[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79035-79048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31695]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
[Docket No. OSHA-2008-0032]
Nationally Recognized Testing Laboratories; Supplier's
Declaration of Conformity
AGENCY: Occupational Safety and Health Administration, Labor.
ACTION: Notice.
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SUMMARY: Based on its analysis of comments received in response to a
Request for Information published in October 2008, the Occupational
Safety and Health Administration will not initiate rulemaking to permit
the use of a Supplier's Declaration of Conformity as a means of
ensuring the safety of products currently requiring approval by
Nationally Recognized Testing Laboratories.
FOR FURTHER INFORMATION CONTACT: Press inquiries: 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, Director, Office of
Technical
[[Page 79036]]
Programs and Coordination Activities, NRTL Program, Occupational Safety
and Health Administration, U.S. Department of Labor, 200 Constitution
Avenue, NW., Room N-3655, Washington, DC 20210; telephone: (202) 693-
2110. OSHA's Web page includes information about the NRTL Program (see
http://www.osha.gov, select ``N'' in the site index).
SUPPLEMENTARY INFORMATION:
I. Introduction
II. Background
A. Requirement for a High Degree of Protection for Product
Approval Standards
B. Events Leading to the Second RFI on SDoC
C. Overview of OSHA's NRTL Program
D. Overview of the EU's SDoC System
E. The EC's Formal Proposal
F. OSHA's October 20, 2008, Request for Information on SDoC
III. Summary of Findings
A. Statistical Evidence Concerning Workplace Safety under an
SDoC System
B. Analysis of the Components of an SDoC System
C. Proposed Alternatives
D. Use of SDoC in the U.S.
E. Post-Market Surveillance in NRTL v. SDoC Systems
F. The Costs of Administering an SDoC System
IV. Effects on Trade
A. Background
B. Analysis of the Trade-Barrier Issue
V. Concluding Remarks
I. Introduction
In a Request for Information published in the Federal Register on
October 20, 2008 (``2008 RFI''), the Occupational Safety and Health
Administration (``OSHA'' or ``Agency'') requested comments on a
proposal it received to permit use of a Supplier's Declaration of
Conformity (SDoC) as an alternative to OSHA's current Nationally
Recognized Testing Laboratories (NRTLs) product-approval process. (See
73 FR 62327.) OSHA received the proposal from the European Commission
(EC), which advocated an SDoC system for specific electrical products.
The European Union (EU) currently permits its Member States to use SDoC
for these products. The EC's proposal stems from its belief that SDoC
assures the safety of such products, and that OSHA's NRTL system
constitutes a technical barrier to trade.
After thorough analysis of the comments received, and due
consideration of the concerns, issues, positions, and suggestions set
forth in comments to the 2008 RFI, OSHA finds, based on the record,
that an SDoC system would not provide the high degree of protection
required by the Occupational Safety and Health Act of 1970, 29 U.S.C.
651 et seq. (``OSH Act'' or ``Act''). By this determination, OSHA is
not asserting or implying that the EU's SDoC system is deficient for
the safety purposes and goals it serves in the EU. The EU, like all
governments, must choose an approach to safety approvals that comports
with its political and legal authority and that satisfies its needs and
priorities. However, as explained in this notice, OSHA finds that the
evidence in the record does not support a conclusion that SDoC is
appropriate for U.S. workplaces, given OSHA's legal authority and
responsibilities.
NRTLs are independent (i.e., third-party) \1\ laboratories that
meet OSHA's requirements for performing safety testing and
certification of products used in the workplace. NRTLs test and certify
(i.e., approve) these products to determine whether they conform to
appropriate U.S. product-safety standards. The NRTL issues a
certificate to declare the product conforms to the particular
standard(s). In contrast, in an SDoC system, the manufacturer issues a
declaration attesting that the product meets the standard or other
requirements. This manufacturer's declaration may be based on testing
performed by the manufacturer, by a third-party, or by a user of the
product. The EU's SDoC system allows manufacturers to rely on, but does
not require, third-party testing. Manufacturers are responsible for
maintaining a written declaration of conformity or other allowable
evidence of conformity, and a technical file demonstrating that the
manufacturer tested the product to assure conformity with the
requirements specified in the applicable EU directive. (See section
II.D of this notice, for more information.) Under SDoC, regulatory
authorities must also have a system to audit, and to bring enforcement
action against, product manufacturers and, possibly, product
distributors, including retailers. In some cases, as in the EU, such a
system involves post-market surveillance, under which the authority
checks the conformity of products after they are already sold in the
market. Several U.S. Federal agencies allow SDoC for the specific
products they regulate.
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\1\ A third-party system is one of the three types of systems
generally used for an attestation of conformity (i.e., attesting
that certain requirements are met). The other types are first-party
attestation, which is issued by the supplier (e.g., a manufacturer),
and second-party attestation, which the user issues.
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The 2008 RFI is OSHA's second RFI addressing SDoC. The Agency
issued a similar RFI in 2005 (``2005 RFI'') in response to a proposal
from an industry trade association for OSHA to use an SDoC system for
information technology products. Much of the information submitted by
the commenters in response to the 2005 RFI lacked the supporting data
and details requested, or lacked adequate support or explanations for
the data cited. OSHA found that the information provided by the
commenters did not justify a decision to initiate rulemaking to adopt
an SDoC system. Furthermore, OSHA believed that it lacked the legal
authority and resources to adopt many of the enforcement measures
required for an SDoC system, including product recalls, bans, and
confiscation, among other measures. In view of these findings, which
address only a few key areas of concern, OSHA decided to take no
further action on the trade association's proposal, and announced its
decision in the Spring 2007 Semi-Annual Regulatory Agenda, published on
April 30, 2007. (See 72 FR 22870-02.) For more information on this
matter, see the discussion of the 2005 RFI in the introduction to the
2008 RFI (73 FR 62328-29).
OSHA seldom publishes a notice discussing the results of an RFI. It
is issuing a notice in this case because of the unique and complex
issues involved, and, as a result, to provide interested parties with
details on OSHA's reasoning on this decision. OSHA did not provide such
rationale when it announced its decision on the 2005 RFI. In this
Federal Register notice, OSHA provides a summary of the 2008 RFI, a
discussion of its analysis of the comments to the RFI and the trade
issues involved, and its conclusion. The Background section begins with
a discussion of the OSH Act's standard-setting requirements, and then
describes the events that led to the publication of the 2008 RFI. Next,
the Background section provides an overview of both OSHA's NRTL Program
and the EU's SDoC system, followed by the EU's rationale for its
proposal and a discussion of the 2008 RFI.
II. Background
A. Requirement for a High Degree of Protection for Product-Approval
Standards
The primary purpose of the OSH Act is to assure, so far as
possible, safe and healthful working conditions for every American
working man and woman. (See 29 U.S.C. 651(b).) To fulfill this purpose,
Congress gave the Secretary of Labor the authority to promulgate,
[[Page 79037]]
modify, and revoke mandatory occupational safety and health (OSH)
standards.\2\ (See 29 U.S.C. 655.) The Act, and the case law developed
under it, establish a number of requirements that OSHA must meet before
exercising this authority. Some of these requirements are procedural.
For example, OSHA must support its findings with substantial evidence
in the record developed through the rulemaking proceedings, and explain
the basis for accepting or rejecting major suggestions for modification
of a proposed OSH standard. (See, e.g., ``Supplemental Statement of
Reasons'' for the final rule on Control of Hazardous Energy Sources, 58
FR 16612 at 16621; see also 29 U.S.C. 655(b) and (f).) In addition,
when OSHA decides to revise an OSH standard, it must provide a reasoned
basis for the revision. (International Union, UAW v. OSHA, 37 F.3d 665,
669-70 (DC Cir. 1994) (``Lockout/Tagout II'').)
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\2\ OSH standards contain requirements that are imposed on
employers for ensuring safety and health in the workplace. They are
different from a test standard, which we describe later in this
notice, and which specify technical requirements that products must
meet.
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OSHA also is constrained by substantive rulemaking requirements.
The OSH Act requires that safety standards, like the NRTL product-
approval (or product-conformity) requirements, must provide ``a high
degree of worker protection.'' (Lockout/Tagout II, 37 F.3d at 669
(quoting ``Supplemental Statement of Reasons'' for the final rule on
Control of Hazardous Energy Sources, 58 FR 16612 at 16615).) Thus, for
OSHA to adopt an SDoC system, it must find, on the basis of substantial
evidence, that the SDoC product-approval system provides a high degree
of protection to workers who use equipment that would be covered by the
standard. The ``high degree of protection'' requirement allows OSHA to
``deviate only modestly from the stringency required by section 6(b)(5)
for health standards,'' which must eliminate significant risk, or
reduce that risk to the maximum extent feasible. (Lockout/Tagout II, 37
F.3d at 669.) In this regard, OSHA is careful to ensure that
modifications to its approach for product conformity maintain the
required high degree of worker safety. (See 53 FR 12103.)
OSHA considered two approaches to determine whether an SDoC system
would provide a high degree of protection. One approach is to examine
whether there are valid statistical data that show a direct correlation
between a method of protection and low rates of illness or injury.
Another approach is to examine qualitatively the operation, attributes,
and elements of the system to determine whether it is likely to provide
a high degree of protection. By way of illustration, consider the use
of a warning alarm on equipment that operates near power lines to
provide adequate warning of possible contact with a line. Having valid
statistical data demonstrating that such an alarm measurably reduces
these types of contacts and resulting injuries could provide a basis
for concluding that requiring the alarm would provide a high degree of
worker protection. OSHA then would consider proposing a requirement
that employers working near power lines install such alarms on cranes
or other equipment that could contact these lines. Alternatively, OSHA
could examine the method's operation and attributes. If the operation
of the alarm under prescribed conditions showed that it consistently
provides a timely warning, OSHA could conclude that requiring the alarm
would contribute toward providing a high degree of worker protection,
and could consider including it in a proposed rulemaking. However, if
the elements of a method provided little or no assurance of
safeguarding against a hazard, the method would not provide a high
degree of worker protection. For example, if the alarm failed to
operate in a predicable manner, and if safety testing provided
inconsistent results, then OSHA would not have confidence that the
alarm would contribute toward providing the required high degree of
worker protection.
As discussed later in this notice, commenters to the 2008 RFI did
not submit to the record valid statistical data for determining the
degree of protection afforded by an SDoC system. In this regard, OSHA
found that the data submitted to the record did not demonstrate the low
risk of injury claimed for an SDoC system by its proponents. In
addition, OSHA analyzed the elements of the SDoC system to determine
whether these elements would provide assurance of a high degree of
worker safety; this analysis showed that the elements of the SDoC
system did not provide such assurance. We discuss the results of this
analysis in Section III (``Summary of Findings'') below.
B. Events Leading to the Second RFI on SDoC
On April 30, 2007, President Bush and his EU counterparts signed
the Framework for Advancing Transatlantic Economic Integration Between
the U.S. and the EU (``Framework Understanding'' or ``Framework'').
(Exhibit OSHA-2008-0032-0002.) This trade-related understanding has a
number of objectives, the foremost of which is ``removing barriers to
transatlantic commerce.'' (See section II of the Framework.) The
Framework's Annex 1 lists a number of activities affecting different
U.S. and EU agencies and sectors, including ``initiating an exchange on
conformity assessment \3\ procedures for the safety of electrical
equipment.''
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\3\ While OSHA uses the term ``approval'' to describe the type
of testing and certification activities performed by NRTLs, the
international community often uses the term ``conformity
assessment'' to describe these activities. ISO Guide 2 defines
``conformity assessment'' as ``any activity concerned with
determining directly or indirectly that requirements are
fulfilled.''
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The Framework established a Transatlantic Economic Council (TEC) to
monitor and advance progress toward meeting the goals of the Framework.
As stated in the Framework, the TEC is ``co-chaired, on the U.S. side,
by a U.S. Cabinet-level official in the Executive Office of the
President and on the EU side by a Member of the European Commission,
collaborating closely with the EU Presidency.'' (See section IV of the
Framework.) Through the TEC, in July 2007, the EC issued a brief
statement proposing that OSHA adopt SDoC for ``electrical and ICT
equipment,'' claiming that this action would ``reduce unnecessary costs
for transatlantic trade.'' (Exhibit OSHA-2008-0032-0003.)
Working in part through the TEC, OSHA and the EC arranged a meeting
to exchange information on conformity-assessment procedures for the
safety of electrical equipment. The meeting was held on October 11,
2007. A summary of this meeting describes the key elements of each
party's respective NRTL and SDoC systems. (Exhibit OSHA-2008-0032-
0004.) At a subsequent meeting on November 9, 2007, the TEC issued a
joint statement requesting OSHA to report, at the TEC's next meeting,
on ``progress made to facilitate trade in electrical products with
respect to conformity assessment procedures for the safety of such
products.'' (Exhibit OSHA-2008-0032-0009.) In March 2008, the EC issued
another statement asking the ``[U.S.] Government to allow the import
and sale of any low-risk electrical and electronic product on the
basis'' of an SDoC.\4\ (Exhibit OSHA-2008-0032-0005.)
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\4\ OSHA does not regulate the ``import and sale'' of products,
but its rules do affect whether employers may use specific products
in the workplace, thus affecting, to some degree, whether those
products may be sold or imported into the U.S.
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[[Page 79038]]
At the second formal TEC meeting, held on May 13, 2008, the
Secretary of Labor announced that OSHA would issue a second RFI on
SDoC. (Exhibit OSHA-2008-0032-0009.) This second RFI would improve
OSHA's understanding of SDoC and other related topics and issues not
fully explored in the 2005 RFI. In June 2008, at OSHA's request, the EC
submitted a formal rationale for its proposal that OSHA permit SDoC for
electrical products.\5\ During these events, OSHA noted that it
received no convincing information demonstrating that NRTL approval and
program requirements are barriers to trade. Section IV (``Effects on
Trade'') of this notice explains OSHA's position on these trade issues.
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\5\ While the EC distinguishes between electrical and electronic
products, such products are electrical products for purposes of
OSHA's approval requirements.
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C. Overview of OSHA's NRTL Program
Since its inception, OSHA has required that electrical and other
types of equipment be approved by qualified organizations as one means
to ensure the safety of this equipment. Pursuant to the OSH Act, OSHA
based this requirement on available consensus codes and standards. The
requirements for NRTL approval of electrical equipment are detailed in
29 CFR 1910, subpart S. The provisions of this subpart require approval
\6\ of most electrical equipment used in the workplace. The purpose of
the requirements is to ensure that the electrical products will, when
used in the workplace, provide workers with a high degree of protection
from the hazards associated with use of these products.
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\6\ That is, ``accepted, or certified, or listed, or labeled, or
otherwise determined to be safe'' by an NRTL, as defined in 29 CFR
1910.399.
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Following its normal rulemaking process, OSHA published a rule on
April 12, 1988 that established the NRTL Program. (See 53 FR 12102.)
The rule implements the elements of OSHA's product-approval approach,
and requires that a testing laboratory must satisfy the following
requirements to be recognized by OSHA as an NRTL: (1) Have the
capability to perform the required testing; (2) have controls and
services for assuring that tested equipment conforms to the appropriate
test standards; (3) be independent from manufacturers, suppliers and
vendors of tested products, and from other employers; and (4) have
procedures for producing credible findings and reports, and for
handling complaints. (See 29 CFR 1910.7, 53 FR 12102.)
OSHA found that each of these requirements was necessary to ensure
that workers are safe when working with or exposed to electrical
equipment. The capability requirement ensures that the NRTL has the
requisite expertise to test specific products to the applicable
standards. ``Each NRTL's capability must be demonstrated in relation to
the specific product being tested, the testing standards, methods and
procedures being used * * *, and the quality of engineering decision
making needed to reach a workplace safety determination for the
product.'' (See 53 FR 12107.)
NRTLs also must conduct continued oversight of certified products
to ensure that the products continue to conform with the test standard
as production proceeds. Specifically:
This part of the definition of NRTL has three elements: The
implementation of control procedures for identifying the listed or
labeled equipment; production line inspection to assure [continued]
conformance with the test standard; and * * * post-marketing field
inspections to monitor and assure proper use of the mark or label.
(Id.) Each of these three elements provides assurance that all units of
the products approved by the NRTL continue to provide the same high
degree of protection as the unit or prototype tested and certified
initially by the NRTL.
The independence requirement is a particularly important component
of the NRTL Program. ``Absent the direct involvement of OSHA in testing
laboratory decision making, this independence requirement is necessary
to assure the integrity of the testing activities.'' (Id.) Thus, the
independence requirement protects against self-dealing that may arise
when an entity certifies a product it manufactures.
Implementing adequate internal controls also is critical to the
NRTL Program. Each NRTL must establish internal controls to ensure that
it produces credible findings and reports to support its certification
determinations, and each NRTL must have set procedures for handling
complaints and disputes. These controls provide assurance that the
NRTL's testing and certification process is reliable.
To satisfy the approval requirement when an employer uses a product
in the workplace, the NRTLs generally must approve the product for the
manufacturer before the manufacturer initially sells or ships the
product. An NRTL performs two major functions in the product-approval
process: Testing and certification. First, the NRTL tests a
representative unit or prototype of the product to ensure it meets the
requirements of the applicable product safety-test standard(s). For
this purpose, the NRTL may rely on testing that it conducted, or it may
accept testing performed by parties that the NRTL qualifies for that
purpose. These parties typically include independent testing
laboratories, but also may include the product's manufacturer, which
results in time and cost savings for a qualified manufacturer. Second,
the NRTL authorizes the manufacturer to apply the NRTL's mark on the
product, indicating that the product meets the requirements of the
appropriate test standard(s). To ensure that the product continues to
comply with the applicable requirements, and that the manufacturer is
conducting production-line tests on the product required by the test
standard(s), the NRTL will conduct follow-up inspections on a regular
basis at each of the product manufacturer's factories or assembling
facilities. NRTLs typically conduct these follow-up inspections two to
four times per year at each facility. The NRTL may use a contractor
under the NRTL's control to conduct these inspections.
OSHA's NRTL Program recognition process involves a thorough
analysis of an NRTL applicant's policies and procedures, and a
comprehensive onsite review of the applicant's testing and
certification facilities, to ensure that the applicant meets these
requirements. OSHA's staff also conduct annual onsite audits at each
NRTL's facilities to ensure that the NRTLs adequately perform their
testing and certification activities, and maintain the quality of these
operations. Thus, through the NRTL Program, OSHA ensures that a
qualified, independent testing laboratory certifies the equipment
before it reaches the market.
In adopting the program's requirements, OSHA found that
implementation of these criteria and procedures would ``assure no
diminution of worker safety.'' (53 FR 12103.) Since implementation,
OSHA received no evidence challenging this conclusion or the conclusion
that the NRTL product-approval requirements provide the high degree of
worker protection required by the OSH Act.
D. Overview of the EU's SDoC System \7\
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\7\ Except as noted, the information in this section comes from
the summary of the October 11, 2007, information-exchange meeting
between OSHA and EC representatives (Ex. OSHA-2008-0032-0004) and
research by OSHA staff.
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The Low Voltage Directive (``LVD'' or ``Directive'') determines
which products are covered by the EC's SDoC system for electrical
safety (Exhibit OSHA-2008-0032-0017); the EC implemented it in 1973 to
promote the free movement of goods across the EU. (The LVD does not
[[Page 79039]]
apply to goods exported to countries outside the EU.) Directives are
laws binding on the Member States enacted by the European Council and
European Parliament. Generally, under the EU's system, the EC proposes
these laws. (More information on these institutions and their functions
is available at http://europa.eu/index_en.htm.) The LVD covers all
equipment between 50 and 1,000 volts AC, and 75 and 1,500 volts DC,
except as specifically excluded in Annex II of the LVD. This annex
lists, among other types of equipment, ``electrical equipment for use
in an explosive atmosphere, those for radiology and medical purposes,
and those for goods and passenger lifts.'' The lower and upper limits
of the LVD were set to exclude electrical equipment of the
telecommunication industry and electric-power industries, respectively.
The EC's proposal asserts that all products covered under the LVD in
the EU are ``low-risk'' because electrocutions have become rare in the
EU since implementation of the LVD; the EC concludes that the low rate
of electrocutions demonstrates the effectiveness of the EC's SDoC
system. In general, the conformity-assessment approach used in the EU
classifies products according to eight categories, with requirements
ranging from the least stringent (Module A) to the most stringent
(Module H). Module A, covering only the purportedly lowest-risk
products, is the only category to which SDoC alone applies, i.e.,
without other and stronger regulatory controls. (See Exhibit OSHA-2008-
0032-0015 for an illustration of the safety requirements for products
covered by each module.)
The Member States enforce the LVD through post-market surveillance.
Each EU Member State must enact national laws to implement the LVD, and
assign at least one agency (the ``surveillance authority'') to enforce
these laws. In the United Kingdom, for example, approximately 250 local
government agencies perform this function, whereas in other countries,
one agency or one part of an agency may fill this role. The
surveillance authority's inspections are a critical activity. Among the
EU countries, the type and number of inspections vary depending on the
number of available inspectors, the level of funding, and the type and
number of problems prevalent in the Member State. Some Member States
base inspections primarily on complaints and accidents, while other
Member States base inspections primarily on a random selection of
products. (See Exhibit OSHA-2008-0032-014, p. 40.) Once an inspection
identifies a potential deficiency, the surveillance authority may
require the manufacturer, if known, to submit to the authority a report
by an independent testing organization (referred to as a ``notified
body'' in the EU) demonstrating that the product conforms to the
applicable test standard. For products that do not conform, the
manufacturer must perform a risk assessment and propose corrective
actions. Ultimately, the surveillance authority makes a final decision
on risk, which can vary substantially across countries. The authority
then decides what remedial action to take, which may include a product
recall, ban, quarantine, or confiscation; assessing financial
penalties; and, in more serious cases, assessing criminal penalties. If
the authority cannot locate the manufacturer or its authorized
representative, the authority may hold the retailer (or other party
that places the product in that Member State's market) responsible, and
impose the remedial action on that party.
For products posing immediate safety risks and affecting more than
one Member State, the EU has a rapid alert system (RAPEX). Another
notification system, ICSMS, also serves this purpose, but not every EU
Member State uses ICSMS. The goal of recently promulgated EU
legislation is to harmonize the notification systems used by the Member
States.
Manufacturers must maintain technical files of products covered
under the LVD for at least 10 years ``after the last product has been
manufactured.'' Under the LVD, a technical file must contain evidence
that the product complies with the applicable safety standards or other
requirements, either through accredited tests, or through other
evidence such as a manufacturer's comprehensive safety analysis of the
product's design. Bodies called ``European Standardisation
Organisations'' (ESOs) are responsible for developing and maintaining
the technical safety specifications for the products (commonly referred
to as the ``product safety test standard'' or ``test standard''). In
addition, market-surveillance authorities accept products that conform
to the ESO standards as being in compliance with the LVD. If challenged
by a Member State's surveillance authority, a manufacturer must prove
that it complied with the LVD, either by demonstrating compliance with
the ESO standard or by other means. If the manufacturer is unknown, the
burden of demonstrating compliance passes to the importer, which can be
liable for penalties and applicable fines. However, there is no
requirement that manufacturers or importers register with any Member
States, making it difficult in some cases to identify the responsible
party.
EU Member States cannot add safety-related requirements to the LVD.
The LVD is binding on each Member State, which must codify it into
national laws. If a Member State does not properly implement the LVD
through legislation, it must nonetheless accept products declared by
the manufacturers to comply with the Directive unless available
evidence demonstrates that the products are noncompliant. Each Member
State is responsible for imposing fines on manufacturers or importers
for noncompliance with the LVD.
E. The EC's Formal Proposal
In its statement of March 2008 (Exhibit OSHA-2008-0032-0005), the
EC called for OSHA to adopt an SDoC system, and supplemented this
statement in its June 2008 rationale (Exhibit OSHA-2008-0032-0008),
which formally requested that OSHA ``review its conformity assessment
procedures in the area of electrical and electronic products.''
According to the March 2008 statement, the EC advocated an SDoC system
because it believes third-party conformity assessment of ``low-risk
electrical and electronic products'' in the U.S. ``imposes unnecessary
additional costs and market-entry barriers on exporters of these goods
* * * .'' The statement describes the types of products the EC
considers to be outside the scope of its `` `low-risk electrical and
electronic product' definition,'' such as ``electrical equipment for
use in an explosive atmosphere, * * * for radiology and medical
purposes, * * * [and] electricity meters, plugs, and socket outlets for
domestic use * * * .'' The statement noted that such products present a
level of risk that makes SDoC an inappropriate means of conformity
assessment under EU law, and that the EU requires the use of third-
party approvals in such cases.
In its June 2008 rationale, the EC noted that it has extensive
experience with conformity-assessment regimes that do not require
manufacturers to obtain third-party certification. The EC based its
choice of an SDoC regime on its ``assessment of the risk to consumers,
workers and the general interest that non-compliant products would
reach the market place that would pose danger.'' The EC then concluded
that the risks for these products ``are at a level that they can be
satisfactorily managed by obliging manufacturers to demonstrate
compliance and to keep such proof at the disposal of public
[[Page 79040]]
authorities for inspection at all times.'' According to the EC
statement, such rules, along with product liability law, consumer
protection legislation, and appropriate enforcement measures guarantee
a high level of safety for European consumers.
Also in the June 2008 rationale, the EC contends that OSHA's third-
party requirements cause an ``imbalance in market access regimes
governing transatlantic trade in electrical products,'' and an
``imbalance in market access for the certification industry as U.S.
certifiers can without any barrier offer their services to U.S.
industry to comply with EU rules, whereas EU certifiers require either
recognition as an NRTL by OSHA or be accepted as a test house by
NRTLs.'' \8\ According to the EC, these requirements increase the
likelihood that countries importing products from the U.S. and the EU
will establish different forms of testing and approval. The EC asserted
that having OSHA adopt an SDoC system ``is justified by the fact that
European consumers and workers experience a high if not higher level of
electrical safety as their counterparts in the U.S.'' It attributes
this effect in part to ``the high level of safety of electrical and
electronic devices.'' Moreover, the EC contends that ``[s]tatistics
furthermore demonstrate that accidents can seldom be attributed to
products, but are normally the result of `live' wires and neglect.
Where they can be attributed to products, there are no indications that
in the EU there is a relationship between non-compliance and
incidents.'' Finally the EC claims that ``market mechanisms ensure that
most electrical and electronic products and especially high technology
products and high volume products follow rigid quality controls and
have an excellent record of compliance.''
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\8\ See discussion under section IV of this notice.
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F. OSHA's October 20, 2008, Request for Information on SDoC
In the 2008 RFI, OSHA posed 45 questions to elicit information OSHA
needed to decide whether to initiate rulemaking to allow an SDoC system
for ensuring a high degree of safety for electrical products in the
workplace. OSHA stressed the importance of ``specific detailed
scientific, technical, statistical or similar data and studies, of a
credible nature, supporting any claims made by commenters.'' (73 FR
62327.) OSHA requested information and comments from all interested
parties on the issues raised in the RFI, or any other issues the public
deemed relevant for OSHA's consideration.
In addition, OSHA specifically noted that the EC's proposal and
rationale lacked sufficient evidence to support its contention that the
safety risk of noncompliance was low under its LVD. Accordingly, in the
2008 RFI, OSHA requested evidence to support the EC's assertion that
European consumers and workers ``experience a high if not higher level
of electrical safety as their counterparts in the U.S.'' without the
safeguards required under the NRTL Program. (See 73 FR 62331 (quoting
Exhibit OSHA-2008-0032-0008).) OSHA noted that it would need data in
support of the EC's assertions regarding the safety of its SDoC system
to enable OSHA to determine whether adopting an SDoC system in the U.S.
would provide U.S. workers with the high degree of worker protection
required by the OSH Act.
During the 90-day comment period, OSHA received 74 comments in
response to the RFI. The relevant issues raised in these comments are
discussed in Section III of this notice.
III. Summary of Findings
As noted earlier, two conceptual approaches applicable for
evaluating the safety of a conformity-assessment system, such as SDoC,
are: (1) An evaluation of statistics concerning the system's safety
record, and (2) an evaluation of the operations and elements of the
system. In subsections A and B of this section, OSHA analyzes the
evidence \9\ submitted using each of these approaches. OSHA finds that
the record does not support the conclusion that, under either approach,
SDoC would provide a high level of worker protection against the
hazards of electrical equipment in U.S. workplaces.
---------------------------------------------------------------------------
\9\ When multiple commenters raised a similar issue discussed in
this notice, OSHA addresses the issue, but does not necessarily
identify every commenter that raised the issue.
---------------------------------------------------------------------------
The remainder of Section III addresses other arguments about SDoC
raised in the record. Specifically, OSHA addresses alternative
approaches recommended by commenters (subsection C), arguments relying
on manufacturer-certification schemes used for other products in the
U.S. (subsection D), arguments based on post-market surveillance
required under each of the schemes (subsection E), and the costs of
administering an SDoC system (subsection F). As discussed in detail
below, OSHA decided that the record does not justify initiating a
rulemaking to adopt SDoC for assuring the safety of electrical products
used in the workplace.
A. Statistical Evidence Concerning Workplace Safety Under an SDoC
System
No commenter submitted valid statistical data to the record, nor
did OSHA find any such data, that demonstrate that SDoC presented the
low risk claimed by its proponents. Indeed, commenters agreed that data
do not exist, either in the U.S. or in Europe, to accurately
differentiate between the safety of electrical equipment approved by a
third party and products not approved by a third party. (See, e.g.,
Exhibits OSHA-2008-0032-0044.1 at 8, 25; OSHA-2008-0032-0019; OSHA-
2008-0032-0031.1; OSHA-2008-0032-0089.1; OSHA-2008-0032-0092.1.)
Moreover, the limited EU and U.S. workplace statistics that are
available, while not conclusive, raise concerns about the relative
safety of an SDoC system. For the year 2005, the most recent available
for both jurisdictions, U.S. Bureau of Labor Statistics show that 510
private-sector employees had injuries that caused them to be away from
work for three or more days from ``contact with electric current of
machine, tool, appliance, or light fixture.'' \10\ A total of 1,960
employees had injuries causing them to be away from work for three or
more days for ``contact with electric current.'' According to EC's
Directorate General for Employment, Social Affairs, and Equal
Opportunities, a total of 1,584 employees sustained injuries at work
causing them to be away from work for more than three days from
``electrical problem due to equipment failure,'' and a total of 5,510
employees sustained the same degree of injuries from ``direct contact
with electricity, receipt of electrical charge in the body.'' European
Commission, Directorate-General for Employment, Social Affairs, and
Equal Opportunities, Causes and Circumstances of Accidents at Work in
the EU, at 172-73 (2009) (``DG Report''; available at http://ec.europa.eu/social/main.jsp?catId=787&langId=en (last accessed 7/20/
10) (hereafter EU Workplace Statistics Report).
---------------------------------------------------------------------------
\10\ These statistics are taken from the Bureau of Labor
Statistic's database of Occupational Injuries and Illnesses and
Fatal Injuries Profiles, which may be accessed at http://data.bls.gov:8080/GQT/servlet/InitialPage (last viewed 7/20/10).
---------------------------------------------------------------------------
BLS statistics show that, in 2005, there were roughly 111 million
private-sector employees in the U.S. See BLS Employment Situation, July
2005 & December 2005 (available at http://www.bls.gov/schedule/archives/empsit_nr.htm#2005, last accessed on 7/20/10). These
statistics yield an incidence rate per 100,000 workers of 0.46 for
[[Page 79041]]
equipment-related electrical injuries (>=3 days lost), and 1.76 for all
electrical injuries (>=3 days lost). The corresponding population of EU
workers is more difficult to determine because the DG Report gives
numbers ranging from 106 million to 183 million, EU Workplace
Statistics Report at 117; however, using the most favorable number for
the EU, this yields an incident rate per 100,000 workers of 0.87
injuries (> 3 days) due to ``electrical problem due to equipment
failure,'' and 3.01 injuries (>3 days) due to direct contact with
electricity. These data are summarized in Table 1 below.
Table 1--U.S. Private-Sector and EU Electrical Injuries 2005
------------------------------------------------------------------------
Injuries/
Injuries 100,000 wkrs
------------------------------------------------------------------------
U.S.--Contact with electric current of 510 0.46
machine, tool, appliance, or light
fixture, (private-sector injuries >= 3
days away from work)...................
U.S.--Contact with electric current, 1,960 1.76
(private-sector injuries >= 3 days away
from work).............................
EU--Electrical problem due to equipment 1,584 0.87
failure, (injuries > 3 days lost)......
EU--Direct contact with electricity, 5,510 3.01
receipt of electrical charge in the
body, (injuries > 3 days lost).........
------------------------------------------------------------------------
There are obvious problems involved with directly comparing the
above data. BLS based this data on a survey of employers required to
record occupational injuries on logs maintained for this purpose; the
EU statistics are a compilation of member country data which is
collected, depending on the country, either from insurance claims or
reports by employers adjusted to account for non-reported injuries. The
EU records only data concerning injuries that result in more than three
days lost; the published U.S. data include injuries resulting in three
or more days lost. It is unclear whether the EU classification
``electrical problem due to equipment failure'' is equivalent to the
U.S. category ``Contact with electric current of machine, tool,
appliance, or light fixture.'' Regardless, the numbers do not directly
measure injuries due to nonconforming electrical products. Nonetheless,
the fact that the EU workplace electrical injury \11\ rates for 2005
were nearly twice the rates for the U.S. suggests caution in
considering whether to adopt the EU's electrical-product conformity
scheme.
---------------------------------------------------------------------------
\11\ The EU report also gives a fatality number, but it is
difficult to interpret because it is given for the period 2003-05.
The number of member states reporting deaths for these
classifications varied over this period, and, thus, these numbers
are not comparable to the U.S. data. See EU Workplace Statistics at
118.
---------------------------------------------------------------------------
Other injury data submitted to the record also gives OSHA pause.
The EC submitted the statistics from the European Injury Database
(IDB), which compiled accident and emergency data from ``selected
member state hospitals'' in Austria, Denmark, France, and Sweden for
2002-05, and from the UK and Ireland for 2002. (Exhibit OSHA-2008-0032-
0044.1, Annex 5.) The IDB data show substantial numbers of injuries
related to the use of consumer electrical products which are subject to
a SDoC system: 6,115 injuries involving all electrical products, and
1,721 injuries involving ICT products. Although its methodology is not
clear, the EC claims that, at most, 1,243 injuries involved electrical
product nonconformance, and 325 injuries involved nonconforming ICT
equipment.\1/2\ These are substantial numbers, especially given the
limited geographic and temporal scope of the data; accordingly, these
numbers do not support moving to an SDoC system.
---------------------------------------------------------------------------
\12\ The EC submission does not directly state the total number
of accidents in the IDB. However, Annex 5 of the EC submission
states that the 1,721 accidents attributed to ICT equipment
constitute 0.18% of the accidents in the IDB, indicating that the
total number of accidents was 956,111 (i.e., 0.0018 x 956,111 =
1,721). The EC argues that these data should be analyzed as a
percentage of all injuries, rather than an absolute number. OSHA
does not agree with this argument because a small percentage of
injuries may mask the magnitude of the injuries, which is best
expressed as an absolute number. OSHA is concerned about the risk
posed by electrical equipment, not the comparison of electrical
equipment injuries to other types of injuries in the EU.
---------------------------------------------------------------------------
The remaining statistical evidence provided by commenters was
unconvincing. Although some proponents claimed that the data they
submitted supported the safety of SDoC, they failed to submit source
data or published studies to verify the statistics they cited. (See,
e.g., Exhibits OSHA-2008-0032-0041.1 and OSHA-2008-0032-0051.) In
addition, commenters often failed to explain adequately the methodology
underlying the statistics they provided. (See, e.g., OSHA-2008-0032-
0053.1.) Commenters also failed to address the limitations that OSHA
described in Section IV of the 2008 RFI with respect to some items of
information it previously received. For example, they failed to address
adequately how SDoC controls the risks associated with non-compliant
products. (See, e.g., OSHA-2008-0032-0089.1.) Consequently, as
discussed below in further detail, OSHA found unconvincing the data
submitted to the record supporting the safety of products under an SDoC
system.
An example of an unsupported claim in the record was a statement by
the EC that the only electrical product to cause a fatal accident in
the EU in the last 10 years was a steam iron tested by a third party,
but modified during production, (Exhibit OSHA-2008-0032-44.1 at 8, 25).
This comment did not explain what databases or records it searched to
locate information about deaths from electrical products, nor is it
clear that the EU surveyed all of the available sources of data.
Published workplace statistics, noted above, show that EU workers had
thousands of non-fatal accidents in 2005, and hundreds of fatal
accidents between 2003 and 2005 related to contact with electricity or
other electrical problems. (See EU Workplace Statistics Report at 172-
73) Further, the steam-iron incident highlights the fact that the EU's
SDoC system is not designed to prevent defective products from reaching
the market because the surveillance authorities conduct few, if any,
factory inspections to ensure that manufacturers continue to comply
with the applicable safety requirements before products are sold or
shipped. This point is discussed further in subsection II.B.1 below.
The EC also pointed to RAPEX data as evidence of ``pre-emptive''
measures taken by EU Member States to remove noncompliant products from
the market. (Exhibit OSHA-2008-0032-44.1 at 8-9.) The EU's RAPEX is a
system used by market-surveillance authorities to report sales bans,
recalls, or orders to modify products they have issued. EU Member
States use RAPEX for a number of ``non-food consumer products,'' but do
not typically use it for products having mainly industrial or
commercial purposes. Member States also do not use RAPEX for
notification of noncompliant products when ``the effects do not or
[[Page 79042]]
cannot go beyond the territory of a Member State * * *.'' (Exhibit
OSHA-2008-0032-0017.) As a result, Member States may judge a number of
actions that are of interest to OSHA to be outside the scope of RAPEX
and, thus, not report them. Therefore, RAPEX results likely do not
accurately capture the problems associated with some products,
particularly products used in the workplace. Further, these
notifications represent instances of noncompliant products reaching the
market. As discussed in more detail below, this is a central feature of
the EU's SDoC system that raises critical concerns for OSHA: an SDoC
system detects nonconforming products only after products reach the
market. These RAPEX data do not demonstrate that the EU's reactive SDoC
system has the necessary elements to provide a high degree of worker
protection for electrical safety in the U.S. workplace.
Several commenters cited a graph showing the number of fatalities
from electrical incidents in the U.S. and Germany as evidence that such
incidents are decreasing more rapidly in the EU than in the U.S. (See,
e.g., Exhibits OSHA-2008-0032-0044.1, Annex 4; OSHA-2008-0032-0045.1;
OSHA-2008-0032-0054.1; OSHA-2008-0032-0060.1; OSHA-2008-0032-0087.1.)
However, as OSHA noted in the 2008 RFI, ``[t]he source of the data does
not appear to be readily available in the U.S., the actual numbers of
electrocutions per year and a stratification by causes are not provided
in the graph, no reason is given why more recent data were not
obtained, and it is unclear whether the data are normalized for the two
populations.'' (73 FR 62320.) No commenters responded to these issues.
The Confederation of Danish Industry, while conceding that the
question of whether SDoC is less safe than a third-party system is
``difficult to answer,'' provided information showing that accidents
with electrical equipment and installations trended downward from 1998
to 2007. (Exhibit OSHA-2008-0032-0089.1.) Similarly, a report from the
Swedish National Electrical Safety Board provided statistics showing
that the ``number of products possessing a serious criticism risk has
[been] reduced and the number of sales bans [also] have [been]
reduced'' from 1996 to 2006. (Exhibit OSHA-2008-0032-0092.1.) However,
these statistics do not address directly the safety of these products
in terms of fatalities and injuries, and, therefore, do not demonstrate
that SDoC provides a sufficient level of worker protection to satisfy
the requirements of the OSH Act.
Finally, several commenters argued that ICT equipment presents a
low risk of workplace injuries. (Exhibits OSHA-2008-0032-0019; OSHA-
2008-0032-0031.1; OSHA-2008-0032-0041.1; OSHA-2008-0032-0057.1.) The
submitted data, however, did not adequately support this position. For
example, a joint ICT industry submission presented numerous statistics
demonstrating a decline in fatalities, injuries, and illnesses in U.S.
workplaces since 1972 (although illness data would appear to be
irrelevant), and also showing a relatively low rate of incidents
associated with ICT equipment in the U.S. (Exhibit OSHA-2008-0032-0019,
p.3.) These data do not demonstrate the safety of an SDoC system
because OSHA required NRTL approval of electrical products in U.S.
workplaces for most of the time period involved; the data instead
appear to support the effectiveness of the NRTL Program in preventing
workplace fatalities and injuries. As another example, the Federation
of French Electrical Electronic and Communication Industry stated that
``Certain product groups * * * are in many cases inherently safe,''
(Exhibit OSHA-2008-0032-0041.1, p.7) but provided no technical or other
information to justify its claim.
Hewlett-Packard Company stated that ``the data currently under the
product category `computer equipment' available on the United States
Consumer Product Safety Commission (CPSC) Web site indicates there has
not been a single recall for desktop personal computers, workstations,
or servers dating back to 1990.'' (Exhibit OSHA-2008-0032-0031.1) This
statistic, however, covers only a narrow subset of ICT equipment, and
excludes laptop computers and computer peripherals such as printers,
scanners, monitors, and fax machines. A review of CPSC recalls for ICT
equipment between 2003 and March of 2009 shows a total of 60 product
recalls, including laptop computers, scanners, monitors, printers,
computer speakers, fax machines, and telephones. (See http://www.cpsc.gov/cpscpub/prerel/prerel.html.) Included with these recalls
were reports of electric shock and product overheating that resulted in
property damage and personal burns. (Id.) Moreover, in March 2009
(shortly after the 2008 RFI comment period closed), there was a recall
of a desktop personal computer for overheating as a result of short
circuiting; the overheating melted internal components and the external
casing. (Id.)
In sum, the record contains no statistically sound evidence
demonstrating that an SDoC system provides a high degree of protection
for electrical safety in the workplace, and what evidence there is
raises concerns that the SDoC system may be less protective than the
NRTL system.
B. Analysis of the Components of an SDoC System
OSHA carefully reviewed the elements of the SDoC system. OSHA's
analysis concluded that, for electrical safety, the system does not
provide the high level of worker protection required by the OSHA Act.
This statement would apply to any similar SDoC system. As explained in
more detail below, OSHA determined that SDoC's protection is reactive,
and, therefore, is less likely than the NRTL Program to find
nonconforming products before the products reach the market. In
addition, an SDoC system does not provide assurance that manufacturers
are appropriately certifying products because it lacks an assessment of
the manufacturers' competence, independence, and production control.
1. SDoC as a Reactive System
A substantial problem with SDoC is that it appears to allow
nonconforming products to reach the market. While OSHA designed the
NRTL Program to detect product noncompliance before products reach the
market, the SDoC system is reactive in that its principal means of
protection, post-market surveillance, relies on authorities to verify
the adequacy of testing only after products reach the market, or worse,
after an incident that causes injury or death. In addition, such
product verification is done for only for a limited number of products
by surveillance authorities. As a result, post-market surveillance
provides a lower degree of assurance that products, in general, are
conforming and safe.
Several studies noted in the 2008 RFI highlighted problems with
``portable luminaires'' (i.e., portable lamps) and extension cords in
the European market. (Exhibits OSHA-2008-0032-0011; OSHA-2008-0032-
0012.) The SDoC system in the EU allowed these products to reach the EU
market. The Low Voltage Directive Administrative Cooperation (LVD
AdCo), an ``independent Working Group run and chaired by the Member
States'' conducted the studies, with the Working Group described as ``a
forum for co-operation and exchange of information between national
market surveillance authorities.'' (Exhibit OSHA-2008-0032-0011.) In
2006, LVD AdCo organized its first cross-border market-surveillance
project, a multi-country cooperative and coordinated
[[Page 79043]]
effort involving surveillance authorities from 15 Member States.
The first of these studies targeted portable luminaires in part
because these products ``are relatively cheap to purchase,'' thus
making this project feasible for ``member states with small [market-
surveillance] budgets.'' (Id., p.6.) These products also had a large
number of problem notifications as shown in a chart depicting past
``safeguard clauses and RAPEX notifications.'' (Id.) The study results
show that manufacturers were placing noncompliant products on the
market. The study evaluated a total of 226 luminaires for conformance
to applicable administrative and technical requirements. (Id., p.4.) Of
this total, 38% originated in the EU, 23% originated from China, 10%
originated from other countries outside of the EU, and 29% had no
country of origin specified. (Id., p.15.) The study found that 72%
(162) of the luminaires failed one or more of the technical
requirements, nearly half (74) of which contained ``serious'' technical
hazards, and 23% (53) of which had administrative nonconformities
(missing ``CE'' marks, missing or incorrect technical files, missing or
incorrect declarations of conformity, and similar problems). (Id., p.
17.) According to the report of the study, the results obtained ``do
not give a dependable estimate of the percentages [of] non-compliant
luminaires on the market.'' (Id., p. 18.) However, the report indicates
that the results of the project are consistent with the experiences of
several EU Member States. (Id., p. 19.) A summary of the report states:
Many companies appear to neglect assuring conformity with the
administrative requirements in the Directive. Declarations of
conformity and technical files were often not available or did not
fit the luminaires themselves. The LVD prescribes module A for
conformity assessment, which amounts to self-certification by the
manufacturer or importer into the EU. The choice for module A was
made because of the relatively minor hazards associated with
electrical products. However, the new and global approach is based
on the assumption that the actors comply with the conformity
assessment procedures before CE-marking the product in order to
assure safe products on the markets. For fragmented markets like the
one for luminaires, this assumption does not appear to be valid, if
the results of this and previous national actions are indeed
indicative.
(Id., p. 19.) The report lacks any analysis of the underlying causes
for the high rate of nonconformities found.
The second study addressed extension cords. A press release
provided a summary of the study's results. (Exhibit OSHA-2008-0032-
0012.) The press release indicated that 20 EU Member States
participated in the study and tested 210 extension-cord sets. The
results of the study showed that only one in six extension-cord sets
fully complied with the LVD and the General Product Safety Directive
(GPSD) requirements. (The GPSD specifies requirements for general
consumer products used in the EU.) Although the noncompliant samples
included products that exhibited only administrative failures, the
authorities considered approximately 58% of the extension-cord sets to
be sufficiently unsafe to justify a sales ban or product recall.
Both the luminaire and extension-cord studies show the difficulties
that arise when moving to a system which depends so heavily on post-
market surveillance for enforcement. When unscrupulous or incompetent
manufacturers do not ensure that products meet the applicable safety
standard, the first line of protection for workers does not occur until
after the product reaches the market. In contrast, a third-party
certification system is structured to find and correct such errors
before manufacturers place the products on the market. In response to
the discussion of these studies in the 2008 RFI, several commenters
reiterated that the luminaire and extension-cord studies were not
representative of typical rates of noncompliance for electrical
products on the European market because the studies did not select
luminaires and extension cords randomly for evaluation. (See, e.g.,
Exhibits OSHA-2008-0032-0044.1; OSHA-2008-0032-0051; OSHA-2008-0032-
0053.1; OSHA-2008-0032-0054.1; OSHA-2008-0032-0060.1; OSHA-2008-0032-
0076.1.) Rather, the studies targeted luminaires and extension cords
for evaluation because, in part, these products had high levels of
noncompliance with SDoC requirements. (Id.) Whether these studies are
broadly representative of SDoC noncompliance rates misses the point--
which is that the data on luminaires and extension cords raise serious
concerns for OSHA about the safety of the EU's SDoC system. These
studies make clear that SDoC allowed significant numbers of
nonconforming products to reach the market. Although the EC alleges
that no incidents occurred because of these defective products, the
studies concluded that nearly half of the luminaires tested had
``serious'' technical hazards, and 58% of the extension-cord sets
tested were sufficiently unsafe to justify a sales ban or product
recall. (Exhibits OSHA-2008-0032-0011, p. 17; OSHA-2008-0032-0012.) The
EC also attempted to minimize the importance of these studies by noting
that the studies addressed products that were inexpensive and involved
low-level technology. (Exhibit OSHA-2008-0032-44.1.) This rationale
seems to be a concession that manufacturers engaged in producing such
items are less likely to ensure product conformity under an SDoC. OSHA
cannot ignore the risks posed by these products when evaluating a
conformity-assessment scheme. These data raise serious questions about
whether an SDoC system would assure a high degree of protection for
U.S. workers. We note that commenters presented no studies
demonstrating that the rates of nonconforming products in the EU are
low.
OSHA also reviewed a document prepared by EC staff (Exhibit OSHA-
2008-0032-0013) which provided details about the EU's market-
surveillance system, and served as the basis for associated legislation
that the EU was considering. This document covers a wide range of
issues in a number of areas in which the EU's system needs improvement.
Under ``What are the Problems to Tackle,'' the report states,
``Experience with the implementation of [European] Community
legislation in the area of free movement of goods has highlighted
certain weaknesses and shown that the effectiveness of the system can
still be improved.'' (Exhibit OSHA-2008-0032-0013, p. 12.) The document
states further:
It is generally noted that the enforcement of EU product
legislation is unsatisfactory and a considerable number of non-
compliant (and potentially dangerous) products reach the market. The
share of non-compliant products can only be estimated and the
situation differs very much from sector to sector and from Member
State to Member State.
(Id., p. 19.) This statement partially corroborates the findings in the
report on luminaires, which indicated that the high level of
nonconformities results from difficulties Member States have enforcing
the LVD. In this regard, the staff document notes, ``Currently, market
surveillance does not operate effectively throughout the [European]
Community. * * *'' (Id., p. 20.) The document continues, ``In practice
market surveillance authorities often experience difficulties in
identifying the person who has actually manufactured and/or supplied
the products * * *.'' (Id., p. 23.) This EC document highlights the
reliance of its SDoC system on post-market surveillance, and
underscores
[[Page 79044]]
the risks to workers that would result without an adequate enforcement
scheme.
In its proposal, the EC suggested that reliance on product
liability laws would provide some assurance that an SDoC system
functioned properly. However, none of the commenters demonstrated that
such laws would contribute significantly to ensuring that an SDoC would
provide a high degree of worker protection for electrical safety in the
workplace. As noted by one commenter, liability laws would not be an
effective deterrent against foreign manufacturers, and any remedy
``depends on the injured or damaged party(ies) having knowledge,
resources, evidence, time, and desire to initiate and follow through
with legal action * * *.'' (See OSHA-2008-0032-0072.1.) As noted in the
comment, any injuries would occur before invoking the laws, which would
not provide a high degree of worker protection.
2. Competence and Independence of Testing Organizations, and Production
Control by Manufacturers
Under the EU's SDoC system, the parties performing product testing
do not have to demonstrate, either initially or continually, competence
in determining whether a tested product complies with the applicable
standard. Without assurance of competence, OSHA questions the degree to
which that testing will be performed appropriately. Similarly, a
manufacturer performing product certification has a financial interest
in the profitability of the product, which provides an incentive for
self-dealing when a manufacturer self-certifies its products. Although
OSHA recognizes that many manufacturers would test products
appropriately, it is concerned that allowing SDoC would increase the
probability that at least some manufacturers would test products
poorly, which would cause unsafe products to enter the workplace. In
addition, the EU's SDoC system has no requirement for monitoring
product design changes and for retesting products periodically to
ensure continued safety. More importantly, no comparable requirement
exists to perform multiple annual inspections at critical points of
control (i.e., every factory making a certified product) to ensure that
the products conform to the testing requirements.
Underwriters Laboratories (UL), an NRTL and standards-developing
organization, submitted data to illustrate some of these issues. UL
stated that ``in a sampling of more than 25,000 investigations [of
equipment installed in the field without third-party certification]
carried out by UL, 63% of products reviewed had safety deficiencies.''
(Exhibit OSHA-2008-0032-0072.1.) In addition, UL reported for eight
industries the percentage of products that failed to comply with the
applicable standard when UL tested the products initially: 31% for
appliances, 24% for components, 24% for insulating materials, 14% for
fire protection equipment, 24% for industrial equipment, 16% for
information technology equipment, 45% for lighting, 39% for power
distribution equipment, and 34% for wires and cables. (Id.) UL cites
these statistics as the basis for its estimate that ``at least 20% of
the products submitted to [UL] on a global basis would likely have been
placed on the market with non-conformances if UL had not reviewed
them.'' (Id.) Although UL did not explain the methodology it used to
obtain these results, the data illustrate the risk to electrical safety
that could result when products are not tested appropriately.
The American Council of Independent Laboratories (ACIL) also
submitted similar data. (Exhibit OSHA-2008-0032-0037.1.) ACIL is a
national trade association representing ``independent scientific
laboratory, testing, consulting, product certifying, and R&D firms;
manufacturers' laboratories; and consultants and suppliers to the
industry.'' (Id.) ACIL responded to OSHA's concerns, expressed in the
2008 RFI, that ACIL did not explain the methodology behind the data it
submitted in response to the 2005 RFI. (Exhibit OSHA-2008-0032-0037.1.)
In its comment for the 2008 RFI, ACIL explained that it presented data
indicating a high level of nonconformance among initial product
submissions made by manufacturers to its member laboratories. (Id.)
ACIL also explained that these data came from a survey of its member
laboratories. (Id.) To clarify its earlier submission, ACIL presented,
in response to the 2008 RFI, updated data from a recent survey in which
six of its member laboratories participated. (Exhibit OSHA-2008-0032-
0037.2.) In conclusion, the ACIL and UL data raise the question of
whether manufacturers are qualified to determine whether products
conform to the applicable product-safety test standards.
The EC took issue with the implication that ACIL's initial
submission data demonstrate that an NRTL system provides a higher level
of safety than an SDoC system:
We have heard arguments from the NRTLs that argue that, since
substantial percentages of products fail the safety tests they
perform, an SDoC system is likely to lead to substantial percentages
of non-compliance. This rationale is not substantiated. Our reading
is that during product development, manufacturers have prototypes
evaluated in order to see whether they would meet safety standards.
Also under an SDoC system, manufacturers would do such testing and
would correct designs, when they would not pass. Manufacturers that
intend to comply with the legislation will only market products that
have passed such tests.
(Exhibit OSHA-2008-0032-0044.1, p. 6.) The EC does not, however, cite
any data to support its assumption that manufacturers would be just as
likely as NRTLs to detect and correct defects before putting a product
on the market. OSHA believes that such an assumption is less likely to
be appropriate when, as a general rule, the manufacturer may be
unqualified to perform testing, lacks independence, and has financial
incentives that could override the need to identify defects. However,
OSHA recognizes that some manufacturers would take the necessary
actions to test products appropriately.
The comment submitted by Bureau Veritas Consumer Products Services
(BVCPS) further reinforce OSHA's concerns regarding SDoC.\13\ (Exhibit
OSHA-2008-0032-0038.1.) BVCPS asserted, ``It is our experience based on
testing over 5000 products per year in Asia with CE marking and FCC
regulatory requirements that high levels of non compliance exceeding
50% exist.'' (Id., p. 1.)\1/4\ Although this statement is anecdotal,
and not necessarily statistically valid, it nevertheless suggests that
the SDoC system allows significant numbers of nonconforming products to
reach the market. These data raise serious concerns regarding whether
an SDoC system would provide a high degree of worker protection
required by the OSH Act. Whereas, the NRTL Program detects product
noncompliance before products reach the market, the luminaire and
extension cord studies exemplify the main drawback of an SDoC system--
that it detects noncompliant products only after products reach the
market, and, therefore, fails to provide workers with a high degree of
protection. The data in the record submitted by the EC and
[[Page 79045]]
others supporting an OSHA transition to SDoC fail to show that, despite
these large numbers of noncompliant products on the market in the EU,
the EU's reactive SDoC system is as safe as OSHA's proactive NRTL
Program.
---------------------------------------------------------------------------
\13\ BVCPS is a testing laboratory accredited under the IECEE CB
scheme that conducts technical folder reviews to determine CE
compliance of European-based retailers having Asian supply chains.
The IECEE CB scheme provides for health and safety testing through
the IECEE (IEC System for Conformity Testing and Certification of
Electrotechnical Equipment and Components).
\14\ BVCPS recommended modifying the NRTL system rather than
transitioning to an SDoC system. OSHA addresses this recommendation
below.
---------------------------------------------------------------------------
OSHA also received a comment from CSA International, an NRTL and
provider of certification and testing services, which raised further
concerns about the safety of the SDoC system. (Exhibit OSHA-2008-0032-
0049.1.) This comment quoted from the Fourth Report of the Baltic Sea
Network 2008 \15\ (See http://www.hamburg.de/contentblob/749300/data/kooperationsbericht-vierter-2008.pdf):
---------------------------------------------------------------------------
\15\ The Baltic Sea Network is a cooperative effort among market
surveillance authorities in Denmark, Estonia, Finland, Germany,
Latvia, Lithuania, Poland, and Sweden. The Network is co-financed by
the EC.
To date, market surveillance activities within the Baltic Sea
Network have usually been carried out on the basis of the Low
Voltage Directive and/or PPE Directive. The ratio of faulty products
is at a constantly high level for all product groups. About one-
third is without defects and formal faults and about two thirds of
the examined products show more or less serious failures. 5-10% of
the checked products exhibit failures that are so severe that a
serious danger to consumers cannot be ruled out. In the case of
electric equipment this means the possibility of an electric shock
---------------------------------------------------------------------------
or household fire because of the defective electrical outfit.
(Id., p. 2.) The report does not provide source data for these
statistics or an explanation of the underlying methodology. Yet, these
numbers serve as anecdotal evidence of serious safety concerns
associated with the EU SDoC system.
In sum, the record lacks credible evidence sufficiently
demonstrating that SDoC would provide a high degree of worker
protection. Before revising its regulations, OSHA must determine, on
the basis of substantial evidence, that the revised regulations would
provide U.S. workers with a high degree of protection for electrical
safety. Therefore, OSHA concludes that the lack of sufficient evidence
counsels against revising its regulations to implement an SDoC system
for the approval of electrical products used in U.S. workplaces.
C. Proposed Alternatives
A number of commenters proposed that OSHA modify its NRTL Program
instead of transitioning to an SDoC system. (See, e.g., Exhibits OSHA-
2008-0032-0038.1; OSHA-2008-0032-0097.1.) These commenters suggested
that OSHA retain its NRTL Program, but broaden it to recognize
certifications issued by National Certification Bodies (NCBs) under the
IECEE CB scheme. However, these commenters identified the incorrect
scheme: the scheme that involves acceptance of such certifications is
the IECEE Full Certification Scheme (FCS). While OSHA does not directly
accept the certifications of NCBs, and currently has no plan to do so,
it allows NRTLs to use testing reports from these bodies when issued
under the IECEE CB Scheme.\16\
---------------------------------------------------------------------------
\16\ In this regard, OSHA notes that the EU also does not
directly accept NCB certifications; however, at least one Member
State designated the NCB as a notified body. Unlike NRTLs, EU
notified bodies must reside in the country that authorizes them.
---------------------------------------------------------------------------
The ICT industry proposed a parallel NRTL-SDoC system that would
allow manufacturers to use SDoC as an alternative to certifying
products through the NRTL Program. OSHA will not initiate rulemaking to
propose a parallel SDoC system for the same reason it is rejecting the
EC proposal for a stand-alone SDoC system: the evidence in the record
does not demonstrate that an SDoC system would provide a high degree of
protection to U.S. workers.
ITI (Ex. OSHA-2008-0032-0057.1) also submitted a comment proposing
an alternative to the NRTL Program in which manufacturers would have
products tested by an NRTL, or a third-party organization operating
under the IECEE CB Scheme; the manufacturers then would certify the
products through SDoC. This proposal would retain third-party testing,
but eliminate the post-testing NRTL certification requirements.
Importantly, this alternative would exclude: (1) Initial follow-up
inspections of each manufacturing facility to verify that the products
resulting from production runs conform, or will conform, to the
applicable test standard's requirements; and (2) subsequent follow-up
inspections to ensure that the product currently manufactured at the
facility and bearing the NRTL's mark is identical to the product the
NRTL tested and certified. As OSHA explained in the preamble to the
1988 rule establishing the NRTL Program, an NRTL's continued oversight
of products the NRTL certified serves important OSHA goals. (See 53 FR
12107.) A similar suggestion was made by the Technology Association of
America (Exhibit OSHA-2008-0032-0043.1) to allow the testing to be done
by a third-party organization accredited under the International
Laboratory Accreditation Cooperation (ILAC) Scheme. ITI and the other
commenters are suggesting an alternative without the critical
requirement for factory inspections. These commenters did not submit
information to the record showing that this alternative, absent post-
testing inspections of manufacturers' facilities, would provide U.S.
workers with a high degree of protection. Also, before relying on these
schemes, OSHA must first determine that organizations accredited under
these schemes are as effective in testing products as laboratories
granted recognition under the NRTL Program.
Phillips Electronics also suggested that OSHA ``allow manufacturers
to apply for OSHA recognition to conduct specific product testing, but
continue to seek certification from a recognized NRTL.'' (Ex. OSHA-
2008-0032-67.1.) This suggestion would require OSHA to operate a
recognition program for manufacturers, similar to the NRTL Program,
that would ensure that manufacturers are qualified to perform the
testing, and to verify that they do so consistently and appropriately.
OSHA would need to undertake rulemaking to adopt such a program. OSHA
believes that such a program would have to impose stringent
requirements on manufacturers trying to gain accreditation to, in part,
counter their self-interest in the product. However, OSHA is unsure at
this time what these requirements would be or whether they would be
effective. Further, OSHA would have to resolve technical issues, such
as verifying the adequacy of initial product testing and identifying
and testing product changes. Obtaining and maintaining adequate and
trained staff for such a program would be difficult, especially if
numerous manufacturers participated in the program. OSHA could fund the
program by charging manufacturers fees for program-related activities
performed by OSHA, similar to the fees OSHA currently charges NRTLs.
These fees, however, may be larger for manufacturers than NRTL fees,
depending on the extent of OSHA's activities.
Phillips' suggestion has merit because it proposes to retain
factory inspections by NRTLs. It is unclear, however, whether NRTLs
would perform these inspections; NRTLs may be reluctant to do so
because they would not be conducting initial testing of the products
and, thus, have no assurance that the products meet test standards. If
NRTLs do not perform inspections, OSHA would have to perform them to
assure conformance with test standards, thereby adding to OSHA's
staffing and funding burden.
OSHA believes that a manufacturers' accreditation program would not
be favored by SDoC proponents, and, as noted above, such a program
would be
[[Page 79046]]
resource intensive for OSHA to administer. Further, it is unclear
whether OSHA could implement the program in a way that preserves the
high degree of worker protection currently afforded to workers by the
NRTL program. In light of these concerns, OSHA will not undertake
rulemaking to propose such a program.
OSHA notes again that it currently permits NRTLs to accept testing
conducted by non-NRTL testing laboratories, including laboratories
operated by manufacturers, as part of the NRTL certification process.
This testing can provide time and cost savings to manufacturers. (See
Nationally Recognized Testing Laboratories; Clarification of the Types
of Programs and Procedures, 60 FR 12980 (March 9, 1995).) NRTL
acceptance of such testing is voluntary because OSHA's regulations do
not require that NRTLs accept testing from any party. However, for an
NRTL to accept these test data, OSHA must issue an approval for the
NRTL to use one or more ``supplemental programs,'' which are another
segment of the NRTL Program. OSHA recognizes most NRTLs for these
supplemental programs. One of these programs allows NRTLs to accept
testing conducted by a testing laboratory accredited under the IECEE CB
Scheme, while another program allows an NRTL to use other parties to
perform the post-testing inspections of manufacturers' production
facilities provided the NRTL retains responsibility for the
inspections. An NRTL meeting the regulatory requirements for capability
and independence may use these programs provided the NRTL preserves
ultimate responsibility for approving the product and authorizing use
of its NRTL mark. (Id.)
D. Use of SDoC in the U.S.
Several commenters suggested that, because several U.S. agencies
use SDoC for automobiles and personal protective equipment (PPE), OSHA
also should permit SDoC for electrical equipment used in the workplace.
(See, e.g., Exhibits OSHA-2008-0032-0041.1; OSHA-2008-0032-0043.1;
44.1; OSHA-2008-0032-0057.1.) OSHA does not find this argument
persuasive.
As OSHA explained in the 2008 RFI, the authority of the National
Highway Transportation Safety Administration (NHTSA), which regulates
automobile safety, is different from OSHA's authority to regulate the
workplace. For example, the NHTSA's inspection authority appears to
have a broader geographical scope than OSHA's authority. (Compare 29
U.S.C. 657(a)(1) with 49 U.S.C. 30166(c)(3).) In addition, the OSH Act
at 29 U.S.C. 658(a) gives OSHA authority to cite employers for
violations of the Act and its implementing regulations, and to impose
related penalties; however, the National Traffic and Motor Vehicle
Safety Act at 49 U.S.C. 30163(a) allows the Department of Justice to
seek an injunction in U.S. District Court to enjoin the sale of
defective or nonconforming motor vehicles and equipment. OSHA does not
appear to have the authority to enjoin manufacturers from producing
unsafe electrical products, and no commenter provided a legal argument
contrary to this conclusion. Thus, significant statutory differences
exist between OSHA's authority to regulate electrical products in the
workplace and NHTSA's authority to regulate motor vehicles and
equipment under an SDoC system. Congress would need to revise this
authority significantly for OSHA to perform functions similar to the
functions NHTSA performs. Currently, no justification exists for such a
revision.
Additionally, the automobile industry differs from the electrical
products industry in important ways. For example, a small number of
large, well-known manufacturers dominate the automobile industry. The
group remains fairly constant. In contrast, the electrical products
industry consists of a large number of manufacturers that may vary in
size and that operate, for some product types, in a highly fluctuating
market. These manufacturers can be small and based abroad, making
regulatory interventions difficult. In addition, automobiles are
extremely expensive to recall compared to most low-voltage electrical
products. Thus, the incentives for manufacturers are different in the
two sectors: the risks of a product defect are much greater for a
large, well-known manufacturer of expensive automobiles than they are
for a small, relatively anonymous manufacturer of inexpensive
electrical products. Third-party certification is more important for
electrical products than for automobiles because the incentives to
overlook or ignore testing requirements are higher for manufacturers of
electrical products than for automobile manufacturers.
With respect to PPE, visual inspection by the user or compliance
official generally can confirm compliance. In contrast, a typical user
or inspector of electrical equipment is not in a position to inspect
and evaluate the safety of its electrical components. Furthermore, OSHA
recently conducted rulemaking to clarify the standards for PPE in the
workplace (see 74 FR 46350), and none of the commenters suggested that
OSHA require third-party approval of PPE. Therefore, PPE and electrical
products have different characteristics, and these differences support
the need for third-party approval of electrical products.
E. Post-Market Surveillance in NRTL v. SDoC Systems
Several commenters suggested that post-market surveillance is
equally important in an NRTL system as in an SDoC system. (See, e.g.,
Exhibits OSHA-2008-0032-0041.1; OSHA-2008-0032-0044.1; OSHA-2008-0032-
0045.1; OSHA-2008-0032-0051; OSHA-2008-0032-0053.1; OSHA-2008-0032-
0057.1.) For example, the EC argued:
[I]n any market there are ``willing'' also [sic] ``non-willing''
market players. Both the U.S. and the EU are faced with counterfeits
and rogue market players that ignore rules that are in place. This
implies that governments, independent of the conformity assessment
rules they put into place, need to have an infrastructure to detect
non-compliant products and to take effective action against market
players that place non-compliant products on the market so as to
enforce the rules.
(Exhibit OSHA-2008-0032-0041.1, p. 6.) OSHA agrees that counterfeit
products are a potential problem under both SDoC and NRTL systems. This
problem, however, is more difficult to address under an SDoC system
than under the NRTL Program. Under an SDoC system, the burden of
conducting market surveillance to detect counterfeit marks would fall
on a government agency. In contrast, under the NRTL Program, each NRTL
may conduct market surveillance to assure that manufacturers use only
its mark on certified products, i.e., each NRTL is responsible for
ensuring the integrity of its mark.
OSHA believes that market surveillance is an important means that
NRTLs can use to detect counterfeit products. Several NRTLs also
collaborate with the U.S. Customs Service to monitor for counterfeit
products imported into the U.S. Therefore, shifting to an SDoC system
would impose market surveillance obligations on OSHA to monitor for
counterfeit marks, which would require additional funding and staff
resources; however, OSHA may obtain funding for such a program, in
whole or part, by charging fees to manufacturers or exporters.
OSHA raised the issue of authority in the 2008 RFI, stating it
believes that implementation of SDoC may require revisions to its
statutory authority. Revised statutory authority appears to
[[Page 79047]]
be necessary because OSHA lacks the authority to adopt many of the
post-market enforcement measures essential to ensuring electrical
safety under an SDoC system, including product recalls, bans, and
confiscation. Based on OSHA's analysis of the record, no justification
exists for revisions to OSHA's current statutory authority.
F. The Costs of Administering an SDoC System
In the 2008 RFI, OSHA estimated that implementing an SDoC system in
the U.S. could cost the Agency approximately $360 million annually. In
contrast, the current budget associated with operating the NRTL Program
is approximately $1 million per year. Based on this estimate, operating
an effective SDoC program would require OSHA to incur substantial
additional costs. OSHA's current budget for all of its operations is
about $558 million. Thus, based on OSHA's estimate, adopting an SDoC
system would increase OSHA's entire current budget by more than half.
OSHA asked four specific questions in the 2008 RFI regarding costs
associated with administering an SDoC program. (See 73 FR 62337.)
However, the cost information submitted to the record failed to rebut
OSHA's determination in the 2008 RFI that administering an SDoC system
would be significantly more expensive than operating the NRTL Program.
(See Exhibits OSHA-2008-0032-060.1, OSHA-2008-0032-062.1, OSHA-2008-
0032-071, OSHA-2008-0032-092.1.) Extrapolating from data provided by
one commenter (i.e., a cost of $10 million dollars for every 5 million
inhabitants; OSHA-2008-0032-071), an SDoC system in the U.S. could cost
at least $600 million for approximately 300 million inhabitants. None
of the respondents described the methodology used to determine the
resources necessary to operate an SDoC system, including the number of
inspectors required. The record only shows that most EU countries have
fewer than ten inspectors devoted to enforcement of the LVD.
The substantial additional cost associated with an SDoC system
would be problematic for OSHA because Congress may not fund the system
adequately, thereby reducing the level of post-market inspections
required and jeopardizing worker protection. As noted in an EC staff
document, inadequate budgets significantly reduce the level of market
surveillance performed by some EU countries. (Exhibit OSHA-2008-0032-
0013.) Jeopardizing worker protection because of inadequate funding
would violate OSHA's statutory mandate to provide workers with a high
degree of protection.
IV. Effects on Trade
The EC based its request that OSHA move to a SDoC system on its
claim that the NRTL Program is a barrier to trade, and many other
commenters echoed this view. In this section, OSHA provides its
analysis of this issue.
The 2008 RFI contained three questions related to trade. Most
commenters in favor of SDoC maintained that OSHA's requirements are a
trade barrier, and that OSHA should adopt SDoC to facilitate trade.
(See, e.g., Exhibits OSHA-2008-0032-0041.1; OSHA-2008-0032-0044.1;
OSHA-2008-0032-0045; OSHA-2008-0032-0051; OSHA-2008-0032-0057.1; OSHA-
2008-0032-0060.1.) Interestingly, one SDoC proponent stated that SDoC
does not have a trade advantage over third-party approvals because
``most manufacturers rely on third party tests in any case.'' (See
OSHA-2008-0032-0053.1.)
OSHA believes that its NRTL Program is not a barrier to trade
because the third-party certification requirements apply to all covered
products used in the workplace, regardless of the country in which the
products originated. In addition, OSHA's NRTL Program is equally
accessible to both U.S. and foreign-based organizations. In this
regard, several NRTLs currently have headquarters or facilities in
foreign countries. In contrast to the NRTL system, when the EU requires
third-party certification (e.g., for products excluded from the LVD),
it does not permit foreign-based certification bodies to certify
products for the EU market. Therefore, to comply with the EU's third-
party certification requirement, a U.S. certifier must register as an
EU-based Notified Body for acceptance of any of its certifications in
the EU, whether its certifications are for a U.S. manufacturer or a
manufacturer from another country. This requirement contradicts the
EC's claim in its rationale (Exhibit OSHA-2008-0032-0008) that U.S.
certifiers could ``without any barrier offer their services to U.S.
industry to comply with EU rules.''
Although the EC contends that OSHA's method of approval is an
unnecessary obstacle to trade, OSHA never received information from the
EC or any other source adequately explaining how the NRTL requirements
constitute such an obstacle.\17\ Further, based on evidence submitted
in the record, OSHA finds that implementing an SDoC system for
electrical safety would increase the risk that unsafe products will
enter the workplace and harm workers because such a system cannot
control these risks effectively to provide the requisite level of
worker protection. Therefore, OSHA concludes that the NRTL requirements
are reasonably necessary to provide a high degree of worker protection
required by the OSH Act.
---------------------------------------------------------------------------
\17\ Some statements by SDoC proponents (e.g., asserting that
the NRTL Program causes redundant testing, time burdens, and high
costs (see, e.g., OSHA-2008-0032-0057.1)) are incorrect, not
adequately demonstrated, or unfounded. On the contrary, the NRTL
Program contains flexibilities that avoid or reduce duplication,
delays, and costs.
---------------------------------------------------------------------------
Another argument put forth by proponents of SDoC is that the NRTL
Program forces other countries to develop similar programs, which
proponents view as burdensome. OSHA rejects this argument because the
Agency does not attempt to influence other countries in these
decisions. Each country determines the methods it considers appropriate
for its purposes. Countries are free to adopt SDoC when they find it is
appropriate. In making this argument, proponents appear to be saying
that these countries are more confident in a third-party system than in
SDoC. Also unconvincing is the EC's assertion that OSHA must adopt SDoC
because the EU grants U.S. manufacturers access to the EU market
without the need for third-party approval. However, this argument
implies that, if a country adopts a trade measure for its purposes,
then all countries must reciprocate, even if such action is
inappropriate.
V. Concluding Remarks
OSHA requested information on the SDoC system to better understand
and corroborate the statements the EC made when proposing that OSHA
adopt an SDoC system. The record shows that the EU adopted SDoC to
serve its safety and trade needs by harmonizing the different practices
that existed among the Member States prior to joining the EU. As stated
in the EC's rationale, the EU based its decision to adopt the SDoC
system on its ``assessment of the risk to consumers, workers and the
general interest that non-compliant products * * * [reaching] the
market place * * * would pose danger.'' (Exhibit OSHA-2008-0032-008, p.
1.) The EU then concluded that, for these products, the ``risks are at
a level that they can be satisfactorily managed'' by SDoC. (Id.) As the
record shows, the EU failed to provide statistics or numerical analysis
to support this assessment.
[[Page 79048]]
In conclusion, OSHA is not initiating rulemaking to permit the use
of an SDoC as an alternative to OSHA's current NRTL Program for
approving electrical products for use in the workplace. By statute,
OSHA must demonstrate, based on substantial evidence, that its safety
regulations and standards will provide or maintain a high degree of
protection for U.S. workers. The evidence in the record does not meet
the burden required for OSHA to revise its standards to accommodate an
SDoC system for electrical safety in the workplace. OSHA finds that
such a revision would increase the risk that unsafe products will enter
the workplace and harm workers because an SDoC system cannot control
these risks effectively to provide the requisite level of worker
protection. In addition, Congress would need to authorize and fund OSHA
to regulate and enforce product-related activities of manufacturers,
distributors, and retailers. The evidence in the record submitted in
response to the 2008 RFI does not justify an expansion of, or funding
for, OSHA's regulatory and enforcement authority for the purpose of
implementing an SDoC system. However, notwithstanding this decision,
OSHA remains open to discuss concerns regarding the NRTL Program, as
well as means that may be available to mitigate the concerns expressed
by the EC and other pro-SDoC commenters, provided these means are
within the limits of OSHA's authority, funding, and staffing.
VI. Authority and Signature
David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue, NW.,
Washington, DC 20210, directed the preparation of this notice. This
action is taken pursuant to sections 4, 6, and 8 of the Occupational
Safety and Health Act of 1970 (29 U.S.C. 657), Secretary of Labor's
Order No. 5-2007 (72 FR 31159), and 29 CFR Part 1911.
Signed at Washington, DC on December 13, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-31695 Filed 12-16-10; 8:45 am]
BILLING CODE 4510-26-P