[Federal Register Volume 66, Number 52 (Friday, March 16, 2001)]
[Notices]
[Pages 15291-15295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6565]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
[Docket No. NRTL-1-01]
TUV Product Services GmbH, Application for Recognition
AGENCY: Occupational Safety and Health Administration (OSHA); Labor.
ACTION: Notice.
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SUMMARY: This notice announces the application of TUV Product Services
GmbH for recognition as a Nationally Recognized Testing Laboratory
(NRTL) under 29 CFR 1910.7, and presents the Agency's preliminary
finding. This preliminary finding does not constitute an interim or
temporary approval of this application.
DATES: Comments submitted by interested parties, or any request for
extension of the time to comment, must be received no later than April
16, 2001.
ADDRESSES: Submit written comments concerning this notice to: Docket
Office, Docket NRTL-1-01, U.S. Department of Labor, Occupational Safety
and Health Administration, Room N2625, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone: (202) 693-2350. Commenters may
transmit written comments of 10 pages or less in length by facsimile to
(202) 693-1648. Submit request for extensions concerning this notice
to: Office of Technical Programs and Coordination Activities, NRTL
Program, Occupational Safety and Health Administration, U.S. Department
of Labor, Room N3653, 200 Constitution Avenue, NW., Washington, DC
20210.
FOR FURTHER INFORMATION CONTACT: Bernard Pasquet, Office of Technical
Programs and Coordination Activities, NRTL Program, Room N3653 at the
above address, or phone (202) 693-2110.
SUPPLEMENTARY INFORMATION:
Notice of Application
The Occupational Safety and Health Administration (OSHA) hereby
gives notice that TUV Product Services GmbH (TUVPSG) has applied for
recognition as a Nationally Recognized Testing Laboratory (NRTL) for
testing and certification of the equipment or materials and using the
site, listed below. TUVPSG has also requested recognition to use
certain supplemental programs.
OSHA recognition of an NRTL signifies that the organization has met
the legal requirements in Sec. 1910.7 of Title 29, Code of Federal
Regulations (29 CFR part 1910.7). Recognition is an acknowledgment that
the organization can perform independent safety testing and
certification of the specific products covered within its scope of
recognition and is not a delegation or grant of government authority.
As a result of recognition, OSHA can accept products ``properly
certified'' by the NRTL. OSHA processes applications related to an
NRTL's recognition following requirements in Appendix A to 29 CFR
1910.7. This appendix requires that the Agency publish this public
notice of the preliminary finding on an application.
The current address of the laboratory covered by this application
is: TUV Product Services GmbH, Ridlerstrasse 65, D-80339, Munich,
Germany.
Background
According to the application, TUV Product Services GmbH (TUVPSG) is
a limited liability company founded under German law in 1988. TUVPSG
states that it is an ``international organization for testing,
evaluation, and certification of products and management systems.''
Also, the applicant states that it traces its origins to German steam
boiler inspection associations formed as early as 1866 ``to protect
workers against injury and to prevent damage to industrial
installations.'' TUVPSG owns and operates a number of laboratories in
Germany and in many other countries, including the U.S. However, the
recognition would only apply to the one location listed above.
The regulations for the NRTL Program in 29 CFR 1910.7 allow any
testing organization, whether or not it is US-based, to apply to OSHA
for recognition as an NRTL. However, in determining eligibility for a
foreign-based testing organization, such as TUVPSG, the regulations
require OSHA to take into consideration reciprocal treatment by the
foreign government of certain US-based testing agencies. Germany is
part of the European Union (EU), and the US and the EU have signed a
Mutual Recognition Agreement (MRA) on conformity assessment, which went
into effect in May 1999. The MRA includes provisions for the reciprocal
treatment of US-based testing agencies by governments of countries that
are part of the EU. As a result of the MRA, reciprocity is assumed for
all countries in the EU, and OSHA does not have to go through a
country-by-country determination. The MRA does not change any of the
requirements or processes that OSHA follows under its NRTL Program. For
more information on the MRA, refer to the U.S. Department of Commerce
web site.
In the application, TUVPSG states that it is owned by TUV
Suddeutschland and TUV Nord, both based in Germany. However, recently
TUV Suddeutschland (TUVS) became sole owner of TUVPSG.
Organizationally, the applicant falls within the ``Product Division''
of TUVS, one of its three main divisions. TUVS in general provides
testing and other technical services in a number of areas throughout
the world.
TUVPSG submitted an application for recognition, dated August 21,
1998 (see Exhibit 2-1). OSHA received this application from the
European Commission (EC) on March 1, 1999, along with applications from
other organizations located in the EU. The EC submitted the
applications under the provisions of the Electrical Safety Annex of the
MRA. However, none of these applications contained sufficient
information for processing, and OSHA returned them to the Commission in
April 1999 to obtain the additional information.
[[Page 15292]]
The Commission resubmitted the application for TUVPSG to OSHA,
which the Agency received on March 3, 2000 (see Exhibit 2-2). This
application includes the substantive portion originally submitted and
is therefore dated August 21, 1998. In the application, TUVPSG
requested recognition for four test standards, originally specifying
international test standards but, to meet OSHA requirements, later
specifying the equivalent US test standards. Some of the documents in
the application needed translation, which were received on June 5,
2000. In response to requests from OSHA for clarification and
additional information, TUVPSG supplemented its application in
submissions dated August 11 and August 28, 2000 (see Exhibits 2-3 and
2-4). It also supplemented its application in a submission dated
November 8, 2000 (see Exhibit 2-5), which included a request for
recognition of 34 additional test standards, bringing the total
standards requested for recognition to 38.
Some documents in the submissions, and parts of the original
application, have been designated as ``confidential'' by the applicant.
Generally, the applicant maintains the 4 levels of operational
documentation mentioned in international quality standards. It
generally considers its level 3 and 4 documents to be confidential or
privileged. OSHA has evaluated the applicant's designations and
believes the documents in question could be withheld from disclosure
under Exemption 4 of the Freedom of Information Act (FOIA). As a
result, OSHA has not included these documents in the public docket for
the application, which we further describe later in this notice.
Staff of the NRTL Program performed an on-site review (assessment)
of the Munich, Germany, facility on September 18-22, 2000. In the on-
site review report (see Exhibit 3), the program staff recommended a
``positive finding.''
Regarding the merits of the application, the applicant has
presented detailed documentation that describes how it currently
performs its testing and certification activities. The policies,
procedures, work instructions, methods, and other practices described
in this documentation would be used in its operations as an NRTL. Where
appropriate, it has supplemented or modified the policies and
procedures to conform to OSHA's requirements for an NRTL under 29 CFR
1910.7.
TUVPSG currently performs a large range of product testing and
certification activities, primarily testing to European based testing
standards, such as EN and IEC standards. For example, it currently
performs testing required under EN 60950, and has provisions for
addressing national deviations adopted by various countries, including
those for the US. One of the test standards for which it requests
recognition is UL 1950, which is equivalent to EN60950 but includes the
US deviations. TUVPSG performs its testing and certification activities
primarily to assure compliance of products to requirements under
directives issued within the European Union. However, it has also
performed testing to US based test standards, such as UL 1950. As part
of its current certification activities, it conducts initial and
follow-up inspections at manufacturers' facilities, one facet of the
activities that NRTLs recognized by OSHA must perform. It also
authorizes the use of certification marks, another aspect of the work
that NRTLs must perform. However, the marks it authorizes are primarily
necessary for the European marketplace. For purposes of its
certification under OSHA's NRTL Program, TUVPSG will utilize a US
registered certification owned by its subsidiary in the US.
The four recognition requirements of 29 CFR 1910.7 are presented
below, along with an explanation illustrating how TUVPSG has met or
plans to meet each of these requirements.
Capability
Section 1910.7(b)(1) states that for each specified item of
equipment or material to be listed, labeled or accepted, the laboratory
must have the capability (including proper testing equipment and
facilities, trained staff, written testing procedures, and calibration
and quality control programs) to perform appropriate testing.
The application and on-site review report indicates that TUVPSG has
adequate testing equipment and an adequate facility to perform the
tests required under the test standards for which it seeks recognition.
Security measures are in place to restrict or control access to their
facility, and procedures exist for handling test samples. The report
also indicates that testing and processing procedures are in place, and
the application describes the program for the development of new
testing procedures. The applicant submitted 24 specific test methods
that it currently uses and would utilize for its proposed NRTL testing
activities. For some of the test standards, it will develop testing
report formats prior to performing testing and certification of
products under the specific standard.
It utilizes outside calibration sources and also has procedures for
and performs internal calibrations of certain equipment. The
application indicates that TUVPSG maintains records on testing
equipment, which include information on repair, routine maintenance,
and calibrations. The application and on-site review report address
personnel qualifications and training, and identify the applicant's
staff involved with product testing, along with a summary of their
education and experience. Also, the report indicates that TUVPSG
personnel have adequate technical knowledge for the work they perform.
Moreover, the review report describes the applicant's quality assurance
program, which is explained in more detail in TUVPSG's Quality Manual.
Finally, the applicant performs internal system and internal technical
audits of its operations on a regular basis.
Control Procedures
Section 1910.7(b)(2) requires that the NRTL provide certain
controls and services, to the extent necessary, for the particular
equipment or material to be listed, labeled, or accepted. They include
control procedures for identifying the listed or labeled equipment or
materials, inspections of production runs at factories to assure
conformance with test standards, and field inspections to monitor and
assure the proper use of identifying marks or labels.
The applicant has procedures and related documentation for
initially qualifying a manufacturer and for performing the required
follow-up inspections at a manufacturer's facility. In its procedures,
it identifies criteria it will use to determine the frequency with
which it will perform these follow-up factory inspections. It has
adopted the criteria detailed in OSHA policies for NRTLs, which specify
that NRTLs perform no fewer than four (4) inspections per year at
certain facilities and no fewer than two (2) inspections per year under
certain conditions. The factory inspections would be one part of the
activities that the applicant will utilize in controlling its
certification mark. In its application, TUVPSG included evidence of the
application by its American subsidiary for registration of a TUV
certification mark with the U.S. Patent and Trademark Office (USPTO).
The applicant has procedures for control and issuance of product
certifications. According to the review report, it has issued in excess
of 25,000
[[Page 15293]]
certifications under its procedures that control product certification.
The applicant maintains a detailed database of the product
certifications, which would serve as its listing record. The report
also states that the applicant has experience in authorizing and
controlling the use of a certification mark, following many of the
procedures and methods it uses for control of its certification
certificates. For purposes of OSHA's NRTL Program, control by the NRTL
of its certification mark is uppermost in importance. TUVPSG's control
of a US registered certification mark under the NRTL Program will be a
new activity for the applicant, and OSHA proposes to include a
condition related to this control.
Independence
Section 1910.7(b)(3) requires that the NRTL be completely
independent of employers subject to the tested equipment requirements,
and of any manufacturers or vendors of equipment or materials being
tested for these purposes.
As previously stated, TUV Suddeutschland (TUVS) is currently the
sole owner of TUVPSG. In addition, application and other information
reviewed by OSHA has not revealed that TUVPSG has the kinds of
relationships described in OSHA policy that would cause the applicant
to fail to meet the independence requirement. Based on this
information, TUVPSG does not own or control and is not owned or
controlled by the kind of entities of concern to OSHA. In addition,
information on business activities and subsidiaries of the TUVPSG's
parent company has not revealed any apparent conflicts of interest that
could adversely influence the applicant's testing and certification
activities. TUVPSG has an employment contract that control conflicts of
interest.
Creditable Reports/Complaint Handling
Section 1910.7(b)(4) provides that an NRTL must maintain effective
procedures for producing credible findings and reports that are
objective and without bias, as well as for handling complaints and
disputes under a fair and reasonable system.
The applicant utilizes standardized formats for recording and
reporting testing data and inspection data. It has procedures for
evaluating and reporting the findings for testing and inspection
activities to check conformance to all requirements of a test standard.
The applicant included examples of completed inspection forms.
Regarding the handling of complaints and disputes, the applicant's
complaint management procedure provides the framework to handle
complaints it receives from its clients or from the public or other
interested parties. According to the review report, under one
certification system operated by the applicant, it must respond to an
initial complaint within 24 hours. OSHA has no such requirements for
NRTLs, but the review report indicates that the applicant will utilize
its current form of system controls and documentation to handle
complaints stemming from its NRTL certification activities.
Standards
TUVPSG seeks recognition for testing and certification of products
to determine compliance with the following 38 test standards, and OSHA
has determined the standards are ``appropriate,'' within the meaning of
29 CFR 1910.7(c). OSHA recognition of any NRTL for a particular test
standard is limited to equipment or materials (i.e., products) for
which OSHA standards require third party testing and certification
before use in the workplace. As a result, the Agency's recognition of
an NRTL for a test standard excludes any product(s), falling within the
scope of the test standard, for which OSHA has no such requirements.
UL 82 Electric Gardening Appliances
UL 122 Photographic Equipment
UL 507 Electric Fans
UL 508 Industrial Control Equipment
UL 561 Floor Finishing Machines
UL 745-1 Portable Electric Tools
UL 745-2-1 Particular Requirements of Drills
UL 745-2-2 Particular Requirements for Screwdrivers and Impact
Wrenches
UL 745-2-3 Particular Requirements for Grinders, Polishers, and Disk-
Type Sanders
UL 745-2-4 Particular Requirements for Sanders
UL 745-2-5 Particular Requirements for Circular Saws and Circular
Knives
UL 745-2-6 Particular Requirements for Hammers
UL 745-2-8 Particular Requirements for Shears and Nibblers
UL 745-2-9 Particular Requirements for Tappers
UL 745-2-11 Particular Requirements for Reciprocating Saws
UL 745-2-12 Particular Requirements for Concrete Vibrators
UL 745-2-14 Particular Requirements for Planers
UL 745-2-17 Particular Requirements for Routers and Trimmers
UL 745-2-30 Particular Requirements for Staplers
UL 745-2-31 Particular Requirements for Diamond Core Drills
UL 745-2-32 Particular Requirements for Magnetic Drill Presses
UL 745-2-33 Particular Requirements for Portable Bandsaws
UL 745-2-34 Particular Requirements for Strapping Tools
UL 745-2-35 Particular Requirements for Drain Cleaners
UL 745-2-36 Particular Requirements for Hand Motor Tools
UL 745-2-37 Particular Requirements for Plate Jointers
UL 775 Graphic Arts Equipment
UL 778 Motor-Operated Water Pumps
UL 987 Stationary and Fixed Electric Tools
UL 1017 Vacuum Cleaners, Blower Cleaners, and Household Floor
Finishing Machines
UL 1419 Professional Video and Audio Equipment
UL 1459 Telephone Equipment
UL 1585 Class 2 and Class 3 Transformers
UL 1776 High-Pressure Cleaning Machines
UL 1950 Technology Equipment Including Electrical Business Equipment
UL 3101-1 Electrical Equipment for Laboratory Use; Part 1: General
Requirements
UL 3111-1 Electrical Measuring and Test Equipment, Part 1: General
Requirements
UL 6500 Audio/Video and Musical Instrument Apparatus for Household,
Commercial, and Similar General Use
The designations and titles of the above test standards were
current at the time of the preparation of this notice.
Many of the Underwriters Laboratories (UL) test standards listed
above are approved as American National Standards by the American
National Standards Institute (ANSI). However, for convenience in
compiling the list, we show the designation of the standards developing
organization (e.g., UL 22) for the standard, as opposed to the ANSI
designation (e.g., ANSI/UL 22). Under our procedures, an NRTL
recognized for an ANSI approved test standard may use either the latest
proprietary version of the test standard or the latest ANSI version of
that standard, regardless of whether it is currently recognized for the
proprietary or ANSI version. Contact ANSI or the ANSI web site to find
out whether or not a standard is currently ANSI approved.
Programs and Procedures
TUV Product Services GmbH also seeks to use the supplemental
programs listed below, based upon the criteria detailed in the March 9,
1995 Federal Register notice (60 FR 12980, 3/9/95).
[[Page 15294]]
This notice lists nine (9) programs and procedures (collectively,
programs), eight of which (called supplemental programs) an NRTL may
use to control and audit, but not actually to generate, the data relied
upon for product certification. An NRTL's initial recognition always
includes the first or basic program, which requires that all product
testing and evaluation be performed in-house by the NRTL that will
certify the product. The on-site review report indicates that TUVPSG
appears to meet the criteria for use of the following supplemental
programs for which it has applied:
Program 2: Acceptance of testing data from independent
organizations, other than NRTLs.
Program 3: Acceptance of product evaluations from independent
organizations, other than NRTLs.
Program 4: Acceptance of witnessed testing data.
Program 8: Acceptance of product evaluations from organizations
that function as part of the International Electrotechnical Commission
Certification Body (IEC-CB) Scheme.
Program 9: Acceptance of services other than testing or evaluation
performed by subcontractors or agents.
OSHA developed the program descriptions to limit how an NRTL may
perform certain aspects of its work and to permit the activities
covered under the programs only when the NRTL meets certain criteria.
In this sense, they are special conditions that the Agency places on an
NRTL's recognition. OSHA does not consider these programs in
determining whether an NRTL meets the requirements for recognition
under 29 CFR 1910.7. However, OSHA does treat these programs as one of
the three elements that defines an NRTL's scope of recognition.
TUVPSG also sought recognition for the three remaining supplemental
programs, but OSHA is not granting recognition for these programs at
this time. Under these programs, an NRTL may use manufacturer's data in
performing the testing and evaluation activities required for a test
standard. However, as noted in the review report, the manufacturers for
which TUVPSG performs testing could lack sufficient familiarity with
testing to the US deviations. As stated in the report, TUVPSG may
reapply for the 3 programs ``in a few years when (the) manufacturers
have participated in the witness testing program'' and it is familiar
with their ``testing capability and confidence in their ability to test
to US deviations, with respect to products destined for the US
marketplace.''
Conditions
As already indicated, TUVPSG plans to utilize the proprietary US
registered mark of its US subsidiary in certifying products as an NRTL.
This is a new undertaking for the applicant and although it has
procedures for controlling a certification mark, it still needs to
further develop and refine the detailed procedures it will use to
control this particular mark. As a result, OSHA would conditionally
recognize TUVPSG subject to an assessment of the detailed procedures
and practices for controlling this mark once they are in place.
The US registered mark is the only one that OSHA would recognize
for TUVPSG. In addition, only the site listed in this notice will be
able to authorize use of this mark. Since this mark is specific to the
NRTL Program, the US subsidiary may not authorize its use unless it
were to be recognized as an NRTL. Similarly, none of the other TUVPSG
laboratories or locations may authorize the use of this mark. To ensure
the applicant and the public understand this fact, OSHA plans to impose
a condition to this effect.
As also noted, the applicant has just adopted procedures concerning
the criteria for determining the frequency at which it will conduct
factory follow-up inspections. Here too it needs more detailed
procedures to effectively and properly implement the criteria. OSHA
would have to review TUVPSG's approach in implementing the criteria for
the twice per year inspections before it begins to conduct inspections
at this frequency. As a result, OSHA would conditionally recognize
TUVPSG subject to an assessment of the details of this approach once it
is in place.
Imposing the proposed conditions is consistent with OSHA's past
recognition of certain organizations as NRTLs, which met the basic
requirements but needed to further develop or refine their procedures
(for example, see 63 FR 68306 12/10/1998; and 65 FR 26637, 05/08/2000).
Given the applicant's current breadth of activities in testing and
certification, OSHA is confident that TUVPSG would develop and
implement procedures and practices to appropriately perform the
activities in the areas noted above.
Therefore, OSHA would impose the following conditions in the final
notice to officially recognize TUVPSG as an NRTL. These conditions
apply solely to TUVPSG's operations as an NRTL and solely to those
products that it certifies for purposes of enabling employers to meet
OSHA product approval requirements. These conditions would be in
addition to all other conditions that OSHA normally imposes in its
recognition of an organization as an NRTL.
1. Within 30 days of certifying its first products under the NRTL
Program, TUVPSG will notify the OSHA NRTL Program Director so that OSHA
may review TUVPSG's implementation of its procedures for controlling
the US registered certification mark of its US subsidiary, TUV Product
Services, Inc., based in Danvers, Massachusetts.
2. Only TUV Product Services GmbH (TUVPSG) may authorize the US
registered certification mark currently owned by its US subsidiary, TUV
Product Services, Inc., based in Danvers, Massachusetts. TUVPSG may
authorize the use of this mark only at the facility recognized by OSHA.
3. Prior to conducting inspections of manufacturing facilities
based on a frequency of twice per year, OSHA must review and accept the
detailed procedures that TUVPSG will utilize to determine when to use
this frequency for such inspections.
Preliminary Finding
TUV Product Services GmbH (TUVPSG) has addressed the requirements
that must be met for recognition as an NRTL, as summarized above. In
addition, the NRTL Program staff has performed an on-site review of
TUVPSG's Munich, Germany, facility and investigated the processes,
procedures, practices, and general operations used by the laboratory.
Discrepancies noted by the review staff were addressed by TUVPSG
following the on-site review, as detailed above, and are included as an
integral part of the on-site review report (see Exhibit 3).
Following a review of the complete application file and the on-site
review report, the NRTL Program staff has concluded that the applicant
can be granted recognition as a Nationally Recognized Testing
Laboratory for the Munich, Germany, facility and for the 38 test
standards identified above, subject to the conditions described above.
The staff therefore recommended to the Assistant Secretary that the
application be preliminarily approved.
Based upon the recommendation of the staff, the Assistant Secretary
has made a preliminary finding that TUV Product Services GmbH can meet
the recognition requirements, as prescribed by 29 CFR 1910.7, for the
38 test standards and the facility noted above, with the conditions to
be applied as noted.
OSHA welcomes public comments, in sufficient detail, as to whether
TUV Product Services GmbH has met the
[[Page 15295]]
requirements of 29 CFR 1910.7 for its recognition as a Nationally
Recognized Testing Laboratory. Your comment should consist of pertinent
written documents and exhibits. To consider it, OSHA must receive the
comment at the address provided above (see ADDRESSES) no later than the
last date for comments (see DATES above). Should you need more time to
comment, OSHA must receive your written request for extension at the
address provided above (also see ADDRESSES) no later than the last date
for comments (also see DATES above). You must include your reason(s)
for any request for extension. OSHA will limit an extension to 30 days,
unless the requester justifies a longer period. We may deny a request
for extension if it is frivolous or otherwise unwarranted You may
obtain or review copies of TUVPSG's application, the additional
submissions, the on-site review report, and all submitted comments, as
received, by contacting the Docket Office, Room N2625, Occupational
Safety and Health Administration, U.S. Department of Labor, at the
above address. You should refer to Docket No. NRTL-1-01, the permanent
record of public information on TUVPSG's recognition application.
The NRTL Program staff will review all timely comments and, after
resolution of issues raised by these comments, will recommend whether
to grant TUVPSG's application for recognition. The Assistant Secretary
will make the final decision on granting the recognition, and in making
this decision, may undertake other proceedings that are prescribed in
Appendix A to 29 CFR 1910.7. OSHA will publish a public notice of this
final decision in the Federal Register.
Signed at Washington, DC, this 2d day of March, 2001.
R. Davis Layne,
Acting Assistant Secretary.
[FR Doc. 01-6565 Filed 3-15-01; 8:45 am]
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