[Federal Register: November 15, 2005 (Volume 70, Number 219)][Notices] [Page 69355-69359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no05-82]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
[Docket No. NRTL03-SDOC]
RIN 1218-AC21
Nationally Recognized Testing Laboratories; Supplier's
Declaration of Conformity
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Request for information.
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SUMMARY: 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.
DATES: 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.
ADDRESSES: 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.
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.
SUPPLEMENTARY 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.
I. Background
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.
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 that 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.\1\ 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.)
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\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.
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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 taken 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.
SDoC Process
Note: 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?
SDoC Proposal
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.
Signed at Washington, DC this 26th day of October, 2005.
Jonathan L. Snare,
Acting Assistant Secretary.
[FR Doc. 05-22630 Filed 11-14-05; 8:45 am]
BILLING CODE 4510-26-P
