commission or board, except 
for independent regulatory commission subject to separate statutory 
requirements regarding policy setting, management, operation, and use 
of conformity assessment activities. It does not include the 
legislative or judicial branches of the Federal government.
    Agency Standards Executive means an official designated by an 
agency as its representative on the Interagency Committee for Standards 
Policy (ICSP) and delegated the responsibility for agency 
implementation of OMB Circular A-119 and the guidance in this part.
    Certification means a procedure used to provide written assurance 
that a product, process, service, or person's qualifications conforms 
to specified requirements.
    Conformity assessment means any activity concerned with determining 
directly or indirectly that requirements are fulfilled. Requirements 
for products,

[[Page 48901]]

services, systems, and organizations are those defined by law or 
regulation or by an agency in a procurement action. Conformity 
assessment includes: sampling and testing; inspection; supplier's 
declaration of conformity; certification; and quality and environmental 
management system assessment and registration. It also includes 
accreditation and recognition. Conformity assessment does not include 
mandatory administrative procedures (such as registration notification) 
for granting permission for a good or service to be produced, marketed, 
or used for a stated purpose or under stated conditions. Conformity 
assessment activities may be conducted by the supplier (first party) or 
by the buyer (second party) either directly or by another party on the 
supplier's or buyer's behalf, or by a body not under the control or 
influence of either the buyer or the seller (third party).
    Inspection is defines ad the evaluation by observation and judgment 
accompanied as appropriate by measurement, testing or gauging of the 
conformity of a product, process or service to specified requirements.
    NIST means the National Institute of Standards and Technology, an 
agency within the United States Department of Commerce.
    Recognition means a procedure used to provide formal notice that an 
accreditation body is competent to carry out specific tasks. These 
tasks include: the accreditation of testing laboratories and 
inspection, certification, and registration bodies. A governmental 
recognition system is a set of one or more procedures used by a Federal 
agency to provide recognition.
    Registration means a procedure used to give written assurance that 
a system conforms to specified requirements. Such systems include those 
established for the management of product, process or service quality 
and environmental performance.
    Sampling means the selection of one or more specimens of a product, 
process, or service for the purpose of evaluating the conformity of the 
product, process or service to specified requirements.
    Supplier's declaration of conformity means a procedure by which a 
supplier gives written assurance that a product, process, service or 
organization conforms to specified requirements.
    Testing means the action of carrying out one or more technical 
operations (tests) that determine one or more characteristics or 
performance of a given product, material, equipment, organism, person's 
qualifications, physical phenomenon, process, or service according to a 
specified technical procedure (test method).


Sec. 287.3  Responsibilities of the National Institute of Standards and 
Technology.

    (a) Work with agencies through the Interagency Committee on 
Standards Policy (ICSP) to coordinate Federal, state and local 
conformity assessment activities with private sector conformity 
assessment activities. NIST chairs the ICSP; assists the ICSP in 
developing and publishing policies and guidance on conformity 
assessment related issues; collects and disseminates information on 
Federal, state and private sector conformity assessment activities; and 
increases public awareness of the importance of conformity assessment 
and nature and extent of national and international conformity 
assessment activities.
    (b) Encourage participation in the ICSP by all affected agencies 
and ensure that all agency views on conformity assessment are 
considered.
    (c) To the extent that resources are available, develop information 
on state conformity assessment practices; and, upon request by a state 
government agency, work with that state agency to reduce duplication 
and complexity in state conformity assessment activities.
    (d) Review within three years from August 10, 2000, the 
effectiveness of the final guidance and recommend modifications to the 
Secretary as needed.


Sec. 287.4  Responsibilities of Federal agencies.

    Each agency should:
    (a) Implement the policies contained in the guidance in this part.
    (b) Provide a rationale for its use of specified conformity 
assessment procedures and processes in rulemaking and procurement 
actions to the extent feasible. Further, when notice and comment 
rulemaking is otherwise required, each agency should provide the 
opportunity for public comment on the rationale for the agency's 
conformity assessment decision.
    (c) Use the results of other governmental agency and private sector 
organization conformity assessment activities to enhance the safety and 
efficacy of proposed new conformity assessment requirements and 
measures. An example of this would be to collect and review information 
on similar activities conducted by other Federal, state and 
international organizations and agencies and private sector 
organizations to determine if the results of these activities can be 
used to improve the effectiveness of a proposed Federal agency 
conformity assessment activity.
    (d) Use relevant guides or standards for conformity assessment 
practices published by domestic and international standardizing bodies 
as appropriate in meeting regulatory and procurement objectives. Guides 
and standards for sampling, testing, inspection, certification, quality 
and environmental management systems, management system registration 
and accreditation are issued by organizations which include, but are 
not limited to, the American National Standards Institute, the 
International Organization for Standardization (ISO), the International 
Electrotechnical Commission (IEC), the International Telecommunications 
Union (ITU) and the Organization for Economic Cooperation and 
Development (OECD), the World Health Organization (WHO), and the Codex 
Alimentarius Commission. Each agency retains responsibility for 
determining which, if any, of these documents are relevant to its 
needs.
    (e) Identify appropriate private sector conformity assessment 
practices and programs and consider the results of such practices and/
or programs as appropriate in existing regulatory and procurement 
actions. Responsibility for the determination of appropriateness rests 
with each agency. Examples: an agency could use the results of private 
sector or other governmental conformity assessment activities to 
schedule procurement type audits more effectively. This could allow 
agencies to reduce the number and extent of audits conducted at 
companies which are performing in accordance with contract 
specifications and which are under review by a third party or another 
agency and to concentrate agency audit efforts on companies which have 
shown problems in conforming to contract specifications. Another 
example is the Federal Communications Commission's (FCC) 
Telecommunication Certification Body (TCB) program, which allows 
designated private entities to issue telecommunications equipment 
approvals for specified regulatory requirements. In addition, under 
Part 15, FCC premarketing approval requirements for certain types of 
equipment have been replaced with suppliers declaration of conformity 
to the regulations, provided test results supporting the declaration 
are obtained from an accredited testing lab.
    (f) Consider using the results of other agencies' conformity 
assessment procedures. Example: An agency could use the results of 
another agency's inspection/audit of a supplier to eliminate or reduce 
the scope of its own inspection/audit of that supplier.

[[Page 48902]]

    (g) Participate in efforts designed to improve coordination among 
governmental and private sector conformity assessment activities. These 
efforts include, but are not limited to, the National Cooperation for 
Laboratory Accreditation (NACLA) organization, the National 
Environmental Laboratory Accreditation (NELAC), the International 
Organizations for Standardization's (ISO) Committee on Conformity 
Assessment (CASCO), conformity assessment related activities of the 
American National Standards Institute (ANSI), and ICSP working groups 
dealing with conformity assessment issues.
    (h) Work with other agencies to avoid unnecessary duplication and 
complexity in Federal conformity assessment activities. Examples: An 
agency can participate in another agency's conformity assessment 
activities by conducting joint procurement audits/inspections of 
suppliers that sell to both agencies. An agency can share conformity 
assessment information with other agencies. An agency can use 
conformity assessment information provided by other agencies to the 
extent appropriate to improve the effectiveness and efficiency in its 
own conformity assessment activities. Conformity assessment information 
may include: Conformity assessment procedures and results, technical 
data on the operation of conformity assessment programs, processing 
methods and requirements for applications, fees, facility site data, 
complaint review procedures, and confidentiality procedures.
    (i) Encourage domestic and international recognition of U.S. 
conformity assessment results by supporting the work of the U.S. 
Government in international trade and related negotiations with foreign 
countries and U.S. industry in pursuing agreements with foreign 
national and international private sector organizations and any 
resulting activities/requirements resulting from those negotiations/
agreements.
    (j) Participate in the development of private sector conformity 
assessment standards to ensure that Federal viewpoints are represented.
    (k) Work with other agencies to harmonize Federal requirements for 
quality and environmental management systems for use in procurement and 
regulation, including provisions which will allow the use of one 
quality or environmental management system per supplier facility in the 
Federal procurement process and the sharing and usage of audit results 
and related information as appropriate.
    (l) Work with other ICSP members, NIST, and the private sector to 
develop national infrastructures for coordinating and harmonizing U.S. 
conformity assessment needs, practices and requirements in support of 
the efforts of the U.S. Government and U.S. industry to increase 
international market access for U.S. products.
    (m) Work with other ICSP members, NIST, and the private sector as 
necessary and appropriate to establish criteria for the development and 
implementation of governmental recognition systems to meet government 
recognition requirements imposed by other nations and regional groups 
to support the efforts of the U.S. Government to facilitate 
international market access for U.S. products.
    (n) Assign an Agency Standard Executive responsibility for 
coordinating the agency-wide implementation of the guidance in this 
part.


Sec. 287.5  Responsibilities of an Agency Standards Executive.

    In addition to carrying out the duties described in OMB Circular A-
119 related to standards activities, an Agency Standards Executive 
should:
    (a) Promote the following goals:
    (1) Effective use of agency conformity assessment related resources 
and participation in conformity assessment related activities of agency 
interest.
    (2) Development and dissemination of agency technical and policy 
positions.
    (3) Development of agency positions on conformity assessment 
related issues that are in the public interest.
    (b) Ensure that agency participation in conformity assessment 
related activities is consistent with agency missions, authorities, 
priorities, and budget.
    (c) Cooperate with NIST in carrying out agency responsibilities 
under the guidance in this part.
    (d) Consult with NIST, as necessary, in the development and 
issuance of internal agency procedures and guidance implementing the 
policies in this part.
    (e) Establish an ongoing process for reviewing his/her agency's 
existing conformity assessment activities and identifying areas where 
efficiencies can be achieved through coordination with other agency and 
private sector conformity assessment activities.
    (f) Work with other parts of his/her agency to develop and 
implement improvements in agency conformity assessment related 
activities.
    (g) Report to NIST, on a voluntary basis, on agency conformity 
assessment activities for inclusion in the annual report to the Office 
of Management and Budget (OMB) on the agency's implementation of OMB 
Circular A-119.
[FR Doc. 00-20262 Filed 8-9-00; 8:45 am]
BILLING CODE 3510-13-M