WORLD TRADE  
ORGANIZATION  G/SPS/GEN/640 
20 March 2006 
 (06-1215) 
Committee on Sanitary a nd Phytosanitary Measures  
  
 
ISSUES IN THE APPLICATION OF ARTICLE 6 OF THE AGREEMENT ON THE 
APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES 
 
BACKGROUND DOCUMENT 
 
Note by the Secretariat
1 
 
 
I. INTRODUCTION 
1. The Committee on Sanitary and Phytosanitary Measures (the SPS Committee) initiated 
substantive discussion of problems linked with the im plementation of the provisions for recognition of 
pest- and disease-free areas at the June 2003 SPS Co mmittee Meeting and held informal meetings on 
the issue in 2003, 2004, 2005 and 2006.2   
2. Article 6 of the Agreement on the Application of Sanitary and Phytosanitary Measures (the 
SPS Agreement) states that : 
1. Members shall ensure that their sanitary or phytosanitary measures are 
adapted to the sanitary or phytosanitary char acteristics of the area – whether all of a 
country, part of a country, or all or pa rts of several countries _ from which the 
product originated and to which the product is destined.  In assessing the sanitary or phytosanitary characteristics of a re gions, Members shall take into account, inter alia , 
the level of prevalence of specific diseases or  pests, the existence of eradication or 
control programmes, and appropriate crite ria or guidelines which may be developed 
by the relevant international organizations. 
2. Members shall, in particular, recogni ze the concepts of pest- or disease-free 
areas and areas of low pest or disease prevalence.  Determination of such areas shall be based on factors such as geography, ecos ystems, epidemiological surveillance, and 
the effectiveness of sanitary or phytosanitary controls. 
3. Exporting Members claiming that areas within their territories are pest- or 
disease-free areas or areas of low pest or  disease prevalence shall provide the 
necessary evidence thereof in order to obj ectively 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 prevalence, resp ectively.  For this purpose, reasonable 
access shall be given, upon request, to th e importing Member for inspection, testing 
and other relevant procedures. 
                                                     
 
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to their rights or obligations under the WTO.  
2 See in particular meeting reports:  October 2003 (G/SPS/R/31, paras 90-103);  March 2004 
(G/SPS/R/33, paras 108-119); June 2004 (G/SPS/R/34, paras 83-97);  Oc tober 2004 (G/SPS/R/35, paras 120-
137);  March 2005 (G/SPS/R/36, para s 115-136);  June 2005 (G/SPS/R/37, paras 98-114);  February 2006 
(G/SPS/R/38 and  G/SPS/R/39). G/SPS/GEN/640 
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  3. Committee discussions have focused on two aspect s of regionalization: the establishment of 
pest- or disease-free areas by exporters and the recognition of the pest- or disease-free status by importing countries, although some Members have r ecalled that Article 6 also addresses areas of low 
pest- or disease- prevalence.  Members have submitted papers summarizing their experiences, and proposals for the work programme of the SPS Committee.  The IPPC and the OIE have also submitted 
documents summarizing their activities which provide guidance for countries seeking to establish, or 
to be recognized for pest- or disease-free status.
3 
4. Within the context of the Committee's work in th is area, there are indications that application 
of this concept poses difficulties to Members.  Nume rous  issues raised as  specific trade concerns 
within the SPS Committee relate to the process of recognition of pest- or disease-free status.4  
Furthermore, in the course of Committee discu ssions Members have specifically highlighted 
difficulties in obtaining prompt recognition of their p est- or disease-free status by importing countries.  
Other Members have stressed the need for confiden ce in their trading partners' health status and 
provision of accurate information in their evaluation of requests for recognition of free status.   
5. The resolution of these challenges could involve consideration of the re lationship between the 
work of the SPS Committee and the work of the inte rnational standards setting organizations (ISSBs).  
Members have noted the competent work of the ISSB s and stressed the need to avoid duplication of 
efforts in addressing this issue, as well as the need  to consider expedited recognition procedures in 
cases where the ISSBs have already recognized free status. 
6. In the January 2006 meeting of the SPS Committee, some Members requested that the 
Secretariat prepare a background document on the im plementation of Article 6 of the SPS Agreement 
to further the discussions on this issue.  This b ackground document begins by summarizing Members' 
experiences in the implementation of regionalization.   Next the document highlights the work of the 
IPPC and OIE in this area.  The final section pr ovides a synthesis of Members' proposals concerning 
administrative steps for implementing the concept of regionalization. 
II. MEMBERS' EXPERIENCES 
7. In documents dating back to 1998, Members ha ve provided descriptions of their experiences 
related to the implementation of Article 6 of the SPS Agreement.  Members have highlighted the fact 
that the requirements for implementing the con cept of regionalization differ across importing and 
exporting Members.  Factors which influence an im porting country's acceptance of free status of a 
trading partner include tangible and intangible ch aracteristics of the exporting Members' regulatory 
system which can either generate or erode importing countries' trust.  Four areas in particular have 
been highlighted in the context of Committee di scussions:  (a) the recognition of regions by 
international standards-setting bodies and by Memb ers;  (b) procedures and guidelines for the 
implementation of recognition of the concept of regi onalization;  (c) predictability (or undue delays) 
and (d) transparency. 
A. RECOGNITION  (INTERNATIONAL AND BILATERAL ) 
8. The guidance from the OIE and IPPC is helpful for exporting countries seeking to establish 
and maintain disease- or pest-free areas in a manner that will give importing countries the assurances 
they seek.5  However, recognition by the OIE as having achieved free status in particular diseases 
                                                      
3 A compendium of these documents can be found in document G/ SPS/GEN/636 and Corr.1. 
4 See G/SPS/GEN/204/Rev.5.   
5 United States (G/SPS/GEN/477).  G/SPS/GEN/640 
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  does not necessarily enhance the ability of WT O Members to gain bilateral recognition.6  Some 
Members note that the procedures or information required for verification by the OIE do not fully meet their concerns.  Alternatively, members note that lack of transparency in the process of 
international recognition makes it difficult to determ ine if these information requirements for bilateral 
recognition may in fact be met during the existin g process of international recognition.  Other 
Members emphasize the difficulty of investing adequate resources to meet requirements of both the 
OIE and importing Members, which appear different. 
B. 
PROCEDURES AND GUIDELINES  
9. Given the goal of Members to have areas recognized as pest- or disease-free, the logical 
process to determine how to achieve recognition is to evaluate the underlying procedures and 
guidelines.  Members' experiences indicate that diffic ulties in achieving recognition for free status by 
nature are associated with procedures, including the challenge of adjusting to the procedures of 
different trading partners, as well as delays in the recognition process.7  This broad categorization of 
difficulty has not been considered in sufficient de tail to determine common gaps or overlaps.  All 
agree that recognition as free from pests and disease can generate economic benefits, but how much 
depends on the effectiveness and length of the process.8  Substantial investments may be required to 
achieve and maintain this status.9  Committing to these investments is difficult when the achieving 
trading partners' recognition is unpredictable.  At the same time, trust established through repeated 
interactions between trading partners fac ilitates decisions to recognize free status. 
1. Eradication10 
10. Eradication procedures for specific animal dis ease often follow relevant provisions of the 
OIE's terrestrial code concerning the declaration of free status.  Eradication programmes for animal 
diseases may include some or all of the follo wing components:  vaccination campaigns with 
certification of vaccination status by veterinari ans, outreach programmes to educate the general 
public, epidemiological reporting systems, strengthening of biosecurity measures at the farm level, disinfection of meat packaging facilities (in the case of animal diseases), monitoring and surveillance, 
emergency plan for outbreaks, and the establishment of vaccine reserves.  Eradication programmes for 
plant pests, may include similar activities such as di sinfection of equipment and facilities, chemical or 
biological pesticide treatment, restriction of cropping  and trapping, and lures or other physical control 
methods. 
2. Control and emergency preparedness   
11. Emergency preparedness enhances the ability to ra pidly contain a disease.  Rapid containment 
with strict controls on trade and animal movement can allow the policy of regionalization to continue 
throughout the course of an outbreak.
11  Emergency plans for animal disease may include containment 
procedures, including reinforcement of quaran tine protection along country borders, control on 
movement of animals, the potential for booste d vaccinations, and epidemiological surveys.12  Similar 
approaches to contingency planning that anticipate th e likely introduction of particular plant pests or 
                                                      
6 Argentina (G/SPS/GEN/269/Rev.1);  Brazil (G/ SPS/GEN/584);  Peru (G/SPS/GEN/607) and Chile 
(G/SPS/GEN/610). 
7 Chile( G/SPS/GEN/610). 
8 Peru  (G/SPS/GEN/417 and G/SPS/GEN/418). 
9 Peru  (G/SPS/GEN/607) and Colombia  (G/SPS/GEN/612). 
10 Chile  (G/SPS/GEN/81 and G/SPS/GEN/610);  Argentina   (G/SPS/GEN/315);  Chinese Taipei 
(G/SPS/GEN/402 and G/SPS/GEN/419); European Communities  (G/SPS/GEN/461);  Costa Rica  
(G/SPS/GEN/527);  and Peru  ( G/SPS/GEN/531). 
11 European Communities  (G/SPS/GEN/461). 
12 Peru  (G/SPS/GEN/531) and Chinese Taipei (G/SPS/GEN/419). G/SPS/GEN/640 
Page 4  
 
  pest groups, may be particularly useful in enhanc ing the preparedness of groups that may need to 
cooperate in future eradication programmes.  Systematic and permanent follow-up programmes 
engender trust in the importing country.
13   
3. Surveillance and maintenance 
12. Surveillance systems may include both active surv eillance, in which sampling of populations 
was conducted, and passive surveillance, in which reported disease activity triggered investigations.14  
Monitoring and surveillance strategies related to bot h animals and plant health activities often include 
testing of products from markets and fa rms, and may actively involve farmers.15  For regionalization 
related to plant health, trapping can contribute to the efficient detection of the presence of pests in 
particular regions.16  Flexible surveillance activities in the case of animal health can be important for 
detecting viral activity and quantifying the level of immunity provided by a vaccine.17 
4. Public-private cooperation 
13. Particularly in relation to animal health, eff ective regionalization could be enhanced through 
the involvement of producers, the processing indus try, related professions and representatives of the 
public sector concerned in implementation and training related to achieving free status.18  O n e  
approach to strengthening the private participati on in public sector animal health plans would be 
through accreditation of veterinarians speci alizing in specific animal health areas.19 
C. PREDICTABILITY /TIME 
14. The lack of predictability in recognition of regionalized measures by trading partners makes  
it difficult to commit to the significant medium a nd long-term investments necessary to achieve free 
status. 20  In some cases, the procedure for recognition by importing countries have been delayed 
without technical explanation.21  Furthermore, as noted above, variations in the timing, requirements 
and procedures required by trading partners makes th e application of Article 6 inefficient from the 
perspective of an exporting country.22  Exporting Members may find the treatment of requests for 
recognition unpredictable due to lack of familiar ity with the pest/disease status of the importing 
Member, or with their relevant health service.  Importing Members may have difficulty handling 
requests for recognition due to high numbers of requ ests, lack of familiarity  with the pest/disease 
status of the exporting Member, and  lack of training for adequate analysis. 
D. TRANSPARENCY  
15. Some Members have suggested that Members periodically provide the SPS Committee with 
information on their experience in developing, appl ying, and implementing measures that are adapted 
to regional conditions.23  One proposal suggested a procedure similar to that used for notifying 
equivalence agreements of the recognition, including  a form for the notification of the recognition of 
pest- and disease-free zones, which in principle coul d be submitted by an exporting or an importing 
                                                      
13 Honduras  (G/SPS/GEN/362). 
14 Republic of Korea (G/SPS/GEN/348). 
15 Chinese Taipei (G/SPS/GEN /419) and Peru (G/SPS/GEN/417 and G/SPS/GEN/418). 
16 Mexico (G/SPS/GEN/440/Rev.1). 
17 Argentina (G/SPS/GEN/323 and G/SPS/GEN/ 377) and Nicaragua (G/SPS/GEN/575). 
18 Paraguay  (G/SPS/GEN/413 and G/SPS/GEN/454). 
19 Peru  ( G/SPS/GEN/446). 
20 Peru  (G/SPS/GEN/607). 
21 Argentina  (G/SPS/GEN/433). 
22 Argentina  (G/SPS/GEN606);  New Zealand (G/SPS/W/151). 
23 See in particular Canada (G/SPS/ W/145) and Chile (G/SPS/W/144).  G/SPS/GEN/640 
 Page 5 
 
 
  Member.24  Provision of detailed information by impor ting Members to the Committee regarding their 
questionnaires and evaluation criteria could also e nhance transparency and promote predictability.25 
III. WORK OF THE INTERNATIONAL STANDARDS-SETTING ORGANIZATIONS 
16. The IPPC and the OIE have provided regular updates on their activities in this area.  Both 
organizations have been responsive to request s from the SPS Committee for technical guidance on 
this subject. 
A. IPPC 
17. The IPPC currently has three standards addr essing regionalization:  ISPM 4 on requirements 
for the establishment of pest-free areas;  ISPM  10 on  the establishment of pest-free places of 
production and productio n sites;  and ISPM 22 on requirements for the establishment of areas of low 
pest prevalence.   
18. At the seventh Interim Commission on Phyt osanitary Measures (ICPM) in April 2005, 
agreement was reached to urgently develop a conc ept standard on "Guidelines for the recognition of 
the establishment of pest free areas and areas of lo w pest prevalence".   In October 2005, an Expert 
Working Group produced a draft standard "Guidelines  for the recognition of the establishment of pest 
free areas and areas of low pest prevalence", which included a recommended procedure for 
recognition.26  This procedure included the following series of steps:   
• submission of a request by the National Pl ant Protection Organization (NPPO) of the 
exporting contracting party (CP) for recognition,  together with releva nt information on the 
area of concern; 
• acknowledgement from the NPPO of the importing CP and identification of major omissions 
in the information supplied; description of the recognition process to be used by the NPPO of 
the importing CP, ideally with a provisional timetable;  
• assessment of the technical information and, if  necessary, requests for further information or 
site visits to verify pest status;  
• communication of the result of the assessment to the NPPO of the exporting CP;  and 
• official recognition by the importing CP, if successful. 
 The draft ISPM is intended for consideration by  the CPM Standards Committee in April/May 2006 
and following modification will be sent out for country  consultation.  Approval may be possible at the 
CPM meeting in 2007. 
 
19. The ICPM also decided that a feasibility stud y should be undertaken on the international 
recognition of pest free reas, which would take into  account legal, technical and economic factors and 
assess thr feasibility and sustainability of such system.
27 
20. In addition, the  IPPC has a number of suppor ting standards, such as ISPM 6 "Guidelines for 
surveillance", ISPM 8 "Determination of pest stat us in an area", and ISPM 9 "Guidelines for pest 
eradication programmes".   
                                                      
24 Chile (G/SPS/W/181). 
25 Brazil (G/SPS/W/185). 
26 G/SPS/GEN/626. 
27 See Annex 1 of document G/SPS/GEN/626 for a descri ption of the elements to be covered in this 
feasibility study. G/SPS/GEN/640 
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  B. OIE 
21. The OIE has a mandate to examine, upon request from a member country, its claims for a 
particular status with regard to four of the OIE listed diseases:  foot and mouth disease, rinderpest, contagious bovine pleuropneumonia and bovine spongiform encephalopathy.
28 
22. The OIE Terrestrial Animal Health Code d escribes the requirements for obtaining disease free 
status, including requirements for surveillance a nd monitoring based on the concept of geographic 
zones.  At the 73rd General Session of the OIE in May 2005, member countries of the OIE adopted a 
revised chapter of the Terrestrial Animal Health Code on zoning and compartmentalisation.  This includes  procedures for implementing zoning and comp artmentalisation and a description of the 
process for trading partners to follow in achievi ng recognition of the health status of animal 
subpopulations.
29  For zoning, the recommended steps are as follows: 
• the exporting country identifies a geographical area within its territory which it considers to  
contain an animal subpopulation with a distinct  health status with respect to a specific 
diseases, based on surveillance and monitoring;   
• the exporting country identifies the procedures which are being, or could be, employed to 
distinguish  such an area epidemiologically from other parts of its territory, in accordance 
with the measures stipulated in the Terrestrial Code;  
• the exporting country provides the information a bove to the importing country, and explains 
that the area can be treated as an epidemiol ogically separated zone for international trade 
purposes; 
• the importing country determines whether it may accept such an area as a zone for the 
importation of animals and animal products, taking into account:   
o an evaluation of the exporting country's Veterinary Services; 
o the result of a risk assessment based on the information provided by the exporting 
country and its own research; 
o its own animal health situation with r espect to the disease(s) concerned;  and 
o other relevant OIE standards;  
• the importing country notifies the exporting country  of the result of its determination and the 
underlying reasons, within a reasonable period of time, being either:   
o recognition of the zone; 
o request for further information; or 
o rejection of the area as a zone for international trade purposes; 
• an attempt should be made to resolve any di fferences of opinion over the definition of the 
zone, either in the interim or finally, by usi ng an agreed mechanism to reach consensus (such 
as the OIE dispute settlement mechanism); 
• the importing country and the exporting country ma y enter into a formal agreement defining 
the zone. 
 
23. The OIE has developed a concept paper on compartmentalisation to be discussed at the 
General Session of the OIE In ternational Committee in May 2006.30  This concept paper includes 
description of seven factors for the evaluation and r ecognition of a compartment, as well as a section 
on the recommended sequence of steps to be taken in  defining a compartment, which are similar to 
those steps identified for zoning.   
                                                      
28 Details of the OIE's evaluation and approval proc edure are available in G/SPS/GEN/542 and Add.1. 
29 See G/SPS/GEN/552 for text of the revised standard. 
30 G/SPS/GEN/625.  G/SPS/GEN/640 
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  24. The OIE notes that the application of zoning and compartmentalisation is not mandatory, and 
should only be used when appropr iate, taking into account the epidemiology of the disease and the 
particular factors applying in each situation.  These particular factors may include environmental 
factors, the level of surveillance for the disease, th e quality of veterinary ser vices or other competent 
authorities, and the ability to apply ap propriate biosecurity measures.   
IV. TYPICAL STEPS FOR ADMINISTRATIVE PROCEDURES FOR RECOGNITION:  
SUMMARY OF PROPOSALS31 
25. As previously noted, a number of Member s have submitted proposals regarding the 
administrative process for recognizing pest- or disease-freedom.  Although these proposals vary in a number of requests, there are some common or recurrent elements.  This section of the paper 
identifies these common elements. 
26. The administrative process for achieving bilateral recognition is typically preceded by a 
country eradicating the disease or pest in question and obtaining a particular sanitary or phytosanitary status within part or all of its territory.  
A. E
XPORTING MEMBER REQUESTS ISSB  RECOGNITION  
27. Following this, a country may seek recognition of its status by the competent international 
organization.  Upon obtaining the status of pest- or disease-free area or area of low prevalence, a 
Member officially declares this status (see step K for discussion of expedited procedure).  
B. EXPORTING MEMBER REQUESTS BILATERAL RECOGNITION  
28. Once achieved, the free status is communicated to relevant trading partners along with a 
formal request for recognition of this status , initiating the bilateral process of recognition.32  T h i s  
request for the recognition of a pest- or disease-free area or an area of low pest or disease prevalence 
may be accompanied by science-based and technical  information to support the exporting Members' 
objective demonstration of its sanitary or phytosan itary status, including reference to relevant 
international recognition of free status.  Alternativel y, the initial request could relate to requirements 
and procedure specific to the importing Member, and the technical information could be sent later 
(see step D). 
C. IMPORTING MEMBER CLARIFIES REQUIREMENTS  
29. At the request of the exporting Member, the im porting Member explains the requirements and 
procedures for recognition of sanitary or phytosanitary status with respect to a given pest or disease.  
The importing Member, upon receiving this inform ation, may request answers to a specific 
questionnaire.   
D. EXPORTING MEMBER PROVIDES DOCUMENTATION  
30. The exporting Member sends the technical file  establishing compliance with the requirements 
laid down by the importing Member, accompanied by  an official declaration from the national 
regulatory body attesting that the ecosystem is a pest- or disease-free area or an area of low pest or 
disease prevalence.  Alternatively, the exporting Member provides supporting information showing 
                                                      
31 See in particular Argentina (G/SPS/GEN/60 6); Brazil (G/SPS/W/185);  Chile (G/SPS/W/129, 
G/SPS/W/140/Rev.2 and G/SPS/W/144);  Colombia (G /SPS/GEN/611);  Mexico (G/SPS/GEN/388); Peru 
(G/SPS/W/148). 
32 Chile (G/SPS/W/129). G/SPS/GEN/640 
Page 8  
 
  that the procedures used to obtain recognition are based on an international standard, guideline or 
recommendation established by competent bodies und er the SPS Agreement.  The exporting Member 
also supplies any further information that could he lp the importing Member to reach its decision on 
recognition. 
E. I
MPORTING MEMBER EVALUATES DOCUMENTATION /ADDITIONAL INFORMATION  
31. The importing Member provides feedback to the exporting Member regarding whether the 
documentation is in order.  In addition, the impor ting Member can provide information regarding the 
necessity of additional information, the necessity of  on-site auditing, and suggestion of dates for the 
on-site auditing.  The importing Member may take  into consideration whether the recognition has 
been accorded previously by an international body or by another Me mber when scheduling a technical 
inspection visit. 
32. If the response from the importing Member is negative, the importing Member issues a 
decision rejecting the request and providing reasons .  This allows the exporting Member to modify 
and adapt its system with a view to seeking recognition in the future. 
33. If the response from the importing Member is  positive, the importing Member indicates 
comments where they exist.   
F. EXPORTING MEMBER RESPONDS TO COMMENTS  
34. If the evaluation report contains comments, the exporting Member provides the relevant 
clarifications, additi ons or modifications. 
G. IMPORTING MEMBER EVALUATES DOCUMENTATION  
35. The importing Member provides feedback to the exporting Member regarding responses and 
indicates whether further clarification is necessary.   If further clarification is needed the process 
repeats steps F and G.   
H. IMPORTING MEMBER CONDUCTS ON - SITE EVALUATION  
36. If necessary the importing Member carries out a visit in order to verify the information 
provided in support of the request for recognition of a pest- or disease-free area or area of low 
prevalence.   This technical inspection could consider, inter alia , the administrative structure of the 
regulatory bodies and the programmes they implemen t with a view to  prevention, control and 
eradication.  The strength and credibility of the ve terinary or phytosanitary infrastructure of the 
exporting region(s) would also be  part of this evaluation. 
37. The importing Member indicates comments relating to the inspection visit in an inspection 
report. 
I. EXPORTING MEMBER RESPONDS TO INSPECTION REPORT  
38. If the report of the visit contains comments, the exporting Member provides the relevant 
clarifications, additi ons or modifications. 
J. IMPORTING MEMBER REJECTS OR AUTHORIZES  
39. Where its evaluation and verification of the information provided by the exporting country 
leads to an unfavourable conclusion, the impor ting Member provides technical grounds for the  G/SPS/GEN/640 
 Page 9 
 
 
  decision, so that the exporting Member may modify  and adapt its system with a view to future 
recognition requests. 
40. Where its evaluation and verification of the information provided by the exporting country 
leads to a favourable conclusion, the importing Member launches its internal administrative 
procedures to eliminate the restrictions relating to  the pest or disease associated with the recognition, 
to facilitate trade from the exporting Member that  requested recognition.  The importing Member 
modifies existing regulations or elaborates new ones to  support official recognition of free status.  In 
addition, the importing Member may circulate the m odified or new regulation for public comment.  
The recognition of free status by the importing Member would not preclude the importing Member from taking emergency actions if the status of the exporting Member changes. 
K. E
XPEDITED PROCESS  
41. An expedited process for recognition of sanitary  status could be applied in the following 
situations: 
(a)  When there has been official recogniti on following verification by one of the SPS 
 Agreement's internationa l reference organizations; 
(b)  When there has been an outbreak in a previously recognized area which, once the 
problem was eliminated, was restored to its former status; 
(c)  When the infrastructure and operation of the responsible veterinary or phytosanitary 
service of the exporting Member are sufficiently familiar to the importing Member owing to sanitary or phytosanitary recognitio n with respect to other pests or diseases, 
or to existing trade relations. 
 
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