1. 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

2. 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 Committee’s 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.

3. ISO 4254-1 (Agricultural machinery – Safety - Part 1: General requirements)
The EC has indicated it will not recognize ISO 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 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.

4. 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 45020:1998 (Guide ISO/IEC 2:1996) 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.

5. 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 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.

6. 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.

7. 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.

8. 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 :2005 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 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. 

9. 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-of–step 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.