[Federal Register Volume 59, Number 78 (Friday, April 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9125]


[[Page Unknown]]

[Federal Register: April 22, 1994]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 286

[Docket No. 920363-4058]
RIN: 0693-AB17

 

Establishment of the National Voluntary Conformity Assessment 
System Evaluation Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Final rule.

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SUMMARY: The National Institute of Standards and Technology (NIST) 
hereby establishes the National Voluntary Conformity Assessment System 
Evaluation (NVCASE) Program. The program will enable the Department of 
Commerce, acting through NIST, to evaluate and recognize competently 
conducted conformity assessment activities. The results of NIST 
evaluations will provide a basis for the U.S. Government to assure 
foreign governments that qualified conformity assessment bodies are 
competent to satisfy their regulatory requirements. The program 
supplements those of other Federal agencies and is intended, together 
with those programs, to provide a technical component of the basis for 
U.S. government negotiations and agreements with foreign governments to 
gain their recognition of U.S.-based conformity assessment bodies as 
providing results acceptable for their regulatory purposes.
    The program covers organizations engaged in product sample testing, 
product certification, and quality system registration, and most 
especially, their accreditors. NIST will offer its evaluations, based 
on publicly developed requirements, on a fee-for-service basis and will 
provide a certificate of recognition to those meeting the requirements. 
NIST will maintain lists of all recognized organizations and, in the 
case of recognized accreditation bodies, lists of conformity assessment 
bodies accredited by them within the scope of their recognition.
    The establishment of this program reflects the importance of 
conformity assessment activities to international trade. It is 
primarily intended to assist U.S. manufacturers in meeting foreign 
technical regulatory requirements on a cost-effective basis. The 
program is expected to enhance U.S. trade with other nations.

EFFECTIVE DATE: This rule is effective May 23, 1994.

FOR FURTHER INFORMATION CONTACT:
Mr. John L. Donaldson, Chief, Standards Code and Information, or Robert 
L. Gladhill, Program Manager, by mail at Admin. Bldg., room A629, NIST, 
Gaithersburg, MD 20899; by telefax at 301-963-2871; or, by telephone at 
301-975-4029.

SUPPLEMENTARY INFORMATION: As a consequence of discussions between 
former Commerce Secretary Mosbacher and European Community Commission 
Vice President Bangemann in June 1991, and in response to related 
private sector testimony at hearings of the Department of Commerce 
conducted by the International Trade Administration (ITA) in 1989 and 
the National Institute of Standards and Technology (NIST) in 1990, and 
taking account of comments received in response to prior Federal 
Register notices concerning this program, it has been concluded that 
NIST will respond to requirements by U.S. trading partners for 
governmental assurances that U.S.-based conformity assessment 
activities are competently performed in addressing the regulatory 
requirements of those foreign governments. This can be effectively 
accomplished by NIST evaluation of conformity assessment activities 
carried out in the U.S. and NIST attestation to the competency of their 
conduct.
    On July 23, 1993, NIST published in the Federal Register (58 FR 
39486) a proposal to establish the National Voluntary Conformity 
Assessment System Evaluation (NVCASE) Program, intended to evaluate the 
competency of requesting conformity assessment bodies in carrying out 
specified activities. Noted to be of particular importance were product 
sample testing, product certification, and quality system registration.
    During the public comment period, which closed October 6, 1993, 
NIST received 44 written responses to the request: 17 from trade 
associations and professional societies, nine from companies, eight 
from conformity assessment and accreditation bodies, two from Federal 
government agencies, two from other groups, plus six from individuals. 
The responses are available for review at the Department of Commerce 
Records and Inspection Facility, room 6020, Hoover Building, 
Washington, DC 20230.
    Of the 44 responses received, two individuals opposed the proposal, 
one association and one organization in the ``other'' category took no 
position, limiting their responses to comments only, and the remaining 
40 supported the proposal either fully or with some reservations, as 
represented by their comments.
    A total of 35 respondents offered comments for consideration with 
regard to modifying the proposal. Nine respondents--four trade 
associations, three individuals, and two companies--offered no comments 
beyond their unqualified support for or opposition to the proposal. The 
many comments received form the basis for the changes introduced in the 
final rule. Some changes in wording have been made simply for 
clarification, and some have been made to add or modify minor details. 
The comments that have resulted in substantive changes are summarized 
in the following discussion along with an indication of their content 
and location in the final rule.
    Five comments--from three trade associations, one conformity 
assessment body, and one ``other'' organization--requested that NIST 
relate the purpose of the program to acceptance of its results by 
foreign governments and clarify the relationship between NIST's program 
and negotiations with those governments. Specifically, one trade 
association expressed concern that ``there is no assurance that a 
`notified body' recognized by NIST would be recognized by the 
authorities having jurisdiction * * * .'' Another trade association 
observed that ``Any MRAs negotiated by the U.S. Government should 
ensure that our trading partners accept NVCASE program certificates of 
recognition.'' A third trade association echoed this view by requesting 
that NIST verify the type of assurance acceptable to our trading 
partners. One conformity assessment body recommended that NIST 
evaluation not exceed that required by the relevant foreign government. 
One ``other'' body commented that NIST should be prepared to adjust its 
program depending on the assurance needs of the foreign government. 
Section 286.1 has been modified to address these comments by stating 
that the qualifying bodies will be expected to meet the foreign 
government's requirements, the evaluation will be technically-based, 
and that the governments must agree on these matters. Mutual 
recognition and negotiations are not addressed in the rule, as the 
former may not be required and the latter is beyond the scope of NIST's 
technical program.
    Fourteen responses--from four associations, eight companies (of 
which six submitted the identical comment), one conformity assessment 
body, and one individual--requested that NIST reconsider its operation 
of the program at the accreditation level. Some of these comments 
observed that there was no requirement for NIST to offer accreditation 
of registration bodies, while the others requested more detail on the 
conditions and process for determining when an accreditation level 
activity would be necessary. Section 286.2(b) was changed to include 
reference to public consultation before any such decision is made. 
Similarly, eight responses--from six trade associations and two 
conformity assessment bodies--requested that NIST more clearly specify 
the conditions for NIST operation at the recognition level. Wording in 
Sec. 286.2(b) was also changed to stipulate the conditions under which 
NIST would undertake to recognize accreditors, using language suggested 
by several of the commenting trade associations.
    Seven comments--from four trade associations and three conformity 
assessment bodies--requested that NIST provide more details on public 
participation in formulating program specifics. Representative of these 
comments are those of a trade association that said that the rule 
should more clearly specify reliance on public workshops in developing 
criteria and procedures during implementation of the program; the trade 
association also cited the Federal Register as the preferred medium in 
which to announce proposals for comment. Reference to ``public 
consultation'' has been added to Sec. 286.2(b) (2) and (3); in 
Sec. 286.4, ``announcement'' and ``consultation'' have been cited 
explicitly as part of implementation; and in Sec. 286.6 reliance on 
public contributions has been further emphasized.
    Three comments--from two trade associations and one ``other'' 
organization--specifically addressed the need to allow for sectoral 
input into processes leading to decisions. Representative of these 
comments is the statement by one of the trade associations that NIST 
``should obtain public comment from the sector involved''. No change is 
made to the regulations based on these comments because NIST believes 
that the concerns are already adequately addressed in Sec. 286.6.
    Four comments--from two government agencies, one conformity 
assessment body, and one ``other'' organization--asked NIST to clarify 
the relationship between NIST's program and those of U.S. government 
regulatory agencies. In particular, the two government agencies 
requested that NIST make provision for consulting and conferring with 
the cognizant U.S. government agency with the relevant regulatory 
jurisdiction. The last sentence was added to Sec. 286.4 citing contact 
and coordination with Federal agencies; the second sentence in 
Sec. 286.6 was added to acknowledge a requirement to inform U.S. 
government agencies of ongoing NVCASE activities.
    Comments from three respondents--two conformity assessment bodies 
and one company--requested that NIST not cite only two international 
organizations as the sources for international guidelines on which to 
base program criteria and requirements. Section 286.5 was modified so 
that the reference is generic, with the two identified organizations 
cited only as examples.
    Three trade associations commented that NIST should reconsider 
quality system requirements on the basis that such requirements are 
premature at this time. The only explicit relevant statement, a 
requirement for quality system documentation in Sec. 286.7(a)(3), was 
deleted.
    Three comments--from one trade association, one conformity 
assessment body, and one ``other'' organization--asked NIST to assess 
fees on a fair and equitable basis to recover operating costs only. 
Wording was clarified accordingly in Sec. 286.7(a)(2), stating that the 
charged fee would cover the costs related to evaluation.
    Eight comments--from four trade associations, two conformity 
assessment bodies, one company, and one ``other'' organization--
expressed concern about how NIST would safeguard the confidentiality of 
information obtained in the course of its evaluations. Section 286.8 
has been modified to cite Department of Commerce procedures that will 
be followed and that address such concerns with regards to the Freedom 
of Information Act (FOIA), which is taken as the major cause for the 
concern expressed by those who commented. 15 CFR Part 4 details 
procedures followed by the Department in responding to FOIA requests; 
this part contains procedures for predisposition notification of 
submitters of confidential commercial information and opportunity to 
object to disclosure.
    Four comments--from two trade associations and two conformity 
assessment bodies--requested more detail in the rule on the appeals 
process. Section 286.10 has been expanded for this purpose; the change 
provides for an independent review that may be performed at the request 
of the Director.
    One comment from an ``other'' organization requested that NIST 
publicly identify only those conformity assessment bodies found to be 
competent, and to limit that identification to their capabilities 
within the scope of the evaluation. This comment was based on a concern 
that there be a clear demarkation between those conformity assessment 
bodies included within the scope of a recognized accreditor's scope of 
recognition and those not so encompassed. The wording in Sec. 286.11 
has been clarified to reflect this consideration in order to make it 
clear that NIST will make information readily available to the public 
on those bodies to which the recognition applies, by virtue of the 
recognition of their accreditor.
    A summary of comments received for which no textual changes have 
been made follows; some of the comments are beyond the scope of NIST's 
authority to address, while other comments would require an action that 
is not within the scope of the current stage in the development 
process. Three respondents--one professional society, one conformity 
assessment body, and one ``other'' organization--requested that NIST 
address the problem of reducing the liability of conformity assessment 
bodies on behalf of program participants; as a legal issue, its 
resolution is not amenable to actions within NIST's authority.
    Three respondents--one trade association, one conformity assessment 
body, and one ``other'' organization--asked that NIST extend the scope 
of the program to apply to domestic regulations, but this was addressed 
at the time of the original publication announcing the proposal to 
develop the program and is not subject to change at this stage of 
program development. Three respondents--two trade associations and one 
conformity assessment body--requested that the scope of an accreditor 
recognition be unlimited, not restricted to a specified technical 
regulatory subject. This request was deemed contrary to the originally 
proposed program and the basis upon which it has been justified. One 
comment--by a conformity assessment body--asked NIST to provide for 
recognition based on considerations other than a technical evaluation 
by NIST. This comment should be addressed, not by modifying the NIST 
program, but by having other program options made available as needed.
    Having completed its analysis and having made the responsive 
changes cited, NIST concludes that the rule as herein published to be 
in the final form and by this announcement establishes the NVCASE 
program.

Additional Information

Executive Order 12866

    This document was reviewed by the Office of Management and Budget 
under Executive Order 12866.

Executive Order 12612

    This rule does not contain policies with Federalism implications 
sufficient to warrant preparation of a Federalism Assessment under 
Executive Order 12612.

Executive Order 12372

    This rule does not involve Federal financial assistance, direct 
Federal development, or the payment of any matching funds from a state 
or local government. Accordingly, the requirements of Executive Order 
12372 are not applicable to this rule.

Regulatory Flexibility Act

    The General Counsel of the Department of Commerce has certified to 
the Chief Counsel for Advocacy of the Small Business Administration 
that this rule does not have a significant economic impact on a 
substantial number of small entities because program participation is 
on a voluntary basis. The program addresses the needs of business 
entities engaging in international trade and furthermore does not 
affect a substantial number of small business entities. Accordingly, a 
Regulatory Flexibility Analysis is not required to be prepared under 
the Regulatory Flexibility Act.

Paperwork Reduction Act

    The information collection requirements contained in this rule have 
been approved by the Office of Management and Budget under the 
Paperwork Reduction Act and have been assigned OMB Control No. 0693-
0019.

National Environmental Policy Act

    This rule will not significantly affect the quality of the human 
environment. Therefore, an environmental assessment or Environmental 
Impact Statement is not required to be prepared under the National 
Environment Policy Act of 1969.

List of Subjects in 15 CFR Part 286

    Accreditation, Conformity assessment, Laboratories, Product 
certification, Quality assurance, Quality registration, Standards, 
Testing.

    Dated: April 11, 1994.
Samuel Kramer,
Associate Director.

    For reasons set forth in the preamble, Title 15 of the Code of 
Federal Regulations is amended by adding subchapter J, part 286.

SUBCHAPTER J--ACCREDITATION AND ASSESSMENT PROGRAMS

PART 286--NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM 
EVALUATION (NVCASE) PROGRAM

Sec.
286.1  Purpose.
286.2  Scope.
286.3  Objective.
286.4  Implementation.
286.5  Program requirements.
286.6  Public consultation.
286.7  Evaluation process.
286.8  Confidentiality of information.
286.9  Maintaining recognized status.
286.10  Appeal.
286.11  Listings.
286.12  Terminations.

    Authority: 15 U.S.C. 272 et seq.


Sec. 286.1  Purpose.

    The purpose of this program is to enable U.S. industry to satisfy 
mandated foreign technical requirements using the results of U.S.-based 
conformity assessment programs that perform technical evaluations 
comparable in their rigor to practices in the receiving country. Under 
this program, the Department of Commerce, acting through the National 
Institute of Standards and Technology, evaluates U.S.-based conformity 
assessment bodies in order to be able to give assurances to a foreign 
government that qualifying bodies meet that government's requirements 
and can provide results that are acceptable to that government. The 
program is intended to provide a technically-based U.S. approval 
process for U.S. industry to gain foreign market access; the 
acceptability of conformity assessment results to the relevant foreign 
government will be a matter for agreement between the two governments.


Sec. 286.2  Scope.

    (a) For purposes of this program, conformity assessment consists of 
product sample testing, product certification, and quality system 
registration. Associated activities can be classified by level:
    (1) Conformity level: This level encompasses comparing a product, 
process, service, or system with a standard or specification. As 
appropriate, the evaluating body can be a testing laboratory, product 
certifier or certification body, or quality system registrar.
    (2) Accreditation level: This level encompasses the evaluation of a 
testing laboratory, a certification body, or a quality system registrar 
by an independent body--an accreditation body--based on requirements 
for the acceptance of these bodies, and the granting of accreditation 
to those which meet the established requirements.
    (3) Recognition level: This level encompasses the evaluation of an 
accreditation body based on requirements for its acceptance, and the 
recognition by the evaluating body of the accreditation body which 
satisfies the established requirements.
    (b) NIST operates the NVCASE program as follows:
    (1) Conformity level: Under this program NIST accepts requests for 
evaluations of U.S. bodies involved in activities related to conformity 
assessment. NIST does not perform conformity assessments as part of the 
program and therefore does not accept requests for such evaluations.
    (2) Accreditation level: NIST accepts requests for accreditation of 
conformity assessment bodies only when (i) directed by U.S. law; (ii) 
requested by another U.S. government agency; or (iii) requested to 
respond to a specific U.S. industrial or technical need, relative to a 
mandatory foreign technical requirement, if it has been determined 
after public consultation that (A) there is no satisfactory 
accreditation alternative available and the private sector has declined 
to make acceptable accreditation available, and (B) there is evidence 
that significant public disadvantage would result from the absence of 
any alternative.
    (3) Recognition level: NIST accepts requests for recognition of 
bodies that accredit testing laboratories, certification bodies, and 
quality system registrars when (i) directed by U.S. law; (ii) requested 
by another U.S. government agency; or (iii) requested to respond to a 
specific U.S. industrial or technical need relative to a mandatory 
foreign technical requirement if it has been determined after public 
consultation that (A) there is no suitable alternative available and 
(B) there is evidence that significant public disadvantage would result 
from the absence of any alternative.


Sec. 286.3  Objective.

    The objective of the program is to identify the activities of 
requesting U.S.-based conformity assessment bodies that have been 
evaluated as meeting requirements established for their acceptance by 
foreign governments. The evaluations may be provided by NIST or by 
bodies recognized by NIST for this purpose under the scope of this 
program.


Sec. 286.4  Implementation.

    The program is operated on a cost reimbursable basis. It is open 
for voluntary participation by any U.S.-based body that conducts 
activities related to conformity assessment falling within the 
program's scope. A common procedural approach is followed in responding 
to a request to participate. (See Sec. 286.7 Evaluation process.) All 
evaluation activities rely on the use of generic program requirements 
based on standards and guides for the operation and acceptance of 
activities related to conformity assessment. Specific criteria for use 
in each evaluation are derived from the program requirements, as 
appropriate, for the mandated foreign technical requirements specified 
in the request to participate. A request involving a foreign technical 
requirement not previously addressed by NVCASE will result in an 
announcement of NIST's intent to develop evaluation criteria specific 
to the relevant requirements. NIST will contact all cognizant and 
interested federal agencies to coordinate appropriate actions and 
procedures.


Sec. 286.5  Program requirements.

    NIST provides and maintains documented generic requirements to be 
applied in evaluations related to accreditation and recognition within 
the scope of the program. Available documentation is provided on 
request to prospective program participants and other interested 
parties. Generic requirements are developed with public input and are 
based on guides for the acceptance of conformity assessment activities 
issued by such international organizations as the International 
Organization for Standardization and the International Electrotechnical 
Commission. NIST also provides and maintains documented criteria 
provided in response to requests for evaluations specific to mandated 
foreign technical requirements. Criteria are developed with public 
input derived from the application and interpretation of generic 
program requirements in relation to specified mandated requirements. 
Both documented generic requirements and specific criteria are 
developed and maintained with input from the public.


Sec. 286.6  Public consultation.

    NIST relies on substantial advice and technical assistance from all 
parties interested in program requirements and related specific 
criteria. Interested U.S. government agencies are routinely to be 
informed of prospective NVCASE actions, and advice is sought from those 
agencies on any actions of mutual interest. In preparing program 
documentation, input is also sought from workshops announced in the 
Federal Register and open to the general public and other public means 
to identify appropriate standards and guides and to develop and 
maintain generic requirements, based on the identified standards and 
guides. Where relevant Federal advisory committees are available, their 
advice may also be sought. Similar procedures will be followed with 
respect to each request for evaluation which necessitates the 
development of criteria, derived from the generic requirements, 
specific to mandated foreign technical requirements.


Sec. 286.7  Evaluation process.

    (a) Each applicant requesting to be evaluated under NVCASE is 
expected to initiate the process and assume designated responsibilities 
as NIST proceeds with its evaluation:
    (1) Application. The applicant completes and submit a request to be 
evaluated.
    (2) Fee. The applicant submits a partial payment with the 
application and agrees to submit the remaining balance based on 
evaluation costs as a condition for satisfactory completion of the 
process.
    (3) Documentation. The applicant operates a system and procedures 
that meet the applicable generic requirements and specific criteria. 
Relevant documentation submitted with the application is reviewed by 
NIST.
    (4) On-site assessment. The applicant and NIST cooperate in the 
scheduling and conduct of all necessary on-site evaluations, including 
the resolution of any deficiencies cited.
    (5) Final review. The applicant provides any supplementary 
materials requested by NIST, then NIST completes the review and decides 
on appropriate action.
    (b) NIST may take one of the following actions with regard to an 
applicant:
    (1) Certificate. If an applicant fully demonstrates conformity with 
all program requirements and specific criteria, NIST issues a 
certificate documenting this finding. Each certificate is accompanied 
by a document describing the specific scope of the accreditation or 
recognition.
    (2) Denial. If an applicant cannot demonstrate conformity with all 
program requirements and specific criteria, NIST may deny award of the 
certificate. An applicant who has failed to complete the evaluation 
satisfactorily may reapply when prepared to demonstrate full 
conformance with program requirements.


Sec. 286.8  Confidentiality of information.

    All information collected relative to an applicant during an 
evaluation is maintained as confidential. Information is released only 
as required under the terms of the Freedom of Information Act or other 
legal requirement, subject to the rules of the Department of Commerce 
for such disclosure as found in 15 CFR part 4.


Sec. 286.9  Maintaining recognized status.

    Each program participant remaining in the program shall 
continuously meet all program requirements and cooperate with NIST in 
the conduct of all surveillance and reassessment activities. 
Participants shall reimburse NIST for expenses incurred for these 
purposes.


Sec. 286.10  Appeal.

    Any applicant or other affected party may appeal to the NIST 
Director any action taken under the program. When appropriate, the 
Director may seek an independent review by the Deputy Chief Counsel.


Sec. 286.11  Listings.

    (a) NIST maintains lists of all bodies holding current NIST program 
certificates, together with the assessment areas for which they are 
issued.
    (b) NIST also maintains lists of those qualified conformity 
assessment bodies that are currently accredited by bodies recognized by 
NIST, along with the activities of the assessment bodies within the 
scope of the NIST recognition program.
    (c) The lists are made available to the public through various 
media, e.g., printed directories, electronic bulletin boards, or other 
means to ensure accessibility by all potential users.
    (d) With respect to the lists specified in paragraph (a) and (b) of 
this section, NIST may delist any body if it determines the action to 
be in the public interest.


Sec. 286.12  Terminations.

    (a) Voluntary termination. Any participant may voluntarily 
terminate participation at any time by written notification to NIST.
    (b) Involuntary termination. If a participant does not continue to 
meet all program requirements, or if NIST determines it to be necessary 
in the public interest, NIST may withdraw that participant's 
certificate. A body that has had its status as a certificate holder 
terminated may reapply when prepared to demonstrate full conformance 
with program requirements.

[FR Doc. 94-9125 Filed 4-21-94; 8:45 am]
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