Nationally recognized testing laboratories, etc.: TUV Product Services GmbH,

[Federal Register: March 16, 2001 (Volume 66, Number 52)]

[Notices]

[Page 15291-15295]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16mr01-62]

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.

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.

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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

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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).

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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

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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. 01-6565Filed3-15-01; 8:45 am]

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