[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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