WORLD TRADE  
ORGANIZATION  G/SPS/GEN/605 
5 December 2005 
 (05-5781) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
  
THE IMPLEMENTATION OF ARTICLE 6 (REGIONALIZATION) OF THE  
AGREEMENT ON THE APPLICATION OF SANITARY AND  
PHYTOSANITARY MEASURES 
  
Submission by Japan
 
   The following communication, received on 30 November 2005, is being circulated at the 
request of the Delegation of Japan. 
 
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I. BACKGROUND 
1. Articles 2.2 and 5.1 of the Agreement on the Application of Sanitary and Phytosanitary 
Measures (SPS Agreement) require Members to ensu re that their sanitary and phytosanitary measures 
are based on scientific principles and an appropriate risk assessment.  
2. "Regionalization" is recognized in Article 6 of the SPS Agreement.  At the same time, 
Article 6.3 stipulates that "Exporting Members claimi ng that areas within their territories are pest- or 
disease-free areas or areas of low pest or disease pr evalence shall provide the necessary evidence 
thereof in order to objectively demonstrate to the importing Member that such areas are, and are likely 
to remain, pest- or disease-free areas or areas of low pest or disease prev alence, respectively". 
3. With regard to the relevant international standards: 
 The OIE has recommendations on the concept of "regionalization (zoning)" in the "Terrestrial 
Animal Health Code" and the "Aquatic Animal H ealth Code".  Although the Codes admit that 
the steps generally depend on the circumstances existing within the Members involved, they 
have specified the recommended steps for the recognition of disease-free areas.  However, the 
technical and administrative requirements for each step are not clearly distinguished.  The Terrestrial Animal Health Code  also establishes the concept of "compartmentalization".  With 
regard to "compartmentalizati on", we understand that an explan atory paper is being prepared 
by the OIE in order to develop a mutual understanding among Members. 
  On the other hand, the IPPC has standa rds which describe the requirements for the 
establishment of pest-free areas or ar eas of low pest prevalence:  " Requirements for the 
establishment of pest-free areas" (Internationa l Standards for Phytos anitary Measures (ISPM 
No.4) ";  "Requirements for the establishment of p est-free places of production and pest-free 
production sites (ISPM No.10)";  and "Requirements for the establishment of areas of low 
pest prevalence (ISPM No.22)" .  The IPPC is also developing a technical standard on 
requirements for the establishment of free areas for a specific pest:  "Requirements for the G/SPS/GEN/605 
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 establishment and maintenance of pest-f ree areas for tephritid fruit flies" , and an 
administrative standard which will describe the recognition process of pest-free areas or areas 
of low pest prevalence, " Guidelines for the recognition of the establishment of pest-free areas 
and areas of low pest prevalence" .  The IPPC has developed technical guidelines and closely-
related administrative guidelines in order to ensu re the efficacy of implementing both types of 
guidelines. 
 4. In order to encourage discussions on the issue of  "regionalization" in a well-balanced manner 
between importing and exporting Members, we w ould like to communicate the following experiences 
and views on this issue to the Committee and share them with other Members. 
II. EXPERIENCE IN THE RECOGNITION OF PEST- OR DISEASE-FREE AREAS OR 
AREAS OF LOW PEST OR DISEASE PREVALENCE 
5. In the area of animal quarantine, Japan has recognized disease-fre e areas primarily for 
classical swine fever (CSF) in light of the intern ational standards.  Currently CSF-free areas are 
recognized in three countries. 
6. In the area of plant quarantin e, Japan has recognized pest-free areas and pest-free places of 
production for Mediterranean fruit fly in three countries and a pest free area for the Melon fly in one country so far.  
7. As for the establishment of pest- or disease -free areas and areas of low pest or disease 
prevalence, it is indispensable for the importing countries to understand the animal and plant quarantine system and the status of the enforcement of the system in the exporting countries.  For that 
understanding, we think it important to accumulate e xperiences of recognition.  With this in mind, we 
recognize that the international standards are impor tant tools for "regionalization", i.e., pest- or 
disease-free areas or areas of low pest or disease prevalence. 
III. JAPAN’S VIEW ON THE RECOGNITION OF PEST- OR DISEASE-FREE 
COUNTRIES OR AREAS 
8. Article 6 of the SPS Agreement is an essential el ement of the scientific approach to trade-
related regulations as well as to  other provisions of the SPS Agreement.  The introduction of the 
concept of "regionalization", on the basis of scientific evidence, mak es it possible to enhance 
domestic health protection as well as to improve ma rket access for products from regions which meet 
the appropriate level of protection. 
9. We consider that the roles and responsibilities of the SPS Committee, the relevant 
international organizations and Members in the implementation of Article 6 are the following; 
(a) The SPS Committee is responsible for the interpretation of the SPS Agreement and 
the supplementary decisions in order for th e Members to ensure that any sanitary and 
phytosanitary measure is not applied in a manner which constitutes a disguized restriction on international trade.  
(b) The relevant international organizations ar e responsible for developing technical and 
scientific criteria or guidelines regard ing the establishment, assessment and 
recognition of pest- or disease-free areas and low pest or disease prevalence. 
(c) Members are responsible for applying the pr inciple of Article 6, exchanging data 
between exporting and importing Members and determining the SPS measure that achieves the appropriate level of sanitary or phytosanitary protection.  G/SPS/GEN/605 
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 10. In the discussions of the SPS Committee, some  Members expressed the view that a Member 
should automatically observe the recognition of disea se-free countries or areas by the OIE.  However, 
Japan points out that it is difficult to suppor t this view for the followings as reasons: 
(a) According to Article 3.3 of the SPS Agreement, a Member may introduce or maintain 
sanitary or phytosanitary measures which r esult in a higher level of sanitary or 
phytosanitary protection than would be ach ieved by measures based on the relevant 
international standard, if there is a scientif ic justification, or other requirements are 
met.  This is the case with the OIE standard , which is the international standard under 
the SPS Agreement, and Members need not necessarily follow the OIE standard in 
their adoption of sanitary and phytosanita ry measures and recognition of disease-free 
countries or areas if there is a scientific justification.   
(b) Even if a Member adopted sanitary and ph ytosanitary measures identical to the OIE 
standard, the right should be accorded to the Member to make a final decision in its recognition of the disease-free countries or areas,  since that decision is directly linked 
to sanitary and phytosanitary measures th at are taken based on each Member’s own 
risk assessment.   
(c) Furthermore, in the recognition of di sease-free countries or areas, a Member’s 
decisions, as the exercise of its right, should be fairly respected since they are based 
on the thorough research, including on-site inspection, of the applicant Member’s actual condition of disease and its potential impact on trade, while the OIE’s judgement is conducted merely in terms of its consistency with the OIE standard, on 
the basis of on-desk examination of doc uments/data submitted by the applicant 
Member.  Therefore, it is appropriate that a Member use OIE’s recognition of disease-free countries or areas as a good reference but not necessarily observe it unconditionally. 
11. With regard to "regionalization", some Me mbers share the view that the SPS Committee 
should develop administrative guidelines.  However,  we believe that Members should examine the 
following points. 
(a) Technical guidelines and administrative guidelines are closely interrelated in 
"regionalization". 
(b) If the SPS Committee starts to develop administrative guidelines on this issue, while 
various international standards on the same issue are developed by the international 
standard-setting bodies, duplication of work and confusion among Members could 
happen. 
12. As we said in paragraph 5, the recognition of pest- or disease-free areas or areas of low pest 
or disease prevalence requires the understanding of th e animal and plant quarantine system and the 
status of the enforcement of the system in the ex porting countries.  Therefore, as was the case with 
equivalence and Article 4 of the SPS Agreement, we  believe that the international standard-setting 
bodies should develop guidelines including both techni cal and administrative aspects.  Furthermore, 
we think it important to review these guid elines based on the experiences of Members. 
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