Establishment of the National Voluntary Conformity Assessment System Evaluation Program

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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