WORLD TRADE  
ORGANIZATION  G/SPS/GEN/640/Rev.1 
14 September 2006 
 (06-4389) 
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 
 
Revision  
 
 
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 regi on, 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 
                                                      
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 Corr.1 and  G/SPS/R/39 and Corr.1, paras 121 146), March 2006 (G/SPS/R/40, paras 72-78 
and June 2006 (to be circulated as G/SPS/R/42). G/SPS/GEN/640/Rev.1 
Page 2  
 
  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. 
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 Members, although some Members have recalled 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 Members 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.  Nu merous 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 pest- or disease-free status by importing 
Members.  Other Members have stressed the need for confidence 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 implementin g the concept of regionalization.  The original version of the 
paper was discussed at the March and June 2006 meet ings of the SPS Committee and has been revised 
to take into account comments received from Members. 
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 Member's acceptance of trading partner's 
pest- or disease-free areas include tangible and inta ngible characteristics of the exporting Members' 
regulatory system which can either generate or erode importing Members' trust.  Four areas in 
particular have been highlighted in the contex t of Committee discussions:  (a) the recognition of 
regions by international standards-setting bodies an d by Members;  (b) procedures and guidelines for 
the implementation of recognition of the concept of  regionalization;  (c) predictability (or undue 
delays) and (d) transparency. 
                                                      
3 A compendium of these documents can be  found in document G/SPS/GEN/636/Rev.1.  
4 See G/SPS/GEN/204/Rev.6 and addenda.    G/SPS/GEN/640/Rev.1 
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  A. RECOGNITION  (INTERNATIONAL AND BILATERAL ) 
8. The guidance from the OIE and IPPC is helpful for exporting Members seeking to establish 
and maintain disease- or pest-free areas in a manne r that will give importing Members the assurances 
they seek.5  However, recognition by the OIE as having achieved free status in particular diseases 
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.7  Alternatively, Members note that l ack of transparency in the process of 
international recognition makes it difficult to determ ine if the requirements for bilateral recognition 
may in fact be met during the existing process of international recognition.  Other Members 
emphasize the difficulty of investing adequate resources to meet requirements of both the OIE and 
importing Members, which may be different.  All Members recognize that the ultimate decision to 
recognize regionalization remains with  the importing Member and depends, inter alia,  on the trust in 
the competent authority of the exporting Member.8 
B. PROCEDURES AND GUIDELINES  
9. Members' experiences indicate that many diffi culties in achieving recognition of pest- or 
disease-free areas are associated with procedures, including the challenge of adjusting to the 
procedures of different trading partners, as well as delays in the recognition process.9  All agree that 
recognition of an area as free from certain pests or  diseases can generate ec onomic benefits, but how 
much benefit depends in part on the eff ectiveness and length of the recognition process.10  Substantial 
investments may be required to achieve and maintain this status.11  Committing to these investments is 
difficult when the subsequent recognition of fr eedom by trading partners is unpredictable.12  At the 
same time, trust established through repeated in teractions between trad ing partners facilitates 
decisions to recognize free status. 
1. Eradication13 
10. Eradication procedures for a specific animal disease 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 followi ng components:  emergency vaccination campaigns, 
outreach programmes to educate the general publ ic, epidemiological surveillance and reporting 
systems, strengthening of biosecurity measures at the farm level, disinfection of meat packaging 
facilities, contingency plans for outbreaks, imposition of official movement controls and the depopulation of farms.   
11. The IPPC does not now provide specific guidance for most pests, but it has developed the 
more general ISPM 9 "Guidelines for pest eradi cation programmes".  Eradication programmes for 
plant pests may include activities such as disinfection of equipment and facilities; chemical or 
                                                     
 
5 United States (G/SPS/GEN/477);  EC (G /SPS/W/190);  Grenada (G/SPS/W/194). 
6 See for example Argentina (G/SPS/GEN/269 /Rev.1);  Brazil (G/SPS/GEN/584);  Peru 
(G/SPS/GEN/607);  Chile (G/SPS/GEN/610). 
7 Japan (G/SPS/W/192). 
8 European Communities (G/SPS/W/1 90);  Grenada (G/SPS/W/194). 
9 Chile (G/SPS/GEN/610). 
10 Peru  (G/SPS/GEN/417 and G/SPS/GEN/418). 
11 Peru  (G/SPS/GEN/607);  Colombia  (G/SPS/GEN/612). 
12 Egypt (G/SPS/W/193;  Grenada (G/SPS/W/194). 
13 Australia (G/SPS/W/191);  Argentina   (G/SPS/GEN/315);  Chile  (G/SPS/GEN/81 and 
G/SPS/GEN/610);  Chinese Taipei (G/SPS/G EN/402 and G/SPS/GEN/419);  Costa Rica  (G/SPS/GEN/527);  
European Communities  (G/SPS/GEN/461);  Peru  (G/SPS/GEN/531). G/SPS/GEN/640/Rev.1 
Page 4  
 
  biological pesticide treatment;  restriction of cropping;  trapping lures or other physical control 
methods;  destruction of host plants;  disinfestations;  and communication. 
2. Control and emergency preparedness
14     
12. Emergency preparedness enhances the ability to  rapidly contain a disease or pest.  Rapid 
containment with strict controls on trade and moveme nt of animals and/or plants and host plants can 
allow the policy of regionalization to continue th roughout the course of an outbreak.  Contingency 
plans for outbreaks may include containment pr ocedures such as reinforcement of quarantine 
protection along country borders, cont rol on movement of animals and/or plants and host plants, the 
potential for emergency vaccination, and epidemiologi cal surveys.  Similar approaches to contingency 
planning that anticipate the likely introduction of pa rticular pests or diseases may be particularly 
useful in enhancing the preparedness of groups th at may need to cooperat e in future eradication 
programmes.  Systematic and permanent follow- up programmes engender trust in the importing 
Member.   
3. Surveillance and maintenance 
13. Surveillance systems may include both active surv eillance, in which sampling of populations 
is conducted, and passive surveillance, in which reports of ill animals trigger investigations.15  
Monitoring and surveillance strategies related to both animal and plant health activities often include 
testing of products from markets and fa rms, and may actively involve farmers.16  For regionalization 
related to plant health, trapping can contribute to the efficient detection of the presence of pests in 
particular regions.17  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.18 
4. Public-private cooperation 
14. Effective regionalization could be enhanced through the involvement of producers, the 
processing industry, related professions and repr esentatives of the public sector concerned in 
implementation and training rela ted to achieving free status.19  In relation to animal health, one 
approach to strengthening private sector participatio n in public sector animal health plans would be 
through accreditation of veterinarians specializing in specific animal health areas.20  One component 
of managing and reducing the risks posed by exot ic pests and diseases can be to develop close 
industry and government partnerships, including thro ugh the development of cost sharing agreements 
for some issues and review (or development) of i ndustry-specific biosecurity plans.  These preemptive 
planning processes can improve the capacity to main tain domestic and international trade, negotiate 
access to new overseas markets and reduce the so cial and economic costs of disease and pest 
incursions on both producers and the wider community.21 
C. PREDICTABILITY /TIME 
15. As noted above, the lack of predictability in recognition of regionalization by trading partners 
makes it difficult to commit to the significant me dium and long-term investments necessary to 
                                                      
14 Australia (G/SPS/W/191); Chinese Taipei  (G/SPS/GEN/419); European Communities  
(G/SPS/GEN/461);  Honduras  (G/SPS/GEN/362);  Peru  (G/SPS/GEN/531). 
15 Republic of Korea (G/SPS/GEN/348). 
16 Chinese Taipei (G/SPS/GEN/419);  Pe ru (G/SPS/GEN/417 and G/SPS/GEN/418). 
17 Mexico (G/SPS/GEN/440/Rev.1). 
18 Argentina (G/SPS/GEN/323 and G/SPS/GE N/377);  Nicaragua (G/SPS/GEN/575). 
19 Paraguay  (G/SPS/GEN/413 and G/SPS/GEN/454). 
20 Peru  ( G/SPS/GEN/446). 
21 Australia (G/SPS/W/191).  G/SPS/GEN/640/Rev.1 
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  achieve free status. 22  Furthermore, variations in the timi ng, requirements and procedures required by 
trading partners make the application of Article 6 inefficient from the perspective of an exporting 
Member.23  Since regionalization depends on the pest and/or disease status of both the exporting and 
the importing area, familiarity with the importing Me mber's pest/disease status and with its relevant 
health service may help reduce unpredictability.  
16. Importing Members may have difficulty handling requests for recognition due to high 
numbers of requests, lack of familiarity with the pest/disease status of the exporting Member, resource 
constraints and lack of training for adequate analysis.  Assessment of requests for recognition of pest- or disease-free areas (or areas of lo w prevalence) is usually part of a broader import risk assessment 
addressing a range of pests and/or diseases.  Time ta ken to complete certain steps in the assessment 
process may vary on a case-by-case basis, depending on the complexity and technical aspects of the 
situation being evaluated and on the quality of the data provided by the exporting Member.
24   
D. TRANSPARENCY25 
17. Throughout the recognition process, transparency  is of central importance.  An exporting 
Member needs to have a transparent system to gain the trust of the importing Member, while the 
importing Member's transparency regarding re quirements and procedures can facilitate the 
recognition process. 
18. 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, or that they briefly info rm the Committee when they have concluded the 
recognition of the pest- or disease status of a particular area.  Others have proposed a procedure 
similar to that used for notifying recognition of eq uivalence, including a form for the notification of 
the recognition of pest- and disease-free areas, which in principle could be submitted by an exporting 
or an importing Member.  Provision of detailed in formation by importing Members to the Committee 
regarding their questionnaires and evaluation criteri a could also enhance transparency and promote 
predictability.  Alternatively, Members coul d publish such detailed in formation on a website, 
including information on the status of individual recognition processes. 
III. WORK OF THE INTERNATIONAL STANDARDS-SETTING ORGANIZATIONS 
19. 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 
20. The IPPC currently has three standards addr essing regionalization:  ISPM 4 on requirements 
for the establishment of pest-free areas;  I SPM 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.  In addition, the IPPC has a number of supporting standards, such as ISPM 6 
"Guidelines for surveillance", ISPM 8 "Determinati on of pest status in an area", and ISPM 9 
"Guidelines for pest eradication programmes".   
                                                      
22 Peru  (G/SPS/GEN/607). 
23 Argentina  (G/SPS/GEN606);  New Zealand (G/SPS/W/151). 
24Australia (G/SPS/W/191); Korea (G/SPS/W/1 95); Japan (G/SPS/W/192); Chinese Taipei 
(G/SPS/W/205). 
25 See Argentina, Brazil, Colombia, Ecuador,  Paraguay and Uruguay (G/SPS/W/189); Brazil 
(G/SPS/W/185); Canada (G/SPS/W/145); Chile (G/SPS/W/144 and 181); European Communities 
(G/SPS/W/190). G/SPS/GEN/640/Rev.1 
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  21. 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 low 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 CPM Standards Committee considered the draft ISPM in May 2006 and agreed to send it out for 
country consultation.
27  Adoption may be possible at the CPM meeting in 2007. 
 
22. The CPM also adopted terms of reference fo r a feasibility study on the international 
recognition of pest free areas, which would take in to account legal, technical and economic factors 
and assess the feasibility and sustainability of such  system.  Due to the scarcity of available 
information on existing pest-free areas and taking into account the financial situation of the IPPC, the 
CPM agreed that during 2006 the IPPC secretariat would collect data for presentation at the CPM 
meeting in 2007.  The CPM will then decide how to proceed. 28 
B. OIE 
23. 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.
29 
24. The OIE Terrestrial Animal Health Code describes the requirements for obtaining disease-
free status for a country, zone or compartmen t, including requirements for surveillance and 
timeframes based on the characteristics of the disease.  At the 74th General Session of the OIE in May 
2006, member countries of the OIE made minor revisions to the chapter of the Terrestrial Animal Health Code on zoning and compartmen talization.  This chapter includes  procedures for 
implementing zoning and compartmentalization and a description of the process for trading partners 
to follow in achieving recognition of the h ealth status of animal subpopulations.
30  For zoning, the 
recommended steps are as follows: 
                                                      
26 G/SPS/GEN/626. 
27 G/SPS/GEN/707. 
28 Annex 1 of document G/SPS/GEN/707 contains the terms of reference for the feasibility study, to be 
reviewed at the CPM meeting in 2007. 
29 Details of the OIE's evaluation and approval proc edure are available in G/SPS/GEN/542 and Add.1. 
30 See G/SPS/GEN/552 for text of the standard as adop ted in 2005.  The most cu rrent revised version is 
available from the OIE website www.oie.int.   G/SPS/GEN/640/Rev.1 
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  • the exporting country identifies a geographical area within its territory which it considers to 
contain an animal subpopulation with a distinct hea lth status with respect to a specific disease, 
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 ot her 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. 
 
25. The OIE has published a concept paper on compartmentalization.31  This concept paper 
includes description of seven factor s for the evaluation and recognition 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.  This  paper will be examined by the Terrestrial Code 
Commission in October 2006 to evaluate whether there are aspects that could be used to improve the 
current Code chapter on zoning and compartmentalization. 
26. The OIE notes that the application of zoning a nd compartmentalization is not mandatory, and 
should only be used when appropr iate, taking into account the epidemiology of the disease and the 
particular factors characterizing 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 appropriate bio security measures.  The OIE is planning to publish 
a disease-specific practical guide for the application of compartmentalization using avian influenza in 
poultry as an example.  
                                                     
 
31 A provisional draft of the concept paper is contained in document G/SPS/GEN/625.  The final paper 
has been published in OIE Bulletin 2006-2 and is available from the OIE website. G/SPS/GEN/640/Rev.1 
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  IV. TYPICAL STEPS FOR ADMINISTRATIVE PROCEDURES FOR RECOGNITION:  
SUMMARY OF PROPOSALS
32 
27. As previously noted, a number of Member s have submitted proposals regarding the 
administrative process for recognizing pest or di sease freedom.  Although these proposals vary in a 
number of respects, there are some common or recurrent elements.  This section of the paper 
identifies these common elements. 
28. A few Members have indicated that they cons ider the guidance from the OIE and the IPPC 
described in Section III above to be sufficient and th at they wish to avoid duplication in the work of 
the SPS Committee and that of the intern ational standard-setting organizations.33  
29. The administrative process for achieving bilate ral recognition typically commences by an 
exporting Member deciding to seek recognition of a pest- or disease-free area.  This may occur in 
situations where a pest or disease has never been found in the area and the Member considers that 
formal recognition of its pest- or disease-free status would be beneficial.  Alternatively, the decision 
to seek recognition of pest or disease freedom may fo llow successful efforts to eradicate the pest or 
disease in question.  Where applicable, a Member may seek recognition of the pest or disease status of 
an area by the competent international organizati on, although this is not a precondition for bilateral 
recognition (see step J for discussion of expedited pr ocedure).  The steps below address the bilateral 
process of recognition of a pest- or disease-free area or of an area of low pest or disease prevalence.34  
For the importing Member, recognition of regional c onditions is usually one part of the overall 
process of establishing a sanitary or phytosanitary  measure.  Beginning the recognition process with a 
bilateral discussion of the procedure to be fo llowed, specifying the documentation required and 
indicative timeframes for administrative steps, can  enhance predictability an d help to avoid undue 
delays.  The guidance prepared by the OIE and IPPC can provide a useful basis for this discussion. 
30. The bilateral procedures followed may or may not be formally established by the importing 
Member.  It has been suggested th at bilateral agreement on the procedures to be followed, through, for 
example, an exchange of letters or memorandum of understanding, could help make the procedure 
more transparent and predictable.   
31. Some Members have also suggested that the identification of expected or maximum time 
periods for the various steps of the recognition procedur e would be useful to ensure its predictability.  
These could be established bilaterally on a case-by-case  basis or across-the-board to provide more 
general administrative guidance.  
32. Finally, the need for discussion and coordina tion between officials responsible for trade 
policy matters and the technical animal and plan t health experts in both the importing and the 
exporting Member has been highlighted. 
                                                      
32 See in particular Argentina (G/SPS/GEN/606) ;  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).  The following Members have provided co mments on the initial version of this section of the 
document: Argentina, Brazil, Colombia, Ecuador, Paraguay and Uruguay (G/SPS/W/189);  Australia 
(G/SPS/W/191 and Add.1);  Egypt (G/SPS/W/193);  European Communities (G /SPS/W/190);  Grenada 
(G/SPS/W/194);  Japan (G/SPS/W/192);  Korea (G/SPS /W/195);  Chinese Taipei (G/SPS/W/205);  United 
States (G/SPS/W/199). 
33 For a comparison of the steps contained in G/SPS/GEN/640 and in the relevant OIE and IPPC 
standards, see New Zealand's document G/SPS/GEN/698/Rev.1. 
34 Article 6 refers both to pest- or disease-free areas and to areas of low pest or disease prevalence.  
Although some or all of the steps described in this section may be applicable to the recognition of areas of low pest or disease prevalence, the focus of the Committee's discussions has been on recognition of pest- or disease-
free areas.  G/SPS/GEN/640/Rev.1 
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  A. EXPORTING MEMBER REQUESTS IN FORMATION ABOUT PROCEDURES AND /OR BILATERAL 
RECOGNITION  
33. The exporting Member requests information a bout the importing Member's requirements and 
procedures.  An exporting Member may either re quest information about an importing Member's 
requirements prior to formally requesting recognition of  its pest- or disease-free area, or at the time it 
initiates the bilateral process of recognition.  In this latter case, the expor ting Member would at the 
same time communicate its pest or disease status to  relevant trading partners along with its formal 
request for recognition of this status.  This 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 Member's objective demonstration of its sanitary or 
phytosanitary status, including reference to relevant international recognition of this status.  It may be 
helpful to indicate the body and individual responsib le for the recognition process, and to request that 
the importing Member do the same.   
B. I
MPORTING MEMBER CLARIFIES REQUIREMENTS  
34. At the request of the exporting Member, the im porting Member explains its requirements and 
procedures for recognition of sanitary or phytosanitary status with respect to a given pest or disease.  
The importing Member may, for example, request answ ers to a specific questionna ire.  In the interest 
of transparency, the importing Member may indicat e the body and individual responsible for handling 
the request. 
C. EXPORTING MEMBER PROVIDES DOCUMENTATION  
35. 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 area is pest- or  disease-free or of low pest or disease prevalence.  
Alternatively, the exporting Member provides supp orting information showing that the procedures 
used to obtain recognition of that area are based on an inte rnational 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. 
D. IMPORTING MEMBER EVALUATES DOCUMENTATION /ADDITIONAL INFORMATION  
36. 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 sugg est dates for the on-site 
auditing.  The importing Member may take into co nsideration whether recognition has been accorded 
previously by an international body or by another Member. 
37. 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. 
38. If the response from the importing Member is  positive, the importing Member indicates 
comments where they exist.   
E. EXPORTING MEMBER RESPONDS TO COMMENTS  
39. If the evaluation report contains comments, the exporting Member provides the relevant 
clarifications, additi ons or modifications. G/SPS/GEN/640/Rev.1 
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  F. I
MPORTING MEMBER EVALUATES DOCUMENTATION  
40. 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 E and F.   
G. IMPORTING MEMBER CONDUCTS ON - SITE EVALUATION  
41. 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 implem ent 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. 
42. The importing Member indicates comments relating to the inspection visit in an inspection 
report provided to the exporting Member. 
H. EXPORTING MEMBER RESPONDS TO INSPECTION REPORT  
43. If the report of the visit contains comments, the exporting Member provides the relevant 
clarifications, additi ons or modifications. 
I. IMPORTING MEMBER REJECTS OR AUTHORIZES  
44. Where its evaluation and verification of the information provided by the exporting Member 
leads to an unfavourable conclusion, the impor ting Member provides technical grounds for the 
decision, so that the exporting Member may modify  and adapt its system with a view to future 
recognition requests. 
45. Where its evaluation and verification of the information provided by the exporting Member 
leads to a favourable conclusion, the importing Member launches its internal administrative 
procedures to modify the restrictions relating to th e 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 mo dified or new regulation for public comment.   
46. The recognition of a pest- or disease-free area or of an area of low pest or disease prevalence 
by the importing Member would not preclude the importing Member from ta king emergency actions 
if the status of the exporting Member changes. 
J. EXPEDITED PROCESS  
47. An expedited process for recognition of sanitary  status could be applied in the following 
situations, taking into account the importing Member's  right to ensure that its appropriate level of 
protection is achieved: 
(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 in accordance with the 
relevant international standard;  G/SPS/GEN/640/Rev.1 
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  (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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