. /.  WORLD TRADE  
ORGANIZATION  G/SPS/GEN/477 
16 March 2004  
 
(04-1139) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
   
 
REGIONALIZATION 
 
Communication by the United States
 
 
 
 The following communication, dated 15 March 2004, is being circulated at the request of the 
Delegation of the United States.  
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1. The United States applies the concept of regionalization both in reaching import 
determinations and to facilitate e xports with regard to animal and plant products.  Application of 
regionalization actually predates the WTO SPS Ag reement.  In 1987, USDA-APHIS amended its 
regulations to establish criteria under which the im portation of fruits and vegetables from “definite 
areas or districts” would be allowed.  Since th at time, USDA-APHIS has recognized numerous pest-
free or low prevalence areas, facilitating pl ant or plant product imports as a result. 
2. In 1997, APHIS published a statement setting out its policy regarding recognition of animal 
disease freedom on the basis of areas defined by factors other than national borders.  The policy statement identified specific factors affecting the di sease risk of a region that APHIS considers in its 
evaluation, such as livestock demographics, diagno stic laboratory capabilities, and the disease status 
of adjacent regions.  These factors have b een incorporated into APHIS regulations 
(http://www.access.gpo.gov/nara/cfr/wa isidx_03/9cfr92_03.html).  
1. Experience and Observations 
3. Drawing on our experience in regionalization,  the United States would like to share the 
following observations: 
• Any regionalization decision must consider the strength and credibility of the 
veterinary or phytosanitary infrastructure of the exporting region(s).  The veterinary 
or plant health authorities must demonstr ate their ability to maintain freedom from 
specified pests or diseases to create th e necessary confidence on the part of the 
importing country.  A key element in this is  credibility as well as timely, consistent 
and accurate disease and pest reporting, as called for under the OIE and the IPPC.   
 
• Regionalization decisions must be based on science and a risk assessment that takes 
into account the biology of the particular pest or disease at issue and an evaluation of the veterinary or phytosanitary infrastructur e in the exporting region.  In addition, the 
availability of appropriate risk management  options will influence the regionalization 
determination. 
 G/SPS/GEN/477 
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• The availability and quality of scientific info rmation will dictate to a great extent the 
length of time and the complexity of the risk assessment.  In some cases, it is necessary to gather appropriate surveilla nce or other information to support a 
regionalization request.  The willingness of th e exporting country to collect and share 
this information can significantly affect the time required. 
 
• Regionalization decisions must be reached in an open and transparent manner, 
allowing relevant input from all interested parties. 
 
• Disease or pest outbreaks may occur in area s that had attained freedom.  The United 
States recently proposed amending its regiona lization approach to address situations 
where an area, previously recognized as fre e, has had an outbreak but regained its 
free status (G/SPS/N/USA/763).  While it is necessary to evaluate how the outbreak 
occurred and was subsequently eradicated, ma ny elements such as the strength of the 
infrastructure, may already be known. 
 
2. Activities of the International Standard Setting Bodies 
4. The United States considers that the relevant international standard-setting bodies, the OIE 
and IPPC, are the appropriate bodies to undertake the task of developing guidelines for reaching 
regionalization decisions.  The OIE and the IPPC pos sess the necessary technical expertise to consider 
the multitude of factors that must be examined, su ch as the biological nature of pests or diseases, 
inefficiencies in the exchange of relevant data, and the ability of the exporting country to demonstrate 
the effectiveness of its disease eradication and control programs. 
5. The OIE does, upon request and in the context of OIE standards, evaluate members' status 
with respect to Foot and Mouth Disease, Rinderpes t, and Bovine Spongiform Encephalopathy.  The 
IPPC, however, does not conduct similar evaluations  of plant pest status among its members.  
Changes to the functions performed by the OIE and IPPC must be decided upon through the appropriate mechanisms of these bodies. 
6. For exporting countries
:  The relevant OIE and IPPC standards point out that the 
establishment of pest or disease free areas is an effort or procedure undertaken by an exporting 
country for the purposes of international trade.  Th ese standards are very helpful in showing exporting 
countries how to establish and maintain disease or pest  free areas in a manner that will give importing 
countries the assurance they seek.  Participation in the work of the OIE and IPPC, and timely 
reporting of disease or pest outbreaks, contribute significantly to building the credibility importing 
countries must rely upon in making regionalization decisions. 
7. For importing countries :  The United States considers that the existing standards of the OIE 
and IPPC related to risk assessment are the star ting point for more specific guidance for importing 
countries evaluating requests for regionalization.  This guidance could help Members improve the 
transparency and consistency of the scientific evalua tions related to regiona lization determinations.  
The OIE and the IPPC possess the necessary techni cal expertise to develop such guidelines, and 
provide the appropriate forum for this work. 
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