ANSI Conference on U.S. Leadership

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ISO Global Relevance Case ISO/TC 23/SC 3 ISO
4254-1

• ANSI Conference on U.S. Leadership
• in ISO and IEC
• Presented by
• Mr. Steven P. Cornish
• Director, International Policy
• American National Standards Institute

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• The Issue
• The type of guards that should be installed to
  avoid the risks related to access to moving
  transmission parts.  This discussion focused on
  two points
• the need for locked or interlocked guards,
  depending on the type of access to be prohibited,
  and
• the characteristics of the fixed guard (whether
  or not it can be removed with a tool).
• The Committees Solution
• The experts (including European industry experts)
  agreed that
• a requirement would be incorporated in the main
  body of the standard, that was generally
  supported worldwide, and
• a normative Annex C will specify the additional
  European requirements to ensure compliance when
  necessary with Annex I of the EC Machinery
  Directive.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• The EC has indicated it will not recognize ISO
  4254-1 as a harmonized standard meeting the
  requirements of the EC Machinery Directive.
• EC Reason 1 A note in an ISO standard
  indicating use of an annex in order to meet the
  EC Machinery Directive has no normative value.  A
  standard that includes a choice of different
  safety levels accompanied by notes specifying the
  options that are applicable in Europe allows a
  manufacturer to choose an option which may
  conflict with the EC Machinery Directive.
• ANSI Response While a note in an ISO standard
  has no normative value, the fact that the annex
  to ISO 4254-1 is designated as normative makes
  the annex a normative element of the standard for
  application in the European market and in
  relation to the EC Machinery Directive.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• EC Reason 2 The purpose of the standard is to
  record the state of the art defined in EN
  450201998 (Guide ISO/IEC 21996) as "the
  developed stage of technical capability at a
  given time as regards products, processes and
  services, based on the relevant consolidated
  findings of science, technology and experience". 
  Its purpose is not to provide designers with a
  set of disparate solutions, some of which reflect
  the previous state of the art.
• ANSI Response It is now widely recognized in
  the discussion on global relevance that technical
  capability can vary not just from one given point
  in time to another, but also at one given point
  in time in different markets or countries based
  on a variety of factors and conditions.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• EC Reason 3 The existence, in a standard, of
  options not providing the same level of safety is
  liable, at international level, to create a
  distortion of competition that is detrimental to
  those manufacturers who choose the most demanding
  option.  There is therefore a high risk that less
  safe machines would enjoy the same freedom of
  circulation as safe ones.
• ANSI Response Industry experts will continue to
  debate what provides the greatest level of safety
  - locked or interlocked guards, depending on the
  type of access to be prohibited, and the
  characteristics of the fixed guard (whether or
  not it can be removed with a tool).  However, for
  the European market, the requirements of the EC
  Machinery Directive must be respected and
  therefore the normative annex of ISO 4254-1 must
  be applied.  No distortion of competition can be
  expected to result, nor would one expect to see
  products circulating in Europe that do not comply
  with the requirements of the EC Machinery
  Directive.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• EC Reason 4 The possibility that a
  manufacturer might choose one of the technical
  requirements recommended by the standard when
  such requirements do not provide an equivalent
  level of safety, goes against the purpose of the
  EC Machinery Directive which is to ensure the
  free movement of goods and products within the
  European Union, whilst at the same time
  guaranteeing that the product design incorporates
  a high level of safety.
• ANSI Response Please see our response to EC
  Reason 3.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• EC Reason 5 In the EC Declaration of
  Conformity, the manufacturer indicates the
  reference of the harmonized European standard
  used.  Unless it is mandatory to explicitly
  mention the reference to the specifically
  European part of the standard, there is nothing
  to differentiate between a manufacturer who
  applies the EN option and one who applies one or
  more of the other options.  This creates an
  element of doubt, whereas the presumption of
  conformity should guarantee to all interested
  parties (manufacturers, users, notified bodies,
  public authorities responsible for market
  surveillance) that a machine designed according
  to a harmonized standard meets the regulatory
  requirements of the EC Machinery Directive.
• ANSI Response The EC Machinery Directive, while
  describing the contents of the Declaration of
  Conformity, does not require the manufacturer to
  make a reference to harmonized standards that may
  have been applied to the design.  The
  manufacturer is free to do so, but the
  listing of applied standards is not required. 
  The EC Machinery Directive requires that the
  manufacturer or his authorized representative
  declare compliance to the essential provisions of
  the EC Machinery Directive, and nothing more. 
  Even when a harmonized standard is shown on the
  Declaration of Conformity, the mere listing is
  not an indication that presumption of conformity
  exists for the entire machine.  That is because
  the presumption only applies to those relevant
  Essential Health and Safety Requirements that
  have been addressed by the harmonized standards.
  Many harmonized EN standards do not address
  certain EHSRs for one reason or another.  In such
  cases there is no presumption of conformity with
  respect to the EHSRs that have not been addressed
  in the harmonized standard.

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• Considerable efforts have taken place to discuss
  these concerns with the EC and attempt to resolve
  them such that ISO and CEN may adopt the same
  standard.
• ISO agreed to proceed and published ISO
  4254-12005 on 1 August 2005, and CEN immediately
  launched a ballot on the adoption of the ISO
  text, European foreword and Annex ZA.  This
  ballot is scheduled to close on 4 November 2005.
• While it is possible that publication of a
  separate EN based on but different in some
  requirements from ISO 4254-1 could be an option,
  it is one that experts believe should be
  considered only when all other possibilities have
  been exhausted.
• ANSI is concerned that this position of the EC
  will set a precedent that could have negative
  implications for other ISO global relevance cases
  and the desired harmonization of ISO and CEN
  standards. 

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ISO 4254-1(Agricultural machinery Safety -
Part 1 General requirements)

• The EC position may have the effect of undoing
  approximately 15 years of effort under the
  ISO/CEN Vienna Agreement to seek harmonization of
  ISO and CEN standards and to seek every
  opportunity to ensure the same standards are
  adopted by ISO and CEN.
• The EC position is out-of-step with the needs and
  consensus view of European industry.
• The EC position is out-ofstep with the
  developing worldwide consensus on and commitment
  to global relevance.
• The EC position may result in European standards
  that do not comply with WTO TBT criteria for
  globally relevant standards that are
• responsive to scientific and technical
  developments in various countries,
• do not distort markets,
• have no adverse effects on fair competition,
• do not stifle innovation and technological
  development, and
• do not give preference to characteristics or
  requirements of specific countries or regions
  when different needs or interests exist in other
  countries or regions.
• The EC position may result in CEN standards that
  are not globally relevant and are therefore
  unsuitable for adoption by ISO.