Nationally Recognized Testing Laboratories; Supplier's Declaration of Conformity, 62327-62339 [E8-24826]

Agencies

• DEPARTMENT OF LABOR
• Occupational Safety and Health Administration

[Federal Register Volume 73, Number 203 (Monday, October 20, 2008)]
[Notices]
[Pages 62327-62339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24826]



[[Page 62327]]

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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 (OSHA), Labor.

ACTION: Request for information.

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SUMMARY: The Occupational Safety and Health Administration requests 
comment on a proposal submitted to OSHA by the European Commission to 
permit the use of a Supplier's Declaration of Conformity (SDoC) as an 
alternative to the Nationally Recognized Testing Laboratories (NRTLs) 
product-approval process.

DATES: You must submit information or comments by the following dates:
     Hard copy: postmarked or sent by January 20, 2009.
     Electronic transmission or facsimile: sent by January 20, 
2009.

ADDRESSES: You may submit comments by any of the following methods:
    Electronically: You may submit comments electronically at https://
www.regulations.gov, which is the Federal eRulemaking Portal. Follow 
the instructions online for making electronic submissions.
    Fax: If your submissions, including attachments, are no longer than 
10 pages, you may fax them to the OSHA Docket Office at (202) 693-1648.
    Mail, hand delivery, express mail, or messenger or courier service: 
You must submit three copies of your comments to the OSHA Docket 
Office, Docket No. OSHA-2008-0032, U.S. Department of Labor, Room N-
2625, 200 Constitution Avenue, NW., Washington, DC 20210. Deliveries 
(hand, express mail, messenger, and courier service) are accepted 
during the Department of Labor's and Docket Office's normal business 
hours, 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the 
OSHA docket number (i.e. , OSHA-2008-0032). Submissions, including any 
personal information you provide, are placed in the public docket 
without change and may be made available online at https://
www.regulations.gov.
    Docket: To read or download submissions or other material in the 
docket, go to https://www.regulations.gov or the OSHA Docket Office at 
the address above. All documents in the docket are listed in the http:/
/www.regulations.gov index; however, some information (e.g. , 
copyrighted material) is not publicly available to read or download 
through the Web site. All submissions, including copyrighted material, 
are available for inspection and copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT: Press inquiries: Jennifer Ashley, 
Director, OSHA Office of Communications, Room N-3647, U.S. Department 
of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; 
telephone: (202) 693-1999. General and technical information: MaryAnn 
Garrahan, Director, Office of Technical 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. Our Web 
page includes information about the NRTL Program (see https://
www.osha.gov and select ``N'' in the site index).

SUPPLEMENTARY INFORMATION:

I. Introduction

    OSHA requests information and comments on a proposal it received to 
permit the use of a Supplier's Declaration of Conformity (SDoC) as an 
alternative to the Nationally Recognized Testing Laboratories (NRTLs) 
product-approval process. NRTLs are third-party (i.e. , independent) 
laboratories that have met OSHA's requirements for performing safety 
testing and certification of electrical and other products used in the 
workplace. NRTLs test and certify these products to determine whether 
they conform to appropriate U.S. product-safety testing standards. In 
contrast, an SDoC is a written statement, produced by an equipment 
manufacturer or supplier, that a product meets or conforms to a 
specified test standard or a set of requirements. OSHA is aware of the 
concept of manufacturer's self-approval and that it is allowed, for 
certain types of products, in the U.S. (by certain Federal agencies) 
and other countries. Details on this use are covered later in this RFI.
    OSHA is taking this action in response to a request from the 
European Commission (EC) that OSHA allow an SDoC system for certain 
electrical products. SDoC is currently accepted for certain electrical 
products in all European Union (EU) countries. OSHA issued a similar 
Request for Information (RFI) in 2005 in response to a proposal from an 
industry trade association for OSHA to convert to an SDoC system for 
IT-related products. At that time, OSHA considered the responses from 
the 2005 RFI to be insufficient to justify initiating rulemaking for a 
change to an SDoC system. Since then, OSHA has obtained more 
information about SDoC, partially through meetings with the EC, and 
this information and the EC's proposal raise issues and topics that 
were not fully explored in the 2005 RFI. The Agency is currently 
interested in responses specifically related to the issues and topics 
raised in the EC proposal or otherwise described in this present RFI. 
OSHA will examine all responses received from this RFI to determine 
whether to initiate rulemaking or take any other action with respect to 
SDoC. OSHA requests comments from all interested parties on any of the 
issues raised in this RFI, or any other issues the public feels is 
relevant for OSHA to consider, and particularly seeks comments that 
include specific detailed scientific, technical, statistical, or 
similar data and studies, of a credible nature, supporting any claims 
made by commenters. OSHA wants to emphasize the importance of receiving 
such evidentiary information.
    The remainder of this notice is divided into several sections. 
Section II gives background information on OSHA's NRTL system for the 
approval (also known as conformity assessment) \1\ of electrical 
products. It also provides background information on OSHA's first RFI 
on SDoC, and then describes events leading to OSHA's current RFI. It 
also includes background information regarding the World Trade 
Organization (WTO) Agreement on Technical Barriers to Trade. Next, 
section III discusses requirements for OSHA rulemaking, section IV 
summarizes key aspects of the EC's proposal related to SDoC, section V 
discusses information that OSHA has obtained to date on the European 
Union's (EU) SDoC system for the approval of electrical products, and 
section VI describes what OSHA has found to date to be basic elements 
of an SDoC system, discussing certain topics and issues to provide a 
foundation for the questions for which OSHA is seeking specific 
information. Questions for the public's consideration are included in 
the latter three sections.
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    \1\ While OSHA uses the term ``approval'' to describe the type 
of testing or certification activities performed by NRTLs, the 
international community often uses a different term for such 
activities: Conformity assessment. An international guide, ISO Guide 
2, defines ``conformity assessment'' as ``any activity concerned 
with determining directly or indirectly that requirements are 
fulfilled.''

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[[Page 62328]]

II. Background

A. OSHA Approval Requirements and NRTL Program

    Many of OSHA's workplace standards require that certain types of 
equipment be approved by an NRTL. (In this RFI, OSHA refers to these 
provisions as ``NRTL approval requirements.'') Most of the requirements 
for NRTL approval of equipment (also called ``products'' herein) used 
in the workplace are found in the Agency's General Industry standards, 
29 CFR part 1910. For example, 29 CFR 1910.303(a) (read together with 
the definitions of ``approved'' and ``acceptable'' in 29 CFR 1910.399) 
generally requires electric equipment or products used in the workplace 
to be approved by NRTLs. A comprehensive list of NRTL approval 
requirements and the categories of products which must be approved can 
be found on OSHA's Web site at www.osha.gov/dts/otpca/nrtl/.
    Since its inception, OSHA has required that electric and other 
types of equipment be approved by certain qualified organizations as 
one measure for ensuring the safety of this equipment, thereby 
continuing the long history in the U.S. of electric equipment safety-
testing being performed by third-party (i.e. , independent) 
organizations. Adopting these requirements led eventually to the 
establishment of the NRTL Program, which ensures that these 
organizations are qualified to perform the product approvals.
    OSHA's NRTL Program recognition process involves a thorough 
analysis of an NRTL applicant's policies and procedures and a 
comprehensive on-site review of the applicant's testing and 
certification facilities to ensure that the applicant meets the 
requirements of 29 CFR 1910.7. OSHA's staff also conducts annual on-
site audits to ensure that existing NRTLs adequately perform their 
testing and certification activities and maintain the quality of those 
operations.
    OSHA imposes on the NRTLs several requirements found in 29 CFR 
1910.7. Three of the requirements set forth the definition for an 
organization's testing and certification capabilities. The remaining 
requirement mandates an organization's complete independence from any 
manufacturers, vendors, and major users of equipment subject to the 
requirements. This last requirement ensures that organizations within 
the program are third parties.\2\
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    \2\ NRTLs may be based in the U.S. or in other countries. 
Currently, there are 15 NRTLs, of which 13 are established in the 
U.S. and two are foreign-based.
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    NRTLs generally approve products for a manufacturer before the 
products are sold or shipped. The NRTL performs two major functions in 
the product-approval process: Testing and certification. For the first 
function, the NRTL tests a representative unit or prototype of the 
product to ensure that it has appropriate safety features. For this 
purpose, the NRTL may control and accept testing performed by parties 
that the NRTL has qualified. These parties typically include 
independent testing laboratories and even the product's manufacturer. 
The testing ensures that the product conforms to the technical 
requirements specified in test standards. For the second function, the 
NRTL certifies the product, not only by issuing a certificate and 
authorizing use of its certification mark, but more broadly through 
listing and labeling, and follow-up inspection programs. The NRTL may 
use a contractor under the NRTL's control to conduct the inspections. 
Inspections must be done on a regular basis at the product 
manufacturer's factories or assembling facilities to gain assurance 
that all manufactured units of the product are the same as the unit 
initially tested and certified.
    For more information about the program, see the Web site 
(www.osha.gov/dts/otpca/nrtl/), as well as Ex. OSHA-2008-
0032-0004 of this docket and the exhibits under Docket NRTL03-SDOC, the 
latter pertaining to OSHA's first RFI on SDoC.

B. OSHA's First Request for Information on SDoC

    OSHA previously published an RFI on SDoC in response to a proposal 
from an industry trade association, the Information Technology Industry 
Council (ITIC). It recommended a change from the NRTL approval to an 
SDoC system for ensuring the safety of information technology equipment 
used in the workplace. (Ex. 1, Docket NRTL03-SDOC.) The proposal 
claimed that SDoC would reduce products' time-to-market delays and 
would not have a detrimental effect on the safety of affected products. 
It also claimed that information-technology (IT) equipment had a strong 
workplace safety record.
    ITIC further suggested that all IT equipment should be approved to 
meet the technical requirements of the IEC 60950 test standard issued 
by the International Electrotechnical Commission (IEC), a leading 
organization in the development of international test standards. ITIC 
advocated the use of this test standard by all countries. (Ex. 1A, 
Docket NRTL03-SDOC.) OSHA noted that NRTLs already used UL 60950, the 
corresponding U.S. harmonized version of the IEC 60950 standard, for 
approving IT equipment. The IEC 60950 standard (or UL 60950 or other 
harmonized versions) covers not only IT, but also a number of other 
common products (e.g., printers, copiers, and telephones) and 
specialized equipment (e.g., communications terminal equipment and 
mail-sorting machines).
    The proposal also included a study by Industry Canada, an agency of 
the Canadian government, which discussed ways that agencies in various 
countries use SDoCs for approvals of equipment. (Ex. 1B, Docket NRTL03-
SDOC.) The study noted the importance in an SDoC system of having a 
responsible regulatory agency with audit and enforcement authority 
after products are sold. In contrast, under current OSHA regulations, 
NRTLs must perform key functions before products are sold. The study 
identified only EU countries as allowing use of SDoC for regulating the 
safety of electric equipment. The study noted the importance of each 
country's ``market surveillance authority to monitor the products 
placed on the market.'' (Id., page 28.) As also noted, with respect to 
EU's enforcement measures, ``[m]any surveillance authorities may use 
warnings, administrative actions (such as [product] modifications, 
recall, sales ban, confiscation and publication) and, ultimately, 
prosecution (fines and imprisonment).'' (Id., page 29.)
    OSHA determined, however, that ITIC's proposal lacked information 
needed to determine whether to initiate rulemaking. To obtain more 
information and give interested parties an opportunity to comment on 
the ITIC proposal, OSHA issued an RFI on November 15, 2005 (70 FR 
69355). The RFI contained seven questions seeking detailed information 
related to the operation of an SDoC system, and seven questions related 
to specific aspects of the ITIC proposal. Twenty-six comments were 
received in response to the RFI. Commenters in favor (mainly from three 
product industry associations) claimed that SDoC would reduce product 
time-to-market and that SDoC systems have similar safety records to 
OSHA's NRTL Program. Commenters opposed to the proposal (mainly from 
product industry associations, individuals, and NRTLs) claimed that the 
competence of different manufacturers varied widely, and that there 
were no sufficient reasons for OSHA to change its system. These latter 
commenters claimed that safety would suffer under an SDoC system. Some 
commenters also stated that OSHA did

[[Page 62329]]

not have the authority to implement an SDoC system. Industry 
associations opposed to the proposal included the National Electrical 
Manufacturers Association. Many commenters, both for and against the 
proposal, stated that adoption of SDoC would require OSHA, at a 
minimum, to implement a postmarket-surveillance system, which would 
require monitoring products after they reached the market, thereby 
leading to potential enforcement actions such as product bans or 
recalls.
    In general, however, commenters did not provide adequate data to 
support their arguments. For example, parties on both sides of the SDoC 
question offered little in the way of adequate data to support their 
positions. With regard to the safety risk of the products, the data or 
other information were not presented in a manner to ensure validity or 
to allow for analysis and evaluation. In this regard, the American 
Council of Independent Laboratories (ACIL) reported results from a 
survey it conducted, stating that ``50% of IT and Office Equipment 
products were non-compliant after first submittal to the NRTL,'' and 
that 50% of these noncompliances were ``major safety and health 
related.'' (Ex. 2-5, Docket NRTL03-SDOC.) However, ACIL offered no 
report summarizing all the results of the survey or information about 
the methodology of the survey, the response rate, or the data upon 
which respondents relied. Likewise, Underwriters Laboratories (UL) 
provided no details about how it determined that ``[a]pproximately 50% 
of the IT equipment'' submitted to it ``initially fails to meet the 
applicable safety requirements.'' (Ex. 2-4-1, Id.) Similarly 
unsupported were UL's statements that ``[f]ield sampling in the 
European Union suggests that up to 50% of the IT equipment on the 
market in the European Union today does not comply with applicable 
requirements'' and that ``[i]n 2004, electric appliances accounted for 
27 percent of RAPEX-posted products and were determined to present a 
serious risk to consumers' health and safety.'' (Ex. 2-4-1, Id.) (RAPEX 
is formally called the Community Rapid Information System.) The 
Canadian Standards Association referenced a German study which 
purported to show that ``certified ('tested') products appeared much 
less often in accident and fault reports than uncertified products,'' 
but did not provide the study for OSHA's review or a citation where it 
might be found. (Ex. 2-7-1, Id.)
    Similar problems exist with the data submitted by the proponents of 
SDoC. ITIC calculated a defect rate of 0.2 percent for ``US computer 
products'' between 1994 and 1999, but did not provide the original 
sources of the data from which this figure was calculated. (Ex. 1, id.) 
It is also unclear why more recent data were not used. In any event, 
their approach did not account for a significant confounding factor--
that all computer equipment operating from an electric outlet and used 
in U.S. workplaces is required to be NRTL approved--so ITIC's method 
did nothing to measure the safety of equipment sold or used only under 
an SDoC system.
    Other data submitted by ITIC address this problem, in part. A graph 
in a PowerPoint presentation prepared by UNICE (now known as 
``BUSINESSEUROPE''), and submitted by ITIC, shows that in 2004, 27% of 
RAPEX notifications of unsafe products were for products manufactured 
in the EU, compared with 2% for U.S.-manufactured products. (Ex. 2-9-1, 
Id.) Again, the underlying data are not provided. However, taken at 
face value, these statistics suggest that an NRTL system may reduce the 
risk of unsafe products. No firm conclusions may be drawn, however, 
without more information, such as the percentages and types of U.S.-
manufactured goods and EU-manufactured goods sold in the EU. Another 
UNICE graph showed a relative decrease in electrocutions in Germany 
compared to the U.S. between 1960 and 1989. (Ex. 2-9-1, Id.) However, 
the 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.
    In summary, much of the information submitted by commenters lacked 
the supporting data and details requested in the RFI. In addition, as 
the above examples demonstrate, some comments provided inadequate 
support for data, figures, or claims, or provided little or inadequate 
explanation. OSHA analyzed all of the comments and concluded that the 
information did not justify a decision to initiate rulemaking to adopt 
SDoC. Most importantly, OSHA found that the information it received did 
not provide reasonable assurance that adopting SDoC would provide a 
high degree of protection for the safety of products used in the 
workplace. Without such assurance, OSHA found little justification to 
initiate a rulemaking. Furthermore, OSHA believed that implementation 
of SDoC might require a change to OSHA's legislative authority in 
addition to an increase of appropriations. The change in legislative 
authorization appeared necessary because OSHA lacked authority to adopt 
many of the enforcement measures for electrical safety noted earlier 
for the SDoC system implemented by the EU, including product recalls, 
bans, and confiscation, among other measures. The Agency could not 
justify such requests from Congress based on the information obtained 
through the RFI process.
    In view of these findings, which summarize only some of the key 
areas of concern, OSHA decided to take no further action on the 
proposal and announced its decision in the Spring 2007 Semi-Annual 
Regulatory Agenda, published on April 30, 2007 (see 72 FR 22870).

C. Events Leading to Second Request for Information 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 Agreement'' or ``Agreement''). (Ex. 
OSHA-2008-0032-0002.) This is a trade-related agreement that has a 
number of objectives, foremost of which is ``removing barriers to 
transatlantic commerce'' (see section II of the Agreement). The 
Agreement's Annex 1 lists a number of activities affecting different 
U.S. and EU agencies and sectors, including ``initiating an exchange on 
conformity-assessment procedures for the safety of electrical 
equipment.''
    The agreement established a Transatlantic Economic Council (TEC) to 
monitor progress toward meeting the goals of the Framework Agreement. 
As stated in the Agreement, 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.'' Through the TEC, in 
July 2007, the EC issued a brief statement proposing that OSHA adopt 
SDoC for all electric equipment, claiming that this action would 
``reduce unnecessary costs for transatlantic trade.'' (Ex. OSHA-2008-
0032-0003.) Working in part through the TEC, OSHA and the EC arranged a 
meeting to undertake the Annex 1 activity regarding the exchange of 
information on the conformity-assessment procedures for the safety of 
electrical equipment.
    On October 11, 2007, representatives of OSHA and two other offices 
within the Department of Labor met with representatives of the EC to 
conduct an

[[Page 62330]]

exchange of information in furtherance of the Annex 1 activity. A 
summary of this meeting was produced that captures key aspects of these 
systems. (Ex. OSHA-2008-0032-0004.) The participants considered the 
meeting to be productive, but neither side was able to ask all of its 
questions due to lack of time.
    At its first formal meeting, held 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.'' (Ex. OSHA-2008-0032-0009.) In March 2008, the EC issued 
another statement requesting the ``[U.S.] Government to allow the 
import and sale of any low-risk electrical and electronic product on 
the basis'' of SDoC.\3\ (Ex. OSHA-2008-0032-0005.) At the second formal 
TEC meeting, held on May 13, 2008, Secretary of Labor Elaine Chao 
stated that OSHA would issue a second RFI on SDoC. (Ex. OSHA-2008-0032-
0006.) Among other things, this RFI allows OSHA to obtain a better 
understanding regarding SDoC and, as noted earlier, certain related 
topics and issues not fully explored in the 2005 RFI. In June 2008, at 
the request of OSHA, the EC submitted a formal rationale for its 
request that OSHA adopt SDoC for ``electrical and electronic 
products.'' This rationale is discussed in section IV.
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    \3\ OSHA does not regulate the ``import and sale'' of products, 
but its rules do affect whether certain products may be used in the 
workplace, thus affecting whether those products may be sold or 
imported into the U.S.
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D. World Trade Organization's Agreement on Technical Barriers to Trade

    The U.S. and 152 other countries are Members of the World Trade 
Organization (WTO) and party to the Agreement Establishing the World 
Trade Organization which includes the Agreement on Technical Barriers 
to Trade (TBT Agreement) (see Ex. OSHA-2008-0032-0007). The TBT 
Agreement addresses technical regulations, standards and conformity 
assessment procedures for products or related processes and production 
methods. In terms of the TBT Agreement, OSHA's NRTL approval 
requirements are considered conformity-assessment procedures. The TBT 
Agreement states Members' desire to ensure that technical regulations, 
standards, and conformity assessment procedures do not create 
unnecessary obstacles to trade while recognizing that no Member should 
be prevented from taking measures that are necessary inter alia to 
protect human health or safety. Article 5 of the TBT Agreement requires 
Members to ensure that its central-level conformity assessment 
procedures are not prepared, adopted or applied with a view to or with 
the effect of creating unnecessary obstacles to international trade and 
explains that ``this means inter alia that conformity assessment 
procedures shall not be more strict or be applied more strictly than is 
necessary to give the importing Member adequate confidence that 
products conform with the applicable technical regulations or 
standards, taking into account the risk non-conformity would create.''
    Congress amended the Trade Agreements Act of 1979, as amended 
(``TAA''; 19 U.S.C. 2501 et seq.) to implement the TBT Agreement. In 
particular, the TAA indicates that Federal agencies may not ``engage in 
any standards-related activity that creates unnecessary barriers of 
trade.'' 19 U.S.C. 2532. A standard is ``necessary'' in this context:

    [I]f the demonstrable purpose of the standards-related activity 
is to achieve a legitimate domestic objective including, but not 
limited to, the protection of legitimate health or safety, essential 
security, environmental, or consumer interests and if such activity 
does not operate to exclude imported products which fully meet the 
objectives of such activity.

    19 U.S.C. 2531(b).
    The TAA also requires Federal agencies to take international 
standards into account in standards-related activities, and to base 
their standards on the international standards ``if appropriate.'' 19 
U.S.C. 2532(2)(A). However, international standards are not 
``appropriate'' if they do not adequately protect ``human health or 
safety, animal or plant life or health or the environment.'' 19 U.S.C. 
2532(2)(B). Likewise, the TAA provides that it may not be construed 
``to limit the authority of a Federal agency to determine the level it 
considers appropriate of safety or of protection of human, animal, or 
plant life or health, the environment, or consumers.'' 19 U.S.C. 
2531(a)(2).
    OSHA's NRTL Program and its third-party approval requirements apply 
to certain equipment or products used in the workplace, regardless of 
whether they are manufactured within or outside of the U.S. In 
addition, the NRTL Program is open to both U.S. and foreign-based 
organizations, which gives them equal opportunity to become an NRTL. 
OSHA's requirements for approval of electric equipment are necessary 
measures for protecting employees against electrical shock, 
electrocution, burns, and fires, and, thus, to protect the safety of 
the employees. The NRTL Program is necessary to provide assurance that 
the approvals are performed by qualified organizations. As discussed 
later in this notice, the EC views OSHA's third-party approval 
requirements and NRTL Program as unnecessary obstacles to trade. (See, 
for example, Ex. OSHA-2008-0032-0005.) Although OSHA disagrees with 
this view, it issues this RFI to gather information bearing on the 
question that an SDoC system, at least for some categories of 
equipment, may protect employees sufficiently to satisfy the 
requirements of the OSH Act.

III. Requirements for OSHA Rulemaking

    The primary purpose of the Occupational Safety and Health Act is to 
assure, so far as possible, safe and healthful working conditions for 
every American employee. 29 U.S.C. 651(b). To fulfill this purpose, 
Congress gave the Secretary of Labor the authority to promulgate, 
modify, or revoke mandatory occupational safety and health standards. 
29 U.S.C. 655.\4\
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    \4\ In its comments submitted in response to the previous RFI, 
ITIC argued that OSHA could adopt an SDoC system through an 
interpretative rule without notice and comment. (Ex. 4-19, pp. 10-
12, Docket NRTL03-SDOC.) OSHA disagrees with this assertion. Current 
rules require NRTLs to be ``completely independent of * * * 
manufacturers or vendors of equipment or materials being tested. * * 
*'' 29 CFR 1910.7(b)(3). A change to this requirement would 
constitute a legislative rule that ``directly governs the conduct of 
[employers], affecting individual rights and obligations,'' Long 
Island Care at Home, Ltd. v. Coke, 511 U.S. --, 127 S. Ct. 2339, 
2350 (2007) (internal quotation marks omitted). To guarantee that 
employers have an opportunity to participate in the formulation of 
these individual rights and obligations, OSHA must follow the 
notice, comment, and hearing procedures of the Administrative 
Procedure Act and the OSH Act.
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    The Act, the case law developed under it, and OSHA regulations 
establish a number of requirements that the Agency must meet before 
exercising this authority. Some of these requirements are procedural. 
For example, the Agency must support its findings with substantial 
evidence in the record developed through the rulemaking proceedings, 
and explain the basis for accepting or rejecting all major suggestions 
for modification of a proposed standard. See ``Supplemental Statement 
of Reasons'' for the final rule on Control of Hazardous Energy Sources, 
58 FR 16612 at 16615; see also 29 U.S.C. 655(b)(2), (b)(3), and (f). In 
addition, when OSHA decides to change a standard, it must provide a 
reasoned basis for the change. International Union, UAW v. OSHA, 37 
F.3d 665, 668-69 (DC Cir. 1994) (``Lockout/Tagout II'')

[[Page 62331]]

    OSHA also is constrained by substantive rulemaking requirements. 
Accordingly, the OSH Act requires that safety standards, like the NRTL 
approval requirements, must ``afford a high degree of protection'' to 
employees. Lockout/Tagout II, 37 F.3d at 669. Thus, for OSHA to adopt 
an SDoC approval standard and related program, it must find, on the 
basis of substantial evidence, that the SDoC system provides this high 
degree of protection to employees who use equipment that would be 
covered by the standard. In this regard, OSHA has been careful to 
ensure that changes to its product-conformity program maintain existing 
levels of employee safety. See the final rule on Safety Testing or 
Certification of Certain Workplace Equipment and Materials, 53 FR 12102 
at 12103, April 12, 1988.

IV. EC's formal proposal for OSHA to adopt SDoC

A. Overview of rationale

    The EC's proposal to OSHA concerning the adoption of SDoC is 
captured in its March 2008 statement (Ex. OSHA-2008-0032-0005) and 
supplemented by its June 2008 rationale (Ex. OSHA-2008-0032-0008).\5\ 
The March 2008 statement formally requests that OSHA ``review its 
conformity assessment procedures in the area of electrical and 
electronic products.'' In this statement, the EC also advocated SDoC 
because it believes third-party conformity assessment of ``low-risk 
electrical and electronic product[s]'' 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 ``low-risk electrical and 
electronic product[s],'' 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 EC, therefore, maintains that such products present a level 
of risk that would make SDoC an inappropriate means of conformity 
assessment, and the EC requires the use of third-party approvals in 
such cases.
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    \5\ In August 2008, OSHA received a complementary proposal, 
jointly submitted by three industry associations, that provides a 
suggested approach for implementing an OSHA SDoC system. See section 
VI.G if you wish to comment on this approach.
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    In its rationale, the EC noted that it has long experience with 
``conformity assessment regimes'' that do not require manufacturers to 
obtain third-party certification. The EC stated that it made ``an 
assessment of the risk to consumers, workers, and the general 
interest'' as to whether certain ``non-compliant products [reaching] 
the market would pose a danger.'' The EC then concluded that for these 
products ``these risks are at a level that they can be satisfactorily 
managed'' by requiring manufacturers to demonstrate compliance and 
retain proof of compliance for inspection by public authorities. It 
also stated that such rules, along with legal liabilities on 
manufacturers, consumer-protection legislation, and appropriate 
enforcement measures would guarantee a high level of safety for 
European consumers. The EC further stated that it instituted its 
approach in the area of electrical safety through its ``Low Voltage 
Directive,'' for products rated ``between 50-1000 volts AC and 75-2500 
[sic] volts DC. * * *'' (Note: the actual DC upper limit is 1500 
volts.) We will provide some general information about EC directives in 
the next section of this notice.
    The EC contends in its rationale that OSHA's third-party 
requirements cause an ``imbalance in market access * * * [by 
manufacturers for] transatlantic trade in electrical products,'' and an 
``imbalance in market access for the [EU] certification industry'' 
because they are subject to OSHA's NRTL approval requirement while U.S. 
certifiers are not subject to any such comparable EU requirement. The 
EC also asserts that the requirements increase the likelihood that 
countries importing products from the U.S. and the EU will establish 
their own form of testing and approval. The EC further contends that an 
OSHA change to SDoC ``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 US.'' It attributes this effect in part to 
``the high level of safety of electrical and electronic devices.'' 
Moreover, it 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 [of accidents].'' 
Finally the EC claims that ``market mechanisms [in the EU] 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.''
    The EC's rationale also suggests several topics to cover in this 
RFI, and OSHA is including the questions in section VI, below, to 
address these topics.

B. OSHA Comments on EC's Rationale

    The key part of the EC's rationale is its conclusion that the 
safety risk associated with noncompliant electrical products can be 
satisfactorily managed through SDoC. Indeed, this is a threshold 
determination that OSHA must make before it proposes an SDoC approval 
standard or related program. As discussed below, however, to date the 
EC has failed to support this conclusion with the evidence necessary 
for OSHA to reasonably ensure that SDoC would satisfy the standard-
setting requirements of the OSH Act. Such support could include, for 
example, an explanatory study or report that adequately describes, 
quantifies, or otherwise specifies the level or characteristics of 
noncompliance, or the characteristics of the electrical or other safety 
risk involved. It is clear that the EC would not permit SDoC for 
particular equipment if it believes that the safety risk of 
noncompliance is too high. In fact, it justifies the use of SDoC for 
low-voltage products on the grounds that the safety risk of 
noncompliance is low. (Ex. OSHA-2008-0032-0008, p. 1.) However, it is 
unclear from the EC's proposal whether the EU determined that the 
safety risk from noncompliance was low before it implemented the SDoC 
for low-voltage products, or determined that the low level of risk 
resulted through implementation of SDoC. Also, it was unclear from the 
proposal how the EU made this determination. In addition, the EU 
believes that this low level of noncompliance and the resulting low 
level of safety risk is maintained because manufacturers are required 
to retain ``proof'' of compliance and because manufacturers are subject 
to legal ``liability, consumer protection legislation and an 
appropriate enforcement.'' (Id.) The EC has not provided evidence to 
support this conclusion regarding the effectiveness of an SDoC system, 
and a reliable means of tracking the results of such a system would 
help to provide the required evidence. OSHA would need to review this 
evidence before it could reach similar conclusions.
    The EC further contends that European consumers and employees 
``experience an equally high, if not higher level of electrical safety 
as their counterparts in the U.S.'' (Ex. OSHA-2008-0032-0008, p. 2.) 
The EC attributes this ``higher level'' in part to ``the high level of 
safety of electrical and electronic devices.'' (Id.) The EC also claims 
that ``[s]tatistics furthermore

[[Page 62332]]

demonstrate'' that accidents involving equipment are not attributable 
to ``a relationship between non-compliance and incidents [of 
accidents].'' (Id.) It later notes that ``most electrical and 
electronic products and especially high technology products * * * have 
an excellent record of compliance.'' (Id.) To date, OSHA has received 
no data to support any of these statements. OSHA would need to receive 
such information to determine whether to initiate rulemaking on SDoC.

C. Questions

    As noted above, the EC identified a number of issues in its 
rationale and suggested that the RFI include questions addressing a 
number of topics. OSHA's comments above also serve as a basis for other 
questions.
Questions Related to Details and Data Supporting EC's Rationale
    IV.1. What information and evidence is available to support the 
conclusion that the risk of nonconforming products posing a danger was, 
is, and will be low under SDoC? If possible, describe, quantify, and 
otherwise specify the level or characteristics of noncompliance, and 
the characteristics of the electrical or other safety risk involved.
    IV.2. What data, documentation, or records exist to demonstrate 
adequately that European consumers and employees experience a level of 
electrical safety at least as high as their counterparts in the U.S.?
    IV.3. What legal liability, consumer-protection legislation, and 
enforcement programs exist in the EU to ensure that its SDoC system has 
maintained and will maintain the risk of danger posed by noncompliant 
products at a low level, or to ensure that the level of noncompliant 
products will be low? Are there similar protections in the U.S.?
    IV.4. What data or documentation exists to demonstrate adequately 
that accidents in the EU involving electric equipment are not 
attributable to product noncompliance, and that most electrical and 
electronic products, especially high-technology products, have an 
excellent record of compliance?

V. The EU's SDoC System

A. Background

    On June 25, 2008, the EC submitted a formal proposal to OSHA to 
issue a second RFI on the adoption of an SDoC system for certain ranges 
of products. (Ex. OSHA-2008-0032-0008.) The proposal states that the 
RFI would further the TEC's goals of ``promoting transatlantic trade 
and regulatory convergence.'' It states that obligatory third-party 
certification of certain products, such as is required by OSHA, can 
create barriers to trade, and that programs that create such barriers 
should be justified by the additional benefits they confer. In 
addition, the proposal points out that the U.S. has implemented SDoC 
systems for many product categories other than electrical products. The 
proposal claims that the EC's system is as effective as the U.S.'s for 
protecting both consumer and employee safety.
    The proposal requests that the RFI obtain information for an 
assessment of the elements that would be necessary to implement an SDoC 
system, and to obtain data and information about what classes of 
products such a system would most appropriately regulate. At the time 
of publication of this RFI, the EU's SDoC system is the only one of 
which OSHA is aware that exists for the conformity assessment of 
electrical-product safety. In this section, we review the information 
we have obtained on this system as a basis for later questions seeking 
a better understanding of this system.

B. The EU's SDoC system

    The summary of the October 11, 2007, information-exchange meeting 
between OSHA and EC representatives (Ex. OSHA-2008-0032-0003) provides 
much of the information included in this part. Research by OSHA staff 
also provided information.
    Products covered by the EC's SDoC system for electrical safety are 
determined by the Low Voltage Directive (LVD) (Ex. OSHA-2008-0032-
0017), which was implemented in 1973 to promote the free movement of 
goods across the EU. (The LVD does not apply to goods intended for 
export to countries outside the EU.) Such directives constitute laws 
enacted by the European Council and European Parliament. These laws are 
generally proposed by the EC. More information on these institutions 
and their functions is available at https://europa.eu/index_en.htm . 
The LVD covers all equipment between 50 and 1000 volts AC and 75 and 
1500 volts DC, except as specifically excluded in its Annex II. 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 electric equipment of the 
telecommunication industry and electric-power industries, respectively. 
The EC's proposal asserts that all products covered under the LVD have 
been demonstrated to be ``low-risk,'' and that electrocutions have 
become rare in the EU since the LVD was implemented, which the EC 
argues indicates 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 lowest-risk products and formally called ``internal 
production control,'' is the only system for which SDoC is permitted on 
its own, i.e., without other and stronger regulatory controls. (See Ex. 
OSHA-2008-0032-0015 for an illustration of the safety requirements for 
products covered by each module.)
    Enforcement under the LVD is conducted through Member States' 
postmarket surveillance. The EU countries must enact their own national 
laws to implement the LVD, and assign at least one agency (called the 
``surveillance authority'') to enforce these laws. In the United 
Kingdom, for example, this role is filled by approximately 250 local 
government agencies, whereas in other countries, one agency or one part 
of an agency may fill this role. The surveillance authority's 
inspections are a critical aspect of its activities. Among the 
countries, the kinds and number of inspections vary depending on the 
number of available inspectors, the amount of available funding, and 
the type and number of problems the EU country is facing. In at least 
one country, inspections are based primarily on complaints and 
accidents, and in other countries, inspections are based primarily on a 
random selection of products. Once a potential deficiency is found, the 
manufacturer, if known, may be required to submit to the authority a 
report by an independent testing organization (called a ``notified 
body'' in the EU) demonstrating that the product conforms to the 
applicable test standard. For those products that do not conform, the 
manufacturer must make a risk assessment and propose corrective 
actions. Ultimately, the country's surveillance authority makes a final 
decision on risk, which, as noted in the next section, can vary 
substantially across countries. The authority then decides what 
remedial action to take, which may include 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 placing the

[[Page 62333]]

product in that country's market) responsible, and impose the remedial 
action on that party.
    For products posing immediate safety risks, and affecting more than 
one country, the EU has a rapid alert system (RAPEX). This system is 
increasingly used for communicating information about noncompliant 
products. Another notification system, the Information and 
Communication System for Market Surveillance (ICSMS), also has this 
purpose, but it is not used by all Member States. Technical files of 
products covered under the directive must be maintained by the 
manufacturer for at least 10 years after the products go on the market. 
Private-sector bodies called ``European Standardisation Organisations'' 
are responsible for developing and maintaining the technical safety 
specifications for the products, similar to the role of the American 
National Standards Institute in the U.S. In addition, a product that 
complies with the harmonized EU versions of international test 
standards is assumed to be in compliance with the LVD. If challenged by 
the Member States' surveillance authority, a manufacturer must prove it 
has complied with the LVD either by demonstrating compliance with 
harmonized test standards or by other means. In cases for which the 
manufacturer cannot be found, the burden passes to the importer, who 
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.
    While EU Member States cannot add safety-related requirements to 
the LVD, they can regulate nonsafety-related public-interest 
requirements. The LVD, like other directives, is binding upon Member 
States, which are supposed to implement it by transposing it into their 
own national laws. If the Member States do not implement or do not 
properly implement the LVD or other product-related directives through 
their own legislation, they are nonetheless obligated to accept 
products declared compliant with the LVD unless the products are found 
to be noncompliant. Fines imposed on manufacturers or importers for 
noncompliance with the LVD are levied by individual Member States, and 
may vary between different Member States.

C. Effectiveness of the EU's SDoC system

    The EC has stated that its SDoC system has provided European 
consumers and employees with a high level of safety. It argues that 
this level is the same or higher than that achieved by the U.S. under 
its NRTL system. However, the EC did not provide data, in its 
submissions, to demonstrate its position in a way that would support 
rulemaking by OSHA. As noted by the EC in its presentation at the 
October 11, 2007, meeting with OSHA, the lack of harmonization in the 
EU of methods to collect statistics on electrical accidents hinders any 
comparison of statistics between the U.S. and the EU, or even among 
Member States within the EU.
    OSHA has obtained information that highlights different aspects of 
the EU's SDoC system, and provides a gauge of its effectiveness. We are 
summarizing this information solely to provide a basis for some of our 
questions in this RFI, and not to draw conclusions from it.
    First, we present the reports of the results of two projects that 
were undertaken by EU market-surveillance authorities, then discuss a 
relevant report issued by the staff of an office of the EC, and finally 
describe some aspects of the EU's RAPEX and ICSMS systems.
    The Low Voltage Directive Administrative Co-operation (LVD AdCo) is 
``an independent Working Group run and chaired by the Member States. 
The Group is a forum for co-operation and exchange of information 
between national market surveillance authorities.'' (Ex. OSHA-2008-
0032-0010.) In 2006, LVD AdCo organized its first cross-border market-
surveillance project, i.e. , a multi-country cooperative and 
coordinated effort, by the surveillance authorities from 15 Member 
States. In deciding which products to target, the project report notes 
that consideration was given to the differences in ``infrastructures 
and funding * * * between member states,'' and the need to ensure 
``that cost was minimized and that the technical requirements for the 
tests were within the possibilities of all potential participants.'' 
(Ex. OSHA-2008-0032-0011, p. 5.) This approach highlights the technical 
and financial limitations faced by some Member States in performing 
their surveillance functions.
    The study targeted ``portable luminaries'' (i.e. , portable lamps) 
partly because they ``are relatively cheap to purchase,'' thus making 
this project feasible for ``member states with small [market-
surveillance] budgets.'' These products were selected for study because 
of the large number of problem notifications found with these products 
by Member States, as shown in a chart depicting past ``safeguard 
clauses and RAPEX notifications.'' (Ex. OSHA-2008-0032-0011, p. 6.) For 
the project, a total of 226 luminaires were evaluated for conformance 
to applicable administrative and technical requirements. 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. The project found that 72% (162) of the 226 
luminaires failed one or more of the technical requirements, with 
nearly half (74) containing ``serious'' technical hazards, and 23% (53) 
of the 226 luminaires had administrative nonconformities (missing 
``CE'' marks, missing or incorrect technical files, missing or 
incorrect declarations of conformity, and other similar problems). 
(Id., p. 17.) According to the report of the project, sampling was not 
random. Consequently, 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 match the actual experiences of several EU Member 
States. A summary of the report states the following:

    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. It recognizes some difficulties in 
market surveillance caused by differences between the systems of EU 
Member States, noting:

    Differences exist between the member states in the grading of 
shortcomings: the same violation of a specific requirement leads to 
different assessment of the resulting risk and as a consequence to 
different interventions. Given the differences in legal systems[,] 
differences in sanctions imposed in the various member states for 
similar violations cannot be avoided.

    The report states further that ``multinational companies operating 
in the European union * * * will rightly wonder why it is that the same 
violation is considered a serious risk in one

[[Page 62334]]

member state, while another member state classifies it as a minor 
risk.'' The report suggests that in this area ``harmonization is 
urgently needed.'' (Id., p. 23.)
    A similar project was conducted on extension cords, and a summary 
of the results was provided in a press release. (Ex. OSHA-2008-0032-
0012.) The press release indicated that 20 EU Member States 
participated in the study, and 210 extension cords were tested. The 
results show that only one in six cord-extension 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 also 
included those products that exhibited only administrative failures, 
approximately 58% of the cord-extension sets tested were considered 
sufficiently unsafe by the authorities to justify a sales ban or 
product recall.
    OSHA also reviewed a document prepared by the EC's staff (Ex. 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 where the EU's system needed 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.'' (Ex. OSHA-2008-0032-0013, p. 12.) The document 
also declares that, ``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 faced by Member 
States in enforcing the LVD. Further, the staff document notes, 
``Currently, market surveillance does not operate effectively 
throughout the Community. * * *'' (Id., p. 20.) The document notes 
later, ``In practice market surveillance authorities often experience 
difficulties in identifying the person who has actually manufactured 
and/or supplied the products * * *'' (Id., p. 23.) OSHA is aware that 
the legislation pertaining to this staff document was passed and is due 
to go into effect in 2010, although OSHA has not obtained the details 
of the measures adopted to address the problems and recommendations in 
the staff document.
    The staff document states that the number of noncompliant products 
in the EU is unknown and the reporting systems in the EU lack 
uniformity. The EU's RAPEX and ICSMS are notification systems used by 
market-surveillance authorities for enforcement purposes. Formally 
called the Community Rapid Information System, RAPEX is used for a 
number of ``non-food consumer products.'' It is not typically used for 
products that are mainly for industrial or commercial purposes. It also 
is not used for notification of noncompliant products when ``the 
effects do not or cannot go beyond the territory of a Member State. * * 
*'' (Ex. OSHA-2008-0032-0021, p. 7.) As a result, Member States may 
judge a number of actions to be outside the scope of RAPEX and, thus, 
not report them. Therefore, RAPEX results may not give an accurate 
estimate of problems associated with certain products. For example, the 
2006 annual report for one Member State authority showed that it had 
3,770 queries and complaints related to electrical goods. (Ex. OSHA-
2008-0032-0022, p. 29.) The report further states that about 200 
investigations were carried out relating to products that may pose a 
safety risk. (Id., page 20.) The number of RAPEX notifications for that 
country in 2006 was 14. (Ex., OSHA-2008-0032-0023, p. 15.)
    The following questions seek further information and data regarding 
these studies, as well as information and data pertaining to the 
effectiveness of the EC's SDoC system.
    V.1. The luminaire and cord-extension projects identified 
substantial noncompliance with the LVD and, if the results are 
representative of the wider array of products for which an SDoC is 
acceptable, appear to be inconsistent with the EC's claim regarding the 
safety of products evaluated under their SDoC system. Is this a valid 
inference from these studies? Do the data and study methods have 
limitations that would affect this inference?
    V.2. What data and/or record systems exist in each Member State to 
track the effectiveness of their SDoC system?
    V.3. Are other reports and documents available that evaluate 
whether the SDoC system implemented by each Member State is effective 
or ineffective in safeguarding product safety? What are the strengths 
and weaknesses of the RAPEX, ICSMS, or other data or reporting system 
used in the EU?

VI. Topics and Issues for Consideration in a Possible Rulemaking

    As part of this RFI, OSHA is seeking information on the topics and 
associated issues described below (with the questions for each topic 
noted parenthetically):
    A. Product safety in an SDoC system (VI.1 to VI.5).
    B. Product risk and specifications (VI.6 to VI.15).
    C. Administration of an SDoC system (VI.16 to VI.26).
    D. Costs of an SDoC system (VI.27 to VI.30).
    E. Enforcement of an SDoC system (VI.31 to VI.34).
    F. Effects on trade (VI.35 to VI.37).
    G. Implementation suggestions by certain industries (VI.38).
    In responding to the questions in this section, please explain the 
reasons supporting your views, and identify and provide the relevant 
information on which you rely, including data, studies, articles, and 
other materials.

A. Product Safety in an SDoC System

    A major purpose of this RFI is to determine whether SDoC approval 
of certain electrical products would provide employees with a high 
level of protection (see section III above). OSHA's current NRTL 
Program meets this standard. NRTLs must first evaluate and test a 
sample, and then perform follow-up inspections of manufacturing 
facilities to ensure that they continue to make products that are safe 
to use. These inspections are critical, and to obtain an adequate level 
of assurance, NRTLs may, if warranted, inspect 100% of all products in 
a production batch for this purpose. OSHA has a number of policies that 
specify controls that NRTLs must have in place to properly accomplish 
pre-market evaluation. OSHA then audits each NRTL to ensure that they 
have instituted these controls and that the controls are working 
properly. NRTLs deficient in these areas must make corrections or face 
revocation of their recognition. These measures provide the necessary 
assurance that OSHA's current system provides a high level of 
protection to employees.
    One measure of the effectiveness of OSHA's current system is 
recalls issued by the Consumer Product Safety Commission (CPSC). The 
OSHA NRTL Program staff reviews these recalls, and for those involving 
products that have been certified by an NRTL, the staff has not 
identified a recall that was due to improper testing by an NRTL. In

[[Page 62335]]

addition, the staff knows of no other data showing that such testing 
caused product-related injuries to employees.
    OSHA sought information on SDoC effectiveness during its first RFI 
on SDoC, but did not receive data or a rationale that demonstrated the 
effectiveness of SDoC in assuring product safety. Most of the 
respondents to the specific questions suggested instead that product 
safety under SDoC needs to be assured through a proper postmarket 
surveillance system, including marketplace and factory testing, and 
accreditation of laboratories engaged in the testing, even if they are 
affiliated with the manufacturer. Also, in its rationale, the EC points 
to reliance on liability laws and other protection laws for assuring an 
effective SDoC.
    OSHA now requests information or data clearly demonstrating that 
product approval of electric equipment through SDoC is currently a 
highly protective approach, as well as a description of the measures 
currently in place or other measures that would need to be adopted to 
ensure that an SDoC system for electrical products will be highly 
protective to employees.
    Postmarket surveillance would be a new activity for OSHA. Adequate 
administrative and enforcement resources and procedures in this area, 
based on the information obtained to date, would need to be extensive, 
and are critical in assuring product safety under an SDoC system. Such 
a system appears to include its infrastructure, along with appropriate 
rules for assuring SDoC effectiveness, and penalties for breaking those 
rules.
    As indicated by the summary of the EU's SDoC system in section V, 
postmarket surveillance would require that OSHA have the legal 
authority to: establish rules requiring manufacturers and other parties 
to take certain actions related to issuing SDoCs; take enforcement 
actions such as product recalls, bans, quarantines, and confiscations; 
and assess financial and criminal penalties on product manufacturers, 
importers, or their representatives, and, perhaps, on wholesalers and 
retailers for selling nonconforming or dangerous products. OSHA's 
authority extends to the U.S. workplace and, thus, its authority 
regarding SDoC would presumably apply only to products actually used or 
intended to be used in the U.S. workplace. Further, OSHA does not have 
explicit authority to issue product recalls and bans, or to quarantine 
or confiscate nonconforming products, or to assess the sort of criminal 
and financial penalties described above. We further discuss the issue 
of authority, below, in part E.
    The following questions address issues raised in this part.
    VI.1. In determining whether to undertake rulemaking for SDoC, what 
specific measures and practices should OSHA consider adopting or 
requiring to provide assurance that product approvals through SDoC will 
be highly protective to employees? What are the major elements or 
components needed to assure SDoC effectiveness?
    VI.2. Should OSHA rely upon other measures outside its own 
authority to ensure that product approvals through SDoC will be 
effective? For example, how should U.S. product-liability laws and 
consumer-protection programs, as suggested by the EC, be considered in 
evaluating a conformity-assessment scheme?
    VI.3. In determining whether to adopt SDoC, what systems should 
OSHA consider establishing or using to track the effectiveness of SDoC?
    VI.4. S