[Federal Register: October 20, 2008 (Volume 73, Number 203)]
[Notices]
[Page 62327-62339]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc08-103]
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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 http://
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 http://
www.regulations.gov.
Docket: To read or download submissions or other material in the
docket, go to http://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 http://
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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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/index.html.
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/index.html), 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 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 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")
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 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 http://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
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 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
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. Should the U.S. consider entering into agreements with other
countries to permit them to enforce SDoC requirements for products
originating outside of the U.S.? What should be the minimum
requirements under such agreements?
VI.5. What safety objectives and technical requirements should be
met by manufacturers and others parties having obligations under an
SDoC system? What tests or risk assessments should be conducted by
manufacturers or other involved parties?
B. Product Risk and Specifications
The EC has requested that OSHA allow SDoC for certain electrical
products, but did not specify the type of equipment or the criteria for
defining this equipment. As noted earlier, the EC's system allows SDoC
for products rated up to 1000 volts AC (1500 volts DC). In its
rationale, the EC suggests that equipment should be eligible for SDoC
if it has a low risk of noncompliance with the applicable test standard
and thus poses a low risk of danger. (Ex. OSHA-2008-0032-0008, p. 1.)
However, the EC provides no explanation for this concept, which raises
questions about its exact meaning. It is unclear whether this equipment
was determined to have a low risk of noncompliance because low risk was
demonstrated by: historical data (including the reasons for
noncompliance); technical factors inherent in the equipment or inherent
in the test standard; the manufacturers performing the testing (i.e. ,
would they, regardless of their qualifications or actions, manufacture
low-risk products); or other factors or analyses. Knowing exactly how
the EC made its determination that equipment rated up to 1000 volts AC
(1500 volts DC) has a low risk of noncompliance and resulting low
safety risk would be helpful to OSHA, as would an explanation as to why
equipment must have such low risk to be eligible for approval through
SDoC. As explained earlier in section III, OSHA must ensure that
equipment is a low-risk hazard to employees. Therefore, the method of
conformity assessment must ensure that the hazard associated with
equipment is low risk.
OSHA seeks information on the factors that define low risk of
noncompliance and on methodologies that could be used to determine
whether a category of electric equipment is likely to have such a low
risk. We seek information on whether such an analysis has been done, or
how one could be done. In this context, a noncompliant product is one
that fails to meet the safety-critical elements of a test standard and,
thus, would necessarily pose a danger to an employee. Noncompliance
with nonsafety-critical elements is not at issue.
Certain industry organizations have argued that SDoC should be
limited to products that have "demonstrated an excellent safety
record" that support their qualification as low risk "in the
workplace." (Ex. OSHA-2008-0032-0019.) Although this assertion has
been made for information technology products, OSHA has yet to receive
the historical data supporting and/or adequately demonstrating the
assertion that the safety records of any type of products justify SDoC.
Also, it is unclear whether this safety record is due to low risk of
nonconformity or an inherently low risk of danger in the equipment. If
this claim is based upon historical data of electrical products used in
the U.S., then it could be attributable to a number of factors,
foremost of which could be the prevalence of third-party testing in the
U.S. OSHA requests data that clearly demonstrate the safety record of
this equipment, whether favorable or not, as well as information that
adequately identifies the underlying reasons for this claim.
OSHA also seeks information on whether certain types of electric
equipment have an inherently low risk of posing danger. In the first
RFI, OSHA asked whether SDoC should be limited to "low voltage (for
example, 50 volts or less) IT equipment. * * *" (70 FR 69359, November
15, 2005.) No comments were received addressing this concept, which we
again raise here. Specifically, we seek information on whether certain products have
features that would inherently limit the risk of hazard to an employee,
which may be the result of the requirements of the product-safety test
standards used to evaluate the product. OSHA is aware that some
standards limit the available voltage, current, and power (under normal
and abnormal operating conditions) in some electrical products, thereby
lowering risk to employees and others who may have access to this
equipment. In these cases, OSHA seeks information on whether such
products would present a low risk of hazard under the worst-case
conditions of noncompliance, and thus, whether an SDoC may be an
adequate tool for ensuring the safety for such products.
In addition, OSHA seeks information on the possibility of
incorporating aspects of other U.S. agencies' SDoC-type systems into
any system that OSHA may eventually adopt. Conformity assessment
systems administered by the Federal Communications Commission (FCC)
include tiered levels of conformity assessment. The FCC determines the
conformity assessment procedure required based on the complexity of
testing or the telecommunication system or radio-frequency interference
risks associated with a nonconforming product. Such tiered systems
recognize that different levels of conformity assessment are necessary
for different products or standards based on the type of risks posed by
noncompliance. Depending on the product or standard for which
conformity is being assessed, the FCC may require evaluation and
testing by an accredited third-party testing laboratory or by the FCC,
or may permit SDoC. The CPSC is another U.S. agency that makes use of a
conformity assessment system similar to SDoC. CPSC has used SDoC-type
systems for most products under its jurisdiction. In August 2008,
Congress approved the Consumer Product Safety Improvement Act (CPSIA);
it mandates, among other things, that manufacturers of any children's
products certify that their products under CPSC's jurisdiction meet
federal requirements for consumer-product safety based on testing by an
accredited independent third party. If certain conditions are met, the
Act allows the CPSC to permit such testing to be conducted by the
manufacturer's "firewalled" \6\ laboratory. (Ex. OSHA-2008-0032-
0018.) The following questions pertain to the issues discussed in this
part.
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\6\ According to the CPSIA, a firewalled laboratory is one that
is owned, managed, or controlled by a manufacturer or private
labeler but which may be accredited as a third party testing
laboratory if the Commission makes certain findings that the
laboratory is protected from undue influence by the manufacturer or
private labeler. In addition, certain measures must be in place to
report to the Commission of any attempts by this party to hide or
exert undue influence over test results.
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VI.6. What data demonstrate that products sold in the EU (i.e. ,
operating at 1000V AC or 1500V DC or less) have a low risk of
nonconformance with applicable standards? How is conformance being
determined by the EC, and what requirements or criteria are used to
judge conformance?
VI.7. What data demonstrate that products operating at these
voltages, current, and power levels present low-risk electrical and
fire hazards?
VI.8. In making a determination about rulemaking, how should OSHA
determine which products to include under a possible SDoC system?
Should OSHA consider a product's risk of harm or injury and the
potential severity of harm or injury, as well as its risk of
nonconformance with applicable standards? Should OSHA consider
production processes (as the EU suggests in their proposal)? What
methodology and factors should OSHA consider in determining risk, and
what level of risk should OSHA consider acceptable? What mechanism
should OSHA consider in evaluating this risk on a continuing basis?
VI.9. In considering whether to adopt SDoC, should OSHA consider
only voltage for defining low risk of nonconformance, a low risk of
hazard or injury, both of these factors, or other electrical variables?
VI.10. When considering voltage, current, and power as parameters
for defining products which present a low risk of nonconformance and a
low risk of injury or harm, should OSHA use limits published in
product-specific standards (meaning that different products may have
different limits), or should a single set of limits be established for
all products? If a single set of limits should be established, what
value should the limits be and what data are available to support the
assertion that these limits would not present a risk of injury or harm
to employees?
VI.11. What other types of data related to product risk should OSHA
review when considering whether or not to adopt SDoC, and are these
data readily available?
VI.12. Should OSHA use the type of manufacturer or industry, or a
standard industry classification, in defining the appropriate
parameters for products that would be eligible for SDoC?
VI.13. What justification exists for establishing a single class of
electrical products for inclusion in an SDoC system? What properties do
such electrical products have that distinguish them from other products
such as ladders and fire doors that require third-party product
certification?
VI.14. Should global test standards be used as a basis for
determining conformity assessment of products (with safeguards to
adjust for specific U.S. conditions) and, if so, how does this approach
differ from current conformity assessment practices in the U.S.?
VI.15. Are there any aspects of other U.S. agencies' SDoC systems
(e.g., CPSC's "firewalling" authority to designate a manufacturer's
lab as a third-party laboratory) that may be useful for OSHA to adopt
in an SDoC system for the safety of electrical products used in the
workplace? Are there differences between OSHA and these agencies that
may impede or prevent adopting aspects of their SDoC system or creating
a similar system?
C. Administration of an SDoC system
Information that OSHA has received from the EC and the U.S.
government, industry associations, and other concerned parties
indicates that an effective SDoC program requires an extensive level of
government oversight of product manufacturers, importers, and
distributors, and that these entities may number in the thousands.
Oversight may include postmarket-surveillance activities, product
recall authority, penalty assessment, a complaint-handling system, and
testing and inspection of products after they are in the market. A
government oversight program may also require developing and overseeing
a premarket registration system for manufacturers and importers, and
distributors. The EU's experience shows a successful postmarket-
surveillance program must have sufficient resources in terms of number
of inspectors, expertise in the wide variety of products to be
regulated, and the ability to perform the tests necessary to ensure
conformity. (See Ex. 1-B, pp. 20-25; Ex. OSHA-2008-0032-0011, pp. 5 and
7.) OSHA's existing budget, staff, and facilities are not adequate for
such an effort.
OSHA's current NRTL Program does not include postmarket
surveillance, product-recall authority, penalty assessment, postmarket
testing and inspection of products, or premarket registration of
products. OSHA's oversight of the program consists of recognition and
audits of NRTLs, of which there are a limited number (currently 15),
and investigation of complaints. OSHA relies on the NRTLs to exert controls over
manufacturers through private-sector mechanisms such as conducting
factory inspections and postmarket surveillance. NRTLs conduct
premarket testing or rely on other parties (including certain product
manufacturers) to conduct this testing if the NRTL determines they are
qualified. Thus, OSHA believes it would need to adopt fundamental
changes to existing requirements under an SDoC system. In considering
an SDoC system, OSHA seeks comment on the following questions that
address how to administer such a system.
VI.16. What administrative systems are required to effectively run
an SDoC system? How much do they cost? How would these systems interact
with OSHA's existing operations? Could OSHA expect to recoup any of the
costs of running an SDoC program?
VI.17. In determining whether to undertake rulemaking for SDoC,
should OSHA consider accrediting third-party organizations to conduct
postmarket testing or surveillance, and, if so, how? What elements of
OSHA's current NRTL Program could be used to implement the
accreditation process? Should current NRTLs be automatically eligible
for conducting postmarket testing and surveillance under an SDoC
system?
VI.18. Should OSHA consider requiring manufacturers and importers
to register their products in a central database that identifies
supplier-approved products? Should OSHA require manufacturers to obtain
registration numbers, and require products to bear these registration
numbers so that OSHA or its agents can monitor supplier-certified
equipment? Should OSHA assess fees to pay for this monitoring?
VI.19. What advantages or disadvantages are there to requiring
manufacturers to establish an office in the U.S. or requiring the party
executing the SDoC to be located in the U.S?
VI.20. Should OSHA consider adopting SDoC as an alternative to its
current third-party approval requirements, as a replacement for these
requirements, or as an extension of the requirements? How can the two
programs be integrated or perform complementary roles?
VI.21. What responsibilities should importers or employers have to
ensure that the products they import have been properly approved under
an SDoC system?
VI.22. What responsibilities should employers have to ensure that
the SDoC-approved products they use have complete and accurate
documentation supporting conformance, and that the product supplier has
appropriately registered with OSHA or an organization identified by
OSHA?
VI.23. What records or reports should OSHA require from
manufacturers, importers, and distributors to ensure conformance with
SDoC? Where should these records and reports be maintained? What access
would OSHA need to product and production information, including
foreign-produced equipment? Should OSHA consider assessing penalties
for providing inaccurate or incomplete information?
VI.24. What percentage of manufacturers would continue to use
third-party certification systems like the NRTL Program even if they
were eligible to use SDoC?
VI.25. For manufacturers that use third-party testing for their
SDoC, should OSHA recognize the results of tests performed by any
accredited testing laboratory regardless of location without requiring
explicit recognition by OSHA? If so, how can OSHA ensure that such
laboratories are qualified to perform the testing? What regulatory
measures should OSHA consider to encourage the use of accredited tests
under an SDoC system?
VI.26. What obligations should manufacturers and others have to
ensure that noncompliant products can be traced (e.g., through marking
and labeling)?
D. Costs of an SDoC System
OSHA seeks information on the costs to manufacturers associated
with administering the SDoC system discussed in this RFI, as well as
the cost of OSHA's NRTL Program and the EU's SDoC system. The EC raised
the issue of cost in its July 2007 statement (see Ex. OSHA-2008-0032-
0003) by claiming that OSHA's NRTL system costs EU exporters 1.3
billion Euros annually. The EC, however, did not provide the basis for
this estimate. OSHA does not know the exact resources that would be
required to effectively operate an SDoC system. The following
discussion illustrates the possible costs of implementing such a
system. OSHA has obtained information showing that the cost of
postmarket surveillance for one relatively small EU country is 2
million Euros, which is $3 million at an exchange rate of about $1.50
per Euro. (Ex. OSHA-2008-0032-0014.) Extrapolating from this figure to
the 50 U.S. states provides a rough draft estimate of approximately
$180 million for implementing an SDoC system in the U.S. An estimate of
the market-surveillance costs for a larger EU country is 13 million
Euros or about $20 million (Ex. OSHA-2008-0032-0016). Extrapolating
this figure to the 50 U.S. states for an additional rough draft
estimate, implementing SDoC could cost approximately $360 million.\7\
As noted above, these estimates are simply illustrative of possible
costs, and OSHA is using this extrapolation to approximate the
resources needed to implement an SDoC system. The level of these
resources would depend on a number of factors, such as the number of
manufacturers, importers, or other parties that OSHA would need to
regulate; the number and type of products that might enter the
workplace; and the sampling techniques and other measures that OSHA
would include in an enforcement strategy. OSHA also seeks information
on who should pay these costs, i.e., taxpayers or, similar to the NRTL
system, manufacturers, importers, or distributors through fees charged
for the service.
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\7\ The small EU country is Finland, which has a population of
approximately 5 million. Using the $3 million postmarket
surveillance cost results in a cost of $0.60 per person. The U.S.
population is 300 million, and multiplying this figure by $0.60 per
person results in a total cost of $180 million. The Netherlands,
which is the larger EU country, has a population of approximately
16.5 million, resulting in a $1.20 cost per person. Thus, the
estimate of the cost in the U.S., based on the per-person cost in
the Netherlands, would be $360 million.
---------------------------------------------------------------------------
The NRTL Program currently has an annual operating budget of
approximately $1 million, and a portion of which may be reimbursed to
the government by the NRTLs. The cost to manufacturers using NRTLs
consists of fees charged for initial testing of the product sample, and
then fees paid to the NRTLs to cover factory inspection costs and
certification-mark licensing. It is difficult to derive an accurate
estimate of the total costs to manufacturers from total NRTL revenues
because NRTLs often perform other non-NRTL work. Therefore, OSHA seeks
adequate and reliable information on the total cost of its NRTL system
to manufacturers.
As noted in one of the EC project reports described in section V of
this notice, inadequate budgets are a factor driving the level of
surveillance performed by some EU countries under their SDoC system. As
also noted, the EU has determined that the surveillance and enforcement
components of systems in at least some Member States are
unsatisfactory. Consequently, current figures from some EU countries
may not reflect the true cost of administering an effective SDoC
system. OSHA is interested in obtaining adequate and reliable
information on these costs for those EU countries that have a well-founded
and effective postmarket surveillance system. The following
questions solicit information on this issue.
VI.27. Are there any available data that show the annual cost to EU
Member States of administering their SDoC systems (e.g., number of
products inspected, number of inspectors, cost of inspections, costs of
inspectors' labor)? If possible, provide any available costs aggregated
for the EU as a whole.
VI.28. Who should pay the operating costs, and what means should
OSHA use to pay these costs? For example, what are the potential
advantages and disadvantages of using appropriations, registration fees
assessed to manufacturers, fines assessed against nonconforming
products, or other methods to pay these costs?
VI.29. When comparing SDoC and third-party certification (in
particular, OSHA's NRTL Program), are initial product-approval costs
lower for one system than for the other system? If so, how much money
is saved using the less expensive system?
VI.30. When comparing SDoC and third-party certification (in
particular OSHA's NRTL Program), are ongoing product-approval costs
lower for one system than for the other system? If so, how much money
is saved using the less expensive system?
E. Enforcement of an SDoC System
SDoC systems raise a number of issues concerning enforcement
schemes required by the OSH Act, including the authority the OSH Act
grants to OSHA inspectors. The OSH Act currently allows inspectors the
right to inspect "any factory, plant, establishment, construction
site, or other area, workplace or environment where work is
performed." See 29 U.S.C. 657(a)(1). By way of contrast, the National
Highway Transportation Safety Administration (NHTSA), which operates a
manufacturer-certification program for motor vehicles, has authority to
inspect motor vehicles wherever they are held for sale in interstate
commerce, as well as locations where motor vehicle accidents occur. 49
U.S.C. 30166(c)(3). Thus, the NHTSA's inspection authority appears to
have a broader geographical scope than OSHA's authority.
The OSH Act's enforcement scheme differs from that typically found
in SDoC regimes. Under the Act, OSHA inspectors are authorized to: cite
employers for violations of the OSH Act, including its associated
standards and regulations; propose an assessment of a civil monetary
penalty; and require abatement of the violation within a reasonable
time. 29 U.S.C. 658(a). If the employer challenges the citation,
abatement is not required until the Occupational Safety and Health
Review Commission issues a final order on the citation. 29 U.S.C.
659(b). However, OSHA may apply to a U.S. District Court for an order
requiring an employer to correct an "imminent danger" pending the
enforcement action. 29 U.S.C. 662(a).
Compared to the scope of enforcement action granted to OSHA under
the OSH Act, a wider range of enforcement tools is usually available
under an SDoC system or to other U.S. government agencies. For example,
the EU's General Product Safety Directive allows the responsible
national authority (acting in concert with other Member State
authorities and with the EC) to issue product bans, withdrawals, and
recalls for "dangerous products" that pose a "serious risk." See
Directive 2001/95/EC of 3 December 2001 on General Product Safety, art.
8 & 11, 2002 O.J. (L11) 10-12; Ex. OSHA-2008-0032-0020, pp. 10-11. The
EU also has established the RAPEX and ICSMS systems that advise the
public of product-safety risks and nonconformities. (Ex. OSHA-2008-
0032-0004, p. 11.) The NHTSA has authority to require automobile
manufacturers to notify motor-vehicle purchasers and dealers of defects
and nonconformity with motor-vehicle safety standards, and require
motor-vehicle manufacturers to remedy defects or noncompliance. 49
U.S.C. 30118. The National Traffic and Motor Vehicle Safety (NTMVS) Act
also allows the Department of Justice (DOJ) to seek an injunction in
U.S. District Court to enjoin the sale of defective or nonconforming
motor vehicles and equipment. 49 U.S.C. 30163(a). The FCC allows a
manufacturer to use, for certain products, a declaration of conformity
to assure compliance with its electromagnetic-compatibility
requirements, and the Federal Communication Act gives the DOJ the
authority to seize equipment made, possessed, or sold with the intent
to violate the FCC's regulations. 47 U.S.C. 510.
If manufacturers are allowed to take a major role in guaranteeing
the safety of their products through an SDoC system, sufficient
criminal penalties for substantial violations may be necessary to
sustain public confidence in this system. In this regard, a Canadian
case study notes that the SDoC systems it analyzed usually had criminal
penalties, though these penalties were rarely applied. (Ex. 1-B, p. 9,
Docket NRTL03-SDOC.) The OSH Act makes it a crime punishable by a
$10,000 fine and six-months imprisonment, on the first offense, for an
"employer who willfully violates" an OSHA standard when the violation
causes an employee's death. 29 U.S.C. 666(e). The OSH Act imposes the
same penalties against "[w]hoever knowingly makes any false statement,
representation, or certification" in documents required to be
maintained by the OSH Act. 29 U.S.C. 666(g). By contrast, the NTMVS Act
imposes up to 15 years imprisonment for making misrepresentations with
the intent to mislead the Secretary of Transportation when complying
with certain reporting requirements related to motor-vehicle safety
defects that have caused death or serious bodily injury. 49 U.S.C.
30170(a).
OSHA is seeking public comment on the following questions
concerning enforcement issues.
VI.31. Would OSHA's current authority grant inspectors performing
SDoC postmarket surveillance sufficient geographic scope to conduct the
necessary inspections, or are there other areas to which inspectors
might need access that are not covered by this authority? Would OSHA
inspectors need explicit statutory authority to impound or remove
product samples for testing under an effective SDoC program?
VI.32. How should OSHA determine the number of inspections to
perform in a given period and how should it target these inspections?
What strategies should OSHA use to maximize the effectiveness and
minimize the resources needed for such inspections?
VI.33. Is OSHA's current enforcement authority sufficient to
support an effective SDoC system in the U.S.? Does OSHA need explicit
statutory authority to issue warnings, notifications of defects or
nonconformity, and/or product recalls and bans? What procedures should
be available to OSHA to enforce these remedies expeditiously while
avoiding inappropriate enforcement action? Are other market controls
needed?
VI.34. Given the importance of accurate manufacturer declarations
to an effective SDoC system, do the OSH Act's current criminal
penalties, or any other applicable Federal criminal statutes, serve as
a sufficient deterrent to making false declarations?
F. Effects on Trade
One of the primary reasons that the EC requested OSHA to consider
SDoC is the EC's belief that the NRTL system is an unnecessary barrier
to trade. Although OSHA considers the trade impacts of its requirements
when developing them, it is interested in any information or analysis
regarding the effect of its NRTL approval requirements or the NRTL
Program on trade.
OSHA believes that its current system facilitates trade. The NRTL
Program has optional procedures in place to avoid duplicating
conformity-assessment of products. These options permit the NRTLs to
accept test results from other parties (including certain product
manufacturers) if the NRTL determines that these parties are qualified.
Through these options, if an EU manufacturer has the qualifications to
do the testing or uses testing performed by a qualified test
laboratory, the NRTL can rely on the testing submitted by the
manufacturer and avoid retesting products. In Europe, there are 250
laboratories or manufacturers that provide testing to NRTLs. In
addition, NRTLs that are members of the internationally recognized
International Electrotechnical Commission Certification Body (IEC-CB)
system may use testing performed by organizations accredited under that
scheme. The IEC-CB system was established in large part to facilitate
trade (both export and import) of electrical products. Under this
system, a manufacturer in one country has its product tested by one of
its country's member laboratories. This laboratory issues a test report
that the manufacturer can submit to a member laboratory in another
country, which will use the report to determine whether to approve the
manufacturer's product for export to that country.
These various options allow NRTLs to rely on other qualified
entities to perform testing and certification. These options can reduce
the cost and time required to obtain product approvals by NRTLs, which
in turn reduces the cost and time to market for products. A NRTL's
responsibility is to ensure the accuracy of the data provided by these
qualified entities. NRTLs work closely with qualified manufacturers,
both large and small, to avoid any unnecessary delays and costs.
Through the following questions, OSHA seeks information on how its
NRTL Program and the EU's system of conformity assessment hinders or
facilitates trade.
VI.35. In considering impacts on trade, how should OSHA compare
SDoC and third-party certification (in particular OSHA's NRTL Program)
to determine if one system adds more value to trade than the other
system? If such comparisons have been made, what is the increase in
value?
VI.36. When comparing SDoC and third-party certification (in
particular OSHA's NRTL Program), is there any reduction in product time
to market for one system compared to other systems? If so, how much
time is saved? Does the time saved vary by product? Is SDoC faster than
third-party certification for some products and slower for others?
VI.37. Please provide specific examples of how each system impacts
trade. Provide any data, if available, on how each system may be a
barrier or a help to trade by affecting product time to market, reduced
profits, or other effects.
G. Implementation Suggestions by Certain Industries
In August 2008, OSHA received a submission from three industry
associations advocating that OSHA permit "safety approvals for a
limited scope of information and communication technology products to
include the use of Supplier's Declaration of Conformity (SDoC) as an
option to (not a replacement for) third-party certification." (Ex.
OSHA-2008-0032-0019.) This submission compliments the EC's proposal by
providing specific suggestions on how OSHA should permit and implement
SDoC. While the focus of this RFI is the EC's proposal, OSHA seeks,
through the following question, comments on the issues and approach
outlined in this industry submission.
VI.38. If OSHA were to implement SDoC, should it follow the
approach in the industry submission, either partially or completely? If
partially, which industry suggestions should OSHA consider? What are
the advantages and disadvantages of the industry approach? Would the
industry approach affect your response to any of the other questions in
this section, and, if yes, how would your response differ? In addition,
please provide any comments you want on issues raised by the industry
submission that are not covered by the questions in this RFI.
VII. Responding to This RFI
OSHA welcomes information, data, and comment on SDoC generally, and
the EC's proposal specifically. OSHA has provided a number of questions
above to provide a framework for the public to respond to this RFI.
However, you can provide comment or information on any aspect of the
broad areas mentioned above, and not limit your answers to the specific
questions posed. In responding to the questions in this RFI, 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. Respondents are encouraged to address
any aspect of the issue on which they believe they can contribute.
Please identify any organization you represent and your position with
that organization, and you may describe any qualifications which you
believe are relevant to your comment. You are free to provide any
information that you believe would be useful to OSHA, including any
data or supporting documentation. However, as noted in section I, OSHA
particularly seeks comments that include specific, detailed, and
credible scientific, technical, statistical, and similar data and
studies that support claims made by commenters.
OSHA will review all timely comments and determine whether to
initiate rulemaking or take other action with respect to SDoC, or to
take no further action.
VIII. Authority and Signature
This document was prepared under the direction of Edwin G. Foulke,
Jr., Assistant Secretary of Labor for Occupational Safety and Health,
200 Constitution Avenue, NW., Washington, DC 20210. 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 October 14, 2008.
Edwin G. Foulke, Jr.
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E8-24826 Filed 10-17-08; 8:45 am]
BILLING CODE 4510-26-P
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