Occupational Safety and Health Administration (OSHA), Labor.
Request for information.
The Occupational Safety and Health Administration (OSHA) requests comments on a specific proposal submitted to OSHA to permit the use of a Supplier's Declaration of Conformity (SDoC) as part of, or as an alternative to, the Nationally Recognized Testing Laboratories (NRTLs) product approval process.Start Printed Page 69356
You must submit information or comments by the following dates:
Hard copy: Your information or comments must be submitted (postmarked or sent) by February 13, 2006.
Electronic transmission or facsimile: Your comments must be sent by February 13, 2006.
You may submit information or comments to this Request for Information, identified by docket number NRTL03-SDOC, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
OSHA Web site: http://ecomments.osha.gov. Follow the instructions for submitting comments on OSHA's Web page.
Fax: If your written comments are 10 pages or fewer, you may fax them to the OSHA Docket Office at (202) 693-1648.
Regular mail, express delivery, hand delivery and courier service: Submit three copies to the OSHA Docket Office, Docket No. NRTL03-SDOC, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-2625, Washington, DC 20210; telephone (202) 693-2350. (OSHA's TTY number is (877) 889-5627). OSHA Docket Office hours of operation are 8:15 a.m. to 4:45 p.m., e.s.t.
Instructions: All comments received will be posted without change to http://dockets.osha.gov, including any personal information provided. OSHA cautions you about submitting personal information such as social security numbers and birth dates.
Docket: For access to the docket to read background documents or comments received, go to http://dockets.osha.gov. Contact the OSHA Docket Office for information about materials not available through the OSHA Web page and for assistance in using the Web page to locate docket submissions.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Kevin Ropp, Director, OSHA Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. Telephone: (202) 693-1999. General and Technical information: MaryAnn Garrahan, Office of Technical Programs and Coordination Activities, NRTL Program, Room N-3653 at the address shown immediately above. Telephone: (202) 693-2110.End Further Info End Preamble Start Supplemental Information
OSHA requests information and comments on a specific proposal submitted to OSHA to permit the use of a Supplier's Declaration of Conformity (SDoC) as part of, or as an alternative to, the Nationally Recognized Testing Laboratories (NRTLs) product approval process. To help the public better understand the issues presented in this Request for Information (RFI), OSHA is first providing information about its current requirements regarding NRTLs and product approval. This RFI then describes and asks specific questions about the SDoC proposal submitted to OSHA.
A. What Are NRTLs?
NRTLs are qualified private organizations that meet the requirements in 29 CFR 1910.7 to perform independent (i.e., third-party) safety testing and product certification, and thereby receive OSHA recognition. To be recognized by OSHA as an NRTL, an organization must: (1) Have the appropriate capability to test and evaluate products for workplace safety purposes; (2) be completely independent of the manufacturers, vendors, and users of the products for which OSHA requires certification; (3) have internal programs that ensure proper control of the testing and certification process; and (4) establish effective reporting and complaint handling procedures (29 CFR 1910.7(b)).
Many of OSHA's workplace standards require that certain types of equipment be approved (i.e., tested and certified) by an NRTL. (In this RFI, OSHA refers to these provisions as “NRTL approval requirements.”) Most of OSHA's standards that require NRTL approval of equipment (also called “products” herein) used in the workplace are found in the Agency's General Industry standards, 29 CFR Part 1910. For example, 29 CFR 1910.303(a) (read together with the definitions of “approved” and “acceptable” in 29 CFR 1910.399) generally requires electric equipment or products used in the workplace to be approved by NRTLs. The term most often used in the standards to require NRTL approval is the term “approved.” Other terms in the standards that require NRTL approval include “certified,” “listed,” and “listed and labeled.” A comprehensive listing of NRTL approval requirements and the categories of product that must be approved can be found on OSHA's Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
Similar provisions for third-party approval of products exist to varying degrees in other OSHA standards. For example, OSHA's Electrical standards for Construction (Subpart K of 29 CFR Part 1926) require that approval of electric equipment be provided by a “qualified testing laboratory” (QTL). OSHA's definitions for NRTLs and QTLs are essentially equivalent.
B. Why Did OSHA Develop the NRTL Program?
Prior to 1971, national consensus organizations and other code developers had provisions for independent testing and certification of products to meet the safety requirements of their voluntary standards. For example, the National Fire Protection Association (NFPA) has long required safety testing of electric equipment in various provisions of the National Electrical Code (NEC). The NEC is the dominant electrical safety code in use in the United States.
During OSHA's first 2 years, the Agency adopted many established Federal standards and national consensus standards as OSHA standards under section 6(a) of the Occupational Safety and Health Act (OSH Act), 29 U.S.C. 655(a). Many of these standards contained requirements for equipment to be “approved,” “listed,” or “labeled” by certain qualified organizations that could provide consistent determinations about the safety of equipment. By adopting these standards, OSHA continued the long history in the United States of equipment testing being performed by independent testing organizations. The Agency wanted to assure itself, through such testing, that products used in the workplace would be safe. However, the consensus standards adopted by OSHA through section 6(a) of the OSH Act primarily sanctioned product approvals of only two organizations: Underwriters Laboratories Inc. (UL) and Factory Mutual Research Corporations (FMRC).
In the early 1980s, a successful lawsuit was brought by another testing organization that required OSHA to conduct a rulemaking to establish a program under which it would recognize any qualified testing laboratories that could test and certify equipment to meet these approval requirements, not only UL and FMRC. In 1988, OSHA finalized 29 CFR 1910.7, which established the NRTL Program and set forth procedures for evaluating and recognizing testing laboratories as NRTLs. (53 FR 12102, April 12, 1988.) Approval by NRTLs provides OSHA assurance of the safety of certain types of products used in the workplace, and the NRTL Program assures that the approvals are done by qualified testing and certification organizations.Start Printed Page 69357
C. What Is the NRTL Recognition Process?
OSHA's NRTL recognition process involves a thorough analysis of an NRTL's policies and procedures to ensure that the NRTL meets all of the requirements of 29 CFR 1910.7. OSHA reviews detailed documentation submitted by an applicant for NRTL recognition, and performs a comprehensive on-site review of the applicant's testing and certification facilities. The staff also conduct annual on-site audits to ensure that the NRTLs adequately perform their testing and certification activities and maintain the quality of those operations. (See Chapters 2 through 6 of the NRTL Program Directive CPL 1-0.3.)
NRTLs may be based in the United States or in other countries. Currently, there are 18 NRTLs, of which 16 are established in the United States and 2 are foreign-based. The recognition process (described in 29 CFR 1910.7) is the same for all laboratories, regardless of where they are established or located.
The States and territories operating OSHA-approved State plans are expected to adopt standards that rely on Nationally Recognized Testing Laboratories accredited by Federal OSHA, i.e., where workplace equipment and materials require safety certification or testing, the testing laboratory must have received Federal OSHA recognition as an NRTL for that equipment or material. A State plan may establish its own program for accrediting testing laboratories but only for in-State applicability, and the State must accept accreditation of NRTLs recognized by Federal OSHA for testing equipment and materials where State safety requirements are the same as the Federal.
D. How Are Products Designated as NRTL Approved?
NRTLs generally test and certify (i.e., approve) a product for its manufacturer before it is sold or shipped. When it has approved a product, the NRTL issues a certification document and permits the manufacturer to place the NRTL's registered certification mark or symbol on all units of the product manufactured. This certification mark on a product indicates that a particular NRTL has tested and certified that specific product. If it is not feasible to apply the certification mark directly on an NRTL-approved product, the mark may appear on the smallest packaging of the product. The NRTL Web pages within the OSHA Web site show the certification marks generally used by each NRTL. (http://www.osha.gov/dts/otpca/nrtl/index.html).
As indicated above, the NRTL performs two key operations in its approval process. First, it must test the product; i.e., it tests a representative unit or prototype of the product it will certify to ensure that it has appropriate safety features. NRTLs conduct such tests under their product safety-testing program. Second, it must certify the product, not only by issuing a certificate and authorizing use of its mark, but more broadly by operating a product-certification program, which, for purposes of OSHA requirements, consists of a listing and labeling and follow-up inspection programs. The certification program is fundamentally important to the approval process because through it the NRTL gains assurance that all manufactured units of the product have the same safety features as the unit initially tested and certified. For this purpose, the NRTL conducts regular inspections at the product manufacturer's factories or assembling facilities. These inspections involve NRTL review of specific operational areas, including testing that has been performed, quality and production controls, and control of the use of the NRTL's mark. The NRTL can also perform limited testing of samples of the product during the inspection or full retesting after the inspection.
E. Can Any NRTL Test and Certify Any Type of Product That OSHA Standards Require to Be “Approved?”
An NRTL applicant provides OSHA with a list of “appropriate test standards” that the applicant wishes to use for purposes of testing products. To be considered “appropriate,” the test standard must be a recognized safety standard in the U.S., compatible with and maintained current with national codes and standards, and developed by a standards developing organization (SDO) under a consensus-based process. (See 29 CFR 1910.7(c).) Each test standard covers particular types of products. If the applicant is recognized, OSHA then limits the NRTL's “scope of recognition” to those test standards, and thus certain products, for which the NRTL demonstrates to OSHA that it has the requisite technical capability. International test standards used in European and other countries may be applied if they have been harmonized to U.S. requirements by a U.S. SDO.
NRTLs have been recognized in the aggregate for more than 600 individual product safety standards, which cover thousands of individual types of products and, in actual usage, cover literally billions of certified products. A list of these standards is available on the NRTL pages of OSHA's Web site, which also provides an informational Web page for each NRTL that details its scope of recognition.
The NRTL's scope of recognition also includes specific “recognized sites,” which are the facilities that can perform the full range of testing and certification activities, and “programs,” under which the NRTL can use other parties in performing activities necessary for product testing and certification. Depending on the activity in question, these other parties may include other NRTLs, other non-NRTL independent testing labs, and product manufacturers, as appropriate.
F. What Are the Benefits and Significance of Using These Programs?
Allowing NRTLs to use testing done by other parties often reduces the time and cost necessary for product approval. While using these other testing resources can minimize the work of the NRTL, the NRTL is still required to exercise adequate control to ensure that other parties are performing their testing activities appropriately. OSHA allowed the use of testing done by other parties through an interpretation of its requirements, which was published in the March 9, 1995, Federal Register notice (60 FR 12980). OSHA commonly refers to these programs as the “March 9 programs.”
In permitting NRTLs to use these programs, OSHA allowed practices that were already being utilized by NRTLs, but defined the necessary minimum elements for their use. By doing this, OSHA improved the effectiveness and uniform application of these practices by all NRTLs and assured that all NRTLs would properly utilize the resources provided by other parties in testing and certifying products. Permitting these programs furthers OSHA's performance-based regulations for the NRTL Program, i.e., providing general criteria that must be met, but allowing particular NRTLs latitude in determining how they will meet them.
One program allows NRTLs to use product testing data that have been developed by other testing organizations under an international scheme for the exchange of test data, the “International Electrotechnical Commission—Certification Body (IEC-CB) Scheme.” This scheme facilitates the export and import of products by allowing NRTLs to utilize test data developed by testing organizations in foreign countries and similarly allowing those organizations to use data developed by NRTLs.
Today, the NRTL Program continues to evolve in response to other practices Start Printed Page 69358that NRTLs want to use or are using to address challenges they face or that are faced by manufacturers for which NRTLs certify products. Those manufacturers must often compete globally, and NRTLs have responded by expanding their overseas operations. As OSHA did in formalizing and accepting the March 9 programs, OSHA continues to investigate ways to be flexible to meet the business needs of the NRTLs. In fact, OSHA is considering the addition of a new program that would permit a qualified NRTL, which meets certain criteria, to perform approval activities at many more locations than OSHA currently allows. This program could potentially expedite any NRTL's approval activities, thus serving its needs and the needs of manufacturers of the products being approved. While the NRTL Program must evolve in the face of new challenges, we do so with the clear objectives of maintaining the effectiveness of our monitoring of the NRTLs and assuring that the safety of NRTL approved products is not compromised.
G. Is Approval by an NRTL Always Required for Equipment That Must Be “Approved”?
In general, products that are required to be “approved” in OSHA's standards must be NRTL-approved. However, there are exceptions. For example, under OSHA's electrical standards for general industry and construction, if electric equipment is of a kind that none of the NRTLs approve, then OSHA allows approval by a Federal agency or by a State or local code authority that enforces National Electrical Code workplace safety provisions. Similarly, NRTL approval is not required for “custom-made equipment,” which is equipment designed, made for, and used by a particular customer (i.e., unique or one-of-a-kind items). In this case, the employer must demonstrate safety based on test data provided by the manufacturer. (See definition of “acceptable”, 29 CFR 1910.399.)
As indicated above, NRTLs are “third-party” testing and certification organizations. Under the current NRTL program, a manufacturer of any equipment that must be NRTL-approved is not permitted to approve products, even if it has a testing laboratory that would otherwise qualify for NRTL status. The NRTL provisions in 29 CFR 1910.7 require that the testing laboratory be independent of any manufacturers of products being tested. The provision for independence is the cornerstone of the NRTL Program. OSHA relies upon this element of independence to assure that products have been properly tested and certified without the need for the Agency to engage in an extensive inspection and audit of manufacturers. Under the NRTL Program, the NRTLs perform this auditing function.
II. Proposal To Provide Alternative Approval Through “Supplier's Declaration of Conformity”
OSHA has received a proposal (Exhibit 1) from the Information Technology Industry Council (ITIC) to allow an employer to accept a “Supplier's Declaration of Conformity” (SDoC) as an alternative means of approval for information technology (IT) equipment or products, i.e., in lieu of NRTL approval of these products. An SDoC is a written statement—produced by an equipment manufacturer or supplier—that a product meets or conforms to a specified test standard or a set of requirements. OSHA has long been aware of the concept of manufacturer's self-approval and has known that it is allowed, for certain types of products, by a few other countries.
The proposal does not define the term “IT equipment” but instead gives three examples: computers, computer peripherals, and telecommunications equipment. (Exhibit 1, page 1.) However, the term could encompass many other types of equipment, especially if OSHA were to use, as a guide, all equipment covered under the relevant U.S. “IT equipment” test standard (identified below). For example, this test standard includes the following as examples of IT products: copying machines, facsimile machines, modems, personal computers, telephone sets, answering machines, and visual display units. Virtually all of these IT products are electric equipment under OSHA standards, and thus generally must be “approved” in order to be used in the workplace. (See definition of “equipment,” 29 CFR 1910.399.) Under the ITIC proposal, OSHA would allow an employer to use IT products that are “self-approved” by a manufacturer through SDoC rather than approved by one of the NRTLs. In its proposal, ITIC suggests that OSHA could classify the approval of a product through SDoC as a “de minimis” violation of the NRTL approval requirements. (Exhibit 1, page 3.)
A principal concern raised by ITIC on behalf of its members and other manufacturers, which it seeks to address through the SDoC, is the delay in bringing products to market (“time-to-market”), particularly in different countries, because of country-specific testing requirements and approval procedures. (Exhibit 1, page 2.) ITIC also alleges that IT equipment and IT manufacturers have a good workplace safety record, and that this record supports the use of SDoCs in lieu of NRTL testing.
ITIC further suggests that all IT equipment should be approved to meet the technical requirements of a test standard issued by the International Electrotechnical Commission (IEC): IEC 60950. (Exhibit 1A.) The IEC is a leading organization in the development of international test standards, and IEC 60950 represents IEC's test standard for IT equipment. ITIC advocates the use of this test standard by all countries. As discussed earlier, under OSHA's requirements, electric products must be tested by NRTLs to meet the requirements of appropriate U.S. test standards. In that regard, for IT products, OSHA notes that for OSHA and NRTL purposes, the IEC 60950 standard has already been harmonized to a corresponding U.S. test standard, UL 60950. Many NRTLs already use UL 60950 for approving IT equipment.
Finally, the proposal includes a study by Industry Canada, an agency of the Canadian government. (Exhibit 1B.) The study discusses ways that agencies in various countries use SDoCs for approvals of equipment. The study notes the importance, in an SDoC system, of having a responsible regulatory authority for audit and enforcement, focusing on their ability to identify “bad actors” after products are sold. (Exhibit 1B, page 2.) In contrast, under current OSHA regulations, NRTLs must perform key functions “before” sale. As noted earlier, an NRTL approving a product needs to ensure, generally before a manufacturer sells or ships a product, that (1) a representative unit of the product meets the provisions of applicable test standards (i.e., the NRTL tests and approves the product), and (2) the manufacturer or supplier of that product is complying with the terms of the approval. An NRTL also performs some “after sale” functions (e.g., by occasionally testing products Start Printed Page 69359taken off the store shelf, by responding to complaints from product users, and by “recalling” products that they find through such testing or complaints to pose safety concerns).
OSHA has reviewed information and documents pertaining to SDoC and met with ITIC and a few interested parties who provided some input on SDoC and their view of its advantages and disadvantages. Documents we have gathered to date, including the ITIC proposal, are available at the OSHA Docket Office. In general, these documents are available through the OSHA Web site at http://dockets.osha.gov.
After reviewing ITIC's proposal, OSHA has decided that it needs to learn more about SDoC and the assurances behind them. Accordingly, this request is designed to obtain that information.
III. Questions on Which Comment Is Requested
OSHA is seeking information, data, and comment on SDoC generally, and the ITIC proposal specifically. OSHA is providing broad questions below to provide a framework for the public to respond to this RFI. However, you can provide comment or information on any aspect of the broad areas mentioned below and not just limit your answers to the specific questions posed. In responding to these questions, please explain the reasons supporting your views, and identify and provide relevant information on which you rely, including data, studies, articles, and other materials. Respondents are encouraged to address any aspect of the issue on which they believe they can contribute. Please briefly identify your background or qualification on the topic on which you are responding, where relevant.
Questions 1 through 7 pertain to regulatory or product approval systems that currently allow SDoCs.
1. What quality controls and procedures do equipment manufacturers/suppliers now follow to effectively perform, document, and issue SDoCs for their products?
2. What kinds of problems do product manufacturers and product users now encounter with their SDoCs and how are they resolved or addressed?
3. What kinds of products are now approved or not approved using SDoCs, and why?
4. Is there any reduction in the “time-to-market” for products? If so, how much of a reduction is there, how much is due to improvements in product safety, and what is the savings in costs to the manufacturer if SDoC is used instead of a third-party approval?
5. Do third-party product certifiers currently use SDoCs in approving products or play a role in issuing SDoCs, and if so how?
6. What kinds of testing and testing capabilities are required for using SDoCs?
7. Have there been any incidents involving “unapproved” IT equipment, or IT equipment approved through SDoC, creating hazards?
8. What has changed with respect to IT equipment in the 17 years since OSHA adopted the NRTL Program that could warrant a reconsideration of the third-party testing criterion?
9. Should OSHA consider allowing SDoC in the approval process for IT equipment, and if so, to what extent? If allowed, what restrictions, safeguards, or other requirements would be necessary to provide employers, employees, and OSHA with equivalent assurances of safety to that currently provided by NRTL testing and certification? Should OSHA require manufacturers performing SDoCs to meet all the requirements of an NRTL except independence? How, specifically, should OSHA evaluate the effects on worker safety of SDoCs versus NRTL approvals?
10. If OSHA were to adopt SDoC, should OSHA limit its use to computers, computer peripherals, and telecommunications equipment only, as suggested by ITIC, or to all IT equipment, as defined by the relevant U.S. test standard, or restrict its use to low voltage (for example, 50 volts or less) IT equipment or components? In the alternative, should OSHA allow its use for other types of equipment? If so, what criteria, requirements, or data should OSHA use to determine the types of products or components eligible for SDoCs? What types of equipment would not be suitable for SDoC?
11. What advantages or benefit would workers, employers, or OSHA derive if OSHA were to allow SDoC? What disadvantages or detriments would result? What other groups or parties would consider it beneficial or damaging, and how?
12. If allowed, should OSHA limit the use of SDoCs to particular kinds of manufacturers and, if so, what would be the selection criteria?
13. If OSHA were to adopt some form of SDoC, what kind of mechanisms would be necessary to ensure effective monitoring of manufacturers and products, and to handle complaints and product recalls?
14. Are there ways in which OSHA could incorporate the SDoC into its current process of NRTL approvals?
General Comments on SDoCs
OSHA solicits comment on any other related issues or topics that may assist in the evaluation of SDoCs and whether they can be used in a way that maintains or improves the NRTL approval process along with the safety of equipment.
Authority and Signature
This document was prepared under the direction of Jonathan L. Snare, Acting Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. It is issued pursuant to sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), Secretary of Labor's Order 5-2002 (67 FR 65008), and 29 CFR part 1911.Start Signature
Signed at Washington, DC this 26th day of October, 2005.
Jonathan L. Snare,
Acting Assistant Secretary.
1. While OSHA uses the term “NRTL approval” to describe the type of testing or certification activities performed by NRTLs, the international community often uses a different term for such activities: conformity assessment. An international guide, ISO Guide 2, defines “conformity assessment” as “any activity concerned with determining directly or indirectly that requirements are fulfilled.” Similarly, organizations such as NRTLs that perform these conformity assessments are referred to in ISO Guide 2 as “conformity assessment bodies” (CABs). Under OSHA's NRTL Program, each NRTL must perform both testing and certification functions. However, in countries such as France and Germany, testing laboratories and certification organizations (CABs) must be separate entities.Back to Citation
[FR Doc. 05-22630 Filed 11-14-05; 8:45 am]
BILLING CODE 4510-26-P