[Federal Register Volume 60, Number 20 (Tuesday, January 31, 1995)]
[Notices]
[Pages 5901-5903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2327]



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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
[Docket No. 941256-4356]


National Voluntary Conformity Assessment Systems Evaluation 
(NVCASE) Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Notice of request for public comments.

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SUMMARY: This is to advise the public that the National Institute of 
Standards and Technology (NIST) has received a request from the 
American National Standards Institute (ANSI) to have its Accreditation 
Program for Certification Programs and the ANSI/RAB American National 
Accreditation Program for Registrars of Quality Systems recognized 
under the NIST National Voluntary Conformity Assessment Systems 
Evaluation (NVCASE) Program for specified European Union (EU) 
Directives and Mexican regulations relating to securing Mexican 
Certification Mark (NOM) certificates.

DATES: Comments on this request must be received by March 2, 1995.

ADDRESSES: Comments should be submitted in writing to Mr. Robert L. 
Gladhill, Program Manager, NVCASE, National Institute of Standards and 
Technology, Building 417, Room 107, Gaithersburg, MD 20899 or by 
telefax at 301-963-2971.

FOR FURTHER INFORMATION CONTACT:
Either Mr. John L. Donaldson, Chief, Standards Code and Information, or 
Robert L. Gladhill, NVCASE Program Manager, in writing at NIST, 417/
107, Gaithersburg, MD 20899, by telephone at 301-975-4029 or by telefax 
at 301-963-2871.

SUPPLEMENTARY INFORMATION: NIST received a letter from ANSI, dated May 
10, 1994 requesting general recognition under the NVCASE program. Under 
the procedures at 15 CFR Part 286, NIST may grant recognition to 
organizations only for performing specific activities covered under a 
specific mandatory foreign regulatory requirement(s). The ANSI letter 
was acknowledged by NIST in a letter dated July 12, 1994. In that 
letter ANSI was requested to submit additional information identifying 
the pertinent regulatory requirements for which it desires to gain 
recognition as competent to satisfy conformity assessment requirements.
    NIST received a second letter from ANSI, dated October 21, 1994, 
which provided a list of general European Union Directives and a 
reference to Mexican NOMs. The two letters are reproduced below.
May 10, 1994
John Donaldson,
Chief, Standards Code and Information, National Institute of 
Standards & Technology, Building 101, Rm. A629, Gaithersburg, MD 
20899

Re: Reference Docket No. 920363-4058, Establishment of the National 
Voluntary Conformity Assessment System Evaluation Program
    Dear John: Congratulations on completing and publishing (59 FR 
19129, April 22, 1994) the Final Rule establishing the National 
[[Page 5902]] Voluntary Conformity Assessment System Evaluation 
(NVCASE) Program. ANSI believes NVCASE has potential to promote U.S. 
products' access to foreign markets when foreign governments insist 
on U.S. government assurance that U.S. conformity assessment 
organizations are competent to satisfy the foreign regulatory 
requirements. NIST recognition of ANSI's accreditation service for 
certification programs and the ANSI-RAB American National 
Accreditation Program for Registrars of Quality Systems could, for 
example, help in the situation where the European Commission 
requests a government assurance of the competence of conformity 
assessment organizations who desire to participate in government to 
government Mutual Recognition Agreements. The ANSI and ANSI-RAB 
national accreditation programs are based on the same technical 
criteria that generally appear in the European directives relating 
to competence of notified bodies appointed by Member States.
    ANSI, RAB and the private sector have invested heavily in 
establishing the ANSI and ANSI-RAB accreditation programs to respond 
to marketplace needs. The essence of both accreditation programs is 
an initial and on-going assessment of the competence of a conformity 
assessment activity to international criteria in order to promote 
U.S. national and global marketplace acceptance of the work of the 
accredited conformity assessment activities. Through bilateral, 
regional and international discussions with counterpart national 
accreditation practices and an internationally-based system for 
global acceptance of product certifications and quality system 
registrations. NVCASE recognition will nicely complement these on-
going private sector initiatives when a foreign government insists 
on U.S. government involvement in the process.
    There, please consider this as a formal request under Section 
286,7 for recognition of the ANSI Accreditation Program for 
Certification and the ANSI-RAB American National Accreditation 
Program for Registrars of Quality Systems. If NVCASE is not yet 
accepting applications for recognition, then please consider this a 
notice of intention to seek such recognition, and please send 
whatever forms are necessary as soon as they are available. Please 
let us know the fees to be submitted under Section 286.7(a)(2). 
Also, can you estimate the remaining balance to secure recognition?
    Please send as soon as possible the ``documented generic 
requirements to be applied in evaluations related to accreditation 
and recognition within the scope of the program,'' mentioned in 
Section 286.5. Sections 286.5 and 286.6 state that ``generic 
requirements are developed with public input, and ``input is also 
sought from workshops.'' To the extent that such generic 
requirements are still in development, ANSI and RAB offer whatever 
assistance you may find helpful in organizing workshops or other 
means to facilitate ``public input.''
    We were very pleased to see the discussion in the preamble 
relating to the purpose of NVCASE to limit NVCASE to only those 
procedures necessary to meet foreign governments' requirements 
(Section 286.1). NVCASE ``recognition'' procedures should not exceed 
that required by the foreign government. As a generalization, the 
criteria for competence of European notified bodies as contained in 
the European directives are the same criteria used in the ANSI and 
ANSI-RAB accreditation programs. There may be only small variations 
needed in our accreditation programs depending upon any unique 
competence criteria identified in a particular European directive. 
The European directives place the obligation on Member States to 
name only ``competent'' notified bodies. The Member States often 
(though this is not a requirement) depend upon their relevant 
national accreditation system for an independent assessment of that 
competence. We see NVCASE essentially creating a similar 
relationship between our accreditation programs and the U.S. 
government. Based on our interactions with European national 
accreditation organizations through the European Accreditation of 
Certification (EAC) and International Accreditation Forum (IAF) we 
have learned that the national accreditation organizations' 
relationships with their respective governments are best described 
as cooperative or collaborative. In some cases the accreditation 
body is an agency of government. In other cases it is a quasi non-
governmental organization whose recommendations result in a 
government accreditation. In some cases it is a private sector 
organization whose accreditations are unilaterally considered by 
government in appointments of notified bodies. In all cases of which 
we are aware, the accreditation program derives (or derived during 
its initial stages) significant public sector funding. Thus, we 
request that you give strong consideration in the NVCASE procedures 
applicable to recognizing such accreditation programs as ours to the 
cooperative and facilitate relationships that exist between the 
European national accreditation programs and their corresponding 
governments. Our European accreditation counterparts are not faced 
with a ``regulatory'' relationship with their governments, but 
instead one in which the governments just utilize (to a greater or 
lesser extent in any particular Member State) the results of the 
accreditation in their appointment of notified bodies.
    We in the United States could undermine our competitive position 
internationally rather than advance it if the NVCASE recognition 
procedures for our accreditation programs generated significant 
additional costs for our national accreditation programs that will 
have to be born by the accredited organizations and their U.S. 
industrial clients. Our accreditation peers in Europe have received 
government subsidies for the equivalent accreditation service. 
Significant extra costs for NVCASE recognition would just exacerbate 
this competitive issue for U.S. conformity assessment programs.
    ANSI and RAB intend to offer the ANSI and the ANSI-RAB 
accreditation programs as a generic mechanism that could be used as 
the competence demonstrating component in any particular government 
to government negotiation of Mutual Recognition Agreements. Thus, we 
were grateful to note that the NVCASE programs would only operate at 
the accreditation level if (among several conditions) there is no 
satisfactory accreditation alternative available and the private 
sector has declined to make acceptable accreditation available 
(Section 286.2(2)). Our programs are striving to fill this need for 
an acceptable private sector accreditation mechanism and we envision 
few, if any situations that could not be addressed by our programs. 
For NVCASE to offer an accreditation program competing with our 
private sector efforts would be inappropriate and inconsistent with 
the concepts in OMB Circular A76 relating to government use of 
commercially available services.
    ANSI and RAB look forward to a close and cooperative working 
relationship with NIST in pursuing our common objective of assisting 
U.S. suppliers in meeting foreign technical regulatory requirements 
on a cost effective basis.

        Sincerely,

George T. Willingmyre, P.E.,
Vice President, Washington Operations.

cc: S. Mazza
    ANSI Board Committee on Conformity Assessment
    G. Lofgren, RAB

October 21, 1994.
John Donaldson,
Chief, Standards Code and Information, National Institute of 
Standards & Technology, Building 101, Room A-629, Gaithersburg, MD 
20899

    Dear John: This is an addendum to our May 10 formal application 
for recognition of the ANSI Accreditation Program for Certification 
Programs and the ANSI-RAB American National Accreditation Program 
for Registrars of Quality Systems under the National Voluntary 
Conformity Assessment System Evaluation (NVCASE) program. Our 
original application is included for reference as Appendix A.
    You indicated in your July 12 letter (Appendix B) that we should 
identify the foreign regulations for which our accreditation 
programs seek recognition. Based upon interest from currently 
accredited quality system registrars and product certification 
programs and industry sectors with high priority for on-going 
government to government mutual recognition agreement negotiations, 
the list of European Directives and foreign regulations is provided 
at Appendix C. Please note that our accreditation programs are 
designed to mirror the national accreditation programs in Europe and 
Mexico which use generic criteria to establish the competence of 
quality system registration or product certification programs no 
matter what the industry sector. Thus we would expect that NVCASE 
recognition granted for one program area could be easily extended to 
other areas without major extra effort or cost.
    You also noted that International Guides relevant to competence 
of quality system registration and product certification 
accreditation programs are not yet final. Because of the importance 
of moving forward quickly in the interest of continued American 
competitiveness, ANSI recommends [[Page 5903]] utilization of the 
relevant DRAFT guides in the interim period before the ISO Guides 
are published.
    ANSI and the Registrar Accreditation Board look forward to 
taking the next steps in the NVCASE recognition process as soon as 
possible.

      Sincerely,

George T. Willingmyre, P.E.,
Vice President, Washington Operations.

cc: S. Mazza
    ANSI Board Committee on Conformity Assessment
    G. Lofgren

Appendix A--May 10, 1994 Letter.

Appendix B--NIST Reply--Acknowledgement.

Appendix C

    European Directives and Regulation of the government of Mexico 
for which the American National Accreditation Program for Registrars 
of Quality Systems seeks recognition under the National Voluntary 
Conformity Assessment System Evaluation (NVCASE) program
     Active Implantable Medical Devices
     Medical Devices
     Telecommunications Terminal Equipment
     Gas Appliances
     Simple Pressure Vessels
     Machinery
     Mexican Regulation relating to securing the NOM 
certificates published in the Official Journal of Mexico June 14, 
1994
    European Directives for which the ANSI Accreditation Program for 
Certification Programs seeks recognition under the National 
Voluntary Conformity Assessment System Evaluation (NVCASE) program.
     Recreational Craft
     Personal Protective Equipment
     Gas Appliances
     Lawnmower Noise
    Interested persons should submit comments in writing to the 
above address. Contingent upon comments received, NIST will schedule 
public workshops to define general and specific criteria for each of 
the programs requested. All comments received in response to this 
notice will become part of the public record and will be available 
for inspection and copying at the Commerce Department Records and 
Inspection facility, room 6020, Hoover Building, Washington, DC 
20230.

    Date: January 24, 1995.
Samuel Kramer,
Associate Director.
[FR Doc. 95-2327 Filed 1-30-95; 8:45 am]
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