[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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