Document ID: OSHA-2008-0032-0004
Agency: osha
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-10-20T04:00Z

SUMMARY

I. Introduction

On April 30, 2007, the President of the United States, the President of
the European Council, and the President of the European Commission
signed the Framework for Advancing Transatlantic Economic Integration
Between the United States of America and the European Union (EU).  The
agreement’s Annex 1 lists a number of activities affecting different
U.S. and EU agencies and sectors.  One activity listed in the Annex 1 is
“initiating an exchange on conformity assessment procedures for the
safety of electrical equipment.”  Pursuant to this activity in Annex
1, representatives from the Occupational Safety and Health
Administration (OSHA) and two other offices within the Department of
Labor (DOL) met with representatives from the European Commission (EC)
on October 11, 2007, to exchange information concerning their respective
conformity assessment (CA) systems for ensuring the safety of electrical
equipment.  The topics covered by each government’s team are shown in
the attached agenda, and the information presented is summarized below. 
This exchange moved forward the EU and U.S. effort to address the
concerns raised as part of the Framework agreement in particular its
Section II, that aims at rationalizing, reforming, and, where
appropriate, reducing regulations, removing unnecessary differences
between our regulations to foster economic integration.

NOTE: 	As agreed following the meeting, neither the US or EC has edited
the other’s summary.  Also, for brevity, the summaries do not capture
all of the discussions or information covered on a particular topic. 

II. Summary of OSHA’s Information

OSHA generally mandates that electrical products be approved by
Nationally Recognized Testing Laboratories (NRTLs) before these products
― regardless of country of origin ― can be used in a U.S. workplace.
 NRTLs are private organizations that have demonstrated technical
expertise in product safety testing and certification, and their
approvals comprise the testing and certification of particular products.
 OSHA’s NRTL Program determines whether an organization meets the
necessary requirements to be granted “NRTL” status.  OSHA’s
third-party approval requirements constitute a “pre-market” approval
system, which means that all products must be determined to be safe by a
third party before they enter the market.  In making that determination,
the NRTL performs “pre-market inspections” of a product’s
manufacturing process to assure that all units of the product are safe,
and to ensure that the manufacturer is using the NRTL’s certification
mark appropriately.  The NRTL’s control of its mark is fundamental to
assuring that products inspected by the NRTL continue to be safe for use
in the workplace.  The NRTL Program is relied upon by employers and the
public, and by many government and non-government entities in the U.S.
and abroad.  

Throughout the exchange, OSHA’s goal was for both the US and EC to
gain an understanding of the other’s system for regulating and
ensuring the safety of electrical equipment.  This information would
enable OSHA to better understand the foundation and details of the
EC’s proposal for OSHA to consider adopting the EU’s system of
conformity assessment, Supplier’s Declaration of Conformity (SDoC). 
The proposal contained broad statements that OSHA’s requirements are
costly and onerous to trade, in particular to EU exporters.  Thus, OSHA
sought to demonstrate to the EC that OSHA’s third-party system is in
fact “trade-friendly,” containing flexibilities that facilitate
trade.  

OSHA’s Rulemaking Process and Enforcement

OSHA’s mission is to protect the safety and health of American workers
by requiring employers to follow rules that have been developed through
a wholly transparent rulemaking process.  OSHA’s mandate, as set forth
in the Occupational Safety and Health (OSH) Act, is “to assure, so far
as possible every working man and woman in the Nation safe and healthful
working conditions.”  OSHA’s rules, which are called
“standards,” can be imposed only on employers.  These rules must be
promulgated through a public notice and comment process, and must be
based on the “rulemaking record.”

The rulemaking process may begin with a proposal submitted by any of
various sources, including states, advisory committees, and other
stakeholders.  OSHA will often publish a Request for Information (RFI)
or Advance Notice of Proposed Rulemaking (ANPRM) regarding the proposal
in order to solicit more information from other stakeholders about how
the proposed change would affect worker safety and health.  If OSHA
receives enough information supporting a decision to move forward with a
proposal, OSHA will prepare and publish a proposed rule, which is
followed by a hearing.  OSHA then analyzes all the information it has
acquired in order to create a final rule, which is then published.  The
publication of any final rule, standard, or decision must be accompanied
by a full explanation of the reasons for the action, which in turn must
be based on the full record of the rulemaking.

As an example of the above process, the Information Technology Industry
Council (ITIC), a computer industry association, suggested some years
ago that OSHA allow manufacturers to test their own products as an
alternative to third-party approvals for ensuring the safety of
electrical products used in the workplace.  This system of manufacturers
self-testing is commonly referred to as Supplier’s Declaration of
Conformity (SDoC). OSHA analyzed the information it received through an
RFI and concluded that the information received did not justify
initiating rulemaking proceedings to adopt some version of an SDoC
system.

Employers must protect employees even if there is no specific OSHA rule
governing a hazard.  This is stipulated through the General Duty Clause
of the OSH Act, which requires that each employer furnish its employees
a workplace free from recognized hazards likely to cause death or
serious physical harm in addition to complying with all the standards
promulgated by OSHA.  OSHA enforces its standards by inspections of
workplaces.  If the employer is not abiding by OSHA’s standards, OSHA
may issue a citation ordering abatement and imposing penalties.  OSHA
also may make criminal referrals to the U.S. Department of Justice.

OSHA Requirements for NRTL Approval

OSHA’s requirement for third-party approval of electrical products by
Nationally Recognized Testing Laboratories (NRTLs) is set forth under 29
CFR Part 1910, Subpart S. These requirements were originally placed on
employers through the rulemaking process.  OSHA concluded in these
rulemakings that requiring third-party testing of electrical products is
reasonably necessary and appropriate to protect the safety of employees.
 OSHA has twice updated Subpart S, through the notice and comment
rulemaking process, and each time the Agency has maintained the
third-party approval requirements intact.  OSHA requires NRTL approval
of electrical equipment because, among other reasons, such equipment has
many internal components and cannot easily be inspected by a simple
visual examination. 

OSHA’s approval requirement applies equally to all manufacturers,
regardless of country of origin.  Thus, it is trade-friendly in the
sense that the same requirement applies to both domestic and overseas
manufacturers.

OSHA’s Third-party Approval System

NRTLs test certain electrical products and certify that these products
meet consensus-based industry standards of safety to provide assurance
that they are safe for use in the U.S. workplace.  Since its inception
in the early 1970s, OSHA has relied on third-party approval to ensure
that electrical and other specific types of equipment are safe.  The
U.S. has relied on third-party testing for nearly 100 years.  OSHA’s
reliance on NRTLs has been a successful collaboration between government
and private industry that has provided OSHA and employers great
assurance that products are tested appropriately for use in the
workplace. The system is simple, open, low-cost, flexible, and
trade-friendly.  The NRTL Program is the agency’s tool for
implementing the system.

NRTL Product Approval Process 

NRTL product approval is a multi-step process.  First, a product
manufacturer contracts with the NRTL for its testing and certification
services.  Second, the NRTL, or a “qualified party” it has approved
for this purpose, performs initial tests on a sample or prototype of the
product to ensure it conforms to the applicable standards.  (Those
“qualified parties” can be product manufacturers and other
independent labs.)  If the product does not conform, the NRTL requires
the manufacturer to make the necessary corrections and submit the
product for retesting.  This process is repeated until the product
conforms.  When the product passes the safety tests, the NRTL issues a
test report.  Third, the NRTL performs an inspection of the production
line at each facility where the product is manufactured and, if the
quality and technical controls are adequate, certifies the product and
authorizes the use of the NRTL’s certification mark for the product. 
After issuing this authorization, the NRTL performs “follow-up”
inspections of the manufacturing facilities to ensure the manufacturer
continues to produce the product as certified and uses the NRTL’s mark
only as authorized.  If, during these follow-up inspections, any
deviations from the terms approved by the NRTL are found, they must be
resolved or the approval for the use of the mark is revoked.  Qualified
manufacturers can make minor product modifications without pre-approval
by the NRTL.

NRTL factory inspections are not burdensome.  These inspections of
production facilities by the NRTL assure that a manufacturer’s
products are safe before they enter the market and are fundamental
elements of a third-party system.  These inspections can provide this
assurance for 100% of the manufactured products, depending on the type
and potential hazards of the product.

NRTL Program Operations

OSHA’s NRTL Program regulations (29 CFR 1910.7) specify four
performance-based requirements that an organization must meet to obtain
and maintain its NRTL status.  Three broadly define the necessary
technical capability for the testing and certification operations.  The
fourth specifies that the NRTL be completely independent of employers,
manufacturers, and vendors of the items it tests.  This is the
cornerstone of the NRTL Program and key to ensuring that products are
tested appropriately.  There are no elaborate or complicated rules
governing how the program is to be operated; each NRTL determines how it
will conduct its own testing and certification activities, consistent
with general OSHA policies applicable to those activities.  For example,
NRTLs must maintain proper and adequate testing procedures for their
product approval activities.  The NRTL, not OSHA, decides the nature and
extent of the testing procedures needed.  OSHA then reviews these
testing procedures as part of determining if they are adequate.

The NRTL Program involves only two main functions: 1) reviewing and
processing organizations’ applications for recognition under the
program, and 2) auditing the sites of each NRTL annually to ensure it
continues to meet program requirements and to maintain the quality of
their operations.  Through these audits, OSHA ensures the NRTLs are
adequately policing their marks.  Because the number of NRTLs is
relatively small, the program’s staff is also small.  As a result,
annual program costs are less than U.S. $1 million.  

The NRTL Program is open to laboratories from any country and requires
the same data from all applicants.  NRTLs currently operate in the U.S.,
Canada, Europe, and Asia.    Thirty-seven categories of products require
NRTL approval - the largest category being electrical products and
equipment, including those used in hazardous locations.

The NRTL Program is relied upon by all OSHA State-plan states, many
state and local electrical code enforcement authorities, the Consumer
Product Safety Commission, phone companies for equipment certification
requirements, foreign testing organizations under the IEC-CB scheme, and
other government and private accreditation organizations.  Most
important is the reliance on the NRTL system by employers and employees
to ensure the products they purchase are safe.  

Product Safety Test Standards

The NRTL system requires the use of product safety test standards of
U.S. standards organizations.  NRTLs can use the harmonized version of
these standards, which deviate in varying respects from the
international version due to country-specific requirements.  The U.S.
harmonized versions are commonly published by Underwriters Laboratories
and the American National Standards Institute.  OSHA requires that the
test standards used by NRTLs be consistent with U.S. national consensus
standards and codes and be developed under a fair and open consensus
process.  Input to these standards is provided primarily by industry and
other interested parties.

Enforcement of the Use of NRTLs’ Marks

NRTLs do not enforce OSHA requirements; instead, they enforce the use of
their own certification marks.  Only NRTL marks are acceptable in U.S.
workplaces.    Each NRTL enforces the use of its mark through contracts
with the manufacturers that require initial testing of the product and
the periodic inspections of the manufacturing facilities.  During
initial testing, the NRTL ensures that the product meets the
requirements of the applicable consensus-based standards.  As part of
this step, it will require all major components to either be tested or
to already bear a specific NRTL mark.  If components change
subsequently, the manufacturer must inform the NRTL.  During
inspections, NRTLs assure that the components of the product have not
changed.  This control is in place even if the products are manufactured
in another country.  The nature and frequency of the NRTL’s
inspections provide the assurance that a manufacturer continues to
produce products that are safe.

NRTLs, not OSHA, conduct “post-market” surveillance, including
testing of purchased products.  Each NRTL, and not OSHA, determines the
type of post-market activities it will undertake and the procedures it
will follow for this surveillance.  

Flexibilities to Facilitate Trade

The NRTL Program has optional procedures in place to avoid duplication
of the conformity assessment of products.  These options permit the
NRTLs to accept test results from either one of its own recognized
sites, other facilities under control of this recognized site, or other
“qualified parties,” including independent laboratories and the
product manufacturers themselves.  .

Through these options, if an EU manufacturer has the qualifications to
do the testing or has used testing done by a qualified test lab, the
NRTL can rely on the testing submitted by the manufacturer and avoid any
retesting.  In Europe alone, there are 250 labs or manufacturers that
provide testing to NRTLs.  In addition, NRTLs that are members of the
internationally recognized IEC-CB scheme may use testing performed by
organizations accredited under that scheme.  This scheme was
established, in large part, to facilitate trade (export or import) of
electrical products.  Under this scheme, a manufacturer in one country
has its product tested by one of its country’s member labs.  This lab
issues a test report that the manufacturer can use to have its product
approved for export to another country by presenting the report to a
member lab of that country.

These various options allow NRTLs to rely on other qualified entities to
perform testing and certification.  This can reduce the cost and time
required to acquire NRTL product approvals which in turn reduces the
cost and time-to-market for products requiring NRTL approval.  The
NRTL’s responsibility is to ensure the accuracy of the data provided
from these qualified entities.  NRTLs work closely with qualified large
and small manufacturers to avoid any unnecessary delays and costs.

OSHA is planning to propose an adjustment to the NRTL program which
would introduce additional flexibility. The proposed change would allow
NRTLs to use “satellite” sites to do product certification in
addition to testing; currently such sites can only test, but cannot
certify, products.  These “satellite” sites may be operated by the
NRTL or by another organization under the NRTL’s control.  This
proposed program responds to industry concerns about delays in getting
products certified, but does not compromise the safety of the approved
product.

OSHA’s 2005 RFI Regarding a Proposed SDoC System

OSHA issued a Request for Information in November 2005 regarding a
proposal from the Information Technology Industry Council (ITIC), an IT
industry association, to adopt SDoC for IT equipment.  The ITIC proposal
asserted that an SDoC system would reduce time-to-market delays imposed
by different countries’ differing requirements.  However, the proposal
provided no information to explain these differences.  The industry
hoped that OSHA’s adoption of SDoC would positively influence other
countries in their deliberations on what conformity assessment scheme to
implement.  

The purpose of the RFI was to gather information to help OSHA adequately
understand the workings of existing SDoC systems and operations,
including their basic purpose, their comparative costs and benefits, and
their problems and limitations.  The RFI also sought information
addressing the validity of the claims in the ITIC proposal.  

The process yielded little data and confirmed that, to ensure any degree
of safety of products in an SDoC system, the government must conduct
aggressive post-market surveillance, which OSHA does not currently have
authority to perform.  The OSH Act does not include specific provisions
for OSHA to conduct product recalls and bans and to implement other
necessary elements of this post-market surveillance system.

OSHA analyzed all the information gathered through the RFI process and
concluded that no data was presented that justified a change to an SDoC
system.  As a result, OSHA decided to take no further action on the ITIC
proposal.

III. Summary of EC’s Information

In the EU all products must be determined to achieve a high level of
safety before they enter the market.  The EU obliges manufacturers to
certify their own products and maintain a technical file regarding the
product’s safety for inspection by surveillance authorities.  There is
no obligation to use third parties in the certification process, but the
technical file must contain evidence that the product complies with the
safety objectives, either through trustworthy (e.g. accredited) tests or
through other evidence (e.g. a comprehensive safety analysis of the
product’s design).  Under EU law, this is referred to as “internal
production control”.  The more widely used term is Supplier’s
Declaration of Conformity (SDoC).  There is no need for an additional
layer of recognition of test laboratories on top of the already existing
accreditation mechanisms.  

The EC’s goals for the meeting were not only to exchange factual
information about the two systems, but to have OSHA: 1) consider the
impact of EU and U.S. regulations on the broader context of
international trade; and 2) look towards the removal of barriers to
transatlantic commerce that are caused by duplication of procedures and
foster economic integration by reforming regulations and eliminating
differences between the two systems.

The EC raised the issue of proportionality.  In the EU, type approval is
only used in areas, where without such approval the risks to consumers
and workers would be high and liability and consumer protection
legislation would not be a sufficient deterrent for manufacturers to
place unsafe products on the market.  The safety record of electrical
(including electronic and ICT products) is however such that risks to
users are low.  A type approval regime therefore does not provide added
value in terms of increased user safety as is demonstrated by the fact
that in the EU a very high level of safety has been reached.  Electrical
safety is not an issue in the EU, which is confirmed by statistics.  The
US cannot demonstrate that its system performs any better than the EU
system.  Especially ICT and other electronic products have a very high
safety record.  Based on a 30 year long experience they conclude that an
SDoC system achieves the same level of safety but with less red tape and
costs for manufacturers than a third-party system.

On a voluntary basis European manufacturers use third-party testing
where such is necessary to demonstrate compliance, notably in relation
to product liability.  A healthy certification industry has continued to
flourish.  In the absence of internal expertise, small manufacturers
tend to outsource testing.  Voluntary 3rd party schemes like the German
GS scheme exist.

Market Access in the European Union: the Low Voltage and R&TTE
Directives

The EC sees the dialogue with OSHA in an international context.  The EU
and U.S. are the two most important trading blocs in the world. 
Regulatory convergence on certification between the two blocs would set
a benchmark against which regulations from 3rd countries, notably China
could be evaluated.  EU and US (and 3rd country) industries are being
faced with a growing amount of technology regulation that causes
unnecessary trade costs.  They call for the establishment of regulatory
environments implementing, wherever possible the "one requirement, one
test, acceptance everywhere" paradigm.  Trade costs are caused by lack
of commonality in regulation.  The EC wants to enter in dialogue with
OSHA in order to converge approaches.  It asks the US to rethink its
system in order to address this matter.

The EC is not arguing that the US system does not fulfill its purpose. 
It is however disproportionate and trade unfriendly.  From its
experience it concludes that obligatory third-party approval of these
products including production control is an unnecessary layer for
conformity assessment that can be eliminated without affecting consumer
or workers safety.  In response to a concern of DOL that SDoC could
require more government resources for enforcement, the EC indicated that
in their experience on balance the benefits of SDoC (shorter time to
market, lower certification costs, maintenance of safety levels,
reduction of trade barriers) outweighed the costs (reorientation of
enforcement from CABs to government bodies, transition).  An important
issue to address is the financing of enforcement.  A correctly designed
SDoC system should however not require substantial surveillance
activity.  If that were the case, SDoC would not have been justified.

The trend in the EU towards SDoC derived from the need to establish the
internal market.  The Low Voltage Directive (LVD) which was adopted in
1973 and now covers 2 million products/year was a precursor for many
other Directives.  The EC reported that only a very small percentage of
products regulated by the LVD are reported to have problems with
compliance.  A few of these have led to recalls to withdraw them from
the market.  The EC however observes that recalls are happening in any
regulatory system, including the US NRTL and other regimes.

The LVD covers all electrical equipment between 50 and 1000 volts (AC)
and 75 and 1500 volts (DC).  The decision of where to set these limits
was policy-based.  The lower limits were meant to exclude the telecom
industry, whose equipment operates at 48 volts and below, and the upper
limits were meant to exclude the power industry, whose equipment
operates above 1000 volts.  The statistics show that LVD-covered
products show a very high level of compliance.  The risk of consumers
getting into touch with dangerous products is low.

When the LVD was issued, there were only 6 Member States in the EU.  It
was fully implemented by 1973 and was meant to promote the free movement
of goods across the EU.  The Member States cannot add requirements to
those set by the Directive.  They can however regulated public interest
requirements, that would not be safety related.

In the EU electrocutions have become rare and are in the vast majority
of cases due to product misuse or carelessness, not product design.  The
low number confirms that the SDoC system is performing well at ensuring
a high level of safety.  Within the EU incident statistics are collected
nationally and these are coherent in this respect.  Less than 2% of
post-market surveillance actions relate to electrical and ICT equipment.
 No deaths have been recorded over the past 10 years from the
non-compliance of such equipment with one exception of gross neglect
that would have happened in any regulatory system.  Highest levels of
non-compliance have been reported on Christmas lights and kitchen
appliances, where preemptive measures have been taken.

The EC discussed its “New Approach” on technical regulation and
standardization, which was a means to support a political decision that
all of Europe would operate as a single market.  This decision was made
in 1985, to be in effect by 1992.  Most EU product Directives are
following the principles of the New Approach.  The Directives are
binding upon Member States and have to be transposed in national law. 
If the Member States do not implement or do not properly implement the
Directive, they have to accept products complying with the Directive. 
The Directives are adopted by the Council of Ministers and the European
Parliament, and name objectives rather than technical specifications.

The translation of the objectives to technical specifications has been
delegated to the European Standardisation Organisations (ESOs).  These
are private-sector bodies.  Standardisation is mainly financed by the
private sector but the organisations receive subsidies from public
authorities to maintain their infrastructure.  This is similar to ANSI
(American National Standards Institute).  In certifying a product, a
manufacturer using use either the EU harmonized standard or other
methods to comply with the Directive.  If a manufacturer complies with
the harmonized standards, it is presumed to have complied with the
Directive.  Otherwise, the manufacturer has the burden, if challenged
during a post-market inspection, to prove that he has met the
requirements of the Directive.  In cases where the manufacturer cannot
be found, the burden passes to the importer, who can be liable for
penalties such as fines.  Fines are levied by the Member States, and are
not harmonised, meaning that different Member States have different fine
amounts.

The EU has a policy to ensure that its standards align with
international standards.  Eighty percent of Europe’s standards in the
electrical sector are identical with standards.  Through agreements of
European Standardisation Organisations there is parallel voting of
international and European standards.  In the area of plugs and sockets
some national "A-deviations" remain for historical reasons.  This is an
area, where there is no full harmonisation as it would be overcostly to
harmonise in this field.

There are different approaches to conformity assessment and what is
required for a product to qualify for using the CE mark.  Products in
Module A require only internal control of production.  This is the SDoC
system.  There are also Modules B through H, with the products in Module
H requiring “full quality assurance.”  Products like medical devices
and elevators require generally 3rd party involvement.  Market
surveillance is necessary in each module.  Where there is an ex ante
control of the product there is in general also a production control
procedure, either through factory visits or sampling..  There are
different emphases on post-market surveillance for different modules. 
For products in Module A, which are considered low-risk it is deemed
that production controls are unnecessary and that it is sufficient to
control the market through post-market surveillance.  This has proven to
be correct for electrical and especially electronic and ICT products. 

The EU system of post-market surveillance continues to be under is the
responsibility of the Member States.  The EU observed differences in the
level of enforcement effort and funding between Member States and
recently agreed minimum standards that have to be achieved. 
Surveillance can involve a review of the technical documentation for the
product, or sending the product to a lab for testing to see if the
product is clearly safe or unsafe.  If those results show that the
product is non-compliant, the manufacturer may have to pay the testing
costs.  Non-compliant does not imply that there would be an immediate
risk for consumers.  If the product does not achieve a high level of
safety, the country may bar its sale, following which an EU concertation
takes place to assert, whether the product should be barred from the EU
market.  For products posing immediate safety risks the EU has a rapid
alert system (RAPEX)..  This system is however increasingly also used
for communicating non-compliant products.  Another notification system,
called ICSMS has this purpose but is not used by all Member States.  Its
purpose is to exchange information on non-compliant products.  Aim of
future legislation is to bring more harmonization into the system.

Under the LVD, a manufacturer is responsible for maintaining full
technical files of his products at least 10 years after the product is
put on the market.  Those files include test results, product design
documentation, and the standards that were applied in designing the
product.

The CE mark means that a product complies with the terms of the
applicable product Directive and not that it conforms to any particular
EU safety standard.  The mark will be legally protected, which will
facilitate action against illegal affixing of the mark.  The CE mark is
young and replaced many national markings.  Consumer awareness and
confidence took a period to develop, is still growing and is at a
satisfactory level.

Given the lack of harmonization of methods to collect statistics on
electrical accidents, any comparison of statistics between the US and
the EU, or even between Member States within the EU is difficult. 
Statistics that were gathered for  the United States, Germany, and
Finland showed however that the number of accidents decreased steadily
for all three countries and were at a comparable level.  A sharp drop
was visible since the 70's, when both the OSHA NRTL system and the LVD
came into force.  This can be attributed to the progress of the state of
the art of the electrical and electronic industries, which is a further
argument in favor of a rule change.

The EC reminded OSHA of the calls from both the EU and US industries to
render market access regimes trade friendly. Barriers to trade caused by
divergent regulatory systems should be mitigated by either regulatory
convergence, deregulation or Mutual Recognition Agreements (MRA). 
Convergence involves regional agreements to harmonize product
requirements and a common conformity assessment regime.  The EU
Directives ensure common regimes with the EU, but are also implemented
in 3rd countries, sometimes through bilateral agreements.  The EU
regretted the fact that OSHA had not honoured the US commitments
deriving from the EU-US MRA.

The EU elaborated on its perception of market access costs for EU
industry to access the US market.  Whilst sizing such costs is a
difficult exercise it had made a rough estimate based on direct
compliance costs + costs caused by delays in time to market.  That
calculation would lead to a figure of $1,3 billion over a 5 year period.
 They invited the US for more data based on their surveillance of the
NRTL program.

IV. Concluding Remarks

All the participants of the meeting agreed that it had been very
productive.  However, due to lack of time, neither side was able to ask
all of its questions.  OSHA and the EC did not set any specific date to
meet again.  OSHA said it would put together a record of this meeting
and share it with the EC for input.  OSHA and the EC would decide what
the next step would be.AGENDA

Meeting date/time:  	Thursday, October 11, 2007, 10:00 a.m. to 5:00 p.m.
EDT

Meeting location: 	Room C5515, Frances Perkins Building, 200
Constitution Ave, N.W. Washington DC

Purpose of meeting:   To accomplish Annex 1 B.f (Initiating an exchange
on conformity assessment procedures for the safety of electrical
equipment.) from the Framework for Advancing Transatlantic Economic
Integration Between the United States of America and the European Union.

General Duration of Agenda Items

10:00 a.m. to 10:45 a.m.: Opening remarks (including introductions,
Ground Rules)

10:45 a.m. to 12:00 p.m.: OSHA’s topics

12:00 p.m. to 12:30 p.m.: Lunch

12:30 p.m. to 1:30 p.m.: OSHA’s topics (continued)

1:30 p.m. to 2:45 p.m.: EC’s topics

2:45 p.m. to 3:00 p.m.: Break

3:00 p.m. to 4:00 p.m.: EC’s topics (continued)

4:00 p.m. to 5:00 p.m.: Closing remarks (including conclusions, record
of meeting)



Details of OSHA’s topics

Overview of OSHA’s requirements for approval (i.e., conformity
assessment) of electrical equipment (including general information on
OSHA’s rulemaking process and enforcement of its rules)

Overview of the workings of the OSHA Nationally Recognized Testing
Laboratory (NRTL) Program

Questions from OSHA representatives regarding the EC’s July 2007
statement advocating OSHA adoption of SDoC:

Supporting details of EC’s SDoC safety track record

Explanation of EC’s view regarding OSHA requirements as a barrier to
trade

Supporting details for EC’s figure for costs savings for SDoC

Supporting details for EC’s claim of time burden

Information gathered from OSHA’s November 2005 RFI of SDoC

Questions from the European Commission (EC) representatives on OSHA’s
information

Details of EC’s topics

Overview of European Union’s (EU’s) requirements concerning
conformity assessment of electrical equipment

Actual operation of EU’s Supplier’s Declaration of Conformity (SDoC)
system

Differences between Member States (MS) requirements concerning
conformity assessment of electrical equipment

Description of MS product registration requirements

Description of  MS enforcement activity

Questions from OSHA representatives regarding EC’s information

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upplier’s Declaration of Conformity for electrical and ICT
equipment”.  Submitted to Mr. Allan Hubbard, U.S. co-chair of the
Framework Agreement’s Transatlantic Economic Council.

U.S.-EU Framework Agreement

Meeting Between the Occupational Safety and Health Administration (OSHA)
and the European Commission (EC)

October 11, 2007

Summary and Agenda (finalized 8/19/08)

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