Federal Registers - Table of Contents|
| Publication Date:||07/20/2001|
| Publication Type:||Notice|
| Fed Register #:||66:38032-38037|
| Standard Number:||1910.7; 1910.7 App A|
| Title:||TUV Product Services GmbH, Recognition as an NRTL|
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
[Docket No. NRTL1-2001]
TUV Product Services GmbH, Recognition as an NRTL
AGENCY: Occupational Safety and Health Administration (OSHA); Labor.
SUMMARY: This notice announces the Agency's final decision on the application of TUV Product Services GmbH for recognition as a Nationally Recognized Testing Laboratory (NRTL) under 29 CFR 1910.7.
EFFECTIVE DATE: This recognition becomes effective on July 20, 2001, and will be valid until July 20, 2006, unless terminated or modified prior to that date, in accordance with 29 CFR 1910.7.
FOR FURTHER INFORMATION CONTACT: Bernard Pasquet, Office of Technical Programs and Coordination Activities, NRTL Program, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N3653, Washington, DC 20210, or phone (202) 693-2110.
Notice of Final Decision
The Occupational Safety and Health Administration (OSHA) hereby gives notice of its recognition of TUV Product Services GmbH (TUVPSG) as a Nationally Recognized Testing Laboratory (NRTL). The scope of this recognition includes testing and certification of the equipment or materials, and the site, listed below. The recognition also includes TUVPSG's use of the supplemental programs described below. OSHA will detail TUVPSG's scope of recognition in an informational web page for the NRTL, which we will establish at (http://www.osha.gov/dts/otpca/nrtl/index.html). We maintain such a web page for each NRTL.
OSHA recognition of an NRTL signifies that the organization has met the legal requirements in Section 1910.7 of Title 29, Code of Federal Regulations (29 CFR 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, employers may use products "properly certified" by the NRTL to meet OSHA standards that require testing and certification.
The Agency processes applications by an NRTL for initial recognition or for expansions or renewal of this recognition following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding and, in the second notice, the Agency provides its final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope.
TUVPSG applied for recognition as an NRTL, pursuant to 29 CFR 1910.7, and OSHA published the required notice in the Federal Register on March 16, 2001 (66 FR 15291) to announce the application. The notice included a preliminary finding that TUVPSG could meet the requirements for recognition detailed in 29 CFR 1910.7, and invited public comment on the application by April 16, 2001. OSHA received one comment in response to the notice (see Exhibit 4-1).
The commenter did not support or oppose the application but requested certain documentation that the applicant has designated as confidential and requested an extension of the time to comment in order to review this documentation. Due to the designation by the applicant, OSHA did not make these documents available for public review. The commenter said it sought to obtain these documents "to provide meaningful comment as to whether the NRTL meets the requirements of 29 CFR 1910.7." The commenter believes some of the documents withheld are "industry common procedures."
We follow provisions of 29 CFR Part 70 in determining whether we can or must disclose application information. This part generally deals with procedures to process a request for disclosure under the Freedom of Information Act (FOIA). Under Subpart B of this Part 70, information designated as confidential by a business submitter may be afforded protection under Exemption 4 of the FOIA. This exemption protects commercial or financial information, the disclosure of which would cause substantial competitive harm to the submitter. As part of our normal process for handling applications, OSHA requested that the applicant provide reasons for designating certain application documents as confidential, and specifically whether disclosure would cause it substantial competitive harm. In its original submission (see Exhibit 2-2), the applicant had marked virtually all of its documents "Confidential." The applicant provided the necessary justification (see Exhibit 2-3), and OSHA reviewed it and the applicable documents and determined that their disclosure could reasonably be expected to cause the applicant substantial competitive harm. Therefore, we did not make certain documents available for public review. These documents are detailed internal procedures that explain more specifically how the applicant will operate and could potentially give to prospective or current competitors knowledge that could cause the applicant substantial competitive harm. OSHA has previously withheld from disclosure similar such documents in response to FOIA requests received concerning documents submitted by other NRTLs.
Based on TUVPSG's justification, we also are unable to disclose the documents to the commenter. Since we cannot disclose this information and the commenter bases its request for extension to comment upon a review of this information, we denied the request for extension. The application information that we have made public, the on-site review report, both available in our docket office, and the information we provided in the preliminary notice, and repeat in this current notice, adequately demonstrate that the applicant meets the requirements for recognition, subject to the conditions included in that notice. OSHA has responded to the commenter to explain the denial of the extension and to address the remainder of its comment.
You may obtain or review copies of all public documents pertaining to the application by contacting the Docket Office, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue, NW, Room N2625, Washington, D.C. 20210. You should refer to Docket No. NRTL1-2001, the permanent record of public information on the TUVPSG recognition. Please note that in the preliminary notice we incorrectly referred to the docket number as NRTL-1-01.
The current address of the facility (site) that OSHA recognizes for TUVPSG is: TUV Product Services GmbH, Ridlerstrasse 65, D-80339, Munich, Germany.
Background on the Applicant and the Application
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 applies only 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 (http://www.doc.gov)
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.
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 translations, which were received on June 5, 2000 (see Exhibit 2-6). 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.
As explained above and in the preliminary notice, 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.
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."
The applicant has presented detailed documentation that describes how it currently performs its testing and certification activities. Many of 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 mark that is 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.
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 indicate 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.
TUVPSG 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.
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 are 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 currently performs product certifications, as previously mentioned, and has procedures for control and issuance of these certifications. According to the review report, it has issued in excess of 25,000 certifications under these procedures. 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 includes a condition related to this control.
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, the information reviewed by OSHA has not indicated that TUVPSG has the kinds of relationships described in OSHA policy that would cause the applicant to fail to meet the independence requirement. This information shows that TUVPSG does not own or control and is not owned or controlled by the kind of entities of concern to OSHA. In addition, OSHA's review of 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 policies to protect against conflicts of interest by its employees.
Credible 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 has 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.
Programs and Procedures
OSHA is granting the request by TUVPSG 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). 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 these programs to limit how an NRTL may perform certain aspects of its work and to permit the activities covered under a program 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, these programs help to define the scope of that 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 manufacturers' 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 witnessed testing program, and it is familiar with their "testing capability and confidence in their ability to test US deviations, with respect to products destined for the US marketplace."
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 conditionally recognizes TUVPSG subject to an assessment of the detailed procedures and practices for controlling this mark once they are in place.
TUVPSG may use only the US registered mark for its NRTL certification activities. At the time of preparation of this current notice, the U.S. Patent and Trademark Office (USPTO) had not yet issued the Notice of Allowance for the mark. This notice must be issued before OSHA will place the mark on its web page that shows the marks used by NRTLs (http://www.osha.gov/dts/otpca/nrtl/nrtlmrk.html). In addition, only the site listed in this notice may authorize use of this mark. Since this mark is specific to the NRTL Program, the US subsidiary may not authorize use of the mark unless it is 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 imposes a condition to this effect.
As also noted, the applicant has just adopted procedures concerning the criteria for determining its frequency for conducting 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 twice per year inspections before it begins to conduct inspections at this frequency. As a result, OSHA conditionally recognizes TUVPSG subject to an assessment of the details of this approach once it is in place.
Imposing the 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 will develop and implement procedures and practices to appropriately perform the activities in the areas noted above.
Therefore, OSHA includes appropriate conditions below that TUVPSG must meet for recognition as an NRTL. These conditions apply solely to the TUVPSG 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, listed first under Conditions below, apply in addition to the other conditions below that OSHA normally imposes in its recognition of an organization as an NRTL. The NRTL Program staff includes these type of additional conditions on OSHA's informational web page for the NRTL, which we will establish under our web site at http://www.osha.gov/dts/otpca/nrtl/index.html. When the staff determine that a particular condition has been satisfied, not only for TUVPSG but for any NRTL, they will remove the condition from the web page and notify the NRTL accordingly. OSHA is not required to publish a public notice to remove conditions it imposes as part of its NRTL recognition activities.
Final Decision and Order
The NRTL Program staff has examined the application, the additional submissions, the on-site review report, and other pertinent documents. Based upon this examination and the program staff recommendation, OSHA finds that TUV Product Services GmbH has met the requirements of 29 CFR 1910.7 for recognition as a Nationally Recognized Testing Laboratory. The recognition applies to the site listed above. In addition, it covers the test standards, listed below, and it is subject to the limitations and conditions, also listed below.
OSHA hereby limits the recognition of TUVPSG to testing and certification of products for demonstration of conformance to the test standards listed below (see Listing of Test Standards). OSHA has determined that each test standard meets the requirements for an appropriate test standard, within the meaning of 29 CFR 1910.7(c).
The Agency's recognition of TUVPSG, or any other NRTL, for a particular test standard is always limited to equipment or materials (products) for which OSHA standards require third party testing and certification before use in the workplace. Conversely, OSHA's recognition of an NRTL for a test standard excludes the testing of any product(s), falling within the scope of the test standard, for which OSHA has no such requirements.
Listing of Test Standards
UL 82 Electric Gardening Appliances
The designations and titles of the above test standards were current at the time of the preparation of the preliminary notice.
Many of the test standards listed above are also 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 1950) for the standard, as opposed to the ANSI designation (e.g., ANSI/ UL 1950). 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 (http://www.ansi.org) and click "NSSN" to find out whether or not a test standard is currently ANSI- approved.
TUV Product Services GmbH must also abide by the following conditions of the recognition, in addition to those already required by 29 CFR 1910.7:
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;
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;
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;
OSHA must be allowed access to TUVPSG's facility and records for purposes of ascertaining continuing compliance with the terms of its recognition and to investigate as OSHA deems necessary;
If TUVPSG has reason to doubt the efficacy of any test standard it is using under this program, it must promptly inform the test standard developing organization of this fact and provide that organization with appropriate relevant information upon which its concerns are based;
TUVPSG must not engage in or permit others to engage in any misrepresentation of the scope or conditions of its recognition. As part of this condition, TUVPSG agrees that it will allow no representation that it is either a recognized or an accredited Nationally Recognized Testing Laboratory (NRTL) without clearly indicating the specific equipment or material to which this recognition is tied, or that its recognition is limited to certain products;
TUVPSG must inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, and of any major changes in its operations as an NRTL, including details;
TUVPSG will meet all the terms of its recognition and will always comply with all OSHA policies pertaining to this recognition; and
TUVPSG will continue to meet the requirements for recognition in all areas where it has been recognized.
Signed at Washington, DC this 10th day of July, 2001.
R. Davis Layne,
[FR Doc. 01-18148 Filed 7-19-01; 8:45 am]
BILLING CODE 4510-26-P
Federal Registers - Table of Contents|